Sample records for active comparator trials

  1. Physical activity and trial-by-trial adjustments of response conflict.

    PubMed

    Kamijo, Keita; Takeda, Yuji

    2013-08-01

    The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

  2. Comparative costs and activity from a sample of UK clinical trials units.

    PubMed

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  3. Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

    PubMed

    Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

    2016-04-01

    Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

  4. The Effects of Industry Sponsorship on Comparator Selection in Trial Registrations for Neuropsychiatric Conditions in Children

    PubMed Central

    Dunn, Adam G.; Mandl, Kenneth D.; Coiera, Enrico; Bourgeois, Florence T.

    2013-01-01

    Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

  5. The effects of industry sponsorship on comparator selection in trial registrations for neuropsychiatric conditions in children.

    PubMed

    Dunn, Adam G; Mandl, Kenneth D; Coiera, Enrico; Bourgeois, Florence T

    2013-01-01

    Pediatric populations continue to be understudied in clinical drug trials despite the increasing use of pharmacotherapy in children, particularly with psychotropic drugs. Most pertinent to the clinical selection of drug interventions are trials directly comparing drugs against other drugs. The aim was to measure the prevalence of active drug comparators in neuropsychiatric drug trials in children and identify the effects of funding source on comparator selection. We analyzed the selection of drugs and drug comparisons in clinical trials registered between January 2006 and May 2012. Completed and ongoing interventional trials examining treatments for six neuropsychiatric conditions in children were included. Networks of drug comparisons for each condition were constructed using information about the trial study arms. Of 421 eligible trial registrations, 228 (63,699 participants) were drug trials addressing ADHD (106 trials), autism spectrum disorders (47), unipolar depression (16), seizure disorders (38), migraines and other headaches (15), or schizophrenia (11). Active drug comparators were used in only 11.0% of drug trials while 44.7% used a placebo control and 44.3% no drug or placebo comparator. Even among conditions with well-established pharmacotherapeutic options, almost all drug interventions were compared to a placebo. Active comparisons were more common among trials without industry funding (17% vs. 8%, p=0.04). Trials with industry funding differed from non-industry trials in terms of the drugs studied and the comparators selected. For 73% (61/84) of drugs and 90% (19/21) of unique comparisons, trials were funded exclusively by either industry or non-industry. We found that industry and non-industry differed when choosing comparators and active drug comparators were rare for both groups. This gap in pediatric research activity limits the evidence available to clinicians treating children and suggests a need to reassess the design and funding of pediatric

  6. Decline in placebo-controlled trial results suggests new directions for comparative effectiveness research.

    PubMed

    Olfson, Mark; Marcus, Steven C

    2013-06-01

    The Affordable Care Act offers strong support for comparative effectiveness research, which entails comparisons among active treatments, to provide the foundation for evidence-based practice. Traditionally, a key form of research into the effectiveness of therapeutic treatments has been placebo-controlled trials, in which a specified treatment is compared to placebo. These trials feature high-contrast comparisons between treatments. Historical trends in placebo-controlled trials have been evaluated to help guide the comparative effectiveness research agenda. We investigated placebo-controlled trials reported in four leading medical journals between 1966 and 2010. We found that there was a significant decline in average effect size or average difference in efficacy (the ability to produce a desired effect) between the active treatment and placebo. On average, recently studied treatments offered only small benefits in efficacy over placebo. A decline in effect sizes in conventional placebo-controlled trials supports an increased emphasis on other avenues of research, including comparative studies on the safety, tolerability, and cost of treatments with established efficacy.

  7. Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

    PubMed

    Luce, Bryan R; Connor, Jason T; Broglio, Kristine R; Mullins, C Daniel; Ishak, K Jack; Saunders, Elijah; Davis, Barry R

    2016-09-20

    Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs. To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research. Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design. Comparative effectiveness trial of antihypertensive medications. Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data. Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions. The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier. This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered. In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups. National Heart, Lung, and Blood Institute.

  8. Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus.

    PubMed

    Connor, Jason T; Elm, Jordan J; Broglio, Kristine R

    2013-08-01

    We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).

    PubMed

    James, Erica L; Ewald, Ben; Johnson, Natalie; Brown, Wendy; Stacey, Fiona G; Mcelduff, Patrick; Booth, Angela; Yang, Fan; Hespe, Charlotte; Plotnikoff, Ronald C

    2014-12-29

    Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed. This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior

  10. The ACTIVATE study: results from a group-randomized controlled trial comparing a traditional worksite health promotion program with an activated consumer program.

    PubMed

    Terry, Paul E; Fowles, Jinnet Briggs; Xi, Min; Harvey, Lisa

    2011-01-01

    PURPOSE. This study compares a traditional worksite-based health promotion program with an activated consumer program and a control program DESIGN. Group randomized controlled trial with 18-month intervention. SETTING. Two large Midwestern companies. SUBJECTS. Three hundred and twenty employees (51% response). INTERVENTION. The traditional health promotion intervention offered population-level campaigns on physical activity, nutrition, and stress management. The activated consumer intervention included population-level campaigns for evaluating health information, choosing a health benefits plan, and understanding the risks of not taking medications as prescribed. The personal development intervention (control group) offered information on hobbies. The interventions also offered individual-level coaching for high risk individuals in both active intervention groups. MEASURES. Health risk status, general health status, consumer activation, productivity, and the ability to evaluate health information. ANALYSIS. Multivariate analyses controlled for baseline differences among the study groups. RESULTS. At the population level, compared with baseline performance, the traditional health promotion intervention improved health risk status, consumer activation, and the ability to recognize reliable health websites. Compared with baseline performance, the activated consumer intervention improved consumer activation, productivity, and the ability to recognize reliable health websites. At the population level, however, only the activated consumer intervention improved any outcome more than the control group did; that outcome was consumer activation. At the individual level for high risk individuals, both traditional health coaching and activated consumer coaching positively affected health risk status and consumer activation. In addition, both coaching interventions improved participant ability to recognize a reliable health website. Consumer activation coaching also

  11. Modifying the clinical research infrastructure at a dedicated clinical trials unit: assessment of trial development, activation, and participant accrual

    PubMed Central

    Tang, Chad; Hess, Kenneth R.; Sanders, Dwana; Davis, Suzanne; Buzdar, Aman; Kurzrock, Razelle; Lee, J. Jack; Meric-Bernstam, Funda; Hong, David

    2017-01-01

    Purpose Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. Experimental Design Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results We identified 3 facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship (industry [133 ICT and 133 non-ICT trials] or institutional [68 ICT and 68 non-ICT trials]). ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrollment (median difference of 0.3 months for industry vs. 1.2 months for institutional) (all matched P<0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional) (all matched P<0.05). Conclusions Use of a clinical research–focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. PMID:27852698

  12. Transforming the Activation of Clinical Trials.

    PubMed

    Watters, Julie T; Pitzen, Jason H; Sanders, Linda J; Bruce, Virginia Nickie M; Cornell, Alissa R; Cseko, Gary C; Grace, Janice S; Kwon, Pamela S; Kukla, Andrea K; Lee, Michael S; Monosmith, Michelle D; Myren, John D; Kottschade, Rebecca S; Shaft, Marc N; Weis, Jennifer Jenny A; Welter, Jane C; Bharucha, Adil E

    2018-01-01

    The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  13. Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.

    PubMed

    Tang, Chad; Hess, Kenneth R; Sanders, Dwana; Davis, Suzanne E; Buzdar, Aman U; Kurzrock, Razelle; Lee, J Jack; Meric-Bernstam, Funda; Hong, David S

    2017-03-15

    Purpose: Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center (Houston, TX) and analyzed their effects on the trial activation timeline and enrolment. Experimental Design: Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database, we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results: We identified three facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship [industry (133 ICT and 133 non-ICT trials) or institutional (68 ICT and 68 non-ICT trials)]. ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrolment (median difference of 0.3 months for industry vs. 1.2 months for institutional; all matched P < 0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional; all matched P < 0.05). Conclusions: Use of a clinical research-focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual. Clin Cancer Res; 23(6); 1407-13. ©2016 AACR . ©2016 American Association for Cancer Research.

  14. Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

    PubMed

    Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

    2016-08-22

    Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention

  15. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial.

    PubMed

    Geladé, Katleen; Janssen, Tieme W P; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-10-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally titrated methylphenidate and (2) a semi-active control intervention, physical activity, to account for nonspecific effects. A multicenter 3-way parallel-group study with balanced randomization was conducted. Children with a DSM-IV-TR diagnosis of ADHD, aged 7-13 years, were randomly allocated to receive neurofeedback (n = 39), methylphenidate (n = 36), or physical activity (n = 37) over a period of 10-12 weeks. Neurofeedback comprised theta/beta training on the vertex (Cz). Physical activity consisted of moderate to vigorous intensity exercises. Neurofeedback and physical activity were balanced in terms of number (~30) and duration of sessions. A double-blind pseudorandomized placebo-controlled crossover titration procedure was used to determine an optimal dose in the methylphenidate intervention. Parent and teacher ratings on the Strengths and Difficulties Questionnaire (SDQ) and Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) were used to assess intervention outcomes. Data collection took place between September 2010 and March 2014. Intention-to-treat analyses revealed an improvement in parent-reported behavior on the SDQ and the SWAN Hyperactivity/Impulsivity scale, irrespective of received intervention (ηp² = 0.21-0.22, P ≤ .001), whereas the SWAN Inattention scale revealed more improvement in children who received methylphenidate than neurofeedback and physical activity (ηp² = 0.13, P ≤ .001). Teachers reported a decrease of ADHD symptoms on all measures for methylphenidate, but not for neurofeedback or physical activity (range of ηp² = 0.14-0.29, P < .001). The current study found that optimally titrated methylphenidate is superior to

  16. Selecting promising treatments in randomized Phase II cancer trials with an active control.

    PubMed

    Cheung, Ying Kuen

    2009-01-01

    The primary objective of Phase II cancer trials is to evaluate the potential efficacy of a new regimen in terms of its antitumor activity in a given type of cancer. Due to advances in oncology therapeutics and heterogeneity in the patient population, such evaluation can be interpreted objectively only in the presence of a prospective control group of an active standard treatment. This paper deals with the design problem of Phase II selection trials in which several experimental regimens are compared to an active control, with an objective to identify an experimental arm that is more effective than the control or to declare futility if no such treatment exists. Conducting a multi-arm randomized selection trial is a useful strategy to prioritize experimental treatments for further testing when many candidates are available, but the sample size required in such a trial with an active control could raise feasibility concerns. In this study, we extend the sequential probability ratio test for normal observations to the multi-arm selection setting. The proposed methods, allowing frequent interim monitoring, offer high likelihood of early trial termination, and as such enhance enrollment feasibility. The termination and selection criteria have closed form solutions and are easy to compute with respect to any given set of error constraints. The proposed methods are applied to design a selection trial in which combinations of sorafenib and erlotinib are compared to a control group in patients with non-small-cell lung cancer using a continuous endpoint of change in tumor size. The operating characteristics of the proposed methods are compared to that of a single-stage design via simulations: The sample size requirement is reduced substantially and is feasible at an early stage of drug development.

  17. Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial.

    PubMed

    Ramamoorthi, Surendar; Nivedhitha, Malli Sureshbabu; Divyanand, Madras Jeyaprakash

    2015-08-01

    The purpose of this study was to evaluate and compare the postoperative level of pain after activation of irrigants using EndoActivator with conventional needle irrigation during root canal therapy. In this prospective randomised clinical trial, 72 symptomatic irreversible pulpitis patients were selected. Based on block randomisation after routine root canal preparation, patients were assigned to two groups. In group EN, procedures were performed with endodontic irrigating needle (n = 36) while group EA received activation using EndoActivator (n = 36) in the final irrigation protocol. All the participants were called through phone at 8, 24 and 48 h to analyse pain score using visual analogue scale. Those patients who developed pain were prescribed ibuprofen 200 mg. Pain score and frequency of tablet intake were recorded and statistically analysed. Results showed that group EA resulted in significantly less postoperative pain and analgesics intake than group EN. In conclusion, within the limitations of this study, the activation of irrigants using EndoActivator can be considered an effective method for reducing postoperative pain. © 2014 Australian Society of Endodontology.

  18. Physical Activity Self-Management and Coaching Compared to Social Interaction in Huntington Disease: Results From the ENGAGE-HD Randomized, Controlled Pilot Feasibility Trial

    PubMed Central

    Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; Rosser, Anne; Hood, Kerenza

    2017-01-01

    Abstract Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention compared with social contact in Huntington disease (HD) to inform the design of a future full-scale trial. Design. Assessor blind, multisite, randomized pilot feasibility trial. Setting. Participants were recruited and assessed at baseline, 16 weeks following randomization, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention. People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements. Eligibility, recruitment, retention, and intervention participation were determined at 16 weeks. Other outcomes of interest included measures of mobility, self-efficacy, physical activity, and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results. Forty percent (n = 46) of eligible patients were enrolled; 22 were randomized to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92%, respectively. Minimum participation criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between-group treatment effects on function; however, increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lend support to our predefined intervention logic model. Limitations. The use of self-report measures may have introduced bias. Conclusions. An HD physical activity self-management and coaching intervention is feasible and worthy of further

  19. Explaining physical activity levels from a self-efficacy perspective: the physical activity counseling trial.

    PubMed

    Blanchard, Chris M; Fortier, Michelle; Sweet, Shane; O'Sullivan, Tracey; Hogg, William; Reid, Robert D; Sigal, Ronald J

    2007-01-01

    The Physical Activity Counseling (PAC) trial compared the effects of a 13-week primary care physical activity (PA) intervention that incorporated a PA counselor into a health care practice compared to a control condition on PA over a 25-week period and showed group differences in PA were present at 6 and 13 weeks. The main purpose was to examine the mediating effect of 6-week task and barrier self-efficacy on the intervention versus control group/13-week PA relationships. A secondary purpose was to determine whether task and barrier self-efficacy were significantly related to PA throughout the trial for both groups. Participants were primarily sedentary individuals who received a 2- to 4-min PA intervention from their primary care provider, after which they were randomly assigned to the intervention (n = 61) or control condition (n = 59). Self-reported PA and task (barrier) self-efficacy measures were obtained during (i.e., baseline, 6 and 13 weeks) and after (i.e., 19 and 25 weeks) the intervention in both groups. Six-week task and barrier self-efficacy had a small mediating effect. Furthermore, barrier self-efficacy had a significant relationship with PA throughout the trial, whereas the relationship between task self-efficacy and PA became significantly weaker as the trial progressed. PAC interventions among primarily sedentary individuals should be partly based on barrier and task self-efficacy. However, the stability of the task self-efficacy/PA relationship needs further examination.

  20. Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial.

    PubMed

    Dedering, Åsa; Halvorsen, Marie; Cleland, Joshua; Svensson, Mikael; Peolsson, Anneli

    2014-08-12

    Patients with cervical radiculopathy often have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods. The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity. The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity. A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions. The interventions will be delivered by experienced physiotherapists and last 14 weeks. The primary outcome variable is neck- and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3, 6, 12 and 24 months after base-line assessment. We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy. ClinicalTrials.gov identifier: NCT01831271.

  1. Family planning to promote physical activity: a randomized controlled trial protocol.

    PubMed

    Quinlan, Alison; Rhodes, Ryan E; Blanchard, Chris M; Naylor, Patti-Jean; Warburton, Darren E R

    2015-10-05

    Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines. A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families. This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families. This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the

  2. PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms

    PubMed Central

    Shrier, AA; Antonijevic, Z; Beckman, RA; Campbell, RK; Chen, C; Flaherty, KT; Loewy, J; Lacombe, D; Madhavan, S; Selker, HP; Esserman, LJ

    2016-01-01

    Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real‐world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints—aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange. PMID:27643536

  3. Average is optimal: an inverted-U relationship between trial-to-trial brain activity and behavioral performance.

    PubMed

    He, Biyu J; Zempel, John M

    2013-01-01

    It is well known that even under identical task conditions, there is a tremendous amount of trial-to-trial variability in both brain activity and behavioral output. Thus far the vast majority of event-related potential (ERP) studies investigating the relationship between trial-to-trial fluctuations in brain activity and behavioral performance have only tested a monotonic relationship between them. However, it was recently found that across-trial variability can correlate with behavioral performance independent of trial-averaged activity. This finding predicts a U- or inverted-U- shaped relationship between trial-to-trial brain activity and behavioral output, depending on whether larger brain variability is associated with better or worse behavior, respectively. Using a visual stimulus detection task, we provide evidence from human electrocorticography (ECoG) for an inverted-U brain-behavior relationship: When the raw fluctuation in broadband ECoG activity is closer to the across-trial mean, hit rate is higher and reaction times faster. Importantly, we show that this relationship is present not only in the post-stimulus task-evoked brain activity, but also in the pre-stimulus spontaneous brain activity, suggesting anticipatory brain dynamics. Our findings are consistent with the presence of stochastic noise in the brain. They further support attractor network theories, which postulate that the brain settles into a more confined state space under task performance, and proximity to the targeted trajectory is associated with better performance.

  4. Comparative efficacy of golimumab, infliximab, and adalimumab for moderately to severely active ulcerative colitis: a network meta-analysis accounting for differences in trial designs.

    PubMed

    Thorlund, Kristian; Druyts, Eric; Toor, Kabirraaj; Mills, Edward J

    2015-05-01

    To conduct a network meta-analysis (NMA) to establish the comparative efficacy of infliximab, adalimumab and golimumab for the treatment of moderately to severely active ulcerative colitis (UC). A systematic literature search identified five randomized controlled trials for inclusion in the NMA. One trial assessed golimumab, two assessed infliximab and two assessed adalimumab. Outcomes included clinical response, clinical remission, mucosal healing, sustained clinical response and sustained clinical remission. Innovative methods were used to allow inclusion of the golimumab trial data given the alternative design of this trial (i.e., two-stage re-randomization). After induction, no statistically significant differences were found between golimumab and adalimumab or between golimumab and infliximab. Infliximab was statistically superior to adalimumab after induction for all outcomes and treatment ranking suggested infliximab as the superior treatment for induction. Golimumab and infliximab were associated with similar efficacy for achieving maintained clinical remission and sustained clinical remission, whereas adalimumab was not significantly better than placebo for sustained clinical remission. Golimumab and infliximab were also associated with similar efficacy for achieving maintained clinical response, sustained clinical response and mucosal healing. Finally, golimumab 50 and 100 mg was statistically superior to adalimumab for clinical response and sustained clinical response, and golimumab 100 mg was also statistically superior to adalimumab for mucosal healing. The results of our NMA suggest that infliximab was statistically superior to adalimumab after induction, and that golimumab was statistically superior to adalimumab for sustained outcomes. Golimumab and infliximab appeared comparable in efficacy.

  5. Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial.

    PubMed

    van Herwaarden, Noortje; van der Maas, Aatke; Minten, Michiel J M; van den Hoogen, Frank H J; Kievit, Wietske; van Vollenhoven, Ronald F; Bijlsma, Johannes W J; van den Bemt, Bart J F; den Broeder, Alfons A

    2015-04-09

    To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor (TNF) inhibitors, adalimumab or etanercept, is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care. Randomised controlled, open label, non-inferiority strategy trial. Two rheumatology outpatient clinics in the Netherlands, from December 2011 to May 2014. 180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept; 121 allocated to the dose reduction strategy, 59 to usual care. Disease activity guided dose reduction (advice to stepwise increase the injection interval every three months, until flare of disease activity or discontinuation) or usual care (no dose reduction advice). Flare was defined as increase in DAS28-CRP (a composite score measuring disease activity) greater than 1.2, or increase greater than 0.6 and current score of at least 3.2. In the case of flare, TNF inhibitor use was restarted or escalated. Difference in proportions of patients with major flare (DAS28-CRP based flare longer than three months) between the two groups at 18 months, compared against a non-inferiority margin of 20%. Secondary outcomes included TNF inhibitor use at study end, functioning, quality of life, radiographic progression, and adverse events. Dose reduction of adalimumab or etanercept was non-inferior to usual care (proportion of patients with major flare at 18 months, 12% v 10%; difference 2%, 95% confidence interval -12% to 12%). In the dose reduction group, TNF inhibitor use could successfully be stopped in 20% (95% confidence interval 13% to 28%), the injection interval successfully increased in 43% (34% to 53%), but no dose reduction was possible in 37% (28% to 46%). Functional status, quality of life, relevant radiographic progression, and adverse events did not differ between the groups, although short lived flares (73% v 27%) and minimal radiographic progression (32% v 15

  6. Activity Monitor Intervention to Promote Physical Activity of Physicians-In-Training: Randomized Controlled Trial

    PubMed Central

    Thorndike, Anne N.; Mills, Sarah; Sonnenberg, Lillian; Palakshappa, Deepak; Gao, Tian; Pau, Cindy T.; Regan, Susan

    2014-01-01

    Background Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. Methods We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention) or to a blinded monitor (control). Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1) median steps/day and 2) proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day). Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. Results In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16) and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73). In Phase 2 (team competition), residents recorded more steps/day than during Phase 1 (Control: 7,971 vs. 7,567, p = 0.002; Intervention: 7,832 vs. 7,739, p = 0.13). Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001). Mean systolic blood pressure decreased (p = 0.004) and HDL cholesterol increased (p<0.001) among all participants at end of study compared to baseline. Conclusions Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more intensive

  7. Testing a workplace physical activity intervention: a cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

  8. New treatments compared to established treatments in randomized trials

    PubMed Central

    Djulbegovic, Benjamin; Kumar, Ambuj; Glasziou, Paul P; Perera, Rafael; Reljic, Tea; Dent, Louise; Raftery, James; Johansen, Marit; Di Tanna, Gian Luca; Miladinovic, Branko; Soares, Heloisa P; Vist, Gunn E; Chalmers, Iain

    2012-01-01

    Background The proportion of proposed new treatments that are ’successful’ is of ethical, scientific, and public importance. We investigated how often new, experimental treatments evaluated in randomized controlled trials (RCTs) are superior to established treatments. Objectives Our main question was: “On average how often are new treatments more effective, equally effective or less effective than established treatments?” Additionally, we wanted to explain the observed results, i.e. whether the observed distribution of outcomes is consistent with the ’uncertainty requirement’ for enrollment in RCTs. We also investigated the effect of choice of comparator (active versus no treatment/placebo) on the observed results. Search methods We searched the Cochrane Methodology Register (CMR) 2010, Issue 1 in The Cochrane Library (searched 31 March 2010); MEDLINE Ovid 1950 to March Week 2 2010 (searched 24 March 2010); and EMBASE Ovid 1980 to 2010 Week 11 (searched 24 March 2010). Selection criteria Cohorts of studies were eligible for the analysis if they met all of the following criteria: (i) consecutive series of RCTs, (ii) registered at or before study onset, and (iii) compared new against established treatments in humans. Data collection and analysis RCTs from four cohorts of RCTs met all inclusion criteria and provided data from 743 RCTs involving 297,744 patients. All four cohorts consisted of publicly funded trials. Two cohorts involved evaluations of new treatments in cancer, one in neurological disorders, and one for mixed types of diseases. We employed kernel density estimation, meta-analysis and meta-regression to assess the probability of new treatments being superior to established treatments in their effect on primary outcomes and overall survival. Main results The distribution of effects seen was generally symmetrical in the size of difference between new versus established treatments. Meta-analytic pooling indicated that, on average, new treatments

  9. Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials.

    PubMed

    Mount, David L; Feeney, Patricia; Fabricatore, Anthony N; Coday, Mace; Bahnson, Judy; Byington, Robert; Phelan, Suzanne; Wilmoth, Sharon; Knowler, William C; Hramiak, Irene; Osei, Kwame; Sweeney, Mary Ellen; Espeland, Mark A

    2009-10-01

    Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons. As a case study, to examine the overlap of study cohorts in two large randomized controlled clinical trials that assess interventions to reduce risk of major cardiovascular disease events in adults with type 2 diabetes in order to explore the feasibility of cross-trial comparisons The Action for Health in Diabetes (Look AHEAD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trials enrolled 5145 and 10,251 adults with type 2 diabetes, respectively. Look AHEAD assesses the efficacy of an intensive lifestyle intervention designed to produce weight loss; ACCORD tests pharmacological therapies for control of glycemia, hyperlipidemia, and hypertension. Incidence of major cardiovascular disease events is the primary outcome for both trials. A sample was constructed to include participants from each trial who appeared to meet eligibility criteria and be appropriate candidates for the other trial's interventions. Demographic characteristics, health status, and outcomes of members and nonmembers of this constructed sample were compared. Nearly 80% of Look AHEAD participants were projected to be ineligible for ACCORD; ineligibility was primarily due to better glycemic control or no early history of cardiovascular disease. Approximately 30% of ACCORD participants were projected to be ineligible for Look AHEAD, often for reasons linked to poorer health. The characteristics of participants projected to be jointly eligible for both trials continued to reflect differences between trials according to factors likely linked to retention, adherence, and study outcomes. Accurate ascertainment of cross-trial eligibility was hampered by differences between protocols. Despite several similarities, the Look AHEAD and ACCORD cohorts represent distinct populations. Even within the subsets of participants who appear to

  10. Comparative effectiveness of glycemic control in patients with type 2 diabetes treated with GLP-1 receptor agonists: a network meta-analysis of placebo-controlled and active-comparator trials

    PubMed Central

    Orme, Michelle E; Nguyen, Hiep; Lu, Jackie Y; Thomas, Susan A

    2017-01-01

    Background Clinical studies of patients with type 2 diabetes show that GLP-1 receptor agonists (GLP-1 RAs) improve glycemic control and promote weight loss. We conducted a Bayesian network meta-analysis (NMA) of placebo- and active-controlled randomized trials to assess the comparative effectiveness of liraglutide, albiglutide, dulaglutide, and exenatide twice daily and once weekly, with a focus on glycemic control. Materials and methods We searched Medline, Embase, and the Cochrane Library (up to December 2014) for core registration programs for US-approved GLP-1 RAs. Patients reaching an A1C target of <7% were analyzed with a binomial model and change in A1C from baseline with a normal model. A covariate analysis assessed the impact of baseline A1C and treatment background on outcomes. Results The base-case NMA used 23 trials reporting A1C outcomes at ~6 month follow-up. The results, unadjusted and adjusted for baseline A1C, indicated that all GLP-1 RAs resulted in statistically significantly lower A1C at follow-up compared with placebo. The odds of reaching the <7% target were also significantly better compared with placebo. With dulaglutide, exenatide once weekly, and liraglutide, the absolute reduction in A1C at 6 months was 0.9%–1.4%, and was significantly better than exenatide twice daily. Albiglutide was not significantly different from exenatide twice daily. We estimate that ~50% of patients will meet the <7% A1C target within 6 months of commencing GLP-1 RAs. Conclusion This was a comprehensive assessment of the comparative effectiveness of GLP-1 RAs and A1C outcome. GLP-1 RAs are a viable addition to oral antidiabetes therapy, and dulaglutide, exenatide once weekly, and liraglutide are the most effective. PMID:28435304

  11. Activating clinical trials: a process improvement approach.

    PubMed

    Martinez, Diego A; Tsalatsanis, Athanasios; Yalcin, Ali; Zayas-Castro, José L; Djulbegovic, Benjamin

    2016-02-24

    The administrative process associated with clinical trial activation has been criticized as costly, complex, and time-consuming. Prior research has concentrated on identifying administrative barriers and proposing various solutions to reduce activation time, and consequently associated costs. Here, we expand on previous research by incorporating social network analysis and discrete-event simulation to support process improvement decision-making. We searched for all operational data associated with the administrative process of activating industry-sponsored clinical trials at the Office of Clinical Research of the University of South Florida in Tampa, Florida. We limited the search to those trials initiated and activated between July 2011 and June 2012. We described the process using value stream mapping, studied the interactions of the various process participants using social network analysis, and modeled potential process modifications using discrete-event simulation. The administrative process comprised 5 sub-processes, 30 activities, 11 decision points, 5 loops, and 8 participants. The mean activation time was 76.6 days. Rate-limiting sub-processes were those of contract and budget development. Key participants during contract and budget development were the Office of Clinical Research, sponsors, and the principal investigator. Simulation results indicate that slight increments on the number of trials, arriving to the Office of Clinical Research, would increase activation time by 11 %. Also, incrementing the efficiency of contract and budget development would reduce the activation time by 28 %. Finally, better synchronization between contract and budget development would reduce time spent on batching documentation; however, no improvements would be attained in total activation time. The presented process improvement analytic framework not only identifies administrative barriers, but also helps to devise and evaluate potential improvement scenarios. The strength

  12. Metrics Survey of Industry-Sponsored Clinical Trials in Canada and Comparator Jurisdictions between 2005 and 2010

    PubMed Central

    Leclerc, Jean-Marie; Laberge, Normand; Marion, Jean

    2012-01-01

    Industry-sponsored clinical trials play a key role in the development of therapies. This survey suggests that between 2005 and 2010, research-based pharmaceutical firms worldwide initiated fewer trials and recruited fewer subjects annually. In contrast, at the country level, the clinical trial activity of such firms increased in emerging countries and in Japan. Canada's trend in the number of new trials followed that of the global industry, but the trend in new sites and newly recruited subjects fell below the global rate. Informal comparisons point to potential issues for Canada in such areas as site capacity, cost per subject and time to first subject-in. When compared to certain Western European countries and the United States, Canada remained well positioned on a number of metrics. Nonetheless, Canada faces mounting challenges from both traditional locations and emerging countries and may require coordinated efforts to remain a place of choice to conduct trials. PMID:23968618

  13. Substantia nigra activity level predicts trial-to-trial adjustments in cognitive control

    PubMed Central

    Boehler, C.N.; Bunzeck, N.; Krebs, R.M.; Noesselt, T.; Schoenfeld, M.A.; Heinze, H.-J.; Münte, T.F.; Woldorff, M.G.; Hopf, J.-M.

    2011-01-01

    Effective adaptation to the demands of a changing environment requires flexible cognitive control. The medial and lateral frontal cortices are involved in such control processes, putatively in close interplay with the basal ganglia. In particular, dopaminergic projections from the midbrain (i.e., from the substantia nigra (SN) and the ventral tegmental area (VTA)) have been proposed to play a pivotal role in modulating the activity in these areas for cognitive control purposes. In that dopaminergic involvement has been strongly implicated in reinforcement learning, these ideas suggest functional links between reinforcement learning, where the outcome of actions shapes behavior over time, and cognitive control in a more general context, where no direct reward is involved. Here, we provide evidence from functional MRI in humans that activity in the SN predicts systematic subsequent trial-to-trial response time (RT) prolongations that are thought to reflect cognitive control in a Stop-signal paradigm. In particular, variations in the activity level of the SN in one trial predicted the degree of RT prolongation on the subsequent trial, consistent with a modulating output signal from the SN being involved in enhancing cognitive control. This link between SN activity and subsequent behavioral adjustments lends support to theoretical accounts that propose dopaminergic control signals that shape behavior both in the presence and absence of direct reward. This SN-based modulatory mechanism is presumably mediated via a wider network that determines response speed in this task, including frontal and parietal control regions, along with the basal ganglia and the associated subthalamic nucleus. PMID:20465358

  14. Comparing Two Web-Based Smoking Cessation Programs: Randomized Controlled Trial

    PubMed Central

    McKay, H Garth; Seeley, John R; Lichtenstein, Edward; Gau, Jeff M

    2008-01-01

    Background Smoking cessation remains a significant public health problem. Innovative interventions that use the Internet have begun to emerge that offer great promise in reaching large numbers of participants and encouraging widespread behavior change. To date, the relatively few controlled trials of Web-based smoking cessation programs have been limited by short follow-up intervals. Objective We describe the 6-month follow-up results of a randomized controlled trial in which participants recruited online were randomly assigned to either a Web-based smoking cessation program (Quit Smoking Network; QSN) or a Web-based exercise enhancement program (Active Lives) adapted somewhat to encourage smoking cessation. Methods The study was a two-arm randomized controlled trial that compared two Web-based smoking cessation programs: (1) the QSN intervention condition presented cognitive-behavioral strategies, and (2) the Active Lives control condition provided participants with guidance in developing a physical activity program to assist them with quitting. The QSN condition provided smoking cessation information and behavior change strategies while the Active Lives condition provided participants with physical activity recommendations and goal setting. The QSN condition was designed to be more engaging (eg, it included multimedia components) and to present much greater content than is typically found in smoking cessation programs. Results Contrary to our hypotheses, no between-condition differences in smoking abstinence were found at 3- and 6-month follow-up assessments. While participants in the QSN intervention condition spent more time than controls visiting the online program, the median number of 1.0 visit in each condition and the substantial attrition (60.8% at the 6-month follow-up) indicate that participants were not as engaged as we had expected. Conclusions Contrary to our hypothesis, our test of two Web-based smoking cessation conditions, an intervention and an

  15. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    PubMed Central

    Law, Mary; Darrah, Johanna; Pollock, Nancy; Rosenbaum, Peter; Russell, Dianne; Walter, Stephen D; Petrenchik, Theresa; Wilson, Brenda; Wright, Virginia

    2007-01-01

    Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care

  16. Increasing girls’ physical activity during an organised youth sport basketball program: a randomised controlled trial protocol

    PubMed Central

    2014-01-01

    Background Participation in organised youth sports (OYS) has been recommended as an opportunity to increase young peoples’ moderate-to-vigorous physical activity (MVPA) levels. Participants, however, spend a considerable proportion of time during OYS inactive. The purpose of this study, therefore, was to investigate whether coaches who attended coach education sessions (where education on increasing MVPA and decreasing inactivity during training was delivered) can increase players’ MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions. Methods/design A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney, Australia. A two-arm, parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions (compared with a no-treatment control) can increase their players’ MVPA during training sessions over a 5-day basketball program. Objectively measured physical activity, directly observed lesson context and leader behaviour, player motivation, players’ perceived autonomy support, and coaching information (regarding training session planning, estimations on player physical activity and lesson context during training, perceived ability to modify training sessions, perceived importance of physical activity during training, intention to increase physical activity/reduce inactivity, and likelihood of increasing physical activity/reducing inactivity) were assessed at baseline (day 1) and at follow-up (day 5). Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes. Discussion The current trial protocol describes, to our knowledge, the first trial conducted in an OYS context to investigate the efficacy of an intervention, relative to a control, in increasing MVPA. This study’s findings will

  17. A Randomized Controlled Pilot Trial of Classroom-Based Mindfulness Meditation Compared to an Active Control Condition in 6th Grade Children

    PubMed Central

    Britton, Willoughby B.; Lepp, Nathaniel E.; Niles, Halsey F.; Rocha, Tomas; Fisher, Nathan; Gold, Jonathan

    2014-01-01

    Children in the United States are at risk for numerous psychological problems, such as anxiety, attention problems, and mood disorders, and are underserved by current mental health provisions. The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys and 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported data was collected by administering the Youth Self Report (YSR), a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure -Revised before and after 6 weeks of meditation or active control condition. Both meditators and active controls decreased significantly on the YSR Internalizing Problems, Externalizing Problems, and Attention Problems subscales but did not differ in the extent of their improvements. Both groups also showed comparable improvements on measures in affect. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. Improvements in affect were correlated with increases in mindfulness in meditators but not controls. These results suggest that mindfulness training may yield both unique and nonspecific benefits that are shared by other novel activities. PMID:24930819

  18. Wearable activity monitors in oncology trials: Current use of an emerging technology.

    PubMed

    Gresham, Gillian; Schrack, Jennifer; Gresham, Louise M; Shinde, Arvind M; Hendifar, Andrew E; Tuli, Richard; Rimel, B J; Figlin, Robert; Meinert, Curtis L; Piantadosi, Steven

    2018-01-01

    Physical activity is an important outcome in oncology trials. Physical activity is commonly assessed using self-reported questionnaires, which are limited by recall and response biases. Recent advancements in wearable technology have provided oncologists with new opportunities to obtain real-time, objective physical activity data. The purpose of this review was to describe current uses of wearable activity monitors in oncology trials. We searched Pubmed, Embase, and the Cochrane Central Register of Controlled Trials for oncology trials involving wearable activity monitors published between 2005 and 2016. We extracted details on study design, types of activity monitors used, and purpose for their use. We summarized activity monitor metrics including step counts, sleep and sedentary time, and time spent in moderate-to-vigorous activity. We identified 41 trials of which 26 (63%) involved cancer survivors (post-treatment) and 15 trials (37%) involved patients with active cancer. Most trials (65%) involved breast cancer patients. Wearable activity monitors were commonly used in exercise (54%) or behavioral (29%) trials. Cancer survivors take between 4660 and 11,000 steps/day and those undergoing treatment take 2885 to 8300steps/day. Wearable activity monitors are increasingly being used to obtain objective measures of physical activity in oncology trials. There is potential for their use to expand to evaluate and predict clinical outcomes such as survival, quality of life, and treatment tolerance in future studies. Currently, there remains a lack of standardization in the types of monitors being used and how their data are being collected, analyzed, and interpreted. Recent advancements in wearable activity monitor technology have provided oncologists with new opportunities to monitor their patients' daily activity in real-world settings. The integration of wearable activity monitors into cancer care will help increase our understanding of the associations between

  19. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme.

    PubMed

    Niswender, K; Pi-Sunyer, X; Buse, J; Jensen, K H; Toft, A D; Russell-Jones, D; Zinman, B

    2013-01-01

    We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus (T2DM) treated with liraglutide versus comparator diabetes therapies. Twenty-six-week data from seven phase 3, randomized trials in the liraglutide T2DM development programme were analysed by trial and treatment group: liraglutide (1.2 and 1.8 mg), active comparator and placebo. Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline; impact of body mass index (BMI) and gastrointestinal (GI) adverse events (AEs) on weight change and correlation of weight change with change in glycosylated haemoglobin (HbA1c). A number of subjects experienced >5% weight loss during the trials (24.4% liraglutide 1.8 mg and 17.7% liraglutide 1.2 mg; 17.7% exenatide, 10.0% sitagliptin, 3.6-7.0% sulphonylurea, 2.6% thiazolidinedione and 2.6% glargine; 9.9% placebo). More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide. Across trials, higher initial BMI was associated with slightly greater weight loss with liraglutide. Mean weight loss increased slightly the longer GI AEs persisted. Although HbA1c reduction was slightly larger in higher weight loss categories across treatments (including placebo), sample sizes were small and no clear correlation could be determined. Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced; thus, not all HbA1c-lowering effect appears weight mediated. The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis. Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects. © 2012 Blackwell Publishing Ltd.

  20. The decision to conduct a head-to-head comparative trial: a game-theoretic analysis.

    PubMed

    Mansley, Edward C; Elbasha, Elamin H; Teutsch, Steven M; Berger, Marc L

    2007-01-01

    Recent Medicare legislation calls on the Agency for Healthcare Research and Quality to conduct research related to the comparative effectiveness of health care items and services, including prescription drugs. This reinforces earlier calls for head-to-head comparative trials of clinically relevant treatment alternatives. Using a game-theoretic model, the authors explore the decision of pharmaceutical companies to conduct such trials. The model suggests that an important factor affecting this decision is the potential loss in market share and profits following a result of inferiority or comparability. This hidden cost is higher for the market leader than the market follower, making it less likely that the leader will choose to conduct a trial. The model also suggests that in a full-information environment, it will never be the case that both firms choose to conduct such a trial. Furthermore, if market shares and the probability of proving superiority are similar for both firms, it is quite possible that neither firm will choose to conduct a trial. Finally, the results indicate that incentives that offset the direct cost of a trial can prevent a no-trial equilibrium, even when both firms face the possibility of an inferior outcome.

  1. Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

    PubMed

    Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2015-01-01

    Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P < .05). No significant difference was found between the study groups regarding hair count either at month 3 or month 6 (> .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P < .05). Scalp itching, however, was more frequent in the minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

  2. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    PubMed

    Edwards, Meghan K; Loprinzi, Paul D

    2018-03-01

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  3. The role of private industry in pragmatic comparative effectiveness trials.

    PubMed

    Buesching, Don P; Luce, Bryan R; Berger, Marc L

    2012-03-01

    Comparative effectiveness research (CER) includes pragmatic clinical trials (PCTs) to address 'real-world' effectiveness. CER interest would be expected to stimulate biopharmaceutical manufacturer PCT investment; however, this does not seem to be the case. In this article we identify all industry-sponsored PCT studies from 1996 to 2010; analyze them across a variety of characteristics, including sponsor, research question, design, comparators and results; and suggest methodological and policy changes to spur future manufacturer PCT investment. Nine 'naturalistic', head-to-head versus standard of care or similar agent PCTs were identified. Two included a 'usual care' arm. Chronic care trials' length averaged 12 months (range: 6-24 months), six of which reported equivocal or no difference in effectiveness; results of two chronic and the single acute care PCTs favored the sponsor drug. None reported the sponsor drug inferior. Of seven that evaluated utilization or costs, six reported no differences and four of five studies comparing brand-generic drugs reported no difference. Whereas private investment in PCTs is in the public interest, manufacturers apparently have not yet seen the business case. To induce investment, we propose several methodological and regulatory policy innovations designed to reduce business risk by decreasing outcome variability and increasing trial efficiency, flexibility and market applicability.

  4. Promoting Activity in Geriatric Rehabilitation: A Randomized Controlled Trial of Accelerometry.

    PubMed

    Peel, Nancye M; Paul, Sanjoy K; Cameron, Ian D; Crotty, Maria; Kurrle, Susan E; Gray, Leonard C

    2016-01-01

    Low activity levels in inpatient rehabilitation are associated with adverse outcomes. The study aimed to test whether activity levels can be increased by the provision of monitored activity data to patients and clinicians in the context of explicit goal setting. A randomized controlled trial in three sites in Australia included 255 inpatients aged 60 and older who had a rehabilitation goal to become ambulant. The primary outcome was patients' walking time measured by accelerometers during the rehabilitation admission. Walking times from accelerometry were made available daily to treating therapists and intervention participants to motivate patients to improve incidental activity levels and reach set goals. For the control group, 'usual care' was followed, including the setting of mobility goals; however, for this group, neither staff nor patients received data on walking times to aid the setting of daily walking time targets. The median daily walking time in the intervention group increased from 10.3 minutes at baseline to 32.1 minutes at day 28, compared with an increase from 9.5 to 26.5 minutes per day in the control group. Subjects in the intervention group had significantly higher non-therapy walking time by about 7 minutes [mean (95% CI): 24.6 (21.7, 27.4)] compared to those in the control group [mean(95% CI): 17.3 (14.4, 20.3)] (p = 0.001). Daily feedback to patients and therapists using an accelerometer increased walking times during rehabilitation admissions. The results of this study suggest objective monitoring of activity levels could provide clinicians with information on clinically important, mobility-related activities to assist goal setting. Australian New Zealand Clinical Trials Registry ACTRN12611000034932 http://www.ANZCTR.org.au/.

  5. Active-comparator design and new-user design in observational studies

    PubMed Central

    Yoshida, Kazuki; Solomon, Daniel H.; Kim, Seoyoung C.

    2015-01-01

    SUMMARY Over the past decade, an increasing number of observational studies have examined the effectiveness or safety of rheumatoid arthritis treatments. However, unlike randomized controlled trials (RCTs), observational studies of drug effects face methodological challenges including confounding by indication. Two design principles - active comparator design and new user design can help mitigate such challenges in observational studies. To improve validity of study findings, observational studies should be designed in such a way that makes them more closely approximate RCTs. The active comparator design compares the drug of interest to another commonly used agent for the same indication, rather than a ‘non-user’ group. This principle helps select treatment groups similar in treatment indications (both measured and unmeasured characteristics). The new user design includes a cohort of patients from the time of treatment initiation, so that it can assess patients’ pretreatment characteristics and capture all events occurring anytime during follow-up. PMID:25800216

  6. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial.

    PubMed

    Thomson, Jessica L; Tussing-Humphreys, Lisa M; Goodman, Melissa H; Olender, Sarah E

    2016-01-01

    Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n = 82), enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

  7. Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

    PubMed

    King, Abby C; Campero, Ines; Sheats, Jylana L; Castro Sweet, Cynthia M; Garcia, Dulce; Chazaro, Aldo; Blanco, German; Hauser, Michelle; Fierros, Fernando; Ahn, David K; Diaz, Jose; Done, Monica; Fernandez, Juan; Bickmore, Timothy

    2017-10-01

    While physical inactivity is a key risk factor for a range of chronic diseases and conditions associated with aging, a significant proportion of midlife and older adults remain insufficiently active. This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. The major objective of this 12-month cluster-randomized controlled trial is to test the comparative effectiveness of two linguistically and culturally adapted, community-based physical activity interventions with the potential for broad reach and translation. Ten local community centers serving a sizable number of Latino residents were randomized to receive one of two physical activity interventions. The Virtual Advisor program employs a computer-based embodied conversational agent named "Carmen" to deliver interactive, individually tailored physical activity advice and support. A similar intervention program is delivered by trained Peer Advisors. The target population consists of generally healthy, insufficiently active Latino adults ages 50years and older living within proximity to a designated community center. The major outcomes are changes in walking and other forms of physical activity measured via self-report and accelerometry. Secondary outcomes include physical function and well-being variables. In addition to these outcome analyses, comparative cost analysis of the two programs, potential mediators of intervention success, and baseline moderators of intervention effects will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yield as well as study baseline characteristics. clinicaltrial.gov Identifier=NCT02111213. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Physical activity for smoking cessation in pregnancy: randomised controlled trial.

    PubMed

    Ussher, Michael; Lewis, Sarah; Aveyard, Paul; Manyonda, Isaac; West, Robert; Lewis, Beth; Marcus, Bess; Riaz, Muhammad; Taylor, Adrian; Daley, Amanda; Coleman, Tim

    2015-05-14

    To determine the effectiveness of a physical activity intervention for smoking cessation during pregnancy. Parallel group, randomised controlled, multicentre trial. 13 hospitals in England, April 2009 to January 2014. 789 pregnant smokers, aged 16-50 years and at 10-24 weeks' gestation, who smoked at least one cigarette daily and were prepared to quit smoking one week after enrollment were randomised (1:1); 785 were included in the intention to treat analyses, with 392 assigned to the physical activity group. Interventions began one week before a target quit date. Participants were randomised to six weekly sessions of behavioural support for smoking cessation (control) or to this support plus 14 sessions combining supervised treadmill exercise and physical activity consultations. The primary outcome was continuous smoking abstinence from the target quit date until end of pregnancy, validated by exhaled carbon monoxide or salivary cotinine levels. To assess adherence, levels of moderate-vigorous intensity physical activity were self reported and in a 11.5% (n=90) random subsample of participants, physical activity was objectively measured by an accelerometer. No significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups (8% v 6%; odds ratio 1.21, 95% confidence interval 0.70 to 2.10). For the physical activity group compared with the control group, there was a 40% (95% confidence interval 13% to 73%), 34% (6% to 69%), and 46% (12% to 91%) greater increase in self reported minutes carrying out physical activity per week from baseline to one week, four weeks, and six weeks post-quit day, respectively. According to the accelerometer data there was no significant difference in physical activity levels between the groups. Participants attended a median of four treatment sessions in the intervention group and three in the control group. Adverse events and birth outcomes were similar between the two

  9. Health Activities Project (HAP), Trial Edition III.

    ERIC Educational Resources Information Center

    Buller, Dave; And Others

    Contained within this Health Activities Project (HAP) trial edition (set III) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into an Overview, Health Background, Materials, Setting Up, and…

  10. Grand average ERP-image plotting and statistics: A method for comparing variability in event-related single-trial EEG activities across subjects and conditions

    PubMed Central

    Delorme, Arnaud; Miyakoshi, Makoto; Jung, Tzyy-Ping; Makeig, Scott

    2014-01-01

    With the advent of modern computing methods, modeling trial-to-trial variability in biophysical recordings including electroencephalography (EEG) has become of increasingly interest. Yet no widely used method exists for comparing variability in ordered collections of single-trial data epochs across conditions and subjects. We have developed a method based on an ERP-image visualization tool in which potential, spectral power, or some other measure at each time point in a set of event-related single-trial data epochs are represented as color coded horizontal lines that are then stacked to form a 2-D colored image. Moving-window smoothing across trial epochs can make otherwise hidden event-related features in the data more perceptible. Stacking trials in different orders, for example ordered by subject reaction time, by context-related information such as inter-stimulus interval, or some other characteristic of the data (e.g., latency-window mean power or phase of some EEG source) can reveal aspects of the multifold complexities of trial-to-trial EEG data variability. This study demonstrates new methods for computing and visualizing grand ERP-image plots across subjects and for performing robust statistical testing on the resulting images. These methods have been implemented and made freely available in the EEGLAB signal-processing environment that we maintain and distribute. PMID:25447029

  11. Health Activities Project (HAP), Trial Edition II.

    ERIC Educational Resources Information Center

    Buller, Dave; And Others

    Contained within this Health Activities Project (HAP) trial edition (set II) are a teacher information folio and numerous student activity folios which center around the idea that students in grades 5-8 can control their own health and safety. Each student folio is organized into a Synopsis, Health Background, Materials, Setting Up, and Activities…

  12. Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial.

    PubMed

    Kwasnicka, Dominika; Vandelanotte, Corneel; Rebar, Amanda; Gardner, Benjamin; Short, Camille; Duncan, Mitch; Crook, Dawn; Hagger, Martin S

    2017-05-26

    Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Healthcare professionals (N = 192) will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1) education only (non-tailored information only), (2) education plus intervention components to enhance motivation, (3) education plus components to enhance motivation and self-regulation, and (4) education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention effect. This is the first study to examine a tailored

  13. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

    PubMed

    Thorndike, Anne N; Mills, Sarah; Sonnenberg, Lillian; Palakshappa, Deepak; Gao, Tian; Pau, Cindy T; Regan, Susan

    2014-01-01

    Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention) or to a blinded monitor (control). Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1) median steps/day and 2) proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day). Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16) and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73). In Phase 2 (team competition), residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; 7,832 vs. 7,739, p = 0.13). Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001). Mean systolic blood pressure decreased (p = 0.004) and HDL cholesterol increased (p<0.001) among all participants at end of study compared to baseline. Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more intensive hospital-based wellness programs have potential for

  14. Ethical pitfalls in neonatal comparative effectiveness trials.

    PubMed

    Modi, Neena

    2014-01-01

    oxygen that are too low or too high. Investigators in the UK, Australia, New Zealand and the USA designed randomized controlled trials to provide more precise guidance, by determining whether targeting the lower end of the accepted range (85-89%) resulted in reduced retinopathy of prematurity when compared with the upper end of the accepted range (91-95%). Between 2004 and 2009, the US SUPPORT trial (Surfactant, Positive Pressure and Oxygenation Randomized Trial) recruited approximately 1,300 infants and showed that babies at the higher end of the recommended oxygen saturation range had a greater incidence of retinopathy of prematurity, but that, unexpectedly, babies at the lower end had a higher risk of death [1]. The data monitoring committees of the BOOST II (Oxygen Saturation and Outcomes in Preterm Infants) trials in the UK, Australia and New Zealand reviewed their interim data, confirmed the higher risk of death in babies randomized to the lower saturation range, and halted further recruitment [2]. Without the trials, the lower saturation target would have continued to be applied to many babies, and many would have died as a result. Though many uncertainties remain, the trials facilitated advances in care. However, in March 2013, the lead investigators for the SUPPORT trial were informed by the US 'Office for Human Research Protections' that they were 'in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death' [3]. This extraordinary conclusion indicates that the US regulators considered the researchers to be at fault for failing to foresee an unexpected trial result, and for randomizing babies to receive oxygen within the accepted standard-of-care limits. The ruling further implies that the regulators consider that clinicians are acting ethically when they deliver an accepted but non-evidence-based treatment based upon their personal bias, but

  15. Comparing the Effectiveness of Error-Correction Strategies in Discrete Trial Training

    ERIC Educational Resources Information Center

    Turan, Michelle K.; Moroz, Lianne; Croteau, Natalie Paquet

    2012-01-01

    Error-correction strategies are essential considerations for behavior analysts implementing discrete trial training with children with autism. The research literature, however, is still lacking in the number of studies that compare and evaluate error-correction procedures. The purpose of this study was to compare two error-correction strategies:…

  16. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    PubMed

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  17. Invasion of the Zebra Mussels: A Mock Trial Activity

    ERIC Educational Resources Information Center

    Beck, Judy A.; Czerniak, Charlene M.

    2005-01-01

    In this activity, students learn about the important topic of invasive species, specifically Zebra Mussels. Students role-play different characters in a real-life situation: the trial of the Zebra Mussel for unlawful disruption of the Great Lakes ecosystem. Students will also learn about jurisprudential inquiry by examining the trial process. This…

  18. Randomized trials published in Chinese or Western journals: comparative empirical analysis.

    PubMed

    Purgato, Marianna; Cipriani, Andrea; Barbui, Corrado

    2012-06-01

    A major concern to the inclusion in systematic reviews of studies originating in China and published in Chinese journals refers to the quality of study reporting. In this systematic survey of randomized trials, we compared the characteristics of studies published in Chinese journals with those of studies published in Western journals. We included 69 studies comparing citalopram with other antidepressant drugs in the treatment of major depression. Of these, 37 (54%) were published in Chinese journals. The standard of reporting was generally poor in both Western and Chinese studies. In some Chinese studies, the generation of the randomization sequence raised concern about their experimental nature, and in almost all included studies, the concealment of allocation was not properly described. Blinding was seldom adopted in Chinese studies, and the risk of sponsorship bias was uncertain because Chinese studies did not report any financial support. In most Western studies, outcome data were selectively and incompletely reported. Pooling together all trials revealed that citalopram was similarly effective in comparison with all other antidepressant drugs both in Western studies (standardized mean difference, -0.04; 95% confidence interval, -0.15 to 0.06) and in Chinese studies (standardized mean difference, -0.08, 95% confidence interval, -0.18 to 0.02). Randomized controlled trials published in Chinese journals represent most of the studies included in this review. This suggests that omitting to search biomedical databases originating from China would systematically exclude a relevant proportion of randomized trials published in Chinese journals, with a risk of random error or bias. The increasing inclusion of Chinese studies in systematic reviews reinforces the need to check the quality of randomized trials that are meta-analyzed.

  19. Designing Comparative Effectiveness Trials of Surgical Ablation for Atrial Fibrillation: Experience of the Cardiothoracic Surgical Trials Network

    PubMed Central

    Gillinov, A. Marc; Argenziano, Michael; Blackstone, Eugene H.; Iribarne, Alexander; DeRose, Joseph J.; Ailawadi, Gorav; Russo, Mark J.; Ascheim, Deborah D.; Parides, Michael K.; Rodriguez, Evelio; Bouchard, Denis; Taddei-Peters, Wendy C.; Geller, Nancy L.; Acker, Michael A.; Gelijns, Annetine C.

    2013-01-01

    Background Since the introduction of the cut-and-sew Cox-Maze procedure for atrial fibrillation (AF) there has been substantial innovation in techniques for ablation. Use of alternate energy sources for ablation simplified the procedure and has resulted in dramatic increase in the number of AF patients treated by surgical ablation. Despite its increasingly widespread adoption, there is lack of rigorous clinical evidence to establish this as an effective clinical therapy. Methods and Results This paper describes a comparative effectiveness randomized trial, supported by the Cardiothoracic Surgical Trials Network, of surgical ablation with left atrial appendage (LAA) closure versus LAA closure alone in patients with persistent and longstanding persistent AF undergoing mitral valve surgery. Nested within this trial, is a further randomized comparison of 2 different lesions sets: pulmonary vein isolation and full Maze lesion set. This paper addresses trial design challenges, including how to best characterize the target population, operationalize freedom from AF as a primary endpoint, account for the impact of anti-arrhythmic drugs, and measure and analyze secondary endpoints, such as post-operative AF load. Conclusions This paper concludes by discussing how insights that emerge from this trial may affect surgical practice and guide future research in this area. PMID:21616507

  20. Spinal Motion and Muscle Activity during Active Trunk Movements - Comparing Sheep and Humans Adopting Upright and Quadrupedal Postures.

    PubMed

    Valentin, Stephanie; Licka, Theresia F

    2016-01-01

    Sheep are used as models for the human spine, yet comparative in vivo data necessary for validation is limited. The purpose of this study was therefore to compare spinal motion and trunk muscle activity during active trunk movements in sheep and humans. Three-dimensional kinematic data as well as surface electromyography (sEMG) of spinal flexion and extension was compared in twenty-four humans in upright (UR) and 4-point kneeling (KN) postures and in 17 Austrian mountain sheep. Kinematic markers were attached over the sacrum, posterior iliac spines, and spinous and transverse processes of T5, T8, T11, L2 and L5 in humans and over the sacrum, tuber sacrale, T5, T8, T12, L3 and L7 in sheep. The activity of erector spinae (ES), rectus abdominis (RA), obliquus externus (OE), and obliquus internus (OI) were collected. Maximum sEMG (MOE) was identified for each muscle and trial, and reported as a percentage (MOE%) of the overall maximally observed sEMG from all trials. Spinal range of motion was significantly smaller in sheep compared to humans (UR / KN) during flexion (sheep: 6-11°; humans 12-34°) and extension (sheep: 4°; humans: 11-17°). During extension, MOE% of ES was greater in sheep (median: 77.37%) than UR humans (24.89%), and MOE% of OE and OI was greater in sheep (OE 76.20%; OI 67.31%) than KN humans (OE 21.45%; OI 19.34%), while MOE% of RA was lower in sheep (21.71%) than UR humans (82.69%). During flexion, MOE% of RA was greater in sheep (83.09%) than humans (KN 47.42%; UR 41.38%), and MOE% of ES in sheep (45.73%) was greater than KN humans (14.45%), but smaller than UR humans (72.36%). The differences in human and sheep spinal motion and muscle activity suggest that caution is warranted when ovine data are used to infer human spine biomechanics.

