Sample records for random effect odds

  1. Technology diffusion in hospitals: a log odds random effects regression model.

    PubMed

    Blank, Jos L T; Valdmanis, Vivian G

    2015-01-01

    This study identifies the factors that affect the diffusion of hospital innovations. We apply a log odds random effects regression model on hospital micro data. We introduce the concept of clustering innovations and the application of a log odds random effects regression model to describe the diffusion of technologies. We distinguish a number of determinants, such as service, physician, and environmental, financial and organizational characteristics of the 60 Dutch hospitals in our sample. On the basis of this data set on Dutch general hospitals over the period 1995-2002, we conclude that there is a relation between a number of determinants and the diffusion of innovations underlining conclusions from earlier research. Positive effects were found on the basis of the size of the hospitals, competition and a hospital's commitment to innovation. It appears that if a policy is developed to further diffuse innovations, the external effects of demand and market competition need to be examined, which would de facto lead to an efficient use of technology. For the individual hospital, instituting an innovations office appears to be the most prudent course of action. © 2013 The Authors. International Journal of Health Planning and Management published by John Wiley & Sons, Ltd.

  2. Primary repair of penetrating colon injuries: a systematic review.

    PubMed

    Singer, Marc A; Nelson, Richard L

    2002-12-01

    Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

  3. Efficacy and Safety of Oral and Transdermal Opioid Analgesics for Musculoskeletal Pain in Older Adults: A Systematic Review of Randomized, Placebo-Controlled Trials.

    PubMed

    Megale, Rodrigo Z; Deveza, Leticia A; Blyth, Fiona M; Naganathan, Vasi; Ferreira, Paulo H; McLachlan, Andrew J; Ferreira, Manuela L

    2018-05-01

    This systematic review with meta-analysis was performed to evaluate the efficacy and safety of using opioid analgesics in older adults with musculoskeletal pain. We searched Cochrane Library, MEDLINE, EMBASE, Web of Science, AMED, CINAHL, and LILACS for randomized controlled trials with mean population age of 60 years or older, comparing the efficacy and safety of opioid analgesics with placebo for musculoskeletal pain conditions. Reviewers extracted data, assessed risk of bias, and evaluated the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. Random effects models were used to calculate standardized mean differences (when different scales were used across trials), mean differences and odds ratios with respective 95% confidence intervals (CIs). Meta-regressions were carried out to assess the influence of opioid analgesic daily dose and treatment duration on our main outcomes. We included 23 randomized placebo-controlled trials in the meta-analysis. Opioid analgesics had a small effect on decreasing pain intensity (standardized mean difference = -.27; 95% CI = -.33 to -.20) and improving function (standardized mean difference = -.27, 95% CI = -.36 to -.18), which was not associated with daily dose or treatment duration. The odds of adverse events were 3 times higher (odds ratio = 2.94; 95% CI = 2.33-3.72) and the odds of treatment discontinuation due to adverse events 4 times higher (odds ratio = 4.04; 95% CI = 3.10-5.25) in patients treated with opioid analgesics. The results show that in older adults suffering from musculoskeletal pain, using opioid analgesics had only a small effect on pain and function at the cost of a higher odds of adverse events and treatment discontinuation. For this specific population, the opioid-related risks may outweigh the benefits. The systematic review shows that, in older adults suffering from musculoskeletal conditions, opioid analgesics have only a small effect on pain and disability. Conversely, this population is at higher risk of adverse events. The results may reflect age-related physiological changes in pain processing, pharmacokinetics, and pharmacodynamics. Copyright © 2017 The American Pain Society. Published by Elsevier Inc. All rights reserved.

  4. Meta-analysis of Odds Ratios: Current Good Practices

    PubMed Central

    Chang, Bei-Hung; Hoaglin, David C.

    2016-01-01

    Background Many systematic reviews of randomized clinical trials lead to meta-analyses of odds ratios. The customary methods of estimating an overall odds ratio involve weighted averages of the individual trials’ estimates of the logarithm of the odds ratio. That approach, however, has several shortcomings, arising from assumptions and approximations, that render the results unreliable. Although the problems have been documented in the literature for many years, the conventional methods persist in software and applications. A well-developed alternative approach avoids the approximations by working directly with the numbers of subjects and events in the arms of the individual trials. Objective We aim to raise awareness of methods that avoid the conventional approximations, can be applied with widely available software, and produce more-reliable results. Methods We summarize the fixed-effect and random-effects approaches to meta-analysis; describe conventional, approximate methods and alternative methods; apply the methods in a meta-analysis of 19 randomized trials of endoscopic sclerotherapy in patients with cirrhosis and esophagogastric varices; and compare the results. We demonstrate the use of SAS, Stata, and R software for the analysis. Results In the example, point estimates and confidence intervals for the overall log-odds-ratio differ between the conventional and alternative methods, in ways that can affect inferences. Programming is straightforward in the three software packages; an appendix gives the details. Conclusions The modest additional programming required should not be an obstacle to adoption of the alternative methods. Because their results are unreliable, use of the conventional methods for meta-analysis of odds ratios should be discontinued. PMID:28169977

  5. Effects of Housing First on Employment and Income of Homeless Individuals: Results of a Randomized Trial.

    PubMed

    Poremski, Daniel; Stergiopoulos, Vicky; Braithwaite, Erika; Distasio, Jino; Nisenbaum, Rosane; Latimer, Eric

    2016-06-01

    Housing First is emerging as an evidence-based practice for housing and supporting people who are homeless and have a mental illness. The objective of this study was to determine whether Housing First increases the odds of obtaining competitive employment in this population and affects income, including income from informal and illegal sources. A total of 2,148 people with a mental illness were recruited from five Canadian cities while they were homeless, classified as having moderate or high needs, and randomly assigned to Housing First or usual care. Housing First participants with high needs received assertive community treatment (ACT), and those with moderate needs received intensive case management (ICM). Every three months, participants were interviewed about employment and earnings in the previous months (median follow-up=745 days). Regression models were estimated via generalized estimating equations. ICM recipients had lower odds of obtaining employment compared with the control group with moderate needs. The odds of obtaining employment among ICM recipients increased but their employment rate never exceeded that of the control group. For ACT recipients, the odds of obtaining employment were not significantly different from those of the control group. Among Housing First participants, persons employed at baseline, men, and younger participants had greater odds of employment compared with control participants. Housing First did not appear to significantly increase income. This was the first large-scale randomized controlled study of Housing First's effects on employment. Further research is needed to determine how Housing First may be enhanced to increase odds of obtaining employment.

  6. Artemisinin derivatives for treating severe malaria.

    PubMed

    McIntosh, H M; Olliaro, P

    2000-01-01

    Artemisinin derivatives may have advantages over quinoline drugs for treating severe malaria since they are fast acting and effective against quinine resistant malaria parasites. The objective of this review was to assess the effects of artemisinin drugs for severe and complicated falciparum malaria in adults and children. We searched the Cochrane Infectious Diseases Group trials register, Cochrane Controlled Trials Register, Medline, Embase, Science Citation Index, Lilacs, African Index Medicus, conference abstracts and reference lists of articles. We contacted organisations, researchers in the field and drug companies. Randomised and pseudo-randomised trials comparing artemisinin drugs (rectal, intramuscular or intravenous) with standard treatment, or comparisons between artemisinin derivatives in adults or children with severe or complicated falciparum malaria. Eligibility, trial quality assessment and data extraction were done independently by two reviewers. Study authors were contacted for additional information. Twenty three trials are included, allocation concealment was adequate in nine. Sixteen trials compared artemisinin drugs with quinine in 2653 patients. Artemisinin drugs were associated with better survival (mortality odds ratio 0.61, 95% confidence interval 0.46 to 0.82, random effects model). In trials where concealment of allocation was adequate (2261 patients), this was barely statistically significant (odds ratio 0.72, 95% CI 0.54 to 0.96, random effects model). In 1939 patients with cerebral malaria, mortality was also lower with artemisinin drugs overall (odds ratio 0.63, 95% CI 0.44 to 0.88, random effects model). The difference was not significant however when only trials reporting adequate concealment of allocation were analysed (odds ratio 0.78, 95% CI 0.55 to 1.10, random effects model) based on 1607 patients. No difference in neurological sequelae was shown. Compared with quinine, artemisinin drugs showed faster parasite clearance from the blood and similar adverse effects. The evidence suggests that artemisinin drugs are no worse than quinine in preventing death in severe or complicated malaria. No artemisinin derivative appears to be better than the others.

  7. Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis.

    PubMed

    Nixon, R M; Bansback, N; Brennan, A

    2007-03-15

    Mixed treatment comparison (MTC) is a generalization of meta-analysis. Instead of the same treatment for a disease being tested in a number of studies, a number of different interventions are considered. Meta-regression is also a generalization of meta-analysis where an attempt is made to explain the heterogeneity between the treatment effects in the studies by regressing on study-level covariables. Our focus is where there are several different treatments considered in a number of randomized controlled trials in a specific disease, the same treatment can be applied in several arms within a study, and where differences in efficacy can be explained by differences in the study settings. We develop methods for simultaneously comparing several treatments and adjusting for study-level covariables by combining ideas from MTC and meta-regression. We use a case study from rheumatoid arthritis. We identified relevant trials of biologic verses standard therapy or placebo and extracted the doses, comparators and patient baseline characteristics. Efficacy is measured using the log odds ratio of achieving six-month ACR50 responder status. A random-effects meta-regression model is fitted which adjusts the log odds ratio for study-level prognostic factors. A different random-effect distribution on the log odds ratios is allowed for each different treatment. The odds ratio is found as a function of the prognostic factors for each treatment. The apparent differences in the randomized trials between tumour necrosis factor alpha (TNF- alpha) antagonists are explained by differences in prognostic factors and the analysis suggests that these drugs as a class are not different from each other. Copyright (c) 2006 John Wiley & Sons, Ltd.

  8. Do mobile family planning clinics facilitate vasectomy use in Nepal?

    PubMed

    Padmadas, Sabu S; Amoako Johnson, Fiifi; Leone, Tiziana; Dahal, Govinda P

    2014-06-01

    Nepal has a distinct topography that makes reproductive health and family planning services difficult to access, particularly in remote mountain and hill regions where over a quarter of modern contraceptive users rely exclusively on vasectomy. A three-level random intercept logistic regression analysis was applied on data from the 2011 Nepal Demographic and Health Survey to investigate the extent of influence of mobile family planning clinics on the odds of a male or a female sterilization, adjusting for relevant characteristics including ecological differences and random effects. The analyses included a sample of 2014 sterilization users, considering responses from currently married women of reproductive ages. The odds of a male sterilization were significantly higher in a mobile clinic than those in a government hospital (odds ratio, 1.65; 95% confidence interval, 1.21-2.25). The effects remained unaltered and statistically significant after adjusting for sociodemographic and clustering effects. Random effects were highly significant, which suggest the extent of heterogeneity in vasectomy use at the community and district levels. The odds of vasectomy use in mobile clinics were significantly higher among couples residing in hill and mountain regions and among those with three or more sons or those with only daughters. Mobile clinics significantly increase the uptake of vasectomy in hard-to-reach areas of Nepal. Reproductive health interventions should consider mobile clinics as an effective strategy to improve access to male-based modern methods and enhance gender equity in family planning. Family planning interventions in hard-to-reach communities could consider mobile clinic as an effective strategy to promote male-based modern methods. Improving access to vasectomy could substantially reduce unmet need for family planning in countries experiencing rapid fertility transition. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Effect of fermented milk-based probiotic preparations on Helicobacter pylori eradication: a systematic review and meta-analysis of randomized-controlled trials.

    PubMed

    Sachdeva, Aarti; Nagpal, Jitender

    2009-01-01

    To evaluate the effect of fermented milk-based probiotic preparations on Helicobacter pylori eradication. Systematic review of randomized controlled trials. Electronic databases and hand search of reviews, bibliographies of books and abstracts and proceedings of international conferences. Included trials had to be randomized or quasi-randomized and controlled, using fermented milk-based probiotics in the intervention group, treating Helicobacter-infected patients and evaluating improvement or eradication of H. pylori as an outcome. The search identified 10 eligible randomized controlled trials. Data were available for 963 patients, of whom 498 were in the treatment group and 465 in the control group. The pooled odds ratio (studies n=9) for eradication by intention-to-treat analysis in the treatment versus control group was 1.91 (1.38-2.67; P<0.0001) using the fixed effects model; test for heterogeneity (Cochran's Q=5.44; P=0.488). The pooled risk difference was 0.10 (95% CI 0.05-0.15; P<0.0001) by the fixed effects model (Cochran's Q=13.41; P=0.144). The pooled odds ratio for the number of patients with any adverse effect was 0.51 (95% CI 0.10-2.57; P=0.41; random effects model; heterogeneity by Cochran's Q=68.5; P<0.0001). Fermented milk-based probiotic preparations improve H. pylori eradication rates by approximately 5-15%, whereas the effect on adverse effects is heterogeneous.

  10. Does oppositional defiant disorder have temperament and psychopathological profiles independent of attention deficit/hyperactivity disorder?

    PubMed

    Kim, Hyo-Won; Cho, Soo-Churl; Kim, Boong-Nyun; Kim, Jae-Won; Shin, Min-Sup; Yeo, Jin-Young

    2010-01-01

    Most studies on temperamental and behavioral/emotional characteristics of oppositional defiant disorder (ODD) did not rule out the effect of comorbid attention-deficit/hyperactivity disorder (ADHD). The main objective of this study was to identify the temperamental and psychopathological patterns of ODD independent of comorbid ADHD. We also aimed to compare the patterns of temperament and psychopathology between ODD with and without ADHD. Parents of 2673 students, randomly selected from 19 representative schools in Seoul, Korea, completed the Diagnostic Interview Schedule for Children Version IV. Among 118 children and adolescents with ODD diagnosed by the Diagnostic Interview Schedule for Children Version IV, the parents of 94 subjects (mean age, 10.4 +/- 3.0 years) and the parents of a random sample of 94 age- and gender-matched non-ODD/non-ADHD children and adolescents completed the parent's version of the Child Behavior Checklist (CBCL) and the Junior Temperament and Character Inventory. Subjects with ODD showed temperament and character profiles of high Novelty Seeking, low Self-directedness, and low Cooperativeness, a distinct pattern on the CBCL, and were at increased risk for anxiety and mood disorders compared to the controls after controlling for the effect of comorbid ADHD. The children and adolescents with both ODD and ADHD showed decreased levels of Persistence and Self-directedness and higher scores on 4 subscales of the CBCL (Anxious/Depressed, Attention Problems, Delinquent Behaviors, and Aggressive Behaviors) compared to those with ODD only. Oppositional defiant disorder is associated with specific temperamental and behavioral/emotional characteristics, independent of ADHD. Moreover, the results of this study support that co-occurring ADHD and ODD have differentially higher levels of behavioral and emotional difficulties. Copyright 2010 Elsevier Inc. All rights reserved.

  11. Effects of nitrates on mortality in acute myocardial infarction and in heart failure

    PubMed Central

    Held, P.

    1992-01-01

    1 Seven randomized controlled trials of intravenous nitroglycerin in a total of about 850 patients have been reported. Overall, there were 51 deaths (12.5%) in the nitroglycerin group and 87 (20%) in the control group. This indicates a 48% reduction in the odds of death (P < 0.001, 95% confidence limits (25% to 64%)). 2 There are five randomized trials of oral nitrates after acute myocardial infarction. In these trials, 11.8% of the patients in the nitrate group compared with 13.3% in the control group died. This indicates a nonsignificant 12% reduction in the odds of death but the 95% confidence interval overlaps widely with the i.v. trials. If all trials of i.v. or oral nitrates are considered the reduction in the odds of death is 32% (P < 0.01). 3 Nitrates have a beneficial effect on haemodynamics in heart failure but the data on mortality effects are sparse. In combination with hydralazine, however, long-term mortality was reduced in the V-HEFT trial of chronic heart failure. PMID:1633075

  12. What affects response rates in primary healthcare-based programmes? An analysis of individual and unit-related factors associated with increased odds of non-response based on HCV screening in the general population in Poland

    PubMed Central

    Parda, Natalia; Stępień, Małgorzata; Zakrzewska, Karolina; Madaliński, Kazimierz; Kołakowska, Agnieszka; Godzik, Paulina; Rosińska, Magdalena

    2016-01-01

    Objectives Response rate in public health programmes may be a limiting factor. It is important to first consider their delivery and acceptability for the target. This study aimed at determining individual and unit-related factors associated with increased odds of non-response based on hepatitis C virus screening in primary healthcare. Design Primary healthcare units (PHCUs) were extracted from the Register of Health Care Centres. Each of the PHCUs was to enrol adult patients selected on a random basis. Data on the recruitment of PHCUs and patients were analysed. Multilevel modelling was applied to investigate individual and unit-related factors associated with non-response. Multilevel logistic model was developed with fixed effects and only a random intercept for the unit. Preliminary analysis included a random effect for unit and each of the individual or PHCU covariates separately. For each of the PHCU covariates, we applied a two-level model with individual covariates, unit random effect and a single fixed effect of this unit covariate. Setting This study was conducted in primary care units in selected provinces in Poland. Participants A total of 242 PHCUs and 24 480 adults were invited. Of them, 44 PHCUs and 20 939 patients agreed to participate. Both PHCUs and patients were randomly selected. Results Data on 44 PHCUs and 24 480 patients were analysed. PHCU-level factors and recruitment strategies were important predictors of non-response. Unit random effect was significant in all models. Larger and private units reported higher non-response rates, while for those with a history of running public health programmes the odds of non-response was lower. Proactive recruitment, more working hours devoted to the project and patient resulted in higher acceptance of the project. Higher number of personnel had no such effect. Conclusions Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. PMID:27927665

  13. What affects response rates in primary healthcare-based programmes? An analysis of individual and unit-related factors associated with increased odds of non-response based on HCV screening in the general population in Poland.

    PubMed

    Parda, Natalia; Stępień, Małgorzata; Zakrzewska, Karolina; Madaliński, Kazimierz; Kołakowska, Agnieszka; Godzik, Paulina; Rosińska, Magdalena

    2016-12-07

    Response rate in public health programmes may be a limiting factor. It is important to first consider their delivery and acceptability for the target. This study aimed at determining individual and unit-related factors associated with increased odds of non-response based on hepatitis C virus screening in primary healthcare. Primary healthcare units (PHCUs) were extracted from the Register of Health Care Centres. Each of the PHCUs was to enrol adult patients selected on a random basis. Data on the recruitment of PHCUs and patients were analysed. Multilevel modelling was applied to investigate individual and unit-related factors associated with non-response. Multilevel logistic model was developed with fixed effects and only a random intercept for the unit. Preliminary analysis included a random effect for unit and each of the individual or PHCU covariates separately. For each of the PHCU covariates, we applied a two-level model with individual covariates, unit random effect and a single fixed effect of this unit covariate. This study was conducted in primary care units in selected provinces in Poland. A total of 242 PHCUs and 24 480 adults were invited. Of them, 44 PHCUs and 20 939 patients agreed to participate. Both PHCUs and patients were randomly selected. Data on 44 PHCUs and 24 480 patients were analysed. PHCU-level factors and recruitment strategies were important predictors of non-response. Unit random effect was significant in all models. Larger and private units reported higher non-response rates, while for those with a history of running public health programmes the odds of non-response was lower. Proactive recruitment, more working hours devoted to the project and patient resulted in higher acceptance of the project. Higher number of personnel had no such effect. Prior to the implementation of public health programme, several factors that could hinder its execution should be addressed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis.

    PubMed

    Thakkar, Jay; Kurup, Rahul; Laba, Tracey-Lea; Santo, Karla; Thiagalingam, Aravinda; Rodgers, Anthony; Woodward, Mark; Redfern, Julie; Chow, Clara K

    2016-03-01

    Adherence to long-term therapies in chronic disease is poor. Traditional interventions to improve adherence are complex and not widely effective. Mobile telephone text messaging may be a scalable means to support medication adherence. To conduct a meta-analysis of randomized clinical trials to assess the effect of mobile telephone text messaging on medication adherence in chronic disease. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL (from database inception to January 15, 2015), as well as reference lists of the articles identified. The data were analyzed in March 2015. Randomized clinical trials evaluating a mobile telephone text message intervention to promote medication adherence in adults with chronic disease. Two authors independently extracted information on study characteristics, text message characteristics, and outcome measures as per the predefined protocol. Odds ratios and pooled data were calculated using random-effects models. Risk of bias and study quality were assessed as per Cochrane guidelines. Disagreement was resolved by consensus. Sixteen randomized clinical trials were included, with 5 of 16 using personalization, 8 of 16 using 2-way communication, and 8 of 16 using a daily text message frequency. The median intervention duration was 12 weeks, and self-report was the most commonly used method to assess medication adherence. In the pooled analysis of 2742 patients (median age, 39 years and 50.3% [1380 of 2742] female), text messaging significantly improved medication adherence (odds ratio, 2.11; 95% CI, 1.52-2.93; P < .001). The effect was not sensitive to study characteristics (intervention duration or type of disease) or text message characteristics (personalization, 2-way communication, or daily text message frequency). In a sensitivity analysis, our findings remained robust to change in inclusion criteria based on study quality (odds ratio, 1.67; 95% CI, 1.21-2.29; P = .002). There was moderate heterogeneity (I2 = 62%) across clinical trials. After adjustment for publication bias, the point estimate was reduced but remained positive for an intervention effect (odds ratio, 1.68; 95% CI, 1.18-2.39). Mobile phone text messaging approximately doubles the odds of medication adherence. This increase translates into adherence rates improving from 50% (assuming this baseline rate in patients with chronic disease) to 67.8%, or an absolute increase of 17.8%. While promising, these results should be interpreted with caution given the short duration of trials and reliance on self-reported medication adherence measures. Future studies need to determine the features of text message interventions that improve success, as well as appropriate patient populations, sustained effects, and influences on clinical outcomes.

  15. Effect of expanding medicaid for parents on children's health insurance coverage: lessons from the Oregon experiment.

    PubMed

    DeVoe, Jennifer E; Marino, Miguel; Angier, Heather; O'Malley, Jean P; Crawford, Courtney; Nelson, Christine; Tillotson, Carrie J; Bailey, Steffani R; Gallia, Charles; Gold, Rachel

    2015-01-01

    In the United States, health insurance is not universal. Observational studies show an association between uninsured parents and children. This association persisted even after expansions in child-only public health insurance. Oregon's randomized Medicaid expansion for adults, known as the Oregon Experiment, created a rare opportunity to assess causality between parent and child coverage. To estimate the effect on a child's health insurance coverage status when (1) a parent randomly gains access to health insurance and (2) a parent obtains coverage. Oregon Experiment randomized natural experiment assessing the results of Oregon's 2008 Medicaid expansion. We used generalized estimating equation models to examine the longitudinal effect of a parent randomly selected to apply for Medicaid on their child's Medicaid or Children's Health Insurance Program (CHIP) coverage (intent-to-treat analyses). We used per-protocol analyses to understand the impact on children's coverage when a parent was randomly selected to apply for and obtained Medicaid. Participants included 14409 children aged 2 to 18 years whose parents participated in the Oregon Experiment. For intent-to-treat analyses, the date a parent was selected to apply for Medicaid was considered the date the child was exposed to the intervention. In per-protocol analyses, exposure was defined as whether a selected parent obtained Medicaid. Children's Medicaid or CHIP coverage, assessed monthly and in 6-month intervals relative to their parent's selection date. In the immediate period after selection, children whose parents were selected to apply significantly increased from 3830 (61.4%) to 4152 (66.6%) compared with a nonsignificant change from 5049 (61.8%) to 5044 (61.7%) for children whose parents were not selected to apply. Children whose parents were randomly selected to apply for Medicaid had 18% higher odds of being covered in the first 6 months after parent's selection compared with children whose parents were not selected (adjusted odds ratio [AOR]=1.18; 95% CI, 1.10-1.27). The effect remained significant during months 7 to 12 (AOR=1.11; 95% CI, 1.03-1.19); months 13 to 18 showed a positive but not significant effect (AOR=1.07; 95% CI, 0.99-1.14). Children whose parents were selected and obtained coverage had more than double the odds of having coverage compared with children whose parents were not selected and did not gain coverage (AOR=2.37; 95% CI, 2.14-2.64). Children's odds of having Medicaid or CHIP coverage increased when their parents were randomly selected to apply for Medicaid. Children whose parents were selected and subsequently obtained coverage benefited most. This study demonstrates a causal link between parents' access to Medicaid coverage and their children's coverage.

  16. Evaluating the Sustained Health Impact of Household Chlorination of Drinking Water in Rural Haiti

    PubMed Central

    Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

    2012-01-01

    The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21–0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy. PMID:22987657

  17. Evaluating the sustained health impact of household chlorination of drinking water in rural Haiti.

    PubMed

    Harshfield, Eric; Lantagne, Daniele; Turbes, Anna; Null, Clair

    2012-11-01

    The Jolivert Safe Water for Families program has sold sodium hypochlorite solution (chlorine) and conducted household visits in rural Haiti since 2002. To assess the impact of the program on diarrheal disease, in 2010 we conducted a survey and water quality testing in 201 program participants and 425 control households selected at random. Fifty-six percent of participants (versus 10% of controls) had free chlorine residuals between 0.2 and 2.0 mg/L, indicating correct water treatment. Using intention-to-treat analysis, we found that significantly fewer children < 5 in participant households had an episode of diarrhea in the previous 48 hours (32% versus 52%; P < 0.001) with 59% reduced odds (odds ratio = 0.41, 95% confidence interval = 0.21-0.79). Treatment-on-treated estimates of the odds of diarrhea indicated larger program effects for participants who met more stringent verifications of participation. Diarrheal disease reduction in this long-term program was comparable with that seen in short-term randomized, controlled interventions, suggesting that household chlorination can be an effective long-term water treatment strategy.

  18. Neither fixed nor random: weighted least squares meta-analysis.

    PubMed

    Stanley, T D; Doucouliagos, Hristos

    2015-06-15

    This study challenges two core conventional meta-analysis methods: fixed effect and random effects. We show how and explain why an unrestricted weighted least squares estimator is superior to conventional random-effects meta-analysis when there is publication (or small-sample) bias and better than a fixed-effect weighted average if there is heterogeneity. Statistical theory and simulations of effect sizes, log odds ratios and regression coefficients demonstrate that this unrestricted weighted least squares estimator provides satisfactory estimates and confidence intervals that are comparable to random effects when there is no publication (or small-sample) bias and identical to fixed-effect meta-analysis when there is no heterogeneity. When there is publication selection bias, the unrestricted weighted least squares approach dominates random effects; when there is excess heterogeneity, it is clearly superior to fixed-effect meta-analysis. In practical applications, an unrestricted weighted least squares weighted average will often provide superior estimates to both conventional fixed and random effects. Copyright © 2015 John Wiley & Sons, Ltd.

  19. Increasing response rates to follow-up questionnaires in health intervention research: Randomized controlled trial of a gift card prize incentive.

    PubMed

    Morgan, Amy J; Rapee, Ronald M; Bayer, Jordana K

    2017-08-01

    Background/aims Achieving a high response rate to follow-up questionnaires in randomized controlled trials of interventions is important for study validity. Few studies have tested the value of incentives in increasing response rates to online questionnaires in clinical trials of health interventions. This study evaluated the effect of a gift card prize-draw incentive on response rates to follow-up questionnaires within a trial of an online health intervention. Method The study was embedded in a host randomized controlled trial of an online parenting program for child anxiety. A total of 433 participants were randomly allocated to one of two groups: (1) being informed that they would enter a gift card prize-draw if they completed the final study questionnaire (24-week follow-up) and (2) not informed about the prize-draw. All participants had a 1 in 20 chance of winning an AUD50 gift card after they completed the online questionnaire. Results The odds of the informed group completing the follow-up questionnaire were significantly higher than the uninformed group, (79.6% vs 68.5%, odds ratio = 1.79, 95% confidence interval = 1.15-2.79). This response rate increase of 11.1% (95% confidence interval = 2.8-19.1) occurred in both intervention and control groups in the host randomized controlled trial. The incentive was also effective in increasing questionnaire commencement (84.6% vs 75.9%, odds ratio = 1.74, 95% confidence interval = 1.07-2.84) and reducing the delay in completing the questionnaire (19.9 vs 22.6 days, hazard ratio = 1.34, 95% confidence interval = 1.07-1.67). Conclusion This study adds to evidence for the effectiveness of incentives to increase response rates to follow-up questionnaires in health intervention trials.

  20. Dirty two-band superconductivity with interband pairing order

    NASA Astrophysics Data System (ADS)

    Asano, Yasuhiro; Sasaki, Akihiro; Golubov, Alexander A.

    2018-04-01

    We study theoretically the effects of random nonmagnetic impurities on the superconducting transition temperature T c in a two-band superconductor characterized by an equal-time s-wave interband pairing order parameter. Because of the two-band degree of freedom, it is possible to define a spin-triplet s-wave pairing order parameter as well as a spin-singlet s-wave order parameter. The former belongs to odd-band-parity symmetry class, whereas the latter belongs to even-band-parity symmetry class. In a spin-singlet superconductor, T c is insensitive to the impurity concentration when we estimate the self-energy due to the random impurity potential within the Born approximation. On the other hand in a spin-triplet superconductor, T c decreases with the increase of the impurity concentration. We conclude that Cooper pairs belonging to odd-band-parity symmetry class are fragile under the random impurity potential even though they have s-wave pairing symmetry.

  1. Combined metformin-clomiphene in clomiphene-resistant polycystic ovary syndrome: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Abu Hashim, Hatem; Foda, Osama; Ghayaty, Essam

    2015-09-01

    Our objective was to compare the effectiveness of metformin plus clomiphene citrate vs. gonadotrophins, laparoscopic ovarian diathermy, aromatase inhibitors, N-acetyl-cysteine and other insulin sensitizers+clomiphene for improving fertility outcomes in women with clomiphene-resistant polycystic ovary syndrome. PubMed, SCOPUS and CENTRAL databases were searched until April 2014 with the key words: PCOS, polycystic ovary syndrome, metformin, clomiphene citrate, ovulation induction and pregnancy. The search was limited to articles conducted with humans and published in English. The PRISMA statement was followed. Twelve randomized controlled trials (n = 1411 women) were included. Ovulation and clinical pregnancy rates per woman randomized. Compared with gonadotrophins, the metformin+clomiphene combination resulted in significantly fewer ovulations (odds ratio 0.25; 95% confidence interval 0.15-0.41; p < 0.00001, 3 trials, I(2) = 85%, n = 323) and pregnancies (odds ratio 0.45; 95% confidence interval 0.27-0.75; p = 0.002, 3 trials, I(2) = 0%, n = 323). No significant differences were found when metformin+clomiphene was compared with laparoscopic ovarian diathermy (odds ratio 0.88; 95% confidence interval 0.53-1.47; p = 0.62, 1 trial, n = 282; odds ratio 0.96; 95% confidence interval 0.60-1.54; p = 0.88, 2 trials, I(2) = 0%, n = 332, for ovulation and pregnancy rates, respectively). Likewise, no differences were observed in comparison with aromatase inhibitors (odds ratio 0.88; 95% confidence interval 0.58-1.34; p = 0.55, 3 trials, I(2) = 3%, n = 409; odds ratio 0.85; 95% confidence interval 0.53-1.36; p = 0.50, 2 trials, n = 309, for ovulation and pregnancy rates, respectively). There is evidence for the superiority of gonadotrophins, but the metformin+clomiphene combination is mainly relevant for clomiphene-resistant polycystic ovary syndrome patients and, if not effective, a next step could be gonadotrophins. More attempts with metformin+clomiphene are only relevant if there is limited access to gonadotrophins. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  2. Yo Puedo--a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in san francisco.

    PubMed

    Minnis, Alexandra M; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S

    2014-07-01

    We designed and evaluated for feasibility an intervention-Yo Puedo-that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing. Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions, and targeted youth 16-21 years of age and same-aged members of their social network. We conducted a two-arm study with social networks randomized to the intervention or a standard services control arm. We evaluated intervention uptake, adherence, and safety; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and sexually transmitted infection risk. A total of 72 social networks composed of 162 youth enrolled, with 92% retention over 6 months. Seventy-two percent of youth randomized to the intervention participated in intervention activities: 53% received at least one conditional cash transfer payment and 66% came to at least one life skills session. We found no evidence that cash payments financed illicit or high-risk behavior. At 6 months, compared with controls, intervention participants had a lower odds of hanging out on the street frequently (odds ratio [OR], .54; p = .10) and a lower odds of reporting that their close friends had been incarcerated (OR, .6; p = .12). They reported less regular alcohol use (OR, .54; p = .04) and a lower odds of having sex (OR, .50; p = .04). The feasibility evaluation of Yo Puedo demonstrated its promise; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  3. The effect of adding Coping Power Program-Sweden to Parent Management Training-effects and moderators in a randomized controlled trial.

    PubMed

    Helander, Maria; Lochman, John; Högström, Jens; Ljótsson, Brjánn; Hellner, Clara; Enebrink, Pia

    2018-04-01

    For children with oppositional defiant disorder (ODD), Parent Management Training (PMT) is a recommended treatment in addition to child Cognitive Behavioral Therapy (child-CBT). There is however a lack of studies investigating the additive effect of group-based child-CBT to PMT for children between 8 and 12 years. The current study investigated the incremental effect of group-based child-CBT, based on the Coping Power Program, when added to the Swedish group-based PMT program KOMET. Outcomes were child behavior problems, child prosocial behavior, parenting skills and the moderating effect of child characteristics. One hundred and twenty children 8-12 years with ODD or Disruptive Behavioral Disorder NOS and their parents were randomized either to combined child-CBT and PMT (n = 63) or to PMT only (n = 57) in Swedish Child- and Adolescent Psychiatric settings. Participants were assessed pre- and post-treatment using semi-structured interviews and child- and parent ratings. After treatment, behavior problems were reduced in both groups. Prosocial behavior were significantly more improved in the combined treatment. Parenting skills were improved in both groups. In moderator analyses, behavior problems and prosocial behavior improved significantly more in the combined treatment compared to PMT only in the group of children with high levels of ODD symptoms. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Effect of Expanding Medicaid for Parents on Children’s Health Insurance Coverage

    PubMed Central

    DeVoe, Jennifer E.; Marino, Miguel; Angier, Heather; O’Malley, Jean P.; Crawford, Courtney; Nelson, Christine; Tillotson, Carrie J.; Bailey, Steffani R.; Gallia, Charles; Gold, Rachel

    2016-01-01

    IMPORTANCE In the United States, health insurance is not universal. Observational studies show an association between uninsured parents and children. This association persisted even after expansions in child-only public health insurance. Oregon’s randomized Medicaid expansion for adults, known as the Oregon Experiment, created a rare opportunity to assess causality between parent and child coverage. OBJECTIVE To estimate the effect on a child’s health insurance coverage status when (1) a parent randomly gains access to health insurance and (2) a parent obtains coverage. DESIGN, SETTING, AND PARTICIPANTS Oregon Experiment randomized natural experiment assessing the results of Oregon’s 2008 Medicaid expansion. We used generalized estimating equation models to examine the longitudinal effect of a parent randomly selected to apply for Medicaid on their child’s Medicaid or Children’s Health Insurance Program (CHIP) coverage (intent-to-treat analyses). We used per-protocol analyses to understand the impact on children’s coverage when a parent was randomly selected to apply for and obtained Medicaid. Participants included 14 409 children aged 2 to 18 years whose parents participated in the Oregon Experiment. EXPOSURES For intent-to-treat analyses, the date a parent was selected to apply for Medicaid was considered the date the child was exposed to the intervention. In per-protocol analyses, exposure was defined as whether a selected parent obtained Medicaid. MAIN OUTCOMES AND MEASURES Children’s Medicaid or CHIP coverage, assessed monthly and in 6-month intervals relative to their parent’s selection date. RESULTS In the immediate period after selection, children whose parents were selected to apply significantly increased from 3830 (61.4%) to 4152 (66.6%) compared with a nonsignificant change from 5049 (61.8%) to 5044 (61.7%) for children whose parents were not selected to apply. Children whose parents were randomly selected to apply for Medicaid had 18% higher odds of being covered in the first 6 months after parent’s selection compared with children whose parents were not selected (adjusted odds ratio [AOR] = 1.18; 95% CI, 1.10–1.27). The effect remained significant during months 7 to 12 (AOR = 1.11; 95% CI, 1.03–1.19); months 13 to 18 showed a positive but not significant effect (AOR = 1.07; 95% CI, 0.99–1.14). Children whose parents were selected and obtained coverage had more than double the odds of having coverage compared with children whose parents were not selected and did not gain coverage (AOR = 2.37; 95% CI, 2.14–2.64). CONCLUSIONS AND RELEVANCE Children’s odds of having Medicaid or CHIP coverage increased when their parents were randomly selected to apply for Medicaid. Children whose parents were selected and subsequently obtained coverage benefited most. This study demonstrates a causal link between parents’ access to Medicaid coverage and their children’s coverage. PMID:25561041

  5. Effectiveness of peer-led education on knowledge, attitude and risk behavior practices related to HIV among students at a Malaysian public university--a randomized controlled trial.

    PubMed

    Ibrahim, Normala; Rampal, Lekhraj; Jamil, Zubaidah; Zain, Azhar Mohd

    2012-11-01

    Develop, implement and evaluate the effectiveness of a peer-led education program related to HIV/AIDS among university students. randomized controlled trial with 276 university students at Faculty of Medicine and Health Sciences University Putra Malaysia (UPM), Serdang in 2011. A peer-led education program on HIV prevention by university students. differences in knowledge, attitude and risk behavior practices related to HIV between baselines, immediate follow-up after intervention and after three months. Significant improvement in sound knowledge in the intervention group as compared to the control group (Odds ratio, 1.75; 95% CI 1.01, 3.00; p=0.04) and improvement in good attitude related to HIV (Odds ratio 2.22; 95% CI 1.37, 3.61; p=0.01). The odds of high substance risk behavior was significantly reduced in the intervention group as compared to the control group (Odds ratio 0.07; 95% CI 0.02, 0.34; p=0.01). The association between good knowledge and intervention was modified by the different time points (baseline, immediately after intervention and 3 months after intervention), ethnicity and gender. Peer-led education program in HIV prevention improves knowledge, attitude and substance risk behavior. Changes in sexual risk behavior may require a longer follow-up. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. Pearson's random walk in the space of the CMB phases: Evidence for parity asymmetry

    NASA Astrophysics Data System (ADS)

    Hansen, M.; Frejsel, A. M.; Kim, J.; Naselsky, P.; Nesti, F.

    2011-05-01

    The temperature fluctuations of the cosmic microwave background (CMB) are supposed to be distributed randomly in both magnitude and phase, following to the simplest model of inflation. In this paper, we look at the odd and even multipoles of the spherical harmonic decomposition of the CMB, and the different characteristics of these, giving rise to a parity asymmetry. We compare the even and odd multipoles in the CMB power spectrum, and also the even and odd mean angles. We find for the multipoles of the power spectrum that there is power excess in odd multipoles, compared to even ones, meaning that we have a parity asymmetry. Further, for the phases, we present a random walk for the mean angles, and find a significant separation for even/odd mean angles, especially so for galactic coordinates. This is further tested and confirmed with a directional parity test, comparing the parity asymmetry in galactic and ecliptic coordinates.

  7. Efficacy of a Clinic-Based Safer Sex Program for Human Immunodeficiency Virus-Uninfected and Human Immunodeficiency Virus-Infected Young Black Men Who Have Sex With Men: A Randomized Controlled Trial.

    PubMed

    Crosby, Richard A; Mena, Leandro; Salazar, Laura F; Hardin, James W; Brown, Tim; Vickers Smith, Rachel

    2018-03-01

    To test the efficacy of a single-session, clinic-based intervention designed to promote condom use among young black men who have sex with men (YBMSM). Six hundred YBMSM were enrolled in a randomized controlled trial, using a 12-month observation period. An intent-to-treat analysis was performed, with multiple imputation for missing data. Compared with the reference group, human immunodeficiency virus (HIV)-infected men in the intervention group had 64% greater odds of reporting consistent condom use for anal receptive sex over 12 months (estimated odds ratio, 1.64; 95% confidence interval, 1.23-2.17, P = 0.001). Also, compared with the reference group, HIV-uninfected men in the intervention group had more than twice the odds of reporting consistent condom use for anal receptive sex over 12 months (estimated odds ratio, 2.14; 95% confidence interval, 1.74-2.63, P < 0.001). Significant intervention effects relative to incident sexually transmitted diseases were not observed. A single-session, clinic-based, intervention may help protect HIV-uninfected YBMSM against HIV acquisition and HIV-infected YBMSM from transmitting the virus to insertive partners.

  8. The relationship of race to women's use of health information resources.

    PubMed

    Nicholson, Wanda K; Grason, Holly A; Powe, Neil R

    2003-02-01

    The purpose of this study was to examine, among the general public, the independent effect of race on women's use of health information resources. A population-based random-digit dialing survey of adult women, aged 18 to 64 years, was conducted between October 1999 and January 2000. Subjects included 509 women (341 white women, 135 black women, and 33 women of other races). The response rate was 66%. The main outcome variable was the use of health information resources (print health or news media, broadcast media, computer resources [Internet], health organizations, organized health events). Logistic regression was used to determine the independent effect of race/ethnicity on the use of different information resources, with an adjustment for age, income, education, and marital status. After the adjustment for socioeconomic factors, black women had <50% odds of using print news media (odds ratio, 0.5; 95% CI, 0.4-0.8), <60% odds of using computer-based resources (odds ratio, 0.4; 95% CI, 0.2-0.6), and <70% odds of using health policy organizations (odds ratio, 0.3; 95% CI, 0.2-0.7), compared with white women. There is a large racial disparity in women's use of health information resources. Traditional sources that are used to provide patient information may not be effective in certain populations.

  9. The role of behavioral economic incentive design and demographic characteristics in financial incentive-based approaches to changing health behaviors: a meta-analysis.

    PubMed

    Haff, Nancy; Patel, Mitesh S; Lim, Raymond; Zhu, Jingsan; Troxel, Andrea B; Asch, David A; Volpp, Kevin G

    2015-01-01

    To evaluate the use of behavioral economics to design financial incentives to promote health behavior change and to explore associations with demographic characteristics. Studies performed by the Center for Health Incentives and Behavioral Economics at the University of Pennsylvania published between January 2006 and March 2014. Randomized, controlled trials with available participant-level data. Studies that did not use financial incentives to promote health behavior change were excluded. Participant-level data from seven studies were pooled. Meta-analysis on the pooled sample using a random-effects model with interaction terms to examine treatment effects and whether they varied by incentive structure or demographic characteristics. The pooled study sample comprised 1403 participants, of whom 35% were female, 70% were white, 24% were black, and the mean age was 48 years (standard deviation 11.2 years). In the fully adjusted model, participants offered financial incentives had higher odds of behavior change (odds ratio [OR]: 3.96; p < .01) when compared to control. There were no significant interactions between financial incentives and gender, age, race, income, or education. When further adjusting for incentive structure, blacks had higher odds than whites of achieving behavior change (OR: 1.67; p < .05) with a conditional payment. Compared to lower-income participants, higher-income participants had lower odds of behavior change (OR: 0.46; p = .01) with a regret lottery. Financial incentives designed using concepts from behavioral economics were effective for promoting health behavior change. There were no large and consistent relationships between the effectiveness of financial incentives and observable demographic characteristics. Second-order examinations of incentive structure suggest potential relationships among the effectiveness of financial incentives, incentive structure, and the demographic characteristics of race and income.

  10. Albumin in Burn Shock Resuscitation: A Meta-Analysis of Controlled Clinical Studies.

    PubMed

    Navickis, Roberta J; Greenhalgh, David G; Wilkes, Mahlon M

    2016-01-01

    Critical appraisal of outcomes after burn shock resuscitation with albumin has previously been restricted to small relatively old randomized trials, some with high risk of bias. Extensive recent data from nonrandomized studies assessing the use of albumin can potentially reduce bias and add precision. The objective of this meta-analysis was to determine the effect of burn shock resuscitation with albumin on mortality and morbidity in adult patients. Randomized and nonrandomized controlled clinical studies evaluating mortality and morbidity in adult patients receiving albumin for burn shock resuscitation were identified by multiple methods, including computer database searches and examination of journal contents and reference lists. Extracted data were quantitatively combined by random-effects meta-analysis. Four randomized and four nonrandomized studies with 688 total adult patients were included. Treatment effects did not differ significantly between the included randomized and nonrandomized studies. Albumin infusion during the first 24 hours showed no significant overall effect on mortality. However, significant statistical heterogeneity was present, which could be abolished by excluding two studies at high risk of bias. After those exclusions, albumin infusion was associated with reduced mortality. The pooled odds ratio was 0.34 with a 95% confidence interval of 0.19 to 0.58 (P < .001). Albumin administration was also accompanied by decreased occurrence of compartment syndrome (pooled odds ratio, 0.19; 95% confidence interval, 0.07-0.50; P < .001). This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited, and additional trials are needed.

  11. Effect of handgrip on coronary artery disease and myocardial infarction: a Mendelian randomization study.

    PubMed

    Xu, Lin; Hao, Yuan Tao

    2017-04-19

    Observational studies have reported an association of handgrip strength with risk of cardiovascular disease. However, residual confounding and reverse causation may have influenced these findings. A Mendelian randomization (MR) study was conducted to examine whether handgrip is causally associated with cardiovascular disease. Two single nucleotide polymorphisms (SNPs), rs3121278 and rs752045, were used as the genetic instruments for handgrip. The effect of each SNP on coronary artery disease/myocardial infarction (CAD/MI) was weighted by its effect on handgrip strength, and estimates were pooled to provide a summary measure for the effect of increased handgrip on risk of CAD/MI. MR analysis showed that higher grip strength reduces risk for CAD/MI, with 1-kilogram increase in genetically determined handgrip reduced odds of CAD by 6% (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.91-0.99, P = 0.01), and reduced odds of MI by 7% (OR = 0.93, 95% CI 0.89-0.98, P = 0.003). No association of grip strength with type 2 diabetes, body mass index, LDL- and HDL-cholesterol, triglycerides and fasting glucose was found. The inverse causal relationship between handgrip and the risk of CAD or MI suggests that promoting physical activity and resistance training to improve muscle strength may be important for cardiovascular health.

  12. Efficacy and safety of granulocyte and monocyte adsorption apheresis for ulcerative colitis: a meta-analysis.

    PubMed

    Yoshino, Takuya; Nakase, Hiroshi; Minami, Naoki; Yamada, Satoshi; Matsuura, Minoru; Yazumi, Shujiro; Chiba, Tsutomu

    2014-03-01

    Safe and effective treatments are required for patients with ulcerative colitis. It was suggested that granulocyte and monocyte adsorption apheresis might play an important role for ulcerative colitis. Therefore, a meta-analysis was performed. Medline and the Cochrane controlled trials register were used to identify randomized controlled trials comparing granulocyte and monocyte adsorption apheresis with corticosteroids, and comparing intensive with conventional apheresis in patients with ulcerative colitis. Nine randomized trials were eligible for inclusion criteria. According to pooled data, granulocyte and monocyte adsorption apheresis is effective for inducing clinical remission in patients with ulcerative colitis compared with corticosteroids (odds ratio, 2.23; 95% confidence interval: 1.38-3.60). However, the efficacy of granulocyte and monocyte adsorption apheresis was not dependent on the number of apheresis sessions. The intensive apheresis (≥2 sessions per week) is more effective for inducing clinical remission than weekly apheresis (odds ratio, 2.10; 95% confidence interval: 1.12-3.93). The rate of adverse events by apheresis was significantly lower than that by corticosteroids (odds ratio, 0.24; 95% confidence interval: 0.15-0.37). Our meta-analysis reveals that intensive granulocyte and monocyte adsorption apheresis is a safe and effective treatment with higher rates of clinical remission and response for ulcerative colitis compared with corticosteroids. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  13. Evaluation of the effectiveness of laser in situ keratomileusis and photorefractive keratectomy for myopia: a meta-analysis.

    PubMed

    Yang, Xin-Jun; Yan, Hong-Tao; Nakahori, Yutaka

    2003-08-01

    To evaluate the effectiveness of laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) for correcting myopia. Study selection, data extraction, and quality assessment were performed by two of authors independently. Summary odds ratios and 95% confidence intervals were calculated by DerSimonian & Laird random-effects model and Mantel-Haenszel (fixed-effects) model. All calculations were based on an intention-to-treat and per protocol analysis. Five hundred and eighty eyes (476 patients) from 5 randomized controlled trials were included in this study. At > or = 6 months follow-up, by random-effects model, the pooled odds ratios (OR, for LASIK vs. PRK) of postoperative uncorrected visual acuity (UCVA) of 20/20 or better for all trials were 1.31 (95% CI=0.77-2.22) by per protocol analysis and 1.18 (95% CI=0.74-1.88) by intention-to-treat analysis. In the refractive outcome, the pooled OR of the postoperative spherical equivalent refraction within +/-0.5 diopter (D) of emmetropia did not show any statistical significance, for which the OR were 0.75 (95% CI=0.48-1.18) by per protocol analysis and 0.70 (95% CI=0.47-1.04) by intention-to-treat analysis. LASIK and PRK were found to be similarly effective for the correction of myopia from -1.5 to -15.0 D in a greater than 6 month follow-up.

  14. A Meta-Analysis of the Efficacy of Behavioral Interventions to Reduce Risky Sexual Behavior and Decrease Sexually Transmitted Infections in Latinas Living in the United States.

    PubMed

    Althoff, Meghan D; Grayson, Cary T; Witt, Lucy; Holden, Julie; Reid, Daniel; Kissinger, Patricia

    2015-12-01

    The objective of this meta-analysis was to determine the effect of behavioral interventions in reducing risky sexual behavior and incident sexually transmitted infections (STI) among Latina women living in the United States. Studies were found by systematically searching the MEDLINE, EMBASE, and PsychInfo databases without language restriction. Two independent reviewers screened abstracts and full texts of articles to find randomized control trials testing the effects of behavioral interventions aimed at changing risky sexual behavior among Latinas. Articles were selected using prespecified inclusion criteria. Two independent reviewers extracted data from the included trials in duplicate using a standardized data extraction form. Six randomized control trials met the inclusion criteria for a total of 2,909 participants. Using random effects models with inverse variance weighting, we found a protective effect of the behavioral intervention on reported risky sexual behavior (odds ratio = 0.52; 95% confidence interval = 0.42, 0.64) and on incident nonviral STI (odds ratio = 0.65; 95% confidence interval = 0.46, 0.93). Behavioral interventions targeted toward Latina populations are effective in reducing risky sexual behaviors and incident STI and should be considered by policymakers as a potential tool for HIV/STI prevention in this population. © 2014 Society for Public Health Education.

  15. Prognostic value of major extracranial injury in traumatic brain injury: an individual patient data meta-analysis in 39,274 patients.

    PubMed

    van Leeuwen, Nikki; Lingsma, Hester F; Perel, Pablo; Lecky, Fiona; Roozenbeek, Bob; Lu, Juan; Shakur, Haleema; Weir, James; Steyerberg, Ewout W; Maas, Andrew I R

    2012-04-01

    Major extracranial injury (MEI) is common in traumatic brain injury (TBI) patients, but the effect on outcome is controversial. To assess the prognostic value of MEI on mortality after TBI in an individual patient data meta-analysis of 3 observational TBI studies (International Mission on Prognosis and Clinical Trial Design in TBI [IMPACT]), a randomized controlled trial (Corticosteroid Randomization After Significant Head Injury [CRASH]), and a trauma registry (Trauma Audit and Research Network [TARN]). MEI (extracranial injury with an Abbreviated Injury Scale ≥ 3 or requiring hospital admission) was related to mortality with logistic regression analysis, adjusted for age, Glasgow Coma Scale motor score, and pupil reactivity and stratified by TBI severity. We pooled odds ratios (ORs) with random-effects meta-analysis. We included 39,274 patients. Mortality was 25%, and 32% had MEI. MEI was a strong predictor for mortality in TARN, with adjusted odds ratios of 2.81 (95% confidence interval [CI], 2.44-3.23) in mild, 2.18 (95% CI, 1.80-2.65) in moderate, and 2.14 (95% CI, 1.95-2.35) in severe TBI patients. The prognostic effect was smaller in IMPACT and CRASH, with pooled adjusted odds ratios of 2.14 (95% CI, 0.93-4.91) in mild, 1.46 (95% CI, 1.14-1.85) in moderate, and 1.18 (95% CI, 1.03-1.55) in severe TBI. When patients who died within 6 hours after injury were excluded from TARN, the effect of MEI was comparable with IMPACT and CRASH. MEI is an important prognostic factor for mortality in TBI patients. However, the effect varies by population, which explains the controversy in the literature. The strength of the effect is smaller in patients with more severe brain injury and depends on time of inclusion in a study.

  16. Evaluating the Effects of Aluminum-Containing and Non-Aluminum Containing Deodorants on Axillary Skin Toxicity During Radiation Therapy for Breast Cancer: A 3-Armed Randomized Controlled Trial

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lewis, Lucy, E-mail: Lucy.lewis@curtin.edu.au; School of Nursing and Midwifery Curtin University, Perth; Carson, Sharron

    Purpose: Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity. The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer. Methods and Materials: This 3-arm randomized controlled study was conducted at a single center, tertiary cancer hospital between March 2011 and April 2013. Participants were randomized to 1 of 2 experimental groups (aluminum-containing deodorant and soap or non–aluminum containing deodorant and soap) or a control group (soap). A totalmore » of 333 participants were randomized. Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group. The study evaluated a range of endpoints including objective measurements of axilla sweating, skin toxicity, pain, itch and burning. Quality of life was assessed with a validated questionnaire. Results: Radiation characteristics were similar across all groups. Patients in the deodorant groups did not report significantly different ratings for axillary pain, itch, or burning compared with the control group. Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85% (odds ratio, 0.15; 95% confidence interval, 0.03-0.91). Conclusions: We found no evidence that the use of either aluminum-containing or non–aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer. Our analysis also suggests patients in the aluminum-containing deodorant arm had significantly less sweating without increased symptoms of axillary radiation skin toxicity. These results add to the evidence that the prescription of deodorants during radiation therapy for breast cancer is now questionable.« less

  17. Evaluating the effects of aluminum-containing and non-aluminum containing deodorants on axillary skin toxicity during radiation therapy for breast cancer: a 3-armed randomized controlled trial.

    PubMed

    Lewis, Lucy; Carson, Sharron; Bydder, Sean; Athifa, Mariyam; Williams, Anne M; Bremner, Alexandra

    2014-11-15

    Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity. The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer. This 3-arm randomized controlled study was conducted at a single center, tertiary cancer hospital between March 2011 and April 2013. Participants were randomized to 1 of 2 experimental groups (aluminum-containing deodorant and soap or non-aluminum containing deodorant and soap) or a control group (soap). A total of 333 participants were randomized. Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group. The study evaluated a range of endpoints including objective measurements of axilla sweating, skin toxicity, pain, itch and burning. Quality of life was assessed with a validated questionnaire. Radiation characteristics were similar across all groups. Patients in the deodorant groups did not report significantly different ratings for axillary pain, itch, or burning compared with the control group. Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85% (odds ratio, 0.15; 95% confidence interval, 0.03-0.91). We found no evidence that the use of either aluminum-containing or non-aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer. Our analysis also suggests patients in the aluminum-containing deodorant arm had significantly less sweating without increased symptoms of axillary radiation skin toxicity. These results add to the evidence that the prescription of deodorants during radiation therapy for breast cancer is now questionable. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. Effects of the It's Your Game . . . Keep It Real program on dating violence in ethnic-minority middle school youths: a group randomized trial.

    PubMed

    Peskin, Melissa F; Markham, Christine M; Shegog, Ross; Baumler, Elizabeth R; Addy, Robert C; Tortolero, Susan R

    2014-08-01

    We examined whether It's Your Game . . . Keep It Real (IYG) reduced dating violence among ethnic-minority middle school youths, a population at high risk for dating violence. We analyzed data from 766 predominantly ethnic-minority students from 10 middle schools in southeast Texas in 2004 for a group randomized trial of IYG. We estimated logistic regression models, and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade. Control students had significantly higher odds of physical dating violence victimization (adjusted odds ratio [AOR] = 1.52; 95% confidence interval [CI] = 1.20, 1.92), emotional dating violence victimization (AOR = 1.74; 95% CI = 1.36, 2.24), and emotional dating violence perpetration (AOR = 1.58; 95% CI = 1.11, 2.26) than did intervention students. The odds of physical dating violence perpetration were not significantly different between the 2 groups. Program effects varied by gender and race/ethnicity. IYG significantly reduced 3 of 4 dating violence outcomes among ethnic-minority middle school youths. Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence, it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior.

  19. Effects of the It’s Your Game . . . Keep It Real Program on Dating Violence in Ethnic-Minority Middle School Youths: A Group Randomized Trial

    PubMed Central

    Markham, Christine M.; Shegog, Ross; Baumler, Elizabeth R.; Addy, Robert C.; Tortolero, Susan R.

    2014-01-01

    Objectives. We examined whether It’s Your Game . . . Keep It Real (IYG) reduced dating violence among ethnic-minority middle school youths, a population at high risk for dating violence. Methods. We analyzed data from 766 predominantly ethnic-minority students from 10 middle schools in southeast Texas in 2004 for a group randomized trial of IYG. We estimated logistic regression models, and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade. Results. Control students had significantly higher odds of physical dating violence victimization (adjusted odds ratio [AOR] = 1.52; 95% confidence interval [CI] = 1.20, 1.92), emotional dating violence victimization (AOR = 1.74; 95% CI = 1.36, 2.24), and emotional dating violence perpetration (AOR = 1.58; 95% CI = 1.11, 2.26) than did intervention students. The odds of physical dating violence perpetration were not significantly different between the 2 groups. Program effects varied by gender and race/ethnicity. Conclusions. IYG significantly reduced 3 of 4 dating violence outcomes among ethnic-minority middle school youths. Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence, it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior. PMID:24922162

  20. Children with ADHD and symptoms of oppositional defiant disorder improved in behavior when treated with methylphenidate and adjuvant risperidone, though weight gain was also observed - Results from a randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Jahangard, Leila; Akbarian, Shahrokh; Haghighi, Mohammad; Ahmadpanah, Mohammad; Keshavarzi, Amir; Bajoghli, Hafez; Sadeghi Bahmani, Dena; Holsboer-Trachsler, Edith; Brand, Serge

    2017-05-01

    Children with ADHD often show symptoms of oppositional defiant disorders (ODD). We investigated the impact of adjuvant risperidone (RISP) to a standard treatment with methylphenidate (MPH) in children with ADHD and symptoms of ODD. Eighty-four children with ADHD and ODD (age: M=8.55; range: 7.28-9.95 years; 73.8% males) took part in a double-blind, randomized, placebo-controlled, clinical trial lasting eight weeks. Participants were randomly assigned either to the MPH+RISP (1mg/kg/d+0.5mg/d) or to the MPH+PLCO (1mg/kg/d+placebo) condition. Symptoms of ADHD, weight, height, and blood pressure were assessed at baseline, and at weeks 2, 4, 6 and 8. Symptoms of ADHD decreased over time, but more so in the MPH+RISP than in the MPH only condition. In the MPH+RISP condition weight, waist circumference and prolactine levels increased over time. Data suggest that adjuvant RISP improved symptoms in children with ADHD and ODD, but weight gain and higher prolactine levels were also observed, which are two alarming side effects. This may become an issue, once children become adolescents, a period of life in which body shape and body self-image are closely linked to self-confidence and peer acceptance. Health care professionals should carefully balance the short-term and long-term costs and benefits of administration of RISP. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

    PubMed

    Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

    2016-03-01

    Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p < 0.01) and depression (odds ratio, 0.29; 95% CI, 0.11-0.77; p < 0.01) in female patients after dexamethasone administration. Health-related quality of life did not differ between groups and was not associated with psychopathology. Overall, our findings suggest that exogenous administration of the glucocorticoid receptor agonist dexamethasone-compared with placebo-during cardiac surgery does not positively or negatively affect the prevalence of posttraumatic stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

  2. Determinants of Anemia and Hemoglobin Concentration in Haitian School-Aged Children

    PubMed Central

    Iannotti, Lora L.; Delnatus, Jacques R.; Odom, Audrey R.; Eaton, Jacob C.; Griggs, Jennifer J.; Brown, Sarah; Wolff, Patricia B.

    2015-01-01

    Anemia diminishes oxygen transport in the body, resulting in potentially irreversible growth and developmental consequences for children. Limited evidence for determinants of anemia exists for school-aged children. We conducted a cluster randomized controlled trial in Haiti from 2012 to 2013 to test the efficacy of a fortified school snack. Children (N = 1,047) aged 3–13 years were followed longitudinally at three time points for hemoglobin (Hb) concentrations, anthropometry, and bioelectrical impedance measures. Dietary intakes, infectious disease morbidities, and socioeconomic and demographic factors were collected at baseline and endline. Longitudinal regression modeling with generalized least squares and logit models with random effects identified anemia risk factors beyond the intervention effect. At baseline, 70.6% of children were anemic and 2.6% were severely anemic. Stunting increased the odds of developing anemia (adjusted odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.05–2.08) and severe anemia (adjusted OR: 2.47, 95% CI: 1.30–4.71). Parent-reported vitamin A supplementation and deworming were positively associated with Hb concentrations, whereas fever and poultry ownership showed a negative relationship with Hb concentration and increased odds of severe anemia, respectively. Further research should explore the full spectrum of anemia etiologies in school children, including genetic causes. PMID:26350448

  3. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada).

    PubMed

    McGrath, Patrick J; Sourander, Andre; Lingley-Pottie, Patricia; Ristkari, Terja; Cunningham, Charles; Huttunen, Jukka; Filbert, Katharine; Aromaa, Minna; Corkum, Penny; Hinkka-Yli-Salomäki, Susanna; Kinnunen, Malin; Lampi, Katja; Penttinen, Anne; Sinokki, Atte; Unruh, Anita; Vuorio, Jenni; Watters, Carolyn

    2013-10-21

    Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent-child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child's sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using parental and daycare teacher measures at 6 and 12 months after randomization. The Strongest Families Smart Website intervention is hypothesized to improve parenting skills, reduce child disruptive behaviour, reduce parental distress and improve family functioning. These results will likely inform subsequent investigations, public policy, and early treatment of childhood disruptive behaviour problems. ClinicalTrials.gov # NCT01750996.

  4. Remote population-based intervention for disruptive behavior at age four: study protocol for a randomized trial of Internet-assisted parent training (Strongest Families Finland-Canada)

    PubMed Central

    2013-01-01

    Background Oppositional Defiant Disorder (ODD) is characterized by angry and noncompliant behaviour. It is the most common disruptive behaviour disorder (DBD), with prevalence estimates of 6-9% for preschoolers and is closely linked to several long-term difficulties, including disorders of conduct, mood, anxiety, impulse-control, and substance abuse. ODD in children is related to parental depression, family dysfunction, and impairments in parental work performance. Children displaying early DBDs exhibit more symptoms of greater severity, more frequent offences, and commit more serious crimes later in life. The goal of the Strongest Families™ Finland Canada (SFFC) Smart Website intervention research program is to develop and evaluate an affordable, accessible, effective secondary prevention parent training program for disruptive behaviour in preschoolers to prevent the negative sequelae of ODD. Strongest Families is an 11-session program with two booster sessions that focuses on teaching skills to: strengthen parent–child relationships; reinforce positive behaviour; reduce conflict; manage daily transitions; plan for potentially problematic situations; promote emotional regulation and pro-social behaviour and decrease antisocial behaviour. Methods/design This protocol paper describes an ongoing population-based randomized controlled trial (RCT) of high-risk 4 year-olds attending well-child clinics in Turku, Finland and environs to examine the effectiveness of the Strongest Families Smart Website intervention compared to an Education Control condition. Randomization consists of a 1:1 ratio for intervention versus the education group, stratified by the child’s sex. The participants randomized to the intervention group receive access to the Strongest Families Smart Website and weekly telephone coaching sessions. The participants randomized to the Education Control condition receive access to a static website with parenting tips. Children are followed using parental and daycare teacher measures at 6 and 12 months after randomization. Discussion The Strongest Families Smart Website intervention is hypothesized to improve parenting skills, reduce child disruptive behaviour, reduce parental distress and improve family functioning. These results will likely inform subsequent investigations, public policy, and early treatment of childhood disruptive behaviour problems. Trial registration ClinicalTrials.gov # NCT01750996 PMID:24139323

  5. Attention deficit/hyperactivity disorder and risk of injuries: A systematic review and meta-analysis

    PubMed Central

    Amiri, Shahrokh; Sadeghi-Bazargani, Homayoun; Nazari, Soulmaz; Ranjbar, Fatemeh; Abdi, Salman

    2017-01-01

    Abstract: Background: This study systematically reviewed the literature in order to determine the effect of Attention-Deficit Hyperactivity Disorder (ADHD) on injuries and assessed the magnitude of the potential association. Methods: A systematic review of the studies examining the association of ADHD and injuries was carried out across multiple databases. Odds ratios and standardized mean differences were pooled. Results: A total of 35 studies were selected for quantitative analysis. The association of ADHD and injuries was confirmed over the meta-analysis of eligible studies. The odds ratio pooled over all comparative studies was 1.96(95% CI: 1.6-2.4) using random effects model. Pooled odds ratio of 2.1 and 2.17 were calculated respectively when cohort and case-control studies or just cohort studies were included. The pooled odds ratio reduced to 1.8(CI:1.45-2.3) when studies on specific injuries were removed. For studies comparing scores of rating scales, the pooled standardized mean difference was 0.61(95% CI: 0.03-1.2). Conclusions: Those with ADHD are nearly two times more likely to be injured. PMID:28554188

  6. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    PubMed

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  7. A randomized trial of intraarterial treatment for acute ischemic stroke.

    PubMed

    Berkhemer, Olvert A; Fransen, Puck S S; Beumer, Debbie; van den Berg, Lucie A; Lingsma, Hester F; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama à Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van Rooij, Willem Jan J; van den Berg, Jan S P; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van der Lugt, Aad; van Oostenbrugge, Robert J; Majoie, Charles B L M; Dippel, Diederik W J

    2015-01-01

    In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).

  8. Effect of early amniotomy on dystocia risk and cesarean delivery in nulliparous women: a randomized clinical trial.

    PubMed

    Ghafarzadeh, Masoomeh; Moeininasab, Samira; Namdari, Mehrdad

    2015-08-01

    Artificial rupture of amniotic membranes (amniotomy) which induces or accelerates labor is the most common obstetrical procedure. There is controversy about the effect of early amniotomy on dystocia and cesarean delivery. The study aim was to determine the effect of early amniotomy on the risk of dystocia and cesarean delivery in nulliparous women. This randomized controlled clinical trial was conducted on 300 nulliparous women. They were randomly assigned into the experimental (early amniotomy; artificial amniotomy at cervical dilation ≤ 4 cm) and control (routine management) groups (each 150 women). Length of labor, dystocia, cesarean delivery, placental abruption, and umbilical cord prolapse were compared between the groups. Early amniotomy shortened labor duration significantly in experimental group (7.5 ± 0.7 h) compared to control group (9.9 ± 1.0 h) (P < 0.001). Dystocia (6.7 vs. 25.3 %, P < 0.0001), cesarean delivery (11.3 vs. 39.3 %, P < 0.001), and placental abruption (4.7 vs. 13.3 %, P = 0.009) were significantly lower in experimental group compared to the control group. Multiple logistic regression showed that early amniotomy decreased the odds of dystocia 80.6 % (95 % CI 58.6-90.1 %) and the odds of cesarean section 81.7 % (95 % CI 66.2-90.1 %). Early amniotomy was associated with lower rate of dystocia and cesarean delivery as well as shorter duration of labor.

  9. A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

    PubMed

    Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

    2017-02-01

    To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

  10. Yo Puedo - a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in San Francisco

    PubMed Central

    Minnis, Alexandra M.; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S.

    2014-01-01

    Purpose We designed and evaluated for feasibility an intervention - Yo Puedo - that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing. Methods Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions, and targeted youth 16 to 21 years old and same-aged members of their social network. We conducted a 2-arm study with social networks randomized to the intervention or a standard services control arm. We evaluated intervention uptake, adherence and safety; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and STI risk. Results Seventy-two social networks comprised of 162 youth enrolled, with 92% retention over six months. Seventy-two percent of youth randomized to the intervention participated in intervention activities: 53% received at least one CCT payment; and 66% came to at least one life skills session. We found no evidence that cash payments financed illicit or high-risk behavior. At six months, intervention participants, compared to controls, had a lower odds of hanging out on the street frequently (OR = 0.54, p = 0.10) and a lower odds of reporting their close friends had been incarcerated (OR = 0.6, p=0.12). They reported less regular alcohol use (OR = 0.54, p=0.04) and a lower odds of having sex (OR = 0.50, p = 0.04). Conclusions The feasibility evaluation of Yo Puedo demonstrated its promise; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted. PMID:24518532

  11. KiVa Anti-Bullying Program in Italy: Evidence of Effectiveness in a Randomized Control Trial.

    PubMed

    Nocentini, Annalaura; Menesini, Ersilia

    2016-11-01

    The present study aims to evaluate the effectiveness of the KiVa anti-bullying program in Italy through a randomized control trial of students in grades 4 and 6. The sample involved 2042 students (51 % female; grade 4, mean age = 8.85; ds = 0.43; grade 6, mean age = 10.93; ds = 0.50); 13 comprehensive schools were randomly assigned into intervention (KiVa) or control (usual school provision) conditions. Different outcomes (bullying, victimization, pro-bullying attitudes, pro-victim attitudes, empathy toward victims), analyses (longitudinal mixed model with multiple-item scales; longitudinal prevalence of bullies and victims using Olweus' single question), and estimates of effectiveness (Cohen's d; odds ratios) were considered in order to compare the Italian results with those from other countries. Multilevel models showed that KiVa reduced bullying and victimization and increased pro-victim attitudes and empathy toward the victim in grade 4, with effect sizes from 0.24 to 0.40. In grade 6, KiVa reduced bullying, victimization, and pro-bullying attitudes; the effects were smaller as compared to grade 4, yet significant (d ≥ 0.20). Finally, using Olweus dichotomous definition of bullies and victims, results showed that the odds of being a victim were 1.93 times higher for a control student than for a KiVa student in grade 4. Overall, the findings provide evidence of the effectiveness of the program in Italy; the discussion will focus on factors that influenced successfully the transportability of the KiVa program in Italy.

  12. A randomized trial of effects of health risk appraisal combined with group sessions or home visits on preventive behaviors in older adults.

    PubMed

    Dapp, Ulrike; Anders, Jennifer A M; von Renteln-Kruse, Wolfgang; Minder, Christoph E; Meier-Baumgartner, Hans Peter; Swift, Cameron G; Gillmann, Gerhard; Egger, Matthias; Beck, John C; Stuck, Andreas E

    2011-05-01

    To explore effects of a health risk appraisal for older people (HRA-O) program with reinforcement, we conducted a randomized controlled trial in 21 general practices in Hamburg, Germany. Overall, 2,580 older patients of 14 general practitioners trained in reinforcing recommendations related to HRA-O-identified risk factors were randomized into intervention (n = 878) and control (n = 1,702) groups. Patients (n = 746) of seven additional matched general practitioners who did not receive this training served as a comparison group. Patients allocated to the intervention group, and their general practitioners, received computer-tailored written recommendations, and patients were offered the choice between interdisciplinary group sessions (geriatrician, physiotherapist, social worker, and nutritionist) and home visits (nurse). Among the intervention group, 580 (66%) persons made use of personal reinforcement (group sessions: 503 [87%], home visits: 77 [13%]). At 1-year follow-up, persons in the intervention group had higher use of preventive services (eg, influenza vaccinations, adjusted odds ratio 1.7; 95% confidence interval 1.4-2.1) and more favorable health behavior (eg, high fruit/fiber intake, odds ratio 2.0; 95% confidence interval 1.6-2.6), as compared with controls. Comparisons between intervention and comparison group data revealed similar effects, suggesting that physician training alone had no effect. Subgroup analyses indicated favorable effects for HRA-O with personal reinforcement, but not for HRA-O without reinforcement. HRA-O combined with physician training and personal reinforcement had favorable effects on preventive care use and health behavior.

  13. Mindfulness Based Relapse Prevention for Stimulant Dependent Adults: A Pilot Randomized Clinical Trial.

    PubMed

    Glasner-Edwards, Suzette; Mooney, Larissa J; Ang, Alfonso; Garneau, Hélène Chokron; Hartwell, Emily; Brecht, Mary-Lynn; Rawson, Richard A

    2017-02-01

    In light of the known associations between stress, negative affect, and relapse, mindfulness strategies hold promise as a means of reducing relapse susceptibility. In a pilot randomized clinical trial, we evaluated the effects of Mindfulness Based Relapse Prevention (MBRP), relative to a health education control condition (HE) among stimulant dependent adults receiving contingency management. All participants received a 12-week contingency management (CM) intervention. Following a 4-week CM-only lead in phase, participants were randomly assigned to concurrently receive MBRP (n=31) or HE (n=32). Stimulant dependent adults age 18 and over. A university based clinical research center. The primary outcomes were stimulant use, measured by urine drug screens weekly during the intervention and at 1-month post-treatment, negative affect, measured by the Beck Depression Inventory and Beck Anxiety Inventory, and psychiatric severity, measured by the Addiction Severity Index. Medium effect sizes favoring MBRP were observed for negative affect and overall psychiatric severity outcomes. Depression severity changed differentially over time as a function of group, with MBRP participants reporting greater reductions through follow-up (p=0.03; Effect Size=0.58). Likewise, the MBRP group evidenced greater declines in psychiatric severity, (p=0.01; Effect Size=0.61 at follow-up). Among those with depressive and anxiety disorders, MBRP was associated with lower odds of stimulant use relative to the control condition (Odds Ratio= 0.78, p=0.03 and OR=0.68, p=0.04). MBRP effectively reduces negative affect and psychiatric impairment, and is particularly effective in reducing stimulant use among stimulant dependent adults with mood and anxiety disorders.

  14. Even and odd normalized zero modes in random interacting Majorana models respecting the parity P and the time-reversal-symmetry T

    NASA Astrophysics Data System (ADS)

    Monthus, Cécile

    2018-06-01

    For random interacting Majorana models where the only symmetries are the parity P and the time-reversal-symmetry T, various approaches are compared to construct exact even and odd normalized zero modes Γ in finite size, i.e. Hermitian operators that commute with the Hamiltonian, that square to the identity, and that commute (even) or anticommute (odd) with the parity P. Even normalized zero-modes are well known under the name of ‘pseudo-spins’ in the field of many-body-localization or more precisely ‘local integrals of motion’ (LIOMs) in the many-body-localized-phase where the pseudo-spins happens to be spatially localized. Odd normalized zero-modes are popular under the name of ‘Majorana zero modes’ or ‘strong zero modes’. Explicit examples for small systems are described in detail. Applications to real-space renormalization procedures based on blocks containing an odd number of Majorana fermions are also discussed.

  15. Risk factors for postoperative intraretinal cystoid changes after peeling of idiopathic epiretinal membranes among patients randomized for balanced salt solution and air-tamponade.

    PubMed

    Leisser, Christoph; Hirnschall, Nino; Hackl, Christoph; Döller, Birgit; Varsits, Ralph; Ullrich, Marlies; Kefer, Katharina; Karl, Rigal; Findl, Oliver

    2018-02-20

    Epiretinal membranes (ERM) are macular disorders leading to loss of vision and metamorphopsia. Vitrectomy with membrane peeling displays the gold standard of care. Aim of this study was to assess risk factors for postoperative intraretinal cystoid changes in a study population randomized for balanced salt solution and air-tamponade at the end of surgery. A prospective randomized study, including 69 eyes with idiopathic ERM. Standard 23-gauge three-port pars plana vitrectomy with membrane peeling, using intraoperative optical coherence tomography (OCT), was performed. Randomization for BSS and air-tamponade was performed prior to surgery. Best-corrected visual acuity improved from 32.9 letters to 45.1 letters 3 months after surgery. Presence of preoperative intraretinal cystoid changes was found to be the only risk factor for presence of postoperative intraretinal cystoid changes 3 months after surgery (p = 0.01; odds ratio: 8.0). Other possible risk factors such as combined phacoemulsification with 23G-ppv and membrane peeling (p = 0.16; odds ratio: 2.4), intraoperative subfoveal hyporeflective zones (p = 0.23; odds ratio: 2.6), age over 70 years (p = 0.29; odds ratio: 0.5) and air-tamponade (p = 0.59; odds ratio: 1.5) were not found to be significant. There is strong evidence that preoperative intraretinal cystoid changes lead to smaller benefit from surgery. © 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  16. Effect of playing tactics on achieving score-box possessions in a random series of team possessions from Norwegian professional soccer matches.

    PubMed

    Tenga, Albin; Holme, Ingar; Ronglan, Lars Tore; Bahr, Roald

    2010-02-01

    Methods of analysis that include an assessment of opponent interactions are thought to provide a more valid means of team match performance. The purpose of this study was to examine the effect of playing tactics on achieving score-box possession by assessing opponent interactions in Norwegian elite soccer matches. We analysed a random series of 1703 team possessions from 163 of 182 (90%) matches played in the professional men's league during the 2004 season. Multidimensional qualitative data obtained from ten ordered categorical variables were used. Offensive tactics were more effective in producing score-box possessions when playing against an imbalanced defence (28.5%) than against a balanced defence (6.5%) (P < 0.001). Multiple logistic regression found that, for the main variable "team possession type", counterattacks were more effective than elaborate attacks when playing against an imbalanced defence (odds ratio: 2.69; 95% confidence interval: 1.64 to 4.43) but not against a balanced defence (odds ratio: 1.14; 95% confidence interval: 0.47 to 2.76). Assessment of opponent interactions is critical to evaluate the effectiveness of offensive playing tactics on producing score-box possessions, and improves the validity of team match-performance analysis in soccer.

  17. Improving the Odds for Children of Teen Mothers: What Matters Most?

    ERIC Educational Resources Information Center

    Vogel, Cheri A.

    This study looked at New Chance, a voluntary randomized trial of an intensive program for teenage mothers and their children that operated nationally between 1989 and 1992. The study examined the effects of maternal psychosocial well being, intensity of work and educational pursuits, home environment, and use of childcare on combined experimental…

  18. The Pharmacological Management of Oppositional Behaviour, Conduct Problems, and Aggression in Children and Adolescents With Attention-Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, and Conduct Disorder: A Systematic Review and Meta-Analysis. Part 1: Psychostimulants, Alpha-2 Agonists, and Atomoxetine

    PubMed Central

    Pringsheim, Tamara; Hirsch, Lauren; Gardner, David; Gorman, Daniel A

    2015-01-01

    Objective: Children with attention-deficit hyperactivity disorder (ADHD) may have oppositional behaviour, conduct problems, and aggression. These symptoms vary in severity, and may be related to a comorbid diagnosis of oppositional defiant disorder (ODD) or conduct disorder (CD). Critical evaluation of the efficacy of ADHD medications may guide the clinician regarding the usefulness of medications for these symptoms. Method: We performed a systematic review and meta-analysis of psychostimulants, alpha-2 agonists, and atomoxetine for oppositional behaviour, conduct problems, and aggression in youth with ADHD, ODD, and CD. The quality of evidence for medications was rated using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Two systematic reviews and 20 randomized controlled trials were included. There is high-quality evidence that psychostimulants have a moderate-to-large effect on oppositional behaviour, conduct problems, and aggression in youth with ADHD, with and without ODD or CD. There is very-low-quality evidence that clonidine has a small effect on oppositional behaviour and conduct problems in youth with ADHD, with and without ODD or CD. There is moderate-quality evidence that guanfacine has a small-to-moderate effect on oppositional behaviour in youth with ADHD, with and without ODD. There is high-quality evidence that atomoxetine has a small effect on oppositional behaviour in youth with ADHD, with and without ODD or CD. Conclusions: Evidence indicates that psychostimulants, alpha-2 agonists, and atomoxetine can be beneficial for disruptive and aggressive behaviours in addition to core ADHD symptoms; however, psychostimulants generally provide the most benefit. PMID:25886655

  19. The pharmacological management of oppositional behaviour, conduct problems, and aggression in children and adolescents with attention-deficit hyperactivity disorder, oppositional defiant disorder, and conduct disorder: a systematic review and meta-analysis. Part 1: psychostimulants, alpha-2 agonists, and atomoxetine.

    PubMed

    Pringsheim, Tamara; Hirsch, Lauren; Gardner, David; Gorman, Daniel A

    2015-02-01

    Children with attention-deficit hyperactivity disorder (ADHD) may have oppositional behaviour, conduct problems, and aggression. These symptoms vary in severity, and may be related to a comorbid diagnosis of oppositional defiant disorder (ODD) or conduct disorder (CD). Critical evaluation of the efficacy of ADHD medications may guide the clinician regarding the usefulness of medications for these symptoms. We performed a systematic review and meta-analysis of psychostimulants, alpha-2 agonists, and atomoxetine for oppositional behaviour, conduct problems, and aggression in youth with ADHD, ODD, and CD. The quality of evidence for medications was rated using the Grading of Recommendations Assessment, Development and Evaluation approach. Two systematic reviews and 20 randomized controlled trials were included. There is high-quality evidence that psychostimulants have a moderate-to-large effect on oppositional behaviour, conduct problems, and aggression in youth with ADHD, with and without ODD or CD. There is very-low-quality evidence that clonidine has a small effect on oppositional behaviour and conduct problems in youth with ADHD, with and without ODD or CD. There is moderate-quality evidence that guanfacine has a small-to-moderate effect on oppositional behaviour in youth with ADHD, with and without ODD. There is high-quality evidence that atomoxetine has a small effect on oppositional behaviour in youth with ADHD, with and without ODD or CD. Evidence indicates that psychostimulants, alpha-2 agonists, and atomoxetine can be beneficial for disruptive and aggressive behaviours in addition to core ADHD symptoms; however, psychostimulants generally provide the most benefit.

  20. Use of Peritoneal Dialysis in AKI: A Systematic Review

    PubMed Central

    Chionh, Chang Yin; Soni, Sachin S.; Finkelstein, Fredric O.; Ronco, Claudio

    2013-01-01

    Summary Background and objectives The role of peritoneal dialysis in the management of AKI is not well defined, although it remains frequently used, especially in low-resource settings. A systematic review was performed to describe outcomes in AKI treated with peritoneal dialysis and compare peritoneal dialysis with extracorporeal blood purification, such as continuous or intermittent hemodialysis. Design, setting, participants, & measurements MEDLINE, CINAHL, and Central Register of Controlled Trials were searched in July of 2012. Eligible studies selected were observational cohort or randomized adult population studies on peritoneal dialysis in the setting of AKI. The primary outcome of interest was all-cause mortality. Summary estimates of odds ratio were obtained using a random effects model. Results Of 982 citations, 24 studies (n=1556 patients) were identified. The overall methodological quality was low. Thirteen studies described patients (n=597) treated with peritoneal dialysis only; pooled mortality was 39.3%. In 11 studies (7 cohort studies and 4 randomized trials), patients received peritoneal dialysis (n=392, pooled mortality=58.0%) or extracorporeal blood purification (n=567, pooled mortality=56.1%). In the cohort studies, there was no difference in mortality between peritoneal dialysis and extracorporeal blood purification (odds ratio, 0.96; 95% confidence interval, 0.53 to 1.71). In four randomized trials, there was also no difference in mortality (odds ratio, 1.50; 95% confidence interval, 0.46 to 4.86); however, heterogeneity was significant (I2=73%, P=0.03). Conclusions There is currently no evidence to suggest significant differences in mortality between peritoneal dialysis and extracorporeal blood purification in AKI. There is a need for good-quality evidence in this important area. PMID:23833316

  1. Albumin infusion improves outcomes of patients with spontaneous bacterial peritonitis: a meta-analysis of randomized trials.

    PubMed

    Salerno, Francesco; Navickis, Roberta J; Wilkes, Mahlon M

    2013-02-01

    Renal impairment increases mortality among patients with spontaneous bacterial peritonitis (SBP), despite administration of non-nephrotoxic antibiotics. Albumin infusion has been reported to reduce renal impairment and mortality in patients with SBP. We performed a meta-analysis of randomized controlled trials (RCTs) to quantify the effect of albumin infusion on renal impairment and mortality in patients with SBP. We searched MEDLINE, EMBASE, the Cochrane Library, and ClinicalTrials.gov for RCTs that evaluated albumin treatment for patients with SBP; we also performed searches by additional methods. Four trials of 288 total patients were included in our analysis. Data were quantitatively combined under a fixed-effects model. We found no evidence of statistically significant heterogeneity or publication bias among the studies analyzed. Albumin was compared with no albumin in 3 trials and with artificial colloid in 1 trial. All patients received antibiotics. The incidence of renal impairment in control groups was 44 of 144 (30.6%), compared with 12 of 144 (8.3%) in groups given albumin. The pooled odds ratio for a reduction in renal impairment after albumin infusion was 0.21 (95% confidence interval, 0.11-0.42). Odds ratios for renal impairment after albumin therapy ranged from 0.19-0.30 among the individual studies. Mortality among controls was 51 of 144 (35.4%), compared with 23 of 144 (16.0%) among patients who received albumin. The pooled odds ratio for decreased mortality after infusion of albumin was 0.34 (95% confidence interval, 0.19-0.60). Odds ratios for mortality in individual RCTs ranged from 0.16-0.55. In a meta-analysis of 4 RCTs (288 patients), albumin infusion prevented renal impairment and reduced mortality among patients with SBP. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

  2. A Randomized Study of How Physicians Interpret Research Funding Disclosures

    PubMed Central

    Kesselheim, Aaron S.; Robertson, Christopher T.; Myers, Jessica A.; Rose, Susannah L.; Gillet, Victoria; Ross, Kathryn M.; Glynn, Robert J.; Joffe, Steven; Avorn, Jerry

    2012-01-01

    BACKGROUND The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor. METHODS We presented 503 board-certified internists with abstracts that we designed describing clinical trials of three hypothetical drugs. The trials had high, medium, or low methodologic rigor, and each report included one of three support disclosures: funding from a pharmaceutical company, NIH funding, or none. For both factors studied (rigor and funding), one of the three possible variations was randomly selected for inclusion in the abstracts. Follow-up questions assessed the physicians’ impressions of the trials’ rigor, their confidence in the results, and their willingness to prescribe the drugs. RESULTS The 269 respondents (53.5% response rate) perceived the level of study rigor accurately. Physicians reported that they would be less willing to prescribe drugs tested in low-rigor trials than those tested in medium-rigor trials (odds ratio, 0.64; 95% confidence interval [CI], 0.46 to 0.89; P = 0.008) and would be more willing to prescribe drugs tested in high-rigor trials than those tested in medium-rigor trials (odds ratio, 3.07; 95% CI, 2.18 to 4.32; P<0.001). Disclosure of industry funding, as compared with no disclosure of funding, led physicians to downgrade the rigor of a trial (odds ratio, 0.63; 95% CI, 0.46 to 0.87; P = 0.006), their confidence in the results (odds ratio, 0.71; 95% CI, 0.51 to 0.98; P = 0.04), and their willingness to prescribe the hypothetical drugs (odds ratio, 0.68; 95% CI, 0.49 to 0.94; P = 0.02). Physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials (odds ratio, 0.52; 95% CI, 0.37 to 0.71; P<0.001). These effects were consistent across all levels of methodologic rigor. CONCLUSIONS Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial’s quality. These effects may influence the translation of clinical research into practice. PMID:22992075

  3. Early Postmenopausal Transdermal 17β-Estradiol Therapy and Amyloid-β Deposition.

    PubMed

    Kantarci, Kejal; Lowe, Val J; Lesnick, Timothy G; Tosakulwong, Nirubol; Bailey, Kent R; Fields, Julie A; Shuster, Lynne T; Zuk, Samantha M; Senjem, Matthew L; Mielke, Michelle M; Gleason, Carey; Jack, Clifford R; Rocca, Walter A; Miller, Virginia M

    2016-05-07

    It remains controversial whether hormone therapy in recently postmenopausal women modifies the risk of Alzheimer's disease (AD). To investigate the effects of hormone therapy on amyloid-β deposition in recently postmenopausal women. Participants within 5-36 months past menopause in the Kronos Early Estrogen Prevention Study, a randomized, double blinded placebo-controlled clinical trial, were randomized to: 1) 0.45 mg/day oral conjugated equine estrogens (CEE); 2) 50μg/day transdermal 17β-estradiol; or 3) placebo pills and patch for four years. Oral progesterone (200 mg/day) was given to active treatment groups for 12 days each month. 11C Pittsburgh compound B (PiB) PET imaging was performed in 68 of the 118 participants at Mayo Clinic approximately seven years post randomization and three years after stopping randomized treatment. PiB Standard unit value ratio (SUVR) was calculated. Women (age = 52-65) randomized to transdermal 17β-estradiol (n = 21) had lower PiB SUVR compared to placebo (n = 30) after adjusting for age [odds ratio (95% CI) = 0.31(0.11-0.83)]. In the APOEɛ4 carriers, transdermal 17β-estradiol treated women (n = 10) had lower PiB SUVR compared to either placebo (n = 5) [odds ratio (95% CI) = 0.04(0.004-0.44)], or the oral CEE treated group (n = 3) [odds ratio (95% CI) = 0.01(0.0006-0.23)] after adjusting for age. Hormone therapy was not associated with PiB SUVR in the APOEɛ4 non-carriers. In this pilot study, transdermal 17β-estradiol therapy in recently postmenopausal women was associated with a reduced amyloid-β deposition, particularly in APOEɛ4 carriers. This finding may have important implications for the prevention of AD in postmenopausal women, and needs to be confirmed in a larger sample.

  4. Physical Activity and Incident Depression: A Meta-Analysis of Prospective Cohort Studies.

    PubMed

    Schuch, Felipe B; Vancampfort, Davy; Firth, Joseph; Rosenbaum, Simon; Ward, Philip B; Silva, Edson S; Hallgren, Mats; Ponce De Leon, Antonio; Dunn, Andrea L; Deslandes, Andrea C; Fleck, Marcelo P; Carvalho, Andre F; Stubbs, Brendon

    2018-04-25

    The authors examined the prospective relationship between physical activity and incident depression and explored potential moderators. Prospective cohort studies evaluating incident depression were searched from database inception through Oct. 18, 2017, on PubMed, PsycINFO, Embase, and SPORTDiscus. Demographic and clinical data, data on physical activity and depression assessments, and odds ratios, relative risks, and hazard ratios with 95% confidence intervals were extracted. Random-effects meta-analyses were conducted, and the potential sources of heterogeneity were explored. Methodological quality was assessed using the Newcastle-Ottawa Scale. A total of 49 unique prospective studies (N=266,939; median proportion of males across studies, 47%) were followed up for 1,837,794 person-years. Compared with people with low levels of physical activity, those with high levels had lower odds of developing depression (adjusted odds ratio=0.83, 95% CI=0.79, 0.88; I 2 =0.00). Furthermore, physical activity had a protective effect against the emergence of depression in youths (adjusted odds ratio=0.90, 95% CI=0.83, 0.98), in adults (adjusted odds ratio=0.78, 95% CI=0.70, 0.87), and in elderly persons (adjusted odds ratio=0.79, 95% CI=0.72, 0.86). Protective effects against depression were found across geographical regions, with adjusted odds ratios ranging from 0.65 to 0.84 in Asia, Europe, North America, and Oceania, and against increased incidence of positive screen for depressive symptoms (adjusted odds ratio=0.84, 95% CI=0.79, 0.89) or major depression diagnosis (adjusted odds ratio=0.86, 95% CI=0.75, 0.98). No moderators were identified. Results were consistent for unadjusted odds ratios and for adjusted and unadjusted relative risks/hazard ratios. Overall study quality was moderate to high (Newcastle-Ottawa Scale score, 6.3). Although significant publication bias was found, adjusting for this did not change the magnitude of the associations. Available evidence supports the notion that physical activity can confer protection against the emergence of depression regardless of age and geographical region.

  5. Gender Modifies the Effect of Ursodeoxycholic Acid (UDCA) in a Randomized Controlled Trial in Colorectal Adenoma Patients

    PubMed Central

    Thompson, Patricia A.; Wertheim, Betsy C.; Roe, Denise J.; Ashbeck, Erin L.; Jacobs, Elizabeth T.; Lance, Peter; Martínez, María Elena; Alberts, David S.

    2014-01-01

    Background Ursodeoxycholic acid (UDCA) was one of the earliest agents investigated as a drug for colorectal cancer prevention. However, UDCA failed to demonstrate efficacy to prevent the development of colorectal adenomas in a large phase III randomized controlled trial. We re-evaluated the effect of UDCA in men and women separately, based on sex-specific differences in bile acid metabolism and suspected variation in etiologic factors contributing to colorectal cancer risk. Method We conducted a secondary analysis of the efficacy of UDCA to prevent colorectal adenoma in men (n = 804) and women (n = 388). Results We found no reduction in risk of any metachronous adenoma with UDCA treatment in men or women. However, UDCA treatment significantly lowered the odds of advanced lesions (OR = 0.62, 95% CI = 0.43 to 0.89) in men, but not women. We also observed significantly higher odds of advanced lesions with UDCA treatment in women who were younger (age < 65 y; OR = 3.24, 95% CI = 1.10 to 9.56), obese (body mass index ≥ 30 kg/m2; OR = 5.45, 95% CI = 1.42 to 20.9), or in the highest tertile of total dietary fat (≥ 56.2 g/day; OR = 3.48, 95% CI = 1.35 to 8.95). The interactive effect of fat intake accounted for the modulating effects of age and BMI in women. Conclusion Our findings support the use of UDCA for preventing advanced colorectal adenomas in men. The increased odds of adenoma among women with high fat intake suggest a previously unrecognized harm that warrants further study, especially given some patients’ chronic exposure to UDCA for the treatment of primary biliary cirrhosis and the rising investigational use of this drug for several other conditions. PMID:19952360

  6. Explaining the relationship between temperament and symptoms of psychiatric disorders from preschool to middle childhood: hybrid fixed and random effects models of Norwegian and Spanish children.

    PubMed

    Wichstrøm, Lars; Penelo, Eva; Rensvik Viddal, Kristine; de la Osa, Nuria; Ezpeleta, Lourdes

    2018-03-01

    Four explanations for the concurrent and prospective associations between temperament and psychopathology in children have been suggested: predisposition, complication/scar, common cause/continuity, and pathoplasty/exacerbation. Because the confounding effects of common causes have not been ruled out in prior work, the support for the various explanations is uncertain. Screen-stratified community samples of 4-year olds in Trondheim, Norway (n = 1,042), and 3-year olds in Barcelona, Spain (n = 622), were assessed biennially for symptoms of attention-deficit/hyperactivity (ADHD), oppositional defiant (ODD), conduct (CD), anxiety, and depressive disorders through interviewer-based psychiatric interviews across four waves of data collection. The parents completed child temperament ratings. The data were analyzed with random and fixed effects regression adjusted for all time-invariant unmeasured confounders (e.g., genetics, common methods bias, item overlap). In both Norway and Spain and across ages, negative affect predisposed children to symptoms of all disorders except CD, low effortful control predisposed children to ADHD and ODD-symptoms, and surgency predisposed children to increased ADHD-symptoms. Complication effects were observed in the Spanish children for ADHD-symptoms, which increased surgency and diminished effortful control, and for ODD-symptoms, which decreased surgency. The common cause and pathoplasty/exacerbation explanations were not supported. The present results are consistent with the view that temperament plays a causal role in the development of symptoms of psychiatric disorders in children. Because temperament is malleable, interventions targeting the affective, attentional, and behavioral regulatory components of temperament may reduce psychopathology in children. © 2017 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  7. A meta-analysis of randomized trials assessing the effects of probiotic preparations on oral candidiasis in the elderly.

    PubMed

    Ai, Ruixue; Wei, Jiao; Ma, Danhua; Jiang, Lu; Dan, Hongxia; Zhou, Yu; Ji, Ning; Zeng, Xin; Chen, Qianming

    2017-11-01

    Oral candidiasis is the most common fungal infection and can be attributed in part to dysbiosis, an imbalance in the resident oral microflora. Therefore, probiotics, which counter pathogenic microorganisms through competitive, antagonistic, and immunological effects, have been used by some clinicians. To date, the effect of probiotics in preventing oral candidiasis in the elderly is controversial. A systematic review that summarizes and critically appraises the available clinical trials is therefore necessary. Electronic searches were performed using the Pubmed, Embase, and Cochrane databases. Only randomized controlled trials were included. The Mantel-Haenszel test was used to appraise the odds ratio for single studies and an overall combined odds ratio for all studies combined. Three studies matched the inclusion criteria and were homogeneous. The data from one study that estimated candida growth from plaque and saliva were subdivided, thus a total of four studies with 595 people were included. The overall combined odds ratio was 0.54 (95% CI: 0.38-0.77). Three studies provided that active treatment reduced the risk of oral candidiasis more than placebo: Hatakka et al. (OR 0.51, 95% CI 0.26 to 0.97; 192 participants, plaque); Kraft-Bodi et al. (OR 0.46, 95% CI 0.24 to 0.86; 174 participants, palatal); Kraft-Bodi et al. (OR 0.50, 95% CI 0.26 to 0.98; 174 participants, plaque), while one study provided reverse result: Ishikawa et al. (OR 1.24, 95% CI 0.48 to 3.58; 55 participants, saliva). Probiotics have a preventative effect on oral candidiasis in the elderly. Copyright © 2017. Published by Elsevier Ltd.

