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Sample records for randomized trials electronic

  1. Novel electronic refreshers for cardiopulmonary resuscitation: a randomized controlled trial

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    Magura Stephen

    2012-11-01

    Full Text Available Abstract Background Currently the American Red Cross requires that individuals renew their cardiopulmonary resuscitation (CPR certification annually; this often requires a 4- to 8-hour refresher course. Those trained in CPR often show a decrease in essential knowledge and skills within just a few months after training. New electronic means of communication have expanded the possibilities for delivering CPR refreshers to members of the general public who receive CPR training. The study’s purpose was to determine the efficacy of three novel CPR refreshers - online website, e-mail and text messaging – for improving three outcomes of CPR training - skill retention, confidence for using CPR and intention to use CPR. These three refreshers may be considered “novel” in that they are not typically used to refresh CPR knowledge and skills. Methods The study conducted two randomized clinical trials of the novel CPR refreshers. A mailed brochure was a traditional, passive refresher format and served as the control condition. In Trial 1, the refreshers were delivered in a single episode at 6 months after initial CPR training. In Trial 2, the refreshers were delivered twice, at 6 and 9 months after initial CPR training, to test the effect of a repeated delivery. Outcomes for the three novel refreshers vs. the mailed brochure were determined at 12 months after initial CPR training. Results Assignment to any of three novel refreshers did not improve outcomes of CPR training one year later in comparison with receiving a mailed brochure. Comparing outcomes for subjects who actually reviewed some of the novel refreshers vs. those who did not indicated a significant positive effect for one outcome, confidence for performing CPR. The website refresher was associated with increased behavioral intent to perform CPR. Stated satisfaction with the refreshers was relatively high. The number of episodes of refreshers (one vs. two did not have a significant effect

  2. Cluster randomized trials utilizing primary care electronic health records : methodological issues in design, conduct, and analysis (eCRT Study)

    NARCIS (Netherlands)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-01-01

    BACKGROUND: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical

  3. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records

    NARCIS (Netherlands)

    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C

    BACKGROUND AND PURPOSE: The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using

  4. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

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    Quan Sherman

    2007-10-01

    Full Text Available Abstract Background Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in preventable adverse drug events have been shown to occur most often at the stages of ordering and administration. This paper describes the protocol for a pragmatic trial of electronic prescribing to reduce prescription error. The trial was designed to overcome the limitations associated with traditional study design. Design This study was designed as a 65-week, cluster randomized, parallel study. Methods The trial was conducted within ambulatory outpatient clinics in an academic tertiary care centre in Ontario, Canada. The electronic prescribing software for the study is a Canadian electronic prescribing software package which provides physician prescription entry with decision support at the point of care. Using a handheld computer (PDA the physician selects medications using an error minimising menu-based pick list from a comprehensive drug database, create specific prescription instructions and then transmit the prescription directly and electronically to a participating pharmacy via facsimile or to the physician's printer using local area wireless technology. The unit of allocation and randomization is by 'week', i.e. the system is "on" or "off" according to the randomization scheme and the unit of analysis is the prescription, with adjustment for clustering of patients within practitioners. Discussion This paper describes the protocol for a pragmatic cluster randomized trial of point-of-care electronic prescribing, which was specifically designed to overcome the limitations associated with traditional study design. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00252395

  5. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

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    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

    2014-07-01

    The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

  6. Randomized trial of an electronic asthma monitoring system among New York City children.

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    Jacobson, Judith S; Lieblein, Andrea; Fierman, Arthur H; Fishkin, Edward R; Hutchinson, Vincent E; Rodriguez, Luis; Serebrisky, Denise; Chau, Michelle; Saperstein, Arnold

    2009-11-01

    To test the efficacy of an electronic asthma monitoring system (AMS) to reduce pediatric emergency department (ED) visits and hospitalizations for asthma. Randomized clinical trial. Families of pediatric patients with asthma aged 8 to 17 years were recruited at 6 medical centers. Children were randomly assigned to the American Medical Alert Corporation pediatric AMS or a paper diary. The numbers of and costs associated with ED visits and hospitalizations for the 2 groups in the year following randomization were compared using t tests of statistical significance. Of 59 children recruited to the trial, 29 were randomized to the AMS and 30 to the diary. The 2 groups were similar in demographic and clinical characteristics. During their study year, 24 AMS group members logged on a mean (SD) of 211.0 (117.3) days; 13 diary group members provided data on a mean (SD) of 136.6 (128.0) days. During the 32 months that the study was in progress, the case managers logged on a mean (SD) of 171.0 (97.2) days. Overall, 35 children had at least 1 ED visit, but only 7 children were hospitalized. The 2 groups had no statistically significant differences in the numbers of or charges associated with ED visits or hospitalizations. Electronic devices are being developed to make chronic disease management easier for patients and their families, but they should not be adopted without careful study, including randomized trials, to ascertain their use, costs, and benefits.

  7. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation

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    Alexa A. Lopez

    2016-03-01

    Full Text Available Abstract Background This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Methods Participants (N = 520 will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Discussion Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. Trial registration TRN: NCT02342795 , registered December 16, 2014.

  8. Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial.

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    Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F

    2010-08-01

    To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

  9. Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study).

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    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-06-11

    There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). Two trials were completed in primary care: one aimed to reduce inappropriate antibiotic prescribing for acute respiratory infection; the other aimed to increase physician adherence with secondary prevention interventions after first stroke. The paper draws on documentary records and trial datasets to report on the methodological experience with respect to research ethics and research governance approval, general practice recruitment and allocation, sample size calculation and power, intervention implementation, and trial analysis. We obtained research governance approvals from more than 150 primary care organizations in England, Wales, and Scotland. There were 104 CPRD general practices recruited to the antibiotic trial and 106 to the stroke trial, with the target number of practices being recruited within six months. Interventions were installed into practice information systems remotely over the internet. The mean number of participants per practice was 5,588 in the antibiotic trial and 110 in the stroke trial, with the coefficient of variation of practice sizes being 0.53 and 0.56 respectively. Outcome measures showed substantial correlations between the 12 months before, and after intervention, with coefficients ranging from 0.42 for diastolic blood pressure to 0.91 for proportion of consultations with antibiotics prescribed, defining practice and participant eligibility for analysis requires careful consideration. Cluster randomized trials may be performed efficiently in large samples from UK general practices using the electronic health records of a primary care database. The geographical dispersal of trial sites presents a difficulty for

  10. Impact of Exposure to Electronic Cigarette Advertising on Susceptibility and Trial of Electronic Cigarettes and Cigarettes in US Young Adults: A Randomized Controlled Trial.

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    Villanti, Andrea C; Rath, Jessica M; Williams, Valerie F; Pearson, Jennifer L; Richardson, Amanda; Abrams, David B; Niaura, Raymond S; Vallone, Donna M

    2016-05-01

    This study assessed the impact of brief exposure to four electronic cigarette (e-cigarette) print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes in US young adults. A randomized controlled trial was conducted in a national sample of young adults from an online panel survey in 2013. Participants were randomized to ad exposure or control. Curiosity, intentions, and perceptions regarding e-cigarettes were assessed post-exposure and e-cigarette and cigarette use at 6-month follow-up. Analyses were conducted in 2014. Approximately 6% of young adults who had never used an e-cigarette at baseline tried an e-cigarette at 6-month follow-up, half of whom were current cigarette smokers at baseline. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette (18.3% exposed vs. 11.3% unexposed, AOR = 1.63, 95% CI = 1.18, 2.26) among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up (3.6% exposed vs. 1.2% unexposed, AOR = 2.85; 95% CI = 1.07, 7.61) among never users of cigarettes and e-cigarettes. Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users, nor cigarette use among smokers over time. Curiosity mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users. Exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Future studies are needed to examine the net effect of curiosity and trial of e-cigarettes on longer-term patterns of tobacco use. This randomized trial provides the first evidence of the effect of e-cigarette advertising on a behavioral outcome in young adults. Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users and greater likelihood of e-cigarette trial at follow-up in a small number of never e

  11. Handheld vs. laptop computers for electronic data collection in clinical research: a crossover randomized trial.

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    Haller, Guy; Haller, Dagmar M; Courvoisier, Delphine S; Lovis, Christian

    2009-01-01

    To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers. The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment. The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard. The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p laptop compared to 8.4 per 1,000 with the handheld computer (p laptop was used (p laptop easier, faster and more satisfying to use than the handheld computer. Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare workers, unfamiliar with computer technologies, for self-reporting or research data collection processes.

  12. An electronic documentation system improves the quality of admission notes: a randomized trial.

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    Jamieson, Trevor; Ailon, Jonathan; Chien, Vince; Mourad, Ophyr

    2017-01-01

    There are concerns that structured electronic documentation systems can limit expressivity and encourage long and unreadable notes. We assessed the impact of an electronic clinical documentation system on the quality of admission notes for patients admitted to a general medical unit. This was a prospective randomized crossover study comparing handwritten paper notes to electronic notes on different patients by the same author, generated using a semistructured electronic admission documentation system over a 2-month period in 2014. The setting was a 4-team, 80-bed general internal medicine clinical teaching unit at a large urban academic hospital. The quality of clinical documentation was assessed using the QNOTE instrument (best possible score = 100), and word counts were assessed for free-text sections of notes. Twenty-one electronic-paper note pairs (42 notes) written by 21 authors were randomly drawn from a pool of 303 eligible notes. Overall note quality was significantly higher in electronic vs paper notes (mean 90 vs 69, P quality of free-text subsections (History of Present Illness and Impression and Plan) was significantly higher in the electronic vs paper notes (mean 93 vs 78, P system improved both the quality of free-text content and the overall quality of admission notes. Authors wrote more in the free-text sections of electronic documents as compared to paper versions. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  13. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

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    Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

    2015-10-01

    The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

  14. A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

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    Scott R Evans

    Full Text Available OBJECTIVES: To examine the efficacy and safety of Prosaptide (PRO for the treatment of painful HIV-associated sensory neuropathies (HIV-SN. DESIGN: A randomized, double-blind, placebo-controlled, multicenter study in participants with sensory neuropathy. Pain modulating therapy was discontinued prior to baseline. Participants were stratified by sural sensory nerve action potential (SNAP amplitude. Participants were trained to use an electronic diary (ED to record pain. SETTING: Peripheral neuropathies are common complications of HIV infection. The pathogenesis is unknown and currently treatments are restricted to symptomatic measures. We examined PRO against placebo (PBO for treatment of painful HIV-SN and performed a post-hoc evaluation of an electronic diary (ED to record HIV-associated neuropathic pain. PARTICIPANTS: Eligible participants included adults with neurologist-confirmed painful HIV-SN. INTERVENTIONS: 2, 4, 8, or 16 mg/d PRO or PBO administered via subcutaneous (SC injection for six weeks. Neurotoxic antiretroviral drug usage was held constant. OUTCOME MEASURES: Changes from baseline in the weekly average of evaluable daily random prompts measuring pain using the Gracely pain scale and adverse events. RESULTS: 237 participants were randomized. The study was stopped after a planned futility analysis. There were no between-group differences in the frequency of adverse events or laboratory toxicities. The 6-week mean (sd Gracely pain scale changes were -0.12 (0.23, -0.24 (0.35, -0.15 (0.32, -0.18 (0.34, and -0.18 (0.32 for the 2, 4, 8, 16 mg, and PBO arms respectively. A similar variability of pain changes recorded using the ED were noted compared to previous trials that used paper collection methods. CONCLUSIONS: 6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain. Use of an ED to record neuropathic pain is novel in HIV-SN, resulted in reasonable compliance in recording pain data, but did

  15. Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.

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    Zhang, Jing; Sun, Lei; Liu, Yu; Wang, Hongyi; Sun, Ningling; Zhang, Puhong

    2017-03-08

    Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely

  16. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

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    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-12-23

    The clinicaltrials.gov identifying number for the article titled "Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial" is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

  17. Effect of Access to an Electronic Medical Resource on Performance Characteristics of a Certification Examination: A Randomized Controlled Trial.

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    Lipner, Rebecca S; Brossman, Bradley G; Samonte, Kelli M; Durning, Steven J

    2017-09-05

    Electronic resources are increasingly used in medical practice. Their use during high-stakes certification examinations has been advocated by many experts, but whether doing so would affect the capacity to differentiate between high and low abilities is unknown. To determine the effect of electronic resources on examination performance characteristics. Randomized controlled trial. Medical certification program. 825 physicians initially certified by the American Board of Internal Medicine (ABIM) who passed the Internal Medicine Certification examination or sat for the Internal Medicine Maintenance of Certification (IM-MOC) examination in 2012 to 2015. Participants were randomly assigned to 1 of 4 conditions: closed book using typical or additional time, or open book (that is, UpToDate [Wolters Kluwer]) using typical or additional time. All participants took the same modified version of the IM-MOC examination. Primary outcomes included item difficulty (how easy or difficult the question was), item discrimination (how well the question differentiated between high and low abilities), and average question response time. Secondary outcomes included examination dimensionality (that is, the number of factors measured) and test-taking strategy. Item response theory was used to calculate question characteristics. Analysis of variance compared differences among conditions. Closed-book conditions took significantly less time than open-book conditions (mean, 79.2 seconds [95% CI, 78.5 to 79.9 seconds] vs. 110.3 seconds [CI, 109.2 to 111.4 seconds] per question). Mean discrimination was statistically significantly higher for open-book conditions (0.34 [CI, 0.32 to 0.35] vs. 0.39 [CI, 0.37 to 0.41] per question). A strong single dimension showed that the examination measured the same factor with or without the resource. Only 1 electronic resource was evaluated. Inclusion of an electronic resource with time constraints did not adversely affect test performance and did not change

  18. [Controlled randomized clinical trials].

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    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  19. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards

    Directory of Open Access Journals (Sweden)

    Grimshaw Jeremy M

    2010-02-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues require efficient electronic search strategies (filters or hedges to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a evaluate sensitivity ("recall" and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type with respect to identifying CRTs, (b evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. Methods We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. Results The existing strategy (randomized controlled trial.pt is sensitive (93.8% for identifying CRTs, but has relatively low precision (9%, number needed to read 11; the number needed to read can be halved to 5 (precision 18.4% by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4% but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The

  20. Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards.

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    Taljaard, Monica; McGowan, Jessie; Grimshaw, Jeremy M; Brehaut, Jamie C; McRae, Andrew; Eccles, Martin P; Donner, Allan

    2010-02-16

    Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ("recall") and precision of a well-known electronic search strategy ("randomized controlled trial" as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time. We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews. The existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has

  1. InsuOnline, an Electronic Game for Medical Education on Insulin Therapy: A Randomized Controlled Trial With Primary Care Physicians.

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    Diehl, Leandro Arthur; Souza, Rodrigo Martins; Gordan, Pedro Alejandro; Esteves, Roberto Zonato; Coelho, Izabel Cristina Meister

    2017-03-09

    Most patients with diabetes mellitus (DM) are followed by primary care physicians, who often lack knowledge or confidence to prescribe insulin properly. This contributes to clinical inertia and poor glycemic control. Effectiveness of traditional continuing medical education (CME) to solve that is limited, so new approaches are required. Electronic games are a good option, as they can be very effective and easily disseminated. The objective of our study was to assess applicability, user acceptance, and educational effectiveness of InsuOnline, an electronic serious game for medical education on insulin therapy for DM, compared with a traditional CME activity. Primary care physicians (PCPs) from South of Brazil were invited by phone or email to participate in an unblinded randomized controlled trial and randomly allocated to play the game InsuOnline, installed as an app in their own computers, at the time of their choice, with minimal or no external guidance, or to participate in a traditional CME session, composed by onsite lectures and cases discussion. Both interventions had the same content and duration (~4 h). Applicability was assessed by the number of subjects who completed the assigned intervention in each group. Insulin-prescribing competence (factual knowledge, problem-solving skills, and attitudes) was self-assessed through a questionnaire applied before, immediately after, and 3 months after the interventions. Acceptance of the intervention (satisfaction and perceived importance for clinical practice) was also assessed immediately after and 3 months after the interventions, respectively. Subjects' characteristics were similar between groups (mean age 38, 51.4% [69/134] male). In the game group, 69 of 88 (78%) completed the intervention, compared with 65 of 73 (89%) in the control group, with no difference in applicability. Percentage of right answers in the competence subscale, which was 52% at the baseline in both groups, significantly improved

  2. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  3. Effects of Home Access to Active Videogames on Child Self-Esteem, Enjoyment of Physical Activity, and Anxiety Related to Electronic Games: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    Abbott, Rebecca A; Smith, Anne J; Howie, Erin K; Pollock, Clare; Straker, Leon

    2014-08-01

    Active-input videogames could provide a useful conduit for increasing physical activity by improving a child's self-confidence, physical activity enjoyment, and reducing anxiety. Therefore this study evaluated the impact of (a) the removal of home access to traditional electronic games or (b) their replacement with active-input videogames, on child self-perception, enjoyment of physical activity, and electronic game use anxiety. This was a crossover, randomized controlled trial, conducted over a 6-month period in participants' family homes in metropolitan Perth, Australia, from 2007 to 2010. Children 10-12 years old were recruited through school and community media. Of 210 children who were eligible, 74 met inclusion criteria, and 8 withdrew, leaving 66 children (33 girls) for analysis. A counterbalanced randomized order of three conditions sustained for 8 weeks each: No home access to electronic games, home access to traditional electronic games, and home access to active-input electronic games. Perception of self-esteem (Harter's Self Perception Profile for Children), enjoyment of physical activity (Physical Activity Enjoyment Scale questionnaire), and anxiety toward electronic game use (modified Loyd and Gressard Computer Anxiety Subscale) were assessed. Compared with home access to traditional electronic games, neither removal of all electronic games nor replacement with active-input games resulted in any significant change to child self-esteem, enjoyment of physical activity, or anxiety related to electronic games. Although active-input videogames have been shown to be enjoyable in the short term, their ability to impact on psychological outcomes is yet to be established.

  4. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  5. Intensive nursing care by an electronic followup system to promote secondary prevention after percutaneous coronary intervention: a randomized trial.

    Science.gov (United States)

    Hu, Xin; Zhu, Xiuqin; Gao, Lei

    2014-01-01

    To investigate the effectiveness of an intensive nursing care electronic followup system for cardiovascular risk management after percutaneous coronary intervention (PCI). In total, 840 subjects who underwent PCI in a single hospital in Beijing between January 2010 and January 2012 were enrolled. All subjects were randomized into the control and intensive nursing care groups (n = 420 each group). Both groups received standard secondary prevention according to guidelines. The control group received regular followup while the intensive nursing care group was closely monitored and followed by specific nursing staff with the electronic followup system. In total, 807 subjects were followed up for 1 year. Compared with subjects in the control group, those in the intensive group had decreased levels of total cholesterol (3.99 ± 1.08 vs 3.76 ± 0.98; P Intensive nursing care by the electronic followup system may lead to an improvement in quality of secondary prevention after PCI, including risk factor control, the use of medication, and self-management abilities.

  6. A randomized trial comparing in person and electronic interventions for improving adherence to oral medications in schizophrenia.

    Science.gov (United States)

    Velligan, Dawn; Mintz, Jim; Maples, Natalie; Xueying, Li; Gajewski, Stephanie; Carr, Heather; Sierra, Cynthia

    2013-09-01

    Poor adherence to medication leads to symptom exacerbation and interferes with the recovery process for patients with schizophrenia. Following baseline assessment, 142 patients in medication maintenance at a community mental health center were randomized to one of 3 treatments for 9 months: (1) PharmCAT, supports including pill containers, signs, alarms, checklists and the organization of belongings established in weekly home visits from a PharmCAT therapist; (2) Med-eMonitor (MM), an electronic medication monitor that prompts use of medication, cues the taking of medication, warns patients when they are taking the wrong medication or taking it at the wrong time, record complaints, and, through modem hookup, alerts treatment staff of failures to take medication as prescribed; (3) Treatment as Usual (TAU). All patients received the Med-eMonitor device to record medication adherence. The device was programmed for intervention only in the MM group. Data on symptoms, global functioning, and contact with emergency services and police were obtained every 3 months. Repeated measures analyses of variance for mixed models indicated that adherence to medication was significantly better in both active conditions than in TAU (both p<0.0001). Adherence in active treatments ranged from 90-92% compared to 73% in TAU based on electronic monitoring. In-person and electronic interventions significantly improved adherence to medication, but that did not translate to improved clinical outcomes. Implications for treatment and health care costs are discussed.

  7. Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

    Directory of Open Access Journals (Sweden)

    Danielle M. Nash

    2017-04-01

    Full Text Available Background: Many patients with or at risk for chronic kidney disease (CKD in the primary care setting are not receiving recommended care. Objective: The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. Design: A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. Setting: The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. Intervention: The intervention group will receive resources from the “CKD toolkit” to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. Measurements: Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of

  8. a randomized controlled trial.

    African Journals Online (AJOL)

    milk, only an estimated one -fourth of neonates in India were breastfed within ... standard of care in India and mothers are informed about. 6 months of ... weeks postpartum. A random number sequence was generated using a com- puter program. Block randomization was used with a fixed block size of four. Concealment of ...

  9. Randomized trial of automated, electronic monitoring to facilitate early detection of sepsis in the intensive care unit*.

    Science.gov (United States)

    Hooper, Michael H; Weavind, Lisa; Wheeler, Arthur P; Martin, Jason B; Gowda, Supriya Srinivasa; Semler, Matthew W; Hayes, Rachel M; Albert, Daniel W; Deane, Norment B; Nian, Hui; Mathe, Janos L; Nadas, Andras; Sztipanovits, Janos; Miller, Anne; Bernard, Gordon R; Rice, Todd W

    2012-07-01

    To determine whether automated identification with physician notification of the systemic inflammatory response syndrome in medical intensive care unit patients expedites early administration of new antibiotics or improvement of other patient outcomes in patients with sepsis. : A prospective randomized, controlled, single center study. Medical intensive care unit of an academic, tertiary care medical center. Four hundred forty-two consecutive patients admitted over a 4-month period who met modified systemic inflammatory response syndrome criteria in a medical intensive care unit. Patients were randomized to monitoring by an electronic "Listening Application" to detect modified (systemic inflammatory response syndrome) criteria vs. usual care. The listening application notified physicians in real time when modified systemic inflammatory response syndrome criteria were detected, but did not provide management recommendations. The median time to new antibiotics was similar between the intervention and usual care groups when comparing among all patients (6.0 hr vs. 6.1 hr, p = .95), patients with sepsis (5.3 hr vs. 5.1 hr; p = .90), patients on antibiotics at enrollment (5.2 hr vs. 7.0 hr, p = .27), or patients not on antibiotics at enrollment (5.2 hr vs. 5.1 hr, p = .85). The amount of fluid administered following detection of modified systemic inflammatory response syndrome criteria was similar between groups whether comparing all patients or only patients who were hypotensive at enrollment. Other clinical outcomes including intensive care unit length of stay, hospital length of stay, and mortality were not shown to be different between patients in the intervention and control groups. Realtime alerts of modified systemic inflammatory response syndrome criteria to physicians in one tertiary care medical intensive care unit were feasible and safe but did not influence measured therapeutic interventions for sepsis or significantly alter clinical outcomes.

  10. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Meriwether Rebecca A

    2011-05-01

    Full Text Available Abstract Background The SenseWear™ Armband (SWA (BodyMedia, Inc. Pittsburgh, PA is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes. Methods We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI, 33.3 ± 5.2 kg/m2; 81% women, 32% African-American from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50, a group-based behavioral weight loss program (GWL, n = 49, the armband alone (SWA-alone, n = 49, or the GWL plus the armband (GWL+SWA, n = 49, during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave. Results Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention. There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss. Trial Registration ClinicalTrials.gov: NCT00957008

  11. The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool

    Directory of Open Access Journals (Sweden)

    Okoniewska Barbara M

    2012-11-01

    Full Text Available Abstract Background The transition between acute care and community care represents a vulnerable period in health care delivery. The vulnerability of this period has been attributed to changes to patients’ medication regimens during hospitalization, failure to reconcile discrepancies between admission and discharge and the burdening of patients/families to take over care responsibilities at discharge and to relay important information to the primary care physician. Electronic communication platforms can provide an immediate link between acute care and community care physicians (and other community providers, designed to ensure consistent information transfer. This study examines whether a transfer-of-care (TOC communication tool is efficacious and cost-effective for reducing hospital readmission, adverse events and adverse drug events as well as reducing death. Methods A randomized controlled trial conducted on the Medical Teaching Unit of a Canadian tertiary care centre will evaluate the efficacy and cost-effectiveness of a TOC communication tool. Medical in-patients admitted to the unit will be considered for this study. Data will be collected upon admission, and a total of 1400 patients will be randomized. The control group’s acute care stay will be summarized using a traditional dictated summary, while the intervention group will have a summary generated using the TOC communication tool. The primary outcome will be a composite, at 3 months, of death or readmission to any Alberta acute-care hospital. Secondary outcomes will be the occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge. Patients with adverse outcomes will have their cases reviewed by two Royal College certified internists or College-certified family physicians, blinded to patients’ group assignments, to determine the type, severity, preventability and ameliorability of all detected adverse outcomes. An accompanying economic

  12. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  13. Intravaginal stimulation randomized trial.

    Science.gov (United States)

    Smith, J J

    1996-01-01

    The effectiveness of intravaginal electrical stimulation was compared to standard therapy in the treatment of genuine stress urinary incontinence and detrusor instability. A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment. Of the women 18 with stress urinary incontinence were randomized to electrical stimulation or Kegel exercise and 38 with detrusor instability were randomized to anticholinergic therapy or electrical stimulation. Of patients using electrical stimulation in the stress urinary incontinence group 66% improved and 72% of the patients with detrusor instability treated with electrical stimulation improved. These rates were not statistically significant when compared to traditional therapy. Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability.

  14. Mobile access to virtual randomization for investigator-initiated trials.

    Science.gov (United States)

    Deserno, Thomas M; Keszei, András P

    2017-08-01

    Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

  15. Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones--the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial.

    Science.gov (United States)

    Faurholt-Jepsen, Maria; Vinberg, Maj; Frost, Mads; Christensen, Ellen Margrethe; Bardram, Jakob; Kessing, Lars Vedel

    2014-11-25

    Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed. Recently, the MONARCA I randomized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms. The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purposes, but had fewer manic symptoms during the trial. It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage, social activity, physical activity, and mobility. The Monsenso system, for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial. The MONARCA II trial uses a randomized controlled single-blind parallel-group design. Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder, Denmark are included and randomized to either daily use of the Monsenso system including an feedback loop between patients and clinicians (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for a 9-month trial period. The trial was started in September 2014 and recruitment is ongoing. The outcomes are: differences in depressive and manic symptoms; rate of depressive and manic episodes (primary); automatically generated objective data on measures of illness activity; number of days hospitalized; psychosocial functioning (secondary); perceived stress; quality of life; self-rated depressive symptoms; self-rated manic symptoms; recovery; empowerment and adherence to medication (tertiary) between the intervention group and the

  16. Electronic Monitoring-Based Counseling to Enhance Adherence Among HIV-Infected Patients: A Randomized Controlled Trial

    NARCIS (Netherlands)

    de Bruin, Marijn; Hospers, Harm J.; van Breukelen, Gerard J. P.; Kok, Gerjo; Koevoets, William M.; Prins, Jan M.

    2010-01-01

    Objective: To investigated the effectiveness of an adherence intervention (AIMS) designed to fit HIV-clinics' routine care procedures. Design: Through block randomization, patients were allocated to the intervention or control group. The study included 2 months baseline measurement, 3 months

  17. A Randomized Controlled Trial of Real-Time Electronic Adherence Monitoring With Text Message Dosing Reminders in People Starting First-Line Antiretroviral Therapy.

    Science.gov (United States)

    Orrell, Catherine; Cohen, Karen; Mauff, Katya; Bangsberg, David R; Maartens, Gary; Wood, Robin

    2015-12-15

    There are conflicting findings about whether mobile phone text message reminders impact on antiretroviral adherence. We hypothesized that text reminders sent when dosing was late would improve adherence and HIV viral suppression. Antiretroviral therapy (ART)-naive participants, from a South African outpatient ART clinic, were randomized to standard of care (SoC, 3 pretreatment education sessions), or intervention (SoC and automated text reminders if dosing >30 minutes late). Dosing time was recorded by real-time electronic adherence monitoring devices, given to participants at ART start. CD4 cell count and HIV RNA were determined at baseline, 16 and 48 weeks. Primary outcome was cumulative adherence execution by electronic adherence monitoring device. HIV-1 viral suppression (TIs) >72 hours were secondary outcomes. Analysis was by intention to treat (missing = failure). Registration was with the Pan-African Clinical Trials Registry: PACTR201311000641402. A total of 230 participants were randomly assigned to control (n = 115) or intervention (n = 115) arms. Median adherence was 82.1% (interquartile range, 56.6%-94.6%) in the intervention arm, compared with 80.4% (interquartile range, 52.8%-93.8%) for SoC [adjusted odds ratio for adherence 1.08; 95% confidence interval (CI): 0.77 to 1.52]. Suppressed HIV RNA (TIs of >72 hours was reduced (adjusted incident rate ratio, 0.84; 95% CI: 0.75 to 0.94). Text message reminders linked to late doses detected by real-time adherence monitoring reduced the number of prolonged TIs, but did not significantly improve adherence or viral suppression.

  18. The impact of self-interviews on response patterns for sensitive topics: a randomized trial of electronic delivery methods for a sexual behaviour questionnaire in rural South Africa

    Directory of Open Access Journals (Sweden)

    Guy Harling

    2017-08-01

    Full Text Available Abstract Background Self-interviews, where the respondent rather than the interviewer enters answers to questions, have been proposed as a way to reduce social desirability bias associated with interviewer-led interviews. Computer-assisted self-interviews (CASI are commonly proposed since the computer programme can guide respondents; however they require both language and computer literacy. We evaluated the feasibility and acceptability of using electronic methods to administer quantitative sexual behaviour questionnaires in the Somkhele demographic surveillance area (DSA in rural KwaZulu-Natal, South Africa. Methods We conducted a four-arm randomized trial of paper-and-pen-interview, computer-assisted personal-interview (CAPI, CASI and audio-CASI with an age-sex-urbanicity stratified sample of 504 adults resident in the DSA in 2015. We compared respondents’ answers to their responses to the same questions in previous surveillance rounds. We also conducted 48 cognitive interviews, dual-coding responses using the Framework approach. Results Three hundred forty (67% individuals were interviewed and covariates and participation rates were balanced across arms. CASI and audio-CASI were significantly slower than interviewer-led interviews. Item non-response rates were higher in self-interview arms. In single-paper meta-analysis, self-interviewed individuals reported more socially undesirable sexual behaviours. Cognitive interviews found high acceptance of both self-interviews and the use of electronic methods, with some concerns that self-interview methods required more participant effort and literacy. Conclusions Electronic data collection methods, including self-interview methods, proved feasible and acceptable for completing quantitative sexual behaviour questionnaires in a poor, rural South African setting. However, each method had both benefits and costs, and the choice of method should be based on context-specific criteria.

  19. Electrocardiogram ST Analysis During Labor : A Systematic Review and Meta-analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Saccone, Gabriele; Schuit, Ewoud; Amer-Wåhlin, Isis; Xodo, Serena; Berghella, Vincenzo

    OBJECTIVE: To compare the effectiveness of cardiotocography plus ST analysis with cardiotocography alone during labor. DATA SOURCES: Randomized controlled trials were identified by searching electronic databases. METHODS OF STUDY SELECTION: We included all randomized controlled trials comparing

  20. Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

    Directory of Open Access Journals (Sweden)

    Wisnivesky Juan

    2011-09-01

    Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

  1. Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 1: state of the art.

    Science.gov (United States)

    Johansen, Monika Alise; Henriksen, Eva; Horsch, Alexander; Schuster, Tibor; Berntsen, Gro K Rosvold

    2012-10-03

    Over the last two decades, the number of studies on electronic symptom reporting has increased greatly. However, the field is very heterogeneous: the choices of patient groups, health service innovations, and research targets seem to involve a broad range of foci. To move the field forward, it is necessary to build on work that has been done and direct further research to the areas holding most promise. Therefore, we conducted a comprehensive review of randomized controlled trials (RCTs) focusing on electronic communication between patient and provider to improve health care service quality, presented in two parts. Part 2 investigates the methodological quality and effects of the RCTs, and demonstrates some promising benefits of electronic symptom reporting. To give a comprehensive overview of the most mature part of this emerging field regarding (1) patient groups, (2) health service innovations, and (3) research targets relevant to electronic symptom reporting. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles published from 1990 to November 2011. Inclusion criteria were RCTs of interventions where patients or parents reported health information electronically to the health care system for health care purposes and were given feedback. Of 642 records identified, we included 32 articles representing 29 studies. The included articles were published from 2002, with 24 published during the last 5 years. The following five patient groups were represented: respiratory and lung diseases (12 studies), cancer (6), psychiatry (6), cardiovascular (3), and diabetes (1). In addition to these, 1 study had a mix of three groups. All included studies, except 1, focused on long-term conditions. We identified four categories of health service innovations: consultation support (7 studies), monitoring with clinician support (12), self-management with clinician support (9

  2. Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial.

