Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

ERIC Educational Resources Information Center

Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

2016-01-01

In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

The role of prophylactic internal iliac artery ligation in abnormally invasive placenta undergoing caesarean hysterectomy: a randomized control trial.

PubMed

Hussein, Ahmed M; Dakhly, Dina Mohamed Refaat; Raslan, Ayman N; Kamel, Ahmed; Abdel Hafeez, Ali; Moussa, Manal; Hosny, Ahmed Samir; Momtaz, Mohamed

2018-04-25

To identify the role of bilateral internal iliac artery (IIA) ligation on reducing blood loss in abnormally invasive placenta (AIP) undergoing caesarean hysterectomy. In this parallel-randomized control trial, 57 pregnant females with ultrasound features suggestive of AIP were enrolled. They were randomized into two groups; IIA group (n = 29 cases) performed bilateral IIA ligation followed by caesarean hysterectomies, while Control group (n = 28 cases) underwent caesarean hysterectomy only. The main outcome was the difference in the estimated intraoperative blood loss between the two groups. There was no significant difference between the two groups regarding the intraoperative estimated blood loss (1632 ± 804 versus 1698 ± 1251, p value .83). The operative procedure duration (minutes) (223 ± 66 versus 171 ± 41.4, p value .001) varied significantly between the two groups. Bilateral internal iliac artery ligation, in cases of AIP undergoing caesarean hysterectomy, is not recommended for routine practice to minimize blood loss intraoperatively.

Impact of random and systematic recall errors and selection bias in case--control studies on mobile phone use and brain tumors in adolescents (CEFALO study).

PubMed

Aydin, Denis; Feychting, Maria; Schüz, Joachim; Andersen, Tina Veje; Poulsen, Aslak Harbo; Prochazka, Michaela; Klaeboe, Lars; Kuehni, Claudia E; Tynes, Tore; Röösli, Martin

2011-07-01

Whether the use of mobile phones is a risk factor for brain tumors in adolescents is currently being studied. Case--control studies investigating this possible relationship are prone to recall error and selection bias. We assessed the potential impact of random and systematic recall error and selection bias on odds ratios (ORs) by performing simulations based on real data from an ongoing case--control study of mobile phones and brain tumor risk in children and adolescents (CEFALO study). Simulations were conducted for two mobile phone exposure categories: regular and heavy use. Our choice of levels of recall error was guided by a validation study that compared objective network operator data with the self-reported amount of mobile phone use in CEFALO. In our validation study, cases overestimated their number of calls by 9% on average and controls by 34%. Cases also overestimated their duration of calls by 52% on average and controls by 163%. The participation rates in CEFALO were 83% for cases and 71% for controls. In a variety of scenarios, the combined impact of recall error and selection bias on the estimated ORs was complex. These simulations are useful for the interpretation of previous case-control studies on brain tumor and mobile phone use in adults as well as for the interpretation of future studies on adolescents. Copyright © 2011 Wiley-Liss, Inc.

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

Chopped random-basis quantum optimization

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

Caneva, Tommaso; Calarco, Tommaso; Montangero, Simone

2011-08-15

In this work, we describe in detail the chopped random basis (CRAB) optimal control technique recently introduced to optimize time-dependent density matrix renormalization group simulations [P. Doria, T. Calarco, and S. Montangero, Phys. Rev. Lett. 106, 190501 (2011)]. Here, we study the efficiency of this control technique in optimizing different quantum processes and we show that in the considered cases we obtain results equivalent to those obtained via different optimal control methods while using less resources. We propose the CRAB optimization as a general and versatile optimal control technique.

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Association between biomass fuel and pulmonary tuberculosis: a nested case-control study.

PubMed

Kolappan, C; Subramani, R

2009-08-01

To quantify the association between biomass fuel usage and sputum-positive pulmonary tuberculosis. A tuberculosis prevalence survey was conducted in a random sample of 50 rural units (villages) and three urban units in the Tiruvallur district of Tamilnadu, India during the period 2001-2003. Additional data regarding exposure to tobacco smoking, alcohol consumption, biomass fuel usage and Standard of Living Index (SLI) were also collected from the study participants. A nested case-control study was carried out in this population. Cases are defined as bacteriological-positive cases diagnosed by either sputum smear or culture examination. For each case, five age- (within +/-5 years of age) and sex-matched controls were selected randomly from the non-cases residing in the same village/unit. Thus, 255 cases and 1275 controls were included in this study. The unadjusted OR measured from univariate analysis for biomass fuel is 2.9 (95% CI 1.8 to 4.7). The adjusted OR measured from multivariate analysis using Cox regression is 1.7 (95% CI 1.0 to 2.9). Thirty-six percent of cases are attributable to biomass fuel usage. The findings from this case-control study add to the evidence for an independent association between biomass smoke and pulmonary tuberculosis. Improvement in standards of living brought about by economic development will lead to more people using cleaner fuels for cooking than biomass fuel which in turn will lead to a reduction in the occurrence of pulmonary tuberculosis in the community.

Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

PubMed

Blencowe, Natalie S; Cook, Jonathan A; Pinkney, Thomas; Rogers, Chris; Reeves, Barnaby C; Blazeby, Jane M

2017-04-01

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

Xuebijing in the treatment of patients with sepsis.

PubMed

Shi, Heng; Hong, Yun; Qian, Jianfang; Cai, Xiaofang; Chen, Shanwen

2017-02-01

There are more than 18 million patients diagnosed with sepsis every year. In China, Xuebijing (XBJ) injection is a traditional medicine that is widely used in the treatment of sepsis. However, the efficacy of XBJ in treatment of randomized controlled trials (RCTs) remains unclear. This meta-analysis was to evaluate the clinical efficacy of XBJ based on randomized case-control studies. PubMed, Cochrane, Embase, Wanfang, CNKI, and WeiPu (VIP) databases were searched to identify all the relative randomized case-control. The latest research was done in June, 2016. Relative risks (RR), weighted mean difference (WMD) along with 95% confidence interval (95%CI) were used to analyze the main outcomes. Statistical analysis was performed using STATA 10.0 (TX, USA). The qualities of the involved articles were accessed by the Jadad scale. Forty-nine randomized case-control studies met the inclusion and exclusion criteria, with 1861 patients in the control group and 2023 patients in the XBJ group. Compared with the conventional therapy, XBJ injection could significantly reduce the APACHE-IIscore (WMD: -3.70, 95%CI: -4.31-[-3.09]), PCT (WMD: -1.26μg/L, 95%CI: -1.63μg/L-[-0.88μg/L]), WBC (WMD: -1.48×10 9 /L, 95%CI: -2.03×10 9 /L-[-0.94×10 9 /L]), CRP (WMD: -24.38mg/L, 95%CI:-30.49mg/L-[-18.26mg/L]), NEU (WMD: -4.68, 95%CI: -8.32-[-1.04]), T 0 (WMD: -0.50, 95%CI: -0.92-[-0.07]). The 28-day mortality of the XBJ group was significantly lower than the control group (RR: 0.51; 95%CI: 0.44-0.59). XBJ injection has a significant clinical efficacy in the therapy of patients with sepsis. However, there is a need for more randomized, lager-sample size, high-quality, and multicenter studies to confirm the extract efficacy of XBJ injection. Copyright © 2016 Elsevier Inc. All rights reserved.

A Randomized Controlled Trial of Consensus-Based Child Abuse Case Management

ERIC Educational Resources Information Center

Goldbeck, L.; Laib-Koehnemund, A.; Fegert, J. M.

2007-01-01

Objective: This study evaluates the effects of expert-assisted child abuse and neglect case management in the German child welfare and healthcare system as perceived by the case workers themselves. Methods: Case workers with different professions (social workers, counselors, clinic-based and office-based psychotherapists, and physicians)…

Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

PubMed

Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

2012-06-01

Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

Validation of self-reported start year of mobile phone use in a Swedish case-control study on radiofrequency fields and acoustic neuroma risk.

PubMed

Pettersson, David; Bottai, Matteo; Mathiesen, Tiit; Prochazka, Michaela; Feychting, Maria

2015-01-01

The possible effect of radiofrequency exposure from mobile phones on tumor risk has been studied since the late 1990s. Yet, empirical information about recall of the start of mobile phone use among adult cases and controls has never been reported. Limited knowledge about recall errors hampers interpretations of the epidemiological evidence. We used network operator data to validate the self-reported start year of mobile phone use in a case-control study of mobile phone use and acoustic neuroma risk. The answers of 96 (29%) cases and 111 (22%) controls could be included in the validation. The larger proportion of cases reflects a more complete and detailed reporting of subscription history. Misclassification was substantial, with large random errors, small systematic errors, and no significant differences between cases and controls. The average difference between self-reported and operator start year was -0.62 (95% confidence interval: -1.42, 0.17) years for cases and -0.71 (-1.50, 0.07) years for controls, standard deviations were 3.92 and 4.17 years, respectively. Agreement between self-reported and operator-recorded data categorized into short, intermediate and long-term use was moderate (kappa statistic: 0.42). Should an association exist, dilution of risk estimates and distortion of exposure-response patterns for time since first mobile phone use could result from the large random errors in self-reported start year. Retrospective collection of operator data likely leads to a selection of "good reporters", with a higher proportion of cases. Thus, differential recall cannot be entirely excluded.

Comparison of the effectiveness of two styles of case-based learning implemented in lectures for developing nursing students' critical thinking ability: A randomized controlled trial.

PubMed

Hong, Shaohua; Yu, Ping

2017-03-01

To explore and compare the effectiveness of two styles of case-based learning methods, unfolding nursing case and usual nursing case, implemented in lectures for developing nursing students' critical thinking ability. 122 undergraduate nursing students in four classes were taught the subject of medical nursing for one year. Two classes were randomly assigned as the experimental group and the other two the control group. The experimental group received the lectures presenting unfolding nursing cases and the control group was taught the usual cases. Nineteen case-based lectures were provided in 8 months in two semesters to each group. The two groups started with a similar level of critical thinking ability as tested by the instrument of Critical Thinking Disposition Inventory-Chinese version (CTDI-CV). After receiving 19 case-based learning lectures for 8 months, both groups of students significantly improved their critical thinking ability. The improvement in the experimental group was significantly higher than that in the control group (with the average total score of 303.77±15.24 vs. 288.34±13.94, p<0.05). The experimental group also had significantly better improvement in six out of seven dimensions whereas the control group showed improvement in only three out of seven dimensions of CTDI-CV. The study suggests the feasibility of implementing case-based learning in lectures. Unfolding nursing cases appear to be significantly more effective than the usual nursing cases in developing undergraduate nursing students' critical thinking ability in the subject of medical nursing. Further research can implement the unfolding nursing cases in other nursing subjects. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Case Control Study of Suicide and Attempted Suicide in Older Adults.

ERIC Educational Resources Information Center

Beautrais, Annette L.

2002-01-01

Risk factors for serious suicidal behavior among older adults were examined in a case control study of adults aged 55 and older who died by suicide or made suicide attempts and who were compared with randomly selected comparison subjects. Multivariate analyses suggested that mood disorders were the most significant risk factor for suicidal…

[Randomized controlled study: Sophora flavescens gel in treatment of cervical HPV infection].

PubMed

Zhao, Hong-da; Feng, Xiao-Ling; Zhao, Yan; Li, Na

2016-11-01

This study aimed to evaluate the efficacy of Sophora flavescens gel in treatment of cervical HPV infection. 120 patients with cervical HPV infections were selected from department of gynecology, the first affiliated hospital, Heilongjiang university of Chinese medicine. They were randomly divided into three groups: test group(S. flavescens gel, 40 cases), control group(human recombinant interferon α-2b gel, 40 cases) and combined application group(combination of the above two, 40 cases). The treatment course was three months in all three groups. Before and after treatment, the changes of HPV viral load and the changes of viral load for different HPV types were observed.The results could provide guidance for clinical application of S. flavescens gel. Copyright© by the Chinese Pharmaceutical Association.

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial.

PubMed

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia.

Electrostatic precipitation is a novel way of maintaining visual field clarity during laparoscopic surgery: a prospective double-blind randomized controlled pilot study.

PubMed

Ansell, James; Warren, Neil; Wall, Pete; Cocks, Kim; Goddard, Stuart; Whiston, Richard; Stechman, Michael; Scott-Coombes, David; Torkington, Jared

2014-07-01

Ultravision™ is a new device that utilizes electrostatic precipitation to clear surgical smoke. The aim was to evaluate its performance during laparoscopic cholecystectomy. Patients undergoing laparoscopic cholecystectomy were randomized into "active (device on)" or "control (device off)." Three operating surgeons scored the percentage effective visibility and three reviewers scored the percentage of the procedure where smoke was present. All assessors also used a 5-point scale (1 = imperceptible/excellent and 5 = very annoying/bad) to rate visual impairment. Secondary outcomes were the number of smoke-related pauses, camera cleaning, and pneumoperitoneum reductions. Mean results are presented with 95% confidence intervals (CI). In 30 patients (active 13, control 17), the effective visibility was 89.2% (83.3-95.0) for active cases and 71.2% (65.7-76.7) for controls. The proportion of the procedure where smoke was present was 41.1% (33.8-48.3) for active cases and 61.5% (49.0-74.1) for controls. Operating surgeons rated the visual impairment as 2.2 (1.7-2.6) for active cases and 3.2 (2.8-3.5) for controls. Reviewers rated the visual impairment as 2.3 (2.0-2.5) for active cases and 3.2 (2.8-3.7) for controls. In the active group, 23% of procedures were paused to allow smoke clearance compared to 94% of control cases. Camera cleaning was not needed in 85% of active procedures and 35% of controls. The pneumoperitoneum was reduced in 0% of active cases and 88% of controls. Ultravision™ improves visibility during laparoscopic surgery and reduces delays in surgery for smoke clearance and camera cleaning.

Case-based Learning Outperformed Simulation Exercises in Disaster Preparedness Education Among Nursing Trainees in India: A Randomized Controlled Trial.

PubMed

Aluisio, Adam R; Daniel, Pia; Grock, Andrew; Freedman, Joseph; Singh, Ajai; Papanagnou, Dimitrios; Arquilla, Bonnie

2016-10-01

In resource-constrained environments, appropriately employing triage in disaster situations is crucial. Although both case-based learning (CBL) and simulation exercises (SEs) commonly are utilized in teaching disaster preparedness to adult learners, there is no substantial evidence supporting one as a more efficacious methodology. This randomized controlled trial (RCT) evaluated the effectiveness of CBL versus SEs in addition to standard didactic instruction in knowledge attainment pertaining to disaster triage preparedness. This RCT was performed during a one-day disaster preparedness course in Lucknow, India during October 2014. Following provision of informed consent, nursing trainees were randomized to knowledge assessment after didactic teaching (control group); didactic plus CBL (Intervention Group 1); or didactic plus SE (Intervention Group 2). The educational curriculum used the topical focus of triage processes during disaster situations. Cases for the educational intervention sessions were scripted, identical between modalities, and employed structured debriefing. Trained live actors were used for SEs. After primary assessment, the groups underwent crossover to take part in the alternative educational modality and were re-assessed. Two standardized multiple-choice question batteries, encompassing key core content, were used for assessments. A sample size of 48 participants was calculated to detect a ≥20% change in mean knowledge score (α=0.05; power=80%). Robustness of randomization was evaluated using X 2, anova, and t-tests. Mean knowledge attainment scores were compared using one- and two-sample t-tests for intergroup and intragroup analyses, respectively. Among 60 enrolled participants, 88.3% completed follow-up. No significant differences in participant characteristics existed between randomization arms. Mean baseline knowledge score in the control group was 43.8% (standard deviation=11.0%). Case-based learning training resulted in a significant increase in relative knowledge scores at 20.8% (P=0.003) and 10.3% (P=.033) in intergroup and intragroup analyses, respectively. As compared to control, SEs did not significantly alter knowledge attainment scores with an average score increase of 6.6% (P=.396). In crossover intra-arm analysis, SEs were found to result in a 26.0% decrement in mean assessment score (P < .001). Among nursing trainees assessed in this RCT, the CBL modality was superior to SEs in short-term disaster preparedness educational translation. Simulation exercises resulted in no detectable improvement in knowledge attainment in this population, suggesting that CBL may be utilized preferentially for adult learners in similar disaster training settings. Aluisio AR , Daniel P , Grock A , Freedman J , Singh A , Papanagnou D , Arquilla B . Case-based learning outperformed simulation exercises in disaster preparedness education among nursing trainees in India: a randomized controlled trial. Prehosp Disaster Med. 2016;31(5):516-523.

Pre-operative rectal indomethacin for reduction of postoperative nausea and vomiting after laparoscopic cholecystectomy: a double-blind randomized clinical trial.

PubMed

Pazouki, Abdolreza; Cheraghali, Roozbeh; Saeedimotahhar, Hossein; Jesmi, Fatemeh; Jangjoo, Ali; Pishgahroudsari, Mohadeseh

2015-01-01

To evaluate the effect of pre-operative indomethacin suppository on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. A double blind placebo-controlled randomized clinical trial. Hazrat Rasoul Akram Hospital, Tehran, Iran, from February 2010 to September 2012. One hundred and thirty patients, scheduled for laparoscopic cholecystectomy, were randomly divided into case and control groups. Sixty-five patients received indomethacin suppository and 70 patients received rectal placebo in the case and control groups respectively. All patients underwent the same protocol in laparoscopic surgery and anesthesia, then nausea and vomiting was recorded after 1, 6, 12 and 24 hours postoperatively and compared between the two groups. Independent-sample t test or Mann-Whitney tests were used for statistical analysis. Level of statistical significance was set at P ² 0.05. Patients' nausea was statistically lower in the case group at the 1st hour (43.1 vs. 92.9%), 6th hour (20.0 vs. 68.6%) and 12th hour (7.7 vs. 24.3%) after surgery (for all periods, P < 0.001). Fewer patients in the case group experienced vomiting at the first (13.8 vs. 51.4%) and 6th hour (0 vs. 20%) after surgery (for both P < 0.001). The use of pethidine was also statistically less in the case group in the same hours after surgery (for all of them, P < 0.001). Rectal indomethacin before laparoscopic cholecystectomy led to lower postoperative nausea and vomiting.

Efficient Quantum Pseudorandomness.

PubMed

Brandão, Fernando G S L; Harrow, Aram W; Horodecki, Michał

2016-04-29

Randomness is both a useful way to model natural systems and a useful tool for engineered systems, e.g., in computation, communication, and control. Fully random transformations require exponential time for either classical or quantum systems, but in many cases pseudorandom operations can emulate certain properties of truly random ones. Indeed, in the classical realm there is by now a well-developed theory regarding such pseudorandom operations. However, the construction of such objects turns out to be much harder in the quantum case. Here, we show that random quantum unitary time evolutions ("circuits") are a powerful source of quantum pseudorandomness. This gives for the first time a polynomial-time construction of quantum unitary designs, which can replace fully random operations in most applications, and shows that generic quantum dynamics cannot be distinguished from truly random processes. We discuss applications of our result to quantum information science, cryptography, and understanding the self-equilibration of closed quantum dynamics.

Orthopaedic resident preparedness for closed reduction and pinning of pediatric supracondylar fractures is improved by e-learning: a multisite randomized controlled study.

PubMed

Hearty, Thomas; Maizels, Max; Pring, Maya; Mazur, John; Liu, Raymond; Sarwark, John; Janicki, Joseph

2013-09-04

There is a need to provide more efficient surgical training methods for orthopaedic residents. E-learning could possibly increase resident surgical preparedness, confidence, and comfort for surgery. Using closed reduction and pinning of pediatric supracondylar humeral fractures as the index case, we hypothesized that e-learning could increase resident knowledge acquisition for case preparation in the operating room. An e-learning surgical training module was created on the Computer Enhanced Visual Learning platform. The module provides a detailed and focused road map of the procedure utilizing a multimedia format. A multisite prospective randomized controlled study design compared residents who used a textbook for case preparation (control group) with residents who used the same textbook plus completed the e-learning module (test group). All subjects completed a sixty-question test on the theory and methods of the case. After completion of the test, the control group then completed the module as well. All subjects were surveyed on their opinion regarding the effectiveness of the module after performing an actual surgical case. Twenty-eight subjects with no previous experience in this surgery were enrolled at four academic centers. Subjects were randomized into two equal groups. The test group scored significantly better (p < 0.001) and demonstrated competence on the test compared with the control group; the mean correct test score (and standard deviation) was 90.9% ± 6.8% for the test group and 73.5% ± 6.4% for the control group. All residents surveyed (n = 27) agreed that the module is a useful supplement to traditional methods for case preparation and twenty-two of twenty-seven residents agreed that it reduced their anxiety during the case and improved their attention to surgical detail. E-learning using the Computer Enhanced Visual Learning platform significantly improved preparedness, confidence, and comfort with percutaneous closed reduction and pinning of a pediatric supracondylar humeral fracture. We believe that adapting such methods into residency training programs will improve efficiency in surgical training.

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

PubMed

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

2012-11-01

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

Effects of royal jelly supplementation on glycemic control and oxidative stress factors in type 2 diabetic female: a randomized clinical trial.

PubMed

Pourmoradian, Samira; Mahdavi, Reza; Mobasseri, Majid; Faramarzi, Elnaz; Mobasseri, Mehrnoosh

2014-05-01

It has been proposed that royal jelly has antioxidant properties and may improve oxidative stress and glycemic control. Therefore, we investigated the effects of royal jelly supplementation in diabetic females. In this pilot, parallel design randomized clinical trial, 50 female volunteers with type 2 diabetes were randomly allocated to the supplemented (25, cases) and placebo (25, cases) groups, based on random block procedure produced by Random Allocation Software, given a daily dose of 1,000 mg royal jelly soft gel or placebo, respectively, for 8 weeks. Before and after intervention, glycemic control indices, antioxidant and oxidative stress factors were measured. After royal jelly supplementation, the mean fasting blood glucose decreased remarkably (163.05±42.51 mg/dL vs. 149.68±42.7 mg/dL). Royal jelly supplementation resulted in significant reduction in the mean serum glycosylated hemoglobin levels (8.67%±2.24% vs. 7.05%±1.45%, P=0.001) and significant elevation in the mean insulin concentration (70.28±29.16 pmol/L vs. 86.46±27.50 pmol/L, P=0.01). Supplementation significantly increased erythrocyte superoxidase dismutase and glutathione peroxidase activities and decreased malondialdehyde levels (P<0.05). At the end of study, the mean total antioxidant capacity elevated insignificantly in both groups. On the basis of our findings, it seems that royal jelly supplementation may be beneficial in controlling diabetes outcomes. Further studies with larger sample size are warranted.

Should Controls With Respiratory Symptoms Be Excluded From Case-Control Studies of Pneumonia Etiology? Reflections From the PERCH Study

PubMed Central

Hammitt, Laura L.; Deloria Knoll, Maria; Baggett, Henry C.; Brooks, W. Abdullah; Howie, Stephen R. C.; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; Scott, J. Anthony G.; Thea, Donald M.; Driscoll, Amanda J.; Karron, Ruth A.; Park, Daniel E.; Prosperi, Christine; Zeger, Scott L.; O’Brien, Katherine L.; Feikin, Daniel R.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey

2017-01-01

Abstract Many pneumonia etiology case-control studies exclude controls with respiratory illness from enrollment or analyses. Herein we argue that selecting controls regardless of respiratory symptoms provides the least biased estimates of pneumonia etiology. We review 3 reasons investigators may choose to exclude controls with respiratory symptoms in light of epidemiologic principles of control selection and present data from the Pneumonia Etiology Research for Child Health (PERCH) study where relevant to assess their validity. We conclude that exclusion of controls with respiratory symptoms will result in biased estimates of etiology. Randomly selected community controls, with or without respiratory symptoms, as long as they do not meet the criteria for case-defining pneumonia, are most representative of the general population from which cases arose and the least subject to selection bias. PMID:28575354

Educating resident physicians using virtual case-based simulation improves diabetes management: a randomized controlled trial.

PubMed

Sperl-Hillen, JoAnn; O'Connor, Patrick J; Ekstrom, Heidi L; Rush, William A; Asche, Stephen E; Fernandes, Omar D; Appana, Deepika; Amundson, Gerald H; Johnson, Paul E; Curran, Debra M

2014-12-01

To test a virtual case-based Simulated Diabetes Education intervention (SimDE) developed to teach primary care residents how to manage diabetes. Nineteen primary care residency programs, with 341 volunteer residents in all postgraduate years (PGY), were randomly assigned to a SimDE intervention group or control group (CG). The Web-based interactive educational intervention used computerized virtual patients who responded to provider actions through programmed simulation models. Eighteen distinct learning cases (L-cases) were assigned to SimDE residents over six months from 2010 to 2011. Impact was assessed using performance on four virtual assessment cases (A-cases), an objective knowledge test, and pre-post changes in self-assessed diabetes knowledge and confidence. Group comparisons were analyzed using generalized linear mixed models, controlling for clustering of residents within residency programs and differences in baseline knowledge. The percentages of residents appropriately achieving A-case composite clinical goals for glucose, blood pressure, and lipids were as follows: A-case 1: SimDE = 21.2%, CG = 1.8%, P = .002; A-case 2: SimDE = 15.7%, CG = 4.7%, P = .02; A-case 3: SimDE = 48.0%, CG = 10.4%, P < .001; and A-case 4: SimDE = 42.1%, CG = 18.7%, P = .004. The mean knowledge score and pre-post changes in self-assessed knowledge and confidence were significantly better for SimDE group than CG participants. A virtual case-based simulated diabetes education intervention improved diabetes management skills, knowledge, and confidence for primary care residents.

Study design and hierarchy of evidence for surgical decision making.

PubMed

Sprague, Sheila; McKay, Paula; Thoma, Achilleas

2008-04-01

This article provides a historical overview of the hierarchy of evidence for surgical decision making and discusses key study designs in the hierarchy of evidence. This encompasses meta-analyses, randomized controlled trials, and observational studies, including cohort and case-controlled studies, case series and case reports, and basic science studies. This article also reviews the principles and importance of evidence-based plastic surgery and describes several systems to rate the strength of the scientific evidence.

Effect of Hibiscus sabdariffa Calices on Dyslipidemia in Obese Adolescents: A Triple-masked Randomized Controlled Trial

PubMed Central

Sabzghabaee, Ali Mohammad; Ataei, Ehsan; Kelishadi, Roya; Ghannadi, Alireza; Soltani, Rasool; Badri, Shirinsadat; Shirani, Shahin

2013-01-01

Conflict of interest: none declared. Objective We aimed to evaluate the effects of Hibiscus sabdariffa (HS) calices on controlling dyslipidemia in obese adolescents. Methodology In this triple blind randomized placebo-controlled clinical trial which was registered in the Iranian registry for clinical trials (IRCT201109122306N2), 90 obese adolescents aged 12-18 years with documented dyslipidemia were randomly assigned in two groups of cases who received 2 grams of fine powdered calices of Hibiscus sabdariffa per day for one month and controls who received placebo powder with the same dietary and physical activity recommendations and duration of exposure. Full lipid profile and fasting blood sugar measured before and after the trial. Data were analyzed using multivariate general linear model. Findings Overall, 72 participants (mean age of 14.21±1.6, 35 boys) completed the trial. The two arms of the study (cases and controls) were not statistically different in terms of age, gender, weight, body mass index (BMI) and lipid profile before the trial. Serum total cholesterol, low density lipoprotein cholesterol and serum triglyceride showed a significant decrease in cases group but high density lipoprotein cholesterol level was not changed significantly. Conclusion It is concluded that Hibiscus sabdariffa calyces powder may have significant positive effects on lipid profile of adolescents which maybe attributed to its polyphenolic and antioxidant content. Further studies are needed on dose-response and formulation optimization. PMID:24082826

Nurse Case Management and Housing Interventions Reduce Allergen Exposures: The Milwaukee Randomized Controlled Trial

PubMed Central

Breysse, Jill; Wendt, Jean; Dixon, Sherry; Murphy, Amy; Wilson, Jonathan; Meurer, John; Cohn, Jennifer; Jacobs, David E.

2011-01-01

Objective We examined the impact of a combination of home environmental interventions and nurse case management services on total settled dust loadings and on allergen concentrations in the homes of asthmatic children. Methods Using a randomized longitudinal controlled trial study design, we randomly assigned homes of asthmatic children in Milwaukee to either a control (n=64) or an intervention (n=57) group. Control group homes received a visual assessment, education, bed/pillow dust mite encasings, and treatment of lead-based paint hazards. The intervention group received these same services plus nurse case management that included tailored, individual asthma action plans, provision of minor home repairs, home cleaning using special vacuuming and wet washing, and integrated pest management. Dust vacuum samples were collected from measured surface areas of floors in the TV room, kitchen, and child's bedroom at baseline and at three-, six-, and 12-month follow-up visits. Dust loading (mass per surface area) is a means of measuring total dust and the total amount of allergen present. Results For the intervention group, geometric mean dust loadings declined significantly from baseline (39 milligrams per square foot [mg/ft2]) to post-intervention (11 mg/ft2) (p<0.001). Baseline dust loading, treatment group, visit, and season were significant predictors of follow-up dust loadings. Mean post-intervention dust loadings were 72% higher in the control group. The total amount of allergen in settled house dust declined significantly following the intervention because total dust loading declined; the concentration of allergens in settled dust did not change significantly. Conclusion The combination of nurse case management and home environmental interventions promotes collaboration between health and housing professionals and is effective in reducing exposures to allergens in settled dust. PMID:21563716

The Role of Prostatitis in Prostate Cancer: Meta-Analysis

PubMed Central

Yunxia, Zhang; Zhu, Hong; Liu, Junjiang; Pumill, Chris

2013-01-01

Objective Use systematic review methods to quantify the association between prostatitis and prostate cancer, under both fixed and random effects model. Evidence Acquisition Case control studies of prostate cancer with information on prostatitis history. All studies published between 1990-2012, were collected to calculate a pooled odds ratio. Selection criteria: the selection criteria are as follows: human case control studies; published from May 1990 to July 2012; containing number of prostatitis, and prostate cancer cases. Evidence Synthesis In total, 20 case control studies were included. A significant association between prostatitis and prostate cancer was found, under both fixed effect model (pooled OR=1.50, 95%CI: 1.39-1.62), and random effects model (OR=1.64, 95%CI: 1.36-1.98). Personal interview based case control studies showed a high level of association (fixed effect model: pooled OR=1.59, 95%CI: 1.47-1.73, random effects model: pooled OR= 1.87, 95%CI: 1.52-2.29), compared with clinical based studies (fixed effect model: pooled OR=1.05, 95%CI: 0.86-1.28, random effects model: pooled OR= 0.98, 95%CI: 0.67-1.45). Additionally, pooled ORs, were calculated for each decade. In a fixed effect model: 1990’s: OR=1.58, 95% CI: 1.35-1.84; 2000’s: OR=1.59, 95% CI: 1.40-1.79; 2010’s: OR=1.37, 95% CI: 1.22-1.56. In a random effects model: 1990’s: OR=1.98, 95% CI: 1.08-3.62; 2000’s: OR=1.64, 95% CI: 1.23-2.19; 2010’s: OR=1.34, 95% CI: 1.03-1.73. Finally a meta-analysis stratified by each country was conducted. In fixed effect models, U.S: pooled OR =1.45, 95%CI: 1.34-1.57; China: pooled OR =4.67, 95%CI: 3.08-7.07; Cuba: pooled OR =1.43, 95%CI: 1.00-2.04; Italy: pooled OR =0.61, 95%CI: 0.13-2.90. In random effects model, U.S: pooled OR=1.50, 95%CI: 1.25-1.80; China: pooled OR =4.67, 95%CI: 3.08-7.07; Cuba: pooled OR =1.43, 95%CI: 1.00-2.04; Italy: pooled OR =0.61, 95%CI: 0.13-2.90.CONCLUSIONS: the present meta-analysis provides the statistical evidence that the association between prostatitis and prostate cancer is significant. PMID:24391995

Analysis of Clinical Cohort Data Using Nested Case-control and Case-cohort Sampling Designs. A Powerful and Economical Tool.

PubMed

Ohneberg, K; Wolkewitz, M; Beyersmann, J; Palomar-Martinez, M; Olaechea-Astigarraga, P; Alvarez-Lerma, F; Schumacher, M

2015-01-01

Sampling from a large cohort in order to derive a subsample that would be sufficient for statistical analysis is a frequently used method for handling large data sets in epidemiological studies with limited resources for exposure measurement. For clinical studies however, when interest is in the influence of a potential risk factor, cohort studies are often the first choice with all individuals entering the analysis. Our aim is to close the gap between epidemiological and clinical studies with respect to design and power considerations. Schoenfeld's formula for the number of events required for a Cox' proportional hazards model is fundamental. Our objective is to compare the power of analyzing the full cohort and the power of a nested case-control and a case-cohort design. We compare formulas for power for sampling designs and cohort studies. In our data example we simultaneously apply a nested case-control design with a varying number of controls matched to each case, a case cohort design with varying subcohort size, a random subsample and a full cohort analysis. For each design we calculate the standard error for estimated regression coefficients and the mean number of distinct persons, for whom covariate information is required. The formula for the power of a nested case-control design and the power of a case-cohort design is directly connected to the power of a cohort study using the well known Schoenfeld formula. The loss in precision of parameter estimates is relatively small compared to the saving in resources. Nested case-control and case-cohort studies, but not random subsamples yield an attractive alternative for analyzing clinical studies in the situation of a low event rate. Power calculations can be conducted straightforwardly to quantify the loss of power compared to the savings in the num-ber of patients using a sampling design instead of analyzing the full cohort.

[Efficacy of Weitan Waifu patch on the postsurgical gastroparesis syndrome of gastrointestinal cancer: a multi-center trial].

PubMed

Zhou, Q; Zuo, M H; Li, Q W; Tian, Y T; Xie, Y B; Wang, Y B; Yang, G Y; Ye, Y J; Guo, P; Liu, J P; Liu, Z L; An, C; Zhou, T; Tian, Z; Liu, C B; Hu, Y; Chi, X Y; Shen, Y; Xia, Y; Hu, K W

2017-12-23

Objective: To investigate the safety and efficacy of the Weitan Waifu patch on the postsurgical gastroparesis syndrome (PGS) of gastrointestinal cancer. Methods: The multi-center, double-blind, randomized controlled trial was conducted with superiority design. Patients with PGS of gastrointestinal cancer diagnosed in 4 AAA hospitals and the abdominal symptom manifested as cold syndrome by Chinese local syndrome differentiation were recruited. These patients were randomly divided into two groups according to 1∶1 proportion. Placebo or Weitan Waifu patch was applied in control group or intervention group, respectively, based on the basic treatments, including nutrition support, gastrointestinal decompression, promoting gastric dynamics medicine.Two acupuncture points (Zhongwan and Shenque) were stuck with placebo in control group or patch in treatment group. The intervention course was 14 days or reached the effective standard. Results: From July 15, 2013 to Jun 3, 2015, 128 participants were recruited and 120 eligible cases were included in the full analysis set (FAS), and 60 cases in each group. 88 cases were included in the per-protocol set (PPS), including 45 cases in the treatment group and 43 cases in the control group. In the FAS, the clinical effective rate in the treatment group was 68.3%, significantly superior than 41.7% of the control group ( P =0.003). The medium time of effective therapy in the treatment group was 8 days, significantly shorter than 10 days in the control group ( P =0.017). In the FAS, 3 adverse events occurred in the treatment group, including mild to moderate decrustation, pruritus and nausea. The incidence rate of adverse events was 5.0% (3/60) and these symptoms were spontaneously remitted after drug withdrawal. No severe adverse events were observed in the control group. There was no significant difference between these two groups ( P =0.244). Conclusion: Weitan Waifu patch is a safely and effectively therapeutic method for patients with PGS (cold syndrome) of gastroenterological cancer. Trial registration: International Standard Randomized Controlled Trial Number Register, ISRCTN18291857.

Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study.

PubMed

Razzano, Cristina; Carbone, Stefano; Mangone, Massimiliano; Iannotta, M Raffaella; Battaglia, Alessandro; Santilli, Valter

The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

[The randomized controlled trial of the treatment for clavicular fracture by rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation].

PubMed

Bi, Hong-zheng; Yang, Mao-qing; Tan, Yuan-chao; Fu, Song

2008-07-01

To study the curative effect and safety of rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation in treating clavicular fracture. All 201 cases of clavicular fractures were randomly divided into treatment group (101 cases) and control group (100 cases). The treatment group was treated by rotatory manual reduction with forceps holder and retrograde percutaneous pinning transfixation. The control group was treated by open reduction and internal fixation with Kirschner pin. All cases were followed up for 4 to 21 months (mean 10.6 months). SPSS was used to analyze clinic healing time of fracture and shoulder-joint function in both two groups. After operation, 101 cases of treatment group achieved union of fracture and the clinical healing time was 28 to 49 days (mean 34.5+/-2.7 days). In control group,there were 4 cases with nonunion of fracture,the other 96 cases were union,the clinical healing time was 36 to 92 days (mean 55.3+/-4.8 days). The excellent and good rate of shoulder-joint function was 100% in treatment group and 83% in control group. By t-test and chi2-test, there was significant difference between the two groups in curative effect (P<0.05). Rotatory manual reduction with forceps holder and retrograde pinning transfixation can be used in various kinds of clavicular shaft fracture, with many virtues such as easy operation, reliable fixation, short union time of fracture, good functional recovery of shoulder-joint and no incision scar affecting appearance.

Single-case experimental design yielded an effect estimate corresponding to a randomized controlled trial.

PubMed

Shadish, William R; Rindskopf, David M; Boyajian, Jonathan G

2016-08-01

We reanalyzed data from a previous randomized crossover design that administered high or low doses of intravenous immunoglobulin (IgG) to 12 patients with hypogammaglobulinaemia over 12 time points, with crossover after time 6. The objective was to see if results corresponded when analyzed as a set of single-case experimental designs vs. as a usual randomized controlled trial (RCT). Two blinded statisticians independently analyzed results. One analyzed the RCT comparing mean outcomes of group A (high dose IgG) to group B (low dose IgG) at the usual trial end point (time 6 in this case). The other analyzed all 12 time points for the group B patients as six single-case experimental designs analyzed together in a Bayesian nonlinear framework. In the randomized trial, group A [M = 794.93; standard deviation (SD) = 90.48] had significantly higher serum IgG levels at time six than group B (M = 283.89; SD = 71.10) (t = 10.88; df = 10; P < 0.001), yielding a mean difference of MD = 511.05 [standard error (SE) = 46.98]. For the single-case experimental designs, the effect from an intrinsically nonlinear regression was also significant and comparable in size with overlapping confidence intervals: MD = 495.00, SE = 54.41, and t = 495.00/54.41 = 9.10. Subsequent exploratory analyses indicated that how trend was modeled made a difference to these conclusions. The results of single-case experimental designs accurately approximated results from an RCT, although more work is needed to understand the conditions under which this holds. Copyright © 2016 Elsevier Inc. All rights reserved.

Does Mckuer's Law Hold for Heart Rate Control via Biofeedback Display?

NASA Technical Reports Server (NTRS)

Courter, B. J.; Jex, H. R.

1984-01-01

Some persons can control their pulse rate with the aid of a biofeedback display. If the biofeedback display is modified to show the error between a command pulse-rate and the measured rate, a compensatory (error correcting) heart rate tracking control loop can be created. The dynamic response characteristics of this control loop when subjected to step and quasi-random disturbances were measured. The control loop includes a beat-to-beat cardiotachmeter differenced with a forcing function from a quasi-random input generator; the resulting error pulse-rate is displayed as feedback. The subject acts to null the displayed pulse-rate error, thereby closing a compensatory control loop. McRuer's Law should hold for this case. A few subjects already skilled in voluntary pulse-rate control were tested for heart-rate control response. Control-law properties are derived, such as: crossover frequency, stability margins, and closed-loop bandwidth. These are evaluated for a range of forcing functions and for step as well as random disturbances.

Health effects of cow's milk consumption in infants up to 3 years of age: a systematic review and meta-analysis.

PubMed

Griebler, Ursula; Bruckmüller, Melanie U; Kien, Christina; Dieminger, Birgit; Meidlinger, Bettina; Seper, Katrin; Hitthaller, Ariane; Emprechtinger, Robert; Wolf, Alexandra; Gartlehner, Gerald

2016-02-01

To summarize the best available evidence regarding the short- and long-term health effects of cow's milk intake in healthy, full-term infants up to 3 years of age. We conducted a systematic review and meta-analysis. We searched MEDLINE (via PubMed), EMBASE and the Cochrane Library between 1960 and July 2013 and manually reviewed reference lists of pertinent articles. Two researchers independently reviewed abstracts and full-text articles and extracted relevant data. We included (randomized/non-randomized) controlled trials and observational studies. We included data from twenty-three studies (one randomized controlled trial, four non-randomized controlled trials, eight case-control studies and ten cohort studies) for the evidence synthesis. Pooled results of four studies revealed a higher risk of Fe-deficiency anaemia for infants consuming cow's milk compared with those consuming follow-on formula (relative risk=3·76; 95 % CI 2·73, 5·19). For type 1 diabetes mellitus, six out of seven case-control studies did not show a difference in the risk of developing this disease based on the age of introduction of cow's milk. We did not find negative associations for other health effects. Cow's milk consumption in infancy is associated with an increased risk of developing Fe-deficiency anaemia. Limiting cow's milk consumption may be important to ensure an adequate Fe intake for infants and toddlers. High-quality patient information for caregivers is needed on how infants' Fe requirements can be met.

Should Controls With Respiratory Symptoms Be Excluded From Case-Control Studies of Pneumonia Etiology? Reflections From the PERCH Study.

PubMed

Higdon, Melissa M; Hammitt, Laura L; Deloria Knoll, Maria; Baggett, Henry C; Brooks, W Abdullah; Howie, Stephen R C; Kotloff, Karen L; Levine, Orin S; Madhi, Shabir A; Murdoch, David R; Scott, J Anthony G; Thea, Donald M; Driscoll, Amanda J; Karron, Ruth A; Park, Daniel E; Prosperi, Christine; Zeger, Scott L; O'Brien, Katherine L; Feikin, Daniel R

2017-06-15

Many pneumonia etiology case-control studies exclude controls with respiratory illness from enrollment or analyses. Herein we argue that selecting controls regardless of respiratory symptoms provides the least biased estimates of pneumonia etiology. We review 3 reasons investigators may choose to exclude controls with respiratory symptoms in light of epidemiologic principles of control selection and present data from the Pneumonia Etiology Research for Child Health (PERCH) study where relevant to assess their validity. We conclude that exclusion of controls with respiratory symptoms will result in biased estimates of etiology. Randomly selected community controls, with or without respiratory symptoms, as long as they do not meet the criteria for case-defining pneumonia, are most representative of the general population from which cases arose and the least subject to selection bias. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Association between non-steroidal anti-inflammatory drug use and melanoma risk: a meta-analysis of 13 studies.

PubMed

Li, Shan; Liu, Yanqiong; Zeng, Zhiyu; Peng, Qiliu; Li, Ruolin; Xie, Li; Qin, Xue; Zhao, Jinmin

2013-08-01

Results of the association between non-steroidal anti-inflammatory drugs (NSAIDs) and melanoma risk have been inconsistent. We performed a meta-analysis of relevant studies to investigate the hypothesis of an association between NSAID use and melanoma risk. Systematic searches of the PubMed and several other databases up to 23 March 2013 were retrieved. All epidemiologic studies regarding NSAIDs and melanoma risk were included. Fixed- or random-effects meta-analytical models were used to calculate relative risk (RR) and corresponding 95 % confidence intervals (CIs). Sensitivity analyses, Galbraith plots, and subgroup analyses were also performed. Six case-control studies including 93,432 melanoma cases and 401,251 controls, six cohort studies consisting of 563,380 subjects, and one randomized controlled trial encompassing 39,876 participants were included in this analysis. Compared to non-use, ever use of any NSAIDs was not statistically significantly associated with melanoma risk based on the random-effects models (RR = 0.97, 95 % CI = 0.90-10.4, p = 0.401). No differences were found in the effects on melanoma risk of aspirin, non-aspirin NSAIDs, and cyclooxygenase-2 inhibitor use overall and stratified by gender. However, a slight reduction in the risk of melanoma by taking aspirin was observed in case-control studies (RR = 0.88, 95 % CI = 0.80-0.96, p = 0.004). Findings from this pooled analysis do not support the hypothesis that NSAID use provides potential benefits in preventing melanoma. More and larger randomized trials, including adequate numbers of patients, are required to further evaluate the relationship between NSAID use and melanoma.

Using Virtual Reality and Videogames for Traumatic Brain Injury Rehabilitation: A Structured Literature Review.

PubMed

Pietrzak, Eva; Pullman, Stephen; McGuire, Annabel

2014-08-01

This article reviews the available literature about the use of novel methods of rehabilitation using virtual reality interventions for people living with posttraumatic brain injuries. The MEDLINE, EMBASE, SCOPUS, and Cochrane Library databases were searched using the terms "virtual reality" OR "video games" AND "traumatic brain injury." Included studies investigated therapeutic use of virtual reality in adults with a brain trauma resulting from acquired closed head injury, reported outcomes that included measures of motor or cognitive functionality, and were published in a peer-reviewed journal written in English. Eighteen articles fulfilled inclusion criteria. Eight were case studies, five studies had a quasi-experimental design with a pre-post comparison, and five were pilot randomized control trials or comparative studies. The virtual reality systems used were commercial or custom designed for the study and ranged from expensive, fully immersive systems to cheap online games or videogames. In before-after comparisons, improvements in balance were seen in four case studies and two small randomized control trials. Between-group comparisons in these randomized control trials showed no difference between virtual reality and traditional therapy. Post-training improvements were also seen for upper extremity functions (five small studies) and for various cognitive function measures (four case studies and one pilot randomized control trial). Attitudes of participants toward virtual reality interventions was more positive than for traditional therapy (three studies). The evidence that the use of virtual reality in rehabilitation of traumatic brain injury improves motor and cognitive functionality is currently very limited. However, this approach has the potential to provide alternative, possibly more affordable and available rehabilitation therapy for traumatic brain injury in settings where access to therapy is limited by geographical or financial constraints.

Infinite non-causality in active cancellation of random noise

NASA Astrophysics Data System (ADS)

Friot, Emmanuel

2006-03-01

Active cancellation of broadband random noise requires the detection of the incoming noise with some time advance. In an duct for example this advance must be larger than the delays in the secondary path from the control source to the error sensor. In this paper it is shown that, in some cases, the advance required for perfect noise cancellation is theoretically infinite because the inverse of the secondary path, which is required for control, can include an infinite non-causal response. This is shown to be the result of two mechanisms: in the single-channel case (one control source and one error sensor), this can arise because of strong echoes in the control path. In the multi-channel case this can arise even in free field simply because of an unfortunate placing of sensors and actuators. In the present paper optimal feedforward control is derived through analytical and numerical computations, in the time and frequency domains. It is shown that, in practice, the advance required for significant noise attenuation can be much larger than the secondary path delays. Practical rules are also suggested in order to prevent infinite non-causality from appearing.

Random Forest Application for NEXRAD Radar Data Quality Control

NASA Astrophysics Data System (ADS)

Keem, M.; Seo, B. C.; Krajewski, W. F.

2017-12-01

Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e.g., MRMS). They also discuss operational feasibility based on the observed strength and weakness of the method.

Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

PubMed Central

Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Kelishadi, Roya

2014-01-01

Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were randomly assigned to two groups of equal number receiving zinc (10 mg/day) or placebo for 12 weeks. Results: Overall 77 children completed the trial (39 in the case and 3 in the control group).The results showed that zinc supplement can improve calorie intake in children by affecting some CEBQ subscales like Emotional over Eating and Food Responsible. Conclusion: Zinc supplementation had positive impact in promoting the calorie intake and some subscales of anorexia. PMID:25674110

Identification and selection of cases and controls in the Pneumonia Etiology Research for Child Health project.

PubMed

Deloria-Knoll, Maria; Feikin, Daniel R; Scott, J Anthony G; O'Brien, Katherine L; DeLuca, Andrea N; Driscoll, Amanda J; Levine, Orin S

2012-04-01

Methods for the identification and selection of patients (cases) with severe or very severe pneumonia and controls for the Pneumonia Etiology Research for Child Health (PERCH) project were needed. Issues considered include eligibility criteria and sampling strategies, whether to enroll hospital or community controls, whether to exclude controls with upper respiratory tract infection (URTI) or nonsevere pneumonia, and matching criteria, among others. PERCH ultimately decided to enroll community controls and an additional human immunodeficiency virus (HIV)-infected control group at high HIV-prevalence sites matched on age and enrollment date of cases; controls with symptoms of URTI or nonsevere pneumonia will not be excluded. Systematic sampling of cases (when necessary) and random sampling of controls will be implemented. For each issue, we present the options that were considered, the advantages and disadvantages of each, the rationale for the methods selected for PERCH, and remaining implications and limitations.

Rapid case-based mapping of seasonal malaria transmission risk for strategic elimination planning in Swaziland

PubMed Central

2013-01-01

Background As successful malaria control programmes move towards elimination, they must identify residual transmission foci, target vector control to high-risk areas, focus on both asymptomatic and symptomatic infections, and manage importation risk. High spatial and temporal resolution maps of malaria risk can support all of these activities, but commonly available malaria maps are based on parasite rate, a poor metric for measuring malaria at extremely low prevalence. New approaches are required to provide case-based risk maps to countries seeking to identify remaining hotspots of transmission while managing the risk of transmission from imported cases. Methods Household locations and travel histories of confirmed malaria patients during 2011 were recorded through routine surveillance by the Swaziland National Malaria Control Programme for the higher transmission months of January to April and the lower transmission months of May to December. Household locations for patients with no travel history to endemic areas were compared against a random set of background points sampled proportionate to population density with respect to a set of variables related to environment, population density, vector control, and distance to the locations of identified imported cases. Comparisons were made separately for the high and low transmission seasons. The Random Forests regression tree classification approach was used to generate maps predicting the probability of a locally acquired case at 100 m resolution across Swaziland for each season. Results Results indicated that case households during the high transmission season tended to be located in areas of lower elevation, closer to bodies of water, in more sparsely populated areas, with lower rainfall and warmer temperatures, and closer to imported cases than random background points (all p < 0.001). Similar differences were evident during the low transmission season. Maps from the fit models suggested better predictive ability during the high season. Both models proved useful at predicting the locations of local cases identified in 2012. Conclusions The high-resolution mapping approaches described here can help elimination programmes understand the epidemiology of a disappearing disease. Generating case-based risk maps at high spatial and temporal resolution will allow control programmes to direct interventions proactively according to evidence-based measures of risk and ensure that the impact of limited resources is maximized to achieve and maintain malaria elimination. PMID:23398628

Rapid case-based mapping of seasonal malaria transmission risk for strategic elimination planning in Swaziland.

PubMed

Cohen, Justin M; Dlamini, Sabelo; Novotny, Joseph M; Kandula, Deepika; Kunene, Simon; Tatem, Andrew J

2013-02-11

As successful malaria control programmes move towards elimination, they must identify residual transmission foci, target vector control to high-risk areas, focus on both asymptomatic and symptomatic infections, and manage importation risk. High spatial and temporal resolution maps of malaria risk can support all of these activities, but commonly available malaria maps are based on parasite rate, a poor metric for measuring malaria at extremely low prevalence. New approaches are required to provide case-based risk maps to countries seeking to identify remaining hotspots of transmission while managing the risk of transmission from imported cases. Household locations and travel histories of confirmed malaria patients during 2011 were recorded through routine surveillance by the Swaziland National Malaria Control Programme for the higher transmission months of January to April and the lower transmission months of May to December. Household locations for patients with no travel history to endemic areas were compared against a random set of background points sampled proportionate to population density with respect to a set of variables related to environment, population density, vector control, and distance to the locations of identified imported cases. Comparisons were made separately for the high and low transmission seasons. The Random Forests regression tree classification approach was used to generate maps predicting the probability of a locally acquired case at 100 m resolution across Swaziland for each season. Results indicated that case households during the high transmission season tended to be located in areas of lower elevation, closer to bodies of water, in more sparsely populated areas, with lower rainfall and warmer temperatures, and closer to imported cases than random background points (all p < 0.001). Similar differences were evident during the low transmission season. Maps from the fit models suggested better predictive ability during the high season. Both models proved useful at predicting the locations of local cases identified in 2012. The high-resolution mapping approaches described here can help elimination programmes understand the epidemiology of a disappearing disease. Generating case-based risk maps at high spatial and temporal resolution will allow control programmes to direct interventions proactively according to evidence-based measures of risk and ensure that the impact of limited resources is maximized to achieve and maintain malaria elimination.

Dynamical Localization for Discrete and Continuous Random Schrödinger Operators

NASA Astrophysics Data System (ADS)

Germinet, F.; De Bièvre, S.

We show for a large class of random Schrödinger operators Ho on and on that dynamical localization holds, i.e. that, with probability one, for a suitable energy interval I and for q a positive real, Here ψ is a function of sufficiently rapid decrease, and PI(Ho) is the spectral projector of Ho corresponding to the interval I. The result is obtained through the control of the decay of the eigenfunctions of Ho and covers, in the discrete case, the Anderson tight-binding model with Bernoulli potential (dimension ν = 1) or singular potential (ν > 1), and in the continuous case Anderson as well as random Landau Hamiltonians.

Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

PubMed Central

Duara, Rajnish; Misra, Manoranjan; Bhuyan, Ritwick Raj; Sarma, P. Sankara; Jayakumar, Karunakaran

2008-01-01

Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1) cases where residual pump blood was used and (2) controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained. PMID:20041077

Effects of a case management program on patients with oral precancerous lesions: a randomized controlled trial.

PubMed

Lin, Hsiu-Ying; Chen, Shu-Ching; Peng, Hsi-Ling; Chen, Mu-Kuan

2016-01-01

The aim of this study is to identify the effects of a case management program on knowledge about oral cancer, preventive behavior for oral cancer, and level of uncertainty for patients with oral precancerous lesions. A randomized controlled trial was conducted with two groups, using a pre- and posttest design. The experimental group received a case management program and telephone follow-up sessions; the control group received routine care. Patients were assessed at three time points: first visit to the otolaryngology clinic for biopsy examination (T0), and then at 2 weeks (T1) and 4 weeks (T2) after the biopsy examination. Patients in both groups had significantly higher levels of knowledge about oral cancer, preventive behavior for oral cancer, and lower level of uncertainty at T2 compared to T0. At T2, participants in the experimental group had significantly greater knowledge about oral cancer, more preventive behavior for oral cancer, and less uncertainty compared to those in the control group. The case management program with telephone counseling effectively improved knowledge about oral cancer, preventive behavior for oral cancer, and uncertainty levels in patients with oral precancerous lesions in the four weeks after receiving a biopsy examination. The case management program can be applied with positive results to patients receiving different types of cancer screening, including colorectal, breast, and cervical screening.

Interesting Practitioners in Training in Empirically Supported Treatments: Research Reviews versus Case Studies

PubMed Central

Stewart, Rebecca E.; Chambless, Dianne L.

2010-01-01

It has been repeatedly demonstrated that clinicians rely more on clinical judgment than on research findings. We hypothesized that psychologists in practice might be more open to adopting empirically supported treatments (ESTs) if outcome results were presented with a case study. Psychologists in private practice (N = 742) were randomly assigned to receive a research review of data from randomized controlled trials of cognitive-behavioral treatment (CBT) and medication for bulimia, a case study of CBT for a fictional patient with bulimia, or both. Results indicated that the inclusion of case examples renders ESTs more compelling and interests clinicians in gaining training. Despite these participants’ training in statistics, the inclusion of the statistical information had no influence on attitudes or training willingness beyond that of the anecdotal case information. PMID:19899142

A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination.

PubMed

Shi, Meng; An, Qian; Ainslie, Kylie E C; Haber, Michael; Orenstein, Walter A

2017-12-08

As annual influenza vaccination is recommended for all U.S. persons aged 6 months or older, it is unethical to conduct randomized clinical trials to estimate influenza vaccine effectiveness (VE). Observational studies are being increasingly used to estimate VE. We developed a probability model for comparing the bias and the precision of VE estimates from two case-control designs: the traditional case-control (TCC) design and the test-negative (TN) design. In both study designs, acute respiratory illness (ARI) patients seeking medical care testing positive for influenza infection are considered cases. In the TN design, ARI patients seeking medical care who test negative serve as controls, while in the TCC design, controls are randomly selected individuals from the community who did not contract an ARI. Our model assigns each study participant a covariate corresponding to the person's health status. The probabilities of vaccination and of contracting influenza and non-influenza ARI depend on health status. Hence, our model allows non-random vaccination and confounding. In addition, the probability of seeking care for ARI may depend on vaccination and health status. We consider two outcomes of interest: symptomatic influenza (SI) and medically-attended influenza (MAI). If vaccination does not affect the probability of non-influenza ARI, then VE estimates from TN studies usually have smaller bias than estimates from TCC studies. We also found that if vaccinated influenza ARI patients are less likely to seek medical care than unvaccinated patients because the vaccine reduces symptoms' severity, then estimates of VE from both types of studies may be severely biased when the outcome of interest is SI. The bias is not present when the outcome of interest is MAI. The TN design produces valid estimates of VE if (a) vaccination does not affect the probabilities of non-influenza ARI and of seeking care against influenza ARI, and (b) the confounding effects resulting from non-random vaccination are similar for influenza and non-influenza ARI. Since the bias of VE estimates depends on the outcome against which the vaccine is supposed to protect, it is important to specify the outcome of interest when evaluating the bias.

Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres.

PubMed

Bradley, Janet; Jayanna, Krishnamurthy; Shaw, Souradet; Cunningham, Troy; Fischer, Elizabeth; Mony, Prem; Ramesh, B M; Moses, Stephen; Avery, Lisa; Crockett, Maryanne; Blanchard, James F

2017-01-07

Birthing in health facilities in India has increased over the last few years, yet maternal and neonatal mortality rates remain high. Clinical mentoring with case sheets or checklists for nurses is viewed as essential for on-going knowledge transfer, particularly where basic training is inadequate. This paper summarizes a study of the effect of such a programme on staff knowledge and skills in a randomized trial of 295 nurses working in 108 Primary Health Centres (PHCs) in Karnataka, India. Stratifying by district, half of the PHCs were randomly assigned to be intervention sites and provided with regular mentoring visits where case sheet/checklists were a central job and teaching aid, and half to be control sites, where no support was provided except provision of case sheets. Nurses' knowledge and skills around normal labour, labour complications and neonate issues were tested before the intervention began and again one year later. Univariate and multivariate analyses were conducted to examine the effect of mentoring and case sheets. Overall, on none of the 3 measures, did case sheet use without mentoring add anything to the basic nursing training when controlling for other factors. Only individuals who used both case-sheets and received mentoring scored significantly higher on the normal labour and neonate indices, scoring almost twice as high as those who only used case-sheets. This group was also associated with significantly higher scores on the complications of labour index, with their scores 2.3 times higher on average than the case sheet only control group. Individuals from facilities with 21 or more deliveries in a month tended to fare worse on all 3 indices. There were no differences in outcomes according to district or years of experience. This study demonstrates that provision of case sheets or checklists alone is insufficient to improve knowledge and practices. However, on-site mentoring in combination with case sheets can have a demonstrable effect on improving nurse knowledge and skills around essential obstetric and neonatal care in remote rural areas of India. We recommend scaling up of this mentoring model in order to improve staff knowledge and skills and reduce maternal and neonatal mortality in India. This study is registered at clinicaltrials.gov, Identifier No. NCT02004912 , November 27, 2013.

Effectiveness of a Brief Home-Based Social Work Motivational Intervention for Male Methamphetamine Users in Tehran: A Randomized Clinical Trial.

PubMed

Danaee-Far, Morteza; Maarefvand, Masoomeh; Rafiey, Hassan

2016-12-05

Methamphetamine, a highly addictive psychostimulant drug, is widely used by substance users who are not motivated to undergo treatment throughout the world, including Iran. This research was conducted to evaluate the effectiveness of a brief home-based social work motivational intervention (HSWMI) to encourage male methamphetamine users to participate in a treatment program. Fifty-six unmotivated male methamphetamine users participated in a randomized controlled trial. The case group received the HSWMI in addition to the usual consulting services in the clinic; the control group just received the usual consulting services. Data were collected 7 and 90 days after the intervention to evaluate participation and retention in a treatment program. Data were analyzed using the chi-square test. Drug users with a mean age of 32.55 years and mean duration of drug use of 7.73 years, participated in the case (n = 28) and control (n = 28) groups. The case group participated in treatment programs significantly more than the control group and the retention rate for the case group was significantly higher than for the control group. This brief HSWMI was effective to increase the motivation of methamphetamine users to participate and remain in treatment programs. This intervention can be implemented by social workers in substance use treatment centers.

Study design and "evidence" in patient-oriented research.

PubMed

Concato, John

2013-06-01

Individual studies in patient-oriented research, whether described as "comparative effectiveness" or using other terms, are based on underlying methodological designs. A simple taxonomy of study designs includes randomized controlled trials on the one hand, and observational studies (such as case series, cohort studies, and case-control studies) on the other. A rigid hierarchy of these design types is a fairly recent phenomenon, promoted as a tenet of "evidence-based medicine," with randomized controlled trials receiving gold-standard status in terms of producing valid results. Although randomized trials have many strengths, and contribute substantially to the evidence base in clinical care, making presumptions about the quality of a study based solely on category of research design is unscientific. Both the limitations of randomized trials as well as the strengths of observational studies tend to be overlooked when a priori assumptions are made. This essay presents an argument in support of a more balanced approach to evaluating evidence, and discusses representative examples from the general medical as well as pulmonary and critical care literature. The simultaneous consideration of validity (whether results are correct "internally") and generalizability (how well results apply to "external" populations) is warranted in assessing whether a study's results are accurate for patients likely to receive the intervention-examining the intersection of clinical and methodological issues in what can be called a medicine-based evidence approach. Examination of cause-effect associations in patient-oriented research should recognize both the strengths and limitations of randomized trials as well as observational studies.

The clinical application of teaching people about pain.

PubMed

Louw, Adriaan; Zimney, Kory; O'Hotto, Christine; Hilton, Sandra

2016-07-01

Teaching people about the neurobiology and neurophysiology of their pain experience has a therapeutic effect and has been referred to as pain neuroscience education (PNE). Various high-quality randomized controlled trials and systematic reviews have shown increasing efficacy of PNE decreasing pain, disability, pain catastrophization, movement restrictions, and healthcare utilization. Research studies, however, by virtue of their design, are very controlled environments and, therefore, in contrast to the ever-increasing evidence for PNE, little is known about the clinical application of this emerging therapy. In contrast, case studies, case series, and expert opinion and perspectives by authorities in the world of pain science provide clinicians with a glimpse into potential "real" clinical application of PNE in the face of the ever-increasing chronic pain epidemic. By taking the material from the randomized controlled trials, systematic reviews, case series, case studies, and expert opinion, this article aims to provide a proposed layout of the clinical application of PNE. The article systematically discusses key elements of PNE including examination, educational content, and delivery methods, merging of PNE with movement, goal setting, and progression. This perspectives article concludes with a call for research into the clinical application of PNE.

Evaluation of effect of letrozole prior to misoprostol in comparison with misoprostol alone in success rate of induced abortion.

PubMed

Behroozi-Lak, T; Derakhshan-Aydenloo, S; Broomand, F

2018-03-01

Abortion, spontaneous or induced, is a common complication of pregnancy and exploration of available and safe regimens for medical abortion in developing countries seems crucial. The present study was aimed to assess the effect of letrozole in combination with misoprostol in women eligible for legal therapeutic abortion with gestational age ≤14weeks. This clinical randomized trial was conducted on 78 women who were candidate of medical abortion and eligible for legal abortion with gestational age ≤14 weeks that were randomly divided into two groups of case and controls. Case group received daily oral dose of 10mg letrozole for three days followed by vaginal misoprostol. In control group the patients received only vaginal misoprostol. The rate of complete abortion, induction-of-abortion time, and side-effects were assessed. Complete abortion was observed in 30 patients (76.9%) in case group and 9 (23.1%) cases were failed. In control group there was 16 (41.03%) complete abortions and 23 (58.97%) cases were failed to abort. Patients with gestational age of between 6 and 10 weeks did not show significant difference in both groups (P=0.134). Regarding pregnancy remnants there were significant differences between two groups (P=0.034). The time form admission to discharge in case groups were significantly shorter than those in control group (P=0.001). The indication for curettage in case group was significantly less than control group (P=0.001). A 3-day course of letrozole (10mg/daily) followed by misoprostol was associated with a higher complete abortion and lower curettage rates and reduction in time from admission to discharge in women with gestational age ≤14 weeks compared to misoprostol alone. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

A 26-year review of emergency peripartum hysterectomy in a tertiary teaching hospital in Kuwait - years 1983-2011.

PubMed

Chibber, Rachana; Al-Hijji, Jassim; Fouda, Mohamed; Al-Saleh, Eyad; Al-Adwani, Abdul Razzak; Mohammed, Asiya Tasneem

2012-01-01

To identify the risk factors and study the incidence, indications and complications of emergency peripartum hysterectomy (EPH). This was a retrospective case-control study. The cases consisted of all women who underwent EPH between January 1983 and January 2011. Two controls per case were randomly selected from the remaining deliveries by using a random number table. Case records were retrieved from the medical records. Among 150,993 deliveries, there were 59 EPHs (cases), giving a rate of 0.390 per 1,000. Of the 59 cases, only 56 were analysed because 3 files were unavailable. These women were older (mean age 36 ± 5.7 vs. 22 ± 5.3 years, p < 0.01) and had delivered more than 1 child (p = 0.02). Thirty-seven (66%) cases had had previous caesarean sections (CSs) and the number of CSs in this group was greater than in the controls (21%, p < 0.01). More index cases had a history of atonic postpartum haemorrhage (46 vs. 4%, p < 0.001) and placenta praevia (34 vs. 4%, p < 0.01). More cases than controls were delivered by CS (73 vs. 29%; p = 0.003). The leading indications for EPH were haemorrhage due to uterine atony and placenta praevia. Independent risk factors were older age, multiparity, history of one or more CSs and placenta praevia. There were 2 maternal deaths from coagulopathy following massive obstetric haemorrhage. The main complications of EPH were febrile morbidity: 12 (21%), wound infection: 8 (14%) and bladder or ureteric injury: 8 (14%). CSs, especially repeat CSs in women with placenta praevia and persistent uterine atony, significantly increased the risks of peripartum hysterectomy. Copyright © 2011 S. Karger AG, Basel.

Yard flooding by irrigation canals increased the risk of West Nile disease in El Paso, Texas

PubMed Central

Cardenas, Victor M.; Jaime, Javier; Ford, Paula B.; Gonzalez, Fernando J.; Carrillo, Irma; Gallegos, Jorge E.; Watts, Douglas M.

2011-01-01

Purpose To investigate the effects of use of water from irrigation canals to flood residential yards on the risk of West Nile disease in El Paso, Texas. Methods West Nile disease confirmed cases in 2009–2010 were compared with a random sample of 50 residents of the county according to access to and use of water from irrigation canals by subjects or their neighbors, as well as geo-referenced closest distance between their home address and the nearest irrigation canal. A windshield survey of 600 meters around the study subjects’ home address recorded the presence of irrigation canals. The distance from the residence of 182 confirmed cases of West Nile disease reported in 2003–2010 to canals was compared to that of the centroids of 182 blocks selected at random. Results Cases were more likely than controls to report their neighbors flooded their yards with water from canals. Irrigation canals were more often observed in neighborhoods of cases than of controls. Using the set of addresses of 182 confirmed cases and 182 hypothetic controls the authors found a statistically significant inverse relation with risk of West Nile disease. Conclusions Flooding of yards with water from canals increased the risk of West Nile disease. PMID:21943648

Yard flooding by irrigation canals increased the risk of West Nile disease in El Paso, Texas.

PubMed

Cardenas, Victor M; Jaime, Javier; Ford, Paula B; Gonzalez, Fernando J; Carrillo, Irma; Gallegos, Jorge E; Watts, Douglas M

2011-12-01

To investigate the effects of use of water from irrigation canals to flood residential yards on the risk of West Nile disease in El Paso, Texas. West Nile disease confirmed cases in 2009 through 2010 were compared with a random sample of 50 residents of the county according to access to and use of water from irrigation canals by subjects or their neighbors, as well as geo-referenced closest distance between their home address and the nearest irrigation canal. A windshield survey of 600 m around the study subjects' home address recorded the presence of irrigation canals. The distance from the residence of 182 confirmed cases of West Nile disease reported in 2003 through 2010 to canals was compared with that of the centroids of 182 blocks selected at random. Cases were more likely than controls to report their neighbors flooded their yards with water from canals. Irrigation canals were more often observed in neighborhoods of cases than of controls. Using the set of addresses of 182 confirmed cases and 182 hypothetical controls the authors found a significant, inverse relation with risk of West Nile disease. Flooding of yards with water from canals increased the risk of West Nile disease. Copyright © 2011 Elsevier Inc. All rights reserved.

Effects of a mobility monitoring system on the cost of care in relation to reimbursement at Swiss nursing homes: learnings from a randomized controlled trial.

PubMed

Stark, Mario; Tietz, Rigo; Gattinger, Heidrun; Hantikainen, Virpi; Ott, Stefan

2017-12-01

Nursing homes in Switzerland are under pressure to efficiently coordinate staff activities to cover their personnel costs under the care financing system. In this study, the use of a mobility monitoring system accompanied with case conferences was investigated in order to improve sleep quality and estimate the cost benefit of this intervention. In an open two-phase randomized controlled trial at three nursing homes, residents with cognitive impairment were randomly assigned to an intervention group and a control group. In the intervention group, a 10-week period of intensive use of the monitoring system and case conferences led by an advanced nurse practitioner (Phase I) was followed by 3 months of reduced use of the monitoring system and case conferences led by an internal registered nurse (Phase II). In the control group, the monitoring system was only used for data acquisition. Nurses reported the activities with a specifically developed tool. Based on the recorded activities, the cost of care was calculated. The correlating reimbursement per patient was calculated from the care levels in the Swiss reimbursement system. Data from 44 residents was included in the analysis with a linear mixed model. Although analysis revealed no statistically significant effects, results indicate that the use of a monitoring system can guide nurses in organizing their tasks to increase effectiveness. Information systems such as the mobility monitor can help to identify single outliers that do not correspond with the overall situation. In the health care system, problematic individual cases can account for a disproportionally high cost levels. It was shown that information systems can have a significant economic impact in the long run. The study is registered at the German Clinical Trials Register under the Nr. DRKS00006829 .

A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities

PubMed Central

Chow, Susan Ka Yee; Wong, Frances Kam Yuet

2014-01-01

Aim To examine the effects of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. Background The most significant chronic conditions today involve diseases of the cardiovascular, respiratory, endocrine and renal systems. Previous studies have suggested that a nurse-led case management approach using either telephone follow-ups or home visits was able to improve clinical and patient outcomes for patients having a single, chronic disease, while the effects for older patients having at least two long-term conditions are unknown. A self-help programme using motivation and empowerment approaches is the framework of care in the study. Design Randomized controlled trial. Method The study was conducted from 2010–2012. Older patients having at least two chronic diseases were included for analysis. The participants were randomized into three arms: two study groups and one control group. Data were collected at baseline and at 4 and 12 weeks later. Results Two hundred and eighty-one patients completed the study. The interventions demonstrated significant differences in hospital readmission rates within 84 days post discharge. The two intervention groups had lower readmission rates than the control group. Patients in the two study arms had significantly better self-rated health and self-efficacy. There was significant difference between the groups in the physical composite score, but no significant difference in mental component score in SF-36 scale. Conclusion The postdischarge interventions led by the nurse case managers on self-management of disease using the empowerment approach were able to provide effective clinical and patient outcomes for older patients having co-morbidities. PMID:24617755

Genetic variation in the ADIPOQ gene, adiponectin concentrations and risk of colorectal cancer: a Mendelian Randomization analysis using data from three large cohort studies.

PubMed

Nimptsch, Katharina; Song, Mingyang; Aleksandrova, Krasimira; Katsoulis, Michail; Freisling, Heinz; Jenab, Mazda; Gunter, Marc J; Tsilidis, Konstantinos K; Weiderpass, Elisabete; Bueno-De-Mesquita, H Bas; Chong, Dawn Q; Jensen, Majken K; Wu, Chunsen; Overvad, Kim; Kühn, Tilman; Barrdahl, Myrto; Melander, Olle; Jirström, Karin; Peeters, Petra H; Sieri, Sabina; Panico, Salvatore; Cross, Amanda J; Riboli, Elio; Van Guelpen, Bethany; Myte, Robin; Huerta, José María; Rodriguez-Barranco, Miguel; Quirós, José Ramón; Dorronsoro, Miren; Tjønneland, Anne; Olsen, Anja; Travis, Ruth; Boutron-Ruault, Marie-Christine; Carbonnel, Franck; Severi, Gianluca; Bonet, Catalina; Palli, Domenico; Janke, Jürgen; Lee, Young-Ae; Boeing, Heiner; Giovannucci, Edward L; Ogino, Shuji; Fuchs, Charles S; Rimm, Eric; Wu, Kana; Chan, Andrew T; Pischon, Tobias

2017-05-01

Higher levels of circulating adiponectin have been related to lower risk of colorectal cancer in several prospective cohort studies, but it remains unclear whether this association may be causal. We aimed to improve causal inference in a Mendelian Randomization meta-analysis using nested case-control studies of the European Prospective Investigation into Cancer and Nutrition (EPIC, 623 cases, 623 matched controls), the Health Professionals Follow-up Study (HPFS, 231 cases, 230 controls) and the Nurses' Health Study (NHS, 399 cases, 774 controls) with available data on pre-diagnostic adiponectin concentrations and selected single nucleotide polymorphisms in the ADIPOQ gene. We created an ADIPOQ allele score that explained approximately 3% of the interindividual variation in adiponectin concentrations. The ADIPOQ allele score was not associated with risk of colorectal cancer in logistic regression analyses (pooled OR per score-unit unit 0.97, 95% CI 0.91, 1.04). Genetically determined twofold higher adiponectin was not significantly associated with risk of colorectal cancer using the ADIPOQ allele score as instrumental variable (pooled OR 0.73, 95% CI 0.40, 1.34). In a summary instrumental variable analysis (based on previously published data) with higher statistical power, no association between genetically determined twofold higher adiponectin and risk of colorectal cancer was observed (0.99, 95% CI 0.93, 1.06 in women and 0.94, 95% CI 0.88, 1.01 in men). Thus, our study does not support a causal effect of circulating adiponectin on colorectal cancer risk. Due to the limited genetic determination of adiponectin, larger Mendelian Randomization studies are necessary to clarify whether adiponectin is causally related to lower risk of colorectal cancer.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative.

PubMed

Barchi, Francis H; Kasimatis-Singleton, Megan; Kasule, Mary; Khulumani, Pilate; Merz, Jon F

2013-02-01

Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Completion of the case-based intervention improved respondents' test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate.