  8. A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis

    PubMed Central

    Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

    2017-01-01

    Purpose To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. Methods A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan- uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts’ estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial’s primary outcome. Results 11 of 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03 – 45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1–1.2) and 0.7 (95% CrI 0.2–1.7) from the Bayesian analysis. Conclusions A Bayesian analysis combining expert belief with the trial’s result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT. PMID:27982726

  9. Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in adult hospitalized patients: a single-center, randomized, double-blind, placebo-controlled trial.

    PubMed

    Pozzoni, Pietro; Riva, Alessia; Bellatorre, Alessandro Giacco; Amigoni, Maria; Redaelli, Elena; Ronchetti, Anna; Stefani, Mariangela; Tironi, Rosangela; Molteni, Edoardo Ennio; Conte, Dario; Casazza, Giovanni; Colli, Agostino

    2012-06-01

    Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Probiotics were effective in preventing AAD and CDAD in several randomized controlled trials. This study was aimed at testing the effect of Saccharomyces boulardii on the occurrence of AAD and CDAD in hospitalized patients. A single-center, randomized, double-blind, placebo-controlled, parallel-group trial was performed. Patients being prescribed antibiotics or on antibiotic therapy for <48 h were eligible. Exclusion criteria were ongoing diarrhea, recent assumption of probiotics, lack of informed consent, inability to ingest capsules, and severe pancreatitis. Patients received a capsule containing S. boulardii or an indistinguishable placebo twice daily within 48 h of beginning antibiotic therapy, continued treatment for 7 days after antibiotic withdrawal, and were followed for 12 weeks after ending antibiotic treatment. Of 562 consecutive eligible patients, 275 patients aged 79.2 ± 9.8 years (134 on placebo) were randomized and 204 aged 78.4 ± 10.0 years (98 on placebo) completed the follow-up. AAD developed in 13.3% (13/98) of the patients receiving placebo and in 15.1% (16/106) of those receiving S. boulardii (odds ratio for S. boulardii vs. placebo, 1.16; 95% confidence interval (CI), 0.53-2.56). Five cases of CDAD occurred, 2 in the placebo group (2.0%) and 3 in the probiotic group (2.8%; odds ratio for S. boulardii vs. placebo, 1.40; 95% CI, 0.23-8.55). There was no difference in mortality rates (12.7% vs. 15.6%, P=0.60). In elderly hospitalized patients, S. boulardii was not effective in preventing the development of AAD.

  10. A meta-analysis of Th2 pathway genetic variants and risk for allergic rhinitis.

    PubMed

    Bunyavanich, Supinda; Shargorodsky, Josef; Celedón, Juan C

    2011-06-01

    There is a significant genetic contribution to allergic rhinitis (AR). Genetic association studies for AR have been performed, but varying results make it challenging to decipher the overall potential effect of specific variants. The Th2 pathway plays an important role in the immunological development of AR. We performed meta-analyses of genetic association studies of variants in Th2 pathway genes and AR. PubMed and Phenopedia were searched by double extraction for original studies on Th2 pathway-related genetic polymorphisms and their associations with AR. A meta-analysis was conducted on each genetic polymorphism with data meeting our predetermined selection criteria. Analyses were performed using both fixed and random effects models, with stratification by age group, ethnicity, and AR definition where appropriate. Heterogeneity and publication bias were assessed. Six independent studies analyzing three candidate polymorphisms and involving a total of 1596 cases and 2892 controls met our inclusion criteria. Overall, the A allele of IL13 single nucleotide polymorphism (SNP) rs20541 was associated with increased odds of AR (estimated OR=1.2; 95% CI 1.1-1.3, p-value 0.004 in fixed effects model, 95% CI 1.0-1.5, p-value 0.056 in random effects model). The A allele of rs20541 was associated with increased odds of AR in mixed age groups using both fixed effects and random effects modeling. IL13 SNP rs1800925 and IL4R SNP 1801275 did not demonstrate overall associations with AR. We conclude that there is evidence for an overall association between IL13 SNP rs20541 and increased risk of AR, especially in mixed-age populations. © 2011 John Wiley & Sons A/S.

  11. Statin therapy in lower limb peripheral arterial disease: Systematic review and meta-analysis.

    PubMed

    Antoniou, George A; Fisher, Robert K; Georgiadis, George S; Antoniou, Stavros A; Torella, Francesco

    2014-11-01

    To investigate and analyse the existing evidence supporting statin therapy in patients with lower limb atherosclerotic arterial disease. A systematic search of electronic information sources was undertaken to identify studies comparing cardiovascular outcomes in patients with lower limb peripheral arterial disease treated with a statin and those not receiving a statin. Estimates were combined applying fixed- or random-effects models. Twelve observational cohort studies and two randomised trials reporting 19,368 patients were selected. Statin therapy was associated with reduced all-cause mortality (odds ratio 0.60, 95% confidence interval 0.46-0.78) and incidence of stroke (odds ratio 0.77, 95% confidence interval 0.67-0.89). A trend towards improved cardiovascular mortality (odds ratio 0.62, 95% confidence interval 0.35-1.11), myocardial infarction (odds ratio 0.62, 95% confidence interval 0.38-1.01), and the composite of death/myocardial infarction/stroke (odds ratio 0.91, 95% confidence interval 0.81-1.03), was identified. Meta-analyses of studies performing adjustments showed decreased all-cause mortality in statin users (hazard ratio 0.77, 95% confidence interval 0.68-0.86). Evidence supporting statins' protective role in patients with lower limb peripheral arterial disease is insufficient. Statin therapy seems to be effective in reducing all-cause mortality and the incidence cerebrovascular events in patients diagnosed with peripheral arterial disease. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Continued smoking abstinence in diabetic patients in primary care: a cluster randomized controlled multicenter study.

    PubMed

    Pérez-Tortosa, Santiago; Roig, Lydia; Manresa, Josep M; Martin-Cantera, Carlos; Puigdomènech, Elisa; Roura, Pilar; Armengol, Angelina; Advani, Mamta

    2015-01-01

    To assess the effectiveness of an intensive smoking cessation intervention based on the transtheoretical model of change (TTM) in diabetic smokers attending primary care. A cluster randomized controlled clinical trial was designed in which the unit of randomization (intervention vs. usual care) was the primary care team. An intensive, individualized intervention using motivational interview and therapies and medications adapted to the patient's stage of change was delivered. The duration of the study was 1 year. A total of 722 people with diabetes who were smokers (345 in the intervention group and 377 in the control group) completed the study. After 1 year, continued abstinence was recorded in 90 (26.1%) patients in the intervention group and in 67 (17.8%) controls (p=0.007). In patients with smoking abstinence, there was a higher percentage in the precontemplation and contemplation stages at baseline in the intervention group than in controls (21.2% vs. 13.7%, p=0.024). When the precontemplation stage was taken as reference (OR=1.0), preparation/action stage at baseline showed a protective effect, decreasing 3.41 times odds of continuing smoking (OR=0.293 95% CI 0.179-0.479, p<0.001). Contemplation stage at baseline also showed a protective effect, decreasing the odds of continuing smoking (OR=0.518, 95% CI 0.318-0.845, p=0.008). An intensive intervention adapted to the individual stage of change delivered in primary care was feasible and effective, with a smoking cessation rate of 26.1% after 1 year. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Antibiotic and Duration of Perioperative Prophylaxis Predicts Surgical Site Infection in Head and Neck Surgery.

    PubMed

    Langerman, Alexander; Thisted, Ronald; Hohmann, Samuel; Howell, Michael

    2016-06-01

    To examine the effect of giving antibiotics on the day of surgery (DOS) vs DOS and first postoperative day (DOS+1) for prophylaxis against surgical site infection (SSI) in clean-contaminated head and neck surgery (CCHNS). Retrospective multi-institution analysis using University HealthSystem Consortium data. A multivariate logistic regression model of 8836 discharge records from patients undergoing CCHNS was used to determine the odds of SSI for antibiotic agent/duration combinations. Ninety-two academic and affiliated medical centers from 2008 to 2011. Ampicillin/sulbactam, clindamycin, cefazolin + metronidazole, and cefazolin alone were the most common antibiotics. For patients receiving antibiotics only on DOS, there was no significant difference in odds of SSI based on antibiotic choice. When given on the DOS and DOS+1, patients receiving ampicillin/sulbactam had a reduction in odds of SSI by over two-thirds (odds ratio [OR], 0.28 [95% confidence interval, 0.13-0.61], P = .001, compared with ampicillin/sulbactam on DOS only), whereas this effect was not seen with clindamycin (1.82 [0.93-3.56], P = .078, compared with clindamycin on DOS only). Prolonging clindamycin beyond the DOS was associated with a higher odds of SSI compared with DOS-only ampicillin/sulbactam (OR, 2.66; 95% CI, 1.33-5.30; P = .006). These relationships held in a subset of physicians and hospitals that used multiple different regimens. DOS+1 regimens were not associated with an increased odds of antibiotic-induced complications. Prolonging ampicillin/sulbactam beyond the day of surgery may have a protective effect against SSI, and 1 or more days of ampicillin/sulbactam may be preferable to multiple days of clindamycin. New randomized trials are needed to define the ideal regimen for CCHNS. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  14. Antibiotic treatment of bacterial vaginosis in pregnancy: a meta-analysis.

    PubMed

    Leitich, Harald; Brunbauer, Mathias; Bodner-Adler, Barbara; Kaider, Alexandra; Egarter, Christian; Husslein, Peter

    2003-03-01

    The purpose of this study was to evaluate the effectiveness of antibiotic treatment of bacterial vaginosis in pregnancy to reduce preterm delivery. We performed a meta-analysis of published, English-language, randomized, placebo-controlled clinical trials of antibiotic treatment of bacterial vaginosis in pregnant women with intact amniotic membranes at <37 weeks of gestation. Primary outcomes included preterm delivery, perinatal or neonatal death, and neonatal morbidity. Ten studies with results for 3969 patients were included. In patients without preterm labor, antibiotic treatment did not significantly decrease preterm delivery at <37 weeks of gestation, in all patients combined (odds ratio, 0.83; 95% CI, 0.57-1.21) nor in high-risk patients with a previous preterm delivery (odds ratio, 0.50; 95% CI, 0.22-1.12). In both groups, significant statistical heterogeneity was observed. A significant reduction in preterm delivery and no statistical heterogeneity were observed in 338 high-risk patients who received oral regimens with treatment durations of > or =7 days (odds ratio, 0.42; 95% CI, 0.27-0.67). Nonsignificant effects and no statistical heterogeneity were observed in low-risk patients (odds ratio, 0.94; 95% CI, 0.71-1.25) and with vaginal regimens (odds ratio, 1.25; 95% CI: 0.86-1.81). In one study antibiotic treatment in patients with preterm labor led to a nonsignificant decrease in the rate of preterm deliveries (odds ratio, 0.31; 95% CI, 0.03-3.24). The screening of pregnant women who have bacterial vaginosis and who have had a previous preterm delivery and treatment with an oral regimen of longer duration can be justified on the basis of current evidence. More studies are needed to confirm the effectiveness of this strategy, both in high-risk patients without preterm labor and in patients with preterm labor.

  15. Risperidone Added to Parent Training and Stimulant Medication: Effects on Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder, Conduct Disorder, and Peer Aggression

    PubMed Central

    Gadow, Kenneth D.; Arnold, L. Eugene; Molina, Brooke S.G.; Findling, Robert L.; Bukstein, Oscar G.; Brown, Nicole V.; McNamara, Nora K.; Rundberg-Rivera, E. Victoria; Li, Xiaobai; Kipp, Heidi; Schneider, Jayne; Farmer, Cristan A.; Baker, Jennifer; Sprafkin, Joyce; Rice, Robert R.; Bangalore, Srihari S.; Butter, Eric M.; Buchan-Page, Kristin A.; Hurt, Elizabeth A.; Austin, Adrienne B.; Grondhuis, Sabrina N.; Aman, Michael G.

    2014-01-01

    Objective In this study, we aimed to expand on our prior research into the relative efficacy of combining parent training, stimulant medication and placebo (Basic) versus parent training, stimulant, and risperidone (Augmented) therapy by examining treatment effects for attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD) symptoms and peer aggression, symptom-induced—impairment, and informant discrepancy. Method Children (6-12 years; N=168) with severe physical aggression, ADHD, and co-occurring ODD/CD received an open trial of parent training and stimulant medication for 3 weeks. Participants failing to show optimal clinical response were randomly assigned to Basic or Augmented therapy for an additional 6 weeks. Results Compared with Basic therapy, children receiving Augmented therapy experienced greater reduction in parent-rated ODD severity (p=.02, Cohen's d=0.27) and peer aggression (p=.02, Cohen's d=0.32), but not ADHD or CD symptoms. Fewer children receiving Augmented (16%) than Basic (40%) therapy were rated by their parents as impaired by ODD symptoms at Week 9/endpoint (p=.008). Teacher ratings indicated greater reduction in ADHD severity (p=.02, Cohen's d =0.61) with Augmented therapy, but not for ODD or CD symptoms or peer aggression. Although both interventions were associated with marked symptom reduction, a relatively large percentage of children were rated impaired for at least one targeted disorder at Week 9/endpoint by parents (Basic 47%; Augmented 27%) and teachers (Basic 48%; Augmented 38%). Conclusion Augmented was superior to Basic therapy in reducing severity of ADHD and ODD symptoms, peer aggression, and symptom-induced impairment, but clinical improvement was generally context-specific, and effect sizes ranged from small to moderate. PMID:25151418

  16. Interruption of antiretroviral therapy is associated with increased plasma cystatin C.

    PubMed

    Mocroft, Amanda; Wyatt, Christina; Szczech, Lynda; Neuhaus, Jacquie; El-Sadr, Wafaa; Tracy, Russell; Kuller, Lewis; Shlipak, Michael; Angus, Brian; Klinker, Harting; Ross, Michael

    2009-01-02

    Cystatin C has been proposed as an alternative marker of renal function. We sought to determine whether participants randomized to episodic use of antiretroviral therapy guided by CD4 cell count (drug conservation) had altered cystatin C levels compared with those randomized to continuous antiretroviral therapy (viral suppression) in the Strategies for Management of Antiretroviral Therapy trial, and to identify factors associated with increased cystatin C. Cystatin C was measured in plasma collected at randomization, 1, 2, 4, 8 and 12 months after randomization in a random sample of 249 and 250 participants in the drug conservation and viral suppression groups, respectively. Logistic regression was used to model the odds of at least 0.15 mg/dl increase in cystatin C (1 SD) in the first month after randomization, adjusting for demographic and clinical characteristics. At randomization, mean (SD) cystatin C level was 0.99 (0.26 mg/dl) and 1.01 (0.28 mg/dl) in the drug conservation and viral suppression arms, respectively (P = 0.29). In the first month after randomization, 21.8 and 10.6% had at least 0.15 mg/dl increase in cystatin C in the drug conservation and viral suppression arms, respectively (P = 0.0008). The difference in cystatin C between the treatment arms was maintained through 1 year after randomization. After adjustment, participants in the viral suppression arm had significantly reduced odds of at least 0.15 mg/dl increase in cystatin C in the first month (odds ratio 0.42; 95% confidence interval 0.23-0.74, P = 0.0023). These results demonstrate that interruption of antiretroviral therapy is associated with an increase in cystatin C, which may reflect worsened renal function.

  17. Re-Examining the Association between Vitamin D and Childhood Caries

    PubMed Central

    Dudding, Tom; Thomas, Steve J.; Duncan, Karen; Lawlor, Debbie A.; Timpson, Nicholas J.

    2015-01-01

    Background Previous studies have reported an inverse association between vitamin D and childhood dental caries, but whether this is causal is unclear. Objective To determine the causal effect of circulating 25-hydroxyvitamin D concentration on dental caries experience, early caries onset and the requirement for a dental general anesthetic. Design A Mendelian randomization study was undertaken, using genetic variants known to be associated with circulating 25-hydroxyvitamin D concentrations in 5,545 European origin children from the South West of England. Data on caries and related characteristics were obtained from parental and child completed questionnaires between 38 and 91 months and clinical assessments in a random 10% sample at 31, 44 and 61 months. Results In multivariable confounder adjusted analyses no strong evidence for an association of 25-hydroxyvitamin D with caries experience or severity was found but there was evidence for an association with early caries onset, or having a general anesthetic for dental problems. In Mendelian randomization analysis the odds ratio for caries experience per 10 nmol/L increase in 25-hydroxyvitamin D was 0.93 (95% confidence interval: 0.83, 1.05; P = 0.26) and the odds ratio for dental general anaesthetic per 10 nmol/L increase in 25-hydroxyvitamin D was 0.96 (95% confidence interval: 0.75, 1.22; P = 0.72). Conclusions This Mendelian randomization study provides little evidence to support an inverse causal effect of 25-hydroxyvitamin D on dental caries. However, the estimates are imprecise and a larger study is required to refine these analyses. PMID:26692013

  18. Systematic review and network meta-analysis of tedizolid for the treatment of acute bacterial skin and skin structure infections caused by MRSA.

    PubMed

    McCool, Rachael; Gould, Ian M; Eales, Jacqui; Barata, Teresa; Arber, Mick; Fleetwood, Kelly; Glanville, Julie; Kauf, Teresa L

    2017-01-07

    Tedizolid, the active moiety of tedizolid phosphate, is approved in the United States, the European Union, Canada and a number of other countries for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). This network meta-analysis (NMA) evaluates the comparative effectiveness of tedizolid and other antibacterials indicated for the treatment of ABSSSI caused by MRSA. Systematic review of 10 databases was undertaken to inform an NMA to estimate the relative effectiveness of tedizolid and established monotherapy comparators (ceftaroline, daptomycin, linezolid, teicoplanin, tigecycline, vancomycin) for treating MRSA-associated ABSSSI. Randomized controlled trials enrolling adults with ABSSSI or complicated skin and skin structure infections caused by suspected/documented MRSA were eligible for inclusion. Networks were developed based on similarity of study design, patient characteristics, outcome measures and available data. Outcomes of interest included clinical response at end of therapy (EOT), post-therapy evaluation (PTE) or test-of-cure assessment and treatment discontinuations resulting from adverse events (AEs). Bayesian NMA was conducted for each outcome using fixed-effects and random effects models. Literature searches identified 3,618 records; 15 trials met the inclusion criteria and were considered suitable for NMA comparison. In fixed-effects models, tedizolid had higher odds of clinical response at EOT (odds ratio [OR], 1.7; credible interval, 1.0, 3.0) and PTE than vancomycin (OR, 1.6; credible interval, 1.1, 2.5). No differences in odds of clinical response at EOT or PTE were observed between tedizolid and other comparators. There was no evidence of a difference among treatments for discontinuation due to AEs. Results from random effects and fixed-effects models were generally consistent. Tedizolid was superior to vancomycin for clinical response at EOT and PTE. There was no evidence of a difference between tedizolid and other comparators and no evidence of a difference between tedizolid and all comparators when evaluating discontinuation due to AEs. These findings suggest that tedizolid provides an alternative option for the management of serious skin infections caused by suspected or documented MRSA. This study is subject to the limitations inherent in all NMAs, and the results should be interpreted accordingly.

  19. Prevalence of Risk for Type 2 Diabetes in School Children

    ERIC Educational Resources Information Center

    Urrutia-Rojas, Ximena; Menchaca, John

    2006-01-01

    According to the Centers for Disease Control and Prevention, 1 in 3 children born in 2000 in the United States will become diabetic. The odds are higher for African American and Hispanic children as nearly 50% of them will develop diabetes. Random screening is not effective in identifying children at risk for type 2 diabetes mellitus (T2DM);…

  20. A systematic review of dydrogesterone for the treatment of threatened miscarriage

    PubMed Central

    2012-01-01

    The objective of this systematic review was to assess whether the orally acting progestagen, dydrogesterone lowers the incidence of miscarriage in women with threatened miscarriage. A computerized search was performed in Medline, Embase, and Ovid Medline for original reports with the product name ‘Duphaston’ or ‘dydrogesterone’, and limited to clinical human data. Twenty-one reports of dydrogesterone treatment were identified with 1380 patients. Five randomized trials were identified, including 660 women who fulfilled the criteria for metaanalysis. The number of subsequent miscarriages or continuing pregnancies per randomized woman was compared in women receiving dydrogesterone compared to standard bed rest or placebo intervention. There was a 13% (44/335) miscarriage rate after dydrogesterone administration compared to 24% in control women [odds ratio for miscarriage 0.47, (CI = 0.31–0.7), 11% absolute reduction in the miscarriage rate]. The adverse and side effects were summarized in all 21 reports, and seemed to be minimal. Although all the predictive and confounding factors could not be controlled for, the results of this systematic review show a significant reduction of 47% in the odds for miscarriage when dydrogesterone is compared to standard care indicating a real treatment effect. PMID:22794306

  1. The effect of small solar powered 'Bͻkͻͻ' net fans on mosquito net use: results from a randomized controlled cross-over trial in southern Ghana.

    PubMed

    Briët, Olivier J T; Yukich, Joshua O; Pfeiffer, Constanze; Miller, William; Jaeger, Mulako S; Khanna, Nitin; Oppong, Samuel; Nardini, Peter; Ahorlu, Collins K; Keating, Joseph

    2017-01-03

    Long-lasting insecticidal nets (LLINs) are ineffective malaria transmission prevention tools if they are unused. Discomfort due to heat is the most commonly reported reason for not using nets, but this problem is largely unaddressed. With increasing rural electrification and the dropping price of solar power, fans could improve comfort inside nets and be affordable to populations in malaria endemic areas. Here, results are presented from a pilot randomized controlled cross-over study testing the effect of fans on LLIN use. Eighty-three households from two rural communities in Greater Accra, Ghana, randomized into three groups, participated in a 10-month cross-over trial. After a screening survey to identify eligible households, all households received new LLINs. Bͻkͻͻ net fan systems (one fan per member) were given to households in Group 1 and water filters were given to households in Group 2. At mid-point, Group 1 and 2 crossed over interventions. Households in Group 1 and 2 participated in fortnightly surveys on households' practices related to nets, fans and water filters, while households in Group 3 were surveyed only at screening, mid-point and study end. Entomological and weather data were collected throughout the study. Analysis took both 'per protocol' (PP) and 'intention to treat' (ITT) approaches. The mid- and end-point survey data from Group 1 and 2 were analysed using Firth logistic regressions. Fortnightly survey data from all groups were analysed using logistic regressions with random effects. Provision of fans to households appeared to increase net use in this study. Although the increase in net use explained by fans was not significant in the primary analyses (ITT odds ratio 3.24, p > 0.01; PP odds ratio = 1.17, p > 0.01), it was significant in secondary PP analysis (odds ratio = 1.95, p < 0.01). Net use was high at screening and even higher after provision of new LLINs and with follow up. Fan use was 90-100% depending on the fortnightly visit. This pilot study could not provide definitive evidence that fans increase net use. A larger study with additional statistical power is needed to assess this association across communities with diverse environmental and socio-demographic characteristics.

  2. The Impact of a Randomized Sleep Education Intervention for College Students.

    PubMed

    Hershner, Shelley; O'Brien, Louise M

    2018-03-15

    Sleep deprivation can impair attention, mood, and performance; however, few effective sleep education programs are available. The aim of this study was to assess the effect of a sleep education website, Sleep to Stay Awake (sleeptostayawake.org), on sleep behaviors of college students. College students (age 18 years or older) attending a public Midwestern university were randomized to control or intervention groups. All subjects completed baseline surveys that included demographics, Pittsburgh Sleep Quality Index, Patient Health Questionnaire, sleep knowledge, and measures of sleepiness and circadian rhythm. The intervention group then undertook the online intervention. Surveys were repeated at 1 week and at 8 weeks. Students who participated included 295 controls and 254 intervention subjects. The mean age was 21.9 ± 4.1 years and 41.7% were male. Survey results at 8 weeks showed that more intervention subjects reported improved sleep behaviors (50.3% versus 39.5%, P = .04). Intervention subjects were more likely to stop electronics use earlier (odds ratio [95% confidence interval] = 1.5 [1.0-2.4]), keep a more regular sleep schedule (1.6 [1.06-2.4]), have an earlier weekday rise time (2.4 [1.3-4.4]), and have a lower likelihood of insufficient sleep prior to examinations (0.46 [0.28-0.76]). The intervention group had improvement in mean sleep quality (odds ratio = 5.8 versus 6.6, P < .001) and depression scores (odds ratio = 4.6 versus 5.6, P = .03). No significant differences were found in the other measures. A brief and personalized online sleep education intervention improved sleep behaviors, sleep quality, and depressions scores. This novel approach to address sleep deprivation, poor sleep habits, and mood among college students may offer an effective and inexpensive remedy. © 2018 American Academy of Sleep Medicine.

  3. Children's gender and parents' color preferences.

    PubMed

    Cohen, Philip N

    2013-04-01

    Gender differences in color preferences have been found in adults and children, but they remain unexplained. This study asks whether the gendered social environment in adulthood affects parents' color preferences. The analysis used the gender of children to represent one aspect of the gendered social environment. Because having male versus female children in the U.S. is generally randomly distributed, it provides something of a natural experiment, offering evidence about the social construction of gender in adulthood. The participants were 749 adults with children who responded to an online survey invitation, asking "What's your favorite color?" Men were more likely to prefer blue, while women were more likely to prefer red, purple, and pink, consistent with long-standing U.S. patterns. The effect of having only sons was to widen the existing gender differences between men and women, increasing the odds that men prefer blue while reducing the odds that women do; and a marginally significant effect showed women having higher odds of preferring pink when they have sons only. The results suggest that, in addition to any genetic, biological or child-socialization effects shaping adults' tendency to segregate their color preferences by gender, the gender context of adulthood matters as well.

  4. QT-interval effects of methadone, levomethadyl, and buprenorphine in a randomized trial.

    PubMed

    Wedam, Erich F; Bigelow, George E; Johnson, Rolley E; Nuzzo, Paul A; Haigney, Mark C P

    2007-12-10

    Levomethadyl acetate, methadone hydrochloride, and buprenorphine hydrochloride are equally effective treatments for opioid dependence. Each blocks the human ether-a-go-go-related gene (hERG)-associated channel in vitro and represents a risk for QT prolongation. To compare the effects of 3 known hERG-associated channel blockers on the corrected QT (QTc), we conducted a randomized, controlled trial of opioid-addicted subjects. We analyzed 12-lead electrocardiograms collected at baseline and every 4 weeks from 165 opioid-addicted participants in a 17-week randomized double-blind clinical trial of equally effective doses of levomethadyl, methadone, and buprenorphine at a major referral center. Analyses were limited to the 154 patients with a normal baseline QTc = (QT/ radical R-R) who had at least 1 subsequent in-treatment electrocardiogram. Patients were randomized to receive treatment with levomethadyl, methadone, or buprenorphine (hereinafter, levomethadyl, methadone, and buprenorphine groups, respectively). The prespecified end points were a QTc greater than 470 milliseconds in men (or >490 milliseconds in women), or an increase from baseline in QTc greater than 60 milliseconds. Baseline QTc was similar in the 3 groups. The levomethadyl and methadone groups were significantly more likely to manifest a QTc greater than 470 or 490 milliseconds (28% for the levomethadyl group vs 23% for the methadone group vs 0% for the buprenorphine group; P < .001) or an increase from baseline in QTc greater than 60 milliseconds (21% of the levomethadyl group [odds ratio, 15.8; 95% confidence interval, 3.7-67.1] and 12% of the methadone group [odds ratio, 8.4; 95% confidence interval, 1.9-36.4]) compared with the buprenorphine group (2% of subjects; P < .001). In subjects whose dosage of levomethadyl or methadone remained fixed over at least 8 weeks, the QTc continued to increase progressively over time (P = .08 for the levomethadyl group, P = .01 for the methadone group). Buprenorphine is associated with less QTc prolongation than levomethadyl or methadone and may be a safe alternative.

  5. Meta-analysis of randomized controlled trials on risk of myocardial infarction from the use of oral direct thrombin inhibitors.

    PubMed

    Artang, Ramin; Rome, Eric; Nielsen, Jørn Dalsgaard; Vidaillet, Humberto J

    2013-12-15

    Dabigatran has been associated with greater risk of myocardial infarction (MI) than warfarin. It is unknown whether the increased risk is unique to dabigatran, an adverse effect shared by other oral direct thrombin inhibitors (DTIs), or the result of a protective effect of warfarin against MI. To address these questions, we systematically searched MEDLINE and performed a meta-analysis on randomized trials that compared oral DTIs with warfarin for any indication with end point of MIs after randomization. We furthermore performed a secondary meta-analysis on atrial fibrillation stroke prevention trials with alternative anticoagulants compared with warfarin with end point of MIs after randomization. A total of 11 trials (39,357 patients) that compared warfarin to DTIs (dabigatran, ximelagatran, and AZD0837) were identified. In these trials, patients treated with oral DTIs were more likely to experience an MI than their counterparts treated with warfarin (285 of 23,333 vs 133 of 16,024, odds ratio 1.35, 95% confidence interval 1.10 to 1.66, p = 0.005). For secondary analysis, 8 studies (69,615 patients) were identified that compared warfarin with alternative anticoagulant including factor Xa inhibitors, DTIs, aspirin, and clopidogrel. There was no significant advantage in the rate of MIs with the use of warfarin versus comparators (odds ratio 1.06, 95% confidence interval 0.85 to 1.34, p = 0.59). In conclusion, our data suggest that oral DTIs were associated with increased risk of MI. This increased risk appears to be a class effect of these agents, not a specific phenomenon unique to dabigatran or protective effect of warfarin. These findings support the need for enhanced postmarket surveillance of oral DTIs and other novel agents. Copyright © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  6. A multilevel analysis of the effect of Malawi’s Social Cash Transfer Pilot Scheme on school-age children’s health

    PubMed Central

    Luseno, Winnie K; Singh, Kavita; Handa, Sudhanshu; Suchindran, Chirayath

    2014-01-01

    Objective The primary goal was to examine whether Malawi Social Cash Transfer Pilot Scheme, initially implemented in a rural district in central Malawi, improved health outcomes for children aged 6–17. Secondary goals were to examine the effects of individual child- (orphan status and gender) and household-level factors (number of working-age adults and sick adults) on health outcomes. Another secondary goal was to examine whether orphan status modified the cash transfer effect on health outcomes. Methods This multilevel study used panel data collected in 2007–08 from a randomized controlled evaluation study of phase one of the programme. The analyses included 1197 children aged 6–17 in 486 households. The four outcomes of interest were: illness in the past month, illness that stopped normal activities in the past month, missing school due to illness or injury in the past month and health care use for worst illness in the past year. Findings Approximately two-thirds of children in cash transfer eligible households were orphans. Compared with children in non-beneficiary households, those in beneficiary households had a 37% lower odds of child illness (P < 0.05), 42% lower odds of illness that stopped normal activities (P < 0.01) and substantially higher odds of utilizing health services for a serious illness (odds ratio = 10.98; P < 0.01). An increase in the household number of working-age adults was associated with 34% lower odds of child illness (P < 0.01). An increase in the household number of sick adults increased the odds of child illness by 97% (P < 0.01) and serious illness by 49% (P < 0.01). No statistically significant differences were observed by orphan status and child’s gender. Consistent differential programme effects by orphan status were not observed. Conclusion Unconditional cash transfer programmes to poor households have the potential to improve health outcomes for all vulnerable children aged 6–17. PMID:23661614

  7. Effect of aspirin in pregnant women is dependent on increase in bleeding time.

    PubMed

    Dumont, A; Flahault, A; Beaufils, M; Verdy, E; Uzan, S

    1999-01-01

    Randomized trials with low-dose aspirin to prevent preeclampsia and intrauterine growth restriction have yielded conflicting results. In particular, 3 recent large trials were not conclusive. Study designs, however, varied greatly regarding selection of patients, dose of aspirin, and timing of treatment, all of which can be determinants of the results. Retrospectively analyzing the conditions associated with failure or success of aspirin may therefore help to draw up new hypotheses and prepare for more specific randomized trials. We studied a historical cohort of 187 pregnant women who were considered at high risk for preeclampsia, intrauterine growth restriction, or both and were therefore treated with low-dose aspirin between 1989 and 1994. Various epidemiologic, clinical, and laboratory data were extracted from the files. Univariate and multivariate analyses were performed to search for independent parameters associated with the outcome of pregnancy. Age, parity, weight, height, and race had no influence on the outcome. The success rate was higher when treatment was given because of previous poor pregnancy outcomes than when it was given for other indications, and the patients with successful therapy had started aspirin earlier than had those with therapy failure (17.7 vs 20.0 weeks' gestation, P =.04). After multivariate analysis an increase in Ivy bleeding time after 10 days of treatment by >2 minutes was an independent predictor of a better outcome (odds ratio 0.22, 95% confidence interval 0.09-0.51). Borderline statistical significance was observed for aspirin initiation before 17 weeks' gestation (odds ratio 0.44, 95% confidence interval 0.18-1. 08). Abnormal uterine artery Doppler velocimetric scan at 20-24 weeks' gestation (odds ratio 3.31, 95% confidence interval 1.41-7.7), abnormal umbilical artery Doppler velocimetric scan after 26 weeks' gestation (odds ratio 37.6, 95% confidence interval 3.96-357), and use of antihypertensive therapy (odds ratio 6.06, 95% confidence interval 2.45-15) were independent predictors of poor outcome. Efficacy of aspirin seems optimal when bleeding time increases >/=2 minutes with treatment, indicating a more powerful antiplatelet effect. This suggests that the dose of aspirin should be adjusted according to a biologic marker of the antiplatelet effect. A prospective trial is warranted to test this hypothesis.

  8. Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial

    PubMed Central

    Mao, Jun J.; Xie, Sharon X.; Zee, Jarcy; Soeller, Irene; Li, Qing S.; Rockwell, Kenneth; Amsterdam, Jay D.

    2015-01-01

    Background We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder. Hypothesis We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events. Study Design Phase II randomized placebo controlled clinical trial Methods 57 subjects were randomized to 12 weeks of standardized R. rosea extract, sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models. Results Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p=0.79, p=0.28, and p=0.17, respectively). The decline in HAM-D scores was greater for sertraline (−8.2, 95% confidence interval [CI], −12.7 to −3.6) versus R. rosea (−5.1, 95% CI: −8.8 to −1.3) and placebo (−4.6, 95% CI: −8.6 to −0.6). While the odds of improving (versus placebo) were greater for sertraline (1.90 [0.44–8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38–5.04]), more subjects on sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p=0.012). Conclusions Although R. rosea produced less antidepressant effect versus sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression. PMID:25837277

  9. Effect of Patient Navigation on Breast Cancer Screening Among African American Medicare Beneficiaries: A Randomized Controlled Trial.

    PubMed

    Marshall, Jessie Kimbrough; Mbah, Olive M; Ford, Jean G; Phelan-Emrick, Darcy; Ahmed, Saifuddin; Bone, Lee; Wenzel, Jennifer; Shapiro, Gary R; Howerton, Mollie; Johnson, Lawrence; Brown, Qiana; Ewing, Altovise; Pollack, Craig Evan

    2016-01-01

    There is growing evidence that patient navigation improves breast cancer screening rates; however, there are limited efficacy studies of its effect among African American older adult women. To evaluate the effect of patient navigation on screening mammography among African American female Medicare beneficiaries in Baltimore, MD. The Cancer Prevention and Treatment Demonstration (CPTD), a multi-site study, was a randomized controlled trial conducted from April 2006 through December 2010. Community-based and clinical setting. The CPTD Screening Trial enrolled 1905 community-dwelling African American female Medicare beneficiaries who were ≥65 years of age and resided in Baltimore, MD. Participants were recruited from health clinics, community centers, health fairs, mailings using Medicare rosters, and phone calls. Participants were randomized to either: printed educational materials on cancer screening (control group) or printed educational materials + patient navigation services designed to help participants overcome barriers to cancer screening (intervention group). Self-reported receipt of mammography screening within 2 years of the end of the study. The median follow-up period for participants in this analysis was 17.8 months. In weighted multivariable logistic regression analyses, women in the intervention group had significantly higher odds of being up to date on mammography screening at the end of the follow-up period compared to women in the control group (odds ratio [OR] 2.26, 95 % confidence interval [CI]1.59-3.22). The effect of the intervention was stronger among women who were not up to date with mammography screening at enrollment (OR 3.63, 95 % CI 2.09-6.38). Patient navigation among urban African American Medicare beneficiaries increased self-reported mammography utilization. The results suggest that patient navigation for mammography screening should focus on women who are not up to date on their screening.

  10. Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

    PubMed Central

    Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

    2008-01-01

    BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

  11. Lay health educators increase colorectal cancer screening among Hmong Americans: A cluster randomized controlled trial.

    PubMed

    Tong, Elisa K; Nguyen, Tung T; Lo, Penny; Stewart, Susan L; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Kagawa-Singer, Marjorie L; Sy, Angela U; Cuaresma, Charlene; Lam, Hy T; Wong, Ching; Tran, Mi T; Chen, Moon S

    2017-01-01

    Asian Americans have lower colorectal cancer (CRC) screening rates than non-Hispanic white individuals. Hmong Americans have limited socioeconomic resources and literacy. The current randomized controlled trial was conducted to determine whether bilingual/bicultural lay health educator (LHE) education could increase CRC screening among Hmong Americans. A cluster randomized controlled trial was conducted among Hmong Americans in Sacramento, California. LHEs and recruited participants were randomized to intervention or control groups. The intervention group received CRC education over 3 months delivered by an LHE. The control group received education regarding nutrition and physical activity delivered by a health educator. The outcomes were changes in self-reported ever-screening and up-to-date CRC screening after 6 months. All 329 participants were foreign-born with mostly no formal education, limited English proficiency, and no employment. The majority of the participants were insured and had a regular source of health care. The intervention group experienced greater changes after the intervention than the control group for ever-screening (P = .068) and being up-to-date with screening (P<.0001). In multivariable regression analyses, the intervention group demonstrated a greater increase than the control group in reporting ever-screening (adjusted odds ratio, 1.73; 95% confidence interval, 1.07-2.79) and being up-to-date with screening (adjusted odds ratio, 1.71; 95% confidence interval, 1.26-2.32). Individuals who had health insurance were found to have >4 times the odds of receiving screening, both ever-screening and up-to-date screening. A higher CRC knowledge score mediated the intervention effect for both screening outcomes. A culturally and linguistically appropriate educational intervention delivered by trained LHEs was found to increase CRC screening in an immigrant population with low levels of education, employment, English proficiency, and literacy. Cancer 2017;98-106. © 2016 American Cancer Society. © 2016 American Cancer Society.

  12. Computerized counseling reduces HIV-1 viral load and sexual transmission risk: findings from a randomized controlled trial.

    PubMed

    Kurth, Ann E; Spielberg, Freya; Cleland, Charles M; Lambdin, Barrot; Bangsberg, David R; Frick, Pamela A; Severynen, Anneleen O; Clausen, Marc; Norman, Robert G; Lockhart, David; Simoni, Jane M; Holmes, King K

    2014-04-15

    Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. Longitudinal randomized controlled trial. An academic HIV clinic and a community-based organization in Seattle. In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention). Randomization to computerized counseling or assessment only, 4 sessions over 9 months. HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations. Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038. Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.

  13. Effect of Time Interval Between Tumescent Local Anesthesia Infiltration and Start of Surgery on Operative Field Visibility in Hand Surgery Without Tourniquet.

    PubMed

    Bashir, Muhammad Mustehsan; Qayyum, Rehan; Saleem, Muhammad Hammad; Siddique, Kashif; Khan, Farid Ahmad

    2015-08-01

    To determine the optimal time interval between tumescent local anesthesia infiltration and the start of hand surgery without a tourniquet for improved operative field visibility. Patients aged 16 to 60 years who needed contracture release and tendon repair in the hand were enrolled from the outpatient clinic. Patients were randomized to 10-, 15-, or 25-minute intervals between tumescent anesthetic solution infiltration (0.18% lidocaine and 1:221,000 epinephrine) and the start of surgery. The end point of tumescence anesthetic infiltration was pale and firm skin. The surgical team was blinded to the time of anesthetic infiltration. At the completion of the procedure, the surgeon and the first assistant rated the operative field visibility as excellent, fair, or poor. We used logistic regression models without and with adjustment for confounding variables. Of the 75 patients enrolled in the study, 59 (79%) were males, 7 were randomized to 10-minute time intervals (further randomization was stopped after interim analysis found consistently poor operative field visibility), and 34 were randomized to the each of the 15- and 25-minute groups. Patients who were randomized to the 25-minute delay group had 29 times higher odds of having an excellent operative visual field than those randomized to the 15-minute delay group. After adjusting for age, sex, amount of tumescent solution infiltration, and duration of operation, the odds ratio remained highly significant. We found that an interval of 25 minutes provides vastly superior operative field visibility; 10-minute delay had the poorest results. Therapeutic I. Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  14. The effect of emotion and physician communication behaviors on surrogates' life-sustaining treatment decisions: a randomized simulation experiment.

    PubMed

    Barnato, Amber E; Arnold, Robert M

    2013-07-01

    Surrogate decision makers for critically ill patients experience strong negative emotional states. Emotions influence risk perception, risk preferences, and decision making. We sought to explore the effect of emotional state and physician communication behaviors on surrogates' life-sustaining treatment decisions. 5 × 2 between-subject randomized factorial experiment. Web-based simulated interactive video meeting with an intensivist to discuss code status. Community-based participants 35 and older who self-identified as the surrogate for a parent or spouse recruited from eight U.S. cities through public advertisements. Block random assignment to emotion arousal manipulation and each of the four physician communication behaviors. Surrogate's code status decision (cardiopulmonary resuscitation vs do not resuscitate/allow natural death). Two hundred fifty-six of 373 respondents (69%) logged-in and were randomized: average age was 50; 70% were surrogates for a parent; 63.5% were women; 76% were white, 11% black, and 9% Asian; and 81% were college educated. When asked about code status, 56% chose cardiopulmonary resuscitation. The emotion arousal manipulation increased the score on depression-dejection scale (β = 1.76 [0.58 - 2.94]) but did not influence cardiopulmonary resuscitation choice. Physician attending to emotion and framing the decision as the patient's rather than the surrogate's did not influence cardiopulmonary resuscitation choice. Framing no cardiopulmonary resuscitation as the norm rather than cardiopulmonary resuscitation resulted in fewer surrogates choosing cardiopulmonary resuscitation (48% vs 64%, odds ratio, 0.52 [95% CI, 0.32-0.87]), as did framing the alternative to cardiopulmonary resuscitation as "allow natural death" rather than do not resuscitate (49% vs 61%, odds ratio, 0.58 [95% CI, 0.35-0.96]). Experimentally induced emotional state did not influence code status decisions, although small changes in physician communication behaviors substantially influenced this decision.

  15. Water administration and the risk of syncope and pre-syncope during blood donation: a randomized clinical trial

    PubMed Central

    van den Berg, Karin; Lam, Jameson; Bruhn, Roberta; Custer, Brian; Murphy, Edward L

    2012-01-01

    Background Blood centers rely heavily upon adolescent donors to meet blood demand, but pre-syncope and syncope are more frequent in younger donors. Studies have suggested administration of water prior to donation may reduce syncope and/or pre-syncope in this group. Study design and methods We conducted a randomized, controlled trial to establish the effect of pre-loading with 500ml of water on the rate of syncope and pre-syncope in adolescent donors. School collection sites in Eastern Cape Province of South Africa were randomized to receive water or not. Incidence of syncope and pre-syncope was compared between randomization groups using multivariable logistic regression. Results Of 2,464 study participants, 1,337 received water and 1,127 did not; groups differed slightly by gender and race. Syncope or pre-syncope was seen in 23 (1.7%) of the treatment and 18 (1.6%) of the control arm subjects. After adjusting for race, gender, age and donation history, there was no difference in outcome between the water versus no water arms (adjusted odds ratio (OR) = 0.80 (95% CI 0.42–1.53). Black donors had 7-fold lower odds of syncope or pre-syncope than their white counterparts (adjusted OR 0.14, 95% CI 0.04–0.47). Conclusion Preloading adolescent donors with 500ml of water did not have a major effect in reducing syncope and pre-syncope in South African adolescent donors. Our adolescent donors had a lower overall syncope and pre-syncope rate than similar populations in the USA, limiting the statistical power of the study. We confirmed much lower rates of syncope and pre-syncope among young Black donors. PMID:22486209

  16. Generalized ruin problems and asynchronous random walks

    NASA Astrophysics Data System (ADS)

    Abad, E.

    2005-07-01

    We consider a gambling game with two different kinds of trials and compute the duration of the game (averaged over all possible initial capitals of the players) by a mapping of the problem to a 1D lattice walk of two particles reacting upon encounter. The relative frequency of the trials is governed by the synchronicity parameter p of the random walk. The duration of the game is given by the mean time to reaction, which turns out to display a different behavior for even and odd lattices, i.e. this quantity is monotonic in p for odd lattices and non-monotonic for even lattices. In the game picture, this implies that the players minimize the duration of the game by restricting themselves to one type of trial if their joint capital is odd, otherwise a non-symmetric mixture of both trials is needed.

  17. Adolescent Pregnancy Prevention Among Youths Living in Group Care Homes: A Cluster Randomized Controlled Trial

    PubMed Central

    Vesely, Sara K.; Green, Jennifer; Clements-Nolle, Kristen; Lu, Minggen

    2018-01-01

    Objectives. To determine if the Power Through Choices (PTC) intervention can increase the use of birth control and reduce pregnancy among system-involved youths living in group care homes. Methods. We performed a 2-arm cluster randomized controlled trial involving group care homes operated by child welfare or juvenile justice systems in California, Maryland, and Oklahoma with assessments immediately before and after the intervention, and at 6- and 12-month follow-up. We collected data from 2012 to 2014 via self-administered questionnaires. Participants (n = 1036) were young (mean age = 16.1 years), predominantly male (79%), racially/ethnically diverse (37% Hispanic, 20% Black, 21% White, 17% multiracial), and sexually experienced (88%). Results. At 6-month follow-up, participants in the intervention group had significantly lower odds of having recent sexual intercourse without using birth control (adjusted odds ratio [AOR] = 0.72; 95% confidence interval [CI] = 0.52, 0.98). At 12-month follow-up assessment, participants in the intervention group had significantly lower odds of ever being pregnant or getting someone pregnant (AOR = 0.67; 95% CI = 0.46, 0.99). Conclusions. The results suggest that PTC is an effective sexual health education intervention that can be implemented with system-involved youths who represent a sexually experienced multiracial youth population. PMID:29443557

  18. A Prospective, Randomized Trial of Routine Duplex Ultrasound Surveillance on Arteriovenous Fistula Maturation.

    PubMed

    Han, Ahram; Min, Seung-Kee; Kim, Mi-Sook; Joo, Kwon Wook; Kim, Jungsun; Ha, Jongwon; Lee, Joongyub; Min, Sang-Il

    2016-10-07

    Use of arteriovenous fistulas, the most preferred type of access for hemodialysis, is limited by their high maturation failure rate. The aim of this study was to assess whether aggressive surveillance with routine duplex ultrasound and intervention can decrease the maturation failure rate of arteriovenous fistulas. We conducted a single-center, parallel-group, randomized, controlled trial of patients undergoing autogenous arteriovenous fistula. Patients were randomly assigned (1:1) to either the routine duplex or selective duplex group. In the routine duplex group, duplex ultrasound and physical examination were performed 2, 4, and 8 weeks postoperatively. In the selective duplex group, duplex examination was performed only when physical examination detected an abnormality. The primary end point was the maturation failure rate 8 weeks after fistula creation. Maturation failure was defined as the inability to achieve clinical maturation ( i.e. , a successful first use) and failure to achieve sonographic maturation (fistula flow >500 ml/min and diameter >6 mm) within 8 weeks. Between June 14, 2012, and June 25, 2014, 150 patients were enrolled (75 patients in each group), and 118 of those were included in the final analysis. The maturation failure rate was lower in the routine duplex group (8 of 59; 13.6%) than in the selective duplex group (15 of 59; 25.4%), but the difference was not statistically significant (odds ratio, 0.46; 95% confidence interval, 0.18 to 1.19; P =0.10). Factors associated with maturation failure were women (odds ratio, 3.84; 95% confidence interval, 1.05 to 14.06; P =0.04), coronary artery disease (odds ratio, 6.36; 95% confidence interval, 1.62 to 24.95; P <0.01), diabetes (odds ratio, 6.10; 95% confidence interval, 1.76 to 21.19; P <0.01), and the preoperative cephalic vein diameter (odds ratio, 0.30; 95% confidence interval, 0.13 to 0.71; P <0.01). Postoperative routine duplex surveillance failed to prove superiority compared with selective duplex after physical examination for reducing arteriovenous fistula maturation failure. However, the wide 95% confidence interval for the effect of intervention precludes a firm conclusion that routine duplex surveillance was not beneficial. Copyright © 2016 by the American Society of Nephrology.

  19. Changes in respiratory and non-respiratory symptoms in occupants of a large office building over a period of moisture damage remediation attempts.

    PubMed

    Park, Ju-Hyeong; Cho, Sook Ja; White, Sandra K; Cox-Ganser, Jean M

    2018-01-01

    There is limited information on the natural history of building occupants' health in relation to attempts to remediate moisture damage. We examined changes in respiratory and non-respiratory symptoms in 1,175 office building occupants over seven years with multiple remediation attempts. During each of four surveys, we categorized participants using a severity score: 0 = asymptomatic; 1 = mild, symptomatic in the last 12 months, but not frequently in the last 4 weeks; 2 = severe, symptomatic at least once weekly in the last 4 weeks. Building-related symptoms were defined as improving away from the building. We used random intercept models adjusted for demographics, smoking, building tenure, and microbial exposures to estimate temporal changes in the odds of building-related symptoms or severity scores independent of the effect of microbial exposures. Trend analyses of combined mild/severe symptoms showed no changes in the odds of respiratory symptoms but significant improvement in non-respiratory symptoms over time. Separate analyses showed increases in the odds of severe respiratory symptoms (odds ratio/year = 1.15‒1.16, p-values<0.05) and severity scores (0.02/year, p-values<0.05) for wheezing and shortness of breath on exertion, due to worsening of participants in the mild symptom group. For non-respiratory symptoms, we found no changes in the odds of severe symptoms but improvement in severity scores (-0.04‒-0.01/year, p-values<0.05) and the odds for mild fever and chills, excessive fatigue, headache, and throat symptoms (0.65-0.79/year, p-values<0.05). Our study suggests that after the onset of respiratory and severe non-respiratory symptoms associated with dampness/mold, remediation efforts might not be effective in improving occupants' health.

  20. Changes in respiratory and non-respiratory symptoms in occupants of a large office building over a period of moisture damage remediation attempts

    PubMed Central

    Cho, Sook Ja; White, Sandra K.; Cox-Ganser, Jean M.

    2018-01-01

    There is limited information on the natural history of building occupants’ health in relation to attempts to remediate moisture damage. We examined changes in respiratory and non-respiratory symptoms in 1,175 office building occupants over seven years with multiple remediation attempts. During each of four surveys, we categorized participants using a severity score: 0 = asymptomatic; 1 = mild, symptomatic in the last 12 months, but not frequently in the last 4 weeks; 2 = severe, symptomatic at least once weekly in the last 4 weeks. Building-related symptoms were defined as improving away from the building. We used random intercept models adjusted for demographics, smoking, building tenure, and microbial exposures to estimate temporal changes in the odds of building-related symptoms or severity scores independent of the effect of microbial exposures. Trend analyses of combined mild/severe symptoms showed no changes in the odds of respiratory symptoms but significant improvement in non-respiratory symptoms over time. Separate analyses showed increases in the odds of severe respiratory symptoms (odds ratio/year = 1.15‒1.16, p-values<0.05) and severity scores (0.02/year, p-values<0.05) for wheezing and shortness of breath on exertion, due to worsening of participants in the mild symptom group. For non-respiratory symptoms, we found no changes in the odds of severe symptoms but improvement in severity scores (-0.04‒-0.01/year, p-values<0.05) and the odds for mild fever and chills, excessive fatigue, headache, and throat symptoms (0.65–0.79/year, p-values<0.05). Our study suggests that after the onset of respiratory and severe non-respiratory symptoms associated with dampness/mold, remediation efforts might not be effective in improving occupants’ health. PMID:29324816

  1. Inflammatory Biomarkers and Risk of Schizophrenia: A 2-Sample Mendelian Randomization Study.

    PubMed

    Hartwig, Fernando Pires; Borges, Maria Carolina; Horta, Bernardo Lessa; Bowden, Jack; Davey Smith, George

    2017-12-01

    Positive associations between inflammatory biomarkers and risk of psychiatric disorders, including schizophrenia, have been reported in observational studies. However, conventional observational studies are prone to bias, such as reverse causation and residual confounding, thus limiting our understanding of the effect (if any) of inflammatory biomarkers on schizophrenia risk. To evaluate whether inflammatory biomarkers have an effect on the risk of developing schizophrenia. Two-sample mendelian randomization study using genetic variants associated with inflammatory biomarkers as instrumental variables to improve inference. Summary association results from large consortia of candidate gene or genome-wide association studies, including several epidemiologic studies with different designs, were used. Gene-inflammatory biomarker associations were estimated in pooled samples ranging from 1645 to more than 80 000 individuals, while gene-schizophrenia associations were estimated in more than 30 000 cases and more than 45 000 ancestry-matched controls. In most studies included in the consortia, participants were of European ancestry, and the prevalence of men was approximately 50%. All studies were conducted in adults, with a wide age range (18 to 80 years). Genetically elevated circulating levels of C-reactive protein (CRP), interleukin-1 receptor antagonist (IL-1Ra), and soluble interleukin-6 receptor (sIL-6R). Risk of developing schizophrenia. Individuals with schizophrenia or schizoaffective disorders were included as cases. Given that many studies contributed to the analyses, different diagnostic procedures were used. The pooled odds ratio estimate using 18 CRP genetic instruments was 0.90 (random effects 95% CI, 0.84-0.97; P = .005) per 2-fold increment in CRP levels; consistent results were obtained using different mendelian randomization methods and a more conservative set of instruments. The odds ratio for sIL-6R was 1.06 (95% CI, 1.01-1.12; P = .02) per 2-fold increment. Estimates for IL-1Ra were inconsistent among instruments, and pooled estimates were imprecise and centered on the null. Under mendelian randomization assumptions, our findings suggest a protective effect of CRP and a risk-increasing effect of sIL-6R (potentially mediated at least in part by CRP) on schizophrenia risk. It is possible that such effects are a result of increased susceptibility to early life infection.

  2. The effect of a school-based intervention on sunbed use in Danish pupils at continuation schools: a cluster-randomized controlled trial.

    PubMed

    Aarestrup, Cecilie; Bonnesen, Camilla T; Thygesen, Lau C; Krarup, Anne F; Waagstein, Anne B; Jensen, Poul D; Bentzen, Joan

    2014-02-01

    To examine the effect of an educational intervention on sunbed use and intentions and attitudes toward sunbed use in 14- to 18-year-olds at continuation schools. We randomized 33 continuation schools either to receive the educational intervention (n = 16) or to be controls (n = 17). Intervention schools received an e-magazine addressing the health risks of sunbed use. Information on behavior and intentions and attitudes toward sunbed use was gathered through self-administrated questionnaires before the intervention and at 6 months as a follow-up. The effect of the intervention was examined by multilevel linear regression and logistic regression. Sunbed use was significantly lower at follow-up among pupils at intervention schools versus pupils at control schools (girls: odds ratio .60, 95% confidence interval .42-.86; Boys: odds ratio .58, 95% confidence interval .35-.96). The intervention had no effect on intention to use sunbeds or attitudes toward sunbed use. The analyses revealed a significant impact of school on attitudes toward sunbed; the intraclass correlation coefficient was estimated to be 6.0% and 7.8% for girls and boys, respectively. The findings from the present study provide new evidence of a positive effect of an educational intervention on sunbed use among pupils aged 14-18 years at continuation schools. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  3. A randomized controlled trial of dexamethasone as an adjunctive therapy to propylene glycol for treatment of hyperketonemia in postpartum dairy cattle.

    PubMed

    Tatone, Elise H; Duffield, Todd F; Capel, Michael B; DeVries, Trevor J; LeBlanc, Stephen J; Gordon, Jessica L

    2016-11-01

    Treatment of hyperketonemia with oral propylene glycol has proven efficacy but the cure rate remains moderate. Dexamethasone has long been suggested as a treatment for hyperketonemia, even though evidence of its efficacy is contradictory. The objective of this randomized controlled trial was to evaluate the effect of adding a single intramuscular injection of 20mg of dexamethasone to oral propylene glycol therapy for hyperketonemia [blood β-hydroxybutyrate (BHB) ≥1.2mmol/L]. All cows between 3 and 16d in milk on 4 dairy farms in New York State were tested once weekly for hyperketonemia using a handheld ketone meter. All enrolled animals received 312g (300mL) of propylene glycol orally once daily for 4d and either a single injection of dexamethasone or an equivalent volume of sterile saline. A total of 509 animals were enrolled, with 254 and 255 in the placebo and dexamethasone groups, respectively. Treatment with dexamethasone decreased the odds of being hyperketonemic in the second week posttreatment; however, the odds of hyperketonemia in the first week posttreatment only decreased in those animals that were treated at a BHB blood concentration between 1.2 and 1.5mmol/L. For the 8% of cows with blood BHB >3.2mmol/L at enrollment, receiving dexamethasone increased the odds of being hyperketonemic the following week. We detected no difference between treatment groups in the odds of postpartum disease or in milk production. For cows with initial BHB of 1.2 to 1.5mmol/L, treatment with dexamethasone tended to reduce the odds of pregnancy at first insemination. Based on the small and conditional benefits of dexamethasone and a lack of difference in milk yield or disease incidence, we do not recommend the use of dexamethasone to treat hyperketonemia. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  4. E-cigarettes and smoking cessation in real-world and clinical settings: a systematic review and meta-analysis

    PubMed Central

    Kalkhoran, Sara; Glantz, Stanton A

    2016-01-01

    Summary Background Smokers increasingly use e-cigarettes for many reasons, including attempts to quit combustible cigarettes and to use nicotine where smoking is prohibited. We aimed to assess the association between e-cigarette use and cigarette smoking cessation among adult cigarette smokers, irrespective of their motivation for using e-cigarettes. Methods PubMed and Web of Science were searched between April 27, 2015, and June 17, 2015. Data extracted included study location, design, population, definition and prevalence of e-cigarette use, comparison group (if applicable), cigarette consumption, level of nicotine dependence, other confounders, definition of quitting smoking, and odds of quitting smoking. The primary endpoint was cigarette smoking cessation. Odds of smoking cessation among smokers using e-cigarettes compared with smokers not using e-cigarettes were assessed using a random effects meta-analysis. A modification of the ACROBAT-NRSI tool and the Cochrane Risk of Bias Tool were used to assess bias. This meta-analysis is registered with PROSPERO (number CRD42015020382). Findings 38 studies (of 577 studies identified) were included in the systematic review; all 20 studies with control groups (15 cohort studies, three cross-sectional studies, and two clinical trials) were included in random effects meta-analysis and sensitivity analyses. Odds of quitting cigarettes were 28% lower in those who used e-cigarettes compared with those who did not use e-cigarettes (odds ratio [OR] 0·72, 95% CI 0·57–0·91). Association of e-cigarette use with quitting did not significantly differ among studies of all smokers using e-cigarettes (irrespective of interest in quitting cigarettes) compared with studies of only smokers interested in cigarette cessation (OR 0·63, 95% CI 0·45–0·86 vs 0·86, 0·60–1·23; p=0·94). Other study characteristics (design, population, comparison group, control variables, time of exposure assessment, biochemical verification of abstinence, and definition of e-cigarette use) were also not associated with the overall effect size (p≥0·77 in all cases). Interpretation As currently being used, e-cigarettes are associated with significantly less quitting among smokers. PMID:26776875

  5. Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial.

    PubMed

    Acri, Mary; Hamovitch, Emily; Mini, Maria; Garay, Elene; Connolly, Claire; McKay, Mary

    2017-12-04

    Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting. This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses. The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems. ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

  6. Crime, perceived safety, and physical activity: A meta-analysis.

    PubMed

    Rees-Punia, Erika; Hathaway, Elizabeth D; Gay, Jennifer L

    2018-06-01

    Perceived safety from crime and objectively-measured crime rates may be associated with physical inactivity. The purpose of this meta-analysis is to estimate the odds of accumulating high levels of physical activity (PA) when the perception of safety from crime is high and when objectively-measured crime is high. Peer-reviewed studies were identified through PubMed, Web of Science, ProQuest Criminal Justice, and ScienceDirect from earliest record through 2016. Included studies measured total PA, leisure-time PA, or walking in addition to perceived safety from crime or objective measures of crime. Mean odds ratios were aggregated with random effects models, and meta-regression was used to examine effects of potential moderators: country, age, and crime/PA measure. Sixteen cross-sectional studies yielded sixteen effects for perceived safety from crime and four effects for objective crime. Those reporting feeling safe from crime had a 27% greater odds of achieving higher levels of physical activity (OR=1.27 [1.08, 1.49]), and those living in areas with higher objectively-measured crime had a 28% reduced odds of achieving higher levels of physical activity (OR=0.72 [0.61, 0.83]). Effects of perceived safety were highly heterogeneous (I 2 =94.09%), but explored moderators were not statistically significant, likely because of the small sample size. Despite the limited number of effects suitable for aggregation, the mean association between perceived safety and PA was significant. As it seems likely that perceived lack of safety from crime constrains PA behaviors, future research exploring moderators of this association may help guide public health recommendations and interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Differential prevalence and associations of overweight and obesity by gender and population group among school learners in South Africa: a cross-sectional study.

    PubMed

    Negash, Sarah; Agyemang, Charles; Matsha, Tandi E; Peer, Nasheeta; Erasmus, Rajiv T; Kengne, Andre P

    2017-01-01

    Factors influencing the increasing prevalence of overweight/obesity among children and adolescents in sub-Saharan Africa remain unclear. We assessed the prevalence and determinants of overweight and obesity and effects on cardio-metabolic profile in school learners in the Western Cape, South Africa. Cross-sectional data were collected from 7 to 18-year-old South African school learners attending 14 schools, randomly selected from 107 government schools in the areas. The learners were selected through stratified random sampling techniques. Logistic regressions were used to assess the determinants of overweight/obesity and its association with cardio-metabolic profile. Among the 1559 participants, the overall prevalence of overweight/obesity was 22.9%. Being a girl (Odds ratio 2.51, 95% CI: 1.92-3.29), or Black African (1.35, 1.04-.75) was associated with increased odds of being overweight/obese. The identified health consequences among the overweight/obese learners differed between the ethnic groups. Overweight/obese coloured (mixed ancestry) learners were more likely to have hypertension (3.27, 1.18-9.08), hypertriglyceridemia (1.94, 0.99-3.78) and low high-density lipoprotein cholesterol (HDL-C) (3.65, 2.33-5.72), overweight/obese Black African learners had higher odds for hypertension (3.62, 1.31-10.04) and low HDL-C (1.56, 1.01-2.40) and overweight/obese White learners were prone to low HDL-C (5.04, 1.35-18.80). Overweight/obesity is highly prevalent among school learners in Western Cape (South Africa), with being female or Black African increasing the odds. That overweight/obesity is also associated with adverse cardio-metabolic risk profile aggravates the problem and suggests worse cardiovascular outcomes in South African young adults in the future.

  8. Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT).

    PubMed

    Haloua, Max H; Volders, José H; Krekel, Nicole M A; Lopes Cardozo, Alexander M F; de Roos, Wifred K; de Widt-Levert, Louise M; van der Veen, Henk; Rijna, Herman; Bergers, Elisabeth; Jóźwiak, Katarzyna; Meijer, Sybren; van den Tol, Petrousjka

    2016-01-01

    Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective. The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). A total of 134 patients with T1–T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either USS (65 patients) or PGS (69 patients). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.- core) and by patient self-evaluation, including patient satisfaction. Time points for follow-up were 3, 6, and 12 months after surgery. Overall cosmetic outcome and patient satisfaction were scored on a 4-point Likert scale (excellent, good, fair, or poor), and outcomes were analyzed using a multilevel, mixed effect, proportional odds model for ordinal responses. Ultrasound-guided breast-conserving surgery achieved better cosmetic outcomes, with 20 % excellence overall and only 6 % rated as poor, whereas 14 % of PGS outcomes were rated excellent and 13 % as poor. USS also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p = 0.067) than PGS. The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (ptrend = 0.002); a volume [40 cc showed odds 2.78-fold higher for a worse outcome than a volume B40 cc. USS resulted in higher patient satisfaction compared with PGS. Ultrasound-guided breast-conserving surgery achieved better overall cosmetic outcomes and patient satisfaction than PGS. Lumpectomy volumes[40 cc resulted in significantly worse cosmetic outcomes.

  9. Association of an adult obesity, blood pressure adulthood socio-economic position.

    PubMed

    Siadat, Zahra Dana; Abdoli, Aminreza; Shahsanaee, Armindokht

    2012-03-01

    The purpose of this study is to investigate an effect of childhood and adulthood socio-economic position on selected cardiovascular risk factors including obesity, blood pressure level and smoking behavior. This is a cross-sectional study performed on 479 individuals, randomly selected by random clustered sampling from men and women aged 30-50 years, living in Esfahan. Their demographic characteristics, education, occupation and smoking behavior were questioned. Their weight, height and blood pressure were also measured, and their BMI (Body Mass Index) was calculated. The data were analyzed by SPSS 19 software. In men, the odds ratio for ever smoking to never smoking at higher levels of education in comparison with the lower levels was 6.08 (2.65-14.11). For manual occupation to non-manual occupation, it was 3.55 (1.88-6.68). The odds ratio for obesity and overweight vs no overweight, for manual occupation to non-manual occupation was 3.12 (1.81-5.40) in men and for father's occupation it was 2.03 (1.10-3.74). In women, their education with the odds ratio of 2.11 (1.17-3.82) and father's occupation with the odds ratio of 6.63 (3.50-12.58) altered their chance of being obese or overweight. Also, in women, the mean systolic blood pressure was significantly lower at higher educational levels and in those whose fathers' occupation were manual but lower in manual workers. The current socio-economic position in individuals is associated with an obesity and smoking behavior, particularly in men. Childhood socio-economic position increases the chance of an obesity and higher blood pressure, particularly in women.

  10. Aspirin and Risk of Subarachnoid Hemorrhage: Systematic Review and Meta-Analysis.

    PubMed

    Phan, Kevin; Moore, Justin M; Griessenauer, Christoph J; Ogilvy, Christopher S; Thomas, Ajith J

    2017-05-01

    Recent studies have suggested that the use of low-dose aspirin may reduce the risk of aneurysmal subarachnoid hemorrhage (aSAH). We aimed to evaluate any association between aspirin use and risk of aSAH based on the literature, and whether this is influenced by duration or frequency of aspirin use. A search of electronic databases was done from inception to September 2016. For each study, data on risk of aSAH in aspirin versus nonaspirin users were used to generate odds ratios and 95% confidence intervals, and combined using inverse variance-weighted averages of logarithmic odds ratios in a random-effects models. From 7 included studies, no significant difference was noted between aspirin use of any duration or frequency and nonaspirin users (odds ratio, 1.00; 95% confidence interval, 0.81-1.24; P =0.99). We found a significant association between short-term use of aspirin (<3 months) and the risk of aSAH (odds ratio, 1.61; 95% confidence interval, 1.20-2.18; P =0.002). No significant difference was found in terms of risk of aSAH for 3 to 12 months, 1 to 3 years, and >3 years of durations of use. No significant association was found between infrequent aspirin use (≤2× per week) or frequent use (≥3× per week) with risk of aSAH. Current evidence suggests that short-term (<3 months) use of aspirin is associated with increased risk of aSAH. Limitations include substantial heterogenity of the included studies. The role of long-term aspirin in reducing risk of aSAH remains unclear and ideally should be addressed by an appropriately designed randomized controlled trial. © 2017 American Heart Association, Inc.

  11. Effect of the planet health intervention on eating disorder symptoms in Massachusetts middle schools, 2005-2008.

    PubMed

    Austin, S Bryn; Spadano-Gasbarro, Jennifer L; Greaney, Mary L; Blood, Emily A; Hunt, Anne T; Richmond, Tracy K; Wang, Monica L; Mezgebu, Solomon; Osganian, Stavroula K; Peterson, Karen E

    2012-01-01

    The Planet Health obesity prevention curriculum has prevented purging and abuse of diet pills (disordered weight control behavior [DWCB]) in middle-school girls in randomized trials, but the effects of Planet Health on DWCB when implemented by schools under dissemination conditions are not known. Massachusetts Department of Public Health and Blue Cross Blue Shield of Massachusetts disseminated Planet Health as part of the 3-year, Healthy Choices obesity prevention program in middle schools. We conducted an evaluation in 45 schools from fall 2005 to spring 2008. We gathered data from school staff to quantify intervention activities, and we gathered anonymous cross-sectional survey data from students on DWCB at baseline and Year 3 follow-up (n = 16,369). Multivariate logistic analyses with generalized estimating equations examined the effect of intervention activities on odds of students reporting DWCB at follow-up. Students in schools reaching a high number of youth with Planet Health lessons on reducing television viewing had lower odds of DWCB at follow-up (odds ratio [OR], 0.80 per 100 lesson-exposures; 95% confidence interval [CI], 0.74-0.85). In addition, reduced odds of DWCB at follow-up were found in schools with active staff teamwork (OR, 0.76; 95% CI, 0.66-0.86) and the presence of programs addressing television viewing goals with staff (OR, 0.38; 95% CI, 0.28-0.53). Combined evidence from efficacy and effectiveness trials and now from dissemination research indicates that appropriately designed obesity prevention programs can achieve DWCB prevention on a large scale.

  12. Acute health effects of the Sea Empress oil spill.

    PubMed

    Lyons, R A; Temple, J M; Evans, D; Fone, D L; Palmer, S R

    1999-05-01

    To investigate whether residents in the vicinity of the Sea Empress tanker spill suffered an increase in self reported physical and psychological symptoms, which might be attributable to exposure to crude oil. Retrospective cohort study; postal questionnaire including demographic details, a symptom checklist, beliefs about health effects of oil and the Hospital Anxiety and Depression and SF-36 mental health scales. Populations living in four coastal towns on the exposed south Pembrokeshire coast and two control towns on the unexposed north coast. 539 exposed and 550 unexposed people sampled at random from the family health services authority age-sex register who completed questionnaires. Adjusted odds ratios for self reported physical symptoms; scores on the Hospital Anxiety and Depression and SF-36 mental health scales, in 1089 people who responded out of a possible 1585 (69%). Living in areas exposed to the crude oil spillage was significantly associated with higher anxiety and depression scores, worse mental health; and self reported headache (odds ratio = 2.35, 95% CI 1.56, 3.55), sore eyes (odds ratio = 1.96, 95% CI 1.06, 3.62), and sore throat (odds ratio = 1.70, 95% CI 1.12, 2.60) after adjusting for age, sex, smoking status, anxiety, and the belief that oil had affected health. People living in exposed areas reported higher rates of physical and psychological symptoms than control areas. Symptoms significantly associated with exposure after adjustment for anxiety and health beliefs were those expected from the known toxicological effect of oil, suggesting a direct health effect on the exposed population.

  13. Acute health effects of the Sea Empress oil spill

    PubMed Central

    Lyons, R. A.; Temple, J. M.; Evans, D.; Fone, D. L.; Palmer, S. R.

    1999-01-01

    STUDY OBJECTIVE: To investigate whether residents in the vicinity of the Sea Empress tanker spill suffered an increase in self reported physical and psychological symptoms, which might be attributable to exposure to crude oil. DESIGN: Retrospective cohort study; postal questionnaire including demographic details, a symptom checklist, beliefs about health effects of oil and the Hospital Anxiety and Depression and SF-36 mental health scales. SETTING: Populations living in four coastal towns on the exposed south Pembrokeshire coast and two control towns on the unexposed north coast. PATIENTS: 539 exposed and 550 unexposed people sampled at random from the family health services authority age-sex register who completed questionnaires. MAIN RESULTS: Adjusted odds ratios for self reported physical symptoms; scores on the Hospital Anxiety and Depression and SF-36 mental health scales, in 1089 people who responded out of a possible 1585 (69%). CONCLUSIONS: Living in areas exposed to the crude oil spillage was significantly associated with higher anxiety and depression scores, worse mental health; and self reported headache (odds ratio = 2.35, 95% CI 1.56, 3.55), sore eyes (odds ratio = 1.96, 95% CI 1.06, 3.62), and sore throat (odds ratio = 1.70, 95% CI 1.12, 2.60) after adjusting for age, sex, smoking status, anxiety, and the belief that oil had affected health. People living in exposed areas reported higher rates of physical and psychological symptoms than control areas. Symptoms significantly associated with exposure after adjustment for anxiety and health beliefs were those expected from the known toxicological effect of oil, suggesting a direct health effect on the exposed population.   PMID:10396538

  14. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    PubMed

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1.15-4.53]) and CDS + coaching arm (adjusted odds ratio, 2.60 [95% CI, 1.25-5.41]) and higher use of HEDIS codes for nutrition or physical activity counseling (CDS arm, 45%; CDS + coaching arm, 25%; P < .001 compared with usual care arm). An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families resulted in improved childhood BMI. Both interventions improved the quality of care for childhood obesity. clinicaltrials.gov Identifier: NCT01537510.

  15. Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis.

    PubMed

    Hey, Juliane; Thompson-Leduc, Philippe; Kirson, Noam Y; Zimmer, Louise; Wilkins, Dana; Rice, Bernie; Iankova, Irena; Krause, Alexander; Schonfeld, Sophie A; DeBrase, Christopher R; Bozzette, Samuel; Schuetz, Philipp

    2018-05-01

    Although effective for bacterial lower respiratory tract infections (LRTIs), antibiotic treatment is often incorrectly prescribed for non-bacterial LRTIs. Procalcitonin has emerged as a promising biomarker to diagnose bacterial infections and guide antibiotic treatment decisions. As part of a regulatory submission to the U.S. Food and Drug Administration, this systematic review and meta-analysis summarizes the effects of procalcitonin-guided antibiotic stewardship on antibiotic use and clinical outcomes in adult LRTI patients. PubMed and the Cochrane Database of Systematic Reviews were searched for English-language randomized controlled trials published between January 2004 and May 2016. Random and fixed effects meta-analyses were performed to study efficacy (initiation of antibiotics, antibiotic use) and safety (mortality, length of hospital stay). Eleven trials were retained, comprising 4090 patients. Procalcitonin-guided patients had lower odds of antibiotic initiation (odds ratio: 0.26; 95% confidence interval [CI]: 0.13-0.52) and shorter mean antibiotic use (weighted mean difference: -2.15 days; 95% CI: -3.30 to -0.99) compared to patients treated with standard care. Procalcitonin use had no adverse impact on mortality (relative risk: 0.94; 95% CI: 0.69-1.28) and length of hospital stay (weighted mean difference: -0.15 days; 95% CI: -0.60 to 0.30). Procalcitonin guidance reduces antibiotic initiation and use among adults with LRTIs with no apparent adverse impact on length of hospital stay or mortality.

  16. Obesity and response to anti-tumor necrosis factor-α agents in patients with select immune-mediated inflammatory diseases: A systematic review and meta-analysis.

    PubMed

    Singh, Siddharth; Facciorusso, Antonio; Singh, Abha G; Casteele, Niels Vande; Zarrinpar, Amir; Prokop, Larry J; Grunvald, Eduardo L; Curtis, Jeffrey R; Sandborn, William J

    2018-01-01

    We sought to evaluate the association between obesity and response to anti-tumor necrosis factor-α (TNF) agents, through a systematic review and meta-analysis. Through a systematic search through January 24, 2017, we identified randomized controlled trials (RCTs) or observational studies in adults with select immune-mediated inflammatory diseases-inflammatory bowel diseases (IBD), rheumatoid arthritis (RA), spondyloarthropathies (SpA), psoriasis and psoriatic arthritis (PsA)-treated with anti-TNF agents, and reporting outcomes, stratified by body mass index (BMI) categories or weight. Primary outcome was failure to achieve clinical remission or response or treatment modification. We performed random effects meta-analysis and estimated odds ratios (OR) and 95% confidence interval (CI). Based on 54 cohorts including 19,372 patients (23% obese), patients with obesity had 60% higher odds of failing therapy (OR,1.60; 95% CI,1.39-1.83;I2 = 71%). Dose-response relationship was observed (obese vs. normal BMI: OR,1.87 [1.39-2.52]; overweight vs. normal BMI: OR,1.38 [1.11-1.74],p = 0.11); a 1kg/m2 increase in BMI was associated with 6.5% higher odds of failure (OR,1.065 [1.043-1.087]). These effects were observed across patients with rheumatic diseases, but not observed in patients with IBD. Effect was consistent based on dosing regimen/route, study design, exposure definition, and outcome measures. Less than 10% eligible RCTs reported outcomes stratified by BMI. Obesity is an under-reported predictor of inferior response to anti-TNF agents in patients with select immune-mediated inflammatory diseases. A thorough evaluation of obesity as an effect modifier in clinical trials is warranted, and intentional weight loss may serve as adjunctive treatment in patients with obesity failing anti-TNF therapy.

  17. Risperidone added to parent training and stimulant medication: effects on attention-deficit/hyperactivity disorder, oppositional defiant disorder, conduct disorder, and peer aggression.

    PubMed

    Gadow, Kenneth D; Arnold, L Eugene; Molina, Brooke S G; Findling, Robert L; Bukstein, Oscar G; Brown, Nicole V; McNamara, Nora K; Rundberg-Rivera, E Victoria; Li, Xiaobai; Kipp, Heidi L; Schneider, Jayne; Farmer, Cristan A; Baker, Jennifer L; Sprafkin, Joyce; Rice, Robert R; Bangalore, Srihari S; Butter, Eric M; Buchan-Page, Kristin A; Hurt, Elizabeth A; Austin, Adrienne B; Grondhuis, Sabrina N; Aman, Michael G

    2014-09-01

    In this study, we aimed to expand on our prior research into the relative efficacy of combining parent training, stimulant medication, and placebo (Basic therapy) versus parent training, stimulant, and risperidone (Augmented therapy) by examining treatment effects for attention-deficit/hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD) symptoms and peer aggression, symptom-induced impairment, and informant discrepancy. Children (6-12 years of age; N = 168) with severe physical aggression, ADHD, and co-occurring ODD/CD received an open trial of parent training and stimulant medication for 3 weeks. Participants failing to show optimal clinical response were randomly assigned to Basic or Augmented therapy for an additional 6 weeks. Compared with Basic therapy, children receiving Augmented therapy experienced greater reduction in parent-rated ODD severity (p = .002, Cohen's d = 0.27) and peer aggression (p = .02, Cohen's d = 0.32) but not ADHD or CD symptoms. Fewer children receiving Augmented (16%) than Basic (40%) therapy were rated by their parents as impaired by ODD symptoms at week 9/endpoint (p = .008). Teacher ratings indicated greater reduction in ADHD severity (p = .02, Cohen's d = 0.61) with Augmented therapy, but not for ODD or CD symptoms or peer aggression. Although both interventions were associated with marked symptom reduction, a relatively large percentage of children were rated as impaired for at least 1 targeted disorder at week 9/endpoint by parents (Basic 47%; Augmented 27%) and teachers (Basic 48%; Augmented 38%). Augmented therapy was superior to Basic therapy in reducing severity of ADHD and ODD symptoms, peer aggression, and symptom-induced impairment, but clinical improvement was generally context specific, and effect sizes ranged from small to moderate. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study); http://clinicaltrials.gov/; NCT00796302. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  18. Adverse Childhood Experiences Predict Alcohol Consumption Patterns Among Kenyan Mothers.

    PubMed

    Goodman, Michael L; Grouls, Astrid; Chen, Catherine X; Keiser, Philip H; Gitari, Stanley

    2017-04-16

    We analyze whether adverse childhood experiences predict weekly alcohol consumption patterns of Kenyan mothers and their partners. Randomly selected respondents (n = 1,976) were asked about adverse childhood experiences and alcohol consumption patterns for themselves and their partners. Fixed effect models were used to determine odds of reporting weekly alcohol consumption and the number of beverages typically consumed, controlling for wealth, age, education, and partner alcohol consumption. Cumulative adverse childhood experiences predicted higher odds of weekly alcohol consumption of the respondent and her partner. Childhood exposure to physical abuse, emotional neglect, and mental illness in the household significantly increased odds of weekly alcohol consumption by the respondent. More drinks consumed per typical session were higher among respondents with more cumulative adversities. Physical and emotional abuse significantly predicted number of drinks typically consumed by the respondent. To our knowledge, this is the first study to explore and find associations between adverse childhood experiences and alcohol consumption in Kenya. Consistent with high-income settings, exposure to childhood adversities predicted greater alcohol consumption among Kenyan women.

  19. Meta-analysis on shift work and risks of specific obesity types.

    PubMed

    Sun, M; Feng, W; Wang, F; Li, P; Li, Z; Li, M; Tse, G; Vlaanderen, J; Vermeulen, R; Tse, L A

    2018-01-01

    This systematic review and meta-analysis evaluated the associations between shift work patterns and risks of specific types of obesity. PubMed was searched until March 2017 for observational studies that examined the relationships between shift work patterns and obesity. Odds ratio for obesity was extracted using a fixed-effects or random-effects model. Subgroup meta-analyses were carried out for study design, specific obesity types and characteristics of shift work pattern. A total of 28 studies were included in this meta-analysis. The overall odds ratio of night shift work was 1.23 (95% confidence interval = 1.17-1.29) for risk of obesity/overweight. Cross-sectional studies showed a higher risk of 1.26 than those with the cohort design (risk ratio = 1.10). Shift workers had a higher frequency of developing abdominal obesity (odds ratio = 1.35) than other obesity types. Permanent night workers demonstrated a 29% higher risk than rotating shift workers (odds ratio 1.43 vs. 1.14). This meta-analysis confirmed the risks of night shift work for the development of overweight and obesity with a potential gradient association suggested, especially for abdominal obesity. Modification of working schedules is recommended, particularly for prolonged permanent night work. More accurate and detailed measurements on shift work patterns should be conducted in future research. © 2017 World Obesity Federation.

  20. Heterogeneity in Early Responses in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).

    PubMed

    Dhruva, Sanket S; Huang, Chenxi; Spatz, Erica S; Coppi, Andreas C; Warner, Frederick; Li, Shu-Xia; Lin, Haiqun; Xu, Xiao; Furberg, Curt D; Davis, Barry R; Pressel, Sara L; Coifman, Ronald R; Krumholz, Harlan M

    2017-07-01

    Randomized trials of hypertension have seldom examined heterogeneity in response to treatments over time and the implications for cardiovascular outcomes. Understanding this heterogeneity, however, is a necessary step toward personalizing antihypertensive therapy. We applied trajectory-based modeling to data on 39 763 study participants of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to identify distinct patterns of systolic blood pressure (SBP) response to randomized medications during the first 6 months of the trial. Two trajectory patterns were identified: immediate responders (85.5%), on average, had a decreasing SBP, whereas nonimmediate responders (14.5%), on average, had an initially increasing SBP followed by a decrease. Compared with those randomized to chlorthalidone, participants randomized to amlodipine (odds ratio, 1.20; 95% confidence interval [CI], 1.10-1.31), lisinopril (odds ratio, 1.88; 95% CI, 1.73-2.03), and doxazosin (odds ratio, 1.65; 95% CI, 1.52-1.78) had higher adjusted odds ratios associated with being a nonimmediate responder (versus immediate responder). After multivariable adjustment, nonimmediate responders had a higher hazard ratio of stroke (hazard ratio, 1.49; 95% CI, 1.21-1.84), combined cardiovascular disease (hazard ratio, 1.21; 95% CI, 1.11-1.31), and heart failure (hazard ratio, 1.48; 95% CI, 1.24-1.78) during follow-up between 6 months and 2 years. The SBP response trajectories provided superior discrimination for predicting downstream adverse cardiovascular events than classification based on difference in SBP between the first 2 measurements, SBP at 6 months, and average SBP during the first 6 months. Our findings demonstrate heterogeneity in response to antihypertensive therapies and show that chlorthalidone is associated with more favorable initial response than the other medications. © 2017 American Heart Association, Inc.

  1. Does hearing the patient perspective improve consultation skills in examinations? An exploratory randomized controlled trial in medical undergraduate education.

    PubMed

    Snow, Rosamund; Crocker, Joanna; Talbot, Katherine; Moore, Jane; Salisbury, Helen

    2016-12-01

    Medical education increasingly includes patient perspectives, but few studies look at the impact on students' proficiency in standard examinations. We explored students' exam performance after viewing video of patients' experiences. Eighty-eight medical students were randomized to one of two e-learning modules. The experimental group saw video clips of patients describing their colposcopy, while the control group viewed a clinician describing the procedure. Students then completed a Multiple Choice Questionnaire (MCQ) and were assessed by a blinded clinical examiner in an Objective Structured Clinical Examination (OSCE) with a blinded simulated patient (SP). The SP scored students using the Doctors' Interpersonal Skills Questionnaire (DISQ). Students rated the module's effect on their skills and confidence. Regression analyses were used to compare the effect of the two modules on these outcomes, adjusting for gender and graduate entry. The experimental group performed better in the OSCE than the control group (odds ratio 2.7 [95%CI 1.2-6.1]; p = 0.016). They also reported significantly more confidence in key areas, including comfort with patients' emotions (odds ratio 6.4 [95%CI 2.7-14.9]; p < 0.0005). There were no other significant differences. Teaching that included recorded elements of real patient experience significantly improved students' examination performance and confidence.

  2. Toxoplasmosis and epilepsy--systematic review and meta analysis.

    PubMed

    Ngoungou, Edgard B; Bhalla, Devender; Nzoghe, Amandine; Dardé, Marie-Laure; Preux, Pierre-Marie

    2015-02-01

    Toxoplasmosis is an important, widespread, parasitic infection caused by Toxoplasma gondii. The chronic infection in immunocompetent patients, usually considered as asymptomatic, is now suspected to be a risk factor for various neurological disorders, including epilepsy. We aimed to conduct a systematic review and meta-analysis of the available literature to estimate the risk of epilepsy due to toxoplasmosis. A systematic literature search was conducted of several databases and journals to identify studies published in English or French, without date restriction, which looked at toxoplasmosis (as exposure) and epilepsy (as disease) and met certain other inclusion criteria. The search was based on keywords and suitable combinations in English and French. Fixed and random effects models were used to determine odds ratios, and statistical significance was set at 5.0%. Six studies were identified, with an estimated total of 2888 subjects, of whom 1280 had epilepsy (477 positive for toxoplasmosis) and 1608 did not (503 positive for toxoplasmosis). The common odds ratio (calculated) by random effects model was 2.25 (95% CI 1.27-3.9), p = 0.005. Despite the limited number of studies, and a lack of high-quality data, toxoplasmosis should continue to be regarded as an epilepsy risk factor. More and better studies are needed to determine the real impact of this parasite on the occurrence of epilepsy.

  3. Home visits during pregnancy: consequences on pregnancy outcome, use of health services, and women's situations.

    PubMed

    Blondel, B; Bréart, G

    1995-08-01

    This review of eight randomized controlled trials assessed two different types of home visits during pregnancy: (1) those offering social support to high-risk women; and (2) those providing medical care to women with complications. In both categories, pregnancy outcome was not improved when women received home visits. The summary odds ratio for preterm delivery (< 37 weeks) was 1.0 (95% CI: 0.8 to 1.1). Nor did the home visits decrease the rate of hospital admission for women with complications (mainly threatened preterm labor or toxemia); the corresponding summary odds ratio was 0.9 (95% CI: 0.7 to 1.2). Nevertheless in some trials home visits had positive effects on women (medical knowledge, support levels, health habits, and satisfaction). The randomized controlled trials provide little evidence that programs offering home visits are effective in improving either pregnancy outcome or the use of health services. A better integration of hospital and home services might allow a more rational use of health services for women with complications. In addition, we need to define more precisely the content of home visits providing social support. For this, further research is required on how emotional support, health education, and advice influence the health of women and infants and mother-child interactions.

  4. Effects of Exercise on Mild-to-Moderate Depressive Symptoms in the Postpartum Period: A Meta-analysis.

    PubMed

    McCurdy, Ashley P; Boulé, Normand G; Sivak, Allison; Davenport, Margie H

    2017-06-01

    To examine the influence of exercise on depressive symptoms and the prevalence of depression in the postpartum period. A structured search of MEDLINE, EMBASE, CINAHL, Sport Discus, Ovid's All EBM Reviews, and ClinicalTrials.gov databases was performed with dates from the beginning of the databases until June 16, 2016. The search combined keywords and MeSH-like terms including, but not limited to, "exercise," "postpartum," "depression," and "randomized controlled trial." Randomized controlled trials comparing postpartum exercise (structured, planned, repetitive physical activity) with the standard care for which outcomes assessing depressive symptoms or depressive episodes (as defined by trial authors) were assessed. Trials were identified as prevention trials (women from the general postpartum population) or treatment trials (women were classified as having depression by the trial authors). Effect sizes with 95% confidence intervals (CIs) were calculated using Hedges' g method and standardized mean differences in postintervention depression outcomes were pooled using a random-effects model. Across all 16 trials (1,327 women), the pooled standardized mean difference was -0.34 (95% CI -0.50 to -0.19, I=37%), suggesting a small effect of exercise among all postpartum women on depressive symptoms. Among the 10 treatment trials, a moderate effect size of exercise on depressive symptoms was found (standardized mean difference-0.48, 95% CI -0.73 to -0.22, I=42%). In six prevention trials, a small effect (standardized mean difference-0.22, 95% CI -0.36 to -0.08, I=2%) was found. In women with depression preintervention, exercise increased the odds of resolving depression postintervention by 54% (odds ratio 0.46, Mantel-Haenszel method, 95% CI 0.25-0.84, I=0%). The trials included in this meta-analysis were small and some had methodologic limitations. Light-to-moderate intensity aerobic exercise improves mild-to-moderate depressive symptoms and increases the likelihood that mild-to-moderate depression will resolve.

  5. Water, Sanitation, Hygiene, and Soil-Transmitted Helminth Infection: A Systematic Review and Meta-Analysis

    PubMed Central

    Strunz, Eric C.; Addiss, David G.; Stocks, Meredith E.; Ogden, Stephanie; Utzinger, Jürg; Freeman, Matthew C.

    2014-01-01

    Background Preventive chemotherapy represents a powerful but short-term control strategy for soil-transmitted helminthiasis. Since humans are often re-infected rapidly, long-term solutions require improvements in water, sanitation, and hygiene (WASH). The purpose of this study was to quantitatively summarize the relationship between WASH access or practices and soil-transmitted helminth (STH) infection. Methods and Findings We conducted a systematic review and meta-analysis to examine the associations of improved WASH on infection with STH (Ascaris lumbricoides, Trichuris trichiura, hookworm [Ancylostoma duodenale and Necator americanus], and Strongyloides stercoralis). PubMed, Embase, Web of Science, and LILACS were searched from inception to October 28, 2013 with no language restrictions. Studies were eligible for inclusion if they provided an estimate for the effect of WASH access or practices on STH infection. We assessed the quality of published studies with the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. A total of 94 studies met our eligibility criteria; five were randomized controlled trials, whilst most others were cross-sectional studies. We used random-effects meta-analyses and analyzed only adjusted estimates to help account for heterogeneity and potential confounding respectively. Use of treated water was associated with lower odds of STH infection (odds ratio [OR] 0.46, 95% CI 0.36–0.60). Piped water access was associated with lower odds of A. lumbricoides (OR 0.40, 95% CI 0.39–0.41) and T. trichiura infection (OR 0.57, 95% CI 0.45–0.72), but not any STH infection (OR 0.93, 95% CI 0.28–3.11). Access to sanitation was associated with decreased likelihood of infection with any STH (OR 0.66, 95% CI 0.57–0.76), T. trichiura (OR 0.61, 95% CI 0.50–0.74), and A. lumbricoides (OR 0.62, 95% CI 0.44–0.88), but not with hookworm infection (OR 0.80, 95% CI 0.61–1.06). Wearing shoes was associated with reduced odds of hookworm infection (OR 0.29, 95% CI 0.18–0.47) and infection with any STH (OR 0.30, 95% CI 0.11–0.83). Handwashing, both before eating (OR 0.38, 95% CI 0.26–0.55) and after defecating (OR 0.45, 95% CI 0.35–0.58), was associated with lower odds of A. lumbricoides infection. Soap use or availability was significantly associated with lower infection with any STH (OR 0.53, 95% CI 0.29–0.98), as was handwashing after defecation (OR 0.47, 95% CI 0.24–0.90). Observational evidence constituted the majority of included literature, which limits any attempt to make causal inferences. Due to underlying heterogeneity across observational studies, the meta-analysis results reflect an average of many potentially distinct effects, not an average of one specific exposure-outcome relationship. Conclusions WASH access and practices are generally associated with reduced odds of STH infection. Pooled estimates from all meta-analyses, except for two, indicated at least a 33% reduction in odds of infection associated with individual WASH practices or access. Although most WASH interventions for STH have focused on sanitation, access to water and hygiene also appear to significantly reduce odds of infection. Overall quality of evidence was low due to the preponderance of observational studies, though recent randomized controlled trials have further underscored the benefit of handwashing interventions. Limited use of the Joint Monitoring Program's standardized water and sanitation definitions in the literature restricted efforts to generalize across studies. While further research is warranted to determine the magnitude of benefit from WASH interventions for STH control, these results call for multi-sectoral, integrated intervention packages that are tailored to social-ecological contexts. Please see later in the article for the Editors' Summary PMID:24667810

  6. Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial.

    PubMed

    Fitzgerald, G K; Fritz, J M; Childs, J D; Brennan, G P; Talisa, V; Gil, A B; Neilson, B D; Abbott, J H

    2016-08-01

    (1) Do treatment effects differ between participants receiving manual therapy (MT) with exercise compared to subjects who don't, (2) are treatment effects sustained better when participants receive booster sessions compared to those who don't over a one year period in subjects with knee osteoarthritis (KOA)? Multi-center, 2 × 2 factorial randomized clinical trial. 300 participants with knee OA were randomized to four groups: exercise-no boosters (Ex), exercise-with boosters (Ex+B), manual therapy+exercise-no boosters (MT+Ex), manual therapy+exercise-with boosters (MT+Ex+B). The primary outcome was the Western Ontario and McMaster osteoarthritis index (WOMAC) at 1 year. Secondary outcomes included knee pain, physical performance tests, and proportions of participants meeting treatment responder criteria. There were no differences between groups on the WOMAC at 1 year or on any performance-based measures. Secondary analyses indicated a) better scores on the WOMAC and greater odds of being a treatment responder at 9 weeks for participants receiving MT, b) greater odds of being a treatment responder at 1 year for participants receiving boosters. Exploratory interaction analysis suggested knee pain decreases for participants receiving boosters and increases for participants not receiving boosters from 9 weeks to 1 year. MT or use of boosters with exercise did not result in additive improvement in the primary outcome at 1 year. Secondary outcomes suggest MT may have some short term benefit, and booster sessions may improve responder status and knee pain at 1 year. However, the role of booster sessions remains unclear in sustaining treatment effects and warrants further study. gov (NCT01314183). Copyright © 2016 Osteoarthritis Research Society International. All rights reserved.

  7. The effect of Rosa (L. Rosa canina) on the incidence of urinary tract infection in the puerperium: A randomized placebo-controlled trial.

    PubMed

    Seifi, Mahdieh; Abbasalizadeh, Shamsi; Mohammad-Alizadeh-Charandabi, Sakineh; Khodaie, Laleh; Mirghafourvand, Mojgan

    2018-01-01

    Urinary tract infection (UTI) is an infection that can occur in any area of the urinary tract which is characterized by a positive urine culture (U/C). The risk of UTI following cesarean section (CS) increases due to procedures such as catheterization. In vitro studies have demonstrated the effect of Rosa canina fruit in preventing Escherichia coli growth. This study was conducted to determine the effect of R. canina fruit in preventing the incidence of UTI in women following CS. This triple-blind randomized clinical trial was conducted in 2016 on 400 women following CS with negative U/C in Alzahra and Taleghani educational hospitals in the city of Tabriz-Iran. Participants were assigned into two groups of 200 women using block randomization. Each group received a twice daily dose of 500 mg capsules containing R. canina or placebo from the second day after CS for 20 days. Women were assessed by U/C on the 7th-10th and 20th days following CS. UTI was significantly lower in the intervention group compared with the control in the follow-ups conducted on the 7th-10th days (odds ratio = 0.22; confidence interval 95% [0.07, 0.67]; p = .006) and 20th day (odds ratio = 0.32; confidence interval 95% [0.14, 0.75]; p = .008). But the incidence of cystitis in the two groups was not statistically significant (p > .05). R. canina fruit capsules were able to reduce the incidence of UTI after CS. Thus, it is likely that administration of this medication can promote maternal health following CS. Copyright © 2017 John Wiley & Sons, Ltd.