  1. Affective responses in mountain hiking—A randomized crossover trial focusing on differences between indoor and outdoor activity

    PubMed Central

    Einwanger, Jürgen; Hartl, Arnulf; Kopp, Martin

    2017-01-01

    Introduction Affective responses during physical activity (PA) are important for engagement in PA programs and for adherence to a physically active lifestyle. Little is known about the affective responses to PA bouts lasting longer than 45 minutes. Therefore, the aims of the present study were to analyse acute effects on affective responses of a three-hour outdoor PA intervention (mountain hiking) compared to a sedentary control situation and to an indoor treadmill condition. Methods Using a randomized crossover design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (approximately three hours each). Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Repeated measures ANOVAs were used to analyse differences between the conditions. Results Compared to the control situation, the participants showed a significant increase in affective valence (d = 1.21, p < .001), activation (d = 0.81, p = .004), elation (d = 1.07, p < .001), and calmness (d = 0.84, p = .004), and a significant decrease in fatigue (d = -1.19, p < .001) and anxiety (d = -.79, p < .001) after mountain hiking. Outdoor mountain hiking showed significantly greater positive effects on affective valence, activation, and fatigue compared to indoor treadmill walking. Discussion The results indicate that a three-hour PA intervention (mountain hiking) elicits higher positive and lower negative affective responses compared to a sedentary control situation and to an indoor PA condition. Outdoor mountain hiking can be recommended by health professionals as a form of PA with the potential to positively influence affective responses. Trial registration ClinicalTrials.gov NCT02853760. https://clinicaltrials.gov/. Date of registration: 08/02/2016 (retrospectively registered). Date of enrolment of the first participant to the trial: 05/01/2014. PMID:28520774

  2. Utility-based designs for randomized comparative trials with categorical outcomes

    PubMed Central

    Murray, Thomas A.; Thall, Peter F.; Yuan, Ying

    2016-01-01

    A general utility-based testing methodology for design and conduct of randomized comparative clinical trials with categorical outcomes is presented. Numerical utilities of all elementary events are elicited to quantify their desirabilities. These numerical values are used to map the categorical outcome probability vector of each treatment to a mean utility, which is used as a one-dimensional criterion for constructing comparative tests. Bayesian tests are presented, including fixed sample and group sequential procedures, assuming Dirichlet-multinomial models for the priors and likelihoods. Guidelines are provided for establishing priors, eliciting utilities, and specifying hypotheses. Efficient posterior computation is discussed, and algorithms are provided for jointly calibrating test cutoffs and sample size to control overall type I error and achieve specified power. Asymptotic approximations for the power curve are used to initialize the algorithms. The methodology is applied to re-design a completed trial that compared two chemotherapy regimens for chronic lymphocytic leukemia, in which an ordinal efficacy outcome was dichotomized and toxicity was ignored to construct the trial’s design. The Bayesian tests also are illustrated by several types of categorical outcomes arising in common clinical settings. Freely available computer software for implementation is provided. PMID:27189672

  3. Effects of Long-Term Acupuncture Treatment on Resting-State Brain Activity in Migraine Patients: A Randomized Controlled Trial on Active Acupoints and Inactive Acupoints

    PubMed Central

    Zhao, Ling; Liu, Jixin; Zhang, Fuwen; Dong, Xilin; Peng, Yulin; Qin, Wei; Wu, Fumei; Li, Ying; Yuan, Kai; von Deneen, Karen M.; Gong, Qiyong; Tang, Zili; Liang, Fanrong

    2014-01-01

    Background Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. Methods and Results A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. Conclusions Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003635 PMID:24915066

  4. Maintained physical activity and physiotherapy in the management of distal upper limb pain – a protocol for a randomised controlled trial (the arm pain trial)

    PubMed Central

    2014-01-01

    Background Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Methods/Design Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Discussion Results from this trial will contribute to

  5. Sample size calculations for comparative clinical trials with over-dispersed Poisson process data.

    PubMed

    Matsui, Shigeyuki

    2005-05-15

    This paper develops a new formula for sample size calculations for comparative clinical trials with Poisson or over-dispersed Poisson process data. The criteria for sample size calculations is developed on the basis of asymptotic approximations for a two-sample non-parametric test to compare the empirical event rate function between treatment groups. This formula can accommodate time heterogeneity, inter-patient heterogeneity in event rate, and also, time-varying treatment effects. An application of the formula to a trial for chronic granulomatous disease is provided. Copyright 2004 John Wiley & Sons, Ltd.

  6. A cluster-randomized controlled trial of strategies to increase adolescents’ physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP) trial

    PubMed Central

    2012-01-01

    Background The physical activity (PA) levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE) programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children’s motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT), on PA levels, and their hypothesized antecedents, during year 8 PE lessons. Methods/design This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16) and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1) explaining the relevance of activities; (2) providing choice from PA options selected by the teacher; (3) providing equipment and free choice of activities; or (4) usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested within teachers as a

  7. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

    PubMed

    Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

    2017-11-09

    Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

  8. Comparing the Score Distribution of a Trial Computer-Based Examination Cohort with That of the Standard Paper-Based Examination Cohort

    ERIC Educational Resources Information Center

    Zoanetti, Nathan; Les, Magdalena; Leigh-Lancaster, David

    2014-01-01

    From 2011-2013 the VCAA conducted a trial aligning the use of computers in curriculum, pedagogy and assessment culminating in a group of 62 volunteer students sitting their end of Year 12 technology-active Mathematical Methods (CAS) Examination 2 as a computer-based examination. This paper reports on statistical modelling undertaken to compare the…

  9. The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application

    PubMed Central

    Lund, Jennifer L.; Richardson, David B.; Stürmer, Til

    2016-01-01

    Better understanding of biases related to selective prescribing of, and adherence to, preventive treatments has led to improvements in the design and analysis of pharmacoepidemiologic studies. One influential development has been the “active comparator, new user” study design, which seeks to emulate the design of a head-to-head randomized controlled trial. In this review, we first discuss biases that may affect pharmacoepidemiologic studies and describe their direction and magnitude in a variety of settings. We then present the historical foundations of the active comparator, new user study design and explain how this design conceptually mitigates biases leading to a paradigm shift in pharmacoepidemiology. We offer practical guidance on the implementation of the study design using administrative databases. Finally, we provide an empirical example in which the active comparator, new user study design addresses biases that have previously impeded pharmacoepidemiologic studies. PMID:26954351

  10. Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

    PubMed

    James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

    2016-08-01

    Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. A pilot randomized, controlled trial of an active video game physical activity intervention.

    PubMed

    Peng, Wei; Pfeiffer, Karin A; Winn, Brian; Lin, Jih-Hsuan; Suton, Darijan

    2015-12-01

    Active video games (AVGs) transform the sedentary screen time of video gaming into active screen time and have great potential to serve as a "gateway" tool to a more active lifestyle for the least active individuals. This pilot randomized trial was conducted to explore the potential of theory-guided active video games in increasing moderate-to-vigorous physical activity (MVPA) among young adults. In this pilot 4-week intervention, participants were randomly assigned to 1 of the following groups: an AVG group with all the self determination theory (SDT)-based game features turned off, an AVG group with all the SDT-based game features turned on, a passive gameplay group with all the SDT-based game features turned on, and a control group. Physical activity was measured using ActiGraph GT3X accelerometers. Other outcomes included attendance and perceived need satisfaction of autonomy, competence and relatedness. It was found that playing the self-determination theory supported AVG resulted in greater MVPA compared with the control group immediately postintervention. The AVG with the theory-supported features also resulted in greater attendance and psychological need satisfaction than the non-theory-supported one. An AVG designed with motivation theory informed features positively impacted attendance and MVPA immediately postintervention, suggesting that including AVG features guided with motivation theory may be a method of addressing common problems with adherence and increasing effectiveness of active gaming. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  12. Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

    PubMed

    Rutledge, Thomas; Nidich, Sanford; Schneider, Robert H; Mills, Paul J; Salerno, John; Heppner, Pia; Gomez, Mayra A; Gaylord-King, Carolyn; Rainforth, Maxwell

    2014-09-01

    Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD. Published by Elsevier Inc.

  13. Spinal Motion and Muscle Activity during Active Trunk Movements – Comparing Sheep and Humans Adopting Upright and Quadrupedal Postures

    PubMed Central

    Valentin, Stephanie; Licka, Theresia F.

    2016-01-01

    Sheep are used as models for the human spine, yet comparative in vivo data necessary for validation is limited. The purpose of this study was therefore to compare spinal motion and trunk muscle activity during active trunk movements in sheep and humans. Three-dimensional kinematic data as well as surface electromyography (sEMG) of spinal flexion and extension was compared in twenty-four humans in upright (UR) and 4-point kneeling (KN) postures and in 17 Austrian mountain sheep. Kinematic markers were attached over the sacrum, posterior iliac spines, and spinous and transverse processes of T5, T8, T11, L2 and L5 in humans and over the sacrum, tuber sacrale, T5, T8, T12, L3 and L7 in sheep. The activity of erector spinae (ES), rectus abdominis (RA), obliquus externus (OE), and obliquus internus (OI) were collected. Maximum sEMG (MOE) was identified for each muscle and trial, and reported as a percentage (MOE%) of the overall maximally observed sEMG from all trials. Spinal range of motion was significantly smaller in sheep compared to humans (UR / KN) during flexion (sheep: 6–11°; humans 12–34°) and extension (sheep: 4°; humans: 11–17°). During extension, MOE% of ES was greater in sheep (median: 77.37%) than UR humans (24.89%), and MOE% of OE and OI was greater in sheep (OE 76.20%; OI 67.31%) than KN humans (OE 21.45%; OI 19.34%), while MOE% of RA was lower in sheep (21.71%) than UR humans (82.69%). During flexion, MOE% of RA was greater in sheep (83.09%) than humans (KN 47.42%; UR 41.38%), and MOE% of ES in sheep (45.73%) was greater than KN humans (14.45%), but smaller than UR humans (72.36%). The differences in human and sheep spinal motion and muscle activity suggest that caution is warranted when ovine data are used to infer human spine biomechanics. PMID:26741136

  14. Activity groups for people with schizophrenia: a randomized controlled trial.

    PubMed

    Dean, Madeleine; Weston, Adam R W; Osborn, David P; Willis, Suzie; Patterson, Sue; Killaspy, Helen; Leurent, Baptiste; Crawford, Mike J

    2014-08-01

    UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score = -6.0, 95% CI -2.3 to -9.8) but global functioning did not (change in GAF score = 0.8, 95% CI -1.7 to 3.3). No significant differences were found between treatment arms. Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.

  15. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization.

    PubMed

    Brown, Alexandra R; Gajewski, Byron J; Aaronson, Lauren S; Mudaranthakam, Dinesh Pal; Hunt, Suzanne L; Berry, Scott M; Quintana, Melanie; Pasnoor, Mamatha; Dimachkie, Mazen M; Jawdat, Omar; Herbelin, Laura; Barohn, Richard J

    2016-08-31

    In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization. A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites. This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application. ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014.

  16. Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials.

    PubMed

    Hindryckx, Pieter; Levesque, Barrett G; Holvoet, Tom; Durand, Serina; Tang, Ceen-Ming; Parker, Claire; Khanna, Reena; Shackelton, Lisa M; D'Haens, Geert; Sandborn, William J; Feagan, Brian G; Lebwohl, Benjamin; Leffler, Daniel A; Jairath, Vipul

    2018-01-01

    Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted measure of disease activity used in clinical trials. We conducted a systematic review of coeliac disease activity indices to evaluate their operating properties and potential as outcome measures in registration trials. MEDLINE, EMBASE and the Cochrane central library were searched from 1966 to 2015 for eligible studies in adult and/or paediatric patients with coeliac disease that included coeliac disease activity markers in their outcome measures. The operating characteristics of histological indices, patient-reported outcomes (PROs) and endoscopic indices were evaluated for content and construct validity, reliability, responsiveness and feasibility using guidelines proposed by the US Food and Drug Administration (FDA). Of 19 123 citations, 286 studies were eligible, including 24 randomised-controlled trials. Three of five PROs identified met most key evaluative criteria but only the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient-Reported Outcome (CeD PRO) have been approved by the FDA. All histological and endoscopic scores identified lacked content validity. Quantitative morphometric histological analysis had better reliability and responsiveness compared with qualitative scales. Endoscopic indices were infrequently used, and only one index demonstrated responsiveness to effective therapy. Current best evidence suggests that the CDSD and the CeD PRO are appropriate for use in the definition of primary end points in coeliac disease registration trials. Morphometric histology should be included as a key secondary or co-primary end point. Further work is needed to optimise end point configuration to inform efficient drug development. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  17. Active learning on the ward: outcomes from a comparative trial with traditional methods.

    PubMed

    Melo Prado, Hegla; Hannois Falbo, Gilliatt; Rodrigues Falbo, Ana; Natal Figueirôa, José

    2011-03-01

    Academic activity during internship is essentially practical and ward rounds are traditionally considered the cornerstone of clinical education. However, the efficacy and effectiveness of ward rounds for learning purposes have been under-investigated and it is necessary to assess alternative educational paradigms for this activity. This study aimed to compare the educational effectiveness of ward rounds conducted with two different learning methodologies. Student subjects were first tested on 30 true/false questions to assess their initial degree of knowledge on pneumonia and diarrhoea. Afterwards, they attended ward rounds conducted using an active and a traditional learning methodology. The participants were submitted to a second test 48hours later in order to assess knowledge acquisition and were asked to answer two questions about self-directed learning and their opinions on the two learning methodologies used. Seventy-two medical students taking part in a paediatric clinic rotation were enrolled. The active methodology proved to be more effective than the traditional methodology for the three outcomes considered: knowledge acquisition (33 students [45.8%] versus 21 students [29.2%]; p=0.03); self-directed learning (38 students [52.8%] versus 11 students [15.3%]; p<0.001), and student opinion on the methods (61 students [84.7%] versus 38 students [52.8%]; p<0.001). The active methodology produced better results than the traditional methodology in a ward-based context. This study seems to be valuable in terms of the new evidence it demonstrates on learning methodologies in the context of the ward round. © Blackwell Publishing Ltd 2011.

  18. Challenges in the design and implementation of the Multicenter Uveitis Steroid Treatment (MUST) Trial--lessons for comparative effectiveness trials.

    PubMed

    Holbrook, Janet T; Kempen, John H; Prusakowski, Nancy A; Altaweel, Michael M; Jabs, Douglas A

    2011-12-01

    Randomized clinical trials (RCTs) are an important component of comparative effectiveness (CE) research because they are the optimal design for head-to-head comparisons of different treatment options. To describe decisions made in the design of the Multicenter Uveitis Steroid Treatment (MUST) Trial to ensure that the results would be widely generalizable. Review of design and implementation decisions and their rationale for the trial. The MUST Trial is a multicenter randomized controlled CE trial evaluating a novel local therapy (intraocular fluocinolone acetonide implant) versus the systemic therapy standard of care for noninfectious uveitis. Decisions made in protocol design in order to broaden enrollment included allowing patients with very poor vision and media opacity to enroll and including clinical sites outside the United States. The treatment protocol was designed to follow standard care. The primary outcome, visual acuity, is important to patients and can be evaluated in all eyes with uveitis. Other outcomes include patient-reported visual function, quality of life, and disease and treatment related complications. The trial population is too small for subgroup analyses that are of interest and the trial is being conducted at tertiary medical centers. CE trials require greater emphasis on generalizability than many RCTs but otherwise face similar challenges for design choices as any RCT. The increase in heterogeneity in patients and treatment required to ensure generalizability can be balanced with a rigorous approach to implementation, outcome assessment, and statistical design. This approach requires significant resources that may limit implementation in many RCTs, especially in clinical practice settings.

  19. A randomized controlled trial comparing 2 interventions for visual field loss with standard occupational therapy during inpatient stroke rehabilitation.

    PubMed

    Mödden, Claudia; Behrens, Marion; Damke, Iris; Eilers, Norbert; Kastrup, Andreas; Hildebrandt, Helmut

    2012-06-01

    Compensatory and restorative treatments have been developed to improve visual field defects after stroke. However, no controlled trials have compared these interventions with standard occupational therapy (OT). A total of 45 stroke participants with visual field defect admitted for inpatient rehabilitation were randomized to restorative computerized training (RT) using computer-based stimulation of border areas of their visual field defects or to a computer-based compensatory therapy (CT) teaching a visual search strategy. OT, in which different compensation strategies were used to train for activities of daily living, served as standard treatment for the active control group. Each treatment group received 15 single sessions of 30 minutes distributed over 3 weeks. The primary outcome measures were visual field expansion for RT, visual search performance for CT, and reading performance for both treatments. Visual conjunction search, alertness, and the Barthel Index were secondary outcomes. Compared with OT, CT resulted in a better visual search performance, and RT did not result in a larger expansion of the visual field. Intragroup pre-post comparisons demonstrated that CT improved all defined outcome parameters and RT several, whereas OT only improved one. CT improved functional deficits after visual field loss compared with standard OT and may be the intervention of choice during inpatient rehabilitation. A larger trial that includes lesion location in the analysis is recommended.

  20. Randomised trials comparing different healthcare settings: an exploratory review of the impact of pre-trial preferences on participation, and discussion of other methodological challenges.

    PubMed

    Corbett, Mark S; Watson, Judith; Eastwood, Alison

    2016-10-19

    We recently published a systematic review of different healthcare settings (such as outpatient, community or home) for administering intravenous chemotherapy, and concluded that performing conventionally designed randomised trials was difficult. The main problems were achieving adequate trial accrual rates and recruiting a study population which adequately represented the target population of interest. These issues stemmed from the fact that potential participants may have had pre-trial perceptions about the trial settings they may be allocated; such preferences will sometimes be strong enough for patients to decline an invitation to participate in a trial. A patient preference trial design (in which patients can choose, or be randomised to, an intervention) may have obviated these recruitment issues, although none of the trials used such a design. In order to gain a better understanding of the broader prevalence and extent of these preference issues (and any other methodological challenges), we undertook an exploratory review of settings trials in any area of healthcare treatment research. We searched The Cochrane Library and Google Scholar and used snowballing methods to identify trials comparing different healthcare settings. Trial accrual was affected by patient preferences for a setting in 15 of the 16 identified studies; birth setting trials were the most markedly affected, with between 68 % and 85 % of eligible women declining to participate specifically because of preference for a particular healthcare setting. Recruitment into substance abuse and chemotherapy setting studies was also notably affected by preferences. Only four trials used a preference design: the proportion of eligible patients choosing to participate via a preference group ranged from between 33 % and 67 %. In trials of healthcare settings, accrual may be seriously affected by patient preferences. The use of trial designs which incorporate a preference component should therefore strongly

  1. The role of randomized cluster crossover trials for comparative effectiveness testing in anesthesia: design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial.

    PubMed

    Spence, Jessica; Belley-Côté, Emilie; Lee, Shun Fu; Bangdiwala, Shrikant; Whitlock, Richard; LeManach, Yannick; Syed, Summer; Lamy, Andre; Jacobsohn, Eric; MacIsaac, Sarah; Devereaux, P J; Connolly, Stuart

    2018-07-01

    Increasingly, clinicians and researchers recognize that studies of interventions need to evaluate not only their therapeutic efficacy (i.e., the effect on an outcome in ideal, controlled settings) but also their real-world effectiveness in broad, unselected patient groups. Effectiveness trials inform clinical practice by comparing variations in therapeutic approaches that fall within the standard of care. In this article, we discuss the need for studies of comparative effectiveness in anesthesia and the limitations of individual patient randomized-controlled trials in determining comparative effectiveness. We introduce the concept of randomized cluster crossover trials as a means of answering questions of comparative effectiveness in anesthesia, using the design of the Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial (Clinicaltrials.gov identifier NCT03053869).

  2. The Devon Active Villages Evaluation (DAVE) trial of a community-level physical activity intervention in rural south-west England: a stepped wedge cluster randomised controlled trial.

    PubMed

    Solomon, Emma; Rees, Tim; Ukoumunne, Obioha C; Metcalf, Brad; Hillsdon, Melvyn

    2014-07-18

    The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health. In light of this, researchers have called for more community-level interventions. The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities. 128 rural villages (clusters) were randomised to receive the intervention in one of four time periods between April 2011 and December 2012. The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups, including at least three different types of activities per village. Each village received an individually tailored intervention, incorporating a local needs-led approach. Support was provided for a further 12 months following the intervention. The evaluation study used a stepped wedge cluster randomised controlled trial design. All 128 villages were measured at each of five data collection periods using a postal survey. The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines. Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome. To compare between intervention and control modes, random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively. 10,412 adults (4693 intervention, 5719 control) completed the postal survey (response rate 32.2%). The intervention did not increase the odds of adults meeting the physical activity guideline (adjusted OR 1.02, 95% CI: 0.88 to 1.17; P = 0.80), although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week (adjusted mean difference = 171, 95% CI: -16 to 358; P = 0.07). The ineffectiveness of the intervention may

  3. A Comparative Effectiveness Education Trial for Lifestyle Health Behavior Change in African Americans

    ERIC Educational Resources Information Center

    Halbert, Chanita Hughes; Bellamy, Scarlett; Briggs, Vanessa; Delmoor, Ernestine; Purnell, Joseph; Rogers, Rodney; Weathers, Benita; Johnson, Jerry C.

    2017-01-01

    Obesity and excess weight are significant clinical and public health issues that disproportionately affect African Americans because of physical inactivity and unhealthy eating. We compared the effects of alternate behavioral interventions on obesity-related health behaviors. We conducted a comparative effectiveness education trial in a…

  4. A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial.

    PubMed

    Piccini, Jonathan P; Connolly, Stuart J; Abraham, William T; Healey, Jeff S; Steinberg, Benjamin A; Al-Khalidi, Hussein R; Dignacco, Patricia; van Veldhuisen, Dirk J; Sauer, William H; White, Michel; Wilton, Stephen B; Anand, Inder S; Dufton, Christopher; Marshall, Debra A; Aleong, Ryan G; Davis, Gordon W; Clark, Richard L; Emery, Laura L; Bristow, Michael R

    2018-05-01

    Few therapies are available for the safe and effective treatment of atrial fibrillation (AF) in patients with heart failure. Bucindolol is a non-selective beta-blocker with mild vasodilator activity previously found to have accentuated antiarrhythmic effects and increased efficacy for preventing heart failure events in patients homozygous for the major allele of the ADRB1 Arg389Gly polymorphism (ADRB1 Arg389Arg genotype). The safety and efficacy of bucindolol for the prevention of AF or atrial flutter (AFL) in these patients has not been proven in randomized trials. The Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Metoprolol Succinate for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure (GENETIC-AF) trial is a multicenter, randomized, double-blinded "seamless" phase 2B/3 trial of bucindolol hydrochloride versus metoprolol succinate, for the prevention of symptomatic AF/AFL in patients with reduced ejection fraction heart failure (HFrEF). Patients with pre-existing HFrEF and recent history of symptomatic AF are eligible for enrollment and genotype screening, and if they are ADRB1 Arg389Arg, eligible for randomization. A total of approximately 200 patients will comprise the phase 2B component and if pre-trial assumptions are met, 620 patients will be randomized at approximately 135 sites to form the Phase 3 population. The primary endpoint is the time to recurrence of symptomatic AF/AFL or mortality over a 24-week follow-up period, and the trial will continue until 330 primary endpoints have occurred. GENETIC-AF is the first randomized trial of pharmacogenetic guided rhythm control, and will test the safety and efficacy of bucindolol compared with metoprolol succinate for the prevention of recurrent symptomatic AF/AFL in patients with HFrEF and an ADRB1 Arg389Arg genotype. (ClinicalTrials.govNCT01970501). Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial.

    PubMed

    Finkelstein, Eric A; Haaland, Benjamin A; Bilger, Marcel; Sahasranaman, Aarti; Sloan, Robert A; Nang, Ei Ei Khaing; Evenson, Kelly R

    2016-12-01

    Despite the increasing popularity of activity trackers, little evidence exists that they can improve health outcomes. We aimed to investigate whether use of activity trackers, alone or in combination with cash incentives or charitable donations, lead to increases in physical activity and improvements in health outcomes. In this randomised controlled trial, employees from 13 organisations in Singapore were randomly assigned (1:1:1:1) with a computer generated assignment schedule to control (no tracker or incentives), Fitbit Zip activity tracker, tracker plus charity incentives, or tracker plus cash incentives. Participants had to be English speaking, full-time employees, aged 21-65 years, able to walk at least ten steps continuously, and non-pregnant. Incentives were tied to weekly steps, and the primary outcome, moderate-to-vigorous physical activity (MVPA) bout min per week, was measured via a sealed accelerometer and assessed on an intention-to-treat basis at 6 months (end of intervention) and 12 months (after a 6 month post-intervention follow-up period). Other outcome measures included steps, participants meeting 70 000 steps per week target, and health-related outcomes including weight, blood pressure, and quality-of-life measures. This trial is registered at ClinicalTrials.gov, number NCT01855776. Between June 13, 2013, and Aug 15, 2014, 800 participants were recruited and randomly assigned to the control (n=201), Fitbit (n=203), charity (n=199), and cash (n=197) groups. At 6 months, compared with control, the cash group logged an additional 29 MVPA bout min per week (95% CI 10-47; p=0·0024) and the charity group an additional 21 MVPA bout min per week (2-39; p=0·0310); the difference between Fitbit only and control was not significant (16 MVPA bout min per week [-2 to 35; p=0·0854]). Increases in MVPA bout min per week in the cash and charity groups were not significantly greater than that of the Fitbit group. At 12 months, the Fitbit group logged an

  6. Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

    PubMed

    Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane

    2013-07-15

    Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p < 0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.

  7. Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)

    PubMed Central

    2014-01-01

    Background About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. Methods/Design This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children’s Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children’s Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. Discussion

  8. Comparing of goal setting strategy with group education method to increase physical activity level: A randomized trial.

    PubMed

    Jiryaee, Nasrin; Siadat, Zahra Dana; Zamani, Ahmadreza; Taleban, Roya

    2015-10-01

    Designing an intervention to increase physical activity is important to be based on the health care settings resources and be acceptable by the subject group. This study was designed to assess and compare the effect of the goal setting strategy with a group education method on increasing the physical activity of mothers of children aged 1 to 5. Mothers who had at least one child of 1-5 years were randomized into two groups. The effect of 1) goal-setting strategy and 2) group education method on increasing physical activity was assessed and compared 1 month and 3 months after the intervention. Also, the weight, height, body mass index (BMI), waist and hip circumference, and well-being were compared between the two groups before and after the intervention. Physical activity level increased significantly after the intervention in the goal-setting group and it was significantly different between the two groups after intervention (P < 0.05). BMI, waist circumference, hip circumference, and well-being score were significantly different in the goal-setting group after the intervention. In the group education method, only the well-being score improved significantly (P < 0.05). Our study presented the effects of using the goal-setting strategy to boost physical activity, improving the state of well-being and decreasing BMI, waist, and hip circumference.

  9. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    PubMed

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (p<0.01) and almost identical results were observed with tears plus (difference was not statistically significant). Itone is considered to be a useful drug in computer vision syndrome.

  10. The ethics of placebo-controlled trials: a comparison of inert and active placebo controls.

    PubMed

    Edward, Sarah J L; Stevens, Andrew J; Braunholtz, David A; Lilford, Richard J; Swift, Teresa

    2005-05-01

    Because of the recent and controversial example of sham surgery for the evaluation of fetal tissue transplants for Parkinson's disease, there is renewed interest in the ethics of using "active" placebos in surgical trials, where otherwise there are no inert procedures available, and in pharmacological trials, where there are inert substances, but where patients may guess to which arm they have been allocated. This paper seeks to clarify the ethical arguments surrounding the use of active placebos in trials, and to set up a notation for assessing the ethics of trials more generally. We first establish an framework by which ethics committees can analyze such trials. We examine (1) the scientific value of the research; (2) the expected risks and benefits to individual patients, and (3) the voluntary nature of consent. We then contrast the implications of this framework for inert and active placebo-controlled trials, respectively. In particular, we analyze their relative expected utility using three main utility factors, namely, treatment effects, placebo effects, and altruism. We conclude that, when the intervention is already widely available, active placebo trials rely more heavily on altruism than do inert placebo trials and, when the intervention is restricted, this excess reliance may not be needed. What our analysis provides is the explicit justification for the apparent caution of Institutional Review Boards or ethics committees when reviewing sham operations, especially when the expected harm is not trivial and the risk of exploitation is high.

  11. Maintained physical activity and physiotherapy in the management of distal upper limb pain - a protocol for a randomised controlled trial (the arm pain trial).

    PubMed

    Jones, Gareth T; Mertens, Kathrin; Macfarlane, Gary J; Palmer, Keith T; Coggon, David; Walker-Bone, Karen; Burton, Kim; Heine, Peter J; McCabe, Candy; McNamee, Paul; McConnachie, Alex

    2014-03-10

    Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Results from this trial will contribute to the evidence base underpinning the

  12. A randomized trial comparing primary angioplasty versus stent placement for symptomatic intracranial stenosis

    PubMed Central

    Qureshi, Adnan I; Chaudhry, Saqib A; Siddiq, Farhan; Majidi, Shahram; Rodriguez, Gustavo J; Suri, M Fareed K

    2013-01-01

    Background: Both primary angioplasty alone and angioplasty with a self-expanding stent have been compared in non-randomized concurrent clinical studies that suggest equivalent results. However, there is no randomized trial that has compared the two procedures in patients with symptomatic high grade intracranial stenosis. Objective: The primary aim of the randomized trial was to compare the clinical and angiographic efficacy of primary angioplasty and angioplasty followed by stent placement in preventing restenosis, stroke, requirement for second treatment, and death in patients with symptomatic intracranial stenosis. Methods: The study prospectively evaluated efficacy and safety of the two existing neurointerventional techniques for treatment of moderate intracranial stenosis (stenosis ≥ 50%) with documented failure of medical treatment or severe stenosis (≥70%) with or without failure of medical treatment. Results: A total of 18 patients were recruited in the study (mean age [±SD] was 64.7 ± 15.1 years); out of these, 12 were men. Of these 18, 10 were treated with primary angioplasty and 8 were treated with angioplasty followed by self-expanding stent. The technical success rates of intracranial angioplasty and stent placements defined as ability to achieve <30% residual stenosis when assessed by immediate post-procedure angiography was 5 of 10 and 5 of 8 patients, respectively. The total fluoroscopic time (mean [±SD]) was lower in patients undergoing primary angioplasty 37 [±11] min versus those undergoing angioplasty followed by self-expanding stent 42 [±15] min, P = 0.4321. The stroke and death rate within 1 month was very low in both patient groups (1 of 10 versus 0 of 8 patients). One patient randomized to stent placement continued to have recurrent ischemic symptoms requiring another angioplasty in the vertebral artery on post-procedure Day 2. Conclusions: The trial suggests that a randomized trial comparing primary angioplasty to angioplasty

  13. The use of clinical trials in comparative effectiveness research on mental health.

    PubMed

    Blanco, Carlos; Rafful, Claudia; Olfson, Mark

    2013-08-01

    A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Examination of three ongoing randomized clinical trials in psychiatry addressing issues that would pose difficulties for nonexperimental CER methods. Existing statistical approaches to nonexperimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult-to-reach populations, or when examining sequential treatments or stepped-care algorithms. Progress in CER on mental health will require careful consideration of appropriate selection between clinical trials and nonexperimental designs and on allocation of research resources to optimally inform key treatment decisions for each patient. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Comparing socially disadvantaged smokers who agree and decline to participate in a randomised smoking cessation trial

    PubMed Central

    Bonevski, Billie; Twyman, Laura; Paul, Chris; D'Este, Catherine; West, Robert; Siahpush, Mohammad; Oldmeadow, Christopher; Palazzi, Kerrin; Bryant, Jamie; Guillaumier, Ashleigh

    2015-01-01

    Objectives This study examined sociodemographic, smoking and psychosocial characteristics associated with consent to participate in a smoking cessation trial for socially disadvantaged smokers. Design Baseline data were collected prior to seeking consent for the Call it Quits, a randomised controlled trial. Setting An Australian social and community service organisation. Sociodemographic, smoking and psychosocial characteristics were compared between smokers who agreed or declined to participate. Participants Of the 584 smokers invited to participate, 431 (74%) consented and 153 (26%) declined. Results Logistic regression modelling indicates the ORs of participation were twice as high for those reporting ‘high’ motivation to quit compared to the ‘moderate’ motivation group, and five times higher than the ‘low’ motivation group (p=0.007). The ORs of consenting were higher for those with a preference for gradual reduction in cigarettes in quit attempts compared with ‘no preference’. The ORs were lower for those reporting ‘don't know’ regarding their enjoyment of smoking compared to ‘not at all’ enjoying smoking, and reporting that fewer of their family or friends smoked compared to ‘most or all’. Conclusions This study is the first to examine the characteristics of socially disadvantaged smokers who consent or decline to participate in a smoking cessation trial. Low-income smokers who are motivated to quit, are not enjoying smoking, had family or friends who smoked, and who are interested in gradual cessation approaches may be more likely to participate in a smoking cessation trial. Trial registration number ISRCTN85202510. PMID:26369799

  15. Active for Life After Cancer: a randomized trial examining a lifestyle physical activity program for prostate cancer patients.

    PubMed

    Carmack Taylor, Cindy L; Demoor, Carl; Smith, Murray A; Dunn, Andrea L; Basen-Engquist, Karen; Nielsen, Ingrid; Pettaway, Curtis; Sellin, Rena; Massey, Pamela; Gritz, Ellen R

    2006-10-01

    Active for Life After Cancer is a randomized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program (Lifestyle) for prostate cancer patients to improve quality of life (QOL) including physical and emotional functioning compared to a group-based Educational Support Program and a Standard Care Program (no group). A total of 134 prostate cancer patients receiving continuous androgen-ablation were randomly assigned to one of the three study conditions. Results indicated no significant improvements in QOL at 6 or 12 months. Both group-based programs were positively received and yielded good attendance and retention. Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity. Despite these improvements, no significant changes were found for most physical activity measures. Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients.

  16. Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitis.

    PubMed

    de Bièvre, M A; Vrij, A A; Schoon, E J; Dijkstra, G; de Jong, A E; Oberndorff-Klein Woolthuis, A H; Hemker, H C; Stockbrügger, R W

    2007-06-01

    In several open and 1 controlled trial, unfractionated heparin was effective in the treatment of active ulcerative colitis (UC). Low molecular weight heparin (LMWH) had a similar effect in several open studies. We studied the efficacy, safety, and tolerability of LMWH in mild to moderately active UC in a randomized, double-blind, placebo-controlled trial. In all, 29 patients with a mild or moderate recurrence of UC during salicylate treatment were randomized to receive either reviparin 3,436 IU (n = 15) subcutaneously twice daily or placebo (n = 14). The study period was 8 weeks. Treatment was discontinued if there was no improvement at 4 weeks or at any disease progression. Primary outcome measure was clinical improvement at 8 weeks measured by the Colitis Activity Index (CAI) and the Clinical Symptoms Grading (CSG, based on the CAI). Endoscopic and histologic grading and quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) were secondary outcome measures. Patients were closely monitored for adverse events. Twenty of 29 patients finished the 8-week treatment period (reviparin versus placebo: 11 versus 9; P = 0.70). There was no difference in CSG, CAI, endoscopic and histologic grading, or IBDQ. Treatment was well tolerated and no serious adverse events occurred. In this study, treatment with LMWH showed no significant clinical advantage compared to placebo in mild to moderately active UC.

  17. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial.

    PubMed

    Montoy, Juan Carlos C; Dow, William H; Kaplan, Beth C

    2016-01-19

    What is the effect of default test offers--opt-in, opt-out, and active choice--on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department? This was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection. 38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected. Active choice is a distinct test regimen, with test acceptance patterns that may best approximate patients' true preferences. Opt-out regimens can substantially increase HIV testing, and opt

  18. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial

    PubMed Central

    Dow, William H; Kaplan, Beth C

    2016-01-01

    Study question What is the effect of default test offers—opt-in, opt-out, and active choice—on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department? Methods This was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection. Study answer and limitations 38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected. What this paper adds Active choice is a distinct test regimen, with test acceptance patterns that may best approximate patients’ true

  19. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

    PubMed Central

    2011-01-01

    Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and m

  20. The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion The TOPSHOCK study is the

  1. Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

    PubMed

    Pandis, Nikolaos; Shamseer, Larissa; Kokich, Vincent G; Fleming, Padhraig S; Moher, David

    2014-09-01

    To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up

    PubMed Central

    2014-01-01

    Background Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children’s cancer treatment. Methods The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children’s perceptions of the most enjoyable activation methods are explored through an interview at 2 months. Discussion This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. Trial registration ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012). PMID:24708773

  3. Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial.

    PubMed

    Ussher, Michael; Aveyard, Paul; Manyonda, Isaac; Lewis, Sarah; West, Robert; Lewis, Beth; Marcus, Bess; Taylor, Adrian H; Barton, Pelham; Coleman, Tim

    2012-10-04

    Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy. ISRCTN48600346.

  4. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt

    PubMed Central

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-01-01

    Objectives Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness. Setting Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)). Participants 460 participants (46.6% female; 13.2 (0.4) years old). Interventions 8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition. Primary and secondary outcome measures Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline. Results All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive ‘fun’; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1

  5. Psychological impact of screening for type 2 diabetes: controlled trial and comparative study embedded in the ADDITION (Cambridge) randomised controlled trial.

    PubMed

    Eborall, Helen C; Griffin, Simon J; Prevost, A Toby; Kinmonth, Ann-Louise; French, David P; Sutton, Stephen

    2007-09-08

    To quantify the psychological impact of primary care based stepwise screening for type 2 diabetes. Controlled trial and comparative study embedded in a randomised controlled trial. 15 practices (10 screening, five control) in the ADDITION (Cambridge) trial in the east of England. 7380 adults (aged 40-69) in the top fourth for risk of having undiagnosed type 2 diabetes (6416 invited for screening, 964 controls). Invited for screening for type 2 diabetes or not invited (controls), incorporating a comparative study of subgroups of screening attenders. Attenders completed questionnaires after a random blood glucose test and at 3-6 months and 12-15 months later. Controls were sent questionnaires at corresponding time points. Non-attenders were sent questionnaires at 3-6 months and 12-15 months. State anxiety (Spielberger state anxiety inventory), anxiety and depression (hospital anxiety and depression scale), worry about diabetes, and self rated health. No significant differences were found between the screening and control participants at any time-for example, difference in means (95% confidence intervals) for state anxiety after the initial blood glucose test was -0.53, -2.60 to 1.54, at 3-6 months was 1.51 (-0.17 to 3.20), and at 12-15 months was 0.57, -1.11 to 2.24. After the initial test, compared with participants who screened negative, those who screened positive reported significantly poorer general health (difference in means -0.19, -0.25 to -0.13), higher state anxiety (0.93, -0.02 to 1.88), higher depression (0.32, 0.08 to 0.56), and higher worry about diabetes (0.25, 0.09 to 0.41), although effect sizes were small. Small but significant trends were found for self rated health across the screening subgroups at 3-6 months (P=0.047) and for worry about diabetes across the screen negative groups at 3-6 months and 12-15 months (P=0.001). Screening for type 2 diabetes has limited psychological impact on patients. Implementing a national screening programme based

  6. Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

    PubMed

    Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

    2016-04-11

    Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  7. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

    PubMed

    Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen

    2016-08-03

    Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660

  8. Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for smoking cessation during

  9. Activity Increase Despite Arthritis (AIDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946].

    PubMed

    Williams, Nefyn H; Amoakwa, Elvis; Burton, Kim; Hendry, Maggie; Belcher, John; Lewis, Ruth; Hood, Kerenza; Jones, Jeremy; Bennett, Paul; Edwards, Rhiannon T; Neal, Richard D; Andrew, Glynne; Wilkinson, Clare

    2009-09-04

    Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity. This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months. We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial

  10. Comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: a randomized trial

    USDA-ARS?s Scientific Manuscript database

    Background: Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. Objective: To compare Tai Chi with standard physical therapy f...

  11. A cluster-randomized controlled trial of strategies to increase adolescents' physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP) trial.

    PubMed

    Rosenkranz, Richard R; Lubans, David R; Peralta, Louisa R; Bennie, Andrew; Sanders, Taren; Lonsdale, Chris

    2012-10-01

    The physical activity (PA) levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE) programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children's motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT), on PA levels, and their hypothesized antecedents, during year 8 PE lessons. This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16) and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1) explaining the relevance of activities; (2) providing choice from PA options selected by the teacher; (3) providing equipment and free choice of activities; or (4) usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested within teachers as a random effect. Study

  12. The use of clinical trials in comparative effectiveness research on mental health

    PubMed Central

    Blanco, Carlos; Rafful, Claudia; Olfson, Mark

    2013-01-01

    Objectives A large body of research on comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. Study Design and Setting Examination of three ongoing randomized clinical trials in psychiatry that address issues which would pose difficulties for non-experimental CER methods. Results Existing statistical approaches to non-experimental data appear insufficient to compensate for biases that may arise when the pattern of missing data cannot be properly modeled such as when there are no standards for treatment, when affected populations have limited access to treatment, or when there are high rates of treatment dropout. Conclusions Clinical trials should retain an important role in CER, particularly in cases of high disorder prevalence, large expected effect sizes, difficult to reach populations or when examining sequential treatments or stepped-care algorithms. Progress in CER in mental health will require careful consideration of appropriate selection between clinical trials and non-experimental designs and on allocation of research resources to optimally inform key treatment decisions for each individual patient. PMID:23849150

  13. Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial).

    PubMed

    Fieten, Karin B; Zijlstra, Wieneke T; van Os-Medendorp, Harmieke; Meijer, Yolanda; Venema, Monica Uniken; Rijssenbeek-Nouwens, Lous; l'Hoir, Monique P; Bruijnzeel-Koomen, Carla A; Pasmans, Suzanne G M A

    2014-03-26

    About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking. This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters. The results of this trial will provide

  14. Recruitment to publicly funded trials--are surgical trials really different?

    PubMed

    Cook, Jonathan A; Ramsay, Craig R; Norrie, John

    2008-09-01

    Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

  15. A randomized trial comparing treatments for varicose veins.

    PubMed

    Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

    2014-09-25

    Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001). Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

  16. Physical activity reduces fatigue in patients with cancer and hematopoietic stem cell transplant recipients: A systematic review and meta-analysis of randomized trials.

    PubMed

    Oberoi, Sapna; Robinson, Paula D; Cataudella, Danielle; Culos-Reed, S Nicole; Davis, Hailey; Duong, Nathan; Gibson, Faith; Götte, Miriam; Hinds, Pamela; Nijhof, Sanne L; Tomlinson, Deborah; van der Torre, Patrick; Cabral, Sandra; Dupuis, L Lee; Sung, Lillian

    2018-02-01

    Objective was to determine whether physical activity reduces the severity of fatigue in patients with cancer or hematopoietic stem cell transplant (HSCT) recipients. We conducted a meta-analysis of randomized trials comparing physical activity with control interventions for the management of fatigue in patients with cancer or HSCT recipients. There were 170 trials included. Physical activity reduced the severity of fatigue when compared to all control groups (standardized mean difference -0.49, 95% confidence interval -0.60 to -0.37; P < 0.00001). Aerobic, neuromotor, resistance and combination exercises were all effective in reducing fatigue although smaller effects were observed with resistance exercises (P interaction = 0.01). Other intervention and patient characteristics did not influence the effect of physical activity on the severity of fatigue. Physical activity was effective at reducing fatigue in patients with cancer and HSCT recipients across patient sub-groups. Determining the best approaches for safe implementation should be a priority. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    PubMed Central

    Heukelbach, Jorg; Pilger, Daniel; Oliveira, Fabíola A; Khakban, Adak; Ariza, Liana; Feldmeier, Hermann

    2008-01-01

    Background Infestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group. Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709. PMID:18783606

  18. Activities of Tannins--From In Vitro Studies to Clinical Trials.

    PubMed

    Sieniawska, Elwira

    2015-11-01

    Tannins are considered as valuable plant secondary metabolites providing many benefits for human health. In this review information was gathered about bioactivity in vitro and in vivo, as well as about conducted clinical trials. The literature research was based on ScienceDirect, Scopus, and Cochrane databases and presents a wide range of tested activities of tannins. The described clinical trials verify laboratory tests and show the effective health benefits taken from supplementation with tannins.

  19. The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial.

    PubMed

    Oliveira, Crystian B; Franco, Márcia R; Maher, Chris G; Tiedemann, Anne; Silva, Fernanda G; Damato, Tatiana M; Nicholas, Michael K; Christofaro, Diego G D; Pinto, Rafael Z

    2018-01-15

    Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programmes for chronic LBP is that these programmes are not designed to change patients' behaviour toward an active lifestyle. Therefore, we will investigate the short- and long-term efficacy of a multimodal intervention, consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability, in patients with chronic, nonspecific LBP. This study will be a two-group, single-blind, randomised controlled trial. One hundred and sixty adults with chronic, nonspecific LBP will be recruited. Participants allocated to both groups will receive a group exercise programme. In addition, the intervention group will receive health coaching sessions (i.e. assisting the participants to achieve their physical activity goals) and an activity monitor (i.e. Fitbit Flex). The participants allocated to the control group will receive sham health coaching (i.e. encouraged to talk about their LBP or other problems, but without any therapeutic advice from the physiotherapist) and a sham activity monitor. Outcome measures will be assessed at baseline and at 3, 6 and 12 months post randomisation. The primary outcomes will be physical activity, measured objectively with an accelerometer, as well as pain intensity and disability at 3 months post randomisation. Secondary outcomes

  20. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial

    PubMed Central

    Ruotsalainen, Heidi; Kyngäs, Helvi; Tammelin, Tuija; Heikkinen, Hanna; Kääriäinen, Maria

    2015-01-01

    Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13–16-year-old adolescents. Methods. Three-arm randomized controlled trial. Participants (n = 46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act, n = 15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb, n = 16) and a third group served as the control group (n = 15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used. Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p = 0.021), but there was no interaction between time and group. Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifier NCT02295761 (2014-11-17). PMID:26697218

  1. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial.

    PubMed

    Ruotsalainen, Heidi; Kyngäs, Helvi; Tammelin, Tuija; Heikkinen, Hanna; Kääriäinen, Maria

    2015-01-01

    Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13-16-year-old adolescents. Methods. Three-arm randomized controlled trial. Participants (n = 46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act, n = 15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb, n = 16) and a third group served as the control group (n = 15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used. Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p = 0.021), but there was no interaction between time and group. Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifier NCT02295761 (2014-11-17).

  2. Timely publication and sharing of trial data: opportunities and challenges for comparative effectiveness research in cardiovascular disease.

    PubMed

    Naci, Huseyin; Cooper, Jacob; Mossialos, Elias

    2015-11-01

    There is growing enthusiasm for the timely publication and sharing of clinical trial data. The rationale for open access includes greater transparency, reproducibility, and efficiency of the research enterprise. In cardiovascular diseases, routinely sharing clinical trial data would create opportunities for undertaking comparative effectiveness research, providing much needed evidence on how different interventions compare to each other on key outcomes. Access to individual patient-level data would strengthen the validity of such research. Novel methodological approaches like network meta-analyses using individual patient-level data could reliably compare interventions that have not been compared with each other in head-to-head trials. However, there are significant practical, methodological, financial, and legal challenges to this utopian open access that need to be continually addressed. Sharing clinical trial data openly will only occur when the previously tolerated process of clinical research involving direct ownership and secrecy is abandoned for a new culture in which medical science is open to all of its stakeholders. With this new culture, data will be accessible, reanalysis will be considered commonplace, and comparative effectiveness research through novel synthesis approaches, such as network meta-analyses, can thrive-as long as measures are taken to adequately ensure the goal remains to promote public health.

  3. A randomized controlled pilot trial of classroom-based mindfulness meditation compared to an active control condition in sixth-grade children.

    PubMed

    Britton, Willoughby B; Lepp, Nathaniel E; Niles, Halsey F; Rocha, Tomas; Fisher, Nathan E; Gold, Jonathan S

    2014-06-01

    The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure -Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities. Copyright © 2014 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

  4. Efficacy and Mediation of a Theory-Based Physical Activity Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial.

    PubMed

    Zhang, Jingwen; Jemmott, John B; O'Leary, Ann; Stevens, Robin; Jemmott, Loretta Sweet; Icard, Larry D; Hsu, Janet; Rutledge, Scott E

    2017-02-01

    Few trials have tested physical-activity interventions among sexual minorities, including African American men who have sex with men (MSM). We examined the efficacy and mediation of the Being Responsible for Ourselves (BRO) physical-activity intervention among African American MSM. African American MSM were randomized to the physical-activity intervention consisting of three 90-min one-on-one sessions or an attention-matched control intervention and completed pre-intervention, immediately post-intervention, and 6- and 12-month post-intervention audio computer-based surveys. Of the 595 participants, 503 completed the 12-month follow-up. Generalized estimating equation models revealed that the intervention increased self-reported physical activity compared with the control intervention, adjusted for pre-intervention physical activity. Mediation analyses suggested that the intervention increased reasoned action approach variables, subjective norm and self-efficacy, increasing intention immediately post-intervention, which increased physical activity during the follow-up period. Interventions targeting reasoned action approach variables may contribute to efforts to increase African American MSM's physical activity. The trial was registered with the ClinicalTrials.gov Identifier NCT02561286 .

  5. Increased error-related thalamic activity during early compared to late cocaine abstinence.

    PubMed

    Li, Chiang-Shan R; Luo, Xi; Sinha, Rajita; Rounsaville, Bruce J; Carroll, Kathleen M; Malison, Robert T; Ding, Yu-Shin; Zhang, Sheng; Ide, Jaime S

    2010-06-01

    Altered cognitive control is implicated in the shaping of cocaine dependence. One of the key component processes of cognitive control is error monitoring. Our previous imaging work highlighted greater activity in distinct cortical and subcortical regions including the dorsal anterior cingulate cortex (dACC), thalamus and insula when participants committed an error during the stop signal task (Li et al., 2008b). Importantly, dACC, thalamic and insular activity has been associated with drug craving. One hypothesis is that the intense interoceptive activity during craving prevents these cerebral structures from adequately registering error and/or monitoring performance. Alternatively, the dACC, thalamus and insula show abnormally heightened responses to performance errors, suggesting that excessive responses to salient stimuli such as drug cues could precipitate craving. The two hypotheses would each predict decreased and increased activity during stop error (SE) as compared to stop success (SS) trials in the SST. Here we showed that cocaine dependent patients (PCD) experienced greater subjective feeling of loss of control and cocaine craving during early (average of day 6) compared to late (average of day 18) abstinence. Furthermore, compared to PCD during late abstinence, PCD scanned during early abstinence showed increased thalamic as well as insular but not dACC responses to errors (SE>SS). These findings support the hypothesis that heightened thalamic reactivity to salient stimuli co-occur with cocaine craving and loss of self control. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

  6. Challenges and lessons learned in conducting comparative-effectiveness trials.

    PubMed

    Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

    2012-05-01

    The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

  7. Double-blind comparative trial of indoprofen and acetylsalicylic acid in osteoarthritis.

    PubMed

    Katona, G

    1981-01-01

    The effectiveness, safety and acceptability of indoprofen (IP) and acetylsalicylic acid (ASA) were assessed in patients with osteoarthritis, in a double-blind comparative trial. Each patient received IP 600 mg/day or ASA 2100 mg/day for a four-week period; after a one-week wash-out period, the same drug was given at a higher dosage (IP 800 or ASA 2800 mg/day) for another four weeks. Seventeen patients on indoprofen and 14 on SAS completed the trial. A significant improvement was obtained with indoprofen in the different parameters measuring pain, from the first treatment period; results were similar at the end of the second period. Results with ASA, at both dosages, appeared less impressive. Two patients on indoprofen and five on ASA complained of side effects.

  8. Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database

    PubMed Central

    Turner, Erick H.; Knoepflmacher, Daniel; Shapley, Lee

    2012-01-01

    Background Publication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy. Methods and Findings FDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant. Conclusions The magnitude of publication bias found for antipsychotics was less than that found

  9. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial.

    PubMed

    Marciniak, Christina M; Toledo, Santiago; Lee, Jungwha; Jesselson, Michael; Bateman, Jillian; Grover, Benjamin; Tierny, Joy

    2014-11-21

    To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids. In this double blind, randomized, active comparator trial, adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone (Amitza(®)), orally twice a day or Senna (generic) two capsules administered daily for six days. Subjects were assessed using the patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) scales measured at baseline and Day 7; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency, specific bowel symptom score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed), adverse events and rescue medications required. Function was measured using the functional independence measure (FIM) at admission and discharge; length of stay (LOS) and missed treatments due to gastrointestinal symptoms were also assessed. 64 adults were enrolled; 56 participants (28 in each group) had baseline and follow up measures and were included in the intention to treat (ITT) analyses. 43 participants completed the study, 21 in the active lubiprostone and 22 in the active Senna group. The mean age of the participants was 71.5 years (SD = 11.4 years, range: 28-96 years). In the ITT analyses, participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean ± SD, -0.28 ± 0.60, range: -1-2.33) and PAC-QOL (mean ± SD, 0.33 ± 0.81, range: -1.5-2.0) over time, but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) or the PAC-QOL (0.29 ± 0.76 vs 0.37 ± 0.87, P = 0.61 respectively). The mean change in each bowel symptom

  10. Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: A double-blind, active-comparator trial

    PubMed Central

    Marciniak, Christina M; Toledo, Santiago; Lee, Jungwha; Jesselson, Michael; Bateman, Jillian; Grover, Benjamin; Tierny, Joy

    2014-01-01

    AIM: To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids. METHODS: In this double blind, randomized, active comparator trial, adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone (Amitza®), orally twice a day or Senna (generic) two capsules administered daily for six days. Subjects were assessed using the patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) scales measured at baseline and Day 7; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency, specific bowel symptom score (Nausea, cramping, straining, completeness, abdominal pain, time per lavatory attempt, assistance needed), adverse events and rescue medications required. Function was measured using the functional independence measure (FIM) at admission and discharge; length of stay (LOS) and missed treatments due to gastrointestinal symptoms were also assessed. RESULTS: 64 adults were enrolled; 56 participants (28 in each group) had baseline and follow up measures and were included in the intention to treat (ITT) analyses. 43 participants completed the study, 21 in the active lubiprostone and 22 in the active Senna group. The mean age of the participants was 71.5 years (SD = 11.4 years, range: 28-96 years). In the ITT analyses, participants showed significant improvement in bowel symptoms as measured by the PAC-SYM (mean ± SD, -0.28 ± 0.60, range: -1-2.33) and PAC-QOL (mean ± SD, 0.33 ± 0.81, range: -1.5-2.0) over time, but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM (-0.20 ± 0.60 vs -0.36 ± 0.61, P = 0.61 respectively) or the PAC-QOL (0.29 ± 0.76 vs 0.37 ± 0.87, P = 0.61 respectively). The mean change in

  11. Impact of Personalised Feedback about Physical Activity on Change in Objectively Measured Physical Activity (the FAB Study): A Randomised Controlled Trial

    PubMed Central

    Godino, Job G.; Watkinson, Clare; Corder, Kirsten; Marteau, Theresa M.; Sutton, Stephen; Sharp, Stephen J.; Griffin, Simon J.; van Sluijs, Esther M. F.

    2013-01-01

    Background Low levels of physical activity are a major public health concern, and interventions to promote physical activity have had limited success. Whether or not personalised feedback about physical activity following objective measurement motivates behaviour change has yet to be rigorously examined. Methods And Findings: In a parallel group, open randomised controlled trial, 466 healthy adults aged 32 to 54 years were recruited from the ongoing population-based Fenland Study (Cambridgeshire, UK). Participants were randomised to receive either no feedback until the end of the trial (control group, n=120) or one of three different types of feedback: simple, visual, or contextualised (intervention groups, n=346). The primary outcome was physical activity (physical activity energy expenditure (PAEE) in kJ/kg/day and average body acceleration (ACC) in m/s2) measured objectively using a combined heart rate monitor and accelerometer (Actiheart®). The main secondary outcomes included self-reported physical activity, intention to increase physical activity, and awareness of physical activity (the agreement between self-rated and objectively measured physical activity). At 8 weeks, 391 (83.9%) participants had complete physical activity data. The intervention had no effect on objectively measured physical activity (PAEE: β=-0.92, 95% CI=-3.50 to 1.66, p=0.48 and ACC: β=0.01, 95% CI=-0.00 to 0.02, p=0.21), self-reported physical activity (β=-0.39, 95% CI=-1.59 to 0.81), or intention to increase physical activity (β=-0.05, 95% CI=-0.22 to 0.11). However, it was associated with an increase in awareness of physical activity (OR=1.74, 95% CI=1.05 to 2.89). Results did not differ according to the type of feedback. Conclusions Personalised feedback about physical activity following objective measurement increased awareness but did not result in changes in physical activity in the short term. Measurement and feedback may have a role in promoting behaviour change but are

  12. Challenges and Lessons Learned in Conducting Comparative-Effectiveness Trials

    PubMed Central

    Herrick, Linda M.; Locke, G. Richard; Zinsmeister, Alan R.; Talley, Nicholas J.

    2014-01-01

    The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication. PMID:22552235

  13. A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc).

    PubMed

    Farrand, Paul; Pentecost, Claire; Greaves, Colin; Taylor, Rod S; Warren, Fiona; Green, Colin; Hillsdon, Melvyn; Evans, Phil; Welsman, Jo; Taylor, Adrian H

    2014-05-29

    Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health. This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with physical activity promotion, depressed adults are randomised to receive up to 12 sessions over a maximum of 4 months of either BAcPAc or behavioural activation alone within a written self-help format, which represents treatment as usual. The study is located within two 'Improving Access to Psychological Therapies' services in South West England, with both written self-help interventions supported by mental health paraprofessionals. Measures assessed at 4, 9, and 12 month follow-up include the following: CIS-R, PHQ-9, accelerometer recorded (4 months only) and self-reported PA, body mass index, blood pressure, Insomnia Severity Index, quality of life, and health and social care service use. Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews. At the time of writing the study has recruited 60 patients. The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self

  14. PRIVATE MANUFACTURERS’ THRESHOLDS TO INVEST IN COMPARATIVE EFFECTIVENESS TRIALS

    PubMed Central

    Basu, Anirban; Meltzer, David

    2015-01-01

    The recent rush of enthusiasm for public investment in comparative effectiveness research (CER) in the United States has focused attention on these public investments. However, little attention has been given to how changing public investment in CER may affect private manufacturers’ incentives for CER, which has long been a major source of CER. In this work, based on a simple revenue maximizing economic framework, we generate predictions on thresholds to invest in CER for a private manufacturer that compares its own product to its competitor’s in head to head trials. Our analysis shows that private incentives to invest in CER are determined by how the results of CER may affect the price and quantity of the product sold and the duration over which resulting changes in revenue would accrue given the time required to complete CER and the time from the completion of CER to the time of patent expiration. We highlight the result that private incentives may often be less than public incentives to invest in CER and may even be negative if the likelihood of adverse findings is sufficient. We find that these incentives imply a number of predictions about patterns of CER and how they will be affected by changes in public financing of CER and CER methods. For example, these incentives imply that incumbent patent holders may be less likely to invest in CER than entrants and that public investments in CER may crowd out similar private investments. In contrast, newer designs and methods for CER, such as Bayesian adaptive trials, which can reduce ex-post risk of unfavorable results and shorten the time for the production of CER, may increase the expected benefits of CER and may tend to increase private investment in CER as long as the costs of such innovative designs are not excessive. Bayesian approaches to design also naturally highlight the dynamic aspects of CER, allowing less expensive initial studies to guide decisions about future investments and thereby encouraging

  15. Private manufacturers' thresholds to invest in comparative effectiveness trials.

    PubMed

    Basu, Anirban; Meltzer, David

    2012-10-01

    The recent rush of enthusiasm for public investment in comparative effectiveness research (CER) in the US has focussed attention on these public investments. However, little attention has been given to how changing public investment in CER may affect private manufacturers' incentives for CER, which has long been a major source of CER. In this work, based on a simple revenue maximizing economic framework, we generate predictions on thresholds to invest in CER for a private manufacturer that compares its own product to a competitor's product in head-to-head trials. Our analysis shows that private incentives to invest in CER are determined by how the results of CER may affect the price and quantity of the product sold and the duration over which resulting changes in revenue would accrue, given the time required to complete CER and the time from the completion of CER to the time of patent expiration. We highlight the result that private incentives may often be less than public incentives to invest in CER and may even be negative if the likelihood of adverse findings is sufficient. We find that these incentives imply a number of predictions about patterns of CER and how they will be affected by changes in public financing of CER and CER methods. For example, these incentives imply that incumbent patent holders may be less likely to invest in CER than entrants and that public investments in CER may crowd out similar private investments. In contrast, newer designs and methods for CER, such as Bayesian adaptive trials, which can reduce ex post risk of unfavourable results and shorten the time for the production of CER, may increase the expected benefits of CER and may tend to increase private investment in CER as long as the costs of such innovative designs are not excessive. Bayesian approaches to design also naturally highlight the dynamic aspects of CER, allowing less expensive initial studies to guide decisions about future investments and thereby encouraging greater

  16. Enhanced platelet/endothelial activation in depressed patients with acute coronary syndromes: evidence from recent clinical trials.