Building research capacity in Botswana: a randomized trial comparing training methodologies in the Botswana ethics training initiative

PubMed Central

2013-01-01

Background Little empirical data are available on the extent to which capacity-building programs in research ethics prepare trainees to apply ethical reasoning skills to the design, conduct, or review of research. A randomized controlled trial was conducted in Botswana in 2010 to assess the effectiveness of a case-based intervention using email to augment in-person seminars. Methods University faculty and current and prospective IRB/REC members took part in a semester-long training program in research ethics. Participants attended two 2-day seminars and were assigned at random to one of two on-line arms of the trial. Participants in both arms completed on-line international modules from the Collaborative Institutional Training Initiative. Between seminars, intervention-arm participants were also emailed a weekly case to analyze in response to set questions; responses and individualized faculty feedback were exchanged via email. Tests assessing ethics knowledge were administered at the start of each seminar. The post-test included an additional section in which participants were asked to identify the ethical issues highlighted in five case studies from a list of multiple-choice responses. Results were analyzed using regression and ANOVA. Results Of the 71 participants (36 control, 35 intervention) enrolled at the first seminar, 41 (57.7%) attended the second seminar (19 control, 22 intervention). In the intervention arm, 19 (54.3%) participants fully completed and 8 (22.9%) partially completed all six weekly cases. The mean score was higher on the post-test (30.3/40) than on the pre-test (28.0/40), and individual post- and pre-test scores were highly correlated (r = 0.65, p < 0.0001). Group assignment alone did not have an effect on test scores (p > 0.84), but intervention-arm subjects who completed all assigned cases answered an average of 3.2 more questions correctly on the post-test than others, controlling for pre-test scores (p = 0.003). Conclusions Completion of the case-based intervention improved respondents’ test scores, with those who completed all six email cases scoring roughly 10% better than those who failed to complete this task and those in the control arm. There was only suggestive evidence that intensive case work improved ethical issue identification, although there was limited ability to assess this outcome due to a high drop-out rate. PMID:23368699

Case-Control Study of Injury Intervention for Preschool Children in Henggang, Shenzhen.

PubMed

Wang, Hong; Liu, Yi-Xin; Deng, Wen-Jiao; Yang, Wei-Jian; Wang, Fang

2015-10-01

To explore effective interventions for child accidental injury prevention and to reduce the incidence of injury. Cluster random sampling method was adopted, and children in 19 kindergartens in Henggang, Shenzhen and their parents were selected as the objects of study. Nineteen kindergartens were randomly divided into intervention group and control group to carry out the injury intervention case-control study. Through a series of interventions, there were certain effects. After the end of the project, the injury incidence rates of the intervention group and the control group were 4.91%, 10.64%, and the difference was significant; the average costs of treatment for injuries of the intervention group and the control group were 168.4 Yuan and 206.8 Yuan, and the difference was statistically significant; compared with before the implementation of the project, the rate of various types of injuries after the end of the project declined, in which, the rate of mechanical injury, pet bites, accidental falls, burns, and traffic accidents decreased significantly. The differences were significant. Injury interventions can effectively prevent and control the occurrence of injury.

Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy.

PubMed

Cohen, Jonathan; Cohen, Seth A; Vora, Kinjal C; Xue, Xiaonan; Burdick, J Steven; Bank, Simmy; Bini, Edmund J; Bodenheimer, Henry; Cerulli, Maurice; Gerdes, Hans; Greenwald, David; Gress, Frank; Grosman, Irwin; Hawes, Robert; Mullin, Gerard; Mullen, Gerard; Schnoll-Sussman, Felice; Starpoli, Anthony; Stevens, Peter; Tenner, Scott; Villanueva, Gerald

2006-09-01

The GI Mentor is a virtual reality simulator that uses force feedback technology to create a realistic training experience. To define the benefit of training on the GI Mentor on competency acquisition in colonoscopy. Randomized, controlled, blinded, multicenter trial. Academic medical centers with accredited gastroenterology training programs. First-year GI fellows. Subjects were randomized to receive 10 hours of unsupervised training on the GI Mentor or no simulator experience during the first 8 weeks of fellowship. After this period, both groups began performing real colonoscopies. The first 200 colonoscopies performed by each fellow were graded by proctors to measure technical and cognitive success, and patient comfort level during the procedure. A mixed-effects model comparison between the 2 groups of objective and subjective competency scores and patient discomfort in the performance of real colonoscopies over time. Forty-five fellows were randomized from 16 hospitals over 2 years. Fellows in the simulator group had significantly higher objective competency rates during the first 100 cases. A mixed-effects model demonstrated a higher objective competence overall in the simulator group (P < .0001), with the difference between groups being significantly greater during the first 80 cases performed. The median number of cases needed to reach 90% competency was 160 in both groups. The patient comfort level was similar. Fellows who underwent GI Mentor training performed significantly better during the early phase of real colonoscopy training.

Correcting Classifiers for Sample Selection Bias in Two-Phase Case-Control Studies

PubMed Central

Theis, Fabian J.

2017-01-01

Epidemiological studies often utilize stratified data in which rare outcomes or exposures are artificially enriched. This design can increase precision in association tests but distorts predictions when applying classifiers on nonstratified data. Several methods correct for this so-called sample selection bias, but their performance remains unclear especially for machine learning classifiers. With an emphasis on two-phase case-control studies, we aim to assess which corrections to perform in which setting and to obtain methods suitable for machine learning techniques, especially the random forest. We propose two new resampling-based methods to resemble the original data and covariance structure: stochastic inverse-probability oversampling and parametric inverse-probability bagging. We compare all techniques for the random forest and other classifiers, both theoretically and on simulated and real data. Empirical results show that the random forest profits from only the parametric inverse-probability bagging proposed by us. For other classifiers, correction is mostly advantageous, and methods perform uniformly. We discuss consequences of inappropriate distribution assumptions and reason for different behaviors between the random forest and other classifiers. In conclusion, we provide guidance for choosing correction methods when training classifiers on biased samples. For random forests, our method outperforms state-of-the-art procedures if distribution assumptions are roughly fulfilled. We provide our implementation in the R package sambia. PMID:29312464

An open randomized controlled study comparing an online text-based scenario and a serious game by Belgian and Swiss pharmacy students.

PubMed

Berger, Jérôme; Bawab, Noura; De Mooij, Jeremy; Sutter Widmer, Denise; Szilas, Nicolas; De Vriese, Carine; Bugnon, Olivier

2018-03-01

To compare online learning tools, looped, branch serious game (SG) and linear text-based scenario (TBS), among a sample of Belgian and Swiss pharmacy students. Open randomized controlled study. The lesson was based on the case of a benign cough in a healthy child. A randomized sample of 117 students: only the Swiss students had attended a previous lecture on coughs. Participation rate, pre- and post-experience Likert scales and students' clinical knowledge were measured. Our primary hypothesis was demonstrated: students favored the SG even if navigation was rated as more complex, and students who performed the SG better understood the aim of pharmacist triage in case of cough. The influence of the SG appeared to be linked to the presence of a previous lecture in the curriculum. SG and TBS are effective to teach pharmacist triage. Higher SG complexity should be used to teach the aim of pharmacist triage in the case of a specific disease and could be an alternative to simulated patients. A simpler TBS does not require a previous lecture and a debriefing to be fully effective. Copyright © 2017 Elsevier Inc. All rights reserved.

Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM)

PubMed Central

Adler, Ubiratan C.; Krüger, Stephanie; Teut, Michael; Lüdtke, Rainer; Schützler, Lena; Martins, Friederike; Willich, Stefan N.; Linde, Klaus; Witt, Claudia M.

2013-01-01

Background The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. Aims To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. Methods A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. Results A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI −1.2;5.2) for Q-potencies vs. placebo and −3.1 (−5.9;−0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. Conclusions Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Trial registration clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43 PMID:24086352

Complementary physical therapies for movement disorders in Parkinson's disease: a systematic review.

PubMed

Alves Da Rocha, P; McClelland, J; Morris, M E

2015-12-01

The growth and popularity of complementary physical therapies for Parkinson's disease (PD) attempt to fill the gap left by conventional exercises, which does not always directly target wellbeing, enjoyment and social participation. To evaluate the effects of complementary physical therapies on motor performance, quality of life and falls in people living with PD. Systematic review with meta-analysis. Outpatients--adults diagnosed with idiopathic PD, male or female, modified Hoehn and Yahr scale I-IV, any duration of PD, any duration of physical treatment or exercise. Randomized controlled trials, non-randomized controlled trials and case series studies were identified by systematic searching of health and rehabilitation electronic databases. A standardized form was used to extract key data from studies by two independent researchers. 1210 participants from 20 randomized controlled trials, two non-randomized controlled trials and 13 case series studies were included. Most studies had moderately strong methodological quality. Dancing, water exercises and robotic gait training were an effective adjunct to medical management for some people living with PD. Virtual reality training, mental practice, aerobic training, boxing and Nordic walking training had a small amount of evidence supporting their use in PD. On balance, alternative physical therapies are worthy of consideration when selecting treatment options for people with this common chronic disease. Complementary physical therapies such as dancing, hydrotherapy and robotic gait training appear to afford therapeutic benefits, increasing mobility and quality of life, in some people living with PD.

The Misconception of Case-Control Studies in the Plastic Surgery Literature: A Literature Audit.

PubMed

Hatchell, Alexandra C; Farrokhyar, Forough; Choi, Matthew

2017-06-01

Case-control study designs are commonly used. However, many published case-control studies are not true case-controls and are in fact mislabeled. The purpose of this study was to identify all case-control studies published in the top three plastic surgery journals over the past 10 years, assess which were truly case-control studies, clarify the actual design of the articles, and address common misconceptions. MEDLINE, Embase, and Web of Science databases were searched for case-control studies in the three highest-impact factor plastic surgery journals (2005 to 2015). Two independent reviewers screened the resulting titles, abstracts, and methods, if applicable, to identify articles labeled as case-control studies. These articles were appraised and classified as true case-control studies or non-case-control studies. The authors found 28 articles labeled as case-control studies. However, only six of these articles (21 percent) were truly case-control designs. Of the 22 incorrectly labeled studies, one (5 percent) was a randomized controlled trial, three (14 percent) were nonrandomized trials, two (9 percent) were prospective comparative cohort designs, 14 (64 percent) were retrospective comparative cohort designs, and two (9 percent) were cross-sectional designs. The mislabeling was worse in recent years, despite increases in evidence-based medicine awareness. The majority of published case-control studies are not in fact case-control studies. This misunderstanding is worsening with time. Most of these studies are actually comparative cohort designs. However, some studies are truly clinical trials and thus a higher level of evidence than originally proposed.

The development of the deterministic nonlinear PDEs in particle physics to stochastic case

NASA Astrophysics Data System (ADS)

Abdelrahman, Mahmoud A. E.; Sohaly, M. A.

2018-06-01

In the present work, accuracy method called, Riccati-Bernoulli Sub-ODE technique is used for solving the deterministic and stochastic case of the Phi-4 equation and the nonlinear Foam Drainage equation. Also, the control on the randomness input is studied for stability stochastic process solution.

Wenxin Keli versus Sotalol for Paroxysmal Atrial Fibrillation Caused by Hyperthyroidism: A Prospective, Open Label, and Randomized Study

PubMed Central

Meng, Zhaowei; Tan, Jian; He, Qing; Zhu, Mei; Li, Xue; Zhang, Jianping; Jia, Qiang; Wang, Shen; Zhang, Guizhi; Zheng, Wei

2015-01-01

We aimed to compare effectiveness of Wenxin Keli (WK) and sotalol in assisting sinus rhythm (SR) restoration from paroxysmal atrial fibrillation (PAF) caused by hyperthyroidism, as well as in maintaining SR. We randomly prescribed WK (18 g tid) or sotalol (80 mg bid) to 91 or 89 patients. Since it was not ethical not to give patients antiarrhythmia drugs, no control group was set. Antithyroid drugs were given to 90 patients (45 in WK group, 45 in sotalol group); 131I was given to 90 patients (46 in WK group, 44 in sotalol group). Three months later, SR was obtained in 83/91 or 80/89 cases from WK or sotalol groups (P = 0.762). By another analysis, SR was obtained in 86/90 or 77/90 cases from 131I or ATD groups (P = 0.022). Then, we randomly assigned the successfully SR-reverted patients into three groups: WK, sotalol, and control (no antiarrhythmia drug was given) groups. After twelve-month follow-up, PAF recurrence happened in 1/54, 2/54, and 9/55 cases, respectively. Log-Rank test showed significant higher PAF recurrent rate in control patients than either treatment (P = 0.06). We demonstrated the same efficacies of WK and sotalol to assist SR reversion from hyperthyroidism-caused PAF. We also showed that either drug could maintain SR in such patients. PMID:26074982

Long-term survival after traumatic brain injury: a population-based analysis controlled for nonhead trauma.

PubMed

Brown, Allen W; Leibson, Cynthia L; Mandrekar, Jay; Ransom, Jeanine E; Malec, James F

2014-01-01

To examine the contribution of co-occurring nonhead injuries to hazard of death after traumatic brain injury (TBI). A random sample of Olmsted County, Minnesota, residents with confirmed TBI from 1987 through 1999 was identified. Each case was assigned an age- and sex-matched, non-TBI "regular control" from the population. For "special cases" with accompanying nonhead injuries, 2 matched "special controls" with nonhead injuries of similar severity were assigned. Vital status was followed from baseline (ie, injury date for cases, comparable dates for controls) through 2008. Cases were compared first with regular controls and second with regular or special controls, depending on case type. In total, 1257 cases were identified (including 221 special cases). For both cases versus regular controls and cases versus regular or special controls, the hazard ratio was increased from baseline to 6 months (10.82 [2.86-40.89] and 7.13 [3.10-16.39], respectively) and from baseline through study end (2.92 [1.74-4.91] and 1.48 [1.09-2.02], respectively). Among 6-month survivors, the hazard ratio was increased for cases versus regular controls (1.43 [1.06-2.15]) but not for cases versus regular or special controls (1.05 [0.80-1.38]). Among 6-month survivors, accounting for nonhead injuries resulted in a nonsignificant effect of TBI on long-term mortality.

Impact of a social franchising program on uptake of oral rehydration solution plus zinc for childhood diarrhea in myanmar: a community-level randomized controlled trial.

PubMed

Aung, Tin; Montagu, Dominic; Su Su Khin, Hnin; Win, Zaw; San, Ang Kyaw; McFarland, Willi

2014-06-01

Diarrhea's impact on childhood morbidity can be reduced by administering oral rehydration solution (ORS) with zinc; challenges to wider use are changing health-seeking behavior and ensuring access. We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar. Village tracts, matched in 52 pairs, were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc. Intervention and control communities were comparable on demographics, prevalence of diarrhea and previous use of ORS. One year after randomization, ORS plus zinc use was 13.7% in the most recent case of diarrhea in intervention households compared with 1.8% in control households (p < 0.001) (N = 3605). A significant increase in ORS plus zinc use was noted in the intervention (p = 0.044) but not in the control (p = 0.315) group. Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar. Scale-up stands to reduce morbidity among children in similar settings. Current Controlled Trials ISRCTN73606238. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study

PubMed Central

Mokhtari, Negar; Shirazi, Alireza-Sarraf

2017-01-01

Background Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. Material and Methods In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests (P<0.05). Results There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files (P=0.000). Conclusions Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words:Rotary technique, conventional technique, pulpectomy, primary teeth. PMID:29302280

A smart rotary technique versus conventional pulpectomy for primary teeth: A randomized controlled clinical study.

PubMed

Mokhtari, Negar; Shirazi, Alireza-Sarraf; Ebrahimi, Masoumeh

2017-11-01

Techniques with adequate accuracy of working length determination along with shorter duration of treatment in pulpectomy procedure seems to be essential in pediatric dentistry. The aim of the present study was to evaluate the accuracy of root canal length measurement with Root ZX II apex locator and rotary system in pulpectomy of primary teeth. In this randomized control clinical trial complete pulpectomy was performed on 80 mandibular primary molars in 80, 4-6-year-old children. The study population was randomly divided into case and control groups. In control group conventional pulpectomy was performed and in the case group working length was determined by electronic apex locator Root ZXII and instrumented with Mtwo rotary files. Statistical evaluation was performed using Mann-Whitney and Chi-Square tests ( P <0.05). There were no significant differences between electronic apex locator Root ZXII and conventional method in accuracy of root canal length determination. However significantly less time was needed for instrumenting with rotary files ( P =0.000). Considering the comparable results in accuracy of root canal length determination and the considerably shorter instrumentation time in Root ZXII apex locator and rotary system, it may be suggested for pulpectomy in primary molar teeth. Key words: Rotary technique, conventional technique, pulpectomy, primary teeth.

Animal-Assisted Therapy for Post-traumatic Stress Disorder: Lessons from "Case Reports" in Media Stories.

PubMed

Altschuler, Eric L

2018-01-01

Post-traumatic stress disorder (PTSD) can follow war trauma, sexual abuse, other traumas, and even be experienced by commanders for the PTSD of their subordinates. Medications and counseling are sometimes not effective, so new treatments are needed. Some years ago, I suggested that animal-assisted therapy (AAT) (pet therapy) might be beneficial for PTSD. A large randomized controlled trial is underway of canine-assisted therapy for PTSD. Randomized controlled trials are most useful in assessing the efficacy of a medical intervention as these trials control for known and unknown biases. However, due to their very nature and rigorous requirements, knowledge gained from randomized controlled trials may need to be supplemented from other kinds of studies. Here, I note that media reports of AAT for PTSD may effectively function as case reports and suggest further studies: For PTSD, these demonstrate that (1) AAT can be dramatically effective in improving PTSD symptoms; (2) there is the potential for benefit from AAT by multiple different animals besides canines for PTSD; and (3) AAT may have a role in preventing suicide in patients with PTSD. © Association of Military Surgeons of the United States 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Tailored educational intervention for primary care to improve the management of dementia: the EVIDEM-ED cluster randomized controlled trial.

PubMed

Wilcock, Jane; Iliffe, Steve; Griffin, Mark; Jain, Priya; Thuné-Boyle, Ingela; Lefford, Frances; Rapp, David

2013-11-20

Early diagnosis of dementia is important because this allows those with dementia and their families to engage support and plan ahead. However, dementia remains underdetected and suboptimally managed in general practice. Our objective was to test the effect of a workplace-based tailored educational intervention developed for general practice on the clinical management of people with dementia. The tailored educational intervention was tested in an unblinded cluster randomized controlled trial with a pre/post-intervention design, with two arms: usual/normal care control versus educational intervention. The primary outcome measure was an increase in the proportion of patients with dementia who received at least two documented dementia-specific management reviews per year. Case identification was a secondary outcome measure. 23 practices in South-East England participated. A total of 1,072 patients with dementia (intervention: 512, control: 560) had information in their medical records showing the number of reviews within 12 months (or a proportion of) before intervention or randomization and within 12 months (or a proportion of) after. The mean total number of dementia management reviews after the educational intervention for people with dementia was 0.89 (SD 1.09; minimum 0; median 1; maximum 8) compared with 0.89 (SD 0.92; minimum 0; median 1; maximum 4) before intervention. In the control group prior to randomization the mean total number of dementia management reviews was 1.66 (SD 1.87; minimum 0; median 1; maximum 12) and in the period after randomization it was 1.56 (SD 1.79; minimum 0; median 1; maximum 11). Case detection rates were unaffected. The estimated incidence rate ratio for intervention versus control group was 1.03 (P = 0.927, 95% CI 0.57 to 1.86). The trial was timely, coinciding with financial incentives for dementia management in general practice (through the Quality Outcomes Framework); legal imperatives (in the form of the Mental Capacity Act 2005); policy pressure (The National Dementia Strategy 2009); and new resources (such as dementia advisors) that increased the salience of dementia for general practitioners. Despite this the intervention did not alter the documentation of clinical management of patients with dementia in volunteer practices, nor did it increase case identification. NCT00866099/Clinical Trials.

Evaluation of a problem-specific SBAR tool to improve after-hours nurse-physician phone communication: a randomized trial.

PubMed

Joffe, Erel; Turley, James P; Hwang, Kevin O; Johnson, Todd R; Johnson, Craig W; Bernstam, Elmer V

2013-11-01

After-hours telephone communications are common in patient management. Patterns of communication of key information during after-hours phone calls were evaluated, and the utility of problem-specific Situation, Background, Assessment, Recommendation (SBAR) forms in improving this communication was assessed. In a randomized trial using a simulated on-call setting, 20 nurses called physicians regarding six cases adapted from inpatient records and based on the six most common reasons for after-hours nurse-physician communication. Three of the cases were handled without the SBAR forms (control cases), and three cases were handled with the forms (SBAR cases). Two cue types of communication were evaluated: situation cues, which conveyed the patient's situation (for example, a patient is confused), and background cues, which conveyed problem-specific data indicated on the SBAR forms (for example, the patient has a low sodium level). Ninety-two phone calls were analyzed (43 SBAR/49 controls). Most of the nurses reported the situation cues (SBAR 88%, control 84%, p = .60) but not the background cues. There was a trend toward fewer background cues communicated in the SBAR cases (14% versus 31%, p = .08). In 14% of the cases, on average, nurses omitted information or reported wrong information regarding the background cue. Physicians asked questions that resulted in the communication of the cues in a minority of the cases when the background cues were not originally provided by the nurses (SBAR 6%, control 16%, p = .39). In after-hours phone communication between physicians and nurses, significant information was often not communicated and physicians did not elicit the necessary information. Simply providing an SBAR-based form did not ensure complete communication of key information.

Dual ovarian stimulation and random start in assisted reproductive technologies: from ovarian biology to clinical application.

PubMed

Vaiarelli, Alberto; Venturella, Roberta; Vizziello, Damiano; Bulletti, Francesco; Ubaldi, Filippo M

2017-06-01

The opportunity to use gonadotropins to stimulate the growth of antral follicles coming from different follicular waves available in different moment of the menstrual cycle allowed the implementation of innovative protocols in assisted reproductive technologies. The purpose of this review is to explore the possible advantages related to these new controlled ovarian stimulation (COS) strategies. Women exhibit major and minor wave patterns of ovarian follicular development during the menstrual cycle, as it is in animal species. These observations led to the introduction of two new strategies for COS: the random start and the double ovarian stimulation within a single menstrual cycle. The use of gonadotropin-releasing hormone antagonist COS protocols, started randomly at any day of the menstrual cycle, is today a standard procedure in those cases where obtaining oocytes is an urgent task, such as in case of fertility preservation for malignant diseases or other medical indications.On the other hand, in poor prognosis patients, double ovarian stimulation has been suggested with the aim of maximizing the number of oocytes retrieved within a single menstrual cycle and, in turn increasing the chance to obtain a reproductively competent embryo. Randomized control trials are necessary to confirm these preliminary findings.

Theory of "laser distillation" of enantiomers: purification of a racemic mixture of randomly oriented dimethylallene in a collisional environment.

PubMed

Gerbasi, David; Shapiro, Moshe; Brumer, Paul

2006-02-21

Enantiomeric control of 1,3 dimethylallene in a collisional environment is examined. Specifically, our previous "laser distillation" scenario wherein three perpendicular linearly polarized light fields are applied to excite a set of vib-rotational eigenstates of a randomly oriented sample is considered. The addition of internal conversion, dissociation, decoherence, and collisional relaxation mimics experimental conditions and molecular decay processes. Of greatest relevance is internal conversion which, in the case of dimethylallene, is followed by molecular dissociation. For various rates of internal conversion, enantiomeric control is maintained in this scenario by a delicate balance between collisional relaxation of excited dimethylallene that enhances control and collisional dephasing, which diminishes control.

Assessing the Effectiveness of Case-Based Collaborative Learning via Randomized Controlled Trial.

PubMed

Krupat, Edward; Richards, Jeremy B; Sullivan, Amy M; Fleenor, Thomas J; Schwartzstein, Richard M

2016-05-01

Case-based collaborative learning (CBCL) is a novel small-group approach that borrows from team-based learning principles and incorporates elements of problem-based learning (PBL) and case-based learning. CBCL includes a preclass readiness assurance process and case-based in-class activities in which students respond to focused, open-ended questions individually, discuss their answers in groups of 4, and then reach consensus in larger groups of 16. This study introduces CBCL and assesses its effectiveness in one course at Harvard Medical School. In a 2013 randomized controlled trial, 64 medical and dental student volunteers were assigned randomly to one of four 8-person PBL tutorial groups (control; n = 32) or one of two 16-person CBCL tutorial groups (experimental condition; n = 32) as part of a required first-year physiology course. Outcomes for the PBL and CBCL groups were compared using final exam scores, student responses to a postcourse survey, and behavioral coding of portions of video-recorded class sessions. Overall, the course final exam scores for CBCL and PBL students were not significantly different. However, CBCL students whose mean exam performance in prior courses was below the participant median scored significantly higher than their PBL counterparts on the physiology course final exam. The most common adjectives students used to describe CBCL were "engaging," "fun," and "thought-provoking." Coding of observed behaviors indicated that individual affect was significantly higher in the CBCL groups than in the PBL groups. CBCL is a viable, engaging, active learning method. It may particularly benefit students with lower academic performance.

Corticosteroid Injection for the Treatment of Morton's Neuroma: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial.

PubMed

Lizano-Díez, Xavier; Ginés-Cespedosa, Alberto; Alentorn-Geli, Eduard; Pérez-Prieto, Daniel; González-Lucena, Gemma; Gamba, Carlo; de Zabala, Santiago; Solano-López, Alberto; Rigol-Ramón, Pau

2017-09-01

The effectiveness of corticosteroid injection for the treatment of Morton's neuroma is unclear. In addition, most of the studies related to it are case-control or retrospective case series. The purpose of this study was to compare the effectiveness between corticosteroid injection associated with local anesthetic and local anesthetic alone (placebo control group) for the treatment of Morton's neuroma. Forty-one patients with a diagnosis of Morton's neuroma were randomized to receive 3 injections of either a corticosteroid plus a local anesthetic or a local anesthetic alone. The patients and the researcher who collected data were blinded to the treatment groups. The visual analog scale for pain and the American Orthopaedic Foot & Ankle Score (metatarsophalangeal/interphalangeal score) were obtained at baseline, after each injection, and at 3 and 6 months after the last injection. There were no significant between-group differences in terms of pain and function improvement at 3 and 6 months after treatment completion in comparison with baseline values. At the end of the study, 17 (48.5%) patients requested surgical excision of the neuroma: 7 (44%) in the experimental group and 10 (53%) in the control group ( P = 1.0). The injection of a corticosteroid plus a local anesthetic was not superior to a local anesthetic alone in terms of pain and function improvement in patients with Morton's neuroma. Level I, randomized controlled trial.

Bridging glycated hemoglobin with quality of life and health state; a randomized case-control study among type 2 diabetes patients.

PubMed

Gillani, Syed Wasif; Ansari, Irfan Altaf; Zaghloul, Hisham A; Abdul, Mohi Iqbal Mohammad; Sulaiman, Syed Azhar Syed; Baig, Mirza R

2018-01-01

The aim of this study was to explore the predictors of QOL and health state and examine the relationship with glycemic control among type 2 diabetes mellitus (T2DM) patients. A randomized cross-sectional case-control study was conducted among n = 600 T2DM patients of Malaysia. Study population was distributed into three groups as: controls: patients with HbA1c ≤ 7 (n = 199), cases arm 1: with HbA1c 7-7.9 (n = 204) and cases arm 2 (n = 197): with HbA1c ≥ 8 consecutively last 3 times. Participants with diabetes history > 10 years exhibits higher mean QOL score among all the three groups. In contrast mean health status score significantly ( p  < 0.001) reduced with the exposure duration of diabetes both within and intergroup assessment that participants with poor glycemic control (arm 2) had significantly higher mean QOL score with knowledge and self-care dimensions as compared to others, however mean health state scores were significantly ( p  < 0.001) lower in all assessment dimensions as compared to controls. The F test of significance showed that demographic and clinical parameters were strong predictors of QOL, whereas self-care activities, comorbidities, ability of positive management and BMI were significant predictors to health state for consistent glycemic control (controls) as compared to poor glycemic control (arm 2) participants. This study suggested that poor glycemic index reported low self-care behavior, increase barriers to daily living activities and poor ability to manage diabetes positively, which cause poor QOL and decrease health state.

Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multicenter Trial

DTIC Science & Technology

2014-04-01

randomization design, after all patients are treated with dermal matrix, patients will be randomized to Arm 1 (control group; standard skin grafting with... grafts are often “meshed” or flattened and spread out to increase the size of the skin graft to better cover a large wound. Standard “meshing” increases...the size of the donor graft by 1.5 times (1:1.5). Problems with healing and skin irritation remain with such skin grafts when the injured areas are

Waiting list randomized controlled trial within a case-finding design: methodological considerations.

PubMed

Ronaldson, Sarah; Adamson, Joy; Dyson, Lisa; Torgerson, David

2014-10-01

Randomized controlled trials (RCTs) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention. However, sometimes a study does not require an RCT in order to answer its primary objective; a case-finding design may be more appropriate. The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study. An example of the new study design is the DOC Study, which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease. It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design. The first step of the study design is to obtain participants' consent. Individuals are then randomized to one of two groups; either the 'intervention now' group or the 'intervention later' group, that is, participants are placed on a waiting list. All participants receive the same intervention; the only difference between the groups is the timing of the intervention. The design addresses patient preference issues and recruitment issues that can arise in other trial designs. Potential limitations include differential attrition between study groups and potential demoralization for the 'intervention later' group. The 'waiting list case-finding trial' design is a valuable method that could be applied to case-finding studies; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial. © 2014 John Wiley & Sons, Ltd.

[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

PubMed

Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg -1 , Group C getting clonidine 1mcg.kg -1 and Group D patients receiving dexmedetomidine 0.5mcg.kg -1 . The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Validity and power of association testing in family-based sampling designs: evidence for and against the common wisdom.

PubMed

Knight, Stacey; Camp, Nicola J

2011-04-01

Current common wisdom posits that association analyses using family-based designs have inflated type 1 error rates (if relationships are ignored) and independent controls are more powerful than familial controls. We explore these suppositions. We show theoretically that family-based designs can have deflated type-error rates. Through simulation, we examine the validity and power of family designs for several scenarios: cases from randomly or selectively ascertained pedigrees; and familial or independent controls. Family structures considered are as follows: sibships, nuclear families, moderate-sized and extended pedigrees. Three methods were considered with the χ(2) test for trend: variance correction (VC), weighted (weights assigned to account for genetic similarity), and naïve (ignoring relatedness) as well as the Modified Quasi-likelihood Score (MQLS) test. Selectively ascertained pedigrees had similar levels of disease enrichment; random ascertainment had no such restriction. Data for 1,000 cases and 1,000 controls were created under the null and alternate models. The VC and MQLS methods were always valid. The naïve method was anti-conservative if independent controls were used and valid or conservative in designs with familial controls. The weighted association method was generally valid for independent controls, and was conservative for familial controls. With regard to power, independent controls were more powerful for small-to-moderate selectively ascertained pedigrees, but familial and independent controls were equivalent in the extended pedigrees and familial controls were consistently more powerful for all randomly ascertained pedigrees. These results suggest a more complex situation than previously assumed, which has important implications for study design and analysis. © 2011 Wiley-Liss, Inc.

Randomized controlled trial of stereotactic 11-G vacuum-assisted core biopsy for the diagnosis and management of mammographic microcalcification

PubMed Central

Maxwell, Anthony J; Morris, Julie; Lim, Yit Y; Harake, MD Janick; Whiteside, Sigrid

2016-01-01

Objective: To compare the accuracy of 11-G vacuum-assisted biopsy (VAB) with 14-G core needle biopsy (CNB) to diagnose mammographic microcalcification (MM) and effect on surgical outcomes. Methods: Following ethical approval, VAB and CNB (control) were compared in a randomized prospective study for first-line diagnosis of MM and subsequent surgical outcomes in two breast-screening units. Participants gave written informed consent. Exclusions included comorbidity precluding surgery, prior ipsilateral breast cancer and lesions >40 mm requiring mastectomy as first surgical procedure. The final pathological diagnosis was compared with the initial biopsy result. Quality-of-life (QOL) questionnaires were administered at baseline, 2, 6 and 12 months. 110 participants were required to show a 25% improvement in diagnosis with VAB compared with CNB (90% power). Results: Eligibility was assessed for 787 cases; 129 females recalled from the National Health Service breast screening programme were randomized. Diagnostic accuracy of VAB was 86% and that of CNB was 84%. Using VAB, 2/14 (14.3%) cases upgraded from ductal carcinoma in situ to invasion at surgery and 3/19 (15.8%) using CNB. Following VAB 7/16 (44%) cases required repeat surgery vs 7/24 (29%) after CNB. Both groups recorded significant worsening of functional QOL measures and increased breast pain at follow-up. Conclusion: VAB and CNB were equally accurate at diagnosing MM, and no significant differences in surgical outcomes were observed. Advances in knowledge: The first randomized controlled study of VAB for diagnosis of microcalcification using digital mammography showed no difference in diagnostic accuracy of VAB and CNB, or in the proportion of participants needing repeat non-operative biopsy or second therapeutic operation to treat malignancy. PMID:26654214

Environmental Exposures, Genetic Polymorphisms and p53 Mutational Spectra in a Case-Control Study of Breast Cancer

DTIC Science & Technology

1999-01-01

potential benefits of serotonin reuptake inhibitors in X1 tests were performed to evaluate associations of 5-HTT smoking cessation (15) suggested... dogs , sausages, bacon and cold diet assessment instrument used is a well-established tool for cuts was also assessed. A poultry index included...Controls were frequency-matched to cases on age and county. The listing of licensed New York State drivers was used for random selection of women

Exploring the Effectiveness of a Virtual Learning Methodology in Occupational Therapy Education

ERIC Educational Resources Information Center

Bebeau, Deborah

2016-01-01

This quantitative, randomly controlled study sought to find relationships between occupational therapy students' participation in a virtual situated-case scenario (VSCS) and enhanced perceived self-efficacy as well as academic performance when compared to participation in a text-based case study. To determine effects of participation in a virtual…

Forty-two cases of greater occipital neuralgia treated by acupuncture plus acupoint-injection.

PubMed

Pan, Changqing; Tan, Guangbo

2008-09-01

To observe the therapeutic effect of acupuncture plus acupoint-injection on greater occipital neuralgia. The 84 cases of greater occipital neuralgia were randomly divided into two groups, with 42 cases in the treatment group treated by acupuncture plus acupoint-injection, and 42 cases in the control group treated with oral administration of carbamazepine. The total effective rate was 92.8% in the treatment group and 71.4% in the control group. The difference in the total effective rate was significant (P < 0.05) between the two groups. Acupuncture plus acupoint-injection is effective for greater occipital neuralgia, better than the routine western medication.

Case management to increase quality of life after cancer treatment: a randomized controlled trial.

PubMed

Scherz, Nathalie; Bachmann-Mettler, Irène; Chmiel, Corinne; Senn, Oliver; Boss, Nathalie; Bardheci, Katarina; Rosemann, Thomas

2017-03-28

Case management has been shown to be beneficial in phases of cancer screening and treatment. After treatment is completed, patients experience a loss of support due to reduced contact with medical professionals. Case management has the potential to offer continuity of care and ease re-entry to normal life. We therefore aim to investigate the effect of case management on quality of life in early cancer survivors. Between 06/2010 and 07/2012, we randomized 95 patients who had just completed cancer treatment in 11 cancer centres in the canton of Zurich, Switzerland. Patients in the case management group met with a case manager at least three times over 12 months. Patient-reported outcomes were assessed after 3, 6 and 12 months using the Functional Assessment of Cancer Therapy (FACT-G) scale, the Patient Assessment of Chronic Illness Care (PACIC) and the Self-Efficacy scale. The change in FACT-G over 12 months was significantly greater in the case management group than in the control group (16.2 (SE 2.0) vs. 9.2 (SE 1.5) points, P = 0.006). The PACIC score increased by 0.20 (SE 0.14) in the case management group and decreased by 0.29 (SE 0.12) points in the control group (P = 0.009). Self-Efficacy increased by 3.1 points (SE 0.9) in the case management group and by 0.7 (SE 0.8) points in the control group (P = 0.049). Case management has the potential to improve quality of life, to ease re-entry to normal life and to address needs for continuity of care in early cancer survivors. The study has been submitted to the ISRCTN register under the name "Case Management in Oncology Rehabilitation" on the 12th of October 2010 and retrospectively registered under the number ISRCTN41474586 on the 24th of November 2010.

Evaluating the use of friend or family controls in epidemiologic case-control studies.

PubMed

Zhong, Charlie; Cockburn, Myles; Cozen, Wendy; Voutsinas, Jenna; Lacey, James V; Luo, Jianning; Sullivan-Halley, Jane; Bernstein, Leslie; Wang, Sophia S

2017-02-01

Traditional methodologies for identifying and recruiting controls in epidemiologic case-control studies, such as random digit dialing or neighborhood walk, suffer from declining response rates. Here, we revisit the feasibility and comparability of using alternative sources of controls, specifically friend and family controls. We recruited from a recently completed case-control study of non-Hodgkin lymphoma (NHL) among women in Los Angeles County where controls from the parent study were ascertained by neighborhood walk. We calculated participation rates and compared questionnaire responses between the friend/family controls and the original matched controls from the parent study. Of the 182 NHL case patients contacted, 111 (61%) agreed to participate in our feasibility study. 70 (63%) provided contact information for potential friend and/or family member controls. We were able to successfully contact and recruit a friend/family member for 92% of the case patients. This represented 46 friend controls and 54 family controls. Family controls significantly differed from original matched controls by sex and household income. Other characteristics were similar between friend controls and the original study's neighborhood controls. The apparent comparability of neighborhood controls to friend and family controls among respondents in this study suggests that these alternative methods of control identification can serve as a complementary source of eligible controls in epidemiologic case-control studies. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The incidence of infants with rotavirus enteritis combined with lactose intolerance.

PubMed

Hu, Yulian; Gui, Linyan; Chang, Jing; Liu, Jingyan; Xu, Shuling; Deng, Caiyan; Yu, Fengqin; Ma, Zhanmin; Wang, Guangzhou; Zhang, Changjun

2016-01-01

This study was to research the incidence of infants with rotavirus enteritis combined with lactose intolerance and the clinical effect of low lactose milk powder for infantile rotavirus enteritis with lactose intolerance. The control groups were 126 cases of infants with diarrhea randomly collected from our hospital at the same period, which their rotavirus detection was negative. The observation group was 185 cases of infants with rotavirus, which was tested to be positive. Through the urine galactose determination, 62 cases of the control group were positive and 124 cases of the observation group were positive. Then 124 cases of infants with rotavirus combined with lactose intolerance were randomly divided into two groups. 60 cases in the control group were given rehydration, correction of acidosis, oral smecta, Intestinal probiotics and other conventional treatment, then continued to the original feeding method. While, 64 cases in the treatment group, on the basis of routine treatment, applied the low lactose milk feeding. To observe the total effective rate for the two groups. The incidence of lactose intolerance in children with rotavirus enteritis (67.03%) was significantly higher than that of children with diarrhea (49.2%), which was tested to be negative. And the difference was statistically significant (p<0.5). In the aspect of reducing the frequency of diarrhea, and diarrhea stool forming time, the treatment group has the obvious superiority. The total effective rate was 95.4% for treatment group, which was higher than that in the control group (76.7%), the difference was statistically significant (P<0.05). Infants with rotavirus enteritis was easier to merge with lactose intolerance. The low lactose milk powder could improve the therapeutic effectively and could reduce the duration of disease, and restored to normal diet for 2 weeks feeding time.

Random Measurement Error Does Not Bias the Treatment Effect Estimate in the Regression-Discontinuity Design. II. When an Interaction Effect Is Present.

ERIC Educational Resources Information Center

Trochim, William M. K.; And Others

1991-01-01

The regression-discontinuity design involving a treatment interaction effect (TIE), pretest-posttest functional form specification, and choice of point-of-estimation of the TIE are examined. Formulas for controlling the magnitude of TIE in simulations can be used for simulating the randomized experimental case where estimation is not at the…

Screening for asymptomatic bacteriuria in adults: evidence for the U.S. Preventive Services Task Force reaffirmation recommendation statement.

PubMed

Lin, Kenneth; Fajardo, Kevin

2008-07-01

Asymptomatic bacteriuria is common, and screening for this condition in pregnant women is a well-established, evidence-based standard of current medical practice. Screening other groups of adults has not been shown to improve outcomes. To review new and substantial evidence on screening for asymptomatic bacteriuria, to support the work of the U.S. Preventive Services Task Force. English-language studies of adults (age >18 years) indexed in PubMed and the Cochrane Library and published from 1 January 2002 through 30 April 2007. For benefits of screening or treatment for screened populations, systematic reviews; meta-analyses; and randomized, controlled trials were included. For harms of screening, systematic reviews; meta-analyses; randomized, controlled trials; cohort studies; case-control studies; and case series of large multisite databases were included. Two reviewers independently reviewed titles, abstracts, and full articles for inclusion. Two reviewers extracted data from studies on benefits of screening and treatment (including decreases in the incidence of adverse maternal and fetal outcomes, symptomatic urinary tract infections, hypertension, and renal function decline). An updated Cochrane systematic review of 14 randomized, controlled trials of treatment supports screening for asymptomatic bacteriuria in pregnant women. A randomized, controlled trial and a prospective cohort study show that screening nonpregnant women with diabetes for asymptomatic bacteriuria is unlikely to produce benefits. No new evidence on screening men for asymptomatic bacteriuria or on harms of screening was found. The focused search strategy may have missed some smaller studies on the benefits and harms of screening for asymptomatic bacteriuria. The available evidence continues to support screening for asymptomatic bacteriuria in pregnant women, but not in other groups of adults.

The case-control design in veterinary sciences: A survey.

PubMed

Cullen, Jonah N; Sargeant, Jan M; Makielski, Kelly M; O'Connor, Annette M

2016-11-01

The case-control study design is deceptively simple. However, many design considerations influence the estimated effect measure. An investigation of case-control studies in the human health literature suggested that some of these considerations are not described in reports of case-control studies. Our hypothesis was that the majority of veterinary studies labeled as case-controls would be incident density designs, and many would not interpret the effect measure obtained from those studies as the rate ratio rather than the odds ratio. Reference databases were searched for author-designated case-control studies. A survey of 100 randomly selected studies was conducted to examine the different design options described and estimated effect measures. Of the 100 author-identified case-control studies, 83 assessed an exposure-outcome association and, of those, only 54 (65.1%) sampled the study population based on an outcome and would thus be considered case-control designs. Twelve studies were incidence density designs but none used this terminology. Of the studies that reported an odds ratio as the effect measure, none reported on additional considerations that would have enabled a more interpretable result. This survey indicated many case-control-labeled studies were not case-control designs and among case-control studies, key design aspects were not often described. The absence of information about study design elements and underlying assumptions in case-control studies limits the ability to establish the effect measured by the study and the evidentiary value of the study might be underestimated. Copyright © 2016 Elsevier B.V. All rights reserved.

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

PubMed

Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

2017-10-01

This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

Clinical Inquiry: Is megestrol acetate safe and effective for malnourished nursing home residents?

PubMed

Wen, Frances K; Millar, James; Oberst-Walsh, Linda; Nashelsky, Joan

2018-02-01

No. Megestrol acetate (MA) is neither safe nor effective for stimulating appetite in malnourished nursing home residents. It increases the risk of deep vein thrombosis (strength of recommendation [SOR]: C, 2 retrospective chart reviews), but isn't associated with other new or worsening events or disorders (SOR: B, single randomized controlled trial [RCT]). Over a 25-week period, MA wasn't associated with increased mortality (SOR: B, single RCT). After 44 months, however, MA-treated patients showed decreased median survival (SOR: B, single case-control study). Consistent, meaningful weight gain was not observed with MA treatment (SOR: B, single case-control study, single RCT, 2 retrospective chart reviews, single prospective case-series).

Clustering and phase transitions on a neutral landscape

NASA Astrophysics Data System (ADS)

Scott, Adam D.; King, Dawn M.; Marić, Nevena; Bahar, Sonya

2013-06-01

Recent computational studies have shown that speciation can occur under neutral conditions, i.e., when the simulated organisms all have identical fitness. These works bear comparison with mathematical studies of clustering on neutral landscapes in the context of branching and coalescing random walks. Here, we show that sympatric clustering/speciation can occur on a neutral landscape whose dimensions specify only the simulated organisms’ phenotypes. We demonstrate that clustering occurs not only in the case of assortative mating, but also in the case of asexual fission; it is not observed in the control case of random mating. We find that the population size and the number of clusters undergo a second-order non-equilibrium phase transition as the maximum mutation size is varied.

Case management: a randomized controlled study comparing a neighborhood team and a centralized individual model.

PubMed

Eggert, G M; Zimmer, J G; Hall, W J; Friedman, B

1991-10-01

This randomized controlled study compared two types of case management for skilled nursing level patients living at home: the centralized individual model and the neighborhood team model. The team model differed from the individual model in that team case managers performed client assessments, care planning, some direct services, and reassessments; they also had much smaller caseloads and were assigned a specific catchment area. While patients in both groups incurred very high estimated health services costs, the average annual cost during 1983-85 for team cases was 13.6 percent less than that of individual model cases. While the team cases were 18.3 percent less expensive among "old" patients (patients who entered the study from the existing ACCESS caseload), they were only 2.7 percent less costly among "new" cases. The lower costs were due to reductions in hospital days and home care. Team cases averaged 26 percent fewer hospital days per year and 17 percent fewer home health aide hours. Nursing home use was 48 percent higher for the team group than for the individual model group. Mortality was almost exactly the same for both groups during the first year (about 30 percent), but was lower for team patients during the second year (11 percent as compared to 16 percent). Probable mechanisms for the observed results are discussed.

Advancing Our Understanding of the Etiologies and Mutational Landscapes of Basal Like, Luminal A, and Luminal B Breast Cancers

DTIC Science & Technology

2016-10-01

and luminal B tumors. Our original goal was to recruit about 2,700 women in Western Washington who have been diagnosed with breast cancer to compare...to 900 women who have never been diagnosed with breast cancer, but control ascertainment has been unacceptably low, so on 8/25/15 we submitted a...cases,1800 randomly selected age-matched estrogen receptor positive (ER+) cases, and for comparison, a population-based control group of 900 women

Generation of Stationary Non-Gaussian Time Histories with a Specified Cross-spectral Density

DOE PAGES

Smallwood, David O.

1997-01-01

The paper reviews several methods for the generation of stationary realizations of sampled time histories with non-Gaussian distributions and introduces a new method which can be used to control the cross-spectral density matrix and the probability density functions (pdfs) of the multiple input problem. Discussed first are two methods for the specialized case of matching the auto (power) spectrum, the skewness, and kurtosis using generalized shot noise and using polynomial functions. It is then shown that the skewness and kurtosis can also be controlled by the phase of a complex frequency domain description of the random process. The general casemore » of matching a target probability density function using a zero memory nonlinear (ZMNL) function is then covered. Next methods for generating vectors of random variables with a specified covariance matrix for a class of spherically invariant random vectors (SIRV) are discussed. Finally the general case of matching the cross-spectral density matrix of a vector of inputs with non-Gaussian marginal distributions is presented.« less

Genetically Predicted Body Mass Index and Alzheimer’s Disease Related Phenotypes in Three Large Samples: Mendelian Randomization Analyses

PubMed Central

Mukherjee, Shubhabrata; Walter, Stefan; Kauwe, John S.K.; Saykin, Andrew J.; Bennett, David A.; Larson, Eric B.; Crane, Paul K.; Glymour, M. Maria

2015-01-01

Observational research shows that higher body mass index (BMI) increases Alzheimer’s disease (AD) risk, but it is unclear whether this association is causal. We applied genetic variants that predict BMI in Mendelian Randomization analyses, an approach that is not biased by reverse causation or confounding, to evaluate whether higher BMI increases AD risk. We evaluated individual level data from the AD Genetics Consortium (ADGC: 10,079 AD cases and 9,613 controls), the Health and Retirement Study (HRS: 8,403 participants with algorithm-predicted dementia status) and published associations from the Genetic and Environmental Risk for AD consortium (GERAD1: 3,177 AD cases and 7,277 controls). No evidence from individual SNPs or polygenic scores indicated BMI increased AD risk. Mendelian Randomization effect estimates per BMI point (95% confidence intervals) were: ADGC OR=0.95 (0.90, 1.01); HRS OR=1.00 (0.75, 1.32); GERAD1 OR=0.96 (0.87, 1.07). One subscore (cellular processes not otherwise specified) unexpectedly predicted lower AD risk. PMID:26079416

Zinc supplementation for the prevention of acute lower respiratory infection in children in developing countries: meta-analysis and meta-regression of randomized trials.

PubMed

Roth, Daniel E; Richard, Stephanie A; Black, Robert E

2010-06-01

Routine zinc supplementation is a potential intervention for the prevention of acute lower respiratory infection (ALRI) in developing countries. However, discrepant findings from recent randomized trials remain unexplained. Randomized trials of zinc supplementation in young children in developing countries were identified by a systematic literature review. Trials included in the meta-analysis met specific criteria, including participants <5 years of age, daily/weekly zinc and control supplementation for greater than 3 months, active household surveillance for respiratory morbidity and use of a case definition that included at least one sign of lower respiratory tract illness. ALRI case definitions were classified on the basis of specificity/severity. Incidence rate ratios (IRRs) were pooled by random-effects models. Meta-regression and sub-group analysis were performed to assess potential sources of between-study heterogeneity. Ten trials were eligible for inclusion (n = 49 450 children randomized). Zinc reduced the incidence of ALRI defined by specific clinical criteria [IRR 0.65, 95% confidence interval (CI) 0.52-0.82], but had no effect on lower-specificity ALRI case definitions based on caregiver report (IRR 1.01, 95% CI 0.91-1.12) or World Health Organization 'non-severe pneumonia' (0.96, 95% CI 0.86-1.08). By meta-regression, the effect of zinc was associated with ALRI case definition, but not with mean baseline age, geographic location, nutritional status or zinc dose. Routine zinc supplementation reduced the incidence of childhood ALRI defined by relatively specific clinical criteria, but the effect was null if lower specificity case definitions were applied. The choice of ALRI case definition may substantially influence inferences from community trials regarding the efficacy of preventive interventions.

A Case Study of Team-Initiated Problem Solving Addressing Student Behavior in One Elementary School

ERIC Educational Resources Information Center

Todd, Anne W.; Horner, Robert H.; Berry, Dorothy; Sanders, Carol; Bugni, Michelle; Currier, Allison; Potts, Nicky; Newton, J. Stephen; Algozzine, Bob; Algozzine, Kate

2012-01-01

Team-Initiated Problem Solving (TIPS) is an approach for organizing school team meetings to improve identification of targeted problems, use of data in the development of solutions, and development of implemented action plans. TIPS has been demonstrated in single-case and randomized controlled trial studies to improve the effectiveness of teams to…

Role of re-screening of cervical smears in internal quality control.

PubMed Central

Baker, A; Melcher, D; Smith, R

1995-01-01

AIMS--To investigate the use of rapid re-screening as a quality control method for previously screened cervical slides; to compare this method with 10% random re-screening and clinically indicated double screening. METHODS--Between June 1990 and December 1994, 117,890 negative smears were subjected to rapid re-screening. RESULTS--This study shows that rapid re-screening detects far greater numbers of false negative cases when compared with both 10% random re-screening and clinically indicated double screening, with no additional demand on human resources. The technique also identifies variation in the performance of screening personnel as an additional benefit. CONCLUSION--Rapid re-screening is an effective method of quality control. Although less sensitive, rapid re-screening should replace 10% random re-screening and selected re-screening as greater numbers of false negative results are detected while consuming less resources. PMID:8543619

Observational studies are complementary to randomized controlled trials.

PubMed

Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

2010-01-01

Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

A mathematical model of case-ascertainment bias: Applied to case-control studies nested within a randomized screening trial.

PubMed

Jansen, Rick J; Alexander, Bruce H; Hayes, Richard B; Miller, Anthony B; Wacholder, Sholom; Church, Timothy R

2018-01-01

When some individuals are screen-detected before the beginning of the study, but otherwise would have been diagnosed symptomatically during the study, this results in different case-ascertainment probabilities among screened and unscreened participants, referred to here as lead-time-biased case-ascertainment (LTBCA). In fact, this issue can arise even in risk-factor studies nested within a randomized screening trial; even though the screening intervention is randomly allocated to trial arms, there is no randomization to potential risk-factors and uptake of screening can differ by risk-factor strata. Under the assumptions that neither screening nor the risk factor affects underlying incidence and no other forms of bias operate, we simulate and compare the underlying cumulative incidence and that observed in the study due to LTBCA. The example used will be constructed from the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial. The derived mathematical model is applied to simulating two nested studies to evaluate the potential for screening bias in observational lung cancer studies. Because of differential screening under plausible assumptions about preclinical incidence and duration, the simulations presented here show that LTBCA due to chest x-ray screening can significantly increase the estimated risk of lung cancer due to smoking by 1% and 50%. Traditional adjustment methods cannot account for this bias, as the influence screening has on observational study estimates involves events outside of the study observation window (enrollment and follow-up) that change eligibility for potential participants, thus biasing case ascertainment.

Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

PubMed

Mhalu, Grace; Hella, Jerry; Doulla, Basra; Mhimbira, Francis; Mtutu, Hawa; Hiza, Helen; Sasamalo, Mohamed; Rutaihwa, Liliana; Rieder, Hans L; Seimon, Tamsyn; Mutayoba, Beatrice; Weiss, Mitchell G; Fenner, Lukas

2015-01-01

We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video. Randomized controlled trial. We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania). They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100) or standard of care (control group, n = 100). Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups. Median age was 39.1 years (interquartile range 37.0-50.0); 94 (47%) were females, 106 (53%) were males, and 49 (24.5%) were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p <0.0001), an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6-85.7%, versus 45%, 95% CI 35.0-55.3%, p <0.0001), and specimens less likely to be salivary (14%, 95% CI 7.9-22.4%, versus 39%, 95% CI 29.4-49.3%, p = 0.0001). Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%). Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%). Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum samples. If confirmed in larger studies, instructional videos may have a substantial effect on the case yield using sputum microscopy and also molecular tests. This low-cost strategy should be considered as part of the efforts to control TB in resource-limited settings. Pan African Clinical Trials Registry PACTR201504001098231.

Randomized Controlled Trial of Sertraline, Prolonged Exposure Therapy and Their Combination in OEF/OIF with PTSD

DTIC Science & Technology

2015-12-01

et al., Association of posttraumatic stress disorder with somatic symptoms, health care visits, and absenteeism among Iraq War veterans. The...American Journal of Psychiatry, 2007. 164(1): p. 150-153. 8. Marciniak, M., et al. Medical and productivity costs of anxiety disorders: Case control study

Risk factors for operated carpal tunnel syndrome: a multicenter population-based case-control study

PubMed Central

Mattioli, Stefano; Baldasseroni, Alberto; Bovenzi, Massimo; Curti, Stefania; Cooke, Robin MT; Campo, Giuseppe; Barbieri, Pietro G; Ghersi, Rinaldo; Broccoli, Marco; Cancellieri, Maria Pia; Colao, Anna Maria; dell'Omo, Marco; Fateh-Moghadam, Pirous; Franceschini, Flavia; Fucksia, Serenella; Galli, Paolo; Gobba, Fabriziomaria; Lucchini, Roberto; Mandes, Anna; Marras, Teresa; Sgarrella, Carla; Borghesi, Stefano; Fierro, Mauro; Zanardi, Francesca; Mancini, Gianpiero; Violante, Francesco S

2009-01-01

Background Carpal tunnel syndrome (CTS) is a socially and economically relevant disease caused by compression or entrapment of the median nerve within the carpal tunnel. This population-based case-control study aims to investigate occupational/non-occupational risk factors for surgically treated CTS. Methods Cases (n = 220) aged 18-65 years were randomly drawn from 13 administrative databases of citizens who were surgically treated with carpal tunnel release during 2001. Controls (n = 356) were randomly sampled from National Health Service registry records and were frequency matched by age-gender-specific CTS hospitalization rates. Results At multivariate analysis, risk factors were blue-collar/housewife status, BMI ≥ 30 kg/m2, sibling history of CTS and coexistence of trigger finger. Being relatively tall (cut-offs based on tertiles: women ≥165 cm; men ≥175 cm) was associated with lower risk. Blue-collar work was a moderate/strong risk factor in both sexes. Raised risks were apparent for combinations of biomechanical risk factors that included frequent repetitivity and sustained force. Conclusion This study strongly underlines the relevance of biomechanical exposures in both non-industrial and industrial work as risk factors for surgically treated CTS. PMID:19758429

Implementing Group Medical Visits for Older Adults at Group Health Cooperative

PubMed Central

Levine, Martin D.; Ross, Tyler R.; Balderson, Benjamin H.K.; Phelan, Elizabeth A.

2010-01-01

In a pair of randomized controlled trials in Kaiser Colorado in the 1990s, Group Visits for older adults (monthly non disease-specific group medical appointments for a cohort of patients led by primary care teams) were proven to reduce costs, decrease hospitalizations, and improve patient and provider satisfaction. As part of a translational effort, this Group Visit intervention was replicated in a delivery system in Seattle, WA, and the log of total health care costs measured in the first year of the intervention. Utilization and patient and physician satisfaction were secondary outcomes. For the cost and utilization analysis, a retrospective case-control design compared 221 case patients 65 years of age and older with high outpatient utilization in the previous 18 months with 1,015 control patient selected randomly from clinics not participating in the intervention. Controls were matched to cases on the number of primary care visits in the prior 18 months. Total costs were not statistically different for intervention patients compared to controls ($8,845 vs. $10,288, p=0.11), nor were there statistically significant differences in utilization, including hospital admissions and outpatient visits. However, patient and provider satisfaction was high. This translational effort did not demonstrate the cost savings of the original efficacy trials. Possible explanations for these divergent results may have to do with differences in those who participated and differences between the two delivery systems. PMID:20002506

No impact of dietary iodine restriction in short term development of hypothyroidism following fixed dose radioactive iodine therapy for Graves' disease.

PubMed

Jacob, Jubbin Jagan; Stephen, Charles; Paul, Thomas V; Thomas, Nihal; Oommen, Regi; Seshadri, Mandalam S

2015-01-01

The increased incidence of autoimmune thyroid disease with increasing dietary iodine intake has been demonstrated both epidemiologically and experimentally. The hypothyroidism that occurs in the first year following radioactive iodine therapy is probably related to the destructive effects of the radiation and underlying ongoing autoimmunity. To study the outcomes at the end of six months after fixed dose I, (131)therapy for Graves' disease followed by an iodine restricted diet for a period of six months. Consecutive adult patients with Graves' disease planned for I(131) therapy were randomized either to receive instructions regarding dietary iodine restriction or no advice prior to fixed dose (5mCi) I(131) administration. Thyroid functions and urinary iodine indices were evaluated at 3(rd) and 6(th) month subsequently. Forty seven patients (13M and 34F) were assessed, 2 were excluded, 45 were randomized (Cases 24 and Controls 21) and 39 patients completed the study. Baseline data was comparable. Median urinary iodine concentration was 115 and 273 μg/gm creat (p = 0.00) among cases and controls respectively. Outcomes at the 3(rd) month were as follows (cases and controls); Euthyroid (10 and 6: P = 0.24), Hypothyroid (3 and 5: P = 0.38) and Hyperthyroid (7 and 8: P = 0.64). Outcomes at the end of six months were as follows (cases and controls); Euthyroid (10 and 5: P = 0.12), Hypothyroid (3 and 5: P = 0.38) and Hyperthyroid (7 and 9: P = 0.43). Of the hypothyroid patients 5 (cases 1 and controls 4: P = 0.13) required thyroxine replacement. There was no statistical significant difference in the outcome of patients with dietary iodine restriction following I(131) therapy for Graves' disease.

The addition of a regional block team to the orthopedic operating rooms does not improve anesthesia-controlled times and turnover time in the setting of long turnover times.

PubMed

Eappen, Sunil; Flanagan, Hugh; Lithman, Rachel; Bhattacharyya, Neil

2007-03-01

To determine whether a regional block team with a dedicated space for performance of regional anesthetics would decrease turnover time and shorten the working day in a busy orthopedic practice with lengthy turnover times. Prospective, randomized study. Tertiary-care teaching hospital. 927 orthopedic procedures over a three-month period. The randomized placement of a regional block team to the orthopedic operating room (OR) suite. We evaluated the differences in anesthesia-controlled times, first-case start times, turnover times, and OR end times using a computerized OR information system. We also surveyed the surgeons regarding their perceptions of changes in turnover time and anesthesia-controlled times during the study period. Standard descriptive statistics were computed. Of a total of 927 cases, 398 cases were cared for by a regional block team and 529 cases received care in the usual manner, with the OR team providing the regional block. There was no difference between the study and control groups for on-time, first-case starts (57.73% vs 42.27%), induction time (13.2 vs 14.2 min), emergence time (8.1 vs 9.0 min), turnover time (70.3 vs 77.8 min), and OR end times. Most of the surgeons surveyed felt that the regional block team reduced turnover time significantly. A regional block team in this environment does not reduce anesthesia-controlled times and turnover times in an orthopedic OR suite with long turnover times, and it would be virtually impossible to recover the associated extra cost. The surgeons' perspective of turnover time is inaccurate.

75 FR 39220 - National Institute on Disability and Rehabilitation Research (NIDRR)-Disability and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

... free to choose experimental, quasi-experimental, case-control, or other applicable research designs...: Nothing in the priority either precludes or requires the use of randomized experimental trials of VR...

Cannabis use and cancer of the head and neck: case-control study.

PubMed

Aldington, Sarah; Harwood, Matire; Cox, Brian; Weatherall, Mark; Beckert, Lutz; Hansell, Anna; Pritchard, Alison; Robinson, Geoffrey; Beasley, Richard

2008-03-01

To investigate whether cannabis smoking increases the risk of head and neck cancer. Case-control study. Cases of head and neck cancer < or =55 years identified from hospital databases and the Cancer Registry, and controls randomly selected from the electoral roll completed interviewer-administered questionnaires. Logistic regression was used to estimate the relative risk of head and neck cancer. There were 75 cases and 319 controls. An increased risk of cancer was found with increasing tobacco use, alcohol consumption, and decreased income but not increasing cannabis use. The highest tertile of cannabis use (>8.3 joint years) was associated with a nonsignificant increased risk of cancer (relative risk = 1.6, 95% confidence interval, 0.5-5.2) after adjustment for confounding variables. Cannabis use did not increase the risk of head and neck cancer; however, because of the limited power and duration of use studied, a small or longer-term effect cannot be excluded.

Extracorporeal shock wave therapy of gastroc-soleus trigger points in patients with plantar fasciitis: A randomized, placebo-controlled trial.

PubMed

Moghtaderi, Alireza; Khosrawi, Saeid; Dehghan, Farnaz

2014-01-01

Plantar fasciitis is the most common cause of heel pain. Extracorporeal shock wave therapy (ESWT) is an alternative treatment for refractory cases of plantar fasciitis. Studies also demonstrated that ESWT may be an appropriate treatment for myofascial trigger points. This study was designed to evaluate its effectiveness by comparing the ESWT of Gastrocnemius/Soleus (gastroc-soleus) trigger points and heel region with the ESWT of the heel region alone. The study was carried out among 40 patients with a clinical diagnosis of plantar fasciitis, divided randomly to case (n = 20) and control (n = 20) groups. The case group received ESWT for the heel region and for the gastroc-soleus trigger points. The control group received ESWT just for the heel region. The protocol was the same in both groups and they were treated for three sessions every week. The pain score (100 mm visual analog score [VAS]) and the modified Roles and Maudsley score was evaluated before the first session and eight weeks after the last session. Eight weeks after the last session, although the mean VAS had decreased significantly in both groups, this decrement was more significant in the case group. (P = 0.04). According to the modified Roles and Maudsley score, there was a significant improvement in both the case (P < 0.001) and control (P = 0.01) groups, eight weeks after treatment, but there were significantly better results in the case group. The combination of ESWT for both plantar fasciitis and gastroc-soleus trigger points in treating patients with plantar fasciitis is more effective than utilizing it solely for plantar fasciitis.

Effectiveness of cefoxitin on preventing endometritis after uterine curettage for spontaneous incomplete abortion: a randomized controlled trial study.

PubMed

Titapant, Vitaya; Cherdchoogieat, Panida

2012-11-01

There are only few studies concerning the usage of antibiotics in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion and no conclusion can be demonstrated To investigate the effectiveness of prophylactic cefoxitin in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion. Eighty-four women with spontaneous first trimester incomplete abortion were randomly allocated into two groups using a computer-generated random number list and the allocation concealment was maintained using a sealed opaque envelope. The patients in the study group were given 1 g of cefoxitin while the patients in the control group were given 0.1 ml of vitamin B complex intravenously 20 minutes prior to curettage. Uterine curettage was performed after intravenous sedation and analgesic drugs were administered. The patients were evaluated on the first, third and seventh day after uterine curettage. Seventy-nine cases had completed the study protocol. There were no statistically significant differences in demographic data and details of uterine curettage between both groups. Two cases of endometritis were found in the control group but none in the study group. However the difference did not reach the statistical significance (p = 0.241). Prophylactic cefoxitin is not effective in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion.

Remote-online case-based learning: A comparison of remote-online and face-to-face, case-based learning - a randomized controlled trial.

PubMed

Nicklen, Peter; Keating, Jenny L; Paynter, Sophie; Storr, Michael; Maloney, Stephen

2016-01-01

Case-based learning (CBL) is an educational approach where students work in small, collaborative groups to solve problems. Computer assisted learning (CAL) is the implementation of computer technology in education. The purpose of this study was to compare the effects of a remote-online CBL (RO-CBL) with traditional face-to-face CBL on learning the outcomes of undergraduate physiotherapy students. Participants were randomized to either the control (face-to-face CBL) or to the CAL intervention (RO-CBL). The entire 3rd year physiotherapy cohort (n = 41) at Monash University, Victoria, Australia, were invited to participate in the randomized controlled trial. Outcomes included a postintervention multiple-choice test evaluating the knowledge gained from the CBL, a self-assessment of learning based on examinable learning objectives and student satisfaction with the CBL. In addition, a focus group was conducted investigating perceptions and responses to the online format. Thirty-eight students (control n = 19, intervention n = 19) participated in two CBL sessions and completed the outcome assessments. CBL median scores for the postintervention multiple-choice test were comparable (Wilcoxon rank sum P = 0.61) (median/10 [range] intervention group: 9 [8-10] control group: 10 [7-10]). Of the 15 examinable learning objectives, eight were significantly in favor of the control group, suggesting a greater perceived depth of learning. Eighty-four percent of students (16/19) disagreed with the statement "I enjoyed the method of CBL delivery." Key themes identified from the focus group included risks associated with the implementation of, challenges of communicating in, and flexibility offered, by web-based programs. RO-CBL appears to provide students with a comparable learning experience to traditional CBL. Procedural and infrastructure factors need to be addressed in future studies to counter student dissatisfaction and decreased perceived depth of learning.

Less deep vein thrombosis due to transcutaneous fibular nerve stimulation in total knee arthroplasty: a randomized controlled trial.

PubMed

Izumi, Masashi; Ikeuchi, Masahiko; Aso, Koji; Sugimura, Natsuki; Kamimoto, Yuko; Mitani, Tetsuya; Ueta, Tadashi; Sato, Takayuki; Yokoyama, Masataka; Sugiura, Tetsuro; Tani, Toshikazu

2015-11-01

It has been known for years that deep vein thrombi (DVT) start to develop during total joint arthroplasty. Previously, we reported effective prevention of venous stasis by transcutaneous electrical nerve stimulation (TENS). It is hypothesized that TENS might be a thromboprophylactic tool for the limb undergoing surgery. The purpose of this study is to clarify the clinical efficacy and safety of TENS in patients during total knee arthroplasty (TKA). Ninety patients undergoing primary TKA were involved and randomly allocated to the TENS or control group. In the TENS group, electrical stimulation of the common fibular nerve, which produced a brisk dorsiflexion of the ankle, was performed for the operated leg during surgery. In the control group, no electrical stimulation was applied. Serum D-dimer and soluble fibrin monomer complex (SFMC) levels were measured before surgery, immediately after surgery, and post-operative day (POD) 1. Ultrasonography was performed on POD 1. Immediately after surgery, D-dimer and SFMC levels of each group were significantly lower in the TENS group compared with control (p < 0.05). The incidence of DVT was 11 % (five cases) in the TENS group while 31 % (14 cases) in control (p = 0.02). There were no adverse effects related to TENS. TENS during TKA showed significant effects on preventing DVT. Sustaining muscle pump activation during surgery prevented not only venous stasis, but also hypercoagulability of blood. Intraoperative TENS is a safe and novel strategy against early post-operative thromboembolism, which is difficult to be completed through existing prophylaxis after total joint arthroplasty. Randomized controlled trial, Level I.

[Drinking-water type fluorosis treated with acupuncture of reinforcing kidney and activating spleen: a randomized controlled trial].

PubMed

Zhao, Xiao-guang; Wu, Zhong-chao; Chen, Zhong-jie; Wang, Jing-jing; Zhou, Jin-cao; Pang, Li; Jiao, Yue; Hu, Jing; Cui, Cheng-bin

2012-06-01

To observe the impacts of acupuncture of reinforcing kidney and activating spleen on the excretion of urinary fluoride and pain of the patients with drinking-water type fluorosis. The randomized controlled and single-blind trial was adopted. Seventy-two cases were randomized into an observation group and a control group, 36 cases in each one. In the observation group, acupuncture was applied at Pishu (BL 20), Shenshu (BL 23), Guanyuan (CV 4), Zusanli (ST 36), etc. , three treatments a week. In the control group, the Calcium Carbonate D3 tablets were prescribed for oral administration, 600 mg each time, twice a day. The duration of treatment was 2 months. The changes of the content of urinary fluoride and pain score (by VAS) before and after treatment between two groups were compared. The urinary fluoride excretion was increased obviously after treatment in the observation group (P < 0.01), which was superior apparently to that in the control group [(11.06 +/- 4.54) mg/L vs. (8.30 +/- 4.14) mg/L, P < 0.05]. After treatment, VAS score was reduced significantly in either group (both P < 0.01). The result in the observation group was lower remarkably than that in the control group (1.93 +/- 1.30 vs. 3.47 +/- 2.29, P < 0.01). Acupuncture achieves the significant efficacy on the promotion of urinary fluoride excretion and pain relieving of the patients with drinking-water type fluorosis in light of reinforcing kidney and activating spleen, which is superior to the oral administration of the calcium carbonate D3 tablets.

[Use of aripiprazole in the treatment of catatonia].

PubMed

Vörös, Viktor; Tényi, Tamás

2010-06-01

Successful aripiprazole treatment of catatonia was reported in some recent case reports. Review of the literature and three case reports. In the presented cases it was demonstrated that aripiprazole was effective in the treatment of catatonia in patients with schizophrenia, major depression or brief psychotic disorder. Besides benzodiazepines and electroconvulsive therapy, aripiprazole might be an alternative treatment for catatonia, however randomized controlled trials are required to prove the effectiveness of aripiprazole in patients with catatonia.

Haemorrhoids are associated with erectile dysfunction: a population-based study.

PubMed

Keller, J J; Lin, H-C

2012-12-01

Haemorrhoids are associated with regional vascular abnormalities and rectal pain, which are hypothesized to increase the risk of erectile dysfunction (ED); however, few studies have investigated the association between ED and haemorrhoids. This case-control study aimed to estimate the association between haemorrhoids and ED by using a population-based data in Taiwan. We identified 6,310 patients with ED as cases and randomly selected 31,550 controls. Conditional logistic regression was performed to compute the odds ratio (OR) for having been previously diagnosed with haemorrhoids between cases and controls. The results show that haemorrhoids were found to be present among 1,572 (24.9%) cases and 4,491 (14.20%) controls. The OR for prior haemorrhoids among cases was 1.90 (95% CI = 1.78-2.03) when compared with controls after adjusting for monthly income, geographical location, hypertension, diabetes, coronary heart disease, hyperlipidemia, obesity and alcohol abuse/alcohol dependence syndrome. Younger cases demonstrated a higher risk for prior haemorrhoids when compared with controls. In particular, the adjusted OR among cases <30 years old was 3.71 (95% CI = 2.74-5.02) when compared with controls. We concluded that there was an association between ED and a prior diagnosis of haemorrhoids. © 2012 The Authors. International Journal of Andrology © 2012 European Academy of Andrology.

[False positive result in mammography and its association with the presence of obesity: a case-control study].

PubMed

Castro-Ibarra, Marisela; Menchaca-Díaz, Rufino; Cabrales-Ruvalcaba, J Jesús; Luna-V Gómez, Rosa Alicia

2016-01-01

To analyze the association between a false positive result in mammography and obesity, inside the breast cancer early detection program in women affiliated to the Institute of Security and Social Services for Government and Municipality workers of the State of Baja California (ISSSTECALI). A case-control, retrospective study was done in women affiliated to ISSSTECALI to whom a mammography was performed between 2009 and 2012. Women with a false positive result in mammography were included as cases. Controls were women with a true negative result in mammography. Three controls were randomly selected for each case. Obesity was established with the body mass index (BMI) consigned in the woman's clinical file. Age and estrogen replacement therapy were included as co-variables. Seventy nine cases were identified and 237 controls were included. Obesity was observed in 54.4% of cases and in 41.3% of controls (odds ratio: 1.69; 95% confidence interval for odds ratio: 1.01-2.82; p value: 0.043). A logistic regression model including covariables maintained the observed association (p = 0.044). No association was found with analyzed co-variables. A false positive result in mammography was associated with the presence of obesity.

Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.

PubMed

Zhang, J; Chen, X; Zhu, Q; Cui, J; Cao, L; Su, J

2016-11-01

In recent years, the number of randomized controlled trials (RCTs) in the field of orthopaedics is increasing in Mainland China. However, randomized controlled trials (RCTs) are inclined to bias if they lack methodological quality. Therefore, we performed a survey of RCT to assess: (1) What about the quality of RCTs in the field of orthopedics in Mainland China? (2) Whether there is difference between the core journals of the Chinese department of orthopedics and Orthopaedics Traumatology Surgery & Research (OTSR). This research aimed to evaluate the methodological reporting quality according to the CONSORT statement of randomized controlled trials (RCTs) in seven key orthopaedic journals published in Mainland China over 5 years from 2010 to 2014. All of the articles were hand researched on Chongqing VIP database between 2010 and 2014. Studies were considered eligible if the words "random", "randomly", "randomization", "randomized" were employed to describe the allocation way. Trials including animals, cadavers, trials published as abstracts and case report, trials dealing with subgroups analysis, or trials without the outcomes were excluded. In addition, eight articles selected from Orthopaedics Traumatology Surgery & Research (OTSR) between 2010 and 2014 were included in this study for comparison. The identified RCTs are analyzed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT), including the sample size calculation, allocation sequence generation, allocation concealment, blinding and handling of dropouts. A total of 222 RCTs were identified in seven core orthopaedic journals. No trials reported adequate sample size calculation, 74 (33.4%) reported adequate allocation generation, 8 (3.7%) trials reported adequate allocation concealment, 18 (8.1%) trials reported adequate blinding and 16 (7.2%) trials reported handling of dropouts. In OTSR, 1 (12.5%) trial reported adequate sample size calculation, 4 (50.0%) reported adequate allocation generation, 1 (12.5%) trials reported adequate allocation concealment, 2 (25.0%) trials reported adequate blinding and 5 (62.5%) trials reported handling of dropouts. There were statistical differences as for sample size calculation and handling of dropouts between papers from Mainland China and OTSR (P<0.05). The findings of this study show that the methodological reporting quality of RCTs in seven core orthopaedic journals from the Mainland China is far from satisfaction and it needs to further improve to keep up with the standards of the CONSORT statement. Level III case control. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Methylphenidate as a treatment for stuttering: a case report.