  8. Using daily text messages to improve adherence to infant micronutrient powder (MNP) packets in rural western China: A cluster-randomized controlled trial

    PubMed Central

    Wang, Xu; Liu, Chengfang; Zhang, Linxiu; Yue, Ai; Medina, Alexis; Rozelle, Scott

    2018-01-01

    Objective To evaluate the effectiveness of daily text messages as a means to improve caregivers’ adherence to infant micronutrient powder (MNP) in rural Shaanxi Province of China. Methodology 638 infants aged 6–11 months in 234 villages were involved in a cluster-randomized controlled trial (RCT). All caregivers were given free infant MNP packets at baseline in April 2013 and the follow-up survey was in July 2013. We randomly assigned 318 infants in 117 villages to treatment group (receiving daily text message) and 320 infants in the other 117 villages as control group. Results On average, daily text messages increased the number of MNP packets fed (marginal effect = 4.63; 95% confidence interval (CI) = 0.16, 9.10). The text message is more likely to increase the consumption of MNP packets if the primary caregiver was the mother (marginal effect = 12.19; 95% CI = 0.69, 23.68). Receiving the text message appears to significantly increase the likelihood of full adherence when the primary caregiver can either check (odds ratio = 2.93; 95% CI = 1.34, 6.40) or knows how to send (odds ratio = 3.26; 95% CI = 1.53, 6.97) text messages. Conclusion Daily text messages improved the consumption of infant MNP packets. However, the impact was not large enough to increase the probability of caregivers being fully adherent to the feeding instruction, which is to feed 5–7 packets per week as recommended. In addition, when the mother is the caregiver and when the caregiver can check or knows how to send text messages there is greater adherence by the primary caregivers. Trial registration http://www.isrctn.com/ISRCTN44149146 PMID:29352304

  9. Impact of patient position on the incidence of ventilator-associated pneumonia: a meta-analysis of randomized controlled trials.

    PubMed

    Alexiou, Vangelis G; Ierodiakonou, Vrettos; Dimopoulos, George; Falagas, Matthew E

    2009-12-01

    The aim of this study is to summarize the effect of position (prone and semirecumbent 45 degrees ) of mechanically ventilated patients on the incidence of ventilator-associated pneumonia (VAP) and other outcomes. A systematic search for randomized control trials (RCTs) was done. We estimated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using fixed effects model or random effects model, where appropriate. For continuous variables, we calculated the estimation of weighted mean differences. We analyzed data extracted from 3 RCTs studying the semirecumbent 45 degrees and 4 RCTs studying the prone position with a total of 337 and 1018 patients, respectively. The odds of developing clinically diagnosed VAP were significantly lower among patients in the semirecumbent 45 degrees position compared to patients in the supine position (OR = 0.47; 95% CI, 0.27-0.82; 337 patients). The comparison of prone vs supine position group showed a moderate trend toward better outcomes regarding the incidence of clinically diagnosed VAP among patients in the prone position (OR = 0.80; 95% CI, 0.60-1.08; 1018 patients). The subanalysis regarding the incidence of microbiologically documented VAP, the length of intensive care unit stay, and the duration of mechanical ventilation showed that patients in the semirecumbent 45 degrees position have a moderate trend toward better clinical outcomes. This meta-analysis provides additional evidence that the usual practice of back-rest elevation of 15 degrees to 30 degrees is not sufficient to prevent VAP in mechanically ventilated patients. Patients positioned semirecumbently 45 degrees have significantly lower incidence of clinically diagnosed VAP compared to patients positioned supinely. On the other hand, the incidence of clinically diagnosed VAP among patients positioned pronely does not differ significantly from the incidence of clinically diagnosed VAP among patients positioned supinely.

  10. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus.

    PubMed

    Sami, S S; Subramanian, V; Butt, W M; Bejkar, G; Coleman, J; Mannath, J; Ragunath, K

    2015-01-01

    High-definition endoscopy systems provide superior image resolution. The aim of this study was to assess the utility of high definition compared with standard definition endoscopy system for detecting dysplastic lesions in patients with Barrett's esophagus. A retrospective cohort study of patients with non-dysplastic Barrett's esophagus undergoing routine surveillance was performed. Data were retrieved from the central hospital electronic database. Procedures performed for non-surveillance indications, Barrett's esophagus Prague C0M1 classification with no specialized intestinal metaplasia on histology, patients diagnosed with any dysplasia or cancer on index endoscopy, and procedures using advanced imaging techniques were excluded. Logistic regression models were constructed to estimate adjusted odds ratios and 95% confidence intervals comparing outcomes with standard definition and high-definition systems. The high definition was superior to standard definition system in targeted detection of all dysplastic lesions (odds ratio 3.27, 95% confidence interval 1.27-8.40) as well as overall dysplasia detected on both random and target biopsies (odds ratio 2.36, 95% confidence interval 1.50-3.72). More non-dysplastic lesions were detected with the high-definition system (odds ratio 1.16, 95% confidence interval 1.01-1.33). There was no difference between high definition and standard definition endoscopy in the overall (random and target) high-grade dysplasia or cancers detected (odds ratio 0.93, 95% confidence interval 0.83-1.04). Trainee endoscopists, number of biopsies taken, and male sex were all significantly associated with a higher yield for dysplastic lesions. The use of the high-definition endoscopy system is associated with better targeted detection of any dysplasia during routine Barrett's esophagus surveillance. However, high-definition endoscopy cannot replace random biopsies at present time. © 2014 International Society for Diseases of the Esophagus.

  11. Paracetamol (Acetaminophen) in stroke 2 (PAIS 2): protocol for a randomized, placebo-controlled, double-blind clinical trial to assess the effect of high-dose paracetamol on functional outcome in patients with acute stroke and a body temperature of 36.5 °C or above.

    PubMed

    de Ridder, Inger R; de Jong, Frank Jan; den Hertog, Heleen M; Lingsma, Hester F; van Gemert, H Maarten A; Schreuder, A H C M L Tobien; Ruitenberg, Annemieke; Maasland, E Lisette; Saxena, Ritu; Oomes, Peter; van Tuijl, Jordie; Koudstaal, Peter J; Kappelle, L Jaap; Algra, Ale; van der Worp, H Bart; Dippel, Diederik W J

    2015-04-01

    In the first hours after stroke onset, subfebrile temperatures and fever have been associated with poor functional outcome. In the first Paracetamol (Acetaminophen) in Stroke trial, a randomized clinical trial of 1400 patients with acute stroke, patients who were treated with high-dose paracetamol showed more improvement on the modified Rankin Scale at three-months than patients treated with placebo, but this difference was not statistically significant. In the 661 patients with a baseline body temperature of 37.0 °C or above, treatment with paracetamol increased the odds of functional improvement (odds ratio 1.43; 95% confidence interval: 1.02-1.97). This relation was also found in the patients with a body temperature of 36.5 °C or higher (odds ratio 1.31; 95% confidence interval 1.01-1.68). These findings need confirmation. The study aims to assess the effect of high-dose paracetamol in patients with acute stroke and a body temperature of 36.5 °C or above on functional outcome. The Paracetamol (Acetaminophen) In Stroke 2 trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial. We use a power of 85% to detect a significant difference in the scores on the modified Rankin Scale of the paracetamol group compared with the placebo group at a level of significance of 0.05 and assume a treatment effect of 7%. Fifteen-hundred patients with acute ischemic stroke or intracerebral hemorrhage and a body temperature of 36.5 °C or above will be included within 12 h of symptom onset. Patients will be treated with paracetamol in a daily dose of six-grams or matching placebo for three consecutive days. The Paracetamol (Acetaminophen) In Stroke 2 trial has been registered as NTR2365 in The Netherlands Trial Register. The primary outcome will be improvement on the modified Rankin Scale at three-months as analyzed by ordinal logistic regression. If high-dose paracetamol will be proven effective, a simple, safe, and extremely cheap therapy will be available for many patients with acute stroke worldwide. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  12. A mixed-effects regression model for longitudinal multivariate ordinal data.

    PubMed

    Liu, Li C; Hedeker, Donald

    2006-03-01

    A mixed-effects item response theory model that allows for three-level multivariate ordinal outcomes and accommodates multiple random subject effects is proposed for analysis of multivariate ordinal outcomes in longitudinal studies. This model allows for the estimation of different item factor loadings (item discrimination parameters) for the multiple outcomes. The covariates in the model do not have to follow the proportional odds assumption and can be at any level. Assuming either a probit or logistic response function, maximum marginal likelihood estimation is proposed utilizing multidimensional Gauss-Hermite quadrature for integration of the random effects. An iterative Fisher scoring solution, which provides standard errors for all model parameters, is used. An analysis of a longitudinal substance use data set, where four items of substance use behavior (cigarette use, alcohol use, marijuana use, and getting drunk or high) are repeatedly measured over time, is used to illustrate application of the proposed model.

  13. Meta-analysis: the association of oesophageal adenocarcinoma with symptoms of gastro-oesophageal reflux

    PubMed Central

    Rubenstein, J. H.; Taylor, J. B.

    2012-01-01

    Background Endoscopic screening has been proposed for patients with symptoms of gastro-oesophageal reflux disease (GERD) in the hope of reducing mortality from oesophageal adenocarcinoma. Assessing the net benefits of such a strategy requires a precise understanding of the cancer risk in the screened population. Aim To estimate precisely the association between symptoms of GERD and oesophageal adenocarcinoma. Methods Systematic review and meta-analysis of population-based studies with strict ascertainment of exposure and outcomes. Results Five eligible studies were identified. At least weekly symptoms of GERD increased the odds of oesophageal adenocarcinoma fivefold (odds ratio = 4.92; 95% confidence interval = 3.90, 6.22), and daily symptoms increased the odds sevenfold (random effects summary odds ratio = 7.40, 95% confidence interval = 4.94, 11.1), each compared with individuals without symptoms or less frequent symptoms. Duration of symptoms was also associated with oesophageal adenocarcinoma, but with very heterogeneous results, and unclear thresholds. Conclusions Frequent GERD symptoms are strongly associated with oesophageal adenocarcinoma. These results should be useful in developing epidemiological models of the development of oesophageal adenocarcinoma, and in models of interventions aimed at reducing mortality from this cancer. PMID:20955441

  14. The Association between Near Work Activities and Myopia in Children—A Systematic Review and Meta-Analysis

    PubMed Central

    2015-01-01

    Myopia has a multifactorial etiology, although environmental factors are predominant in determining its current patterns. Currently, associations between near work activities and myopia have not been consistently observed. Therefore, we performed a systematic review to quantify the effect of near work activities on myopia in children. Relevant articles published between 1989 and 2014 were identified in MEDLINE, Embase, and the Cochrane Library, and the citation lists were reviewed. Twelve cohort studies and 15 cross-sectional studies were included (25,025 children aged between 6 and 18 years). The I 2 statistic was used to assess heterogeneity. Study-level data were pooled using a random-effects model or a fixed-effects model (when less than 5 studies were included). We found that more time spent on near work activities was associated with higher odds of myopia (odds ratio [OR] = 1.14; 95% confidence interval [CI] = 1.08–1.20) and that the odds of myopia increased by 2% (OR:1.02; 95% CI = 1.01–1.03) for every one diopter-hour (hr) more of near work per week. Therefore, the development of a strategy to reduce the impact of near work on myopia would be important for preventing myopia in children. PMID:26485393

  15. The Association between Near Work Activities and Myopia in Children-A Systematic Review and Meta-Analysis.

    PubMed

    Huang, Hsiu-Mei; Chang, Dolly Shuo-Teh; Wu, Pei-Chang

    2015-01-01

    Myopia has a multifactorial etiology, although environmental factors are predominant in determining its current patterns. Currently, associations between near work activities and myopia have not been consistently observed. Therefore, we performed a systematic review to quantify the effect of near work activities on myopia in children. Relevant articles published between 1989 and 2014 were identified in MEDLINE, Embase, and the Cochrane Library, and the citation lists were reviewed. Twelve cohort studies and 15 cross-sectional studies were included (25,025 children aged between 6 and 18 years). The I2 statistic was used to assess heterogeneity. Study-level data were pooled using a random-effects model or a fixed-effects model (when less than 5 studies were included). We found that more time spent on near work activities was associated with higher odds of myopia (odds ratio [OR] = 1.14; 95% confidence interval [CI] = 1.08-1.20) and that the odds of myopia increased by 2% (OR:1.02; 95% CI = 1.01-1.03) for every one diopter-hour (hr) more of near work per week. Therefore, the development of a strategy to reduce the impact of near work on myopia would be important for preventing myopia in children.

  16. Oxidized fish oil in rat pregnancy causes high newborn mortality and increases maternal insulin resistance.

    PubMed

    Albert, Benjamin B; Vickers, Mark H; Gray, Clint; Reynolds, Clare M; Segovia, Stephanie A; Derraik, José G B; Lewandowski, Paul A; Garg, Manohar L; Cameron-Smith, David; Hofman, Paul L; Cutfield, Wayne S

    2016-09-01

    Fish oil is commonly taken by pregnant women, and supplements sold at retail are often oxidized. Using a rat model, we aimed to assess the effects of supplementation with oxidized fish oil during pregnancy in mothers and offspring, focusing on newborn viability and maternal insulin sensitivity. Female rats were allocated to a control or high-fat diet and then mated. These rats were subsequently randomized to receive a daily gavage treatment of 1 ml of unoxidized fish oil, a highly oxidized fish oil, or control (water) throughout pregnancy. At birth, the gavage treatment was stopped, but the same maternal diets were fed ad libitum throughout lactation. Supplementation with oxidized fish oil during pregnancy had a marked adverse effect on newborn survival at day 2, leading to much greater odds of mortality than in the control (odds ratio 8.26) and unoxidized fish oil (odds ratio 13.70) groups. In addition, maternal intake of oxidized fish oil during pregnancy led to increased insulin resistance at the time of weaning (3 wks after exposure) compared with control dams (HOMA-IR 2.64 vs. 1.42; P = 0.044). These data show that the consumption of oxidized fish oil is harmful in rat pregnancy, with deleterious effects in both mothers and offspring. Copyright © 2016 the American Physiological Society.

  17. Allergies and risk of pancreatic cancer: a pooled analysis from the Pancreatic Cancer Case-Control Consortium.

    PubMed

    Olson, Sara H; Hsu, Meier; Satagopan, Jaya M; Maisonneuve, Patrick; Silverman, Debra T; Lucenteforte, Ersilia; Anderson, Kristin E; Borgida, Ayelet; Bracci, Paige M; Bueno-de-Mesquita, H Bas; Cotterchio, Michelle; Dai, Qi; Duell, Eric J; Fontham, Elizabeth H; Gallinger, Steven; Holly, Elizabeth A; Ji, Bu-Tian; Kurtz, Robert C; La Vecchia, Carlo; Lowenfels, Albert B; Luckett, Brian; Ludwig, Emmy; Petersen, Gloria M; Polesel, Jerry; Seminara, Daniela; Strayer, Lori; Talamini, Renato

    2013-09-01

    In order to quantify the risk of pancreatic cancer associated with history of any allergy and specific allergies, to investigate differences in the association with risk according to age, gender, smoking status, or body mass index, and to study the influence of age at onset, we pooled data from 10 case-control studies. In total, there were 3,567 cases and 9,145 controls. Study-specific odds ratios and 95% confidence intervals were calculated by using unconditional logistic regression adjusted for age, gender, smoking status, and body mass index. Between-study heterogeneity was assessed by using the Cochran Q statistic. Study-specific odds ratios were pooled by using a random-effects model. The odds ratio for any allergy was 0.79 (95% confidence interval (CI): 0.62, 1.00) with heterogeneity among studies (P < 0.001). Heterogeneity was attributable to one study; with that study excluded, the pooled odds ratio was 0.73 (95% CI: 0.64, 0.84) (Pheterogeneity = 0.23). Hay fever (odds ratio = 0.74, 95% CI: 0.56, 0.96) and allergy to animals (odds ratio = 0.62, 95% CI: 0.41, 0.94) were related to lower risk, while there was no statistically significant association with other allergies or asthma. There were no major differences among subgroups defined by age, gender, smoking status, or body mass index. Older age at onset of allergies was slightly more protective than earlier age.

  18. Allergies and Risk of Pancreatic Cancer: A Pooled Analysis From the Pancreatic Cancer Case-Control Consortium

    PubMed Central

    Olson, Sara H.; Hsu, Meier; Satagopan, Jaya M.; Maisonneuve, Patrick; Silverman, Debra T.; Lucenteforte, Ersilia; Anderson, Kristin E.; Borgida, Ayelet; Bracci, Paige M.; Bueno-de-Mesquita, H. Bas; Cotterchio, Michelle; Dai, Qi; Duell, Eric J.; Fontham, Elizabeth H.; Gallinger, Steven; Holly, Elizabeth A.; Ji, Bu-Tian; Kurtz, Robert C.; La Vecchia, Carlo; Lowenfels, Albert B.; Luckett, Brian; Ludwig, Emmy; Petersen, Gloria M.; Polesel, Jerry; Seminara, Daniela; Strayer, Lori; Talamini, Renato

    2013-01-01

    In order to quantify the risk of pancreatic cancer associated with history of any allergy and specific allergies, to investigate differences in the association with risk according to age, gender, smoking status, or body mass index, and to study the influence of age at onset, we pooled data from 10 case-control studies. In total, there were 3,567 cases and 9,145 controls. Study-specific odds ratios and 95% confidence intervals were calculated by using unconditional logistic regression adjusted for age, gender, smoking status, and body mass index. Between-study heterogeneity was assessed by using the Cochran Q statistic. Study-specific odds ratios were pooled by using a random-effects model. The odds ratio for any allergy was 0.79 (95% confidence interval (CI): 0.62, 1.00) with heterogeneity among studies (P < 0.001). Heterogeneity was attributable to one study; with that study excluded, the pooled odds ratio was 0.73 (95% CI: 0.64, 0.84) (Pheterogeneity = 0.23). Hay fever (odds ratio = 0.74, 95% CI: 0.56, 0.96) and allergy to animals (odds ratio = 0.62, 95% CI: 0.41, 0.94) were related to lower risk, while there was no statistically significant association with other allergies or asthma. There were no major differences among subgroups defined by age, gender, smoking status, or body mass index. Older age at onset of allergies was slightly more protective than earlier age. PMID:23820785

  19. The Effectiveness of SMS Reminders on Appointment Attendance: a Meta-Analysis.

    PubMed

    Boksmati, Nasim; Butler-Henderson, Kerryn; Anderson, Kevin; Sahama, Tony

    2016-04-01

    To identify the efficacy of short message service (SMS) reminders in health care appointment attendance. A systematic review was undertaken to identify studies published between 2005 and 2015 that compared the attendance rates of patients receiving SMS reminders compared to patients not receiving a reminder. Each article was examined for information regarding the study design, sample size, population demographics and intervention methods. A meta-analysis was used to calculate a pooled estimate odds ratio. Twenty-eight (28) studies were included in the review, including 13 (46 %) randomized controlled trials. The pooled odds ratio of the randomized control trials was 1.62 (1.35-1.94). Half of the studies reviewed sent the reminder within 48 h prior to the appointment time, yet no significant subgroups differences with respect to participant age, SMS timing, rate or type, setting or specialty was detectable. All studies, except one with a small sample size, demonstrated a positive OR, indicating SMS reminders were an effective means of improving appointment attendance. There was no significant difference in OR when controlling for when the SMS was sent, the frequency of the reminders or the content of the reminder. SMS appointment reminders are an effective and operative method in improving appointment attendance in a health care setting and this effectiveness has improved over the past 5 years. Further research is required to identify the optimal SMS reminder timing and frequency, specifically in relation to the length of time since the appointment.

  20. Cryopreservation of human embryos by vitrification or slow freezing: which one is better?

    PubMed

    Kolibianakis, Efstratios M; Venetis, Christos A; Tarlatzis, Basil C

    2009-06-01

    To summarize the available evidence from randomized controlled trials comparing vitrification versus slow freezing for cryopreservation of human embryos. Vitrification, as compared with slow freezing, appears to be better in terms of postthawing survival rates both for cleavage-stage embryos [odds ratio (OR): 6.35, 95% confidence interval (CI): 1.14-35.26, random effects model] and for blastocysts (OR: 4.09, 95% CI: 2.45-6.84, random effects model). Furthermore, postthawing blastocyst development of embryos cryopreserved in the cleavage stage is significantly higher with vitrification as compared with slow freezing (OR: 1.56, 95% CI: 1.07-2.27, fixed effects model). No significant difference in clinical pregnancy rates per transfer could be detected between the two cryopreservation methods (OR: 1.66, 95% CI: 0.98-2.79). Currently, vitrification does not appear to be associated with an increased probability of pregnancy. However, a significant advantage of vitrification over slow freezing in terms of postthawing survival rates is present for embryos cryopreserved both at the cleavage and at the blastocyst stages. The above conclusions are based on limited data, and thus further properly designed randomized controlled trials are needed.

  1. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

    PubMed

    McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

    2014-11-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

    2014-01-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

  3. Risk of Myocardial Infarction in Patients with Long-Term Non-Vitamin K Antagonist Oral Anticoagulant Treatment.

    PubMed

    Tornyos, Adrienn; Kehl, Dániel; D'Ascenzo, Fabrizio; Komócsi, András

    2016-01-01

    The relative cardiovascular (CV) safety of oral anticoagulants continues to be debated, and in particular concerns for risk of myocardial infarction (MI) have been raised. We analyzed the risk of MI in patients treated long term with oral anticoagulants (vitamin K antagonists [VKA], direct thrombin inhibitors or activated X factor antagonist) for atrial fibrillation, deep vein thrombosis or pulmonary embolism using a network meta-analysis (NMA). Randomized, phase 3 trials comparing novel anticoagulants to VKA were searched. Information on study design and clinical outcomes was extracted. The primary end-point of the analysis was the occurrence of MI or acute coronary syndrome. A Bayesian multiple treatment analysis was performed using fixed-effect and random-effects modeling. Twelve trials including 100,524 randomized patients were analyzed. The odds for MI in NMA were worse with dabigatran when compared to VKA, rivaroxaban, apixaban, and edoxaban (OR: 0.66 CI: 0.49-0.87; OR: 0.56 CI: 0.38-0.82, OR: 0.59 CI 0.40-0.88, and OR: 0.71 CI: 0.50-1.0, respectively).The posterior probability of being the first best choice of treatment was 53.5% for rivaroxaban, 33.8% for apixaban, 9.5% for ximelagatran, 2.0% for edoxaban, 1.2% for VKA, and 0.007% for dabigatran. There is a considerable heterogeneity regarding CV safety among oral anticoagulants. Differences in risk of MI may influence the choice of treatment. Multiple treatment NMA found 29%-44% higher odds of MI with dabigatran supporting the concerns regarding its CV safety. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Transabdominal amnioinfusion for preterm premature rupture of membranes: a systematic review and metaanalysis of randomized and observational studies.

    PubMed

    Porat, Shay; Amsalem, Hagai; Shah, Prakesh S; Murphy, Kellie E

    2012-11-01

    The purpose of this study was to review systematically the efficacy of transabdominal amnioinfusion (TA) in early preterm premature rupture of membranes (PPROM). We conducted a literature search of EMBASE, MEDLINE, and ClinicalTrials.gov databases and identified studies in which TA was used in cases of proven PPROM and oligohydramnios. Risk of bias was assessed for observational studies and randomized controlled trials. Primary outcomes were latency period and perinatal mortality rates. Four observational studies (n = 147) and 3 randomized controlled trials (n = 165) were eligible. Pooled latency period was 14.4 (range, 8.2-20.6) and 11.41 (range -3.4 to 26.2) days longer in the TA group in the observational and the randomized controlled trials, respectively. Perinatal mortality rates were reduced among the treatment groups in both the observational studies (odds ratio, 0.12; 95% confidence interval, 0.02-0.61) and the randomized controlled trials (odds ratio, 0.33; 95% confidence interval, 0.10-1.12). Serial TA for early PPROM may improve early PPROM-associated morbidity and mortality rates. Additional adequately powered randomized control trials are needed. Copyright © 2012 Mosby, Inc. All rights reserved.

  5. Complementary nonparametric analysis of covariance for logistic regression in a randomized clinical trial setting.

    PubMed

    Tangen, C M; Koch, G G

    1999-03-01

    In the randomized clinical trial setting, controlling for covariates is expected to produce variance reduction for the treatment parameter estimate and to adjust for random imbalances of covariates between the treatment groups. However, for the logistic regression model, variance reduction is not obviously obtained. This can lead to concerns about the assumptions of the logistic model. We introduce a complementary nonparametric method for covariate adjustment. It provides results that are usually compatible with expectations for analysis of covariance. The only assumptions required are based on randomization and sampling arguments. The resulting treatment parameter is a (unconditional) population average log-odds ratio that has been adjusted for random imbalance of covariates. Data from a randomized clinical trial are used to compare results from the traditional maximum likelihood logistic method with those from the nonparametric logistic method. We examine treatment parameter estimates, corresponding standard errors, and significance levels in models with and without covariate adjustment. In addition, we discuss differences between unconditional population average treatment parameters and conditional subpopulation average treatment parameters. Additional features of the nonparametric method, including stratified (multicenter) and multivariate (multivisit) analyses, are illustrated. Extensions of this methodology to the proportional odds model are also made.

  6. Efficacy and safety of recombinant activated factor vii in major surgical procedures: systematic review and meta-analysis of randomized clinical trials.

    PubMed

    Ranucci, Marco; Isgrò, Giuseppe; Soro, Giorgio; Conti, Daniela; De Toffol, Barbara

    2008-03-01

    To investigate the efficacy and safety of recombinant activated factor VII (rFVIIa) treatment in patients undergoing major surgical procedures. Relevant studies were searched in BioMedCentral, CENTRAL, PubMed, and PubMed Central. Only randomized controlled trials on humans undergoing major surgery were included. Efficacy was determined as the rate of patients receiving allogeneic packed red blood cells; safety was assessed in terms of thromboembolic complications and mortality rate. We followed the Cochrane Collaboration method for data extraction and internal validity procedures, as well as the Quality of Reporting of Meta-analyses statement. Seven randomized controlled trials met the inclusion criteria. Treatment with rFVIIa is associated with a reduced risk of receiving allogeneic packed red blood cells (odds ratio, 0.29; 95% confidence interval, 0.10-0.80). In a subgroup analysis, only patients receiving at least 50 mug/kg of rFVIIa had a significant benefit (odds ratio, 0.43; 95% confidence interval, 0.23-0.78). No differences in thromboembolic complications and mortality rates were observed. Treatment with rFVIIa is effective in reducing the rate of patients undergoing transfusion with allogeneic packed red blood cells. However, the cost-benefit ratio is favorable only in patients who need a huge number of packed red blood cell units. No safety concerns arise from the present study.

  7. Prophylactic intra-peritoneal drain placement following pancreaticoduodenectomy: A systematic review and meta-analysis

    PubMed Central

    Wang, Yi-Chao; Szatmary, Peter; Zhu, Jing-Qiang; Xiong, Jun-Jie; Huang, Wei; Gomatos, Ilias; Nunes, Quentin M; Sutton, Robert; Liu, Xu-Bao

    2015-01-01

    AIM: To conduct a meta-analysis comparing outcomes after pancreaticoduodenectomy (PD) with or without prophylactic drainage. METHODS: Relevant comparative randomized and non-randomized studies were systemically searched based on specific inclusion and exclusion criteria. Postoperative outcomes were compared between patients with and those without routine drainage. Pooled odds ratios (OR) with 95%CI were calculated using either fixed effects or random effects models. RESULTS: One randomized controlled trial and four non-randomized comparative studies recruiting 1728 patients were analyzed. Patients without prophylactic drainage after PD had significantly higher mortality (OR = 2.32, 95%CI: 1.11-4.85; P = 0.02), despite the fact that they were associated with fewer overall complications (OR = 0.62, 95%CI: 0.48-0.82; P = 0.00), major complications (OR = 0.75, 95%CI: 0.60-0.93; P = 0.01) and readmissions (OR = 0.77, 95%CI: 0.60-0.98; P = 0.04). There were no significant differences in the rates of pancreatic fistula, intra-abdominal abscesses, postpancreatectomy hemorrhage, biliary fistula, delayed gastric emptying, reoperation or radiologic-guided drains between the two groups. CONCLUSION: Indiscriminate abandonment of intra-abdominal drainage following PD is associated with greater mortality, but lower complication rates. Future randomized trials should compare routine vs selective drainage. PMID:25741162

  8. Does marital status predict the odds of suicidal death in taiwan? A seven-year population-based study.

    PubMed

    Yeh, Jui-Yuan; Xirasagar, Sudha; Liu, Tsai-Ching; Li, Chong-Yi; Lin, Herng-Ching

    2008-06-01

    Using nationwide, 7-year population-based data for 1997-2003, we examined marital status to see if it predicted suicide among the ethnic Chinese population of Taiwan. Using cause of death data, with a case-control design, two groups-total adult suicide deaths, n = 17,850, the study group, and adult deaths other than suicide, n = 71,400 (randomly selected from age, sex, and geographic region matched controls, four per suicide)-were studied. Using multiple logistic regression analysis including age-marital status interaction, adjusted estimates show divorced status to be the most detrimental for suicide propensity, with males showing stronger effect size. Females never married, aged below 35 and 65-plus, and widowed 65-plus had lower suicide odds.

  9. Personally addressed hand-signed letters increase questionnaire response: a meta-analysis of randomised controlled trials

    PubMed Central

    Scott, Pippa; Edwards, Phil

    2006-01-01

    Background Postal questionnaires are commonly used to collect data for health studies, but non-response reduces study sample sizes and can introduce bias. Finding ways to increase the proportion of questionnaires returned would improve research quality. We sought to quantify the effect on response when researchers address participants personally by name on letters that accompany questionnaires. Methods All randomised controlled trials in a published systematic review that evaluated the effect on response of including participants' names on letters that accompany questionnaires were included. Odds ratios for response were pooled in a random effects meta-analysis and evidence for changes in effects over time was assessed using random effects meta-regression. Results Fourteen randomised controlled trials were included covering a wide range of topics. Most topics were unrelated to health or social care. The odds of response when including participants' names on letters were increased by one-fifth (pooled OR 1.18, 95% CI 1.03 to 1.34; p = 0.015). When participants' names and hand-written signatures were used in combination, the effect was a more substantial increase in response (OR 1.45, 95% CI 1.27 to 1.66; p < 0.001), corresponding to an absolute increase in the proportion of questionnaires returned of between 4% and 10%, depending on the baseline response rate. There was no evidence that the magnitude of these effects had declined over time. Conclusion This meta-analysis of the best available evidence indicates that researchers using postal questionnaires can increase response by addressing participants by name on cover letters. The effect appears to be enhanced by including hand-written signatures. PMID:16953871

  10. Paraprofessional-delivered home-visiting intervention for American Indian teen mothers and children: 3-year outcomes from a randomized controlled trial.

    PubMed

    Barlow, Allison; Mullany, Britta; Neault, Nicole; Goklish, Novalene; Billy, Trudy; Hastings, Ranelda; Lorenzo, Sherilynn; Kee, Crystal; Lake, Kristin; Redmond, Cleve; Carter, Alice; Walkup, John T

    2015-02-01

    The Affordable Care Act provides funding for home-visiting programs to reduce health care disparities, despite limited evidence that existing programs can overcome implementation and evaluation challenges with at-risk populations. The authors report 36-month outcomes of the paraprofessional-delivered Family Spirit home-visiting intervention for American Indian teen mothers and children. Expectant American Indian teens (N=322, mean age=18.1 years) from four southwestern reservation communities were randomly assigned to the Family Spirit intervention plus optimized standard care or optimized standard care alone. Maternal and child outcomes were evaluated at 28 and 36 weeks gestation and 2, 6, 12, 18, 24, 30, and 36 months postpartum. At baseline the mothers had high rates of substance use (>84%), depressive symptoms (>32%), dropping out of school (>57%), and residential instability (51%). Study retention was ≥83%. From pregnancy to 36 months postpartum, mothers in the intervention group had significantly greater parenting knowledge (effect size=0.42) and parental locus of control (effect size=0.17), fewer depressive symptoms (effect size=0.16) and externalizing problems (effect size=0.14), and lower past month use of marijuana (odds ratio=0.65) and illegal drugs (odds ratio=0.67). Children in the intervention group had fewer externalizing (effect size=0.23), internalizing (effect size=0.23), and dysregulation (effect size=0.27) problems. The paraprofessional home-visiting intervention promoted effective parenting, reduced maternal risks, and improved child developmental outcomes in the U.S. population subgroup with the fewest resources and highest behavioral health disparities. The methods and results can inform federal efforts to disseminate and sustain evidence-based home-visiting interventions in at-risk populations.

  11. Seventeen-year evaluation of breast cancer screening: the DOM project, The Netherlands. Diagnostisch Onderzoek (investigation) Mammacarcinoom.

    PubMed Central

    Miltenburg, G. A.; Peeters, P. H.; Fracheboud, J.; Collette, H. J.

    1998-01-01

    The DOM project is a non-randomized population-based breast cancer screening programme in Utrecht which started in 1974-75. The 17-year effect has been evaluated by a case-control study of breast cancer deaths during the period 1975-92 in women living in the city of Utrecht, born between 1911 and 1925, whose breast cancers were diagnosed after the initiation of the DOM project. Controls (three for each case) were defined as women having the same year of birth as the case, living in the city of Utrecht at the time the case died, and having had the opportunity of screening in the DOM project. Screening in the period 1975-92 indicated a breast cancer mortality reduction of 46% (odds ratio of 0.54, 95% confidence interval 0.37-0.79). The strongest protective effect was found at a screening interval of 2 years or less (mortality reduction of 62%, odds ratio of 0.38), and for the highest number of screens (mortality reduction of 68%, odds ratio of 0.32 for more than four screens). Exclusion of breast cancer deaths that occurred within 1 year of diagnosis, to allow for 'lead-time' bias, gave an odds ratio of 0.61. Early diagnosis of breast cancer by screening reduces breast cancer mortality in the long term. Bias due to the study design may slightly overestimate the protective effect. A screening programme with a 2-yearly, or smaller, interval between successive screens will improve the protection of screening. PMID:9764591

  12. Mobile phone use and risk of tumors: a meta-analysis.

    PubMed

    Myung, Seung-Kwon; Ju, Woong; McDonnell, Diana D; Lee, Yeon Ji; Kazinets, Gene; Cheng, Chih-Tao; Moskowitz, Joel M

    2009-11-20

    Case-control studies have reported inconsistent findings regarding the association between mobile phone use and tumor risk. We investigated these associations using a meta-analysis. We searched MEDLINE (PubMed), EMBASE, and the Cochrane Library in August 2008. Two evaluators independently reviewed and selected articles based on predetermined selection criteria. Of 465 articles meeting our initial criteria, 23 case-control studies, which involved 37,916 participants (12,344 patient cases and 25,572 controls), were included in the final analyses. Compared with never or rarely having used a mobile phone, the odds ratio for overall use was 0.98 for malignant and benign tumors (95% CI, 0.89 to 1.07) in a random-effects meta-analysis of all 23 studies. However, a significant positive association (harmful effect) was observed in a random-effects meta-analysis of eight studies using blinding, whereas a significant negative association (protective effect) was observed in a fixed-effects meta-analysis of 15 studies not using blinding. Mobile phone use of 10 years or longer was associated with a risk of tumors in 13 studies reporting this association (odds ratio = 1.18; 95% CI, 1.04 to 1.34). Further, these findings were also observed in the subgroup analyses by methodologic quality of study. Blinding and methodologic quality of study were strongly associated with the research group. The current study found that there is possible evidence linking mobile phone use to an increased risk of tumors from a meta-analysis of low-biased case-control studies. Prospective cohort studies providing a higher level of evidence are needed.

  13. The Impact of a School-Based Hygiene, Water Quality and Sanitation Intervention on Soil-Transmitted Helminth Reinfection: A Cluster-Randomized Trial

    PubMed Central

    Freeman, Matthew C.; Clasen, Thomas; Brooker, Simon J.; Akoko, Daniel O.; Rheingans, Richard

    2013-01-01

    We conducted a cluster-randomized trial to assess the impact of a school-based water treatment, hygiene, and sanitation program on reducing infection with soil-transmitted helminths (STHs) after school-based deworming. We assessed infection with STHs at baseline and then at two follow-up rounds 8 and 10 months after deworming. Forty government primary schools in Nyanza Province, Kenya were randomly selected and assigned to intervention or control arms. The intervention reduced reinfection prevalence (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.31–1.00) and egg count (rate ratio [RR] 0.34, CI 0.15–0.75) of Ascaris lumbricoides. We found no evidence of significant intervention effects on the overall prevalence and intensity of Trichuris trichiura, hookworm, or Schistosoma mansoni reinfection. Provision of school-based sanitation, water quality, and hygiene improvements may reduce reinfection of STHs after school-based deworming, but the magnitude of the effects may be sex- and helminth species-specific. PMID:24019429

  14. Achieving Drug and Alcohol Abstinence Among Recently Incarcerated Homeless Women: A Randomized Controlled Trial Comparing Dialectical Behavioral Therapy-Case Management With a Health Promotion Program.

    PubMed

    Nyamathi, Adeline M; Shin, Sanghyuk S; Smeltzer, Jolene; Salem, Benissa E; Yadav, Kartik; Ekstrand, Maria L; Turner, Susan F; Faucette, Mark

    Homeless female ex-offenders (homeless female offenders) exiting jail and prison are at a critical juncture during reentry and transitioning into the community setting. The purpose of the study was to compare the effect of a dialectical behavioral therapy-case management (DBT-CM) program with a health promotion (HP) program on achieving drug and alcohol abstinence among female parolees/probationers residing in the community. We conducted a multicenter parallel randomized controlled trial with 130 female parolees/probationers (aged 19-64 years) residing in the community randomly assigned to either DBT-CM (n = 65) or HP (n = 65). The trial was conducted in four community-based partner sites in Los Angeles and Pomona, California, from February 2015 to November 2016. Treatment assignment was carried out using a computer-based urn randomization program. The primary outcome was drug and alcohol use abstinence at 6-month follow up. Analysis was based on data from 116 participants with complete outcome data. Multivariable logistic regression revealed that the DBT-CM program remained an independent positive predictor of decrease in drug use among the DBT-CM participants at 6 months (p = .01) as compared with the HP program participants. Being non-White (p < .05) and having higher depressive symptom scores (p < .05) were associated with lower odds of drug use abstinence (i.e., increased the odds of drug use) at 6 months. DBT-CM increased drug and alcohol abstinence at 6-month follow-up, compared to an HP program.

  15. Effect of the Planet Health Intervention on Eating Disorder Symptoms in Massachusetts Middle Schools, 2005–2008

    PubMed Central

    Spadano-Gasbarro, Jennifer L.; Greaney, Mary L.; Blood, Emily A.; Hunt, Anne T.; Richmond, Tracy K.; Wang, Monica L.; Mezgebu, Solomon; Osganian, Stavroula K.; Peterson, Karen E.

    2012-01-01

    Introduction The Planet Health obesity prevention curriculum has prevented purging and abuse of diet pills (disordered weight control behavior [DWCB]) in middle-school girls in randomized trials, but the effects of Planet Health on DWCB when implemented by schools under dissemination conditions are not known. Methods Massachusetts Department of Public Health and Blue Cross Blue Shield of Massachusetts disseminated Planet Health as part of the 3-year, Healthy Choices obesity prevention program in middle schools. We conducted an evaluation in 45 schools from fall 2005 to spring 2008. We gathered data from school staff to quantify intervention activities, and we gathered anonymous cross-sectional survey data from students on DWCB at baseline and Year 3 follow-up (n = 16,369). Multivariate logistic analyses with generalized estimating equations examined the effect of intervention activities on odds of students reporting DWCB at follow-up. Results Students in schools reaching a high number of youth with Planet Health lessons on reducing television viewing had lower odds of DWCB at follow-up (odds ratio [OR], 0.80 per 100 lesson-exposures; 95% confidence interval [CI], 0.74–0.85). In addition, reduced odds of DWCB at follow-up were found in schools with active staff teamwork (OR, 0.76; 95% CI, 0.66–0.86) and the presence of programs addressing television viewing goals with staff (OR, 0.38; 95% CI, 0.28–0.53). Conclusion Combined evidence from efficacy and effectiveness trials and now from dissemination research indicates that appropriately designed obesity prevention programs can achieve DWCB prevention on a large scale. PMID:23194779

  16. Does peer use influence adoption of efficient cookstoves? Evidence from a randomized controlled trial in Uganda.

    PubMed

    Beltramo, Theresa; Blalock, Garrick; Levine, David I; Simons, Andrew M

    2015-01-01

    The authors examined the effect of peer usage on consumer demand for efficient cookstoves with a randomized controlled trial in rural Uganda. The authors tested whether the neighbors of buyers who ordered and received a stove are more likely to purchase an efficient cookstove than the neighbors of buyers who ordered but have not yet received a stove. The authors found that neighbors of buyers who have experience with the stove are not detectably more likely to purchase a stove than neighbors of buyers who have not yet received their stove. The authors found evidence of peer effects in opinions about efficient cookstoves. Knowing that a prominent member of the community has the efficient stove predicts 17-22 percentage points higher odds of strongly favoring the stove. However, this more favorable opinion seemingly has no effect on purchase decisions.

  17. A randomized trial of mailed questionnaires versus telephone interviews: Response patterns in a survey

    PubMed Central

    Feveile, Helene; Olsen, Ole; Hogh, Annie

    2007-01-01

    Background Data for health surveys are often collected using either mailed questionnaires, telephone interviews or a combination. Mode of data collection can affect the propensity to refuse to respond and result in different patterns of responses. The objective of this paper is to examine and quantify effects of mode of data collection in health surveys. Methods A stratified sample of 4,000 adults residing in Denmark was randomised to mailed questionnaires or computer-assisted telephone interviews. 45 health-related items were analyzed; four concerning behaviour and 41 concerning self assessment. Odds ratios for more positive answers and more frequent use of extreme response categories (both positive and negative) among telephone respondents compared to questionnaire respondents were estimated. Tests were Bonferroni corrected. Results For the four health behaviour items there were no significant differences in the response patterns. For 32 of the 41 health self assessment items the response pattern was statistically significantly different and extreme response categories were used more frequently among telephone respondents (Median estimated odds ratio: 1.67). For a majority of these mode sensitive items (26/32), a more positive reporting was observed among telephone respondents (Median estimated odds ratio: 1.73). The overall response rate was similar among persons randomly assigned to questionnaires (58.1%) and to telephone interviews (56.2%). A differential nonresponse bias for age and gender was observed. The rate of missing responses was higher for questionnaires (0.73 – 6.00%) than for telephone interviews (0 – 0.51%). The "don't know" option was used more often by mail respondents (10 – 24%) than by telephone respondents (2 – 4%). Conclusion The mode of data collection affects the reporting of self assessed health items substantially. In epidemiological studies, the method effect may be as large as the effects under investigation. Caution is needed when comparing prevalences across surveys or when studying time trends. PMID:17592653

  18. Development of Alive! (A Lifestyle Intervention Via Email), and Its Effect on Health-related Quality of Life, Presenteeism, and Other Behavioral Outcomes: Randomized Controlled Trial

    PubMed Central

    Sternfeld, Barbara; Block, Clifford H; Block, Torin J; Norris, Jean; Hopkins, Donald; Quesenberry, Charles P; Husson, Gail; Clancy, Heather Anne

    2008-01-01

    Background Cost-effective interventions to improve diet and physical activity are a public health priority. Alive! is an email-based intervention to increase physical activity, reduce saturated and trans fats and added sugars, and increase fruit and vegetable consumption. It was shown to improve these behaviors in a large randomized controlled trial. Objective (1) To describe the components and behavioral principles underlying Alive!, and (2) to report effects of the intervention on the secondary outcomes: health-related quality of life, presenteeism, self-efficacy, and stage of change. Methods The Alive! behavior change model is designed to elicit healthy behaviors and promote their maintenance. Behavioral strategies include assessments followed by individualized feedback, weekly goal-setting, individually tailored goals and tips, reminders, and promotion of social support. Alive! was tested among non-medical employees of Kaiser Permanente of Northern California, who were randomized to either the intervention group or the wait-list control group. After randomization, intervention group participants chose one topic to undertake for the intervention period: increasing physical activity, increasing fruits and vegetables, or decreasing saturated and trans fats and added sugars. Pre-post questionnaires assessed changes in SF-8 health-related quality of life, presenteeism, self-efficacy, and stage of change. Mixed effects multiple linear regression and ordinal logistic regression models were used, with department as a random effect factor. Analyses were by intention to treat: the 30% (238/787) who did not respond to the follow-up questionnaires were assigned change scores of zero. Results Participants were 19 to 65 years (mean 44.0 +/- 10.6), and 74.3% (585/787) were female. Mean SF-8 Physical quality of life score increased significantly more in the intervention group than in the control group, 1.84 (95% CI 0.96-2.72) vs 0.72 (95% CI -0.15-1.58) respectively, P = .02. SF8 Mental score also improved significantly more in the intervention group than in the control group (P = .02). The odds ratio for improvement in self-assessed health status was 1.57 (95% CI 1.21-2.04, P < .001) for the intervention group compared to the control group. The odds ratio for having a reduction in difficulty accomplishing work tasks because of physical or emotional problems, a measure of presenteeism, was 1.47 (95% CI 1.05-2.05, P = .02) for the intervention group compared to the control group. The odds of having an improvement in self-efficacy for changing diet was 2.05 (95% CI 1.44-2.93) for the intervention vs the control group (P < .001). Greater improvement in stage of change for physical activity (P = .05), fats (P = .06), and fruits/vegetables (P = .006) was seen in the intervention group compared to the control group. Significant effects on diet and physical activity behavior change are reported elsewhere. Conclusions Cost-effective methods that can reach large populations with science-based interventions are urgently needed. Alive! is a fully automated low-cost intervention shown to effect significant improvements in important health parameters. Trial Registration Clinicaltrials.gov NCT00607009; http://clinicaltrials.gov/ct2/show/NCT00607009 (Archived by WebCite at http://www.webcitation.org/5cLpCWcT6) PMID:19019818

  19. Inference for binomial probability based on dependent Bernoulli random variables with applications to meta‐analysis and group level studies

    PubMed Central

    Bakbergenuly, Ilyas; Morgenthaler, Stephan

    2016-01-01

    We study bias arising as a result of nonlinear transformations of random variables in random or mixed effects models and its effect on inference in group‐level studies or in meta‐analysis. The findings are illustrated on the example of overdispersed binomial distributions, where we demonstrate considerable biases arising from standard log‐odds and arcsine transformations of the estimated probability p^, both for single‐group studies and in combining results from several groups or studies in meta‐analysis. Our simulations confirm that these biases are linear in ρ, for small values of ρ, the intracluster correlation coefficient. These biases do not depend on the sample sizes or the number of studies K in a meta‐analysis and result in abysmal coverage of the combined effect for large K. We also propose bias‐correction for the arcsine transformation. Our simulations demonstrate that this bias‐correction works well for small values of the intraclass correlation. The methods are applied to two examples of meta‐analyses of prevalence. PMID:27192062

  20. Emerging disparities in overweight by educational attainment in Chinese adults (1989-2006).

    PubMed

    Jones-Smith, J C; Gordon-Larsen, P; Siddiqi, A; Popkin, B M

    2012-06-01

    To test whether a disparity in overweight by socioeconomic status (SES; represented by educational attainment) has emerged among men or women during a recent 17-year period in China. Data from the China Health and Nutrition Survey (CHNS), a panel study including 7314 women and 6492 men, are used to longitudinally track the body mass index (BMI) and odds of overweight by educational attainment among Chinese adults (baseline age 18-50) from 1989 to 2006 to determine whether individuals of low (secondary school) educational attainment experienced a disproportionately faster increase in BMI or odds of overweight (BMI≥25) over time. The unadjusted mean BMI and prevalence of overweight by education are presented. Sex-stratified, random-effects models are used to estimate the associations, and interactions by birth cohort are included. Overweight prevalence doubled for women and tripled for men. In 1989, among women, the odds of overweight were not different for those of high versus those of low educational attainment; however, by 2006, the odds of overweight were significantly lower for those with the highest education in both the younger (odds ratio (OR) 0.22 (CI 0.11, 0.42)) and the older (OR 0.27 (CI 0.10, 0.72)) birth cohorts. The reverse trend is seen for men, who also begin with no difference in odds of overweight by SES, but by 2006, the OR for the highest versus the lowest education group was 3.4 (CI 1.82, 6.18). Over 17 years, low SES has become associated with higher BMI and odds of overweight among Chinese women, whereas high SES remains a risk factor for overweight among Chinese men.

  1. Mixed models approaches for joint modeling of different types of responses.

    PubMed

    Ivanova, Anna; Molenberghs, Geert; Verbeke, Geert

    2016-01-01

    In many biomedical studies, one jointly collects longitudinal continuous, binary, and survival outcomes, possibly with some observations missing. Random-effects models, sometimes called shared-parameter models or frailty models, received a lot of attention. In such models, the corresponding variance components can be employed to capture the association between the various sequences. In some cases, random effects are considered common to various sequences, perhaps up to a scaling factor; in others, there are different but correlated random effects. Even though a variety of data types has been considered in the literature, less attention has been devoted to ordinal data. For univariate longitudinal or hierarchical data, the proportional odds mixed model (POMM) is an instance of the generalized linear mixed model (GLMM; Breslow and Clayton, 1993). Ordinal data are conveniently replaced by a parsimonious set of dummies, which in the longitudinal setting leads to a repeated set of dummies. When ordinal longitudinal data are part of a joint model, the complexity increases further. This is the setting considered in this paper. We formulate a random-effects based model that, in addition, allows for overdispersion. Using two case studies, it is shown that the combination of random effects to capture association with further correction for overdispersion can improve the model's fit considerably and that the resulting models allow to answer research questions that could not be addressed otherwise. Parameters can be estimated in a fairly straightforward way, using the SAS procedure NLMIXED.

  2. Nationwide access to an Internet-based contingency management intervention to promote smoking cessation: A randomized controlled trial

    PubMed Central

    Dallery, Jesse; Raiff, Bethany R.; Kim, Sunny Jung; Marsch, Lisa A.; Stitzer, Maxine; Grabinski, Michael J.

    2016-01-01

    Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of Internet-based CM relative to an Internet-based monitoring and goal setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow ups. Setting USA. Participants Smokers (n=94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output (n=48; Abstinent Contingent Group, AC), or based on submitting CO samples (n=46, Submission Contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0–100mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups (odds ratio=4.4, 95% CI=1.6–12.3), but not at the 3- (29.2% AC and 19.6% SC, odds ratio=1.7, 95% CI=.6–4.4), or 6- (22.9% AC and 13.0% SC, odds ratio=2.0, 95% CI=.7–5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, odds ratio = 3.5, 95% CI=3.1–4.0; 43.4% AC and 24.6% SC, odds ratio = 2.3, 95% CI=1.6–3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3%–23.8%, x2=.75, p = .39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. Conclusions A contingency management/financial incentive program delivered via the Internet improved short-term abstinence rates compared with an internet program without the incentives. PMID:27923264

  3. Dietary magnesium intake and risk of metabolic syndrome: a meta-analysis

    PubMed Central

    Dibaba, D. T.; Xun, P.; Fly, A. D.; Yokota, K.; He, K.

    2014-01-01

    Aims To estimate quantitatively the association between dietary magnesium intake and risk of metabolic syndrome by combining the relevant published articles using meta-analysis. Methods We reviewed the relevant literature in PubMed and EMBASE published up until August 2013 and obtained additional information through Google or a hand search of the references in relevant articles. A random-effects or fixed-effects model, as appropriate, was used to pool the effect sizes on metabolic syndrome comparing individuals with the highest dietary magnesium intake with those having the lowest intake. The dose–response relationship was assessed for every 100-mg/day increment in magnesium intake and risk of metabolic syndrome. Result Six cross-sectional studies, including a total of 24 473 individuals and 6311 cases of metabolic syndrome, were identified as eligible for the meta-analysis. A weighted inverse association was found between dietary magnesium intake and the risk of metabolic syndrome (odds ratio 0.69, 95% CI 0.59, 0.81) comparing the highest with the lowest group. For every 100-mg/day increment in magnesium intake, the overall risk of having metabolic syndrome was lowered by 17% (odds ratio 0.83, 95% CI 0. 77, 0.89). Conclusion Findings from the present meta-analysis suggest that dietary magnesium intake is inversely associated with the prevalence of metabolic syndrome. Further studies, in particular well-designed longitudinal cohort studies and randomized placebo-controlled clinical trials, are warranted to provide solid evidence and to establish causal inference. PMID:24975384

  4. The association between prostatitis and prostate cancer. Systematic review and meta-analysis.

    PubMed

    Perletti, Gianpaolo; Monti, Elena; Magri, Vittorio; Cai, Tommaso; Cleves, Anne; Trinchieri, Alberto; Montanari, Emanuele

    2017-12-31

    The main outcome of this review was the association between a history of clinical chronic prostatitis (NIH category II or III) and a histologically confirmed diagnosis of prostate cancer. Crude odds ratios and 95% confidence intervals (CI) were calculated to analyze dichotomous data. For analysis of pooled data we adopted a random-effects model and the inverse variance weighing method. Heterogeneity was assessed by calculating the I2 value. Out of 2794 screened records, we retrieved 16 full-text articles written in English, reporting the data of 15 case-control studies, involving 422.943 patients. Pooled analysis resulted in a significant crude odds ratio of 1.83 (95% CI: 1.43 to 2.35; P < 0.00001). The total set of data showed considerable heterogeneity (I2 = 91%). Both the Egger's test and the Begg's test for funnel plot asymmetry did not reach statistical significance. The 'trim and fill' method applied to the funnel plot imputed 3 missing studies and the resulting adjusted estimate of the odds ratio was 2.12 (95% CI: 1.38 to 3.22). According to GRADE criteria, the overall quality of the meta-analysis data is low, mainly due to the presence of bias, confounders and extreme effect size outliers. Five among the included studies reported data assessed in 8015 African-American subjects. Pooled analysis resulted in a non-significant crude odds ratio of 1.59 (95% CI: 0.71 to 3.57; P = 0.26), and considerable heterogeneity (I2 = 90%). Meta-analysis of 15 case-control studies shows that a history of clinical chronic prostatitis can significantly increase the odds for prostate cancer in the general population, whereas such association in African-American individuals remains uncertain.

  5. The Pharmacological Management of Oppositional Behaviour, Conduct Problems, and Aggression in Children and Adolescents With Attention-Deficit Hyperactivity Disorder, Oppositional Defiant Disorder, and Conduct Disorder: A Systematic Review and Meta-Analysis. Part 2: Antipsychotics and Traditional Mood Stabilizers

    PubMed Central

    Pringsheim, Tamara; Hirsch, Lauren; Gardner, David; Gorman, Daniel A

    2015-01-01

    Objective: Attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD) are among the most common psychiatric diagnoses in childhood. Aggression and conduct problems are a major source of disability and a risk factor for poor long-term outcomes. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) of antipsychotics, lithium, and anticonvulsants for aggression and conduct problems in youth with ADHD, ODD, and CD. Each medication was given an overall quality of evidence rating based on the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Eleven RCTs of antipsychotics and 7 RCTs of lithium and anticonvulsants were included. There is moderate-quality evidence that risperidone has a moderate-to-large effect on conduct problems and aggression in youth with subaverage IQ and ODD, CD, or disruptive behaviour disorder not otherwise specified, with and without ADHD, and high-quality evidence that risperidone has a moderate effect on disruptive and aggressive behaviour in youth with average IQ and ODD or CD, with and without ADHD. Evidence supporting the use of haloperidol, thioridazine, quetiapine, and lithium in aggressive youth with CD is of low or very-low quality, and evidence supporting the use of divalproex in aggressive youth with ODD or CD is of low quality. There is very-low-quality evidence that carbamazepine is no different from placebo for the management of aggression in youth with CD. Conclusion: With the exception of risperidone, the evidence to support the use of antipsychotics and mood stabilizers is of low quality. PMID:25886656

  6. Meta-analysis of residential exposure to radon gas and lung cancer.

    PubMed Central

    Pavia, Maria; Bianco, Aida; Pileggi, Claudia; Angelillo, Italo F.

    2003-01-01

    OBJECTIVES: To investigate the relation between residential exposure to radon and lung cancer. METHODS: A literature search was performed using Medline and other sources. The quality of studies was assessed. Adjusted odds ratios with 95% confidence intervals (CI) for the risk of lung cancer among categories of levels of exposure to radon were extracted. For each study, a weighted log-linear regression analysis of the adjusted odds ratios was performed according to radon concentration. The random effect model was used to combine values from single studies. Separate meta-analyses were performed on results from studies grouped with similar characteristics or with quality scores above or equal to the median. FINDINGS: Seventeen case-control studies were included in the meta-analysis. Quality scoring for individual studies ranged from 0.45 to 0.77 (median, 0.64). Meta-analysis based on exposure at 150 Bq/m3 gave a pooled odds ratio estimate of 1.24 (95% CI, 1.11-1.38), which indicated a potential effect of residential exposure to radon on the risk of lung cancer. Pooled estimates of fitted odds ratios at several levels of randon exposure were all significantly different from unity--ranging from 1.07 at 50 Bq/m3 to 1.43 at 250 Bq/m3. No remarkable differences from the baseline analysis were found for odds ratios from sensitivity analyses of studies in which > 75% of eligible cases were recruited (1.12, 1.00-1.25) and studies that included only women (1.29, 1.04-1.60). CONCLUSION: Although no definitive conclusions may be drawn, our results suggest a dose-response relation between residential exposure to radon and the risk of lung cancer. They support the need to develop strategies to reduce human exposure to radon. PMID:14758433

  7. Association Between Inpatient Sleep Loss and Hyperglycemia of Hospitalization

    PubMed Central

    DePietro, Regina H.; Knutson, Kristen L.; Spampinato, Lisa; Anderson, Samantha L.; Meltzer, David O.; Van Cauter, Eve

    2017-01-01

    OBJECTIVE To determine whether inpatient sleep duration and efficiency are associated with a greater risk of hyperglycemia in hospitalized patients with and without diabetes. RESEARCH DESIGN AND METHODS In this retrospective analysis of a prospective cohort study, medical inpatients ≥50 years of age were interviewed, and their charts were reviewed to obtain demographic data and diagnosis. Using World Health Organization criteria, patients were categorized as having normal blood glucose, impaired fasting blood glucose, or hyperglycemia based on morning glucose from the electronic health record. Wrist actigraphy measured sleep. Multivariable ordinal logistic regression models, controlling for subject random effects, tested the association between inpatient sleep duration and proportional odds of hyperglycemia versus impaired fasting blood glucose or impaired fasting blood glucose versus normal blood glucose in hospitalized adults. RESULTS A total of 212 patients (60% female and 74% African American) were enrolled. Roughly one-third (73, 34%) had diabetes. Objective inpatient sleep measures did not differ between patients with or without diabetes. In ordinal logistic regression models, each additional hour of in-hospital sleep was associated with an 11% (odds ratio 0.89 [95% CI 0.80, 0.99]; P = 0.043) lower proportional odds of a higher glucose category the next morning (hyperglycemia vs. elevated and elevated vs. normal). Every 10% increase in sleep efficiency was associated with an 18% lower proportional odds of a higher glucose category (odds ratio 0.82 [95% CI 0.74, 0.89]; P < 0.001). CONCLUSIONS Among medical inpatients, both shorter sleep duration and worse sleep efficiency were independently associated with greater proportional odds of hyperglycemia and impaired fasting glucose. PMID:27903614

  8. Drug therapy for solitary cysticercus granuloma: a systematic review and meta-analysis.

    PubMed

    Otte, Willem M; Singla, Monika; Sander, Josemir W; Singh, Gagandeep

    2013-01-08

    The effectiveness of anthelminthic and corticosteroid drug therapy in parenchymal neurocysticercosis is well established. The treatment of parenchymal solitary cysticercus granuloma (SCG), however, remains controversial. We attempted to obtain a consistent estimate of the efficacy of anthelminthic and corticosteroid drug treatment in SCG. Randomized-controlled trials (RCTs) comparing rates of seizure freedom, granuloma resolution, and residual calcification in individuals with SCG treated with anthelminthic or corticosteroid drugs with those treated with antiepileptic drugs (AEDs) alone were systematically reviewed and quantified using fixed- or random-effects meta-analysis. Fifteen RCTs were identified for inclusion. Ten RCTs assigned 765 people with SCG to AED treatment with or without anthelminthic drug (albendazole) treatment. A further 5 RCTs assigned 457 people with SCG to AED treatment with or without corticosteroid drugs. Anthelminthic treatment was associated with significantly increased rates of seizure freedom (nonevent odds ratio: 2.45; 95% confidence interval: 1.49-4.03; p = 0.0004) and significantly higher rates of granuloma resolution (odds ratio: 2.09; 95% confidence interval: 1.41-3.00; p = 0.0003), but did not alter the risk of residual calcification. Corticosteroid treatment was not significantly associated with any outcome. Anthelminthic treatment with albendazole provides improved rates of seizure freedom and hastens resolution of the granuloma. The role of corticosteroid treatment remains uncertain. The benefits (or lack thereof in the case of corticosteroids) are consistent when measured across different time points after treatment.

  9. A breast health educational program for Chinese-American women: 3- to 12-month postintervention effect.

    PubMed

    Lee-Lin, Frances; Nguyen, Thuan; Pedhiwala, Nisreen; Dieckmann, Nathan; Menon, Usha

    2015-01-01

    To test the efficacy of a culturally targeted breast cancer screening educational program in increasing mammogram completion in Chinese-American immigrant women. Randomized controlled study. Chinese communities, Portland, Oregon. From April 2010 to September 2011, 300 women were randomized to receive a theory-based, culturally targeted breast cancer screening educational intervention (n = 147) or a mammography screening brochure published by the National Cancer Institute (n = 153). The two-part intervention consisted of group teaching with targeted, theory-based messages followed by individual counseling sessions. Mammography completion, perceived susceptibility, perceived benefits, perceived barriers, perceived cultural barriers, and demographic variables. A 2 × 3 mixed logistic model was applied to determine odds ratio of mammogram completion. Behavior changed in both groups, with a total of 170 participants (56.7%) reporting a mammogram at 12 months. The logistic model indicated increased odds of mammogram completion in the intervention compared to the control group at 3, 6, and 12 months. When controlling for marital status, age, and age moved to the United States, the intervention group was nine times more likely to complete mammograms than the control group. The culturally targeted educational program significantly increased mammogram use among Chinese immigrant women. Further testing of effectiveness in larger community settings is needed. The intervention may also serve as a foundation from which to develop education to increase cancer screening among other minority subgroups.

  10. Late Postoperative Complications in Laparoscopic Sleeve Gastrectomy (LVSG) Versus Laparoscopic Roux-en-y Gastric Bypass (LRYGB): Meta-analysis and Systematic Review.

    PubMed

    Osland, Emma; Yunus, Rossita M; Khan, Shahjahan; Memon, Breda; Memon, Muhammed A

    2016-06-01

    Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic vertical sleeve gastrectomy (LVSG), have been proposed as cost-effective strategies to manage obesity-related chronic disease. The objectives of this meta-analysis and systematic review were to analyze the "late postoperative complication rate (>30 days)" for these 2 procedures. Randomized controlled trials (RCTs) published between 2000 and 2015 comparing the late complication rates, that is, >30 days following LVSG and LRYGB in adult population (ie, 16 y and above) were selected from PubMed, Medline, Embase, Science Citation Index, Current Contents, and the Cochrane database. The outcome variables analyzed included mortality rate, major and minor complications, and interventions required for their management and readmission rates. Random effects model was used to calculate the effect size of both binary and continuous data. Heterogeneity among the outcome variables of these trials was determined by the Cochran Q statistic and I index. The meta-analysis was prepared in accordance with the Preferred Reporting of Systematic Reviews and Meta-Analyses guidelines. Six RCTs involving a total of 685 patients (LVSG, n=345; LRYGB, n=340) reported late major complications. A nonstatistical reduction in relative odds favoring the LVSG procedure was observed [odds ratio (OR), 0.64; 95% confidence interval (CI), 0.21-1.97; P=0.4]. Four RCTs representing 408 patients (LVSG, n=208; LRYGB, n=200) reported late minor complications. A nonstatistically significant reduction of 36% in relative odds favoring the LVSG procedure was observed (OR, 0.64; 95% CI, 0.28-1.47; P=0.3). A 37% relative reduction in odds was observed in favor of the LVSG for the need for additional interventions to manage late postoperative complications that did not reach statistical significance (OR, 0.63; 95% CI, 0.19-2.05; P=0.4). No study specifically reported readmissions required for the management of late complication. This meta-analysis and systematic review of RCTs shows that the development of late (major and minor) complications is similar between LVSG and LRYGB procedures, 6 months to 3 years postoperatively, and they do not lead to higher readmission rate or reoperation rate for either procedure. However longer-term surveillance is required to accurately describe the patterns of late complications in these patients.

  11. E-cigarettes and smoking cessation in real-world and clinical settings: a systematic review and meta-analysis.

    PubMed

    Kalkhoran, Sara; Glantz, Stanton A

    2016-02-01

    Smokers increasingly use e-cigarettes for many reasons, including attempts to quit combustible cigarettes and to use nicotine where smoking is prohibited. We aimed to assess the association between e-cigarette use and cigarette smoking cessation among adult cigarette smokers, irrespective of their motivation for using e-cigarettes. PubMed and Web of Science were searched between April 27, 2015, and June 17, 2015. Data extracted included study location, design, population, definition and prevalence of e-cigarette use, comparison group (if applicable), cigarette consumption, level of nicotine dependence, other confounders, definition of quitting smoking, and odds of quitting smoking. The primary endpoint was cigarette smoking cessation. Odds of smoking cessation among smokers using e-cigarettes compared with smokers not using e-cigarettes were assessed using a random effects meta-analysis. A modification of the ACROBAT-NRSI tool and the Cochrane Risk of Bias Tool were used to assess bias. This meta-analysis is registered with PROSPERO (number CRD42015020382). 38 studies (of 577 studies identified) were included in the systematic review; all 20 studies with control groups (15 cohort studies, three cross-sectional studies, and two clinical trials) were included in random effects meta-analysis and sensitivity analyses. Odds of quitting cigarettes were 28% lower in those who used e-cigarettes compared with those who did not use e-cigarettes (odds ratio [OR] 0·72, 95% CI 0·57-0·91). Association of e-cigarette use with quitting did not significantly differ among studies of all smokers using e-cigarettes (irrespective of interest in quitting cigarettes) compared with studies of only smokers interested in cigarette cessation (OR 0·63, 95% CI 0·45-0·86 vs 0·86, 0·60-1·23; p=0·94). Other study characteristics (design, population, comparison group, control variables, time of exposure assessment, biochemical verification of abstinence, and definition of e-cigarette use) were also not associated with the overall effect size (p≥0·77 in all cases). As currently being used, e-cigarettes are associated with significantly less quitting among smokers. National Institutes of Health, National Cancer Institute, FDA Center for Tobacco Products. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Outcomes After Direct Thrombectomy or Combined Intravenous and Endovascular Treatment Are Not Different.

    PubMed

    Abilleira, Sònia; Ribera, Aida; Cardona, Pedro; Rubiera, Marta; López-Cancio, Elena; Amaro, Sergi; Rodríguez-Campello, Ana; Camps-Renom, Pol; Cánovas, David; de Miquel, Maria Angels; Tomasello, Alejandro; Remollo, Sebastian; López-Rueda, Antonio; Vivas, Elio; Perendreu, Joan; Gallofré, Miquel

    2017-02-01

    Whether intravenous thrombolysis adds a further benefit when given before endovascular thrombectomy (EVT) is unknown. Furthermore, intravenous thrombolysis delays time to groin puncture, mainly among drip and ship patients. Using region-wide registry data, we selected cases that received direct EVT or combined intravenous thrombolysis+EVT for anterior circulation strokes between January 2011 and October 2015. Treatment effect was estimated by stratification on a propensity score. The average odds ratios for the association of treatment with good outcome and death at 3 months and symptomatic bleedings at 24 hours were calculated with the Mantel-Haenszel test statistic. We included 599 direct EVT patients and 567 patients with combined treatment. Stratification through propensity score achieved balance of baseline characteristics across treatment groups. There was no association between treatment modality and good outcome (odds ratio, 0.97; 95% confidence interval, 0.74-1.27), death (odds ratio, 1.07; 95% confidence interval, 0.74-1.54), or symptomatic bleedings (odds ratio, 0.56; 95% confidence interval, 0.25-1.27). This observational study suggests that outcomes after direct EVT or combined intravenous thrombolysis+EVT are not different. If confirmed by a randomized controlled trial, it may have a significant impact on organization of stroke systems of care. © 2017 American Heart Association, Inc.

  13. Hemodialysis without Systemic Anticoagulation: A Prospective Randomized Trial to Evaluate 3 Strategies in Patients at Risk of Bleeding

    PubMed Central

    Guéry, Bruno; Alberti, Corinne; Servais, Aude; Harrami, Elarbi; Bererhi, Lynda; Zins, Brigitte; Touam, Malik; Joly, Dominique

    2014-01-01

    Objective In this clinical trial, we aimed to compare three means of performing chronic hemodialysis in patients with contra-indication to systemic heparinization. Methods This open-label monocentric randomized « n-of-one » trial, conducted in a single tertiary care center, recruited chronic hemodialysis patients with a contra-indication to systemic heparinization for at least 3 consecutive sessions. All patients underwent hemodialysis with an AN69ST dialyzer, and were administered three alternative dialysis procedures in a random sequence: intermittent saline flushes, constant saline infusion, or pre-dialysis heparin coating of the membrane. The primary outcome was the need to interrupt the dialysis session because of clotting events due to either (i) a complete coagulation of the circuit; (ii) a partial coagulation of the circuit; (iii) a>50% rise over baseline in the venous pressure. Results At the end of the inclusion period (May, 2007 to December, 2008), the number of patients to include (n = 75) was not reached: only 46 patients were included and underwent randomization. The study was terminated, and statistical analysis took into account 224 hemodialysis sessions performed in 44 patients with analyzable data. Heparin adsorption was associated with a significant reduction of the need to interrupt the dialysis session because of clotting events: odds ratio 0.3 (CI 95% 0.2 to 0.6; p<0.001, versus intermittent saline flushes). Heparin adsorption was also associated with higher odds for performing >3 h dialysis sessions and for having complete blood restitution. There were no significant effects of the dialysis procedure on weight loss, online ionic dialysance, and adverse events. Conclusion Heparin-coated AN69ST dialysis membrane is a safe and effective method to avoid or delay per-dialytic clotting events in patients with contra-indication to systemic anticoagulation. However, results are not generalizable safely to patients with active bleeding, since weak heparinemia, not assessed in this study, may occur. Trial Registration ClinicalTrials.gov NCT00473109. PMID:24825343

  14. Endovascular Therapy Is Effective and Safe for Patients With Severe Ischemic Stroke: Pooled Analysis of Interventional Management of Stroke III and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands Data.

    PubMed

    Broderick, Joseph P; Berkhemer, Olvert A; Palesch, Yuko Y; Dippel, Diederik W J; Foster, Lydia D; Roos, Yvo B W E M; van der Lugt, Aad; Tomsick, Thomas A; Majoie, Charles B L M; van Zwam, Wim H; Demchuk, Andrew M; van Oostenbrugge, Robert J; Khatri, Pooja; Lingsma, Hester F; Hill, Michael D; Roozenbeek, Bob; Jauch, Edward C; Jovin, Tudor G; Yan, Bernard; von Kummer, Rüdiger; Molina, Carlos A; Goyal, Mayank; Schonewille, Wouter J; Mazighi, Mikael; Engelter, Stefan T; Anderson, Craig S; Spilker, Judith; Carrozzella, Janice; Ryckborst, Karla J; Janis, L Scott; Simpson, Kit N

    2015-12-01

    We assessed the effect of endovascular treatment in acute ischemic stroke patients with severe neurological deficit (National Institutes of Health Stroke Scale score, ≥20) after a prespecified analysis plan. The pooled analysis of the Interventional Management of Stroke III (IMS III) and Multicenter Randomized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trials included participants with an National Institutes of Health Stroke Scale score of ≥20 before intravenous tissue-type plasminogen activator (tPA) treatment (IMS III) or randomization (MR CLEAN) who were treated with intravenous tPA ≤3 hours of stroke onset. Our hypothesis was that participants with severe stroke randomized to endovascular therapy after intravenous tPA would have improved 90-day outcome (distribution of modified Rankin Scale scores), when compared with those who received intravenous tPA alone. Among 342 participants in the pooled analysis (194 from IMS III and 148 from MR CLEAN), an ordinal logistic regression model showed that the endovascular group had superior 90-day outcome compared with the intravenous tPA group (adjusted odds ratio, 1.78; 95% confidence interval, 1.20-2.66). In the logistic regression model of the dichotomous outcome (modified Rankin Scale score, 0-2, or functional independence), the endovascular group had superior outcomes (adjusted odds ratio, 1.97; 95% confidence interval, 1.09-3.56). Functional independence (modified Rankin Scale score, ≤2) at 90 days was 25% in the endovascular group when compared with 14% in the intravenous tPA group. Endovascular therapy after intravenous tPA within 3 hours of symptom onset improves functional outcome at 90 days after severe ischemic stroke. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424 (IMS III) and ISRCTN10888758 (MR CLEAN). © 2015 American Heart Association, Inc.

  15. Meta-analysis of pre-operative magnetic resonance imaging (MRI) and surgical treatment for breast cancer.

    PubMed

    Houssami, Nehmat; Turner, Robin M; Morrow, Monica

    2017-09-01

    Although there is no consensus on whether pre-operative MRI in women with breast cancer (BC) benefits surgical treatment, MRI continues to be used pre-operatively in practice. This meta-analysis examines the association between pre-operative MRI and surgical outcomes in BC. A systematic review was performed to identify studies reporting quantitative data on pre-operative MRI and surgical outcomes (without restriction by type of surgery received or type of BC) and using a controlled design. Random-effects logistic regression calculated the pooled odds ratio (OR) for each surgical outcome (MRI vs. no-MRI groups), and estimated ORs stratified by study-level age. Subgroup analysis was performed for invasive lobular cancer (ILC). Nineteen studies met eligibility criteria: 3 RCTs and 16 comparative studies that included newly diagnosed BC of any type except for three studies restricted to ILC. Primary analysis (85,975 subjects) showed that pre-operative MRI was associated with increased odds of receiving mastectomy [OR 1.39 (1.23, 1.57); p < 0.001]; similar findings were shown in analyses stratified by study-level median age. Secondary analyses did not find statistical evidence of an effect of MRI on the rates of re-excision, re-operation, or positive margins; however, MRI was significantly associated with increased odds of receiving contralateral prophylactic mastectomy [OR 1.91 (1.25, 2.91); p = 0.003]. Subgroup analysis for ILC did not find any association between MRI and the odds of receiving mastectomy [OR 1.00 (0.75, 1.33); p = 0.988] or the odds of re-excision [OR 0.65 (0.35, 1.24); p = 0.192]. Pre-operative MRI is associated with increased odds of receiving ipsilateral mastectomy and contralateral prophylactic mastectomy as surgical treatment in newly diagnosed BC patients.

  16. Measures of clustering and heterogeneity in multilevel Poisson regression analyses of rates/count data

    PubMed Central

    Austin, Peter C.; Stryhn, Henrik; Leckie, George; Merlo, Juan

    2017-01-01

    Multilevel data occur frequently in many research areas like health services research and epidemiology. A suitable way to analyze such data is through the use of multilevel regression models. These models incorporate cluster‐specific random effects that allow one to partition the total variation in the outcome into between‐cluster variation and between‐individual variation. The magnitude of the effect of clustering provides a measure of the general contextual effect. When outcomes are binary or time‐to‐event in nature, the general contextual effect can be quantified by measures of heterogeneity like the median odds ratio or the median hazard ratio, respectively, which can be calculated from a multilevel regression model. Outcomes that are integer counts denoting the number of times that an event occurred are common in epidemiological and medical research. The median (incidence) rate ratio in multilevel Poisson regression for counts that corresponds to the median odds ratio or median hazard ratio for binary or time‐to‐event outcomes respectively is relatively unknown and is rarely used. The median rate ratio is the median relative change in the rate of the occurrence of the event when comparing identical subjects from 2 randomly selected different clusters that are ordered by rate. We also describe how the variance partition coefficient, which denotes the proportion of the variation in the outcome that is attributable to between‐cluster differences, can be computed with count outcomes. We illustrate the application and interpretation of these measures in a case study analyzing the rate of hospital readmission in patients discharged from hospital with a diagnosis of heart failure. PMID:29114926

  17. The impact of a healthy media use intervention on sleep in preschool children.

    PubMed

    Garrison, Michelle M; Christakis, Dimitri A

    2012-09-01

    Although observational studies have consistently reported an association between media use and child sleep problems, it is unclear whether the relationship is causal or if an intervention targeting healthy media use can improve sleep in preschool-aged children. We conducted a randomized controlled trial of a healthy media use intervention in families of children aged 3 to 5 years. The intervention encouraged families to replace violent or age-inappropriate media content with quality educational and prosocial content, through an initial home visit and follow-up telephone calls over 6 months. Sleep measures were derived from the Child Sleep Habits Questionnaire and were collected at 6, 12, and 18 months after baseline; repeated-measures regression analyses were used. Among the 565 children analyzed, the most common sleep problem was delayed sleep-onset latency (38%). Children in the intervention group had significantly lower odds of "any sleep problem" at follow-up in the repeated-measures analysis (odds ratio = 0.36; 95% confidence interval: 0.16 to 0.83), with a trend toward a decrease in intervention effect over time (P = .07). Although there was no significant effect modification detected by baseline sleep or behavior problems, gender, or low-income status, there was a trend (P = .096) toward an increased effect among those with high levels of violence exposure at baseline. The significant effects of a healthy media use intervention on child sleep problems in the context of a randomized controlled trial suggest that the previously reported relationship between media use and child sleep problems is indeed causal in nature.

  18. Endoscopic versus Percutaneous Biliary Drainage in Palliation of Advanced Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review

    PubMed Central

    Dharmapuri, Sirish; Duvvuri, Abhiram; Dharmapuri, Sowmya; Boddireddy, Raghuveer; Moole, Vishnu; Yedama, Prathyusha; Bondalapati, Naveen; Uppu, Achuta

    2016-01-01

    Background. Palliation in advanced unresectable hilar malignancies can be achieved by endoscopic (EBD) or percutaneous transhepatic biliary drainage (PTBD). It is unclear if one approach is superior to the other in this group of patients. Aims. Compare clinical outcomes of EBD versus PTBD. Methods. (i) Study Selection Criterion. Studies using PTBD and EBD for palliation of advanced unresectable hilar malignancies. (ii) Data Collection and Extraction. Articles were searched in Medline, PubMed, and Ovid journals. (iii) Statistical Method. Fixed and random effects models were used to calculate the pooled proportions. Results. Initial search identified 786 reference articles, in which 62 articles were selected and reviewed. Data was extracted from nine studies (N = 546) that met the inclusion criterion. The pooled odds ratio for successful biliary drainage in PTBD versus EBD was 2.53 (95% CI = 1.57 to 4.08). Odds ratio for overall adverse effects in PTBD versus EBD groups was 0.81 (95% CI = 0.52 to 1.26). Odds ratio for 30-day mortality rate in PTBD group versus EBD group was 0.84 (95% CI = 0.37 to 1.91). Conclusions. In patients with advanced unresectable hilar malignancies, palliation with PTBD seems to be superior to EBD. PTBD is comparable to EBD in regard to overall adverse effects and 30-day mortality. PMID:27648439

  19. Assessing the Role of Context on the Relationship Between Adolescent Marijuana Use and Property Crimes in Mexico.

    PubMed

    Vilalta, Carlos Javier; Allmang, Skye

    2017-01-28

    A limited amount of research has been conducted on the association between marijuana use and adolescent crime in developing countries such as Mexico, where crime rates are high and marijuana use is increasing. To examine the association between the frequency of marijuana use and the likelihood of committing of a property crime, and to identify contextual factors explaining individual differences in the likelihood of committing a property crime. The contribution of marijuana use to property crimes was examined based on two nationwide probabilistic surveys of public high school students, using a multilevel mixed effects logistic regression model. Marijuana use significantly increased the odds of committing a property crime. Differences between schools were observed in the random effects of marijuana use, suggesting that the likelihood of committing a property crime was differentially affected by contextual factors. In addition, students who were victims of bullying by peers and who had parents that abused alcohol had higher odds of committing a property crime. Perceived disorder in students' schools and neighborhoods also increased students' odds of reporting that they had committed a property crime. The importance of the effect of school context on the relationship between marijuana use and the commission of a property crime among Mexican public high school students seemed to increase over time. However, these results may also be due to changes in sampling designs over time.

  20. Secretaries, depression and absenteeism.

    PubMed

    Garrison, R; Eaton, W W

    1992-01-01

    This study examines the prevalence of Major Depressive Disorder; missed work; and mental health services use among secretaries and other women employed full-time. In a random sample of 3,484 women employed full-time, women employed as secretaries were significantly more likely to be depressed than other women even after controlling for socio-demographic characteristics (odds ratio = 1.69, 95% confidence interval = 1.05, 2.73). Secretaries were significantly more likely to report missing work in the last three months (odds ratio = 1.77, confidence interval = 1.01, 3.11); a finding not attributable to depression. Secretaries were also more likely to seek mental health services, but this finding was not significant (odds ratio = 1.78, confidence interval = 0.55, 5.78). It is possible that these findings are attributable to a selection effect whereby depressed women, and women who are likely to miss work, become secretaries. A second possibility is that women employed as secretaries have more "nonwork role stress" than other employed women. Alternatively, job conditions which result in dissatisfaction and stress may lead to depression and absenteeism. We believe our findings warrant further investigation into the work environment of secretaries.

  1. Arterial Obstruction on Computed Tomographic or Magnetic Resonance Angiography and Response to Intravenous Thrombolytics in Ischemic Stroke

    PubMed Central

    Mair, Grant; von Kummer, Rüdiger; Adami, Alessandro; White, Philip M.; Adams, Matthew E.; Yan, Bernard; Demchuk, Andrew M.; Farrall, Andrew J.; Sellar, Robin J.; Sakka, Eleni; Palmer, Jeb; Perry, David; Lindley, Richard I.; Sandercock, Peter A.G.

    2017-01-01

    Background and Purpose— Computed tomographic angiography and magnetic resonance angiography are used increasingly to assess arterial patency in patients with ischemic stroke. We determined which baseline angiography features predict response to intravenous thrombolytics in ischemic stroke using randomized controlled trial data. Methods— We analyzed angiograms from the IST-3 (Third International Stroke Trial), an international, multicenter, prospective, randomized controlled trial of intravenous alteplase. Readers, masked to clinical, treatment, and outcome data, assessed prerandomization computed tomographic angiography and magnetic resonance angiography for presence, extent, location, and completeness of obstruction and collaterals. We compared angiography findings to 6-month functional outcome (Oxford Handicap Scale) and tested for interactions with alteplase, using ordinal regression in adjusted analyses. We also meta-analyzed all available angiography data from other randomized controlled trials of intravenous thrombolytics. Results— In IST-3, 300 patients had prerandomization angiography (computed tomographic angiography=271 and magnetic resonance angiography=29). On multivariable analysis, more extensive angiographic obstruction and poor collaterals independently predicted poor outcome (P<0.01). We identified no significant interaction between angiography findings and alteplase effect on Oxford Handicap Scale (P≥0.075) in IST-3. In meta-analysis (5 trials of alteplase or desmoteplase, including IST-3, n=591), there was a significantly increased benefit of thrombolytics on outcome (odds ratio>1 indicates benefit) in patients with (odds ratio, 2.07; 95% confidence interval, 1.18–3.64; P=0.011) versus without (odds ratio, 0.88; 95% confidence interval, 0.58–1.35; P=0.566) arterial obstruction (P for interaction 0.017). Conclusions— Intravenous thrombolytics provide benefit to stroke patients with computed tomographic angiography or magnetic resonance angiography evidence of arterial obstruction, but the sample was underpowered to demonstrate significant treatment benefit or harm among patients with apparently patent arteries. Clinical Trial Registration— URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518. PMID:28008093

  2. Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

    PubMed

    Ogedegbe, Gbenga; Tobin, Jonathan N; Fernandez, Senaida; Cassells, Andrea; Diaz-Gloster, Marleny; Khalida, Chamanara; Pickering, Thomas; Schwartz, Joseph E

    2014-05-20

    Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. http://www.clinicaltrials.gov. Unique identifier: NCT00233220. © 2014 American Heart Association, Inc.

  3. Arterial Obstruction on Computed Tomographic or Magnetic Resonance Angiography and Response to Intravenous Thrombolytics in Ischemic Stroke.

    PubMed

    Mair, Grant; von Kummer, Rüdiger; Adami, Alessandro; White, Philip M; Adams, Matthew E; Yan, Bernard; Demchuk, Andrew M; Farrall, Andrew J; Sellar, Robin J; Sakka, Eleni; Palmer, Jeb; Perry, David; Lindley, Richard I; Sandercock, Peter A G; Wardlaw, Joanna M

    2017-02-01

    Computed tomographic angiography and magnetic resonance angiography are used increasingly to assess arterial patency in patients with ischemic stroke. We determined which baseline angiography features predict response to intravenous thrombolytics in ischemic stroke using randomized controlled trial data. We analyzed angiograms from the IST-3 (Third International Stroke Trial), an international, multicenter, prospective, randomized controlled trial of intravenous alteplase. Readers, masked to clinical, treatment, and outcome data, assessed prerandomization computed tomographic angiography and magnetic resonance angiography for presence, extent, location, and completeness of obstruction and collaterals. We compared angiography findings to 6-month functional outcome (Oxford Handicap Scale) and tested for interactions with alteplase, using ordinal regression in adjusted analyses. We also meta-analyzed all available angiography data from other randomized controlled trials of intravenous thrombolytics. In IST-3, 300 patients had prerandomization angiography (computed tomographic angiography=271 and magnetic resonance angiography=29). On multivariable analysis, more extensive angiographic obstruction and poor collaterals independently predicted poor outcome (P<0.01). We identified no significant interaction between angiography findings and alteplase effect on Oxford Handicap Scale (P≥0.075) in IST-3. In meta-analysis (5 trials of alteplase or desmoteplase, including IST-3, n=591), there was a significantly increased benefit of thrombolytics on outcome (odds ratio>1 indicates benefit) in patients with (odds ratio, 2.07; 95% confidence interval, 1.18-3.64; P=0.011) versus without (odds ratio, 0.88; 95% confidence interval, 0.58-1.35; P=0.566) arterial obstruction (P for interaction 0.017). Intravenous thrombolytics provide benefit to stroke patients with computed tomographic angiography or magnetic resonance angiography evidence of arterial obstruction, but the sample was underpowered to demonstrate significant treatment benefit or harm among patients with apparently patent arteries. URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518. © 2016 The Authors.

  4. Meta-analysis of laparoscopic versus open repair of perforated peptic ulcer.

    PubMed

    Antoniou, Stavros A; Antoniou, George A; Koch, Oliver O; Pointner, Rudolph; Granderath, Frank A

    2013-01-01

    Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU.

  5. Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer

    PubMed Central

    Antoniou, George A.; Koch, Oliver O.; Pointner, Rudolph; Granderath, Frank A.

    2013-01-01

    Background and Objectives: Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. Methods: We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Results: Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. Conclusion: In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU. PMID:23743368

  6. School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial.

    PubMed

    Szilagyi, Peter G; Schaffer, Stanley; Rand, Cynthia M; Goldstein, Nicolas P N; Vincelli, Phyllis; Hightower, A Dirk; Younge, Mary; Eagan, Ashley; Blumkin, Aaron; Albertin, Christina S; DiBitetto, Kristine; Yoo, Byung-Kwang; Humiston, Sharon G

    2018-02-01

    We aimed to evaluate the effect of school-located influenza vaccination (SLIV) on adolescents' influenza vaccination rates. In 2015-2016, we performed a cluster-randomized trial of adolescent SLIV in middle/high schools. We selected 10 pairs of schools (identical grades within pairs) and randomly allocated schools within pairs to SLIV or usual care control. At eight suburban SLIV schools, we sent parents e-mail notifications about upcoming SLIV clinics and promoted online immunization consent. At two urban SLIV schools, we sent parents (via student backpack fliers) paper immunization consent forms and information about SLIV. E-mails were unavailable at these schools. Local health department nurses administered nasal or injectable influenza vaccine at dedicated SLIV clinics and billed insurers. We compared influenza vaccination rates at SLIV versus control schools using school directories to identify the student sample in each school. We used the state immunization registry to determine receipt of influenza vaccination. The final sample comprised 17,650 students enrolled in the 20 schools. Adolescents at suburban SLIV schools had higher overall influenza vaccination rates than did adolescents at control schools (51% vs. 46%, p < .001; adjusted odds ratio = 1.27, 95% confidence interval 1.18-1.38, controlling for vaccination during the prior two seasons). No effect of SLIV was noted among urbanschools on multivariate analysis. SLIV did not substitute for vaccinations in primary care or other settings; in suburban settings, SLIV was associated with increased vaccinations in primary care or other settings (adjusted odds ratio = 1.10, 95% confidence interval 1.02-1.19). SLIV in this community increased influenza vaccination rates among adolescents attending suburban schools. Copyright © 2018. Published by Elsevier Inc.

  7. Effect of a Combination of Intranasal Ketorolac and Nitrous Oxide on the Success of the Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Study.

    PubMed

    Stentz, Daniel; Drum, Melissa; Reader, Al; Nusstein, John; Fowler, Sara; Beck, Mike

    2018-01-01

    Previous studies in patients with irreversible pulpitis have reported increased success of the inferior alveolar nerve block (IANB) using premedication with ketorolac. Preemptive nitrous oxide administration has also shown an increase in the success of the IANB. Recently, ketorolac has been made available for intranasal delivery. Perhaps combining ketorolac and nitrous oxide would increase success. Therefore, the purpose of this prospective, randomized, double-blind study was to determine the effect of a combination of intranasal ketorolac and nitrous oxide/oxygen on the anesthetic success of the IANB in patients presenting with symptomatic irreversible pulpitis. One hundred two patients experiencing spontaneous moderate to severe pain with symptomatic irreversible pulpitis in a mandibular posterior tooth participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac or intranasal saline placebo 20 minutes before the administration of nitrous oxide/oxygen. Ten minutes after the administration of nitrous oxide/oxygen, the IANB was given. After profound lip numbness, endodontic treatment was performed. Success was defined as the ability to perform endodontic access and instrumentation with no pain or mild pain. The odds of success for the IANB was 1.631 in the intranasal saline/nitrous oxide group versus the intranasal ketorolac/nitrous oxide group with no significant difference between the groups (P = .2523). Premedication with intranasal ketorolac did not significantly increase the odds of success for the IANB over the use of nitrous oxide/oxygen alone. Supplemental anesthesia will still be needed to achieve adequate anesthesia. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. Comparison of WBRT alone, SRS alone, and their combination in the treatment of one or more brain metastases: Review and meta-analysis.

    PubMed

    Khan, Muhammad; Lin, Jie; Liao, Guixiang; Li, Rong; Wang, Baiyao; Xie, Guozhu; Zheng, Jieling; Yuan, Yawei

    2017-07-01

    Whole brain radiotherapy has been a standard treatment of brain metastases. Stereotactic radiosurgery provides more focal and aggressive radiation and normal tissue sparing but worse local and distant control. This meta-analysis was performed to assess and compare the effectiveness of whole brain radiotherapy alone, stereotactic radiosurgery alone, and their combination in the treatment of brain metastases based on randomized controlled trial studies. Electronic databases (PubMed, MEDLINE, Embase, and Cochrane Library) were searched to identify randomized controlled trial studies that compared treatment outcome of whole brain radiotherapy and stereotactic radiosurgery. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were hazard ratios with 95% confidence intervals calculated for time-to-event data extracted from survival curves and local tumor control rate curves. Odds ratio with 95% confidence intervals were calculated for dichotomous data, while mean differences with 95% confidence intervals were calculated for continuous data. Fixed-effects or random-effects models were adopted according to heterogeneity. Five studies (n = 763) were included in this meta-analysis meeting the inclusion criteria. All the included studies were randomized controlled trials. The sample size ranged from 27 to 331. In total 202 (26%) patients with whole brain radiotherapy alone, 196 (26%) patients receiving stereotactic radiosurgery alone, and 365 (48%) patients were in whole brain radiotherapy plus stereotactic radiosurgery group. No significant survival benefit was observed for any treatment approach; hazard ratio was 1.19 (95% confidence interval: 0.96-1.43, p = 0.12) based on three randomized controlled trials for whole brain radiotherapy only compared to whole brain radiotherapy plus stereotactic radiosurgery and hazard ratio was 1.03 (95% confidence interval: 0.82-1.29, p = 0.81) for stereotactic radiosurgery only compared to combined approach. Local control was best achieved when whole brain radiotherapy was combined with stereotactic radiosurgery. Hazard ratio 2.05 (95% confidence interval: 1.36-3.09, p = 0.0006) and hazard ratio 1.84 (95% confidence interval: 1.26-2.70, p = 0.002) were obtained from comparing whole brain radiotherapy only and stereotactic radiosurgery only to whole brain radiotherapy + stereotactic radiosurgery, respectively. No difference in adverse events for treatment difference; odds ratio 1.16 (95% confidence interval: 0.77-1.76, p = 0.48) and odds ratio 0.92 (95% confidence interval: 0.59-1.42, p = 71) for whole brain radiotherapy + stereotactic radiosurgery versus whole brain radiotherapy only and whole brain radiotherapy + stereotactic radiosurgery versus stereotactic radiosurgery only, respectively. Adding stereotactic radiosurgery to whole brain radiotherapy provides better local control as compared to whole brain radiotherapy only and stereotactic radiosurgery only with no difference in radiation related toxicities.

  9. Effectiveness of an HIV/STD risk-reduction intervention for adolescents when implemented by community-based organizations: a cluster-randomized controlled trial.

    PubMed

    Jemmott, John B; Jemmott, Loretta S; Fong, Geoffrey T; Morales, Knashawn H

    2010-04-01

    We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (beta = 0.06; 95% CI = 0.00, 0.12) than did the control group. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established.

  10. Effectiveness of an HIV/STD Risk-Reduction Intervention for Adolescents When Implemented by Community-Based Organizations: A Cluster-Randomized Controlled Trial

    PubMed Central

    Jemmott, Loretta S.; Fong, Geoffrey T.; Morales, Knashawn H.

    2010-01-01

    Objectives. We evaluated the effectiveness of an HIV/STD risk-reduction intervention when implemented by community-based organizations (CBOs). Methods. In a cluster-randomized controlled trial, 86 CBOs that served African American adolescents aged 13 to 18 years were randomized to implement either an HIV/STD risk-reduction intervention whose efficacy has been demonstrated or a health-promotion control intervention. CBOs agreed to implement 6 intervention groups, a random half of which completed 3-, 6-, and 12-month follow-up assessments. The primary outcome was consistent condom use in the 3 months prior to each follow-up assessment, averaged over the follow-up assessments. Results. Participants were 1707 adolescents, 863 in HIV/STD-intervention CBOs and 844 in control-intervention CBOs. HIV/STD-intervention participants were more likely to report consistent condom use (odds ratio [OR] = 1.39; 95% confidence interval [CI] = 1.06, 1.84) than were control-intervention participants. HIV/STD-intervention participants also reported a greater proportion of condom-protected intercourse (β = 0.06; 95% CI = 0.00, 0.12) than did the control group. Conclusions. This is the first large, randomized intervention trial to demonstrate that CBOs can successfully implement an HIV/STD risk-reduction intervention whose efficacy has been established. PMID:20167903

  11. The buffering effect of tangible social support on financial stress: influence on psychological well-being and psychosomatic symptoms in a large sample of the adult general population.

    PubMed

    Åslund, Cecilia; Larm, Peter; Starrin, Bengt; Nilsson, Kent W

    2014-09-28

    Financial stress is an important source of distress and is related to poor mental and physical health outcomes. The present study investigated whether tangible social support could buffer the effect of financial stress on psychological and psychosomatic health. Two separate postal surveys were sent to random samples in five counties in Sweden in 2004 and 2008, with a total of 84 263 respondents. The questionnaires included questions about financial stress, tangible social support, psychosomatic symptoms, and psychological well-being (General Health Questionnaire-12). Individuals with high financial stress and low tangible social support had six to seven times increased odds ratios for low psychological well-being and many psychosomatic symptoms. By contrast, individuals with high financial stress and high tangible social support had only two to three times increased odds ratios for low psychological well-being and three to four times increased odds ratios for many psychosomatic symptoms, suggesting a buffering effect of tangible social support. Consistent with the buffering hypothesis, there were significant interactions between financial stress and social support, particularly in relation to low psychological well-being. Social support had its strongest effect at high levels of financial stress. The question whether the altering of our social networks may improve physical health is important for the prevention of ill health in people experiencing financial stress. Strengthening social networks may have the potential to influence health-care costs and improve quality of life.