    Science.gov (United States)

    Sedrak, Mina S; Myers, Jennifer S; Small, Dylan S; Nachamkin, Irving; Ziemba, Justin B; Murray, Dana; Kurtzman, Gregory W; Zhu, Jingsan; Wang, Wenli; Mincarelli, Deborah; Danoski, Daniel; Wells, Brian P; Berns, Jeffrey S; Brennan, Patrick J; Hanson, C William; Dine, C Jessica; Patel, Mitesh S

    2017-07-01

    Many health systems are considering increasing price transparency at the time of order entry. However, evidence of its impact on clinician ordering behavior is inconsistent and limited to single-site evaluations of shorter duration. To test the effect of displaying Medicare allowable fees for inpatient laboratory tests on clinician ordering behavior over 1 year. The Pragmatic Randomized Introduction of Cost data through the electronic health record (PRICE) trial was a randomized clinical trial comparing a 1-year intervention to a 1-year preintervention period, and adjusting for time trends and patient characteristics. The trial took place at 3 hospitals in Philadelphia between April 2014 and April 2016 and included 98 529 patients comprising 142 921 hospital admissions. Inpatient laboratory test groups were randomly assigned to display Medicare allowable fees (30 in intervention) or not (30 in control) in the electronic health record. Primary outcome was the number of tests ordered per patient-day. Secondary outcomes were tests performed per patient-day and Medicare associated fees. The sample included 142 921 hospital admissions representing patients who were 51.9% white (74 165), 38.9% black (55 526), and 56.9% female (81 291) with a mean (SD) age of 54.7 (19.0) years. Preintervention trends of order rates among the intervention and control groups were similar. In adjusted analyses of the intervention group compared with the control group over time, there were no significant changes in overall test ordering behavior (0.05 tests ordered per patient-day; 95% CI, -0.002 to 0.09; P = .06) or associated fees ($0.24 per patient-day; 95% CI, -$0.42 to $0.91; P = .47). Exploratory subset analyses found small but significant differences in tests ordered per patient-day based on patient intensive care unit (ICU) stay (patients with ICU stay: -0.16; 95% CI, -0.31 to -0.01; P = .04; patients without ICU stay: 0.13; 95% CI, 0.08-0.17; P < .001) and the

  3. Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-09-01

    To report the results of a randomized controlled trial using an electronic monitoring device (EM) plus a motivational interviewing (MI) intervention to enhance adherence to disease-modifying therapies (DMT) in pediatric MS. Fifty-two youth with MS (16.03 ± 2.2 years) were randomized to receive either MI (n = 25) (target intervention) or a MS medication video (n = 27) (attention control). Primary endpoint was change in adherence. Secondary outcomes included changes in quality of life, well-being and self-efficacy. Random effects modeling and Cohen's effect size computation evaluated intervention impact. Longitudinal random effect models revealed that the MI group decreased their EM adherence (GroupxTime interaction = -0.19), while increasing frequency of parental DMT reminder (26.01)/administration (11.69). We found decreased EM use in the MI group at 6 months (Cohen's d = -0.61), but increased pharmacy refill adherence (d = 0.23). Parental reminders about medication increased in MI subjects vs controls (d = 0.59 at 3 months; d = 0.70 at 6 months). We found increases in self-reported adherence (d = 0.21) at 3 but not 6 months, fewer barriers to adherence at three (d = -0.58) and six months (d = -0.31), better physical (d = 0.23 at 3 months; d = 0.45 at 6 months), emotional (d = 0.25 at 3 months) and self-efficacy function (d = 0.55 at 3 months; 0.48 at 6 months), but worse well-being, including self-acceptance (d = -0.53 at 6 months) and environmental mastery (d = -0.42 at 3 and 6 months) in intervention as compared to control patients. Participants receiving MI + EM experienced worsening on objective measures of adherence and increased parental involvement, but improved on some self- and parent-reported measures. MI participants reported improvements in quality of life and self-efficacy, but worsened well-being.

  4. Electronic feedback in a diet- and physical activity-based lifestyle intervention for weight loss: a randomized controlled trial.

    Science.gov (United States)

    Shuger, Sara L; Barry, Vaughn W; Sui, Xuemei; McClain, Amanda; Hand, Gregory A; Wilcox, Sara; Meriwether, Rebecca A; Hardin, James W; Blair, Steven N

    2011-05-18

    The SenseWear™ Armband (SWA) (BodyMedia, Inc. Pittsburgh, PA) is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes. We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI), 33.3 ± 5.2 kg/m(2); 81% women, 32% African-American) from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50), a group-based behavioral weight loss program (GWL, n = 49), the armband alone (SWA-alone, n = 49), or the GWL plus the armband (GWL+SWA, n = 49), during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave. Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention). There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P < 0.0001) but not in the Standard Care group (0.89 kg, P = 0.39) at month 9. Only the GWL+SWA group achieved significant weight loss at month 9 compared to the Standard Care group (P = 0.04). Significant waist circumference reductions were achieved in all 4 groups at month 9 (Standard Care, 3.49 cm, P = 0.0004; GWL, 2.42 cm, P = 0.008; SWA-alone, 3.59 cm, P < 0.0001; GWL+SWA, 6.77 cm, P < 0.0001), but no intervention group had significantly reduced waist circumference compared to the Standard Care group. Continuous

  5. Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

    Science.gov (United States)

    Johansen, Monika Alise; Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

    2012-10-03

    We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12

  6. Randomized Clinical Trials in Stroke Research

    OpenAIRE

    Ahn, Chul; Ahn, Daniel

    2010-01-01

    A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.

  7. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  8. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  9. Evaluating a Web-Based Coaching Program Using Electronic Health Records for Patients With Chronic Obstructive Pulmonary Disease in China: Randomized Controlled Trial.

    Science.gov (United States)

    Wang, Lan; He, Lin; Tao, Yanxia; Sun, Li; Zheng, Hong; Zheng, Yashu; Shen, Yuehao; Liu, Suyan; Zhao, Yue; Wang, Yaogang

    2017-07-21

    Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death in the world, and it continues to increase in developing countries. The World Health Organization expects COPD to be the third most common cause of death in the world by 2020. Effective and continuous postdischarge care can help patients to maintain good health. The use of electronic health records (EHRs) as an element of community health care is new technology in China. The aim of this study was to develop and evaluate a Web-based coaching program using EHRs for physical function and health-related quality of life for patients with COPD in China. A randomized controlled trial was conducted from 2008 to 2015 at two hospitals. The control group received routine care and the intervention group received routine care with the addition of the Web-based coaching program using EHRs. These were used to manage patients' demographic and clinical variables, publish relevant information, and have communication between patients and health care providers. Participants were not blinded to group assignment. The effects of the intervention were evaluated by lung function, including percent of forced expiratory volume in 1 second (FEV1%), percent of forced vital capacity (FVC%), peak expiratory flow (PEF), maximum midexpiratory flow; St George's Respiratory Questionnaire (SGRQ); Modified Medical Research Council Dyspnea Scale (MMRC); and 6-Minute Walk Test (6MWT). Data were collected before the program, and at 1, 3, 6, and 12 months after the program. Of the 130 participants, 120 (92.3%) completed the 12-month follow-up program. There were statistically significant differences in lung function (FEV1%: F1,4=5.47, P=.002; FVC%: F1,4=3.06, P=.02; PEF: F1,4=12.49, Pprogram using EHRs in China appears to be useful for patients with COPD when they are discharged from hospital into the community. It promotes the sharing of patients' medical information by hospital and community nurses, and achieves

  10. Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial.

    Science.gov (United States)

    Lechtzin, N; West, N; Allgood, S; Wilhelm, E; Khan, U; Mayer-Hamblett, N; Aitken, M L; Ramsey, B W; Boyle, M P; Mogayzel, P J; Goss, C H

    2013-11-01

    Acute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis (CF). Pulmonary exacerbations lead to impaired lung function, worse quality of life, and shorter survival. We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes. Describe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations. A randomized, non-blinded, multi-center trial in 320 individuals with CF aged 14 years and older. The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation. Participants will be enrolled in the study for 12 months. The primary endpoint is change in FEV1 (L) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV1 measurements. Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation, number of acute pulmonary exacerbations, number of hospitalization days for acute pulmonary exacerbation, time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation, change in health related quality of life, change in treatment burden, change in CF respiratory symptoms, and adherence to the study protocol. This study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations. We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline, reduce respiratory symptoms and improve the quality of life for individuals with CF. © 2013.

  11. Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial.

    Science.gov (United States)

    Volpp, Kevin G; Troxel, Andrea B; Mehta, Shivan J; Norton, Laurie; Zhu, Jingsan; Lim, Raymond; Wang, Wenli; Marcus, Noora; Terwiesch, Christian; Caldarella, Kristen; Levin, Tova; Relish, Mike; Negin, Nathan; Smith-McLallen, Aaron; Snyder, Richard; Spettell, Claire M; Drachman, Brian; Kolansky, Daniel; Asch, David A

    2017-08-01

    Adherence to medications prescribed after acute myocardial infarction (AMI) is low. Wireless technology and behavioral economic approaches have shown promise in improving health behaviors. To determine whether a system of medication reminders using financial incentives and social support delays subsequent vascular events in patients following AMI compared with usual care. Two-arm, randomized clinical trial with a 12-month intervention conducted from 2013 through 2016. Investigators were blinded to study group, but participants were not. Design was a health plan-intermediated intervention for members of several health plans. We recruited 1509 participants from 7179 contacted AMI survivors (insured with 5 large US insurers nationally or with Medicare fee-for-service at the University of Pennsylvania Health System). Patients aged 18 to 80 years were eligible if currently prescribed at least 2 of 4 study medications (statin, aspirin, β-blocker, antiplatelet agent), and were hospital inpatients for 1 to 180 days and discharged home with a principal diagnosis of AMI. Patients were randomized 2:1 to an intervention using electronic pill bottles combined with lottery incentives and social support for medication adherence (1003 patients), or to usual care (506 patients). Primary outcome was time to first vascular rehospitalization or death. Secondary outcomes were time to first all-cause rehospitalization, total number of repeated hospitalizations, medication adherence, and total medical costs. A total of 35.5% of participants were female (n = 536); mean (SD) age was 61.0 (10.3) years. There were no statistically significant differences between study arms in time to first rehospitalization for a vascular event or death (hazard ratio, 1.04; 95% CI, 0.71 to 1.52; P = .84), time to first all-cause rehospitalization (hazard ratio, 0.89; 95% CI, 0.73 to 1.09; P = .27), or total number of repeated hospitalizations (hazard ratio, 0.94; 95% CI, 0.60 to 1.48; P

  12. Impact of Laboratory Charge Display Within the Electronic Health Record Across an Entire Academic Medical Center: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Schmidt, Robert L; Colbert-Getz, Jorie M; Milne, Caroline K; Vargo, Daniel J; Hussong, Jerry W; Hoidal, John R; Markewitz, Boaz A; Walker, Brandon S; Kawamoto, Kensaku

    2017-11-20

    To determine the impact of systemwide charge display on laboratory utilization. This was a randomized controlled trial with a baseline period and an intervention period. Tests were randomized to a control arm or an active arm. The maximum allowable Medicare reimbursement rate was displayed for tests in the active arm during the intervention period. Total volume of tests in the active arm was compared with those in the control arm. Residents were surveyed before and after the intervention to assess charge awareness. Charge display had no effect on order behavior. This result held for patient type (inpatient vs outpatient) and for insurance category (commercial, government, self-pay). Residents overestimated the charges of tests both before and after the intervention. Many residents failed to notice the charge display in the computerized order entry system. The impact of charge display depends on context. Charge display is not always effective.

  13. Effect of pay-for-performance incentives on quality of care in small practices with electronic health records: a randomized trial.

    Science.gov (United States)

    Bardach, Naomi S; Wang, Jason J; De Leon, Samantha F; Shih, Sarah C; Boscardin, W John; Goldman, L Elizabeth; Dudley, R Adams

    2013-09-11

    Most evaluations of pay-for-performance (P4P) incentives have focused on large-group practices. Thus, the effect of P4P in small practices, where many US residents receive care, is largely unknown. Furthermore, whether electronic health records (EHRs) with chronic disease management capabilities support small-practice response to P4P has not been studied. To assess the effect of P4P incentives on quality in EHR-enabled small practices in the context of an established quality improvement initiative. A cluster-randomized trial of small (<10 clinicians) primary care clinics in New York City from April 2009 through March 2010. A city program provided all participating clinics with the same EHR software with decision support and patient registry functionalities and quality improvement specialists offering technical assistance. Incentivized clinics were paid for each patient whose care met the performance criteria, but they received higher payments for patients with comorbidities, who had Medicaid insurance, or who were uninsured (maximum payments: $200/patient; $100,000/clinic). Quality reports were given quarterly to both the intervention and control groups. Comparison of differences in performance improvement, from the beginning to the end of the study, between control and intervention clinics for aspirin or antithrombotic prescription, blood pressure control, cholesterol control, and smoking cessation interventions. Mixed-effects logistic regression was used to account for clustering of patients within clinics, with a treatment by time interaction term assessing the statistical significance of the effect of the intervention. Participating clinics (n = 42 for each group) had similar baseline characteristics, with a mean of 4592 (median, 2500) patients at the intervention group clinics and 3042 (median, 2000) at the control group clinics. Intervention clinics had greater adjusted absolute improvement in rates of appropriate antithrombotic prescription (12.0% vs 6

  14. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  15. Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME study

    Directory of Open Access Journals (Sweden)

    Rodgers Anthony

    2009-05-01

    Full Text Available Abstract Background Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI, percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Methods/Design Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention. Discussion An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000632493

  16. Electronic monitoring of symptoms and syndromes associated with cancer: methods of a randomized controlled trial SAKK 95/06 E-MOSAIC

    Directory of Open Access Journals (Sweden)

    Blum David

    2012-09-01

    Full Text Available Abstract Background In patients with advanced, incurable cancer, anticancer treatment may be used to alleviate cancer-related symptoms, but monitoring of them in daily practice is rarely done. We aim to test the effectiveness of a real-time symptom and syndrome assessment using the E-MOSAIC software installed in handheld computer generating a longitudinal monitoring sheet (LoMoS provided to the oncologists in a phase III setting. Methods In this prospective multicentre cluster randomized phase-III trial patients with any incurable solid tumor and having defined cancer related symptoms, who receive new outpatient chemotherapy in palliative intention (expected tumor-size response rate ≤20% are eligible. Immediately before the weekly visit to oncologists, all patients complete with nurse assistance the E-MOSAIC Assessment: Edmonton Symptom Assessment Scale, ≤3 additional symptoms, estimated nutritional intake, body weight, Karnofsky and medications for pain and cachexia. Experienced oncologists will be randomized to receive the LoMoS or not. To minimize contamination, LoMoS are removed from the medical charts after visits. Primary endpoint is the difference in global quality of life (items 29 & 30 of EORTC-QlQ-C30 between baseline and last study visit at week 6, with a 10 point between-arm difference considered to be clinically relevant. 20 clusters (=oncologists per treatment arm with 4–8 patients each are aimed for to achieve a significance level of 5% and a power of 80% in a mixed model approach. Selected co- variables are included in the model for adjustment. Secondary endpoints include patient-perceived patient-physician communication symptom burden over time, and oncologists’ symptom management performance (predefined thresholds of symptoms compared to oncologists’ pharmacological, diagnostic or counselling actions [structured chart review]. Discussion This trial will contribute to the research question, whether structured

  17. Dynamic randomization and a randomization model for clinical trials data.

    Science.gov (United States)

    Kaiser, Lee D

    2012-12-20

    Randomization models are useful in supporting the validity of linear model analyses applied to data from a clinical trial that employed randomization via permuted blocks. Here, a randomization model for clinical trials data with arbitrary randomization methodology is developed, with treatment effect estimators and standard error estimators valid from a randomization perspective. A central limit theorem for the treatment effect estimator is also derived. As with permuted-blocks randomization, a typical linear model analysis provides results similar to the randomization model results when, roughly, unit effects display no pattern over time. A key requirement for the randomization inference is that the unconditional probability that any patient receives active treatment is constant across patients; when this probability condition is violated, the treatment effect estimator is biased from a randomization perspective. Most randomization methods for balanced, 1 to 1, treatment allocation satisfy this condition. However, many dynamic randomization methods for planned unbalanced treatment allocation, like 2 to 1, do not satisfy this constant probability condition, and these methods should be avoided. Copyright © 2012 John Wiley & Sons, Ltd.

  18. Randomized Controlled Trial of Electronic Care Plan Alerts and Resource Utilization by High Frequency Emergency Department Users with Opioid Use Disorder

    Directory of Open Access Journals (Sweden)

    Niels Rathlev, MD

    2016-01-01

    Full Text Available Introduction: There is a paucity of literature supporting the use of electronic alerts for patients with high frequency emergency department (ED use. We sought to measure changes in opioid prescribing and administration practices, total charges and other resource utilization using electronic alerts to notify providers of an opioid-use care plan for high frequency ED patients. Methods: This was a randomized, non-blinded, two-group parallel design study of patients who had 1 opioid use disorder and 2 high frequency ED use. Three affiliated hospitals with identical electronic health records participated. Patients were randomized into “Care Plan” versus “Usual Care groups”. Between the years before and after randomization, we compared as primary outcomes the following: 1 opioids (morphine mg equivalents prescribed to patients upon discharge and administered to ED and inpatients; 2 total medical charges, and the numbers of; 3 ED visits, 4 ED visits with advanced radiologic imaging (computed tomography [CT] or magnetic resonance imaging [MRI] studies, and 5 inpatient admissions. Results: A total of 40 patients were enrolled. For ED and inpatients in the “Usual Care” group, the proportion of morphine mg equivalents received in the post-period compared with the pre-period was 15.7%, while in the “Care Plan” group the proportion received in the post-period compared with the pre-period was 4.5% (ratio=0.29, 95% CI [0.07-1.12]; p=0.07. For discharged patients in the “Usual Care” group, the proportion of morphine mg equivalents prescribed in the post-period compared with the pre-period was 25.7% while in the “Care Plan” group, the proportion prescribed in the post-period compared to the pre-period was 2.9%. The “Care Plan” group showed an 89% greater proportional change over the periods compared with the “Usual Care” group (ratio=0.11, 95% CI [0.01-0.092]; p=0.04. Care plans did not change the total charges, or, the numbers

  19. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  20. Electron and high-dose-rate brachytherapy boost in the conservative treatment of stage I-II breast cancer. First results of the randomized Budapest boost trial

    Energy Technology Data Exchange (ETDEWEB)

    Polgar, C.; Fodor, J. [National Institute of Oncology, Department of Radiotherapy, Budapest (Hungary); Orosz, Z. [National Institute of Oncology, Center of Experimental and Human Tumor Pathology Budapest (HU)] [and others

    2002-11-01

    Background and Aims: To evaluate the effect of electron and high-dose-rate brachytherapy (HDR BT) boost on local tumor control (LTC), side effects and cosmesis after breast-conserving surgery (BCS) in a prospective randomized study. Patients and Methods: 207 women with stage I-II breast cancer who underwent BCS were treated by 50 Gy irradiation to the whole breast and then randomly assigned to receive either a boost to the tumor bed (n=104) or no further radiotherapy (n=103). Boost treatments consisted of either 16 Gy electron irradiation (n=52) or 12-14.25 Gy HDR BT (n=52). Breast cancer-related events, side effects, and cosmetic results were assessed. Results: At a median follow-up of 5.3 years, the crude rate of local recurrence was 6.7% (7/104) with and 15.5% (16/103) without boost. The 5-year probability of LTC, relapse-free survival (RFS), and cancer-specific survival (CSS) was 92.7% vs 84.9% (p=0.049), 76.6% vs 66.2% (p=0.044), and 90.4% vs. 82.1% (p=0.053), respectively. There was no significant difference in LTC between patients treated with electron or HDR BT boost (94.2% vs 91.4%; p=0.74). On multivariate analysis, patient age <40 years (RR: 4.53), positive margin status (RR: 4.17), and high mitotic activity index (RR: 3.60) were found to be significant risk factors for local recurrence. The incidence of grade 2-3 side effects was higher in the boost arm (17.3% vs 7.8%; p=0.03). However, the rate of excellent/good cosmetic results was similar for the two arms (85.6% vs 91.3%; p=0.14). Cosmesis was rated as excellent/good in 88.5% of patients treated with HDR BT and 82.7% of patients with electron boost (p=0.29). Conclusions: Boost dose significantly improves LTC and RFS in patients treated with BCS and radiotherapy. In spite of the higher incidence of late side effects in the boost arm, boost dose is strongly recommended for patients at high risk for local recurrence. Positive or close margin status, high mitotic activity index, and young patient age

  1. Randomized Trial Comparing the Electronic Composite Psychosocial Screener YouthCHAT With a Clinician-Interview Assessment for Young People: A Study Protocol.

    Science.gov (United States)

    Thabrew, Hiran; Corter, Arden; Goodyear-Smith, Felicity; Goldfinch, Mary

    2017-07-31

    Psychosocial problems such as depression, anxiety, and substance abuse are common and burdensome in young people, particularly those with long-term physical conditions such as asthma and diabetes. In New Zealand, "screening" for such problems is undertaken routinely only with Year 9 students in low-decile schools and opportunistically in pediatric settings using a nonvalidated and time-consuming clinician-administered Home, Education/employment, Eating, Activity, Drugs, Sexuality, Suicide/depression, Safety (HEEADSSS) interview. The Youth version, Case-finding and Help Assessment Tool (YouthCHAT) is a relatively new, locally developed, eTablet-based composite screener for identifying similar psychosocial issues to HEEADSSS. Based on individually validated screening instruments, it is self-administered within minutes. Preliminary testing has revealed its acceptability to young people, but further research is required to expand its modules to cover all HEEADSSS domains, to evaluate its acceptability for young people with and without long-term physical conditions, and to compare its effectiveness against HEEADSSS. Our aim is to (1) ascertain acceptability and utility of YouthCHAT for children with long-term physical illness and high school students, (2) validate three additional YouthCHAT domains against comparable HEEADSSS domains, and (3) compare the performance of YouthCHAT and HEEADSSS in the high school setting. During the first phase of the study, three additional YouthCHAT domains were codesigned with high school students. During the second phase of the study, the updated version of YouthCHAT will be administered to 30 young people with long-term physical conditions, and to 150 high school students either before or after HEEADSSS in the form of a randomized trial with counter-balanced design. Primary outcomes include comparability between HEEADSSS and YouthCHAT in detecting psychosocial issues, and time to administer; acceptability of YouthCHAT as an acceptable

  2. The One-stop trial: Does electronic referral and booking by the general practitioner (GPs to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Vonen Barthold

    2008-08-01

    Full Text Available Abstract Background Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery. Materials and Methods In a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop, or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery. Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size, 25%, is significant, resulting in a sample size of 120 patients in total. Discussion Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it

  3. Evaluation of sealing ability of Biodentine™ and mineral trioxide aggregate in primary molars using scanning electron microscope: A randomized controlled in vitro trial

    Directory of Open Access Journals (Sweden)

    Allwyn Samuel

    2016-01-01

    Full Text Available Objective: The aim of this study was to compare the sealing ability of mineral trioxide aggregate (MTA and Biodentine™ when used to repair the furcal perforations in primary molars using scanning electron microscope (SEM. Study Design: The study sample comprised forty recently extracted primary molars. These teeth were placed in a 5.25% sodium hypochlorite solution for 24 h and washed with tap water. Access cavities were made using a round bur in high-speed handpiece. Perforations were made in the center of the floor of the pulpal chamber using a 0.5 mm round bur. The teeth were randomly assigned into two experimental groups based on the material used to seal the perforation: Group A - MTA and Group B - Biodentine™. The packed materials were allowed to set for 24 h. The samples were sectioned longitudinally and the extent of marginal adaptation was measured by SEM. Wilcoxon-signed rank test was used for statistical analysis using SPSS software. Results: All teeth exhibited microleakage, but Biodentine™ showed significantly less leakage (0.149 compared to MTA (0.583. Conclusion: Based on the results of this study, Biodentine™ showed lesser microleakage compared to MTA and thus may be a good alternative to MTA.

  4. Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial.

    Science.gov (United States)

    Wolfe, Joanne; Orellana, Liliana; Cook, E Francis; Ullrich, Christina; Kang, Tammy; Geyer, Jeffrey Russell; Feudtner, Chris; Weeks, Jane C; Dussel, Veronica

    2014-04-10

    This study aimed to determine whether feeding back patient-reported outcomes (PROs) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life (HRQoL). This study was a parallel, multicentered pilot randomized controlled trial. At most once per week, children age ≥ 2 years old with advanced cancer or their parent completed the computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) survey consisting of age- and respondent-adapted versions of the Memorial Symptom Assessment Scale (MSAS), Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL4.0), and an overall Sickness question. In the intervention group (n = 51), oncologists and families received printed reports summarizing PROs; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded. No feedback was provided in the control group (n = 53). Primary outcomes included linear trends of MSAS, PedsQL4.0 total and subscale scores, and Sickness scores during 20 weeks of follow-up, along with child, parent, and provider satisfaction with PediQUEST feedback. Feedback did not significantly affect average MSAS, PedsQL4.0, or Sickness score trends. Post hoc subgroup analyses among children age ≥ 8 years who survived 20 weeks showed that feedback improved PedsQL4.0 emotional (+8.1; 95% CI, 1.8 to 14.4) and Sickness (-8.2; 95% CI, -14.2 to -2.2) scores. PediQUEST reports were valued by children, parents, and providers and contributed at least sometimes to physician initiation of a psychosocial consult (56%). Although routine feedback of PROs did not significantly affect the child's symptoms or HRQoL, changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging. Importantly, children, parents, and providers value PRO feedback.

  5. Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

    Science.gov (United States)

    Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

    2016-12-15

    Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

  6. A Randomized controlled trial of intramuscular pentazocine ...

    African Journals Online (AJOL)

    pain perception was assessed using visual analog scale (VAS) scores at presentation and after delivery while maternal ... Randomized controlled trial of intramuscular pentazocine compared to intravenous paracetamol for pain relief in labour. 117. Tropical Journal of Obstetrics .... An envelope was opened by a nurse and.

  7. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Emmanuel eStip

    2013-08-01

    Full Text Available Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill® and the BARS, in order to verify whether the DoPill® provides reliable assessment of medication adherence. Methods: The DoPill® is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill® or Treatment As Usual group (TAU for six weeks. The BARS was used as a reference measure. Results: Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67 % after six weeks. DoPill® recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. Conclusion: These results suggest that DoPill® is a valid tool that provides more reliable and objective data for the clinician about their patient’s adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  8. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia.

    Science.gov (United States)

    Stip, Emmanuel; Vincent, Philippe D; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill(®) improved AAR of schizophrenic patients. Furthermore, we compared AAR obtained by the DoPill(®) and the BARS, in order to verify whether the DoPill(®) provides reliable assessment of medication adherence. The DoPill(®) is a smart pill dispenser that beeps and flashes at the appropriate time of the day. Each of its 28 compartments is covered by a plastic lamina that, when taken off, sends a signal to the pharmacist. Patients were randomized to the DoPill(®) or treatment as usual groups for 6 weeks. The BARS was used as a reference measure. Forty-six percent of patients were deemed to be non-adherent with antipsychotic medication. The mean AAR was 67% after 6 weeks. DoPill(®) recorded better AAR than some of those found in the literature and were lower than the BARS estimate we found. These results suggest that DoPill(®) is a valid tool that provides more reliable and objective data for the clinician about their patient's adherence, than existing assessment tools like the BARS. Furthermore, the device may help patients successfully manage their medication regimen.

  9. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...... and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...

  10. Randomized Clinical Trials With Biomarkers: Design Issues

    Science.gov (United States)

    McShane, Lisa M.; Korn, Edward L.

    2010-01-01

    Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367

  11. Cluster randomized trials for pharmacy practice research.

    Science.gov (United States)

    Gums, Tyler; Carter, Barry; Foster, Eric

    2016-06-01

    Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity.

  12. [Ethical aspects of randomized clinical trials].

    Science.gov (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A

    1997-01-01

    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  13. Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.

    Science.gov (United States)

    Moja, Lorenzo; Passardi, Alessandro; Capobussi, Matteo; Banzi, Rita; Ruggiero, Francesca; Kwag, Koren; Liberati, Elisa Giulia; Mangia, Massimo; Kunnamo, Ilkka; Cinquini, Michela; Vespignani, Roberto; Colamartini, Americo; Di Iorio, Valentina; Massa, Ilaria; González-Lorenzo, Marien; Bertizzolo, Lorenzo; Nyberg, Peter; Grimshaw, Jeremy; Bonovas, Stefanos; Nanni, Oriana

    2016-11-25

    Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. ClinicalTrials.gov, NCT02645357.

  14. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  15. Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial.

    Science.gov (United States)

    Sajobi, Tolulope T; Singh, Gurbakhshash; Lowerison, Mark W; Engbers, Jordan; Menon, Bijoy K; Demchuk, Andrew M; Goyal, Mayank; Hill, Michael D

    2017-11-02

    We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the "Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times" (ESCAPE) trial. The ESCAPE trial is a prospective, multicenter, randomized clinical trial that enrolled subjects with the following main inclusion criteria: less than 12 h from symptom onset, age 18 years or older, baseline NIHSS score > 5, ASPECTS score > 5 and computed tomography angiography (CTA) evidence of carotid T/L or M1-segment middle cerebral artery (MCA) occlusion, and at least moderate collaterals by CTA. Patients were randomized using a real-time, dynamic, Internet-based, minimal sufficient balance randomization method that balanced the study arms with respect to baseline covariates including age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS score and treatment with intravenously administered alteplase. Permutation-based tests of group differences confirmed group balance across several baseline covariates including sex (p = 1.00), baseline NIHSS score (p = 0.95), site of arterial occlusion (p = 1.00), baseline ASPECTS score (p = 0.28), treatment with intravenously administered alteplase (p = 0.31), and age (p = 0.67). Results from the ESCAPE trial demonstrate the feasibility and the benefit of this covariate adaptive randomization scheme in small-sample trials and for data monitoring endeavors. ESCAPE trial - NCT01778335 - at www.clinicaltrials.gov . Registered on 29 January 2013.

  16. A randomized-controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Emmanuel eStip; Emmanuel eStip; Emmanuel eStip; Philippe D. Vincent; Philippe D. Vincent; Philippe D. Vincent; Catherine eGuevremont; Simon eZhornitsky; Constantin eTranulis; Constantin eTranulis; Constantin eTranulis; Juliette eSablier; Juliette eSablier

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5 % in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improv...

  17. A randomized controlled trial with a Canadian electronic pill dispenser used to measure and improve medication adherence in patients with schizophrenia

    OpenAIRE

    Stip, Emmanuel; Vincent, Philippe D.; Sablier, Juliette; Guevremont, Catherine; Zhornitsky, Simon; Tranulis, Constantin

    2013-01-01

    Objective: Medication adherence is extremely important in preventing relapse and lowering symptoms in schizophrenic patients. However, estimates show that nearly half of these patients have poor adherence. The Brief Adherence Rating Scale (BARS) seems to be the most reliable tool assessing adherence in schizophrenia and shows that the antipsychotic adherence ratio (AAR) is about 49.5% in schizophrenia. The aim of the study was to test if an electronic pill dispenser named DoPill® improved AAR...

  18. Empirical likelihood inference in randomized clinical trials.

    Science.gov (United States)

    Zhang, Biao

    2017-01-01

    In individually randomized controlled trials, in addition to the primary outcome, information is often available on a number of covariates prior to randomization. This information is frequently utilized to undertake adjustment for baseline characteristics in order to increase precision of the estimation of average treatment effects; such adjustment is usually performed via covariate adjustment in outcome regression models. Although the use of covariate adjustment is widely seen as desirable for making treatment effect estimates more precise and the corresponding hypothesis tests more powerful, there are considerable concerns that objective inference in randomized clinical trials can potentially be compromised. In this paper, we study an empirical likelihood approach to covariate adjustment and propose two unbiased estimating functions that automatically decouple evaluation of average treatment effects from regression modeling of covariate-outcome relationships. The resulting empirical likelihood estimator of the average treatment effect is as efficient as the existing efficient adjusted estimators(1) when separate treatment-specific working regression models are correctly specified, yet are at least as efficient as the existing efficient adjusted estimators(1) for any given treatment-specific working regression models whether or not they coincide with the true treatment-specific covariate-outcome relationships. We present a simulation study to compare the finite sample performance of various methods along with some results on analysis of a data set from an HIV clinical trial. The simulation results indicate that the proposed empirical likelihood approach is more efficient and powerful than its competitors when the working covariate-outcome relationships by treatment status are misspecified.

  19. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    OpenAIRE

    Ferreira,Giovanni E.; Barreto,Rodrigo G. P.; Caroline C. Robinson; Rodrigo D. M. Plentz; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Ri...

  20. Randomized clinical trial: group counseling based on tinnitus retraining therapy

    National Research Council Canada - National Science Library

    Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E

    2007-01-01

    .... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...

  1. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...... 1995 and 2009 in which celecoxib or rofecoxib were compared with naproxen, ibuprofen or diclofenac. All articles labelled as RCTs mentioning rofecoxib or celecoxib and one or more of the comparator drugs in the title and/or abstract were included. We extracted information on doses of both non...... dose trends in the case of rofecoxib. CONCLUSIONS: Although the dose trends over time differed for RCTs comparing rofecoxib and celecoxib with diclofenac, ibuprofen or naproxen, the results of our study do not support the hypothesis that dose trends influenced the decision to continue marketing...

  2. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  3. Maximin Optimal Designs for Cluster Randomized Trials

    Science.gov (United States)

    Wu, Sheng; Wong, Weng Kee; Crespi, Catherine M.

    2017-01-01

    Summary We consider design issues for cluster randomized trials (CRTs) with a binary outcome where both unit costs and intraclass correlation coefficients (ICCs) in the two arms may be unequal. We first propose a design that maximizes cost efficiency (CE), defined as the ratio of the precision of the efficacy measure to the study cost. Because such designs can be highly sensitive to the unknown ICCs and the anticipated success rates in the two arms, a local strategy based on a single set of best guesses for the ICCs and success rates can be risky. To mitigate this issue, we propose a maximin optimal design that permits ranges of values to be specified for the success rate and the ICC in each arm. We derive maximin optimal designs for three common measures of the efficacy of the intervention, risk difference, relative risk and odds ratio, and study their properties. Using a real cancer control and prevention trial example, we ascertain the efficiency of the widely used balanced design relative to the maximin optimal design and show that the former can be quite inefficient and less robust to mis-specifications of the ICCs and the success rates in the two arms. PMID:28182835

  4. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  5. Cavity lining after excavating caries lesions: meta-analysis and trial sequential analysis of randomized clinical trials.

    Science.gov (United States)

    Schwendicke, Falk; Göstemeyer, Gerd; Gluud, Christian

    2015-11-01

    After removal of dentine caries lesions, cavity lining has been advocated. Non-clinical data support this approach, but clinical data are sparse and ambiguous. We aimed at evaluating the benefits and harms of cavity lining using meta-analysis and Trial Sequential Analysis. We included randomized clinical trials comparing restorations without versus with cavity lining for treating primary caries lesions. Only trials reporting failure (defined as need to re-retreat) after ≥1 year follow-up were included. Trial selection, data extraction, and risk of bias assessment were conducted independently by two reviewers. We conducted random-effects intention-to-treat and per-protocol meta-analyses, and Trial Sequential Analysis to control for random errors. Electronic databases (PubMed, Embase, CENTRAL) were systematically screened, and hand searches and cross-referencing performed. From 128 studies, three randomized trials (89/130 patients or teeth), all treating primary teeth, were included. The trials had high risk of bias. All trials compared no lining versus calcium hydroxide lining after selective caries removal followed by adhesive restoration. Follow-up was 36 to 53 months. Restoring the cavity without lining did not significantly affect the risk of failure (intention-to-treat relative risk (RR) (95% confidence interval) 0.71 (0.49-1.04), per-protocol RR 0.52 (0.24-1.10). According to Trial Sequential Analysis, no firm evidence was reached. The quality of evidence was very low. Strong recommendations for using cavity liners are unsubstantiated, but firm evidence for omitting lining is also unavailable. Our findings apply only to primary teeth and calcium hydroxide liner. Whilst lining is frequently performed in dental practice, very few randomized clinical trials investigated this issue. The three trials included in this review treated deciduous teeth and did not find lining with calcium hydroxide beneficial. Lining is not supported by sufficient clinical evidence

  6. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious

  7. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  8. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  9. Randomized controlled trials: still somewhat immature

    African Journals Online (AJOL)

    Adele

    2004-05-20

    May 20, 2004 ... cal trials were found to be eligible for recruitment to those studies.1 Looking at this issue from another perspective, fewer than fifteen percent of unselected patients attending a psychi- atric outpatient department clinic met eligibility criteria for inclusion into clinical trials.2,3 Results from clinical trials are.

