Reduced availability of sugar-sweetened beverages and diet soda has a limited impact on beverage consumption patterns in Maine high school youth.

PubMed

Blum, Janet E Whatley; Davee, Anne-Marie; Beaudoin, Christina M; Jenkins, Paul L; Kaley, Lori A; Wigand, Debra A

2008-01-01

To examine change in high school students' beverage consumption patterns pre- and post-intervention of reduced availability of sugar-sweetened beverages (SSB) and diet soda in school food venues. A prospective, quasi-experimental, nonrandomized study design. Public high schools. A convenience sample from control (n = 221) and intervention (n = 235) high schools. Schools aimed to reduce (n = 4) or not change (n = 3) availability of SSB and diet soda in food venues for 1 school year. Subjects' beverage servings/day was determined from a food frequency questionnaire pre- and post-intervention. Two-by-two mixed analysis of variance model compared pre- to post-intervention servings/day between control and intervention subjects, stratified by gender. Consumption of SSB decreased in both intervention and control boys (F = 53.69, P < .05) and girls (F = 22.87, P < .05). Intervention girls decreased diet soda consumption as compared to control girls (F = 6.57, P < .05). Reducing availability of SSB in schools did not result in a greater decrease in SSB consumption by intervention as compared to control subjects. The impact of reducing availability of SSB at school may be limited. A better understanding of beverage consumption patterns may be needed to determine the efficacy of school food policies on those youth susceptible to obesity.

Commentary: The Challenge of Nonexperimental Interventions Studies in Social Work

ERIC Educational Resources Information Center

Schilling, Robert

2010-01-01

The challenging context of social work interventions require that most intervention studies will be derived from nonexperimental research designs. Two evaluation studies in this special issue employed nonrandomized designs to examine the efficacy of two programs--a police crisis intervention team designed to enhance officers' responses to mental…

Does school-based physical activity decrease overweight and obesity in children aged 6-9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic.

PubMed

Sigmund, Erik; El Ansari, Walid; Sigmundová, Dagmar

2012-07-29

Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of control children (p < 0.005), and these odds steadily decreased with the duration of the intervention. The findings suggest that school-based PA (Physical Education lessons, PA during short breaks and longer recesses, PA at after-school nursery) in compatible active environments (child-friendly gym and school playground, corridors with movement and playing around corners and for games) has a vital role in obesity and overweight reduction among younger pupils.

Does school-based physical activity decrease overweight and obesity in children aged 6–9 years? A two-year non-randomized longitudinal intervention study in the Czech Republic

PubMed Central

2012-01-01

Background Globally, efforts aimed at the prevention of childhood obesity have led to the implementation of a range of school-based interventions. This study assessed whether augmenting physical activity (PA) within the school setting resulted in increased daily PA and decreased overweight/obesity levels in 6-9-year-old children. Methods Across the first to third primary school years, PA of 84 girls and 92 boys was objectively monitored five times (each for seven successive days) using Yamax pedometer (step counts) and Caltrac accelerometer (activity energy expenditure AEE - kcal/kg per day). Four schools were selected to participate in the research (2 intervention, 2 controls), comprising intervention (43 girls, 45 boys) and control children (41 girls, 47 boys). The study was non-randomized and the intervention schools were selected on the basis of existing PA-conducive environment. Analyses of variance (ANOVA) for repeated measures examined the PA programme and gender effects on the step counts and AEE. Logistic regression (Enter method) determined the obesity and overweight occurrence prospect over the course of implementation of the PA intervention. Results There was a significant increase of school-based PA during schooldays in intervention children (from ≈ 1718 to ≈ 3247 steps per day; and from 2.1 to ≈ 3.6 Kcal/Kg per day) in comparison with the control children. Increased school-based PA of intervention children during schooldays contributed to them achieving >10,500 steps and >10.5 Kcal/Kg per school day across the 2 years of the study, and resulted in a stop of the decline in PA levels that is known to be associated with the increasing age of children. Increased school-based PA had also positive impact on leisure time PA of schooldays and on PA at weekends of intervention children. One year after the start of the PA intervention, the odds of being overweight or obese in the intervention children was almost three times lower than that of control children (p < 0.005), and these odds steadily decreased with the duration of the intervention. Conclusions The findings suggest that school-based PA (Physical Education lessons, PA during short breaks and longer recesses, PA at after-school nursery) in compatible active environments (child-friendly gym and school playground, corridors with movement and playing around corners and for games) has a vital role in obesity and overweight reduction among younger pupils. PMID:22892226

Hybrid natural orifice transluminal endoscopic cholecystectomy: prospective human series.

PubMed

Cuadrado-Garcia, Angel; Noguera, Jose F; Olea-Martinez, Jose M; Morales, Rafael; Dolz, Carlos; Lozano, Luis; Vicens, Jose-Carlos; Pujol, Juan José

2011-01-01

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. Currently, it is not possible to perform these interventions without the help of abdominal wall entryways, so these procedures are hybrids fusing minilaparoscopy and transluminal endoscopic surgery. This report presents a prospective clinical series of 25 patients who underwent transvaginal hybrid cholecystectomy for cholelithiasis. The study comprised a clinical series of 25 consecutive nonrandomized women who underwent a fusion transvaginal NOTES and minilaparoscopy procedure with two trocars for cholelithiasis: one 5-mm umbilical trocar and one 3-mm trocar in the upper left quadrant. The study had no control group. The scheduled surgical intervention was performed for all 25 women. No intraoperative complications occurred. One patient had mild hematuria that resolved in less than 12 h, but no other complications occurred during an average follow-up period of 140 days. Of the 25 women, 20 were discharged in 24 h, and 5 were discharged less than 12 h after the procedure. Hybrid transvaginal cholecystectomy, combining NOTES and minilaparoscopy, is a good surgical model for minimally invasive surgery. It can be performed in surgical settings where laparoscopy is practiced regularly using the instruments normally used for endoscopy and laparoscopic surgery. Due to the reproducibility of the intervention and the ease of vaginal closure, hybrid transvaginal cholecystectomy will permit further development of NOTES in the future.

School-Based Intervention for Test Anxiety

ERIC Educational Resources Information Center

Yeo, Lay See; Goh, Valerie Grace; Liem, Gregory Arief D.

2016-01-01

Background: With children today being tested at younger ages, test anxiety has an earlier onset age. There is relatively limited research on test anxiety management programs with elementary school children. The theoretical basis for this nonrandomized pre-post intervention study is grounded in cognitive and behavioral interventions for test…

Evaluation of an educational, theater-based intervention on attitudes toward organ donation in Risaralda, Colombia

PubMed Central

Buitrago, Juliana; Gómez, Sandra; Guerra, Alvaro; Lucumí, Leidy; Romero, César

2013-01-01

Introduction: The shortage of organs for transplantation is a worldwide problem and the main cause is the refusal of family members to donate. Consent to donate is influenced by many factors and educational interventions are strongly recommended. Objective: To evaluate the impact of an educational, theaterbased strategy on the attitudes toward organ donation. Methods: This study employed an intervention using theater as the central tool. The impact of this intervention on the intention to donate was assessed through a controlled, prospective, nonrandomized designed study. The sample consisted of 1,038 people. All the participants answered a survey that asked about sex, age and intent to donate. Afterward, one portion of the sample was exposed to the play, The Gift of Life, and a subsequent discussion forum that was guided by experts. The same survey was administered again after the intervention. Results: Before the intervention, donation attitudes were positive in 68.3% of the responses, negative in 6.8% and uncertain in 24.9%. Females showed a greater intent to donate while age had no apparent influence on the donation decision. Those exposed to the intervention were found to be more likely to donate and show a favorable change in attitude toward donation than those who were not exposed to the intervention. Conclusion: An educational intervention using theater is an effective tool to generate a short-term change in the intent to donate. Educational strategies should be employed to increase the rates of organ donation. PMID:24892320

A Systematic Review of Antimicrobial Stewardship Interventions in the Emergency Department.

PubMed

Losier, Mia; Ramsey, Tasha D; Wilby, Kyle John; Black, Emily K

2017-09-01

To improve antimicrobial utilization, development and implementation of antimicrobial stewardship programs in the emergency department (ED) has been recommended. The primary objective of this review was to characterize antimicrobial stewardship (AMS) in the ED and to identify interventions that improve patient outcomes or process of care and/or reduce consequences of antimicrobial use. This study was completed as a systematic review. The following databases were searched from inception through November, 2016: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Scopus, and Web of Science. Randomized controlled trials, nonrandomized controlled trials, controlled and uncontrolled before-and-after studies, interrupted time series studies, and repeated-measures studies evaluating AMS interventions in the ED were included in the review. Studies published in languages other than English were excluded. A total of 43 studies meeting inclusion criteria were identified from our search. Patient or provider education and guideline or clinical pathway implementation were the most commonly reported interventions. Few studies reported on audit and feedback, and no study evaluated preauthorization. Impact of interventions showed variable results. Where identified, benefits of AMS interventions primarily included improvement in delivery of care or a decrease in antimicrobial utilization; however, most studies were rated as having unclear or high risk of bias. AMS interventions in the ED may improve patient care. However, the optimal combination of interventions is unclear. Additional studies with more rigorous design evaluating core components of AMS programs, including prospective audit and feedback are needed.

A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

ERIC Educational Resources Information Center

Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

2012-01-01

Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

Lifestyle intervention for adults with spinal cord injury: Results of the USC-RLANRC Pressure Ulcer Prevention Study.

PubMed

Carlson, Mike; Vigen, Cheryl Lp; Rubayi, Salah; Blanche, Erna Imperatore; Blanchard, Jeanine; Atkins, Michal; Bates-Jensen, Barbara; Garber, Susan L; Pyatak, Elizabeth A; Diaz, Jesus; Florindez, Lucia I; Hay, Joel W; Mallinson, Trudy; Unger, Jennifer B; Azen, Stanley Paul; Scott, Michael; Cogan, Alison; Clark, Florence

2017-04-17

Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect. ClinicalTrials.gov NCT01999816.

Does a diet low in FODMAPs reduce symptoms associated with functional gastrointestinal disorders? A comprehensive systematic review and meta-analysis.

PubMed

Marsh, Abigail; Eslick, Enid M; Eslick, Guy D

2016-04-01

Functional gastrointestinal symptoms such as abdominal pain, bloating, distension, constipation, diarrhea and flatulence have been noted in patients with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). The diversity of symptoms has meant that finding an effective treatment has been challenging with most treatments alleviating only the primary symptom. A novel treatment option for IBS and IBD currently generating much excitement is the low fermentable, oligo-, di-, mono-saccharides and polyol (FODMAP) diet. The aim of this meta-analysis was to determine the evidence of the efficacy of such a diet in the treatment of functional gastrointestinal symptoms. Electronic databases were searched through to March 2015 to identify relevant studies. Pooled odds ratios (ORs) and 95 % confidence intervals were calculated for the effect of a low FODMAP diet on the reduction in IBS [Symptoms Severity Score (SSS)] score and increase in IBS quality of life (QOL) score for both randomized clinical trials (RCTs) and non-randomized interventions using a random-effects model. Six RCTs and 16 non-randomized interventions were included in the analysis. There was a significant decrease in IBS SSS scores for those individuals on a low FODMAP diet in both the RCTs (OR 0.44, 95 % CI 0.25-0.76; I (2) = 35.52, p = 0.00) and non-randomized interventions (OR 0.03, 95 % CI 0.01-0.2; I (2) = 69.1, p = 0.02). In addition, there was a significant improvement in the IBS-QOL score for RCTs (OR 1.84, 95 % CI 1.12-3.03; I (2) = 0.00, p = 0.39) and for non-randomized interventions (OR 3.18, 95 % CI 1.60-6.31; I (2) = 0.00, p = 0.89). Further, following a low FODMAP diet was found to significantly reduce symptom severity for abdominal pain (OR 1.81, 95 % CI 1.13-2.88; I (2) = 0.00, p = 0.56), bloating (OR 1.75, 95 % CI 1.07-2.87; I (2) = 0.00, p = 0.45) and overall symptoms (OR 1.81, 95 % CI 1.11-2.95; I (2) = 0.00, p = 0.4) in the RCTs. In the non-randomized interventions similar findings were observed. The present meta-analysis supports the efficacy of a low FODMAP diet in the treatment of functional gastrointestinal symptoms. Further research should ensure studies include dietary adherence, and more studies looking at greater number of patients and long-term adherence to a low FODMAP diet need to be conducted.

The Role of Need for Contraception in the Evaluation of Interventions to Improve Access to Family-Planning Methods

ERIC Educational Resources Information Center

Leon, Federico R.; Lundgren, Rebecka; Sinai, Irit; Jennings, Victoria

2011-01-01

A nonrandomized experiment carried out in Jharkhand, India, shows how the effects of interventions designed to improve access to family-planning methods can be erroneously regarded as trivial when contraceptive use is utilized as dependent variable, ignoring women's need for contraception. Significant effects of the intervention were observed on…

Non-random mating and convergence over time for alcohol consumption, smoking, and exercise: the Nord-Trøndelag Health Study.

PubMed

Ask, Helga; Rognmo, Kamilla; Torvik, Fartein Ask; Røysamb, Espen; Tambs, Kristian

2012-05-01

Spouses tend to have similar lifestyles. We explored the degree to which spouse similarity in alcohol use, smoking, and physical exercise is caused by non-random mating or convergence. We used data collected for the Nord-Trøndelag Health Study from 1984 to 1986 and prospective registry information about when and with whom people entered marriage/cohabitation between 1970 and 2000. Our sample included 19,599 married/cohabitating couples and 1,551 future couples that were to marry/cohabitate in the 14-16 years following data collection. All couples were grouped according to the duration between data collection and entering into marriage/cohabitation. Age-adjusted polychoric spouse correlations were used as the dependent variables in non-linear segmented regression analysis; the independent variable was time. The results indicate that spouse concordance in lifestyle is due to both non-random mating and convergence. Non-random mating appeared to be strongest for smoking. Convergence in alcohol use and smoking was evident during the period prior to marriage/cohabitation, whereas convergence in exercise was evident throughout life. Reduced spouse similarity in smoking with relationship duration may reflect secular trends.

Tackling inequalities in obesity: a protocol for a systematic review of the effectiveness of public health interventions at reducing socioeconomic inequalities in obesity among adults.

PubMed

Bambra, Clare L; Hillier, Frances C; Moore, Helen J; Cairns-Nagi, Joanne-Marie; Summerbell, Carolyn D

2013-05-10

Socioeconomic inequalities in obesity and associated risk factors for obesity are widening throughout developed countries worldwide. Tackling obesity is high on the public health agenda both in the United Kingdom and internationally. However, what works in terms of interventions that are able to reduce inequalities in obesity is lacking. The review will examine public health interventions at the individual, community and societal level that might reduce inequalities in obesity among adults aged 18 years and over, in any setting and in any country. The following electronic databases will be searched: MEDLINE, EMBASE, CINAHL, PsycINFO, Social Science Citation Index, ASSIA, IBSS, Sociological Abstracts, and the NHS Economic Evaluation Database. Database searches will be supplemented with website and gray literature searches. No studies will be excluded based on language, country or publication date. Randomized and non-randomized controlled trials, prospective and retrospective cohort studies (with/without control groups) and prospective repeat cross-sectional studies (with/without control groups) that have a primary outcome that is a proxy for body fatness and have examined differential effects with regard to socioeconomic status (education, income, occupation, social class, deprivation, poverty) or where the intervention has been targeted specifically at disadvantaged groups or deprived areas will be included. Study inclusion, data extraction and quality appraisal will be conducted by two reviewers. Meta-analysis and narrative synthesis will be conducted. The main analysis will examine the effects of 1) individual, 2) community and 3) societal level public health interventions on socioeconomic inequalities in adult obesity. Interventions will be characterized by their level of action and their approach to tackling inequalities. Contextual information on how such public health interventions are organized, implemented and delivered will also be examined. The review will provide evidence, and reveal any gaps in the evidence base, of public health strategies which reduce and prevent inequalities in the prevalence of obesity in adults and provide information on the organization, implementation and delivery of such interventions. PROSPERO registration number: CRD42013003612.

Mindfulness Meditation for Substance Use Disorders: A Systematic Review

PubMed Central

Zgierska, Aleksandra; Rabago, David; Chawla, Neharika; Kushner, Kenneth; Koehler, Robert; Marlatt, Allan

2009-01-01

Relapse is common in substance use disorders (SUDs), even among treated individuals. The goal of this article was to systematically review the existing evidence on mindfulness meditation-based interventions (MM) for SUDs. The comprehensive search for and review of literature found over 2,000 abstracts and resulted in 25 eligible manuscripts (22 published, 3 unpublished: 8 RCTs, 7 controlled non-randomized, 6 non-controlled prospective, 2 qualitative studies, 1 case report). When appropriate, methodological quality, absolute risk reduction, number needed to treat, and effect size (ES) were assessed. Overall, although preliminary evidence suggests MM efficacy and safety, conclusive data for MM as a treatment of SUDs are lacking. Significant methodological limitations exist in most studies. Further, it is unclear which persons with SUDs might benefit most from MM. Future trials must be of sufficient sample size to answer a specific clinical question and should target both assessment of effect size and mechanisms of action. PMID:19904664

Short-term intake of a Japanese-style healthy lunch menu contributes to prevention and/or improvement in metabolic syndrome among middle-aged men: a non-randomized controlled trial

PubMed Central

2014-01-01

Background Metabolic syndrome is now widely appreciated as a cluster of metabolic abnormalities such as visceral obesity, hypertension, hyperglycemia and dyslipidemia. To date, incidence of metabolic syndrome is continuously increasing worldwide. In addition, low vegetable consumption has recently become a serious issue in Japan. Furthermore, Japan is facing a shortfall in places offering food that can help prevent metabolic syndrome in the first place. Our study is designed to influence these developments. We conducted a non-randomized controlled trial by offering a Japanese-style healthy lunch menu to middle-aged men in a workplace cafeteria. This menu was designed to prevent and reduce metabolic syndrome. Methods This intervention study took the form of a non-randomized controlled trial. Participants chose the control or intervention group. The control group consumed their habitual lunches without restriction and only nutrient contents were assessed. The intervention group received a Japanese-style healthy lunch at a workplace cafeteria for 3 months. The participants worked in offices at a city hall and mostly had low levels of physical activity. Data of 35 males (control group: 7 males, intervention group: 28 males, mean age: 47.2 ± 7.9 years) were collected and analyzed. Results We obtained an effective outcome by demonstrating that ongoing intake of a Japanese-style healthy lunch decreased blood pressure and serum lipids and increased plasma ghrelin levels. The results grew more pronounced as intake of Japanese-style healthy lunches increased in frequency. Conclusions This study presents new empirical data as a result of an original intervention program undertaken in Japan. A Japanese-style healthy lunch menu containing many vegetables consumed can help prevent and/or improve metabolic syndrome. PMID:24673894

Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

PubMed Central

Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

2016-01-01

Background. Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Materials and Methods. Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. Results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532). Conclusion. This is the largest reported study examining why oncology trials are not published. The data show that 4−6 years after appearing as abstracts, 39% of oncology clinical trials remain unpublished. Larger sample size and advanced trial phase were associated with eventual publication; among randomized trials, an industry-affiliated author or a cooperative group increased likelihood of publication. Unfortunately, we found that, despite widespread recognition of the problem and the creation of central data repositories, timely publishing of oncology clinical trials results remains unsatisfactory. Implications for Practice: The Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects notes the ethical obligation to report clinical trial data, whether positive or negative. This obligation is listed alongside requirements for risk minimization, access, confidentiality, and informed consent, all bedrocks of the clinical trial system, yet clinical trials are often not published, particularly if negative or difficult to complete. This study found that among American Society for Clinical Oncology (ASCO) Annual Meeting abstracts, 2009–2011, only 61% were published 4–6 years later: 75% of randomized trials and 54% of nonrandomized trials. Clinicians need to insist that every study in which they participate is published. PMID:26888691

Factors Influencing Functional Outcomes and Return-to-Work After Amputation: A Review of the Literature.

PubMed

Darter, Benjamin J; Hawley, Carolyn E; Armstrong, Amy J; Avellone, Lauren; Wehman, Paul

2018-02-03

Purpose Amputation is a life changing event that can significantly impact an individual's physical and mental well-being. Our objective was to review literature exploring the impact of amputation upon a person's functioning and inclusion in the workplace. Methods Medline, CINAHL, and PsycINFO were searched using keywords related to amputation, employment and community reintegration. Eligible studies were published since 2000 and one of the following study designs: randomized controlled trial, non-randomized controlled trial, retrospective study, prospective study, concurrent cohort study, or cross sectional study. Studies for civilians with amputation as well as service members and Veterans with amputation were considered for inclusion. Results The search identified 995 articles, 25 of which met inclusion/exclusion criteria and were included in the review. While strong evidence for correlations and predictors of outcomes after amputation were limited, multiple factors were identified as contributing to physical functioning and employment after amputation. Conclusions Outcomes after amputation can vary widely with many potentially inter-related factors contributing. The factors identified may also serve to inform the development of interventions aiming to improve functional performance and reintegration after amputation. Furthermore, the review highlights the need for more high quality prospective studies.

Implementation of a Nutrition Program Reduced Post-Discharge Growth Restriction in Thai Very Low Birth Weight Preterm Infants.

PubMed

Japakasetr, Suchada; Sirikulchayanonta, Chutima; Suthutvoravut, Umaporn; Chindavijak, Busba; Kagawa, Masaharu; Nokdee, Somjai

2016-12-17

Very low birth weight (VLBW) preterm infants are vulnerable to growth restriction after discharge due to cumulative protein and energy deficits during their hospital stay and early post-discharge period. The current study evaluated the effectiveness of the preterm infant, post-discharge nutrition (PIN) program to reduce post-discharge growth restriction in Thai VLBW preterm infants. A prospective, non-randomized interventional cohort study was undertaken to assess the growth of 22 VLBW preterm infants who received the PIN program and compared them with 22 VLBW preterm infants who received conventional nutrition services. Infant's growth was recorded monthly until the infants reached six months' corrected age (6-moCA). Intervention infants had significantly greater body weights ( p = 0.013) and head circumferences ( p = 0.009). Also, a greater proportion of the intervention group recovered their weight to the standard weight at 4-moCA ( p = 0.027) and at 6-moCA ( p = 0.007) and their head circumference to the standard head circumference at 6-moCA ( p = 0.004) compared to their historical comparison counterparts. Enlistment in the PIN program thus resulted in significantly reduced post-discharge growth restriction in VLBW preterm infants. Further research on longer term effects of the program on infant's growth and development is warranted.

Evaluation of physical activity interventions in children via the reach, efficacy/effectiveness, adoption, implementation, and maintenance (RE-AIM) framework: A systematic review of randomized and non-randomized trials.

PubMed

McGoey, Tara; Root, Zach; Bruner, Mark W; Law, Barbi

2016-01-01

Existing reviews of physical activity (PA) interventions designed to increase PA behavior exclusively in children (ages 5 to 11years) focus primarily on the efficacy (e.g., internal validity) of the interventions without addressing the applicability of the results in terms of generalizability and translatability (e.g., external validity). This review used the RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, Maintenance) framework to measure the degree to which randomized and non-randomized PA interventions in children report on internal and external validity factors. A systematic search for controlled interventions conducted within the past 12years identified 78 studies that met the inclusion criteria. Based on the RE-AIM criteria, most of the studies focused on elements of internal validity (e.g., sample size, intervention location and efficacy/effectiveness) with minimal reporting of external validity indicators (e.g., representativeness of participants, start-up costs, protocol fidelity and sustainability). Results of this RE-AIM review emphasize the need for future PA interventions in children to report on real-world challenges and limitations, and to highlight considerations for translating evidence-based results into health promotion practice. Copyright © 2015 Elsevier Inc. All rights reserved.

Nitroglycerin can facilitate weaning of difficult-to-wean chronic obstructive pulmonary disease patients: a prospective interventional non-randomized study

PubMed Central

2010-01-01

Introduction Both experimental and clinical data give convincing evidence to acute cardiac dysfunction as the origin or a cofactor of weaning failure in patients with chronic obstructive pulmonary disease. Therefore, treatment targeting the cardiovascular system might help the heart to tolerate more effectively the critical period of weaning. This study aims to assess the hemodynamic, respiratory and clinical effects of nitroglycerin infusion in difficult-to-wean patients with severe chronic obstructive pulmonary disease. Methods Twelve difficult-to-wean (failed ≥ 3 consecutive trials) chronic obstructive pulmonary disease patients, who presented systemic arterial hypertension (systolic blood pressure ≥ 140mmHg) during weaning failure and had systemic and pulmonary artery catheters in place, participated in this prospective, interventional, non-randomized clinical trial. Patients were studied in two consecutive days, i.e., the first day without (Control day) and the second day with (Study day) nitroglycerin continuous intravenous infusion starting at the beginning of the spontaneous breathing trial, and titrated to maintain normal systolic blood pressure. Hemodynamic, oxygenation and respiratory measurements were performed on mechanical ventilation, and during a 2-hour T-piece spontaneous breathing trial. Primary endpoint was hemodynamic and respiratory effects of nitroglycerin infusion. Secondary endpoint was spontaneous breathing trial and extubation outcome. Results Compared to mechanical ventilation, mean systemic arterial pressure, rate-pressure product, mean pulmonary arterial pressure, and pulmonary artery occlusion pressure increased [from (mean ± SD) 94 ± 14, 13708 ± 3166, 29.9 ± 4.8, and 14.8 ± 3.8 to 109 ± 20mmHg, 19856 ± 4877mmHg b/min, 41.6 ± 5.8mmHg, and 23.4 ± 7.4 mmHg, respectively], and mixed venous oxygen saturation decreased (from 75.7 ± 3.5 to 69.3 ± 7.5%) during failing trials on Control day, whereas they did not change on Study day. Venous admixture increased throughout the trial on both Control day and Study day, but this increase was lower on Study day. Whereas weaning failed in all patients on Control day, nitroglycerin administration on Study day enabled a successful spontaneous breathing trial and extubation in 92% and 88% of patients, respectively. Conclusions In this clinical setting, nitroglycerin infusion can expedite the weaning by restoring weaning-induced cardiovascular compromise. PMID:21078149

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

Stage-Based Healthy Lifestyles Program for Non-College Young Adults

ERIC Educational Resources Information Center

Walsh, Jennifer; Kattelmann, Kendra; White, Adrienne

2017-01-01

Purpose: The purpose of this paper is to test the feasibility of implementing a healthy lifestyles intervention to maintain or achieve healthy weight for low-income young adults in vocational education. Design/methodology/approach: Non-randomized, quasi-experimental feasibility test of a ten-week intervention with follow-up assessment designed…

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

PubMed

Manchikanti, Laxmaiah; Malla, Yogesh; Wargo, Bradley W; Cash, Kimberly A; Pampati, Vidyasagar; Fellows, Bert

2012-01-01

Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks. A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. A private interventional pain management practice, a specialty referral center in the United States. Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively. This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications. There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar region, and 6% in thoracic region; local bleeding in 76.3% of episodes with highest in thoracic region and lowest in cervical region; oozing with 19.6% encounters with highest in cervical region and lowest in lumbar region; with local hematoma seen only in 1.2% of the patients with profuse bleeding, bruising, soreness, nerve root irritation, and all other effects such as vasovagal reactions observed in 1% or less of the episodes. Limitations of this study include lack of contrast injection, use of intermittent fluoroscopy and also an observational nature of the study. This study illustrate that major complications are extremely rare and minor side effects are common.

Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

PubMed

DiDiodato, Giulio; McArthur, Leslie

2016-01-01

The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium difficile as measured by the ward's previous month's total CDI cases (CDI Lag) and the ward's current month's community-associated CDI cases (CA-CDI) was significantly associated with an increased risk of HA-CDI, with the estimated CDI Lag IRR of 1.21 (95% 1.15, 1.28) and the estimated CA-CDI IRR of 1.10 (95% CI 1.01, 1.20). The ward-level random intercept and slope coefficients were not significant. The final model demonstrated good fit. In this study, a daily prospective audit and feedback ASi resulted in a significant reduction in the risk of HA-CDI on the medicine wards, however, this effect was independent of an overall reduction in antibiotic utilization. In addition, the ward-level burden of Clostridium difficile was shown to significantly increase the risk of HA-CDI, reinforcing the importance of the environment as a source of HA-CDI.

Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures

PubMed Central

Page, Michael A; Fraunfelder, Frederick W

2009-01-01

Purpose: To review the current literature on safety, efficacy, and measures of surgeon and patient satisfaction with lidocaine hydrochloride gel as a tool for ocular anesthesia. Methods: Pubmed search using keywords “lidocaine gel,” “ophthalmic,” and “surgery” and compiling cross-references. Twenty-six total references were reviewed, including 15 prospective randomized controlled trials (RCTs, total N = 933, average N = 62), 6 nonrandomized prospective studies (total N = 234, average N = 39), 2 animal studies, 1 microbiologic study, and 2 letters to the editor. Results: The RCTs and nonrandomized prospective studies evaluated a number of measures including timing of onset of anesthesia, duration of anesthesia, intraoperative and postoperative pain, need for additional anesthetic applications, intracameral lidocaine levels, and adverse effects. Control groups received topical drops, subconjunctival anesthetic, retrobulbar anesthetic, or sham gel. Lidocaine gel was shown to be at least as effective for pain control as alternative therapies in all studies, with longer duration of action than topical drops. Patient and surgeon satisfaction were high, and adverse effects were rare and comparable to those for anesthetic drop formulations. Surgical settings included cataract, pterygium, trabeculectomy, strabismus, intravitreal injection, vitrectomy, and penetrating keratoplasty. Conclusions: Lidocaine gel is a safe, effective, and potentially underutilized tool for ophthalmic surgery. PMID:19898665

Systematic Review of Interventions to Improve the Provision of Information for Adults with Primary Brain Tumors and Their Caregivers

PubMed Central

Langbecker, Danette; Janda, Monika

2014-01-01

Background: Adults with primary brain tumors and their caregivers have significant information needs. This review assessed the effect of interventions to improve information provision for adult primary brain tumor patients and/or their caregivers. Methods: We included randomized or non-randomized trials testing educational interventions that had outcomes of information provision, knowledge, understanding, recall, or satisfaction with the intervention, for adults diagnosed with primary brain tumors and/or their family or caregivers. PubMed, MEDLINE, EMBASE, and Cochrane Reviews databases were searched for studies published between 1980 and June 2014. Results: Two randomized controlled, 1 non-randomized controlled, and 10 single group pre–post trials enrolled more than 411 participants. Five group, four practice/process change, and four individual interventions assessed satisfaction (12 studies), knowledge (4 studies), and information provision (2 studies). Nine studies reported high rates of satisfaction. Three studies showed statistically significant improvements over time in knowledge and two showed greater information was provided to intervention than control group participants, although statistical testing was not performed. Discussion: The trials assessed intermediate outcomes such as satisfaction, and only 4/13 reported on knowledge improvements. Few trials had a randomized controlled design and risk of bias was either evident or could not be assessed in most domains. PMID:25667919

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Impact of a Community-Based Prevention Marketing Intervention to Promote Physical Activity among Middle-Aged Women

ERIC Educational Resources Information Center

Sharpe, Patricia A.; Burroughs, Ericka L.; Granner, Michelle L.; Wilcox, Sara; Hutto, Brent E.; Bryant, Carol A.; Peck, Lara; Pekuri, Linda

2010-01-01

A physical activity intervention applied principles of community-based participatory research, the community-based prevention marketing framework, and social cognitive theory. A nonrandomized design included women ages 35 to 54 in the southeastern United States. Women (n = 430 preprogram, n = 217 postprogram) enrolled in a 24-week behavioral…

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

PubMed Central

Walach, Harald; Falkenberg, Torkel; Fønnebø, Vinjar; Lewith, George; Jonas, Wayne B

2006-01-01

Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform. PMID:16796762

Multifactorial intervention for diabetes control among older users of insulin

PubMed Central

Machry, Rafael Vaz; Pedroso, Henrique Umpierre; Vasconcellos, Luthiele Silva; Nunes, Rafaela Ramos; Evaldt, Cibelle de Abreu; Yunes, Eduardo Bardou; Rodrigues, Ticiana da Costa

2018-01-01

ABSTRACT OBJECTIVE: To evaluate if the closer follow-up with the supply of insulin pens and the measurement of capillary blood glucose improve the management of older patients with type 2 diabetes without adequate glycemic control despite extensive therapy. METHODS: This is a prospective, non-randomized, quasi-experimental study. We have included 45 patients over 60 years old, from both sexes, with glycated hemoglobin (HbA1c) > 8.5% using oral hypoglycemic agents and insulin. The intervention consisted of monthly medical visits, with the provision of insulin pens and strips for blood glucose measurement. All patients received insulin pen, refills of Neutral Protamine Hagedorn and regular insulin, needles for the pen, blood glucose meter, and capillary blood glucose tests (three tests/day). Treatment was adjusted with the same endocrinologist monthly for six months. Glycated hemoglobin was measured at baseline and 12 and 24 weeks after intervention. RESULTS: Glycated hemoglobin at baseline was 10.34% (SE = 0.22%) and 8.54% (SE = 0.24%, p < 0.001) and 8.09% (SE = 0.21%, p < 0.001) at 12 and 24 weeks after intervention, respectively, with a significant reduction from baseline. CONCLUSIONS: More frequent medical visits, with treatment inputs including the use of insulin pens and self-monitoring, have improved glycemic control (reduction of 2.25% in HbA1C, on average, at 24 weeks of follow-up). Our data support a change in the management and medical behavior of older patients with chronically decompensated diabetes. PMID:29791677

Smoking behavior and motivation to quit among chronic pain patients initiating multidisciplinary pain treatment: a prospective study.

PubMed

Unrod, Marina; Gironda, Ronald J; Clark, Michael E; White, Kristi E; Simmons, Vani N; Sutton, Steven K; Brandon, Thomas H

2014-08-01

The primary aim of this study was to assess smoking characteristics and cessation motivation prior to and after initiation of multidisciplinary chronic pain treatment. A secondary aim was to identify predictors of cessation motivation among smokers initiating treatment for chronic pain. We used a prospective, nonrandomized, repeated measures design. The study was conducted in a multidisciplinary specialty pain treatment program at a veterans hospital. Smokers (N = 90) referred to a multidisciplinary pain program for the treatment of chronic pain. Patients completed questionnaires assessing pain-related and smoking-related factors prior to (baseline) and 8 weeks post (follow-up) specialty pain treatment initiation. Primary outcome measures were the Contemplation Ladder and the Stages of Change (SOC) algorithm. At baseline, patients reported moderate levels of cessation motivation, and 69% were in the contemplation stage or higher on the SOC. Motivation to quit smoking was higher at follow-up compared with baseline on both continuous, t(89) = 2.11, P < 0.05, and stage-based, z = 3.69, P < 0.01, measures. At follow-up, participants reported greater interest in receiving cessation interventions, and 7.8% of patients had quit smoking. Pain-related predictors of motivation (e.g., pain intensity) were subsumed by more general predictors (e.g., nicotine dependence). Patients in this sample were more motivated to quit smoking a few weeks after, as compared with before initiating specialty pain treatment. Future research into pain-specific predictors of cessation motivation is warranted to inform the development of interventions that address pain patients' unique needs. Wiley Periodicals, Inc.

Seven deadly sins in trauma outcomes research: an epidemiologic post mortem for major causes of bias.

PubMed

del Junco, Deborah J; Fox, Erin E; Camp, Elizabeth A; Rahbar, Mohammad H; Holcomb, John B

2013-07-01

Because randomized clinical trials in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multisystem responses to injury that necessitate highly dynamic treatment regimens such as blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Drawing on recent experience in the design, data collection, monitoring, and analysis of the 10-site observational PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, 7 common and sometimes overlapping biases are described through examples and resolution strategies. Sources of bias in trauma research include ignoring (1) variation in patients' indications for treatment (indication bias), (2) the dependency of intervention delivery on patient survival (survival bias), (3) time-varying treatment, (4) time-dependent confounding, (5) nonuniform intervention effects over time, (6) nonrandom missing data mechanisms, and (7) imperfectly defined variables. This list is not exhaustive. The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients.

A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors: Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT).

PubMed

Reinhardt, Martin; Brandmaier, Philipp; Seider, Daniel; Kolesnik, Marina; Jenniskens, Sjoerd; Sequeiros, Roberto Blanco; Eibisberger, Martin; Voglreiter, Philip; Flanagan, Ronan; Mariappan, Panchatcharam; Busse, Harald; Moche, Michael

2017-12-01

Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

PubMed

Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Conventional versus digital radiographs for intraoperative cervical spine-level localization: a prospective time and cost analysis.

PubMed

Steinmetz, Michael P; Mroz, Thomas E; Krishnaney, Ajit; Modic, Michael

2009-12-01

In today's health-care environment, operational efficiency is intrinsic to balancing the need for increased productivity driven by rising costs and potentially decreasing reimbursement. Other operational factors kept constant, decreasing the time for a procedure can be viewed as one marker for increased efficiency. To prospectively evaluate the time and operating room efficiency differences between the two methods for intraoperative level localization. STYDY DESIGN: Prospective nonrandomized study. Prospective consecutive patients undergoing a single-level anterior cervical discectomy and fusion (ACDF) with plate and allograft. Time for performance and interpretation of intraoperative localization radiograph. This is a prospective nonrandomized study of patients treated consecutively with a single-level ACDF with allograft and plating. All the patients underwent a conventional approach to the cervical spine. After exposure, a spinal needle was placed in the exposed intervertebral disc and a radiography was performed. Either a conventional or a digital radiography was used in each case. Eighteen patients were enrolled in this study. Ten patients underwent localization with conventional radiography, whereas eight patients underwent localization with digital imaging. The mean time for conventional radiography was 823 seconds (standard deviation [SD], 159), and for digital, it was 100 seconds (SD, 34; p<.001). Current technology provides options for level localization. Digital imaging provides equally accurate information as conventional radiography in a significantly reduced amount of time. Image quality, ease or archival, and manipulation provided by digital radiography are superior to those by provided fluoroscopy. Keeping operational factors constant, decreasing the time for a procedure, and increasing the efficiency of the environment may be viewed as a surrogate for improving the cost basis for a procedure.

Integration of a physical training program in a weight loss plan for overweight pet dogs.

PubMed

Vitger, Anne D; Stallknecht, Bente M; Nielsen, Dorte H; Bjornvad, Charlotte R

2016-01-15

To investigate whether a controlled physical training plan for overweight dogs during a weight loss program would improve cardiorespiratory fitness and better preserve lean body mass, compared with results for dogs undergoing a weight loss program based on caloric restriction alone. Prospective, nonrandomized clinical study. 19 client-owned overweight or obese dogs. All dogs were fed the same calorie-restricted diet rationed to achieve a weight loss rate of 1% to 2%/wk for 12 weeks. The fitness-and-diet (FD) group participated in a training program that included underwater and land-based treadmill exercise 3 times/wk. The diet-only (DO) group had no change in exercise routines. Daily activity before and during the intervention was recorded by accelerometry. Before and after intervention, heart rate during exercise was recorded to assess cardiovascular fitness, and body composition was analyzed by dual-energy x-ray absorptiometry. Differences between groups were evaluated with t tests and multiple regression analysis. Mean weight loss was 13.9% and 12.9% for the FD and DO groups, respectively (n = 8 dogs/group that completed the study). Mean accelerometer counts during intervention were 13% higher than baseline counts for the FD group. Heart rate during exercise declined after intervention in both groups. Lean body mass was preserved in the FD group and lost in the DO group during intervention. The controlled exercise plan used with a dietary weight loss program prevented loss of lean body mass in dogs. This finding supports inclusion of controlled physical training for obesity management in dogs.

Boosting restraint norms: a community-delivered campaign to promote booster seat use.

PubMed

Bryant-Stephens, Tyra; Garcia-Espana, J Felipe; Winston, Flaura K

2013-01-01

The objective of this study was to evaluate the effectiveness of a theoretically grounded community-delivered marketing campaign to promote belt-positioning booster seat (BPB) use among vulnerable populations when disseminated by community members. A prospective, nonrandomized community intervention trial was conducted to evaluate the "Boosting Restraint Norms" social marketing campaign delivered by community partners in Norristown, Pennsylvania (intervention community), between October 2008 and November 2008. York, Pennsylvania, served as the comparison community. In total, 800 vehicles with 822 children aged 4 to 7 years were observed for BPB use, the primary outcome of interest, at baseline (September 2008) and at 6 months after intervention (April 2009). During the study period, a 28 percent increase in the prevalence of BPB use at 6 months was observed in the intervention community with no change in the prevalence of BPB use in the comparison community. After adjustment for child age and gender, vehicle type, driver gender, and driver level, BPB use increased from 39 to 50 percent in the intervention community. The "Boosting Restraint Norms" social marketing campaign, distributed through community organizations combined with caregiver education and a one-time free distribution of BPBs, was effective in increasing BPB use. This study demonstrates the feasibility of utilizing community organizations with established audiences to spread the "No Regrets" messaging of the campaign in the community. This study also indicates that spreading evidence-based messages in this manner may effectively change behavior in populations that are often hard to reach. Future studies are needed in which this methodology is tested in additional communities and rural settings.

Gestalt Intervention Groups for Anxious Parents in Hong Kong: A Quasi-Experimental Design.

PubMed

Leung, Grace Suk Man; Khor, Su Hean

2017-01-01

This study examined the impact of gestalt intervention groups for anxious Chinese parents in Hong Kong. A non-randomized control group pre-test/post-test design was adopted. A total of 156 parents participated in the project. After 4 weeks of treatment, the intervention group participants had lower anxiety levels, less avoidance of inner experiences, and more kindness towards oneself and mindfulness when compared to control group participants. However, the dimension of self-judgment remained unchanged. The adaptation of gestalt intervention to suit the Chinese culture was discussed.

Against colorectal cancer in our neighborhoods (ACCION): A comprehensive community-wide colorectal cancer screening intervention for the uninsured in a predominantly Hispanic community.

PubMed

Shokar, Navkiran K; Byrd, Theresa; Salaiz, Rebekah; Flores, Silvia; Chaparro, Maria; Calderon-Mora, Jessica; Reininger, Belinda; Dwivedi, Alok

2016-10-01

Colorectal cancer (CRC) is the second leading cause of cancer deaths in the USA. Screening is widely recommended but underutilized, particularly among the low income, the uninsured, recent immigrants and Hispanics. The study objective was to determine the effectiveness of a comprehensive community-wide, bilingual, CRC screening intervention among uninsured predominantly Hispanic individuals. This prospective study was embedded in a CRC screening program and utilized a quasi-experimental design. Recruitment occurred from Community and clinic sites. Inclusion criteria were aged 50-75years, uninsured, due for CRC screening, Texas address and exclusions were a history of CRC, or recent rectal bleeding. Eligible subjects were randomized to either promotora (P), video (V), or combined promotora and video (PV) education, and also received no-cost screening with fecal immunochemical testing or colonoscopy and navigation. The non-randomly allocated controls recruited from a similar county, received no intervention. The main outcome was 6month self-reported CRC screening. Per protocol and worst case scenario analyses, and logistic regression with covariate adjustment were performed. 784 subjects (467 in intervention group, 317 controls) were recruited; mean age was 56.8years; 78.4% were female, 98.7% were Hispanic and 90.0% were born in Mexico. In the worst case scenario analysis (n=784) screening uptake was 80.5% in the intervention group and 17.0% in the control group [relative risk 4.73, 95% CI: 3.69-6.05, P<0.001]. No educational group differences were observed. Covariate adjustment did not significantly alter the effect. A multicomponent community-wide, bilingual, CRC screening intervention significantly increased CRC screening in an uninsured predominantly Hispanic population. Copyright © 2016 Elsevier Inc. All rights reserved.

Early crisis nontechnical skill teaching in residency leads to long-term skill retention and improved performance during crises: A prospective, nonrandomized controlled study.

PubMed

Doumouras, Aristithes G; Engels, Paul T

2017-07-01

Medical error is common in crises, and the majority of observed errors are nontechnical in nature. The long-term impact of teaching crisis nontechnical skills to residents has not been evaluated. The objective of this study was to determine the effect of simulation-based teaching of crisis nontechnical skills compared to controls one year after initial teaching. This was a prospective study using both historical controls and a before-and-after methodology to evaluate the effect of a high-fidelity simulation curriculum that used crisis resource management principles to teach nontechnical skills. Postgraduate year 2 and 3 residents were invited to take part in a prospective training course over 2 years. The primary outcome was leader performance evaluated by expert raters using the previously validated 7-point Ottawa Global Rating Scale. Overall, 23 residents performed 30 simulations over the 2 years with the intervention group of 7 residents being assessed in both years. After adjustment, the postgraduate year 3 intervention group who received training the previous year had significantly higher overall performance scores than all postgraduate year 2 scores (1.09 95% confidence interval 0.70-1.47, P < .001) and the historical postgraduate year 3 cohort who received no prior training (1.20, 95% confidence interval 0.37-2.03, P = .005). There was no decay of skills noted over the course of the study. Postgraduate year 3 residents who had prior training had significantly improved crisis performance compared to historical postgraduate year 3 controls and untrained postgraduate year 2 residents. There were no significant differences between the crisis performance of postgraduate year 2 residents and the untrained postgraduate year 3 controls. This confirms the beneficial effect and long-term retention after crisis nontechnical skill training. Copyright © 2016 Elsevier Inc. All rights reserved.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Assessing risk-adjustment approaches under non-random selection.

PubMed

Luft, Harold S; Dudley, R Adams

2004-01-01

Various approaches have been proposed to adjust for differences in enrollee risk in health plans. Because risk-selection strategies may have different effects on enrollment, we simulated three types of selection--dumping, skimming, and stinting. Concurrent diagnosis-based risk adjustment, and a hybrid using concurrent adjustment for about 8% of the cases and prospective adjustment for the rest, perform markedly better than prospective or demographic adjustments, both in terms of R2 and the extent to which plans experience unwarranted gains or losses. The simulation approach offers a valuable tool for analysts in assessing various risk-adjustment strategies under different selection situations.

Role of exercise training in polycystic ovary syndrome: a systematic review and meta-analysis.

PubMed

Benham, J L; Yamamoto, J M; Friedenreich, C M; Rabi, D M; Sigal, R J

2018-06-12

Preliminary evidence suggests exercise in polycystic ovary syndrome (PCOS) may improve reproductive and cardiometabolic parameters. Our primary aim was to determine the impact of exercise training on reproductive health in women with PCOS. Our secondary aim was to determine the effect of exercise training on cardiometabolic indices. A systematic review of published literature was conducted using MEDLINE and EMBASE based on a pre-published protocol (PROSPERO CRD42017065324). The search was not limited by year. Randomized controlled trials, non-randomized controlled trials and uncontrolled trials that evaluated an exercise intervention in women with PCOS and reported reproductive outcomes were included. Reproductive outcomes were analysed semi-quantitatively and a meta-analysis was conducted for reported cardiometabolic outcomes. Of 517 screened abstracts, 14 studies involving 617 women with PCOS were included: seven randomized controlled trials, one non-randomized controlled trial and six uncontrolled trials. There were insufficient published data to describe the effect of exercise interventions on ovulation quantitatively, but semi-quantitative analysis suggested that exercise interventions may improve menstrual regularity, pregnancy and ovulation rates. Our meta-analysis found that exercise improved lipid profiles and decreased waist circumference, systolic blood pressure and fasting insulin. The impact of exercise interventions on reproductive function remains unclear. However, our meta-analysis suggests that exercise interventions may improve cardiometabolic profiles in women with PCOS. © 2018 World Obesity Federation.

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

PubMed Central

2014-01-01

Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration Clinical trials.gov: NCT02160249 PMID:24996765

Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

PubMed

De Silva, Mary J; Breuer, Erica; Lee, Lucy; Asher, Laura; Chowdhary, Neerja; Lund, Crick; Patel, Vikram

2014-07-05

The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Clinical trials.gov: NCT02160249.

Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

PubMed

Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

2016-07-07

Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and psychosocial outcomes after prognostic genetic testing. We expect that empirical data from our study will give a scientific basis for medico-ethical considerations.

Translating the use of an enriched environment poststroke from bench to bedside: study design and protocol used to test the feasibility of environmental enrichment on stroke patients in rehabilitation.

PubMed

Janssen, H; Ada, L; Karayanidis, F; Drysdale, K; McElduff, P; Pollack, M; White, J; Nilsson, M; Bernhardt, J; Spratt, N J

2012-08-01

Environmental enrichment, a paradigm investigated extensively in animal models, is an intervention, which by design facilitates motor, sensory, social, and cognitive activity. It has been shown to improve poststroke motor and cognitive function in animal models of stroke. This is the first study to attempt to translate this intervention from the laboratory to the clinical setting. The overall aim of this pilot study is to test the feasibility of using environmental enrichment with stroke patients in a rehabilitation setting. The aim is to enrich the environment of stroke survivors in a rehabilitation ward and measure changes in their activity (physical, cognitive, and social activity). Prospective nonrandomized block design intervention study. In the control phase we will determine the change in activity levels of patients treated in a usual rehabilitation environment over time. In the intervention phase structured observational techniques (behavioural mapping) will be used to quantify the change in activity levels of patients exposed to environmental enrichment. The primary outcome is change in activity level. Additional data collected on entry to and exit from the study will include: cognitive function using a battery of cognitive tests, general function using the Functional Independence Measure, mood using the Patient Health Questionnaire 9 and boredom using the Stroke Rehabilitation Boredom Survey. Quality of life will be assessed using the Assessment of Quality of Life 1 month postdischarge from rehabilitation. Australian New Zealand Clinical Trials Registry# ACTRN12611000629932. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

Psychosocial stimulation interventions for children with severe acute malnutrition: a systematic review.

PubMed

Daniel, Allison I; Bandsma, Robert H; Lytvyn, Lyubov; Voskuijl, Wieger P; Potani, Isabel; van den Heuvel, Meta

2017-06-01

The WHO Guidelines for the inpatient treatment of severely malnourished children include a recommendation to provide sensory stimulation or play therapy for children with severe acute malnutrition (SAM). This systematic review was performed to synthesize evidence around this recommendation. Specifically, the objective was to answer the question: "In children with severe acute malnutrition, does psychosocial stimulation improve child developmental, nutritional, or other outcomes?" A review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO 2016: CRD42016036403). MEDLINE, Embase, CINAHL, and PsycINFO were searched with terms related to SAM and psychosocial stimulation. Studies were selected if they applied a stimulation intervention in children with SAM and child developmental and nutritional outcomes were assessed. Findings were presented within a narrative synthesis and a summary of findings table. Quality of the evidence was evaluated using the Cochrane risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Only two studies, both non-randomized controlled trials, met the selection criteria for this review. One was conducted in Jamaica (1975) with a follow-up period of 14 years; the other was done in Bangladesh (2002) with a six-month follow-up. At the individual study level, each of the included studies demonstrated significant differences in child development outcomes between intervention and control groups. Only the study conducted in Bangladesh demonstrated a clinically significant increase in weight-for-age z-scores in the intervention group compared to the control group. The evidence supporting the recommendation of psychosocial stimulation for children with SAM is not only sparse, but also of very low quality across important outcomes. High-quality trials are needed to determine the effects of psychosocial stimulation interventions on outcomes in children with SAM.

Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

PubMed

Storli, Kristian Eeg; Eide, Geir Egil

2016-01-01

Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

Systematic Review of Interventions to Reduce Urinary Tract Infection in Nursing Home Residents

PubMed Central

Meddings, Jennifer; Saint, Sanjay; Krein, Sarah L.; Gaies, Elissa; Reichert, Heidi; Hickner, Andrew; McNamara, Sara; Mann, Jason D.; Mody, Lona

2017-01-01

BACKGROUND Urinary tract infections (UTIs) in nursing homes are common, costly, and morbid. PURPOSE Systematic literature review of strategies to reduce UTIs in nursing home residents DATA SOURCES Ovid MEDLINE, Cochrane Library, CINAHL, Web of Science and Embase through June 22, 2015. STUDY SELECTION Interventional studies with a comparison group reporting at least one outcome for: catheter-associated UTI (CAUTI), UTIs not identified as catheter-associated, bacteriuria, or urinary catheter use. DATA EXTRACTION Two authors abstracted study design, participant and intervention details, outcomes, and quality measures. DATA SYNTHESIS Of 5,794 records retrieved, 20 records describing 19 interventions were included: 8 randomized controlled trials, 10 pre-post non-randomized interventions, and 1 non-randomized intervention with concurrent controls. Quality (range 8-25, median 15) and outcome definitions varied greatly. Thirteen studies employed strategies to reduce catheter use or improve catheter care; nine studies employed general infection prevention strategies (e.g., improving hand hygiene, surveillance, contact precautions, reducing antibiotics). The nineteen studies reported 12 UTI outcomes, 9 CAUTI outcomes, 4 bacteriuria outcomes, and 5 catheter use outcomes. Five studies showed CAUTI reduction (1 significantly); nine studies showed UTI reduction (none significantly); 2 studies showed bacteriuria reduction (none significantly). Four studies showed reduced catheter use (1 significantly). LIMITATIONS Studies were often underpowered to assess statistical significance; none were pooled given variety of interventions and outcomes. CONCLUSIONS Several practices, often implemented in bundles, appear to reduce UTI or CAUTI in nursing home residents such as improving hand hygiene, reducing and improving catheter use, managing incontinence without catheters, and enhanced barrier precautions. PMID:28459908

Systematic Review of Interventions to Reduce Urinary Tract Infection in Nursing Home Residents.

PubMed

Meddings, Jennifer; Saint, Sanjay; Krein, Sarah L; Gaies, Elissa; Reichert, Heidi; Hickner, Andrew; McNamara, Sara; Mann, Jason D; Mody, Lona

2017-05-01

Urinary tract infections (UTIs) in nursing homes are common, costly, and morbid. Systematic literature review of strategies to reduce UTIs in nursing home residents. Ovid MEDLINE, Cochrane Library, CINAHL, Web of Science and Embase through June 22, 2015. Interventional studies with a comparison group reporting at least 1 outcome for: catheter-associated UTI (CAUTI), UTIs not identified as catheter-associated, bacteriuria, or urinary catheter use. Two authors abstracted study design, participant and intervention details, outcomes, and quality measures. Of 5794 records retrieved, 20 records describing 19 interventions were included: 8 randomized controlled trials, 10 pre-post nonrandomized interventions, and 1 nonrandomized intervention with concurrent controls. Quality (range, 8-25; median, 15) and outcome definitions varied greatly. Thirteen studies employed strategies to reduce catheter use or improve catheter care; 9 studies employed general infection prevention strategies (eg, improving hand hygiene, surveillance, contact precautions, reducing antibiotics). The 19 studies reported 12 UTI outcomes, 9 CAUTI outcomes, 4 bacteriuria outcomes, and 5 catheter use outcomes. Five studies showed CAUTI reduction (1 significantly); 9 studies showed UTI reduction (none significantly); 2 studies showed bacteriuria reduction (none significantly). Four studies showed reduced catheter use (1 significantly). Studies were often underpowered to assess statistical significance; none were pooled given variety of interventions and outcomes. Several practices, often implemented in bundles, such as improving hand hygiene, reducing and improving catheter use, managing incontinence without catheters, and enhanced barrier precautions, appear to reduce UTI or CAUTI in nursing home residents. Journal of Hospital Medicine 2017;12:356-368. © 2017 Society of Hospital Medicine

Systematic review of stigma reducing interventions for African/Black diasporic women

PubMed Central

Loutfy, Mona; Tharao, Wangari; Logie, Carmen; Aden, Muna A; Chambers, Lori A; Wu, Wei; Abdelmaseh, Marym; Calzavara, Liviana

2015-01-01

Introduction Literature indicates that racism, sexism, homophobia and HIV-related stigma have adverse impacts on health, well-being, and quality of life among HIV-positive women of African descent (African/Black diaspora). However, limited evidence exists on the effectiveness of interventions aimed at reducing stigma tailored for these women. This study systematically reviewed randomized controlled trials (RCTs), non-randomized observational and quasi-experimental studies evaluating the effectiveness of interventions aimed at reducing stigma experienced by this population. Methods The Cochrane methodology was used to develop a search strategy in consultation with a librarian scientist. Databases searched included the Cochrane Library, Ovid EMBASE, PsycInfo, and 10 others. Two reviewers independently assessed the studies for potential relevance and conducted the Cochrane grading of RCTs to assess risk of bias and the Newcastle–Ottawa scale to assess the quality of non-randomized studies. Eligible papers were selected if they employed an intervention design with African/Black diasporic women living with HIV as the target population and had a primary outcome of stigma reduction. Results Of the five studies that met all of the eligibility criteria, four demonstrated the effectiveness of interventions in reducing HIV-related stigma. Only two of the five studies were designed specifically for HIV-positive African/Black diasporic women. Limitations included the absence of interventions addressing other forms of stigma and discrimination (e.g. gender discrimination, racism, heterosexism). Conclusions Our findings suggest that there are limited interventions designed to address multiple forms of stigma, including gender and racial discrimination, experienced by HIV-positive African/Black diasporic women. PMID:25862565

Systematic review of stigma reducing interventions for African/Black diasporic women.

PubMed

Loutfy, Mona; Tharao, Wangari; Logie, Carmen; Aden, Muna A; Chambers, Lori A; Wu, Wei; Abdelmaseh, Marym; Calzavara, Liviana

2015-01-01

Literature indicates that racism, sexism, homophobia and HIV-related stigma have adverse impacts on health, well-being, and quality of life among HIV-positive women of African descent (African/Black diaspora). However, limited evidence exists on the effectiveness of interventions aimed at reducing stigma tailored for these women. This study systematically reviewed randomized controlled trials (RCTs), non-randomized observational and quasi-experimental studies evaluating the effectiveness of interventions aimed at reducing stigma experienced by this population. The Cochrane methodology was used to develop a search strategy in consultation with a librarian scientist. Databases searched included the Cochrane Library, Ovid EMBASE, PsycInfo, and 10 others. Two reviewers independently assessed the studies for potential relevance and conducted the Cochrane grading of RCTs to assess risk of bias and the Newcastle-Ottawa scale to assess the quality of non-randomized studies. Eligible papers were selected if they employed an intervention design with African/Black diasporic women living with HIV as the target population and had a primary outcome of stigma reduction. Of the five studies that met all of the eligibility criteria, four demonstrated the effectiveness of interventions in reducing HIV-related stigma. Only two of the five studies were designed specifically for HIV-positive African/Black diasporic women. Limitations included the absence of interventions addressing other forms of stigma and discrimination (e.g. gender discrimination, racism, heterosexism). Our findings suggest that there are limited interventions designed to address multiple forms of stigma, including gender and racial discrimination, experienced by HIV-positive African/Black diasporic women.

The Effects of a Locally Developed mHealth Intervention on Delivery and Postnatal Care Utilization; A Prospective Controlled Evaluation among Health Centres in Ethiopia.

PubMed

Shiferaw, Solomon; Spigt, Mark; Tekie, Michael; Abdullah, Muna; Fantahun, Mesganaw; Dinant, Geert-Jan

2016-01-01

Although there are studies showing that mobile phone solutions can improve health service delivery outcomes in the developed world, there is little empirical evidence that demonstrates the impact of mHealth interventions on key maternal health outcomes in low income settings. A non-randomized controlled study was conducted in the Amhara region, Ethiopia in 10 health facilities (5 intervention, 5 control) together serving around 250,000 people. Health workers in the intervention group received an android phone (3 phones per facility) loaded with an application that sends reminders for scheduled visits during antenatal care (ANC), delivery and postnatal care (PNC), and educational messages on dangers signs and common complaints during pregnancy. The intervention was developed at Addis Ababa University in Ethiopia. Primary outcomes were the percentage of women who had at least 4 ANC visits, institutional delivery and PNC visits at the health center after 12 months of implementation of the intervention. Overall 933 and 1037 women were included in the cross-sectional surveys at baseline and at follow-up respectively. In addition, the medical records of 1224 women who had at least one antenatal care visit were followed in the longitudinal study. Women who had their ANC visit in the intervention health centers were significantly more likely to deliver their baby in the same health center compared to the control group (43.1% versus 28.4%; Adjusted Odds Ratio (AOR): 1.98 (95%CI 1.53-2.55)). A significantly higher percentage of women who had ANC in the intervention group had PNC in the same health center compared to the control health centers (41.2% versus 21.1%: AOR: 2.77 (95%CI 2.12-3.61)). Our findings demonstrated that a locally customized mHealth application during ANC can significantly improve delivery and postnatal care service utilization possibly through positively influencing the behavior of health workers and their clients.

Outcomes of Percutaneous Coronary Interventions for Chronic Total Occlusion Performed by Highly Experienced Japanese Specialists: The First Report From the Japanese CTO-PCI Expert Registry.

PubMed

Suzuki, Yoriyasu; Tsuchikane, Etsuo; Katoh, Osamu; Muramatsu, Toshiya; Muto, Makoto; Kishi, Koichi; Hamazaki, Yuji; Oikawa, Yuji; Kawasaki, Tomohiro; Okamura, Atsunori

2017-11-13

This report describes the registry and presents an initial analysis of outcomes for the different PCI approaches taken by the specialists. Strategies for percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) are complex. The Japanese Board of CTO Interventional Specialists has developed a prospective, nonrandomized registry of patients undergoing CTO-PCIs performed by 41 highly experienced Japanese specialists. Over the study period of January 2014 to December 2015, the registry included 2,846 consecutive CTO-PCI cases undertaken in Japan. The authors compared clinical outcomes between the different PCI approaches, following the intention-to-treat principle. The overall technical success rate of the procedures was 89.9%. The specialists frequently chose a retrograde approach as the primary CTO-PCI strategy (in 27.8% of cases). The technical success rate of the primary antegrade approach was significantly better than that of the primary retrograde approach (91.0% vs. 87.3%; p < 0.0001). The technical success rate decreased to 78.0% with the rescue retrograde approach. Parallel guidewire crossing and intravascular ultrasound-guided wire crossing were performed after guidewire escalation during antegrade CTO-PCI with a high technical success rate (75.0% to 88.9%). Severe lesion calcification was a strong predictor of failed CTO-PCI. CTO-PCI performed by highly experienced specialists achieved a high technical success rate. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A comparison of the in vivo neoendothelialization and wound healing processes of three atrial septal defect occluders used during childhood in a nonrandomized prospective trial

PubMed Central

Şahin, Derya Aydın; Başpınar, Osman; Sülü, Ayşe; Karslıgil, Tekin; Kul, Seval

2017-01-01

Objective: We prospectively investigated the neoendothelialization of transcatheter secundum atrial septal defect (ASD) closure in children receiving one of three different occluders. Methods: Transcatheter ASD closure was performed for 44 children. The patients were divided into three groups: group I: Amplatzer, group II: Lifetech CeraFlex, and group III: Occlutech Figulla Flex II septal occluder. The data were prospectively analyzed. Markers of the three phases of wound healing were studied in all patients before and on the 1st and 10th days and 1st month post intervention. Results: The mean age of children was 7.08±3.51 years, and the mean weight was 26.07±15.07 kg. The mean ASD diameter was 12.65±3.50 mm. Groups I, II, and III comprised 34.1%, 31.8%, and 34.1% patients, respectively. No significant differences were observed between the groups regarding patient number, age, defect size, device diameter, or total septum/device ratio (p>0.05). Inflammatory and proliferative phase marker levels increased following the procedure (p<0.05). However, scar formation markers did not change after 1 month. No significant differences in neoendothelializaton were observed among the different occluders (p>0.05). Conclusion: All three devices were composed of nitinol with different surface coating techniques. Although the different manufacturing features were claimed to facilitate of neoendothelialization, no differences were observed among the three devices 1 month following the procedure. PMID:28761023

Fissurectomy Combined with High-Dose Botulinum Toxin Is a Safe and Effective Treatment for Chronic Anal Fissure and a Promising Alternative to Surgical Sphincterotomy.

PubMed

Barnes, Thomas G; Zafrani, Zakhi; Abdelrazeq, Ayman S

2015-10-01

There is paucity of data on the long-term outcome of the combination of fissurectomy and botulinum toxin A injection for the management of chronic anal fissure. The aim of this study is to assess the safety, efficacy, and long-term outcome of the combination of fissurectomy and botulinum toxin A injection. This is a nonrandomized prospective cohort study. This study was conducted at a district general hospital in the United Kingdom. The cohort included all patients treated with fissurectomy and botulinum toxin A for chronic anal fissure between September 2008 and March 2012. The patients were treated with a combination of fissurectomy and botulinum toxin A injection. Symptomatic relief, fissure healing, complications, recurrence, and the need for further surgical intervention. One hundred and two patients received fissurectomy and botulinum toxin A injection for chronic anal fissure. At 12-week follow-up, 68 patients had resolution of symptoms and complete healing of chronic anal fissure, 29 patients had improvement of symptoms but incomplete healing and had further topical or botulinum toxin A treatment with subsequent complete healing. Ninety-five patients (93%) reported no postoperative complications. Seven patients reported a degree of incontinence in the immediate postoperative period. All reported normal continence at12-week follow-up. No local complications were observed or reported. At the mean follow-up of 33 months, there was no evidence of recurrence. Twelve-month follow-up was conducted via telephone interview only. This study is nonrandomized and did not examine the dose response of Botulinum Toxin A. Fissurectomy combined with high-dose botulinum toxin A is a safe, effective, and durable option for the management of chronic anal fissure and a promising alternative to surgical sphincterotomy.

Effects of a settings-based intervention to promote student wellbeing and reduce smoking in vocational schools: A non-randomized controlled study.

PubMed

Andersen, Susan; Rod, Morten Hulvej; Ersbøll, Annette Kjær; Stock, Christiane; Johansen, Christoffer; Holmberg, Teresa; Zinckernagel, Line; Ingholt, Liselotte; Sørensen, Betina Bang; Tolstrup, Janne Schurmann

2016-07-01

School dropout and health risk behavior such as cigarette smoking represent major problems among students attending upper secondary vocational education. Modifications to the social environment may promote educational attainment as well as health and wellbeing of young people. However, there is a need for more evidence-based intervention programs. The aim of this study was to assess the effectiveness of an intervention targeting the socio-environmental setting at vocational schools on student wellbeing and smoking. We conducted a non-randomized controlled trial of 5794 students (mean age 21 years; 81% male) in 10 (four intervention and six comparison) large vocational schools in Denmark. The intervention involved changes in everyday school practices focusing on four themes: (i) introduction activities, (ii) daily class meetings, (iii) scheduled breaks and (iv) pleasant non-smoking environment. Outcomes were student wellbeing (four subscales: school connectedness, student support, teacher relatedness, positive valuing of the profession) and daily smoking measured at 10-week follow-up. We found statistically significant between-group difference in school connectedness, but not in student support, teacher relatedness and valuing the profession. The intervention had no effect on daily smoking. However, we found a statistically significant interaction between baseline smoking status and condition. This interaction suggested that baseline occasional smokers in the intervention group had significantly reduced odds ratio (OR) of becoming a daily smoker compared to baseline occasional smokers in the control group (8% versus 16%; OR = 0.44). The positive effects on school connectedness and in preventing occasional smokers becoming daily smokers indicate that it is possible to tackle school-related wellbeing and smoking in a high risk population through settings-based interventions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Reducing Threats to Validity by Design in a Nonrandomized Experiment of a School-Wide Prevention Model

ERIC Educational Resources Information Center

Sørlie, Mari-Anne; Ogden, Terje

2014-01-01

This paper reviews literature on the rationale, challenges, and recommendations for choosing a nonequivalent comparison (NEC) group design when evaluating intervention effects. After reviewing frequently addressed threats to validity, the paper describes recommendations for strengthening the research design and how the recommendations were…

Empirically Driven Variable Selection for the Estimation of Causal Effects with Observational Data

ERIC Educational Resources Information Center

Keller, Bryan; Chen, Jianshen

2016-01-01

Observational studies are common in educational research, where subjects self-select or are otherwise non-randomly assigned to different interventions (e.g., educational programs, grade retention, special education). Unbiased estimation of a causal effect with observational data depends crucially on the assumption of ignorability, which specifies…

Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results.

PubMed

Yadav, Raj Kumar; Magan, Dipti; Mehta, Nalin; Sharma, Ratna; Mahapatra, Sushil Chandra

2012-07-01

Previously it was shown that a brief yoga-based lifestyle intervention was efficacious in reducing oxidative stress and risk of chronic diseases even in a short duration. The objective of this study was to assess the efficacy of this intervention in reducing stress and inflammation in patients with chronic inflammatory diseases. This study reports preliminary results from a nonrandomized prospective ongoing study with pre-post design. The study was conducted at the Integral Health Clinic, an outpatient facility conducting these yoga-based lifestyle intervention programs for prevention and management of chronic diseases. Patients with chronic inflammatory diseases and overweight/obese subjects were included while physically challenged, and those on other interventions were excluded from the study. A pretested intervention program included asanas (postures), pranayama (breathing exercises), stress management, group discussions, lectures, and individualized advice. There was a reduction in stress (plasma cortisol and β-endorphin) and inflammation (interleukin [IL]-6 and tumor necrosis factor [TNF]-α) at day 0 versus day 10. Eighty-six (86) patients (44 female, 42 male, 40.07 ± 13.91 years) attended this program. Overall, the mean level of cortisol decreased from baseline to day 10 (149.95 ± 46.07, 129.07 ± 33.30 ng/mL; p=0.001) while β-endorphins increased from baseline to day 10 (3.53 ± 0.88, 4.06 ± 0.79 ng/mL; p=0.024). Also, there was reduction from baseline to day 10 in mean levels of IL-6 (2.16 ± 0.42, 1.94 ± 0.10 pg/mL, p=0.036) and TNF-α (2.85 ± 0.59, 1.95 ± 0.32 pg/mL, p=0.002). This brief yoga-based lifestyle intervention reduced the markers of stress and inflammation as early as 10 days in patients with chronic diseases; however, complete results of this study will confirm whether this program has utility as complementary and alternative therapy.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

International, prospective haemovigilance study on methylene blue-treated plasma.

PubMed

Noens, L; Vilariño, Ma D; Megalou, A; Qureshi, H

2017-05-01

Methylene blue is a phenothiazine dye, which in combination with visible light has virucidal and bactericidal properties, disrupting the replication of a broad range of enveloped viruses and some non-enveloped viruses. The study objective was to collect data on adverse reactions occurring with methylene blue plasma administered in a routine clinical practice environment and document their characteristics and severity. This was an open label, multicentre, non-controlled, non-randomized, non-interventional study. Patients who receive a methylene blue plasma transfusion were observed for any signs and symptoms (adverse reactions) within 24 h safter the start of the transfusion, in different hospitals for a study duration of at least 1 year. A total of 19 315 methylene blue plasma units were transfused. There were eight patients with adverse reactions recorded during the study, one of them serious. Two had more than one reaction (two and four, respectively). Three patients had previous transfusions with methylene blue plasma only. Methylene blue plasma has a very acceptable safety profile with a rate of serious adverse reactions of 0·5/10 000 units. © 2017 International Society of Blood Transfusion.

A systematic review of yoga for state anxiety: considerations for occupational therapy.

PubMed

Chugh-Gupta, Neha; Baldassarre, Fulvia G; Vrkljan, Brenda H

2013-06-01

State anxiety can result from a variety of life situations. This type of anxiety can disrupt occupational engagement and performance, thereby affecting rehabilitation and recovery. Occupational therapists need to address the connection between mind-body-spirit and its relationship to performance and engagement in meaningful occupations. Yoga, when used as an adjunct to therapy, has the potential to address state anxiety. The aim was to systematically review the evidence concerning the effectiveness of yoga as a treatment approach for state anxiety. Six electronic databases, the authors' own files, and the references of included studies from 1990 to July 2011 were searched. A total of 25 unique studies represented by 26 publications made up the sample: two systematic reviews; 16 randomized controlled trials, and seven prospective, controlled, non-randomized studies. Evidence suggests yoga can be a viable therapeutic option for reducing state anxiety in certain situations. In making the determination to recommend yoga as an intervention, occupational therapists should consider the client's circumstances and values as well as the type and intensity of the yoga program.

The usefulness of lean six sigma to the development of a clinical pathway for hip fractures.

PubMed

Niemeijer, Gerard C; Flikweert, Elvira; Trip, Albert; Does, Ronald J M M; Ahaus, Kees T B; Boot, Anja F; Wendt, Klaus W

2013-10-01

The objective of this study was to show the usefulness of lean six sigma (LSS) for the development of a multidisciplinary clinical pathway. A single centre, both retrospective and prospective, non-randomized controlled study design was used to identify the variables of a prolonged length of stay (LOS) for hip fractures in the elderly and to measure the effect of the process improvements--with the aim of improving efficiency of care and reducing the LOS. The project identified several variables influencing LOS, and interventions were designed to improve the process of care. Significant results were achieved by reducing both the average LOS by 4.2 days (-31%) and the average duration of surgery by 57 minutes (-36%). The average LOS of patients discharged to a nursing home reduced by 4.4 days. The findings of this study show a successful application of LSS methodology within the development of a clinical pathway. Further research is needed to explore the effect of the use of LSS methodology at clinical outcome and quality of life. © 2012 John Wiley & Sons Ltd.

The impact of group counseling on depression, post-traumatic stress and function outcomes: a prospective comparison study in the Peter C. Alderman trauma clinics in northern Uganda.

PubMed

Nakimuli-Mpungu, Etheldreda; Okello, James; Kinyanda, Eugene; Alderman, Stephen; Nakku, Juliet; Alderman, Jeffrey S; Pavia, Alison; Adaku, Alex; Allden, Kathleen; Musisi, Seggane

2013-10-01

The effectiveness of group interventions for adults with mental distress in post-conflict settings is less clear in sub-Saharan Africa. To assess the impact of group counseling intervention on depression, post-traumatic stress and function outcomes among adults attending the Peter C. Alderman Foundation (PCAF) trauma clinics in northern Uganda. 631 War affected adults were enrolled into PCAF trauma clinics. Using a quasi-experimental design, assessments were conducted at baseline, at 3 and 6 months following initiation of care. Multivariate longitudinal regression models were used to determine change in depression, post-traumatic stress and function scores over time among group counseling participants and non-participants. In comparison to non-participants, participants had faster reduction in depression scores during the 6-month follow-up period [β=-1.84, 95%CI (-3.38 to -0.30), p=0.019] and faster reduction in post-traumatic stress scores during the 3-month follow-up period [β=-2.14, 95%CI (-4.21 to -0.10), p=0.042]. At 3-month follow up, participants who attended two or more sessions had faster increase in function scores [β=3.51, 95%CI (0.61-6.40), p=0.018] than participants who attended only one session. Selection bias due to the use of non-random samples. Substantial attrition rates and small sample sizes may have resulted in insufficient statistical power to determine meaningful differences. The group counseling intervention offered in the PCAF clinics may have considerable mental health benefits over time. There is need for more research to structure, standardize and test the efficacy of this intervention using a randomized controlled trial. © 2013 Elsevier B.V. All rights reserved.

Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

PubMed

Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

2016-01-30

This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. Copyright © 2016. Published by Elsevier Ireland Ltd.

Comparative evaluation of the content and structure of communication using two handoff tools: implications for patient safety.

PubMed

Abraham, Joanna; Kannampallil, Thomas G; Almoosa, Khalid F; Patel, Bela; Patel, Vimla L

2014-04-01

Handoffs vary in their structure and content, raising concerns regarding standardization. We conducted a comparative evaluation of the nature and patterns of communication on 2 functionally similar but conceptually different handoff tools: Subjective, Objective, Assessment and Plan, based on a patient problem-based format, and Handoff Intervention Tool (HAND-IT), based on a body system-based format. A nonrandomized pre-post prospective intervention study supported by audio recordings and observations of 82 resident handoffs was conducted in a medical intensive care unit. Qualitative analysis was complemented with exploratory sequential pattern analysis techniques to capture the characteristics and types of communication events (CEs) and breakdowns. Use of HAND-IT led to fewer communication breakdowns (F1,80 = 45.66: P < .0001), greater number of CEs (t40 = 4.56; P < .001), with more ideal CEs than Subjective, Objective, Assessment and Plan (t40 = 9.27; P < .001). In addition, the use of HAND-IT was characterized by more request-response CE transitions. The HAND-IT's body system-based structure afforded physicians the ability to better organize and comprehend patient information and led to an interactive and streamlined communication, with limited external input. Our results also emphasize the importance of information organization using a medical knowledge hierarchical format for fostering effective communication. Copyright © 2014 Elsevier Inc. All rights reserved.

Alternative approaches for studying humanitarian interventions: propensity score methods to evaluate reintegration packages impact on depression, PTSD, and function impairment among child soldiers in Nepal.

PubMed

Kohrt, B A; Burkey, M; Stuart, E A; Koirala, S

2015-01-01

Ethical, logistical, and funding approaches preclude conducting randomized control trials (RCTs) in some humanitarian crises. A lack of RCTs and other intervention research has contributed to a limited evidence-base for mental health and psychosocial support (MHPS) programs after disasters, war, and disease outbreaks. Propensity score methods (PSMs) are an alternative analysis technique with potential application for evaluating MHPS programs in humanitarian emergencies. PSMs were used to evaluate impacts of education reintegration packages (ERPs) and other (vocational or economic) reintegration packages (ORPs) v. no reintegration programs on mental health of child soldiers. Propensity scores were used to determine weighting of child soldiers in each of the three treatment arms. Multiple linear regression was used to estimate adjusted changes in symptom score severity on culturally validated measures of depression, post-traumatic stress disorder (PTSD), and functional impairment from baseline to 1-year follow-up. Among 258 Nepali child soldiers participating in reintegration programs, 54.7% completed ERP and 22.9% completed ORP. There was a non-significant reduction in depression by 0.59 (95% CI -1.97 to 0.70) for ERP and by 0.60 (95% CI -2.16 to 0.96) for ORP compared with no treatment. There were non-significant increases in PTSD (1.15, 95% CI -1.55 to 3.86) and functional impairment (0.91, 95% CI -0.31 to 2.14) associated with ERP and similar findings for ORP (PTSD: 0.66, 95% CI -2.24 to 3.57; functional impairment (1.05, 95% CI -0.71 to 2.80). In a humanitarian crisis in which a non-randomized intervention assignment protocol was employed, the statistical technique of PSMs addressed differences in covariate distribution between child soldiers who received different integration packages. Our analysis did not demonstrate significant changes in psychosocial outcomes for ERPs and ORPs. We suggest the use of PSMs in evaluating non-randomized interventions in humanitarian crises when non-randomized conditions are not utilized.