PubMed

Devroey, D; Beerens, G; Van De Vijver, E

2012-10-01

A randomized placebo controlled trial with methylphenidate (MPH) was set up to identify the effects of MPH on cognition in healthy young adults (ea. without attention deficit hyperactivity disorder, ADHD). Subjects repeatedly performed tests of the immediate and delayed memory and vigilance tasks after administration of placebo or 20 mg MPH. We report the case of an 18 year old man who participated in the study. He suffered from stuttering since childhood. During the study phase he reported a remarkable relief of the stuttering after the intake of 20 mg MPH. For D-amphetamine the beneficial effect on stuttering has been demonstrated but it was never implemented in clinical practice because of important adverse events. MPH, an amphetamine analogue, doesn't present these side effects. For this reason, MPH seems to merit further investigation in a randomized-controlled trial as a possible agent in the treatment of stuttering.Methylphenidate, Stuttering.

Hybrid time-variant reliability estimation for active control structures under aleatory and epistemic uncertainties

NASA Astrophysics Data System (ADS)

Wang, Lei; Xiong, Chuang; Wang, Xiaojun; Li, Yunlong; Xu, Menghui

2018-04-01

Considering that multi-source uncertainties from inherent nature as well as the external environment are unavoidable and severely affect the controller performance, the dynamic safety assessment with high confidence is of great significance for scientists and engineers. In view of this, the uncertainty quantification analysis and time-variant reliability estimation corresponding to the closed-loop control problems are conducted in this study under a mixture of random, interval, and convex uncertainties. By combining the state-space transformation and the natural set expansion, the boundary laws of controlled response histories are first confirmed with specific implementation of random items. For nonlinear cases, the collocation set methodology and fourth Rounge-Kutta algorithm are introduced as well. Enlightened by the first-passage model in random process theory as well as by the static probabilistic reliability ideas, a new definition of the hybrid time-variant reliability measurement is provided for the vibration control systems and the related solution details are further expounded. Two engineering examples are eventually presented to demonstrate the validity and applicability of the methodology developed.

Orthodontic treatment in periodontitis‐susceptible subjects: a systematic literature review

PubMed Central

Lindsten, Rune; Slotte, Christer; Bjerklin, Krister

2016-01-01

Abstract The aim is to evaluate the literature for clinical scientific data on possible effects of orthodontic treatment on periodontal status in periodontitis‐susceptible subjects. A systematic literature review was performed on studies in English using PubMed, MEDLINE, and Cochrane Library central databases (1965‐2014). By manually searching reference lists of selected studies, we identified additional articles; then we searched these publications: Journal of Periodontology, Periodontology 2000, Journal of Clinical Periodontology, American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, International Journal of Periodontics & Restorative Dentistry, and European Journal of Orthodontics. Search terms included randomized clinical trials, controlled clinical trials, prospective and retrospective clinical studies, case series >5 patients, periodontitis, orthodontics, alveolar bone loss, tooth migration, tooth movement, orthodontic extrusion, and orthodontic intrusion. Only studies on orthodontic treatment in periodontally compromised dentitions were included. One randomized controlled clinical trial, one controlled clinical trial, and 12 clinical studies were included. No evidence currently exists from controlled studies and randomized controlled clinical trials, which shows that orthodontic treatment improves or aggravates the status of periodontally compromised dentitions. PMID:29744163

Cognitive enhancement treatments for bipolar disorder: A systematic review and methodological recommendations.

PubMed

Miskowiak, Kamilla W; Carvalho, André F; Vieta, Eduard; Kessing, Lars V

2016-10-01

Cognitive dysfunction is an emerging treatment target in bipolar disorder (BD). Several trials have assessed the efficacy of novel pharmacological and psychological treatments on cognition in BD but the findings are contradictory and unclear. A systematic search following the PRISMA guidelines was conducted on PubMed and PsychInfo. Eligible articles reported randomized, controlled or open-label trials investigating pharmacological or psychological treatments targeting cognitive dysfunction in BD. The quality of the identified randomized controlled trials (RCTs) was evaluated with the Cochrane Collaboration's Risk of Bias tool. We identified 19 eligible studies of which 13 were RCTs and six were open-label or non-randomized studies. The findings regarding efficacy on cognition were overall disappointing or preliminary, possibly due to several methodological challenges. For the RCTs, the risk of bias was high in nine cases, unclear in one case and low in three cases. Key reasons for the high risk of bias were lack of details on the randomization process, suboptimal handling of missing data and lack of a priori priority between cognition outcomes. Other challenges were the lack of consensus on whether and how to screen for cognitive impairment and on how to assess efficacy on cognition. In conclusion, methodological problems are likely to impede the success rates of cognition trials in BD. We recommend adherence to the CONSORT guidelines for RCTs, screening for cognitive impairment before inclusion of trial participants and selection of one primary cognition outcome. Future implementation of a 'neurocircuitry-based' biomarker model to evaluate neural target engagement is warranted. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

Effects of a 3-year nurse-based case management in aged patients with acute myocardial infarction on rehospitalisation, mortality, risk factors, physical functioning and mental health. a secondary analysis of the randomized controlled KORINNA study.

PubMed

Kirchberger, Inge; Hunger, Matthias; Stollenwerk, Björn; Seidl, Hildegard; Burkhardt, Katrin; Kuch, Bernhard; Meisinger, Christa; Holle, Rolf

2015-01-01

Home-based secondary prevention programs led by nurses have been proposed to facilitate patients' adjustment to acute myocardial infarction (AMI). The objective of this study was to conduct secondary analyses of the three-year follow-up of a nurse-based case management for elderly patients discharged from hospital after an AMI. In a single-centre randomized two-armed parallel group trial of hospitalized patients with AMI ≥65 years, patients hospitalized between September 2008 and May 2010 in the Hospital of Augsburg, Germany, were randomly assigned to case management or usual care. The case-management intervention consisted of a nurse-based follow-up for three years including home visits and telephone calls. Study endpoints were time to first unplanned readmission or death, clinical parameters, functional status, depressive symptoms and malnutrition risk. Persons who assessed three-year outcomes and validated readmission data were blinded. The intention-to-treat approach was applied to the statistical analyses which included Cox Proportional Hazards models. Three hundred forty patients were allocated to receive case-management (n = 168) or usual care (n = 172). During three years, in the intervention group there were 80 first unplanned readmissions and 6 deaths, while the control group had 111first unplanned readmissions and 3 deaths. The intervention did not significantly affect time to first unplanned readmission or death (Hazard Ratio 0.89, 95% confidence interval (CI) 0.67-1.19; p = 0.439), blood pressure, cholesterol level, instrumental activities of daily life (IADL) (only for men), and depressive symptoms. However, patients in the intervention group had a significantly better functional status, as assessed by the HAQ Disability Index, IADL (only for women), and hand grip strength, and better SCREEN-II malnutrition risk scores than patients in the control group. A nurse-based management among elderly patients with AMI did not significantly affect time to unplanned readmissions or death during a three-year follow-up. However, the results indicate that functional status and malnutrition risk can be improved. Current Controlled Trials ISRCTN02893746.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

Testing self-regulation interventions to increase walking using factorial randomized N-of-1 trials.

PubMed

Sniehotta, Falko F; Presseau, Justin; Hobbs, Nicola; Araújo-Soares, Vera

2012-11-01

To investigate the suitability of N-of-1 randomized controlled trials (RCTs) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory (goal setting and self-monitoring) for promoting walking in healthy adult volunteers. A series of N-of-1 RCTs in 10 normal and overweight adults ages 19-67 (M = 36.9 years). We randomly allocated 60 days within each individual to text message-prompted daily goal-setting and/or self-monitoring interventions in accordance with a 2 (step-count goal prompt vs. alternative goal prompt) × 2 (self-monitoring: open vs. blinded Omron-HJ-113-E pedometer) factorial design. Aggregated data were analyzed using random intercept multilevel models. Single cases were analyzed individually. The primary outcome was daily pedometer step counts over 60 days. Single-case analyses showed that 4 participants significantly increased walking: 2 on self-monitoring days and 2 on goal-setting days, compared with control days. Six participants did not benefit from the interventions. In aggregated analyses, mean step counts were higher on goal-setting days (8,499.9 vs. 7,956.3) and on self-monitoring days (8,630.3 vs. 7,825.9). Multilevel analyses showed a significant effect of the self-monitoring condition (p = .01), the goal-setting condition approached significance (p = .08), and there was a small linear increase in walking over time (p = .03). N-of-1 randomized trials are a suitable means to test behavioral interventions in individual participants.

When Wait Lists Are Not Feasible, Nothing Is a Thing That Does Not Need to Be Done

ERIC Educational Resources Information Center

Devilly, Grant J.; McFarlane, Alexander C.

2009-01-01

Clinical psychology practices initially grew through the use of case studies, uncontrolled trials, and eventually through randomized controlled trials (RCTs). The use of a wait-list control group is standard practice in such trials of treatment regimens for psychopathological conditions. However, as knowledge advances regarding the successful…

Environmental Exposures, Genetic Polymorphisms and p53 Mutational Spectra in a Case-Control Study of Breast Cancer.

DTIC Science & Technology

1998-01-01

Further, preliminary clinical data suggest that serotonin reuptake inhibitors , such as fluoxetinc hydrochloride, may promote smoking cessation (15,16...benefits of serotonin reuptake inhibitors in smoking cessation (16) suggested that this gene may be a plausible candidate for predisposition to... used for random selection of women under age 65; women age 65 and over were randomly selected from the listing of the Health Care Finance

The effects of combining Web-based eHealth with telephone nurse case management for pediatric asthma control: a randomized controlled trial.

PubMed

Gustafson, David; Wise, Meg; Bhattacharya, Abhik; Pulvermacher, Alice; Shanovich, Kathleen; Phillips, Brenda; Lehman, Erik; Chinchilli, Vernon; Hawkins, Robert; Kim, Jee-Seon

2012-07-26

Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. To test the effects of (1) CHESS+CM, a system for parents and children ages 4-12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. We identified eligible parent-child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. Of 305 parent-child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child's Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = -0.31, 95% confidence limits [CL] -0.56, -0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL -0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL -8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM's effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz).

The Use of Milrinone in Patients with Delayed Cerebral Ischemia Following Subarachnoid Hemorrhage: A Systematic Review.

PubMed

Lannes, Marcelo; Zeiler, Frederick; Guichon, Céline; Teitelbaum, Jeanne

2017-03-01

The purpose of this article is to provide a systematic review of the evidence supporting the use of milrinone for the management of delayed cerebral ischemia (DCI) following subarachnoid hemorrhage (SAH). Primary outcomes were functional neurological status and the incidence of cerebral infarction. Search strategies adapted to the different databases were developed by a professional librarian. Medline, EMBASE, the Cochrane Library database, Web of Science, SCOPUS, BIOSIS, Global Health, Health Star, Open SIGLE, Google Scholar and the New York Academy of Medicine Gray Literature were searched as well as clinical trials databases and the proceedings of several scientific meetings. Quality of the evidence for these outcomes across studies was adjudicated using the GRADE Working Group criteria. The search resulted in 284 citations after elimination of duplicates. Of those 9 conference proceedings and 15 studies met inclusion criteria and consisted of case reports, case series and two comparative studies: one non-randomized study with physiological outcomes only and a case series with historical controls. There was considerable variation in dosing and in co-interventions and no case control or randomized controlled studies were found. There is currently only very low quality evidence to support the use of milrinone to improve important outcomes in patients with delayed cerebral ischemia secondary to subarachnoid hemorrhage. Further research is needed to clarify the value and risks of this medication in patients with SAH.

Bias reduction in repeated-measures observational studies by the use of propensity score: the case of enteral sedation for critically ill patients.

PubMed

Umbrello, Michele; Mistraletti, Giovanni; Corbella, Davide; Cigada, Marco; Salini, Silvia; Morabito, Alberto; Iapichino, Gaetano

2012-12-01

Within the evidence-based medicine paradigm, randomized controlled trials represent the "gold standard" to produce reliable evidence. Indeed, planning and implementing randomized controlled trials in critical care medicine presents limitations because of intrinsic and structural problems. As a consequence, observational studies still occur frequently. In these cases, propensity score (PS) (probability of receiving a treatment conditional on observed covariates) is an increasingly used technique to adjust the results. Few studies addressed the specific issue of a PS correction of repeated-measures designs. Three techniques for correcting the analysis of nonrandomized designs (matching, stratification, regression adjustment) are presented in a tutorial form and applied to a real case study: the comparison between intravenous and enteral sedative therapy in the intensive care unit setting. After showing the results before and after the use of PS, we suggest that such a tool allows to partially overcoming the bias associated with the observational nature of the study. It permits to correct the estimates for any observed covariate, while unobserved confounders cannot be controlled for. Propensity score represents a useful additional tool to estimate the effects of treatments in nonrandomized studies. In the case study, an enteral sedation approach was equally effective to an intravenous regime, allowing for a lower level of sedation and spare of resources. Copyright © 2012 Elsevier Inc. All rights reserved.

Valid statistical inference methods for a case-control study with missing data.

PubMed

Tian, Guo-Liang; Zhang, Chi; Jiang, Xuejun

2018-04-01

The main objective of this paper is to derive the valid sampling distribution of the observed counts in a case-control study with missing data under the assumption of missing at random by employing the conditional sampling method and the mechanism augmentation method. The proposed sampling distribution, called the case-control sampling distribution, can be used to calculate the standard errors of the maximum likelihood estimates of parameters via the Fisher information matrix and to generate independent samples for constructing small-sample bootstrap confidence intervals. Theoretical comparisons of the new case-control sampling distribution with two existing sampling distributions exhibit a large difference. Simulations are conducted to investigate the influence of the three different sampling distributions on statistical inferences. One finding is that the conclusion by the Wald test for testing independency under the two existing sampling distributions could be completely different (even contradictory) from the Wald test for testing the equality of the success probabilities in control/case groups under the proposed distribution. A real cervical cancer data set is used to illustrate the proposed statistical methods.

Randomly Sampled-Data Control Systems. Ph.D. Thesis

NASA Technical Reports Server (NTRS)

Han, Kuoruey

1990-01-01

The purpose is to solve the Linear Quadratic Regulator (LQR) problem with random time sampling. Such a sampling scheme may arise from imperfect instrumentation as in the case of sampling jitter. It can also model the stochastic information exchange among decentralized controllers to name just a few. A practical suboptimal controller is proposed with the nice property of mean square stability. The proposed controller is suboptimal in the sense that the control structure is limited to be linear. Because of i. i. d. assumption, this does not seem unreasonable. Once the control structure is fixed, the stochastic discrete optimal control problem is transformed into an equivalent deterministic optimal control problem with dynamics described by the matrix difference equation. The N-horizon control problem is solved using the Lagrange's multiplier method. The infinite horizon control problem is formulated as a classical minimization problem. Assuming existence of solution to the minimization problem, the total system is shown to be mean square stable under certain observability conditions. Computer simulations are performed to illustrate these conditions.

Comparing U.S. Army suicide cases to a control sample: initial data and methodological lessons.

PubMed

Alexander, Cynthia L; Reger, Mark A; Smolenski, Derek J; Fullerton, Nicole R

2014-10-01

Identification of risk and protective factors for suicide is a priority for the United States military, especially in light of the recent steady increase in military suicide rates. The Department of Defense Suicide Event Report contains comprehensive data on suicides for active duty military personnel, but no analogous control data is available to permit identification of factors that differentially determine suicide risk. This proof-of-concept study was conducted to determine the feasibility of collecting such control data. The study employed a prospective case-control design in which control cases were randomly selected from a large Army installation at a rate of four control participants for every qualifying Army suicide. Although 111 Army suicides were confirmed during the study period, just 27 control soldiers completed the study. Despite the small control sample, preliminary analyses comparing suicide cases to controls identified several factors more frequently reported for suicide cases, including recent failed intimate relationships, outpatient mental health history, mood disorder diagnosis, substance abuse history, and prior self-injury. No deployment-related risk factors were found. These data are consistent with existing literature and form a foundation for larger control studies. Methodological lessons learned regarding study design and recruitment are discussed to inform future studies. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

Day care PNL using 'Santosh-PGI hemostatic seal' versus standard PNL: A randomized controlled study.

PubMed

Kumar, Santosh; Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

2016-01-01

To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p <0.05). The incidence of urine leakage through the access tract site was significantly lower in the DCS subgroup when compared to the controls (3.6% vs. 21.1%, p <0.05). Cases in the DCS group resumed their normal activities in a significantly shorter time (8.05 ±3.05 vs.18.42 ±4.42 days; p <0.05). Higher proportion of cases in the DCS group got re-admitted, although it was not a statistically significant number (7.1% vs. 1.8%; p = 0.21). Tubeless day care PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission.

Day care PNL using ‘Santosh-PGI hemostatic seal’ versus standard PNL: A randomized controlled study

PubMed Central

Singh, Shivanshu; Singh, Prashant; Singh, Shrawan Kumar

2016-01-01

Introduction To compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL. Material and methods It was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery. Results A total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p <0.05). The incidence of urine leakage through the access tract site was significantly lower in the DCS subgroup when compared to the controls (3.6% vs. 21.1%, p <0.05). Cases in the DCS group resumed their normal activities in a significantly shorter time (8.05 ±3.05 vs.18.42 ±4.42 days; p <0.05). Higher proportion of cases in the DCS group got re-admitted, although it was not a statistically significant number (7.1% vs. 1.8%; p = 0.21). Conclusions Tubeless day care PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission. PMID:27551557

Electroconvulsive therapy (ECT) for treating agitation in dementia (major neurocognitive disorder) - a promising option.

PubMed

Glass, Oliver M; Forester, Brent P; Hermida, Adriana P

2017-05-01

Agitation in patients with dementia increases caretaker burden, increases healthcare costs, and worsens the patient's quality of life. Antipsychotic medications, commonly used for the treatment of agitation in patients with dementia have a box warning from the FDA for elevated mortality risk. Electroconvulsive therapy (ECT) has made significant advances over the past several years, and is efficacious in treating a wide range of psychiatric conditions. We provide a systematic review of published literature regarding the efficacy of ECT for the treatment of agitation in patients with dementia (major neurocognitive disorder). We searched PubMed, Medline, Google Scholar, UptoDate, Embase, and Cochrane for literature concerning ECT for treating agitation in dementia using the title search terms "ECT agitation dementia;" "ECT aggression dementia;" "ECT Behavior and Psychological Symptoms of Dementia;" and "ECT BPSD." The term "dementia" was also interchanged with "Major Neurocognitive Disorder." No time frame restriction was placed. We attempted to include all publications that were found to ensure a comprehensive review. We found 11 papers, with a total (N) of 216 patients. Limited to case reports, case series, retrospective chart review, retrospective case-control, and an open label prospective study, ECT has demonstrated promising results in decreasing agitation in patients with dementia. Patients who relapsed were found to benefit from maintenance ECT. Available studies are often limited by concomitant psychotropic medications, inconsistent use of objective rating scales, short follow-up, lack of a control group, small sample sizes, and publication bias. A future randomized controlled trial will pose ethical and methodological challenges. A randomized controlled trial must carefully consider the definition of usual care as a comparison group. Well-documented prospective studies and/or additional case series with explicit selection criteria, a wide range of outcome measures, and less selection bias of the study sample that may favor treatment response, is warranted. ECT may be a promising option for the treatment of aggression and agitation in patients with severe dementia who are refractory to other treatment options, but the limitations of available studies suggest that a cautious approach to future randomized controlled trials is warranted.

Tuberculosis and diabetes mellitus in the Republic of Kiribati: a case-control study.

PubMed

Viney, K; Cavanaugh, J; Kienene, T; Harley, D; Kelly, P M; Sleigh, A; O'Connor, J; Mase, S

2015-05-01

To better inform local management of TB-diabetes collaborative activities, we aimed to determine the prevalence of diabetes among persons with and without TB and to determine the association between TB and diabetes in Kiribati, a Pacific Island nation. We compared consecutively enrolled TB cases to a group of randomly selected community controls without evidence of TB. Diabetes was diagnosed by HbA1c, and clinical and demographic data were collected. A tuberculin skin test was administered to controls. The chi-square test was used to assess significance in differences between cases and controls. We also calculated an odds ratio, with 95% confidence intervals, for the odds of diabetes among cases relative to controls. Unweighted multivariate logistic regression was performed to adjust for the effects of age and sex. A total of 275 TB cases and 499 controls were enrolled. The diabetes prevalence in cases (101, 37%) was significantly greater than in controls (94, 19%) (adjusted odds ratio: 2.8; 95% CI 2.0-4.1). Fifty-five percent (108) of all diabetic diagnoses were new; this proportion was higher among controls (64.8%) than cases (46.5%). Five patients with TB were screened to detect one patient with diabetes. There is a strong association between TB and diabetes in Kiribati and bidirectional screening should be conducted in this setting. © 2015 John Wiley & Sons Ltd.

[Acupotomy and acupuncture in the treatment of avascular necrosis of femoral head at the early and middle stages:a clinical randomized controlled trial].

PubMed

Wang, Zhanyou; Zhou, Xuelong; Xie, Lishuang; Liang, Dongyue; Wang, Ying; Zhang, Hong-An; Zheng, Jinghong

2016-10-12

To compare the efficacy difference between acupotomy and acupuncture in the treatment of avascular necrosis of femoral head at the early and middle stages. The randomized controlled prospective study method was adopted. Sixty cases of avascular necrosis of femoral head at Ficat-ArletⅠto Ⅱ stages were randomized into an acupotomy group (32 cases) and an acupuncture group (28 cases) by the third part. In the acupotomy group, the acupotomy was adopted for the loose solution at the treatment sites of hip joint, once every two weeks, totally for 3 times. In the acupuncture group, ashi points around the hip joint were selected and stimulated with warm acupuncture therapy, once every day, for 6 weeks. Harris hip score was observed before and after treatment. The efficacy was evaluated in the two groups. Harris hip score was improved significantly after treatment in the two groups (both P <0.05). The result in acupotomy group was better than that in the acupuncture group ( P <0.05). The effective rate was 90.6% (29/32) in the acupotomy group, better than 75.0% (21/28) in the acupuncture group after treatment ( P <0.05). Harris hip score and the effective rate in the acupotomy group are better than those in the treatment with routine acupuncture for avascular necrosis of femoral head at the early and middle stages.

Incomplete caries removal and indirect pulp capping in primary molars: a randomized controlled trial.

PubMed

Bressani, Ana Eliza Lemes; Mariath, Adriela Azevedo Souza; Haas, Alex Nogueira; Garcia-Godoy, Franklin; de Araujo, Fernando Borba

2013-08-01

To compare the effect of incomplete caries removal (ICR) and indirect pulp capping (IPC) with calcium hydroxide (CH) or an inert material (wax) on color, consistency and contamination of the remaining dentin of primary molars. This double-blind, parallel-design, randomized controlled trial included 30 children presenting one primary molar with deep caries lesion. Children were randomly assigned after ICR to receive IPC with CH or wax. All teeth were then restored with resin composite. Baseline dentin color and consistency were evaluated after ICR, and dentin samples were collected for contamination analyses using scanning electron microscopy. After 3 months, restorations were removed and the three parameters were re-evaluated. In both groups, dentin became significantly darker after 3 months. No cases of yellow dentin were observed after 3 months with CH compared to 33.3% of the wax cases (P < 0.05). A statistically significant difference over time was observed only for CH regarding consistency. CH stimulated a dentin hardening process in a statistically higher number of cases than wax (86.7% vs. 33.3%; P = 0.008). Contamination changed significantly over time in CH and wax without significant difference between groups. It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping, but CH showed superior dentin color and consistency after 3 months.

Remote just-in-time telementored trauma ultrasound: a double-factorial randomized controlled trial examining fluid detection and remote knobology control through an ultrasound graphic user interface display.

PubMed

Kirkpatrick, Andrew W; McKee, Ian; McKee, Jessica L; Ma, Irene; McBeth, Paul B; Roberts, Derek J; Wurster, Charles L; Parfitt, Robbie; Ball, Chad G; Oberg, Scott; Sevcik, William; Hamilton, Douglas R

2016-05-01

Remote-telementored ultrasound involves novice examiners being remotely guided by experts using informatic-technologies. However, requiring a novice to perform ultrasound is a cognitively demanding task exacerbated by unfamiliarity with ultrasound-machine controls. We incorporated a randomized evaluation of using remote control of the ultrasound functionality (knobology) within a study in which the images generated by distant naive examiners were viewed on an ultrasound graphic user interface (GUI) display viewed on laptop computers by mentors in different cities. Fire-fighters in Edmonton (101) were remotely mentored from Calgary (n = 65), Nanaimo (n = 19), and Memphis (n = 17) to examine an ultrasound phantom randomized to contain free fluid or not. Remote mentors (2 surgeons, 1 internist, and 1 ED physician) were randomly assigned to use GUI knobology control during mentoring (GUIK+/GUIK-). Remote-telementored ultrasound was feasible in all cases. Overall accuracy for fluid detection was 97% (confidence interval = 91 to 99%) with 3 false negatives (FNs). Positive/negative likelihood ratios were infinity/0.0625. One FN occurred with the GUIK+ and 2 without (GUIK-). There were no statistical test performance differences in either group (GUIK+ and GUIK-). Ultrasound-naive 1st responders can be remotely mentored with high accuracy, although providing basic remote control of the knobology did not affect outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Failing to Prepare Is Preparing to Fail: A Single-Blinded, Randomized Controlled Trial to Determine the Impact of a Preoperative Instructional Video on the Ability of Residents to Perform Laparoscopic Right Colectomy.

PubMed

Crawshaw, Benjamin P; Steele, Scott R; Lee, Edward C; Delaney, Conor P; Mustain, W Conan; Russ, Andrew J; Shanmugan, Skandan; Champagne, Bradley J

2016-01-01

Laparoscopic colorectal resection is an index case for advanced skills training, yet many residents struggle to reach proficiency by graduation. Current methods to reduce the learning curve for residents remain expensive, time consuming, and poorly validated. The purpose of this study was to assess the impact of the addition of a preprocedural instructional video to improve the ability of a general surgery resident to perform laparoscopic right colectomy when compared with standard preparation. This was a single-blinded, randomized control study. Four university-affiliated teaching hospitals were included in the study. General surgery residents in postgraduation years 2 through 5 participated. Residents were randomly assigned to preparation with a narrated instructional video versus standard preparation. Resident performance, scored by a previously validated global assessment scale, was measured. Fifty-four residents were included. Half (n = 27) were randomly assigned to view the training video and half (n = 27) to standard preparation. There were no differences between groups in terms of training level or previous operative experience or in patient demographics (all p > 0.05). Groups were similar in the percentage of the case completed by residents (p = 0.39) and operative time (p = 0.74). Residents in the video group scored significantly higher in total score (mean: 46.8 vs 42.3; p = 0.002), as well as subsections directly measuring laparoscopic skill (vascular control mean: 11.3 vs 9.7, p < 0.001; mobilization mean: 7.6 vs. 7.0, p = 0.03) and overall performance score (mean: 4.0 vs 3.1; p < 0.001). Statistical significance persisted across training levels. There is potential for Hawthorne effect, and the study is underpowered at the individual postgraduate year level. The simple addition of a brief, narrated preprocedural video to general surgery resident case preparation significantly increased trainee ability to successfully perform a laparoscopic right colectomy. In an era of shortened hours and less exposure to cases, incorporating a brief but effective instructional video before surgery may improve the learning curve of trainees and ultimately improve safety.

[Multi-central controlled study on three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen].

PubMed

Zhou, Yun-feng; Wei, Yu-long; Zhang, Pu-lin; Gao, Shan; Ning, Guo-li; Zhang, Zhen-qiang; Hu, Bin; Wang, Dan-yi; Yan, Mei-rong; Liu, Wen-jun

2006-06-01

To make multi-central clinical evaluation for three-part massage therapy for treatment of insomnia of deficiency of both the heart and spleen. One hundred and sixty-six cases were randomly divided into a test group (n = 84) and a control group (n = 82). Multi-central, randomized and controlled methods were adopted. The test group were treated by the three-part massage therapy, i. e. acupoints at the head, abdomen and back were massaged, once each day; and the control group by oral administration of Guipi Pills [symbol: see text], 8 pills each time, thrice daily. The treatment was given for 15 consecutive days and then the therapeutic effects were observed. Sixty-seven cases were cured, 11 markedly effective, 3 effective, and 3 ineffective in the test group, and the corresponding figures were 10, 21, 29 and 22 in the control group with a very significant difference between the two groups (P< 0.001). The test group was superior to the control group in improvement for Pittsburgh Sleep Quality Index (PSQI), Sleepless Anxiety Scale (SAS) and Sleepless Depression Scale (SDS) (P < 0.001). The three-part massage therapy has definite therapeutic effect on insomnia of deficiency of both the heart and spleen with safety.

[Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

PubMed

Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

2010-10-01

to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

Randomized control trial: Online parent program and waiting period for unmarried parents in Title IV-D court.

PubMed

Rudd, Brittany N; Holtzworth-Munroe, Amy; Reyome, Jason G; Applegate, Amy G; D'Onofrio, Brian M

2015-10-01

Despite a lack of research on parent education programs for unmarried parents, many judicial officers mandate participation. We recruited an understudied sample likely at high risk for negative outcomes-182 court cases involving unmarried parents on government assistance in which paternity was contested and then established via genetic testing ordered by the court. This 2 × 2 randomized controlled trial evaluated the impact on initial litigation outcomes of two factors: (a) participation in an online parent education program or not and (b) having a waiting period between the establishment of paternity and the court hearing concerning child-related issues or not. Using an intent-to-treat framework, we found that among cases not assigned to the program, there was no difference in the rate of full agreement on child-related issues (e.g., child support, custody, parenting time) when comparing cases assigned to a waiting period and cases not assigned to a waiting period. In contrast, for cases assigned to the program, cases also assigned a waiting period were less likely to reach a full agreement than cases that had their hearing on the same day. In addition, cases in the "program and waiting period" condition were less likely to return to court for their hearing than cases in the "no program and waiting period" condition. In exploratory analyses of the subsample of cases in which both parents were present at the court hearing, the pattern of results remained the same, although the findings were no longer statistically significant. (c) 2015 APA, all rights reserved).

Effectiveness of Case-Based Learning Instruction on Epistemological Beliefs and Attitudes Toward Chemistry

NASA Astrophysics Data System (ADS)

Çam, Aylin; Geban, Ömer

2011-02-01

The purpose of the study was to investigate the effectiveness of case-based learning instruction over traditionally designed chemistry instruction on eleventh grade students' epistemological beliefs and their attitudes toward chemistry as a school subject. The subjects of this study consisted of 63 eleventh grade students from two intact classes of an urban high school instructed with same teacher. Each teaching method was randomly assigned to one class. The experimental group received case-based learning and the control group received traditional instruction. At the experimental group, life cases were presented with small group format; at the control group, lecturing and discussion was carried out. The results showed that there was a significant difference between the experimental and control group with respect to their epistemological beliefs and attitudes toward chemistry as a school subject in favor of case-based learning method group. Thus, case base learning is helpful for development of students' epistemological beliefs and attitudes toward chemistry.

A Statistical Method to Distinguish Functional Brain Networks

PubMed Central

Fujita, André; Vidal, Maciel C.; Takahashi, Daniel Y.

2017-01-01

One major problem in neuroscience is the comparison of functional brain networks of different populations, e.g., distinguishing the networks of controls and patients. Traditional algorithms are based on search for isomorphism between networks, assuming that they are deterministic. However, biological networks present randomness that cannot be well modeled by those algorithms. For instance, functional brain networks of distinct subjects of the same population can be different due to individual characteristics. Moreover, networks of subjects from different populations can be generated through the same stochastic process. Thus, a better hypothesis is that networks are generated by random processes. In this case, subjects from the same group are samples from the same random process, whereas subjects from different groups are generated by distinct processes. Using this idea, we developed a statistical test called ANOGVA to test whether two or more populations of graphs are generated by the same random graph model. Our simulations' results demonstrate that we can precisely control the rate of false positives and that the test is powerful to discriminate random graphs generated by different models and parameters. The method also showed to be robust for unbalanced data. As an example, we applied ANOGVA to an fMRI dataset composed of controls and patients diagnosed with autism or Asperger. ANOGVA identified the cerebellar functional sub-network as statistically different between controls and autism (p < 0.001). PMID:28261045

A Statistical Method to Distinguish Functional Brain Networks.

PubMed

Fujita, André; Vidal, Maciel C; Takahashi, Daniel Y

2017-01-01

One major problem in neuroscience is the comparison of functional brain networks of different populations, e.g., distinguishing the networks of controls and patients. Traditional algorithms are based on search for isomorphism between networks, assuming that they are deterministic. However, biological networks present randomness that cannot be well modeled by those algorithms. For instance, functional brain networks of distinct subjects of the same population can be different due to individual characteristics. Moreover, networks of subjects from different populations can be generated through the same stochastic process. Thus, a better hypothesis is that networks are generated by random processes. In this case, subjects from the same group are samples from the same random process, whereas subjects from different groups are generated by distinct processes. Using this idea, we developed a statistical test called ANOGVA to test whether two or more populations of graphs are generated by the same random graph model. Our simulations' results demonstrate that we can precisely control the rate of false positives and that the test is powerful to discriminate random graphs generated by different models and parameters. The method also showed to be robust for unbalanced data. As an example, we applied ANOGVA to an fMRI dataset composed of controls and patients diagnosed with autism or Asperger. ANOGVA identified the cerebellar functional sub-network as statistically different between controls and autism ( p < 0.001).

Itopride therapy for functional dyspepsia: a meta-analysis.

PubMed

Huang, Xuan; Lv, Bin; Zhang, Shuo; Fan, Yi-Hong; Meng, Li-Na

2012-12-28

To evaluate the therapeutic effects of itopride vs other drugs (placebo, domperidone, mosapride) for functional dyspepsia (FD). Randomized controlled trials (RCTs) of itopride for FD were retrieved from databases. Relevant information was extracted and analyzed, using the relative risk (RR) and weighted mean deviation, as appropriate. A random or fixed effect model was used, based on the heterogeneity of the included articles, and visual inspection of funnel plots was used to evaluate publication bias. Nine RCTs enrolling 2620 FD cases were included; 1372 cases received itopride treatment and 1248 cases received placebo or other drugs (control groups). Compared with control groups, itopride had superior RR values of 1.11 [95%CI: (1.03, 1.19), P = 0.006], 1.21 [95%CI: (1.03, 1.44), P = 0.02], and 1.24 [95%CI: (1.01, 1.53), P = 0.04] for global patient assessment, postprandial fullness, and early satiety, respectively. For the Leeds Dyspepsia Questionnaire score, the weighted mean deviation was -1.38 [95%CI: (-1.75, -1.01), P < 0.01]. The incidence of adverse effects was similar in the itopride and control groups. The funnel plots for all indicators showed no evidence of publication bias. Itopride has good efficacy in terms of global patients assessment, postprandial fullness, and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions. Itopride can greatly improve FD syndromes-score.

Comparing three knowledge communication strategies - Diffusion, Dissemination and Translation - through randomized controlled studies.

PubMed

Lane, Joseph P; Stone, Vathsala I

2015-01-01

This paper describes a series of three randomized controlled case studies comparing the effectiveness of three strategies for communicating new research-based knowledge (Diffusion, Dissemination, Translation), to different Assistive Technology (AT) stakeholder groups. Pre and post intervention measures for level of knowledge use (unaware, aware, interested, using) via the LOKUS instrument, assessed the relative effectiveness of the three strategies. The latter two approaches were both more effective than diffusion but also equally effective. The results question the value added by tailoring research findings to specific audiences, and instead supports the critical yet neglected role for relevance in determining knowledge use by stakeholders.

Small laser spot versus standard laser spot photodynamic therapy for idiopathic choroidal neovascularization: a randomized controlled study.

PubMed

Li, Xiao-xin; Tao, Yong

2012-12-01

Idiopathic choroidal neovascularization (ICNV) affects young patients and thus may have a significant impact on vision and life quality over a patient's lifespan. This study was designed to compare the visual outcome and retinal pigment epithelium (RPE) damage after photodynamic therapy (PDT) with small laser spot and PDT with standard laser spot for idiopathic choroidal neovascularization (ICNV). This was a randomized controlled study. Fifty-two patients with ICNV were enrolled and randomly divided into a study group (small laser spot PDT, n = 27) and a control group (standard laser spot PDT, n = 25). Best corrected visual acuity (BCVA), optic coherence tomography (OCT) and fluorescein angiography (FA) findings were the main measurements. The patients were followed up 1 week, 1, 3, 6, 9 months and 1 year after PDT. BCVA improvement was statistically significantly higher in the study group than the control group at 6-month ((25.53 ± 15.01) letters vs. (14.71 ± 11.66) letters, P = 0.025) and 9-month follow-ups ((27.53 ± 17.78) letters vs. (15.59 ± 12.21) letters, P = 0.039). At 3- and 6-month follow-ups, the quadrants of RPE damage between the two groups varied significantly (P < 0.001 and P = 0.023, respectively). In each follow-up, the number of cases with decreased or unchanged leakage of choroidal neovascularization by FA and reduced subretinal fluid by OCT did not vary significantly between the two groups. Ten cases (37.0%) in the study group and eight cases (32.0%) in the control group suffered from recurrent CNV (P = 0.703). Better visual improvements, less RPE damage, a similar recurrent rate of CNV and change of subretinal fluid were observed in the small laser spot PDT group than in the standard laser spot PDT group for ICNV.

Community mass treatment with azithromycin for trachoma: Factors associated with change in participation of children from the first to the second round

PubMed Central

Ssemanda, Elizabeth N.; Mkocha, Harran; Levens, Joshua; Munoz, Beatriz; West, Sheila K.

2013-01-01

Background Mass drug administration (MDA) with azithromycin is an important part of trachoma control programs. Maintaining high participation among children is challenging. Aim We assessed factors identifying households with a child who changed participation from the first MDA to the second MDA compared to households where all children participated at both MDAs. Methods Two case-control comparisons were conducted in 11 Tanzanian communities, which underwent MDA in 2008 and 2009. The first case group (n=165) was a random sample of households with a child who changed from a 2008 non-participant to a 2009 participant (delayed participant). The second case group (n=165) was a random sample of households with a child who went from a 2008 participant to a 2009 non-participant (change to non-participant). Controls (n=330) were a random sample of households where all children participated in both rounds. Risk factors were assessed using questionnaires asked of children’s guardians. Logistic models with a random-intercept were used to estimate odds ratios and 95% confidence intervals. Results Households with delayed participation were more likely to be in communities with fewer treatment days (OR=2.98, 95% CI=1.80–4.92) and assigned to Community Treatment Assistants (CTA) with a wide area to cover (OR=1.88, 95% CI=1.09–3.23). Households with change to non-participation were more likely to live further from the distribution site (OR=3.17, 95% CI=1.19–8.46), have the guardian born outside the village with short-term residency (OR=2.64, 95% CI=1.32–5.31), and be assigned to a male CTA (OR=1.75, 95% CI=1.08–2.83). Conclusions Factors related to program accessibility were associated with delayed participation and maintaining participation. PMID:26462290

Benefits of using intrathecal buprenorphine.

PubMed

Rabiee, Seyed Mozaffar; Alijanpour, Ebrahim; Jabbari, Ali; Rostami, Sara

2014-01-01

General anesthesia draws attention to the most commonly used modalities for post cesarean delivery pain relief in systemic administration of opioids, while the administration of small dose of intrathecal opioid during spinal anesthesia can be a possible alternative. The aim of this study was to evaluate the effects of buprenorphine on cesarean section prescribed intrathecally. This double blind randomized clinical trial study was conducted in patients for cesarean section under spinal anesthesia. The patients were randomly divided into case and control groups. Case group (208 patients) received 65-70 mg of 5% lidocaine plus 0.2 ml of buprenorphine while the same amount of 5% lidocaine diluted with 0.2 ml of normal saline was given to 234 cases in the control group. Hemodynamic changes and neonatal APGAR scores (Appearance, Pulse, Grimace, Activity, Respiration) were recorded. Pain score was recorded according to the visual analog scale. This study was registered in the Iranian Registry of clinical Trials; IRCT2013022112552N1. The mean age of case and control groups was 24.4±5.38 and 26.84±5.42 years, respectively. Systolic blood pressure was not significantly different until the 45th minute but diastolic blood pressure showed a significant difference at the 15th and the 60th minutes (P<0.001). Heart rate changes were significantly different between cases and controls at the initial 5th, 15th and after 60th minutes (P<0.001). Pain-free period was significantly different between two groups (1.25 h versus 18.73 h) (P<0.001). The results show that prescription of intratechal buprenorphine prolongs the duration of analgesia without any significant considerable side effects.

Effect of Breathing Technique of Blowing on the Extent of Damage to the Perineum at the Moment of Delivery: A Randomized Clinical Trial

PubMed Central

Ahmadi, Zohre; Torkzahrani, Shahnaz; Roosta, Firouze; Shakeri, Nezhat; Mhmoodi, Zohre

2017-01-01

Introduction: One of the important tasks in managing labor is the protection of perineum. An important variable affecting this outcome is maternal pushing during the second stage of labor. This study was done to investigate the effect of breathing technique on perineal damage extention in laboring Iranian women. Materials and Methods: This randomized clinical trial was performed on 166 nulliparous pregnant women who had reached full-term pregnancy, had low risk pregnancy, and were candidates for vaginal delivery in two following groups: using breathing techniques (case group) and valsalva maneuver (control group). In the control group, pushing was done with holding the breath. In the case group, the women were asked to take 2 deep abdominal breaths at the onset of pain, then take another deep breath, and push 4–5 seconds with the open mouth while controlling exhalation. From the crowning stage onward, the women were directed to control their pushing, and do the blowing technique. Results: According to the results, intact perineum was more observed in the case group (P = 0.002). Posterior tears (Grade 1, 2, and 3) was considerably higher in the control group (P = 0.003). Anterior tears (labias) and episiotomy were not significantly different in the two groups. Conclusions: It was concluded that breathing technique of blowing can be a good alternative to Valsalva maneuver in order to reduce perineal damage in laboring women. PMID:28382061

Clinically observed chickenpox and the risk of childhood-onset multiple sclerosis.

PubMed

Mikaeloff, Yann; Caridade, Guillaume; Suissa, Samy; Tardieu, Marc

2009-05-15

The authors conducted a population-based case-control study to investigate whether clinically observed chickenpox, linked with a level of intensity for clinical expression, increases the risk of multiple sclerosis (MS) in childhood. The cases were MS patients whose disease onset occurred between 1994 and 2003, before age 16 years, in France. Each case was matched for age, sex, and geographic origin with as many as 12 controls randomly selected from the general population. Information about clinically observed chickenpox in cases and controls before the index date regarding onset of MS was collected with a standardized questionnaire and was checked against health certificates. Conditional logistic regression was used to estimate the odds ratio for an association between MS and chickenpox. The 137 MS cases were matched with 1,061 controls. Clinically observed chickenpox had occurred in 76.6% of the cases and 84.9% of their matched controls. The adjusted odds ratio of MS onset associated with chickenpox occurrence was 0.58 (95% confidence interval: 0.36, 0.92). The authors concluded that clinically observed chickenpox was associated with a lower risk of childhood-onset MS in a French population.

Family-Based Treatment of a 17-Year-Old Twin Presenting with Emerging Anorexia Nervosa: A Case Study Using the "Maudsley Method"

ERIC Educational Resources Information Center

Loeb, Katharine L.; Hirsch, Alicia M.; Greif, Rebecca; Hildebrandt, Thomas B.

2009-01-01

This article describes the successful application of family-based treatment (FBT) for a 17-year-old identical twin presenting with a 4-month history of clinically significant symptoms of anorexia nervosa (AN). FBT is a manualized treatment that has been studied in randomized controlled trials for adolescents with AN. This case study illustrates…

A philosophical argument against evidence-based policy.

PubMed

Anjum, Rani Lill; Mumford, Stephen D

2017-10-01

Evidence-based medicine has two components. The methodological or ontological component consists of randomized controlled trials and their systematic review. This makes use of a difference-making conception of cause. But there is also a policy component that makes a recommendation for uniform intervention, based on the evidence from randomized controlled trials. The policy side of evidence-based medicine is basically a form of rule utilitarianism. But it is then subject to an objection from Smart that rule utilitarianism inevitably collapses. If one assumes (1) you should recommend the intervention that has brought most benefit (the core of evidence-based policy making), (2) individual variation (acknowledged by use of randomization) and (3) no intervention benefits all (contingent but true), then the objection can be brought to bear. A utility maximizer should always ignore the rule in an individual case where greater benefit can be secured through doing so. In the medical case, this would mean that a clinician who knows that a patient would not benefit from the recommended intervention has good reason to ignore the recommendation. This is indeed the feeling of many clinicians who would like to offer other interventions but for an aversion to breaking clinical guidelines. © 2016 John Wiley & Sons, Ltd.

Tetracycline treatment of type III prostatitis nanobacteria infection of 100 cases report

NASA Astrophysics Data System (ADS)

Guo, Junyi; Li, Chongxian; Wu, Baisuo; Hao, Shaojun; Ming, Aimin; Zhang, Xinji; Li, Wenjun; Zhang, Zhengchen

2018-04-01

To investigate the efficacy of tetracycline treatment of nanobacterial infection in 100 cases of type III prostatitis. randomly divided into treatment group and control group with double blind method, the treatment group was given Tetracycline Tablets 250mg, oral, 2 times a day; the control group were treated with Levofloxacin Tablets 0.lg, oral, 2 times a day; observation of curative effect of two groups of patients after 1 months of treatment. after the treatment group patients NIH-CPSI score and pain, urinary symptoms and quality of life scores were significantly lower than that of control group (P<0.01); after treatment, observation group lecithin corpuscle scale score was significantly higher than the control group (P<0.05). The treatment group and the control group patients after prostate fluid and cultured positive cases of nanobacterial numbers were 21 (21%) and 100 cases (100%), the positive rate of nanobacteria in observation group was significantly lower than the control group (P<0.05). There is a good effect Tetracycline Tablets treatment of nanobacterial infection of type III prostatitis.

Differences between blood donors and a population sample: implications for case-control studies.

PubMed

Golding, Jean; Northstone, Kate; Miller, Laura L; Davey Smith, George; Pembrey, Marcus

2013-08-01

Selecting appropriate controls for studies of genetic variation in case series is important. The two major candidates involve the use of blood donors or a random sample of the population. We compare and contrast the two different populations of controls for studies of genetic variation using data from parents enrolled in the Avon Longitudinal Study of Parents and Children (ALSPAC). In addition we compute different biases using a series of hypothetical assumptions. The study subjects who had been blood donors differed markedly from the general population in social, health-related, anthropometric, and personality-related variables. Using theoretical examples, we show that blood donors are a poor control group for non-genetic studies of diseases related to environmentally, behaviourally, or socially patterned exposures. However, we show that if blood donors are used as controls in genetic studies, these factors are unlikely to make a major difference in detecting true associations with relatively rare disorders (cumulative incidence through life of <10%). Nevertheless, for more common disorders, the reduction in accuracy resulting from the inclusion in any control population of individuals who have or will develop the disease in question can create a greater bias than can socially patterned factors. Information about the medical history of a control and the parents of the control (as a proxy for whether the control will develop the disease) is more important with regard to the choice of controls than whether the controls are a random population sample or blood donors.

Circulating Selenium and Prostate Cancer Risk: A Mendelian Randomization Analysis.

PubMed

Yarmolinsky, James; Bonilla, Carolina; Haycock, Philip C; Langdon, Ryan J Q; Lotta, Luca A; Langenberg, Claudia; Relton, Caroline L; Lewis, Sarah J; Evans, David M; Davey Smith, George; Martin, Richard M

2018-05-17

In the Selenium and Vitamin E Cancer Prevention Trial (SELECT), selenium supplementation (causing a median 114 μg/L increase in circulating selenium) did not lower overall prostate cancer risk, but increased risk of high-grade prostate cancer and type 2 diabetes. Mendelian randomization analysis uses genetic variants to proxy modifiable risk factors and can strengthen causal inference in observational studies. We constructed a genetic instrument comprising 11 single nucleotide polymorphisms robustly (P < 5 × 10-8) associated with circulating selenium in genome-wide association studies. In a Mendelian randomization analysis of 72 729 men in the PRACTICAL Consortium (44 825 case subjects, 27 904 control subjects), 114 μg/L higher genetically elevated circulating selenium was not associated with prostate cancer (odds ratio [OR] = 1.01, 95% confidence interval [CI] = 0.89 to 1.13). In concordance with findings from SELECT, selenium was weakly associated with advanced (including high-grade) prostate cancer (OR = 1.21, 95% CI = 0.98 to 1.49) and type 2 diabetes (OR = 1.18, 95% CI = 0.97 to 1.43; in a type 2 diabetes genome-wide association study meta-analysis with up to 49 266 case subjects and 249 906 control subjects). Our Mendelian randomization analyses do not support a role for selenium supplementation in prostate cancer prevention and suggest that supplementation could have adverse effects on risks of advanced prostate cancer and type 2 diabetes.

CR-Calculus and adaptive array theory applied to MIMO random vibration control tests

NASA Astrophysics Data System (ADS)

Musella, U.; Manzato, S.; Peeters, B.; Guillaume, P.

2016-09-01

Performing Multiple-Input Multiple-Output (MIMO) tests to reproduce the vibration environment in a user-defined number of control points of a unit under test is necessary in applications where a realistic environment replication has to be achieved. MIMO tests require vibration control strategies to calculate the required drive signal vector that gives an acceptable replication of the target. This target is a (complex) vector with magnitude and phase information at the control points for MIMO Sine Control tests while in MIMO Random Control tests, in the most general case, the target is a complete spectral density matrix. The idea behind this work is to tailor a MIMO random vibration control approach that can be generalized to other MIMO tests, e.g. MIMO Sine and MIMO Time Waveform Replication. In this work the approach is to use gradient-based procedures over the complex space, applying the so called CR-Calculus and the adaptive array theory. With this approach it is possible to better control the process performances allowing the step-by-step Jacobian Matrix update. The theoretical bases behind the work are followed by an application of the developed method to a two-exciter two-axis system and by performance comparisons with standard methods.

On the Analysis of Case-Control Studies in Cluster-correlated Data Settings.

PubMed

Haneuse, Sebastien; Rivera-Rodriguez, Claudia

2018-01-01

In resource-limited settings, long-term evaluation of national antiretroviral treatment (ART) programs often relies on aggregated data, the analysis of which may be subject to ecological bias. As researchers and policy makers consider evaluating individual-level outcomes such as treatment adherence or mortality, the well-known case-control design is appealing in that it provides efficiency gains over random sampling. In the context that motivates this article, valid estimation and inference requires acknowledging any clustering, although, to our knowledge, no statistical methods have been published for the analysis of case-control data for which the underlying population exhibits clustering. Furthermore, in the specific context of an ongoing collaboration in Malawi, rather than performing case-control sampling across all clinics, case-control sampling within clinics has been suggested as a more practical strategy. To our knowledge, although similar outcome-dependent sampling schemes have been described in the literature, a case-control design specific to correlated data settings is new. In this article, we describe this design, discuss balanced versus unbalanced sampling techniques, and provide a general approach to analyzing case-control studies in cluster-correlated settings based on inverse probability-weighted generalized estimating equations. Inference is based on a robust sandwich estimator with correlation parameters estimated to ensure appropriate accounting of the outcome-dependent sampling scheme. We conduct comprehensive simulations, based in part on real data on a sample of N = 78,155 program registrants in Malawi between 2005 and 2007, to evaluate small-sample operating characteristics and potential trade-offs associated with standard case-control sampling or when case-control sampling is performed within clusters.

Nutrient intake and gastric cancer risk: a case-control study in Spain.

PubMed

Ramón, J M; Serra-Majem, L; Cerdó, C; Oromí, J

1993-12-01

A case-control study of dietary factors and gastric cancer was conducted between September 1986 and March 1989 in the Barcelona metropolitan area, Spain. In all 117 cases with histologically confirmed diagnosis of gastric adenocarcinoma were matched on sex, age and possession of a telephone to 234 population controls. Of the controls 188 (80.3%) were selected by random digit telephone dialing and 46 (19.7%) by neighbourhood of residence. Information about frequency and amount of consumption of 89 alimentary items was gathered by questionnaire, and cases and controls were interviewed in their homes by trained interviewers. The gastric cancer risk decreased in proportion to vitamin C intake. In multivariate analysis adjusting for major covariables, energy and vitamin A intake, the estimated odds ratio (OR) for the upper quartile of vitamin C intake was 0.3 (95% confidence interval [CI]: 0.1-0.8). After adjustment for major covariables, calories and vitamin C intake, vitamin A did not show significant association with the gastric cancer risk. Our findings are consistent with previous case-control studies and with the hypothesis that vitamin C may inhibit the intragastric nitrosation process.

Hemostatic Agents in Periapical Surgery: A Randomized Study of Gauze Impregnated in Epinephrine versus Aluminum Chloride.

PubMed

Menéndez-Nieto, Isabel; Cervera-Ballester, Juan; Maestre-Ferrín, Laura; Blaya-Tárraga, Juan Antonio; Peñarrocha-Oltra, David; Peñarrocha-Diago, Miguel

2016-11-01

Adequate bleeding control is essential for the success of periapical surgery. The aim of this study was to evaluate the effects of 2 hemostatic agents on the outcome of periapical surgery and their relationship with patient and teeth parameters. A prospective study was designed with 2 randomized parallel groups, depending on the hemostatic agent used: gauze impregnated in epinephrine (epinephrine group) and aluminum chloride (aluminum chloride group). The analysis of the hemorrhage control was judged before and after the application of the hemostatic agents by the surgeon, and 2 examiners independently recorded it as adequate (complete hemorrhage control) or inadequate (incomplete hemorrhage control). Ninety-nine patients with a periradicular lesion were enrolled in this study and divided into 2 groups: gauze impregnated in epinephrine in 48 patients (epinephrine group) or aluminum chloride in 51 (aluminum chloride group). In epinephrine group adequate hemostasis was achieved in 25 cases, and in aluminum chloride group it was achieved in 37 cases (P < .05). The outcome was better in the aluminum chloride group than in the gauze impregnated in epinephrine group. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A serum protein-based algorithm for the detection of Alzheimer disease.

PubMed

O'Bryant, Sid E; Xiao, Guanghua; Barber, Robert; Reisch, Joan; Doody, Rachelle; Fairchild, Thomas; Adams, Perrie; Waring, Steven; Diaz-Arrastia, Ramon

2010-09-01

To develop an algorithm that separates patients with Alzheimer disease (AD) from controls. Longitudinal case-control study. The Texas Alzheimer's Research Consortium project. Patients  We analyzed serum protein-based multiplex biomarker data from 197 patients diagnosed with AD and 203 controls. Main Outcome Measure  The total sample was randomized equally into training and test sets and random forest methods were applied to the training set to create a biomarker risk score. The biomarker risk score had a sensitivity and specificity of 0.80 and 0.91, respectively, and an area under the curve of 0.91 in detecting AD. When age, sex, education, and APOE status were added to the algorithm, the sensitivity, specificity, and area under the curve were 0.94, 0.84, and 0.95, respectively. These initial data suggest that serum protein-based biomarkers can be combined with clinical information to accurately classify AD. A disproportionate number of inflammatory and vascular markers were weighted most heavily in the analyses. Additionally, these markers consistently distinguished cases from controls in significant analysis of microarray, logistic regression, and Wilcoxon analyses, suggesting the existence of an inflammatory-related endophenotype of AD that may provide targeted therapeutic opportunities for this subset of patients.

Exposure to residential electric and magnetic fields and risk of childhood leukemia.

PubMed

London, S J; Thomas, D C; Bowman, J D; Sobel, E; Cheng, T C; Peters, J M

1991-11-01

The relation between exposure to electric and magnetic fields in the home, as assessed by measurements, wiring configuration, and self-reported appliance use, and risk of leukemia was investigated in a case-control study among children from birth to age 10 years in Los Angeles County, California. Cases were ascertained through a population-based tumor registry from 1980 to 1987. Controls were drawn from friends and by random digit dialing. Interviews were obtained from 232 cases and 232 controls. Available for analysis were measurements of the magnetic field in the child's bedroom over 24 hours or longer (164 cases and 144 controls), spot measurements of magnetic and electric fields (140 cases and 109 controls), and wiring configuration (219 cases and 207 controls). No clear associations between leukemia risk and measured magnetic or electric fields were seen. An association between the Denver Wertheimer-Leeper wiring configuration and childhood leukemia risk was observed (odds ratio for very high relative to very low current and underground configuration combined = 2.15, 95% confidence interval 1.08-4.28; p for trend = 0.008) and was not substantially altered by adjustment for potential confounding factors. Cases were more likely than controls to report use of several appliances that produce high electric and magnetic fields. Our results support an association between childhood leukemia risk and wiring configuration, but not direct measurements of electric and magnetic fields.

[Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

PubMed

Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

2015-06-01

To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group. BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial.

PubMed

Muñoz, H; Guerra, S; Perez-Vaquero, P; Valero Martinez, C; Aizpuru, F; Lopez-Picado, A

2014-02-01

Breech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version. A randomized, double-blind, controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0-10) after external cephalic version. Sixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia. Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia. Copyright © 2013 Elsevier Ltd. All rights reserved.

Efficacy of a virtual assistance-based lifestyle intervention in reducing risk factors for Type 2 diabetes in young employees in the information technology industry in India: LIMIT, a randomized controlled trial.

PubMed

Limaye, T; Kumaran, K; Joglekar, C; Bhat, D; Kulkarni, R; Nanivadekar, A; Yajnik, C

2017-04-01

To investigate a virtual assistance-based lifestyle intervention to reduce risk factors for Type 2 diabetes in young employees in the information technology industry in India. LIMIT (Lifestyle Modification in Information Technology) was a parallel-group, partially blinded, randomized controlled trial. Employees in the information technology industry with ≥3 risk factors (family history of cardiometabolic disease, overweight/obesity, high blood pressure, impaired fasting glucose, hypertriglyceridaemia, high LDL cholesterol and low HDL cholesterol) from two industries were randomized to a control or an intervention (1:1) group. After initial lifestyle advice, the intervention group additionally received reinforcement through mobile phone messages (three per week) and e-mails (two per week) for 1 year. The primary outcome was change in prevalence of overweight/obesity, analysed by intention to treat. Of 437 employees screened (mean age 36.2 ± 9.3 years; 74.8% men), 265 (61.0%) were eligible and randomized into control (n=132) or intervention (n=133) group. After 1 year, the prevalence of overweight/obesity reduced by 6.0% in the intervention group and increased by 6.8% in the control group (risk difference 11.2%; 95% CI 1.2-21.1; P=0.042). There were also significant improvements in lifestyle measurements, waist circumference, and total and LDL cholesterol in the intervention group. The number-needed-to-treat to prevent one case of overweight/obesity in 1 year was 9 (95% CI 5-82), with an incremental cost of INR10665 (£112.30) per case treated/prevented. A total of 98% of participants found the intervention acceptable. A virtual assistance-based lifestyle intervention was effective, cost-effective and acceptable in reducing risk factors for diabetes in young employees in the information technology industry, and is potentially scalable. © 2016 Diabetes UK.

Probabilistic DHP adaptive critic for nonlinear stochastic control systems.

PubMed

Herzallah, Randa

2013-06-01

Following the recently developed algorithms for fully probabilistic control design for general dynamic stochastic systems (Herzallah & Káarnáy, 2011; Kárný, 1996), this paper presents the solution to the probabilistic dual heuristic programming (DHP) adaptive critic method (Herzallah & Káarnáy, 2011) and randomized control algorithm for stochastic nonlinear dynamical systems. The purpose of the randomized control input design is to make the joint probability density function of the closed loop system as close as possible to a predetermined ideal joint probability density function. This paper completes the previous work (Herzallah & Káarnáy, 2011; Kárný, 1996) by formulating and solving the fully probabilistic control design problem on the more general case of nonlinear stochastic discrete time systems. A simulated example is used to demonstrate the use of the algorithm and encouraging results have been obtained. Copyright © 2013 Elsevier Ltd. All rights reserved.

Treatment of Multiple-Resistant and/or Recurrent Cutaneous Warts With Squaric Acid Dibutylester: A Randomized, Double-blind, Vehicle-controlled Clinical Trial.

PubMed

DallʼOglio, Federica; Luca, Maria; Barresi, Sebastiano; Micali, Giuseppe

Contact immunotherapy with squaric acid dibutylester (SADBE) for cutaneous warts has been reported to be effective, although no controlled studies are available so far. The aim of this study was to evaluate the efficacy of SADBE on cutaneous warts by a randomized, double-blind, vehicle-controlled, clinical trial. Thirty-six patients were randomly assigned to SADBE (18 cases) or vehicle (18 cases) group. At 8 weeks, subjects were clinically evaluated for number/size reduction rate and for Investigator Global Assessment. Those who showed improvement extended therapy up to 40 weeks, whereas those who showed unresponsiveness were either switched to SADBE application for up to 48 weeks (if in the vehicle group) or withdrawn from the study (if under SADBE). At 8 weeks, a significant reduction in wart number (P = 0.020) and size (P = 0.010) in the SADBE group, with clearing rates of 41.2% versus 12.5% in the SADBE and vehicle groups, respectively, was observed. Nine remaining SADBE responders who underwent treatment extension up to 40 weeks achieved clearing versus 2 patients of the vehicle group who remained unresponsive. Clearing was obtained in 81.8% of patients who underwent previous ineffective vehicle treatment and had been switched to SADBE. Squaric acid dibutylester is an effective therapeutic option and is significantly more effective than vehicle.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

PubMed

Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

2018-02-01

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

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

PubMed

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

2009-11-20

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

Methodological and Ethical Challenges in a Web-Based Randomized Controlled Trial of a Domestic Violence Intervention

PubMed Central

Valpied, Jodie; Koziol-McLain, Jane; Glass, Nancy; Hegarty, Kelsey

2017-01-01

The use of Web-based methods to deliver and evaluate interventions is growing in popularity, particularly in a health care context. They have shown particular promise in responding to sensitive or stigmatized issues such as mental health and sexually transmitted infections. In the field of domestic violence (DV), however, the idea of delivering and evaluating interventions via the Web is still relatively new. Little is known about how to successfully navigate several challenges encountered by the researchers while working in this area. This paper uses the case study of I-DECIDE, a Web-based healthy relationship tool and safety decision aid for women experiencing DV, developed in Australia. The I-DECIDE website has recently been evaluated through a randomized controlled trial, and we outline some of the methodological and ethical challenges encountered during recruitment, retention, and evaluation. We suggest that with careful consideration of these issues, randomized controlled trials can be safely conducted via the Web in this sensitive area. PMID:28351830

Clustering and Phase Transitions on a Neutral Landscape

NASA Astrophysics Data System (ADS)

Scott, Adam; King, Dawn; Maric, Nevena; Bahar, Sonya

2012-02-01

The problem of speciation and species aggregation on a neutral landscape, subject to random mutational fluctuations rather than selective drive, has been a focus of research since the seminal work of Kimura on genetic drift. These ideas have received increased attention due to the more recent development of a neutral ecological theory by Hubbell. De Aguiar et al. recently demonstrated, in a computational model, that speciation can occur under neutral conditions; this study bears some comparison with more mathematical studies of clustering on neutral landscapes in the context of branching and annihilating random walks. Here, we show that clustering can occur on a neutral landscape where the dimensions specify the simulated organisms' phenotypes. Unlike the De Aguiar et al. model, we simulate sympatric speciation: the organisms cluster phenotypically, but are not spatially separated. Moreover, we find that clustering occurs not only in the case of assortative mating, but also in the case of asexual fission. Clustering is not observed in a control case where organisms can mate randomly. We find that the population size and the number of clusters undergo phase-transition-like behavior as the maximum mutation size is varied.

[Computer-assisted education in problem-solving in neurology; a randomized educational study].

PubMed

Weverling, G J; Stam, J; ten Cate, T J; van Crevel, H

1996-02-24

To determine the effect of computer-based medical teaching (CBMT) as a supplementary method to teach clinical problem-solving during the clerkship in neurology. Randomized controlled blinded study. Academic Medical Centre, Amsterdam, the Netherlands. 103 Students were assigned at random to a group with access to CBMT and a control group. CBMT consisted of 20 computer-simulated patients with neurological diseases, and was permanently available during five weeks to students in the CBMT group. The ability to recognize and solve neurological problems was assessed with two free-response tests, scored by two blinded observers. The CBMT students scored significantly better on the test related to the CBMT cases (mean score 7.5 on a zero to 10 point scale; control group 6.2; p < 0.001). There was no significant difference on the control test not related to the problems practised with CBMT. CBMT can be an effective method for teaching clinical problem-solving, when used as a supplementary teaching facility during a clinical clerkship. The increased ability to solve problems learned by CBMT had no demonstrable effect on the performance with other neurological problems.

Influence of decreased fibrinolytic activity and plasminogen activator inhibitor-1 4G/5G polymorphism on the risk of venous thrombosis.

PubMed

Vuckovic, Biljana A; Djeric, Mirjana J; Tomic, Branko V; Djordjevic, Valentina J; Bajkin, Branislav V; Mitic, Gorana P

2018-01-01

: Objective of our study is to determine whether decreased fibrinolytic activity or plasminogen activator inhibitor (PAI)-1 4G/5G polymorphism influence the risk of venous thrombosis.Our case-control study included 100 patients with venous thrombosis, and 100 random controls. When patients were compared with random controls, unconditional logistic regression was used to calculate odds ratios (ORs) with 95% confidence intervals (CIs).Decreased fibrinolytic activity yielded a 2.7-fold increase in risk for venous thrombosis than physiological fibrinolytic activity (OR 2.70; 95% CI 1.22-5.98), when comparing patients with random controls. Adjustment for several putative confounders did not change the estimate (OR 3.02; 95% CI 1.26-7.22). Analysis of venous thrombotic risk influenced by PAI-1 genotype, showed no influence of PAI-1 4G/5G gene variant in comparison with 5G/5G genotype (OR 0.57 95% CI; 0.27-1.20).Decreased fibrinolytic activity increased, whereas PAI-1 4G/5G polymorphism did not influence venous thrombosis risk in this study.

Is case-chaos methodology an appropriate alternative to conventional case-control studies for investigating outbreaks?

PubMed

Edelstein, Michael; Wallensten, Anders; Kühlmann-Berenzon, Sharon

2014-08-15

Case-chaos methodology is a proposed alternative to case-control studies that simulates controls by randomly reshuffling the exposures of cases. We evaluated the method using data on outbreaks in Sweden. We identified 5 case-control studies from foodborne illness outbreaks that occurred between 2005 and 2012. Using case-chaos methodology, we calculated odds ratios 1,000 times for each exposure. We used the median as the point estimate and the 2.5th and 97.5th percentiles as the confidence interval. We compared case-chaos matched odds ratios with their respective case-control odds ratios in terms of statistical significance. Using Spearman's correlation, we estimated the correlation between matched odds ratios and the proportion of cases exposed to each exposure and quantified the relationship between the 2 using a normal linear mixed model. Each case-control study identified an outbreak vehicle (odds ratios = 4.9-45). Case-chaos methodology identified the outbreak vehicle 3 out of 5 times. It identified significant associations in 22 of 113 exposures that were not associated with outcome and 5 of 18 exposures that were significantly associated with outcome. Log matched odds ratios correlated with their respective proportion of cases exposed (Spearman ρ = 0.91) and increased significantly with the proportion of cases exposed (b = 0.054). Case-chaos methodology missed the outbreak source 2 of 5 times and identified spurious associations between a number of exposures and outcome. Measures of association correlated with the proportion of cases exposed. We recommended against using case-chaos analysis during outbreak investigations. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Systematic review on randomized controlled clinical trials of acupuncture therapy for neurovascular headache.

PubMed

Zhao, Lei; Guo, Yi; Wang, Wei; Yan, Li-juan

2011-08-01

To evaluate the effectiveness of acupuncture as a treatment for neurovascular headache and to analyze the current situation related to acupuncture treatment. PubMed database (1966-2010), EMBASE database (1986-2010), Cochrane Library (Issue 1, 2010), Chinese Biomedical Literature Database (1979-2010), China HowNet Knowledge Database (1979-2010), VIP Journals Database (1989-2010), and Wanfang database (1998-2010) were retrieved. Randomized or quasi-randomized controlled studies were included. The priority was given to high-quality randomized, controlled trials. Statistical outcome indicators were measured using RevMan 5.0.20 software. A total of 16 articles and 1 535 cases were included. Meta-analysis showed a significant difference between the acupuncture therapy and Western medicine therapy [combined RR (random efficacy model)=1.46, 95% CI (1.21, 1.75), Z=3.96, P<0.0001], indicating an obvious superior effect of the acupuncture therapy; significant difference also existed between the comprehensive acupuncture therapy and acupuncture therapy alone [combined RR (fixed efficacy model)=3.35, 95% CI (1.92, 5.82), Z=4.28, P<0.0001], indicating that acupuncture combined with other therapies, such as points injection, scalp acupuncture, auricular acupuncture, etc., were superior to the conventional body acupuncture therapy alone. The inclusion of limited clinical studies had verified the efficacy of acupuncture in the treatment of neurovascular headache. Although acupuncture or its combined therapies provides certain advantages, most clinical studies are of small sample sizes. Large sample size, randomized, controlled trials are needed in the future for more definitive results.

[Effect of jian-gan-le on advanced schistosomiasis].

PubMed

He, Zheng-Wen; Wang, You-Bin; Huang, Wen-Jun

2011-06-01

A total of 80 cases of advanced schistosomiasis were selected and divided into an experiment group and a control group, 40 cases each group, by the random sampling method. The patients in the experiment group were administered with Jian-gan-le, and the patients in the control group received compound purple granules. In the experiment group, the curative rate was 25.0%, the improving rate was 70.0%, the inefficacy rate was 5%, and the efficiency rate was 95.0%. In the control group, the curative rate was 12.5%, the improving rate was 75%, the inefficacy rate was 12.5%. There was no statistic difference between the 2 groups (P all > 0.05). The expense was cheaper in the experiment group than in the control group.

Risk Factors Profile of Shoulder Dystocia in Oman: A Case Control Study

PubMed Central

Al-Khaduri, Maha M.; Abudraz, Rania Mohammed; Al-Farsi, Yahya M.

2014-01-01

Objective This study aimed to assess the risk factor profile of shoulder dystocia and associated neonatal complications in Oman, a developing Arab country. Methods A retrospective case-control study was conducted among 111 cases with dystocia and 111 controls, identified during 1994-2006 period in a tertiary care hospital in Oman. Controls were randomly selected among women who did not have dystocia, and were matched to cases on the day of delivery. Data related to potential risk factors, delivery, and obstetric complications were collected. Results Dystocia was significantly associated with older maternal age, higher parity, larger BMI, diabetes, and previous record of dystocia. In addition, dystocia was associated more with vacuum and forceps deliveries. Routine traction (51%) was the most used manoeuvre. Among dystocia cases, 13% were associated with fetal complications of which Erb’s Palsy was the most prevalent (79%). Conclusion Our finding of significant associations with risk factors lays out the ground to develop a predictability index for shoulder dystocia, which would help in making it preventable. Further p rospective studies are required to confirm the obtained results. PMID:25337307

[Is Mapuche ethnicity a risk factor for hip fracture in aged?].

PubMed

Sapunar, Jorge; Bravo, Paulina; Schneider, Hermann; Jiménez, Marcela

2003-10-01

Ethnic factors are involved in the risk for osteoporosis and hip fracture. To assess the effect of Mapuche ethnicity on the risk of hip fracture. A case control study. Cases were subjects over 55 years of age admitted, during one year, for hip fracture not associated to major trauma or tumors. Controls were randomly chosen from other hospital services and paired for age with cases. The magnitude of the association between ethnicity and hip fracture was expressed as odds ratio in a logistic regression model. In the study period, 156 cases with hip fracture were admitted. The proportion of subjects with Mapuche origin was significantly lower among cases than controls (11.8 and 26.5% respectively, p < 0.001). In the logistic regression model, Mapuche ethnicity was associated with hip fracture with an odds radio of 0.14 (p = 0.03, 95% CI 0.03-0.8). In this sample, Mapuche ethnicity is a protective factor for hip fracture.

Vitamin C Intake and Pancreatic Cancer Risk: A Meta-Analysis of Published Case-Control and Cohort Studies.

PubMed

Hua, Yong-Fei; Wang, Gao-Qing; Jiang, Wei; Huang, Jing; Chen, Guo-Chong; Lu, Cai-De

2016-01-01

Observational studies inconsistently reported the relationship between vitamin C intake and risk of pancreatic cancer. We conducted a meta-analysis of published case-control and cohort studies to quantify the association. Potentially eligible studies were found on PubMed and EMBASE databases through May 31, 2015. A random-effects model was assigned to compute summary point estimates with corresponding 95% confidence intervals (CIs). Subgroup and meta-regression analyses were also performed to explore sources of heterogeneity. Our final analyses included 20 observational studies comprising nearly 5 thousand cases of pancreatic cancer. When comparing the highest with the lowest categories of vitamin C intake, the summary odds ratio/relative risk for case-control studies (14 studies), cohort studies (6 studies) and all studies combined was 0.58 (95% CI: 0.52-0.66), 0.93 (95% CI: 0.78-1.11) and 0.66 (95% CI: 0.58-0.75), respectively. The difference in the findings between case-control and cohort studies was statistically significant (P < .001). Possible publication bias was shown in the meta-analysis of case-control studies. There is insufficient evidence to conclude any relationship between vitamin C intake and risk of pancreatic cancer. The strong inverse association observed in case-control studies may be affected by biases (eg, recall and selection biases) that particularly affect case-control studies and/or potential publication bias. Future prospective studies of vitamin C intake and pancreatic cancer are needed.

Comparison of Address-based Sampling and Random-digit Dialing Methods for Recruiting Young Men as Controls in a Case-Control Study of Testicular Cancer Susceptibility

PubMed Central

Clagett, Bartholt; Nathanson, Katherine L.; Ciosek, Stephanie L.; McDermoth, Monique; Vaughn, David J.; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A.

2013-01-01

Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-phone numbers and address-based sampling (ABS), to recruit primarily white men aged 18–55 years into a study of testicular cancer susceptibility conducted in the Philadelphia, Pennsylvania, metropolitan area between 2009 and 2012. With few exceptions, eligible and enrolled controls recruited by means of RDD and ABS were similar with regard to characteristics for which data were collected on the screening survey. While we find ABS to be a comparably effective method of recruiting young males compared with landline RDD, we acknowledge the potential impact that selection bias may have had on our results because of poor overall response rates, which ranged from 11.4% for landline RDD to 1.7% for ABS. PMID:24008901

Measles incidence, case fatality, and delayed mortality in children with or without vitamin A supplementation in rural Ghana.