  10. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT: A randomized, controlled non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Kristina Keitel

    2017-10-01

    Full Text Available The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer. The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH, while reducing the proportion with antibiotic prescription.We performed a randomized (at patient level, blocks of 4, controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7 by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths. We enrolled 3

  11. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research

    OpenAIRE

    Press, William H.

    2009-01-01

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case—the two-armed Bernoulli bandit problem—can be exactl...

  12. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  13. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  14. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial. CS Deshpande, A Rakshani, R Nagarathna, TS Ganpat, A Kurpad, R Maskar, DC Sudheer, HR Nagendra, R Abbas, N Raghuram, K Anura, M Rita, NH Ramarao ...

  15. European randomized lung cancer screening trials: Post NLST

    DEFF Research Database (Denmark)

    Field, JK; Klaveren, R; Pedersen, JH

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

  16. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  17. Randomized controlled trials: still somewhat immature

    African Journals Online (AJOL)

    Adele

    2004-05-20

    May 20, 2004 ... The conflict between the design of efficacy trials that give a reasonably sound answer to a very narrow question address- ing a very limited population and the design of effectiveness trials that evaluate complex questions in a more heterogeneous and “real world” population is one example. The former pro-.

  18. Mediterranean dietary pattern and depression: the PREDIMED randomized trial

    OpenAIRE

    S?nchez-Villegas, Almudena; Mart?nez-Gonz?lez, Miguel Angel; Estruch, Ram?n; Salas-Salvad?, Jordi; Corella, Dolores; Covas, Maria Isabel; Ar?s, Fernando; Romaguera, Dora; G?mez-Gracia, Enrique; Lapetra, Jos?; Pint?, Xavier; Mart?nez, Jose Alfredo; Lamuela-Ravent?s, Rosa Mar?a; Ros, Emilio; Gea, Alfredo

    2013-01-01

    BACKGROUND: A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. METHOD...

  19. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  20. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  1. Blocking nocturnal blue light for insomnia: A randomized controlled trial.

    Science.gov (United States)

    Shechter, Ari; Kim, Elijah Wookhyun; St-Onge, Marie-Pierre; Westwood, Andrew J

    2017-10-21

    The use of light-emitting electronic devices before bedtime may contribute to or exacerbate sleep problems. Exposure to blue-wavelength light in particular from these devices may affect sleep by suppressing melatonin and causing neurophysiologic arousal. We aimed to determine if wearing amber-tinted blue light-blocking lenses before bedtime improves sleep in individuals with insomnia. Fourteen individuals (n = 8 females; age ± SD 46.6 ± 11.5 y) with insomnia symptoms wore blue light-blocking amber lenses or clear placebo lenses in lightweight wraparound frames for 2 h immediately preceding bedtime for 7 consecutive nights in a randomized crossover trial (4-wk washout). Ambulatory sleep measures included the Pittsburgh Insomnia Rating Scale (PIRS) completed at the end of each intervention period, and daily post-sleep questionnaire and wrist-actigraphy. PIRS total scores, and Quality of Life, Distress, and Sleep Parameter subscales, were improved in amber vs. clear lenses condition (p-values sleep time (TST), overall quality, and soundness of sleep were significantly higher (p-values sleep in individuals with insomnia symptoms. These findings have health relevance given the broad use of light-emitting devices before bedtime and prevalence of insomnia. Amber lenses represent a safe, affordable, and easily implemented therapeutic intervention for insomnia symptoms. ClinicalTrials.gov Identifier: NCT02698800. Copyright © 2017. Published by Elsevier Ltd.

  2. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...... that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....

  3. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  4. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  5. An Update on Randomized Clinical Trials in Breast Cancer.

    Science.gov (United States)

    Barnard, Kayla; Klimberg, V Suzanne

    2017-10-01

    Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.

  6. Fool's gold, lost treasures, and the randomized clinical trial.

    Science.gov (United States)

    Stewart, David J; Kurzrock, Razelle

    2013-04-16

    Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are "equivalent" despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that "shot-gun" combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without randomized trials if they yield

  7. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): A randomized, controlled non-inferiority trial.

    Science.gov (United States)

    Keitel, Kristina; Kagoro, Frank; Samaka, Josephine; Masimba, John; Said, Zamzam; Temba, Hosiana; Mlaganile, Tarsis; Sangu, Willy; Rambaud-Althaus, Clotilde; Gervaix, Alain; Genton, Blaise; D'Acremont, Valérie

    2017-10-01

    The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI) algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs) that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter) and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer). The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH), while reducing the proportion with antibiotic prescription. We performed a randomized (at patient level, blocks of 4), controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7) by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths). We enrolled 3,192 patients

  8. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.

  9. Randomized Trial of a Lifestyle Program in Obese Infertile Women

    NARCIS (Netherlands)

    Mutsaerts, Meike A. Q.; van Oers, Anne M.; Groen, Henk; Burggraaff, Jan M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Koks, Carolien A. M.; van Golde, Ron; Kaaijk, Eugenie M.; Schierbeek, Jaap M.; Oosterhuis, Gerrit J. E.; Broekmans, Frank J.; Bemelmans, Wanda J. E.; Lambalk, Cornelis B.; Verberg, Marieke F. G.; van der Veen, Fulco; Klijn, Nicole F.; Mercelina, Patricia E. A. M.; van Kasteren, Yvonne M.; Nap, Annemiek W.; Brinkhuis, Egbert A.; Vogel, Niels E. A.; Mulder, Robert J. A. B.; Gondrie, Ed T. C. M.; de Bruin, Jan P.; Sikkema, J. Marko; de Greef, Mathieu H. G.; ter Bogt, Nancy C. W.; Land, Jolande A.; Mol, Ben W. J.; Hoek, Annemieke

    2016-01-01

    BACKGROUND Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS We randomly assigned infertile women with a body-mass index (the weight in kilograms

  10. The quality of randomized controlled trial reporting in spine literature.

    Science.gov (United States)

    Naunheim, Matthew R; Walcott, Brian P; Nahed, Brian V; Simpson, Andrew K; Agarwalla, Pankaj K; Coumans, Jean-Valery

    2011-07-15

    Retrospective literature review. To assess the quality of randomized controlled trial reporting in spine surgery. The use of the Consolidated Standards of Reporting Trials (CONSORT) criteria in clinical trials aims to improve adherence to a set of generally accepted practices in the reporting of randomized controlled trials. Randomized controlled trials in spine surgery are important sources of evidence-based practice, but the quality of their execution and reporting have not been reported adequately. All randomized controlled trials published in three selected dedicated spine journals from 2008 were reviewed with respect to the 40 criteria derived from CONSORT descriptors; 10 criteria applying to the abstract, and 30 to the body of the article. Each article was scored by three reviewers in group format for each criterion and was assigned a score. Reviewers always came to a consensus before assigning a score. A total of 32 RCTs met the inclusion criteria for this review. The average modified CONSORT score was 65%. Disclosing certain criteria was associated with a higher overall score, including method of generation of random sequence (P spine literature may thus be difficult to interpret. Greater effort must be put into compliance with these guidelines to improve data quality.

  11. A note on Harold S. Diehl, randomization, and clinical trials.

    Science.gov (United States)

    Waller, L A

    1997-04-01

    Harold S. Diehl and coworkers published results from a remarkable trial on the efficacy of vaccines for the common cold in 1938. The original report states that patients were assigned to treatment and control groups "at random." Diehl's study has been referred to as one of the first instances of a randomized, double-blind, placebo-controlled trial. No description of a formal randomization scheme is given in the 1938 report and an unpublished paper of Diehl's suggests the use of alternate assignment in the study.

  12. Publication bias in clinical trials of electronic health records.

    Science.gov (United States)

    Vawdrey, David K; Hripcsak, George

    2013-02-01

    To measure the rate of non-publication and assess possible publication bias in clinical trials of electronic health records. We searched ClinicalTrials.gov to identify registered clinical trials of electronic health records and searched the biomedical literature and contacted trial investigators to determine whether the results of the trials were published. Publications were judged as positive, negative, or neutral according to the primary outcome. Seventy-six percent of trials had publications describing trial results; of these, 74% were positive, 21% were neutral, and 4% were negative (harmful). Of unpublished studies for which the investigator responded, 43% were positive, 57% were neutral, and none were negative; the lower rate of positive results was significant (pelectronic health record studies is similar to that in other biomedical studies. There appears to be a bias toward publication of positive trials in this domain. Copyright © 2012 Elsevier Inc. All rights reserved.

  13. Management and conduct of randomized controlled trials.

    Science.gov (United States)

    Knatterud, Genell L

    2002-01-01

    In preparing to undertake a clinical trial, it may be helpful to keep in mind Fredrickson's description of clinical trials (31): "Field trials are indispensable. They will continue to be an ordeal. They lack glamour, they strain our resources and patience, and they protract the moment of truth to excruciating limits. Still, they are among the most challenging tests of our skills. I have no doubt that when the problem is well chosen, the study is appropriately designed, and that when all the populations concerned are made aware of the route and the goal, the reward can be commensurate with the effort. If, in major medical dilemmas, the alternative is to pay the costs of perpetual uncertainty, have we really any choice?"

  14. Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

    2014-06-01

    To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Methods for sample size determination in cluster randomized trials.

    Science.gov (United States)

    Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

    2015-06-01

    The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.

  16. Hypnotherapy in radiotherapy patients: A randomized trial

    NARCIS (Netherlands)

    Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT

  17. Randomized Trial of 2 Versus 1 Dose of Measles Vaccine

    DEFF Research Database (Denmark)

    Brønd, Marie; Martins, Cesario L; Byberg, Stine

    2018-01-01

    Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we investig......Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we...... measles vaccination policy might reduce hospital admissions more than the current policy of providing the first MV at 9 months of age. Trial registration: ClinicalTrials.gov identifier NCT00168558....

  18. Effectiveness of myofascial release: systematic review of randomized controlled trials.

    Science.gov (United States)

    Ajimsha, M S; Al-Mudahka, Noora R; Al-Madzhar, J A

    2015-01-01

    Myofascial release (MFR) is a form of manual therapy that involves the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function. Anecdotal evidence shows great promise for MFR as a treatment for various conditions. However, research to support the anecdotal evidence is lacking. To critically analyze published randomized controlled trials (RCTs) to determine the effectiveness of MFR as a treatment option for different conditions. Electronic databases: MEDLINE, CINAHL, Academic Search Premier, Cochrane library, and Physiotherapy Evidence Database (PEDro), with key words myofascial release and myofascial release therapy. No date limitations were applied to the searches. Articles were selected based upon the use of the term myofascial release in the abstract or key words. The final selection was made by applying the inclusion and exclusion criteria to the full text. Studies were included if they were English-language, peer-reviewed RCTs on MFR for various conditions and pain. Data collected were number of participants, condition being treated, treatment used, control group, outcome measures and results. Studies were analyzed using the PEDro scale and the Center for Evidence-Based Medicine's Levels of Evidence scale. The literature regarding the effectiveness of MFR was mixed in both quality and results. Although the quality of the RCT studies varied greatly, the result of the studies was encouraging, particularly with the recently published studies. MFR is emerging as a strategy with a solid evidence base and tremendous potential. The studies in this review may help as a respectable base for the future trials. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Design of a cluster-randomized minority recruitment trial: RECRUIT.

    Science.gov (United States)

    Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

    2017-06-01

    Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or

  20. The Danish randomized lung cancer CT screening trial

    DEFF Research Database (Denmark)

    Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger

    2009-01-01

    INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...... lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false......-positive screen results compared with previous studies on lung cancer screening....

  1. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  2. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While......The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally....... This article proposes strategies for improving the evidence base for wound care decision making....

  3. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful.......Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  4. Saffron (Crocus sativus L.) and major depressive disorder: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Hausenblas, Heather Ann; Saha, Debbie; Dubyak, Pamela Jean; Anton, Stephen Douglas

    2013-11-01

    Due to safety concerns and side effects of many antidepressant medications, herbal psychopharmacology research has increased, and herbal remedies are becoming increasingly popular as alternatives to prescribed medications for the treatment of major depressive disorder (MDD). Of these, accumulating trials reveal positive effects of the spice saffron (Crocus sativus L.) for the treatment of depression. A comprehensive and statistical review of the clinical trials examining the effects of saffron for treatment of MDD is warranted. The purpose of this study was to conduct a meta-analysis of published randomized controlled trials examining the effects of saffron supplementation on symptoms of depression among participants with MDD. We conducted electronic and non-electronic searches to identify all relevant randomized, double-blind controlled trials. Reference lists of all retrieved articles were searched for relevant studies. The criteria for study selection included the following: (1) adults (aged 18 and older) with symptoms of depression, (2) randomized controlled trial, (3) effects of saffron supplementation on depressive symptoms examined, and (4) study had either a placebo control or antidepressant comparison group. Using random effects modeling procedures, we calculated weighted mean effect sizes separately for the saffron supplementation vs placebo control groups, and for the saffron supplementation vs antidepressant groups. The methodological quality of all studies was assessed using the Jadad score. The computer software Comprehensive Meta-analysis 2 was used to analyze the data. Based on our pre-specified criteria, five randomized controlled trials (n = 2 placebo controlled trials, n = 3 antidepressant controlled trials) were included in our review. A large effect size was found for saffron supplementation vs placebo control in treating depressive symptoms (M ES = 1.62, P saffron supplementation significantly reduced depression symptoms compared to the

  5. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  6. Dry cupping for plantar fasciitis: a randomized controlled trial

    OpenAIRE

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59?years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome...

  7. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...

  8. The conduct and principles of randomized clinical trials.

    Science.gov (United States)

    Klimt, C R

    1981-05-01

    Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.

  9. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  10. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...

  11. The reporting quality of randomized controlled trials in orthodontics.

    Science.gov (United States)

    Lempesi, Evangelia; Koletsi, Despina; Fleming, Padhraig S; Pandis, Nikolaos

    2014-06-01

    Accurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting. The 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling. 128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values. The reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions. Copyright

  12. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  13. The use of electronic data capture tools in clinical trials: Web-survey of 259 Canadian trials.

    Science.gov (United States)

    El Emam, Khaled; Jonker, Elizabeth; Sampson, Margaret; Krleza-Jerić, Karmela; Neisa, Angelica

    2009-03-09

    Electronic data capture (EDC) tools provide automated support for data collection, reporting, query resolution, randomization, and validation, among other features, for clinical trials. There is a trend toward greater adoption of EDC tools in clinical trials, but there is also uncertainty about how many trials are actually using this technology in practice. A systematic review of EDC adoption surveys conducted up to 2007 concluded that only 20% of trials are using EDC systems, but previous surveys had weaknesses. Our primary objective was to estimate the proportion of phase II/III/IV Canadian clinical trials that used an EDC system in 2006 and 2007. The secondary objectives were to investigate the factors that can have an impact on adoption and to develop a scale to assess the extent of sophistication of EDC systems. We conducted a Web survey to estimate the proportion of trials that were using an EDC system. The survey was sent to the Canadian site coordinators for 331 trials. We also developed and validated a scale using Guttman scaling to assess the extent of sophistication of EDC systems. Trials using EDC were compared by the level of sophistication of their systems. We had a 78.2% response rate (259/331) for the survey. It is estimated that 41% (95% CI 37.5%-44%) of clinical trials were using an EDC system. Trials funded by academic institutions, government, and foundations were less likely to use an EDC system compared to those sponsored by industry. Also, larger trials tended to be more likely to adopt EDC. The EDC sophistication scale had six levels and a coefficient of reproducibility of 0.901 (PCanada is higher than the literature indicated: a large proportion of clinical trials in Canada use some form of automated data capture system. To inform future adoption, research should gather stronger evidence on the costs and benefits of using different EDC systems.

  14. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2016-10-01

    Traumatic Stress Disorder (PTSD) and related psychological health difficulties in Veterans and military personnel who suffer from these problems. To meet...therapy (CBT) Post-Traumatic Stress Disorder (PTSD) Randomized controlled trial (RCT) Standardized Patient (SP) ACCOMPLISHMENTS This section...were presented at the American Psychological Association (APA) 2016 Convention in August 2016. iii. A Symposium will be presented at the International

  15. A Randomized Controlled Trial Study on the Effect of Adding ...

    African Journals Online (AJOL)

    A Randomized Controlled Trial Study on the Effect of Adding Dexmedetomidine to Bupivacaine in Supraclavicular Block Using Ultrasound Guidance. ... BACKGROUND: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study ...

  16. European Randomized Lung Cancer Screening Trials : Post NLST

    NARCIS (Netherlands)

    Field, John K.; van Klaveren, Rob; Pedersen, Jesper H.; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J.

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their

  17. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  18. A double-blind randomized control trial of diazepam

    OpenAIRE

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.

  19. Robustness and Optimal Design Issues for Cluster Randomized Trials

    NARCIS (Netherlands)

    Korendijk, E.|info:eu-repo/dai/nl/072035463

    2012-01-01

    Cluster randomized trials (CRT), in which whole clusters instead of individuals are assigned to conditions, are not uncommon in the social, behavioral, educational, medical and organizational sciences. Though the assignment of individuals to treatment conditions is more efficient, this may not

  20. A Randomized Trial Comparing Lichtenstein Repair and No Mesh ...

    African Journals Online (AJOL)

    Background: The objective of this study is to compare the outcomes of Lichtenstein repair and no mesh Desarda repair for inguinal hernia. Methods: This is a prospective randomized trial of 1382 patients having 1461 hernias operated from January 2002 to December 2011.704 patients were operated using ...

  1. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  2. Infant orthopedics and facial appearance: a randomized clinical trial (Dutchcleft).

    NARCIS (Netherlands)

    Prahl, C.; Prahl-Andersen, B.; Hof, M.A. van 't; Kuijpers-Jagtman, A.M.

    2006-01-01

    OBJECTIVE: To study the effect of infant orthopedics on facial appearance. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation

  3. Assertive community treatment in the Netherlands : a randomized controlled trial

    NARCIS (Netherlands)

    Sytema, S.; Wunderink, L.; Bloemers, W.; Roorda, L.; Wiersma, D.

    Objective: Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for

  4. A randomized controlled trial comparing haemodynamic stability in ...

    African Journals Online (AJOL)

    A randomized controlled trial comparing haemodynamic stability in elderly patients undergoing spinal anaesthesia at L5, S1 versus spinal anaesthesia at L3, 4 at a ... Conventionally, spinal anaesthesia is performed at the level of L3,4 interspace; with a reported incidence of hypotension in the elderly ranging between 65% ...

  5. Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

    Science.gov (United States)

    Lawrie, Theresa A; Betrán, Ana Pilar; Singata-Madliki, Mandisa; Ciganda, Alvaro; Hofmeyr, G Justus; Belizán, José M; Purnat, Tina Dannemann; Manyame, Sarah; Parker, Catherine; Cormick, Gabriela

    2017-10-26

    The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low

  6. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  7. The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?

    Science.gov (United States)

    van der Velden, Joanne M; Verkooijen, Helena M; Young-Afat, Danny A; Burbach, Johannes Pm; van Vulpen, Marco; Relton, Clare; van Gils, Carla H; May, Anne M; Groenwold, Rolf Hh

    2017-02-01

    Randomized controlled trials (RCTs)-the gold standard for evaluating the effects of medical interventions-are notoriously challenging in terms of logistics, planning and costs. The cohort multiple randomized controlled trial approach is designed to facilitate randomized trials for pragmatic evaluation of (new) interventions and is a promising variation from conventional pragmatic RCTs. In this paper, we evaluate methodological challenges of conducting an RCT within a cohort. We argue that equally valid results can be obtained from trials conducted within cohorts as from pragmatic RCTs. However, whether this design is more efficient compared with conducting a pragmatic RCT depends on the amount and nature of non-compliance in the intervention arm. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  8. Hypnotherapy in radiotherapy patients: a randomized trial.

    Science.gov (United States)

    Stalpers, Lukas J A; da Costa, Hanna C; Merbis, Merijn A E; Fortuin, Andries A; Muller, Martin J; van Dam, Frits S A M

    2005-02-01

    To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect.

  9. Systematic review and meta-analysis of randomized trials on probiotics for hepatic encephalopathy

    DEFF Research Database (Denmark)

    Holte, Kathrine; Krag, Aleksander; Gluud, Lise Lotte

    2012-01-01

    Aim:  The objective of this systematic review and meta-analysis was to assess the efficacy of probiotics and synbiotics in patients with hepatic encephalopathy. Methods:  Eligible trials were identified by searching electronic databases including MEDLINE, the Cochrane Library, Science Citation...... Index and Embase, abstract proceedings, reference lists and ongoing trial registers until 13 October 2010. We included randomized controlled trials comparing probiotics and synbiotics with no intervention, placebo or lactulose in patients with hepatic encephalopathy. The primary outcome measure...... was improvement in hepatic encephalopathy. Results were expressed as risk rates (RR) with confidence intervals (CI) and intertrial heterogeneity as I(2) . Results:  Seven trials with a total of 393 patients were analyzed. Compared to placebo or lactulose, treatment with probiotics or synbiotics significantly...

  10. Utilization of a Smartphone Platform for Electronic Informed Consent in Acute Stroke Trials.

    Science.gov (United States)

    Haussen, Diogo C; Doppelheuer, Shannon; Schindler, Kiva; Grossberg, Jonathan A; Bouslama, Mehdi; Schultz, Meagan; Perez, Hilarie; Hall, Alex; Frankel, Michael; Nogueira, Raul G

    2017-11-01

    The informed consent process is a major limitation for enrollment in acute stroke clinical investigations. We aim to describe the novel application of smartphone electronic informed consenting (e-Consent) in trials of cerebral thrombectomy. The e-Consent tool consists of a secure/Health Insurance Portability and Accountability Act compliant smartphone platform based on REDCap (Research Electronic Data Capture; Vanderbilt University, TN) that uses a survey project located on a static webpage. A link to the webpage is sent via text message or email to the legally authorized representative. The e-Consent form is filled and a freehand electronic signature added in the smartphone browser; a record ID and an e-Consent Process Attestation form are automatically generated. The e-Consent application was piloted in a randomized trial comparing endovascular versus medical therapy in late presenting patients (DAWN [Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]). Trial enrollment began in January 2015; e-Consent was approved by the local institutional review board in December 2016, and the study was stopped in February 2017. During the trial period, Grady Memorial Hospital performed 273 thrombectomies with 47 patients being consented and 38 patients enrolled in the DAWN trial. Of the randomized patients, 29 (76%) were transferred from outside hospitals. A total of 6 surrogates were e-Consented, with 2 patients being screen failures. Enrolled e-Consented patients (n=4) had similar age (73±14 versus 69±12 years; P=0.65) and National Institutes of Health Stroke Scale (16±5 versus 16±5; P=0.88) as compared with conventionally consented (n=25). Time from door-to-randomization was decreased with e-Consenting (28±9 versus 57±24 minutes; P=0.002). e-Consenting streamlined the consenting process in a randomized trial of patients with emergent large vessel occlusion strokes. © 2017 American Heart Association, Inc.

  11. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov.

    Science.gov (United States)

    Chahal, Jaskarndip; Tomescu, S Sebastian; Ravi, Bheeshma; Bach, Bernard R; Ogilvie-Harris, Darrell; Mohamed, Nizar N; Gandhi, Rajiv

    2012-09-01

    There is increasing evidence that a significant proportion of randomized trials in medicine, and recently in orthopaedics, do not go on to publication. The objectives of this study were (1) to determine publication rates of randomized controlled trials in sports medicine that have been registered with ClinicalTrials.gov (CTG) and (2) to compare the registration summaries of randomized trials on CTG with final published manuscripts on pertinent methodological variables. Systematic review. Two independent investigators searched ClinicalTrials.gov for all closed and completed trials related to sports medicine until June 2009 using a text search strategy. The authors then searched for publications resulting from these registered trials in peer-reviewed journals that are indexed with MEDLINE and/or EMBASE as of February 2012 based on study authors and key words provided in the study protocol. Details of primary outcomes and secondary outcomes, study sponsors, and sample size were extracted and compared between registrations and publications. Of 34 closed and completed trials registered on CTG, there were 20 resultant publications in peer-reviewed journals (58.8%). There was no significant relationship between source of funding and rate of publication (P > .05). The authors found a discrepancy between the CTG registration summary and the manuscript in at least one methodological variable (primary/secondary outcomes, inclusion/exclusion criteria, sample size) in 16 of 20 (80.0%) articles and a discrepancy in the primary outcome in 8 of 20 (40.0%) published trials. Although registration of sports medicine trials in CTG does not consistently result in publication or disclosure of results at 32 months from the time of study completion, observed publication rates are higher than in other orthopaedic subspecialties. Changes are also frequently made to the final presentation of eligibility criteria and primary and secondary outcomes that are not reflected in the registered

  12. Project Management of Randomized Clinical Trials: A Narrative Review.

    Science.gov (United States)

    Goodarzynejad, Hamidreza; Babamahmoodi, Abdolreza

    2015-08-01

    A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects. Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE. Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial. Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management.

  13. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play an impor...... evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET.......Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome...

  14. Assertive community treatment in the Netherlands: a randomized controlled trial.

    Science.gov (United States)

    Sytema, S; Wunderink, L; Bloemers, W; Roorda, L; Wiersma, D

    2007-08-01

    Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for other European countries with modern mental health services. Open randomized controlled trial of long-term severely mentally ill patients [Health of the Nation Outcome Scales (HoNOS) total score >or=15], assigned to assertive community treatment (n = 59) or to standard community mental health care (n = 59). sustained contact; housing stability and admission days. This trial is registered as an International Standard Randomized Clinical Trial, number ISRCTN 11281756. Assertive community treatment was significantly better in sustaining contact with patients, but not in reducing admission days. No differences in housing stability, psychopathology, social functioning or quality of life were found. The results are in agreement with UK studies. However, the sustained contact potential of assertive community treatment is important, as too many patients are lost in standard care.

  15. A method of extracting the number of trial participants from abstracts describing randomized controlled trials.

    Science.gov (United States)

    Hansen, Marie J; Rasmussen, Nana Ø; Chung, Grace

    2008-01-01

    We have developed a method for extracting the number of trial participants from abstracts describing randomized controlled trials (RCTs); the number of trial participants may be an indication of the reliability of the trial. The method depends on statistical natural language processing. The number of interest was determined by a binary supervised classification based on a support vector machine algorithm. The method was trialled on 223 abstracts in which the number of trial participants was identified manually to act as a gold standard. Automatic extraction resulted in 2 false-positive and 19 false-negative classifications. The algorithm was capable of extracting the number of trial participants with an accuracy of 97% and an F-measure of 0.84. The algorithm may improve the selection of relevant articles in regard to question-answering, and hence may assist in decision-making.

  16. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia.

    Science.gov (United States)

    Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry

    2015-05-19

    Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors' efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups--plausibly due to differences in the mechanisms of action. Antidepressants may not worsen the course of psychosis. Better designed

  17. Sequential multiple assignment randomization trials with enrichment design.

    Science.gov (United States)

    Liu, Ying; Wang, Yuanjia; Zeng, Donglin

    2017-06-01

    Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.

  18. Ethical issues posed by cluster randomized trials in health research

    Directory of Open Access Journals (Sweden)

    Donner Allan

    2011-04-01

    Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

  19. Mediterranean dietary pattern and depression: the PREDIMED randomized trial

    Science.gov (United States)

    2013-01-01

    Background A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. Methods This was a multicenter, randomized, primary prevention field trial of cardiovascular disease (Prevención con Dieta Mediterránea (PREDIMED Study)) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease (51% of them had type 2 diabetes; DM2) attending primary care centers affiliated with 11 Spanish teaching hospitals. Primary analyses were performed on an intention-to-treat basis. Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression. Results We identified 224 new cases of depression during follow-up. There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts (multivariate hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.55 to 1.10) compared with participants assigned to the control group, although this was not significant. However, when the analysis was restricted to participants with DM2, the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance (multivariate HR = 0.59; 95% CI 0.36 to 0.98). Conclusions The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2. Trial registration This trial has been registered in the Current Controlled Trials with the number ISRCTN 35739639 PMID:24229349

  20. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial

    OpenAIRE

    Jack, Darby W.; Asante, Kwaku Poku; Blair J. Wylie; Chillrud, Steve N.; Whyatt, Robin M.; Ae-Ngibise, Kenneth A.; Quinn, Ashlinn K.; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-01-01

    Background: Household air pollution exposure is a major health risk, but validated interventions remain elusive. Methods/Design The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed seve...

  1. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010

    Directory of Open Access Journals (Sweden)

    Williams Hywel C

    2011-05-01

    Full Text Available Abstract Background Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011 covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each

  2. The SafeBoosC II randomized trial

    DEFF Research Database (Denmark)

    Plomgaard, Anne M; van Oeveren, Wim; Petersen, Tue Hvass

    2016-01-01

    BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group...... during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95...

  3. The pursuit of balance in sequential randomized trials

    Directory of Open Access Journals (Sweden)

    Raymond P. Guiteras

    2016-06-01

    Full Text Available In many randomized trials, subjects enter the sample sequentially. Because the covariates for all units are not known in advance, standard methods of stratification do not apply. We describe and assess the method of DA-optimal sequential allocation (Atkinson, 1982 for balancing stratification covariates across treatment arms. We provide simulation evidence that the method can provide substantial improvements in precision over commonly employed alternatives. We also describe our experience implementing the method in a field trial of a clean water and handwashing intervention in Dhaka, Bangladesh, the first time the method has been used. We provide advice and software for future researchers.

  4. Antibiotics for human toxoplasmosis: a systematic review of randomized trials.

    Science.gov (United States)

    Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya

    2013-06-01

    The efficacy of different treatment regimens in clinical syndromes of toxoplasmosis were assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE, EMBASE, and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on the clinical entity of toxoplasmosis. Risk of bias was evaluated and quality of evidence was graded. Fourteen randomized trials were included of which one was a non-comparative study. One well-designed trial showed that trimethoprim-sulphamethoxazole was more effective than placebo for clinical recovery of toxoplasmic lymphadenopathy in immunocompetent hosts. For toxoplasmic encephalopathy, efficacy of pyrimethamine+sulphadiazine and trimethoprim+sulphamethoxazole were similar, whereas pyrimethamine+sulphadiazine versus pyrimathamine+clindamycin showed no difference, irrespective of the outcome. Intravitreal clindamycin+dexamethasone and conventional treatment with oral pyrimethamine+sulphadiazine had similar efficacy with regard to all outcome measures in ocular toxoplasmosis, and intravitreal therapy was found to be safe. Adverse effects seemed more common with pyrimethamine+sulphadiazine. Most trials for encephalitis and ocular manifestations had a high risk of bias and were of poor methodological quality. There were no trials evaluating drugs for toxoplasmosis in pregnancy, or for congenital toxoplasmosis. Pyrimethamine+sulphadiazine is an effective therapy for treatment of toxoplasmic encephalitis; trimethoprim+sulphamethoxazole and pyrimethamine+clindamycin are possible alternatives. Treatment with either oral or intravitreal antibiotics seems reasonable for ocular toxoplasmosis. Overall, trial evidence for the efficacy of these drugs for toxoplasmosis is poor, and further well-designed trials are needed.

  5. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  6. Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial.

    Science.gov (United States)

    Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M

    2017-04-01

    Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

  7. Traditional Chinese Medicine for Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Cao, Huijuan; Lewith, George T.

    2010-01-01

    Abstract Background Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety. Objective To review systematically the beneficial and harmful effects of TCM therapies for FM. Methods We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI). Results Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, –3.21; 95% CI –4.23 to –2.11; p effect, with a random-effect model, compared with sham acupuncture (MD, –0.55; 95% CI, –1.35–0.24; p = 0.17; I2 = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, –1.66; 95% CI, –2.14 to –1.19; p effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials. Conclusions TCM therapies appear to be effective for treating FM. However, further large, rigorously designed trials are warranted because of insufficient methodological rigor in the included trials. PMID:20423209

  8. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial.

    Science.gov (United States)

    Politi, Mary C; Kuzemchak, Marie D; Kaphingst, Kimberly A; Perkins, Hannah; Liu, Jingxia; Byrne, Margaret M

    2016-12-01

    Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. ©AlphaMed Press.

  9. Levocarnitine Decreases Intradialytic Hypotension Episodes: A Randomized Controlled Trial.

    Science.gov (United States)

    Ibarra-Sifuentes, Héctor Raúl; Del Cueto-Aguilera, Ángel; Gallegos-Arguijo, Daniel Alberto; Castillo-Torres, Sergio Andres; Vera-Pineda, Raymundo; Martínez-Granados, Rolando Jacob; Atilano-Díaz, Alexandro; Cuellar-Monterrubio, Jesus Eduardo; Pezina-Cantú, Cesar Octaviano; Martínez-Guevara, Edgar de Jesús; Ortiz-Treviño, Juan Francisco; Delgado-García, Guillermo Rubén; Martínez-Jiménez, José Guadalupe; Cruz-Valdez, Jesús; Sánchez-Martínez, Concepción

    2017-10-01

    Intradialytic hypotension is common complication in stage 5 chronic kidney disease patients on hemodialysis. Incidence ranges from 15 to 30%. These patients have levocarnitine deficiency. A randomized, placebo-controlled quadruple-blinded trial was designed to demonstrate the levocarnitine efficiency on intradialytic hypotension prevention. Patients were randomized into four groups, to receive levocarnitine or placebo. During the intervention period, levocarnitine and placebo was administered 0 and 30 min before each hemodialysis session, respectively. During the trial, 33 patients received 1188 hemodialysis sessions. We identified 239 (21.3%) intradialytic hypotension episodes. The intradialytic hypotension episodes were less frequent in the levocarnitine group (9.3%, 60 IH events) (P hypotension episodes. Levocarnitine supplementation before each hemodialysis session efficiently diminishes the intradialytic hypotension episodes. This is a new application method that must be considered and explored. © 2017 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy.