Will X-ray Safety Glasses Become Mandatory for Radiological Vascular Interventions?

PubMed

Thomas, Rohit Philip; Grau, Mathias; Eldergash, Osama; Kowald, Tobias; Schnabel, Johannes; Szczechowicz, Marcin; Chavan, Ajay

2018-07-01

The annual permissible radiation ocular lens dose has been reduced to 20 millisieverts (mSv) in the current European directive 2013/59/Euratom. The aim of this study was to evaluate the personal radiation dose for vascular interventions with special focus on ocular lens dose. From May 2016 to October 2016, the personal radiation doses of two interventionists and four technicians were prospectively recorded during 206 vascular interventions. The position of personnel, intervention type and fluoroscopy time were recorded. Parameters evaluated were total body dose measured by film dosimeter, hand dose measured by ring thermoluminescent dosimeter (TLD) and ocular lens dose measured by TLD placed in front of the safety glasses. Linear regression analysis was used to estimate the dose at 2 and 5 years. The ocular lens dose, hand and total body dose of the two interventionists were 11/5, 56/47 and 0.6 mSv each, respectively. The estimated 5-year ocular dose was 113.08 mSv (95% CI 38.2-187.97)/40.95 (95% CI 16.9-64.7). Similarly, hand dose was 608.4 mSv (95% CI 442.78-774.38)/514.47 (95% CI 329.83-699.10) and body dose 6.07 mSv (95% CI 4.70-8.22)/5.12 (95% CI 3.65-6.59), respectively. Amongst four technicians, only the first assistant showed recordings of 0.3 mSv body dose, 2 mSv ocular lens dose and 5 mSv hand dose. The yearly ocular lens dose, particularly for interventionists dealing with complex interventions, could cross the permitted yearly limit set by the new Euratom directive. Therefore, X-ray safety glasses would become mandatory for complex radiological vascular interventions. Level III, non-randomized controlled cohort/follow-up study.

Is the Use of a Support Bridge Beneficial for Preventing Stomal Retraction After Loop Ileostomy? A Prospective Nonrandomized Study.

PubMed

Oh, Heung-Kwon; Han, Eon Chul; Song, Yoon Suk; Seo, Mi Sun; Ryoo, Seung-Bum; Jeong, Seung-Yong; Park, Kyu Joo

2015-01-01

A temporary defunctioning loop ileostomy is frequently created during low colorectal or coloanal anastomosis to prevent peritoneal sepsis associated with anastomotic leakage. We investigated whether routine support bridge placement prevents stoma retraction after the formation of a loop ileostomy. Prospective, nonrandomized trial. The study sample comprised 32 consecutive patients who underwent defunctioning loop ileostomy at an academic tertiary care center in Seoul Korea from February to September 2010. Patients were nonrandomly allocated to "no bridge," "short-term bridge" (1 week), and "long-term bridge" (3 weeks) groups based on the surgeon's clinical judgment. Group differences in stoma height changes over time were analyzed. Subjects' mean age was 59.5 (range: 43-82) years, and the male-to-female ratio was 2.2:1.0. The mean heights of the stoma on postoperative day 2 and postoperative month 3, respectively, were 1.07 ± 0.16 cm (mean ± SD) and 0.81 ± 0.17 cm in the no-bridge group, 1.70 ± 0.29 cm and 1.21 ± 0.18 cm in the short-term bridge group, and 1.18 ± 0.16 cm and 1.01 ± 0.20 cm in the long-term bridge group. The changes in the stoma height 3 months after the surgery showed no statistically significant differences among the groups (P = .430). Stoma Quality of Life scores at 3 weeks (47.4 vs 46.1; P = .730) were similar for patients with and without bridges. However, a significantly greater number of patients with bridges reported difficulty with pouch changes compared to those without bridges (72.7% vs 14.3%; P = .002). Routine use of support bridges during loop ileostomy is unnecessary and inconvenient to patients. If a support bridge must be used, it can be removed early.

The Effectiveness of a New Model in Managing Pregnant Women with Iron Deficiency Anemia in Indonesia: A Nonrandomized Controlled Intervention Study.

PubMed

Widyawati, Widyawati; Jans, Suze; Bor, Hans H J; van Dillen, Jeroen; Lagro-Janssen, Antoine L M

2015-12-01

Indonesia has a major problem with iron deficiency anemia among pregnant women. A new model named the Four Pillars Approach was designed to improve antenatal care for these women. This study aimed to measure the effectiveness of the model in managing pregnant women with iron deficiency anemia. We used a nonrandomized controlled intervention study. The study, with the Four Pillars Approach as intervention versus usual care as its control, was conducted in two provinces in Java (Indonesia) during the period from March 2012 until May 2013. Main outcome measures were a difference of Hb level ≥ 0.5 g/dL, the number of women who attended five or more antenatal care visits, and birthing with a skilled birth attendant. Three hundred fifty-four participants were enrolled in the study. Participants in the intervention group had an adjusted odds ratio of 25.0 (95% CI 12.03-52.03, p = 0.001) for increased hemoglobin of ≥ 0.5 g/dL at 35-37 weeks of gestation, compared with the control group. In the intervention group, 95.0 percent of women had five or more antenatal care visits, compared with 57.2 percent (p = 0.001) in the control group. All births in both groups were assisted by skilled birth attendants. The Four Pillars Approach is effective in increasing the hemoglobin level and the frequency of antenatal care visits of participants when compared with the usual care for pregnant women with anemia. © 2015 Wiley Periodicals, Inc.

A systematic review of exercise and psychosocial rehabilitation interventions to improve health-related outcomes in patients with bladder cancer undergoing radical cystectomy.

PubMed

Rammant, Elke; Decaestecker, Karel; Bultijnck, Renée; Sundahl, Nora; Ost, Piet; Pauwels, Nele S; Deforche, Benedicte; Pieters, Ronny; Fonteyne, Valérie

2018-05-01

Summarizing the evidence on the effects of pre- and postoperative exercise and psychosocial rehabilitation interventions on patient-reported outcomes (PROs) and physical fitness in bladder cancer patients undergoing radical cystectomy. The Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science and the Physiotherapy Evidence Database were searched independently by two authors from inception until 10 November 2017. Cited references of the studies and citing references retrieved via Web of Science were also checked. Randomized controlled trials (RCTs) and non-randomized studies assessing effects of exercise and psychosocial interventions in bladder cancer patients undergoing radical cystectomy were eligible. Primary outcome measures were PROs and physical fitness. Risk of bias was assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Scale. Five RCTs (three exercise and two psychosocial studies) and one non-randomized psychosocial study comprising 317 bladder cancer patients were included. Timing of the intervention was preoperative ( n = 2), postoperative ( n = 2) or both pre- and postoperative ( n = 2). Positive effects of exercise were found for physical fitness ( n = 3), some health-related quality-of-life (HRQoL) domains ( n = 2), personal activities in daily living ( n = 1) and muscle strength ( n = 1). Psychosocial interventions showed positive effects on anxiety ( n = 1), fatigue ( n = 1), depression ( n = 1), HRQoL ( n = 1) and posttraumatic growth ( n = 1). Quality assessment showed most shortcomings with sample sizes and strong heterogeneity was observed between studies. The evidence relating to the effects of exercise in bladder cancer is very limited and is even less for psychosocial interventions.

Treatment of substance use disorders in schizophrenia.

PubMed

Bennett, Melanie E; Bradshaw, Kristen R; Catalano, Lauren T

2017-07-01

Substance use disorders (SUDs) represent a great barrier to functional recovery for individuals with schizophrenia. It is important to use research on treatment of SUDs in schizophrenia to guide treatment recommendations and program planning. We review studies of pharmacological and psychosocial interventions to treat SUDs in individuals with schizophrenia. The criteria used to select studies for inclusion are (1) the percentage of the sample with a schizophrenia spectrum diagnosis is at least 25%; (2) participants have a comorbid SUD or problem use of substances; (3) an intervention for SUD is provided; (4) a substance use-related outcome is measured; and (5) the study design enabled examination of pre-post outcome measures including open label trials, nonrandomized evaluations (quasi-experimental designs, nonrandom assignment to groups), or randomized controlled trials. There are few psychopharmacology outcomes studies. Most have examined use of antipsychotic medications to treat SUDs in schizophrenia. Several trials have yielded positive findings for naltrexone in reducing drinking compared to placebo in this population. Motivational and cognitive-behavioral interventions are associated with decreased substance use in several trials. Treatment for SUDs is feasible within a range of settings and acceptable to many individuals with schizophrenia. All individuals with schizophrenia should be offered brief or more extended psychosocial interventions that incorporate discussion of personal reasons to change and training in cognitive-behavioral strategies to reduce use, cope with cravings and stress, and avoid relapse. Future research must include larger samples, longitudinal designs, and similar outcome measures across studies.

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus-eluting bioresorbable scaffold in ST-segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY-IT study.

PubMed

Ielasi, Alfonso; Varricchio, Attilio; Campo, Gianluca; Leoncini, Massimo; Cortese, Bernardo; Vicinelli, Paolo; Brugaletta, Salvatore; di Uccio, Fortunato Scotto; Latib, Azeem; Tespili, Maurizio

2017-06-01

To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A Meta-Analysis of the Effects of Classroom Management Strategies and Classroom Management Programs on Students' Academic, Behavioral, Emotional, and Motivational Outcomes

ERIC Educational Resources Information Center

Korpershoek, Hanke; Harms, Truus; de Boer, Hester; van Kuijk, Mechteld; Doolaard, Simone

2016-01-01

This meta-analysis examined which classroom management strategies and programs enhanced students' academic, behavioral, social-emotional, and motivational outcomes in primary education. The analysis included 54 random and nonrandom controlled intervention studies published in the past decade (2003-2013). Results showed small but significant…

The Impact of Peer Effects on Student Outcomes in New York City Public Schools

ERIC Educational Resources Information Center

Zabel, Jeffrey E.

2008-01-01

The impact of peers on student outcomes has important policy implications for how students are organized into classes and the overall impact of education interventions. But it is difficult to accurately measure peer effects because of the nonrandom sorting of students and teachers into classrooms and the endogeneity of peers' achievement. In this…

NOSE laparoscopic gastrectomies for early gastric cancer may reduce morbidity and hospital stay: early results from a prospective nonrandomized study.

PubMed

Hüscher, Cristiano G S; Lirici, Marco Maria; Ponzano, Cecilia

2017-04-01

Natural orifice specimen extraction - NOSE laparoscopy is a promising technique that avoids mini-laparotomy, possibly reducing postoperative pain, wound infections and hospital stay. Recent systematic reviews have shown that postoperative morbidity associated with laparoscopically assisted gastrectomies is similar to that after open gastrectomies. More specifically, there is no difference in wound infection rate. The study objective was to evaluate whether postoperative morbidity and hospital stay may be reduced by transoral specimen extraction after laparoscopically assisted gastrectomy for early gastric cancer (EGC). A prospective, nonrandomized study was carried out starting in August 2012. Data from all patients operated on during the first year, with minimum 18 months follow-up, were collected to assess feasibility, oncologic results, postoperative morbidity, hospital stay and functional results. Overall, 14 patients were included and followed-up. After gastric resection, a 3 cm opening was created on the gastric stump, and the specimen, divided into three segments stitched one to each other, was sutured to the gastric tube and retrieved through the mouth. Postoperative morbidity was 7.14% (1/14): one case of pneumonia. No wound infection occurred. The mean postoperative hospital stay was 4.7 ± 1.0 days. NOSE laparoscopic subtotal gastrectomy is feasible and safe, with similar oncologic results as LAG, but decreased morbidity and hospital stay.

Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial.

PubMed

Murphy, Susan E; Blake, Catherine; Power, Camillus K; Fullen, Brona M

2016-04-01

A nonrandomized controlled trial. This study aims to explore the effectiveness of group-based stratified care in primary care. Stratified care based on psychosocial screening (STarT Back) has demonstrated greater clinical and cost-effectiveness in patients with low back pain. However, low back pain interventions are often delivered in groups and evaluating this system of care in a group setting is important. Patients were recruited from 60 general practices and linked physiotherapy services. A new group stratified intervention was compared with a historical nonstratified control group. Patients stratified as low, medium and high risk were offered risk-matched group care. Consenting participants completed self-report measures of functional disability (primary outcome measure), pain, psychological distress, and beliefs. The historical control received a generic group intervention. Analysis was by intention to treat. In total, 251 patients in the new stratified intervention and 332 in the historical control were included in the primary analysis at 12 weeks. The mean age of patients was 43 ± 10.98 years. Overall adjusted mean changes in the RMDQ scores were higher in the stratified intervention than in the control arm at 12-week follow-up (P = 0.028). Exploring the risk groups, individually the high-risk stratified group, demonstrated better outcome over the controls (P = 0.031). The medium-risk stratified intervention demonstrated equally good outcomes (P = 0.125), and low-risk stratified patients, despite less intervention, did as well as the historical controls (P = 0.993). Stratified care delivered in a group setting demonstrated superior outcomes in the high-risk patients, and equally good outcomes for the medium and low-risk groups. This model, embedded in primary care, provides an early and effective model of chronic disease management and adds another dimension to the utility of the STarT Back system of care. 2.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Quasi-Experimental Designs.

PubMed

Schweizer, Marin L; Braun, Barbara I; Milstone, Aaron M

2016-10-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt, nonrandomized interventions. Quasi-experimental studies can be categorized into 3 major types: interrupted time-series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship, including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. Infect Control Hosp Epidemiol 2016;1-6.

Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship – Quasi-Experimental Designs

PubMed Central

Schweizer, Marin L.; Braun, Barbara I.; Milstone, Aaron M.

2016-01-01

Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt non-randomized interventions. Quasi-experimental studies can be categorized into three major types: interrupted time series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. PMID:27267457

Vitamin D status and weight loss: a systematic review and meta-analysis of randomized and nonrandomized controlled weight-loss trials.

PubMed

Mallard, Simonette R; Howe, Anna S; Houghton, Lisa A

2016-10-01

Obesity is associated with lower concentrations of serum 25-hydroxyvitamin D; however, uncertainty exists as to the direction of causation. To date, meta-analyses of randomized controlled vitamin D-supplementation trials have shown no effect of raising circulating vitamin D on body weight, although several weight-loss-intervention trials have reported an increase in circulating vitamin D after weight reduction. We undertook a systematic review and meta-analysis of randomized and nonrandomized controlled trials to determine whether weight loss compared with weight maintenance leads to an increase in serum 25-hydroxyvitamin D. A systematic search for controlled weight-loss-intervention studies published up to 31 March 2016 was performed. Studies that included participants of any age with changes in adiposity and serum 25-hydroxyvitamin D as primary or secondary outcomes were considered eligible. We identified 4 randomized controlled trials (n = 2554) and 11 nonrandomized controlled trials (n = 917) for inclusion in the meta-analysis. Random assignment to weight loss compared with weight maintenance resulted in a greater increase in serum 25-hydroxyvitamin D with a mean difference of 3.11 nmol/L (95% CI: 1.38, 4.84 nmol/L) between groups, whereas a mean difference of 4.85 nmol/L (95% CI: 2.59, 7.12 nmol/L) was observed in nonrandomized trials. No evidence for a dose-response effect of weight loss on the change in serum 25-hydroxyvitamin D was shown overall. Our results indicate that vitamin D status may be marginally improved with weight loss in comparison with weight maintenance under similar conditions of supplemental vitamin D intake. Although additional studies in unsupplemented individuals are needed to confirm these findings, our results support the view that the association between obesity and lower serum 25-hydroxyvitamin D may be due to reversed causation with increased adiposity leading to suboptimal concentrations of circulating vitamin D. This trial was registered at www.crd.york.ac.uk/PROSPERO/ as CRD42015023836. © 2016 American Society for Nutrition.

Application of a nonrandomized stepped wedge design to evaluate an evidence-based quality improvement intervention: a proof of concept using simulated data on patient-centered medical homes.

PubMed

Huynh, Alexis K; Lee, Martin L; Farmer, Melissa M; Rubenstein, Lisa V

2016-10-21

Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method's analytic advantages and applying to a broader set of evaluations. To test the feasibility of a nonrandomized stepped wedge design, we developed simulated data on patient care experiences and on QII implementation that had the structures and features of the expected data from a planned QII. We then applied the design in anticipation of performing an actual QII evaluation. We used simulated data on 108,000 patients to model nonrandomized stepped wedge results from QII implementation across nine primary care sites over 12 quarters. The outcome we simulated was change in a single self-administered question on access to care used by Veterans Health Administration (VA), based in the United States, as part of its quarterly patient ratings of quality of care. Our main predictors were QII exposure and time. Based on study hypotheses, we assigned values of 4 to 11 % for improvement in access when sites were first exposed to implementation and 1 to 3 % improvement in each ensuing time period thereafter when sites continued with implementation. We included site-level (practice size) and respondent-level (gender, race/ethnicity) characteristics that might account for nonrandomized timing in site implementation of the QII. We analyzed the resulting data as a repeated cross-sectional model using HLM 7 with a three-level hierarchical data structure and an ordinal outcome. Levels in the data structure included patient ratings, timing of adoption of the QII, and primary care site. We were able to demonstrate a statistically significant improvement in adoption of the QII, as postulated in our simulation. The linear time trend while sites were in the control state was not significant, also as expected in the real life scenario of the example QII. We concluded that the nonrandomized stepped wedge design was feasible within the parameters of our planned QII with its data structure and content. Our statistical approach may be applicable to similar evaluations.

Inefficacy of Kinesio-Taping(®) on early postoperative pain after ACL reconstruction: Prospective comparative study.

PubMed

Laborie, M; Klouche, S; Herman, S; Gerometta, A; Lefevre, N; Bohu, Y

2015-12-01

Kinesio-Taping(®) (K-Tape) is used in sports traumatology with the aim of reducing pain and improving blood and lymph circulation. The main objective of the present study was to assess the efficacy of K-Tape on early postoperative pain after anterior cruciate ligament (ACL) reconstruction. The study hypothesis was that K-Tape significantly decreases pain. A prospective non-randomized comparative study was conducted in 2013-2014 and included all patients who underwent primary ACL reconstruction by hamstring graft. Analgesia was standardized. Two groups, "K-Tape" and "controls", were formed according to the days on which the study physiotherapist was present. The K-Tape compression/decompression assembly was applied immediately postoperatively and maintained for 3days. Patients filled out online questionnaires. The main assessment criterion was mean postoperative pain (D0-D3) on a 0-to-10 scale. Secondary criteria were analgesia intake on the three WHO levels, awakening during the night of D0 due to pain, signs of postoperative discomfort, and patient satisfaction. Sixty patients (30 per group) were included, 57 of whom could be assessed: 28 K-Tape, 29 controls; 44 male, 13 female; mean age, 30.9±8.9 years. At inclusion, the two groups were comparable. There was no significant difference in mean (D0-D3) knee pain intensity: 3.8±2.2 for K-Tape, and 3.9±2 for controls (P=0.93). Analysis of variance (ANOVA) found no significant intergroup difference in evolution of pain (P=0.34). There were no other significant differences on the other assessment criteria. K-Tape showed no efficacy on early postoperative pain following ACL reconstruction. III; prospective non-randomized comparative study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Adiponectin, interleukin-6, and cardiovascular disease risk factors are modified by a short-term yoga-based lifestyle intervention in overweight and obese men.

PubMed

Sarvottam, Kumar; Magan, Dipti; Yadav, Raj Kumar; Mehta, Nalin; Mahapatra, Sushil C

2013-05-01

To investigate the effect of a short-term yoga-based lifestyle intervention on risk factors for cardiovascular disease (CVD) and markers of inflammation and endothelial function in overweight and obese men. Nonrandomized prospective lifestyle intervention study with pre-post design. SETTING AND LOCATION: Integral Health Clinic, an outpatient facility providing yoga-based lifestyle intervention programs for prevention and management of chronic diseases. Overweight and obese men (n=51) were enrolled in the study. Subjects who were physically unable to participate and those participating in other interventions were excluded from the study. A pretested intervention program including asanas (physical postures), pranayama (breathing exercises), group discussions, lectures, and individualized advice. The primary outcome measure was weight loss, and the secondary outcome measures were clinical and laboratory correlates of CVD risk, levels of interleukin-6 (IL-6), adiponectin, and endothelin-1 (ET-1). Men (n=51, body mass index [BMI] 26.26±2.42 kg/m(2)) were enrolled and underwent a yoga-based lifestyle intervention for 10 days. Of 51 subjects, 30 completed the study. There was a significant reduction in weight from Baseline to Day 10 (74.60±7.98, 72.69±8.37 kg, p<0.001, respectively), BMI (26.26±2.42, 25.69±2.47 kg/m(2), p<0.001, respectively), and systolic BP (121.73±11.58, 116.73±9.00, p=0.042, respectively). There was a significant reduction in plasma IL-6 from Baseline to Day 10 (median 2.24 vs. 1.26 pg/mL, respectively, p=0.012). There was a significant increase in the plasma adiponectin from Baseline to Day 10 (median 4.95 vs. 6.26 μg/mL, respectively, p=0.014). Plasma ET-1 level remained unchanged. These findings suggest that even a short-term yoga-based lifestyle intervention may be an important modality to reduce the risk for CVD as indicated by weight loss, reduction in systolic blood pressure, an increase in adiponectin, and decrease in IL-6 in overweight and obese men.

The Effects of a Locally Developed mHealth Intervention on Delivery and Postnatal Care Utilization; A Prospective Controlled Evaluation among Health Centres in Ethiopia

PubMed Central

Shiferaw, Solomon; Spigt, Mark; Tekie, Michael; Abdullah, Muna; Fantahun, Mesganaw; Dinant, Geert-Jan

2016-01-01

Background Although there are studies showing that mobile phone solutions can improve health service delivery outcomes in the developed world, there is little empirical evidence that demonstrates the impact of mHealth interventions on key maternal health outcomes in low income settings. Methods A non-randomized controlled study was conducted in the Amhara region, Ethiopia in 10 health facilities (5 intervention, 5 control) together serving around 250,000 people. Health workers in the intervention group received an android phone (3 phones per facility) loaded with an application that sends reminders for scheduled visits during antenatal care (ANC), delivery and postnatal care (PNC), and educational messages on dangers signs and common complaints during pregnancy. The intervention was developed at Addis Ababa University in Ethiopia. Primary outcomes were the percentage of women who had at least 4 ANC visits, institutional delivery and PNC visits at the health center after 12 months of implementation of the intervention. Findings Overall 933 and 1037 women were included in the cross-sectional surveys at baseline and at follow-up respectively. In addition, the medical records of 1224 women who had at least one antenatal care visit were followed in the longitudinal study. Women who had their ANC visit in the intervention health centers were significantly more likely to deliver their baby in the same health center compared to the control group (43.1% versus 28.4%; Adjusted Odds Ratio (AOR): 1.98 (95%CI 1.53–2.55)). A significantly higher percentage of women who had ANC in the intervention group had PNC in the same health center compared to the control health centers (41.2% versus 21.1%: AOR: 2.77 (95%CI 2.12–3.61)). Conclusions Our findings demonstrated that a locally customized mHealth application during ANC can significantly improve delivery and postnatal care service utilization possibly through positively influencing the behavior of health workers and their clients. PMID:27383186

Cumulative cisplatin dose in concurrent chemoradiotherapy for head and neck cancer: A systematic review.

PubMed

Strojan, Primož; Vermorken, Jan B; Beitler, Jonathan J; Saba, Nabil F; Haigentz, Missak; Bossi, Paolo; Worden, Francis P; Langendijk, Johannes A; Eisbruch, Avraham; Mendenhall, William M; Lee, Anne W M; Harrison, Louis B; Bradford, Carol R; Smee, Robert; Silver, Carl E; Rinaldo, Alessandra; Ferlito, Alfio

2016-04-01

The optimal cumulative dose and timing of cisplatin administration in various concurrent chemoradiotherapy protocols for nonmetastatic head and neck squamous cell carcinoma (HNSCC) has not been determined. The absolute survival benefit at 5 years of concurrent chemoradiotherapy protocols versus radiotherapy alone observed in prospective randomized trials reporting on the use of cisplatin monochemotherapy for nonnasopharyngeal HNSCC was extracted. In the case of nonrandomized studies, the outcome results at 2 years were compared between groups of patients receiving different cumulative cisplatin doses. Eleven randomized trials and 7 nonrandomized studies were identified. In 6 definitive radiotherapy phase III trials, a statistically significant association (p = .027) between cumulative cisplatin dose, independent of the schedule, and overall survival benefit was observed for higher doses. Results support the conclusion that the cumulative dose of cisplatin in concurrent chemoradiation protocols for HNSCC has a significant positive correlation with survival. © 2015 Wiley Periodicals, Inc. Head Neck 38: E2151-E2158, 2016. © 2015 Wiley Periodicals, Inc.

Effectiveness and safety of wheelchair skills training program in improving the wheelchair skills capacity: a systematic review.

PubMed

Tu, Chun-Jing; Liu, Lin; Wang, Wei; Du, He-Ping; Wang, Yu-Ming; Xu, Yan-Bing; Li, Ping

2017-12-01

To comprehensively assess the effectiveness and safety of wheelchair skills training program in improving wheelchair skills capacity. PubMed, OVID, EBSCO, ScienceDirect, Web of Science, CINAHL, Cochrane Library, Google Scholar, and China Knowledge Resource Integrated Database were searched up to March 2017. Controlled clinical trials that compared a wheelchair skills training program with a control group that received other interventions and used the wheelchair skills test scores to evaluate wheelchair skills capacity were included. Two authors independently screened articles, extracted data, and assessed the methodological quality using the Cochrane risk-of-bias tool in randomized controlled trial (RCT) and methodological index for non-randomized studies. The data results of wheelchair skills test scores were extracted. Data from 455 individuals in 10 RCTs and from 140 participants in seven non-randomized studies were included for meta-analysis using Stata version 12.0 (Stata Corporation, College Station, TX, USA). In the short term (immediately to one week) post-intervention, relative to a control group, manual wheelchair skills training could increase the total wheelchair skills test scores by 13.26% in RCTs (95% confidence interval (CI), 6.19%-20.34%; P < 0.001) and by 23.44% in non-randomized studies (95% CI, 13.98%-32.90%; P < 0.001). Few adverse events occurred during training; however, compared with a control group, evidence was insufficient to support the effectiveness of powered wheelchair skills training and the long-term (3-12 months) advantage of manual wheelchair skills training ( P = 0.755). The limited evidence suggests that wheelchair skills training program is beneficial in the short term, but its long-term effects remain unclear.

Mind the Teachers! The Impact of Mindfulness Training on Self-Regulation and Classroom Performance in a Sample of German School Teachers

ERIC Educational Resources Information Center

Rupprecht, Silke; Paulus, Peter; Walach, Harald

2017-01-01

Teacher wellbeing and performance is affected by their ability to cope with the demands of the profession. This pilot nonrandomized, waitlist-controlled study investigated the impact of a mindfulness intervention (Mindfulness-Based Stress Reduction) on teachers' wellbeing, self-regulation ability and classroom performance applying a mixed-method…

Mind the Teachers! The Impact of Mindfulness Training on Self-Regulation and Classroom Performance in a Sample of German School Teachers

ERIC Educational Resources Information Center

Rupprecht, Silke; Paulu, Peter; Walach, Harald

2017-01-01

Teacher wellbeing and performance is affected by their ability to cope with the demands of the profession. This pilot non-randomized, waitlist-controlled study investigated the impact of a mindfulness intervention (Mindfulness-Based Stress Reduction) on teachers' wellbeing, self-regulation ability and classroom performance applying a mixed-method…

The Feasibility of Reducing Sitting Time in Overweight and Obese Older Adults

ERIC Educational Resources Information Center

Rosenberg, Dori E.; Gell, Nancy M.; Jones, Salene M. W.; Renz, Anne; Kerr, Jacqueline; Gardiner, Paul A.; Arterburn, David

2015-01-01

Background: Overweight and obese older adults have high sedentary time. We tested the feasibility and preliminary effects of a sedentary time reduction intervention among adults over age 60 with a body mass index over 27 kg/m2 using a nonrandomized one-arm design. Methods: Participants (N = 25, mean age = 71.4, mean body mass index = 34) completed…

Non-Randomized Studies as a Source of Complementary, Sequential or Replacement Evidence for Randomized Controlled Trials in Systematic Reviews on the Effects of Interventions

ERIC Educational Resources Information Center

Schünemann, Holger J.; Tugwell, Peter; Reeves, Barnaby C.; Akl, Elie A.; Santesso, Nancy; Spencer, Frederick A.; Shea, Beverley; Wells, George; Helfand, Mark

2013-01-01

The terms applicability, generalizability, external validity and transferability are related, sometimes used interchangeably and have in common that they lack a clear and consistent definition in the classic epidemiological literature. However, all of these terms generally describe one overarching theme: whether or not available research evidence…

An analysis of reasons for failed back surgery syndrome and partial results after different types of surgical lumbar nerve root decompression.

PubMed

Bokov, Andrey; Isrelov, Alexey; Skorodumov, Alexander; Aleynik, Alexander; Simonov, Alexander; Mlyavykh, Sergey

2011-01-01

Despite the evident progress in treating vertebral column degenerative diseases, the rate of a so-called "failed back surgery syndrome" associated with pain and disability remains relatively high. However, this term has an imprecise definition and includes several different morbid conditions following spinal surgery, not all of which directly illustrate the efficacy of the applied technology; furthermore, some of them could even be irrelevant. To evaluate and systematize the reasons for persistent pain syndromes following surgical nerve root decompression. Prospective, nonrandomized, cohort study of 138 consecutive patients with radicular pain syndromes, associated with nerve root compression caused by lumbar disc herniation, and resistant to conservative therapy for at least one month. The minimal period of follow-up was 18 months. Hospital outpatient department, Russian Federation Pre-operatively, patients were examined clinically, applying the visual analog scale (VAS), Oswestry Disability Index (ODI), magnetic resonance imaging (MRI), discography and computed tomography (CT). According to the disc herniation morphology and applied type of surgery, all participants were divided into the following groups: for those with disc extrusion or sequester, microdiscectomy was applied (n = 65); for those with disc protrusion, nucleoplasty was applied (n = 46); for those with disc extrusion, nucleoplasty was applied (n = 27). After surgery, participants were examined clinically and the VAS and ODI were applied. All those with permanent or temporary pain syndromes were examined applying MRI imaging, functional roentgenograms, and, to validate the cause of pain syndromes, different types of blocks were applied (facet joint blocks, paravertebral muscular blocks, transforaminal and caudal epidural blocks). Group 1 showed a considerable rate of pain syndromes related to tissue damage during the intervention; the rates of radicular pain caused by epidural scar and myofascial pain were 12.3% and 26.1% respectively. Facet joint pain was found in 23.1% of the cases. Group 2 showed a significant rate of facet joint pain (16.9%) despite the minimally invasive intervention. The specificity of Group 3 was the very high rate of unresolved or recurred nerve root compression (63.0%); in other words, in the majority of cases, the aim of the intervention was not achieved. The results of the applied intervention were considered clinically significant if 50% pain relief on the VAS and a 40% decrease in the ODI were achieved. This study is limited because of the loss of participants to follow-up and because it is nonrandomized; also it could be criticized because the dynamics of numeric scores were not provided. The results of our study show that an analysis of the reasons for failures and partial effects of applied interventions for nerve root decompression may help to understand better the efficacy of the interventions and could be helpful in improving surgical strategies, otherwise the validity of the conclusion could be limited because not all sources of residual pain illustrate the applied technology efficacy. In the majority of cases, the cause of the residual or recurrent pain can be identified, and this may open new possibilities to improve the condition of patients presenting with failed back surgery syndrome.

A systematic review of nonrandomized controlled trials on the curative effects of aquatic exercise

PubMed Central

Kamioka, Hiroharu; Tsutani, Kiichiro; Mutoh, Yoshiteru; Okuizum, Hiroyasu; Ohta, Miho; Handa, Shuichi; Okada, Shinpei; Kitayuguchi, Jun; Kamada, Masamitsu; Shiozawa, Nobuyoshi; Park, Sang-Jun; Honda, Takuya; Moriyama, Shoko

2011-01-01

Background: The objectives of this review were to integrate the evidence of curative effects through aquatic exercise and assess the quality of studies based on a review of nonrandomized controlled trials (nRCTs). Methods: Study design was a systematic review of nonrandomized controlled trials. Trials were eligible if they were nonrandomized clinical trials. Studies included one treatment group in which aquatic exercise was applied. We searched the following databases from 2000 up to July 20, 2009: MEDLINE via PubMed, CINAHL, and Ichushi-Web. Results: Twenty-one trials met all inclusion criteria. Languages included were English (N = 9), Japanese (N = 11), and Korean (N = 1). Target diseases were knee and/or hip osteoarthritis, poliomyelitis, chronic kidney disease, discomforts of pregnancy, cardiovascular diseases, and rotator cuff tears. Many studies on nonspecific disease (healthy participants) were included. All studies reported significant effectiveness in at least one or more outcomes. However results of evaluations with the TREND and CLEAR-NPT checklists generally showed a remarkable lack of description in the studies. Furthermore, there was the problem of heterogeneity, and we were therefore not able to perform a meta-analysis. Conclusion: Because there was insufficient evidence on aquatic exercise due to poor methodological and reporting quality and heterogeneity of nRCTs, we were unable to offer any conclusions about the effects of this intervention. However, we were able to identify problems with current nRCTs of aquatic exercise, and propose a strategy of strengthening study quality, stressing the importance of study feasibility as a future research agenda objective. PMID:21556311

Tomographic Structural Changes of Retinal Layers after Internal Limiting Membrane Peeling for Macular Hole Surgery.

PubMed

Faria, Mun Yueh; Ferreira, Nuno P; Cristóvao, Diana M; Mano, Sofia; Sousa, David Cordeiro; Monteiro-Grillo, Manuel

2018-01-01

To highlight tomographic structural changes of retinal layers after internal limiting membrane (ILM) peeling in macular hole surgery. Nonrandomized prospective, interventional study in 38 eyes (34 patients) subjected to pars plana vitrectomy and ILM peeling for idiopathic macular hole. Retinal layers were assessed in nasal and temporal regions before and 6 months after surgery using spectral domain optical coherence tomography. Total retinal thickness increased in the nasal region and decreased in the temporal region. The retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), and inner plexiform layer (IPL) showed thinning on both nasal and temporal sides of the fovea. The thickness of the outer plexiform layer (OPL) increased. The outer nuclear layer (ONL) and outer retinal layers (ORL) increased in thickness after surgery in both nasal and temporal regions. ILM peeling is associated with important alterations in the inner retinal layer architecture, with thinning of the RNFL-GCL-IPL complex and thickening of OPL, ONL, and ORL. These structural alterations can help explain functional outcome and could give indications regarding the extent of ILM peeling, even though peeling seems important for higher rate of hole closure. © 2017 S. Karger AG, Basel.

Soft tissue infection after missile injuries to the extremities--a non-randomized, prospective study in Gaza City.

PubMed

Hamouda, Hazem M; Witsø, Eivind; Moghani, Nedal K E; Shahwan, Ahmed; Nygaard, Oystein P

2007-01-01

Patients with soft tissue injuries caused by missile attacks during wartime have been treated with radical debridement and delayed closure. In a study in Gaza City, the rate of infection of missile injuries to the extremities when treated with minimal surgical intervention, was measured. Patients with severe soft tissue damage, compound fractures, and injuries to major blood vessels and/or nerves were excluded from the study. One hundred fourteen patients were treated according to a standardized regime that included a superficial, minor surgery revision of the inlet and the outlet opening, and antibiotic treatment. Local soft tissue infection was defined as the presence of at least two signs of local infection. A total of 109 out of 114 patients attended the first follow-up visit. Eleven (10%) of these patients had an infected wound. A total of 105 of the patients (92%) attended a second follow-up. None of these patients had an infected wound. Under conditions with a high number of casualties, minimal surgical treatment followed by the administration of antibiotics is a safe procedure for patients with penetrating missile injuries and less severe soft tissue damage.

Enhanced recovery pathways in pancreatic surgery: State of the art

PubMed Central

Pecorelli, Nicolò; Nobile, Sara; Partelli, Stefano; Cardinali, Luca; Crippa, Stefano; Balzano, Gianpaolo; Beretta, Luigi; Falconi, Massimo

2016-01-01

Pancreatic surgery is being offered to an increasing number of patients every year. Although postoperative outcomes have significantly improved in the last decades, even in high-volume centers patients still experience significant postoperative morbidity and full recovery after surgery takes longer than we think. In recent years, enhanced recovery pathways incorporating a large number of evidence-based perioperative interventions have proved to be beneficial in terms of improved postoperative outcomes, and accelerated patient recovery in the context of gastrointestinal, genitourinary and orthopedic surgery. The role of these pathways for pancreatic surgery is still unclear as high-quality randomized controlled trials are lacking. To date, non-randomized studies have shown that care pathways for pancreaticoduodenectomy and distal pancreatectomy are safe with no difference in postoperative morbidity, leading to early discharge and no increase in hospital readmissions. Hospital costs are reduced due to better organization of care and resource utilization. However, further research is needed to clarify the effect of enhanced recovery pathways on patient recovery and post-discharge outcomes following pancreatic resection. Future studies should be prospective and follow recent recommendations for the design and reporting of enhanced recovery pathways. PMID:27605881

The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis.

PubMed

Page, Amy T; Clifford, Rhonda M; Potter, Kathleen; Schwartz, Darren; Etherton-Beer, Christopher D

2016-09-01

Deprescribing is a suggested intervention to reverse the potential iatrogenic harms of inappropriate polypharmacy. The review aimed to determine whether or not deprescribing is a safe, effective and feasible intervention to modify mortality and health outcomes in older adults. Specified databases were searched from inception to February 2015. Two researchers independently screened all retrieved articles for inclusion, assessed study quality and extracted data. Data were pooled using RevMan v5.3. Eligible studies included those where older adults had at least one medication deprescribed. The primary outcome was mortality. Secondary outcomes were adverse drug withdrawal events, psychological and physical health outcomes, quality of life, and medication usage (e.g. successful deprescribing, number of medications prescribed, potentially inappropriate medication use). A total of 132 papers met the inclusion criteria, which included 34 143 participants aged 73.8 ± 5.4 years. In nonrandomized studies, deprescribing polypharmacy was shown to significantly decrease mortality (OR 0.32, 95% CI: 0.17-0.60). However, this was not statistically significant in the randomized studies (OR 0.82, 95% CI 0.61-1.11). Subgroup analysis revealed patient-specific interventions to deprescribe demonstrated a significant reduction in mortality (OR 0.62, 95% CI 0.43-0.88). However, generalized educational programmes did not change mortality (OR 1.21, 95% CI 0.86-1.69). Although nonrandomized data suggested that deprescribing reduces mortality, deprescribing was not shown to alter mortality in randomized studies. Mortality was significantly reduced when applying patient-specific interventions to deprescribe in randomized studies. © 2016 The British Pharmacological Society.

Comparison of Percutaneous Cementoplasty with and Without Interventional Internal Fixation for Impending Malignant Pathological Fracture of the Proximal Femur

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

Tian, Qing-Hua, E-mail: ddqinghua-tian@163.com; He, Cheng-Jian, E-mail: tianhechengjian@163.com; Wu, Chun-Gen, E-mail: 649514608@qq.com

PurposeTo compare the efficacy of percutaneous cementoplasty (PCP) with and without interventional internal fixation (IIF) on malignant impending pathological fracture of proximal femur.MethodsA total of 40 patients with malignant impending pathological fracture of proximal femur were selected for PCP and IIF (n = 19, group A) or PCP alone (n = 21, group B) in this non-randomized prospective study. Bone puncture needles were inserted into the proximal femur, followed by sequential installation of the modified trocar inner needles through the puncture needle sheath. Then, 15–45 ml cement was injected into the femur lesion.ResultsThe overall excellent and good pain relief rate during follow-ups were significantly highermore » in group A than that in group B (89 vs. 57 %, P = 0.034). The average change of VAS, ODI, KPS, and EFES in group A were significantly higher than those in group B at 1-, 3-, 6-month, 1-year (P < 0.05). Meanwhile, The stability of the treated femur was significantly higher in group A than that in group B (P < 0.05).ConclusionPCP and IIF were not only a safe and effective procedure, but resulted in greater pain relief, bone consolidation, and also reduced the risk of fracture than the currently recommended approach of PCP done on malignant proximal femoral tumor.« less

The Effect of Chin-cup Therapy in Class III Malocclusion: A Systematic Review

PubMed Central

Mousoulea, Sophia; Tsolakis, Ioannis; Ferdianakis, Efstratios; Tsolakis, Apostolos I.

2016-01-01

Background: The treatment of Class III malocclusion has been challenging for orthodontists. Among a plethora of treatment modalities, the chin-cup is considered a traditional appliance for early orthopedic intervention. Objective: The present study aims to investigate the current scientific evidence regarding the effectiveness of chin-cup therapy in Class III malocclusion of prognathic growing patients. Method: A systematic review of the literature was conducted using PubMed/Medline and the Cochrane Central Register of Controlled Trials from January 1954 to October 2015. Articles were selected based on established inclusion/ exclusion criteria. Results: The search strategy resulted in 3285 articles.14 studies were selected for the final analysis. They were all CCTs, 13 of retrospective and 1 of prospective design. Methodological quality was evaluated by a risk of bias assessment, as suggested by the Cochrane Risk of Bias Assessment Tool for Non-Randomized Studies on Interventions. The reported evidence presented favorable short-term outcomes both in hard and soft tissues improving the Class III profile, as well as desirable dento-alveolar changes, positively affecting the Class III malocclusion. Conclusion: There is considerable agreement between studies that chin-cup therapy can be considered for the short-term treatment of growing patients with Class III malocclusion, as indicated by favorable changes both in the hard and soft tissues. The existence of considerable risk of bias in all selected studies and the unclear long-term effectiveness of chin-cup therapy highlight the need for further investigation to draw reliable conclusions. PMID:28077971

Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

PubMed

Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

2014-06-01

Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

A Meta-Analysis of Interventions to Reduce Loneliness

PubMed Central

Masi, Christopher M.; Chen, Hsi-Yuan; Hawkley, Louise C.; Cacioppo, John T.

2013-01-01

Social and demographic trends are placing an increasing number of adults at risk for loneliness, an established risk factor for physical and mental illness. The growing costs of loneliness have led to a number of loneliness reduction interventions. Qualitative reviews have identified four primary intervention strategies: 1) improving social skills, 2) enhancing social support, 3) increasing opportunities for social contact, and 4) addressing maladaptive social cognition. An integrative meta-analysis of loneliness reduction interventions was conducted to quantify the effects of each strategy and to examine the potential role of moderator variables. Results revealed that single group pre-post and non-randomized comparison studies yielded larger mean effect sizes relative to randomized comparison studies. Among studies that used the latter design, the most successful interventions addressed maladaptive social cognition. This is consistent with current theories regarding loneliness and its etiology. Theoretical and methodological issues associated with designing new loneliness reduction interventions are discussed. PMID:20716644

Outcomes assessment in men undergoing open retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robotic-assisted radical prostatectomy.

PubMed

Kowalczyk, Keith J; Yu, Hua-Yin; Ulmer, William; Williams, Stephen B; Hu, Jim C

2012-02-01

To review the various methods of outcomes assessment used for effectiveness studies comparing retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), and robotic-assisted laparoscopic prostatectomy (RALP). A review of the peer reviewed literature was performed for reported series of RRP, LRP, and RALP using Pubmed and MEDLINE with emphasis on comparing perioperative, functional, and oncologic outcomes. Common methods used for outcomes assessment were categorized and compared, highlighting the pros and cons of each approach. The majority of the literature comparing RRP, LRP, and RALP comes in the form of observational data or administrative data from secondary datasets. While randomized controlled trials are ideal for outcomes assessment, only one such study was identified and was limited. Non-randomized observational studies contribute to the majority of data, however are limited due to retrospective study design, lack of consistent endpoints, and limited application to the general community. Administrative data provide accurate assessment of operative outcomes in both academic and community settings, however has limited ability to convey accurate functional outcomes. Non-randomized observational studies and secondary data are useful resources for assessment of outcomes; however, limitations exist for both. Neither is without flaws, and conclusions drawn from either should be viewed with caution. Until standardized prospective comparative analyses of RRP, LRP, and RALP are established, comparative outcomes data will remain imperfect. Urologic researchers must strive to provide the best available outcomes data through accurate prospective data collection and consistent outcomes reporting.

Effectiveness of yoga program in the management of diabetes using community health workers in the urban slums of Bangalore city: A non-randomized controlled trial

PubMed Central

Dasappa, Hemavathi; Fathima, Farah Naaz; Prabhakar, Rugmani

2016-01-01

Trial Design: Nonrandomized controlled trial. Methods: Nonrandomized controlled trial. This was an interventional study that was conducted in 4 slums of Bengaluru. Of the 256 diabetes participants, only 109 people agreed to participate in the program. Of 109 people, 52 people agreed to participate in the intervention (agreed to learn and practice Yoga) while the remaining 57 people were assigned to nonintervention group. Randomization and blinding could not be done. Objective and Outcome: The study was conducted with objective of assessing the effectiveness of Yoga, Pranayama, and Sudarshan Kriya in the community-based management of diabetes mellitus. The primary outcome variable was Hb1Ac and secondary outcome variables were systolic blood pressure (SBP), diastolic blood pressure (DBP), adherence to medication, and changes in lifestyle. Results: The study was conducted for 40 days. Community health workers made a total of 6 visits during the study. All the 109 participants were available for weekly follow-up. There were no drop outs among the study population. Statistically significant change was seen in the consumption of vegetable (χ2 = 15.326, P < 0.005), fruits (χ2 = 16.207, P < 0.005), salty food (χ2 = 14.823, P < 0.005), bakery food (χ2 = 10.429, P < 0.005) and fried food (χ2 = 15.470, P < 0.005), adherence to metformin (χ2 = 41.780, P < 0.005) and other medication(χ2 = 21.871, P < 0.005) and proportion of patients with DBP under control (χ2 = 9.396, P < 0.005) and proportion of people with glucose random blood sugar under control (χ2 = 29.693, P < 0.005) between the two groups following the intervention. Statistically significant change was also seen in the proportion of people with SBP/DBP ≤140/90 (χ2 = 10.635, P < 0.005) between the two groups. Conclusion: The Yoga program was successful in improving dietary practices and medication adherence and in increasing the proportion of diabetics and hypertensive patients under control. PMID:28217594

Mental Illness Stigma Intervention in African Americans: Examining Two Delivery Methods.

PubMed

Vinson, Ebony S; Abdullah, Tahirah; Brown, Tamara L

2016-05-01

Stigma surrounding mental illness and mental health treatment remains a significant problem, particularly among African Americans. This study sought to examine the effects of 2 intervention delivery methods in reducing reported stigma. African Americans (n = 158) were nonrandomly assigned to an in-person contact or video condition and administered a survey immediately before, after, and 2 weeks following the stigma intervention. The in vivo contact condition consisted of an African American man discussing his experiences with mental illness and psychotherapy. The session was recorded, and the recording was used for the video condition. There were no significant effects based on delivery method; however, there was a significant effect for time on stigma and help-seeking attitude measures. Further research is needed to determine the overall effectiveness of the intervention.

Estimating the Prevalence of Childhood Obesity in Alaska Using Partial, Nonrandom Measurement Data

PubMed Central

Boles, Myde; Fink, Karol; Topol, Rebecca; Fenaughty, Andrea

2016-01-01

Although monitoring childhood obesity prevalence is critical for state public health programs to assess trends and the effectiveness of interventions, few states have comprehensive body mass index measurement systems in place. In some states, however, assorted school districts collect measurements on student height and weight as part of annual health screenings. To estimate childhood obesity prevalence in Alaska, we created a logistic regression model using such annual measurements along with public data on demographics and socioeconomic status. Our mixed-effects model-generated prevalence estimates validated well against weighted estimates, with 95% confidence intervals overlapping between methodologies among 7 of 8 participating school districts. Our methodology accounts for variation in school-level and student-level demographic factors across the state, and the approach we describe can be applied by other states that have existing nonrandom student measurement data to estimate childhood obesity prevalence. PMID:27010843

Systematic review of physiotherapy interventions to improve gross motor capacity and performance in children and adolescents with an acquired brain injury.

PubMed

Baque, Emmah; Sakzewski, Leanne; Barber, Lee; Boyd, Roslyn N

2016-01-01

To systematically review the efficacy of physiotherapy interventions to improve gross motor capacity, performance and societal participation in children aged 5-17 years with an acquired brain injury (ABI). Randomized and non-randomized controlled trials, cohort, case series, case-control and case studies were included and classified according to grades of evidence. Methodological quality of studies was assessed using the Downs and Black (D&B) scale and quantitative data was analysed using effect sizes. Two home-based studies investigated functional strength training (one randomized controlled trial, n = 20, level 2b, D&B = 16/32 and one non-randomized self-control study, n = 19, level 4, D&B = 15/32). Four studies evaluated virtual reality including: one pilot study, n = 50, level 4, D&B = 22/32; one single-subject, non-concurrent, randomized multiple baseline study, n = 3, level 4, D&B = 15/32; one case series study, n = 2, level 4, D&B = 15/32; one case study, n = 1, level 4, D&B = 15/32. Effect sizes for the randomized controlled trial ranged between 0.30-1.29 for the Functional Reach and Timed Up and Go outcome measures. There is preliminary evidence to support the efficacy of physiotherapy interventions to improve gross motor outcomes in children with an ABI. Both functional strength training and virtual-reality based therapy are potential treatment options for clinicians to prescribe in either home or clinical settings.

Effectiveness of Kenya's Community Health Strategy in delivering community-based maternal and newborn health care in Busia County, Kenya: non-randomized pre-test post test study.

PubMed

Wangalwa, Gilbert; Cudjoe, Bennett; Wamalwa, David; Machira, Yvonne; Ofware, Peter; Ndirangu, Meshack; Ilako, Festus

2012-01-01

Maternal mortality ratio and neonatal mortality rate trends in Kenya have remained unacceptably high in a decade. In 2007, the Ministry of Public Health and Sanitation adopted a community health strategy to reverse the poor health outcomes in order to meet Millennium Development Goals 4 and 5. It aims at strengthening community participation and its ability to take action towards health. The study aimed at evaluating the effectiveness of the strategy in improving maternal and neonatal health outcomes in Kenya. Between 2008 and 2010, the African Medical and Research Foundation implemented a community-based maternal and newborn care intervention package in Busia County using the community health strategy approach. An interventional, non-randomized pre-test post test study design was used to evaluate change in essential maternal and neonatal care practices among mothers with children aged 0 - 23 months. There was statistically significant (p < 0.05) increase in attendance of at least four antenatal care visits (39% to 62%), deliveries by skilled birth attendants (31% to 57%), receiving intermittent preventive treatment (23% to 57%), testing for HIV during pregnancy (73% to 90%) and exclusive breastfeeding (20% to 52%). The significant increase in essential maternal and neonatal care practices demonstrates that, community health strategy is an appropriate platform to deliver community based interventions. The findings will be used by actors in the child survival community to improve current approaches, policies and practice in maternal and neonatal care.

Increasing Recreational Physical Activity in Patients With Chronic Low Back Pain: A Pragmatic Controlled Clinical Trial.

PubMed

Ben-Ami, Noa; Chodick, Gabriel; Mirovsky, Yigal; Pincus, Tamar; Shapiro, Yair

2017-02-01

Study Design Prospective, pragmatic, nonrandomized controlled clinical trial. Background Clinical guidelines recommend physical activity for the treatment of chronic low back pain. But engaging patients in physical activity has proven difficult. Known obstacles to physical activity include low self-efficacy and fear avoidance. Objectives This study tested the effectiveness of an enhanced transtheoretical model intervention (ETMI) aimed at increasing recreational physical activity in patients with chronic low back pain, in comparison to usual physical therapy. Methods Patients (n = 220) referred to physical therapy for chronic low back pain were allocated to ETMI or to a control group. The ETMI was delivered by physical therapists and based on behavior-change principles, combined with increased reassurance, therapeutic alliance, and exposure to reduce fear avoidance. The primary outcome was back pain-related disability (Roland-Morris Disability Questionnaire). Secondary outcomes included pain intensity, mental and physical health, and levels of physical activity. Results Intention-to-treat analysis in 189 patients at 12 months indicated that patients in the ETMI group had significantly lower disability compared to usual physical therapy. The difference in mean change from baseline between the interventions was 2.7 points (95% confidence interval: 0.9, 4.5) on the Roland-Morris Disability Questionnaire. At 12 months, worst pain, physical activity, and physical health were all significantly better in patients receiving ETMI. The average number of sessions was 3.5 for the ETMI group and 5.1 for controls. Conclusion Targeting obstacles to physical activity with an intervention that includes components to address self-efficacy and fear avoidance appears to be more effective than usual physical therapy care in reducing long-term disability. Further research is needed to explore the mechanisms that impact outcomes in this intervention package. Level of Evidence Therapy, level 2b. Registered June 7, 2012 at ClinicalTrials.gov (NCT01631344). J Orthop Sports Phys Ther 2017;47(2):57-66. doi:10.2519/jospt.2017.7057.

The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta‐analysis

PubMed Central

Clifford, Rhonda M.; Potter, Kathleen; Schwartz, Darren; Etherton‐Beer, Christopher D.

2016-01-01

Aims Deprescribing is a suggested intervention to reverse the potential iatrogenic harms of inappropriate polypharmacy. The review aimed to determine whether or not deprescribing is a safe, effective and feasible intervention to modify mortality and health outcomes in older adults. Methods Specified databases were searched from inception to February 2015. Two researchers independently screened all retrieved articles for inclusion, assessed study quality and extracted data. Data were pooled using RevMan v5.3. Eligible studies included those where older adults had at least one medication deprescribed. The primary outcome was mortality. Secondary outcomes were adverse drug withdrawal events, psychological and physical health outcomes, quality of life, and medication usage (e.g. successful deprescribing, number of medications prescribed, potentially inappropriate medication use). Results A total of 132 papers met the inclusion criteria, which included 34 143 participants aged 73.8 ± 5.4 years. In nonrandomized studies, deprescribing polypharmacy was shown to significantly decrease mortality (OR 0.32, 95% CI: 0.17–0.60). However, this was not statistically significant in the randomized studies (OR 0.82, 95% CI 0.61–1.11). Subgroup analysis revealed patient‐specific interventions to deprescribe demonstrated a significant reduction in mortality (OR 0.62, 95% CI 0.43–0.88). However, generalized educational programmes did not change mortality (OR 1.21, 95% CI 0.86–1.69). Conclusions Although nonrandomized data suggested that deprescribing reduces mortality, deprescribing was not shown to alter mortality in randomized studies. Mortality was significantly reduced when applying patient‐specific interventions to deprescribe in randomized studies. PMID:27077231

Issues Relating to Selective Reporting When Including Non-Randomized Studies in Systematic Reviews on the Effects of Healthcare Interventions

ERIC Educational Resources Information Center

Norris, Susan L.; Moher, David; Reeves, Barnaby C.; Shea, Beverley; Loke, Yoon; Garner, Sarah; Anderson, Laurie; Tugwell, Peter; Wells, George

2013-01-01

Background: Selective outcome and analysis reporting (SOR and SAR) occur when only a subset of outcomes measured and analyzed in a study is fully reported, and are an important source of potential bias. Key methodological issues: We describe what is known about the prevalence and effects of SOR and SAR in both randomized controlled trials (RCTs)…

The Effect of Acupressure on Pain in Cancer Patients With Bone Metastasis: A Nonrandomized Controlled Trial.

PubMed

Serçe, Sibel; Ovayolu, Özlem; Pirbudak, Lütfiye; Ovayolu, Nimet

2018-04-01

Pain is a serious and common problem in bone metastases. For this purpose, complementary and supportive practices are also applied along with medical treatment. This study was conducted for the purpose of evaluating the effect of acupressure on pain in cancer patients with bone metastasis. The study was conducted in a nonrandomized controlled trial with patients who applied to the radiotherapy unit of an oncology hospital. The data of the study were collected by using a questionnaire and the Visual Analog Scale. A total of 8 acupressure sessions, which lasted for approximately 10 minutes each (with warming and acupressure periods), was applied to the intervention group. The data were analyzed by using χ 2 test, paired t test, and Pearson's correlation coefficient. It was determined that the pain mean score of the intervention group was 7.6 ± 1.9 before the acupressure and decreased to 6.8 ± 1.9 after the acupressure and this result was statistically significant. On the other hand, no significant difference was determined in the pain mean score of the control group. Acupressure is applicable for cancer patients with bone metastasis by nursing staff after receiving brief training and may make a difference in relieving pain of the patients. Further well-designed trials should be conducted.

Interventions for disorder and severe intoxication in and around licensed premises, 1989-2009.

PubMed

Brennan, Iain; Moore, Simon C; Byrne, Ellie; Murphy, Simon

2011-04-01

To systematically review rigorous evaluation studies into the effectiveness of interventions in and around licensed premises that aimed to reduce severe intoxication and disorder. A systematic search was conducted. Papers that rigorously evaluated interventions based in and around licensed premises to reduce disorder or intoxication were included. Fifteen studies were identified, three randomized controlled trials and 12 non-randomized quasi-experimental evaluations. Outcome measures were intoxication (n = 6), disorder (n = 6) and intoxication and disorder (n = 3). Interventions included responsible beverage service training (n = 5), server violence prevention training (n = 1), enhanced enforcement of licensing regulations (n = 1), multi-level interventions (n = 5), licensee accords (n = 2) and a risk-focused consultation (n = 1). Intervention effects varied, even across studies using similar interventions. Server training courses that are designed to reduce disorder have some potential, although there is a lack of evidence to support their use to reduce intoxication and the evidence base is weak. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Interventions to prevent misconduct and promote integrity in research and publication.

PubMed

Marusic, Ana; Wager, Elizabeth; Utrobicic, Ana; Rothstein, Hannah R; Sambunjak, Dario

2016-04-04

Improper practices and unprofessional conduct in clinical research have been shown to waste a significant portion of healthcare funds and harm public health. Our objective was to evaluate the effectiveness of educational or policy interventions in research integrity or responsible conduct of research on the behaviour and attitudes of researchers in health and other research areas. We searched the CENTRAL, MEDLINE, LILACS and CINAHL health research bibliographical databases, as well as the Academic Search Complete, AGRICOLA, GeoRef, PsycINFO, ERIC, SCOPUS and Web of Science databases. We performed the last search on 15 April 2015 and the search was limited to articles published between 1990 and 2014, inclusive. We also searched conference proceedings and abstracts from research integrity conferences and specialized websites. We handsearched 14 journals that regularly publish research integrity research. We included studies that measured the effects of one or more interventions, i.e. any direct or indirect procedure that may have an impact on research integrity and responsible conduct of research in its broadest sense, where participants were any stakeholders in research and publication processes, from students to policy makers. We included randomized and non-randomized controlled trials, such as controlled before-and-after studies, with comparisons of outcomes in the intervention versus non-intervention group or before versus after the intervention. Studies without a control group were not included in the review. We used the standard methodological procedures expected by Cochrane. To assess the risk of bias in non-randomized studies, we used a modified Cochrane tool, in which we used four out of six original domains (blinding, incomplete outcome data, selective outcome reporting, other sources of bias) and two additional domains (comparability of groups and confounding factors). We categorized our primary outcome into the following levels: 1) organizational change attributable to intervention, 2) behavioural change, 3) acquisition of knowledge/skills and 4) modification of attitudes/perceptions. The secondary outcome was participants' reaction to the intervention. Thirty-one studies involving 9571 participants, described in 33 articles, met the inclusion criteria. All were published in English. Fifteen studies were randomized controlled trials, nine were controlled before-and-after studies, four were non-equivalent controlled studies with a historical control, one was a non-equivalent controlled study with a post-test only and two were non-equivalent controlled studies with pre- and post-test findings for the intervention group and post-test for the control group. Twenty-one studies assessed the effects of interventions related to plagiarism and 10 studies assessed interventions in research integrity/ethics. Participants included undergraduates, postgraduates and academics from a range of research disciplines and countries, and the studies assessed different types of outcomes.We judged most of the included randomized controlled trials to have a high risk of bias in at least one of the assessed domains, and in the case of non-randomized trials there were no attempts to alleviate the potential biases inherent in the non-randomized designs.We identified a range of interventions aimed at reducing research misconduct. Most interventions involved some kind of training, but methods and content varied greatly and included face-to-face and online lectures, interactive online modules, discussion groups, homework and practical exercises. Most studies did not use standardized or validated outcome measures and it was impossible to synthesize findings from studies with such diverse interventions, outcomes and participants. Overall, there is very low quality evidence that various methods of training in research integrity had some effects on participants' attitudes to ethical issues but minimal (or short-lived) effects on their knowledge. Training about plagiarism and paraphrasing had varying effects on participants' attitudes towards plagiarism and their confidence in avoiding it, but training that included practical exercises appeared to be more effective. Training on plagiarism had inconsistent effects on participants' knowledge about and ability to recognize plagiarism. Active training, particularly if it involved practical exercises or use of text-matching software, generally decreased the occurrence of plagiarism although results were not consistent. The design of a journal's author contribution form affected the truthfulness of information supplied about individuals' contributions and the proportion of listed contributors who met authorship criteria. We identified no studies testing interventions for outcomes at the organizational level. The numbers of events and the magnitude of intervention effects were generally small, so the evidence is likely to be imprecise. No adverse effects were reported. The evidence base relating to interventions to improve research integrity is incomplete and the studies that have been done are heterogeneous, inappropriate for meta-analyses and their applicability to other settings and population is uncertain. Many studies had a high risk of bias because of the choice of study design and interventions were often inadequately reported. Even when randomized designs were used, findings were difficult to generalize. Due to the very low quality of evidence, the effects of training in responsible conduct of research on reducing research misconduct are uncertain. Low quality evidence indicates that training about plagiarism, especially if it involves practical exercises and use of text-matching software, may reduce the occurrence of plagiarism.

Novel and emerging treatments for autism spectrum disorders: a systematic review.

PubMed

Rossignol, Daniel A

2009-01-01

Currently, only one medication (risperidone) is FDA-approved for the treatment of autism spectrum disorders (ASD). Perhaps for this reason, the use of novel, unconventional, and off-label treatments for ASD is common, with up to 74% of children with ASD using these treatments; however, treating physicians are often unaware of this usage. A systematic literature search of electronic scientific databases was performed to identify studies of novel and emerging treatments for ASD, including nutritional supplements, diets, medications, and nonbiological treatments. A grade of recommendation ("Grade") was then assigned to each treatment using a validated evidence-based guideline as outlined in this review: A: Supported by at least 2 prospective randomized controlled trials (RCTs) or 1 systematic review. B: Supported by at least 1 prospective RCT or 2 nonrandomized controlled trials. C: Supported by at least 1 nonrandomized controlled trial or 2 case series. D: Troublingly inconsistent or inconclusive studies or studies reporting no improvements. Potential adverse effects for each treatment were also reviewed. Grade A treatments for ASD include melatonin, acetylcholinesterase inhibitors, naltrexone, and music therapy. Grade B treatments include carnitine, tetrahydrobiopterin, vitamin C, alpha-2 adrenergic agonists, hyperbaric oxygen treatment, immunomodulation and anti-inflammatory treatments, oxytocin, and vision therapy. Grade C treatments for ASD include carnosine, multivitamin/mineral complex, piracetam, polyunsaturated fatty acids, vitamin B6/magnesium, elimination diets, chelation, cyproheptadine, famotidine, glutamate antagonists, acupuncture, auditory integration training, massage, and neurofeedback. The reviewed treatments for ASD are commonly used, and some are supported by prospective RCTs. Promising treatments include melatonin, antioxidants, acetylcholinesterase inhibitors, naltrexone, and music therapy. All of the reviewed treatments are currently considered off-label for ASD (ie, not FDA-approved) and some have adverse effects. Further studies exploring these treatments are needed. Physicians treating children with an ASD should make it standard practice to inquire about each child's possible use of these types of treatments.

Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial.

PubMed

Wang, Jing-jing; Lau, Wing-chung Patrick; Wang, Hai-jun; Ma, Jun

2015-12-03

With regard to the global childhood obesity epidemic, it is imperative that effective lifestyle interventions are devised to combat childhood obesity. This paper describes the development and implementation of a comprehensive (a combination of diet and physical activity (PA)), social cognitive behaviour modification intervention using accelerometry and a dietary diary to tackle child overweight and obesity. The comprehensive intervention effect was evaluated in a comparison with diet only, PA only and a no-treatment control group. A pilot study was conducted with a non-randomized cluster design. Four hundred thirty-eight overweight and obese children aged 7-12 years from ten primary schools in Beijing were recruited to receive a one-year intervention. Participants were allocated into one of four groups: the comprehensive intervention group; the PA only group (Happy 10 program); the diet only group (nutrition education program); and a control group. The effects of intervention on adiposity, blood pressure, and biochemical indicators were assessed by examining 2-way interactions (time × intervention) in linear mixed models. Means and 95 % confidence intervals (CI) for the adjusted changes between post-intervention and baseline relative to changes in the control group were calculated and reported as effect sizes. The percentage of body fat in the comprehensive intervention group showed a significant relative decrease (adjusted change: -1.01 %, 95 % CI: (-1.81, -0.20) %) compared with the PA only, diet only or control groups (P < 0.001). Systolic blood pressure significantly decreased in the comprehensive intervention group (adjusted change: -4.37 mmHg, 95 % CI: (-8.42, -0.33) mmHg), as did diastolic blood pressure (adjusted change: -5.50 mmHg, 95 % CI (-8.81, -2.19) mmHg) (P < 0.05). Compared with the other two intervention groups and the control group, positive adjusted changes in fasting glucose in the comprehensive group were found, although not for the biochemical lipid metabolism indicators. Positive but non-significant adjusted changes in body mass index and waist circumference were observed. Compared with the diet or PA only intervention groups, the current comprehensive program had superior positive effects on body fat percentage and blood pressure but not on the biochemical lipid metabolism indicators in Chinese overweight and obese children. Future randomized controlled trials and long-term follow-up studies are required to elaborate the findings of the current intervention. ClinicalTrials.gov identifier: NCT02228434.

Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

PubMed

Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

2009-04-01

A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

Seven Deadly Sins in Trauma Outcomes Research: An Epidemiologic Post-Mortem for Major Causes of Bias

PubMed Central

del Junco, Deborah J.; Fox, Erin E.; Camp, Elizabeth A.; Rahbar, Mohammad H.; Holcomb, John B.

2013-01-01

Background Because randomized clinical trials (RCTs) in trauma outcomes research are expensive and complex, they have rarely been the basis for the clinical care of trauma patients. Most published findings are derived from retrospective and occasionally prospective observational studies that may be particularly susceptible to bias. The sources of bias include some common to other clinical domains, such as heterogeneous patient populations with competing and interdependent short- and long-term outcomes. Other sources of bias are unique to trauma, such as rapidly changing multi-system responses to injury that necessitate highly dynamic treatment regimes like blood product transfusion. The standard research design and analysis strategies applied in published observational studies are often inadequate to address these biases. Methods Drawing on recent experience in the design, data collection, monitoring and analysis of the 10-site observational PROMMTT study, seven common and sometimes overlapping biases are described through examples and resolution strategies. Results Sources of bias in trauma research include ignoring 1) variation in patients’ indications for treatment (indication bias), 2) the dependency of intervention delivery on patient survival (survival bias), 3) time-varying treatment, 4) time-dependent confounding, 5) non-uniform intervention effects over time, 6) non-random missing data mechanisms, and 7) imperfectly defined variables. This list is not exhaustive. Conclusion The mitigation strategies to overcome these threats to validity require epidemiologic and statistical vigilance. Minimizing the highlighted types of bias in trauma research will facilitate clinical translation of more accurate and reproducible findings and improve the evidence-base that clinicians apply in their care of injured patients. PMID:23778519

Impact of the reduction of anaesthesia turnover time on operating room efficiency.

PubMed

Sokolovic, E; Biro, P; Wyss, P; Werthemann, C; Haller, U; Spahn, D; Szucs, T

2002-08-01

We investigated whether an increase in anaesthesia staffing to permit induction of anaesthesia before the previous case had ended ('overlapping') would increase overall efficiency in the operating room. Hitherto, the average duration of operating sessions was too long, thus impeding the timely commencement of physicians' ward duties. The investigation was designed as a prospective, non-randomized, interrupted time-series analysis divided into three phases: (a) a baseline of 3.5 months, (b) a 2.5 month intervention phase, in which anaesthesia staffing was increased by one attending physician and one nurse, and (c) a further 2 months under baseline conditions. Data focussed on process management were collected from operating room staff, anaesthesia personnel and surgeons using a structured questionnaire collected daily during the entire study. Turnover time between consecutive operations decreased from 65 to 52 min per operation (95% CI: 9; 17; P = 0.0001). Operating room occupancy increased from 4:28 to 5:27 h day-1 (95% CI: 50; 68; P = 0.005). The surgeons began their work on the ward 35 min (95% CI: 30; 40) later than before the intervention and their overtime increased from 22:36 to 139:50 h. The time between surgical operations decreased significantly. Increased operating room efficiency owing to overlapping induction of anaesthesia allows more intense scheduling of operations. Thus, physicians and nurses can be released to spend more time with their patients in the ward. Improving the efficiency of the operating room alone is insufficient to improve human resource management at all levels of a surgical clinic.

The Effect of Intra-articular Injection of Autologous Microfragmented Fat Tissue on Proteoglycan Synthesis in Patients with Knee Osteoarthritis

PubMed Central

Borić, Igor; Rod, Eduard; Jeleč, Željko; Radić, Andrej; Vrdoljak, Trpimir; Skelin, Andrea; Trbojević-Akmačić, Irena; Plečko, Mihovil; Primorac, Dragan

2017-01-01

Osteoarthritis (OA) is one of the leading musculoskeletal disorders in the adult population. It is associated with cartilage damage triggered by the deterioration of the extracellular matrix tissue. The present study explores the effect of intra-articular injection of autologous microfragmented adipose tissue to host chondrocytes and cartilage proteoglycans in patients with knee OA. A prospective, non-randomized, interventional, single-center, open-label clinical trial was conducted from January 2016 to April 2017. A total of 17 patients were enrolled in the study, and 32 knees with osteoarthritis were assessed. Surgical intervention (lipoaspiration) followed by tissue processing and intra-articular injection of the final microfragmented adipose tissue product into the affected knee(s) was performed in all patients. Patients were assessed for visual analogue scale (VAS), delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) and immunoglobulin G (IgG) glycans at the baseline, three, six and 12 months after the treatment. Magnetic resonance sequence in dGEMRIC due to infiltration of the anionic, negatively charged contrast gadopentetate dimeglumine (Gd-DTPA2−) into the cartilage indicated that the contents of cartilage glycosaminoglycans significantly increased in specific areas of the treated knee joint. In addition, dGEMRIC consequently reflected subsequent changes in the mechanical axis of the lower extremities. The results of our study indicate that the use of autologous and microfragmented adipose tissue in patients with knee OA (measured by dGEMRIC MRI) increased glycosaminoglycan (GAG) content in hyaline cartilage, which is in line with observed VAS and clinical results. PMID:29027984

Thermic sealing in femoral catheterisation: First experience with the Secure Device.

PubMed

Sacherer, Michael; Kolesnik, Ewald; von Lewinski, Friederike; Verheyen, Nicolas; Brandner, Karin; Wallner, Markus; Eaton, Deborah M; Luha, Olev; Zweiker, Robert; von Lewinski, Dirk

2018-04-03

Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The SECURE arterial closure device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the SECURE device to close the puncture site following percutaneous cardiac catheterization. The SECURE device was evaluated in a prospective non-randomized single-centre trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. 50 diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. The new SECURE device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the SECURE device was non-inferior to other closure devices as tested in the ISAR closure trial.

Migraine Nurses in Primary Care: Costs and Benefits.

PubMed

van den Berg, Jan S P; Steiner, Timothy J; Veenstra, Petra J L; Kollen, Boudewijn J

2017-09-01

We examined the costs and benefits of introducing migraine nurses into primary care. Migraine is one of the most costly neurological diseases. We analyzed data from our earlier nonrandomized cohort study comparing an intervention group of 141 patients, whose care was supported by nurses trained in migraine management, and a control group of 94 patients receiving usual care. Estimates of per-person direct costs were based on nurses' salaries and referrals to neurologists. Indirect costs were estimated as lost productivity, including numbers of days of absenteeism or with <50% productivity at work due to migraine, and notional costs related to lost days of household activities or days of <50% household productivity. Analysis was conducted from the payer's perspective. After 9 months the direct costs were €281.11 in the control group against €332.23 in the intervention group (mean difference -51.12; 95% CI: -113.20-15.56; P = .134); the indirect costs were €1985.51 in the control group against €1631.75 in the intervention group (mean difference 353.75; 95% CI: -355.53-1029.82; P = .334); and total costs were €2266.62 in the control group, against €1963.99 in the intervention group (mean difference 302.64; 95% CI: -433.46-1001.27; P = .438). When costs attributable to lost household productivity were included, total costs increased to €6076.62 in the control group and €5048.15 in the intervention group (mean difference 1028.47; 95% CI: -590.26-2603.67; P = .219). Migraine nurses in primary care seemed in this study to increase practice costs but decrease total societal costs. However, it was a nonrandomized study, and the differences did not reach significance. For policy-makers concerned with headache-service organization and delivery, the important messages are that we found no evidence that nurses increased overall costs, and investment in a definitive study would therefore be worthwhile. © 2017 American Headache Society.

The effects of asking a fertility intention question in primary care settings: a systematic review protocol.

PubMed

Henning, Paul A; Burgess, Carolyne K; Jones, Heidi E; Norman, Wendy V

2017-01-19

Planning for pregnancy has been associated with reduced unwanted pregnancies and improved pregnancy outcomes. Despite the benefits of planned pregnancy, there are no guideline recommendations on routine counseling regarding pregnancy intention in primary care settings. The objective of the systematic review is to determine the effectiveness of incorporating questions of pregnancy intention into primary care. A systematic search of the literature will be conducted for any studies comparing questions of pregnancy intention in primary care settings with no intervention or a control intervention. Types of studies will include randomized controlled trials, non-randomized trials, and observation studies. Participants will include patients of reproductive age presenting to primary health care settings. Interventions will include any assessment of fertility intention and follow-up care compared with a control group or no intervention. Outcomes will include quantitative data with rates for contraceptive uptake, and any pregnancy related outcome. Databases (Ovid MEDLINE; Pubmed; CINAHL; EMBASE; CDR/DARE databases; Web of Science; ISRCTN registry; Clinicaltrials.gov; Cochrane Library) will be searched from the year 2000 to current. Screening of identified articles and data extraction will be conducted in duplicate by two independent reviewers. Methodological quality will be assessed using the Jadad scale. Methodological quality of observational and non-randomized trials will be assessed using the Newcastle-Ottawa scale. Discrepancies will be resolved by consensus or by consulting a third author. Meta-analyses will be performed if appropriate. Determining the effect of including questions of pregnancy intention into primary care can provide evidence for the development of clinical practice guidelines and inform primary care providers if this simple and low-cost intervention should be routinely employed. This review will also identify any gaps in the current literature on this topic and provide direction for future research in this area of study. Systematic Review Registration: PROSPERO CRD42015019726.

Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

PubMed

Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

2016-10-01

The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

Efficacy of Health Education using Facebook to Promote Healthy Lifestyle among Medical Students in Puducherry, India: A Non-Randomized Controlled Trial.

PubMed

Krishnamohan, Smrithi; Stalin, P; Singh, Zile; Sridhar, Maghida

2017-07-01

Increasing burden of overweight and obesity among young adults is mainly due to unhealthy lifestyle especially with respect to diet and physical activity. At the same time, younger generations are spending more time with social network sites. Therefore, this study was intended to explore the role of social networking sites in promoting healthy lifestyle. To measure the efficacy of health education using social networking sites in promoting healthy lifestyle among medical students in Puducherry, India. A non-randomized controlled trial was conducted in a private medical college located in Puducherry. The study participants were overweight/obese individuals with (intervention arm) and without Facebook account (control arm). Following a baseline survey, both the groups received health education from dietician and physical trainer using Audiovisual (AV) aids. Intervention group received health education through Facebook in the forms of messages, pictures and videos for six weeks. Then, follow up survey was done to assess the change in dietary pattern, physical activity and body weight. Data of those who attended baseline, intervention and follow up surveys (23- control and 22- intervention) were analysed. Means and proportions were calculated. Paired t-test and Chi-square test were used to calculate the p-value. The p-value<0.05 was considered as statistically significant. Mean number of days of junk food intake per week was reduced in both control and intervention groups from 2.91 days/week and 3.27 days/week at baseline to 2.65 days/week to two days/week at follow up respectively. A significant decrease in the Body Mass Index (BMI) (p<0.05) was found among the control group (baseline: 25.57, follow up: 25.15). No significant changes were found with respect to physical activity and intake of fruits and vegetables. Except for the decrease in junk food intake, use of Facebook as an effective tool to promote healthy lifestyle could not be proved with confidence.

Preemptive Isolation Precautions of Patients at High Risk for Methicillin-Resistant Staphylococcus aureus in Combination With Ultrarapid Polymerase Chain Reaction Screening as an Effective Tool for Infection Control.

PubMed

Hallak, Ghias; Neuner, Bruno; Schefold, Joerg C; Gorzelniak, Kerstin; Rapsch, Brigitte; Pfüller, Roland; Stengel, Dirk; Wellmann, Jürgen; Ekkernkamp, Axel; Walter, Michael

2016-12-01

This sequential nonrandomized intervention study investigated the role of preemptive isolation precautions plus ultrarapid polymerase chain reaction screening for methicillin-resistant Staphylococcus aureus (MRSA). Compared with no prophylactic isolation plus conventional microbiology MRSA screening, nosocomial MRSA colonization and total MRSA incidence per 10,000 patient days significantly decreased. Infect Control Hosp Epidemiol 2016;1489-1491.

Impact of a community-based prevention marketing intervention to promote physical activity among middle-aged women.