PubMed

Dollimore, N; Cutts, F; Binka, F N; Ross, D A; Morris, S S; Smith, P G

1997-10-15

Data on measles incidence, acute case fatality, and delayed mortality were collected on 25,443 children aged 0-95 months during the course of a community-based, double-blind, placebo-controlled, randomized trial of vitamin A supplementation in rural, northern Ghana between 1989 and 1991. Measles vaccine coverage in these children was 48%. The overall estimated measles incidence rate was 24.3 per 1,000 child-years, and acute case fatality was 15.7%. There was not significantly increased mortality in survivors of the acute phase of measles compared with controls (rate ratio = 1.22, 95% confidence interval (CI) 0.65-2.30). Reported incidence rates and case fatality were higher in families with low paternal education, in the dry season, and in unvaccinated children, and case fatality was higher in malnourished children. There was no sex difference in incidence, but acute case fatality was somewhat higher in girls than boys (adjusted odds ratio = 1.3, 95% CI 0.9-2.1). Measles incidence was lower in vitamin A-supplemented groups (23.6 per 1,000 child-years) than in placebo groups (28.9 per 1,000 child-years), but this difference was not statistically significant (p = 0.33). Among 946 measles cases in clusters randomized to receive vitamin A or placebo, there was no marked difference in acute measles case fatality between vitamin A-supplemented and placebo groups (15.4% vs. 14.5%, respectively). The biologic effects of vitamin A supplemented on the subsequent clinical manifestations and severity of measles need further elucidation.

Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial.

PubMed

Malte, Carol A; Cox, Koriann; Saxon, Andrew J

2017-05-01

This study sought to determine whether homeless veterans entering Veterans Affairs (VA) substance use treatment randomized to intensive addiction/housing case management (AHCM) had improved housing, substance use, mental health, and functional outcomes and lower acute health care utilization, compared to a housing support group (HSG) control. Homeless veterans (n = 181) entering outpatient VA substance use treatment were randomized to AHCM and HSG and received treatment for 12 months. AHCM provided individualized housing, substance use and mental health case management, life skills training, and community outreach. The control condition was a weekly drop-in housing support group. Adjusted longitudinal analyses compared groups on baseline to month 12 change in percentage of days housed and functional status, substance use, and mental health outcomes (36-Item Short-Form Health Survey; Addiction Severity Index [ASI]). Negative binomial regression models compared groups on health care utilization. Both conditions significantly increased percentage of days housed, with no differences detected between conditions. In total, 74 (81.3%) AHCM and 64 (71.1%) HSG participants entered long-term housing (odds ratio = 1.9, 95% confidence interval [0.9, 4.0], p = .088). HSG participants experienced a greater decrease in emergency department visits than AHCM (p = .037), whereas AHCM participants remained in substance use treatment 52.7 days longer (p = .005) and had greater study treatment participation (p < .001) than HSG. ASI alcohol composite scores improved more for HSG than AHCM (p = .006), and both conditions improved on ASI drug and psychiatric scores and alcohol/drug abstinence. AHCM did not demonstrate overarching benefits beyond standard VA housing and substance use care. For those veterans not entering or losing long-term housing, different approaches to outreach and ongoing intervention are required. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Wine drinking and epithelial ovarian cancer risk: a meta-analysis

PubMed Central

Kim, Hee Seung; Shouten, Leo J.; Larsson, Susanna C.; Chung, Hyun Hoon; Kim, Yong Beom; Ju, Woong; Park, Noh Hyun; Song, Yong Sang; Kim, Seung Cheol; Kang, Soon-Beom

2010-01-01

Objective Wine has been the focus in the prevention of epithelial ovarian cancer (EOC) development because resveratrol abundant in wine has anti-carcinogenic properties. However, epidemiologic results have been heterogenous in the chemopreventive effect of wine on the development of EOC. Thus, we performed a meta-analysis for comparing EOC risk between wine and never drinkers using previous related studies. Methods After extensive search of the literature between January 1986 and December 2008, we analyzed 10 studies (3 cohort and 7 case control studies) with 135,871 women, who included 65,578 of wine and 70,293 of never drinkers. Results In all studies, there was no significant difference in EOC risk between wine and never drinkers (odds ratio [OR], 1.13; 95% confidence interval [CI], 0.92 to 1.38; random effects). When we performed re-analysis according to the study design, 3 cohort and 7 case control studies showed that there were also no significant differences in EOC risk between wine and never drinkers, respectively (OR, 1.44 and 1.04; 95% CI, 0.74 and 2.82 and 0.88 to 1.22; random effects). In sub-analyses using 2 case-control studies, EOC risk was not different between former and never drinkers (OR, 1.12; 95% CI, 0.87 to 1.44; fixed effect), and between current and former drinkers (OR, 0.74; 95% CI, 0.41 to 1.34; random effects). Conclusion Although resveratrol, abundantly found in wine, is a promising naturally occurring compound with chemopreventive properties on EOC in preclinical studies, this meta-analysis suggests the epidemiologic evidence shows no association between wine drinking and EOC risk. PMID:20613902

Descriptive epidemiology of typhoid fever during an epidemic in Harare, Zimbabwe, 2012.

PubMed

Polonsky, Jonathan A; Martínez-Pino, Isabel; Nackers, Fabienne; Chonzi, Prosper; Manangazira, Portia; Van Herp, Michel; Maes, Peter; Porten, Klaudia; Luquero, Francisco J

2014-01-01

Typhoid fever remains a significant public health problem in developing countries. In October 2011, a typhoid fever epidemic was declared in Harare, Zimbabwe - the fourth enteric infection epidemic since 2008. To orient control activities, we described the epidemiology and spatiotemporal clustering of the epidemic in Dzivaresekwa and Kuwadzana, the two most affected suburbs of Harare. A typhoid fever case-patient register was analysed to describe the epidemic. To explore clustering, we constructed a dataset comprising GPS coordinates of case-patient residences and randomly sampled residential locations (spatial controls). The scale and significance of clustering was explored with Ripley K functions. Cluster locations were determined by a random labelling technique and confirmed using Kulldorff's spatial scan statistic. We analysed data from 2570 confirmed and suspected case-patients, and found significant spatiotemporal clustering of typhoid fever in two non-overlapping areas, which appeared to be linked to environmental sources. Peak relative risk was more than six times greater than in areas lying outside the cluster ranges. Clusters were identified in similar geographical ranges by both random labelling and Kulldorff's spatial scan statistic. The spatial scale at which typhoid fever clustered was highly localised, with significant clustering at distances up to 4.5 km and peak levels at approximately 3.5 km. The epicentre of infection transmission shifted from one cluster to the other during the course of the epidemic. This study demonstrated highly localised clustering of typhoid fever during an epidemic in an urban African setting, and highlights the importance of spatiotemporal analysis for making timely decisions about targetting prevention and control activities and reinforcing treatment during epidemics. This approach should be integrated into existing surveillance systems to facilitate early detection of epidemics and identify their spatial range.

Descriptive Epidemiology of Typhoid Fever during an Epidemic in Harare, Zimbabwe, 2012

PubMed Central

Polonsky, Jonathan A.; Martínez-Pino, Isabel; Nackers, Fabienne; Chonzi, Prosper; Manangazira, Portia; Van Herp, Michel; Maes, Peter; Porten, Klaudia; Luquero, Francisco J.

2014-01-01

Background Typhoid fever remains a significant public health problem in developing countries. In October 2011, a typhoid fever epidemic was declared in Harare, Zimbabwe - the fourth enteric infection epidemic since 2008. To orient control activities, we described the epidemiology and spatiotemporal clustering of the epidemic in Dzivaresekwa and Kuwadzana, the two most affected suburbs of Harare. Methods A typhoid fever case-patient register was analysed to describe the epidemic. To explore clustering, we constructed a dataset comprising GPS coordinates of case-patient residences and randomly sampled residential locations (spatial controls). The scale and significance of clustering was explored with Ripley K functions. Cluster locations were determined by a random labelling technique and confirmed using Kulldorff's spatial scan statistic. Principal Findings We analysed data from 2570 confirmed and suspected case-patients, and found significant spatiotemporal clustering of typhoid fever in two non-overlapping areas, which appeared to be linked to environmental sources. Peak relative risk was more than six times greater than in areas lying outside the cluster ranges. Clusters were identified in similar geographical ranges by both random labelling and Kulldorff's spatial scan statistic. The spatial scale at which typhoid fever clustered was highly localised, with significant clustering at distances up to 4.5 km and peak levels at approximately 3.5 km. The epicentre of infection transmission shifted from one cluster to the other during the course of the epidemic. Conclusions This study demonstrated highly localised clustering of typhoid fever during an epidemic in an urban African setting, and highlights the importance of spatiotemporal analysis for making timely decisions about targetting prevention and control activities and reinforcing treatment during epidemics. This approach should be integrated into existing surveillance systems to facilitate early detection of epidemics and identify their spatial range. PMID:25486292

Inside the black box: starting to uncover the underlying decision rules used in one-by-one expert assessment of occupational exposure in case-control studies

PubMed Central

Wheeler, David C.; Burstyn, Igor; Vermeulen, Roel; Yu, Kai; Shortreed, Susan M.; Pronk, Anjoeka; Stewart, Patricia A.; Colt, Joanne S.; Baris, Dalsu; Karagas, Margaret R.; Schwenn, Molly; Johnson, Alison; Silverman, Debra T.; Friesen, Melissa C.

2014-01-01

Objectives Evaluating occupational exposures in population-based case-control studies often requires exposure assessors to review each study participants' reported occupational information job-by-job to derive exposure estimates. Although such assessments likely have underlying decision rules, they usually lack transparency, are time-consuming and have uncertain reliability and validity. We aimed to identify the underlying rules to enable documentation, review, and future use of these expert-based exposure decisions. Methods Classification and regression trees (CART, predictions from a single tree) and random forests (predictions from many trees) were used to identify the underlying rules from the questionnaire responses and an expert's exposure assignments for occupational diesel exhaust exposure for several metrics: binary exposure probability and ordinal exposure probability, intensity, and frequency. Data were split into training (n=10,488 jobs), testing (n=2,247), and validation (n=2,248) data sets. Results The CART and random forest models' predictions agreed with 92–94% of the expert's binary probability assignments. For ordinal probability, intensity, and frequency metrics, the two models extracted decision rules more successfully for unexposed and highly exposed jobs (86–90% and 57–85%, respectively) than for low or medium exposed jobs (7–71%). Conclusions CART and random forest models extracted decision rules and accurately predicted an expert's exposure decisions for the majority of jobs and identified questionnaire response patterns that would require further expert review if the rules were applied to other jobs in the same or different study. This approach makes the exposure assessment process in case-control studies more transparent and creates a mechanism to efficiently replicate exposure decisions in future studies. PMID:23155187

The effect of massage therapy on the quality of sleep in breast cancer patients.

PubMed

Kashani, Fahimeh; Kashani, Parisa

2014-03-01

Annually, about 6000 new cases are diagnosed with breast cancer in Iran. In Iran, more women are affected with breast cancer than a decade earlier in comparison with other countries, and 70% of them are diagnosed at an advanced phase. Insomnia is the most common disorder following breast cancer, and interference in sleep quality and rest causes changes in physiological functions and reduces the body's daily performance. The objective of this study was to determine the effect of massage therapy on the quality of sleep in patients with breast cancer. This clinical trial was conducted for about 1 month in a referral chemotherapy clinic of a teaching hospital in Isfahan, Iran. The participants consisted of 57 women with breast cancer who were selected by simple random sampling. They were randomly assigned to two groups of control and experimental. The control group was treated only by usual medical therapy, whereas the case group was treated by combined medical-massage therapy. Data collection tools were the validated Pittsburgh Sleep Quality Index and a demographic questionnaire. Data were analyzed by SPSS using descriptive statistics, Chi-square test, paired t-test, and Student's t-test. The results showed significant differences in the mean scores of quality of sleep before and after the intervention in the case group, while no significant differences were observed in the mean scores of quality of sleep before and after the intervention in the control group. In addition, no significant differences were observed in the mean scores of quality of sleep before the intervention between case and control groups. However, significant differences were observed in the mean scores of quality of sleep after the intervention between case and control groups. According to the results of this study, learning and applying massage techniques by medical staff causes health promotion and improves the quality of sleep in cancer patients. Furthermore, massage therapy is suggested as a non-pharmacologic method to improve sleep quality in these patients.

Chronic urinary tract infection and bladder carcinoma risk: a meta-analysis of case-control and cohort studies.

PubMed

Akhtar, Saeed; Al-Shammari, Ahmad; Al-Abkal, Jarrah

2018-02-05

This meta-analysis of published case-control and cohort studies sought to quantify the magnitude and direction of association between chronic UTI (defined as the infection of the urinary tract that either does not respond to treatment or keeps recurring) and risk of bladder carcinoma (BCa) (i.e., including mainly urothelial carcinoma, squamous cell carcinoma or adenocarcinoma). A literature search was conducted using Medline, Embase, Ovid, Web of Science, Science Direct and Cochrane Library, which was supplemented with manual search of reference lists of the identified articles. Case-control and cohort studies examining UTI as a predictor of BCa risk published through June 2016 were eligible. Using random-effects models, odds ratios (OR) or relative risks (RR) from eligible studies were combined to synthesize summary effect estimates. The included studies were assessed for methodological quality and potential publication bias. Heterogeneity by study characteristics was examined by sub-group and meta-regression analyses. Eighteen case-control and three cohort studies published between 1963 and 2016 were eligible. Random-effects models showed that UTI was significantly associated with an increased BCa risk both in case-control studies (summary OR RE  = 2.33; 95% CI 1.86, 2.92) and cohort studies (summary RR RE  = 2.88; 95% CI 1.20, 6.89). The observed relationship of UTI with an increased BCa risk was independent of the study characteristics considered. No significant publication bias was detected. Chronic UTI was significantly and independently associated with an increased BCa risk. However, due to the presence of high between-study heterogeneity and inconsistent patterns of adjusted confounding effects, more data are needed to clarify the role of chronic UTI in causation of BCa and if established, prompt and effective treatment of UTI may minimize a substantial proportion of BCa risk.

[Acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment: a randomized controlled trial].

PubMed

Li, Yi; Liu, Xue-bing; Zhang, Yao

2012-08-01

To study the efficacy and safety of acupuncture therapy for the improvement of sleep quality of outpatients receiving methadone maintenance treatment (MMT). Using randomized double-blinded controlled design, seventy-five MMT outpatients with low sleep quality [score of Pittsburgh sleep quality index (PSQI) > or = 8], were randomly assigned to the acupuncture group (38 cases) and the sham-acupuncture group (37 cases). All patients maintained previous MMT. Acupuncture was applied to Baihui (GV20), Shenmen (bilateral, TF4), Shenting (GV24), Sanyinjiao (bilateral, SP6), and Sishencong (EX-HN1) in the acupuncture group. The same procedures were performed in the sham-acupuncture group, but not to the acupoints (5 mm lateral to the acupoints selected in the acupuncture group) with shallow needling technique. The treatment was performed 5 times each week for 8 successive weeks. The PSQI was assessed before treatment, at the end of the 2nd, 4th, 6th, and 8th week of the treatment. The detection ratio of low sleep quality and the incidence of adverse acupuncture reactions were compared between the two groups at the end of the 8th week. The overall PSQI score was obviously higher in the acupuncture group than in the sham-acupuncture group with statistical difference (P < 0.01). The detection ratio of low sleep quality at the end of the 8th week was lower in the acupuncture group (60.53%, 23/38 cases) than in the sham-acupuncture group (83.78%, 31/37 cases) with statistical difference (P < 0.05). The rate of adverse acupuncture reaction was 5.26% (2/38 cases) in the acupuncture group and 2.70% (1/37 cases) in the sham-acupuncture group respectively, showing no statistical difference (P > 0.05). Acupuncture therapy could effectively and safely improve the sleep quality of outpatients receiving MMT.

Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial.

PubMed

Wadhwa, Nitya; Basnet, Sudha; Natchu, Uma Chandra Mouli; Shrestha, Laxman P; Bhatnagar, Shinjini; Sommerfelt, Halvor; Strand, Tor A; Ramji, Siddarth; Aggarwal, K C; Chellani, Harish; Govil, Anuradha; Jajoo, Mamta; Mathur, N B; Bhatt, Meenakshi; Mohta, Anup; Ansari, Imran; Basnet, Srijana; Chapagain, Ram H; Shah, Ganesh P; Shrestha, Binod M

2017-07-10

An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.

The potential value of sibling controls compared with population controls for association studies of lifestyle-related risk factors: an example from the Breast Cancer Family Registry.

PubMed

Milne, Roger L; John, Esther M; Knight, Julia A; Dite, Gillian S; Southey, Melissa C; Giles, Graham G; Apicella, Carmel; West, Dee W; Andrulis, Irene L; Whittemore, Alice S; Hopper, John L

2011-10-01

A previous Australian population-based breast cancer case-control study found indirect evidence that control participation, although high, was not random. We hypothesized that unaffected sisters may provide a more appropriate comparison group than unrelated population controls. Three population-based case-control-family studies of breast cancer in women of white European origin were carried out by the Australian, Ontario and Northern California sites of the Breast Cancer Family Registry. We compared risk factors between 3643 cases, 2444 of their unaffected sisters and 2877 population controls and conducted separate case-control analyses based on population and sister controls using unconditional multivariable logistic regression. Compared with sister controls, population controls were more highly educated, had an earlier age at menarche, fewer births, their first birth at a later age and their last birth more recently. The established breast cancer associations detected using sister controls, but not detected using population controls, were decreasing risk with each of later age at menarche, more births, younger age at first birth and greater time since last birth. Since participation of population controls might be unintentionally related to some risk factors, we hypothesize that sister controls could provide more valid relative risk estimates and be recruited at lower cost. Given declining study participation by population controls, this contention is highly relevant to epidemiologic research.

Are results of randomized controlled trials useful to psychotherapists?

PubMed

Persons, J B; Silberschatz, G

1998-02-01

Two clinicians provided opposite answers to the title question: Persons argued that information from randomized controlled trials (RCTs) is vital to clinicians, and Silberschatz argued that information from RCTs is irrelevant to clinicians. Persons argued that clinicians cannot provide top quality care to their patients without attending to findings of RCTs and that clinicians have an ethical responsibility to inform patients about, recommend, and provide treatments supported by RCTs before informing patients about, recommending, and providing treatments shown to be inferior in RCTs or not evaluated in RCTs. Silberschatz argued that RCTs do not and cannot answer questions that concern practicing clinicians. He advocates alternative research approaches (effectiveness studies, quasi-experimental methods, case-specific research) for studying psychotherapy.

Village doctor-assisted case management of rural patients with schizophrenia: protocol for a cluster randomized control trial.

PubMed

Gong, Wenjie; Xu, Dong; Zhou, Liang; Brown, Henry Shelton; Smith, Kirk L; Xiao, Shuiyuan

2014-01-16

Strict compliance with prescribed medication is the key to reducing relapses in schizophrenia. As villagers in China lack regular access to psychiatrists to supervise compliance, we propose to train village 'doctors' (i.e., villagers with basic medical training and currently operating in villages across China delivering basic clinical and preventive care) to manage rural patients with schizophrenia with respect to compliance and monitoring symptoms. We hypothesize that with the necessary training and proper oversight, village doctors can significantly improve drug compliance of villagers with schizophrenia. We will conduct a cluster randomized controlled trial in 40 villages in Liuyang, Hunan Province, China, home to approximately 400 patients with schizophrenia. Half of the villages will be randomized into the treatment group (village doctor, or VD model) wherein village doctors who have received training in a schizophrenia case management protocol will manage case records, supervise drug taking, educate patients and families on schizophrenia and its treatment, and monitor patients for signs of relapse in order to arrange prompt referral. The other 20 villages will be assigned to the control group (case as usual, or CAU model) wherein patients will be visited by psychiatrists every two months and receive free antipsychotic medications under an on-going government program, Project 686. These control patients will receive no other management or follow up from health workers. A baseline survey will be conducted before the intervention to gather data on patient's socio-economic status, drug compliance history, and clinical and health outcome measures. Data will be re-collected 6 and 12 months into the intervention. A difference-in-difference regression model will be used to detect the program effect on drug compliance and other outcome measures. A cost-effectiveness analysis will also be conducted to compare the value of the VD model to that of the CAU group. Lack of specialists is a common problem in resource-scarce areas in China and other developing countries. The results of this experiment will provide high level evidence on the role of health workers with relatively limited medical training in managing severe psychiatric disease and other chronic conditions in developing countries. ChiCTR-TRC-13003263.

Recurrence of tuberculosis among patients following treatment completion in eight provinces of Vietnam: a nested case-control study.

PubMed

Bestrashniy, Jessica Rutledge Bruce Musselman; Nguyen, Viet Nhung; Nguyen, Thi Loi; Pham, Thi Lieu; Nguyen, Thu Anh; Pham, Duc Cuong; Nghiem, Le Phuong Hoa; Le, Thi Ngoc Anh; Nguyen, Binh Hoa; Nguyen, Kim Cuong; Nguyen, Huy Dung; Buu, Tran Ngoc; Le, Thi Nhung; Nguyen, Viet Hung; Dinh, Ngoc Sy; Britton, Warwick John; Marks, Guy Barrington; Fox, Greg James

2018-06-23

Patients completing treatment for tuberculosis (TB) in high-prevalence settings face a risk of developing recurrent disease. This has important consequences for public health, given its association with drug resistance and a poor prognosis. Previous research has implicated individual factors such as smoking, alcohol use, HIV, poor treatment adherence, and drug resistant disease as risk factors for recurrence. However, little is known about how these factors co-act to produce recurrent disease. Furthermore, perhaps factors related to the index disease means higher burden/low resource settings may be more prone to recurrent disease that could be preventable. We conducted a case-control study nested within a cohort of consecutively enrolled adults who were being treated for smear positive pulmonary TB in 70 randomly selected district clinics in Vietnam. Cases were patients with recurrent TB, identified by follow-up from the parent cohort study. Controls were selected from the cohort by random sampling. Information on demographic, clinical and disease-related characteristics was obtained by interview. information was extracted from clinic registries. Logistic regression, with stepwise selection, was used to develop a fully adjusted model for the odds of recurrence of TB. We recruited 10,964 patients between October 2010 and July 2013. Median follow-up was 988 days. At the end of follow-up, 505 patients (4.7%) with recurrence were identified as cases and 630 other patients were randomly selected as controls. Predictors of recurrence included multidrug-resistant (MDR)-TB (adjusted odds ratio 79.6; 95% CI: 25.1-252.0), self-reported prior TB therapy (aOR=2.5; 95% CI: 1.7-3.5), and incomplete adherence (aOR=1.9; 95% CI 1.1-3.1). Index disease treatment history is a leading determinant of relapse among patients with TB in Vietnam. Further research is required to identify interventions that will reduce the risk of recurrent disease and enhance its early detection within high-risk populations. Copyright © 2018. Published by Elsevier Ltd.

A randomized controlled trial of the effects of hypnosis with 3-D virtual reality animation on tiredness, mood, and salivary cortisol.

PubMed

Thompson, Trevor; Steffert, Tony; Steed, Anthony; Gruzelier, John

2011-01-01

Case studies suggest hypnosis with a virtual reality (VR) component may be an effective intervention; although few follow-up randomized, controlled trials have been performed comparing such interventions with standard hypnotic treatments. Thirty-five healthy participants were randomized to self-hypnosis with VR imagery, standard self-hypnosis, or relaxation interventions. Changes in sleep, cortisol levels, and mood were examined. Self-hypnosis involved 10- to 20-min. sessions visualizing a healthy immune scenario. Trait absorption was also recorded as a possible moderator. Moderated regression indicated that both hypnosis interventions produced significantly lower tiredness ratings than relaxation when trait absorption was high. When trait absorption was low, VR resulted in significantly higher engagement ratings, although this did not translate to demonstrable improvement in outcome. Results suggest that VR imagery may increase engagement relative to traditional methods, but further investigation into its potential to enhance therapeutic efficacy is required.

Household costs of dengue illness: secondary outcomes from a randomised controlled trial of dengue prevention in Guerrero state, Mexico.

PubMed

Legorreta-Soberanis, José; Paredes-Solís, Sergio; Morales-Pérez, Arcadio; Nava-Aguilera, Elizabeth; Serrano-de Los Santos, Felipe René; Dimas-Garcia, Diana Lisseth; Ledogar, Robert J; Cockcroft, Anne; Andersson, Neil

2017-05-30

Dengue is a serious public health problem with an important economic impact. This study used data from a cluster randomised controlled trial of community mobilisation for dengue prevention to estimate the household costs of treatment of dengue illness. It examined the economic impact of the trial intervention in the three coastal regions of Mexico's Guerrero State. The 2010 baseline survey covered households in a random sample of 90 clusters in the coastal regions; the clusters were randomly allocated to intervention or control and re-surveyed in 2012. The surveys asked about dengue cases in the last 12 months, expenditures on their treatment, and work or school days lost by patients and care givers. We did not assign monetary value to days lost, since a lost day to a person of low earning power is of equal or higher value to that person than to one who earns more. The 12,312 households in 2010 reported 1020 dengue cases in the last 12 months (1.9% of the sample population). Most (78%) were ambulatory cases, with a mean cost of USD 51 and 10.8 work/school days, rising to USD 96 and 11.4 work/school days if treated by a private physician. Hospitalised cases cost USD 28-94 in government institutions and USD 392 in private hospitals (excluding additional inpatient charges), as well as 9.6-17.3 work/school days. Dengue cases cost households an estimated 412,825 work/school days throughout the three coastal regions. In the follow up survey, 6.1% (326/5349) of households in intervention clusters and 7.9% (405/5139) in control clusters reported at least one dengue case. The mean of days lost per case was similar in intervention and control clusters, but the number of days lost from dengue and all elements of costs for dengue cases per 1000 population were lower in intervention clusters. If the total population of the three coastal regions had received the intervention, some 149,401 work or school days lost per year could have been prevented. The economic effect of dengue on households, including lost work days, is substantial. The Camino Verde trial intervention reduced household costs for treatment of dengue cases. The trial was registered as ISRCTN:27,581,154 .

Prevalence of Post-tonsillectomy Bleeding as Day-case Surgery with Combination Method; Cold Dissection Tonsillectomy and Bipolar Diathermy Hemostasis

PubMed Central

Faramarzi, Abolahassan; Heydari, Seyed Taghi

2010-01-01

Objective Post-tonsillectomy hemorrhage remains an important factor in determining the safety of performing tonsillectomy as a day case procedure. The aim of this study was to determine the safety of day case tonsillectomy by using combination method, cold dissection tonsillectomy and bipolar diathermy hemostasis. Methods A prospective randomized clinical study conducted on the patients who had undergone day case tonsillectomy (DCT). There were two groups (DCT and control group) each group consisting of 150 cases. Tonsillectomy was performed by using combination method; cold dissection and hemostasis was achieved by ligation of vessels with bipolar electerocautery. Findings We found 3 cases of post-tonsillectomy bleeding in DCT group and 4 cases in the control group. There was no statistically significant difference in the rate of post-operative hemorrhage between the two groups. Conclusion The findings suggest the safety of the combination of cold dissection tonsillectomy and bipolar diathermy hemostasis as day case tonsillectomy. PMID:23056702

Progressive Muscle Relaxation Combined with Chinese Medicine Five-Element Music on Depression for Cancer Patients: A Randomized Controlled Trial.

PubMed

Liao, Juan; Wu, Yu; Zhao, Yang; Zhao, Yuan-Chen; Zhang, Xu; Zhao, Nan; Lee, Chun-Ging; Yang, Yu-Fei

2018-05-01

To evaluate the effects of progressive muscle relaxation training (PMRT) combined with fifive elements music therapy of Chinese medicine (CM) for improving anxiety and depression of cancer patients. From June 2015 to March 2016, 60 cancer patients were included into the study. The patients were randomly assigned to a control group and a treatment group by envelope randomization, receiving PMRT and PMRT plus CM five elements music therapy, respectively, for 8 weeks. Hospital Anxiety and Depression Scale (HADS), Benefit Finding Scales (BFS), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), and Intervention Expectations Questionnaire (IEQU) were adopted to assess the depression of the two groups before and after the treatment. Four cases dropped out during the study, and 29 cases in the treatment group and 27 in the control group were included in the fifinal analysis. Prior to the treatments, the baselines of the 4 questionnaires in the two groups showed no difference. After the 8-week treatment, the treatment group presented better levels of HADS, BFS and FACIT-Sp scores compared with the control group (P<0.05). Among the single items of HADS, 4 items involving vexation, feeling fifidgeted, pleasure and prospecting the future in the treatment group were improved compared with the control group (P<0.05). As a simple and reliable and effective intervention, PMRT combined with fifive elements music therapy mitigated anxiety and depression of cancer patients. Cancer patients have been found to respond well to psychological intervention in areas regarding stabilisation of emotions, disease awareness, and therapeutic compliance. This brings about a great difference in improving their quality of life and psychological state, offers an effective approach to better self-management in cancer treatment.

Mixed Model Association with Family-Biased Case-Control Ascertainment.

PubMed

Hayeck, Tristan J; Loh, Po-Ru; Pollack, Samuela; Gusev, Alexander; Patterson, Nick; Zaitlen, Noah A; Price, Alkes L

2017-01-05

Mixed models have become the tool of choice for genetic association studies; however, standard mixed model methods may be poorly calibrated or underpowered under family sampling bias and/or case-control ascertainment. Previously, we introduced a liability threshold-based mixed model association statistic (LTMLM) to address case-control ascertainment in unrelated samples. Here, we consider family-biased case-control ascertainment, where case and control subjects are ascertained non-randomly with respect to family relatedness. Previous work has shown that this type of ascertainment can severely bias heritability estimates; we show here that it also impacts mixed model association statistics. We introduce a family-based association statistic (LT-Fam) that is robust to this problem. Similar to LTMLM, LT-Fam is computed from posterior mean liabilities (PML) under a liability threshold model; however, LT-Fam uses published narrow-sense heritability estimates to avoid the problem of biased heritability estimation, enabling correct calibration. In simulations with family-biased case-control ascertainment, LT-Fam was correctly calibrated (average χ 2 = 1.00-1.02 for null SNPs), whereas the Armitage trend test (ATT), standard mixed model association (MLM), and case-control retrospective association test (CARAT) were mis-calibrated (e.g., average χ 2 = 0.50-1.22 for MLM, 0.89-2.65 for CARAT). LT-Fam also attained higher power than other methods in some settings. In 1,259 type 2 diabetes-affected case subjects and 5,765 control subjects from the CARe cohort, downsampled to induce family-biased ascertainment, LT-Fam was correctly calibrated whereas ATT, MLM, and CARAT were again mis-calibrated. Our results highlight the importance of modeling family sampling bias in case-control datasets with related samples. Copyright © 2017 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Biomarkers and bacterial pneumonia risk in patients with treated HIV infection: a case-control study.

PubMed

Bjerk, Sonja M; Baker, Jason V; Emery, Sean; Neuhaus, Jacqueline; Angus, Brian; Gordin, Fred M; Pett, Sarah L; Stephan, Christoph; Kunisaki, Ken M

2013-01-01

Despite advances in HIV treatment, bacterial pneumonia continues to cause considerable morbidity and mortality in patients with HIV infection. Studies of biomarker associations with bacterial pneumonia risk in treated HIV-infected patients do not currently exist. We performed a nested, matched, case-control study among participants randomized to continuous combination antiretroviral therapy (cART) in the Strategies for Management of Antiretroviral Therapy trial. Patients who developed bacterial pneumonia (cases) and patients without bacterial pneumonia (controls) were matched 1∶1 on clinical center, smoking status, age, and baseline cART use. Baseline levels of Club Cell Secretory Protein 16 (CC16), Surfactant Protein D (SP-D), C-reactive protein (hsCRP), interleukin-6 (IL-6), and d-dimer were compared between cases and controls. Cases (n = 72) and controls (n = 72) were 25.7% female, 51.4% black, 65.3% current smokers, 9.7% diabetic, 36.1% co-infected with Hepatitis B/C, and 75.0% were on cART at baseline. Median (IQR) age was 45 (41, 51) years with CD4+ count of 553 (436, 690) cells/mm(3). Baseline CC16 and SP-D were similar between cases and controls, but hsCRP was significantly higher in cases than controls (2.94 µg/mL in cases vs. 1.93 µg/mL in controls; p = 0.02). IL-6 and d-dimer levels were also higher in cases compared to controls, though differences were not statistically significant (p-value 0.06 and 0.10, respectively). In patients with cART-treated HIV infection, higher levels of systemic inflammatory markers were associated with increased bacterial pneumonia risk, while two pulmonary-specific inflammatory biomarkers, CC16 and SP-D, were not associated with bacterial pneumonia risk.

Noncultured keratinocyte/melanocyte cosuspension: effect on reepithelialization and repigmentation--a randomized, placebo-controlled study.

PubMed

Back, Christopher; Dearman, Bronwyn; Li, Amy; Neild, Tim; Greenwood, John E

2009-01-01

Randomized controlled trials in the literature investigating the efficacy of noncultured keratinocyte/melanocyte suspensions are scarce; however, the advocates of such techniques press the value of their application based largely on case studies and anecdote. Caucasian patients with burn hypopigmentation seldom request cosmetic revision making worthwhile clinical trials difficult so that informal case treatments with new therapies generate anecdotal results. A randomized, placebo-controlled trial was carried out to evaluate whether cosuspensions of noncultured skin cells are capable of (1) decreasing the time to reepithelialization and (2) reestablishing pigmentation in vitiligo leukoderma following epidermal/superficial dermal ablation (in the knowledge that a positive result would make the technique likely to be successful in burn hypopigmentation). Vitiligo is common and is socially more debilitating such that suitable trial subjects for new therapies from this pool are more forthcoming. This study demonstrated that suspensions of noncultured keratinocytes and melanocytes do not decrease the time to epithelialization of superficial partial thickness wounds compared with controls. It also suggested that the achievement, quality, and duration of any pigmentation were unpredictable and largely disappointing. Some pigmentation was recorded in placebo-treated areas indicating an effect of the method of epidermal ablation in these patients. These findings have mandated a complete review of the use of these techniques in burn care at the Royal Adelaide Hospital; they have been omitted from surgical protocols where the aim of use was to speed reepithelialization. Their infrequent use in burns hypopigmentation will continue contingent on the successful repigmentation of a test patch.

Hyperbaric oxygen therapy in the treatment of osteonecrosis of the femoral head: a review of the current literature.

PubMed

Uzun, Gunalp; Mutluoglu, Mesut; Ersen, Omer; Yildiz, Senol

2016-01-01

To review the current literature on the use of hyperbaric oxygen (HBO₂) therapy in the treatment of osteonecrosis of the femoral head (ONFH). We searched PubMed, Directory of Open Access Journals (DOAJ), EMBASE, Web of Science, Academic Search Complete, CINAHL and MEDLINE through April 2015. We hand-searched relevant textbooks, conference proceedings and the reference lists of review articles and clinical studies Randomized controlled trials (RCT) and observational studies (cohort study, case-control study, case series) that reported the outcome of patients who received HBO₂therapy for ONFH were included. Only English-language articles were included. Study quality was not used as an exclusion criterion. Two authors independently assessed trials for inclusion, extracted data and presented to other authors. Disagreements were resolved by consensus. We identified eight clinical studies; two randomized controlled trials (RCTs); one historically controlled study; and five case series. The majority of the studies were small-scale, heterogeneous and methodologically weak. In four of the studies HBO₂therapy was combined with other treatment modalities, making it impossible to draw firm conclusions on the specific effects of HBO₂therapy. Hip survivorship in studies wherein HBO₂therapy was used alone was 95.5% in Steinberg Stage I lesions, 89% in Steinberg Stage II lesions and 100% in Ficat Stage II lesions. There is a room for HBO₂therapy in the management ONFH. Further RCTs, however, are required to better elucidate the role of HBO₂therapy in the treatment of ONFH.

Itopride therapy for functional dyspepsia: A meta-analysis

PubMed Central

Huang, Xuan; Lv, Bin; Zhang, Shuo; Fan, Yi-Hong; Meng, Li-Na

2012-01-01

AIM: To evaluate the therapeutic effects of itopride vs other drugs (placebo, domperidone, mosapride) for functional dyspepsia (FD). METHODS: Randomized controlled trials (RCTs) of itopride for FD were retrieved from databases. Relevant information was extracted and analyzed, using the relative risk (RR) and weighted mean deviation, as appropriate. A random or fixed effect model was used, based on the heterogeneity of the included articles, and visual inspection of funnel plots was used to evaluate publication bias. RESULTS: Nine RCTs enrolling 2620 FD cases were included; 1372 cases received itopride treatment and 1248 cases received placebo or other drugs (control groups). Compared with control groups, itopride had superior RR values of 1.11 [95%CI: (1.03, 1.19), P = 0.006], 1.21 [95%CI: (1.03, 1.44), P = 0.02], and 1.24 [95%CI: (1.01, 1.53), P = 0.04] for global patient assessment, postprandial fullness, and early satiety, respectively. For the Leeds Dyspepsia Questionnaire score, the weighted mean deviation was -1.38 [95%CI: (-1.75, -1.01), P < 0.01]. The incidence of adverse effects was similar in the itopride and control groups. The funnel plots for all indicators showed no evidence of publication bias. CONCLUSION: Itopride has good efficacy in terms of global patients assessment, postprandial fullness, and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions. Itopride can greatly improve FD syndromes-score. PMID:23326147

Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial.

PubMed

Ali, Mohammad; Debes, Amanda K; Luquero, Francisco J; Kim, Deok Ryun; Park, Je Yeon; Digilio, Laura; Manna, Byomkesh; Kanungo, Suman; Dutta, Shanta; Sur, Dipika; Bhattacharya, Sujit K; Sack, David A

2016-09-01

Vaccinating a buffer of individuals around a case (ring vaccination) has the potential to target those who are at highest risk of infection, reducing the number of doses needed to control a disease. We explored the potential vaccine effectiveness (VE) of oral cholera vaccines (OCVs) for such a strategy. This analysis uses existing data from a cluster-randomized clinical trial in which OCV or placebo was given to 71,900 participants in Kolkata, India, from 27 July to 10 September 2006. Cholera surveillance was then conducted on 144,106 individuals living in the study area, including trial participants, for 5 y following vaccination. First, we explored the risk of cholera among contacts of cholera patients, and, second, we measured VE among individuals living within 25 m of cholera cases between 8 and 28 d after onset of the index case. For the first analysis, individuals living around each index case identified during the 5-y period were assembled using a ring to define cohorts of individuals exposed to cholera index cases. An index control without cholera was randomly selected for each index case from the same population, matched by age group, and individuals living around each index control were assembled using a ring to define cohorts not exposed to cholera cases. Cholera attack rates among the exposed and non-exposed cohorts were compared using different distances from the index case/control to define the rings and different time frames to define the period at risk. For the VE analysis, the exposed cohorts were further stratified according to the level of vaccine coverage into high and low coverage strata. Overall VE was assessed by comparing the attack rates between high and low vaccine coverage strata irrespective of individuals' vaccination status, and indirect VE was assessed by comparing the attack rates among unvaccinated members between high and low vaccine coverage strata. Cholera risk among the cohort exposed to cholera cases was 5-11 times higher than that among the cohort not exposed to cholera cases. The risk gradually diminished with an increase in distance and time. The overall and indirect VE measured between 8 and 28 d after exposure to a cholera index case during the first 2 y was 91% (95% CI 62%-98%) and 93% (95% CI 44%-99%), respectively. VE persisted for 5 y after vaccination and was similar whether the index case was a young child (<5 y) or was older. Of note, this study was a reanalysis of a cholera vaccine trial that used two doses; thus, a limitation of the study relates to the assumption that a single dose, if administered quickly, will induce a similar level of total and indirect protection over the short term as did two doses. These findings suggest that high-level protection can be achieved if individuals living close to cholera cases are living in a high coverage ring. Since this was an observational study including participants who had received two doses of vaccine (or placebo) in the clinical trial, further studies are needed to determine whether a ring vaccination strategy, in which vaccine is given quickly to those living close to a case, is feasible and effective. ClinicalTrials.gov NCT00289224.

Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial

PubMed Central

Ali, Mohammad; Luquero, Francisco J.; Kim, Deok Ryun; Park, Je Yeon; Digilio, Laura; Manna, Byomkesh; Kanungo, Suman; Dutta, Shanta; Sur, Dipika; Bhattacharya, Sujit K.

2016-01-01

Introduction Vaccinating a buffer of individuals around a case (ring vaccination) has the potential to target those who are at highest risk of infection, reducing the number of doses needed to control a disease. We explored the potential vaccine effectiveness (VE) of oral cholera vaccines (OCVs) for such a strategy. Methods and Findings This analysis uses existing data from a cluster-randomized clinical trial in which OCV or placebo was given to 71,900 participants in Kolkata, India, from 27 July to 10 September 2006. Cholera surveillance was then conducted on 144,106 individuals living in the study area, including trial participants, for 5 y following vaccination. First, we explored the risk of cholera among contacts of cholera patients, and, second, we measured VE among individuals living within 25 m of cholera cases between 8 and 28 d after onset of the index case. For the first analysis, individuals living around each index case identified during the 5-y period were assembled using a ring to define cohorts of individuals exposed to cholera index cases. An index control without cholera was randomly selected for each index case from the same population, matched by age group, and individuals living around each index control were assembled using a ring to define cohorts not exposed to cholera cases. Cholera attack rates among the exposed and non-exposed cohorts were compared using different distances from the index case/control to define the rings and different time frames to define the period at risk. For the VE analysis, the exposed cohorts were further stratified according to the level of vaccine coverage into high and low coverage strata. Overall VE was assessed by comparing the attack rates between high and low vaccine coverage strata irrespective of individuals’ vaccination status, and indirect VE was assessed by comparing the attack rates among unvaccinated members between high and low vaccine coverage strata. Cholera risk among the cohort exposed to cholera cases was 5–11 times higher than that among the cohort not exposed to cholera cases. The risk gradually diminished with an increase in distance and time. The overall and indirect VE measured between 8 and 28 d after exposure to a cholera index case during the first 2 y was 91% (95% CI 62%–98%) and 93% (95% CI 44%–99%), respectively. VE persisted for 5 y after vaccination and was similar whether the index case was a young child (<5 y) or was older. Of note, this study was a reanalysis of a cholera vaccine trial that used two doses; thus, a limitation of the study relates to the assumption that a single dose, if administered quickly, will induce a similar level of total and indirect protection over the short term as did two doses. Conclusions These findings suggest that high-level protection can be achieved if individuals living close to cholera cases are living in a high coverage ring. Since this was an observational study including participants who had received two doses of vaccine (or placebo) in the clinical trial, further studies are needed to determine whether a ring vaccination strategy, in which vaccine is given quickly to those living close to a case, is feasible and effective. Trial registration ClinicalTrials.gov NCT00289224 PMID:27622507

Clinical Application of Mesenchymal Stem Cells and Novel Supportive Therapies for Oral Bone Regeneration

PubMed Central

O'Valle, Francisco; Lanis, Alejandro; Dohan Ehrenfest, David M.; Wang, Hom-Lay; Galindo-Moreno, Pablo

2015-01-01

Bone regeneration is often needed prior to dental implant treatment due to the lack of adequate quantity and quality of the bone after infectious diseases, trauma, tumor, or congenital conditions. In these situations, cell transplantation technologies may help to overcome the limitations of autografts, xenografts, allografts, and alloplastic materials. A database search was conducted to include human clinical trials (randomized or controlled) and case reports/series describing the clinical use of mesenchymal stem cells (MSCs) in the oral cavity for bone regeneration only specifically excluding periodontal regeneration. Additionally, novel advances in related technologies are also described. 190 records were identified. 51 articles were selected for full-text assessment, and only 28 met the inclusion criteria: 9 case series, 10 case reports, and 9 randomized controlled clinical trials. Collectively, they evaluate the use of MSCs in a total of 290 patients in 342 interventions. The current published literature is very diverse in methodology and measurement of outcomes. Moreover, the clinical significance is limited. Therefore, the use of these techniques should be further studied in more challenging clinical scenarios with well-designed and standardized RCTs, potentially in combination with new scaffolding techniques and bioactive molecules to improve the final outcomes. PMID:26064899

Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal.

PubMed

Yayla Abide, Cigdem; Ozkaya, Enis; Sanverdi, Ilhan; Bostancı Ergen, Evrim; Kurek Eken, Meryem; Devranoglu, Belgin; Bilgiç, Bulent Emre; Kilicci, Cetin; Kayatas Eser, Semra

2018-05-14

To compare embryo transfer (ET) technique based on catheter rotation during its withdrawal in cases with unexplained infertility in a prospective, randomized trial (NCT03097042). Two hundred intracytoplasmic sperm injection (ICSI) patients undergoing ET with cleaving or blastocyst-stage fresh embryos were randomized into 2 groups: cases with (n = 100), and without (n = 100) catheter rotation during its withdrawal. Groups were matched for age and some clinical parameters. A soft catheter was used to transfer a single embryo with catheter rotation during its withdrawal in the study group and without rotation in the control. The use of a stiff catheter or tenaculum was not needed in any case. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. Pregnancy rate was significantly higher in the study group (41 vs. 26%, p = 0.04). Clinical pregnancy rate was also significantly higher in the study group (39 vs. 25%, OR 1.9 [1.1-3.5], p = 0.05). On the other hand, the ongoing pregnancy rate was similar between the 2 groups (33 vs. 23%, p = 0.2). Catheter rotation during its withdrawal may be associated with increased pregnancy and clinical pregnancy rates; however, the difference in ongoing pregnancy rates did not reach statistical significance. © 2018 S. Karger AG, Basel.

Recall bias in the assessment of exposure to mobile phones.

PubMed

Vrijheid, Martine; Armstrong, Bruce K; Bédard, Daniel; Brown, Julianne; Deltour, Isabelle; Iavarone, Ivano; Krewski, Daniel; Lagorio, Susanna; Moore, Stephen; Richardson, Lesley; Giles, Graham G; McBride, Mary; Parent, Marie-Elise; Siemiatycki, Jack; Cardis, Elisabeth

2009-05-01

Most studies of mobile phone use are case-control studies that rely on participants' reports of past phone use for their exposure assessment. Differential errors in recalled phone use are a major concern in such studies. INTERPHONE, a multinational case-control study of brain tumour risk and mobile phone use, included validation studies to quantify such errors and evaluate the potential for recall bias. Mobile phone records of 212 cases and 296 controls were collected from network operators in three INTERPHONE countries over an average of 2 years, and compared with mobile phone use reported at interview. The ratio of reported to recorded phone use was analysed as measure of agreement. Mean ratios were virtually the same for cases and controls: both underestimated number of calls by a factor of 0.81 and overestimated call duration by a factor of 1.4. For cases, but not controls, ratios increased with increasing time before the interview; however, these trends were based on few subjects with long-term data. Ratios increased by level of use. Random recall errors were large. In conclusion, there was little evidence for differential recall errors overall or in recent time periods. However, apparent overestimation by cases in more distant time periods could cause positive bias in estimates of disease risk associated with mobile phone use.

Outbreak of Salmonella Enteritidis phage type 13a: case-control investigation in Hertsmere, United Kingdom.

PubMed

Morgan, O; Milne, L; Kumar, S; Murray, D; Man, W; Georgiou, M; Verlander, N Q; de Pinna, E; McEvoy, M

2007-07-01

Cases of illness were reported to Hertsmere Borough Council among attendees of a children's charity event in June 2006. Initial laboratory investigation identified Salmonella Enteritidis PT13a as a possible cause of the outbreak. We carried out an unmatched case-control investigation. The population at risk included all individuals who attended the event. Self-completion questionnaires were sent to 53 presumptive cases and 212 randomly selected potential controls. Information was available for 49 cases and 128 controls (overall response rate=75%). We calculated odds ratios from single and multivariable analysis and tested for all two-way interactions. Risk factors for diarrhoea were eating egg mayonnaise bagels (OR=34.1, 95%CI 10.5 - 111.3) and drinking apple juice (OR=16.1, 95% CI 3.5 - 74.2). There was weak statistical evidence to suggest that the risk of diarrhoea after eating egg mayonnaise bagels was greater in the afternoon. No food samples were available to confirm which food item might have caused this outbreak. Eggs from Spain were used by the caterer. The ecology of salmonella, experience from previous outbreaks and epidemiological findings from this case-control investigation suggest that the most likely cause of the outbreak was contaminated eggs.

Active Control of the Forced and Transient Response of a Finite Beam. M.S. Thesis

NASA Technical Reports Server (NTRS)

Post, John Theodore

1989-01-01

When studying structural vibrations resulting from a concentrated source, many structures may be modelled as a finite beam excited by a point source. The theoretical limit on cancelling the resulting beam vibrations by utilizing another point source as an active controller is explored. Three different types of excitation are considered, harmonic, random, and transient. In each case, a cost function is defined and minimized for numerous parameter variations. For the case of harmonic excitation, the cost function is obtained by integrating the mean squared displacement over a region of the beam in which control is desired. A controller is then found to minimize this cost function in the control interval. The control interval and controller location are continuously varied for several frequencies of excitation. The results show that control over the entire beam length is possible only when the excitation frequency is near a resonant frequency of the beam, but control over a subregion may be obtained even between resonant frequencies at the cost of increasing the vibration outside of the control region. For random excitation, the cost function is realized by integrating the expected value of the displacement squared over the interval of the beam in which control is desired. This is shown to yield the identical cost function as obtained by integrating the cost function for harmonic excitation over all excitation frequencies. As a result, it is always possible to reduce the cost function for random excitation whether controlling the entire beam or just a subregion, without ever increasing the vibration outside the region in which control is desired. The last type of excitation considered is a single, transient pulse. A cost function representative of the beam vibration is obtained by integrating the transient displacement squared over a region of the beam and over all time. The form of the controller is chosen a priori as either one or two delayed pulses. Delays constrain the controller to be causal. The best possible control is then examined while varying the region of control and the controller location. It is found that control is always possible using either one or two control pulses. The two pulse controller gives better performance than a single pulse controller, but finding the optimal delay time for the additional controllers increases as the square of the number of control pulses.

Use of a case manager to improve osteoporosis treatment after hip fracture: results of a randomized controlled trial.

PubMed

Majumdar, Sumit R; Beaupre, Lauren A; Harley, Charles H; Hanley, David A; Lier, Douglas A; Juby, Angela G; Maksymowych, Walter P; Cinats, John G; Bell, Neil R; Morrish, Donald W

2007-10-22

Patients who survive hip fracture are at high risk of recurrent fractures, but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10% to 20%. We have developed an osteoporosis case manager intervention. The case manager educated patients, arranged bone mineral density tests, provided prescriptions, and communicated with primary care physicians. The intervention was compared with usual care in a randomized controlled trial. We recruited from all hospitals that participate in the Capital Health system (Alberta, Canada), including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility. Primary outcome was bisphosphonate therapy 6 months after fracture; secondary outcomes included bone mineral density testing, appropriate care (bone mineral density testing and treatment if bone mass was low), and intervention costs. We screened 2219 patients and allocated 220, as follows: 110 to the intervention group and 110 to the control group. Median age was 74 years, 60% were women, and 37% reported having had previous fractures. Six months after hip fracture, 56 patients in the intervention group (51%) were receiving bisphosphonate therapy compared with 24 patients in the control group (22%) (adjusted odds ratio, 4.7; 95% confidence interval, 2.4-8.9; P < .001). Bone mineral density tests were performed in 88 patients in the intervention group (80%) vs 32 patients in the control group (29%) (P < .001). Of the 120 patients who underwent bone mineral density testing, 25 (21%) had normal bone mass. Patients in the intervention group were more likely to receive appropriate care than were patients in the control group (67% vs 26%; P < .001). The average intervention cost was $50.00 per patient. For a modest cost, a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures.

Deliberate Practice Enhances Quality of Laparoscopic Surgical Performance in a Randomized Controlled Trial: from Arrested Development to Expert Performance

PubMed Central

Hashimoto, Daniel A.; Sirimanna, Pramudith; Gomez, Ernest D.; Beyer-Berjot, Laura; Ericsson, K. Anders; Williams, Noel N.; Darzi, Ara; Aggarwal, Rajesh

2014-01-01

Background This study investigated whether deliberate practice leads to an increase in surgical quality in virtual reality (VR) laparoscopic cholecystectomies (LC). Previous research has suggested that sustained DP is effective in surgical training. Methods Fourteen residents were randomized into deliberate practice (n=7) or control training (n=7). Both groups performed 10 sessions of two VR LCs. Each session, the DP group was assigned 30 minutes of DP activities in between LCs while the control group viewed educational videos or read journal articles. Performance was assessed on speed and dexterity; quality was rated with global (GRS) and procedure-specific (PSRS) rating scales. All participants then performed five porcine LCs. Results Both groups improved over 20 VR LCs in time, dexterity, and global rating scales (all p<0.05). After 20 LCs, there were no differences in speed or dexterity between groups. The DP group achieved higher quality of VR surgical performance than control for GRS (26 vs. 20, p=0.001) and PSRS (18 vs. 15, p=0.001). For VR cases, DP subjects plateaued at GRS=25 after 10 cases and control group at GRS=20 after five cases. At completion of VR training, 100% of the DP group reached target quality of performance (GRS≥21) compared to 30% in the control group. There were no significant differences for improvements in time or dexterity over five porcine LCs. Conclusion This study suggests that DP leads to higher quality performance in VR LC than standard training alone. Standard training may leave individuals in a state of “arrested development” compared to DP. PMID:25539697

Atopic conditions and brain tumor risk in children and adolescents--an international case-control study (CEFALO).

PubMed

Shu, X; Prochazka, M; Lannering, B; Schüz, J; Röösli, M; Tynes, T; Kuehni, C E; Andersen, T V; Infanger, D; Schmidt, L S; Poulsen, A H; Klaeboe, L; Eggen, T; Feychting, M

2014-04-01

A number of epidemiological studies indicate an inverse association between atopy and brain tumors in adults, particularly gliomas. We investigated the association between atopic disorders and intracranial brain tumors in children and adolescents, using international collaborative CEFALO data. CEFALO is a population-based case-control study conducted in Denmark, Norway, Sweden, and Switzerland, including all children and adolescents in the age range 7-19 years diagnosed with a primary brain tumor between 2004 and 2008. Two controls per case were randomly selected from population registers matched on age, sex, and geographic region. Information about atopic conditions and potential confounders was collected through personal interviews. In total, 352 cases (83%) and 646 controls (71%) participated in the study. For all brain tumors combined, there was no association between ever having had an atopic disorder and brain tumor risk [odds ratio 1.03; 95% confidence interval (CI) 0.70-1.34]. The OR was 0.76 (95% CI 0.53-1.11) for a current atopic condition (in the year before diagnosis) and 1.22 (95% CI 0.86-1.74) for an atopic condition in the past. Similar results were observed for glioma. There was no association between atopic conditions and risk of all brain tumors combined or of glioma in particular. Stratification on current or past atopic conditions suggested the possibility of reverse causality, but may also the result of random variation because of small numbers in subgroups. In addition, an ongoing tumor treatment may affect the manifestation of atopic conditions, which could possibly affect recall when reporting about a history of atopic diseases. Only a few studies on atopic conditions and pediatric brain tumors are currently available, and the evidence is conflicting.

Impact of Contextual Factors on Prostate Cancer Risk and Outcomes

DTIC Science & Technology

2013-07-01

framework with random effects (“frailty models”) while the case-control analyses (Aim 4) will use multilevel unconditional logistic regression models...contextual-level SES on prostate cancer risk within racial/ethnic groups. The survival analyses (Aims 1-3) will utilize a proportional hazards regression

Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial.

PubMed

Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

2018-01-10

Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing suicidal ideation as well as in a period after receiving messages. As follow-up phone calls over an extended period of time may not be feasible, this intervention has the potential to offer simple technological support for individuals following discharge from the ED. ClinicalTrials.gov NCT02106949; https://clinicaltrials.gov/ct2/show/NCT02106949 (Archived by WebCite at http://www.webcitation.org/6wMtAFL49). ©Sofian Berrouiguet, Mark Erik Larsen, Catherine Mesmeur, Michel Gravey, Romain Billot, Michel Walter, HUGOPSY Network, Christophe Lemey, Philippe Lenca. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 10.01.2018.

Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial

PubMed Central

Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

2018-01-01

Background Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. Objective The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. Methods SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Results Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. Conclusions This text message–based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing suicidal ideation as well as in a period after receiving messages. As follow-up phone calls over an extended period of time may not be feasible, this intervention has the potential to offer simple technological support for individuals following discharge from the ED. Trial Registration ClinicalTrials.gov NCT02106949; https://clinicaltrials.gov/ct2/show/NCT02106949 (Archived by WebCite at http://www.webcitation.org/6wMtAFL49) PMID:29321126

Results of a randomized trial of HERMES-assisted versus non-HERMES-assisted laparoscopic antireflux surgery.

PubMed

Luketich, J D; Fernando, H C; Buenaventura, P O; Christie, N A; Grondin, S C; Schauer, P R

2002-09-01

Speech recognition technology is a recent development in minimally invasive surgery. This study was designed to assess the impact of HERMES on operating room efficiency and user satisfaction. Patients undergoing laparoscopic antireflux operations by surgeons experienced in minimally invasive surgery were randomized to HERMES-assisted or standard laparoscopic operations. The variables of interest were circulating nurse's time spent adjusting devices that are voice-controlled by HERMES, number of adjustments to devices requested, and surgeon and nurse satisfaction measured on a scale from 1 (dissatisfied) to 10 (satisfied). A total of 30 cases were studied. In the non-HERMES cases, nurses were interrupted to make device adjustments an average of 15.3 times per case versus 0.33 times per case in the with-HERMES cases (p < 0.01). The interruptions during the non-HERMES cases averaged 4.35 min per case versus 0.16 min per case in the with-HERMES cases (p = 0.03). Average satisfaction scores for HERMES operations as opposed to non-HERMES operations were 9.2 versus 5.3 for nurses (p < 0.01) and 9.0 versus 5.1 for surgeons (p < 0.01). Physician and nurse acceptance of HERMES was very high because of the smoother interruption-free environment.

Population-level effects of automated smoking cessation help programs: a randomized controlled trial.

PubMed

Borland, Ron; Balmford, James; Benda, Peter

2013-03-01

To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) onQ, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and onQ; and (v) a choice of either alone or the combined program. Australia, via a mix of internet and telephone contacts. A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources (n = 1335) or cold-contacted from internet panels (n = 2195). The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio (OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence (OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. © 2012 The Authors, Addiction © 2012 Society for the Study of Addiction.

Comparative Effectiveness of Anticholinergic Therapy for Overactive Bladder in Women: A Systematic Review and Meta-analysis.

PubMed

Reynolds, W Stuart; McPheeters, Melissa; Blume, Jeffery; Surawicz, Tanya; Worley, Katherine; Wang, Li; Hartmann, Katherine

2015-06-01

To summarize evidence about reduction in voiding and resolution of urine loss in overactive bladder comparing data from the active drug arms with the placebo arms of randomized trials. We searched MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and ClinicalTrials.gov in March 2014. Multiple reviewers screened original research published in English on community-dwelling women with nonneurogenic overactive bladder undergoing pharmacotherapy with medications available in the United States. Studies in which women comprised less than 75% of the population or those with a sample size less than 50 were excluded. Study designs included randomized controlled trials for meta-analysis and cohorts, case-control, and case series for harms data. Our search identified 50 randomized controlled trials from among 144 candidate publications (one was of good quality, 38 fair, and 11 poor). Multiple team members performed data extraction independently with secondary review of data entry to ensure quality and validity. Studies were assessed for risk of bias. Meta-analysis was performed using fixed-effects regression models. The primary outcomes and measurements were the numbers of daily voids and urge incontinence episodes. Medications delivered as a daily dose reduced urge incontinence by 1.73 episodes per day (95% confidence interval [CI] 1.37-2.09) and voids by 2.06 per day (95% CI 1.66-2.46) from 2.79 (95% CI 0.70-4.88) and 11.28 (95% CI 7.77-14.80) at baseline, respectively. Placebo reduced urge incontinence episodes by 1.06 (95% CI 0.7-1.42) and voids by 1.2 (95% CI 0.72-1.67) per day. No individual agent demonstrated superiority over another. The majority (98%) of studies reporting funding were sponsored by industry. Evidence from more than 27,000 women participating in randomized controlled trials suggests that improvement in symptoms with anticholinergic management of overactive bladder is modest and rarely fully resolves symptoms.

Randomized controlled trial of anterior-chamber intraocular lenses in Nepal: long-term follow-up.

PubMed Central

Evans, J. R.; Henning, A.; Pradhan, D.; Foster, A.; Lagnado, R.; Poulson, A.; Johnson, G. J.; Wormald, R. P.

2000-01-01

Most of the estimated 20 million people who are blind with cataracts live in rural areas of developing countries, where expert surgical resources are scarce. We have studied the use of multiflex open-loop anterior-chamber intraocular lenses (ACIOL) in high-volume low-cost surgery. Between 1992 and 1995, a total of 2000 people attending Lahan Eye Hospital, Nepal, with bilateral cataracts reducing vision to < or = 6/36 were randomly allocated to receive intracapsular extraction (ICCE) with aphakic spectacles, or ICCE with an ACIOL. We re-examined the cohort (1305/2000, 65%) between November 1996 and April 1997 and report the findings in this article. There were 13 new cases of poor visual outcome (best corrected vision < 6/60) arising after one year: 9 in the ACIOL group and 4 in the control group; odds ratio 2.1 (95% confidence interval, 0.59-9.55). The causes of poor outcome were as follows: ACIOL group--retinal detachment (4 cases), cystoid macular oedema (2), epiretinal membrane (1), age-related macular degeneration (1), and late endophthalmitis (1); control group--retinal detachment (2 cases), late endophthalmitis (1), and primary open-angle glaucoma with age-related macular degeneration (1). In rural areas of developing countries, well-manufactured multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. PMID:10812737

A randomized controlled trial to examine the effectiveness of case management model for community dwelling older persons with mild dementia in Hong Kong.

PubMed

Lam, Linda C W; Lee, Jenny S W; Chung, Jenny C C; Lau, Anna; Woo, Jean; Kwok, Timothy C Y

2010-04-01

To evaluate a case management (CM) model for people with mild dementia, whereby resources within the family and in the community were mobilized and optimally used. Community dwelling psychiatric and geriatrics outpatients with mild dementia were randomized to receive CM by a trained occupational therapist for 4 months (CM group, N = 59) or usual care only (control group, N = 43). Primary outcome indicators included the Zarit Burden Scale (ZBI), General Health Questionnaire (GHQ), and Personal Well-Being Index for Adult (PWI-A) of the family caregivers. Secondary outcome indicators included the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), and Personal Well-Being Index for Intellectually Disabled (PWI-ID) of the demented subjects as measured at fourth and twelfth months. CSDDis reduced in the CM group at fourth month, but not at twelfth month. The changes in outcome variables of persons with dementia did not differ between the groups (Mann-Whitney U-test, p > 0.05). At follow-up, CM group used more day care and domestic helpers than control group (chi (2), p > 0.05). Case management for Chinese persons with mild dementia outpatients did not show significant effects in reducing caregiver burden, but encouraged family caregivers to seek external support.

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

PubMed

Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

2017-02-01

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Non-Celiac Gluten Sensitivity Has Narrowed the Spectrum of Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial.

PubMed

Shahbazkhani, Bijan; Sadeghi, Amirsaeid; Malekzadeh, Reza; Khatavi, Fatima; Etemadi, Mehrnoosh; Kalantri, Ebrahim; Rostami-Nejad, Mohammad; Rostami, Kamran

2015-06-05

Several studies have shown that a large number of patients who are fulfilling the criteria for irritable bowel syndrome (IBS) are sensitive to gluten. The aim of this study was to evaluate the effect of a gluten-free diet on gastrointestinal symptoms in patients with IBS. In this double-blind randomized, placebo-controlled trial, 148 IBS patients fulfilling the Rome III criteria were enrolled between 2011 and 2013. However, only 72 out of the 148 commenced on a gluten-free diet for up to six weeks and completed the study; clinical symptoms were recorded biweekly using a standard visual analogue scale (VAS). In the second stage after six weeks, patients whose symptoms improved to an acceptable level were randomly divided into two groups; patients either received packages containing powdered gluten (35 cases) or patients received placebo (gluten free powder) (37 cases). Overall, the symptomatic improvement was statistically different in the gluten-containing group compared with placebo group in 9 (25.7%), and 31 (83.8%) patients respectively (p < 0.001). A large number of patients labelled as irritable bowel syndrome are sensitive to gluten. Using the term of IBS can therefore be misleading and may deviate and postpone the application of an effective and well-targeted treatment strategy in gluten sensitive patients.

[Clinical observation on acupuncture by stages combined with exercise therapy for treatment of Bell palsy at acute stage].

PubMed

Qu, Yong

2005-08-01

To find out a method for increasing clinical therapeutic effect on Bell palsy at acute stage. Ninety cases of Bell palsy were randomly divided into an observation group, a control group I and a control group II, 30 cases in each group. They were treated respectively with acupuncture plus exercise therapy, simple acupuncture therapy, and simple exercise therapy, and their therapeutic effects were observed. The cured rate was 66.7% in the observation group, 53.3% in the control group I and 46.70% in the control group II, the observation group being better than the two control groups (P<0.05). Acupuncture by stage combined with exercise therapy can increase the therapeutic effect on Bell palsy at acute stage, and it is a better therapy for Bell palsy.

Outcomes of Video-Assisted Teaching for Latching in Postpartum Women: A Randomized Controlled Trial.

PubMed

Sroiwatana, Suttikamon; Puapornpong, Pawin

2018-04-25

Latching is an important process of breastfeeding and should be taught and practiced by the postpartum mother. The objective is to compare latching outcomes between video-assisted and routine teaching methods among postpartum women. A randomized controlled trial was conducted. Postpartum women who had deliveries without complications were randomized into two groups: 14 cases in the video-assisted teaching group and 14 cases in a routine teaching group. In the first group, the mothers were taught breastfeeding benefits, latching methods, and breastfeeding positions and practiced breastfeeding in a controlled setting for a 30-minute period and watched a 6-minute video with consistent content. In the second group, the mothers were taught a normal 30-minute period and then practiced breastfeeding. In both groups, Latching on, Audible swallowing, the Type of nipples, Comfort, and Help (LATCH) scores were assessed at 24-32 and 48-56 hours after the breastfeeding teaching modals. Demographic data and LATCH scores were collected and analyzed. There were no statistically significant differences in the mothers' ages, occupations, marital status, religion, education, income, infants' gestational age, body mass index, nipple length, route of delivery, and time to first latching between the video-assisted and routine breastfeeding teaching groups. First and second LATCH score assessments had shown no significant differences between both breastfeeding teaching groups. The video-assisted breastfeeding teaching did not improve latching outcomes when it was compared with routine teaching.

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

PubMed Central

Seiler, CM; Fröhlich, BE; Veit, JA; Gazyakan, E; Wente, MN; Wollermann, C; Deckert, A; Witte, S; Victor, N; Buchler, MW; Knaebel, HP

2006-01-01

Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice. PMID:16948853

Effect of case management on glycemic control and behavioral outcomes for chinese people with type 2 diabetes: A 2-year study.

PubMed

Yuan, Xiaodan; Wang, Fengmei; Fish, Anne Folta; Xue, Cunyi; Chen, Tao; Liu, Chao; Lou, Qingqing

2016-08-01

To examine the effect of case management on glycemic control and behavioral outcomes in adults with Type 2 diabetes in China. Participants were randomly assigned to a 1-year case management (CM) group (n=60) or control group (n=60). Monthly case management visits included identifying individuals' diabetes-related problems, setting goals, planning self-care, and evaluating progress. During a 1-year follow-up, all participants attended visits every 3 months without intervention. In the CM vs. the control group, HbA1c was reduced at 6 months compared to baseline (P=0.034), with trends at 12 and 24 months, and empowerment ability improved (P<0.05). Also in the CM vs. controls, total self-care behaviors, the frequency of exercise, blood glucose testing, and foot care were higher (P<0.001) at 12 months, and the percentage of individuals with HbA1c ≤7.0% was higher (P=0.035) at 24 months. The case management intervention in China was effective at 6 months and, based on trends in HbA1c at 12 and 24 months and results for behavioral outcomes, the intervention shows promise and warrants more research. A case management approach can enhance behavior change and glycemic control in Chinese with diabetes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Reducing selection bias in case-control studies from rare disease registries.

PubMed

Cole, J Alexander; Taylor, John S; Hangartner, Thomas N; Weinreb, Neal J; Mistry, Pramod K; Khan, Aneal

2011-09-12

In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG) Gaucher Registry were used as an example. A case-control matching analysis using the risk-set method was conducted to identify two groups of patients with type 1 Gaucher disease in the ICGG Gaucher Registry: patients with avascular osteonecrosis (AVN) and those without AVN. The frequency distributions of gender, decade of birth, treatment status, and splenectomy status were presented for cases and controls before and after matching. Odds ratios (and 95% confidence intervals) were calculated for each variable before and after matching. The application of case-control matching methodology results in cohorts of cases (i.e., patients with AVN) and controls (i.e., patients without AVN) who have comparable distributions for four common parameters used in subject selection: gender, year of birth (age), treatment status, and splenectomy status. Matching resulted in odds ratios of approximately 1.00, indicating no bias. We demonstrated bias in case-control selection in subjects from a prototype rare disease registry and used case-control matching to minimize this bias. Therefore, this approach appears useful to study cohorts of heterogeneous patients in rare disease registries.

Quasi-experimental designs in practice-based research settings: design and implementation considerations.

PubMed

Handley, Margaret A; Schillinger, Dean; Shiboski, Stephen

2011-01-01

Although randomized controlled trials are often a gold standard for determining intervention effects, in the area of practice-based research (PBR), there are many situations in which individual randomization is not possible. Alternative approaches to evaluating interventions have received increased attention, particularly those that can retain elements of randomization such that they can be considered "controlled" trials. Methodological design elements and practical implementation considerations for two quasi-experimental design approaches that have considerable promise in PBR settings--the stepped-wedge design, and a variant of this design, a wait-list cross-over design, are presented along with a case study from a recent PBR intervention for patients with diabetes. PBR-relevant design features include: creation of a cohort over time that collects control data but allows all participants (clusters or patients) to receive the intervention; staggered introduction of clusters; multiple data collection points; and one-way cross-over into the intervention arm. Practical considerations include: randomization versus stratification, training run in phases; and extended time period for overall study completion. Several design features of practice based research studies can be adapted to local circumstances yet retain elements to improve methodological rigor. Studies that utilize these methods, such as the stepped-wedge design and the wait-list cross-over design, can increase the evidence base for controlled studies conducted within the complex environment of PBR.

Prazosin for Prophylaxis of Chronic Post Traumatic Headaches in OEF/OIF/OND Service Members and Veterans with Mild TBI

DTIC Science & Technology

2017-10-01

does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. 1. REPORT DATE October 2017 2. REPORT TYPE...comes from a large open-label case series in Iraq and Afghanistan Veterans with mTBI and posttraumatic headaches and data from a placebo- controlled trial...will be accomplished by conducting a randomized placebo- controlled double blind trial of prazosin vs placebo in 160 Iraq/Afghanistan active-duty

Examining the effectiveness of home-based parent aide services to reduce risk for physical child abuse and neglect: six-month findings from a randomized clinical trial.

PubMed

Guterman, Neil B; Tabone, Jiyoung K; Bryan, George M; Taylor, Catherine A; Napoleon-Hanger, Cynthia; Banman, Aaron

2013-08-01

This study set out to carry out a feasible, real-world, randomized clinical trial to examine the benefits of home-based paraprofessional parent aide services in reducing physical abuse and neglect risk in high-risk parents. Families were randomly assigned to receive either parent aide plus case management services (n = 73) or case management services only (n = 65), collecting in-home data on physical child abuse and neglect and proximal risk and protective factors, just prior to service initiation, and again after six months of services. Mothers receiving parent aide and case management services reported significant improvements from baseline to six-month follow-up in self-reported indicators of physical child abuse risk, as well as improvements on parental stress, mastery, depression, and anxiety, whereas mothers receiving only case management services did not. The slopes of such observed changes across groups, however, were not found to be statistically significantly different. No discernable improvements were found with regard to indicators of risk for child neglect. As the first randomized clinical trial examining the effectiveness of parent aide services, this study provides the first controlled evidence examining the potential benefits of this service modality. This study suggests promising trends regarding the benefit of parent aide services with respect to physical child abuse risk reduction and related predictors, but evidence does not appear to suggest that such services, as they are presently delivered, reduce child neglect. These findings support the continued use of parent aide services in cases of physical child abuse and also suggest careful consideration of the ways such services may be better configured to extend their impact, particularly with respect to child neglect risk. Copyright © 2013 Elsevier Ltd. All rights reserved.

Tubal anastomosis after previous sterilization: a systematic review.

PubMed

van Seeters, Jacoba A H; Chua, Su Jen; Mol, Ben W J; Koks, Carolien A M

2017-05-01

Female sterilization is one of the most common contraceptive methods. A small number of women, however, opt for reversal of sterilization procedures after they experience regret. Procedures can be performed by laparotomy or laparoscopy, with or without robotic assistance. Another commonly utilized alternative is IVF. The choice between surgery and IVF is often influenced by reimbursement politics for that particular geographic location. We evaluated the fertility outcomes of different surgical methods available for the reversal of female sterilization, compared these to IVF and assessed the prognostic factors for success. Two search strategies were employed. Firstly, we searched for randomized and non-randomized clinical studies presenting fertility outcomes of sterilization reversal up to July 2016. Data on the following outcomes were collected: pregnancy rate, ectopic pregnancy rate, cost of the procedure and operative time. Eligible study designs included prospective or retrospective studies, randomized controlled trials, cohort studies, case-control studies and case series. No age restriction was applied. Exclusion criteria were patients suffering from tubal infertility from any other reason (e.g. infection, endometriosis and adhesions from previous surgery) and studies including <10 participants. The following factors likely to influence the success of sterilization reversal procedures were then evaluated: female age, BMI and duration and method of sterilization. Secondly, we searched for randomized and non-randomized clinical studies that compared reversal of sterilization to IVF and evaluated them for pregnancy outcomes and cost effectiveness. We included 37 studies that investigated a total of 10 689 women. No randomized controlled trials were found. Most studies were retrospective cohort studies of a moderate quality. The pooled pregnancy rate after sterilization reversal was 42-69%, with heterogeneity seen from the different methods utilized. The reported ectopic pregnancy rate was 4-8%. The only prognostic factor affecting the chance of conception was female age. The surgical approach (i.e. laparotomy [microscopic], laparoscopy or robotic) had no impact on the outcome, with the exception of the macroscopic laparotomic technique, which had inferior results and is not currently utilized. For older women, IVF could be a more cost-effective alternative for the reversal of sterilization. However, direct comparative data are lacking and a cut-off age cannot be stated. In sterilized women who suffer regret, surgical tubal re-anastomosis is an effective treatment, especially in younger women. However, there is a need for randomized controlled trials comparing the success rates and costs of surgical reversal with IVF. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

A multi-site evaluation of innovative approaches to increase tuberculosis case notification: summary results.

PubMed

Creswell, Jacob; Sahu, Suvanand; Blok, Lucie; Bakker, Mirjam I; Stevens, Robert; Ditiu, Lucica

2014-01-01

Globally, TB notifications have stagnated since 2007, and sputum smear positive notifications have been declining despite policies to improve case detection. We evaluate results of 28 interventions focused on improving TB case detection. We measured additional sputum smear positive cases treated, defined as the intervention area's increase in case notification during the project compared to the previous year. Projects were encouraged to select control areas and collect historical notification data. We used time series negative binomial regression for over-dispersed cross-sectional data accounting for fixed and random effects to test the individual projects' effects on TB notification while controlling for trend and control populations. Twenty-eight projects, 19 with control populations, completed at least four quarters of case finding activities, covering a population of 89.2 million. Among all projects sputum smear positive (SS+) TB notifications increased 24.9% and annualized notification rates increased from 69.1 to 86.2/100,000 (p = 0.0209) during interventions. Among the 19 projects with control populations, SS+TB case notifications increased 36.9% increase while in the control populations a 3.6% decrease was observed. Fourteen (74%) of the 19 projects' SS+TB notification rates in intervention areas increased from the baseline to intervention period when controlling for historical trends and notifications in control areas. Interventions were associated with large increases in TB notifications across many settings, using an array of interventions. Many people with TB are not reached using current approaches. Different methods and interventions tailored to local realities are urgently needed.