  12. Influence of gender role attitudes on smoking and drinking among girls from Jujuy, Argentina.

    PubMed

    Mejia, Raul; Kaplan, Celia P; Alderete, Ethel; Gregorich, Steven E; Pérez-Stable, Eliseo J

    2013-09-01

    Evaluate effect of gender role attitudes on tobacco and alcohol use among Argentinean girls. Cross-sectional survey of 10th grade students attending 27 randomly selected schools in Jujuy, Argentina. Questions about tobacco and alcohol use were adapted from global youth surveys. Five items with 5-point response options of agreement-disagreement assessed attitude towards egalitarian (higher score) gender roles. 2133 girls, aged 13-18 years, 71% Indigenous, 22% mixed Indigenous/European, and 7% European responded. Of these, 60% had ever smoked, 32% were current smokers, 58% ever drinkers, 27% drank in previous month, and 13% had ≥5 drinks on one occasion. Mean response to the gender role scale was 3.49 (95% Confidence Intervals = 3.41-3.57) out of 5 tending toward egalitarian attitudes. Logistic regression models using the gender role scale score as the main predictor and adjusting for demographic and social confounders showed that egalitarian gender role was associated with ever smoking (Odds Ratio = 1.25; 95% Confidence Intervals 1.09-1.44), ever drinking (Odds Ratio = 1.24; 95% Confidence Intervals 1.10-1.40), drinking in prior month (Odds Ratio = 1.21; 95% Confidence Intervals 1.07-1.37) and ≥5 drinks on one occasion (Odds Ratio = 1.15; 95% Confidence Intervals 1.00-1.33), but was not significant for current smoking. Girls in Jujuy who reported more egalitarian gender role attitudes had higher odds of smoking or drinking. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Covered versus uncovered self-expandable metal stents for malignant biliary strictures: A meta-analysis and systematic review.

    PubMed

    Moole, Harsha; Bechtold, Matthew L; Cashman, Micheal; Volmar, Fritz H; Dhillon, Sonu; Forcione, David; Taneja, Deepak; Puli, Srinivas R

    2016-09-01

    Self-expandable metal stents (SEMS) are used for palliating inoperable malignant biliary strictures. It is unclear if covered metal stents are superior to uncovered metal stents in these patients. We compared clinical outcomes in patients with covered and uncovered stents. Studies using covered and uncovered metallic stents for palliation in patients with malignant biliary stricture were reviewed. Articles were searched in MEDLINE, PubMed, and Ovid journals. Fixed and random effects models were used to calculate the pooled proportions. Initial search identified 1436 reference articles, of which 132 were selected and reviewed. Thirteen studies (n = 2239) for covered and uncovered metallic stents which met the inclusion criteria were included in this analysis. Odds ratio for stent occlusion rates in covered vs. uncovered stents was 0.79 (95 % CI = 0.65 to 0.96). Survival benefit in patients with covered vs. uncovered stents showed the odds ratio to be 1.29 (95 % CI = 0.95 to 1.74). Pooled odds ratio for migration of covered vs. uncovered stents was 9.9 (95 % CI = 4.5 to 22.3). Covered stents seemed to have significantly lesser occlusion rates, increased odds of migration, and increased odds of pancreatitis compared to uncovered stents. There was no statistically significant difference in the survival benefit, overall adverse event rate, and patency period of covered vs. uncovered metal stents in patients with malignant biliary strictures.

  14. Diffusion of Bevacizumab Across Oncology Practices: An Observational Study.

    PubMed

    Keating, Nancy L; Huskamp, Haiden A; Schrag, Deborah; McWilliams, John M; McNeil, Barbara J; Landon, Bruce E; Chernew, Michael E; Normand, Sharon-Lise T

    2018-01-01

    Technological advances can improve care and outcomes but are a primary driver of health care spending growth. Understanding diffusion and use of new oncology therapies is important, given substantial increases in prices and spending on such treatments. Examine diffusion of bevacizumab, a novel (in 2004) and high-priced biologic cancer therapy, among US oncology practices during 2005-2012 and assess variation in use across practices. Population-based observational study. A total of 2329 US practices providing cancer chemotherapy. Random 20% sample of 236,304 Medicare fee-for-service beneficiaries aged above 65 years in 2004-2012 undergoing infused chemotherapy for cancer. Diffusion of bevacizumab (cumulative time to first use and 10% use) in practices, variation in use across practices overall and by higher versus lower-value use. We used hierarchical models with practice random effects to estimate the between-practice variation in the probability of receiving bevacizumab and to identify factors associated with use. We observed relatively rapid diffusion of bevacizumab, particularly in independent practices and larger versus smaller practices. We observed substantial variation in use; the adjusted odds ratio (95% confidence interval) of bevacizumab use was 2.90 higher (2.73-3.08) for practices 1 SD above versus one standard deviation below the mean. Variation was less for higher-value [odds ratio=2.72 (2.56-2.89)] than lower-value uses [odds ratio=3.61 (3.21-4.06)]. Use of bevacizumab varied widely across oncology practices, particularly for lower-value indications. These findings suggest that interventions targeted to practices have potential for decreasing low-value use of high-cost cancer therapies.

  15. The association of household food insecurity with the risk of type 2 diabetes mellitus in adults: a systematic review and meta-analysis.

    PubMed

    Abdurahman, Ahmed A; Chaka, Eshetu E; Nedjat, S; Dorosty, Ahmed Reza; Majdzadeh, R

    2018-05-02

    The link between household food insecurity and risk of type 2 diabetes mellitus still remains controversial. Therefore, we performed a systematic review and meta-analysis to clarify the association between household food insecurity and type 2 diabetes mellitus. EMBASE, PubMed, ISI Web of Science and Scopus databases were searched up to March 2017. The selection of studies, data extraction and assessing the risk of bias in the included studies were carried out by two reviewers independently. Study-specific odds ratios (ORs) were pooled using a random effects model. A total of 18 articles including a total of 55,353,915 adult participants were included in the meta-analysis. The pooled ORs of the cross-sectional studies revealed that household food insecurity was significantly associated with the odds of T2DM (OR 1.27, 95% CI 1.11-1.42) with no evidence of publication bias (p = 0.63) but heterogeneity between studies (I 2  = 61.1%). Similarly, subgroup analyses showed that the country where the study conducted and household food insecurity assessment tool used to influence the effect of household food insecurity on the odds of T2DM. However, the pooled ORs for two case-control and one cohort studies were not significantly associated between household food insecurity and T2DM in adults. This study strengthens the hypothesis of the household food insecurity effect on the odds of T2DM among adults. Further longitudinal studies based on larger, and more representative samples are needed to identify the underlying relationships between food insecurity and type 2 diabetes mellitus.

  16. Effect of pre-milking teat disinfection on clinical mastitis incidence in a dairy herd in Northern Queensland, Australia.

    PubMed

    Rowe, S M; Tranter, W P; Laven, R A

    2018-03-01

    To determine if a pre-milking teat disinfection protocol would reduce the incidence of clinical mastitis by greater than 50%. Two pre-milking routines were compared in a natural exposure trial. Cows from a single dairy herd were randomly assigned to control (n = 246) and experimental (pre-milking teat disinfection [PMTD]; n = 244) groups. For cows in the control group, the pre-milking routine involved minimal teat-washing, except for cows with wet teat contamination. For cows in the PMTD group, the pre-milking routine involved washing of all teats, dipping with a commercial 0.1% available iodine solution, allowing a minimum of 30 s contact time and then drying of the teats using disposable paper towel. Clinical cases encountered during the trial were recorded and pathogens were isolated from milk samples using standard laboratory methods. The effect of PMTD was determined using multivariable binary logistic regression. Multiparous animals in the PMTD group had higher odds of experiencing clinical mastitis overall and of experiencing clinical mastitis caused by environmental pathogens (odds ratio (OR) 1.97 and 4.11, 95% confidence interval (CI) 1.15-3.38 and 1.49-11.3, respectively). In primiparous animals, pre-milking teat disinfection did not reduce the odds of clinical mastitis by greater than 50% (OR 1.31, 95%CI 0.52-3.29). In this herd, PMTD increased the odds of clinical mastitis. The effectiveness of PMTD to prevent clinical mastitis in pasture-based systems is likely to vary greatly between herds. We therefore recommend against the wholesale use of this practice on Australian farms. © 2018 Australian Veterinary Association.

  17. Comparison of the effects of sternal and tibial intraosseous administered resuscitative drugs on return of spontaneous circulation in a swine model of cardiac arrest.

    PubMed

    O'Sullivan, Mara; Martinez, Andre; Long, Audrey; Johnson, Michelle; Blouin, Dawn; Johnson, Arthur D; Burgert, James M

    2016-01-01

    Compare vasopressin, amiodarone, and epinephrine administration by sternal intraosseous (SIO), tibial intraosseous (TIO), and intravenous (IV) routes in a swine model of cardiac arrest. Prospective, randomized, between subjects, experimental design. Laboratory. Male Yorkshire-cross swine (N = 35), seven per group. Swine were randomized to SIO, TIO, IV, cardiopulmonary resuscitation (CPR) with defibrillation, or CPR-only groups. Ventricular fibrillation (VF) was induced under general anesthesia. Mechanical CPR began 2 minutes postarrest. Vasopressin (40 U) was administered to the SIO, TIO, and IV groups 4 minutes postarrest. Defibrillation was performed and amiodarone (300 mg) was administered 6 minutes postarrest. Defibrillation was repeated, and epinephrine (1 mg) was administered 10 minutes postarrest. Defibrillation was repeated every 2 minutes and epinephrine repeated every 4 minutes until return of spontaneous circulation (ROSC) or 26 postarrest minutes elapsed. Rate of ROSC, time to ROSC, and odds of ROSC. There were no significant differences in rate of ROSC between the SIO and TIO (p = 0.22) or IV groups (p = 1.0). Time to ROSC was five times less in the SIO group than the TIO group (p = 0.003) but not compared to IV (p = 0.125). Time to ROSC in the IV group was significantly less than the TIO group (p = 0.04). Odds of ROSC for the SIO group were five times higher compared to the TIO group but same as IV. Odds of ROSC in the IV group were higher than the TIO group. There was a statistically significant delay in the time to ROSC and a clinically significant difference in odds of ROSC when resuscitative drugs, including lipophilic amiodarone, were administered by the TIO route compared to the SIO and IV routes in a swine model of sudden cardiac arrest. Further investigations are warranted to isolate the mechanism behind these findings.

  18. Using multilevel spatial models to understand salamander site occupancy patterns after wildfire

    USGS Publications Warehouse

    Chelgren, Nathan; Adams, Michael J.; Bailey, Larissa L.; Bury, R. Bruce

    2011-01-01

    Studies of the distribution of elusive forest wildlife have suffered from the confounding of true presence with the uncertainty of detection. Occupancy modeling, which incorporates probabilities of species detection conditional on presence, is an emerging approach for reducing observation bias. However, the current likelihood modeling framework is restrictive for handling unexplained sources of variation in the response that may occur when there are dependence structures such as smaller sampling units that are nested within larger sampling units. We used multilevel Bayesian occupancy modeling to handle dependence structures and to partition sources of variation in occupancy of sites by terrestrial salamanders (family Plethodontidae) within and surrounding an earlier wildfire in western Oregon, USA. Comparison of model fit favored a spatial N-mixture model that accounted for variation in salamander abundance over models that were based on binary detection/non-detection data. Though catch per unit effort was higher in burned areas than unburned, there was strong support that this pattern was due to a higher probability of capture for individuals in burned plots. Within the burn, the odds of capturing an individual given it was present were 2.06 times the odds outside the burn, reflecting reduced complexity of ground cover in the burn. There was weak support that true occupancy was lower within the burned area. While the odds of occupancy in the burn were 0.49 times the odds outside the burn among the five species, the magnitude of variation attributed to the burn was small in comparison to variation attributed to other landscape variables and to unexplained, spatially autocorrelated random variation. While ordinary occupancy models may separate the biological pattern of interest from variation in detection probability when all sources of variation are known, the addition of random effects structures for unexplained sources of variation in occupancy and detection probability may often more appropriately represent levels of uncertainty. ?? 2011 by the Ecological Society of America.

  19. Effectiveness of a Telehealth Service Delivery Model for Treating Attention-Deficit/Hyperactivity Disorder: A Community-Based Randomized Controlled Trial

    PubMed Central

    Myers, Kathleen; Stoep, Ann Vander; Zhou, Chuan; McCarty, Carolyn A.; Katon, Wayne

    2015-01-01

    Objective To test the effectiveness of a telehealth service delivery model for the treatment of children with attention-deficit/hyperactivity disorder (ADHD) that provided pharmacological treatment and caregiver behavior training. Method The Children’s ADHD Telemental Health Treatment Study (CATTS) was a randomized controlled trial with 223 children referred by 88 primary care providers (PCPs) in 7 communities. Children randomized to the experimental telehealth service model received 6 sessions over 22 weeks of combined pharmacotherapy, delivered by child psychiatrists through videoconferencing, and caregiver behavior training, provided in person by community therapists who were supervised remotely. Children randomized to the control service delivery model received treatment with their PCPs augmented with a telepsychiatry consultation. Outcomes were diagnostic criteria for ADHD and oppositional defiant disorder (ODD) and role performance on the Vanderbilt ADHD Rating Scale (VADRS) completed by caregivers (VADRS-Caregivers) and teachers (VADRS-Teachers) and impairment on the Columbia Impairment Scale-Parent Version (CIS-P). Measures were completed at 5 assessments over 25 weeks. Results Children in both service models improved. Children assigned to the telehealth service model improved significantly more than children in the augmented primary care arm for VADRS-Caregiver criteria for inattention (χ2[4]=19.47, p<.001), hyperactivity (χ2[4]=11.91, p=0.02), combined ADHD (χ2[4]=14.90, p=0.005), ODD (χ2[4]=10.05, p=0.04), and VADRS-Caregiver role performance (χ2 [4]=12.40, p=0.01) and CIS-P impairment (χ2[4]=20.52, p<.001). For the VADRS-Teacher diagnostic criteria, children in the telehealth service model had significantly more improvement in hyperactivity (χ2[4]=11.28, p=0.02) and combined ADHD (χ2[4]=9.72, p=0.045). Conclusion The CATTS trial demonstrated the effectiveness of a telehealth service model to treat ADHD in communities with limited access to specialty mental health services. Clinical trial registration information Children’s Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study; http://clinicaltrials.gov; NCT00830700. PMID:25791143

  20. Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial.

    PubMed

    Oberai, Praveen; Varanasi, Roja; Padmanabhan, Maya; Upadhyaya, Alok; Singh, Supriya; Singh, Samarendra Pratap; Vikram, Deepika; Khan, Tariq; Prasad, Ramesh; Gupta, A K; Singh, J R; Manchanda, Raj K

    2018-06-05

     Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program.  This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy ( n  = 325) or placebo as control ( n  = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat.  A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna ( n  = 116), Stramonium ( n  = 33), Arsenicum album ( n  = 25), Sulfur ( n  = 18), Opium ( n  = 17), and Nux vomica ( n  = 10).  Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated. The Faculty of Homeopathy.

  1. Odd versus even: a scientific study of the ‘rules’ of plating

    PubMed Central

    Michel, Charles; Spence, Charles

    2016-01-01

    We report on the results of a series of large-scale computer-based preference tests (conducted at The Science Museum in London and online) that evaluated the widely-held belief that food should be plated in odd rather than even numbers of elements in order to maximize the visual appeal of a dish. Participants were presented with pairs of plates of food showing odd versus even number of seared scallops (3 vs. 4; 1–6 in Experiment 7), arranged in a line, as a polygon or randomly, on either a round or square white plate. No consistent evidence for a preference for odd or even numbers of food items was found, thus questioning the oft-made assertion that odd number of items on a plate looks better than an even number. The implications of these results are discussed. PMID:26839741

  2. Recommending Oral Probiotics to Reduce Winter Antibiotic Prescriptions in People With Asthma: A Pragmatic Randomized Controlled Trial.

    PubMed

    Smith, Timothy D H; Watt, Hilary; Gunn, Laura; Car, Josip; Boyle, Robert J

    2016-09-01

    Evidence from studies mainly in children has shown that orally administered probiotics may prevent respiratory tract infections and associated antibiotic use. We evaluated whether advice to take daily probiotics can reduce antibiotic prescribing for winter respiratory tract infections in people with asthma. We conducted a randomized controlled, parallel-group pragmatic study for participants aged 5 years and older with asthma in a UK primary care setting. The intervention was a postal leaflet with advice to take daily probiotics from October 2013 to March 2014, compared with a standard winter advice leaflet. Primary outcome was the proportion of participants prescribed antibiotics for respiratory tract infections. There were 1,302 participants randomly assigned to a control group (n = 650) or intervention group (n = 652). There was no significant difference in the primary outcome measure, with 27.7% receiving antibiotics in the intervention group and 26.9% receiving antibiotics in the control group (odds ratio = 1.04; 95% CI, 0.82-1.34). Uptake of probiotics was low, but outcomes were similar in those who accessed probiotics (adjusted odds ratio = 1.08; 95% CI, 0.69-1.69, compared with controls). We also found no evidence of an effect on respiratory tract infections or asthma exacerbations. In this pragmatic community-based trial in people with asthma, we found no evidence that advising use of winter probiotics reduces antibiotic prescribing. © 2016 Annals of Family Medicine, Inc.

  3. Community vs. Clinic-Based Modular Treatment of Children with Early-Onset ODD or CD: A Clinical Trial with 3-Year Follow-Up

    ERIC Educational Resources Information Center

    Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar G.; Pardini, Dustin; Holden, Elizabeth A.; Hart, Jonathan

    2009-01-01

    This study examines the treatment outcomes of 139, 6-11 year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) who were randomly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community (COMM) or a clinic office (CLINIC).…

  4. Value of Computed Tomographic Perfusion-Based Patient Selection for Intra-Arterial Acute Ischemic Stroke Treatment.

    PubMed

    Borst, Jordi; Berkhemer, Olvert A; Roos, Yvo B W E M; van Bavel, Ed; van Zwam, Wim H; van Oostenbrugge, Robert J; van Walderveen, Marianne A A; Lingsma, Hester F; van der Lugt, Aad; Dippel, Diederik W J; Yoo, Albert J; Marquering, Henk A; Majoie, Charles B L M

    2015-12-01

    The utility of computed tomographic perfusion (CTP)-based patient selection for intra-arterial treatment of acute ischemic stroke has not been proven in randomized trials and requires further study in a cohort that was not selected based on CTP. Our objective was to study the relationship between CTP-derived parameters and outcome and treatment effect in patients with acute ischemic stroke because of a proximal intracranial arterial occlusion. We included 175 patients who underwent CTP in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN). Association of CTP-derived parameters (ischemic-core volume, penumbra volume, and percentage ischemic core) with outcome was estimated with multivariable ordinal logistic regression as an adjusted odds ratio for a shift in the direction of a better outcome on the modified Rankin Scale. Interaction between CTP-derived parameters and treatment effect was determined using multivariable ordinal logistic regression. Interaction with treatment effect was also tested for mismatch (core <70 mL; penumbra core >1.2; penumbra core >10 mL). The adjusted odds ratio for improved functional outcome for ischemic core, percentage ischemic core, and penumbra were 0.79 per 10 mL (95% confidence interval: 0.71-0.89; P<0.001), 0.82 per 10% (95% confidence interval: 0.66-0.90; P=0.002), and 0.97 per 10 mL (96% confidence interval: 0.92-1.01; P=0.15), respectively. No significant interaction between any of the CTP-derived parameters and treatment effect was observed. We observed no significant interaction between mismatch and treatment effect. CTP seems useful for predicting functional outcome, but cannot reliably identify patients who will not benefit from intra-arterial therapy. © 2015 American Heart Association, Inc.

  5. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

    PubMed Central

    Park, Min Hae; Shakur, Haleema; Free, Caroline

    2011-01-01

    Abstract Objective To compare medical abortion practised at home and in clinics in terms of effectiveness, safety and acceptability. Methods A systematic search for randomized controlled trials and prospective cohort studies comparing home-based and clinic-based medical abortion was conducted. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE and Popline were searched. Failure to abort completely, side-effects and acceptability were the main outcomes of interest. Odds ratios and their 95% confidence intervals (CIs) were calculated. Estimates were pooled using a random-effects model. Findings Nine studies met the inclusion criteria (n = 4522 participants). All were prospective cohort studies that used mifepristone and misoprostol to induce abortion. Complete abortion was achieved by 86–97% of the women who underwent home-based abortion (n = 3478) and by 80–99% of those who underwent clinic-based abortion (n = 1044). Pooled analyses from all studies revealed no difference in complete abortion rates between groups (odds ratio = 0.8; 95% CI: 0.5–1.5). Serious complications from abortion were rare. Pain and vomiting lasted 0.3 days longer among women who took misoprostol at home rather than in clinic. Women who chose home-based medical abortion were more likely to be satisfied, to choose the method again and to recommend it to a friend than women who opted for medical abortion in a clinic. Conclusion Home-based abortion is safe under the conditions in place in the included studies. Prospective cohort studies have shown no differences in effectiveness or acceptability between home-based and clinic-based medical abortion across countries. PMID:21556304

  6. Effects of beta-blocker therapy on mortality in patients with heart failure. A systematic overview of randomized controlled trials.

    PubMed

    Doughty, R N; Rodgers, A; Sharpe, N; MacMahon, S

    1997-04-01

    Several randomized trials have reported that beta-blocker therapy improves left ventricular function and reduces the rate of hospitalization in patients with congestive heart failure. However, most trials were individually too small to assess reliably the effects of treatment on mortality. In these circumstances a systematic overview of all trials of beta-blocker therapy in patients with congestive heart failure may provide the most reliable guide to treatment effects. Details were sought from all completed randomized trials of oral beta-blocker therapy in patients with heart failure of any aetiology. In particular, data on mortality were sought from all randomized patients for the scheduled treatment period. The typical effect of treatment on mortality was estimated from an overview in which the results of all individual trials were combined using standard statistical methods. Twenty-four randomized trials, involving 3141 patients with stable congestive heart failure were identified. Complete data on mortality were obtained from all studies, and a total of 297 deaths were documented during an average of 13 months of follow-up. Overall, there was a 31% reduction in the odds of death among patients assigned a beta-blocker (95% confidence interval 11 to 46%, 2P = 0.0035), representing an absolute reduction in mean annual mortality from 9.7% to 7.5%. The effects on mortality of vasodilating beta-blockers (47% reduction SD 15), principally carvedilol, were non-significantly greater (2P = 0.09) than those of standard agents (18% reduction SD 15), principally metoprolol. Beta-blocker therapy is likely to reduce mortality in patients with heart failure. However, large-scale, long-term randomized trials are still required to confirm and quantify more precisely the benefit suggested by this overview.

  7. Feedback on oral presentations during pediatric clerkships: a randomized controlled trial.

    PubMed

    Sox, Colin M; Dell, Michael; Phillipi, Carrie A; Cabral, Howard J; Vargas, Gabriela; Lewin, Linda O

    2014-11-01

    To measure the effects of participating in structured oral presentation evaluation sessions early in pediatric clerkships on students' subsequent presentations. We conducted a single-blind, 3-arm, cluster randomized controlled trial during pediatric clerkships at Boston University School of Medicine, University of Maryland School of Medicine, Oregon Health & Science University, and Case Western Reserve University School of Medicine. Blocks of students at each school were randomly assigned to experience either (1) no formal presentation feedback (control) or a small-group presentation feedback session early in pediatric clerkships in which students gave live presentations and received feedback from faculty who rated their presentations by using a (2) single-item (simple) or (3) 18-item (detailed) evaluation form. At the clerkship end, overall quality of subjects' presentations was rated by faculty blinded to randomization status, and subjects reported whether their presentations had improved. Analyses included multivariable linear and logistic regressions clustered on clerkship block that controlled for medical school. A total of 476 participants were evenly divided into the 3 arms, which had similar characteristics. Compared with controls, presentation quality was significantly associated with participating in detailed (coefficient: 0.38; 95% confidence interval [CI]: 0.07-0.69) but not simple (coefficient: 0.16; 95% CI: -0.12-0.43) feedback sessions. Similarly, student self-report of presentation improvement was significantly associated with participating in detailed (odds ratio: 2.16; 95% CI: 1.11-4.18] but not simple (odds ratio: 1.89; 95% CI: 0.91-3.93) feedback sessions. Small-group presentation feedback sessions led by faculty using a detailed evaluation form resulted in clerkship students delivering oral presentations of higher quality compared with controls. Copyright © 2014 by the American Academy of Pediatrics.

  8. Is laparoscopic sleeve gastrectomy safer than laparoscopic gastric bypass? a comparison of 30-day complications using the MBSAQIP data registry.

    PubMed

    Kumar, Sandhya B; Hamilton, Barbara C; Wood, Stephanie G; Rogers, Stanley J; Carter, Jonathan T; Lin, Matthew Y

    2018-03-01

    Laparoscopic sleeve gastrectomy (LSG) has become popular due to its technical ease and excellent short-term results. Understanding the risk profile of LSG compared with the gold standard laparoscopic Roux-en-Y gastric bypass (LRYGB) is critical for patient selection. To use traditional regression techniques and random forest classification algorithms to compare LSG with LRYGB using the 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Data Registry. United States. Outcomes were leak, morbidity, and mortality within 30 days. Variable importance was assessed using random forest algorithms. Multivariate models were created in a training set and evaluated on the testing set with receiver operating characteristic curves. The adjusted odds of each outcome were compared. Of 134,142 patients, 93,062 (69%) underwent LSG and 41,080 (31%) underwent LRYGB. One hundred seventy-eight deaths occurred in 96 (.1%) of LSG patients compared with 82 (.2%) of LRYGB patients (P<.001). Morbidity occurred in 8% (5.8% in LSG versus 11.7% in LRYGB, P<.001). Leaks occurred in 1% (.8% in LSG versus 1.6% in LRYGB, P<.001). The most important predictors of all outcomes were body mass index, albumin, and age. In the adjusted multivariate models, LRYGB had higher odds of all complications (leak: odds ratio 2.10, P<.001; morbidity: odds ratio 2.02, P<.001; death: odds ratio 1.64, P<.01). In the Metabolic and Bariatric Surgery Accreditation and Quality Improvements data registry for 2015, LSG had half the risk-adjusted odds of death, serious morbidity, and leak in the first 30 days compared with LRYGB. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  9. Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala.

    PubMed

    Smith-Sivertsen, Tone; Díaz, Esperanza; Pope, Dan; Lie, Rolv T; Díaz, Anaite; McCracken, John; Bakke, Per; Arana, Byron; Smith, Kirk R; Bruce, Nigel

    2009-07-15

    Exposure to household wood smoke from cooking is a risk factor for chronic obstructive lung disease among women in developing countries. The Randomized Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE) is a randomized intervention trial evaluating the respiratory health effects of reducing indoor air pollution from open cooking fires. A total of 504 rural Mayan women in highland Guatemala aged 15-50 years, all using traditional indoor open fires, were randomized to either receive a chimney woodstove (plancha) or continue using the open fire. Assessments of chronic respiratory symptoms and lung function and individual measurements of carbon monoxide exposure were performed at baseline and every 6 months up to 18 months. Use of a plancha significantly reduced carbon monoxide exposure by 61.6%. For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42, 95% confidence interval: 0.25, 0.70). The number of respiratory symptoms reported by the women at each follow-up point was also significantly reduced by the plancha (odds ratio = 0.7, 95% confidence interval: 0.50, 0.97). However, no significant effects on lung function were found after 12-18 months. Reducing indoor air pollution from household biomass burning may relieve symptoms consistent with chronic respiratory tract irritation.

  10. Robotic-assisted versus laparoscopic colorectal surgery: a meta-analysis of four randomized controlled trials

    PubMed Central

    2014-01-01

    Background Robotic-assisted laparoscopy is popularly performed for colorectal disease. The objective of this meta-analysis was to compare the safety and efficacy of robotic-assisted colorectal surgery (RCS) and laparoscopic colorectal surgery (LCS) for colorectal disease based on randomized controlled trial studies. Methods Literature searches of electronic databases (Pubmed, Web of Science, and Cochrane Library) were performed to identify randomized controlled trial studies that compared the clinical or oncologic outcomes of RCS and LCS. This meta-analysis was performed using the Review Manager (RevMan) software (version 5.2) that is provided by the Cochrane Collaboration. The data used were mean differences and odds ratios for continuous and dichotomous variables, respectively. Fixed-effects or random-effects models were adopted according to heterogeneity. Results Four randomized controlled trial studies were identified for this meta-analysis. In total, 110 patients underwent RCS, and 116 patients underwent LCS. The results revealed that estimated blood losses (EBLs), conversion rates and times to the recovery of bowel function were significantly reduced following RCS compared with LCS. There were no significant differences in complication rates, lengths of hospital stays, proximal margins, distal margins or harvested lymph nodes between the two techniques. Conclusions RCS is a promising technique and is a safe and effective alternative to LCS for colorectal surgery. The advantages of RCS include reduced EBLs, lower conversion rates and shorter times to the recovery of bowel function. Further studies are required to define the financial effects of RCS and the effects of RCS on long-term oncologic outcomes. PMID:24767102

  11. Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case-control study.

    PubMed

    MacQueen, Kathleen M; Weaver, Mark A; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-05-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥ 80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV.

  12. Efficacy and tolerability assessment of a topical formulation containing copper sulfate and hypericum perforatum on patients with herpes skin lesions: a comparative, randomized controlled trial.

    PubMed

    Clewell, Amy; Barnes, Matt; Endres, John R; Ahmed, Mansoor; Ghambeer, Daljit K S

    2012-02-01

    Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV. The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use. A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14. Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group. The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.

  13. Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan: A Phase III randomized double-blind vehicle-controlled parallel trial.

    PubMed

    Yang, Chao-Chun; Wong, Tak-Wah; Lee, Chih-Hung; Hong, Chien-Hui; Chang, Chung-Hsing; Lai, Feng-Jie; Lin, Shang-Hung; Chi, Ching-Chi; Lin, Tzu-Kai; Yen, Hsi; Wu, Chin-Han; Sheu, Hamm-Ming; Lan, Cheng-Che E

    2018-06-01

    Currently available topical treatments for actinic keratosis (AK) are associated with substantial side-effects. To evaluate the efficacy and safety of topical SR-T100 gel in treating AK. A multicenter, randomized, double-blinded phase III trial was conducted. Patients with at least two clinically visible AK were enrolled and a punch biopsy was performed on one of the AK to confirm the diagnosis. This study consisted of up to 16-week treatment and 8-week post-treatment periods. Medication was applied daily with occlusive dressing. 123 subjects were recruited and 113 were randomized. 76 subjects were in the SR-T100 and 37 in the vehicle arms. In SR-T100 and vehicle groups, 32.39% and 17.14% of subjects achieved complete clearance, respectively. For 75% partial clearance of lesions, 71.83% and 37.1% of subjects achieved this goal in SR-T100 and vehicle group, respectively. When comparing SR-T100 to vehicle, the odds ratio of complete clearance was 2.14 (p = 0.111), and odds ratio of partial clearance was 4.36 (p < 0.001). Severe local reactions were reported by only one subject using SR-T100. The imitation of the study was that not all the treated AK lesions were confirmed by histopathology. The diagnostic uncertainty may contribute to the high partial clearance rate in the vehicle group since the clinical-diagnosed AK showed higher clearance rate compared to histopathology-confirmed AK. The use of occlusive dressing was another possible explanation for high placebo effects. The results suggested that topical SR-T100 gel may be an effective and safe treatment for field therapy of AK. Copyright © 2018 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.

  14. Language of publication restrictions in systematic reviews gave different results depending on whether the intervention was conventional or complementary.

    PubMed

    Pham, Ba'; Klassen, Terry P; Lawson, Margaret L; Moher, David

    2005-08-01

    To assess whether language of publication restrictions impact the estimates of an intervention's effectiveness, whether such impact is similar for conventional medicine and complementary medicine interventions, and whether the results are influenced by publication bias and statistical heterogeneity. We set out to examine the extent to which including reports of randomized controlled trials (RCTs) in languages other than English (LOE) influences the results of systematic reviews, using a broad dataset of 42 language-inclusive systematic reviews, involving 662 RCTs, including both conventional medicine (CM) and complementary and alternative medicine (CAM) interventions. For CM interventions, language-restricted systematic reviews, compared with language-inclusive ones, did not introduce biased results, in terms of estimates of intervention effectiveness (random effects ration of odds rations ROR=1.02; 95% CI=0.83-1.26). For CAM interventions, however, language-restricted systematic reviews resulted in a 63% smaller protective effect estimate than language-inclusive reviews (random effects ROR=1.63; 95% CI=1.03-2.60). Language restrictions do not change the results of CM systematic reviews but do substantially alter the results of CAM systematic reviews. These findings are robust even after sensitivity analyses, and do not appear to be influenced by statistical heterogeneity and publication bias.

  15. Assessing the pro-poor effect of different contracting schemes for health services on health facilities in rural Afghanistan.

    PubMed

    Alonge, Olakunle; Gupta, Shivam; Engineer, Cyrus; Salehi, Ahmad Shah; Peters, David H

    2015-12-01

    Despite progress in improving health outcomes in Afghanistan by contracting public health services through non-governmental organizations (NGOs), inequity in access persists between the poor and non-poor. This study examined the distributive effect of different contracting types on primary health services provision between the poor and non-poor in rural Afghanistan. Contracts to NGOs were made to deliver a common set of primary care services in each province, with the funding agencies determining contract terms. The contracting approaches could be classified into three contracting out types (CO-1, CO-2 and CO-3) and a contracting-in (CI) approach based on the contract terms, design and implementation. Exit interviews of patients attending randomly sampled primary health facilities were collected through systematic sampling across 28 provinces at two time points. The outcome, the odds that a client attending a health facility is poor, was modelled using logistic regression with a robust variance estimator, and the effect of contracting was estimated using the difference-in-difference approach combined with stratified analyses. The sample covered 5960 interviews from 306 health facilities in 2005 and 2008. The adjusted odds of a poor client attending a health facility over time increased significantly for facilities under CO-1 and CO-2, with odds ratio of 2.82 (1.49, 5.36) P-value 0.001 and 2.00 (1.33, 3.02) P-value 0.001, respectively. The odds ratios for those under CO-3 and CI were not statistically significantly different over time. When compared with the non-contracting facilities, the adjusted ratio of odds ratios of poor status among clients was significantly higher for only those under CO-1, ratio of 2.50 (1.32, 4.74) P-value 0.005. CO-1 arrangement which allows contractors to decide on how funds are allocated within a fixed lump sum with non-negotiable deliverables, and actively managed through an independent government agency, is effective in improving equity of health services provision. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2014; all rights reserved.

  16. Comparative survival analysis of adjuvant therapy with iodine-131-labeled lipiodol to hepatic resection of primary hepatocellular carcinoma: a meta-analysis.

    PubMed

    Gong, Lin; Shi, Lu; Sun, Jing; Yuan, Wei-Sheng; Chen, Jian-Feng; Liu, Peng; Gong, Feng; Dong, Jia-Hong

    2014-05-01

    Adjuvant therapies play an important role in delaying the recurrence of hepatocellular carcinoma (HCC) in patients with resectable tumor. Among the available options, use of radionuclides is an effective strategy. This meta-analysis aims to examine the evidence pertaining to the effectiveness of adjuvant therapy with intra-arterial iodine-131-labeled lipiodol ((131)I-lipiodol) to hepatic resection of HCC. A literature survey was conducted of multiple electronic databases including PubMed/Medline, Embase, CINAHL, Cochrane library, and Google Scholar using various combinations of the most relevant key terms. The odds ratio-based meta-analysis of recurrence and survival rates was performed with RevMan software (version 5.2) using a random-effect model. Heterogeneity was assessed by χ(2) and I(2) statistics. When compared with the resection-only group, recurrence rates at 2 and 5 years were significantly lower in patients who received adjuvant therapy with intra-arterial I-lipiodol, with a corresponding odds ratio (95% confidence interval) of 0.45 (0.29-0.70) and 0.52 (0.32-0.85), respectively. The 3- and 5-year overall survival rates were found to be significantly higher in patients who received adjuvant therapy with (131)I-lipiodol than in patients who were not given any adjuvant therapy. Between-study statistical heterogeneity was moderate. Postoperative adjuvant therapy with intra-arterial (131)I-lipiodol to hepatic resection of HCC significantly improves overall and disease-free survival rates and reduces recurrence rates. However, well-designed randomized trials are needed to arrive at conclusive evidence.

  17. NARRATIVE AND META-ANALYTIC REVIEW OF INTERVENTIONS AIMING TO IMPROVE MATERNAL-CHILD ATTACHMENT SECURITY.

    PubMed

    Letourneau, Nicole; Tryphonopoulos, Panagiota; Giesbrecht, Gerald; Dennis, Cindy-Lee; Bhogal, Sanjit; Watson, Barry

    2015-01-01

    Early secure maternal-child attachment relationships lay the foundation for children's healthy social and mental development. Interventions targeting maternal sensitivity and maternal reflective function during the first year of infant life may be the key to promoting secure attachment. We conducted a narrative systematic review and meta-analysis to examine the effectiveness of interventions aimed at promoting maternal sensitivity and reflective function on maternal-child attachment security, as measured by the gold standard Strange Situation (M. Ainsworth, M. Blehar, B. Waters, & S. Wall, 1978) and Q-set (E. Waters & K. Deane, 1985). Studies were identified from electronic database searches and included randomized or quasi-randomized controlled parallel-group designs. Participants were mothers and their infants who were followed up to 36 months' postpartum. Ten trials, involving 1,628 mother-infant pairs, were included. Examination of the trials that provided sufficient data for combination in meta-analysis revealed that interventions of both types increased the odds of secure maternal-child attachment, as compared with no intervention or standard intervention (n = 7 trials; odds ratio: 2.77; 95% confidence interval: 1.69, 4.53, n = 965). Of the three trials not included in the meta-analyses, two improved the likelihood of secure attachment. We conclude that interventions aimed at improving maternal sensitivity alone or in combination with maternal reflection, implemented in the first year of infants' lives, are effective in promoting secure maternal-child attachments. Intervention aimed at the highest risk families produced the most beneficial effects. © 2015 Michigan Association for Infant Mental Health.

  18. Dietary Inflammatory Potential Score and Risk of Breast Cancer: Systematic Review and Meta-analysis.

    PubMed

    Zahedi, Hoda; Djalalinia, Shirin; Sadeghi, Omid; Asayesh, Hamid; Noroozi, Mehdi; Gorabi, Armita Mahdavi; Mohammadi, Rasool; Qorbani, Mostafa

    2018-02-07

    Several studies have been conducted on the relationship between dietary inflammatory potential (DIP) and breast cancer. However, the findings are conflicting. This systematic review and meta-analysis summarizes the findings on the association between DIP and the risk of breast cancer. We used relevant keywords and searched online international electronic databases, including PubMed and NLM Gateway (for Medline), Institute for Scientific Information (ISI), and Scopus for articles published through February 2017. All cross-sectional, case-control, and cohort studies were included in this meta-analysis. Meta-analysis was performed using the random effects meta-analysis method to address heterogeneity among studies. Findings were analyzed statistically. Nine studies were included in the present systematic review and meta-analysis. The total sample size of these studies was 296,102, and the number of participants varied from 1453 to 122,788. The random effects meta-analysis showed a positive and significant association between DIP and the risk of breast cancer (pooled odds ratio, 1.14; 95% confidence interval, 1.01-1.27). The pooled effect size was not statistically significant because of the type of studies, including cohort (pooled relative risk, 1.04; 95% confidence interval, 0.98-1.10) and case-control (pooled odds ratio, 1.63; 95% confidence interval, 0.89-2.37) studies. We found a significant and positive association between higher DIP score and risk of breast cancer. Modifying inflammatory characteristics of diet can substantially reduce the risk of breast cancer. Copyright © 2018 Elsevier Inc. All rights reserved.

  19. Lack of replication of thirteen single-nucleotide polymorphisms implicated in Parkinson’s disease: a large-scale international study

    PubMed Central

    Elbaz, Alexis; Nelson, Lorene M; Payami, Haydeh; Ioannidis, John P A; Fiske, Brian K; Annesi, Grazia; Belin, Andrea Carmine; Factor, Stewart A; Ferrarese, Carlo; Hadjigeorgiou, Georgios M; Higgins, Donald S; Kawakami, Hideshi; Krüger, Rejko; Marder, Karen S; Mayeux, Richard P; Mellick, George D; Nutt, John G; Ritz, Beate; Samii, Ali; Tanner, Caroline M; Van Broeckhoven, Christine; Van Den Eeden, Stephen K; Wirdefeldt, Karin; Zabetian, Cyrus P; Dehem, Marie; Montimurro, Jennifer S; Southwick, Audrey; Myers, Richard M; Trikalinos, Thomas A

    2013-01-01

    Summary Background A genome-wide association study identified 13 single-nucleotide polymorphisms (SNPs) significantly associated with Parkinson’s disease. Small-scale replication studies were largely non-confirmatory, but a meta-analysis that included data from the original study could not exclude all SNP associations, leaving relevance of several markers uncertain. Methods Investigators from three Michael J Fox Foundation for Parkinson’s Research-funded genetics consortia—comprising 14 teams—contributed DNA samples from 5526 patients with Parkinson’s disease and 6682 controls, which were genotyped for the 13 SNPs. Most (88%) participants were of white, non-Hispanic descent. We assessed log-additive genetic effects using fixed and random effects models stratified by team and ethnic origin, and tested for heterogeneity across strata. A meta-analysis was undertaken that incorporated data from the original genome-wide study as well as subsequent replication studies. Findings In fixed and random-effects models no associations with any of the 13 SNPs were identified (odds ratios 0·89 to 1·09). Heterogeneity between studies and between ethnic groups was low for all SNPs. Subgroup analyses by age at study entry, ethnic origin, sex, and family history did not show any consistent associations. In our meta-analysis, no SNP showed significant association (summary odds ratios 0·95 to 1.08); there was little heterogeneity except for SNP rs7520966. Interpretation Our results do not lend support to the finding that the 13 SNPs reported in the original genome-wide association study are genetic susceptibility factors for Parkinson’s disease. PMID:17052658

  20. Inference for binomial probability based on dependent Bernoulli random variables with applications to meta-analysis and group level studies.

    PubMed

    Bakbergenuly, Ilyas; Kulinskaya, Elena; Morgenthaler, Stephan

    2016-07-01

    We study bias arising as a result of nonlinear transformations of random variables in random or mixed effects models and its effect on inference in group-level studies or in meta-analysis. The findings are illustrated on the example of overdispersed binomial distributions, where we demonstrate considerable biases arising from standard log-odds and arcsine transformations of the estimated probability p̂, both for single-group studies and in combining results from several groups or studies in meta-analysis. Our simulations confirm that these biases are linear in ρ, for small values of ρ, the intracluster correlation coefficient. These biases do not depend on the sample sizes or the number of studies K in a meta-analysis and result in abysmal coverage of the combined effect for large K. We also propose bias-correction for the arcsine transformation. Our simulations demonstrate that this bias-correction works well for small values of the intraclass correlation. The methods are applied to two examples of meta-analyses of prevalence. © 2016 The Authors. Biometrical Journal Published by Wiley-VCH Verlag GmbH & Co. KGaA.

  1. Effect of platelet inhibition with cangrelor during PCI on ischemic events.

    PubMed

    Bhatt, Deepak L; Stone, Gregg W; Mahaffey, Kenneth W; Gibson, C Michael; Steg, P Gabriel; Hamm, Christian W; Price, Matthew J; Leonardi, Sergio; Gallup, Dianne; Bramucci, Ezio; Radke, Peter W; Widimský, Petr; Tousek, Frantisek; Tauth, Jeffrey; Spriggs, Douglas; McLaurin, Brent T; Angiolillo, Dominick J; Généreux, Philippe; Liu, Tiepu; Prats, Jayne; Todd, Meredith; Skerjanec, Simona; White, Harvey D; Harrington, Robert A

    2013-04-04

    The intensity of antiplatelet therapy during percutaneous coronary intervention (PCI) is an important determinant of PCI-related ischemic complications. Cangrelor is a potent intravenous adenosine diphosphate (ADP)-receptor antagonist that acts rapidly and has quickly reversible effects. In a double-blind, placebo-controlled trial, we randomly assigned 11,145 patients who were undergoing either urgent or elective PCI and were receiving guideline-recommended therapy to receive a bolus and infusion of cangrelor or to receive a loading dose of 600 mg or 300 mg of clopidogrel. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours after randomization; the key secondary end point was stent thrombosis at 48 hours. The primary safety end point was severe bleeding at 48 hours. The rate of the primary efficacy end point was 4.7% in the cangrelor group and 5.9% in the clopidogrel group (adjusted odds ratio with cangrelor, 0.78; 95% confidence interval [CI], 0.66 to 0.93; P=0.005). The rate of the primary safety end point was 0.16% in the cangrelor group and 0.11% in the clopidogrel group (odds ratio, 1.50; 95% CI, 0.53 to 4.22; P=0.44). Stent thrombosis developed in 0.8% of the patients in the cangrelor group and in 1.4% in the clopidogrel group (odds ratio, 0.62; 95% CI, 0.43 to 0.90; P=0.01). The rates of adverse events related to the study treatment were low in both groups, though transient dyspnea occurred significantly more frequently with cangrelor than with clopidogrel (1.2% vs. 0.3%). The benefit from cangrelor with respect to the primary end point was consistent across multiple prespecified subgroups. Cangrelor significantly reduced the rate of ischemic events, including stent thrombosis, during PCI, with no significant increase in severe bleeding. (Funded by the Medicines Company; CHAMPION PHOENIX ClinicalTrials.gov number, NCT01156571.).

  2. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    PubMed Central

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  3. Intensity of continuous renal-replacement therapy in critically ill patients.

    PubMed

    Bellomo, Rinaldo; Cass, Alan; Cole, Louise; Finfer, Simon; Gallagher, Martin; Lo, Serigne; McArthur, Colin; McGuinness, Shay; Myburgh, John; Norton, Robyn; Scheinkestel, Carlos; Su, Steve

    2009-10-22

    The optimal intensity of continuous renal-replacement therapy remains unclear. We conducted a multicenter, randomized trial to compare the effect of this therapy, delivered at two different levels of intensity, on 90-day mortality among critically ill patients with acute kidney injury. We randomly assigned critically ill adults with acute kidney injury to continuous renal-replacement therapy in the form of postdilution continuous venovenous hemodiafiltration with an effluent flow of either 40 ml per kilogram of body weight per hour (higher intensity) or 25 ml per kilogram per hour (lower intensity). The primary outcome measure was death within 90 days after randomization. Of the 1508 enrolled patients, 747 were randomly assigned to higher-intensity therapy, and 761 to lower-intensity therapy with continuous venovenous hemodiafiltration. Data on primary outcomes were available for 1464 patients (97.1%): 721 in the higher-intensity group and 743 in the lower-intensity group. The two study groups had similar baseline characteristics and received the study treatment for an average of 6.3 and 5.9 days, respectively (P=0.35). At 90 days after randomization, 322 deaths had occurred in the higher-intensity group and 332 deaths in the lower-intensity group, for a mortality of 44.7% in each group (odds ratio, 1.00; 95% confidence interval [CI], 0.81 to 1.23; P=0.99). At 90 days, 6.8% of survivors in the higher-intensity group (27 of 399), as compared with 4.4% of survivors in the lower-intensity group (18 of 411), were still receiving renal-replacement therapy (odds ratio, 1.59; 95% CI, 0.86 to 2.92; P=0.14). Hypophosphatemia was more common in the higher-intensity group than in the lower-intensity group (65% vs. 54%, P<0.001). In critically ill patients with acute kidney injury, treatment with higher-intensity continuous renal-replacement therapy did not reduce mortality at 90 days. (ClinicalTrials.gov number, NCT00221013.) 2009 Massachusetts Medical Society

  4. Minimal intervention dentistry for early childhood caries and child dental anxiety: a randomized controlled trial.

    PubMed

    Arrow, P; Klobas, E

    2017-06-01

    To compare changes in child dental anxiety after treatment for early childhood caries (ECC) using two treatment approaches. Children with ECC were randomized to test (atraumatic restorative treatment (ART)-based approach) or control (standard care approach) groups. Children aged 3 years or older completed a dental anxiety scale at baseline and follow up. Changes in child dental anxiety from baseline to follow up were tested using the chi-squared statistic, Wilcoxon rank sum test, McNemar's test and multinomial logistic regression. Two hundred and fifty-four children were randomized (N = 127 test, N = 127 control). At baseline, 193 children completed the dental anxiety scale, 211 at follow up and 170 completed the scale on both occasions. Children who were anxious at baseline (11%) were no longer anxious at follow up, and 11% non-anxious children became anxious. Multinomial logistic regression found each increment in the number of visits increased the odds of worsening dental anxiety (odds ratio (OR), 2.2; P < 0.05), whereas each increment in the number of treatments lowered the odds of worsening anxiety (OR, 0.50; P = 0.05). The ART-based approach to managing ECC resulted in similar levels of dental anxiety to the standard treatment approach and provides a valuable alternative approach to the management of ECC in a primary dental care setting. © 2016 Australian Dental Association.

  5. Meta-Analysis of Drainage Versus No Drainage After Laparoscopic Cholecystectomy

    PubMed Central

    Lucarelli, Pierino; Di Filippo, Annalisa; De Angelis, Francesco; Stipa, Francesco; Spaziani, Erasmo

    2014-01-01

    Background and Objectives: Routine drainage after laparoscopic cholecystectomy is still controversial. This meta-analysis was performed to assess the role of drains in reducing complications in laparoscopic cholecystectomy. Methods: An electronic search of Medline, Science Citation Index Expanded, Scopus, and the Cochrane Library database from January 1990 to June 2013 was performed to identify randomized clinical trials that compare prophylactic drainage with no drainage in laparoscopic cholecystectomy. The odds ratio for qualitative variables and standardized mean difference for continuous variables were calculated. Results: Twelve randomized controlled trials were included in the meta-analysis, involving 1939 patients randomized to a drain (960) versus no drain (979). The morbidity rate was lower in the no drain group (odds ratio, 1.97; 95% confidence interval, 1.26 to 3.10; P = .003). The wound infection rate was lower in the no drain group (odds ratio, 2.35; 95% confidence interval, 1.22 to 4.51; P = .01). Abdominal pain 24 hours after surgery was less severe in the no drain group (standardized mean difference, 2.30; 95% confidence interval, 1.27 to 3.34; P < .0001). No significant difference was present with respect to the presence and quantity of subhepatic fluid collection, shoulder tip pain, parenteral ketorolac consumption, nausea, vomiting, and hospital stay. Conclusion: This study was unable to prove that drains were useful in reducing complications in laparoscopic cholecystectomy. PMID:25516708

  6. A randomized controlled trial of intensive care management for disabled Medicaid beneficiaries with high health care costs.

    PubMed

    Bell, Janice F; Krupski, Antoinette; Joesch, Jutta M; West, Imara I; Atkins, David C; Court, Beverly; Mancuso, David; Roy-Byrne, Peter

    2015-06-01

    To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs. Washington State Department of Social and Health Services Client Outcomes Database, 2008-2011. In a randomized controlled trial with intent-to-treat analysis, outcomes were compared for the intervention (n = 557) and control groups (n = 563). A quasi-experimental subanalysis compared outcomes for program participants (n = 251) and propensity score-matched controls (n = 251). Administrative data were linked to describe costs and use of health services, criminal activity, homelessness, and death. In the intent-to-treat analysis, the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod. In the subanalysis, participants had fewer unplanned hospital admissions and lower associated costs; higher prescription drug costs; higher odds of long-term care service use; higher drug/alcohol treatment costs; and lower odds of homelessness. We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management. Among participants, care management may have the potential to increase access to needed care, slow growth in the number and therefore cost of unplanned hospitalizations, and prevent homelessness. These findings apply to start-up care management programs targeted at high-cost, high-risk Medicaid populations. © Health Research and Educational Trust.

  7. A utility-based design for randomized comparative trials with ordinal outcomes and prognostic subgroups.

    PubMed

    Murray, Thomas A; Yuan, Ying; Thall, Peter F; Elizondo, Joan H; Hofstetter, Wayne L

    2018-01-22

    A design is proposed for randomized comparative trials with ordinal outcomes and prognostic subgroups. The design accounts for patient heterogeneity by allowing possibly different comparative conclusions within subgroups. The comparative testing criterion is based on utilities for the levels of the ordinal outcome and a Bayesian probability model. Designs based on two alternative models that include treatment-subgroup interactions are considered, the proportional odds model and a non-proportional odds model with a hierarchical prior that shrinks toward the proportional odds model. A third design that assumes homogeneity and ignores possible treatment-subgroup interactions also is considered. The three approaches are applied to construct group sequential designs for a trial of nutritional prehabilitation versus standard of care for esophageal cancer patients undergoing chemoradiation and surgery, including both untreated patients and salvage patients whose disease has recurred following previous therapy. A simulation study is presented that compares the three designs, including evaluation of within-subgroup type I and II error probabilities under a variety of scenarios including different combinations of treatment-subgroup interactions. © 2018, The International Biometric Society.

  8. Child hunger and the protective effects of supplemental nutrition assistance program (SNAP) and alternative food sources among Mexican-origin families in Texas border colonias

    PubMed Central

    2013-01-01

    Background Nutritional health is essential for children’s growth and development. Many Mexican-origin children who reside in limited-resource colonias along the Texas-Mexico border are at increased risk for poor nutrition as a result of household food insecurity. However, little is known about the prevalence of child hunger or its associated factors among children of Mexican immigrants. This study determines the prevalence of child hunger and identifies protective and risk factors associated with it in two Texas border areas. Methods This study uses 2009 Colonia Household and Community Food Resource Assessment (C-HCFRA) data from 470 mothers who were randomly recruited by promotora-researchers. Participants from colonias near two small towns in two South Texas counties participated in an in-home community and household assessment. Interviewer-administered surveys collected data in Spanish on sociodemographics, federal food assistance program participation, and food security status. Frequencies and bivariate correlations were examined while a random-effects logistic regression model with backward elimination was used to determine correlates of childhood hunger. Results Hunger among children was reported in 51% (n = 239) of households in this C-HCFRA sample. Bivariate analyses revealed that hunger status was associated with select maternal characteristics, such as lower educational attainment and Mexican nativity, and household characteristics, including household composition, reliance on friend or neighbor for transportation, food purchase at dollar stores and from neighbors, and participation in school-based nutrition programs. A smaller percentage of households with child hunger participated in school-based nutrition programs (51%) or used alternative food sources, while 131 households were unable to give their child or children a balanced meal during the school year and 145 households during summer months. In the random effects model (RE = small town), increased household composition, full-time unemployment, and participation in the National School Lunch Program were significantly associated with increased odds for child hunger, while participation in Supplemental Nutrition Assistance Program (SNAP) and purchasing food from a neighbor were significantly associated with decreased odds for child hunger. Conclusions This study not only emphasizes the alarming rates of child hunger among this sample of Mexican-origin families, but also identifies economic and family factors that increased the odds for child hunger as well as community strategies that reduced the odds. It is unsettling that so many children did not participate in school-based nutrition programs, and that many who participated in federal nutrition assistance programs remained hungry. This study underscores the importance of identifying the presence of child hunger among low-income Mexican-origin children in Texas border colonias and increasing access to nutrition-related resources. Hunger-associated health inequities at younger ages among colonia residents are likely to persist across the life span and into old age. PMID:24034599

  9. Child hunger and the protective effects of Supplemental Nutrition Assistance Program (SNAP) and alternative food sources among Mexican-origin families in Texas border colonias.

    PubMed

    Sharkey, Joseph R; Dean, Wesley R; Nalty, Courtney C

    2013-09-13

    Nutritional health is essential for children's growth and development. Many Mexican-origin children who reside in limited-resource colonias along the Texas-Mexico border are at increased risk for poor nutrition as a result of household food insecurity. However, little is known about the prevalence of child hunger or its associated factors among children of Mexican immigrants. This study determines the prevalence of child hunger and identifies protective and risk factors associated with it in two Texas border areas. This study uses 2009 Colonia Household and Community Food Resource Assessment (C-HCFRA) data from 470 mothers who were randomly recruited by promotora-researchers. Participants from colonias near two small towns in two South Texas counties participated in an in-home community and household assessment. Interviewer-administered surveys collected data in Spanish on sociodemographics, federal food assistance program participation, and food security status. Frequencies and bivariate correlations were examined while a random-effects logistic regression model with backward elimination was used to determine correlates of childhood hunger. Hunger among children was reported in 51% (n = 239) of households in this C-HCFRA sample. Bivariate analyses revealed that hunger status was associated with select maternal characteristics, such as lower educational attainment and Mexican nativity, and household characteristics, including household composition, reliance on friend or neighbor for transportation, food purchase at dollar stores and from neighbors, and participation in school-based nutrition programs. A smaller percentage of households with child hunger participated in school-based nutrition programs (51%) or used alternative food sources, while 131 households were unable to give their child or children a balanced meal during the school year and 145 households during summer months. In the random effects model (RE = small town), increased household composition, full-time unemployment, and participation in the National School Lunch Program were significantly associated with increased odds for child hunger, while participation in Supplemental Nutrition Assistance Program (SNAP) and purchasing food from a neighbor were significantly associated with decreased odds for child hunger. This study not only emphasizes the alarming rates of child hunger among this sample of Mexican-origin families, but also identifies economic and family factors that increased the odds for child hunger as well as community strategies that reduced the odds. It is unsettling that so many children did not participate in school-based nutrition programs, and that many who participated in federal nutrition assistance programs remained hungry. This study underscores the importance of identifying the presence of child hunger among low-income Mexican-origin children in Texas border colonias and increasing access to nutrition-related resources. Hunger-associated health inequities at younger ages among colonia residents are likely to persist across the life span and into old age.

  10. Bayesian analysis of longitudinal dyadic data with informative missing data using a dyadic shared-parameter model.

    PubMed

    Ahn, Jaeil; Morita, Satoshi; Wang, Wenyi; Yuan, Ying

    2017-01-01

    Analyzing longitudinal dyadic data is a challenging task due to the complicated correlations from repeated measurements and within-dyad interdependence, as well as potentially informative (or non-ignorable) missing data. We propose a dyadic shared-parameter model to analyze longitudinal dyadic data with ordinal outcomes and informative intermittent missing data and dropouts. We model the longitudinal measurement process using a proportional odds model, which accommodates the within-dyad interdependence using the concept of the actor-partner interdependence effects, as well as dyad-specific random effects. We model informative dropouts and intermittent missing data using a transition model, which shares the same set of random effects as the longitudinal measurement model. We evaluate the performance of the proposed method through extensive simulation studies. As our approach relies on some untestable assumptions on the missing data mechanism, we perform sensitivity analyses to evaluate how the analysis results change when the missing data mechanism is misspecified. We demonstrate our method using a longitudinal dyadic study of metastatic breast cancer.

  11. Internet-Based Programs Incorporating Behavior Change Techniques Are Associated With Increased Smoking Cessation in the General Population: A Systematic Review and Meta-analysis.

    PubMed

    McCrabb, Sam; Baker, Amanda L; Attia, John; Skelton, Eliza; Twyman, Laura; Palazzi, Kerrin; McCarter, Kristen; Ku, Dominic; Bonevski, Billie

    2018-05-10

    This study aims to (i) examine the effectiveness of internet-based smoking cessation programs; (ii) describe the number and type of behavior change techniques (BCTs) employed; and (iii) explore whether BCTs included in internet-based smoking cessation programs are related to program effectiveness. MEDLINE, CINAHL, EMBASE, PsycINFO, and CENTRAL databases were searched. Randomized controlled trials were included if they described the study of a smoking cessation program delivered via the internet; included current adult tobacco smokers from the general population; and were written in English. Random effects meta-analyses and meta-regressions were used to examine program effectiveness (pooled odds ratios, by outcome measure, i.e., 7 day point prevalence abstinence [PPA], 30 day PPA, other abstinence measure) in short- and long-term outcomes, and examine the associations between BCT number and type (individual BCTs and BCT domain) and program effectiveness. Results from 45 studies were included (n = 65,736). Intervention effectiveness was found in the short term for all outcome measures (OR = 1.29, 95% CI 1.12, 1.50, p = .001), for "prolonged abstinence" (OR = 1.43, 95% CI 1.09, 1.87, p = .009), and "30 day PPA" (OR = 1.75, 95% CI 1.13, 2.72, p = .013). Internet-based programs were effective in the long term for all outcome measures (OR = 1.19, 95% CI = 1.06, 1.35, p = .004) and for "prolonged abstinence" (OR = 1.40, 95% CI 1.19, 1.63, p < .001). On average, interventions used more BCTs than comparison groups (6.6 vs. 3.1, p = .0002). The impact of specific individual BCTs and BCT domains on effectiveness was examined and is reported. Internet-based smoking cessation interventions increased the odds of cessation by 29 per cent in the short term and by 19 per cent in the long term. Internet-based smoking cessation intervention development should incorporate BCTs to increase effectiveness. CRD42015014676.

  12. Internet-delivered Treatment for Substance Abuse: A Multi-site Randomized Controlled Clinical Trial

    PubMed Central

    Campbell, Aimee N. C.; Nunes, Edward V.; Matthews, Abigail G.; Stitzer, Maxine; Miele, Gloria M.; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A.; Kyle, Tiffany L.; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E.

    2014-01-01

    Objective Drug and alcohol abuse constitutes a major public health problem. Computer-delivered interventions have potential to improve access to quality care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System, an internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Method Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to 12-weeks of treatment-as-usual (n=252) or treatment-as-usual + Therapeutic Education System, whereby the intervention substituted for 2 hours of standard care per week (n=255). Therapeutic Education System consists of 62 computer-interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment-as-usual consisted of individual and group counseling at the participating programs. Primary outcomes were (1) abstinence from drugs and heavy drinking measured by twice weekly urine drug screens and self-report, and (2) time to drop-out from treatment. Results Compared to treatment-as-usual, those receiving Therapeutic Education System reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003). Conclusion Internet-delivered interventions, such as Therapeutic Education System, have the potential to expand access and improve addiction treatment outcomes; additional research is needed to assess effectiveness in non-specialty clinical systems and to differentiate the effect of Community Reinforcement Approach and Contingency Management. PMID:24700332

  13. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial.

    PubMed

    Campbell, Aimee N C; Nunes, Edward V; Matthews, Abigail G; Stitzer, Maxine; Miele, Gloria M; Polsky, Daniel; Turrigiano, Eva; Walters, Scott; McClure, Erin A; Kyle, Tiffany L; Wahle, Aimee; Van Veldhuisen, Paul; Goldman, Bruce; Babcock, Dean; Stabile, Patricia Quinn; Winhusen, Theresa; Ghitza, Udi E

    2014-06-01

    Computer-delivered interventions have the potential to improve access to quality addiction treatment care. The objective of this study was to evaluate the effectiveness of the Therapeutic Education System (TES), an Internet-delivered behavioral intervention that includes motivational incentives, as a clinician-extender in the treatment of substance use disorders. Adult men and women (N=507) entering 10 outpatient addiction treatment programs were randomly assigned to receive 12 weeks of either treatment as usual (N=252) or treatment as usual plus TES, with the intervention substituting for about 2 hours of standard care per week (N=255). TES consists of 62 computerized interactive modules covering skills for achieving and maintaining abstinence, plus prize-based motivational incentives contingent on abstinence and treatment adherence. Treatment as usual consisted of individual and group counseling at the participating programs. The primary outcome measures were abstinence from drugs and heavy drinking (measured by twice-weekly urine drug screens and self-report) and time to dropout from treatment. Compared with patients in the treatment-as-usual group, those in the TES group had a lower dropout rate (hazard ratio=0.72, 95% CI=0.57, 0.92) and a greater abstinence rate (odds ratio=1.62, 95% CI=1.12, 2.35). This effect was more pronounced among patients who had a positive urine drug or breath alcohol screen at study entry (N=228) (odds ratio=2.18, 95% CI=1.30, 3.68). Internet-delivered interventions such as TES have the potential to expand access and improve addiction treatment outcomes. Additional research is needed to assess effectiveness in non-specialty clinical settings and to differentiate the effects of the community reinforcement approach and contingency management components of TES.

  14. Drug therapy for solitary cysticercus granuloma

    PubMed Central

    Singla, Monika; Sander, Josemir W.; Singh, Gagandeep

    2013-01-01

    Objective: The effectiveness of anthelminthic and corticosteroid drug therapy in parenchymal neurocysticercosis is well established. The treatment of parenchymal solitary cysticercus granuloma (SCG), however, remains controversial. We attempted to obtain a consistent estimate of the efficacy of anthelminthic and corticosteroid drug treatment in SCG. Methods: Randomized-controlled trials (RCTs) comparing rates of seizure freedom, granuloma resolution, and residual calcification in individuals with SCG treated with anthelminthic or corticosteroid drugs with those treated with antiepileptic drugs (AEDs) alone were systematically reviewed and quantified using fixed- or random-effects meta-analysis. Results: Fifteen RCTs were identified for inclusion. Ten RCTs assigned 765 people with SCG to AED treatment with or without anthelminthic drug (albendazole) treatment. A further 5 RCTs assigned 457 people with SCG to AED treatment with or without corticosteroid drugs. Anthelminthic treatment was associated with significantly increased rates of seizure freedom (nonevent odds ratio: 2.45; 95% confidence interval: 1.49–4.03; p = 0.0004) and significantly higher rates of granuloma resolution (odds ratio: 2.09; 95% confidence interval: 1.41–3.00; p = 0.0003), but did not alter the risk of residual calcification. Corticosteroid treatment was not significantly associated with any outcome. Conclusions: Anthelminthic treatment with albendazole provides improved rates of seizure freedom and hastens resolution of the granuloma. The role of corticosteroid treatment remains uncertain. The benefits (or lack thereof in the case of corticosteroids) are consistent when measured across different time points after treatment. PMID:23269591

  15. Social relationships and longitudinal changes in body mass index and waist circumference: the coronary artery risk development in young adults study.

    PubMed

    Kershaw, Kiarri N; Hankinson, Arlene L; Liu, Kiang; Reis, Jared P; Lewis, Cora E; Loria, Catherine M; Carnethon, Mercedes R

    2014-03-01

    Few studies have examined longitudinal associations between close social relationships and weight change. Using data from 3,074 participants in the Coronary Artery Risk Development in Young Adults Study who were examined in 2000, 2005, and 2010 (at ages 33-45 years in 2000), we estimated separate logistic regression random-effects models to assess whether patterns of exposure to supportive and negative relationships were associated with 10% or greater increases in body mass index (BMI) (weight (kg)/height (m)(2)) and waist circumference. Linear regression random-effects modeling was used to examine associations of social relationships with mean changes in BMI and waist circumference. Participants with persistently high supportive relationships were significantly less likely to increase their BMI values and waist circumference by 10% or greater compared with those with persistently low supportive relationships after adjustment for sociodemographic characteristics, baseline BMI/waist circumference, depressive symptoms, and health behaviors. Persistently high negative relationships were associated with higher likelihood of 10% or greater increases in waist circumference (odds ratio = 1.62, 95% confidence interval: 1.15, 2.29) and marginally higher BMI increases (odds ratio = 1.50, 95% confidence interval: 1.00, 2.24) compared with participants with persistently low negative relationships. Increasingly negative relationships were associated with increases in waist circumference only. These findings suggest that supportive relationships may minimize weight gain, and that adverse relationships may contribute to weight gain, particularly via central fat accumulation.

  16. Social Relationships and Longitudinal Changes in Body Mass Index and Waist Circumference: The Coronary Artery Risk Development in Young Adults Study

    PubMed Central

    Kershaw, Kiarri N.; Hankinson, Arlene L.; Liu, Kiang; Reis, Jared P.; Lewis, Cora E.; Loria, Catherine M.; Carnethon, Mercedes R.

    2014-01-01

    Few studies have examined longitudinal associations between close social relationships and weight change. Using data from 3,074 participants in the Coronary Artery Risk Development in Young Adults Study who were examined in 2000, 2005, and 2010 (at ages 33–45 years in 2000), we estimated separate logistic regression random-effects models to assess whether patterns of exposure to supportive and negative relationships were associated with 10% or greater increases in body mass index (BMI) (weight (kg)/height (m)2) and waist circumference. Linear regression random-effects modeling was used to examine associations of social relationships with mean changes in BMI and waist circumference. Participants with persistently high supportive relationships were significantly less likely to increase their BMI values and waist circumference by 10% or greater compared with those with persistently low supportive relationships after adjustment for sociodemographic characteristics, baseline BMI/waist circumference, depressive symptoms, and health behaviors. Persistently high negative relationships were associated with higher likelihood of 10% or greater increases in waist circumference (odds ratio = 1.62, 95% confidence interval: 1.15, 2.29) and marginally higher BMI increases (odds ratio = 1.50, 95% confidence interval: 1.00, 2.24) compared with participants with persistently low negative relationships. Increasingly negative relationships were associated with increases in waist circumference only. These findings suggest that supportive relationships may minimize weight gain, and that adverse relationships may contribute to weight gain, particularly via central fat accumulation. PMID:24389018

  17. The Association Between Atopy and Childhood/Adolescent Leukemia: A Meta-Analysis

    PubMed Central

    Linabery, Amy M.; Jurek, Anne M.; Duval, Sue; Ross, Julie A.

    2010-01-01

    Atopic disease is hypothesized to be protective against several malignancies, including childhood/adolescent leukemia. To summarize the available epidemiologic evidence, the authors performed a meta-analysis of associations between atopy/allergies, asthma, eczema, hay fever, and hives and childhood/adolescent leukemia, acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML). They searched MEDLINE literature (1952–March 2009) and queried international experts to identify eligible studies. Ten case-control studies were included. Summary odds ratios and 95% confidence intervals were computed via random-effects models. Odds ratios for atopy/allergies were 1.42 (95% confidence interval (CI): 0.60, 3.35) for 3 studies of leukemia overall, 0.69 (95% CI: 0.54, 0.89) for 6 studies of ALL, and 0.87 (95% CI: 0.62, 1.22) for 2 studies of AML, with high levels of heterogeneity detected for leukemia overall and ALL. Inverse associations were observed for ALL and asthma (odds ratio (OR) = 0.79, 95% CI: 0.61, 1.02), eczema (OR = 0.74, 95% CI: 0.58, 0.96), and hay fever (OR = 0.55, 95% CI: 0.46, 0.66) examined separately. Odds ratios for ALL differed by study design, exposure data source, and latency period, indicating that these factors affect study results. These results should be interpreted cautiously given the modest number of studies, substantial heterogeneity, and potential exposure misclassification but are useful in designing future research. PMID:20228139

  18. The effectiveness of alcohol policies in 4-year public universities.

    PubMed

    Walter, Gayle; Kowalczyk, John

    2012-04-01

    The objective of this study was to evaluate the type of alcohol policy in place in 4-year public universities against the odds of heavy drinking. Data was collected during the months of April-June 2010 using the Core Alcohol and Drug Survey. The participants included a random sample of undergraduate students from 4 public universities in the Midwest. Two of the universities had policies in place allowing the sale and use of alcohol on campus, and 2 universities had policies in place prohibiting the sale and use of alcohol. There were a total of 186 participants which included 63 males and 123 females. There was statistical significance in gender, age, and participation in sports against the odds of heavy drinking (P < .05). The type of policy in place was not significantly associated with the odds of heavy drinking. Even though there was an association between gender, age, and participation in sports with the odds of heavy drinking among college students in this sample, the type of alcohol policy (wet or dry) had no association. The results demonstrate the need for the implementation of alcohol prevention strategies, in addition to policy, to reduce the number of college students who drink heavily. It may be beneficial to target those alcohol intervention programs to the high risk groups such as males, over the age of 21, and those students who participate in sports.

  19. Glucose-6-phosphate dehydrogenase deficiency and risk of diabetes: a systematic review and meta-analysis.

    PubMed

    Lai, Yin Key; Lai, Nai Ming; Lee, Shaun Wen Huey

    2017-05-01

    Emerging epidemiological evidence suggests that patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may have a higher risk of developing diabetes. The aim of the review was to synthesise the evidence on the association between G6PD deficiency and diabetes. A systematic search on Medline, EMBASE, AMED and CENTRAL databases for studies published between January 1966 and September 2016 that assessed the association between G6PD deficiency and diabetes was conducted. This was supplemented by a review of the reference list of retrieved articles. We extracted data on study characteristics, outcomes and performed an assessment on the methodological quality of the studies. A random-effects model was used to compute the summary risk estimates. Fifteen relevant publications involving 949,260 participants were identified, from which seven studies contributed to the meta-analysis. G6PD deficiency was associated with a higher odd of diabetes (odds ratio 2.37, 95% confidence interval 1.50-3.73). The odds ratio of diabetes among men was higher (2.22, 1.31-3.75) compared to women (1.87, 1.12-3.12). This association was broadly consistent in the sensitivity analysis. Current evidence suggests that G6PD deficiency may be a risk factor for diabetes, with higher odds among men compared to women. Further research is needed to determine how G6PD deficiency moderates diabetes.

  20. Evaluating the effectiveness of a patient storytelling DVD intervention to encourage physician-patient communication about nonsteroidal anti-inflammatory drug (NSAID) use.

    PubMed

    Miller, Michael J; Weech-Maldonado, Robert; Outman, Ryan C; Ray, Midge N; Gary, Lisa C; Chen, Lang; Cobaugh, Daniel J; Allison, Jeroan J; Saag, Kenneth G

    2016-11-01

    To evaluate the effectiveness of a culturally-sensitive, patient storytelling intervention to enhance physician-patient communication about NSAID risk. A group randomized trial of 40 medical practices in Alabama was conducted. Patients within intervention practices received a 13-minute DVD that included patient stories related to their experiences with NSAIDs, adverse effects, and importance of communication with their physicians. The proportion of patients who: (1) spoke with their physician about NSAID risk; and (2) used both prescription and over-the-counter (OTC) NSAIDS were primary outcomes. Generalized estimating equations for panel data were used for analysis. Intention-to-treat analyses revealed no significant differences between intervention (n=102) and control (n=106) groups for patients speaking with their physician about NSAID risk or concomitant use of prescription/OTC NSAIDs (Odds Ratio [OR]=1.11, p=0.670; OR=0.87, p=0.632, respectively). For 54% of patients who watched the DVD, per-protocol (PP) analyses trended toward increased odds of patients speaking with their physician about prescription NSAID risk compared to the control group [OR=1.37, p=0.354] and lower odds of concomitant prescription/OTC NSAIDs use [OR=0.79, p=0.486]. A patient storytelling intervention in DVD format alone may not increase patient-physician interaction. Strategies that facilitate use of patient educational materials delivered by DVD are needed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  1. Effect of Oral Carbohydrate Intake on Labor Progress: Randomized Controlled Trial

    PubMed Central

    Rahmani, R; Khakbazan, Z; Yavari, P; Granmayeh, M; Yavari, L

    2012-01-01

    Background Lack of information regarding biochemical changes in women during labor and its outcomes on maternal and neonatal health still is an unanswered question. This study aims to explore the effectiveness of oral carbohydrate intake during labor on the duration of the active phase and other maternal and neonatal outcomes. Methods: A parallel prospective randomized controlled trial, conducted at the University Affiliated Teaching Hospital in Gonabad. Totally, 190 women were randomly assigned to an intervention (N=87) or control (N=90) group. Inclusion criteria were low-risk women with singleton cephalic presentation; and cervical dilatation 3–4 cm. Randomization was used by random number generator on every day. Odd numbers was used for intervention and even numbers for control group. Intervention was based on the preferences between: 3 medium dates plus 110 ml water; 3 dates plus 110 ml light tea without sugar; or 110 ml orange juice. The protocol is only run once but women ate and drank gradually before second stage of labor. Control group were fasted as routine practice. Neither participants nor care givers or staff could be blinded to group allocation. Differences between duration of the active phase of labor were assessed as primary outcome measure. Results: There was significant difference in the length of second stage of labor (P <.05). The effect size for this variable was 0.48. There were no significant differences in other maternal and neonatal outcomes. Conclusions: Oral intake of carbohydrate was an effective method for shortening the duration of second stage of labor in low-risk women. PMID:23304677

  2. Effectiveness of a behavior change communication intervention to improve knowledge and perceptions about abortion in Bihar and Jharkhand, India.

    PubMed

    Banerjee, Sushanta K; Andersen, Kathryn L; Warvadekar, Janardan; Pearson, Erin

    2013-09-01

    Although abortion became legal in India in 1971, many women are unaware of the law. Behavior change communication interventions may be an effective way to promote awareness of the law and change knowledge of and perceptions about abortion, particularly in settings in which abortion is stigmatized. To evaluate the effectiveness of a behavior change communication intervention to improve women's knowledge about India's abortion law and their perceptions about abortion, a quasi-experimental study was conducted in intervention and comparison districts in Bihar and Jharkhand. Household surveys were administered at baseline in 2008 and at follow-up in 2010 to independent, randomly selected cross-sectional samples of rural married women aged 15-49. Logistic regression difference-in-differences models were used to assess program effectiveness. Analysis demonstrated program effectiveness in improving awareness and perceptions about abortion. The changes in the odds of knowing that abortion is legal and where to obtain safe abortion services were larger between baseline and follow-up in the intervention districts than the changes in odds observed in the comparison districts (odds ratios, 16.1 and 1.9, respectively). Similarly, the increase in women's perception of greater social support for abortion within their families and the increase in perceived self-efficacy with respect to family planning and abortion between baseline and follow-up was greater in the intervention districts than in the comparison districts (coefficients, 0.17 and 0.18, respectively). Behavior change communication interventions can be effective in improving knowledge of and perceptions about abortion in settings in which lack of accurate knowledge hinders women's access to safe abortion services. Multiple approaches should be used when attempting to improve knowledge and perceptions about stigmatized health issues such as abortion.

  3. Association between recent sports activity, sports activity in young adulthood, and stroke.

    PubMed

    Grau, Armin J; Barth, Cordula; Geletneky, Beate; Ling, Paul; Palm, Frederik; Lichy, Christoph; Becher, Heiko; Buggle, Florian

    2009-02-01

    Leisure-time physical activity protects from stroke. It is insufficiently established whether early lifetime physical activity is independently protective and whether some etiologic stroke subgroups particularly benefit from physical activity. We tested the hypothesis that both recent and early-adulthood sports activities are associated with reduced odds of stroke and analyzed their effects in stroke subtypes. We performed a case-control study of 370 patients with acute stroke or transient ischemic attack (TIA) and 370 age- and sex-matched control subjects randomly selected from the population and assessed recent and young adulthood sports activities and their weekly duration in standardized interviews. Recent regular sports activities were less often reported by patients (94/370, 25.4%) than by control subjects (162/370, 43.8%; P<0.0001). After adjustment for vascular risk factors, education, and other factors, recent participation in sports was significantly associated with reduced odds of stroke/TIA (odds ratio=0.64; 95% CI, 0.43 to 0.96). Both groups did not differ with regard to sports activities in young adulthood. More control subjects (69/365, 18.9%) than patients (25/361, 6.9%) participated in sports recently after not having been active in young adulthood, and such a pattern was associated with reduced odds of stroke/TIA in multivariable analysis (odds ratio=0.37; 95% CI, 0.21 to 0.85). Our study supports previous results that have shown stroke protection by physical activity. Results suggest that continuous lifetime activity or starting activities during later adulthood is required to reduce stroke risk.

  4. Is frequency of shared family meals related to the nutritional health of children and adolescents?

    PubMed

    Hammons, Amber J; Fiese, Barbara H

    2011-06-01

    We used meta-analytic methods to examine the frequency of shared family mealtimes in relation to nutritional health in children and adolescents. The primary objective was to determine consistency and strength of effects across 17 studies that examined overweight and obese, food consumption and eating patterns, and disordered eating. The total sample size for all studies was 182 836 children and adolescents (mean sample age: 2.8-17.3 years). Pooled odds ratios were calculated. A random-effects model was used to estimate all outcomes. The frequency of shared family meals is significantly related to nutritional health in children and adolescents. Children and adolescents who share family meals 3 or more times per week are more likely to be in a normal weight range and have healthier dietary and eating patterns than those who share fewer than 3 family meals together. In addition, they are less likely to engage in disordered eating. Educational and public health initiatives aimed at promoting shared family mealtimes may improve nutritional health of children and adolescents. Clinicians may advise their patients about the benefits of sharing 3 or more family mealtimes per week; benefits include a reduction in the odds for overweight (12%), eating unhealthy foods (20%), and disordered eating (35%) and an increase in the odds for eating healthy foods (24%).

  5. Is Frequency of Shared Family Meals Related to the Nutritional Health of Children and Adolescents?

    PubMed Central

    Fiese, Barbara H.

    2011-01-01

    OBJECTIVE: We used meta-analytic methods to examine the frequency of shared family mealtimes in relation to nutritional health in children and adolescents. The primary objective was to determine consistency and strength of effects across 17 studies that examined overweight and obese, food consumption and eating patterns, and disordered eating. METHODS: The total sample size for all studies was 182 836 children and adolescents (mean sample age: 2.8–17.3 years). Pooled odds ratios were calculated. A random-effects model was used to estimate all outcomes. RESULTS: The frequency of shared family meals is significantly related to nutritional health in children and adolescents. Children and adolescents who share family meals 3 or more times per week are more likely to be in a normal weight range and have healthier dietary and eating patterns than those who share fewer than 3 family meals together. In addition, they are less likely to engage in disordered eating. CONCLUSIONS: Educational and public health initiatives aimed at promoting shared family mealtimes may improve nutritional health of children and adolescents. Clinicians may advise their patients about the benefits of sharing 3 or more family mealtimes per week; benefits include a reduction in the odds for overweight (12%), eating unhealthy foods (20%), and disordered eating (35%) and an increase in the odds for eating healthy foods (24%). PMID:21536618

  6. Effectiveness of family group conferencing in preventing repeat referrals to child protective services and out-of-home placements.

    PubMed

    Hollinshead, Dana M; Corwin, Tyler W; Maher, Erin J; Merkel-Holguin, Lisa; Allan, Heather; Fluke, John D

    2017-07-01

    Rigorous research on the efficacy of family group conferencing is rare. This randomized control trial study used an intent-to-treat approach to examine whether a referral to a family group conference (FGC) was associated with re-referrals, substantiated re-referrals, or out-of-home placements among child welfare-involved families receiving in-home services. We found no significant associations between treatment and control group assignment and the three outcomes for the sample as a whole. However, families with more children had higher odds of a re-referral and a substantiated re-referral, families with more than one parent had higher odds of re-referral, and families where a substance abuse services referral was noted had higher odds of out-of-home placement. In interaction models with race, we found that families with African American mothers who were referred for an FGC were more likely to be re-referred compared to other families, but no differences were identified with respect to their rates of substantiated re-referrals or out-of-home placements. Implications are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Inguinal and subinguinal micro-varicocelectomy, the optimal surgical management of varicocele: a meta-analysis

    PubMed Central

    Wang, Jun; Xia, Shu-Jie; Liu, Zhi-Hong; Tao, Le; Ge, Ji-Fu; Xu, Chen-Min; Qiu, Jian-Xin

    2015-01-01

    Conventional meta-analyses have shown inconsistent results for the efficacy of various treatments of varicoceles. Therefore, we performed a multiple-treatment meta-analysis to assess the effectiveness and safety of 10 methods of varicocelectomy and embolization/sclerotherapy. We systematically reviewed 35 randomized controlled trials and observational studies, from 1966 to August 5, 2013, which compared any of the following treatments for varococeles: laparoscopic, retroperitoneal, open inguinal and subinguinal varicocelectomy, microsurgical subinguinal and inguinal varicocelectomy, percutaneous venous embolization, Tauber antegrade sclerotherapy, retrograde sclerotherapy and expectant therapy (no treatment). Inguinal and subinguinal microsurgery, open inguinal, laparoscopic varicocelectomy showed a significant advantage over expectant therapy in terms of pregnancy rates (odds ratio (OR): 3.48, 2.68, 2.92 and 2.90, respectively). Compared with retroperitoneal open surgery, inguinal microsurgery showed an improvement of sperm density (mean difference (MD): 10.60, 95% confidence interval (CI): 1.92–19.60) and sperm motility (MD: 9.09, 95% CI: 4.88–13.30). Subinguinal and inguinal microsurgery outperformed retroperitoneal open surgery in terms of recurrence (OR: 0.05, 0.06 respectively). Tauber antegrade sclerotherapy and subinguinal microsurgery were associated with the lowest risk of hydrocele formation. The odds of overall complication, compared with retroperitoneal open varicocelectomy, were lowest for inguinal microsurgery (OR = 0.07, 95% CI: 0.02–0.19), followed by subinguinal microsurgery (OR = 0.09, 95% CI: 0.02–0.19). Inguinal and subinguinal micro-varicocelectomy had the highest pregnancy rates, significant increases in sperm parameters, with low odds of complication. These results warrant additional properly conducted randomized controlled clinical studies with larger sample sizes. PMID:25248652

  8. Maternal Obesity in Pregnancy, Gestational Weight Gain, and Risk of Childhood Asthma

    PubMed Central

    Young, Omar M.; Kumar, Rajesh; Simhan, Hyagriv; Celedón, Juan C.

    2014-01-01

    BACKGROUND AND OBJECTIVE: Environmental or lifestyle exposures in utero may influence the development of childhood asthma. In this meta-analysis, we aimed to assess whether maternal obesity in pregnancy (MOP) or increased maternal gestational weight gain (GWG) increased the risk of asthma in offspring. METHODS: We included all observational studies published until October 2013 in PubMed, Embase, CINAHL, Scopus, The Cochrane Database, and Ovid. Random effects models with inverse variance weights were used to calculate pooled risk estimates. RESULTS: Fourteen studies were included (N = 108 321 mother–child pairs). Twelve studies reported maternal obesity, and 5 reported GWG. Age of children was 14 months to 16 years. MOP was associated with higher odds of asthma or wheeze ever (OR = 1.31; 95% confidence interval [CI], 1.16–1.49) or current (OR = 1.21; 95% CI, 1.07–1.37); each 1-kg/m2 increase in maternal BMI was associated with a 2% to 3% increase in the odds of childhood asthma. High GWG was associated with higher odds of asthma or wheeze ever (OR = 1.16; 95% CI, 1.001–1.34). Maternal underweight and low GWG were not associated with childhood asthma or wheeze. Meta-regression showed a negative association of borderline significance for maternal asthma history (P = .07). The significant heterogeneity among existing studies indicates a need for standardized approaches to future studies on the topic. CONCLUSIONS: MOP and high GWG are associated with an elevated risk of childhood asthma; this finding may be particularly significant for mothers without asthma history. Prospective randomized trials of maternal weight management are needed. PMID:25049351

  9. Demographic and Prescribing Patterns of Chinese Herbal Products for Individualized Therapy for Ischemic Heart Disease in Taiwan: Population-Based Study

    PubMed Central

    Hu, Wen-Long; Chen, Hsuan-Ju; Li, Tsai-Chung; Tsai, Pei-Yuan; Chen, Hsin-Ping; Huang, Meng-Hsuan; Su, Fang-Yen

    2015-01-01

    Objective Combinations of Chinese herbal products (CHPs) are widely used for ischemic heart disease (IHD) in Taiwan. We analyzed the usage and frequency of CHPs prescribed for patients with IHD. Methods A nationwide population-based cross-sectional study was conducted, 53531 patients from a random sample of one million in the National Health Insurance Research Database (NHIRD) from 2000 to 2010 were enrolled. Descriptive statistics, the multiple logistic regression method and Poisson regression analysis were employed to estimate the adjusted odds ratios (aORs) and adjusted risk ratios (aRRs) for utilization of CHPs. Results The mean age of traditional Chinese medicine (TCM) nonusers was significantly higher than that of TCM users. Zhi-Gan-Cao-Tang (24.85%) was the most commonly prescribed formula CHPs, followed by Xue-Fu-Zhu-Yu-Tang (16.53%) and Sheng-Mai-San (16.00%). The most commonly prescribed single CHPs were Dan Shen (29.30%), Yu Jin (7.44%), and Ge Gen (6.03%). After multivariate adjustment, patients with IHD younger than 29 years had 2.62 times higher odds to use TCM than those 60 years or older. Residents living in Central Taiwan, having hyperlipidemia or cardiac dysrhythmias also have higher odds to use TCM. On the contrary, those who were males, who had diabetes mellitus (DM), hypertension, stroke, myocardial infarction (MI) were less likely to use TCM. Conclusions Zhi-Gan-Cao-Tang and Dan Shen are the most commonly prescribed CHPs for IHD in Taiwan. Our results should be taken into account by physicians when devising individualized therapy for IHD. Further large-scale, randomized clinical trials are warranted in order to determine the effectiveness and safety of these herbal medicines. PMID:26322893

  10. Multidimensional team-based intervention using musical cues to reduce odds of facility-acquired pressure ulcers in long-term care: a paired randomized intervention study.

    PubMed

    Yap, Tracey L; Kennerly, Susan M; Simmons, Mark R; Buncher, Charles R; Miller, Elaine; Kim, Jay; Yap, Winston Y

    2013-09-01

    To test the effectiveness of a pressure ulcer (PU) prevention intervention featuring musical cues to remind all long-term care (LTC) staff (nursing and ancillary) to help every resident move or reposition every 2 hours. Twelve-month paired-facility two-arm (with one-arm crossover) randomized intervention trial. Ten midwestern U.S. LTC facilities. Four treatment facilities received intervention during Months 1 to 12, four comparison facilities received intervention during Months 7 to 12, and two pseudo-control facilities received no intervention. LTC facility residents (N = 1,928). All facility staff received in-person education, video, and handouts, and visiting family members received informational pamphlets on PU prevention and an intervention featuring musical cues. Nurse-led multidisciplinary staff teams presented the cues as prompts for staff and family to reposition residents or remind them to move. Musical selections (with and without lyrics) customized to facility preferences were played daily over the facility intercom or public address system every 2 hours for the 12-hour daytime period. Primary outcome measure was the frequency of new facility-acquired PUs divided by the total number of facility Minimum Data Set (MDS) resident assessments conducted during the study period. Odds of a new PU were lower in intervention facilities (P = .08) for MDS 2.0 assessments and were significantly lower (P = .05) for MDS 3.0. Mean odds ratios suggested intervention facility residents were 45% less likely than comparison facility residents to develop a new PU. Customized musical cues that prompt multidisciplinary staff teams to encourage or enable movement of all residents hold promise for reducing facility-acquired PUs in LTC settings. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

  11. Maternal obesity in pregnancy, gestational weight gain, and risk of childhood asthma.

    PubMed

    Forno, Erick; Young, Omar M; Kumar, Rajesh; Simhan, Hyagriv; Celedón, Juan C

    2014-08-01

    Environmental or lifestyle exposures in utero may influence the development of childhood asthma. In this meta-analysis, we aimed to assess whether maternal obesity in pregnancy (MOP) or increased maternal gestational weight gain (GWG) increased the risk of asthma in offspring. We included all observational studies published until October 2013 in PubMed, Embase, CINAHL, Scopus, The Cochrane Database, and Ovid. Random effects models with inverse variance weights were used to calculate pooled risk estimates. Fourteen studies were included (N = 108 321 mother-child pairs). Twelve studies reported maternal obesity, and 5 reported GWG. Age of children was 14 months to 16 years. MOP was associated with higher odds of asthma or wheeze ever (OR = 1.31; 95% confidence interval [CI], 1.16-1.49) or current (OR = 1.21; 95% CI, 1.07-1.37); each 1-kg/m(2) increase in maternal BMI was associated with a 2% to 3% increase in the odds of childhood asthma. High GWG was associated with higher odds of asthma or wheeze ever (OR = 1.16; 95% CI, 1.001-1.34). Maternal underweight and low GWG were not associated with childhood asthma or wheeze. Meta-regression showed a negative association of borderline significance for maternal asthma history (P = .07). The significant heterogeneity among existing studies indicates a need for standardized approaches to future studies on the topic. MOP and high GWG are associated with an elevated risk of childhood asthma; this finding may be particularly significant for mothers without asthma history. Prospective randomized trials of maternal weight management are needed. Copyright © 2014 by the American Academy of Pediatrics.

  12. Cluster Randomized Test-Negative Design (CR-TND) Trials: A Novel and Efficient Method to Assess the Efficacy of Community Level Dengue Interventions.

    PubMed

    Anders, Katherine L; Cutcher, Zoe; Kleinschmidt, Immo; Donnelly, Christl A; Ferguson, Neil M; Indriani, Citra; O'Neill, Scott L; Jewell, Nicholas P; Simmons, Cameron P

    2018-05-07

    Cluster randomized trials are the gold standard for assessing efficacy of community-level interventions, such as vector control strategies against dengue. We describe a novel cluster randomized trial methodology with a test-negative design, which offers advantages over traditional approaches. It utilizes outcome-based sampling of patients presenting with a syndrome consistent with the disease of interest, who are subsequently classified as test-positive cases or test-negative controls on the basis of diagnostic testing. We use simulations of a cluster trial to demonstrate validity of efficacy estimates under the test-negative approach. This demonstrates that, provided study arms are balanced for both test-negative and test-positive illness at baseline and that other test-negative design assumptions are met, the efficacy estimates closely match true efficacy. We also briefly discuss analytical considerations for an odds ratio-based effect estimate arising from clustered data, and outline potential approaches to analysis. We conclude that application of the test-negative design to certain cluster randomized trials could increase their efficiency and ease of implementation.

  13. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial.

    PubMed

    Weiniger, Carolyn F; Ginosar, Yehuda; Elchalal, Uriel; Sharon, Einav; Nokrian, Malka; Ezra, Yossef

    2007-12-01

    To compare the success of external cephalic version using spinal analgesia with no analgesia among nulliparas. A prospective randomized controlled trial was performed in a tertiary referral center delivery suite. Nulliparous women at term requesting external cephalic version for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia before the external cephalic version. An experienced obstetrician performed the external cephalic version. Primary outcome was successful conversion to vertex presentation. Seventy-four women were enrolled, and 70 analyzed (36 spinal, 34 no analgesia). Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 (95% confidence interval [CI] of the difference: 0.0954-0.5513). External cephalic version with spinal analgesia resulted in a lower visual analog pain score, 1.76+/-2.74 compared with 6.84+/-3.08 without, P<.001. A secondary analysis logistic regression model demonstrated that the odds of external cephalic version success was 4.0-fold higher when performed with spinal analgesia P=.02 (95% CI, odds ratio [OR] 1.2-12.9). Complete breech presentation before attempting external cephalic version increased the odds of success 8.2-fold, P=.001 (95% CI, OR 2.2-30.3). Placental position, estimated fetal weight, and maternal weight did not contribute to the success rate when spinal analgesia was used. There were no cases of placental abruption or fetal distress. Administration of spinal analgesia significantly increases the success rate of external cephalic version among nulliparous women at term, which allows possible normal vaginal delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00119184 I.

  14. Educational interventions to improve screening mammography interpretation: a randomized, controlled trial

    PubMed Central

    BM, Geller; A, Bogart; PA, Carney; EA, Sickles; RA, Smith; B, Monsees; LW, Bassett; DM, Buist; K, Kerlikowske; T, Onega; B, Yankaskas; S, Haneuse; DA, Hill; M, Wallis; DL, Miglioretti

    2014-01-01

    Purpose Conduct a randomized controlled trial of educational interventions to improve performance of screening mammography interpretation. Materials and Methods We randomly assigned physicians who interpret mammography to one of three groups: (1) self-paced DVD; (2) live, expert-led educational session; or (3) control. The DVD and live interventions used mammography cases of varying difficulty and associated teaching points. Interpretive performance was compared using a pre-/post-test design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall, and each were compared using logistic regression adjusting for pre-test performance. Results 102 radiologists completed all aspects of the trial. After adjustment for pre-intervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than controls (95% confidence interval [CI]: 1.00, 1.81; P=0.050). The odds of improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR]=1.94, 95% CI: 1.24, 3.05; P=0.004) and cancer status (OR=1.81, 95% CI: 1.01, 3.23; P=0.045) were significantly improved for DVD participants compared to controls with no significant change in specificity. For the live-intervention group, specificity was significantly lower than the control group (OR relative to expert recall=0.80; 95% CI: 0.64, 1.00; P=0.048; OR relative to cancer=0.79; 95% CI: 0.65, 0.95; P=0.015). Conclusion In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in mammography interpretive screening performance on a test-set, which could translate into improved clinical interpretative performance. PMID:24848854

  15. Educational interventions to improve screening mammography interpretation: a randomized controlled trial.

    PubMed

    Geller, Berta M; Bogart, Andy; Carney, Patricia A; Sickles, Edward A; Smith, Robert; Monsees, Barbara; Bassett, Lawrence W; Buist, Diana M; Kerlikowske, Karla; Onega, Tracy; Yankaskas, Bonnie C; Haneuse, Sebastien; Hill, Deirdre; Wallis, Matthew G; Miglioretti, Diana

    2014-06-01

    The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation. We randomly assigned physicians who interpret mammography to one of three groups: self-paced DVD, live expert-led educational seminar, or control. The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points. Interpretive performance was compared using a pretest-posttest design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall. The performance measures for each group were compared using logistic regression adjusting for pretest performance. One hundred two radiologists completed all aspects of the trial. After adjustment for preintervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects (95% CI, 1.00-1.81; p = 0.050). The odds of an improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR] = 1.94; 95% CI, 1.24-3.05; p = 0.004) and cancer status (OR = 1.81; 95% CI, 1.01-3.23; p = 0.045) were significantly improved for DVD participants compared with control subjects, with no significant change in specificity. For the seminar group, specificity was significantly lower than the control group (OR relative to expert recall = 0.80; 95% CI, 0.64-1.00; p = 0.048; OR relative to cancer status = 0.79; 95% CI, 0.65-0.95; p = 0.015). In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set, which could translate into improved interpretative performance in clinical practice.