PubMed

Sharpe, Patricia A; Burroughs, Ericka L; Granner, Michelle L; Wilcox, Sara; Hutto, Brent E; Bryant, Carol A; Peck, Lara; Pekuri, Linda

2010-06-01

A physical activity intervention applied principles of community-based participatory research, the community-based prevention marketing framework, and social cognitive theory. A nonrandomized design included women ages 35 to 54 in the southeastern United States. Women (n = 430 preprogram, n = 217 postprogram) enrolled in a 24-week behavioral intervention and were exposed to a media campaign. They were compared to cross-sectional survey samples at pre- (n = 245) and postprogram (n = 820) from the media exposed county and a no-intervention county (n = 234 pre, n = 822 post). Women in the behavioral intervention had statistically significant positive changes on physical activity minutes, walking, park and trail use, knowledge of mapped routes and exercise partner, and negative change on exercise self-efficacy. Media exposed women had statistically significant pre- to postprogram differences on knowledge of mapped routes. No-intervention women had significant pre- to postprogram differences on physical activity minutes, walking, and knowledge of mapped routes.

Evaluation of a Socio-Cultural Intervention to Reduce Unprotected Sex for HIV Among African American/Black Women

PubMed Central

Boekeloo, B; Geiger, T; Wang, M; Ishman, N; Quinton, S; Allen, G; Ali, B; Snow, D

2015-01-01

African American/Black (Black) women suffer disproportionately to other women from HIV. An HIV prevention intervention combining two previous evidenced-based HIV intervention programs; “Coping with Work and Family Stress” and “Hip Hop 2 Prevent Substance Abuse and HIV”, was evaluated in a diverse sample of Black women (n=205). Study participants at 10 recruitment sites were assigned non-randomly to either the intervention or comparison group and then surveyed at baseline, immediate posttest, and 6-month follow-up. General Estimating Equation modeling revealed that participants in the comparison group reported less unprotected sex at immediate post-test and the intervention group less unprotected sex at 6-month follow-up. Despite the initial drop in reported unprotected sex in the comparison group, this study suggests that an HIV risk reduction intervention tailored to address Black women’s socio-cultural stress and enhance their coping may reduce their unprotected sex at 6-months. PMID:25645327

Effects of Bobath-based therapy on depression, shoulder pain and health-related quality of life in patients after stroke.

PubMed

Hafsteinsdóttir, Thóra B; Kappelle, Jaap; Grypdonck, Maria H F; Algra, Ale

2007-10-01

To measure the effects of Bobath-based (BB) therapy on depression, shoulder pain and health-related quality of life (HRQoL) of patients during one year after stroke. In a prospective, non-randomized design, the use of BB therapy was compared with a more task-oriented therapy and no BB therapy. A total of 324 patients in 12 hospitals. Patients in the intervention group received BB therapy, whereas patients in the control group received no BB therapy and a more task-oriented therapy. HRQoL was measured using the SF-36; depression was measured with the Center of Epidemiological Studies Depression Scale and shoulder pain was measured with the Visual Analogue Scale at discharge, 6 and 12 months. Linear and logistic regression analyses were performed. No effects of BB therapy on HRQoL or shoulder pain were found. After one year fewer patients were depressed in the BB group (30%) than in the non-BB group (43%); the adjusted odds ratio was 0.6 (95% confidence interval 0.3-1.0). BB therapy did not have any effect on HRQoL or shoulder pain in stroke patients. Healthcare professionals should reconsider the use of BB therapy in the care of stroke patients.

Review of Yoga Therapy During Cancer Treatment

PubMed Central

Danhauer, Suzanne C.; Addington, Elizabeth L.; Sohl, Stephanie J.; Chaoul, Alejandro; Cohen, Lorenzo

2017-01-01

Purpose Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Methods Studies were identified via research databases and reference lists. Inclusion criteria: (1) children or adults undergoing cancer treatment; (2) intervention stated as yoga or component of yoga; and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria: (1) samples receiving hormone therapy only; (2) interventions involving only meditation; and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results Results of non-randomized (adult: n=8, pediatric: n=4) and randomized controlled trials (adult: n=13, pediatric: n=0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Conclusions Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines. PMID:28064385

Effectiveness of Kenya's Community Health Strategy in delivering community-based maternal and newborn health care in Busia County, Kenya: non-randomized pre-test post test study

PubMed Central

Wangalwa, Gilbert; Cudjoe, Bennett; Wamalwa, David; Machira, Yvonne; Ofware, Peter; Ndirangu, Meshack; Ilako, Festus

2012-01-01

Background Maternal mortality ratio and neonatal mortality rate trends in Kenya have remained unacceptably high in a decade. In 2007, the Ministry of Public Health and Sanitation adopted a community health strategy to reverse the poor health outcomes in order to meet Millennium Development Goals 4 and 5. It aims at strengthening community participation and its ability to take action towards health. The study aimed at evaluating the effectiveness of the strategy in improving maternal and neonatal health outcomes in Kenya. Methods Between 2008 and 2010, the African Medical and Research Foundation implemented a community-based maternal and newborn care intervention package in Busia County using the community health strategy approach. An interventional, non-randomized pre-test post test study design was used to evaluate change in essential maternal and neonatal care practices among mothers with children aged 0 - 23 months. Results There was statistically significant (p < 0.05) increase in attendance of at least four antenatal care visits (39% to 62%), deliveries by skilled birth attendants (31% to 57%), receiving intermittent preventive treatment (23% to 57%), testing for HIV during pregnancy (73% to 90%) and exclusive breastfeeding (20% to 52%). Conclusion The significant increase in essential maternal and neonatal care practices demonstrates that, community health strategy is an appropriate platform to deliver community based interventions. The findings will be used by actors in the child survival community to improve current approaches, policies and practice in maternal and neonatal care. PMID:23467438

Reduction of Family Violence in Aboriginal Communities: A Systematic Review of Interventions and Approaches1

PubMed Central

Shea, Beverley; Nahwegahbow, Amy; Andersson, Neil

2010-01-01

Many efforts to reduce family violence are documented in the published literature. We conducted a systematic review of interventions intended to prevent family violence in Aboriginal communities. We retrieved studies published up to October 2009; 506 papers included one systematic review, two randomized controlled trials, and fourteen nonrandomized studies or reviews. Two reviews discussed interventions relevant to primary prevention (reducing the risk factors for family violence), including parenting, role modelling, and active participation. More studies addressed secondary prevention (where risk factors exist, reducing outbreaks of violence) such as restriction on the trading hours for take away alcohol and home visiting programs for high risk families. Examples of tertiary prevention (preventing recurrence) include traditional healing circles and group counselling. Most studies contributed a low level of evidence. PMID:21052554

Effects of the Use of the Provider Resilience Mobile Application in Reducing Compassion Fatigue in Oncology Nursing.

PubMed

Jakel, Patricia; Kenney, Jillian; Ludan, Natalia; Miller, Pamela S; McNair, Norma; Matesic, Edith

2016-12-01

Oncology nurses have increased exposure to the prolonged illness, tragedy, loss, and premature death of patients. As a result, they are at higher risk for developing compassion fatigue. The aim of this study was to examine if use of the Provider Resilience mobile application (PRMA) will improve oncology nurses' professional quality of life. The quasiexperimental design was comprised of a longitudinal approach to evaluate the effect of an intervention program, PRMA, on professional quality of life between two nonrandomized groups (intervention and control) using pre- and post-tests in a sample of oncology RNs. The findings of this study demonstrated no significant relationships between the intervention and control groups on secondary traumatic stress, compassion satisfaction, and burnout among oncology nurses.

Quasi-experimental study designs series-paper 6: risk of bias assessment.

PubMed

Waddington, Hugh; Aloe, Ariel M; Becker, Betsy Jane; Djimeu, Eric W; Hombrados, Jorge Garcia; Tugwell, Peter; Wells, George; Reeves, Barney

2017-09-01

Rigorous and transparent bias assessment is a core component of high-quality systematic reviews. We assess modifications to existing risk of bias approaches to incorporate rigorous quasi-experimental approaches with selection on unobservables. These are nonrandomized studies using design-based approaches to control for unobservable sources of confounding such as difference studies, instrumental variables, interrupted time series, natural experiments, and regression-discontinuity designs. We review existing risk of bias tools. Drawing on these tools, we present domains of bias and suggest directions for evaluation questions. The review suggests that existing risk of bias tools provide, to different degrees, incomplete transparent criteria to assess the validity of these designs. The paper then presents an approach to evaluating the internal validity of quasi-experiments with selection on unobservables. We conclude that tools for nonrandomized studies of interventions need to be further developed to incorporate evaluation questions for quasi-experiments with selection on unobservables. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of a Combined Tai Chi, Resistance Training and Dietary Intervention on Cognitive Function in Obese Older Women.

PubMed

Xu, F; Delmonico, M J; Lofgren, I E; Uy, K M; Maris, S A; Quintanilla, D; Taetzsch, A G; Letendre, J; Mahler, L

2017-01-01

Cognitive decline in older adults is a major public health problem and can compromise independence and quality of life. Exercise and diet have been studied independently and have shown to be beneficial for cognitive function, however, a combined Tai Chi, resistance training, and diet intervention and its influence on cognitive function has not been undertaken. The current study used a 12-week non-randomized research design with experiment and control groups to examine the effect of a combined Tai Chi, resistance training, and diet intervention on cognitive function in 25 older obese women. Results revealed improvements in domain specific cognitive function in our sample. Baseline cognitive function was correlated with changes in dietary quality. These findings suggest that Tai Chi and resistance training combined with diet intervention might be beneficial for community-based programs aiming to improve cognitive function.

A Nonrandomized Comparison Study of Self-Hypnosis, Yoga, and Cognitive-Behavioral Therapy to Reduce Emotional Distress in Breast Cancer Patients.

PubMed

Bragard, Isabelle; Etienne, Anne-Marie; Faymonville, Marie-Elisabeth; Coucke, Philippe; Lifrange, Eric; Schroeder, Hélène; Wagener, Aurélie; Dupuis, Gilles; Jerusalem, Guy

2017-01-01

The authors asked breast cancer (BC) patients to participate in 1 of 3 mind-body interventions (cognitive-behavioral therapy (CBT), yoga, or self-hypnosis) to explore their feasibility, ease of compliance, and impact on the participants' distress, quality of life (QoL), sleep, and mental adjustment. Ninety-nine patients completed an intervention (CBT: n = 10; yoga: n = 21; and self-hypnosis: n = 68). Results showed high feasibility and high compliance. After the interventions, there was no significant effect in the CBT group but significant positive effects on distress in the yoga and self-hypnosis groups, and, also, on QoL, sleep, and mental adjustment in the self-hypnosis group. In conclusion, mind-body interventions can decrease distress in BC patients, but RCTs are needed to confirm these findings.

E-mail communication in pain practice: The importance of being earnest.

PubMed

Ruiz, Irene Solera; García, Guadalupe Población; Riquelme, Irene

2014-07-01

Information technology can play a vital role in meeting patient needs and reinforcing the relationship among patients and their pain physicians. However, strong resistance remains on the medical side to this type of non-frontal care. The primary objective of this study was to assess the effectiveness of an E-mail intervention on customers' satisfaction. The secondary goals were to analyze the messages from patients to their clinician (not only the volume but also the content) and the impact on client, professional and health services outcomes. A prospective, non-randomized evaluation of patients undergoing treatment for chronic pain from September 2011 to May 2012. A private, specialty referral center in Spain. Participants were users visiting the Pain Management Unit evaluated by one physician. The E-mail address of the facility was written in every medical report provided. Patient satisfaction at the end of the 8-month trial period was assessed and outcomes recorded. Patients reported better communication with their therapist and greater satisfaction with overall care. 780 E-mails were read. Specialists received an average of 5 messages per day (standard deviation 0,3). None of them was unsuitable. This is a prospective, single center evaluation performed by one doctor. There was no control group due to ethical considerations. Electronic communication is a cheap, easy and feasible way to address a wide range of concerns, thus enhancing patients' satisfaction. More efforts are needed to implement routinely usage of this tool. If used appropriately, E-mail can facilitate physician-dependent interactions, promote access to care, save time and reduce costs. Concerns about billing, improper utilization, privacy and confidentiality might complicate its introduction and acceptance. Internet access remains a significant barrier to online patient-provider transference.

Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

PubMed

Yin, Way; Pauza, Kevin; Olan, Wayne J; Doerzbacher, Jeff F; Thorne, Kevin J

2014-01-01

Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. Prospective, nonrandomized Food and Drug Administration approved pilot study. Three centers in the United States. Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain. Wiley Periodicals, Inc.

Prospective, nonrandomized controlled trials to compare the effect of a silk-like fabric to standard hospital linens on the rate of hospital-acquired pressure ulcers.

PubMed

Coladonato, Joseph; Smith, Annette; Watson, Nancy; Brown, Anne T; McNichol, Laurie L; Clegg, Amy; Griffin, Tracy; McPhail, Lora; Montgomery, Terry G

2012-10-01

Hospital bedding and gowns influence skin moisture, temperature, friction, and shear, which in turn may affect the development of pressure ulcers. To evaluate the effect of a new silk-like synthetic fabric on the incidence of pressure ulcers in an acute care setting, two consecutive 6-month clinical trials were conducted among 307 consecutively admitted patients in a Medical Renal Unit (August 2008 and March 2010) and in 275 patients admitted to a Surgical Intensive Care Unit (ICU) (September 2009 to March 2010). During the first 8 weeks, all patients used standard hospital bed linens, reusable underpads, and gowns. During the second 8 weeks, all admitted patients used the intervention linens (a silk-like fabric) followed by another 8 weeks of control (standard linen) use. Demographic variables and the prevalence of pressure ulcers on admission were statistically similar for control and intervention groups in both study populations with the exception of gender in the Renal Unit study (13% higher proportion of men in intervention group). Average Braden Scores were also similar and low (<18) in all study patients. Upon admission to the Medical Renal Unit, 21 of 154 patients (13.6%) in the control and 26 of 153 patients (17.0%) in the intervention group had a pressure ulcer. The incidence of new ulcers was 12.3% in the control and 4.6% in the intervention group (P = 0.01); average length of stay was 5.97 days (σ = 4.0) for control and 5.31 days (σ = 3.8) for intervention patients (P = 0.07). In the Surgical ICU group, 18 of 199 patients in the control (9.1%) and four of 76 patients in the intervention group (5.3%) were admitted with a pressure ulcer; the incidence of new pressure ulcers was 7.5 % in the control and 0% in the intervention group (P = 0.01). Average length of stay was 4.5 days and 4.33 days in the control and intervention groups, respectively (P = 0.33). The significant differences between the control and intervention group in the rate of pressure ulcer development suggests that the type of linens used affect pressure ulcer risk and that this silk-like synthetic fabric technology may help reduce the incidence of pressure ulcers in high-risk patients. Controlled clinical studies in other patient populations are warranted.

The SCIDOTS Project: Evidence of benefits of an integrated tobacco cessation intervention in tuberculosis care on treatment outcomes

PubMed Central

2011-01-01

Background There is substantial evidence to support the association between tuberculosis (TB) and tobacco smoking and that the smoking-related immunological abnormalities in TB are reversible within six weeks of cessation. Therefore, connecting TB and tobacco cessation interventions may produce significant benefits and positively impact TB treatment outcomes. However, no study has extensively documented the evidence of benefits of such integration. SCIDOTS Project is a study from the context of a developing nation aimed to determine this. Methods An integrated TB-tobacco intervention was provided by trained TB directly observed therapy short-course (DOTS) providers at five chest clinics in Malaysia. The study was a prospective non-randomized controlled intervention using quasi-experimental design. Using Transtheoretical Model approach, 120 eligible participants who were current smokers at the time of TB diagnosis were assigned to either of two treatment groups: conventional TB DOTS plus smoking cessation intervention (integrated intervention or SCIDOTS group) or conventional TB DOTS alone (comparison or DOTS group). At baseline, newly diagnosed TB patients considering quitting smoking within the next 30 days were placed in the integrated intervention group, while those who were contemplating quitting were assigned to the comparison group. Eleven sessions of individualized cognitive behavioral therapy with or without nicotine replacement therapy were provided to each participant in the integrated intervention group. The impacts of the novel approach on biochemically validated smoking cessation and TB treatment outcomes were measured periodically as appropriate. Results A linear effect on both 7-day point prevalence abstinence and continuous abstinence was observed over time in the intervention group. At the end of 6 months, patients who received the integrated intervention had significantly higher rate of success in quitting smoking when compared with those who received the conventional TB treatment alone (77.5% vs. 8.7%; p < 0.001). Furthermore, at the end of TB treatment (6 months or later), there were significantly higher rates of treatment default (15.2% vs. 2.5%; p = 0.019) and treatment failure (6.5% vs. 0%; p = 0.019) in the DOTS group than in the SCIDOTS group. Conclusion This study provides evidence that connecting TB-tobacco treatment strategy is significant among TB patients who are smokers. The findings suggest that the integrated approach may be beneficial and confer advantages on short-term outcomes and possibly on future lung health of TB patients who quit smoking. This study may have important implications on health policy and clinical practice related to TB management among tobacco users. PMID:21943384

Ayurvedic interventions for osteoarthritis: a systematic review and meta-analysis.

PubMed

Kessler, Christian S; Pinders, Lea; Michalsen, Andreas; Cramer, Holger

2015-02-01

Ayurveda is one of the fastest growing systems within complementary and alternative medicine. However, the evidence for its effectiveness is unsatisfactory. The aim of this work was to review and meta-analyze the effectiveness and safety of different Ayurvedic interventions in patients with osteoarthritis (OA). 138 electronic databases were searched through August 2013. Randomized controlled trials, randomized crossover studies, cluster-randomized trials, and non-randomized controlled clinical trials were eligible. Adults with pre-diagnosed OA were included as participants. Interventions were included as Ayurvedic if they were explicitly labeled as such. Main outcome measures were pain, physical function, and global improvement. Risk of bias was assessed using the Cochrane risk of bias tool. 19 randomized and 14 non-randomized controlled trials on 12 different drugs and 3 non-pharmaceutical interventions with a total of 2,952 patients were included. For the compound preparation, Rumalaya, large and apparently unbiased effects beyond placebo were found for pain (standardized mean difference [SMD] -3.73; 95 % confidence interval [CI] -4.97, -2.50; P < 0.01) and global improvement (risk ratio 12.20; 95 % CI 5.83, 25.54; P < 0.01). There is also some evidence that effects of the herbal compound preparation Shunti-Guduchi are comparable to those of glucosamine for pain (SMD 0.08; 95 % CI -0.20, 0.36; P = 0.56) and function (SMD 0.15; 95 % CI -0.12, 0.36; P = 0.41). Based on single trials, positive effects were found for the compound preparations RA-11, Reosto, and Siriraj Wattana. For Boswellia serrata, Lepidium Sativum, a Boswellia serrata containing multicomponent formulation and the compounds Nirgundi Taila, Panchatikta Ghrita Guggulu, and Rhumayog, and for non-pharmacological interventions like Ayurvedic massage, steam therapy, and enema, no evidence for significant effects against potential methodological bias was found. No severe adverse events were observed in all trials. The drugs Rumalaya and Shunti-Guduchi seem to be safe and effective drugs for treatment of OA-patients, based on these data. However, several limitations relate to clinical research on Ayurveda. Well-planned, well-conducted and well-published trials are warranted to improve the evidence for Ayurvedic interventions.

Does implementing a development plan for user participation in a mental hospital change patients' experience? A non-randomized controlled study.

PubMed

Rise, Marit B; Steinsbekk, Aslak

2015-10-01

Governments in several countries attempt to strengthen user participation through instructing health-care organizations to implement user participation initiatives. There is, however, little knowledge on the effect on patients' experience from comprehensive plans for enhancing user participation in whole health service organizations. To investigate whether implementing a development plan intending to enhance user participation in a mental hospital had any effect on the patients' experience of user participation. A non-randomized controlled study including patients in three mental hospitals in Central Norway, one intervention hospital and two control hospitals. A development plan intended to enhance user participation was implemented in the intervention hospital as a part of a larger reorganizational process. The plan included establishment of a patient education centre and a user office, purchase of user expertise, appointment of contact professionals for next of kin and improvement of the centre's information and the professional culture. Perceptions of Care, Inpatient Treatment Alliance Scale and questions made for this study. A total of 1651 patients participated. Implementing a development plan in a mental hospital intending to enhance user participation had no significant effect on the patients' experience of user participation. The lack of effect can be due to inappropriate initiatives or challenges in implementation processes. Further research should ensure that initiatives and implementation processes are appropriate to impact the patients' experience. © 2013 John Wiley & Sons Ltd.

Three-dimensional vascular imaging of proliferative diabetic retinopathy by Doppler optical coherence tomography.

PubMed

Miura, Masahiro; Hong, Young-Joo; Yasuno, Yoshiaki; Muramatsu, Daisuke; Iwasaki, Takuya; Goto, Hiroshi

2015-03-01

To evaluate the 3-dimensional architecture of neovascularization in proliferative diabetic retinopathy using Doppler optical coherence tomography (OCT). Prospective, nonrandomized clinical trial. Seventeen eyes of 14 patients with proliferative diabetic retinopathy were prospectively studied. Prototype Doppler OCT was used to evaluate the 3-dimensional vascular architecture at vitreoretinal adhesions. Proliferative membranes were detected in all eyes with proliferative diabetic retinopathy by standard OCT images. Doppler OCT images detected blood flow by neovascularization of the disc in 12 eyes and neovascularization elsewhere in 11 eyes. Doppler OCT images showed the 3-dimensional extent of new vessels at various stages of neovascularization, and the extent of new vessels could be clearly confirmed at vitreoretinal adhesions. Doppler OCT is useful for the detection and evaluation of the 3-dimensional vascular structure of neovascularization, and can assist in the noninvasive assessment of proliferative diabetic retinopathy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

The Effects of Expressive Writing Interventions for Patients With Cancer: A Meta-Analysis.

PubMed

Oh, Pok-Ja; Kim, Soo Hyun

2016-07-01

To evaluate the effects of expressive writing (EW) interventions in patients with cancer.
. Electronic databases searched included both international and Korean databases through January 2015.
. Of the 20 trials that met the eligibility criteria of this review, a meta-analysis was conducted of 14 articles involving 13 randomized and 1 nonrandomized trials with 1,718 patients with cancer. EW interventions were compared with a neutral writing intervention or usual care (no writing). A significant small effect was noted on relieving cancer symptoms; however, the effects on psychological and cognitive outcomes were not significant. When subgroup analysis by control condition was performed, a significant effect on health-related quality of life was found between the EW intervention group and the usual care group. 
. EW had significant small effects only on cancer symptoms. The findings suggest that the traditional EW intervention protocol may need to be intensified to confirm its effect on patients with cancer.
. Current evidence for EW as a nursing intervention for improving physical, psychological, and cognitive outcomes among patients with cancer is promising, but not conclusive.

Challenging mental health related stigma in China: Systematic review and meta-analysis. I. Interventions among the general public.

PubMed

Xu, Ziyan; Rüsch, Nicolas; Huang, Fangfang; Kösters, Markus

2017-09-01

Mental illness stigma is widely endorsed by the general public in China. Evidence-based anti-stigma interventions to reduce public stigma are needed. However, most studies on the efficacy of anti-stigma interventions took place in Western countries and existing Chinese studies were often not included in recent systematic reviews. This review evaluates the efficacy of anti-stigma interventions among the general population in Mainland China, Hong Kong, Taiwan and Macau. Eight databases in English and Chinese were searched for randomized and non-randomized controlled trials. Subgroup analyses compared interventions with and without consumer contact. Standardized mean differences were calculated from eligible studies where possible. We included 9 trials involving 2041 participants. Interventions yielded a small effect on stereotypes reduction and a similar effect on improving mental health literacy. No study assessed discrimination outcomes. Interventions with consumer contact were not superior to those without. There were insufficient data on medium and long term effects. Heterogeneity across studies was moderate. Quality of studies was modest. Further research using rigorous methods is required. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery

PubMed Central

Van Lieshout, Ryan J.; Schmidt, Louis A.; Dobson, Kathleen G.; Buckley, Norman

2016-01-01

Objective To examine the effectiveness of Audiovisual (AV) interventions at reducing preoperative anxiety and its associated outcomes in children undergoing elective surgery. Methods A systematic review of randomized controlled trials (RCTs) and nonrandomized studies where the primary outcome was children’s preoperative anxiety was conducted. Secondary outcomes included postoperative pain, behavioral changes, recovery, induction compliance, satisfaction, and cost-effectiveness. The risk of bias of each study was assessed. Results In all, 18 studies were identified. A meta-analytic approach and narrative synthesis of findings were used to summarize the results of the studies. Conclusions This systematic review suggests that AV interventions can be effective in reducing children’s preoperative anxiety. Videos, multi-faceted programs, and interactive games appear to be most effective, whereas music therapy and Internet programs are less effective. While AV interventions appear potentially useful, adequately powered RCTs are required to conclusively pinpoint the components and mechanisms of the most effective AV interventions and guide practice. PMID:26476281

HIV Interventions to Reduce HIV/AIDS Stigma: A Systematic Review

PubMed Central

Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

2011-01-01

We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest–posttest with a non-randomized control group, or pretest–posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/ AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance. PMID:21088989

Prevention of postpartum hemorrhage at home birth in Afghanistan.

PubMed

Sanghvi, Harshadkumar; Ansari, Nasratullah; Prata, Ndola J V; Gibson, Hannah; Ehsan, Aftab T; Smith, Jeffrey M

2010-03-01

To test the safety, acceptability, feasibility, and effectiveness of community-based education and distribution of misoprostol for prevention of postpartum hemorrhage at home birth in Afghanistan. A nonrandomized experimental control design in rural Afghanistan. A total of 3187 women participated: 2039 in the intervention group and 1148 in the control group. Of the 1421 women in the intervention group who took misoprostol, 100% correctly took it after birth, including 20 women with twin pregnancies. Adverse effect rates were unexpectedly lower in the intervention group than in the comparison group. Among women in the intervention group, 92% said they would use misoprostol in their next pregnancy. In the intervention area where community-based distribution of misoprostol was introduced, near-universal uterotonic coverage (92%) was achieved compared with 25% coverage in the control areas. In Afghanistan, community-based education and distribution of misoprostol is safe, acceptable, feasible, and effective. This strategy should be considered for other countries where access to skilled attendance is limited.

HIV interventions to reduce HIV/AIDS stigma: a systematic review.

PubMed

Sengupta, Sohini; Banks, Bahby; Jonas, Dan; Miles, Margaret Shandor; Smith, Giselle Corbie

2011-08-01

We reviewed the literature to determine the effectiveness of HIV-related interventions in reducing HIV/AIDS stigma. Studies selected had randomized controlled trial (RCT), pretest-posttest with a non-randomized control group, or pretest-posttest one group study designs in which HIV-related interventions were being evaluated, and in which HIV/AIDS stigma was one of the outcomes being measured. A checklist was used to extract data from accepted studies, assess their internal validity, and overall quality. Data were extracted from 19 studies, and 14 of these studies demonstrated effectiveness in reducing HIV/AIDS stigma. Only 2 of these 14 effective studies were considered good studies, based on quality, the extent to which the intervention focused on reducing HIV/AIDS stigma, and the statistics reported to demonstrate effectiveness. Future studies to reduce HIV/AIDS stigma could improve by designing interventions that pay greater attention to internal validity, use validated HIV/AIDS stigma instruments, and achieve both statistical and public health significance.

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

Systematic Review and Meta-Analysis of Extraperitoneal Versus Transperitoneal Colostomy for Preventing Parastomal Hernia.

PubMed

Kroese, Leonard F; de Smet, Gijs H J; Jeekel, Johannes; Kleinrensink, Gert-Jan; Lange, Johan F

2016-07-01

Parastomal hernia remains a frequent problem after constructing a colostomy. Current research mainly focuses on prophylactic mesh placement as an addition to transperitoneal colostomies. However, for constructing a colostomy, either an extraperitoneal or transperitoneal route can be chosen. The aim of this meta-analysis was to investigate which technique results in lower parastomal hernia rates in patients undergoing end colostomy. A meta-analysis was conducted according to Preferred Items for Reporting of Systematic Reviews and Meta-Analyses and Meta-Analysis of Observational Studies in Epidemiology guidelines. Embase, MEDLINE, Web of Science, Scopus, Cumulative Index to Nursing and Allied Health Literature, Cochrane, PubMed, and Google Scholar databases were searched. The study protocol was registered in the International Prospective Register of Systematic Reviews database. Studies comparing extraperitoneal and transperitoneal colostomies were included. Only studies written in English were included. The quality of studies and risk of bias were assessed using the Cochrane risk-of-bias tool. The quality of nonrandomized studies was assessed using the Newcastle-Ottawa Scale. The intervention was colostomy formation. The main outcome measure was parastomal hernia incidence. Secondary outcome measures were stoma prolapse, stoma necrosis, and operating time. Of 401 articles found, a meta-analysis was conducted of 10 studies (2 randomized controlled trials and 8 retrospective studies) composed of 1048 patients (347 extraperitoneal and 701 transperitoneal). Extraperitoneal colostomy led to significantly lower parastomal hernia rates (22 of 347 (6.3%) for extraperitoneal versus 125 of 701 (17.8%) for transperitoneal; risk ratio = 0.36 (95% CI, 0.21-0.62); I = 26%; p < 0.001) and significantly lower stoma prolapse rates (2 of 185 (1.1%) for extraperitoneal versus 13 of 179 (7.3%) for transperitoneal; risk ratio = 0.21 (95% CI, 0.06-0.73); I = 0%; p = 0.01). Differences in stoma necrosis were not significant. Operating time data were insufficient to analyze. Most of the studies were nonrandomized, and some were not recent publications. Although the majority of studies included were retrospective, extraperitoneal colostomy was observed to lead to a lower rate of parastomal hernia and stoma prolapse.

Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force Report--Part I.

PubMed

Berger, Marc L; Mamdani, Muhammad; Atkins, David; Johnson, Michael L

2009-01-01

Health insurers, physicians, and patients worldwide need information on the comparative effectiveness and safety of prescription drugs in routine care. Nonrandomized studies of treatment effects using secondary databases may supplement the evidence based from randomized clinical trials and prospective observational studies. Recognizing the challenges to conducting valid retrospective epidemiologic and health services research studies, a Task Force was formed to develop a guidance document on state of the art approaches to frame research questions and report findings for these studies. The Task Force was commissioned and a Chair was selected by the International Society for Pharmacoeconomics and Outcomes Research Board of Directors in October 2007. This Report, the first of three reported in this issue of the journal, addressed issues of framing the research question and reporting and interpreting findings. The Task Force Report proposes four primary characteristics-relevance, specificity, novelty, and feasibility while defining the research question. Recommendations included: the practice of a priori specification of the research question; transparency of prespecified analytical plans, provision of justifications for any subsequent changes in analytical plan, and reporting the results of prespecified plans as well as results from significant modifications, structured abstracts to report findings with scientific neutrality; and reasoned interpretations of findings to help inform policy decisions. Comparative effectiveness research in the form of nonrandomized studies using secondary databases can be designed with rigorous elements and conducted with sophisticated statistical methods to improve causal inference of treatment effects. Standardized reporting and careful interpretation of results can aid policy and decision-making.

The effects of Sahaja Yoga meditation on mental health: a systematic review.

PubMed

Hendriks, Tom

2018-05-30

Objectives To determine the efficacy of Sahaja Yoga (SY) meditation on mental health among clinical and healthy populations. Methods All publications on SY were eligible. Databases were searched up to November 2017, namely PubMed, MEDLINE (NLM), PsychINFO, and Scopus. An internet search (Google Scholar) was also conducted. The quality of the randomized controlled trails was assessed using the Cochrane Risk Assessment for Bias. The quality of cross-sectional studies, a non-randomized controlled trial and a cohort study was assessed with the Newcastle-Ottawa Quality Assessment Scale. Results We included a total of eleven studies; four randomized controlled trials, one non-randomized controlled trial, five cross-sectional studies, and one prospective cohort study. The studies included a total of 910 participants. Significant findings were reported in relation to the following outcomes: anxiety, depression, stress, subjective well-being, and psychological well-being. Two randomized studies were rated as high quality studies, two randomized studies as low quality studies. The quality of the non-randomized trial, the cross-sectional studies and the cohort study was high. Effect sizes could not be calculated in five studies due to unclear or incomplete reporting. Conclusions After reviewing the articles and taking the quality of the studies into account, it appears that SY may reduce depression and possibly anxiety. In addition, the practice of SY is also associated with increased subjective wellbeing and psychological well-beng. However, due to the limited number of publications, definite conclusions on the effects of SY cannot be made and more high quality randomized studies are needed to justify any firm conclusions on the beneficial effects of SY on mental health.

Design and rationale of the ANALYZE ST study: a prospective, nonrandomized, multicenter ST monitoring study to detect acute coronary syndrome events in implantable cardioverter-defibrillator patients.

PubMed

Gibson, C Michael; Krucoff, Mitchell; Kirtane, Ajay J; Rao, Sunil V; Mackall, Judith A; Matthews, Ray; Saba, Samir; Waksman, Ron; Holmes, David

2014-10-01

In the setting of ST-segment elevation myocardial infarction, timely restoration of normal blood flow is associated with improved myocardial salvage and survival. Despite improvements in door-to-needle and door-to-balloon times, there remains an unmet need with respect to improved symptom-to-door times. A prior report of an implanted device to monitor ST-segment deviation demonstrated very short times to reperfusion among patients with an acute coronary syndrome (ACS) with documented thrombotic occlusion. The goal of the ANALYZE ST study is to evaluate the safety and effectiveness of a novel ST-segment monitoring feature using an existing implantable cardioverter-defibrillator (ICD) among patients with known coronary artery disease. The ANALYZE ST study is a prospective, nonrandomized, multicenter, pivotal Investigational Device Exemption study enrolling 5,228 patients with newly implanted ICD systems for standard clinical indications who also have a documented history of coronary artery disease. Patients will be monitored for 48 months, during which effectiveness of the device for the purpose of early detection of cardiac injury will be evaluated by analyzing the sensitivity of the ST monitoring feature to identify clinical ACS events. In addition, the safety of the ST monitoring feature will be evaluated through the assessment of the percentage of patients for which monitoring produces a false-positive event over the course of 12 months. The ANALYZE ST trial is testing the hypothesis that the ST monitoring feature in the Fortify ST ICD system (St. Jude Medical, Inc., St. Paul, MN) (or other ICD systems with the ST monitoring feature) will accurately identify patients with clinical ACS events. Copyright © 2014 Mosby, Inc. All rights reserved.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

Selected pharmacokinetic issues of the use of antiepileptic drugs and parenteral nutrition in critically ill patients

PubMed Central

2010-01-01

Objectives To conduct a systematic review for the evidence supporting or disproving the reality of parenteral nutrition- antiepileptic drugs interaction, especially with respect to the plasma protein-binding of the drug. Methods The articles related to the topic were identified through Medline and PubMed search (1968-Feburary 2010) for English language on the interaction between parenteral nutrition and antiepileptic drugs; the search terms used were anti-epileptic drugs, parenteral nutrition, and/or interaction, and/or in vitro. The search looked for prospective randomized and nonrandomized controlled studies; prospective nonrandomized uncontrolled studies; retrospective studies; case reports; and in vitro studies. Full text of the articles were then traced from the Universiti Sains Malaysia (USM) library subscribed databases, including Wiley-Blackwell Library, Cochrane Library, EBSCOHost, OVID, ScienceDirect, SAGE Premier, Scopus, SpringerLINK, and Wiley InterScience. The articles from journals not listed by USM library were traced through inter library loan. Results There were interactions between parenteral nutrition and drugs, including antiepileptics. Several guidelines were designed for the management of illnesses such as traumatic brain injuries or cancer patients, involving the use of parenteral nutrition and antiepileptics. Moreover, many studies demonstrated the in vitro and in vivo parenteral nutrition -drugs interactions, especially with antiepileptics. Conclusions There was no evidence supporting the existence of parenteral nutrition-antiepileptic drugs interaction. The issue has not been studied in formal researches, but several case reports and anecdotes demonstrate this drug-nutrition interaction. However, alteration in the drug-free fraction result from parenteral nutrition-drug (i.e. antiepileptics) interactions may necessitate scrupulous reassessment of drug dosages in patients receiving these therapies. This reassessment may be particularly imperative in certain clinical situations characterized by hypoalbuminemia (e.g., burn patients). PMID:21194458

A Prospective, Nonrandomized, no Placebo-Controlled, Phase I/II Clinical Trial Assessing the Safety and Efficacy of Intramuscular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Severe Buerger’s Disease

PubMed Central

Ra, Jeong Chan; Jeong, Euicheol C.; Kang, Sung Keun; Lee, Seog Ju; Choi, Kyoung Ho

2017-01-01

Buerger’s disease is a rare and severe disease affecting the blood vessels of the limbs. Adipose tissue-derived mesenchymal stem cells (ADSCs) have the potential to cure Buerger’s disease when developed as a stem cell drug. In the present study, we conducted a prospective, nonrandomized, no placebo-controlled, phase I/II clinical trial with a 2-year follow-up questionnaire survey. A total of 17 patients were intramuscularly administered autologous ADSCs at a dose of 5 million cells/kg. The incidence of adverse events (AEs), adverse drug reaction (ADR), and serious adverse events (SAEs) was monitored. No ADRs and SAEs related to stem cell treatment occurred during the 6-month follow-up. In terms of efficacy, the primary endpoint was increase in total walking distance (TWD). The secondary endpoint was improvement in rest pain, increase in pain-free walking distance (PFWD), toe–brachial pressure index (TBPI), transcutaneous oxygen pressure (TcPO2), and arterial brachial pressure index (ABPI). ADSCs demonstrated significant functional improvement results including increased TWD, PFWD, and rest pain reduction. No amputations were reported during the 6-month clinical trial period and in the follow-up questionnaire survey more than 2 years after the ADSC injection. In conclusion, intramuscular injection of ADSCs is very safe and is shown to prompt functional improvement in patients with severe Buerger’s disease at a dosage of 300 million cells per 60 kg of body weight. However, the confirmatory therapeutic efficacy and angiogenesis need further study. PMID:28713639

Patient Acceptability of the Yorkshire Dialysis Decision Aid (YoDDA) Booklet: A Prospective Non-Randomized Comparison Study Across 6 Predialysis Services.

PubMed

Winterbottom, Anna E; Gavaruzzi, Teresa; Mooney, Andrew; Wilkie, Martin; Davies, Simon J; Crane, Dennis; Tupling, Ken; Baxter, Paul D; Meads, David M; Mathers, Nigel; Bekker, Hilary L

2016-01-01

♦ Patients are satisfied with their kidney care but want more support in making dialysis choices. Predialysis leaflets vary across services, with few being sufficient to enable patients' informed decision making. We describe the acceptability of a patient decision aid and feasibility of evaluating its effectiveness within usual predialysis practice. ♦ Prospective non-randomized comparison design, Usual Care or Usual Care Plus Yorkshire Dialysis Decision Aid Booklet (+YoDDA), in 6 referral centers (Yorkshire-Humber, UK) for patients with sustained deterioration of kidney function. Consenting (C) patients completed questionnaires after predialysis consultation (T1), and 6 weeks later (T2). Measures assessed YoDDA's utility to support patients' decisions and integration within usual care. ♦ Usual Care (n = 105) and +YoDDA (n = 84) participant characteristics were similar: male (62%), white (94%), age (mean = 62.6; standard deviation [SD] 14.4), kidney disease severity (glomerular filtration rate [eGFR] mean = 14.7; SD 3.7); decisional conflict was < 25; choice-preference for home versus hospital dialysis approximately 50:50. Patients valued receiving YoDDA, reading it on their own (96%), and sharing it with family (72%). The +YoDDA participants had higher scores for understanding kidney disease, reasoning about options, feeling in control, sharing their decision with family. Study engagement varied by center (estimated range 14 - 49%; mean 45%); participants varied in completion of decision quality measures. ♦ Receiving YoDDA as part of predialysis education was valued and useful to patients with worsening kidney disease. Integrating YoDDA actively within predialysis programs will meet clinical guidelines and patient need to support dialysis decision making in the context of patients' lifestyle. Copyright © 2016 International Society for Peritoneal Dialysis.

Moving from idea to action: promoting physical activity by empowering adolescents.

PubMed

Lindqvist, Anna-Karin; Mikaelsson, Katarina; Westerberg, Mats; Gard, Gunvor; Kostenius, Catrine

2014-11-01

Physical activity provides fundamental health benefits for children and youth. The aim of the study was to explore the possibility of conducting an empowerment-inspired intervention and examine the impact of the intervention in promoting moderate and vigorous physical activity (MVPA) among adolescents. A nonrandomized trial with a concurrent control group was carried out. Physical activity data were collected before and after the intervention with daily questions by short message service. Self-efficacy, social support, and attitude were also measured before and after the intervention since they were possible mediators. The intervention was created by the students, the researchers, and the teachers using an empowerment-based approach. Students in the intervention group (n = 21) increased their MVPA on average by 4.9 (SD = 28.9) minutes per day, and students in the control group (n = 25) reduced their MVPA on average by 25.4 (SD = 23.0) minutes per day (p = .000). The intervention might have contributed to a promotion of physical activity among students in the intervention group. The most valuable contribution this study provides is the knowledge that it is possible to develop and conduct an empowerment-inspired intervention to promote adolescent physical activity. © 2014 Society for Public Health Education.

What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews.

PubMed

Makady, Amr; de Boer, Anthonius; Hillege, Hans; Klungel, Olaf; Goettsch, Wim

Despite increasing recognition of the value of real-world data (RWD), consensus on the definition of RWD is lacking. To review definitions publicly available for RWD to shed light on similarities and differences between them. A literature review and stakeholder interviews were used to compile data from eight groups of stakeholders. Data from documents and interviews were subjected to coding analysis. Definitions identified were classified into four categories: 1) data collected in a non-randomized controlled trial setting, 2) data collected in a non-interventional/non-controlled setting, 3) data collected in a non-experimental setting, and 4) others (i.e., data that do not fit into the other three categories). The frequency of definitions identified per category was recorded. Fifty-three documents and 20 interviews were assessed. Thirty-eight definitions were identified: 20 out of 38 definitions (53%) were category 1 definitions, 9 (24%) were category 2 definitions, 5 (13%) were category 3 definitions, and 4 (11%) were category 4 definitions. Differences were identified between, and within, definition categories. For example, opinions differed on the aspects of intervention with which non-interventional/non-controlled settings should abide. No definitions were provided in two interviews or identified in 33 documents. Most of the definitions defined RWD as data collected in a non-randomized controlled trial setting. A considerable number of definitions, however, diverged from this concept. Moreover, a significant number of authors and stakeholders did not have an official, institutional definition for RWD. Persisting variability in stakeholder definitions of RWD may lead to disparities among different stakeholders when discussing RWD use in decision making. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Review of yoga therapy during cancer treatment.

PubMed

Danhauer, Suzanne C; Addington, Elizabeth L; Sohl, Stephanie J; Chaoul, Alejandro; Cohen, Lorenzo

2017-04-01

Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

Development, feasibility, and efficacy of a customized exercise device to deliver intradialytic resistance training in patients with end stage renal disease: Non-randomized controlled crossover trial.

PubMed

Chan, Danwin; Green, Simon; Fiatarone Singh, Maria; Barnard, Robert; Cheema, Birinder S

2016-10-01

Introduction This study assessed the feasibility and efficacy of a novel resistance training device used within an intradialytic progressive resistance training (PRT) intervention. Methods Non-randomized, within-subjects crossover design with outcomes assessed at baseline (week 0), postcontrol (week 13) and post-PRT intervention (week 26). Twenty-two hemodialysis patients (59% men, 71 ± 11 years) performed PRT three sessions per week for 12 weeks. The resistance training device was developed to enable the performance of 2 upper body and 3 lower body exercises, unilaterally and bilaterally, both before and during dialysis, with loads of 2.5 to 59 kg. Feasibility outcomes included adverse events, adherence and training load progression. Changes in upper and lower body muscular strength, six-minute walk, aspects of health-related quality of life (HRQoL) and depression were evaluated. Findings The PRT intervention was delivered without serious adverse events, resulted in 71.2% ± 23.3% adherence and significant adaptation of all training loads from pre to mid to post training (83.8%-185.6%, all P < 0.05). Lower body strength (P < 0.001) and HRQoL subscales (Role-Physical, Social Functioning, Role-Emotional) significantly increased (all P < 0.01) and a trend toward reduced depression was noted (P = 0.06). No significant changes were noted in other outcomes. Discussion PRT using the novel resistance training device was feasible and improved measures of physical and psychological health. This device can be utilized in most dialysis centers. Future studies are required to evaluate dose-response effects of PRT prescriptions in subpopulations, and the translation of PRT to standard dialysis practice. © 2016 International Society for Hemodialysis.

A school intervention for mental health literacy in adolescents: effects of a non-randomized cluster controlled trial

PubMed Central

2013-01-01

Background “Mental health for everyone” is a school program for mental health literacy and prevention aimed at secondary schools (13–15 yrs). The main aim was to investigate whether mental health literacy, could be improved by a 3-days universal education programme by: a) improving naming of symptom profiles of mental disorder, b) reducing prejudiced beliefs, and c) improving knowledge about where to seek help for mental health problems. A secondary aim was to investigate whether adolescent sex and age influenced the above mentioned variables. A third aim was to investigate whether prejudiced beliefs influenced knowledge about available help. Method This non-randomized cluster controlled trial included 1070 adolescents (53.9% boys, M age14 yrs) from three schools in a Norwegian town. One school (n = 520) received the intervention, and two schools (n = 550) formed the control group. Pre-test and follow-up were three months apart. Linear mixed models and generalized estimating equations models were employed for analysis. Results Mental health literacy improved contingent on the intervention, and there was a shift towards suggesting primary health care as a place to seek help. Those with more prejudiced beleifs did not suggest places to seek help for mental health problems. Generally, girls and older adolescents recognized symptom profiles better and had lower levels of prejudiced beliefs. Conclusions A low cost general school program may improve mental health literacy in adolescents. Gender specific programs and attention to the age and maturity of the students should be considered when mental health literacy programmes are designed and tried out. Prejudice should be addressed before imparting information about mental health issues. PMID:24053381

Evaluating the capabilities model of dementia care: a non-randomized controlled trial exploring resident quality of life and care staff attitudes and experiences.

PubMed

Moyle, Wendy; Venturato, Lorraine; Cooke, Marie; Murfield, Jenny; Griffiths, Susan; Hughes, Julian; Wolf, Nathan

2016-07-01

This 12 month, Australian study sought to compare the Capabilities Model of Dementia Care (CMDC) with usual long-term care (LTC), in terms of (1) the effectiveness of the CMDC in assisting care staff to improve Quality Of Life (QOL) for older people with dementia; and (2) whether implementation of the CMDC improved staff attitudes towards, and experiences of working and caring for the person with dementia. A single blind, non-randomized controlled trial design, involving CMDC intervention group (three facilities) and a comparison usual LTC practice control group (one facility), was conducted from August 2010 to September 2011. Eighty-one staff members and 48 family members of a person with dementia were recruited from these four LTC facilities. At baseline, 6 and 12 months, staff completed a modified Staff Experiences of Working with Demented Residents questionnaire (SEWDR), and families completed the Quality of Life - Alzheimer's Disease questionnaire (QOL-AD). LTC staff in the usual care group reported significantly lower SEWDR scores (i.e. less work satisfaction) than those in the CMDC intervention group at 12 months (p = 0.005). Similarly, family members in the comparison group reported significantly lower levels of perceived QOL for their relative with dementia (QOL-AD scores) than their counterparts in the CMDC intervention group at 12 months (p = 0.012). Although the study has a number of limitations the CMDC appears to be an effective model of dementia care - more so than usual LTC practice. The CMDC requires further evaluation with participants from a diverse range of LTC facilities and stages of cognitive impairment.

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study.

PubMed

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p < 0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs' abilities to apply EBP knowledge and skills when supervising students.

Using Multiple Types of Studies in Systematic Reviews of Health Care Interventions – A Systematic Review

PubMed Central

Peinemann, Frank; Tushabe, Doreen Allen; Kleijnen, Jos

2013-01-01

Background A systematic review may evaluate different aspects of a health care intervention. To accommodate the evaluation of various research questions, the inclusion of more than one study design may be necessary. One aim of this study is to find and describe articles on methodological issues concerning the incorporation of multiple types of study designs in systematic reviews on health care interventions. Another aim is to evaluate methods studies that have assessed whether reported effects differ by study types. Methods and Findings We searched PubMed, the Cochrane Database of Systematic Reviews, and the Cochrane Methodology Register on 31 March 2012 and identified 42 articles that reported on the integration of single or multiple study designs in systematic reviews. We summarized the contents of the articles qualitatively and assessed theoretical and empirical evidence. We found that many examples of reviews incorporating multiple types of studies exist and that every study design can serve a specific purpose. The clinical questions of a systematic review determine the types of design that are necessary or sufficient to provide the best possible answers. In a second independent search, we identified 49 studies, 31 systematic reviews and 18 trials that compared the effect sizes between randomized and nonrandomized controlled trials, which were statistically different in 35%, and not different in 53%. Twelve percent of studies reported both, different and non-different effect sizes. Conclusions Different study designs addressing the same question yielded varying results, with differences in about half of all examples. The risk of presenting uncertain results without knowing for sure the direction and magnitude of the effect holds true for both nonrandomized and randomized controlled trials. The integration of multiple study designs in systematic reviews is required if patients should be informed on the many facets of patient relevant issues of health care interventions. PMID:24416098

Case-based learning and simulation: useful tools to enhance nurses' education? Nonrandomized controlled trial.

PubMed

Raurell-Torredà, Marta; Olivet-Pujol, Josep; Romero-Collado, Àngel; Malagon-Aguilera, Maria Carmen; Patiño-Masó, Josefina; Baltasar-Bagué, Alícia

2015-01-01

To compare skills acquired by undergraduate nursing students enrolled in a medical-surgical course. To compare skills demonstrated by students with no previous clinical practice (undergraduates) and nurses with clinical experience enrolled in continuing professional education (CPE). In a nonrandomized clinical trial, 101 undergraduates enrolled in the "Adult Patients 1" course were assigned to the traditional lecture and discussion (n = 66) or lecture and discussion plus case-based learning (n = 35) arm of the study; 59 CPE nurses constituted a comparison group to assess the effects of previous clinical experience on learning outcomes. Scores on an objective structured clinical examination (OSCE), using a human patient simulator and cases validated by the National League for Nursing, were compared for the undergraduate control and intervention groups, and for CPE nurses (Student's t test). Controls scored lower than the intervention group on patient assessment (6.3 ± 2.3 vs 7.5 ± 1.4, p = .04, mean difference, -1.2 [95% confidence interval (CI) -2.4 to -0.03]) but the intervention group did not differ from CPE nurses (7.5 ± 1.4 vs 8.8 ± 1.5, p = .06, mean difference, -1.3 [95% CI -2.6 to 0.04]). The CPE nurses committed more "rules-based errors" than did undergraduates, specifically patient identifications (77.2% vs 55%, p = .7) and checking allergies before administering medication (68.2% vs 60%, p = .1). The intervention group developed better patient assessment skills than the control group. Case-based learning helps to standardize the process, which can contribute to quality and consistency in practice: It is essential to correctly identify a problem in order to treat it. Clinical experience of CPE nurses was not associated with better adherence to safety protocols. Case-based learning improves the patient assessment skills of undergraduate nursing students, thereby preparing them for clinical practice. © 2014 Sigma Theta Tau International.

Impact of a Multifaceted and Clinically Integrated Training Program in Evidence-Based Practice on Knowledge, Skills, Beliefs and Behaviour among Clinical Instructors in Physiotherapy: A Non-Randomized Controlled Study

PubMed Central

Olsen, Nina Rydland; Bradley, Peter; Espehaug, Birgitte; Nortvedt, Monica Wammen; Lygren, Hildegunn; Frisk, Bente; Bjordal, Jan Magnus

2015-01-01

Background and Purpose Physiotherapists practicing at clinical placement sites assigned the role as clinical instructors (CIs), are responsible for supervising physiotherapy students. For CIs to role model evidence-based practice (EBP) they need EBP competence. The aim of this study was to assess the short and long term impact of a six-month multifaceted and clinically integrated training program in EBP on the knowledge, skills, beliefs and behaviour of CIs supervising physiotherapy students. Methods We invited 37 CIs to participate in this non-randomized controlled study. Three self-administered questionnaires were used pre- and post-intervention, and at six-month follow-up: 1) The Adapted Fresno test (AFT), 2) the EBP Belief Scale and 3) the EBP Implementation Scale. The analysis approach was linear regression modeling using Generalized Estimating Equations. Results In total, 29 CIs agreed to participate in the study: 14 were invited to participate in the intervention group and 15 were invited to participate in the control group. One in the intervention group and five in the control group were lost to follow-up. At follow-up, the group difference was statistically significant for the AFT (mean difference = 37, 95% CI (15.9 -58.1), p<0.001) and the EBP Beliefs scale (mean difference = 8.1, 95% CI (3.1 -13.2), p = 0.002), but not for the EBP Implementation scale (mean difference = 1.8. 95% CI (-4.5-8.1), p = 0.574). Comparing measurements over time, we found a statistically significant increase in mean scores related to all outcome measures for the intervention group only. Conclusions A multifaceted and clinically integrated training program in EBP was successful in improving EBP knowledge, skills and beliefs among CIs. Future studies need to ensure long-term EBP behaviour change, in addition to assessing CIs’ abilities to apply EBP knowledge and skills when supervising students. PMID:25894559

Ovule positions within linear fruit are correlated with nonrandom mating in Robinia pseudoacacia

PubMed Central

Yuan, Cunquan; Sun, Yuhan; Sun, Peng; Li, Yunfei; Hu, Ruiyang; Zhao, Keqi; Wang, Jinxing; Li, Yun

2016-01-01

Post-pollination processes can lead to nonrandom mating among compatible pollen donors. Moreover, morphological patterns of ovule development within linear fruits are reportedly nonrandom and depend on ovule position. However, little is known about the relationship between nonrandom mating and ovule position within linear fruit. Here, we combined controlled pollen competition experiments and paternity analyses on R. pseudoacacia to better understand nonrandom mating and its connection with ovule position. Molecular determination of siring success showed a significant departure from the expected ratio based on each kind of pollen mixture, suggesting a nonrandom mating. Outcrossed pollen grains, which were strongly favored, produced significantly more progeny than other pollen grains. Paternity analyses further revealed that the distribution of offspring produced by one specific pollen source was also nonrandom within linear fruit. The stylar end, which has a higher probability of maturation, produced a significantly higher number of outcrossed offspring than other offspring, suggesting a correlation between pollen source and ovule position. Our results suggested that a superior ovule position exists within the linear fruit in R. pseudoacacia, and the pollen that was strongly favored often preferentially occupies the ovules that were situated in a superior position, which ensured siring success and facilitated nonrandom mating. PMID:27819357

Physical Activity Interventions in Faith-Based Organizations: A Systematic Review.

PubMed

Tristão Parra, Maíra; Porfírio, Gustavo J M; Arredondo, Elva M; Atallah, Álvaro N

2018-03-01

To review and assess the effectiveness of physical activity interventions delivered in faith-based organizations. We searched the Cochrane Library, DoPHER, EMBASE, LILACS, MEDLINE, PsycINFO, WHO ICTRP, and Clinicaltrials.gov databases until January 2016, without restriction of language or publication date. Randomized and nonrandomized controlled trials investigating physical activity interventions for adults delivered in faith-based organizations. Two independent reviewers extracted data and assessed study methodological quality. We used relative risk and mean difference with 95% confidence interval to estimate the effect of the interventions on measures of physical activity, physical fitness, and health. The review included 18 studies. Study participants were predominantly female, and the majority of trials were conducted in the United States. Study heterogeneity did not allow us to conduct meta-analyses. Although interventions delivered in faith-based organizations increased physical activity and positively influenced measures of health and fitness in participants, the quality of the evidence was very low. Faith-based organizations are promising settings to promote physical activity, consequently addressing health disparities. However, high-quality randomized clinical trials are needed to adequately assess the effectiveness of interventions delivered in faith-based organizations.

Utility of a perioperative nutritional intervention on postoperative outcomes in high-risk head & neck cancer patients.

PubMed

Rowan, Nicholas R; Johnson, Jonas T; Fratangelo, Christina E; Smith, Brenda K; Kemerer, Patricia A; Ferris, Robert L

2016-03-01

Investigate both the utility and feasibility of perioperative nutritional supplementation with an arginine-enriched immunonutrition formula to high-risk head and neck cancer surgical patients and examine its effects on acute post-operative clinical outcomes. This prospective, non-randomized, interventional cohort study compared high-risk head and neck cancer surgical patients who consumed a pre- and post-operative arginine-based nutritional supplement to those that did not. Outcome measures included post-operative complications, length of hospitalization, readmission rates and measurement of nutritional biomarkers. 195 high-risk head and neck cancer surgical patients were enrolled. 59% of the patients used the nutritional supplement, 41% did not. Of the 80 patients who did not receive the immunonutrition formula, 38 (47.5%) experienced post-operative complications of all types as compared to 29 of the 115 (25.2%) patients who did consume the product (p=0.0021). Pharyngeal leaks or fistulas were the most common post-operative complications in both groups and more common in patients who did not receive supplementation (p=0.007). Length of stay was on average 2.8 days longer in patients who did not have enhanced nutrition (p=0.02), while readmission rates between the two groups were similar (p=0.91). Measurements of nutritional biomarkers were not reported secondary to low collection rates. Enhanced perioperative nutrition may result in significant reductions of post-operative fistula formations and decreased length of stay in a high-risk head and neck cancer population, even in the setting of poor compliance. The potential quality improvement in both patient care and healthcare cost is both real and significant. Copyright © 2016 Elsevier Ltd. All rights reserved.

Systematic review of β blocker, aspirin, and statin in critically ill patients: importance of severity of illness and cardiac troponin.

PubMed

Rothenberg, Florence G; Clay, Michael B; Jamali, Hina; Vandivier-Pletsch, Robin H

2017-04-01

Non-cardiac critically ill patients with type II myocardial infarction (MI) have a high risk of mortality. There are no evidence-based interventions to mitigate this risk. We systematically reviewed the literature regarding the use of medications known to reduce mortality in patients with cardiac troponin (cTn) elevation due to type I MI (β blockers, statin, and aspirin) in studies of critically ill patients without Type I MI. All PubMed publications between 1976-2/19/16 were reviewed. Search terms included: β blocker or aspirin or statin and intensive care unit (ICU) or critically ill or sepsis; 497 primary references were obtained. Inclusion criteria were as follows: (1) study population consisted of critically ill patients in the ICU with non-cardiovascular illnesses, (2) mortality end point, (3) severity of illness (or injury) was measured, and (4) the antiplatelet agent was primarily aspirin. Retrospective investigations, prospective observational studies, meta-analysis, systematic review, and randomized controlled trials were included; case reports were excluded. 25 primary references were obtained. The data were extracted and tabulated using data collection headings as follows: article title, first author/year/reference number, study type/design, population studied, outcome and intervention, and study question addressed. Evidence was not graded as the majority of studies were non-randomized (low-to-moderate quality). 11 studies were found through bibliography reviews for a total of 36 references. In conclusion, β blockers, statins, and aspirin may play a role in reducing mortality in non-cardiac critically ill patients. Benefit appears to be related to severity of illness, for which cTn may be a marker. Copyright © 2017 American Federation for Medical Research.

Pilot study evaluating the effect of massage therapy on stress, anxiety and aggression in a young adult psychiatric inpatient unit.

PubMed

Garner, Belinda; Phillips, Lisa J; Schmidt, Hans-Martin; Markulev, Connie; O'Connor, Jenny; Wood, Stephen J; Berger, Gregor E; Burnett, Peter; McGorry, Patrick D

2008-05-01

The aim of the present pilot study was to examine the effectiveness of a relaxation massage therapy programme in reducing stress, anxiety and aggression on a young adult psychiatric inpatient unit. This was a prospective, non-randomized intervention study comparing treatment as usual (TAU) with TAU plus massage therapy intervention (MT) over consecutive 7 week blocks (May-August 2006). MT consisted of a 20 min massage therapy session offered daily to patients during their period of hospitalization. The Kennedy Nurses' Observational Scale for Inpatient Evaluation (NOSIE), the Symptom Checklist-90-Revised (SCL-90-R), the State-Trait Anxiety Inventory (STAI) and stress hormone (saliva cortisol) levels were used to measure patient outcomes at admission and discharge from the unit. The Staff Observation Aggression Scale-Revised (SOAS-R) was used to monitor the frequency and severity of aggressive incidents on the unit. There was a significant reduction in self-reported anxiety (p < 0.001), resting heart rate (p < 0.05) and cortisol levels (p < 0.05) immediately following the initial and final massage therapy sessions. Significant improvements in hostility (p = 0.007) and depression scores (p < 0.001) on the SCL-90-R were observed in both treatment groups. There was no group x time interaction on any of the measures. Poor reliability of staff-reported incidents on the SOAS-R limited the validity of results in this domain. Massage therapy had immediate beneficial effects on anxiety-related measures and may be a useful de-escalating tool for reducing stress and anxiety in acutely hospitalized psychiatric patients. Study limitations preclude any definite conclusions on the effect of massage therapy on aggressive incidents in an acute psychiatric setting. Randomized controlled trials are warranted.

Clinical outcomes of atherectomy prior to percutaneous coronary intervention: A comparison of outcomes following rotational versus orbital atherectomy (COAP-PCI study).

PubMed

Meraj, Perwaiz M; Shlofmitz, Evan; Kaplan, Barry; Jauhar, Rajiv; Doshi, Rajkumar

2018-04-29

Because of the challenges in treating calcified coronary artery disease (CAD), lesion preparation has become increasingly important prior to percutaneous coronary intervention (PCI). Despite growing data for both rotational atherectomy (RA) and orbital atherectomy (OA), there have been no multicenter studies comparing the safety and efficacy of both. We sought to examine the clinical outcomes of patients with calcified CAD who underwent atherectomy. A total of 39 870 patients from five tertiary care hospitals who had PCI from January 2011 to January 2017 were identified. 907 patients who had RA or OA were included. This multicenter, prospectively collected observational analysis compared OA and RA. The primary end-point was myocardial infarction and safety outcomes including significant dissection, perforation, cardiac tamponade, and vascular complications. Propensity score matching (1:1) was performed to reduce selection bias. After matching, 546 patients were included in the final analysis. The primary endpoint, myocardial infarction occurred less frequently with OA compared to RA (6.7% vs 13.8%, P ≤ 0.01) in propensity score matched cohorts. Procedural safety outcomes were comparable between the groups. The secondary outcome of death on discharge occurred less in the OA group as compared with RA (0% vs 2.2%, P = 0.01). Fluoroscopy time was less in patients who were treated with OA (21.9 vs 25.6 min, P ≤ 0.01). Additional secondary outcomes were comparable between groups. In this non-randomized, multicenter comparison of contemporary atherectomy devices, OA was associated with significantly decreased in-hospital myocardial infarction and mortality after propensity score matching with decreased fluoroscopy time. © 2018, Wiley Periodicals, Inc.

Psychosocial Benefits of Cooking Interventions: A Systematic Review.

PubMed

Farmer, Nicole; Touchton-Leonard, Katherine; Ross, Alyson

2018-04-01

Cooking interventions are used in therapeutic and rehabilitative settings; however, little is known about the influence of these interventions on psychosocial outcomes. This systematic review examines the research evidence regarding the influence of cooking interventions on psychosocial outcomes. A systematic review of the literature examined peer-reviewed research using Embase, PubMed, CINALH Plus, and PsychInfo with the following search terms: cooking, culinary, baking, food preparation, cookery, occupational therapy, mental health, mood, psychosocial, affect, confidence, self-confidence, self-esteem, socialization, and rehabilitation. Inclusion criteria were the following: adults, English, influence of cooking interventions on psychosocial outcomes. PRISMA guidelines were used. The search yielded 377 articles; and 11 ultimately met inclusion criteria and were reviewed. Generally, the quality of the research was weak due to nonrandomization, unvalidated research tools, and small sample sizes. However, inpatient and community-based cooking interventions yielded positive influences on socialization, self-esteem, quality of life, and affect. Finding benefits to cooking that extend beyond nutritional may be helpful in increasing motivation and frequency of cooking. This review suggests that cooking interventions may positively influence psychosocial outcomes, although this evidence is preliminary and limited. Further qualitative and rigorous quantitative research are needed to identify mechanisms by which cooking interventions may improve psychosocial outcomes.

The efficacy of GMFM-88 and GMFM-66 to detect changes in gross motor function in children with cerebral palsy (CP): a literature review.

PubMed

Alotaibi, Madawi; Long, Toby; Kennedy, Elizabeth; Bavishi, Siddhi

2014-01-01

The purpose of this study was to review published research on the use of the Gross Motor Function Measure (GMFM-88) and (GMFM-66) as outcome measures to determine if these tools detect changes in gross motor function in children with cerebral palsy (CP) undergoing interventions. A comprehensive literature search was conducted using Medline and PubMed to identify studies published from January 2000 through January 2011 that reported the accuracy of GMFM-88 and GMFM-66 to measure changes over time in children with CP undergoing interventions. The keywords used for the search were "GMFM" and "CP". Two of the authors (M.A. and S.B.) reviewed the titles and abstracts found in the databases. The methodological quality of the studies was assessed by using the Critical Review Form-Quantitative Studies. Of 62 papers initially identified, 21 studies fulfilled the inclusion criteria. These articles consist of three longitudinal studies, six randomized controlled trials, four repeated measure design, six pre-post test design, a case series and one non-randomized prospective study. The included studies were generally of moderate to high methodological quality. The studies included children from a wide age range of 10 months to 16 years. According to the National Health and Medical Research Council, the study designs were level II, III-2, III-3 and IV. The review suggests that the GMFM-88 and GMFM-66 are useful as outcome measures to detect changes in gross motor function in children with CP undergoing interventions. Implications for Rehabilitation Accurate measurement of change in gross motor skill acquisition is important to determine effectiveness of intervention programs in children with cerebral palsy (CP). The Gross Motor Function Measure (GMFM-88 and GMFM-66) are common tools used by rehabilitation specialists to measure gross motor function in children with CP. The GMFM appears to be an effective outcome tool for measuring change in gross motor function according to a small number of randomized control studies utilizing participant populations of convenience.

Nutrition interventions for children aged less than 5 years following natural disasters: a systematic review protocol.

PubMed

Pradhan, Pranil Man Singh; Dhital, Rolina; Subhani, Huma

2015-11-30

Malnutrition among children is a serious public health problem in the aftermath of any natural disaster. We will review the various nutrition interventions for children aged <5 years in countries where natural disasters occurred and analyse the effect on nutrition-related outcomes. We will conduct a systematic review on nutrition intervention studies following natural disasters that were published between January 2000 and December 2015. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The Cochrane Risk of Bias (RoB) tool will be used for randomised controlled trials and Risk of Bias Assessment for Non-Randomized Studies (RoBANS) will be used for non-randomised studies. The quality of evidence will be assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines. If sufficient data are available, we will conduct meta-analyses to establish the relationship between nutrition interventions and nutrition outcome indicators. All statistical analyses will be performed using Review Manager (Rev Man) V.5.3 for Windows. Heterogeneity of the data will be tested using the standard χ(2) test. A fixed-effect model will be used for the studies with high heterogeneity (p value>0.10, I(2)≤50%). For dichotomous and continuous data, relative risk (RR) and mean difference with 95% CI will be used respectively. Subgroup analysis will be performed for studies with low heterogeneity (p value ≤0.10). We will use Z score with the level of significance set at p value <0.05 to test the total effect. Funnel plots will be used to detect publication bias. As primary data will not be collected, formal ethical approval will not be required. The results will be disseminated by publication in peer-reviewed journals, conference presentations and the media. International Prospective Register for Systematic Reviews (PROSPERO) number CRD42015023243 was registered on 1 June 2015. 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/

Efficacy of Health Education using Facebook to Promote Healthy Lifestyle among Medical Students in Puducherry, India: A Non-Randomized Controlled Trial

PubMed Central

Krishnamohan, Smrithi; Singh, Zile; Sridhar, Maghida

2017-01-01

Introduction Increasing burden of overweight and obesity among young adults is mainly due to unhealthy lifestyle especially with respect to diet and physical activity. At the same time, younger generations are spending more time with social network sites. Therefore, this study was intended to explore the role of social networking sites in promoting healthy lifestyle. Aim To measure the efficacy of health education using social networking sites in promoting healthy lifestyle among medical students in Puducherry, India. Materials and Methods A non-randomized controlled trial was conducted in a private medical college located in Puducherry. The study participants were overweight/obese individuals with (intervention arm) and without Facebook account (control arm). Following a baseline survey, both the groups received health education from dietician and physical trainer using Audiovisual (AV) aids. Intervention group received health education through Facebook in the forms of messages, pictures and videos for six weeks. Then, follow up survey was done to assess the change in dietary pattern, physical activity and body weight. Data of those who attended baseline, intervention and follow up surveys (23- control and 22- intervention) were analysed. Means and proportions were calculated. Paired t-test and Chi-square test were used to calculate the p-value. The p-value<0.05 was considered as statistically significant. Results Mean number of days of junk food intake per week was reduced in both control and intervention groups from 2.91 days/week and 3.27 days/week at baseline to 2.65 days/week to two days/week at follow up respectively. A significant decrease in the Body Mass Index (BMI) (p<0.05) was found among the control group (baseline: 25.57, follow up: 25.15). No significant changes were found with respect to physical activity and intake of fruits and vegetables. Conclusion Except for the decrease in junk food intake, use of Facebook as an effective tool to promote healthy lifestyle could not be proved with confidence. PMID:28892935

Prospective Nonrandomized Comparative Study of Laparoscopic Versus Open Surgical Staging for Endometrial Cancer in India.

PubMed

Ansar P P; Ayyappan S; Mahajan, Vikash

2018-06-01

Laparoscopic procedures to treat endometrial cancer are currently emerging. At present, we have evidence to do laparoscopic oncologic resections for endometrial cancer as proven by many prospective studies from abroad such as LAP2 by GOG. So, we have decided to assess the safety and feasibility of such a study in our population with the following as our primary objectives: (1) to study whether laparoscopy is better compared to open approach in terms of duration of hospital stay, perioperative morbidity and early recovery from surgical trauma and (2) to study whether the laparoscopic approach is noninferior to the open approach in terms of number of lymph nodes harvested in lymphadenectomy and rate of conversion to open surgery. We did a prospective nonrandomized comparative study of open versus laparoscopy approach for surgical staging of endometrial cancer from 16th May 2013 to 15th May 2015. To prove a significant difference in the hospital stay, we needed 29 patients in each arm. Thirty patients in each arm were enrolled for the study. The median duration of stay in the open arm was 7 days and in the laparoscopy arm it was 5 days. The advantage of 2 days in the laparoscopic arm was statistically significant ( P value 0.006). Forty percent of patients in the open arm had to stay in the hospital for more than 7 days whereas only 3% of patients in the laparoscopy arm required to stay for more than 7 days ( P value 0.001). This difference was statistically significant. There was no significant difference between the early complication rates between the two arms (20% in open vs. 13% in laparoscopy; P value 0.730). There was a conversion rate of 10% in laparoscopy. The median number of nodes harvested in open arm was 16.50 and in the laparoscopy arm, it was 13.50. The difference was not statistically significant ( P value 0.086). Laparoscopy approach for endometrial cancer staging is feasible in Indian patients and the short-term advantages are replicable with same oncologic safety as proved by randomized controlled trials.

Four years of immunization with OM-85 BV to prevent respiratory infections in HIV+ patients

PubMed Central

Capetti, Amedeo; Cossu, Maria Vittoria; Carenzi, Laura; Rizzardini, Giuliano

2013-01-01

We report an interventional, non-randomized experience of OM-85 BV immunization in a group of 104 HIV-infected subjects presenting recurrent seasonal respiratory bacterial infections. We compared the number of respiratory events, the use of antibiotics and the cost related to antibiotics before (2005–2006) and after (2008–2011) the introduction of such intervention. The year 2007 was excluded from the analysis since half of the patients were immunized in that year in an exploratory approach. Respiratory infections dropped in all groups but in subjects with recurrent otitis, leading to a reduction in the use of antibiotics. This is the first report of the effect of OM-85 BV in vivo in HIV-infected subjects. PMID:23792443

Implant Evaluation of an Insertable Cardiac Monitor Outside the Electrophysiology Lab Setting

PubMed Central

Pachulski, Roman; Cockrell, James; Solomon, Hemant; Yang, Fang; Rogers, John

2013-01-01

Background To date, insertable cardiac monitors (ICM) have been implanted in the hospital without critical evaluation of other potential settings. Providing alternatives to in-hospital insertion may increase access to ICM, decrease waiting times for patients awaiting diagnosis, and reduce hospital resources. Methods This was a prospective, non-randomized, clinical trial involving nine clinical sites throughout the United States designed to assess the feasibility of ICM implants in a non-hospital setting. Other than the Reveal® ICM, implant supplies and techniques were left to physician discretion in patients who met indications. Patients were followed up to 90 days post-implant. The primary objective was to characterize the number of procedure-related adverse events that required surgical intervention within 90 days. Results Sixty-five patients were implanted at nine out-of-hospital sites. The insertion procedure was well tolerated by all patients. There were no deaths, systemic infections or endocarditis. There were two (3%) procedure-related adverse events requiring device explant and four (6%) adverse events not requiring explant. ICM use led to 16 diagnoses (24.6%) with 9 patients proceeding to alternate cardiac device implants during the course of the 90-day follow up. Conclusion Out-of-hospital ICM insertion can be accomplished with comparable procedural safety and represents a reasonable alternative to the in-hospital setting. Clinicaltrials.gov registration number: NCT01168427 PMID:23977071

Burn, freeze, or photo-ablate?: comparative symptom profile in Barrett's dysplasia patients undergoing endoscopic ablation

NASA Astrophysics Data System (ADS)

Gill, Kanwar Rupinder S.; Gross, Seth A.; Greenwald, Bruce D.; Hemminger, Lois L.; Wolfsen, Herbert C.

2009-06-01

Background: There are few data available comparing endoscopic ablation methods for Barrett's esophagus with high-grade dysplasia (BE-HGD). Objective: To determine differences in symptoms and complications associated with endoscopic ablation. Design: Prospective observational study. Setting: Two tertiary care centers in USA. Patients: Consecutive patients with BE-HGD Interventions: In this pilot study, symptoms profile data were collected for BE-HGD patients among 3 endoscopic ablation methods: porfimer sodium photodynamic therapy, radiofrequency ablation and low-pressure liquid nitrogen spray cryotherapy. Main Outcome Measurements: Symptom profiles and complications from the procedures were assessed 1-8 weeks after treatment. Results: Ten BE-HGD patients were treated with each ablation modality (30 patients total; 25 men, median age: 69 years (range 53-81). All procedures were performed in the clinic setting and none required subsequent hospitalization. The most common symptoms among all therapies were chest pain, dysphagia and odynophagia. More patients (n=8) in the porfimer sodium photodynamic therapy group reported weight loss compared to radio-frequency ablactation (n=2) and cryotherapy (n=0). Four patients in the porfimer sodium photodynamic therapy group developed phototoxicity requiring medical treatment. Strictures, each requiring a single dilation, were found in radiofrequency ablactation (n=1) and porfimer sodium photodynamic therapy (n=2) patients. Limitations: Small sample size, non-randomized study. Conclusions: These three endoscopic therapies are associated with different types and severity of post-ablation symptoms and complications.

A New Sutureless Illuminated Macular Buckle Designed for Myopic Macular Hole Retinal Detachment

PubMed Central

Bedda, Ahmed M.; Lolah, Mohamed; Abd Al Shafy, Muhammad S.

2017-01-01

Purpose. To report the anatomic and visual results of a new sutureless illuminated macular buckle designed for patients with macular hole retinal detachment related to high myopia (MMHRD). Design. Prospective nonrandomized comparative interventional trial. Methods. Twenty myopic eyes of 20 patients (mean age, 51.4 years; range, 35–65 years) presenting with MMHRD with a posterior staphyloma, in whom the new buckle was used, were evaluated. The buckle used was assembled from a 5 mm wide sponge and a 7 mm wide silicone tire; it was fixed utilizing the sterile topical adhesive Histoacryl Blue (B Braun, TS1050044FP) which polymerizes in seconds upon being exposed to water-containing substances. The primary outcomes measured included aided visual acuity (BCVA) and optical coherence tomography (OCT) findings. The mean follow-up period was 6 months. Results. Postoperatively, the MH closure was identified by OCT in 8 (40%) eyes. The mean BCVA increased from 0.11 to 0.21 (p < 0.005). The axial length of the eyes included decreased from 30.5 mm preoperatively to 29.8 mm (p = 0.002) postoperatively. Conclusion. Preparation of the new sutureless macular buckle is simple and easy. Illumination of the terminal part of the buckle ensures proper placement. Histoacryl Blue is effective in fixing the buckle in its place for at least 6 months with no reported intra- or postoperative complications. PMID:28409023

Educational intervention for collecting sputum for tuberculosis: a quasi-experimental study 1

PubMed Central

Sicsú, Amélia Nunes; Salem, Julia Ignez; Fujimoto, Luciana Botinelly Mendonça; Gonzales, Roxana Isabel Cardozo; Cardoso, Maria do Socorro de Lucena; Palha, Pedro Fredemir

2016-01-01

Abstract Objective: to evaluate the quality of the sputum sample before and after the Nursing guidance to patients. Methods: this is a quasi-experimental research design, single group type, before and after, non-randomized study. The study enrolled patients with suspected pulmonary tuberculosis, respiratory symptomatic patients for over three weeks, aged over 18 years, of both genders and without tuberculosis history in the last two years. The educational intervention consisted of individualized guidance on the collection of sputum sample, which was based on the guidelines of the Ministry of Health of Brazil and on the explanatory folder delivery. Results: in this study participated 138 patients with suspected pulmonary tuberculosis. The results showed significant increase of the samples with purulent particles, volume greater than 5 mL and increased rate of patients diagnosed with tuberculosis, after the educational intervention. Conclusion: it was shown that after the educational intervention, it was observed sputum samples with better quality, with satisfactory aspect and volume for the effectiveness of the bacilloscopic examination. PMID:27276015

Is It the Intervention or the Students? Using Linear Regression to Control for Student Characteristics in Undergraduate STEM Education Research

PubMed Central

Theobald, Roddy; Freeman, Scott

2014-01-01

Although researchers in undergraduate science, technology, engineering, and mathematics education are currently using several methods to analyze learning gains from pre- and posttest data, the most commonly used approaches have significant shortcomings. Chief among these is the inability to distinguish whether differences in learning gains are due to the effect of an instructional intervention or to differences in student characteristics when students cannot be assigned to control and treatment groups at random. Using pre- and posttest scores from an introductory biology course, we illustrate how the methods currently in wide use can lead to erroneous conclusions, and how multiple linear regression offers an effective framework for distinguishing the impact of an instructional intervention from the impact of student characteristics on test score gains. In general, we recommend that researchers always use student-level regression models that control for possible differences in student ability and preparation to estimate the effect of any nonrandomized instructional intervention on student performance. PMID:24591502

Is it the intervention or the students? using linear regression to control for student characteristics in undergraduate STEM education research.