Survey of Obstetrician-Gynecologists in the United States About Toxoplasmosis

PubMed Central

Dietz, Vance J.; Power, Michael; Lopez, Adriana; Wilson, Marianna; Navin, Thomas R.; Gibbs, Ronald; Schulkin, Jay

2001-01-01

Background: Although the incidence of toxoplasmosis is low in the United States, up to 6000 congenital cases occur annually. In September 1998, the Centers for Disease Control and Prevention held a conference about toxoplasmosis; participants recommended a survey of the toxoplasmosis-related knowledge and practices of obstetrician-gynecologists and the development of professional educational materials for them. Methods: In the fall of 1999, surveys were mailed to a 2% random sample of American College of Obstetricians and Gynecologists (ACOG) members and to a demographically representative group of ACOGmembers known as the Collaborative Ambulatory Research Network (CARN). Responses were not significantly different for the random and CARN groups for most questions (p value shown when different). Results: Among 768 US practicing ACOG members surveyed, 364 (47%) responded. Seven per cent (CARN 10%, random 5%) had diagnosed one or more case(s) of acute toxoplasmosis in the past year. Respondents were well-informed about how to prevent toxoplasmosis. However, only 12% (CARN 11%, random 12%) indicated that a positive Toxoplasma IgM test might be a false–positive result, and only 11% (CARN 14%, random 9%) were aware that the Food and Drug Administration sent an advisory to all ACOG members in 1997 stating that some Toxoplasma IgM test kits have high false–positive rates. Most of those surveyed (CARN 70%, random 59%; X2 p < 0.05) were opposed to universal screening of pregnant women. Conclusions: Many US obstetrician-gynecologists will encounter acute toxoplasmosis during their careers, but they are frequently uncertain about interpretation of the laboratory tests for the disease. Most would not recommend universal screening of pregnant women. PMID:11368255

Is using multiple imputation better than complete case analysis for estimating a prevalence (risk) difference in randomized controlled trials when binary outcome observations are missing?

PubMed

Mukaka, Mavuto; White, Sarah A; Terlouw, Dianne J; Mwapasa, Victor; Kalilani-Phiri, Linda; Faragher, E Brian

2016-07-22

Missing outcomes can seriously impair the ability to make correct inferences from randomized controlled trials (RCTs). Complete case (CC) analysis is commonly used, but it reduces sample size and is perceived to lead to reduced statistical efficiency of estimates while increasing the potential for bias. As multiple imputation (MI) methods preserve sample size, they are generally viewed as the preferred analytical approach. We examined this assumption, comparing the performance of CC and MI methods to determine risk difference (RD) estimates in the presence of missing binary outcomes. We conducted simulation studies of 5000 simulated data sets with 50 imputations of RCTs with one primary follow-up endpoint at different underlying levels of RD (3-25 %) and missing outcomes (5-30 %). For missing at random (MAR) or missing completely at random (MCAR) outcomes, CC method estimates generally remained unbiased and achieved precision similar to or better than MI methods, and high statistical coverage. Missing not at random (MNAR) scenarios yielded invalid inferences with both methods. Effect size estimate bias was reduced in MI methods by always including group membership even if this was unrelated to missingness. Surprisingly, under MAR and MCAR conditions in the assessed scenarios, MI offered no statistical advantage over CC methods. While MI must inherently accompany CC methods for intention-to-treat analyses, these findings endorse CC methods for per protocol risk difference analyses in these conditions. These findings provide an argument for the use of the CC approach to always complement MI analyses, with the usual caveat that the validity of the mechanism for missingness be thoroughly discussed. More importantly, researchers should strive to collect as much data as possible.

The effect of phloroglucinol on pain in first-trimester surgical abortion: a double-blind randomized controlled study.

PubMed

Zhuang, Yaling; Zhu, Xiufang; Huang, Li-Li

2010-02-01

First-trimester surgical abortion is a common procedure. Pain control during this procedure is still an unsolved problem. In this randomized, double-blind placebo-controlled study, women presenting for first-trimester surgical abortion received intramuscular phloroglucinol (4 mL) or placebo (normal saline, 4 mL). Visual analog scales (VAS) for pain immediately and 30 min after the procedure and side effects of the drug were recorded. There was no significant difference between groups in the pain level immediately and 30 min after the procedure; 70.7% of the phloroglucinol group (n=58 cases) and 56.9% of the placebo group (n=58 cases ) reported mild pain; 27.6% and 34.5%, respectively, reported moderate pain; and 1.7% and 8.6%, respectively, reported severe pain. Thirty minutes after the procedure, the median pain score was reduced to 1.3 in both groups. Postoperative side effects were reported, but there was no significant difference between groups for nausea or vomiting and blood pressure. The use of this dose of phloroglucinol, during first-trimester abortion by suction evacuation under local anesthesia with lidocaine, did not relieve pain, but caused no side effects.

Medicine Based Evidence for Individualized Decision Making: Case Study of Systemic Lupus Erythematosus.

PubMed

Wivel, Ashley E; Lapane, Kate; Kleoudis, Christi; Singer, Burton H; Horwitz, Ralph I

2017-11-01

To guide management decisions for an index patient, evidence is required from comparisons between approximate matches to the profile of the index case, where some matches contain responses to treatment and others act as controls. We describe a method for constructing clinically relevant histories/profiles using data collected but unreported from 2 recent phase 3 randomized controlled trials assessing belimumab in subjects with clinically active and serologically positive systemic lupus erythematosus. Outcome was the Systemic lupus erythematosus Responder Index (SRI) measured at 52 weeks. Among 1175 subjects, we constructed an algorithm utilizing 11 trajectory variables including 4 biological, 2 clinical, and 5 social/behavioral. Across all biological and social/behavioral variables, the proportion of responders based on the SRI whose value indicated clinical worsening or no improvement ranged from 27.5% to 42.3%. Kappa values suggested poor agreement, indicating that each biological and patient-reported outcome provides different information than gleaned from the SRI. The richly detailed patient profiles needed to guide decision-making in clinical practice are sharply at odds with the limited information utilized in conventional randomized controlled trial analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

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

PubMed

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

2018-05-07

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

Bayesian adjustment for measurement error in continuous exposures in an individually matched case-control study.

PubMed

Espino-Hernandez, Gabriela; Gustafson, Paul; Burstyn, Igor

2011-05-14

In epidemiological studies explanatory variables are frequently subject to measurement error. The aim of this paper is to develop a Bayesian method to correct for measurement error in multiple continuous exposures in individually matched case-control studies. This is a topic that has not been widely investigated. The new method is illustrated using data from an individually matched case-control study of the association between thyroid hormone levels during pregnancy and exposure to perfluorinated acids. The objective of the motivating study was to examine the risk of maternal hypothyroxinemia due to exposure to three perfluorinated acids measured on a continuous scale. Results from the proposed method are compared with those obtained from a naive analysis. Using a Bayesian approach, the developed method considers a classical measurement error model for the exposures, as well as the conditional logistic regression likelihood as the disease model, together with a random-effect exposure model. Proper and diffuse prior distributions are assigned, and results from a quality control experiment are used to estimate the perfluorinated acids' measurement error variability. As a result, posterior distributions and 95% credible intervals of the odds ratios are computed. A sensitivity analysis of method's performance in this particular application with different measurement error variability was performed. The proposed Bayesian method to correct for measurement error is feasible and can be implemented using statistical software. For the study on perfluorinated acids, a comparison of the inferences which are corrected for measurement error to those which ignore it indicates that little adjustment is manifested for the level of measurement error actually exhibited in the exposures. Nevertheless, a sensitivity analysis shows that more substantial adjustments arise if larger measurement errors are assumed. In individually matched case-control studies, the use of conditional logistic regression likelihood as a disease model in the presence of measurement error in multiple continuous exposures can be justified by having a random-effect exposure model. The proposed method can be successfully implemented in WinBUGS to correct individually matched case-control studies for several mismeasured continuous exposures under a classical measurement error model.

Impulse-Control Disorders in Parkinson's Disease: A Meta-Analysis and Review of Case-Control Studies.

PubMed

Molde, Helge; Moussavi, Yasaman; Kopperud, Stine Therese; Erga, Aleksander Hagen; Hansen, Anita Lill; Pallesen, Ståle

2018-01-01

Although several case-control studies on the prevalence of Impulse-Control Disorders (ICDs) in Parkinson's Disease (PD) have been conducted, no meta-analytic study on this topic has previously been published. Thus, knowledge about the overall prevalence rate of ICD in PD and factors that might moderate this relationship is lacking. Prevalence studies of ICDs in PD were identified by computer searches in the MEDLINE, PsycINFO, and Web of Science databases, covering the period from January 2000 to February 2017. Data for N  = 4,539, consisting of 2,371 PD patients and 2,168 healthy controls, representing 14 case-control studies were included. Estimation of the odds ratio ( OR ) of ICDs in PD compared to healthy controls was conducted using random-effects models. Mixed-effects models were applied in the moderator analysis of heterogeneity. Publication bias was estimated using a contour-enhanced funnel plot, the Rüker's test, and fail-safe N test for estimating the number of potential missing studies. Overall, the results showed significantly higher ratios for several ICDs in PD compared to healthy controls with the estimated overall OR s ranging between 2.07, 95% CI [1.26, 3.48], for having any ICDs, and 4.26, 95% CI [2.17, 8.36], for hypersexuality. However, the random-effects results for shopping were non-significant, though the fixed-effects model was significant ( OR  = 1.66, 95%CI [1.21, 2.27]). The testing of potential moderator variables of heterogeneity identified the following two variables that were both associated with increased risk: being medically treated for PD and disease duration. The results must be interpreted with some caution due to possible small-studies effect or publication bias. Individuals with PD seem to have a significantly greater risk of suffering from ICDs compared to healthy controls. Gambling, hypersexuality, eating, punding, and hobbying are all ICDs significantly associated with PDs being medically treated for PD.

Does Encouragement Matter in Improving Gender Imbalances in Technical Fields? Evidence from a Randomized Controlled Trial

PubMed Central

Unkovic, Cait; Sen, Maya; Quinn, Kevin M.

2016-01-01

Does encouragement help address gender imbalances in technical fields? We present the results of one of the first and largest randomized controlled trials on the topic. Using an applied statistics conference in the social sciences as our context, we randomly assigned half of a pool of 3,945 graduate students to receive two personalized emails encouraging them to apply (n = 1,976) and the other half to receive nothing (n = 1,969). We find a robust, positive effect associated with this simple intervention and suggestive evidence that women responded more strongly than men. However, we find that women’s conference acceptance rates are higher within the control group than in the treated group. This is not the case for men. The reason appears to be that female applicants in the treated group solicited supporting letters at lower rates. Our findings therefore suggest that “low dose” interventions may promote diversity in STEM fields but may also have the potential to expose underlying disparities when used alone or in a non-targeted way. PMID:27097315

Chieh Mei Ching Yi: A randomized controlled trial of a culturally tailored HIV prevention intervention for Chinese massage parlor women in Los Angeles.

PubMed

Takahashi, Lois M; Tobin, Karin E; To, Stacy; Ou, Samuel; Ma, Chui Hing Helen; Ao, Fiona Ka Wa; Candelario, Jury

2013-12-01

Asian heterosexual women in the U.S. have experienced relative rising HIV case rates, but there remain few studies and no evidence-based interventions that focus on this population. This study was a randomized controlled trial of a gender and ethnically tailored HIV prevention intervention for monolingual Chinese-speaking women who work as masseuses in Los Angeles. The intervention was two group-based sessions focused on HIV risk and prevention knowledge and condom skills. The control condition was a single-session HIV review. Participants were recruited using newspaper advertisements and referrals from agencies and massage schools. Two hundred women were randomly assigned to one of each condition. Retention in both conditions exceeded 90% at 3-month follow-up. Participants in both conditions demonstrated increases in knowledge on how to use male and female condoms. These effects were sustained at 3-month follow-up. The results highlight the possible efficacy of a one-workshop intervention in increasing HIV knowledge, but that more intensive participant interaction may be needed for improved condom use knowledge.

Design of a switch matrix gate/bulk driver controller for thin film lithium microbatteries using microwave SOI technology

NASA Technical Reports Server (NTRS)

Whitacre, J.; West, W. C.; Mojarradi, M.; Sukumar, V.; Hess, H.; Li, H.; Buck, K.; Cox, D.; Alahmad, M.; Zghoul, F. N.;

77 FR 26764 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... two sites, with the random assignment of AFI-eligible cases to program and control groups. The... Families (ACF) is proposing a data collection activity as part of an experimental evaluation of the Assets... outcomes? While some evaluations suggest that IDAs help low-income families save, rigorous experimental...

Restaurant-associated outbreak of Salmonella typhi in Nauru: an epidemiological and cost analysis.

PubMed Central

Olsen, S. J.; Kafoa, B.; Win, N. S.; Jose, M.; Bibb, W.; Luby, S.; Waidubu, G.; O'Leary, M.; Mintz, E.

2001-01-01

Typhoid fever is endemic in the South Pacific. We investigated an outbreak in Nauru. Through interviews and medical records, we identified 50 persons with onset between 1 October 1998 and 10 May 1999, of fever lasting > or = 3 days and one other symptom. Salmonella Typhi was isolated from 19 (38%) cases. Thirty-two (64%) patients were school-aged children, and 17 (34%) were in four households. Case-control studies of (a) culture-confirmed cases and age- and neighbourhood-matched controls; and (b) household index cases and randomly selected age-matched controls implicated two restaurants: Restaurant M (matched OR [MOR] = 11, 95% confidence interval [CI] = 1.3-96) and Restaurant I (MOR = 5.8, 95% CI = 1.2-29). Food-handlers at both restaurants had elevated anti-Vi antibody titres indicative of carrier state. The annual incidence was 5.0/1000 persons. Outbreak-associated costs were $46,000. Routine or emergency immunization campaigns targeting school-aged children may help prevent or control outbreaks of typhoid fever in endemic disease areas. PMID:11811872

Correlation between Apgar score and urinary uric acid to creatinine ratio in perinatal asphyxia.

PubMed

Basu, Pallab; Som, Sabyasachi; Choudhuri, Nabendu; Das, Harendranath

2008-10-01

A randomized case control hospital based study was conducted over 12 months time on 31 asphyxiated and 31 normal newborn to see whether urinary uric acid can be used as a marker of perinatal asphyxia and can be correlated with the clinical diagnosis by Apgar score. Uric acid and creatinine were estimated in spot urine within 24 hours after birth in both cases and controls. A ratio between concentrations of uric acid to creatinine was estimated and compared between cases and controls. It was found that the ratios were significantly higher in cases than controls (3.1± 1.3 vs 0.96± 0.54; P < 0.001) and among asphyxia patients, a significant negative linear correlation was found between the uric acid to creatinine ratio and the Apgar score (r = -0.857, P < 0.001). So urinary uric acid to creatinine ratio can be used as an additional non-invasive dispace, easy and at the same time early biochemical marker of birth asphyxia which biochemically supports the clinical diagnosis and severity grading of asphyxia by Apgar score.

Immunoglobulin G antibodies against indoor dampness-related microbes and adult-onset asthma: a population-based incident case–control study

PubMed Central

JAAKKOLA, M S; LAITINEN, S; PIIPARI, R; UITTI, J; NORDMAN, H; HAAPALA, A-M; JAAKKOLA, J J K

2002-01-01

Immunoglobulin G (IgG) antibodies against microbes related to indoor dampness problems have been used as potential biomarkers of fungal exposure in clinical investigations. There is limited information on their relation to asthma. We conducted a population-based incident case–control study to assess the risk of asthma in relation to specific IgG antibodies to eight dampness-related microbes: Aspergillus fumigatus, A. versicolor, Cladosporium cladosporioides, Fusarium oxysporum, Sporobolomyces salmonicolor, Stachybotrys chartarum, Streptomyces albus and Trichoderma citrinoviride. We recruited systematically all new cases of asthma during a 2·5-year study period and randomly selected controls from a source population of adults 21–63 years of age living in the Pirkanmaa Hospital District, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls selected randomly from the source population. IgG antibodies were analysed with ELISA. An increased risk of developing asthma in adulthood was significantly related to IgG antibodies to T. citrinoviride, but not to the other moulds. There was no evidence of a dose–response relation between the IgG antibody level and the risk of asthma. T. citrinoviride may play a role in the aetiology of adult-onset asthma or serve as an indicator of other causal factors. PMID:12100029

Investigation effect of oral chamomilla on sleep quality in elderly people in Isfahan: A randomized control trial.

PubMed

Abdullahzadeh, Mehrdad; Matourypour, Pegah; Naji, Sayed Ali

2017-01-01

Elderly people often suffer from sleep disorders. Chamomile due to the many health benefits such as sedation may be effective in improving sleep quality in elderly people. This study aimed to determine the effect of Matricaria chamomilla extract on sleep quality in elderly people admitted to nursing homes of Isfahan in 2014. The present study is a quasi-experimental clinical trial. The study population was 77 cases of elderly hospitalized in nursing homes. Participants were selected through random continuous sampling and divided into intervention and control groups. The intervention group received 400 mg oral capsules of chamomile twice daily, after lunch and after dinner for 4 weeks. The control group did not receive the intervention. Sleep quality in older adults before and after intervention were compared using the Pittsburgh Sleep Quality Index questionnaire. Data were analyzed using descriptive statistics and paired t - and independent t -tests, one-way analysis of variance and liner regression analysis, using SPSS software version 17. Before intervention, the mean score of sleep quality both experimental and control groups showed no significant difference ( P > 0.05). After intervention, the mean score of sleep quality was a significant difference between experimental and control groups ( P < 0.001). Oral administration of chamomile extract has sedative properties in sleep quality of hospitalized elderly patients in nursing homes. Therefore, it can be used in similar cases and nursing care.

Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

PubMed

Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

2014-09-02

Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months, comprising 6.7% (11/165) from the Active groups (1, 2, 3) and 4.5% (5/110) from the Control groups (4, 5), a difference that was not significant. CES-D, ASI, and PSWQ scores were significantly lower for the active website with email reminders at post-test, relative to the control website condition. Indicated prevention of GAD was not effective in reducing anxiety levels, measured by GAD-7. There were significant secondary effects for anxiety sensitivity, worry, and depression. Challenges for indicated prevention trials are discussed. International Standard Randomized Controlled Trial Number (ISRCTN): 76298775; http://www.controlled-trials.com/ISRCTN76298775 (Archived by WebCite at http://www.webcitation.org/6S9aB5MAq).

The effects of testosterone on body composition in obese men are not sustained after cessation of testosterone treatment.

PubMed

Ng Tang Fui, Mark; Hoermann, Rudolf; Zajac, Jeffrey D; Grossmann, Mathis

2017-10-01

Testosterone treatment in obese dieting men augments the diet-associated loss of fat mass, but protects against loss of lean mass. We assessed whether body composition changes are maintained following withdrawal of testosterone treatment. We conducted a prespecified double-blind randomized placebo-controlled observational follow-up study of a randomized controlled trial (RCT). Participants were men with baseline obesity (body mass index >30 kg/m 2 ) and a repeated total testosterone level <12 nmol/L, previously enrolled in a 56-week testosterone treatment trial combined with a weight loss programme. Main outcome measures were mean adjusted differences (MAD) (95% confidence interval), in body composition between testosterone- and placebo-treated men at the end of the observation period. Of the 100 randomized men, 82 completed the RCT and 64 the subsequent observational study. Median [IQR] observation time after completion of the RCT was 82 weeks [74; 90] in men previously receiving testosterone (cases) and 81 weeks [67;91] in men previously receiving placebo (controls), P=.51. At the end of the RCT, while losing similar amounts of weight, cases had, compared to controls, lost more fat mass, MAD -2.9 kg (-5.7, -0.2), P=.04, but had lost less lean mass MAD 3.4 kg (1.3, 5.5), P=.002. At the end of the observation period, the former between-group differences in fat mass, MAD -0.8 kg (-3.6, 2.0), P=1.0, in lean mass, MAD -1.3 kg (-3.0, 0.5), P=.39, and in appendicular lean mass, MAD -0.1 kg/m 2 (-0.3, 0.1), P=.45, were no longer apparent. During observation, cases lost more lean mass, MAD -3.7 kg (-5.5, -1.9), P=.0005, and appendicular lean mass, MAD -0.5 kg/m 2 (-0.8, -0.3), P<.0001 compared to controls. The favourable effects of testosterone on body composition in men subjected to a concomitant weight loss programme were not maintained at 82 weeks after testosterone treatment cessation. © 2017 John Wiley & Sons Ltd.

Mindfulness interventions for psychosis: a systematic review of the literature.

PubMed

Aust, J; Bradshaw, T

2017-02-01

WHAT IS KNOWN ON THE SUBJECT?: Psychosis and the more specific diagnosis of schizophrenia constitute a major psychiatric disorder which impacts heavily on the self-esteem, functioning and quality of life of those affected. A number of mindfulness therapies have been developed in recent years, showing promising results when used with people with the disorder. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: This review of the literature included only randomized controlled trials (RCTs), rather than other typically less robust methods of research (e.g. case studies, noncontrolled studies). WHAT ARE THE IMPLICATIONS FOR PRACTICE?: We concluded that mindfulness therapies can be safely used with people with psychosis and that they provide a number of therapeutic benefits compared with routine care and, in some cases, other interventions. Larger, methodologically improved trials are now recommended to evaluate the benefits of mindfulness therapies further. Introduction A growing number of mindfulness interventions are being used with individuals with psychosis. These therapies employ elements of acceptance and compassion in addition to mindfulness. A number of randomized controlled trials (RCTs) of these interventions have emerged in recent years, but no review of these latest trials exists. Question 'For individuals with psychosis, are mindfulness interventions more effective than treatment as usual or an alternative intervention, in improving patient-related outcomes as demonstrated in RCTs?' Method We undertook a systematic review of randomized controlled studies of mindfulness interventions for psychosis and schizophrenia (MIps). Studies were identified by searching the databases Medline, Embase, PsycINFO, Cochrane Central Register of Controlled Trials, and Allied and Complementary Medicine. Findings The review identified 11 RCTs investigating eight mindfulness interventions. Significant improvements were reported on a number of measures, although gains were mostly smaller in trials employing well-designed controls and where assessors were blind to treatment allocation. There was considerable heterogeneity amongst trials in the diversity of treatments reviewed and the range of outcomes assessed. Implications for Practice The findings suggest MIps are feasible for individuals with psychosis and provide a number of significant benefits over routine care and, in some cases, other interventions. © 2016 John Wiley & Sons Ltd.

How to study the aetiology of burn injury: the epidemiological approach.

PubMed

Bouter, L M; Knipschild, P G; van Rijn, J L; Meertens, R M

1989-06-01

Effective prevention of burn injury should be based on sound aetiological knowledge. This article deals with epidemiological methods to study the incidence of burn injury as a function of its risk factors. Central methodological issues are comparability of baseline prognosis, comparability of measurements (of effects in cohort studies and of risk factors in case-control studies), and comparability of external circumstances. These principles are clarified with a number of fictitious examples of risk factors for burn injury. It is explained that in preventive trials comparability may be achieved by randomization, blinding and placebo intervention. The main tools in non-experimental studies are deliberate selection and multivariate analysis. Special attention is given to the definition of the source population and to reducing measurement incomparability in case-control studies. Some well-designed case-control studies following these principles might bring effective prevention of burn injury some steps nearer.

Vitamin A serostatus and heterosexual transmission of HIV: case-control study in Tanzania and review of the evidence.

PubMed

Villamor, Eduardo; Kapiga, Saidi H; Fawzi, Wafaie W

2006-03-01

Results from a randomized clinical trial suggested that vitamin A/beta-carotene supplementation to HIV-1-infected women during pregnancy and lactation may increase the risk of vertical transmission. Limited information is available on the potential role of vitamin A on heterosexual HIV transmission. This is a relevant question in many resource-limited settings where both vitamin A deficiency and HIV infection are highly prevalent. We conducted a case-control study (34 cases and 38 controls) nested within a cohort of HIV-negative women attending family planning clinics in Tanzania, to examine whether low serum concentrations at baseline were associated with the risk of seroconversion. There was not a significant association (OR = 2.14, 95% C I = 0.54, 8.45). In light of these and previous results, we conclude that there is not enough evidence yet to suggest a causal association between vitamin A and heterosexual transmission.

The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) Study Protocol

PubMed Central

Woo, Daniel; Rosand, Jonathan; Kidwell, Chelsea; McCauley, Jacob L.; Osborne, Jennifer; Brown, Mark W.; West, Sandra E.; Rademacher, Eric W.; Waddy, Salina; Roberts, Jamie N.; Koch, Sebastian; Gonzales, Nicole R.; Sung, Gene; Kittner, Steven J.; Birnbaum, Lee; Frankel, Michael; Daniel Testai, Fernando; Hall, Christiana E.; Elkind, Mitchell S. V.; Flaherty, Matthew; Coull, Bruce; Chong, Ji Y.; Warwick, Tanya; Malkoff, Marc; James, Michael L.; Ali, Latisha K.; Worrall, Bradford B.; Jones, Floyd; Watson, Tiffany; Leonard, Anne; Martinez, Rebecca; Sacco, Ralph I; Langefeld, Carl D.

2013-01-01

Background and Purpose Epidemiologic studies of intracerebral hemorrhage (ICH) have consistently demonstrated variation in incidence, location, age at presentation, and outcomes among non-Hispanic white, black, and Hispanic populations. We report here the design and methods for this large, prospective, multi-center case-control study of ICH. Methods The ERICH study is a multi-center, prospective case-control study of ICH. Cases are identified by hot-pursuit and enrolled using standard phenotype and risk factor information and include neuroimaging and blood sample collection. Controls are centrally identified by random digit dialing to match cases by age (+/−5 years), race, ethnicity, gender and metropolitan region. Results As of March 22, 2013, 1,655 cases of ICH had been recruited into the study which is 101.5% of the target for that date and 851 controls had been recruited which is 67.2% of the target for that date (1,267 controls) for a total of 2,506 subjects which is 86.5% of the target for that date (2,897 subjects). Of the 1,655 cases enrolled, 1,640 cases had the case interview entered into the database of which 628 (38%) were non-Hispanic black, 458 (28%) were non-Hispanic white and 554 (34%) were Hispanic. Of the 1,197 cases with imaging submitted, 876 (73.2%) had a 24 hour follow-up CT available In addition to CT imaging, 607 cases have had MRI evaluation. Conclusion The ERICH study is a large, case-control study of ICH with particular emphasis on recruitment of minority populations for the identification of genetic and epidemiologic risk factors for ICH and outcomes after ICH. PMID:24021679

Performance of time-varying predictors in multilevel models under an assumption of fixed or random effects.

PubMed

Baird, Rachel; Maxwell, Scott E

2016-06-01

Time-varying predictors in multilevel models are a useful tool for longitudinal research, whether they are the research variable of interest or they are controlling for variance to allow greater power for other variables. However, standard recommendations to fix the effect of time-varying predictors may make an assumption that is unlikely to hold in reality and may influence results. A simulation study illustrates that treating the time-varying predictor as fixed may allow analyses to converge, but the analyses have poor coverage of the true fixed effect when the time-varying predictor has a random effect in reality. A second simulation study shows that treating the time-varying predictor as random may have poor convergence, except when allowing negative variance estimates. Although negative variance estimates are uninterpretable, results of the simulation show that estimates of the fixed effect of the time-varying predictor are as accurate for these cases as for cases with positive variance estimates, and that treating the time-varying predictor as random and allowing negative variance estimates performs well whether the time-varying predictor is fixed or random in reality. Because of the difficulty of interpreting negative variance estimates, 2 procedures are suggested for selection between fixed-effect and random-effect models: comparing between fixed-effect and constrained random-effect models with a likelihood ratio test or fitting a fixed-effect model when an unconstrained random-effect model produces negative variance estimates. The performance of these 2 procedures is compared. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Indoor dampness and molds and development of adult-onset asthma: a population-based incident case-control study.

PubMed Central

Jaakkola, Maritta S; Nordman, Henrik; Piipari, Ritva; Uitti, Jukka; Laitinen, Jukka; Karjalainen, Antti; Hahtola, Paula; Jaakkola, Jouni J K

2002-01-01

Previous cross-sectional and prevalent case-control studies have suggested increased risk of asthma in adults related to dampness problems and molds in homes. We conducted a population-based incident case-control study to assess the effects of indoor dampness problems and molds at work and at home on development of asthma in adults. We recruited systematically all new cases of asthma during a 2.5-year study period (1997-2000) and randomly selected controls from a source population consisting of adults 21-63 years old living in the Pirkanmaa Hospital district, South Finland. The clinically diagnosed case series consisted of 521 adults with newly diagnosed asthma and the control series of 932 controls, after we excluded 76 (7.5%) controls with a history of asthma. In logistic regression analysis adjusting for confounders, the risk of asthma was related to the presence of visible mold and/or mold odor in the workplace (odds ratio, 1.54; 95% confidence interval, 1.01-2.32) but not to water damage or damp stains alone. We estimated the fraction of asthma attributable to workplace mold exposure to be 35.1% (95% confidence interval, 1.0-56.9%) among the exposed. Present results provide new evidence of the relation between workplace exposure to indoor molds and adult-onset asthma. PMID:12003761

Cultural participation and health: a randomized controlled trial among medical care staff.

PubMed

Bygren, Lars Olov; Weissglas, Gösta; Wikström, Britt-Maj; Konlaan, Boinkum Benson; Grjibovski, Andrej; Karlsson, Ann-Brith; Andersson, Sven-Olof; Sjöström, Michael

2009-05-01

Population studies demonstrate that attending cultural events is conducive to improved health when baseline health, income, education, and health habits are taken into account. Animal experiments suggest possible mechanisms. We studied the link in humans between attending cultural events and health in a randomized controlled trial. Members of the local government officers' union in the health services in Umeå, Sweden, were invited to the experiment and 101 people registered for fine arts visits once a week for 8 weeks. They chose films, concerts, or art exhibitions visits, or singing in a choir and were then randomized into 51 cases, starting at once, and 50 controls starting after the trial. Health was assessed before randomization and after the experimental period using the instrument for perceived health, short form (SF)-36, and tests of episodic memory, saliva-cortisol and immunoglobulin. The results were analyzed using a mixed design analysis of variance. The SF-36 Composite Score called physical health improved in the intervention group and decreased among controls during the experiment (F(1,87) = 7.06, p = .009). The individual factor of the SF-36 called social functioning, improved more in the intervention group than among controls (F(1,98) = 8.11, p = .005) as well as the factor vitality (F(1,98) = 5.26, p = .024). The six other factors and the Mental Health Composite Score, episodic memory, cortisol and immunoglobulin levels did not change otherwise than among controls. Mechanisms are left to be identified. Fine arts stimulations improved perceived physical health, social functioning, and vitality.

An empirically derived dietary pattern associated with breast cancer risk is validated in a nested case-control cohort from a randomized primary prevention trial.

PubMed

Hidaka, Brandon H; Kimler, Bruce F; Fabian, Carol J; Carlson, Susan E

2017-02-01

We reported an association between cytologic atypia, a reversible biomarker of breast cancer risk, and lower omega-3/omega-6 fatty acid ratio in blood and breast tissue. Our goal was to develop and validate a dietary pattern index in this high-risk sample of U.S. women, and test its capacity to predict incidence in a nested case-control cohort of Canadian women from a randomized trial of a low-fat dietary intervention for primary prevention of breast cancer. Food intake was measured by food frequency questionnaire in the U.S. sample (n = 65) and multiple dietary recalls in the Canadian sample (n = 220 cases; 440 controls). Principal component analysis identified a dietary pattern associated with atypia. We measured differences among dietary pattern tertiles in (a) fatty acid composition in blood lipids and breast tissue in the U.S. sample, and (b) risk of breast cancer subtypes in the Canadian cohort. Registered under ClinicalTrials.gov Identifier: NCT00148057. A Modern diet was characterized as consuming more grains, dairy, and sugar and less vegetables, fish and poultry; these women had lower tissue omega-3 fatty acids and higher omega-6 and trans fatty acids. The low-fat intervention increased the likelihood of a Modern diet after randomization. A Modern diet at baseline and post-randomization was associated with estrogen-receptor negative (ER-) breast cancer risk among those at least 160 cm tall. A Traditional diet (the reciprocal of Modern) at baseline was associated with lower ER-positive (ER+) risk in the comparison group, but not the low-fat intervention group. A Modern diet (high in grains, dairy, and sugar and low in vegetables, fish, and poultry) is associated with ER- breast cancer risk among taller women. Recommending dietary fat reduction may have untoward effects on breast cancer risk. Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

Validity and reliability of chronic tic disorder and obsessive-compulsive disorder diagnoses in the Swedish National Patient Register.

PubMed

Rück, Christian; Larsson, K Johan; Lind, Kristina; Perez-Vigil, Ana; Isomura, Kayoko; Sariaslan, Amir; Lichtenstein, Paul; Mataix-Cols, David

2015-06-22

The usefulness of cases diagnosed in administrative registers for research purposes is dependent on diagnostic validity. This study aimed to investigate the validity and inter-rater reliability of recorded diagnoses of tic disorders and obsessive-compulsive disorder (OCD) in the Swedish National Patient Register (NPR). Chart review of randomly selected register cases and controls. 100 tic disorder cases and 100 OCD cases were randomly selected from the NPR based on codes from the International Classification of Diseases (ICD) 8th, 9th and 10th editions, together with 50 epilepsy and 50 depression control cases. The obtained psychiatric records were blindly assessed by 2 senior psychiatrists according to the criteria of the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and ICD-10. Positive predictive value (PPV; cases diagnosed correctly divided by the sum of true positives and false positives). Between 1969 and 2009, the NPR included 7286 tic disorder and 24,757 OCD cases. The vast majority (91.3% of tic cases and 80.1% of OCD cases) are coded with the most recent ICD version (ICD-10). For tic disorders, the PPV was high across all ICD versions (PPV=89% in ICD-8, 86% in ICD-9 and 97% in ICD-10). For OCD, only ICD-10 codes had high validity (PPV=91-96%). None of the epilepsy or depression control cases were wrongly diagnosed as having tic disorders or OCD, respectively. Inter-rater reliability was outstanding for both tic disorders (κ=1) and OCD (κ=0.98). The validity and reliability of ICD codes for tic disorders and OCD in the Swedish NPR is generally high. We propose simple algorithms to further increase the confidence in the validity of these codes for epidemiological research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Environmental adversities and psychotic symptoms: The impact of timing of trauma, abuse, and neglect.

PubMed

Schalinski, Inga; Breinlinger, Susanne; Hirt, Vanessa; Teicher, Martin H; Odenwald, Michael; Rockstroh, Brigitte

2017-11-13

Trauma and adverse childhood experiences (ACE) occur more often in mental illness, including psychosis, than in the general population. Individuals with psychosis (cases) report a higher number and severity (dose) of adversities than healthy controls. While a dose-dependent increase of adversities has been related to more severe psychopathology, the role of type and timing is still insufficiently understood on the exacerbation of positive and negative psychotic symptoms. Moreover, dissociative symptoms were examined as potential mediator between adversities and severity of psychotic symptoms. Exposure to adversities were assessed by interviews in n=180 cases and n=70 controls. In cases, symptom severities were obtained for psychotic symptoms and dissociation. Conditioned random forest regression determined the importance of type and timing of ACE for positive and negative symptom severity, and mediator analyses evaluated the role of dissociative symptoms in the relationship between adversities and psychotic symptoms. Cases experienced substantially more abuse and neglect than controls. Adversities were related in a dose-dependent manner to psychotic disorder. An array of adversities was associated with more severe positive symptoms, while the conditioned random forest regression depicted neglect at age 10 as the most important predictor. Dissociative symptoms mediated the small relation of trauma load in childhood and positive symptoms. The role of trauma and ACE on psychotic symptoms can be specified by neglect during frontocortical development in the exacerbation of positive symptoms. The mediating role of dissociation is restricted to the relation of childhood trauma and positive symptoms. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of boron supplementation on the severity and duration of pain in primary dysmenorrhea.

PubMed

Nikkhah, Somayeh; Dolatian, Mahrokh; Naghii, Mohammad Reza; Zaeri, Farid; Taheri, Seyed Mojtaba

2015-05-01

Primary dysmenorrhea refers to painful menstrual cramps without pelvic pathology. The condition is highly prevalent among women and exerts negative effects on their quality of life. Considering the evidence for anti-inflammatory properties of Boron, the present study aimed to determine the effects of Boron supplementation on the severity and duration of menstrual pain in female university students. This triple-blind randomized clinical trial study recruited 113 university students. The participants were matched for the severity and duration of dysmenorrhea and randomly allocated into the case and control groups (n = 58 and 55, respectively). The case group consumed 10 mg/day Boron from two days before the menstrual flow until its third day. The control group received placebo capsules (similar to those distributed among the cases). All subjects were asked to take the capsules for two consecutive menstrual cycles. Pain severity (measured on a visual analog scale) and duration (in hours) were measured at baseline and during the two cycles. The two groups had no significant differences in the severity and duration of pain at baseline. After the intervention, however, the severity and duration of pain were significantly lower in the case group than in the control group (P < 0.05). Based on our findings, Boron supplementation can reduce the severity and duration of menstrual pain through exerting anti-inflammatory effects. In order to clarify the effects of Boron on dysmenorrhea, future studies are required to measure the levels of hormones and inflammatory biomarkers. Copyright © 2015 Elsevier Ltd. All rights reserved.

A food-borne outbreak of gastroenteritis caused by different Salmonella serotypes in 2 universities in Xiamen, Fujian, China, in 2012.

PubMed

Guo, Zhinan; Su, Cheng hao; Huang, Jianwei; Niu, JianJun

2015-01-01

We investigated a diarrhea outbreak in 2 universities to identify the etiological agent responsible, the source of infection, the mode of transmission, and the risk factors. A case-controlled study was conducted using case students and asymptomatic control students who were selected randomly and frequency-matched according to class and age, and the source of food or water intake was investigated. Of the total 22,404 students at the universities, 0.25% developed Salmonella Infections. A total of 96% (54/56) of the case students and 30% (35/117) of the control students consumed bread products provided by the same vendor (odds ratio [OR] = 63.3; 95% confidence interval [CI], 14.9-550.7). Among the students who consumed bread, 96% (52/54) of the case students and 9% (3/35) of the control students ate egg sandwiches (OR = 277.3; 95%CI, 43.9-1,750.8). Seven strains of Salmonella enteritidis and 6 strains of S. chester were isolated from the case students or food samples. Pulsed-field gel electrophoresis typing showed the same patterns. The outbreak of gastroenteritis was caused mainly by egg sandwiches contaminated with different serotypes of Salmonella.

Shigellosis outbreak associated with contaminated well water in a rural elementary school: Sichuan Province, China, June 7-16, 2009.

PubMed

He, Fan; Han, Ke; Liu, Lunguang; Sun, Wei; Zhang, Lijie; Zhu, Baoping; Ma, Huilai

2012-01-01

We investigated a shigellosis outbreak in an elementary school to identify the source of infection, mode of transmission and risk factors for illness. In a case-control investigation, we compared the source of drinking water, consumption of untreated well water and suspected food items, and hygienic habits between case-students and randomly selected asymptomatic control-students, frequency-matched by class on a 1:1 ratio. 18% of the 533 students and no teachers developed Shigella. 52%(44/85) of case-students and 17% (12/71) of control-students drank untreated well water (OR = 2.3, 95% CI = 1.1-5.8); 47% (n = 40/85) of case-students and 14% (10/71) of control-students drank untreated water from Well A (OR = 3.7, 95% CI = 1.3-11). The odds ratio increased with the amount of untreated Well A water consumed (p = 0.035, χ(2) test for trend). Rectal swabs from 5 of 6 case-students and water from Well A yielded Shigella flexneri 2b. This shigellosis outbreak was caused by drinking untreated water from a well polluted by Shigella flexneri 2b.

Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial.

PubMed

Merle, B; Chapurlat, R; Vignot, E; Thomas, T; Haesebaert, J; Schott, A-M

2017-05-01

We conducted a multicenter, randomized controlled trial to evaluate the impact of a population-based patient-centered post-fracture care program with a dedicated case manager, PREVention of OSTeoporosis (PREVOST), on appropriate post-fracture osteoporosis management. We showed that, compared to usual care, BMD investigation post-fracture was significantly improved (+20%) by our intervention program. Our study aims to evaluate the impact of a population-based patient-centered post-fracture care program, PREVOST, on appropriate post-fracture care. Multicenter, randomized controlled trial enrolling 436 women aged 50 to 85 years and attending a French hospital, for a low-energy fracture of the wrist or humerus. Randomization was stratified by age, hospital department, and site of fracture. The intervention was performed by a trained case manager who interacted only with the patients, with repeated oral and written information about fragility fractures and osteoporosis management, and prompting them to visit their primary care physicians. Control group received usual care. The primary outcome was the initiation of an appropriate post-fracture care defined by Bone Mineral Density (BMD) and/or anti-osteoporotic treatment prescription at 6 months. At 6 months, 53% of women in intervention group initiated a post-fracture care versus 33% for usual care (adjOR 2.35, 95%CI [1.58-3.50], p < 0.001). Post-fracture care was more frequent after wrist than humerus fracture (adjOR 1.93, 95%CI [1.14-3.30], p = 0.015) and decreased with age (adjOR for 10 years increase 0.76, 95%CI [0.61-0.96], p = 0.02). The intervention resulted in BMD prescription in 50% of patients (adjOR 2.10, 95%CI [1.41-3.11], p < 0.001) and in BMD performance in 41% of patients (adjOR 2.12, 95%CI [1.40-3.20], p < 0.001) versus 33 and 25% for usual care, respectively. Having performed a BMD increased treatment prescription; however, only 46% of women with a low BMD requiring a treatment according to the French guidelines received a prescription. A patient-centered care program with a dedicated case manager can significantly improve post-fracture BMD investigation.

[Psychoprophylaxis in elective paediatric general surgery: does audiovisual tools improve the perioperative anxiety in children and their families?

PubMed

Álvarez García, N; Gómez Palacio, V; Siles Hinojosa, A; Gracia Romero, J

2017-10-25

Surgery is considered a stressful experience for children and their families who undergo elective procedures. Different tools have been developed to improve perioperative anxiety. Our objective is to demonstrate if the audiovisual psychoprophylaxis reduces anxiety linked to paediatric surgery. A randomized prospective case-control study was carried out in children aged 4-15 who underwent surgery in a Paediatric Surgery Department. We excluded patients with surgical backgrounds, sever illness or non-elective procedures. Simple randomization was performed and cases watched a video before being admitted, under medical supervision. Trait and state anxiety levels were measured using the STAI-Y2, STAI-Y2, STAI-C tests and VAS in children under 6-years-old, at admission and discharge. 100 patients (50 cases/50 controls) were included, mean age at diagnosis was 7.98 and 7.32 respectively. Orchiopexy was the most frequent surgery performed in both groups. Anxiety state levels from parents were lower in the Cases Group (36.06 vs 39.93 p= 0.09 in fathers, 38.78 vs 40.34 p= 0.43 in mothers). At discharge, anxiety levels in children aged > 6 were statistically significant among cases (26.84 vs 32.96, p< 0.05). The use of audiovisual psychoprophylaxis tools shows a clinically relevant improvement in perioperative anxiety, both in children and their parents. Our results are similar to those reported by other authors supporting these tools as beneficial strategy for the family.

Threshold-Based Random Charging Scheme for Decentralized PEV Charging Operation in a Smart Grid.

PubMed

Kwon, Ojin; Kim, Pilkee; Yoon, Yong-Jin

2016-12-26

Smart grids have been introduced to replace conventional power distribution systems without real time monitoring for accommodating the future market penetration of plug-in electric vehicles (PEVs). When a large number of PEVs require simultaneous battery charging, charging coordination techniques have become one of the most critical factors to optimize the PEV charging performance and the conventional distribution system. In this case, considerable computational complexity of a central controller and exchange of real time information among PEVs may occur. To alleviate these problems, a novel threshold-based random charging (TBRC) operation for a decentralized charging system is proposed. Using PEV charging thresholds and random access rates, the PEVs themselves can participate in the charging requests. As PEVs with a high battery state do not transmit the charging requests to the central controller, the complexity of the central controller decreases due to the reduction of the charging requests. In addition, both the charging threshold and the random access rate are statistically calculated based on the average of supply power of the PEV charging system that do not require a real time update. By using the proposed TBRC with a tolerable PEV charging degradation, a 51% reduction of the PEV charging requests is achieved.

Threshold-Based Random Charging Scheme for Decentralized PEV Charging Operation in a Smart Grid

PubMed Central

Kwon, Ojin; Kim, Pilkee; Yoon, Yong-Jin

2016-01-01

Smart grids have been introduced to replace conventional power distribution systems without real time monitoring for accommodating the future market penetration of plug-in electric vehicles (PEVs). When a large number of PEVs require simultaneous battery charging, charging coordination techniques have become one of the most critical factors to optimize the PEV charging performance and the conventional distribution system. In this case, considerable computational complexity of a central controller and exchange of real time information among PEVs may occur. To alleviate these problems, a novel threshold-based random charging (TBRC) operation for a decentralized charging system is proposed. Using PEV charging thresholds and random access rates, the PEVs themselves can participate in the charging requests. As PEVs with a high battery state do not transmit the charging requests to the central controller, the complexity of the central controller decreases due to the reduction of the charging requests. In addition, both the charging threshold and the random access rate are statistically calculated based on the average of supply power of the PEV charging system that do not require a real time update. By using the proposed TBRC with a tolerable PEV charging degradation, a 51% reduction of the PEV charging requests is achieved. PMID:28035963

Association between dietary fiber and endometrial cancer: a dose-response meta-analysis123

PubMed Central

Bandera, Elisa V; Kushi, Lawrence H; Moore, Dirk F; Gifkins, Dina M; McCullough, Marjorie L

2008-01-01

Background Endometrial cancer is the most common female gynecologic cancer in the United States. Excessive and prolonged exposure of the endometrium to estrogens unopposed by progesterone and a high body mass are well-established risk factors for endometrial cancer. Although dietary fiber has been shown to beneficially reduce estrogen concentrations and prevent obesity, its role in endometrial cancer has received relatively little attention. Objective The objective was to summarize and quantify the current evidence of a role of dietary fiber consumption in endometrial cancer risk and to identify research gaps in this field. Design We conducted a systematic literature review of articles published through February 2007 to summarize the current evidence of a relation between dietary fiber consumption and endometrial cancer risk and to quantify the magnitude of the association by conducting a dose-response meta-analysis. Results Ten articles representing 1 case-cohort study and 9 case-control studies that evaluated several aspects of fiber consumption and endometrial cancer risk were identified through searches in various databases. On the basis of 7 case-control studies, the random-effects summary risk estimate was 0.82 (95% CI: 0.75, 0.90) per 5 g/1000 kcal dietary fiber, with no evidence of heterogeneity (I2: 0%, P for heterogeneity: 0.55). The random-effects summary estimate was 0.71 (95% CI: 0.59, 0.85) for the comparison of the highest with the lowest dietary fiber intake in 8 case-control studies, with little evidence of heterogeneity (I2: 20.8%, P for heterogeneity: 0.26). In contrast, the only prospective study that evaluated this association did not find an association. Conclusions Although the current evidence, based on data from case-control studies, supports an inverse association between dietary fiber and endometrial cancer, additional population-based studies, particularly cohort studies, are needed before definitive conclusions can be drawn. PMID:18065593

An Evaluation of Mass Screening Using Fecal Occult Blood Test for Colorectal Cancer in Japan: A Case‐Control Study

PubMed Central

Hiwatashi, Nobuo; Morimoto, Tomizo; Fukao, Akira; Sato, Hirofusa; Sugahara, Nobuyuki; Hisamichi, Shigeru; Toyota, Takayoshi

1993-01-01

There is as yet no firm evidence showing that mass screening for colorectal cancer using fecal occult blood tests (FOBTs) reduces the mortality from this cancer. Therefore we evaluated the effectiveness of the screening by a case‐control study in Miyagi Prefecture, Japan. The study included as case subjects 28 individuals who had died from colorectal cancer and had had an opportunity to participate in the mass screening before the date of diagnosis as colorectal cancer, and 3 controls for each case subject randomly selected from residents who were alive on the date of death of case subjects and matched by sex, age (within 3 years) and living area using residential files. For each set, i.e., a case subject and 3 controls, screening histories before the date of the diagnosis of the case as colorectal cancer were examined. Both the case subjects and the controls who had participated in the screening at least once within 3 years before the date of diagnosis of the case were classified as “screened.” The 28 case subjects consisted of 12 males and 16 females (average age: 60.8 years). The odds ratio of death from colorectal cancer for the screened versus the non‐screened persons was 0.24 (95% confidence interval = 0.08–0.76) by the Mantel‐Haenszel method. The present study suggests that mass screening using FOBTs for colorectal cancer significantly reduces the mortality from this cancer epidemiologically. PMID:8276715

Case−Control Study of Risk Factors for Meningococcal Disease in Chile

PubMed Central

Matute, Isabel; González, Claudia; Delgado, Iris; Poffald, Lucy; Pedroni, Elena; Alfaro, Tania; Hirmas, Macarena; Nájera, Manuel; Gormaz, Ana; López, Darío; Loayza, Sergio; Ferreccio, Catterina; Gallegos, Doris; Fuentes, Rodrigo; Vial, Pablo; Aguilera, Ximena

2017-01-01

An outbreak of meningococcal disease with a case-fatality rate of 30% and caused by predominantly serogroup W of Neisseria meningitidis began in Chile in 2012. This outbreak required a case−control study to assess determinants and risk factors for infection. We identified confirmed cases during January 2012−March 2013 and selected controls by random sampling of the population, matched for age and sex, resulting in 135 case-patients and 618 controls. Sociodemographic variables, habits, and previous illnesses were studied. Analyses yielded adjusted odds ratios as estimators of the probability of disease development. Results indicated that conditions of social vulnerability, such as low income and overcrowding, as well as familial history of this disease and clinical histories, especially chronic diseases and hospitalization for respiratory conditions, increased the probability of illness. Findings should contribute to direction of intersectoral public policies toward a highly vulnerable social group to enable them to improve their living conditions and health. PMID:28628448

Intraoperative Comparison of Anatomical versus Round Implants in Breast Augmentation: A Randomized Controlled Trial.

PubMed

Hidalgo, David A; Weinstein, Andrew L

2017-03-01

The purpose of this randomized controlled trial was to determine whether anatomical implants are aesthetically superior to round implants in breast augmentation. Seventy-five patients undergoing primary breast augmentation had a round silicone implant of optimal volume, projection, and diameter placed in one breast and an anatomical silicone device of similar volume and optimal shape placed in the other. After intraoperative photographs were taken, the anatomical device was replaced by a round implant to complete the procedure. A survey designed to measure breast aesthetics was administered to 10 plastic surgeon and 10 lay reviewers for blind evaluation of the 75 cases. No observable difference in breast aesthetics between anatomical and round implants was reported by plastic surgeons in 43.6 percent or by lay individuals in 29.2 percent of cases. When a difference was perceived, neither plastic surgeons nor lay individuals preferred the anatomical side more often than the round side. Plastic surgeons judged the anatomical side superior in 51.1 percent of cases and the round side superior in 48.9 percent of cases (p = 0.496). Lay individuals judged the anatomical side superior in 46.7 percent of cases and the round side superior in 53.3 percent (p = 0.140). Plastic surgeons identified implant shape correctly in only 26.5 percent of cases. This study provides high-level evidence supporting no aesthetic superiority of anatomical over round implants. Given that anatomical implants have important and unique disadvantages, a lack of proven aesthetic superiority argues against their continued use in breast augmentation. Therapeutic, I.

Intestinal virome changes precede autoimmunity in type I diabetes-susceptible children

PubMed Central

Vatanen, Tommi; Droit, Lindsay; Kostic, Aleksandar D.; Poon, Tiffany W.; Vlamakis, Hera; Siljander, Heli; Härkönen, Taina; Hämäläinen, Anu-Maaria; Peet, Aleksandr; Tillmann, Vallo; Ilonen, Jorma; Wang, David; Knip, Mikael; Xavier, Ramnik J.

2017-01-01

Viruses have long been considered potential triggers of autoimmune diseases. Here we defined the intestinal virome from birth to the development of autoimmunity in children at risk for type 1 diabetes (T1D). A total of 220 virus-enriched preparations from serially collected fecal samples from 11 children (cases) who developed serum autoantibodies associated with T1D (of whom five developed clinical T1D) were compared with samples from controls. Intestinal viromes of case subjects were less diverse than those of controls. Among eukaryotic viruses, we identified significant enrichment of Circoviridae-related sequences in samples from controls in comparison with cases. Enterovirus, kobuvirus, parechovirus, parvovirus, and rotavirus sequences were frequently detected but were not associated with autoimmunity. For bacteriophages, we found higher Shannon diversity and richness in controls compared with cases and observed that changes in the intestinal virome over time differed between cases and controls. Using Random Forests analysis, we identified disease-associated viral bacteriophage contigs after subtraction of age-associated contigs. These disease-associated contigs were statistically linked to specific components of the bacterial microbiome. Thus, changes in the intestinal virome preceded autoimmunity in this cohort. Specific components of the virome were both directly and inversely associated with the development of human autoimmune disease. PMID:28696303

Opportunistic detection of atrial fibrillation in subjects aged 65 years or older in primare care: a randomised clinical trial of efficacy. DOFA-AP study protocol.

PubMed

Pérula-de-Torres, Luis Á; Martínez-Adell, Miguel Á; González-Blanco, Virginia; Baena-Díez, José M; Martín-Rioboó, Enrique; Parras-Rejano, Juan M; González-Lama, Jesús; Martín-Alvarez, Remedios; Ruiz-Moral, Roger; Fernández-García, José Á; Pérez-Díaz, Modesto; Ruiz-de-Castroviejo, Joaquin; Pérula-de-Torres, Carlos; Valero-Martín, Antonio; Roldán-Villalobos, Ana; Criado-Larumbe, Margarita; Burdoy-Joaquín, Emili; Coma-Solé, Montserrat; Cervera-León, Mercè; Cuixart-Costa, Lluís

2012-10-30

Clinical Practice Guidelines recommend using peripheral blood pulse measuring as a screening test for Atrial Fibrillation. However, there is no adequate evidence supporting the efficacy of such procedure in primary care clinical practice. This paper describes a study protocol designed to verify whether early opportunistic screening for Atrial Fibrillation by measuring blood pulse is more effective than regular practice in subjects aged 65 years attending primary care centers. An cluster-randomized controlled trial conducted in Primary Care Centers of the Spanish National Health Service. A total of 269 physicians and nurses will be allocated to one of the two arms of the trial by stratified randomization with a 3:2 ratio (three practitioners will be assigned to the Control Group for every two practitioners assigned to the Experimental Group). As many as 12 870 patients aged 65 years or older and meeting eligibility criteria will be recruited (8 580 will be allocated to the Experimental Group and 4 290 to the Control Group). Randomization and allocation to trial groups will be carried out by a central computer system. The Experimental Group practitioners will conduct an opportunistic case finding for patients with Atrial Fibrillation, while the Control Group practitioners will follow the regular guidelines. The first step will be finding new Atrial Fibrillation cases. A descriptive inferential analysis will be performed (bivariate and multivariate by multilevel logistic regression analysis). If our hypothesis is confirmed, we expect Primary Care professionals to take a more proactive approach and adopt a new protocol when a patient meeting the established screening criteria is identified. Finally, we expect this measure to be incorporated into Clinical Practice Guidelines. The study is registered as NCT01291953 (ClinicalTrials.gob).

The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Gary, Tiffany L; Batts-Turner, Marian; Yeh, Hsin-Chieh; Hill-Briggs, Felicia; Bone, Lee R; Wang, Nae-Yuh; Levine, David M; Powe, Neil R; Saudek, Christopher D; Hill, Martha N; McGuire, Maura; Brancati, Frederick L

2009-10-26

Although African American adults bear a disproportionate burden from diabetes mellitus (DM), few randomized controlled trials have tested culturally appropriate interventions to improve DM care. We randomly assigned 542 African Americans with type 2 DM enrolled in an urban managed care organization to either an intensive or minimal intervention group. The intensive intervention group consisted of all components of the minimal intervention plus individualized, culturally tailored care provided by a nurse case manager (NCM) and a community health worker (CHW), using evidence-based clinical algorithms with feedback to primary care providers (eg, physicians, nurse practitioners, or physician assistants). The minimal intervention consisted of mailings and telephone calls every 6 months to remind participants about preventive screenings. Data on diabetic control were collected at baseline and at 24 months by blind observers; data emergency department (ER) visits and hospitalizations were assessed using administrative data. At baseline, participants had a mean age of 58 years, 73% were women, and 50% were living in poverty. At 24 months, compared with the minimal intervention group, those in the intensive intervention group were 23% less likely to have ER visits (rate difference [RD], -14.5; adjusted rate ratio [RR], 0.77; 95% confidence interval [CI], 0.59-1.00). In on-treatment analyses, the rate reduction was strongest for patients who received the most NCM and CHW visits (RD, -31.0; adjusted RR, 0.66; 95% CI, 0.43-1.00; rate reduction downward arrow 34%). These data suggest that a culturally tailored intervention conducted by an NCM/CHW team reduced ER visits in urban African Americans with type 2 DM. clinicaltrials.gov Identifier: NCT00022750.

Concerns About Lung Cancer Among Prisoners.

PubMed

Renault, Luc; Perrot, Emmanuel; Pradat, Eric; Bartoli, Christophe; Greillier, Laurent; Remacle-Bonnet, Anne; Telmon, Norbert; Mazières, Julien; Molinier, Laurent; Couraud, Sébastien

2018-02-01

Few studies have looked at lung cancer in prisoners, despite this population is possibly at increased risk of malignancy. In a previous study, we found an early onset of lung cancer in prisoners. Thus, the present CARCAN study was aimed at assessing the epidemiological characteristics, management, prognosis, and incidence of lung cancer in prisoners compared to a sample of non-prisoner patients. We performed a multi-center observational case-control study. Cases were prisoners diagnosed with lung cancer from 2005 to 2013. Controls were non-prisoner lung cancer patients selected from hospital databases and randomly matched to cases (targeted case-control ratio: 1:3). Incidence rates in both groups were calculated using national statistics. Seventy-two cases and 170 controls met inclusion criteria. Cases were mainly men (99%). Mean age at diagnosis was 52.9 (± 11.0) in cases and 64.3 (± 10.1) in controls (p < 0.0001). More case patients were current smokers compared to control patients (83% vs 53%; p < 0.0001). We found no significant differences between the two groups as concerns histologic types, TNM stages at diagnosis, initially-employed treatments, times to management or survival. Incidence rates (2008-2012) in male prisoners were higher than those in the general population in all concerned age groups. There is a shift of lung cancer toward young people in prisons. However, the presentation, management, and prognosis of lung cancer are similar between prisoners and non-prisoners. These finding could justify a specific screening policy for the incarcerated populations.

[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

PubMed

Lu, Quan

2010-03-01

To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

Association of diabetes and diabetes treatment with incidence of breast cancer.

PubMed

García-Esquinas, Esther; Guinó, Elisabeth; Castaño-Vinyals, Gemma; Pérez-Gómez, Beatriz; Llorca, Javier; Altzibar, Jone M; Peiró-Pérez, Rosana; Martín, Vicente; Moreno-Iribas, Concepción; Tardón, Adonina; Caballero, Francisco Javier; Puig-Vives, Montse; Guevara, Marcela; Villa, Tania Fernández; Salas, Dolores; Amiano, Pilar; Dierssen-Sotos, Trinidad; Pastor-Barriuso, Roberto; Sala, María; Kogevinas, Manolis; Aragonés, Nuria; Moreno, Víctor; Pollán, Marina

2016-02-01

The aim of this study was to evaluate the association of diabetes and diabetes treatment with risk of postmenopausal breast cancer. Histologically confirmed incident cases of postmenopausal breast (N = 916) cancer were recruited from 23 Spanish public hospitals. Population-based controls (N = 1094) were randomly selected from primary care center lists within the catchment areas of the participant hospitals. ORs (95 % CI) were estimated using mixed-effects logistic regression models, using the recruitment center as a random effect term. Breast tumors were classified into hormone receptor positive (ER+ or PR+), HER2+ and triple negative (TN). Diabetes was not associated with the overall risk of breast cancer (OR 1.09; 95 % CI 0.82-1.45), and it was only linked to the risk of developing TN tumors: Among 91 women with TN tumors, 18.7 % were diabetic, while the corresponding figure among controls was 9.9 % (OR 2.25; 95 % CI 1.22-4.15). Regarding treatment, results showed that insulin use was more prevalent among diabetic cases (2.5 %) as compared to diabetic controls (0.7 %); OR 2.98; 95 % CI 1.26-7.01. They also showed that, among diabetics, the risk of developing HR+/HER2- tumors decreased with longer metformin use (ORper year 0.89; 95 % CI 0.81-0.99; based on 24 cases and 43 controls). This study reinforces the need to correctly classify breast cancers when studying their association with diabetes. Given the low survival rates in women diagnosed with TN breast tumors and the potential impact of diabetes control on breast cancer prevention, more studies are needed to better characterize this association.

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2014-06-01

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

Preventing eating disorders among young elite athletes: a randomized controlled trial.

PubMed

Martinsen, Marianne; Bahr, Roald; Børresen, Runi; Holme, Ingar; Pensgaard, Anne Marte; Sundgot-Borgen, Jorunn

2014-03-01

To examine the effect of a 1-yr school-based intervention program to prevent the development of new cases of eating disorders (ED) and symptoms associated with ED among adolescent female and male elite athletes. All 16 Norwegian Elite Sport High Schools were included (intervention group [n = 9] and control group [n = 7]). In total, 465 (93.8%) first-year student athletes were followed during high school (2008-2011, three school years). The athletes completed the Eating Disorder Inventory 2 and questions related to ED before (pretest), immediately after (posttest 1), and 9 months after the intervention (posttest 2). Clinical interviews (Eating Disorder Examination) were conducted after the pretest (all with symptoms [n = 115, 97%] and a random sample without symptoms [n = 116, 97%]), and at posttest 2, all athletes were interviewed (n = 463, 99.6%). Among females, there were no new cases of ED in the intervention schools, while 13% at the control schools had developed and fulfilled the DSM-IV criteria for ED not otherwise specified (n = 7) or bulimia nervosa (n = 1), P = 0.001. The risk of reporting symptoms was lower in the intervention than in the control schools at posttest 1 (odds ratio [OR] = 0.45, 95% confidence interval [CI] = 0.23-0.89). This effect was attenuated by posttest 2 (OR = 0.57, 95% CI = 0.29-1.09). The intervention showed a relative risk reduction for current dieting (OR = 0.10, 95% CI = 0.02-0.54) and three or more weight loss attempts (OR = 0.47, 95% CI = 0.25-0.90). Among males, there was one new case of ED at posttest 2 (control school) and no difference in the risk of reporting symptoms between groups at posttest 1 or 2. A 1-yr intervention program can prevent new cases of ED and symptoms associated with ED in adolescent female elite athletes.

Risk of stroke in patients with patent foramen ovale: an updated meta-analysis of observational studies.

PubMed

Ma, Bing; Liu, Guangcong; Chen, Xin; Zhang, Jianming; Liu, Yiting; Shi, Jingpu

2014-01-01

Although patent foramen ovale (PFO) is considered to be associated with cryptogenic stroke (CS), there remains an ongoing disputation on this issue because of unstable results from randomized controlled trials. The aim of this study was to reassess the PFO effect on stroke through observational data. An electronic search of PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI) were finished. Only case-control studies and cohort studies in Chinese or English were included in the analysis. Then random-effected meta-analysis models were performed to assess the association between PFO and stroke. Twelve case-control studies and 6 cohort studies were eligible. Case-control studies showed strong association between PFO and CS (odds ratio [OR]: 2.94, 95% confidence interval [CI]: 2.06, 4.20; P < .001), but cohort studies failed to demonstrate a significant association (hazard ratio [HR]: 1.28, 95% CI: .91, 1.80; P = .155). Subgroup analysis revealed that the pooled OR decreased significantly when the region was limited to the United States (OR: 1.52, 95% CI: 1.00, 2.32; P = .083). OR of studies that adjusted major confounders was 1.74 (95% CI: 1.22, 2.47; P = .119) and high-quality studies was 1.68 (95% CI: 1.14, 2.47; P = .072). For cohort studies, a weak statistical association was observed in using transesophageal echocardiography (TEE) studies (HR: 1.45, 95% CI: 1.06, 2.01; P = .138) and follow-up years less than 4 years' studies (HR: 1.45, 95% CI: 1.00, 2.09; P = .064). Although case-control studies still show a positive effect of PFO on stroke, the results of cohort challenged the credibility. Further trial data are needed to confirm the effect of PFO on stroke. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Embedding patient simulation in a pediatric cardiology rotation: a unique opportunity for improving resident education.

PubMed

Mohan, Shaun; Follansbee, Christopher; Nwankwo, Ugonna; Hofkosh, Dena; Sherman, Frederick S; Hamilton, Melinda F

2015-01-01

High-fidelity patient simulation (HFPS) has been used in medical education to bridge gaps in medical knowledge and clinical skills. Few studies have analyzed the impact of HFPS in subspecialty rotations for pediatric residents. We hypothesized that pediatric residents exposed to HFPS with a structured content curriculum would perform better on a case quiz than residents without exposure to HFPS. Prospective randomized controlled Tertiary-care free standing children's hospital During a cardiology rotation, senior pediatric residents completed an online pediatric cardiology curriculum and a cardiology quiz. After randomization into two groups, the study group participated in a fully debriefed HFPS session. The control group had no HFPS. Both groups completed a case quiz. Confidence surveys pre- and postsimulation were completed. From October 2010 through March 2013, 55 residents who rotated through the pediatric cardiology rotation were used in the final analysis (30 control, 25 in the study group). There was no significant difference between groups on the initial cardiology quiz. The study group scored higher on the case quiz compared with the control group (P = .024). Based on pre- and postsimulation questionnaires, residents' confidence in approaching a pediatric cardiology patient improved from an average Likert score of 5.1 to 7.5 (on scale of 0-10) (P < .001). Incorporation of HFPS into a preexisting pediatric cardiology rotation was feasible and well received. Our study suggests that simulation promotes increased confidence and may modestly improve clinical reasoning compared to traditional educational techniques. Targeted simulation sessions may readily be incorporated into pediatric subspecialty rotations. © 2014 Wiley Periodicals, Inc.

Randomized trial of supplementary interviewing techniques to enhance recall of sexual partners in contact interviews.

PubMed

Brewer, Devon D; Potterat, John J; Muth, Stephen Q; Malone, Patricia Z; Montoya, Pamela; Green, David L; Rogers, Helen L; Cox, Patricia A

2005-03-01

People with multiple sex partners tend to forget a significant proportion when recalling them. Randomized trial of supplementary interviewing techniques during routine partner notification contact interviews for chlamydia, gonorrhea, and syphilis in Colorado Springs, CO. Cases with multiple sex partners in the last 3 months (n = 123) participated. Interviewers prompted nonspecifically and read back the list of elicited partners after cases recalled partners on their own. We then randomly assigned cases to receive 1 of 3 sets of recall cues: (1) an experimental set of cues consisting of locations where people meet partners, role relationships, network ties, and first letters of names; (2) another experimental set including common first names; and (3) control cues referring to individual characteristics (e.g., physical appearance). Nonspecific prompting and reading back the list each increased the number of additional partners elicited and located by 3% to 5% on average. On average, the combined location/role/letter/network cues elicited more additional partners (0.57) than did the first-name (0.29) and individual characteristics (0.28) cues. The location and first-name cues were the most effective in eliciting located partners. The supplementary techniques increased the number of new cases found by 12% and, importantly, identified branches of the sexual network that would not otherwise have been discovered. Elicitation of sex partners can be enhanced in contact interviews with simple interviewing techniques, resulting in improved network ascertainment and sexually transmitted disease case finding.

[Therapeutic effect of cervical Jiaji electroacupuncture on postoperative intractable hiccup of liver neoplasms].

PubMed

Zhang, S K; Gao, W B; Liu, Y; He, H

2018-02-23

Objective: To evaluate the therapeutic effect of cervical Jiaji electroacupuncture on postoperative intractable hiccup of liver neoplasms. Methods: A total of 39 patients with postoperative intractable hiccup of liver neoplasms in The First Affiliated Hospital of Heilongjiang University of Chinese Medicine from May 2013 to May 2017 were collected and divided into 2 groups randomly. The electroacupuncture group included 20 cases, the control group included 19 cases. Patients in the electroacupuncture group were treated by cervical Jiaji electroacupuncture (located in C3-5, sympathetic ganglion), while the control group were treated by metoclopramide combined with chlorpromazine for three days. The therapeutic effects of two groups were compared and the onset time were recorded. Results: Total effective rates of electroacupuncture group and control group were 95.0% and 47.4%, respectively. The onset time in electroacupuncture group and control group were (14.8±3.3) h and (30.5±3.1) h, respectively ( P <0.01). Ten cases who resisted the control treatment were then treated by electroacupuncture for 3 days, 6 cases were recovered, 3 cases became better, while 1 case demonstrated no response. No serious adverse reactions were appeared in each group. Conclusion: Cervical Jiaji electroacupuncture is an effective and safe treatment for postoperative intractable hiccup of liver neoplasms, and it can be used as a remedy for intractable hiccup patients who don't respond to drug treatment.

Inverse comorbidity in multiple sclerosis: Findings in a complete nationwide cohort.

PubMed

Thormann, Anja; Koch-Henriksen, Nils; Laursen, Bjarne; Sørensen, Per Soelberg; Magyari, Melinda

2016-11-01

Inverse comorbidity is disease occurring at lower rates than expected among persons with a given index disease. The objective was to identify inverse comorbidity in MS. We performed a combined case-control and cohort study in a total nationwide cohort of cases with clinical onset of MS 1980-2005. We randomly matched each MS-case with five population controls. Comorbidity data were obtained from multiple, independent nationwide registries. Cases and controls were followed from January 1977 to the index date, and from the index date through December 2012. We controlled for false discovery rate and investigated each of eight pre-specified comorbidity categories: psychiatric, cerebrovascular, cardiovascular, lung, and autoimmune comorbidities, diabetes, cancer, and Parkinson's disease. A total of 8947 MS-cases and 44,735 controls were eligible for inclusion. We found no inverse associations with MS before the index date. After the index date, we found a decreased occurrence of chronic lung disease (asthma and chronic obstructive pulmonary disease) (HR 0.80 (95% CI 0.75-0.86, p<0.00025)) and overall cancer (HR 0.88 (95% CI 0.81-0.95, p=0.0005)) among MS-cases. This study showed a decreased risk of cancers and pulmonary diseases after onset of MS. Identification of inverse comorbidity and of its underlying mechanisms may provide important new entry points into the understanding of MS. Copyright © 2016 Elsevier B.V. All rights reserved.

Dietary Cholesterol Intake and Risk of Lung Cancer: A Meta-Analysis.

PubMed

Lin, Xiaojing; Liu, Lingli; Fu, Youyun; Gao, Jing; He, Yunyun; Wu, Yang; Lian, Xuemei

2018-02-08

Multiple epidemiologic studies have evaluated the relationship between dietary cholesterol and lung cancer risk, but the association is controversial and inconclusive. A meta-analysis of case-control studies and cohort studies was conducted to evaluate the relationship between dietary cholesterol intake and lung cancer risk in this study. A relevant literature search up to October 2017 was performed in Web of Science, PubMed, China National Knowledge Infrastructure, Sinomed, and VIP Journal Integration Platform. Ten case-control studies and six cohort studies were included in the meta-analysis, and the risk estimates were pooled using either fixed or random effects models. The case-control studies with a total of 6894 lung cancer cases and 29,736 controls showed that dietary cholesterol intake was positively associated with lung cancer risk (Odds Ratio = 1.70, 95% Confidence Interval: 1.43-2.03). However, there was no evidence of an association between dietary cholesterol intake and risk of lung cancer among the 241,920 participants and 1769 lung cancer cases in the cohort studies (Relative Risk = 1.08, 95% Confidence Interval: 0.94-1.25). Due to inconsistent results from case-control and cohort studies, it is difficult to draw any conclusion regarding the effects of dietary cholesterol intake on lung cancer risk. Carefully designed and well-conducted cohort studies are needed to identify the association between dietary cholesterol and lung cancer risk.

The voluntary-threat approach to control nonpoint source pollution under uncertainty.

PubMed

Li, Youping

2013-11-15

This paper extends the voluntary-threat approach of Segerson and Wu (2006) to the case that the ambient level of nonpoint source pollution is stochastic. It is shown that when the random component is bounded from the above, fine-tuning the cutoff value of the tax payments avoids the actual imposition of the tax while the threat of such payments retains necessary incentive for the polluters to engage in abatements at the optimal level. If the random component is not bounded, the imposition of the tax cannot be completely avoided but the probability can be reduced by setting a higher cutoff value. It is also noted that the regulator has additional flexibility in randomizing the tax imposition but the randomization process has to be credible. Copyright © 2013 Elsevier Ltd. All rights reserved.

Traffic rule violations of private bus drivers and bus crashes in Sri Lanka: a case-control study.

PubMed

Jayatilleke, Achala Upendra; Poudel, Krishna C; Nakahara, Shinji; Dharmaratne, Samath D; Jayatilleke, Achini Chinthika; Jimba, Masamine

2010-06-01

To explore the association between self-reported traffic rule violations of private sector bus drivers and bus crashes in the Kandy district, Sri Lanka. We carried out a case-control study from August to September 2006. Cases were all the private bus drivers registered in the Kandy district and involved in crashes reported to the police between November 2005 and April 2006 (n = 63). We included two control groups: the private bus drivers working on the same routes of the cases (n = 90; matched controls) and the drivers selected randomly from the other routes of the district (n = 111; unmatched controls). We used a self-administered questionnaire to collect data on the self-reported traffic rule violations and analyzed the association between the self-reported traffic rule violations and crashes using logistic regression. The following variables showed significant associations with private bus crashes: illegal overtaking (matched controls, adjusted odds ratio [AOR] = 14.78, unmatched controls, AOR = 1.04), taking passengers outside the bus bays (matched controls, AOR = 3.96, unmatched controls, AOR = 2.29), and overloading (matched controls, AOR = 10.26, unmatched controls, AOR = 1.93). However, we did not observe an association between high-speed driving and bus crashes matched controls, AOR = 1.22, unmatched controls, AOR = 0.81. Traffic rule violations, such as illegal overtaking, overloading, and taking passengers outside the bus bays, are significant risk factors for private bus crashes in Sri Lanka.

Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study.