  10. The effective density of randomly moving electrons and related characteristics of materials with degenerate electron gas

    Directory of Open Access Journals (Sweden)

    V. Palenskis

    2014-04-01

    Full Text Available Interpretation of the conductivity of metals, of superconductors in the normal state and of semiconductors with highly degenerate electron gas remains a significant issue if consideration is based on the classical statistics. This study is addressed to the characterization of the effective density of randomly moving electrons and to the evaluation of carrier diffusion coefficient, mobility, and other parameters by generalization of the widely published experimental results. The generalized expressions have been derived for various kinetic parameters attributed to the non-degenerate and degenerate electron gas, by analyzing a random motion of the single type carriers in homogeneous materials. The values of the most important kinetic parameters for different metals are also systematized and discussed. It has been proved that Einstein's relation between the diffusion coefficient and the drift mobility of electrons is held for any level of degeneracy if the effective density of randomly moving carriers is properly taken into account.

  11. [Randomized controlled trials terminated prematurely: beneficial therapy effects].

    Science.gov (United States)

    Kluth, L A; Rink, M; Ahyai, S A; Fisch, M; Shariat, S F; Dahm, P

    2013-08-01

    Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.

  12. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  13. CDISC standard-based electronic archiving of clinical trials.

    Science.gov (United States)

    Kuchinke, Wolfgang; Aerts, J; Semler, S C; Ohmann, C

    2009-01-01

    Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF

  14. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  15. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.

    Science.gov (United States)

    Semler, Matthew W; Wanderer, Jonathan P; Ehrenfeld, Jesse M; Stollings, Joanna L; Self, Wesley H; Siew, Edward D; Wang, Li; Byrne, Daniel W; Shaw, Andrew D; Bernard, Gordon R; Rice, Todd W

    2017-05-15

    Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown. To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids. This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction. Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98). An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

  16. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ferreira, Giovanni E; Barreto, Rodrigo G P; Robinson, Caroline C; Plentz, Rodrigo D M; Silva, Marcelo F

    2016-04-01

    To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration's Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  17. Montelukast for Postinfectious Cough: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Dong, S; Zhong, Y; Lu, W; Jaing, H; Mao, B

    2015-05-13

    To systematically assess the efficacy and safety of montelukast for postinfectious cough (PIC) and to propose a recommendation via a systematic review of all available randomized controlled trials (RCTs). Electronic databases and relevant journals were searched for RCTs from inception to July 2014. In addition, some unpublished literature was also searched. All studies included in the systematic review met the same inclusion criteria. Methodological quality and evidence quality were examined according to Cochrane handbook. The data were extracted and trial quality was assessed independently by two reviewers. Fourteen RCTs involving 1372 patients were included in our review. The methodological quality of the included trials was poor because one or more biases were observed in these studies. The quality of evidence was low to moderate levels. All trials reported better effect favouring montelukast treatment. Findings suggested that compared with other Western medication and Chinese medicine, montelukast showed significant effects in shortening cough relief time, increasing the clinic obvious effective rate, decreasing coughing frequency and severity, and improving quality of life. Adverse events were mentioned in six studies, but no serious adverse effects were reported in any of them. Montelukast demonstrated potential positive efficacy and safety for PIC; however, we could not come to a firm conclusion on the efficacy and safety of montelukast for PIC. More high quality randomized controlled trials are required to confirm the efficacy and safety of montelukast for PIC.

  18. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Giovanni E. Ferreira

    2016-01-01

    Full Text Available ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed, EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  19. Acupuncture for recurrent headaches: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Melchart, D; Linde, K; Fischer, P; White, A; Allais, G; Vickers, A; Berman, B

    1999-11-01

    To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Systematic review. Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.

  20. Effect of perioperative insulin infusion on surgical morbidity and mortality: systematic review and meta-analysis of randomized trials.7

    DEFF Research Database (Denmark)

    Gandhi, G.Y.; Murad, M.H.; Flynn, D.N.

    2008-01-01

    OBJECTIVE: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of perioperative insulin infusion on outcomes important to patients. PATIENTS AND METHODS: We used 6 search strategies including an electronic database search of MEDLINE, EMBA...

  1. A Literature Review of Randomized Controlled Trials of the Organization of Care at the End of Life

    Science.gov (United States)

    Thomas, Roger E.; Wilson, Donna; Sheps, Sam

    2006-01-01

    We searched nine electronic databases for randomized controlled trials (RCTs) about care at the end of life and found 23 RCTs. We assessed their quality using the criteria of the Cochrane Collaboration. The RCTs researched three themes: (a) the effect of providing palliative care through dedicated community teams on quality of life, on the…

  2. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  3. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  4. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    Science.gov (United States)

    2010-01-01

    Introduction To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR. Methods Twenty newly diagnosed, glucocorticoid (GC) naïve patients with PMR and 20 matched non-PMR control subjects completed the trial. Subjects were randomized in a 1:1 ratio to monotherapy with etanercept (25 mg s.c. biweekly) or placebo (saline) for 14 days. Study outcomes were assessed at baseline and after 14 days. The primary outcome was the change in PMR activity score (PMR-AS). Secondary outcomes were: changes in erythrocyte sedimentation rate (ESR) and plasma levels of TNF-α and interleukin (IL) 6; patients' functional status (health assessment questionnaire) and cumulative tramadol intake during the trial. Results At baseline, plasma TNF-α was higher in patients than in controls (P etanercept treatment (P etanercept decreased PMR-AS by 24% (P = 0.011), reflecting significant improvements in shoulder mobility, physician's global assessment and C-reactive protein, and insignificant (P > 0.05) improvements in duration of morning stiffness and patient's assessment of pain. In parallel, ESR and IL-6 were reduced (P 0.05). Functional status did not change and tramadol intake did not differ between patient groups. In controls, no changes occurred in both groups. Conclusions Etanercept monotherapy ameliorates disease activity in GC naïve patients with PMR. However, the effect is modest, indicating a minor role of TNF-α in PMR. Trial registration ClinicalTrials.gov (NCT00524381). PMID:20854662

  5. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  6. A Trial of In-Hospital, Electronic Alerts for Acute Kidney Injury: Design and Rationale

    Science.gov (United States)

    Wilson, F. Perry; Reese, Peter P.; Shashaty, Michael G.S.; Ellenberg, Susan S.; Gitelman, Yevgeniy; Bansal, Amar D; Urbani, Richard; Feldman, Harold I; Fuchs, Barry

    2014-01-01

    Background Acute Kidney Injury (AKI) is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition we previously developed an electronic alert system for AKI. To test the hypothesis that this electronic AKI alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges. Purpose To highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early, electronic alert for AKI would improve outcomes in hospitalized patients. Challenges included how to randomize the delivery of the alert system, and the ethical framework for waiving informed consent. Other methodologic challenges included the selection and statistical evaluation of our study outcome, a ranked-composite of a continuous covariate (creatinine) and two dichotomous outcomes (dialysis and death), and the use of the medical record as a source of trial data. Methods We have designed a randomized trial to assess the effectiveness of an electronic alert system for AKI. With broad inclusion criteria, and a waiver of informed consent, we enroll and randomize virtually every patient with AKI in our hospital. Results As of March 31, 2014, we have enrolled 2373 patients of 2400 targeted. Pre-alert data demonstrated a strong association between severity of AKI and inpatient mortality with a range of 6.4% in those with mild, stage 1 AKI, to 29% among those with stage 3 AKI (p<0.001). We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention. Conclusions Our study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for AKI without obtaining

  7. A randomized control trial evaluating fluorescent ink versus dark ink tattoos for breast radiotherapy.

    Science.gov (United States)

    Landeg, Steven J; Kirby, Anna M; Lee, Steven F; Bartlett, Freddie; Titmarsh, Kumud; Donovan, Ellen; Griffin, Clare L; Gothard, Lone; Locke, Imogen; McNair, Helen A

    2016-12-01

    The purpose of this UK study was to evaluate interfraction reproducibility and body image score when using ultraviolet (UV) tattoos (not visible in ambient lighting) for external references during breast/chest wall radiotherapy and compare with conventional dark ink. In this non-blinded, single-centre, parallel group, randomized control trial, patients were allocated to receive either conventional dark ink or UV ink tattoos using computer-generated random blocks. Participant assignment was not masked. Systematic (∑) and random (σ) setup errors were determined using electronic portal images. Body image questionnaires were completed at pre-treatment, 1 month and 6 months to determine the impact of tattoo type on body image. The primary end point was to determine that UV tattoo random error (σsetup) was no less accurate than with conventional dark ink tattoos, i.e. tattoos. 45 patients completed treatment (UV: n = 23, dark: n = 22). σsetup for the UV tattoo group was tattoo group compared with the dark ink group at 1 month [56% (13/23) vs 14% (3/22), respectively] and 6 months [52% (11/21) vs 38% (8/21), respectively]. UV tattoos were associated with interfraction setup reproducibility comparable with conventional dark ink. Patients reported a more favourable change in body image score up to 6 months following treatment. Advances in knowledge: This study is the first to evaluate UV tattoo external references in a randomized control trial.

  8. Effectiveness of topic-specific infobuttons: a randomized controlled trial.

    Science.gov (United States)

    Del Fiol, Guilherme; Haug, Peter J; Cimino, James J; Narus, Scott P; Norlin, Chuck; Mitchell, Joyce A

    2008-01-01

    Infobuttons are decision support tools that provide links within electronic medical record systems to relevant content in online information resources. The aim of infobuttons is to help clinicians promptly meet their information needs. The objective of this study was to determine whether infobutton links that direct to specific content topics ("topic links") are more effective than links that point to general overview content ("nonspecific links"). Randomized controlled trial with a control and an intervention group. Clinicians in the control group had access to nonspecific links, while those in the intervention group had access to topic links. Infobutton session duration, number of infobutton sessions, session success rate, and the self-reported impact that the infobutton session produced on decision making. The analysis was performed on 90 subjects and 3,729 infobutton sessions. Subjects in the intervention group spent 17.4% less time seeking for information (35.5 seconds vs. 43 seconds, p = 0.008) than those in the control group. Subjects in the intervention group used infobuttons 20.5% (22 sessions vs. 17.5 sessions, p = 0.21) more often than in the control group, but the difference was not significant. The information seeking success rate was equally high in both groups (89.4% control vs. 87.2% intervention, p = 0.99). Subjects reported a high positive clinical impact (i.e., decision enhancement or knowledge update) in 62% of the sessions. Limitations The exclusion of users with a low frequency of infobutton use and the focus on medication-related information needs may limit the generalization of the results. The session outcomes measurement was based on clinicians' self-assessment and therefore prone to bias. The results support the hypothesis that topic links are more efficient than nonspecific links regarding the time seeking for information. It is unclear whether the statistical difference demonstrated will result in a clinically significant impact

  9. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  10. Effects of auriculotherapy on labour pain: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Reginaldo Roque Mafetoni

    Full Text Available Abstract OBJECTIVE Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. METHOD This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. RESULTS No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes; caesarean section rates were higher in the placebo group (50% and the same in the other groups (10%. CONCLUSION Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj.

  11. Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

    Science.gov (United States)

    King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.

    2012-01-01

    Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670

  12. Randomized trial of tapas acupressure technique for weight loss maintenance

    Directory of Open Access Journals (Sweden)

    Elder Charles R

    2012-03-01

    Full Text Available Abstract Background Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. Methods Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®, or a control intervention comprised of social-support group meetings (SS led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. Results Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd = 11, mean BMI at randomization was 34 (sd = 5, and mean initial weight loss was 9.8 kg (sd = 5. In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85 weight regain for TAT and 2.96 kg (se 0.96 weight regain for SS, p post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. Conclusions The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary

  13. Randomized controlled trials – a matter of design

    Directory of Open Access Journals (Sweden)

    Spieth PM

    2016-06-01

    Full Text Available Peter Markus Spieth,1,2 Anne Sophie Kubasch,3 Ana Isabel Penzlin,4 Ben Min-Woo Illigens,2,5 Kristian Barlinn,6 Timo Siepmann2,6,7 1Department of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, 2Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, 3Pediatric Rheumatology and Immunology, Children’s Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, 4Institute of Clinical Pharmacology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 5Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; 6Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 7Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, Oxfordshire, UK Abstract: Randomized controlled trials (RCTs are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1 clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2 both significant and nonsignificant results should be objectively

  14. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials.

    Science.gov (United States)

    Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L

    2013-03-01

    Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.

  15. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    Science.gov (United States)

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  16. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014

  17. Herbal Medicines for Parkinson's Disease: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Kim, Tae-Hun; Cho, Ki-Ho; Jung, Woo-Sang; Lee, Myeong Soo

    2012-01-01

    Objective We conducted systematic review to evaluate current evidence of herbal medicines (HMs) for Parkinson's disease (PD). Methods Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs), quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. Results From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. Conclusion Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future. PMID:22615738

  18. Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial.

    Science.gov (United States)

    Courtright, Katherine R; Madden, Vanessa; Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea; Casarett, David; Ersek, Mary; Cassel, J Brian; Nicholas, Lauren Hersch; Escobar, Gabriel; Hill, Sarah H; O'Brien, Dan; Vogel, Mark; Halpern, Scott D

    2016-09-01

    The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS) study is a pragmatic, stepped-wedge, cluster randomized trial designed to test the efficacy and costs of specialized palliative care consultative services for hospitalized patients with advanced chronic obstructive pulmonary disease, dementia, or end-stage renal disease, as well as the overall effectiveness of ordering such services by default. Additional aims are to identify the types of services that are most beneficial and the types of patients most likely to benefit, including comparisons between ward and intensive care unit patients. We hypothesize that patient-centered outcomes can be improved without increasing costs by simply changing the default option for palliative care consultation from opt-in to opt-out for patients with life-limiting illnesses. Patients aged 65 years or older are enrolled at 11 hospitals using an integrated electronic health record. As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, electronic health record-based algorithm, and all outcomes are captured via the electronic health record and billing systems data. The time at which each hospital transitions from control, opt-in palliative care consultation to intervention, opt-out consultation is randomly assigned. The primary outcome is a composite measure of in-hospital mortality and length of stay. Secondary outcomes include palliative care process measures and clinical and economic outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT02505035).

  19. Transcranial direct current stimulation in post-stroke dysphagia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kavian Ghandehari

    2016-07-01

    Full Text Available Introduction: The aim of this research was to systematically review all the randomized controlled trials that have evaluated the effect of transcranial direct current stimulation (tDCS on post-stroke dysphagia. Methods: Three electronic databases were searched for relevant articles that were uploaded from their inception to March 2015: PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials, and Scopus. All data was that was related to the location of the cerebrovascular accident (CVA, the parameters of tDCS, post-stroke time to commencement of tDCS, the stimulated hemisphere, stimulation dose, any outcome measurements, and follow-up duration were extracted and assessed. Finally, a number of observations were generated through a qualitative synthesis of the extracted data.Result: Three eligible randomized controlled trials were included in the systematic review. All three trials reported that, in comparison to a placebo, tDCS had a statistically significant effect on post-stroke dysphagia.Discussion: The results of our systematic review suggest that tDCS may represent a promising novel treatment for post-stroke dysphagia. However, to date, little is known about the optimal parameters of tDCS for relieving post-stroke dysphagia. Further studies are warranted to refine this promising intervention by exploring the optimal parameters of tDCS.Conclusion: Since brainstem swallowing centers have bilateral cortical innervations, measures that enhance cortical input and sensorimotor control of brainstem swallowing may facilitate recovery from dysphagia.

  20. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial

    DEFF Research Database (Denmark)

    Faurholt-Jepsen, Maria; Frost, Mads; Ritz, Christian

    2015-01-01

    investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. METHOD: A total of 78 patients with bipolar disorder...... according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use...... of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. RESULTS: Intention-to-treat analyses using linear mixed models...

  1. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

    DEFF Research Database (Denmark)

    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    evaluated in the eligible trials. RESULTS: Thirty-five eligible trials were identified. The majority of them were conducted in Asia, used community as randomization unit, and had less than 10,000 participants. To minimize confounding, 23 of the 35 trials had stratified, blocked, or paired the clusters...... before they were randomized, while 17 had adjusted for confounding in the analysis. Ten of the 35 trials did not account for clustering in sample size calculations, and seven did not account for the cluster-randomized design in the analysis. The number of cluster-randomized trials increased over time......To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...

  2. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  3. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    Science.gov (United States)

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  4. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    OpenAIRE

    Lois Biener; Eunyoung Song; Sutfin, Erin L.; John Spangler; Mark Wolfson

    2015-01-01

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported ...

  5. Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Guoyan Yang

    Full Text Available Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease.We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249.20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A.Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the included trials.

  6. Fluoride concentration from dental sealants: a randomized clinical trial.

    Science.gov (United States)

    Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P

    2013-07-01

    A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.

  7. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    Science.gov (United States)

    Sawada, Hideyuki; Oeda, Tomoko; Kuno, Sadako; Nomoto, Masahiro; Yamamoto, Kenji; Yamamoto, Mitsutoshi; Hisanaga, Kinya; Kawamura, Takashi

    2010-12-31

    Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day) or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS) during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias), part IVb (motor fluctuations), and part III (motor function). RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores. Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. UMIN Clinical Trial Registry UMIN000000780.

  8. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  9. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  10. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial.

    Science.gov (United States)

    Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine

    2017-04-01

    Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; Pquality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.

  11. A randomized trial of colchicine for acute pericarditis.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Cemin, Roberto; Ferrua, Stefania; Maggiolini, Stefano; Beqaraj, Federico; Demarie, Daniela; Forno, Davide; Ferro, Silvia; Maestroni, Silvia; Belli, Riccardo; Trinchero, Rita; Spodick, David H; Adler, Yehuda

    2013-10-17

    Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; Ppericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

  12. The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

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    Karline Treurnicht Naylor

    2011-01-01

    Full Text Available The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain. Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention.

  13. Acupoint Stimulation for Fibromyalgia: A Systematic Review of Randomized Controlled Trials

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    Huijuan Cao

    2013-01-01

    Full Text Available Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials.

  14. Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

    OpenAIRE

    Toledo, Estefanía; Hu, F. B.; Estruch Riba, Ramon; Buil-Cosiales, P.; Corella Piquer, Dolores; Salas Salvadó, Jordi; Covas Planells, María Isabel; Arós, Fernando; Gómez-Gracia, E.; Fiol Sala, Miguel; Lapetra, José; Serra Majem, Lluís; Pintó Sala, Xavier; Lamuela Raventós, Rosa Ma.; Sáez Tormo, Guillermo

    2013-01-01

    BACKGROUND: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. METHODS: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for car...

  15. Magnesium treatment in alcoholics: A randomized clinical trial

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    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  16. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Hideyuki Sawada

    Full Text Available BACKGROUND: Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. METHODS: In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias, part IVb (motor fluctuations, and part III (motor function. RESULTS: RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5. UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD of 1.83 (1.56] compared with placebo-treated patients [0.03 (1.51]. However, there were no significant effects on UPDRS-IVb or III scores. CONCLUSIONS: Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000000780.

  17. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    Science.gov (United States)

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  19. Culturally appropriate storytelling to improve blood pressure: a randomized trial.

    Science.gov (United States)

    Houston, Thomas K; Allison, Jeroan J; Sussman, Marc; Horn, Wendy; Holt, Cheryl L; Trobaugh, John; Salas, Maribel; Pisu, Maria; Cuffee, Yendelela L; Larkin, Damien; Person, Sharina D; Barton, Bruce; Kiefe, Catarina I; Hullett, Sandral

    2011-01-18

    Storytelling is emerging as a powerful tool for health promotion in vulnerable populations. However, these interventions remain largely untested in rigorous studies. To test an interactive storytelling intervention involving DVDs. Randomized, controlled trial in which comparison patients received an attention control DVD. Separate random assignments were performed for patients with controlled or uncontrolled hypertension. (ClinicalTrials.gov registration number: NCT00875225) An inner-city safety-net clinic in the southern United States. 230 African Americans with hypertension. 3 DVDs that contained patient stories. Storytellers were drawn from the patient population. The outcomes were differential change in blood pressure for patients in the intervention versus the comparison group at baseline, 3 months, and 6 to 9 months. 299 African American patients were randomly assigned between December 2007 and May 2008 and 76.9% were retained throughout the study. Most patients (71.4%) were women, and the mean age was 53.7 years. Baseline mean systolic and diastolic pressures were similar in both groups. Among patients with baseline uncontrolled hypertension, reduction favored the intervention group at 3 months for both systolic (11.21 mm Hg [95% CI, 2.51 to 19.9 mm Hg]; P = 0.012) and diastolic (6.43 mm Hg [CI, 1.49 to 11.45 mm Hg]; P = 0.012) blood pressures. Patients with baseline controlled hypertension did not significantly differ over time between study groups. Blood pressure subsequently increased for both groups, but between-group differences remained relatively constant. This was a single-site study with 23% loss to follow-up and only 6 months of follow-up. The storytelling intervention produced substantial and significant improvements in blood pressure for patients with baseline uncontrolled hypertension. Finding Answers: Disparities Research for Change, a national program of the Robert Wood Johnson Foundation.

  20. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial.

    Science.gov (United States)

    Callahan, Christopher M; Boustani, Malaz A; Schmid, Arlene A; LaMantia, Michael A; Austrom, Mary G; Miller, Douglas K; Gao, Sujuan; Ferguson, Denisha Y; Lane, Kathleen A; Hendrie, Hugh C

    2017-02-07

    Alzheimer disease results in progressive functional decline, leading to loss of independence. To determine whether collaborative care plus 2 years of home-based occupational therapy delays functional decline. Randomized, controlled clinical trial. (ClinicalTrials.gov: NCT01314950). Urban public health system. 180 community-dwelling participants with Alzheimer disease and their informal caregivers. All participants received collaborative care for dementia. Patients in the intervention group also received in-home occupational therapy delivered in 24 sessions over 2 years. The primary outcome measure was the Alzheimer's Disease Cooperative Study Group Activities of Daily Living Scale (ADCS ADL); performance-based measures included the Short Physical Performance Battery (SPPB) and Short Portable Sarcopenia Measure (SPSM). At baseline, clinical characteristics did not differ significantly between groups; the mean Mini-Mental State Examination score for both groups was 19 (SD, 7). The intervention group received a median of 18 home visits from the study occupational therapists. In both groups, ADCS ADL scores declined over 24 months. At the primary end point of 24 months, ADCS ADL scores did not differ between groups (mean difference, 2.34 [95% CI, -5.27 to 9.96]). We also could not definitively demonstrate between-group differences in mean SPPB or SPSM values. The results of this trial are indeterminate and do not rule out potential clinically important effects of the intervention. The authors could not definitively demonstrate whether the addition of 2 years of in-home occupational therapy to a collaborative care management model slowed the rate of functional decline among persons with Alzheimer disease. This trial underscores the burden undertaken by caregivers as they provide care for family members with Alzheimer disease and the difficulty in slowing functional decline. National Institute on Aging.

  1. Cognitive Function in a Randomized Trial of Evolocumab.

    Science.gov (United States)

    Giugliano, Robert P; Mach, François; Zavitz, Kenton; Kurtz, Christopher; Im, Kyungah; Kanevsky, Estella; Schneider, Jingjing; Wang, Huei; Keech, Anthony; Pedersen, Terje R; Sabatine, Marc S; Sever, Peter S; Robinson, Jennifer G; Honarpour, Narimon; Wasserman, Scott M; Ott, Brian R

    2017-08-17

    Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (Pfunction was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .).

  2. A pilot randomized controlled trial of EKG for neonatal resuscitation.

    Directory of Open Access Journals (Sweden)

    Anup Katheria

    Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

  3. Family presence during brain death evaluation: a randomized controlled trial*.

    Science.gov (United States)

    Tawil, Isaac; Brown, Lawrence H; Comfort, David; Crandall, Cameron S; West, Sonlee D; Rollstin, Amber D; Dettmer, Todd S; Malkoff, Marc D; Marinaro, Jonathan

    2014-04-01

    To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress. Randomized controlled trial. Four ICUs at an academic tertiary care center. Immediate family members of patients suspected to have suffered brain death. Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone. All randomized subjects were administered a validated "understanding brain death" survey before and after the intervention. Subjects were assessed for psychological well-being between 30 and 90 days after the intervention. Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire. Brain death understanding, Impact of Event Scale, and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests. Analyses were adjusted for within family correlation. Fifty-eight family members of 17 patients undergoing brain death evaluation were enrolled: 38 family members were present for 11 brain death evaluations and 20 family members were absent for six brain death evaluations. Baseline understanding scores were similar between groups (median 3.0 [presence group] vs 2.5 [control], p = 0.482). Scores increased by a median of 2 (interquartile range, 1-2) if present versus 0 (interquartile range, 0-0) if absent (p Family presence during brain death evaluation improves understanding of brain death with no apparent adverse impact on psychological well-being. Family presence during brain death evaluation is feasible and safe.

  4. Placement Of Cardiac PacemaKEr Trial (POCKET) - rationale and design: a randomized controlled trial.

    Science.gov (United States)

    Magnusson, Peter; Wennström, Leo; Kastberg, Robert; Liv, Per

    2017-01-01

    A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs) to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET). The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years) and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS) 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device). POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  5. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions

    National Research Council Canada - National Science Library

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-01-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...

  6. The effects of motivation feedback in patients with severe mental illness : A cluster randomized controlled trial

    NARCIS (Netherlands)

    Jochems, E.C.; van der Feltz-Cornelis, C.M.; van Dam, A.; Duivenvoorden, H.J.; Mulder, C.L.

    2015-01-01

    Objective: To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods: Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968).

  7. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial

  8. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  9. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

    Directory of Open Access Journals (Sweden)

    Guallar Eliseo

    2010-12-01

    Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

  10. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  11. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  12. Case-based reasoning using electronic health records efficiently identifies eligible patients for clinical trials.

    Science.gov (United States)

    Miotto, Riccardo; Weng, Chunhua

    2015-04-01

    To develop a cost-effective, case-based reasoning framework for clinical research eligibility screening by only reusing the electronic health records (EHRs) of minimal enrolled participants to represent the target patient for each trial under consideration. The EHR data--specifically diagnosis, medications, laboratory results, and clinical notes--of known clinical trial participants were aggregated to profile the "target patient" for a trial, which was used to discover new eligible patients for that trial. The EHR data of unseen patients were matched to this "target patient" to determine their relevance to the trial; the higher the relevance, the more likely the patient was eligible. Relevance scores were a weighted linear combination of cosine similarities computed over individual EHR data types. For evaluation, we identified 262 participants of 13 diversified clinical trials conducted at Columbia University as our gold standard. We ran a 2-fold cross validation with half of the participants used for training and the other half used for testing along with other 30 000 patients selected at random from our clinical database. We performed binary classification and ranking experiments. The overall area under the ROC curve for classification was 0.95, enabling the highlight of eligible patients with good precision. Ranking showed satisfactory results especially at the top of the recommended list, with each trial having at least one eligible patient in the top five positions. This relevance-based method can potentially be used to identify eligible patients for clinical trials by processing patient EHR data alone without parsing free-text eligibility criteria, and shows promise of efficient "case-based reasoning" modeled only on minimal trial participants. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association.

  13. The Sexunzipped trial: young people's views of participating in an online randomized controlled trial.

    Science.gov (United States)

    Nicholas, Angela; Bailey, Julia V; Stevenson, Fiona; Murray, Elizabeth

    2013-12-12

    Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Our goal was to determine participants' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and

  14. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Science.gov (United States)

    Cooley, Kieran; Szczurko, Orest; Perri, Dan; Mills, Edward J; Bernhardt, Bob; Zhou, Qi; Seely, Dugald

    2009-08-31

    Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (pbenefit. No serious adverse reactions were observed in either group. Many patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make

  15. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  16. Mirtazapine to reduce methamphetamine use: a randomized controlled trial.

    Science.gov (United States)

    Colfax, Grant N; Santos, Glenn-Milo; Das, Moupali; Santos, Deirdre McDermott; Matheson, Tim; Gasper, James; Shoptaw, Steve; Vittinghoff, Eric

    2011-11-01

    No approved pharmacologic treatments for methamphetamine dependence exist. Methamphetamine use is associated with high morbidity and is a major cofactor in the human immunodeficiency virus epidemic among men who have sex with men (MSM). To determine whether mirtazapine would reduce methamphetamine use among MSM who are actively using methamphetamine. Double-blind, randomized, controlled, 12-week trial of mirtazapine vs placebo conducted from September 5, 2007, to March 4, 2010. San Francisco Department of Public Health. Participants were actively using, methamphetamine-dependent, sexually active MSM seen weekly for urine sample collection and substance use counseling. Random assignment to daily oral mirtazapine (30 mg) or placebo; both arms included 30-minute weekly substance use counseling. The primary study outcome was reduction in methamphetamine-positive urine test results. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems) and sexual risk behavior. Sixty MSM were randomized, 85% of follow-up visits were completed, and 56 participants (93%) completed the final visit. In the primary intent-to-treat analysis, participants assigned to the mirtazapine group had fewer methamphetamine-positive urine test results compared with participants assigned to the placebo group (relative risk, 0.57; 95% CI, 0.35-0.93, P = .02). Urine positivity decreased from 67% (20 of 30 participants) to 63% (17 of 27) in the placebo arm and from 73% (22 of 30) to 44% (12 of 27) in the mirtazapine arm. The number needed to treat to achieve a negative weekly urine test result was 3.1. Adherence was 48.5% by medication event monitoring systems and 74.7% by self-report; adherence measures were not significantly different between arms (medication event monitoring systems, P = .82; self-report, P = .92). Most sexual risk behaviors decreased significantly more among participants taking mirtazapine compared with those taking placebo

  17. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

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

    Science.gov (United States)

    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 indirect pulp capping, but CH showed superior dentin color and consistency after 3 months.

  19. Naturopathic care for chronic low back pain: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Orest Szczurko

    Full Text Available OBJECTIVE: Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. METHODS: This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39 or standardized physiotherapy (n = 36 over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes. RESULTS: Sixty-nine participants (92% completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001 as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001 and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045. All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001, weight-loss (p = 0.0052 and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01. CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials

  20. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  1. Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer

    Directory of Open Access Journals (Sweden)

    Rada Gabriel

    2013-02-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer. Methods We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH, low molecular weight heparin (LMWH, direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication. Results We included 67 RCTs with 24,071 participants. In twenty one trials (31% DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%, 22 (33%, and 11 (16% trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%, adequate allocation concealment (61%, participants’ blinding (39%, data collectors’ blinding (44%, providers’ blinding (41%, outcome assessors’ blinding (75%, data analysts’ blinding (15%, intention to treat analysis (57%, no selective outcome reporting (12%, no stopping early for benefit (97%. The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time. Conclusions Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological

  2. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial.

    Science.gov (United States)

    Newton, Katherine M; Reed, Susan D; Guthrie, Katherine A; Sherman, Karen J; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S; Learman, Lee A; Freeman, Ellen W; Cohen, Lee S; Joffe, Hadine; Anderson, Garnet L; Larson, Joseph C; Hunt, Julie R; Ensrud, Kristine E; LaCroix, Andrea Z

    2014-04-01

    This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

  3. Merocel versus Nasopore for nasal packing: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Jianzhang Wang

    Full Text Available OBJECTIVE: To compare the clinical outcomes, including efficacy and complications, of Merocel versus Nasopore as a nasal packing material after nasal surgery. METHODS: Relevant randomized controlled trials were identified from electronic databases (The Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure and Chinese Biomedical Database. Conference proceedings and references from identified trials and review articles were also searched. Outcome measures were pain during nasal packing, pain and bleeding upon packing removal, pressure sensation, nasal blockage, formation of synechiae, mucosal healing, and patients' general satisfaction. RESULTS: Seven randomized controlled trials met criteria for analysis. Compared with Merocel, Nasopore significantly reduced patients' subjective symptoms including in situ pain (pain experienced while packing is in place, nasal pressure, pain and bleeding during packing removal, and increased patients' general satisfaction with nasal packing. There were no significant differences in nasal obstruction, adhesion and mucosal healing between the Merocel and Nasopore groups. CONCLUSIONS: Preliminary evidence suggests that Nasopore may be superior to Merocel as a nasal packing material with regard to in situ pain, pain and bleeding upon removal, pressure, and general satisfaction and does not differ from Merocel in terms of nasal obstruction, tissue adhesion, and long-term mucosal healing.

  4. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  5. Risk of bias in randomized trials of pharmacological interventions in children and adults.

    Science.gov (United States)

    Sinha, Yashwant K; Craig, Jonathan C; Sureshkumar, Premala; Hayen, Andrew; Brien, Jo-anne E

    2014-08-01

    To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n=100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P=.002) and blinding of outcome assessment (63% pediatric, 48% adult, P=.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

    Science.gov (United States)

    Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles

    2017-01-01

    Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting

  7. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial

    National Research Council Canada - National Science Library

    Sarah Mummah; Thomas N Robinson; Maya Mathur; Sarah Farzinkhou; Stephen Sutton; Christopher D Gardner

    2017-01-01

    Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials...

  8. The reporting of blinding in physical medicine and rehabilitation randomized controlled trials: a systematic review

    National Research Council Canada - National Science Library

    Villamar, Mauricio F; Contreras, Vanessa Suárez; Kuntz, Richard E; Fregni, Felipe

    2013-01-01

    .... We searched MEDLINE via PubMed for all randomized controlled trials published in American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Clinical...

  9. Randomized trial testing the effect of peer education at increasing fruit and vegetable intake

    National Research Council Canada - National Science Library

    Buller, D B; Morrill, C; Taren, D; Aickin, M; Sennott-Miller, L; Buller, M K; Larkey, L; Alatorre, C; Wentzel, T M

    1999-01-01

    .... In a randomized trial, peer education was tested for effectiveness at increasing fruit and vegetable intake among lower socioeconomic, multicultural labor and trades employees. Employees (n = 2091...

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

    Science.gov (United States)

    2014-01-01

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

  11. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review.

    Science.gov (United States)

    Chowers, Michal Y; Gottesman, Bat Sheva; Leibovici, Leonard; Pielmeier, Ulrike; Andreassen, Steen; Paul, Mical

    2009-08-01

    Our objectives were to systematically assess the quality of reporting of adverse events (AEs) in publications of randomized trials of highly active antiretroviral therapy (HAART), and to examine whether reporting quality affects the effect estimates reported for AEs. We searched the PubMed, Cochrane library and EMBASE electronic databases up to December 2008. We included all published randomized controlled trials assessing HAART for treatment-naive adult HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting was extracted according to CONSORT guidelines. We pooled the relative risks for AEs and compared results by sponsorship and different reporting methods. Forty-nine trials, including 19 882 patients, published between 2000 and 2008, met the inclusion criteria. Only one of the trials reported on AE collection methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did not refer to the attribution methods. AE reporting was nearly always selective and selection criteria were highly variable, based on severity grading or occurrence threshold. Presentation of AEs above an occurrence threshold was more common in studies sponsored by industry (30/31) than in studies sponsored by non-profit organizations (3/18). Moreover, we showed that differences in the methods of reporting AEs may affect the results reported for AEs. No significant improvement in AE reporting was seen over this period. We found substantial variability in AE reporting. Variability was influenced by sponsor identity and affected outcomes. These facts obstruct our ability to choose HAART based on currently published data.