PubMed

Theobald, Roddy; Freeman, Scott

2014-01-01

Although researchers in undergraduate science, technology, engineering, and mathematics education are currently using several methods to analyze learning gains from pre- and posttest data, the most commonly used approaches have significant shortcomings. Chief among these is the inability to distinguish whether differences in learning gains are due to the effect of an instructional intervention or to differences in student characteristics when students cannot be assigned to control and treatment groups at random. Using pre- and posttest scores from an introductory biology course, we illustrate how the methods currently in wide use can lead to erroneous conclusions, and how multiple linear regression offers an effective framework for distinguishing the impact of an instructional intervention from the impact of student characteristics on test score gains. In general, we recommend that researchers always use student-level regression models that control for possible differences in student ability and preparation to estimate the effect of any nonrandomized instructional intervention on student performance.

Promoting motor skills in low-income, ethnic children: The Physical Activity in Linguistically Diverse Communities (PALDC) nonrandomized trial.

PubMed

Okely, Anthony D; Hardy, Louise L; Batterham, Marijka; Pearson, Phillip; McKeen, Kim; Puglisi, Lauren

2017-11-01

This study reports the long-term effects of a professional learning program for classroom teachers on fundamental motor skill (FMS) proficiency of primary school students from ethnically diverse backgrounds. A cluster non-randomized trial using a nested cross-sectional design. The study was conducted in 8 primary schools located in disadvantaged and culturally diverse areas in Sydney, Australia. The intervention used an action learning framework, with each school developing and implementing an action plan for enhancing the teaching of FMS in their school. School teams comprised 4-5 teachers and were supported by a member of the research team. The primary outcome was total proficiency score for 7 FMS (run, jump, catch, throw, kick, leap, side gallop). Outcome data were analyzed using mixed effects models. Eight-hundred and sixty-two students (82% response rate) were assessed at baseline in 2006 and 830 (82%) at follow-up in 2010. Compared with students in the control schools, there was a significantly greater increase in total motor skill proficiency among children in the intervention schools at follow-up (adjusted difference=5.2 components, 95%CI [1.65, 8.75]; p=0.01) and in four of the seven motor skills. Training classroom teachers to develop and implement units of work based around individual FMS is a promising strategy for increasing FMS among ethnically diverse children over an extended period of time. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

The Use and Interpretation of Quasi-Experimental Studies in Medical Informatics

PubMed Central

Harris, Anthony D.; McGregor, Jessina C.; Perencevich, Eli N.; Furuno, Jon P.; Zhu, Jingkun; Peterson, Dan E.; Finkelstein, Joseph

2006-01-01

Quasi-experimental study designs, often described as nonrandomized, pre-post intervention studies, are common in the medical informatics literature. Yet little has been written about the benefits and limitations of the quasi-experimental approach as applied to informatics studies. This paper outlines a relative hierarchy and nomenclature of quasi-experimental study designs that is applicable to medical informatics intervention studies. In addition, the authors performed a systematic review of two medical informatics journals, the Journal of the American Medical Informatics Association (JAMIA) and the International Journal of Medical Informatics (IJMI), to determine the number of quasi-experimental studies published and how the studies are classified on the above-mentioned relative hierarchy. They hope that future medical informatics studies will implement higher level quasi-experimental study designs that yield more convincing evidence for causal links between medical informatics interventions and outcomes. PMID:16221933

Social support in pregnancy: the 'soft' way to increase birthweight?

PubMed

Oakley, A

1985-01-01

This paper examines the thesis that social support in pregnancy is capable of affecting birthweight as one easily measurable aspect of pregnancy outcome. The focus of the paper is on birthweight, since low birthweight is a relatively stable and important factor in social inequalities in perinatal health. The paper reviews the published literature on social support in pregnancy including simple observational and nonrandomized intervention studies and also randomized controlled trials of 'social' interventions. The methodological problems associated with some of these studies are discussed. However, it is concluded that there is considerable evidence to suggest that intervention programmes aimed at improving the 'social' side of antenatal care are capable of affecting birthweight and other 'hard' measures of pregnancy outcome. It is suggested that traditional professional approaches to pregnancy which divide the medical from the social perspective, have acted to prevent recognition of this evidence and its relevance to maternity care policy.

Interventions to promote or improve the mental health of primary care nurses: a systematic review.

PubMed

Duhoux, Arnaud; Menear, Matthew; Charron, Maude; Lavoie-Tremblay, Mélanie; Alderson, Marie

2017-11-01

To synthesize the evidence on the effectiveness of interventions aiming to promote or improve the mental health of primary care nurses. Primary care nurses have been found to have high levels of emotional exhaustion and to be at increased risk of suffering from burnout, anxiety and depression. Given the increasingly critical role of nurses in high-performing primary care, there is a need to identify interventions that can effectively reduce these professionals' mental health problems and promote their well-being. We conducted a systematic review on the effectiveness of interventions at the individual, group, work environment or organizational level. Eight articles reporting on seven unique studies met all eligibility criteria. They were non-randomized pre-post intervention studies and reported positive impacts of interventions on at least some outcomes, though caution is warranted in interpreting these results given the moderate-weak methodological quality of studies. This systematic review found moderate-weak evidence that primary, secondary and combined interventions can reduce burnout and stress in nurses practising in community-based health care settings. The results highlight a need for the implementation and evaluation of new strategies tailored for community-based nurses practising in primary care. © 2017 John Wiley & Sons Ltd.

The effects of a life goal-setting technique in a preventive care program for frail community-dwelling older people: a cluster nonrandomized controlled trial.

PubMed

Yuri, Yoshimi; Takabatake, Shinichi; Nishikawa, Tomoko; Oka, Mari; Fujiwara, Taro

2016-05-12

Frailty among older people is associated with an increased risk of needing care. There have been many reports on preventive care programs for frail older people, but few have shown positive effects on disability prevention. Physical exercise programs for frail older people affect elements such as physical fitness and balance, but are less effective for disability outcomes and are not followed up in the longer term. We developed a life goal-setting technique (LGST). Our objective was to determine the effect of a LGST plus standard preventive care program for community-dwelling frail older people. We used a cluster nonrandomized controlled trial with seven intervention and nine matched control groups, with baseline assessment and follow-up at 3, 6, and 9 months. Participants were 176 frail older people, aged 65 years or over, living in the community in Izumi, Osaka, Japan. All participants attended regular 120 min preventive care exercise classes each week, over 3 months. They also received oral care and nutrition education. The intervention groups alone received life goal-setting support. We assessed outcomes longitudinally, comparing pre-intervention with follow-up. The primary outcome measure was health improvement according to the Japanese Ministry of Health, Labour and Welfare's "Kihon Checklist" for assessment of frailty and quality of life (QOL), analyzed with a two-way ANOVA and post-test comparison. Secondary outcomes included physical functions and assessment of life goals. The improvement on the Kihon Checklist for the intervention group was approximately 60 % from baseline to 9-months follow-up; the control group improved by approximately 40 %. The difference between groups was significant at 3-month (p = 0.043) and 6-month (p = 0.015) follow-ups but not at 9-month (p = 0.098) follow-up. Analysis of QOL yielded a significant time × group interaction effect (p = 0.022). The effect was significant at 3 months in the intervention group, but at no time in the control group. A 3-month exercise program helped to decrease frailty and improve QOL in frail older people, and the addition of LGST increased its effectiveness. The LGST is a feasible and promising intervention for reducing risk of needing care. UMIN000021485 . Registered 15 March 2016.

Pharyngocutaneous fistula after total laryngectomy: Less common with mechanical stapler closure.

PubMed

Calli, Caglar; Pinar, Ercan; Oncel, Semih

2011-05-01

The aim of the study was to compare the incidences of pharyngocutaneous fistula after total laryngectomy between patients who underwent manual and mechanical suturing for pharyngoesophageal closure. In a retrospective and prospective nonrandomized clinical study conducted at a single tertiary medical center between May 2002 and April 2009, we compared the incidence of pharyngocutaneous salivary fistula between two groups of patients after total laryngectomy. Sixty-one consecutive patients who underwent mechanical suturing with a 60-mm linear stapler (group A) were prospectively enrolled, and 121 patients who had undergone manual suturing (group B) were retrospectively reviewed. The groups were similar in terms of age, gender, comorbidities, TNM (tumor, node, metastasis) stage, and laryngeal tumor extension. The incidence of pharyngocutaneous salivary fistula was 4.9% in group A and 19.8% in group B (p = 0.014). Mechanical stapler closure of the pharynx after total laryngectomy was associated with a significant reduction in the incidence of pharyngocutaneous fistula compared with manual suture in selected cases.

The Role of Prospective Memory in Medication Adherence: A Review of an Emerging Literature

PubMed Central

Zogg, Jennifer B.; Woods, Steven Paul; Sauceda, John A.; Wiebe, John S.; Simoni, Jane M.

2013-01-01

Although neurocognitive impairment is an established risk factor for medication non-adherence, standard neurocognitive tests developed for clinical purposes may not fully capture the complexities of non-adherence behavior or effectively inform theory-driven interventions. Prospective memory, an innovative cognitive construct describing one’s ability to remember to do something at a later time, is an understudied factor in the detection and remediation of medication non-adherence. This review orients researchers to the construct of prospective memory, summarizes empirical evidence for prospective memory as a risk factor for non-adherence, discusses the relative merits of current measurement techniques, and highlights potential prospective memory-focused intervention strategies. A comprehensive literature review was conducted of published empirical studies investigating prospective memory and medication adherence. Overall, reviewed studies suggest that prospective memory is an important component of medication adherence, providing incremental ecological validity over established predictors. Findings indicate that prospective memory-based interventions might be an effective means of improving adherence. PMID:21487722

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

PubMed

Wetzel, F Todd; McNally, Thomas A; Phillips, Frank M

2002-11-15

Retrospective literature review. To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

A Systematic Narrative Review of Effects of Community-Based Intervention on Rates of Organ Donor Registration.

PubMed

Golding, Sarah Elizabeth; Cropley, Mark

2017-09-01

The demand for organ donation is increasing worldwide. One possible way of increasing the pool of potential posthumous donors is to encourage more members of the general public to join an organ donor registry. A systematic review was conducted to investigate the effectiveness of psychological interventions designed to increase the number of individuals in the community who register as organ donors. PsycINFO and PubMed databases were searched. No date limits were set. Randomized and nonrandomized controlled trials exploring the effects of community-based interventions on organ donor registration rates were included. Methodological quality was assessed using the "Quality Assessment Tool for Quantitative Studies." Twenty-four studies met the inclusion criteria; 19 studies found a positive intervention effect on registration. Only 8 studies were assessed as having reasonable methodological robustness. A narrative synthesis was conducted. Factors influencing registration rates include providing an immediate registration opportunity and using brief interventions to challenge misconceptions and concerns about organ donation. Community-based interventions can be effective at increasing organ donor registrations among the general public. Factors that may increase effectiveness include brief interventions to address concerns and providing an immediate registration opportunity. Particular consideration should be paid to the fidelity of intervention delivery. Protocol registration number: CRD42014012975.

A sexy spin on nonrandom chromosome segregation.

PubMed

Charville, Gregory W; Rando, Thomas A

2013-06-06

Nonrandom chromosome segregation is an intriguing phenomenon linked to certain asymmetric stem cell divisions. In a recent report in Nature, Yadlapalli and Yamashita (2013) observe nonrandom segregation of X and Y chromosomes in Drosophila germline stem cells and shed light on the complex mechanisms of this fascinating process. Copyright © 2013 Elsevier Inc. All rights reserved.

Developing Prospective Elementary Teachers' Abilities to Identify Evidence of Student Mathematical Achievement

ERIC Educational Resources Information Center

Spitzer, Sandy M.; Phelps, Christine M.; Beyers, James E. R.; Johnson, Delayne Y.; Sieminski, Elizabeth M.

2011-01-01

This study investigated the effects of a classroom intervention on prospective elementary teachers' ability to evaluate evidence of student achievement of mathematical learning goals. The intervention was informed by a framework for teacher education which aims to provide prospective teachers (PTs) with the skills needed to systematically learn…

Random Versus Nonrandom Peer Review: A Case for More Meaningful Peer Review.

PubMed

Itri, Jason N; Donithan, Adam; Patel, Sohil H

2018-05-10

Random peer review programs are not optimized to discover cases with diagnostic error and thus have inherent limitations with respect to educational and quality improvement value. Nonrandom peer review offers an alternative approach in which diagnostic error cases are targeted for collection during routine clinical practice. The objective of this study was to compare error cases identified through random and nonrandom peer review approaches at an academic center. During the 1-year study period, the number of discrepancy cases and score of discrepancy were determined from each approach. The nonrandom peer review process collected 190 cases, of which 60 were scored as 2 (minor discrepancy), 94 as 3 (significant discrepancy), and 36 as 4 (major discrepancy). In the random peer review process, 1,690 cases were reviewed, of which 1,646 were scored as 1 (no discrepancy), 44 were scored as 2 (minor discrepancy), and none were scored as 3 or 4. Several teaching lessons and quality improvement measures were developed as a result of analysis of error cases collected through the nonrandom peer review process. Our experience supports the implementation of nonrandom peer review as a replacement to random peer review, with nonrandom peer review serving as a more effective method for collecting diagnostic error cases with educational and quality improvement value. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Radiation exposure to eye lens and operator hands during endovascular procedures in hybrid operating rooms.

PubMed

Attigah, Nicolas; Oikonomou, Kyriakos; Hinz, Ulf; Knoch, Thomas; Demirel, Serdar; Verhoeven, Eric; Böckler, Dittmar

2016-01-01

The purpose of this study was to evaluate the radiation exposure of vascular surgeons' eye lens and fingers during complex endovascular procedures in modern hybrid operating rooms. Prospective, nonrandomized multicenter study design. One hundred seventy-one consecutive patients (138 male; median age, 72.5 years [interquartile range, 65-77 years]) underwent an endovascular procedure in a hybrid operating room between March 2012 and July 2013 in two vascular centers. The dose-area product (DAP), fluoroscopy time, operating time, and amount of contrast dye were registered prospectively. For radiation dose recordings, single-use dosimeters were attached at eye level and to the ring finger of the hand next to the radiation field of the operator for each endovascular procedure. Dose recordings were evaluated by an independent institution. Before the study, precursory investigations were obtained to simulate the radiation dose to eye lens and fingers with an Alderson phantome (RSD, Long Beach, Calif). Interventions were classified into six treatment categories: endovascular repair of infrarenal abdominal aneurysm (n = 65), thoracic endovascular aortic repair (n = 32), branched endovascular aortic repair for thoracoabdominal aneurysms (n = 17), fenestrated endovascular aortic repair for complex abdominal aortic aneurysm, (n = 25), iliac branched device (n = 8), and peripheral interventions (n = 24). There was a significant correlation in DAP between both lens (P < .01; r = 0.55) and finger (P < .01; r = 0.56) doses. The estimated fluoroscopy time to reach a radiation threshold of 20 mSv/y was 1404.10 minutes (90% confidence limit, 1160, 1650 minutes). According to correlation of the lens dose with the DAP an estimated cumulative DAP of 932,000 mGy/m(2) (90% confidence limit, 822,000, 1,039,000) would be critical for a threshold of 20 mSv/y for the eyes. Radiation protection is a serious issue for vascular surgeons because most complex endovascular procedures are delivering measurable radiation to the eyes. With the correlation of the DAP obtained in standard endovascular procedures a critical threshold of 20 mSv/y to the eyes can be predicted and thus an estimate of a potential harmful exposure to the eyes can be obtained. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up.

PubMed

Hagatun, Susanne; Vedaa, Øystein; Nordgreen, Tine; Smith, Otto R F; Pallesen, Ståle; Havik, Odd E; Bjorvatn, Bjørn; Thorndike, Frances P; Ritterband, Lee M; Sivertsen, Børge

2017-03-27

Insomnia is a major health problem, and the need for effective and accessible treatment is urgent. The aim of the current study was to evaluate the short-term efficacy of an unguided Internet-based cognitive-behavioral treatment program for insomnia (CBTi), called SHUTi (Sleep Healthy Using the Internet). This study used a parallel arm randomized controlled trial in Norway. Participants were randomly allocated to the SHUTi condition or a Web-based patient education condition. Both groups were assessed before and after the nine-week intervention period (online sleep diaries and questionnaires). The SHUTi participants were reassessed in a six-month nonrandomized follow-up. Primary outcome measures were the Insomnia Severity Index (ISI) and the Bergen Insomnia Scale (BIS). A total of 181 participants were included in the study; SHUTi condition (n = 95), patient education condition (n = 86). Intention-to-treat mixed-model repeated-measures analysis revealed that the SHUTi group had better short-term outcomes compared with the patient education group on most sleep measures. The SHUTi group showed a significant decrease on the primary outcomes, the ISI (d between = -1.77, 95% CI = -2.23, -1.31) and the BIS (d between = -1.00, 95% CI = -1.32, -.68). Improvements were maintained among the completing SHUTi participants at the six-month nonrandomized follow-up. However, dropout attrition was high. Unguided Internet-based CBTi produced significant short-term improvements in sleep in patients with chronic insomnia. This highlights the benefits of making Internet-delivered CBTi programs available as a standard first-line treatment option in public health services. Nevertheless, the rate of dropout attrition (participants not completing post-assessment) in this trial limits the generalizability of the findings.

A prospective, multicenter study of a double stent system for palliative treatment of malignant extrahepatic biliary obstructions.

PubMed

Kim, Jong Woo; Gwon, Dong Il; Han, Young-Min; Won, Je Hwan; Hong, Hyun Pyo; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo

2015-10-01

A double stent system (covered stent in uncovered stent) was designed to provide long-term patency without tumor ingrowth or stent-related complications, such as stent migration, cholecystitis, or pancreatitis. To investigate the safety and efficacy of double stents in patients with malignant extrahepatic biliary obstructions. This prospective, nonrandomized, multicenter study enrolled 160 consecutive patients (102 men; mean age, 64 years; range, 33-91 years) with malignant extrahepatic biliary obstructions treated with a double stent system from January 2010 to March 2012. The technical success rate of the double stent placement was 100%. No stent migration was observed. Procedure-related minor (self-limiting hemobilia [n = 6] and cholangitis [n = 2]) and major (pancreatitis [n = 16], cholecystitis [n = 3], and hepatic abscess [n = 2]) complications occurred in a total of 29 patients. The mean serum bilirubin level, which was 8.9 ± 5.6 mg/dL before drainage, decreased to 2.2 ± 4.6 mg/dL 1 month after stent placement (P < 0.001). Successful internal drainage was achieved in 148 patients (92.5%). During the mean follow-up period of 205 days, acute cholecystitis (n = 3) and hepatic abscess (n = 2) occurred in five patients. The median patient survival and stent patency time were 135 days (95% confidence interval [CI], 96-160 days) and 114 days (95% CI, 83-131 days), respectively. Of 153 patients, 22 (14.4%) presented with stent dysfunction due to sludge incrustation (n = 17), tumor overgrowth (n = 4), or blood clot (n = 1), and required repeat intervention. Tumor ingrowth was not observed in any of these patients. Percutaneous treatment of malignant extrahepatic biliary obstruction using a double stent safely and effectively achieves internal biliary drainage. © The Foundation Acta Radiologica 2014.

Non-randomized intervention study of naloxone co-prescription for primary care patients on long-term opioid therapy for pain

PubMed Central

Coffin, Phillip O.; Behar, Emily; Rowe, Christopher; Santos, Glenn-Milo; Coffa, Diana; Bald, Matthew; Vittinghoff, Eric

2018-01-01

Background Unintentional overdose involving opioid analgesics is a leading cause of injury-related death in the United States. Objectives To evaluate the feasibility and impact of implementing naloxone prescription to patients prescribed opioids for chronic pain. Design 2-year non-randomized intervention study. Setting 6 safety net primary care clinics in San Francisco. Participants 1985 adults receiving long-term opioids for pain. Intervention Providers and clinic staff were trained and supported in naloxone prescribing. Measurements Outcomes were proportion of patients prescribed naloxone, opioid-related emergency department (ED) visits, and prescribed opioid dose based on chart review. Results 38.2% of 1,985 patients on long-term opioids were prescribed naloxone. Patients on higher doses of opioids and with a past 12-month opioid-related emergency department (ED) visit were independently more likely to be prescribed naloxone. Patients who received a naloxone prescription had 47% fewer opioid-related ED visits per month six months after the receipt of the prescription (IRR=0.53, 95%CI=0.34–0.83, P=0.005) and 63% fewer visits after one year (IRR=0.37, 95%CI=0.22–0.64, P<0.001), compared to patients who did not receive naloxone. There was no net change over time in opioid dose among those who received naloxone compared to those who did not (IRR 1.03, 95% CI 0.91–1.27, P = 0.61). Limitations Results are observational and may not be generalizable beyond safety net settings. Conclusion Naloxone can be co-prescribed to primary care patients prescribed opioids for pain. When advised to offer naloxone to all patients on opioids, providers may prioritize those with established risk factors. Providing naloxone in primary care settings may have ancillary benefits such as reducing opioid-related adverse events. Funding Source National Institutes of Health grant R21DA036776 PMID:27366987

Physical activity interventions in children and young people with Type 1 diabetes mellitus: a systematic review with meta-analysis.

PubMed

Quirk, H; Blake, H; Tennyson, R; Randell, T L; Glazebrook, C

2014-10-01

To synthesize evidence from randomized and non-randomized studies of physical activity interventions in children and young people with Type 1 diabetes so as to explore clinically relevant health outcomes and inform the promotion of physical activity. We conducted a search of CINAHL Plus, the Cochrane Library, EMBASE, MEDLINE, PsycINFO, SCOPUS, SportDiscus and Web of Science between October and December 2012. Eligible articles included subjects aged ≤18 years with Type 1 diabetes and a physical activity intervention that was more than a one-off activity session. Physiological, psychological, behavioural or social outcomes were those of interest. A total of 26 articles (10 randomized and 16 non-randomized studies), published in the period 1964-2012, were reviewed. Although there was heterogeneity in study design, methods and reporting, 23 articles reported at least one significant beneficial health outcome at follow-up. Meta-analyses of these studies showed potential benefits of physical activity on HbA1c (11 studies, 345 participants, standardized mean difference -0.52, 95% CI -0.97 to -0.07; P = 0.02), BMI (four studies, 195 participants, standardized mean difference -0.41, 95% CI -0.70 to -0.12; P = 0.006) and triglycerides (five studies, 206 participants, standardized mean difference -0.70, 95% CI -1.25 to -0.14; P = 0.01).The largest effect size was for total cholesterol (five studies, 206 participants, standardized mean difference -0.91, 95% CI -1.66 to -0.17; P = 0.02). Physical activity is important for diabetes management and has the potential to delay cardiovascular disease, but there is a lack of studies that are underpinned by psychological behaviour change theory, promoting sustained physical activity and exploring psychological outcomes. There remains a lack of knowledge of how to promote physical activity in people with Type 1 diabetes. © 2014 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Gamification and Microlearning for Engagement With Quality Improvement (GAMEQI): A Bundled Digital Intervention for the Prevention of Central Line-Associated Bloodstream Infection.

PubMed

Orwoll, Benjamin; Diane, Shelley; Henry, Duncan; Tsang, Lisa; Chu, Kristin; Meer, Carrie; Hartman, Kevin; Roy-Burman, Arup

Central line-associated bloodstream infections (CLABSIs) cause major patient harm, preventable through attention to line care best practice standards. The objective was to determine if a digital self-assessment application (CLABSI App), bundling line care best practices with social gamification and in-context microlearning, could engage nurses in CLABSI prevention. Nurses caring for children with indwelling central venous catheters in 3 high-risk units were eligible to participate. All other units served as controls. The intervention was a 12-month nonrandomized quality improvement study of CLABSI App implementation with interunit competitions. Compared to the preceding year, the intervention group (9886 line days) CLABSI rate decreased by 48% ( P = .03). Controls (7879 line days) did not change significantly. In all, 105 unique intervention group nurses completed 673 self-assessments. Competitions were associated with increased engagement as measured by self-assessments and unique participants. This model could be extended to other health care-associated infections, and more broadly to process improvement within and across health care systems.

A systematic review of the evidence on home care reablement services.

PubMed

Legg, Lynn; Gladman, John; Drummond, Avril; Davidson, Alex

2016-08-01

To determine whether publically funded 'reablement services' have any effect on patient health or use of services. Systematic review of randomized controlled trials and non-randomized studies in which reablement interventions were compared with no care or usual care in people referred to public-funded personal care services. Data sources included: Cochrane Central Register of Controlled Trials, EPOC register of studies, trials registers, Medline, EMBASE, and CINHAL. Searches were from 2000 up to end February 2015. Not applicable. Investigators' definition of the target population for reablement interventions. Use of publically funded personal care services and dependence in personal activities of daily living. We found no studies fulfilling our inclusion criteria that assessed the effectiveness of reablement interventions. We did note the lack of an agreed understanding of the nature of reablement. Reablement is an ill-defined intervention targeted towards an ill-defined and potentially highly heterogeneous population/patient group. There is no evidence to suggest it is effective at either of its goals; increasing personal independence or reducing use of personal care services. © The Author(s) 2015.

The incident user design in comparative effectiveness research.

PubMed

Johnson, Eric S; Bartman, Barbara A; Briesacher, Becky A; Fleming, Neil S; Gerhard, Tobias; Kornegay, Cynthia J; Nourjah, Parivash; Sauer, Brian; Schumock, Glen T; Sedrakyan, Art; Stürmer, Til; West, Suzanne L; Schneeweiss, Sebastian

2013-01-01

Comparative effectiveness research includes cohort studies and registries of interventions. When investigators design such studies, how important is it to follow patients from the day they initiated treatment with the study interventions? Our article considers this question and related issues to start a dialogue on the value of the incident user design in comparative effectiveness research. By incident user design, we mean a study that sets the cohort's inception date according to patients' new use of an intervention. In contrast, most epidemiologic studies enroll patients who were currently or recently using an intervention when follow-up began. We take the incident user design as a reasonable default strategy because it reduces biases that can impact non-randomized studies, especially when investigators use healthcare databases. We review case studies where investigators have explored the consequences of designing a cohort study by restricting to incident users, but most of the discussion has been informed by expert opinion, not by systematic evidence. Published 2012. This article is a U.S. Government work and is in the public domain in the USA.

Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review

PubMed Central

2013-01-01

Background Mobile phone text messaging (SMS) has the potential to promote adherence to tuberculosis treatment. This systematic review aims to synthesize current evidence on the effectiveness of SMS interventions in improving patients’ adherence to tuberculosis treatment. Methods We searched electronic databases (PubMed, EMBASE, Science Citation Index), reference lists of relevant articles, conference proceedings, and selected websites for eligible studies available by 15 February 2013; regardless of language or publication status. Two authors independently screened selected eligible studies, and assessed risk of bias in included studies; resolving discrepancies by discussion and consensus. Results We identified four studies that compared the outcomes of the SMS intervention group with controls. Only one of the four studies was a randomized controlled trial. This was conducted in Argentina and the SMS intervention did not significantly improve adherence to tuberculosis treatment compared to self-administration of tuberculosis treatment (risk ratio [RR] 1.49, 95% confidence intervals [CI] 0.90 to 2.42). One of the non-randomized studies, conducted in South Africa, which compared SMS reminders to directly observed therapy short course (DOTS) reported similar rates of tuberculosis cure (62.35% vs. 66.4%) and treatment success (72.94% vs. 69.4%). A second study from South Africa, utilized SMS reminders when patients delayed in opening their pill bottles and reported increased tuberculosis cure (RR 2.32, 95% CI 1.60 to 3.36) and smear conversion (RR 1.62, 95% CI 1.09 to 2.42) rates compared to DOTS. In the third non-randomized study, conducted in Kenya, use of SMS reminders increased rates of clinic attendance on scheduled days compared to standard care (RR 1.56, 95% CI 1.06 to 2.29). Using the GRADE approach, we rate the quality of the evidence as low, mainly because of the high risk of bias and heterogeneity of effects across studies. Conclusions This systematic review indicates that there is a paucity of high-quality data on the effectiveness of SMS interventions for improving patients’ adherence to tuberculosis treatment. The low quality of the current evidence implies that further studies (in particular randomized trials) on the subject are needed. In the interim, if the intervention is implemented outside research settings an impact evaluation is warranted. PMID:24295439

An Education Intervention to Enhance Staff Self-Efficacy to Provide Dementia Care in an Acute Care Hospital in Canada

PubMed Central

Gillies, Leslie; Coker, Esther; Pizzacalla, Anne; Montemuro, Maureen; Suva, Grace; McLelland, Victoria

2016-01-01

Education is needed for enhanced capacity of acute hospitals to provide dementia care. A nonrandomized controlled, repeated-measures design was used to evaluate a dementia education program delivered to an intervention group (IG, n = 468), compared to a wait-listed group (n = 277), representing separate sites of a multisite hospital. Participants completed self-efficacy for dementia and satisfaction measures and provided written descriptions of dementia care collected at baseline, postintervention (IG only), and at 8-week follow-up. Oral narratives were gathered from IG participants 8 weeks postintervention. The IG demonstrated significant improvement in self-efficacy scores from baseline to immediately postintervention (P < .001), sustained at 8 weeks. There were no changes from baseline to 8 weeks postintervention evident in the wait-listed group (P = .21). Intervention group participants described positive impacts including implementation of person-centered care approaches. Implementation of dementia care education programs throughout hospital settings is promising for the enhancement of dementia care. PMID:27659392

A foot-care program to facilitate self-care by the elderly: a non-randomized intervention study.

PubMed

Omote, Shizuko; Watanabe, Arisu; Hiramatsu, Tomoko; Saito, Emiko; Yokogawa, Masami; Okamoto, Rie; Sakakibara, Chiaki; Ichimori, Akie; Kyota, Kaoru; Tsukasaki, Keiko

2017-11-09

We aimed to evaluate a foot-care awareness program designed to improve foot morphology, physical functioning, and fall prevention among the community-dwelling elderly. Eleven independent community-dwelling elderly women (aged 61-83 years) were provided with foot-care advice and shown effective foot-care techniques to perform regularly for 6 months, and compared with a control group of 10 elderly women who did not receive any intervention. Measurements of foot form, functional capacity, subjective foot movement, and physical function were taken at baseline and 6-month follow-up. At follow-up, improvements were seen in the intervention group in foot morphology, subjective foot movement, foot pressure, and balance. In the intervention group, 90% of women had maintained or improved foot form and none of them had fallen during the post-intervention period, compared to the control group where 30% improved foot form (p = 0.0075) and four (40%) of them had fallen. Therefore, a foot-care program may have the potential to prevent falls and improve mobility among the elderly. Trial Registration UMIN-CTR No. UMIN000029632. Date of Registration: October 19, 2017.

Conjunctival autografting combined with low-dose mitomycin C for prevention of primary pterygium recurrence.

PubMed

Frucht-Pery, Joseph; Raiskup, Frederic; Ilsar, Michael; Landau, David; Orucov, Faik; Solomon, Abraham

2006-06-01

To compare the clinical outcome of pterygium surgery combining intraoperative mitomycin C (MMC) with a free conjunctival autograft, with three other methods of pterygium surgery, including intraoperative MMC alone, conjunctival autograft alone, and bare sclera without adjunctive treatment. Interventional, randomized and in part nonrandomized, prospective, comparative study. setting: A university medical center department of ophthalmology. One hundred and twenty patients underwent pterygium excision surgery. These patients were divided into four treatment groups. In group 1 (30 patients), MMC, 0.2 mg/ml, was applied for three minutes. In group 2 (30 patients), conjunctival autografting was performed. Group 3 (30 patients) received sodium chloride 0.9% only, and group 4 (30 patients) underwent conjunctival autografting combined with one minute application of MMC, 0.2 mg/ml. Recurrence rates and complications. Pterygium recurred in two patients (6.6%) in group 1, in four patients (13.3%) in group 2, in 14 patients (46.6%) in group 3, and in none of the patients in group 4. chi(2) analysis revealed a significantly lower recurrence rate in group 4 compared with group 2 (P = .038) and with group 3 (P < .0001). Epithelialization of the wounds was complete within 14 days of surgery. No complications were demonstrated in any of the study groups except for one case of minor melting of the flap in group 4. This study indicates that pterygium excision with a free conjunctival autograft combined with intraoperative low-dose MMC is a safe and effective technique in pterygium surgery.

Feasibility and Efficacy of Nurse-Driven Acute Stroke Care.

PubMed

Mainali, Shraddha; Stutzman, Sonja; Sengupta, Samarpita; Dirickson, Amanda; Riise, Laura; Jones, Donald; Yang, Julian; Olson, DaiWai M

2017-05-01

Acute stroke care requires rapid assessment and intervention. Replacing traditional sequential algorithms in stroke care with parallel processing using telestroke consultation could be useful in the management of acute stroke patients. The purpose of this study was to assess the feasibility of a nurse-driven acute stroke protocol using a parallel processing model. This is a prospective, nonrandomized, feasibility study of a quality improvement initiative. Stroke team members had a 1-month training phase, and then the protocol was implemented for 6 months and data were collected on a "run-sheet." The primary outcome of this study was to determine if a nurse-driven acute stroke protocol is feasible and assists in decreasing door to needle (intravenous tissue plasminogen activator [IV-tPA]) times. Of the 153 stroke patients seen during the protocol implementation phase, 57 were designated as "level 1" (symptom onset <4.5 hours) strokes requiring acute stroke management. Among these strokes, 78% were nurse-driven, and 75% of the telestroke encounters were also nurse-driven. The average door to computerized tomography time was significantly reduced in nurse-driven codes (38.9 minutes versus 24.4 minutes; P < .04). The use of a nurse-driven protocol is feasible and effective. When used in conjunction with a telestroke specialist, it may be of value in improving patient outcomes by decreasing the time for door to decision for IV-tPA. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Ultrastructural effects of silicone oil on the clear crystalline lens of the human eye.

PubMed

Soliman, Wael; Sharaf, Mohamed; Abdelazeem, Khaled; El-Gamal, Dalia; Nafady, Allam

2018-03-01

To evaluate light and electron microscopic changes of the anterior capsule and its epithelium after clear lens extraction of vitrectomized myopic eyes with silicone oil tamponade. This prospective, controlled, non-randomized, interventional study included 20 anterior lens capsular specimens that were excised during combined clear lens extraction and silicone oil removal from previously vitrectomized highly myopic patients with silicone oil tamponade for previous retinal detachment surgeries. The specimens were examined via light microscopy and electron microscopy and compared with 20 anterior capsule specimens removed during clear lens extraction of non-vitrectomized highly myopic eyes. Light microscopic examination of clear lens anterior capsule specimens of vitrectomized myopic eyes filled with silicone oil showed relatively more flat cells with irregular outline of lens' epithelial cells with wide intercellular spaces, deeply stained nuclei, and multiple intracytoplasmic vacuoles. Scanning electron microscopy revealed collagenous surfaces filled with multiple pits, depressions, and abnormal deposits. Transmission electron microscopy revealed lens epithelial cells with apoptotic changes, many cytoplasmic vacuoles, and filopodia-like protrusions between lens epithelial cells and the capsule. Epithelial proliferation and multilayering were also observed. silicone oil may play a role in the development of apoptotic and histopathological changes in clear lens epithelial cells. Clarity of the lens at the time of silicone oil removal does not indicate an absence of cataractous changes. We found justification of combined clear lens extraction and silicone oil removal or combined phacovitrectomy when silicone oil injection is planned, but further long-term studies with larger patient groups are required.

Do moderate aerobic exercise and strength training influence electromyographic biofeedback of the pelvic floor muscles in female non-athletes?

PubMed Central

Gonçalves, Maria Lucia Campos; Fernandes, Samantha; Batista de Sousa, João

2018-01-01

[Purpose] To assess the influence of moderate physical exercise on pelvic floor muscle electromyographic (EMG) biofeedback signal in female non-athletes. [Subjects and Methods] A prospective, non-randomized study of 90 adult females (age ≥18 years) divided into three groups: Intervention (I), which began physical exercise upon study enrollment; Moderate Exercise (ME), comprising those who already engaged in physical activity; and Sedentary (S), comprising those who had a sedentary lifestyle. All participants underwent EMG biofeedback of the pelvic floor muscles upon study enrollment (T1) and at the end of the third subsequent month (T2). [Results] Mean age was 35.7 (SD: 7.5) years, with no significant difference between groups. T1 values in groups I and S were significantly lower than in group ME. There was no statistically significant difference between groups S and I. On comparison between groups at T2, values were highest in group I (18.5 µV vs. 15.3 µV in group S, vs. 16.1 µV in group ME). There was no significant difference between groups S and ME. On age-adjusted analysis, group I exhibited the greatest change between T1 and T2 (I, 4.7 µV; ME, 2.1 µV; S, 1.5 µV). [Conclusion] Females who exercise exhibit better pelvic floor muscle function than those who do not engage in physical activity. PMID:29545703

Health disorders related to learning the welding trade: assessment of approaches to risk communication.

PubMed

Bonow, Clarice Alves; Cezar-Vaz, Marta Regina; Silva, Lauro Roberto Witt da; Rocha, Laurelize Pereira; Turik, Claudia

2014-01-01

to assess the identification of health disorders as self-reported by apprentices of welding and to analyze the strength of the relationship between age and time of experience with self-reported health disorders before and after a socio-environmental nursing intervention. this quasi-experimental, non-randomized, before-and-after study was conducted with 86 welding apprentices from a private entity. the results show a significant difference for the pre- and post-test means and an increase in the post-test mean score for the cardiovascular, respiratory and cutaneous systems. There was also a negative correlation between the apprentices' ages and the identification of health disorders. the socio-environmental nursing intervention enabled obtaining information on health disorders related to welding. In turn, such information enabled the apprentices to assess information and self-report health disorders.

Multidisciplinary management of very advanced stage III and IV melanoma: Proof-of-principle.

PubMed

Gutman, Haim; Ben-Ami, Eytan; Shapira-Frommer, Roni; Schachter, Jacob

2012-08-01

Patients with potentially resectable advanced stage III and IV melanoma are a selected subgroup that gain maximal advantage if treated in a melanoma center. Surgery combined with chemo/chemobiotherapy may yield durable remission and long-term palliation. Thirty-seven non-randomly selected patients underwent systemic therapy with the aim of consolidating treatment by surgery. Data were collected prospectively, and analyzed retrospectively. The median follow-up from diagnosis was 50 (3-307) months and 15 (1-156) months when calculated from the last intervention. Twenty-two males and 15 females, with a median age at diagnosis of 44 (20-71) years, with 13 trunk, 13 extremity, 3 head and neck and 8 unknown primary melanomas were included. There were 17 stage III and 20 stage IV patients with a median Breslow thickness of 3.7 (0.45-26) mm. Chemo/chemobiotherapy achieved 7 clinical complete responses (cCRs), 28 partial responses (PRs) and 2 instances of stable disease. Six of the 7 cCRs were operated on, securing pathological complete response in 5 and PR in one. Four of these five and the PR patient still have no evidence of disease (NED). Twenty-one of 30 PR patients were rendered NED by surgery; 14 of these 21 patients succumbed to melanoma, and one is alive with stable disease. Overall, 11 of 37 patients have not succumbed to melanoma, with a median of 72 (14-156) months survival following the last intervention. Of the eight patients with unknown primary melanomas, five have not succumbed to melanoma, with a median of 89 (30-156) months survival following the last intervention. Patients with marginally resectable stage III and IV melanoma have a significant 30% chance, according to this series, for durable remission if treated by a multidisciplinary team in a melanoma center using induction chemobiotherapy and surgery. Results are more favorable for patients with an unknown primary lesion. In view of the currently approved new effective treatments for melanoma, this study may be considered a proof-of-principle investigation, enabling long-term remissions by combining induction therapy and surgery.

Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review

PubMed Central

Chambers, Duncan; Bagnall, Anne-Marie; Hempel, Susanne; Forbes, Carol

2006-01-01

Objectives To determine whether any particular intervention or combination of interventions is effective in the treatment, management and rehabilitation of adults and children with a diagnosis of chronic fatigue syndrome / myalgic encephalomyelitis (CFS/ME). Design Substantive update of a systematic review published in 2002. Randomized (RCTs) and non-randomized controlled trials of any intervention or combination of interventions were eligible for inclusion. Study participants could be adults or children with a diagnosis of CFS/ME based on any criteria. We searched eleven electronic databases, reference lists of articles and reviews, and textbooks on CFS/ME. Additional references were sought by contact with experts. Results Seventy studies met the inclusion criteria. Studies on behavioural, immunological, pharmacological and complementary therapies, nutritional supplements and miscellaneous other interventions were identified. Graded exercise therapy and cognitive behaviour therapy appeared to reduce symptoms and improve function based on evidence from RCTs. For most other interventions, evidence of effectiveness was inconclusive and some interventions were associated with significant adverse effects. Conclusions Over the last five years, there has been a marked increase in the size and quality of the evidence base on interventions for CFS/ME. Some behavioural interventions have shown promising results in reducing the symptoms of CFS/ME and improving physical functioning. There is a need for research to define the characteristics of patients who would benefit from specific interventions and to develop clinically relevant objective outcome measures. PMID:17021301

Video feedback for families of hearing impaired children.

PubMed

Santos, Ingrid Rafaella Dantas Dos; Brazorotto, Joseli Soares

2018-03-05

In order to improve speech-language development in children with hearing impairment, in addition to speech-language therapy, the family should be the modifying agent for a satisfactory therapeutic response. Studies that analyze the effectiveness of speech-language pathology (SLP) intervention programs through video feedback are important, given the positive effects of this tool on the modification of behaviors with families of children with disabilities. Therefore, it is believed that video feedback interventions contribute improve the communicative interactions between the families and children assisted by auditory rehabilitation services. The objectives of this study were to investigate the interaction between families and children with hearing loss and analyze the self-esteem and satisfaction of families before and after the intervention program. This is a non-randomized, clinical trial with case report in two groups: Experimental (n=5) and Control (n=5). The intervention was supported by family-child interaction videos and adapted instruments. Pre- and post-intervention protocols were applied. In the EG, improvement was observed in the interaction between the families and children with hearing loss and in the self-esteem of participants. The EG showed satisfaction with the intervention. We conclude that the SLP intervention program based on video feedback has positive effects on the family/child interaction and on parent self-esteem. Further studies with stricter methodological controls should be conducted to prove the efficacy of video feedback intervention for families of children with hearing loss.

Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

PubMed

Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

2018-01-01

Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

Text Messaging: An Intervention to Increase Physical Activity among African American Participants in a Faith-Based, Competitive Weight Loss Program.

PubMed

McCoy, Pamela; Leggett, Sophia; Bhuiyan, Azad; Brown, David; Frye, Patricia; Williams, Bryman

2017-03-29

African American adults are less likely to meet the recommended physical activity guidelines for aerobic and muscle-strengthening activity than Caucasian adults. The purpose of this study was to assess whether a text message intervention would increase physical activity in this population. This pilot study used a pre-/post-questionnaire non-randomized design. Participants in a faith-based weight loss competition who agreed to participate in the text messaging were assigned to the intervention group ( n = 52). Participants who declined to participate in the intervention, but agreed to participate in the study, were assigned to the control group ( n = 30). The text messages provided strategies for increasing physical activity and were based on constructs of the Health Belief Model and the Information-Motivation-Behavioral Skills Model. Chi square tests determined the intervention group participants increased exercise time by approximately eight percent ( p = 0.03), while the control group's exercise time remained constant. The intervention group increased walking and running. The control group increased running. Most participants indicated that the health text messages were effective. The results of this pilot study suggest that text messaging may be an effective method for providing options for motivating individuals to increase physical activity.

Text Messaging: An Intervention to Increase Physical Activity among African American Participants in a Faith-Based, Competitive Weight Loss Program

PubMed Central

McCoy, Pamela; Leggett, Sophia; Bhuiyan, Azad; Brown, David; Frye, Patricia; Williams, Bryman

2017-01-01

African American adults are less likely to meet the recommended physical activity guidelines for aerobic and muscle-strengthening activity than Caucasian adults. The purpose of this study was to assess whether a text message intervention would increase physical activity in this population. This pilot study used a pre-/post-questionnaire non-randomized design. Participants in a faith-based weight loss competition who agreed to participate in the text messaging were assigned to the intervention group (n = 52). Participants who declined to participate in the intervention, but agreed to participate in the study, were assigned to the control group (n = 30). The text messages provided strategies for increasing physical activity and were based on constructs of the Health Belief Model and the Information-Motivation-Behavioral Skills Model. Chi square tests determined the intervention group participants increased exercise time by approximately eight percent (p = 0.03), while the control group’s exercise time remained constant. The intervention group increased walking and running. The control group increased running. Most participants indicated that the health text messages were effective. The results of this pilot study suggest that text messaging may be an effective method for providing options for motivating individuals to increase physical activity. PMID:28353650

Interventions to reduce accidents in childhood: a systematic review.

PubMed

Barcelos, Raquel S; Del-Ponte, Bianca; Santos, Iná S

2017-12-30

To review the literature on interventions planned to prevent the incidence of injuries in childhood. The PubMed, Web of Science, and Bireme databases were searched by two independent reviewers, employing the single terms accidents, accident, injuries, injury, clinical trial, intervention, educational intervention, and multiple interventions, and their combinations, present in the article title or abstract, with no limits except period of publication (2006-2016) and studies in human subjects. Initially, 11,097 titles were located. Fifteen articles were selected for the review. Eleven were randomized trials (four carried out at the children's households, five in pediatric healthcare services, and two at schools), and four were non-randomized trials carried out at the children's households. Four of the randomized trials were analyzed by intention-to-treat and a protective effect of the intervention was observed: decrease in the number of risk factors, decrease in the number of medical consultations due to injuries, decrease in the prevalence of risk behaviors, and increase of the parents' knowledge regarding injury prevention in childhood. Traumatic injuries in childhood are amenable to primary prevention through strategies that consider the child's age and level of development, as well as structural aspects of the environment. Copyright © 2017 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Challenging mental health related stigma in China: Systematic review and meta-analysis. II. Interventions among people with mental illness.

PubMed

Xu, Ziyan; Huang, Fangfang; Kösters, Markus; Rüsch, Nicolas

2017-09-01

People with mental illness often face different types of mental illness stigma that may affect their lives, including perceived stigma, self-stigma, harmful coping strategies and poor quality of life. Although anti-stigma interventions for people with mental illness from Western countries have been identified by recent systematic reviews, their efficacy in China is unknown. This review evaluates the efficacy of anti-stigma interventions among people with mental illness in Mainland China, Hong Kong, Taiwan and Macau. A systematic search of 8 electronic databases in English and Chinese yielded 17 randomized and non-randomized controlled trials. Standardized mean differences (SMDs) were calculated wherever possible. Psychoeducation was the most commonly used intervention. SMDs were large and significant for perceived/experienced/anticipated stigma, self-prejudice and coping with stigma, as well as for depression and anxiety symptoms and quality of life. Both Cognitive Behavioral Therapy and psychoeducation had positive effects on perceived/experienced/anticipated stigma. The quality of studies was modest and heterogeneity across studies was high. Anti-stigma interventions demonstrated promise to reduce stigma's negative impact on people with mental illness in China, but more high-quality intervention research is needed. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The IDEFICS intervention trial to prevent childhood obesity: design and study methods.

PubMed

Pigeot, I; Baranowski, T; De Henauw, S

2015-12-01

One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.

[Studies on occupational stress intervention in workplaces abroad: a systematic review].

PubMed

Hua, Yujie; Dai, Junming

2015-10-01

To evaluate the effects of occupational stress intervention in the workplaces abroad by systematic review and to provide a reference for domestic research. The Medline database was searched to collect the literature on occupational stress intervention published from January 1 in 2000 to September 4 in 2014, Using standardized forms, the methods, contents, subjects, study design, result indicator, effectiveness and evidence of the intervention were extracted and analyzed. Thirty studies met the inclusion criteria, with a total sample size of 5699 participants, including 20 randomized trials and 10 non-randomized or self-controlled studies from 12 countries, such as Germany, Japan, and Britain. The course of intervention ranged from 4 to 16 weeks. Six types of intervention were identified, i.e., cognitive-behavioral treatment (CBT), relaxation technique, physical activity, organization-focused intervention, combined intervention, and multilevel intervention, among which CBT was used most frequently. The outcome variables mainly included social psychological variable and work-related variable. Occupational stress intervention could significantly improve the occupational stress and depressive symptoms, and also had some effects on the work-related outcomes. The effectiveness of the intervention might vary between the subjects with different occupational stress levels before intervention. The effectiveness of the intervention was better at an organizational level than at an individual level, but the effectiveness at a multiple level was not necessarily better than that at a single level. Occupational stress intervention is an effective method to improve the occupational stress at workplace. However, the occupational stress level before intervention, the duration and frequency of intervention, measures and level of intervention, and follow-up period have certain influence on the effectiveness of intervention. Future research should pay attention to methodology, focus on organizational level and network-based intervention, and increase the cost-benefit analysis.

Efficacy and safety of a porcine collagen sponge for cranial neurosurgery: a prospective case-control study.

PubMed

Brandão, Rafael Augusto Castro Santiago; Costa, Bruno Silva; Dellaretti, Marcos Antonio; de Carvalho, Gervásio Teles C; Faria, Marcello Penholate; de Sousa, Atos Alves

2013-01-01

The use of dural grafts is very useful when primary dural closure cannot be achieved. Our primary objective was to study the incidence of postoperative cerebrospinal fluid leak, including fistula and pseudomeningocele, and postoperative infection by comparing autologous material and a new collagen graft. A prospective nonrandomized study with a new collagen-based product derived from porcine cells (Peridry) was performed. It was used for dural replacement in 50 patients who underwent a variety of neurosurgical procedures requiring the use of a dural graft. These results were compared with a control group of 50 patients who were treated with autologous duraplasty material. The follow-up period was 3 months. Postoperative overall cerebrospinal fluid fistula occurred in 6% of both groups. No patient in the collagen group developed any sort of infection. One patient in the control developed osteomyelitis in the bone flap. The new collagen-based product derived from porcine cells (Peridry), compared with an autologous tissue, is safe, effective, easy to use, as well as time saving in cranial neurosurgery. Copyright © 2013 Elsevier Inc. All rights reserved.

Hysterectomy for complications after uterine artery embolization for leiomyoma: results of a Canadian multicenter clinical trial.

PubMed

Pron, Gaylene; Mocarski, Eva; Cohen, Marsha; Colgan, Terence; Bennett, John; Common, Andrew; Vilos, George; Kung, Rose

2003-02-01

To determine the complication-related hysterectomy rate after uterine artery embolization (UAE) for symptomatic uterine leiomyomas. Prospective, multicenter, nonrandomized, single-arm clinical trial (Canadian Task Force classification II-2). Eight Ontario University-affiliated teaching and community hospitals. Five hundred fifty-five women. Polyvinyl alcohol particles were delivered through a catheter into uterine arteries under fluoroscopic guidance. Prospective follow-up investigations consisted of telephone interviews, ultrasound examinations, and reviews of pathology and surgery reports. Median follow-up was 8.1 months, and all but five patients had complete 3-month follow-up. At 3 months, eight women (1.5%, 95% CI 0.6-2.8) underwent complication-related hysterectomy. Half of the surgeries were performed at institutions other than where UAE had been performed. Indications for hysterectomies were infections (2), postembolization pain (4), vaginal bleeding (1), and prolapsed leiomyoma (1). The 3-month complication rate resulting in hysterectomy after UAE in a large cohort of women was low. Hysterectomy after UAE is an important measure of safety and a key outcome measure of this new therapy.

Balancing between bleeding and thromboembolism after percutaneous coronary intervention in patients with atrial fibrillation. Could triple anticoagulant therapy be a solution?

PubMed

Dąbrowska, Magdalena; Ochała, Andrzej; Cybulski, Wiesław; Tendera, Michał

2013-01-01

Atrial fibrillation (AF) has nowadays become a common disease as it comes along with medical procedures propagation in the ageing population with coexistent diseases. Hence a need for use of combined anticoagulant and antithrombotic therapy has arisen. According to the 2010 ESC guidelines on myocardial revascularization, short-term triple antithrombotic therapy after percutaneous coronary intervention (PCI) should be given if compelling indications exist. To assess bleeding and thromboembolic events depending on the antithrombotic regimen in short- and long-term follow-up in patients with AF after PCI with stent implantation. A 12-month prospective, non-randomized registry was conducted in the 3(rd) Department of Cardiology in the Upper Silesian Medical Center in Katowice from October 2008 to April 2011. One hundred and four patients in two groups - on triple therapy (TT; aspirin + clopidogrel + vitamin K antagonists (VKA; warfarin or acenocoumarol) n = 44) and on dual therapy (DT; aspirin + clopidogrel; n = 60) - were assessed 30 days and 12 months after angioplasty. All bleeding events occurred more often in the triple anticoagulated group in 30 days (TT 20.5% vs. DT 6.7%; p = 0.03) and after 12 months (TT 38.9% vs. DT 17.2%, p = 0.09). The difference in major bleeding events was not significant after 30 days (TT 9.1% vs. DT 3.3%; p = NS) or 12 months (TT 11.1% vs. DT 6.9%; p = NS). Thromboembolic events after 30 days (DT 5.0% vs. TT 2.3%) and 12 months (TT 11.1% vs. DT 3.4%) were comparable. The percentage of deaths after 30 days (DT 1.7% vs. TT 0.0%, p = NS) increased after 12 months (DT 13.8% vs. TT 0.0%, p = 0.09). Significantly higher risk of bleeding on TT becomes blurred by a tendency to increased mortality in patients on DT.

Mindfulness Training for Health Profession Students-The Effect of Mindfulness Training on Psychological Well-Being, Learning and Clinical Performance of Health Professional Students: A Systematic Review of Randomized and Non-randomized Controlled Trials.

PubMed

McConville, Janet; McAleer, Rachael; Hahne, Andrew

High levels of stress have been identified in medical students and increasingly in other health profession student population groups. As stress can affect psychological well-being and interfere with learning and clinical performance, there is a clear argument for universities to include health professional student well-being as an outcome in core curriculum. Mindfulness training is a potential construct to manage stress and enhance academic success. The aims of this systematic review were to assess the effectiveness of mindfulness training in medical and other health professional student population groups and to compare the effectiveness of the different mindfulness-based programs. A literature search was completed using The Cochrane library, Medline, Cinahl, Embase, Psychinfo, and ERIC (proquest) electronic databases from inception to June 2016. Randomized and non-randomized controlled trials were included. Of the potential 5355 articles, 19 met the inclusion criteria. Studies focused on medical (n = 10), nursing (n = 4), social work (n = 1), psychology (n = 1), and medical plus other health (n = 3) students. Interventions were based on mindfulness. The 19 studies included 1815 participants. Meta-analysis was performed evaluating the effect of mindfulness training on mindfulness, anxiety, depression, stress, mood, self-efficacy, and empathy. The effect of mindfulness on academic performance was discussed. Mindfulness-based interventions decrease stress, anxiety, and depression and improve mindfulness, mood, self-efficacy, and empathy in health profession students. Due to the range of presentation options, mindfulness training can be relatively easily adapted and integrated into health professional training programs. Copyright © 2017 Elsevier Inc. All rights reserved.

Use of simulation-based education to improve outcomes of central venous catheterization: a systematic review and meta-analysis.

PubMed

Ma, Irene W Y; Brindle, Mary E; Ronksley, Paul E; Lorenzetti, Diane L; Sauve, Reg S; Ghali, William A

2011-09-01

Central venous catheterization (CVC) is increasingly taught by simulation. The authors reviewed the literature on the effects of simulation training in CVC on learner and clinical outcomes. The authors searched computerized databases (1950 to May 2010), reference lists, and considered studies with a control group (without simulation education intervention). Two independent assessors reviewed the retrieved citations. Independent data abstraction was performed on study design, study quality score, learner characteristics, sample size, components of interventional curriculum, outcomes assessed, and method of assessment. Learner outcomes included performance measures on simulators, knowledge, and confidence. Patient outcomes included number of needle passes, arterial puncture, pneumothorax, and catheter-related infections. Twenty studies were identified. Simulation-based education was associated with significant improvements in learner outcomes: performance on simulators (standardized mean difference [SMD] 0.60 [95% CI 0.45 to 0.76]), knowledge (SMD 0.60 [95% CI 0.35 to 0.84]), and confidence (SMD 0.41 [95% CI 0.30 to 0.53] for studies with single-group pretest and posttest design; SMD 0.52 (95% CI 0.23 to 0.81) for studies with nonrandomized, two-group design). Furthermore, simulation-based education was associated with improved patient outcomes, including fewer needle passes (SMD -0.58 [95% CI -0.95 to -0.20]), and pneumothorax (relative risk 0.62 [95% CI 0.40 to 0.97]), for studies with nonrandomized, two-group design. However, simulation-based training was not associated with a significant reduction in risk of either arterial puncture or catheter-related infections. Despite some limitations in the literature reviewed, evidence suggests that simulation-based education for CVC provides benefits in learner and select clinical outcomes.

Increasing capacity to deliver diabetes self-management education: results of the DESMOND lay educator non-randomized controlled equivalence trial.

PubMed

Carey, M E; Mandalia, P K; Daly, H; Gray, L J; Hale, R; Martin Stacey, L; Taub, N; Skinner, T C; Stone, M; Heller, S; Khunti, K; Davies, M J

2014-11-01

To develop and test a format of delivery of diabetes self-management education by paired professional and lay educators. We conducted an equivalence trial with non-randomized participant allocation to a Diabetes Education and Self Management for Ongoing and Newly Diagnosed Type 2 diabetes (DESMOND) course, delivered in the standard format by two trained healthcare professional educators (to the control group) or by one trained lay educator and one professional educator (to the intervention group). A total of 260 people with Type 2 diabetes diagnosed within the previous 12 months were referred for self-management education as part of routine care and attended either a control or intervention format DESMOND course. The primary outcome measure was change in illness coherence score (derived from the Diabetes Illness Perception Questionnaire-Revised) between baseline and 4 months after attending education sessions. Secondary outcome measures included change in HbA1c level. The trial was conducted in four primary care organizations across England and Scotland. The 95% CI for the between-group difference in positive change in coherence scores was within the pre-set limits of equivalence (difference = 0.22, 95% CI 1.07 to 1.52). Equivalent changes related to secondary outcome measures were also observed, including equivalent reductions in HbA1c levels. Diabetes education delivered jointly by a trained lay person and a healthcare professional educator with the same educator role can provide equivalent patient benefits. This could provide a method that increases capacity, maintains quality and is cost-effective, while increasing access to self-management education. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

The comparative effectiveness of a team-based versus group-based physical activity intervention for cancer survivors.

PubMed

Carter, Cindy L; Onicescu, Georgiana; Cartmell, Kathleen B; Sterba, Katherine R; Tomsic, James; Alberg, Anthony J

2012-08-01

Physical activity benefits cancer survivors, but the comparative effectiveness of a team-based delivery approach remains unexplored. The hypothesis tested was that a team-based physical activity intervention delivery approach has added physical and psychological benefits compared to a group-based approach. A team-based sport accessible to survivors is dragon boating, which requires no previous experience and allows for diverse skill levels. In a non-randomized trial, cancer survivors chose between two similarly structured 8-week programs, a dragon boat paddling team (n = 68) or group-based walking program (n = 52). Three separate intervention rounds were carried out in 2007-2008. Pre-post testing measured physical and psychosocial outcomes. Compared to walkers, paddlers had significantly greater (all p < 0.01) team cohesion, program adherence/attendance, and increased upper-body strength. For quality-of-life outcomes, both interventions were associated with pre-post improvements, but with no clear-cut pattern of between-intervention differences. These hypothesis-generating findings suggest that a short-term, team-based physical activity program (dragon boat paddling) was associated with increased cohesion and adherence/attendance. Improvements in physical fitness and psychosocial benefits were comparable to a traditional, group-based walking program. Compared to a group-based intervention delivery format, the team-based intervention delivery format holds promise for promoting physical activity program adherence/attendance in cancer survivors.

Quality improvement of interdisciplinary rounds by leadership training based on essential quality indicators of the Interdisciplinary Rounds Assessment Scale.

PubMed

Ten Have, Elsbeth C M; Nap, Raoul E; Tulleken, Jaap E

2013-10-01

The implementation of interdisciplinary teams in the intensive care unit (ICU) has focused attention on leadership behavior. Daily interdisciplinary rounds (IDRs) in ICUs integrate leadership behavior and interdisciplinary teamwork. The purpose of this intervention study was to measure the effect of leadership training on the quality of IDRs in the ICU. A nonrandomized intervention study was conducted in four ICUs for adults. The intervention was a 1-day training session in a simulation environment and workplace-based feedback sessions. Measurement included 28 videotaped IDRs (total, 297 patient presentations) that were assessed with 10 essential quality indicators of the validated IDR Assessment Scale. Participants were 19 intensivists who previously had no formal training in leading IDRs. They were subdivided by cluster sampling into a control group (ten experienced intensivists) and intervention group (nine intensive care fellows). Mann-Whitney U test was used to compare results between control and intervention groups. Baseline measurements of control and intervention groups revealed two indicators that differed significantly. The frequency of yes ratings for the intervention group significantly increased for seven of the ten indicators from before to after intervention. The frequency of yes ratings after training was significantly greater in the intervention than control groups for eight of the ten essential quality indicators. The leadership training improved the quality of the IDRs performed in the ICUs. This may improve quality and safety of patient care.

Propofol and non-propofol based sedation for outpatient colonoscopy-prospective comparison of depth of sedation using an EEG based SEDLine monitor.

PubMed

Goudra, Basavana; Singh, Preet Mohinder; Gouda, Gowri; Borle, Anuradha; Carlin, Augustus; Yadwad, Avantika

2016-10-01

Propofol is a popular anesthetic sedative employed in colonoscopy. It is known to increase the patient satisfaction and improve throughput. However, there are concerns among the clinicians with regard to the depth of sedation, as a deeper degree of sedation is known to increase the incidence of aspiration and other adverse events. So we planned to compare the depth of sedation between propofol and non-propofol based sedation in patients undergoing outpatient colonoscopy, as measured by an electroencephalogram (EEG) based monitor SEDLine monitor (SedlineInc., San Diego, CA). The non-randomized prospective observational study was performed in the outpatient gastroenterology suite of the Hospital of the University of Pennsylvania, Philadelphia. Patients included ASA class I-III aged more than 18 years scheduled for colonoscopy under Propofol or non-propofol based sedation. After an institutional review board approval, a written consent was obtained from prospective patients. Sedation (propofol or non-propofol based) was administered by either a certified nurse anesthetist under the supervision of an anesthesiologist (propofol) or a registered endoscopy nurse under the guidance of the endoscopist performing the procedure (non-propofol sedation). Depth of sedation was measured with an EEG based SEDLine monitor. The sedation providers were blinded to the patient state index-the indicator of depth of sedation. PSI (patient state index-SEDLine reading) was documented at colonoscope insertion, removal and at the return of verbal responsiveness after colonoscope withdrawal. Sedation spectrum was retrieved from the data stored on the SEDLine monitor. Patients sedated with propofol experience significantly deeper degrees of sedation at all times during the procedure. Additionally, during significant part of the procedure, they are at PSI levels associated with deep general anesthesia. The group that received propofol was more deeply sedated and had lower PSI values. Lighter propofol titration protocols may lead to improved patient care such as lowering risk of aspiration and hypotension. The role of processed EEG monitors such as the SEDLine monitor to improve sedation protocols remains to be determined. Trial registration We obtained an ethical clearance from the Institute. No trial registration was mandated, as no interventional drug or investigational device were used during the study.

DNA asymmetry in stem cells - immortal or mortal?

PubMed

Yadlapalli, Swathi; Yamashita, Yukiko M

2013-09-15

The immortal strand hypothesis proposes that stem cells retain a template copy of genomic DNA (i.e. an 'immortal strand') to avoid replication-induced mutations. An alternative hypothesis suggests that certain cells segregate sister chromatids non-randomly to transmit distinct epigenetic information. However, this area of research has been highly controversial, with conflicting data even from the same cell types. Moreover, historically, the same term of 'non-random sister chromatid segregation' or 'biased sister chromatid segregation' has been used to indicate distinct biological processes, generating a confusion in the biological significance and potential mechanism of each phenomenon. Here, we discuss the models of non-random sister chromatid segregation, and we explore the strengths and limitations of the various techniques and experimental model systems used to study this question. We also describe our recent study on Drosophila male germline stem cells, where sister chromatids of X and Y chromosomes are segregated non-randomly during cell division. We aim to integrate the existing evidence to speculate on the underlying mechanisms and biological relevance of this long-standing observation on non-random sister chromatid segregation.

The use of multimedia consent programs for surgical procedures: a systematic review.

PubMed

Nehme, Jean; El-Khani, Ussamah; Chow, Andre; Hakky, Sherif; Ahmed, Ahmed R; Purkayastha, Sanjay

2013-02-01

To compare multimedia and standard consent, in respect to patient comprehension, anxiety, and satisfaction, for various surgical/interventional procedures. Electronic searches of PubMed, MEDLINE, Ovid, Embase, and Google Scholar were performed. Relevant articles were assessed by 2 independent reviewers. Comparative (randomized and nonrandomized control trials) studies of multimedia and standard consent for a variety of surgical/interventional procedures were included. Studies had to report on at least one of the outcome measures. Studies were reviewed by 2 independent investigators. The first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. Overall, this review suggests that the use of multimedia as an adjunct to conventional consent appears to improve patient comprehension. Multimedia leads to high patient satisfaction in terms of feasibility, ease of use, and availability of information. There is no conclusive evidence demonstrating a significant reduction in preoperative anxiety.

Health disorders related to learning the welding trade: assessment of approaches to risk communication 1

PubMed Central

Bonow, Clarice Alves; Cezar-Vaz, Marta Regina; da Silva, Lauro Roberto Witt; Rocha, Laurelize Pereira; Turik, Claudia

2014-01-01

Objective to assess the identification of health disorders as self-reported by apprentices of welding and to analyze the strength of the relationship between age and time of experience with self-reported health disorders before and after a socio-environmental nursing intervention. Method this quasi-experimental, non-randomized, before-and-after study was conducted with 86 welding apprentices from a private entity. Results the results show a significant difference for the pre- and post-test means and an increase in the post-test mean score for the cardiovascular, respiratory and cutaneous systems. There was also a negative correlation between the apprentices' ages and the identification of health disorders. Conclusion the socio-environmental nursing intervention enabled obtaining information on health disorders related to welding. In turn, such information enabled the apprentices to assess information and self-report health disorders. PMID:24553702

Impact of a Fieldwork Experience on Attitudes Toward People With Intellectual Disabilities.

PubMed

Sullivan, Allison; Mendonca, Rochelle

The objective of this study was to describe the effects of curriculum activities on changing attitudes of health professional students toward people with intellectual disabilities (IDs). A nonrandomized, pretest-posttest design was used. Participants were college students assigned to one of three groups: two groups of students from different years in the occupational therapy program and one group of public health students. Each group completed the Attitudes Toward Intellectual Disabilities Questionnaire before and after each intervention. No significant differences were found in change of attitude after a lecture on the effects of stigma on people with disabilities. Length of time in program, age, and amount of experience with people with IDs affected changes in attitude for occupational therapy students after a fieldwork intervention. Level I fieldwork significantly improved the attitudes of occupational therapy students toward people with IDs, whereas a lecture did not. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Chemotherapy-Induced Nausea and Vomiting Mitigation With Music Interventions
.

PubMed

Kiernan, Jason M; Conradi Stark, Jody; Vallerand, April H

2018-01-01

Despite three decades of studies examining music interventions as a mitigant of chemotherapy-induced nausea and vomiting (CINV), to date, no systematic review of this literature exists.
. PubMed, Scopus, PsycInfo®, CINAHL®, Cochrane Library, and Google Scholar were searched. Keywords for all databases were music, chemotherapy, and nausea.
. All studies were appraised for methodology and results.
. 10 studies met inclusion criteria for review. Sample sizes were generally small and nonrandomized. Locus of control for music selection was more often with the investigator rather than the participant. Few studies controlled for the emetogenicity of the chemotherapy administered, nor for known patient-specific risk factors for CINV.
. The existing data have been largely generated by nurse scientists, and implications for nursing practice are many, because music interventions are low-cost, easily accessible, and without known adverse effects. However, this specific body of knowledge requires additional substantive inquiry to generate clinically relevant data.

Effects of Social Development Intervention in Childhood Fifteen Years Later

PubMed Central

Hawkins, J. David; Kosterman, Rick; Catalano, Richard F.; Hill, Karl G.; Abbott, Robert D.

2008-01-01

Objective To examine long-term effects of a universal intervention in elementary schools in promoting positive functioning in school, work, and community, and preventing mental health problems, risky sexual behavior, substance misuse, and crime at ages 24 and 27. Design Nonrandomized controlled trial followed participants to age 27, 15 years after the intervention ended. Three intervention conditions were compared: a full intervention group, assigned to intervention in grades 1 through 6; a late intervention group, assigned to intervention in grades 5 and 6 only; and a no-treatment control group. Setting Fifteen public elementary schools serving diverse neighborhoods including high-crime neighborhoods of Seattle. Participants A gender-balanced and multiethnic sample of 598 participants at ages 24 and 27 (93% of original sample in these conditions). Interventions Teacher training in classroom instruction and management, child social and emotional skill development, and parent workshops. Outcome Measures Self-reports of functioning in school, work and community, mental health, sexual behavior, substance use, and crime, and court records. Results A significant multivariate intervention effect across all 16 primary outcome indices was found. Specific effects included significantly better educational and economic attainment, mental health, and sexual health by age 27 (all p < .05). Hypothesized effects on substance use and crime were not found at ages 24 or 27. Conclusions A universal intervention for urban elementary school children, focused on classroom management and instruction, children’s social competence, and parenting practices, positively affected educational and economic attainment, mental health, and sexual health 15 years following the intervention’s end. PMID:19047540

Effectiveness of an educational intervention of physiotherapy in parents of children with haemophilia.

PubMed

Cuesta-Barriuso, R; Torres-Ortuño, A; López-García, M; Nieto-Munuera, J

2014-11-01

Haemophilia is a haematological disorder with an orthopaedic outcome. It requires not only medical but rather comprehensive care from infancy. The aim of this study was to assess the effectiveness of an educational intervention of Physiotherapy in parents of children with haemophilia under 4 years old. This is a non-randomized clinical trial, in which 22 parents participated children's with haemophilia under 4 years old. Half of them received an educational intervention of Physiotherapy. At the beginning and end of the study, a psychologist blinded to the assignment of subjects to each of the study groups, assessed the perceived quality of life, anxiety, perceived stress and family functioning of parents. A significant improvement was observed in the variables of perceived stress and family functioning of parents in the experimental group. The realization of an educational intervention in parents of children with haemophilia under 4 years old is effective. It reduces the stressors perceived by the parents and improves family cohesion and adaptability, as a consequence of the disease. It is necessary to carry out studies with follow-up periods to assess the effectiveness of educational programs of Physiotherapy for long term. © 2014 John Wiley & Sons Ltd.

Effects of Plantar Flexor Muscle Static Stretching Alone and Combined With Massage on Postural Balance.

PubMed

Hemmati, Ladan; Rojhani-Shirazi, Zahra; Ebrahimi, Samaneh

2016-10-01

To evaluate and compare the effects of stretching and combined therapy (stretching and massage) on postural balance in people aged 50 to 65 years. Twenty-three subjects participated in this nonrandomized clinical trial study. Each participant randomly received plantar flexor muscle stretching (3 cycles of 45 seconds with a 30-second recovery period between cycles) alone and in combination with deep stroking massage (an interval of at least 30 minutes separated the two interventions). The data were recorded with a force platform immediately after each condition with eyes open and closed. The center of pressure displacement and velocity along the mediolateral and anteroposterior axes were calculated under each condition. The data were analyzed with multiple-pair t-tests. The center of pressure displacement and velocity along the mediolateral axis increased after both stretching and the combined intervention. There were significant differences in both values between participants in the stretching and combined interventions (p<0.05). Plantar flexor muscle stretching (for 45 seconds) combined with deep stroking massage may have more detrimental effects on postural balance than stretching alone because each intervention can intensify the effects of the other.

Decision counseling and participation in a pancreas cancer registry.

PubMed

Myers, Ronald; Lavu, Harish; Keith, Scott W; Kelly, Heidi; O'Rourke, Nadine; Cocroft, James; Quinn, Anna; Potluri, Vishnu; Yeo, Charles J

2014-01-01

Cancer registries play a vital role in research, as they provide important data that can be used to assess disease etiology and risk. Specialty registries can help to address the need for information on defined cancer types. However, achieving high rates of participation in such registries is problematic.We studied the impact of decision support on patient participation in a hospital-based pancreas cancer registry, the Jefferson Pancreas Tumor Registry (JPTR). In this study, we assembled a nonrandomized cohort of 40 patients, of whom 20 were exposed to the intervention and 20 were exposed to routine recruiting methods. Patients in the control group were invited to join the JPTR; while those in the intervention group were also invited to join the JPTR, and received decision support related to participation. Registry participation was assessed at 90 days. At baseline, patient gender, race, and stage of pancreatic cancer did not vary significantly between study groups. Overall, participation in the intervention group was significantly higher (P = 0.01) than in the control group (55% and 10%, respectively). In the intervention group, altruism was the major factor motivating patient participation, while patient concerns related to treatment recovery, registration time and complexity, and the confidentiality of registry data discouraged participation.

Therapeutic Plasma Transfusion in Bleeding Patients: A Systematic Review.

PubMed

Levy, Jerrold H; Grottke, Oliver; Fries, Dietmar; Kozek-Langenecker, Sibylle

2017-04-01

Plasma products, including fresh frozen plasma, are administered extensively in a variety of settings from massive transfusion to vitamin K antagonist reversal. Despite the widespread use of plasma as a hemostatic agent in bleeding patients, its effect in comparison with other available choices of hemostatic therapies is unclear. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed Central, and databases of ongoing trials for randomized controlled trials that assessed the efficacy and/or safety of therapeutic plasma as an intervention to treat bleeding patients compared with other interventions or placebo. Of 1243 unique publications retrieved in our initial search, no randomized controlled trials were identified. Four nonrandomized studies described the effect of therapeutic plasma in bleeding patients; however, data gathered from these studies did not allow for comparison with other therapeutic interventions primarily as a result of the low number of patients and the use of different (or lack of) comparators. We identified two ongoing trials investigating the efficacy and safety of therapeutic plasma, respectively; however, no data have been released as yet. Although plasma is used extensively in the treatment of bleeding patients, evidence from randomized controlled trials comparing its effect with those of other therapeutic interventions is currently lacking.

A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer.

PubMed

Robb, Sheri L; Clair, Alicia A; Watanabe, Masayo; Monahan, Patrick O; Azzouz, Faouzi; Stouffer, Janice W; Ebberts, Allison; Darsie, Emily; Whitmer, Courtney; Walker, Joey; Nelson, Kirsten; Hanson-Abromeit, Deanna; Lane, Deforia; Hannan, Ann

2008-07-01

Coping theorists argue that environmental factors affect how children perceive and respond to stressful events such as cancer. However, few studies have investigated how particular interventions can change coping behaviors. The active music engagement (AME) intervention was designed to counter stressful qualities of the in-patient hospital environment by introducing three forms of environmental support. The purpose of this multi-site randomized controlled trial was to determine the efficacy of the AME intervention on three coping-related behaviors (i.e. positive facial affect, active engagement, and initiation). Eighty-three participants, ages 4-7, were randomly assigned to one of three conditions: AME (n = 27), music listening (ML; n = 28), or audio storybooks (ASB; n = 28). Conditions were videotaped to facilitate behavioral data collection using time-sampling procedures. After adjusting for baseline differences, repeated measure analyses indicated that AME participants had a significantly higher frequency of coping-related behaviors compared with ML or ASB. Positive facial affect and active engagement were significantly higher during AME compared with ML and ASB (p<0.0001). Initiation was significantly higher during AME than ASB (p<0.05). This study supports the use of the AME intervention to encourage coping-related behaviors in hospitalized children aged 4-7 receiving cancer treatment. (c) 2007 John Wiley & Sons, Ltd.

The Onset of STI Diagnosis through Age 30: Results from the Seattle Social Development Project Intervention

PubMed Central

Hill, Karl G.; Bailey, Jennifer A.; Hawkins, J. David; Catalano, Richard F.; Kosterman, Rick; Oesterle, Sabrina; Abbott, Robert D.

2013-01-01

Objectives To examine (1) whether onset of sexually transmitted infections (STI) through age 30 differed for youths who received a social developmental intervention during elementary grades compared to those in the control condition; (2) potential social-developmental mediators of this intervention; and (3) the extent to which these results differed by ethnicity. Design A nonrandomized controlled trial followed participants to age 30, 18 years after the intervention ended. Three intervention conditions were compared: a full intervention group, assigned to intervention in grades 1 through 6; a late intervention group, assigned to intervention in grades 5 and 6 only; and a no-treatment control group. Setting Eighteen public elementary schools serving diverse neighborhoods including high-crime neighborhoods of Seattle. Analysis Sample 608 participants in three intervention conditions interviewed from age 10 through 30. Interventions Teacher training in classroom instruction and management, child social and emotional skill development, and parent workshops. Outcome Cumulative onset of participant report of STI diagnosis. Intervention Mechanisms Adolescent family environment, bonding to school, antisocial peer affiliation, early sex initiation, alcohol use, cigarette use, and marijuana use were tested. Analysis and Results Complementary log-log survival analysis found significantly lower odds of STI onset for the full intervention compared to the control condition. The lowering of STI onset risk was significantly greater for African Americans and Asian Americans compared to European Americans. Family environment, school bonding and delayed initiation of sexual behavior mediated the relationship between treatment and STI hazard. Conclusions A universal intervention for urban elementary school children, focused on classroom management and instruction, children’s social competence, and parenting practices may reduce the onset of STI through age 30, especially for African Americans. PMID:23539433

The onset of STI diagnosis through age 30: results from the Seattle Social Development Project Intervention.