    PubMed

    Serebruany, Victor L; Glassman, Alexander H; Malinin, Alex I; Sane, David C; Finkel, Mitchell S; Krishnan, Ranga R; Atar, Dan; Lekht, Vladimir; O'Connor, Christopher M

    2003-09-01

    Platelets play a key role in the progression of acute coronary syndromes (ACS). Clinical depression alone is also associated with enhanced platelet activation. The purpose of this study was to compare concentrations of established biomarkers of enhanced platelet/endothelial activation in clinically depressed versus non-depressed patients enrolled in recent clinical trials for ACS. Two hundred and eighty-one baseline plasma samples from patients with acute myocardial infarction (ASSENT-2; n = 41), with ACS (PRONTO; n = 126) and with clinical depression plus previous acute coronary syndrome within 6 months (SADHART; n = 64), and from normal healthy controls (n = 50) were analyzed. Blood was drawn before applying any therapeutic strategies including interventions, thrombolytics, infusions, and selective serotonin re-uptake inhibitors. Platelet factor 4, beta-thromboglobulin, platelet/endothelial cell adhesion molecule-1, P-selectin, thromboxane, prostacyclin, vascular cell adhesion molecule-1, and E-selectin were measured by enzyme-linked immunosorbent assay by a single core laboratory. Patients with ACS exhibited a higher degree of platelet activation than controls independently of the presence of depression. Plasma levels of P-selectin, thromboxane, prostacyclin, and vascular cell adhesion molecule-1 were the highest in the acute myocardial infarction group when compared with ACS despite the presence or absence of clinical depression. Surprisingly, patients with ACS and depression exhibited the highest levels of platelet factor 4, beta-thromboglobulin, and platelet/endothelial cell adhesion molecule-1 when compared with myocardial infarction or angina patients without clinical depression. E-selectin plasma level was constantly elevated compared with controls but did not differ among the groups dependent on the incidence of depression. The depressed plus ACS group had higher plasma levels of all biomarkers compared with the non-depressed patients. Retrospective

  17. Classroom Application of a Trial-Based Functional Analysis

    ERIC Educational Resources Information Center

    Bloom, Sarah E.; Iwata, Brian A.; Fritz, Jennifer N.; Roscoe, Eileen M.; Carreau, Abbey B.

    2011-01-01

    We evaluated a trial-based approach to conducting functional analyses in classroom settings. Ten students referred for problem behavior were exposed to a series of assessment trials, which were interspersed among classroom activities throughout the day. Results of these trial-based functional analyses were compared to those of more traditional…

  18. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

    PubMed Central

    Smolen, Josef S.; Choe, Jung-Yoon; Prodanovic, Nenad; Niebrzydowski, Jaroslaw; Staykov, Ivan; Dokoupilova, Eva; Baranauskaite, Asta; Yatsyshyn, Roman; Mekic, Mevludin; Porawska, Wieskawa; Ciferska, Hana; Jedrychowicz-Rosiak, Krystyna; Zielinska, Agnieszka; Choi, Jasmine; Rho, Young Hee

    2017-01-01

    Abstract Objectives SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. Methods In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. Results A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. Conclusion SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37) PMID:28957563

  19. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

    PubMed Central

    2011-01-01

    Background In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. Methods/Design The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission. During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective. Discussion The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis. Trial Registration ISRCTN: ISRCTN18170985 PMID:21392395

  20. In vitro activity of tigecycline and comparator agents against a global collection of Gram-negative and Gram-positive organisms: tigecycline Evaluation and Surveillance Trial 2004 to 2007.

    PubMed

    Garrison, Mark W; Mutters, Reinier; Dowzicky, Michael J

    2009-11-01

    The Tigecycline Evaluation and Surveillance Trial began in 2004 to monitor the in vitro activity of tigecycline and comparator agents against a global collection of Gram-negative and Gram-positive pathogens. Against Gram negatives (n = 63 699), tigecycline MIC(90)'s ranged from 0.25 to 2 mg/L for Escherichia coli, Haemophilus influenzae, Acinetobacter baumannii, Klebsiella oxytoca, Enterobacter cloacae, Klebsiella pneumoniae, and Serratia marcescens (but was > or =32 for Pseudomonas aeruginosa). Against Gram-positive organisms (n = 32 218), tigecycline MIC(90)'s were between 0.06 and 0.25 mg/L for Streptococcus pneumoniae, Enterococcus faecium, Streptococcus agalactiae, Staphylococcus aureus, and Enterococcus faecalis. The in vitro activity of tigecycline was maintained against resistant phenotypes, including multidrug-resistant A. baumannii (9.2% of isolates), extended-spectrum beta-lactamase-producing E. coli (7.0%) and K. pneumoniae (14.0%), beta-lactamase-producing H. influenzae (22.2%), methicillin-resistant S. aureus (44.5%), vancomycin-resistant E. faecium (45.9%) and E. faecalis (2.8%), and penicillin-resistant S. pneumoniae (13.8%). Tigecycline represents a welcome addition to the armamentarium against difficult to treat organisms.

  1. Effect of theory-based intervention to promote physical activity among adolescent girls: a randomized control trial

    PubMed Central

    Darabi, Fatemeh; Kaveh, Mohammad Hossein; Majlessi, Fereshteh; Farahani, Farideh Khalaj Abadi; Yaseri, Mehdi; Shojaeizadeh, Davoud

    2017-01-01

    Background Physical activity (PA) rates decline among most high school female students, and due to cultural restrictions, the reduction of physical activity might be exacerbated in female Iranian adolescents. Objective To determine the effects of the physical activity education theory-based intervention to promote activity among adolescent girls. Methods This randomized clinical trial was conducted at public high schools in Tehran, Iran, from September 2015 to July 2016 on 578 girls. The subjects were assigned randomly to two groups of experiment and control (n=289 per group). All participants in the experimental group received an educational program based on a modified TPB. Measures were assessed before and 6 months after the experiment. The data were analyzed using SPSS version 23. We used descriptive statistics, multilevel analysis, Likelihood Ratio (LR) test, P-value less than 0.05 were considered statistically significant. Results Five hundred and seventy-eight participants with a mean age of 14.26±0.96 years were studied in two groups of experiment (n=289) and control (n=289). Moreover, adjusted for the baseline values, the mean of the scores of the knowledge (84.1±13.6), attitude (31.2±13.6), subjective norm (40.4±11.1), behavioral intention (34.3±14.7), perceived behavioral control (38.4±11.6), perceived parental control (42.9±14.2), behavioral (42.6±17.1) was significantly higher in the experiment group compared with the control group (p<0.001). Conclusions The results of this study implicate that theory based educational intervention is considered to be more effective in improving physical activity in adolescents. This result can be used to increase adolescent’s health promotion. Trial registration The trial was registered at the Iranian Registry of Clinical Trials (IRST) with the identification number: IRCT2015070623089N2. Funding The authors received no financial support for the research from Kermanshah University of Medical Sciences. PMID

  2. Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

    USDA-ARS?s Scientific Manuscript database

    OBJECTIVE: To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. DESIGN: Multicenter, single blinded randomized trial (Lifestyle Interventions and ...

  3. A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial.

    PubMed

    Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory

    2017-10-01

    Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    PubMed

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  5. An overview of “The Active by Choice Today” (ACT) trial for increasing physical activity✩

    PubMed Central

    Wilson, Dawn K.; Kitzman-Ulrich, Heather; Williams, Joel E.; Saunders, Ruth; Griffin, Sarah; Pate, Russell; Van Horn, M. Lee; Evans, Alexandra; Hutto, Brent; Addy, Cheryl L.; Mixon, Gary; Sisson, Susan B.

    2008-01-01

    Background: Although school-based behavioral interventions for increasing physical activity (PA) in children and adolescents have been conducted, little evidence suggests that these curriculum-based approaches lead to increases in overall activity outside of program days. The overall goal of the “Active by Choice Today” (ACT) trial is to expand the body of knowledge concerning the factors that influence long-term increases in PA in underserved adolescents (low socioeconmic status, minorities) during their middle school years. Design and setting: An overview of the ACT study design, theoretical framework, process evaluation, and primary hypotheses is presented. The trial involves twenty-four middle schools (1560 6th graders) in South Carolina that are randomly assigned to one of two after-school programs (motivational and life skills intervention, or general health education). Intervention: The intervention integrates constructs from Self-Determination and Social Cognitive Theories to enhance intrinsic motivation and behavioral skills for PA. The intervention targets skill development for PA outside of program days and the after-school program social environment (autonomy, choice, participation, belongingness, fun, enjoyment, support) is designed to positively impact cognitive mediators (self-efficacy, perceived competence), and motivational orientation (intrinsic motivation, commitment, positive self-concept). Main hypotheses/outcomes: It is hypothesized that the 17-week motivational and life skills intervention will lead to greater increases in moderate-to-vigorous PA (based on 7-day accelerometry estimates) at post-intervention as compared to the general health education program. Conclusions: Implications of this innovative school-based trial are discussed. PMID:17716952

  6. Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial

    PubMed Central

    Hassett, Leanne; van den Berg, Maayken; Lindley, Richard I; Crotty, Maria; McCluskey, Annie; van der Ploeg, Hidde P; Smith, Stuart T; Schurr, Karl; Killington, Maggie; Bongers, Bert; Howard, Kirsten; Heritier, Stephane; Togher, Leanne; Hackett, Maree; Treacy, Daniel; Dorsch, Simone; Wong, Siobhan; Scrivener, Katharine; Chagpar, Sakina; Weber, Heather; Pearson, Ross; Sherrington, Catherine

    2016-01-01

    Introduction People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. Methods and analysis A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an

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

    PubMed

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

    2018-01-22

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

  8. Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

    PubMed Central

    Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

    2015-01-01

    . Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

  9. A randomized controlled trial of an online, modular, active learning training program for behavioral activation for depression.

    PubMed

    Puspitasari, Ajeng J; Kanter, Jonathan W; Busch, Andrew M; Leonard, Rachel; Dunsiger, Shira; Cahill, Shawn; Martell, Christopher; Koerner, Kelly

    2017-08-01

    This randomized-controlled trial assessed the efficacy of a trainer-led, active-learning, modular, online behavioral activation (BA) training program compared with a self-paced online BA training with the same modular content. Seventy-seven graduate students (M = 30.3 years, SD = 6.09; 76.6% female) in mental health training programs were randomly assigned to receive either the trainer-led or self-paced BA training. Both trainings consisted of 4 weekly sessions covering 4 core BA strategies. Primary outcomes were changes in BA skills as measured by an objective role-play assessment and self-reported use of BA strategies. Assessments were conducted at pre-, post-, and 6-weeks after training. A series of longitudinal mixed effect models assessed changes in BA skills and a longitudinal model implemented with generalized estimating equations assessed BA use over time. Significantly greater increases in total BA skills were found in the trainer-led training condition. The trainer-led training condition also showed greater increases in all core BA skills either at posttraining, follow-up, or both. Reported use of BA strategies with actual clients increased significantly from pre- to posttraining and maintained at follow-up in both training conditions. This trial adds to the literature on the efficacy of online training as a method to disseminate BA. Online training with an active learning, modular approach may be a promising and accessible implementation strategy. Additional strategies may need to be paired with the online BA training to assure the long-term implementation and sustainability of BA in clinical practice. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  10. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up.

    PubMed

    Kauhanen, Lotta; Järvelä, Liisa; Lähteenmäki, Päivi M; Arola, Mikko; Heinonen, Olli J; Axelin, Anna; Lilius, Johan; Vahlberg, Tero; Salanterä, Sanna

    2014-04-05

    Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children's cancer treatment. The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children's perceptions of the most enjoyable activation methods are explored through an interview at 2 months. This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012).

  11. A cluster randomised trial of a school-based intervention to prevent decline in adolescent physical activity levels: study protocol for the ‘Physical Activity 4 Everyone’ trial

    PubMed Central

    2013-01-01

    Background Adolescence is an established period of physical activity decline. Multi-component school-based interventions have the potential to slow the decline in adolescents’ physical activity; however, few interventions have been conducted in schools located in low-income or disadvantaged communities. This study aims to assess the effectiveness of a multi-component school-based intervention in reducing the decline in physical activity among students attending secondary schools located in disadvantaged communities. Methods/Design The cluster randomised trial will be conducted with 10 secondary schools located in selected regions of New South Wales, Australia. The schools will be selected from areas that have a level of socio-economic status that is below the state average. Five schools will be allocated to receive an intervention based on the Health Promoting Schools framework, and will be supported by a part-time physical activity consultant placed in intervention schools who will implement a range of intervention adoption strategies. Study measures will be taken at baseline when students are in Year 7 (12–13 years) and again after 12- and 24-months. The primary outcome, minutes of moderate- to-vigorous- intensity physical activity per day and percentage of time in moderate- to vigorous-intensity physical activity (MVPA), will be objectively assessed using accelerometers (Actigraph GT3x+). Group allocation and intervention delivery will commence after baseline data collection. The intervention will continue during school terms through to 24-month follow-up. Discussion The study will provide evidence regarding the effectiveness of a multi-component school-based intervention that includes an in-school physical activity consultant targeting the physical activity levels of adolescents in disadvantaged Australian secondary schools. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000382875. PMID:23336603

  12. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial

    PubMed Central

    Ly, Kien Hoa; Topooco, Naira; Cederlund, Hanna; Wallin, Anna; Bergström, Jan; Molander, Olof; Carlbring, Per; Andersson, Gerhard

    2015-01-01

    Background There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment - including four face-to-face sessions and a smartphone application - was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression. Methods This was a randomised controlled non-inferiority trial (NCT01819025) comparing a blended treatment (n=46) against a full ten-session treatment (n=47) for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment. Results Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen’s d=1.35; CI [−0.82, 3.52] to d=1.47; CI [−0.41, 3.35]; between group d=−0.13 CI [−2.37, 2.09] and d=−0.10 CI [−2.53, 2.33]). At the same time, the blended treatment reduced the therapist time with an average of 47%. Conclusions We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone applica¬tion as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression. Trial Registration Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025 PMID:26010890

  13. Randomized Trial of Behavioral Activation, Cognitive Therapy, and Antidepressant Medication in the Prevention of Relapse and Recurrence in Major Depression

    ERIC Educational Resources Information Center

    Dobson, Keith S.; Hollon, Steven D.; Dimidjian, Sona; Schmaling, Karen B.; Kohlenberg, Robert J.; Gallop, Robert J.; Rizvi, Shireen L.; Gollan, Jackie K.; Dunner, David L.; Jacobson, Neil S.

    2008-01-01

    This study followed treatment responders from a randomized controlled trial of adults with major depression. Patients treated with medication but withdrawn onto pill-placebo had more relapse through 1 year of follow-up compared to patients who received prior behavioral activation, prior cognitive therapy, or continued medication. Prior…

  14. [Effects of organic selenium supplement on glutathione peroxidase activities: a meta-analysis of randomized controlled trials].

    PubMed

    Jiang, Xia; Dong, Jiayi; Wang, Bo; Yin, Xuebin; Qin, Liqiang

    2012-01-01

    To study the effects of organic selenium supplementation on glutathione peroxidase (GPx) activities. Randomized controlled trials (RCT) published from January 1988 to December 2010 on the relationship between organic selenium supplementation and GPx activities were collected. Meta-analysis was applied to estimate the combined standardized mean difference (SMD) and 95% confidence interval (95% CI). A total of 10 RCTs were included. The number of studies observing GPx activities in plasma, erythrocyte and platelet was 8, 5 and 5, respectively. Compared with the controls, the combined SMD (95% CI) of GPx activities in plasma, erythrocyte and platelet of subjects supplemented with organic selenium was 0.46 (0.09 - 0.83), 0.36 (0.02 - 0.69) and 0.56 (-0.02 - 1.15). Supplementation with organic selenium increases GPx activities in healthy adults.

  15. GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

    PubMed Central

    2014-01-01

    Background Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT. Methods/design A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation. Discussion This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD. Trial registration German Clinical Trial Registration (DRKS): DRKS00005025 PMID:24476555

  16. Acquisition of an instrumental activity of daily living in patients with Korsakoff's syndrome: a comparison of trial and error and errorless learning.

    PubMed

    Oudman, Erik; Nijboer, Tanja C W; Postma, Albert; Wijnia, Jan W; Kerklaan, Sandra; Lindsen, Karen; Van der Stigchel, Stefan

    2013-01-01

    Patients with Korsakoff's syndrome show devastating amnesia and executive deficits. Consequently, the ability to perform instrumental activities such as making coffee is frequently diminished. It is currently unknown whether patients with Korsakoff's syndrome are able to (re)learn instrumental activities. A good candidate for an effective teaching technique in Korsakoff's syndrome is errorless learning as it is based on intact implicit memory functioning. Therefore, the aim of the current study was two-fold: to investigate whether patients with Korsakoff's syndrome are able to (re)learn instrumental activities, and to compare the effectiveness of errorless learning with trial and error learning in the acquisition and maintenance of an instrumental activity, namely using a washing machine to do the laundry. Whereas initial learning performance in the errorless learning condition was superior, both intervention techniques resulted in similar improvement over eight learning sessions. Moreover, performance in a different spatial layout showed a comparable improvement. Notably, in follow-up sessions starting after four weeks without practice, performance was still elevated in the errorless learning condition, but not in the trial and error condition. The current study demonstrates that (re)learning and maintenance of an instrumental activity is possible in patients with Korsakoff's syndrome.

  17. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    PubMed

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  18. Early ART After Cryptococcal Meningitis Is Associated With Cerebrospinal Fluid Pleocytosis and Macrophage Activation in a Multisite Randomized Trial

    PubMed Central

    Scriven, James E.; Rhein, Joshua; Hullsiek, Katherine Huppler; von Hohenberg, Maximilian; Linder, Grace; Rolfes, Melissa A.; Williams, Darlisha A.; Taseera, Kabanda; Meya, David B.; Meintjes, Graeme; Boulware, David R.

    2015-01-01

    Introduction. Earlier antiretroviral therapy (ART) initiation in cryptococcal meningitis resulted in higher mortality compared with deferred ART initiation (1–2 weeks vs 5 weeks postmeningitis diagnosis). We hypothesized this was due to ART-associated immune pathology, without clinically recognized immune reconstitution inflammatory syndrome. Methods. Three macrophage activation markers and 19 cytokines/chemokines were measured from cryopreserved cerebrospinal fluid (CSF) and serum during the Cryptococcal Optimal ART Timing (COAT) trial. Comparisons were made between trial arms (early vs deferred) at 1, 8, 14, and 21 days following meningitis diagnosis. Results. More participants with early ART initiation had CSF white cell count (WCC) ≥5/µL at day 14 (58% vs 40%; P = .047), after a median of 6-days ART. Differences were mainly driven by participants with CSF WCC <5/µL at meningitis diagnosis: 28% (10/36) of such persons in the early ART group had CSF WCC ≥5/µL by day 14, compared with 0% (0/27) in the deferred arm (P = .002). Furthermore, Kampala participants (the largest site) receiving early ART had higher day-14 CSF levels of interleukin-13 (P = .04), sCD14 (P = .04), sCD163 (P = .02), and CCL3/MIP-1α (P = .02), suggesting increased macrophage/microglial activation. Conclusions. Early ART initiation in cryptococcal meningitis increased CSF cellular infiltrate, macrophage/microglial activation, and T helper 2 responses within the central nervous system. This suggests that increased mortality from early ART in the COAT trial was immunologically mediated. PMID:25651842

  19. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol.

    PubMed

    Fukuoka, Yoshimi; Komatsu, Judith; Suarez, Larry; Vittinghoff, Eric; Haskell, William; Noorishad, Tina; Pham, Kristin

    2011-12-14

    Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth. ClinicalTrials.gov#:NCTO1280812.

  20. Manual therapy compared with physical therapy in patients with non-specific neck pain: a randomized controlled trial.

    PubMed

    Groeneweg, Ruud; van Assen, Luite; Kropman, Hans; Leopold, Huco; Mulder, Jan; Smits-Engelsman, Bouwien C M; Ostelo, Raymond W J G; Oostendorp, Rob A B; van Tulder, Maurits W

    2017-01-01

    Manual therapy according to the School of Manual Therapy Utrecht (MTU) is a specific type of passive manual joint mobilization. MTU has not yet been systematically compared to other manual therapies and physical therapy. In this study the effectiveness of MTU is compared to physical therapy, particularly active exercise therapy (PT) in patients with non-specific neck pain. Patients neck pain, aged between 18-70 years, were included in a pragmatic randomized controlled trial with a one-year follow-up. Primary outcome measures were global perceived effect and functioning (Neck Disability Index), the secondary outcome was pain intensity (Numeric Rating Scale for Pain). Outcomes were measured at 3, 7, 13, 26 and 52 weeks. Multilevel analyses (intention-to-treat) were the primary analyses for overall between-group differences. Additional to the primary and secondary outcomes the number of treatment sessions of the MTU group and PT group was analyzed. Data were collected from September 2008 to February 2011. A total of 181 patients were included. Multilevel analyses showed no statistically significant overall differences at one year between the MTU and PT groups on any of the primary and secondary outcomes. The MTU group showed significantly lower treatment sessions compared to the PT group (respectively 3.1 vs. 5.9 after 7 weeks; 6.1 vs. 10.0 after 52 weeks). Patients with neck pain improved in both groups without statistical significantly or clinically relevant differences between the MTU and PT groups during one-year follow-up. ClinicalTrials.gov Identifier: NCT00713843.

  1. Statistical Frequency-Dependent Analysis of Trial-to-Trial Variability in Single Time Series by Recurrence Plots.

    PubMed

    Tošić, Tamara; Sellers, Kristin K; Fröhlich, Flavio; Fedotenkova, Mariia; Beim Graben, Peter; Hutt, Axel

    2015-01-01

    For decades, research in neuroscience has supported the hypothesis that brain dynamics exhibits recurrent metastable states connected by transients, which together encode fundamental neural information processing. To understand the system's dynamics it is important to detect such recurrence domains, but it is challenging to extract them from experimental neuroscience datasets due to the large trial-to-trial variability. The proposed methodology extracts recurrent metastable states in univariate time series by transforming datasets into their time-frequency representations and computing recurrence plots based on instantaneous spectral power values in various frequency bands. Additionally, a new statistical inference analysis compares different trial recurrence plots with corresponding surrogates to obtain statistically significant recurrent structures. This combination of methods is validated by applying it to two artificial datasets. In a final study of visually-evoked Local Field Potentials in partially anesthetized ferrets, the methodology is able to reveal recurrence structures of neural responses with trial-to-trial variability. Focusing on different frequency bands, the δ-band activity is much less recurrent than α-band activity. Moreover, α-activity is susceptible to pre-stimuli, while δ-activity is much less sensitive to pre-stimuli. This difference in recurrence structures in different frequency bands indicates diverse underlying information processing steps in the brain.

  2. Statistical Frequency-Dependent Analysis of Trial-to-Trial Variability in Single Time Series by Recurrence Plots

    PubMed Central

    Tošić, Tamara; Sellers, Kristin K.; Fröhlich, Flavio; Fedotenkova, Mariia; beim Graben, Peter; Hutt, Axel

    2016-01-01

    For decades, research in neuroscience has supported the hypothesis that brain dynamics exhibits recurrent metastable states connected by transients, which together encode fundamental neural information processing. To understand the system's dynamics it is important to detect such recurrence domains, but it is challenging to extract them from experimental neuroscience datasets due to the large trial-to-trial variability. The proposed methodology extracts recurrent metastable states in univariate time series by transforming datasets into their time-frequency representations and computing recurrence plots based on instantaneous spectral power values in various frequency bands. Additionally, a new statistical inference analysis compares different trial recurrence plots with corresponding surrogates to obtain statistically significant recurrent structures. This combination of methods is validated by applying it to two artificial datasets. In a final study of visually-evoked Local Field Potentials in partially anesthetized ferrets, the methodology is able to reveal recurrence structures of neural responses with trial-to-trial variability. Focusing on different frequency bands, the δ-band activity is much less recurrent than α-band activity. Moreover, α-activity is susceptible to pre-stimuli, while δ-activity is much less sensitive to pre-stimuli. This difference in recurrence structures in different frequency bands indicates diverse underlying information processing steps in the brain. PMID:26834580

  3. Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs: A Methodological Systematic Review

    PubMed Central

    van der Meersch, Amélie; Dechartres, Agnès; Ravaud, Philippe

    2011-01-01

    Background Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective To assess the quality of reporting of bioequivalence trials comparing generic to brand-name drugs. Methodology/Principal Findings PubMed was searched for reports of bioequivalence trials comparing generic to brand-name drugs between January 2005 and December 2008. Articles were included if the aim of the study was to assess the bioequivalency of generic and brand-name drugs. We excluded case studies, pharmaco-economic evaluations, and validation dosage assays of drugs. We evaluated whether important information about funding, methodology, location of trials, and participants were reported. We also assessed whether the criteria required by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) to conclude bioequivalence were reported and that the conclusions were in agreement with the results. We identified 134 potentially relevant articles but eliminated 55 because the brand-name or generic drug status of the reference drug was unknown. Thus, we evaluated 79 articles. The funding source and location of the trial were reported in 41% and 56% of articles, respectively. The type of statistical analysis was reported in 94% of articles, but the methods to generate the randomization sequence and to conceal allocation were reported in only 15% and 5%, respectively. In total, 65 articles of single-dose trials (89%) concluded bioequivalence. Of these, 20 (31%) did not report the 3 criteria within the limits required by the FDA and 11 (17%) did not report the 2 criteria within the limits required by the EMA. Conclusions/Significance Important information to judge the validity and relevance of results are frequently missing in published reports of trials assessing generic drugs. The quality of reporting of such trials is in need of improvement. PMID:21858184

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

    PubMed

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

    2012-08-01

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

  5. The efficacy of behavioural activation treatment for co-occurring depression and substance use disorder (the activate study): a randomized controlled trial.

    PubMed

    Ross, Joanne; Teesson, Maree; Lejuez, Carl; Mills, Katherine; Kaye, Sharlene; Brady, Kathleen; Dore, Glenys; Prior, Katrina; Larkin, Xanthe; Cassar, Joanne; Ewer, Philippa; Memedovic, Sonja; Kihas, Ivana; Masters, Sarah Louise

    2016-07-08

    Epidemiological studies suggest that compared with the general population, mood disorders are up to 4.7 times more prevalent in substance dependent samples. Comorbid substance use disorder (SUD) and depression has been associated with a more severe and protracted illness course and poorer treatment outcomes. Despite this, the development and assessment of behavioural interventions for treating depression among individuals with SUDs have received little empirical attention. Behavioural Activation Treatment for Depression (BATD-R) is an empirically supported treatment for depression that has shown some efficacy among substance users. This paper describes the study protocol of a parallel, single blind, randomised controlled trial to determine the efficacy and feasibility of a modified version of the BATD-R (Activate) in reducing symptoms of depression and substance dependence among individuals in residential rehabilitation (RR) and opioid substitution therapy (OST). A sample of approximately 200 individuals with depressive symptomatology in treatment for SUD will be recruited from RR and OST services in New South Wales, Australia. Dynamic random allocation following minimisation methodology will be used to assign participants to one of two groups. The control group will receive treatment as usual (TAU), which will be the model of care provided in accordance with standard practice at participating RR and OST services. The intervention group will receive Activate, comprising 10 individual 60-min therapy sessions with a psychologist employed on the research team, in addition to TAU. Data collection will occur at baseline (pre-intervention), and 3-months and 12-months post baseline. The association between depression and substance dependence has been well documented, yet practical and effective treatments are scarce. The findings of the present study will contribute significantly to understanding the types of programs that are effective in treating this comorbidity. This

  6. Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

    PubMed

    Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

    2014-02-01

    understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

  7. Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

    PubMed

    Gaus, Wilhelm; Muche, Rainer

    2013-05-01

    Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Cardiovascular events in a physical activity intervention compared with a successful aging intervention: The LIFE Study randomized trial

    PubMed Central

    Dodson, John A.; Church, Timothy S.; Buford, Thomas W.; Fielding, Roger A.; Kritchevsky, Stephen; Beavers, Daniel; Pahor, Marco; Stafford, Randall S.; Szady, Anita D.; Ambrosius, Walter T.; McDermott, Mary M.

    2017-01-01

    Importance Whether sustained physical activity prevents cardiovascular disease (CVD) events in older adults is uncertain. Objective To test the hypothesis that cardiovascular morbidity and mortality was reduced in participants in a long-term physical activity program. Design, Setting, Participants The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial. Participants were recruited at 8 centers in the United States. We randomized 1635 sedentary men and women aged 70 to 89 years with Short Physical Performance Battery (SPPB) score of 9 or below, but able to walk 400 m. Interventions The PA intervention was a structured moderate intensity program, predominantly walking two times per week on site for 2.6 years on average. The SA intervention consisted of weekly health education sessions for six months, then monthly. Main Outcome Total CVD events, including fatal and non-fatal myocardial infarction (MI), angina, stroke, transient ischemic attack, and peripheral artery disease, were adjudicated by committee and silent MI was assessed by serial electrocardiograms. A limited outcome of MI, stroke, and CVD death was also studied. Outcome assessors and adjudicators were blinded to intervention assignment. Results New CVD events occurred in 14.8% (n=121/818) of PA and 13.8% (113/817) of SA participants (HR=1.10, 95%CI: 0.85 to 1.42). For the more focused combined outcome of MI, stroke or cardiovascular death, rates were 4.6% in PA and 4.5% in the SA group (HR = 1.05 (95%CI: 0.67 to 1.66). Among frailer participants with a SPPB <8, total CVD rates were 14.2% in PA vs 17.7% in SA with HR = 0.76 (95%CI: 0.52 to 1.10), compared with 15.3% vs. 10.5% with HR = 1.59 (95%CI: 1.09 to 2.30) among those with SPPB of 8 or 9 (p for interaction =0.006). With the limited endpoint, the interaction was not significant (p=0.59), with HR = 0.94 (95% CI: 0.50–1.75) for SPPB < 8 and HR = 1.20 (95% CI, 0.62–2.34) for SBBP of 8 or 9). Conclusions

  9. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials.

    PubMed

    Altman, Roy D; Devji, Tahira; Bhandari, Mohit; Fierlinger, Anke; Niazi, Faizan; Christensen, Robin

    2016-10-01

    Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm. Using a systematic review and meta-analysis, our objective was to assess the clinical benefit associated with use of IA saline in trials of IA therapies in the treatment of patients with painful knee OA. MEDLINE and Embase databases were searched for articles published up to and including August 14th, 2014. Two reviewers assessed the eligibility of potential reports and the risk of bias of included trials. We analyzed short (≤3 months) and long-term (6-12 months) pain reduction of the saline arm of included trials using standardized mean differences (SMDs; estimated assuming a null effect in a comparator group) that were combined and weighted using a random effects model. Treatment-related adverse events (AEs) were tabulated and presented using descriptive statistics. From 40 randomized controlled trials (RCTs) eligible for inclusion only 38 provided sufficient data to be included in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P < 0.001; I(2) = 50%). Long-term knee pain was significantly decreased following IA injection with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P < 0.001) with a substantial degree of inconsistency (I(2) = 74%). Overall, 29 of the included trials reported on adverse events, none of which found any serious treatment-related AEs following IA injection with saline. Pain relief observed with IA saline should prompt health care providers to consider the additional effectiveness of current IA treatments that use saline comparators in clinical studies, and challenges of

  10. The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

    PubMed

    Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

    2014-07-01

    The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design

  11. Impact of personalised feedback about physical activity on change in objectively measured physical activity (the FAB study): a randomised controlled trial.

    PubMed

    Godino, Job G; Watkinson, Clare; Corder, Kirsten; Marteau, Theresa M; Sutton, Stephen; Sharp, Stephen J; Griffin, Simon J; van Sluijs, Esther M F

    2013-01-01

    Low levels of physical activity are a major public health concern, and interventions to promote physical activity have had limited success. Whether or not personalised feedback about physical activity following objective measurement motivates behaviour change has yet to be rigorously examined. And Findings: In a parallel group, open randomised controlled trial, 466 healthy adults aged 32 to 54 years were recruited from the ongoing population-based Fenland Study (Cambridgeshire, UK). Participants were randomised to receive either no feedback until the end of the trial (control group, n=120) or one of three different types of feedback: simple, visual, or contextualised (intervention groups, n=346). The primary outcome was physical activity (physical activity energy expenditure (PAEE) in kJ/kg/day and average body acceleration (ACC) in m/s(2)) measured objectively using a combined heart rate monitor and accelerometer (Actiheart(®)). The main secondary outcomes included self-reported physical activity, intention to increase physical activity, and awareness of physical activity (the agreement between self-rated and objectively measured physical activity). At 8 weeks, 391 (83.9%) participants had complete physical activity data. The intervention had no effect on objectively measured physical activity (PAEE: β=-0.92, 95% CI=-3.50 to 1.66, p=0.48 and ACC: β=0.01, 95% CI=-0.00 to 0.02, p=0.21), self-reported physical activity (β=-0.39, 95% CI=-1.59 to 0.81), or intention to increase physical activity (β=-0.05, 95% CI=-0.22 to 0.11). However, it was associated with an increase in awareness of physical activity (OR=1.74, 95% CI=1.05 to 2.89). Results did not differ according to the type of feedback. Personalised feedback about physical activity following objective measurement increased awareness but did not result in changes in physical activity in the short term. Measurement and feedback may have a role in promoting behaviour change but are ineffective on their own

  12. Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse

    PubMed Central

    2013-01-01

    Background Tocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy. Observational and in vitro data have suggested a high level of efficacy against head louse infestation. The purpose of this investigation was to confirm the activity of tocopheryl acetate in a clinical setting in comparison with a standard widely used preparation. Methods A spray formulation containing tocopheryl acetate 20% in cyclomethicone was compared with permethrin 1% creme rinse for treatment of head louse infestation in a randomised, assessor blind, trial. Forty-five people were treated on two occasions 7 days apart. The spray was applied to dry hair for 20 minutes then washed. Participants treated with permethrin washed their hair and towel dried it before treatment for 10 minutes. Assessments were made by dry detection combing 1, 6, 9, and 14 days after first treatment. Results The tocopheryl acetate 20% spray was significantly (p = 0.033) more effective than permethrin 1%, using intention to treat worst case analysis, in which there were 13/23 (56.5%) successful treatments for tocopheryl acetate compared with 5/22 (22.7%) for permethrin. After unprecedented issues of re-infestation within households had been taken into account the underlying cure rate was 17/23 (73.9%) for tocopheryl acetate compared with 5/22 (22.7%), Odds Ratio 9.63 (95% CI, 2.46 to 37.68) (p < 0.001). Conclusions The tocopheryl acetate spray was significantly more effective than the permethrin product, was cosmetically acceptable, and not affected by current problems with resistance. Trial registration Current Controlled Trials ISRCTN45553737. PMID:24004959

  13. Single-Trial Normalization for Event-Related Spectral Decomposition Reduces Sensitivity to Noisy Trials

    PubMed Central

    Grandchamp, Romain; Delorme, Arnaud

    2011-01-01

    In electroencephalography, the classical event-related potential model often proves to be a limited method to study complex brain dynamics. For this reason, spectral techniques adapted from signal processing such as event-related spectral perturbation (ERSP) – and its variant event-related synchronization and event-related desynchronization – have been used over the past 20 years. They represent average spectral changes in response to a stimulus. These spectral methods do not have strong consensus for comparing pre- and post-stimulus activity. When computing ERSP, pre-stimulus baseline removal is usually performed after averaging the spectral estimate of multiple trials. Correcting the baseline of each single-trial prior to averaging spectral estimates is an alternative baseline correction method. However, we show that this method leads to positively skewed post-stimulus ERSP values. We eventually present new single-trial-based ERSP baseline correction methods that perform trial normalization or centering prior to applying classical baseline correction methods. We show that single-trial correction methods minimize the contribution of artifactual data trials with high-amplitude spectral estimates and are robust to outliers when performing statistical inference testing. We then characterize these methods in terms of their time–frequency responses and behavior compared to classical ERSP methods. PMID:21994498

  14. Comparative trial of treatment with Prioderm lotion and Kwellada shampoo in children with head lice.

    PubMed Central

    Mathias, R. G.; Huggins, D. R.; Leroux, S. J.; Proctor, E. M.

    1984-01-01

    The safety and efficacy of treatment with a new pediculicide lotion, Prioderm (0.5% malathion in isopropanol), were compared with those of treatment with Kwellada (1% lindane) shampoo in a randomized trial of children with head lice. The children's scalps were examined for live lice immediately, 7 days and 4 to 6 weeks following treatment. To determine the in-vitro ovicidal effect of treatment, samples of hair with nits were removed before and immediately following treatment; the subsequent rates of hatching were compared. No live lice were present immediately following either treatment. At 7 days after treatment 2 of the 29 children treated with Prioderm lotion and 4 of the 33 children treated with Kwellada shampoo were infested with live lice, whereas at 4 to 6 weeks after treatment 5 and 3 children respectively were infested. The initial effectiveness of treatment was 93% in the children treated with Prioderm lotion and 88% in those treated with Kwellada shampoo; however, a large difference in efficacy could have been missed owing to the small number of children in the study. Both preparations demonstrated in-vitro ovicidal activity, but neither totally abolished post-treatment hatching. No side effects were reported from either preparation. Because ovicidal activity was incomplete two treatments with the same pediculicides should be given about 7 days apart. PMID:6198057

  15. Internet Treatment for Depression: A Randomized Controlled Trial Comparing Clinician vs. Technician Assistance

    PubMed Central

    Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

    2010-01-01

    Background Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Question: Would guidance from a technician be as effective as guidance from a clinician? Method Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health Questionnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Conclusions Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to

  16. The effectiveness of neuro-music therapy according to the Heidelberg model compared to a single session of educational counseling as treatment for tinnitus: a controlled trial.

    PubMed

    Argstatter, Heike; Grapp, Miriam; Hutter, Elisabeth; Plinkert, Peter K; Bolay, Hans-Volker

    2015-03-01

    Tinnitus is a very common symptom, yet the quest for an effective treatment is challenging. Results from several clinical trials support the notion that neuro-music therapy is an effective means to reduce tinnitus distress with short duration and long lasting effect. However, until now, the effectiveness has not been tested in a controlled trial against an active comparator. The trial was designed as two-center, parallel intervention group controlled study with two intervention groups: Counseling (50minute individualized personal instruction) or neuro-music therapy (counseling plus eight 50-minute sessions of individualized music therapy). Data of n=290 patients suffering from chronic tinnitus were analyzed. Outcome measure was the change in Tinnitus Questionnaire Total Scores (TQ) from baseline (admission) to end of treatment. Both treatment groups achieved a statistically relevant reduction in TQ scores, though 66% of patients in the music therapy group attained a clinically meaningful improvement compared to 33% in the counseling group. A binary logistic regression revealed two variables significantly influencing therapy outcome: initial tinnitus score and type of therapy with an OR for the music therapy compared to the counseling of 4.34 (CI 2.33-8.09). Counseling is an appropriate treatment option with well above chance of improvement. The neuro-music therapy outperformed the counseling. This treatment targets the tinnitus sound itself, is short in duration, intrinsically motivating and easy to operate and thus presents a possible complement to the therapeutic spectrum in chronic tinnitus. The trial was registered at the ClinicalTrials.gov registry (ID: NCT01845155). Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Increasing activity in older adults: A review of the Look AHEAD trial

    USDA-ARS?s Scientific Manuscript database

    The importance of physical activity for healthy aging has been clearly shown. Evidence from the Look AHEAD trial, a lifestyle intervention for overweight individuals who have type 2 diabetes, provides further evidence for the importance of physical activity. Overall, this intervention provides a pot...

  18. Cardiovascular Events in a Physical Activity Intervention Compared With a Successful Aging Intervention: The LIFE Study Randomized Trial.

    PubMed

    Newman, Anne B; Dodson, John A; Church, Timothy S; Buford, Thomas W; Fielding, Roger A; Kritchevsky, Stephen; Beavers, Daniel; Pahor, Marco; Stafford, Randall S; Szady, Anita D; Ambrosius, Walter T; McDermott, Mary M

    2016-08-01

    Whether sustained physical activity prevents cardiovascular disease (CVD) events in older adults is uncertain. To test the hypothesis that cardiovascular morbidity and mortality would be reduced in participants in a long-term physical activity program. The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial. Participants were recruited at 8 centers in the United States. We randomized 1635 sedentary men and women aged 70 to 89 years with a Short Physical Performance Battery (SPPB) score of 9 or less but able to walk 400 m. The physcial activity (PA) intervention was a structured moderate-intensity program, predominantly walking 2 times per week on site for 2.6 years on average. The successful aging intervention consisted of weekly health education sessions for 6 months, then monthly. Total CVD events, including fatal and nonfatal myocardial infarction, angina, stroke, transient ischemic attack, and peripheral artery disease, were adjudicated by committee, and silent myocardial infarction was assessed by serial electrocardiograms. A limited outcome of myocardial infarction, stroke, and CVD death was also studied. Outcome assessors and adjudicators were blinded to intervention assignment. The 1635 LIFE study participants were predominantly women (67%), with a mean (SD) age of 78.7 (5.2) years; 20% were African-American, 6% were Hispanic or other race or ethnic group, and 74% were non-Latino white. New CVD events occurred in 121 of 818 PA participants (14.8%) and 113 of 817 successful aging participants (13.8%) (HR, 1.10; 95% CI, 0.85-1.42). For the more focused combined outcome of myocardial infarction, stroke, or cardiovascular death, rates were 4.6% in PA and 4.5% in the successful aging group (HR, 1.05; 95% CI, 0.67-1.66). Among frailer participants with an SPPB score less than 8, total CVD rates were 14.2% in PA vs 17.7% in successful aging (HR, 0.76; 95% CI, 0.52-1.10), compared with 15.3% vs 10.5% among those

  19. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment.

    PubMed

    Hróbjartsson, A; Gøtzsche, P C

    2001-05-24

    Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits

  20. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

    PubMed Central

    Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing

  1. Do Bayesian adaptive trials offer advantages for comparative effectiveness research? Protocol for the RE-ADAPT study

    PubMed Central

    Luce, Bryan R; Broglio, Kristine R; Ishak, K Jack; Mullins, C Daniel; Vanness, David J; Fleurence, Rachael; Saunders, Elijah; Davis, Barry R

    2013-01-01

    Background Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. Purpose Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a ‘proof of concept’ to stimulate investment in Bayesian adaptive designs for future CER trials. Methods We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT. Results We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. Limitations While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. Conclusion This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data. PMID:23983160

  2. Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial.

    PubMed

    Mitchell, Joanna; Hardeman, Wendy; Pears, Sally; Vasconcelos, Joana C; Prevost, A Toby; Wilson, Ed; Sutton, Stephen

    2016-06-27

    Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check). The Very Brief Intervention (VBI) Trial is a two parallel-group, randomised, controlled trial with 1:1 individual allocation and follow-up at 3 months. A total of 1,140 participants will be recruited from 23 primary care practices in the east of England. Participants eligible for an NHS Health Check and who are considered suitable to take part by their doctor and able to provide written informed consent are eligible for the trial. Participants are randomly assigned at the beginning of the NHS Health Check to either 1) the control arm, in which they receive only the NHS Health Check, or 2) the intervention arm, in which they receive the NHS Health Check plus 'Step It Up' (a very brief intervention that can be delivered in 5 minutes by nurses and/or healthcare assistants at the end of the Health Check). 'Step It Up' includes (1) a face-to-face discussion, including feedback on current activity level, recommendations for physical activity, and information on how to use a pedometer, set step goals, and monitor progress; (2) written material supporting the discussion and tips and links to further resources to help increase physical activity; and (3) a pedometer to wear and a step chart for monitoring progress. The primary outcome is accelerometer counts per minute at 3-month follow-up. Secondary outcomes include the time spent in the different levels of physical activity, self-reported physical activity and economic measures. Trial recruitment is underway. The VBI trial will provide evidence on the effectiveness and

  3. Using comparative effectiveness design to improve the generalizability of bipolar treatment trials data: contrasting LiTMUS baseline data with pre-existing placebo controlled trials.

    PubMed

    Friedman, E S; Calabrese, J R; Ketter, T A; Leon, A C; Thase, M E; Bowden, C L; Sylvia, L G; Ostracher, M J; Severe, J; Iosifescu, D V; Nierenberg, A A; Reilly-Harrington, N A

    2014-01-01

    Efficacy-based double-blind placebo controlled trials were conducted to establish efficacy and safety for FDA approval. Such designs allowed and encouraged the use of exclusion criteria to improve assay sensitivity and internal validity. The LiTMUS trial increased the representation of real-world individuals with bipolar disorder despite the acknowledgment that this compromises assay sensitivity. To maximize generalizability, LiTMUS used broad inclusion and narrow exclusion criteria: participants experiencing mood symptoms of sufficient intensity (at least with a CGI-BP ≥ 3) that would warrant a change in treatment, and that lithium treatment would be a reasonable therapeutic option if they were randomized to it. At baseline demographic, illness, clinical, and treatment characteristics were collected. The LiTMUS study design and baseline sociodemographic data were compared to previous efficacy studies. As compared to the previous bipolar disorder efficacy studies, LiTMUS participants were of similar age, gender, weight and illness severity; however LiTMUS participants were more racially and ethnically representative of the general population, had a greater number of mood episodes in the past 12 months, more Axis I/II comorbidity, a greater number of prior suicide attempts, and higher functional capacity. LiTMUS was a comparative effectiveness trial that had broad inclusion and minimal exclusion criteria that produced a more representative sample comprised of real-world participants. This design enables the results of the LiTMUS study to be a more representative of real world pharmacotherapuetic outcomes. Limitations include possible selection bias, paucity of sociodemographic data in efficacy trials, and lack of a placebo. Copyright © 2013. Published by Elsevier B.V.

  4. Rose-K versus Soper contact lens in keratoconus: a randomized comparative trial.

    PubMed

    Gupta, Raghav; Sinha, Rajesh; Singh, Pooja; Sharma, Namrata; Tandon, Radhika; Titiyal, Jeewan S

    2014-01-01

    To perform a comparative evaluation of the efficacy and acceptability of Rose-K and Soper contact lenses in Keratoconus. Dr. Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi. A randomized comparative clinical trial was performed in keratoconic eyes fitted with Rose-K (Rose-K group) and Soper (Soper group) contact lenses. Patients data were evaluated for best spectacle corrected visual acuity, best contact lens corrected visual acuity (BCLCVA), corneal topography, glare acuity, contrast sensitivity, tear function tests and specular microscopy. Patients were also asked to complete a self-reported comfort questionnaire at each visit. Sixty eyes were randomized to the Rose-K and Soper groups. The two groups were comparable in all the baseline parameters. There was a statistically significant improvement in BCLCVA in both groups at 3 months (P < 0.01, both groups). The difference between in BCLCVA in both groups was not statistically significant. In both groups, there was a significant improvement in the comfort score at 3 months compared to baseline (P < 0.05, both group). The Rose-K group had statistically significantly better scores at 1 and 3 months compared with the Soper group (P = 0.006 and P < 0.001 respectively). Both groups were associated with a significant (P < 0.01), but comparable improvement in glare acuity at 3 months. There was a significant improvement in contrast sensitivity at 3 months in both groups (P < 0.01); the Rose-K group was significantly better than the Soper group at 1 and 3 months (P = 0.001 and 0.002 respectively). The mean number of trial lenses required for fitting Rose-K lens (2.00 ± 0.59) was significantly lower than the Soper lens (3.43 ± 0.82; P < 0.001). Both the contact lens designs provide an equal improvement in visual acuity in patients with Keratoconus. However, Rose-K contact lens provides greater comfort, better quality of vision and requires less chair time compared with

  5. Alcohol, indomethacin, and salbutamol. A comparative trial of their use in preterm labor.

    PubMed

    Spearing, G

    1979-02-01

    In a comparative trial, ethanol effectively arrested preterm labor for 48 hours for more in 32% of cases, a beta-adrenergic agent (salbutamol) in 60% of cases (not statistically significant), and a combination of ethanol and indomethacin in 70% of cases (statistically significant, P less than 0.5). Labor was delayed for 14 days or more in 36, 60, and 50%, respectively (not statistically significant). The numbers studied were small, and tests of statistical significance were of doubtful value. Salbutamol was more acceptable to patients and the staff than ethanol. The trial was suspended and eventually abandoned due to reports of prostaglandin synthetase inhibitors causing premature closure of the ductus arteriosus. In this series no problems were encountered with the use of indomethacin.

  6. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial

    PubMed Central

    Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-01-01

    pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366239 (Archived by WebCite at http://www.webcitation.org/6ZVtu6TMz). PMID:26169067

  7. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    . The study is also among the first to examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression (that is, activity level and environmental reward) on depression over time. To our knowledge, this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed, Spanish-speaking Latinos in the United States. Trial registration Clinical Trials Register: NCT01958840; registered 8 October 2013. PMID:24938081

  8. Enhancing Cognitive Abilities with Comprehensive Training: A Large, Online, Randomized, Active-Controlled Trial

    PubMed Central

    Hardy, Joseph L.; Nelson, Rolf A.; Thomason, Moriah E.; Sternberg, Daniel A.; Katovich, Kiefer; Farzin, Faraz; Scanlon, Michael

    2015-01-01

    Background A variety of studies have demonstrated gains in cognitive ability following cognitive training interventions. However, other studies have not shown such gains, and questions remain regarding the efficacy of specific cognitive training interventions. Cognitive training research often involves programs made up of just one or a few exercises, targeting limited and specific cognitive endpoints. In addition, cognitive training studies typically involve small samples that may be insufficient for reliable measurement of change. Other studies have utilized training periods that were too short to generate reliable gains in cognitive performance. Methods The present study evaluated an online cognitive training program comprised of 49 exercises targeting a variety of cognitive capacities. The cognitive training program was compared to an active control condition in which participants completed crossword puzzles. All participants were recruited, trained, and tested online (N = 4,715 fully evaluable participants). Participants in both groups were instructed to complete one approximately 15-minute session at least 5 days per week for 10 weeks. Results Participants randomly assigned to the treatment group improved significantly more on the primary outcome measure, an aggregate measure of neuropsychological performance, than did the active control group (Cohen’s d effect size = 0.255; 95% confidence interval = [0.198, 0.312]). Treatment participants showed greater improvements than controls on speed of processing, short-term memory, working memory, problem solving, and fluid reasoning assessments. Participants in the treatment group also showed greater improvements on self-reported measures of cognitive functioning, particularly on those items related to concentration compared to the control group (Cohen’s d = 0.249; 95% confidence interval = [0.191, 0.306]). Conclusion Taken together, these results indicate that a varied training program composed of a number of

  9. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

    PubMed

    Platt, Richard; Takvorian, Samuel U; Septimus, Edward; Hickok, Jason; Moody, Julia; Perlin, Jonathan; Jernigan, John A; Kleinman, Ken; Huang, Susan S

    2010-06-01

    The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. All admissions to adult ICUs. The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. Recruitment of hospitals is complete. Data collection will end in Summer 2011. This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

  10. Traditional Indigenous Games promoting physical activity and cultural connectedness in primary schools--cluster randomised control trial.

    PubMed

    Kiran, Asha; Knights, Janice

    2010-08-01

    This study investigated the effectiveness of Traditional Indigenous Games (TIG) to improve physical activity and cultural connectedness among primary school students in the community renewal areas of Townsville in North Queensland. A cluster randomised control trial was conducted in four primary schools in 2007. Baseline and post implementation surveys were conducted in two intervention and two control schools and the results were compared. TIG delivered in primary schools every week over period of three months did not contribute to any statistically significant improvement in intervention and control groups in physical activity levels or cultural connectedness. Further research specifically in terms of intensity and duration of TIG may inform whether physical activity may be improved. Enhancing the Indigenous cultural features of the existing TIG kit might positively influence Indigenous cultural connectedness.

  11. Discrepancies between ClinicalTrials.gov recruitment status and actual trial status: a cross-sectional analysis.

    PubMed

    Jones, Christopher W; Safferman, Michelle R; Adams, Amanda C; Platts-Mills, Timothy F

    2017-10-11

    To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status. Cross-sectional analysis. Random sample of interventional phase 2-4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov. For each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the trial had actually been completed. For each trial listed as completed or terminated early by ClinicalTrials.gov, we compared the date that the trial was actually concluded with the date the registry was updated to reflect the study's conclusion status. Among the 405 included trials, 92 had a registry status indicating that study activity was either ongoing or the recruitment status was unknown. Of these, published results were available for 34 (37%). Among the 313 concluded trials, the median delay between study completion and a registry update reflecting that the study had ended was 141 days (IQR 48-419), with delays of over 1 year present for 29%. In total, 125 trials (31%) either had a listed recruitment status which was incorrect or had a delay of more than 1 year between the time the study was concluded and the time the registry recruitment status was updated. At present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong. This inaccuracy has implications for the ability of researchers to identify completed trials and accurately characterise all available medical knowledge on a given subject. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Lifestyle intervention in general practice for physical activity, smoking, alcohol consumption and diet in elderly: a randomized controlled trial.

    PubMed

    Vrdoljak, Davorka; Marković, Biserka Bergman; Puljak, Livia; Lalić, Dragica Ivezić; Kranjčević, Ksenija; Vučak, Jasna

    2014-01-01

    The purpose of the study was to compare the effectiveness of programmed and intensified intervention on lifestyle changes, including physical activity, cigarette smoking, alcohol consumption and diet, in patients aged ≥ 65 with the usual care of general practitioners (GP). In this multicenter randomized controlled trial, 738 patients aged ≥ 65 were randomly assigned to receive intensified intervention (N = 371) or usual care (N = 367) of a GP for lifestyle changes, with 18-month follow-up. The main outcome measures were physical activity, smoking, alcohol consumption and diet. The study was conducted in 59 general practices in Croatia between May 2008 and May 2010. The patients' mean age was 72.3 ± 5.2 years. Significant diet correction was achieved after 18-month follow-up in the intervention group, comparing to controls. More patients followed strictly Mediterranean diet and consumed healthy foods more frequently. There was no significant difference between the groups in physical activity, tobacco smoking and alcohol consumption or diet after the intervention. In conclusion, an 18-month intensified GP's intervention had limited effect on lifestyle habits. GP intervention managed to change dietary habits in elderly population, which is encouraging since elderly population is very resistant regarding lifestyle habit changes. Clinical trial registration number. ISRCTN31857696. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  13. A pragmatic examination of active and passive recruitment methods to improve the reach of community lifestyle programs: The Talking Health Trial.

    PubMed

    Estabrooks, Paul; You, Wen; Hedrick, Valisa; Reinholt, Margaret; Dohm, Erin; Zoellner, Jamie

    2017-01-19

    A primary challenge for behavior change strategies is ensuring that interventions can be effective while also attracting a broad and representative sample of the target population. The purpose of this case-study was to report on (1) the reach of a randomized controlled trial targeting reduced sugary beverages, (2) potential participant characteristic differences based on active versus passive recruitment strategies, and (3) recruitment strategy cost. Demographic and recruitment information was obtained for 8 counties and for individuals screened for participation. Personnel activities and time were tracked. Costs were calculated and compared by active versus passive recruitment. Six-hundred and twenty, of 1,056 screened, individuals were eligible and 301enrolled (77% women; 90% white; mean income $21,981 ± 16,443). Eighty-two and 44% of those responding to passive and active methods, respectively, enrolled in the trial. However, active recruitment strategies yielded considerably more enrolled (active = 199; passive = 102) individuals. Passive recruitment strategies yielded a less representative sample in terms of gender (more women), education (higher), and income (higher; p's <0.05). The average cost of an actively recruited and enrolled participant was $278 compared to $117 for a passively recruited and enrolled participant. Though passive recruitment is more cost efficient it may reduce the reach of sugary drink reduction strategies in lower educated and economic residents in rural communities. Clinicaltrials.gov; ID: NCT02193009 , July 2014, retrospectively registered.

  14. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

    PubMed Central

    2011-01-01

    Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

  15. Effects of active video games on body composition: a randomized controlled trial.

    PubMed

    Maddison, Ralph; Foley, Louise; Ni Mhurchu, Cliona; Jiang, Yannan; Jull, Andrew; Prapavessis, Harry; Hohepa, Maea; Rodgers, Anthony

    2011-07-01

    Sedentary activities such as video gaming are independently associated with obesity. Active video games, in which players physically interact with images on screen, may help increase physical activity and improve body composition. The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight, body composition, physical activity, and physical fitness. We conducted a 2-arm, parallel, randomized controlled trial in Auckland, New Zealand. A total of 322 overweight and obese children aged 10-14 y, who were current users of sedentary video games, were randomly assigned at a 1:1 ratio to receive either an active video game upgrade package (intervention, n = 160) or to have no change (control group, n = 162). The primary outcome was the change from baseline in body mass index (BMI; in kg/m(2)). Secondary outcomes were changes in percentage body fat, physical activity, cardiorespiratory fitness, video game play, and food snacking. At 24 wk, the treatment effect on BMI (-0.24; 95% CI: -0.44, -0.05; P = 0.02) favored the intervention group. The change (±SE) in BMI from baseline increased in the control group (0.34 ± 0.08) but remained the same in the intervention group (0.09 ± 0.08). There was also evidence of a reduction in body fat in the intervention group (-0.83%; 95% CI: -1.54%, -0.12%; P = 0.02). The change in daily time spent playing active video games at 24 wk increased (10.03 min; 95% CI: 6.26, 13.81 min; P < 0.0001) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games (-9.39 min; 95% CI: -19.38, 0.59 min; P = 0.06). An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children. This trial was registered in the Australian New Zealand Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493.

  16. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt.