  12. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

    National Research Council Canada - National Science Library

    Franzoi, Mariana André Honorato; Goulart, Cristina Bretas; Lara, Elizabete Oliveira; Martins, Gisele

    2016-01-01

    ...: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26) and control group (n = 26...

  13. PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

    Science.gov (United States)

    Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

    2017-04-01

    Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization

  14. Hyperbaric oxygen therapy for treatment of children with autism: a systematic review of randomized trials

    Directory of Open Access Journals (Sweden)

    Ghanizadeh Ahmad

    2012-05-01

    Full Text Available Abstract There is a controversy about the efficacy of hyperbaric oxygen (HBO therapy for the treatment of autism. This study systematically reviews the current evidences for treating of autism with HBO therapy. According to PRISMA guidelines for a systematic review, the databases of MEDLINE/Pubmed, Google Scholar, and Randomised Controlled Trials in Hyperbaric Medicine were electronically searched. In addition, medical subject heading terms and text words for hyperbaric oxygen therapy and autism were used. The main inclusion criteria were published studies which reported the original data from the trials conducted on the patients with autism and assessed outcomes with a valid and reliable instrument. A quality assessment was also conducted. The electronically search resulted in 18 title of publications. Two studies were randomized, double-blind, controlled-clinical trials. While some uncontrolled and controlled studies suggested that HBO therapy is effective for the treatment of autism, these promising effects are not replicated. Therefore, sham-controlled studies with rigorous methodology are required to be conducted in order to provide scientific evidence-based HBO therapy for autism treatment.

  15. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniela Mapelli

    2013-08-01

    Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.

  16. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  17. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    with the intention-to-treat principle. Results: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin......Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  18. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin......BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  19. Should We Still Believe in Randomized Controlled Trials in Nephrology?

    Science.gov (United States)

    Cortinovis, Monica; Perico, Norberto; Remuzzi, Giuseppe

    2017-01-01

    The randomized controlled trial (RCT) is the cornerstone upon which clinical decision-making is based. Pivotal RCTs in the nephrology area efficiently demonstrated the renoprotective effects of treatment with renin-angiotensin system inhibitors in patients with diabetic and non-diabetic proteinuric nephropathies. However, there is concern about the increasing cost, complexity and duration of clinical studies. Moreover, recent large RCTs addressing key issues for patients with renal disease failed to achieve definitive conclusions mainly due to critical flaws in the investigational strategies, including the adoption of excessive/fixed doses of the study medications, inappropriate use of the placebo-controlled design, enrollment of low-risk individuals, poor reporting of adverse events or unreliable evaluation of renal function. The information now available on the biases that characterize the current RCTs should serve as a tool to rethink the design, patient selection and implementation of future RCTs in nephrology. © 2016 S. Karger AG, Basel.

  20. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR ...) characteristic. Results: We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7...

  1. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E

    2013-01-01

    . Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care......In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed....... Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards...

  2. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  3. Randomized Trial of a Brief Depression Prevention Program

    Science.gov (United States)

    Stice, Eric; Burton, Emily; Bearman, Sarah Kate; Rohde, Paul

    2008-01-01

    This trial compared a brief group cognitive-behavioral (CBT) depression prevention program to a waitlist control condition and four placebo or alternative interventions. High-risk adolescents with elevated depressive symptoms (N = 225, M age = 18, 70% female) were randomized to CBT, supportive-expressive group intervention, bibliotherapy, expressive writing, journaling, or waitlist conditions and completed assessments at baseline, termination, and 1-month and 6-month follow-up. All five active interventions showed significantly greater reductions in depressive symptoms at termination than waitlist controls; effects for CBT and bibliotherapy persisted into follow-up. CBT, supportive-expressive, and bibliotherapy participants also showed significantly greater decreases in depressive symptoms than expressive writing and journaling participants at certain follow-up points. Findings suggest there may be multiple ways to reduce depressive symptoms in high-risk adolescents, although expectancies, demand characteristics, and attention may have contributed to the observed effects. PMID:17007812

  4. Electronic properties of Fibonacci and random Si-Ge chains

    Energy Technology Data Exchange (ETDEWEB)

    Vasconcelos, M S [Escola de Ciencias e Tecnologia, Universidade Federal do Rio Grande do Norte, 59072-970 Natal-RN (Brazil); Azevedo, David L; Hadad, A [Departamento de Fisica, Universidade Federal do Maranhao 65080-040, Sao LuIs-MA (Brazil); Galvao, D S, E-mail: mvasconcelos@ect.ufrn.br [Instituto de Fisica Gleb Wataghin, Universidade Estadual de Campinas CP 6165, 13083-970 Campinas, SP (Brazil)

    2011-10-12

    In this paper we address a theoretical calculation of the electronic spectra of an Si-Ge atomic chain that is arranged in a Fibonacci quasi-periodic sequence, by using a semi-empirical quantum method based on the Hueckel extended model. We apply the Fibonacci substitutional sequences in the atomic building blocks A(Si) and B(Ge) through the inflation rule or a recursion relation. In our ab initio calculations we use only a single point, which is sufficient for considering all the orbitals and charge distribution across the entire system. Although the calculations presented here are more complete than the models adopted in the literature which take into account the electronic interaction only up to the second and third neighbors, an interesting property remains in their electronic spectra: the fractality (which is the main signature of this kind of system). We discuss this fractality of the spectra and we compare them with the random arrangement of the Si-Ge atomic chain, and with previous results based on the tight-binding approximation of the Schroedinger equation considering up to the nearest neighbor. (paper)

  5. Electron avalanche structure determined by random walk theory

    Science.gov (United States)

    Englert, G. W.

    1973-01-01

    A self-consistent avalanche solution which accounts for collective long range Coulomb interactions as well as short range elastic and inelastic collisions between electrons and background atoms is made possible by a random walk technique. Results show that the electric field patterns in the early formation stages of avalanches in helium are close to those obtained from theory based on constant transport coefficients. Regions of maximum and minimum induced electrostatic potential phi are located on the axis of symmetry and within the volume covered by the electron swarm. As formation time continues, however, the region of minimum phi moves to slightly higher radii and the electric field between the extrema becomes somewhat erratic. In the intermediate formation periods the avalanche growth is slightly retarded by the high concentration of ions in the tail which oppose the external electric field. Eventually the formation of ions and electrons in the localized regions of high field strength more than offset this effect causing a very abrupt increase in avalanche growth.

  6. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China.

  7. Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

    Science.gov (United States)

    Ee, Carolyn; Xue, Charlie; Chondros, Patty; Myers, Stephen P; French, Simon D; Teede, Helena; Pirotta, Marie

    2016-02-02

    Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). Community in Australia. Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. National Health and Medical Research Council.

  8. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial.

    Science.gov (United States)

    Tellez, M; Potter, C M; Kinner, D G; Jensen, D; Waldron, E; Heimberg, R G; Myers Virtue, S; Zhao, H; Ismail, A I

    2015-09-01

    Anxiety regarding dental and physical health is a common and potentially distressing problem, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention that could be easily implemented in dental health care settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N = 151) to test its efficacy. Consenting adult dental patients who met inclusion criteria (e.g., high dental anxiety) were randomized to 1 of 2 groups: immediate treatment (n = 74) or a wait-list control (n = 77). Analyses of covariance based on intention-to-treat analyses were used to compare the 2 groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates. Groups were equivalent at baseline but differed at 1-mo follow-up. Both groups showed improvement in outcomes, but analyses of covariance demonstrated significant differences in dental anxiety, fear, avoidance, and overall severity of dental phobia in favor of immediate treatment at the follow-up assessment. Of the patients who met diagnostic criteria for phobia at baseline, fewer patients in the immediate treatment group continued to meet criteria for dental phobia at follow-up as compared with the wait-list group. A new computer-based tool seems to be efficacious in reducing dental anxiety and fear/avoidance of dental procedures. Examination of its effectiveness when administered in dental offices under less controlled conditions is warranted (ClinicalTrials.gov NCT02081365). © International & American Associations for Dental Research.

  9. Laparoscopic Versus Abdominal Sacrocolpopexy: A Randomized, Controlled Trial.

    Science.gov (United States)

    Costantini, Elisabetta; Mearini, Luigi; Lazzeri, Massimo; Bini, Vittorio; Nunzi, Elisabetta; di Biase, Manuel; Porena, Massimo

    2016-07-01

    Few randomized, controlled trials have compared standard abdominal sacrocolpopexy and the laparoscopic approach. We tested the hypothesis that laparoscopic sacrocolpopexy could compete with abdominal sacrocolpopexy for pelvic organ prolapse repair. This randomized, controlled trial was done to compare laparoscopic sacrocolpopexy and abdominal sacrocolpopexy for pelvic organ prolapse repair in women referred to our tertiary Department of Urology for symptomatic stage 2 or greater pelvic organ prolapse. The primary outcome was quantitative evaluation by the POP-Q (Pelvic Organ Prolapse Quantification) system. Cure was defined as prolapse stage 1 or less, point C/D -5 or less at the apex and at least 7 cm total vaginal length. Secondary outcomes were the complication rate, operative time, intraoperative blood loss, hospital stay and PGI-I (Patient Global Impression of Improvement) scores. The Kaplan-Meier estimator with the log-rank test was used to estimate pelvic organ prolapse recurrence-free survival rates. A total of 200 patients were eligible for study. We compared 60 and 61 patients treated with abdominal and laparoscopic sacrocolpopexy, respectively. At a mean followup of 41.7 months the cure rate was of 100% for both approaches. Kaplan-Meier curves showed that overall pelvic organ prolapse recurrence-free survival was longer following the open approach. Patients treated with laparoscopic sacrocolpopexy showed significantly earlier recurrence (p = 0.030), mostly in the first 12 months after surgery. When evaluating the different compartments, a statistically significant difference was observed between the laparoscopic and abdominal approaches for anterior compartment descensus (11 vs 1, p = 0.004). Statistical results had high internal validity but may not be applicable to other populations or settings. Laparoscopic sacrocolpopexy provides outcomes as good as those of abdominal sacrocolpopexy for anatomical correction but not for anterior pelvic organ prolapse

  10. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial.

    Science.gov (United States)

    Fouda, Abdelrahman Y; Newsome, Andrea S; Spellicy, Samantha; Waller, Jennifer L; Zhi, Wenbo; Hess, David C; Ergul, Adviye; Edwards, David J; Fagan, Susan C; Switzer, Jeffrey A

    2017-10-01

    Minocycline is under investigation as a neurovascular protective agent for stroke. This study evaluated the pharmacokinetic, anti-inflammatory, and safety profile of minocycline after intracerebral hemorrhage. This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. Adults ≥18 years with primary intracerebral hemorrhage who could have study drug administered within 24 hours of onset were included. Patients received 400 mg of intravenous minocycline, followed by 400 mg minocycline oral daily for 4 days. Serum concentrations of minocycline after the last oral dose and biomarkers were sampled to determine the peak concentration, half-life, and anti-inflammatory profile. A total of 16 consecutive eligible patients were enrolled, with 8 randomized to minocycline. Although the literature supports a time to peak concentration (Tmax) of 1 hour for oral minocycline, the Tmax was estimated to be at least 6 hours in this cohort. The elimination half-life (available on 7 patients) was 17.5 hours (SD±3.5). No differences were observed in inflammatory biomarkers, hematoma volume, or perihematomal edema. Concentrations remained at neuroprotective levels (>3 mg/L) throughout the dosing interval in 5 of 7 patients. In intracerebral hemorrhage, a 400 mg dose of minocycline was safe and achieved neuroprotective serum concentrations. However, oral administration led to delayed absorption in these critically ill patients and should not be used when rapid, high concentrations are desired. Given the safety and pharmacokinetic profile of minocycline in intracerebral hemorrhage and promising data in the treatment of ischemic stroke, intravenous minocycline is an excellent candidate for a prehospital treatment trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01805895. © 2017 American Heart Association, Inc.

  11. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Antiplatelet treatments: recent evidence from randomized controlled trials.

    Science.gov (United States)

    Vogel, Birgit; Baber, Usman

    2017-07-01

    To provide an overview of selected randomized studies reported over the last 2 years evaluating antiplatelet therapies in patients with either acute or stable manifestations of atherosclerosis. From large outcome trials included evidence for reduced risk of ischemic events associated with use of ticagrelor and aspirin versus aspirin alone, albeit with an increased bleeding risk in patients with stable coronary artery disease and history of myocardial infarction. No benefit regarding ischemic outcomes could be demonstrated for ticagrelor monotherapy compared with aspirin or clopidogrel in patients with stroke or peripheral vascular disease, respectively. Results from pharmacokinetic/pharmacodynamic studies suggest that switching from prasugrel to ticagrelor is safe, regardless of the use of a loading dose, and that loading with prasugrel or ticagrelor compared with clopidogrel leads to more prompt and potent platelet inhibition in patients undergoing ad hoc percoutaneous coronary intervention. No evidence could be demonstrated for the prognostic value of routine platelet function monitoring to adjust antiplatelet therapy. Large outcome trials demonstrated various effects of antithrombotic strategies including ticagrelor on clinical outcomes across patient populations. Pharmacokinetic/pharmacodynamic studies confirmed a more prompt and potent platelet inhibition after loading with the new P2Y12 inhibitors versus clopidogrel, and suggested the safety of switching from prasugrel to ticagrelor.

  13. Randomized trial of behavior therapy for adults with Tourette syndrome.

    Science.gov (United States)

    Wilhelm, Sabine; Peterson, Alan L; Piacentini, John; Woods, Douglas W; Deckersbach, Thilo; Sukhodolsky, Denis G; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T; Scahill, Lawrence

    2012-08-01

    Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decrease by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. A randomized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Three outpatient research clinics. Patients (N = 122; 78 males; age range, 16-69 years) with Tourette syndrome or chronic tic disorder were recruited between December 27, 2005, and May 21, 2009. Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks. Patients with a positive response were given 3 monthly booster sessions. Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment. Behavior therapy was associated with a significantly greater mean (SD) decrease on the Yale Global Tic Severity Scale (24.0 [6.47] to 17.8 [7.32]) from baseline to end point compared with the control treatment (21.8 [6.59] to 19.3 [7.40]) (P Tourette syndrome. clinicaltrials.gov Identifier: NCT00231985.

  14. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Ppsychomotricity a safe and efficacy therapy for pediatric selective mutism.

  15. Quality of reporting randomized controlled trials in cancer nursing research.

    Science.gov (United States)

    Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy

    2014-01-01

    Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.

  16. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

    Science.gov (United States)

    Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan

    2007-07-26

    Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

  17. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    Science.gov (United States)

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  18. Geographic Information Systems to Assess External Validity in Randomized Trials.

    Science.gov (United States)

    Savoca, Margaret R; Ludwig, David A; Jones, Stedman T; Jason Clodfelter, K; Sloop, Joseph B; Bollhalter, Linda Y; Bertoni, Alain G

    2017-08-01

    To support claims that RCTs can reduce health disparities (i.e., are translational), it is imperative that methodologies exist to evaluate the tenability of external validity in RCTs when probabilistic sampling of participants is not employed. Typically, attempts at establishing post hoc external validity are limited to a few comparisons across convenience variables, which must be available in both sample and population. A Type 2 diabetes RCT was used as an example of a method that uses a geographic information system to assess external validity in the absence of a priori probabilistic community-wide diabetes risk sampling strategy. A geographic information system, 2009-2013 county death certificate records, and 2013-2014 electronic medical records were used to identify community-wide diabetes prevalence. Color-coded diabetes density maps provided visual representation of these densities. Chi-square goodness of fit statistic/analysis tested the degree to which distribution of RCT participants varied across density classes compared to what would be expected, given simple random sampling of the county population. Analyses were conducted in 2016. Diabetes prevalence areas as represented by death certificate and electronic medical records were distributed similarly. The simple random sample model was not a good fit for death certificate record (chi-square, 17.63; p=0.0001) and electronic medical record data (chi-square, 28.92; p<0.0001). Generally, RCT participants were oversampled in high-diabetes density areas. Location is a highly reliable "principal variable" associated with health disparities. It serves as a directly measurable proxy for high-risk underserved communities, thus offering an effective and practical approach for examining external validity of RCTs. Copyright © 2017 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  19. Online psychoeducational support for infertile women: a randomized controlled trial

    Science.gov (United States)

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  20. Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

    Science.gov (United States)

    Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

    2018-01-22

    Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

  1. A randomized controlled trial of home tooth-whitening products.

    Science.gov (United States)

    Lo, Edward C M; Wong, Anthony H H; McGrath, Colman

    2007-10-01

    To evaluate the effectiveness of two marketed home tooth-whitening products. A randomized controlled clinical trial involving 87 adults who were randomly allocated into one of three groups: (1) 6% hydrogen peroxide whitening strips, (2) 18% carbamide peroxide whitening gel, and (3) a placebo (fluoride toothpaste) control group. Subjects were instructed individually and then used the given product daily for 2 consecutive weeks. Color was determined in brightness (L*), yellowness (b*) and redness (a*) [color space] at baseline and 8 weeks after dispensing the product by employing a high resolution digital camera (Fuji HC1000 CCD) to image the subject's anterior maxillary teeth under standard polarized lighting conditions. The subjects also completed a questionnaire on self-satisfaction with the treatment outcome. One-way ANOVA (Bonferroni test) demonstrated significant differences in color between the three groups with changes in brightness (L*, Pwhitening strips. Subjects in the whitening strip group also rated that product significantly (P whitening satisfaction and overall impression while there is no significant difference between the whitening gel and the placebo groups.

  2. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  3. Effects of professional oral health care on elderly: randomized trial.

    Science.gov (United States)

    Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

    2014-11-01

    To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Rehabilitation programme after stem cell transplantation: randomized controlled trial.

    Science.gov (United States)

    Bird, Lydia; Arthur, Antony; Niblock, Tara; Stone, Rebecca; Watson, Lynn; Cox, Karen

    2010-03-01

    The aim of this study was to compare the effect of two methods of rehabilitation after stem cell transplantation on health and quality of life. Stem cell transplantation is routinely used in the treatment of haematological malignancy. However, it is an intensive treatment often associated with deterioration in wellbeing and the need for prolonged recovery. During a 14-month data collection period (August 2005 to October 2006), patients who had had a stem cell transplant (n = 58) were randomly allocated to either a healthcare professional-led rehabilitation programme or a self-managed rehabilitation programme. The primary outcome measure, physical functioning as measured by the 36-item Short Form Health Survey, was recorded at baseline and 6 months after randomization. Secondary health and quality of life measures included the seven other dimensions of the 36-item Short Form Health Survey, General Health Questionnaire, Graham and Longman Quality of Life Scale and a Shuttle Walk Test. There was no difference in change in Short Form 36 physical functioning scores between the two groups at follow-up (mean difference 0.19 points, 95% confidence interval 10.77-11.16). No evidence of a difference between the two modes of rehabilitation was observed for any of the trial outcomes. One approach for providing a flexible service may be for staff and individual patients to work together, selecting from a series of specified options a programme with the appropriate content and duration to meet that individual's needs.

  5. Metoclopramide to augment lactation, does it work? A randomized trial.

    Science.gov (United States)

    Fife, Shannon; Gill, Prabhcharan; Hopkins, Michael; Angello, Carol; Boswell, Sue; Nelson, Karl M

    2011-11-01

    The objective of this study was to investigate the efficacy of metoclopramide on augmentation of milk production in mothers of premature newborns. This was a randomized, double-blind, placebo-controlled trial. Women who delivered at ≤34 weeks of gestation, with no prior breastfeeding experience, singleton pregnancy, and no contraindications to using metoclopramide were eligible for entry. Twenty-five women were randomly assigned to receive 10 mg of metoclopramide or placebo three times daily for 8 days starting within 36 h of birth. Certified lactation nurses provided breastfeeding education. Breast milk expressed at each pumping session over the 8 days of treatment was recorded. Data from 18 patients were available for analysis. Milk production in both groups increased rapidly during the first 4 days and then more gradually to an average for the last 4 days of 633 ± 168 (9) ml/day [mean ± SEM (n)] for the placebo group and 459 ± 91 (10) ml/day for the metoclopramide group. Analysis with a repeated-measures ANOVA indicated a significant increase in milk production during the 8-day measurement period [within subjects p power for detection of 50% difference) the breast milk production. Maternal interest, education, and support are recognized as mainstay in accomplishing successful lactation.

  6. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  7. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  8. Randomized trial of aromatherapy. Successful treatment for alopecia areata.

    Science.gov (United States)

    Hay, I C; Jamieson, M; Ormerod, A D

    1998-11-01

    To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.

  9. Resin infiltration of caries lesions: an efficacy randomized trial.

    Science.gov (United States)

    Paris, S; Hopfenmuller, W; Meyer-Lueckel, H

    2010-08-01

    Resin infiltration is an innovative approach to arrest progression of caries lesions. The aim of this randomized split-mouth placebo-controlled clinical trial was to assess whether resin infiltration of proximal lesions is more effective than non-operative measures alone with respect to the inhibition of caries progression. In 22 young adults, 29 pairs of interproximal lesions with radiological extension into the inner half of enamel or the outer third of dentin were randomly allocated to two treatment groups. In the test group, lesions were infiltrated (Icon, pre-product; DMG). A placebo treatment was performed in the control group. All participants received instructions for diet, flossing, and fluoridation. The primary outcome after 18 months was radiographic lesion progression (assessed by digital subtraction radiography). No unwanted effects could be observed. In the effect group, 2/27 lesions (7%) and in the control group 10/27 lesions (37%) showed progression (p = 0.021; McNemar). Infiltration of interproximal caries lesions is efficacious in reducing lesion progression.

  10. Dry cupping for plantar fasciitis: a randomized controlled trial

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested. PMID:28603360

  11. Design Issues in Randomized Clinical Trials of Maintenance Therapies.

    Science.gov (United States)

    Freidlin, Boris; Little, Richard F; Korn, Edward L

    2015-11-01

    A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-duration induction therapy is to receive maintenance therapy, typically given for a prolonged period of time. To enable patients and clinicians to make informed treatment decisions, the designs of phase III randomized clinical trials (RCTs) assessing maintenance strategies need to be such that their results will provide clear assessment of the relevant risks and benefits of these strategies. We review the key aspects of maintenance RCT designs. Important design considerations include choice of first-line and second-line therapies, minimizing between-arm differences in follow-up schedules, and choice of the primary endpoint. In order to change clinical practice, RCTs should be designed to accurately isolate and quantify the clinical benefit of maintenance as compared with the standard approach of fixed-duration induction followed by the second-line treatment at progression. To accomplish this, RCTs need to utilize an overall survival (or quality of life) endpoint or, in settings where this is not feasible, endpoints that incorporate the effects of the subsequent line of therapy (eg, time from randomization to second progression or death). Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  12. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    Science.gov (United States)

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  13. Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010.

    Science.gov (United States)

    Reveiz, Ludovic; Bonfill, Xavier; Glujovsky, Demian; Pinzon, Carlos E; Asenjo-Lobos, Claudia; Cortes, Marcela; Canon, Martin; Bardach, Ariel; Comandé, Daniel; Cardona, Andrés F

    2012-05-01

    To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs. A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n=89) and in a sample of nonregistered RCTs (n=237). The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs. This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  15. Screening for obstructive sleep apnea on the internet: randomized trial.

    Science.gov (United States)

    Hwang, Kevin O; Hamadah, Abdurrahman M; Johnson, Craig W; Thomas, Eric J; Goodrick, G Ken; Bernstam, Elmer V

    2009-10-01

    Obstructive sleep apnea is underdiagnosed. We conducted a pilot randomized controlled trial of an online intervention to promote obstructive sleep apnea screening among members of an Internet weight-loss community. Members of an Internet weight-loss community who have never been diagnosed with obstructive sleep apnea or discussed the condition with their healthcare provider were randomized to intervention (online risk assessment+feedback) or control. The primary outcome was discussing obstructive sleep apnea with a healthcare provider at 12 weeks. Of 4700 members who were sent e-mail study announcements, 168 (97% were female, age 39.5 years [standard deviation 11.7], body mass index 30.3 [standard deviation 7.8]) were randomized to intervention (n=84) or control (n=84). Of 82 intervention subjects who completed the risk assessment, 50 (61%) were low risk and 32 (39%) were high risk for obstructive sleep apnea. Intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider within 12 weeks (11% [9/84] vs 2% [2/84]; P=.02; relative risk=4.50; 95% confidence interval, 1.002-20.21). The number needed to treat was 12. High-risk intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider (19% [6/32] vs 2% [2/84]; P=.004; relative risk=7.88; 95% confidence interval, 1.68-37.02). One high-risk intervention subject started treatment for obstructive sleep apnea. An online screening intervention is feasible and likely effective in encouraging members of an Internet weight-loss community to discuss obstructive sleep apnea with their healthcare provider.

  16. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  17. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  18. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC).

    Science.gov (United States)

    Andrade, Luis Angel Medina; Muñoz, Franz Yeudiel Pérez; Báez, María Valeria Jiménez; Collazos, Stephanie Serrano; de Los Angeles Martinez Ferretiz, Maria; Ruiz, Brenda; Montes, Oscar; Woolf, Stephanie; Noriega, Jessica Gonzalez; Aparicio, Uriel Maldonado; Gonzalez, Israel Gonzalez

    2016-11-01

    Appendectomy is the most frequent and urgent gastrointestinal surgery. Overtime, the surgical techniques have been improved upon, in order to reduce complications, get better cosmetic results, and limit the discomfort associated with this procedure, by its high impact in the surgery departments. The traditional skin closure is associated with a poor cosmetic result and it requires stitches removal, alongside the pain associated with this procedure, and no benefits were demonstrated in the literature regarding separated stitches over intradermic stitch. This is a randomized controlled trial, and our objective is to compare two different skin closure techniques in open appendectomy. A prospective randomized trial method was used, with a total number of 208 patients participating in the study, after acute appendicitis diagnosis in the emergency department. They were randomized into two groups: patients who would receive skin closure with a unique absorbable intradermic stitch (Group A) and another group that would receive the traditional closure technique, consistent in non-absorbable separated stitches (Group B). General characteristics like gender, age, Body Mass Index (BMI), comorbidities, and allergies were registered. Days of Evolution (DOE) until surgery, previous use of antibiotics, complicated or uncomplicated appendicitis, surgical time, and wound complications like skin infection, dehiscence, seroma or abscess were also registered in each case. 8 patients were excluded due to negative appendicitis during surgery and lack of follow-up. Two groups, each containing 100 patients, were formed. General characteristics and parity were compared, and no statistically significant differences were observed. Difference in the surgical time (Group A: 47.35 min vs Group B: 54.13 min, p  25 kg/m2 and seroma (p = .006), BMI > 25 kg/m2 and abscess (p = .02), surgical time >50 min and seroma (p 2 DOE and abscess (p = .001), and complicated appendicitis with

  19. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  20. Bayesian adaptive randomization in a clinical trial to identify new regimens for MDR-TB: the endTB trial.

    Science.gov (United States)

    Cellamare, M; Milstein, M; Ventz, S; Baudin, E; Trippa, L; Mitnick, C D

    2016-12-01

    Evidence-based optimization of treatment for multidrug-resistant tuberculosis (MDR-TB), including integration of new drugs, is urgent. Such optimization would benefit from efficient trial designs requiring fewer patients. Implementation of such innovative designs could accelerate improvements in and access to MDR-TB treatment. To describe the application, advantages, and challenges of Bayesian adaptive randomization in a Phase III non-inferiority trial of MDR-TB treatment. endTB is the first Phase III non-inferiority trial of MDR-TB treatment to use Bayesian adaptive randomization. We present a simulation study with assumptions for treatment response at 8, 39, and 73 weeks after randomization, on which sample size calculations are based. We show differences between Bayesian adaptive randomization and balanced randomization designs in sample size and number of patients exposed to ineffective regimens. With 750 participants, 27% fewer than required by balanced randomization, the study had 80% power to detect up to two (of five) novel treatment regimens that are non-inferior (margin 12%) to the control (70% estimated efficacy) at 73 weeks post randomization. Comparing Bayesian adaptive randomization to balanced randomization, up to 25% more participants would receive non-inferior regimens. Bayesian adaptive randomization may expose fewer participants to ineffective treatments and enhance the efficiency of MDR-TB treatment trials.

  1. Hip-Hop to Health Jr. Randomized Effectiveness Trial

    Science.gov (United States)

    Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.

    2015-01-01

    Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively

  2. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS trial: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wu Samuel S

    2007-11-01

    Full Text Available Abstract Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP, conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a LTP-Early; (b LTP-Late or (c Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and

  3. Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ridd, Matthew J; Redmond, Niamh M; Hollinghurst, Sandra; Ball, Nicola; Shaw, Lindsay; Guy, Richard; Wilson, Victoria; Metcalfe, Chris; Purdy, Sarah

    2015-07-15

    Eczema is common in children and in the UK most cases are managed in primary care. The foundation of all treatment is the regular use of leave-on emollients to preserve and restore moisture to the skin. This not only improves comfort but may also reduce the need for rescue treatment for 'flares', such as topical corticosteroids. However, clinicians can prescribe many different types of emollient and there is a paucity of evidence to guide this choice. One reason for this may be the challenges of conducting a clinical trial: are parents or carers of young children willing to be randomly allocated an emollient and followed up for a meaningful amount of time? This is a single-centre feasibility study of a pragmatic, four-arm, single-masked, randomized trial. Children with eczema who are eligible (from 1 month to less than 5 years of age, not known to be sensitive or allergic to any of study emollients or their constituents) are recruited via their general practices. Participants are allocated Aveeno® lotion, Diprobase® cream, Doublebase® gel or Hydromol® ointment via a web-based system, using a simple randomization process in a 1:1:1:1 fashion. Researchers are masked to the study emollient. Participants are assessed at baseline and followed up for 3 months. Data are collected by daily diaries, monthly researcher visits and review of electronic medical records. Because this is a feasibility study, a formal sample size calculation for the estimation of treatment effectiveness has not be made but we aim to recruit 160 participants. Recruitment is on-going. At the end of the study, as well as being able to answer the question, 'Is it is possible to recruit and retain children with eczema from primary care into a four-arm randomized trial of emollients?', we will also have collected important data on the acceptability and effectiveness of four commonly used emollients. Current Controlled Trials ISRCTN21828118 and Clinical Trials Register EudraCT2013-003001-26.

  4. Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials

    OpenAIRE

    Ewald, H; Kirby, J.; Rees, K; W. Robertson

    2017-01-01

    Background An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. Methods A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. Inclusion criteria: randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child,...

  5. The Effectiveness of Physiotherapy and Complementary Therapies on Voice Disorders: A Systematic Review of Randomized Controlled Trials

    OpenAIRE

    Cardoso, Ricardo; Meneses,Rute F.; Lumini-Oliveira, José

    2017-01-01

    The treatment of voice disorders includes physiotherapy and complementary therapies. However, research to support these treatments is scarce. Objective: to verify the effectiveness of physiotherapy and complementary therapies on voice disorders. Research on electronic databases PubMed/Medline, SciELO, and LILACS was performed using the combination: voice AND (treatment OR intervention) according to PRISMA guidelines. Only randomized controlled trials (RCTs) were included in the review. Studie...

  6. Effects of preventive online mindfulness interventions on stress and mindfulness: A meta-analysis of randomized controlled trials

    OpenAIRE

    Jayewardene, Wasantha P.; Lohrmann, David K.; Erbe, Ryan G.; Torabi, Mohammad R.

    2016-01-01

    Empirical evidence suggested that mind-body interventions can be effectively delivered online. This study aimed to examine whether preventive online mindfulness interventions (POMI) for non-clinical populations improve short- and long-term outcomes for perceived-stress (primary) and mindfulness (secondary). Systematic search of four electronic databases, manuscript reference lists, and journal content lists was conducted in 2016, using 21 search-terms. Eight randomized controlled trials (RCTs...

  7. Safety of oral use of nimesulide in children: systematic review of randomized controlled trials.

    Science.gov (United States)

    Gupta, Piyush; Sachdev, H P S

    2003-06-01

    Nimesulide has been widely used to treat fever in children. Due to reports of adverse drug reactions, discontinuation or modification of its use has been suggested. To evaluate the safety of oral use of nimesulide in children. Systematic review of published randomized controlled trials. Electronic searches of databases (PubMed, Cochrane, Toxnet) for relevant trials upto January 2003 using specified key words. The studies were also identified by searching the references of available meta-analyses and review articles, and bibliography of pertinent references. Randomized controlled trials in children (less than or equal to 18 years of age) comparing the use of oral nimesulide with placebo or other antipyretic, anti-inflammatory or analgesic agents. The primary outcome variable included the commonly encountered adverse effects of nimesulide therapy, i.e., hypothermia, abdominal symptoms, gastrointestinal bleeding, and elevated liver enzymes. One of the authors developed a questionnaire and independently extracted data on methods, type of participants, interventions and outcomes. The meta-analysis was conducted using pooled relative risk with 95% confidence intervals, with random effects model assumption. We identified 16 trials that fulfilled the inclusion criteria. These included 1254 subjects, with mean age between 22 -140 months. Nimesulide was primarily used for its antipyretic (10 trials) or anti-inflammatory and analgesic activity (4 trials). One study each evaluated the symptomatic improvement in ARI and bronchial asthma. The control group included administration of placebo (3 studies), paracetamol (9 studies), and ketoprofen, naproxen, mefanemic acid and aspirin in one study each. The pooled effect sizes of various adverse events as compared between nimesulide and different control groups were: hypothermia (RR: 1.055; 95% CI: 0.184 - 6.047; P = 0.952), abdominal symptoms (RR: 0.464; 95% CI: 0.264 - 0.816; P = 0.008), gastrointestinal bleeding (RR: 0.914; 95% CI

  8. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  9. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  10. The impact of data errors on the outcome of randomized clinical trials

    NARCIS (Netherlands)

    Buyse, Marc; Squifflet, Pierre; Coart, Elisabeth; Quinaux, Emmanuel; Punt, Cornelis J. A.; Saad, Everardo D.

    2017-01-01

    Background/aims: Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods: We used individual patient data

  11. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  12. Is the randomized controlled drug trial in Europe lagging behind the USA?