PubMed

Hill, Karl G; Bailey, Jennifer A; Hawkins, J David; Catalano, Richard F; Kosterman, Rick; Oesterle, Sabrina; Abbott, Robert D

2014-02-01

The objectives of this study were to examine (1) whether the onset of sexually transmitted infections (STI) through age 30 differed for youths who received a social developmental intervention during elementary grades compared to those in the control condition; (2) potential social-developmental mediators of this intervention; and (3) the extent to which these results differed by ethnicity. A nonrandomized controlled trial followed participants to age 30, 18 years after the intervention ended. Three intervention conditions were compared: a full-intervention group, assigned to intervention in grades 1 through 6; a late intervention group, assigned to intervention in grades 5 and 6 only; and a no-treatment control group. Eighteen public elementary schools serving diverse neighborhoods including high-crime neighborhoods of Seattle are the setting of the study. Six hundred eight participants in three intervention conditions were interviewed from age 10 through 30. Interventions include teacher training in classroom instruction and management, child social and emotional skill development, and parent workshops. Outcome is the cumulative onset of participant report of STI diagnosis. Adolescent family environment, bonding to school, antisocial peer affiliation, early sex initiation, alcohol use, cigarette use, and marijuana use were tested as potential intervention mechanisms. Complementary log-log survival analysis found significantly lower odds of STI onset for the full-intervention compared to the control condition. The lowering of STI onset risk was significantly greater for African Americans and Asian Americans compared to European Americans. Family environment, school bonding, and delayed initiation of sexual behavior mediated the relationship between treatment and STI hazard. A universal intervention for urban elementary school children, focused on classroom management and instruction, children's social competence, and parenting practices may reduce the onset of STI through age 30, especially for African Americans.

A protocol for a systematic review of the effectiveness of interventions to reduce exposure to lead through consumer products and drinking water

PubMed Central

2014-01-01

Background The toxic heavy metal lead continues to be a leading environmental risk factor, with the number of attributable deaths having doubled between 1990 and 2010. Although major sources of lead exposure, in particular lead in petrol, have been significantly reduced in recent decades, lead is still used in a wide range of processes and objects, with developing countries disproportionally affected. The objective of this systematic review is to assess the effectiveness of regulatory, environmental and educational interventions for reducing blood lead levels and associated health outcomes in children, pregnant women and the general population. Methods/design The databases MEDLINE, Embase and the Global Health Library (GHL) will be searched using a sensitive search strategy. Studies in English, German, French, Spanish, Italian or Afrikaans will be screened according to predefined inclusion and exclusion criteria. We will consider randomized and non-randomized studies accepted by the Cochrane Effective Practice and Organization of Care (EPOC) Group, as well as additional non-randomized studies. Screening of titles and abstracts will be performed by one author. Full texts of potentially relevant studies will be independently assessed for eligibility by two authors. A single author will extract data, with a second reviewer checking the extraction form. Risk of bias will be assessed by two researchers using the Graphical Appraisal Tool for Epidemiological studies, as modified by the Centre for Public Health at the UK National Institute for Health and Care Excellence. Any inconsistencies in the assessment of eligibility, data extraction or quality appraisal will be resolved through discussion. Where two or more studies report the primary outcome blood lead levels within the same population group, intervention category and source of lead exposure, data will be pooled using random effects meta-analysis. In parallel, harvest plots as a graphical method of evidence synthesis will be used to present findings for blood lead levels and secondary outcomes. Discussion This systematic review will fill an important evidence gap with respect to the effectiveness of interventions to reduce lead in consumer products and drinking water in the context of new WHO guidelines for the prevention and management of lead poisoning. It will also contribute to setting a future research agenda. PMID:24731516

Step It UP: a multicomponent intervention to increase stair use in a university residence building.

PubMed

Howie, Erin Kaye; Young, Deborah Rohm

2011-01-01

Examine the effects of a multicomponent intervention on stair usage. Nonrandomized controlled intervention. Two multistory university dormitories. Total of 5711 direct observations of university dormitory residents. The 2-week "Step It UP" intervention used poster prompts and fun/competitive challenges with incentives to encourage residents to take the stairs instead of the elevators. Ascending stair and elevator use was directly observed and coded for gender at high traffic times in intervention and control dormitories for 14 nonconsecutive hours over 1 week each at baseline, midintervention, and 1 week postintervention. The proportions of ascending stair and elevator users were compared using χ(2) analyses. Baseline stair use was equal between intervention and control dormitories (24.9% and 27.8%, respectively; χ(2)[1, N  =  1849]  =  .08; p  =  .77). Stair use significantly increased from baseline in the intervention dormitory to 33.24% (χ(2)[1, N  =  2192]  =  18.44; p < .001) compared with no change in the control. Stair use returned to baseline in the intervention dormitory at postintervention (25.4%; χ(2)[1, N  =  2297]  =  .08; p  =  .78). There were no significant differences between genders. This multicomponent, short-duration intervention significantly increased stair usage in a university dormitory relative to the control but was unable to sustain the increase when prompts were removed. Campaigns to sustain stair use are needed. Formative assessment is required to determine what combinations of components may yield the most cost-effective approach for future interventions.

Infant-mother attachment can be improved through group intervention: a preliminary evaluation in Spain in a non-randomized controlled trial.

PubMed

Torres, Bárbara; Alonso-Arbiol, Itziar; Cantero, María José; Abubakar, Amina

2011-11-01

The quality of infant-mother attachment has been linked to competence in different domains of child development. Research indicates that early intervention can enhance the quality of infant-mother attachment, though its efficacy in a group format has yet to be evaluated. The current study is aimed at examining the usefulness of a group intervention in enhancing infant-mother attachment. An intervention aimed at addressing aspects such as maternal responsivity, sensitivity and childrearing behaviour was developed by the researchers and experienced psychologists. The intervention spanned a period of 14 months starting from the third quarter of pregnancy. The intervention was evaluated among 24 mothers from the Basque region of Spain. The sample consisted of children of both genders in a similar proportion: 45.8% were boys and 54.2% were girls. The children in this sample were full-term born and did not present symptoms of any serious pre- or postnatal complications. The intervention had a statistically non-significant medium effect. Infants whose mothers had received the intervention showed higher rates of secure attachment compared to children from the control group, as assessed by the Strange Situation observation procedure. A potentially significant confounding variable, maternal attachment, was balanced across the intervention and comparison groups. We can tentatively point out that a group intervention may enhance the quality of infant-mother attachment. Nevertheless, because the study design was not randomized, the results of this study remain preliminary and need replication in a full randomized controlled trial designed study.

Development of a tobacco cessation intervention for Alaska Native youth

PubMed Central

Patten, Christi A.; Fadahunsi, Oluwole; Hanza, Marcelo; Smith, Christina M.; Hughes, Christine A.; Brockman, Tabetha A.; Boyer, Rahnia; Decker, Paul A.; Luger, Elizabeth; Sinicrope, Pamela S.; Offord, Kenneth P.

2013-01-01

Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and acceptability of a targeted cessation intervention developed for AN youth. Intervention components were informed by prior focus groups assessing treatment preferences among AN youth, a social cognitive theoretical framework and feedback obtained from a teen advisory group. The intervention consisted of a weekend program where youth traveled by small airplane from their villages to stay overnight with other adolescents who quit tobacco use together. The program included recreational activities, talking circles, personal stories from elders and teen advisors, and cognitive behavioral counseling. Two intervention pilots were conducted from October 2010 to January 2011 using a non-randomized, uncontrolled study design with assessments at baseline and six-week follow-up. One village in Western Alaska was selected for each pilot with a targeted enrollment of 10 adolescents each. Participants were recruited for each pilot within five days, but recruitment challenges and ‘‘lessons learned’’ are described. The first pilot enrolled nine adolescents (all female) aged 13–16 years; all nine attended the intervention program and 78% (7/9) completed follow-up. The second pilot enrolled 12 adolescents (eight females, four males) aged 12–17 years, of which seven attended the intervention program. Six of these seven participants (86%) completed follow-up. In both pilots, participants rated the intervention as highly acceptable. A targeted cessation intervention was feasible and acceptable to AN youth. The intervention will be tested for efficacy in a subsequent randomized controlled trial. PMID:24058327

Evaluation of a pre-existing, 3-year household water treatment and handwashing intervention in rural Guatemala

PubMed Central

Arnold, Benjamin; Arana, Byron; Mäusezahl, Daniel; Hubbard, Alan; Colford, John M

2009-01-01

Background The promotion of household water treatment and handwashing with soap has led to large reductions in child diarrhoea in randomized efficacy trials. Currently, we know little about the health effectiveness of behaviour-based water and hygiene interventions after the conclusion of intervention activities. Methods We present an extension of previously published design (propensity score matching) and analysis (targeted maximum likelihood estimation) methods to evaluate the behavioural and health impacts of a pre-existing but non-randomized intervention (a 3-year, combined household water treatment and handwashing campaign in rural Guatemala). Six months after the intervention, we conducted a cross-sectional cohort study in 30 villages (15 intervention and 15 control) that included 600 households, and 929 children <5 years of age. Results The study design created a sample of intervention and control villages that were comparable across more than 30 potentially confounding characteristics. The intervention led to modest gains in confirmed water treatment behaviour [risk difference = 0.05, 95% confidence interval (CI) 0.02–0.09]. We found, however, no difference between the intervention and control villages in self-reported handwashing behaviour, spot-check hygiene conditions, or the prevalence of child diarrhoea, clinical acute lower respiratory infections or child growth. Conclusions To our knowledge this is the first post-intervention follow-up study of a combined household water treatment and handwashing behaviour change intervention, and the first post-intervention follow-up of either intervention type to include child health measurement. The lack of child health impacts is consistent with unsustained behaviour adoption. Our findings highlight the difficulty of implementing behaviour-based household water treatment and handwashing outside of intensive efficacy trials. PMID:19574492

Attitudes of Registered and Licensed Practical Nurses About the Importance of Families in Surgical Hospital Units: Findings From the Landspitali University Hospital Family Nursing Implementation Project.

PubMed

Blöndal, Katrin; Zoëga, Sigridur; Hafsteinsdottir, Jorunn E; Olafsdottir, Olof Asdis; Thorvardardottir, Audur B; Hafsteinsdottir, Sigrun A; Sveinsdóttir, Herdis

2014-08-01

The purpose of this study was to examine attitudes of registered nurses and licensed practical nurses about the importance of the family in surgical hospital units before (T1) and after (T2) implementation of a Family Systems Nursing educational intervention based on the Calgary Family Assessment and Intervention Models. This study was part of the Landspitali University Hospital Family Nursing Implementation Project and used a nonrandomized, quasi-experimental design with nonequivalent group before and after and without a control group. There were 181 participants at T1 and 130 at T2. No difference was found in nurses' attitudes as measured by the Families Importance in Nursing Care-Nurses' Attitudes (FINC-NA) questionnaire, before and after the educational intervention. Attitudes toward families were favorable at both times. Analysis of demographic variables showed that age, work experience, and workplace (inpatient vs. outpatient units) had an effect on the nurses' attitudes toward families. The influence of work experience on attitudes toward family care warrants further exploration. © The Author(s) 2014.

Wacky Wednesday: use of distraction through humor to reduce preoperative anxiety in children and their parents.

PubMed

Berger, Jill; Wilson, Darlena; Potts, Linda; Polivka, Barbara

2014-08-01

The purpose of this study was to determine the effect of distraction through humor on anxiety among children having outpatient surgery, and their parents. Quasi-experimental design using a nonrandomized control group. The study assessed preoperative anxiety in child-parent dyads. The control group received usual care. The intervention group received the "Wacky Wednesday" (WW) intervention in which they entered an environment where employees were dressed in "wacky" attire and children and parents were provided with gifts and costume items. Anxiety scores, heart rate, and blood pressure were collected from patients and parents in both groups on admission and just before transfer to surgery. Children who arrived for surgery on WW had significantly lower anxiety scores on admission than children in the control group. In addition, children and parents who received the WW intervention had significantly lower anxiety scores just before surgery than those in the control group. Humor and distraction are effective with children and parents in relieving preoperative anxiety. Copyright © 2014 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Impact of cooking and home food preparation interventions among adults: outcomes and implications for future programs

PubMed Central

Reicks, Marla; Trofholz, Amanda C.; Stang, Jamie S; Laska, Melissa N.

2014-01-01

Objective Cooking programs are growing in popularity; however an extensive review has not examined overall impact. Therefore, this study reviewed previous research on cooking/home food preparation interventions and diet and health-related outcomes among adults and identified implications for practice and research. Design Literature review and descriptive summative method. Main outcome measures Dietary intake, knowledge/skills, cooking attitudes and self-efficacy/confidence, health outcomes. Analysis Articles evaluating effectiveness of interventions that included cooking/home food preparation as the primary aim (January 1980 through December 2011) were identified via OVID MEDLINE, Agricola and Web of Science databases. Studies grouped according to design and outcomes were reviewed for validity using an established coding system. Results were summarized for several outcome categories. Results Of 28 studies identified, 12 included a control group with six as non-randomized and six as randomized controlled trials. Evaluation was done post-intervention for five studies, pre- and post-intervention for 23 and beyond post-intervention for 15. Qualitative and quantitative measures suggested a positive influence on main outcomes. However, non-rigorous study designs, varying study populations, and use of non-validated assessment tools limited stronger conclusions. Conclusions and Implications Well-designed studies are needed that rigorously evaluate long-term impact on cooking behavior, dietary intake, obesity and other health outcomes. PMID:24703245

Bayesian methods including nonrandomized study data increased the efficiency of postlaunch RCTs.

PubMed

Schmidt, Amand F; Klugkist, Irene; Klungel, Olaf H; Nielen, Mirjam; de Boer, Anthonius; Hoes, Arno W; Groenwold, Rolf H H

2015-04-01

Findings from nonrandomized studies on safety or efficacy of treatment in patient subgroups may trigger postlaunch randomized clinical trials (RCTs). In the analysis of such RCTs, results from nonrandomized studies are typically ignored. This study explores the trade-off between bias and power of Bayesian RCT analysis incorporating information from nonrandomized studies. A simulation study was conducted to compare frequentist with Bayesian analyses using noninformative and informative priors in their ability to detect interaction effects. In simulated subgroups, the effect of a hypothetical treatment differed between subgroups (odds ratio 1.00 vs. 2.33). Simulations varied in sample size, proportions of the subgroups, and specification of the priors. As expected, the results for the informative Bayesian analyses were more biased than those from the noninformative Bayesian analysis or frequentist analysis. However, because of a reduction in posterior variance, informative Bayesian analyses were generally more powerful to detect an effect. In scenarios where the informative priors were in the opposite direction of the RCT data, type 1 error rates could be 100% and power 0%. Bayesian methods incorporating data from nonrandomized studies can meaningfully increase power of interaction tests in postlaunch RCTs. Copyright © 2015 Elsevier Inc. All rights reserved.

Stapedotomy in osteogenesis imperfecta: a prospective study of 32 consecutive cases.

PubMed

Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

2014-12-01

To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. A nonrandomized, open, prospective case series. A tertiary referral center. Twenty-five consecutive patients who underwent 32 primary stapedotomies for osteogenesis imperfecta with evidence of stapes fixation and available postoperative pure-tone audiometry. Primary stapedotomy with vein graft interposition and reconstruction with a regular Teflon piston or bucket handle-type piston. Preoperative and postoperative audiometric evaluation using conventional 4-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gap were measured. The overall audiometric results as well as the results of audiometric evaluation at 3 months and at least 1 year after surgery were used. Overall, postoperative air-bone gap closure to within 10 dB was achieved in 88% of cases. Mean (standard deviation) gain in air-conduction threshold was 22 (9.4) dB for the entire case series, and mean (standard deviation) air-bone gap closure was 22 (9.0) dB. Backward multivariate logistic regression showed that a model with preoperative air-bone gap closure and intraoperatively established incus length accurately predicts success after primary stapes surgery. Stapes surgery is a feasible and safe treatment option in patients with osteogenesis imperfecta. Success is associated with preoperative air-bone gap and intraoperatively established incus length.

Internal retinal layer thickness and macular migration after internal limiting membrane peeling in macular hole surgery.

PubMed

Faria, Mun Y; Ferreira, Nuno P; Mano, Sofia; Cristóvao, Diana M; Sousa, David C; Monteiro-Grillo, Manuel E

2018-05-01

To provide a spectral-domain optical coherence tomography (SD-OCT)-based analysis of retinal layers thickness and nasal displacement of closed macular hole after internal limiting membrane peeling in macular hole surgery. In this nonrandomized prospective interventional study, 36 eyes of 32 patients were subjected to pars plana vitrectomy and 3.5 mm diameter internal limiting membrane (ILM) peeling for idiopathic macular hole (IMH). Nasal and temporal internal retinal layer thickness were assessed with SD-OCT. Each scan included optic disc border so that distance between optic disc border and fovea were measured. Thirty-six eyes had a successful surgery with macular hole closure. Total nasal retinal thickening (p<0.001) and total temporal retinal thinning (p<0.0001) were observed. Outer retinal layers increased thickness after surgery (nasal p<0.05 and temporal p<0.01). Middle part of inner retinal layers (mIRL) had nasal thickening (p<0.001) and temporal thinning (p<0.05). The mIRL was obtained by deducting ganglion cell layer (GCL) and retinal nerve fiber layer (RNFL) thickness from overall thickness of the inner retinal layer. Papillofoveal distance was shorter after ILM peeling in macular hole surgery (3,651 ± 323 μm preoperatively and 3,361 ± 279 μm at 6 months; p<0.0001). Internal limiting membrane peel is associated with important alteration in inner retinal layer architecture, with thickening of mIRL and shortening of papillofoveal distance. These factors may contribute to recovery of disrupted foveal photoreceptor and vision improvement after IMH closure.

Effects of leptin deficiency and replacement on cerebellar response to food-related cues

PubMed Central

Berman, Steven M.; Paz-Filho, Gilberto; Wong, Ma-Li; Kohno, Milky; Licinio, Julio; London, Edythe D.

2013-01-01

Leptin affects eating behavior partly by altering the response of the brain to food-related stimuli. Effects of leptin on brain structure have been observed in the cerebellum, where leptin receptors are most densely expressed, but the function of leptin in the cerebellum remains unclear. We performed a nonrandomized, prospective interventional study of three adults with genetically-mediated leptin deficiency. FMRI was recorded three times each year during years 5 and 6 of leptin replacement treatment. Session one of each year occurred after 10 months of continuous daily replacement, session two after 33–37 days without leptin, and session three 14–23 days after daily replacement was restored. Statistical parametric mapping software (SPM5) was employed to contrast the fMRI blood-oxygenation level-dependent response to images of high-calorie foods versus images of brick walls. Covariate analyses quantified the effects of the duration of leptin replacement and concomitant changes in body mass on the cerebral responses. Longer duration of replacement was associated with more activation by food images in a ventral portion of the posterior lobe of the cerebellum, while simultaneous decreases in body mass were associated with decreased activation in a more dorsal portion of the same lobe. These findings indicate that leptin replacement reversibly alters neural function within the posterior cerebellum, and modulates plasticity-dependent brain physiology in response to food cues. The results suggest an underexplored role for the posterior cerebellum in the regulation of leptin-mediated processes related to food intake. PMID:22576622

Effect of intravitreal bevacizumab on diabetic macular edema with hard exudates

PubMed Central

Jeon, Sohee; Lee, Won Ki

2014-01-01

Background We evaluated the efficacy of intravitreal bevacizumab on diabetic macular edema with subfoveal and perifoveal hard exudates. Materials and methods Eleven eyes (11 patients) exhibiting diabetic macular edema with subfoveal and perifoveal hard exudates were included in this prospective, nonrandomized interventional pilot study. All patients were treated with monthly scheduled intravitreal bevacizumab injections for 6 months. Changes in the Early Treatment Diabetic Retinopathy Study best corrected visual acuity, amount of hard exudates on fundus photography, and macular edema detected by central subfield thickness on spectral domain optical coherence tomography after six serial injections, were assessed. The amount of hard exudates at each visit was evaluated as pixels in fundus photography, using an Adobe Photoshop program. Results Ten of 11 patients completed follow-up. The mean Early Treatment Diabetic Retinopathy Study best corrected visual acuity was 59.9±5.7 letters (Snellen equivalent, 20/63) at baseline evaluation. The best corrected visual acuity exhibited no significant difference at month 6 compared with at baseline (57.9±6.0 letters or 20/70 at month 6; P=0.085). At month 6, mean central subfield thickness decreased from 370.4±56.5 to 334.6±65.0 μm (P=0.009). The mean amount of hard exudates increased from 4467.1±2736.1 to 6592.4±2498.3 pixels at month 6 (P=0.022). No serious adverse events occurred. Conclusion Continuous intravitreal bevacizumab was found to have no benefit in visual acuity and amount of hard exudates, despite the improvement of macular edema at 6 months. PMID:25143708

Palliative sedation in end-of-life care and survival: a systematic review.

PubMed

Maltoni, Marco; Scarpi, Emanuela; Rosati, Marta; Derni, Stefania; Fabbri, Laura; Martini, Francesca; Amadori, Dino; Nanni, Oriana

2012-04-20

Palliative sedation is a clinical procedure aimed at relieving refractory symptoms in patients with advanced cancer. It has been suggested that sedative drugs may shorten life, but few studies exist comparing the survival of sedated and nonsedated patients. We present a systematic review of literature on the clinical practice of palliative sedation to assess the effect, if any, on survival. A systematic review of literature published between January 1980 and December 2010 was performed using MEDLINE and EMBASE databases. Search terms included palliative sedation, terminal sedation, refractory symptoms, cancer, neoplasm, palliative care, terminally ill, end-of-life care, and survival. A manual search of the bibliographies of electronically identified articles was also performed. Eleven published articles were identified describing 1,807 consecutive patients in 10 retrospective or prospective nonrandomized studies, 621 (34.4%) of whom were sedated. One case-control study was excluded from prevalence analysis. The most frequent reason for sedation was delirium in the terminal stages of illness (median, 57.1%; range, 13.8% to 91.3%). Benzodiazepines were the most common drug category prescribed. Comparing survival of sedated and nonsedated patients, the sedation approach was not shown to be associated with worse survival. Even if there is no direct evidence from randomized clinical trials, palliative sedation, when appropriately indicated and correctly used to relieve unbearable suffering, does not seem to have any detrimental effect on survival of patients with terminal cancer. In this setting, palliative sedation is a medical intervention that must be considered as part of a continuum of palliative care.

Oral Health–Related Quality of Life and Self-Rated Speech in Children With Existing Fistulas in Mid-Childhood and Adolescence

PubMed Central

Long, Ross E.; Wilson-Genderson, Maureen; Grayson, Barry H.; Flores, Roberto; Broder, Hillary L.

2016-01-01

Objective To report the associations of oro-nasal fistulae on the patient-centered outcomes oral health–related quality of life and self-reported speech outcomes in school aged-children. Design Prospective, nonrandomized multicenter design. Setting Six ACPA-accredited cleft centers. Participants Patients with cleft palate at the age of mixed dentition. Interventions None. Main Outcome Measures Prevalence of fistula and location of fistula (Pittsburgh Classification System). Patients were placed into one of three groups based on the following criteria: alveolar cleft present, no previous repair (Group 1); alveolar cleft present, previously repaired (Group 2); no congenital alveolar cleft (Group 3). Presence of fistula and subgroup classification were correlated to oral health–related quality of life (Child Oral Health Impact Profile [COHIP]) and perceived speech outcomes. Results The fistula rate was 5.52% (62 of 1198 patients). There was a significant difference in fistula rate between the three groups: Group 1 (11.15%), Group 2 (4.44%), Group 3 (1.90%). Patients with fistula had significantly lower COHIP scores (F1,1188 = 4.79; P = .03) and worse self-reported speech scores (F1,1197 = 4.27; P = .04). Group 1 patients with fistula had the lowest COHIP scores (F5,1188 = 4.78, P =.02) and the lowest speech scores (F5,1188 = 3.41, P = .003). Conclusions Presence of palatal fistulas was associated with lower oral health–related quality of life and perceived speech among youth with cleft. The poorest outcomes were reported among those with the highest fistula rates, including an unrepaired alveolar cleft. PMID:26437081

Prehospital cardiac arrest survival and neurologic recovery.

PubMed

Hillis, M; Sinclair, D; Butler, G; Cain, E

1993-01-01

Many studies of prehospital defibrillation have been conducted but the effects of airway intervention are unknown and neurologic follow-up has been incomplete. A non-randomized cohort prospective study was conducted to determine the effectiveness of defibrillation in prehospital cardiac arrest. Two ambulance companies in the study area developed a defibrillation protocol and they formed the experimental group. A subgroup of these patients received airway management with an esophageal obturator airway (EOA) or endotracheal intubation (ETT). The control group was composed of patients who suffered a prehospital cardiac arrest and did not receive prehospital defibrillation. All survivors were assessed for residual deficits using the Sickness Impact Profile (SIP) and the Dementia Rating Scale (DRS). A total of 221 patients were studied over a 32-month period. Both the experimental group (N = 161) and the control group (N = 60) were comparable with respect to age, sex distribution, and ambulance response time. Survival to hospital discharge was 2/60 (3.3%) in the control group and 12/161 (6.3%) in the experimental group. This difference is not statistically significant. Survival in the experimental group by airway management technique was basic airway support (3/76 3.9%), EOA (3/67 4.5%), and ETT (6/48 12.5%). The improved effect on survival by ETT management was statistically significant. Survivors had minor differences in memory, work, and recreation as compared to ischemic heart disease patients as measured by the SIP and DRS. No effect of defibrillation was found on survival to hospital discharge. However, endotracheal intubation improved survival in defibrillated patients. Survivors had a good functional outcome.

Nonrandom network connectivity comes in pairs.

PubMed

Hoffmann, Felix Z; Triesch, Jochen

2017-01-01

Overrepresentation of bidirectional connections in local cortical networks has been repeatedly reported and is a focus of the ongoing discussion of nonrandom connectivity. Here we show in a brief mathematical analysis that in a network in which connection probabilities are symmetric in pairs, P ij = P ji , the occurrences of bidirectional connections and nonrandom structures are inherently linked; an overabundance of reciprocally connected pairs emerges necessarily when some pairs of neurons are more likely to be connected than others. Our numerical results imply that such overrepresentation can also be sustained when connection probabilities are only approximately symmetric.

Mechanisms Leading to Nonrandom, Nonhomologous Chromosomal Translocations in Leukemia

PubMed Central

Gollin, Susanne M.

2007-01-01

Nonrandom, reciprocal translocations between nonhomologous chromosomes are critical cellular events that lead to malignant transformation. Therefore, understanding the mechanisms involved in these chromosomal rearrangements is essential for understanding the process of carcinogenesis. There has been substantial discussion in the literature over the past ten years about mechanisms involved in constitutional chromosomal rearrangements, including deletions, duplications, and translocations. Yet our understanding of the mechanisms of chromosomal rearrangements in cancer is still developing. This review presents what is known about the mechanisms involved in selected nonrandom chromosomal translocations in leukemia. PMID:17157028

Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial.

PubMed

Beauchet, Olivier; Barden, John; Liu-Ambrose, Teresa; Chester, Victoria L; Annweiler, Cedric; Szturm, Tony; Grenier, Sébastien; Léonard, Guillaume; Bherer, Louis; Allali, Gilles

2016-09-01

Few studies have examined the effect of anti-dementia drugs (i.e., acetylcholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists) on gait performance. Past studies have focused on the stride time (i.e., gait cycle duration) but not on the mental imagery of gait. To compare mental imagery of gait and spatiotemporal gait parameters in patients with dementia [i.e., Alzheimer's disease (AD) and non-AD] before and after the use of anti-dementia drugs (i.e., acetylcholinesterase inhibitors and memantine) and in controls (i.e., patients with dementia who did not take anti-dementia drugs). A total of 112 patients (mean age 82.5 ± 4.2 years, 68.8 % female) with mild-to-moderate AD and non-AD dementia were included in this non-randomized open-label trial (n = 56 in the Intervention group, and n = 56 in the Control group matched for age, sex, and stage and type of dementia) nested in a cohort study (mean follow-up 238.5 ± 79.8 days). Mental imagery of gait was assessed with the actual and imagined Timed Up and Go tests (aTUG and iTUG) and the difference between aTUG and iTUG (i.e., delta-TUG). Spatiotemporal gait parameters were measured with the GAITRite(®) system during normal walking. Participants in the Intervention group had a longer iTUG time (p < 0.001) and a lower delta-TUG value (p = 0.001) at the follow-up compared with those in the Control group. There was a significant increase in iTUG (p = 0.001) and decrease in delta-TUG (p < 0.001) from baseline to the follow-up only in the Intervention group. Multiple linear regression showed that the use of anti-dementia drugs was associated with a longer iTUG time and a lower delta-TUG value (best performance, p < 0.002). Our findings showed an improvement in mental imagery of gait with the use of anti-dementia drugs, but no changes in actual gait performance. NCT01315704.

Inverse probability weighting in STI/HIV prevention research: methods for evaluating social and community interventions

PubMed Central

Lippman, Sheri A.; Shade, Starley B.; Hubbard, Alan E.

2011-01-01

Background Intervention effects estimated from non-randomized intervention studies are plagued by biases, yet social or structural intervention studies are rarely randomized. There are underutilized statistical methods available to mitigate biases due to self-selection, missing data, and confounding in longitudinal, observational data permitting estimation of causal effects. We demonstrate the use of Inverse Probability Weighting (IPW) to evaluate the effect of participating in a combined clinical and social STI/HIV prevention intervention on reduction of incident chlamydia and gonorrhea infections among sex workers in Brazil. Methods We demonstrate the step-by-step use of IPW, including presentation of the theoretical background, data set up, model selection for weighting, application of weights, estimation of effects using varied modeling procedures, and discussion of assumptions for use of IPW. Results 420 sex workers contributed data on 840 incident chlamydia and gonorrhea infections. Participators were compared to non-participators following application of inverse probability weights to correct for differences in covariate patterns between exposed and unexposed participants and between those who remained in the intervention and those who were lost-to-follow-up. Estimators using four model selection procedures provided estimates of intervention effect between odds ratio (OR) .43 (95% CI:.22-.85) and .53 (95% CI:.26-1.1). Conclusions After correcting for selection bias, loss-to-follow-up, and confounding, our analysis suggests a protective effect of participating in the Encontros intervention. Evaluations of behavioral, social, and multi-level interventions to prevent STI can benefit by introduction of weighting methods such as IPW. PMID:20375927

Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

PubMed

Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

2016-04-01

The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

Internet-based intervention programme for obese adolescents and their families (Next.Step): research protocol of a controlled trial.

PubMed

Sousa, Pedro; Fonseca, Helena; Gaspar, Pedro; Gaspar, Filomena

2014-04-01

This paper describes the design and rationale of a controlled trial that aims to determine the effectiveness of an intervention programme in which the internet is used. Adolescent obesity is a major health problem, there being urgency to find effective interventions that induce behavioural change. The inclusion of the internet in the intervention may improve adolescents' adherence to the weight management programme and lead to adoption of healthier lifestyles. A clinical trial with a control group (non-randomized). Participants are adolescents with appointments at a paediatric obesity clinic (Portugal). Sample size was calculated according to the power analysis. The experimental group will follow the standard treatment protocol and receive free access to the e-therapeutic platform. The control group will follow the standard treatment protocol and join a waiting list. Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up for 12 weeks). This study was approved by the Ethical Committee for Health (Lisbon, Portugal) in January 2012 and funded by the Foundation for Science and Technology (Portugal) in December 2012. The results of this research will promote reflection on new approaches directed to treat adolescent obesity and on the promotion of healthy behaviours. We expect to gather empirical evidence of the intervention programme effectiveness. The expectations lie on the population health gains, empowerment in decision-making and adoption of healthier lifestyles. © 2013 John Wiley & Sons Ltd.

Intervention study on school meal habits in Norwegian 10-12-year-old children.

PubMed

IlløKken, Kristine E; Bere, Elling; Øverby, Nina C; Høiland, Renate; Petersson, Kirsten O; Vik, Frøydis N

2017-07-01

The aim of this study was to investigate whether a free school meal every day was associated with children's intake of healthy food during school. A non-randomized study design with an intervention and a control group was used to measure change in children's meal habits at lunchtime. In total, 164 children participated; 55 in the intervention group and 109 in the control group. Children in the intervention group were served a free, healthy school meal every school day. Participating children completed a questionnaire at baseline and at 6 months' follow up. Possible associations were evaluated with a healthy food score, which was calculated based on a food frequency questionnaire on lunch habits at school. Chi-square and Independent Samples t-test were used to analyse the data. At baseline, there was no significant difference in the healthy food score between the intervention and the control group ( p = 0.08). Children in the intervention group increased their healthy food score significantly compared with children in the control group after 6 months ( p ⩽ 0.01). Change in the healthy food score was mainly due to an increase in the intake of fruit ( p ⩽ 0.01), vegetables ( p ⩽ 0.01) and fish spread ( p = 0.02); all in favour of the intervention group. A serving of a free school meal every day for 6 months increased children's intake of healthy food at lunchtime compared with the control group. Further studies are needed to establish possible long-term effects.

Long-term follow-up of DDD and VDD pacing: a prospective non-randomized single-centre comparison of patients with symptomatic atrioventricular block.

PubMed

Marchandise, Sébastien; Scavée, Christophe; le Polain de Waroux, Jean-Benoit; de Meester, Christophe; Vanoverschelde, Jean-Louis; Debbas, Nadia

2012-04-01

This prospective non-randomized single-centre registry compared clinical outcome, pacing parameters, and long-term survival in patients receiving VDD or DDD pacemaker (PMs) for symptomatic atrioventricular (AV) block. Single-lead VDD (n= 166) and DDD (n= 254) PMs were implanted in 420 successive patients with isolated AV block between January 2001 and December 2009. At the end of the follow-up period [median 25 (1-141) months], there was no difference in the incidence of atrial fibrillation [11.2% in the VDD group; 11.4% in the DDD group (P= 0.95)], myocardial infarction [31.1% in the VDD group; 25.2% in the DDD group (P= 0.20)], or dilated cardiomyopathy [9.9% in the VDD group; 8.9% in the DDD group (P= 0.74)]. At last follow-up, 65.9% of the VDD PMs and 89.3% of the DDD PMs were still programmed in their original mode with good atrial sensing. Due to permanent atrial fibrillation, 7.9% patients out of the VDD group had been switched to VVIR mode and 8.7% patients out of the DDD group to VVIR or DDIR mode. The P-wave amplitude was poor (sensed P-wave <0.5 mV) in 19.1% of the VDD PM and 1.6% of the DDD PM (P< 0.001) and 7.1% of the VDD patients and 0.4% of the DDD patients had been switched to VVIR pacing mode due to P-wave undersensing and AV dissociation (P= 0.003). Symptomatic atrial undersensing requiring upgrading was similar in both groups. The overall survival, adjusted for age, was not significantly different in the VDD and the DDD group (log rank: 0.26). Moreover, Cox survival analysis excluded the pacing mode as a significant predictor of mortality [hazard ratio (HR) = 0.79, confidence interval (CI) (0.46-1.35), P= 0.39]. Comparing VDD and DDD pacing, a significantly larger number of VDD-paced patients developed poor atrial signal detection without clinical impact. However, atrial under sensing did not influence the incidence of atrial fibrillation, myocardial infarction, dilated cardiomyopathy, or mortality.

Higher 5-hydroxymethylcytosine identifies immortal DNA strand chromosomes in asymmetrically self-renewing distributed stem cells.

PubMed

Huh, Yang Hoon; Cohen, Justin; Sherley, James L

2013-10-15

Immortal strands are the targeted chromosomal DNA strands of nonrandom sister chromatid segregation, a mitotic chromosome segregation pattern unique to asymmetrically self-renewing distributed stem cells (DSCs). By nonrandom segregation, immortal DNA strands become the oldest DNA strands in asymmetrically self-renewing DSCs. Nonrandom segregation of immortal DNA strands may limit DSC mutagenesis, preserve DSC fate, and contribute to DSC aging. The mechanisms responsible for specification and maintenance of immortal DNA strands are unknown. To discover clues to these mechanisms, we investigated the 5-methylcytosine and 5-hydroxymethylcytosine (5hmC) content on chromosomes in mouse hair follicle DSCs during nonrandom segregation. Although 5-methylcytosine content did not differ significantly, the relative content of 5hmC was significantly higher in chromosomes containing immortal DNA strands than in opposed mitotic chromosomes containing younger mortal DNA strands. The difference in relative 5hmC content was caused by the loss of 5hmC from mortal chromosomes. These findings implicate higher 5hmC as a specific molecular determinant of immortal DNA strand chromosomes. Because 5hmC is an intermediate during DNA demethylation, we propose a ten-eleven translocase enzyme mechanism for both the specification and maintenance of nonrandomly segregated immortal DNA strands. The proposed mechanism reveals a means by which DSCs "know" the generational age of immortal DNA strands. The mechanism is supported by molecular expression data and accounts for the selection of newly replicated DNA strands when nonrandom segregation is initiated. These mechanistic insights also provide a possible basis for another characteristic property of immortal DNA strands, their guanine ribonucleotide dependency.

Preliminary healthy eating outcomes of SNaX, a pilot community-based intervention for adolescents.

PubMed

Bogart, Laura M; Elliott, Marc N; Uyeda, Kimberly; Hawes-Dawson, Jennifer; Klein, David J; Schuster, Mark A

2011-02-01

We used principles of community-based participatory research to develop and pilot test a 5-week intervention for middle school students, Students for Nutrition and eXercise (SNaX). SNaX aimed to translate school obesity-prevention policies into practice with peer advocacy of healthy eating and school cafeteria changes. A total 425 seventh graders (63% of all seventh graders) in the intervention school were surveyed at baseline regarding cafeteria attitudes and sugar-sweetened beverage consumption; of the 425 students, 399 (94%) were surveyed again at 1-month post-intervention. School cafeteria records were obtained from two schools: the intervention school and a nonrandomized selected comparison school with similar student socio-demographic characteristics. A total of 140 students in the intervention school were trained as peer advocates. In the intervention school, cafeteria attitudes among peer advocates significantly improved over time (approximately one-third of a standard deviation), whereas cafeteria attitudes of non-peer advocates remained stable; the improvement among peer advocates was significantly greater than the pre-post-change for non-peer advocates (b = .71, p < .001). Peer advocates significantly reduced their sugar-sweetened beverage intake (sports and fruit drinks), from 33% before intervention to 21% after intervention (p = .03). Cafeteria records indicated that servings of fruit and healthier entrées (salads, sandwiches, and yogurt parfaits) significantly decreased in the comparison school and significantly increased in the intervention school; the magnitude of changes differed significantly between the schools (p < .001). As compared with the non-peer advocates, peer advocates appeared to benefit more from the intervention. Future research should consider engaging parents, students, and other key community stakeholders to determine acceptable and sustainable cafeteria changes. Copyright © 2011 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Standalone Effects of a Cognitive Behavioral Intervention Using a Mobile Phone App on Psychological Distress and Alcohol Consumption Among Japanese Workers: Pilot Nonrandomized Controlled Trial.

PubMed

Hamamura, Toshitaka; Suganuma, Shinichiro; Ueda, Mami; Mearns, Jack; Shimoyama, Haruhiko

2018-03-22

Research that investigates standalone effects of a mobile phone-based cognitive behavioral therapy without any human contact for reducing both psychological distress and risky drinking has been advancing; however, the number of studies is still limited. A mobile phone app called Self Record that facilitates cognitive restructuring through self-monitoring of daily thoughts and activities was developed in Japan. This study conducted a nonrandomized controlled pilot trial of the Self Record app to investigate standalone effects of the intervention on psychological distress and alcohol consumption among Japanese workers. Additionally, we examined moderating effects of negative mood regulation expectancies, which are beliefs about one's ability to control one's negative mood. A quasi-experimental design with a 1-month follow-up was conducted online in Japan from February 2016 to March 2016. A research marketing company recruited participants. The selection criteria were being a Japanese full-time worker (age 20-59 years), experiencing mild to moderate psychological distress, and having some interest in self-record apps. Assignment to group was based on participants' willingness to use the app in the study. All participants completed outcome measures of negative mood regulation expectancies, positive well-being, general distress, depression, anxiety, and typical/most weekly alcohol consumption. From the recruitment, 15.65% (1083/6921) of participants met the inclusion criteria. Of these, 51.43% (557/1083) enrolled in the study: 54.9% (306/557) in the intervention group and 45.1% (251/557) in the control group. At the 1-month follow-up, 15.3% (85/557) of participants had dropped out. Intention-to-treat analyses revealed that participants in the intervention group reported increased typical drinking (η2=.009) and heavy drinking (η2=.001). Adherence to using the app was low; 64.8% (199/306) of participants in the intervention group discontinued using the app on the first day. Additionally, 65.7% (366/557) of the total sample did not correctly answer the validity checks in the outcome measures (eg, "Please select 'mildly agree' for this item"). Therefore, per-protocol analyses were conducted after removing these participants. Results showed that continuing app users (42/127) in the intervention group reported increases in anxiety (η2=.006), typical drinking (η2=.005), and heavy drinking (η2=.007) compared to those in the control group (85/127). Negative mood regulation expectancies moderated the effects of the intervention for general distress (beta=.39). Results were contrary to our hypotheses. Self-recording methods of standalone mobile phone interventions may heighten individuals' awareness of their pathological thought and drinking behavior, but may be insufficient to decrease them unless combined with a more intense or face-to-face intervention. Limitations include high attrition in this study; measures to improve the response rate are discussed. ©Toshitaka Hamamura, Shinichiro Suganuma, Mami Ueda, Jack Mearns, Haruhiko Shimoyama. Originally published in JMIR Mental Health (http://mental.jmir.org), 22.03.2018.

Duodenal Electric Stimulation: Results of a First-in-Man Study.

PubMed

Aberle, Jens; Busch, Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver

2016-02-01

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

PubMed

Albert, A; Altabre, C; Baró, F; Buendía, E; Cabero, A; Cancelo, M J; Castelo-Branco, C; Chantre, P; Duran, M; Haya, J; Imbert, P; Julía, D; Lanchares, J L; Llaneza, P; Manubens, M; Miñano, A; Quereda, F; Ribes, C; Vázquez, F

2002-03-01

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

The prospective impact of food pricing on improving dietary consumption: A systematic review and meta-analysis.

PubMed

Afshin, Ashkan; Peñalvo, José L; Del Gobbo, Liana; Silva, Jose; Michaelson, Melody; O'Flaherty, Martin; Capewell, Simon; Spiegelman, Donna; Danaei, Goodarz; Mozaffarian, Dariush

2017-01-01

While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. To quantify the prospective effect of changes in food prices on dietary consumption. We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price data were collected before 1990. Data were extracted independently and in duplicate. Findings were pooled using DerSimonian-Laird's random effects model. Pre-specified sources of heterogeneity were analyzed using meta-regression; and potential for publication bias, by funnel plots, Begg's and Egger's tests. From 3,163 identified abstracts, 23 interventional studies and 7 prospective cohorts with 37 intervention arms met inclusion criteria. In pooled analyses, a 10% decrease in price (i.e., subsidy) increased consumption of healthful foods by 12% (95%CI = 10-15%; N = 22 studies/intervention arms) whereas a 10% increase price (i.e. tax) decreased consumption of unhealthful foods by 6% (95%CI = 4-8%; N = 15). By food group, subsidies increased intake of fruits and vegetables by 14% (95%CI = 11-17%; N = 9); and other healthful foods, by 16% (95%CI = 10-23%; N = 10); without significant effects on more healthful beverages (-3%; 95%CI = -16-11%; N = 3). Each 10% price increase reduced sugar-sweetened beverage intake by 7% (95%CI = 3-10%; N = 5); fast foods, by 3% (95%CI = 1-5%; N = 3); and other unhealthful foods, by 9% (95%CI = 6-12%; N = 3). Changes in price of fruits and vegetables reduced body mass index (-0.04 kg/m2 per 10% price decrease, 95%CI = -0.08-0 kg/m2; N = 4); price changes for sugar-sweetened beverages or fast foods did not significantly alter body mass index, based on 4 studies. Meta-regression identified direction of price change (tax vs. subsidy), number of intervention components, intervention duration, and study quality score as significant sources of heterogeneity (P-heterogeneity<0.05 each). Evidence for publication bias was not observed. These prospective results, largely from interventional studies, support efficacy of subsidies to increase consumption of healthful foods; and taxation to reduce intake of unhealthful beverages and foods. Use of subsidies and combined multicomponent interventions appear most effective.

What are the health benefits of active travel? A systematic review of trials and cohort studies.

PubMed

Saunders, Lucinda E; Green, Judith M; Petticrew, Mark P; Steinbach, Rebecca; Roberts, Helen

2013-01-01

Increasing active travel (primarily walking and cycling) has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. The study design was a systematic review of (i) non-randomised and randomised controlled trials, and (ii) prospective observational studies examining either (a) the effects of interventions to promote active travel or (b) the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes.

What Are the Health Benefits of Active Travel? A Systematic Review of Trials and Cohort Studies

PubMed Central

Saunders, Lucinda E.; Green, Judith M.; Petticrew, Mark P.; Steinbach, Rebecca; Roberts, Helen

2013-01-01

Background Increasing active travel (primarily walking and cycling) has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. Methods The study design was a systematic review of (i) non-randomised and randomised controlled trials, and (ii) prospective observational studies examining either (a) the effects of interventions to promote active travel or (b) the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. Results Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. Conclusions Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes. PMID:23967064

The role of anaerobes in patients with ventilator-associated pneumonia and aspiration pneumonia: a prospective study.

PubMed

Marik, P E; Careau, P

1999-01-01

Aspiration of oropharyngeal material, with its high concentration of anaerobic bacteria, has been implicated in the pathogenesis of both ventilator-associated pneumonia (VAP) and aspiration pneumonitis (AP). Consequently, patients with these disorders are usually treated with antimicrobial agents with anaerobic activity. To determine the incidence of anaerobic bacteria in patients with VAP and AP. Prospective, nonrandomized, interventional study. University-affiliated community teaching hospital. We performed sequential blind protected specimen brush (PSB) sampling and mini-BAL in 143 patients with 185 episodes of suspected VAP and 25 patients with AP who required mechanical ventilation. Quantitative aerobic and anaerobic cultures were performed on all specimens. Pneumonia was considered to be present when either > 500 cfu/mL cultured from blind PSB sampling or > 5,000 cfu/mL cultured from mini-BAL were present. Using the predefined criteria, bacterial pneumonia was diagnosed in 63 of 185 suspected VAP episodes (34%) and 12 of 25 patients with AP (48%). At least one dose of an antibiotic was given in the 24 h prior to bacteriologic sampling in 106 suspected VAP episodes (57%) and in 12 patients with AP (48%). More than one pathogen was isolated from 11 VAP and four AP patients. Pseudomonas aeruginosa, Staphylococcus aureus, and enteric Gram-negative organisms were isolated most frequently from patients with VAP. In the patients with AP, enteric Gram-negative organisms were isolated in patients with GI disorders and Streptococcus pneumoniae and Haemophilus influenzae predominated in patients with "community-acquired" aspiration. Only one anaerobic organism was isolated from the entire group of patients; Veillonella paravula was isolated from a blind PSB specimen in a patient with suspected aspiration pneumonia. Despite painstaking effort, we were able to isolate only one anaerobic organism (nonpathogenic) from this group of patients. The spectrum of aerobes in patients with VAP was similar to that reported in the literature. The organisms found in patients with AP was a reflection of the organisms likely to colonize the oropharynx. The use of antibiotics with anaerobic coverage may not be necessary in patients with suspected VAP and AP. Furthermore, penicillin G and clindamycin may not be the antibiotics of choice in patients with AP.

Protocol of a prospective study for the combination treatment of Shu-Gan-jian-Pi decoction and steroid standard therapy in autoimmune hepatitis patients.

PubMed

Chi, Xiao-Ling; Xiao, Huan-Ming; Xie, Yu-Bao; Cai, Gao-Shu; Jiang, Jun-Min; Tian, Guang-Jun; Shi, Mei-Jie; Wu, Shu-Duo; Zhao, Peng-Tao; Chen, Hui-Jun

2016-12-07

Prednisone plus azathioprine is considered the mainstay of therapy in the current recommendations for autoimmune hepatitis (AIH). However, it does not provide good benefits for AIH patients because of its serious side effects. Therefore, more and more AIH patients prefer to seek for traditional Chinese medicine (TCM) to manage their symptoms and reduce the side effects of steroids in China. Shu-Gan-Jian-Pi Decoction is a popular used Chinese herbal formula in Guangdong province of China, which has demonstrated the effect of improving efficacy and reducing side effects of corticosteroids in AIH patients. The aim of this study is to evaluate the effects of Shu-Gan-Jian-Pi Decoction combined with steroid in AIH patients. So, this study aims to explore whether the combination treatment of Shu-Gan-Jian-Pi Decoction and steroid standard therapy could improve the clinical management of AIH. A prospective non-randomized study on AIH will be conducted between October 2015 and June 2017 in Guangdong Provincial hospital of Chinese medicine. Eligible AIH patients will be classified as the case group (n = 66) and the control group (n = 66) based on the interventions. Patients taking Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine will be in the case group and those taking prednisone and azathioprine will be in the control group. The whole study will last 48 weeks, including a 24-week observation period and a 24-week follow-up period. The primary outcome was complete response to therapy, defined as complete biochemical remission at the patient's last visit of observation period and the absence of predefined steroid-specific side effects throughout treatment. This trial will evaluate the efficacy and safety of Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine on AIH patients. The achievement of this trial will provide evidence-based data for Shu-Gan-Jian-Pi Decoction, which could provide good benefits for AIH patients. Chinese Clinical Trial Registry: ChiCTR-OOC-15006155 . Registration date: 28 March 2015.

Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study.

PubMed

Gray, William A; Rosenfield, Kenneth A; Jaff, Michael R; Chaturvedi, Seemant; Peng, Lei; Verta, Patrick

2011-02-01

The aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS). The CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS. In this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009. The rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties. Outcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination. (Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"; NCT00302237). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Diabetes Prevention Program Community Outreach Perspectives on Lifestyle Training and Translation

PubMed Central

Venditti, Elizabeth M.; Kramer, M. Kaye

2013-01-01

The gap between what is known from clinical efficacy research and the systematic community translation of diabetes prevention programs is narrowing. During the past 5 years, numerous randomized and nonrandomized dissemination studies have evaluated the modified delivery of structured Diabetes Prevention Program (DPP) interventions in diverse real-world settings. Programs of sufficient dose and duration, implemented with fidelity, have reported weight losses in the range of 4%–7% with associated improvements in cardiometabolic risk factors at 6 and 12 months from baseline. The current article describes some of the experiences and perspectives of a team of University of Pittsburgh researchers as they have engaged in these efforts. PMID:23498296

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults.

PubMed

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. THE AIMS OF THIS SYSTEMATIC REVIEW ARE: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed.

The development of a systemic school-based intervention: Marte Meo and coordination meetings.

PubMed

Axberg, Ulf; Hansson, Kjell; Broberg, Anders G; Wirtberg, Ingegerd

2006-09-01

Antisocial behavior is often persistent, and in addition to causing suffering to children and their families, it also poses considerable costs for society. Children who display externalizing behavior in their early years run a high risk of having severe problems later in life. There is a need for treatment methods that may be used in various settings because these children constitute a group that is hard to reach with conventional treatment methods. In addition, the dropout rate from ordinary treatment is often high. In the present study, a systemic school-based model for early detection and intervention among 4-12-year-old children who displayed externalizing behavior problems was developed and examined in a nonrandomized study in the county of Skaraborg in Sweden. The intervention was collaborative and included a combination of the Marte Meo model and coordination meetings based on systemic theory and practice. Treatment effects in the group who had received the intervention were compared with a group who had received treatment as usual in their ordinary school setting. Assessments were carried out before, and 2 years after, the intervention. For the intervention group (N = 33), there was a significant decrease in the children's reported symptoms in school and in the home. No decrease in externalizing behavior was found in the comparison group (N = 16). There were no dropouts in the intervention group after the intervention had begun. The results are promising; the study demonstrates that it is possible to work effectively with many children who display externalizing behavior problems in a nonclinical setting.

An Intervention Study Examining the Effects of Condom Wrapper Graphics and Scent on Condom Use in the Botswana Defence Force

PubMed Central

Tran, Bonnie Robin; Thomas, Anne Goldzier; Vaida, Florin; Ditsela, Mooketsi; Phetogo, Robert; Kelapile, David; Haubrich, Richard; Chambers, Christina; Shaffer, Richard

2014-01-01

Free condoms provided by the government are often not used by Botswana Defence Force (BDF) personnel due to a perceived unpleasant scent and unattractive wrapper. Formative work with the BDF found that scented condoms and military inspired (camouflage) wrapper graphics were appealing to personnel. A non-randomized intervention study was implemented to determine if condom wrapper graphics and scent improved condom use in the BDF. Four military sites were selected for participation. Two sites in the south received the intervention condom wrapped in a generic wrapper and two sites in the north received the intervention condom wrapped in a military inspired wrapper; intervention condoms were either scented or unscented. 211 male soldiers who ever had sex, aged 18–30 years, and stationed at one of the selected sites consented to participate. Sexual activity and condom use were measured pre- and post-intervention using sexual behavior diaries. A condom use rate (CUR; frequency of protected sex divided by total frequency of sex) was computed for each participant. Mean CURs significantly increased over time (85.7% baseline vs. 94.5% post-intervention). Adjusted odds of condom use over time were higher among participants who received the intervention condom packaged in the military wrapper compared with the generic wrapper. Adjusted odds of condom use were also higher for participants who reported using scented versus unscented condoms. Providing scented condoms and condoms packaged in a miltiary inspired wrapper may help increase condom use and reduce HIV infection among military personnel. PMID:24266459

A primary health-care intervention on pre- and postnatal risk factor behavior to prevent childhood allergy. The Prevention of Allergy among Children in Trondheim (PACT) study.

PubMed

Storrø, Ola; Oien, Torbjørn; Dotterud, Christian K; Jenssen, Jon A; Johnsen, Roar

2010-07-28

This study aimed to evaluate the impact of a primary prevention intervention program on risk behavior for allergic diseases among children up to 2 years of age. The setting was in ordinary pre- and postnatal primary health care in Trondheim, Norway. The Prevention of Allergy among Children in Trondheim, Norway (PACT) study invited all pregnant women and parents to children up to 2 years of age in the community to participate in a non-randomized, controlled, multiple life-style intervention study. Interventional topics was increased dietary intake of cod liver oil and oily fish for women during pregnancy and for infants during the first 2 years of life, reduced parental smoking and reduced indoor dampness. A control cohort was established prior to the intervention cohort with "follow up as usual". Questionnaires were completed in pregnancy, 6 weeks after birth and at 1 and 2 years of age. Trends in exposure and behavior are described. Intake of oily fish and cod liver oil increased statistically significantly among women and infants in the intervention cohort compared to the control cohort. There was a low postnatal smoking prevalence in both cohorts, with a trend towards a decreasing smoking prevalence in the control cohort. There was no change in indoor dampness or in behavior related to non- intervened life-style factors. The dietary intervention seemed to be successful. The observed reduced smoking behavior could not be attributed to the intervention program, and the latter had no effect on indoor dampness. (Current Controlled Trials registration number: ISRCTN28090297).

Limited effectiveness of HIV prevention for young people in sub-Saharan Africa: studying the role of intervention and evaluation

PubMed Central

Michielsen, K.

2013-01-01

On average, 2,500 young people (15-24 years) get infected with HIV every day; 80% of which live in sub-Saharan Africa. Since no cure or vaccine is available, reducing sexual risk behaviour in this group is crucial in tackling the epidemic. The general objective of this doctoral study was to improve the effectiveness of HIV prevention interventions for young people in sub-Saharan Africa. First, we assessed the overall effectiveness of such interventions (systematic literature review, meta-analysis). Secondly, we evaluated a school-based peer-led HIV prevention interventions in Rwanda (longitudinal, non-randomized controlled trial), to get insight into how interventions are developed, implemented and evaluated. While the first two objectives demonstrated limited effectiveness, the third objective aimed to identify reasons for this limited effectiveness: a) baseline characteristics of respondents that predict participation were identified (using data from objective 2); b) we studied determinants of young people’s sexual behavior using a qualitative ‘mailbox study’ that assessed the spontaneous thoughts of Rwandan adolescents on sexuality; c) we assessed the role of one specific structural factor: education (literature review and analysis of existing datasets); d) we assessed the theoretical underpinnings of existing HIV prevention interventions for young people in sub-Saharan Africa (literature review). Based on these studies, we discuss two main reasons for the observed limited effectiveness: factors associated with the intervention (strong focus on cognitions and moral, and implementation issues), and with evaluation (design, power, indicators). Recommendations for improving interventions, evaluations and for further research are provided. PMID:24753945

Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs.

PubMed

Wyman, Peter A; Henry, David; Knoblauch, Shannon; Brown, C Hendricks

2015-10-01

The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for non-random selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in two Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed.

Designs for testing group-based interventions with limited numbers of social units: The dynamic wait-listed and regression point displacement designs

PubMed Central

Wyman, Peter A.; Brown, C. Hendricks

2015-01-01

The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for nonrandom selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in 2 Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed. PMID:25481512

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

Inpatient Addiction Consultation for Hospitalized Patients Increases Post-Discharge Abstinence and Reduces Addiction Severity.

PubMed

Wakeman, Sarah E; Metlay, Joshua P; Chang, Yuchiao; Herman, Grace E; Rigotti, Nancy A

2017-08-01

Alcohol and drug use results in substantial morbidity, mortality, and cost. Individuals with alcohol and drug use disorders are overrepresented in general medical settings. Hospital-based interventions offer an opportunity to engage with a vulnerable population that may not otherwise seek treatment. To determine whether inpatient addiction consultation improves substance use outcomes 1 month after discharge. Prospective quasi-experimental evaluation comparing 30-day post-discharge outcomes between participants who were and were not seen by an addiction consult team during hospitalization at an urban academic hospital. Three hundred ninety-nine hospitalized adults who screened as high risk for having an alcohol or drug use disorder or who were clinically identified by the primary nurse as having a substance use disorder. Addiction consultation from a multidisciplinary specialty team offering pharmacotherapy initiation, motivational counseling, treatment planning, and direct linkage to ongoing addiction treatment. Addiction Severity Index (ASI) composite score for alcohol and drug use and self-reported abstinence at 30 days post-discharge. Secondary outcomes included 90-day substance use measures and self-reported hospital and ED utilization. Among 265 participants with 30-day follow-up, a greater reduction in the ASI composite score for drug or alcohol use was seen in the intervention group than in the control group (mean ASI-alcohol decreased by 0.24 vs. 0.08, p < 0.001; mean ASI-drug decreased by 0.05 vs. 0.02, p = 0.003.) There was also a greater increase in the number of days of abstinence in the intervention group versus the control group (+12.7 days vs. +5.6, p < 0.001). The differences in ASI-alcohol, ASI-drug, and days abstinent all remained statistically significant after controlling for age, gender, employment status, smoking status, and baseline addiction severity (p = 0.018, 0.018, and 0.02, respectively). In a sensitivity analysis, assuming that patients who were lost to follow-up had no change from baseline severity, the differences remained statistically significant. In a non-randomized cohort of medical inpatients, addiction consultation reduced addiction severity for alcohol and drug use and increased the number of days of abstinence in the first month after hospital discharge.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515) and the intervention group received lecture plus a simulation exercise (n l+s=1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Surgical and nonsurgical interventions for vulvar and clitoral pain in girls and women living with female genital mutilation: A systematic review.

PubMed

Ezebialu, Ifeanyichukwu; Okafo, Obiamaka; Oringanje, Chukwudi; Ogbonna, Udoezuo; Udoh, Ekong; Odey, Friday; Meremikwu, Martin M

2017-02-01

Vulvar and clitoral pain are known complications of female genital mutilation (FGM). Several interventions have been used to treat these conditions. This review focuses on surgical and nonsurgical interventions to improve vulvar and clitoral pain in women living with FGM. To evaluate the impact of nonsurgical and surgical interventions for alleviating vulvar and clitoral pain in women living with any type of FGM and to assess the associated adverse events. The search included the following major databases: Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, Scopus, Web of Science, and ClinicalTrials.gov. These were searched from inception until August 10, 2015 without any language restrictions. Study designs included randomized controlled trials, cluster randomized trials, nonrandomized trials, cohort studies, case-control studies, controlled before-and-after studies, historical control studies, and interrupted time series with reported data comparing outcomes among women with FGM who were treated for clitoral or vulvar pain with either surgical or nonsurgical interventions. Two team members independently screened studies for eligibility. No studies were included. Limited information exists on management of vulvar and clitoral pain in women living with FGM. This constitutes an important area for further research. CRD42015024521. © 2017 International Federation of Gynecology and Obstetrics.The World Health Organization retains copyright and all other rights in the manuscript of this article as submitted for publication.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

Background The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l =515) and the intervention group received lecture plus a simulation exercise (n l+s =1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Discussion Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study.

PubMed

Levac, Danielle; McCormick, Anna; Levin, Mindy F; Brien, Marie; Mills, Richard; Miller, Elka; Sveistrup, Heidi

2018-02-01

To compare changes in gross motor skills and functional mobility between ambulatory children with cerebral palsy who underwent a 1-week clinic-based virtual reality intervention (VR) followed by a 6-week, therapist-monitored home active video gaming (AVG) program and children who completed only the 6-week home AVG program. Pilot non-randomized controlled trial. Five children received 1 hour of VR training for 5 days followed by a 6-week home AVG program, supervised online by a physical therapist. Six children completed only the 6-week home AVG program. The Gross Motor Function Measure Challenge Module (GMFM-CM) and Six Minute Walk Test (6MWT) evaluated change. There were no significant differences between groups. The home AVG-only group demonstrated a statistically and clinically significant improvement in GMFM-CM scores following the 6-week AVG intervention (median difference 4.5 points, interquartile range [IQR] 4.75, p = 0.042). The VR + AVG group demonstrated a statistically and clinically significant decrease in 6MWT distance following the intervention (median decrease 68.2 m, IQR 39.7 m, p = 0.043). All 6MWT scores returned to baseline at 2 months post-intervention. Neither intervention improved outcomes in this small sample. Online mechanisms to support therapist-child communication for exercise progression were insufficient to individualize exercise challenge.

The impact of patient and physician computer mediated communication skill training on reported communication and patient satisfaction.

PubMed

Roter, Debra L; Wexler, Randy; Naragon, Phyllis; Forrest, Brian; Dees, Jason; Almodovar, Astrid; Wood, Julie

2012-09-01

The objective was to evaluate parallel patient and physician computer-mediated communication skill training on participants' report of skill use and patient satisfaction. Separate patient and clinician web-tools comprised of over 500, 10-s video clips demonstrating patient-centered skills in various ways. Four clinician members of the American Academy of Family Physicians National Research Network participated by enrolling 194 patients into a randomized patient trial and 29 physicians into a non-randomized clinician trial of respective interventions. All participants completed baseline and follow-up self-report measures of visit communication and satisfaction. Intervention patients reported using more skills than controls in five of six skill areas, including identification of problems/concerns, information exchange, treatment adherence, shared decision-making and interpersonal rapport (all p<.05); post intervention, physicians reported using more skills in the same 5 areas (all p<.01). Intervention group patients reported higher levels of satisfaction than controls in five of six domains (all p<.05). Communication skill training delivered in a computer mediated format had a positive and parallel impact on both patient and clinician reported use of patient-centered communication and in patient satisfaction. Computer-mediated interventions are cost and time effective thereby increasing patient and clinician willingness to undertake training. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Nutrition education intervention for women with breast cancer: effect on nutritional factors and oxidative stress.

PubMed

Schiavon, Cecilia C; Vieira, Francilene G K; Ceccatto, Vanessa; de Liz, Sheyla; Cardoso, Alyne L; Sabel, Cristiane; Gonzalez-Chica, David A; da Silva, Edson L; Galvan, Daisy; Crippa, Carlos G; Di Pietro, Patricia F

2015-01-01

To assess the effect of a nutrition education intervention on nutritional factors and oxidative stress during treatment of breast cancer. Nonrandomized clinical trial conducted in 2010-2011, including an evaluation at baseline and after 12 months. Women from Brazil who had breast cancer, divided into an intervention group (IG) (n = 18) and comparison group (n = 75). To increase intake of fruits and vegetables and reduce red and processed meats, via telephone and printed materials. Food intake, anthropometry, and levels of lipid hydroperoxide, carbonyl proteins, reduced glutathione, and ferric reducing antioxidant power. Chi-square, Mann-Whitney or t tests for baseline data; Wilcoxon or paired t tests for intra-group outcomes, linear regression models, and Bonferroni multiplicity adjustment. The researchers observed an increase in fruit and vegetable intake, reduction in red and processed meat intake, no change in body weight, and an increase in glutathione in the IG over the comparison group. However, after Bonferroni adjustment, only the consumption of fruits and vegetables and fruit was significantly higher in IG. This study presents improved dietary changes after a theory-driven nutrition education intervention. Although the sample size is small, it has proven to be clinically relevant. Copyright © 2015 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A two-year follow-up on a program theory of return to work intervention.

PubMed

Jensen, Anne Grete Claudi

2013-01-01

Validation of a salutogenic theory for return to work (RTW) and an associated program process theory. A longitudinal non-randomized one-year trial study design was used with a two-year follow-up and with comparison to a reference group. Changes in attitudes and active behaviour in the intervention group and at the workplace were supported by cognitive and behavioural approaches. The intervention group included 118 unskilled Danish public employees and privately employed house-cleaners on sick leave due to musculoskeletal and/or common mental illnesses. Significant improvements of work ability index and perceived health (SF36 subgroups) were reported. A significantly higher RTW and a shorter sick leave than in the reference group also emerged. Positive predictors of RTW were keeping the pre-sick-leave job and improving work ability index and physical impairment/role physical. Decline in self-efficacy was a negative predictor. Support for the theory and associated program process theory was found. The intervention seemed to influence RTW and the employees' attitudes, behaviour and health by affecting comprehensibility, meaningfulness and manageability. Sustainable RTW emerged from a synergism of support from the work place and improved personal resources, especially such as concern mental health. The approach is consistent with integrating health promotion in RTW.

Effectiveness of interventions targeting health behaviors in university and college staff: a systematic review.

PubMed

Plotnikoff, Ronald; Collins, Clare E; Williams, Rebecca; Germov, John; Callister, Robin

2015-01-01

Evaluate the literature on interventions targeting tertiary education staff within colleges and universities for improvements in health behaviors such as physical activity, dietary intake, and weight loss. One online database, Medline, was searched for literature published between January 1970 and February 2013. All quantitative study designs, including but not limited to randomized controlled trials, quasi-experimental studies, nonrandomized experimental trials, cohort studies, and case-control studies, were eligible. Data extraction was performed by one reviewer using a standardized form developed by the researchers. Extraction was checked for accuracy and consistency by a second reviewer. Data in relation to the above objective were extracted and described in a narrative synthesis. Seventeen studies were identified that focused on staff within the tertiary education setting. The review yielded overall positive results with 13 reporting significant health-related improvements. Weight loss, physical activity and fitness, and/or nutrition were the focus in more than half (n = 9) of the studies. This appears to be the first review to examine health interventions for tertiary education staff. There is scope to enhance cross-disciplinary collaboration in the development and implementation of a "Healthy University" settings-based approach to health promotion in tertiary education workplaces. Universities or colleges could serve as a research platform to evaluate such intervention strategies.

Higher 5-hydroxymethylcytosine identifies immortal DNA strand chromosomes in asymmetrically self-renewing distributed stem cells

PubMed Central

Huh, Yang Hoon; Cohen, Justin; Sherley, James L.

2013-01-01

Immortal strands are the targeted chromosomal DNA strands of nonrandom sister chromatid segregation, a mitotic chromosome segregation pattern unique to asymmetrically self-renewing distributed stem cells (DSCs). By nonrandom segregation, immortal DNA strands become the oldest DNA strands in asymmetrically self-renewing DSCs. Nonrandom segregation of immortal DNA strands may limit DSC mutagenesis, preserve DSC fate, and contribute to DSC aging. The mechanisms responsible for specification and maintenance of immortal DNA strands are unknown. To discover clues to these mechanisms, we investigated the 5-methylcytosine and 5-hydroxymethylcytosine (5hmC) content on chromosomes in mouse hair follicle DSCs during nonrandom segregation. Although 5-methylcytosine content did not differ significantly, the relative content of 5hmC was significantly higher in chromosomes containing immortal DNA strands than in opposed mitotic chromosomes containing younger mortal DNA strands. The difference in relative 5hmC content was caused by the loss of 5hmC from mortal chromosomes. These findings implicate higher 5hmC as a specific molecular determinant of immortal DNA strand chromosomes. Because 5hmC is an intermediate during DNA demethylation, we propose a ten-eleven translocase enzyme mechanism for both the specification and maintenance of nonrandomly segregated immortal DNA strands. The proposed mechanism reveals a means by which DSCs “know” the generational age of immortal DNA strands. The mechanism is supported by molecular expression data and accounts for the selection of newly replicated DNA strands when nonrandom segregation is initiated. These mechanistic insights also provide a possible basis for another characteristic property of immortal DNA strands, their guanine ribonucleotide dependency. PMID:24082118

Mental health impact of social capital interventions: a systematic review.

PubMed

Flores, Elaine C; Fuhr, Daniela C; Bayer, Angela M; Lescano, Andres G; Thorogood, Nicki; Simms, Victoria

2018-02-01

Mental disorders are a major contributor to the global burden of disease and disability, and can be extremely costly at both individual and community level. Social capital, (SC) defined as an individual's social relationships and participation in community networks, may lower the risk of mental disorders while increasing resilience capacity, adaptation and recovery. SC interventions may be a cost-effective way of preventing and ameliorating these conditions. However, the impact of these SC interventions on mental health still needs research. We conducted a systematic review of SC-based interventions to investigate their effect on mental health outcomes from controlled, quasi-experimental studies or pilot trials. We searched twelve academic databases, three clinical trials registries, hand-searched references and contacted field experts. Studies' quality was assessed with the Cochrane Risk of Bias tools for randomized and non-randomized studies. Seven studies were included in the review, published between 2006 and 2016. There was substantial heterogeneity in the definitions of both SC and mental disorders among the studies, preventing us from calculating pooled effect sizes. The interventions included community engagement and educative programs, cognitive processing therapy and sociotherapy for trauma survivors, and neighbourhood projects. There are paucity of SC interventions investigating the effect on mental health outcomes. This study showed that both SC scores and mental health outcomes improved over time but there was little evidence of benefit compared to control groups in the long term. Further high-quality trials are needed, especially among adverse populations to assess sustainability of effect.

The effect of a short anti-smoking awareness programme on the knowledge, attitude and practice of cigarette smoking among secondary school students in Lagos state, Nigeria.

PubMed

Odukoya, O O; Odeyemi, K A; Oyeyemi, A S; Upadhyay, R P

2014-06-01

This study aimed to assess the effect of a short school-based anti-smoking program on the knowledge, attitude and practice of cigarette smoking among students in secondary schools in Lagos State. A non-randomized, controlled intervention study was done among respondents selected using multi-stage sampling. Baseline data was collected using self-administered questionnaires. An anti-smoking awareness programme was carried out among students in the intervention group using health talks, information leaflets and posters. Post-intervention data collection took place three months later. There were significant increments in the mean knowledge and attitude scores after the intervention. There was however no statistically significant change in the current smoking habits of respondents (4% vs. 3%; p=0.41)in the intervention group. Nevertheless, in the intervention group, the number of never- smokers who reported that they were likely to initiate cigarette smoking within the next year significantly reduced. There was also a significant increase in the proportion of current smokers who desired to quit smoking. Even brief anti-smoking programs of this nature are effective at improving the knowledge and modifying the attitude of the respondents but do not improve smoking habits. It however motivated the desire to quit among current smokers. Health education sessions and periodic anti-smoking programmes should be introduced into the secondary school curriculum. More intensive approaches may be needed to influence the smoking behaviour of adolescent smokers.

Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review.

PubMed

Lin, Kuan-Yin; Granger, Catherine L; Denehy, Linda; Frawley, Helena C

2015-11-01

To identify, evaluate and synthesize the evidence examining the effectiveness of pelvic floor muscle training (PFMT) on bowel dysfunction in patients who have undergone colorectal cancer surgery. Eight electronic databases (MEDLINE 1950-2014; CINAHL 1982-2014; EMBASE 1980-2014; Scopus 1823-2014; PsycINFO 1806-2014; Web of Science 1970-2014; Cochrane Library 2014; PEDro 1999-2014) were systematically searched in March 2014. Reference lists of identified articles were cross referenced and hand searched. Randomized controlled trials, cohort studies and case series were included if they investigated the effects of conservative treatments, including PFMT on bowel function in patients with colorectal cancer following surgery. Two reviewers independently assessed the risk of bias of studies using the Newcastle-Ottawa Scale (NOS). Six prospective non-randomized studies and two retrospective studies were included. The mean (SD) NOS risk of bias score was 4.9 (1.2) out of 9; studies were limited by a lack of non-exposed cohort, lack of independent blinded assessment, heterogeneous treatment protocols, and lack of long-term follow-up. The majority of studies reported significant improvements in stool frequency, incontinence episodes, severity of fecal incontinence, and health-related quality of life (HRQoL) after PFMT. Meta-analysis was not possible due to lack of randomized controlled trials. Pelvic floor muscle training for patients following surgery for colorectal cancer appears to be associated with improvements in bowel function and HRQoL. Results from non-randomized studies are promising but randomized controlled trials with sufficient power are needed to confirm the effectiveness of PFMT in this population. © 2014 Wiley Periodicals, Inc.

Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review.

PubMed

Rossini, Gabriele; Parrini, Simone; Castroflorio, Tommaso; Deregibus, Andrea; Debernardi, Cesare L

2015-09-01

To assess the scientific evidence related to the efficacy of clear aligner treatment (CAT) in controlling orthodontic tooth movement. PubMed, PMC, NLM, Embase, Cochrane Central Register of Controlled Clinical Trials, Web of Knowledge, Scopus, Google Scholar, and LILACs were searched from January 2000 to June 2014 to identify all peer-reviewed articles potentially relevant to the review. Methodological shortcomings were highlighted and the quality of the studies was ranked using the Cochrane Tool for Risk of Bias Assessment. Eleven relevant articles were selected (two Randomized Clinical Trials (RCT), five prospective non-randomized, four retrospective non-randomized), and the risk of bias was moderate for six studies and unclear for the others. The amount of mean intrusion reported was 0.72 mm. Extrusion was the most difficult movement to control (30% of accuracy), followed by rotation. Upper molar distalization revealed the highest predictability (88%) when a bodily movement of at least 1.5 mm was prescribed. A decrease of the Little's Index (mandibular arch: 5 mm; maxillary arch: 4 mm) was observed in aligning arches. CAT aligns and levels the arches; it is effective in controlling anterior intrusion but not anterior extrusion; it is effective in controlling posterior buccolingual inclination but not anterior buccolingual inclination; it is effective in controlling upper molar bodily movements of about 1.5 mm; and it is not effective in controlling rotation of rounded teeth in particular. However, the results of this review should be interpreted with caution because of the number, quality, and heterogeneity of the studies.

GreenLight laser vs diode laser vaporization of the prostate: 3-year results of a prospective nonrandomized study.

PubMed

Guo, Sanwei; Müller, Georg; Bonkat, Gernot; Püschel, Heike; Gasser, Thomas; Bachmann, Alexander; Rieken, Malte

2015-04-01

Laser vaporization of the prostate is one of the alternatives to transurethral resection of the prostate. Short-term studies report a comparable outcome after laser vaporization with the 532 nm 120-W GreenLight high-performance system (HPS) laser and the 980 nm 200 W high-intensity diode (diode) laser. In this study, we analyzed the intermediate-term results of both techniques. From January 2007 to January 2008, 112 consecutive patients with symptomatic benign prostate enlargement were nonrandomly assigned to treatment with the GreenLight laser or the diode laser. Perioperative parameters, postoperative functional outcome, complications, and the reoperation rate at 3 years were analyzed. Improvement of voiding symptoms (International Prostate Symptom Score, quality-of-life) and micturition parameters (maximum flow rate, postvoid residual volume) showed no significant difference between the HPS group and the diode group. A significantly higher reoperation rate was observed in the diode group in comparison to the HPS group (37.5% vs 8.9%, p=0.0003) due to obstructive necrotic tissue (16.1% vs 0%, p=0.0018), bladder neck stricture (16.1% vs 1.8%, p=0.008), and persisting or recurrent adenoma (5.4% vs 7.1%, p=0.70), respectively. Both lasers lead to comparable improvement of voiding parameters and micturition symptoms. Treatment with the 200 W diode laser led to a significantly higher reoperation rate, which might be attributed to a higher degree of coagulation necrosis. Thus, a careful clinical application of this diode laser type is warranted.

The management of multidrug-resistant Enterobacteriaceae.

PubMed

Bassetti, Matteo; Peghin, Maddalena; Pecori, Davide

2016-12-01

Multidrug-resistant (MDR) Enterobacteriaceae are often related to the production of extended-spectrum b-lactamases (ESBLs) and carbapenemase-producing Enterobacteriaceae (CRE), and represent an increasing global threat. Recommendations for the therapeutic management of MDR-related infections, however, are mainly derived from retrospective and nonrandomized prospective studies. The aim of this review is to discuss the challenges in the treatment of patients with infections because of MDR Enterobacteriaceae and provide an expert opinion while awaiting for more definitive data. To avoid the selection of carbapenemase-producing Enterobacteriaceae, carbapenem-sparing strategies should be considered. B-lactams/b-lactamase inhibitors, mainly piperacillin-tazobactam, minimum inhibitory concentration (MIC) 16/4mg/ml or less represents the best alternative to carbapenems for the treatment of ESBL-producing strains. Overall, combination therapy may be preferred over monotherapy for CRE. The combination of a carbapenem-containing regimen with colistin or high-dose tigecycline or aminoglycoside can be administered at high-dose prolonged infusion with therapeutic drug monitoring for the treatment of CRE with MIC for meropenem 8-16 mg/l or less. For MIC higher than 8-16 mg/l, the use of meropenem should be avoided and various combination therapies based on the in-vitro susceptibility of antimicrobials (e.g., colistin, high-dose tigecycline, fosfomycin, and aminoglycosides) should be selected. Carbapenem-sparing strategies should be used, when feasible, for ESBL infections. The majority of available nonrandomized studies highlight that combination for CRE seem to offer some therapeutic advantage over monotherapy. Strict infection control measures toward MDR Gram-negative pathogens remain necessary while awaiting for new treatment options.