  16. The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis.

    PubMed

    Etter, Jean-François; Burri, Mafalda; Stapleton, John

    2007-05-01

    To assess whether source of funding affected the results of trials of nicotine replacement therapy (NRT) for smoking cessation. We reviewed all randomized controlled trials included in the Cochrane review. There were insufficient non-industry trials of the newer products for these to be included. We included 90 trials of either the nicotine gum (52) or nicotine patch (38). They comprised 18 238 treatment and 16 235 control participants. Forty-nine showed evidence of industry support (18 gum, 31 patch). Industry (31 of 49, 63%) compared with non-industry (seven of 41, 17%, P < 0.001) supported a higher proportion of nicotine patch studies and had larger sample sizes (479 versus 268, P = 0.04). Twenty-five (51%) industry trials reported statistically significant (P < 0.05) results, compared with nine (22%) non-industry trials (OR = 3.70, 95% CI = 1.46-9.35). This difference was not explained by trial characteristics. Industry-supported trials had a pooled odds ratio of 1.90 (1.67-2.16), compared with 1.61 (1.43-1.80) for other studies (chi(2) = 3.6, P = 0.058). There was evidence of funnel-plot asymmetry among industry trials (t = 4.35, P < 0.001), but not among other trials, indicating that several small null-effect industry trials may not have reached publication. After imputation adjustment, the odds ratio for industry trials reduced to 1.64 (1.43-1.89) and the overall NRT odds ratio reduced from 1.73 (1.60-1.90) to 1.62 (1.49-1.77). Compared with independent trials, industry-supported trials were more likely to produce statistically significant results and larger odds ratios. These differences persisted after adjustment for basic trial characteristics. Although we had no data on the amount of funding for each trial, it is possible that more resources led to higher treatment compliance and therefore greater efficacy in industry-supported trials. Differences can also possibly be explained by publication bias with several small, null-effect industry studies not having reached publication. After adjustment for this possible bias, results for industry trials were lower and similar to non-industry results. Similarly, the overall estimate of the net effect for these products reduces to about 5% attributable 1-year successes. This remains of considerable public health benefit. Registration of clinical trials has become mandatory in many countries since most of the trials considered here were conducted, and this should reduce the potential for publication bias in future.

  17. Examination of the association between announced inspections and inspection scores.

    PubMed

    Waters, A Blake; VanDerslice, James; Porucznik, Christina A; Kim, Jaewhan; DeLegge, Royal; Durrant, Lynne

    2013-09-01

    In 2010 the Salt Lake Valley Health Department conducted a pilot of an announced inspection program utilizing a randomized assignment of restaurants to an intervention group with announced inspections and a control group that remained on the usual schedule of unannounced inspections. After adjusting for food type, visible kitchen, outside quality assurance, season, and standardized inspector, significant reductions were found in the odds ratios of personal hygiene (adjusted odds ratios [aOR] = 0.11, p = .00) and equipment cleanliness (aOR = 0.19, p = .00) violations. In the models for the control group, none of the odds ratios were statistically different from one, indicating no change in the postintervention time period as compared to the preintervention period.

  18. The odd-even effect in Sudoku puzzles: effects of working memory, aging, and experience.

    PubMed

    Chang, Hye-Sang; Gibson, Janet M

    2011-01-01

    The odd-even effect in numerical processing has been explained as the easier processing of even numbers compared with odd numbers. We investigated this effect in Sudoku puzzles, a reasoning problem that uses numbers but does not require arithmetic operations. Specifically, we asked whether the odd-even effect occurred with Sudoku puzzles and whether individual differences in working memory (WM), aging, and experience with Sudoku modulated this effect. We manipulated the presence of odd and even numbers in Sudoku puzzles, measured WM with the Wisconsin Card Sorting Test and backward digit span task, tested older and younger adults, and collected Sudoku experience frequency. Performance on Sudoku was more accurate for even puzzles than odd ones. Younger, experienced, and higher-WM participants were more accurate on Sudoku, but these individual difference variables did not interact with the odd-even effect. Odd numbers may impose more cognitive load than even numbers, but future research is needed to examine how age, experience, or WM may influence the odd-even effect.

  19. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial.

    PubMed

    Puente, Diana; Cabezas, Carmen; Rodriguez-Blanco, Teresa; Fernández-Alonso, Carmen; Cebrian, Tránsito; Torrecilla, Miguel; Clemente, Lourdes; Martín, Carlos

    2011-05-23

    The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. CLINICALTRIALS.GOV IDENTIFIER: NCT00125905.

  20. Relative Age Effects Across and Within Female Sport Contexts: A Systematic Review and Meta-Analysis.

    PubMed

    Smith, Kristy L; Weir, Patricia L; Till, Kevin; Romann, Michael; Cobley, Stephen

    2018-06-01

    Subtle differences in chronological age within sport (bi-) annual-age groupings can contribute to immediate participation and long-term attainment discrepancies; known as the relative age effect. Voluminous studies have examined relative age effects in male sport; however, their prevalence and context-specific magnitude in female sport remain undetermined. The objective of this study was to determine the prevalence and magnitude of relative age effects in female sport via examination of published data spanning 1984-2016. Registered with PROSPERO (No. 42016053497) and using Preferred Reporting Items for Systematic Reviews and Meta-analysis systematic search guidelines, 57 studies were identified, containing 308 independent samples across 25 sports. Distribution data were synthesised using odds ratio meta-analyses, applying an invariance random-effects model. Follow-up subgroup category analyses examined whether relative age effect magnitudes were moderated by age group, competition level, sport type, sport context and study quality. When comparing the relatively oldest (quartile 1) vs. youngest (quartile 4) individuals across all female sport contexts, the overall pooled estimate identified a significant but small relative age effect (odds ratio = 1.25; 95% confidence interval 1.21-1.30; p = 0.01; odds ratio adjusted = 1.21). Subgroup analyses revealed the relative age effect magnitude was higher in pre-adolescent (≤ 11 years) and adolescent (12-14 years) age groups and at higher competition levels. Relative age effect magnitudes were higher in team-based and individual sport contexts associated with high physiological demands. The findings highlight relative age effects are prevalent across the female sport contexts examined. Relative age effect magnitude is moderated by interactions between developmental stages, competition level and sport context demands. Modifications to sport policy, organisational and athlete development system structure, as well as practitioner intervention are recommended to prevent relative age effect-related participation and longer term attainment inequalities.

  1. Prognostic Value of Myocardial Scarring on CMR in Patients With Cardiac Sarcoidosis.

    PubMed

    Coleman, G Cameron; Shaw, Peter W; Balfour, Pelbreton C; Gonzalez, Jorge A; Kramer, Christopher M; Patel, Amit R; Salerno, Michael

    2017-04-01

    This study sought to perform a systematic review and meta-analysis to understand the prognostic value of myocardial scarring as evidenced by late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging in patients with known or suspected cardiac sarcoidosis. Although CMR is increasingly used for the diagnosis of cardiac sarcoidosis, the prognostic value of CMR has been less well described in this population. PubMed, Cochrane CENTRAL, and metaRegister of Controlled Trials were searched for CMR studies with ≥1 year of prognostic data. Primary endpoints were all-cause mortality and a composite outcome of arrhythmogenic events (ventricular arrhythmia, implantable cardioverter-defibrillator shock, sudden cardiac death) plus all-cause mortality during follow-up. Summary effect estimates were generated with random-effects modeling. Ten studies were included, involving a total of 760 patients with a mean follow-up of 3.0 ± 1.1 years. Patients had a mean age of 53 years, 41% were male, 95.3% had known extracardiac sarcoidosis, and 21.6% had known cardiac sarcoidosis. The average ejection fraction was 57.8 ± 9.1%. Patients with LGE had higher odds for all-cause mortality (odds ratio [OR]: 3.06; p < 0.03) and higher odds of the composite outcome (OR: 10.74; p < 0.00001) than those without LGE. Patients with LGE had an increased annualized event rate of the composite outcome (11.9% vs. 1.1%; p < 0.0001). In patients with known or suspected cardiac sarcoidosis, the presence of LGE on CMR imaging is associated with increased odds of both all-cause mortality and arrhythmogenic events. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Effect of Right Insular Involvement on Death and Functional Outcome After Acute Ischemic Stroke in the IST-3 Trial (Third International Stroke Trial).

    PubMed

    Sposato, Luciano A; Cohen, Geoffrey; Wardlaw, Joanna M; Sandercock, Peter; Lindley, Richard I; Hachinski, Vladimir

    2016-12-01

    In patients with acute ischemic stroke, whether involvement of the insular cortex influences outcome is controversial. Much of the apparent adverse outcome may relate to such strokes usually being severe. We examined the influence of right and left insular involvement on stroke outcomes among patients from the IST-3 study (Third International Stroke Trial) who had visible ischemic stroke on neuroimaging. We used multiple logistic regression to compare outcomes of left versus right insular and noninsular strokes across strata of stroke severity, on death, proportion dead or dependent, and level of disability (ordinalized Oxford Handicap Score) at 6 months, with adjustment for the effects of age, lesion size, and presence of atrial fibrillation. Of 3035 patients recruited, 2099 had visible ischemic strokes limited to a single hemisphere on computed tomography/magnetic resonance scans. Of these, 566 and 714 had infarction of right and left insula. Six months after randomization, right insular involvement was associated with increased odds of death when compared with noninsular strokes on the left side (adjusted odds ratio, 1.83; 95% confidence interval, 1.33-2.52), whereas the adjusted odds ratio comparing mortality after insular versus noninsular strokes on the left side was not significant. Among mild/moderate strokes, outcomes for right insular involvement were worse than for left insular, but among more severe strokes, the difference in outcomes was less substantial. We found an association between right insular involvement and higher odds of death and worse functional outcome. The difference between right- and left-sided insular lesions on outcomes seemed to be most evident for mild/moderate strokes. URL: http://www.isrctn.com. Unique identifier: ISRCTN25765518. © 2016 American Heart Association, Inc.

  3. Risk factors for intracranial hemorrhage in acute ischemic stroke patients treated with recombinant tissue plasminogen activator: a systematic review and meta-analysis of 55 studies.

    PubMed

    Whiteley, William N; Slot, Karsten Bruins; Fernandes, Peter; Sandercock, Peter; Wardlaw, Joanna

    2012-11-01

    Recombinant tissue plasminogen activator (rtPA) is an effective treatment for acute ischemic stroke but is associated with an increased risk of intracranial hemorrhage (ICH). We sought to identify the risk factors for ICH with a systematic review of the published literature. We searched for studies of rtPA-treated stroke patients that reported an association between a variable measured before rtPA infusion and clinically important ICH (parenchymal ICH or ICH associated with clinical deterioration). We calculated associations between baseline variables and ICH with random-effect meta-analyses. We identified 55 studies that measured 43 baseline variables in 65 264 acute ischemic stroke patients. Post-rtPA ICH was associated with higher age (odds ratio, 1.03 per year; 95% confidence interval, 1.01-1.04), higher stroke severity (odds ratio, 1.08 per National Institutes of Health Stroke Scale point; 95% confidence interval, 1.06-1.11), and higher glucose (odds ratio, 1.10 per mmol/L; 95% confidence interval, 1.05-1.14). There was approximately a doubling of the odds of ICH with the presence of atrial fibrillation, congestive heart failure, renal impairment, previous antiplatelet agents, leukoaraiosis, and a visible acute cerebral ischemic lesion on pretreatment brain imaging. Little of the variation in the sizes of the associations among different studies was explained by the source of the cohort, definition of ICH, or degree of adjustment for confounding variables. Individual baseline variables were modestly associated with post-rtPA ICH. Prediction of post-rtPA ICH therefore is likely to be difficult if based on single clinical or imaging factors alone. These observational data do not provide a reliable method for the individualization of treatment according to predicted ICH risk.

  4. The Relationship of Bilingualism Compared to Monolingualism to the Risk of Cognitive Decline or Dementia: A Systematic Review and Meta-Analysis.

    PubMed

    Mukadam, Naaheed; Sommerlad, Andrew; Livingston, Gill

    2017-01-01

    Bilingualism may contribute to cognitive reserve, protect against cognitive decline, and delay the onset of dementia. We systematically reviewed evidence about the effect of bilingualism on subsequent cognitive decline or dementia. We searched electronic databases and references for longitudinal studies comparing cognitive decline in people who were bilingual with those who were monolingual and evaluated study quality. We conducted meta-analyses using random effects models to calculate pooled odds ratio of incident dementia. We included 13/1,156 eligible articles. Meta-analysis of prospective studies of the effects of bilingualism on future dementia gave a combined Odds Ratio of dementia of 0.96 (95% CI 0.74-1.23) in bilingual participants (n = 5,527) compared to monolinguals. Most retrospective studies found that bilingual people were reported to develop symptoms of cognitive decline at a later age than monolingual participants. We did not find that bilingualism protects from cognitive decline or dementia from prospective studies. Retrospective studies are more prone to confounding by education, or cultural differences in presentation to dementia services and are therefore not suited to establishing causative links between risk factors and outcomes.

  5. Socioeconomic Status Accounts for Rapidly Increasing Geographic Variation in the Incidence of Poor Fetal Growth

    PubMed Central

    Ball, Stephen J.; Jacoby, Peter; Zubrick, Stephen R.

    2013-01-01

    Fetal growth is an important risk factor for infant morbidity and mortality. In turn, socioeconomic status is a key predictor of fetal growth; however, other sociodemographic factors and environmental effects may also be important. This study modelled geographic variation in poor fetal growth after accounting for socioeconomic status, with a fixed effect for socioeconomic status and a combination of spatially-correlated and spatially-uncorrelated random effects. The dataset comprised 88,246 liveborn singletons, aggregated within suburbs in Perth, Western Australia. Low socioeconomic status was strongly associated with an increased risk of poor fetal growth. An increase in geographic variation of poor fetal growth from 1999–2001 (interquartile odds ratio among suburbs = 1.20) to 2004–2006 (interquartile odds ratio = 1.40) indicated a widening risk disparity by socioeconomic status. Low levels of residual spatial patterns strengthen the case for targeting policies and practices in areas of low socioeconomic status for improved outcomes. This study indicates an alarming increase in geographic inequalities in poor fetal growth in Perth which warrants further research into the specific aspects of socioeconomic status that act as risk factors. PMID:23799513

  6. Physical Activity Attenuates the Influence of FTO Variants on Obesity Risk: A Meta-Analysis of 218,166 Adults and 19,268 Children

    PubMed Central

    Kilpeläinen, Tuomas O.; Qi, Lu; Brage, Soren; Sharp, Stephen J.; Sonestedt, Emily; Demerath, Ellen; Ahmad, Tariq; Mora, Samia; Kaakinen, Marika; Sandholt, Camilla Helene; Holzapfel, Christina; Autenrieth, Christine S.; Hyppönen, Elina; Cauchi, Stéphane; He, Meian; Kutalik, Zoltan; Kumari, Meena; Stančáková, Alena; Meidtner, Karina; Balkau, Beverley; Tan, Jonathan T.; Mangino, Massimo; Timpson, Nicholas J.; Song, Yiqing; Zillikens, M. Carola; Jablonski, Kathleen A.; Garcia, Melissa E.; Johansson, Stefan; Bragg-Gresham, Jennifer L.; Wu, Ying; van Vliet-Ostaptchouk, Jana V.; Onland-Moret, N. Charlotte; Zimmermann, Esther; Rivera, Natalia V.; Tanaka, Toshiko; Stringham, Heather M.; Silbernagel, Günther; Kanoni, Stavroula; Feitosa, Mary F.; Snitker, Soren; Ruiz, Jonatan R.; Metter, Jeffery; Larrad, Maria Teresa Martinez; Atalay, Mustafa; Hakanen, Maarit; Amin, Najaf; Cavalcanti-Proença, Christine; Grøntved, Anders; Hallmans, Göran; Jansson, John-Olov; Kuusisto, Johanna; Kähönen, Mika; Lutsey, Pamela L.; Nolan, John J.; Palla, Luigi; Pedersen, Oluf; Pérusse, Louis; Renström, Frida; Scott, Robert A.; Shungin, Dmitry; Sovio, Ulla; Tammelin, Tuija H.; Rönnemaa, Tapani; Lakka, Timo A.; Uusitupa, Matti; Rios, Manuel Serrano; Ferrucci, Luigi; Bouchard, Claude; Meirhaeghe, Aline; Fu, Mao; Walker, Mark; Borecki, Ingrid B.; Dedoussis, George V.; Fritsche, Andreas; Ohlsson, Claes; Boehnke, Michael; Bandinelli, Stefania; van Duijn, Cornelia M.; Ebrahim, Shah; Lawlor, Debbie A.; Gudnason, Vilmundur; Harris, Tamara B.; Sørensen, Thorkild I. A.; Mohlke, Karen L.; Hofman, Albert; Uitterlinden, André G.; Tuomilehto, Jaakko; Lehtimäki, Terho; Raitakari, Olli; Isomaa, Bo; Njølstad, Pål R.; Florez, Jose C.; Liu, Simin; Ness, Andy; Spector, Timothy D.; Tai, E. Shyong; Froguel, Philippe; Boeing, Heiner; Laakso, Markku; Marmot, Michael; Bergmann, Sven; Power, Chris; Khaw, Kay-Tee; Chasman, Daniel; Ridker, Paul; Hansen, Torben; Monda, Keri L.; Illig, Thomas; Järvelin, Marjo-Riitta; Wareham, Nicholas J.; Hu, Frank B.; Groop, Leif C.; Orho-Melander, Marju; Ekelund, Ulf; Franks, Paul W.; Loos, Ruth J. F.

    2011-01-01

    Background The FTO gene harbors the strongest known susceptibility locus for obesity. While many individual studies have suggested that physical activity (PA) may attenuate the effect of FTO on obesity risk, other studies have not been able to confirm this interaction. To confirm or refute unambiguously whether PA attenuates the association of FTO with obesity risk, we meta-analyzed data from 45 studies of adults (n = 218,166) and nine studies of children and adolescents (n = 19,268). Methods and Findings All studies identified to have data on the FTO rs9939609 variant (or any proxy [r 2>0.8]) and PA were invited to participate, regardless of ethnicity or age of the participants. PA was standardized by categorizing it into a dichotomous variable (physically inactive versus active) in each study. Overall, 25% of adults and 13% of children were categorized as inactive. Interaction analyses were performed within each study by including the FTO×PA interaction term in an additive model, adjusting for age and sex. Subsequently, random effects meta-analysis was used to pool the interaction terms. In adults, the minor (A−) allele of rs9939609 increased the odds of obesity by 1.23-fold/allele (95% CI 1.20–1.26), but PA attenuated this effect (p interaction  = 0.001). More specifically, the minor allele of rs9939609 increased the odds of obesity less in the physically active group (odds ratio  = 1.22/allele, 95% CI 1.19–1.25) than in the inactive group (odds ratio  = 1.30/allele, 95% CI 1.24–1.36). No such interaction was found in children and adolescents. Conclusions The association of the FTO risk allele with the odds of obesity is attenuated by 27% in physically active adults, highlighting the importance of PA in particular in those genetically predisposed to obesity. Please see later in the article for the Editors' Summary PMID:22069379

  7. Long term unemployment, income, poverty, and social public expenditure, and their relationship with self-perceived health in Spain (2007-2011).

    PubMed

    López Del Amo González, M Puerto; Benítez, Vivian; Martín-Martín, José J

    2018-01-15

    There is scant research that simultaneously analyzes the joint effects of long-term unemployment, poverty and public expenditure policies on poorer self-perceived health during the financial crisis. The aim of the study is to analyze the joint relationship between long-term unemployment, social deprivation, and regional social public expenditure on one side, and self-perceived health in Spain (2007-2011) on the other. Longitudinal data were extracted from the Survey on Living Conditions, 2007-2010 and 2008-2011 (9105 individuals and 36,420 observations), which were then used to estimate several random group effects in the constant multilevel logistic longitudinal models (level 1: year; level 2: individual; level 3: region). The dependent variable was self-perceived health. Individual independent interest variables were long and very long term unemployment, available income, severe material deprivation and regional variables were per capita expenditure on essential public services and per capita health care expenditure. All of the estimated models show a robust association between bad perceived health and the variables of interest. When compared to employed individuals, long term unemployment increases the odds of reporting bad health by 22% to 67%; very long-term unemployment (24 to 48 months) increases the odds by 54% to 132%. Family income reduces the odds of reporting bad health by 16% to 28% for each additional percentage point in income. Being a member of a household with severe material deprivation increases the odds of perceiving one's health as bad by between 70% and 140%. Regionally, per capita expenditure on essential public services increases the odds of reporting good health, although the effect of this association was limited. Long and very long term unemployment, available income and poverty were associated to self-perceived bad health in Spain during the financial crisis. Regional expenditure on fundamental public services is also associated to poor self-perceived health, although in a more limited fashion. Results suggest the positive role in health of active employment and redistributing income policies.

  8. Hypocalcemia in dairy cows: meta-analysis and dietary cation anion difference theory revisited.

    PubMed

    Lean, I J; DeGaris, P J; McNeil, D M; Block, E

    2006-02-01

    Data from 137 published trials involving 2,545 calvings were analyzed using random effects normal logistic regression models to identify risk factors for clinical hypocalcemia in dairy cows. The aim of the study was to examine which form, if any, of the dietary cation anion difference (DCAD) equation provided the best estimate of milk fever risk and to clarify roles of calcium, magnesium, and phosphorus concentrations of prepartum diets in the pathogenesis of milk fever. Two statistically equivalent and biologically plausible models were developed that predict incidence of milk fever. These models were validated using data from 37 trials excluded from the original data used to generate the models; missing variables were replaced with mean values from the analyzed data. The preferred models differed slightly; Model 1 included prepartum DCAD, and Model 2 included prepartum dietary concentrations of potassium and sulfur alone, but not sodium and chloride. Other factors, included in both models were prepartum dietary concentrations of calcium, magnesium, phosphorus; days exposed to the prepartum diet; and breed. Jersey cows were at 2.25 times higher risk of milk fever than Holstein cows in Model 1. The results support the DCAD theory of greater risk of milk fever with higher prepartum dietary DCAD (odds ratio = 1.015). The only DCAD equation supported in statistical analyses was (Na(+) + K(+)) - (Cl(-) + S(2-)). This finding highlights the difference between developing equations to predict DCAD and those to predict milk fever. The results support a hypothesis of a quadratic role for Ca in the pathogenesis of milk fever (model 1, odds ratio = 0.131; Model 2, odds ratio = 0.115). Milk fever risk was highest with a prepartum dietary concentration of 1.35% calcium. Increasing prepartum dietary magnesium concentrations had the largest effect on decreasing incidence of milk fever in both Model 1 (odds ratio = 0.006) and Model 2 (odds ratio = 0.001). Increasing dietary phosphorus concentrations prepartum increased the risk of milk fever (Model 1, odds ratio = 6.376; Model 2, odds ratio = 9.872). The models presented provide the basis for the formulation of diets to reduce the risk of milk fever and strongly support the need to evaluate macro mineral nutrition apart from DCAD of the diet.

  9. Factors influencing repeated teenage pregnancy: a review and meta-analysis.

    PubMed

    Maravilla, Joemer C; Betts, Kim S; Couto E Cruz, Camila; Alati, Rosa

    2017-11-01

    Existing evidence of predictors of repeated teenage pregnancy has not been assessed rigorously. This systematic review provides a comprehensive evaluation of protective and risk factors that are associated with repeated teenage pregnancy through a metaanalytical consensus. We used PubMed, EMBASE, CINAHL, ProQuest, PsychINFO, ScienceDirect, Scopus, and Web of Science databases from 1997-2015 and the reference list of other relevant research papers and related reviews. Eligibility criteria included (1) epidemiologic studies that analyzed factors associated with repeated pregnancy or birth among adolescents <20 years of age who were nulliparous or experienced at least 1 pregnancy, and (2) experimental studies with an observational component that was adjusted for the intervention. We performed narrative synthesis of study characteristics, participant characteristics, study results, and quality assessment. We also conducted random-effects and quality-effects metaanalyses with meta-regression to obtain pooled odds ratios of identified factors and to determine sources of between-study heterogeneity. Twenty-six eligible epidemiologic studies, most from the United States (n=24), showed >47 factors with no evidence of publication bias for each metaanalysis. Use of contraception (pooled odds ratio, 0.60; 95% confidence interval, 0.35-1.02), particularly long-acting reversible contraceptives (pooled odds ratio, 0.19; 95% confidence interval, 0.08-0.45), considerably reduced repeated teenage pregnancy risk. Among studies about contraception, the number of follow-up visits (adjusted coefficient, 0.72; P=.102) and country of study (unadjusted coefficient, 2.57; permuted P=.071) explained between-study heterogeneity. Education-related factors, which included higher level of education (pooled odds ratio, 0.74; 95% confidence interval, 0.60-0.91) and school continuation (pooled odds ratio, 0.53; 95% confidence interval, 0.33-0.84), were found to be protective. Conversely, depression (pooled odds ratio, 1.46; 95% confidence interval, 1.14-1.87), history of abortion (pooled odds ratio, 1.66; 95% confidence interval, 1.08-2.54), and relationship factors, such as partner support, increased the repeated teenage pregnancy risk. Contraceptive use, educational factors, depression, and a history of abortion are the highly influential predictors of repeated teenage pregnancy. However, there is a lack of epidemiologic studies in low- and middle-income countries to measure the extent and characteristics of repeated teenage pregnancy across more varied settings. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Low-Dose vs Standard-Dose Alteplase for Patients With Acute Ischemic Stroke: Secondary Analysis of the ENCHANTED Randomized Clinical Trial.

    PubMed

    Wang, Xia; Robinson, Thompson G; Lee, Tsong-Hai; Li, Qiang; Arima, Hisatomi; Bath, Philip M; Billot, Laurent; Broderick, Joseph; Demchuk, Andrew M; Donnan, Geoffrey; Kim, Jong S; Lavados, Pablo; Lindley, Richard I; Martins, Sheila O; Olavarria, Veronica V; Pandian, Jeyaraj D; Parsons, Mark W; Pontes-Neto, Octavio M; Ricci, Stefano; Sharma, Vijay K; Thang, Nguyen H; Wang, Ji-Guang; Woodward, Mark; Anderson, Craig S; Chalmers, John

    2017-11-01

    A lower dose of intravenous alteplase appears to be a safer treatment option than the standard dose, reducing the risk of symptomatic intracerebral hemorrhage. There is uncertainty, however, over how this effect translates into an overall clinical benefit for patients with acute ischemic stroke (AIS). To assess whether older, Asian, or severely affected patients with AIS who are considered at high risk of thrombolysis may benefit more from low-dose rather than standard-dose alteplase treatment. This study is a prespecified secondary analysis of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED), an international, randomized, open-label, blinded, end-point clinical trial of low-dose vs standard-dose intravenous alteplase for patients with AIS. From March 1, 2012, to August 31, 2015, a total of 3310 patients who had a clinical diagnosis of AIS as confirmed by brain imaging and who fulfilled the local criteria for thrombolysis treatment were included in the alteplase-dose arms. Patients were randomly assigned to receive low-dose (0.6 mg/kg; 15% as bolus and 85% as infusion over 1 hour) or standard-dose (0.9 mg/kg; 10% as bolus and 90% as infusion over 1 hour) alteplase. Of the 3310 randomized patients, 13 patients were excluded for missing consent, mistaken randomization, and duplicate randomization numbers. This secondary analysis was conducted between May 1, 2016, and April 28, 2017. The primary end point was a poor outcome defined by the combination of death and any disability as scored by the modified Rankin Scale (scores range from 2 to 6, with the highest score indicating death) at 90 days. Of the 3297 patients included in the analysis, 1248 (37.9%) were women, and the mean (SD) age was 67 (13) years. No significant differences in the treatment effects were observed between low- and standard-dose alteplase for poor outcomes (death or disability) by age, ethnicity, or severity (all P > .37 for interaction). Similarly, the treatment effects of low- vs standard-dose alteplase on function outcome (ordinal shift of the modified Rankin Scale) in Asians (odds ratio, 1.05; 95% CI, 0.90-1.22) was consistent with non-Asians (odds ratio, 0.93; 95% CI, 0.76-1.14) (P = .32 for interaction). There were generally consistent reductions in rates of symptomatic intracerebral hemorrhage with low-dose alteplase, although this reduction was not statistically significant by age, ethnicity, or severity. This analysis found that the effects of low-dose alteplase were not clearly superior to the effects of standard-dose alteplase on death or disability in key demographic subgroups of patients with AIS. Further investigation is required to identify patients with AIS who may benefit from low-dose alteplase. clinicaltrials.gov Identifier: NCT01422616.

  11. Risk of fetal death in growth-restricted fetuses with umbilical and/or ductus venosus absent or reversed end-diastolic velocities before 34 weeks of gestation: a systematic review and meta-analysis.

    PubMed

    Caradeux, J; Martinez-Portilla, R J; Basuki, T R; Kiserud, T; Figueras, F

    2018-02-01

    The objective of the study was to establish the risk of fetal death in early-onset growth-restricted fetuses with absent or reversed end-diastolic velocities in the umbilical artery or ductus venosus. A systematic search was performed to identify relevant studies published in English, Spanish, French, Italian, or German using the databases PubMed, ISI Web of Science, and SCOPUS, without publication time restrictions. The study criteria included observational cohort studies and randomized controlled trials of early-onset growth-restricted fetuses (diagnosed before 34 weeks of gestation), with information on the rate of fetal death occurring before 34 weeks of gestation and absent or reversed end-diastolic velocities in the umbilical artery and/or ductus venosus. For quality assessment, 2 reviewers independently assessed the risk of bias using the Newcastle-Ottawa Scale for observational studies and the Cochrane Collaboration's tool for randomized trials. For the meta-analysis, odds ratio for both fixed and random-effects models (weighting by inverse of variance) were used. Heterogeneity between studies was assessed using tau 2 , χ2 (Cochrane Q), and I 2 statistics. Publication bias was assessed by a funnel plot for meta-analyses and quantified by the Egger method. A total of 31 studies were included in this meta-analysis. The odds ratios for fetal death (random-effects models) were 3.59 (95% confidence interval, 2.3-5.6), 7.27 (95% confidence interval, 4.6-11.4), and 11.6 (95% confidence interval, 6.3-19.7) for growth-restricted fetuses with umbilical artery absent end-diastolic velocities, umbilical artery reversed end-diastolic velocities, and ductus venosus absent or reversed end-diastolic velocities, respectively. There was no substantial heterogeneity among studies for any of the analyses. Early-onset growth-restricted fetuses with either umbilical artery or ductus venosus absent or reserved end-diastolic velocities are at a substantially increased risk for fetal death. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. The impact of low-dose aspirin on preterm birth: secondary analysis of a randomized controlled trial.

    PubMed

    Allshouse, A A; Jessel, R H; Heyborne, K D

    2016-06-01

    The objective of this study is to determine whether low-dose aspirin (LDA) reduced the rate of preterm birth (PTB) in a cohort of women at high risk for preeclampsia. Secondary analysis of the Maternal-Fetal Medicine Units High-Risk Aspirin trial. Preterm births were categorized by phenotype: indicated, spontaneous or due to preterm premature rupture of membranes (PPROMs). Of 1789 randomized women, 30.5% delivered before 37 weeks (18.5% indicated, 5.8% spontaneous and 6.2% following preterm PPROMs). Among women randomized to LDA, we observed a trend favoring fewer PTBs due to spontaneous preterm labor and preterm PPROMs, odds ratio (OR: 0.826 (0.620, 1.099)); the incidence of indicated PTBs appeared unchanged, OR: 0.999 (0.787, 1.268). Although not reaching significance, we observed an effect size similar to other studies of both low- and high-risk women. These results support findings from other studies assessing LDA as a PTB prevention strategy.

  13. HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV Infection in Young Women in South Africa-Study Design and Baseline Results.

    PubMed

    Pettifor, Audrey; MacPhail, Catherine; Selin, Amanda; Gómez-Olivé, F Xavier; Rosenberg, Molly; Wagner, Ryan G; Mabuza, Wonderful; Hughes, James P; Suchindran, Chirayath; Piwowar-Manning, Estelle; Wang, Jing; Twine, Rhian; Daniel, Tamu; Andrew, Philip; Laeyendecker, Oliver; Agyei, Yaw; Tollman, Stephen; Kahn, Kathleen

    2016-09-01

    Young women in South Africa are at high risk for HIV infection. Cash transfers offer promise to reduce HIV risk. We present the design and baseline results from HPTN 068, a phase III, individually randomized trial to assess the effect of a conditional cash transfer on HIV acquisition among South African young women. A total of 2533 young women were randomized to receive a monthly cash transfer conditional on school attendance or to a control group. A number of individual-, partner-, household- and school-level factors were associated with HIV and HSV-2 infection. After adjusting for age, all levels were associated with an increased odds of HIV infection with partner-level factors conveying the strongest association (aOR 3.05 95 % CI 1.84-5.06). Interventions like cash transfers that address structural factors such as schooling and poverty have the potential to reduce HIV risk in young women in South Africa.

  14. Double-Blind Prospective Randomized Controlled Trial of Dopamine Versus Epinephrine as First-Line Vasoactive Drugs in Pediatric Septic Shock.

    PubMed

    Ventura, Andréa M C; Shieh, Huei Hsin; Bousso, Albert; Góes, Patrícia F; de Cássia F O Fernandes, Iracema; de Souza, Daniela C; Paulo, Rodrigo Locatelli Pedro; Chagas, Fabiana; Gilio, Alfredo E

    2015-11-01

    The primary outcome was to compare the effects of dopamine or epinephrine in severe sepsis on 28-day mortality; secondary outcomes were the rate of healthcare-associated infection, the need for other vasoactive drugs, and the multiple organ dysfunction score. Double-blind, prospective, randomized controlled trial from February 1, 2009, to July 31, 2013. PICU, Hospital Universitário da Universidade de São Paulo, Brazil. Consecutive children who are 1 month to 15 years old and met the clinical criteria for fluid-refractory septic shock. Exclusions were receiving vasoactive drug(s) prior to hospital admission, having known cardiac disease, having already participated in the trial during the same hospital stay, refusing to participate, or having do-not-resuscitate orders. Patients were randomly assigned to receive either dopamine (5-10 μg/kg/min) or epinephrine (0.1-0.3 μg/kg/min) through a peripheral or intraosseous line. Patients not reaching predefined stabilization criteria after the maximum dose were classified as treatment failure, at which point the attending physician gradually stopped the study drug and started another catecholamine. Physiologic and laboratory data were recorded. Baseline characteristics were described as proportions and mean (± SD) and compared using appropriate statistical tests. Multiple regression analysis was performed, and statistical significance was defined as a p value of less than 0.05. Baseline characteristics and therapeutic interventions for the 120 children enrolled (63, dopamine; 57, epinephrine) were similar. There were 17 deaths (14.2%): 13 (20.6%) in the dopamine group and four (7%) in the epinephrine group (p=0.033). Dopamine was associated with death (odds ratio, 6.5; 95% CI, 1.1-37.8; p=0.037) and healthcare-associated infection (odds ratio, 67.7; 95% CI, 5.0-910.8; p=0.001). The use of epinephrine was associated with a survival odds ratio of 6.49. Dopamine was associated with an increased risk of death and healthcare-associated infection. Early administration of peripheral or intraosseous epinephrine was associated with increased survival in this population. Limitations should be observed while interpreting these results.

  15. Use of a Social and Character Development Program to Prevent Substance Use, Violent Behaviors, and Sexual Activity Among Elementary-School Students in Hawaii

    PubMed Central

    Flay, Brian R.; Vuchinich, Samuel; Snyder, Frank J.; Acock, Alan; Li, Kin-Kit; Burns, Kate; Washburn, Isaac J.; Durlak, Joseph

    2009-01-01

    Objectives. We assessed the effectiveness of a 5-year trial of a comprehensive school-based program designed to prevent substance use, violent behaviors, and sexual activity among elementary-school students. Methods. We used a matched-pair, cluster-randomized, controlled design, with 10 intervention schools and 10 control schools. Fifth-graders (N = 1714) self-reported on lifetime substance use, violence, and voluntary sexual activity. Teachers of participant students reported on student (N = 1225) substance use and violence. Results. Two-level random-effects count models (with students nested within schools) indicated that student-reported substance use (rate ratio [RR] = 0.41; 90% confidence interval [CI] = 0.25, 0.66) and violence (RR = 0.42; 90% CI = 0.24, 0.73) were significantly lower for students attending intervention schools. A 2-level random-effects binary model indicated that sexual activity was lower (odds ratio = 0.24; 90% CI = 0.08, 0.66) for intervention students. Teacher reports substantiated the effects seen for student-reported data. Dose-response analyses indicated that students exposed to the program for at least 3 years had significantly lower rates of all negative behaviors. Conclusions. Risk-related behaviors were substantially reduced for students who participated in the program, providing evidence that a comprehensive school-based program can have a strong beneficial effect on student behavior. PMID:19542037

  16. Use of Lipid-Based Nutrient Supplements by HIV-Infected Malawian Women during Lactation Has No Effect on Infant Growth from 0 to 24 Weeks1234

    PubMed Central

    Flax, Valerie L.; Bentley, Margaret E.; Chasela, Charles S.; Kayira, Dumbani; Hudgens, Michael G.; Knight, Rodney J.; Soko, Alice; Jamieson, Denise J.; van der Horst, Charles M.; Adair, Linda S.

    2012-01-01

    The Breastfeeding, Antiretrovirals, and Nutrition Study evaluated the effect of daily consumption of lipid-based nutrient supplements (LNS) by 2121 lactating, HIV-infected mothers on the growth of their exclusively breast-fed, HIV-uninfected infants from 0 to 24 wk. The study had a 2 × 3 factorial design. Malawian mothers with CD4+ ≥250 cells/mm3, hemoglobin ≥70 g/L, and BMI ≥17 kg/m2 were randomized within 36 h of delivery to receive either no LNS or 140 g/d of LNS to meet lactation energy and protein needs, and mother-infant pairs were assigned to maternal antiretroviral drugs (ARV), infant ARV, or no ARV. Sex-stratified, longitudinal, random effects models were used to estimate the effect of the 6 study arms on infant weight, length, and BMI. Logistic regression models were used to calculate the odds of growth faltering [decline in weight-for-age Z-score (WAZ) or length-for-age Z-score (LAZ) >0.67] using the control arm as the reference. Although some differences between study arms emerged with increasing infant age in boys, there were no consistent effects of the maternal supplement across the 3 growth outcomes in longitudinal models. At the ages where differences were observed, the effects on weight and BMI were quite small (≤200 g and ≤0.4 kg/m2) and unlikely to be of clinical importance. Overall, 21 and 34% of infants faltered in WAZ and LAZ, respectively. Maternal supplementation did not reduce the odds of infant weight or length faltering from 0 to 24 wk in any arm. These results indicate that blanket supplementation of HIV-infected lactating women may have little impact on infant growth. PMID:22649265

  17. Impact of advance directives and a health care proxy on doctors' decisions: a randomized trial.

    PubMed

    Escher, Monica; Perneger, Thomas V; Rudaz, Sandrine; Dayer, Pierre; Perrier, Arnaud

    2014-01-01

    Advance directives or proxy designations are widely recommended, but how they affect doctors' decision making is not well known. The aim of this study was to quantify the influence of advance directives and proxy opinions on doctors' decisions. We mailed to all the generalists and internists in French-speaking Switzerland (N = 1962) three vignettes describing difficult decisions involving incapacitated patients. In each case, the advance directive requested that further care be withheld. One vignette tested the impact of a written advance directive vs. a proxy. Another compared the impact of a handwritten directive vs. a formalized document. The third vignette compared the impact of a family member vs. a doctor as a proxy. Each vignette was prepared in three or four versions, including a control version in which no directive or proxy was present. Vignettes were randomly allocated to respondents. We used logistic regression to predict the decision to forgo a medical intervention. Compared with the control condition, the odds of forgoing a medical intervention were increased by the written advance directive (odds ratio [OR] 7.3; P < 0.001), the proxy (OR 7.9; P < 0.001), and the combination of the two (OR 35.7; P < 0.001). The handwritten directive had the same impact (OR 13.3) as the formalized directive (OR 13.8). The effect of proxy opinion was slightly stronger when provided by a doctor (OR 11.3) rather than by family (OR 7.8). Advance directives and proxy opinions are equally effective in influencing doctors' decisions, but having both has the strongest effect. The format of the advance directive and the identity of the proxy have little influence on decisions. Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  18. Health impact and cost-effectiveness of a private sector bed net distribution: experimental evidence from Zambia.

    PubMed

    Sedlmayr, Richard; Fink, Günther; Miller, John M; Earle, Duncan; Steketee, Richard W

    2013-03-18

    Relatively few programmes have attempted to actively engage the private sector in national malaria control efforts. This paper evaluates the health impact of a large-scale distribution of insecticide-treated nets (ITNs) conducted in partnership with a Zambian agribusiness, and its cost-effectiveness from the perspective of the National Malaria Control Programme (NMCP). The study was designed as a cluster-randomized controlled trial. A list of 81,597 cotton farmers was obtained from Dunavant, a contract farming company in Zambia's cotton sector, in December 2010. 39,963 (49%) were randomly selected to obtain one ITN each. Follow-up interviews were conducted with 438 farmers in the treatment and 458 farmers in the control group in June and July 2011. Treatment and control households were compared with respect to bed net ownership, bed net usage, self-reported fever, and self-reported confirmed malaria. Cost data was collected throughout the programme. The distribution effectively reached target beneficiaries, with approximately 95% of households in the treatment group reporting that they had received an ITN through the programme. The average increase in the fraction of household members sleeping under an ITN the night prior to the interview was 14.6 percentage points (p-value <0.001). Treatment was associated with a 42 percent reduction in the odds of self-reported fever (p-value <0.001) and with a 49 percent reduction in the odds of self-reported malaria (p-value 0.002). This was accomplished at a cost of approximately five US$ per ITN to Zambia's NMCP. The results illustrate that existing private sector networks can efficiently control malaria in remote rural regions. The intra-household allocation of ITNs distributed through this channel was comparable to that of ITNs received from other sources, and the health impact remained substantial.

  19. Epidural Analgesia With Bupivacaine and Fentanyl Versus Ropivacaine and Fentanyl for Pain Relief in Labor

    PubMed Central

    Guo, Shanbin; Li, Bo; Gao, Chengjie; Tian, Yue

    2015-01-01

    Abstract The aim of this study was to compare the efficacy and safety of the combinational use of bupivacaine and fentanyl versus ropivacaine and fentanyl in epidural analgesia for labor. Multiple electronic databases were searched by using appropriate MeSH terms, and keywords for original research papers published before October 2014. Meta-analyses were based on mean differences between the groups as well as odds ratios. Statistical heterogeneity was tested by I2 index. Fifteen randomized controlled trials, recruiting 2097 parturient mothers overall, were selected for the meta-analyses. Concentrations of the preparations used (weight/volume; mean and standard deviations) were bupivacaine 0.1023% ± 0.0375%, ropivacaine 0.1095% ± 0.042%, and fentanyl 0.00021% ± 0.000089%. There were no statistically significant differences between both the combinations in the mean change in Visual Analog Score for pain during labor, incidence of instrumental or cesarean delivery, neonate Apgar score of <7, maternal satisfaction, duration of either first or second stage of labor, oxytocin use for induction, onset of analgesia, and duration of analgesia. Women who received ropivacaine and fentanyl had significantly lower incidence of motor blocks (odds ratio [95% CI] = 0.38 [0.30, 0.48] P < 0.00001, fixed effect and 0.38 [0.27, 0.54] P < 0.0001, random effects I2 30%) when compared with women who received bupivacaine and fentanyl. Incidence of side effects was similar for both the combinations. Analgesia with ropivacaine in combination with fentanyl at 0.1%:0.0002% ratio for labor pain relief is associated with lower incidence of motor blocks in comparison with analgesia with bupivacaine and fentanyl at similar ratio (0.1%: 0.0002%). PMID:26061307

  20. A Rights-Based Sexuality Education Curriculum for Adolescents: 1-Year Outcomes From a Cluster-Randomized Trial.

    PubMed

    Rohrbach, Louise A; Berglas, Nancy F; Jerman, Petra; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Constantine, Norman A

    2015-10-01

    The purpose of this study was to evaluate the impact of a rights-based sexuality education curriculum on adolescents' sexual health behaviors and psychosocial outcomes 1 year after participation. Within 10 urban high schools, ninth-grade classrooms were randomized to receive a rights-based curriculum or a basic sex education (control) curriculum. The intervention was delivered across two school years (2011-2012, 2012-2013). Surveys were completed by 1,447 students at pretest and 1-year follow-up. Multilevel analyses examined curriculum effects on behavioral and psychosocial outcomes, including four primary outcomes: pregnancy risk, sexually transmitted infection risk, multiple sexual partners, and use of sexual health services. Students receiving the rights-based curriculum had higher scores than control curriculum students on six of nine psychosocial outcomes, including sexual health knowledge, attitudes about relationship rights, partner communication, protection self-efficacy, access to health information, and awareness of sexual health services. These students also were more likely to report use of sexual health services (odds ratio, 1.37; 95% confidence interval, 1.05-1.78) and more likely to be carrying a condom (odds ratio, 1.97; 95% confidence interval, 1.39-2.80) relative to those receiving the control curriculum. No effects were found for other sexual health behaviors, possibly because of low prevalence of sexual activity in the sample. The curriculum had significant, positive effects on psychosocial and some behavioral outcomes 1 year later, but it might not be sufficient to change future sexual behaviors among younger adolescents, most of whom are not yet sexually active. Booster education sessions might be required throughout adolescence as youth initiate sexual relationships. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  1. Continuing or Temporarily Stopping Prestroke Antihypertensive Medication in Acute Stroke: An Individual Patient Data Meta-Analysis.

    PubMed

    Woodhouse, Lisa J; Manning, Lisa; Potter, John F; Berge, Eivind; Sprigg, Nikola; Wardlaw, Joanna; Lees, Kennedy R; Bath, Philip M; Robinson, Thompson G

    2017-05-01

    Over 50% of patients are already taking blood pressure-lowering therapy on hospital admission for acute stroke. An individual patient data meta-analysis from randomized controlled trials was undertaken to determine the effect of continuation versus temporarily stopping preexisting antihypertensive medication in acute stroke. Key databases were searched for trials against the following inclusion criteria: randomized design; stroke onset ≤48 hours; investigating the effect of continuation versus stopping prestroke antihypertensive medication; and follow-up of ≥2 weeks. Two randomized controlled trials were identified and included in this meta-analysis of individual patient data from 2860 patients with ≤48 hours of acute stroke. Risk of bias in each study was low. In adjusted logistic regression and multiple regression analyses (using random effects), we found no significant association between continuation of prestroke antihypertensive therapy (versus stopping) and risk of death or dependency at final follow-up: odds ratio 0.96 (95% confidence interval, 0.80-1.14). No significant associations were found between continuation (versus stopping) of therapy and secondary outcomes at final follow-up. Analyses for death and dependency in prespecified subgroups revealed no significant associations with continuation versus temporarily stopping therapy, with the exception of patients randomized ≤12 hours, in whom a difference favoring stopping treatment met statistical significance. We found no significant benefit with continuation of antihypertensive treatment in the acute stroke period. Therefore, there is no urgency to administer preexisting antihypertensive therapy in the first few hours or days after stroke, unless indicated for other comorbid conditions. © 2017 American Heart Association, Inc.

  2. Maltreatment and Affective and Behavioral Problems in Emerging Adults With and Without Oppositional Defiant Disorder Symptoms: Mediation by Parent-Child Relationship Quality.

    PubMed

    McKinney, Cliff; Stearns, Melanie; Szkody, Erica

    2018-03-01

    The current study examined the indirect effect of maternal and paternal emotional and physical maltreatment on affective and behavioral symptoms of oppositional defiant disorder (ODD) through parent-child relationship quality; gender and overall ODD symptoms were examined as moderators. Participants included 2,362 emerging adults who completed questionnaires about parental emotional and physical maltreatment, parent-child relationship quality, and affective and behavioral ODD symptoms. These characteristics were compared across parent and child gender (i.e., maternal and paternal effects as well as male and female differences) as well as participants reporting high and low ODD symptoms. In the low ODD group, indirect effects of emotional maltreatment occurred in all parent-child dyads except the mother-son dyad, whereas in the high ODD group, indirect effects occurred only in the father-son dyad. Indirect effects of physical maltreatment occurred only in the father-son dyad in the low ODD group, and only in the mother-daughter dyad on behavioral ODD symptoms in the high ODD group. The results suggest that specific parent-child gender dyads respond differently, warranting further investigation of gender effects. Moreover, emerging adults in the low ODD symptoms group demonstrated a positive association between parental maltreatment and ODD symptoms and a negative association between parent-child relationship quality and ODD symptoms, whereas those high in the high ODD symptoms group did not demonstrate these associations. That is, emerging adults reporting high ODD symptoms demonstrated no relationship between their ODD symptoms and harsh parenting, suggesting an ineffective coercive process.

  3. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain.

    PubMed

    van Kleef, M; Barendse, G A; Kessels, A; Voets, H M; Weber, W E; de Lange, S

    1999-09-15

    A prospective double-blind randomized trial in 31 patients. To assess the clinical efficacy of percutaneous radiofrequency denervation of the lumbar zygapophysial joints in reducing pain, functional disability, and physical impairment in patients with back pain originating from the lumbar zygapophysial joints. Chronic low back pain is a major health problem in the industrialized world. A treatment option is percutaneous radiofrequency denervation of the lumbar zygapophysial joints. Its clinical efficacy has never been formally tested in a controlled trial. Thirty-one patients with a history of at least 1 year of chronic low back pain were selected on the basis of a positive response to a diagnostic nerve blockade and subsequently randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (15 patients) received an 80 C radiofrequency lesion of the dorsal ramus of the segmental nerve roots L3, L4, and L5. Patients in the control group (n = 16) underwent an the same procedure but without use of a radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator. Eight weeks after treatment, there were 10 success patients in the radiofrequency group (n = 15) and 6 in the sham group (n = 16). The unadjusted odds ratio was 3.3 (P = 0.05, not significant), and the adjusted odds ratio was 4.8 (P < 0.05, significant). The differences in effect on the visual analog scale scores, global perceived effect, and the Oswestry disability scale were statistically significant. Three, 6, and 12 months after treatment, there were significantly more success patients in the radiofrequency group compared with the sham group. Radiofrequency lumbar zygapophysial joint denervation results in a significant alleviation of pain and functional disability in a select group of patients with chronic low back pain, both on a short-term and a long-term basis.

  4. Does the efficacy of parent-child training depend on maternal symptom improvement? Results from a randomized controlled trial on children and mothers both affected by attention-deficit/hyperactivity disorder (ADHD).

    PubMed

    Häge, Alexander; Alm, Barbara; Banaschewski, Tobias; Becker, Katja; Colla, Michael; Freitag, Christine; Geissler, Julia; von Gontard, Alexander; Graf, Erika; Haack-Dees, Barbara; Hänig, Susann; Hennighausen, Klaus; Hohmann, Sarah; Jacob, Christian; Jaite, Charlotte; Jennen-Steinmetz, Christine; Kappel, Viola; Matthies, Swantje; Philipsen, Alexandra; Poustka, Luise; Retz, Wolfgang; Rösler, Michael; Schneider-Momm, Katja; Sobanski, Esther; Vloet, Timo D; Warnke, Andreas; Jans, Thomas

    2018-01-23

    Multimodal treatment of children with ADHD often includes parent-child training (PCT). However, due to the high heritability, parents of children with ADHD are frequently also affected by the disorder, which is likely to constitute a significant barrier to successful treatment of the child. This secondary analysis of our randomized controlled multicentre AIMAC trial (ADHD in mothers and children) investigates whether children's outcomes following parent-child training in combination with maternal ADHD treatment depend on maternal symptom improvement. In a first step focusing on treatment of maternal ADHD, 144 mothers of mother-child dyads were randomized to multimodal ADHD treatment (group psychotherapy plus methylphenidate) or clinical management (mainly supportive counselling). After 12 weeks (T2), a 12-week PCT program (T2-T3) for all mother-child dyads was added to treat children's ADHD. Maternal symptomatology (CAARS-O:L; SCL-90-R) and children's externalizing symptoms (ADHD-ODD Scale, SDQ) were repeatedly assessed (T1 = baseline, T2, T3). Effects of changes in maternal symptomatology (T1-T2) on the change in children's symptom scores (T1-T3) were analysed using a general linear model, controlling for baseline scores, study centre, and maternal treatment group. 125 mother-child dyads were analysed. Mothers showed significant improvements in ADHD symptoms and overall psychopathology [CAARS-O:L ADHD index: mean - 3.54, SE 0.74 p < 0.0001; SCL-90-R Global Severity (GS): mean - 11.03, SE 3.90, p = 0.0056]. Although children's externalizing symptoms improved significantly (ADHD-ODD Scale: mean - 4.46, SE 0.58, p < 0.0001), maternal improvement had no effect on children's outcomes after Bonferroni-Holm correction for multiple testing. The findings do not support our hypothesis that children's outcomes following PCT for ADHD depend on maternal symptom improvements.Trial register CCT-ISRCTN73911400.

  5. The Effectiveness of Alcohol Screening and Brief Intervention in Emergency Departments: A Multicentre Pragmatic Cluster Randomized Controlled Trial

    PubMed Central

    Drummond, Colin; Deluca, Paolo; Coulton, Simon; Bland, Martin; Cassidy, Paul; Crawford, Mike; Dale, Veronica; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; McGovern, Ruth; Myles, Judy; Newbury-Birch, Dorothy; Oyefeso, Adenekan; Parrott, Steve; Patton, Robert; Perryman, Katherine; Phillips, Tom; Shepherd, Jonathan; Touquet, Robin; Kaner, Eileen

    2014-01-01

    Background Alcohol misuse is common in people attending emergency departments (EDs) and there is some evidence of efficacy of alcohol screening and brief interventions (SBI). This study investigated the effectiveness of SBI approaches of different intensities delivered by ED staff in nine typical EDs in England: the SIPS ED trial. Methods and Findings Pragmatic multicentre cluster randomized controlled trial of SBI for hazardous and harmful drinkers presenting to ED. Nine EDs were randomized to three conditions: a patient information leaflet (PIL), 5 minutes of brief advice (BA), and referral to an alcohol health worker who provided 20 minutes of brief lifestyle counseling (BLC). The primary outcome measure was the Alcohol Use Disorders Identification Test (AUDIT) status at 6 months. Of 5899 patients aged 18 or more presenting to EDs, 3737 (63·3%) were eligible to participate and 1497 (40·1%) screened positive for hazardous or harmful drinking, of whom 1204 (80·4%) gave consent to participate in the trial. Follow up rates were 72% (n = 863) at six, and 67% (n = 810) at 12 months. There was no evidence of any differences between intervention conditions for AUDIT status or any other outcome measures at months 6 or 12 in an intention to treat analysis. At month 6, compared to the PIL group, the odds ratio of being AUDIT negative for brief advice was 1·103 (95% CI 0·328 to 3·715). The odds ratio comparing BLC to PIL was 1·247 (95% CI 0·315 to 4·939). A per protocol analysis confirmed these findings. Conclusions SBI is difficult to implement in typical EDs. The results do not support widespread implementation of alcohol SBI in ED beyond screening followed by simple clinical feedback and alcohol information, which is likely to be easier and less expensive to implement than more complex interventions. Trial Registration Current Controlled Trials ISRCTN 93681536 PMID:24963731

  6. Chest closure without drainage after open patent ductus arteriosus ligation in Ugandan children: A non blinded randomized controlled trial.

    PubMed

    Kebba, Naomi; Mwambu, Tom; Oketcho, Michael; Izudi, Jonathan; Obuku, Ekwaro A

    2016-09-29

    There is clinical equipoise regarding post-operative management of patients with patent ductus arteriosus (PDA) without insertion of a chest drain. This study evaluated post operative outcomes of chest closure with or without a drain following Patent Ductus Arteriosus ligation among childen at Uganda Heart Instritute (UHI). This was an open label randomized controlled trial of 62 children 12 years of age and below diagnosed with patent ductus arteriosus at Mulago National Teaching and Referral Hospital, Uganda. Participants were randomized in the ratio of 1:1 with surgical ligation of patent ductus arteriosus to either thoracotomy closure with a chest tube or without a chest tube. All participants received standard care and were monitored hourly for 24 hours then until hospital discharge. The combined primary endpoint consisted of significant pleural space accumulation of fluid or air, higher oxygen need or infection of the surgical site. Analysis was conducted by multivariable logistic regression analysis at 5 % significance level. We enrolled 62 participants, 46 (74 %) of whom were females. Their median age was 12 months (IQR: 8-36). Participants in the no-drain arm significantly had less post-operative complications compared to the drain arm (Unadjusted odds ratio [uOR]: 0.21, 95 % CI: 0.06-0.73, p = 0.015). This "protective effect" remained without statistical significance in the multivariable regression model (Adjusted odds ratio [aOR]: 0.07, 95 % CI: 0.00-2.50, p = 0.144). Children aged below 6 years with patent ductus arterious can safely and effectively have thoracotomy closure without using a drain in uncomplicated surgical ligation of the PDA. Chest drain was associated with post-operative complications. The trial was registered in the Pan African Clinical Trials registry on 1st/July/2012, retrospectively registered. Identifier number PACTR201207000395469 .

  7. Predictors of long-term adherence to continuous positive airway pressure in patients with obstructive sleep apnoea and acute coronary syndrome

    PubMed Central

    Florés, Marina; Martinez-Alonso, Montserrat; Sánchezde-la-Torre, Alicia; Aldomà, Albina; Galera, Estefania; Barbé, Ferran; Sánchezde-la-Torre, Manuel

    2018-01-01

    Background Continuous positive airway pressure (CPAP) is an effective treatment for obstructive sleep apnoea (OSA), but an evaluation of CPAP adherence is rarely carried out among patients with acute coronary syndrome (ACS). The goals of the study are to analyse long-term adherence and identify the predictors of non-compliance with CPAP treatment for patients with non-sleepy OSA and ACS. Methods This is an ancillary study of the ISAACC study, which is a multicentre, prospective, open-label, parallel, randomized, and controlled trial (NCT01335087) in patients with hospital admission for ACS. For the purpose of this study, only non-sleepy patients with moderate or severe OSA and randomized to receive CPAP treatment were analysed (n=357). Non-compliance was defined as CPAP dropout or average cumulative CPAP use of <4 hours/night. Multivariable logistic regression analysis was performed to identify predictors of CPAP adherence. Results Adherence to treatment was 35.3% at 12 months. According to the unadjusted analysis, higher apnoea-hypopnea index (AHI) (P<0.001) and oxygen desaturation index (ODI) (P=0.001) were associated with a lower risk of non-compliance. Multivariable logistic regression analysis showed that high AHI (P=0.0051), high amounts of smoking pack-year (P=0.0170), and long intensive care unit (ICU) stays (P=0.0263) were associated with lower odds of non-compliance. It also showed a significant interaction between ACS history and age (P=0.0131), such that young patients with their first ACS showed significantly lower odds of CPAP non-compliance than patients with recurrent ACS and significantly lower odds of CPAP non-compliance were associated with ageing only in patients with recurrent ACS. Conclusions Protective factors against non-compliance with CPAP treatment in non-sleepy patients with ACS were illness severity (high values of AHI or ICU stay length) or smoking amount. Patients with no previous history of ACS showed lower odds of CPAP non-compliance than patients with a recurrent ACS with younger age. PMID:29445536

  8. Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial.

    PubMed

    Forgie, Marie M; Greer, Danielle M; Kram, Jessica J F; Vander Wyst, Kiley B; Salvo, Nicole P; Siddiqui, Danish S

    2016-03-01

    Foley catheters are used for cervical ripening during induction of labor. Previous studies suggest that use of a stylette (a thin, rigid wire) to guide catheter insertion decreases insertion failure. However, stylette effects on insertion outcomes have been sparsely studied. The purpose of this study was to compare catheter insertion times, patient-assessed pain levels, and insertion failure rates between women who received a digitally placed Foley catheter for cervical ripening with the aid of a stylette and women who received the catheter without a stylette. We conducted a randomized clinical trial of women aged ≥ 18 years who presented for induction of labor. Inclusion criteria were singletons with intact membranes and cephalic presentation. Women received a computer-generated random assignment of a Foley catheter insertion with a stylette (treatment group, n = 62) or without a stylette (control group, n = 61). For all women, a standard insertion technique protocol was used. Three primary outcomes were of interest, including the following: (1) insertion time (total minutes to successful catheter placement), (2) patient-assessed pain level (0-10), and (3) failure rate of the randomly assigned insertion method. Treatment control differences were first examined using the Pearson's test of independence and the Student t test. Per outcome, we also constructed 4 regression models, each including the random effect of physician and fixed effects of stylette use with patient nulliparity, a history of vaginal delivery, cervical dilation at presentation, or postgraduate year of the performing resident physician. Women who received the Foley catheter with the stylette vs without the stylette did not differ by age, race/ethnicity, body mass index, or any of several other characteristics. Regression models revealed that insertion time, patient pain, and insertion failure were unrelated to stylette use, nulliparity, and history of vaginal delivery. However, overall insertion time and failure were significantly influenced by cervical dilation, with insertion time decreasing by 21% (95% confidence interval [CI], 5-34%) and odds of failure decreasing by 71% (odds ratio, 0.29; 95% CI, 0.10-0.86) per 1 cm dilation. Resident postgraduate year also significantly influenced insertion time, with greater time required of physicians with less experience. Mean insertion time was 51% (95% CI, 23-69%) shorter for fourth-year than second-year residents. Statistically nonsignificant but prominent patterns in outcomes were also observed, suggesting stylette use may lengthen the overall insertion procedure but minimize variability in pain levels and decrease insertion failure. The randomized trial suggests that, even after accounting for nulliparity, history of vaginal delivery, cervical dilation, and physician experience, Foley catheter insertions with and without a stylette are equivalent in insertion times, patient pain levels, and failure of catheter placement. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial.

    PubMed

    Shin, Dong Wook; Yun, Jae Moon; Shin, Jung-Hyun; Kwon, Hyuktae; Min, Hye Yeon; Joh, Hee-Kyung; Chung, Won Joo; Park, Jin Ho; Jung, Kee-Taig; Cho, BeLong

    2017-02-01

    A pilot randomized trial assessed the feasibility and effectiveness of an intervention combining Smartcare (activity tracker with a smartphone application) and financial incentives. A three-arm, open-label randomized controlled trial design involving traditional education, Smartcare, and Smartcare with financial incentives was involved in this study. The latter group received financial incentives depending on the achievement of daily physical activity goals (process incentive) and weight loss targets (outcome incentive). Male university students (N = 105) with body mass index of ≥27 were enrolled. The average weight loss in the traditional education, Smartcare, and Smartcare with financial incentives groups was -0.4, -1.1, and -3.1 kg, respectively, with significantly greater weight loss in the third group (both Ps < 0.01). The final weight loss goal was achieved by 0, 2, and 10 participants in the traditional education, Smartcare, and Smartcare with financial incentives groups (odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27, 95% confidence interval: 1.45-36.47). Levels of physical activity were significantly higher in this group. The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity. © 2017 The Obesity Society.

  10. More than just a question of technology: factors related to hospitals' adoption and implementation of health information exchange.

    PubMed

    Vest, Joshua R

    2010-12-01

    The provisions of the American Recovery & Reinvestment Act increased the likelihood of more widespread health information exchange (HIE), the electronic transfer of patient-level information between organizations, by essentially mandating the use of electronic health record systems. While important, the sparse body of research on HIE efforts and anecdotal reports indicate the barriers to HIE adoption and implementation include factors beyond simply the presence or absence of a specific technology. This paper examines those technological, organizational, and environmental factors that are associated with both HIE adoption and implementation in a sample of 4830 U.S. hospitals. Factors associated with adoption and implementation were modeled using random-intercept logistic regression. Consistent with a perspective that adoption and implementation are different phenomena, many factors associated with an increased odds of adoption, were unassociated with implementation and vice versa. Non-profit status, public hospitals, more live and operation applications, more emergency room visits, network membership, and the presence of physician portals all increased hospitals' odds of HIE adoption. However, only network membership increased the odds of HIE implementation, whereas competition decreased those odds significantly. This study agreed with earlier case-studies and anecdotal reports that factors beyond technology were important to both adoption and implementation. While current U.S. policy on healthcare information technology adoption focuses on technological barriers, many other non-technological factors may ultimately hinder effective HIE. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  11. Does aggressive surgical resection improve survival in advanced stage 3 and 4 neuroblastoma? A systematic review and meta-analysis.

    PubMed

    Mullassery, Dhanya; Farrelly, Paul; Losty, Paul D

    2014-11-01

    The role of surgery in the management of advanced staged neuroblastoma (NBL) is controversial. A systematic review and meta-analysis is reported to address robust evidence for curative "gross total tumor resection" (GTR) in Stage 3 and Stage 4 neuroblastoma. Studies were identified using Medline, Embase, and Cochrane databases using pre-specified search terms. Primary outcomes were 5-year overall (OS) and disease-free survival (DFS) after GTR and subtotal resection (STR) in Stage 3 or 4 NBL. Data were analyzed using Review Manager. The Mantel-Haenszel method and a random effects model was utilized to calculate odds ratios (95% CI). Fifteen studies (five Stage 3 and 13 Stage 4) met full inclusion criteria. The pooled odds ratio for 5 year OS in Stage 3 following GTR compared to STR was 2.4 (95% CI 1.19-4.85). In Stage 4 disease, the pooled odds ratio for 5 year overall survival (OS) following GTR compared to STR was 1.65 (95% CI 0.96-1.91); a pooled odds ratio for 5 year DFS following GTR compared to STR was 1.55 (95% CI 1.12-2.14). A clear survival benefit is shown for GTR over STR in Stage 3 NBL only. Though some advantage can be demonstrated for GTR as defined by DFS in Stage 4 NBL GTR did not significantly improve OS in Stage 4 disease.

  12. The palisade cartilage tympanoplasty technique: a systematic review and meta-analysis.

    PubMed

    Jeffery, Caroline C; Shillington, Cameron; Andrews, Colin; Ho, Allan

    2017-06-17

    Tympanoplasty is a common procedure performed by Otolaryngologists. Many types of autologous grafts have been used with variations of techniques with varying results. This is the first systematic review of the literature and meta-analysis with the aim to evaluate the effectiveness of one of the techniques which is gaining popularity, the palisade cartilage tympanoplasty. PubMed, EMBASE, and Cochrane databases were searched for "palisade", "cartilage", "tympanoplasty", "perforation" and their synonyms. In total, 199 articles reporting results of palisade cartilage tympanoplasty were identified. Five articles satisfied the following inclusion criteria: adult patients, minimum 6 months follow-up, hearing and surgical outcomes reported. Studies with patients undergoing combined mastoidectomy, ossicular chain reconstruction, and/or other middle ear surgery were excluded. Perforation closure, rate of complications, and post-operative pure-tone average change were extracted for pooled analysis. Study failure and complication proportions that were used to generate odds ratios were pooled. Fixed effects and random effects weightings were generated. The resulting pooled odds ratios are reported. Palisade cartilage tympanoplasty has an overall take rate of 96% at beyond 6 months and has similar odds of complications compared to temporalis fascia (OR 0.89, 95% CI 0.62, 1.30). The air-bone gap closure is statistically similar to reported results from temporalis fascia tympanoplasty. Cartilage palisade tympanoplasty offers excellent graft take rates and good postoperative hearing outcomes for perforations of various sizes and for both primary and revision cases. This technique has predictable, long-term results with low complication rates, similar to temporalis fascia tympanoplasty.

  13. Gestational syphilis and stillbirth in the Americas: a systematic review and meta-analysis.

    PubMed

    Arnesen, Lauren; Serruya, Suzanne; Duran, Pablo

    2015-06-01

    To perform a systematic review and meta-analysis of reported estimates of the association between gestational syphilis (GS) and stillbirth in the Americas region. Cochrane Library, Embase, LILACS, MEDLINE/PubMed, PLOS, and ScienceDirect were searched for original research studies quantifying the relationship between GS and stillbirth in the region. A final sample of eight studies was selected. A cumulative meta-analysis plus four subgroup meta-analyses of study data on the association between maternal syphilis during pregnancy and stillbirth were conducted. The four meta-analyses were based on 1) definition of cases and the control; 2) syphilis treatment (presence or absence, effective or ineffective); 3) definition of stillbirth as "showing no signs of life at birth"; and 4) definition of stillbirth based on low birth weight and gestational age. Random-effects metaanalyses were used to calculate pooled estimates of stillbirth with exposure to GS, and each subgroup analysis was tested for heterogeneity. Women with GS had increased odds of stillbirth (pooled odds ratio (OR): 6.87; 95% confidence interval: 2.93, 16.08). There was considerable heterogeneity across the eight studies (percentage of variance (I²) = 95). The funnel plot was not statistically significant, pointing to a lack of publication bias. Increased odds of stillbirth among pregnant women with syphilis were also seen in all four subgroup meta-analyses. GS is a major contributing factor for stillbirths in the Americas. Interventions targeting GS are highly cost-effective and, along with high-quality point-of-care testing, should be implemented across the region to help reach the goal of eliminating congenital syphilis.

  14. Abortion and mental health: quantitative synthesis and analysis of research published 1995-2009.

    PubMed

    Coleman, Priscilla K

    2011-09-01

    Given the methodological limitations of recently published qualitative reviews of abortion and mental health, a quantitative synthesis was deemed necessary to represent more accurately the published literature and to provide clarity to clinicians. To measure the association between abortion and indicators of adverse mental health, with subgroup effects calculated based on comparison groups (no abortion, unintended pregnancy delivered, pregnancy delivered) and particular outcomes. A secondary objective was to calculate population-attributable risk (PAR) statistics for each outcome. After the application of methodologically based selection criteria and extraction rules to minimise bias, the sample comprised 22 studies, 36 measures of effect and 877 181 participants (163 831 experienced an abortion). Random effects pooled odds ratios were computed using adjusted odds ratios from the original studies and PAR statistics were derived from the pooled odds ratios. Women who had undergone an abortion experienced an 81% increased risk of mental health problems, and nearly 10% of the incidence of mental health problems was shown to be attributable to abortion. The strongest subgroup estimates of increased risk occurred when abortion was compared with term pregnancy and when the outcomes pertained to substance use and suicidal behaviour. This review offers the largest quantitative estimate of mental health risks associated with abortion available in the world literature. Calling into question the conclusions from traditional reviews, the results revealed a moderate to highly increased risk of mental health problems after abortion. Consistent with the tenets of evidence-based medicine, this information should inform the delivery of abortion services.

  15. Nitrous Oxide and Serious Long-term Morbidity and Mortality in the Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II Trial.

    PubMed

    Leslie, Kate; Myles, Paul S; Kasza, Jessica; Forbes, Andrew; Peyton, Philip J; Chan, Matthew T V; Paech, Michael J; Sessler, Daniel I; Beattie, W Scott; Devereaux, P J; Wallace, Sophie

    2015-12-01

    The Evaluation of Nitrous Oxide in the Gas Mixture for Anaesthesia (ENIGMA)-II trial randomly assigned 7,112 noncardiac surgery patients at risk of perioperative cardiovascular events to 70% N2O or 70% N2 groups. The aim of this follow-up study was to determine the effect of nitrous oxide on a composite primary outcome of death and major cardiovascular events at 1 yr after surgery. One-year follow-up was conducted via a medical record review and telephone interview. Disability was defined as a Katz index of independence in activities of daily living score less than 8. Adjusted odds ratios and hazard ratios were calculated as appropriate for primary and secondary outcomes. Among 5,844 patients evaluated at 1 yr, 435 (7.4%) had died, 206 (3.5%) had disability, 514 (8.8%) had a fatal or nonfatal myocardial infarction, and 111 (1.9%) had a fatal or nonfatal stroke during the 1-yr follow-up period. Exposure to nitrous oxide did not increase the risk of the primary outcome (odds ratio, 1.08; 95% CI, 0.94 to 1.25; P = 0.27), disability or death (odds ratio, 1.07; 95% CI, 0.90 to 1.27; P = 0.44), death (hazard ratio, 1.17; 95% CI, 0.97 to 1.43; P = 0.10), myocardial infarction (odds ratio, 0.97; 95% CI, 0.81 to 1.17; P = 0.78), or stroke (odds ratio, 1.08; 95% CI, 0.74 to 1.58; P = 0.70). These results support the long-term safety of nitrous oxide administration in noncardiac surgical patients with known or suspected cardiovascular disease.

  16. Organizational Factors Affecting the Likelihood of Cancer Screening Among VA Patients.

    PubMed

    Chou, Ann F; Rose, Danielle E; Farmer, Melissa; Canelo, Ismelda; Yano, Elizabeth M

    2015-12-01

    Preventive service delivery, including cancer screenings, continues to pose a challenge to quality improvement efforts. Although many studies have focused on person-level characteristics associated with screening, less is known about organizational influences on cancer screening. This study aims to understand the association between organizational factors and adherence to cancer screenings. This study employed a cross-sectional design using organizational-level, patient-level, and area-level data. Dependent variables included breast, cervical, and colorectal cancer screening. Organizational factors describing resource sufficiency were constructed using factor analyses from a survey of 250 Veterans Affairs primary care directors. We conducted random-effects logistic regression analyses, modeling cancer screening as a function of organizational factors, controlling for patient-level and area-level factors. Overall, 87% of the patients received mammograms, 92% received cervical and 78% had colorectal screening. Quality improvement orientation increased the odds of cervical [odds ratio (OR): 1.27; 95% confidence interval (CI), 1.03-1.57] and colorectal cancer screening (OR: 1.10; 95% CI, 1.00-1.20). Authority in determining primary care components increased the odds of mammography screening (OR: 1.23; 95% CI, 1.03-1.51). Sufficiency in clinical staffing increased the odds of mammography and cervical cancer screenings. Several patient-level factors, serving as control variables, were associated with achievement of screenings. Resource sufficiency led to increased odds of screening possibly because they promote excellence in patient care by conveying organizational goals and facilitate goal achievement with resources. Complementary to patient-level factors, our findings identified organizational processes associated with better performance, which offer concrete strategies in which facilities can evaluate their capabilities to implement best practices to foster and sustain a culture of quality care.

  17. Engaging Parents Who Quit Smoking in Antismoking Socialization of Children: A Novel Approach to Relapse Prevention

    PubMed Central

    Hayes, Kim A.; Dickinson, Denise M.

    2016-01-01

    Abstract Introduction: Data from a randomized controlled trial designed primarily to test the effect of an antismoking socialization parenting program on child initiation of smoking were used to test the subsidiary hypothesis that providing antismoking socialization to children would lower the odds of relapse within a sub-sample of parents who had recently quit smoking. Methods: Over 13 months, 11 state Quitlines provided contact information for callers who were parents of 8- to 10-year-old children. Of 1604 parents enrolled in the trial, 689 (344 treatment; 345 control) had quit smoking cigarettes for at least 24 hours after calling a Quitline. Their data were used to test for group differences in 30-day abstinence measured using telephone interviews conducted 7 and 12 months post-baseline. Analyses of parents with complete follow-up data and intent-to-treat analyses incorporating parents lost to follow-up are presented. Results: Among 465 parents with complete follow-up data, treatment group parents had twice the odds of being abstinent 12 months post-baseline (adjusted OR = 2.01; P = .001) relative to controls. Intent-to-treat analysis with all 689 parents, in which those lost to follow-up were coded as having relapsed, showed a smaller though significant treatment effect on 30-day abstinence at 12 months (adjusted OR = 1.58; P = .017). Conclusions: This study is the first to observe that engaging parents who have quit smoking in antismoking socialization of children can lower their odds of relapse. Additional research is needed to replicate this finding and to identify the psychological mechanisms underlying the observed effect. Implications: There is a clear the need for research to develop new relapse prevention strategies. This study is the first to observe that engaging parents who have quit smoking in antismoking socialization of children can lower their odds of relapse. PMID:26416824

  18. Welfare, maternal work, and on-time childhood vaccination rates.

    PubMed

    Sohn, Min-Woong; Yoo, Joan; Oh, Elissa H; Amsden, Laura B; Holl, Jane L

    2011-12-01

    To examine effects of Temporary Assistance for Needy Families welfare cash assistance and maternal work requirements on "on-time" childhood vaccination rates. A stratified random sample of Illinois children from low-income families affected by welfare reform was monitored from 1997 to 2004. Medical records from pediatricians' offices and Medicaid claims data were used to identify the timeliness of 18 recommended vaccinations. Random-intercept logistic models were used to estimate on-time vaccine administration as a function of welfare receipt and maternal work with adjustment for characteristics of the children and mothers and time-varying covariates pertaining to the administration window for each recommended vaccine dose. Of all recommended vaccinations, 55.9% were administered on time. On-time vaccination rates were higher when families were receiving welfare than not (57.4% vs 52.8%). Children in families that either were receiving welfare or had working mothers were 1.7 to 2.1 times more likely to receive vaccinations on time compared with children in families that were not receiving welfare and did not have working mothers. When vaccine doses were stratified according to welfare status, maternal work was associated with decreased on-time vaccination rates (odds ratio: 0.73 [95% confidence interval: 0.59-0.90]) when families received welfare but increased on-time vaccination rates (odds ratio: 1.68 [95% confidence interval: 1.27-2.22]) when they did not receive welfare. These results indicate that maternal work requirements of Temporary Assistance for Needy Families had negative effects on timely administration of childhood vaccinations, although receipt of welfare itself was associated with increased on-time rates.

  19. Angiotensin-converting enzyme inhibitors in patients with coronary artery disease and absence of heart failure or left ventricular systolic dysfunction: an overview of long-term randomized controlled trials.

    PubMed

    Danchin, Nicolas; Cucherat, Michel; Thuillez, Christian; Durand, Eric; Kadri, Zena; Steg, Philippe G

    2006-04-10

    Results of randomized trials of angiotensin-converting enzyme inhibitors in patients with coronary artery disease (CAD) and preserved left ventricular function are conflicting. We undertook this study to determine whether long-term prescription of angiotensin-converting enzyme inhibitors decreases major cardiovascular events and mortality in patients who have CAD and no evidence of left ventricular systolic dysfunction. We searched MEDLINE, EMBASE, and IPA databases, the Cochrane Controlled Trials Register (1990-2004), and reports from scientific meetings (2003-2004), and we reviewed secondary sources. Search terms included angiotensin-converting enzyme inhibitors, coronary artery disease, randomi(s)zed controlled trials, clinical trials, and myocardial infarction. Eligible studies included randomized controlled trials in patients who had CAD and no heart failure or left ventricular dysfunction, with follow-up omicronf 2 years or longer. Of 1146 publications screened, 7 met our selection criteria and included a total of 33 960 patients followed up for a mean of 4.4 years. Five trials included only patients with documented CAD. One trial included patients with documented CAD (80%) or patients who had diabetes mellitus and 1 or more additional risk factors, and another trial included patients who had CAD, a history of transient ischemic attack, or intermittent claudication. Treatment with angiotensin-converting enzyme inhibitors decreased overall mortality (odds ratio, 0.86; 95% confidence interval, 0.79-0.93), cardiovascular mortality (odds ratio, 0.81; 95% confidence interval, 0.73-0.90), myocardial infarction (odds ratio, 0.82; 95% confidence interval, 0.75-0.89), and stroke (odds ratio, 0.77; 95% confidence interval, 0.66-0.88). Other end points, including resuscitation after cardiac arrest, myocardial revascularization, and hospitalization because of heart failure, were also reduced. Angiotensin-converting enzyme inhibitors reduce total mortality and major cardiovascular end points in patients who have CAD and no left ventricular systolic dysfunction or heart failure.

  20. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes.

    PubMed

    Li, Baoyue; Lingsma, Hester F; Steyerberg, Ewout W; Lesaffre, Emmanuel

    2011-05-23

    Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC.Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain.

  1. Past major depression and smoking cessation outcome: a systematic review and meta-analysis update

    PubMed Central

    Hitsman, Brian; Papandonatos, George D.; McChargue, Dennis E.; DeMott, Andrew; Herrera, María José; Spring, Bonnie; Borrelli, Belinda; Niaura, Raymond

    2012-01-01

    Aims To update our prior meta-analysis that showed past major depression (MD+) to be unrelated to smoking cessation outcome [Hitsman et al. J Consult Clin Psychol 2003; 71:657–63]. Methods Eligible trials included 14 from our original review and 28 identified through an updated systematic review (2000–2009). We coded for assessment of past MD, exclusion for recent MD episode (MDE; ≤6 months versus no exclusion), duration/modality of cognitive behavioral treatment (CBT; face-to-face versus self-help), and other factors. To minimize influence of experimental treatments that may selectively benefit MD+ smokers, we analyzed placebo/lowest intensity control arms only. Study-specific odds ratios (ORs) for the effect of past MD on short-term (≤3 months) and long-term (≥6 months) abstinence were estimated and combined using random effects. Two-way interaction models of past MD with study methodology and treatment factors were used to evaluate hypothesized moderators of the past MD-abstinence association. Results MD+ smokers had 17% lower odds of short-term abstinence (n=35, OR=0.83, 95% CI=0.72–0.95, p=0.009) and 19% lower odds of long-term abstinence (n=38, OR=0.81, 95% CI=0.67–0.97, p=0.023) than MD− smokers after excluding the sole study of varenicline because of its antidepressant properties. The association between past MD and abstinence was affected by methodological (recent MDE exclusion, type of MD assessment) and treatment (CBT modality) factors. Conclusions Past major depression has a modest adverse effect on abstinence during and after smoking cessation treatment. An increased focus on the identification of effective treatments or treatment adaptations that eliminate this disparity in smoking cessation for MD+ smokers is needed. PMID:23072580

  2. Enabling parents who smoke to prevent their children from initiating smoking: results from a 3-year intervention evaluation.

    PubMed

    Jackson, Christine; Dickinson, Denise

    2006-01-01

    To evaluate effects of a home-based antismoking socialization program on the initiation of smoking among children whose parents smoke. Three-year randomized controlled trial. Parents who were current smokers and had a child in the third grade who had not tried smoking were eligible; 873 parents-offspring pairs met these criteria, completed baseline interviews, and were randomly assigned to the intervention or control condition; 776 children (89%) completed an interview 3 years after baseline and were included in the study. During 3 months, the intervention group (n = 371) received 5 printed activity guides, parenting tip sheets, child newsletters, and incentives; this group also received a booster activity guide 1 year later. The control group (n = 405) received fact sheets about smoking. Initiation of smoking (first instance of puffing on a cigarette) was reported by 12% vs 19% of children in the intervention vs control groups. Logistic regression analysis indicated that children in the control condition had twice the odds of reporting initiation of smoking as children in the intervention condition (adjusted odds ratio, 2.16; P<.001), after adjusting for child sex, parent sex, parent race, parent educational achievement, child's best friends' smoking, parent smoking rate at baseline, and parent cessation status. Children in the pre-initiation phase of smoking who receive antismoking socialization from their parents are less likely to initiate smoking, even if their parents smoke.

  3. Efficacy of Flow-Diverting Devices for Cerebral Aneurysms: A Systematic Review and Meta-analysis.

    PubMed

    Zhou, Geng; Su, Ming; Zhu, Yue-Qi; Li, Ming-Hua

    2016-01-01

    To evaluate the efficacy of flow-diverting devices (FDDs) used in the treatment for intracranial aneurysms (IAs), we performed a meta-analysis of published literature on FDDs. A systematic electronic database search was conducted using MEDLINE, PubMed, Springer, and EBSCO for all accessible articles on FDDs published until December 2014. Abstracts, full-text manuscripts, and the reference lists of retrieved articles were analyzed. Random effects meta-analysis was used to pool the occlusion rate outcomes across studies. Fifty-nine studies containing efficacy data on 2263 patients with more than 2493 treated aneurysms were included in the analysis. The overall complete occlusion rate was 82.5% (95% CI, 78.8%-86%) across studies. The success rate of FDD implantation was 97.4% (95% CI, 95.4%-99.4%). The occlusion rate for anterior circulation aneurysms was 83.3% (95% CI, 71.2%-95.4%); with regard to complete occlusion, the odds ratio for anterior circulation aneurysms was significantly higher than that of posterior circulation IAs (odds ratio, 1.93; 95% CI, 1.00-3.73). FDDs have high technical success rates in the management of IAs. Additional studies on well-designed, multicenter, randomized controlled trials will be required to validate the findings of the present study and to identify the best therapeutic strategy for IAs depending on their size, location, and characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

    PubMed

    Borland, Ron; Balmford, James; Benda, Peter

    2013-03-01

    To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

  5. Citicoline for Acute Ischemic Stroke: A Systematic Review and Formal Meta-analysis of Randomized, Double-Blind, and Placebo-Controlled Trials.

    PubMed

    Secades, Julio J; Alvarez-Sabín, José; Castillo, José; Díez-Tejedor, Exuperio; Martínez-Vila, Eduardo; Ríos, José; Oudovenko, Natalia

    2016-08-01

    Citicoline is a drug approved for the treatment of acute ischemic stroke. Although evidence of its efficacy has been reported, recently published results of a large placebo-controlled clinical trial did not show differences. This study aims to assess whether starting citicoline treatment within 14 days after stroke onset improves the outcome in patients with acute ischemic stroke, as compared with placebo. A systematic search was performed to identify all published, unconfounded, randomized, double-blind, and placebo-controlled clinical trials of citicoline in acute ischemic stroke. Ten randomized clinical trials met our inclusion criteria. The administration of citicoline was associated with a significant higher rate of independence, independently of the method of evaluation used (odds ratio [OR] 1.56, 95% confidence interval [CI] = 1.12-2.16 under random effects; OR 1.20, 95% CI = 1.06-1.36 under fixed effects). After studying the cumulative meta-analysis, and with the results obtained with the subgroup of patients who were not treated with recombinant tissue plasminogen activator (rtPA) (OR 1.63, 95% CI = 1.18-2.24 under random effects; OR 1.42, 95% CI = 1.22-1.66 under fixed effects), our hypothesis of dilution of the effect of citicoline was confirmed. When we analyzed the effect of citicoline in patients who were not treated with rtPA and were receiving the highest dose of citicoline started in the first 24 hours after onset, based on more recent trials, there was no heterogeneity, and the size of the effect has an OR of 1.27 (95% CI = 1.05-1.53). This systematic review supports some benefits of citicoline in the treatment of acute ischemic stroke. But, on top of the best treatment available (rtPA), citicoline offers a limited benefit. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  6. The risk of traumatic lumbar punctures in children with acute lymphoblastic leukaemia.

    PubMed

    Shaikh, Furqan; Voicu, Laura; Tole, Soumitra; To, Teresa; Doria, Andrea S; Sung, Lillian; Alexander, Sarah

    2014-05-01

    Traumatic lumbar punctures with blasts (TLP+) in children with acute lymphoblastic leukaemia (ALL) obscure central nervous system status and are associated with a poorer event-free survival (EFS). We conducted a retrospective cohort study of all lumbar punctures (LPs) for children with ALL diagnosed at our institution from 2005 to 2009. We utilised random-effects and fixed-effects repeated-measures logistic regression analyses to identify risk factors for TLPs. Fixed-effects models use each patient as his or her own control. We used survival analysis to describe outcomes after a TLP+. 264 children underwent 5267 evaluable lumbar punctures (LPs), of which 944 (17.9%) were traumatic. In the multivariable random-effects model, variables significantly associated with TLPs were age <1year (odds ratio (OR) 3.46, 95% confidence interval (CI) 2.06-5.81) or age ⩾10years (OR 2.00, CI 1.66-2.40); body mass index percentile ⩾95 (OR 1.44, CI 1.19-1.75); platelet count <100×10(3)/μL (OR 1.49, CI 1.08-20.7); fewer days since previous LP (OR 5.13, CI 2.34-11.25 for ⩾16days versus 0-3days); and a preceding TLP (OR 1.43, CI 1.19-1.73). In the fixed-effects model, image-guidance reduced the odds of TLP (OR 0.55, CI 0.32-0.95). The 5-year EFS (±SE) for children with TLP+ (77±8%) was significantly lower than for children with CNS1 status (93±2%; p=0.002). The frequency of TLP remains high. Consistent with previous studies, a TLP+ at diagnosis was associated with a poorer EFS. These risk factors can allow identifying interventions to reduce TLPs and directing interventions to those at highest risk. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. Costs and effects of a state-wide health promotion program in primary schools in Germany - the Baden-Württemberg Study: A cluster-randomized, controlled trial.

    PubMed

    Kesztyüs, Dorothea; Lauer, Romy; Kesztyüs, Tibor; Kilian, Reinhold; Steinacker, Jürgen M

    2017-01-01

    To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program "Join the Healthy Boat" in primary schools in Germany. Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years) were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR) ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER) to identify the costs per case of averted abdominal obesity were calculated. The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]). The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group. This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases. German Clinical Trials Register (DRKS), Freiburg University, Germany, DRKS-ID: DRKS00000494.

  8. Costs and effects of a state-wide health promotion program in primary schools in Germany – the Baden-Württemberg Study: A cluster-randomized, controlled trial

    PubMed Central

    Kesztyüs, Tibor; Kilian, Reinhold; Steinacker, Jürgen M

    2017-01-01

    Aim To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program “Join the Healthy Boat” in primary schools in Germany. Methods Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years) were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR) ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER) to identify the costs per case of averted abdominal obesity were calculated. Results The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]). The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group. Conclusion This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases. Trial registration German Clinical Trials Register (DRKS), Freiburg University, Germany, DRKS-ID: DRKS00000494. PMID:28222101

  9. Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes: a randomized controlled trial

    PubMed Central

    Wang, Philip S.; Simon, Gregory E.; Avorn, Jerry; Azocar, Francisca; Ludman, Evette J.; McCulloch, Joyce; Petukhova, Maria Z.; Kessler, Ronald C.

    2010-01-01

    Context Although guideline-concordant depression treatment is clearly effective, treatment often falls short of evidence-based recommendations. Organized depression care programs significantly improve treatment quality, but employer-purchasers have been slow to demand these programs based on lack of evidence for cost-effectiveness from their perspective. Objective To evaluate the effects of a depression outreach-treatment program on workplace outcomes of concern to employers. Design Randomized controlled trial with allocation concealment and blinded assessment of depression severity and work performance at 6 and 12 months. Setting and Participants Two-stage screening of employees covered by a managed behavioral health plan identified 604 with clinically significant depression (excluding those with lifetime bipolar disorder, substance disorder, recent mental health specialty care, or suicidality). Intervention A telephonic outreach and care management program encouraged workers to enter outpatient treatment (psychotherapy and/or antidepressant medication), monitored treatment quality-continuity, and attempted to improve treatment by giving recommendations to providers. Participants reluctant to enter treatment were offered a structured telephone cognitive-behavioral psychotherapy. Main Outcome Measures Depression severity (Quick Inventory of Depressive Symptomatology, QIDS-SR) and work performance (WHO Health and Productivity Questionnaire, HPQ, a validated self-report instrument assessing job retention, time missed from work, work performance, and critical workplace incidents). Results Combining data across 6-month and 12-month assessments, the intervention group had significantly lower QIDS-SR scores (1.4 relative-odds of recovery), significantly higher job retention (1.7 relative-odds), and significantly more hours worked among the employed (equivalent to an annualized effect of approximately 2.5 weeks of work) than usual care subjects. Conclusions A systematic program to identify depression and promote effective treatment significantly improves not only clinical outcomes but also workplace outcomes. The financial value of the latter to employers in terms of recovered hiring-training and salary costs suggests that many employers would experience a positive return on investment from outreach and enhanced treatment of depressed workers. PMID:17895456

  10. Depressive symptoms negate the beneficial effects of physical activity on mortality risk.

    PubMed

    Lee, Pai-Lin

    2013-01-01

    The aim of this study is to: (1) compare the association between various levels of physical activity (PA) and mortality; and (2) examine the potential modifying effect of depressive symptoms on the PA-mortality associations. Previous large scale randomized studies rarely assess the association in conjunction with modifying effects of depressive symptoms. In this study, participants consisted of 624 (mean age = 77.35 years) non-institutionalized elderly from the Americans' Changing Lives Longitudinal Study. Depression was measured using the Center for Epidemiological Studies' Depression Scale. Participants in gardening, walking, and sports were first classified into four PA frequency levels, "never," "rarely," "sometimes," and "often." Those who self-reported "often" engaged in activities of gardening and walking and had reduced odds of mortality of 77% and 83%, adjusted odds ratio (ORadj) = .23 and .17, 95% confidence interval (CI) = .09-.59 and.07-.41 when compared to those who reported "never." However, mortality risk was not linked to sports activity. The modifying effects of depressive symptoms on PA (depressive symptoms x PA) were then tested, PA was not associated with increased risk for mortality for gardening (parameter estimates, PE = -.03 +/- .62, p = .958), and for walking (PE = .04 +/- .57, p = .948). Elderly people who engaged in gardening and walking might have protection effects on later risk of mortality. Depressive symptoms showed negative modifying effects that prevent PA predicting later mortality.

  11. Transient Elastography vs. Aspartate Aminotransferase to Platelet Ratio Index in Hepatitis C: A Meta-Analysis.

    PubMed

    Mattos, A Z; Mattos, A A

    Many different non-invasive methods have been studied with the purpose of staging liver fibrosis. The objective of this study was verifying if transient elastography is superior to aspartate aminotransferase to platelet ratio index for staging fibrosis in patients with chronic hepatitis C. A systematic review with meta-analysis of studies which evaluated both non-invasive tests and used biopsy as the reference standard was performed. A random-effects model was used, anticipating heterogeneity among studies. Diagnostic odds ratio was the main effect measure, and summary receiver operating characteristic curves were created. A sensitivity analysis was planned, in which the meta-analysis would be repeated excluding each study at a time. Eight studies were included in the meta-analysis. Regarding the prediction of significant fibrosis, transient elastography and aspartate aminotransferase to platelet ratio index had diagnostic odds ratios of 11.70 (95% confidence interval = 7.13-19.21) and 8.56 (95% confidence interval = 4.90-14.94) respectively. Concerning the prediction of cirrhosis, transient elastography and aspartate aminotransferase to platelet ratio index had diagnostic odds ratios of 66.49 (95% confidence interval = 23.71-186.48) and 7.47 (95% confidence interval = 4.88-11.43) respectively. In conclusion, there was no evidence of significant superiority of transient elastography over aspartate aminotransferase to platelet ratio index regarding the prediction of significant fibrosis, but the former proved to be better than the latter concerning prediction of cirrhosis.

  12. Meta analysis of angiotensin-converting enzyme I/D polymorphism as a risk factor for preeclampsia in Chinese women.

    PubMed

    Zhong, W G; Wang, Y; Zhu, H; Zhao, X

    2012-08-13

    Preeclampsia affects 3-8% of pregnancies and is a major cause of maternal and perinatal morbidity and mortality worldwide. Inappropriate activation of the renin-angiotensin system may play a role in the development of preeclampsia. An insertion/deletion polymorphism in the angiotensin-converting enzyme gene (ACE-I/D) has been associated with differences in ACE activity. However, there are controversies in reports on the association of ACE-I/D with preeclampsia. Data were analyzed using Review Manager Version 5.0 and a random effects model was applied irrespective of between studies heterogeneity, which was evaluated via sensitivity and subgroup analyses. Publication bias was evaluated using the fail-safe number. A systematic search was performed based on published case control studies up to October 1, 2011, and 11 studies were included, involving 800 patients and 949 controls. Significant association of the ACE D allele with increase risk of preeclampsia was found (odds ratio = 1.93, 95% confidence interval = 1.19-3.12; P = 0.008). Sensitivity analysis showed that no individual study had an undue influence on the summary odds ratios for all contrasts. An analysis stratified by study size showed an attenuated odds ratio towards a null effect as study size increased. Based on our meta-analysis, we suggest that the D allele of the ACE gene is related with increased risk for preeclampsia in the Chinese population. Considering the potential existence of small study bias, further research should be performed with a larger dataset.

  13. Clinical and Molecular Epidemiology of Extended-Spectrum Beta-Lactamase-Producing Klebsiella spp.: A Systematic Review and Meta-Analyses

    PubMed Central

    Hendrik, Tirza C.; Voor in ‘t holt, Anne F.; Vos, Margreet C.