PubMed

Hudon, Catherine; Chouinard, Maud-Christine; Dubois, Marie-France; Roberge, Pasquale; Loignon, Christine; Tchouaket, Éric; Lambert, Mireille; Hudon, Émilie; Diadiou, Fatoumata; Bouliane, Danielle

2018-05-01

This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation. We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months. The second phase had a qualitative descriptive design and entailed thematic analysis of in-depth interviews (25 patients, 6 case management nurses, 9 health managers) and focus groups (8 patients' spouses, 21 family physicians) to understand stakeholders' perceived effects of the intervention on patients. A total of 247 patients were randomized into the intervention group (n = 126) or the control group (n = 121). Compared with usual care, the intervention reduced psychological distress (odds ratio = 0.43; 95% CI, 0.19-0.95, P = .04), but did not have any significant effect on patient activation ( P = .43). Qualitative results suggested that patients and their spouses benefitted from the case management intervention, gaining a sense of security, and stakeholders noted better patient self-management of health. Together, our study's quantitative and qualitative results suggest that case management reduces psychological distress, making patients and caregivers feel more secure, whereas impact on self-management is unclear. Case management is a promising avenue to improve outcomes among frequent users of health care with complex needs. © 2018 Annals of Family Medicine, Inc.

Intra-alveolar epsilon-aminocaproic acid for the control of post-extraction bleeding in anticoagulated patients: randomized clinical trial.

PubMed

da Silva, R V; Gadelha, T B; Luiz, R R; Torres, S R

2018-03-27

The aim of this study was to compare the effectiveness of the intra-alveolar administration of epsilon-aminocaproic acid (EACA) and daily gentle rinsing with EACA mouthwash with that of routine postoperative procedures for the control of bleeding after tooth extraction in anticoagulated patients. A randomized clinical trial was conducted involving 52 patients submitted to 140 tooth extractions, assigned randomly to two groups. The intervention group was treated with intra-alveolar administration of EACA immediately after surgery and gentle rinsing with EACA mouthwash during the postoperative period. The control group received routine postoperative recommendations. A single episode of immediate bleeding occurred in the intervention group. Late bleeding episodes occurred in 23 procedures (16.4%): 11 (15.7%) in the intervention group and 12 (17.1%) in the control group. Among the patients with late bleeding, 18 (78.3%) events were classified as moderate and were controlled by the patient applying pressure to a gauze pack placed over the extraction socket. The remaining five cases (21.7%) required re-intervention. No statistically significant difference in the frequency of postoperative bleeding was observed between the groups. Thus, routine measures were as effective for the control of bleeding after simple tooth extractions in anticoagulated patients as the topical administration of EACA. Copyright © 2018 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Obstacles in Using Randomization Tests in Single-Case Experimentation.

ERIC Educational Resources Information Center

Kazdin, Alan E.

1980-01-01

Problems associated with randomization tests in single- case experiments are discussed. This article follows a discussion of randomization tests in single case studies in the same issue of this journal. (See TM 505 799; 505 801).(Author/JKS)

Epidemiological characteristics of cases of death from tuberculosis and vulnerable territories1

PubMed Central

Yamamura, Mellina; Santos-Neto, Marcelino; dos Santos, Rebeca Augusto Neman; Garcia, Maria Concebida da Cunha; Nogueira, Jordana de Almeida; Arcêncio, Ricardo Alexandre

2015-01-01

Objective: to characterize the differences in the clinical and epidemiological profile of cases of death that had tuberculosis as an immediate or associated cause, and to analyze the spatial distribution of the cases of death from tuberculosis within the territories of Ribeirão Preto, Brazil. Method: an ecological study, in which the population consisted of 114 cases of death from tuberculosis. Bivariate analysis was carried out, as well as point density analysis, defined with the Kernel estimate. Results: of the cases of death from tuberculosis, 50 were the immediate cause and 64 an associated cause. Age (p=.008) and sector responsible for the death certificate (p=.003) were the variables that presented statistically significant associations with the cause of death. The spatial distribution, in both events, did not occur randomly, forming clusters in areas of the municipality. Conclusion: the difference in the profiles of the cases of death from tuberculosis, as a basic cause and as an associated cause, was governed by the age and the sector responsible for the completion of the death certificate. The non-randomness of the spatial distribution of the cases suggests areas that are vulnerable to these events. Knowing these areas can contribute to the choice of disease control strategies. PMID:26487142

Evaluation of moxifloxacin 0.5% in treatment of nonperforated bacterial corneal ulcers: a randomized controlled trial.

PubMed

Sharma, Namrata; Goel, Manik; Bansal, Shubha; Agarwal, Prakashchand; Titiyal, Jeewan S; Upadhyaya, Ashish D; Vajpayee, Rasik B

2013-06-01

To compare the equivalence of moxifloxacin 0.5% with a combination of fortified cefazolin sodium 5% and tobramycin sulfate 1.3% eye drops in the treatment of moderate bacterial corneal ulcers. Randomized, controlled, equivalence clinical trial. Microbiologically proven cases of bacterial corneal ulcers were enrolled in the study and were allocated randomly to 1 of the 2 treatment groups. Group A was given combination therapy (fortified cefazolin sodium 5% and tobramycin sulfate) and group B was given monotherapy (moxifloxacin 0.5%). The primary outcome variable for the study was percentage of the ulcers healed at 3 months. The secondary outcome variables were best-corrected visual acuity and resolution of infiltrates. Of a total of 224 patients with bacterial keratitis, 114 patients were randomized to group A, whereas 110 patients were randomized to group B. The mean ± standard deviation ulcer size in groups A and B were 4.2 ± 2 and 4.41 ± 1.5 mm, respectively. The prevalence of coagulase-negative Staphylococcus (40.9% in group A and 48.2% in group B) was similar in both the study groups. A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8%) in group A and 88 patients (81.4%) in group B at 3 months. The observed percentage of healing at 3 months was less than the equivalence margin of 20%. Worsening of ulcer was seen in 18.2% cases in group A and in 18.5% cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P = 0.065). No serious events attributable to therapy were reported. Corneal healing using 0.5% moxifloxacin monotherapy is equivalent to that of combination therapy using fortified cefazolin and tobramycin in the treatment of moderate bacterial corneal ulcers. The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Nitrates in municipal drinking water and non-Hodgkin lymphoma: an ecological cancer case-control study in Taiwan.

PubMed

Chang, Chih-Ching; Tsai, Shang-Shyue; Wu, Trong-Neng; Yang, Chun-Yuh

2010-01-01

The relationship between nitrate levels in drinking water and increased risk of non-Hodgkin lymphoma (NHL) development has been inconclusive. A matched cancer case-control and a nitrate ecology study was used to investigate the association between mortality attributed to NHL and nitrate exposure from Taiwan's drinking water. All deaths due to NHL in Taiwan residents from 2000 through 2006 were obtained from the Bureau of Vital Statistics of the Taiwan Provincial Department of Health. Controls were deaths from other causes and were pair-matched to the cases by gender, year of birth, and year of death. Each matched control was selected randomly from the set of possible controls for each case. Data on nitrate-nitrogen (NO(3)-N) levels of drinking water throughout Taiwan were collected from the Taiwan Water Supply Corporation (TWSC). The municipality of residence for cancer cases and controls was presumed to be the source of the subject's nitrate exposure via drinking water. The adjusted odds ratios (OR) for NHL death for those with high nitrate levels in their drinking water, as compared to the lowest tertile, were 1.02 (0.87-1.2) and 1.05 (0.89-1.24), respectively. The results of the present study show that there was no statistically significant association between nitrates in drinking water at levels in this investigation and increased risk of death attributed to NHL.

Nitrate in drinking water and risk of death from bladder cancer: an ecological case-control study in Taiwan.

PubMed

Chiu, Hui-Fen; Tsai, Shang-Shyue; Yang, Chun-Yuh

2007-06-01

The relationship between nitrate levels in drinking water and bladder cancer development is controversial. A matched cancer case-control with nitrate ecology study was used to investigate the association between bladder cancer mortality occurrence and nitrate exposure from Taiwan drinking water. All bladder cancer deaths of Taiwan residents from 1999 through 2003 were obtained from the Bureau of Vital Statistics of the Taiwan Provincial Department of Health. Controls were deaths from other causes and were pair-matched to the cases by gender, year of birth,and year of death. Each matched control was selected randomly from the set of possible controls for each cancer case. Data on nitrate-nitrogen (NO3-N) levels in drinking water throughout Taiwan were collected from Taiwan Water Supply Corporation (TWSC). The municipality of residence for cancer cases and controls was assumed to be the source of the subject's nitrate exposure via drinking water. The adjusted odds ratios for bladder cancer death for those with high nitrate levels in their drinking water were 1.76 (1.28-2.42) and 1.96 (1.41-2.72) as compared to the lowest tertile. The results of the present study show that there was a significant positive relationship between the levels of nitrate in drinking water and risk of death from bladder cancer.

Impact of traffic oscillations on freeway crash occurrences.

PubMed

Zheng, Zuduo; Ahn, Soyoung; Monsere, Christopher M

2010-03-01

Traffic oscillations are typical features of congested traffic flow that are characterized by recurring decelerations followed by accelerations (stop-and-go driving). The negative environmental impacts of these oscillations are widely accepted, but their impact on traffic safety has been debated. This paper describes the impact of freeway traffic oscillations on traffic safety. This study employs a matched case-control design using high-resolution traffic and crash data from a freeway segment. Traffic conditions prior to each crash were taken as cases, while traffic conditions during the same periods on days without crashes were taken as controls. These were also matched by presence of congestion, geometry and weather. A total of 82 cases and about 80,000 candidate controls were extracted from more than three years of data from 2004 to 2007. Conditional logistic regression models were developed based on the case-control samples. To verify consistency in the results, 20 different sets of controls were randomly extracted from the candidate pool for varying control-case ratios. The results reveal that the standard deviation of speed (thus, oscillations) is a significant variable, with an average odds ratio of about 1.08. This implies that the likelihood of a (rear-end) crash increases by about 8% with an additional unit increase in the standard deviation of speed. The average traffic states prior to crashes were less significant than the speed variations in congestion. Published by Elsevier Ltd.

Practices that minimize trauma to the genital tract in childbirth: a systematic review of the literature.

PubMed

Renfrew, M J; Hannah, W; Albers, L; Floyd, E

1998-09-01

Trauma to the genital tract commonly occurs at birth, and can cause short- and long-term morbidity. Clinical measures to reduce its occurrence have not been fully identified. A systematic review of the English language literature was conducted to describe the current state of knowledge on reduction of genital tract trauma before planning a large randomized controlled trial of ways to prevent such trauma. Randomized trials and other published reports were identified from relevant databases and hand searches. Studies were reviewed and assessed using a structured format. A total of 77 papers and chapters were identified and placed into 5 categories after critical review: 25 randomized trials, 4 meta-analyses, 4 prospective studies, 36 retrospective studies, and 8 descriptions of practice from textbooks. The available evidence is conclusive in favor of restricted use of episiotomy. The contribution of maternal characteristics and attitudes to intact perineum has not been investigated. Several other topics warrant further study, including maternal position, style of pushing, and antenatal perineal massage. Strong opinions and sparse data exist regarding the role of hand maneuvers by the birth attendant for perineal management and birth of the baby. This became the topic of the planned randomized controlled trial, which was completed; results will be published soon. The case for restricting the use of episiotomy is conclusive. Several other clinical factors warrant investigation, including the role of hand maneuvers by the birth attendant in preventing birth trauma. A large randomized controlled trial will report on this topic.

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

PubMed

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

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

Parent-Infant Vocalisations at 12 Months Predict Psychopathology at 7 Years

ERIC Educational Resources Information Center

Allely, C. S.; Purves, D.; McConnachie, A.; Marwick, H.; Johnson, P.; Doolin, O.; Puckering, C.; Golding, J.; Gillberg, C.; Wilson, P.

2013-01-01

This study investigated the utility of adult and infant vocalisation in the prediction of child psychopathology. Families were sampled from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Vocalisation patterns were obtained from 180 videos (60 cases and 120 randomly selected sex-matched controls) of parent-infant…

A Randomized Clinical Trial of a Money Management Intervention for Veterans With Psychiatric Disabilities.

PubMed

Elbogen, Eric B; Hamer, Robert M; Swanson, Jeffrey W; Swartz, Marvin S

2016-10-01

The study evaluated an intervention to help veterans with psychiatric disabilities, who face a unique set of challenges concerning money management. A randomized clinical trial was conducted of a brief (one to three hours) psychoeducational, recovery-oriented money management intervention called $teps for Achieving Financial Empowerment ($AFE). Analyses revealed no main effects on outcomes of random assignment to $AFE (N=67) or a control condition consisting of usual care (N=77). Veterans who reported using $AFE skills showed significantly lower impulsive buying, more responsible spending, higher rates of engaging in vocational activities, and greater number of work hours compared with veterans in the control condition. Findings have clinical implications for case management services involving informal money management assistance. Offering veterans with psychiatric disabilities a one-time money management intervention is unlikely to lead to substantial changes. Results imply that efforts to improve psychosocial outcomes among veterans must not only teach but also increase use of money management skills.

The case for randomized controlled trials to assess the impact of clinical information systems.

PubMed

Liu, Joseph L Y; Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit.

Nurse-Facilitated Health Checks for Persons With Severe Mental Illness: A Cluster-Randomized Controlled Trial.

PubMed

White, Jacquie; Lucas, Joanne; Swift, Louise; Barton, Garry R; Johnson, Harriet; Irvine, Lisa; Abotsie, Gabriel; Jones, Martin; Gray, Richard J

2018-05-01

This study tested the effectiveness of a nurse-delivered health check with the Health Improvement Profile (HIP), which takes approximately 1.5 hours to complete and code, for persons with severe mental illness. A single-blind, cluster-randomized controlled trial was conducted in England to test whether health checks improved the general medical well-being of persons with severe mental illness at 12-month follow-up. Sixty nurses were randomly assigned to the HIP group or the treatment-as-usual group. From their case lists, 173 patients agreed to participate. HIP group nurses completed health checks for 38 of their 90 patients (42%) at baseline and 22 (24%) at follow-up. No significant between-group differences were noted in patients' general medical well-being at follow-up. Nurses who had volunteered for a clinical trial administered health checks only to a minority of participating patients, suggesting that it may not be feasible to undertake such lengthy structured health checks in routine practice.

The case for randomized controlled trials to assess the impact of clinical information systems

PubMed Central

Wyatt, Jeremy C

2011-01-01

There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

The Role of Melatonin in the Treatment of Primary Headache Disorders

PubMed Central

Gelfand, Amy A.; Goadsby, Peter J.

2016-01-01

Objective To provide a summary of knowledge about the use of melatonin in the treatment of primary headache disorders. Background Melatonin is secreted by the pineal gland; its production is regulated by the hypothalamus and increases during periods of darkness. Methods We undertook a narrative review of the literature on the role of melatonin in the treatment of primary headache disorders. Results There are randomized placebo-controlled trials examining melatonin for preventive treatment of migraine and cluster headache. For cluster headache, melatonin 10 mg was superior to placebo. For migraine, a randomized placebo-controlled trial of melatonin 3 mg (immediate release) was positive, though an underpowered trial of melatonin 2 mg (sustained release) was negative. Uncontrolled studies, case series, and case reports cover melatonin’s role in treating tension-type headache, hypnic headache, hemicrania continua, SUNCT/SUNA and primary stabbing headache. Conclusions Melatonin may be effective in treating several primary headache disorders, particularly cluster headache and migraine. Future research should focus on elucidating the underlying mechanisms of benefit of melatonin in different headache disorders, as well as clarifying optimal dosing and formulation. PMID:27316772

Hair Loss Myths.

PubMed

DiMarco, Gabriella; McMichael, Amy

2017-07-01

INTRODUCTION: Hair loss is a common complaint seen in dermatology clinics. From frustration and attempts at self-help, patients with hair loss may present to the dermatologist with false beliefs, or myths, about the causes of their condition and what treatments are effective.

METHODS: We identified 12 common myths about hair loss, categorized as myths about minoxidil treatment, vitamin and mineral supplements, natural topical treatments, and hair care practices. We performed a PubMed search to find evidence to support or refute each myth.

RESULTS: We found that there is little evidence to support many of these common hair loss myths. In some cases, randomized controlled trials have investigated the effects of particular therapies and point to the effectiveness of certain hair loss treatments.

DISCUSSION: In many cases, there have not been sufficient randomized controlled trials to evaluate the effect of different therapies and hair care practices on hair loss. It is best to guide patients toward treatments with a long track record of efficacy and away from those where little is known scientifically.

J Drugs Dermatol. 2017;16(7):690-694.

Effectiveness and Cost of Insecticide-Treated Bed Nets and Indoor Residual Spraying for the Control of Cutaneous Leishmaniasis: A Cluster-Randomized Control Trial in Morocco

PubMed Central

Faraj, Chafika; Yukich, Joshua; Adlaoui, El Bachir; Wahabi, Rachid; Mnzava, Abraham Peter; Kaddaf, Mustapha; El Idrissi, Abderrahmane Laamrani; Ameur, Btissam; Kleinschmidt, Immo

2016-01-01

Cutaneous leishmaniasis (CL) remains an important public health problem in Morocco. A cluster-randomized trial was conducted with the following three study arms: 1) long-lasting insecticide-treated nets (LLINs) plus standard of care environmental management (SoC-EM), 2) indoor residual spraying (IRS) with α-cypermethrin plus SoC-EM, and 3) SoC-EM alone. Incidence of new CL cases by passive and active case detection, sandfly abundance, and cost and cost-effectiveness was compared between study arms over 5 years. Incidence of CL and sandfly abundance were significantly lower in the IRS arm compared with SoC-EM (CL incidence rate ratio = 0.32, 95% confidence interval [CI] = 0.15–0.69, P = 0.005 and sandfly abundance ratio = 0.39, 95% CI = 0.18–0.85, P = 0.022). Reductions in the LLIN arm of the study were not significant, possibly due to poor compliance. IRS was effective and more cost-effective for the prevention of CL in Morocco. PMID:26811431

A Single Session of Mirror-based Tactile and Motor Training Improves Tactile Dysfunction in Children with Unilateral Cerebral Palsy: A Replicated Randomized Controlled Case Series.

PubMed

Auld, Megan L; Johnston, Leanne M; Russo, Remo N; Moseley, G Lorimer

2017-10-01

This replicated randomized controlled crossover case series investigated the effect of mirror-based tactile and motor training on tactile registration and perception in children with unilateral cerebral palsy (UCP). Six children with UCP (6-18 years; median 10 years, five male, three-left hemiplegia, four-manual ability classification system (MACS) I, one MACS II and one MACS III) participated. They attended two 90-minute sessions - one of mirror-based training and one of standard practice, bimanual therapy - in alternated order. Tactile registration (Semmes Weinstein Monofilaments) and perception (double simultaneous or single-point localization) were assessed before and after each session. Change was estimated using reliable change index (RCI). Tactile perception improved in four participants (RCI > 1.75), with mirror-based training, but was unchanged with bimanual therapy (RCI < 1.0 for all participants). Neither intervention affected tactile registration. Mirror-based training demonstrates potential to improve tactile perception in children with UCP. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters

PubMed Central

2011-01-01

Background Suicide attempts (SA) constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Methods/Design Multicentre randomized controlled trial. We examine the effectiveness of «ALGOS algorithm»: an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters) and «Crisis card» (effective only in first-attempters). Participants who are lost from contact and those refusing healthcare, can then benefit from «short letters» or «postcards». Discussion ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy. Trial Registration The study was registered with the ClinicalTrials.gov Registry; number: NCT01123174. PMID:21194496

Communication Among Melanoma Family Members

PubMed Central

Bowen, Deborah J; Albrecht, Terrance; Hay, Jennifer; Eggly, Susan; Harris-Wei, Julie; Meischke, Hendrika; Burke, Wylie

2017-01-01

Interventions to improve communication among family members may facilitate information flow about familial risk and preventive health behaviors. This is a secondary analysis of the effects of an interactive website intervention aimed at increasing communication frequency and agreement about health risk among melanoma families. Participants were family units, consisting of one family member with melanoma identified from a previous research study (the case) and an additional first degree relative and a parent of a child 0–17. Family triads were randomized to receive access to the website intervention or to serve as control families. Family communication frequency and agreement about melanoma prevention behaviors and beliefs were measured at baseline and again at one year post randomization. Intervention participants of all three types significantly increased the frequency of communication to their first degree relatives (Parents, siblings, children; range =14–18 percentage points; all p<0.05). At baseline approximately two-thirds of all three family members talked with at least some member of the family about cancer risk. Agreement between Cases and First Degree Relatives and between Cases and Parents increased from pre to post intervention in the intervention participants compared to the control participants (p<0.05). These findings provide support for interventions to improve family communication about cancer risk. PMID:28248624

Communication Among Melanoma Family Members.

PubMed

Bowen, Deborah J; Albrecht, Terrance; Hay, Jennifer; Eggly, Susan; Harris-Wei, Julie; Meischke, Hendrika; Burke, Wylie

2017-03-01

Interventions to improve communication among family members may facilitate information flow about familial risk and preventive health behaviors. This is a secondary analysis of the effects of an interactive website intervention aimed at increasing communication frequency and agreement about health risk among melanoma families. Participants were family units, consisting of one family member with melanoma identified from a previous research study (the Case) and an additional first degree relative and a parent of a child 0-17. Family triads were randomized to receive access to the website intervention or to serve as control families. Family communication frequency and agreement about melanoma prevention behaviors and beliefs were measured at baseline and again at 1 year post randomization. Intervention participants of all three types significantly increased the frequency of communication to their first degree relatives (Parents, siblings, children; range = 14-18 percentage points; all p < .05). At baseline, approximately two-thirds of all three family members talked with at least some member of the family about cancer risk. Agreement between Cases and First Degree Relatives and between Cases and Parents increased from pre to post intervention in the intervention participants compared to the control participants (p < .05). These findings provide support for interventions to improve family communication about cancer risk.

Risk factors for tuberculosis among health care workers in South India: a nested case-control study.

PubMed

Mathew, Anoop; David, Thambu; Thomas, Kurien; Kuruvilla, P J; Balaji, V; Jesudason, Mary V; Samuel, Prasanna

2013-01-01

The epidemiology of tuberculosis (TB) among health care workers (HCWs) in India remains under-researched. This study is a nested case-control design assessing the risk factors for acquiring TB among HCWs in India. It is a nested case-control study conducted at a tertiary teaching hospital in India. Cases (n = 101) were HCWs with active TB. Controls (n = 101) were HCWs who did not have TB, randomly selected from the 6,003 subjects employed at the facility. Cases and controls were compared with respect to clinical and demographic variables. The cases and controls were of similar age. Logistic regression analysis showed that body mass index (BMI) <19 kg/m(2) (odds ratio [OR]: 2.96, 95% confidence interval [CI]: 1.49-5.87), having frequent contact with patients (OR: 2.83, 95% CI: 1.47-5.45) and being employed in medical wards (OR: 12.37, 95% CI: 1.38-110.17) or microbiology laboratories (OR: 5.65, 95% CI: 1.74-18.36) were independently associated with increased risk of acquiring TB. HCWs with frequent patient contact and those with BMI <19 kg/m(2) were at high risk of acquiring active TB. Nosocomial transmission of TB was pronounced in locations, such as medical wards and microbiology laboratories. Surveillance of high-risk HCWs and appropriate infrastructure modifications may be important to prevent interpersonal TB transmission in health care facilities. Copyright © 2013 Elsevier Inc. All rights reserved.

Preliminary Findings of a Randomized Trial of Non-Pharmaceutical Interventions to Prevent Influenza Transmission in Households

PubMed Central

Cowling, Benjamin J.; Fung, Rita O. P.; Cheng, Calvin K. Y.; Fang, Vicky J.; Chan, Kwok Hung; Seto, Wing Hong; Yung, Raymond; Chiu, Billy; Lee, Paco; Uyeki, Timothy M.; Houck, Peter M.; Peiris, J. S. Malik; Leung, Gabriel M.

2008-01-01

Background There are sparse data on whether non-pharmaceutical interventions can reduce the spread of influenza. We implemented a study of the feasibility and efficacy of face masks and hand hygiene to reduce influenza transmission among Hong Kong household members. Methodology/Principal Findings We conducted a cluster randomized controlled trial of households (composed of at least 3 members) where an index subject presented with influenza-like-illness of <48 hours duration. After influenza was confirmed in an index case by the QuickVue Influenza A+B rapid test, the household of the index subject was randomized to 1) control or 2) surgical face masks or 3) hand hygiene. Households were visited within 36 hours, and 3, 6 and 9 days later. Nose and throat swabs were collected from index subjects and all household contacts at each home visit and tested by viral culture. The primary outcome measure was laboratory culture confirmed influenza in a household contact; the secondary outcome was clinically diagnosed influenza (by self-reported symptoms). We randomized 198 households and completed follow up home visits in 128; the index cases in 122 of those households had laboratory-confirmed influenza. There were 21 household contacts with laboratory confirmed influenza corresponding to a secondary attack ratio of 6%. Clinical secondary attack ratios varied from 5% to 18% depending on case definitions. The laboratory-based or clinical secondary attack ratios did not significantly differ across the intervention arms. Adherence to interventions was variable. Conclusions/Significance The secondary attack ratios were lower than anticipated, and lower than reported in other countries, perhaps due to differing patterns of susceptibility, lack of significant antigenic drift in circulating influenza virus strains recently, and/or issues related to the symptomatic recruitment design. Lessons learnt from this pilot have informed changes for the main study in 2008. Trial Registration ClinicalTrials.gov NCT00425893 HKClinicalTrials.com HKCTR-365 PMID:18461182

Prevalence of radiographic hip osteoarthritis is increased in high bone mass.

PubMed

Hardcastle, S A; Dieppe, P; Gregson, C L; Hunter, D; Thomas, G E R; Arden, N K; Spector, T D; Hart, D J; Laugharne, M J; Clague, G A; Edwards, M H; Dennison, E M; Cooper, C; Williams, M; Davey Smith, G; Tobias, J H

2014-08-01

Epidemiological studies have shown an association between increased bone mineral density (BMD) and osteoarthritis (OA), but whether this represents cause or effect remains unclear. In this study, we used a novel approach to investigate this question, determining whether individuals with High Bone Mass (HBM) have a higher prevalence of radiographic hip OA compared with controls. HBM cases came from the UK-based HBM study: HBM was defined by BMD Z-score. Unaffected relatives of index cases were recruited as family controls. Age-stratified random sampling was used to select further population controls from the Chingford and Hertfordshire cohort studies. Pelvic radiographs were pooled and assessed by a single observer blinded to case-control status. Analyses used logistic regression, adjusted for age, gender and body mass index (BMI). 530 HBM hips in 272 cases (mean age 62.9 years, 74% female) and 1702 control hips in 863 controls (mean age 64.8 years, 84% female) were analysed. The prevalence of radiographic OA, defined as Croft score ≥3, was higher in cases compared with controls (20.0% vs 13.6%), with adjusted odds ratio (OR) [95% CI] 1.52 [1.09, 2.11], P = 0.013. Osteophytes (OR 2.12 [1.61, 2.79], P < 0.001) and subchondral sclerosis (OR 2.78 [1.49, 5.18], P = 0.001) were more prevalent in cases. However, no difference in the prevalence of joint space narrowing (JSN) was seen (OR 0.97 [0.72, 1.33], P = 0.869). An increased prevalence of radiographic hip OA and osteophytosis was observed in HBM cases compared with controls, in keeping with a positive association between HBM and OA and suggesting that OA in HBM has a hypertrophic phenotype. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Case Management of Dengue: Lessons Learned

PubMed Central

Kalayanarooj, Siripen; Srikiatkhachorn, Anon

2017-01-01

Abstract The global burden of dengue and its geographic distribution have increased over the past several decades. The introduction of dengue in new areas has often been accompanied by high case-fatality rates. Drawing on the experience in managing dengue cases at the Queen Sirikit National Institute of Child Health in Bangkok, Thailand, this article provides the authors’ perspectives on key clinical lessons to improve dengue-related outcomes. Parallels between this clinical experience and outcomes reported in randomized controlled trials, results of efforts to disseminate practice recommendations, and suggestions for areas for further research are also discussed. PMID:28403440

Biomarkers and Bacterial Pneumonia Risk in Patients with Treated HIV Infection: A Case-Control Study

PubMed Central

Bjerk, Sonja M.; Baker, Jason V.; Emery, Sean; Neuhaus, Jacqueline; Angus, Brian; Gordin, Fred M.; Pett, Sarah L.; Stephan, Christoph; Kunisaki, Ken M.

2013-01-01

Background Despite advances in HIV treatment, bacterial pneumonia continues to cause considerable morbidity and mortality in patients with HIV infection. Studies of biomarker associations with bacterial pneumonia risk in treated HIV-infected patients do not currently exist. Methods We performed a nested, matched, case-control study among participants randomized to continuous combination antiretroviral therapy (cART) in the Strategies for Management of Antiretroviral Therapy trial. Patients who developed bacterial pneumonia (cases) and patients without bacterial pneumonia (controls) were matched 1∶1 on clinical center, smoking status, age, and baseline cART use. Baseline levels of Club Cell Secretory Protein 16 (CC16), Surfactant Protein D (SP-D), C-reactive protein (hsCRP), interleukin-6 (IL-6), and d-dimer were compared between cases and controls. Results Cases (n = 72) and controls (n = 72) were 25.7% female, 51.4% black, 65.3% current smokers, 9.7% diabetic, 36.1% co-infected with Hepatitis B/C, and 75.0% were on cART at baseline. Median (IQR) age was 45 (41, 51) years with CD4+ count of 553 (436, 690) cells/mm3. Baseline CC16 and SP-D were similar between cases and controls, but hsCRP was significantly higher in cases than controls (2.94 µg/mL in cases vs. 1.93 µg/mL in controls; p = 0.02). IL-6 and d-dimer levels were also higher in cases compared to controls, though differences were not statistically significant (p-value 0.06 and 0.10, respectively). Conclusions In patients with cART-treated HIV infection, higher levels of systemic inflammatory markers were associated with increased bacterial pneumonia risk, while two pulmonary-specific inflammatory biomarkers, CC16 and SP-D, were not associated with bacterial pneumonia risk. PMID:23457535

[Efficacy and safety of reduced osmolarity oral rehydration salts in treatment of dehydration in children with acute diarrhea--a multicenter, randomized, double blind clinical trial].

PubMed

Yang, Dao-Feng; Guo, Wei; Tian, De-Ying; Luo, Xiao-Ping; He, Yong-Wen; Dai, Yong-An; Xu, Hua-Lin

2007-04-01

To assess the efficacy and safety of reduced osmolarity oral rehydration salts (ROORS) in treatment of mild to moderate dehydration caused by acute diarrhea in children. A multicenter, randomized, double-blind, positive drug controlled clinical trial was conducted in 125 cases aged 1 to 17 years. These children with acute diarrhea and signs of dehydration were randomly assigned to receive either ROORS (trial group, n = 62) or oral rehydration salts II (ORS II) (control group, n = 63). The volume of intravenous infusion were recorded. The improvements of systemic symtoms and signs, diarrhea, dehydration and total scores were compared between the two groups. The adverse events and changes of electrolyte and other laboratory tests during treatment were also observed and analyzed. The overall effective rates in trial group and control group were 96.8% and 96.8%, respectively. The recovery of systemic symptoms, dehydration signs and diarrhea occurred in 96%, 97% and 78% patients in trial groups, and 96%, 98% and 85% patients in control group. The scores of symptoms and signs in both groups decreased significantly after treatment. All the above parameters and the number of cases who needed intravenous infusion (41 vs. 39) were not statistically different between two groups. However, the average volume of intravenously infused fluids in trial group was (450.98 +/- 183.07) ml, 24.5% less than that in the control group (597.30 +/- 343.37) ml (P < 0.05). The mean serum Na(+) concentration elevated from (137.48 +/- 4.55) mmol/L to (139.52 +/- 3.25) mmol/L (P < 0.01) in control group after treatment, but the change was not statistically significant in trail group. Serum K(+), Cl(-), HCO(3)(-) and other laboratory result did not change significantly after treatment. The total scores in both groups decreased obviously after treatment, but no significant difference was demonstrated between two groups (P > 0.05). A case in trial group had mild abdominal distention and recovered spontaneously. ROORS was shown to be effective and safe in the treatment of mild and moderate dehydration induced by acute diarrhea. Compared to ORS II, ROORS could decrease the intravenous supplement of fluid and lower the risk of hypernatremia.

Selection of population controls for a Salmonella case-control study in the UK using a market research panel and web-survey provides time and resource savings.

PubMed

Mook, P; Kanagarajah, S; Maguire, H; Adak, G K; Dabrera, G; Waldram, A; Freeman, R; Charlett, A; Oliver, I

2016-04-01

Timely recruitment of population controls in infectious disease outbreak investigations is challenging. We evaluated the timeliness and cost of using a market research panel as a sampling frame for recruiting controls in a case-control study during an outbreak of Salmonella Mikawasima in the UK in 2013. We deployed a web-survey by email to targeted members of a market research panel (panel controls) in parallel to the outbreak control team interviewing randomly selected public health staff by telephone and completing paper-based questionnaires (staff controls). Recruitment and completion of exposure history web-surveys for panel controls (n = 123) took 14 h compared to 15 days for staff controls (n = 82). The average staff-time cost per questionnaire for staff controls was £13·13 compared to an invoiced cost of £3·60 per panel control. Differences in the distribution of some exposures existed between these control groups but case-control studies using each group found that illness was associated with consumption of chicken outside of the home and chicken from local butchers. Recruiting market research panel controls offers time and resource savings. More rapid investigations would enable more prompt implementation of control measures. We recommend that this method of recruiting controls is considered in future investigations and assessed further to better understand strengths and limitations.

Effect of Rivastigmine Augmentation in Treatment of Male Patients With Combat-Related Chronic Posttraumatic Stress Disorder: A Randomized Controlled Trial.

PubMed

Rezaei Ardani, Amir; Hosseini, Golkoo; Fayyazi Bordbar, Mohammad Reza; Talaei, Ali; Mostafavi Toroghi, Hesam

2017-02-01

Posttraumatic stress disorder (PTSD) is one of the chronic and disabling psychiatric disorders, particularly in combat veterans. In a case series, rivastigmine was suggested to be an effective augmentation in treatment of PTSD. The aim of the present study was to evaluate this finding in a randomized controlled trial. A 12-week, double-blind, placebo-controlled clinical trial was performed on 36 male patients (aged 42-60 years) diagnosed with chronic, combat-related PTSD. Subjects were screened for apparent cognitive deficits by means of Mini-Mental State Examination. All patients received selective serotonin reuptake inhibitors plus sodium valproate for 4 weeks and then reevaluated. Subjects who did not show adequate response were randomly assigned into 3 groups receiving rivastigmine (up to 6 mg/d), placebo, or the prior treatment regimen. Efficacy of medication was measured by administering PTSD Check List-Military Version at baseline and weeks 2, 4, 8, and 12. Collected data were analyzed by analysis of variance and repeated measurement. Reported differences were considered significant at the level of 0.05 or less. The 3 groups showed statistically significant reductions in the total PTSD Check List-Military Version, avoidance subscale, and the reexperience subscale but not in the hyperarousal subscale. No significant differences were found between the 3 groups. In contrast to the previous case series, findings of the current study did not support the efficacy of adjunctive rivastigmine in treatment of PTSD. This hypothetically could be due to the fact that all the study's subjects scored higher than 25 on Mini-Mental State Examination.

[A multicenter randomized controlled study of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea in infants and young children].

PubMed

Wan, C M; Yu, H; Liu, G; Xu, H M; Mao, Z Q; Xu, Y; Jin, Y; Luo, R P; Wang, W J; Fang, F

2017-05-04

Objective: To evaluate the efficacy and safety of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea (AAD) in infants and young children. Method: From November 2012 to September 2013, ten research units of large teaching hospitals or children's hospitals participated in this multicenter randomized controlled clinical trial. Hospitalized young children aged between 1 month and 3 years (nongastrointestinal infection and antibiotic therapy required)were involved in our study. The children were randomly divided into control group and prevention group by means of block random allocation method. The control group received antibiotic therapy and other conventional treatment. The prevention group was given additional Saccharomyces boulardii (250 mg/d) orally. Diarrhea rates of two groups were compared both during the usage of antibiotics and within 14 days after the antibiotics withdrawal. The adverse reactions of Saccharomyces boulardii were observed all through this study. The results were analyzed by χ(2) test or Kruskal-Wallis test or t test. Result: Totally 408 cases (213 cases in prevention group and 195 cases in control group) were enrolled. The age ranged from 1 month to 3 years, with an average age of 1.14 years. The basic diseases were parenteral infections: 368 cases with different kinds of respiratory tract infections or pneumonia, 10 cases of bacterial meningitis, 9 cases with septicemia or sepsis, 6 cases with pertussis or pertussis like syndrome, 5 cases with urinary infection, 5 cases with skin or subcutaneous tissue infections, 3 cases of Kawasaki disease, one with scarlet fever and one with congenital syphilis. During the administration of antibiotics, the incidence of AAD in prevention group was 10.3% (22 cases), which was significantly lower than that of control group (57 cases, 29.2%, χ(2)=23.296, P <0.05). Within 14 days after the discontinuation of antibiotics, the percent of new diarrhea cases in prevention group (2.4%, 5/213) was also significantly lower than that in control group (16.4%, 32/195, χ(2)=23.4, P <0.05). Further analysis revealed that the rate of AAD in children less than or equal to 1 year old (25.1%, 52/207) was significantly higher than that of over 1 year old (13.4%, 27/201, χ(2)=8.922, P <0.05). The incidence of AAD in children treated with antibiotics for more than 5 days was 22.2%(60/270), which was significantly higher than that of less than or equal to 5 days (13.8%, 19/138, χ(2)=4.180, P <0.05). Although no significant difference was observed, the AAD rate of patients with combined use of two antibiotics was higher than that of using one. During the antibiotic therapy, compared with the control group, the risk of AAD in children under 1 year old was reduced by 52% (χ(2)=9.217, P <0.05), and 91% (χ(2)=20.35, P <0.05) in the children over 1 year old in prevention group. The risk of AAD of prevention group decreased by 66% (χ(2)=13.67, P <0.05) in patients treated with one antibiotics, and 65% in children with combined use of antibiotics (χ(2)=10.57, P <0.05). In patients treated with antibiotics for less than or equal to 5 days, the risk of AAD decreased by 74% in prevention group (χ(2)=7.38, P <0.05); and 63% if the course lasted for over 5 days (χ(2)=16.87, P <0.05). Within 14 days after the withdrawal of antibiotics, compared with the control group, the risk of diarrhea in the prevention group decreased by 82% (χ(2)=13.35, P <0.05) in infants (≤1 year old) and 93% (χ(2)=12.00, P <0.05) in children (>1 year old); the risk of diarrhea was reduced by 86% (χ(2)=9.57, P <0.05) and 87% (χ(2)=17.71, P <0.05) respectively in prevention group with single and combined use of antibiotics. In patients treated with antibiotics for more than 5 days, the risk of diarrhea in prevention group was reduced by 63% (χ(2)=22.79, P <0.05), while there was no significant difference if the antibiotics course was less than or equal to 5 days (χ(2)=2.97, P >0.05). No adverse effects related with Saccharomyces boulardii were observed in our study. Conclusion: Saccharomyces boulardii is effective and safe to prevent AAD of infants and young children both during the usage of antibiotics and up to 14 days after drug discontinuance. It can be one of the drugs of for choice prevention of AAD in infants and young children. Trial registration Chinese Clinical Trial Tegister, ChiECRCT-2012-25.

Rib fractures in trauma patients: does operative fixation improve outcome?

PubMed

Majak, Peter; Næss, Pål A

2016-12-01

Renewed interest in surgical fixation of rib fractures has emerged. However, conservative treatment is still preferred at most surgical departments. We wanted to evaluate whether operative treatment of rib fractures may benefit severely injured patients. Several studies report a reduction in mechanical ventilation time, ICU length of stay (LOS), hospital LOS, pneumonia, need for tracheostomy, pain and costs in operatively treated patients with multiple rib fractures compared with patients treated nonoperatively. Although patient selection and timing of the operation seem crucial for successful outcome, no consensus exists. Mortality reduction has only been shown in a few studies. Most studies are retrospective cohort and case-control studies. Only four randomized control trials exist. Conservative treatment, consisting of respiratory assistance and pain control, is still the treatment of choice in the vast majority of patients with multiple rib fractures. In selected patients, operative fixation of fractured ribs within 72 h postinjury may lead to better outcome. More randomized control trials are needed to further determine who benefits from surgical fixation of rib fractures.

[Periodontal treatment for cardiovascular risk factors: a systematic review].

PubMed

Deng, Linkai; Li, Chunjie; Li, Qian; Zhang, Yukui; Zhao, Hongwei

2013-10-01

To evaluate the efficacy of periodontal treatment for the management of cardiovascular risk factors. Eligible studies in Cochrane Controlled Trials Register/CENTRAL, PubMed, EMBASE, and China Biology Medicine disc (CBMdisc) were searched until October 13, 2011. References of the included studies were hand searched. Two reviewers assessed the risk of bias and extracted the data of the included studies in duplicate. Meta-analysis was conducted with Revman 5.1. Six randomized controlled trials involving 682 participants were included. One case had low risk of bias, another one had moderate risk of bias, and the remaining four had high risk of bias. Meta-analysis showed that periodontal treatment has no significant effect on C-reactive protein, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P > 0.05). However, the treatment had a significant effect on high-density lipoprotein cholesterol [MD = 0.05, 95% CI (0.00, 0.09), P = 0.04]. Periodontal treatment has good effects on controlling high-density lipoprotein cholesterol although more randomized controlled trials must be conducted to verify its effectiveness.

Heparin for prolonging peripheral intravenous catheter use in neonates: a randomized controlled trial.

PubMed

Upadhyay, A; Verma, K K; Lal, P; Chawla, D; Sreenivas, V

2015-04-01

To determine the efficacy of heparinized saline administered as intermittent flush on functional duration of the peripheral intravenous catheter (PIVC) in neonates. Randomized, double-blind and placebo-controlled trial. Neonatal intensive care unit of a teaching hospital. Term and preterm neonates born at >32 weeks of gestation who required PIVC only for intermittent administration of antibiotics. Eligible neonates were randomized to receive 1 ml of either heparinized saline (10 U ml(-1)) (n=60) or normal saline (n=60) every 12 h before and after intravenous antibiotics. Functional duration of first peripheral intravenous catheter. A total of 120 neonates were randomized to two groups of 60 neonates each. The mean (s.d.) of age of babies in case and control group was 5.7 (2.5) days and 4.6 (3.1) days, respectively. The average weight of babies in both the groups was 2.1 kg. Mean functional duration of first catheter was more in heparinized saline group, mean (s.d.) of 71.68 h  (27.3) as compared with 57.7 h (23.6) in normal saline group (P<0.005). The mean (95% confidence interval) difference in functional duration in the two groups was 13.9 h (4.7-23.15). Mean duration of patency for any catheter was also significantly more in heparinized saline group than control group. Heparinized saline flush increases the functional duration of peripheral intravenous catheter.

Effects of date palm pollen on fertility: research proposal for a systematic review.

PubMed

Abdi, Fatemeh; Roozbeh, Nasibeh; Mortazavian, Amir Mohammad

2017-08-01

Over 10-15% of couples in different countries are infertile. Male infertility is a contributing factor and the only cause of infertility in respectively 50% and 20-30% of all cases of infertility. According to previous research, micro-elements isolated from date palm pollen (DPP), e.g. estrogen and sterols, may enhance male and female fertility. DPP has also been reported to improve sperm parameters including sperm motility and viability, acrosome reaction, and lipid peroxidation. This article may justify the need for a future systematic review and meta-analysis about the effects of DPP on the reproductive system and DPP's ability to enhance fertility. It will then describe the methodology of such a study. A comprehensive search of relevant randomized and quasi-randomized controlled trials will be performed in MEDLINE, EMBASE, Web of Science, Cochrane Central, ProQuest, and Google Scholar databases. Two authors will independently assess the eligibility of the studies and consult the third author in cases of disagreement. The risk of bias of the randomized controlled trials and animal studies will be evaluated using the Cochrane risk of bias tool and the Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool, respectively. This study will raise no ethical issues as it will review the findings of previous research. The results are intended to be published in a peer-reviewed medical journal.

Prevalence of depression and anxiety among undergraduate university students in low- and middle-income countries: a systematic review protocol.

PubMed

January, James; Madhombiro, Munyaradzi; Chipamaunga, Shalote; Ray, Sunanda; Chingono, Alfred; Abas, Melanie

2018-04-10

Depression and anxiety symptoms are reported to be common among university students in many regions of the world and impact on quality of life and academic attainment. The extent of the problem of depression and anxiety among students in low- and middle-income countries (LMICs) is largely unknown. This paper details methods for a systematic review that will be conducted to explore the prevalence, antecedents, consequences, and treatments for depression and anxiety among undergraduate university students in LMICs. Studies reporting primary data on common mental disorders among students in universities and colleges within LMICs will be included. Quality assessment of retrieved articles will be conducted using four Joanna Briggs critical appraisal checklists for prevalence, randomized control/pseudo-randomized trials, descriptive case series, and comparable cohort/case control. Meta-analysis of the prevalence of depression and anxiety will be conducted using a random effects model which will generate pooled prevalence with their respective 95% confidence intervals. The results from this systematic review will help in informing and guiding healthcare practitioners, planners, and policymakers on the burden of common mental disorders in university students in LMICs and of appropriate and feasible interventions aimed at reducing the burden of psychological morbidity among them. The results will also point to gaps in research and help set priorities for future enquiries. PROSPERO CRD42017064148.

Modafinil for the Improvement of Patient Outcomes Following Traumatic Brain Injury.

PubMed

Borghol, Amne; Aucoin, Michael; Onor, Ifeanyichukwu; Jamero, Dana; Hawawini, Fadi

2018-04-01

Objective : The authors sought to assess the literature evidence on the efficacy of modafinil use in patients with fatigue or excessive daytime sleepiness (EDS) secondary to traumatic brain injury (TBI). Method of Research : A literature search of Medline and PubMed was performed using the EBSCOhost database. Primary literature, observational studies, meta-analyses, case reports, and systematic reviews were assessed for content regarding modafinil and psychostimulant use in patients with TBI. Of the 23 articles collected, three randomized, controlled studies, three observational studies, one case report, and two systematic reviews gave a description of modafinil use in TBI patients. Results and Conclusion : Modafinil is a central nervous system stimulant with well-established effectiveness in the treatment of narcolepsy and shift-work sleep disorder. There is conflicting evidence about the benefits of modafinil in the treatment of fatigue and EDS secondary to TBI. One randomized, controlled study states that modafinil does not significantly improve patient wakefulness, while another concludes that modafinil corrects EDS but not fatigue. An observational study provides evidence that modafinil increases alertness in fatigued patients with past medical history of brainstem diencephalic stroke or multiple sclerosis. Modafinil appears to have the potential to improve wakefulness in patients with TBI. A prospective, double-blinded, randomized, crossover trial of modafinil for the management of fatigue in ischemic stroke patients is currently being conducted, and further studies demonstrating consistent results are needed before making a conclusive decision.

Efficacy of antimicrobial photodynamic therapy in the disinfection of acrylic denture surfaces: A systematic review.

PubMed

Varela Kellesarian, Sergio; Abduljabbar, Tariq; Vohra, Fahim; Malmstrom, Hans; Yunker, Michael; Varela Kellesarian, Tammy; Romanos, Georgios E; Javed, Fawad

2017-03-01

The aim of the present systematic review was to assess the efficacy of antimicrobial photodynamic therapy (aPDT) in the disinfection of acrylic denture surfaces. IN order to address the focused question: "Is aPDT more effective in decontaminating denture surfaces compared with traditional denture-disinfection techniques?" an electronic search without time or language restrictions was conducted up to November 2016 in indexed databases using different key words. The exclusion criteria included qualitative and/or quantitative reviews, case reports, case series, commentaries, letters to the editor, interviews, and updates. A total of 14 studies were included and processed for data extraction, out of which 1 study was a randomized clinical trial and 13 studies were performed in vitro. Results from 12 experimental studies reported that aPDT was effective in reducing bacteria and/or yeast cultured in single or multispecies biofilm growth on acrylic resin specimens. One experimental study reported selective microorganism reduction on acrylic resin after aPDT. One clinical randomized control trial reported that aPDT presented similar microorganism reduction compared with oral antifungal medication for the disinfection of denture surfaces. The role of aPDT in the disinfection of acrylic resin surfaces is unclear. From a clinical perspective further randomized control trials are needed to assess the efficacy of aPDT in the disinfection of acrylic resin surfaces. Copyright © 2016 Elsevier B.V. All rights reserved.

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

Effects of unipedal standing balance exercise on the prevention of falls and hip fracture among clinically defined high-risk elderly individuals: a randomized controlled trial.

PubMed

Sakamoto, Keizo; Nakamura, Toshitaka; Hagino, Hiroshi; Endo, Naoto; Mori, Satoshi; Muto, Yoshiteru; Harada, Atsushi; Nakano, Tetsuo; Itoi, Eiji; Yoshimura, Mitsuo; Norimatsu, Hiromichi; Yamamoto, Hiroshi; Ochi, Takahiro

2006-10-01

The aim of this study was to assess the effectiveness of the unipedal standing balance exercise for 1 min to prevent falls and hip fractures in high-risk elderly individuals with a randomized controlled trial. This control study was designed as a 6-month intervention trial. Subjects included 553 clinically defined high-risk adults who were living in residences or in the community. They were randomized to an exercise group and a control group. Randomization to the subjects was performed by a table of random numbers. A unipedal standing balance exercise with open eyes was performed by standing on each leg for 1 min three times per day. As a rule, subjects of the exercise group stood on one leg without holding onto any support, but unstable subjects were permitted to hold onto a bar during the exercise time. Falls and hip fractures were reported by nurses, physical therapists, or facility staff with a survey sheet every month. This survey sheet was required every month for both groups. Registered subjects were 553 persons ranging in age from 37 to 102 years (average, 81.6 years of age). Twenty-six subjects dropped out. The number of falls and hip fractures for the 6-month period after the trial for 527 of the 553 subjects for whom related data were available were assessed. The exercise group comprised 315 subjects and the control group included 212 subjects. The cumulative number of falls of the exercise group, with 1 multiple faller omitted, was 118, and the control group recorded 121 falls. A significant intergroup difference was observed. However, the cumulative number of hip fractures was only 1 case in both groups. This difference was not statistically significant. The unipedal standing balance exercise is effective to prevent falls but was not shown to be statistically significant in the prevention of hip fracture in this study.

Restaurant outbreak of Legionnaires' disease associated with a decorative fountain: an environmental and case-control study

PubMed Central

O'Loughlin, Rosalyn E; Kightlinger, Lon; Werpy, Matthew C; Brown, Ellen; Stevens, Valerie; Hepper, Clark; Keane, Tim; Benson, Robert F; Fields, Barry S; Moore, Matthew R

2007-01-01

Background From June to November 2005, 18 cases of community-acquired Legionnaires' disease (LD) were reported in Rapid City South Dakota. We conducted epidemiologic and environmental investigations to identify the source of the outbreak. Methods We conducted a case-control study that included the first 13 cases and 52 controls randomly selected from emergency department records and matched on underlying illness. We collected information about activities of case-patients and controls during the 14 days before symptom onset. Environmental samples (n = 291) were cultured for Legionella. Clinical and environmental isolates were compared using monoclonal antibody subtyping and sequence based typing (SBT). Results Case-patients were significantly more likely than controls to have passed through several city areas that contained or were adjacent to areas with cooling towers positive for Legionella. Six of 11 case-patients (matched odds ratio (mOR) 32.7, 95% CI 4.7-∞) reported eating in Restaurant A versus 0 controls. Legionella pneumophila serogroup 1 was isolated from four clinical specimens: 3 were Benidorm type strains and 1 was a Denver type strain. Legionella were identified from several environmental sites including 24 (56%) of 43 cooling towers tested, but only one site, a small decorative fountain in Restaurant A, contained Benidorm, the outbreak strain. Clinical and environmental Benidorm isolates had identical SBT patterns. Conclusion This is the first time that small fountain without obvious aerosol-generating capability has been implicated as the source of a LD outbreak. Removal of the fountain halted transmission. PMID:17688692

Asthma in changing environments - chances and challenges of international research collaborations between South America and Europe - study protocol and description of the data acquisition of a case-control-study

PubMed Central

2010-01-01

Background Asthma in children is an emerging public health problem in South America. So far, research in this part of the world is limited. This paper presents the methodology and description of the data acquisition of an asthma case-control study conducted in the Central South of Chile. Methods/Design A hospital-based case-control study about asthma (188 cases, 294 controls) in children (6-15 years) was carried out in Valdivia, Chile between November 2008 and December 2009. Data on asthma risk factors were collected by computer-assisted personal interview using validated questions from e.g. ISAAC phase II. Data on household dust exposure (endotoxin, allergen analyses), skin prick tests to most common allergens, stool examinations for parasitic infection, and blood samples (total IgE, genetics) were collected. Additionally, 492 randomly chosen blood donors were recruited in order to assess allele frequencies in the population of Valdivia. Discussion Overall 1,173 participants were contacted. Response was 82% among cases and 65% among controls. Atopic sensitization was high (78% among cases, 47% among controls). Cases had a statistically significantly (p < .0001) increased self-reported 12-month prevalence of symptoms of rhinitis (82% vs. 51%) and wheeze (68% vs. 16%). The study is well placed to address current hypotheses about asthma and its correlates in the South American context. Results of this study might help develop novel, innovative and individualized prevention strategies in countries in transition with respect to the South American context. PMID:20718949

The Mortality Penalty of Incarceration: Evidence from a Population-based Case-control Study of Working-age Males.

PubMed

Pridemore, William Alex

2014-06-01

There is a growing body of research on the effects of incarceration on health, though there are few studies in the sociological literature of the association between incarceration and premature mortality. This study examined the risk of male premature mortality associated with incarceration. Data came from the Izhevsk (Russia) Family Study, a large-scale population-based case-control design. Cases (n = 1,750) were male deaths aged 25 to 54 in Izhevsk between October 2003 and October 2005. Controls (n = 1,750) were selected at random from a city population register. The key independent variable was lifetime prevalence of incarceration. I used logistic regression to estimate mortality odds ratios, controlling for age, hazardous drinking, smoking status, marital status, and education. Seventeen percent of cases and 5 percent of controls had been incarcerated. Men who had been incarcerated were more than twice as likely as those who had not to experience premature mortality (odds ratio = 2.2, 95 percent confidence interval: 1.6-3.0). Relative to cases with no prior incarceration, cases who had been incarcerated were more likely to die from infectious diseases, respiratory diseases, non-alcohol-related accidental poisonings, and homicide. Taken together with other recent research, these results from a rigorous case-control design reveal not only that incarceration has durable effects on illness, but that its consequences extend to a greater risk of early death. I draw on the sociology of health literature on exposure, stress, and social integration to speculate about the reasons for this mortality penalty of incarceration. © American Sociological Association 2014.

Systematic review: an evaluation of major commercial weight loss programs in the United States.

PubMed

Tsai, Adam Gilden; Wadden, Thomas A

2005-01-04

Each year millions of Americans enroll in commercial and self-help weight loss programs. Health care providers and their obese patients know little about these programs because of the absence of systematic reviews. To describe the components, costs, and efficacy of the major commercial and organized self-help weight loss programs in the United States that provide structured in-person or online counseling. Review of company Web sites, telephone discussion with company representatives, and search of the MEDLINE database. Randomized trials at least 12 weeks in duration that enrolled only adults and assessed interventions as they are usually provided to the public, or case series that met these criteria, stated the number of enrollees, and included a follow-up evaluation that lasted 1 year or longer. Data were extracted on study design, attrition, weight loss, duration of follow-up, and maintenance of weight loss. We found studies of eDiets.com, Health Management Resources, Take Off Pounds Sensibly, OPTIFAST, and Weight Watchers. Of 3 randomized, controlled trials of Weight Watchers, the largest reported a loss of 3.2% of initial weight at 2 years. One randomized trial and several case series of medically supervised very-low-calorie diet programs found that patients who completed treatment lost approximately 15% to 25% of initial weight. These programs were associated with high costs, high attrition rates, and a high probability of regaining 50% or more of lost weight in 1 to 2 years. Commercial interventions available over the Internet and organized self-help programs produced minimal weight loss. Because many studies did not control for high attrition rates, the reported results are probably a best-case scenario. With the exception of 1 trial of Weight Watchers, the evidence to support the use of the major commercial and self-help weight loss programs is suboptimal. Controlled trials are needed to assess the efficacy and cost-effectiveness of these interventions.

Clinical Perspectives of Genetic Analyses on Dyslipidemia and Coronary Artery Disease

PubMed Central

Kawashiri, Masa-aki; Yamagishi, Masakazu

2017-01-01

We have learned that low-density lipoprotein (LDL) cholesterol is the cause of atherosclerosis from various aspects, including a single case with familial hypercholesterolemia, other cases with different types of Mendelian dyslipidemias, large-scale randomized controlled trials using LDL cholesterol lowering therapies, and Mendelian randomization studies using common as well as rare variants associated with LDL cholesterol levels. There is no doubt that determinations of genotypes in lipid-associated genes have contributed not only to the genetic diagnosis for Mendelian dyslipidemias but also to the discoveries of novel therapeutic targets. Furthermore, recent studies have shown that such genetic information could provide useful clues for the risk prediction as well as risk stratification in general and in particular population. We provide the current understanding of genetic analyses relating to plasma lipids and coronary artery disease. PMID:28250266

Rheumatoid Arthritis and Cardiovascular Disease: Update on Treatment Issues

PubMed Central

Barbhaiya, Medha; Solomon, Daniel H.

2016-01-01

Purpose of review This review examines thresholds for treatment of traditional cardiovascular disease (CVD) risk factors among RA patients and whether RA-specific treatment modulates cardiovascular risk. Recent findings There are substantial data demonstrating an increased CVD risk among patients with RA. Both traditional CVD risk factors and inflammation contribute to this risk. Recent epidemiologic studies strengthen the case that aggressive immunosuppression with biologic DMARDs, such as TNF antagonists, is associated with a reduced risk of CVD events. However, to data, there are no randomized controlled trials published regarding the management of CVD in RA. Summary Epidemiologic evidence continues to accumulate regarding the relationship between the effects of traditional CVD risk factors and RA-specific treatments on CV outcomes in RA. The field needs randomized controlled trials to better guide management. PMID:23466960

Consequences of anorectal cancer atlas implementation in the cooperative group setting: radiobiologic analysis of a prospective randomized in silico target delineation study.

PubMed

Mavroidis, Panayiotis; Giantsoudis, Drosoula; Awan, Musaddiq J; Nijkamp, Jasper; Rasch, Coen R N; Duppen, Joop C; Thomas, Charles R; Okunieff, Paul; Jones, William E; Kachnic, Lisa A; Papanikolaou, Niko; Fuller, Clifton D

2014-09-01

The aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas. Using a representative case and target volume delineation instructions derived from a proposed IMRT rectal cancer clinical trial, gross tumor volume (GTV) and clinical/planning target volumes (CTV/PTV) were contoured by 13 physician observers (Phase 1). The observers were then randomly assigned to follow (atlas) or not-follow (control) a consensus guideline/atlas for anorectal cancers, and instructed to re-contour the same case (Phase 2). The atlas group was found to have increased tumor control probability (TCP) after the atlas intervention for both the CTV (p<0.0001) and PTV1 (p=0.0011) with decreasing normal tissue complication probability (NTCP) for small intestine, while the control group did not. Additionally, the atlas group had reduced variance in TCP for all target volumes and reduced variance in NTCP for the bowel. In Phase 2, the atlas group had increased TCP relative to the control for CTV (p=0.03). Visual atlas and consensus treatment guideline usage in the development of rectal cancer IMRT treatment plans reduced the inter-observer radiobiological variation, with clinically relevant TCP alteration for CTV and PTV volumes. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Laparoscopic-Assisted Resection of Colorectal Malignancies

PubMed Central

Chapman, Andrew E.; Levitt, Michael D.; Hewett, Peter; Woods, Rodney; Sheiner, Harry; Maddern, Guy J.

2001-01-01

Objective To compare the safety and efficacy of laparoscopic-assisted resection of colorectal malignancies with open colectomy. Methods Two search strategies were devised to retrieve literature from the Medline, Current Contents, Embase, and Cochrane Library databases until July 1999. Inclusion of papers was determined using a predetermined protocol, independent assessments by two reviewers, and a final consensus decision. English language papers were selected. Acceptable study designs included randomized controlled trials, controlled clinical trials, case series, or case reports. Fifty-two papers met the inclusion criteria. They were tabulated and critically appraised in terms of methodology and design, outcomes, and the possible influence of bias, confounding, and chance. Results Little high-level evidence was available. Laparoscopic resection of colorectal malignancy was more expensive and time-consuming, but little evidence suggests high rates of port site recurrence. The new procedure’s advantages revolve around early recovery from surgery and reduced pain. Conclusions The evidence base for laparoscopic-assisted resection of colorectal malignancies is inadequate to determine the procedure’s safety and efficacy. Because of inadequate evidence detailing circumferential marginal clearance of tumors and the necessity of determining a precise incidence of cardiac and other major complications, along with wound and port site recurrence, it is recommended that a controlled clinical trial, ideally with random allocation to an intervention and control group, be conducted. Long-term survival rates need to be a primary aim of such a trial. PMID:11685021

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

PubMed

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

2014-11-01

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

Indoor pollution as an occupational risk factor for tuberculosis among women: a population-based, gender oriented, case-control study in Southern Mexico.

PubMed

García-Sancho, Ma Cecilia; García-García, Lourdes; Báez-Saldaña, Renata; Ponce-De-León, Alfredo; Sifuentes-Osornio, José; Bobadilla-Del-valle, Miriam; Ferreyra-Reyes, Leticia; Cano-Arellano, Bulmaro; Canizales-Quintero, Sergio; Palacios-Merino, Luz del Carmen; Juárez-Sandino, Luis; Ferreira-Guerrero, Elizabeth; Cruz-Hervert, Luis Pablo; Small, Peter M; Pérez-Padilla, José Rogelio

2009-01-01

Indoor air pollution produced by biomass cooking fuels in developing countries has been associated with acute and chronic lower respiratory diseases, but has not been identified as an occupational exposure among women. To examine the relationship between the use of biomass cooking fuels (mainly wood) and tuberculosis (TB) among women living in rural areas in Southern Mexico. We conducted a population based case-control study in the health jurisdiction of Orizaba, Mexico. Cases were all incident female pulmonary TB patients, with Mycobacterium tuberculosis in sputum, living in communities with fewer than 15,000 inhabitants, diagnosed between March 1995 and April 2003. Woodsmoke exposure was assessed by applying a standardized questionnaire (ATS-DLD-78 questionnaire). Controls were randomly selected from sex-matched neighbors. Appropriate IRB approval was obtained. 42 TB cases and 84 community controls were recruited. Multivariate assessment showed that more than 20 years of exposure to smoke from biomass fuels was three times more frequent among cases than among controls [Odds ratio (OR): 3.3, 95% confidence interval (CI):1.06-10.30, p = 0.03], after controlling for age, body mass, household crowding, years of formal education and tobacco use. We found a strong association between the use of biomass cooking fuels and tuberculosis among women in a community-based, case-control study. Results of this study are intended to provide evidence to policy makers, community leaders and the general public on the importance of implementing gender oriented interventions that decrease the use of biomass fuels in poor communities in developing countries.

Development and validation of a melanoma risk score based on pooled data from 16 case-control studies

PubMed Central

Davies, John R; Chang, Yu-mei; Bishop, D Timothy; Armstrong, Bruce K; Bataille, Veronique; Bergman, Wilma; Berwick, Marianne; Bracci, Paige M; Elwood, J Mark; Ernstoff, Marc S; Green, Adele; Gruis, Nelleke A; Holly, Elizabeth A; Ingvar, Christian; Kanetsky, Peter A; Karagas, Margaret R; Lee, Tim K; Le Marchand, Loïc; Mackie, Rona M; Olsson, Håkan; Østerlind, Anne; Rebbeck, Timothy R; Reich, Kristian; Sasieni, Peter; Siskind, Victor; Swerdlow, Anthony J; Titus, Linda; Zens, Michael S; Ziegler, Andreas; Gallagher, Richard P.; Barrett, Jennifer H; Newton-Bishop, Julia

2015-01-01

Background We report the development of a cutaneous melanoma risk algorithm based upon 7 factors; hair colour, skin type, family history, freckling, nevus count, number of large nevi and history of sunburn, intended to form the basis of a self-assessment webtool for the general public. Methods Predicted odds of melanoma were estimated by analysing a pooled dataset from 16 case-control studies using logistic random coefficients models. Risk categories were defined based on the distribution of the predicted odds in the controls from these studies. Imputation was used to estimate missing data in the pooled datasets. The 30th, 60th and 90th centiles were used to distribute individuals into four risk groups for their age, sex and geographic location. Cross-validation was used to test the robustness of the thresholds for each group by leaving out each study one by one. Performance of the model was assessed in an independent UK case-control study dataset. Results Cross-validation confirmed the robustness of the threshold estimates. Cases and controls were well discriminated in the independent dataset (area under the curve 0.75, 95% CI 0.73-0.78). 29% of cases were in the highest risk group compared with 7% of controls, and 43% of controls were in the lowest risk group compared with 13% of cases. Conclusion We have identified a composite score representing an estimate of relative risk and successfully validated this score in an independent dataset. Impact This score may be a useful tool to inform members of the public about their melanoma risk. PMID:25713022

Impact of an Intervention Designed to Reduce Sexual Health Risk Behaviors of African American Adolescents: Results of a Randomized Controlled Trial

PubMed Central

Jenner, Lynne W.; Walsh, Sarah; Demby, Hilary; Gregory, Alethia; Davis, Erin

2016-01-01

Objectives. To replicate an evidence-based HIV risk reduction program and assess its impact on 2 behavioral outcomes—inconsistency of condom use and frequency of sex—6 months after the program. Methods. The study was an individual-level randomized controlled trial in which we randomly assigned 850 youths (aged 14–18 years) to 1 of 2 conditions. The treatment (Becoming a Responsible Teen) is a group-level sociocognitive and skills training sexual education course; the control is a general health intervention that includes the same initial informational component as the treatment. Participants were recruited over 3 summers (2012–2014) from a summer employment program in New Orleans, Louisiana, that serves primarily African American adolescents. Results. Six months after program exposure, we found no statistically significant difference between treatment and control group members’ self-reported inconsistency of condom use or frequency of sex (P > .05). Conclusions. Although previous evidence has indicated that this particular program can be effective, this study’s findings indicate that it was not effective in this setting with this specific population. Results should provide an incentive to learn why the intervention works in some cases and what conditions are necessary for causal impacts. PMID:27689499

A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia

PubMed Central

Latkin, Carl A.; Kukhareva, Polina V.; Malov, Sergey V.; Batluk, Julia V.; Shaboltas, Alla V.; Skochilov, Roman V.; Sokolov, Nicolay V.; Verevochkin, Sergei V.; Hudgens, Michael G.; Kozlov, Andrei P.

2014-01-01

We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs. PMID:23881187

Randomized control trial follow-up: Online program and waiting period for unmarried parents in Title IV-D Court.

PubMed

Rudd, Brittany N; Poladian, Ani R; Holtzworth-Munroe, Amy; Applegate, Amy G; D'Onofrio, Brian M

2017-04-01

Despite a lack of research on parent programs for separating unmarried parents, many judicial officers mandate participation. Rudd, Holtzworth-Munroe, Reyome, Applegate, and D'Onofrio (2015) conducted the only randomized controlled trial of any online parent program for separating parents, ProudToParent.org (PTP), and related court processes (e.g., having a waiting period between the establishment of paternity and the court hearing regarding child related issues vs. having the hearing the same day). They recruited a unique sample of 182 cases in a Title IV-D Court (i.e., a court for primarily low income parents) (Authorization of Appropriations, 42 U.S.C. § 651, 2013), in which paternity was previously contested but subsequently established via court-ordered genetic testing. Unexpectedly, cases assigned to PTP and a waiting period were the least likely to reach agreement at their court hearing. In the current study, we extend these results to examine the impact of the study conditions on relitigation in the year following the court hearing; only 11.2% of cases filed a motion, and 7.8% had a hearing. The group that was least likely to reach full initial agreement (i.e., assigned to PTP and the waiting period) were the most likely to relitigate. Further, controlling for study conditions, reaching a full agreement in the Title IV-D court decreased the odds of having a court hearing in the following year. Reaching agreements on the specific issues involved in such cases (e.g., custody, child support) reduced the likelihood of both motions and hearings in the year after the Title IV-D hearings. The implications of these findings are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A randomized trial of the effect of prayer on depression and anxiety.

PubMed

Boelens, Peter A; Reeves, Roy R; Replogle, William H; Koenig, Harold G

2009-01-01

To investigate the effect of direct contact person-to-person prayer on depression, anxiety, positive emotions, and salivary cortisol levels. Cross-over clinical trial with depression or anxiety conducted in an office setting. Following randomization to the prayer intervention or control groups, subjects (95% women) completed Hamilton Rating Scales for Depression and Anxiety, Life Orientation Test, Daily Spiritual Experiences Scale, and underwent measurement of cortisol levels. Individuals in the direct person-to-person prayer contact intervention group received six weekly 1-hour prayer sessions while those in the control group received none. Rating scales and cortisol levels were repeated for both groups after completion of the prayer sessions, and a month later. ANOVAs were used to compare pre- and post-prayer measures for each group. At the completion of the trial, participants receiving the prayer intervention showed significant improvement of depression and anxiety, as well as increases of daily spiritual experiences and optimism compared to controls (p < 0.01 in all cases). Subjects in the prayer group maintained these significant improvements (p < 0.01 in all cases) for a duration of at least 1 month after the final prayer session. Participants in the control group did not show significant changes during the study. Cortisol levels did not differ significantly between intervention and control groups, or between pre- and post-prayer conditions. Direct contact person-to-person prayer may be useful as an adjunct to standard medical care for patients with depression and anxiety. Further research in this area is indicated.

Identifying barriers to recovery from work related upper extremity disorders: use of a collaborative problem solving technique.

PubMed

Shaw, William S; Feuerstein, Michael; Miller, Virginia I; Wood, Patricia M

2003-08-01

Improving health and work outcomes for individuals with work related upper extremity disorders (WRUEDs) may require a broad assessment of potential return to work barriers by engaging workers in collaborative problem solving. In this study, half of all nurse case managers from a large workers' compensation system were randomly selected and invited to participate in a randomized, controlled trial of an integrated case management (ICM) approach for WRUEDs. The focus of ICM was problem solving skills training and workplace accommodation. Volunteer nurses attended a 2 day ICM training workshop including instruction in a 6 step process to engage clients in problem solving to overcome barriers to recovery. A chart review of WRUED case management reports (n = 70) during the following 2 years was conducted to extract case managers' reports of barriers to recovery and return to work. Case managers documented from 0 to 21 barriers per case (M = 6.24, SD = 4.02) within 5 domains: signs and symptoms (36%), work environment (27%), medical care (13%), functional limitations (12%), and coping (12%). Compared with case managers who did not receive the training (n = 67), workshop participants identified more barriers related to signs and symptoms, work environment, functional limitations, and coping (p < .05), but not to medical care. Problem solving skills training may help focus case management services on the most salient recovery factors affecting return to work.

Experience with multiple control groups in a large population-based case-control study on genetic and environmental risk factors.

PubMed

Pomp, E R; Van Stralen, K J; Le Cessie, S; Vandenbroucke, J P; Rosendaal, F R; Doggen, C J M

2010-07-01

We discuss the analytic and practical considerations in a large case-control study that had two control groups; the first control group consisting of partners of patients and the second obtained by random digit dialling (RDD). As an example of the evaluation of a general lifestyle factor, we present body mass index (BMI). Both control groups had lower BMIs than the patients. The distribution in the partner controls was closer to that of the patients, likely due to similar lifestyles. A statistical approach was used to pool the results of both analyses, wherein partners were analyzed with a matched analysis, while RDDs were analyzed without matching. Even with a matched analysis, the odds ratio with partner controls remained closer to unity than with RDD controls, which is probably due to unmeasured confounders in the comparison with the random controls as well as intermediary factors. However, when studying injuries as a risk factor, the odds ratio remained higher with partner control subjects than with RRD control subjects, even after taking the matching into account. Finally we used factor V Leiden as an example of a genetic risk factor. The frequencies of factor V Leiden were identical in both control groups, indicating that for the analyses of this genetic risk factor the two control groups could be combined in a single unmatched analysis. In conclusion, the effect measures with the two control groups were in the same direction, and of the same order of magnitude. Moreover, it was not always the same control group that produced the higher or lower estimates, and a matched analysis did not remedy the differences. Our experience with the intricacies of dealing with two control groups may be useful to others when thinking about an optimal research design or the best statistical approach.

Random search optimization based on genetic algorithm and discriminant function

NASA Technical Reports Server (NTRS)

Kiciman, M. O.; Akgul, M.; Erarslanoglu, G.

1990-01-01

The general problem of optimization with arbitrary merit and constraint functions, which could be convex, concave, monotonic, or non-monotonic, is treated using stochastic methods. To improve the efficiency of the random search methods, a genetic algorithm for the search phase and a discriminant function for the constraint-control phase were utilized. The validity of the technique is demonstrated by comparing the results to published test problem results. Numerical experimentation indicated that for cases where a quick near optimum solution is desired, a general, user-friendly optimization code can be developed without serious penalties in both total computer time and accuracy.

A Cluster Randomized Evaluation of a Health Department Data to Care Intervention Designed to Increase Engagement in HIV Care and Antiretroviral Use.

PubMed

Dombrowski, Julia C; Hughes, James P; Buskin, Susan E; Bennett, Amy; Katz, David; Fleming, Mark; Nunez, Angela; Golden, Matthew R

2018-06-01

Many US health departments have implemented Data to Care interventions, which use HIV surveillance data to identify persons who are inadequately engaged in HIV medical care and assist them with care reengagement, but the effectiveness of this strategy is uncertain. We conducted a stepped-wedge, cluster-randomized evaluation of a Data to Care intervention in King County, Washington, 2011 to 2014. Persons diagnosed as having HIV for at least 6 months were eligible based on 1 of 2 criteria: (1) viral load (VL) greater than 500 copies/mL and CD4 less than 350 cells/μL at the last report in the past 12 months or (2) no CD4 or VL reported to the health department for at least 12 months. The intervention included medical provider contact, patient contact, and a structured individual interview. Health department staff assisted patients with reengagement using health systems navigation, brief counseling, and referral to support services. We clustered all eligible cases in the county by the last known medical provider and randomized the order of clusters for intervention, creating contemporaneous intervention and control periods (cases in later clusters contributed person-time to the control period at the same time that cases in earlier clusters contributed person-time to the intervention period). We compared the time to viral suppression (VL <200 copies/mL) for individuals during intervention and control periods using a Cox proportional hazards model. We identified 997 persons (intention to treat [ITT]), 18% of whom had moved or died. Of the remaining 822 (modified ITT), 161 (20%) had an undetectable VL reported before contact and 164 (20%) completed the individual interview. The hazard ratio (HR) for time to viral suppression did not differ between the intervention and control periods in ITT (HR, 1.21 [95% confidence interval, 0.85-1.71]) or modified ITT (HR, 1.18 [95% confidence interval, 0.83-1.68]) analysis. The Data to Care intervention did not impact time to viral suppression.

Insight into Best Variables for COPD Case Identification: A Random Forests Analysis.