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? center dot The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. center dot Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and

  13. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  14. Review of randomized controlled trials of nutritional supplementation in people living with HIV

    Directory of Open Access Journals (Sweden)

    Sneij A

    2016-04-01

    Full Text Available Alicia Sneij, Adriana Campa, Marianna K Baum Stempel College of Public Health and Social Work, Florida International University, Modesto Maidique Campus, Miami, FL, USA Background: Nutritional deficiencies are widespread in people living with HIV (PLWH, prior to the antiretroviral treatment (ART. Nutrient deficiencies and other nutrition-related conditions, however, have been identified in patients receiving ART. Trials of nutritional supplementation have been conducted to alleviate these nutritional conditions and improve or reverse nutrition-related outcomes. This review aims to evaluate the benefits of supplementation, its unintended adverse effects, and the difference in approach and focus, research design, formulations, and outcomes between those randomized clinical trials (RCTs conducted before and after the initiation of ART. Methods: An evidence-based systematic review of the literature was conducted using electronic databases and the resources of the Florida International University Research Library. Forty-two RCTs were selected for review, and their design and outcomes were compared and contrasted conceptually and in the form of tables. Results: Most of the RCTs (n=31 were conducted before the advent of ART, and their aims were delaying disease progression, reversing malnutrition, and improving pregnancy outcomes in women and infants infected with HIV. The RCTs conducted with coadministration of ART were fewer (n=11, with relative smaller sample size, of shorter duration, and mainly focused on preventing or ameliorating the nutrition-related conditions generated by the chronic infection, its treatment, and the aging of PLWH. Conclusion: As ART is becoming more accessible worldwide, and people are living longer with the disease, more longitudinal trials of nutritional interventions with larger sample sizes are needed to study the nutritional consequences and potential treatments for PLWH. Keywords: HIV, antiretroviral therapy

  15. Mortality in the Randomized, Controlled Lung Intergroup Trial of Isotretinoin

    Science.gov (United States)

    Lee, J. Jack; Feng, Lei; Reshef, Daniel S.; Sabichi, Anita L.; Williams, Brendell; Rinsurongkawong, Waree; Wistuba, Ignacio I.; Lotan, Reuben; Lippman, Scott M.

    2010-01-01

    In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial (LIT). Now, we report the overall and cause (cancer, cardiovascular disease, or other)-specific mortality associated with long-term isotretinoin after an extended median follow-up of 6.2 years that included the capture of cause-of-death data from 428 deceased patients. Overall mortality was 36.7% in each of the two trial arms, about two-thirds related to cancer, one-third to other or unknown causes. Overall and cancer deaths increased in current smokers in the isotretinoin arm during the treatment and the extended follow-up period. No mortality endpoint increased among never smokers and former smokers taking isotretinoin, and cancer deaths decreased marginally in this combined subgroup. Isotretinoin also increased deaths from cardiovascular disease in current smokers. The present analysis supports the safety of protracted isotretinoin use in the combined group of never smokers and former smokers, which has important public health implications, e.g., for treating acne in young people. The increased mortality in current smokers in this study is further evidence of the multifaceted danger of active smoking. The overall indications of this study have public health implications for treating acne in young people and other uses of retinoids in smokers. PMID:20501862

  16. A randomized trial of prenatal versus postnatal repair of myelomeningocele.

    Science.gov (United States)

    Adzick, N Scott; Thom, Elizabeth A; Spong, Catherine Y; Brock, John W; Burrows, Pamela K; Johnson, Mark P; Howell, Lori J; Farrell, Jody A; Dabrowiak, Mary E; Sutton, Leslie N; Gupta, Nalin; Tulipan, Noel B; D'Alton, Mary E; Farmer, Diana L

    2011-03-17

    Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair. We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function. The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery. Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).

  17. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial.

    Science.gov (United States)

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

    There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer's disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. ClinicalTrials.gov NCT01128361.

  18. Randomized trial of oral teriflunomide for relapsing multiple sclerosis.

    Science.gov (United States)

    O'Connor, Paul; Wolinsky, Jerry S; Confavreux, Christian; Comi, Giancarlo; Kappos, Ludwig; Olsson, Tomas P; Benzerdjeb, Hadj; Truffinet, Philippe; Wang, Lin; Miller, Aaron; Freedman, Mark S

    2011-10-06

    Teriflunomide is a new oral disease-modifying therapy for relapsing forms of multiple sclerosis. We concluded a randomized trial involving 1088 patients with multiple sclerosis, 18 to 55 years of age, with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least one relapse in the previous year or at least two relapses in the previous 2 years. Patients were randomly assigned (in a 1:1:1 ratio) to placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (Pteriflunomide at 7 mg (P=0.08), and 20.2% with teriflunomide at 14 mg (P=0.03). Both teriflunomide doses were superior to placebo on a range of end points measured by magnetic resonance imaging (MRI). Diarrhea, nausea, and hair thinning were more common with teriflunomide than with placebo. The incidence of elevated alanine aminotransferase levels (≥1 times the upper limit of the normal range) was higher with teriflunomide at 7 mg and 14 mg (54.0% and 57.3%, respectively) than with placebo (35.9%); the incidence of levels that were at least 3 times the upper limit of the normal range was similar in the lower- and higher-dose teriflunomide groups and the placebo group (6.3%, 6.7%, and 6.7%, respectively). Serious infections were reported in 1.6%, 2.5%, and 2.2% of patients in the three groups, respectively. No deaths occurred. Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo. (Funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563.).

  19. Caffeine for treatment of Parkinson disease: a randomized controlled trial.

    Science.gov (United States)

    Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit

    2012-08-14

    Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime

  20. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-01-01

    randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS: Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8...

  1. Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial

    Directory of Open Access Journals (Sweden)

    de Lange Elly SM

    2011-01-01

    Full Text Available Abstract Background There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery. Methods/Design Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor, quality of life tests and hospital stay. Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm

  2. Randomized controlled trial of a lay-facilitated angina management programme

    OpenAIRE

    Furze, Gill; Cox, Helen; Morton, Veronica; Chuang, Ling-Hsiang; Lewin, Robert JP; Nelson, Pauline; Carty, Richard; Norris, Heather; Patel, Nicky; Elton, Peter

    2012-01-01

    Aims This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). Background Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. Design A randomized controlled trial comparing a lay-facilita...

  3. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial.

    Science.gov (United States)

    Afonso, Rui Ferreira; Hachul, Helena; Kozasa, Elisa Harumi; Oliveira, Denise de Souza; Goto, Viviane; Rodrigues, Dinah; Tufik, Sérgio; Leite, José Roberto

    2012-02-01

    The practice of yoga has been proven to have positive effects on reducing insomnia. Studies have also shown its effects on reducing climacteric symptoms. To date, however, no studies that evaluate the effects of yoga on postmenopausal women with a diagnosis of insomnia in a randomized clinical trial have been conducted. The aim of this study was to evaluate the effect of yoga practice on the physical and mental health and climacteric symptoms of postmenopausal women with a diagnosis of insomnia. Postmenopausal women not undergoing hormone therapy, who were 50 to 65 years old, who had an apnea-hypopnea index less than 15, and who had a diagnosis of insomnia were randomly assigned to one of three groups, as follows: control, passive stretching, and yoga. Questionnaires were administered before and 4 months after the intervention to evaluate quality of life, anxiety and depression symptoms, climacteric symptoms, insomnia severity, daytime sleepiness, and stress. The volunteers also underwent polysomnography. The study lasted 4 months. There were 44 volunteers at the end of the study. When compared with the control group, the yoga group had significantly lower posttreatment scores for climacteric symptoms and insomnia severity and higher scores for quality of life and resistance phase of stress. The reduction in insomnia severity in the yoga group was significantly higher than that in the control and passive-stretching groups. This study showed that a specific sequence of yoga might be effective in reducing insomnia and menopausal symptoms as well as improving quality of life in postmenopausal women with insomnia.

  4. Promoting healthy weight with "stability skills first": a randomized trial.

    Science.gov (United States)

    Kiernan, Michaela; Brown, Susan D; Schoffman, Danielle E; Lee, Katherine; King, Abby C; Taylor, C Barr; Schleicher, Nina C; Perri, Michael G

    2013-04-01

    Although behavioral weight-loss interventions produce short-term weight loss, long-term maintenance remains elusive. This randomized trial examined whether learning a novel set of "stability skills" before losing weight improved long-term weight management. Stability skills were designed to optimize individuals' current satisfaction with lifestyle and self-regulatory habits while requiring the minimum effort and attention necessary. Overweight/obese women (N = 267) were randomly assigned to one of two 6-month interventions and assessed at baseline and at 6, 12, and 18 months. Maintenance First women participated first in an 8-week stability skills maintenance module and then in a standard 20-week behavioral weight-loss program. Weight Loss First women participated first in a standard 20-week behavioral weight-loss program and then in a standard 8-week problem-solving skills maintenance module. There was no intervention staff contact during the 12-month follow-up period (6-18 months). As designed, Maintenance First participants lost the same percentage of initial weight during the 6-month intervention period as Weight Loss First participants (M = -8.6%, SD = 5.7, vs. M = -9.1%, SD = 6.9; t = -0.6, p = .52). However, Maintenance First participants regained significantly less weight during the 12-month follow-up period (6-18 months) than Weight Loss First participants (M = 3.2 lb, SD = 10.4, vs. M = 7.3 lb, SD = 9.9 [M = 1.4 kg, SD = 4.7, vs. M = 3.3 kg, SD = 4.5]; t = 3.3, p = .001, d = 0.4). Learning stability skills before losing weight was successful in helping women to maintain weight loss without intervention staff contact during follow-up. These results can inform the study design of future innovative interventions.

  5. Aromatherapy as treatment for postoperative nausea: a randomized trial.

    Science.gov (United States)

    Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George

    2013-09-01

    Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.

  6. Preventing alcohol-exposed pregnancies: a randomized controlled trial.

    Science.gov (United States)

    Floyd, R Louise; Sobell, Mark; Velasquez, Mary M; Ingersoll, Karen; Nettleman, Mary; Sobell, Linda; Mullen, Patricia Dolan; Ceperich, Sherry; von Sternberg, Kirk; Bolton, Burt; Johnson, Kenneth; Skarpness, Bradley; Nagaraja, Jyothi

    2007-01-01

    Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. A brief motivational intervention can reduce the risk of an AEP.

  7. School-Located Influenza Vaccinations: A Randomized Trial.

    Science.gov (United States)

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

    2016-11-01

    Assess impact of offering school-located influenza vaccination (SLIV) clinics using both Web-based and paper consent upon overall influenza vaccination rates among elementary school children. We conducted a cluster-randomized trial (stratified by suburban/urban districts) in upstate New York in 2014-2015. We randomized 44 elementary schools, selected similar pairs of schools within districts, and allocated schools to SLIV versus usual care (control). Parents of children at SLIV schools were sent information and vaccination consent forms via e-mail, backpack fliers, or both (depending on school preferences) regarding school vaccine clinics. Health department nurses conducted vaccine clinics and billed insurers. For all children registered at SLIV/control schools, we compared receipt of influenza vaccination anywhere (primary outcome). The 44 schools served 19 776 eligible children in 2014-2015. Children in SLIV schools had higher influenza vaccination rates than children in control schools county-wide (54.1% vs 47.4%, P vaccination in previous season) confirmed bivariate findings. Among parents who consented for SLIV, nearly half of those notified by backpack fliers and four-fifths of those notified by e-mail consented online. In suburban districts, SLIV did not substitute for primary care influenza vaccination. In urban schools, some substitution occurred. SLIV raised seasonal influenza vaccination rates county-wide and in both suburban and urban settings. SLIV did not substitute for primary care vaccinations in suburban settings where pediatricians often preorder influenza vaccine but did substitute somewhat in urban settings. Copyright © 2016 by the American Academy of Pediatrics.

  8. Nutritional vitamin D supplementation in dialysis: a randomized trial.

    Science.gov (United States)

    Bhan, Ishir; Dobens, Dorothy; Tamez, Hector; Deferio, Joseph J; Li, Yan Chun; Warren, H Shaw; Ankers, Elizabeth; Wenger, Julia; Tucker, J Kevin; Trottier, Caitlin; Pathan, Fridosh; Kalim, Sahir; Nigwekar, Sagar U; Thadhani, Ravi

    2015-04-07

    Vitamin D (25-hydroxyvitamin D; 25[OH]D) deficiency is common in patients initiating long-term hemodialysis, but the safety and efficacy of nutritional vitamin D supplementation in this population remain uncertain. This randomized, placebo-controlled, parallel-group multicenter trial compared two doses of ergocalciferol with placebo between October 2009 and March 2013. Hemodialysis patients (n=105) with 25(OH)D levels ≤32 ng/ml from 32 centers in the Northeast United States were randomly assigned to oral ergocalciferol, 50,000 IU weekly (n=36) or monthly (n=33), or placebo (n=36) for a 12-week treatment period. The primary endpoint was the achievement of vitamin D sufficiency (25[OH]D >32 ng/ml) at the end of the 12-week treatment period. Survival was assessed through 1 year. Baseline characteristics were similar across all arms, with overall mean±SD 25(OH)D levels of 21.9±6.9 ng/ml. At 12 weeks, vitamin D sufficiency (25[OH]D >32 ng/ml) was achieved in 91% (weekly), 66% (monthly), and 35% (placebo) (Pvitamin D treatment did not differ between groups. All-cause and cause-specific hospitalizations and adverse events were similar between groups during the intervention period. Lower all-cause mortality among ergocalciferol-treated participants was not statistically significant (hazard ratio, 0.28; 95% confidence interval, 0.07 to 1.19). Oral ergocalciferol can increase 25(OH)D levels in incident hemodialysis patients without significant alterations in blood calcium, phosphate, or parathyroid hormone during a 12-week period. Copyright © 2015 by the American Society of Nephrology.

  9. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    Science.gov (United States)

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p 70%) compared with most published results with multifocal spectacles. Further studies are warranted to identify the critical factors and mechanisms underlying this myopia control effect.

  10. Computerized tailored physical activity reports. A randomized controlled trial.

    Science.gov (United States)

    Carroll, Jennifer K; Lewis, Beth A; Marcus, Bess H; Lehman, Erik B; Shaffer, Michele L; Sciamanna, Christopher N

    2010-08-01

    Computerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. This study examined the effect of computerized tailored physical activity reports on primary care patients' physical activity at 6 months. Two-group randomized clinical trial with physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment. Primary care physicians (n=22) and their adult patients (n=394) from Philadelphia PA. The study and analyses were conducted from 2004 to 2010. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. Minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. Participants were 69% female, 59% African-American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, there were no differences in physical activity at 6 months. The intervention group increased their total physical activity by a mean of 139 minutes; the control group had a mean increase of 109 minutes (p=0.45). Although physical activity increased within both groups, computerized tailored physical activity reports did not significantly increase physical activity between groups at 6 months among ethnically and socioeconomically diverse adults in primary care. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  11. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

  12. A randomized controlled trial of mindfulness meditation for chronic insomnia.

    Science.gov (United States)

    Ong, Jason C; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K

    2014-09-01

    To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial. Academic medical center. Fifty-four adults with chronic insomnia. Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781. © 2014 Associated Professional Sleep Societies, LLC.

  13. Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial.

    Science.gov (United States)

    Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

    2015-05-01

    One of the strategies for a good outcome and pain free childbearing is to design the delivery room. The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants' intervention vs. 66% of control participants had perinea laceration (P = 0.041). According to the findings of the present study, distracting senses in snoezelen room decreases mother's pain intensity, the length of labor, and incidence of episiotomy.

  14. Review of the randomized clinical stroke rehabilitation trials in 2009

    Science.gov (United States)

    Rabadi, Meheroz H.

    2011-01-01

    Summary Background Recent review of the available evidence on interventions for motor recovery after stroke, showed that improvements in recovery of arm function were seen for constraint-induced movement therapy, electromyographic biofeedback, mental practice with motor imagery, and robotics. Similar improvement in transfer ability or balance were seen with repetitive task training, biofeedback, and training with a moving platform. Walking speed was improved by physical fitness training, high-intensity physiotherapy and repetitive task training. However, most of these trials were small and had design limitations. Material/Methods In this article, randomized control trials (RCT’s) published in 2009 of rehabilitation therapies for acute (≤2 weeks), sub-acute (2 to 12 weeks) and chronic (≥12 weeks) stroke was reviewed. A Medline search was performed to identify all RCT’s in stroke rehabilitation in the year 2009. The search strategy that was used for PubMed is presented in the Appendix 1. The objective was to examine the effectiveness of these treatment modalities in stroke rehabilitation. Results This generated 35 RCT’s under 5 categories which were found and analyzed. The methodological quality was assessed by using the PEDro scale for external and internal validity. Conclusions These trials were primarily efficacy studies. Most of these studies enrolled small numbers of patient which precluded their clinical applicability (limited external validity). However, the constraint induced movement therapy (CIT), regularly used in chronic stroke patients did not improve affected arm-hand function when used in acute stroke patients at ≤4 weeks. Intensive CIT did not lead to motor improvement in arm-hand function. Robotic arm treatment helped decrease motor impairment and improved function in chronic stroke patients only. Therapist provided exercise programs (when self-administered by patients during their off-therapy time in a rehabilitation setting) did improve

  15. Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

    Science.gov (United States)

    Zhang, Ya-Jing; Cao, Hui-Juan; Li, Xin-Lin; Yang, Xiao-Ying; Lai, Bao-Yong; Yang, Guo-Yang; Liu, Jian-Ping

    2017-01-01

    Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included

  16. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    Directory of Open Access Journals (Sweden)

    Lois Biener

    2015-12-01

    Full Text Available This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740 in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2% than both former (32.3% and never smokers (7.6%; p < 0.001 and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001. Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  17. Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

    Directory of Open Access Journals (Sweden)

    Kevin Sweet

    2014-01-01

    Full Text Available We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF or hypertension (HTN, managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC. Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®. OSUWMC patient participants with chronic disease (CD receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1 change in risk perception; (2 knowledge retention; (3 perceived personal control; (4 health behavior change; and, for the active arm (5, overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices.

  18. Dry needling in the management of myofascial trigger points: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Espejo-Antúnez, Luis; Tejeda, Jaime Fernández-Huertas; Albornoz-Cabello, Manuel; Rodríguez-Mansilla, Juan; de la Cruz-Torres, Blanca; Ribeiro, Fernando; Silva, Anabela G

    2017-08-01

    This systematic review of randomized controlled trials aimed to examine the effectiveness of dry needling in the treatment of myofascial trigger points and to explore the impact of specific aspects of the technique on its effectiveness. Relevant studies published between 2000 and 2015 were identified by searching PubMed, Scopus, The Cochrane Library and Physiotherapy Evidence Database. Studies identified by electronic searches were screened against a set of pre-defined inclusion criteria. Fifteen studies were included in this systematic review. The main outcomes that were measured were pain, range of motion, disability, depression and quality of life. The results suggest that dry needling is effective in the short term for pain relief, increase range of motion and improve quality of life when compared to no intervention/sham/placebo. There is insufficient evidence on its effect on disability, analgesic medication intake and sleep quality. Despite some evidence for a positive effect in the short term, further randomized clinical trials of high methodological quality, using standardized procedures for the application of dry needling are needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Modeling and simulation of electronic structure, material interface and random doping in nano electronic devices

    Science.gov (United States)

    Chen, Duan; Wei, Guo-Wei

    2010-01-01

    The miniaturization of nano-scale electronic devices, such as metal oxide semiconductor field effect transistors (MOSFETs), has given rise to a pressing demand in the new theoretical understanding and practical tactic for dealing with quantum mechanical effects in integrated circuits. Modeling and simulation of this class of problems have emerged as an important topic in applied and computational mathematics. This work presents mathematical models and computational algorithms for the simulation of nano-scale MOSFETs. We introduce a unified two-scale energy functional to describe the electrons and the continuum electrostatic potential of the nano-electronic device. This framework enables us to put microscopic and macroscopic descriptions in an equal footing at nano scale. By optimization of the energy functional, we derive consistently-coupled Poisson-Kohn-Sham equations. Additionally, layered structures are crucial to the electrostatic and transport properties of nano transistors. A material interface model is proposed for more accurate description of the electrostatics governed by the Poisson equation. Finally, a new individual dopant model that utilizes the Dirac delta function is proposed to understand the random doping effect in nano electronic devices. Two mathematical algorithms, the matched interface and boundary (MIB) method and the Dirichlet-to-Neumann mapping (DNM) technique, are introduced to improve the computational efficiency of nano-device simulations. Electronic structures are computed via subband decomposition and the transport properties, such as the I-V curves and electron density, are evaluated via the non-equilibrium Green's functions (NEGF) formalism. Two distinct device configurations, a double-gate MOSFET and a four-gate MOSFET, are considered in our three-dimensional numerical simulations. For these devices, the current fluctuation and voltage threshold lowering effect induced by the discrete dopant model are explored. Numerical convergence

  20. Improving residents' code status discussion skills: a randomized trial.

    Science.gov (United States)

    Szmuilowicz, Eytan; Neely, Kathy J; Sharma, Rashmi K; Cohen, Elaine R; McGaghie, William C; Wayne, Diane B

    2012-07-01

    Inpatient Code Status Discussions (CSDs) are commonly facilitated by resident physicians, despite inadequate training. We studied the efficacy of a CSD communication skills training intervention for internal medicine residents. This was a prospective, randomized controlled trial of a multimodality communication skills educational intervention for postgraduate year (PGY) 1 residents. Intervention group residents completed a 2 hour teaching session with deliberate practice of communication skills, online modules, self-reflection, and a booster training session in addition to assigned clinical rotations. Control group residents completed clinical rotations alone. CSD skills of residents in both groups were assessed 2 months after the intervention using an 18 item behavioral checklist during a standardized patient encounter. Average scores for intervention and control group residents were calculated and between-group differences on the CSD skills assessment were evaluated using two-tailed independent sample t tests. Intervention group residents displayed higher overall scores on the simulated CSD (75.1% versus 53.2%, pgroup residents. The intervention group also displayed a greater number of key CSD communication behaviors and facilitated significantly longer conversations. The training, evaluation, and feedback sessions were rated highly. A focused, multimodality curriculum can improve resident performance of simulated CSDs. Skill improvement lasted for at least 2 months after the intervention. Further studies are needed to assess skill retention and to set minimum performance standards.

  1. A randomized trial of calorie labeling on menus.

    Science.gov (United States)

    Hammond, David; Goodman, Samantha; Hanning, Rhona; Daniel, Samantha

    2013-12-01

    Food consumed outside the home accounts for a growing proportion of the North American diet and has been associated with increased obesity. To examine the effect of nutrition labeling on menus on awareness, use, and food consumption, including the impact of "traffic light" labeling and adding other nutrients. Blinded, randomized trial with 635 Canadian adults conducted in 2010-2011. Participants ordered a free meal from one of four experimental menus: 1) no nutritional information shown, 2) calorie amounts only, 3) calorie amounts in "traffic lights", and 4) calorie, fat, sodium, and sugar shown in "traffic lights". Recall of nutrition information, knowledge of calorie content and nutrient consumption were assessed. Participants in the calorie conditions were more likely to recall the calorie content of meals and to report using nutrition information when ordering. The calorie content of meals was not significantly different across conditions; however, calorie consumption was significantly lower among participants in the Calorie-only condition compared to the No information condition (mean=-96 kcal, p=.048). Menu labeling increased awareness and use of nutrition information and reduced consumption. Adding "traffic lights", fat, sodium, and sugar amounts to menus had little impact compared to calorie-only labeling. © 2013.

  2. Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Bahl, Pinky; Puliyel, Jacob M

    2017-09-26

    To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. 72 infants (age Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score were compared between the 2 groups after 1 hour of treatment. 14 out of 32 in nCPAP group had change in respiratory rate ≥10, while 5 out of 35 had change in respiratory rate ≥10 with standard care (P=0.008). The mean (SD) change in respiratory rate following nCPAP was 8.03 (5.8), while with standard care it was 5.11 (3.98) (P=0.018). Mean (SD) change in Silverman-Anderson score following nCPAP was 0.78 (0.87), while with standard care it was 0.39 (0.73) (P=0.029). Mean (SD) change in Modified Pediatric Society of New Zealand Severity Score following nCPAP was 2.5 (3.01) compared to 1.08 (1.3) (P=0.012) with standard care. nCPAP helped reduce respiratory distress significantly compared to standard care.

  3. Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses.

    Science.gov (United States)

    Sivardeen, Ahmed; Laughton, Deborah; Wolffsohn, James S

    2016-02-01

    To assess the performance of four commercially available silicone hydrogel multifocal monthly contact lens designs against monovision. A double-masked randomized crossover trial of Air Optix Aqua multifocal, PureVision 2 for Presbyopia, Acuvue OASYS for Presbyopia, Biofinity multifocal, and monovision with Biofinity contact lenses was conducted on 35 presbyopes (54.3 ± 6.2 years). After 4 weeks of wear, visual performance was quantified by high- and low-contrast visual acuity under photopic and mesopic conditions, reading speed, defocus curves, stereopsis, halometry, aberrometry, Near Activity Visual Questionnaire rating, and subjective quality of vision scoring. Bulbar, limbal, and palpebral hyperemia and corneal staining were graded to monitor the impact of each contact lens on ocular physiology. High-contrast photopic visual acuity (p = 0.102), reading speed (F = 1.082, p = 0.368), and aberrometry (F = 0.855, p = 0.493) were not significantly different between presbyopic lens options. Defocus curve profiles (p lenses. Although ocular aberration variation between individuals largely masks the differences in optics between current multifocal contact lens designs, certain design strategies can outperform monovision, even in early presbyopes.

  4. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial.

    Science.gov (United States)

    Jacobs, Jonathan D; Foster, Megan; Wan, Jim; Pershad, Jay

    2014-01-01

    Research suggests that hypertonic saline (HS) may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared with 0.9% saline mixed with epinephrine. To our knowledge, 7% HS has not been previously investigated. We conducted a prospective, double-blind, randomized controlled trial in 101 infants presenting with moderate to severe acute bronchiolitis. Subjects received either 7% saline or 0.9% saline, both with epinephrine. Our primary outcome was a change in bronchiolitis severity score (BSS), obtained before and after treatment, and at the time of disposition from the emergency department (ED). Secondary outcomes measured were hospitalization rate, proportion of admitted patients discharged at 23 hours, and ED and inpatient length of stay. At baseline, study groups were similar in demographic and clinical characteristics. The decrease in mean BSS was not statistically significant between groups (2.6 vs 2.4 for HS and control groups, respectively). The difference between the groups in proportion of admitted patients (42% in HS versus 49% in normal saline), ED or inpatient length of stay, and proportion of admitted patients discharged at 23 hours was not statistically significant. In moderate to severe acute bronchiolitis, inhalation of 7% HS with epinephrine does not appear to confer any clinically significant decrease in BSS when compared with 0.9% saline with epinephrine.

  5. Reducing mucus production after urinary reconstruction: a prospective randomized trial.

    Science.gov (United States)

    N'Dow, J; Robson, C N; Matthews, J N; Neal, D E; Pearson, J P

    2001-05-01

    After transposition into the urinary tract, intestinal segments continue to produce mucus. We determine the effectiveness of muco-regulatory drugs, including N-acetylcysteine, aspirin and ranitidine, in reducing mucus secretion and urine viscosity in patients with transposed segments. Our trial was a prospective randomized, double-blind placebo controlled crossover study involving 12 patients who underwent ileal conduit and 31 who underwent bladder reconstruction. Each treatment lasted 3 weeks with a 2-week washout. Pretreatment and posttreatment 24-hour urine samples were analyzed for mucin and viscosity after papain digestion, sodium dodecyl sulfate-polyacrylamide gel electrophoresis and periodic acid-Schiff assay. A disease specific questionnaire and SF-36 quality of life survey were completed. According to the questionnaire, mucus production did not decrease with time in 67% of patients. Mucin comprised 3% of the total nondialyzable material in urine (65 mg./24-hour for ileal conduit and 60 mg./24-hour for bladder reconstruction). Analysis of questionnaires and laboratory results failed to demonstrate any benefit of taking muco-regulatory agents compared with placebo. The use of N-acetylcysteine, aspirin and ranitidine did not result in a reduction in mucin production, urine viscosity or improvement in quality of life.

  6. Childhood Fruit and Vegetable Intake: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Rafaela Rosário

    2012-01-01

    Full Text Available Our study aimed to assess the impact of a six-months nutrition program, taught by trained teachers, on fruit and vegetable consumption among children in grades 1 to 4. Four hundred and sixty-four children (239 female, 6 to 12 years old, from seven elementary schools were assigned to this randomized trial. Teachers were trained by researchers over six months, according to the following topics: nutrition, healthy eating, and strategies to increase physical activity. After each session, teachers were encouraged to develop activities in the classroom on the topics learned. Children's sociodemographic, anthropometric, dietary, and physical activity data were assessed at baseline and at the end of the intervention. The effect sizes ranged between small (Cohen's d=0.12 on “other vegetables” to medium (0.56 on “fruit and vegetable”, and intervened children reported a significantly higher consumption of vegetables and fruit. Interventions involving trained teachers offer promise to increase consumption of fruit and vegetable in children.

  7. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Hung, Shao Kang; Perry, Rachel; Ernst, Edzard

    2011-02-15

    To critically assess the current evidence from randomized clinical trials (RCTs) for or against the effectiveness or efficacy of Rhodiola rosea. Systematic literature searches were performed in six electronic databases: AMED (1985-July 2009), CINAHL (1982-July 2009), The Cochrane Library (search in July 2009), EMBASE (1974-July 2009), MEDLINE (1950-July 2009) and Web of Science (searched in July 2009). No language restrictions were imposed. Reference lists of all retrieved articles were searched, and experts and manufacturers were contacted for unpublished RCT. RCTs testing the efficacy or effectiveness of mono-preparations of R. rosea as sole treatment administered orally against a control intervention in any human individual suffering from any condition or healthy human volunteers were included. Studies were selected, data extracted, and quality assessed by two independent reviewers. Eleven RCTs met the inclusion criteria; all were placebo-controlled. Six trials investigated the effects of R. rosea on physical performance, four on mental performance, and two in patients diagnosed with mental health condition. The methodological quality of most trials was moderate or good. Only few mild adverse events were reported. R. rosea may have beneficial effects on physical performance, mental performance, and certain mental health conditions. There is, however, a lack of independent replications of the single different studies. Five of the 10 RCTs reached more than three points on the Jadad score (i.e., good quality). More research seems warranted. Copyright © 2010 Elsevier GmbH. All rights reserved.

  8. Meditation for migraines: a pilot randomized controlled trial.

    Science.gov (United States)

    Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

    2014-10-01

    Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P

  9. A randomized controlled Alzheimer's disease prevention trial's evolution into an exposure trial: the PREADViSE Trial.

    Science.gov (United States)

    Kryscio, R J; Abner, E L; Schmitt, F A; Goodman, P J; Mendiondo, M; Caban-Holt, A; Dennis, B C; Mathews, M; Klein, E A; Crowley, J J

    2013-01-01

    To summarize the ongoing prevention of Alzheimer's disease (AD) by vitamin E and selenium (PREADViSE) trial as an ancillary study to SELECT (a large prostate cancer prevention trial) and to present the blinded results of the first year as an exposure study. PREADViSE was designed as a double blind randomized controlled trial (RCT). SELECT terminated after median of 5.5 years of exposure to supplements due to a futility analysis. Both trials then converted into an exposure study. In the randomized component PREADViSE enrolled 7,547 men age 62 or older (60 if African American). Once the trial terminated 4,246 of these men volunteered for the exposure study. Demographics were similar for both groups with exposure volunteers having baseline mean age 67.3 ± 5.2 years, 15.3 ± 2.4 years of education, 9.8% African Americans, and 22.0% reporting a family history of dementia. In the RCT men were randomly assigned to either daily doses of 400 IU of vitamin E or placebo and 200 µg of selenium or placebo using a 2x2 factorial structure. In the RCT, participants completed the memory impairment screen (MIS), and if they failed, underwent a longer screening (based on an expanded Consortium to Establish a Registry in AD [CERAD] battery). CERAD failure resulted in visits to their clinician for medical examination with records of these examinations forwarded to the PREADViSE center for further review. In the exposure study, men are contacted by telephone and complete the telephone version of the memory impairment screen (MIS-T) screen. If they fail the MIS-T, a modified telephone interview of cognitive status (TICS-M) exam is given. A failed TICS-M exam also leads to a visit to their clinician for an in-depth examination and forwarding of records for a centralized consensus diagnosis by expert clinicians. A subgroup of the men who pass the MIS-T also take the TICS-M exam for validation purposes. While this ancillary trial was open to all 427 SELECT clinical sites, only 130 (30

  10. Sweet Sixteen: The Prospective Clinical Trials of John L. Cameron, MD-The Clinician-Scientist: From Alternate-Allocation to Randomized Controlled Trials.

    Science.gov (United States)

    Yeo, Charles J

    2017-09-15

    : The era of randomized controlled trials was ushered in by the British epidemiologist-statistician Austin Bradford Hill, with his work on the use of streptomycin in patients with tuberculosis. John L. Cameron, can be linked to 16 prospective clinical trials over his career thus far, starting with alternate-allocation trials and transitioning to prospective, randomized, placebo-controlled trials. These trials studied various topics in surgery-from pancreatitis to surgical site infections, to drain trials, a trial in Crohn disease and multiple trials in pancreatic surgery and cancer. Herein are described the "sweet sixteen" prospective clinical trials of Dr Cameron.

  11. Cupping therapy for acute and chronic pain management: a systematic review of randomized clinical trials

    OpenAIRE

    Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping

    2014-01-01

    Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...

  12. Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Nicolaisen, Anne; Gilså Hansen, Dorte; Mariet, Hagedoorn,

    Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial.......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial....

  13. Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Nicolaisen, Anne; Gilså Hansen, Dorte; Hariet, Hagedoorn,

    Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial......Hand-in-Hand. Psychological Intervention for Women Newly Diagnosed with Cancer and their Partners. A Randomized Controlled Trial...

  14. OXYTOCIN - AN EMERGING TREATMENT FOR OBESITY AND DYSGLYCEMIA: REVIEW OF RANDOMIZED CONTROLLED TRIALS AND COHORT STUDIES.