    2015-01-01

    Healthcare-related infections caused by extended-spectrum beta-lactamase (ESBL)-producing Klebsiella spp. are of major concern. To control transmission, deep understanding of the transmission mechanisms is needed. This systematic review aimed to identify risk factors and sources, clonal relatedness using molecular techniques, and the most effective control strategies for ESBL-producing Klebsiella spp. A systematic search of PubMed, Embase, and Outbreak Database was performed. We identified 2771 articles from November 25th, 1960 until April 7th, 2014 of which 148 were included in the systematic review and 23 in a random-effects meta-analysis study. The random-effects meta-analyses showed that underlying disease or condition (odds ratio [OR] = 6.25; 95% confidence interval [CI] = 2.85 to 13.66) generated the highest pooled estimate. ESBL-producing Klebsiella spp. were spread through person-to-person contact and via sources in the environment; we identified both monoclonal and polyclonal presence. Multi-faceted interventions are needed to prevent transmission of ESBL-producing Klebsiella spp. PMID:26485570

  14. New oral anticoagulants in patients with cancer: current state of evidence.

    PubMed

    Sardar, Partha; Chatterjee, Saurav; Herzog, Eyal; Pekler, Gerald; Mushiyev, Savi; Pastori, Luciano J; Visco, Ferdinand; Aronow, Wilbert S

    2015-01-01

    Effectiveness of new oral anticoagulants (NOAC) in patients with cancer is not clearly defined. There remain concerns of doubtful benefit and chances of potential harm with newer agents. In this meta-analysis, we evaluated the efficacy and safety of NOAC in patients with cancer. PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 01, 2001 through February 28, 2013. Randomized controlled trials reporting efficacy and safety data of NOACs (rivaroxaban, dabigatran, and apixaban) with control (low-molecular-weight heparin/vitamin K antagonists/placebo) for patients with cancer were included. Primary efficacy outcome was venous thromboembolism (VTE) or VTE-related death, and primary safety outcome was clinically relevant bleeding. We used random-effects models. Six trials randomized 19,832 patients, and 1197 patients had cancer. Risk of VTE or VTE-related death was not significantly different with NOAC versus control [odds ratio (OR), 0.80; 95% confidence interval (CI), 0.39-1.65] in patients with cancer. Separate analysis for individual effects showed similar results for rivaroxaban (OR, 1.08; 95% CI, 0.60-1.94) and dabigatran (OR, 0.91; 95% CI, 0.21-3.91). Clinically relevant bleeding was not higher with NOAC compared with control (OR, 1.49; 95% CI, 0.82-2.71); individual effect of rivaroxaban showed similar results. No statistically significant difference of efficacy and safety with NOAC was found between patients with and without cancer. Rivaroxaban might be equally effective and safe as vitamin K antagonist in patients with cancer. Dabigatran is as effective as comparator; however, safety profile of dabigatran is unknown. Randomized trials of new anticoagulants specific to the cancer population are necessary, and NOAC also need to be evaluated against low-molecular-weight heparin.

  15. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial.

    PubMed

    Kahler, Christopher W; Spillane, Nichea S; Day, Anne M; Cioe, Patricia A; Parks, Acacia; Leventhal, Adam M; Brown, Richard A

    2015-11-01

    Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). This trial suggests substantial promise for incorporating PPT into smoking cessation treatment. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  16. A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related Emergency Department Visits.

    PubMed

    Neven, Darin; Paulozzi, Leonard; Howell, Donelle; McPherson, Sterling; Murphy, Sean M; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, John

    2016-11-01

    Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users. We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively. This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  17. Family factors affect clinician attitudes in pediatric end-of-life decision making: a randomized vignette study.

    PubMed

    Ruppe, Michael D; Feudtner, Chris; Hexem, Kari R; Morrison, Wynne E

    2013-05-01

    Conflicts between families and clinicians in pediatric end-of-life (EOL) care cause distress for providers, dissatisfaction for patients' families, and potential suffering for terminally ill children. We hypothesized that family factors might influence clinician decision making in these circumstances. We presented vignettes concerning difficult EOL decision making, randomized for religious objection to therapy withdrawal and perceived level of family involvement, to clinicians working in three Children's Hospital intensive care units. Additionally, attitudes about EOL care were assessed. Three hundred sixty-four respondents completed the questionnaire, for an overall response rate of 54%. Respondents receiving the "involved family" vignette were more likely to agree to continue medical care indefinitely (P<0.0005). Respondents were marginally more likely to pursue a court-appointed guardian for those patients whose families had nonreligious objections to withdrawal (P=0.05). Respondents who thought that a fear of being sued affected decisions were less likely to pursue unilateral withdrawal (odds ratio 0.8, 95% CI=0.6-0.9). Those who felt personal distress as a result of difficult EOL decision making, thought they often provided "futile" care, or those who felt EOL care was effectively addressed at the institution were less likely to want to defer to the parents' wishes (range of odds ratios 0.7-1). In this randomized vignette study, we have shown that family factors, particularly how involved a family seems to be in a child's life, affect what clinicians think is ethically appropriate in challenging EOL cases. Knowledge of how a family's degree of involvement may affect clinicians should be helpful to the clinical ethics consultants and offer some degree of insight to the clinicians themselves. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  18. Systemic hypothermia to prevent radiocontrast nephropathy (from the COOL-RCN Randomized Trial).

    PubMed

    Stone, Gregg W; Vora, Kishor; Schindler, John; Diaz, Claro; Mann, Tift; Dangas, George; Best, Patricia; Cutlip, Donald E

    2011-09-01

    Radiocontrast nephropathy (RCN) develops in a substantial proportion of patients with chronic kidney disease (CKD) after invasive cardiology procedures and is strongly associated with subsequent mortality and adverse outcomes. We sought to determine whether systemic hypothermia is effective in preventing RCN in patients with CKD. Patients at risk for RCN (baseline estimated creatinine clearance 20 to 50 ml/min) undergoing cardiac catheterization with iodinated contrast ≥50 ml were randomized 1:1 to hydration (control arm) versus hydration plus establishment of systemic hypothermia (33°C to 34°C) before first contrast injection and for 3 hours after the procedure. Serum creatinine levels at baseline, 24 hours, 48 hours, and 72 to 96 hours were measured at a central core laboratory. The primary efficacy end point was development of RCN, defined as an increase in serum creatinine by ≥25% from baseline. The primary safety end point was 30-day composite rate of adverse events consisting of death, myocardial infarction, dialysis, ventricular fibrillation, venous complication requiring surgery, major bleeding requiring transfusion ≥2 U, or rehospitalization. In total 128 evaluable patients (mean creatinine clearance 36.6 ml/min) were prospectively randomized at 25 medical centers. RCN developed in 18.6% of normothermic patients and in 22.4% of hypothermic patients (odds ratio 1.27, 95% confidence interval 0.53 to 3.00, p = 0.59). The primary 30-day safety end point occurred in 37.1% versus 37.9% of normothermic and hypothermic patients, respectively (odds ratio 0.97, 95% confidence interval 0.47 to 1.98, p = 0.93). In conclusion, in patients with CKD undergoing invasive cardiology procedures, systemic hypothermia is safe but is unlikely to prevent RCN. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial.

    PubMed

    Foxman, Betsy; Cronenwett, Anna E W; Spino, Cathie; Berger, Mitchell B; Morgan, Daniel M

    2015-08-01

    The risk of urinary tract infection (UTI) among women undergoing elective gynecological surgery during which a catheter is placed is high: 10-64% following catheter removal. We conducted the first randomized, double-blind, placebo-controlled trial of the therapeutic efficacy of cranberry juice capsules in preventing UTI after surgery. We recruited patients from a single hospital between August 2011 and January 2013. Eligible participants were undergoing elective gynecological surgery that did not involve a fistula repair or vaginal mesh removal. One hundred sixty patients were randomized and received 2 cranberry juice capsules 2 times a day, equivalent to 2 8 ounce servings of cranberry juice, for 6 weeks after surgery or matching placebo. The primary endpoint was the proportion of participants who experienced clinically diagnosed and treated UTI with or without positive urine culture. Kaplan-Meier plots and log rank tests compared the 2 treatment groups. The occurrence of UTI was significantly lower in the cranberry treatment group compared with the placebo group (15 of 80 [19%] vs 30 of 80 [38%]; odds ratio, 0.38; 95% confidence interval, 0.19-0.79; P = .008). After adjustment for known confounders, including the frequency of intermittent self-catheterization in the postoperative period, the protective effects of cranberry remained (odds ratio, 0.42; 95% confidence interval, 0.18-0.94). There were no treatment differences in the incidence of adverse events, including gastrointestinal upset (56% vs 61% for cranberry vs placebo). Among women undergoing elective benign gynecological surgery involving urinary catheterization, the use of cranberry extract capsules during the postoperative period reduced the rate of UTI by half. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes’ Effects on Moms (GEM) Cluster Randomized Controlled Trial

    PubMed Central

    Hedderson, Monique M.; Brown, Susan D.; Albright, Cheryl L.; Ehrlich, Samantha F.; Tsai, Ai-Lin; Caan, Bette J.; Sternfeld, Barbara; Gordon, Nancy P.; Schmittdiel, Julie A.; Gunderson, Erica P.; Mevi, Ashley A.; Herman, William H.; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P.

    2016-01-01

    OBJECTIVE To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention. RESEARCH DESIGN AND METHODS This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change. RESULTS On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). CONCLUSIONS A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. PMID:26657945

  1. Does Stress Result in You Exercising Less? Or Does Exercising Result in You Being Less Stressed? Or is it Both?

    PubMed Central

    Burg, Matthew M.; Schwartz, Joseph E.; Kronish, Ian M.; Diaz, Keith M.; Alcantara, Carmela; Duer-Hefele, Joan; Davidson, Karina W.

    2017-01-01

    Background Psychosocial stress contributes to heart disease in part by adversely affecting maintenance of health behaviors, while exercise can reduce stress. Assessing the bi-directional relationship between stress and exercise has been limited by lack of real-time data, and theoretical and statistical models. This lack may hinder efforts to promote exercise maintenance. Purpose We test the bi-directional relationship between stress and exercise using real-time data for the average person, and the variability – individual differences – in this relationship. Methods A single cohort randomized controlled experiment. Healthy young adults (n=79) who reported only intermittent exercise, completed 12 months of stress monitoring by ecological momentary assessment (at the beginning of, end of, and during the day), and continuous activity monitoring by Fitbit. A random coefficients linear mixed model was used to predict end-of-day stress from the occurrence/non-occurrence of exercise that day; a logistic mixed model was used to predict the occurrence/non-occurrence of exercise from ratings of anticipated stress. Separate regression analyses were also performed for each participant. Sensitivity analysis tested all models, restricted to the first 180 days of observation (prior to randomization). Results We found a significant average inverse (i.e., negative) effect of exercise on stress and of stress on exercise. There was significant between-person variability. Of N=69, exercise was associated with a stress reduction for 15, a stress increase for 2, and no change for the remainder. We also found that an increase in anticipated stress reported the previous night or that morning was associated with a significant 20–22% decrease (OR=0.78–0.80) in the odds of exercising that day. Of N=69, this increase in stress reduced the likelihood of exercise for 17, increased the odds for 1, and had no effect for the remainder. We were unable to identify psychosocial factors that moderate the individual differences in these effects. Conclusions The relationship of stress to exercise can be uni- or bi-directional, and varies from person to person. A precision medicine approach may improve exercise uptake. PMID:28290065

  2. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

    PubMed

    Ferrara, Assiamira; Hedderson, Monique M; Brown, Susan D; Albright, Cheryl L; Ehrlich, Samantha F; Tsai, Ai-Lin; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Herman, William H; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P

    2016-01-01

    To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m(2) or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m(2); and pregravid to postpartum weight change. On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference -0.64 kg [95% CI -1.13, -0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  3. Improving Breast Cancer Surgical Treatment Decision Making: The iCanDecide Randomized Clinical Trial.

    PubMed

    Hawley, Sarah T; Li, Yun; An, Lawrence C; Resnicow, Kenneth; Janz, Nancy K; Sabel, Michael S; Ward, Kevin C; Fagerlin, Angela; Morrow, Monica; Jagsi, Reshma; Hofer, Timothy P; Katz, Steven J

    2018-03-01

    Purpose This study was conducted to determine the effect of iCanDecide, an interactive and tailored breast cancer treatment decision tool, on the rate of high-quality patient decisions-both informed and values concordant-regarding locoregional breast cancer treatment and on patient appraisal of decision making. Methods We conducted a randomized clinical trial of newly diagnosed patients with early-stage breast cancer making locoregional treatment decisions. From 22 surgical practices, 537 patients were recruited and randomly assigned online to the iCanDecide interactive and tailored Web site (intervention) or the iCanDecide static Web site (control). Participants completed a baseline survey and were mailed a follow-up survey 4 to 5 weeks after enrollment to assess the primary outcome of a high-quality decision, which consisted of two components, high knowledge and values-concordant treatment, and secondary outcomes (decision preparation, deliberation, and subjective decision quality). Results Patients in the intervention arm had higher odds of making a high-quality decision than did those in the control arm (odds ratio, 2.00; 95% CI, 1.37 to 2.92; P = .0004), which was driven primarily by differences in the rates of high knowledge between groups. The majority of patients in both arms made values-concordant treatment decisions (78.6% in the intervention arm and 81.4% in the control arm). More patients in the intervention arm had high decision preparation (estimate, 0.18; 95% CI, 0.02 to 0.34; P = .027), but there were no significant differences in the other decision appraisal outcomes. The effect of the intervention was similar for women who were leaning strongly toward a treatment option at enrollment compared with those who were not. Conclusion The tailored and interactive iCanDecide Web site, which focused on knowledge building and values clarification, positively affected high-quality decisions largely by improving knowledge compared with static online information. To be effective, future patient-facing decision tools should be integrated into the clinical workflow to improve decision making.

  4. Effects of occupational role conflict and emotional demands on subsequent psychological distress: a 3-year follow-up study of the general working population in Norway.

    PubMed

    Johannessen, Håkon A; Tynes, Tore; Sterud, Tom

    2013-06-01

    To examine the impact of occupational role conflict and emotional demands on subsequent psychological distress. A randomly drawn cohort from the general Norwegian working-age population was followed up for 3 years (n = 12,550; response rate = 67%). Eligible respondents were in paid work during the reference week in 2006 and 2009 or temporarily absent from such work (n = 6,745; response rate = 68%). In the fully adjusted model, both high role conflict (odds ratios = 1.53; 95% CI = 1.15 to 2.03) and high emotional demands (odds ratios = 1.38; 95% CI = 1.13 to 1.69) were significant predictors of psychological distress. Additional significant predictors were low job control, bullying/harassment, and job insecurity (P < 0.05). Considering all of the evaluated work-related factors, role conflict and emotional demands contributed the most to the population risk of developing psychological distress.

  5. [Is Mapuche ethnicity a risk factor for hip fracture in aged?].

    PubMed

    Sapunar, Jorge; Bravo, Paulina; Schneider, Hermann; Jiménez, Marcela

    2003-10-01

    Ethnic factors are involved in the risk for osteoporosis and hip fracture. To assess the effect of Mapuche ethnicity on the risk of hip fracture. A case control study. Cases were subjects over 55 years of age admitted, during one year, for hip fracture not associated to major trauma or tumors. Controls were randomly chosen from other hospital services and paired for age with cases. The magnitude of the association between ethnicity and hip fracture was expressed as odds ratio in a logistic regression model. In the study period, 156 cases with hip fracture were admitted. The proportion of subjects with Mapuche origin was significantly lower among cases than controls (11.8 and 26.5% respectively, p < 0.001). In the logistic regression model, Mapuche ethnicity was associated with hip fracture with an odds radio of 0.14 (p = 0.03, 95% CI 0.03-0.8). In this sample, Mapuche ethnicity is a protective factor for hip fracture.

  6. Adaptation to Temporally Fluctuating Environments by the Evolution of Maternal Effects.

    PubMed

    Dey, Snigdhadip; Proulx, Stephen R; Teotónio, Henrique

    2016-02-01

    All organisms live in temporally fluctuating environments. Theory predicts that the evolution of deterministic maternal effects (i.e., anticipatory maternal effects or transgenerational phenotypic plasticity) underlies adaptation to environments that fluctuate in a predictably alternating fashion over maternal-offspring generations. In contrast, randomizing maternal effects (i.e., diversifying and conservative bet-hedging), are expected to evolve in response to unpredictably fluctuating environments. Although maternal effects are common, evidence for their adaptive significance is equivocal since they can easily evolve as a correlated response to maternal selection and may or may not increase the future fitness of offspring. Using the hermaphroditic nematode Caenorhabditis elegans, we here show that the experimental evolution of maternal glycogen provisioning underlies adaptation to a fluctuating normoxia-anoxia hatching environment by increasing embryo survival under anoxia. In strictly alternating environments, we found that hermaphrodites evolved the ability to increase embryo glycogen provisioning when they experienced normoxia and to decrease embryo glycogen provisioning when they experienced anoxia. At odds with existing theory, however, populations facing irregularly fluctuating normoxia-anoxia hatching environments failed to evolve randomizing maternal effects. Instead, adaptation in these populations may have occurred through the evolution of fitness effects that percolate over multiple generations, as they maintained considerably high expected growth rates during experimental evolution despite evolving reduced fecundity and reduced embryo survival under one or two generations of anoxia. We develop theoretical models that explain why adaptation to a wide range of patterns of environmental fluctuations hinges on the existence of deterministic maternal effects, and that such deterministic maternal effects are more likely to contribute to adaptation than randomizing maternal effects.

  7. Adaptation to Temporally Fluctuating Environments by the Evolution of Maternal Effects

    PubMed Central

    Dey, Snigdhadip; Proulx, Stephen R.; Teotónio, Henrique

    2016-01-01

    All organisms live in temporally fluctuating environments. Theory predicts that the evolution of deterministic maternal effects (i.e., anticipatory maternal effects or transgenerational phenotypic plasticity) underlies adaptation to environments that fluctuate in a predictably alternating fashion over maternal-offspring generations. In contrast, randomizing maternal effects (i.e., diversifying and conservative bet-hedging), are expected to evolve in response to unpredictably fluctuating environments. Although maternal effects are common, evidence for their adaptive significance is equivocal since they can easily evolve as a correlated response to maternal selection and may or may not increase the future fitness of offspring. Using the hermaphroditic nematode Caenorhabditis elegans, we here show that the experimental evolution of maternal glycogen provisioning underlies adaptation to a fluctuating normoxia–anoxia hatching environment by increasing embryo survival under anoxia. In strictly alternating environments, we found that hermaphrodites evolved the ability to increase embryo glycogen provisioning when they experienced normoxia and to decrease embryo glycogen provisioning when they experienced anoxia. At odds with existing theory, however, populations facing irregularly fluctuating normoxia–anoxia hatching environments failed to evolve randomizing maternal effects. Instead, adaptation in these populations may have occurred through the evolution of fitness effects that percolate over multiple generations, as they maintained considerably high expected growth rates during experimental evolution despite evolving reduced fecundity and reduced embryo survival under one or two generations of anoxia. We develop theoretical models that explain why adaptation to a wide range of patterns of environmental fluctuations hinges on the existence of deterministic maternal effects, and that such deterministic maternal effects are more likely to contribute to adaptation than randomizing maternal effects. PMID:26910440

  8. A cross-sectional study of reproductive performance of smallholder dairy cows in coastal Tanzania.

    PubMed

    Swai, E S; Bryant, M J; Karimuribo, E D; French, N P; Ogden, N H; Fitzpatrick, J L; Kambarage, D M

    2005-08-01

    A retrospective cross-sectional study was conducted on 200 randomly selected smallholder farms from a mixed dairy farming system in Tanga, Tanzania, between January and April 1999. We estimated the frequency and determinants of long calving interval (LCI), retention of fetal membrane (RFM), dystocia, and abortion in smallholder crossbred cattle and explored birth trends. The mean calving interval was 500 days and birth rate was 65 per 100 cow-years. Dystocia was reported to affect 58% of calvings, and 17.2% of animals suffered RFM. Using mixed effect models, the variables associated with LCI, RFM and dystocia were breed, level of exotic blood and condition score. Zebu breeding was associated with LCI (odds ratio (OR) = 2.3, p = 0.041) and Friesian breeding with lower odds for RF (OR = 0.26, p = 0.020). Animals with higher levels of exotic blood had lower odds for evidence of dystocia (OR = 0.45, p = 0.021). Evidence of dystocia was significantly associated with poor condition score (p = -1.10, p = 0.001). Our observations suggest that LCIs are common in smallholder dairy farms in this region and a likely source of economic loss. Dystocia, RFM, poor condition score and mineral deficiency were common problems and were possibly linked to LCI.

  9. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial

    PubMed Central

    2011-01-01

    Background The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. Methods This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. Results At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. ClinicalTrials.gov Identifier NCT00125905. PMID:21605389

  10. The comparison between intradermal injection of abobotulinumtoxinA and normal saline for face-lifting: a split-face randomized controlled trial.

    PubMed

    Wanitphakdeedecha, Rungsima; Ungaksornpairote, Chanida; Kaewkes, Arisa; Rojanavanich, Viboon; Phothong, Weeranut; Manuskiatti, Woraphong

    2016-12-01

    Botulinum toxin type A (BTA) has been approved for the treatment of strabismus, blepharospasm, muscle spasm, cervical dystonia, pain syndrome, glabella wrinkles, and severe primary axillary hyperhidrosis. Intradermal injection of BTA has been used off-label by many clinicians for the purpose of face-lifting effect. Few studies on onabotulinumtoxinA (ONA) demonstrated no clinical efficacy on face-lifting effect when comparing to normal saline solution (NSS). So far, there is no split-face comparison study on face-lifting effect of abobotulinumtoxinA (ABO). To determine the face-lifting effect of ABO intradermal injection and NSS. Twenty-two subjects with symmetrical faces on both facial expression and expressionless were randomly injected with ABO at 1:7 cc dilution (500 unit or one vial in 7 cc of NSS) on one side and NSS on the other side using intradermal injection technique. Standardized photographic documentation was obtained at baseline, and at 2 weeks after treatment. The face-lifting effect was graded by two blinded dermatologists using photographic comparison and rated by the patients. Side effects were also recorded at the end of the study. Face-lifting effect was demonstrated in 40.9% and 4.5% of patients with ABO and NSS, respectively. There was a statistically significant difference in face-lifting effect when comparing between ABO and NSS (P = 0.021). The face-lifting was reported in 50.0% of patients receiving ABO injection. The patients with oval-face shape tended to respond better with ABO (P = 0.046). The odd of face-lifting effect for patients aged younger than 32 was higher than patients aged older than 32 with the odds ratio of 7.9 and 95% confidence interval of 1.1-56.1. Facial asymmetry was found in 22.7% of subjects. This study demonstrated the face-lifting effect of ABO intradermal injection. Patients with oval-face shape and aged younger than 32 tended to respond better. Therefore, patient selection should be emphasized to improve efficacy of this technique. © 2016 The Authors. Journal of Cosmetic Dermatology Published by Wiley Periodicals, Inc.

  11. Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction

    PubMed Central

    Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J.; Tornyos, Adrienn

    2014-01-01

    Introduction Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Material and methods Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Results Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38–0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43–0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52–0.86), p = 0.002 respectively). Conclusions Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI. PMID:24904651

  12. Meta-analysis of randomized trials on access site selection for percutaneous coronary intervention in ST-segment elevation myocardial infarction.

    PubMed

    Komócsi, András; Aradi, Dániel; Kehl, Dániel; Ungi, Imre; Thury, Attila; Pintér, Tünde; Di Nicolantonio, James J; Tornyos, Adrienn; Vorobcsuk, András

    2014-05-12

    Superior outcomes with transradial (TRPCI) versus transfemoral coronary intervention (TFPCI) in the setting of acute ST-segment elevation myocardial infarction (STEMI) have been suggested by earlier studies. However, this effect was not evident in randomized controlled trials (RCTs), suggesting a possible allocation bias in observational studies. Since important studies with heterogeneous results regarding mortality have been published recently, we aimed to perform an updated review and meta-analysis on the safety and efficacy of TRPCI compared to TFPCI in the setting of STEMI. Electronic databases were searched for relevant studies from January 1993 to November 2012. Outcome parameters of RCTs were pooled with the DerSimonian-Laird random-effects model. Twelve RCTs involving 5,124 patients were identified. According to the pooled analysis, TRPCI was associated with a significant reduction in major bleeding (odds ratio (OR): 0.52 (95% confidence interval (CI) 0.38-0.71, p < 0.0001)). The risk of mortality and major adverse events was significantly lower after TRPCI (OR = 0.58 (95% CI: 0.43-0.79), p = 0.0005 and OR = 0.67 (95% CI: 0.52-0.86), p = 0.002 respectively). Robust data from randomized clinical studies indicate that TRPCI reduces both ischemic and bleeding complications in STEMI. These findings support the preferential use of radial access for primary PCI.

  13. Voluntary counseling and testing (VCT) for changing HIV-related risk behavior in developing countries.

    PubMed

    Fonner, Virginia A; Denison, Julie; Kennedy, Caitlin E; O'Reilly, Kevin; Sweat, Michael

    2012-09-12

    Voluntary counseling and testing (VCT) continues to play a critical role in HIV prevention, care and treatment. In recent years, different modalities of VCT have been implemented, including clinic-, mobile- and home-based testing and counseling. This review assesses the effects of all VCT types on HIV-related risk behaviors in low- and middle-income countries. The primary objective of this review is to systematically review the literature examining the efficacy of VCT in changing HIV-related risk behaviors in developing countries across various populations. Five electronic databases - PubMed, Excerpta Medica Database (EMBASE), PsycINFO, Sociological Abstracts, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) - were searched using predetermined key words and phrases. Hand-searching was conducted in four key journals including AIDS, AIDS and Behavior, AIDS Education and Prevention, and AIDS Care; the tables of contents of these four journals during the included time period were individually screened for relevant articles. The reference lists of all articles included in the review were screened to identify any additional studies; this process was iterated until no additional articles were found. To be included in the review, eligible studies had to meet the following inclusion criteria: 1) Take place in a low- or middle-income country as defined by the World Bank, 2) Published in a peer-reviewed journal between January 1, 1990 and July 6, 2010, 3) Involve client-initiated VCT, including pre-test counseling, HIV-testing, and post-test counseling, and 4) Use a pre/post or multi-arm design that compares individuals before and after receiving VCT or individuals who received VCT to those who did not, and 5) Report results pertaining to behavioral, psychological, biological, or social HIV-related outcomes. All citations were initially screened and all relevant citations were independently screened by two reviewers to assess eligibility. For all included studies data were extracted by two team members working independently using a standardized form.  Differences were resolved through consensus or discussion with the study coordinator when necessary. Study rigor was assessed using an eight point quality score and through the Cochrane Collaboration's Risk of Bias Assessment Tool. Outcomes comparable across studies, including condom use and number of sex partners, were meta-analyzed using random effects models. With respect to both meta-analyses, data were included from multi-arm studies and from pre/post studies if adequate data were provided. Other outcomes, including HIV-incidence, STI incidence/prevalence, and positive and negative life events were synthesized qualitatively. For meta-analysis, all outcomes were converted to the standard metric of the odds ratio. If an outcome could not be converted to an odds ratio, the study was excluded from analysis.  An initial search yielded 2808 citations. After excluding studies failing to meet the inclusion criteria, 19 were deemed eligible for inclusion. Of these studies, two presented duplicate data and were removed. The remaining 17 studies were included in the qualitative synthesis and 8 studies were meta-analyzed.  Twelve studies offered  clinic-based VCT, 3 were employment-based, 1 involved mobile VCT, and 1 provided home-based VCT.  In meta-analysis, the odds of reporting increased number of sexual partners were reduced when comparing participants who received VCT to those who did not, unadjusted random effects pooled OR= 0.69 (95% CI: 0.53-0.90, p=0.007). When stratified by serostatus, these results only remained significant for those who tested HIV-positive. There was an insignificant increase in the odds of condom use/protected sex among participants who received VCT compared to those who did not, unadjusted random effects pooled OR=1.39 (95% CI: 0.97-1.99, p=0.076). When stratified by HIV status, this effect became significant among HIV-positive participants, random effects pooled OR= 3.24 (95% CI: 2.29-4.58, p<0.001). These findings add to growing evidence that VCT can change HIV-related sexual risk behaviors thereby reducing HIV-related risk, and confirming its importance as an HIV prevention strategy. To maximize the effectiveness of VCT, more studies should be conducted to understand which modalities and counseling strategies produce significant reductions in risky behaviors and lead to the greatest uptake of VCT.

  14. Predictors of good general health, well-being, and musculoskeletal disorders in Swedish dental hygienists.

    PubMed

    Ylipää, V; Arnetz, B B; Preber, H

    1999-10-01

    The aim of the present study was to examine how different personal, physical, and psychosocial work-associated factors are related to good general health, well-being, and musculoskeletal disorders in dental hygienists. A questionnaire was mailed to 575 dental hygienists who were randomly sampled from the Swedish Dental Hygienists' Association (86% responded). Data were analyzed with multiple-logistic regression models. The results showed that high clinical-practice fraction, active leisure, and high management support increased the odds for good general health, while work and family overload decreased the odds. Management support and mastery of work increased the odds for well-being, while work and family overload and high work efficiency decreased them. Scaling work increased the odds for general and work-related musculoskeletal disorders in all parts of the upper body and arms but not in the lower back. In the upper body, active leisure decreased the odds for general musculoskeletal disorders, while the odds for work-related musculoskeletal disorders increased from work and family overload and decreased from many weekly working hours. Many years in the profession increased the odds for general finger disorders. In conclusion, the results suggest that active leisure and several psychosocial work factors strongly influence good general health and well-being. Physical tasks influence musculoskeletal disorders more than active leisure and psychosocial work factors.

  15. Pharmacy customers' knowledge of side effects of purchased medicines in Mexico.

    PubMed

    Wirtz, Veronika J; Taxis, Katja; Dreser, Anahi

    2009-01-01

    To analyse pharmacy customers' knowledge and information sources about side effects of medicines they purchased and factors associated with this knowledge. Cross-sectional survey and semi-structured interviews with customers of 52 randomly selected community pharmacies in Morelos state, Mexico. Customers were included if they were older than 18 years, bought at least one drug either with or without medical prescription, and agreed to take part in the survey. Data were analysed using a multinomial logistic regression model. A total of 1445 customers buying 1946 drugs were surveyed (age 42.9 +/- 15.7 years, 56.9% female); 627 (59%) of 1055 customers who purchased prescription-only medicines (POM) did so without a prescription. Of all customers interviewed, 172 (11.9%) affirmed that the bought medicine(s) could cause harm. Only half of those (87 or 6%) were able to identify correctly at least one side effect of the purchased medicines. The majority received the information about side effects from a physician. Customers in semirural areas knew less about side effects (odds ratio: 0.26; 95% CI: 0.11-0.61; P = 0.00); whereas customers buying medicines for chronic pain, hypertension or diabetes knew more (odds ratio 2.63; 95% CI: 1.44-4.80; P = 0.00). The overall majority of customers did not know that medicines they bought could be harmful. This is particularly alarming because they frequently used POM without consulting a physician.

  16. Calculation of (P,T) -odd electric dipole moments for the diamagnetic atoms X129e , Y171b , H199g , R211n , and R225a

    NASA Astrophysics Data System (ADS)

    Dzuba, V. A.; Flambaum, V. V.; Porsev, S. G.

    2009-09-01

    Electric dipole moments of diamagnetic atoms of experimental interest are calculated using the relativistic Hartree-Fock and random-phase approximation methods, the many-body perturbation theory, and the configuration-interaction technique. We consider (P,T) -odd interactions, which give rise to atomic electric dipole moment in the second order of the perturbation theory. These include nuclear Schiff moment, (P,T) -odd electron-nucleon interaction, and electron electric dipole moment. Interpretation of an experimental constraint of a permanent electric dipole moment of H199g [W. C. Griffith, M. D. Swallows, T. H. Loftus, M. V. Romalis, B. R. Heckel, and E. N. Fortson, Phys. Rev. Lett. 102, 101601 (2009)] is discussed.

  17. Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations: Individual-patient-data meta-analysis of randomized trials.

    PubMed

    Hacke, Werner; Lyden, Patrick; Emberson, Jonathan; Baigent, Colin; Blackwell, Lisa; Albers, Gregory; Bluhmki, Erich; Brott, Thomas; Cohen, Geoffrey; Davis, Stephen M; Donnan, Geoffrey A; Grotta, James C; Howard, George; Kaste, Markku; Koga, Masatoshi; von Kummer, Rüdiger; Lansberg, Maarten G; Lindley, Richard I; Olivot, Jean-Marc; Parsons, Mark; Sandercock, Peter Ag; Toni, Danilo; Toyoda, Kazunori; Wahlgren, Nils; Wardlaw, Joanna M; Whiteley, William N; Del Zoppo, Gregory; Lees, Kennedy R

    2018-02-01

    Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0-1) at 3-6 months, the distribution of modified Rankin score, symptomatic intracerebral hemorrhage, and 90-day mortality. Results Alteplase increased the odds of modified Rankin score 0-1 among 2449/6136 (40%) patients who met the current European Union label and 3491 (57%) patients who met the age-revised label (odds ratio 1.42, 95% CI 1.21-1.68 and 1.43, 1.23-1.65, respectively), but not in those outside the age-revised label (1.06, 0.90-1.26). By 90 days, there was no increased mortality in the current and age-revised cohorts (hazard ratios 0.98, 95% CI 0.76-1.25 and 1.01, 0.86-1.19, respectively) but mortality remained higher outside the age-revised label (1.19, 0.99-1.42). Similarly, alteplase increased the odds of modified Rankin score 0-1 among 1174/6136 (19%) patients who met the current US approval and 3326 (54%) who met a 4.5-h revised approval (odds ratio 1.55, 1.19-2.01 and 1.37, 1.17-1.59, respectively), but not for those outside the 4.5-h revised approval (1.14, 0.97-1.34). By 90 days, no increased mortality remained for the current and 4.5-h revised label cohorts (hazard ratios 0.99, 0.77-1.26 and 1.02, 0.87-1.20, respectively) but mortality remained higher outside the 4.5-h revised approval (1.17, 0.98-1.41). Conclusions An age-revised European Union label or 4.5-h-revised United States label would each increase the number of patients deriving net benefit from alteplase by 90 days after acute ischemic stroke, without excess mortality.

  18. Comparative Effectiveness of Mesalamine, Sulfasalazine, Corticosteroids, and Budesonide for the Induction of Remission in Crohn's Disease: A Bayesian Network Meta-analysis.

    PubMed

    Coward, Stephanie; Kuenzig, M Ellen; Hazlewood, Glen; Clement, Fiona; McBrien, Kerry; Holmes, Rebecca; Panaccione, Remo; Ghosh, Subrata; Seow, Cynthia H; Rezaie, Ali; Kaplan, Gilaad G

    2017-03-01

    Induction treatment of mild-to-moderate Crohn's disease is controversial. To compare the induction of remission between different doses of mesalamine, sulfasalazine, corticosteroids, and budesonide for active Crohn's disease. We identified randomized controlled trials from existing Cochrane reviews and an updated literature search in Medline, EMBASE, and CENTRAL to November 2015. We included randomized controlled trials (n = 22) in adult patients with Crohn's disease that compared budesonide, sulfasalazine, mesalamine, or corticosteroids with placebo or each other, for the induction of remission (8-17 wks). Mesalamine (above and below 2.4 g/d) and budesonide (above and below 6 mg/d) were stratified into low and high doses. Our primary outcome was remission, defined as a Crohn's Disease Activity Index score <150. A Bayesian random-effects network meta-analysis was performed on the proportion in remission. Corticosteroids (odds ratio [OR] = 3.80; 95% credible interval [CrI]: 2.48-5.66), high-dose budesonide (OR = 2.96; 95% CrI: 2.06-4.30), and high-dose mesalamine (OR = 2.29; 95% CrI: 1.58-3.33) were superior to placebo. Corticosteroids were similar to high-dose budesonide (OR = 1.21; 95% CrI: 0.84-1.76), but more effective than high-dose mesalamine (OR = 1.83; 95% CrI: 1.16-2.88). Sulfasalazine was not significantly superior to any therapy including placebo. Randomized controlled trials that use a strict definition of induction of remission and disease severity at enrollment to assess effectiveness in treating mild-to-moderate Crohn's disease are limited. Corticosteroids and high-dose budesonide were effective treatments for inducing remission in mild-to-moderate Crohn's disease. High-dose mesalamine is an option among patients preferring to avoid steroids.

  19. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial.

    PubMed

    Xu, Sha-bei; Huang, Bo; Zhang, Chen-yan; Du, Peng; Yuan, Qi; Bi, Gui-juan; Zhang, Gui-bin; Xie, Min-jie; Luo, Xiang; Huang, Guang-ying; Wang, Wei

    2013-04-02

    The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization. After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23-7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29-13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33-37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04-1.09). Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. Clinicaltrials.gov no. NCT00685789.

  20. Comparative Effectiveness of Nonsteroidal Anti-inflammatory Drug Treatment vs No Treatment for Patent Ductus Arteriosus in Preterm Infants.

    PubMed

    Slaughter, Jonathan L; Reagan, Patricia B; Newman, Thomas B; Klebanoff, Mark A

    2017-03-06

    Patent ductus arteriosus (PDA) is associated with increased mortality and worsened respiratory outcomes, including bronchopulmonary dysplasia (BPD), in preterm infants. Nonsteroidal anti-inflammatory drugs (NSAIDs) are efficacious in closing PDA, but the effectiveness of NSAID-mediated PDA closure in improving mortality and preventing BPD is unclear. To determine the effectiveness of NSAID treatment for PDA in reducing mortality and moderate/severe BPD at 36 weeks postmenstrual age. This cohort study included 12 018 infants born at 28 gestational weeks or younger discharged between January 2006 and December 2013 from neonatal intensive care units in 25 US children's hospitals included in the Pediatric Health Information System. We performed an instrumental variable analysis that incorporated clinician preference-based, institutional variation in NSAID treatment frequency to determine the effect of NSAID treatment for PDA on mortality and BPD. Proportion of NSAID-treated infants born at each infant's institution within ±6 months of that infant's birth. The primary composite outcome was death, moderate, or severe BPD at 36 weeks postmenstrual age. Of the 6370 male and 5648 female infants in this study, 4995 (42%) were white, 3176 (26%) were African American, 1823 (15%) were Hispanic, and 1555 (13%) were other races/ethnicities. The proportion of NSAID-treated infants at each infant's hospital within ±6 months of that infant's birth was associated with NSAID treatment and not associated with gestation, race/ethnicity, or sex. An infant's chances of receiving NSAID treatment increased by 0.84% (95% CI, 0.8-0.9; P < .001) for every 1% increase in the annual NSAID treatment percentage at a given hospital. An instrumental variable analysis demonstrated no association between NSAID treatment and the odds of mortality or BPD (odds ratio, 0.94; 95% CI, 0.70-1.25; P = .69), mortality (odds ratio, 0.73; 95% CI, 0.43-1.13; P = .18), or BPD (odds ratio, 1.01; 95% CI, 0.73-1.45; P = .94) in survivors. When we incorporated clinician preference-based practice variation as an instrument to minimize the effect of unmeasured confounding, we detected no changes in the odds of mortality or moderate/severe BPD among similar preterm infants born at 28 weeks or younger following NSAID treatment for PDA initiated 2 to 28 days postnatally. Our findings agree with available randomized clinical trial evidence and support a conservative approach to PDA management.

  1. The use of computerized birthday greeting reminders in the management of diabetes.

    PubMed

    Lafata, Jennifer Elston; Baker, Ann M; Divine, George W; McCarthy, Bruce D; Xi, Hugo

    2002-07-01

    Although mailed reminders have been used for prevention among general populations, few studies have evaluated their effectiveness among chronically ill populations. We evaluated the effectiveness of mailed reminders for improving diabetes management. The reminder included a letter from the individual's primary care physician (PCP), a self-care handbook, a preventive care checklist, and specific recommendations regarding receipt of routine monitoring and screening. Of 195 PCPs practicing with a large group practice, 111 agreed to have their adult patients with diabetes randomized to receive the reminder (n = 1,641) or usual care (n = 1,668). Using data from automated databases, we fit generalized estimating equations to evaluate the effect of reminder receipt on fasting lipid profile and glycated hemoglobin testing, dilated retinal exam receipt, and visit frequency during the 6 and 12 months following randomization, and glycated hemoglobin and cholesterol levels in the year following randomization. Reminder and usual care recipients did not differ in sociodemographic, clinical, or prior testing characteristics. In the 6 months following randomization, reminder recipients were more likely to receive a retinal exam (odds ratio [OR], 1.29; 95% confidence interval [95% CI], 1.12 to 1.49) and diabetes visit (OR, 1.28; 95% CI, 1.12 to 1.47). In the 12 months following randomization, reminder recipients were more likely to receive a glycated hemoglobin test (OR, 1.21; 95% CI, 1.03 to 1.43), retinal exam (OR, 1.23; 95% CI, 1.07 to 1.41), and diabetes visit (OR, 1.25; 95% CI, 1.09 to 1.29). In the follow-up year, reminder recipients also tended to have a glycated hemoglobin test that did not reflect poor control (<9.5%). We found small but significant improvements in the management of patients with diabetes receiving a computerized mailed reminder.

  2. Reduction in Purchases of Sugar-Sweetened Beverages Among Low-Income Black Adolescents After Exposure to Caloric Information

    PubMed Central

    Herring, Bradley J.; Flagg, Desmond D.; Gary-Webb, Tiffany L.

    2012-01-01

    Objectives. We examined the effect of an intervention to provide caloric information about sugar-sweetened beverages (SSBs) on the number of SSB purchases. Methods. We used a case-crossover design with 4 corner stores located in low-income, predominately Black neighborhoods in Baltimore, Maryland. The intervention randomly posted 1 of 3 signs with the following caloric information: (1) absolute caloric count, (2) percentage of total recommended daily intake, and (3) physical activity equivalent. We collected data for 1600 beverage sales by Black adolescents, aged 12–18 years, including 400 during a baseline period and 400 for each of the 3 caloric condition interventions. Results. Providing Black adolescents with any caloric information significantly reduced the odds of SSB purchases relative to the baseline (odds ratio [OR] = 0.56; 95% confidence interval [CI] = 0.36, 0.89). When examining the 3 caloric conditions separately, the significant effect was observed when caloric information was provided as a physical activity equivalent (OR = 0.51; 95% CI = 0.31, 0.85). Conclusions. Providing easily understandable caloric information—particularly a physical activity equivalent—may reduce calorie intake from SSBs among low-income, Black adolescents. PMID:22390447

  3. Is Angiosome-Targeted Angioplasty Effective for Limb Salvage and Wound Healing in Diabetic Foot? : A Meta-Analysis.

    PubMed

    Chae, Kum Ju; Shin, Jin Yong

    2016-01-01

    Given that the efficacy of employing angiosome-targeted angioplasty in the treatment of diabetic foot remains controversial, this study was conducted to examine its efficacy. We performed a systematic literature review and meta-analysis using core databases, extracting the treatment modality of angiosome-targeted angioplasty as the predictor variable, and limb salvage, wound healing, and revision rate as the outcome variables. We used the Newcastle-Ottawa Scale to assess the study quality, along with the Cochrane Risk of Bias Tool. We evaluated publication bias using a funnel plot. The search strategy identified 518 publications. After screening these, we selected four articles for review. The meta-analysis revealed that overall limb salvage and wound healing rates were significantly higher (Odds ratio = 2.209, 3.290, p = 0.001, p<0.001) in patients who received angiosome-targeted angioplasty than in those who received nonangiosome-targeted angioplasty. The revision rate between the angiosome and nonangiosome groups was not significantly different (Odds ratio = 0.747, p = 0.314). Although a further randomized controlled trial is required for confirmation, angiosome-targeted angioplasty in diabetic foot was more effective than nonangiosome-targeted angioplasty with respect to wound healing and limb salvage.

  4. Nighttime snacking, stress, and migraine activity

    PubMed Central

    Turner, Dana P.; Smitherman, Todd A.; Penzien, Donald B.; Porter, John A. H.; Martin, Vincent T.; Houle, Timothy T.

    2013-01-01

    Missing meals and fasting have long been reported as headache triggers. Stress also has received attention for its role in precipitating headaches. This study explored the effects of eating behaviors on new-onset headache. Analyzing only the 1070 of 1648 (64.9%) diary days that followed a non-headache day, the study included 34 migraineurs who contributed a median (25th, 75th percentile) of 28 (22, 40) days of diary entries. Multivariable survival modeling with random effects was conducted, and hazards ratios and 95% confidence intervals were calculated. Nighttime snacking was associated with a 40% reduction in the odds of experiencing a headache compared to having no food (p = 0.013). Eating a late dinner was associated with a 21% reduction in the odds of headache when compared to no additional food, but this association was not statistically significant (p = 0. 22). These results demonstrate the potential for eating behaviors to be targeted in headache management, as regulated eating habits may have the potential to reduce the occurrence of headache. Although no causal relationship can be established, these results indicate that further research into the mechanisms of the association between eating behaviors and headache activity is warranted. PMID:24417796

  5. Impact of Early Head Start in North Carolina on Dental Care Use Among Children Younger Than 3 Years.

    PubMed

    Burgette, Jacqueline M; Preisser, John S; Weinberger, Morris; King, Rebecca S; Lee, Jessica Y; Rozier, R Gary

    2017-04-01

    To examine the effects of North Carolina Early Head Start (EHS), an early education program for low-income children younger than 3 years and their families, on dental care use among children. We performed a quasi-experimental study in which we interviewed 479 EHS and 699 non-EHS parent-child dyads at baseline (2010-2012) and at a 24-month follow-up (2012-2014). We estimated the effects of EHS participation on the probability of having a dental care visit after controlling for baseline dental care need and use and a propensity score covariate; we included random effects to account for EHS program clustering. The odds of having a dental care visit of any type (adjusted odds ratio [OR] = 2.5; 95% confidence interval [CI] = 1.74, 3.48) and having a preventive dental visit (adjusted OR = 2.6; 95% CI = 1.84, 3.63) were higher among EHS children than among non-EHS children. In addition, the adjusted mean number of dental care visits among EHS children was 1.3 times (95% CI = 1.17, 1.55) the mean number among non-EHS children. This study is the first, to our knowledge, to demonstrate that EHS participation increases dental care use among disadvantaged young children.

  6. Distinguishing spin-aligned and isotropic black hole populations with gravitational waves.

    PubMed

    Farr, Will M; Stevenson, Simon; Miller, M Coleman; Mandel, Ilya; Farr, Ben; Vecchio, Alberto

    2017-08-23

    The direct detection of gravitational waves from merging binary black holes opens up a window into the environments in which binary black holes form. One signature of such environments is the angular distribution of the black hole spins. Binary systems that formed through dynamical interactions between already-compact objects are expected to have isotropic spin orientations (that is, the spins of the black holes are randomly oriented with respect to the orbit of the binary system), whereas those that formed from pairs of stars born together are more likely to have spins that are preferentially aligned with the orbit. The best-measured combination of spin parameters for each of the four likely binary black hole detections GW150914, LVT151012, GW151226 and GW170104 is the 'effective' spin. Here we report that, if the magnitudes of the black hole spins are allowed to extend to high values, the effective spins for these systems indicate a 0.015 odds ratio against an aligned angular distribution compared to an isotropic one. When considering the effect of ten additional detections, this odds ratio decreases to 2.9 × 10 -7 against alignment. The existing preference for either an isotropic spin distribution or low spin magnitudes for the observed systems will be confirmed (or overturned) confidently in the near future.

  7. [On the effectiveness of the homeopathic remedy Arnica montana].

    PubMed

    Lüdtke, Rainer; Hacke, Daniela

    2005-11-01

    Arnica montana is a homeopathic remedy often prescribed after traumata and injuries. To assess whether Arnica is effective beyond placebo and to identify factors which support or contradict this effectiveness. All prospective, controlled trials on the effectiveness of homeopathic Arnica were included. Overall effectiveness was assessed by meta-analysis and meta-regression techniques. 68 comparisons from 49 clinical trials show a significant effectiveness of Arnica in traumatic injuries in random effects meta-analysis (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.24-0.55), but not in meta-regression models (OR, 0.37; CI, 0.11-1.24). We found no evidence for publication bias. Studies from Medline-listed journals and high-quality studies are less likely to report positive results (p = 0.0006 and p = 0.0167). The hypothesis that homeopathic Arnica is effective could neither be proved nor rejected. All trials were highly heterogeneous, meta-regression does not help to explain this heterogeneity substantially.

  8. Illness representation on H1N1 influenza and preventive behaviors in the Hong Kong general population.

    PubMed

    Mo, Phoenix K H; Lau, Joseph T F

    2015-12-01

    This study examined illness representations of new influenza Human Swine Influenza A (H1N1) and association with H1N1 preventive behaviors among 300 Chinese adults using a population-based randomized telephone survey. Results showed that relatively few participants thought H1N1 would have serious consequences (12%-15.7%) and few showed negative emotional responses toward H1N1 (9%-24.7%). The majority of the participants thought H1N1 could be controlled by treatment (70.4%-72.7%). Multiple logistic regression analyses showed that treatment control (odds ratio = 1.78) and psychological attribution (odds ratio = .75) were associated with intention to take up influenza vaccination. Emotional representations were associated with lower likelihood of wearing face mask (odds ratio = .77) and hand washing (odds ratio = .67). Results confirm that illness representation variables are associated with H1N1 preventive behaviors. © The Author(s) 2014.

  9. Do warning signs on electronic gaming machines influence irrational cognitions?

    PubMed

    Monaghan, Sally; Blaszczynski, Alex; Nower, Lia

    2009-08-01

    Electronic gaming machines are popular among problem gamblers; in response, governments have introduced "responsible gaming" legislation incorporating the mandatory display of warning signs on or near electronic gaming machines. These signs are designed to correct irrational and erroneous beliefs through the provision of accurate information on probabilities of winning and the concept of randomness. There is minimal empirical data evaluating the effectiveness of such signs. In this study, 93 undergraduate students were randomly allocated to standard and informative messages displayed on an electronic gaming machine during play in a laboratory setting. Results revealed that a majority of participants incorrectly estimated gambling odds and reported irrational gambling-related cognitions prior to play. In addition, there were no significant between-group differences, and few participants recalled the content of messages or modified their gambling-related cognitions. Signs placed on electronic gaming machines may not modify irrational beliefs or alter gambling behaviour.

  10. The Effect on Treatment Adherence of Administering Drugs as Fixed-Dose Combinations versus as Separate Pills: Systematic Review and Meta-Analysis.

    PubMed

    van Galen, Katy A; Nellen, Jeannine F; Nieuwkerk, Pythia T

    2014-01-01

    Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a quantitative estimate of treatment adherence, without restriction to medical condition. The odds ratio (OR) of optimal adherence with FDCs versus separate pills was used as common effect size and aggregated into a pooled effect estimate using a random effect model with inverse variance weights. Out of 1258 articles screened, only six studies fulfilled inclusion criteria. Across medical conditions, administering drugs as FDC significantly increased the likelihood of optimal adherence (OR 1.33 (95% CI, 1.03-1.71)). Within subgroups of specific medical conditions, the favourable effect of FDCs on adherence was of borderline statistical significance for HIV infection only (OR 1.46 (95% CI, 1.00-2.13)). We observed a remarkable paucity of RCTs comparing the effect on adherence of administering drugs as FDC versus as separate pills. Administering drugs as FDC improved medication adherence. However, this conclusion is based on a limited number of RCTs only.

  11. Testing concordance of instrumental variable effects in generalized linear models with application to Mendelian randomization

    PubMed Central

    Dai, James Y.; Chan, Kwun Chuen Gary; Hsu, Li

    2014-01-01

    Instrumental variable regression is one way to overcome unmeasured confounding and estimate causal effect in observational studies. Built on structural mean models, there has been considerale work recently developed for consistent estimation of causal relative risk and causal odds ratio. Such models can sometimes suffer from identification issues for weak instruments. This hampered the applicability of Mendelian randomization analysis in genetic epidemiology. When there are multiple genetic variants available as instrumental variables, and causal effect is defined in a generalized linear model in the presence of unmeasured confounders, we propose to test concordance between instrumental variable effects on the intermediate exposure and instrumental variable effects on the disease outcome, as a means to test the causal effect. We show that a class of generalized least squares estimators provide valid and consistent tests of causality. For causal effect of a continuous exposure on a dichotomous outcome in logistic models, the proposed estimators are shown to be asymptotically conservative. When the disease outcome is rare, such estimators are consistent due to the log-linear approximation of the logistic function. Optimality of such estimators relative to the well-known two-stage least squares estimator and the double-logistic structural mean model is further discussed. PMID:24863158

  12. Drug Violations and Aviation Accidents: Findings from the U.S. Mandatory Drug Testing Programs

    PubMed Central

    Li, Guohua; Baker, Susan P.; Zhao, Qi; Brady, Joanne E.; Lang, Barbara H.; Rebok, George W.; DiMaggio, Charles

    2012-01-01

    Aims To assess the role of drug violations in aviation accidents. Design Case-control analysis. Setting Commercial aviation in the United States. Participants Aviation employees who were tested for drugs during 1995 through 2005 under the post-accident testing program (cases, n=4,977) or under the random testing program (controls, n=1,129,922). Measurements Point prevalence of drug violations, odds ratio of accident involvement, and attributable risk in the population. A drug violation was defined as a confirmed positive test for marijuana (≥ 50 ng/ml), cocaine (≥ 300 ng/ml), amphetamines (≥1000 ng/ml), opiates (≥ 2000 ng/ml), or phencyclidine (≥ 25 ng/ml). Findings The prevalence of drug violations was 0.64% [95% confidence interval (CI), 0.62–0.65%] in random drug tests and 1.82% (95% CI, 1.47–2.24%) in post-accident tests. The odds of accident involvement for employees who tested positive for drugs was almost three times the odds for those who tested negative (odds ratio 2.90, 95% CI, 2.35–3.57), with an estimated attributable risk of 1.2%. Marijuana accounted for 67.3% of the illicit drugs detected. The proportion of illicit drugs represented by amphetamines increased progressively during the study period, from 3.4% in 1995 to 10.3% in 2005 (p<0.0001). Conclusions Use of illicit drugs by aviation employees is associated with a significantly increased risk of accident involvement. Due to the very low prevalence, drug violations contribute to only a small fraction of aviation accidents. PMID:21306594

  13. A Bell inequality for a class of multilocal ring networks

    NASA Astrophysics Data System (ADS)

    Frey, Michael

    2017-11-01

    Quantum networks with independent sources of entanglement (hidden variables) and nodes that execute joint quantum measurements can create strong quantum correlations spanning the breadth of the network. Understanding of these correlations has to the present been limited to standard Bell experiments with one source of shared randomness, bilocal arrangements having two local sources of shared randomness, and multilocal networks with tree topologies. We introduce here a class of quantum networks with ring topologies comprised of subsystems each with its own internally shared source of randomness. We prove a Bell inequality for these networks, and to demonstrate violations of this inequality, we focus on ring networks with three-qubit subsystems. Three qubits are capable of two non-equivalent types of entanglement, GHZ and W-type. For rings of any number N of three-qubit subsystems, our inequality is violated when the subsystems are each internally GHZ-entangled. This violation is consistently stronger when N is even. This quantitative even-odd difference for GHZ entanglement becomes extreme in the case of W-type entanglement. When the ring size N is even, the presence of W-type entanglement is successfully detected; when N is odd, the inequality consistently fails to detect its presence.

  14. Logistic random effects regression models: a comparison of statistical packages for binary and ordinal outcomes

    PubMed Central

    2011-01-01

    Background Logistic random effects models are a popular tool to analyze multilevel also called hierarchical data with a binary or ordinal outcome. Here, we aim to compare different statistical software implementations of these models. Methods We used individual patient data from 8509 patients in 231 centers with moderate and severe Traumatic Brain Injury (TBI) enrolled in eight Randomized Controlled Trials (RCTs) and three observational studies. We fitted logistic random effects regression models with the 5-point Glasgow Outcome Scale (GOS) as outcome, both dichotomized as well as ordinal, with center and/or trial as random effects, and as covariates age, motor score, pupil reactivity or trial. We then compared the implementations of frequentist and Bayesian methods to estimate the fixed and random effects. Frequentist approaches included R (lme4), Stata (GLLAMM), SAS (GLIMMIX and NLMIXED), MLwiN ([R]IGLS) and MIXOR, Bayesian approaches included WinBUGS, MLwiN (MCMC), R package MCMCglmm and SAS experimental procedure MCMC. Three data sets (the full data set and two sub-datasets) were analysed using basically two logistic random effects models with either one random effect for the center or two random effects for center and trial. For the ordinal outcome in the full data set also a proportional odds model with a random center effect was fitted. Results The packages gave similar parameter estimates for both the fixed and random effects and for the binary (and ordinal) models for the main study and when based on a relatively large number of level-1 (patient level) data compared to the number of level-2 (hospital level) data. However, when based on relatively sparse data set, i.e. when the numbers of level-1 and level-2 data units were about the same, the frequentist and Bayesian approaches showed somewhat different results. The software implementations differ considerably in flexibility, computation time, and usability. There are also differences in the availability of additional tools for model evaluation, such as diagnostic plots. The experimental SAS (version 9.2) procedure MCMC appeared to be inefficient. Conclusions On relatively large data sets, the different software implementations of logistic random effects regression models produced similar results. Thus, for a large data set there seems to be no explicit preference (of course if there is no preference from a philosophical point of view) for either a frequentist or Bayesian approach (if based on vague priors). The choice for a particular implementation may largely depend on the desired flexibility, and the usability of the package. For small data sets the random effects variances are difficult to estimate. In the frequentist approaches the MLE of this variance was often estimated zero with a standard error that is either zero or could not be determined, while for Bayesian methods the estimates could depend on the chosen "non-informative" prior of the variance parameter. The starting value for the variance parameter may be also critical for the convergence of the Markov chain. PMID:21605357

  15. Factors associated with consultation behaviour for primary symptoms potentially indicating colorectal cancer: A cross-sectional study on response to symptoms

    PubMed Central

    2012-01-01

    Background Little data exists on the factors associated with health care seeking behaviour for primary symptoms of colorectal cancer (CRC). This study aimed to identify individual, provider and psychosocial factors associated with (i) ever seeking medical advice and (ii) seeking early medical advice for primary symptoms of colorectal cancer (CRC). Methods 1592 persons aged 56–88 years randomly selected from the Hunter Community Study (HCS) were sent a questionnaire. Results Males and those who had received screening advice from a doctor were at significantly higher odds of ever seeking medical advice for rectal bleeding. Persons who had private health coverage, consulted a doctor because the ‘symptom was serious’, or who did not wait to consult a doctor for another reason were at significantly higher odds of seeking early medical advice (< 2 weeks). For change in bowel habit, persons with lower income, within the healthy weight range, or who had discussed their family history of CRC irrespective of whether informed of ‘increased risk’ were at significantly higher odds of ever seeking medical advice. Persons frequenting their GP less often and seeing their doctor because the symptom persisted were at significantly higher odds of seeking early medical advice (< 2 weeks). Conclusions The seriousness of symptoms, importance of early detection, and prompt consultation must be articulated in health messages to at-risk persons. This study identified modifiable factors, both individual and provider-related to consultation behaviour. Effective health promotion efforts must heed these factors and target sub-groups less likely to seek early medical advice. PMID:22862960

  16. Can cash break the cycle of educational risks for young children in high HIV-affected communities? A cross-sectional study in South Africa and Malawi.

    PubMed

    Sherr, Lorraine; Tomlinson, Mark; Macedo, Ana; Skeen, Sarah; Hensels, Imca Sifra; Cluver, Lucie Dale

    2017-12-01

    Household cash grants are associated with beneficial outcomes; enhanced if provided in combination with care. This study describes the impact of cash grants and parenting quality on 854 children aged 5-15 (South African and Malawi) on educational outcomes including enrolment, regular attendance, correct class for age and school progress (controlling for cognitive performance). Consecutive attenders at randomly selected Community based organisations were recruited. The effects of cash plus good parenting, HIV status and gender were examined. Overall 73.1% received a grant - significantly less children with HIV (57.3% vs 75.6% (χ 2  = 17.21, P  < 0.001). Controlling for cognitive ability, grant receipt was associated with higher odds of being in the correct grade (odds ratio (OR) = 2.00; 95% confidence interval (CI) = 1.36, 2.95), higher odds of attending school regularly (OR = 3.62; 95% CI = 1.77, 7.40), and much higher odds of having missed less than a week of school recently (OR = 8.95; 95% CI = 2.27, 35.23). Grant receipt was not associated with how well children performed in school compared to their classmates or with school enrolment. Linear regression revealed that grant receipt was associated with a significant reduction in educational risk (B = -0.32, t (420) = 2.84, P  = 0.005) for girls. Cash plus good parenting affected some educational outcomes in a stepwise manner, but did not provide additive protection.

  17. Diet and its relationship to sarcopenia in community dwelling Iranian elderly: a cross sectional study.

    PubMed

    Hashemi, Rezvan; Motlagh, Ahmadreza Dorosty; Heshmat, Ramin; Esmaillzadeh, Ahmad; Payab, Moloud; Yousefinia, Mahsa; Siassi, Fereydoun; Pasalar, Parvin; Baygi, Fereshteh

    2015-01-01

    Sarcopenia is associated with frailty and disability among the elderly and imposes significant costs on health care systems. We tested whether adherence to a particular dietary pattern was associated with sarcopenia among the elderly in a district of Tehran, Iran. We used a semiquantitative Food Frequency Questionnaire to assess the dietary intake of 300 randomly-selected elderly men and women (at least 55 y old) living in the sixth district of Tehran; and the dietary patterns of the subjects were obtained using principal component analysis. We performed a logistic regression to measure the effect of adherence to each dietary pattern on the odds of sarcopenia. Subjects in the highest tertile of the Mediterranean dietary pattern, characterized by a higher consumption of olive oil, fruits, vegetables, fish, and nuts, had a lower odds ratio for sarcopenia than those in the lowest tertile (OR = 0.42; 95% CI = 0.18-0.97; P for trend = 0.04). In contrast, adherence to the Western dietary pattern, characterized by a high consumption of sugar, soy, and fast foods, was not associated with sarcopenia (OR = 0.51; 95% CI = 0.21-1.24; P for trend = 0.13). Similarly, adherence to the Mixed dietary pattern, characterized by a high consumption of animal proteins, potatoes, and refined grains, did not affect the odds of sarcopenia (OR = 1.45; 95% CI = 0.66-3.19; P for trend = 0.95). This study suggests that adherence to the Mediterranean diet is associated with lower odds of sarcopenia among the Iranian elderly. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. High adherence to the Western, Prudent, and Mediterranean dietary patterns and risk of gastric adenocarcinoma: MCC-Spain study.

    PubMed

    Castelló, Adela; Fernández de Larrea, Nerea; Martín, Vicente; Dávila-Batista, Verónica; Boldo, Elena; Guevara, Marcela; Moreno, Víctor; Castaño-Vinyals, Gemma; Gómez-Acebo, Inés; Fernández-Tardón, Guillermo; Peiró, Rosana; Olmedo-Requena, Rocío; Capelo, Rocio; Navarro, Carmen; Pacho-Valbuena, Silvino; Pérez-Gómez, Beatriz; Kogevinas, Manolis; Pollán, Marina; Aragonés, Nuria

    2018-05-01

    The influence of dietary habits on the development of gastric adenocarcinoma is not clear. The objective of the present study was to explore the association of three previously identified dietary patterns with gastric adenocarcinoma by sex, age, cancer site, and morphology. MCC-Spain is a multicase-control study that included 295 incident cases of gastric adenocarcinoma and 3040 controls. The association of the Western, Prudent, and Mediterranean dietary patterns-derived in another Spanish case-control study-with gastric adenocarcinoma was assessed using multivariable logistic regression models with random province-specific intercepts and considering a possible interaction with sex and age. Risk according to tumor site (cardia, non-cardia) and morphology (intestinal/diffuse) was evaluated using multinomial regression models. A high adherence to the Western pattern increased gastric adenocarcinoma risk [odds ratio fourth_vs._first_quartile (95% confidence interval), 2.09 (1.31; 3.33)] even at low levels [odds ratio second_vs._first_quartile (95% confidence interval), 1.63 (1.05; 2.52)]. High adherence to the Mediterranean dietary pattern could prevent gastric adenocarcinoma [odds ratio fourth_vs._first_quartile (95% confidence interval), 0.53 (0.34; 0.82)]. Although no significant heterogeneity of effects was observed, the harmful effect of the Western pattern was stronger among older participants and for non-cardia adenocarcinomas, whereas the protective effect of the Mediterranean pattern was only observed among younger participants and for non-cardia tumors. Decreasing the consumption of fatty and sugary products and of red and processed meat in favor of an increase in the intake of fruits, vegetables, legumes, olive oil, nuts, and fish might prevent gastric adenocarcinoma.

  19. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

    PubMed

    Als-Nielsen, Bodil; Chen, Wendong; Gluud, Christian; Kjaergard, Lise L

    2003-08-20

    Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.

  20. Risk of predation and weather events affect nest site selection by sympatric Pacific (Gavia pacifica) and Yellow-billed (Gavia adamsii) loons in Arctic habitats

    USGS Publications Warehouse

    Haynes, Trevor B.; Schmutz, Joel A.; Lindberg, Mark S.; Rosenberger, Amanda E.

    2014-01-01

    Pacific (Gavia pacifica) and Yellow-billed (G. adamsii) loons nest sympatrically in Arctic regions. These related species likely face similar constraints and requirements for nesting success; therefore, use of similar habitats and direct competition for nesting habitat is likely. Both of these loon species must select a breeding lake that provides suitable habitat for nesting and raising chicks; however, characteristics of nest site selection by either species on interior Arctic lakes remains poorly understood. Here, logistic regression was used to compare structural and habitat characteristics of all loon nest locations with random points from lakes on the interior Arctic Coastal Plain, Alaska. Results suggest that both loon species select nest sites to avoid predation and exposure to waves and shifting ice. Loon nest sites were more likely to be on islands and peninsulas (odds ratio = 16.13, 95% CI = 4.64–56.16) than mainland shoreline, which may help loons avoid terrestrial predators. Further, nest sites had a higher degree of visibility (mean degrees of visibility to 100 and 200 m) of approaching predators than random points (odds ratio = 2.57, 95% CI = 1.22–5.39). Nests were sheltered from exposure, having lower odds of being exposed to prevailing winds (odds ratio = 0.34, 95% CI = 0.13–0.92) and lower odds of having high fetch values (odds ratio = 0.46, 95% CI = 0.22–0.96). Differences between Pacific and Yellow-billed loon nesting sites were subtle, suggesting that both species have similar general nest site requirements. However, Yellow-billed Loons nested at slightly higher elevations and were more likely to nest on peninsulas than Pacific Loons. Pacific Loons constructed built up nests from mud and vegetation, potentially in response to limited access to suitable shoreline due to other territorial loons. Results suggest that land managers wishing to protect habitats for these species should focus on lakes with islands as well as shorelines sheltered from exposure to prevailing wind and ice patterns.

  1. Allowing for uncertainty due to missing continuous outcome data in pairwise and network meta-analysis.

    PubMed

    Mavridis, Dimitris; White, Ian R; Higgins, Julian P T; Cipriani, Andrea; Salanti, Georgia

    2015-02-28

    Missing outcome data are commonly encountered in randomized controlled trials and hence may need to be addressed in a meta-analysis of multiple trials. A common and simple approach to deal with missing data is to restrict analysis to individuals for whom the outcome was obtained (complete case analysis). However, estimated treatment effects from complete case analyses are potentially biased if informative missing data are ignored. We develop methods for estimating meta-analytic summary treatment effects for continuous outcomes in the presence of missing data for some of the individuals within the trials. We build on a method previously developed for binary outcomes, which quantifies the degree of departure from a missing at random assumption via the informative missingness odds ratio. Our new model quantifies the degree of departure from missing at random using either an informative missingness difference of means or an informative missingness ratio of means, both of which relate the mean value of the missing outcome data to that of the observed data. We propose estimating the treatment effects, adjusted for informative missingness, and their standard errors by a Taylor series approximation and by a Monte Carlo method. We apply the methodology to examples of both pairwise and network meta-analysis with multi-arm trials. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  2. Weekday-weekend variations in mother-/father-child physical activity and screen time relationship: A cross-sectional study in a random sample of Czech families with 5- to 12-year-old children.

    PubMed

    Sigmundová, Dagmar; Badura, Petr; Sigmund, Erik; Bucksch, Jens

    2018-05-23

    This study assessed the associations between these factors in a random sample of Czech families with preschool and school-aged children. A nationally representative sample comprised 185 families with preschool children and 649 families with school-aged children (dyads; both parents and child n = 365, mother and child n = 730, and father and child n = 469). The participants wore Yamax Digiwalker SW-200 pedometers at least four weekdays and both weekend days and completed family logbooks (anthropometric parameters, daily step counts (SC), and screen time (ST)). When a parent (fathers at weekends and mothers both on weekdays and at weekends) achieved 10,000 SC per day, their children were also significantly (OR = 2.93-6.06, 95% CI = 2.02-9.26) more likely to meet the daily SC recommendation. On the contrary, the involvement of fathers in organized leisure-time PA reduced their children's odds of meeting the SC recommendation on weekdays (OR = 0.53, 95% CI = 0.31-0.89) and at weekends (OR = 0.41, 95% CI = 0.24-0.72). The excessive ST of parents at weekends reduced the odds of their children meeting the SC recommendation (mother-child dyads: OR = 0.44, 95% CI = 0.26-0.72; father-child dyads: OR = 0.63, 95% CI = 0.37-1.06). High levels of parents' PA contribute to the achievement of the recommended daily PA in children on weekdays and at weekends. Excessive weekend ST of parents reduces their odds of their children achieving the recommended daily PA; however, the influence of parents' PA on their children's achieving the recommended daily PA is stronger than the inhibitory effect of ST.

  3. The effect of sugar-free versus sugar-sweetened beverages on satiety, liking and wanting: an 18 month randomized double-blind trial in children.

    PubMed

    de Ruyter, Janne C; Katan, Martijn B; Kuijper, Lothar D J; Liem, Djin G; Olthof, Margreet R

    2013-01-01

    Substituting sugar-free for sugar-sweetened beverages reduces weight gain. A possible explanation is that sugar-containing and sugar-free beverages cause the same degree of satiety. However, this has not been tested in long-term trials. We randomized 203 children aged 7-11 years to receive 250 mL per day of an artificially sweetened sugar-free beverage or a similarly looking and tasting sugar-sweetened beverage. We measured satiety on a 5-point scale by questionnaire at 0, 6, 12 and 18 months. We calculated the change in satiety from before intake to 1 minute after intake and 15 minutes after intake. We then calculated the odds ratio that satiety increased by 1 point in the sugar-group versus the sugar-free group. We also investigated how much the children liked and wanted the beverages. 146 children or 72% completed the study. We found no statistically significant difference in satiety between the sugar-free and sugar-sweetened group; the adjusted odds ratio for a 1 point increase in satiety in the sugar group versus the sugar-free group was 0.77 at 1 minute (95% confidence interval, 0.46 to 1.29), and 1.44 at 15 minutes after intake (95% CI, 0.86 to 2.40). The sugar-group liked and wanted their beverage slightly more than the sugar-free group, adjusted odds ratio 1.63 (95% CI 1.05 to 2.54) and 1.65 (95% CI 1.07 to 2.55), respectively. Sugar-sweetened and sugar-free beverages produced similar satiety. Therefore when children are given sugar-free instead of sugar-containing drinks they might not make up the missing calories from other sources. This may explain our previous observation that children in the sugar-free group accumulated less body fat than those in the sugar group. ClinicalTrials.gov NCT00893529 http://clinicaltrials.gov/show/NCT00893529.

  4. Adult height, coronary heart disease and stroke: a multi-locus Mendelian randomization meta-analysis

    PubMed Central

    Nüesch, Eveline; Dale, Caroline; Palmer, Tom M; White, Jon; Keating, Brendan J; van Iperen, Erik PA; Goel, Anuj; Padmanabhan, Sandosh; Asselbergs, Folkert W; Verschuren, WM; Wijmenga, C; Van der Schouw, YT; Onland-Moret, NC; Lange, Leslie A; Hovingh, GK; Sivapalaratnam, Suthesh; Morris, Richard W; Whincup, Peter H; Wannamethe, Goya S; Gaunt, Tom R; Ebrahim, Shah; Steel, Laura; Nair, Nikhil; Reiner, Alexander P; Kooperberg, Charles; Wilson, James F; Bolton, Jennifer L; McLachlan, Stela; Price, Jacqueline F; Strachan, Mark WJ; Robertson, Christine M; Kleber, Marcus E; Delgado, Graciela; März, Winfried; Melander, Olle; Dominiczak, Anna F; Farrall, Martin; Watkins, Hugh; Leusink, Maarten; Maitland-van der Zee, Anke H; de Groot, Mark CH; Dudbridge, Frank; Hingorani, Aroon; Ben-Shlomo, Yoav; Lawlor, Debbie A; Amuzu, A; Caufield, M; Cavadino, A; Cooper, J; Davies, TL; Drenos, F; Engmann, J; Finan, C; Giambartolomei, C; Hardy, R; Humphries, SE; Hypponen, E; Kivimaki, M; Kuh, D; Kumari, M; Ong, K; Plagnol, V; Power, C; Richards, M; Shah, S; Shah, T; Sofat, R; Talmud, PJ; Wareham, N; Warren, H; Whittaker, JC; Wong, A; Zabaneh, D; Davey Smith, George; Wells, Jonathan C; Leon, David A; Holmes, Michael V; Casas, Juan P

    2016-01-01

    Abstract Background: We investigated causal effect of completed growth, measured by adult height, on coronary heart disease (CHD), stroke and cardiovascular traits, using instrumental variable (IV) Mendelian randomization meta-analysis. Methods: We developed an allele score based on 69 single nucleotide polymorphisms (SNPs) associated with adult height, identified by the IBCCardioChip, and used it for IV analysis against cardiovascular risk factors and events in 21 studies and 60 028 participants. IV analysis on CHD was supplemented by summary data from 180 height-SNPs from the GIANT consortium and their corresponding CHD estimates derived from CARDIoGRAMplusC4D. Results: IV estimates from IBCCardioChip and GIANT-CARDIoGRAMplusC4D showed that a 6.5-cm increase in height reduced the odds of CHD by 10% [odds ratios 0.90; 95% confidence intervals (CIs): 0.78 to 1.03 and 0.85 to 0.95, respectively],which agrees with the estimate from the Emerging Risk Factors Collaboration (hazard ratio 0.93; 95% CI: 0.91 to 0.94). IV analysis revealed no association with stroke (odds ratio 0.97; 95% CI: 0.79 to 1.19). IV analysis showed that a 6.5-cm increase in height resulted in lower levels of body mass index (P < 0.001), triglycerides (P < 0.001), non high-density (non-HDL) cholesterol (P < 0.001), C-reactive protein (P = 0.042), and systolic blood pressure (P = 0.064) and higher levels of forced expiratory volume in 1 s and forced vital capacity (P < 0.001 for both). Conclusions: Taller individuals have a lower risk of CHD with potential explanations being that taller people have a better lung function and lower levels of body mass index, cholesterol and blood pressure. PMID:25979724

  5. Occupational exposures and chronic respiratory symptoms: a population-based study

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Korn, R.J.; Dockery, D.W.; Speizer, F.E.

    1987-01-01

    Data from a random sample of 8515 white adults residing in six cities in the eastern and midwestern United States were used to examine the relationships between occupational exposures to dust or to gases and fumes and chronic respiratory symptoms. 31% of the population had a history of occupational dust exposure and 30% reported exposure to gas or to fumes. After adjusting for smoking habits, age, gender, and city of residence, subjects with either occupational exposure had significantly elevated prevalence of chronic cough, chronic phlegm, persistent wheeze, and breathlessness. The adjusted relative odds of chronic respiratory symptoms for subjects exposedmore » to dust ranged from 1.32 to 1.60. Subjects with gas or fume exposure had relative odds of symptoms between 1.27 and 1.43 when compared to unexposed subjects. Occupational dust exposure was associated with a higher prevalence of chronic obstructive pulmonary disease (COPD) as defined by an FEV1/FVC ratio of less than 0.6, when comparing exposed and unexposed participants (OR=1.53, 95% CI=1.17-2.08). Gas or fume exposure was associated with a small, but not significant, increase in COPD prevalence. Significant trends were noted for wheeze and phlegm with increasing duration of dust exposure. Although 36% of exposed subjects reported exposure to both dust and fumes, there was no evidence of a multiplicative interaction between the effects of the individual exposures. Smoking was a significant independent predictor of symptoms, but did not appear to modify the effect of dust or fumes on symptom reporting. These data, obtained in random samples of general populations, demonstrate that chronic respiratory disease can be independently associated with occupational exposures.« less

  6. Occupational exposures and chronic respiratory symptoms. A population-based study

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Korn, R.J.; Dockery, D.W.; Speizer, F.E.

    1987-08-01

    Data from a random sample of 8515 white adults residing in 6 cities in the eastern and midwestern United States were used to examine the relationships between occupational exposures to dust or to gases and fumes and chronic respiratory symptoms; 31% of the population had a history of occupational dust exposure and 30% reported exposure to gas or fumes. After adjusting for smoking habits, age, gender, and city of residence, subjects with either occupational exposure had significantly elevated prevalences of chronic cough, chronic phlegm, persistent wheeze, and breathlessness. The adjusted relative odds of chronic respiratory symptoms for subjects exposed tomore » dust ranged from 1.32 to 1.60. Subjects with gas or fume exposure had relative odds of symptoms between 1.27 and 1.43 when compared with unexposed subjects. Occupational dust exposure was associated with a higher prevalence of chronic obstructive pulmonary disease as defined by an FEV1/FVC ratio of less than 0.6, when comparing exposed and unexposed participants (OR = 1.53, 95% Cl = 1.17-2.08). Gas or fume exposure was associated with a small, but not significant, increase in COPD prevalence. Significant trends were noted for wheeze and phlegm with increasing duration of dust exposure. Although 36% of exposed subjects reported exposure to both dust and fumes, there was no evidence of a multiplicative interaction between the effects of the individual exposures. Smoking was a significant independent predictor of symptoms, but did not appear to modify the effect of dust or fumes on symptom reporting. These data, obtained in random samples of general populations, demonstrate that chronic respiratory symptoms and disease can be independently associated with occupational exposures.« less

  7. Maternal Black Race and Persistent Wheezing Illness in Former Extremely Low Gestational Age Newborns: Secondary Analysis of a Randomized Trial.

    PubMed

    Wai, Katherine C; Hibbs, Anna M; Steurer, Martina A; Black, Dennis M; Asselin, Jeanette M; Eichenwald, Eric C; Ballard, Philip L; Ballard, Roberta A; Keller, Roberta L

    2018-04-04

    To evaluate the relationship between maternal self-reported race/ethnicity and persistent wheezing illness in former high-risk, extremely low gestational age newborns, and to quantify the contribution of socioeconomic, environmental, and biological factors on this relationship. We assessed persistent wheezing illness determined at 18-24 months corrected (for prematurity) age in survivors of a randomized trial. Parents/caregivers were surveyed for wheeze and inhaled asthma medication use quarterly to 12 months, and at 18 and 24 months. We used multivariable analysis to evaluate the relationship of maternal race to persistent wheezing illness, and identified mediators for this relationship via formal mediation analysis. Of 420 infants (25.2 ± 1.2 weeks of gestation and 714 ± 166 g at birth, 57% male, 34% maternal black race), 189 (45%) had persistent wheezing illness. After adjustment for gestational age, birth weight, and sex, infants of black mothers had increased odds of persistent wheeze compared with infants of nonblack mothers (OR = 2.9, 95% CI 1.9, 4.5). Only bronchopulmonary dysplasia, breast milk diet, and public insurance status were identified as mediators. In this model, the direct effect of race accounted for 69% of the relationship between maternal race and persistent wheeze, whereas breast milk diet, public insurance status, and bronchopulmonary dysplasia accounted for 8%, 12%, and 10%, respectively. Among former high-risk extremely low gestational age newborns, infants of black mothers have increased odds of developing persistent wheeze. A substantial proportion of this effect is directly accounted for by race, which may reflect unmeasured environmental influences, and acquired and innate biological differences. ClinicalTrials.gov: NCT01022580. Copyright © 2018 Elsevier Inc. All rights reserved.

  8. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial.

    PubMed

    Bus, Sicco A; Waaijman, Roelof; Arts, Mark; de Haart, Mirjam; Busch-Westbroek, Tessa; van Baal, Jeff; Nollet, Frans

    2013-12-01

    Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence. We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken. On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045). Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.

  9. Gadolinium Enhancement in Intracranial Atherosclerotic Plaque and Ischemic Stroke: A Systematic Review and Meta-Analysis.

    PubMed

    Gupta, Ajay; Baradaran, Hediyeh; Al-Dasuqi, Khalid; Knight-Greenfield, Ashley; Giambrone, Ashley E; Delgado, Diana; Wright, Drew; Teng, Zhongzhao; Min, James K; Navi, Babak B; Iadecola, Costantino; Kamel, Hooman

    2016-08-15

    Gadolinium enhancement on high-resolution magnetic resonance imaging (MRI) has been proposed as a marker of inflammation and instability in intracranial atherosclerotic plaque. We performed a systematic review and meta-analysis to summarize the association between intracranial atherosclerotic plaque enhancement and acute ischemic stroke. We searched the medical literature to identify studies of patients undergoing intracranial vessel wall MRI for evaluation of intracranial atherosclerotic plaque. We recorded study data and assessed study quality, with disagreements in data extraction resolved by a third reader. A random-effects odds ratio was used to assess whether, in any given patient, cerebral infarction was more likely in the vascular territory supplied by an artery with MRI-detected plaque enhancement as compared to territory supplied by an artery without enhancement. We calculated between-study heterogeneity using the Cochrane Q test and publication bias using the Begg-Mazumdar test. Eight articles published between 2011 and 2015 met inclusion criteria. These studies provided information about plaque enhancement characteristics from 295 arteries in 330 patients. We found a significant positive relationship between MRI enhancement and cerebral infarction in the same vascular territory, with a random effects odds ratio of 10.8 (95% CI 4.1-28.1, P<0.001). No significant heterogeneity (Q=11.08, P=0.14) or publication bias (P=0.80) was present. Intracranial plaque enhancement on high-resolution vessel wall MRI is strongly associated with ischemic stroke. Evaluation for plaque enhancement on MRI may be a useful test to improve diagnostic yield in patients with ischemic strokes of undetermined etiology. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  10. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis.

    PubMed

    Sista, Akhilesh K; Miller, Larry E; Kahn, Susan R; Kline, Jeffrey A

    2017-02-01

    Long-term right ventricular (RV) function, functional capacity, exercise capacity, and quality of life following pulmonary embolism (PE), and the impact of thrombolysis, are unclear. A systematic review of studies that evaluated these outcomes with ⩾ 3-month mean follow-up after PE diagnosis was performed. For each outcome, random effects meta-analyses were performed. Twenty-six studies (3671 patients) with 18-month median follow-up were included. The pooled prevalence of RV dysfunction was 18.1%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of RV dysfunction versus those treated with anticoagulation (odds ratio: 0.51, 95% CI: 0.24 to 1.13, p=0.10). Pooled prevalence of at least mild functional impairment (NYHA II-IV) was 33.2%, and at least moderate functional impairment (NYHA III-IV) was 11.3%. Patients treated with thrombolysis had a lower, but not statistically significant, risk of at least moderate functional impairment versus those treated with anticoagulation (odds ratio: 0.48, 95% CI: 0.15 to 1.49, p=0.20). Pooled 6-minute walk distance was 415 m (95% CI: 372 to 458 m), SF-36 Physical Component Score was 44.8 (95% CI: 43 to 46), and Pulmonary Embolism Quality of Life (QoL) Questionnaire total score was 9.1. Main limitations included heterogeneity among studies for many outcomes, variation in the completeness of data reported, and inclusion of data from non-randomized, non-controlled, and retrospective studies. Persistent RV dysfunction, impaired functional status, diminished exercise capacity, and reduced QoL are common in PE survivors. The effect of thrombolysis on RV function and functional status remains unclear.

  11. Calcium/Vitamin D Supplementation and Coronary Artery Calcification

    PubMed Central

    Manson, JoAnn E.; Allison, Matthew A.; Carr, J. Jeffrey; Langer, Robert D.; Cochrane, Barbara B.; Hendrix, Susan L.; Hsia, Judith; Hunt, Julie R.; Lewis, Cora E.; Margolis, Karen L.; Robinson, Jennifer G.; Rodabough, Rebecca J.; Thomas, Asha M.

    2010-01-01

    Objectives Coronary artery calcified plaque is a marker for atheromatous plaque burden and predicts future risk of cardiovascular events. The relationship between calcium plus vitamin D supplementation and coronary artery calcium (CAC) has not been previously assessed in a randomized trial setting. We compared coronary artery calcium scores among women randomized to calcium/vitamin D supplementation versus placebo following trial completion. Methods In an ancillary substudy of women randomized to calcium carbonate (1000 mg of elemental calcium daily) plus vitamin D3 (400 IU daily) versus placebo, nested within the Women’s Health Initiative trial of estrogen among women with hysterectomy, we measured CAC with cardiac computed tomography in 754 women aged 50–59 years at randomization. Imaging for CAC was performed at 28 of 40 centers following a mean of 7 years of treatment and scans were read centrally. Coronary artery calcium scores were measured by a central reading center with masking to randomization assignments. Results Post-trial CAC measurements were similar in women randomized to calcium/vitamin D supplementation (calcium/D) and those receiving placebo. The mean CAC score was 91.6 for calcium/D and 100.5 for placebo (rank test p-value=0.74). After adjustment for coronary risk factors, multivariate odds ratios for increasing CAC score cutpoints (CAC >0, ≥10, and ≥100) for calcium/D vs placebo were 0.92 (95% confidence interval, 0.64–1.34), 1.29 (0.88–1.87), and 0.90 (0.56–1.44), respectively. Corresponding odds ratios among women with >50% adherence to study pills and for higher levels of CAC (>300), were similar. Conclusions Treatment with moderate doses of calcium plus vitamin D3 did not appear to alter coronary artery calcified plaque burden among postmenopausal women. PMID:20551849

  12. Randomized controlled trial of a computer-based module to improve contraceptive method choice.

    PubMed

    Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Ventura, Alicia; Chiasson, Mary Ann

    2012-10-01

    Unintended pregnancy is common in the United States, and interventions are needed to improve contraceptive use among women at higher risk of unintended pregnancy, including Latinas and women with low educational attainment. A three-arm randomized controlled trial was conducted at two family planning sites serving low-income, predominantly Latina populations. The trial tested the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients choosing an effective method of contraception (<10 pregnancies/100 women per year, typical use). Participants were randomized to complete the module and receive tailored health materials, to complete the module and receive generic health materials, or to a control condition. In intent-to-treat analyses adjusted for recruitment site (n=2231), family planning patients who used the module were significantly more likely to choose an effective contraceptive method: 75% among those who received tailored materials [odds ratio (OR)=1.56; 95% confidence interval (CI): 1.23-1.98] and 78% among those who received generic materials (OR=1.74; 95% CI: 1.35-2.25), compared to 65% among control arm participants. The findings support prior research suggesting that patient-centered interventions can positively influence contraceptive method choice. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Health Effects of Exposure to Water-Damaged New Orleans Homes Six Months After Hurricanes Katrina and Rita

    PubMed Central

    Cummings, Kristin J.; Cox-Ganser, Jean; Riggs, Margaret A.; Edwards, Nicole; Hobbs, Gerald R.; Kreiss, Kathleen

    2008-01-01

    Objectives. We investigated the relation between respiratory symptoms and exposure to water-damaged homes and the effect of respirator use in posthurricane New Orleans, Louisiana. Methods. We randomly selected 600 residential sites and then interviewed 1 adult per site. We created an exposure variable, calculated upper respiratory symptom (URS) and lower respiratory symptom (LRS) scores, and defined exacerbation categories by the effect on symptoms of being inside water-damaged homes. We used multiple linear regression to model symptom scores (for all participants) and polytomous logistic regression to model exacerbation of symptoms when inside (for those participating in clean-up). Results. Of 553 participants (response rate=92%), 372 (68%) had participated in clean-up; 233 (63%) of these used a respirator. Respiratory symptom scores increased linearly with exposure (P<.05 for trend). Disposable-respirator use was associated with lower odds of exacerbation of moderate or severe symptoms inside water-damaged homes for URS (odds ratio (OR)=.51; 95% confidence interval (CI)=0.24, 1.09) and LRS (OR=0.33; 95% CI=0.13, 0.83). Conclusions. Respiratory symptoms were positively associated with exposure to water-damaged homes, including exposure limited to being inside without participating in clean-up. Respirator use had a protective effect and should be considered when inside water-damaged homes regardless of activities undertaken. PMID:18381997

  14. CT Bronchus Sign and the Diagnostic Yield of Guided Bronchoscopy for Peripheral Pulmonary Lesions: A Systematic Review and Meta-Analysis.

    PubMed

    Ali, Muhammad S; Sethi, Jaskaran; Taneja, Amit; Musani, Ali; Maldonado, Fabien

    2018-06-07

    Indeterminate peripheral pulmonary lesions often require tissue diagnosis. If non-surgical biopsy techniques are considered, deciding between bronchoscopic transbronchial vs. CT guided transthoracic biopsy can be difficult. The former has a low diagnostic yield with a low complication risk, while the latter has a better diagnostic yield but a higher complication rate. Investigators have looked at various lesion characteristics that can predict the diagnostic yield of guided bronchoscopic biopsies. While consensus exists that larger size and proximity to the hilum increase the diagnostic yield, there is ongoing debate about the association between CT bronchus sign (air-filled bronchus in close proximity of the lesion as seen on CT) and the diagnostic yield of guided bronchoscopic modalities. To perform a meta-analysis and systematic review, determining the association between CT bronchus sign and the diagnostic yield of guided bronchoscopy for peripheral pulmonary lesions. MEDLINE, Embase, Scopus and Google Scholar were searched in January 2018 for guided bronchoscopy studies that had assessed the impact of CT bronchus sign on the diagnostic yield. The quality of included studies was assessed using Quality Assessment, Data Abstraction and Synthesis-2 tool. Meta-analysis was performed using MedCalc (version 18). Odds ratios were used to compare yield of lesions with and without bronchus sign. Random effects model was used when significant heterogeneity was observed (I2>40%). For 2199 lesions with CT bronchus sign, the overall weighted diagnostic yield was 74.1% (95% CI: 68.3-79.5%). For 971 lesions without CT bronchus sign, the overall weighted diagnostic yield was 49.6% (95% CI: 39.6-59.5%). The odds ratio for successfully diagnosing a lesion with CT bronchus was 3.4 (95% CI: 2.4-5.0). Possible sources of heterogeneity in the meta-analysis included differences in study designs, guidance modalities and cancer prevalence. The odds ratio for successfully diagnosing a lesion with CT bronchus sign was relatively lower for prospective studies. Peripheral pulmonary lesions with CT bronchus sign are more likely to be diagnosed with guided bronchoscopy as compared to the lesions without CT bronchus sign. Clinicians should consider this along with the lesion size and distance from hilum, when contemplating guided bronchoscopy for peripheral pulmonary lesions. To perform a meta-analysis and systematic review, determining the impact of CT bronchus sign on the diagnostic yield of guided bronchoscopy for peripheral pulmonary lesions. MEDLINE, Embase, Scopus and Google Scholar were searched in January 2018 for guided bronchoscopy studies that had assessed the impact of CT bronchus sign on the diagnostic yield. The quality of included studies was assessed using Quality Assessment, Data Abstraction and Synthesis-2 tool. Meta-analysis was performed using MedCalc (version 18). Odds ratios were used to compare yield of lesions with and without bronchus sign. Random effects model was used when significant heterogeneity was observed (I2>40%). For 2199 lesions with CT bronchus sign, the overall weighted diagnostic yield was 74.1% (95% CI: 68.3-79.5%). For 971 lesions without CT bronchus, the overall weighted diagnostic yield was 49.6% (95% CI: 39.6-59.5%). The odds ratio for successfully diagnosing a lesion with CT bronchus was 3.4 (95% CI: 2.4-5.0). I² index was 62.1 therefore random effects model was used. Peripheral pulmonary lesions with CT bronchus sign are much more likely to be successfully diagnosed with guided bronchoscopy as compared to the lesions without CT bronchus sign. Clinicians should consider the presence (or absence) of CT bronchus sign along with the size of the lesion and distance from the hilum, when contemplating guided bronchoscopic modalities for peripheral pulmonary lesions.

  15. Peripheral neuropathy in HIV: prevalence and risk factors

    PubMed Central

    Evans, Scott R.; Ellis, Ronald J.; Chen, Huichao; Yeh, Tzu-min; Lee, Anthony J.; Schifitto, Giovanni; Wu, Kunling; Bosch, Ronald J.; McArthur, Justin C.; Simpson, David M.; Clifford, David B.

    2011-01-01

    Objectives To estimate neuropathic sign/symptom rates with initiation of combination antiretroviral therapy (cART) in HIV-infected ART-naive patients, and to investigate risk factors for: peripheral neuropathy and symptomatic peripheral neuropathy (SPN), recovery from peripheral neuropathy/SPN after neurotoxic ART (nART) discontinuation, and the absence of peripheral neuropathy/SPN while on nART. Design AIDS Clinical Trials Group (ACTG) Longitudinal Linked Randomized Trial participants who initiated cART in randomized trials for ART-naive patients were annually screened for symptoms/signs of peripheral neuropathy. ART use and disease characteristics were collected longitudinally. Methods Peripheral neuropathy was defined as at least mild loss of vibration sensation in both great toes or absent/hypoactive ankle reflexes bilaterally. SPN was defined as peripheral neuropathy and bilateral symptoms. Generalized estimating equation logistic regression was used to estimate associations. Results Two thousand, one hundred and forty-one participants were followed from January 2000 to June 2007. Rates of peripheral neuropathy/SPN at 3 years were 32.1/8.6% despite 87.1% with HIV-1RNA 400 copies/ml or less and 70.3% with CD4 greater than 350 cells/µl. Associations with higher odds of peripheral neuropathy included older patient age and current nART use. Associations with higher odds of SPN included older patient age, nART use, and history of diabetes mellitus. Associations with lower odds of recovery after nART discontinuation included older patient age. Associations with higher odds of peripheral neuropathy while on nART included older patient age and current protease inhibitor use. Associations with higher odds of SPN while on nART included older patient age, history of diabetes, taller height, and protease inhibitor use. Conclusion Signs of peripheral neuropathy remain despite virologic/immunologic control but frequently occurs without symptoms. Aging is a risk factor for peripheral neuropathy/SPN. PMID:21330902

  16. Desert bighorn sheep lambing habitat: Parturition, nursery, and predation sites

    USGS Publications Warehouse

    Karsch, Rebekah C.; Cain, James W.; Rominger, Eric M.; Goldstein, Elise J.

    2016-01-01

    Fitness of female ungulates is determined by neonate survival and lifetime reproductive success. Therefore, adult female ungulates should adopt behaviors and habitat selection patterns that enhance survival of neonates during parturition and lactation. Parturition site location may play an important role in neonatal mortality of desert bighorn sheep (Ovis canadensis mexicana) when lambs are especially vulnerable to predation, but parturition sites are rarely documented for this species. Our objectives were to assess environmental characteristics at desert bighorn parturition, lamb nursery, and predation sites and to assess differences in habitat characteristics between parturition sites and nursery group sites, and predation sites and nursery group sites. We used vaginal implant transmitters (VITs) to identify parturition sites and capture neonates. We then compared elevation, slope, terrain ruggedness, and visibility at parturition, nursery, and lamb predation sites with paired random sites and compared characteristics of parturition sites and lamb predation sites to those of nursery sites. When compared to random sites, odds of a site being a parturition site were highest at intermediate slopes and decreased with increasing female visibility. Odds of a site being a predation site increased with decreasing visibility. When compared to nursery group sites, odds of a site being a parturition site had a quadratic relationship with elevation and slope, with odds being highest at intermediate elevations and intermediate slopes. When we compared predation sites to nursery sites, odds of a site being a predation were highest at low elevation areas with high visibility and high elevation areas with low visibility likely because of differences in hunting strategies of coyote (Canis latrans) and puma (Puma concolor). Parturition sites were lower in elevation and slope than nursery sites. Understanding selection of parturition sites by adult females and how habitat characteristics at these sites differ from those at predation and nursery sites can provide insight into strategies employed by female desert bighorn sheep and other species during and after parturition to promote neonate survival.

  17. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia.

    PubMed

    Studts, Christina R; Tarasenko, Yelena N; Schoenberg, Nancy E; Shelton, Brent J; Hatcher-Keller, Jennifer; Dignan, Mark B

    2012-06-01

    Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years). This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005-June 2008). Women aged 40-64 and overdue for screening were recruited from churches and individually randomized to treatment (n=176) or wait-list control (n=169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95% CI: 1.03-6.38, p=0.04. Independent of group, recently screened participants (last Pap >1 but <5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5 years ago), OR=2.50, 95% CI: 1.48-4.25, p=0.001. The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. A community-based randomized trial of a faith-placed intervention to reduce cervical cancer burden in Appalachia

    PubMed Central

    Studts, Christina R.; Tarasenko, Yelena N.; Schoenberg, Nancy E.; Shelton, Brent J.; Hatcher-Keller, Jennifer; Dignan, Mark B.