PubMed

Leidy, Nancy K; Malley, Karen G; Steenrod, Anna W; Mannino, David M; Make, Barry J; Bowler, Russ P; Thomashow, Byron M; Barr, R G; Rennard, Stephen I; Houfek, Julia F; Yawn, Barbara P; Han, Meilan K; Meldrum, Catherine A; Bacci, Elizabeth D; Walsh, John W; Martinez, Fernando

This study is part of a larger, multi-method project to develop a questionnaire for identifying undiagnosed cases of chronic obstructive pulmonary disease (COPD) in primary care settings, with specific interest in the detection of patients with moderate to severe airway obstruction or risk of exacerbation. To examine 3 existing datasets for insight into key features of COPD that could be useful in the identification of undiagnosed COPD. Random forests analyses were applied to the following databases: COPD Foundation Peak Flow Study Cohort (N=5761), Burden of Obstructive Lung Disease (BOLD) Kentucky site (N=508), and COPDGene® (N=10,214). Four scenarios were examined to find the best, smallest sets of variables that distinguished cases and controls:(1) moderate to severe COPD (forced expiratory volume in 1 second [FEV 1 ] <50% predicted) versus no COPD; (2) undiagnosed versus diagnosed COPD; (3) COPD with and without exacerbation history; and (4) clinically significant COPD (FEV 1 <60% predicted or history of acute exacerbation) versus all others. From 4 to 8 variables were able to differentiate cases from controls, with sensitivity ≥73 (range: 73-90) and specificity >68 (range: 68-93). Across scenarios, the best models included age, smoking status or history, symptoms (cough, wheeze, phlegm), general or breathing-related activity limitation, episodes of acute bronchitis, and/or missed work days and non-work activities due to breathing or health. Results provide insight into variables that should be considered during the development of candidate items for a new questionnaire to identify undiagnosed cases of clinically significant COPD.

Effect of Kuanxiong Aerosol () on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial.

PubMed

Yang, Qiao-Ning; Bai, Rui-Na; Dong, Guo-Ju; Ge, Chang-Jiang; Zhou, Jing-Min; Huang, Li; He, Yan; Wang, Jun; Ren, Ai-Hua; Huang, Zhan-Quan; Zhu, Guang-Li; Lu, Shu; Xiong, Shang-Quan; Xian, Shao-Xiang; Zhu, Zhi-Jun; Shi, Da-Zhuo; Lu, Shu-Zheng; Li, Li-Zhi; Chen, Ke-Ji

2018-05-01

To evaluate the effect and safety of Kuanxiong Aerosol (, KA) on patients with angina pectoris. Block randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1, 2, 3, 4, 5, and >5 min). Logistic regression analysis was performed to observe the factors inflfluencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina. The 5-min remission rates in the KA and control groups were not signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced the rate of remission (95% confidence interval = 0.483-0.740, P<0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly lower in the KA group than in the control group for the CCSII and III subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P<0.05 or P<0.01). KA is not inferior to NT in the remission of angina. Furthermore, in CCSII and III patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTRIPR-15007204).

A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

PubMed Central

2010-01-01

Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302 PMID:20334685

A Systematic Review and Meta-analysis of the Association Between Giardia lamblia and Endemic Pediatric Diarrhea in Developing Countries

PubMed Central

Muhsen, Khitam; Levine, Myron M.

2012-01-01

We performed a systematic literature review and meta-analysis examining the association between diarrhea in young children in nonindustrialized settings and Giardia lamblia infection. Eligible were case/control and longitudinal studies that defined the outcome as acute or persistent (>14 days) diarrhea, adjusted for confounders and lasting for at least 1 year. Data on G. lamblia detection (mainly in stools) from diarrhea patients and controls without diarrhea were abstracted. Random effects model meta-analysis obtained pooled odds ratios (ORs) and 95% confidence intervals (CIs). Twelve nonindustrialized-setting acute pediatric diarrhea studies met the meta-analysis inclusion criteria. Random-effects model meta-analysis of combined results (9774 acute diarrhea cases and 8766 controls) yielded a pooled OR of 0.60 (95% CI, .38–.94; P = .03), indicating that G. lamblia was not associated with acute diarrhea. However, limited data suggest that initial Giardia infections in early infancy may be positively associated with diarrhea. Meta-analysis of 5 persistent diarrhea studies showed a pooled OR of 3.18 (95% CI, 1.50–6.76; P < .001), positively linking Giardia with that syndrome. The well-powered Global Enteric Multicenter Study (GEMS) is prospectively addressing the association between G. lamblia infection and diarrhea in children in developing countries. PMID:23169940

Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design.

PubMed

Schwartz, Lauren M; Halloran, M Elizabeth; Rowhani-Rahbar, Ali; Neuzil, Kathleen M; Victor, John C

2017-01-03

The test-negative design (TND), an epidemiologic method currently used to measure rotavirus vaccine (RV) effectiveness, compares the vaccination status of rotavirus-positive cases and rotavirus-negative controls meeting a pre-defined case definition for acute gastroenteritis. Despite the use of this study design in low-income settings, the TND has not been evaluated to measure rotavirus vaccine effectiveness. This study builds upon prior methods to evaluate the use of the TND for influenza vaccine using a randomized controlled clinical trial database. Test-negative vaccine effectiveness (VE-TND) estimates were derived from three large randomized placebo-controlled trials (RCTs) of monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in sub-Saharan Africa and Asia. Derived VE-TND estimates were compared to the original RCT vaccine efficacy estimates (VE-RCTs). The core assumption of the TND (i.e., rotavirus vaccine has no effect on rotavirus-negative diarrhea) was also assessed. TND vaccine effectiveness estimates were nearly equivalent to original RCT vaccine efficacy estimates. Neither RV had a substantial effect on rotavirus-negative diarrhea. This study supports the TND as an appropriate epidemiologic study design to measure rotavirus vaccine effectiveness in low-income settings. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Is There a Role for Oral or Intravenous Ascorbate (Vitamin C) in Treating Patients With Cancer? A Systematic Review

PubMed Central

Hutton, Brian; Ng, Terry; Shorr, Risa; Clemons, Mark

2015-01-01

Background. Many cancer patients receive supplemental ascorbate (vitamin C) in the belief that it synergizes the anticancer effects of chemotherapy and reduces its toxicity. Methods. A systematic review was performed to evaluate the antitumor effects and toxicity of ascorbate treatment. Medline (1946 to March 2014), EMBASE (1947 to March 2014), and the Cochrane central register (1993 to March 2014) were searched for randomized and observational studies. Results. Of 696 identified records, 61 full-text articles were screened and 34 were included. In total, 5 randomized controlled trials (RCTs) (n = 322), 12 phase I/II trials (n = 287), 6 observational studies (n = 7,599), and 11 case reports (n = 267) were identified. Because of study heterogeneity, no meta-analyses were performed. No RCTs reported any statistically significant improvements in overall or progression-free survival or reduced toxicity with ascorbate relative to control arm. Evidence for ascorbate’s antitumor effects was limited to case reports and observational and uncontrolled studies. Conclusion. There is no high-quality evidence to suggest that ascorbate supplementation in cancer patients either enhances the antitumor effects of chemotherapy or reduces its toxicity. Given the high financial and time costs to patients of this treatment, high-quality placebo-controlled trials are needed. PMID:25601965

Lifestyle Factors and Gender-Specific Risk of Stroke in Adults with Diabetes Mellitus: A Case-Control Study.

PubMed

Guo, Jian; Guan, Tianjia; Shen, Ying; Chao, Baohua; Li, Mei; Wang, Longde; Liu, Yuanli

2018-07-01

The lifestyle interventions are effective preventive measures for stroke in general population, and the stroke risk with lifestyle factors may be modified by gender, health conditions, etc. Therefore, we conducted a case-control study to investigate the gender-specific association between stroke risk and lifestyle factors in adults with diabetes based on the China National Stroke Screening Survey. Structured questionnaires were used to collect demographic data and information regarding lifestyle factors, history of chronic medical conditions, and family history of stroke and the status of treatment. The case group comprised individuals diagnosed with first-ever stroke in 2013-2014 screening period. Their corresponding controls (frequency-matched for age group and urban/rural ratio) were randomly selected from individuals with diabetes without stroke. There were 170 total stroke cases (500 controls) and 152 ischemic stroke cases (456 controls) among men with diabetes, and 183 total stroke cases (549 controls) and 168 ischemic stroke cases (504 controls) among women with diabetes. We found that physical inactivity was significantly associated with increased risk of total stroke (odds ratio [OR] = 1.50, 95% confidence interval [CI] 1.02-2.21) and of ischemic stroke (OR = 1.57, 95% CI 1.04-2.36) in women with diabetes. We found no significant association of smoking, overweight/obesity, or physical inactivity with risk of total or ischemic stroke in men with diabetes. Among the lifestyle factors of smoking, overweight/obesity, and physical inactivity, physical inactivity might increase the risk of total and ischemic stroke in women with diabetes. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Increased Use of Community Medicine Distributors and Rational Use of Drugs in Children Less than Five Years of Age in Uganda Caused by Integrated Community Case Management of Fever

PubMed Central

Kalyango, Joan N.; Lindstrand, Ann; Rutebemberwa, Elizeus; Ssali, Sarah; Kadobera, Daniel; Karamagi, Charles; Peterson, Stefan; Alfven, Tobias

2012-01-01

We compared use of community medicine distributors (CMDs) and drug use under integrated community case management and home-based management strategies in children 6–59 months of age in eastern Uganda. A cross-sectional study with 1,095 children was nested in a cluster randomized trial with integrated community case management (CMDs treating malaria and pneumonia) as the intervention and home-based management (CMDs treating only malaria) as the control. Care-seeking from CMDs was higher in intervention areas (31%) than in control areas (22%; P = 0.01). Prompt and appropriate treatment of malaria was higher in intervention areas (18%) than in control areas (12%; P = 0.03) and among CMD users (37%) than other health providers (9%). The mean number of drugs among CMD users compared with other health providers was 1.6 versus 2.4 in intervention areas and 1.4 versus 2.3 in control areas. Use of CMDs was low. However, integrated community case management of childhood illnesses increased use of CMDs and rational drug use. PMID:23136276

Landscape and Residential Variables Associated with Plague-Endemic Villages in the West Nile Region of Uganda

PubMed Central

MacMillan, Katherine; Enscore, Russell E.; Ogen-Odoi, Asaph; Borchert, Jeff N.; Babi, Nackson; Amatre, Gerald; Atiku, Linda A.; Mead, Paul S.; Gage, Kenneth L.; Eisen, Rebecca J.

2011-01-01

Plague, caused by the bacteria Yersinia pestis, is a severe, often fatal disease. This study focuses on the plague-endemic West Nile region of Uganda, where limited information is available regarding environmental and behavioral risk factors associated with plague infection. We conducted observational surveys of 10 randomly selected huts within historically classified case and control villages (four each) two times during the dry season of 2006 (N = 78 case huts and N = 80 control huts), which immediately preceded a large plague outbreak. By coupling a previously published landscape-level statistical model of plague risk with this observational survey, we were able to identify potential residence-based risk factors for plague associated with huts within historic case or control villages (e.g., distance to neighboring homestead and presence of pigs near the home) and huts within areas previously predicted as elevated risk or low risk (e.g., corn and other annual crops grown near the home, water storage in the home, and processed commercial foods stored in the home). The identified variables are consistent with current ecologic theories on plague transmission dynamics. This preliminary study serves as a foundation for future case control studies in the area. PMID:21363983

A probability model for evaluating the bias and precision of influenza vaccine effectiveness estimates from case-control studies.

PubMed

Haber, M; An, Q; Foppa, I M; Shay, D K; Ferdinands, J M; Orenstein, W A

2015-05-01

As influenza vaccination is now widely recommended, randomized clinical trials are no longer ethical in many populations. Therefore, observational studies on patients seeking medical care for acute respiratory illnesses (ARIs) are a popular option for estimating influenza vaccine effectiveness (VE). We developed a probability model for evaluating and comparing bias and precision of estimates of VE against symptomatic influenza from two commonly used case-control study designs: the test-negative design and the traditional case-control design. We show that when vaccination does not affect the probability of developing non-influenza ARI then VE estimates from test-negative design studies are unbiased even if vaccinees and non-vaccinees have different probabilities of seeking medical care against ARI, as long as the ratio of these probabilities is the same for illnesses resulting from influenza and non-influenza infections. Our numerical results suggest that in general, estimates from the test-negative design have smaller bias compared to estimates from the traditional case-control design as long as the probability of non-influenza ARI is similar among vaccinated and unvaccinated individuals. We did not find consistent differences between the standard errors of the estimates from the two study designs.

Risk factors for mumps at a university with a large mumps outbreak.

PubMed

Huang, Angela S; Cortese, Margaret M; Curns, Aaron T; Bitsko, Rebecca H; Jordan, Hannah T; Soud, Fatma; Villalon-Gomez, Jose; Denning, Patricia M; Ens, Kim A; Hanson, Gail R; Dayan, Gustavo H

2009-01-01

Routine measles-mumps-rubella (MMR) vaccine use has greatly decreased the incidence of mumps in the U.S. However, a resurgence of mumps occurred in 2006. We investigated the large outbreak at a university and assessed risk factors for disease. We described the outbreak and conducted a case-control study. We interviewed case students (identified from student health service and health department records) and control students (selected from a randomly ordered administrative list) and assessed their vaccination status. We compared case students with > or = 2 MMR doses and control students with > or = 2 MMR doses in univariate and multivariate analyses. The mean age of the 174 case students was 20.9 years; 65% were women. Ninety-seven case students and 147 control students were enrolled in the study. Two-dose MMR coverage was 99% among case and control students with complete records. Only 33% of case students reported exposure to someone with mumps. Case students were more likely than control students to be aged 18 to 19 years (vs. aged 22 years, adjusted odds ratio [AOR] = 5.55; 95% confidence interval [CI] 2.09, 14.74), to report exposure to mumps (AOR=2.31, 95% CI 1.13, 4.73), and to have worked/volunteered on campus (AOR=2.91, 95% CI 1.33, 6.33). Also, women in dormitories had increased odds of mumps compared with men in dormitories. High two-dose MMR coverage was not sufficient to prevent the outbreak. Further study is needed to better understand the effects of dormitory residency and gender on mumps transmission. Clinicians should be vigilant for mumps in young adults presenting with parotitis regardless of immunization history.

Direct medical costs of constipation in children over 15 years: a population-based birth cohort

PubMed Central

Choung, Rok Seon; Shah, Nilay D.; Chitkara, Denesh; Branda, Megan E.; Van Tilburg, Miranda A.; Whitehead, William E.; Katusic, Slavica K.; Locke, G. Richard; Talley, Nicholas J.

2011-01-01

Background Although direct medical costs for constipation-related medical visits are thought to be high, to date there have been no studies examining if longitudinal resource utilization is persistently elevated in children with constipation. Our aim was to estimate the incremental direct medical costs and types of health care utilization associated with constipation from childhood to early adulthood. Methods A nested case-control study was conducted to evaluate the incremental costs associated with constipation. The original sample consisted of 5,718 children in a population-based birth cohort who were born during 1976–1982 in Rochester, MN. The cases included individuals who presented to medical facilities with constipation. The controls were matched and randomly selected among all non-cases in the sample. Direct medical costs for cases and controls were collected from the time subjects were between 5–18 years of age or until the subject emigrated from the community. Results We identified 250 cases with a diagnosis of constipation in the birth cohort. While the mean inpatient costs for cases were $9994 (95% CI=2538, 37201) compared to $2391 (95% CI=923, 7452) for controls (p=0.22) over the time period, the mean outpatient costs for cases were $13927 (95% CI=11325, 16525) compared to $3448 (95% CI=3771, 4621) for controls (p<0.001) over the same time period. The mean annual number emergency department visits for cases were 0.66 (95% CI=0.62, 0.70) compared to 0.34 (95% CI=0.32, 0.35) for controls (p<0.0001). Conclusion Individuals with constipation have higher medical care utilization. Outpatient costs and ER utilization were significantly greater for individuals with constipation from childhood to early adulthood. PMID:20890220

A case-control study of acute respiratory tract infection in general practice patients in The Netherlands.

PubMed

van Gageldonk-Lafeber, Arianne B; Heijnen, Marie-Louise A; Bartelds, Aad I M; Peters, Marcel F; van der Plas, Simone M; Wilbrink, Berry

2005-08-15

Acute respiratory tract infections (ARTIs) are responsible for considerable morbidity in the community, but little is known about the presence of respiratory pathogens in asymptomatic individuals. We hypothesized that asymptomatic persons could have a subclinical infection and thus act as a source of transmission. During the period of 2000-2003, all patients with ARTI who visited their sentinel general practitioner had their data reported to estimate the incidence of ARTI in Dutch general practices. A random selection of these patients (case patients) and an equal number of asymptomatic persons visiting for other complaints (control subjects) were included in a case-control study. Nose and throat swabs of participants were tested for a broad range of pathogens. The overall incidence of ARTI was 545 cases per 10,000 person-years, suggesting that, in the Dutch population, an estimated 900,000 persons annually consult their general practitioner for respiratory complaints. Rhinovirus was most common in case patients (24%), followed by influenza virus type A (11%) and coronavirus (7%). Viruses were detected in 58% of the case patients, beta -hemolytic streptococci group A were detected in 11%, and mixed infections were detected in 3%. Pathogens were detected in approximately 30% of control subjects, particularly in the youngest age groups. This study confirms that most ARTIs are viral and supports the reserved policy of prescribing antibiotics. In both case and control subjects, rhinovirus was the most common pathogen. Of bacterial infections, only group A beta-hemolytic streptococci were more common in case patients than in control subjects. Furthermore, we demonstrated that asymptomatic persons might be a neglected source of transmission.

Shigellosis Outbreak Associated with Contaminated Well Water in a Rural Elementary School: Sichuan Province, China, June 7–16, 2009

PubMed Central

Sun, Wei; Zhang, Lijie; Zhu, Baoping; Ma, Huilai

2012-01-01

Objectives We investigated a shigellosis outbreak in an elementary school to identify the source of infection, mode of transmission and risk factors for illness. Methods In a case-control investigation, we compared the source of drinking water, consumption of untreated well water and suspected food items, and hygienic habits between case-students and randomly selected asymptomatic control-students, frequency-matched by class on a 1∶1 ratio. Results 18% of the 533 students and no teachers developed Shigella. 52%(44/85) of case-students and 17% (12/71) of control-students drank untreated well water (OR = 2.3, 95% CI = 1.1–5.8); 47% (n = 40/85) of case-students and 14% (10/71) of control-students drank untreated water from Well A (OR = 3.7, 95% CI = 1.3–11). The odds ratio increased with the amount of untreated Well A water consumed (p = 0.035, χ2 test for trend). Rectal swabs from 5 of 6 case-students and water from Well A yielded Shigella flexneri 2b. Conclusions This shigellosis outbreak was caused by drinking untreated water from a well polluted by Shigella flexneri 2b. PMID:23071767

The Effects of Body Acupuncture on Obesity: Anthropometric Parameters, Lipid Profile, and Inflammatory and Immunologic Markers

PubMed Central

Abdi, Hamid; Zhao, Baixiao; Darbandi, Mahsa; Ghayour-Mobarhan, Majid; Tavallaie, Shima; Rahsepar, Amir Ali; Parizadeh, Seyyed Mohammad Reza; Safariyan, Mohammad; Nemati, Mohsen; Mohammadi, Maryam; Abbasi-Parizad, Parisa; Darbandi, Sara; Akhlaghi, Saeed; Ferns, Gordon A. A.

2012-01-01

A randomized controlled clinical trial in 196 obese subjects was performed to examine the effectiveness of body acupuncture on body weight loss, lipid profile and immunogenic and inflammatory markers. Subjects received authentic (cases) or sham (controls) acupuncture for 6 weeks in combination with a low-calorie diet. In the following 6 weeks, they received the low-calorie diet alone. Subjects were assessed at the beginning, 6 and 12 weeks later. Heat shock protein (Hsps)-27, 60, 65, 70 antibody titers and high sensitivity C-reactive protein (hs-CRP) levels were also assessed. A significant reduction in measures of adiposity and improvement in lipid profile were observed in both groups, but the levels of anti-Hsp-antibodies decreased in cases only. A reduction in anthropometric and lipid profile in cases were sustained in the second period, however, only changes in lipid profile were observed in the control group. Anti-Hsp-antibodies and hs-CRP levels continued to be reduced in cases but in controls only the reduction in hs-CRP remained. Changes in anthropometric parameters, lipid profile, and anti-Hsp-antibodies were more evident in cases. Body acupuncture in combination with diet restriction was effective in enhancing weight loss and improving dyslipidemia. PMID:22649299

Random-access algorithms for multiuser computer communication networks. Doctoral thesis, 1 September 1986-31 August 1988

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

Papantoni-Kazakos, P.; Paterakis, M.

1988-07-01

For many communication applications with time constraints (e.g., transmission of packetized voice messages), a critical performance measure is the percentage of messages transmitted within a given amount of time after their generation at the transmitting station. This report presents a random-access algorithm (RAA) suitable for time-constrained applications. Performance analysis demonstrates that significant message-delay improvement is attained at the expense of minimal traffic loss. Also considered is the case of noisy channels. The noise effect appears at erroneously observed channel feedback. Error sensitivity analysis shows that the proposed random-access algorithm is insensitive to feedback channel errors. Window Random-Access Algorithms (RAAs) aremore » considered next. These algorithms constitute an important subclass of Multiple-Access Algorithms (MAAs); they are distributive, and they attain high throughput and low delays by controlling the number of simultaneously transmitting users.« less

The informational architecture of the cell.

PubMed

Walker, Sara Imari; Kim, Hyunju; Davies, Paul C W

2016-03-13

We compare the informational architecture of biological and random networks to identify informational features that may distinguish biological networks from random. The study presented here focuses on the Boolean network model for regulation of the cell cycle of the fission yeast Schizosaccharomyces pombe. We compare calculated values of local and global information measures for the fission yeast cell cycle to the same measures as applied to two different classes of random networks: Erdös-Rényi and scale-free. We report patterns in local information processing and storage that do indeed distinguish biological from random, associated with control nodes that regulate the function of the fission yeast cell-cycle network. Conversely, we find that integrated information, which serves as a global measure of 'emergent' information processing, does not differ from random for the case presented. We discuss implications for our understanding of the informational architecture of the fission yeast cell-cycle network in particular, and more generally for illuminating any distinctive physics that may be operative in life. © 2016 The Author(s).

A randomized trial of automated electronic alerts demonstrating improved reimbursable anesthesia time documentation.

PubMed

Freundlich, Robert E; Barnet, Caryn S; Mathis, Michael R; Shanks, Amy M; Tremper, Kevin K; Kheterpal, Sachin

2013-03-01

To investigate whether alerting providers to errors results in improved documentation of reimbursable anesthesia care. Prospective randomized controlled trial. Operating room (OR) of a university hospital. Anesthesia cases were evaluated to determine whether they met the definition for appropriate anesthesia start time over 4 separate, 45-day calendar cycles: the pre-study period, study period, immediate post-study period, and 3-year follow-up period. During the study period, providers were randomly assigned to either a control or an alert group. Providers in the alert cohort received an automated alphanumeric page if the anesthesia start time occurred concurrently with the patient entering the OR, or more than 30 minutes before entering the OR. Three years after the intervention period, overall compliance was analyzed to assess learned behavior. Baseline compliance was 33% ± 5%. During the intervention period, providers in the alert group showed 87% ± 6% compliance compared with 41% ± 7% compliance in the control group (P < 0.001). Long-term follow-up after cessation of the alerts showed 85% ± 4% compliance. Automated electronic reminders for time-based billing charges are effective and result in improved ongoing reimbursement. Copyright © 2013 Elsevier Inc. All rights reserved.

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

PubMed

McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

Facilitating Case Studies in Massage Therapy Clinical Education

PubMed Central

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Internet Telehealth for Pediatric Asthma Case Management: Integrating Computerized and Case Manager Features for Tailoring a Web-Based Asthma Education Program

PubMed Central

Wise, Meg; Gustafson, David H.; Sorkness, Christine A.; Molfenter, Todd; Staresinic, Anthony; Meis, Tracy; Hawkins, Robert P.; Shanovich, Kathleen Kelly; Walker, Nola P.

2008-01-01

This article reports on the development of a personalized, Web-based asthma-education program for parents whose 4- to 12-year-old children have moderate to severe asthma. Personalization includes computer-based tailored messages and a human coach to build asthma self-management skills. Computerized features include the Asthma Manager, My Calendar/Reminder, My Goals, and a tailored home page. These are integrated with monthly asthma-education phone calls from an asthmanurse case manager. The authors discuss the development process and issues and describe the current randomized evaluation study to test whether the yearlong integrated intervention can improve adherence to a daily asthma controller medication, asthma control, and parent quality of life to reduce asthma-related healthcare utilization. Implications for health education for chronic disease management are raised. PMID:16928987

Improvements To Progressive Wave Tube Performance Through Closed-Loop Control

NASA Technical Reports Server (NTRS)

Rizzi, Stephen A.

2000-01-01

This report documents recent improvements to the acoustic and thermal control systems of the Thermal Acoustic Fatigue Apparatus (TAFA), a progressive wave tube test facility at the NASA Langley Research Center, Hampton, Virginia. A brief summary of past acoustic performance is given first to serve as a basis for comparison with the new performance data using a multiple-input, closed-loop, narrow-band controller. Performance data in the form of test section acoustic power spectral densities and coherence are presented in three of six facility configurations for a variety of input spectra. Tested spectra include uniform, two cases of pink noise, three cases of narrow-band random, a simulated launch payload bay environment for an expendable launch vehicle, and a simulated external acoustic load for the aft section of a reusable launch vehicle. In addition, a new closed-loop temperature controller and thermocouple data acquisition system are described.

The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study

PubMed Central

Boisseau, Christina L.; Farchione, Todd J.; Fairholme, Christopher P.; Ellard, Kristen K.; Barlow, David H.

2013-01-01

A detailed description of treatment utilizing the Unified Protocol (UP), a transdiagnostic emotion-focused cognitive-behavioral treatment, is presented using a clinical case example treated during the most current phase of an ongoing randomized controlled trial of the UP. The implementation of the UP in its current, modular version is illustrated. A working case conceptualization is presented from the perspective of the UP drawing from theory and research that underlies current transdiagnostic approaches to treatment and consistent with recent dimensional classification proposals (Brown & Barlow, in press). Treatment is illustrated module-by-module describing how the principles of the UP were applied in the presented case. PMID:23997572

Propranolol reduces the anxiety associated with day case surgery.

PubMed

Mealy, K; Ngeh, N; Gillen, P; Fitzpatrick, G; Keane, F B; Tanner, A

1996-01-01

To find out if propranolol, a non-cardioselective beta-blocker, can reduce the anxiety associated with day case surgery. Prospective randomized double blind trial. University hospital, Ireland. An unselected group of 53 patients undergoing day case surgery. Subjects randomised to receive either propranolol (10 mg) or placebo on the morning of operation. Blood pressure; pulse, anxiety, pain score and patient satisfaction. Mean (SD) Hospital Anxiety and Depression score was significantly lower in the propranolol group than in the control group (2.5 (0.7) compared with 4.6 (0.7), p < 0.0001) before discharge. A low dose of propranolol given on the morning of day case surgery significantly reduced patients' anxiety.

Honey as a dressing for chronic wounds in adults.

PubMed

Fox, Carolyn

2002-10-01

The aim of this review was to identify whether in adults with chronic wounds the use of honey as a wound dressing improves wound management outcomes. As no randomized controlled trials or comparative studies comparing the use of honey as a chronic wound dressing with usual treatment could be found, the review is based on case studies and serial case studies. These were reviewed using a framework broadly based on wound care case study guidelines (Nelson, 2000) and cohort study guidelines (Greenhalgh and Donald, 2000). Based on the case studies reviewed, honey appears to be a useful dressing in adults with chronic wounds, but the available evidence is weak and therefore must be interpreted with caution.

A large multi-pathogen gastroenteritis outbreak caused by drinking contaminated water from antique neighbourhood fountains, Erzurum city, Turkey, December 2012.

PubMed

Sezen, F; Aval, E; Ağkurt, T; Yilmaz, Ş; Temel, F; Güleşen, R; Korukluoğlu, G; Sucakli, M B; Torunoğlu, M A; Zhu, B-P

2015-03-01

We investigated a gastroenteritis outbreak in Erzurum city, Turkey in December 2012 to identify its cause and mode of transmission. We defined a probable case as onset of diarrhoea (⩾3 episodes/day) or vomiting, plus fever or nausea or abdominal pain during 19-27 December, 2012 in an Erzurum city resident. In a case-control study we compared exposures of 95 randomly selected probable cases and 95 neighbourhood-matched controls. We conducted bacterial culture and real-time multiplex PCR for identification of pathogens. During the week before illness onset, 72% of cases and 15% of controls only drank water from antique neighbourhood fountains; conversely, 16% of cases and 65% of controls only drank bottled or tap water (adjusted odds ratio 20, 95% confidence interval 4·6-84, after controlling for age and sex using conditional logistic regression). Of eight stool specimens collected, two were positive for Shigella sonnei, one for astrovirus, one for astrovirus and norovirus, and one for astrovirus and rotavirus. Water samples from the fountains had elevated total coliform (38-300/100 ml) and Escherichia coli (22-198/100 ml) counts. In conclusion, drinking contaminated fountain water caused this multi-pathogen outbreak. Residents should stop drinking water from these fountains, and clean water from the water treatment plant should be connected to the fountains.

Hypertension and the risk of endometrial cancer: a systematic review and meta-analysis of case-control and cohort studies.

PubMed

Aune, Dagfinn; Sen, Abhijit; Vatten, Lars J

2017-04-07

A history of hypertension has been associated with increased risk of endometrial cancer in several studies, but the results have not been consistent. We conducted a systematic review and meta-analysis of case-control and cohort studies to clarify the association between hypertension and endometrial cancer risk. PubMed and Embase databases were searched up to 27 th of February 2016. Prospective and case-control studies which reported adjusted relative risk estimates and 95% confidence intervals of endometrial cancer associated with a hypertension diagnosis were included. Summary relative risks were estimated using a random effects model. Nineteen case-control studies and 6 cohort studies were included. The summary RR was 1.61 (95% CI: 1.41-1.85, I 2  = 86%) for all studies, 1.73 (95% CI: 1.45-2.06, I 2  = 89%) for case-control studies and 1.32 (95% CI: 1.12-1.56, I 2  = 47%) for cohort studies. The association between hypertension and endometrial cancer was weaker, but still significant, among studies with adjustment for smoking, BMI, oral contraceptive use, and parity, compared to studies without such adjustment. This meta-analysis suggest an increased risk of endometrial cancer among patients with hypertension, however, further studies with more comprehensive adjustments for confounders are warranted to clarify the association.

[The analyse of telephone follow-up affecting the compliance of sublingual desensitization treatment to allergic rhinitis patients].

PubMed

Cui, Long; Wang, Zhinan; Xu, Zhongqiang; Xia, Zhongfang; Zhang, Yamin; Huang, Fang

2011-04-01

To analyze the compliance of sublingual desensitization used in allergic rhinitis patients by telephone follow up, and to discuss the influencing factor associate with medicine pause. One hundred and thirty-two patients of allergic rhinitis were randomly divided into two groups, 53 cases was in the control group, 79 cases was in telephone follow up group for a period of 6 months of observation. Sublingual desensitization treatment for 6 months, 28/53 cases of control group were compliance, 25/53 cases were loss, and compliance rate was 52.8%; 17/27 cases of follow-up group A were compliance, 10/27 cases were loss, and compliance rate was 63.0%; 21/28 cases of follow-up group B were compliance, 7/28 cases were loss, and compliance rate was 75.0%; 22/24 of follow-up group C were compliance, 2/24 cases were loss, and compliance rate was 91.7% (P < 0.05). Significant difference was found in the 4th month after treatment (P < 0.01). Long-term treatment and cure were the main impact factors for compliance. Timely telephone follow-up education and guidance to patients could improve compliance of patients with sublingual desensitization.

A Randomized, Controlled Trial of Meditation for Work Stress, Anxiety and Depressed Mood in Full-Time Workers

PubMed Central

Manocha, R.; Black, D.; Sarris, J.; Stough, C.

2011-01-01

Objective. To assess the effect of meditation on work stress, anxiety and mood in full-time workers. Methods. 178 adult workers participated in an 8-week, 3-arm randomized controlled trial comparing a “mental silence” approach to meditation (n = 59) to a “relaxation” active control (n = 56) and a wait-list control (n = 63). Participants were assessed before and after using Psychological Strain Questionnaire (PSQ), a subscale of the larger Occupational Stress Inventory (OSI), the State component of the State/Trait Anxiety Inventory for Adults (STAI), and the depression-dejection (DD) subscale of the Profile of Mood States (POMS). Results. There was a significant improvement for the meditation group compared to both the relaxation control and the wait-list groups the PSQ (P = .026), and DD (P = .019). Conclusions. Mental silence-orientated meditation, in this case Sahaja Yoga meditation, is a safe and effective strategy for dealing with work stress and depressive feelings. The findings suggest that “thought reduction” or “mental silence” may have specific effects relevant to work stress and hence occupational health. PMID:21716708

Effects of Weighted Vests on Classroom Behavior for Children with Autism and Cognitive Impairments

ERIC Educational Resources Information Center

Hodgetts, Sandra; Magill-Evans, Joyce; Misiaszek, John

2011-01-01

This randomized controlled single-case study investigated the effects of weighted vests for 10 children with autism in a classroom setting. Blinded observers rated targeted behaviors through video taken during structured table-top activities typically part of the classroom routine. Blinded teachers rated each child's behavior with the Conners'…

Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

2016-01-01

Purpose: Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early…

Single-Case Experimental Designs in Educational Research: A Methodology for Causal Analyses in Teaching and Learning

ERIC Educational Resources Information Center

Plavnick, Joshua B.; Ferreri, Summer J.

2013-01-01

Current legislation requires educational practices be informed by science. The effort to establish educational practices supported by science has, to date, emphasized experiments with large numbers of participants who are randomly assigned to an intervention or control condition. A potential limitation of such an emphasis at the expense of other…

Nitrates in drinking water and risk of death from rectal cancer in Taiwan.

PubMed

Kuo, Hsin-Wei; Wu, Trong-Neng; Yang, Chun-Yuh

2007-10-01

The relationship between nitrate levels in drinking water and rectal cancer development has been inconclusive. A matched case-control and nitrate ecology study was used to investigate the association between mortality attributed to rectal cancer and drinking-water nitrate exposure in Taiwan. All deaths due to rectal cancer of Taiwan residents from 1999 through 2003 were obtained from the Bureau of Vital Statistics of the Taiwan Provincial Department of Health. Controls were deaths from other causes and were pair matched to the cancer cases by gender, year of birth, and year of death. Each matched control was selected randomly from the set of possible controls for each case. Data on nitrate-nitrogen (NO3-N) levels in drinking water throughout Taiwan were collected from Taiwan Water Supply Corporation (TWSC). The municipality of residence for cancer cases and controls was assumed to be the source of the subject's nitrate exposure via drinking water. The adjusted odds ratios for rectal cancer death for those with high nitrate levels in their drinking water, as compared to the lowest tertile, were 1.22 (0.98-1.52) and 1.36 (1.08-1.70), respectively. The findings of this study warrant further investigation of the role of nitrates in drinking water in the etiology of rectal cancer in Taiwan.

Lifestyle risk factors for intrahepatic stone: findings from a case-control study in an endemic area, Taiwan.

PubMed

Momiyama, Masato; Wakai, Kenji; Oda, Koji; Kamiya, Junichi; Ohno, Yoshiyuki; Hamaguchi, Michinari; Nakanuma, Yasuni; Hsieh, Ling-Ling; Yeh, Ta-Sen; Chen, Tse-Ching; Jan, Yi-Yi; Chen, Miin-Fu; Nimura, Yuji

2008-07-01

To examine associations between lifestyle risk factors and intrahepatic stone (IHS), we conducted a case-control study in Taiwan, which has the highest incidence of IHS in the world. Study subjects were 151 patients newly diagnosed with IHS at Chang Gung Memorial Hospital between January 1999 and December 2001. Two control subjects per case were selected randomly from patients who underwent minor surgery at the same hospital and from family members or neighbors of the hospital staff. Controls were matched to each case by age and gender. Information on lifestyle factors was collected using a self-administered questionnaire. Strength of associations was assessed using odds ratios derived from conditional logistic models. Female patients were significantly shorter than female controls. Compared to subjects with two or fewer children, odds ratios for those with six or more children were 20.4 in men (95% confidence interval, 1.89-221) and 2.82 (0.97-8.22) in women. Increasing level of education lowered the risk of intrahepatic stone (trend P = 0.004 for men and < 0.0001 for women). Women who had consumed ground-surface water for a long period had a somewhat increased risk (trend P = 0.05). Lower socioeconomic status and poor hygiene may be involved in the development of intrahepatic stones.

Improved quality monitoring of multi-center acupuncture clinical trials in China

PubMed Central

2009-01-01

Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs). Methods A standard quality control program (QCP) was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture. PMID:20035630

A randomized controlled open trial of population-based disease and case management in a Medicare Plus Choice health maintenance organization.

PubMed

Martin, David C; Berger, Marc L; Anstatt, David T; Wofford, Jonathan; Warfel, DeAnn; Turpin, Robin S; Cannuscio, Carolyn C; Teutsch, Steven M; Mansheim, Bernard J

2004-10-01

The object of this study was to examine the effect of population-based disease management and case management on resource use, self-reported health status, and member satisfaction with and retention in a Medicare Plus Choice health maintenance organization (HMO). Study design consisted of a prospective, randomized controlled open trial of 18 months' duration. Participants were 8504 Medicare beneficiaries aged 65 and older who had been continuously enrolled for at least 12 months in a network model Medicare Plus Choice HMO serving a contiguous nine-county metropolitan area. Members were care managed with an expert clinical information system and frequent telephone contact. Main outcomes included self-reported health status measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), resource use measured by admission rates and bed-days per thousand per year, member satisfaction, and costs measured by paid claims. More favorable outcomes occurred in the intervention group for satisfaction with the health plan (P < .01) and the social function domain as measured by SF-36 (P = .04). There was no difference in member retention or mortality between groups. Use of skilled nursing home services was significantly lower in the intervention group than in the control (616 vs 747 days per thousand members per year, P = .02). This reduction, however, did not lead to lower mean total expenditures in the intervention group compared with the control (6828 dollars per member for 18 months vs 7001 dollars, P = .61). Population-based disease management and case management led to improved self-reported satisfaction and social function but not to a global net decrease in resource use or improved member retention.

Cognition, academic achievement, and epilepsy in school-age children: a case-control study in a developing country.

PubMed

Melbourne Chambers, R; Morrison-Levy, N; Chang, S; Tapper, J; Walker, S; Tulloch-Reid, M

2014-04-01

We conducted a case-control study of 33 Jamaican children 7 to 12years old with uncomplicated epilepsy and 33 of their classroom peers matched for age and gender to determine whether epilepsy resulted in differences in cognitive ability and school achievement and if socioeconomic status or the environment had a moderating effect on any differences. Intelligence, language, memory, attention, executive function, and mathematics ability were assessed using selected tests from NEPSY, WISCR, TeaCh, WRAT3 - expanded, and Raven's Coloured Progressive Matrices. The child's environment at home was measured using the Middle Childhood HOME inventory. Socioeconomic status was determined from a combination of household, crowding, possessions, and sanitation. We compared the characteristics of the cases and controls and used random effects regression models (using the matched pair as the cluster) to examine the relationship between cognition and epilepsy. We found that there was no significant difference in IQ, but children with epilepsy had lower scores on tests of memory (p<0.05), language (p<0.05), and attention (p<0.01) compared with their controls. In random effects models, epilepsy status had a significant effect on memory (coefficient=-0.14, CI: -0.23, -0.05), language (coefficient=-0.13, CI: -0.23, -0.04), and mathematics ability (coefficient=-0.01, CI: -0.02, -0.00). Adjustment for the home environment and socioeconomic status and inclusion of interaction terms for these variables did not alter these effects. In conclusion, we found that epilepsy status in Jamaican children has a significant effect on performance on tests of memory, language, and mathematics and that this effect is not modified or explained by socioeconomic status or the child's home environment. Copyright © 2014 Elsevier Inc. All rights reserved.

Methylene blue intra-arterial staining of resected colorectal cancer specimens improves accuracy of nodal staging: A randomized controlled trial.

PubMed

Reima, H; Saar, H; Innos, K; Soplepmann, J

2016-11-01

Metastatic involvement of regional lymph nodes is a major prognostic factor of colorectal cancer, which influences also its treatment strategy. International consensus foresees retrieval of ≥12 lymph nodes from colorectal specimens. The aim of the study was to assess the effect of intra-arterial staining of colorectal specimens with methylene blue on lymph node harvest. A total of 266 radically operated colorectal cancer patients were randomized into the methylene blue staining and non-staining groups. In the staining group, methylene blue solution was injected into the colorectal specimen's artery after its removal. The specimens were analysed for lymph node count, diameter and metastatic involvement. The median number of lymph nodes was higher in the staining group, 27 (95% CI 23-31%), compared with the control group, 16 (95% CI 14-19, p < 0.001). The number of examined lymph-nodes was ≥12 in 86% of the cases in the staining group and in 69% of the cases in the control group (p = 0.001). In the staining group more small-diameter (≤4 mm) lymph nodes were examined (median number 20.5 vs. 10, p < 0.001). The proportion of patients with metatatic lymph nodes was 42% in the staining group and 43% in the control group (NS). Methylene blue staining improves significantly staging accuracy through finding more small-diameter lymph nodes. It enables to detect ≥12 lymph nodes in the majority of cases. We recommend routine use of this technique in all colorectal resections with curative intent. Copyright © 2016 Elsevier Ltd, BASO ~ the Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

Reduction in the Incidence of Influenza A but Not Influenza B Associated with Use of Hand Sanitizer and Cough Hygiene in Schools: A Randomized Controlled Trial

PubMed Central

STEBBINS, SAMUEL; CUMMINGS, DEREK A.T.; STARK, JAMES H.; VUKOTICH, CHUCK; MITRUKA, KIREN; THOMPSON, WILLIAM; RINALDO, CHARLES; ROTH, LOREN; WAGNER, MICHAEL; WISNIEWSKI, STEPHEN R.; DATO, VIRGINIA; ENG, HEATHER; BURKE, DONALD S.

2012-01-01

Background Laboratory-based evidence is lacking regarding the efficacy of non-pharmaceutical interventions such as alcohol-based hand sanitizer and respiratory hygiene to reduce the spread of influenza. Methods The Pittsburgh Influenza Prevention Project was a cluster-randomized trial conducted in ten Pittsburgh, PA elementary schools during the 2007-2008 influenza season. Children in five intervention schools received training in hand and respiratory hygiene, and were provided and encouraged to use hand sanitizer regularly. Children in five schools acted as controls. Children with influenza-like illness were tested for influenza A and B by RT-PCR. Results 3360 children participated. Using RT-PCR, 54 cases of influenza A and 50 cases of influenza B were detected. We found no significant effect of the intervention on the primary study outcome of all laboratory confirmed influenza cases (IRR 0.81 95% CI 0.54, 1.23). However, we did find statistically significant differences in protocol-specified ancillary outcomes. Children in intervention schools had significantly fewer laboratory-confirmed influenza A infections than children in control schools, with an adjusted IRR of 0.48 (95% CI 0.26, 0.87). Total absent episodes were also significantly lower among the intervention group than among the control group; adjusted IRR 0.74 (95% CI 0.56, 0.97). Conclusions Non-pharmaceutical interventions (respiratory hygiene education and the regular use of hand sanitizer) did not reduce total laboratory confirmed influenza. However the interventions did reduce school total absence episodes by 26% and laboratory-confirmed influenza A infections by 52%. Our results suggest that NPIs can be an important adjunct to influenza vaccination programs to reduce the number of influenza A infections among children. PMID:21691245

Effect of Testosterone Treatment on Adipokines and Gut Hormones in Obese Men on a Hypocaloric Diet.

PubMed

Ng Tang Fui, Mark; Hoermann, Rudolf; Grossmann, Mathis

2017-04-01

In obese men with lowered testosterone levels, testosterone treatment augments diet-associated loss of body fat. We hypothesized that testosterone treatment modulates circulating concentrations of hormonal mediators of fat mass and energy homeostasis in obese men undergoing a weight loss program. Prespecified secondary analysis of a randomized, double-blind, placebo-controlled trial. Tertiary referral center. Obese men (body mass index ≥30 kg/m 2 ) with a repeated total testosterone level ≤12 nmol/L. One hundred participants mean age 53 years (interquartile range 47 to 60 years) receiving 10 weeks of a very low-energy diet followed by 46 weeks of weight maintenance were randomly assigned at baseline to 56 weeks of intramuscular testosterone undecanoate (cases, n = 49) or matching placebo (controls, n = 51). Eighty-two men completed the study. Between-group differences in leptin, adiponectin, ghrelin, glucagon like peptide-1, gastric inhibitory polypeptide, peptide YY, pancreatic polypeptide, and amylin levels. At study end, compared with controls, cases had greater reductions in leptin [mean adjusted difference (MAD), -3.6 ng/mL (95% CI, -5.3 to -1.9); P < 0.001]. The change in leptin levels between cases and controls was dependent on baseline fat mass, as the between-group difference progressively increased with increasing fat mass [MAD, -0.26 ng/mL (95% CI, -0.31 to -0.26); P = 0.001 per 1 kg of baseline fat mass]. Weight loss-associated changes in other hormones persisted during the weight maintenance phase but were not modified by testosterone treatment. Testosterone treatment led to reductions in leptin beyond those achieved by diet-associated weight loss. Testosterone treatment may reduce leptin resistance in obese men.

Soft tissue cell adhesion to titanium abutments after different cleaning procedures: Preliminary results of a randomized clinical trial

PubMed Central

Canullo, Luigi; Peñarrocha-Oltra, David; Marchionni, Silvia; Bagán, Leticia; Micarelli, Costanza

2014-01-01

Objectives: A randomized controlled trial was performed to assess soft tissue cell adhesion to implant titanium abutments subjected to different cleaning procedures and test if plasma cleaning can enhance cell adhesion at an early healing time. Study Design: Eighteen patients with osseointegrated and submerged implants were included. Before re-opening, 18 abutments were divided in 3 groups corresponding to different clinical conditions with different cleaning processes: no treatment (G1), laboratory customization and cleaning by steam (G2), cleaning by plasma of Argon (G3). Abutments were removed after 1 week and scanning electron microscopy was used to analyze cell adhesion to the abutment surface quantitatively (percentage of area occupied by cells) and qualitatively (aspect of adhered cells and presence of contaminants). Results: Mean percentages of area occupied by cells were 17.6 ± 22.7%, 16.5 ± 12.9% and 46.3 ± 27.9% for G1, G2 and G3 respectively. Differences were statistically significant between G1 and G3 (p=0.030), close to significance between G2 and G3 (p=0.056), and non-significant between G1 and G2 (p=0.530). The proportion of samples presenting adhered cells was homogeneous among the 3 groups (p-valor = 1.000). In all cases cells presented a flattened aspect; in 2 cases cells were less efficiently adhered and in 1 case cells presented filipodia. Three cases showed contamination with cocobacteria. Conclusions: Within the limits of the present study, plasma of Argon may enhance cell adhesion to titanium abutments, even at the early stage of soft tissue healing. Further studies with greater samples are necessary to confirm these findings. Key words:Connective tissue, dental abutments, randomized controlled trial, clinical research, glow discharged abutment, plasma cleaning. PMID:24121917

[Effects of Ginkgo biloba extract in improving episodic memory of patients with mild cognitive impairment: a randomized controlled trial].

PubMed

Zhao, Ming-xing; Dong, Zhen-hua; Yu, Zhong-hai; Xiao, Shi-yuan; Li, Ya-ming

2012-06-01

Mild cognitive impairment is a transitional stage between normal aging and dementia. It is important in terms of recognizing memory loss in older people as well as identifying a group of individuals at high risk of developing dementia and who may benefit from preventive strategies. Ginkgo biloba extract has been shown to possess polyvalent properties, such as anti-oxidation, anti-apoptosis and anti-inflammation. Ginkgo biloba extract appears to have a neuroprotective effect against neurodegenerative diseases. To observe the efficacy of Ginkgo biloba leaf tablet in improving episodic memory of mild cognitive impairment. This is a multicenter, randomized, controlled trial. The authors enrolled generally healthy, ambulatory or ambulatory-aided amnestic subjects with MCI, 60 to 85 years old, who expressed a memory complaint from Huadong Hospital, seven Community Health Centers in Shanghai, and Shanghai First Welfare Institution. A total of 120 MCI patients were randomly assigned to the Ginkgo biloba leaf tablet group (treatment group, 60 cases) and control group (60 cases). The patients in the treatment group took Ginkgo biloba leaf tablets 3 times a day, 19.2 mg each dose. The control group did not receive any intelligence-promoting or vasodilator reflex treatment except some health care. The patients were tested with nonsense picture recognition of the clinical memory scale and the logical memory test based on the Wechsler memory scale before and after treatment. After 6 months of treatment, the scores of the logical memory test and nonsense picture recognition were increased significantly in the treatment group (P<0.01, P<0.05), while the scores of the two tests from the control group had no statistically significant difference (P>0.05). After treatment, the positive rate of nonsense picture recognition was 55.17% in the treatment group, which was significantly higher than that of the control group at 32.73% (P<0.05). The efficacy rate of logical memory was 58.62% in the treatment group, also higher than 38.18% in the control group (P<0.05). Ginkgo biloba leaf tablet showed good efficacy in promoting episodic memory function in MCI patients.

Occupational risk factors for Wilms' tumor

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

Bunin, G.; Kramer, S.; Nass, C.

A matched case-control study of Wilms' tumor investigated parental occupational risk factors. Cases diagnosed in 1970-1983 were identified through a population-based tumor registry and hospital registries in the Greater Philadelphia area. Controls were selected by random digit dialing and were matched to cases on race, birth date (+/- 3 years), and the area code and exchange of the case's telephone number at diagnosis. Parents of 100 matched pairs were interviewed by telephone. Parents of patients and controls were generally similar in demographic characteristics, except that mothers differed in religion. Published schemes were used to group jobs into clusters of similarmore » exposures and to determine exposures from industry and job title. Analyses were done for preconception, pregnancy, and postnatal time periods. More case than control fathers had jobs in a cluster that includes machinists and welders (odds ratios (ORs) = 4.0-5.7, p less than or equal to 0.04). Paternal exposures to lead, silver, tin, and iron (some exposures of this cluster) were associated with Wilms' tumor in some analyses, with moderate odds ratios (ORs = 1.5-3.4). In general, the highest odds ratios were found for the preconception period among the genetic (prezygotic) cases. No maternal job clusters or exposures gave significantly elevated odds ratios. These results support a previous finding that lead is a risk factor, but not radiation, hydrocarbon, or boron exposures.« less

Fibromyalgia: epidemiology and risk factors, a population-based case-control study in Lebanon.

PubMed

Moukaddem, Afaf; Chaaya, Monique; Slim, Zeinab F N; Jaffa, Miran; Sibai, Abla Mehio; Uthman, Imad

2017-02-01

To investigate the epidemiology of fibromyalgia (FM) and assess its risk factors. Using data from the 2009 Community Oriented Program for Control of Rheumatic Diseases (COPCORD) study conducted in Lebanon, a population-based case control study was performed. The sample included 34 FM patients, frequency matched with 136 controls free from any musculoskeletal complaints and randomly sampled from the population. The controls were frequency matched with cases by age and gender. The 34 female FM cases were prevalent cases which existed for a long period of time and all those who consulted a doctor were previously misdiagnosed. Family history of joint problems (OR = 4.93, 95% CI: 1.56-15.58) and working status (OR = 2.69, 95% CI: 1.04-6.93) were significant risk factors for FM, after adjusting for body mass index, distress level, smoking status and residence location. This was the first study to address the epidemiology of FM in Lebanon and the region. The chronic nature of FM that is characterized by frequent bouts of intense disabling pain and symptoms constitutes a significant health and economic burden. Clustering of cases in coastal areas was partially explained by other factors such as body mass index, distress level, smoking and work status. The high burden of FM found in our study calls for further investigation of potential risk factors of this condition. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Opt-out screening strategy for HIV infection among patients attending emergency departments: systematic review and meta-analysis.

PubMed

Henriquez-Camacho, C; Villafuerte-Gutierrez, P; Pérez-Molina, J A; Losa, J; Gotuzzo, E; Cheyne, N

2017-07-01

International health agencies have promoted nontargeted universal (opt-out) HIV screening tests in different settings, including emergency departments (EDs). We performed a systematic review and meta-analysis to assess the testing uptake of strategies (opt-in targeted, opt-in nontargeted and opt-out) to detect new cases of HIV infection in EDs. We searched the Pubmed and Embase databases, from 1984 to April 2015, for opt-in and opt-out HIV diagnostic strategies used in EDs. Randomized controlled or quasi experimental studies were included. We assessed the percentage of positive individuals tested for HIV infection in each programme (opt-in and opt-out strategies). The mean percentage was estimated by combining studies in a random-effect meta-analysis. The percentages of individuals tested in the programmes were compared in a random-effect meta-regression model. Data were analysed using stata version 12. Quality assessments were performed using the Newcastle-Ottawa Scale. Of the 90 papers identified, 28 were eligible for inclusion. Eight trials used opt-out, 18 trials used opt-in, and two trials used both to detect new cases of HIV infection. The test was accepted and taken by 75 155 of 172 237 patients (44%) in the opt-out strategy, and 73 581 of 382 992 patients (19%) in the opt-in strategy. The prevalence of HIV infection detected by the opt-out strategy was 0.40% (373 cases), that detected by the opt-in nontargeted strategy was 0.52% (419 cases), and that detected by the opt-in targeted strategy was 1.06% (52 cases). In this meta-analysis, the testing uptake of the opt-out strategy was not different from that of the opt-in strategy to detect new cases of HIV infection in EDs. © 2016 British HIV Association.

Primary aldosteronism and thyroid disorders in atrial fibrillation: A Swedish nationwide case-control study.

PubMed

Mourtzinis, Georgios; Adamsson Eryd, Samuel; Rosengren, Annika; Björck, Lena; Adiels, Martin; Johannsson, Gudmundur; Manhem, Karin

2018-05-01

Background Atrial fibrillation is associated with hyperthyroidism. Patients with primary aldosteronism have an increased prevalence of atrial fibrillation. However, the prevalence of primary aldosteronism in the atrial fibrillation population is unknown. Aim This nationwide case-control study aimed to compare the prevalence of primary aldosteronism and thyroid disorders in patients with atrial fibrillation with that of age- and sex-matched controls. Methods We identified all atrial fibrillation cases in Sweden between 1987 and 2013 ( n = 713,569) by using the Swedish National Patient Register. A control cohort without atrial fibrillation was randomly selected from the Swedish Total Population Register with a case to control ratio of 1:2. This control cohort was matched for age, sex and place of birth ( n = 1,393,953). Results The prevalence of primary aldosteronism in December 2013 was 0.056% in the atrial fibrillation cohort and 0.024% in controls. At the same time, the prevalence of hypothyroidism was 5.9% in the atrial fibrillation cohort and 3.7% in controls. The prevalence of hyperthyroidism was 2.3% in the atrial fibrillation cohort and 0.8% in controls. Conclusion This study shows, for the first time, a doubled prevalence of primary aldosteronism in a large cohort of patients with atrial fibrillation compared with the general population. There is also an increased prevalence of hypo- and hyper-thyroidism in patients with atrial fibrillation compared with the general population.

Assessing variance components in multilevel linear models using approximate Bayes factors: A case study of ethnic disparities in birthweight

PubMed Central

Saville, Benjamin R.; Herring, Amy H.; Kaufman, Jay S.

2013-01-01

Racial/ethnic disparities in birthweight are a large source of differential morbidity and mortality worldwide and have remained largely unexplained in epidemiologic models. We assess the impact of maternal ancestry and census tract residence on infant birth weights in New York City and the modifying effects of race and nativity by incorporating random effects in a multilevel linear model. Evaluating the significance of these predictors involves the test of whether the variances of the random effects are equal to zero. This is problematic because the null hypothesis lies on the boundary of the parameter space. We generalize an approach for assessing random effects in the two-level linear model to a broader class of multilevel linear models by scaling the random effects to the residual variance and introducing parameters that control the relative contribution of the random effects. After integrating over the random effects and variance components, the resulting integrals needed to calculate the Bayes factor can be efficiently approximated with Laplace’s method. PMID:24082430

AIMS baby movement scale application in high-risk infants early intervention analysis.

PubMed

Wang, Y; Shi, J-P; Li, Y-H; Yang, W-H; Tian, Y-J; Gao, J; Li, S-J

2016-05-01

We investigated the application of Alberta Infant Motor Scale (AIMS) in screening motor development delay in the follow-up of high-risk infants who were discharged from NICU, to explain the state of infants' motor development and propose early individualized intervention. The study design was a randomized, single-blind trial by selecting patients between April 2015 and November 2015 in our hospital, children nerve recovery branch clinics and 77 cases of high-risk infants. We randomly divided the patients into observation group (39 cases) and control group (38 cases). To evaluate the application with AIMS, observation group was based on evaluation results for the first time to give rehabilitation training plan making, early intervention, control group according to the growth and development milestone in order to guide parents to take family training interval of 3 months. While comparing the two groups of high-risk infants before the intervention, the months of age, gender, risk factors, it was found that the AIMS scores, each position AIMS scores did not show a significant difference in percentile (p>0.05). There was also no significant difference between two groups in the seat and stand AIMS scores before and after intervention (p>0.05). However, the comparison of two groups of high-risk infants after intervention in comparison showed that the observation group supine AIMS scores and AIMS scores were significantly higher than the control group (p<0.05). Prone position AIMS scores observation group was also significantly higher than that of the control group (p<0.01). The corresponding percentile for two groups after the intervention of AIMS scores was less than 10% of cases, which was significantly lower in the observation group (p<0.01). AIMS can predict the development delay in high-risk infants, for improving the early hypernymic diagnosis and intervention.

MTHFR 677C>T Polymorphism and the Risk of Breast Cancer: Evidence from an Original Study and Pooled Data for 28031 Cases and 31880 Controls

PubMed Central

Sekhar, Deepa; Francis, Amirtharaj; Gupta, Nishi; Konwar, Rituraj; Kumar, Sandeep; Kumar, Surender; Thangaraj, Kumarasamy; Rajender, Singh

2015-01-01

Background Methylenetetrahydrofolate reductase (MTHFR) acts at an important metabolic point in the regulation of cellular methylation reaction. It assists in the conversion of 5, 10-methylenetetrahydrofolate to 5-methyltetrahydrofolate. The latter aids in remethylation of homocysteine to de novo methionine that is required for DNA synthesis. The objective of this study was to examine the effect of MTHFR 677 C>T polymorphism on the risk of breast cancer in the Indian sub-continent. Methods and Results We genotyped 677 C>T locus in 1096 individuals that were classified into cases (N=588) and controls (N=508). Genotype data were analyzed using chi-square test. No significant difference was observed in the distribution of genotypes between cases and controls in north Indian (P = 0.932), south Indian (P = 0.865), and pooled data (P = 0.680). To develop a consensus regarding the impact of 677C>T polymorphism on breast cancer risk, we also conducted a meta-analysis on 28031 cases and 31880 controls that were pooled from sixty one studies. The overall summary estimate upon meta-analysis suggested no significant correlation between the 677C>T substitution and breast cancer in the dominant model (Fixed effect model: OR = 0.97, P=0.072, Random effects model: OR = 0.96, P = 0.084) or the recessive model (Fixed effect model: OR = 1.05, P = 0.089; Random effects model: OR= 1.08, P= 0.067). Conclusion 677 C>T substitution does not affect breast cancer risk in the Indo-European and Dravidian populations of India. Analysis on pooled data further ruled out association between the 677 C>T polymorphism and breast cancer. Therefore, 677 C>T substitution does not appear to influence the risk of breast cancer. PMID:25803740

Training mentors of clinical and translational research scholars: a randomized controlled trial.

PubMed

Pfund, Christine; House, Stephanie C; Asquith, Pamela; Fleming, Michael F; Buhr, Kevin A; Burnham, Ellen L; Eichenberger Gilmore, Julie M; Huskins, W Charles; McGee, Richard; Schurr, Kathryn; Shapiro, Eugene D; Spencer, Kimberly C; Sorkness, Christine A

2014-05-01

To determine whether a structured mentoring curriculum improves research mentoring skills. The authors conducted a randomized controlled trial (RCT) at 16 academic health centers (June 2010 to July 2011). Faculty mentors of trainees who were conducting clinical/translational research ≥50% of the time were eligible. The intervention was an eight-hour, case-based curriculum focused on six mentoring competencies. The primary outcome was the change in mentors' self-reported pretest to posttest composite scores on the Mentoring Competency Assessment (MCA). Secondary outcomes included changes in the following: mentors' awareness as measured by their self-reported retrospective change in MCA scores, mentees' ratings of their mentors' competency as measured by MCA scores, and mentoring behaviors as reported by mentors and their mentees. A total of 283 mentor-mentee pairs were enrolled: 144 mentors were randomized to the intervention; 139 to the control condition. Self-reported pre-/posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls (P < .001). Retrospective changes in MCA composite scores between the two groups were even greater, and extended to all six subscale scores (P < .001). More intervention-group mentors reported changes in their mentoring practices than control mentors (P < .001). Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre-/posttest scores (P = .003) and more changes in their mentors' behavior (P = .002) than those paired with control mentors. This RCT demonstrates that a competency-based research mentor training program can improve mentors' skills.

Acute pulmonary emphysema in death by hanging: a morphometric digital study.

PubMed

Castiglioni, Claudia; Baumann, Pia; Fracasso, Tony

2016-09-01

Acute pulmonary emphysema (APE) has been described in cases of mechanical asphyxia such as ligature or manual strangulation but not in cases of hanging. In this study, we wanted to verify by morphometric digital analysis of lung tissue whether APE occurs in death by hanging.We investigated 16 cases of hanging (eight complete, eight incomplete), 10 cases of freshwater drowning (positive control group), and 10 cases of acute external bleeding (negative control group). Tissue sections were obtained from each pulmonary lobe. For each slide, five fields were randomly selected. The area of every alveolar space was measured by image analysis software. The mean alveolar area (MAA) was calculated for each group.In incomplete hanging, MAA was significantly higher than that observed in complete hanging and similar to the one observed in freshwater drowning.APE in cases of incomplete hanging can be considered as a sign of vitality. The high number of conditions that can cause alveolar distension (that were excluded in this study) limits the applicability of this vital sign in the routine forensic practice.

Effects of case management in community aged care on client and carer outcomes: a systematic review of randomized trials and comparative observational studies

PubMed Central

2012-01-01

Background Case management has been applied in community aged care to meet frail older people’s holistic needs and promote cost-effectiveness. This systematic review aims to evaluate the effects of case management in community aged care on client and carer outcomes. Methods We searched Web of Science, Scopus, Medline, CINAHL (EBSCO) and PsycINFO (CSA) from inception to 2011 July. Inclusion criteria were: no restriction on date, English language, community-dwelling older people and/or carers, case management in community aged care, published in refereed journals, randomized control trials (RCTs) or comparative observational studies, examining client or carer outcomes. Quality of studies was assessed by using such indicators as quality control, randomization, comparability, follow-up rate, dropout, blinding assessors, and intention-to-treat analysis. Two reviewers independently screened potentially relevant studies, extracted information and assessed study quality. A narrative summary of findings were presented. Results Ten RCTs and five comparative observational studies were identified. One RCT was rated high quality. Client outcomes included mortality (7 studies), physical or cognitive functioning (6 studies), medical conditions (2 studies), behavioral problems (2 studies) , unmet service needs (3 studies), psychological health or well-being (7 studies) , and satisfaction with care (4 studies), while carer outcomes included stress or burden (6 studies), satisfaction with care (2 studies), psychological health or well-being (5 studies), and social consequences (such as social support and relationships with clients) (2 studies). Five of the seven studies reported that case management in community aged care interventions significantly improved psychological health or well-being in the intervention group, while all the three studies consistently reported fewer unmet service needs among the intervention participants. In contrast, available studies reported mixed results regarding client physical or cognitive functioning and carer stress or burden. There was also limited evidence indicating significant effects of the interventions on the other client and carer outcomes as described above. Conclusions Available evidence showed that case management in community aged care can improve client psychological health or well-being and unmet service needs. Future studies should investigate what specific components of case management are crucial in improving clients and their carers’ outcomes. PMID:23151143

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.

Nosocomial outbreak of staphylococcal scalded skin syndrome in neonates: epidemiological investigation and control.

PubMed

El Helali, N; Carbonne, A; Naas, T; Kerneis, S; Fresco, O; Giovangrandi, Y; Fortineau, N; Nordmann, P; Astagneau, P

2005-10-01

Over a three-month period, 13 neonates developed staphylococcal scalded skin syndrome (SSSS) in a maternity unit, between four and 18 days after their birth. An epidemiological and descriptive study followed by a case-control study was performed. A case was defined as a neonate with blistering or peeling skin, and exfoliative toxin A Staphylococcus aureus positive cultures. Controls were selected at random from the asymptomatic, non-colonized neonates born on the same day as the cases. All staff members and all neonates born during the outbreak period were screened for carriage by nasal swabs and umbilical swabs, respectively. S. aureus isolates were polymerase chain reaction (PCR) screened for etA gene and genotyped by pulsed-field gel electrophoresis (PFGE). Two clusters of eight and five cases were identified. Receiving more than one early umbilical care procedure by the same ancillary nurse was the only risk factor identified in the case-control study (odds ratio=15, 95% confidence intervals 2-328). The ancillary nurse suffered from chronic dermatitis on her hands that favoured S. aureus carriage. Exfoliative-toxin-A-producing strains, as evidenced by PCR and indistinguishable by PFGE, were isolated from all but one of the SSSS cases, from four asymptomatic neonates, from two staff members and from the ancillary nurse's hands. Removal of the ancillary nurse from duty, infection control measures (isolation precautions, chlorhexidine handwashing and barrier protections), and treatment of the carriers (nasal mupirocin and chlorhexidine showers) led to control of the epidemic. In conclusion, this study emphasizes the need for tight surveillance of chronic dermatitis in healthcare workers.

Active Ankle Movements Prevent Formation of Lower-Extremity Deep Venous Thrombosis After Orthopedic Surgery

PubMed Central

Li, Ye; Guan, Xiang-Hong; Wang, Rui; Li, Bin; Ning, Bo; Su, Wei; Sun, Tao; Li, Hong-Yan

2016-01-01

Background The aim of this study was to assess the preventive value of active ankle movements in the formation of lower-extremity deep venous thrombosis (DVT), attempting to develop a new method for rehabilitation nursing after orthopedic surgery. Material/Methods We randomly assigned 193 patients undergoing orthopedic surgery in the lower limbs into a case group (n=96) and a control group (n=97). The control group received routine nursing while the case group performed active ankle movements in addition to receiving routine nursing. Maximum venous outflow (MVO), maximum venous capacity (MVC), and blood rheology were measured and the incidence of DVT was recorded. Results On the 11th and 14th days of the experiment, the case group had significantly higher MVO and MVC than the control group (all P<0.05). The whole-blood viscosity at high shear rate and the plasma viscosity were significantly lower in the case group than in the control group on the 14th day (both P<0.05). During the experiment, a significantly higher overall DVT incidence was recorded in the control group (8 with asymptomatic DVT) compared with the case group (1 with asymptomatic DVT) (P=0.034). During follow-up, the case group presented a significantly lower DVT incidence (1 with symptomatic DVT and 4 with asymptomatic DVT) than in the control group (5 with symptomatic DVT and 10 with asymptomatic DVT) (P=0.031). Conclusions Through increasing MVO and MVC and reducing blood rheology, active ankle movements may prevent the formation of lower-extremity DVT after orthopedic surgery. PMID:27600467

Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants.

PubMed

Cristofalo, Elizabeth A; Schanler, Richard J; Blanco, Cynthia L; Sullivan, Sandra; Trawoeger, Rudolf; Kiechl-Kohlendorfer, Ursula; Dudell, Golde; Rechtman, David J; Lee, Martin L; Lucas, Alan; Abrams, Steven

2013-12-01

To compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human milk. Multicenter randomized controlled trial. The authors studied extremely preterm infants whose mothers did not provide their milk. Infants were fed either BOV or an exclusive human milk diet of pasteurized donor human milk and HUM. The major outcome was duration of parenteral nutrition. Secondary outcomes were growth, respiratory support, and necrotizing enterocolitis (NEC). Birth weight (983 vs 996 g) and gestational age (27.5 vs 27.7 wk), in BOV and HUM, respectively, were similar. There was a significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM, respectively (P = .04). The incidence of NEC in BOV was 21% (5 cases) vs 3% in HUM (1 case), P = .08; surgical NEC was significantly higher in BOV (4 cases) than HUM (0 cases), P = .04. In extremely preterm infants given exclusive diets of preterm formula vs human milk, there was a significantly greater duration of parenteral nutrition and higher rate of surgical NEC in infants receiving preterm formula. This trial supports the use of an exclusive human milk diet to nourish extremely preterm infants in the neonatal intensive care unit. Copyright © 2013 Mosby, Inc. All rights reserved.

Effects of a Web-based tailored intervention to reduce alcohol consumption in adults: randomized controlled trial.

PubMed

Schulz, Daniela N; Candel, Math Jjm; Kremers, Stef Pj; Reinwand, Dominique A; Jander, Astrid; de Vries, Hein

2013-09-17

Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents' attention in online interventions. To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult drinkers and to compare 2 computer-tailoring feedback strategies (alternating vs summative) on behavioral change, dropout, and appreciation of the program. A single-blind randomized controlled trial was conducted with an experimental group and a control group (N=448) in Germany in 2010-2011. Follow-up took place after 6 months. Drinking behavior, health status, motivational determinants, and demographics were assessed among participants recruited via an online access panel. The experimental group was divided into 2 subgroups. In the alternating condition (n=132), the tailored feedback was split into a series of messages discussing individual topics offered while the respondent was filling out the program. Participants in the summative condition (n=181) received all advice at once after having answered all questions. The actual texts were identical for both conditions. The control group (n=135) only filled in 3 questionnaires. To identify intervention effects, logistic and linear regression analyses were conducted among complete cases (n=197) and after using multiple imputation. Among the complete cases (response rate: 197/448, 44.0%) who did not comply with the German national guideline for low-risk drinking at baseline, 21.1% of respondents in the experimental group complied after 6 months compared with 5.8% in the control group (effect size=0.42; OR 2.65, 95% CI 1.14-6.16, P=.02). The experimental group decreased by 3.9 drinks per week compared to 0.4 drinks per week in the control group, but this did not reach statistical significance (effect size=0.26; beta=-0.12, 95% CI -7.96 to 0.03, P=.05). Intention-to-treat analyses also indicated no statistically significant effect. Separate analyses of the 2 experimental subgroups showed no differences in intervention effects. The dropout rate during the first visit to the intervention website was significantly lower in the alternating condition than in the summative condition (OR 0.23, 95% CI 0.08-0.60, P=.003). Program appreciation was comparable for the 2 experimental groups. Complete case analyses revealed that Web-based tailored feedback can be an effective way to reduce alcohol intake among adults. However, this effect was not confirmed when applying multiple imputations. There was no indication that one of the tailoring strategies was more effective in lowering alcohol intake. Nevertheless, the lower attrition rates we found during the first visit suggest that the version of the intervention with alternating questions and advice may be preferred. International Standard Randomized Controlled Trial Number (ISRCTN): 91623132; http://www.controlled-trials.com/ISRCTN91623132 (Archived by WebCite at http://www.webcitation.org/6J4QdhXeG).

Effects of a Web-Based Tailored Intervention to Reduce Alcohol Consumption in Adults: Randomized Controlled Trial

PubMed Central

Candel, Math JJM; Kremers, Stef PJ; Reinwand, Dominique A; Jander, Astrid; de Vries, Hein

2013-01-01

Background Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents’ attention in online interventions. Objective To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult drinkers and to compare 2 computer-tailoring feedback strategies (alternating vs summative) on behavioral change, dropout, and appreciation of the program. Methods A single-blind randomized controlled trial was conducted with an experimental group and a control group (N=448) in Germany in 2010-2011. Follow-up took place after 6 months. Drinking behavior, health status, motivational determinants, and demographics were assessed among participants recruited via an online access panel. The experimental group was divided into 2 subgroups. In the alternating condition (n=132), the tailored feedback was split into a series of messages discussing individual topics offered while the respondent was filling out the program. Participants in the summative condition (n=181) received all advice at once after having answered all questions. The actual texts were identical for both conditions. The control group (n=135) only filled in 3 questionnaires. To identify intervention effects, logistic and linear regression analyses were conducted among complete cases (n=197) and after using multiple imputation. Results Among the complete cases (response rate: 197/448, 44.0%) who did not comply with the German national guideline for low-risk drinking at baseline, 21.1% of respondents in the experimental group complied after 6 months compared with 5.8% in the control group (effect size=0.42; OR 2.65, 95% CI 1.14-6.16, P=.02). The experimental group decreased by 3.9 drinks per week compared to 0.4 drinks per week in the control group, but this did not reach statistical significance (effect size=0.26; beta=−0.12, 95% CI −7.96 to 0.03, P=.05). Intention-to-treat analyses also indicated no statistically significant effect. Separate analyses of the 2 experimental subgroups showed no differences in intervention effects. The dropout rate during the first visit to the intervention website was significantly lower in the alternating condition than in the summative condition (OR 0.23, 95% CI 0.08-0.60, P=.003). Program appreciation was comparable for the 2 experimental groups. Conclusions Complete case analyses revealed that Web-based tailored feedback can be an effective way to reduce alcohol intake among adults. However, this effect was not confirmed when applying multiple imputations. There was no indication that one of the tailoring strategies was more effective in lowering alcohol intake. Nevertheless, the lower attrition rates we found during the first visit suggest that the version of the intervention with alternating questions and advice may be preferred. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 91623132; http://www.controlled-trials.com/ISRCTN91623132 (Archived by WebCite at http://www.webcitation.org/6J4QdhXeG). PMID:24045005

Multi-Modal Preemptive Analgesia With Pregabalin, Acetaminophen, Naproxen, and Dextromethorphan in Radical Neck Dissection Surgery: A Randomized Clinical Trial

PubMed Central

Amiri, Hamid Reza; Mirzaei, Mojtaba; Beig Mohammadi, Mohammad Taghi; Tavakoli, Farhad

2016-01-01

Background Preemptive analgesia may be considered as a method not only to alleviate postoperative pain but also to decrease analgesic consumption. Different regimens are suggested, but there is currently no standard. Objectives The aim was to measure the efficacy of preemptive analgesia with pregabalin, acetaminophen, naproxen, and dextromethorphan in radical neck dissection surgery for reducing the intensity of pain and morphine consumption. Patients and Methods This study was conducted as a randomized double-blind clinical trial. Eighty adult patients (18 to 60 years of age) under the American society of anesthesiologists (ASA) physical status I and II undergoing elective radical neck dissection were enrolled. Patients were randomized into two groups of 40 with a simple randomization method. The case group received a combination of 15 mg/kg acetaminophen, 2.5 mg/kg pregabalin, 7 mg/kg naproxen, and 0.3 mg/kg dextromethorphan administered orally one hour prior to surgery. Postoperative pain was assessed with the universal pain assessment tool (UPAT) at 0, 2, 4, 6, 12, and 24 hours after surgery. Subjects received morphine based on postoperative pain control protocol. Total administered morphine doses were noted. Results Postoperative pain rates at 0, 2, 4, 6, 12, and 24 hours after surgery were significantly lower for the case group than the control group (P values = 0.014, 0.003, 0.00, 0.00, and 0.00, respectively). Total morphine doses for the preemptive analgesia group were 45% lower than those of the other group. Side effects were similar for both groups. Conclusions A single preoperative oral dose of pregabalin, acetaminophen, dextromethorphan, and naproxen one hour before surgery is an effective method for reducing postoperative pain and morphine consumption in patients undergoing radical neck dissection. PMID:27843771

Experimental demonstration of spatially coherent beam combining using optical parametric amplification.