    Science.gov (United States)

    Barengolts, Elena

    2016-07-01

    The psychotropic mediator and neuropeptide hormone oxytocin (OXT) is emerging as a promising treatment of metabolic disorders (obesity and dysglycemia). This review focuses on studies relevant to OXT use and its mechanisms of action in metabolic disorders and wellness behavior motivation. Randomized controlled trials (RCTs) and cohort and preclinical studies identified in electronic databases were reviewed. There were only a few RCTs and cohort studies related to OXT and metabolic disorders. Anorexigenic and weight-loss effects of intranasal OXT (IOXT) were evaluated in 3 double-blind RCTs involving 85 subjects. A single dose of 24 IU reduced caloric intake by 122 kcal. The 24 IU 4-times daily dose for 8 weeks produced ~9-kg weight loss (Poxytocin OXTR = oxytocin receptor sOXT = serum oxytocin.

  15. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

    Science.gov (United States)

    Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

    2015-06-01

    Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings. © The Author(s) 2015.

  16. Echinacea for treating the common cold: a randomized trial.

    Science.gov (United States)

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Mundt, Marlon; Bone, Kerry; Barlow, Shari; Ewers, Tola

    2010-12-21

    Echinacea is widely used to treat the common cold. To assess the potential benefits of echinacea as a treatment of common cold. Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) Dane County, Wisconsin. 719 patients, aged 12 to 80 years, with new-onset common cold. Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1

  17. Hair removal policies in clean surgery: systematic review of randomized, controlled trials.

    Science.gov (United States)

    Niël-Weise, B S; Wille, J C; van den Broek, P J

    2005-12-01

    To determine whether certain hair removal policies are better than others to prevent surgical-site infections in patients undergoing clean surgery. Publications were retrieved by a systematic search of Medline, the Cochrane Library, and EMBASE up to February 2005. Additionally, the reference lists of all identified trials were examined. All randomized trials, quasi-randomized trials, and systematic reviews or meta-analyses of randomized or quasi-randomized trials comparing hair removal policies in clean surgery were selected. Trials involving patients undergoing cranial neurosurgery were excluded. Two reviewers independently assessed trial quality and extracted data. Disagreements were resolved by discussion with a third reviewer. Data from the original publications were used to calculate the relative risk or risk difference of surgical-site infection. Data for similar outcomes were combined in the analysis, where appropriate, with the use of a random effects model. Four trials were included in the review. No eligible systematic review or meta-analysis of randomized or quasi-randomized trials was found. The quality of the trials and how they were reported were generally unsatisfactory. Evidence regarding whether preoperative hair removal has any effect was inconclusive. When hair removal was considered necessary, evidence about the best time for removal was inconclusive. There was some evidence that hair removal by clipper is superior to removal by razor. Because of insufficient evidence as a basis for recommendations, the practical consequences for ward management were essential when the Dutch Working Party on Infection Prevention formulated its recommendations for hair removal policies. Large randomized, controlled trials are needed to determine the optimal policy for preoperative hair removal.

  18. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping.

    Science.gov (United States)

    Biener, Lois; Song, Eunyoung; Sutfin, Erin L; Spangler, John; Wolfson, Mark

    2015-12-17

    This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes) among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740) in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2%) than both former (32.3%) and never smokers (7.6%; p e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  19. Effectiveness of treatment approaches for children and adolescents with reading disabilities: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Galuschka, Katharina; Ise, Elena; Krick, Kathrin; Schulte-Körne, Gerd

    2014-01-01

    Children and adolescents with reading disabilities experience a significant impairment in the acquisition of reading and spelling skills. Given the emotional and academic consequences for children with persistent reading disorders, evidence-based interventions are critically needed. The present meta-analysis extracts the results of all available randomized controlled trials. The aims were to determine the effectiveness of different treatment approaches and the impact of various factors on the efficacy of interventions. The literature search for published randomized-controlled trials comprised an electronic search in the databases ERIC, PsycINFO, PubMed, and Cochrane, and an examination of bibliographical references. To check for unpublished trials, we searched the websites clinicaltrials.com and ProQuest, and contacted experts in the field. Twenty-two randomized controlled trials with a total of 49 comparisons of experimental and control groups could be included. The comparisons evaluated five reading fluency trainings, three phonemic awareness instructions, three reading comprehension trainings, 29 phonics instructions, three auditory trainings, two medical treatments, and four interventions with coloured overlays or lenses. One trial evaluated the effectiveness of sunflower therapy and another investigated the effectiveness of motor exercises. The results revealed that phonics instruction is not only the most frequently investigated treatment approach, but also the only approach whose efficacy on reading and spelling performance in children and adolescents with reading disabilities is statistically confirmed. The mean effect sizes of the remaining treatment approaches did not reach statistical significance. The present meta-analysis demonstrates that severe reading and spelling difficulties can be ameliorated with appropriate treatment. In order to be better able to provide evidence-based interventions to children and adolescent with reading disabilities

  20. Randomized controlled trials 5: Determining the sample size and power for clinical trials and cohort studies.

    Science.gov (United States)

    Greene, Tom

    2015-01-01

    Performing well-powered randomized controlled trials is of fundamental importance in clinical research. The goal of sample size calculations is to assure that statistical power is acceptable while maintaining a small probability of a type I error. This chapter overviews the fundamentals of sample size calculation for standard types of outcomes for two-group studies. It considers (1) the problems of determining the size of the treatment effect that the studies will be designed to detect, (2) the modifications to sample size calculations to account for loss to follow-up and nonadherence, (3) the options when initial calculations indicate that the feasible sample size is insufficient to provide adequate power, and (4) the implication of using multiple primary endpoints. Sample size estimates for longitudinal cohort studies must take account of confounding by baseline factors.

  1. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial.

    Science.gov (United States)

    Liu-Ambrose, Teresa; Best, John R; Davis, Jennifer C; Eng, Janice J; Lee, Philip E; Jacova, Claudia; Boyd, Lara A; Brasher, Penelope M; Munkacsy, Michelle; Cheung, Winnie; Hsiung, Ging-Yuek R

    2016-11-15

    To assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI). This was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training. Primary outcomes assessed were general cognitive function (Alzheimer's Disease Assessment Scale-Cognitive subscale [ADAS-Cog]), executive functions (Executive Interview [EXIT-25]), and activities of daily living (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL]). Seventy adults randomized to aerobic exercise training or usual care were included in intention-to-treat analyses (mean age 74 years, 51% female, n = 35 per group). At the end of the intervention, the aerobic exercise training group had significantly improved ADAS-Cog performance compared with the usual care plus education group (-1.71 point difference, 95% confidence interval [CI] -3.15 to -0.26, p = 0.02); however, this difference was not significant at the 6-month follow-up (-0.63 point difference, 95% CI -2.34 to 1.07, p = 0.46). There were no significant between-group differences at intervention completion and at the 6-month follow-up in EXIT-25 or ADCS-ADL performance. Examination of secondary measures showed between-group differences at intervention completion favoring the AT group in 6-minute walk distance (30.35 meter difference, 95% CI 5.82 to 54.86, p = 0.02) and in diastolic blood pressure (-6.89 mm Hg difference, 95% CI -12.52 to -1.26, p = 0.02). This study provides preliminary evidence for the efficacy of 6 months of thrice-weekly progressive aerobic training in community-dwelling adults with mild SIVCI, relative to usual care plus education. NCT01027858. This study

  2. Kangaroo mother care for infantile colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Reza Saeidi

    2010-03-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 st1":*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Infantile colic has been defined as episodes of excessive and persistent crying without known medical cause. Kangaroo mother care is a new method for baby care with several advantages. A universally available and biologically sound method of care for all newborns, with three components: skin-to-skin contact, exclusive breastfeeding, support to the mother-infant dyad. This study designed for evaluating Kangaroo mother care on infantile colic.  "n"nMethods: This study was a randomized controlled trial. From 1th may 2008 to 1 may 2009 a total of 70 children, aged 3-12 weeks with persistent colic symptoms were studied. The children were referred to Sheikh clinic, Mashhad, Iran, because of excessive crying. Normal mother-infant pairs were recruited at 3 to 12 weeks of age after obtaining baseline for two days. Subjects divided randomly to kangaroo care or conventional care group and mothers in both groups filled diary for seven days. "n"nResults: In the beginning of the study, the infants in kangaroo care group had 3.5 hr/d crying and after the intervention, it decreased to 1.7 hr/d, the difference were significant (p<0.05. But there were no difference in feeding duration between

  3. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial).

    Science.gov (United States)

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

    2013-05-23

    More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. The results of the trial will be used to produce a maximally effective sexual assault resistance

  4. Massage Therapy for Fibromyalgia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Science.gov (United States)

    Li, Yan-hui; Wang, Feng-yun; Feng, Chun-qing; Yang, Xia-feng; Sun, Yi-hua

    2014-01-01

    Background Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial. Objective The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. Methods Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I2 statistic. Results Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI −0.38 to 0.75; p = 0.52). Conclusion Massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings. PMID:24586677

  5. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yan-hui Li

    Full Text Available BACKGROUND: Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM, the role of massage therapy in the management of FM remained controversial. OBJECTIVE: The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM. METHODS: Electronic databases (up to June 2013 were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD and 95% confidence intervals (CI were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I(2 statistic. RESULTS: Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥ 5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03, anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01, and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005 in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI -0.38 to 0.75; p = 0.52. CONCLUSION: Massage therapy with duration ≥ 5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.

  6. Dietary Fiber Supplementation for Fecal Incontinence: A Randomized Clinical Trial

    Science.gov (United States)

    Bliss, Donna Z.; Savik, Kay; Jung, Hans-Joachim G.; Whitebird, Robin; Lowry, Ann; Sheng, Xioayan

    2014-01-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appear related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. PMID:25155992

  7. Dietary fiber supplementation for fecal incontinence: a randomized clinical trial.

    Science.gov (United States)

    Bliss, Donna Z; Savik, Kay; Jung, Hans-Joachim G; Whitebird, Robin; Lowry, Ann; Sheng, Xiaoyan

    2014-10-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appears related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16 g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. © 2014 Wiley Periodicals, Inc.

  8. Modifying media content for preschool children: a randomized controlled trial.

    Science.gov (United States)

    Christakis, Dimitri A; Garrison, Michelle M; Herrenkohl, Todd; Haggerty, Kevin; Rivara, Frederick P; Zhou, Chuan; Liekweg, Kimberly

    2013-03-01

    Although previous studies have revealed that preschool-aged children imitate both aggression and prosocial behaviors on screen, there have been few population-based studies designed to reduce aggression in preschool-aged children by modifying what they watch. We devised a media diet intervention wherein parents were assisted in substituting high quality prosocial and educational programming for aggression-laden programming without trying to reduce total screen time. We conducted a randomized controlled trial of 565 parents of preschool-aged children ages 3 to 5 years recruited from community pediatric practices. Outcomes were derived from the Social Competence and Behavior Evaluation at 6 and 12 months. At 6 months, the overall mean Social Competence and Behavior Evaluation score was 2.11 points better (95% confidence interval [CI]: 0.78-3.44) in the intervention group as compared with the controls, and similar effects were observed for the externalizing subscale (0.68 [95% CI: 0.06-1.30]) and the social competence subscale (1.04 [95% CI: 0.34-1.74]). The effect for the internalizing subscale was in a positive direction but was not statistically significant (0.42 [95% CI: -0.14 to 0.99]). Although the effect sizes did not noticeably decay at 12 months, the effect on the externalizing subscale was no longer statistically significant (P = .05). In a stratified analysis of the effect on the overall scores, low-income boys appeared to derive the greatest benefit (6.48 [95% CI: 1.60-11.37]). An intervention to reduce exposure to screen violence and increase exposure to prosocial programming can positively impact child behavior.

  9. Hemodialysis catheter design and catheter performance: a randomized controlled trial.

    Science.gov (United States)

    Van Der Meersch, Hans; De Bacquer, Dirk; Vandecasteele, Stefaan J; Van den Bergh, Barbara; Vermeiren, Pieter; De Letter, Jan; De Vriese, An S

    2014-12-01

    A complication of long-term use of tunneled cuffed catheters for hemodialysis is the high rate of infection and thrombus-related dysfunction. Specific mechanical features of tunneled cuffed catheters may improve hemodynamic performance and decrease thrombosis and infection rates. However, there currently is no proven advantage of one design over another. Single-center randomized clinical trial. 302 hemodialysis patients who required a tunneled cuffed catheter as temporary or definite vascular access. Palindrome Symmetric Tip Dialysis Catheter or HemoStar Long-Term Hemodialysis Catheter. The primary end point was primary assisted patency. Secondary end points were incidence of catheter-related bloodstream infections (CRBSIs), thrombosis, and 2 indicators of rheologic function: mean effective blood flow rate and urokinase use. Mean primary assisted patency was 135.9 days for Palindrome and 136.5 days for HemoStar (P=0.8). Definite CRBSI occurred in 0.24 and 0.10/1,000 catheter-days for Palindrome and HemoStar, respectively (P=0.3). Removal rates for thrombosis that could not be resolved with thrombolysis were 0.53 and 0.43/1,000 catheter-days for Palindrome and HemoStar, respectively (P=0.7). Urokinase use was lower for Palindrome than for HemoStar, as evidenced by a lower number of urokinase infusions/1,000 catheter-days (17 and 35; Pcatheters that never required thrombolysis (58% and 45%; P=0.03). Mean effective blood flow rate was higher for Palindrome than for HemoStar (333 and 304mL/min; Pcatheter types. The Palindrome catheter required less thrombolysis and achieved higher blood flow rates than the HemoStar catheter. These findings suggest that mechanical catheter design may improve catheter rheology, but does not affect risks for thrombosis and infection and hence catheter survival. Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  10. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial.

    Science.gov (United States)

    Katheria, Anup; Poeltler, Debra; Durham, Jayson; Steen, Jane; Rich, Wade; Arnell, Kathy; Maldonado, Mauricio; Cousins, Larry; Finer, Neil

    2016-11-01

    To assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only). Inborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry. There was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes. V-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping. ClinicalTrials.gov: NCT02231411. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Workplace based mindfulness practice and inflammation: a randomized trial.

    Science.gov (United States)

    Malarkey, William B; Jarjoura, David; Klatt, Maryanna

    2013-01-01

    We have developed a low dose Mindfulness-Based Intervention (MBI-ld) that reduces the time committed to meetings and formal mindfulness practice, while conducting the sessions during the workday. This reduced the barriers commonly mentioned for non-participation in mindfulness programs. In a controlled randomized trial we studied university faculty and staff (n=186) who were found to have an elevated CRP level,>3.0 mg/ml, and who either had, or were at risk for cardiovascular disease. This study was designed to evaluate if MBI-ld could produce a greater decrease in CRP, IL-6 and cortisol than an active control group receiving a lifestyle education program when measured at the end of the 2 month interventions. We found that MBI-ld significantly enhanced mindfulness by 2-months and it was maintained for up to a year when compared to the education control. No significant changes were noted between interventions in cortisol, IL-6 levels or self-reported measures of perceived stress, depression and sleep quality at 2-months. Although not statistically significant (p=.08), the CRP level at 2-months was one mg/ml lower in the MBI-ld group than in the education control group, a change which may have clinical significance (Ridker et al., 2000; Wassel et al., 2010). A larger MBI-ld effect on CRP (as compared to control) occurred among participants who had a baseline BMI 30 (-0.18 mg/ml). We conclude that MBI-ld should be more fully investigated as a low-cost self-directed complementary strategy for decreasing inflammation, and it seems most promising for non-obese subjects. Copyright © 2012 Elsevier Inc. All rights reserved.

  12. Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

    Science.gov (United States)

    Nayak, Rahul K; Wendler, David; Miller, Franklin G; Kim, Scott Y H

    2015-09-01

    Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

  13. Digital health intervention during cardiac rehabilitation: A randomized controlled trial.

    Science.gov (United States)

    Widmer, R Jay; Allison, Thomas G; Lennon, Ryan; Lopez-Jimenez, Francisco; Lerman, Lilach O; Lerman, Amir

    2017-06-01

    Digital health interventions (DHI) have been shown to improve intermediates of cardiovascular health, but their impact on cardiovascular (CV) outcomes has not been fully explored. The aim of this study was to determine whether DHI administered during cardiac rehabilitation (CR) would reduce CV-related emergency department (ED) visits and rehospitalizations in patients after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). We randomized patients undergoing CR following ACS and PCI to standard CR (n=40) or CR+DHI (n=40) for 3 months with 3 patients withdrawing from CR prior to initiation in the treatment arm and 6 in the control group. The DHI incorporated an online and smartphone-based CR platform asking the patients to report of dietary and exercise habits throughout CR as well as educational information toward patients' healthy lifestyles. We obtained data regarding ED visits and rehospitalizations at 180 days, as well as other metrics of secondary CV prevention at baseline and 90 days. Baseline demographics were similar between the groups. The DHI+CR group had improved weight loss compared to the control group (-5.1±6.5 kg vs. -0.8±3.8 kg, respectively, P=.02). Those in the DHI+CR group also showed a non-significant reduction in CV-related rehospitalizations plus ED visits compared to the control group at 180 days (8.1% vs 26.6%; RR 0.30, 95% CI 0.08-1.10, P=.054). The current study demonstrated that complementary DHI significantly improves weight loss, and might offer a method to reduce CV-related ED visits plus rehospitalizations in patients after ACS undergoing CR. The study suggests a role for DHI as an adjunct to CR to improve secondary prevention of CV disease. This trial is registered at clinicaltrials.gov (NCT01883050). Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Randomized open-label trial of dextromethorphan in Rett syndrome.

    Science.gov (United States)

    Smith-Hicks, Constance L; Gupta, Siddharth; Ewen, Joshua B; Hong, Manisha; Kratz, Lisa; Kelley, Richard; Tierney, Elaine; Vaurio, Rebecca; Bibat, Genila; Sanyal, Abanti; Yenokyan, Gayane; Brereton, Nga; Johnston, Michael V; Naidu, Sakkubai

    2017-10-17

    To determine safety and perform a preliminary assessment of dose-dependent efficacy of dextromethorphan in normalizing electrographic spikes, clinical seizures, and behavioral and cognitive functions in girls with Rett syndrome. We used a prospective randomized, open-label trial in fast metabolizers of dextromethorphan to examine the effect of dextromethorphan on core clinical features of Rett syndrome. Interictal spike activity and clinical seizures were determined using EEG and parent reporting. Cognitive data were obtained using the Mullen Scales of Early Learning and Vineland Adaptive Behavior Scales, while behavioral data were obtained from parent-completed checklists, the Aberrant Behavior Checklist-Community Version, and the Screen for Social Interaction. Anthropometric data were obtained according to the National Health and Nutrition Examination Survey. The Rett Syndrome Severity Scale provided a clinical global impression of the effect of dextromethorphan on clinical severity. Dextromethorphan is safe for use in 3- to 15-year-old girls with Rett syndrome. Thirty-five girls were treated with 1 of 3 doses of dextromethorphan over a period of 6 months. Statistically significant dose-dependent improvements were seen in clinical seizures, receptive language, and behavioral hyperactivity. There was no significant improvement in global clinical severity as measured by the Rett Syndrome Severity Scale. Dextromethorphan is a potent noncompetitive antagonist of the NMDA receptor channel that is safe for use in young girls with Rett syndrome. Preliminary evidence suggests that dextromethorphan may improve some core features of Rett syndrome. This study provides Class IV evidence that dextromethorphan at various doses does not change EEG spike counts over 6 months, though precision was limited to exclude an important effect. © 2017 American Academy of Neurology.

  15. Oxytocin and autism: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Preti, Antonio; Melis, Mariangela; Siddi, Sara; Vellante, Marcello; Doneddu, Giuseppe; Fadda, Roberta

    2014-03-01

    Little is known about the effectiveness of pharmacological interventions on autism spectrum disorder (ASD). This is a systematic review of the randomized controlled trials (RCTs) of oxytocin interventions in autism, made from January 1990 to September 2013. A search of computerized databases was supplemented by manual search in the bibliographies of key publications. The methodological quality of the studies included in the review was evaluated independently by two researchers, according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. The review yielded seven RCTs, including 101 subjects with ASD (males=95) and 8 males with Fragile X syndrome. The main categories of target symptoms tested in the studies were repetitive behaviors, eye gaze, and emotion recognition. The studies had a medium to high risk of bias. Most studies had small samples (median=15). All the studies but one reported statistically significant between-group differences on at least one outcome variable. Most findings were characterized by medium effect size. Only one study had evidence that the improvement in emotion recognition was maintained after 6 weeks of treatment with intranasal oxytocin. Overall, oxytocin was well tolerated and side effects, when present, were generally rated as mild; however, restlessness, increased irritability, and increased energy occurred more often under oxytocin. RCTs of oxytocin interventions in autism yielded potentially promising findings in measures of emotion recognition and eye gaze, which are impaired early in the course of the ASD condition and might disrupt social skills learning in developing children. There is a need for larger, more methodologically rigorous RCTs in this area. Future studies should be better powered to estimate outcomes with medium to low effect size, and should try to enroll female participants, who were rarely considered in previous studies. Risk of bias should be minimized. Human long

  16. Randomized Controlled Trials of Pediatric Massage: A Review

    Directory of Open Access Journals (Sweden)

    Shay Beider

    2007-01-01

    Full Text Available The existing reviews of massage therapy (MT research are either limited to infants, adults, or were conducted prior to the publication of the most recent studies using pediatric samples. Randomized controlled trials (RCTs of pediatric MT are reviewed. A literature search yielded 24 RCTs of pediatric MT, defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age. Because RCTs of pediatric MT varied considerably in the amount and types of data reported, quantitative and narrative review methods were both used. Single-dose and multiple-dose effects were examined separately. Among single-dose effects, significant reductions of state anxiety were observed at the first session (g = 0.59, P < 0.05 and the last session (g = 1.10, P < 0.01 of a course of treatment. Effects for salivary cortisol (g = 0.28, negative mood (g = 0.52 and behavior (g = 0.37 were non-significant. Three of eleven multiple-dose effects were statistically significant. These were trait anxiety (g = 0.94, P < 0.05, muscle tone (g = 0.90, P < 0.01 and arthritis pain (g = 1.33, P < 0.01. Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results. MT benefits pediatric recipients, though not as universally as sometimes reported. Numerous weaknesses endemic to MT research (e.g. low statistical power, frequent failure to report basic descriptive statistics are identified, and recommendations for future pediatric MT research are discussed.

  17. The D-Health Trial: A randomized trial of vitamin D for prevention of mortality and cancer.

    Science.gov (United States)

    Neale, R E; Armstrong, B K; Baxter, C; Duarte Romero, B; Ebeling, P; English, D R; Kimlin, M G; McLeod, D S A; O Connell, R L; van der Pols, J C; Venn, A J; Webb, P M; Whiteman, D C; Wockner, L

    2016-05-01

    Vitamin D, specifically serum 25(OH)D has been associated with mortality, cancer and multiple other health endpoints in observational studies, but there is a paucity of clinical trial evidence sufficient to determine the safety and effectiveness of population-wide supplementation. We have therefore launched the D-Health Trial, a randomized trial of vitamin D supplementation for prevention of mortality and cancer. Here we report the methods and describe the trial cohort. The D-Health Trial is a randomized placebo-controlled trial, with planned intervention for 5years and a further 5years of passive follow-up through linkage with health and death registers. Participants aged 65-84years were recruited from the general population of Australia. The intervention is monthly oral doses of 60,000IU of cholecalciferol or matching placebo. The primary outcome is all-cause mortality. Secondary outcomes are total cancer incidence and colorectal cancer incidence. We recruited 21,315 participants to the trial between February 2014 and May 2015. The participants in the two arms of the trial were well-balanced at baseline. Comparison with Australian population statistics shows that the trial participants were less likely to report being in fair or poor health, to be current smokers or to have diabetes than the Australian population. However, the proportion overweight or with health conditions such as arthritis and angina was similar. Observational data cannot be considered sufficient to support interventions delivered at a population level. Large-scale randomized trials such as the D-Health Trial are needed to inform public health policy and practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Dilatation or no dilatation of the cervix during cesarean section (Dondi Trial): a randomized controlled trial.

    Science.gov (United States)

    Kirscht, Jade; Weiss, Christel; Nickol, Jana; Berlit, Sebastian; Tuschy, Benjamin; Hoch, Benjamin; Trebin, Amelie-Verena; Große-Steffen, Thomas; Sütterlin, Marc; Kehl, Sven

    2017-01-01

    To assess the effects of mechanical dilatation of the cervix during cesarean section on postoperative morbidity. A total of 447 women with elective cesarean section were included in the Dondi trial (Dilatation or no dilatation of the cervix during cesarean section). The primary outcome measure of this randomized controlled trial was postpartum hemorrhage (PPH) within 6 weeks. Infectious morbidity (puerperal fever, endometritis, wound infection, and urinary tract infection), blood loss (need for blood transfusion or change in hemoglobin levels), and operating time were also evaluated. The rate of PPH within 6 weeks was not different between the two groups [dilatation group: 5 (2.4 %), no dilatation group: 3 (1.2 %), p = 0.479]. Infectious morbidity, blood loss, and operating time were not diverse as well. The only significant difference between the two groups was the rate of retained products of conception with fewer cases after cervical dilatation (0 versus 6.2 %, p Dilatation of the cervix during cesarean section compared with no dilatation of the cervix did not influence the risk of postpartum hemorrhage. However, there were fewer cases with retained products of conception after dilatation.

  19. Use of antibacterial sutures for skin closure in controlling surgical site infections: a systematic review of published randomized, controlled trials.

    Science.gov (United States)

    Sajid, Muhammad S; Craciunas, L; Sains, P; Singh, K K; Baig, M K

    2013-07-01

    The objective of this article is to systematically analyse the randomized, controlled trials that compare the use of antibacterial sutures (ABS) for skin closure in controlling surgical site infections. Randomized, controlled trials on surgical patients comparing the use of ABS for skin closure in controlling the surgical site infections were analysed systematically using RevMan® and combined outcomes were expressed as odds ratios (OR) and standardized mean differences (SMD). Seven randomized, controlled trials evaluating 1631 patients were retrieved from electronic databases. There were 760 patients in the ABS group and 871 patients in the simple suture group. There was moderate heterogeneity among trials (Tau(2) = 0.12; chi(2) = 8.40, df = 6 [P surgical patients was associated with a reduced risk of developing surgical site infections (OR, 0.16; 95% CI, 0.37, 0.99; z = 2.02; P surgical procedures. Use of ABS for skin closure in surgical patients is effective in reducing the risk of surgical site infection and postoperative complications. ABS is comparable with SS in terms of length of hospital stay and duration of operation.

  20. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

    Directory of Open Access Journals (Sweden)

    Guzzetti Stefano

    2009-04-01

    Full Text Available Abstract Background Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA with volatile-based neuroanaesthesia (VA has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. Methods/Design NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III and Glasgow Coma Scale (GCS equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil. The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point. Two statistical comparisons have been planned: 1 sevoflurane + fentanyl vs. propofol + remifentanil; 2 sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a measurement of urinary catecholamines and plasma and urinary cortisol and (b estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded

  1. Randomized trial within a trial of yellow 'post-it notes' did not improve questionnaire response rates among participants in a trial of treatments for neck pain.

    Science.gov (United States)

    Tilbrook, Helen E; Becque, Taeko; Buckley, Hannah; MacPherson, Hugh; Bailey, Mathew; Torgerson, David J

    2015-04-01

    Attrition is a threat to the validity of randomized trials. Few randomized studies have been conducted within randomized trials to test methods of reducing attrition. To test whether using yellow post-it notes on follow-up questionnaires in the ATLAS treatment trial for neck pain reduces attrition. Nested trial within a trial. ATLAS participants were randomized to have their 6-month follow-up questionnaire have a 3' yellow post-it note with a handwritten message encouraging return of questionnaire. 499 participants were independently randomized using simple allocation to receive the post-it notes or not. Two hundred fifteen of the 256 (84.0%) participants in the intervention group returned their questionnaire compared with 205 of the 243 (84.4%) in the control group. There was no difference in time to response. Yellow post-it notes do not enhance questionnaire return rates for participants in a randomized trial of neck pain. © 2014 John Wiley & Sons, Ltd.

  2. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  3. Quantitative overview of randomized trials of amiodarone to prevent sudden cardiac death.

    Science.gov (United States)

    Sim, I; McDonald, K M; Lavori, P W; Norbutas, C M; Hlatky, M A

    1997-11-04

    Some randomized clinical trials of amiodarone therapy to prevent sudden cardiac death have had positive results and others have had negative results, but all were relatively small. This meta-analysis aimed to pool all trials to assess the effect of amiodarone on mortality and the impact of differences in patient population and study design on trial outcomes. Fifteen randomized trials were identified, and outcome measures were combined by use of a random effects model. The effect of patient population and study design on total mortality was assessed by use of a hierarchical Bayes model. Amiodarone reduced total mortality by 19% (confidence limits, 6% to 31%; Ptrials enrolling patients after myocardial infarction (21%), with left ventricular dysfunction (22%), and after cardiac arrest (25%). There was a trend toward greater risk reduction in trials requiring evidence of ventricular ectopy (25%) than in the remaining trials (10%). The trials using placebo controls had considerably less risk reduction (10%) than trials with active controls (27%) or usual care controls (42%, posterior odds Amiodarone reduced total mortality by 10% to 19% in patients at risk of sudden cardiac death. Amiodarone reduced risk similarly in patients after myocardial infarction, with heart failure, or with clinically evident arrhythmia. The apparent inconsistencies among results of randomized trials appear to be due to small sample sizes and the type of control group used, not the type of patient enrolled.

  4. Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

    Science.gov (United States)

    Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

    2014-01-01

    Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

  5. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records.

    Science.gov (United States)

    Yamamoto, Keiichi; Yamanaka, Kenya; Hatano, Etsuro; Sumi, Eriko; Ishii, Takamichi; Taura, Kojiro; Iguchi, Kohta; Teramukai, Satoshi; Yokode, Masayuki; Uemoto, Shinji; Fukushima, Masanori

    2012-08-01

    Various information technologies currently are used to improve the efficiency of clinical trials. However, electronic medical records (EMRs) are not yet linked to the electronic data capture (EDC) system. Therefore, the data must be extracted from medical records and transcribed to the EDC system. Clinical pathways are planned process patterns that are used in routine clinical practice and are easily applicable to the medical care and evaluation defined in a trial protocol. However, few clinical pathways are intended to increase the efficiency of clinical trials. Our purpose is to describe the design and development of a new clinical trial process model that enables the primary use of EMRs in clinical trials by integrating clinical pathways and EMRs. We designed a new clinical trial model that uses EMR data directly in clinical trials and developed a system to follow this model. We applied the system to an investigator-initiated clinical trial and examined whether all data were extracted correctly. At the protocol development stage, our model measures endpoints based on clinical pathways with the same diagnosis. Next, medical record descriptions and the format of the statistical data are defined. According to these observations, screens for entry of data, which are used both in clinical practice and for study, are prepared into EMRs with an EMR template, and screens are prepared for data checks on our EMR retrieval system (ERS). In an actual trial, patients are registered and randomly assigned to a protocol treatment. The protocol treatment is executed according to clinical pathways, and the data are recorded to EMRs using EMR templates. The data are checked by a local data manager using reports created by the ERS. After edit checks and corrections, the data are extracted by the ERS, archived in portable document format (PDF) with an electronic signature, and transferred in comma-separated values (CSV) format to a coordinating centre. At the coordinating centre

  6. cluster randomIzed trIal of the uptake of a take-home Infant dose of ...

    African Journals Online (AJOL)

    2010-07-07

    Jul 7, 2010 ... cluster randomIzed trIal of the uptake of a take-home Infant dose of nevIrapIne In kenya. H. W. ReynOldS, O. GACHunO, J. kAyITA, m. A. HAyS and J. RAkWAR, abstract. Objective: to test whether a single take home dose of infant nevirapine increased infant uptake without decreasing institutional deliveries.

  7. Consideration of chronic pain in trials to promote physical activity for diabetes: a systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    John J Riva

    Full Text Available Chronic pain has been estimated to affect 60% of patients with diabetes and is strongly associated with reduced activity tolerance. We systematically reviewed randomized controlled trials (RCTs that explored interventions to improve physical activity among patients with diabetes to establish whether co-morbid chronic pain was captured at baseline or explored as an effect modifier and if trials reported a component designed to target chronic pain.We searched CINAHL, Cochrane Central Registry of Controlled Trials, EMBASE, ERIC, MEDLINE, SPORTDiscus and PsycInfo from inception of each database to March 2012 for RCTs that enrolled patients with diabetes and randomly assigned them to an intervention designed to promote physical activity. Two reviewers independently selected trials and abstracted data. We identified 136 trials meeting our inclusion criteria, only one of which that reported capturing chronic pain measures at baseline. No trial reported on specific interventions to address chronic pain as a competing demand, or as an effect modifier.Only 1 trial identified that aimed to promote physical activity among patients with diabetes reported that co-morbid chronic pain was captured at baseline. No trials reported exploring chronic pain as an effect modifier or targeting it as part of its intervention.

  8. Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial

    DEFF Research Database (Denmark)

    Fröbert, Ole; Götberg, Matthias; Angerås, Oskar

    2017-01-01

    BACKGROUND: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following...... influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. METHODS/DESIGN: The Influenza...... vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly...

  9. Can response-adaptive randomization increase participation in acute stroke trials?

    Science.gov (United States)

    Tehranisa, Jason S; Meurer, William J

    2014-07-01

    A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials. This cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design. A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants. The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants. © 2014 American Heart Association, Inc.

  10. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  11. Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

    NARCIS (Netherlands)

    Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

    2009-01-01

    OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

  12. A randomized trial of Rapid Rhino Riemann and Telfa nasal packs following endoscopic sinus surgery

    NARCIS (Netherlands)

    Cruise, A. S.; Amonoo-Kuofi, K.; Srouji, I.; Kanagalingam, J.; Georgalas, C.; Patel, N. N.; Badia, L.; Lund, V. J.

    2006-01-01

    OBJECTIVES: To compare Telfa with the Rapid Rhino Riemann nasal pack for use following endoscopic sinus surgery. DESIGN: Prospective, randomized, double-blind, paired trial. SETTING: Tertiary otolaryngology hospital. PARTICIPANTS: Forty-five adult patients undergoing bilateral endoscopic sinus

  13. Yoga for persistent fatigue in breast cancer survivors: a randomized controlled trial

    National Research Council Canada - National Science Library

    Bower, Julienne E; Garet, Deborah; Sternlieb, Beth; Ganz, Patricia A; Irwin, Michael R; Olmstead, Richard; Greendale, Gail

    2012-01-01

    .... The authors conducted a 2-group randomized controlled trial to determine the feasibility and efficacy of an Iyengar yoga intervention for breast cancer survivors with persistent post-treatment fatigue...