    PubMed

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-11-11

    Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness. Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)). 460 participants (46.6% female; 13.2 (0.4) years old). 8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition. Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline. All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive 'fun'; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1.8 (0.1 to 3.4) p=0.04 but no difference in shyness/sociability. Participation in activity types

  17. Putting brain training to the test in the workplace: a randomized, blinded, multisite, active-controlled trial.

    PubMed

    Borness, Catherine; Proudfoot, Judith; Crawford, John; Valenzuela, Michael

    2013-01-01

    Cognitive training (CT) is effective at improving cognitive outcomes in children with and without clinical impairment as well as older individuals. Yet whether CT is of any preventative health benefit to working age adults is controversial. Our objective was therefore to investigate the real-world efficacy of CT in the workplace, involving employees from across the working-age spectrum and addressing many of the design issues that have limited trials to date. 135 white collar employees of a large Australian public sector organization were randomised to either 16 weeks (20 minutes three times per week) of online CT or an active control (AC) program of equal length and structure. Cognitive, wellbeing and productivity outcome measures were analysed across three timepoints: baseline, immediately after training and 6 months post-training. CT effects on cognitive outcomes were limited, even after planned subgroup analyses of cognitive capacity and age. Unexpectedly, we found that our AC condition, which comprised viewing short documentaries about the natural world, had more impact. Compared to the CT group, 6 months after the end of training, those in the AC group experienced a significant increase in their self-reported Quality of Life (Effect Size g = .34 vs -.15; TIME×GROUP p = .003), decrease in stress levels (g = .22 vs -.19; TIME x GROUP p = .03), and overall improvement in Psychological Wellbeing (g = .32 vs -.06; TIME×GROUP p = .02). CT does not appear to positively impact cognition or wellbeing amongst white collar office workers; however, short time-out respite activities may have value in the promotion of psychological wellbeing. Given looming challenges to workplace productivity, further work-based interventional research targeting employee mental health is recommended. THIS TRIAL WAS REGISTERED WITH THE AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12610000604000 (http://www.anzctr.org.au/TrialSearch.aspx).

  18. Influenza detection and prediction algorithms: comparative accuracy trial in Östergötland county, Sweden, 2008-2012.

    PubMed

    Spreco, A; Eriksson, O; Dahlström, Ö; Timpka, T

    2017-07-01

    Methods for the detection of influenza epidemics and prediction of their progress have seldom been comparatively evaluated using prospective designs. This study aimed to perform a prospective comparative trial of algorithms for the detection and prediction of increased local influenza activity. Data on clinical influenza diagnoses recorded by physicians and syndromic data from a telenursing service were used. Five detection and three prediction algorithms previously evaluated in public health settings were calibrated and then evaluated over 3 years. When applied on diagnostic data, only detection using the Serfling regression method and prediction using the non-adaptive log-linear regression method showed acceptable performances during winter influenza seasons. For the syndromic data, none of the detection algorithms displayed a satisfactory performance, while non-adaptive log-linear regression was the best performing prediction method. We conclude that evidence was found for that available algorithms for influenza detection and prediction display satisfactory performance when applied on local diagnostic data during winter influenza seasons. When applied on local syndromic data, the evaluated algorithms did not display consistent performance. Further evaluations and research on combination of methods of these types in public health information infrastructures for 'nowcasting' (integrated detection and prediction) of influenza activity are warranted.

  19. Effects of physical activity on schoolchildren's academic performance: The Active Smarter Kids (ASK) cluster-randomized controlled trial.

    PubMed

    Resaland, Geir K; Aadland, Eivind; Moe, Vegard Fusche; Aadland, Katrine N; Skrede, Turid; Stavnsbo, Mette; Suominen, Laura; Steene-Johannessen, Jostein; Glosvik, Øyvind; Andersen, John R; Kvalheim, Olav M; Engelsrud, Gunn; Andersen, Lars B; Holme, Ingar M; Ommundsen, Yngvar; Kriemler, Susi; van Mechelen, Willem; McKay, Heather A; Ekelund, Ulf; Anderssen, Sigmund A

    2016-10-01

    To investigate the effect of a seven-month, school-based cluster-randomized controlled trial on academic performance in 10-year-old children. In total, 1129 fifth-grade children from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention group or to the control group. The children in the 28 intervention schools participated in a physical activity intervention between November 2014 and June 2015 consisting of three components: 1) 90min/week of physically active educational lessons mainly carried out in the school playground; 2) 5min/day of physical activity breaks during classroom lessons; 3) 10min/day physical activity homework. Academic performance in numeracy, reading and English was measured using standardized Norwegian national tests. Physical activity was measured objectively by accelerometry. We found no effect of the intervention on academic performance in primary analyses (standardized difference 0.01-0.06, p>0.358). Subgroup analyses, however, revealed a favorable intervention effect for those who performed the poorest at baseline (lowest tertile) for numeracy (p=0.005 for the subgroup∗group interaction), compared to controls (standardized difference 0.62, 95% CI 0.19-1.07). This large, rigorously conducted cluster RCT in 10-year-old children supports the notion that there is still inadequate evidence to conclude that increased physical activity in school enhances academic achievement in all children. Still, combining physical activity and learning seems a viable model to stimulate learning in those academically weakest schoolchildren. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial

    PubMed Central

    Smith, Ashleigh E; Davison, Kade

    2017-01-01

    Background Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity–related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. Objective The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). Methods This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant’s home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will

  1. "Active Team" a social and gamified app-based physical activity intervention: randomised controlled trial study protocol.

    PubMed

    Edney, Sarah; Plotnikoff, Ronald; Vandelanotte, Corneel; Olds, Tim; De Bourdeaudhuij, Ilse; Ryan, Jillian; Maher, Carol

    2017-11-02

    Physical inactivity is a leading preventable cause of chronic disease and premature death globally, yet over half of the adult Australian population is inactive. To address this, web-based physical activity interventions, which have the potential to reach large numbers of users at low costs, have received considerable attention. To fully realise the potential of such interventions, there is a need to further increase their appeal to boost engagement and retention, and sustain intervention effects over longer periods of time. This randomised controlled trial aims to evaluate the efficacy of a gamified physical activity intervention that connects users to each other via Facebook and is delivered via a mobile app. The study is a three-group, cluster-RCT. Four hundred and forty (440) inactive Australian adults who use Facebook at least weekly will be recruited in clusters of three to eight existing Facebook friends. Participant clusters will be randomly allocated to one of three conditions: (1) waitlist control condition, (2) basic experimental condition (pedometer plus basic app with no social and gamification features), or (3) socially-enhanced experimental condition (pedometer plus app with social and gamification features). Participants will undertake assessments at baseline, three and nine months. The primary outcome is change in total daily minutes of moderate-to-vigorous physical activity at three months measured objectively using GENEActive accelerometers [Activeinsights Ltd., UK]. Secondary outcomes include self-reported physical activity, depression and anxiety, wellbeing, quality of life, social-cognitive theory constructs and app usage and engagement. The current study will incorporate novel social and gamification elements in order to examine whether the inclusion of these components increases the efficacy of app-based physical activity interventions. The findings will be used to guide the development and increase the effectiveness of future health

  2. The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend) Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity.

    PubMed

    Campbell, Karen J; Hesketh, Kylie D; McNaughton, Sarah A; Ball, Kylie; McCallum, Zoë; Lynch, John; Crawford, David A

    2016-02-18

    Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. The Infant Feeding Activity and Nutrition Trial (InFANT) Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month) and enhanced (use of web-based materials, and Facebook® engagement), version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. ACTRN12611000386932. Registered 13 April 2011.

  3. The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols

    PubMed Central

    2011-01-01

    Background Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke. Methods/Design This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians. Discussion The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033 PMID:21767413

  4. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial.

    PubMed

    Tarp, Jakob; Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12-14 years old adolescents. A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p's>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4-38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39-0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0-9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p's>0.05). No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a

  5. Gamified physical activation of young men – a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study)

    PubMed Central

    2013-01-01

    Background Inactive and unhealthy lifestyles are common among adolescent men. The planned intervention examines the effectiveness of an interactive, gamified activation method, based on tailored health information, peer networks and participation, on physical activity, health and wellbeing in young men. We hypothesize that following the intervention the physical activation group will have an improved physical activity, as well as self-determined and measured health compared with the controls. Methods/design Conscription-aged men (18 years) attending compulsory annual call-ups for military service in the city of Oulu in Finland (n = 1500) will be randomized to a 6-months intervention (n = 640) or a control group (n = 640) during the fall 2013. A questionnaire on health, health behaviour, diet and wellbeing is administered in the beginning and end of the intervention. In addition, anthropometric measures (height, weight and waist circumference), body composition, grip strength, heart rate variability and aerobic fitness will be measured. The activation group utilizes an online gamified activation method in combination with communal youth services, objective physical activity measurement, social networking, tailored health information and exercise programs according to baseline activity level and the readiness of changes of each individual. Daily physical activity of the participants is monitored in both the activation and control groups. The activation service rewards improvements in physical activity or reductions in sedentary behaviour. The performance and completion of the military service of the participants will also be followed. Discussion The study will provide new information of physical activity, health and health behaviour of young men. Furthermore, a novel model including methods for increasing physical activity among young people is developed and its effects tested through an intervention. This unique gamified service for activating young men

  6. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial.

    PubMed

    Rovniak, Liza S; Kong, Lan; Hovell, Melbourne F; Ding, Ding; Sallis, James F; Ray, Chester A; Kraschnewski, Jennifer L; Matthews, Stephen A; Kiser, Elizabeth; Chinchilli, Vernon M; George, Daniel R; Sciamanna, Christopher N

    2016-12-01

    Social networks can influence physical activity, but little is known about how best to engineer online and in-person social networks to increase activity. The purpose of this study was to conduct a randomized trial based on the Social Networks for Activity Promotion model to assess the incremental contributions of different procedures for building social networks on objectively measured outcomes. Physically inactive adults (n = 308, age, 50.3 (SD = 8.3) years, 38.3 % male, 83.4 % overweight/obese) were randomized to one of three groups. The Promotion group evaluated the effects of weekly emailed tips emphasizing social network interactions for walking (e.g., encouragement, informational support); the Activity group evaluated the incremental effect of adding an evidence-based online fitness walking intervention to the weekly tips; and the Social Networks group evaluated the additional incremental effect of providing access to an online networking site for walking as well as prompting walking/activity across diverse settings. The primary outcome was mean change in accelerometer-measured moderate-to-vigorous physical activity (MVPA), assessed at 3 and 9 months from baseline. Participants increased their MVPA by 21.0 min/week, 95 % CI [5.9, 36.1], p = .005, at 3 months, and this change was sustained at 9 months, with no between-group differences. Although the structure of procedures for targeting social networks varied across intervention groups, the functional effect of these procedures on physical activity was similar. Future research should evaluate if more powerful reinforcers improve the effects of social network interventions. The trial was registered with the ClinicalTrials.gov (NCT01142804).

  7. Randomized Controlled Trial to Increase Physical Activity among Insufficiently Active Women Following Their Participation in a Mass Event

    ERIC Educational Resources Information Center

    Lane, Aoife; Murphy, Niamh; Bauman, Adrian; Chey, Tien

    2010-01-01

    Objective: To assess the impact of a community based, low-contact intervention on the physical activity habits of insufficiently active women. Design: Randomized controlled trial. Participants: Inactive Irish women. Method: A population sample of women participating in a mass 10 km event were up followed at 2 and 6 months, and those who had…

  8. Effectiveness of a Web 2.0 Intervention to Increase Physical Activity in Real-World Settings: Randomized Ecological Trial

    PubMed Central

    Kolt, Gregory S; Caperchione, Cristina M; Savage, Trevor N; Rosenkranz, Richard R; Maeder, Anthony J; Van Itallie, Anetta; Tague, Rhys; Oldmeadow, Christopher; Mummery, W Kerry; Duncan, Mitch J

    2017-01-01

    Background The translation of Web-based physical activity intervention research into the real world is lacking and becoming increasingly important. Objective To compare usage and effectiveness, in real-world settings, of a traditional Web 1.0 Web-based physical activity intervention, providing limited interactivity, to a Web 2.0 Web-based physical activity intervention that includes interactive features, such as social networking (ie, status updates, online “friends,” and personalized profile pages), blogs, and Google Maps mash-ups. Methods Adults spontaneously signing up for the freely available 10,000 Steps website were randomized to the 10,000 Steps website (Web 1.0) or the newly developed WALK 2.0 website (Web 2.0). Physical activity (Active Australia Survey), quality of life (RAND 36), and body mass index (BMI) were assessed at baseline, 3 months, and 12 months. Website usage was measured continuously. Analyses of covariance were used to assess change over time in continuous outcome measures. Multiple imputation was used to deal with missing data. Results A total of 1328 participants completed baseline assessments. Only 3-month outcomes (224 completers) were analyzed due to high attrition at 12 months (77 completers). Web 2.0 group participants increased physical activity by 92.8 minutes per week more than those in the Web 1.0 group (95% CI 28.8-156.8; P=.005); their BMI values also decreased more (–1.03 kg/m2, 95% CI –1.65 to -0.41; P=.001). For quality of life, only the physical functioning domain score significantly improved more in the Web 2.0 group (3.6, 95% CI 1.7-5.5; P<.001). The time between the first and last visit to the website (3.57 vs 2.22 weeks; P<.001) and the mean number of days the website was visited (9.02 vs 5.71 days; P=.002) were significantly greater in the Web 2.0 group compared to the Web 1.0 group. The difference in time-to-nonusage attrition was not statistically significant between groups (Hazard Ratio=0.97, 95% CI 0

  9. Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial.

    PubMed

    Morgan, Gemma S; Haase, Anne M; Campbell, Rona; Ben-Shlomo, Yoav

    2015-03-13

    As people live longer, their risk of disability increases. Disability affects quality of life and increases health and social care costs. Preventing or delaying disability is therefore an important objective, and identifying an effective intervention could improve the lives of many older people. Observational and interventional evidence suggests that physical activity may reduce the risk of age-related disability, as assessed by physical performance measures. However it is unclear what approach is the most cost-effective intervention in changing long-term physical activity behaviour in older adults. A new theory-driven behavioural intervention has been developed, with the aim of increasing physical activity in the everyday lives of older adults at risk of disability. This pilot study tests the feasibility and acceptability of delivering this intervention to older adults. A randomised controlled trial (RCT) design will be used in the pilot study. Sixty patients aged 65 years and older will be recruited from primary care practices. Patients will be eligible to participate if they are inactive, not disabled at baseline, are at risk of developing disability in the future (Short Physical Performance Battery score <10/12), and have no contraindications to physical activity. Following baseline measures, participants will be randomised in a 2:1 ratio to the intervention or to a control arm and all participants will be followed-up after 6 months. Those randomised to the intervention arm will receive sessions with a trained Physical Activity Facilitator, delivering an intervention based on self-determination theory. Control participants receive a booklet on healthy ageing. The main outcomes of interest are recruitment, adherence, retention and acceptability. Data will also be collected on: self-report and accelerometer-recorded physical activity; physical performance; depression; wellbeing; cognitive function; social support; quality of life, healthcare use, and attitudes to

  10. Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

    PubMed

    Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

    2017-11-01

    This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

  11. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial.

    PubMed

    Wang, Chenchen; Schmid, Christopher H; Iversen, Maura D; Harvey, William F; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Wong, John B; Reid, Kieran F; Rones, Ramel; McAlindon, Timothy

    2016-07-19

    Few remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis. To compare Tai Chi with standard physical therapy for patients with knee osteoarthritis. Randomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985). An urban tertiary care academic hospital. 204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white). Tai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise). The primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life. At 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred. Patients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined. Tai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis. National Center for Complementary and Integrative Health of the National Institutes of Health.

  12. Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

    PubMed

    Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

    2009-07-01

    The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

  13. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  14. Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials.

    PubMed

    Koopmeiners, Joseph S; Hobbs, Brian P

    2018-05-01

    Randomized, placebo-controlled clinical trials are the gold standard for evaluating a novel therapeutic agent. In some instances, it may not be considered ethical or desirable to complete a placebo-controlled clinical trial and, instead, the placebo is replaced by an active comparator with the objective of showing either superiority or non-inferiority to the active comparator. In a non-inferiority trial, the experimental treatment is considered non-inferior if it retains a pre-specified proportion of the effect of the active comparator as represented by the non-inferiority margin. A key assumption required for valid inference in the non-inferiority setting is the constancy assumption, which requires that the effect of the active comparator in the non-inferiority trial is consistent with the effect that was observed in previous trials. It has been shown that violations of the constancy assumption can result in a dramatic increase in the rate of incorrectly concluding non-inferiority in the presence of ineffective or even harmful treatment. In this paper, we illustrate how Bayesian hierarchical modeling can be used to facilitate multi-source smoothing of the data from the current trial with the data from historical studies, enabling direct probabilistic evaluation of the constancy assumption. We then show how this result can be used to adapt the non-inferiority margin when the constancy assumption is violated and present simulation results illustrating that our method controls the type-I error rate when the constancy assumption is violated, while retaining the power of the standard approach when the constancy assumption holds. We illustrate our adaptive procedure using a non-inferiority trial of raltegravir, an antiretroviral drug for the treatment of HIV.

  15. Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

    PubMed

    Demaerschalk, Bart M; Brown, Robert D; Roubin, Gary S; Howard, Virginia J; Cesko, Eldina; Barrett, Kevin M; Longbottom, Mary E; Voeks, Jenifer H; Chaturvedi, Seemant; Brott, Thomas G; Lal, Brajesh K; Meschia, James F; Howard, George

    2017-09-01

    Multicenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection. In the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type. For 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites. Overall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217. © 2017

  16. Effects of Hydroxychloroquine on Immune Activation and Disease Progression Among HIV-Infected Patients Not Receiving Antiretroviral Therapy A Randomized Controlled Trial

    PubMed Central

    Paton, Nicholas I.; Goodall, Ruth L.; Dunn, David T.; Franzen, Samuel; Collaco-Moraes, Yolanda; Gazzard, Brian G.; Williams, Ian G.; Fisher, Martin J.; Winston, Alan; Fox, Julie; Orkin, Chloe; Herieka, Elbushra A.; Ainsworth, Jonathan G.; Post, Frank A.; Wansbrough-Jones, Mark; Kelleher, Peter

    2013-01-01

    Context Therapies to decrease immune activation might be of benefit in slowing HIV disease progression. Objective To determine whether hydroxychloroquine decreases immune activation and slows CD4 cell decline. Design, Setting, and Patients Randomized, double-blind, placebo-controlled trial performed at 10 HIV outpatient clinics in the United Kingdom between June 2008 and February 2011. The 83 patients enrolled had asymptomatic HIV infection, were not taking antiretroviral therapy, and had CD4 cell counts greater than 400 cells/μL. Intervention Hydroxychloroquine, 400 mg, or matching placebo once daily for 48 weeks. Main Outcome Measures The primary outcome measure was change in the proportion of activated CD8 cells (measured by the expression of CD38 and HLA-DR surface markers), with CD4 cell count and HIV viral load as secondary outcomes. Analysis was by intention to treat using mixed linear models. Results There was no significant difference in CD8 cell activation between the 2 groups (−4.8% and −4.2% in the hydroxychloroquine and placebo groups, respectively, at week 48; difference, −0.6%; 95% CI, −4.8% to 3.6%; P=.80). Decline in CD4 cell count was greater in the hydroxychloroquine than placebo group (−85 cells/μL vs −23 cells/μL at week 48; difference, −62 cells/μL; 95% CI, −115 to −8; P=.03). Viral load increased in the hydroxychloroquine group compared with placebo (0.61 log10 copies/mL vs 0.23 log10 copies/mL at week 48; difference, 0.38 log10 copies/mL; 95% CI, 0.13 to 0.63; P=.003). Antiretroviral therapy was started in 9 patients in the hydroxychloroquine group and 1 in the placebo group. Trial medication was well tolerated, but more patients reported influenza-like illness in the hydroxychloroquine group compared with the placebo group (29% vs 10%; P=.03). Conclusion Among HIV-infected patients not taking antiretroviral therapy, the use of hydroxychloroquine compared with placebo did not reduce CD8 cell activation but did result in

  17. Meta-analysis of randomized controlled trials comparing 17α-hydroxyprogesterone caproate and vaginal progesterone for the prevention of recurrent spontaneous preterm delivery.

    PubMed

    Oler, Elizabeth; Eke, Ahizechukwu C; Hesson, Ashley

    2017-07-01

    Vaginal progesterone and 17α-hydroxyprogesterone (17α-OHP) are both used to prevent preterm delivery in women who have experienced spontaneous preterm delivery (SPTD) previously. Randomized trial data of the comparative effectiveness of these interventions have been mixed. To compare the efficacy of intramuscular 17α-OHP and vaginal progesterone in the prevention of recurrent SPTD. Cochrane Central Register of Controlled Trials, African Journals Online, Embase, Google Scholar, ISI Web of Science, LILACS, CINAHL, PubMed, and registers of ongoing trials were searched using keywords related to 17α-OHP, vaginal progesterone, and preterm delivery. Randomized controlled trials published between January 1, 1966, and November 30, 2016, comparing 17α-OHP and vaginal progesterone for the prevention of recurrent SPTD during singleton pregnancies were included. Study data were extracted and meta-analyses were performed when outcomes were comparable. The meta-analyses included data from three randomized trials. Lower rates of SPTD before 34 weeks (relative risk 0.71, 95% confidence interval 0.53-0.95) and before 32 weeks (relative risk 0.62, 95% confidence interval 0.40-0.94) of pregnancy were observed among patients treated with vaginal progesterone. Vaginal progesterone and 17α-OHP were comparable for the prevention of recurrent SPTD in singleton pregnancies; vaginal progesterone could be superior. © 2017 International Federation of Gynecology and Obstetrics.

  18. Sweat Chloride as A Biomarker of CFTR Activity: Proof of Concept and Ivacaftor Clinical Trial Data

    PubMed Central

    Accurso, Frank J.; Van Goor, Fredrick; Zha, Jiuhong; Stone, Anne J.; Dong, Qunming; Ordonez, Claudia L.; Rowe, Steven M.; Clancy, John Paul; Konstan, Michael W.; Hoch, Heather E.; Heltshe, Sonya L.; Ramsey, Bonnie W.; Campbell, Preston W.; Ashlock, Melissa A.

    2014-01-01

    Background We examined data from a Phase 2 trial {NCT00457821 } of ivacaftor, a CFTR potentiator, in cystic fibrosis (CF) patients with a G551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference (NPD) to estimate CFTR activity. Methods Sweat chloride and NPD were secondary endpoints in this placebo-controlled, multicenter trial. Standardization of sweat collection, processing, and analysis was employed for the first time.. Sweat chloride and chloride ion transport (NPD) were integrated into a model of CFTR activity. Results Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects. Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40% of normal. Conclusions Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators. PMID:24660233

  19. Sweat chloride as a biomarker of CFTR activity: proof of concept and ivacaftor clinical trial data.

    PubMed

    Accurso, Frank J; Van Goor, Fredrick; Zha, Jiuhong; Stone, Anne J; Dong, Qunming; Ordonez, Claudia L; Rowe, Steven M; Clancy, John Paul; Konstan, Michael W; Hoch, Heather E; Heltshe, Sonya L; Ramsey, Bonnie W; Campbell, Preston W; Ashlock, Melissa A

    2014-03-01

    We examined data from a Phase 2 trial {NCT00457821} of ivacaftor, a CFTR potentiator, in cystic fibrosis (CF) patients with aG551D mutation to evaluate standardized approaches to sweat chloride measurement and to explore the use of sweat chloride and nasal potential difference (NPD) to estimate CFTR activity. Sweat chloride and NPD were secondary endpoints in this placebo-controlled, multicenter trial. Standardization of sweat collection, processing,and analysis was employed for the first time. Sweat chloride and chloride ion transport (NPD) were integrated into a model of CFTR activity. Within-patient sweat chloride determinations showed sufficient precision to detect differences between dose-groups and assess ivacaftor treatment effects. Analysis of changes in sweat chloride and NPD demonstrated that patients treated with ivacaftor achieved CFTR activity equivalent to approximately 35%–40% of normal. Sweat chloride is useful in multicenter trials as a biomarker of CFTR activity and to test the effect of CFTR potentiators.

  20. Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

    PubMed

    Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

    2010-01-01

    To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

  1. Comparing exercise interventions to increase persistence with physical exercise and sporting activity among people with hypertension or high normal blood pressure: study protocol for a randomised controlled trial.

    PubMed

    Fife-Schaw, Chris; de Lusignan, Simon; Wainwright, Joe; Sprake, Hannah; Laver, Suzannah; Heald, Victoria; Orton, Julian; Prescott, Matt; Carr, Helen; O'Neill, Mark

    2014-08-28

    Increasing physical activity is known to have health benefits for people with hypertension and related conditions. Current general practitioner referrals for gym-based exercise increase physical activity but meta-analyses show that while these are effective the absolute health risk reduction is small due to patients failing to maintain activity levels over time. This study assesses the effectiveness of two sports-oriented interventions that are intended to bridge the intention-behaviour gap and thus increase the likelihood of sustained increases in physical activity. Four-arm randomised controlled trial. The study tests two types of intervention that are intended to increase physical activity among currently inactive 18- to 74-year-old people with hypertension or high-normal blood pressure. This study will assess the effectiveness of a 12-week sports-oriented exercise programme, the efficacy of a web-delivered self-help tool to promote and support sports participation and healthy behaviour change and the effect of these interventions in combination. The control arm will be a standard care general practitioner referral for gym-based exercise. Participants will be allocated using block randomisation. The first author and primary analyst is blinded to participant allocation. The primary outcome measures will be time spent in physical activity assessed in metabolic equivalent minutes per week using the International Physical Activity Questionnaire 1 year after commencement of the intervention. Secondary outcomes include increased involvement in sporting activity and biomedical health outcomes including change in body mass index, and waist and hip measurement and reductions in blood pressure. If proven to be superior to general practitioner referrals for gym-based exercise, these sports-oriented interventions would constitute low-cost alternatives. The next stage would be a full economic evaluation of the interventions. Current Controlled Trials ISRCTN71952900 (7 June

  2. Comparative effectiveness from a single-arm trial and real-world data: alectinib versus ceritinib.

    PubMed

    Davies, Jessica; Martinec, Michael; Delmar, Paul; Coudert, Mathieu; Bordogna, Walter; Golding, Sophie; Martina, Reynaldo; Crane, Gracy

    2018-06-26

    To compare the overall survival of anaplastic lymphoma kinase-positive non-small-cell lung cancer patients who received alectinib with those who received ceritinib. Two treatment arms (alectinib [n = 183] and ceritinib [n = 67]) were extracted from clinical trials and an electronic health record database, respectively. Propensity scores were applied to balance baseline characteristics. Kaplan-Meier and multivariate Cox regression were conducted. After propensity score adjustment, baseline characteristics were balanced. Alectinib had a prolonged median overall survival (alectinib = 24.3 months and ceritinib = 15.6 months) and lower risk of death (hazard ratio: 0.65; 95% CI: 0.48-0.88). Alectinib was associated with prolonged overall survival versus ceritinib, which is consistent with efficacy evidence from clinical trials.

  3. Left ventricular ejection fraction may not be useful as an end point of thrombolytic therapy comparative trials.

    PubMed

    Califf, R M; Harrelson-Woodlief, L; Topol, E J

    1990-11-01

    In the era of comparative and adjunctive trials in reperfusion therapy, the need to develop alternative end points for mortality reduction is clear. Left ventricular ejection fraction, which has been commonly used as a surrogate, is problematic due to missing values, technically inadequate studies, and lack of correlation with mortality results in controlled reperfusion trials performed to date. In this paper, we present a composite clinical end point that includes, in order, severity of adverse outcome death, hemorrhagic stroke, nonhemorrhagic stroke, poor ejection fraction (less than 30%), reinfarction, heart failure, and pulmonary edema. Such a composite index may be useful to detect true therapeutic benefit in reperfusion trials without necessitating greater than 20-30,000 patient enrollment.

  4. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial.

    PubMed

    Collado, Anahi; Long, Katherine E; MacPherson, Laura; Lejuez, Carl W

    2014-06-18

    examine the effect of the proposed mechanisms of change of behavioral activation treatment for depression (that is, activity level and environmental reward) on depression over time. To our knowledge, this is the first randomized controlled trial to compare an empirical-supported treatment to a control supportive counseling condition in a sample of depressed, Spanish-speaking Latinos in the United States. Clinical Trials Register: NCT01958840; registered 8 October 2013.

  5. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov.

    PubMed

    Bell, Stuart A; Tudur Smith, Catrin

    2014-11-26

    To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Registry based study of ClinicalTrials.gov registration entries. The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,088 Interventional trials registered after January 1, 2006, conducted in the United States, Canada and/or the European Union were categorised as rare or non-rare. Characteristics of the respective trials were extracted and summarised with comparative statistics calculated where appropriate. Characteristics of interventional trials reported in the database categorised by rare and non-rare conditions to allow comparison. Of the 24,088 trials categorised 2,759 (11.5%) were classified as rare disease trials and 21,329 (88.5%) related to non-rare conditions. Despite the limitations of the database we found that rare disease trials differed to non-rare disease trials across all characteristics that we examined. Rare disease trials enrolled fewer participants (median 29 vs. 62), were more likely to be single arm (63.0% vs. 29.6%), non-randomised (64.5% vs. 36.1%) and open label (78.7% vs. 52.2%). A higher proportion of rare disease trials were terminated early (13.7% vs. 6.3%) and proportionally fewer rare disease studies were actively pursuing, or waiting to commence, enrolment (15.9% vs. 38.5%). Rare disease interventional trials differ from those in non-rare conditions with notable differences in enrolment, design, blinding and randomisation. However, clinical trials should aim to implement the highest trial design standards possible, regardless of whether diseases are rare or not.

  6. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

    PubMed

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-12-01

    Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  7. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    PubMed Central

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-01-01

    Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

  8. A randomized controlled trial of an activity specific exercise program for individuals with Alzheimer disease in long-term care settings.

    PubMed

    Roach, Kathryn E; Tappen, Ruth M; Kirk-Sanchez, Neva; Williams, Christine L; Loewenstein, David

    2011-01-01

    To determine whether an activity specific exercise program could improve ability to perform basic mobility activities in long-term care residents with Alzheimer disease (AD). Randomized, controlled, single-blinded clinical trial. Residents of 7 long-term care facilities. Eighty-two long-term care residents with mild to severe AD. An activity specific exercise program was compared to a walking program and to an attention control. Ability to perform bed mobility and transfers was assessed using the subscales of the Acute Care Index of Function; functional mobility was measured using the 6-Minute Walk test. Subjects receiving the activity specific exercise program improved in ability to perform transfers, whereas subjects in the other 2 groups declined.

  9. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

    PubMed Central

    2011-01-01

    Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (<45 versus ≥45 years), presence of atrial septal aneurysm (ASA yes or no) and number of embolic events before randomization (one versus more than one event). Primary endpoints are death, nonfatal stroke and peripheral embolism. Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011). Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA PMID:21356042

  10. A comparative trial of psychotherapy and pharmacotherapy for "pure" dysthymic patients.

    PubMed

    Markowitz, John C; Kocsis, James H; Bleiberg, Kathryn L; Christos, Paul J; Sacks, Michael

    2005-12-01

    Psychotherapy of "pure" dysthymic disorder remains understudied. This article reports outcomes of an acute randomized trial of 94 subjects treated for 16 weeks with either interpersonal psychotherapy (IPT), brief supportive psychotherapy (BSP), sertraline, or sertraline plus IPT. Recruited by clinical referral and advertising, subjects met DSM-IV criteria for early onset dysthymic disorder, with no episode of major depression in the prior six months. They were randomly assigned to one of four 16-week treatments, with options for crossover or continuation treatment. Results were analyzed from the intention-to-treat sample by ANCOVA, controlling for baseline depressive severity. Subjects improved in all conditions over time, with the cells including sertraline pharmacotherapy showing superiority over psychotherapy alone for response and remission. Response rates were 58% for sertraline alone, 57% for combined treatment, 35% for IPT, and 31% for BSP. The study was underpowered and may have employed too "active" a control condition. Follow-up data were unobtainable. In this acute trial for "pure" dysthymic disorder, sertraline with or without IPT showed advantages relative to IPT and BSP. Methodological difficulties may have limited differential outcome findings. This study bolsters a small but growing literature on the treatment of dysthymic disorder, suggesting that pharmacotherapy may acutely benefit patients more than psychotherapy.

  11. Physical activity monitoring in adolescents with juvenile fibromyalgia: findings from a clinical trial of cognitive-behavioral therapy.

    PubMed

    Kashikar-Zuck, Susmita; Flowers, Stacy R; Strotman, Daniel; Sil, Soumitri; Ting, Tracy V; Schikler, Kenneth N

    2013-03-01

    Juvenile fibromyalgia (JFM) is a chronic musculoskeletal pain condition that is associated with reduced physical function. Recent research has demonstrated that cognitive-behavioral therapy (CBT) is effective in improving daily functioning among adolescents with JFM. However, it is not known whether these improvements were accompanied by increased physical activity levels. Our objective was to analyze secondary data from a randomized clinical trial of CBT to examine whether CBT was associated with improvement in objectively measured physical activity and whether actigraphy indices corresponded with self-reported functioning among adolescents with JFM. Participants were 114 adolescents (ages 11-18 years) recruited from pediatric rheumatology clinics that met criteria for JFM and were enrolled in a clinical trial. Subjects were randomly (1:1) assigned to receive either CBT or fibromyalgia education (FE). Participants wore a hip-mounted accelerometer for 1 week as part of their baseline and posttreatment assessments. The final sample included 68 subjects (94% female, mean age 15.2 years) for whom complete actigraphy data were obtained. Actigraphy measures were not found to correspond with self-reported improvements in functioning. While self-reported functioning improved in the CBT condition compared to FE, no significant changes were seen in either group for activity counts, sedentary, moderate, or vigorous activity. The CBT group had significantly lower peak and light activity at posttreatment. Actigraphy monitoring provides a unique source of information about patient outcomes. CBT intervention was not associated with increased physical activity in adolescents with JFM, indicating that combining CBT with interventions to increase physical activity may enhance treatment effects. Copyright © 2013 by the American College of Rheumatology.

  12. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  13. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  14. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  15. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of conduct...

  16. Exercise, education, manual-therapy and taping compared to education for patellofemoral osteoarthritis: a blinded, randomised clinical trial.

    PubMed

    Crossley, K M; Vicenzino, B; Lentzos, J; Schache, A G; Pandy, M G; Ozturk, H; Hinman, R S

    2015-09-01

    Patellofemoral joint osteoarthritis (PFJ OA) contributes considerably to knee OA symptoms. This study aimed to determine the efficacy of a PFJ-targeted exercise, education manual-therapy and taping program compared to OA education alone, in participants with PFJ OA. A randomised, participant-blinded and assessor-blinded clinical trial was conducted in primary-care physiotherapy. 92 people aged ≥40 years with symptomatic and radiographic PFJ OA participated. Physiotherapists delivered the PFJ-targeted exercise, education, manual-therapy and taping program, or the OA-education (control condition) in eight sessions over 12 weeks. Primary outcomes at 3-month (primary) and 9-month follow-up: (1) patient-perceived global rating of change (2) pain visual analogue scale (VAS) (100 mm); and (3) activities of daily living (ADL) subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS). 81 people (88%) completed the 3-month follow-up and data analysed on an intention-to-treat basis. Between-group baseline similarity for participant characteristics was observed. The exercise, education, manual-therapy and taping program resulted in more people reporting much improvement (20/44) than the OA-education group (5/48) (number needed to treat 3 (95% confidence interval (CI) 2 to 5)) and greater pain reduction (mean difference: -15.2 mm, 95% CI -27.0 to -3.4). No significant effects on ADL were observed (5.8; 95% CI -0.6 to 12.1). At 9 months there were no significant effects for self-report of improvement, pain (-10.5 mm, 95% CI -22.7 to 1.8) or ADL (3.0, 95% CI -3.7 to 9.7). Exercise, education, manual-therapy and taping can be recommended to improve short-term patient rating of change and pain severity. However over 9-months, both options were equivalent. Australian New Zealand Clinical Trials Registry (ACTRN12608000288325): https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82878. Copyright © 2015 Osteoarthritis Research Society International. Published

  17. Effect of physical activity on frailty and associated negative outcomes: the LIFE randomized trial

    USDA-ARS?s Scientific Manuscript database

    Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large, long-term, randomized trials are lacking. Objective: To determine whether a long-term structured moderate-intensity physical activity (PA) p...

  18. How Accurate Is Your Activity Tracker? A Comparative Study of Step Counts in Low-Intensity Physical Activities

    PubMed Central

    2017-01-01

    Background As commercially available activity trackers are being utilized in clinical trials, the research community remains uncertain about reliability of the trackers, particularly in studies that involve walking aids and low-intensity activities. While these trackers have been tested for reliability during walking and running activities, there has been limited research on validating them during low-intensity activities and walking with assistive tools. Objective The aim of this study was to (1) determine the accuracy of 3 Fitbit devices (ie, Zip, One, and Flex) at different wearing positions (ie, pants pocket, chest, and wrist) during walking at 3 different speeds, 2.5, 5, and 8 km/h, performed by healthy adults on a treadmill; (2) determine the accuracy of the mentioned trackers worn at different sites during activities of daily living; and (3) examine whether intensity of physical activity (PA) impacts the choice of optimal wearing site of the tracker. Methods We recruited 15 healthy young adults to perform 6 PAs while wearing 3 Fitbit devices (ie, Zip, One, and Flex) on their chest, pants pocket, and wrist. The activities include walking at 2.5, 5, and 8 km/h, pushing a shopping cart, walking with aid of a walker, and eating while sitting. We compared the number of steps counted by each tracker with gold standard numbers. We performed multiple statistical analyses to compute descriptive statistics (ie, ANOVA test), intraclass correlation coefficient (ICC), mean absolute error rate, and correlation by comparing the tracker-recorded data with that of the gold standard. Results All the 3 trackers demonstrated good-to-excellent (ICC>0.75) correlation with the gold standard step counts during treadmill experiments. The correlation was poor (ICC<0.60), and the error rate was significantly higher in walker experiment compared to other activities. There was no significant difference between the trackers and the gold standard in the shopping cart experiment. The wrist

  19. Re-estimating sample size in cluster randomised trials with active recruitment within clusters.

    PubMed

    van Schie, S; Moerbeek, M

    2014-08-30

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster level and individual level variance should be known before the study starts, but this is often not the case. We suggest using an internal pilot study design to address this problem of unknown variances. A pilot can be useful to re-estimate the variances and re-calculate the sample size during the trial. Using simulated data, it is shown that an initially low or high power can be adjusted using an internal pilot with the type I error rate remaining within an acceptable range. The intracluster correlation coefficient can be re-estimated with more precision, which has a positive effect on the sample size. We conclude that an internal pilot study design may be used if active recruitment is feasible within a limited number of clusters. Copyright © 2014 John Wiley & Sons, Ltd.

  20. Comparative trial of sclerotherapy for hydroceles.

    PubMed

    Rencken, R K; Bornman, M S; Reif, S; Olivier, I

    1990-04-01

    We present a prospective single-blind trial of sclerotherapy for hydroceles with tetradecyl sulphate and rolitetracycline as sclerosants. Twenty-seven hydroceles were treated with tetradecyl sulphate and 28 with rolitetracycline. The median follow-up was 13 months. There were no statistically significant differences between the 2 drugs in respect of cure rate and complications. The overall cure rate for both drugs was 96%. Complications were rare and common to both drugs. Tetradecyl sulphate and rolitetracycline were found to be equally effective as sclerosants.

  1. Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

    PubMed

    Bruggeman-Everts, Fieke Z; Wolvers, Marije D J; van de Schoot, Rens; Vollenbroek-Hutten, Miriam M R; Van der Lee, Marije L

    2017-10-19

    Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to

  2. A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

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

    Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A.; Nikam, M.

    Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technicalmore » success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.« less

  3. Initial Open Trial of a Computerized Behavioral Activation Treatment for Depression

    ERIC Educational Resources Information Center

    Spates, C. Richard; Kalata, Alyssa H.; Ozeki, Satoshi; Stanton, Cory E.; Peters, Sofia

    2013-01-01

    This article presents preliminary findings from use of a novel computer program that implements an evidence-based psychological intervention to treat depression based on behavioral activation (BA) therapy. The program is titled “Building a Meaningful Life Through Behavioral Activation”. The findings derive from an open trial with moderate to…

  4. Effectiveness of Computer Tailoring Versus Peer Support Web-Based Interventions in Promoting Physical Activity Among Insufficiently Active Canadian Adults With Type 2 Diabetes: Protocol for a Randomized Controlled Trial

    PubMed Central

    Côté, José

    2016-01-01

    Background Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that less than half of people with type 2 diabetes in Canada are sufficiently active to meet the Canadian Diabetes Association's guidelines, effective programs targeting the adoption of regular physical activity are in demand for this population. Many researchers have argued that Web-based interventions targeting physical activity are a promising avenue for insufficiently active populations; however, it remains unclear if this type of intervention is effective among people with type 2 diabetes. Objective This research project aims to evaluate the effectiveness of two Web-based interventions targeting the adoption of regular aerobic physical activity among insufficiently active adult Canadian Francophones with type 2 diabetes. Methods A 3-arm, parallel randomized controlled trial with 2 experimental groups and 1 control group was conducted in the province of Quebec, Canada. A total of 234 participants were randomized at a 1:1:1 ratio to receive an 8-week, fully automated, computer-tailored, Web-based intervention (experimental group 1); an 8-week peer support (ie, Facebook group) Web-based intervention (experimental group 2); or no intervention (control group) during the study period. Results The primary outcome of this study is self-reported physical activity level (total min/week of moderate-intensity aerobic physical activity). Secondary outcomes are attitude, social influence, self-efficacy, type of motivation, and intention. All outcomes are assessed at baseline and 3 and 9 months after baseline with a self-reported questionnaire filled directly on the study websites. Conclusions By evaluating and comparing the effectiveness of 2 Web-based interventions characterized by different behavior change perspectives, findings of this study will contribute to advances in the field of physical

  5. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial.

    PubMed

    Motes, Michael A; Yezhuvath, Uma S; Aslan, Sina; Spence, Jeffrey S; Rypma, Bart; Chapman, Sandra B

    2018-02-01

    Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Active Choice and Financial Incentives to Increase Rates of Screening Colonoscopy-A Randomized Controlled Trial.

    PubMed

    Mehta, Shivan J; Feingold, Jordyn; Vandertuyn, Matthew; Niewood, Tess; Cox, Catherine; Doubeni, Chyke A; Volpp, Kevin G; Asch, David A

    2017-11-01

    Behavioral economic approaches could increase uptake for colorectal cancer screening. We performed a randomized controlled trial of 2245 employees to determine whether an email containing a phone number for scheduling (control), an email with the active choice to opt in or opt out (active choice), or the active choice email plus a $100 incentive (financial incentive) increased colonoscopy completion within 3 months. Higher proportions of participants in the financial incentive group underwent screening (3.7%) than in the control (1.6%) or active choice groups (1.5%) (P = .01 and P < .01). We found no difference in uptake of screening between the active choice and control groups (P = .88). The $100 conditional incentive modestly but significantly increased colonoscopy use. ClinicalTrials.gov no: NCT02660671. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

  7. Trial-to-trial adjustments of speed-accuracy trade-offs in premotor and primary motor cortex

    PubMed Central

    Guberman, Guido; Cisek, Paul

    2016-01-01

    Recent studies have shown that activity in sensorimotor structures varies depending on the speed-accuracy trade-off (SAT) context in which a decision is made. Here we tested the hypothesis that the same areas also reflect a more local adjustment of SAT established between individual trials, based on the outcome of the previous decision. Two monkeys performed a reaching decision task in which sensory evidence continuously evolves during the time course of a trial. In two SAT contexts, we compared neural activity in trials following a correct choice vs. those following an error. In dorsal premotor cortex (PMd), we found that 23% of cells exhibited significantly weaker baseline activity after error trials, and for ∼30% of these this effect persisted into the deliberation epoch. These cells also contributed to the process of combining sensory evidence with the growing urgency to commit to a choice. We also found that the activity of 22% of PMd cells was increased after error trials. These neurons appeared to carry less information about sensory evidence and time-dependent urgency. For most of these modulated cells, the effect was independent of whether the previous error was expected or unexpected. We found similar phenomena in primary motor cortex (M1), with 25% of cells decreasing and 34% increasing activity after error trials, but unlike PMd, these neurons showed less clear differences in their response properties. These findings suggest that PMd and M1 belong to a network of brain areas involved in SAT adjustments established using the recent history of reinforcement. NEW & NOTEWORTHY Setting the speed-accuracy trade-off (SAT) is crucial for efficient decision making. Previous studies have reported that subjects adjust their SAT after individual decisions, usually choosing more conservatively after errors, but the neural correlates of this phenomenon are only partially known. Here, we show that neurons in PMd and M1 of monkeys performing a reach decision task

  8. Motivational interviewing in a Web-based physical activity intervention with an avatar: randomized controlled trial.

    PubMed

    Friederichs, Stijn; Bolman, Catherine; Oenema, Anke; Guyaux, Janneke; Lechner, Lilian

    2014-02-13

    Developing Web-based physical activity (PA) interventions based on motivational interviewing (MI) could increase the availability and reach of MI techniques for PA promotion. Integrating an avatar in such an intervention could lead to more positive appreciation and higher efficacy of the intervention, compared to an intervention that is purely text-based. The present study aims to determine whether a Web-based PA intervention based on MI with an avatar results in more positive appreciation and higher effectiveness of the intervention, when compared to an intervention that is purely text-based. A three-arm randomized controlled trial was conducted, containing the following research conditions: (1) a Web-based PA intervention based on MI with an avatar, (2) a content-identical intervention without an avatar, and (3) a control condition that received no intervention. Measurements included PA behavior and process variables, measured at baseline, directly following the intervention and 1 month post intervention. Both interventions significantly increased self-reported PA at 1 month, compared to the control condition (beta(AVATARvsCONTROL)=.39, P=.011; beta(TEXTvsCONTROL)=.44, P=.006). No distinctions were found regarding intervention effect on PA between both interventions. Similarly, the results of the process evaluation did not indicate any significant differences between both interventions. Due to the limited relational skills of the avatar in this study, it probably did not succeed in forming a stronger relationship with the user, over and above text alone. The findings suggest that avatars that do not strengthen the social relationship with the user do not enhance the intervention impact. Future research should determine whether Web-based PA interventions based on MI could benefit from inclusion of a virtual coach capable of more complex relational skills than used in the current study, such as responding in gesture to the user's state and input. Dutch Trial

  9. A randomized comparative trial of two decision tools for pregnant women with prior cesareans.

    PubMed

    Eden, Karen B; Perrin, Nancy A; Vesco, Kimberly K; Guise, Jeanne-Marie

    2014-01-01

    Evaluate tools to help pregnant women with prior cesareans make informed decisions about having trials of labor. Randomized comparative trial. A research assistant with a laptop met the women in quiet locations at clinics and at health fairs. Pregnant women (N = 131) who had one prior cesarean and were eligible for vaginal birth after cesarean (VBAC) participated one time between 2005 and 2007. Women were randomized to receive either an evidence-based, interactive decision aid or two evidence-based educational brochures about cesarean delivery and VBAC. Effect on the decision-making process was assessed before and after the interventions. Compared to baseline, women in both groups felt more informed (F = 23.8, p < .001), were more clear about their birth priorities (F = 9.7, p = .002), felt more supported (F = 9.8, p = .002, and overall reported less conflict (F = 18.1, p < 0.001) after receiving either intervention. Women in their third trimesters reported greater clarity around birth priorities after using the interactive decision aid than women given brochures (F = 9.8, p = .003). Although both decision tools significantly reduced conflict around the birth decision compared to baseline, more work is needed to understand which format, the interactive decision aid or paper brochures, are more effective early and late in pregnancy. © 2014 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

  10. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    PubMed

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Adaptation and Dissemination of an Evidence-Based Obesity Prevention Intervention: Design of a Comparative Effectiveness Trial

    PubMed Central

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L.; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L.; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L.

    2014-01-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program--Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. PMID:24952282

  12. Effect of affordable technology on physical activity levels and mobility outcomes in rehabilitation: a protocol for the Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial.

    PubMed

    Hassett, Leanne; van den Berg, Maayken; Lindley, Richard I; Crotty, Maria; McCluskey, Annie; van der Ploeg, Hidde P; Smith, Stuart T; Schurr, Karl; Killington, Maggie; Bongers, Bert; Howard, Kirsten; Heritier, Stephane; Togher, Leanne; Hackett, Maree; Treacy, Daniel; Dorsch, Simone; Wong, Siobhan; Scrivener, Katharine; Chagpar, Sakina; Weber, Heather; Pearson, Ross; Sherrington, Catherine

    2016-06-06

    People with mobility limitations can benefit from rehabilitation programmes that provide a high dose of exercise. However, since providing a high dose of exercise is logistically challenging and resource-intensive, people in rehabilitation spend most of the day inactive. This trial aims to evaluate the effect of the addition of affordable technology to usual care on physical activity and mobility in people with mobility limitations admitted to inpatient aged and neurological rehabilitation units compared to usual care alone. A pragmatic, assessor blinded, parallel-group randomised trial recruiting 300 consenting rehabilitation patients with reduced mobility will be conducted. Participants will be individually randomised to intervention or control groups. The intervention group will receive technology-based exercise to target mobility and physical activity problems for 6 months. The technology will include the use of video and computer games/exercises and tablet applications as well as activity monitors. The control group will not receive any additional intervention and both groups will receive usual inpatient and outpatient rehabilitation care over the 6-month study period. The coprimary outcomes will be objectively assessed physical activity (proportion of the day spent upright) and mobility (Short Physical Performance Battery) at 6 months after randomisation. Secondary outcomes will include: self-reported and objectively assessed physical activity, mobility, cognition, activity performance and participation, utility-based quality of life, balance confidence, technology self-efficacy, falls and service utilisation. Linear models will assess the effect of group allocation for each continuously scored outcome measure with baseline scores entered as a covariate. Fall rates between groups will be compared using negative binomial regression. Primary analyses will be preplanned, conducted while masked to group allocation and use an intention-to-treat approach. The

  13. Feedback-Driven Trial-by-Trial Learning in Autism Spectrum Disorders

    PubMed Central

    Solomon, Marjorie; Frank, Michael J.; Ragland, J. Daniel; Smith, Anne C.; Niendam, Tara A.; Lesh, Tyler A.; Grayson, David S.; Beck, Jonathan S.; Matter, John C.; Carter, Cameron S.

    2017-01-01

    Objective Impairments in learning are central to autism spectrum disorders. The authors investigated the cognitive and neural basis of these deficits in young adults with autism spectrum disorders using a well-characterized probabilistic reinforcement learning paradigm. Method The probabilistic selection task was implemented among matched participants with autism spectrum disorders (N=22) and with typical development (N=25), aged 18–40 years, using rapid event-related functional MRI. Participants were trained to choose the correct stimulus in high-probability (AB), medium-probability (CD), and low-probability (EF) pairs, presented with valid feedback 80%, 70%, and 60% of the time, respectively. Whole-brain voxel-wise and parametric modulator analyses examined early and late learning during the stimulus and feedback epochs of the task. Results The groups exhibited comparable performance on medium- and low-probability pairs. Typically developing persons showed higher accuracy on the high-probability pair, better win-stay performance (selection of the previously rewarded stimulus on the next trial of that type), and more robust recruitment of the anterior and medial prefrontal cortex during the stimulus epoch, suggesting development of an intact reward-based working memory for recent stimulus values. Throughout the feedback epoch, individuals with autism spectrum disorders exhibited greater recruitment of the anterior cingulate and orbito-frontal cortices compared with individuals with typical development, indicating continuing trial-by-trial activity related to feedback processing. Conclusions Individuals with autism spectrum disorders exhibit learning deficits reflecting impaired ability to develop an effective reward-based working memory to guide stimulus selection. Instead, they continue to rely on trial-by-trial feedback processing to support learning dependent upon engagement of the anterior cingulate and orbito-frontal cortices. PMID:25158242

  14. Comparing nasal packing with trans-septal suturing following septoplasty: a randomized clinical trial.

    PubMed

    Dadgarnia, Mohammadhossein; Meybodian, Mojtaba; Karbasi, Akbar; Baradaranfar, Mohammadhossein; Atighechi, Saeid; Zand, Vahid; Vaziribozorg, Sedighe

    2017-09-01

    It has been shown that nasal packing after septoplasty is associated with several complications. Our aim was to compare post-septoplasty nasal packing and trans-septal suturing, in terms of complications and outcome of operation. This randomized clinical trial was performed on patients with deviated nasal septum who were candidates for septoplasty. Patients were visited three times after operation (on the first 48 h, first week, and third post-operative month). Participants were checked for having common complications. Rhinomanometric evaluation was performed to measure nasal air flow and airway resistance, as indicators of operation efficacy, both prior to and after surgery. A total of 72 patients were allocated into the two trial arms. Patients in nasal pack group reported higher pain scores on the first 48 h (P < 0.001) and one week after surgery (P < 0.001). Epiphora (P = 0.028), sleep disturbance (P = 0.012), and dyspnea (P < 0.001) were also more commonly observed in patients using nasal pack. Objective evaluation of bleeding demonstrated that more severe bleeding occurred in patients with trans-septal sutures (P = 0.001). No differences were found comparing the indices of rhinomanometry between the two groups. Using trans-septal sutures after septoplasty compared to nasal packing, might be associated with lower frequencies of several specific complications and a lower rate of patients' discomfort. Nevertheless, increase in the risk of bleeding and hematoma was noted in the trans-septal suture group. No differences were observed between the nasal air flow and resistance of patients in the two groups.

  15. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    PubMed

    Titov, Nickolai; Andrews, Gavin; Davies, Matthew; McIntyre, Karen; Robinson, Emma; Solley, Karen

    2010-06-08

    Internet-based cognitive behavioural therapy (iCBT) for depression is effective when guided by a clinician, less so if unguided. Would guidance from a technician be as effective as guidance from a clinician? Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II) and the Patient Health QUESTIONnaire-9 Item (PHQ-9). Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001) and PHQ-9 (p<0.001) compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large scale trials to determine the clinical effectiveness and

  16. A randomised controlled trial of an active telephone-based recruitment strategy to increase childcare-service staff attendance at a physical activity and nutrition training workshop.

    PubMed

    Yoong, Sze Lin; Wolfenden, Luke; Finch, Meghan; Williams, Amanda; Dodds, Pennie; Gillham, Karen; Wyse, Rebecca

    2013-12-01

    Centre-based childcare services represent a promising setting to target the prevention of excessive weight gain in preschool-aged children. Staff training is a key component of multi-strategy interventions to improve implementation of effective physical activity and nutrition promoting practices for obesity prevention in childcare services. This randomised controlled trial aimed to examine whether an active telephone-based strategy to invite childcare-service staff to attend a training workshop was effective in increasing the proportion of services with staff attending training, compared with a passive strategy. Services were randomised to an active telephone-based or a passive-recruitment strategy. Those in the active arm received an email invitation and one to three follow-up phone calls, whereas services in the passive arm were informed of the availability of training only via newsletters. The proportion of services with staff attending the training workshop was compared between the two arms. One hundred and twenty-eight services were included in this study. A significantly larger proportion (52%) of services in the active arm compared with those in the passive-strategy arm (3.1%) attended training (d.f.=1, χ2=34.3; P<0.001). An active, telephone-based recruitment strategy significantly increased the proportion of childcare services with staff attending training. Further strategies to improve staff attendance at training need to be identified and implemented. SO WHAT?: Active-recruitment strategies including follow-up telephone calls should be utilised to invite staff to participate in training, in order to maximise the use of training as an implementation strategy for obesity prevention in childcare services.

  17. Comparing accelerometer, pedometer and a questionnaire for measuring physical activity in bronchiectasis: a validity and feasibility study?

    PubMed

    O'Neill, B; McDonough, S M; Wilson, J J; Bradbury, I; Hayes, K; Kirk, A; Kent, L; Cosgrove, D; Bradley, J M; Tully, M A

    2017-01-14

    There are challenges for researchers and clinicians to select the most appropriate physical activity tool, and a balance between precision and feasibility is needed. Currently it is unclear which physical activity tool should be used to assess physical activity in Bronchiectasis. The aim of this research is to compare assessment methods (pedometer and IPAQ) to our criterion method (ActiGraph) for the measurement of physical activity dimensions in Bronchiectasis (BE), and to assess their feasibility and acceptability. Patients in this analysis were enrolled in a cross-sectional study. The ActiGraph and pedometer were worn for seven consecutive days and the IPAQ was completed for the same period. Statistical analyses were performed using SPSS 20 (IBM). Descriptive statistics were used; the percentage agreement between ActiGraph and the other measures were calculated using limits of agreement. Feedback about the feasibility of the activity monitors and the IPAQ was obtained. There were 55 (22 male) data sets available. For step count there was no significant difference between the ActiGraph and Pedometer, however, total physical activity time (mins) as recorded by the ActiGraph was significantly higher than the pedometer (mean ± SD, 232 (75) vs. 63 (32)). Levels of agreement between the two devices was very good for step count (97% agreement); and variation in the levels of agreement were within accepted limits of ±2 standard deviations from the mean value. IPAQ reported more bouted- moderate - vigorous physical activity (MVPA) [mean, SD; 167(170) vs 6(9) mins/day], and significantly less sedentary time than ActiGraph [mean, SD; 362(115) vs 634(76) vmins/day]. There were low levels of agreement between the two tools (57% sedentary behaviour; 0% MVPA 10+ ), with IPAQ under-reporting sedentary behaviour and over-reporting MVPA 10+ compared to ActiGraph. The monitors were found to be feasible and acceptable by participants and researchers; while the IPAQ was

  18. TaylorActive--Examining the effectiveness of web-based personally-tailored videos to increase physical activity: a randomised controlled trial protocol.

    PubMed

    Vandelanotte, C; Short, C; Plotnikoff, R C; Hooker, C; Canoy, D; Rebar, A; Alley, S; Schoeppe, S; Mummery, W K; Duncan, M J

    2015-10-05

    Physical inactivity levels are unacceptably high and effective interventions that can increase physical activity in large populations at low cost are urgently needed. Web-based interventions that use computer-tailoring have shown to be effective, though people tend to 'skim' and 'scan' text on the Internet rather than thoroughly read it. The use of online videos is, however, popular and engaging. Therefore, the aim of this 3-group randomised controlled trial is to examine whether a web-based physical activity intervention that provides personally-tailored videos is more effective when compared with traditional personally-tailored text-based intervention and a control group. In total 510 Australians will be recruited through social media advertisements, e-mail and third party databases. Participants will be randomised to one of three groups: text-tailored, video-tailored, or control. All groups will gain access to the same web-based platform and a library containing brief physical activity articles. The text-tailored group will additionally have access to 8 sessions of personalised physical activity advice that is instantaneously generated based on responses to brief online surveys. The theory-based advice will be provided over a period of 3 months and address constructs such as self-efficacy, motivation, goal setting, intentions, social support, attitudes, barriers, outcome expectancies, relapse prevention and feedback on performance. Text-tailored participants will also be able to complete 7 action plans to help them plan what, when, where, who with, and how they will become more active. Participants in the video-tailored group will gain access to the same intervention content as those in the text-tailored group, however all sessions will be provided as personalised videos rather than text on a webpage. The control group will only gain access to the library with generic physical activity articles. The primary outcome is objectively measured physical activity

  19. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment.