Non-random loss of chromosome 3 during transition of Helicobacter pylori-associated gastric MALT to B-cell MALT lymphoma revealed by fluorescence in situ hybridization.

PubMed

Banerjee, S K; Weston, A P; Persons, D L; Campbell, D R

1997-12-16

Acquired gastric mucosa-associated lymphoid tissue (MALT) accumulates as a result of long-standing Helicobacter pylori (H. pylori) infection and from this acquired MALT, low-grade B-cell MALT lymphoma may develop. Carcinogenesis is a multistep, multifactorial process involving the progressive accumulation of genetic changes. To determine whether numerical chromosomal alterations are involved in the transition of H. pylori-associated human gastric MALT to low-grade B-cell MALT lymphoma, frozen biopsy specimens prospectively obtained from H. pylori positive gastric MALT and gastric MALT lymphoma patients, as well as normal control patients (normal gastroscopy/gastric mucosal histology/H. pylori negative), were analyzed by fluorescence in situ hybridization (FISH). Fluorescent, directly labeled alpha-satellite DNA probes, specific for the centromeres of chromosomes 1, 3, 4, 11, 17 and Y were used in this study. The non-random loss of chromosome 3 was detected in two MALT patients and in all five MALT lymphoma patients. Trisomy 17 was detected in one MALT patient and one MALT lymphoma patient. Trisomy 1 was detected in a single MALT lymphoma patient as was trisomy 3. None of the MALT patients had trisomy 3 or trisomy 1. Monosomy 17 was noted in one MALT lymphoma patient. Clonal aneusomy was not observed in any patient for chromosomes Y, 4 or 11. These results suggest that the consistent loss of chromosome 3 may be an important genetic alteration in the transformation of H. pylori-associated gastric MALT into low-grade B-cell gastric MALT lymphoma.

Systematic review of hip fracture rehabilitation practices in the elderly.

PubMed

Chudyk, Anna M; Jutai, Jeffrey W; Petrella, Robert J; Speechley, Mark

2009-02-01

To address the need for a research synthesis on the effectiveness of the full range of hip fracture rehabilitation interventions for older adults and make evidence based conclusions. Medline, PubMed, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials were searched from 1980 to 2007 for studies published in English. The terms rehabilitation and hip fracture were exploded in order to obtain related search terms and categories. In the initial search of the databases, a combined total of 1031 articles was identified. Studies that did not focus on hip fracture rehabilitation, did not include persons over the age of 50 years, and/or did not include measures of physical outcome were excluded. Only studies with an Oxford Center for Evidence-Based Medicine Levels of Evidence level of I (randomized controlled trial, RCT) or II (cohort) were reviewed. The methodologic quality of both types of studies was assessed using a modified version of the Downs and Black checklist. There were 55 studies that met our selection criteria: 30 RCTs and 25 nonrandomized trials. They were distributed across 6 categories for rehabilitation intervention (care pathways, early rehabilitation, interdisciplinary care, occupational and physical therapy, exercise, intervention not specified) and 3 settings (acute care hospital, postacute care/rehabilitation, postrehabilitation). When looking across all of the intervention types, the most frequently reported positive outcomes were associated with measures of ambulatory ability. Eleven intervention categories across 3 settings were associated with improved ambulatory outcomes. Seven intervention approaches were related to improved functional recovery, while 6 intervention approaches were related to improved strength and balance recovery. Decreased length of stay and increased falls self-efficacy were associated with 2 interventions, while 1 intervention had a positive effect on lower-extremity power generation.

A Systematic Review of Palliative Care Intervention Outcomes and Outcome Measures in Low-Resource Countries.

PubMed

Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna

2018-05-01

To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

A Community-Based Positive Deviance/Hearth Infant and Young Child Nutrition Intervention in Ecuador Improved Diet and Reduced Underweight.

PubMed

Roche, Marion L; Marquis, Grace S; Gyorkos, Theresa W; Blouin, Brittany; Sarsoza, Julieta; Kuhnlein, Harriet V

2017-03-01

Underweight and stunting are serious problems in Ecuador that require interventions in the first 2 years of life. The researchers assessed the effectiveness of a Positive Deviance (PD)/Hearth community-based intervention using local foods to improve infant and young children's nutrition. A quasi-experimental nonrandomized study was conducted between March and October, 2009. The intervention and study were implemented in the Ecuadorian highlands provinces of Chimborazo and Tungurahua. Eighty mother-child pairs in 6 intervention communities and 184 mother-child pairs in 9 comparison communities. Mothers met in participatory peer-led PD/Hearth cooking and nutrition education sessions for 12 days. Dietary intake and nutritional status were collected at baseline and 6-month follow-up. Multiple linear and logistic regression were used for growth outcomes, and ANCOVA for mean dietary intakes. Mothers in the intervention were 1.3-5.7 times more likely to feed their children the promoted foods (P < .05). Children in the intervention consumed a higher percentage of recommended intakes for iron, zinc, vitamin A, protein, and energy (P < .05) at follow-up and had improvements in weight-for-age z-score (β = .17; 95% confidence interval, 0.01-0.31). Likelihood of underweight was reduced for children in the intervention (odds ratio = 0.36; 95% confidence interval, 0.13-0.96) CONCLUSIONS AND IMPLICATIONS: The PD/Hearth interventions support mothers to improve infant and young children's nutrition practices and reduce underweight. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Improvement of Early Antenatal Care Initiation: The Effects of Training Local Health Volunteers in the Community.

PubMed

Liabsuetrakul, Tippawan; Oumudee, Nurlisa; Armeeroh, Masuenah; Nima, Niamina; Duerahing, Nurosanah

2018-01-01

Although antenatal care (ANC) coverage has been increasing in low- and middle-income countries, the adherence to the ANC initiation standards at gestational age <12 weeks was inadequate including Thailand. The study aimed to improve the rate of early ANC initiation by training the existing local health volunteers (LHVs) in 3 southernmost provinces of Thailand. A clustered nonrandomized intervention study was conducted from November 2012 to February 2014. One district of each province was selected to be the study intervention districts for that province. A total of 124 LHVs in the intervention districts participated in the knowledge-counseling intervention. It was organized as half-day workshop using 2 training modules each comprising a 30-minute lecture followed by counseling practice in pairs for 1 hour. Outcome was the rate of early ANC initiation among women giving birth, and its association with intervention, meeting an LHV, and months after training was analyzed. Of 6677 women, 3178 and 3499 women were in the control and intervention groups, respectively. Rates of early ANC were significantly improved after the intervention (adjusted odds ratio [OR]: 1.29, 95% confidence interval [CI]: 1.17-1.43, P < .001) and meeting an LHV (adjusted OR: 2.06, 95% CI: 1.86-2.29, P < .001), but lower at 6 months after training (adjusted OR: 0.76, 95% CI: 0.60-0.96, P = .002). Almost all women (99.7%) in the intervention group who met an LHV reported that they were encouraged to attend early ANC. Training LHVs in communities by knowledge-counseling intervention significantly improved early ANC initiation, but the magnitude of change was still limited.

Effect of transfer, lifting, and repositioning (TLR) injury prevention program on musculoskeletal injury among direct care workers.

PubMed

Black, Timothy R; Shah, Syed M; Busch, Angela J; Metcalfe, Judy; Lim, Hyun J

2011-04-01

Musculoskeletal injuries among health care workers is very high, particularly so in direct care workers involved in patient handling. Efforts to reduce injuries have shown mixed results, and strong evidence for intervention effectiveness is lacking. The purpose of our study was to evaluate the effectiveness of a Transfer, Lifting and Repositioning (TLR) program to reduce musculoskeletal injuries (MSI) among direct health care workers. This study was a pre- and post-intervention design, utilizing a nonrandomized control group. Data were collected from the intervention group (3 hospitals; 411 injury cases) and the control group (3 hospitals; 355 injury cases) for periods 1 year pre- and post-intervention. Poisson regression analyses were performed. Of a total 766 TLR injury cases, the majority of injured workers were nurses, mainly with back, neck, and shoulder body parts injured. Analysis of all injuries and time-loss rates (number of injuries/100 full-time employees), rate ratios, and rate differences showed significant differences between the intervention and control groups. All-injuries rates for the intervention group dropped from 14.7 pre-intervention to 8.1 post-intervention. The control group dropped from 9.3 to 8.4. Time-loss injury rates decreased from 5.3 to 2.5 in the intervention group and increased in the control group (5.9 to 6.5). Controlling for group and hospital size, the relative rate of all-injuries and time-loss injuries for the pre- to post-period decreased by 30% (RR = 0.693; 95% CI = 0.60-0.80) and 18.6% (RR = 0.814; 95% CI = 0.677-0.955), respectively. The study provides evidence for the effectiveness of a multifactor TLR program for direct care health workers, especially in small hospitals.

Improvement of Early Antenatal Care Initiation

PubMed Central

Oumudee, Nurlisa; Armeeroh, Masuenah; Nima, Niamina; Duerahing, Nurosanah

2018-01-01

Background: Although antenatal care (ANC) coverage has been increasing in low- and middle-income countries, the adherence to the ANC initiation standards at gestational age <12 weeks was inadequate including Thailand. The study aimed to improve the rate of early ANC initiation by training the existing local health volunteers (LHVs) in 3 southernmost provinces of Thailand. Methods: A clustered nonrandomized intervention study was conducted from November 2012 to February 2014. One district of each province was selected to be the study intervention districts for that province. A total of 124 LHVs in the intervention districts participated in the knowledge–counseling intervention. It was organized as half-day workshop using 2 training modules each comprising a 30-minute lecture followed by counseling practice in pairs for 1 hour. Outcome was the rate of early ANC initiation among women giving birth, and its association with intervention, meeting an LHV, and months after training was analyzed. Results: Of 6677 women, 3178 and 3499 women were in the control and intervention groups, respectively. Rates of early ANC were significantly improved after the intervention (adjusted odds ratio [OR]: 1.29, 95% confidence interval [CI]: 1.17-1.43, P < .001) and meeting an LHV (adjusted OR: 2.06, 95% CI: 1.86-2.29, P < .001), but lower at 6 months after training (adjusted OR: 0.76, 95% CI: 0.60-0.96, P = .002). Almost all women (99.7%) in the intervention group who met an LHV reported that they were encouraged to attend early ANC. Conclusion: Training LHVs in communities by knowledge–counseling intervention significantly improved early ANC initiation, but the magnitude of change was still limited. PMID:29657959

Feasibility and impact study of a reward-based mobile application to improve adolescents' snacking habits.

PubMed

De Cock, Nathalie; Van Lippevelde, Wendy; Vangeel, Jolien; Notebaert, Melissa; Beullens, Kathleen; Eggermont, Steven; Deforche, Benedicte; Maes, Lea; Goossens, Lien; Verbeken, Sandra; Moens, Ellen; Vervoort, Leentje; Braet, Caroline; Huybregts, Lieven; Kolsteren, Patrick; Van Camp, John; Lachat, Carl

2018-04-02

Adolescents' snacking habits are driven by both explicit reflective and implicit hedonic processes. Hedonic pathways and differences in sensitivity to food rewards in addition to reflective determinants should be considered. The present study evaluated the feasibility and impact of a mobile phone-delivered intervention, incorporating explicit reflective and implicit rewarding strategies, on adolescents' snack intake. Adolescents (n 988; mean age 14·9 (sd 0·70) years, 59·4 % boys) completed a non-randomized clustered controlled trial. Adolescents (n 416) in the intervention schools (n 3) were provided with the intervention application for four weeks, while adolescents (n 572) in the control schools (n 3) followed the regular curriculum. Outcomes were differences in healthy snacking ratio and key determinants (awareness, intention, attitude, self-efficacy, habits and knowledge). Process evaluation data were collected via questionnaires and through log data of the app. No significant positive intervention effects on the healthy snack ratio (b=-3·52 (se 1·82), P>0·05) or targeted determinants were observed. Only 268 adolescents started using the app, of whom only fifty-five (20·5 %) still logged in after four weeks. Within the group of users, higher exposure to the app was not significantly associated with positive intervention effects. App satisfaction ratings were low in both high and low user groups. Moderation analyses revealed small positive intervention effects on the healthy snack ratio in high compared with low reward-sensitive boys (b=1·38 (se 0·59), P<0·05). The intervention was not able to improve adolescents' snack choices, due to low reach and exposure. Future interventions should consider multicomponent interventions, teacher engagement, exhaustive participatory app content development and tailoring.

Assessment of the effectiveness of physical activity interventions in the Brazilian Unified Health System

PubMed Central

Ribeiro, Evelyn Helena Corgosinho; Garcia, Leandro Martin Totaro; Salvador, Emanuel Péricles; Costa, Evelyn Fabiana; Andrade, Douglas Roque; Latorre, Maria do Rosario Dias de Oliveira; Florindo, Alex Antonio

2017-01-01

ABSTRACT OBJECTIVE To assess the effect of interventions on the levels of physical activity of healthy adults, users of the Brazilian Unified Health System and attended by the Family Health Strategy. METHODS Non-randomized experimental study with 157 adults allocated in three groups: 1) physical exercise classes (n = 54), 2) health education (n = 54), 3) control (n = 49). The study lasted for18 months, with 12 months of interventions and six months of follow-up after intervention. Assessments took place at the beginning, in the 12 months, and in the 18 months of study. Physical activity has been assessed by questionnaires and accelerometry. For the analyses, we have used the intention-to-treat principle and generalized estimating equations. RESULTS After 12 months, both intervention groups have increased the minutes of weekly leisure time physical activity and annual scores of physical exercise, leisure and transport-related physical activity. The exercise class group has obtained the highest average annual physical exercises score when compared to the other groups (p < 0.001). In the follow-up period, the exercise class group reduced its annual score (average: -0.3; 95%CI -0.5–-0.1), while the health education group increased this score (average: 0.2; 95%CI 0.1–0.4). There have been no differences in the levels of physical activity measured by accelerometry. CONCLUSIONS The interventions have been effective in increasing the practice of physical activity. However, we have observed that the health education intervention was more effective for maintaining the practice of physical activity in the period after intervention. We recommend the use of both interventions to promote physical activity in the Brazilian Unified Health System, according to the local reality of professionals, facilities, and team objectives. PMID:28678906

The Nonrandom Distribution of Interior Landforms for 100-km Diameter Craters on Mercury Suggests Regional Variations in Near-Surface Mechanical Properties

NASA Astrophysics Data System (ADS)

Herrick, R. R.

2018-05-01

There is great diversity of appearance in the interiors of 100-km diameter craters. The spatial distribution of interior landforms is clustered and nonrandom, but does not clearly correlate with Mercury's surface geology patterns.

Weight distributions for turbo codes using random and nonrandom permutations

NASA Technical Reports Server (NTRS)

Dolinar, S.; Divsalar, D.

1995-01-01

This article takes a preliminary look at the weight distributions achievable for turbo codes using random, nonrandom, and semirandom permutations. Due to the recursiveness of the encoders, it is important to distinguish between self-terminating and non-self-terminating input sequences. The non-self-terminating sequences have little effect on decoder performance, because they accumulate high encoded weight until they are artificially terminated at the end of the block. From probabilistic arguments based on selecting the permutations randomly, it is concluded that the self-terminating weight-2 data sequences are the most important consideration in the design of constituent codes; higher-weight self-terminating sequences have successively decreasing importance. Also, increasing the number of codes and, correspondingly, the number of permutations makes it more and more likely that the bad input sequences will be broken up by one or more of the permuters. It is possible to design nonrandom permutations that ensure that the minimum distance due to weight-2 input sequences grows roughly as the square root of (2N), where N is the block length. However, these nonrandom permutations amplify the bad effects of higher-weight inputs, and as a result they are inferior in performance to randomly selected permutations. But there are 'semirandom' permutations that perform nearly as well as the designed nonrandom permutations with respect to weight-2 input sequences and are not as susceptible to being foiled by higher-weight inputs.

No evidence for MHC class II-based non-random mating at the gametic haplotype in Atlantic salmon.

PubMed

Promerová, M; Alavioon, G; Tusso, S; Burri, R; Immler, S

2017-06-01

Genes of the major histocompatibility complex (MHC) are a likely target of mate choice because of their role in inbreeding avoidance and potential benefits for offspring immunocompetence. Evidence for female choice for complementary MHC alleles among competing males exists both for the pre- and the postmating stages. However, it remains unclear whether the latter may involve non-random fusion of gametes depending on gametic haplotypes resulting in transmission ratio distortion or non-random sequence divergence among fused gametes. We tested whether non-random gametic fusion of MHC-II haplotypes occurs in Atlantic salmon Salmo salar. We performed in vitro fertilizations that excluded interindividual sperm competition using a split family design with large clutch sample sizes to test for a possible role of the gametic haplotype in mate choice. We sequenced two MHC-II loci in 50 embryos per clutch to assess allelic frequencies and sequence divergence. We found no evidence for transmission ratio distortion at two linked MHC-II loci, nor for non-random gamete fusion with respect to MHC-II alleles. Our findings suggest that the gametic MHC-II haplotypes play no role in gamete association in Atlantic salmon and that earlier findings of MHC-based mate choice most likely reflect choice among diploid genotypes. We discuss possible explanations for these findings and how they differ from findings in mammals.

Systematic review of recent evidence for the safety and efficacy of elective endovascular repair in the management of infrarenal abdominal aortic aneurysm.

PubMed

Drury, D; Michaels, J A; Jones, L; Ayiku, L

2005-08-01

Conventional management of abdominal aortic aneurysm (AAA) is by open repair and is associated with a mortality rate of 2-6 per cent. Endovascular aneurysm repair (EVAR) is an alternative technique first introduced in 1991. A systematic review was undertaken of the evidence for the safety and efficacy of elective EVAR in the management of asymptomatic infrarenal AAA. Thirteen electronic bibliographical databases were searched, covering biomedical, health-related, science and social science literature. Outcomes were assessed with respect to efficacy (successful deployment, technical success, conversion rates and secondary intervention rates) and safety (30-day mortality rate, procedure morbidity rates and technical issues-endoleaks, graft thrombosis, stenosis and migration). Of 606 reports identified, 61 met the inclusion criteria (three randomized and 15 non-randomized controlled trials, and 43 uncontrolled studies). There were 29 059 participants in total; 19,804 underwent EVAR. Deployment was successful in 97.6 per cent of cases. Technical success (complete aneurysm exclusion) was 81.9 per cent at discharge and 88.8 per cent at 30 days. Secondary intervention to treat endoleak or maintain graft patency was required in 16.2 per cent of patients. Mean stay in the intensive care unit and mean hospital stay were significantly shorter following EVAR. The 30-day mortality rate for EVAR was 1.6 per cent (randomized controlled trials) and 2.0 per cent in nonrandomized trials and case series. Technical complications comprised stent migration (4.0 per cent), graft limb thrombosis (3.9 per cent), endoleak (type I, 6.8 per cent; type II, 10.3 per cent; type III, 4.2 per cent) and access artery injury (4.8 per cent). EVAR is technically effective and safe, with lower short-term morbidity and mortality rates than open surgery. However, there is a need for extended follow-up as the long-term success of EVAR in preventing aneurysm-related deaths is not yet known.

A mobile health technology enabled home-based intervention to treat frailty in adult lung transplant candidates: A pilot study.

PubMed

Singer, Jonathan P; Soong, Allison; Bruun, Alan; Bracha, Ayana; Chin, Greg; Hays, Steven R; Kukreja, Jasleen; Rigler, Julia; Golden, Jeff A; Greenland, John R; Garvey, Chris

2018-05-09

Frailty is prevalent in lung transplant candidates (LTC) and is associated with waitlist delisting or death. We performed a pilot study to assess the safety and feasibility of a home-based, mobile-health technology facilitated intervention to treat frailty in LTC. We performed an 8-week, non-randomized, home-based exercise and nutrition intervention in LTC with Short Physical Performance Battery (SPPB) frailty scores of ≤11. The intervention utilized a customized, mobile device application ("app") enabling monitoring and progression of the intervention in real-time. We aimed to evaluate key process measures. Secondarily, we tested whether the intervention could improve frailty scores quantified by the SPPB and Fried Frailty Phenotype (FFP). 15 subjects enrolled were 63 ±5.7 years old; oxygen requirements ranged from 3-15LPM. Thirteen subjects completed the intervention. Over 108 subject-weeks there were no adverse events. Subjects found the app engaging and easy to work with. SPPB frailty improved in 7 (54%) and FFP improved in 8 (62%). There was a strong trend towards improved frailty scores (SPPB change 1.0±1.9; p=0.08; FFP change -0.6±1.0; p=0.07). In this pilot study, we found that a home-based pre-habilitation program that leverages mobile health technology to target frailty in LTC is well received, safe, and capable of improving physical frailty scores. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Nonpharmacological interventions for cognitive impairments following primary progressive aphasia: a systematic review of the literature

PubMed Central

Carthery-Goulart, Maria Teresa; da Silveira, Amanda da Costa; Machado, Thais Helena; Mansur, Leticia Lessa; Parente, Maria Alice de Mattos Pimenta; Senaha, Mirna Lie Hosogi; Brucki, Sonia Maria Dozzi; Nitrini, Ricardo

2013-01-01

This study provided a systematic review on nonpharmacological interventions applied to patients diagnosed with Primary Progressive Aphasia (PPA) and its variants: Semantic (SPPA), Nonfluent (NFPPA) and Logopenic (LPPA) to establish evidence-based recommendations for the clinical practice of cognitive rehabilitation for these patients. METHODS A PubMed and LILACS literature search with no time restriction was conducted with the keywords PPA (and its variants) AND rehabilitation OR training OR intervention OR therapy OR treatment OR effectiveness. To develop its evidence-based recommendations, a research committee identified questions to be addressed and determined the level of evidence for each study according to published criteria (Cicerone et al., 2000). Overall evidence for treatments was summarized and recommendations were derived. RESULTS Our search retrieved articles published from 1995 to 2013: 21 for SPPA, 8 for NFPPA, 3 for LPPA and 8 for PPA with no specification. Thirty-five studies were rated as Class III, consisting of studies with results obtained from one or more single-cases and that used appropriate single-subject methods with adequate quantification and analysis of results. The level of evidence of three functional interventions could not be established. One study was rated as Class II and consisted of a nonrandomized case-control investigation. CONCLUSION Positive results were reported in all reviewed studies. However, in order to be recommended, some investigation regarding the intervention efficacy was required. Results of the present review allows for recommendation of some nonpharmacological interventions for cognitive deficits following PPA as Practice Options. Suggestions for further studies on PPA interventions and future research are discussed. PMID:29213828

Tobacco use cessation and weight management among motor freight workers: Results of the Gear Up for Health Study

PubMed Central

Sorensen, Glorian; Stoddard, Anne; Quintiliani, Lisa; Ebbeling, Cara; Nagler, Eve; Yang, May; Pereira, Leslie; Wallace, Lorraine

2012-01-01

Objectives To present the results of a study of a worksite-based intervention to promote tobacco use cessation and improve weight management among motor freight workers. Methods This study used a pre-test/post-test, non-randomized design to assess the effectiveness of a four-month intervention that addressed the social context of the work setting. We evaluated 7-day tobacco quit prevalence among baseline tobacco users, and successful weight management, defined as no weight gain in workers with BMI < 25 at baseline and any weight loss among overweight and obese workers. Results At baseline, 40% were current tobacco users, and 88% had a BMI of 25 or greater. Of 542 workers invited to participate, 227 agreed to participate and received at least the first telephone call (42%). Ten months post-baseline, baseline tobacco users who participated in the intervention were more likely to have quit using tobacco than non-participants: 23.8% vs. 9.1% (p=0.02). There was no significant improvement in weight management. Conclusions Incorporating work experiences and job conditions into messages of health behavior change resulted in significant tobacco use cessation among participating motor freight workers. PMID:20725775

Tobacco use cessation and weight management among motor freight workers: results of the gear up for health study.

PubMed

Sorensen, Glorian; Stoddard, Anne; Quintiliani, Lisa; Ebbeling, Cara; Nagler, Eve; Yang, May; Pereira, Lesley; Wallace, Lorraine

2010-12-01

To present the results of a study of a worksite-based intervention to promote tobacco use cessation and improve weight management among motor freight workers. This study used a pre-test/post-test, non-randomized design to assess the effectiveness of a four-month intervention that addressed the social context of the work setting. We evaluated 7-day tobacco quit prevalence among baseline tobacco users, and successful weight management, defined as no weight gain in workers with BMI <25 at baseline and any weight loss among overweight and obese workers. At baseline, 40% were current tobacco users, and 88% had a BMI of 25 or greater. Of 542 workers invited to participate, 227 agreed to participate and received at least the first telephone call (42%). Ten-month post-baseline, baseline tobacco users who participated in the intervention were more likely to have quit using tobacco than non-participants: 23.8% vs. 9.1% (p = 0.02). There was no significant improvement in weight management. Incorporating work experiences and job conditions into messages of health behavior change resulted in significant tobacco use cessation among participating motor freight workers.

A qualitative study to explore Prospect theory and message framing and diet and cancer prevention-related issues among African American adolescents

PubMed Central

Satia, Jessie A.; Barlow, Jameta; Armstrong-Brown, Janelle; Watters, Joanne L.

2010-01-01

Aims To develop and test cancer prevention messages based on Prospect theory on motivation to improve dietary intake in African American adolescents, and to explore other salient factors that may inform dietary intervention design and implementation in this population. Methods Semi-structured in-person qualitative interviews were conducted with 13 African-American male and female adolescents, 12-16 years, in North Carolina. Prospect theory and message framing were used to guide the design of the four sets of diet-related messages related to cancer prevention: short-term gain-, long-term gain-, short-term loss-, and long-term loss-framed messages. Data were also collected on demographic, behavioral, and psychological factors; usual health behaviors; and preferences for intervention delivery. Results The majority of respondents found the gain-framed, short-term messages most salient for both fruits/vegetables (8 (61.5%)), and fat consumption (7 (53.8%)). For fat consumption only, 2 (15.4%) found the loss-framed, short-term messages pertinent; none found the loss-framed, long-term messages relevant for either dietary variable. All indicated interest in participating in a dietary intervention/education program; most preferred the Internet as a channel for intervention delivery. Participants expressed diverse views regarding knowledge, attitudes, and beliefs regarding healthy eating. Conclusions Researchers conducting dietary interventions and education initiatives and medical professionals who counsel African American adolescents should consider using Prospect Theory as a theoretical framework, should focus on gain-framed short-term messages regarding cancer prevention, and should employ the Internet for data collection and intervention and information delivery. PMID:20142738

Multifaceted Prospective Memory Intervention to Improve Medication Adherence.

PubMed

Insel, Kathie C; Einstein, Gilles O; Morrow, Daniel G; Koerner, Kari M; Hepworth, Joseph T

2016-03-01

To test whether a multifaceted prospective memory intervention improved adherence to antihypertensive medications and to assess whether executive function and working memory processes moderated the intervention effects. Two-group longitudinal randomized control trial. Community. Individuals aged 65 and older without signs of dementia or symptoms of severe depression who were self-managing prescribed medication. After 4 weeks of initial adherence monitoring using a medication event monitoring system, individuals with 90% or less adherence were randomly assigned to groups. The prospective memory intervention was designed to provide strategies that switch older adults from relying on executive function and working memory processes (that show effects of cognitive aging) to mostly automatic associative processes (that are relatively spared with normal aging) for remembering to take medications. Strategies included establishing a routine, establishing cues strongly associated with medication taking actions, performing the action immediately upon thinking about it, using a medication organizer, and imagining medication taking to enhance encoding and improve cuing. There was significant improvement in adherence in the intervention group (57% at baseline to 78% after the intervention), but most of these gains were lost after 5 months. The control condition started at 68% and was stable during the intervention, but dropped to 62%. Executive function and working memory moderated the intervention effect, with the intervention producing greater benefit for those with lower executive function and working memory. The intervention improved adherence, but the benefits were not sustained. Further research is needed to determine how to sustain the substantial initial benefits. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

The prospective impact of food pricing on improving dietary consumption: A systematic review and meta-analysis

PubMed Central

Afshin, Ashkan; Peñalvo, José L.; Del Gobbo, Liana; Silva, Jose; Michaelson, Melody; O'Flaherty, Martin; Capewell, Simon; Spiegelman, Donna; Danaei, Goodarz; Mozaffarian, Dariush

2017-01-01

Background While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. Objective To quantify the prospective effect of changes in food prices on dietary consumption. Design We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price data were collected before 1990. Data were extracted independently and in duplicate. Findings were pooled using DerSimonian-Laird's random effects model. Pre-specified sources of heterogeneity were analyzed using meta-regression; and potential for publication bias, by funnel plots, Begg's and Egger's tests. Results From 3,163 identified abstracts, 23 interventional studies and 7 prospective cohorts with 37 intervention arms met inclusion criteria. In pooled analyses, a 10% decrease in price (i.e., subsidy) increased consumption of healthful foods by 12% (95%CI = 10–15%; N = 22 studies/intervention arms) whereas a 10% increase price (i.e. tax) decreased consumption of unhealthful foods by 6% (95%CI = 4–8%; N = 15). By food group, subsidies increased intake of fruits and vegetables by 14% (95%CI = 11–17%; N = 9); and other healthful foods, by 16% (95%CI = 10–23%; N = 10); without significant effects on more healthful beverages (-3%; 95%CI = -16-11%; N = 3). Each 10% price increase reduced sugar-sweetened beverage intake by 7% (95%CI = 3–10%; N = 5); fast foods, by 3% (95%CI = 1–5%; N = 3); and other unhealthful foods, by 9% (95%CI = 6–12%; N = 3). Changes in price of fruits and vegetables reduced body mass index (-0.04 kg/m2 per 10% price decrease, 95%CI = -0.08–0 kg/m2; N = 4); price changes for sugar-sweetened beverages or fast foods did not significantly alter body mass index, based on 4 studies. Meta-regression identified direction of price change (tax vs. subsidy), number of intervention components, intervention duration, and study quality score as significant sources of heterogeneity (P-heterogeneity<0.05 each). Evidence for publication bias was not observed. Conclusions These prospective results, largely from interventional studies, support efficacy of subsidies to increase consumption of healthful foods; and taxation to reduce intake of unhealthful beverages and foods. Use of subsidies and combined multicomponent interventions appear most effective. PMID:28249003

C-A1-01: Changes in Physical Activity and Nutrition in a Behavioral Intervention Pilot Study - Passport to Brain Wellness

PubMed Central

Hanson, Leah R; Martinson, Brian C; Sherwood, Nancy E; Crain, A Lauren; Hayes, Marcia G; O’Connor, Patrick J; Matthews, Rachel B; Cooner, Jacob M

2010-01-01

Background/Aims: Increasing concerns about cognitive decline and dementia in the aging populations of most westernized countries suggests the need for interventions that can preserve cognitive function, are cost-effective, and feasibly implemented on a large scale. Empirical evidence is accumulating that points to the potential beneficial effects of cardiovascular fitness, healthy diet, social integration and participation in cognitively stimulating activities in the maintenance of cognitive function. We have developed and pilot tested “Passport,” a multi-component, cognitive-behavioral, phone and mail based intervention to promote such lifestyle changes in older adults. Methods: Cognitively intact (TICS ≥ 31), sedentary (<90 min physical activity[PA] per week) adults aged 61–80 years were recruited from among HealthPartners’ members. Baseline assessments included cognitive function, biomarkers, lifestyle factors, and physical traits. In the first phase, 21 participants were recruited and all assigned (non-randomized) to receive a course book, pedometer, tool kit and 7 bi-weekly phone coaching calls. In the second phase, 42 participants were recruited and randomized to either the Guided Intervention (n=22) or a Self-Directed (n=20) group, who received the study materials but no coaching. We completed 6 month follow-up measures with 58 (92%) subjects, and report here on their PA and nutritional outcomes. Results: The 63 enrolled subjects were female (60%), 70 years old, highly educated (73% college or more), predominantly retired (81%), non-Hispanic White (71%;) and married (65%). On average, they were overweight, BMI M=29.8, normotensive, systolic BP M=122.8, and normocholesterolemic, total serum cholesterol M=189.3. Mixed-model analyses indicated a time*treatment group effect on objectively monitored MVPA (p<.05), with a significant increase in the guided group (7.3 to 16.5mins/day, p<.05). We observed a significant effect of time on saturated fat intake (p<.05), with a significant pre-post reduction among Guided participants (26.1 to 23.4 grams, p<.05). Similar patterns of effects were observed for intake of fruits, vegetables and dietary fiber. Finally, we observed a time effect on intake of fish high in omega-3 fatty acids, driven by an increase in the non-randomized group (p<.05). Conclusions: Passport shows promise for improving aspects of lifestyle behaviors hypothesized to be important for the primary prevention of cognitive decline in older adults.

Mild cognitive impairment and prospective memory: translating the evidence into neuropsychological practice.

PubMed

Kinsella, Glynda J; Pike, Kerryn E; Cavuoto, Marina G; Lee, Stephen D

2018-04-30

There has been a recent rapid development of research characterizing prospective memory performance in mild cognitive impairment (MCI) in older age. However, this body of literature remains largely separated from routine clinical practice in neuropsychology. Furthermore, there is emerging evidence of effective interventions to improve prospective memory performance. Therefore, our objective in this article was to offer a clinical neuropsychological perspective on the existing research in order to facilitate the translation of the evidence-base into clinical practice. By conducting a critical review of the existing research related to prospective memory and MCI, we highlight how this data can be introduced into clinical practice, either within diagnostic assessment or clinical management. Prospective memory is impaired in older adults with MCI, with a pattern of performance that helps with differential diagnosis from healthy aging. Clinical neuropsychologists are encouraged to add prospective memory assessment to their toolbox for diagnostic evaluation of clients with MCI. Preliminary findings of prospective memory interventions in MCI are promising, but more work is required to determine how different approaches translate to increasing independence in everyday life.

Feasibility of a Telehealth Educational Program on Self-Management of Pain and Fatigue in Adult Cancer Patients.

PubMed

Rocque, Gabrielle B; Halilova, Karina I; Varley, Allyson L; Williams, Courtney P; Taylor, Richard A; Masom, David G; Wright, William J; Partridge, Edward E; Kvale, Elizabeth A

2017-06-01

Pain and fatigue are common symptoms among cancer patients and often lead to substantial distress. Innovative self-management programs for pain and fatigue are needed. The primary objective was to assess the feasibility of a telehealth pain and fatigue self-management program among adult cancer patients. Secondary objectives included assessment of differences in patient characteristics, recruitment, and retention of patients based on two screening strategies: 1) navigator-collected, patient-reported pain or fatigue and 2) in-clinic, physician-identified pain or fatigue. This prospective, nonrandomized, pre-post evaluation assessed feasibility, which was defined as 50% of eligible patients choosing to participate and completing the intervention. Patient demographics and patient-reported outcomes (patient activation, distress, symptoms, and quality of life) were collected at baseline and study completion. Differences in baseline characteristics were compared between cohorts and for patients who did vs. did not graduate from the program. The program did not meet feasibility requirements because of only 34% of eligible patients choosing to participate. However, 50% of patients starting the program graduated. Differences in baseline characteristics and retention rates were noted by recruitment strategy. At baseline, 27.3% of navigated patients were at the highest activation level compared with 7.1% in the physician-referred, non-navigated patients (P = 0.17); more than 15% of non-completers were at the lowest activation level compared with 9% of completers (P = 0.85). Telehealth self-management program for pain and fatigue may be better accepted among selected segments of cancer patients. Larger scale studies are needed to assess the efficacy of this program in a more selective activated population. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Single-Sided Deafness: Impact of Cochlear Implantation on Speech Perception in Complex Noise and on Auditory Localization Accuracy.

PubMed

Döge, Julia; Baumann, Uwe; Weissgerber, Tobias; Rader, Tobias

2017-12-01

To assess auditory localization accuracy and speech reception threshold (SRT) in complex noise conditions in adult patients with acquired single-sided deafness, after intervention with a cochlear implant (CI) in the deaf ear. Nonrandomized, open, prospective patient series. Tertiary referral university hospital. Eleven patients with late-onset single-sided deafness (SSD) and normal hearing in the unaffected ear, who received a CI. All patients were experienced CI users. Unilateral cochlear implantation. Speech perception was tested in a complex multitalker equivalent noise field consisting of multiple sound sources. Speech reception thresholds in noise were determined in aided (with CI) and unaided conditions. Localization accuracy was assessed in complete darkness. Acoustic stimuli were radiated by multiple loudspeakers distributed in the frontal horizontal plane between -60 and +60 degrees. In the aided condition, results show slightly improved speech reception scores compared with the unaided condition in most of the patients. For 8 of the 11 subjects, SRT was improved between 0.37 and 1.70 dB. Three of the 11 subjects showed deteriorations between 1.22 and 3.24 dB SRT. Median localization error decreased significantly by 12.9 degrees compared with the unaided condition. CI in single-sided deafness is an effective treatment to improve the auditory localization accuracy. Speech reception in complex noise conditions is improved to a lesser extent in 73% of the participating CI SSD patients. However, the absence of true binaural interaction effects (summation, squelch) impedes further improvements. The development of speech processing strategies that respect binaural interaction seems to be mandatory to advance speech perception in demanding listening situations in SSD patients.

Rebubbling in Descemet Membrane Endothelial Keratoplasty: Influence of Pressure and Duration of the Intracameral Air Tamponade.

PubMed

Pilger, Daniel; Wilkemeyer, Ina; Schroeter, Jan; Maier, Anna-Karina B; Torun, Necip

2017-06-01

To explore the impact of intracameral air tamponade pressure and duration on graft attachment and rebubbling rates. A prospective, interventional, nonrandomized study. setting: Department of Ophthalmology, Charité - Universitätsmedizin Berlin. One hundred seventeen patients who underwent Descemet membrane endothelial keratoplasty (DMEK). Intraocular pressure (IOP) at the end of the surgery, immediately after filling the anterior chamber with air, categorized into low (<10 mm Hg), normal (10-20 mm Hg), and high (>20 mm Hg), and the time until partial removal of the air. Rebubbling rates and endothelial cell density over a 3-month follow-up period analyzed by a multivariable Cox regression model and an analysis of covariance model. Thirty-two patients required a rebubbling (27% [95% CI 19%-35%]). Nine patients required more than 1 rebubbling (7% [95% CI 3%-12%]). Compared with normal IOP, lower (HR 8.98 [95% CI 1.07-75.41]) and higher IOP (HR 10.63 [95% CI 1.44-78.27]) increased the risk of requiring a rebubbling (P = .006). Independent of the IOP, an air tamponade duration beyond 2 hours reduced the risk of rebubbling (HR 0.36 [95% CI 0.18-0.71, P = .003]). One month after surgery, the mean endothelial cell loss was 13% (95% CI 2%-25%) and 23% (95% CI 17%-29%) in the group with air tamponade duration of below and above 2 hours, respectively (P = .126). At 3 months after surgery, it was 31% (95% CI 17%-42%) and 42% (95% CI 32%-52%) in the respective groups (P = .229). A postsurgical air tamponade of at least 2 hours with an IOP within the physiological range could help to reduce rebubbling rates. Copyright © 2017 Elsevier Inc. All rights reserved.

Micro-instillation of fluorescein with an inoculation loop for ocular surface staining in dry eye syndrome.

PubMed

Courrier, Emilie; Renault, Didier; Kaspi, Mathilde; Marcon, Agathe; Lambert, Victor; Garcin, Thibaud; Chiambaretta, Frederic; Garhofer, Gerhard; Thuret, Gilles; Gain, Philippe

2018-03-01

To describe and validate the micro-instillation of fluorescein on the ocular surface by a disposable calibrated inoculation loop to improve corneal and conjunctival staining quality. Accuracy and precision of the volume of 0.5% sodium fluorescein collected by a single use 1 μl-calibrated inoculation loop were measured using a precision balance. Twenty patients (40 eyes) suffering from dry eye syndrome were enrolled in a prospective interventional nonrandomized study. Fluorescein was instilled with the loop, and slit-lamp images were taken within 30 seconds using cobalt blue light with and without a yellow barrier filter. For comparison, after a washout period, the same images were retaken after instillation of one drop of fluorescein from a single-dose unit. The main outcome measure was the staining quality assessed by three experts, blind to the instillation method. Patient discomfort (tolerance, by a questionnaire) was also compared. The mean volume collected by the loop was 1.18 ± 0.12 μl, compared with 33.70 ± 6.10 μl using the single-dose unit. The loop avoided excess dye responsible for unpleasant tearing, masking of lesions and rapid diffusion into the stroma. Micro-instillation greatly improved image quality without losing information. The yellow filter further improved image contrast. Tolerance was excellent. The 1 μl-calibrated inoculation loop is a safe, convenient, inexpensive, disposable, sterile, well-tolerated tool for reproducible micro-instillation of commercial fluorescein. By greatly improving staining quality, it will help standardize assessment of dry eye severity. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Reduction in operator radiation exposure during transradial coronary procedures using a simple lead rectangle.

PubMed

Osherov, Azriel B; Bruoha, Sharon; Laish Farkash, Avishag; Paul, Gideon; Orlov, Ian; Katz, Amos; Jafari, Jamal

2017-02-01

Transradial access for percutaneous coronary intervention (PCI) reduces procedural complications however, there are concerns regarding the potential for increased exposure to ionizing radiation to the primary operator. We evaluated the efficacy of a lead-attenuator in reducing radiation exposure during transradial PCI. This was a non-randomized, prospective, observational study in which 52 consecutive patients were assigned to either standard operator protection (n = 26) or the addition of the lead attenuator across their abdomen/pelvis (n = 26). In the attenuator group patients were relatively older with a higher prevalence of peripheral vascular disease (67.9 vs 58.7 p = 0.0292 and 12% vs 7.6% p < 0.001 respectively). Despite similar average fluoroscopy times (12.3 ± 9.8 min vs. 9.3 ± 5.4 min, p = 0.175) and average examination doses (111866 ± 80790 vs. 91,268 ± 47916 Gycm 2 , p = 0.2688), the total radiation exposure to the operator, at the thyroid level, was significantly lower when the lead-attenuator was utilized (20.2% p < 0.0001) as compared to the control group. Amongst the 26 patients assigned to the lead-attenuator, there was a significant reduction in measured radiation of 94.5% (p < 0.0001), above as compared to underneath the lead attenuator. Additional protection with the use of a lead rectangle-attenuator significantly lowered radiation exposure to the primary operator, which may confer long-term benefits in reducing radiation-induced injury. This is the first paper to show that a simple lead attenuator almost completely reduced the scattered radiation at very close proximity to the patient and should be considered as part of the standard equipment within catheterization laboratories.

Keratocyte density 3 months, 15 months, and 3 years after corneal surface ablation with mitomycin C.

PubMed

de Benito-Llopis, Laura; Cañadas, Pilar; Drake, Pilar; Hernández-Verdejo, José Luis; Teus, Miguel A

2012-01-01

To study the effects of surface ablation with mitomycin C (MMC) on keratocyte population. Prospective, nonrandomized, interventional, comparative case series. Thirty two eyes treated with surface ablation with 0.02% MMC were compared with nontreated eyes at Vissum Santa Hortensia, Madrid, Spain. Keratocyte density was measured with the Heidelberg Retina Tomograph II (Rostock Cornea Module) 3, 15, and 36 to 42 months after the surgery in the anterior, mid, and posterior stroma, and compared with control eyes. Three months postoperatively, we found a lower stromal bed density compared to controls (16 993 ± 8001 vs 29 660 ± 5904 cells/mm(3), P = .0001), while there was a significantly higher cell density in the mid (30 783 ± 9300 vs 18 505 ± 1996 cells/mm(3), P = .0001) and deep stroma (30 268 ± 8321 vs 18 438 ± 2139 cells/mm(3), P = .0001). Three years after the surgery, the cellularity in the stromal bed had not significantly changed from the 3-month follow-up, but the density in the mid (18 889 ± 3474 cells/mm(3)) and posterior stroma (18 992 ± 3402 cells/mm(3)) had decreased to show no difference from controls. The mean cell density between the anterior, mid, and posterior stroma was not significantly different from controls 15 months and 3 years after the surgery. Our study suggests that there is a reorganization of the stromal cell population soon after surface ablation with MMC, with a decrease in the stromal bed compensated initially with an increase in the mid and posterior stroma. Corneal cellularity tends to normalize over time, and 3 years postoperatively the mean cell density throughout the cornea seems to maintain normal values. Copyright © 2012 Elsevier Inc. All rights reserved.

The Impact of a Cognitive Behavioral Pain Management Program on Sleep in Patients with Chronic Pain: Results of a Pilot Study.

PubMed

Blake, Catherine; Cunningham, Jennifer; Power, Camillus K; Horan, Sheila; Spencer, Orla; Fullen, Brona M

2016-02-01

To determine the impact of a cognitive behavioral pain management program on sleep in patients with chronic pain. Prospective nonrandomized controlled pilot study with evaluations at baseline and 12 weeks. Out-patient multidisciplinary cognitive behavioral pain management program in a university teaching hospital. Patients with chronic pain who fulfilled the criteria for participation in a cognitive behavioral pain management program. Patients assigned to the intervention group (n = 24) completed a 4 week cognitive behavioral pain management program, and were compared with a waiting list control group (n = 22). Assessments for both groups occurred at baseline and two months post cognitive behavioral pain management program. Outcome measures included self-report (Pittsburgh Sleep Quality Index) and objective (actigraphy) sleep measures, pain and quality of life measures. Both groups were comparable at baseline, and all had sleep disturbance. The Pittsburgh Sleep Quality Index correlated with only two of the seven objective sleep measures (fragmentation index r = 0.34, P = 0.02, and sleep efficiency percentage r = -0.31, P = 0.04). There was a large treatment effect for cognitive behavioral pain management program group in mean number of wake bouts (d = 0.76), where a significant group*time interaction was also found (P = 0.016), showing that the CBT-PMP group improved significantly more than controls in this sleep variable. Patients attending a cognitive behavioral pain management program have high prevalence of sleep disturbance, and actigraphy technology was well tolerated by the patients. Preliminary analysis of the impact of a cognitive behavioral pain management program on sleep is promising, and warrants further investigation.

Time to consider the contact force during photoplethysmography measurement during pediatric anesthesia: A prospective, nonrandomized interventional study.

PubMed

Lee, Ji-Hyun; Yang, Seungman; Park, Jonghyun; Kim, Hee Chan; Kim, Eun-Hee; Jang, Young-Eun; Kim, Jin-Tae; Kim, Hee-Soo

2018-06-19

Respiratory variations in photoplethysmography amplitude enable volume status assessment. However, the contact force between the measurement site and sensor can affect photoplethysmography waveforms. We aimed to evaluate contact force effects on respiratory variations in photoplethysmography waveforms in children under general anesthesia. Children aged 3-5 years were enrolled. After anesthetic induction, mechanical ventilation commenced at a tidal volume of 10 mL/kg. Photoplethysmographic signals were obtained in the supine position from the index finger using a force sensor-integrated clip-type photoplethysmography sensor that increased the contact force from 0-1.4 N for 20 respiratory cycles at each force. The AC amplitude (pulsatile component), DC amplitude (nonpulsatile component), AC/DC ratio, and respiratory variations in photoplethysmography amplitude were calculated. Data from 34 children were analyzed. Seven contact forces at 0.2-N increments were evaluated for each patient. The normalized AC amplitude increased maximally at a contact force of 0.4-0.6 N and decreased with increasing contact force. However, the normalized DC amplitude increased with a contact force exceeding 0.4 N. ΔPOP decreased slightly and increased from the point when the AC amplitude started to decrease as contact force increased. In a 0.2-1.2 N contact force range, significant changes in the normalized AC amplitude, normalized DC amplitude, AC/DC ratio, and respiratory variations in photoplethysmography amplitude were observed. Respiratory variations in photoplethysmography amplitude changed according to variable contact forces; therefore, these measurements may not reflect respiration-induced stroke volume variations. Clinicians should consider contact force bias when interpreting morphological data from photoplethysmography signals. © 2018 John Wiley & Sons Ltd.

Teaching residents to use asthma devices. Assessing family residents' skills and a brief intervention.

PubMed Central

Kelcher, S.; Brownoff, R.

1994-01-01

OBJECTIVE: To evaluate an educational program for family medicine residents on using selected inhaler devices for delivery of asthma medications. DESIGN: A prospective analysis using pretests and posttests of a nonrandomized study group and control group. The study group of residents was given an instructional manual and a set of devices for home study, followed by a 1-hour tutorial session with a clinical instructor that included a video and hands-on practice. SETTING: Family medicine centres in Edmonton hospitals. PARTICIPANTS: The study group consisted of a convenience sample of 23 first- and second-year family medicine residents at the Misericordia Hospital Family Medicine Centre. The control group consisted of a convenience sample of 22 first- and second-year family medicine residents at the Royal Alexandra Hospital Family Medicine Centre. Nine residents did not take the posttest; one was absent because of injury, one missed the in-service, and seven had left the city on other rotations, had completed their program, or declined to participate. MAIN OUTCOME MEASURES: Improvements in scores on a multiple-choice test and in techniques of using the devices. RESULTS: Using an average of scores on seven different devices, only 36% of residents showed adequate knowledge of how to use the devices on the pretest. Posttest scores improved for both the control (P < 0.001) and study (P < 0.001) groups, but improvement was significantly greater for the study group (P < 0.001). CONCLUSIONS: Residents lacked adequate knowledge of asthma devices. More study is needed to confirm the long-term effectiveness of formal teaching about the devices. Images Figure 1 PMID:7888821

Effectiveness of intense, activity-based physical therapy for individuals with spinal cord injury in promoting motor and sensory recovery: Is olfactory mucosa autograft a factor?

PubMed Central

Larson, Cathy A.; Dension, Paula M.

2013-01-01

Background/objectives Rehabilitation for individuals with spinal cord injury (SCI) is expanding to include intense, activity-based, out-patient physical therapy (PT). The study's primary purposes were to (i) examine the effectiveness of intense PT in promoting motor and sensory recovery in individuals with SCI and (ii) compare recovery for individuals who had an olfactory mucosa autograft (OMA) with individuals who did not have the OMA while both groups participated in the intense PT program. Methods Prospective, non-randomized, non-blinded, intervention study. Using the American Spinal Injury Association examination, motor and sensory scores for 23 (7 OMA, 6 matched control and 10 other) participants were recorded. Results Mean therapy dosage was 137.3 total hours. The participants’ total, upper and lower extremity motor scores improved significantly while sensory scores did not improve during the first 60 days and from initial to discharge examination. Incomplete SCI or paraplegia was associated with greater motor recovery. Five of 14 participants converted from motor-complete to motor-incomplete SCI. Individuals who had the OMA and participated in intense PT did not have greater sensory or greater magnitude or rate of motor recovery as compared with participants who had intense PT alone. Conclusion This study provides encouraging evidence as to the effectiveness of intense PT for individuals with SCI. Future research is needed to identify the optimal therapy dosage and specific therapeutic activities required to generate clinically meaningful recovery for individuals with SCI including those who elect to undergo a neural recovery/regenerative surgical procedure and those that elect intense therapy alone. PMID:23433335

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention.

PubMed

Zoellner, Jamie M; Porter, Kathleen J; Chen, Yvonnes; Hedrick, Valisa E; You, Wen; Hickman, Maja; Estabrooks, Paul A

2017-05-01

Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13-20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6-38%) and behaviour (average 30%, range 6-55%) were significant. Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases.

Contrast media extravasations in patients undergoing computerized tomography scanning: a systematic review and meta-analysis of risk factors and interventions.

PubMed

Ding, Sandrine; Meystre, Nicole Richli; Campeanu, Cosmin; Gullo, Giuseppe

2018-01-01

To identify risk factors and interventions preventing or reducing contrast medium extravasation. Computed tomography (CT) is a radiological examination essential for the diagnosis and monitoring of many diseases. It is often performed with the intravenous (IV) injection of contrast agents. Use of these products can result in a significant complication, extravasation, which is the accidental leakage of IV material into the surrounding tissue. Patients may feel a sharp pain and skin ulceration or necrosis may develop. This review considered studies that included patients (adults and children) undergoing a CT with IV administration of contrast media. The risk factors considered were patient demographics, comorbidities and medication history. This review also investigated any strategies related to: contrast agent, injection per se, material used for injection, apparatus used, healthcare professionals involved, and patient risk assessment performed by the radiology personnel. The comparators were other interventions or usual care. This review investigated randomized controlled trials and non-randomized controlled trials. When neither of these were available, other study designs, such as prospective and retrospective cohort studies, case-control studies and case series, were considered for inclusion. Primary outcomes considered were: extravasation frequency, volume, severity and complications. The databases PubMed, CINAHL, Embase, the Cochrane Register of Controlled Trials, Web of Science PsycINFO, ProQuest Dissertations and Theses A&I, TRIP Database and ClinicalTrials.gov were searched to find both published and unpublished studies from 1980 to September 2016. Papers were assessed by two independent reviewers for methodological validity using the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). Data were extracted using the standardized data extraction tool from JBI SUMARI. In one case, quantitative data from two cohort studies were pooled in a statistical meta-analysis. However, generally, statistical pooling was not possible due to heterogeneity of the interventions, populations of interest or outcomes. Accordingly, the findings have been presented in narrative form. Fifteen articles were selected from a total of 2151 unique studies identified. Two were randomized controlled trials and 13 were quasi-experimental and observational studies. The quality of these studies was judged to be low to moderate. Some patient characteristics, such as female sex and inpatient status, appeared to be risk factors for extravasation. Additionally, injection rate, venous access site and catheter dwelling time could affect the volume extravasated. Preliminary studies seemed to indicate the potential of extravasation detection accessories to identify extravasation and reduce the volume extravasated. The other interventions either did not result in significant reduction in the frequency/volume of extravasation, or the results were mixed across the studies. The majority of the studies included in this review evaluated the outcomes of extravasation frequency and volume. Given the quality of the primary studies, this systematic review identified only potential risk factors and interventions. It further highlighted the research gap in this area and the importance of conducting trials with solid methodological designs.

Perinatal brachial plexus palsy

PubMed Central

Andersen, John; Watt, Joe; Olson, Jaret; Van Aerde, John

2006-01-01

BACKGROUND Perinatal brachial plexus palsy (PBPP) is a flaccid paralysis of the arm at birth that affects different nerves of the brachial plexus supplied by C5 to T1 in 0.42 to 5.1 infants per 1000 live births. OBJECTIVES To identify antenatal factors associated with PBPP and possible preventive measures, and to review the natural history as compared with the outcome after primary or secondary surgical interventions. METHODS A literature search on randomized controlled trials, systematic reviews and meta-analyses on the prevention and treatment of PBPP was performed. EMBASE, Medline, CINAHL and the Cochrane Library were searched until June 2005. Key words for searches included ‘brachial plexus’, ‘brachial plexus neuropathy’, ‘brachial plexus injury’, ‘birth injury’ and ‘paralysis, obstetric’. RESULTS There were no prospective studies on the cause or prevention of PBPP. Whereas birth trauma is said to be the most common cause, there is some evidence that PBPP may occur before delivery. Shoulder dystocia and PBPP are largely unpredictable, although associations of PBPP with shoulder dystocia, infants who are large for gestational age, maternal diabetes and instrumental delivery have been reported. The various forms of PBPP, clinical findings and diagnostic measures are described. Recent evidence suggests that the natural history of PBPP is not all favourable, and residual deficits are estimated at 20% to 30%, in contrast with the previous optimistic view of full recovery in greater than 90% of affected children. There were no randomized controlled trials on nonoperative management. There was no conclusive evidence that primary surgical exploration of the brachial plexus supercedes conservative management for improved outcome. However, results from nonrandomized studies indicated that children with severe injuries do better with surgical repair. Secondary surgical reconstructions were inferior to primary intervention, but could still improve arm function in children with serious impairments. CONCLUSIONS It is not possible to predict which infants are at risk for PBPP, and therefore amenable to preventive measures. Twenty-five per cent of affected infants will experience permanent impairment and injury. If recovery is incomplete by the end of the first month, referral to a multidisciplinary team is necessary. Further research into prediction, prevention and best mode of treatment needs to be done. PMID:19030261

Designing and Evaluating Interventions to Eliminate Racial and Ethnic Disparities in Health Care

PubMed Central

Cooper, Lisa A; Hill, Martha N; Powe, Neil R

2002-01-01

A large number of factors contribute to racial and ethnic disparities in health status. Health care professionals, researchers, and policymakers have believed for some time that access to care is the centerpiece in the elimination of these health disparities. The Institute of Medicine's (IOM) model of access to health services includes personal, financial, and structural barriers, health service utilization, and mediators of care. This model can be used to describe the interactions among these factors and their impact on health outcomes and equity of services among racial and ethnic groups. We present a modified version of the IOM model that incorporates the features of other access models and highlights barriers and mediators that are relevant for interventions designed to eliminate disparities in U.S. health care. We also suggest that interventions to eliminate disparities and achieve equity in health care services be considered within the broader context of improving quality of care. Some health service intervention studies have shown improvements in the health of disadvantaged groups. If properly designed and implemented, these interventions could be used to reduce health disparities. Successful features of interventions include the use of multifaceted, intense approaches, culturally and linguistically appropriate methods, improved access to care, tailoring, the establishment of partnerships with stakeholders, and community involvement. However, in order to be effective in reducing disparities in health care and health status, important limitations of previous studies need to be addressed, including the lack of control groups, nonrandom assignment of subjects to experimental interventions, and use of health outcome measures that are not validated. Interventions might be improved by targeting high-risk populations, focusing on the most important contributing factors, including measures of appropriateness and quality of care and health outcomes, and prioritizing dissemination efforts. PMID:12133164

Effectiveness of an evidence-based practice (EBP) course on the EBP competence of undergraduate nursing students: A quasi-experimental study.

PubMed

Ruzafa-Martínez, María; López-Iborra, Lidón; Armero Barranco, David; Ramos-Morcillo, Antonio Jesús

2016-03-01

International nursing institutions and experts recommend evidence-based practice (EBP) as a core component of the curriculum for nurses. However, the impact of EBP training on the competence of undergraduate nursing students remains unclear. To evaluate the effectiveness of an EBP course on the EBP competence undergraduate nursing students'. Quasi-experimental study carried out in non-randomized intervention and control groups. The study was conducted in a Spanish public university in 2010. Out of 420 second- and third-year nursing students, 75 were enrolled in the EBP course, forming the intervention group, and 73 were not enrolled in this course were recruited as controls. The educational intervention was a 15-week course designed to teach EBP competence. The EBP Competence Questionnaire (EBP-COQ) was administered before and after the intervention. Repeated-measure ANOVA was used to compare intervention and control group scores before and at two months after the 15-week intervention period. At 2months after the EBP course, mean EBP-COQ scores of the intervention group were significantly improved versus baseline in attitude (4.28 vs. 3.33), knowledge (3.92 vs. 2.82) and skills (4.01 vs. 2.75) dimensions, whereas little change was observed in control group scores over the same time period. Repeated-measures ANOVA revealed a significant effect of Time ×Group interaction on global competence and all three EBP-COQ dimensions. Undergraduate nursing students experience positive changes in EBP competence, knowledge, skills, and attitude as the result of a 15-week educational intervention on EBP. This EBP course may provide nursing school educators and policymakers with a useful model for integrating EBP teaching within the nursing curriculum. Copyright © 2015 Elsevier Ltd. All rights reserved.

A systematic review of interventions conducted in clinical or community settings to improve dual-task postural control in older adults

PubMed Central

Agmon, Maayan; Belza, Basia; Nguyen, Huong Q; Logsdon, Rebecca G; Kelly, Valerie E

2014-01-01

Background Injury due to falls is a major problem among older adults. Decrements in dual-task postural control performance (simultaneously performing two tasks, at least one of which requires postural control) have been associated with an increased risk of falling. Evidence-based interventions that can be used in clinical or community settings to improve dual-task postural control may help to reduce this risk. Purpose The aims of this systematic review are: 1) to identify clinical or community-based interventions that improved dual-task postural control among older adults; and 2) to identify the key elements of those interventions. Data sources Studies were obtained from a search conducted through October 2013 of the following electronic databases: PubMed, CINAHL, PsycINFO, and Web of Science. Study selection Randomized and nonrandomized controlled studies examining the effects of interventions aimed at improving dual-task postural control among community-dwelling older adults were selected. Data extraction All studies were evaluated based on methodological quality. Intervention characteristics including study purpose, study design, and sample size were identified, and effects of dual-task interventions on various postural control and cognitive outcomes were noted. Data synthesis Twenty-two studies fulfilled the selection criteria and were summarized in this review to identify characteristics of successful interventions. Limitations The ability to synthesize data was limited by the heterogeneity in participant characteristics, study designs, and outcome measures. Conclusion Dual-task postural control can be modified by specific training. There was little evidence that single-task training transferred to dual-task postural control performance. Further investigation of dual-task training using standardized outcome measurements is needed. PMID:24741296

A Preliminary Study on the Effectiveness of Exergame Nintendo "Wii Fit Plus" on the Balance of Nursing Home Residents.

PubMed

Janssen, Sacha; Tange, Huibert; Arends, Rachele

2013-04-01

This study investigated the effect of playing Nintendo(®) "Wii Fit™ Plus" (Nintendo of America, Inc., Redmond, WA) on body balance and physical activity of nursing home residents. In a nonrandomized controlled trial within a nursing home, two intervention groups (both n=8) were exposed to the same treatment and compared with a control group (n=13). Intervention Group 1 consisted of elderly individuals with regular Nintendo "Wii Fit" experience for at least 1 year. Elderly persons who were novices to the Nintendo "Wii Fit (Plus)" participated in intervention Group 2. Control participants had no experience with the Nintendo "Wii Fit (Plus)" and did not participate in the Nintendo "Wii Fit Plus" sessions. Outcome measurements were taken at baseline and after the intervention, using the Berg Balance Scale and the LASA Physical Activity Questionnaire. Participants of both intervention groups played the Nintendo "Wii Fit Plus" for 10 minutes twice a week during 12 weeks. Although balance improved for all three groups, there was no effect of playing "Wii Fit Plus" (P=0.89). On physical activity, the intervention did have a positive effect (P=0.005); physical activity levels increased with a median of 54.3 (interquartile range, 63.1) minutes/day for intervention Group 1 and a median of 60.7 (interquartile range, 56.8) minutes/day for intervention Group 2. This study showed an effect of Nintendo "Wii Fit Plus" gaming on physical activity of nursing home residents, but not on their balance. The effect of physical activity should be consolidated in a randomized controlled trial in a broader population.

Impact of a community based health-promotion programme in 2- to 9-year-old children in Europe on markers of the metabolic syndrome, the IDEFICS study.

PubMed

Mårild, S; Russo, P; Veidebaum, T; Tornaritis, M; De Henauw, S; De Bourdeaudhuij, I; Molnár, D; Moreno, L A; Bramsved, R; Peplies, J; Ahrens, W

2015-12-01

One objective of 'Identification and prevention of Dietary-and lifestyle-induced health EFfects In Children and infantS', the IDEFICS study, was to implement a community-oriented childhood obesity prevention intervention in eight European countries. To assess the effect of an obesity primary prevention programme on metabolic markers. The study had a non-randomized cluster-experimental design. In each country, children were recruited from distinct communities serving as intervention and control regions. Health examinations were done during 2007-2008 before the intervention (T0 ) and during 2009-2010 (T1 ). Children with results available from T0 and T1 on blood pressure, waist circumference and at least one blood-marker (fasting glucose, insulin, HOMA-IR, HbA1c, HDL- and LDL-cholesterol, triglycerides, C-reactive protein) were included. A metabolic syndrome (MetS) score was calculated. A total of 7,406 children (age 2-9.9 years) of the 16,228 participating at T0 provided the necessary data. No effect of the intervention was seen on insulin, HOMA-IR, CRP or the MetS score. Overall fasting glucose increased less in the intervention than in the control region, a pattern driven by three of the eight countries and more pronounced in children of parents with low education. Overall, HbA1c and waist circumference increased more and blood pressure less in the intervention regions. We observed no convincing effect of the intervention on markers of the metabolic syndrome. We identified diverse patterns of change for several markers of uncertain relation to the intervention. © 2015 World Obesity.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

Code of Federal Regulations, 2010 CFR

2010-10-01

... prepayment complex medical review for that provider or supplier may be extended. However, if the number of... complex medical review. 421.505 Section 421.505 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... § 421.505 Termination and extension of non-random prepayment complex medical review. (a) Timeframe that...

Variation of mutational burden in healthy human tissues suggests non-random strand segregation and allows measuring somatic mutation rates.

PubMed

Werner, Benjamin; Sottoriva, Andrea

2018-06-01

The immortal strand hypothesis poses that stem cells could produce differentiated progeny while conserving the original template strand, thus avoiding accumulating somatic mutations. However, quantitating the extent of non-random DNA strand segregation in human stem cells remains difficult in vivo. Here we show that the change of the mean and variance of the mutational burden with age in healthy human tissues allows estimating strand segregation probabilities and somatic mutation rates. We analysed deep sequencing data from healthy human colon, small intestine, liver, skin and brain. We found highly effective non-random DNA strand segregation in all adult tissues (mean strand segregation probability: 0.98, standard error bounds (0.97,0.99)). In contrast, non-random strand segregation efficiency is reduced to 0.87 (0.78,0.88) in neural tissue during early development, suggesting stem cell pool expansions due to symmetric self-renewal. Healthy somatic mutation rates differed across tissue types, ranging from 3.5 × 10-9/bp/division in small intestine to 1.6 × 10-7/bp/division in skin.

DNA asymmetry in stem cells – immortal or mortal?

PubMed Central

Yadlapalli, Swathi; Yamashita, Yukiko M.

2013-01-01

Summary The immortal strand hypothesis proposes that stem cells retain a template copy of genomic DNA (i.e. an ‘immortal strand’) to avoid replication-induced mutations. An alternative hypothesis suggests that certain cells segregate sister chromatids non-randomly to transmit distinct epigenetic information. However, this area of research has been highly controversial, with conflicting data even from the same cell types. Moreover, historically, the same term of ‘non-random sister chromatid segregation’ or ‘biased sister chromatid segregation’ has been used to indicate distinct biological processes, generating a confusion in the biological significance and potential mechanism of each phenomenon. Here, we discuss the models of non-random sister chromatid segregation, and we explore the strengths and limitations of the various techniques and experimental model systems used to study this question. We also describe our recent study on Drosophila male germline stem cells, where sister chromatids of X and Y chromosomes are segregated non-randomly during cell division. We aim to integrate the existing evidence to speculate on the underlying mechanisms and biological relevance of this long-standing observation on non-random sister chromatid segregation. PMID:23970416

Reduced Suprathreshold Odor Identification in Patients with Pseudotumor Cerebri: A Non-Randomized Prospective Study.

PubMed

Dotan, Gad; Cohen, Eyal; Klein, Ainat; Kesler, Anat

2018-01-01

Recent evidence suggests that olfaction is impaired in patients with pseudotumor cerebri (PTC). To measure suprathreshold olfactory function by using the University of Pennsylvania Smell Identification Test (UPSIT), assessing its usefulness for routine clinical use. Forty PTC patients underwent USPIT olfactory testing. Twenty-nine out of 40 (73%) PTC patients (36 women, 4 men; mean age 34 years) had reduced suprathreshold smell sensation according to UPSIT scores: 19 (47%) had mild microsmia, 9 (23%) had moderate microsmia, and one (3%) was classified as having severe microsmia. The mean UPSIT score of all patients was 32.4 (95% confidence interval 31.4-33.4). Multivariate regression analysis found that UPSIT scores were not related to disease activity, disease duration, initial intracranial pressure (ICP), or visual function. Many PTC patients have reduced suprathreshold olfactory dysfunction that can be discovered by UPSIT, a rapidly administered smell test, which is suitable for clinical office use.

Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence?

PubMed Central

Kehlet, Henrik; Aasvang, Eske Kvanner

2015-01-01

Regional anesthesia for knee and hip arthroplasty may have favorable outcome effects compared with general anesthesia by effectively blocking afferent input, providing initial postoperative analgesia, reducing endocrine metabolic responses, and providing sympathetic blockade with reduced bleeding and less risk of thromboembolic complications but with undesirable effects on lower limb motor and urinary bladder function. Old randomized studies supported the use of regional anesthesia with fewer postoperative pulmonary and thromboembolic complications, and this has been supported by recent large non-randomized epidemiological database cohort studies. In contrast, the data from newer randomized trials are conflicting, and recent studies using modern general anesthetic techniques may potentially support the use of general versus spinal anesthesia. In summary, the lack of properly designed large randomized controlled trials comparing modern general anesthesia and spinal anesthesia for knee and hip arthroplasty prevents final recommendations and calls for prospective detailed studies in this clinically important field. PMID:26918127

Treatment of lymphangiomas in children: an update of Picibanil (OK-432) sclerotherapy.

PubMed

Greinwald, J H; Burke, D K; Sato, Y; Poust, R I; Kimura, K; Bauman, N M; Smith, R J

1999-10-01

Picibanil (OK-432) is a sclerosing agent derived from a low-virulence strain of Streptococcus pyogenes that induces regression of macrocystic lymphangiomas. This report describes a prospective, nonrandomized trial to evaluate the efficacy of Picibanil in the treatment of 13 affected children ranging in age from 1 to 94 months. On average, 4.1 fluoroscopically guided intracystic injections were performed per child, with an average total dose of 0.56 mg of Picibanil. As judged by physical examination and radiographic studies, 5 children (42%) showed a complete or substantial response, and 2 children (16%) showed an intermediate response. No response was seen in 5 children (42%), 2 of whom had massive craniofacial lymphangioma. Factors that contribute to failure with Picibanil sclerotherapy are the presence of a significant microcystic component to the lesion, massive craniofacial involvement, and previous surgical resection. Macrocystic lymphangiomas of the infratemporal fossa or cervical area have the best response to therapy.

Plasticity-Driven Self-Organization under Topological Constraints Accounts for Non-random Features of Cortical Synaptic Wiring

PubMed Central

Miner, Daniel; Triesch, Jochen

2016-01-01

Understanding the structure and dynamics of cortical connectivity is vital to understanding cortical function. Experimental data strongly suggest that local recurrent connectivity in the cortex is significantly non-random, exhibiting, for example, above-chance bidirectionality and an overrepresentation of certain triangular motifs. Additional evidence suggests a significant distance dependency to connectivity over a local scale of a few hundred microns, and particular patterns of synaptic turnover dynamics, including a heavy-tailed distribution of synaptic efficacies, a power law distribution of synaptic lifetimes, and a tendency for stronger synapses to be more stable over time. Understanding how many of these non-random features simultaneously arise would provide valuable insights into the development and function of the cortex. While previous work has modeled some of the individual features of local cortical wiring, there is no model that begins to comprehensively account for all of them. We present a spiking network model of a rodent Layer 5 cortical slice which, via the interactions of a few simple biologically motivated intrinsic, synaptic, and structural plasticity mechanisms, qualitatively reproduces these non-random effects when combined with simple topological constraints. Our model suggests that mechanisms of self-organization arising from a small number of plasticity rules provide a parsimonious explanation for numerous experimentally observed non-random features of recurrent cortical wiring. Interestingly, similar mechanisms have been shown to endow recurrent networks with powerful learning abilities, suggesting that these mechanism are central to understanding both structure and function of cortical synaptic wiring. PMID:26866369

The quality of control groups in nonrandomized studies published in the Journal of Hand Surgery.

PubMed

Johnson, Shepard P; Malay, Sunitha; Chung, Kevin C

2015-01-01

To evaluate control group selection in nonrandomized studies published in the Journal of Hand Surgery American (JHS). We reviewed all papers published in JHS in 2013 to identify studies that used nonrandomized control groups. Data collected included type of study design and control group characteristics. We then appraised studies to determine whether authors discussed confounding and selection bias and how they controlled for confounding. Thirty-seven nonrandomized studies were published in JHS in 2013. The source of control was either the same institution as the study group, a different institution, a database, or not provided in the manuscript. Twenty-nine (78%) studies statistically compared key characteristics between control and study group. Confounding was controlled with matching, exclusion criteria, or regression analysis. Twenty-two (59%) papers explicitly discussed the threat of confounding and 18 (49%) identified sources of selection bias. In our review of nonrandomized studies published in JHS, papers had well-defined controls that were similar to the study group, allowing for reasonable comparisons. However, we identified substantial confounding and bias that were not addressed as explicit limitations, which might lead the reader to overestimate the scientific validity of the data. Incorporating a brief discussion of control group selection in scientific manuscripts should help readers interpret the study more appropriately. Authors, reviewers, and editors should strive to address this component of clinical importance. Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Characterization of Foci and Breakthrough Sites During Persistent and Long-Standing Persistent Atrial Fibrillation in Patients: Studies Using High-Density (510-512 Electrodes) Biatrial Epicardial Mapping.

PubMed

Lee, Seungyup; Sahadevan, Jayakumar; Khrestian, Celeen M; Markowitz, Alan; Waldo, Albert L

2017-03-17

We previously demonstrated that persistent and long-standing persistent atrial fibrillation is maintained by activation emanating from foci and breakthrough sites of different cycle lengths (CLs). The purpose of this study was to characterize the behavior of focal and nonrandom breakthrough activation identified during high-density mapping of atrial fibrillation in these patients. During open heart surgery, we recorded activation from both atria simultaneously using 510 to 512 epicardial electrodes along with ECG lead II in 12 patients with persistent and long-standing persistent atrial fibrillation. For each patient, analysis of 32 consecutive seconds of activation from identified focal (sustained and/or intermittent) and nonrandom breakthrough sites was performed. Multiple foci (sustained and/or intermittent) of different CLs were present in both atria in 11 of 12 patients; 8 foci were sustained, and 22 were intermittent. Temporal CL behavior of sustained foci varied over time (≤20 ms of the mean CL). For intermittent foci, no activation periods were due to a spontaneous pause (18 of 22) or activation of the focus by another wave front (11 of 22). All patients had breakthrough activation. Seven patients had 12 nonrandom breakthrough sites. Periods of no breakthrough activation were caused by a spontaneous pause (6 of 12 patients) or activation from another wave front (4 of 12) or were uncertain (5 of 12). Focal and nonrandom breakthrough activation sometimes produced repetitive "wannabe" (incomplete) reentry in 6 of 12 patients. During persistent and long-standing persistent atrial fibrillation, sustained foci manifested variable CLs. Spontaneous pauses or activation from other wave fronts explained the intermittency of foci and nonrandom breakthrough. Focal and nonrandom breakthrough activation occasionally produced wannabe reentry. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers

PubMed Central

Kattakuzhy, Sarah; Gross, Chloe; Emmanuel, Benjamin; Teferi, Gebeyehu; Jenkins, Veronica; Silk, Rachel; Akoth, Elizabeth; Thomas, Aurielle; Ahmed, Charisse; Espinosa, Michelle; Price, Angie; Rosenthal, Elana; Tang, Lydia; Wilson, Eleanor; Bentzen, Soren; Masur, Henry; Kottilil, Shyam

2017-01-01

Background Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection has resulted in high rates of disease cure; however, not enough specialists currently are available to provide care. Objective To determine the efficacy of HCV treatment independently provided by nurse practitioners (NPs), primary care physicians (PCPs), or specialist physicians using DAA therapy. Design Nonrandomized, open-label clinical trial initiated in 2015. (ClinicalTrials.gov: NCT02339038) Setting 13 urban, federally qualified health centers (FQHCs) in the District of Columbia. Patients A referred sample of 600 patients, of whom 96% were black, 69% were male, 82% were treatment naive, and 20% had cirrhosis. Seventy-two percent of the patients had HCV genotype 1a infection. The baseline characteristics of patients seen by each provider type were similar. Intervention Patients were assigned in a nonrandomized but specified manner to receive treatment from 1 of 5 NPs, 5 PCPs, or 6 specialists. All providers underwent an identical 3-hour training session based on guidelines. Patients received treatment with ledipasvir–sofosbuvir, which was provided on site, according to U.S. Food and Drug Administration labeling requirements. Measurements Sustained virologic response (SVR). Results 516 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Response rates were consistent across the 3 provider types: NPs, 89.3% (CI, 83.3% to 93.8%); PCPs, 86.9% (CI, 80.6% to 91.7%); and specialists, 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR. Limitation Nonrandomized patient distribution; possible referral bias. Conclusion In a real-world cohort of patients at urban FQHCs, HCV treatment administered by nonspecialist providers was as safe and effective as that provided by specialists. Nurse practitioners and PCPs with compact didactic training could substantially expand the availability of community-based providers to escalate HCV therapy, bridging existing gaps in the continuum of care for patients with HCV infection. Primary Funding Source National Institutes of Health and Gilead Sciences. PMID:28785771

Stress Management in the Health Care Setting: Matching Interventions with Patient Coping Styles.

ERIC Educational Resources Information Center

Martelli, Michael F.; And Others

1987-01-01

Prospective preprosthetic oral surgery patients were presented with a problem-focused, emotion-focused, or mixed-focus stress management intervention. The mixed-focus intervention produced the best overall response to surgery; the emotion-focused intervention produced the lowest adjustment levels. Better adjustment and satisfaction and lower…

The role of physical activity in producing and maintaining weight loss

PubMed Central

Catenacci, Victoria A; Wyatt, Holly R

2015-01-01

Summary The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss—comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose–response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed. PMID:17581621

The role of physical activity in producing and maintaining weight loss.

PubMed

Catenacci, Victoria A; Wyatt, Holly R

2007-07-01

The majority of randomized, controlled trials (RCTs) show only modest weight loss with exercise intervention alone, and slight increases in weight loss when exercise intervention is added to dietary restriction. In most RCTs, the energy deficit produced by the prescribed exercise is far smaller than that usually produced by dietary restriction. In prospective studies that prescribed high levels of exercise, enrolled individuals achieved substantially greater weight loss-comparable to that obtained after similar energy deficits were produced by caloric restriction. High levels of exercise might, however, be difficult for overweight or obese adults to achieve and sustain. RCTs examining exercise and its effect on weight-loss maintenance demonstrated mixed results; however, weight maintenance interventions were usually of limited duration and long-term adherence to exercise was problematic. Epidemiologic, cross-sectional, and prospective correlation studies suggest an essential role for physical activity in weight-loss maintenance, and post hoc analysis of prospective trials shows a clear dose-response relationship between physical activity and weight maintenance. This article reviews the role of physical activity in producing and maintaining weight loss. We focus on prospective, RCTs lasting at least 4 months; however, other prospective trials, meta-analyses and large systematic reviews are included. Limitations in the current body of literature are discussed.