  14. Sodium Restriction in Patients With CKD : A Randomized Controlled Trial of Self-management Support

    NARCIS (Netherlands)

    Meuleman, Yvette; Hoekstra, Tiny; Dekker, Friedo W.; Navis, Gerjan; Vogt, Liffert; van der Boog, Paul J. M.; Bos, Willem Jan W.; van Montfrans, Gert A.; van Dijk, Sandra

    Background: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. Study Design: Open randomized controlled trial. Setting & Participants: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

  15. RESTORING LOCOMOTION IN SPINAL CORD INJURY: A RANDOMIZED CONTROLLED TRIAL OF THE LION PROCEDURE

    DEFF Research Database (Denmark)

    Elmgreen, Søren Bruno; Forman, Axel; Possover, Marc

    2017-01-01

    that four patients with chronic traumatic spinal cord 153 injury (SCI) regained significant sensory and motor function following this laparoscopic implantation of neuroprosthesis (LION). Our aim is, therefore, to conduct a prospective randomized activecontrolled trial with elaborate neurophysiological...

  16. Preoperative therapeutic exercise in frail elderly scheduled for total hip replacement: A randomized pilot trial

    NARCIS (Netherlands)

    Hoogeboom, T.J.; Dronkers, J.J.; Ende, C.H.M. van den; Oosting, E.; Meeteren, N.L.U. van

    2010-01-01

    Objective: To evaluate the feasibility and preliminary effectiveness of therapeutic exercise before total hip replacement in frail elderly. Design: A single-blind, randomized clinical pilot trial. Setting: Outpatient physiotherapy department. Subjects: Frail elderly with hip osteoarthritis awaiting

  17. Antiarrhythmic effect of statin therapy and atrial fibrillation a meta-analysis of randomized controlled trials

    National Research Council Canada - National Science Library

    Fauchier, Laurent; Pierre, Bertrand; de Labriolle, Axel; Grimard, Caroline; Zannad, Noura; Babuty, Dominique

    2008-01-01

    To improve the evaluation of the possible antiarrhythmic effect of statins, we performed a meta-analysis of randomized trials with statins on the end point of incidence or recurrence of atrial fibrillation (AF...

  18. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic

  19. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  20. Treating major depression with yoga: A prospective, randomized, controlled pilot trial

    National Research Council Canada - National Science Library

    Sudha Prathikanti; Renee Rivera; Ashly Cochran; Jose Gabriel Tungol; Nima Fayazmanesh; Eva Weinmann

    2017-01-01

    .... Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression...

  1. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials

    National Research Council Canada - National Science Library

    Black, David S; Slavich, George M

    2016-01-01

    .... To address this issue, we conducted the first comprehensive review of randomized controlled trials examining the effects of mindfulness meditation on immune system parameters, with a specific focus on five outcomes: (1...

  2. Addition of Lidocaine Injection Immediately before Physiotherapy for Frozen Shoulder: A Randomized Controlled Trial: e0118217

    National Research Council Canada - National Science Library

    Wei-Chun Hsu; Tao-Liang Wang; Yi-Jia Lin; Lin-Fen Hsieh; Chun-Mei Tsai; Kuang-Hui Huang

    2015-01-01

    ..., thus enhancing the treatment effect. To compare the effects of intraarticular injection of lidocaine plus physiotherapy to that of physiotherapy alone in the treatment of a frozen shoulder, a prospective randomized controlled trial...

  3. Addition of lidocaine injection immediately before physiotherapy for frozen shoulder: a randomized controlled trial

    National Research Council Canada - National Science Library

    Hsu, Wei-Chun; Wang, Tao-Liang; Lin, Yi-Jia; Hsieh, Lin-Fen; Tsai, Chun-Mei; Huang, Kuang-Hui

    2015-01-01

    ..., thus enhancing the treatment effect. To compare the effects of intraarticular injection of lidocaine plus physiotherapy to that of physiotherapy alone in the treatment of a frozen shoulder, a prospective randomized controlled trial...

  4. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    Lim, Renly; Liong, Men Long; Leong, Wing Seng; Khan, Nurzalina Abdul Karim; Yuen, Kah Hay

    2015-01-01

    There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence...

  5. Effect of Crisis Plans on Admissions and Emergency Visits: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Ruchlewska, A.; Wierdsma, A.I.; Kamperman, A.; van der Gaag, M.; Smulders, R.; Roosenschoon, B.J.; Mulder, C.L.

    2014-01-01

    Objective: To establish whether patients with a crisis plan had fewer voluntary or involuntary admissions, or fewer outpatient emergency visits, than patients without such a plan. Design: Multicenter randomized controlled trial with two intervention conditions and one control condition.

  6. Client attachment security predicts alliance in a randomized controlled trial of two psychotherapies for bulimia nervosa

    DEFF Research Database (Denmark)

    Folke, Sofie; Daniel, Sarah Ingrid Franksdatter; Poulsen, Stig Bernt

    2016-01-01

    Objective: This study investigated the relation between clients’ attachment patterns and the therapeutic alliance in two psychotherapies for bulimia nervosa. Method: Data derive from a randomized clinical trial comparing cognitive-behavioral therapy and psychoanalytic psychotherapy for bulimia...

  7. A process evaluation of the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial

    National Research Council Canada - National Science Library

    Olstad, Dana Lee; Ball, Kylie; Abbott, Gavin; McNaughton, Sarah A; Le, Ha N D; Ni Mhurchu, Cliona; Pollard, Christina; Crawford, David A

    2016-01-01

    Supermarket Healthy Eating for Life (SHELf) was a randomized controlled trial that operationalized a socioecological approach to population-level dietary behaviour change in a real-world supermarket setting...

  8. Cost-Utility of Bilateral Versus Unilateral Cochlear Implantation in Adults: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Smulders, Y.E.; Zon, A. van; Stegeman, I.; Zanten, G.A.; Rinia, A.B.; Stokroos, R.J.; Free, R.H.; Maat, B.; Frijns, J.H.; Mylanus, E.A.M.; Huinck, W.J.; Topsakal, V.; Grolman, W.

    2016-01-01

    OBJECTIVE: To study the cost-utility of simultaneous bilateral cochlear implantation (CI) versus unilateral CI. STUDY DESIGN: Randomized controlled trial (RCT). SETTING: Five tertiary referral centers. PATIENTS: Thirty-eight postlingually deafened adults eligible for cochlear implantation.

  9. Cost-Utility of Bilateral Versus Unilateral Cochlear Implantation in Adults : A Randomized Controlled Trial

    NARCIS (Netherlands)

    Smulders, Yvette E; van Zon, Alice; Stegeman, Inge; van Zanten, Gijsbert A; Rinia, Albert B; Stokroos, Robert J; Free, Rolien H; Maat, Bert; Frijns, Johan H M; Mylanus, Emmanuel A M; Huinck, Wendy J; Topsakal, Vedat; Grolman, Wilko

    OBJECTIVE: To study the cost-utility of simultaneous bilateral cochlear implantation (CI) versus unilateral CI. STUDY DESIGN: Randomized controlled trial (RCT). SETTING: Five tertiary referral centers. PATIENTS: Thirty-eight postlingually deafened adults eligible for cochlear implantation.

  10. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Engers, AJ; Wensing, M.; van Tulder, M.; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN.: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES.: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence

  11. Interactive multimedia consent for biobanking: a randomized trial.

    Science.gov (United States)

    Simon, Christian M; Klein, David W; Schartz, Helen A

    2016-01-01

    The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

  12. Interactive multimedia consent for biobanking: A randomized trial

    Science.gov (United States)

    Simon, Christian M.; Klein, David W.; Schartz, Helen A.

    2015-01-01

    Purpose Interactive multimedia’s potential to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence of understanding of informed consent, compared to a standard, face-to-face (F2F) biobank consent process. Methods A 2 (F2F versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the Biobank’s 9-page consent document. Results Interactivity (F(1,196)=7.56, p=0.007, partial η2=0.037) and Media (F(1,196)=4.27, p=0.04, partial η2=0.021) independently improved participants’ understanding of the Biobank consent. Interactivity (F(1,196) = 6.793, p = 0.01, partial η2=0.033), but not Media (F(1,196) = 0.455, n.s.), resulted in increased participant confidence in their understanding of the Biobank’s consent. Patients took more time to complete the multimedia (M=18.2 min.) than the F2F (M=12.6 min.) conditions. Conclusion This study demonstrated that interactivity and multimedia each can be effective at promoting individuals’ understanding and confidence in understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather separate the two constructs when studying electronic consent. PMID:25834945

  13. Consideration Of Chronic Pain In Trials To Promote Physical Activity For Diabetes: A Systematic Review Of Randomized Controlled Trials

    OpenAIRE

    Riva, John J.; Wong, Jessica J.; Brunarski, David J.; Chan, Alice H. Y.; Lobo, Rebecca A.; Aptekman, Marina; Alabousi, Mostafa; Imam, Maha; Gupta, Anita; Busse, Jason W.

    2013-01-01

    Background Chronic pain has been estimated to affect 60% of patients with diabetes and is strongly associated with reduced activity tolerance. We systematically reviewed randomized controlled trials (RCTs) that explored interventions to improve physical activity among patients with diabetes to establish whether co-morbid chronic pain was captured at baseline or explored as an effect modifier and if trials reported a component designed to target chronic pain. Methodology/principal Findings We ...

  14. Systematic review: The relation between nutrition and nosocomial pneumonia: randomized trials in critically ill patients

    OpenAIRE

    Cook, Deborah; De Jonghe, Bernard; Heyland, Daren

    1997-01-01

    Objective To review the effect of enteral nutrition on nosocomial pneumonia in critically ill patients as summarized in randomized clinical trials. Study identification and selection Studies were identified through MEDLINE, SCISEARCH, EMBASE, the Cochrane Library, bibliographies of primary and review articles, and personal files. Through duplicate independent review, we selected randomized trials evaluating approaches to nutrition and their relation to nosocomial pneumonia. Data abstraction I...

  15. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    OpenAIRE

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Onl...

  16. Platelet-rich fibrin versus albumin in surgical wound repair: a randomized trial with paired design

    DEFF Research Database (Denmark)

    Danielsen, Patricia L; Ågren, Sven Per Magnus; Jørgensen, Lars Nannestad

    2010-01-01

    To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial.......To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial....

  17. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    Science.gov (United States)

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  18. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

    Science.gov (United States)

    Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael

    2016-04-01

    Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial.

    Science.gov (United States)

    Moss, David A; Crawford, Paul

    2015-01-01

    Sore throat is a common cause of pain in outpatient encounters. Battlefield auricular acupuncture (the placing of needles in specific points in the ear) is a modality used to treat acute pain associated with a variety of ailments. The aim of our study was to determine whether auricular acupuncture reduces pain, medication usage, and missed work hours when added to standard therapy in adult patients with acute sore throat. We conducted an unblinded, pragmatic, randomized controlled trial among adult, nonpregnant patients presenting to an Air Force family medicine clinic with pain from acute sore throat. A total of 54 patients were followed for 48 hours after treatment. Patients receiving auricular acupuncture reported lower pain scores than those who did not at 15 minutes (6.0 [95% confidence interval (CI), 5.4-6.6] vs 2.6 [95% CI, 1.7-3.5]; P vs 2.5 [95% CI, 1.6-3.4]; P = .0005), and 24 hours (4.1 [95% CI, 3.3-4.9] vs 1.3 [95% CI, 1.0-2.8]; P = .0006). They also reported taking fewer cumulative doses of pain medication at 6 hours (1.07 [95% CI, 0.69-1.45] vs 0.39 [95% CI, 0.2-0.58]; P = .003), 24 hours (2.63 [95% CI, 1.95-3.31] vs 1.37 [95% CI, 0.92-1.82]; P = .004), and 48 hours (4.07 [95% CI, 2.9-5.24] vs 2.19 [95% CI, 1.44-2.94]; P = .009). There was no difference in time missed from work between the auricular acupuncture and standard therapy groups. Compared with usual treatment, battlefield auricular acupuncture was associated with reduced sore throat pain for 24 hours and decreased use of pain medication for up to 48 hours. There was no apparent effect on hours missed from work. © Copyright 2015 by the American Board of Family Medicine.

  20. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial.

    Science.gov (United States)

    Wu, Susan; Baker, Chris; Lang, Michael E; Schrager, Sheree M; Liley, Fasha F; Papa, Carmel; Mira, Valerie; Balkian, Ara; Mason, Wilbert H

    2014-07-01

    Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Previous studies have shown a potential benefit of nebulized hypertonic saline; however, its effect in the emergency department (ED) setting is unclear. To compare the effect of nebulized 3% hypertonic saline vs 0.9% normal saline on admission rate and length of stay in infants with bronchiolitis. We conducted a double-blind, randomized clinical trial during 3 consecutive bronchiolitis seasons from March 1, 2008, through April 30, 2011. We recruited a convenience sample of patients younger than 24 months with a primary diagnosis of viral bronchiolitis presenting to the ED of 2 urban free-standing tertiary children's hospitals. We excluded patients who were premature (gestational age, saline [HS group]) or 0.9% sodium chloride (normal saline [NS group]) inhaled as many as 3 times in the ED. Those admitted received the assigned medication every 8 hours until discharge. All treatment solutions were premedicated with albuterol sulfate. Hospital admission rate, length of stay for admitted patients, and Respiratory Distress Assessment Instrument score. A total of 197 patients were enrolled in the NS group and 211 in the HS group. Admission rate in the 3% HS group was 28.9% compared with 42.6% in the NS group (adjusted odds ratio from logistic regression, 0.49 [95% CI, 0.28-0.86]). Mean (SD) length of stay for hospitalized patients was 3.92 (5.24) days for the NS group and 3.16 (2.11) days for the HS group (P = .24). The Respiratory Distress Assessment Instrument score decreased after treatment in both groups; however, we found no significant difference between groups (P = .35). Hypertonic saline given to children with bronchiolitis in the ED decreases hospital admissions. We can detect no significant difference in Respiratory Distress Assessment Instrument score or length of stay between the HS and NS groups. clinicaltrials.gov Identifier: NCT00619918.

  1. Porcine collagen matrix for treating gingival recession. Randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Yuri Castro

    2014-03-01

    Full Text Available Achieving root coverage after exposure caused by gingival recession is one of the main goals of reconstructive periodontal surgery. Even though a large variety of techniques and mucogingival grafting procedures are available, their long-term results are not clear yet. Therefore, this study aimed to compare clinical effectiveness of the porcine collagen matrix with subepithelial connective graft for treating Miller class I and II gingival recessions. Materials and methods: The randomized clinical trial included twelve patients assigned to two groups. In the first group (experimental, six patients were treated using collagen matrix (mean age, 54.3±5.6 years; mean recession 2. 67±1.03mm. Another group (control of six patients was treated using connective grafts (mean age, 57.1± 2.7 years; mean recession 4.33±1.03mm. All patients underwent periodontal evaluation and pre-surgical preparation including oral hygiene instruction and supragingival scaling. Gingival recessions were exposed through partial thickness flaps where the grafts and matrices were placed. Patients were assessed periodically until complete healing of tissue. Results: Root coverage parameters, amount of keratinized gingiva, gingival biotype and clinical attachment level were evaluated. The root coverage percentage for the group using connective graft was 24.7±13.5% and 16.6±26.8% for the one treated with the matrix. The amount of increased keratinized tissue was 4.33±2.06mm and 4.5±0.83mm for the control and experimental group respectively. Both groups increased gingival biotypes from thin to thick at 100%. The final clinical attachment level was 4.17±3.17±04mm for the control group and 0.98mm for the experimental group. There were significant differences between the outcome of gingival recession and clinical attachment. Conclusion: Results indicate both techniques, besides being predictable, are useful for improving clinical parameters when treating gingival recessions

  2. [A systematic review of randomized controlled clinical trials of abdominal acupuncture treatment of cervical spondylosis].

    Science.gov (United States)

    Wang, Yan-wen; Fu, Wen-bin; Ou, Ai-hua; Fan, Ling; Huang, Ye-fei

    2011-04-01

    To assess the effect and methodological quality of clinically randomized controlled studies on abdominal acupuncture therapy for cervical spondylosis and to make out its current situation, validity and applicability. Using the PubMed, CNKI (China Academic Journals Full-text Database), VIP (VIP Chinese Science and Technology Periodicals Database) and Wanfang Digital Periodicals Electronic Database covering the period of 1989-2009, we did a literature search on the original articles of abdominal acupuncture treatment of cervical spondylosis and selected those accorded with the standards of randomized controlled studies. Animal studies, surveys, and news articles, and those duplicated, being absent in diagnostic criteria and non-randomized controlled trials were excluded. The papers' quality was analyzed by using the Jadad quality assessment scoring system and the therapeutic effect evaluated by using Review Manage 4.2.7 software. A total of 8 papers containing 909 cervical spondylosis patients and written in Chinese were included. These 8 studies used the effective rate as the primary outcome, 2 of them used the McGill Pain Questionnaire scales at the same time. Meta-analysis showed that the abdominal acupuncture group was better than the control group in visual analogue scale score (P acupuncture and routine acupuncture [OR = 3.29, 95% CI (0.13, 82.99)], EA [OR = 2.09, 95% CI (0.36, 11.95)] and traction therapy [OR = 6.06, 95% CI (3.01, 12.18)] in the total effective rate, pain rating index score [WMD = -2.24, 95% CI (-5.29, 0.81)] and the present pain intensity score [WMD = -0.84, 95% CI (-2.13, 0.44)]. At the present, there has been no sufficient evidence to ensure that in the treatment of cervical spondylosis, the abdominal acupuncture therapy is superior to routine acupuncture, EA and traction therapy. Attention should be paid to the randomized controlled study of larger samples and qualified design.

  3. Assessment of risk of bias in randomized clinical trials in surgery

    DEFF Research Database (Denmark)

    Gurusamy, K S; Gluud, C; Nikolova, D

    2009-01-01

    BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...... in surgical trials as described by The Cochrane Collaboration, and the methods that can be used to avoid them, are reviewed. RESULTS: Blinding is difficult in many surgical trials but careful trial design can reduce the bias risk due to lack of blinding. It is possible to conduct surgical trials with low risk...... of bias by using appropriate trial design. CONCLUSION: The risk of providing a treatment based on a biased effect estimate must be balanced against the difficulty of conducting trials with very low risk of bias. Better understanding of the risk of bias may result in improved trials with a closer estimate...

  4. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Brown, Benjamin; Lystad, Reidar P

    2016-09-01

    Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately. This study aimed to describe the extent of adverse events reporting in published RCTs involving SMT, and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement. This is a systematic literature review. The Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analyzed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analyzed using tests for equality of proportions with continuity correction. There was no funding obtained for this study. The authors declare no conflict of interest. Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events

  5. Reporting adverse events in randomized controlled trials in periodontology: a systematic review.

    Science.gov (United States)

    Faggion, Clovis M; Tu, Yu-Kang; Giannakopoulos, Nikolaos N

    2013-09-01

    Reporting of adverse events is of paramount importance in randomized controlled trials (RCTs) to guide the implementation of new therapeutic approaches in clinical practice. The aim of this study was to assess the quality of adverse events reporting in RCTs published in the periodontal literature. Two authors (CMF and NNG) searched the PubMed and LILACS electronic databases independently and in duplicate to identify RCTs published in periodontology from 2002 to 2003 and from 2011 to 2012. Reporting quality in RCTs was assessed with reference to the 2004 CONSORT Extension for Harms checklist. Differences in adverse events reporting between industry- and non-industry-funded RCTs were also determined. Cohen's kappa statistic was used to determine the extent of inter-reviewer agreement. Fischer's exact test was used to assess differences in reporting between the two samples. The analysis included 246 publications. One hundred twenty-four of 990 (13%) items and 223 of 1460 (15%) items were adequately reported in publications from 2002 to 2003 and from 2011 to 2012 respectively. Three checklist topics were significantly better reported in the 2011-2012 sample; two recommendations were better reported in non-industry-funded trials in publications from both periods. Improvement and standardization of adverse events reporting in periodontology are needed. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. A randomized, controlled trial of in-home drinking water intervention to reduce gastrointestinal illness.

    Science.gov (United States)

    Colford, John M; Wade, Timothy J; Sandhu, Sukhminder K; Wright, Catherine C; Lee, Sherline; Shaw, Susan; Fox, Kim; Burns, Susan; Benker, Anne; Brookhart, M Alan; van der Laan, Mark; Levy, Deborah A

    2005-03-01

    Trials have provided conflicting estimates of the risk of gastrointestinal illness attributable to tap water. To estimate this risk in an Iowa community with a well-run water utility with microbiologically challenged source water, the authors of this 2000-2002 study randomly assigned blinded volunteers to use externally identical devices (active device: 227 households with 646 persons; sham device: 229 households with 650 persons) for 6 months (cycle A). Each group then switched to the opposite device for 6 months (cycle B). The active device contained a 1-microm absolute ceramic filter and used ultraviolet light. Episodes of "highly credible gastrointestinal illness," a published measure of diarrhea, nausea, vomiting, and abdominal cramps, were recorded. Water usage was recorded with personal diaries and an electronic totalizer. The numbers of episodes in cycle A among the active and sham device groups were 707 and 672, respectively; in cycle B, the numbers of episodes were 516 and 476, respectively. In a log-linear generalized estimating equations model using intention-to-treat analysis, the relative rate of highly credible gastrointestinal illness (sham vs. active) for the entire trial was 0.98 (95% confidence interval: 0.86, 1.10). No reduction in gastrointestinal illness was detected after in-home use of a device designed to be highly effective in removing microorganisms from water.

  7. The effects of probiotics on total cholesterol: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Lang; Guo, Mao-Juan; Gao, Qing; Yang, Jin-Feng; Yang, Lin; Pang, Xiao-Li; Jiang, Xi-Juan

    2018-02-01

    Probiotics supplements provide a new nonpharmacological alternative to reduce cardiovascular risk factors. The impact of probiotics on the reduction of total cholesterol (TC) remains controversial. We conducted a meta-analysis to showcase the most updated and comprehensive evaluation of the studies. Randomized controlled trials (RCTs) were searched from electronic databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang database dating from January 2007 to January 2017. The curative effects of probiotics on the reduction of TC were assessed using mean difference (MD), as well as their 95% confidence interval (CI). RevMan software (version 5.3) was used to carry out this meta-analysis. Thirty-two RCTs including 1971 patients met the inclusion criteria. Results of this analysis showed that compared with the control group serum TC was significantly reduced in probiotics group [MD = -13.27, 95% CI (-16.74 to 9.80), P  6 weeks: [MD = -22.18, 95% CI (-28.73, -15.63), P probiotics forms and intervention duration might have a significant impact on the results. However, strains and doses of probiotics had no significant influence on curative effects. Available evidence indicates that probiotics supplements can significantly reduce serum TC. Furthermore, higher baseline TC, longer intervention time, and probiotics in capsules form might contribute to a better curative effect.

  8. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research.

    Science.gov (United States)

    Press, William H

    2009-12-29

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case--the two-armed Bernoulli bandit problem--can be exactly optimized for a variety of ethically motivated cost functions that embody principles of duty-to-patient, but the solutions have been thought computationally infeasible when the numbers of patients in the study (the "horizon") is large. We report numerical experiments that yield a heuristic approximation that applies even to very large horizons, and we propose a near-optimal strategy that remains valid even when the horizon is unknown or unbounded, thus applicable to comparative effectiveness studies on large populations or to standard-of-care recommendations. For the case in which the economic cost of treatment is a parameter, we give a heuristic, near-optimal strategy for determining the superior treatment (whether more or less costly) while minimizing resources wasted on any inferior, more expensive, treatment. Key features of our heuristics can be generalized to more complicated protocols.

  9. Effective Recruitment of Schools for Randomized Clinical Trials: Role of School Nurses.

    Science.gov (United States)

    Petosa, R L; Smith, L

    2017-01-01

    In school settings, nurses lead efforts to improve the student health and well-being to support academic success. Nurses are guided by evidenced-based practice and data to inform care decisions. The randomized controlled trial (RCT) is considered the gold standard of scientific rigor for clinical trials. RCTs are critical to the development of evidence-based health promotion programs in schools. The purpose of this article is to present practical solutions to implementing principles of randomization to RCT trials conducted in school settings. Randomization is a powerful sampling method used to build internal and external validity. The school's daily organization and educational mission provide several barriers to randomization. Based on the authors' experience in conducting school-based RCTs, they offer a host of practical solutions to working with schools to successfully implement randomization procedures. Nurses play a critical role in implementing RCTs in schools to promote rigorous science in support of evidence-based practice.

  10. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

    Directory of Open Access Journals (Sweden)

    Thomson Denise

    2010-12-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results Most studies (83% were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008. Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25. Among survey respondents (50% response rate, the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

  11. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  12. The effects of motivation feedback in patients with severe mental illness: A cluster randomized controlled trial

    NARCIS (Netherlands)

    E.C. Jochems (Eline); C.M. van der Feltz-Cornelis (Christina); A. van Dam (Arno); H.J. Duivenvoorden (Hugo); C.L. Mulder (Niels)

    2015-01-01

    textabstractObjective: To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness.Methods: Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968).

  13. Reporting of positive results in randomized controlled trials of mindfulness-based mental health interventions

    NARCIS (Netherlands)

    Coronado-Montoya, S.; Levis, A.W.; Kwakkenbos, C.M.C.; Steele, R.J.; Turner, E.H.; Thombs, B.D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of

  14. The cyclical lower extremity exercise for Parkinson's trial (CYCLE): methodology for a randomized controlled trial.

    Science.gov (United States)

    Rosenfeldt, Anson B; Rasanow, Matthew; Penko, Amanda L; Beall, Erik B; Alberts, Jay L

    2015-04-24

    Motor and non-motor impairments affect quality of life in individuals with Parkinson's disease. Our preliminary research indicates that forced exercise cycling, a mode of exercise in which a participant's voluntary rate of exercise is augmented on a stationary cycle, results in global improvements in the cardinal symptoms of Parkinson's disease. The objective of the Cyclical Lower Extremity Exercise (CYCLE) trial for Parkinson's disease is to determine the effects of forced exercise cycling on motor and non-motor performance when compared to voluntary rate cycling and a non-exercise control group. Additionally, we plan to identify any associated changes in neural activity determined by functional magnetic resonance imaging. A total of 100 individuals with mild to moderate idiopathic Parkinson's disease will participate in a single-center, parallel-group, rater-blind study. Participants will be randomized 2:2:1 into a forced exercise, voluntary exercise, or no-exercise control group, respectively. Both exercise groups will cycle 3 times per week for 8 weeks at identical aerobic intensities for 40 minutes, but participants in the forced exercise group will cycle 30% faster than their voluntary rate by means of an augmented motorized bicycle. Neuroimaging, clinical, and biomechanical assessments of motor and non-motor performance will be made at baseline both 'on' and 'off' medication, after four weeks of exercise (midpoint), end of treatment, 4 weeks after end of treatment, and 8 weeks after end of treatment. CYCLE trial will play a critical role in determining the effectiveness of two different types of aerobic exercise, forced and voluntary, on motor and non-motor performance in individuals with Parkinson's disease. Additionally, the coupling of clinical, biomechanical, and neuroimaging outcomes has the potential to provide insight into mechanisms underlying change in function as a result of exercise. Clinicaltrials.gov registration number NCT01636297.

  15. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial

    OpenAIRE

    Mummah, Sarah; Robinson, Thomas N.; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D.

    2017-01-01

    Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Methods Overweight adults (n=135) aged 18?50 years with BMI=28?40 kg/m2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) an...

  16. Fool’s gold, lost treasures, and the randomized clinical trial

    Science.gov (United States)

    2013-01-01

    Background Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. Discussion A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are “equivalent” despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that “shot-gun” combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without

  17. Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial.

    Science.gov (United States)

    Santos, Ina S; Bassani, Diego G; Matijasevich, Alicia; Halal, Camila S; Del-Ponte, Bianca; da Cruz, Suélen Henriques; Anselmi, Luciana; Albernaz, Elaine; Fernandes, Michelle; Tovo-Rodrigues, Luciana; Silveira, Mariangela F; Hallal, Pedro C

    2016-09-02

    Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants. The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months. The negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in

  18. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  19. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  20. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  1. The efficacy of resiliency training programs: a systematic review and meta-analysis of randomized trials.

    Directory of Open Access Journals (Sweden)

    Aaron L Leppin

    Full Text Available Poor mental health places a burden on individuals and populations. Resilient persons are able to adapt to life's challenges and maintain high quality of life and function. Finding effective strategies to bolster resilience in individuals and populations is of interest to many stakeholders.To synthesize the evidence for resiliency training programs in improving mental health and capacity in 1 diverse adult populations and 2 persons with chronic diseases.Electronic databases, clinical trial registries, and bibliographies. We also contacted study authors and field experts.Randomized trials assessing the efficacy of any program intended to enhance resilience in adults and published after 1990. No restrictions were made based on outcome measured or comparator used.Reviewers worked independently and in duplicate to extract study characteristics and data. These were confirmed with authors. We conducted a random effects meta-analysis on available data and tested for interaction in planned subgroups.The standardized mean difference (SMD effect of resiliency training programs on 1 resilience/hardiness, 2 quality of life/well-being, 3 self-efficacy/activation, 4 depression, 5 stress, and 6 anxiety.We found 25 small trials at moderate to high risk of bias. Interventions varied in format and theoretical approach. Random effects meta-analysis showed a moderate effect of generalized stress-directed programs on enhancing resilience [pooled SMD 0.37 (95% CI 0.18, 0.57 p = .0002; I2 = 41%] within 3 months of follow up. Improvement in other outcomes was favorable to the interventions and reached statistical significance after removing two studies at high risk of bias. Trauma-induced stress-directed programs significantly improved stress [-0.53 (-1.04, -0.03 p = .03; I2 = 73%] and depression [-0.51 (-0.92, -0.10 p = .04; I2 = 61%].We found evidence warranting low confidence that resiliency training programs have a small to moderate effect at

  2. What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

    Science.gov (United States)

    Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

    2012-06-01

    In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association

  3. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2011-01-01

    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  4. Exercise improves cardiorespiratory fitness in people with depression: A meta-analysis of randomized control trials.

    Science.gov (United States)

    Stubbs, Brendon; Rosenbaum, Simon; Vancampfort, Davy; Ward, Philip B; Schuch, Felipe B

    2016-01-15

    Cardiorespiratory fitness (CRF) is an independent predictor of cardiovascular disease and all-cause mortality. CRF improves in response to exercise interventions, yet the effectiveness of such interventions to improve CRF among people with depression is unclear. We conducted a systematic review and meta-analysis to evaluate whether CRF improves in people with depression in exercise randomized control trials (RCTs). Three authors identified RCTs from a recent Cochrane review and conducted updated searches of major electronic databases. We included RCTs of exercise interventions in people with depression (including major depressive disorder (MDD) and above-threshold depressive symptoms) that reported CRF (defined as predicted maximal oxygen uptake (VO2max predicted) or peak oxygen uptake (VO2peak)) versus a control condition. A random effects meta-analysis was conducted. Seven unique RCTs including 8 aerobic exercise interventions for depression were eligible, including 293 people allocated to exercise (mean age=40.3 years, range=27.2-64.7 years and 35-100% female) and 205 allocated to control conditions. Across all studies exercise results in a significant increase in CRF (g=0.64, 95%CI=0.32-0.96, pdepression can achieve clinically relevant improvements in CRF in response to exercise interventions. Targeting 'fitness' rather than 'fatness' may be another feasible intervention strategy in this population. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Randomized trial of a peer resistance skill-building game for Hispanic early adolescent girls.

    Science.gov (United States)

    Norris, Anne E; Hughes, Charles; Hecht, Michael; Peragallo, Nilda; Nickerson, David

    2013-01-01

    Adolescents can use peer resistance skills to avoid being pressured into risky behavior, such as early sexual behavior. Avatar-based virtual reality technology offers a novel way to help build these skills. The aims of this study were to evaluate the feasibility of an avatar-based virtual reality peer resistance skill building game (DRAMA-RAMA), to explore the impact of game play on peer resistance self-efficacy, and to assess how positively the game was perceived. Forty-four low-income early adolescent Hispanic girls were assigned randomly to either the intervention (DRAMA-RAMA) or attention control game (Wii Dancing With the Stars) condition. All participants were offered a five-session curriculum that included peer resistance skill content before playing their respective game for 15 minutes, once a week, for 2 weeks. Participants completed electronic surveys at baseline, after game play, and at 2 months to assess demographics, peer resistance self-efficacy, and sexual behavior. They also completed a paper-pencil game experience questionnaire immediately after game play. Data were analyzed using descriptive statistics, t test, chi-square, and analyses of covariance. Separate analyses of covariance showed a significant game effect at posttest for the peer resistance self-efficacy measure (F = 4.21, p .26). This randomized control trial provides preliminary support for the hypothesis that playing an avatar-based virtual reality technology game can strengthen peer resistance skills, and early adolescent Hispanic girls will have a positive response to this game.

  6. DO IT Trial: vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial.

    Science.gov (United States)

    Maguire, Jonathon L; Birken, Catherine S; Loeb, Mark B; Mamdani, Muhammad; Thorpe, Kevin; Hoch, Jeffrey S; Mazzulli, Tony; Borkhoff, Cornelia M; Macarthur, Colin; Parkin, Patricia C

    2014-02-08

    Vitamin D levels are alarmingly low (respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI. This study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups. Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and

  7. Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Acin, Francisco; de Haro, Joaquin; Bleda, Silvia; Varela, Cesar; Esparza, Leticia

    2012-10-01

    To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials. A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI). The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1

  8. Acupoint Stimulation for Acne: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Cao, Hui-Juan; Yang, Guo-Yan; Wang, Yu-Yi; Liu, Jian-Ping

    2013-06-01

    Acupoint stimulation-including acupuncture, moxibustion, cupping, acupoint injection, and acupoint catgut embedding-has shown a beneficial effect for treating acne. However, comprehensive evaluation of current clinical evidence is lacking. The aim of this review was to assess the effectiveness and safety of all acupoint stimulation techniques used to treat acne vulgaris. A systematic review was conducted. It included only randomized controlled trials on acupoint stimulation for acne. Six electronic databases were searched for English and Chinese language studies. All searches ended in May 2012. Studies were selected for eligibility and assessed for quality. RevMan 5.1 software was used for data analysis with an effect estimate presented as risk ratios (RR) or mean difference (MD) with a 95% confidence interval (CI). Studies with subjects who were diagnosed with acne vulgaris, or papulopustular, inflammatory, adolescent, or polymorphic acne-regardless of gender, age, and ethnicity-were included. Interventions included any acupoint stimulation technique-such as acupuncture, moxibustion, cupping, acupoint injection, and acupoint catgut embedding-compared with no treatment, placebo, or conventional pharmaceutical m