    PubMed

    Hróbjartsson, A; Gøtzsche, P C

    2004-08-01

    It is widely believed that placebo interventions induce powerful effects. We could not confirm this in a systematic review of 114 randomized trials that compared placebo-treated with untreated patients. To study whether a new sample of trials would reproduce our earlier findings, and to update the review. Systematic review of trials that were published since our last search (or not previously identified), and of all available trials. Data was available in 42 out of 52 new trials (3212 patients). The results were similar to our previous findings. The updated review summarizes data from 156 trials (11 737 patients). We found no statistically significant pooled effect in 38 trials with binary outcomes, relative risk 0.95 (95% confidence interval 0.89-1.01). The effect on continuous outcomes decreased with increasing sample size, and there was considerable variation in effect also between large trials; the effect estimates should therefore be interpreted cautiously. If this bias is disregarded, the pooled standardized mean difference in 118 trials with continuous outcomes was -0.24 (-0.31 to -0.17). For trials with patient-reported outcomes the effect was -0.30 (-0.38 to -0.21), but only -0.10 (-0.20 to 0.01) for trials with observer-reported outcomes. Of 10 clinical conditions investigated in three trials or more, placebo had a statistically significant pooled effect only on pain or phobia on continuous scales. We found no evidence of a generally large effect of placebo interventions. A possible small effect on patient-reported continuous outcomes, especially pain, could not be clearly distinguished from bias.

  20. Internet Treatment for Generalized Anxiety Disorder: A Randomized Controlled Trial Comparing Clinician vs. Technician Assistance

    PubMed Central

    Robinson, Emma; Titov, Nickolai; Andrews, Gavin; McIntyre, Karen; Schwencke, Genevieve; Solley, Karen

    2010-01-01

    Background Internet-based cognitive behavioural therapy (iCBT) for generalized anxiety disorder (GAD) has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. Method Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ) and the Generalized Anxiety Disorder-7 Item (GAD-7). Completion rates were high, and both treatment groups reduced scores on the PSWQ (p<0.001) and GAD-7 (p<0.001) compared to the delayed treatment group, but did not differ from each other. Within group effect sizes on the PSWQ were 1.16 and 1.07 for the clinician- and technician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. Conclusions Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment/control group did not

  1. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial.

    PubMed

    Wang, Chenchen; Iversen, Maura D; McAlindon, Timothy; Harvey, William F; Wong, John B; Fielding, Roger A; Driban, Jeffrey B; Price, Lori Lyn; Rones, Ramel; Gamache, Tressa; Schmid, Christopher H

    2014-09-08

    Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults ≥ 40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind

  2. The Pittsburgh Randomized Trial of Tacrolimus Compared to Cyclosporine for Hepatic Transplantation

    PubMed Central

    Fung, John J.; Eliasziw, Michael; Todo, Satoru; Jain, Ashok; Demetris, Anthony J.; McMichael, John P.; Starzl, Thomas E.; Meier, Paul; Donner, Allan

    2009-01-01

    Background Tacrolimus (formerly FK 506) was first used clinically in 1989 to successfully replace cyclosporine in hepatic transplant recipients who were experiencing intractable rejection or as the baseline drug from the time of operation. After extensive pilot experience, an institutional review board-mandated clinical trial comparing cyclosporine with tacrolimus was performed. Study Design From February 16, 1990 to December 26, 1991, 154 patients were recruited. The competing drugs were combined with equal induction doses of prednisone in both arms of the study for the first 81 patients and with subsequently higher doses of prednisone in the remaining 35 patients who received cyclosporine and were entered into the trial. Drug crossover was permitted for lack of efficacy or adverse events. End points were rejection confirmed by biopsy and treatment failure leading to retransplantation or death. Results Seventy-nine patients were randomized to the tacrolimus arm and 75 to the cyclosporine arm during 1990 and 1991. All patients were available for follow-up throughout the trial, which terminated on May 30, 1995. The mean duration of follow-up was four years. Patients randomized to the tacrolimus arm were less likely to experience acute rejection than were those receiving cyclosporine, with 36.2 percent of the patients receiving tacrolimus and 16.8 percent of the patients receiving cyclosporine showing freedom from rejection at one year (p=0.003, likelihood ratio test). Survival of patients over the course of the study was virtually the same in the two groups. Conclusions Tacrolimus was more effective than cyclosporine in preventing acute rejection. PMID:8696542

  3. Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes

    PubMed Central

    2013-01-01

    Background The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. Methods/design This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. Discussion This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active

  4. A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

    PubMed

    Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

    2017-08-01

    The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

  5. A Randomized Controlled Trial of an Activity Specific Exercise Program for Individuals With Alzheimer Disease in Long-term Care Settings

    PubMed Central

    Roach, Kathryn E.; Tappen, Ruth M.; Kirk-Sanchez, Neva; Williams, Christine L.; Loewenstein, David

    2011-01-01

    Objective To determine whether an activity specific exercise program could improve ability to perform basic mobility activities in long-term care residents with Alzheimer disease (AD). Design Randomized, controlled, single-blinded clinical trial. Setting Residents of 7 long-term care facilities. Participants Eighty-two long-term care residents with mild to severe AD. Intervention An activity specific exercise program was compared to a walking program and to an attention control. Measurements Ability to perform bed mobility and transfers were assessed using the subscales of the Acute Care Index of Function; functional mobility was measured using the 6-Minute Walk test. Results Subjects receiving the activity specific exercise program improved in ability to perform transfers, whereas subjects in the other 2 groups declined. PMID:21937893

  6. Randomised controlled trial of oxytocin alone versus oxytocin and ergometrine in active management of third stage of labour.

    PubMed Central

    McDonald, S J; Prendiville, W J; Blair, E

    1993-01-01

    OBJECTIVE--To compare intramuscular oxytocin alone and intramuscular oxytocin with ergometrine (Syntometrine) for their effect in reducing the risk of postpartum haemorrhage when both are used as part of the active management of the third stage of labour. DESIGN--Double blind, randomised controlled trial. SETTING--Two metropolitan teaching hospitals in Perth, Western Australia. SUBJECTS--All women who expected a vaginal birth during the period of the trial. Informed consent was obtained. MAIN OUTCOME MEASURES--Postpartum haemorrhage, nausea, vomiting, and increased blood pressure. RESULTS--3497 women were randomly allocated to receive oxytocin-ergometrine (n = 1730) or oxytocin (n = 1753). Rates of postpartum haemorrhage (> or = 500 ml or > or = 1000 ml) were similar in both arms (odds ratio 0.90 (0.82); 95% confidence interval 0.75 to 1.07 (0.59 to 1.14) at 500 ml (1000 ml) threshold). The use of oxytocin-ergometrine was associated with nausea, vomiting, and increased blood pressure. CONCLUSIONS--There are few advantages but several disadvantages for the routine use of oxytoxinergometrine when prophylactic active management of the third stage of labour is practised. Further investigation of dose-response for oxytocin may be warranted. PMID:8251842

  7. Behavioural activation by mental health nurses for late-life depression in primary care: a randomized controlled trial.

    PubMed

    Janssen, Noortje; Huibers, Marcus J H; Lucassen, Peter; Voshaar, Richard Oude; van Marwijk, Harm; Bosmans, Judith; Pijnappels, Mirjam; Spijker, Jan; Hendriks, Gert-Jan

    2017-06-26

    Depressive symptoms are common in older adults. The effectiveness of pharmacological treatments and the availability of psychological treatments in primary care are limited. A behavioural approach to depression treatment might be beneficial to many older adults but such care is still largely unavailable. Behavioural Activation (BA) protocols are less complicated and more easy to train than other psychological therapies, making them very suitable for delivery by less specialised therapists. The recent introduction of the mental health nurse in primary care centres in the Netherlands has created major opportunities for improving the accessibility of psychological treatments for late-life depression in primary care. BA may thus address the needs of older patients while improving treatment outcome and lowering costs.The primary objective of this study is to compare the effectiveness and cost-effectiveness of BA in comparison with treatment as usual (TAU) for late-life depression in Dutch primary care. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression. Cluster-randomised controlled multicentre trial with two parallel groups: a) behavioural activation, and b) treatment as usual, conducted in primary care centres with a follow-up of 52 weeks. The main inclusion criterion is a PHQ-9 score > 9. Patients are excluded from the trial in case of severe mental illness that requires specialized treatment, high suicide risk, drug and/or alcohol abuse, prior psychotherapy, change in dosage or type of prescribed antidepressants in the previous 12 weeks, or moderate to severe cognitive impairment. The intervention consists of 8 weekly 30-min BA sessions delivered by a trained mental health nurse. We expect BA to be an effective and cost-effective treatment for late-life depression compared to TAU. BA delivered by mental health nurses could increase the availability and

  8. Comparing ICD9-encoded diagnoses and NLP-processed discharge summaries for clinical trials pre-screening: a case study.

    PubMed

    Li, Li; Chase, Herbert S; Patel, Chintan O; Friedman, Carol; Weng, Chunhua

    2008-11-06

    The prevalence of electronic medical record (EMR) systems has made mass-screening for clinical trials viable through secondary uses of clinical data, which often exist in both structured and free text formats. The tradeoffs of using information in either data format for clinical trials screening are understudied. This paper compares the results of clinical trial eligibility queries over ICD9-encoded diagnoses and NLP-processed textual discharge summaries. The strengths and weaknesses of both data sources are summarized along the following dimensions: information completeness, expressiveness, code granularity, and accuracy of temporal information. We conclude that NLP-processed patient reports supplement important information for eligibility screening and should be used in combination with structured data.

  9. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial.

    PubMed

    McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

    2015-07-01

    The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared with usual outpatient rehabilitation on activity and participation in people <3 months poststroke. An exploratory, single-blind, randomized controlled trial, with a usual-care control arm, was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either usual care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self-Efficacy Gauge. A total of 35 eligible participants were randomized; 26 completed the intervention. Post intervention, PQRS change scores demonstrated that CO-OP had a medium effect over usual care on trained self-selected activities (d = 0.5) and a large effect on untrained activities (d = 1.2). At a 3-month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d = 1.6) and untrained activities (d = 1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and on the Self-Efficacy Gauge. CO-OP was associated with a large treatment effect on follow-up performances of self-selected activities and demonstrated transfer to untrained activities. A larger trial is warranted. © The Author(s) 2014.

  10. SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic

  11. Comparative effects of 12 weeks of equipment based and mat Pilates in patients with Chronic Low Back Pain on pain, function and transversus abdominis activation. A randomized controlled trial.

    PubMed

    Cruz-Díaz, David; Bergamin, M; Gobbo, S; Martínez-Amat, Antonio; Hita-Contreras, Fidel

    2017-08-01

    Pilates method has been recommended for patients with chronic low back pain (CLBP) and the activation of transversus abdominis has been deemed to play an important role in the improvement of these patients. Nevertheless, the evidence of the activation of TrA in Pilates practitioners remains unclear. To assess the effectiveness of 12 weeks of Pilates practice in disability, pain, kinesiophobia and transversus abdominis activation in patients with chronic nonspecific Low Back Pain. A randomized controlled trial was carried out. A single-blind randomized controlled trial with repeated measures at 6 and 12 weeks was carried out. A total of ninety eight patients with low back pain were included and randomly allocated to a Pilates Mat group (PMG) equipment based with apparatus Pilates (PAG) or control group (CG). Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) Tampa Scale of Kinesiophobia (TSK), and transversus abdominis (TrA) activation assessed by real time ultrasound measurement (US) were assessed as outcome measures. Improvement were observed in both intervention groups in all the included variables at 6 and 12 weeks (p<0.001). Faster enhancement was observed in the equipment based Pilates group (p=0.007). Equipment based and mat Pilates modalities are both effective in the improvement of TaA activation in patients with CLBP with associate improvement on pain, function and kinesiophobia. Significant differences were observed after 12 weeks of intervention in PMG and PAG with faster improvement in PAG suggesting that, feedback provided by equipment could help in the interiorization of Pilates principles. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

    USDA-ARS?s Scientific Manuscript database

    To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

  13. How Accurate Is Your Activity Tracker? A Comparative Study of Step Counts in Low-Intensity Physical Activities.

    PubMed

    Alinia, Parastoo; Cain, Chris; Fallahzadeh, Ramin; Shahrokni, Armin; Cook, Diane; Ghasemzadeh, Hassan

    2017-08-11

    As commercially available activity trackers are being utilized in clinical trials, the research community remains uncertain about reliability of the trackers, particularly in studies that involve walking aids and low-intensity activities. While these trackers have been tested for reliability during walking and running activities, there has been limited research on validating them during low-intensity activities and walking with assistive tools. The aim of this study was to (1) determine the accuracy of 3 Fitbit devices (ie, Zip, One, and Flex) at different wearing positions (ie, pants pocket, chest, and wrist) during walking at 3 different speeds, 2.5, 5, and 8 km/h, performed by healthy adults on a treadmill; (2) determine the accuracy of the mentioned trackers worn at different sites during activities of daily living; and (3) examine whether intensity of physical activity (PA) impacts the choice of optimal wearing site of the tracker. We recruited 15 healthy young adults to perform 6 PAs while wearing 3 Fitbit devices (ie, Zip, One, and Flex) on their chest, pants pocket, and wrist. The activities include walking at 2.5, 5, and 8 km/h, pushing a shopping cart, walking with aid of a walker, and eating while sitting. We compared the number of steps counted by each tracker with gold standard numbers. We performed multiple statistical analyses to compute descriptive statistics (ie, ANOVA test), intraclass correlation coefficient (ICC), mean absolute error rate, and correlation by comparing the tracker-recorded data with that of the gold standard. All the 3 trackers demonstrated good-to-excellent (ICC>0.75) correlation with the gold standard step counts during treadmill experiments. The correlation was poor (ICC<0.60), and the error rate was significantly higher in walker experiment compared to other activities. There was no significant difference between the trackers and the gold standard in the shopping cart experiment. The wrist worn tracker, Flex, counted several

  14. A Web-Based, Social Networking Physical Activity Intervention for Insufficiently Active Adults Delivered via Facebook App: Randomized Controlled Trial.

    PubMed

    Maher, Carol; Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim

    2015-07-13

    activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366239 (Archived by WebCite at http://www.webcitation.org/6ZVtu6TMz).

  15. Behavioural intervention to increase physical activity among patients with coronary heart disease: protocol for a randomised controlled trial.

    PubMed

    Alsaleh, Eman; Blake, Holly; Windle, Richard

    2012-12-01

    Although physical activity has significant health benefits in the treatment of patients with coronary heart disease, patients often do not follow prescribed physical activity recommendations. Behavioural strategies have been shown to be efficacious in increasing physical activity among those patients with coronary heart disease who are attending structured cardiac rehabilitation programmes. Research has also shown that tailoring consultation according to patients' needs and sending motivational reminders are successful ways of motivating patients to be physically active. However, there is a lack of evidence for the efficacy of behavioural interventions based on individualised consultation in promoting physical activity among those patients with coronary heart disease who are not attending structured physical activity programmes. This paper outlines the study protocol for a trial which is currently underway, to examine the effect of a behavioural change intervention delivered through individualised consultation calls and motivational reminder text messages on the level of physical activity among patients with coronary heart disease. Two large hospitals in Jordan. Eligible patients aged between 18 and 70 years, who are clinically stable, are able to perform physical activity and who have access to a mobile telephone have been randomly allocated to control or intervention group. Two-group randomised controlled trial. Behavioural intervention will be compared with usual care in increasing physical activity levels among patients with coronary heart disease. The control group (n=85) will receive advice from their doctors about physical activity as they would in usual practice. The intervention group (n=71) will receive the same advice, but will also receive behavioural change intervention (goal-setting, feed-back, self-monitoring) that will be delivered over a period of six months. Intervention will be delivered through individually tailored face-to-face and telephone

  16. A cluster randomised controlled trial evaluating an incentive-based outdoor physical activity programme to increase outdoor time and prevent myopia in children.

    PubMed

    Ngo, Cheryl S; Pan, Chen-Wei; Finkelstein, Eric A; Lee, Chun-Fan; Wong, Inez B; Ong, Julia; Ang, Marcus; Wong, Tien-Yin; Saw, Seang-Mei

    2014-05-01

    To evaluate an incentive-based intervention to increase time spent outdoors among children in a 9-month cluster randomised controlled trial. Two hundred and eighty-five children aged 6-12 years of age were randomised to the intervention (n = 147) or control arm (n = 138) in the Family incentive trial (FIT). The FIT intervention comprised of targeted education on myopia and good eye care habits, structured weekend outdoor activities and incentives for children to increase their daily steps via pedometers. The main outcome measure was outdoor time, measured by the WHO questionnaire and a 1-week diary. Interim analysis at 6 months showed a significant increase in mean outdoor time per week in the intervention arm (14.75 h week(-1) ) compared to the control arm (12.40 h week(-1) ) as measured by the questionnaire (p = 0.04). However, greater outdoor time was not statistically significant at the end of the trial (15.95 h week(-1) vs 14.34 h in the control group (p = 0.29). There was an increase in outdoor time for children in the incentive-based physical activity outdoor program after 6 months but not at the end of the trial. Further larger school trials with better compliance with the intervention and longer duration could be conducted to evaluate clinical outcomes such as myopic shifts. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

  17. Changes in the Healthy Beverage Index in Response to an Intervention Targeting a Reduction in Sugar-Sweetened Beverage Consumption as Compared to an Intervention Targeting Improvements in Physical Activity: Results from the Talking Health Trial.

    PubMed

    Hedrick, Valisa E; Davy, Brenda M; Myers, Emily A; You, Wen; Zoellner, Jamie M

    2015-12-04

    The recently developed Healthy Beverage Index (HBI) was designed to evaluate overall beverage intake quality (including total fluid consumption and beverage calories), yet no known intervention studies have assessed longitudinal changes to the HBI. The objective of this investigation was to assess changes in HBI scores in response to a sugar-sweetened beverage (SSB) reduction trial as compared to a physical activity comparison group. Participants were enrolled into a six-month, community-based, controlled behavioral trial and randomized into either a SSB reduction group (SIPsmartER) or a physical activity group (MoveMore). Correlations and multilevel mixed-effects linear regression with intention-to-treat analyses are presented. Total HBI score significantly increased for SIPsmartER (n = 149) (mean increase = 7.5 points (5.4, 9.7), p ≤ 0.001) and MoveMore (n = 143) (mean increase = 3.4 points (1.6, 5.2), p ≤ 0.001) participants, with a significant between group effect (p ≤ 0.05), over the six-month intervention. Other significant changes in HBI components for SIPsmartER included increased SSB and total beverage calorie scores, and decreased low-fat milk and diet soda scores. Changes in total HBI scores were significantly correlated with changes in total Healthy Eating Index-2010 scores (r = 0.15, p ≤ 0.01). Our findings suggest that individual HBI component scores, beyond the SSB component, are influenced by intervention strategies that primarily focus on SSB reduction.

  18. Cluster randomized controlled trial of a multilevel physical activity intervention for older adults.

    PubMed

    Kerr, Jacqueline; Rosenberg, Dori; Millstein, Rachel A; Bolling, Khalisa; Crist, Katie; Takemoto, Michelle; Godbole, Suneeta; Moran, Kevin; Natarajan, Loki; Castro-Sweet, Cynthia; Buchner, David

    2018-04-02

    Older adults are the least active population group. Interventions in residential settings may support a multi-level approach to behavior change. In a cluster randomized control trial, 11 San Diego retirement communities were assigned to a physical activity (PA) intervention or a healthy aging attention control condition. Participants were 307 adults over 65 years old. The multilevel PA intervention was delivered with the assistance of peer leaders, who were trained older adult from the retirement communities. Intervention components included individual counseling & self-monitoring with pedometers, group education sessions, group walks, community advocacy and pedestrian community change projects. Intervention condition by time interactions were tested using generalized mixed effects regressions. The primary outcomes was accelerometer measured physical activity. Secondary outcomes were blood pressure and objectively measured physical functioning. Over 70% of the sample were 80 years or older. PA significantly increased in the intervention condition (56 min of moderate-vigorous PA per week; 119 min of light PA) compared with the control condition and remained significantly higher across the 12 month study. Men and participants under 84 years old benefited most from the intervention. There was a significant decrease in systolic (p < .007) and diastolic (p < .02) blood pressure at 6 months. Physical functioning improved but the changes were not statistically significant. Intervention fidelity was high demonstrating feasibility. Changes in PA and blood pressure achieved were comparable to other studies with much younger participants. Men, in particular, avoided a year-long decline in PA. clincialtrials.gov Identifier: NCT01155011 .

  19. Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial

    PubMed Central

    Jennings, Cally; Plotnikoff, Ronald C; Vandelanotte, Corneel

    2016-01-01

    modules vs 18/42, 43%, P=.01) and engagement (110 minutes spent on the website vs 78 minutes, P=.02) compared with other participants. There were no overall retention, adherence, engagement, and satisfaction differences between tailoring + video-coaching and tailoring-only participants. At 9 weeks, physical activity increased from baseline to postintervention in all groups (tailoring + video-coaching: +150 minutes/week; tailoring only: +123 minutes/week; waitlist control: +34 minutes/week). The increase was significantly higher in the tailoring + video-coaching group compared with the control group (P=.01). No significant difference was found between intervention groups and no significant between-group differences were found for physical activity change at 6 months. Conclusions Only small improvements were observed when video-coaching was added to computer-tailored advice in a Web-based physical activity intervention. However, combined Web-based video-coaching and computer-tailored advice was effective in comparison with a control group. More research is needed to determine whether Web-based coaching is more effective than stand-alone computer-tailored advice. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN): 12614000339651; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000339651+&isBasic=True (Archived by WebCite at http://www.webcitation.org/6jTnOv0Ld) PMID:27520283

  20. Clinical Trial of Tailored Activity and Eating Newsletters with Older Rural Women

    PubMed Central

    Walker, Susan Noble; Pullen, Carol H.; Boeckner, Linda; Hageman, Patricia A.; Hertzog, Melody; Oberdorfer, Maureen K.; Rutledge, Matthew J.

    2009-01-01

    Background Unhealthy diet and lack of physical activity increase rural midlife and older women’s risk for chronic diseases and premature death, and they are behind urban residents in meeting Healthy People 2010 objectives. Objectives To compare a tailored intervention based on the Health Promotion Model (HPM) and a generic intervention to increase physical activity and healthy eating among rural women. Methods In a randomized by site community-based controlled clinical trial, Wellness for Women, 225 women aged 50 to 69 years were recruited in two similar rural areas. Over 12 months, women received by mail either 18 generic newsletters or 18 newsletters computer-tailored on HPM behavior-specific cognitions (benefits, barriers, self-efficacy, and interpersonal support), activity, and eating. Outcomes at 6 and 12 months included behavioral markers and biomarkers of physical activity and eating. Data were analyzed by repeated measures ANOVA and χ2 tests (α < .05). Results Both groups significantly increased stretching and strengthening exercise and fruit and vegetable servings and decreased % calories from fat, while only the tailored group increased ≥ moderate intensity activity and decreased % calories from saturated fat from baseline to 6 months. Both groups increased stretching and strengthening exercise, while only the tailored group increased ≥ moderate activity and fruit and vegetable servings and decreased % calories from fat from baseline to 12 months. Both groups had several changes in biomarkers over the study. A higher proportion of women receiving tailored newsletters met Healthy People 2010 criteria for ≥ moderate activity, fruit and vegetable servings, and % calories from fat at 12 months. Discussion Mailed computer-tailored and generic print newsletters facilitated the adoption of change in both activity and eating over 6 months. Tailored newsletters were more efficacious in facilitating change over 12 months. PMID:19289928

  1. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial.

    PubMed

    Yakoot, Mostafa; Salem, Amel

    2012-04-12

    Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared. Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group. Our results could suggest a therapeutically

  2. Active children through individual vouchers - evaluation (ACTIVE): protocol for a mixed method randomised control trial to increase physical activity levels in teenagers.

    PubMed

    James, Michaela; Christian, Danielle; Scott, Samantha; Todd, Charlotte; Stratton, Gareth; McCoubrey, Sarah; Halcox, Julian; Audrey, Suzanne; Ellins, Elizabeth; Brophy, Sinead

    2017-07-11

    Many teenagers are insufficiently active despite the health benefits of physical activity (PA). There is strong evidence to show that inactivity and low fitness levels increase the risk of non-communicable diseases such as coronary heart disease (CHD), type 2 diabetes and breast and colon cancers (Lee et al. Lancet 380:219-29, 2012). A major barrier facing adolescents is accessibility (e.g. cost and lack of local facilities). The ACTIVE project aims to tackle this barrier through a multi-faceted intervention, giving teenagers vouchers to spend on activities of their choice and empowering young people to improve their fitness and PA levels. ACTIVE is a mixed methods randomised control trial in 7 secondary schools in Swansea, South Wales. Quantitative and qualitative measures including PA (cooper run test (CRT), accelerometery over 7 days), cardiovascular (CV) measures (blood pressure, pulse wave analysis) and focus groups will be undertaken at 4 separate time points (baseline, 6 months,12 months and follow-up at 18 months). Intervention schools will receive a multi-component intervention involving 12 months of £20 vouchers to spend on physical activities of their choice, a peer mentor scheme and opportunities to attend advocacy meetings. Control schools are encouraged to continue usual practice. The primary aim is to examine the effect of the intervention in improving cardiovascular fitness. This paper describes the protocol for the ACTIVE randomised control trial, which aims to increase fitness, physical activity and socialisation of teenagers in Swansea, UK via a voucher scheme combined with peer mentoring. Results can contribute to the evidence base on teenage physical activity and, if effective, the intervention has the potential to inform future physical activity interventions and policy. ISRCTN75594310 (Assigned 06/03/2017).

  3. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    PubMed Central

    2012-01-01

    Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance. PMID:22233221

  4. A Randomized Trial Comparing Stapled Rectal Mucosectomy Versus Open and Semiclosed Hemorrhoidectomy.

    PubMed

    Ripetti, Valter; La Vaccara, Vincenzo; Greco, Santi; Arullani, Augusto

    2015-11-01

    Different results have been reported concerning the postoperative outcomes of different surgical approaches for hemorrhoids. We aimed to determine the postoperative outcome following 3 main surgical techniques. A prospective, randomized trial was designed with 180 patients in 3 arms of 60 patients each. The study was conducted from April 1999 to January 2007 at the University Hospital "Campus Bio-Medico di Roma." All of the patients who were referred for hemorrhoid surgery were enrolled according to inclusion and exclusion criteria (ISRCTN12040297). Treatments according to the open, semiclosed, and stapled techniques were compared. Sample size was calculated to determine a difference in terms of the intensity of postoperative pain at the first week and the days required for return to work activity. After 1 week, patients who underwent semiclosed hemorrhoidectomy reported significantly less pain (p < 0.01) and a significant decrease in analgesic intake from the third postoperative day (p < 0.01) than after the other 2 techniques. The patients resumed work ≈11 days after semiclosed and stapled techniques (11.8 and 11.6 days), which was earlier compared with 21.3 days in the open group (p < 0.05). The high number of patients excluded might be considered a limitation of the study, but our selection criteria including patients living within 50 km of the hospital allowed for a low rate (9.4%) of patients lost to follow-up. This study found an earlier resumption of work and less pain in patients who underwent the stapled and semiclosed procedures rather than open, which was associated with more complications, particularly because of a higher rate of stenosis (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A196).

  5. A pilot randomized controlled trial comparing effectiveness of prism glasses, visual search training and standard care in hemianopia.

    PubMed

    Rowe, F J; Conroy, E J; Bedson, E; Cwiklinski, E; Drummond, A; García-Fiñana, M; Howard, C; Pollock, A; Shipman, T; Dodridge, C; MacIntosh, C; Johnson, S; Noonan, C; Barton, G; Sackley, C

    2017-10-01

    Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only). Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units. Stroke survivors with homonymous hemianopia. Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only). Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent. Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks. Randomization block lists stratified by site and partial/complete hemianopia. Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation. Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree 2 visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19

  6. Multidisciplinary intensive functional restoration versus outpatient active physiotherapy in chronic low back pain: a randomized controlled trial.

    PubMed

    Roche-Leboucher, Ghislaine; Petit-Lemanac'h, Audrey; Bontoux, Luc; Dubus-Bausière, Valérie; Parot-Shinkel, Elsa; Fanello, Serge; Penneau-Fontbonne, Dominique; Fouquet, Natacha; Legrand, Erick; Roquelaure, Yves; Richard, Isabelle

    2011-12-15

    Randomized parallel group comparative trial with a 1-year follow-up period. To compare in a population of patients with chronic low back pain, the effectiveness of a functional restoration program (FRP), including intensive physical training and a multidisciplinary approach, with an outpatient active physiotherapy program at 1-year follow-up. Controlled studies conducted in the United States and in Northern Europe showed a benefit of FRPs, especially on return to work. Randomized studies have compared these programs with standard care. A previously reported study presented the effectiveness at 6 months of both functional restoration and active physiotherapy, with a significantly greater reduction of sick-leave days for functional restoration. A total of 132 patients with low back pain were randomized to either FRP (68 patients) or active individual therapy (64 patients). One patient did not complete the FRP; 19 patients were lost to follow-up (4 in the FRP group and 15 in the active individual treatment group). The number of sick-leave days in 2 years before the program was similar in both groups (180 ± 135.1 days in active individual treatment vs. 185 ± 149.8 days in FRP, P = 0.847). In both groups, at 1-year follow-up, intensity of pain, flexibility, trunk muscle endurance, Dallas daily activities and work and leisure scores, and number of sick-leave days were significantly improved compared with baseline. The number of sick-leave days was significantly lower in the FRP group. Both programs are efficient in reducing disability and sick-leave days. The FRP is significantly more effective in reducing sick-leave days. Further analysis is required to determine if this overweighs the difference in costs of both programs.

  7. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder.

    PubMed

    Soorya, Latha V; Siper, Paige M; Beck, Todd; Soffes, Sarah; Halpern, Danielle; Gorenstein, Michelle; Kolevzon, Alexander; Buxbaum, Joseph; Wang, A Ting

    2015-03-01

    This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, Seaver-NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Sixty-nine children with ASD, 8 to 11 years of age, with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and 3 months posttreatment. Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ moderated the interaction effect on social behavior, with higher verbal IQ associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at 3-month follow-up conducted with approximately half the sample (n = 34). These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. Clinical trial registration information-Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder; https://clinicaltrials.gov; NCT01190917. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  8. Employee engagement factors that affect enrollment compared with retention in two coaching programs--the ACTIVATE study.

    PubMed

    Terry, Paul E; Fowles, Jinnet B; Harvey, Lisa

    2010-06-01

    This article describes enrollment and retention results from a randomized controlled trial that tested differences between a traditional worksite health promotion program and an activated consumer program on health behaviors and health status. A control arm was included. Baseline survey and clinical data were collected from 631 of 1628 eligible employees (39% response rate) between March and June of 2005. Retention data were collected in March 2007-12 months into an 18-month program. At baseline, participants in the 6 groups (3 arms in each of 2 companies) were comparable in health status but not in patient activation status. Enrollment of high-risk employees into the 2 individualized coaching programs (one focused on traditional health promotion, the other focused on activated consumer navigation) varied significantly by industry type, smoking status, and patient activation. In contrast, retention in the coaching programs was related to sex, age, and industry type. Our findings suggest that one set of strategies may be needed to encourage program enrollment while a distinctly different set of strategies may be needed to sustain participation.

  9. The Clavicle Trial: A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures.

    PubMed

    Ahrens, Philip M; Garlick, Nicholas I; Barber, Julie; Tims, Emily M

    2017-08-16

    The treatment of displaced midshaft clavicle fractures remains controversial. We undertook a multicenter randomized controlled trial to compare effectiveness and safety between nonoperative management and ORIF (open reduction and internal fixation) for displaced midshaft clavicle fractures in adults. Three hundred and one eligible adult patients were randomized to 1 of the 2 treatment groups and followed at 6 weeks, 3 months, and 9 months after recruitment. The primary outcome was the rate of radiographically evident nonunion at 3 months following treatment. Secondary outcomes were the rate of radiographically evident nonunion at 9 months, limb function measured using the Constant-Murley Score and DASH (Disabilities of the Arm, Shoulder and Hand) score, and patient satisfaction. There was no difference in the proportion of patients with radiographic evidence of nonunion at 3 months between the operative (28%) and nonoperative (27%) groups, whereas at 9 months the proportion with nonunion was significantly lower (p < 0.001) in the operative group (0.8%) than in the nonoperative group (11%). The DASH and Constant-Murley scores and patient satisfaction were all significantly better in the operative group than in the nonoperative group at 6 weeks and 3 months. Although at 3 months there was no evidence that surgery had reduced the rate of nonunion of displaced midshaft clavicle fractures, at 9 months nonoperative treatment had led to a significantly higher nonunion rate (11% compared with <1%). The rate of secondary surgical intervention during the trial period was 12 (11%) of the 147 patients in the nonoperative group. ORIF is a safe and reliable intervention with superior early functional outcomes and should be considered for patients who sustain this common injury. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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

    PubMed

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

    2017-02-01

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

  11. Comparative statistical component analysis of transgenic, cyanophycin-producing potatoes in greenhouse and field trials.

    PubMed

    Schmidt, Kerstin; Schmidtke, Jörg; Mast, Yvonne; Waldvogel, Eva; Wohlleben, Wolfgang; Klemke, Friederike; Lockau, Wolfgang; Hausmann, Tina; Hühns, Maja; Broer, Inge

    2017-08-01

    Potatoes are a promising system for industrial production of the biopolymer cyanophycin as a second compound in addition to starch. To assess the efficiency in the field, we analysed the stability of the system, specifically its sensitivity to environmental factors. Field and greenhouse trials with transgenic potatoes (two independent events) were carried out for three years. The influence of environmental factors was measured and target compounds in the transgenic plants (cyanophycin, amino acids) were analysed for differences to control plants. Furthermore, non-target parameters (starch content, number, weight and size of tubers) were analysed for equivalence with control plants. The huge amount of data received was handled using modern statistical approaches to model the correlation between influencing environmental factors (year of cultivation, nitrogen fertilization, origin of plants, greenhouse or field cultivation) and key components (starch, amino acids, cyanophycin) and agronomic characteristics. General linear models were used for modelling, and standard effect sizes were applied to compare conventional and genetically modified plants. Altogether, the field trials prove that significant cyanophycin production is possible without reduction of starch content. Non-target compound composition seems to be equivalent under varying environmental conditions. Additionally, a quick test to measure cyanophycin content gives similar results compared to the extensive enzymatic test. This work facilitates the commercial cultivation of cyanophycin potatoes.

  12. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    PubMed

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  13. Long term effects of self-determination theory and motivational interviewing in a web-based physical activity intervention: randomized controlled trial.

    PubMed

    Friederichs, Stijn A H; Oenema, Anke; Bolman, Catherine; Lechner, Lilian

    2015-08-18

    Our main objective in the current study was to evaluate the long-term effectiveness (12 months from baseline) of I Move (a web-based computer tailored physical activity intervention, based on self-determination theory and motivational interviewing). To this end, we compared I Move to a web-based computer tailored physical activity intervention based on traditional health behavior theories (Active Plus), and to a no-intervention control group. As a secondary objective, the present study aimed to identify participant characteristics that moderate the long term effects of I Move and Active Plus. A randomized controlled trial was conducted, comparing three research conditions: 1) the I Move condition, participants in this condition received I Move; 2) the Active Plus condition, participants in this condition received Active Plus; 3) the control condition; participants in this condition received no intervention and were placed on a waiting list. Main outcome measures were weekly minutes of moderate to vigorous physical activity and weekly days with minimal 30 min of physical activity. All measurements were taken by web-based questionnaires via the study website. Intervention effects were analyzed using multilevel linear regression analyses. At 12 months from baseline, I Move was found to be effective in increasing weekly minutes of moderate to vigorous physical activity (ES = .13), while Active Plus was not. In contrast, Active Plus was found to be effective in increasing weekly days with ≥ 30 min PA at 12 months (ES = .11), while I Move was not. No moderators of the effects of I Move were found. The results suggest that web-based computer tailored physical activity interventions might best include elements based on both self-determination theory/motivational interviewing and traditional health behavioral theories. To be more precise, it is arguable that the focus of the theoretical foundations, used in new web-based PA interventions should depend on the

  14. Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

    PubMed

    Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

    2018-01-08

    Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the

  15. Efficacy and causal mechanism of an online social media intervention to increase physical activity: Results of a randomized controlled trial.

    PubMed

    Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Centola, Damon

    2015-01-01

    To identify what features of social media - promotional messaging or peer networks - can increase physical activity. A 13-week social media-based exercise program was conducted at a large Northeastern university in Philadelphia, PA. In a randomized controlled trial, 217 graduate students from the University were randomized to three conditions: a control condition with a basic online program for enrolling in weekly exercise classes led by instructors of the University for 13 weeks, a media condition that supplemented the basic program with weekly online promotional media messages that encourage physical activity, and a social condition that replaced the media content with an online network of four to six anonymous peers composed of other participants of the program, in which each participant was able to see their peers' progress in enrolling in classes. The primary outcome was the number of enrollments in exercise classes, and the secondary outcomes were self-reported physical activities. Data were collected in 2014. Participants enrolled in 5.5 classes on average. Compared with enrollment in the control condition (mean = 4.5), promotional messages moderately increased enrollment (mean = 5.7, p = 0.08), while anonymous social networks significantly increased enrollment (mean = 6.3, p = 0.02). By the end of the program, participants in the social condition reported exercising moderately for an additional 1.6 days each week compared with the baseline, which was significantly more than an additional 0.8 days in the control condition. Social influence from anonymous online peers was more successful than promotional messages for improving physical activity. ClinicalTrials.gov: NCT02267369.

  16. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

    PubMed

    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

    2016-12-01

    The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

  17. Graded activity for low back pain in occupational health care: a randomized, controlled trial.

    PubMed

    Staal, J Bart; Hlobil, Hynek; Twisk, Jos W R; Smid, Tjabe; Köke, Albère J A; van Mechelen, Willem

    2004-01-20

    Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. Randomized, controlled trial. Occupational health services department of an airline company in the Netherlands. 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

  18. Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data.

    PubMed

    Feagan, Brian; Sandborn, William J; Rutgeerts, Paul; Levesque, Barrett G; Khanna, Reena; Huang, Bidan; Zhou, Qian; Maa, Jen-Fue; Wallace, Kori; Lacerda, Ana; Thakkar, Roopal B; Robinson, Anne M

    2018-04-23

    Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD. Subsets of patients meeting specified Simplified Endoscopic Score for CD (SES-CD) inclusion criteria, according to site or central reading, and baseline stool frequency (SF) and/or abdominal pain score (AP) thresholds were evaluated. Various endpoint definitions based on the Crohn's Disease Activity Index (CDAI), its SF and AP components, SES-CD, and composite endpoints were compared between treatment groups. Increased stringency of Week 12 clinical endpoints compared to CDAI<150 to SF≤3.0/1.5&AP≤1.0 reduced PBO response rates by ≥12% and increased treatment effects by ≤10%. Amending the SES-CD endpoint from ≤4 to ≤2 reduced the treatment effect from 24% to 8%. Composite endpoints further diminished response rates and effect sizes. Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.

  19. Effectiveness of a smartphone app in increasing physical activity amongst male adults: a randomised controlled trial.

    PubMed

    Harries, Tim; Eslambolchilar, Parisa; Rettie, Ruth; Stride, Chris; Walton, Simon; van Woerden, Hugo C

    2016-09-02

    Smartphones are ideal for promoting physical activity in those with little intrinsic motivation for exercise. This study tested three hypotheses: H1 - receipt of social feedback generates higher step-counts than receipt of no feedback; H2 - receipt of social feedback generates higher step-counts than only receiving feedback on one's own walking; H3 - receipt of feedback on one's own walking generates higher step-counts than no feedback (H3). A parallel group randomised controlled trial measured the impact of feedback on steps-counts. Healthy male participants (n = 165) aged 18-40 were given phones pre-installed with an app that recorded steps continuously, without the need for user activation. Participants carried these with them as their main phones for a two-week run-in and six-week trial. Randomisation was to three groups: no feedback (control); personal feedback on step-counts; group feedback comparing step-counts against those taken by others in their group. The primary outcome measure, steps per day, was assessed using longitudinal multilevel regression analysis. Control variables included attitude to physical activity and perceived barriers to physical activity. Fifty-five participants were allocated to each group; 152 completed the study and were included in the analysis: n = 49, no feedback; n = 53, individual feedback; n = 50, individual and social feedback. The study provided support for H1 and H3 but not H2. Receipt of either form of feedback explained 7.7 % of between-subject variability in step-count (F = 6.626, p < 0.0005). Compared to the control, the expected step-count for the individual feedback group was 60 % higher (effect on log step-count = 0.474, 95 % CI = 0.166-0.782) and that for the social feedback group, 69 % higher (effect on log step-count = 0.526, 95 % CI = 0.212-0.840). The difference between the two feedback groups (individual vs social feedback) was not statistically significant. Always

  20. Ethics and clinical trials.

    PubMed

    Chassany, O; Duracinský, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  1. Comparison of Compliance and Intervention Outcomes Between Hip- and Wrist-Worn Accelerometers During a Randomized Crossover Trial of an Active Video Games Intervention in Children.

    PubMed

    Howie, Erin K; McVeigh, Joanne A; Straker, Leon M

    2016-09-01

    There are several practical issues when considering the use of hip-worn or wrist-worn accelerometers. This study compared compliance and outcomes between hip- and wrist-worn accelerometers worn simultaneously by children during an active video games intervention. As part of a larger randomized crossover trial, participants (n = 73, age 10 to 12 years) wore 2 Actical accelerometers simultaneously during waking hours for 7 days, on the hip and wrist. Measurements were repeated at 4 timepoints: 1) at baseline, 2) during traditional video games condition, 3) during active video games condition, 4) during no video games condition. Compliance and intervention effects were compared between hip and wrist. There were no statistically significant differences at any timepoint in percentage compliance between hip (77% to 87%) and wrist (79% to 89%). Wrist-measured counts (difference of 64.3 counts per minute, 95% CI 4.4-124.3) and moderate-to-vigorous physical activity (MVPA) (12 min/day, 95% CI 0.3-23.7) were higher during the no video games condition compared with the traditional video games condition. There were no differences in hip-measured counts per minute or MVPA between conditions or sedentary time for hip or wrist. There were no differences in compliance between hip- and wrist-worn accelerometers during an intervention trial, however, intervention findings differed between hip and wrist.

  2. 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

    PubMed Central

    Emery, Paul; Vencovský, Jiří; Sylwestrzak, Anna; Leszczyński, Piotr; Porawska, Wieslawa; Baranauskaite, Asta; Tseluyko, Vira; Zhdan, Vyacheslav M.; Stasiuk, Barbara; Milasiene, Roma; Barrera Rodriguez, Aaron Alejandro; Cheong, Soo Yeon; Ghil, Jeehoon

    2017-01-01

    Abstract Objective To compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference etanercept (ETN) in patients with active RA. Methods In a phase 3, randomized, double-blind, multicentre study, patients with moderate to severe RA despite MTX treatment were randomized to receive 50 mg/week of s.c. SB4 or ETN up to week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified and Clinical Disease Activity Indices and changes in the modified total Sharp score (mTSS). Safety and immunogenicity were also evaluated. Results A total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the per-protocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively. Conclusion Efficacy including radiographic progression was comparable between SB4 and ETN up to week 52. SB4 was well tolerated and had a similar safety profile to that of ETN. Trial registration number ClinicalTrials.gov NCT01895309, EudraCT 2012-005026-30 PMID:28968793

  3. The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial.

    PubMed

    Onerup, Aron; Angenete, Eva; Bock, David; Börjesson, Mats; Fagevik Olsén, Monika; Grybäck Gillheimer, Elin; Skullman, Stefan; Thörn, Sven-Egron; Haglind, Eva; Nilsson, Hanna

    2017-05-08

    Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. ClinicalTrials.gov identifier: NCT

  4. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    PubMed Central

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  5. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    PubMed

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  6. Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

    PubMed

    Fleminger, Jessica; Goldacre, Ben

    2018-01-01

    Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

  7. Effects of Sacubitril/Valsartan on Physical and Social Activity Limitations in Patients With Heart Failure: A Secondary Analysis of the PARADIGM-HF Trial.

    PubMed

    Chandra, Alvin; Lewis, Eldrin F; Claggett, Brian L; Desai, Akshay S; Packer, Milton; Zile, Michael R; Swedberg, Karl; Rouleau, Jean L; Shi, Victor C; Lefkowitz, Martin P; Katova, Tzvetana; McMurray, John J V; Solomon, Scott D

    2018-04-04

    Health-related quality of life (HRQL) of patients with heart failure is markedly reduced compared with that in patients with other chronic diseases, demonstrating substantial limitations in physical and social activities. In the Prospective Comparison of ARNI With an ACE-Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial, sacubitril/valsartan improved overall HRQL compared with enalapril, as determined by the Kansas City Cardiomyopathy Questionnaire (KCCQ). To examine the effects of sacubitril/valsartan on physical and social activities. The PARADIGM-HF trial was a randomized, double-blind, active treatment-controlled clinical trial performed from December 8, 2009, to March 31, 2014, in 8399 patients with New York Heart Association class II to IV disease and a left ventricular ejection fraction of 40% or less at 1043 centers in 38 countries. Data analysis was performed from August 1, 2017, to December 25, 2017. Sacubitril/valsartan, 200 mg twice daily, or enalapril, 10 mg twice daily. Patients completed HRQL assessments using the KCCQ at randomization, 4-month, 8-month, and annual visits. The effect of sacubitril/valsartan on components of the physical and social limitation sections of the KCCQ at 8 months and longitudinally and related biomarkers and clinical outcomes were studied. At baseline, 7618 of 8399 patients (90.7%) (mean [SD] age, 64 [11] years; 5987 [78.6%] male and 1631 [21.4%] female) completed the initial KCCQ assessment. Patients reported the greatest limitations at baseline in jogging and sexual relationships. Patients receiving sacubitril/valsartan had significantly better adjusted change scores in most physical and social activities at 8 months and during 36 months compared with those receiving enalapril. The largest improvement over enalapril was in household chores (adjusted change score difference, 2.35; 95% CI, 1.19-3.50; P < .001) and sexual relationships (adjusted change score difference

  8. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial.

    PubMed

    Vink, A C; Zuidersma, M; Boersma, F; de Jonge, P; Zuidema, S U; Slaets, J P J

    2013-10-01

    This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. In a randomised controlled design, residents with dementia (n = 94) were allocated to either music therapy or recreational activities. Both music therapy and general activities were offered twice weekly for 4 months. Changes in agitation were measured with a modified Cohen-Mansfield Agitation Inventory (CMAI) at four intervals on each intervention day. A mixed model analysis was used to evaluate the effectiveness of music therapy, compared with general activities, on CMAI scores at 4 h after the intervention, controlled for CMAI scores at 1 h before the session and session number. Data were analysed for 77 residents (43 randomised to music therapy and 34 to general activities). In both groups, the intervention resulted in a decrease in agitated behaviours from 1 h before to 4 h after each session. This decrease was somewhat greater in the music therapy group than in the general activities group, but this difference was statistically not significant (F = 2.885, p = 0.090) and disappeared completely after adjustment for Global Deterioration Scale stage (F = 1.500; p = 0.222). Both music therapy and recreational activities lead to a short-term decrease in agitation, but there was no additional beneficial effect of music therapy over general activities. More research is required to provide insight in the effects of music therapy in reducing agitation in demented older people. Copyright © 2012 John Wiley & Sons, Ltd.

  9. Fall prevention with supplemental and active forms of vitamin D: a meta-analysis of randomised controlled trials.

    PubMed

    Bischoff-Ferrari, H A; Dawson-Hughes, B; Staehelin, H B; Orav, J E; Stuck, A E; Theiler, R; Wong, J B; Egli, A; Kiel, D P; Henschkowski, J

    2009-10-01

    To test the efficacy of supplemental vitamin D and active forms of vitamin D with or without calcium in preventing falls among older individuals. We searched Medline, the Cochrane central register of controlled trials, BIOSIS, and Embase up to August 2008 for relevant articles. Further studies were identified by consulting clinical experts, bibliographies, and abstracts. We contacted authors for additional data when necessary. Review methods Only double blind randomised controlled trials of older individuals (mean age 65 years or older) receiving a defined oral dose of supplemental vitamin D (vitamin D(3) (cholecalciferol) or vitamin D(2) (ergocalciferol)) or an active form of vitamin D (1alpha-hydroxyvitamin D(3) (1alpha-hydroxycalciferol) or 1,25-dihydroxyvitamin D(3) (1,25-dihydroxycholecalciferol)) and with sufficiently specified fall assessment were considered for inclusion. Eight randomised controlled trials (n=2426) of supplemental vitamin D met our inclusion criteria. Heterogeneity among trials was observed for dose of vitamin D (700-1000 IU/day v 200-600 IU/day; P=0.02) and achieved 25-hydroxyvitamin D(3) concentration (25(OH)D concentration: <60 nmol/l v >or=60 nmol/l; P=0.005). High dose supplemental vitamin D reduced fall risk by 19% (pooled relative risk (RR) 0.81, 95% CI 0.71 to 0.92; n=1921 from seven trials), whereas achieved serum 25(OH)D concentrations of 60 nmol/l or more resulted in a 23% fall reduction (pooled RR 0.77, 95% CI 0.65 to 0.90). Falls were not notably reduced by low dose supplemental vitamin D (pooled RR 1.10, 95% CI 0.89 to 1.35; n=505 from two trials) or by achieved serum 25-hydroxyvitamin D concentrations of less than 60 nmol/l (pooled RR 1.35, 95% CI 0.98 to 1.84). Two randomised controlled trials (n=624) of active forms of vitamin D met our inclusion criteria. Active forms of vitamin D reduced fall risk by 22% (pooled RR 0.78, 95% CI 0.64 to 0.94). Supplemental vitamin D in a dose of 700-1000 IU a day reduced the risk of

  10. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial

    PubMed Central

    2012-01-01

    Background Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. Methods STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate ‘activity’ stages (focus: failure-free survival), and a final ‘efficacy’ stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. Results (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design. (2

  11. Standardizing clinical trials workflow representation in UML for international site comparison.

    PubMed

    de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia M O; Rodrigues, Maria J; Shah, Jatin; Loures, Marco R; Patil, Sunita; Payne, Philip; Pietrobon, Ricardo

    2010-11-09

    With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials

  12. Standardizing Clinical Trials Workflow Representation in UML for International Site Comparison

    PubMed Central

    de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia M. O.; Rodrigues, Maria J.; Shah, Jatin; Loures, Marco R.; Patil, Sunita; Payne, Philip; Pietrobon, Ricardo

    2010-01-01

    Background With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. Methods Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. Results Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. Conclusions This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative

  13. Cognitive Behavioral Therapy vs. Tai Chi for Late Life Insomnia and Inflammatory Risk: A Randomized Controlled Comparative Efficacy Trial

    PubMed Central

    Irwin, Michael R.; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Breen, Elizabeth C.; Witarama, Tuff; Yokomizo, Megumi; Lavretsky, Helen; Carroll, Judith E.; Motivala, Sarosh J.; Bootzin, Richard; Nicassio, Perry

    2014-01-01

    Study Objectives: To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Design: Randomized controlled, comparative efficacy trial. Setting: Los Angeles community. Patients: 123 older adults with chronic and primary insomnia. Interventions: Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Measurements: Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. Results: CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P < 0.01), and also showed greater and more sustained improvement in sleep quality, sleep parameters, fatigue, and depressive symptoms than TCC and SS (all P values < 0.01). As compared to SS, CBT was associated with a reduced risk of high CRP levels (> 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07–0.97] P < 0.05). Remission of insomnia was associated with lower levels of CRP (P < 0.05) at 16 months. TCC was associated with improvements in sleep quality, fatigue, and depressive symptoms as compared to SS (all P's < 0.05), but not insomnia remission. PSG measures did not change. Conclusions: Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. Clinical Trial Registration: ClinicalTrials.gov, NCT00280020 Citation: Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral

  14. Dynamic Trial-by-Trial Recoding of Task-Set Representations in the Frontoparietal Cortex Mediates Behavioral Flexibility

    PubMed Central

    Qiao, Lei; Zhang, Lijie

    2017-01-01

    Cognitive flexibility forms the core of the extraordinary ability of humans to adapt, but the precise neural mechanisms underlying our ability to nimbly shift between task sets remain poorly understood. Recent functional magnetic resonance imaging (fMRI) studies employing multivoxel pattern analysis (MVPA) have shown that a currently relevant task set can be decoded from activity patterns in the frontoparietal cortex, but whether these regions support the dynamic transformation of task sets from trial to trial is not clear. Here, we combined a cued task-switching protocol with human (both sexes) fMRI, and harnessed representational similarity analysis (RSA) to facilitate a novel assessment of trial-by-trial changes in neural task-set representations. We first used MVPA to define task-sensitive frontoparietal and visual regions and found that neural task-set representations on switch trials are less stably encoded than on repeat trials. We then exploited RSA to show that the neural representational pattern dissimilarity across consecutive trials is greater for switch trials than for repeat trials, and that the degree of this pattern dissimilarity predicts behavior. Moreover, the overall neural pattern of representational dissimilarities followed from the assumption that repeating sets, compared with switching sets, results in stronger neural task representations. Finally, when moving from cue to target phase within a trial, pattern dissimilarities tracked the transformation from previous-trial task representations to the currently relevant set. These results provide neural evidence for the longstanding assumptions of an effortful task-set reconfiguration process hampered by task-set inertia, and they demonstrate that frontoparietal and stimulus processing regions support “dynamic adaptive coding,” flexibly representing changing task sets in a trial-by-trial fashion. SIGNIFICANCE STATEMENT Humans can fluently switch between different tasks, reflecting an ability

  15. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    PubMed

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  16. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial.

    PubMed

    Ferrar, Katia Elizabeth; Smith, Ashleigh E; Davison, Kade

    2017-08-01

    Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity-related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant's home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end

  17. Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis.

    PubMed

    Magni, M; Di Nicola, M; Patti, C; Scimè, R; Mulè, A; Rambaldi, A; Intermesoli, T; Viero, P; Tarella, C; Gueli, A; Bergui, L; Trentin, L; Barzan, A; Benedetti, F; Ambrosetti, A; Di Raimondo, F; Chiarenza, A; Parvis, G; Billio, A; Attolico, I; Olivieri, A; Montanari, M; Carlo-Stella, C; Matteucci, P; Devizzi, L; Guidetti, A; Viviani, S; Valagussa, P; Gianni, A M

    2014-04-01

    The importance of early therapy intensification in B-cell CLL (B-CLL) patients remains to be defined. Even though several studies have been published, no randomized trials comparing directly autologous stem cell transplant (ASCT) and the accepted conventional therapy (that is, rituximab, fludarabine and CY; R-FC) have been reported so far. To assess the benefit of a first-line aggressive therapy, we designed a multicenter, randomized, phase 3 trial comparing R-FC and high-dose chemotherapy supported by ASCT in patients under 65 years of age, with stage B(II) or C B-CLL. Primary end point was CR: 96 patients were enrolled (48 in each arm). On an intent-to-treat basis, the CR rates in the ASCT and R-FC arms were 62.5% and 58%, respectively. After 5 years of follow-up, PFS was 60.4% in the ASCT arm and 65.1% in the R-FC arm, time to progression 65.8 and 70.5%, and overall survival 88% vs 88.1%, respectively. Our trial demonstrates, for the first time in a randomized manner, that frontline ASCT does not translate into a survival advantage when compared with benchmark chemoimmunotherapy in B-CLL patients; the possibility of its clinical benefit in certain subgroups remains uncertain.

  18. The protocol for a randomised controlled trial comparing intermittent and graded exercise to usual care for chronic fatigue syndrome patients.

    PubMed

    Broadbent, Suzanne; Coutts, Rosanne

    2013-08-30

    Chronic Fatigue Syndrome is a debilitating disorder with an unknown aetiology but suspected multifactorial origins. Common "triggers" include severe viral infections and emotional stress. Recent studies have also found evidence of immune dysfunction and elevated inflammatory cytokines in CFS patients, but there has been considerable variation in the outcome measures and magnitude of these studies. Currently, there is no cure for CFS but treatments include rest, specialist medical care, cognitive behavioural therapy, and graded (self-paced) exercise. To date, several studies have examined the efficacy of graded exercise with or without Cognitive Behavioural Therapy, with some success for patients. However, improvements in functional capacity have not necessarily correlated with improvements in immune function, fatigue or other symptoms. This 12-week pilot trial compares graded and intermittent exercise to normal care, measuring physiological outcomes, fatigue levels, immune function and wellness. 90 patients aged between 16 to 60 years, who meet the diagnostic criteria for CFS and have been diagnosed by their medical practitioner, will be randomly recruited into groups consisting of Intermittent exercise, Graded exercise and usual care (Control). The outcomes will be measured pre-study (Week 0) and post-study (Week 13). Primary outcomes are VO2peak, anaerobic threshold, peak power, levels of fatigue, immune cell (CD3+CD4+, CD3+CD8+, CD19+, CD 16+CD56+) concentrations and activation. Secondary outcomes include onset of secondary CFS symptoms (e.g. fever, swollen lymph nodes), wellness, mood and sleep patterns. Primary analysis will be based on intention to treat using logistic regression models to compare treatments. Quantitative data will be analysed using repeated measures ANOVA with a linear model, and Cohen's effect size. Qualitative data such as participants' responses (e.g. changes in mood and other reactions) following the exercise modalities will be read and

  19. Psychosocial rehabilitation after war trauma with adaptive disclosure: Design and rationale of a comparative efficacy trial.

    PubMed

    Yeterian, Julie D; Berke, Danielle S; Litz, Brett T

    2017-10-01

    Posttraumatic stress disorder (PTSD) from warzone exposure is associated with chronic and disabling social and occupational problems. However, functional impairment is rarely assessed or targeted directly in PTSD treatments, which instead focus on symptom reduction. Trauma-related contributors to diminished functioning, including guilt, shame, and anger resulting from morally compromising or loss-based war experiences, are also underemphasized. The goal of this clinical trial is to fill a substantial gap in the treatment of military-related PTSD by testing a modified Adaptive Disclosure (AD) therapy for war-related PTSD stemming from moral injury and traumatic loss focused on improving psychosocial functioning AD. This paper describes the rationale and design of a multi-site randomized controlled trial comparing AD to Present-Centered Therapy (PCT). We will recruit 186 veterans with PTSD, who will be assessed at baseline, post-treatment, and 3- and 6-months post-treatment. Primary outcomes are functional changes (i.e., functioning/disability and quality of life). Secondary outcomes are mental health variables (i.e., PTSD, depression, guilt, shame). We hypothesize that veterans treated with AD will experience greater improvements in all outcomes compared to those treated with PCT. This trial will advance knowledge in rehabilitation research by testing the first therapy specifically designed to address psychosocial functioning among veterans with war-related PTSD. The results may improve the quality of mental health care for veterans by offering an ecologically sound treatment for experiences that are uniquely impactful for war veterans. Published by Elsevier Inc.