Enhancing parent-child interaction with a prenatal couple intervention.

PubMed

Bryan, A A

2000-01-01

To determine the effect of a prenatal couple group intervention on parent-child interaction postbirth. Quasiexperimental study. A nonrandomized convenience sample of treatment group (TG) couples (n = 35) who attended an additional prenatal three-class series was compared to a control group (CG) from childbirth education classes on measures of videotaped parent-child interaction using the NCATS tool. The intervention class series was based on individual and couple changes in meaning/identity, roles, and relationship/interaction during the transition to parenthood. It addressed mother/father roles, infant communication abilities, and patterns of the first 3 months of life in a mutually enjoyable, possibility-focused way. T-tests and ANCOVA on NCATS scores between groups showed higher TG scores for mothers in sensitivity to cues, for fathers in social-emotional growth fostering, and for couple mean scores in social-emotional growth fostering, couple mean response to child distress, caregiver total, and caregiver-child total. Higher contingency scores were also found in the TG group. Fewer TG mothers and fathers fell below NCATS lower cutoff scores. Interventions that enhance mutual parent-child interaction through increased sensitivity to cues and responsiveness to infant needs or signals are important avenues for facilitating secure attachment, father and mother involvement, optimal development, and prevention of child abuse and neglect. The positive approach to this intervention invites couples to see themselves as developing with their infants over time, and to view their infants in new ways that will help develop satisfying, self-reinforcing patterns of interaction.

Association of TSH With Cardiovascular Disease Risk in Overweight and Obese Children During Lifestyle Intervention.

PubMed

Rijks, Jesse M; Plat, Jogchum; Dorenbos, Elke; Penders, Bas; Gerver, Willem-Jan M; Vreugdenhil, Anita C E

2017-06-01

Overweight and obese children have an increased risk to develop cardiovascular diseases (CVDs) in which thyroid-stimulating hormone (TSH) has been suggested as an intermediary factor. However, results of cross-sectional studies are inconclusive, and intervention studies investigating changes in TSH concentrations in association with changes in cardiovascular risk parameters in overweight and obese children are scarce. To gain insight in associations of circulating TSH concentrations and cardiovascular risk parameters in overweight and obese children. Nonrandomized lifestyle intervention. Centre for Overweight Adolescent and Children's Healthcare. Three hundred thirty euthyroid overweight and obese children. Long-term lifestyle intervention. TSH concentrations, pituitary TSH release in response to thyrotropin-releasing hormone (TRH), and cardiovascular risk parameters. At baseline, serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG), and monocyte chemotactic protein 1 concentrations were significantly associated with serum TSH concentrations. TSH release by the pituitary in response to exogenous TRH was not associated with cardiovascular risk parameters. During lifestyle intervention, several cardiovascular risk parameters significantly improved. In children whose body mass index z score improved, changes in TSH concentrations were significantly associated with changes in TC, LDL-C, and TAG concentrations. In euthyroid overweight and obese children, circulating TSH concentrations are positively associated with markers representing increased CVD risk. Changes in TSH concentrations are also associated with changes in lipid concentrations in children with successful weight loss, which is consistent with TSH being an intermediary factor in modulating lipid and lipoprotein metabolism. Copyright © 2017 Endocrine Society

International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer.

PubMed

Debourdeau, P; Farge, D; Beckers, M; Baglin, C; Bauersachs, R M; Brenner, B; Brilhante, D; Falanga, A; Gerotzafias, G T; Haim, N; Kakkar, A K; Khorana, A A; Lecumberri, R; Mandala, M; Marty, M; Monreal, M; Mousa, S A; Noble, S; Pabinger, I; Prandoni, P; Prins, M H; Qari, M H; Streiff, M B; Syrigos, K; Büller, H R; Bounameaux, H

2013-01-01

Although long-term indwelling central venous catheters (CVCs) may lead to pulmonary embolism (PE) and loss of the CVC, there is lack of consensus on management of CVC-related thrombosis (CRT) in cancer patients and heterogeneity in clinical practices worldwide. To establish common international Good Clinical Practices Guidelines (GCPG) for the management of CRT in cancer patients. An international working group of experts was set up to develop GCPG according to an evidence-based medicine approach, using the GRADE system. For the treatment of established CRT in cancer patients, we found no prospective randomized studies, two non-randomized prospective studies and one retrospective study examining the efficacy and safety of low-molecular-weight heparin (LMWH) plus vitamin K antagonists (VKAs). One retrospective study evaluated the benefit of CVC removal and two small retrospective studies were on thrombolytic drugs. For the treatment of symptomatic CRT, anticoagulant treatment (AC) is recommended for a minimum of 3 months; in this setting, LMWHs are suggested. VKAs can also be used, in the absence of direct comparisons of these two types of anticoagulants in this setting [Guidance]. The CVC can be kept in place if it is functional, well-positioned and non-infected and there is good resolution under close surveillance; whether the CVC is kept or removed, no standard approach in terms of AC duration has been established [Guidance]. For the prophylaxis of CRT in cancer patients, we found six randomized studies investigating the efficacy and safety of VKA vs. placebo or no treatment, one on the efficacy and safety of unfractionnated heparin, six on the value of LMWH, one double-blind randomized and one non randomized study on thrombolytic drugs and six meta-analyses of AC and CVC thromboprophylaxis. Type of catheter (open-ended like the Hickman(®) catheter vs. closed-ended catheter with a valve like the Groshong(®) catheter), its position (above, below or at the junction of the superior vena cava and the right atrium) and method of placement may influence the onset of CRT on the basis of six retrospective trials, four prospective non-randomized trials, three randomized trials and one meta-analysis. In light of these data: use of AC for routine prophylaxis of CRT is not recommended [1A]; a CVC should be inserted on the right side, in the jugular vein, and distal extremity of the CVC should be located at the junction of the superior vena cava and the right atrium [1A]. Dissemination and implementation of these international GCPG for the prevention and treatment of CRT in cancer patients at each national level is a major public health priority, needing worldwide collaboration. © 2012 International Society on Thrombosis and Haemostasis.

Neuromuscular training in construction workers: a longitudinal controlled pilot study.

PubMed

Faude, Oliver; Donath, Lars; Bopp, Micha; Hofmann, Sara; Erlacher, Daniel; Zahner, Lukas

2015-08-01

Many accidents at construction sites are due to falls. An exercise-based workplace intervention may improve intrinsic fall risk factors. In this pilot study, we aimed at evaluating the effects of neuromuscular exercise on static and functional balance performance as well as on lower limb explosive power in construction workers. Healthy middle-aged construction workers were non-randomly assigned to an intervention [N = 20, age = 40.3 (SD 8.3) years] or a control group [N = 20, age = 41.8 (9.9) years]. The intervention group performed static and dynamic balance and strength exercises (13 weeks, 15 min each day). Before and after the intervention and after an 8-week follow-up, unilateral postural sway, backward balancing (on 3- and 4.5-cm-wide beams) as well as vertical jump height were assessed. We observed a group × time interaction for postural sway (p = 0.002) with a reduction in the intervention group and no relevant change in the control group. Similarly, the number of successful steps while walking backwards on the 3-cm beam increased only in the intervention group (p = 0.047). These effects were likely to most likely practically beneficial from pretest to posttest and to follow-up test for postural sway (+12%, standardized mean difference (SMD) = 0.65 and 17%, SMD = 0.92) and backward balancing on the 3-cm beam (+58%, SMD = 0.59 and 37%, SMD = 0.40). Fifteen minutes of neuromuscular training each day can improve balance performance in construction workers and, thus, may contribute to a decreased fall risk.

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation.

PubMed

Skidmore, Elizabeth R; Dawson, Deirdre R; Whyte, Ellen M; Butters, Meryl A; Dew, Mary Amanda; Grattan, Emily S; Becker, James T; Holm, Margo B

2014-04-01

To examine the feasibility of a strategy training clinical trial in a small group of adults with stroke-related cognitive impairments in inpatient rehabilitation, and to explore the impact of strategy training on disability. Non-randomized two-group intervention pilot study. Two inpatient rehabilitation units within an academic health centre. Individuals with a primary diagnosis of acute stroke, who were admitted to inpatient rehabilitation and demonstrated cognitive impairments were included. Individuals with severe aphasia; dementia; major depressive disorder, bipolar, or psychotic disorder; recent drug or alcohol abuse; and anticipated length of stay less than five days were excluded. Participants received strategy training or an attention control session in addition to usual rehabilitation care. Sessions in both groups were 30-40 minutes daily, five days per week, for the duration of inpatient rehabilitation. We assessed feasibility through participants' recruitment and retention; research intervention session number and duration; participants' comprehension and engagement; intervention fidelity; and participants' satisfaction. We assessed disability at study admission, inpatient rehabilitation discharge, 3 and 6 months using the Functional Independence Measure. Participants in both groups (5 per group) received the assigned intervention (>92% planned sessions; >94% fidelity) and completed follow-up testing. Strategy training participants in this small sample demonstrated significantly less disability at six months (M (SE) = 117 (3)) than attention control participants (M(SE) = 96 (14); t 8 = 7.87, P = 0.02). It is feasible and acceptable to administer both intervention protocols as an adjunct to acute inpatient rehabilitation, and strategy training shows promise for reducing disability.

Effectiveness of a 16 week gymnastics curriculum at developing movement competence in children.

PubMed

Rudd, James R; Barnett, Lisa M; Farrow, Damian; Berry, Jason; Borkoles, Erika; Polman, Remco

2017-02-01

Internationally, children's movement competence levels are low. This study's aim was to evaluate the effectiveness of a 16 week gymnastics curriculum on stability, locomotive and object control skills and general body coordination. It was hypothesised that the gymnastics intervention group would demonstrate significant improvements beyond a PE comparison group. This study used a non-randomised control design. The intervention and comparison groups were drawn from three primary schools. The study followed the transparent reporting of evaluations with nonrandomized designs (TREND) statement for reporting. A total of 333 children (51% girls, 41% intervention) with a mean age of 8.1 years (SD=1.1) participated. Intervention children (16 weeks×2h of gymnastics) were compared to children who received (16×2h) standard PE curriculum. Children's movement competence was assessed using the Test of Gross Motor Development-2, Stability Skills Assessment and the Körper-Koordinationstest für Kinder. Multilevel linear mixed models, accounting for variation at the class level and adjusted for age and sex, were used to assess intervention relative to comparison differences in all aspects of movement competence. Stability and object control skills showed a significant (p<0.05) intervention×time interaction effect. No difference was found in locomotor skills or general coordination. Gymnastics is effective at developing stability skills and object control skills without hindering the development of locomotor skills or general coordination. Accelerated learning of stability skills may support the development of more complex movement skills. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

The Role of Salivary Neuropeptides in Pediatrics: Potential Biomarkers for Integrated Therapies

PubMed Central

Gershan, Lynn A; Durham, Paul L; Skidmore, Jaci; Shimizu, Joshua; Cady, Ryan J; Sheng, Xiaoming; Maloney, Christopher G

2015-01-01

Introduction Objective measures of symptom response to integrated complementary approaches in pediatrics are evolving. The purpose of this study was to document the concentration range of salivary neuropeptides in healthy controls and in children with cancer, to explore correlations between serum and salivary measurements for Calcitonin Gene-Related Peptide (CGRP) and Vasoactive Intestinal Polypeptide (VIP), and to determine whether there is a change in these salivary neuropeptide levels in response to integrated mind-body therapies. Methods A non-randomized pragmatic study with three phases: Phase 1- Healthy Control Saliva-10 healthy controls provided saliva samples; Phase 2- Cancer Diagnosis Serum-Saliva- 16 mixed-type cancer patients provided blood and saliva samples; Phase 3- Acute Lymphocytic Leukemia (ALL) Saliva Intervention- 12 patients with ALL provided pre- and post-complementary intervention saliva samples. Interventions 20-minutes of structured touch or scripted relaxation breathing were administered to patients in Phase 3; Phase 1 and 2 patients did not receive this intervention. Outcome Measures cortisol, CGRP, VIP, State/Trait Anxiety Scale, visual analogue scale, vital signs. Results Salivary CGRP and VIP were similar for children in Phases 1 and 2. There was a correlation between serum and salivary VIP in the mixed cancer group, though not between serum and salivary CGRP. In Phase 3 children, following a complementary intervention, salivary CGRP, heart rate, and systolic blood pressure decreased. Discussion/Conclusions These data provide evidence of a decrease in sympathetic output after integrative/complementary therapy intervention in children with cancer. The study underscores the potential role of salivary neuropeptides as non-invasive biomarkers for integrated therapies in pediatrics. PMID:26388958

The Effect of Orem’s Self-Care Model on Fatigue in Patients With Multiple Sclerosis: A Single Blind Randomized Clinical Trial Study

PubMed Central

Afrasiabifar, Ardashir; Mehri, Zahra; Javad Sadat, Saied; Ghaffarian Shirazi, Hamid Reza

2016-01-01

Background Orem’s self-care model is a nursing model that was introduced with the purpose of improving the self-care of individuals, especially patients suffering from chronic diseases. Objectives To determining the effect of Orem’s self-care model on fatigue in multiple sclerosis patients. Patients and Methods This research involved a clinical trial. Sixty-three multiple sclerosis patients at the vice-chancellor in treatment affairs of Yasuj University of Medical Sciences were selected based on nonrandom sampling, but they were allocated to the two groups based on random allocation. In the intervention group, Orem’s model was applied during six sessions of 45 - 60 minutes in length, and the process continued for 1 month. The data were collected 1 week before and 7 weeks after the end of the intervention using the Orem’s self-care model-based assessment form and fatigue severity scale, the validity and reliability of which have been Results Before the intervention, 11.11% of the participants had a good knowledge of self-care. In addition, self-care willingness and skills were observed in 76.19% and 4.76% of participants, respectively. The mean difference in fatigue reduced significantly in the intervention group after the intervention (P < 0.05). After the intervention, a statistically significant difference was observed in the mean difference of fatigue between the two groups (P < 0.05). Conclusions Orem’s self-care model is significantly effective in reducing the fatigue of multiple sclerosis patients. PMID:27781119

Sexual and gender-based violence in areas of armed conflict: a systematic review of mental health and psychosocial support interventions

PubMed Central

2013-01-01

Background Sexual and other forms of gender-based violence are common in conflict settings and are known risk factors for mental health and psychosocial wellbeing. We present findings from a systematic review of the academic and grey literature focused on the effectiveness of mental health and psychosocial support interventions for populations exposed to sexual and other forms of gender-based violence in the context of armed conflicts. Methods We searched the Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, PubMed/ Medline, psycINFO, and PILOTS, as well as grey literature to search for evaluations of interventions, without date limitations. Results Out of 5,684 returned records 189 full text papers were assessed for eligibility. Seven studies met inclusion criteria: 1 non-randomized controlled study; 3 non-controlled pre- post-test designs; 1 retrospective cohort with a matched comparison group; and 2 case studies. Studies were conducted in West and Central Africa; Albania; UK and USA, included female participants, and focused on individual and group counseling; combined psychological, medical, social and economic interventions; and cognitive behavioral therapy (two single case studies). Conclusions The seven studies, while very limited, tentatively suggest beneficial effects of mental health and psychosocial interventions for this population, and show feasibility of evaluation and implementation of such interventions in real-life settings through partnerships with humanitarian organizations. Robust conclusions on the effectiveness of particular approaches are not possible on the basis of current evidence. More rigorous research is urgently needed. PMID:23915821

Impact of specialist home-based palliative care services in a tertiary oncology set up: a prospective non-randomized observational study.

PubMed

Dhiliwal, Sunil R; Muckaden, Maryann

2015-01-01

Home-based specialist palliative care services are developed to meet the needs of the patients in advanced stage of cancer at home with physical symptoms and distress. Specialist home care services are intended to improve symptom control and quality of life, enable patients to stay at home, and avoid unnecessary hospital admission. Total 690 new cases registered under home-based palliative care service in the year 2012 were prospectively studied to assess the impact of specialist home-based services using Edmonton symptom assessment scale (ESAS) and other parameters. Out of the 690 registered cases, 506 patients received home-based palliative care. 50.98% patients were cared for at home, 28.85% patients needed hospice referral and 20.15% patients needed brief period of hospitalization. All patients receiving specialist home care had good relief of physical symptoms (P < 0.005). 83.2% patients received out of hours care (OOH) through liaising with local general practitioners; 42.68% received home based bereavement care and 91.66% had good bereavement outcomes. Specialist home-based palliative care improved symptom control, health-related communication and psychosocial support. It promoted increased number of home-based death, appropriate and early hospice referral, and averted needless hospitalization. It improved bereavement outcomes, and caregiver satisfaction.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

PubMed

Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

2015-02-01

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

A newly developed tool for classifying study designs in systematic reviews of interventions and exposures showed substantial reliability and validity.

PubMed

Seo, Hyun-Ju; Kim, Soo Young; Lee, Yoon Jae; Jang, Bo-Hyoung; Park, Ji-Eun; Sheen, Seung-Soo; Hahn, Seo Kyung

2016-02-01

To develop a study Design Algorithm for Medical Literature on Intervention (DAMI) and test its interrater reliability, construct validity, and ease of use. We developed and then revised the DAMI to include detailed instructions. To test the DAMI's reliability, we used a purposive sample of 134 primary, mainly nonrandomized studies. We then compared the study designs as classified by the original authors and through the DAMI. Unweighted kappa statistics were computed to test interrater reliability and construct validity based on the level of agreement between the original and DAMI classifications. Assessment time was also recorded to evaluate ease of use. The DAMI includes 13 study designs, including experimental and observational studies of interventions and exposure. Both the interrater reliability (unweighted kappa = 0.67; 95% CI [0.64-0.75]) and construct validity (unweighted kappa = 0.63, 95% CI [0.52-0.67]) were substantial. Mean classification time using the DAMI was 4.08 ± 2.44 minutes (range, 0.51-10.92). The DAMI showed substantial interrater reliability and construct validity. Furthermore, given its ease of use, it could be used to accurately classify medical literature for systematic reviews of interventions although minimizing disagreement between authors of such reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of a train-the-trainer program for stable coronary artery disease management in community settings: A pilot study.

PubMed

Shen, Zhiyun; Jiang, Changying; Chen, Liqun

2018-02-01

To evaluate the feasibility and effectiveness of conducting a train-the-trainer (TTT) program for stable coronary artery disease (SCAD) management in community settings. The study involved two steps: (1) tutors trained community nurses as trainers and (2) the community nurses trained patients. 51 community nurses attended a 2-day TTT program and completed questionnaires assessing knowledge, self-efficacy, and satisfaction. By a feasibility and non-randomized control study, 120 SCAD patients were assigned either to intervention group (which received interventions from trained nurses) or control group (which received routine management). Pre- and post-intervention, patients' self-management behaviors and satisfaction were assessed to determine the program's overall impact. Community nurses' knowledge and self-efficacy improved (P<0.001), as did intervention group patients' self-management behaviors (P<0.001). The satisfaction of community nurses and patients was all very positive after training. The TTT program for SCAD management in community settings in China was generally feasible and effective, but many obstacles remain including patients' noncompliance, nurses' busy work schedules, and lack of policy supports. Finding ways to enhance the motivation of community nurses and patients with SCAD are important in implementing community-based TTT programs for SCAD management; further multicenter and randomized control trials are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

The effect of music on preprocedure anxiety in Hong Kong Chinese day patients.

PubMed

Lee, David; Henderson, Amanda; Shum, David

2004-03-01

To identify the effect of music on preprocedure anxiety levels of Hong Kong Chinese patients undergoing day procedures in a local community based hospital. Pre and post-test quasi experimental design with non-random assignment. A total of 113 participants were assigned to the control group or intervention group depending on the day of their procedure. Participants' anxiety levels were measured objectively by comparing their vital signs and subjectively by the Spielberger State Trait Anxiety Scale. Participants' physiological parameters (blood pressure, pulse and respiration) and State Trait Anxiety Scale were measured at two time periods. The control group undertook the usual relaxing activities provided in the waiting room compared with the intervention group who listened to music of their own choice in reclining chairs while waiting for the procedure. The physiological parameters for both the control and intervention groups dropped significantly during the waiting period, however, only the intervention group had a significant reduction in reported anxiety levels. These results suggest that providing self-selected music to day procedure patients in the preprocedure period assists in the reduction of physiological parameters and anxiety, yet, a relaxing environment can assist in the reduction of physiological parameters. The administration of self-selected music to day procedure patients in the preprocedure period can be effective in the reduction of physiological parameters and anxiety.

Impact of a Malaria-Control Project in Benin That Included the Integrated Management of Childhood Illness Strategy

PubMed Central

Onikpo, Faustin; Lama, Marcel; Osterholt, Dawn M.; Deming, Michael S.

2011-01-01

Objectives. To estimate the impact of the Integrated Management of Childhood Illness (IMCI) strategy on early-childhood mortality, we evaluated a malaria-control project in Benin that implemented IMCI and promoted insecticide-treated nets (ITNs). Methods. We conducted a before-and-after intervention study that included a nonrandomized comparison group. We used the preceding birth technique to measure early-childhood mortality (risk of dying before age 30 months), and we used health facility surveys and household surveys to measure process indicators. Results. Most process indicators improved in the area covered by the intervention. Notably, because ITNs were also promoted in the comparison area children's ITN use increased by about 20 percentage points in both areas. Regarding early-childhood mortality, the trend from baseline (1999–2001) to follow-up (2002–2004) for the intervention area (13.0% decrease; P < .001) was 14.1% (P < .001) lower than was the trend for the comparison area (1.3% increase; P = .46). Conclusions. Mortality decreased in the intervention area after IMCI and ITN promotion. ITN use increased similarly in both study areas, so the mortality impact of ITNs in the 2 areas might have canceled each other out. Thus, the mortality reduction could have been primarily attributable to IMCI's effect on health care quality and care-seeking. PMID:21566036

Evaluation of a Meditation Intervention to Reduce the Effects of Stressors Associated With Compassion Fatigue Among Nurses.

PubMed

Hevezi, Julie A

2016-12-01

This pilot study evaluated whether short (less than 10 minutes) structured meditations decrease compassion fatigue and improve compassion satisfaction in oncology nurses. A nonrandomized, pre-post intervention study. Participants used specific meditations designed to establish a sense of calm, relaxation, and self-compassion 5 days a week for 4 weeks. Meditations were provided on an audio-CD after brief individual instruction. The Professional Quality of Life Survey, Version 5, was administered pre and post intervention along with supplementary questions. Fifteen nurses participated in the study over a 6-month period in 2014. Paired t test revealed that the intervention demonstrated a statistically significant increase in Compassion Satisfaction scores (mean difference = -2.66, 95% confidence interval [CI] = [-4.98, -0.36], t[14] = -2.48, p = .027, d = 0.63) and decreases in Burnout (mean difference = 4.13, 95% CI = [1.66, 6.60], t[14] = 3.581, p = .003, d = 0.92) and Secondary Trauma (mean difference = 3.00, 95% CI = [0.40, 5.96], t[14] = 2.174, p = .047, d = 0.56) scores. All participants reported increased feelings of relaxation and well-being on supplemental questions. Even in this small sample, the practice of short breathing and meditation exercises was effective in improving nurse outcomes. A larger study is warranted including tracking sustained effects relative to maintaining a meditation practice. © The Author(s) 2015.

Designing an intervention to prevent suicide: PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial)

PubMed Central

Bruce, Martha L.; Pearson, Jane L.

1999-01-01

Suicide is a major public health problem with greatest risk in the very old. This paper describes an approach to reducing the risk of suicide by intervening on depression in elderly primary care patients. Depression is an appropriate target for an intervention as it is highly prevalent in primary care, is a strong risk factor for suicide, and is more often than not inadequately treated. PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) is a National institute of Mental Health (NIMH)-funded collaborative study that is testing this approach to suicide risk prevention in 18 primary care practices in the United States. PROSPECT'S intervention of “guideline management” introduces a health specialist into the primary care setting to help physicians provide “on-time, on-target” treatment and long-term management of late-life depression following structured clinical guidelines. The effectiveness of the intervention in reducing suicidal risk and depression is evaluated by following a representative sample of older patients identified using a 2-stage design. PMID:22033641

How Does Physical Activity Intervention Improve Self-Esteem and Self-Concept in Children and Adolescents? Evidence from a Meta-Analysis.

PubMed

Liu, Mingli; Wu, Lang; Ming, Qingsen

2015-01-01

To perform a systematic review and meta-analysis for the effects of physical activity intervention on self-esteem and self-concept in children and adolescents, and to identify moderator variables by meta-regression. A meta-analysis and meta-regression. Relevant studies were identified through a comprehensive search of electronic databases. Study inclusion criteria were: (1) intervention should be supervised physical activity, (2) reported sufficient data to estimate pooled effect sizes of physical activity intervention on self-esteem or self-concept, (3) participants' ages ranged from 3 to 20 years, and (4) a control or comparison group was included. For each study, study design, intervention design and participant characteristics were extracted. R software (version 3.1.3) and Stata (version 12.0) were used to synthesize effect sizes and perform moderation analyses for determining moderators. Twenty-five randomized controlled trial (RCT) studies and 13 non-randomized controlled trial (non-RCT) studies including a total of 2991 cases were identified. Significant positive effects were found in RCTs for intervention of physical activity alone on general self outcomes (Hedges' g = 0.29, 95% confidence interval [CI]: 0.14 to 0.45; p = 0.001), self-concept (Hedges' g = 0.49, 95%CI: 0.10 to 0.88, p = 0.014) and self-worth (Hedges' g = 0.31, 95%CI: 0.13 to 0.49, p = 0.005). There was no significant effect of intervention of physical activity alone on any outcomes in non-RCTs, as well as in studies with intervention of physical activity combined with other strategies. Meta-regression analysis revealed that higher treatment effects were associated with setting of intervention in RCTs (β = 0.31, 95%CI: 0.07 to 0.55, p = 0.013). Intervention of physical activity alone is associated with increased self-concept and self-worth in children and adolescents. And there is a stronger association with school-based and gymnasium-based intervention compared with other settings.

Impact of a primary care intervention on physician practice and patient and family behavior: keep ME Healthy---the Maine Youth Overweight Collaborative.

PubMed

Polacsek, Michele; Orr, Joan; Letourneau, Lisa; Rogers, Victoria; Holmberg, Robert; O'Rourke, Karen; Hannon, Cindy; Lombard, Kenneth A; Gortmaker, Steven L

2009-06-01

To evaluate the effect of a pediatric primary care-based intervention, on improved clinical decision support and family management of risk behaviors for childhood overweight. An experimental field trial was conducted with 12 intervention sites in urban and rural areas of Maine and nonrandomized control sites. Change was assessed by using clinical and parent measures from 9 intervention and 10 control sites before and during the Maine Youth Overweight Collaborative intervention. Longitudinal information was collected from chart audits of patients aged 5-18 years (n = 600), systematic samples of parents collected before (n = 346) and during (n = 386) the intervention in 12 sites, and systematic samples of parents in 9 intervention (n = 235) and 10 control (n = 304) sites collected during the intervention. Surveys of health care providers (n = 14 and 17) before and during the intervention were also collected. Teams worked over 18 months to implement improvements in clinical decision support, including tracking BMI percentiles, identification of overweight patients, appropriate laboratory tests, counseling of families and patients use of a behavioral screening tool, and other improvements following the chronic-care model targeting patients aged 5 to 18 and their families. Large changes occurred in clinical practice from before to during the Maine Youth Overweight Collaborative: increases in assessment of BMI (38%-94%), BMI percentile for age and gender (25%-89%), use of the 5-2-1-0 behavioral screening tool (0%-82%), and weight classification (19%-75%). Parent surveys indicated improvements in providers' behavior and rates of counseling. Intervention providers reported improvements in knowledge, attitudes, self-efficacy, and practice. The Maine Youth Overweight Collaborative intervention improved clinical decision support and family management of risk behaviors, indicating a promising primary care-based approach to address overweight risk among children and youth.

The psychenet public health intervention for anorexia nervosa: a pre-post-evaluation study in a female patient sample.

PubMed

Gumz, Antje; Weigel, Angelika; Wegscheider, Karl; Romer, Georg; Löwe, Bernd

2018-01-01

Aim This non-randomized pre-post-intervention study investigated the effect of a systemic public health intervention on the length of time between anorexia nervosa symptom onset and contact with the health care system as well as the initiation of treatment. Although systemic public health interventions have successfully been implemented in physical and mental health fields, their effect on the early treatment of patients with anorexia nervosa remains unclear. In total, 59 anorexia nervosa patients (mean age=21.5 years, SD=7.2) were recruited before a systemic public health intervention, and 18 patients (mean age=22.2 years, SD=8.9) were recruited afterwards. Using validated self-report measures and a semi-structured interview, the duration of untreated anorexia nervosa and the duration until first contact with the health care system were investigated. Findings At the beginning of the individual treatment initiation process, participants in both samples most frequently consulted their general practitioner or paediatrician about their eating disorder-related symptoms. Neither the mean duration of untreated anorexia nervosa, that is, the time between illness onset and the initiation of a recommended treatment, nor the duration until first contact with the health care system significantly decreased after the implementation of the systemic public health intervention. The mean duration of untreated anorexia nervosa was 36.5 months (SD=68.2) before the systemic public health intervention and 40.1 months (SD=89.4) after the implementation of the systemic public health intervention. The mean duration until first contact with the health care system was 25.0 months (SD=53.0) before the intervention and 32.8 months (SD=86.5) after the intervention. Primary care providers are crucial to the treatment initiation process and should be involved in future interventions to improve early detection and treatment commencement amongst patients with anorexia nervosa.

Offender and offense characteristics of a nonrandom sample of adolescent mass murderers.

PubMed

Meloy, J R; Hempel, A G; Mohandie, K; Shiva, A A; Gray, B T

2001-06-01

The authors conducted a descriptive, archival study of adolescent (< or =19 years of age) mass murderers-subjects who intentionally killed three or more victims in one event-to identify demographic, clinical, and forensic characteristics. A nonrandom sample of convenience of adolescent mass murderers was utilized. Thirty-four subjects, acting alone or in pairs, committed 27 mass murders between 1958 and 1999. The sample consisted of males with a median age of 17. A majority were described as "loners" and abused alcohol or drugs; almost half were bullied by others, preoccupied with violent fantasy, and violent by history. Although 23% had a documented psychiatric history, only 6% were judged to have been psychotic at the time of the mass murder. Depressive symptoms and historical antisocial behaviors were predominant. There was a precipitating event in most cases--usually a perceived failure in love or school--and most subjects made threatening statements regarding the mass murder to third parties. The majority of the sample clustered into three types: the family annihilator, the classroom avenger, and the criminal opportunist. The adolescent mass murderer is often predatorily rather than affectively violent and typically does not show any sudden or highly emotional warning signs. Although the act of mass murder is virtually impossible to predict because of its extremely low frequency, certain clinical and forensic findings can alert the clinician to the need for further, intensified primary care, including family, school, community, law enforcement, and mental health intervention.

Detecting Random, Partially Random, and Nonrandom Minnesota Multiphasic Personality Inventory-2 Protocols

ERIC Educational Resources Information Center

Pinsoneault, Terry B.

2007-01-01

The ability of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2; J. N. Butcher et al., 2001) validity scales to detect random, partially random, and nonrandom MMPI-2 protocols was investigated. Investigations included the Variable Response Inconsistency scale (VRIN), F, several potentially useful new F and VRIN subscales, and F-sub(b) - F…

Classroom-Based Narrative and Vocabulary Instruction: Results of an Early-Stage, Nonrandomized Comparison Study

ERIC Educational Resources Information Center

Gillam, Sandra Laing; Olszewski, Abbie; Fargo, Jamison; Gillam, Ronald B.

2014-01-01

Purpose: This nonrandomized feasibility study was designed to provide a preliminary assessment of the impact of a narrative and vocabulary instruction program provided by a speech-language pathologist (SLP) in a regular classroom setting. Method: Forty-three children attending 2 first-grade classrooms participated in the study. Children in each…

Non-random species loss in a forest herbaceous layer following nitrogen addition

Treesearch

Christopher A. ​Walter; Mary Beth Adams; Frank S. Gilliam; William T. Peterjohn

2017-01-01

Nitrogen (N) additions have decreased species richness (S) in hardwood forest herbaceous layers, yet the functional mechanisms for these decreases have not been explicitly evaluated.We tested two hypothesized mechanisms, random species loss (RSL) and non-random species loss (NRSL), in the hardwood forest herbaceous layer of a long-term, plot-scale...

Health behaviour change interventions for couples: A systematic review.

PubMed

Arden-Close, Emily; McGrath, Nuala

2017-05-01

Partners are a significant influence on individuals' health, and concordance in health behaviours increases over time in couples. Several theories suggest that couple-focused interventions for health behaviour change may therefore be more effective than individual interventions. A systematic review of health behaviour change interventions for couples was conducted. Systematic search methods identified randomized controlled trials (RCTs) and non-randomized interventions of health behaviour change for couples with at least one member at risk of a chronic physical illness, published from 1990-2014. We identified 14 studies, targeting the following health behaviours: cancer prevention (6), obesity (1), diet (2), smoking in pregnancy (2), physical activity (1) and multiple health behaviours (2). In four out of seven trials couple-focused interventions were more effective than usual care. Of four RCTs comparing a couple-focused intervention to an individual intervention, two found that the couple-focused intervention was more effective. The studies were heterogeneous, and included participants at risk of a variety of illnesses. In many cases the intervention was compared to usual care for an individual or an individual-focused intervention, which meant the impact of the couplebased content could not be isolated. Three arm studies could determine whether any added benefits of couple-focused interventions are due to adding the partner or specific content of couple-focused interventions. Statement of contribution What is already known on this subject? Health behaviours and health behaviour change are more often concordant across couples than between individuals in the general population. Couple-focused interventions for chronic conditions are more effective than individual interventions or usual care (Martire, Schulz, Helgeson, Small, & Saghafi, ). What does this study add? Identified studies targeted a variety of health behaviours, with few studies in any one area. Further assessment of the effectiveness of couple-focused versus individual interventions for those at risk is needed. Three-arm study designs are needed to determine benefits of targeting couples versus couple-focused intervention content. © 2017 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of the British Psychological Society.

Initial Feasibility and Validity of a Prospective Memory Training Program in a Substance Use Treatment Population

PubMed Central

Sweeney, Mary M.; Rass, Olga; Johnson, Patrick S.; Strain, Eric C.; Berry, Meredith S.; Vo, Hoa T.; Fishman, Marc J.; Munro, Cynthia A.; Rebok, George W.; Mintzer, Miriam Z.; Johnson, Matthew W.

2016-01-01

Individuals with substance use disorders have shown deficits in the ability to implement future intentions, called prospective memory. Deficits in prospective memory and working memory, a critical underlying component of prospective memory, likely contribute to substance use treatment failures. Thus, improvement of prospective memory and working memory in substance use patients is an innovative target for intervention. We sought to develop a feasible and valid prospective memory training program that incorporates working memory training and may serve as a useful adjunct to substance use disorder treatment. We administered a single session of the novel prospective memory and working memory training program to participants (n = 22; 13 male; 9 female) enrolled in outpatient substance use disorder treatment and correlated performance to existing measures of prospective memory and working memory. Generally accurate prospective memory performance in a single session suggests feasibility in a substance use treatment population. However, training difficulty should be increased to avoid ceiling effects across repeated sessions. Consistent with existing literature, we observed superior performance on event-based relative to time-based prospective memory tasks. Performance on the prospective memory and working memory training components correlated with validated assessments of prospective memory and working memory, respectively. Correlations between novel memory training program performance and established measures suggest that our training engages appropriate cognitive processes. Further, differential event- and time-based prospective memory task performance suggests internal validity of our training. These data support development of this intervention as an adjunctive therapy for substance use disorders. PMID:27690506

Initial feasibility and validity of a prospective memory training program in a substance use treatment population.

PubMed

Sweeney, Mary M; Rass, Olga; Johnson, Patrick S; Strain, Eric C; Berry, Meredith S; Vo, Hoa T; Fishman, Marc J; Munro, Cynthia A; Rebok, George W; Mintzer, Miriam Z; Johnson, Matthew W

2016-10-01

Individuals with substance use disorders have shown deficits in the ability to implement future intentions, called prospective memory. Deficits in prospective memory and working memory, a critical underlying component of prospective memory, likely contribute to substance use treatment failures. Thus, improvement of prospective memory and working memory in substance use patients is an innovative target for intervention. We sought to develop a feasible and valid prospective memory training program that incorporates working memory training and may serve as a useful adjunct to substance use disorder treatment. We administered a single session of the novel prospective memory and working memory training program to participants (n = 22; 13 men, 9 women) enrolled in outpatient substance use disorder treatment and correlated performance to existing measures of prospective memory and working memory. Generally accurate prospective memory performance in a single session suggests feasibility in a substance use treatment population. However, training difficulty should be increased to avoid ceiling effects across repeated sessions. Consistent with existing literature, we observed superior performance on event-based relative to time-based prospective memory tasks. Performance on the prospective memory and working memory training components correlated with validated assessments of prospective memory and working memory, respectively. Correlations between novel memory training program performance and established measures suggest that our training engages appropriate cognitive processes. Further, differential event- and time-based prospective memory task performance suggests internal validity of our training. These data support the development of this intervention as an adjunctive therapy for substance use disorders. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

PubMed

Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

2016-01-01

Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

The role of high-resolution endoscopy and narrow-band imaging in the evaluation of upper GI neoplasia in familial adenomatous polyposis.

PubMed

Lopez-Ceron, Maria; van den Broek, Frank J C; Mathus-Vliegen, Elisabeth M; Boparai, Karam S; van Eeden, Susanne; Fockens, Paul; Dekker, Evelien

2013-04-01

The Spigelman classification stratifies cancer risk in familial adenomatous polyposis (FAP) patients with duodenal adenomatosis. High-resolution endoscopy (HRE) and narrow-band imaging (NBI) may identify lesions at high risk. To compare HRE and NBI for the detection of duodenal and gastric polyps and to characterize duodenal adenomas harboring advanced histology with HRE and NBI. Prospective, nonrandomized, comparative study. Retrospective image evaluation study. Tertiary-care center. Thirty-seven FAP patients undergoing surveillance upper endoscopies. HRE endoscopy was followed by NBI. The number of gastric polyps and Spigelman staging were compared. Duodenal polyp images were systematically reviewed in a learning and validation phase. Number of gastric and duodenal polyps detected by HRE and NBI and prevalence of specific endoscopic features in duodenal adenomas with advanced histology. NBI did not identify additional gastric polyps but detected more duodenal adenomas in 16 examinations, resulting in upgrades of the Spigelman stage in 2 cases (4.4%). Pictures of 168 duodenal adenomas (44% advanced histology) were assessed. In the learning phase, 3 endoscopic features were associated with advanced histology: white color, enlarged villi, and size ≥1 cm. Only size ≥1 cm was confirmed in the validation phase (odds ratio 3.0; 95% confidence interval, 1.2-7.4). Nonrandomized study, scant number of high-grade dysplasia adenomas. Inspection with NBI did not lead to a clinically relevant upgrade in the Spigelman classification and did not improve the detection of gastric polyps in comparison with HRE. The only endoscopic feature that predicted advanced histology of a duodenal adenoma was size ≥1 cm. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Role of Internal Mammary Node Radiation as a Part of Modern Breast Cancer Radiation Therapy: A Systematic Review

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

Verma, Vivek; Vicini, Frank; Tendulkar, Rahul D.

Purpose: Despite data from multiple randomized trials, the role of internal mammary lymph node irradiation as a part of regional nodal irradiation (IMLN RT–RNI) remains unanswered. Recent noteworthy data and modern RT techniques might identify a subset of patients who will benefit from IMLN RT–RNI, lending insight into the balance between improved outcomes and acceptable toxicity. We evaluated the current role of IMLN RT–RNI by analyzing randomized, prospective, and retrospective data. Methods and Materials: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a review of the published data was performed using PubMed to evaluate publishedmore » studies from 1994 to 2015. The information evaluated included the number of patients, follow-up period, technical aspects of RT, and outcomes (clinical outcomes, complications/toxicity). Results: We included 16 studies (4 randomized, 4 nonrandomized, 7 retrospective, and 1 meta-analysis). Although older randomized trials failed to show differences in clinical outcomes or toxicity with IMLN RT–RNI, recent randomized data suggest the potential for improved outcomes, including overall survival, with IMLN RT–RNI. Furthermore, nonrandomized data have suggested a potential benefit for central tumors with IMLN RT–RNI. Although recent data have suggested a potential increase in pulmonary complications with IMLN RT–RNI with the use of advanced radiation techniques, toxicity rates remain low with limited cardiac toxicity data available. Conclusions: Increasing data from recent randomized trials support the use of IMLN RT–RNI. IMLN RT can be considered based on the inclusion of IMLN RT as a part of RNI in recent trials and the inclusion criteria from IMLN RT–RNI trials and for patients with central or medial tumors and axillary disease.« less

A nonrandomized comparison of the thulium laser and the CO2 laser in primary stapedotomy for otosclerosis.

PubMed

Kamalski, Digna M A; Vincent, Robert; Wegner, Inge; Bittermann, Arnold J N; Grolman, Wilko

2014-12-01

Comparing hearing results in patients with otosclerosis treated with laser-assisted stapedotomy using the 2-μm thulium laser or the CO2 laser. Prospective nonrandomized clinical study. In a tertiary referral center in France (Jean Causse Ear Clinic, Béziers), 208 primary stapedotomies were performed in 204 patients between March 2008 and November 2009. Sufficient follow-up data were available for 194 procedures. The fenestration in the footplate was made with the thulium laser in 98 procedures and with a flexible CO2 laser in 96 procedures. Preoperative and postoperative audiometric results were compared. Side effects, such as vertigo and tinnitus, were scored. Patients treated with the CO2 laser had better hearing outcome compared with those treated with the thulium laser at both 3 and 12 months of follow-up. At 3 months, the success of the surgery, defined as closure of the air-bone gap to within 10 dB, was 90.0% in the thulium group compared with 96.8% in the CO2 group. Bone conduction shift showed an overall deterioration of 1.6 dB (standard deviation, 6.9 dB) in the thulium group compared with an improvement of 1.3 dB (standard deviation, 4 dB) in the CO2 group. In the thulium group, there were four patients with sensorineural hearing loss (4.4%) and three with tinnitus (3.1%) compared with none in the CO2 group. Stapedotomy surgery performed with a fiber-delivered thulium laser resulted in a higher chance of inner ear damage measured by bone conduction shift compared with the use of a fiber-delivered CO2 laser. We advise not to use the thulium laser for stapedotomy.

Two-year controlled effectiveness trial of a school-based intervention to prevent obesity in Chilean children.

PubMed

Kain, Juliana; Leyton, Barbara; Cerda, Ricardo; Vio, Fernando; Uauy, Ricardo

2009-09-01

Obesity prevalence among Chilean children is 19.4%. The present study aimed to assess the effectiveness of a school-based obesity prevention programme. Non-randomized controlled study. The intervention included activities in nutrition and physical activity, fully applied the first year and partially in the second one. Primary outcomes were BMI Z-score (BMIZ) and obesity prevalence; secondary outcomes were waist circumference and triceps skinfold thickness. Time effects were assessed by changes in BMI-related variables by gender and period (ANOVA and Tukey test), while intervention effects were determined by comparing changes in (i) obesity prevalence by gender and period (PROC GENMOD) and (ii) BMIZ according gender, age and period (PROC MIXED). Primary schools in the Chilean cities of Casablanca (intervention group) and Quillota (control group). One thousand seven hundred and fifty-nine children from three schools (intervention group) and 671 from one school (control group). Over the two years, obesity prevalence and BMIZ declined significantly in the intervention group; from 17.0% to 12.3% and 14.1% to 10.3% in boys and girls, respectively, and from 0.62 to 0.53 and 0.64 to 0.58, respectively. In the control group, obesity remained stable at about 21% and 15%, while BMIZ increased significantly in the second year. BMIZ declined in both genders and all age categories in the intervention group during the first year (significant only in younger boys). No changes occurred during the summer, while during the second year, BMIZ increased in boys and girls from both groups (significant only in the younger control boys). Obesity declined significantly only in boys during the first year. Effectiveness was greater in the first school year and more evident in younger boys.

[Case management as a methodology for connecting the health and social care systems in Spain].

PubMed

Garcés, Jorge; Ródenas, Francisco

2015-10-01

The aim of this paper is to present the assessment of a case management project, implemented with chronic patients in Valencia, for the integration of health and social care. This project is linked with the 'Sustainable Socio-Health Model'. Health department 06 in Valencia. The target groups were chronic patients of 65 years and over. A non-randomized non-blinded comparative study with an intervention and control group. The intervention consisted in the creation of an interdisciplinary case management team, the use of a common portfolio of resources, and its application to a pilot sample with an intervention period of 6-9 months. Diseases (ICD-9), functional capacity, use of health and social resources, satisfaction, unit cost services. There was an increase in the combined use of health and social resources in the intervention group, which included social day centers (21.8% in the intervention group compared to 9.8% in the control group), in coordination with primary care (suggested as the only health resource in 55.4% of cases). There was a decrease in the number of medical visits in the intervention group (43.6% versus 74.5% in the control group). Increased patient satisfaction (55.5% in the intervention group compared to 29.4% in the control group) was observed. At least an extra 4.4% of patients were treated using hospital resources without increasing costs. Case management using a common unique portfolio of health and social resources can improve the coordination of resources, increases patient satisfaction and increases the capacity of using of hospital resources. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention

PubMed Central

Zoellner, Jamie M.; Porter, Kathleen J.; Chen, Yvonnes; Hedrick, Valisa E.; You, Wen; Hickman, Maja; Estabrooks, Paul A.

2017-01-01

Objective Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Design Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Main Outcome Measures Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. Results TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13–20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6–38%) and behaviour (average 30%, range 6–55%) were significant. Conclusion Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases. PMID:28165771

Breast Cancer–Related Lymphedema: Comparing Direct Costs of a Prospective Surveillance Model and a Traditional Model of Care

PubMed Central

Pfalzer, Lucinda A.; Springer, Barbara; Levy, Ellen; McGarvey, Charles L.; Danoff, Jerome V.; Gerber, Lynn H.; Soballe, Peter W.

2012-01-01

Secondary prevention involves monitoring and screening to prevent negative sequelae from chronic diseases such as cancer. Breast cancer treatment sequelae, such as lymphedema, may occur early or late and often negatively affect function. Secondary prevention through prospective physical therapy surveillance aids in early identification and treatment of breast cancer–related lymphedema (BCRL). Early intervention may reduce the need for intensive rehabilitation and may be cost saving. This perspective article compares a prospective surveillance model with a traditional model of impairment-based care and examines direct treatment costs associated with each program. Intervention and supply costs were estimated based on the Medicare 2009 physician fee schedule for 2 groups: (1) a prospective surveillance model group (PSM group) and (2) a traditional model group (TM group). The PSM group comprised all women with breast cancer who were receiving interval prospective surveillance, assuming that one third would develop early-stage BCRL. The prospective surveillance model includes the cost of screening all women plus the cost of intervention for early-stage BCRL. The TM group comprised women referred for BCRL treatment using a traditional model of referral based on late-stage lymphedema. The traditional model cost includes the direct cost of treating patients with advanced-stage lymphedema. The cost to manage early-stage BCRL per patient per year using a prospective surveillance model is $636.19. The cost to manage late-stage BCRL per patient per year using a traditional model is $3,124.92. The prospective surveillance model is emerging as the standard of care in breast cancer treatment and is a potential cost-saving mechanism for BCRL treatment. Further analysis of indirect costs and utility is necessary to assess cost-effectiveness. A shift in the paradigm of physical therapy toward a prospective surveillance model is warranted. PMID:21921254

Comprehensive long-term management program for asthma: effect on outcomes in adult African-Americans.

PubMed

Kelso, T M; Abou-Shala, N; Heilker, G M; Arheart, K L; Portner, T S; Self, T H

1996-06-01

To determine if a comprehensive long-term management program, emphasizing inhaled corticosteroids and patient education, would improve outcomes in adult African-American asthmatics a nonrandomized control trial with a 2-year intervention was performed in a university-based clinic. Inclusion criteria consisted of (> or = 5) emergency department (ED) visits or hospitalizations (> or = 2) during the previous 2 years. Intervention patients were volunteers; a comparable control group was identified via chart review at hospitals within the same area and time period as the intervention patients. Individualized doses of beclomethasone with a spacer, inhaled albuterol "as needed," and crisis prednisone were the primary therapies. Environmental control, peak flow monitoring, and a partnership with the patient were emphasized. Detailed patient education was an integral part of management. Control patients received usual care from local physicians. ED visits and hospitalizations for 2 years before and 2 years during the intervention period were compared. Quality of life (QOL) measurements were made at baseline and every 6 months in the intervention group. Study group (n = 21) had a significant reduction in ED visits (2.3 +/- 0.2 pre-intervention versus 0.6 +/- 0.2 post-intervention; P = 0.0001). Control group (n = 18) did not have a significant change in ED visits during the 2-year post-intervention period (2.6 +/- 0.2 pre-intervention versus 2.0 +/- 0.2 post-intervention; P = 0.11). Both groups had significant reductions in hospitalizations, but the study group had a greater reduction. Sixty-two percent of study patients had complete elimination of ED visits and hospitalizations, whereas no control patients had total elimination of the need for institutional acute care. QOL in the study patients revealed significant improvements for most parameters. A comprehensive long-term management program emphasizing inhaled corticosteroids combined with other state-of-the-art management, including intensive patient education, improves outcomes in adult African-American asthmatics.

Effects of Mindfulness-Based Interventions in High School and College Athletes for Reducing Stress and Injury, and Improving Quality of Life.

PubMed

Petterson, Haley; Olson, Bernadette L

2017-11-01

Clinical Scenario: Student athletes experience a variety of stressors from school and social activities, as well as the additional demands of sport participation. Mindfulness-based interventions can help increase mental awareness and acceptance, as well as mitigate negative thoughts and emotions. The use of mindfulness-based interventions may be beneficial for reducing thoughts of stress, injury reduction, and improving overall wellbeing. Does the use of mindfulness-based interventions for student-athletes aged 13-24 years reduce stress and injury as well as improve overall quality of life? The literature was searched for studies that investigated the use of mindfulness-based strategies for student-athletes specifically for reducing stress and injury and/or improving quality of life. The literature search returned 8 possible studies related to the clinical question and 3 studies met the inclusion criteria (1 randomized control trial, 2 nonrandomized control cohort studies). All 3 included studies demonstrated overall improved levels of mindfulness among student-athletes after the use of a mindfulness-based intervention. Mindfulness-based interventions had positive effects for reducing negative thoughts and levels of perceived stress. The number of injury occurrences were found to decrease following the integration of a mindfulness-based intervention within an athletic population. Clinical Bottom Line: There is sufficient evidence supporting the use of mindfulness-based interventions with student-athletes for increasing mindfulness, managing negative emotions and perceived stress, as well as improving overall well-being. There is also current literature that advocates the use of mindfulness-based interventions for reducing injury, but further research is needed for support. Strength of Recommendation: Grade B evidence exists to support that the use of mindfulness-based interventions for student-athletes will reduce stress and improve overall well-being as well as support the possibility that if a student-athlete is more mindful, it may help decrease risk of injury incurred if the student-athlete is under mental stress.

Identifying Baseline Covariates for Use in Propensity Scores: A Novel Approach Illustrated for a Nonrandomized Study of Recovery High Schools

ERIC Educational Resources Information Center

Tanner-Smith, Emily E.; Lipsey, Mark W.

2014-01-01

There are many situations where random assignment of participants to treatment and comparison conditions may be unethical or impractical. This article provides an overview of propensity score techniques that can be used for estimating treatment effects in nonrandomized quasi-experimental studies. After reviewing the logic of propensity score…

Cross-Sectional and Panel Data Analyses of an Incompletely Observed Variable Derived from the Nonrandomized Method for Surveying Sensitive Questions

ERIC Educational Resources Information Center

Yamaguchi, Kazuo

2016-01-01

This article describes (1) the survey methodological and statistical characteristics of the nonrandomized method for surveying sensitive questions for both cross-sectional and panel survey data and (2) the way to use the incompletely observed variable obtained from this survey method in logistic regression and in loglinear and log-multiplicative…

A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis

PubMed Central

Chao, Ming; Wu, Hao; Jin, Kai; Li, Bin; Wu, Jianjun; Zhang, Guangqiang; Yang, Gong; Hu, Xun

2016-01-01

Study design: Previous works suggested that neutralizing intratumoral lactic acidosis combined with glucose deprivation may deliver an effective approach to control tumor. We did a pilot clinical investigation, including a nonrandomized (57 patients with large HCC) and a randomized controlled (20 patients with large HCC) studies. Methods: The patients were treated with transarterial chemoembolization (TACE) with or without bicarbonate local infusion into tumor. Results: In the nonrandomized controlled study, geometric mean of viable tumor residues (VTR) in TACE with bicarbonate was 6.4-fold lower than that in TACE without bicarbonate (7.1% [95% CI: 4.6%–10.9%] vs 45.6% [28.9%–72.0%]; p<0.0001). This difference was recapitulated by a subsequent randomized controlled study. TACE combined with bicarbonate yielded a 100% objective response rate (ORR), whereas the ORR treated with TACE alone was 44.4% (nonrandomized) and 63.6% (randomized). The survival data suggested that bicarbonate may bring survival benefit. Conclusion: Bicarbonate markedly enhances the anticancer activity of TACE. Clinical trail registration: ChiCTR-IOR-14005319. DOI: http://dx.doi.org/10.7554/eLife.15691.001 PMID:27481188

Effective Size of Nonrandom Mating Populations

PubMed Central

Caballero, A.; Hill, W. G.

1992-01-01

Nonrandom mating whereby parents are related is expected to cause a reduction in effective population size because their gene frequencies are correlated and this will increase the genetic drift. The published equation for the variance effective size, N(e), which includes the possibility of nonrandom mating, does not take into account such a correlation, however. Further, previous equations to predict effective sizes in populations with partial sib mating are shown to be different, but also incorrect. In this paper, a corrected form of these equations is derived and checked by stochastic simulation. For the case of stable census number, N, and equal progeny distributions for each sex, the equation is & where S(k)(2) is the variance of family size and α is the departure from Hardy-Weinberg proportions. For a Poisson distribution of family size (S(k)(2) = 2), it reduces to N(e) = N/(1 + α), as when inbreeding is due to selfing. When nonrandom mating occurs because there is a specified system of partial inbreeding every generation, α can be substituted by Wright's F(IS) statistic, to give the effective size as a function of the proportion of inbred mates. PMID:1582565

The Effect of Video-Based Approach on Prospective Teachers' Ability to Analyze Mathematics Teaching

ERIC Educational Resources Information Center

Alsawaie, Othman N.; Alghazo, Iman M.

2010-01-01

This is an intervention study that explored the effect of using video lesson analysis methodology (VLAM) on the ability of prospective middle/high school mathematics teachers to analyze mathematics teaching. The sample of the study consisted of 26 female prospective mathematics teachers enrolled in a methods course at the United Arab Emirates…

Strategy Ranges: Describing Change in Prospective Elementary Teachers' Approaches to Mental Computation of Sums and Differences

ERIC Educational Resources Information Center

Whitacre, Ian

2015-01-01

This study investigated the sets of mental computation strategies used by prospective elementary teachers to compute sums and differences of whole numbers. In the context of an intervention designed to improve the number sense of prospective elementary teachers, participants were interviewed pre/post, and their mental computation strategies were…

Somatic experiencing treatment with social service workers following Hurricanes Katrina and Rita.

PubMed

Leitch, M Laurie; Vanslyke, Jan; Allen, Marisa

2009-01-01

In a disaster, social service workers are often survivors themselves.This study examines whether somatic intervention using a brief (one to two session) stabilization model now called the Trauma Resiliency Model (TRM), which uses the skills of Somatic Experiencing (SE), can reduce the postdisaster symptoms of social service workers involved in postdisaster service delivery.The study was implemented with a nonrandom sample of 142 social service workers who were survivors of Hurricanes Katrina and Rita in New Orleans and Baton Rouge, Louisiana, two to three months after the disasters. Ninety-one participants received SE/TRM and were compared with a matched comparison group of 51 participants through the use of propensity score matching. All participants first received group psychoeducation. Results support the benefits of the brief intervention inspired by SE. The treatment group showed statistically significant gains in resiliency indicators and decreases in posttraumatic stress disorder symptoms. Although psychological symptoms increased in both groups at the three to four month follow-up, the treatment group's psychological symptoms were statistically lower than those of the comparison group.

Towards a parsimonious program theory of return to work intervention.

PubMed

Claudi Jensen, Anne Grete

2013-01-01

Presentation of a salutogenic theory of return to work (RTW). The study group include 118 unskilled Danish public employees and privately employed house-cleaners on sick leave due to musculoskeletal and/or common mental illnesses. Theory of RTW is discussed from a theoretical and empirical viewpoint, using baseline-data from an intervention study in a longitudinal, non-randomized study design with follow-up after one year. High work ability, strong social support from colleagues and over-commitment are the most important prognostic factors for RTW. An active coping style, high self-efficacy and Sense of Coherence (SOC) are found to increase RTW and high hostility and over-commitment to decrease RTW. Besides health elements in work ability are SOC, self-efficacy, social support and physical activity. Work ability and active coping mediate positive associations between RTW and health, and a negative association with stress. Work ability seems to express the intention to work decisive for RTW, reflecting the interpretation of the work/health situation based on comprehensibility, meaningfulness and manageability. It is influenced by the personal view of life, attitudes and interaction with the workplace. An ecological theory, integrating health promotion is proposed. A later paper will present the intervention study and further validation of the theory.

Best practices for using natural experiments to evaluate retail food and beverage policies and interventions.

PubMed

Taillie, Lindsey Smith; Grummon, Anna H; Fleischhacker, Sheila; Grigsby-Toussaint, Diana S; Leone, Lucia; Caspi, Caitlin Eicher

2017-12-01

Policy and programmatic change in the food retail setting, including excise taxes on beverages with added-caloric sweeteners, new supermarkets in food deserts, and voluntary corporate pledges, often require the use of natural experimental evaluation for impact evaluation when randomized controlled trials are not possible. Although natural experimental studies in the food retail setting provide important opportunities to test how nonrandomized interventions affect behavioral and health outcomes, researchers face several key challenges to maintaining strong internal and external validity when conducting these studies. Broadly, these challenges include 1) study design and analysis; 2) selection of participants, selection of measures, and obtainment of data; and 3) real-world considerations. This article addresses these challenges and different approaches to meeting them. Case studies are used to illustrate these approaches and to highlight advantages and disadvantages of each approach. If the trade-offs required to address these challenges are carefully considered, thoughtful natural experimental evaluations can minimize bias and provide critical information about the impacts of food retail interventions to a variety of stakeholders, including the affected population, policymakers, and food retailers. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Periodontal therapy for pregnant women and cases of low birthweight: an intervention study.

PubMed

Cruz, Simone S; Costa, Maria da Conceição N; Gomes-Filho, Isaac S; Barreto, Maurício L; dos Santos, Carlos Antônio S T; Martins, Angela Guimarães; Passos, Johelle de S; de Freitas, Camila Oliveira T; Sampaio, Fábio P; Cerqueira, Eneida de M M

2010-02-01

Over the past decade, strong evidence for an association between maternal periodontitis and low birthweight has started to appear. However, few intervention studies have been proposed for investigating this hypothesis. The aim of this study was to evaluate whether periodontal therapy among pregnant women would reduce the incidence of low birthweight. A nonrandomized intervention study was performed, with two control groups. The sample comprised 339 pregnant women: 141 in the experimental group (treated for periodontitis), 145 in control group 1 (without periodontitis) and 53 in control group 2 (with untreated periodontitis). The experimental group received periodontal treatment throughout pregnancy, whereas control group 1 was only monitored over the same period. After delivery, birthweight information on the newborns was obtained. The analysis procedures consisted of stratified analysis followed by logistic regression. The frequency of low birthweight among the women with treated periodontitis was 9.22%, while it was 13.10% in the group without periodontal disease. However, the difference was not statistically significant (RR 0.72; 95% CI 0.36-1.45). The occurrence of this outcome in the group with untreated periodontitis (24.53%) was greater than in the other two groups. This suggests that periodontal therapy is a protective factor for birthweight.

Effectiveness of universal school-based mental health awareness programs among youth in the US: a systematic review

PubMed Central

2016-01-01

BACKGROUND Stigmatizing attitudes toward mental illness and low mental health literacy have been found to be barriers to seeking help for mental health related issues in adolescents. Prior research has found that it is possible to improve these outcomes using school-based mental health interventions. The purpose of this study was to review empirical literature pertaining to universal interventions addressing mental health among students enrolled in US K-12 schools, especially related to health disparities in vulnerable populations. METHODS PsycINFO, Cochrane Library, PUBMED, and reference lists of relevant articles were searched for K-12 school-based mental health awareness interventions in the US. Universal studies that measured knowledge, attitudes, and/or help-seeking pertinent to mental health were included. RESULTS A total of 15 studies were selected to be part of the review. There were 7 pretest/posttest case series, 5 non-randomized experimental trial, 1 Solomon 4-groups, and 2 randomized controlled trial designs (RCT). Nine studies measuring knowledge, 8 studies measuring attitudes, and 4 studies measuring help-seeking, indicated statistically significant improvement. CONCLUSIONS Although results of all studies indicated some level of improvement, more research on implementation of universal school-based mental health awareness programs is needed using RCT study designs, and long-term follow up implementation. PMID:27866385

A systematic review of implementation strategies to deliver guidelines on obstetric care practice in low- and middle-income countries.

PubMed

Imamura, Mari; Kanguru, Lovney; Penfold, Suzanne; Stokes, Tim; Camosso-Stefinovic, Janette; Shaw, Beth; Hussein, Julia

2017-01-01

Healthcare measures to prevent maternal deaths are well known. However, effective implementation of this knowledge to change practice remains a challenge. To assess whether strategies to promote the use of guidelines can improve obstetric practices in low- and middle-income countries (LMICs). Electronic databases were searched up to February 7, 2014, using relevant terms for implementation strategies (e.g. "audit," "education," "reminder"), and maternal mortality. Randomized and non-randomized studies of implementation strategies targeting healthcare professionals within the formal health services in LMICs were included. Cochrane methodological guidance was followed. Because of heterogeneity in the interventions, a narrative synthesis was completed. Nine studies met the inclusion criteria. Moderate-to-low-quality evidence was found to show improvement in the areas of doctor-patient communication (one study), analgesic provision (one study), the management of emergencies (two studies) and maternal and late neonatal mortality (one study each). Intervention effects were not consistent across studies. Implementation strategies targeting health professionals could lead to improvement in obstetric care in LMICs. Future research should explore what feature of an intervention is effective in one context and how this could be translated into another context. CRD42014010310. © 2016 International Federation of Gynecology and Obstetrics.

The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting

PubMed Central

Bazarko, Dawn; Cate, Rebecca A.; Azocar, Francisca; Kreitzer, Mary Jo

2013-01-01

This study implemented an innovative new model of delivering a Mindfulness-Based Stress Reduction (MBSR) program that replaces six of the eight traditional in-person sessions with group telephonic sessions (tMBSR) and measured the program's impact on the health and well-being of nurses employed within a large health care organization. As part of a nonrandomized pre–post intervention study, 36 nurses completed measures of health, stress, burnout, self-compassion, serenity, and empathy at three points in time. Between baseline (Time 1) and the end of the 8-week tMBSR intervention (Time 2), participants showed improvement in general health, t(37) = 2.8, p < .01, decreased stress, t(37) = 6.8, p < .001, decreased work burnout, t(37) = 4.0, p < .001, and improvement in several other areas. Improvements were sustained 4 months later (Time 3), and individuals who continued their MBSR practice after the program demonstrated better outcomes than those that did not. Findings suggest that the tMBSR program can be a low cost, feasible, and scalable intervention that shows positive impact on health and well-being, and could allow MBSR to be delivered to employees who are otherwise unable to access traditional, on-site programs. PMID:23667348

Centre-based day care for children younger than five years of age in low- and middle-income countries.

PubMed

Brown, Taylor W; van Urk, Felix C; Waller, Rebecca; Mayo-Wilson, Evan

2014-09-25

Because of poverty, children and families in low- and middle-income countries often face significant impediments to health and well-being. Centre-based day care services may influence the development of children and the economic situation of parents by providing good quality early childhood care and by freeing parents to participate in the labour force. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development, health and well-being of children and families in low- and middle-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, ERIC and 16 other sources, including several World Health Organization (WHO) regional databases. We also searched two trials registers, websites of government and non-government agencies and reference lists of relevant studies. We included randomised and quasi-randomised controlled trials and prospective non-randomised studies with contemporaneous control groups and assessments both before and after intervention. We considered non-randomised controlled trials, as centre-based care in low- and middle-income countries is unlikely to be studied using randomised controlled trials (Higgins 2011). We included the following outcomes: child intellectual development, child psychosocial development, maternal and family outcomes and incidence of infectious diseases. Two review authors independently assessed risk of bias and extracted data from the single included study. Only one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review. The single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.

Women, Co-occurring Disorders, and Violence Study: evaluation design and study population.

PubMed

McHugo, G J; Kammerer, N; Jackson, E W; Markoff, L S; Gatz, M; Larson, M J; Mazelis, R; Hennigan, K

2005-03-01

The Women, Co-occurring Disorders, and Violence Study (WCDVS) was a multi-site cooperative study to evaluate new service models for women with co-occurring mental health and substance use disorders and a history of physical and/or sexual abuse. Despite common features in the service interventions and evaluation procedures, diversity across the nine sites plus differences introduced by non-random assignment led to numerous methodological challenges. This article describes the design, measurement, and analysis decisions behind the WCDVS and lays the foundation for understanding participant-level outcomes and service costs. This article also describes the study population, as recruited and following attrition at the 6-month follow-up, in order to address the threat of selection bias to inferences drawn from this multi-site study.

Greater physician involvement improves coding outcomes in endobronchial ultrasound-guided transbronchial needle aspiration procedures.

PubMed

Pillai, Anilkumar; Medford, Andrew R L

2013-01-01

Correct coding is essential for accurate reimbursement for clinical activity. Published data confirm that significant aberrations in coding occur, leading to considerable financial inaccuracies especially in interventional procedures such as endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Previous data reported a 15% coding error for EBUS-TBNA in a U.K. service. We hypothesised that greater physician involvement with coders would reduce EBUS-TBNA coding errors and financial disparity. The study was done as a prospective cohort study in the tertiary EBUS-TBNA service in Bristol. 165 consecutive patients between October 2009 and March 2012 underwent EBUS-TBNA for evaluation of unexplained mediastinal adenopathy on computed tomography. The chief coder was prospectively electronically informed of all procedures and cross-checked on a prospective database and by Trust Informatics. Cost and coding analysis was performed using the 2010-2011 tariffs. All 165 procedures (100%) were coded correctly as verified by Trust Informatics. This compares favourably with the 14.4% coding inaccuracy rate for EBUS-TBNA in a previous U.K. prospective cohort study [odds ratio 201.1 (1.1-357.5), p = 0.006]. Projected income loss was GBP 40,000 per year in the previous study, compared to a GBP 492,195 income here with no coding-attributable loss in revenue. Greater physician engagement with coders prevents coding errors and financial losses which can be significant especially in interventional specialties. The intervention can be as cheap, quick and simple as a prospective email to the coding team with cross-checks by Trust Informatics and against a procedural database. We suggest that all specialties should engage more with their coders using such a simple intervention to prevent revenue losses. Copyright © 2013 S. Karger AG, Basel.

Effectiveness of Structured Education in Reduction of Postpartum Depression Scores: A Quasi-Experimental Study.

PubMed

Top, Ekin Dila; Karaçam, Zekiye

2016-06-01

The aim of this study was to evaluate effectiveness of structured education in reduction of postpartum depression scores among women. This was a quasi-experimental study with a pre-post tests and a control group. Non-random sampling was used and the study included a total of 103 Turkish women, 52 of whom were in the intervention group and 51 were in the control group. The women in the intervention group were offered structured education for postpartum depression and given structured education material. Effectiveness of the education given was evaluated by comparing scores for Edinburg Postpartum Depression Scale obtained before and after delivery between the intervention and the control groups. Before education, median score (8.0±4.8) for Edinburg Postpartum Depression Scale of the intervention group were significantly higher the than the control group (6.0±6.0, p=0.010), but the groups were statistically similar in terms of having depression (intervention: 17.3%, control: 11.8%, p=0.425). After education, the median score for Edinburg Postpartum Depression Scale and the ratio of the women having depression in the intervention group were significantly lower than in the control group (respectively intervention: 4.0±3.0, control: 10.0±4.0, p=0.000; intervention: 7.7%, control: 25.5%, p=0.015). Besides, the median score (8.0±4.8) of the intervention group before education were significantly higher than the score (4.0±3.0) obtained after education (p=0.000), while the median score (6.0±6.0) of the control group before education were lower than the score (10.0±4.0) obtained after education (p=0.000). This study revealed that structured education offered to women by nurses was effective in reducing the postpartum depression scores and the numbers of women having depression. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis

PubMed Central

2012-01-01

Background Previous studies have shown the beneficial effects of aerobic exercise in chronic stroke. Most motor and functional recovery occurs in the first months after stroke. Improving cardiovascular capacity may have potential to precipitate recovery during early stroke rehabilitation. Currently, little is known about the effects of early cardiovascular exercise in stroke survivors. The aim of this systematic review was to evaluate the effectiveness of cardiovascular exercise early after stroke. Methods A systematic literature search was performed. For this review, randomized and non-randomized prospective controlled cohort studies using a cardiovascular, cardiopulmonary or aerobic training intervention starting within 6 months post stroke were considered. The PEDro scale was used to detect risk of bias in individual studies. Inter-rater agreement was calculated (kappa). Meta-analysis was performed using a random-effects model. Results A total of 11 trials were identified for inclusion. Inter-rater agreement was considered to be “very good” (Kappa: 0.81, Standard Error: 0.06, CI95%: 0.70–0.92), and the methodological quality was “good” (7 studies) to “fair” (4 studies). Peak oxygen uptake data were available for 155 participants. Pooled analysis yielded homogenous effects favouring the intervention group (standardised mean difference (SMD) = 0.83, CI95% = 0.50–1.16, Z = 4.93, P < 0.01). Walking endurance assessed with the 6 Minute Walk Test comprised 278 participants. Pooled analysis revealed homogenous effects favouring the cardiovascular training intervention group (SMD = 0.69, CI95% = 0.45–0.94, Z = 5.58, P < 0.01). Gait speed, measured in 243 participants, did not show significant results (SMD = 0.51, CI95% = −0.25–1.26, Z = 1.31, P = 0.19) in favour of early cardiovascular exercise. Conclusion This meta-analysis shows that stroke survivors may benefit from cardiovascular exercise during sub-acute stages to improve peak oxygen uptake and walking distance. Thus, cardiovascular exercise should be considered in sub-acute stroke rehabilitation. However, concepts to influence and evaluate aerobic capacity in severely affected individuals with sub-acute stroke, as well as in the very early period after stroke, are lacking. Further research is needed to develop appropriate methods for cardiovascular rehabilitation early after stroke and to evaluate long-term effects of cardiovascular exercise on aerobic capacity, physical functioning, and quality-of-life. PMID:22727172

Effects of ignition location models on the burn patterns of simulated wildfires

USGS Publications Warehouse

Bar-Massada, A.; Syphard, A.D.; Hawbaker, T.J.; Stewart, S.I.; Radeloff, V.C.

2011-01-01

Fire simulation studies that use models such as FARSITE often assume that ignition locations are distributed randomly, because spatially explicit information about actual ignition locations are difficult to obtain. However, many studies show that the spatial distribution of ignition locations, whether human-caused or natural, is non-random. Thus, predictions from fire simulations based on random ignitions may be unrealistic. However, the extent to which the assumption of ignition location affects the predictions of fire simulation models has never been systematically explored. Our goal was to assess the difference in fire simulations that are based on random versus non-random ignition location patterns. We conducted four sets of 6000 FARSITE simulations for the Santa Monica Mountains in California to quantify the influence of random and non-random ignition locations and normal and extreme weather conditions on fire size distributions and spatial patterns of burn probability. Under extreme weather conditions, fires were significantly larger for non-random ignitions compared to random ignitions (mean area of 344.5 ha and 230.1 ha, respectively), but burn probability maps were highly correlated (r = 0.83). Under normal weather, random ignitions produced significantly larger fires than non-random ignitions (17.5 ha and 13.3 ha, respectively), and the spatial correlations between burn probability maps were not high (r = 0.54), though the difference in the average burn probability was small. The results of the study suggest that the location of ignitions used in fire simulation models may substantially influence the spatial predictions of fire spread patterns. However, the spatial bias introduced by using a random ignition location model may be minimized if the fire simulations are conducted under extreme weather conditions when fire spread is greatest. ?? 2010 Elsevier Ltd.

Effects of a post-deworming health hygiene education intervention on absenteeism in school-age children of the Peruvian Amazon.

PubMed

Thériault, François L; Maheu-Giroux, Mathieu; Blouin, Brittany; Casapía, Martin; Gyorkos, Theresa W

2014-08-01

Soil-transmitted helminth (STH) infections are a leading cause of disability and disease burden in school-age children of worm-endemic regions. Their effect on school absenteeism, however, remains unclear. The World Health Organization currently recommends delivering mass deworming and health hygiene education through school-based programs, in an effort to control STH-related morbidity. In this cluster-RCT, the impact of a health hygiene education intervention on absenteeism was measured. From April to June 2010, all Grade 5 students at 18 schools in a worm-endemic region of the Peruvian Amazon were dewormed. Immediately following deworming, nine schools were randomly assigned to the intervention arm of the trial using a matched-pair design. The Grade 5 students attending intervention schools (N = 517) received four months of health hygiene education aimed at increasing knowledge of STH prevention. Grade 5 students from the other nine schools (N = 571) served as controls. Absenteeism was measured daily through teachers' attendance logs. After four months of follow-up, overall absenteeism rates at intervention and control schools were not statistically significantly different. However, post-trial non-randomized analyses have shown that students with moderate-to-heavy Ascaris infections and light hookworm infections four months after deworming had, respectively, missed 2.4% (95% CI: 0.1%, 4.7%) and 4.6% (95% CI: 1.9%, 7.4%) more schooldays during the follow-up period than their uninfected counterparts. These results provide empirical evidence of a direct effect of STH infections on absenteeism in school-age children.

Effects of a Post-Deworming Health Hygiene Education Intervention on Absenteeism in School-Age Children of the Peruvian Amazon

PubMed Central

Thériault, François L.; Maheu-Giroux, Mathieu; Blouin, Brittany; Casapía, Martin; Gyorkos, Theresa W.

2014-01-01

Soil-transmitted helminth (STH) infections are a leading cause of disability and disease burden in school-age children of worm-endemic regions. Their effect on school absenteeism, however, remains unclear. The World Health Organization currently recommends delivering mass deworming and health hygiene education through school-based programs, in an effort to control STH-related morbidity. In this cluster-RCT, the impact of a health hygiene education intervention on absenteeism was measured. From April to June 2010, all Grade 5 students at 18 schools in a worm-endemic region of the Peruvian Amazon were dewormed. Immediately following deworming, nine schools were randomly assigned to the intervention arm of the trial using a matched-pair design. The Grade 5 students attending intervention schools (N = 517) received four months of health hygiene education aimed at increasing knowledge of STH prevention. Grade 5 students from the other nine schools (N = 571) served as controls. Absenteeism was measured daily through teachers' attendance logs. After four months of follow-up, overall absenteeism rates at intervention and control schools were not statistically significantly different. However, post-trial non-randomized analyses have shown that students with moderate-to-heavy Ascaris infections and light hookworm infections four months after deworming had, respectively, missed 2.4% (95% CI: 0.1%, 4.7%) and 4.6% (95% CI: 1.9%, 7.4%) more schooldays during the follow-up period than their uninfected counterparts. These results provide empirical evidence of a direct effect of STH infections on absenteeism in school-age children. PMID:25122469

Improved Clinical Efficacy with Wound Support Network Between Hospital and Home Care Service.

PubMed

Bergersen, Tone Kristin; Storheim, Elisabeth; Gundersen, Stina; Kleven, Linn; Johnson, Maria; Sandvik, Leiv; Kvaerner, Kari Jorunn; Ørjasæter, Nils-Otto

2016-11-01

The aim of this study was to test the efficacy of a wound support network model between the primary home care service and the hospital. The impact on wound healing rate, cost benefit, and transfer of knowledge was investigated. The intervention group was exposed to a wound support network (n = 32), and the control group continued standard organization of treatment (n = 21). Nonrandomized controlled study; observations were made before (baseline) and after the implementation of the intervention (12 weeks). Patients with chronic wounds (lasting >6 weeks and with wound area >1 cm) in Oslo, Norway. Closure of the observation wound; wound size; total number of wounds; presence of eczema, edema, and pain; number of dressings per week; time spent per dressing; and number of control appointments at the hospital. The economic impact is calculated for the hospital and for the community of Oslo, Norway. The number of control appointments (t = 3.80, P < .001) was significantly decreased, and the number of completed treatments (P = .02) was significantly increased after 12 weeks in the intervention group compared with the control group. A significant improvement was evident in the intervention group in terms of eczema (P = .02), edema (P = .03), and closing of the observational wound (46.7% cases in the intervention group versus 25.0% in the control group). A wound support network between the primary home care service and the hospital is cost-effective, improves clinical efficacy of the home care services' work, and reduces the need for consultations at the hospital.

Physiotherapy program through home visits for community-dwelling elderly Japanese women with mild knee pain.