    2012-01-01

    Objective Faith Moves Mountains assessed the effectiveness of a faith-placed lay health advisor (LHA) intervention to increase Papanicolaou (Pap) test use among middle-aged and older women in a region disproportionately affected by cervical cancer and low screening rates (regionally, only 68% screened in prior 3 years). Method This community-based RCT was conducted in four Appalachian Kentucky counties (December 2005 – June 2008). Women aged 40–64 and overdue for screening were recruited from churches and individually randomized to treatment (n=176) or wait-list control (n=169). The intervention provided LHA home visits and newsletters addressing barriers to screening. Self-reported Pap test receipt was the primary outcome. Results Intention-to-treat analyses revealed that treatment group participants (17.6% screened) had over twice the odds of wait-list controls (11.2% screened) of reporting Pap test receipt post-intervention, OR=2.56, 95%CI: 1.03–6.38, p=0.04. Independent of group, recently screened participants (last Pap >1 but <5 years ago) had significantly higher odds of obtaining screening during the study than rarely or never screened participants (last Pap ≥5 years ago), OR=2.50, 95%CI: 1.48–4.25, p=0.001. Conclusions The intervention was associated with increased cervical cancer screening. The faith-placed LHA addressing barriers comprises a novel approach to reducing cervical cancer disparities among Appalachian women. PMID:22498022

  19. Use of face masks by non-scrubbed operating room staff: a randomized controlled trial.

    PubMed

    Webster, Joan; Croger, Sarah; Lister, Carolyn; Doidge, Michelle; Terry, Michael J; Jones, Ian

    2010-03-01

    Ambiguity remains about the effectiveness of wearing surgical face masks. The purpose of this study was to assess the impact on surgical site infections (SSIs) when non-scrubbed operating room staff did not wear surgical face masks. Eight hundred twenty-seven participants undergoing elective or emergency obstetric, gynecological, general, orthopaedic, breast or urological surgery in an Australian tertiary hospital were enrolled. Complete follow-up data were available for 811 patients (98.1%). Operating room lists were randomly allocated to a 'Mask group' (all non-scrubbed staff wore a mask) or 'No Mask group' (none of the non-scrubbed staff wore masks). The primary end point, SSI was identified using in-patient surveillance; post discharge follow-up and chart reviews. The patient was followed for up to six weeks. Overall, 83 (10.2%) surgical site infections were recorded; 46/401 (11.5%) in the Masked group and 37/410 (9.0%) in the No Mask group; odds ratio (OR) 0.77 (95% confidence interval (CI) 0.49 to 1.21), p = 0.151. Independent risk factors for surgical site infection included: any pre-operative stay (adjusted odds ratio [aOR], 0.43 (95% CI, 0.20; 0.95), high BMI aOR, 0.38 (95% CI, 0.17; 0.87), and any previous surgical site infection aOR, 0.40 (95% CI, 0.17; 0.89). Surgical site infection rates did not increase when non-scrubbed operating room personnel did not wear a face mask.

  20. Education, Employment, Income, and Marital Status Among Adults Diagnosed With Inflammatory Bowel Diseases During Childhood or Adolescence.

    PubMed

    El-Matary, Wael; Dufault, Brenden; Moroz, Stan P; Schellenberg, Jeannine; Bernstein, Charles N

    2017-04-01

    We aimed to assess levels of education attained, employment, and marital status of adults diagnosed with inflammatory bowel diseases (IBD) during childhood or adolescence, compared with healthy individuals in Canada. We performed a cross-sectional study of adults diagnosed with IBD in childhood or adolescence at Children's Hospital in Winnipeg, Manitoba from January 1978 through December 2007. Participants (n = 112) answered a semi-structured questionnaire on educational achievements, employment, and marital status. Patients were matched for age and sex with random healthy individuals from the 2012 Canadian Community Health Survey (controls, 5 per patient). Conditional binary logistic regression and random-effects ordinal logistic regression models were used for analysis. Patients were followed for a mean duration of 14.3 years (range, 3.1-34.5 years). Persons with IBD were more likely to earn more money per annum and attain a post-secondary school degree or receive a diploma than controls (odds ratio, 1.72; 95% confidence interval, 1.13-2.60; P < .01 and odds ratio, 2.73; 95% confidence interval, 1.48-5.04; P < .01, respectively). There was no significant difference between patients and controls in employment or marital status. Adults diagnosed with IBD during childhood seem to achieve higher education levels than individuals without IBD. This observation should provide reassurance to children with IBD and their parents. ClinicalTrials.gov number: NCT02152241. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  1. Wireless Phone Use and Risk of Adult Glioma: Evidence from a Meta-Analysis.

    PubMed

    Wang, Peng; Hou, Chongxian; Li, Yanwen; Zhou, Dong

    2018-04-28

    Wireless phone use has been increasing rapidly and is associated with the risk of glioma. Many studies have been conducted on this association without reaching agreement. The aim of this meta-analysis was to determine the possible association between wireless phone use and risk of adult glioma. Eligible studies were identified by searching PubMed and Embase up to July 2017. Random-effects or fixed-effects model was used to combine the results depending on the heterogeneity of the analysis. Publication bias was evaluated using Begg's funnel plot and Egger's regression asymmetry test. Subgroup analysis was performed to evaluate possible influence of these variables. Ten studies on the association of wireless phone use and risk of glioma were included. The combined odds ratio of adult gliomas associated with ever use of wireless phones was 1.03 (95% confidence interval [CI], 0.92-1.16) with high heterogeneity (I 2  = 54.2%, P = 0.013). In subgroup analyses, no significant association was found between tumor location in the temporal lobe and adult glioma risk, with odds ratios of 1.26 (95% CI, 0.87-1.84), 0.93 (95% CI, 0.69-1.24), and 1.61 (95% CI, 0.78-3.33). A significant association with risk of glioma was found in long-term users (≥10 years) with odds ratio of 1.33 (95% CI, 1.05-1.67). Ever use of wireless phones was not significantly associated with risk of adult glioma, but there could be increased risk in long-term users. Copyright © 2018 Elsevier Inc. All rights reserved.

  2. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis.

    PubMed

    Lowe, John; Watkins, W John; Edwards, Martin O; Spiller, O Brad; Jacqz-Aigrain, Evelyne; Kotecha, Sarah J; Kotecha, Sailesh

    2014-07-01

    Previous meta-analyses have reported a significant association between pulmonary colonization with Ureaplasma and development of bronchopulmonary dysplasia (BPD). However, because few studies reporting oxygen dependency at 36 weeks corrected gestation were previously available, we updated the systematic review and meta-analyses to evaluate the association between presence of pulmonary Ureaplasma and development of BPD. Five databases were searched for articles reporting the incidence of BPD at 36 weeks postmenstrual age (BPD36) and/or BPD at 28 days of life (BPD28) in Ureaplasma colonized and noncolonized groups. Pooled estimates were produced using random effects meta-analysis. Meta-regression was used to assess the influence of difference in gestational age between the Ureaplasma-positive and Ureaplasma-negative groups. The effects of potential sources of heterogeneity were also investigated. Of 39 studies included, 8 reported BPD36, 22 reported BPD28 and 9 reported both. The quality of studies was assessed as moderate to good. There was a significant association between Ureaplasma and development of BPD36 (odds ratio = 2.22; 95% confidence intervals: 1.42-3.47) and BPD28 (odds ratio = 3.04; 95% confidence intervals: 2.41-3.83). Sample size influenced the odds ratio, but no significant association was noted between BPD28 rates and difference in gestational age between Ureaplasma colonized and noncolonized infants (P = 0.96). Pulmonary colonization with Ureaplasma continues to be significantly associated with development of BPD in preterm infants at both 36 weeks postmenstrual age and at 28 days of life. This association at BPD28 persists regardless of difference in gestational age.

  3. The effect of community-based reproductive health communication interventions on contraceptive use among young married couples in Bihar, India.

    PubMed

    Daniel, Elkan E; Masilamani, Rekha; Rahman, Mizanur

    2008-12-01

    Contraceptive use among young couples in India is low, and early childbearing and short birth intervals are common. The PRACHAR Project, an ongoing intervention in Bihar, seeks to increase contraceptive use for delaying and spacing births through communication interventions. Random samples of married women younger than 25 with no more than one child were surveyed in 2002-2003, before PRACHAR was implemented (N=1,995), and in 2004, 21-27 months after implementation (N=2,080). Contraceptive demand and use, and related attitudes and knowledge, were assessed in the two surveys in both intervention areas and comparison areas. Logistic regression was used to assess the effect of the interventions on these indicators. Contraceptive use was very low (2-6%) at baseline in both comparison and intervention areas. Demand for contraception increased from 25% at baseline to 40% at follow-up in intervention areas, but remained virtually unchanged in comparison areas. At follow-up, contraceptive use had risen in both areas, but the adjusted odds of use in intervention areas were 3.8 times those in comparison areas. Women in intervention areas had elevated odds of knowing that fertility varies during the menstrual cycle, and of agreeing that early childbirth can be harmful and that contraceptive use is necessary and safe for delaying first births (odds ratios, 1.6-3.0). Culturally appropriate, community-based communication programs that target youth and those who influence their decisions can create demand for contraception among young couples and lead to increased contraceptive use.

  4. Get Fit with the Grizzlies: a community-school-home initiative to fight childhood obesity.

    PubMed

    Irwin, Carol C; Irwin, Richard L; Miller, Maureen E; Somes, Grant W; Richey, Phyllis A

    2010-07-01

    Professional sport organizations in the United States have notable celebrity status, and several teams have used this "star power" to collaborate with local school districts toward the goal of affecting children's health. Program effectiveness is unknown due to the absence of comprehensive evaluations for these initiatives. The Memphis Grizzlies, the city's National Basketball Association franchise, launched "Get Fit with the Grizzlies," a 6-week, curricular addition focusing on nutrition and physical activity for the fourth and fifth grades in Memphis City Schools (MCS). The health-infused mini-unit was delivered by physical education teachers during their classes. The purpose of this study was to evaluate the "Get Fit" program effectiveness. Survey research was employed which measured health knowledge acquisition and health behavior change using a matched pre/posttest design in randomly chosen schools (n = 11) from all elementary schools in the MCS system (N = 110). The total number of matched pre/posttests (n = 888) equaled approximately 5% of the total fourth-/fifth-grade population. McNemar's test for significance (p < .05) was applied. Odds ratios were calculated for each question. Analyses confirmed that there was significant health knowledge acquisition (7 of 8 questions) with odds ratios confirming moderate to strong associations. Seven out of 10 health behavior change questions significantly improved after intervention, whereas odds ratios indicated a low level of association after intervention. This community-school-home initiative using a professional team's celebrity platform within a certain locale is largely overlooked by school districts and should be considered as a positive strategy to confront childhood obesity.

  5. Effect of Pharmacy-Supported Transition-of-Care Interventions on 30-Day Readmissions: A Systematic Review and Meta-analysis.

    PubMed

    Rodrigues, Claire R; Harrington, Amanda R; Murdock, Nicole; Holmes, John T; Borzadek, Eliza Z; Calabro, Kristin; Martin, Jennifer; Slack, Marion K

    2017-10-01

    To describe pharmacy-supported transition-of-care (TOC) interventions and determine their effect on 30-day all-cause readmissions. MEDLINE/PubMed, EMBASE, International Pharmaceutical Abstracts, ABI Inform Complete, PsychINFO, Web of Science, Academic Search Complete, CINHAL, Cochrane library, OIASTER, ProQuest Dissertations & Theses, ClinicalTrials.gov , and relevant websites were searched from January 1, 1995, to December 31, 2015. PICOS+E criteria were utilized. Eligible studies reported pharmacy-supported TOC interventions compared with usual care in adult patients discharged to home within the United States. Studies were required to evaluate postdischarge outcomes (eg, rate of readmissions, hospital utilization). Randomized controlled trials, cohort studies, or controlled before-and-after studies were included. Two reviewers independently extracted data and evaluated study quality. A total of 56 articles were included in the systematic review (n = 61 858), of which 32 reported 30-day all-cause readmissions and were included in the meta-analysis. A taxonomy was developed to categorize targeted patients, intervention types, and pharmacy personnel as sole intervener. The meta-analysis demonstrated about a 32% reduction in the odds of readmission (odds ratio [OR] = 0.68; 95% CI = 0.61 to 0.75) observed for pharmacy-supported TOC interventions compared with usual care. Heterogeneity was identified ( I 2 = 55%; P < 0.001). A stratified meta-analysis showed that interventions with patient-centered follow-up reduced 30-day readmissions relative to studies without follow-up (OR = 0.70; CI = 0.63 to 0.78). Pharmacy-supported TOC programs were associated with a significant reduction in the odds of 30-day readmissions.

  6. Understanding the effect of ethnic density on mental health: multi-level investigation of survey data from England.

    PubMed

    Das-Munshi, Jayati; Becares, Laia; Dewey, Michael E; Stansfeld, Stephen A; Prince, Martin J

    2010-10-21

    To determine if living in areas where higher proportions of people of the same ethnicity reside is protective for common mental disorders, and associated with a reduced exposure to discrimination and improved social support. Finally, to determine if any protective ethnic density effects are mediated by reduced exposure to racism and improved social support. Multi-level logistic regression analysis of national survey data, with area-level, own-group ethnic density modelled as the main exposure. Participants and setting 4281 participants of Irish, black Caribbean, Indian, Pakistani, Bangladeshi, and white British ethnicity, aged 16-74 years, randomly sampled from 892 "middle layer super output areas" in England. Common mental disorders (assessed via structured interviews); discrimination (assessed via structured questionnaire); and social support and social networks (assessed via structured questionnaire). Although the most ethnically dense areas were also the poorest, for each 10 percentage point increase in own-group ethnic density, there was evidence of a decreased risk of common mental disorders, for the full ethnic minority sample (odds ratio 0.94 (95% confidence interval 0.89 to 0.99); P=0.02, trend), for the Irish group (odds ratio 0.21 (0.06 to 0.74); P=0.01, trend), and for the Bangladeshi group (odds ratio 0.75 (0.62 to 0.91); P=0.005, trend), after adjusting for a priori confounders. For some groups, living in areas of higher own-group density was associated with a reduction in the reporting of discrimination and with improved social support and improved social networks. However, none of these factors mediated ethnic density effects. A protective effect of living in areas of higher own-group ethnic density was present for common mental disorders for some minority groups. People living in areas of higher own-group density may report improved social support and less discrimination, but these associations did not fully account for density effects.

  7. A double-blind randomized controlled trial of N-acetylcysteine in cannabis-dependent adolescents

    PubMed Central

    Gray, Kevin M.; Carpenter, Matthew J.; Baker, Nathaniel L.; DeSantis, Stacia M.; Kryway, Elisabeth; Hartwell, Karen J.; McRae-Clark, Aimee L.; Brady, Kathleen T.

    2012-01-01

    Objective Preclinical findings suggest that the over-the-counter supplement N-acetylcysteine, via glutamate modulation in the nucleus accumbens, holds promise as a pharmacotherapy targeting substance dependence. We sought to investigate N-acetylcysteine as a novel cannabis cessation treatment in adolescents, a vulnerable group for whom existing treatments have limited efficacy. Method In this 8-week double-blind randomized placebo-controlled trial, treatment-seeking cannabis-dependent adolescents (age 15-21, N = 116) received N-acetylcysteine (1200 mg) or placebo twice daily, each added to a contingency management intervention and brief (≤10 minute) weekly cessation counseling. The primary efficacy measure was the odds of negative weekly urine cannabinoid tests during treatment among participants receiving N-acetylcysteine versus placebo, via intent-to-treat analysis. The primary tolerability measure was frequency of adverse events, compared by treatment group. Results N-acetylcysteine was well tolerated with minimal adverse events. N-acetylcysteine participants had more than twice the odds, compared to placebo participants, of submitting negative urine cannabinoid tests during treatment (odds ratio = 2.4, [95% CI: 1.1-5.2], p = 0.029). Exploratory secondary abstinence outcomes numerically favored N-acetylcysteine, but were not statistically significant. Conclusions This is the first randomized trial of pharmacotherapy for cannabis dependence in any age group yielding a positive primary cessation outcome via intent-to-treat analysis. Findings support N-acetylcysteine as a pharmacotherapy to complement psychosocial treatment for cannabis dependence in adolescents. Further research is needed to replicate these findings and explore the efficacy of N-acetylcysteine across a variety of treatment contexts and outcomes. Trial Registration clinicaltrials.gov identifier: NCT 01005810 PMID:22706327

  8. Enteral and parenteral nutrition in the conservative treatment of pancreatic fistula: a randomized clinical trial.

    PubMed

    Klek, Stanislaw; Sierzega, Marek; Turczynowski, Lukasz; Szybinski, Piotr; Szczepanek, Kinga; Kulig, Jan

    2011-07-01

    Postoperative pancreatic fistula is the most common and potentially life-threatening complication after pancreatic surgery. Although nutritional support is a key component of conservative therapy in such cases, there have been no well-designed clinical trials substantiating the superiority of either total parenteral nutrition or enteral nutrition. This study was conducted to compare the efficacy and safety of both routes of nutritional intervention. A randomized clinical trial was conducted in a tertiary surgical center of pancreatic and gastrointestinal surgery. Seventy-eight patients with postoperative pancreatic fistula were treated conservatively and randomly assigned to groups receiving for 30 days either enteral nutrition or total parenteral nutrition. The primary end point was the 30-day fistula closure rate. After 30 days, closure rates in patients receiving enteral and parenteral nutrition were 60% (24 of 40) and 37% (14 of 38), respectively (P=.043). The odds ratio for the probability that fistula closes on enteral nutrition compared to total parenteral nutrition was 2.571 (95% confidence interval [CI]: 1.031-6.411). Median time to closure was 27 days (95% CI: 21-33) for enteral nutrition, and no median time was reached in total parenteral nutrition (P=.047). A logistic regression analysis identified only 2 factors significantly associated with fistula closure, ie, enteral nutrition (odds ratio=6.136; 95% CI: 1.204-41.623; P=.043) and initial fistula output of ≤200 mL/day (odds ratio=12.701; 95% CI: 9.102-47.241; P<.001). Enteral nutrition is associated with significantly higher closure rates and shorter time to closure of postoperative pancreatic fistula. Copyright © 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.

  9. Offering self-administered oral HIV testing to truck drivers in Kenya to increase testing: a randomized controlled trial.

    PubMed

    Kelvin, Elizabeth A; George, Gavin; Mwai, Eva; Nyaga, Eston; Mantell, Joanne E; Romo, Matthew L; Odhiambo, Jacob O; Starbuck, Lila; Govender, Kaymarlin

    2018-01-01

    We conducted a randomized controlled trial among 305 truck drivers from two North Star Alliance roadside wellness clinics in Kenya to see if offering HIV testing choices would increase HIV testing uptake. Participants were randomized to be offered (1) a provider-administered rapid blood (finger-prick) HIV test (i.e., standard of care [SOC]) or (2) a Choice between SOC or a self-administered oral rapid HIV test with provider supervision in the clinic. Participants in the Choice arm who refused HIV testing in the clinic were offered a test kit for home use with phone-based posttest counseling. We compared HIV test uptake using the Mantel Haenszel odds ratio (OR) adjusting for clinic. Those in the Choice arm had higher odds of HIV test uptake than those in the SOC arm (OR = 1.5), but the difference was not statistically significant (p = 0.189). When adding the option to take an HIV test kit for home use, the Choice arm had significantly greater odds of testing uptake (OR = 2.8, p = 0.002). Of those in the Choice arm who tested, 26.9% selected the SOC test, 64.6% chose supervised self-testing in the clinic, and 8.5% took a test kit for home use. Participants varied in the HIV test they selected when given choices. Importantly, when participants who refused HIV testing in the clinic were offered a test kit for home use, an additional 8.5% tested. Offering truck drivers a variety of HIV testing choices may increase HIV testing uptake in this key population.

  10. Hands4U: the effects of a multifaceted implementation strategy on hand eczema prevalence in a healthcare setting. Results of a randomized controlled trial.

    PubMed

    van der Meer, Esther W C; Boot, Cécile R L; van der Gulden, Joost W J; Knol, Dirk L; Jungbauer, Frank H W; Coenraads, Pieter Jan; Anema, Johannes R

    2015-05-01

    Healthcare workers have an increased risk of developing hand eczema. A multifaceted implementation strategy was developed to implement a guideline to prevent hand eczema among healthcare workers. To investigate the effects of the implementation strategy on self-reported hand eczema and preventive behaviour. A randomized controlled trial was performed. A total of 48 departments (n = 1649) were randomly allocated to the multifaceted implementation strategy or the control group. The strategy consisted of education, participatory working groups, and role models. Outcome measures were self-reported hand eczema and preventive behaviour. Data were collected at baseline, and 3, 6, 9 and 12 months of follow-up. Participants in the intervention group were significantly more likely to report hand eczema [odds ratio (OR) 1.45; 95% confidence interval (CI) 1.03-2.04], and they reported significantly less hand washing (B, - 0.38; 95%CI: - 0.48 to - 0.27), reported significantly more frequent use of a moisturizer (B, 0.30; 95%CI: 0.22-0.39) and were more likely to report wearing cotton undergloves (OR 6.33; 95%CI: 3.23-12.41) than participants in the control group 12 months after baseline. The strategy implemented can be used in practice, as it showed positive effects on preventive behaviour. More research is needed to investigate the unexpected effects on hand eczema. © 2014 The Authors. Contact Dermatitis published by John Wiley & Sons Ltd.

  11. Applying the Transtheoretical Model to evaluate the effect of a call-recall program in enhancing Pap smear practice: a cluster randomized trial.

    PubMed

    Abdullah, Fauziah; Su, Tin Tin

    2013-01-01

    The objective of this study was to evaluate the effect of a call-recall approach in enhancing Pap smear practice by changes of motivation stage among non-compliant women. A cluster randomized controlled trial with parallel and un-blinded design was conducted between January and November 2010 in 40 public secondary schools in Malaysia among 403 female teachers who never or infrequently attended for a Pap test. A cluster randomization was applied in assigning schools to both groups. An intervention group received an invitation and reminder (call-recall program) for a Pap test (20 schools with 201 participants), while the control group received usual care from the existing cervical screening program (20 schools with 202 participants). Multivariate logistic regression was performed to determine the effect of the intervention program on the action stage (Pap smear uptake) at 24 weeks. In both groups, pre-contemplation stage was found as the highest proportion of changes in stages. At 24 weeks, an intervention group showed two times more in the action stage than control group (adjusted odds ratio 2.44, 95% CI 1.29-4.62). The positive effect of a call-recall approach in motivating women to change the behavior of screening practice should be appreciated by policy makers and health care providers in developing countries as an intervention to enhance Pap smear uptake. Copyright © 2013 Elsevier Inc. All rights reserved.

  12. Surface electrical stimulation in dysphagic Parkinson patients: a randomized clinical trial.

    PubMed

    Baijens, Laura W J; Speyer, Renée; Passos, Valéria Lima; Pilz, Walmari; van der Kruis, Jolien; Haarmans, Saskia; Desjardins-Rombouts, Christel

    2013-11-01

    A new treatment for oropharyngeal dysphagia in Parkinson's disease was evaluated in the present study. Prospective randomized controlled trial. The study describes the effects of surface electrical stimulation (SES) of the neck (submental region) in dysphagic Parkinson patients using different intensities of electrical current. Quasi-random allocation was performed when assigning patients to treatment groups. Three groups consisting of dysphagic patients with idiopathic Parkinson's disease (N = 90) received daily treatment for 15 days with periods of no treatment during the weekend. All three received traditional logopedic dysphagia treatment. In addition, two groups received SES, either motor-level or sensory-level stimulation. A standardized measurement protocol, including fiber optic endoscopic evaluation of swallowing (FEES) and videofluoroscopy of swallowing (VFS), was performed before and after therapy. A team of experienced raters was blinded to the treatment group and to the moment of measurement. Intrarater and interrater reliability were calculated. Using proportional odds models (POMs), some of the visuoperceptual ordinal outcome variables showed significant improvement in all groups following treatment. Following 15 days of SES of the submental region, few significant effects were found, suggesting a therapy effect of traditional logopedic dysphagia treatment without any additional influence of SES. On the grounds of this study, it is concluded that further research is needed on the exact mechanism of SES and its effects on the neural pathways involved in swallowing. Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

  13. Family Group Cognitive-Behavioral Preventive Intervention for Families of Depressed Parents: 18- and 24-month Outcomes

    PubMed Central

    Compas, Bruce E.; Forehand, Rex; Thigpen, Jennifer C.; Keller, Gary; Hardcastle, Emily J.; Cole, David A.; Potts, Jennifer; Haker, Kelly; Rakow, Aaron; Colletti, Christina; Reeslund, Kristen; Fear, Jessica; Garai, Emily; McKee, Laura; Merchant, M.J.; Roberts, Lorinda

    2014-01-01

    Objective In a long-term follow-up of a randomized controlled trial (Compas et al., 2009), to examine the effects at 18- and 24-month follow-ups of a Family Group Cognitive Behavioral (FGCB) preventive intervention for mental health outcomes for children and parents from families (N = 111) of parents with a history of major depressive disorder (MDD). Method Parents with a history of MDD and their 9 to 15-year-old children were randomly assigned to a FGCB intervention or a Written Information (WI) comparison condition. Children’s internalizing, externalizing, anxiety/depression, and depressive symptoms, episodes of MDD and other psychiatric diagnoses, and parents’ depressive symptoms and episodes of MDD were assessed at 18- and 24-months after randomization. Results Children in the FGCB condition were significantly lower in self-reports of anxiety/depression and internalizing symptoms at 18-months and significantly lower in externalizing symptoms at 18- and 24-months. Rates of MDD were significantly lower for children in the FGCB intervention over the 24-month follow-up (odds ratio = 2.91). No significant effects were found for parents’ symptoms of depression or episodes of MDD. Conclusions Support was found for a FGCB preventive intervention for children of parents with a history of MDD significantly reducing children’s episodes of MDD over a period of 2 years. Significant effects for the FGCB intervention were also found on internalizing and externalizing symptoms, with stronger effects at 18- than at 24-month follow-up. PMID:21707137

  14. Family group cognitive-behavioral preventive intervention for families of depressed parents: 18- and 24-month outcomes.

    PubMed

    Compas, Bruce E; Forehand, Rex; Thigpen, Jennifer C; Keller, Gary; Hardcastle, Emily J; Cole, David A; Potts, Jennifer; Watson, Kelly H; Rakow, Aaron; Colletti, Christina; Reeslund, Kristen; Fear, Jessica; Garai, Emily; McKee, Laura; Merchant, M J; Roberts, Lorinda

    2011-08-01

    In a long-term follow-up of a randomized controlled trial (Compas et al., 2009) to examine the effects at 18- and 24-month follow-ups of a family group cognitive-behavioral (FGCB) preventive intervention for mental health outcomes for children and parents from families (N = 111) of parents with a history of major depressive disorder (MDD). Parents with a history of MDD and their 9- to 15-year-old children were randomly assigned to a FGCB intervention or a written information comparison condition. Children's internalizing, externalizing, anxiety/depression, and depressive symptoms; episodes of MDD and other psychiatric diagnoses; and parents' depressive symptoms and episodes of MDD were assessed at 18 and 24 months after randomization. Children in the FGCB condition were significantly lower in self-reports of anxiety/depression and internalizing symptoms at 18 months and were significantly lower in self-reports of externalizing symptoms at 18 and 24 months. Rates of MDD were significantly lower for children in the FGCB intervention over the 24-month follow-up (odds ratio = 2.91). Marginal effects were found for parents' symptoms of depression at 18 and 24 months but not for episodes of MDD. Support was found for a FGCB preventive intervention for children of parents with a history of MDD significantly reducing children's episodes of MDD over a period of 2 years. Significant effects for the FGCB intervention were also found on internalizing and externalizing symptoms, with stronger effects at 18- than at 24-month follow-up.

  15. Genetically predicted milk consumption and bone health, ischemic heart disease and type 2 diabetes: a Mendelian randomization study.

    PubMed

    Yang, Q; Lin, S L; Au Yeung, S L; Kwok, M K; Xu, L; Leung, G M; Schooling, C M

    2017-08-01

    Milk provides protein and micronutrients, and is recommended by some dietary guidelines, particularly for bone health. Meta-analysis of small randomized controlled trials suggests that milk may increase bone mineral density, but they are very heterogeneous. No randomized controlled trial has assessed the effects of milk on major chronic diseases. Previous Mendelian randomization studies of milk did not consider bone health, found no effects on ischemic heart disease (IHD) or type 2 diabetes (T2D) but higher body mass index. Using larger genetic studies, we estimated the effects of milk on osteoporosis, IHD, T2D, adiposity, lipids and glycemic traits. Instrumental variable analysis based on a genetic variant endowing lactase persistence (rs4988235 (MCM6)) was used to obtain estimates for osteoporosis (GEFOS), IHD (CARDIoGRAMplusC4D), T2D (DIAGRAM), adiposity (GIANT), lipids (GLGC) and glycaemic traits (MAGIC). Eye color was a negative control for IHD, as it mirrors the distribution of lactase persistence and IHD in Western Europe. Genetically predicted adult milk consumption was not clearly associated with bone mineral density, IHD (odds ratio (OR): 1.03 per s.d., 95% confidence interval (CI): 0.95-1.12) and or T2D (OR: 0.92, 95% CI: 0.83-1.02) but was associated with higher log-transformed fasting insulin (0.05, 95% CI: 0.02-0.07) and body mass index (0.06, 95% CI: 0.03-0.09). Genetically predicted eye color was not associated with IHD. The lack of association of genetically predicted milk consumption with bone health, IHD or T2D suggests few beneficial effects but is more consistent with milk promoting adiposity.

  16. Effects of a Clinician Referral and Exercise Program for Men Who Have Completed Active Treatment for Prostate Cancer: A Multicenter Cluster Randomized Controlled Trial (ENGAGE)

    PubMed Central

    Livingston, Patricia M; Craike, Melinda J; Salmon, Jo; Courneya, Kerry S; Gaskin, Cadeyrn J; Fraser, Steve F; Mohebbi, Mohammadreza; Broadbent, Suzanne; Botti, Mari; Kent, Bridie

    2015-01-01

    BACKGROUND The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer. METHODS This was a multicenter cluster randomized controlled trial in Melbourne, Australia comprising 15 clinicians: 8 clinicians were randomized to refer eligible participants (n = 54) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week, and 7 clinicians were randomized to follow usual care (n = 93). The primary outcome was self-reported physical activity; the secondary outcomes were quality of life, anxiety, and symptoms of depression. RESULTS A significant intervention effect was observed for vigorous-intensity exercise (effect size: Cohen's d, 0.46; 95% confidence interval [CI], 0.09-0.82; P = .010) but not for combined moderate and vigorous exercise levels (effect size: d, 0.08; 95% CI, −0.28 to 0.45; P = .48). Significant intervention effects were also observed for meeting exercise guidelines (≥150 min/wk; odds ratio, 3.9; 95% CI, 1.9-7.8; P = .002); positive intervention effects were observed in the intervention group for cognitive functioning (effect size: d, 0.34; 95% CI, −0.02 to 0.70; P = .06) and depression symptoms (effect size: d, −0.35; 95% CI, −0.71 to 0.02; P = .06). Eighty percent of participants reported that the clinician's referral influenced their decision to participate in the exercise program. CONCLUSIONS The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer. Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations. Cancer 2015;121:2646–2654. © 2015 American Cancer Society. PMID:25877784

  17. 'Scared Straight' and other juvenile awareness programs for preventing juvenile delinquency.

    PubMed

    Petrosino, Anthony; Turpin-Petrosino, Carolyn; Hollis-Peel, Meghan E; Lavenberg, Julia G

    2013-04-30

    'Scared Straight' and other similar programs involve organized visits to prison by juvenile delinquents or children at risk for criminal behavior. Programs are designed to deter participants from future offending through first hand observation of prison life and interaction with adult inmates. These programs remain in use despite research questioning their effectiveness. This is an update of a 2002 review. To assess the effects of programs comprising organized visits to prisons by juvenile delinquents (officially adjudicated, that is, convicted by a juvenile court) or pre-delinquents (children in trouble but not officially adjudicated as delinquents), aimed at deterring them from delinquency. To update this review, we searched 22 electronic databases, including CENTRAL, MEDLINE, PsycINFO, and Criminal Justice Abstracts, in December 2011. In addition, we searched clinical trials registries, consulted experts, conducted Google Scholar searches,and followed up on all relevant citations. We included studies that tested programs involving the organized visits of delinquents or children at risk for delinquency to penal institutions such as prisons or re formatives. Studies that had overlapping samples of juvenile and young adults (for example, ages 14 to 20 years) were included. We only considered studies that assigned participants to conditions randomly or quasi-randomly (that is,by odd/even assignment to conditions). Each study had to have a no-treatment control condition and at least one outcome measure of 'post-visit' criminal behavior. The search methods for the original review generated 487 citations, most of which had abstracts. The lead review author screened these citations, determining that 30 were evaluation reports. Two review authors independently examined these citations and agreed that 11 were potential randomized trials. All reports were obtained. Upon inspection of the full-text reports, two review authors independently agreed to exclude two studies, resulting in nine randomized trials. The lead review author extracted data from each of the nine study reports using a specially designed instrument. In cases in which outcome information was missing from the original reports, we made attempts via correspondence to retrieve the data for the analysis from the original investigators. Outcome data were independently checked by a second review author (CTP).In this review, we report the results of each of the nine trials narratively.We conducted two meta-analyses of seven studies that provided post intervention offending rates using official data. Information from other sources (for example, self-report) was either missing from some studies or critical information was omitted (for example, standard deviations).We examined the immediate post-treatment effects(that is, 'first-effects') by computing odds ratios (OR) for data on proportions of each group re offending, and assumed both fixed-effect and random-effects models in our analyses. We have included nine studies in this review. All were part of the original systematic review; no new trials meeting eligibility criteria were identified through our updated searches. The studies were conducted in eight different states of the USA, during the years 1967 to 1992. Nearly 1000 (946) juveniles or young adults of different races participated, almost all males. The average age of the participants in each study ranged from 15 to 17 years.Meta-analyses of seven studies show the intervention to be more harmful than doing nothing. The OR (fixed-effect) for effects on first post-treatment effect on officially measured criminal behavior indicated a negative program effect (OR 1.68, 95% confidence interval (CI) 1.20 to 2.36) and nearly identical regardless of the meta-analytic strategy (random-effectsOR 1.72, 95%CI 1.13 to 2.62).Sensitivity analyses (random-effects) showed the findings were robust even when removing one study with an inadequate randomization strategy (OR 1.47, 95% CI 1.03 to 2.11), or when removing one study with high attrition (OR 1.96, 95% CI 1.25 to 3.08), or both(OR 1.68, 95% CI 1.10 to 2.58). We conclude that programs such as 'cared Straight' increase delinquency relative to doing nothing at all to similar youths. Given these results, we cannot recommend this program as a crime prevention strategy. Agencies that permit such programs, therefore, must rigorously evaluate them, to ensure that they do not cause more harm than good to the very citizens they pledge to protect.

  18. Effect of supplementation with rebamipide for Helicobacter pylori eradication therapy: a systematic review and meta-analysis.

    PubMed

    Nishizawa, Toshihiro; Nishizawa, Yuko; Yahagi, Naohisa; Kanai, Takanori; Takahashi, Masahiko; Suzuki, Hidekazu

    2014-12-01

    Several studies have reported that the application of rebamipide during the eradication of Helicobacter pylori can improve the eradication rate. However, the efficacy and safety are controversial. The present study systematically evaluated whether rebamipide improves the eradication rate of H. pylori by conducting a meta-analysis based on randomized controlled trials (RCTs). Literature searches were conducted in the following database: PubMed, the Cochrane Library, and the Igaku-chuo-zasshi database in Japan. A meta-analysis of all RCTs comparing rebamipide supplementation with non-rebamipide-containing therapy was performed. We identified six randomized trials (611 patients). Pooled H. pylori eradication rates by per-protocol analysis were 73.3% and 61.4% for patients with or without rebamipide, respectively. The odds ratio was 1.74 (95% confidence interval. 1.19-2.53). Supplementation with rebamipide might be effective in increasing the H. pylori eradication rates of proton-pump inhibitor-amoxicillin dual therapy. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  19. Smoking and placenta previa: a meta-analysis.

    PubMed

    Shobeiri, Fatemeh; Jenabi, Ensiyeh

    2017-12-01

    Previous studies found a positive association between placenta previa and smoking during pregnancy. However, the results of these studies are inconsistent. The aim was to perform meta-analysis of the association between smoking during pregnancy and placenta previa. Major electronic databases, including PubMed, Web of Science, and Scopus were searched until June 2015. The heterogeneity across studies was explored by Q-test and I 2 statistic. The possibility of publication bias was assessed using Begg's and Egger's tests. The results were reported using odds ratio (OR) estimate with its 95% confidence intervals using a random-effects model. The literature search yielded 991 publications until October 2015 with 9,094,443 participants. Based on the random effect model, compared to nonsmoker women, the estimated OR and RR of placenta previa was 1.42 (95% CI: 1.30, 1.54) and 1.27 (95% CI: 1.18, 1.35), respectively. There is sufficient documents based on the observational studies that smoking during pregnancy is significantly associated with an increased risk of placenta previa. Therefore, smoking during pregnancy can be considered as a predictor of placenta previa.

  20. Efficacy of Psychotherapies for Borderline Personality Disorder: A Systematic Review and Meta-analysis.

    PubMed

    Cristea, Ioana A; Gentili, Claudio; Cotet, Carmen D; Palomba, Daniela; Barbui, Corrado; Cuijpers, Pim

    2017-04-01

    Borderline personality disorder (BPD) is a debilitating condition, but several psychotherapies are considered effective. To conduct an updated systematic review and meta-analysis of randomized clinical trials to assess the efficacy of psychotherapies for BPD populations. Search terms were combined for borderline personality and randomized trials in PubMed, PsycINFO, EMBASE, and the Cochrane Central Register of Controlled Trials (from database inception to November 2015), as well as the reference lists of earlier meta-analyses. Included were randomized clinical trials of adults with diagnosed BPD randomized to psychotherapy exclusively or to a control intervention. Study selection differentiated stand-alone designs (in which an independent psychotherapy was compared with control interventions) from add-on designs (in which an experimental intervention added to usual treatment was compared with usual treatment alone). Data extraction coded characteristics of trials, participants, and interventions and assessed risk of bias using 4 domains of the Cochrane Collaboration Risk of Bias tool (independent extraction by 2 assessors). Outcomes were pooled using a random-effects model. Subgroup and meta-regression analyses were conducted. Standardized mean differences (Hedges g) were calculated using all outcomes reported in the trials for borderline symptoms, self-harm, suicide, health service use, and general psychopathology at posttest and follow-up. Differential treatment retention at posttest was analyzed, reporting odds ratios. Thirty-three trials (2256 participants) were included. For borderline-relevant outcomes combined (symptoms, self-harm, and suicide) at posttest, the investigated psychotherapies were moderately more effective than control interventions in stand-alone designs (g = 0.32; 95% CI, 0.14-0.51) and add-on designs (g = 0.40; 95% CI, 0.15-0.65). Results were similar for other outcomes, including stand-alone designs: self-harm (g = 0.32; 95% CI, 0.09-0.54), suicide (g = 0.44; 95% CI, 0.15-0.74), health service use (g = 0.40; 95% CI, 0.22-0.58), and general psychopathology (g = 0.32; 95% CI, 0.09-0.55), with no differences between design types. There were no significant differences in the odds ratios for treatment retention (1.32; 95% CI, 0.87-2.00 for stand-alone designs and 1.01; 95% CI, 0.55-1.87 for add-on designs). Thirteen trials reported borderline-relevant outcomes at follow-up (g = 0.45; 95% CI, 0.15-0.75). Dialectical behavior therapy (g = 0.34; 95% CI, 0.15-0.53) and psychodynamic approaches (g = 0.41; 95% CI, 0.12-0.69) were the only types of psychotherapies more effective than control interventions. Risk of bias was a significant moderator in subgroup and meta-regression analyses (slope β = -0.16; 95% CI, -0.29 to -0.03; P = .02). Publication bias was persistent, particularly for follow-up. Psychotherapies, most notably dialectical behavior therapy and psychodynamic approaches, are effective for borderline symptoms and related problems. Nonetheless, effects are small, inflated by risk of bias and publication bias, and particularly unstable at follow-up.

  1. Meta-analysis: Association of Helicobacter pylori infection with Parkinson's diseases.

    PubMed

    Shen, Xiaoli; Yang, Huazhen; Wu, Yili; Zhang, Dongfeng; Jiang, Hong

    2017-10-01

    The results from observational studies on the relationship between helicobacter pylori (H. pylori) infection and Parkinson's disease remain controversial. A meta-analysis was conducted to evaluate the association between helicobacter pylori infection and Parkinson's disease. A comprehensive literature search was performed on relevant studies published from January 1983 to January 2017 in PubMed, Web of Science and EMBASE databases. The fixed or random effects model was used to pool the odds ratio with 95% confidence interval from individual studies. Publication bias was estimated by Egger's test and the funnel plot. Eight eligible studies involving 33 125 participants were included in this meta-analysis. Compared with the no helicobacter pylori infected person, the pooled odds ratio of Parkinson's disease in helicobacter pylori infected person was 1.59 (95% confidence interval: 1.37-1.85). In subgroup analyzes, the combined odds ratios were 1.96 (1.23-3.12) in Asia, 1.55 (1.32-1.82) in Europe, 1.59 (1.35-1.88) in case-control studies, 1.56 (1.01-2.39) in cross-sectional studies, 1.56 (1.32-1.85) in studies with confounders adjusted, and 1.71 (1.21-2.43) in studies with no confounder adjusted, respectively. This meta-analysis indicated that H. pylori infection might be associated with the risk of Parkinson's disease. © 2017 John Wiley & Sons Ltd.

  2. Maternal Consumption of Coffee and Caffeine-containing Beverages and Oral Clefts: A Population-based Case-Control Study in Norway

    PubMed Central

    Wilcox, Allen J.; Lie, Rolv T.; Andersen, Lene F.; Drevon, Christian A.

    2009-01-01

    A large, population-based case-control study of facial clefts was carried out in Norway between 1996 and 2001. The study included 573 cases—377 with cleft lip with or without cleft palate and 196 with cleft palate only—and 763 randomly selected controls. Maternal consumption of coffee and other caffeine-containing beverages in early pregnancy was recorded shortly after birth. Compared with that for no coffee consumption, the adjusted odds ratios for cleft lip with or without cleft palate were 1.39 (95% confidence interval: 1.01, 1.92) for less than 3 cups a day and 1.59 (95% confidence interval: 1.05, 2.39) for 3 cups or more. Coffee consumption was not associated with risk of cleft palate only (for ≥3 cups vs. none, adjusted odds ratio = 0.96, 95% confidence interval: 0.55, 1.67). Tea consumption was associated with a reduced odds ratio of both cleft lip with or without cleft palate and cleft palate only. There was little evidence of an association between caffeine exposure and clefts when all sources of caffeine were considered. Adjustment for known confounding factors in general had minor effects on risk estimates. Still, the authors could not rule out the possibility of uncontrolled confounding by factors associated with the habit of drinking coffee. PMID:19342400

  3. The Link Between Everyday Discrimination, Healthcare Utilization, and Health Status Among a National Sample of Women.

    PubMed

    Fazeli Dehkordy, Soudabeh; Hall, Kelli S; Dalton, Vanessa K; Carlos, Ruth C

    2016-10-01

    Research has not adequately examined the potential negative effects of perceiving routine discrimination on general healthcare utilization or health status, especially among reproductive-aged women. We sought to evaluate the association between everyday discrimination, health service use, and perceived health among a national sample of women in the United States. Data were drawn from the Women's Healthcare Experiences and Preferences survey, a randomly selected, national probability sample of 1078 U.S. women aged 18-55 years. We examined associations between everyday discrimination (via a standardized scale) on frequency of health service utilization and perceived general health status using chi-square and multivariable logistic regression modeling. Compared with women who reported healthcare visits every 3 years or less (reference group), each one-point increase in discrimination score was associated with higher odds of having healthcare visits annually or more often (odds ratio [OR] = 1.36, confidence interval [95% CI] = 1.01-1.83). Additionally, each one-point increase in discrimination score was significantly associated with lower odds of having excellent/very good perceived health (OR = 0.65; 95% CI = 0.54-0.80). Perceived discrimination was associated with increased exposure to the healthcare setting among this national sample of women. Perceived discrimination was also inversely associated with excellent/very good perceived health status.

  4. Tuberculosis and diabetes mellitus in the Republic of Kiribati: a case-control study.

    PubMed

    Viney, K; Cavanaugh, J; Kienene, T; Harley, D; Kelly, P M; Sleigh, A; O'Connor, J; Mase, S

    2015-05-01

    To better inform local management of TB-diabetes collaborative activities, we aimed to determine the prevalence of diabetes among persons with and without TB and to determine the association between TB and diabetes in Kiribati, a Pacific Island nation. We compared consecutively enrolled TB cases to a group of randomly selected community controls without evidence of TB. Diabetes was diagnosed by HbA1c, and clinical and demographic data were collected. A tuberculin skin test was administered to controls. The chi-square test was used to assess significance in differences between cases and controls. We also calculated an odds ratio, with 95% confidence intervals, for the odds of diabetes among cases relative to controls. Unweighted multivariate logistic regression was performed to adjust for the effects of age and sex. A total of 275 TB cases and 499 controls were enrolled. The diabetes prevalence in cases (101, 37%) was significantly greater than in controls (94, 19%) (adjusted odds ratio: 2.8; 95% CI 2.0-4.1). Fifty-five percent (108) of all diabetic diagnoses were new; this proportion was higher among controls (64.8%) than cases (46.5%). Five patients with TB were screened to detect one patient with diabetes. There is a strong association between TB and diabetes in Kiribati and bidirectional screening should be conducted in this setting. © 2015 John Wiley & Sons Ltd.

  5. Cellular phones, cordless phones, and the risks of glioma and meningioma (Interphone Study Group, Germany).

    PubMed

    Schüz, Joachim; Böhler, Eva; Berg, Gabriele; Schlehofer, Brigitte; Hettinger, Iris; Schlaefer, Klaus; Wahrendorf, Jürgen; Kunna-Grass, Katharina; Blettner, Maria

    2006-03-15

    The widespread use of cellular telephones has generated concern about possible adverse health effects, particularly brain tumors. In this population-based case-control study carried out in three regions of Germany, all incident cases of glioma and meningioma among patients aged 30-69 years were ascertained during 2000-2003. Controls matched on age, gender, and region were randomly drawn from population registries. In total, 366 glioma cases, 381 meningioma cases, and 1,494 controls were interviewed. Overall use of a cellular phone was not associated with brain tumor risk; the respective odds ratios were 0.98 (95% confidence interval (CI): 0.74, 1.29) for glioma and 0.84 (95% CI: 0.62, 1.13) for meningioma. Among persons who had used cellular phones for 10 or more years, increased risk was found for glioma (odds ratio = 2.20, 95% CI: 0.94, 5.11) but not for meningioma (odds ratio = 1.09, 95% CI: 0.35, 3.37). No excess of temporal glioma (p = 0.41) or meningioma (p = 0.43) was observed in cellular phone users as compared with nonusers. Cordless phone use was not related to either glioma risk or meningioma risk. In conclusion, no overall increased risk of glioma or meningioma was observed among these cellular phone users; however, for long-term cellular phone users, results need to be confirmed before firm conclusions can be drawn.

  6. The Influence of Oral Dydrogesterone and Vaginal Progesterone on Threatened Abortion: A Systematic Review and Meta-Analysis

    PubMed Central

    Lee, Hee Joong; Park, Tae Chul; Kim, Jae Hoon; Norwitz, Errol

    2017-01-01

    Objective To conduct systematic analyses to evaluate the efficacy of progesterone therapy for the prevention of miscarriages in pregnant women experiencing threatened abortion. Methods In November 2016, we performed a systematic literature search and identified 51 articles in PubMed, Embase, and Cochrane databases. We identified nine randomized trials that included 913 pregnant women (including 322 treated with oral dydrogesterone, 213 treated with vaginal progesterone, and 378 control subjects) who met the selection criteria. Results The incidence of miscarriage was significantly lower in the total progesterone group than in the control group (13.0% versus 21.7%; odds ratio, 0.53; 95% confidence interval (CI), 0.36 to 0.78; P = 0.001; I2, 0%). Moreover, the incidence of miscarriage was significantly lower in the oral dydrogesterone group than in the control group (11.7% versus 22.6%; odds ratio, 0.43; 95% CI, 0.26 to 0.71; P = 0.001; I2, 0%) and was lower in the vaginal progesterone group than in the control group, although this difference was nonsignificant (15.4% versus 20.3%; odds ratio, 0.72; 95% CI, 0.39 to 1.34; P = 0.30; I2, 0%). However, the incidence of miscarriage was not different between the oral dydrogesterone and vaginal progesterone groups. Conclusion Progesterone therapy, especially oral dydrogesterone, can effectively prevent miscarriage in pregnant women experiencing threatened abortion. PMID:29392134

  7. Effect of prenatal smoking cessation interventions on birth weight: meta-analysis.

    PubMed

    Veisani, Yousef; Jenabi, Ensiyeh; Delpisheh, Ali; Khazaei, Salman

    2017-09-19

    Smoking is preventable factor for pregnancy outcomes such as low birth weight (LBW). In this study, we assessed the effects of smoking cessation in pregnancy period on the birth weight in Randomized Controlled Trial studies (RCTs). International databases of Pub Med, Scopus, and Web of Science, by the MeSH heading and/or additional terms, were searched to assess relevant studies in systematic possess. I 2 statistics was used to assess of heterogeneity. Pooled effects size was obtained by random effects model. Meta-regression was used to explore of heterogeneity using Stata software version 12 (Stata Corp, College Station, TX). A total 16 RCTs, 6192 women were enrolled to assess of smoking cessation in pregnancy period on the birth weight. Relative risk (RR) of not smoking at the end of pregnancy in intervention group was 2.47 (95% CI: 1.73-3.20). The odds ratio (OR) for effect of smoking cessation on LBW was 0.65 (95% CI: 0.42-0.88) and standardized mean difference (SMD) was significantly increased in the intervention group, 0.28 (95% CI: 0.05-0.50). Results of this study approve results of previous RCTs that smoking cessation in pregnancy is a good practical action to prevention of LBW in infants.

  8. Combining Parent and Child Training for Young Children with ADHD

    PubMed Central

    Webster-Stratton, Carolyn

    2011-01-01

    The efficacy of the Incredible Years parent and child training programs is established in children diagnosed with oppositional defiant disorder (ODD) but not among young children whose primary diagnosis is attention-deficit/hyperactivity disorder (ADHD). We conducted a randomized control trial evaluating the combined parent and child program interventions among 99 children diagnosed with ADHD (ages 4–6). Mother reported significant treatment effects for appropriate and harsh discipline, use of physical punishment, and monitoring, whereas fathers reported no significant parenting changes. Independent observations revealed treatment effects for mothers' praise and coaching, mothers' critical statements, and child total deviant behaviors. Both mothers and fathers reported treatment effects for children's externalizing, hyperactivity, inattentive and oppositional behaviors, and emotion regulation and social competence. There were also significant treatment effects for children's emotion vocabulary and problem-solving ability. At school teachers reported treatment effects for externalizing behaviors and peer observations indicated improvements in treated children's social competence. PMID:21391017

  9. A prevention programme for somatoform disorders is effective for affective disorders.

    PubMed

    García-Campayo, Javier; Arevalo, Elisa; Claraco, Luis Manuel; Alda, Marta; Lopez del Hoyo, Yolanda

    2010-04-01

    To assess the effectiveness of a psycho-educational programme for the primary prevention of somatoform disorders in healthy primary care patients. Randomized, controlled trial. Participants (N=104) were randomly assigned to: (1) a psycho-educational intervention, or (2) no intervention at all. The primary outcome measure was somatoform disorder psychiatric diagnosis at 5-year follow-up. Secondary outcome measures were hypochondriasis, locus of control and attribution of symptoms and psychological distress. At 3 and 6 months, and 5 years, the intervention group significantly decreased hypochondriasis and somatic attributions; and increased psychological and normalizing attributions and internal locus of control. Five years after baseline, the prevalence of somatoform disorders showed no differences between both groups. Nevertheless, overall psychiatric morbidity was less prevalent in the intervention group (odds ratio: 2.72; 95%CI:1.10-6.72). In addition, a decrease in depression and anxiety subscales and in overall General Health Questionnaire scoring (p<.05) was found in the intervention group. A primary prevention programme for somatization seems to be useful, not to decrease somatoform disorders, but to prevent anxiety and depressive disorders. The effects of overlapping psychobiological mechanisms are discussed. Copyright 2009 Elsevier B.V. All rights reserved.

  10. Experiences of Domestic Violence and Mental Disorders: A Systematic Review and Meta-Analysis

    PubMed Central

    Trevillion, Kylee; Oram, Siân; Feder, Gene; Howard, Louise M.

    2012-01-01

    Background Little is known about the extent to which being a victim of domestic violence is associated with different mental disorders in men and women. We aimed to estimate the prevalence and odds of being a victim of domestic violence by diagnostic category and sex. Methods Study design: Systematic review and meta-analysis. Data Sources: Eighteen biomedical and social sciences databases (including MEDLINE, EMBASE, PsycINFO); journal hand searches; scrutiny of references and citation tracking of included articles; expert recommendations, and an update of a systematic review on victimisation and mental disorder. Inclusion criteria: observational and intervention studies reporting prevalence or odds of being a victim of domestic violence in men and women (aged ≥16 years), using validated diagnostic measures of mental disorder. Procedure: Data were extracted and study quality independently appraised by two reviewers. Analysis: Random effects meta-analyses were used to pool estimates of prevalence and odds. Results Forty-one studies were included. There is a higher risk of experiencing adult lifetime partner violence among women with depressive disorders (OR 2.77 (95% CI 1.96–3.92), anxiety disorders (OR 4.08 (95% CI 2.39–6.97), and PTSD (OR 7.34 95% CI 4.50–11.98), compared to women without mental disorders. Insufficient data were available to calculate pooled odds for other mental disorders, family violence (i.e. violence perpetrated by a non-partner), or violence experienced by men. Individual studies reported increased odds for women and men for all diagnostic categories, including psychoses, with a higher prevalence reported for women. Few longitudinal studies were found so the direction of causality could not be investigated. Conclusions There is a high prevalence and increased likelihood of being a victim of domestic violence in men and women across all diagnostic categories, compared to people without disorders. Longitudinal studies are needed to identify pathways to being a victim of domestic violence to optimise healthcare responses. PMID:23300562

  11. Can Geographical Factors Determine the Choices of Farmers in the Ethiopian Highlands to Trade in Livestock Markets?

    PubMed Central

    Ortiz-Pelaez, Angel; Ashenafi, Getaneh; Roger, Francois; Waret-Szkuta, Agnes

    2012-01-01

    Proximity and affiliation to the local market appear to be two of the most relevant factors to explain farmer's choices to select a particular trading point. Physical barriers may limit the options , especially in developing countries. A network of villages linked by traders/farmer-traders sharing livestock markets was built with field data collected in 75 villages from 8 kebelles in the Wassona Werna wereda of the Ethiopian Highlands. Two exponential random graph models were fitted with various geographical and demographic attributes of the nodes (dyadic independent model) and three internal network structures (dyadic dependent model). Several diagnostic methods were applied to assess the goodness of fit of the models. The odds of an edge where the distance to the main market Debre Behran and the difference in altitude between two connected villages are both large increases significantly so that villages far away from the main market and at different altitude are more likely to be linked in the network than randomly. The odds of forming an edge between two villages in Abamote or Gudoberet kebelles are approximately 75% lower than an edge between villages in any other kebelles (p<0.05). The conditional log-odds of two villages forming a tie that is not included in a triangle, a 2-star or a 3-star is extremely low, increasing the odds significantly (p<0.05) each time a node is in a 2-star structure and decreasing it when a node is in a 3-star (p<0.05) or in a triangle formation (p<0.05)), conditional on the rest of the network. Two major constraining factors, namely distance and altitude, are not deterrent for the potential contact of susceptible small ruminant populations in the Highlands of Ethiopia. PMID:22355324

  12. Social inequalities in oral health and in use of oral health care services among adolescents in Uganda.

    PubMed

    Okullo, I; Astrøm, A N; Haugejorden, O

    2004-09-01

    The aim of this study was to describe clinical and self-perceived indicators of oral health status and the use of oral health care services by social and demographic characteristics. In 2001, a cross-sectional random sample survey was conducted in urban and rural settings in Uganda (Kampala and Lira, respectively), and 1146 secondary school students with a mean age of 15.8 years completed questionnaires in school. Dental caries was recorded by one examiner on a random subsample of 372 students. Logistic regression analyses revealed that being an urban resident was associated with higher odds for having dental caries (dmft > 0), seeking care because of toothache (delayed treatment demand) and being dissatisfied with one's own oral health status [adjusted odds ratio (OR) = 1.5-2.1]. Being an urban resident was associated with lower odds for oral health care attendance generally and for having missing teeth in particular (adjusted OR = 0.6-0.4). Students who had parents with a higher education and those with weak social ties were, respectively, less and more likely to be dissatisfied with their oral health status. As compared to caries-free participants, the odds for being dissatisfied with oral health and delayed treatment demand increased significantly with an increasing dmft score (adjusted OR = 2.1-3.2). Urban students were most likely to have a dmft > 0 and to rate their oral health status negatively. Having received dental care and the prevalence of missing teeth, and delayed treatment demand were, respectively, most and least prevalent among rural students. Dental caries at different diagnostic cut-off points and weak social ties affected self-reported oral health negatively, independently of social and demographic characteristics. Copyright 2004 BSPD and IAPD

  13. A primary-school-based study to reduce the prevalence of childhood obesity – the EdAl (Educació en Alimentació) study: a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Obesity is one of the main determinants of avoidable disease burden. To implement a program by university students acting as “health promoting agents” (HPAs) and to evaluate the effects on obesity prevalence of the primary-school-based program that promotes healthy lifestyle, including dietary and physical activity recommendations over 28 months. Methods Two school clusters were randomly assigned to intervention (24 schools, 1,222 pupils) or control (14 schools, 717 pupils); 78% of pupils were Western European. Mean age (±SD) was 8.4 ± 0.6 years (49.9% females) at baseline. Generalized linear mixed models were used to analyze differences in primary outcome between both groups. Data collected included body mass index (BMI) every year. Dietary habits and lifestyle questionnaires were filled in by the parents at baseline and at the end of the study. The interventions focused on eight lifestyle topics covered in 12 activities (1 hour/activity/session) implemented by HPAs over 3 school academic years. Results At 28 months, obesity prevalence in boys was decreased −2.36% in the intervention group (from 9.59% to 7.23%) and increased 2.03% (from 7.40% to 9.43%) in the control group; the difference was 4.39% (95% CI 3.48 to 5.30; P = 0.01). The boys in the intervention group had an effective reduction of −0.24 units in the change of BMI z-score (from 0.01 to −0.04), compared to control (from −0.10 to 0.09); 5.1% more intervention pupils undertook physical activity >5 hours/week than control pupils (P = 0.02). Fish consumption was a protector (odds ratio 0.39; 95% CI 0.23 to 0.67) while “fast-food” consumption was a risk factor for childhood obesity (odds ratio: 2.27; 95% CI 1.08 to 4.77). Conclusions Our school-based program, conducted by HPA students, successfully reduced childhood obesity prevalence in boys. Trial registration International Standard Randomized Controlled Trial Number: ISRCTN29247645. PMID:24529258

  14. Identifying Older Adults at Risk of Delirium Following Elective Surgery: A Systematic Review and Meta-Analysis.

    PubMed

    Watt, Jennifer; Tricco, Andrea C; Talbot-Hamon, Catherine; Pham, Ba'; Rios, Patricia; Grudniewicz, Agnes; Wong, Camilla; Sinclair, Douglas; Straus, Sharon E

    2018-04-01

    Postoperative delirium is a common preventable complication experienced by older adults undergoing elective surgery. In this systematic review and meta-analysis, we identified prognostic factors associated with the risk of postoperative delirium among older adults undergoing elective surgery. Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and AgeLine were searched for articles published between inception and April 21, 2016. A total of 5692 titles and abstracts were screened in duplicate for possible inclusion. Studies using any method for diagnosing delirium were eligible. Two reviewers independently completed all data extraction and quality assessments using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale (NOS) for cohort studies. Random effects meta-analysis models were used to derive pooled effect estimates. Forty-one studies (9384 patients) reported delirium-related prognostic factors. Among our included studies, the pooled incidence of postoperative delirium was 18.4% (95% confidence interval [CI] 14.3-23.3%, number needed to follow [NNF] = 6). Geriatric syndromes were important predictors of delirium, namely history of delirium (odds ratio [OR] 6.4, 95% CI 2.2-17.9), frailty (OR 4.1, 95% CI 1.4-11.7), cognitive impairment (OR 2.7, 95% CI 1.9-3.8), impairment in activities of daily living (ADLs; OR 2.1, 95% CI 1.6-2.6), and impairment in instrumental activities of daily living (IADLs; OR 1.9, 95% CI 1.3-2.8). Potentially modifiable prognostic factors such as psychotropic medication use (OR 2.3, 95% CI 1.4-3.6) and smoking status (OR 1.8 95% CI 1.3-2.4) were also identified. Caregiver support was associated with lower odds of postoperative delirium (OR 0.69, 95% CI 0.52-0.91). Though caution must be used in interpreting meta-analyses of non-randomized studies due to the potential influence of unmeasured confounding, we identified potentially modifiable prognostic factors including frailty and psychotropic medication use that should be targeted to optimize care.

  15. Patient education for colon cancer screening: a randomized trial of a video mailed before a physical examination.

    PubMed

    Zapka, Jane G; Lemon, Stephenie C; Puleo, Elaine; Estabrook, Barbara; Luckmann, Roger; Erban, Stephen

    2004-11-02

    Colorectal cancer screening is underused, and primary care clinicians are challenged to provide patient education within the constraints of busy practices. To test the effect of an educational video, mailed to patients' homes before a physical examination, on performance of colorectal cancer screening, particularly sigmoidoscopy. Randomized, controlled trial. 5 primary care practices in central Massachusetts. 938 patients age 50 to 74 years who were scheduled for an upcoming physical examination, had no personal history of colorectal cancer, and were eligible for lower-endoscopy screening according to current guidelines. Participants were randomly assigned to receive usual care (n = 488) or a video about colorectal cancer, the importance of early detection, and screening options (n = 450). Baseline and 6-month follow-up telephone assessments were conducted. A dependent variable classified screening since baseline as 1) sigmoidoscopy with or without other tests, 2) another test or test combination, or 3) no tests. Overall screening rates were the same in the intervention and control groups (55%). In regression modeling, intervention participants were nonsignificantly more likely to complete sigmoidoscopy alone or in combination with another test (odds ratio, 1.22 [95% CI, 0.88 to 1.70]). Intervention dose (viewing at least half of the video) was significantly related to receiving sigmoidoscopy with or without another test (odds ratio, 2.81 [CI, 1.85 to 4.26]). Recruitment records showed that at least 23% of people coming for periodic health assessments were currently screened by a lower-endoscopy procedure and therefore were not eligible. The primary care sample studied consisted primarily of middle-class white persons who had high screening rates at baseline. The results may not be generalizable to other populations. The trial was conducted during a period of increased health insurance coverage for lower-endoscopy procedures and public media attention to colon cancer screening. A mailed video had no effect on the overall rate of colorectal cancer screening and only modestly improved sigmoidoscopy screening rates among patients in primary care practices.

  16. A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

    PubMed

    Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

    2016-01-01

    Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  17. Health impact and cost-effectiveness of a private sector bed net distribution: experimental evidence from Zambia

    PubMed Central

    2013-01-01

    Background Relatively few programmes have attempted to actively engage the private sector in national malaria control efforts. This paper evaluates the health impact of a large-scale distribution of insecticide-treated nets (ITNs) conducted in partnership with a Zambian agribusiness, and its cost-effectiveness from the perspective of the National Malaria Control Programme (NMCP). Methods The study was designed as a cluster-randomized controlled trial. A list of 81,597 cotton farmers was obtained from Dunavant, a contract farming company in Zambia’s cotton sector, in December 2010. 39,963 (49%) were randomly selected to obtain one ITN each. Follow-up interviews were conducted with 438 farmers in the treatment and 458 farmers in the control group in June and July 2011. Treatment and control households were compared with respect to bed net ownership, bed net usage, self-reported fever, and self-reported confirmed malaria. Cost data was collected throughout the programme. Results The distribution effectively reached target beneficiaries, with approximately 95% of households in the treatment group reporting that they had received an ITN through the programme. The average increase in the fraction of household members sleeping under an ITN the night prior to the interview was 14.6 percentage points (p-value <0.001). Treatment was associated with a 42 percent reduction in the odds of self-reported fever (p-value <0.001) and with a 49 percent reduction in the odds of self-reported malaria (p-value 0.002). This was accomplished at a cost of approximately five US$ per ITN to Zambia’s NMCP. Conclusions The results illustrate that existing private sector networks can efficiently control malaria in remote rural regions. The intra-household allocation of ITNs distributed through this channel was comparable to that of ITNs received from other sources, and the health impact remained substantial. PMID:23506170

  18. Predictors of local adverse effects caused by topical tretinoin cream 0·1% in the Veterans Affairs Topical Tretinoin Chemoprevention trial.

    PubMed

    Pomerantz, H; Weinstock, M A

    2014-09-01

    Topical tretinoin is commonly prescribed, but its frequent adverse effects are barriers to use. Predictors of resistance or susceptibility to retinoid irritation are not known. To identify baseline patient characteristics associated with adverse effects of topical tretinoin. This cohort study used data collected from 324 participants in the Veterans Affairs Topical Tretinoin Chemoprevention trial who were randomized to apply tretinoin cream on the face and ears. Univariate and multivariate logistic regression models were used to examine the associations between baseline characteristics and local adverse effects. One hundred and ninety-seven patients (61% of those randomized to tretinoin) reported local adverse effects within 6 months. Clinical signs of severe photodamage at baseline [odds ratio (OR) 0·15, 95% confidence interval (CI) 0·04-0·54] and history of acne (OR 0·46, 95% CI 0·27-0·77) were associated with a decreased risk of adverse effects to tretinoin. The use of other topical medications at enrolment (OR 1·88, 95% CI 1·15-3·08) predicted an increase in adverse effects. In this study population, the common indications of topical tretinoin treatment were associated with lower risks of adverse effects. The concurrent use of other topical medications may worsen irritation caused by tretinoin. © 2014 British Association of Dermatologists.

  19. Nanoparticle albumin-bound paclitaxel as neoadjuvant chemotherapy of breast cancer: a systematic review and meta-analysis.

    PubMed

    Zong, Yu; Wu, Jiayi; Shen, Kunwei

    2017-03-07

    The value of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in neoadjuvant systemic therapy for breast cancer remains uncertain. Both electronic databases and proceedings of oncologic meetings were included in systematic literature search. Pooled rates of pathological complete response (pCR), odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using fixed-effect or random-effect model to determine the effect of neoadjuvant nab-paclitaxel. Twenty-one studies with 2357 patients were included, 3 of which were randomized clinical trials. The aggregate pCR(ypT0/is ypN0) rate was 32% (95% CI 25-38%) in unselected breast cancer patients and variated in different subtypes. Within randomized clinical trials, the probability of achieving pCR was significantly higher in the nab-paclitaxel group than in the conventional taxanes group (OR = 1.383, 95%CI 1.141-1.676, p = 0.001). For non-hematological toxic effect, any grade and grade 3-4 peripheral sensory neuropathy occurred more frequently with nab-paclitaxel compared to paclitaxel (any grade, OR = 2.090, 95%CI 1.016-4.302, p = 0.045; grade3-4, OR = 3.766, 95%CI 2.324-6.100, p < 0.001). Hypersensitivity was more common with paclitaxel than nab-paclitaxel at any grade and grade 3-4. nab-paclitaxel is an effective cytotoxic drug in neoadjuvant treatment of breast cancer, especially for aggressive tumors in terms of pCR. Exchange of nab-paclitaxel for conventional taxanes could significantly improve pCR rate with reasonable toxicities.

  20. Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

    PubMed

    Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

    2015-02-01

    Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

  1. The effects of multi-disciplinary psycho-social care on socio-economic problems in cancer patients: a cluster-randomized trial.

    PubMed

    Singer, Susanne; Roick, Julia; Meixensberger, Jürgen; Schiefke, Franziska; Briest, Susanne; Dietz, Andreas; Papsdorf, Kirsten; Mössner, Joachim; Berg, Thomas; Stolzenburg, Jens-Uwe; Niederwieser, Dietger; Keller, Annette; Kersting, Anette; Danker, Helge

    2018-06-01

    We examined whether multi-disciplinary stepped psycho-social care decreases financial problems and improves return-to-work in cancer patients. In a university hospital, wards were randomly allocated to either stepped or standard care. Stepped care comprised screening for financial problems, consultation between doctor and patient, and the provision of social service. Outcomes were financial problems at the time of discharge and return-to-work in patients < 65 years old half a year after baseline. The analysis employed mixed-effect multivariate regression modeling. Thirteen wards were randomized and 1012 patients participated (n = 570 in stepped care and n = 442 in standard care). Those who reported financial problems at baseline were less likely to have financial problems at discharge when they had received stepped care (odds ratio (OR) 0.2, 95% confidence interval (CI) 0.1, 0.7; p = 0.01). There was no evidence for an effect of stepped care on financial problems in patients without such problems at baseline (OR 1.1, CI 0.5, 2.6; p = 0.82). There were 399 patients < 65 years old who were not retired at baseline. In this group, there was no evidence for an effect of stepped care on being employed half a year after baseline (OR 0.7, CI 0.3, 2.0; p = 0.52). NCT01859429 CONCLUSIONS: Financial problems can be avoided more effectively with multi-disciplinary stepped psycho-social care than with standard care in patients who have such problems.

  2. Efficacy of a Process Improvement Intervention on Delivery of HIV Services to Offenders: A Multisite Trial

    PubMed Central

    Shafer, Michael S.; Dembo, Richard; del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L.; Belenko, Steven; Frisman, Linda K.; Visher, Christy A.; Pich, Michele; Patterson, Yvonne

    2014-01-01

    Objectives. We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. Methods. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. Results. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Conclusions. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments. PMID:25322311

  3. Social capital and neo-materialist contextual determinants of sense of insecurity in the neighbourhood: a multilevel analysis in Southern Sweden.

    PubMed

    Lindström, Martin; Lindström, Christine; Moghaddassi, Mahnaz; Merlo, Juan

    2006-12-01

    The aim of this study was to investigate the influence of contextual (social capital and neo-materialist) and individual factors on sense of insecurity in the neighbourhood. The 2000 public health survey in Scania is a cross-sectional study. A total of 13,715 persons answered a postal questionnaire, which is 59% of the random sample. A multilevel logistic regression model, with individuals at the first level and municipalities at the second, was performed. The effect (median odds ratios, intra-class correlation, cross-level modification and odds ratios) of individual and municipality/city quarter (social capital and police district) factors on sense of insecurity was analysed. The crude variance between municipalities/city quarters was not affected by individual factors. The introduction of administrative police district in the model reduced the municipality variance, although some of the significant variance between municipalities remained. The introduction of social capital did not affect the municipality variance. This study suggests that the neo-materialist factor administrative police district may partly explain the individual's sense of insecurity in the neighbourhood.

  4. Self-reported bruxism mirrors anxiety and stress in adults.

    PubMed

    Ahlberg, Jari; Lobbezoo, Frank; Ahlberg, Kristiina; Manfredini, Daniele; Hublin, Christer; Sinisalo, Juha; Könönen, Mauno; Savolainen, Aslak

    2013-01-01

    The aims were to analyze whether the levels of self-reported bruxism and anxiety associate among otherwise healthy subjects, and to investigate the independent effects of anxiety and stress experience on the probability of self-reported bruxism. As part of a study on irregular shift work, a questionnaire was mailed to all employees of the Finnish Broadcasting Company with irregular shift work (number of subjects: n=750) and to an equal number of randomly selected employees in the same company with regular eight-hour daytime work. The response rates were 82.3% (56.6 % men) and 34.3 % (46.7 % men), respectively. Among the 874 respondents, those aware of more frequent bruxism reported significantly more severe anxiety (p<0.001). Adjusted by age and gender, frequent bruxers were more than two times more likely to report severe stress (odds ratio 2.5; 95% confidence interval 1.5-4.2) and anxiety (odds ratio 2.2; 95% confidence interval 1.3-3.6) than non-or-mild bruxers. Present findings suggest that self-reported bruxism and psychological states such as anxiety or stress may be related in working age subjects.

  5. Diagnostic accuracy of HLA-B*57:01 screening for the prediction of abacavir hypersensitivity and clinical utility of the test: a meta-analytic review.

    PubMed

    Cargnin, Sarah; Jommi, Claudio; Canonico, Pier Luigi; Genazzani, Armando A; Terrazzino, Salvatore

    2014-05-01

    To determine diagnostic accuracy of HLA-B*57:01 testing for prediction of abacavir-induced hypersensitivity and to quantify the clinical benefit of pretreatment screening through a meta-analytic review of published studies. A comprehensive search was performed up to June 2013. The methodological quality of relevant studies was assessed by the QUADAS-2 tool. The pooled diagnostic estimates were calculated using a random effect model. Despite the presence of heterogeneity in sensitivity or specificity estimates, the pooled diagnostic odds ratio to detect abacavir-induced hypersensitivity on the basis of clinical criteria was 33.07 (95% CI: 22.33-48.97, I(2): 13.9%), while diagnostic odds ratio for detection of immunologically confirmed abacavir hypersensitivity was 1141 (95% CI: 409-3181, I(2): 0%). Pooled analysis of risk ratio showed that prospective HLA-B*57:01 testing significantly reduced the incidence of abacavir-induced hypersensitivity. This meta-analysis demonstrates an excellent diagnostic accuracy of HLA-B*57:01 testing to detect immunologically confirmed abacavir hypersensitivity and corroborates existing recommendations.

  6. Efficacy of a process improvement intervention on delivery of HIV services to offenders: a multisite trial.

    PubMed

    Pearson, Frank S; Shafer, Michael S; Dembo, Richard; Del Mar Vega-Debién, Graciela; Pankow, Jennifer; Duvall, Jamieson L; Belenko, Steven; Frisman, Linda K; Visher, Christy A; Pich, Michele; Patterson, Yvonne

    2014-12-01

    We tested a modified Network for the Improvement of Addiction Treatment (NIATx) process improvement model to implement improved HIV services (prevention, testing, and linkage to treatment) for offenders under correctional supervision. As part of the Criminal Justice Drug Abuse Treatment Studies, Phase 2, the HIV Services and Treatment Implementation in Corrections study conducted 14 cluster-randomized trials in 2011 to 2013 at 9 US sites, where one correctional facility received training in HIV services and coaching in a modified NIATx model and the other received only HIV training. The outcome measure was the odds of successful delivery of an HIV service. The results were significant at the .05 level, and the point estimate for the odds ratio was 2.14. Although overall the results were heterogeneous, the experiments that focused on implementing HIV prevention interventions had a 95% confidence interval that exceeded the no-difference point. Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of HIV services in correctional environments.

  7. Calcium/vitamin D supplementation and coronary artery calcification in the Women's Health Initiative.

    PubMed

    Manson, JoAnn E; Allison, Matthew A; Carr, J Jeffrey; Langer, Robert D; Cochrane, Barbara B; Hendrix, Susan L; Hsia, Judith; Hunt, Julie R; Lewis, Cora E; Margolis, Karen L; Robinson, Jennifer G; Rodabough, Rebecca J; Thomas, Asha M

    2010-07-01

    Coronary artery calcified plaque is a marker for atheromatous plaque burden and predicts future risk of cardiovascular events. The relationship between calcium plus vitamin D (calcium/D) supplementation and coronary artery calcium (CAC) has not been previously assessed in a randomized trial setting. We compared CAC scores after trial completion between women randomized to calcium/vitamin D supplementation and women randomized to placebo. In an ancillary substudy of women randomized to calcium carbonate (1,000 mg of elemental calcium daily) plus vitamin D3 (400 IU daily) or placebo, nested within the Women's Health Initiative trial of estrogen among women who underwent hysterectomy, we measured CAC with cardiac CT in 754 women aged 50 to 59 years at randomization. Imaging for CAC was performed at 28 of 40 centers after a mean of 7 years of treatment, and scans were read centrally. CAC scores were measured by a central reading center with masking to randomization assignments. Posttrial CAC measurements were similar in women randomized to calcium/D supplementation and those receiving placebo. The mean CAC score was 91.6 for women receiving calcium/D and 100.5 for women receiving placebo (rank test P value = 0.74). After adjustment for coronary risk factors, multivariate odds ratios for increasing CAC score cutpoints (CAC >0, > or =10, and > or =100) for calcium/D versus placebo were 0.92 (95% CI, 0.64-1.34), 1.29 (0.88-1.87), and 0.90 (0.56-1.44), respectively. Corresponding odds ratios among women with a 50% or higher adherence to study pills and for higher levels of CAC (>300) were similar. Treatment with moderate doses of calcium plus vitamin D3 did not seem to alter coronary artery calcified plaque burden among postmenopausal women. Whether higher or lower doses would affect this outcome remains uncertain.

  8. ADHD and Depression Symptoms in Parent Couples Predict Response to Child ADHD and ODD Behavior.

    PubMed

    Wymbs, Brian T; Dawson, Anne E; Egan, Theresa E; Sacchetti, Gina M; Tams, Sean T; Wymbs, Frances A

    2017-04-01

    Parents of children with attention-deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) often have elevated ADHD and depressive symptoms, both of which increase the risk of ineffective parenting and interparental discord. However, little is known about whether child ADHD/ODD behavior and parent ADHD or depressive symptoms uniquely or synergistically predict the quality of parenting and interparental communication during triadic (mother-father-child) interactions. Ninety parent couples, including 51 who have children diagnosed with ADHD, were randomly assigned to interact with a 9-12 year-old confederate child (84 % male) exhibiting either ADHD/ODD-like behavior or typical behavior. Parents reported their own ADHD and depressive symptoms, and parents and observers rated the quality of parenting and interparental communication during the interaction. Actor-partner interdependence modeling indicated that child ADHD/ODD behavior predicted less positive and more negative parenting and communication, independent of adult ADHD and depressive symptoms. Parent couples including two parents with elevated ADHD communicated more positively while managing children exhibiting ADHD/ODD behavior than couples managing children behaving typically or couples with only one parent with elevated ADHD symptoms. Couples including one parent with, and one parent without, elevated ADHD or depressive symptoms parented less positively and more negatively, and communicated more negatively, when managing children exhibiting ADHD/ODD behavior than when managing children behaving typically. Taken together, depending on the similarity of ADHD and depressive symptom levels in parent couples, adults managing children exhibiting ADHD/ODD behavior may parent or communicate positively or negatively. Findings highlight the need to consider the psychopathology of both parents when treating children with ADHD in two-parent homes.

  9. Advertising for Demand Creation for Voluntary Medical Male Circumcision.

    PubMed

    Wilson, Nicholas; Frade, Sasha; Rech, Dino; Friedman, Willa

    2016-08-15

    To measure the effects of information, a challenge, and a conditional cash transfer on take-up of voluntary medical male circumcision (VMMC). A randomized, controlled experiment with 4000 postcard recipients in Soweto (Johannesburg), South Africa. We examined differences in take-up of several decisions in the VMMC cascade between the control arm and each of several intervention arms using logistic regression. Logistic regression analysis indicated that the group offered US $10 as compensation and the group challenged with "Are you tough enough?" had significantly higher take-up of the VMMC procedure than did the control group [odds ratios, respectively, 5.30 (CI: 2.20 to 12.76) and 2.70 (CI: 1.05 to 6.91)]. Similarly, the compensation group had significantly higher take-up of the VMMC counseling session than did the control group [odds ratio 3.76 (CI: 1.79 to 7.89)]. The analysis did not reveal significantly different take-up of either the VMMC counseling session or the procedure in the partner preference information group compared with the control group [odds ratios, respectively, 1.23 (CI: 0.51 to 2.97) and 1.67 (CI: 0.61 to 4.62)]. The analysis did not reveal significantly higher take-up of the VMMC nurse hotline in any intervention group compared with the control group [odds ratios for US $10, information, and challenge, respectively, 1.17 (CI: 0.67 to 2.07), 0.69 (CI: 0.36 to 1.32), and 0.60 (0.31 to 1.18)]. Among adult males in Soweto, South Africa, compensation of US $10 provided conditional on completing the VMMC counseling session compared with no compensation offer and a postcard with a challenge, "Are you tough enough?" compared with no challenge, resulted in moderate increases in take-up of circumcision.

  10. Social capital and self-rated health in Colombia: the good, the bad and the ugly.

    PubMed

    Hurtado, David; Kawachi, Ichiro; Sudarsky, John

    2011-02-01

    Although there is increasing evidence supporting the associations between social capital and health, less is known of potential effects in Latin American countries. Our objective was to examine associations of different components of social capital with self-rated health in Colombia. The study had a cross-sectional design, using data of a survey applied to a nationally representative sample of 3025 respondents, conducted in 2004-2005. Stratified random sampling was performed, based on town size, urban/rural origin, age, and sex. Examined indicators of social capital were interpersonal trust, reciprocity, associational membership, non-electoral political participation, civic activities and volunteering. Principal components analysis including different indicators of social capital distinguished three components: structural-formal (associational membership and non-electoral political participation), structural-informal (civic activities and volunteering) and cognitive (interpersonal trust and reciprocity). Multilevel analyses showed no significant variations of self-rated health at the regional level. After adjusting for sociodemographic covariates, interpersonal trust was statistically significantly associated with lower odds of poor/fair health, as well as the cognitive social capital component. Members of farmers/agricultural or gender-related groups had higher odds of poor/fair health, respectively. Excluding these groups, however, associational membership was associated with lower odds of poor/fair health. Likewise, in Colombians with educational attainment higher than high school, reciprocity was associated with lower odds of fair/poor health. Nevertheless, among rural respondents non-electoral political participation was associated with worse health. In conclusion, cognitive social capital and associational membership were related to better health, and could represent important notions for health promotion. Human rights violations related to political violence and gender based discrimination may explain adverse associations with health. Copyright © 2010 Elsevier Ltd. All rights reserved.

  11. Predictors of Over-Reporting HIV Pre-exposure Prophylaxis (PrEP) Adherence Among Young Men Who Have Sex With Men (YMSM) in Self-Reported Versus Biomarker Data.

    PubMed

    Baker, Zoë; Javanbakht, Marjan; Mierzwa, Stan; Pavel, Craig; Lally, Michelle; Zimet, Gregory; Gorbach, Pamina

    2018-04-01

    Young men who have sex with men (YMSM) face a disproportionately high burden of HIV. Oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV acquisition, but adherence to PrEP among YMSM may be inadequate. Medication adherence may be assessed via biomarkers, which are expensive and invasive, or via self-report through Audio Computer Assisted Self-Interview (ACASI), which may result in over-reporting of adherence. In this paper we assess the potential of a new method of self-report, the Interactive Questionnaire System (iQS), in validly estimating true adherence rates. PrEP adherence among 167 YMSM aged 15-23 was measured via dried blood spot (DBS), ACASI, and iQS twice over a 24-week study period. Both ACASI- and iQS-reported data revealed that over 40% of individuals self-reporting adequate PrEP adherence had DBS-estimated drug levels indicating inadequate adherence. Adjusted logistic repeated measures random intercept regression analyses indicated that younger YMSM had higher odds of over-reporting adherence than older YMSM-each 1 year increase in age was associated with 0.79 times the odds of over-reporting adherence (95% CI 0.63, 0.98; p value = 0.031), and being African American was associated with 3.22 times greater odds of over-reporting than non-African Americans (95% CI 1.51, 6.90; p-value = 0.0003). These results suggest that ACASI and iQS methods of self-report significantly overestimate true PrEP adherence rates among YMSM, and that the odds of over-reporting adherence may be affected by both age and race.

  12. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT).

    PubMed

    Bernhardt, Julie; Churilov, Leonid; Ellery, Fiona; Collier, Janice; Chamberlain, Jan; Langhorne, Peter; Lindley, Richard I; Moodie, Marj; Dewey, Helen; Thrift, Amanda G; Donnan, Geoff

    2016-06-07

    Our prespecified dose-response analyses of A Very Early Rehabilitation Trial (AVERT) aim to provide practical guidance for clinicians on the timing, frequency, and amount of mobilization following acute stroke. Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. We used regression analyses and Classification and Regression Trees (CART) to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group. A total of 2,104 patients were enrolled, of whom 2,083 (99.0%) were followed up at 3 months. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety outcomes with increased daily frequency of out-of-bed sessions (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.09 to 1.18, p < 0.001), keeping time to first mobilization and mobilization amount constant. Increased amount (minutes per day) of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p < 0.001). Session frequency was the most important variable in the CART analysis, after prognostic variables age and baseline stroke severity. These data suggest that shorter, more frequent mobilization early after acute stroke is associated with greater odds of favorable outcome at 3 months when controlling for age and stroke severity. This study provides Class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke. © 2016 American Academy of Neurology.

  13. Can cash break the cycle of educational risks for young children in high HIV–affected communities? A cross–sectional study in South Africa and Malawi

    PubMed Central

    Sherr, Lorraine; Tomlinson, Mark; Macedo, Ana; Skeen, Sarah; Hensels, Imca Sifra; Cluver, Lucie Dale

    2017-01-01

    Background Household cash grants are associated with beneficial outcomes; enhanced if provided in combination with care. Objectives This study describes the impact of cash grants and parenting quality on 854 children aged 5–15 (South African and Malawi) on educational outcomes including enrolment, regular attendance, correct class for age and school progress (controlling for cognitive performance). Consecutive attenders at randomly selected Community based organisations were recruited. The effects of cash plus good parenting, HIV status and gender were examined. Results Overall 73.1% received a grant – significantly less children with HIV (57.3% vs 75.6% (χ2 = 17.21, P < 0.001). Controlling for cognitive ability, grant receipt was associated with higher odds of being in the correct grade (odds ratio (OR) = 2.00; 95% confidence interval (CI) = 1.36, 2.95), higher odds of attending school regularly (OR = 3.62; 95% CI = 1.77, 7.40), and much higher odds of having missed less than a week of school recently (OR = 8.95; 95% CI = 2.27, 35.23). Grant receipt was not associated with how well children performed in school compared to their classmates or with school enrolment. Linear regression revealed that grant receipt was associated with a significant reduction in educational risk (B = –0.32, t(420) = 2.84, P = 0.005) for girls. Conclusion Cash plus good parenting affected some educational outcomes in a stepwise manner, but did not provide additive protection. PMID:29302316

  14. Adult weight gain and colorectal adenomas-a systematic review and meta-analysis.

    PubMed

    Schlesinger, S; Aleksandrova, K; Abar, L; Vieria, A R; Vingeliene, S; Polemiti, E; Stevens, C A T; Greenwood, D C; Chan, D S M; Aune, D; Norat, T

    2017-06-01

    Colorectal adenomas are known as precursors for the majority of colorectal carcinomas. While weight gain during adulthood has been identified as a risk factor for colorectal cancer, the association is less clear for colorectal adenomas. We conducted a systematic review and meta-analysis to quantify the evidence on this association. We searched Medline up to September 2016 to identify observational (prospective, cross-sectional and retrospective) studies on weight gain during adulthood and colorectal adenoma occurrence and recurrence. We conducted meta-analysis on high weight gain versus stable weight, linear and non-linear dose-response meta-analyses to analyze the association. Summary odds ratios (OR) and 95% confidence intervals (95% CI) were estimated using a random effects model. For colorectal adenoma occurrence, the summary OR was 1.39 (95% CI: 1.17-1.65; I2: 43%, N = 9 studies, cases = 5507) comparing high (midpoint: 17.4 kg) versus stable weight gain during adulthood and with each 5 kg weight gain the odds increased by 7% (2%-11%; I2: 65%, N = 7 studies). Although there was indication of non-linearity (Pnon-linearity < 0.001) there was an increased odds of colorectal adenoma throughout the whole range of weight gain. Three studies were identified investigating the association between weight gain and colorectal adenoma recurrence and data were limited to draw firm conclusions. Even a small amount of adult weight gain was related to a higher odds of colorectal adenoma occurrence. Our findings add to the benefits of weight control in adulthood regarding colorectal adenoma occurrence, which might be relevant for early prevention of colorectal cancer. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  15. Risk factors for Cryptosporidium infection in low and middle income countries: A systematic review and meta-analysis.

    PubMed

    Bouzid, Maha; Kintz, Erica; Hunter, Paul R

    2018-06-07

    Cryptosporidium infection causes gastrointestinal disease and has a worldwide distribution. The highest burden is in developing countries. We sought to conduct a systematic review and meta-analysis to identify Cryptosporidium risk factors in Low and Middle Income countries (LMICs). Medline Ovid and Scopus databases were searched with no restriction on year or language of publication. All references were screened independently in duplicate and were included if they presented data on at least 3 risk factors. Meta-analyses using random effects models were used to calculate overall estimates for each exposure. The most frequently reported risk factors in the 15 included studies were overcrowding, household diarrhoea, poor quality drinking water, animal contact, open defecation/ lack of toilet and breastfeeding. The combined odds ratio for animal contact was 1.98 (95%CI: 1.11-3.54) based on 11 studies and for diarrhoea in the household 1.98 (95%CI: 1.13-3.49) based on 4 studies. Open defecation was associated with a pooled odds ratio of 1.82 (95%CI: 1.19-2.8) based on 5 studies. Poor drinking water quality was not associated with a significant Cryptosporidium risk, odds ratio 1.06 (95%CI: 0.77-1.47). Breastfeeding was protective with pooled odds ratio 0.4 (95%CI: 0.13-1.22), which was not statistically significant. Based on the included studies, crowded living conditions, animal contact and open defecation are responsible for the majority of Cryptosporidium cases in LMICs. Future studies investigating Cryptosporidium risk factors should have a good study design and duration, include appropriate number of cases, select suitable controls, investigate multiple relevant risk factors, fully report data and perform multivariate analysis.

  16. Examining Contextual Influences on Fall-Related Injuries Among Older Adults for Population Health Management.

    PubMed

    Hoffman, Geoffrey J; Rodriguez, Hector P

    2015-12-01

    The objectives were to assess the associations between fall-related injuries (FRIs) treated in the emergency department (ED) among older adults in California and contextual county-level physical, social, and economic characteristics, and to assess how county-level economic conditions are associated with FRIs when controlling for other county-level factors. Data from 2008 California ED discharge, Medicare Impact File, and County Health Rankings were used. Random effects logistic regression models estimated contextual associations between county-level factors representing economic conditions, the built environment, community safety, access to care, and obesity with patient-level FRI treatment among 1,712,409 older adults, controlling for patient-level and hospital-level characteristics. Patient-level predictors of FRI treatment were consistent with previous studies not accounting for contextual associations. Larger and rural hospitals had higher odds of FRI treatment, while teaching and safety net hospitals had lower odds. Better county economic conditions were associated with greater odds (ß=0.73, P=0.001) and higher county-level obesity were associated with lower odds (ß=-0.37, P=0.004), but safer built environments (ß=-0.31, P=0.38) were not associated with FRI treatment. The magnitude of association between county-level economic conditions and FRI treatment attenuated with the inclusion of county-level obesity rates. FRI treatment was most strongly and consistently related to more favorable county economic conditions, suggesting differences in treatment or preferences for treatment for FRIs among older individuals in communities of varying resource levels. Using population health data on FRIs, policy makers may be able to remove barriers unique to local contexts when implementing falls prevention educational programs and built environment modifications.

  17. Examining Contextual Influences on Fall-Related Injuries Among Older Adults for Population Health Management

    PubMed Central

    Rodriguez, Hector P.

    2015-01-01

    Abstract The objectives were to assess the associations between fall-related injuries (FRIs) treated in the emergency department (ED) among older adults in California and contextual county-level physical, social, and economic characteristics, and to assess how county-level economic conditions are associated with FRIs when controlling for other county-level factors. Data from 2008 California ED discharge, Medicare Impact File, and County Health Rankings were used. Random effects logistic regression models estimated contextual associations between county-level factors representing economic conditions, the built environment, community safety, access to care, and obesity with patient-level FRI treatment among 1,712,409 older adults, controlling for patient-level and hospital-level characteristics. Patient-level predictors of FRI treatment were consistent with previous studies not accounting for contextual associations. Larger and rural hospitals had higher odds of FRI treatment, while teaching and safety net hospitals had lower odds. Better county economic conditions were associated with greater odds (ß=0.73, P=0.001) and higher county-level obesity were associated with lower odds (ß=−0.37, P=0.004), but safer built environments (ß=−0.31, P=0.38) were not associated with FRI treatment. The magnitude of association between county-level economic conditions and FRI treatment attenuated with the inclusion of county-level obesity rates. FRI treatment was most strongly and consistently related to more favorable county economic conditions, suggesting differences in treatment or preferences for treatment for FRIs among older individuals in communities of varying resource levels. Using population health data on FRIs, policy makers may be able to remove barriers unique to local contexts when implementing falls prevention educational programs and built environment modifications. (Population Health Management 2015;18:437–448) PMID:25919228

  18. Association between Inflammatory Bowel Disease and Vitamin D Deficiency: A Systematic Review and Meta-Analysis

    PubMed Central

    Del Pinto, Rita; Pietropaoli, Davide; Chandar, Apoorva Krishna; Ferri, Claudio; Cominelli, Fabio

    2015-01-01

    Background Vitamin D plays a role in several immune-mediated diseases, but its association with inflammatory bowel disease (IBD) is unclear. We conducted a systematic review and meta-analysis to assess the association between IBD and vitamin D deficiency. Methods We searched electronic databases from inception to December 2014 for observational studies reporting the presence of vitamin D deficiency (defined as serum 25-hydroxycholecalciferol [25(OH)D] level of ≤20 ng/ml) in IBD patients and having a control group without IBD. Odds ratios (OR) were combined using a random effects model. Meta-regression was performed using latitude as a moderator. Study quality was assessed using the Newcastle-Ottawa scale. Results Out of 816 citations, 14 eligible studies were identified, comprising 1891 participants (938 IBD cases and 953 controls). Meta-analysis showed that patients with IBD had 64% higher odds of vitamin D deficiency when compared to controls (OR = 1.64; 95% CI: 1.30, 2.08; I2 = 7%; p < 0.0001). UC patients had more than double the odds of vitamin D deficiency when compared to normal controls (OR = 2.28; 1.18, 4.41; I2 = 41%; p=0.01). Latitude did not influence the association between IBD and vitamin D deficiency (p = 0.34). Generalizability of our results might be limited as we summarized unadjusted ORs, due to non-availability of adjusted ORs in individual studies. Conclusions IBD is significantly associated with having higher odds of vitamin D deficiency. Well-designed RCTs and longitudinal studies are needed to further clarify the role of vitamin D in IBD pathogenesis and its therapy. PMID:26348447

  19. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT)

    PubMed Central

    Churilov, Leonid; Ellery, Fiona; Collier, Janice; Chamberlain, Jan; Langhorne, Peter; Lindley, Richard I.; Moodie, Marj; Dewey, Helen; Thrift, Amanda G.; Donnan, Geoff

    2016-01-01

    Objective: Our prespecified dose-response analyses of A Very Early Rehabilitation Trial (AVERT) aim to provide practical guidance for clinicians on the timing, frequency, and amount of mobilization following acute stroke. Methods: Eligible patients were aged ≥18 years, had confirmed first (or recurrent) stroke, and were admitted to a stroke unit within 24 hours of stroke onset. Patients were randomized to receive very early and frequent mobilization, commencing within 24 hours, or usual care. We used regression analyses and Classification and Regression Trees (CART) to investigate the effect of timing and dose of mobilization on efficacy and safety outcomes, irrespective of assigned treatment group. Results: A total of 2,104 patients were enrolled, of whom 2,083 (99.0%) were followed up at 3 months. We found a consistent pattern of improved odds of favorable outcome in efficacy and safety outcomes with increased daily frequency of out-of-bed sessions (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.09 to 1.18, p < 0.001), keeping time to first mobilization and mobilization amount constant. Increased amount (minutes per day) of mobilization reduced the odds of a good outcome (OR 0.94, 95% CI 0.91 to 0.97, p < 0.001). Session frequency was the most important variable in the CART analysis, after prognostic variables age and baseline stroke severity. Conclusion: These data suggest that shorter, more frequent mobilization early after acute stroke is associated with greater odds of favorable outcome at 3 months when controlling for age and stroke severity. Classification of evidence: This study provides Class III evidence that shorter, more frequent early mobilization improves the chance of regaining independence after stroke. PMID:26888985

  20. Job Offers to Individuals With Severe Mental Illness After Participation in Virtual Reality Job Interview Training.

    PubMed

    Smith, Matthew J; Fleming, Michael F; Wright, Michael A; Jordan, Neil; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D

    2015-11-01

    Individuals with severe mental illness have low employment rates, and the job interview presents a critical barrier for them to obtain competitive employment. Prior randomized controlled trials (RCTs) indicated that virtual reality job interview training (VR-JIT) improved job interviewing skills among trainees. This study assessed whether VR-JIT participation was associated with greater odds of receiving job offers in the six-months after completion of training. To assess the efficacy of VR-JIT, trainees (N=39) in the method and a comparison group (N=12) completed a brief survey approximately six months after participating in the RCTs. Primary vocational outcome measures included receiving a job offer and number of weeks searching for employment. A larger proportion of trainees than comparison participants received a job offer (51% versus 25%, respectively). Trainees were more likely to receive a job offer than comparison participants (odds ratio=9.64, p=.02) after analyses accounted for cognition, recency of last job, and diagnosis. Trainees had greater odds of receiving a job offer for each completed VR-JIT trial (odds ratio=1.41, p=.04), and a greater number of completed VR-JIT trials predicted fewer weeks of searching for employment (β=-.74, p=.02). Results provide preliminary support that VR-JIT is a promising intervention associated with enhanced vocational outcomes among individuals with severe mental illness. Given that participants had minimal access to standardized vocational services, future research could evaluate the effectiveness of VR-JIT among individuals with and without access to standardized vocational services as well as evaluate strategies to implement VR-JIT within a large community mental health service provider.