  20. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility.

    PubMed

    Wójcicki, Thomas R; Grigsby-Toussaint, Diana; Hillman, Charles H; Huhman, Marian; McAuley, Edward

    2014-10-30

    The World Wide Web is an effective method for delivering health behavior programs, yet major limitations remain (eg, cost of development, time and resource requirements, limited interactivity). Social media, however, has the potential to deliver highly customizable and socially interactive behavioral interventions with fewer constraints. Thus, the evaluation of social media as a means to influence health behaviors is warranted. The objective of this trial was to examine and demonstrate the feasibility of using an established social networking platform (ie, Facebook) to deliver an 8 week physical activity intervention to a sample of low-active adolescents (N=21; estimated marginal mean age 13.48 years). Participants were randomized to either an experimental (ie, Behavioral) or attentional control (ie, Informational) condition. Both conditions received access to a restricted-access, study-specific Facebook group where the group's administrator made two daily wall posts containing youth-based physical activity information and resources. Primary outcomes included physical activity as assessed by accelerometry and self-report. Interactions and main effects were examined, as well as mean differences in effect sizes. Analyses revealed significant improvements over time on subjectively reported weekly leisure-time physical activity (F1,18=8.426, P=.009, η2 = .319). However, there was no interaction between time and condition (F1,18=0.002, P=.968, η2 = .000). There were no significant time or interaction effects among the objectively measured physical activity variables. Examination of effect sizes revealed moderate-to-large changes in physical activity outcomes. Results provide initial support for the feasibility of delivery of a physical activity intervention to low-active adolescents via social media. Whether by employing behavioral interventions via social media can result in statistically meaningful changes in health-related behaviors and outcomes remains to be

  1. Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial.

    PubMed

    Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

    2017-02-09

    Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date. This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1 st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm. The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to

  2. Patterns of Fitbit Use and Activity Levels Throughout a Physical Activity Intervention: Exploratory Analysis from a Randomized Controlled Trial

    PubMed Central

    Nelson, Sandahl H; Weiner, Lauren S

    2018-01-01

    Background There has been a rapid increase in the use of technology-based activity trackers to promote behavior change. However, little is known about how individuals use these trackers on a day-to-day basis or how tracker use relates to increasing physical activity. Objective The aims were to use minute level data collected from a Fitbit tracker throughout a physical activity intervention to examine patterns of Fitbit use and activity and their relationships with success in the intervention based on ActiGraph-measured moderate to vigorous physical activity (MVPA). Methods Participants included 42 female breast cancer survivors randomized to the physical activity intervention arm of a 12-week randomized controlled trial. The Fitbit One was worn daily throughout the 12-week intervention. ActiGraph GT3X+ accelerometer was worn for 7 days at baseline (prerandomization) and end of intervention (week 12). Self-reported frequency of looking at activity data on the Fitbit tracker and app or website was collected at week 12. Results Adherence to wearing the Fitbit was high and stable, with a mean of 88.13% of valid days over 12 weeks (SD 14.49%). Greater adherence to wearing the Fitbit was associated with greater increases in ActiGraph-measured MVPA (binteraction=0.35, P<.001). Participants averaged 182.6 minutes/week (SD 143.9) of MVPA on the Fitbit, with significant variation in MVPA over the 12 weeks (F=1.91, P=.04). The majority (68%, 27/40) of participants reported looking at their tracker or looking at the Fitbit app or website once a day or more. Changes in Actigraph-measured MVPA were associated with frequency of looking at one’s data on the tracker (b=−1.36, P=.07) but not significantly associated with frequency of looking at one’s data on the app or website (P=.36). Conclusions This is one of the first studies to explore the relationship between use of a commercially available activity tracker and success in a physical activity intervention. A deeper

  3. Effects of lifestyle physical activity on perceived symptoms and physical function in adults with fibromyalgia: results of a randomized trial

    PubMed Central

    2010-01-01

    Introduction Although exercise is therapeutic for adults with fibromyalgia (FM), its symptoms often create obstacles that discourage exercise. We evaluated the effects of accumulating at least 30 minutes of self-selected lifestyle physical activity (LPA) on perceived physical function, pain, fatigue, body mass index, depression, tenderness, and the six-minute walk test in adults with FM. Methods Eighty-four minimally active adults with FM were randomized to either LPA or a FM education control (FME) group. LPA participants worked toward accumulating 30 minutes of self-selected moderate-intensity LPA, five to seven days per week, while the FME participants received information and support. Results Seventy-three of the 84 participants (87%) completed the 12-week trial. The LPA group increased their average daily steps by 54%. Compared to FME, the LPA group reported significantly less perceived functional deficits (P = .032) and less pain (P = .006). There were no differences between the groups on the six-minute walk test (P = .067), fatigue, depression, body mass index, or tenderness. Conclusions Accumulating 30 minutes of LPA throughout the day produces clinically relevant changes in perceived physical function and pain in previously minimally active adults with FM. Trial Registration clinicaltrials.gov NCT00383084 PMID:20353551

  4. Dose-response effects of a Web-based physical activity program on body composition and metabolic health in inactive older adults: additional analyses of a randomized controlled trial.

    PubMed

    Vroege, David P; Wijsman, Carolien A; Broekhuizen, Karen; de Craen, Anton J M; van Heemst, Diana; van der Ouderaa, Frans J G; van Mechelen, Willem; Slagboom, P Eline; Catt, Michael; Westendorp, Rudi G J; Verhagen, Evert A L M; Mooijaart, Simon P

    2014-12-04

    Low physical activity is a major risk factor for several age-related diseases. Recently, we showed in a randomized controlled trial that a 12-week Web-based intervention (Philips DirectLife) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged 60-70 years. The goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention. Among the 235 participants in a randomized controlled trial of the Actief en Gezond Oud (AGO) study, we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group. Furthermore, we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group. Of the intervention group, 50 of 119 (42.0%) participants successfully reached the physical activity target (corresponding to a 10% increased daily physical activity on average). This group showed markedly higher effects of the intervention compared to the entire intervention group, with greater decreases in body weight (2.74 vs 1.49 kg), waist circumference (3.74 vs 2.33 cm), insulin resistance (HOMA index: 0.23 vs 0.20), and in cholesterol/HDL ratio (0.39 vs 0.20) and Framingham risk score (0.90% vs 0.54%). We found that men compared to women were more likely to be successful. The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss, BMI reduction, waist circumference reduction, HDL cholesterol increasing, and cholesterol/HDL ratio lowering. Of the intervention group, 42.0% (50

  5. Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes.

    PubMed

    Wang, Qiuzhen; Ma, Aiguo; Bygbjerg, Ib Christian; Han, Xiuxia; Liu, Yufeng; Zhao, Shanliang; Cai, Jing

    2013-02-26

    The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients. This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L. This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM. ChiCTR-TRC-12002546.

  6. Occupational therapy for patients with problems in personal activities of daily living after stroke: systematic review of randomised trials

    PubMed Central

    Drummond, Avril; Leonardi-Bee, Jo; Gladman, J R F; Donkervoort, Mireille; Edmans, Judi; Gilbertson, Louise; Jongbloed, Lyn; Logan, Pip; Sackley, Catherine; Walker, Marion; Langhorne, Peter

    2007-01-01

    Objective To determine whether occupational therapy focused specifically on personal activities of daily living improves recovery for patients after stroke. Design Systematic review and meta-analysis. Data sources The Cochrane stroke group trials register, the Cochrane central register of controlled trials, Medline, Embase, CINAHL, PsycLIT, AMED, Wilson Social Sciences Abstracts, Science Citation Index, Social Science Citation, Arts and Humanities Citation Index, Dissertations Abstracts register, Occupational Therapy Research Index, scanning reference lists, personal communication with authors, and hand searching. Review methods Trials were included if they evaluated the effect of occupational therapy focused on practice of personal activities of daily living or where performance in such activities was the target of the occupational therapy intervention in a stroke population. Original data were sought from trialists. Two reviewers independently reviewed each trial for methodological quality. Disagreements were resolved by consensus. Results Nine randomised controlled trials including 1258 participants met the inclusion criteria. Occupational therapy delivered to patients after stroke and targeted towards personal activities of daily living increased performance scores (standardised mean difference 0.18, 95% confidence interval 0.04 to 0.32, P=0.01) and reduced the risk of poor outcome (death, deterioration or dependency in personal activities of daily living) (odds ratio 0.67, 95% confidence interval 0.51 to 0.87, P=0.003). For every 100 people who received occupational therapy focused on personal activities of daily living, 11 (95% confidence interval 7 to 30) would be spared a poor outcome. Conclusions Occupational therapy focused on improving personal activities of daily living after stroke can improve performance and reduce the risk of deterioration in these abilities. Focused occupational therapy should be available to everyone who has had a stroke. PMID

  7. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention.

    PubMed

    McCusker, Jane; Lambert, Sylvie D; Cole, Martin G; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E; Belzile, Eric

    2016-12-01

    In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of self-care tools; and to examine the effects of a depression self-care coaching intervention on these two outcomes. Design/Study Setting. A secondary analysis of activation and self-efficacy data collected as part of a randomized trial to compare the effects of a telephone-based coached depression self-care intervention with a noncoached intervention. Activation (Patient Activation Measure) was measured at baseline and 6 months. Depression self-care self-efficacy was assessed at baseline, at 3 months, and at 6 months. In multivariable cross-sectional analyses (n = 215), activation and/or self-efficacy were associated with language, birthplace, better physical and mental health, individual exercise, specialist visits, and antidepressant nonuse. In longitudinal analyses (n = 158), an increase in activation was associated with increased medication adherence; an increase in self-efficacy was associated with use of cognitive self-care strategies and increases in social and solitary activities. There were significant improvements from baseline to 6 months in activation and self-efficacy scores both among coached and noncoached groups. The self-care coaching intervention did not affect 6-month activation or self-efficacy but was associated with quicker improvement in self-efficacy. Overall, the results for activation and self-efficacy were similar, although self-efficacy correlated more consistently than activation with depression-specific behaviors and was responsive to a depression self-care coaching intervention. © 2016 Society for Public Health Education.

  8. A self-controlled trial to evaluate the use of active hearing defenders in the engine rooms of operational naval vessels.

    PubMed

    Ong, M; Choo, J T L; Low, E

    2004-02-01

    Active Hearing Defenders are established hearing protectors with in-built electro-acoustics that shut-off ambient noise while allowing effective communication between users. A blinded, self-controlled trial was conducted among naval servicemen to compare the effectiveness of two types of active hearing defenders (Howard-Leight Thunder TM and COM-55) in relation to passive hearing defenders in an operational environment. Subjects felt that the active hearing defenders were more comfortable, durable, and that the active hearing defenders helped them work better. When subjects were tested with a speech discrimination battery (Central Institute of the Deaf, Spondee Word lists), there was a significant difference (p value of 0.04, using the Kruskall-Wallis ANOVA test) between the two active and the passive defenders. However, no significant difference was found between the two types of active hearing defenders. Active hearing defenders are an acceptable and efficacious means of hearing protection in noisy environments.

  9. Trial of infographics in Northern Ireland (TINI): Preliminary evaluation and results of a randomized controlled trial comparing infographics with text.

    PubMed

    McCrorie, Alan David; Chen, Jingwen Jessica; Weller, Ross; McGlade, Kieran John; Donnelly, Conan

    2018-06-01

    Infographics represent a potential means of improving public knowledge about cancer. However, there is little experimental evidence of their efficacy. This preliminary study investigates whether infographics are superior to text for the communication of information about cancer risk in old age via a three armed randomized controlled trial. Trial involved allocation concealment and block randomization of 30 male participants aged over 50 to receive text information (control) or one of two infographics (interventions). Participants who viewed an infographic were more likely to know the correct association between cancer risk and old age compared with those viewing text information (risk ratio = 3.0, 95% confidence interval 0.82-10.90). Participants had limited understanding of the phrases "cancer incidence" and "cancer prevalence" but good understanding of the phrases "cancer risk factor" and "cancer stage." Possession of good numerical skills appears to be a key determinant of ability to extract meaning from statistical information provided; regardless of format. Initial results suggest icon array infographics may be more effective communication mediums than text but further study with more participants and an updated infographic is necessary to confirm this finding. ISRCTN33951209.

  10. Global women's health: current clinical trials in low- and middle-income countries.

    PubMed

    Merriel, A; Harb, H M; Williams, H; Lilford, R; Coomarasamy, A

    2015-01-01

    Clinical trials in low- and middle-income countries (LMICs) are necessary to develop evidence-based approaches to improve women's health. Understanding what research is currently being conducted will allow the identification of research gaps, avoidance of duplication, planning of future studies, collaboration amongst research groups, and geographical targeting for research investments. To provide an overview of active women's health trials in LMICs. The World Health Organization's International Clinical Trials Registry Platform was searched for trials registered between 1 April 2012 and 31 March 2014. Selected trials were randomised, conducted in LMICs, active, and with a women's health intervention or a significant outcome for the woman. Two reviewers extracted data. Analysis included geographical spread, speciality areas, pre-enrolment registration, study size, and funders. Of the 8966 records, 509 were eligible for inclusion. Gynaecology trials made up 57% of the research, whereas the remaining 43% of trials were in obstetrics. Research activity focused on fertility (17%), the antenatal period (15%), benign gynaecology (14%), intrapartum care (9%), and pre-invasive disease and cancers (8%). The majority of trials (84%) took place in middle-income countries (MICs). In low-income countries (LICs) 83% of research investigated obstetrics, and in MICs 60% of research investigated gynaecology. Most trials (80%) had a sample size of 500 or fewer participants. The median size of trials in LICs was 815 compared with 128 in MICs. Pre-enrolment registration occurred in 54% of trials. The majority (62%) of trials were funded locally. Many LMICs are active in women's health research. The majority of registered trials are located in MICs; however, the trials in LICs are often larger. The focus of research in MICs may be driven by local priorities and funding, with fertility being highly researched. In LICs, pregnancy is the focus, perhaps reflecting the international

  11. Integrating Tobacco Treatment into Cancer Care: Study Protocol for a Randomized Controlled Comparative Effectiveness Trial

    PubMed Central

    Park, Elyse R.; Ostroff, Jamie S.; Perez, Giselle K.; Hyland, Kelly A.; Rigotti, Nancy A.; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R.; Levy, Douglas E.; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O’Brien, Maureen; de León-Sanchez, Suhana; Will Whitlock, C.

    2016-01-01

    Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. PMID:27444428

  12. Mortality in two recent reports of clinical trials on patients with congestive heart failure compared with mortality in three previous clinical trials.

    PubMed

    Singer, R B

    2000-01-01

    Several clinical trials of drug treatment of patients with congestive heart failure (CHF) have previously been reported as Mortality Abstracts in the Journal of Insurance Medicine. Results are presented here for two similar clinical trials reported in September 1999 and compared with the previous results. In a recent international multicenter clinical trial, excess mortality in terms of excess death rates (EDRs) was reduced from 195 per 1000 per year in the placebo group to 139 in the group treated with Spironolactone. There was no significant reduction in the Danish multicenter study of Dofetilide to convert the atrial fibrillation (AF) to a normal rhythm in the 25% of the CHF patients who had AF (EDR was 224 in the placebo group and 216 in the Dofetilide group). In both of these studies, there were more patients with severe CHF than in the previous studies and the EDR values were higher. Results from the Danish study by severity according to the New York Heart Association (NYHA) classification show a progressive increase in EDR from 173 in class 2 to 237 in class 3 to 392 in class 4. Excess mortality in symptomatic CHF is far outside the issue limits for individual life insurance, but these results are of potential utility for the underwriting of such cases for structured settlement annuities.

  13. Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information.

    PubMed

    Acolet, Dominique; Allen, Elizabeth; Houston, Rosie; Wilkinson, Andrew R; Costeloe, Kate; Elbourne, Diana

    2011-11-01

    Research findings are not rapidly or fully implemented into policies and practice in care. To assess whether an 'active' strategy was more likely to lead to changes in policy and practice in preterm baby care than traditional information dissemination. Cluster randomised trial. 180 neonatal units (87 active, 93 control) in England; clinicians from active arm units; babies born <27 weeks gestation. CONTROL ARM: Dissemination of research report; slides; information about newborn care position statement. ACTIVE ARM: As above plus offer to become 'regional 'champion' (attend two workshops, support clinicians to implement research evidence regionally), or attend one workshop, promote implementation of research evidence locally. timing of surfactant administration; admission temperature; staffing of resuscitation team present at birth. 48/87 Lead clinicians in the active arm attended one or both workshops. There was no evidence of difference in post-intervention policies between trial arms. Practice outcomes based on babies in the active (169) and control arms (186), in 45 and 49 neonatal units respectively, showed active arm babies were more likely to have been given surfactant on labour ward (RR=1.30; 95% CI 0.99 to 1.70); p=0.06); to have a higher temperature on admission to neonatal intensive care unit (mean difference=0.29(o)C; 95% CI 0.22 to 0.55; p=0.03); and to have had the baby's trunk delivered into a plastic bag (RR=1.27; 95% CI 1.01 to 1.60; p=0.04) than the control group. The effect on having an 'ideal' resuscitation team at birth was in the same direction of benefit for the active arm (RR=1.18; 95% CI 0.97 to 1.43; p=0.09). The costs of the intervention were modest. This is the first trial to evaluate methods for transferring information from neonatal research into local policies and practice in England. An active approach to research dissemination is both feasible and cost-effective. Current controlled trials ISRCTN89683698.

  14. A cluster-randomised controlled trial to promote physical activity in adolescents: the Raising Awareness of Physical Activity (RAW-PA) Study.

    PubMed

    Ridgers, Nicola D; Timperio, Anna; Brown, Helen; Ball, Kylie; Macfarlane, Susie; Lai, Samuel K; Richards, Kara; Ngan, Winsfred; Salmon, Jo

    2017-01-04

    Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA) Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents' daily physical activity levels. RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex) and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13-14 years). Participants' moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity) will also be collected. To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents' physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy. Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016.

  15. Year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity.

    PubMed

    Van Hoye, Karen; Wijtzes, Anne I; Lefevre, Johan; De Baere, Stijn; Boen, Filip

    2018-04-12

    This follow-up study investigated the year-round effects of a four-week randomized controlled trial using different types of feedback on employees' physical activity, including a need-supportive coach intervention. Participants (n = 227) were randomly assigned to a Minimal Intervention Group (MIG; no feedback), a Pedometer Group (PG; feedback on daily steps only), a Display Group (DG; feedback on daily steps, on daily moderate-to-vigorous physical activity [MVPA] and on total energy expenditure [EE]), or a Coaching Group (CoachG; same as DG with need supportive coaching). Daily physical activity level (PAL; Metabolic Equivalent of Task [MET]), number of daily steps, daily minutes of moderate to vigorous physical activity (MVPA), active daily EE (EE > 3 METs) and total daily EE were measured at five time points: before the start of the 4-week intervention, one week after the intervention, and 3, 6, and 12 months after the intervention. For minutes of MVPA, MIG showed higher mean change scores compared with the DG. For steps and daily minutes of MVPA, significantly lower mean change scores emerged for MIG compared with the PG. Participants of the CoachG showed significantly higher change scores in PAL, steps, minutes of MVPA, active EE, total EE compared with the MIG. As hypothesized, participants of the CoachG had significantly higher mean change scores in PAL and total EE compared with groups that only received feedback. However, no significant differences were found for steps, minutes of MVPA and active EE between CoachG and PG. Receiving additional need-supportive coaching resulted in a higher PAL and active EE compared with measurement (display) feedback only. These findings suggest to combine feedback on physical activity with personal coaching in order to facilitate long-term behavioral change. When it comes to increasing steps, minutes of MVPA or active EE, a pedometer constitutes a sufficient tool. Clinical Trails.gov NCT01432327 . Date registered

  16. Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial).

    PubMed

    Crawley, Esther; Mills, Nicola; Hollingworth, Will; Deans, Zuzana; Sterne, Jonathan A; Donovan, Jenny L; Beasant, Lucy; Montgomery, Alan

    2013-12-26

    Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and potentially serious condition with a limited evidence base for treatment. Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence (NICE) including cognitive behavioural therapy, graded exercise therapy and activity management. The Lightning Process (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness. This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale). This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC. Current Controlled Trials ISRCTN81456207 (31 July 2012).

  17. The effects of honey compared to silver sulfadiazine for the treatment of burns: A systematic review of randomized controlled trials.

    PubMed

    Aziz, Zoriah; Abdul Rasool Hassan, Bassam

    2017-02-01

    Evidence from animal studies and trials suggests that honey may accelerate wound healing. The objective of this review was to assess the effects of honey compared with silver dressings on the healing of burn wounds. Relevant databases for randomized controlled trials (RCTs) of honey compared with silver sulfadiazine (SSD) were searched. The quality of the selected trials was assessed using the Cochrane Risk of Bias Assessment Tool. The primary endpoints considered were wound healing time and the number of infected wounds rendered sterile. Nine RCTs met the inclusion criteria. Based on moderate quality evidence there was a statistically significant difference between the two groups, favoring honey in healing time (MD -5.76days, 95% CI -8.14 to -3.39) and the proportions of infected wounds rendered sterile (RR 2.59; 95% CI 1.58-2.88). The available evidence suggests that honey dressings promote better wound healing than silver sulfadiazine for burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  18. A randomised controlled trial of active chronic otitis media comparing courses of eardrops versus one-off topical treatments suitable for primary, secondary and tertiary healthcare settings.

    PubMed

    Loock, J W

    2012-08-01

    Primary: to compare one-off administration of boric acid powder with courses of 1% acetic acid and ciprofloxacin eardrops in treating active chronic otitis media. Secondary: to evaluate the effectiveness of Quadriderm® cream in resistant active chronic otitis media; and to document side effects of these treatments, especially hearing loss. Randomised controlled trial. Outpatient department of a tertiary ENT unit. Hundred and fifty-nine patients over 6 years old with active chronic mucosal (without cholesteatoma) otitis media randomised to receive one of the three primary agents. All techniques employed were suitable for primary healthcare givers as well as specialists. After confirming eligibility, patients were randomly allocated to treatment. All ears underwent toilet with irrigation using clean water, a syringe and ambient light, with or without dry mopping, until the perforation was visible. The randomised solution was flushed through the middle ear and eustachian tube using a 'tragal pump' technique: saline was used as the solution for flushing in the boric acid powder arm. Patients allocated topical ear medication were given a bottle of eardrops to administer (six drops twice daily, 'pumped in') until finished. Those allocated boric acid powder had the external ear canals filled as a one-off treatment. Patients were followed up monthly thereafter. Primary: Dry (inactive) middle ears as assessed by the doctor. Secondary: Patient assessment of success; microbiologic culture and sensitivity; audiologic changes because of treatment; complications of treatment; costs of therapies. Ciprofloxacin eardrops and boric acid powder were statistically superior to 1% acetic acid eardrops in rendering active chronic otitis media inactive (73% dry ears for ciprofloxacin; 67% for boric acid powder; and 24% for acetic acid). There was no difference between the success rates of ciprofloxacin eardrops and boric acid powder. Quadriderm cream was effective in 85% of patients

  19. Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.

    PubMed

    Gold, Rachel; Hollombe, Celine; Bunce, Arwen; Nelson, Christine; Davis, James V; Cowburn, Stuart; Perrin, Nancy; DeVoe, Jennifer; Mossman, Ned; Boles, Bruce; Horberg, Michael; Dearing, James W; Jaworski, Victoria; Cohen, Deborah; Smith, David

    2015-10-16

    Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices. Having a better understanding of how different

  20. Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

    PubMed Central

    McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

    2014-01-01

    Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

  1. SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings

    PubMed Central

    Burke, Lora E.; Styn, Mindi A.; Glanz, Karen; Ewing, Linda J.; Elci, Okan U.; Conroy, Margaret B.; Sereika, Susan M.; Acharya, Sushama D.; Music, Edvin; Keating, Alison L.; Sevick, Mary Ann

    2009-01-01

    Background The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. Methods The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). Results We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. Conclusions To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component. PMID:19665588

  2. More outcomes than trials: a call for consistent data collection across stroke rehabilitation trials.

    PubMed

    Ali, M; English, C; Bernhardt, J; Sunnerhagen, K S; Brady, M

    2013-01-01

    Stroke survivors experience complex combinations of impairments, activity limitations, and participation restrictions. The essential components of stroke rehabilitation remain elusive. Determining efficacy in randomized controlled trials (RCTs) is challenging; there is no commonly agreed primary outcome measure for rehabilitation trials. Clinical guidelines depend on proof of efficacy in RCTs and meta-analyses. However, diverse trial aims, differing methods, inconsistent data collection, and use of multiple assessment tools hinder comparability across trials. Consistent data collection in acute stroke trials has facilitated meta-analyses to inform trial design and clinical practice. With few exceptions, inconsistent data collection has hindered similar progress in stroke rehabilitation research. There is an urgent need for the routine collection of a core dataset of common variables in rehabilitation trials. The European Stroke Organisation Outcomes Working Group, the National Institutes of Neurological Disorders and Stroke Common Data Elements project, and the Collaborative Stroke Audit and Research project have called for consistency in data collection in stroke trials. Standardizing data collection can decrease study start up times, facilitate data sharing, and inform clinical guidelines. Although achieving consensus on which outcome measures to use in stroke rehabilitation trials is a considerable task, perhaps a feasible starting point is to achieve consistency in the collection of data on demography, stroke severity, and stroke onset to inclusion times. Longer term goals could include the development of a consensus process to establish the core dataset. This should be endorsed by researchers, funders, and journal editors in order to facilitate sustainable change. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  3. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial.

    PubMed

    Sydes, Matthew R; Parmar, Mahesh K B; Mason, Malcolm D; Clarke, Noel W; Amos, Claire; Anderson, John; de Bono, Johann; Dearnaley, David P; Dwyer, John; Green, Charlene; Jovic, Gordana; Ritchie, Alastair W S; Russell, J Martin; Sanders, Karen; Thalmann, George; James, Nicholas D

    2012-09-15

    Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) is a randomized controlled trial that follows a novel multi-arm, multi-stage (MAMS) design. We describe methodological and practical issues arising with (1) stopping recruitment to research arms following a pre-planned intermediate analysis and (2) adding a new research arm during the trial. STAMPEDE recruits men who have locally advanced or metastatic prostate cancer who are starting standard long-term hormone therapy. Originally there were five research and one control arms, each undergoing a pilot stage (focus: safety, feasibility), three intermediate 'activity' stages (focus: failure-free survival), and a final 'efficacy' stage (focus: overall survival). Lack-of-sufficient-activity guidelines support the pairwise interim comparisons of each research arm against the control arm; these pre-defined activity cut-off becomes increasingly stringent over the stages. Accrual of further patients continues to the control arm and to those research arms showing activity and an acceptable safety profile. The design facilitates adding new research arms should sufficiently interesting agents emerge. These new arms are compared only to contemporaneously recruited control arm patients using the same intermediate guidelines in a time-delayed manner. The addition of new research arms is subject to adequate recruitment rates to support the overall trial aims. (1) Stopping Existing Therapy: After the second intermediate activity analysis, recruitment was discontinued to two research arms for lack-of-sufficient activity. Detailed preparations meant that changes were implemented swiftly at 100 international centers and recruitment continued seamlessly into Activity Stage III with 3 remaining research arms and the control arm. Further regulatory and ethical approvals were not required because this was already included in the initial trial design.(2) Adding New Therapy: An application to

  4. Effectiveness of a Worksite Social & Physical Environment Intervention on Need for Recovery, Physical Activity and Relaxation; Results of a Randomized Controlled Trial

    PubMed Central

    Coffeng, Jennifer K.; Boot, Cécile R. L.; Duijts, Saskia F. A.; Twisk, Jos W. R.; van Mechelen, Willem; Hendriksen, Ingrid J. M.

    2014-01-01

    Objective To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery (i.e., early symptoms of work-related mental and physical fatigue), physical activity and relaxation. Also, the effectiveness of the separate interventions was investigated. Methods In this 2×2 factorial design study, 412 office employees from a financial service provider participated. Participants were allocated to the combined social and physical intervention, to the social intervention only, to the physical intervention only or to the control group. The primary outcome measure was need for recovery. Secondary outcomes were work-related stress (i.e., exhaustion, detachment and relaxation), small breaks, physical activity (i.e., stair climbing, active commuting, sport activities, light/moderate/vigorous physical activity) and sedentary behavior. Outcomes were measured by questionnaires at baseline, 6 and 12 months follow-up. Multilevel analyses were performed to investigate the effects of the three interventions. Results In all intervention groups, a non-significant reduction was found in need for recovery. In the combined intervention (n = 92), exhaustion and vigorous physical activities decreased significantly, and small breaks at work and active commuting increased significantly compared to the control group. The social intervention (n = 118) showed a significant reduction in exhaustion, sedentary behavior at work and a significant increase in small breaks at work and leisure activities. In the physical intervention (n = 96), stair climbing at work and active commuting significantly increased, and sedentary behavior at work decreased significantly compared to the control group. Conclusion None of the interventions was effective in improving the need for recovery. It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery. Furthermore, the intervention

  5. Comparing community and specialty provider-based recruitment in a randomized clinical trial: clinical trial in fecal incontinence.

    PubMed

    Whitebird, Robin R; Bliss, Donna Zimmaro; Savik, Kay; Lowry, Ann; Jung, Hans-Joachim G

    2010-12-01

    Recruitment of participants to clinical trials remains a significant challenge, especially for research addressing topics of a sensitive nature such as fecal incontinence (FI). In the Fiber Study, a randomized controlled trial on symptom management for FI, we successfully enrolled 189 community-living adults through collaborations with specialty-based and community-based settings, each employing methods tailored to the organizational characteristics of their site. Results show that using the two settings increased racial and ethnic diversity of the sample and inclusion of informal caregivers. There were no differential effects on enrollment, final eligibility, or completion of protocol by site. Strategic collaborations with complementary sites can achieve sample recruitment goals for clinical trials on topics that are sensitive or known to be underreported. Copyright © 2010 Wiley Periodicals, Inc.

  6. Engineering Online and In-person Social Networks for Physical Activity: A Randomized Trial

    PubMed Central

    Rovniak, Liza S.; Kong, Lan; Hovell, Melbourne F.; Ding, Ding; Sallis, James F.; Ray, Chester A.; Kraschnewski, Jennifer L.; Matthews, Stephen A.; Kiser, Elizabeth; Chinchilli, Vernon M.; George, Daniel R.; Sciamanna, Christopher N.

    2016-01-01

    Background Social networks can influence physical activity, but little is known about how best to engineer online and in-person social networks to increase activity. Purpose To conduct a randomized trial based on the Social Networks for Activity Promotion model to assess the incremental contributions of different procedures for building social networks on objectively-measured outcomes. Methods Physically inactive adults (n = 308, age, 50.3 (SD = 8.3) years, 38.3% male, 83.4% overweight/obese) were randomized to 1 of 3 groups. The Promotion group evaluated the effects of weekly emailed tips emphasizing social network interactions for walking (e.g., encouragement, informational support); the Activity group evaluated the incremental effect of adding an evidence-based online fitness walking intervention to the weekly tips; and the Social Networks group evaluated the additional incremental effect of providing access to an online networking site for walking, and prompting walking/activity across diverse settings. The primary outcome was mean change in accelerometer-measured moderate-to-vigorous physical activity (MVPA), assessed at 3 and 9 months from baseline. Results Participants increased their MVPA by 21.0 mins/week, 95% CI [5.9, 36.1], p = .005, at 3 months, and this change was sustained at 9 months, with no between-group differences. Conclusions Although the structure of procedures for targeting social networks varied across intervention groups, the functional effect of these procedures on physical activity was similar. Future research should evaluate if more powerful reinforcers improve the effects of social network interventions. Trial Registration Number NCT01142804 PMID:27405724

  7. Can Pacing Be Regulated by Post-Activation Potentiation? Insights from a Self-Paced 30 km Trial in Half-Marathon Runners

    PubMed Central

    Del Rosso, Sebastián; Barros, Edilberto; Tonello, Laís; Oliveira-Silva, Iransé; Behm, David G.; Foster, Carl; Boullosa, Daniel A.

    2016-01-01

    Purpose Given the co-existence of post-activation potentiation (PAP) and fatigue within muscle, it is not known whether PAP could influence performance and pacing during distance running by moderating fatigue. The aim of this study was to assess the influence of PAP on pacing, jumping and other physiological measures during a self-paced 30 km trial. Methods Eleven male endurance-trained runners (half-marathon runners) volunteered to participate in this study. Runners participated in a multi-stage 30 km trial. Before the trial started, determination of baseline blood lactate (bLa) and countermovement jump (CMJ) height was performed. The self-paced 30 km trial consisted of 6 × 5 km splits. At the end of each 5 km split (60 s break), data on time to complete the split, CMJ height, Rating of Perceived Exertion (RPE) and blood lactate were collected while heart rate was continuously monitored. Results There was a significant decrease in speed (e.g. positive pacing strategy after the 4th split, p<0.05) with a progressive increase in RPE throughout the trial. Compared with baseline, CMJ height was significantly (p<0.05) greater than baseline and was maintained until the end of the trial with an increase after the 5th split, concomitant with a significant reduction in speed and an increase in RPE. Significant correlations were found between ΔCMJ and ΔSPEED (r = 0.77 to 0.87, p<0.05) at different time points as well as between RPE and speed (r = -0.61 to -0.82, p<0.05). Conclusion Our results indicates that fatigue and potentiation co-exist during long lasting endurance events, and that the observed increase in jump performance towards the end of the trial could be reflecting a greater potentiation potentially perhaps counteracting the effects of fatigue and preventing further reductions in speed. PMID:26934357

  8. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery.

    PubMed

    Wang, Z G; Wang, Q; Wang, W J; Qin, H L

    2010-03-01

    Preoperative oral carbohydrate (OCH) reduces postoperative insulin resistance (PIR). This randomized trial investigated whether this effect is related to insulin-induced activation of the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (PKB) signalling pathway. Patients with colorectal cancer scheduled for elective open resection were randomly assigned to preoperative OCH, fasting or placebo. Preoperative general well-being, insulin resistance before and immediately after surgery, and postoperative expression of PI3K, PKB, protein tyrosine kinase (PTK) and glucose transporter 4 (GLUT4) in rectus abdominis muscle were evaluated. Patient and operative characteristics did not differ between groups. Subjective well-being was significantly better in OCH and placebo groups than in the fasting group, primarily because of reduced thirst (P = 0.005) and hunger (P = 0.041). PIR was significantly greater in fasting and placebo groups (P < 0.010). By the end of surgery, muscle PTK activity as well as PI3K and PKB levels were significantly increased in the OCH group compared with values in fasting and placebo groups (P < 0.050), but GLUT4 expression was unaffected. PIR involves the PI3K/PKB signalling pathway. Preoperative OCH intake improves preoperative subjective feelings of hunger and thirst compared with fasting, while attenuating PIR by stimulation of the PI3K/PKB pathway. (c) 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

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

    PubMed

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

    2008-07-01

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

  10. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

    PubMed

    Mackeen, A Dhanya; Durie, Danielle E; Lin, Monique; Huls, Christopher K; Qureshey, Emma; Paglia, Michael J; Sun, Haiyan; Sciscione, Anthony

    2018-01-01

    To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes. This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than 2 cm or 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat. We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied. In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection. ClinicalTrials.gov, NCT01973036.

  11. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    PubMed

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  12. Increased brain connectivity and activation after cognitive rehabilitation in Parkinson's disease: a randomized controlled trial.

    PubMed

    Díez-Cirarda, María; Ojeda, Natalia; Peña, Javier; Cabrera-Zubizarreta, Alberto; Lucas-Jiménez, Olaia; Gómez-Esteban, Juan Carlos; Gómez-Beldarrain, Maria Ángeles; Ibarretxe-Bilbao, Naroa

    2017-12-01

    Cognitive rehabilitation programs have demonstrated efficacy in improving cognitive functions in Parkinson's disease (PD), but little is known about cerebral changes associated with an integrative cognitive rehabilitation in PD. To assess structural and functional cerebral changes in PD patients, after attending a three-month integrative cognitive rehabilitation program (REHACOP). Forty-four PD patients were randomly divided into REHACOP group (cognitive rehabilitation) and a control group (occupational therapy). T1-weighted, diffusion weighted and functional magnetic resonance images (fMRI) during resting-state and during a memory paradigm (with learning and recognition tasks) were acquired at pre-treatment and post-treatment. Cerebral changes were assessed with repeated measures ANOVA 2 × 2 for group x time interaction. During resting-state fMRI, the REHACOP group showed significantly increased brain connectivity between the left inferior temporal lobe and the bilateral dorsolateral prefrontal cortex compared to the control group. Moreover, during the recognition fMRI task, the REHACOP group showed significantly increased brain activation in the left middle temporal area compared to the control group. During the learning fMRI task, the REHACOP group showed increased brain activation in the left inferior frontal lobe at post-treatment compared to pre-treatment. No significant structural changes were found between pre- and post-treatment. Finally, the REHACOP group showed significant and positive correlations between the brain connectivity and activation and the cognitive performance at post-treatment. This randomized controlled trial suggests that an integrative cognitive rehabilitation program can produce significant functional cerebral changes in PD patients and adds evidence to the efficacy of cognitive rehabilitation programs in the therapeutic approach for PD.

  13. Fall prevention with supplemental and active forms of vitamin D: a meta-analysis of randomised controlled trials

    PubMed Central

    Dawson-Hughes, B; Staehelin, H B; Orav, J E; Stuck, A E; Theiler, R; Wong, J B; Egli, A; Kiel, D P; Henschkowski, J

    2009-01-01

    Objective To test the efficacy of supplemental vitamin D and active forms of vitamin D with or without calcium in preventing falls among older individuals. Data sources We searched Medline, the Cochrane central register of controlled trials, BIOSIS, and Embase up to August 2008 for relevant articles. Further studies were identified by consulting clinical experts, bibliographies, and abstracts. We contacted authors for additional data when necessary. Review methods Only double blind randomised controlled trials of older individuals (mean age 65 years or older) receiving a defined oral dose of supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)) or an active form of vitamin D (1α-hydroxyvitamin D3 (1α-hydroxycalciferol) or 1,25-dihydroxyvitamin D3 (1,25-dihydroxycholecalciferol)) and with sufficiently specified fall assessment were considered for inclusion. Results Eight randomised controlled trials (n=2426) of supplemental vitamin D met our inclusion criteria. Heterogeneity among trials was observed for dose of vitamin D (700-1000 IU/day v 200-600 IU/day; P=0.02) and achieved 25-hydroxyvitamin D3 concentration (25(OH)D concentration: <60 nmol/l v ≥60 nmol/l; P=0.005). High dose supplemental vitamin D reduced fall risk by 19% (pooled relative risk (RR) 0.81, 95% CI 0.71 to 0.92; n=1921 from seven trials), whereas achieved serum 25(OH)D concentrations of 60 nmol/l or more resulted in a 23% fall reduction (pooled RR 0.77, 95% CI 0.65 to 0.90). Falls were not notably reduced by low dose supplemental vitamin D (pooled RR 1.10, 95% CI 0.89 to 1.35; n=505 from two trials) or by achieved serum 25-hydroxyvitamin D concentrations of less than 60 nmol/l (pooled RR 1.35, 95% CI 0.98 to 1.84). Two randomised controlled trials (n=624) of active forms of vitamin D met our inclusion criteria. Active forms of vitamin D reduced fall risk by 22% (pooled RR 0.78, 95% CI 0.64 to 0.94). Conclusions Supplemental vitamin D in a dose of 700-1000 IU a day

  14. Differential sensory fMRI signatures in autism and schizophrenia: Analysis of amplitude and trial-to-trial variability.

    PubMed

    Haigh, Sarah M; Gupta, Akshat; Barb, Scott M; Glass, Summer A F; Minshew, Nancy J; Dinstein, Ilan; Heeger, David J; Eack, Shaun M; Behrmann, Marlene

    2016-08-01

    Autism and schizophrenia share multiple phenotypic and genotypic markers, and there is ongoing debate regarding the relationship of these two disorders. To examine whether cortical dynamics are similar across these disorders, we directly compared fMRI responses to visual, somatosensory and auditory stimuli in adults with autism (N=15), with schizophrenia (N=15), and matched controls (N=15). All participants completed a one-back letter detection task presented at fixation (to control attention) while task-irrelevant sensory stimulation was delivered to the different modalities. We focused specifically on the response amplitudes and the variability in sensory fMRI responses of the two groups, given the evidence of greater trial-to-trial variability in adults with autism. Both autism and schizophrenia individuals showed weaker signal-to-noise ratios (SNR) in sensory-evoked responses compared to controls (d>0.42), but for different reasons. For the autism group, the fMRI response amplitudes were indistinguishable from controls but were more variable trial-to-trial (d=0.47). For the schizophrenia group, response amplitudes were smaller compared to autism (d=0.44) and control groups (d=0.74), but were not significantly more variable (d<0.29). These differential group profiles suggest (1) that greater trial-to-trial variability in cortical responses may be specific to autism and is not a defining characteristic of schizophrenia, and (2) that blunted response amplitudes may be characteristic of schizophrenia. The relationship between the amplitude and the variability of cortical activity might serve as a specific signature differentiating these neurodevelopmental disorders. Identifying the neural basis of these responses and their relationship to the underlying genetic bases may substantially enlighten the understanding of both disorders. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

    PubMed

    Molt, Mats; Toksvig-Larsen, Sören

    2014-10-01

    The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.

    PubMed

    Smolen, Josef S; Choe, Jung-Yoon; Prodanovic, Nenad; Niebrzydowski, Jaroslaw; Staykov, Ivan; Dokoupilova, Eva; Baranauskaite, Asta; Yatsyshyn, Roman; Mekic, Mevludin; Porawska, Wieskawa; Ciferska, Hana; Jedrychowicz-Rosiak, Krystyna; Zielinska, Agnieszka; Choi, Jasmine; Rho, Young Hee

    2017-10-01

    SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37). © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  17. Clinical Trials

    MedlinePlus

    Clinical trials are research studies that test how well new medical approaches work in people. Each study ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to ...

  18. Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation

  19. The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics

    PubMed Central

    2013-01-01

    Background The utility of advanced prehospital interventions for severe blunt traumatic brain injury (BTI) remains controversial. Of all trauma patient subgroups it has been anticipated that this patient group would most benefit from advanced prehospital interventions as hypoxia and hypotension have been demonstrated to be associated with poor outcomes and these factors may be amenable to prehospital intervention. Supporting evidence is largely lacking however. In particular the efficacy of early anaesthesia/muscle relaxant assisted intubation has proved difficult to substantiate. Methods This article describes the design and protocol of the Head Injury Retrieval Trial (HIRT) which is a randomised controlled single centre trial of physician prehospital care (delivering advanced interventions such as rapid sequence intubation and blood transfusion) in addition to paramedic care for severe blunt TBI compared with paramedic care alone. Results Primary endpoint is Glasgow Outcome Scale score at six months post injury. Issues with trial integrity resulting from drop ins from standard care to the treatment arm as the result of policy changes by the local ambulance system are discussed. Conclusion This randomised controlled trial will contribute to the evaluation of the efficacy of advance prehospital interventions in severe blunt TBI. Trial Registration ClinicalTrials.gov: NCT00112398 PMID:24034628

  20. What is the effect of a combined physical activity and fall prevention intervention enhanced with health coaching and pedometers on older adults' physical activity levels and mobility-related goals? Study protocol for a randomised controlled trial.

    PubMed

    Tiedemann, Anne; Paul, Serene; Ramsay, Elisabeth; O'Rourke, Sandra D; Chamberlain, Kathryn; Kirkham, Catherine; Merom, Dafna; Fairhall, Nicola; Oliveira, Juliana S; Hassett, Leanne; Sherrington, Catherine

    2015-05-09

    Physical inactivity and falls in older people are important public health problems. Health conditions that could be ameliorated with physical activity are particularly common in older people. One in three people aged 65 years and over fall at least once annually, often resulting in significant injuries and ongoing disability. These problems need to be urgently addressed as the population proportion of older people is rapidly rising. This trial aims to establish the impact of a combined physical activity and fall prevention intervention compared to an advice brochure on objectively measured physical activity participation and mobility-related goal attainment among people aged 60+. A randomised controlled trial involving 130 consenting community-dwelling older people will be conducted. Participants will be individually randomised to a control group (n = 65) and receive a fall prevention brochure, or to an intervention group (n = 65) and receive the brochure plus physical activity promotion and fall prevention intervention enhanced with health coaching and a pedometer. Primary outcomes will be objectively measured physical activity and mobility-related goal attainment, measured at both six and 12 months post randomisation. Secondary outcomes will include: falls, the proportion of people meeting the physical activity guidelines, quality of life, fear of falling, mood, and mobility limitation. Barriers and enablers to physical activity participation will be measured 6 months after randomisation. General linear models will be used to assess the effect of group allocation on the continuously-scored primary and secondary outcome measures, after adjusting for baseline scores. Between-group differences in goal attainment (primary outcome) will be analysed with ordinal regression. The number of falls per person-year will be analysed using negative binomial regression models to estimate the between-group difference in fall rates after one year (secondary outcome). Modified

  1. A multicentre randomised, 1-year comparative effectiveness, parallel-group trial protocol of a physical therapy approach compared to corticosteroid injections

    PubMed Central

    Deyle, Gail D; Gill, Norman W; Rhon, Daniel I; Allen, Chris S; Allison, Stephen C; Hando, Ben R; Petersen, Evan J; Dusenberry, Douglas I; Bellamy, Nicholas

    2016-01-01

    Introduction Corticosteroid injections (CSIs) are commonly used as an initial or a primary intervention for knee osteoarthritis (OA). Consistent evidence indicates CSIs offer symptom relief with conflicting reports regarding long-term efficacy. Physical therapy (PT) offers a non-invasive alternative. There is moderate evidence suggesting short-term and long-term symptom relief and functional improvement with PT interventions. Patients with knee OA are more commonly prescribed CSI than PT prior to total joint replacement. UnitedHealthcare and Military Health System data show substantially more total knee replacement patients receive preoperative CSI than PT. There are no studies comparing CSI to a PT approach in individuals with knee OA. The primary objective of this study is to compare the effectiveness of CSI to PT in individuals with knee OA at 1, 2 and 12 months. Methods and analysis We plan to recruit 156 participants meeting established knee OA criteria. Following informed consent, participants will be randomised to receive either CSI or PT. All participants will receive instruction on recommended exercise and weight control strategies plus usual medical care. The CSI intervention consisting of 3 injections and the PT intervention consisting of 8–12 sessions will be spaced over 12 months. Measures of the dependent variables (DVs) will occur at baseline, 4 weeks, 8 weeks, 6 months and 12 months post enrolment. This pragmatic, randomised clinical trial will be a mixed-model 2×5 factorial design. The independent variables are treatment (CSI and PT) and time with five levels from baseline to 1 year. The primary DV is the Western Ontario & McMaster Universities Arthritis Index (WOMAC). We will also compare healthcare utilisation between the 2 groups. Ethics and Dissemination The protocol was approved by the Madigan Army Medical Center Institutional Review Board. The authors intend to publish the results in a peer-reviewed source. Trial Registration

  2. Family-Based Cluster Randomized Controlled Trial Enhancing Physical Activity and Motor Competence in 4–7-Year-Old Children

    PubMed Central

    Laukkanen, Arto; Pesola, Arto Juhani; Heikkinen, Risto; Sääkslahti, Arja Kaarina; Finni, Taija

    2015-01-01

    Little is known of how to involve families in physical activity (PA) interventions for children. In this cluster randomized controlled trial, we recruited families with four- to seven-year-old children to participate in a year-long study where parents in the intervention group families (n = 46) received tailored counseling to increase children’s PA. Structured PA was not served. Control group families (n = 45) did not receive any counseling. PA in all children (n = 91; mean age 6.16 ± 1.13 years at the baseline) was measured by accelerometers at the baseline and after three, six, nine and 12 months. Motor competence (MC) (n = 89) was measured at the baseline and after six and 12 months by a KTK (KörperkoordinationsTest für Kinder) and throwing and catching a ball (TCB) protocols. The effect of parental counseling on study outcomes was analyzed by a linear mixed-effects model fit by REML and by a Mann-Whitney U test in the case of the TCB. As season was hypothesized to affect counseling effect, an interaction of season on the study outcomes was examined. The results show significant decrease of MVPA in the intervention group when compared to the control group (p < .05). The TCB showed a nearly significant improvement at six months in the intervention group compared to the controls (p = .051), but not at 12 months. The intervention group had a steadier development of the KTK when the interaction of season was taken into account. In conclusion, more knowledge of family constructs associating with the effectiveness of counseling is needed for understanding how to enhance PA in children by parents. However, a hypothesis may be put forward that family-based counseling during an inactive season rather than an active season may provide a more lasting effect on the development of KTK in children. Trial Registration Controlled-Trials.com ISRCTN28668090 PMID:26502183

  3. Evaluating clinical trial design: systematic review of randomized vehicle-controlled trials for determining efficacy of benzoyl peroxide topical therapy for acne.

    PubMed

    Lamel, Sonia A; Sivamani, Raja K; Rahvar, Maral; Maibach, Howard I

    2015-11-01

    Determined efficacies of benzoyl peroxide may be affected by study design, implementation, and vehicle effects. We sought to elucidate areas that may allow improvement in determining accurate treatment efficacies by determining rates of active treatment and vehicle responders in randomized controlled trials assessing the efficacy of topical benzoyl peroxide to treat acne. We conducted a systematic review of randomized vehicle-controlled trials evaluating the efficacy of topical benzoyl peroxide for the treatment of acne. We compared response rates of vehicle treatment arms versus those in benzoyl peroxide arms. Twelve trials met inclusion criteria with 2818 patients receiving benzoyl peroxide monotherapy treatment and 2004 receiving vehicle treatment. The average percent reduction in total number of acne lesions was 44.3 (SD = 9.2) and 27.8 (SD = 21.0) for the active and vehicle treatment groups, respectively. The average reduction in non-inflammatory lesions was 41.5 % (SD = 9.4) in the active treatment group and 27.0 % (SD = 20.9) in the vehicle group. The average percent decrease in inflammatory lesions was 52.1 (SD = 10.4) in the benzoyl peroxide group and 34.7 (SD = 22.7) in the vehicle group. The average percentage of participants achieving success per designated study outcomes was 28.6 (SD = 17.3) and 15.2 (SD = 9.5) in the active treatment and vehicle groups, respectively. Patient responses in randomized controlled trials evaluating topical acne therapies may be affected by clinical trial design, implementation, the biologic effects of vehicles, and natural disease progression. "No treatment" groups may facilitate determination of accurate treatment efficacies.

  4. Increasing Physical Activity in Mothers Using Video Exercise Groups and Exercise Mobile Apps: Randomized Controlled Trial

    PubMed Central

    Chan, June Maylin; Vittinghoff, Eric; Van Blarigan, Erin Lynn; Hecht, Frederick

    2018-01-01

    Background Women significantly decrease their activity levels in the transition to motherhood. Digital health technologies are low cost, scalable, and can provide an effective delivery mechanism for behavior change. This is the first study that examines the use of videoconferencing and mobile apps to create exercise groups for mothers. Objective The aim of the study was to test the feasibility, acceptability, and effectiveness of an individually adaptive and socially supportive physical activity intervention incorporating videoconferencing and mobile apps for mothers. Methods The Moms Online Video Exercise Study was an 8-week, 2-armed, Web-based randomized trial comparing the effectiveness of a group exercise intervention with a waitlist control. Healthy mothers with at least 1 child under the age of 12 years were recruited through Facebook and email listservs. Intervention participants joined exercise groups using videoconferencing (Google Hangouts) every morning on weekdays and exercised together in real time, guided by exercise mobile apps (eg, Nike+, Sworkit) of their choice. Waitlist control participants had access to recommended mobile apps and an invitation to join an exercise group after the 8-week study period. Main outcomes assessed included changes in self-reported moderate, vigorous, and moderate to vigorous physical activity (MVPA) minutes per week in aggregate and stratified by whether women met Centers for Disease Control and Prevention guidelines for sufficient aerobic activity at baseline. Outcomes were measured through self-assessed Web-based questionnaires at baseline and 8 weeks. Results The intervention was effective at increasing exercise for inactive women and proved to be feasible and acceptable to all participants. A total of 64 women were randomized, 30 to intervention and 34 to control. Women attended 2.8 sessions per week. There was a strong, but not statistically significant, trend toward increasing moderate, vigorous, and MVPA minutes

  5. Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States

    PubMed Central

    McClure, Erin A.; King, Jacqueline S.; Wahle, Aimee; Matthews, Abigail G.; Sonne, Susan C.; Lofwall, Michelle R.; McRae-Clark, Aimee L.; Ghitza, Udi E.; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S.; Gray, Kevin M.

    2017-01-01

    Background Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment Episodes Data Set – Admissions. Methods Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. Results Results showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. Conclusions These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. PMID:28511033

  6. Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States.

    PubMed

    McClure, Erin A; King, Jacqueline S; Wahle, Aimee; Matthews, Abigail G; Sonne, Susan C; Lofwall, Michelle R; McRae-Clark, Aimee L; Ghitza, Udi E; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S; Gray, Kevin M

    2017-07-01

    Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment: Episodes Data Set - Admissions. Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Intensified treatment with high dose Rifampicin and Levofloxacin compared to standard treatment for adult patients with Tuberculous Meningitis (TBM-IT): protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Tuberculous meningitis is the most severe form of tuberculosis. Mortality for untreated tuberculous meningitis is 100%. Despite the introduction of antibiotic treatment for tuberculosis the mortality rate for tuberculous meningitis remains high; approximately 25% for HIV-negative and 67% for HIV positive patients with most deaths occurring within one month of starting therapy. The high mortality rate in tuberculous meningitis reflects the severity of the condition but also the poor antibacterial activity of current treatment regimes and relatively poor penetration of these drugs into the central nervous system. Improving the antitubercular activity in the central nervous system of current therapy may help improve outcomes. Increasing the dose of rifampicin, a key drug with known poor cerebrospinal fluid penetration may lead to higher drug levels at the site of infection and may improve survival. Of the second generation fluoroquinolones, levofloxacin may have the optimal pharmacological features including cerebrospinal fluid penetration, with a ratio of Area Under the Curve (AUC) in cerebrospinal fluid to AUC in plasma of >75% and strong bactericidal activity against Mycobacterium tuberculosis. We propose a randomized controlled trial to assess the efficacy of an intensified anti-tubercular treatment regimen in tuberculous meningitis patients, comparing current standard tuberculous meningitis treatment regimens with standard treatment intensified with high-dose rifampicin and additional levofloxacin. Methods/Design A randomized, double blind, placebo-controlled trial with two parallel arms, comparing standard Vietnamese national guideline treatment for tuberculous meningitis with standard treatment plus an increased dose of rifampicin (to 15 mg/kg/day total) and additional levofloxacin. The study will include 750 patients (375 per treatment group) including a minimum of 350 HIV-positive patients. The calculation assumes an overall mortality of 40% vs. 30

  8. A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Focal/Grid Photocoagulation for Diabetic Macular Edema

    PubMed Central

    2009-01-01

    Objective To evaluate the efficacy and safety of 1 mg and 4 mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME). Design Multi-center randomized clinical trial Participants 840 study eyes of 693 subjects with DME involving the fovea and visual acuity 20/40 to 20/320 Methods Eyes were randomized to focal/grid photocoagulation (N=330), 1 mg intravitreal triamcinolone (N=256), or 4 mg intravitreal triamcinolone (N=254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was at 2 years. Main Outcome Measures Visual acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) method (primary), optical coherence tomography (OCT)-measured retinal thickness (secondary), and safety. Results At 4 months, mean visual acuity was better in the 4 mg triamcinolone group than in either the laser group (P<0.001) or the 1 mg triamcinolone group (P=0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other two groups (at 2 years, P=0.02 comparing the laser and 1 mg groups, P=0.002 comparing the laser and 4 mg groups, and P=0.49 comparing the 1mg and 4 mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. OCT results generally paralleled the visual acuity results. Intraocular pressure was increased from baseline by ≥10 mm Hg at any visit in 4%, 16%, and 33% of eyes in the three treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the three treatment groups, respectively. Conclusions Over a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1 mg or 4 mg doses of preservative

  9. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.

    PubMed

    2008-09-01

    To evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME). Multicenter, randomized clinical trial. Eight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320. Eyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years. Visual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety. At 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively. Over a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for

  10. Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion.

    PubMed

    van Vollenhoven, Ronald F; Bolce, Rebecca; Hambardzumyan, Karen; Saevarsdottir, Saedis; Forslind, Kristina; Petersson, Ingemar F; Sasso, Eric H; Hwang, C C; Segurado, Oscar G; Geborek, Pierre

    2015-11-01

    Rheumatoid arthritis (RA) clinical trials often exclude patients who have low C-reactive protein (CRP) levels, which slows enrollment into the trial. The purpose of this study was to determine whether high Multi-Biomarker Disease Activity (MBDA) scores (>44) in RA patients with low CRP levels (≤10 mg/liter) could be used as a complement to CRP levels >10 mg/liter to enhance patient recruitment without affecting clinical trial outcomes. We evaluated patients from the Swedish Pharmacotherapy (SWEFOT) trial, which did not include any selection criteria for CRP levels. Clinical outcomes were assessed after 3 months of methotrexate (MTX) monotherapy in MTX-naive RA patients (n = 220) and after 3-10 months of add-on therapy in patients who were incomplete responders to MTX alone (MTX-IR) (n = 127). Radiographic outcomes were assessed at 1 year in all patients. Within each cohort, the outcomes were compared between patients with a CRP level of ≤10 mg/liter and an MBDA score of >44 at the start of the respective treatment interval versus those with a CRP level of >10 mg/liter. Patients with both a CRP level of ≤10 mg/liter and an MBDA score of >44 at baseline had clinical and radiographic outcomes that were comparable to those in patients with a CRP level of >10 mg/liter at baseline. This broadened definition of the inclusion criteria identified an additional 24% of patients in the MTX-naive cohort and 47% in the MTX-IR cohort. Patient recruitment into RA clinical trials may be substantially enhanced, without any decrease in clinical and radiographic outcomes, by using as an inclusion criterion "a CRP level of >10 mg/liter and/or an MBDA score of >44." © 2015 The Authors. Arthritis & Rheumatology is published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology.

  11. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening.