PubMed

Konishi, Isamu; Tanabe, Naohito; Seki, Nao; Suzuki, Hiroshi; Okamura, Taro; Shinoda, Kunihiko; Hoshino, Emiko

2009-10-01

Knee pain is extremely common among the elderly, particularly women. Hence, there is an urgent need for applicable community-based intervention models for halting the progression of knee pain and related disabilities in elderly women. We aimed to assess the efficacy of home-visit physiotherapy as a new intervention model. This non-randomized 5-month-long controlled trial enrolled elderly community-dwelling women (aged 60-83 years) with mild knee pain. The intervention consisted of two home visits by a physiotherapist, with instructions on routinely performing muscle-strengthening exercises at home and implementing simple environmental modifications when necessary. Outcome measures were assessed at baseline and 5 months later. The primary outcomes were measured as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a newly devised seiza-style sitting score. People in Japan, especially elderly women, are accustomed to seiza-style sitting that involves kneeling on one's lower legs while resting the buttocks on the heels. The secondary outcomes included quadriceps isometric strength, knee alignment in the frontal and sagittal planes, and passive knee extension range. Forty-two subjects (20 in the intervention group and 22 in the control group) completed the study. At baseline, characteristics and the primary outcomes did not significantly differ between the 2 groups. At 5 months, the primary outcomes improved significantly in the intervention group. Estimated differences in the change from baseline for each outcome between the 2 groups were computed, adjusting for outcome variables imbalanced at baseline. Even after the adjustment, the home-visit physiotherapy regimen provides favorable improvement in the seiza-style sitting score.

Community-based lifestyle modification of cardiovascular disease risks in middle-aged Japanese: a 27-month update.

PubMed

Fujii, Hiroko; Muto, Takashi; Haruyama, Yasuo; Nakade, Makiko; Kobayashi, Emiko; Ishisaki, Kaori; Yamasaki, Akiko

2010-04-01

Lifestyle modification is the cornerstone of preventive management for people with cardiovascular disease risks, such as obesity, hypertension, dyslipidemia and diabetes. This study investigated the effect of a 27-month community-based lifestyle intervention on the reduction of cardiovascular disease risks in middle-aged Japanese. Of 549 participants with cardiovascular disease risk factors of overweight, hypertension, dyslipidemia or diabetes enrolled in this non-randomized controlled study, 397 participants aged 39-71 years old completed all 3 serial surveys at baseline, 15 months and 27 months. For the intervention group (39 males and 174 females), 31 specific interventions including individual counselling and group sessions were conducted. The control group (64 males and 120 females) only received 7 newsletters providing health information and results of health checkups. Multiple logistic regression analysis adjusted for sex, each baseline risk category and age category showed that the proportion of those who were overweight or showed dyslipidemia risk were significantly lower in the intervention group only at 27 months [Odds ratio (OR): 0.43 (95% CI 0.20-0.94), OR: 0.43 (95% CI 0.21-0.87), respectively] and the proportion of those showing diabetes risk was significantly lower in the intervention group at both 15 months [OR: 0.42 (95% CI 0.18-0.97)] and 27 months [OR: 0.56 (95% CI 0.32-0.99)]. In conclusion, the 27-month community-based lifestyle modification of cardiovascular disease risks shows significant reductions in risks of diabetes, overweight and dyslipidemia in middle-aged Japanese.

The impact of a supportive leadership program in a policing organisation from the participants' perspective.

PubMed

Muller, Juanita; Maclean, Rowena; Biggs, Herbert

2009-01-01

The aim of this study is to explore the implementation of an organisational level intervention, focussing on Supportive Leadership (SL), in an Australian police organisation from the perspective of supervisors and managers. The impact of the intervention was explored using a qualitative methodology using semi-structured telephone interviews with 44 participants who had attended the Supportive Leadership Workshop, designed to improve awareness of good management practices. Data was subjected to thematic analysis using a social constructivist theoretical orientation. Findings showed that SL as a concept was generally accepted by a majority of participants and that they had integrated a number of SL strategies into their work practices. The participants also identified the importance of senior personnel role-modelling SL and the negative impact of non-role modelling. RESEARCH LIMITATIONS AND IMPLICATIONS: The major limitation of the study was the non-random sample of voluntary participants. However, the nature of conducting applied studies in police organisations is inherently difficult due to confidentiality and their paramilitary nature. This study highlights the need for future studies in police leadership and occupational stress that directly explore issues from the perspective of the supervisors and managers. Interventions such as SL need support and role modelling from senior management to enhance their credibility. ORIGINAL VALUE: This paper reports on an applied intervention that received major support and funding within a police organisation. It is of value to other organizations considering similar interventions because it highlights issues that could be addressed to further enhance the program.

Effectiveness of social marketing strategies to reduce youth obesity in European school-based interventions: a systematic review and meta-analysis.

PubMed

Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moreno-García, Carlos Francisco; Trujillo Escobar, Tamy Goretty; Solà, Rosa; Giralt, Montse

2016-05-01

The use of social marketing to modify lifestyle choices could be helpful in reducing youth obesity. Some or all of the 8 domains of the National Social Marketing Centre's social marketing benchmark criteria (SMBC) are often used but not always defined in intervention studies. The aim of this review is to assess the effectiveness of European school-based interventions to prevent obesity relative to the inclusion of SMBC domains in the intervention. The PubMed, Cochrane, and ERIC databases were used. Nonrandomized and randomized controlled trials conducted from 1990 to April 2014 in participants aged 5 to 17 years were included. After the study selection, the 8 domains of the SMBC were assessed in each included study. Thirty-eight publications were included in the systematic review. For the meta-analysis, randomized controlled trials (RCTs) reporting body mass index or prevalence of overweight and obesity were considered. Eighteen RCTs with a total of 8681 participants included at least 5 SMBC. The meta-analysis showed a small standardized mean difference in body mass index of -0.25 (95%CI, -0.45 to -0.04) and a prevalence of overweight and obesity odds ratio of 0.72 (95%CI, 0.5-0.97). Current evidence indicates that the inclusion of at least 5 SMBC domains in school-based interventions could benefit efforts to prevent obesity in young people. PROSPERO registration number: CRD42014007297. © The Author(s) 2016. Published by Oxford University Press on behalf of the International Life Sciences Institute.

Effectiveness of social marketing strategies to reduce youth obesity in European school-based interventions: a systematic review and meta-analysis

PubMed Central

Aceves-Martins, Magaly; Llauradó, Elisabet; Tarro, Lucia; Moreno-García, Carlos Francisco; Trujillo Escobar, Tamy Goretty; Giralt, Montse

2016-01-01

Context: The use of social marketing to modify lifestyle choices could be helpful in reducing youth obesity. Some or all of the 8 domains of the National Social Marketing Centre’s social marketing benchmark criteria (SMBC) are often used but not always defined in intervention studies. Objective: The aim of this review is to assess the effectiveness of European school-based interventions to prevent obesity relative to the inclusion of SMBC domains in the intervention. Data Sources: The PubMed, Cochrane, and ERIC databases were used. Study Selection: Nonrandomized and randomized controlled trials conducted from 1990 to April 2014 in participants aged 5 to 17 years were included. Data Extraction: After the study selection, the 8 domains of the SMBC were assessed in each included study. Results: Thirty-eight publications were included in the systematic review. For the meta-analysis, randomized controlled trials (RCTs) reporting body mass index or prevalence of overweight and obesity were considered. Eighteen RCTs with a total of 8681 participants included at least 5 SMBC. The meta-analysis showed a small standardized mean difference in body mass index of −0.25 (95%CI, −0.45 to −0.04) and a prevalence of overweight and obesity odds ratio of 0.72 (95%CI, 0.5–0.97). Conclusion: Current evidence indicates that the inclusion of at least 5 SMBC domains in school-based interventions could benefit efforts to prevent obesity in young people. PROSPERO registration number: CRD42014007297. PMID:27018054

Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

PubMed Central

Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

2017-01-01

Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach. PMID:28208839

The Choice Project: Peer Workers Promoting Shared Decision Making at a Youth Mental Health Service.

PubMed

Simmons, Magenta Bender; Batchelor, Samantha; Dimopoulos-Bick, Tara; Howe, Deb

2017-08-01

In youth mental health services, consumer participation is essential, but few implementation strategies exist to engage young consumers. This project evaluated an intervention implemented in an Australian youth mental health service that utilized peer workers to promote shared decision making via an online tool. All new clients ages 16-25 were invited to participate in this nonrandomized comparative study, which used a historical comparison group (N=80). Intervention participants (N=149) engaged with a peer worker and used the online tool before and during their intake assessment. Pre- and postintake data were collected for both groups; measures included decisional conflict, perceived shared decision making, and satisfaction. A series of paired t tests, analyses of variance, and multiple regressions were conducted to assess differences in scores across intervention and comparison groups and pre- and postintake assessments. Ratings of perceived shared decision making with intake workers were higher in the intervention group than in the comparison group (p=.015). In both groups, decisional conflict scores were significantly lower after the intake assessment (p<.001 for both groups). Both perceived shared decision making and lower decisional conflict were associated with satisfaction (p<.015). Young people who participated in an intervention that combined peer work and shared decision making reported feeling more involved in their assessment. Feeling involved and having lower decisional conflict after seeing an intake worker were important for client satisfaction. These findings demonstrate the importance of both peer work and shared decision making for promoting optimal outcomes in youth mental health services.

The Role of Salivary Neuropeptides in Pediatrics: Potential Biomarkers for Integrated Therapies.

PubMed

Gershan, Lynn A; Durham, Paul L; Skidmore, Jaci; Shimizu, Joshua; Cady, Ryan J; Sheng, Xiaoming; Maloney, Christopher G

2015-08-01

Objective measures of symptom response to integrated complementary approaches in pediatrics are evolving. The purpose of this study was to document the concentration range of salivary neuropeptides in healthy controls and in children with cancer, to explore correlations between serum and salivary measurements for Calcitonin Gene-Related Peptide (CGRP) and Vasoactive Intestinal Polypeptide (VIP), and to determine whether there is a change in these salivary neuropeptide levels in response to integrated mind-body therapies. A non-randomized pragmatic study with three phases: Phase 1- Healthy Control Saliva-10 healthy controls provided saliva samples; Phase 2- Cancer Diagnosis Serum-Saliva- 16 mixed-type cancer patients provided blood and saliva samples; Phase 3- Acute Lymphocytic Leukemia (ALL) Saliva Intervention- 12 patients with ALL provided pre- and post-complementary intervention saliva samples. 20-minutes of structured touch or scripted relaxation breathing were administered to patients in Phase 3; Phase 1 and 2 patients did not receive this intervention. cortisol, CGRP, VIP, State/Trait Anxiety Scale, visual analogue scale, vital signs. Salivary CGRP and VIP were similar for children in Phases 1 and 2. There was a correlation between serum and salivary VIP in the mixed cancer group, though not between serum and salivary CGRP. In Phase 3 children, following a complementary intervention, salivary CGRP, heart rate, and systolic blood pressure decreased. These data provide evidence of a decrease in sympathetic output after integrative/complementary therapy intervention in children with cancer. The study underscores the potential role of salivary neuropeptides as non-invasive biomarkers for integrated therapies in pediatrics.

Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial.

PubMed

Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

2017-02-13

Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named "HAPPY ME," which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10-12 years of age using HAPPY ME. A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

Evaluating the impact of direct and indirect contact on the mental health stigma of pharmacy students.

PubMed

Nguyen, Elizabeth; Chen, Timothy F; O'Reilly, Claire L

2012-07-01

Contact with mental health consumers has shown to be a promising strategy to address mental health stigma, particularly in the context of pharmacy education. This research aimed to compare the effectiveness of a direct (face-to-face) contact intervention with an indirect (film based) contact intervention in reducing the mental health stigma of pharmacy students. A two-group, non-randomized, comparative study was conducted with third year pharmacy students (n = 198) allocated to the direct contact arm and fourth year pharmacy students (n = 278) allocated to the indirect contact arm. Baseline and immediate post-intervention data were collected using a validated 39 item survey instrument to assess the impact of the interventions on mental health stigma as well as attitudes towards providing mental health pharmaceutical services. Participants in the direct contact group showed a significant improvement in 37 out of 39 survey items and participants in the indirect contact group showed a significant improvement in 27 out of 39 items (P < 0.05). While direct contact had a stronger impact than indirect contact for 22 items (P < 0.05), for numerous key measures of mental health stigma the impact of the two contact interventions was equivalent. Both indirect and direct contact may positively impact mental health stigma. While the strength of the stigma-change process may be heightened by face-to-face interactions, the largely positive impact of indirect contact suggests that stigma reduction may depend less on the medium of contact but more on the transcendent messages contributed by the consumers facilitating the contact experience.

A Review of Marital Intimacy-Enhancing Interventions among Married Individuals

PubMed Central

Kardan-Souraki, Maryam; Hamzehgardeshi, Zeinab; Asadpour, Ismail; Mohammadpour, Reza Ali; Khani, Soghra

2016-01-01

Background: Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage. Search Methods: In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, Cochrane Library, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study. Main Results: 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy. Authors’ Conclusions: Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships. PMID:27045400

A Review of Marital Intimacy-Enhancing Interventions among Married Individuals.

PubMed

Kardan-Souraki, Maryam; Hamzehgardeshi, Zeinab; Asadpour, Ismail; Mohammadpour, Reza Ali; Khani, Soghra

2016-08-01

Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage. In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, Cochrane Library, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study. 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy. Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.

A systematic review and meta-analysis: Effectiveness of internet empowerment-based self-management interventions on adults with metabolic diseases.

PubMed

Kuo, Chia-Chi; Su, Yu-Jen; Lin, Chiu-Chu

2018-03-25

To synthesize the effects of Internet empowerment-based self-management interventions on adults with metabolic diseases. Metabolic diseases are prevalent and burden healthcare systems; they have become a major health problem worldwide. The effects of IESMIs on lifestyle changes have been shown to improve adults' physiological and psychological conditions. However, we found no systematic review evaluating these effects. Systematic review and meta-analysis of randomized and non-randomized controlled trials, conducted according to the Cochrane handbook. A literature search was conducted using the Airiti Library, Association for Computing Machinery, CINAHL, Cochrane Library, Embase, ProQuest, PubMed/MEDLINE and Index of the Taiwan Periodical Literature System databases (earliest-June 2016). Two reviewers used the Cochrane Collaboration bias assessment tool to assess the methodological quality of included studies. Extracted data were entered and analysed using RevMan 5.3.5 software. Inverse variance was used to estimate effect sizes. Weighted and standardized mean differences with 95% confidence intervals were calculated using a random effects model. Subgroup and sensitivity analyses were performed. Twenty-one randomized controlled trials were reviewed. Meta-analysis showed that the intervention significantly improved adults' exercise habits, glycated haemoglobin (HbA1c) levels, body weight, empowerment levels and quality of life. The intervention significantly improve the health status of adults with metabolic diseases, in particular their exercise habits, HbA1c levels, body weight, empowerment and quality of life. The intervention provides more convenient and faster access to healthcare for busy individuals with time constraints. These results suggest that healthcare professionals could develop accessible and friendly interactive online interfaces for patients to expand the use of these interventions in the clinical setting. © 2018 John Wiley & Sons Ltd.

Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses.

PubMed

Rehackova, L; Arnott, B; Araujo-Soares, V; Adamson, A A; Taylor, R; Sniehotta, F F

2016-05-01

To explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes. Controlled trials and qualitative studies of individuals with Type 2 diabetes that compared very low energy diets with standard care, minimal interventions, other weight loss interventions, less intensive very low energy diet interventions and very low energy diets with additional components were eligible for inclusion. Meta-analyses of changes in weight, blood glucose levels and attrition rates were performed. Acceptability of very low energy diets was assessed by attrition rates, number and severity of side effects, and by qualitative evaluations of the interventions. Four randomized, five non-randomized controlled trials and no qualitative studies (21 references, 9 studies, 346 participants) were identified. Meta-analyses showed that very low energy diets induced greater weight losses than minimal interventions, standard care or low energy diets at 3 and 6 months. No conclusive evidence for differences in outcomes between very low energy diets and Roux-en-Y gastric bypass surgery was found. Greater differences in energy prescription between intervention and comparator arms were associated with greater differences in weight loss and fasting blood glucose levels at 3 months. Attrition rates did not differ between the very low energy diets and the comparator arms at any measurement point. Very low energy diets are effective in substantial weight loss among people with Type 2 diabetes. Levels of adherence to very low energy diets in controlled studies appear to be high, although details about behaviour support provided are usually poorly described. © 2015 Diabetes UK.

Physiotherapy intervention in Alzheimer's disease: systematic review and meta-analysis.

PubMed

Zhu, Xi-Chen; Yu, Yang; Wang, Hui-Fu; Jiang, Teng; Cao, Lei; Wang, Chong; Wang, Jun; Tan, Chen-Chen; Meng, Xiang-Fei; Tan, Lan; Yu, Jin-Tai

2015-01-01

Many studies reported that physiotherapy interventions are available to treat Alzheimer's disease (AD), but the efficacy remains uncertain. To evaluate the effectiveness of physiotherapy intervention on AD. The data sources were searched from literature databases, journals, and reference lists from 1 January 1990 to the end of 1 April 2014. Randomized and non-randomized controlled trials with physiotherapy intervention were included in our meta-analysis. Jadad score and Newcastle-Ottawa scale were used to assess the quality of included trials. Outcome measures were cognition function, physical function, activity of daily life (ADL) and neuropsychiatric inventory (NPI). 23 trials met the inclusion standard finally. Significant changes were seen in cognitive function: Mini-Mental State Examination score (weighted mean difference (WMD): 1.84, 95% confidence interval (CI): [0.76, to, 2.93], p < 0.0001), and verbal fluency (standard mean difference (SMD): 0.34, 95% CI: [0.01 to 0.66], p = 0.04). Other outcomes are also significant, they were timed up and go test (SMD: 0.56, 95% CI: [0.30 to 0.83], p < 0.0001), berg functional balance scale (SMD: 1.11, 95% CI: [0.37 to 1.84], p = 0.003), 6-min walk distance test (SMD: 141.45, 95% CI: [11.72 to 271.18], p = 0.03), ADL (SMD: 0.78, 95% CI: [0.33 to 1.23], p = 0.0007) and NPI (SMD: -0.69, 95% CI: [-1.31 to -0.07], p = 0.03). The available data indicate that physiotherapy intervention may have benefits in AD. However, current data are not definitive; more carefully designed and conducted observational studies are needed to definitively establish that whether physiotherapy intervention can effectively alleviate symptoms of AD.

Effectiveness of different interventions in public nurseries based on food and nutrition education: promoting breast-feeding and healthy complementary feeding.

PubMed

Cândido, Naiara Abrantes; de Sousa, Taciana Maia; Dos Santos, Luana Caroline

2018-05-10

Food practices in the early years of life are important to form healthy eating habits; therefore, it is essential for the caregivers of infants to receive appropriate guidance. The present study aimed to investigate the effectiveness of different nutritional interventions on complementary feeding practices in municipal nurseries. Non-randomized controlled intervention study with education professionals and parents of infants (<2 years). Participants were divided into: control group (CG), standard food and nutrition education in writing; and intervention group (IG), the same information as the CG and face-to-face meetings (professionals, 8 h; parents, 5 h). Changes in professionals' knowledge on the subject and alterations in parents' beliefs, attitudes and intentions were assessed using questionnaires before and after the educational activities. Ten public nurseries in Nova Lima, Belo Horizonte, Minas Gerais, Brazil, 2015. Ninety professionals (fifty in CG; forty in IG) and 169 parents (ninety-seven in CG; seventy-two in IG). After the intervention, there was a significant increase in the mean number of correct responses given by professionals in the IG (12·2 v. 10·7; P=0·001). In addition, there were improvements among the parents of the IG in relation to beliefs (soups and broths do not nourish my child: P=0·012), attitudes (offer meat from the sixth month: P=0·032) and intentions (do not offer soups and broths: P=0·003; offer vegetables: P=0·018; offer meat: P<0·001). Face-to-face nutritional intervention had a significantly greater effect on the parameters evaluated, indicating the importance of adequate guidance in childcare services to support the introduction of complementary feeding.

A process-model based approach to prospective memory impairment in Parkinson's disease.

PubMed

Kliegel, Matthias; Altgassen, Mareike; Hering, Alexandra; Rose, Nathan S

2011-07-01

The present review discusses the current state of research on the clinical neuropsychology of prospective memory in Parkinson's disease. To do so the paper is divided in two sections. In the first section, we briefly outline key features of the (partly implicit) rationale underlying the available literature on the clinical neuropsychology of prospective memory. Here, we present a conceptual model that guides our approach to the clinical neuropsychology of prospective memory in general and to the effects of Parkinson's disease on prospective memory in particular. In the second section, we use this model to guide our review of the available literature and suggest some open issues and future directions motivated by previous findings and the proposed conceptual model. The review suggests that certain phases of the prospective memory process (intention formation und initiation) are particularly impaired by Parkinson's disease. In addition, it is argued that prospective memory may be preserved when tasks involve specific features (e.g., focal cues) that reduce the need for strategic monitoring processes. In terms of suggestions for future directions, it is noted that intervention studies are needed which target the specific phases of the prospective memory process that are impaired in Parkinson's disease, such as planning interventions. Moreover, it is proposed that prospective memory deficits in Parkinson's disease should be explored in the context of a general impairment in the ability to form an intention and plan or coordinate an appropriate series of actions. Copyright © 2011 Elsevier Ltd. All rights reserved.

Qualitative study to explore Prospect Theory and message framing and diet and cancer prevention-related issues among African American adolescents.

PubMed

Satia, Jessie A; Barlow, Jameta; Armstrong-Brown, Janelle; Watters, Joanne L

2010-01-01

There is a dearth of knowledge regarding factors that may motivate African American adolescents to consume healthier diets. To develop and test cancer prevention messages based on Prospect Theory on motivation to improve dietary intake in African American adolescents and to explore other salient factors that may inform dietary intervention design and implementation in this population. Semistructured in-person qualitative interviews were conducted with 13 African American male and female adolescents, aged 12 to 16 years, in North Carolina. Prospect Theory and message framing were used to guide the design of the 4 sets of diet-related messages related to cancer prevention: short-term, gain-framed; long-term, gain-framed; short-term, loss-framed; and long-term, loss-framed messages. Data were also collected on demographic, behavioral, and psychological factors; usual health behaviors; and preferences for intervention delivery. Most respondents found the gain-framed, short-term messages most salient for both fruits/vegetables (8 [61.5%]) and fat consumption (7 [53.8%]). For fat consumption only, 2 (15.4%) found the loss-framed, short-term messages pertinent; none found the loss-framed, long-term messages relevant for either dietary variable. All indicated interest in participating in a dietary intervention/education program; most preferred the Internet as a channel for intervention delivery. Participants expressed diverse views regarding knowledge, attitudes, and beliefs regarding healthy eating. The gain-framed, short-term messages were most salient for motivating the majority of respondents to consume a healthy diet and most expressed a strong interest in participating in programs about diet and nutrition, with the Internet as the preferred communication channel. Researchers conducting dietary interventions and education initiatives and medical professionals who counsel African American adolescents should consider using Prospect Theory as a theoretical framework, should focus on gain-framed, short-term messages regarding cancer prevention, and should use the Internet for data collection and intervention and information delivery.

Contrast media extravasations in patients undergoing computerized tomography scanning: a systematic review and meta-analysis of risk factors and interventions

PubMed Central

Ding, Sandrine; Meystre, Nicole Richli; Campeanu, Cosmin; Gullo, Giuseppe

2018-01-01

ABSTRACT Objective: To identify risk factors and interventions preventing or reducing contrast medium extravasation. Introduction: Computed tomography (CT) is a radiological examination essential for the diagnosis and monitoring of many diseases. It is often performed with the intravenous (IV) injection of contrast agents. Use of these products can result in a significant complication, extravasation, which is the accidental leakage of IV material into the surrounding tissue. Patients may feel a sharp pain and skin ulceration or necrosis may develop. Inclusion criteria: This review considered studies that included patients (adults and children) undergoing a CT with IV administration of contrast media. The risk factors considered were patient demographics, comorbidities and medication history. This review also investigated any strategies related to: contrast agent, injection per se, material used for injection, apparatus used, healthcare professionals involved, and patient risk assessment performed by the radiology personnel. The comparators were other interventions or usual care. This review investigated randomized controlled trials and non-randomized controlled trials. When neither of these were available, other study designs, such as prospective and retrospective cohort studies, case-control studies and case series, were considered for inclusion. Primary outcomes considered were: extravasation frequency, volume, severity and complications. Methods: The databases PubMed, CINAHL, Embase, the Cochrane Register of Controlled Trials, Web of Science PsycINFO, ProQuest Dissertations and Theses A&I, TRIP Database and ClinicalTrials.gov were searched to find both published and unpublished studies from 1980 to September 2016. Papers were assessed by two independent reviewers for methodological validity using the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). Data were extracted using the standardized data extraction tool from JBI SUMARI. In one case, quantitative data from two cohort studies were pooled in a statistical meta-analysis. However, generally, statistical pooling was not possible due to heterogeneity of the interventions, populations of interest or outcomes. Accordingly, the findings have been presented in narrative form. Results: Fifteen articles were selected from a total of 2151 unique studies identified. Two were randomized controlled trials and 13 were quasi-experimental and observational studies. The quality of these studies was judged to be low to moderate. Some patient characteristics, such as female sex and inpatient status, appeared to be risk factors for extravasation. Additionally, injection rate, venous access site and catheter dwelling time could affect the volume extravasated. Preliminary studies seemed to indicate the potential of extravasation detection accessories to identify extravasation and reduce the volume extravasated. The other interventions either did not result in significant reduction in the frequency/volume of extravasation, or the results were mixed across the studies. Conclusions: The majority of the studies included in this review evaluated the outcomes of extravasation frequency and volume. Given the quality of the primary studies, this systematic review identified only potential risk factors and interventions. It further highlighted the research gap in this area and the importance of conducting trials with solid methodological designs. PMID:29324560

A Systematic Review and Meta-Analysis of Strength Training in Individuals With Multiple Sclerosis Or Parkinson Disease

PubMed Central

Cruickshank, Travis M.; Reyes, Alvaro R.; Ziman, Melanie R.

2015-01-01

Abstract Strength training has, in recent years, been shown to be beneficial for people with Parkinson disease and multiple sclerosis. Consensus regarding its utility for these disorders nevertheless remains contentious among healthcare professionals. Greater clarity is required, especially in regards to the type and magnitude of effects as well as the response differences to strength training between individuals with Parkinson disease or multiple sclerosis. This study examines the effects, magnitude of those effects, and response differences to strength training between patients with Parkinson disease or multiple sclerosis. A comprehensive search of electronic databases including Physiotherapy Evidence Database scale, PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL was conducted from inception to July 2014. English articles investigating the effect of strength training for individuals with neurodegenerative disorders were selected. Strength training trials that met the inclusion criteria were found for individuals with Parkinson disease or multiple sclerosis. Individuals with Parkinson disease or multiple sclerosis were included in the study. Strength training interventions included traditional (free weights/machine exercises) and nontraditional programs (eccentric cycling). Included articles were critically appraised using the Physiotherapy Evidence Database scale. Of the 507 articles retrieved, only 20 articles met the inclusion criteria. Of these, 14 were randomized and 6 were nonrandomized controlled articles in Parkinson disease or multiple sclerosis. Six randomized and 2 nonrandomized controlled articles originated from 3 trials and were subsequently pooled for systematic analysis. Strength training was found to significantly improve muscle strength in people with Parkinson disease (15%–83.2%) and multiple sclerosis (4.5%–36%). Significant improvements in mobility (11.4%) and disease progression were also reported in people with Parkinson disease after strength training. Furthermore, significant improvements in fatigue (8.2%), functional capacity (21.5%), quality of life (8.3%), power (17.6%), and electromyography activity (24.4%) were found in individuals with multiple sclerosis after strength training. The limitations of the study were the heterogeneity of interventions and study outcomes in Parkinson disease and multiple sclerosis trials. Strength training is useful for increasing muscle strength in Parkinson disease and to a lesser extent multiple sclerosis. PMID:25634170

A systematic review and meta-analysis of strength training in individuals with multiple sclerosis or Parkinson disease.

PubMed

Cruickshank, Travis M; Reyes, Alvaro R; Ziman, Melanie R

2015-01-01

Strength training has, in recent years, been shown to be beneficial for people with Parkinson disease and multiple sclerosis. Consensus regarding its utility for these disorders nevertheless remains contentious among healthcare professionals. Greater clarity is required, especially in regards to the type and magnitude of effects as well as the response differences to strength training between individuals with Parkinson disease or multiple sclerosis. This study examines the effects, magnitude of those effects, and response differences to strength training between patients with Parkinson disease or multiple sclerosis. A comprehensive search of electronic databases including Physiotherapy Evidence Database scale, PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and CINAHL was conducted from inception to July 2014. English articles investigating the effect of strength training for individuals with neurodegenerative disorders were selected. Strength training trials that met the inclusion criteria were found for individuals with Parkinson disease or multiple sclerosis. Individuals with Parkinson disease or multiple sclerosis were included in the study. Strength training interventions included traditional (free weights/machine exercises) and nontraditional programs (eccentric cycling). Included articles were critically appraised using the Physiotherapy Evidence Database scale. Of the 507 articles retrieved, only 20 articles met the inclusion criteria. Of these, 14 were randomized and 6 were nonrandomized controlled articles in Parkinson disease or multiple sclerosis. Six randomized and 2 nonrandomized controlled articles originated from 3 trials and were subsequently pooled for systematic analysis. Strength training was found to significantly improve muscle strength in people with Parkinson disease (15%-83.2%) and multiple sclerosis (4.5%-36%). Significant improvements in mobility (11.4%) and disease progression were also reported in people with Parkinson disease after strength training. Furthermore, significant improvements in fatigue (8.2%), functional capacity (21.5%), quality of life (8.3%), power (17.6%), and electromyography activity (24.4%) were found in individuals with multiple sclerosis after strength training. The limitations of the study were the heterogeneity of interventions and study outcomes in Parkinson disease and multiple sclerosis trials. Strength training is useful for increasing muscle strength in Parkinson disease and to a lesser extent multiple sclerosis.

Community-Based Adaptive Physical Activity Program for Chronic Stroke: Feasibility, Safety, and Efficacy of the Empoli Model

PubMed Central

Stuart, Mary; Benvenuti, Francesco; Macko, Richard; Taviani, Antonio; Segenni, Lucianna; Mayer, Federico; Sorkin, John D.; Stanhope, Steven J.; Macellari, Velio; Weinrich, Michael

2010-01-01

Objective To determine whether Adaptive Physical Activity (APA-stroke), a community-based exercise program for participants with hemiparetic stroke, improves function in the community. Methods Nonrandomized controlled study in Tuscany, Italy, of participants with mild to moderate hemiparesis at least 9 months after stroke. Forty-nine participants in a geographic health authority (Empoli) were offered APA-stroke (40 completed the study). Forty-four control participants in neighboring health authorities (Florence and Pisa) received usual care (38 completed the study). The APA intervention was a community-based progressive group exercise regimen that included walking, strength, and balance training for 1 hour, thrice a week, in local gyms, supervised by gym instructors. No serious adverse clinical events occurred during the exercise intervention. Outcome measures included the following: 6-month change in gait velocity (6-Minute Timed Walk), Short Physical Performance Battery (SPPB), Berg Balance Scale, Stroke Impact Scale (SIS), Barthel Index, Hamilton Rating Scale for Depression, and Index of Caregivers Strain. Results After 6 months, the intervention group improved whereas controls declined in gait velocity, balance, SPPB, and SIS social participation domains. These between-group comparisons were statistically significant at P < .00015. Individuals with depressive symptoms at baseline improved whereas controls were unchanged (P < .003). Oral glucose tolerance tests were performed on a subset of participants in the intervention group. For these individuals, insulin secretion declined 29% after 6 months (P = .01). Conclusion APA-stroke appears to be safe, feasible, and efficacious in a community setting. PMID:19318465

What Peer Mentoring Adds to Already Good Patient Care: Implementing the Carpeta Roja Peer Mentoring Program in a Well-Resourced Health Care System.

PubMed

Knox, Lyndee; Huff, Jessica; Graham, Deborah; Henry, Michelle; Bracho, America; Henderson, Cynthia; Emsermann, Caroline

2015-08-01

The purpose of this study was to evaluate the impact of a peer support program on the health outcomes of patients already receiving well-organized, comprehensive diabetes care. We used a mixed-methods, nonrandomized, control-group design to evaluate the impact of a peer-mentoring program on the health outcomes and self-management behaviors of adults with type 2 diabetes in 15 primary care practices in San Antonio. Propensity score analysis, t-tests, and multivariable repeated analyses were used to evaluate impact. Qualitative interviews were conducted with 15 participants in the intervention group and analyzed using a grounded theory approach. Both intervention and control groups showed significant improvement on all health indicators from baseline to 6-month follow-up (P<.001). Hemoglobin A1c (HbA1c) decreased slightly faster for patients in the intervention group (P=.04). Self-management behaviors improved significantly from baseline to 6-month follow-up for the intervention group. Interviewed participants also reported reductions in social isolation and extension of impact of health behavior changes to multiple generations of family members. The addition of peer mentoring to already well-organized comprehensive diabetes care does not improve outcomes. However, findings suggest that the impact of the program extends to members of the participants' families, which is an intriguing finding that deserves further study. © 2015 Annals of Family Medicine, Inc.

Post-traumatic stress disorder in older adults: a systematic review of the psychotherapy treatment literature.

PubMed

Dinnen, Stephanie; Simiola, Vanessa; Cook, Joan M

2015-01-01

Older adults represent the fastest growing segment of the US and industrialized populations. However, older adults have generally not been included in randomized clinical trials of psychotherapy for post-traumatic stress disorder (PTSD). This review examined reports of psychological treatment for trauma-related problems, primarily PTSD, in studies with samples of at least 50% adults aged 55 and older using standardized measures. A systematic review of the literature was conducted on psychotherapy for PTSD with older adults using PubMed, Medline, PsychInfo, CINAHL, PILOTS, and Google Scholar. A total of 42 studies were retrieved for full review; 22 were excluded because they did not provide at least one outcome measure or results were not reported by age in the case of mixed-age samples. Of the 20 studies that met review criteria, there were: 13 case studies or series, three uncontrolled pilot studies, two randomized clinical trials, one non-randomized concurrent control study and one post hoc effectiveness study. Significant methodological limitations in the current older adult PTSD treatment outcome literature were found reducing its internal validity and generalizability, including non-randomized research designs, lack of comparison conditions and small sample sizes. Select evidence-based interventions validated in younger and middle-aged populations appear acceptable and efficacious with older adults. There are few treatment studies on subsets of the older adult population including cultural and ethnic minorities, women, the oldest old (over 85), and those who are cognitively impaired. Implications for clinical practice and future research directions are discussed.

The positive deviance/hearth approach to reducing child malnutrition: systematic review.

PubMed

Bisits Bullen, Piroska A

2011-11-01

The Positive Deviance/Hearth approach aims to rehabilitate malnourished children using practices from mothers in the community who have well-nourished children despite living in poverty. This study assesses its effectiveness in a range of settings. Systematic review of peer reviewed intervention trials and grey literature evaluation reports of child malnutrition programs using the Positive Deviance/Hearth approach. Ten peer reviewed studies and 14 grey literature reports met the inclusion criteria. These described results for 17 unique Positive Deviance/Hearth programs in 12 countries. Nine programs used a pre- and post-test design without a control, which limited the conclusions that could be drawn. Eight used more robust designs such as non-randomized trials, non-randomized cross-sectional sibling studies and randomized controlled trials (RCTs). Of the eight programs that reported nutritional outcomes, five reported some type of positive result in terms of nutritional status - although the improvement was not always as large as predicted, or across the entire target population. Both the two RCTs demonstrated improvements in carer feeding practices. Qualitative results unanimously reported high levels of satisfaction from participants and recipient communities. Overall this study shows mixed results in terms of program effectiveness, although some Positive Deviance/Hearth programs have clearly been successful in particular settings. Sibling studies suggest that the Positive Deviance/Hearth approach may have a role in preventing malnutrition, not just rehabilitation. Further research is needed using more robust study designs and larger sample sizes. Issues related to community participation and consistency in reporting results need to be addressed. © 2011 Blackwell Publishing Ltd.

Critical appraisal of nonrandomized studies-A review of recommended and commonly used tools.

PubMed

Quigley, Joan M; Thompson, Juliette C; Halfpenny, Nicholas J; Scott, David A

2018-02-27

When randomized controlled trial data are limited or unavailable, or to supplement randomized controlled trial evidence, health technology assessment (HTA) agencies may rely on systematic reviews of nonrandomized studies (NRSs) for evidence of the effectiveness of health care interventions. NRS designs may introduce considerable bias into systematic reviews, and several methodologies by which to evaluate this risk of bias are available. This study aimed to identify tools commonly used to assess bias in NRS and determine those recommended by HTA bodies. Appraisal tools used in NRS were identified through a targeted search of systematic reviews (January 2013-March 2017; MEDLINE and EMBASE [OVID SP]). Recommendations for the critical appraisal of NRS by expert review groups and HTA bodies were reviewed. From the 686 studies included in the narrative synthesis, 48 critical appraisal tools were identified. Commonly used tools included the Newcastle-Ottawa Scale, the methodological index for NRS, and bespoke appraisal tools. Neither the Cochrane Handbook nor the Centre for Reviews and Dissemination recommends a particular instrument for the assessment of risk of bias in NRS, although Cochrane has recently developed their own NRS critical appraisal tool. Among HTA bodies, only the Canadian Agency for Drugs and Technologies in Health recommends use of a specific critical appraisal tool-SIGN 50 (for cohort or case-control studies). Several criteria including reporting, external validity, confounding, and power were examined. There is no consensus between HTA groups on the preferred appraisal tool. Reviewers should select from a suite of tools on the basis of the design of studies included in their review. © 2018 John Wiley & Sons, Ltd.

Diabetes and cardiovascular disease interventions by community pharmacists: a systematic review.

PubMed

Evans, Charity D; Watson, Erin; Eurich, Dean T; Taylor, Jeff G; Yakiwchuk, Erin M; Shevchuk, Yvonne M; Remillard, Alfred; Blackburn, David

2011-05-01

To systematically review and assess the quality of studies evaluating community pharmacist interventions for preventing or managing diabetes or cardiovascular disease (CVD) and/or their major risk factors. A comprehensive literature search was performed using MEDLINE (1950-February 2011), EMBASE (1980-February 2011), International Pharmaceutical Abstracts (1970-February 2011), Cumulative Index to Nursing and Allied Health Literature (1982-June 2007), and Cochrane Central Register of Controlled Trials (1898-February 2011). Search terms included: community pharmacy(ies), community pharmacist(s), cardiovascular, diabetes, and intervention. The grey literature was searched using the ProQuest Dissertations and Theses, Theses Canada, and OAlster databases. Articles published in English or French with all study designs were considered for the review. Studies were included if they contained interventions designed to reduce the incidence, risk, or mortality of CVD or diabetes; affect clinical indicators of CVD or diabetes mellitus (including hypertension, dyslipidemia, or hemoglobin A(1c)); and/or improve adherence to treatment strategies. Only studies involving interventions carried out primarily by pharmacists in community pharmacy settings were included. Study quality was assessed using a checklist validated for both randomized and nonrandomized studies. A total of 4142 studies were initially identified, with 40 meeting our inclusion criteria. Eleven studies were randomized controlled trials, 4 were cluster randomized trials, and 2 studies had randomized before-after designs. The remaining studies were controlled before-after (n = 2), cohort (n = 4), and uncontrolled before-after (n = 17) designs. Interventions focused on diabetes (n = 12), hypertension (n = 9), medication adherence (n = 9), lipids (n = 5), evidence-based medication initiation or optimization (n = 3), risk factor prediction scores (n = 1), and body mass index (n = 1). All studies contained interventions focused at the patient level and the majority of studies (34/40) involved interventions directed at both the physician and patient. No specific intervention emerged as superior, and study quality was generally poor, making it difficult to determine the true effect of the interventions. Poor study quality, time-intensive interventions, and unproven clinical significance warrant the need for further high-quality studies of community pharmacist interventions for preventing or managing diabetes or CVD and/or their major risk factors.

[Effect of comprehensive intervention on capacity in prevention and control of chronic diseases in community medical staff in Hangzhou].

PubMed

Liu, Qingmin; Liu, Bing; Ren, Yanjun; Cao, Chengjian; Lyu, Jun; Li, Liming

2015-11-01

To evaluate the effect of the Oxford Health Alliance-Community Interventions for Health on chronic diseases prevention and control capacity in community medical staff in Hangzhou. A two year comprehensive intervention on chronic disease prevention and control capacity was conducted in the medical staff in Xiacheng district and Gongshu district, Xihu district was used as control according to the study design principal of parallel comparison and non-random grouping. The intervention effect was evaluated with Cochran-Mantel-Haenszel test. A total of 985 questionnaires were completed in the baseline survey and 870 questionnaires were completed in the follow-up survey. After 2 year intervention, the detection rates of blood cholesterol, blood pressure and fasting blood glucose by community medical staff significantly increased compared with the rates before the intervention (χ² =7.97, P =0.05 ; χ² =27.21, P =0.00 ; χ² =21.32, P=0.00). While, in the control district, the fasting blood glucose detection rate increased from 25.37% to 31.19%, the differences showed statistical significance (χ² =15.29, P=0.00). The communication between community medical staff and patients about healthy diet pattern was improved after the intervention, the difference was statistical significant (χ² =8.64, P=0.03). However, no significant differences in communication about increasing physical activity and smoking cessation between community medical staff and patients was found before and after intervention both in intervention districts and in control district. Furthermore, multivariate logistic regression analysis indicated that the interventions on screening of common chronic diseases and management of chronic diseases patients were related with the detections of blood cholesterol, blood pressure and fasting blood glucose. Moreover, the intervention on counsel and suggestion for chronic disease prevention and control had some influence on the communication about chronic disease risk factors between community medical staff and patients. The intervention on chronic disease prevention and control capacity in community medical staff was effective to improve the detection of chronic diseases in community and the communication between the medical staff and patients.

Effects of early comprehensive interventions on child neurodevelopment in poor rural areas of China: a moderated mediation analysis.

PubMed

Liu, S; Wang, Z; Zhao, C; Huang, X; Liang, X; Wang, X; Lu, S; Scherpbier, R W

2018-06-01

To examine the effects of early comprehensive interventions on home environment and child neurodevelopment among children younger than 3 years in poor rural areas of China, as well as the underlying mediating and moderating mechanisms. Non-randomized intervention study was conducted among 216 children aged 0-3 years in Shanxi province of China. Based on a 2 × 2 factor design, children in Lin and Fenxi County were assigned to an intervention group with duration less than 1 year (n = 26) or an intervention group with duration longer than 1 year (n = 82), while children in Fangshan County served as a control group with duration less than 1 year (n = 30) or a control group with duration longer than 1 year (n = 78). The control group received national public health services (NPHS), while the intervention group received NPHS plus comprehensive interventions covering health, nutrition, early psychosocial stimulation, and child protection. Home environment (Infant-Toddler Home Observation for Measurement of the Environment [HOME]) and child neurodevelopment (Ages and Stages Questionnaire [ASQ]) were measured by observation and interview with mothers after the intervention program. The intervention group showed significantly higher overall HOME, organization, learning materials, and involvement than the control group, only for a duration longer than 1 year. Children in the intervention group performed better in overall ASQ, fine motor, problem-solving, and personal-social than children in the control group. Moderated mediation analyses indicated that there were significantly indirect effects of treatment on overall ASQ through overall HOME, organization, and involvement only when the duration was longer than 1 year. Early comprehensive interventions longer than 1 year improve home environment and promote child neurodevelopment among children younger than 3 years in poor rural areas. What is more, effects of early comprehensive interventions longer than 1 year on child neurodevelopment were mediated by home environment. Copyright © 2018 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Correlates and predictors of colorectal cancer screening among male automotive workers.

PubMed

McQueen, Amy; Vernon, Sally W; Myers, Ronald E; Watts, Beatty G; Lee, Eun Sul; Tilley, Barbara C

2007-03-01

Most studies examining factors associated with colorectal cancer (CRC) screening (CRCS) are cross-sectional and thus temporal relationships cannot be determined. Furthermore, less attention has been paid to psychosocial predictors of CRCS. We examined both cross-sectional correlates of prior CRCS and predictors of prospective CRCS initiation and maintenance during The Next Step Trial, a 2-year worksite behavioral intervention to promote regular CRCS and dietary change. The sample included 2,693 White male automotive workers at increased occupational risk for, but no history of, CRC who completed a baseline survey. Stratified analyses were conducted for three dependent variables (prior CRCS, CRCS initiation, and CRCS maintenance). We also assessed prior CRCS as a moderator in prospective analyses. Multivariable logistic regression analyses with generalized linear mixed models were used to adjust for cluster sampling. Except for education, cross-sectional correlates of prior CRCS including older age, family history of CRC or polyps, personal history of polyps, self-efficacy, family support, and intention were also significant prospective predictors of increased CRCS during the trial. Despite differences in the patterns of association for CRCS initiation and maintenance in stratified analyses, the only associations with prospective CRCS that were significantly moderated by prior CRCS were family history and CRCS availability. Correlates of prior CRCS that also were prospective predictors of CRCS may be suitable targets for intervention. Additionally, intervention messages addressing psychosocial constructs may be relevant for both CRCS initiation and maintenance. However, studies with more diverse samples are needed to replicate the results reported here.

The Whole Is Greater than the Sum of the Parts: The Effects of an Antenatal Orientation Interviews Training for Prospective Parents Postnatal Depression Levels

ERIC Educational Resources Information Center

Bulut, Pinar; Barut, Yasar

2016-01-01

The aim of this study was to examine an antenatal orientation interviews training for prospective parents' postnatal depression levels. A quasi-experimental study carried out with 26 (12 experimental, 14 control) prospective mother and father. Participants completed the Edinburgh Postnatal Depression Scale one week before the intervention and 12…

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study

DTIC Science & Technology

2006-12-01

Resuscitative Hyperkalemia in Noncrush Trauma: A Prospective, Observational Study Robert M. Perkins,*† Matthew C. Aboudara,* Kevin C. Abbott,*† and...Surgical Research, San Antonio, Texas The trauma patient is exposed to physiologic processes and life-saving interventions that predispose to hyperkalemia ...in the care of the massively traumatized patient may or may not increase the risk for hyperkalemia . This prospective, observational study was

Effectiveness of Psychosocial Interventions in Complex Palliative Care Patients: A Quasi-Experimental, Prospective Multicenter Study.

PubMed

Mateo-Ortega, Dolors; Gómez-Batiste, Xavier; Maté, Jorge; Beas, Elba; Ela, Sara; Lasmarias, Cristina; Limonero, Joaquín T

2018-03-13

To determine whether specific psychosocial interventions can ease discomfort in palliative care (PC) patients, particularly in those with high levels of pain or emotional distress. Changes in the psychological parameters of 8333 patients were assessed in a quasi-experimental, prospective, multicenter, single group pretest/post-test study. Psychosocial care was delivered by 29 psychosocial care teams (PSTs; 137 professionals). Pre- and post-intervention changes in these variables were assessed: mood, anxiety, and emotional distress. Patients were classified as complex, when presented with high levels of anxiety, mood, suffering (or perception of time as slow), and distress (or unease, or discomfort), or noncomplex. These groups were compared to assess changes in suffering-related parameters from baseline. Psychosocial interventions reduced patients' suffering. These interventions were more effective in complex patients. After successive psychosocial interventions, the level of suffering in complex patients decreased until close to parity with noncomplex patients, suggesting that patients with major complexity could benefit most from specific psychosocial treatment. These findings support the importance of assessing and treating patients' psychosocial needs.

Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes

PubMed Central

Baker, Richard; Camosso-Stefinovic, Janette; Gillies, Clare; Shaw, Elizabeth J; Cheater, Francine; Flottorp, Signe; Robertson, Noelle

2014-01-01

Background In the previous version of this review, the effectiveness of interventions tailored to barriers to change was found to be uncertain. Objectives To assess the effectiveness of interventions tailored to address identified barriers to change on professional practice or patient outcomes. Search methods For this update, in addition to the EPOC Register and pending files, we searched the following databases without language restrictions, from inception until August 2007: MEDLINE, EMBASE, CINAHL, BNI and HMIC. We searched the National Research Register to November 2007. We undertook further searches to October 2009 to identify potentially eligible published or ongoing trials. Selection criteria Randomised controlled trials (RCTs) of interventions tailored to address prospectively identified barriers to change that reported objectively measured professional practice or healthcare outcomes in which at least one group received an intervention designed to address prospectively identified barriers to change. Data collection and analysis Two reviewers independently assessed quality and extracted data. We undertook quantitative and qualitative analyses. The quantitative analyses had two elements. We carried out a meta-regression to compare interventions tailored to address identified barriers to change with either no interventions or an intervention(s) not tailored to the barriers.We carried out heterogeneity analyses to investigate sources of differences in the effectiveness of interventions. These included the effects of: risk of bias, concealment of allocation, rigour of barrier analysis, use of theory, complexity of interventions, and the reported presence of administrative constraints. Main results We included 26 studies comparing an intervention tailored to address identified barriers to change to no intervention or an intervention(s) not tailored to the barriers. The effect sizes of these studies varied both across and within studies. Twelve studies provided enough data to be included in the quantitative analysis. A meta-regression model was fitted adjusting for baseline odds by fitting it as a covariate, to obtain the pooled odds ratio of 1.54 (95% CI, 1.16 to 2.01) from Bayesian analysis and 1.52 (95% CI, 1.27 to 1.82, P < 0.001) from classical analysis. The heterogeneity analyses found that no study attributes investigated were significantly associated with effectiveness of the interventions. Authors’ conclusions Interventions tailored to prospectively identified barriers are more likely to improve professional practice than no intervention or dissemination of guidelines. However, the methods used to identify barriers and tailor interventions to address them need further development. Research is required to determine the effectiveness of tailored interventions in comparison with other interventions. PMID:20238340

A retrospective, nonrandomized, beforeand- after study of the effect of linens constructed of synthetic silk-like fabric on pressure ulcer incidence.

PubMed

Smith, Annette; McNichol, Laurie L; Amos, Mary Anne; Mueller, Gayle; Griffin, Tracy; Davis, Joe; McPhail, Lora; Montgomery, Terry G

2013-04-01

A new, synthetic, silk-like fabric was developed for the purpose of providing bedding and patient gowns that manage moisture, friction, and shear when used between the patient and the healthcare support surface that may affect the development of pressure ulcers (PUs). A retrospective study was conducted to compare the incidence of hospital-acquired PUs in patients admitted to Telemetry, Urology, and Intensive Care Units before and after hospital linens were changed from standard to the synthetic (intervention) linens. Patient medical record data were abstracted for a period 12 weeks before (control) and 12 weeks following the linen change (intervention). Patient demographic information, Braden Risk Scale score, and PU status and stage were abstracted for a total of 659 patients in the control and 768 patients in the intervention groups. No significant differences in patient weight, age, gender distribution, PU risk (Braden scale scores), or proportion of PUs on admission between groups were found. The most common comorbidity was hypertension (n = 981, 68.7%). On admission, the percentage of patients with PUs in the control and intervention groups was 9.9% (σ = 0.3) and 8.7% (σ = 0.3), respectively (P = 0.23). Average length of stay was 5.6 days in the control and 5.2 days in the intervention groups (P = 0.08). Sixty-eight (68) of 659 patients (10.3%) in the control and 19 out of 768 patients in the intervention group (2.5%) developed one or more PUs (P <0.001) for an incidence of 11.5% in the control and 3.1% in the intervention group. At discharge, 136 PUs were present in the control and 64 were present in the intervention group (P <0.001). The significant differences in the incidence of hospital-acquired PUs between the two groups suggest that linen type affects PU risk. Additional controlled clinical studies in high-risk patient populations are warranted.

Prevention of occupational injuries: Evidence for effective good practices in foundries.

PubMed

Porru, Stefano; Calza, Stefano; Arici, Cecilia

2017-02-01

Occupational injuries are a relevant research and practical issue. However, intervention studies evaluating the effectiveness of workplace injury prevention programs are seldom performed. The effectiveness of a multifaceted intervention aimed at reducing occupational injury rates (incidence/employment-based=IR, frequency/hours-based=FR, severity=SR) was evaluated between 2008 and 2013 in 29 Italian foundries (22 ferrous; 7 non-ferrous; 3,460 male blue collar workers/year) of varying sizes. Each foundry established an internal multidisciplinary prevention team for risk assessment, monitoring and prevention of occupational injuries, involving employers, occupational physicians, safety personnel, workers' representatives, supervisors. Targets of intervention were workers, equipment, organization, workplace, job tasks. An interrupted time series (ITS) design was applied. 4,604 occupational injuries and 83,156 lost workdays were registered between 2003 and 2013. Statistical analysis showed, after intervention, a reduction of all injury rates (-26% IR, -15% FR, -18% SR) in ferrous foundries and of SR (-4%) in non-ferrous foundries. A significant (p=0.021) 'step-effect' was shown for IR in ferrous foundries, independent of secular trends (p<0.001). Sector-specific benchmarks for all injury rates were developed separately for ferrous and non-ferrous foundries. Strengths of the study were: ITS design, according to standardized quality criteria (i.e., at least three data points before and three data points after intervention; clearly defined intervention point); pragmatic approach, with good external validity; promotion of effective good practices. Main limitations were the non-randomized nature and a medium length post-intervention period. In conclusion, a multifaceted, pragmatic and accountable intervention is effective in reducing the burden of occupational injuries in small-, medium- and large-sized foundries. Practical Applications: The study poses the basis for feasible good practice guidelines to be implemented to prevent occupational injuries, by means of sector-specific numerical benchmarks, with potentially relevant impacts on workers, companies, occupational health professionals and society at large. Copyright © 2016 National Safety Council and Elsevier Ltd. All rights reserved.

Sexual health risk reduction interventions for people with severe mental illness: a systematic review.

PubMed

Pandor, Abdullah; Kaltenthaler, Eva; Higgins, Agnes; Lorimer, Karen; Smith, Shubulade; Wylie, Kevan; Wong, Ruth

2015-02-12

Despite variability in sexual activity among people with severe mental illness, high-risk sexual behavior (e.g. unprotected intercourse, multiple partners, sex trade and illicit drug use) is common. Sexual health risk reduction interventions (such as educational and behavioral interventions, motivational exercises, counselling and service delivery), developed and implemented for people with severe mental illness, may improve participants' knowledge, attitudes, beliefs behaviors or practices (including assertiveness skills) and could lead to a reduction in risky sexual behavior. This systematic review evaluates the effectiveness of sexual health risk reduction interventions for people with severe mental illness. Thirteen electronic databases (including MEDLINE, EMBASE and PsycINFO) were searched to August 2014, and supplemented by hand-searching relevant articles and contacting experts. All controlled trials (randomized or non-randomized) comparing the effectiveness of sexual health risk reduction interventions with usual care for individuals living in the community with severe mental illness were included. Outcomes included a range of biological, behavioral and proxy endpoints. Narrative synthesis was used to combine the evidence. Thirteen controlled trials (all from the USA) were included. Although there was no clear and consistent evidence that interventions reduce the total number of sex partners or improved behavioral intentions in sexual risk behavior, positive effects were generally observed in condom use, condom protected intercourse and on measures of HIV knowledge, attitudes to condom use and sexual behaviors and practices. However, the robustness of these findings is low due to the large between study variability, small sample sizes and low-to-moderate quality of included studies. There is insufficient evidence at present to fully support or reject the identified sexual health risk reduction interventions for people with severe mental illness. Given the serious consequences of high-risk sexual behaviors, there is an urgent need for well-designed UK based trials, as well as training and support for staff implementing sexual health risk reduction interventions. PROSPERO CRD42013003674 .

Interventions to reduce consumption of sugar-sweetened beverages or increase water intake: evidence from a systematic review and meta-analysis.

PubMed

Vargas-Garcia, E J; Evans, C E L; Prestwich, A; Sykes-Muskett, B J; Hooson, J; Cade, J E

2017-11-01

A systematic review and meta-analyses were conducted to evaluate the effects of interventions to reduce sugar-sweetened beverages (SSB) or increase water intakes and to examine the impact of behaviour change techniques (BCTs) in consumption patterns. Randomized and nonrandomized controlled trials published after January 1990 and until December 2016 reporting daily changes in intakes of SSB or water in volumetric measurements (mL d -1 ) were included. References were retrieved through searches of electronic databases and quality appraisal followed Cochrane principles. We calculated mean differences (MD) and synthesized data with random-effects models. Forty studies with 16 505 participants were meta-analysed. Interventions significantly decreased consumption of SSB in children by 76 mL d -1 (95% confidence interval [CI] -105 to -46; 23 studies, P < 0.01), and in adolescents (-66 mL d -1 , 95% CI -130 to -2; 5 studies, P = 0.04) but not in adults (-13 mL d -1 , 95% CI -44 to 18; 12 studies, P = 0.16). Pooled estimates of water intakes were only possible for interventions in children, and results were indicative of increases in water intake (MD +67 mL d -1 , 95% CI 6 to 128; 7 studies, P = 0.04). For children, there was evidence to suggest that modelling/demonstrating the behaviour helped to reduce SSB intake and that interventions within the home environment had greater effects than school-based interventions. In conclusion, public health interventions - mainly via nutritional education/counselling - are moderately successful at reducing intakes of SSB and increasing water intakes in children. However, on average, only small reductions in SSBs have been achieved by interventions targeting adolescents and adults. Complementary measures may be needed to achieve greater improvements in both dietary behaviours across all age groups. © 2017 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.

Interventions to significantly improve service uptake and retention of HIV-positive pregnant women and HIV-exposed infants along the prevention of mother-to-child transmission continuum of care: systematic review.

PubMed

Vrazo, Alexandra C; Firth, Jacqueline; Amzel, Anouk; Sedillo, Rebecca; Ryan, Julia; Phelps, B Ryan

2018-02-01

Despite the success of Prevention of Mother-to-Child Transmission of HIV (PMTCT) programmes, low uptake of services and poor retention pose a formidable challenge to achieving the elimination of vertical HIV transmission in low- and middle-income countries. This systematic review summarises interventions that demonstrate statistically significant improvements in service uptake and retention of HIV-positive pregnant and breastfeeding women and their infants along the PMTCT cascade. Databases were systematically searched for peer-reviewed studies. Outcomes of interest included uptake of services, such as antiretroviral therapy (ART) such as initiation, early infant diagnostic testing, and retention of HIV-positive pregnant and breastfeeding women and their infants. Interventions that led to statistically significant outcomes were included and mapped to the PMTCT cascade. An eight-item assessment tool assessed study rigour. CRD42017063816. Of 686 citations reviewed, 11 articles met inclusion criteria. Ten studies detailed maternal outcomes and seven studies detailed infant outcomes in PMTCT programmes. Interventions to increase access to antenatal care (ANC) and ART services (n = 4) and those using lay cadres (n = 3) were most common. Other interventions included quality improvement (n = 2), mHealth (n = 1), and counselling (n = 1). One study described interventions in an Option B+ programme. Limitations included lack of HIV testing and counselling and viral load monitoring outcomes, small sample size, geographical location, and non-randomized assignment and selection of participants. Interventions including ANC/ART integration, family-centred approaches, and the use of lay healthcare providers are demonstrably effective in increasing service uptake and retention of HIV-positive mothers and their infants in PMTCT programmes. Future studies should include control groups and assess whether interventions developed in the context of earlier 'Options' are effective in improving outcomes in Option B+ programmes. © 2017 John Wiley & Sons Ltd.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Designing and evaluating a web-based self-management site for patients with type 2 diabetes--systematic website development and study protocol.

PubMed

Yu, Catherine H; Parsons, Janet; Mamdani, Muhammad; Lebovic, Gerald; Shah, Baiju R; Bhattacharyya, Onil; Laupacis, Andreas; Straus, Sharon E

2012-06-24

Given that patients provide the majority of their own diabetes care, patient self-management training has increasingly become recognized as an important strategy with which to improve quality of care. However, participation in self management programs is low. In addition, the efficacy of current behavioural interventions wanes over time, reducing the impact of self-management interventions on patient health. Web-based interventions have the potential to bridge the gaps in diabetes care and self-management. Our objective is to improve self-efficacy, quality of life, self-care, blood pressure, cholesterol and glycemic control and promote exercise in people with type 2 diabetes through the rigorous development and use of a web-based patient self-management intervention. This study consists of five phases: (1) intervention development; (2) feasibility testing; (3) usability testing; (4) intervention refinement; and (5) intervention evaluation using mixed methods. We will employ evidence-based strategies and tools, using a theoretical framework of self-efficacy, then elicit user feedback through focus groups and individual user testing sessions. Using iterative redesign the intervention will be refined. Once finalized, the impact of the website on patient self-efficacy, quality of life, self-care, HbA1c, LDL-cholesterol, blood pressure and weight will be assessed through a non-randomized observational cohort study using repeated measures modeling and individual interviews. Increasing use of the World Wide Web by consumers for health information and ongoing revolutions in social media are strong indicators that users are primed to welcome a new era of technology in health care. However, their full potential is hindered by limited knowledge regarding their effectiveness, poor usability, and high attrition rates. Our development and research agenda aims to address these limitations by improving usability, identifying characteristics associated with website use and attrition, and developing strategies to sustain patient use in order to maximize clinical outcomes.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

Low-Impact Flooring: Does It Reduce Fall-Related Injuries?

PubMed

Hanger, H Carl

2017-07-01

To compare fall rates and injuries from falls on low-impact flooring (LIF) compared with a standard vinyl flooring. Prospective, observational, nonrandomized controlled study. Subacute Older Persons Health ward (N = 20 beds). Older inpatients. Three different types of LIF. All falls in the ward were prospectively monitored using incident reporting, noting location and consequences of each fall. Fall rates (per 1000 bed days) and injuries, were compared between bedroom falls on LIF against those occurring on standard vinyl flooring (controls). Over 31 months, there were 278 bedroom falls (from 178 fallers). The bedroom fall rate (falls per 1000 bed days occupied) did not differ between the LIF and control groups (median 15 [IQR 8-18] versus 17 [IQR 9-23], respectively; P = .47). However, fall-related injuries were significantly less frequent when they occurred on LIFs (22% of falls versus 34% of falls on control flooring; P = .02). Fractures occurred in 0.7% of falls in the LIF cohort versus 2.3% in the control cohort. Rolling resistance when moving heavier equipment, such as beds or hoists, was an issue for staff on LIF. LIF significantly reduced fall-related injuries compared with a standard vinyl flooring, whereas they did not alter the overall risk of falling. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

PubMed

Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

2014-01-01

Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

PubMed Central

Hauptmann, Christian; Ströbel, Armin; Williams, Mark; Patel, Nitesh; Wurzer, Hannes; von Stackelberg, Tatjana; Brinkmann, Uwe; Langguth, Berthold; Tass, Peter A.

2015-01-01

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study. Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder). Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy. Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting. PMID:26568958

The use of a virtual reality surgical simulator for cataract surgical skill assessment with 6 months of intervening operating room experience.

PubMed

Sikder, Shameema; Luo, Jia; Banerjee, P Pat; Luciano, Cristian; Kania, Patrick; Song, Jonathan C; Kahtani, Eman S; Edward, Deepak P; Towerki, Abdul-Elah Al

2015-01-01

To evaluate a haptic-based simulator, MicroVisTouch™, as an assessment tool for capsulorhexis performance in cataract surgery. The study is a prospective, unmasked, nonrandomized dual academic institution study conducted at the Wilmer Eye Institute at Johns Hopkins Medical Center (Baltimore, MD, USA) and King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). This prospective study evaluated capsulorhexis simulator performance in 78 ophthalmology residents in the US and Saudi Arabia in the first round of testing and 40 residents in a second round for follow-up. Four variables (circularity, accuracy, fluency, and overall) were tested by the simulator and graded on a 0-100 scale. Circularity (42%), accuracy (55%), and fluency (3%) were compiled to give an overall score. Capsulorhexis performance was retested in the original cohort 6 months after baseline assessment. Average scores in all measured metrics demonstrated statistically significant improvement (except for circularity, which trended toward improvement) after baseline assessment. A reduction in standard deviation and improvement in process capability indices over the 6-month period was also observed. An interval objective improvement in capsulorhexis skill on a haptic-enabled cataract surgery simulator was associated with intervening operating room experience. Further work investigating the role of formalized simulator training programs requiring independent simulator use must be studied to determine its usefulness as an evaluation tool.

Pharyngocutaneous fistulae following total laryngectomy comparison between manual and mechanical sutures.

PubMed

Gonçalves, Antonio José; de Souza, J A L; Menezes, M B; Kavabata, N K; Suehara, A B; Lehn, C N

2009-11-01

The extension of the surgery and closure type of the pharynx can be the determinants in the pharyngocutaneous fistula development. The objective of the study is to evaluate the incidence of pharingocutaneous salivary fistulae after total laryngectomies comparing manual and mechanical sutures. The study is designed as non-randomized, prospective clinical study. Sixty patients with squamous cell carcinoma were submitted to total laryngectomies. In 30 cases, the linear stapler (75 mm) closure (surgical technique described in details) and in other 30 cases manual suture was used. The cases of mechanical suture were prospective and consecutive and the cases of manual suture were a review series of patients who underwent a manual suture of pharynx, in the same period of time. The statistical analysis between the two groups concluded that both were comparable. Fistulae incidence was 6.7% (2/30) in the group with the mechanical suture and 36.7% (11/30) in the group with manual suture closure, presenting a significant difference (p = 0.0047). The total laryngectomy with mechanical closure is an easy and fast learning technique, allowing watertight closure of the pharynx with a low risk of contamination of the surgical field. It is an assured method, even in previously irradiated patients, since we respect the limits of its indication regarding the extension of primary tumor that must be confirmed by previous suspension laryngectomy performed in the operating room.

Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

PubMed

Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

2017-05-01

To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes.

PubMed

Anhøj, Jacob; Olesen, Anne Vingaard

2014-01-01

A run chart is a line graph of a measure plotted over time with the median as a horizontal line. The main purpose of the run chart is to identify process improvement or degradation, which may be detected by statistical tests for non-random patterns in the data sequence. We studied the sensitivity to shifts and linear drifts in simulated processes using the shift, crossings and trend rules for detecting non-random variation in run charts. The shift and crossings rules are effective in detecting shifts and drifts in process centre over time while keeping the false signal rate constant around 5% and independent of the number of data points in the chart. The trend rule is virtually useless for detection of linear drift over time, the purpose it was intended for.

Genetic View on the Phenomenon of Combined Diseases in Man

PubMed Central

Freidin, M.B.

2009-01-01

In clinical medicine, the phenomenon of polypathy, as a particular object of investigation, was first put forth by French clinicians at the end of the 19th century through the "arthritismus" doctrine. In the first half of the 20th century, German paediatricians singled out "syntropias," which are combinations of diseases with common pathophysiological mechanisms, and "dystropias," which are diseases that rarely co-occur in one individual. In the present paper, syntropy/dystropy is defined as a natural generic nonrandom phenomenon with an evolutionary-genetic basis. The genes involved in the development of syntropy are called "syntropic genes," whereas the genes that co-participate in pathophysiological mechanisms and prevent the co-occurrence of particular phenotypes are called "dystropic genes." Prospects for studying the genetic basis of this phenomenon are highlighted. The publicly available database HuGENet can be used in order to identify syntropic genes, as will be shown as examples in an analysis of cardiovascular diseases. PMID:22649614

Prospective Measurement of Daily Health Behaviors: Modeling Temporal Patterns in Missing Data, Sexual Behavior, and Substance Use in an Online Daily Diary Study of Gay and Bisexual Men.

PubMed

Rendina, H Jonathon; Ventuneac, Ana; Mustanski, Brian; Grov, Christian; Parsons, Jeffrey T

2016-08-01

Daily diary and other intensive longitudinal methods are increasingly being used to investigate fluctuations in psychological and behavioral processes. To inform the development of this methodology, we sought to explore predictors of and patterns in diary compliance and behavioral reports. We used multilevel modeling to analyze data from an online daily diary study of 371 gay and bisexual men focused on sexual behavior and substance use. We found that greater education and older age as well as lower frequency of substance use were associated with higher compliance. Using polynomial and trigonometric functions, we found evidence for circaseptan patterns in compliance, sexual behavior, and substance use, as well as linear declines in compliance and behavior over time. The results suggest potential sources of non-random patterns of missing data and suggest that trigonometric terms provide a similar but more parsimonious investigation of circaseptan rhythms than do third-order polynomial terms.

Prospective Measurement of Daily Health Behaviors: Modeling Temporal Patterns in Missing Data, Sexual Behavior, and Substance Use in an Online Daily Diary Study of Gay and Bisexual Men

PubMed Central

Rendina, H. Jonathon; Ventuneac, Ana; Mustanski, Brian; Grov, Christian; Parsons, Jeffrey T.

2016-01-01

Daily diary and other intensive longitudinal methods are increasingly being used to investigate fluctuations in psychological and behavioral processes. To inform the development of this methodology, we sought to explore predictors of and patterns in diary compliance and behavioral reports. We used multilevel modeling to analyze data from an online daily diary study of 371 gay and bisexual men focused on sexual behavior and substance use. We found that greater education and older age as well as lower frequency of substance use were associated with higher compliance. Using polynomial and trigonometric functions, we found evidence for circaseptan patterns in compliance, sexual behavior, and substance use, as well as linear declines in compliance and behavior over time. The results suggest potential sources of non-random patterns of missing data and suggest that trigonometric terms provide a similar but more parsimonious investigation of circaseptan rhythms than do third-order polynomial terms. PMID:26992392

Anal Cancer: An Examination of Radiotherapy Strategies

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

Glynne-Jones, Rob; Lim, Faye

2011-04-01

The Radiation Therapy Oncology Group 9811, ACCORD-03, and ACT II Phase III trials in anal cancer showed no benefit for cisplatin-based induction and maintenance chemotherapy, or radiation dose-escalation >59 Gy. This review examines the efficacy and toxicity of chemoradiation (CRT) in anal cancer, and discusses potential alternative radiotherapy strategies. The evidence for the review was compiled from randomized and nonrandomized trials of radiation therapy and CRT. A total of 103 retrospective/observational studies, 4 Phase I/II studies, 16 Phase II prospective studies, 2 randomized Phase II studies, and 6 Phase III trials of radiotherapy or chemoradiation were identified. There are nomore » meta-analyses based on individual patient data. A 'one-size-fits-all' approach for all stages of anal cancer is inappropriate. Early T1 tumors are probably currently overtreated, whereas T3/T4 lesions might merit escalation of treatment. Intensity-modulated radiotherapy or the integration of biological therapy may play a role in future.« less

Efficacy of a Culturally Tailored Therapeutic Intervention Program for Community Dwelling Depressed Korean American Women: A Non-Randomized Quasi-Experimental Design Study.

PubMed

Bernstein, Kunsook; Park, So-Young; Hahm, Sohee; Lee, Young Na; Seo, Jin Young; Nokes, Kathleen M

2016-02-01

Asian American women are more prone to suffer from depression compared to their non-Asian American counterparts and have lower rates of seeking mental healthcare services due to lack of available culturally appropriate therapies. Two prior studies of a culturally tailored therapeutic intervention called LogoAutobiography were helpful in treating depressed Korean American women. The LogoAutobiography program was revised to enhance its efficacy not only for depressive symptoms and purpose in life but also to increase coping strategies. To test the efficacy of the Enhanced LogoAutobiography program on depressive symptoms, purpose in life, and coping strategies of depressed community-dwelling Korean American women. Two-group, non-randomized quasi-experimental design. Local Korean community areas located in New York City and eastern New Jersey of the United States. A total of 54 depressed women with Korean heritage completed either experimental group (n1=25) or control group (n2=29). Sample inclusion criteria were adult women with Korean heritage, depressive symptoms as measured by a CES-D score 16 or higher, fluent Korean language, and able to participate independently. Sample exclusion criteria were those who presented active suicidal ideation and history of episodes of mania or psychosis screened by the psychosocial survey questionnaire. The experimental group received Enhanced Logo-Autobiography program which was guided by a facilitator who used a manualized intervention for 90minute sessions over 8weeks; the control group attended routine weekly community activities. Data were collected during the first session (pretest), the end of 8weeks (posttest), and the 3months follow-up session. Time and group changes in depressive symptoms, purpose in life, and coping strategies were computed using Repeated Measures General Linear Model (RMGLM). Findings suggested that the experimental group showed greater improvement in depressive symptoms (F=6.94 (2, 88), p<0.01), active cognitive coping (F=5.07 (2, 86), p<0.01), and avoidance coping strategies (F=3.48 (2, 86), p<0.05) compared to the control group during the three time intervals. Purpose in life showed statistically significant Time and Group effects (F=5.18 (2, 88), p<0.01; F=9.44 (2, 88), p<0.01, respectively), but no significant interaction effect of Time and Group was detected. These findings suggest that enhanced LogoAutobiography is effective for depressive symptoms and coping strategies and somewhat effective for improving purpose in life for depressed Korean American women. Copyright © 2015 Elsevier Inc. All rights reserved.

Efficacy of a Culturally Tailored Therapeutic Intervention Program for Community Dwelling Depressed Korean American Women: A Non-Randomized Quasi-Experimental Design Study

PubMed Central

Bernstein, Kunsook; Park, So-Young; Hahm, Sohee; Lee, Young Na; Seo, Jin Young; Nokes, Kathleen M.

2016-01-01

Background Asian American women are more prone to suffer with depression compared to their non-Asian American counterparts and have lower rates of seeking mental healthcare services due to lack of available culturally appropriate therapies. Two prior studies of a culturally tailored therapeutic intervention called LogoAutobiography were helpful in treating depressed Korean American women. The LogoAutobiography program was revised to enhance its efficacy not only for depressive symptoms and purpose in life but also to increase coping strategies. Objectives To test the efficacy of the Enhanced LogoAutobiography program on depressive symptoms, purpose in life, and coping strategies of depressed community-dwelling Korean American women. Design Two-group, non-randomized quasi-experimental design. Settings Local Korean community areas located in New York City and eastern New Jersey of the United States. Participants A total of 54 depressed women with Korean heritage completed either experimental group (n1= 25) or control group (n2= 29). Sample inclusion criteria were adult women with Korean heritage, depressive symptoms as measured by a CES-D score 16 or higher, fluent Korean language, and able to participate independently. Sample exclusion criteria were those who presented active suicidal ideation and history of episodes of mania or psychosis screened by the psychosocial survey questionnaire. Methods The experimental group received Enhanced Logo-Autobiography program which was guided by a facilitator who used a manualized intervention for 90 minute sessions over 8 weeks; the control group attended routine weekly community activities. Data were collected during the first session (pretest), the end of 8 weeks (posttest), and the 3 months follow-up session. Time and group changes in depressive symptoms, purpose in life, and coping strategies were computed using Repeated Measures General Linear Model (RMGLM). Results Findings suggested that the experimental group showed greater improvement in depressive symptoms (F = 6.94 (2, 88), p < 0.01), active cognitive coping (F = 5.07 (2, 86), p < 0.01), and avoidance coping strategies (F = 3.48 (2, 86), p < 0.05) compared to the control group during the three time intervals. Purpose in life showed statistically significant Time and Group effects (F = 5.18 (2, 88), p < 0.01; F = 9.44 (2, 88), p < 0.01, respectively), but no significant interaction effect of Time and Group was detected. Conclusion These findings suggest that enhanced LogoAutobiography is effective for depressive symptoms and coping strategies and somewhat effective for improving purpose in life for depressed Korean American women. PMID:26804497

Long-term results of a non-ramdomized prospective mono-centre study of 1000 laparoscopic totally extraperitoneal hernia repairs.

PubMed

Thill, V; Simoens, C; Smets, D; Ngongang, C; da Costa, P Mendes

2008-01-01

Information concerning short-term results for laparoscopic extraperitoneal hernia repair is available, but long-term results remain poorly documented. The purpose of this non-randomized prospective study was to evaluate recurrence and chronic pain after hernia repair over a period longer than 10 years. From 1995 to 2004, all patients aged 30 years or more, manifesting with inguinal hernia, were included in our study. Patients aged 20 to 30 years presenting with bilateral hernia, recurrent hernia, or who were heavy workers were also included. Patients who had pelvic irradiation, strangulated hernia, prostatic cancer resection, or a contra-indication to general anaesthesia were excluded. Of 1096 hernia repairs performed, 248 patients were excluded and underwent open repair and 848 patients (77.4%) were included in our prospective study, which corresponded to 1000 laparoscopic hernia repairs. The sex ratio (male : female) was 5:8, and the average age was 56 years. Seven hundred and fifty-three hernias (75.3%) were first repairs, 247 (24.7%) were recurrent hernias, and 161 were bilateral hernias. There were no mortalities. The conversion rate was 1.1%, and the global postoperative morbidity rate was 10.3%. Average follow-up was 39 months in 92.2% of the patients. Hernia recurrence rate was 1.5%. Chronic pain occurred in 2.9%. During this follow-up, 22 contra-lateral hernias appeared in those patients who initially had unilateral hernia repair (3.2%). All of these contra-lateral hernias could be successfully treated using a laparoscopic total extraperitoneal approach. The long-term results of this study demonstrate that preperitoneal laparoscopic hernia repair is a safe technique with a very low recurrence rate and low prevalence of chronic pain.

REDUCING SUICIDAL IDEATION AND DEPRESSION IN OLDER PRIMARY CARE PATIENTS: 24-MONTH OUTCOMES OF THE PROSPECT STUDY

PubMed Central

Alexopoulos, George S.; Reynolds, Charles F.; Bruce, Martha L.; Katz, Ira R.; Raue, Patrick J.; Mulsant, Benoit H.; Oslin, David; Have, Thomas Ten

2010-01-01

Objective The PROSPECT Study evaluated the impact of a care management intervention on suicidal ideation and depression in older primary care patients. This is the first report of outcomes over a 2-year period. Method The subjects (N=599) were older (>=60 years) patients with major or minor depression selected after screening 9,072 randomly identified patients of 20 primary care practices randomly assigned to the PROSPECT intervention or usual care. The intervention consisted of services of 15 trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 24 months. Results Intervention patients had a higher likelihood to receive antidepressants and or psychotherapy (84.9–89% vs. 49–59%) and a 2.2 times greater decline in suicidal ideation than usual care patients over 24 months. Treatment response occurred earlier in intervention patients and continued to increase from the 18th to the 24th month, while there was no appreciable increase in usual care patients during the same period. Among patients with major depression, a greater number achieved remission in the intervention than the usual care group at 4 (26.6 vs. 15.2%), 8 (36% vs. 22.5%), and 24 (45.4% vs. 31.5%) months. Patients with minor depression had favorable outcomes regardless of treatment assignment. Conclusions Sustained collaborative care maintains high utilization of antidepressant treatment, reduces suicidal ideation, and improves the outcomes of major depression over two years. These observations suggest that sustained collaborative care increases depression-free days. PMID:19528195