PubMed

Kurita, Takashi; Sueda, Keiichi; Tsubakimoto, Koji; Miyanaga, Noriaki

2010-07-05

We experimentally demonstrated coherent beam combining using optical parametric amplification with a nonlinear crystal pumped by random-phased multiple-beam array of the second harmonic of a Nd:YAG laser at 10-Hz repetition rate. In the proof-of-principle experiment, the phase jump between two pump beams was precisely controlled by a motorized actuator. For the demonstration of multiple-beam combining a random phase plate was used to create random-phased beamlets as a pump pulse. Far-field patterns of the pump, the signal, and the idler indicated that the spatially coherent signal beams were obtained on both cases. This approach allows scaling of the intensity of optical parametric chirped pulse amplification up to the exa-watt level while maintaining diffraction-limited beam quality.

Case-control Studies on the Effectiveness of Breast Cancer Screening: Insights from the UK Age Trial.

PubMed

van der Waal, Daniëlle; Broeders, Mireille J M; Verbeek, André L M; Duffy, Stephen W; Moss, Sue M

2015-07-01

Ongoing breast cancer screening programs can only be evaluated using observational study designs. Most studies have observed a reduction in breast cancer mortality, but design differences appear to have resulted in different estimates. Direct comparison of case-control and trial analyses gives more insight into this variation. Here, we performed case-control analyses within the randomized UK Age Trial. The Age Trial assessed the effect of screening on breast cancer mortality in women ages 40-49 years. In our approach, case subjects were defined as breast cancer deaths between trial entry (1991-1997) and 2004. Women were ages 39-41 years at entry. For every case subject, five control subjects were selected. All case subjects were included in analyses of screening invitation (356 case subjects, 1,780 controls), whereas analyses of attendance were restricted to women invited to screening (105 case subjects, 525 age-matched controls). Odds ratios (OR) were estimated with conditional logistic regression. We used and compared two methods to correct for self-selection bias. Screening invitation resulted in a breast cancer mortality reduction of 17% (95% confidence interval [CI]: -36%, +6%), similar to trial results. Different exposure definitions and self-selection adjustments influenced the observed breast cancer mortality reduction. Depending on the method, "ever screened" appeared to be associated with a small reduction (OR: 0.86, 95% CI: 0.40, 1.89) or no reduction (OR: 1.02, 95% CI: 0.48, 2.14) using the two methods of correction. Recent attendance resulted in an adjusted mortality reduction of 36% (95% CI: -69%, +31%) or 45% (95% CI: -71%, +5%). Observational studies, and particularly case-control studies, are an important monitoring tool for breast cancer screening programs. The focus should be on diminishing bias in observational studies and gaining a better understanding of the influence of study design on estimates of mortality reduction.

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

PubMed Central

Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-01-01

Background Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. Objective The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. Methods A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. Results A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI –0.12 to 1.05) and 9 months (mean change 0.39, 95% CI –0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically meaningful improvement compared with the usual care group. Conclusions This study supported the use of MAP to enhance asthma quality of life but not asthma control as measured by an administrative database. Implementation of MAP beyond 6 months with tailored protocols for monitoring symptoms and health behaviors as individuals’ knowledge and self-management skills improve may result in long-term gains in asthma control. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 34326236; http://www.isrctn.com/ISRCTN34326236 (Archived by Webcite at http://www.webcitation.org/6mGxoI1R7). PMID:27908846

Effect of dexamethasone on intelligence and hearing in preterm infants: a meta-analysis.

PubMed

Zhang, Ruolin; Bo, Tao; Shen, Li; Luo, Senlin; Li, Jian

2014-03-15

A meta-analysis of published randomized controlled trials investigating the long-term effect of dexamethasone on the nervous system of preterm infants. Online literature retrieval was conducted using The Cochrane Library (from January 1993 to June 2013), EMBASE (from January 1980 to June 2013), MEDLINE (from January 1963 to June 2013), OVID (from January 1993 to June 2013), Springer (from January 1994 to June 2013) and Chinese Academic Journal Full-text Database (from January 1994 to June 2013). Key words were preterm infants and dexamethasone in English and Chinese. Selected studies were randomized controlled trials assessing the effect of intravenous dexamethasone in preterm infants. The quality of the included papers was evaluated and those without the development of the nervous system and animal experiments were excluded. Quality assessment was performed through bias risk evaluation in accordance with Cochrane Handbook 5.1.0 software in the Cochrane Collaboration. The homogeneous studies were analyzed and compared using Revman 5.2.6 software, and then effect model was selected and analyzed. Those papers failed to be included in the meta-analysis were subjected to descriptive analysis. Nervous system injury in preterm infants. Ten randomized controlled trials were screened, involving 1,038 subjects. Among them 512 cases received dexamethasone treatment while 526 cases served as placebo control group and blank control group. Meta-analysis results showed that the incidence of cerebral palsy, visual impairment and hearing loss in preterm infants after dexamethasone treatment within 7 days after birth was similar to that in the control group (RR = 1.47, 95%CI: 0.97-2.21; RR = 1.46, 95%CI: 0.97-2.20; RR = 0.80, 95%CI: 0.54-1.18; P > 0.05), but intelligence quotient was significantly decreased compared with the control group (MD = -3.55, 95%CI: -6.59 to -0.51; P = 0.02). Preterm infants treated with dexamethasone 7 days after birth demonstrated an incidence of cerebral palsy and visual impairment, and changes in intelligence quotient similar to those in the control group (RR = 1.26, 95%CI: 0.89-1.79; RR = 1.37, 95%CI: 0.73-2.59; RR = 0.53, 95%CI: 0.32-0.89; RR = 1.66, 95%CI: -4.7 to 8.01; P > 0.05). However, the incidence of hearing loss was significantly increased compared with that in the control group (RR = 0.53, 95%CI: 0.32-0.89; P = 0.02). Dexamethasone may affect the intelligence of preterm infants in the early stages after birth, but may lead to hearing impairment at later stages after birth. More reliable conclusions should be made through large-size, multi-center, well-designed randomized controlled trials.

Effects of soybean oligosaccharides on antioxidant enzyme activities and insulin resistance in pregnant women with gestational diabetes mellitus.

PubMed

Fei, Bei-bei; Ling, Li; Hua, Chen; Ren, Shu-yan

2014-09-01

The effects of soybean oligosaccharides (SBOS) on antioxidant enzyme activities and insulin resistance in pregnant women with gestational diabetes mellitus (GDM) were investigated. Ninety-seven pregnant women with GDM were randomly divided into two groups, the control group (51 cases) and the SBOS group (46 cases). Before the group separation, the blood sugar level in patients was maintained stable by regular diet and insulin treatment. The control group was continued with the insulin treatment, while the SBOS group was treated with the combination of insulin and SBOS. Results showed that SBOS were able to reduce oxidative stress and alleviate insulin resistance in pregnant women with GDM, which indicates that SBOS may play an important role in the control of GDM complications. Copyright © 2014 Elsevier Ltd. All rights reserved.

Trial of an electronic decision support system to facilitate shared decision making in community mental health.

PubMed

Woltmann, Emily M; Wilkniss, Sandra M; Teachout, Alexandra; McHugo, Gregory J; Drake, Robert E

2011-01-01

Involvement of community mental health consumers in mental health decision making has been consistently associated with improvements in health outcomes. Electronic decision support systems (EDSSs) that support both consumer and provider decision making may be a sustainable way to improve dyadic communication in a field with approximately 50% workforce turnover per year. This study examined the feasibility of such a system and investigated proximal outcomes of the system's performance. A cluster randomized design was used to evaluate an EDSS at three urban community mental health sites. Case managers (N=20) were randomly assigned to the EDSS-supported planning group or to the usual care planning group. Consumers (N=80) were assigned to the same group as their case managers. User satisfaction with the care planning process was assessed for consumers and case managers (possible scores range from 1 to 5, with higher summary scores indicating more satisfaction). Recall of the care plan was assessed for consumers. Linear regression with adjustment for grouping by worker was used to assess satisfaction scores. A Wilcoxon rank-sum test was used to examine knowledge of the care plan. Compared with case managers in the control group, those in the intervention group were significantly more satisfied with the care planning process (mean ± SD score=4.0 ± .5 versus 3.3 ± .5; adjusted p=.01). Compared with consumers in the control group, those in the intervention group had significantly greater recall of their care plans three days after the planning session (mean proportion of plan goals recalled=75% ± 28% versus 57% ± 32%; p=.02). There were no differences between the clients in the intervention and control groups regarding satisfaction. This study demonstrated that clients can build their own care plans and negotiate and revise them with their case managers using an EDSS.

Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study.

PubMed

Bellini, Cristina; Petignat, Christiane; Masserey, Eric; Büla, Christophe; Burnand, Bernard; Rousson, Valentin; Blanc, Dominique S; Zanetti, Giorgio

2015-04-01

The risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs. Cluster randomized controlled trial. NHs of the state of Vaud, Switzerland. Of 157 total NHs in Vaud, 104 (67%) participated in the study. Standard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers. NHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%-100%) in control NHs and 87% (20%-100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%-43%) and intervention NHs (range, 0%-38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66). Universal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.

An assessment of the effectiveness of tobacco control measures on behavior changes related to tobacco use among adolescents and young adults in a district in Sri Lanka.

PubMed

De Silva, W D; Sinha, D N; Kahandawaliyanag, A

2012-01-01

Sri Lanka became a signatory to the WHO Frame Work Convention on Tobacco Control in September 2003, and this was ratified in November 2003. With a view to reduce the use of tobacco in Sri Lanka, the National Authority on Tobacco and Alcohol Act (NATA) No. 27 of 2006 was implemented. To assess the behavior changes related to tobacco use among adolescents and young adults following exposure to tobacco control measures were implemented by NATA. A case-control study was conducted on 42 adolescent (aged 13-19 years) and 156 young adult (aged 20-39 years) men living in Anuradhapura Divisional Secretary area in Sri Lanka. Cases (current quitters) and controls (current smokers) were compared to ascertain the outcome following the exposure to tobacco control measures. A self-administered questionnaire and focus group discussions were used to ascertain the exposure status in cases and controls. Confounding was controlled by stratification and randomization. Univariate analysis was performed by Backward Stepwise (Likelihood Ratio) method. Among 198 respondents, 66 (27.3% adolescents and 72.7% young adults) were quitters, while 132 smokers (18.2% adolescents and 81.8% young adults) were current smokers. Exposure to the anti-smoking media messages revealed that TV was the strongest media that motivated smokers to quit smoking. Majority (66%) of cases and control were not exposed to tobacco promotion advertisements, while 47% of the cases and 50% of the control had never seen tobacco advertisements during community events. All cases (66) as well as 89% (118) of the control had not noticed competitions or prizes sponsored by tobacco industry during last year ( P = 0.13). Tobacco control measures implemented by NATA had a favorable influence on behavior change related to smoking among quitters and current smokers.

Therapeutic Exercise Training to Reduce Chronic Headache in Working Women: Design of a Randomized Controlled Trial.

PubMed

Rinne, Marjo; Garam, Sanna; Häkkinen, Arja; Ylinen, Jari; Kukkonen-Harjula, Katriina; Nikander, Riku

2016-05-01

Cervicogenic headache and migraine are common causes of visits to physicians and physical therapists. Few randomized trials utilizing active physical therapy and progressive therapeutic exercise have been previously published. The existing evidence on active treatment methods supports a moderate effect on cervicogenic headache. The aim of this study is to investigate whether a progressive, group-based therapeutic exercise program decreases the intensity and frequency of chronic headache among women compared with a control group receiving a sham dose of transcutaneous electrical nerve stimulation (TENS) and stretching exercises. A randomized controlled trial with 6-month intervention and follow-up was developed. The participants were randomly assigned to either a treatment group or a control group. The study is being conducted at 2 study centers. The participants are women aged 18 to 60 years with chronic cervicogenic headache or migraine. The treatment group's exercise program consisted of 6 progressive therapeutic exercise modules, including proprioceptive low-load progressive craniocervical and cervical exercises and high-load exercises for the neck muscles. The participants in the control group received 6 individually performed sham TENS treatment sessions. The primary outcome is the intensity of headache. The secondary outcomes are changes in frequency and duration of headache, neck muscle strength, neck and shoulder flexibility, impact of headache on daily life, neck disability, fear-avoidance beliefs, work ability, and quality of life. Between-group differences will be analyzed separately at 6, 12, and 24 months with generalized linear mixed models. In the case of count data (eg, frequency of headache), Poisson or negative binomial regression will be used. The therapists are not blinded. The effects of specific therapeutic exercises on frequency, intensity, and duration of chronic headache and migraine will be reported. © 2016 American Physical Therapy Association.

Impact of vitamin D supplementation on the outcome of tuberculosis treatment: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Xia, Jingyan; Shi, Liyun; Zhao, Lifang; Xu, Feng

2014-01-01

Vitamin D supplementation is believed to be beneficial in the treatment of patients with tuberculosis (TB), however, results from clinical trials have been inconclusive. We performed a systematic literature search across MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Springer, EBSCO, ProQuest, HighWire Press, and Web of Science, published as of December 2013. We individually inspected citations and extracted data independently. We estimated pooled risk ratios (RR) and 95% confidence intervals (CI) using random-effect models. We also assessed risk of bias using the Jadad scale and the quality of the evidence using GRADE. We included all randomized controlled trials comparing vitamin D with or without standard TB therapy or placebo. A total of five studies were analyzed in our meta analysis covering 841 newly-diagnosed TB cases. Patients receiving vitamin D supplementation had a 39% reduced risk of sputum smear or culture positive after six weeks of anti-TB treatment than those in the control group, although this is not statistically significant (pooled RR 0.61, 95% CI 0.24 to 1.56, P = 0.30). Apart from an increased serum vitamin D level in the supplement group after eight weeks of treatment there was no evidence of any additional adverse effects related to vitamin D. The meta analysis results indicate that vitamin D supplementation does not seem to have any beneficial effect in the treatment of TB. Future rigorous randomized controlled trials are needed to explore whether the supplementation of vitamin D could shorten treatment duration and to confirm whether the polymorphisms of vitamin D receptor have any potentially beneficial effect.

Case-control geographic clustering for residential histories accounting for risk factors and covariates.

PubMed

Jacquez, Geoffrey M; Meliker, Jaymie R; Avruskin, Gillian A; Goovaerts, Pierre; Kaufmann, Andy; Wilson, Mark L; Nriagu, Jerome

2006-08-03

Methods for analyzing space-time variation in risk in case-control studies typically ignore residential mobility. We develop an approach for analyzing case-control data for mobile individuals and apply it to study bladder cancer in 11 counties in southeastern Michigan. At this time data collection is incomplete and no inferences should be drawn - we analyze these data to demonstrate the novel methods. Global, local and focused clustering of residential histories for 219 cases and 437 controls is quantified using time-dependent nearest neighbor relationships. Business address histories for 268 industries that release known or suspected bladder cancer carcinogens are analyzed. A logistic model accounting for smoking, gender, age, race and education specifies the probability of being a case, and is incorporated into the cluster randomization procedures. Sensitivity of clustering to definition of the proximity metric is assessed for 1 to 75 k nearest neighbors. Global clustering is partly explained by the covariates but remains statistically significant at 12 of the 14 levels of k considered. After accounting for the covariates 26 Local clusters are found in Lapeer, Ingham, Oakland and Jackson counties, with the clusters in Ingham and Oakland counties appearing in 1950 and persisting to the present. Statistically significant focused clusters are found about the business address histories of 22 industries located in Oakland (19 clusters), Ingham (2) and Jackson (1) counties. Clusters in central and southeastern Oakland County appear in the 1930's and persist to the present day. These methods provide a systematic approach for evaluating a series of increasingly realistic alternative hypotheses regarding the sources of excess risk. So long as selection of cases and controls is population-based and not geographically biased, these tools can provide insights into geographic risk factors that were not specifically assessed in the case-control study design.

Direct medical costs of constipation from childhood to early adulthood: a population-based birth cohort study.

PubMed

Choung, Rok Seon; Shah, Nilay D; Chitkara, Denesh; Branda, Megan E; Van Tilburg, Miranda A; Whitehead, William E; Katusic, Slavica K; Locke, G Richard; Talley, Nicholas J

2011-01-01

Although direct medical costs for constipation-related medical visits are thought to be high, to date there have been no studies examining whether longitudinal resource use is persistently elevated in children with constipation. Our aim was to estimate the incremental direct medical costs and types of health care use associated with constipation from childhood to early adulthood. A nested case-control study was conducted to evaluate the incremental costs associated with constipation. The original sample consisted of 5718 children in a population-based birth cohort who were born during 1976 to 1982 in Rochester, MN. The cases included individuals who presented to medical facilities with constipation. The controls were matched and randomly selected among all noncases in the sample. Direct medical costs for cases and controls were collected from the time subjects were between 5 and 18 years of age or until the subject emigrated from the community. We identified 250 cases with a diagnosis of constipation in the birth cohort. Although the mean inpatient costs for cases were $9994 (95% Confidence interval [CI] 2538-37,201) compared with $2391 (95% CI 923-7452) for controls (P = 0.22) during the time period, the mean outpatient costs for cases were $13,927 (95% CI 11,325-16,525) compared with $3448 (95% CI 3771-4621) for controls (P < 0.001) during the same time period. The mean annual number of emergency department visits for cases was 0.66 (95% CI 0.62-0.70) compared with 0.34 (95% CI 0.32-0.35) for controls (P < 0.0001). Individuals with constipation have higher medical care use. Outpatient costs and emergency department use were significantly greater for individuals with constipation from childhood to early adulthood.

Design and application of nickel-titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial.

PubMed

Chen, Xiao; Liu, Peng; Zhu, Xiaofei; Cao, Liehu; Zhang, Chuncai; Su, Jiacan

2013-06-01

We carried out this study to test the efficacy of the olecranon memory connector (OMC) in olecranon fractures. We designed a prospective randomised controlled trial involving 40 cases of olecranon fractures. From May 2004 to December 2009, 40 patients with olecranon fractures were randomly assigned into two groups. Twenty patients were treated with OMC, while another 20 patients were fixed with locking plates in our hospital. The DASH score, MEP score, range of motion and radiographs were used to evaluate the postoperative elbow function and complications. For MEP score, OMC was better than the locking plate; for DASH score, complication rate, and range of elbow motion, the two methods presented no significant difference. The study showed that OMC could be an effective alternative to treat olecranon fractures.

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

PubMed

Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

Early Colorectal Cancer Detected by Machine Learning Model Using Gender, Age, and Complete Blood Count Data.

PubMed

Hornbrook, Mark C; Goshen, Ran; Choman, Eran; O'Keeffe-Rosetti, Maureen; Kinar, Yaron; Liles, Elizabeth G; Rust, Kristal C

2017-10-01

Machine learning tools identify patients with blood counts indicating greater likelihood of colorectal cancer and warranting colonoscopy referral. To validate a machine learning colorectal cancer detection model on a US community-based insured adult population. Eligible colorectal cancer cases (439 females, 461 males) with complete blood counts before diagnosis were identified from Kaiser Permanente Northwest Region's Tumor Registry. Control patients (n = 9108) were randomly selected from KPNW's population who had no cancers, received at ≥1 blood count, had continuous enrollment from 180 days prior to the blood count through 24 months after the count, and were aged 40-89. For each control, one blood count was randomly selected as the pseudo-colorectal cancer diagnosis date for matching to cases, and assigned a "calendar year" based on the count date. For each calendar year, 18 controls were randomly selected to match the general enrollment's 10-year age groups and lengths of continuous enrollment. Prediction performance was evaluated by area under the curve, specificity, and odds ratios. Area under the receiver operating characteristics curve for detecting colorectal cancer was 0.80 ± 0.01. At 99% specificity, the odds ratio for association of a high-risk detection score with colorectal cancer was 34.7 (95% CI 28.9-40.4). The detection model had the highest accuracy in identifying right-sided colorectal cancers. ColonFlag ® identifies individuals with tenfold higher risk of undiagnosed colorectal cancer at curable stages (0/I/II), flags colorectal tumors 180-360 days prior to usual clinical diagnosis, and is more accurate at identifying right-sided (compared to left-sided) colorectal cancers.

Effect of Maintenance Therapy with Isoxsuprine in the Prevention of Preterm Labor: Randomized controlled trial

PubMed Central

Alavi, Azin; Rajaee, Minoo; Amirian, Malihe; Mahboobi, Hamidreza; Jahanshahi, Keramat Allah; Faghihi, Armaghan

2015-01-01

Background: Isoxsuprine (Vasodilan) is a beta-adrenergic that directly affects the vascular smooth muscle and results in peripheral vascular dilation. Isoxsuprine relaxes the uterine smooth muscles and is used for treatment of pre-term labor and dysmenorrhea. Isoxsuprine is used extensively in hospitals and private clinics in Iran; however, few studies have reported its safety and efficacy in the prevention of pre-term labor. Objective: The aim of this study was to assess the effect of maintenance therapy with oral isoxsuprine for the prevention of pre-term labor. Methods: We undertook a blinded prospective randomized trial of 70 women with singleton pregnancies who presented in pre-term labor between 26 to 34 weeks of gestation. After arresting the contractions with intravenous magnesium sulfate, the patients were randomized into two groups, with the treatment group receiving oral isoxsuprine until 34 weeks of gestation. Response to treatment was assessed by the progression of the pregnancies in both groups. The data were analyzed using SPSS software. Results: Our results showed that 14 (40%) of the patients in the case group and 12 (34.29%) of patients in the control group had pre-term births, and there was no significant difference between the two groups (P=0.621). Also four women (11.43%) in the case group and five women (14.29%) in the control group delivered before 34 weeks (P=0.721). Conclusion: Oral isoxsuprine was not effective as a maintenance treatment in preventing pre-term births or in delaying delivery until after 34 weeks. Larger studies are needed to identify the best treatment for pre-term labor. PMID:26396726

Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics.

PubMed

Crowley, Matthew J; Bosworth, Hayden B; Coffman, Cynthia J; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy C; Datta, Santanu K; Granger, Bradi B; Pereira, Katherine; Dolor, Rowena J; Edelman, David

2013-09-01

Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension. Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness. Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending. If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings. © 2013.

Self-managed eHealth Disease Monitoring in Children and Adolescents with Inflammatory Bowel Disease: A Randomized Controlled Trial.

PubMed

Carlsen, Katrine; Jakobsen, Christian; Houen, Gunnar; Kallemose, Thomas; Paerregaard, Anders; Riis, Lene B; Munkholm, Pia; Wewer, Vibeke

2017-03-01

To evaluate the impact of eHealth on disease activity, the need for hospital contacts, and medical adherence in children and adolescents with inflammatory bowel disease (IBD). Furthermore, to assess eHealth's influence on school attendance and quality of life (QoL). Patients with IBD, 10 to 17 years attending a public university hospital, were prospectively randomized to a 2-year open label case-controlled eHealth intervention. The eHealth-group used the web-application young.constant-care.com (YCC) on a monthly basis and in case of flare-ups, and were seen at one annual preplanned outpatient visit. The control-group continued standard visits every third month. Every 3 months, both groups had blood and fecal calprotectin tested and the following were assessed: escalation in medication, disease activity, hospital contacts, medical adherence, school absence, and QoL. Fifty-three patients in nonbiological treatment were included (27 eHealth/26 control). We found no differences between the groups regarding escalation in treatment and disease activity (symptoms, fecal calprotectin, and blood). The number of total outpatient visits (mean: eHealth 3.26, SEM 0.51; control 7.31, SEM 0.69; P < 0.0001) and IBD-related school absence (mean days: eHealth 1.6, SEM 0.5; control 16.5, SEM 4.4; P < 0.002) was significantly lower in the eHealth-group. No differences in medical adherence and QoL were found. Adherence to YCC was 81% (384 of the 475 expected entries). None of the patients or parents felt unsafe using the eHealth system. The use of eHealth in children and adolescents with IBD is feasible, does not lead to impaired disease control, and can be managed by the patients without risk of increased disease activity.

Modifiable Neighborhood Features Associated With Adolescent Homicide

PubMed Central

Culyba, Alison J.; Jacoby, Sara F.; Richmond, Therese S.; Fein, Joel A.; Hohl, Bernadette C.; Branas, Charles C.

2016-01-01

IMPORTANCE Homicide is a leading cause of adolescent mortality. To our knowledge, relatively little has been studied in terms of the association between environmental neighborhood features, such as streets, buildings, and natural surroundings, and severe violent injury among youth. OBJECTIVE To assess associations between environmental neighborhood features and adolescent homicide in order to identify targets for future place-based interventions. DESIGN, SETTING, AND PARTICIPANTS Population-based case-control study conducted in Philadelphia, Pennsylvania, from April 15, 2008, to March 31, 2014. We identified adolescents who died by homicide at 13 to 20 years of age from 2010 to 2012 while residing in Philadelphia. We used incidence-density sampling and random-digit dialing to recruit control participants ages 13 to 20 years matched on sex and indoor-outdoor location at the time of each index case participant’s homicide. EXPOSURES To obtain environmental data about modifiable features that were present in the immediate surroundings of our case and control participants, blinded field researchers used standardized techniques to photograph case and control participant outdoor locations. Photographic data were stitched together to create 360° panoramic images that were coded for 60 elements of the visible environment. MAIN OUTCOME AND MEASURE Adolescent homicide. RESULTS We enrolled 143 homicide case participants (mean [SD] age, 18.4 [1.5] years) and 155 matched control participants (mean [SD] age, 17.2 [2.1] years) who were both outdoors at the time of the homicide. In adjusted analyses, multiple features of Philadelphia streets, buildings, and natural surroundings were associated with adolescent homicide. The presence of street lighting (odds ratio [OR], 0.24; 95% CI, 0.09-0.70), illuminated walk/don’t walk signs (OR, 0.16; 95% CI, 0.03-0.92), painted marked crosswalks (OR, 0.17; 95% CI, 0.04-0.63), public transportation (OR, 0.13; 95% CI, 0.03-0.49), parks (OR, 0.09; 95% CI, 0.01-0.88), and maintained vacant lots (OR, 0.17; 95% CI, 0.03-0.81) were significantly associated with decreased odds of homicide. The odds of homicide were significantly higher in locations with stop signs (OR, 4.34; 95% CI, 1.40-13.45), security bars/gratings on houses (OR, 9.23; 95% CI, 2.45-34.80), and private bushes/plantings (OR, 3.44; 95% CI, 1.18-10.01). CONCLUSIONS AND RELEVANCE Using a population-based case-control design, we identified multiple modifiable environmental features that might be targeted in future randomized intervention trials designed to reduce youth violence by improving neighborhood context. PMID:26954939

Modifiable Neighborhood Features Associated With Adolescent Homicide.

PubMed

Culyba, Alison J; Jacoby, Sara F; Richmond, Therese S; Fein, Joel A; Hohl, Bernadette C; Branas, Charles C

2016-05-01

Homicide is a leading cause of adolescent mortality. To our knowledge, relatively little has been studied in terms of the association between environmental neighborhood features, such as streets, buildings, and natural surroundings, and severe violent injury among youth. To assess associations between environmental neighborhood features and adolescent homicide in order to identify targets for future place-based interventions. Population-based case-control study conducted in Philadelphia, Pennsylvania, from April 15, 2008, to March 31, 2014. We identified adolescents who died by homicide at 13 to 20 years of age from 2010 to 2012 while residing in Philadelphia. We used incidence-density sampling and random-digit dialing to recruit control participants ages 13 to 20 years matched on sex and indoor-outdoor location at the time of each index case participant's homicide. To obtain environmental data about modifiable features that were present in the immediate surroundings of our case and control participants, blinded field researchers used standardized techniques to photograph case and control participant outdoor locations. Photographic data were stitched together to create 360° panoramic images that were coded for 60 elements of the visible environment. Adolescent homicide. We enrolled 143 homicide case participants (mean [SD] age, 18.4 [1.5] years) and 155 matched control participants (mean [SD] age, 17.2 [2.1] years) who were both outdoors at the time of the homicide. In adjusted analyses, multiple features of Philadelphia streets, buildings, and natural surroundings were associated with adolescent homicide. The presence of street lighting (odds ratio [OR], 0.24; 95% CI, 0.09-0.70), illuminated walk/don't walk signs (OR, 0.16; 95% CI, 0.03-0.92), painted marked crosswalks (OR, 0.17; 95% CI, 0.04-0.63), public transportation (OR, 0.13; 95% CI, 0.03-0.49), parks (OR, 0.09; 95% CI, 0.01-0.88), and maintained vacant lots (OR, 0.17; 95% CI, 0.03-0.81) were significantly associated with decreased odds of homicide. The odds of homicide were significantly higher in locations with stop signs (OR, 4.34; 95% CI, 1.40-13.45), security bars/gratings on houses (OR, 9.23; 95% CI, 2.45-34.80), and private bushes/plantings (OR, 3.44; 95% CI, 1.18-10.01). Using a population-based case-control design, we identified multiple modifiable environmental features that might be targeted in future randomized intervention trials designed to reduce youth violence by improving neighborhood context.

Ste. Genevieve, Missouri Feasibility Report (Flood Control Study for Historic Ste. Genevieve - 80061). Volume 2. Appendices.

DTIC Science & Technology

1984-06-01

A greater seismic risk may be posed by two other zones: the *-."Southern Illinois - Wabash Zone and the New Madrid Zone. Earthquake ground motions...A-3 S 0I The study area is located in the Ozark Random Source Zone. This *seismotectonic zone is a region of moderate seismicity ( earthquake activity...40 inches, so that the tops of the casings are now 57 inches above the 1973 flood height. The new well casings’ elevations are approximately 395 feet

Family-based treatment of a 17-year-old twin presenting with emerging anorexia nervosa: a case study using the "Maudsley method".

PubMed

Loeb, Katharine L; Hirsch, Alicia M; Greif, Rebecca; Hildebrandt, Thomas B

2009-01-01

This article describes the successful application of family-based treatment (FBT) for a 17-year-old identical twin presenting with a 4-month history of clinically significant symptoms of anorexia nervosa (AN). FBT is a manualized treatment that has been studied in randomized controlled trials for adolescents with AN. This case study illustrates the administration of this evidence-based intervention in a clinical setting, highlighting how the best available research was used to make clinical decisions at each stage of treatment delivery.

Mediterranean Diet and Invasive Breast Cancer Risk Among Women at High Cardiovascular Risk in the PREDIMED Trial: A Randomized Clinical Trial.

PubMed

Toledo, Estefanía; Salas-Salvadó, Jordi; Donat-Vargas, Carolina; Buil-Cosiales, Pilar; Estruch, Ramón; Ros, Emilio; Corella, Dolores; Fitó, Montserrat; Hu, Frank B; Arós, Fernando; Gómez-Gracia, Enrique; Romaguera, Dora; Ortega-Calvo, Manuel; Serra-Majem, Lluís; Pintó, Xavier; Schröder, Helmut; Basora, Josep; Sorlí, José Vicente; Bulló, Mònica; Serra-Mir, Merce; Martínez-González, Miguel A

2015-11-01

Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. Participants were randomly allocated to a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies. ISRCTN.org Identifier: ISRCTN35739639.

Arnebia euchroma ointment can reduce abdominal fat thickness and abdominal circumference of overweight women: A randomized controlled study.

PubMed

Siavash, Mansour; Naseri, Mohsen; Rahimi, Mojgan

2016-01-01

Obesity is a worldwide health problem which is associated with a lot of complications. One of these comorbidities is the metabolic syndrome that is in correlation with abdominal fat thickness and waist circumference. Various methods were used to reduce abdominal fat thickness such as liposuction. A noninvasive method is the topical agent. In this study, we investigated the effectiveness of Arnebia euchroma (AE) ointment on the abdominal fat thickness. This study was a double-blind clinical trial which was done at the endocrinology clinic in Khorshid Hospital, Isfahan, Iran, in 2014. After explaining the procedure and obtaining informed consent, the candidates were randomly divided into the case and control groups. The participants of the case and control groups applied AE ointment or placebo for 6 weeks on their abdominal area. Body mass index, waist and buttock circumference, and abdominal fat thickness were measured in both case and control groups at their first visit and then at the next 2, 4, and 6 weeks. We used t -test for comparing parametric variables between groups, paired t -test for changes from baseline to final, and repeated measure ANOVA for changes at different steps. Sixty female candidates participated in this study (thirty in each group). Ten patients left the study and fifty participants finished the trial. At the end of the study, participants had a significant weight loss (2.96 ± 1.6 kg, P < 0.001) that was slightly more in the case group (3.15 ± 1.5 kg vs. 2.75 ± 1.7, P = 0.375). Abdominal circumference also decreased significantly in the participants (11.3 ± 6.7 cm, P < 0.001), but the changes were more significant in the case group (13.9 vs. 6.5 cm, P = 0.004). Similarly, abdominal fat thickness decreased significantly in the participants (2.3 ± 1.1 cm, P < 0.001), although changes were not significantly different between two groups (2.53 vs. 2.04 cm, P = 0.139). Topical AE ointment can reduce the abdominal fat thickness as well as the waist circumference without causing any side effect.

The ethics of placebo-controlled trials: methodological justifications.

PubMed

Millum, Joseph; Grady, Christine

2013-11-01

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. © 2013.

A case-control study on the association between bladder cancer and prior bladder calculus.

PubMed

Chung, Shiu-Dong; Tsai, Ming-Chieh; Lin, Ching-Chun; Lin, Herng-Ching

2013-03-15

Bladder calculus is associated with chronic irritation and inflammation. As there is substantial documentation that inflammation can play a direct role in carcinogenesis, to date the relationship between stone formation and bladder cancer (BC) remains unclear. This study aimed to examine the association between BC and prior bladder calculus using a population-based dataset. This case-control study included 2,086 cases who had received their first-time diagnosis of BC between 2001 and 2009 and 10,430 randomly selected controls without BC. Conditional logistic regressions were employed to explore the association between BC and having been previously diagnosed with bladder calculus. Of the sampled subjects, bladder calculus was found in 71 (3.4%) cases and 105 (1.1%) controls. Conditional logistic regression analysis revealed that the odds ratio (OR) of having been diagnosed with bladder calculus before the index date for cases was 3.42 (95% CI = 2.48-4.72) when compared with controls after adjusting for monthly income, geographic region, hypertension, diabetes, coronary heart disease, and renal disease, tobacco use disorder, obesity, alcohol abuse, and schistosomiasis, bladder outlet obstruction, and urinary tract infection. We further analyzed according to sex and found that among males, the OR of having been previously diagnosed with bladder calculus for cases was 3.45 (95% CI = 2.39-4.99) that of controls. Among females, the OR was 3.05 (95% CI = 1.53-6.08) that of controls. These results add to the evidence surrounding the conflicting reports regarding the association between BC and prior bladder calculus and highlight a potential target population for bladder cancer screening.

Working with a fixed operating room team on consecutive similar cases and the effect on case duration and turnover time.

PubMed

Stepaniak, Pieter S; Vrijland, Wietske W; de Quelerij, Marcel; de Vries, Guus; Heij, Christiaan

2010-12-01

If variation in procedure times could be controlled or better predicted, the cost of surgeries could be reduced through improved scheduling of surgical resources. This study on the impact of similar consecutive cases on the turnover, surgical, and procedure times tests the perception that repeating the same manual tasks reduces the duration of these tasks. We hypothesize that when a fixed team works on similar consecutive cases the result will be shorter turnover and procedure duration as well as less variation as compared with the situation without a fixed team. Case-control study. St Franciscus Hospital, a large general teaching hospital in Rotterdam, the Netherlands. Two procedures, inguinal hernia repair and laparoscopic cholecystectomy, were selected and divided across a control group and a study group. Patients were randomly assigned to the study or control group. Preparation time, surgical time, procedure time, and turnover time. For inguinal hernia repair, we found a significantly lower preparation time and 10 minutes less procedure time in the study group, as compared with the control group. Variation in the study group was lower, as compared with the control group. For laparoscopic cholecystectomy, preparation time was significantly lower in the study group, as compared with the control group. For both procedures, there was a significant decrease in turnover time. Scheduling similar consecutive cases and performing with a fixed team results in lower turnover times and preparation times. The procedure time of the inguinal hernia repair decreased significantly and has practical scheduling implications. For more complex surgery, like laparoscopic cholecystectomy, there is no effect on procedure time.

Are steroids useful to treat cerebral venous thrombosis?

PubMed

Canhão, Patrícia; Cortesão, Ana; Cabral, Marta; Ferro, José M; Stam, Jan; Bousser, Marie-Germaine; Barinagarrementeria, Fernando

2008-01-01

No randomized controlled trial has evaluated the efficacy of steroids in acute cerebral venous thrombosis (CVT). We aimed to analyze the effect of steroids on the outcome of patients in the International Study on Cerebral Veins and Dural Sinus Thrombosis (ISCVT). ISCVT is a prospective observational study that included 624 CVT patients. Death or dependence at 6 months was compared between cases (patients treated with steroids) and controls (patients not treated with steroids), using 3 designs: (1) Matched case-control study (each case matched with a control for prognostic factors); (2) Nonmatched case-control study of the ISCVT cohort; (3) Case-control study in different strata according to the number of poor prognostic variables in each patient. One hundred and fifty (24%) patients were treated with steroids. (1) In the matched case-control study, poor outcome was similar in the two groups of patients (26/146 versus 17/149, OR=1.7; 95% CI 0.9 to 3.3, P=0.119). (2) In the ISCVT cohort, no significant difference in poor outcomes was found whether patients were treated with steroids or not (26/146 versus 60/469, OR=1.5; 95% CI 0.9 to 2.4). Patients without parenchymal lesions treated with steroids had worse prognosis than those treated without steroids (8/45 versus 9/184, OR=4.2, 95% CI 1.6 to 11.6, P=0.008). (3) Treatment with steroids was not associated with a better outcome in any strata of patients according to the number of poor prognostic factors. Steroids in the acute phase of CVT were not useful and were detrimental in patients without parenchymal cerebral lesions. These results do not support the use of steroids in CVT (evidence level III).

Effects of Yoga on Physiological Indices, Anxiety and Social Functioning in Multiple Sclerosis Patients: A Randomized Trial

PubMed Central

Hasanpour-Dehkordi, Ali; Solati, Kamal

2016-01-01

Introduction Multiple sclerosis (MS) as a chronic disease could affect patients’ various domains of life. Aim This study was conducted to study the effect of yoga on the physiological indices, anxiety and social functioning of patients with MS in southwest, Iran. Materials and Methods In this clinical trial study, 60 MS patients were enrolled according to inclusion criteria and randomly assigned to two groups of 30 each. Prior to and after intervention, the patients’ vital signs were measured. For case group yoga exercises were performed three sessions a week for 12 weeks while control group performed no exercise. The data were gathered by questionnaire and analysed by descriptive and analytical statistics in SPSS. Results Prior to intervention, there was no significant difference in fatigue severity and pain between the two groups but the mean fatigue severity and pain in case group decreased compared to the control group after the intervention. Prior to intervention, there was no significant difference in mean physiological indices between the two groups but the mean physiological indices in case group decreased significantly after the intervention (p<0.05). Conclusion Yoga is likely to increase self-efficacy of MS patients through enhancing physical activity, increasing the strength of lower limbs and balance, and decreasing fatigue and pain, and finally to promote social functioning and to relieve stress and anxiety in these patients. PMID:27504387

A hybrid Bayesian hierarchical model combining cohort and case-control studies for meta-analysis of diagnostic tests: Accounting for partial verification bias.

PubMed

Ma, Xiaoye; Chen, Yong; Cole, Stephen R; Chu, Haitao

2016-12-01

To account for between-study heterogeneity in meta-analysis of diagnostic accuracy studies, bivariate random effects models have been recommended to jointly model the sensitivities and specificities. As study design and population vary, the definition of disease status or severity could differ across studies. Consequently, sensitivity and specificity may be correlated with disease prevalence. To account for this dependence, a trivariate random effects model had been proposed. However, the proposed approach can only include cohort studies with information estimating study-specific disease prevalence. In addition, some diagnostic accuracy studies only select a subset of samples to be verified by the reference test. It is known that ignoring unverified subjects may lead to partial verification bias in the estimation of prevalence, sensitivities, and specificities in a single study. However, the impact of this bias on a meta-analysis has not been investigated. In this paper, we propose a novel hybrid Bayesian hierarchical model combining cohort and case-control studies and correcting partial verification bias at the same time. We investigate the performance of the proposed methods through a set of simulation studies. Two case studies on assessing the diagnostic accuracy of gadolinium-enhanced magnetic resonance imaging in detecting lymph node metastases and of adrenal fluorine-18 fluorodeoxyglucose positron emission tomography in characterizing adrenal masses are presented. © The Author(s) 2014.

A Hybrid Bayesian Hierarchical Model Combining Cohort and Case-control Studies for Meta-analysis of Diagnostic Tests: Accounting for Partial Verification Bias

PubMed Central

Ma, Xiaoye; Chen, Yong; Cole, Stephen R.; Chu, Haitao

2014-01-01

To account for between-study heterogeneity in meta-analysis of diagnostic accuracy studies, bivariate random effects models have been recommended to jointly model the sensitivities and specificities. As study design and population vary, the definition of disease status or severity could differ across studies. Consequently, sensitivity and specificity may be correlated with disease prevalence. To account for this dependence, a trivariate random effects model had been proposed. However, the proposed approach can only include cohort studies with information estimating study-specific disease prevalence. In addition, some diagnostic accuracy studies only select a subset of samples to be verified by the reference test. It is known that ignoring unverified subjects may lead to partial verification bias in the estimation of prevalence, sensitivities and specificities in a single study. However, the impact of this bias on a meta-analysis has not been investigated. In this paper, we propose a novel hybrid Bayesian hierarchical model combining cohort and case-control studies and correcting partial verification bias at the same time. We investigate the performance of the proposed methods through a set of simulation studies. Two case studies on assessing the diagnostic accuracy of gadolinium-enhanced magnetic resonance imaging in detecting lymph node metastases and of adrenal fluorine-18 fluorodeoxyglucose positron emission tomography in characterizing adrenal masses are presented. PMID:24862512

[Clinical investigation on treatment of integrated traditional and Western medicine in hyperthyroidism with leukocytopenia induced by sulfourea drugs].

PubMed

Lu, W

1998-01-01

To seek for a safe and effective drug to treat hyperthyroidism. Sixty cases of hyperthyroidism with leukocytopenia induced by sulfourea drugs were divided into treatment and control groups by 31 cases who were treated by traditional medicine Syndrome Differentiation and 29 cases who were treated by conventional western medicine alone respectively at random. They were estimated by total effective rate, major symptoms, WBC and immunological tests after four weeks. The total effective rate in the treatment group (96.8%) was more effective than that in the control group (86.2%, P < 0.05). The symptom recovery rate in the treatment group was better than that in the control group. The WBC in both were all increased, but in the treatment group, it was better than that in the control group (P < 0.05). The positive to negative rate of thyroglobulin antibody and thyromicrosome antibody in the treatment group was better than that in the control group (P < 0.01). It can not only improve the symptoms and immune function, but also increase WBC by using western medicine in combination with traditional medicine in treating hyperthyroidism.

Acute hepatitis B outbreaks in 2 skilled nursing facilities and possible sources of transmission: North Carolina, 2009-2010.

PubMed

Seña, Arlene C; Moorman, Anne; Njord, Levi; Williams, Roxanne E; Colborn, James; Khudyakov, Yury; Drobenuic, Jan; Xia, Guo-Liang; Wood, Hattie; Moore, Zack

2013-07-01

Acute hepatitis B virus (HBV) infections have been reported in long-term care facilities (LTCFs), primarily associated with infection control breaks during assisted blood glucose monitoring. We investigated HBV outbreaks that occurred in separate skilled nursing facilities (SNFs) to determine factors associated with transmission. Outbreak investigation with case-control studies. Two SNFs (facilities A and B) in Durham, North Carolina, during 2009-2010. Residents with acute HBV infection and controls randomly selected from HBV-susceptible residents during the outbreak period. After initial cases were identified, screening was offered to all residents, with repeat testing 3 months later for HBV-susceptible residents. Molecular testing was performed to assess viral relatedness. Infection control practices were observed. Case-control studies were conducted to evaluate associations between exposures and acute HBV infection in each facility. Six acute HBV cases were identified in each SNF. Viral phylogenetic analysis revealed a high degree of HBV relatedness within, but not between, facilities. No evaluated exposures were significantly associated with acute HBV infection in facility A; those associated with infection in facility B (all odds ratios >20) included injections, hospital or emergency room visits, and daily blood glucose monitoring. Observations revealed absence of trained infection control staff at facility A and suboptimal hand hygiene practices during blood glucose monitoring and insulin injections at facility B. These outbreaks underscore the vulnerability of LTCF residents to acute HBV infection, the importance of surveillance and prompt investigation of incident cases, and the need for improved infection control education to prevent transmission.

Rethinking sources of representative controls for the conduct of case-control studies in minority populations.

PubMed

Bandera, Elisa V; Chandran, Urmila; Zirpoli, Gary; McCann, Susan E; Ciupak, Gregory; Ambrosone, Christine B

2013-05-31

Recruitment of controls remains a challenge in case-control studies and particularly in studies involving minority populations. We compared characteristics of controls recruited through random digit dialing (RDD) to those of community controls enrolled through churches, health events and other outreach sources among women of African ancestry (AA) participating in the Women's Circle of Health Study, a case-control study of breast cancer. Odds ratios and 95% confidence intervals were also computed using unconditional logistic regression to evaluate the impact of including the community controls for selected variables relevant to breast cancer and for which there were significant differences in distribution between the two control groups. Compared to community controls (n=347), RDD controls (n=207) had more years of education and higher income, lower body mass index, were more likely to have private insurance, and less likely to be single. While the percentage of nulliparous women in the two groups was similar, community controls tended to have more children, have their first child at a younger age, and were less likely to breastfeed their children. Dietary intake was similar in the two groups. Compared to census data, the combination of RDD and community controls seems to be more representative of the general population than RDD controls alone. Furthermore, the inclusion of the community group had little impact on the magnitude of risk estimates for most variables, while enhancing statistical power. Community-based recruitment was found to be an efficient and feasible method to recruit AA controls.

Answering the big questions about differential response in Colorado: safety and cost outcomes from a randomized controlled trial.

PubMed

Winokur, Marc; Ellis, Raquel; Drury, Ida; Rogers, John

2015-01-01

Over the past 20 years, jurisdictions across the United States have implemented differential response (DR), which provides child protective services with the flexibility to tailor their response to reports of child abuse or neglect based on the level of risk. Given the widespread adoption of DR, there has been an increasing demand from policymakers, practitioners, and community stakeholders to build the evidence base for this innovative child welfare approach. This study was designed to answer the big questions regarding the effect of differential response on child welfare outcomes and costs using a randomized controlled trial in five Colorado counties. Specifically, the study examined the safety outcomes and costs of families who were randomly assigned to either a family assessment response (FAR) or an investigation response (IR). According to the regression results, there were no differences between the tracks on measures of system re-involvement. However, survival analysis findings indicate that FAR families were 18% less likely, over time, to have a high risk assessment after their initial accepted referral than were IR families. The cost study revealed no differences between the tracks on initial costs for caseworker contacts, services, and out-of-home placements. However, the results suggest that follow-up costs for IR cases were significantly higher (p<0.001) than for FAR cases. The authors discuss policy and practice implications for jurisdictions considering DR. Copyright © 2014 Elsevier Ltd. All rights reserved.

Trimethoprim as Adjuvant Treatment in Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

PubMed Central

Shibre, Teshome; Alem, Atalay; Abdulahi, Abdulreshid; Araya, Mesfin; Beyero, Teferra; Medhin, Girmay; Deyassa, Negusse; Negash, Alemayehu; Nigatu, Alemayehu; Kebede, Derege

2010-01-01

Various infectious agents, such as Toxoplasma gondii, have been hypothesized to be potentially relevant etiological factors in the onset of some cases of schizophrenia. We conducted a randomized, double-blind, placebo-controlled treatment trial in an attempt to explore the hypothesis that the symptoms of schizophrenia may be related to infection of the central nervous system with toxoplasma gondii. Systematically selected patients with ongoing and at least moderately severe schizophrenia from Butajira, in rural Ethiopia, were randomly allocated to trimethoprim or placebo, which were added on to participants' regular antipsychotic treatments. Trial treatments were given for 6 months. The Positive and Negative Syndrome Scale (PANSS) was used to assess outcome. Ninety-one patients were included in the study, with 80 cases (87.9%) positive for T. gondii immunoglobulin G antibody. Seventy-nine subjects (87.0%) completed the trial. The mean age of subjects was 35.3 (SD = 8.0) years, with a mean duration of illness of 13.2 (SD = 6.7) years. Both treatment groups showed significant reduction in the overall PANSS score with no significant between-group difference. In this sample of patients with chronic schizophrenia, trimethoprim used as adjuvant treatment is not superior to placebo. However, it is not possible to draw firm conclusion regarding the etiological role of toxoplasmosis on schizophrenia based on this study because the timing and the postulated mechanisms through which toxoplasmosis produces schizophrenia are variable. PMID:19193743

Input reconstruction for networked control systems subject to deception attacks and data losses on control signals

NASA Astrophysics Data System (ADS)

Keller, J. Y.; Chabir, K.; Sauter, D.

2016-03-01

State estimation of stochastic discrete-time linear systems subject to unknown inputs or constant biases has been widely studied but no work has been dedicated to the case where a disturbance switches between unknown input and constant bias. We show that such disturbance can affect a networked control system subject to deception attacks and data losses on the control signals transmitted by the controller to the plant. This paper proposes to estimate the switching disturbance from an augmented state version of the intermittent unknown input Kalman filter recently developed by the authors. Sufficient stochastic stability conditions are established when the arrival binary sequence of data losses follows a Bernoulli random process.

South Winnipeg Integrated Geriatric Program (SWING): A Rapid Community-Response Program for the Frail Elderly

ERIC Educational Resources Information Center

Montgomery, Patrick R.; Fallis, Wendy M.

2003-01-01

The objective of this study was to compare enhanced access to geriatric assessment and case management to usual home care service provision for the frail elderly. This was a demonstration project, with randomized allocation to control or intervention groups of frail elderly persons who had been referred to the Home Care service in Winnipeg. Of the…

The Propagation of Errors in Experimental Data Analysis: A Comparison of Pre-and Post-Test Designs

ERIC Educational Resources Information Center

Gorard, Stephen

2013-01-01

Experimental designs involving the randomization of cases to treatment and control groups are powerful and under-used in many areas of social science and social policy. This paper reminds readers of the pre-and post-test, and the post-test only, designs, before explaining briefly how measurement errors propagate according to error theory. The…

Challenges of Employing E-Learning for Teaching Language: A Case of Teaching English in Iran

ERIC Educational Resources Information Center

Alizadeh, Iman

2012-01-01

The whole thrust of this study was to delve into some of the pedagogical and practical challenges intimately related to employing e-learning for teaching language. To this aim, 30 language learners targeted as the subjects of the study were randomly assigned into experimental and control groups after administering a pretest. One the one hand, the…

Oral Health among Preschool Children with Autism Spectrum Disorders: A Case-Control Study

ERIC Educational Resources Information Center

Du, Rennan Y; Yiu, Cynthia K. Y.; King, Nigel M.; Wong, Virginia C. N.; McGrath, Colman P. J.

2015-01-01

Aim: To assess and compare the oral health status of preschool children with and without autism spectrum disorders. Methods: A random sample of 347 preschool children with autism spectrum disorder was recruited from 19 Special Child Care Centres in Hong Kong. An age- and gender-matched sample was recruited from mainstream preschools as the control…

Trauma to the Psyche and Soma: A Case Study of Posttraumatic Stress Disorder and Comorbid Problems Arising from a Road Traffic Collision

ERIC Educational Resources Information Center

Wald, Jaye; Taylor, Steven

2006-01-01

Randomized controlled studies have shown that cognitive-behavioral therapies are effective for treating various forms of posttraumatic stress disorder (PTSD), with most research focusing on combat or sexual-assault-related PTSD. A challenge currently facing researchers and practitioners is to develop specialized protocols for treating other forms…

Effectiveness of a Theory-Based Risk Reduction HIV Prevention Program for Rural Vietnamese Adolescents

ERIC Educational Resources Information Center

Kaljee, Linda M.; Genberg, Becky; Riel, Rosemary; Cole, Matthew; Tho, Le Huu; Thoa, Le Thi Kim; Stanton, Bonita; Li, Xiaoming; Minh, Tuong Tan

2005-01-01

As of April 2003, 64,801 HIV cases have been documented in Vietnam (Policy Project 2003), 53.9% of which are among individuals 20-29 years of age. Although HIV education efforts have increased, there remains a need for proven effective programs. We present findings from a randomized-controlled effectiveness trial of an HIV prevention program for…

Prospective Evaluation of Intraprostatic Inflammation and Focal Atrophy as a Predictor of Risk of High-Grade Prostate Cancer and Recurrence after Prostatectomy

DTIC Science & Technology

2014-07-01

the two trials. The expected sample size for this work was 100 cases and 200 controls. Tissue was sufficient for 291 of the men (Task 2 completed in...not collected in SELECT), physical activity (PCPT [not collected in SELECT), cigarette smoking status at randomization (SELECT), use of aspirin

Relationship between Early Familial Influences and Personality Traits in Relation to Career Success Outcomes of African American Women

ERIC Educational Resources Information Center

Gardner, Keeba G.

2010-01-01

This study will examine the relationship between career success outcomes of African American women and early familial factors, as well as personality traits. Using a cross-sectional case-control design. the study will use participants who self-identified as African American with two African American parents. They will be randomly selected from a…

Posttraumatic Stress Disorder, Traumatic Brain Injury, and Suicide Attempt History among Veterans Receiving Mental Health Services

ERIC Educational Resources Information Center

Brenner, Lisa A.; Betthauser, Lisa M.; Homaifar, Beeta Y.; Villarreal, Edgar; Harwood, Jeri E. F.; Staves, Pamela J.; Huggins, Joseph A.

2011-01-01

History of posttraumatic stress disorder (PTSD) or traumatic brain injury (TBI) has been found to increase risk of suicidal behavior. The association between suicide attempt history among veterans with PTSD and/or TBI was explored. Cases (N = 81) and 2:1 matched controls (N = 160) were randomly selected from a Veterans Affairs Medical Center…

Ketamine for cancer pain: what is the evidence?

PubMed

Jonkman, Kelly; van de Donk, Tine; Dahan, Albert

2017-06-01

In this review, we assess the benefit of ketamine in the treatment of terminal cancer pain that is refractory to opioid treatment and/or complicated by neuropathy. While randomized controlled trials consistently show lack of clinical efficacy of ketamine in treating cancer pain, a large number of open-label studies and case series show benefit. Ketamine is an N-methyl-D-aspartate receptor antagonist that at low-dose has effective analgesic properties. In cancer pain, ketamine is usually prescribed as adjuvant to opioid therapy when pain becomes opioid resistant or when neuropathic pain symptoms dominate the clinical picture. A literature search revealed four randomized controlled trials that examined the benefit of oral, subcutaneous or intravenous ketamine in opioid refractory cancer pain. None showed clinically relevant benefit in relieving pain or reducing opioid consumption. This suggests absence of evidence of benefit for ketamine as adjuvant analgesic in cancer pain. These findings contrast the benefit from ketamine observed in a large number of open-label studies and (retrospective) case series. We relate the opposite outcomes to methodological issues. The complete picture is such that there is still insufficient evidence to state with certainty that ketamine is not effective in cancer pain.

Piecewise exponential survival times and analysis of case-cohort data.

PubMed

Li, Yan; Gail, Mitchell H; Preston, Dale L; Graubard, Barry I; Lubin, Jay H

2012-06-15

Case-cohort designs select a random sample of a cohort to be used as control with cases arising from the follow-up of the cohort. Analyses of case-cohort studies with time-varying exposures that use Cox partial likelihood methods can be computer intensive. We propose a piecewise-exponential approach where Poisson regression model parameters are estimated from a pseudolikelihood and the corresponding variances are derived by applying Taylor linearization methods that are used in survey research. The proposed approach is evaluated using Monte Carlo simulations. An illustration is provided using data from the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study of male smokers in Finland, where a case-cohort study of serum glucose level and pancreatic cancer was analyzed. Copyright © 2012 John Wiley & Sons, Ltd.

Effectiveness of case management for homeless persons: a systematic review.

PubMed

de Vet, Renée; van Luijtelaar, Maurice J A; Brilleslijper-Kater, Sonja N; Vanderplasschen, Wouter; Beijersbergen, Mariëlle D; Wolf, Judith R L M

2013-10-01

We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized controlled trials or quasi-experimental studies comparing case management to other services. We found little evidence for the effectiveness of ICM. SCM improved housing stability, reduced substance use, and removed employment barriers for substance users. ACT improved housing stability and was cost-effective for mentally ill and dually diagnosed persons. CTI showed promise for housing, psychopathology, and substance use and was cost-effective for mentally ill persons. More research is needed on how case management can most effectively support rapid-rehousing approaches to homelessness.

Effectiveness of Case Management for Homeless Persons: A Systematic Review

PubMed Central

de Vet, Renée; van Luijtelaar, Maurice J. A.; Brilleslijper-Kater, Sonja N.; Vanderplasschen, Wouter; Beijersbergen, Mariëlle D.

2013-01-01

We reviewed the literature on standard case management (SCM), intensive case management (ICM), assertive community treatment (ACT), and critical time intervention (CTI) for homeless adults. We searched databases for peer-reviewed English articles published from 1985 to 2011 and found 21 randomized controlled trials or quasi-experimental studies comparing case management to other services. We found little evidence for the effectiveness of ICM. SCM improved housing stability, reduced substance use, and removed employment barriers for substance users. ACT improved housing stability and was cost-effective for mentally ill and dually diagnosed persons. CTI showed promise for housing, psychopathology, and substance use and was cost-effective for mentally ill persons. More research is needed on how case management can most effectively support rapid-rehousing approaches to homelessness. PMID:23947309

Optimal control of hydroelectric facilities

NASA Astrophysics Data System (ADS)

Zhao, Guangzhi

This thesis considers a simple yet realistic model of pump-assisted hydroelectric facilities operating in a market with time-varying but deterministic power prices. Both deterministic and stochastic water inflows are considered. The fluid mechanical and engineering details of the facility are described by a model containing several parameters. We present a dynamic programming algorithm for optimizing either the total energy produced or the total cash generated by these plants. The algorithm allows us to give the optimal control strategy as a function of time and to see how this strategy, and the associated plant value, varies with water inflow and electricity price. We investigate various cases. For a single pumped storage facility experiencing deterministic power prices and water inflows, we investigate the varying behaviour for an oversimplified constant turbine- and pump-efficiency model with simple reservoir geometries. We then generalize this simple model to include more realistic turbine efficiencies, situations with more complicated reservoir geometry, and the introduction of dissipative switching costs between various control states. We find many results which reinforce our physical intuition about this complicated system as well as results which initially challenge, though later deepen, this intuition. One major lesson of this work is that the optimal control strategy does not differ much between two differing objectives of maximizing energy production and maximizing its cash value. We then turn our attention to the case of stochastic water inflows. We present a stochastic dynamic programming algorithm which can find an on-average optimal control in the face of this randomness. As the operator of a facility must be more cautious when inflows are random, the randomness destroys facility value. Following this insight we quantify exactly how much a perfect hydrological inflow forecast would be worth to a dam operator. In our final chapter we discuss the challenging problem of optimizing a sequence of two hydro dams sharing the same river system. The complexity of this problem is magnified and we just scratch its surface here. The thesis concludes with suggestions for future work in this fertile area. Keywords: dynamic programming, hydroelectric facility, optimization, optimal control, switching cost, turbine efficiency.

Selective decontamination of the digestive tract in gastrointestinal surgery: useful in infection prevention? A systematic review.

PubMed

Abis, Gabor S A; Stockmann, Hein B A C; van Egmond, Marjolein; Bonjer, Hendrik J; Vandenbroucke-Grauls, Christina M J E; Oosterling, Steven J

2013-12-01

Gastrointestinal surgery is associated with a high incidence of infectious complications. Selective decontamination of the digestive tract is an antimicrobial prophylaxis regimen that aims to eradicate gastrointestinal carriage of potentially pathogenic microorganisms and represents an adjunct to regular prophylaxis in surgery. Relevant studies were identified using bibliographic searches of MEDLINE, EMBASE, and the Cochrane database (period from 1970 to November 1, 2012). Only studies investigating selective decontamination of the digestive tract in gastrointestinal surgery were included. Two randomized clinical trials and one retrospective case-control trial showed significant benefit in terms of infectious complications and anastomotic leakage in colorectal surgery. Two randomized controlled trials in esophageal surgery and two randomized clinical trials in gastric surgery reported lower levels of infectious complications. Selective decontamination of the digestive tract reduces infections following esophageal, gastric, and colorectal surgeries and also appears to have beneficial effects on anastomotic leakage in colorectal surgery. We believe these results provide the basis for a large multicenter prospective study to investigate the role of selective decontamination of the digestive tract in colorectal surgery.

Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

PubMed Central

Jerosch-Herold, C.; Houghton, J.; Miller, L.; Shepstone, L.

2016-01-01

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning (n = 52) or control (n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II PMID:27402282

[Risk factors associated with non-alcoholic fatty liver disease: a case-control study].

PubMed

Caballería, Llorenç; Arteaga, Ingrid; Pera, Guillem; Rodríguez, Lluís; Alumà, Alba; Auladell, Maria Antònia; Torán, Pere

2013-09-21

To establish the factors associated with the presence of non-alcoholic fatty liver disease (NAFLD) and evaluate the influence of each component constituting the metabolic syndrome (MS) and the risk of developing NAFLD. We performed a multicenter, population-based, observational, analytical study of cases and controls. A case was defined as any patient fulfilling the inclusion criteria and presenting NAFLD by abdominal echography for any reason. A control was randomly selected for each case, from the same health center and of the same age and sex. All the cases underwent anamnesis, physical examination, complete biochemical analyses and determination of MS according to the National Cholesterol Education Program-Adult Treatment Panel III criteria. All the controls also underwent an abdominal echography. We included 327 cases and 377 controls with a mean age of 56 ± 12 years for the cases and of 55 ± 13 years for the controls (range: 17 and 80 years); 52.0% of the cases were males and 49.1% of males were controls. The risk factors associated with NAFLD were obesity (odds ratio [OR] 3.82, 95% confidence interval [95% CI] 2.19-6.66), MS (OR 1.73, 95% CI 1.09-2.75), insulin resistance (OR 3.65, 95% CI 2.18-6.12), and an increase in alanine aminotransferase (ALT) (OR 4.72, 95% CI 2.58-8.61) and gamma glutamyl transferase values (GGT) (OR 1.95, 95% CI 1.14-3.34). The components of the MS best predicting NAFLD were hyperglycemia (OR 1.65, 95% CI1.06-2.56) and triglyceride values (OR 1.75, 95% CI1.13-2.72). The independent variables associated with NAFLD were obesity, insulin resistance and elevated ALT and GGT. The components of MS best predicting NAFLD were hyperglycemia and an increase in triglyceride values. Copyright © 2012 Elsevier España, S.L. All rights reserved.

Association of vitamin D levels and risk of ovarian cancer: a Mendelian randomization study.

PubMed

Ong, Jue-Sheng; Cuellar-Partida, Gabriel; Lu, Yi; Fasching, Peter A; Hein, Alexander; Burghaus, Stefanie; Beckmann, Matthias W; Lambrechts, Diether; Van Nieuwenhuysen, Els; Vergote, Ignace; Vanderstichele, Adriaan; Anne Doherty, Jennifer; Anne Rossing, Mary; Chang-Claude, Jenny; Eilber, Ursula; Rudolph, Anja; Wang-Gohrke, Shan; Goodman, Marc T; Bogdanova, Natalia; Dörk, Thilo; Dürst, Matthias; Hillemanns, Peter; Runnebaum, Ingo B; Antonenkova, Natalia; Butzow, Ralf; Leminen, Arto; Nevanlinna, Heli; Pelttari, Liisa M; Edwards, Robert P; Kelley, Joseph L; Modugno, Francesmary; Moysich, Kirsten B; Ness, Roberta B; Cannioto, Rikki; Høgdall, Estrid; Høgdall, Claus K; Jensen, Allan; Giles, Graham G; Bruinsma, Fiona; Kjaer, Susanne K; Hildebrandt, Michelle At; Liang, Dong; Lu, Karen H; Wu, Xifeng; Bisogna, Maria; Dao, Fanny; Levine, Douglas A; Cramer, Daniel W; Terry, Kathryn L; Tworoger, Shelley S; Stampfer, Meir; Missmer, Stacey; Bjorge, Line; Salvesen, Helga B; Kopperud, Reidun K; Bischof, Katharina; Aben, Katja Kh; Kiemeney, Lambertus A; Massuger, Leon Fag; Brooks-Wilson, Angela; Olson, Sara H; McGuire, Valerie; Rothstein, Joseph H; Sieh, Weiva; Whittemore, Alice S; Cook, Linda S; Le, Nhu D; Gilks, C Blake; Gronwald, Jacek; Jakubowska, Anna; Lubiński, Jan; Kluz, Tomasz; Song, Honglin; Tyrer, Jonathan P; Wentzensen, Nicolas; Brinton, Louise; Trabert, Britton; Lissowska, Jolanta; McLaughlin, John R; Narod, Steven A; Phelan, Catherine; Anton-Culver, Hoda; Ziogas, Argyrios; Eccles, Diana; Campbell, Ian; Gayther, Simon A; Gentry-Maharaj, Aleksandra; Menon, Usha; Ramus, Susan J; Wu, Anna H; Dansonka-Mieszkowska, Agnieszka; Kupryjanczyk, Jolanta; Timorek, Agnieszka; Szafron, Lukasz; Cunningham, Julie M; Fridley, Brooke L; Winham, Stacey J; Bandera, Elisa V; Poole, Elizabeth M; Morgan, Terry K; Risch, Harvey A; Goode, Ellen L; Schildkraut, Joellen M; Pearce, Celeste L; Berchuck, Andrew; Pharoah, Paul Dp; Chenevix-Trench, Georgia; Gharahkhani, Puya; Neale, Rachel E; Webb, Penelope M; MacGregor, Stuart

2016-10-01

In vitro and observational epidemiological studies suggest that vitamin D may play a role in cancer prevention. However, the relationship between vitamin D and ovarian cancer is uncertain, with observational studies generating conflicting findings. A potential limitation of observational studies is inadequate control of confounding. To overcome this problem, we used Mendelian randomization (MR) to evaluate the association between single nucleotide polymorphisms (SNPs) associated with circulating 25-hydroxyvitamin D [25(OH)D] concentration and risk of ovarian cancer. We employed SNPs with well-established associations with 25(OH)D concentration as instrumental variables for MR: rs7944926 (DHCR7), rs12794714 (CYP2R1) and rs2282679 (GC). We included 31 719 women of European ancestry (10 065 cases, 21 654 controls) from the Ovarian Cancer Association Consortium, who were genotyped using customized Illumina Infinium iSelect (iCOGS) arrays. A two-sample (summary data) MR approach was used and analyses were performed separately for all ovarian cancer (10 065 cases) and for high-grade serous ovarian cancer (4121 cases). The odds ratio for epithelial ovarian cancer risk (10 065 cases) estimated by combining the individual SNP associations using inverse variance weighting was 1.27 (95% confidence interval: 1.06 to 1.51) per 20 nmol/L decrease in 25(OH)D concentration. The estimated odds ratio for high-grade serous epithelial ovarian cancer (4121 cases) was 1.54 (1.19, 2.01). Genetically lowered 25-hydroxyvitamin D concentrations were associated with higher ovarian cancer susceptibility in Europeans. These findings suggest that increasing plasma vitamin D levels may reduce risk of ovarian cancer. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Is Surgery for Displaced, Midshaft Clavicle Fractures in Adults Cost-Effective? Results Based on a Multicenter Randomized Controlled Trial

PubMed Central

2010-01-01

Objectives To determine the cost-effectiveness of open reduction internal fixation (ORIF) of displaced, midshaft clavicle fractures in adults. Design Formal cost-effectiveness analysis based on a prospective, randomized controlled trial. Setting Eight hospitals in Canada (seven university affiliated and one community hospital) Patients/Participants 132 adults with acute, completely displaced, midshaft clavicle fractures Intervention Clavicle ORIF versus nonoperative treatment Main Outcome Measurements Utilities derived from SF-6D Results The base-case cost per quality adjusted life year (QALY) gained for ORIF was $65,000. Cost-effectiveness improved to $28,150/QALY gained when the functional benefit from ORIF was assumed to be permanent, with cost per QALY gained falling below $50,000 when the functional advantage persisted for 9.3 years or more. In other sensitivity analyses, the cost per QALY gained for ORIF fell below $50,000 when ORIF cost less than $10,465 (base case cost $13,668) or the long-term utility difference between nonoperative treatment and ORIF was greater than 0.034 (base-case difference 0.014). Short-term disutility associated with fracture healing also affected cost-effectiveness, with the cost per QALY gained for ORIF falling below $50,000 when the utility of a fracture treated nonoperatively prior to union was less than 0.617 (base-case utility 0.706) or when nonoperative treatment increased the time to union by 20 weeks (base-case difference 12 weeks). Conclusions The cost-effectiveness of ORIF after acute clavicle fracture depended on the durability of functional advantage for ORIF compared to nonoperative treatment. When functional benefits persisted for more than 9 years, ORIF had favorable value compared with many accepted health interventions. PMID:20577073

Appropriate anesthesia regimen to control sevoflurane-induced emergence agitation in children; propofol-lidocaine and thiopental sodium-lidocaine: a randomized controlled trial.

PubMed

Rahimzadeh, Poupak; Faiz, Seyed Hamid Reza; Alebouyeh, Mahmood Reza; Dasian, Azadeh; Sayarifard, Azadeh

2014-07-01

Emergence Agitation (EA) is a common problem in pediatric anesthesia. The current study evaluated the effect of intravenous lidocaine combined with propofol or thiopental sodium to control EA by sevoflurane in children. The current study aimed to compare the effectiveness of two anesthesia regimen propofol-lidocaine and thiopental sodium lidocaine to control sevoflurane-induced emergence agitation in children. The study enrolled 120 children aged 12 to 36 months with retinoblastoma who underwent induction of anesthesia with sevoflurane for Eye Examination Under Anesthesia (EUA). Sampling was done at Rasoul-Akram Hospital in Tehran, Iran. The subjects were randomly assigned into four groups including: group one (thiopental sodium-lidocaine [TL]), group two (thiopental sodium-saline [TS]), group three (propofol-lidocaine [PL]), and group four (propofol-saline [PS]). Emergence agitation was assessed by using a five-point scoring scale, every 10 minutes during the first 30 minutes after admission to the recovery room. EA occurred in 24 cases (20%) of children. Incidence of EA in the TS, TL, PS, and PL groups were 21 (70%), 2 (6.7%), 1 (3.3%), and 0 (0%), respectively (P < 0.001). Nausea and vomiting after anesthesia did not occur in any of the patients. After removal of the endotracheal tube, laryngospasm complication occurrence in the TS group (10 cases) was higher than the other groups and no statistically significant difference was observed (P = 0.1). Propofol-lidocaine anesthesia regimen was more effective to control the pediatric emergence agitation than the other combinations.

Two-year outcome of team-based intensive case management for patients with schizophrenia.

PubMed

Aberg-Wistedt, A; Cressell, T; Lidberg, Y; Liljenberg, B; Osby, U

1995-12-01

Two-year outcomes of patients with schizophrenic disorders who were assigned to an intensive, team-based case management program and patients who received standard psychiatric services were assessed. The case management model featured increased staff contact time with patients, rehabilitation plans based on patients' expressed needs, and patients' attendance at team meetings where their rehabilitation plan was discussed. Forty patients were randomly assigned to either the case management group or the control group that received standard services. Patients' use of emergency and inpatient services, their quality of life, the size of their social networks, and their relatives' burden of care were assessed at assignment to the study groups and at two-year follow-up. Patients in the case management group had significantly fewer emergency visits compared with the two years before the study, and their relatives reported significantly reduced burden of care associated with relationships with psychiatric services over the two-year period. The size of patients' social networks increased for the case management group and decreased for the control group. A team-based intensive case management model is an effective intervention in the rehabilitation of patients with chronic schizophrenia.

Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial.

PubMed

Celiker Tosun, O; Kaya Mutlu, E; Ergenoglu, A M; Yeniel, A O; Tosun, G; Malkoc, M; Askar, N; Itil, I M

2015-06-01

To determine whether symptoms of urinary incontinence is reduced by pelvic floor muscle training, to determine whether urinary incontinence can be totally eliminated by strengthening the pelvic floor muscle to grade 5 on the Oxford scale. Prospective randomized controlled clinical trial. Outpatient urogynecology department. One hundred thirty cases with stress and mixed urinary incontinence. All participants were randomly allocated to the pelvic floor muscle training group or control group. A 12-week home based exercise program, prescribed individually, was performed by the pelvic floor muscle training group. Urinary incontinence symptoms (Incontinence Impact Questionnaire-7, Urogenital Distress Inventory-6, bladder diary, stop test and pad test) were assessed, and the pelvic floor muscle strength was measured for (PERFECT testing, perineometric and ultrasound) all participants before and after 12 weeks of treatment. The pelvic floor muscle training group had significant improvement in their symptoms of urinary incontinence (P=0.001) and an increase in pelvic floor muscle strength (P=0.001, by the dependent t test) compared with the control group. All the symptoms of urinary incontinence were significantly decreased in the patients that had reached pelvic floor muscle strength of grade 5 and continued the pelvic floor muscle training (P<0.05). The study demonstrated that pelvic floor muscle training is effective in reducing the symptoms of stress and mixed urinary incontinence and in increasing pelvic floor muscle strength. © The Author(s) 2014.

Working conditions of bus drivers in the private sector and bus crashes in Kandy district, Sri Lanka: a case-control study.

PubMed

Jayatilleke, A U; Nakahara, S; Dharmaratne, S D; Jayatilleke, A C; Poudel, K C; Jimba, M

2009-04-01

To explore the effects of working conditions of private-bus drivers on bus crashes in Kandy district, Sri Lanka. A case-control study was carried out from August to September 2006. All private-bus drivers registered in Kandy district and involved in crashes reported to the police between November 2005 and April 2006 (n = 63) were selected as cases. Two control groups were included: private-bus drivers working on the same routes as the case drivers (n = 90) and private-bus drivers selected randomly from other routes of the district (n = 111). Data were collected using an anonymous self-administered questionnaire. Associations between working conditions and crashes were analysed using logistic regression. A strong association was observed between drivers' disagreements about working hours and bus crashes (matched controls, adjusted odds ratio (AOR) 5.98, 95% CI 1.02 to 34.90; unmatched controls, AOR 18.74, 95% CI 2.00 to 175.84). A significant association was also observed between low salaries (