    PubMed

    Wong, Arthur D; Kirby, John; Guyatt, Gordon H; Moayyedi, Paul; Vora, Parag; You, John J

    2013-02-11

    Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment. Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse. After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01). Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging. Clinicaltrials.gov NCT00865527.

  12. Patient-experienced effect of an active implementation of a disease management programme for COPD – a randomised trial

    PubMed Central

    2013-01-01

    Background People living with chronic disease currently account for the majority of the total healthcare costs. The Central Denmark Region implemented a disease management programme (DMP) for chronic obstructive pulmonary disease (COPD) in 2008. This presented an opportunity to examine the effect of an evidence-based, planned and proactive implementation of a DMP compared to the usual implementation strategy. Methods We performed a block- and cluster-randomised controlled trial with two groups and an extra external control group. The primary outcome was patients’ assessment of their care after using an active implementation model for a DMP for COPD measured with the Patient-Assessment-of-Chronic-Illness-Care (PACIC) instrument. At baseline, questionnaires were sent to 2,895 patients identified by an algorithm based on health registry data on lung-related contacts to the healthcare system. Patients were asked to confirm or refute their diagnosis of COPD. Of those who responded, 1,445 (72.8%) confirmed their diagnosis. PACIC data were collected at baseline and at a 12-month follow-up for 744 (51.1%) patients. Results Comparing the three groups after the implementation of the DMP, we found a statistically significantly higher change in the PACIC score in the intervention group than in the control groups. No statistically significant differences were found between the control and the external control groups in any of the dimensions. Conclusions Reinforcing the role of general practice as coordinator for care-and self-management-support with an active implementation of a DMP for COPD made patients score higher on the PACIC instrument, which indicates a better experience of the received healthcare. Trial registration NCT01228708. PMID:24088417

  13. Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

    PubMed Central

    2011-01-01

    Background Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. Methods/Design A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to

  14. Ciclosporin compared with prednisolone therapy for patients with pyoderma gangrenosum: cost-effectiveness analysis of the STOP GAP trial.

    PubMed

    Mason, J M; Thomas, K S; Ormerod, A D; Craig, F E; Mitchell, E; Norrie, J; Williams, H C

    2017-12-01

    Pyoderma gangrenosum (PG) is a painful, ulcerating skin disease with poor evidence for management. Prednisolone and ciclosporin are the most commonly used treatments, although not previously compared within a randomized controlled trial (RCT). To compare the cost-effectiveness of ciclosporin and prednisolone-initiated treatment for patients with PG. Quality of life (QoL, EuroQoL five dimensions three level questionnaire, EQ-5D-3L) and resource data were collected as part of the STOP GAP trial: a multicentre, parallel-group, observer-blind RCT. Within-trial analysis used bivariate regression of costs and quality-adjusted life years (QALYs), with multiple imputation of missing data, informing a probabilistic assessment of incremental treatment cost-effectiveness from a health service perspective. In the base case analysis, when compared with prednisolone, ciclosporin was cost-effective due to a reduction in costs [net cost: -£1160; 95% confidence interval (CI) -2991 to 672] and improvement in QoL (net QALYs: 0·055; 95% CI 0·018-0·093). However, this finding appears driven by a minority of patients with large lesions (≥ 20 cm 2 ) (net cost: -£5310; 95% CI -9729 to -891; net QALYs: 0·077; 95% CI 0·004-0·151). The incremental cost-effectiveness of ciclosporin for the majority of patients with smaller lesions was £23 374/QALY, although the estimate is imprecise: the probability of being cost-effective at a willingness-to-pay of £20 000/QALY was 43%. Consistent with the clinical findings of the STOP GAP trial, patients with small lesions should receive treatment guided by the side-effect profiles of the drugs and patient preference - neither strategy is clearly a preferred use of National Health Service resources. However, ciclosporin-initiated treatment may be more cost-effective for patients with large lesions. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

  15. A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children.

    PubMed

    Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2012-01-01

    Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Sixty-six infants with DD (aged < 3 years) were randomized to receive either aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications. The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

  16. The healthy steps study: a randomized controlled trial of a pedometer-based green prescription for older adults. Trial protocol.

    PubMed

    Kolt, Gregory S; Schofield, Grant M; Kerse, Ngaire; Garrett, Nicholas; Schluter, Philip J; Ashton, Toni; Patel, Asmita

    2009-11-01

    Graded health benefits of physical activity have been demonstrated for the reduction of coronary heart disease, some cancers, and type-2 diabetes, and for injury reduction and improvements in mental health. Older adults are particularly at risk of physical inactivity, and would greatly benefit from successful targeted physical activity interventions. The Healthy Steps study is a 12-month randomized controlled trial comparing the efficacy of a pedometer-based Green Prescription with the conventional time-based Green Prescription in increasing and maintaining physical activity levels in low-active adults over 65 years of age. The Green Prescription interventions involve a primary care physical activity prescription with 3 follow-up telephone counselling sessions delivered by trained physical activity counsellors over 3 months. Those in the pedometer group received a pedometer and counselling based around increasing steps that can be monitored on the pedometer, while those in the standard Green Prescription group received counselling using time-based goals. Baseline, 3 month (end of intervention), and 12 month measures were assessed in face-to-face home visits with outcomes measures being physical activity (Auckland Heart Study Physical Activity Questionnaire), quality of life (SF-36 and EQ-5D), depressive symptoms (Geriatric Depression Scale), blood pressure, weight status, functional status (gait speed, chair stands, and tandem balance test) and falls and adverse events (self-report). Utilisation of health services was assessed for the economic evaluation carried out alongside this trial. As well, a process evaluation of the interventions and an examination of barriers and motives for physical activity in the sample were conducted. The perceptions of primary care physicians in relation to delivering physical activity counselling were also assessed. The findings from the Healthy Steps trial are due in late 2009. If successful in improving physical activity in older

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

    PubMed

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

    2017-02-01

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

  18. Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

    PubMed

    Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

    2016-02-01

    We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Launching a Novel Preclinical Infrastructure: Comparative Oncology Trials Consortium Directed Therapeutic Targeting of TNFα to Cancer Vasculature

    PubMed Central

    Mazcko, Christina; Hanna, Engy; Kachala, Stefan; LeBlanc, Amy; Newman, Shelley; Vail, David; Henry, Carolyn; Thamm, Douglas; Sorenmo, Karin; Hajitou, Amin; Pasqualini, Renata; Arap, Wadih

    2009-01-01

    Background Under the direction and sponsorship of the National Cancer Institute, we report on the first pre-clinical trial of the Comparative Oncology Trials Consortium (COTC). The COTC is a novel infrastructure to integrate cancers that naturally develop in pet dogs into the development path of new human drugs. Trials are designed to address questions challenging in conventional preclinical models and early phase human trials. Large animal spontaneous cancer models can be a valuable addition to successful studies of cancer biology and novel therapeutic drug, imaging and device development. Methodology/Principal Findings Through this established infrastructure, the first trial of the COTC (COTC001) evaluated a targeted AAV-phage vector delivering tumor necrosis factor (RGD-A-TNF) to αV integrins on tumor endothelium. Trial progress and data was reviewed contemporaneously using a web-enabled electronic reporting system developed for the consortium. Dose-escalation in cohorts of 3 dogs (n = 24) determined an optimal safe dose (5×1012 transducing units intravenous) of RGD-A-TNF. This demonstrated selective targeting of tumor-associated vasculature and sparing of normal tissues assessed via serial biopsy of both tumor and normal tissue. Repetitive dosing in a cohort of 14 dogs, at the defined optimal dose, was well tolerated and led to objective tumor regression in two dogs (14%), stable disease in six (43%), and disease progression in six (43%) via Response Evaluation Criteria in Solid Tumors (RECIST). Conclusions/Significance The first study of the COTC has demonstrated the utility and efficiency of the established infrastructure to inform the development of new cancer drugs within large animal naturally occurring cancer models. The preclinical evaluation of RGD-A-TNF within this network provided valuable and necessary data to complete the design of first-in-man studies. PMID:19330034

  20. Huperzine A for Alzheimer’s Disease: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

    PubMed Central

    Yang, Guoyan; Wang, Yuyi; Tian, Jinzhou; Liu, Jian-Ping

    2013-01-01

    Background 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. Methods 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) Results 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. Conclusions 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

  1. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol

    PubMed Central

    Holt, Anne-Marie; Jancey, Jonine; Lee, Andy H; Kerr, Deborah A; Hills, Andrew P; Anderson, Annie S; Howat, Peter A

    2014-01-01

    Introduction Physical activity levels of Australia's ageing population are declining and coincidentally rates of overweight and obesity are increasing. Adequate levels of physical activity and a healthy diet are recognised as important lifestyle factors for the maintenance of a healthy weight and prevention of chronic diseases. Retirement village (RV) residents rarely engage in physical activity and nutrition programmes offered, with poor attendance and low use of existing facilities such as on-site fitness centres and classes and nutrition seminars. The RV provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight. Method and analysis This cluster-randomised controlled trial will evaluate a physical activity, nutrition and healthy weight management intervention for insufficiently active (‘not achieving 150 min of moderate-intensity physical activity per week’) adults aged 60–75 residing in RV's. A total of 400 participants will be recruited from 20 randomly selected RV's in Perth, Western Australia. Villages will be assigned to either the intervention group (n=10) or the control group (n=10) each containing 200 participants. The Retirement Village Physical Activity and Nutrition for Seniors (RVPANS) programme is a home-based physical activity and nutrition programme that includes educational resources, along with facilitators who will motivate and guide the participants during the 6-month intervention. Descriptive statistics and mixed regression models will be performed to assess the intervention effects. This trial will evaluate an intervention for the modification of health risk factors in the RV setting. Such research conducted in RV's has been limited. Ethics and dissemination Curtin University Human Research Ethics Committee (approval number: HR128/2012). Dissemination of the study results will occur

  2. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  3. The prevalence of patient engagement in published trials: a systematic review.

    PubMed

    Fergusson, Dean; Monfaredi, Zarah; Pussegoda, Kusala; Garritty, Chantelle; Lyddiatt, Anne; Shea, Beverley; Duffett, Lisa; Ghannad, Mona; Montroy, Joshua; Hassan Murad, M; Pratt, Misty; Rader, Tamara; Shorr, Risa; Yazdi, Fatemeh

    2018-01-01

    With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main

  4. A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission.

    PubMed

    Shepperd, Sasha; Cradduck-Bamford, Andrea; Butler, Chris; Ellis, Graham; Godfrey, Mary; Gray, Alastair; Hemsley, Anthony; Khanna, Pradeep; Langhorne, Peter; McCaffrey, Patricia; Mirza, Lubena; Pushpangadan, Maj; Ramsay, Scott; Schiff, Rebekah; Stott, David; Young, John; Yu, Ly-Mee

    2017-10-23

    There is concern that existing models of acute hospital care will become unworkable as the health service admits an increasing number of frail older people with complex health needs, and that there is inadequate evidence to guide the planning of acute hospital level services. We aim to evaluate whether geriatrician-led admission avoidance to hospital at home is an effective alternative to hospital admission. We are conducting a multi-site randomised open trial of geriatrician-led admission avoidance hospital at home, compared with admission to hospital. We are recruiting older people with markers of frailty or prior dependence who have been referred to admission avoidance hospital at home for an acute medical event. This includes patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease. Participants are randomised using a computerised random number generator to geriatrician-led admission avoidance hospital at home or a control group of inpatient admission in a 2:1 ratio in favour of the intervention. The primary endpoint 'living at home' (the inverse of death or living in a residential care setting) is measured at 6 months follow-up, and we also collect data on this outcome at 12 months. Secondary outcomes include the incidence of delirium, mortality, new long-term residential care, cognitive impairment, activities of daily living, quality of life and quality-adjusted survival, length of stay, readmission or transfer to hospital. We will conduct a parallel economic evaluation, and a process evaluation that includes an interview study to explore the experiences of patients and carers. Health systems around the world are examining how to provide acute hospital-level care to older adults in greater numbers with a fixed or shrinking hospital resource. This trial is the first large multi-site randomised trial of geriatrician-led admission avoidance hospital at home, and will

  5. Techniques for extracting single-trial activity patterns from large-scale neural recordings

    PubMed Central

    Churchland, Mark M; Yu, Byron M; Sahani, Maneesh; Shenoy, Krishna V

    2008-01-01

    Summary Large, chronically-implanted arrays of microelectrodes are an increasingly common tool for recording from primate cortex, and can provide extracellular recordings from many (order of 100) neurons. While the desire for cortically-based motor prostheses has helped drive their development, such arrays also offer great potential to advance basic neuroscience research. Here we discuss the utility of array recording for the study of neural dynamics. Neural activity often has dynamics beyond that driven directly by the stimulus. While governed by those dynamics, neural responses may nevertheless unfold differently for nominally identical trials, rendering many traditional analysis methods ineffective. We review recent studies – some employing simultaneous recording, some not – indicating that such variability is indeed present both during movement generation, and during the preceding premotor computations. In such cases, large-scale simultaneous recordings have the potential to provide an unprecedented view of neural dynamics at the level of single trials. However, this enterprise will depend not only on techniques for simultaneous recording, but also on the use and further development of analysis techniques that can appropriately reduce the dimensionality of the data, and allow visualization of single-trial neural behavior. PMID:18093826

  6. The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics.

    PubMed

    Garner, Alan A; Fearnside, Michael; Gebski, Val

    2013-09-14

    The utility of advanced prehospital interventions for severe blunt traumatic brain injury (BTI) remains controversial. Of all trauma patient subgroups it has been anticipated that this patient group would most benefit from advanced prehospital interventions as hypoxia and hypotension have been demonstrated to be associated with poor outcomes and these factors may be amenable to prehospital intervention. Supporting evidence is largely lacking however. In particular the efficacy of early anaesthesia/muscle relaxant assisted intubation has proved difficult to substantiate. This article describes the design and protocol of the Head Injury Retrieval Trial (HIRT) which is a randomised controlled single centre trial of physician prehospital care (delivering advanced interventions such as rapid sequence intubation and blood transfusion) in addition to paramedic care for severe blunt TBI compared with paramedic care alone. Primary endpoint is Glasgow Outcome Scale score at six months post injury. Issues with trial integrity resulting from drop ins from standard care to the treatment arm as the result of policy changes by the local ambulance system are discussed. This randomised controlled trial will contribute to the evaluation of the efficacy of advance prehospital interventions in severe blunt TBI. ClinicalTrials.gov: NCT00112398.

  7. Recruiting a Diverse Group of Middle School Girls into the Trial of Activity for Adolescent Girls

    ERIC Educational Resources Information Center

    Elder, John P.; Shuler, LaVerne; Moe, Stacey G.; Grieser, Mira; Pratt, Charlotte; Cameron, Sandra; Hingle, Melanie; Pickrel, Julie L.; Saksvig, Brit I.; Schachter, Kenneth; Greer, Susan; Bothwell, Elizabeth K. Guth

    2008-01-01

    Background: School-based study recruitment efforts are both time consuming and challenging. This paper highlights the recruitment strategies employed by the national, multisite Trial of Activity for Adolescent Girls (TAAG), a study designed to measure the effectiveness of an intervention to reduce the decline of physical activity levels among…

  8. Promoting gross motor skills and physical activity in childcare: A translational randomized controlled trial.

    PubMed

    Jones, Rachel A; Okely, Anthony D; Hinkley, Trina; Batterham, Marijka; Burke, Claire

    2016-09-01

    Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  9. Internet treatment for generalized anxiety disorder: a randomized controlled trial comparing clinician vs. technician assistance.

    PubMed

    Robinson, Emma; Titov, Nickolai; Andrews, Gavin; McIntyre, Karen; Schwencke, Genevieve; Solley, Karen

    2010-06-03

    Internet-based cognitive behavioural therapy (iCBT) for generalized anxiety disorder (GAD) has been shown to be effective when guided by a clinician. The present study sought to replicate this finding, and determine whether support from a technician is as effective as guidance from a clinician. Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au) research program and 150 participants with GAD were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for GAD comprising six online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 10 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Penn State Worry Questionnaire (PSWQ) and the Generalized Anxiety Disorder-7 Item (GAD-7). Completion rates were high, and both treatment groups reduced scores on the PSWQ (p<0.001) and GAD-7 (p<0.001) compared to the delayed treatment group, but did not differ from each other. Within group effect sizes on the PSWQ were 1.16 and 1.07 for the clinician- and technician-assisted groups, respectively, and on the GAD-7 were 1.55 and 1.73, respectively. At 3 month follow-up participants in both treatment groups had sustained the gains made at post-treatment. Participants in the clinician-assisted group had made further gains on the PSWQ. Approximately 81 minutes of clinician time and 75 minutes of technician time were required per participant during the 10 week treatment program. Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment/control group did not improve. These results provide

  10. Comparing the Effects of Multisensory Stimulation and Individualized Music Sessions on Elderly People with Severe Dementia: A Randomized Controlled Trial.

    PubMed

    Sánchez, Alba; Maseda, Ana; Marante-Moar, M Pilar; de Labra, Carmen; Lorenzo-López, Laura; Millán-Calenti, José Carlos

    2016-03-08

    The objective of this study was to compare the effects of a multisensory stimulation environment (MSSE) and individualized music sessions on agitation, emotional and cognitive status, and dementia severity in a sample of institutionalized patients with severe dementia. Twenty-two participants with a diagnosis of severe or very severe dementia were randomly assigned to two groups: MSSE and individualized music sessions. Both groups participated in two 30-min weekly sessions over 16 weeks. Outcomes were agitation (Cohen-Mansfield Agitation Inventory, CMAI), mood (Cornell Scale for Depression in Dementia, CSDD), anxiety (Rating Anxiety in Dementia, RAID), cognitive function (Severe Mini-Mental State Examination, SMMSE), and the overall severity of dementia (Bedford Alzheimer Nursing Severity Scale, BANS-S). They were assessed at baseline (pre-trial), in the middle (mid-trial), at the end of the intervention (post-trial), and 8 weeks after the intervention (follow-up). Patients in the MSSE group showed significant improvement in their RAID and BANS-S scores compared with the individualized music group post- versus pre-trial. With regard to agitation, there was improvement during the intervention in both the MSSE and individualized music groups in the CMAI total score after 16 weeks of intervention, with no significant differences between the groups. The results suggest that MSSE could have better effects on anxiety symptoms and dementia severity in comparison with individualized music sessions in elderly patients with severe dementia.

  11. Effectiveness of an Activity Tracker- and Internet-Based Adaptive Walking Program for Adults: A Randomized Controlled Trial.

    PubMed

    Poirier, Josée; Bennett, Wendy L; Jerome, Gerald J; Shah, Nina G; Lazo, Mariana; Yeh, Hsin-Chieh; Clark, Jeanne M; Cobb, Nathan K

    2016-02-09

    The benefits of physical activity are well documented, but scalable programs to promote activity are needed. Interventions that assign tailored and dynamically adjusting goals could effect significant increases in physical activity but have not yet been implemented at scale. Our aim was to examine the effectiveness of an open access, Internet-based walking program that assigns daily step goals tailored to each participant. A two-arm, pragmatic randomized controlled trial compared the intervention to no treatment. Participants were recruited from a workplace setting and randomized to a no-treatment control (n=133) or to treatment (n=132). Treatment participants received a free wireless activity tracker and enrolled in the walking program, Walkadoo. Assessments were fully automated: activity tracker recorded primary outcomes (steps) without intervention by the participant or investigators. The two arms were compared on change in steps per day from baseline to follow-up (after 6 weeks of treatment) using a two-tailed independent samples t test. Participants (N=265) were 66.0% (175/265) female with an average age of 39.9 years. Over half of the participants (142/265, 53.6%) were sedentary (<5000 steps/day) and 44.9% (119/265) were low to somewhat active (5000-9999 steps/day). The intervention group significantly increased their steps by 970 steps/day over control (P<.001), with treatment effects observed in sedentary (P=.04) and low-to-somewhat active (P=.004) participants alike. The program is effective in increasing daily steps. Participants benefited from the program regardless of their initial activity level. A tailored, adaptive approach using wireless activity trackers is realistically implementable and scalable. Clinicaltrials.gov NCT02229409, https://clinicaltrials.gov/ct2/show/NCT02229409 (Archived by WebCite at http://www.webcitation.org/6eiWCvBYe).

  12. Comparison of Characteristics and Outcomes of Trial Participants and Nonparticipants: Example of Blood and Marrow Transplant Clinical Trials Network 0201 Trial.

    PubMed

    Khera, Nandita; Majhail, Navneet S; Brazauskas, Ruta; Wang, Zhiwei; He, Naya; Aljurf, Mahmoud D; Akpek, Görgün; Atsuta, Yoshiko; Beattie, Sara; Bredeson, Christopher N; Burns, Linda J; Dalal, Jignesh D; Freytes, César O; Gupta, Vikas; Inamoto, Yoshihiro; Lazarus, Hillard M; LeMaistre, Charles F; Steinberg, Amir; Szwajcer, David; Wingard, John R; Wirk, Baldeep; Wood, William A; Joffe, Steven; Hahn, Theresa E; Loberiza, Fausto R; Anasetti, Claudio; Horowitz, Mary M; Lee, Stephanie J

    2015-10-01

    Controversy surrounds the question of whether clinical trial participants have better outcomes than comparable patients who are not treated on a trial. We explored this question using a recent large, randomized, multicenter study comparing peripheral blood (PB) with bone marrow transplantation from unrelated donors, conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). We compared characteristics and outcomes of study participants (n = 494) and nonparticipants (n = 1384) who appeared eligible and received similar treatment without enrolling on the BMT CTN trial at participating centers during the study time period. Data were obtained from the Center for International Blood and Marrow Transplant Research. Outcomes were compared between the 2 groups using Cox proportional hazards regression models. No significant differences in age, sex, disease distribution, race/ethnicity, HLA matching, comorbidities, and interval from diagnosis to hematopoietic cell transplantation were seen between the participants and nonparticipants. Nonparticipants were more likely to have lower performance status, lower risk disease, and older donors, and to receive myeloablative conditioning and antithymocyte globulin. Nonparticipants were also more likely to receive PB grafts, the intervention tested in the trial (66% versus 50%, P < .001). Overall survival, transplantation-related mortality, and incidences of acute or chronic graft-versus-host disease were comparable between the 2 groups though relapse was higher (hazard ratio, 1.22; 95% confidence interval, 1.02 to 1.46; P = .028) in nonparticipants. Despite differences in certain baseline characteristics, survival was comparable between study participants and nonparticipants. The results of the BMT CTN trial appear generalizable to the population of trial-eligible patients. Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  13. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison.

    PubMed

    Cameron, Chris; Zummo, Jacqueline; Desai, Dharmik N; Drake, Christine; Hutton, Brian; Kotb, Ahmed; Weiden, Peter J

    Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. There are no direct-comparison studies with paliperidone palmitate (PP; long-acting antipsychotic used most often in acute settings) for the acute psychotic episode. To indirectly compare efficacy and safety of the pivotal AL study with all PP studies meeting indirect comparison criteria. Systematic searches of MEDLINE, Embase, Cochrane CENTRAL, PsycINFO, ClinicalTrials.gov, International Clinical Trials Registry Platform, and gray literature were performed to identify randomized controlled trials of PP with similar designs to the AL trial. Bayesian network meta-analysis compared treatments with respect to symptom response and tolerability issues including weight gain, akathisia, parkinsonism, and likelihood of treatment-emergent adverse events. Three appropriate PP studies were identified for indirect comparison. Both doses of AL (441 mg and 882 mg monthly) were used and compared with two efficacious doses of PP (156 mg and 234 mg monthly). All four active-treatment conditions were associated with comparable reductions in acute symptoms (Positive and Negative Syndrome Scale) versus placebo and were of similar magnitude (range of mean difference -8.12 to -12.01, with overlapping 95% credible intervals). Between-group comparisons of active-treatment arms were associated with summary estimates of magnitude near 0. No clinically meaningful differences in selected safety or tolerability parameter incidence were found between active treatments. These results suggest that both AL and PP are effective for treatment of adults experiencing acute exacerbation of schizophrenia. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  14. Effectiveness of a Web 2.0 Intervention to Increase Physical Activity in Real-World Settings: Randomized Ecological Trial.

    PubMed

    Vandelanotte, Corneel; Kolt, Gregory S; Caperchione, Cristina M; Savage, Trevor N; Rosenkranz, Richard R; Maeder, Anthony J; Van Itallie, Anetta; Tague, Rhys; Oldmeadow, Christopher; Mummery, W Kerry; Duncan, Mitch J

    2017-11-13

    The translation of Web-based physical activity intervention research into the real world is lacking and becoming increasingly important. To compare usage and effectiveness, in real-world settings, of a traditional Web 1.0 Web-based physical activity intervention, providing limited interactivity, to a Web 2.0 Web-based physical activity intervention that includes interactive features, such as social networking (ie, status updates, online "friends," and personalized profile pages), blogs, and Google Maps mash-ups. Adults spontaneously signing up for the freely available 10,000 Steps website were randomized to the 10,000 Steps website (Web 1.0) or the newly developed WALK 2.0 website (Web 2.0). Physical activity (Active Australia Survey), quality of life (RAND 36), and body mass index (BMI) were assessed at baseline, 3 months, and 12 months. Website usage was measured continuously. Analyses of covariance were used to assess change over time in continuous outcome measures. Multiple imputation was used to deal with missing data. A total of 1328 participants completed baseline assessments. Only 3-month outcomes (224 completers) were analyzed due to high attrition at 12 months (77 completers). Web 2.0 group participants increased physical activity by 92.8 minutes per week more than those in the Web 1.0 group (95% CI 28.8-156.8; P=.005); their BMI values also decreased more (-1.03 kg/m2, 95% CI -1.65 to -0.41; P=.001). For quality of life, only the physical functioning domain score significantly improved more in the Web 2.0 group (3.6, 95% CI 1.7-5.5; P<.001). The time between the first and last visit to the website (3.57 vs 2.22 weeks; P<.001) and the mean number of days the website was visited (9.02 vs 5.71 days; P=.002) were significantly greater in the Web 2.0 group compared to the Web 1.0 group. The difference in time-to-nonusage attrition was not statistically significant between groups (Hazard Ratio=0.97, 95% CI 0.86-1.09; P=.59). Only 21.99% (292/1328) of

  15. A cluster randomised trial of cloth masks compared with medical masks in healthcare workers

    PubMed Central

    MacIntyre, C Raina; Seale, Holly; Dung, Tham Chi; Hien, Nguyen Tran; Nga, Phan Thi; Chughtai, Abrar Ahmad; Rahman, Bayzidur; Dwyer, Dominic E; Wang, Quanyi

    2015-01-01

    Objective The aim of this study was to compare the efficacy of cloth masks to medical masks in hospital healthcare workers (HCWs). The null hypothesis is that there is no difference between medical masks and cloth masks. Setting 14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam. Participants 1607 hospital HCWs aged ≥18 years working full-time in selected high-risk wards. Intervention Hospital wards were randomised to: medical masks, cloth masks or a control group (usual practice, which included mask wearing). Participants used the mask on every shift for 4 consecutive weeks. Main outcome measure Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed respiratory virus infection. Results The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%. Conclusions This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12610000887077. PMID

  16. Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

    PubMed Central

    Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

    2016-01-01

    Objective To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Design Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Setting Eight centers across the United States, February 2010 to December 2011. Participants 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤9, but who were able to walk 400 m. Interventions A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Main outcome measures Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Results Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men

  17. Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study).

    PubMed

    Gill, Thomas M; Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

    2016-02-03

    To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Eight centers across the United States, February 2010 to December 2011. 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m. A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0

  18. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

    PubMed Central

    Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

    2011-01-01

    Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

  19. Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study).

    PubMed

    Ahola, Riikka; Pyky, Riitta; Jämsä, Timo; Mäntysaari, Matti; Koskimäki, Heli; Ikäheimo, Tiina M; Huotari, Maija-Leena; Röning, Juha; Heikkinen, Hannu I; Korpelainen, Raija

    2013-01-14

    Inactive and unhealthy lifestyles are common among adolescent men. The planned intervention examines the effectiveness of an interactive, gamified activation method, based on tailored health information, peer networks and participation, on physical activity, health and wellbeing in young men. We hypothesize that following the intervention the physical activation group will have an improved physical activity, as well as self-determined and measured health compared with the controls. Conscription-aged men (18 years) attending compulsory annual call-ups for military service in the city of Oulu in Finland (n = 1500) will be randomized to a 6-months intervention (n = 640) or a control group (n = 640) during the fall 2013. A questionnaire on health, health behaviour, diet and wellbeing is administered in the beginning and end of the intervention. In addition, anthropometric measures (height, weight and waist circumference), body composition, grip strength, heart rate variability and aerobic fitness will be measured. The activation group utilizes an online gamified activation method in combination with communal youth services, objective physical activity measurement, social networking, tailored health information and exercise programs according to baseline activity level and the readiness of changes of each individual. Daily physical activity of the participants is monitored in both the activation and control groups. The activation service rewards improvements in physical activity or reductions in sedentary behaviour. The performance and completion of the military service of the participants will also be followed. The study will provide new information of physical activity, health and health behaviour of young men. Furthermore, a novel model including methods for increasing physical activity among young people is developed and its effects tested through an intervention. This unique gamified service for activating young men can provide a translational model for community

  20. Coconut Water Does Not Improve Markers of Hydration During Sub-maximal Exercise and Performance in a Subsequent Time Trial Compared with Water Alone.

    PubMed

    Peart, Daniel J; Hensby, Andy; Shaw, Matthew P

    2017-06-01

    The purpose of this study was to compare markers of hydration during submaximal exercise and subsequent time trial performance when consuming water (PW) or coconut water (CW). There was also a secondary aim to assess the palatability of CW during exercise and voluntary intake during intense exercise. 10 males (age 27.9 ± 4.9 years, body mass 78.1 ± 10.1kg, average max minute power 300.2 ± 28.2W) completed 60-min of submaximal cycling followed by a 10-km time trial on two occasions. During these trials participants consumed either PW or CW in a randomized manner, drinking a 250 ml of the assigned drink between 10-15 min, 25-30 min and 40-45 min, and then drinking ad libitum from 55-min until the end of the time trial. Body mass and urine osmolality were recorded preexercise and then after 30-min, 60-min, and post time trial. Blood glucose, lactate, heart rate, rate of perceived exertion (RPE; 6-20) and ratings of thirst, sweetness, nausea, fullness and stomach upset (1 =very low/none, 5= very high) were recorded during each drink period. CW did not significantly improve time trial performance compared with PW (971.4 ± 50.5 and 966.6 ± 44.8 s respectively; p = .698) and there was also no significant differences between trials for any of the physiological variables measured. However there were subjective differences between the beverages for taste, resulting in a significantly reduced volume of voluntary intake in the CW trial (115 ± 95.41 ml and 208.7 ± 86.22 ml; p < .001).

  1. Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma.

    PubMed

    Erwin, Kim; Martin, Molly A; Flippin, Tara; Norell, Sarah; Shadlyn, Ariana; Yang, Jie; Falco, Paula; Rivera, Jaime; Ignoffo, Stacy; Kumar, Rajesh; Margellos-Anast, Helen; McDermott, Michael; McMahon, Kate; Mosnaim, Giselle; Nyenhuis, Sharmilee M; Press, Valerie G; Ramsay, Jessica E; Soyemi, Kenneth; Thompson, Trevonne M; Krishnan, Jerry A

    2016-01-01

    To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: define design requirements; prototype and refine; and evaluate. Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool over current tools. Engaging end-users in contextual inquiry resulted in CAPE (CHICAGO Action Plan after ED discharge), a new stakeholder-balanced discharge tool, which is being tested in a multicenter comparative effectiveness trial.

  2. Promoting Physical Activity in Middle School Girls: Trial of Activity for Adolescent Girls

    PubMed Central

    Webber, Larry S.; Catellier, Diane J.; Lytle, Leslie A.; Murray, David M.; Pratt, Charlotte A.; Young, Deborah R.; Elder, John P.; Lohman, Timothy G.; Stevens, June; Jobe, Jared B.; Pate, Russell R.

    2008-01-01

    Background Physical activity is important for weight control and good health; however, activity levels decline in the adolescent years, particularly in girls. Design Group randomized controlled trial Setting/participants Middle school girls with English-speaking skills and no conditions to prevent participation in physical activity in 36 schools in six geographically diverse areas of the United States. Random, cross-sectional samples were drawn within schools: 6th graders in 2003 (n=1721) and 8th graders in 2005 (n=3504) and 2006 (n=3502). Intervention A 2-year study-directed intervention (fall 2003 to spring 2005) targeted schools, community agencies, and girls to increase opportunities, support, and incentives for increased physical activity. Components included programs linking schools and community agencies, physical education, health education, and social marketing. A third-year intervention used school and community personnel to direct intervention activities. Main outcome measures The primary outcome, daily MET-weighted minutes of moderate-to-vigorous physical activity (MET-weighted MVPA), was assessed using accelerometry. Percent body fat was assessed using anthropometry. Results After the staff-directed intervention (pre-stated primary outcome), there were no differences (mean= −0.4, 95% CI= CI= −8.2 to 7.4) in adjusted MET-weighted MVPA between 8th-grade girls in schools assigned to intervention or control. Following the Program Champion–directed intervention, girls in intervention schools were more physically active than girls in control schools (mean difference 10.9 MET-weighted minutes of MVPA, 95% CI=0.52–21.2). This difference is about 1.6 minutes of daily MVPA or 80 kcal per week. There were no differences in fitness or percent body fat at either 8th-grade timepoint. Conclusion A school-based, community-linked intervention modestly improved physical activity in girls. PMID:18312804

  3. Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial

    PubMed Central

    2014-01-01

    Background The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. Methods An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres. Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise. Blood pressure and weight were assessed at baseline and 6 months. Results Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Conclusions Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged

  4. Physical activity as treatment for alcohol use disorders (FitForChange): study protocol for a randomized controlled trial.

    PubMed

    Hallgren, Mats; Andersson, Victoria; Ekblom, Örjan; Andréasson, Sven

    2018-02-14

    Help-seeking for alcohol use disorders (AUDs) is low and traditional treatments are often perceived as stigmatizing. Physical activity has positive effects on mental and physical health which could benefit this population. We propose to compare the effects of aerobic training, yoga, and usual care for AUDs in physically inactive Swedish adults. This is a three-group, parallel, single-blind, randomized controlled trial (RCT). In total, 210 adults (aged 18-75 years) diagnosed with an AUD will be invited to participate in a 12-week intervention. The primary study outcome is alcohol consumption measure by the Timeline Follow-back method and the Alcohol Use Disorders Identification Test (AUDIT). Secondary outcomes include: depression, anxiety, perceived stress, sleep quality, physical activity levels, fitness, self-efficacy, health-related quality of life, and cognition. Blood samples will be taken to objectively assess heavy drinking, and saliva to measure cortisol. Acute effects of exercise on the urge to drink alcohol, mood, and anxiety will also be assessed. The treatment potential for exercise in AUDs is substantial as many individuals with the disorder are physically inactive and have comorbid health problems. The study is the first to assess the effects of physical activity as a stand-alone treatment for AUDs. Considerable attention will be given to optimizing exercise adherence. Both the feasibility and treatment effects of exercise interventions in AUDs will be discussed. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (DNR: 2017/1380-3). German Clinical Trials Register, ID: DRKS00012311. Registered on 26 September 2017.

  5. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial

    PubMed Central

    Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-01-01

    Abstract Objectives To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Design Prospective, randomized, 52 week, single blind comparative effectiveness trial. Setting Urban tertiary care academic hospital in the United States between March 2012 and September 2016. Participants 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Interventions Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. Main outcome measures The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient’s global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. Results FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient’s global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with

  6. A systematic review of measurement of endoscopic disease activity and mucosal healing in Crohn's disease: recommendations for clinical trial design.

    PubMed

    Khanna, Reena; Bouguen, Guillaume; Feagan, Brian G; DʼHaens, Geert; Sandborn, William J; Dubcenco, Elena; Baker, K Adam; Levesque, Barrett G

    2014-10-01

    Crohn's disease (CD) is a chronic idiopathic inflammatory disorder of the gastrointestinal tract. Recently, mucosal healing has been proposed as a goal of therapy because clinical symptoms are subjective. Evaluative indices that measure endoscopic disease activity are required to define mucosal healing for clinical trials. The primary objective of this systematic review was to assess the existing evaluative indices that measure disease activity in CD and evaluate their role as outcome measures in clinical trials. A systematic literature review was performed using MEDLINE (Ovid), EMBASE (Ovid), PubMed, the Cochrane Library (CENTRAL), and DDW abstracts to identify randomized controlled trials and controlled clinical trials that used a relevant evaluative index from inception to February 2013. The data obtained from these trials were reviewed and summarized. The initial literature searches identified 2300 citations. After duplicates were removed, 1454 studies remained. After application of the apriori inclusion and exclusion criteria, 109 articles were included and 3 were identified with handsearches. In total, 9 evaluative indices for CD were identified and reviewed. The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score in Crohn's Disease (SES-CD) are indices with the most extensively described operating properties. Both the endoscopic evaluative instrument selected and the definition chosen for mucosal healing affect the validity of assessing endoscopic disease activity during a clinical trial for CD. Currently, the CDEIS and SES-CD have the most data regarding operating properties; however, further validation is required.

  7. Effectiveness of an intervention to facilitate the implementation of healthy eating and physical activity policies and practices in childcare services: a randomised controlled trial.

    PubMed

    Jones, Jannah; Wyse, Rebecca; Finch, Meghan; Lecathelinais, Christophe; Wiggers, John; Marshall, Josephine; Falkiner, Maryann; Pond, Nicole; Yoong, Sze Lin; Hollis, Jenna; Fielding, Alison; Dodds, Pennie; Clinton-McHarg, Tara; Freund, Megan; McElduff, Patrick; Gillham, Karen; Wolfenden, Luke

    2015-10-25

    The primary aim of this study was to evaluate the effectiveness of an intervention to increase the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study also sought to determine if the intervention was effective in improving child dietary intake and increasing child physical activity levels while attending childcare. A parallel group, randomised controlled trial was conducted in a sample of 128 childcare services. Intervention strategies included provision of implementation support staff, securing executive support, staff training, consensus processes, academic detailing visits, tools and resources, performance monitoring and feedback and a communications strategy. The primary outcome of the trial was the proportion of services implementing all seven healthy eating and physical activity policies and practices targeted by the intervention. Outcome data were collected via telephone surveys with nominated supervisors and room leaders at baseline and immediately post-intervention. Secondary trial outcomes included the differences between groups in the number of serves consumed by children for each food group within the Australian Guide to Healthy Eating and in the proportion of children engaged in sedentary, walking or very active physical activity assessed via observation in a random subsample of 36 services at follow-up. There was no significant difference between groups for the primary trial outcome (p = 0.44). Relative to the control group, a significantly larger proportion of intervention group services reported having a written nutrition and physical activity policy (p = 0.05) and providing adult-guided activities to develop fundamental movement skills (p = 0.01). There were no significant differences between groups at follow-up on measures of child dietary intake or physical activity. The findings of the trial were equivocal. While there was no significant difference between groups

  8. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial.

    PubMed

    Chen, Kai; Wu, Yi-Ning; Ren, Yupeng; Liu, Lin; Gaebler-Spira, Deborah; Tankard, Kelly; Lee, Julia; Song, Weiqun; Wang, Maobin; Zhang, Li-Qun

    2016-08-01

    To examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for the treatment of impaired ankles in children with cerebral palsy. A randomized comparative trial design comparing a home-based training group and a laboratory-based training group. Home versus laboratory within a research hospital. Children (N=41) with cerebral palsy who were at Gross Motor Function Classification System level I, II, or III were randomly assigned to 2 groups. Children in home-based and laboratory-based groups were 8.7±2.8 (n=23) and 10.7±6.0 (n=18) years old, respectively. Six-week combined passive stretching and active movement intervention of impaired ankle in a laboratory or home environment using a portable rehabilitation robot. Active dorsiflexion range of motion (as the primary outcome), mobility (6-minute walk test and timed Up and Go test), balance (Pediatric Balance Scale), Selective Motor Control Assessment of the Lower Extremity, Modified Ashworth Scale (MAS) for spasticity, passive range of motion (PROM), strength, and joint stiffness. Significant improvements were found for the home-based group in all biomechanical outcome measures except for PROM and all clinical outcome measures except the MAS. The laboratory-based group also showed significant improvements in all the biomechanical outcome measures and all clinical outcome measures except the MAS. There were no significant differences in the outcome measures between the 2 groups. These findings suggest that the translation of repetitive, goal-directed, biofeedback training through motivating games from the laboratory to the home environment is feasible. The benefits of home-based robot-guided therapy were similar to those of laboratory-based robot-guided therapy. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. The functional organization of trial-related activity in lexical processing after early left hemispheric brain lesions: An event-related fMRI study

    PubMed Central

    Fair, Damien A.; Choi, Alexander H.; Dosenbach, Yannic B.L.; Coalson, Rebecca S.; Miezin, Francis M.; Petersen, Steven E.; Schlaggar, Bradley L.

    2009-01-01

    Children with congenital left hemisphere damage due to perinatal stroke are capable of acquiring relatively normal language functions despite experiencing a cortical insult that in adults often leads to devastating lifetime disabilities. Although this observed phenomenon accepted, its neurobiological mechanisms are not well characterized. In this paper we examined the functional neuroanatomy of lexical processing in 13 children/adolescents with perinatal left hemispheric damage. In contrast to many previous perinatal infarct fMRI studies, we use an event-related design, which allowed us to isolate trial related activity and examine correct and error trials separately. Using both group and single subject analysis techniques we attempt to address several methodological factors that may contribute to some discrepancies in the perinatal lesion literature. These methodological factors include making direct statistical comparisons, using common stereotactic space, using both single-subject and group analyses, and accounting for performance differences. Our group analysis, investigating correct trial related activity (separately from error trials), showed very few statistical differences in the non-involved right hemisphere between patients and performance matched controls. The single subject analysis revealed atypical regional activation patterns in several patients; however, the location of these regions identified in individual patients often varied across subjects. These results are consistent with the idea that alternative functional organization of trial-related activity after left hemisphere lesions is in large part unique to the individual. In addition, reported differences between results obtained with event-related designs and blocked designs may suggest diverging organizing principles for sustained and trial-related activity after early childhood brain injuries. PMID:19819000

  10. Effectiveness of Personalized Feedback Alone or Combined with Peer Support to Improve Physical Activity in Sedentary Older Malays with Type 2 Diabetes: A Randomized Controlled Trial.

    PubMed

    Sazlina, Shariff-Ghazali; Browning, Colette Joy; Yasin, Shajahan

    2015-01-01

    Regular physical activity is an important aspect of self-management among older people with type 2 diabetes but many remain inactive. Interventions to improve physical activity levels have been studied but few studies have evaluated the effects of personalized feedback (PF) or peer support (PS); and there was no study on older people of Asian heritage. Hence, this trial evaluated whether PF only or combined with PS improves physical activity among older Malays with type 2 diabetes (T2DM) compared to usual care only. A three-arm randomized controlled trial was conducted in a primary healthcare clinic in Malaysia. Sixty-nine sedentary Malays aged 60 years and older with T2DM who received usual diabetes care were randomized to PF or PS interventions or as controls for 12 weeks with follow-ups at weeks 24 and 36. Intervention groups performed unsupervised walking activity and received written feedback on physical activity. The PS group also received group and telephone contacts from trained peer mentors. The primary outcome was pedometer steps. Secondary outcomes were self-reported physical activity, cardiovascular risk factors, cardiorespiratory fitness, balance, quality of life, and psychosocial wellbeing. Fifty-two (75.4%) completed the 36-week study. The PS group showed greater daily pedometer readings than the PF and controls (p = 0.001). The PS group also had greater improvement in weekly duration (p < 0.001) and frequency (p < 0.001) of moderate intensity physical activity, scores on the Physical Activity Scale for Elderly (p = 0.003), 6-min walk test (p < 0.001), and social support from friends (p = 0.032) than PF and control groups. The findings suggest that PF combined with PS in older Malays with T2DM improved their physical activity levels, cardiorespiratory fitness, and support from friends. Current Controlled Trials ISRCTN71447000.

  11. The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Approximately 85% of vaginal deliveries are accompanied by perineal trauma. The objective of this trial is to compare the incidence and degree of perineal trauma after primary delivery of the anterior compared with the posterior shoulder during vaginal birth. The hypothesis is that primary delivery of the posterior shoulder reduces the rate and degree of perineal trauma. Methods/design This is a single-centre, randomized controlled trial, with computer-generated randomization in a 1:1 allocation ratio. Women planning their first vaginal delivery (n = 650) are randomized to primary delivery of either the anterior or posterior shoulder. The primary outcome is any perineal trauma. Additional outcomes are the perineal injury subtypes, postpartum bleeding, umbilical artery pH, Apgar score at 5 minutes and any neonatal birth trauma. Perineal trauma is assessed by a midwife or doctor blinded to the method of shoulder delivery. All midwives are trained in the two methods of shoulder delivery and in the grading of perineal tears. The trial is being undertaken at a Danish community hospital with 1,600 yearly deliveries. Data will be analyzed according to the intention-to-treat principle. Recruitment started in January 2013 and the trial is planned to proceed for 24 months. Discussion Most delivery assistance techniques are based on tradition and heritage and lack objective evidence. This trial provides an example of how vaginal delivery techniques can be evaluated in a randomized controlled trial. The results of this trial will clarify the role that delivery of the shoulders has on perineal trauma and thereby provide knowledge to recommendations on birthing technique. Trial registration ClinicalTrials.gov: NCT01937546. PMID:25047001

  12. Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations

    PubMed Central

    Lakoduk, Ashley M.; Priddy, Laurin L.; Yan, Jingsheng; Xie, Xian-Jin

    2015-01-01

    Background. Lack of access to available cancer clinical trials has been cited as a key factor limiting trial accrual, particularly among medically underserved populations. We examined the trends and factors in clinical trial availability within a major U.S. safety-net hospital system. Materials and Methods. We identified cancer clinical trials activated at the Harold C. Simmons Cancer from 1991 to 2014 and recorded the characteristics of the trials that were and were not activated at the Parkland Health and Hospital System satellite site. We used univariate and multivariate logistic regression to determine the association between trial characteristics and nonactivation status, and chi-square analysis to determine the association between the trial characteristics and the reasons for nonactivation. Results. A total of 773 trials were identified, of which 152 (20%) were not activated at Parkland. In multivariable analysis, nonactivation at Parkland was associated with trial year, sponsor, and phase. Compared with the 1991–2006 period, clinical trials in the 2007–2014 period were almost eightfold more likely not to be activated at Parkland. The most common reasons for nonactivation at Parkland were an inability to perform the study procedures (27%) and the startup costs (15%). Conclusion. Over time, in this single-center setting, a decreasing proportion of cancer clinical trials were available to underserved populations. Trial complexity and costs appeared to account for much of this trend. Efforts to overcome these barriers will be key to equitable access to clinical trials, efficient accrual, and the generalizability of the results. Implications for Practice: Despite numerous calls to increase and diversify cancer clinical trial accrual, the present study found that cancer clinical trial activation rates in a safety-net setting for medically underserved populations have decreased substantially in recent years. The principal reasons for study nonactivation were

  13. Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial

    PubMed Central

    Ried-Larsen, Mathias; Karstoft, Kristian; Brinkløv, Cecilie Fau; Brøns, Charlotte; Nielsen, Rasmus Oestergaard; Nielsen, Jens Steen; Vaag, Allan Arthur; Pedersen, Bente Klarlund; Langberg, Henning

    2017-01-01

    Introduction Physical activity is a cornerstone in type 2 diabetes (T2D) rehabilitation. Effective long-term and low-cost strategies to keep these patients' physically active are needed. However, maintaining physical activity behaviour is difficult once formalised interventions end. Structured exercise training supported by mobile technology and remote feedback is potentially an effective strategy. The objective of the trial is to investigate whether mobile health support using the InterWalk application for smartphones is effective in increasing physical activity levels in persons with T2D over time compared with standard care. We investigate whether Interval Walking Training using the InterWalk application is superior to Danish municipality-based rehabilitation in increasing moderate-and-vigorous physical activity levels in patients with T2D across 52 weeks. Secondary, we hypothesise that a motivational programme added from end of intervention to 52 weeks further increases level of physical activity in everyday life in patients with T2D. Methods and analysis The trial is a parallel-group, open-labelled, randomised controlled trial with long-term follow-up at 52 week including patients with T2D. The primary outcome is change in moderate-and-vigorous physical activity. The key secondary outcome includes motivation for physical activity behaviour change. Other secondary outcomes are VO2-peak, strength in the lower extremities. Exclusion criterion is medical contraindication to exercise. We include up to 246 patients and randomly allocate them into a control (standard group) or an experimental group (8–12 weeks of IWT supported by the smartphone-based InterWalk application) in a 1:2 fashion. After intervention, the experimental group is randomly allocated into two follow-up conditions with unsupervised IWT with or without motivational support until 52-week follow-up. The intention-to-treat principle is applied. Ethics and dissemination The local regional

  14. Circuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity: early results from the CIRCIT trial.

    PubMed

    English, Coralie; Bernhardt, Julie; Hillier, Susan

    2014-10-01

    The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown. The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity. Substudy within a large 3-armed randomized controlled trial, which compared 3 different models of physiotherapy service delivery, was provided for 4 weeks during subacute, inpatient rehabilitation (n=283). The duration of all physiotherapy sessions was recorded. In addition, 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 am and 4:30 pm. At each observation, we recorded physical activity, location, and people present. Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time, respectively, when compared with usual care. Participants were standing or walking for a median of 8.2% of observations. On weekdays, circuit class therapy participants spent more time in therapy-related activity (10.2% of observations) when compared with usual care participants (6.1% of observations). On weekends, 7-day therapy participants spent more time in therapy-related activity (4.2% of observations) when compared with both usual care and circuit class therapy participants (0% of observations for both groups). Activity levels outside of therapy sessions did not differ between groups. A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day. http://www.anzctr.org.au/. Unique identifier: ACTRN12610000096055. © 2014 American Heart Association, Inc.

  15. Antihypertensive treatment prolongs tissue plasminogen activator door-to-treatment time: secondary analysis of the INSTINCT trial.

    PubMed

    Skolarus, Lesli E; Scott, Phillip A; Burke, James F; Adelman, Eric E; Frederiksen, Shirley M; Kade, Allison M; Kalbfleisch, Jack D; Ford, Andria L; Meurer, William J

    2012-12-01

    Identifying modifiable tissue plasminogen activator treatment delays may improve stroke outcomes. We hypothesized that prethrombolytic antihypertensive treatment (AHT) may prolong door-to-treatment time (DTT). We performed an analysis of consecutive tissue plasminogen activator-treated patients at 24 randomly selected community hospitals in the Increasing Stroke Treatment through Interventional Behavior Change Tactics (INSTINCT) trial between 2007 and 2010. DTT among stroke patients who received prethrombolytic AHT were compared with those who did not receive prethrombolytic AHT. We then calculated a propensity score for the probability of receiving prethrombolytic AHT using logistic regression with demographics, stroke risk factors, home medications, stroke severity (National Institutes of Health Stroke Scale), onset-to-door time, admission glucose, pretreatment blood pressure, emergency medical service transport, and location at time of stroke as independent variables. A paired t test was performed to compare the DTT between the propensity-matched groups. Of 534 tissue plasminogen activator-treated stroke patients analyzed, 95 received prethrombolytic AHT. In the unmatched cohort, patients who received prethrombolytic AHT had a longer DTT (mean increase, 9 minutes; 95% confidence interval, 2-16 minutes) than patients who did not. After propensity matching, patients who received prethrombolytic AHT had a longer DTT (mean increase, 10.4 minutes; 95% confidence interval, 1.9-18.8) than patients who did not receive prethrombolytic AHT. Prethrombolytic AHT is associated with modest delays in DTT. This represents a potential target for quality-improvement initiatives. Further research evaluating optimum prethrombolytic hypertension management is warranted.

  16. Physical activity measurements affected participants' behavior in a randomized controlled trial.

    PubMed

    van Sluijs, Esther M F; van Poppel, Mireille N M; Twisk, Jos W R; van Mechelen, Willem

    2006-04-01

    Assessing levels and determinants of physical activity as outcome measurements might have an independent effect on participant's physical activity behavior. The objective is to study this effect in a randomized controlled trial (RCT) promoting regular physical activity in Dutch general practice. Using a Solomon four-group design, participants were randomized twice. After randomization to a control or intervention-condition at general practice level (N = 29), participants were randomized to a group participating in measurements at baseline, 2 and 6 months (3M-group, N = 361), or a group only participating in measurements at 6 months (1M-group, N = 356). Outcome measures assessed at 6 months included: level of physical activity (self-reported and objectively measured with accelerometry), meeting ACSM/CDC guideline for regular physical activity, stage of change, and determinants of physical activity. Follow-up data on 635 participants (89%) was collected. Statistically significant measurement effects were found for meeting the ACSM/CDC guideline (self-reported), self-efficacy for resisting relapse, knowledge, and on awareness. Other outcome measures showed positive trends, except stages of change. Measurements of physical activity affect participant's physical activity behavior, possibly triggered by a raised awareness about their own physical activity level. Implications for future research are discussed, as well as methodologic limitations of the study design.

  17. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

    PubMed

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-04

    The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

  18. Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose.

    PubMed

    Loudon, Kirsty; Zwarenstein, Merrick; Sullivan, Frank; Donnan, Peter; Treweek, Shaun

    2013-04-27

    If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention. The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters' subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the PRECIS-2 scores of

  19. Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose

    PubMed Central

    2013-01-01

    Background If you want to know which of two or more healthcare interventions is most effective, the randomised controlled trial is the design of choice. Randomisation, however, does not itself promote the applicability of the results to situations other than the one in which the trial was done. A tool published in 2009, PRECIS (PRagmatic Explanatory Continuum Indicator Summaries) aimed to help trialists design trials that produced results matched to the aim of the trial, be that supporting clinical decision-making, or increasing knowledge of how an intervention works. Though generally positive, groups evaluating the tool have also found weaknesses, mainly that its inter-rater reliability is not clear, that it needs a scoring system and that some new domains might be needed. The aim of the study is to: Produce an improved and validated version of the PRECIS tool. Use this tool to compare the internal validity of, and effect estimates from, a set of explanatory and pragmatic trials matched by intervention. Methods The study has four phases. Phase 1 involves brainstorming and a two-round Delphi survey of authors who cited PRECIS. In Phase 2, the Delphi results will then be discussed and alternative versions of PRECIS-2 developed and user-tested by experienced trialists. Phase 3 will evaluate the validity and reliability of the most promising PRECIS-2 candidate using a sample of 15 to 20 trials rated by 15 international trialists. We will assess inter-rater reliability, and raters’ subjective global ratings of pragmatism compared to PRECIS-2 to assess convergent and face validity. Phase 4, to determine if pragmatic trials sacrifice internal validity in order to achieve applicability, will compare the internal validity and effect estimates of matched explanatory and pragmatic trials of the same intervention, condition and participants. Effect sizes for the trials will then be compared in a meta-regression. The Cochrane Risk of Bias scores will be compared with the

  20. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    PubMed

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  1. Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial

    PubMed Central

    Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

    2015-01-01

    Objectives To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Design Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Setting Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Participants Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Results Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. Conclusions The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. Trial registration numbers NCT02044172; ISRCTN20141297. PMID:26384727

  2. Optimizing Educational Video through Comparative Trials in Clinical Environments

    ERIC Educational Resources Information Center

    Aronson, Ian David; Plass, Jan L.; Bania, Theodore C.

    2012-01-01

    Although video is increasingly used in public health education, studies generally do not implement randomized trials of multiple video segments in clinical environments. Therefore, the specific configurations of educational videos that will have the greatest impact on outcome measures ranging from increased knowledge of important public health…

  3. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    PubMed Central

    van Eijk, Ruben PA; Eijkemans, Marinus JC; Rizopoulos, Dimitris

    2018-01-01

    Objective Amyotrophic lateral sclerosis (ALS) clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1) Cox model; 2) linear mixed effects (LME) model; 3) omnibus test based on Cox and LME models; 4) composite time-to-6-point decrease or death; 5) combined assessment of function and survival (CAFS); and 6) test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point increases false-negative rates among all treatment scenarios. To detect a 15% reduction in ALSFRS-R decline and 34% decline in hazard with 80% power after 18 months, the Cox model requires 524 patients, the LME model 794 patients, the omnibus test 526 patients, the composite end point 1,274 patients, the CAFS 576 patients and the joint model 464 patients. Conclusion Joint models have superior statistical power to analyze simultaneous effects on survival and function and may circumvent pitfalls encountered by other end points. Optimizing trial end points is essential, as selecting suboptimal outcomes may disguise

  4. Enhancing physical activity and reducing obesity through smartcare and financial incentives: A pilot randomized trial.

    PubMed

    Shin, Dong Wook; Yun, Jae Moon; Shin, Jung-Hyun; Kwon, Hyuktae; Min, Hye Yeon; Joh, Hee-Kyung; Chung, Won Joo; Park, Jin Ho; Jung, Kee-Taig; Cho, BeLong

    2017-02-01

    A pilot randomized trial assessed the feasibility and effectiveness of an intervention combining Smartcare (activity tracker with a smartphone application) and financial incentives. A three-arm, open-label randomized controlled trial design involving traditional education, Smartcare, and Smartcare with financial incentives was involved in this study. The latter group received financial incentives depending on the achievement of daily physical activity goals (process incentive) and weight loss targets (outcome incentive). Male university students (N = 105) with body mass index of ≥27 were enrolled. The average weight loss in the traditional education, Smartcare, and Smartcare with financial incentives groups was -0.4, -1.1, and -3.1 kg, respectively, with significantly greater weight loss in the third group (both Ps < 0.01). The final weight loss goal was achieved by 0, 2, and 10 participants in the traditional education, Smartcare, and Smartcare with financial incentives groups (odds ratio for the Smartcare with financial incentive vs. Smartcare = 7.27, 95% confidence interval: 1.45-36.47). Levels of physical activity were significantly higher in this group. The addition of financial incentives to Smartcare was effective in increasing physical activity and reducing obesity. © 2017 The Obesity Society.

  5. Working memory load-dependent spatio-temporal activity of single-trial P3 response detected with an adaptive wavelet denoiser.

    PubMed

    Zhang, Qiushi; Yang, Xueqian; Yao, Li; Zhao, Xiaojie

    2017-03-27

    Working memory (WM) refers to the holding and manipulation of information during cognitive tasks. Its underlying neural mechanisms have been explored through both functional magnetic resonance imaging (fMRI) and electroencephalography (EEG). Trial-by-trial coupling of simultaneously collected EEG and fMRI signals has become an important and promising approach to study the spatio-temporal dynamics of such cognitive processes. Previous studies have demonstrated a modulation effect of the WM load on both the BOLD response in certain brain areas and the amplitude of P3. However, much remains to be explored regarding the WM load-dependent relationship between the amplitude of ERP components and cortical activities, and the low signal-to-noise ratio (SNR) of the EEG signal still poses a challenge to performing single-trial analyses. In this paper, we investigated the spatio-temporal activities of P3 during an n-back verbal WM task by introducing an adaptive wavelet denoiser into the extraction of single-trial P3 features and using general linear model (GLM) to integrate simultaneously collected EEG and fMRI data. Our results replicated the modulation effect of the WM load on the P3 amplitude. Additionally, the activation of single-trial P3 amplitudes was detected in multiple brain regions, including the insula, the cuneus, the lingual gyrus (LG), and the middle occipital gyrus (MOG). Moreover, we found significant correlations between P3 features and behavioral performance. These findings suggest that the single-trial integration of simultaneous EEG and fMRI signals may provide new insights into classical cognitive functions. Copyright © 2017 IBRO. Published by Elsevier Ltd. All rights reserved.