  1. Efficacy of preoperative biliary drainage in malignant obstructive jaundice: a meta-analysis and systematic review.

    PubMed

    Moole, Harsha; Bechtold, Matthew; Puli, Srinivas R

    2016-07-11

    In patients requiring surgical resection for malignant biliary jaundice, it is unclear if preoperative biliary drainage (PBD) would improve mortality and morbidity by restoration of biliary flow prior to operation. This is a meta-analysis to pool the evidence and assess the utility of PBD in patients with malignant obstructive jaundice. The primary outcome is comparing mortality outcomes in patients with malignant obstructive jaundice undergoing direct surgery (DS) versus PBD. The secondary outcomes include major adverse events and length of hospital stay in both the groups. Studies using PBD in patients with malignant obstructive jaundice were included in this study. For the data collection and extraction, articles were searched in MEDLINE, PubMed, Embase, Cochrane Central Register of Controlled Trials & Database of Systematic Reviews, etc. Pooled proportions were calculated using both Mantel-Haenszel method (fixed effects model) and DerSimonian-Laird method (random effects model). Initial search identified 2230 reference articles, of which 204 were selected and reviewed. Twenty-six studies (N = 3532) for PBD in malignant obstructive jaundice which met the inclusion criteria were included in this analysis. The odds ratio for mortality in PBD group versus DS group was 0.96 (95 % CI = 0.71 to 1.29). Pooled number of major adverse effects was lower in the PBD group at 10.40 (95 % CI = 9.96 to 10.83) compared to 15.56 (95 % CI = 15.06 to 16.05) in the DS group. Subgroup analysis comparing internal PBD to DS group showed lower odds for major adverse events (odds ratio, 0.48 with 95 % CI = 0.32 to 0.74). In patients with malignant biliary jaundice requiring surgery, PBD group had significantly less major adverse effects than DS group. Length of hospital stay and mortality rate were comparable in both the groups.

  2. Stress symptoms and frequency of sexual intercourse among young women.

    PubMed

    Hall, Kelli Stidham; Kusunoki, Yasamin; Gatny, Heather; Barber, Jennifer

    2014-08-01

    We have previously documented the relationships between stress and depression symptoms and adolescent women's nonuse and misuse of condoms and other contraceptive methods and on their unintended pregnancy rates. Here, we examine relationships between mental health symptoms and another understudied adolescent reproductive health behavior-frequency of sexual intercourse. Our outcome was weekly sexual intercourse activity. We used panel data from a longitudinal, population-based cohort study of 992 women ages 18-20. Weekly journals measured sociodemographic, relationship, reproductive, and mental health characteristics, sexual and contraceptive behaviors, and pregnancy history. We examined 27,130 surveys from 952 women during the first study year. Predictors of weekly sexual intercourse were moderate to severe stress (Perceived Stress Scale-4) and depression (Center for Epidemiologic Studies Depression Scale-5) symptoms measured at baseline. Multilevel, mixed-effects logistic regression models estimated the relationships between stress and depression symptoms and the weekly odds of sexual intercourse while adjusting for covariate fixed effects and random woman effects. Nearly a quarter of the sample had moderate to severe stress (23%) and depression (24%) symptoms at baseline. Women reported sexual intercourse in 36% of weeks. Proportions of sexually active weeks were higher among women with stress (43%) and depression (40%) compared with those without symptoms (35% and 35%, respectively; P values<0.001). Controlling for covariates, women with baseline stress symptoms had 1.6 times higher weekly odds of sexual intercourse compared with women without stress (adjusted odds ratio 1.6, confidence interval [1.1, 2.5]; P=0.04). Depression symptoms were not associated with sexual intercourse frequency in adjusted models. Stress symptoms were positively associated with sexual intercourse frequency among these young women. Research and practice efforts are needed to identify effective sexual health promotion and risk-reduction strategies, including contraceptive education and counseling, in the context of mental health symptoms and unintended pregnancy. © 2014 International Society for Sexual Medicine.

  3. Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial.

    PubMed

    Elfeddali, Iman; Bolman, Catherine; Candel, Math J J M; Wiers, Reinout W; de Vries, Hein

    2012-08-20

    Web-based computer-tailored approaches have the potential to be successful in supporting smoking cessation. However, the potential effects of such approaches for relapse prevention and the value of incorporating action planning strategies to effectively prevent smoking relapse have not been fully explored. The Stay Quit for You (SQ4U) study compared two Web-based computer-tailored smoking relapse prevention programs with different types of planning strategies versus a control group. To assess the efficacy of two Web-based computer-tailored programs in preventing smoking relapse compared with a control group. The action planning (AP) program provided tailored feedback at baseline and invited respondents to do 6 preparatory and coping planning assignments (the first 3 assignments prior to quit date and the final 3 assignments after quit date). The action planning plus (AP+) program was an extended version of the AP program that also provided tailored feedback at 11 time points after the quit attempt. Respondents in the control group only filled out questionnaires. The study also assessed possible dose-response relationships between abstinence and adherence to the programs. The study was a randomized controlled trial with three conditions: the control group, the AP program, and the AP+ program. Respondents were daily smokers (N = 2031), aged 18 to 65 years, who were motivated and willing to quit smoking within 1 month. The primary outcome was self-reported continued abstinence 12 months after baseline. Logistic regression analyses were conducted using three samples: (1) all respondents as randomly assigned, (2) a modified sample that excluded respondents who did not make a quit attempt in conformance with the program protocol, and (3) a minimum dose sample that also excluded respondents who did not adhere to at least one of the intervention elements. Observed case analyses and conservative analyses were conducted. In the observed case analysis of the randomized sample, abstinence rates were 22% (45/202) in the control group versus 33% (63/190) in the AP program and 31% (53/174) in the AP+ program. The AP program (odds ratio 1.95, P = .005) and the AP+ program (odds ratio 1.61, P = .049) were significantly more effective than the control condition. Abstinence rates and effects differed per sample. Finally, the results suggest a dose-response relationship between abstinence and the number of program elements completed by the respondents. Despite the differences in results caused by the variation in our analysis approaches, we can conclude that Web-based computer-tailored programs combined with planning strategy assignments and feedback after the quit attempt can be effective in preventing relapse 12 months after baseline. However, adherence to the intervention seems critical for effectiveness. Finally, our results also suggest that more research is needed to assess the optimum intervention dose. Dutch Trial Register: NTR1892; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1892 (Archived by WebCite at http://www.webcitation.org/693S6uuPM).

  4. Comparison of intervention effects in split-mouth and parallel-arm randomized controlled trials: a meta-epidemiological study

    PubMed Central

    2014-01-01

    Background Split-mouth randomized controlled trials (RCTs) are popular in oral health research. Meta-analyses frequently include trials of both split-mouth and parallel-arm designs to derive combined intervention effects. However, carry-over effects may induce bias in split- mouth RCTs. We aimed to assess whether intervention effect estimates differ between split- mouth and parallel-arm RCTs investigating the same questions. Methods We performed a meta-epidemiological study. We systematically reviewed meta- analyses including both split-mouth and parallel-arm RCTs with binary or continuous outcomes published up to February 2013. Two independent authors selected studies and extracted data. We used a two-step approach to quantify the differences between split-mouth and parallel-arm RCTs: for each meta-analysis. First, we derived ratios of odds ratios (ROR) for dichotomous data and differences in standardized mean differences (∆SMD) for continuous data; second, we pooled RORs or ∆SMDs across meta-analyses by random-effects meta-analysis models. Results We selected 18 systematic reviews, for 15 meta-analyses with binary outcomes (28 split-mouth and 28 parallel-arm RCTs) and 19 meta-analyses with continuous outcomes (28 split-mouth and 28 parallel-arm RCTs). Effect estimates did not differ between split-mouth and parallel-arm RCTs (mean ROR, 0.96, 95% confidence interval 0.52–1.80; mean ∆SMD, 0.08, -0.14–0.30). Conclusions Our study did not provide sufficient evidence for a difference in intervention effect estimates derived from split-mouth and parallel-arm RCTs. Authors should consider including split-mouth RCTs in their meta-analyses with suitable and appropriate analysis. PMID:24886043

  5. Cognitive behavioral therapy for anxiety and related disorders: A meta-analysis of randomized placebo-controlled trials.

    PubMed

    Carpenter, Joseph K; Andrews, Leigh A; Witcraft, Sara M; Powers, Mark B; Smits, Jasper A J; Hofmann, Stefan G

    2018-06-01

    The purpose of this study was to examine the efficacy of cognitive behavioral therapy (CBT) for anxiety-related disorders based on randomized placebo-controlled trials. We included 41 studies that randomly assigned patients (N = 2,843) with acute stress disorder, generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) to CBT or a psychological or pill placebo condition. Findings demonstrated moderate placebo-controlled effects of CBT on target disorder symptoms (Hedges' g = 0.56), and small to moderate effects on other anxiety symptoms (Hedges' g = 0.38), depression (Hedges' g = 0.31), and quality of life (Hedges' g = 0.30). Response rates in CBT compared to placebo were associated with an odds ratio of 2.97. Effects on the target disorder were significantly stronger for completer samples than intent-to-treat samples, and for individuals compared to group CBT in SAD and PTSD studies. Large effect sizes were found for OCD, GAD, and acute stress disorder, and small to moderate effect sizes were found for PTSD, SAD, and PD. In PTSD studies, dropout rates were greater in CBT (29.0%) compared to placebo (17.2%), but no difference in dropout was found across other disorders. Interventions primarily using exposure strategies had larger effect sizes than those using cognitive or cognitive and behavioral techniques, though this difference did not reach significance. Findings demonstrate that CBT is a moderately efficacious treatment for anxiety disorders when compared to placebo. More effective treatments are especially needed for PTSD, SAD, and PD. © 2018 Wiley Periodicals, Inc.

  6. Can even-order laser harmonics exhibited by Bohmian trajectories in symmetric potentials be observed?

    PubMed

    Peatross, J; Johansen, J

    2014-01-13

    Strong-field laser-atom interactions provide extreme conditions that may be useful for investigating the de Broglie-Bohm quantum interpretation. Bohmian trajectories representing bound electrons in individual atoms exhibit both even and odd harmonic motion when subjected to a strong external laser field. The phases of the even harmonics depend on the random initial positions of the trajectories within the wave function, making the even harmonics incoherent. In contrast, the phases of odd harmonics remain for the most part coherent regardless of initial position. Under the conjecture that a Bohmian point particle plays the role of emitter, this suggests an experiment to determine whether both even and odd harmonics are produced at the atomic level. Estimates suggest that incoherent emission of even harmonics may be detectable out the side of an intense laser focus interacting with a large number of atoms.

  7. Childhood adiposity and risk of type 1 diabetes: A Mendelian randomization study

    PubMed Central

    Todd, John A.

    2017-01-01

    Background The incidence of type 1 diabetes (T1D) is increasing globally. One hypothesis is that increasing childhood obesity rates may explain part of this increase, but, as T1D is rare, intervention studies are challenging to perform. The aim of this study was to assess this hypothesis with a Mendelian randomization approach that uses genetic variants as instrumental variables to test for causal associations. Methods and findings We created a genetic instrument of 23 single nucleotide polymorphisms (SNPs) associated with childhood adiposity in children aged 2–10 years. Summary-level association results for these 23 SNPs with childhood-onset (<17 years) T1D were extracted from a meta-analysis of genome-wide association study with 5,913 T1D cases and 8,828 reference samples. Using inverse-variance weighted Mendelian randomization analysis, we found support for an effect of childhood adiposity on T1D risk (odds ratio 1.32, 95% CI 1.06–1.64 per standard deviation score in body mass index [SDS-BMI]). A sensitivity analysis provided evidence of horizontal pleiotropy bias (p = 0.04) diluting the estimates towards the null. We therefore applied Egger regression and multivariable Mendelian randomization methods to control for this type of bias and found evidence in support of a role of childhood adiposity in T1D (odds ratio in Egger regression, 2.76, 95% CI 1.40–5.44). Limitations of our study include that underlying genes and their mechanisms for most of the genetic variants included in the score are not known. Mendelian randomization requires large sample sizes, and power was limited to provide precise estimates. This research has been conducted using data from the Early Growth Genetics (EGG) Consortium, the Genetic Investigation of Anthropometric Traits (GIANT) Consortium, the Tobacco and Genetics (TAG) Consortium, and the Social Science Genetic Association Consortium (SSGAC), as well as meta-analysis results from a T1D genome-wide association study. Conclusions This study provides genetic support for a link between childhood adiposity and T1D risk. Together with evidence from observational studies, our findings further emphasize the importance of measures to reduce the global epidemic of childhood obesity and encourage mechanistic studies. PMID:28763444

  8. Effect of enhanced biosecurity and selected on-farm factors on Campylobacter colonization of chicken broilers.

    PubMed

    Georgiev, M; Beauvais, W; Guitian, J

    2017-02-01

    Human campylobacteriosis is the most commonly reported gastrointestinal bacterial infection in the EU; poultry meat has been identified as the main source of infection. We tested the hypothesis that enhanced biosecurity and other factors such as welfare status, breed, the practice of partial depopulation and number of empty days between flocks may prevent Campylobacter spp. caecal colonization of poultry batches at high levels (>123 000 c.f.u./g in pooled caecal samples). We analysed data from 2314 poultry batches sampled at slaughter in the UK in 2011-2013. We employed random-effects logistic regression to account for clustering of batches within farms and adjust for confounding. We estimated population attributable fractions using adjusted risk ratios. Enhanced biosecurity reduced the odds of colonization at partial depopulation [odds ratio (OR) 0·25, 95% confidence interval (CI) 0·14-0·47] and, to a lesser extent, at final depopulation (OR 0·47, 95% CI 0·25-0·89). An effect of the type of breed was also found. Under our assumptions, approximately 1/3 of highly colonized batches would be avoided if they were all raised under enhanced biosecurity or without partial depopulation. The results of the study indicate that on-farm measures can play an important role in reducing colonization of broiler chickens with Campylobacter spp. and as a result human exposure.

  9. Effect of music on level of anxiety in patients undergoing colonoscopy without sedation.

    PubMed

    Ko, Chia-Hui; Chen, Yi-Yu; Wu, Kuan-Ta; Wang, Shu-Chi; Yang, Jeng-Fu; Lin, Yu-Yin; Lin, Chia-I; Kuo, Hsiang-Ju; Dai, Chia-Yen; Hsieh, Meng-Hsuan

    2017-03-01

    Listening to music can be a noninvasive method for reducing the anxiety level without any adverse effects. The aim of this study was to explore whether music can reduce anxiety and to compare two different styles of music, informal classical music and light music, to ascertain the more effective style of music in reducing anxiety in patients undergoing colonoscopy without sedation. This study enrolled 138 patients who underwent colonoscopy without sedation during a general health examination from February 2009 to January 2015. The patients were randomly assigned to a group that did not listen to music, a group that listened to music by David Tolley, or a group that listened to music by Kevin Kern. The State-Trait Anxiety Inventory was used to evaluate the status of anxiety. A trend test for mild anxiety was performed on the patients in the three groups, and a significant trend was noted (p=0.017 for all patients; p=0.014 for analysis by sex). Multivariate analysis for mild anxiety on the patients in each group was also performed in this study, and music by Kevin Kern was found to have the lowest odds ratio (Odds ratio=0.34, p=0.045). Listening to music, especially music by Kevin Kern, reduced the level of anxiety in patients undergoing colonoscopy examination without sedation. Copyright © 2016. Published by Elsevier Taiwan LLC.

  10. The association of hyperglycemia and diabetes mellitus and the risk of chemotherapy-induced neutropenia among cancer patients: A systematic review with meta-analysis.

    PubMed

    Alenzi, Ebtihag O; Kelley, George A

    2017-01-01

    Conduct a systematic review with meta-analysis to determine the association between incident chemotherapy-induced neutropenia (CIN) and either diabetes mellitus (DM) or hyperglycemia in patients with cancer. Observational studies in cancer patients of any age receiving chemotherapy and having diabetes or hyperglycemia either during or before chemotherapy induction were included. Studies were retrieved by searching four databases (PubMed, EBSCO, ProQuest, and Cochrane) and cross-referencing. The metric for combining studies was the odds ratio (OR). Results were pooled using a random-effects model, while heterogeneity and inconsistency were assessed using the Q and I 2 statistic, respectively. Potential small-study effects were assessed using the funnel plot. Ten studies met the criteria for inclusion. Overall, the odds of having CIN were 32% higher among cancer patients with either DM or hyperglycemia compared with those without DM or hyperglycemia (OR=1.32, 95% CI, 1.06-1.64). Statistically significant heterogeneity and inconsistency were found (Q=33.15, p<0.05, I 2 =72.9%). Funnel plot asymmetry reflecting potential small-study effects was observed. Diabetes mellitus and hyperglycemia may be associated with an increased risk for CIN among cancer patients. However, additional well-designed studies are needed before any final and definitive recommendations can be made. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Unemployment in chronic airflow obstruction around the world: results from the BOLD study.

    PubMed

    Grønseth, Rune; Erdal, Marta; Tan, Wan C; Obaseki, Daniel O; Amaral, Andre F S; Gislason, Thorarinn; Juvekar, Sanjay K; Koul, Parvaiz A; Studnicka, Michael; Salvi, Sundeep; Burney, Peter; Buist, A Sonia; Vollmer, William M; Johannessen, Ane

    2017-09-01

    We aimed to examine associations between chronic airflow obstruction (CAO) and unemployment across the world.Cross-sectional data from 26 sites in the Burden of Obstructive Lung Disease (BOLD) study were used to analyse effects of CAO on unemployment. Odds ratios for unemployment in subjects aged 40-65 years were estimated using a multilevel mixed-effects generalised linear model with study site as random effect. Site-by-site heterogeneity was assessed using individual participant data meta-analyses.Out of 18 710 participants, 11.3% had CAO. The ratio of unemployed subjects with CAO divided by subjects without CAO showed large site discrepancies, although these were no longer significant after adjusting for age, sex, smoking and education. The site-adjusted odds ratio (95% CI) for unemployment was 1.79 (1.41-2.27) for CAO cases, decreasing to 1.43 (1.14-1.79) after adjusting for sociodemographic factors, comorbidities and forced vital capacity. Of other covariates that were associated with unemployment, age and education were important risk factors in high-income sites (4.02 (3.53-4.57) and 3.86 (2.80-5.30), respectively), while female sex was important in low- to middle-income sites (3.23 (2.66-3.91)).In the global BOLD study, CAO was associated with increased levels of unemployment, even after adjusting for sociodemographic factors, comorbidities and lung function. Copyright ©ERS 2017.

  12. Does Stress Result in You Exercising Less? Or Does Exercising Result in You Being Less Stressed? Or Is It Both? Testing the Bi-directional Stress-Exercise Association at the Group and Person (N of 1) Level.

    PubMed

    Burg, Matthew M; Schwartz, Joseph E; Kronish, Ian M; Diaz, Keith M; Alcantara, Carmela; Duer-Hefele, Joan; Davidson, Karina W

    2017-12-01

    Psychosocial stress contributes to heart disease in part by adversely affecting maintenance of health behaviors, while exercise can reduce stress. Assessing the bi-directional relationship between stress and exercise has been limited by lack of real-time data and theoretical and statistical models. This lack may hinder efforts to promote exercise maintenance. We test the bi-directional relationship between stress and exercise using real-time data for the average person and the variability-individual differences-in this relationship. An observational study was conducted within a single cohort randomized controlled experiment. Healthy young adults, (n = 79) who reported only intermittent exercise, completed 12 months of stress monitoring by ecological momentary assessment (at the beginning of, end of, and during the day) and continuous activity monitoring by Fitbit. A random coefficients linear mixed model was used to predict end-of-day stress from the occurrence/non-occurrence of exercise that day; a logistic mixed model was used to predict the occurrence/non-occurrence of exercise from ratings of anticipated stress. Separate regression analyses were also performed for each participant. Sensitivity analysis tested all models, restricted to the first 180 days of observation (prior to randomization). We found a significant average inverse (i.e., negative) effect of exercise on stress and of stress on exercise. There was significant between-person variability. Of N = 69, exercise was associated with a stress reduction for 15, a stress increase for 2, and no change for the remainder. We also found that an increase in anticipated stress reported the previous night or that morning was associated with a significant 20-22% decrease (OR = 0.78-0.80) in the odds of exercising that day. Of N = 69, this increase in stress reduced the likelihood of exercise for 17, increased the odds for 1, and had no effect for the remainder. We were unable to identify psychosocial factors that moderate the individual differences in these effects. The relationship of stress to exercise can be uni- or bi-directional and varies from person to person. A precision medicine approach may improve exercise uptake.

  13. Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

    PubMed

    Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

    2011-04-01

    Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P < .001) and griseofulvin was more efficacious than terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P < .001). Both griseofulvin and terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the subgroup analysis of Microsporum species, data from only 3 studies were available. This meta-analysis suggests that terbinafine is more efficacious than griseofulvin in treating tinea capitis caused by Trichophyton species, whereas griseofulvin is more efficacious than terbinafine in treating tinea capitis caused by Microsporum species. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  14. Neuraxial and Combined Neuraxial/General Anesthesia Compared to General Anesthesia for Major Truncal and Lower Limb Surgery: A Systematic Review and Meta-analysis.

    PubMed

    Smith, Lauren M; Cozowicz, Crispiana; Uda, Yoshiaki; Memtsoudis, Stavros G; Barrington, Michael J

    2017-12-01

    Neuraxial anesthesia may improve perioperative outcomes when compared to general anesthesia; however, this is controversial. We performed a systematic review and meta-analysis using randomized controlled trials and population-based observational studies identified in MEDLINE, PubMed, and EMBASE from 2010 to May 31, 2016. Studies were included for adult patients undergoing major surgery of the trunk and lower extremity that reported: 30-day mortality (primary outcome), cardiopulmonary morbidity, surgical site infection, thromboembolic events, blood transfusion, and resource use. Perioperative outcomes were compared with general anesthesia for the following subgroups: combined neuraxial-general anesthesia and neuraxial anesthesia alone. Odds ratios (ORs) and 99% confidence intervals (CIs) were calculated to identify the impact of anesthetic technique on outcomes. Twenty-seven observational studies and 11 randomized control trials were identified. This analysis comprises 1,082,965 records from observational studies or databases and 1134 patients from randomized controlled trials. There was no difference in 30-day mortality identified when combined neuraxial-general anesthesia was compared with general anesthesia (OR 0.88; 99% CI, 0.77-1.01), or when neuraxial anesthesia was compared with general anesthesia (OR 0.98; 99% CI, 0.92-1.04). When combined neuraxial-general anesthesia was compared with general anesthesia, combined neuraxial-general anesthesia was associated with a reduced odds of pulmonary complication (OR 0.84; 99% CI, 0.79-0.88), surgical site infection (OR 0.93; 99% CI, 0.88-0.98), blood transfusion (OR 0.90; 99% CI, 0.87-0.93), thromboembolic events (OR 0.84; 99% CI, 0.73-0.98), length of stay (mean difference -0.16 days; 99% CI, -0.17 to -0.15), and intensive care unit admission (OR 0.77; 99% CI, 0.73-0.81). For the combined neuraxial-general anesthesia subgroup, there were increased odds of myocardial infarction (OR 1.18; 99% CI, 1.01-1.37). There was no difference identified in the odds of pneumonia (OR 0.94; 99% CI, 0.87-1.02) or cardiac complications (OR 1.04; 99% CI, 1.00-1.09) for the combined neuraxial-general anesthesia subgroup. When neuraxial anesthesia was compared to general anesthesia, there was a decreased odds of any pulmonary complication (OR 0.38; 99% CI, 0.36-0.40), surgical site infection (OR 0.76; 99% CI, 0.71-0.82), blood transfusion (OR 0.85; 99% CI, 0.82-0.88), thromboembolic events (OR 0.79; 99% CI, 0.68-0.91), length of stay (mean difference -0.29 days; 99% CI, -0.29 to -0.28), and intensive care unit admission (OR 0.50; 99% CI, 0.48-0.53). There was no difference in the odds of cardiac complications (OR 0.99; 99% CI, 0.94-1.03), myocardial infarction (OR 0.91; 99% CI, 0.81-1.02), or pneumonia (OR 0.92; 99% CI, 0.84-1.01). Randomized control trials revealed no difference in requirement for blood transfusion (RR 1.05; 99% CI, 0.65-1.71) and a decreased length of stay (mean difference -0.15 days; 99% CI, -0.27 to -0.04). Neuraxial anesthesia when combined with general anesthesia or when used alone was not associated with decreased 30-day mortality. Neuraxial anesthesia may improve pulmonary outcomes and reduce resource use when compared with general anesthesia. However, because observational studies were included in this analysis, there is a risk of residual confounding and therefore these results should be interpreted with caution.

  15. The effect of laser-assisted hatching on pregnancy outcomes of cryopreserved-thawed embryo transfer: a meta-analysis of randomized controlled trials.

    PubMed

    Zeng, MeiFang; Su, SuQin; Li, LiuMing

    2018-04-01

    It is well known that laser-assisted hatching (LAH) is the most popular and ideal embryo hatching technology, but the relevance to pregnancy outcomes of cryopreserved-thawed embryo transfer (ET) is controversial. The purpose of this meta-analysis was to evaluate the effects of LAH on pregnancy outcomes of cryopreserved-thawed ET. We searched for relevant studies published in the PubMed, EMBASE, and Cochrane Central databases up to March 2017. This meta-analysis was primarily used to evaluate the effect of laser-assisted hatching on assisted reproductive outcomes: clinical pregnancy, embryo implantation, multiple pregnancy, miscarriage, and live birth. Using the Mantel-Haenszel fixed effects model and random effects model, we determined the summary odds ratios (OR) with 95% confidence intervals (CIs). There were 12 randomized controlled trials (more than 2574 participants) included in our analysis. The rates of clinical pregnancy (OR = 1.65, 95% CI = 1.24-2.19, I 2  = 49), implantation (OR = 1.59, 95% CI = 1.06-2.38, I 2  = 82%), multiple pregnancy (OR = 2.30, 95% CI = 1.30-4.07, I 2  = 33%), miscarriage (OR = 0.86, 95% CI = 0.50-1.48, I 2  = 0%), and live birth (OR = 1.09, 95% CI = 0.77-1.54, I 2  = 0%) revealed comparable results for both groups. In summary, this meta-analysis demonstrates that LAH is related to a higher clinical pregnancy rate, embryo implantation rate, and multiple pregnancy rate in women with cryopreserved-thawed embryos. However, LAH is unlikely to increase live birth rates and miscarriage rates. Due to the small sample evaluated in the pool of included studies, large-scale, prospective, randomized, controlled trials are required to determine if these small effects are clinically relevant.

  16. [Four numbers and a bit more basic knowledge of mathematics].

    PubMed

    Günther, Judith; Briel, Matthias; Suter, Katja

    2015-02-01

    In addition to relative risk, relative risk reduction and absolute risk reduction there circulates another effect size for binary endpoints in the scientific medical literature: the odds ratio. Relative risk and odds ratio are alternative ways of reflecting study results. Both, relative risk (RR) and odds ratio (OR), can easily be calculated from the "2 x 2-table". Advantage of OR: odds ratios can be calculated in every type of controlled study design, including retrospective studies. Furthermore, odds ratios--the biostatisticians are swarming--offer beautiful mathematical properties and therefore are often used in meta-analysis as an effect size for calculating a pooled estimate of the results of different studies with the same clinical question. Disadvantage of OR: In clinical studies the presentation of the results as "odds ratios" may result in an overestimation of the intervention effect. This article shows the difference between "chance" and "risk" and how odds ratio and relative risk are associated.

  17. Effects on abstinence of nicotine patch treatment before quitting smoking: parallel, two arm, pragmatic randomised trial.

    PubMed

    2018-06-13

    To examine the effectiveness of a nicotine patch worn for four weeks before a quit attempt. Randomised controlled open label trial. Primary care and smoking cessation clinics in England, 2012-15. 1792 adults who were daily smokers with tobacco dependence. 899 were allocated to the preloading arm and 893 to the control arm. Participants were randomised 1:1, using concealed randomly permuted blocks stratified by centre, to either standard smoking cessation pharmacotherapy and behavioural support or the same treatment supplemented by four weeks of 21 mg nicotine patch use before quitting: "preloading." The primary outcome was biochemically confirmed prolonged abstinence at six months. Secondary outcomes were prolonged abstinence at four weeks and 12 months. Biochemically validated abstinence at six months was achieved by 157/899 (17.5%) participants in the preloading arm and 129/893 (14.4%) in the control arm: difference 3.0% (95% confidence interval -0.4% to 6.4%), odds ratio 1.25 (95% confidence interval 0.97 to 1.62), P=0.08 in the primary analysis. There was an imbalance between arms in the frequency of varenicline use as post-cessation treatment, and planned adjustment for this gave an odds ratio for the effect of preloading of 1.34 (95% confidence interval 1.03 to 1.73), P=0.03: difference 3.8% (0.4% to 7.2%). At four weeks, the difference in prolonged abstinence unadjusted for varenicline use was odds ratio 1.21 (1.00 to 1.48), difference 4.3% (0.0% to 8.7%), P=0.05, and adjusted for varenicline use was 1.32 (1.08 to 1.62) P=0.007. At 12 months the odds ratio was 1.28 (0.97 to 1.69), difference 2.7% (-0.4% to 5.8%), P=0.09 unadjusted for varenicline use and after adjustment was 1.36 (1.02 to 1.80) P=0.04. 5.9% of participants discontinued preloading owing to intolerance. Gastrointestinal symptoms-chiefly nausea-occurred in 4.0% (2.2% to 5.9%) more people in the preloading arm than control arm. Eight serious adverse events occurred in the preloading arm and eight in the control arm (odds ratio 0.99, 0.36 to 2.75). Evidence was insufficient to confidently show that nicotine preloading increases subsequent smoking abstinence. The beneficial effect seems to have been masked by a concurrent reduction in the use of varenicline in people using nicotine preloading, and future studies should explore ways to mitigate this unintended effect. Current Controlled Trials ISRCTN33031001. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Feminism, status inconsistency, and women's intimate partner victimization in heterosexual relationships.

    PubMed

    Franklin, Cortney A; Menaker, Tasha A

    2014-07-01

    This study used a random community sample of 303 women in romantic relationships to investigate the role of educational and employment status inconsistency and patriarchal family ideology as risk factors for intimate partner violence (IPV) victimization, while considering demographic factors and relationship context variables. Sequential multivariate logistic regression models demonstrated a decrease in the odds of IPV victimization for Hispanic women and women who were older as compared with their counterparts. In addition, increased relationship distress, family-of-origin violence, and employment status inconsistency significantly increased the odds of IPV. Clinical intervention strategies and future research directions are discussed. © The Author(s) 2014.

  19. The use of household cleaning products during pregnancy and lower respiratory tract infections and wheezing during early life.

    PubMed

    Casas, Lidia; Zock, Jan Paul; Carsin, Anne Elie; Fernandez-Somoano, Ana; Esplugues, Ana; Santa-Marina, Loreto; Tardón, Adonina; Ballester, Ferran; Basterrechea, Mikel; Sunyer, Jordi

    2013-10-01

    To evaluate the effects of household use of cleaning products during pregnancy on infant wheezing and lower respiratory tract infections (LRTI). In four prospective Spanish birth cohorts (n = 2,292), pregnant women reported the use of household cleaning products. When infants were 12-18 months old, current cleaning product use and infant's wheezing and LRTI were reported. Cohort-specific associations between the use of specific products and respiratory outcomes were evaluated using multivariable regression analyses and estimates were combined using random-effects meta-analyses. The period prevalence of LRTI was higher when sprays (combined odds ratio (OR) = 1.29; 95 % confidence interval (CI) 1.04-1.59) or air fresheners (OR = 1.29; CI 1.03-1.63) were used during pregnancy. The odds of wheezing increased with spray (OR = 1.37; CI 1.10-1.69) and solvent (OR = 1.30; CI 1.03-1.62) use. The associations between spray and air freshener use during pregnancy and both outcomes remained apparent when these products were not used after pregnancy. Nevertheless, the estimates were higher when post-natal exposure was included. The use of cleaning sprays, air fresheners and solvents during pregnancy may increase the risk of wheezing and infections in the offspring.

  20. Beta-Blockers (Carvedilol) in Children with Systemic Ventricle Systolic Dysfunction - Systematic Review and Meta-Analysis.

    PubMed

    Prijic, Sergej; Buchhorn, Reiner; Kosutic, Jovan; Vukomanovic, Vladislav; Prijic, Andreja; Bjelakovic, Bojko; Zdravkovic, Marija

    2014-01-01

    Numerous prospective randomized clinical trials demonstrated favorable effect of beta-blockers in adults with chronic heart failure. However, effectiveness of beta blockers in pediatric patients with systemic ventricle systolic dysfunction was not recognized sufficiently. Limited number of pediatric patients might be the course of unrecognized carvediolol treatment benefit. Currently, no meta-analysis has examined the impact of carvedilol and conventional therapy on the clinical outcome in children with chronic heart failure due to impaired systemic ventricle systolic function. We have systematically searched the Medline/PubMed and Cochrane Library for the controlled clinical trials that examine carvedilol and standard treatment efficacy in pediatric patients with systemic ventricle systolic dysfunction. Mean differences for continuous variables, odds ratios for dichotomous outcomes, heterogeneity between studies and publication bias were calculated using Cochrane Review Manager (Rev Man 5.2). Total of 8 prospective/observational studies met established criteria. Odds ratio for chronic heart failure related mortality/heart transplantation secondary to carvedilol was 0.52 (95% CI: 0.28-0.97, I(2) = 0%). Our analysis showed that carvedilol could prevent 1 death/ heart transplantation by treating 14 pediatric patients with impaired systemic ventricle systolic function. Meta-analysis demonstrated clinical outcome benefit of carvedilol in children with chronic heart failure.

  1. Sedentary behavior is associated with colorectal adenoma recurrence in men

    PubMed Central

    Molmenti, Christine L. Sardo; Hibler, Elizabeth A.; Ashbeck, Erin L.; Thomson, Cynthia A.; Garcia, David O.; Roe, Denise; Harris, Robin B.; Lance, Peter; Cisneroz, Martin; Martinez, Maria Elena; Thompson, Patricia A.; Jacobs, Elizabeth T.

    2014-01-01

    Purpose The association between physical activity and colorectal adenoma is equivocal. This study was designed to assess the relationship between physical activity and colorectal adenoma recurrence. Methods Pooled analyses from two randomized, controlled trials included 1,730 participants who completed the Arizona Activity Frequency Questionnaire at baseline, had a colorectal adenoma removed within 6 months of study registration, and had a follow-up colonoscopy during the trial. Logistic regression modeling was employed to estimate the effect of sedentary behavior, light-intensity physical activity, and moderate-vigorous physical activity on colorectal adenoma recurrence. Results No statistically significant trends were found for any activity type and odds of colorectal adenoma recurrence in the pooled population. However, males with the highest levels of sedentary time experienced 47% higher odds of adenoma recurrence. Compared to the lowest quartile of sedentary time, the ORs (95% CIs) for the second, third, and fourth quartiles among men were 1.23 (0.88, 1.74), 1.41 (0.99, 2.01), and 1.47 (1.03, 2.11) respectively (P trend=0.03). No similar association was observed for women. Conclusions This study suggests that sedentary behavior is associated with a higher risk of colorectal adenoma recurrence among men, providing evidence of detrimental effects of a sedentary lifestyle early in the carcinogenesis pathway. PMID:25060482

  2. Secondhand smoke exposure in the workplace.

    PubMed

    Skeer, Margie; Cheng, Debbie M; Rigotti, Nancy A; Siegel, Michael

    2005-05-01

    Currently, there is little understanding of the relationship between the strength of workplace smoking policies and the likelihood and duration, not just the likelihood, of exposure to secondhand smoke at work. This study assessed self-reported exposure to secondhand smoke at work in hours per week among a cross-sectional sample of 3650 Massachusetts adults who were employed primarily at a single worksite outside the home that was not mainly outdoors. The sample data were from a larger longitudinal study designed to examine the effect of community-based tobacco control interventions on adult and youth smoking behavior. Participants were identified through a random-digit-dialing telephone survey. Multiple logistic regression and zero-inflated negative binomial regression models were used to estimate the independent effect of workplace smoking policies on the likelihood and duration of exposure to secondhand smoke. Compared to employees whose workplace banned smoking completely, those whose workplace provided designated smoking areas had 2.9 times the odds of being exposed to secondhand smoke and 1.74 times the duration of exposure, while those with no restrictions had 10.27 times the odds of being exposed and 6.34 times the duration of exposure. Workplace smoking policies substantially reduce the likelihood of self-reported secondhand smoke exposure among employees in the workplace and also greatly affect the duration of exposure.

  3. Efficacy and safety of ceftriaxone for uncomplicated gonorrhoea: a meta-analysis of randomized controlled trials.

    PubMed

    Bai, Z-G; Bao, X-J; Cheng, W-D; Yang, K-H; Li, Y-P

    2012-02-01

    We conducted a systematic review and meta-analysis of ceftriaxone for treatment of uncomplicated gonorrhoea compared with four other antibiotics. Thirteen randomized controlled trials (RCTs) totalling treatment of 2557 patients with uncomplicated gonorrhoea were included. Statistically significant differences were observed in side-effects, which were increased after ceftriaxone 250 mg versus cefotaxime 500 mg (odds ratio [OR] 1.87; 95% confidence interval [CI] 1.14-3.08). Cure rates of ceftriaxone 250 mg were significantly better than cefixime 400 mg (OR 1.77; 95% CI 1.11-2.80) as was ceftriaxone 125 mg versus spectinomycin 2 g (OR 3.44; 95% CI 1.08-10.90). There was no statistically significant difference between ceftriaxone 250 mg and cefixime 800 mg in cure rates (OR 1.39; 95% CI 0.92-2.10) or adverse effects (OR 1.29, 95% CI 0.58-2.84) for treating uncomplicated gonorrhoea. The cure rate after ceftriaxone 250 mg was not significantly different from that after spectinomycin 2 g (OR 1.96; 95% CI 1.00-3.87). In conclusion, this meta-analysis revealed that 250 mg ceftriaxone had a higher efficacy than 400 mg cefixime for uncomplicated gonorrhoea. Also, ceftriaxone 125 mg is a better choice than spectinomycin 2 g for patients with uncomplicated gonorrhoea, but ceftriaxone had higher side-effect rates than cefotaxime. In the current era further randomized controlled clinical trials of ceftriaxone for uncomplicated gonorrhoea are warranted.

  4. Does high-flow nasal cannula oxygen improve outcome in acute hypoxemic respiratory failure? A systematic review and meta-analysis.

    PubMed

    Lin, Si-Ming; Liu, Kai-Xiong; Lin, Zhi-Hong; Lin, Pei-Hong

    2017-10-01

    To evaluate the efficacy of high-flow nasal cannula (HFNC) in the rate of intubation and mortality for patients with acute hypoxemic respiratory failure. We searched Pubmed, EMBASE, and the Cochrane Library for relevant studies. Two reviewers extracted data and reviewed the quality of the studies independently. The primary outcome was the rate of intubation; secondary outcome was mortality in the hospital. Study-level data were pooled using a random-effects model when I2 was >50% or a fixed-effects model when I2 was <50%. Eight randomized controlled studies with a total of 1,818patients were considered. Pooled analysis showed that no statistically significant difference was found between groups regarding the rate of intubation (odds ratio [OR] = 0.79; 95% confidence interval [CI]: 0.60-1.04; P = 0.09; I2 = 36%) and no statistically significant difference was found between groups regarding hospital mortality (OR = 0.89; 95% CI: 0.62-127; P = 0.51; I2 = 47%). The use of HFNC showed a trend toward reduction in the intubation rate, which did not meet statistical significance, in patients with acute respiratory failure compared with conventional oxygen therapy (COT) and noninvasive ventilation (NIV). Moreover no difference in mortality. So, Large, well-designed, randomized, multi-center trials are needed to confirm the effects of HFNC in acute hypoxemic respiratory failure patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Comparison of the effectiveness of whole-brain radiotherapy plus temozolomide versus whole-brain radiotherapy in treating brain metastases based on a systematic review of randomized controlled trials.

    PubMed

    Bai, Gui-Rong; An, Jin-Bing; Chu, Yang; Wang, Xiang-Yang; Li, Shu-Ming; Yan, Kai-Jing; Lü, Fu-Rong; Gu, Ning; Griffin, Amanda N; Sun, Bin-Yuan; Li, Wei; Wang, Guo-Cheng; Zhou, Shui-Ping; Sun, He; Liu, Chang-Xiao

    2016-01-01

    Temozolomide (TMZ) combination with whole-brain radiotherapy (WBRT) has been tested by many randomized controlled trials in the treatment of brain metastases (BMs) in China and other countries. We performed an up-to-date meta-analysis to determine (i) the log odds ratios (LORs) of objective response (ORR) and adverse effects (AEs) for all-grade, and (ii) the T value of mean overall survival in patients with BMs treated with WBRT combined with TMZ versus WBRT alone. PubMed, Chinese National Knowledge Infrastructure, and WanFang Data were searched for articles published up to 28 January 2015. Eligible studies were selected according to the PRISMA statement. ORR, AEs, and 95% confidence intervals were calculated using random-effects models. Eighteen studies were included in our analysis. A total of 1028 participants were enrolled. Summary LORs of ORR were 1.0239 (P<0.0001) on comparing WBRT plus TMZ with WBRT ORR (n=17). The overall mean difference of mean overall survival (n=17) between TMZ plus WBRT and WBRT was 2.2505 weeks (P=0.02185). There was a significant difference between WBRT plus TMZ and WBRT alone with a LOR of AEs for all-grade of (i) 0.923 for gastrointestinal toxicity and (ii) 0.7978 for myelosuppression. Sensitivity analysis and subgroup analysis were also performed. The 18 eligible randomized controlled trials demonstrated that the combination of WBRT and TMZ significantly improves the ORR and is statistically insignificant in prolonging the survival of patients with BMs. In addition, an increase in the incidence of gastrointestinal toxicity and myelosuppression was significant for all-grade.

  6. Community-Based Intervention to Improve Cardiometabolic Targets in Patients With Stroke: A Randomized Controlled Trial.

    PubMed

    Olaiya, Muideen T; Cadilhac, Dominique A; Kim, Joosup; Nelson, Mark R; Srikanth, Velandai K; Gerraty, Richard P; Bladin, Christopher F; Fitzgerald, Sharyn M; Phan, Thanh; Frayne, Judith; Thrift, Amanda G

    2017-09-01

    Many guidelines for secondary prevention of stroke focus on controlling cardiometabolic risk factors. We investigated the effectiveness of a management program for attaining cardiometabolic targets in survivors of stroke/transient ischemic attack. Randomized controlled trial of survivors of stroke/transient ischemic attack aged ≥18 years. General practices were randomized to usual care (control) or an intervention comprising specialist review of care plans and nurse education in addition to usual care. The outcome is attainment of pre-defined cardiometabolic targets based on Australian guidelines. Multivariable regression was undertaken to determine efficacy and identify factors associated with attaining targets. Overall, 283 subjects were randomized to the intervention and 280 to controls. Although we found no between-group difference in overall cardiometabolic targets achieved at 12 months, the intervention group more often achieved control of low-density lipoprotein cholesterol (odds ratio, 1.97; 95% confidence interval, 1.18-3.29) than controls. At 24 months, no between-group differences were observed. Medication adherence was ≥80% at follow-up, but uptake of lifestyle/behavioral habits was poor. Older age, being male, being married/living with partner, and having greater functional ability or a history of diabetes mellitus were associated with attaining targets. The intervention in this largely negative trial only had a detectable effect on attaining target for lipids but not for other factors at 12 months or any factor at 24 months. This limited effect may be attributable to inadequate uptake of behavioral/lifestyle interventions, highlighting the need for new or better approaches to achieve meaningful behavioral change. URL: http://www.clinicaltrials.gov. Unique identifier: ACTRN12608000166370. © 2017 American Heart Association, Inc.

  7. Efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (rTMS) versus electroconvulsive therapy (ECT) for major depression: a systematic review and meta-analysis of randomized trials.

    PubMed

    Berlim, Marcelo T; Van den Eynde, Frederique; Daskalakis, Zafiris J

    2013-07-01

    Clinical trials comparing the efficacy and acceptability of high frequency repetitive transcranial magnetic stimulation (HF-rTMS) and electroconvulsive therapy (ECT) for treating major depression (MD) have yielded conflicting results. As this may have been the result of limited statistical power, we have carried out this meta-analysis to examine this issue. We searched the literature for randomized trials on head-to-head comparisons between HF-rTMS and ECT from January 1995 through September 2012 using MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and SCOPUS. The main outcome measures were remission rates, pre-post changes in depression ratings, as well as overall dropout rates at study end. We used a random-effects model, Odds Ratios (OR), Number Needed to Treat (NNT), and Hedges' g effect sizes. Data were obtained from 7 randomized trials, totalling 294 subjects with MD. After an average of 15.2 HF-rTMS and 8.2 ECT sessions, 33.6% (38/113) and 52% (53/102) of subjects were classified as remitters (OR = 0.46; p = 0.04), respectively. The associated NNT for remission was 6 and favoured ECT. Also, reduction of depressive symptomatology was significantly more pronounced in the ECT group (Hedges' g = -0.93; p = 0.007). No differences on dropout rates for HF-rTMS and ECT groups were found. In conclusion, ECT seems to be more effective than HF-rTMS for treating MD, although they did not differ in terms of dropout rates. Nevertheless, future comparative trials with larger sample sizes and better matching at baseline, longer follow-ups and more intense stimulation protocols are warranted. © 2013 Wiley Periodicals, Inc.

  8. Green's-function theory of dirty two-band superconductivity

    NASA Astrophysics Data System (ADS)

    Asano, Yasuhiro; Golubov, Alexander A.

    2018-06-01

    We study the effects of random nonmagnetic impurities on the superconducting transition temperature Tc in a two-band superconductor, where we assume an equal-time spin-singlet s -wave pair potential in each conduction band and the hybridization between the two bands as well as the band asymmetry. In the clean limit, the phase of hybridization determines the stability of two states, called s++ and s+-. The interband impurity scatterings decrease Tc of the two states exactly in the same manner when time-reversal symmetry is preserved in the Hamiltonian. We find that a superconductor with larger hybridization shows more moderate suppression of Tc. This effect can be explained by the presence of odd-frequency Cooper pairs, which are generated by the band hybridization in the clean limit and are broken by impurities.

  9. Fear of childbirth in expectant fathers, subsequent childbirth experience and impact of antenatal education: subanalysis of results from a randomized controlled trial.

    PubMed

    Bergström, Malin; Rudman, Ann; Waldenström, Ulla; Kieler, Helle

    2013-08-01

    To explore if antenatal fear of childbirth in men affects their experience of the birth event and if this experience is associated with type of childbirth preparation. Data from a randomized controlled multicenter trial on antenatal education. 15 antenatal clinics in Sweden between January 2006 and May 2007. 762 men, of whom 83 (10.9%) suffered from fear of childbirth. Of these 83 men, 39 were randomized to psychoprophylaxis childbirth preparation where men were trained to coach their partners during labor and 44 to standard care antenatal preparation for childbirth and parenthood without such training. Experience of childbirth was compared between men with and without fear of childbirth regardless of randomization, and between fearful men in the randomized groups. Analyses by logistic regression adjusted for sociodemographic variables. Self-reported data on experience of childbirth including an adapted version of the Wijma Delivery Experience Questionnaire (W-DEQ B). Men with antenatal fear of childbirth more often experienced childbirth as frightening than men without fear: adjusted odds ratio 4.68, 95% confidence interval 2.67-8.20. Men with antenatal fear in the psychoprophylaxis group rated childbirth as frightening less often than those in standard care: adjusted odds ratio 0.30, 95% confidence interval 0.10-0.95. Men who suffer from antenatal fear of childbirth are at higher risk of experiencing childbirth as frightening. Childbirth preparation including training as a coach may help fearful men to a more positive childbirth experience. Additional studies are needed to support this conclusion. © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

  10. Systematization of α-decaying nuclei based on shell structures: The case of odd-even and odd-odd nuclei

    NASA Astrophysics Data System (ADS)

    Yarman, Tolga; Zaim, Nimet; Yarman, Ozan; Kholmetskii, Alexander; Arık, Metin

    In previous studies, we provided a novel systematization of α-decaying even-even and even-odd nuclei starting with the classically adopted mechanism [T. Yarman et al., Eur. Phys. J. A 52 (2016) 140; Eur. Phys. J. A 53 (2017) 4]. Knowing beforehand the measured decay half-life, we had taken as a parameter the probability of the α-particle as being first born in a unit period of time, within the parent nucleus before it is emitted out. We thence developed a scaffold based on shell properties of families composed of “alike nuclei”. Along the same line, we now present a systematization of odd-even (OE) as well as odd-odd (OO) nuclei. We apply our approach further to the investigation of the effect of pairing (e.g., the effect when the number of nucleons is increased by one neutron), and that of unpairing (e.g., the effect when the number of nucleons is decreased by one neutron); thus it becomes an even number for the case of odd-even nuclei (Case OE), and an odd number in the case of odd-odd nuclei (Case OO). For the first case (OE), we pick the exemplar set 161Re, 217Fr, 243Bk, 263Db; where we delineate by, respectively, Re, Fr, Bk, and Db all of the odd-even or odd-odd isotopes that neighbor the four mentioned odd-even isotopes on the proposed scaffold. We proceed in the same way for the second case (OO). Thus, we choose the exemplar set of odd-odd nuclei 172Ir, 218Ac, 244Es. We then gather all of the Ir, Ac, and Es odd-odd and odd-even isotopes that neighbor the three mentioned odd-odd isotopes on the proposed scaffold. We show that, in the former case, pairing, as expected, generally increases stability of the given nucleus; and in the latter case, unpairing works in just the opposite direction — i.e., it generally increases instability. We disclose “stability peaks” versus Z for both sets of nuclei, we tackle here. Furthermore, we present a study to highlight an outlook of “odd-A nuclei” at hand. Contrary to the general expectation, we unveil no systematic on that.

  11. Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

    PubMed Central

    Indahl, Aage; Andersen, Lars L.; Burton, Kim; Hertzum-Larsen, Rasmus

    2017-01-01

    Background Low back pain (LBP) is common in the population and multifactorial in nature, often involving negative consequences. Reassuring information to improve coping is recommended for reducing the negative consequences of LBP. Adding a simple non-threatening explanation for the pain (temporary muscular dysfunction) has been successful at altering beliefs and behavior when delivered with other intervention elements. This study investigates the isolated effect of this specific information on future occupational behavior outcomes when delivered to the workforce. Design A cluster-randomized controlled trial. Methods Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non-threatening explanation for LBP—the ‘functional-disturbance’-model. Data collections took place monthly over a 1-year period using text message tracking (SMS). Primary outcomes were self-reported days of cutting down usual activities and work participation. Secondary outcomes were self-reported back beliefs, work ability, number of healthcare visits, bothersomeness, restricted activity, use of pain medication, and sadness/depression. Results There was no between-group difference in the development of LBP during follow-up. Cumulative logistic regression analyses showed no between-group difference on days of cutting down activities, but increased odds for more days of work participation in the intervention group (OR = 1.83 95% CI: 1.08–3.12). Furthermore, the intervention group was more likely to report: higher work ability, reduced visits to healthcare professionals, lower bothersomeness, lower levels of sadness/depression, and positive back beliefs. Conclusion Reassuring information involving a simple non-threatening explanation for LBP significantly increased the odds for days of work participation and higher work ability among workers who went on to experience LBP during the 12-month follow-up. Our results confirm the potential for public-health education for LBP, and add to the discussion of simple versus multidisciplinary interventions. PMID:28346472

  12. Computed Tomographic Perfusion Predicts Poor Outcomes in a Randomized Trial of Endovascular Therapy.

    PubMed

    Wannamaker, Robert; Guinand, Taurian; Menon, Bijoy K; Demchuk, Andrew; Goyal, Mayank; Frei, Donald; Bharatha, Aditya; Jovin, Tudor G; Shankar, Jai; Krings, Timo; Baxter, Blaise; Holmstedt, Christine; Swartz, Richard; Dowlatshahi, Dar; Chan, Richard; Tampieri, Donatella; Choe, Hana; Burns, Paul; Gentile, Nina; Rempel, Jeremy; Shuaib, Ashfaq; Buck, Brian; Bivard, Andrew; Hill, Michael; Butcher, Kenneth

    2018-06-01

    In the ESCAPE trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times), patients with large vessel occlusions and small infarct cores identified with computed tomography (CT)/CT angiography were randomized to endovascular therapy or standard of care. CT perfusion (CTP) was obtained in some cases but was not used to select patients. We tested the hypothesis that patients with penumbral CTP patterns have higher rates of good clinical outcome. All CTP data acquired in ESCAPE patients were analyzed centrally using a semiautomated perfusion threshold-based approach. A penumbral pattern was defined as an infarct core <70 mL, penumbral volume >15 mL, and a total hypoperfused volume:core volume ratio of >1.8. The primary outcome was good functional outcome at 90 days (modified Rankin Scale score, 0-2). CTP was acquired in 138 of 316 ESCAPE patients. Penumbral patterns were present in 116 of 128 (90.6%) of patients with interpretable CTP data. The rate of good functional outcome in penumbral pattern patients (53 of 114; 46%) was higher than that in nonpenumbral patients (2 of 12; 17%; P =0.041). In penumbral patients, endovascular therapy increased the likelihood of a good clinical outcome (34 of 58; 57%) compared with those in the control group (19 of 58; 33%; odds ratio, 2.68; 95% confidence interval, 1.25-5.76; P =0.011). Only 3 of 12 nonpenumbral patients were randomized to the endovascular group, preventing an analysis of treatment effect. The majority of patients with CTP imaging in the ESCAPE trial had penumbral patterns, which were associated with better outcomes overall. Patients with penumbra treated with endovascular therapy had the greatest odds of good functional outcome. Nonpenumbral patients were much less likely to achieve good outcomes. © 2018 American Heart Association, Inc.

  13. Short-Term High-Dose Vitamin E to Prevent Contrast Medium-Induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Elective Coronary Angiography: A Randomized Placebo-Controlled Trial.

    PubMed

    Rezaei, Yousef; Khademvatani, Kamal; Rahimi, Behzad; Khoshfetrat, Mehran; Arjmand, Nasim; Seyyed-Mohammadzad, Mir-Hossein

    2016-03-15

    Contrast medium-induced acute kidney injury (CIAKI) is a leading cause of acquired renal impairment. The effects of antioxidants have been conflicting regarding the prevention of CIAKI. We performed a study of vitamin E use to decrease CIAKI in patients undergoing elective coronary angiography. In a placebo-controlled randomized trial at 2 centers in Iran, 300 patients with chronic kidney disease-defined as estimated glomerular filtration rate <60 mL/min per 1.73 m(2)-were randomized 1:1 to receive 0.9% saline infusion 12 hours prior to and after intervention combined with 600 mg vitamin E 12 hours before plus 400 mg vitamin E 2 hours before coronary angiography or to receive placebo. The primary end point was the development of CIAKI, defined as an increase ≥0.5 mg/dL or ≥25% in serum creatinine that peaked within 72 hours. Based on an intention-to-treat analysis, CIAKI developed in 10 (6.7%) and 21 (14.1%) patients in the vitamin E and placebo groups, respectively (P=0.037). Change in white blood cell count from baseline to peak value was greater in the vitamin E group compared with the placebo group (-500 [-1500 to 200] versus 100 [-900 to 600]×10(3)/mL, P=0.001). In multivariate analysis, vitamin E (odds ratio 0.408, 95% CI 0.170-0.982, P=0.045) and baseline Mehran score (odds ratio 1.257, 95% CI 1.007-1.569; P=0.043) predicted CIAKI. Prophylactic short-term high-dose vitamin E combined with 0.9% saline infusion is superior to placebo for prevention of CIAKI in patients undergoing elective coronary angiography. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02070679. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  14. The Role of Prostatitis in Prostate Cancer: Meta-Analysis

    PubMed Central

    Yunxia, Zhang; Zhu, Hong; Liu, Junjiang; Pumill, Chris

    2013-01-01

    Objective Use systematic review methods to quantify the association between prostatitis and prostate cancer, under both fixed and random effects model. Evidence Acquisition Case control studies of prostate cancer with information on prostatitis history. All studies published between 1990-2012, were collected to calculate a pooled odds ratio. Selection criteria: the selection criteria are as follows: human case control studies; published from May 1990 to July 2012; containing number of prostatitis, and prostate cancer cases. Evidence Synthesis In total, 20 case control studies were included. A significant association between prostatitis and prostate cancer was found, under both fixed effect model (pooled OR=1.50, 95%CI: 1.39-1.62), and random effects model (OR=1.64, 95%CI: 1.36-1.98). Personal interview based case control studies showed a high level of association (fixed effect model: pooled OR=1.59, 95%CI: 1.47-1.73, random effects model: pooled OR= 1.87, 95%CI: 1.52-2.29), compared with clinical based studies (fixed effect model: pooled OR=1.05, 95%CI: 0.86-1.28, random effects model: pooled OR= 0.98, 95%CI: 0.67-1.45). Additionally, pooled ORs, were calculated for each decade. In a fixed effect model: 1990’s: OR=1.58, 95% CI: 1.35-1.84; 2000’s: OR=1.59, 95% CI: 1.40-1.79; 2010’s: OR=1.37, 95% CI: 1.22-1.56. In a random effects model: 1990’s: OR=1.98, 95% CI: 1.08-3.62; 2000’s: OR=1.64, 95% CI: 1.23-2.19; 2010’s: OR=1.34, 95% CI: 1.03-1.73. Finally a meta-analysis stratified by each country was conducted. In fixed effect models, U.S: pooled OR =1.45, 95%CI: 1.34-1.57; China: pooled OR =4.67, 95%CI: 3.08-7.07; Cuba: pooled OR =1.43, 95%CI: 1.00-2.04; Italy: pooled OR =0.61, 95%CI: 0.13-2.90. In random effects model, U.S: pooled OR=1.50, 95%CI: 1.25-1.80; China: pooled OR =4.67, 95%CI: 3.08-7.07; Cuba: pooled OR =1.43, 95%CI: 1.00-2.04; Italy: pooled OR =0.61, 95%CI: 0.13-2.90.CONCLUSIONS: the present meta-analysis provides the statistical evidence that the association between prostatitis and prostate cancer is significant. PMID:24391995

  15. Association of nurse work environment and safety climate on patient mortality: A cross-sectional study.

    PubMed

    Olds, Danielle M; Aiken, Linda H; Cimiotti, Jeannie P; Lake, Eileen T

    2017-09-01

    There are two largely distinct research literatures on the association of the nurse work environment and the safety climate on patient outcomes. To determine whether hospital safety climate and work environment make comparable or distinct contributions to patient mortality. Cross-sectional secondary analysis of linked datasets of Registered Nurse survey responses, adult acute care discharge records, and hospital characteristics. Acute care hospitals in California, Florida, New Jersey, and Pennsylvania. The sample included 600 hospitals linked to 27,009 nurse survey respondents and 852,974 surgical patients. Nurse survey data included assessments of the nurse work environment and hospital safety climate. The outcome of interest was in-hospital mortality. Data analyses included descriptive statistics and multivariate random intercept logistic regression. In a fully adjusted model, a one standard deviation increase in work environment score was associated with an 8.1% decrease in the odds of mortality (OR 0.919, p<0.001). A one-standard deviation increase in safety climate score was similarly associated with a 7.7% decrease in the odds of mortality (OR 0.923, p<0.001). However, when work environment and safety climate were modeled together, the effect of the work environment remained significant, while safety climate became a non-significant predictor of mortality odds (OR 0.940, p=0.035 vs. OR 0.971, p=0.316). We found that safety climate perception is not predictive of patient mortality beyond the effect of the nurse work environment. To advance hospital safety and quality and improve patient outcomes, organizational interventions should be directed toward improving nurse work environments. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. The Impact of the Teen Outreach Program on Sexual Intentions and Behaviors.

    PubMed

    Walsh-Buhi, Eric R; Marhefka, Stephanie L; Wang, Wei; Debate, Rita; Perrin, Kay; Singleton, Ashley; Noble, Charlotte A; Rahman, Saba; Maness, Sarah B; Mahony, Helen; Ziemba, Robert; Malmi, Markku; Marwah, Elizabeth; Hall, Kristin; Turner, DeAnne; Blunt-Vinti, Heather; Noble, Shireen M; Daley, Ellen M

    2016-09-01

    We evaluated the impact of a positive youth development program on adolescent pregnancy, sexual behavior, risky sex, and intentions in nonmetropolitan Florida high schools. Between 2012 and 2014, the Teen Outreach Program (TOP) was compared to standard school curriculum content using a cluster randomized controlled trial design with 7,976 youth in two cohorts. The majority of youth were 14 years old and in the ninth grade at baseline. Treatment group youth received TOP in health-related classes. After using multiple imputation to account for missing data, we analyzed baseline and follow-up survey data using generalized linear mixed-effects models with logit link function. In the cohort 1 sample, compared to the control condition, males and females receiving TOP showed lower odds of engaging in recent sex (odds ratio [OR], .71; 95% confidence interval [CI]: .58-.86) compared to control males and females. Cohort 1 treatment females who did engage in recent sex were less likely to have risky sex (OR, .54; 95% CI: .32-.89). There were fewer significant findings in cohort 2, though TOP females and combined gender had lower odds of risky sex intentions (OR, .53; 95% CI: .33-.84 and OR, .65; 95% CI: .44-.96, respectively). Overall, cohort 1 females in the TOP condition were the group most likely to benefit from TOP. Consistent with previous research, TOP was more effective regarding sexual health outcomes among female versus male youth; this was especially true for the outcome of risky sex. However, results were not consistent across cohorts, prompting questions for future research. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  17. What Happens After Treatment? Long-Term Effects of Continued Substance Use, Psychiatric Problems and Help-Seeking on Social Status of Alcohol-Dependent Individuals.

    PubMed

    Karriker-Jaffe, Katherine J; Witbrodt, Jane; Subbaraman, Meenakshi S; Kaskutas, Lee Ann

    2018-03-30

    We examined whether alcohol-dependent individuals with sustained substance use or psychiatric problems after completing treatment were more likely to experience low social status and whether continued help-seeking would improve outcomes. Ongoing alcohol, drug and psychiatric problems after completing treatment were associated with increased odds of low social status (unemployment, unstable housing and/or living in high-poverty neighborhood) over 7 years. The impact of drug problems declined over time, and there were small, delayed benefits of AA attendance on social status. Alcohol-dependent individuals sampled from public and private treatment programs (N = 491; 62% male) in Northern California were interviewed at treatment entry and 1, 3, 5 and 7 years later. Random effects models tested relationships between problem severity (alcohol, drug and psychiatric problems) and help-seeking (attending specialty alcohol/drug treatment and Alcoholics Anonymous, AA) with low social status (unemployment, unstable housing and/or living in a high-poverty neighborhood) over time. The proportion of participants experiencing none of the indicators of low social status increased between baseline and the 1-year follow-up and remained stable thereafter. Higher alcohol problem scores and having any drug and/or psychiatric problems in the years after treatment were associated with increased odds of low social status over time. An interaction of drug problems with time indicated the impact of drug problems on social status declined over the 7-year period. Both treatment-seeking and AA attendance were associated with increased odds of low social status, although lagged models suggested there were small, delayed benefits of AA attendance on improved social status over time. Specialty addiction treatment alone was not sufficient to have positive long-term impacts on social status and social integration of most alcohol-dependent people.

  18. Statin use is associated with reduced risk of histologic subtypes of esophageal cancer: a nested case-control analysis.

    PubMed

    Alexandre, Leo; Clark, Allan B; Bhutta, Hina Y; Holt, Sean; Lewis, Michael P N; Hart, Andrew R

    2014-03-01

    Most patients with esophageal adenocarcinoma (EAC) or squamous cell cancer (ESCC) present with advanced, incurable disease. Statins have reported anti-carcinogenic effects and may be chemoprotective. We investigated the association between regular use of statins and the main histologic subtypes of esophageal malignancy (EAC, esophagogastric junctional adenocarcinoma, and ESCC) in the UK general population. We identified all individuals in the UK General Practice Research Database diagnosed with esophageal cancer from 2000 through 2009. Patients were linked to the National Cancer Registry to confirm histologic subtypes. Each patient was matched with up to 4 controls for age, sex, and practice. We performed a nested case-control analysis using conditional logistic regression to estimate the risk of each subtype with regular statin use, adjusted for body mass index, smoking, alcohol intake, and concomitant use of medications. In total, 581 participants with EAC, 213 with esophagogastric junctional adenocarcinoma, and 332 with ESCC were matched to 2167, 783, and 1242 controls, respectively. Regular statin use was inversely associated with development of EAC (odds ratio = 0.58; 95% confidence interval: 0.39-0.87) (with significant dose and duration responses) and esophagogastric junctional adenocarcinoma (odds ratio = 0.29; 95% confidence interval: 0.09-0.92) (with high-dose use only). Statin use for 1-4 years was inversely associated with ESCC (odds ratio = 0.51; 95% confidence interval: 0.27-0.98). In a nested case-control analysis of a UK population-based cohort, statin use was inversely associated with histologic subtypes of esophageal cancer. Randomized controlled trials are warranted to determine whether statins have chemopreventive effects in high-risk groups. Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.

  19. NSAIDs and colorectal cancer risk: do administrative data support a chemopreventive effect?

    PubMed

    Lamont, Elizabeth B; Dias, Lauren E; Lauderdale, Diane S

    2007-08-01

    Randomized trials show non-steroidal anti-inflammatory drugs (NSAIDs) reduce precancerous polyps. Observational studies of the NSAID aspirin (ASA) suggest that it reduces invasive colorectal cancer (CRC) incidence, but because ASA use may also be a marker for healthy behaviors, these studies may be subject to selection bias. We sought to estimate the effectiveness of NSAIDs in CRC prevention in the population of elderly Medicare beneficiaries, minimizing this selection bias. With National Ambulatory Medical Care Survey data, we find that patients with a diagnosis of osteoarthritis (OA) are 4.4 times more likely to concurrently have NSAID use documented than patients without such a diagnosis. We use this figure to estimate the expected NSAID-mediated reduction in CRC risk associated with a diagnosis of OA. Using Survival Epidemiology and End-Results (SEER)-Medicare data, we compare cases of elderly Medicare beneficiaries diagnosed with CRC in 1995 to persons without CRC to determine if their odds of antecedent OA differ. We estimate the expected NSAID-mediated reduction in CRC associated with an OA diagnosis to be between 6 and 16% (i.e., RR, 0.84-0.94). In the SEER-Medicare data, we find that individuals with a diagnosis of OA in Medicare claims in the previous 3 years had 15% lower odds of being diagnosed with CRC than individuals whose claims did not reflect antecedent OA (OR 0.85, 95%CI 0.80-0.91). This case-control study finds that elderly Medicare beneficiaries with histories of OA have 15% lower odds of developing CRC. These results are consistent with a preventive role for NSAIDs in CRC among the elderly.

  20. Olive oil intake is inversely related to cancer prevalence: a systematic review and a meta-analysis of 13800 patients and 23340 controls in 19 observational studies

    PubMed Central

    2011-01-01

    Dietary fat, both in terms of quantity and quality, has been implicated to cancer development, either positively or negatively. The aim of this work was to evaluate whether olive oil or monounsaturated fat intake was associated with the development of cancer. A systematic search of relevant studies, published in English, between 1990 and March 1, 2011, was performed through a computer-assisted literature tool (i.e., Pubmed). In total 38 studies were initially allocated; of them 19 case-control studies were finally studied (13800 cancer patients and 23340 controls were included). Random effects meta-analysis was applied in order to evaluate the research hypothesis. It was found that compared with the lowest, the highest category of olive oil consumption was associated with lower odds of having any type of cancer (log odds ratio = -0.41, 95%CI -0.53, -0.29, Cohran's Q = 47.52, p = 0.0002, I-sq = 62%); the latter was irrespective of the country of origin (Mediterranean or non-Mediterranean). Moreover, olive oil consumption was associated with lower odds of developing breast cancer (logOR = -0,45 95%CI -0.78 to -0.12), and a cancer of the digestive system (logOR = -0,36 95%CI -0.50 to -0.21), compared with the lowest intake. The strength and consistency of the findings states a hypothesis about the protective role of olive oil intake on cancer risk. However, it is still unclear whether olive oil's monounsaturated fatty acid content or its antioxidant components are responsible for its beneficial effects. PMID:21801436

  1. The Effect of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) on Erectile Function: A Systematic Review and Meta-Analysis.

    PubMed

    Chen, Xiang; Zhou, ZhiRui; Qiu, XiaoChun; Wang, Bin; Dai, JiCan

    2015-01-01

    High prevalence of erectile dysfunction (ED) has been observed in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). However, whether or not CP/CPPS is a risk factor of ED remains unknown and controversial. Therefore, we conducted this systematic review and meta-analysis to evaluate the relationship between CP/CPPS and ED. PubMed, Embase, Web of Science, and The Cochrane Library were searched up to November 11, 2014 to identify studies reporting the association between CP/CPPS and ED. Case-control, cohort and cross-sectional studies were included. Quality of the included studies was assessed. The odds ratio of ED and the mean difference of five-item International Index of Erectile Function (IIEF-5) score were pooled using a random effects model. Subgroup analysis and sensitivity analyses were performed. Three cross-sectional studies, two case-control studies, and four retrospective studies with 31,956 participants were included to calculate the pooled odds ratio of ED, and two studies with 1499 participants were included to calculate the pooled mean difference of IIEF-5 scores. A strong correlation was found between CP/CPPS and ED (pooled odds ratio: 3.02, 95% CI: 2.18-4.17, P < 0.01), with heterogeneity across studies (I2 = 65%; P < 0.01). A significant decrease in the IIFE-5 score was observed in the CP/CPPS group (pooled mean difference: -4.54, 95% CI: -5.11--3.98; P < 0.01). Our study indicates that patients with CP/CPPS have an increased risk of suffering from ED. Assessment of erectile function is necessary for the therapy of patients with CP/CPPS. Further evidence is necessary to confirm the relationship between CP/CPPS and ED.

  2. Risk of placenta previa in second birth after first birth cesarean section: a population-based study and meta-analysis

    PubMed Central

    2011-01-01

    Background Objective: To compare the risk of placenta previa at second birth among women who had a cesarean section (CS) at first birth with women who delivered vaginally. Methods Retrospective cohort study of 399,674 women who gave birth to a singleton first and second baby between April 2000 and February 2009 in England. Multiple logistic regression was used to adjust the estimates for maternal age, ethnicity, deprivation, placenta previa at first birth, inter-birth interval and pregnancy complications. In addition, we conducted a meta-analysis of the reported results in peer-reviewed articles since 1980. Results The rate of placenta previa at second birth for women with vaginal first births was 4.4 per 1000 births, compared to 8.7 per 1000 births for women with CS at first birth. After adjustment, CS at first birth remained associated with an increased risk of placenta previa (odds ratio = 1.60; 95% CI 1.44 to 1.76). In the meta-analysis of 37 previously published studies from 21 countries, the overall pooled random effects odds ratio was 2.20 (95% CI 1.96-2.46). Our results from the current study is consistent with those of the meta-analysis as the pooled odds ratio for the six population-based cohort studies that analyzed second births only was 1.51 (95% CI 1.39-1.65). Conclusions There is an increased risk of placenta previa in the subsequent pregnancy after CS delivery at first birth, but the risk is lower than previously estimated. Given the placenta previa rate in England and the adjusted effect of previous CS, 359 deliveries by CS at first birth would result in one additional case of placenta previa in the next pregnancy. PMID:22103697

  3. Association Between ADHD and Obesity: A Systematic Review and Meta-Analysis.

    PubMed

    Cortese, Samuele; Moreira-Maia, Carlos Renato; St Fleur, Diane; Morcillo-Peñalver, Carmen; Rohde, Luis Augusto; Faraone, Stephen V

    2016-01-01

    Impulsivity and inattention related to attention deficit hyperactivity disorder (ADHD) may increase food intake and, consequently, weight gain. However, findings on the association between obesity/overweight and ADHD are mixed. The authors conducted a meta-analysis to estimate this association. A broad range of databases was searched through Aug. 31, 2014. Unpublished studies were also obtained. Study quality was rated with the Newcastle-Ottawa Scale. Random-effects models were used. Forty-two studies that included a total of 728,136 individuals (48,161 ADHD subjects; 679,975 comparison subjects) were retained. A significant association between obesity and ADHD was found for both children (odds ratio=1.20, 95% CI=1.05-1.37) and adults (odds ratio=1.55, 95% CI=1.32-1.81). The pooled prevalence of obesity was increased by about 70% in adults with ADHD (28.2%, 95% CI=22.8-34.4) compared with those without ADHD (16.4%, 95% CI=13.4-19.9), and by about 40% in children with ADHD (10.3%, 95% CI=7.9-13.3) compared with those without ADHD (7.4%, 95% CI=5.4-10.1). The significant association between ADHD and obesity remained when limited to studies 1) reporting odds ratios adjusted for possible confounding factors; 2) diagnosing ADHD by direct interview; and 3) using directly measured height and weight. Gender, study setting, study country, and study quality did not moderate the association between obesity and ADHD. ADHD was also significantly associated with overweight. Individuals medicated for ADHD were not at higher risk of obesity. This study provides meta-analytic evidence for a significant association between ADHD and obesity/overweight. Further research should address possible underlying mechanisms and the long-term effects of ADHD treatments on weight in individuals with both ADHD and obesity.

  4. Cesarean Outcomes in US Birth Centers and Collaborating Hospitals: A Cohort Comparison.

    PubMed

    Thornton, Patrick; McFarlin, Barbara L; Park, Chang; Rankin, Kristin; Schorn, Mavis; Finnegan, Lorna; Stapleton, Susan

    2017-01-01

    High rates of cesarean birth are a significant health care quality issue, and birth centers have shown potential to reduce rates of cesarean birth. Measuring this potential is complicated by lack of randomized trials and limited observational comparisons. Cesarean rates vary by provider type, setting, and clinical and nonclinical characteristics of women, but our understanding of these dynamics is incomplete. We sought to isolate labor setting from other risk factors in order to assess the effect of birth centers on the odds of cesarean birth. We generated low-risk cohorts admitted in labor to hospitals (n = 2527) and birth centers (n = 8776) using secondary data obtained from the American Association of Birth Centers (AABC). All women received prenatal care in the birth center and midwifery care in labor, but some chose hospital admission for labor. Analysis was intent to treat according to site of admission in spontaneous labor. We used propensity score adjustment and multivariable logistic regression to control for cohort differences and measured effect sizes associated with setting. There was a 37% (adjusted odds ratio [OR], 0.63; 95% confidence interval [CI], 0.50-0.79) to 38% (adjusted OR, 0.62; 95% CI, 0.49-0.79) decreased odds of cesarean in the birth center cohort and a remarkably low overall cesarean rate of less than 5% in both cohorts. These findings suggest that low rates of cesarean in birth centers are not attributable to labor setting alone. The entire birth center care model, including prenatal preparation and relationship-based midwifery care, should be studied, promoted, and implemented by policy makers interested in achieving appropriate cesarean rates in the United States. © 2016 by the American College of Nurse-Midwives.

  5. The Effect of Ultralow-Dose Transdermal Estradiol on Urinary Incontinence in Postmenopausal Women

    PubMed Central

    Waetjen, L. Elaine; Brown, Jeanette S.; Vittinghoff, Eric; Ensrud, Kristine E.; Pinkerton, JoAnn; Wallace, Robert; Macer, Judith L.; Grady, Deborah

    2006-01-01

    OBJECTIVE To estimate the effect of 2 years of treatment with ultralow-dose transdermal estradiol (E2) on incontinence in postmenopausal women. METHODS Ultra Low Dose Transdermal estRogen Assessment (ULTRA) was a multicenter, randomized, double-blinded, placebo-controlled trial of unopposed ultralow-dose (0.014 mg/d) transdermal E2 for prevention of osteoporosis in 417 postmenopausal women aged 60 to 80 years. Frequency of incontinence episodes was assessed at baseline and after 4 months and 2 years of treatment using a self-reported questionnaire. We used an intention-to-treat analysis to compare change in incontinence frequency, improved (decreased 2 or more episodes per week), unchanged (increased or decreased no more than 1 episode per week), or worsened (increased 2 or more episodes per week) between the E2 and placebo groups among women with and without at least weekly incontinence at baseline. RESULTS At baseline, the prevalence of at least weekly incontinence was similar between E2 and placebo groups (43%). After 2 years, there was no difference between groups in the proportions of women with incontinence at baseline whose incontinence improved, worsened, or was unchanged. The odds ratio for worsening incontinence in the E2 compared with placebo group was 1.35 (95% confidence interval 0.75–2.42. In women without incontinence at baseline, the odds of developing at least weekly incontinence after 2 years in the E2 compared with placebo group was not significant (odds ratio 1.2, 95% confidence interval 0.7–2.2). CONCLUSION Two years of treatment with unopposed ultralow-dose transdermal E2 did not substantially change the frequency of incontinence symptoms or alter the risk of developing at least weekly incontinence. PMID:16260511

  6. Effects of lipid-based nutrient supplements v. micronutrient powders on nutritional and developmental outcomes among Peruvian infants.

    PubMed

    Matias, Susana L; Vargas-Vásquez, Alejandro; Bado Pérez, Ricardo; Alcázar Valdivia, Lorena; Aquino Vivanco, Oscar; Rodriguez Martín, Amelia; Novalbos Ruiz, Jose Pedro

    2017-11-01

    To determine the effects of lipid-based nutrient supplements (LNS) on children's Hb, linear growth and development, compared with supplementation with micronutrient powder (MNP). The study was a two-arm parallel-group randomized controlled trial, where participants received either LNS or MNP for daily consumption during 6 months. Supplements were delivered by staff at government-run health centres. Hb, anthropometric, motor development, language development and problem-solving indicators were measured by trained research assistants when children were 12 months of age. The study was conducted in five rural districts in the Province of Ambo in the Department of Huánuco, Peru. We enrolled 6-month-old children (n 422) at nineteen health centres. Children who received LNS had a higher mean Hb concentration and lower odds of anaemia than those who received MNP. No significant differences in height-for-age, weight-for-height or weight-for-age Z-score, or stunting and underweight prevalence, were observed. Provision of LNS was associated with a higher pre-verbal language (gestures) score, but such effect lost significance after adjustment for covariates. Children in the LNS group had higher problem-solving task scores and increased odds of achieving this cognitive task than children in the MNP group. No significant differences were observed on receptive language or gross motor development. LNS between 6 and 12 months of age increased Hb concentration, reduced anaemia and improved cognitive development in children, but showed no effects on anthropometric indicators, motor or language development.

  7. Effects of different impact exercise modalities on bone mineral density in premenopausal women: a meta-analysis.

    PubMed

    Martyn-St James, Marrissa; Carroll, Sean

    2010-05-01

    Our objective was to assess the effects of differing modes of impact exercise on bone density at the hip and spine in premenopausal women through systematic review and meta-analysis. Electronic databases, key journals and reference lists were searched for controlled trials investigating the effects of impact exercise interventions on lumbar spine (LS), femoral neck (FN) and total hip (TH) bone mineral density (BMD) in premenopausal women. Exercise protocols were categorised according to impact loading characteristics. Weighted mean difference (WMD) meta-analyses were undertaken. Heterogeneity amongst trials was assessed. Fixed and random effects models were applied. Inspection of funnel plot symmetry was performed. Trial quality assessment was also undertaken. Combined protocols integrating odd- or high-impact exercise with high-magnitude loading (resistance exercises), were effective in increasing BMD at both LS and FN [WMD (fixed effect) 0.009 g cm(-2) 95% CI (0.002-0.015) and 0.007 g cm(-2) 95% CI (0.001-0.013); P = 0.011 and 0.017, respectively]. High-impact only protocols were effective on femoral neck BMD [WMD (fixed effect) 0.024 g cm(-2) 95% CI (0.002-0.027); P < 0.00001]. Funnel plots showed some asymmetry for positive BMD outcomes. Insufficient numbers of protocols assessing TH BMD were available for assessment. Exercise programmes that combine odd- or high-impact activity with high-magnitude resistance training appear effective in augmenting BMD in premenopausal women at the hip and spine. High-impact-alone protocols are effective only on hip BMD in this group. However, diverse methodological and reporting discrepancies are evident in published trials.

  8. The impact of two workplace-based health risk appraisal interventions on employee lifestyle parameters, mental health and work ability: results of a randomized controlled trial.

    PubMed

    Addley, K; Boyd, S; Kerr, R; McQuillan, P; Houdmont, J; McCrory, M

    2014-04-01

    Health risk appraisals (HRA) are a common type of workplace health promotion programme offered by American employers. In the United Kingdom, evidence of their effectiveness for promoting health behaviour change remains inconclusive. This randomized controlled trial examined the effects of two HRA interventions on lifestyle parameters, mental health and work ability in a UK context. A total of 180 employees were randomized into one of three groups: Group A (HRA augmented with health promotion and education activities), Group B (HRA only) and Group C (control, no intervention). After 12 months, changes in mean scoring in 10 lifestyle, mental health and work ability indices were compared, Groups A and B demonstrated non-significant improvements in 70% and 80%, respectively, compared with controls (40%). Odds ratios revealed that, compared with the control group, Group A was 29.2 (95% CI: 9.22-92.27) times more likely to report a perceived change in lifestyle behaviour; Group B 4.4 times (95% CI: 1.65-11.44). In conclusion, participation in the HRA was associated with a higher likelihood of perceived lifestyle behaviour change which was further increased in the augmented HRA group, thereby providing preliminary evidence that HRA and augmented HRA in particular may help UK employees make positive healthy lifestyle changes.

  9. Sample size estimation for alternating logistic regressions analysis of multilevel randomized community trials of under-age drinking.

    PubMed

    Reboussin, Beth A; Preisser, John S; Song, Eun-Young; Wolfson, Mark

    2012-07-01

    Under-age drinking is an enormous public health issue in the USA. Evidence that community level structures may impact on under-age drinking has led to a proliferation of efforts to change the environment surrounding the use of alcohol. Although the focus of these efforts is to reduce drinking by individual youths, environmental interventions are typically implemented at the community level with entire communities randomized to the same intervention condition. A distinct feature of these trials is the tendency of the behaviours of individuals residing in the same community to be more alike than that of others residing in different communities, which is herein called 'clustering'. Statistical analyses and sample size calculations must account for this clustering to avoid type I errors and to ensure an appropriately powered trial. Clustering itself may also be of scientific interest. We consider the alternating logistic regressions procedure within the population-averaged modelling framework to estimate the effect of a law enforcement intervention on the prevalence of under-age drinking behaviours while modelling the clustering at multiple levels, e.g. within communities and within neighbourhoods nested within communities, by using pairwise odds ratios. We then derive sample size formulae for estimating intervention effects when planning a post-test-only or repeated cross-sectional community-randomized trial using the alternating logistic regressions procedure.

  10. Meta-Analysis of the Effect of Chest Shielding on Preventing Patent Ductus Arteriosus in Premature Infants.

    PubMed

    Mannan, Javed; Amin, Sanjiv B

    2017-03-01

    Objective  This study aims to perform a meta-analysis of randomized studies to evaluate if chest shielding during phototherapy is associated with decreased incidence of patent ductus arteriosus (PDA) in premature infants. Design/Methods  We used published guidelines for the meta-analysis of clinical trials. The search strategy included electronic searches of CINAHL, CENTRAL Cochrane Library, MEDLINE, PubMed, and abstracts presented at the Pediatric Academic Societies. Inclusion criteria were randomized controlled trials (RCTs), quasi-RCTs or cluster RCTs published in English and involving chest shielding during phototherapy in premature infants with PDA as an outcome. Exclusion criteria involved case reports, case series, and multiple publications from the same author. Heterogeneity testing using Q statistics was performed to evaluate the variance between studies. Results  Two RCTs met study criteria. There was heterogeneity (I 2 : 55.4%) between the two trials. Meta-analysis of RCTs using the random effect model demonstrated that chest shielding during phototherapy was associated with decreased incidence of PDA (odds ratio: 0.47, 95% confidence interval: 0.23-0.96). There was no publication bias on Eggers test. Heterogeneity was seen in gestational age, gender, prophylactic use of postnatal indomethacin, duration of phototherapy, and assessment of PDA. Conclusion  Chest shielding during phototherapy may be associated with decreased incidence of PDA among premature infants. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  11. Rifaximin vs conventional oral therapy for hepatic encephalopathy: A meta-analysis

    PubMed Central

    Eltawil, Karim M; Laryea, Marie; Peltekian, Kevork; Molinari, Michele

    2012-01-01

    AIM: To characterize the efficacy of rifaximin in the management of hepatic encephalopathy (HE) as several randomized controlled studies have shown contradictory results on its effectiveness in comparison to other oral agents. METHODS: We performed a systematic review and random effects meta-analysis of all eligible trials identified through electronic and manual searches. Twelve randomized controlled trials met the inclusion criteria with a total of 565 patients. RESULTS: The clinical effectiveness of rifaximin was equivalent to disaccharides or other oral antibiotics [odds ratio (OR) 0.96; 95% CI: 0.94-4.08] but with a better safety profile (OR 0.27; 95% CI: 0.12-0.59). At the completion of treatment protocols, patients receiving rifaximin showed lower serum ammonia levels [weighted mean difference (WMD) = -10.65; 95% CI: -23.4-2.1; P = 0.10], better mental status (WMD = -0.24; 95% CI: -0.57-0.08; P = 0.15) and less asterixis (WMD -0.1; 95% CI -0.26-0.07; P = 0.25) without reaching statistical significance. On the other hand, other psychometric outcomes such as electroencephalographic response and grades of portosystemic encephalopathy were superior in patients treated with rifaximin in comparison to the control group (WMD = 0.21, 95% CI: -0.33-0.09, P = 0.0004; and WMD = -2.33, 95% CI: -2.68-1.98, P = 0.00001, respectively). Subgroup and sensitivity analysis did not show any significant difference in the above findings. CONCLUSION: Rifaximin appears to be at least as effective as other conventional oral agents for the treatment of HE with a better safety profile. PMID:22371636

  12. Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials.

    PubMed

    Wang, Kang-Feng; Zhang, Li-Juan; Lu, Feng; Lu, Yong-Hui; Yang, Chuan-Hua

    2016-06-01

    To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. A comprehensive search [PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. RevMan 5.0 was used for data synthesis. Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio (OR): 5.89, 95% confidence interval (CI): 2.97 to 11.67, P<0.01, heterogeneity: χ(2) =3.81, P=0.70, I (2) =0% ]. One trial compared Ashi points stimulation with drug therapy. The result showed there was a significantly greater recovery rate in group of Ashi points stimulation (OR: 9.58, 95% CI: 2.69 to 34.12). One trial compared comprehensive treatment on the myofascial trigger points (MTrPs) with no treatment and the result was in favor of MTrPs. Ashi points stimulation might be superior to conventional acupuncture, drug therapy and no treatment for shoulder pain. However, due to the low methodological quality of included studies, a firm conclusion could not be reached until further studies of high quality are available.

  13. Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial.

    PubMed

    Andrews, Jeannette O; Mueller, Martina; Dooley, Mary; Newman, Susan D; Magwood, Gayenell S; Tingen, Martha S

    2016-09-01

    To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. A Randomized Experimental Study of Gender-Responsive Substance Abuse Treatment for Women in Prison

    PubMed Central

    Messina, Nena; Grella, Christine E.; Cartier, Jerry; Torres, Stephanie

    2009-01-01

    This experimental pilot study compared post-release outcomes for 115 women who participated in prison-based substance abuse treatment. Women were randomized to a gender-responsive treatment (GRT) program using manualized curricula (Helping Women Recover and Beyond Trauma) or a standard prison-based therapeutic community (TC). Data were collected from the participants at prison program entry and 6 and 12 months after release. Bivariate and multivariate analyses were conducted. Results indicate that both groups improved in psychological well-being; however, GRT participants had greater reductions in drug use, were more likely to remain in residential aftercare longer (2.6 months vs. 1.8 months, p < .05), and were less likely to have been reincarcerated within 12 months after parole (31% vs. 45%, respectively; a 67% reduction in odds for the experimental group, p < .05). Findings show the beneficial effects of treatment components oriented toward women's needs and support the integration of GRT in prison programs for women. PMID:20015605

  15. Obstetric History and Likelihood of Preterm Birth of Twins.

    PubMed

    Easter, Sarah Rae; Little, Sarah E; Robinson, Julian N; Mendez-Figueroa, Hector; Chauhan, Suneet P

    2018-01-05

     The objective of this study was to investigate the relationship between preterm birth in a prior pregnancy and preterm birth in a twin pregnancy.  We performed a secondary analysis of a randomized controlled trial evaluating 17-α-hydroxyprogesterone caproate in twins. Women were classified as nulliparous, multiparous with a prior term birth, or multiparous with a prior preterm birth. We used logistic regression to examine the odds of spontaneous preterm birth of twins before 35 weeks according to past obstetric history.  Of the 653 women analyzed, 294 were nulliparas, 310 had a prior term birth, and 49 had a prior preterm birth. Prior preterm birth increased the likelihood of spontaneous delivery before 35 weeks (adjusted odds ratio [aOR]: 2.44, 95% confidence interval [CI]: 1.28-4.66), whereas prior term delivery decreased these odds (aOR: 0.55, 95% CI: 0.38-0.78) in the current twin pregnancy compared with the nulliparous reference group. This translated into a lower odds of composite neonatal morbidity (aOR: 0.38, 95% CI: 0.27-0.53) for women with a prior term delivery.  For women carrying twins, a history of preterm birth increases the odds of spontaneous preterm birth, whereas a prior term birth decreases odds of spontaneous preterm birth and neonatal morbidity for the current twin pregnancy. These results offer risk stratification and reassurance for clinicians. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  16. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study.

    PubMed

    Abraha, Iosief; Cherubini, Antonio; Cozzolino, Francesco; De Florio, Rita; Luchetta, Maria Laura; Rimland, Joseph M; Folletti, Ilenia; Marchesi, Mauro; Germani, Antonella; Orso, Massimiliano; Eusebi, Paolo; Montedori, Alessandro

    2015-05-27

    To examine whether deviation from the standard intention to treat analysis has an influence on treatment effect estimates of randomised trials. Meta-epidemiological study. Medline, via PubMed, searched between 2006 and 2010; 43 systematic reviews of interventions and 310 randomised trials were included. From each year searched, random selection of 5% of intervention reviews with a meta-analysis that included at least one trial that deviated from the standard intention to treat approach. Basic characteristics of the systematic reviews and randomised trials were extracted. Information on the reporting of intention to treat analysis, outcome data, risk of bias items, post-randomisation exclusions, and funding were extracted from each trial. Trials were classified as: ITT (reporting the standard intention to treat approach), mITT (reporting a deviation from the standard approach), and no ITT (reporting no approach). Within each meta-analysis, treatment effects were compared between mITT and ITT trials, and between mITT and no ITT trials. The ratio of odds ratios was calculated (value <1 indicated larger treatment effects in mITT trials than in other trial categories). 50 meta-analyses and 322 comparisons of randomised trials (from 84 ITT trials, 118 mITT trials, and 108 no ITT trials; 12 trials contributed twice to the analysis) were examined. Compared with ITT trials, mITT trials showed a larger intervention effect (pooled ratio of odds ratios 0.83 (95% confidence interval 0.71 to 0.96), P=0.01; between meta-analyses variance τ(2)=0.13). Adjustments for sample size, type of centre, funding, items of risk of bias, post-randomisation exclusions, and variance of log odds ratio yielded consistent results (0.80 (0.69 to 0.94), P=0.005; τ(2)=0.08). After exclusion of five influential studies, results remained consistent (0.85 (0.75 to 0.98); τ(2)=0.08). The comparison between mITT trials and no ITT trials showed no statistical difference between the two groups (adjusted ratio of odds ratios 0.92 (0.70 to 1.23); τ(2)=0.57). Trials that deviated from the intention to treat analysis showed larger intervention effects than trials that reported the standard approach. Where an intention to treat analysis is impossible to perform, authors should clearly report who is included in the analysis and attempt to perform multiple imputations. © Abraha et al 2015.

  17. A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

    PubMed

    Koch, Colleen G; Sessler, Daniel I; Mascha, Edward J; Sabik, Joseph F; Li, Liang; Duncan, Andra I; Zimmerman, Nicole M; Blackstone, Eugene H

    2017-10-01

    Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial

    PubMed Central

    Xu, Sha-bei; Huang, Bo; Zhang, Chen-yan; Du, Peng; Yuan, Qi; Bi, Gui-juan; Zhang, Gui-bin; Xie, Min-jie; Luo, Xiang; Huang, Guang-ying; Wang, Wei

    2013-01-01

    Background: The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi, which is necessary to achieve the best therapeutic effect. De qi is an internal compound sensation of soreness, tingling, fullness, aching, cool, warmth and heaviness, and a radiating sensation at and around the acupoints. However, the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence. Methods: We performed a prospective multicentre randomized controlled trial involving patients with Bell palsy. Patients were randomly assigned to the de qi (n = 167) or control (n = 171) group. Both groups received acupuncture: in the de qi group, the needles were manipulated manually until de qi was reached, whereas in the control group, the needles were inserted without any manipulation. All patients received prednisone as a basic treatment. The primary outcome was facial nerve function at month 6. We also assessed disability and quality of life 6 months after randomization. Results: After 6 months, patients in the de qi group had better facial function (adjusted odds ratio [OR] 4.16, 95% confidence interval [CI] 2.23–7.78), better disability assessment (differences of least squares means 9.80, 95% CI 6.29–13.30) and better quality of life (differences of least squares means 29.86, 95% CI 22.33–37.38). Logistic regression analysis showed a positive effect of the de qi score on facial-nerve function (adjusted OR 1.07, 95% CI 1.04–1.09). Interpretation: Among patients with Bell palsy, acupuncture with strong stimulation that elicited de qi had a greater therapeutic effect, and stronger intensity of de qi was associated with the better therapeutic effects. Trial registration: Clinicaltrials.gov no. NCT00685789. PMID:23439629

  19. Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

    PubMed

    Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C

    2018-06-01

    US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. Regression discontinuity was a valid design for dichotomous outcomes in three randomized trials.

    PubMed

    van Leeuwen, Nikki; Lingsma, Hester F; Mooijaart, Simon P; Nieboer, Daan; Trompet, Stella; Steyerberg, Ewout W

    2018-06-01

    Regression discontinuity (RD) is a quasi-experimental design that may provide valid estimates of treatment effects in case of continuous outcomes. We aimed to evaluate validity and precision in the RD design for dichotomous outcomes. We performed validation studies in three large randomized controlled trials (RCTs) (Corticosteroid Randomization After Significant Head injury [CRASH], the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries [GUSTO], and PROspective Study of Pravastatin in elderly individuals at risk of vascular disease [PROSPER]). To mimic the RD design, we selected patients above and below a cutoff (e.g., age 75 years) randomized to treatment and control, respectively. Adjusted logistic regression models using restricted cubic splines (RCS) and polynomials and local logistic regression models estimated the odds ratio (OR) for treatment, with 95% confidence intervals (CIs) to indicate precision. In CRASH, treatment increased mortality with OR 1.22 [95% CI 1.06-1.40] in the RCT. The RD estimates were 1.42 (0.94-2.16) and 1.13 (0.90-1.40) with RCS adjustment and local regression, respectively. In GUSTO, treatment reduced mortality (OR 0.83 [0.72-0.95]), with more extreme estimates in the RD analysis (OR 0.57 [0.35; 0.92] and 0.67 [0.51; 0.86]). In PROSPER, similar RCT and RD estimates were found, again with less precision in RD designs. We conclude that the RD design provides similar but substantially less precise treatment effect estimates compared with an RCT, with local regression being the preferred method of analysis. Copyright © 2018 Elsevier Inc. All rights reserved.

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