  6. A pilot randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression.

    PubMed

    Uebelacker, Lisa A; Battle, Cynthia L; Sutton, Kaeli A; Magee, Susanna R; Miller, Ivan W

    2016-06-01

    We conducted a pilot randomized controlled trial (RCT) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression. Findings document acceptability and feasibility of the yoga intervention: no yoga-related injuries were observed, instructors showed fidelity to the yoga manual, and women rated interventions as acceptable. Although improvements in depression were not statistically different between groups, they favored yoga. This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy.

  7. Impact of Improving Home Environments on Energy Intake and Physical Activity: A Randomized Controlled Trial

    PubMed Central

    Haardörfer, Regine; Alcantara, Iris C.; Gazmararian, Julie A.; Veluswamy, J. K.; Hodge, Tarccara L.; Addison, Ann R.; Hotz, James A.

    2016-01-01

    Objectives. We assessed the effectiveness of an intervention targeting home food and activity environments to reduce energy intake and increase physical activity among overweight and obese patients from 3 community health centers in rural Georgia. Methods. We conducted a randomized controlled trial (n = 349) from 2011 to 2013, with follow-up at 6 and 12 months. Health coaches delivered the 16-week intervention by using tailored home environment profiles showing areas in need of improvement and positive aspects of the home environment, behavioral contracts for healthy actions, and mailed support materials. Results. Participants were mostly African American women (84.8%), with a mean age of 50.2 years and a mean body mass index (weight in kilograms divided by the square of height in meters) of 38.3. Daily energy intake decreased more for the intervention than control group at 6 (–274 vs –69 kcal) and 12 months (–195 vs –76 kcal). We observed no change for either objective or self-reported physical activity. At 12 months, 82.6% of intervention participants had not gained weight compared with 71.4% of control participants. Conclusions. The intervention was effective in changing home environments and reducing energy intake. PMID:26696290

  8. Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

    PubMed

    Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

    2014-06-01

    Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

  9. The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

    PubMed

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; Ray, Kathryn J; Zegans, Michael E; McLeod, Stephen D; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M

    2013-04-01

    To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Voriconazole should not be used as monotherapy in filamentous keratitis. clinicaltrials.gov Identifier: NCT00996736

  10. Economic evaluation of the randomized European Achalasia trial comparing pneumodilation with Laparoscopic Heller myotomy.

    PubMed

    Moonen, A; Busch, O; Costantini, M; Finotti, E; Tack, J; Salvador, R; Boeckxstaens, G; Zaninotto, G

    2017-11-01

    A recent multicenter randomized trial in achalasia patients has shown that pneumatic dilation resulted in equivalent relief of symptoms compared to laparoscopic Heller myotomy. Additionally, the cost of each treatment should be also taken in consideration. Therefore, the aim of the present study was to perform an economic analysis of the European achalasia trial. Patients with newly diagnosed achalasia were enrolled from to 2003 to 2008 in 14 centers in five European countries and were randomly assigned to either pneumatic dilation (PD) or laparoscopic Heller (LHM). The economic analysis was performed in the three centers in three different countries where most patients were enrolled (Amsterdam [NL], Leuven, [B] and Padova [I]) and then applied to all patients included in the study. The total raw costs of the two treatments per patient include the initial costs, the costs of complications, and the costs of retreatments. Two hundred and one patients, 107 (57 males and 50 females, mean age 46 CI: 43-49 years) were randomized to LHM and 94 (59 males and 34 females, mean age 46 CI 43-50 years) to PD. The total cost of PD per patient was quite comparable in the three different centers; €3397 in Padova, €3259 in Amsterdam and €3792 in Leuven. For LHM, the total costs per patient were highest in Amsterdam: €4488 in Padova, €6720 in Amsterdam, and €5856 in Leuven. In conclusion, the strategy of treating achalasia starting with PD appears the most economic approach, independent of the health system. © 2017 John Wiley & Sons Ltd.

  11. Active video games as a tool to prevent excessive weight gain in adolescents: rationale, design and methods of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Excessive body weight, low physical activity and excessive sedentary time in youth are major public health concerns. A new generation of video games, the ones that require physical activity to play the games –i.e. active games- may be a promising alternative to traditional non-active games to promote physical activity and reduce sedentary behaviors in youth. The aim of this manuscript is to describe the design of a study evaluating the effects of a family oriented active game intervention, incorporating several motivational elements, on anthropometrics and health behaviors in adolescents. Methods/Design The study is a randomized controlled trial (RCT), with non-active gaming adolescents aged 12 – 16 years old randomly allocated to a ten month intervention (receiving active games, as well as an encouragement to play) or a waiting-list control group (receiving active games after the intervention period). Primary outcomes are adolescents’ measured BMI-SDS (SDS = adjusted for mean standard deviation score), waist circumference-SDS, hip circumference and sum of skinfolds. Secondary outcomes are adolescents’ self-reported time spent playing active and non-active games, other sedentary activities and consumption of sugar-sweetened beverages. In addition, a process evaluation is conducted, assessing the sustainability of the active games, enjoyment, perceived competence, perceived barriers for active game play, game context, injuries from active game play, activity replacement and intention to continue playing the active games. Discussion This is the first adequately powered RCT including normal weight adolescents, evaluating a reasonably long period of provision of and exposure to active games. Next, strong elements are the incorporating motivational elements for active game play and a comprehensive process evaluation. This trial will provide evidence regarding the potential contribution of active games in prevention of excessive weight gain in

  12. A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

    PubMed

    Wang, Chenchen; McAlindon, Timothy; Fielding, Roger A; Harvey, William F; Driban, Jeffrey B; Price, Lori Lyn; Kalish, Robert; Schmid, Anna; Scott, Tammy M; Schmid, Christopher H

    2015-01-30

    Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ≥21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short

  13. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    PubMed

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  14. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-01-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating…

  15. Face washing promotion for preventing active trachoma

    PubMed Central

    Ejere, Henry OD; Alhassan, Mahmoud B; Rabiu, Mansur

    2015-01-01

    Background Trachoma remains a major cause of avoidable blindness among underprivileged populations in many developing countries. It is estimated that about 146 million people have active trachoma and nearly six million people are blind due to complications associated with repeat infections. Objectives The objective of this review was to assess the effects of face washing promotion for the prevention of active trachoma in endemic communities. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2015, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to January 2015), EMBASE (January 1980 to January 2015), PubMed (January 1948 to January 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to January 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (accessed 10 January 2014), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 26 January 2015. To identify further relevant trials we checked the reference lists of the included trials. Also, we used the Science Citation Index to search for references to publications that cited the trials included in the review. We contacted investigators and experts in the field to identify additional trials. Selection criteria We included randomized controlled trials (RCTs) or quasi-RCTs that compared face washing with no treatment or face washing combined with antibiotics against antibiotics alone. Trial participants were residents of endemic trachoma communities. Data collection and analysis Two review authors independently extracted data and assessed trial quality. We contacted trial

  16. Short-term transcutaneous electrical nerve stimulation reduces pain and improves the masticatory muscle activity in temporomandibular disorder patients: a randomized controlled trial.

    PubMed

    Ferreira, Ana Paula de Lima; Costa, Dayse Regina Alves da; Oliveira, Ana Izabela Sobral de; Carvalho, Elyson Adam Nunes; Conti, Paulo César Rodrigues; Costa, Yuri Martins; Bonjardim, Leonardo Rigoldi

    2017-01-01

    To investigate the short-term effect of transcutaneous electrical nerve stimulation (TENS) by examining pain intensity, pressure pain threshold (PPT) and electromyography (EMG) activity in patients with temporomandibular disorder (TMD). Forty patients with myofascial TMD were enrolled in this randomized placebo-controlled trial and were divided into two groups: active (n=20) and placebo (n=20) TENS. Outcome variables assessed at baseline (T0), immediately after (T2) and 48 hours after treatment (T1) were: pain intensity with the aid of a visual analogue scale (VAS); PPT of masticatory and cervical structures; EMG activity during mandibular rest position (MR), maximal voluntary contraction (MVC) and habitual chewing (HC). Two-way ANOVA for repeated measures was applied to the data and the significance level was set at 5%. There was a decrease in the VAS values at T1 and T2 when compared with T0 values in the active TENS group (p<0.050). The PPT between-group differences were significant at T1 assessment of the anterior temporalis and sternocleidomastoid (SCM) and T2 for the masseter and the SCM (p<0.050). A significant EMG activity reduction of the masseter and anterior temporalis was presented in the active TENS during MR at T1 assessment when compared with T0 (p<0.050). The EMG activity of the anterior temporalis was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050). The EMG activity of the masseter and anterior temporalis muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050). The short-term therapeutic effects of TENS are superior to those of the placebo, because of reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement.

  17. A Randomized Comparative Trial on the Therapeutic Efficacy of Topical Aloe vera and Calendula officinalis on Diaper Dermatitis in Children

    PubMed Central

    Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2012-01-01

    Introduction. Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of Aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Methods. Sixty-six infants with DD (aged < 3 years) were randomized to receive either Aloe cream (n = 32) or Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Results. Although improvement in the severity of DD was observed in both treatment groups (P < 0.001), patients receiving Calendula ointment had significantly fewer rash sites compared to Aloe group (P = 0.001). No adverse effect was reported from either of the medications. Discussion. The evidence from this study suggests that topical Aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants. PMID:22606064

  18. Advice to stay active as a single treatment for low back pain and sciatica.

    PubMed

    Hilde, G; Hagen, K B; Jamtvedt, G; Winnem, M

    2002-01-01

    Low back pain is one of the most common conditions managed in primary care. Restricted activity, rest, and symptomatic analgesics are the most commonly prescribed treatment for low back pain and sciatica. To assess the effects of advice to stay active as single treatment for patients with low back pain. Computerised searches in MEDLINE, EMBASE, Sport, The Cochrane Controlled Trials Register, Musculoskeletal Group's Trials Register and Scisearch, and scanning of reference lists from relevant articles were undertaken. Relevant studies were also traced by contacting authors. Date of the most recent searches: December 1998. We included all randomised trials or quasi-randomised trials where the study population consisted of adult patients with low back pain or sciatica, in which one comparison group was advised to stay active. The main outcomes of interest were pain, functional status, recovery and return to work. Two reviewers independently selected trials for inclusion, assessed the validity of included trials and extracted data. Investigators were contacted to collect missing data or for clarification when needed. Four trials, with a total of 491 patients, were included. Advice to stay active was compared to advice to rest in bed in all trials. Two trials were assessed to have low risk of bias and two to have moderate to high risk of bias. The results were heterogeneous. Results from one high quality trial of patients with acute simple LBP found small differences in functional status [Weighted Mean Difference (on a 0-100 scale) 6.0 (95% CI: 1.5, 10.5)] and length of sick leave [WMD 3.4 days (95% CI: 1.6, 5.2)] in favour of staying active compared to advice to stay in bed for two days. The other high quality trial compared advice to stay active with advice to rest in bed for 14 days for patients with sciatic syndrome, and found no differences between the groups. One of the high quality trials also compared advice to stay active with exercises for patients with acute

  19. Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals.

    PubMed

    McNair, Angus G K; Brookes, Sara T; Whistance, Robert N; Forsythe, Rachael O; Macefield, Rhiannon; Rees, Jonathan; Jones, James; Smith, George; Pullyblank, Anne M; Avery, Kerry N L; Thomas, Michael G; Sylvester, Paul A; Russell, Anne; Oliver, Alfred; Morton, Dion; Kennedy, Robin; Jayne, David G; Huxtable, Richard; Hackett, Rowland; Dutton, Susan J; Coleman, Mark G; Card, Mia; Brown, Julia; Blazeby, Jane M

    2016-07-25

    Trials are robust sources of data for clinical practice; however, trial outcomes may not reflect what is important to communicate for decision-making. The study compared clinicians' views of outcomes to include in a core outcome set for colorectal cancer (CRC) surgery, with what clinicians considered important information for clinical practice (core information). Potential outcome/information domains were identified through systematic literature reviews, reviews of hospital information leaflets and interviews with patients. These were organized into six categories and used to design a questionnaire survey that asked surgeons and nurses from a sample of CRC centers to rate the importance of each domain as an outcome or as information on a nine-point Likert scale. Respondents were re-surveyed (round 2) following group feedback (Delphi methods). Comparisons were made by calculating the difference in mean scores between the outcomes and information domains, and paired t tests were used to explore the difference between mean scores of the six outcome/information categories. Data sources identified 1216 outcome/information items for CRC surgery that informed a 94-item questionnaire. First-round questionnaires were returned from 63/81 (78 %) of centers. Clinicians rated 76/94 (84 %) domains of higher importance to measure in trials than information to communicate to patients in round 1. This was reduced to 24/47 (51 %) in round 2. The greatest difference was evident in domains regarding survival, which was rated much more highly as a trial outcome than an important piece of information for decision-making (difference in mean 2.3, 95 % CI 1.9 to 2.8, p <0.0001). Specific complications and quality-of-life domains were rated similarly (difference in mean 0.18, 95 % CI -0.1 to 0.4, p = 0.2 and difference in mean 0.2, 95 % CI -0.1 to 0.5, p = 0.2, respectively). Whilst clinicians want to measure key outcomes in trials, they rate these as less important to

  20. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    PubMed

    Ross, Joseph S; Mulvey, Gregory K; Hines, Elizabeth M; Nissen, Steven E; Krumholz, Harlan M

    2009-09-01

    ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006). Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements

  1. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    PubMed Central

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  2. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial.

    PubMed

    Barba, Elizabeth; Accarino, Anna; Azpiroz, Fernando

    2017-12-01

    Abdominal distention is produced by abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. We performed a randomized, placebo-controlled study to demonstrate the superiority of biofeedback to placebo for the treatment of abdominal distention. At a referral center in Spain, we enrolled consecutive patients with visible abdominal distention who fulfilled the Rome III criteria for functional intestinal disorders (47 women, 1 man; 21-74 years old); 2 patients assigned to the placebo group withdrew and 2 patients assigned to biofeedback were not valid for analysis. Abdominothoracic muscle activity was recorded by electromyography. The patients in the biofeedback group were shown the signal and instructed to control muscle activity, whereas patients in the placebo received no instructions and were given oral simethicone. Each patient underwent 3 sessions over a 10-day period. The primary outcomes were subjective sensation of abdominal distention, measured by graphic rating scales for 10 consecutive days before and after the intervention. Patients in the biofeedback group effectively learned to reduce intercostal activity (by a mean 45% ± 3%), but not patients in the placebo group (reduced by a mean 5% ± 2%; P < .001). Patients in the biofeedback group learned to increase anterior wall muscle activity (by a mean 101% ± 10%), but not in the placebo group (decreased by a mean 4% ± 2%; P < .001). Biofeedback resulted in a 56% ± 1% reduction of abdominal distention (from a mean score of 4.6 ± 0.2 to 2.0 ± 0.2), whereas patients in the placebo group had a reduction of only 13% ± 8% (from a mean score of 4.7 ± 0.1 to 4.1 ± 0.4) (P < .001). In a randomized trial of patients with a functional intestinal disorder, we found that abdominal distention can be effectively corrected by biofeedback-guided control of abdominothoracic muscular activity, compared with placebo

  3. A Randomized Controlled Trial Comparing Botulinum Toxin A Dosage in the Upper Extremity of Children with Spasticity

    ERIC Educational Resources Information Center

    Kawamura, Anne; Campbell, Kent; Lam-Damji, Sophie; Fehlings, Darcy

    2007-01-01

    This study compared the effects of low and high doses of botulinum toxin A (BTX-A) to improve upper extremity function. Thirty-nine children (22 males, 17 females) with a mean age of 6 years 2 months (SD 2y 9mo) diagnosed with spastic hemiplegia or triplegia were enrolled into this double-blind, randomized controlled trial. The high-dose group…

  4. Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

    PubMed

    Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

    2017-03-01

    To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

  5. Promoting Physical Activity With the Out of School Nutrition and Physical Activity (OSNAP) Initiative: A Cluster-Randomized Controlled Trial.

    PubMed

    Cradock, Angie L; Barrett, Jessica L; Giles, Catherine M; Lee, Rebekka M; Kenney, Erica L; deBlois, Madeleine E; Thayer, Julie C; Gortmaker, Steven L

    2016-02-01

    Millions of children attend after-school programs in the United States. Increasing physical activity levels of program participants could have a broad effect on children's health. To test the effectiveness of the Out of School Nutrition and Physical Activity (OSNAP) Initiative in increasing children's physical activity levels in existing after-school programs. Cluster-randomized controlled trial with matched program pairs. Baseline data were collected September 27 through November 12, 2010, with follow-up data collected April 25 through May 27, 2011. The dates of our analysis were March 11, 2014, through August 18, 2015. The setting was 20 after-school programs in Boston, Massachusetts. All children 5 to 12 years old in participating programs were eligible for study inclusion. Ten programs participated in a series of three 3-hour learning collaborative workshops, with additional optional opportunities for training and technical assistance. Change in number of minutes and bouts of moderate to vigorous physical activity, vigorous physical activity, and sedentary activity and change in total accelerometer counts between baseline and follow-up. Participants with complete data were 402 racially/ethnically diverse children, with a mean age of 7.7 years. Change in the duration of physical activity opportunities offered to children during program time did not differ between conditions (-1.2 minutes; 95% CI, -14.2 to 12.4 minutes; P = .87). Change in moderate to vigorous physical activity minutes accumulated by children during program time did not differ significantly by intervention status (-1.0; 95% CI, -3.3 to 1.3; P = .40). Total minutes per day of vigorous physical activity (3.2; 95% CI, 1.8-4.7; P < .001), vigorous physical activity minutes in bouts (4.1; 95% CI, 2.7-5.6; P < .001), and total accelerometer counts per day (16,894; 95% CI, 5101-28,686; P = .01) increased significantly during program time among intervention participants compared with control

  6. Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background The need for cost-effective interventions for people suffering from major depressive disorders is essential. Behavioral activation is an intervention that can largely benefit from the use of new mobile technologies (for example smartphones). Therefore, developing smartphone-based behavioral activation interventions might be a way to develop cost-effective treatments for people suffering from major depressive disorders. The aim of this study will be to test the effects of a smartphone-delivered behavioral activation treatment. Methods The study will be a randomized controlled trial with a sample size of 120 participants, with 60 patients in each group. The treatment group includes an 8-week smartphone-based behavioral activation intervention, with minimal therapist contact. The smartphone-based intervention consists of a web-based psychoeducation, and a smartphone application. There is also a back-end system where the therapist can see reports from the patients or activities being reported. In the attention control group, we will include brief online education and then recommend use of a smartphone application that is not directly aimed at depression (for example, ‘Effective meditation’). The duration of the control condition will also be 8 weeks. For ethical reasons we will give the participants in the control group access to the behavioral activation treatment following the 8-week treatment period. Discussions We believe that this trial has at least three important implications. First, we believe that smartphones can be integrated even further into society and therefore may serve an important role in health care. Second, while behavioral activation is a psychological treatment approach for which there is empirical support, the use of a smartphone application could serve as the therapist’s prolonged arm into the daily life of the patient. Third, as we have been doing trials on guided Internet treatment for more than 10 years it is now time to

  7. The functional organization of trial-related activity in lexical processing after early left hemispheric brain lesions: An event-related fMRI study.

    PubMed

    Fair, Damien A; Choi, Alexander H; Dosenbach, Yannic B L; Coalson, Rebecca S; Miezin, Francis M; Petersen, Steven E; Schlaggar, Bradley L

    2010-08-01

    Children with congenital left hemisphere damage due to perinatal stroke are capable of acquiring relatively normal language functions despite experiencing a cortical insult that in adults often leads to devastating lifetime disabilities. Although this observed phenomenon is accepted, its neurobiological mechanisms are not well characterized. In this paper we examined the functional neuroanatomy of lexical processing in 13 children/adolescents with perinatal left hemispheric damage. In contrast to many previous perinatal infarct fMRI studies, we used an event-related design, which allowed us to isolate trial-related activity and examine correct and error trials separately. Using both group and single subject analysis techniques we attempt to address several methodological factors that may contribute to some discrepancies in the perinatal lesion literature. These methodological factors include making direct statistical comparisons, using common stereotactic space, using both single subject and group analyses, and accounting for performance differences. Our group analysis, investigating correct trial-related activity (separately from error trials), showed very few statistical differences in the non-involved right hemisphere between patients and performance matched controls. The single subject analysis revealed atypical regional activation patterns in several patients; however, the location of these regions identified in individual patients often varied across subjects. These results are consistent with the idea that alternative functional organization of trial-related activity after left hemisphere lesions is in large part unique to the individual. In addition, reported differences between results obtained with event-related designs and blocked designs may suggest diverging organizing principles for sustained and trial-related activity after early childhood brain injuries. 2009 Elsevier Inc. All rights reserved.

  8. Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma

    PubMed Central

    Erwin, Kim; Martin, Molly A; Flippin, Tara; Norell, Sarah; Shadlyn, Ariana; Yang, Jie; Falco, Paula; Rivera, Jaime; Ignoffo, Stacy; Kumar, Rajesh; Margellos-Anast, Helen; McDermott, Michael; McMahon, Kate; Mosnaim, Giselle; Nyenhuis, Sharmilee M; Press, Valerie G; Ramsay, Jessica E; Soyemi, Kenneth; Thompson, Trevonne M; Krishnan, Jerry A

    2016-01-01

    Aim: To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. Methods: We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: define design requirements; prototype and refine; and evaluate. Results: Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool over current tools. Conclusion: Engaging end-users in contextual inquiry resulted in CAPE (CHICAGO Action Plan after ED discharge), a new stakeholder-balanced discharge tool, which is being tested in a multicenter comparative effectiveness trial. PMID:26690579

  9. How conservative is Fisher's exact test? A quantitative evaluation of the two-sample comparative binomial trial.

    PubMed

    Crans, Gerald G; Shuster, Jonathan J

    2008-08-15

    The debate as to which statistical methodology is most appropriate for the analysis of the two-sample comparative binomial trial has persisted for decades. Practitioners who favor the conditional methods of Fisher, Fisher's exact test (FET), claim that only experimental outcomes containing the same amount of information should be considered when performing analyses. Hence, the total number of successes should be fixed at its observed level in hypothetical repetitions of the experiment. Using conditional methods in clinical settings can pose interpretation difficulties, since results are derived using conditional sample spaces rather than the set of all possible outcomes. Perhaps more importantly from a clinical trial design perspective, this test can be too conservative, resulting in greater resource requirements and more subjects exposed to an experimental treatment. The actual significance level attained by FET (the size of the test) has not been reported in the statistical literature. Berger (J. R. Statist. Soc. D (The Statistician) 2001; 50:79-85) proposed assessing the conservativeness of conditional methods using p-value confidence intervals. In this paper we develop a numerical algorithm that calculates the size of FET for sample sizes, n, up to 125 per group at the two-sided significance level, alpha = 0.05. Additionally, this numerical method is used to define new significance levels alpha(*) = alpha+epsilon, where epsilon is a small positive number, for each n, such that the size of the test is as close as possible to the pre-specified alpha (0.05 for the current work) without exceeding it. Lastly, a sample size and power calculation example are presented, which demonstrates the statistical advantages of implementing the adjustment to FET (using alpha(*) instead of alpha) in the two-sample comparative binomial trial. 2008 John Wiley & Sons, Ltd

  10. Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial.

    PubMed

    Alley, Stephanie; Jennings, Cally; Plotnikoff, Ronald C; Vandelanotte, Corneel

    2016-08-12

    engagement (110 minutes spent on the website vs 78 minutes, P=.02) compared with other participants. There were no overall retention, adherence, engagement, and satisfaction differences between tailoring + video-coaching and tailoring-only participants. At 9 weeks, physical activity increased from baseline to postintervention in all groups (tailoring + video-coaching: +150 minutes/week; tailoring only: +123 minutes/week; waitlist control: +34 minutes/week). The increase was significantly higher in the tailoring + video-coaching group compared with the control group (P=.01). No significant difference was found between intervention groups and no significant between-group differences were found for physical activity change at 6 months. Only small improvements were observed when video-coaching was added to computer-tailored advice in a Web-based physical activity intervention. However, combined Web-based video-coaching and computer-tailored advice was effective in comparison with a control group. More research is needed to determine whether Web-based coaching is more effective than stand-alone computer-tailored advice. Australian New Zealand Clinical Trials Registry (ACTRN): 12614000339651; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614000339651+&isBasic=True (Archived by WebCite at http://www.webcitation.org/6jTnOv0Ld).

  11. Comparative evaluation of terminalia chebula extract mouthwash and chlorhexidine mouthwash on plaque and gingival inflammation - 4-week randomised control trial.

    PubMed

    Gupta, Devanand; Gupta, Rajendra Kumar; Bhaskar, Dara John; Gupta, Vipul

    2015-01-01

    The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine (CHX 0.2%) and distilled water as control (placebo). A double-blind randomised control trial was conducted among undergraduate students who volunteered. They were randomly allocated into three study groups: 1) Terminalia chebula mouthwash (n = 30); 2) chlorhexidine (active control) (n = 30); 3) distilled water (placebo) (n = 30). Assessment was carried out according to plaque score and gingival score. Statistical analysis was carried out to compare the effect of both mouthwashes. ANOVA and post-hoc LSD tests were performed using SPSS version 17 with p ≤ 0.05 considered statistically significant. Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation. The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to the placebo. The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash. Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter.

  12. Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.

    PubMed

    Hackshaw-McGeagh, Lucy; Lane, J Athene; Persad, Raj; Gillatt, David; Holly, Jeff M P; Koupparis, Anthony; Rowe, Edward; Johnston, Lyndsey; Cloete, Jenny; Shiridzinomwa, Constance; Abrams, Paul; Penfold, Chris M; Bahl, Amit; Oxley, Jon; Perks, Claire M; Martin, Richard

    2016-03-07

    A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures. The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation). The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity

  13. Evaluation of an integrated treatment for active duty service members with comorbid posttraumatic stress disorder and major depressive disorder: Study protocol for a randomized controlled trial.

    PubMed

    Walter, Kristen H; Glassman, Lisa H; Michael Hunt, W; Otis, Nicholas P; Thomsen, Cynthia J

    2018-01-01

    Posttraumatic stress disorder (PTSD) commonly co-occurs with major depressive disorder (MDD) in both civilian and military/veteran populations. Existing, evidence-based PTSD treatments, such as cognitive processing therapy (CPT), often reduce symptoms of both PTSD and depression; however, findings related to the influence of comorbid MDD on PTSD treatment outcomes are mixed, and few studies use samples of individuals with both conditions. Behavioral activation (BA), an approach that relies on behavioral principles, is an effective treatment for depression. We have integrated BA into CPT (BA+CPT), a more cognitive approach, to address depressive symptoms among active duty service members with both PTSD and comorbid MDD. We describe an ongoing randomized controlled trial investigating the efficacy of our innovative, integrated BA+CPT intervention, compared with standard CPT, for active duty service members with PTSD and comorbid MDD. We detail the development of this integrated treatment, as well as the design and implementation of the randomized controlled trial, to evaluate its effect on symptoms. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women.

    PubMed

    Ayeleke, Reuben Olugbenga; Hay-Smith, E Jean C; Omar, Muhammad Imran

    2015-11-03

    Pelvic floor muscle training (PFMT) is a first-line conservative treatment for urinary incontinence in women. Other active treatments include: physical therapies (e.g. vaginal cones); behavioural therapies (e.g. bladder training); electrical or magnetic stimulation; mechanical devices (e.g. continence pessaries); drug therapies (e.g. anticholinergics (solifenacin, oxybutynin, etc.) and duloxetine); and surgical interventions including sling procedures and colposuspension. This systematic review evaluated the effects of adding PFMT to any other active treatment for urinary incontinence in women To compare the effects of pelvic floor muscle training combined with another active treatment versus the same active treatment alone in the management of women with urinary incontinence. We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 5 May 2015), and CINAHL (January 1982 to 6 May 2015), and the reference lists of relevant articles. We included randomised or quasi-randomised trials with two or more arms, of women with clinical or urodynamic evidence of stress urinary incontinence, urgency urinary incontinence or mixed urinary incontinence. One arm of the trial included PFMT added to another active treatment; the other arm included the same active treatment alone. Two review authors independently assessed trials for eligibility and methodological quality and resolved any disagreement by discussion or consultation with a third party. We extracted and processed data in accordance with the Cochrane Handbook for Systematic Reviews of Interventions. Other potential sources of bias we incorporated into the 'Risk of bias' tables were ethical approval, conflict of interest and funding source. Thirteen trials met the inclusion criteria

  15. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563)

    PubMed Central

    2014-01-01

    Background Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients’ short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. Methods/design Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically

  16. Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials

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

    Mishra, Mark V., E-mail: mmishra@umm.edu; Aggarwal, Sameer; Bentzen, Soren M.

    Purpose: To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Methods and Materials: Active PBT clinical trials were identified from (clinicaltrials.gov) and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. Results: A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% ofmore » trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. Conclusions: The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities.« less

  17. Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

    PubMed

    Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

    2017-07-11

    The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical

  18. A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

    PubMed

    Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

    2018-01-01

    This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

  19. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

    PubMed Central

    Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

    2015-01-01

    Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

  20. Exercise videogames for physical activity and fitness: Design and rationale of the Wii Heart Fitness trial.

    PubMed

    Bock, Beth C; Thind, Herpreet; Dunsiger, Shira I; Serber, Eva R; Ciccolo, Joseph T; Cobb, Victoria; Palmer, Kathy; Abernathy, Sean; Marcus, Bess H

    2015-05-01

    Despite numerous health benefits, less than half of American adults engage in regular physical activity. Exercise videogames (EVG) may be a practical and attractive alternative to traditional forms of exercise. However there is insufficient research to determine whether EVG play alone is sufficient to produce prolonged engagement in physical activity or improvements in cardiovascular fitness and overall health risk. The goal of the present study is to test the efficacy of exercise videogames to increase time spent in moderate to vigorous physical activity (MVPA) and to improve cardiovascular risk indices among adults. Wii Heart Fitness is a rigorous 3-arm randomized controlled trial with adults comparing three 12-week programs: (1) supervised EVGs, (2) supervised standard exercise, and (3) a control condition. Heart rate is monitored continuously throughout all exercise sessions. Assessments are conducted at baseline, end of intervention (week 12), 6 and 9 months. The primary outcome is time spent in MVPA physical activity. Secondary outcomes include changes in cardiovascular fitness, body composition, blood lipid profiles and maintenance of physical activity through six months post-treatment. Changes in cognitive and affective constructs derived from Self Determination and Social Cognitive Theories will be examined to explain the differential outcomes between the two active treatment conditions. The Wii Heart Fitness study is designed to test whether regular participation in EVGs can be an adequate source of physical activity for adults. This study will produce new data on the effect of EVGs on cardiovascular fitness indices and prolonged engagement with physical activity. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.

    PubMed

    Shepherd, Deborah M; Jahnke, Heidi; White, William L; Little, Andrew S

    2018-02-01

    OBJECTIVE Pain control is an important clinical consideration and quality-of-care metric. No studies have examined postoperative pain control following transsphenoidal surgery for pituitary lesions. The study goals were to 1) report postoperative pain scores following transsphenoidal surgery, 2) determine if multimodal opioid-minimizing pain regimens yielded satisfactory postoperative pain control, and 3) determine if intravenous (IV) ibuprofen improved postoperative pain scores and reduced opioid use compared with placebo. METHODS This study was a single-center, randomized, double-blinded, placebo-controlled intervention trial involving adult patients with planned transsphenoidal surgery for pituitary tumors randomized into 2 groups. Group 1 patients were treated with scheduled IV ibuprofen, scheduled oral acetaminophen, and rescue opioids. Group 2 patients were treated with IV placebo, scheduled oral acetaminophen, and rescue opioids. The primary end point was patient pain scores (visual analog scale [VAS], rated 0-10) for 48 hours after surgery. The secondary end point was opioid use as estimated by oral morphine equivalents (OMEs). RESULTS Of 136 patients screened, 62 were enrolled (28 in Group 1, 34 in Group 2). The study was terminated early because the primary and secondary end points were reached. Baseline characteristics between groups were well matched except for age (Group 1, 59.3 ± 14.4 years; Group 2, 49.8 ± 16.2 years; p = 0.02). Mean VAS pain scores were significantly different, with a 43% reduction in Group 1 (1.7 ± 2.2) compared with Group 2 (3.0 ± 2.8; p < 0.0001). Opioid use was significantly different, with a 58% reduction in Group 1 (26.3 ± 28.7 mg OME) compared with Group 2 (62.5 ± 63.8 mg OME; p < 0.0001). CONCLUSIONS Multimodal opioid-minimizing pain-management protocols resulted in acceptable pain control following transsphenoidal surgery. IV ibuprofen resulted in significantly improved pain scores and significantly decreased opioid

  2. Comparing vaccines: a systematic review of the use of the non-inferiority margin in vaccine trials.

    PubMed

    Donken, R; de Melker, H E; Rots, N Y; Berbers, G; Knol, M J

    2015-03-17

    Non-inferiority (NI) randomized controlled trials (RCTs) aim to demonstrate that a new treatment is no worse than a comparator that has already shown its efficacy over placebo within a pre-specified margin. However, clear guidelines on how the NI margin should be determined are lacking for vaccine trials. A difference (seroprevalence/risk) of 10% or a geometric mean titre/concentration (GMT) ratio of 1.5 or 2.0 in antibody levels is implicitly recommended for vaccine trials. We aimed to explore which NI margins were used in vaccine RCTs and how they were determined. A systematic search for NI vaccine RCTs yielded 177 eligible articles. Data were extracted from these articles using a standardized form and included general characteristics and characteristics specific for NI trials. Relations between the study characteristics and the NI margin used were explored. Among the 143 studies using an NI margin based on difference (n=136 on immunogenicity, n=2 on efficacy and n=5 on safety), 66% used a margin of 10%, 23% used margins lower than 10% (range 1-7.5%) and 11% used margins larger than 10% (range 11.5-25%). Of the 103 studies using a NI margin based on the GMT ratio, 50% used a margin of 0.67/1.5 and 49% used 0.5/2.0. As observed, 85% of the studies did not discuss the method of margin determination; and 19% of the studies lacked a confidence interval or p-value for non-inferiority. Most NI vaccine RCTs used an NI margin of 10% for difference or a GMT ratio of 1.5 or 2.0 without a clear rationale. Most articles presented enough information for the reader to make a judgement about the NI margin used and the conclusions. The reporting on the design, margins used and results of NI vaccine trials could be improved; more explicit guidelines may help to achieve this end. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  4. ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials.

    PubMed

    Galasko, Douglas; Bennett, David A; Sano, Mary; Marson, Daniel; Kaye, Jeff; Edland, Steven D

    2006-01-01

    In primary prevention trials for Alzheimer disease, the inception cohort typically has normal or minimally impaired complex activities of daily living (ADL). ADL change during a trial could trigger detailed evaluation or serve as an outcome measure. A brief, easily administered, and reliable ADL rating scale would assist prevention studies. To develop an ADL scale for prevention trials that allows self-rating or completion by informants. The Activities of Daily Living-Prevention Instrument (ADL-PI) was developed, comprising 15 ADL and 5 physical function questions. Six hundred forty-four elderly subjects participating in the Prevention Instrument Project completed a self-rated version of the ADL-PI, and informants for 632 subjects completed an informant version. Informants also completed a Mild Cognitive Impairment (MCI) ADL questionnaire to allow comparisons. Subjects performed well on all ADL scales at baseline. Completion of the ADL-PI questionnaires at home or in-clinic yielded comparable information. Scores from baseline to 3 months had good reliability. The ADL-PI, obtained from either self-report or informants, discriminated between subjects rated as CDR 0 and CDR 0.5. Subjects with worse baseline cognitive performance also had slightly worse ADL-PI scores. Preliminary analysis indicates that subjects who triggered cognitive evaluations had slightly lower baseline ADL-PI scores by both self and informant reports. The ADL-PI can be completed at home or in clinic, and has adequate reliability. The utility of self-administered and informant versions and predictive value of reported deficits requires further follow-up.

  5. Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial.

    PubMed

    Becoña, Elisardo; Martínez-Vispo, Carmela; Senra, Carmen; López-Durán, Ana; Rodríguez-Cano, Rubén; Fernández Del Río, Elena

    2017-04-08

    Smoking is an important risk factor for mental health-related problems. Numerous studies have supported a bi-directional association between cigarette smoking and depression. Despite the advances in understanding the comorbidity between both problems, the most effective psychological treatment that simultaneously targets smoking and depressive symptomatology remains unclear. The objective of this study is to assess the effectiveness of a cognitive-behavioral intervention for smoking cessation with components of behavioral activation for managing depressed mood. A single blind, three-arm, superiority randomized controlled trial is proposed. Participants will be smokers over 18 years old, who smoke at least 8 cigarettes per day. Participants will be randomized to one of three conditions, using a 2:2:1 allocation ratio: 1) standard cognitive-behavioral smoking cessation treatment; 2) standard cognitive-behavioral smoking cessation treatment plus behavioral activation; or 3) a three-month delayed treatment control group. The primary outcome measures will be biochemically verified point-prevalence abstinence (carbon monoxide in expired air) and significant change from baseline in depressive symptoms to the end of treatment, and at the 3-, 6-, and 12-month follow-up. This study aims to assess the efficacy of a cognitive-behavioral intervention with behavioral activation components for smoking cessation and depressive symptoms, compared to a standard cognitive-behavioral intervention to quit smoking. As the relation between depressive symptoms, even at subclinical levels, and quitting smoking difficulties is well known, we expect that such intervention will allow obtaining higher abstinence rates, lower relapse rates, and mood improvement. ClinicalTrials.gov : NCT02844595 . Retrospectively registered 19th July, 2016. The study started in January 2016, and the recruitment is ongoing.

  6. Pilot randomized trial of a volitional help sheet-based tool to increase leisure time physical activity in breast cancer survivors.

    PubMed

    Chapman, Janine; Fletcher, Chloe; Flight, Ingrid; Wilson, Carlene

    2018-05-16

    To develop and test a volitional help sheet-based tool to improve physical activity in breast cancer survivors compared to a standard self-generated implementation intention intervention. Pilot randomized trial conducted online over 3 months. Participants were randomized to an online volitional help sheet (n = 50) or implementation intention (n = 51) intervention. Measures were taken at baseline, 1 and 3 months. The main outcome measure was moderate-strenuous leisure time physical activity. Secondary outcomes were health-related quality of life and mood. Participants exposed to the volitional help sheet and implementation intention interventions showed similar effects after 1 month, with both groups reporting a significant increase in moderate-strenuous physical activity. After 3 months, the initial increase in physical activity was maintained by the volitional help sheet group, but not the implementation intention group. Improvements were also found for negative affect and emotional quality of life. While both interventions show promise in promoting physical activity in breast cancer survivors, the volitional help sheet may be more effective for facilitating lasting change and emotional well-being. Findings suggest that the volitional help sheet may have potential to offer a cost-effective contribution to consumer-led tertiary preventive health. Future research should test these initial findings in a definitive trial. Statement of contribution What is already known on this subject? Physical activity is important for optimizing health in breast cancer survivors. Despite this, physical activity in this cohort remains low. Theory-based strategies are needed to help breast cancer survivors independently manage and maintain regular physical activity over the long term. What does this study add? Online planning interventions can improve physical activity in breast cancer survivors. Volitional help sheets, but not implementation intentions, show sustained

  7. Trial-to-trial Adaptation: Parsing out the Roles of Cerebellum and BG in Predictive Motor Timing.

    PubMed

    Lungu, Ovidiu V; Bares, Martin; Liu, Tao; Gomez, Christopher M; Cechova, Ivica; Ashe, James

    2016-07-01

    We previously demonstrated that predictive motor timing (i.e., timing requiring visuomotor coordination in anticipation of a future event, such as catching or batting a ball) is impaired in patients with spinocerebellar ataxia (SCA) types 6 and 8 relative to healthy controls. Specifically, SCA patients had difficulties postponing their motor response while estimating the target kinematics. This behavioral difference relied on the activation of both cerebellum and striatum in healthy controls, but not in cerebellar patients, despite both groups activating certain parts of cerebellum during the task. However, the role of these two key structures in the dynamic adaptation of the motor timing to target kinematic properties remained unexplored. In the current paper, we analyzed these data with the aim of characterizing the trial-by-trial changes in brain activation. We found that in healthy controls alone, and in comparison with SCA patients, the activation in bilateral striatum was exclusively associated with past successes and that in the left putamen, with maintaining a successful performance across successive trials. In healthy controls, relative to SCA patients, a larger network was involved in maintaining a successful trial-by-trial strategy; this included cerebellum and fronto-parieto-temporo-occipital regions that are typically part of attentional network and action monitoring. Cerebellum was also part of a network of regions activated when healthy participants postponed their motor response from one trial to the next; SCA patients showed reduced activation relative to healthy controls in both cerebellum and striatum in the same contrast. These findings support the idea that cerebellum and striatum play complementary roles in the trial-by-trial adaptation in predictive motor timing. In addition to expanding our knowledge of brain structures involved in time processing, our results have implications for the understanding of BG disorders, such as Parkinson disease

  8. Comparison of behavioural activation with guided self-help for treatment of depression in adults with intellectual disabilities: a randomised controlled trial.

    PubMed

    Jahoda, Andrew; Hastings, Richard; Hatton, Chris; Cooper, Sally-Ann; Dagnan, Dave; Zhang, Ruiqi; McConnachie, Alex; McMeekin, Nicola; Appleton, Kim; Jones, Rob; Scott, Katie; Fulton, Lauren; Knight, Rosie; Knowles, Dawn; Williams, Chris; Briggs, Andrew; MacMahon, Ken; Lynn, Helen; Smith, Ian; Thomas, Gail; Melville, Craig

    2017-12-01

    Psychological therapies are first-line interventions for depression, but existing provision is not accessible for many adults with intellectual disabilities. We investigated the clinical and cost-effectiveness of a behavioural activation intervention (BeatIt) for people with intellectual disabilities and depression. BeatIt was compared with a guided self-help intervention (StepUp). We did a multicentre, single-blind, randomised, controlled trial with follow-up at 4 months and 12 months after randomisation. Participants aged 18 years or older, with mild to moderate intellectual disabilities and clinically significant depression were recruited from health and social care services in the UK. The primary outcome was the Glasgow Depression Scale for people with a Learning Disability (GDS-LD) score at 12 months. Analyses were done on an intention-to-treat basis. This trial is registered with ISCRTN, number ISRCTN09753005. Between Aug 8, 2013, and Sept 1, 2015, 161 participants were randomly assigned (84 to BeatIt; 77 to StepUp); 141 (88%) participants completed the trial. No group differences were found in the effects of BeatIt and StepUp based on GDS-LD scores at 12 months (12·03 [SD 7·99] GDS-LD points for BeatIt vs 12·43 [SD 7·64] GDS-LD points for StepUp; mean difference 0·26 GDS-LD points [95% CI -2·18 to 2·70]; p=0·833). Within-group improvements in GDS-LD scores occurred in both groups at 12 months (BeatIt, mean change -4·2 GDS-LD points [95% CI -6·0 to -2·4], p<0·0001; StepUp, mean change -4·5 GDS-LD points [-6·2 to -2·7], p<0·0001), with large effect sizes (BeatIt, 0·590 [95% CI 0·337-0·844]; StepUp, 0·627 [0·380-0·873]). BeatIt was not cost-effective when compared with StepUp, although the economic analyses indicated substantial uncertainty. Treatment costs were only approximately 3·6-6·8% of participants' total support costs. No treatment-related or trial-related adverse events were reported. This study is, to our knowledge, the first

  9. WITHDRAWN: Advice to stay active as a single treatment for low-back pain and sciatica.

    PubMed

    Hilde, G; Hagen, K B; Jamtvedt, G; Winnem, M

    2007-07-18

    Low back pain is one of the most common conditions managed in primary care. Restricted activity, rest, and symptomatic analgesics are the most commonly prescribed treatment for low back pain and sciatica. To assess the effects of advice to stay active as single treatment for patients with low back pain. Computerised searches in MEDLINE, EMBASE, Sport, The Cochrane Controlled Trials Register, Musculoskeletal Group's Trials Register and Scisearch, and scanning of reference lists from relevant articles were undertaken. Relevant studies were also traced by contacting authors. Date of the most recent searches: December 1998. We included all randomised trials or quasi-randomised trials where the study population consisted of adult patients with low back pain or sciatica, in which one comparison group was advised to stay active. The main outcomes of interest were pain, functional status, recovery and return to work. Two reviewers independently selected trials for inclusion, assessed the validity of included trials and extracted data. Investigators were contacted to collect missing data or for clarification when needed. Four trials, with a total of 491 patients, were included. Advice to stay active was compared to advice to rest in bed in all trials. Two trials were assessed to have low risk of bias and two to have moderate to high risk of bias. The results were heterogeneous. Results from one high quality trial of patients with acute simple LBP found small differences in functional status [Weighted Mean Difference (on a 0-100 scale) 6.0 (95% CI: 1.5, 10.5)] and length of sick leave [WMD 3.4 days (95% CI: 1.6, 5.2)] in favour of staying active compared to advice to stay in bed for two days. The other high quality trial compared advice to stay active with advice to rest in bed for 14 days for patients with sciatic syndrome, and found no differences between the groups. One of the high quality trials also compared advice to stay active with exercises for patients with acute

  10. Investigating methotrexate toxicity within a randomized double-blinded, placebo-controlled trial: rationale and design of the Cardiovascular Inflammation Reduction Trial-Adverse Events (CIRT-AE) Study

    USDA-ARS?s Scientific Manuscript database

    Background: The role of low dose methotrexate (LDM) in potential serious toxicities remains unclear despite its common use. Prior observational studies investigating LDM toxicity compared LDM to other active drugs. Prior placebo-controlled clinical trials of LDM in inflammatory conditions were not l...

  11. Prospective controlled trial comparing colostomy irrigation with "spontaneous-action" method.

    PubMed

    Williams, N S; Johnston, D

    1980-07-12

    Thirty randomly selected patients with permanent colostomies entered a prospective controlled trial comparing colostomy irrigation with spontaneous action. Each patient was interviewed and examined before irrigation was begun and again after the technique had been used for three months. Each then reverted to spontaneous action for a further three months and was then reassessed. Eight patients abandoned irrigation and 22 (73%) adhered to the protocol. Irrigation caused no mishaps or complications. The mean time spent managing the stoma was 45 +/- SEM 9 min/24 hours during spontaneous action and 53 +/- 9 min/24 hours during irrigation. This difference was not significant. The numbers of bowel actions weekly were 13 +/ SEM 2 during spontaneous action and 6 +/- 1 during irrigation (p < 0.01). Irrigation reduced odour and flatus in 20 patients and enabled 12 out of 18 to stop using drugs and seven to discard their appliance. Irrigation also improved the social life of 18 patients and the working conditions of eight out of 14. These finding show that some patients may not be suitable for irrigation but that for many it is better than the conventional British method of colostomy management. With modern apparatus the technique is safe.

  12. Coping with Trial-to-Trial Variability of Event Related Signals: A Bayesian Inference Approach

    NASA Technical Reports Server (NTRS)

    Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.

    2005-01-01

    In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.

  13. EAP viewpoint on unpublished data from paediatric clinical trials.

    PubMed

    Schrier, L; Illy, K; Valiulis, A; Wyder, C; Stiris, T

    2018-02-01

    European children and paediatricians rely heavily on the fair, complete and timely publication of data obtained from paediatric randomised controlled trials (RCTs). Selective publication and reporting of paediatric RCTs is common practice. Industry-sponsored trials are more likely to remain unpublished, and take longer to get published compared with trials sponsored by others. However, also academic sponsors contribute to inefficiencies in publishing clinical data. Publication bias violates the ethical obligation that investigators have towards study participants, leads to considerable inefficiencies in research and a waste of financial and human resources, and has the potential to distort evidence for treatment approaches. The European Academy of Paediatrics (EAP) therefore actively supports initiatives that increase the public dissemination of paediatric clinical trial data. The EAP will raise awareness about the guidelines for Good Publication Practice among European paediatricians and subspecialty societies.

  14. Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial

    PubMed Central

    2012-01-01

    Background Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice. Methods A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14. Results 278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups. Conclusion Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care. Trial registration ISRCTN62203233. PMID:22361121

  15. Sydney Playground Project: A Cluster-Randomized Trial to Increase Physical Activity, Play, and Social Skills

    ERIC Educational Resources Information Center

    Bundy, Anita; Engelen, Lina; Wyver, Shirley; Tranter, Paul; Ragen, Jo; Bauman, Adrian; Baur, Louise; Schiller, Wendy; Simpson, Judy M.; Niehues, Anita N.; Perry, Gabrielle; Jessup, Glenda; Naughton, Geraldine

    2017-01-01

    Background: We assessed the effectiveness of a simple intervention for increasing children's physical activity, play, perceived competence/social acceptance, and social skills. Methods: A cluster-randomized controlled trial was conducted, in which schools were the clusters. Twelve Sydney (Australia) primary schools were randomly allocated to…

  16. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials.

    PubMed

    Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa

    2014-04-29

    Researchers and organizations often use evidence from randomized controlled trials (RCTs) to determine the efficacy of a treatment or intervention under ideal conditions. Studies of observational designs are often used to measure the effectiveness of an intervention in 'real world' scenarios. Numerous study designs and modifications of existing designs, including both randomized and observational, are used for comparative effectiveness research in an attempt to give an unbiased estimate of whether one treatment is more effective or safer than another for a particular population.A systematic analysis of study design features, risk of bias, parameter interpretation, and effect size for all types of randomized and non-experimental observational studies is needed to identify specific differences in design types and potential biases. This review summarizes the results of methodological reviews that compare the outcomes of observational studies with randomized trials addressing the same question, as well as methodological reviews that compare the outcomes of different types of observational studies. To assess the impact of study design (including RCTs versus observational study designs) on the effect measures estimated.To explore methodological variables that might explain any differences identified.To identify gaps in the existing research comparing study designs. We searched seven electronic databases, from January 1990 to December 2013.Along with MeSH terms and relevant keywords, we used the sensitivity-specificity balanced version of a validated strategy to identify reviews in PubMed, augmented with one term ("review" in article titles) so that it better targeted narrative reviews. No language restrictions were applied. We examined systematic reviews that were designed as methodological reviews to compare quantitative effect size estimates measuring efficacy or effectiveness of interventions tested in trials with those tested in observational studies

  17. Delta Healthy Sprouts: a randomized comparative effectiveness trial to promote maternal weight control and reduce childhood obesity in the Mississippi Delta.

    PubMed

    Thomson, Jessica L; Tussing-Humphreys, Lisa M; Goodman, Melissa H

    2014-05-01

    Excessive and inadequate gestational weight gain can complicate a woman's pregnancy and put her and her child at risk for poor delivery and birth outcomes. Further, feeding and activity habits established early in life can significantly impact the development of childhood obesity. The on-going Delta Healthy Sprouts Project is a randomized, controlled, comparative trial testing the efficacy of two Maternal, Infant, and Early Childhood Home Visiting programs on weight status and health behaviors of 150 mothers and their infants residing in the rural Mississippi Delta region of the United States. Women are enrolled in their second trimester of pregnancy and randomized to one of two treatment arms. The control arm curriculum is based on Parents as Teachers, an evidence based approach to increase parental knowledge of child development and improve parenting practices. The experimental arm, labeled Parents as Teachers Enhanced, builds upon the control curriculum by including culturally tailored nutrition and physical activity components specifically designed for the gestational and postnatal periods. We hypothesize that, as compared to the control arm, the experimental arm will be more effective in preventing inappropriate gestational weight gain, reducing postnatal weight retention, and decreasing infant obesity rates. We also will evaluate mother and child dietary and physical activity outcomes, breastfeeding initiation and continuation, and child feeding practices. The Delta Healthy Sprouts Project tests a novel, combined approach to maternal weight management and childhood obesity prevention in pregnant women and their children at high risk for obesity and chronic disease. Published by Elsevier Inc.

  18. Liver Afferents Contribute to Water Drinking-Induced Sympathetic Activation in Human Subjects: A Clinical Trial

    PubMed Central

    May, Marcus; Gueler, Faikah; Barg-Hock, Hannelore; Heiringhoff, Karl-Heinz; Engeli, Stefan; Heusser, Karsten; Diedrich, André; Brandt, André; Strassburg, Christian P.; Tank, Jens; Sweep, Fred C. G. J.; Jordan, Jens

    2011-01-01

    Water drinking acutely increases sympathetic activity in human subjects. In animals, the response appears to be mediated through transient receptor potential channel TRPV4 activation on osmosensitive hepatic spinal afferents, described as osmopressor response. We hypothesized that hepatic denervation attenuates water drinking-induced sympathetic activation. We studied 20 liver transplant recipients (44±2.6 years, 1.2±0.1 years post transplant) as model of hepatic denervation and 20 kidney transplant recipients (43±2.6 years, 0.8±0.1 years post transplant) as immunosuppressive drug matched control group. Before and after 500 ml water ingestion, we obtained venous blood samples for catecholamine analysis. We also monitored brachial and finger blood pressure, ECG, and thoracic bioimpedance. Plasma norepinephrine concentration had changed by 0.01±0.07 nmol/l in liver and by 0.21±0.07 nmol/l in kidney transplant recipients (p<0.05 between groups) after 30–40 minutes of water drinking. While blood pressure and systemic vascular resistance increased in both groups, the responses tended to be attenuated in liver transplant recipients. Our findings support the idea that osmosensitive hepatic afferents are involved in water drinking-induced sympathetic activation in human subjects. Trial Registration ClinicalTrials.gov NCT01237431 PMID:22016786

  19. TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

    PubMed

    McClinton, Samuel; Cameron, Sarah; Starr, Kathryn; Thomas, Ruth; MacLennan, Graeme; McDonald, Alison; Lam, Thomas; N'Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Keeley, Frank; Burgess, Neil; Clark, Charles Terry; MacLennan, Sara; Norrie, John

    2018-05-22

    Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention. The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden). The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option. The TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones. Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from

  20. Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial.

    PubMed

    McBane Ii, Robert; Loprinzi, Charles L; Ashrani, Aneel; Perez-Botero, Juliana; Leon Ferre, Roberto A; Henkin, Stanislav; Lenz, Charles J; Le-Rademacher, Jennifer G; Wysokinski, Waldemar E

    2017-10-05

    Currently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.

  1. Controlled trial of anti-tuberculous chemotherapy for two years in Crohn's disease.

    PubMed Central

    Swift, G L; Srivastava, E D; Stone, R; Pullan, R D; Newcombe, R G; Rhodes, J; Wilkinson, S; Rhodes, P; Roberts, G; Lawrie, B W

    1994-01-01

    One hundred and thirty patients with active symptoms of Crohn's disease were treated in a double blind randomised controlled trial with rifampicin, isoniazid, and ethambutol, or identical placebos for up to two years. All other treatment considered necessary was continued. Analyses were based on 126 patients, 63 in each treatment group. Thirty seven in the active and 30 in the placebo group had previous surgical procedures. There was no difference in concomitant treatment between the two groups. Thirty in the active and 46 in the placebo groups were taking corticosteroids at entry to the trial. Forty eight of 63 patients in the active and 49 of 63 in the placebo group, completed at least 12 months' therapy. Reasons for early withdrawal included pregnancy, adverse reaction, and failure to comply. There was no significant difference in the mean number of months completed between the two groups. Nineteen adverse reactions were recorded for 17 patients in the active group compared with three reactions in patients on placebo. All of the nine patients withdrawn early because of adverse reactions were in the active group. Fifteen patients on active treatment and 14 on placebo had surgery during the trial with no difference in the type of surgery required between the groups. Radiological assessments based on 98 patients at the end of the trial showed no significant differences between groups in changes of extent of disease. More patients developed strictures on placebo compared with active treatment but without a statistically significant difference. No differences were found between groups for the total prednisolone dose or the number of days on which prednisolone dose was 10 mg or above. Serial measurements of body weight and Crohn's disease activity index (CDAI) together with blood values for albumin, haemoglobin, white cell count, and platelets showed no consistent different differences between groups. There were occasional significant differences for some of these

  2. Knee joint distraction compared with high tibial osteotomy: a randomized controlled trial.

    PubMed

    van der Woude, J A D; Wiegant, K; van Heerwaarden, R J; Spruijt, S; van Roermund, P M; Custers, R J H; Mastbergen, S C; Lafeber, F P J G

    2017-03-01

    Both, knee joint distraction as a relatively new approach and valgus-producing opening-wedge high tibial osteotomy (HTO), are knee-preserving treatments for knee osteoarthritis (OA). The efficacy of knee joint distraction compared to HTO has not been reported. Sixty-nine patients with medial knee joint OA with a varus axis deviation of <10° were randomized to either knee joint distraction (n = 23) or HTO (n = 46). Questionnaires were assessed at baseline and 3, 6, and 12 months. Joint space width (JSW) as a surrogate measure for cartilage thickness was determined on standardized semi-flexed radiographs at baseline and 1-year follow-up. All patient-reported outcome measures (PROMS) improved significantly over 1 year (at 1 year p < 0.02) in both groups. At 1 year, the HTO group showed slightly greater improvement in 4 of the 16 PROMS (p < 0.05). The minimum medial compartment JSW increased 0.8 ± 1.0 mm in the knee joint distraction group (p = 0.001) and 0.4 ± 0.5 mm in the HTO group (p < 0.001), with minimum JSW improvement in favour of knee joint distraction (p = 0.05). The lateral compartment showed a small increase in the knee joint distraction group and a small decrease in the HTO group, leading to a significant increase in mean JSW for knee joint distraction only (p < 0.02). Cartilaginous repair activity, as indicated by JSW, and clinical outcome improvement occurred with both, knee joint distraction and HTO. These findings suggest that knee joint distraction may be an alternative therapy for medial compartmental OA with a limited mechanical leg malalignment. Randomized controlled trial, Level I.

  3. Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults.

    PubMed

    Brach, Jennifer S; Perera, Subashan; Gilmore, Sandra; VanSwearingen, Jessie M; Brodine, Deborah; Wert, David; Nadkarni, Neelesh K; Ricci, Edmund

    2016-09-01

    Group exercise programs for older adults often exclude the timing and coordination of movement. Stakeholder involvement in the research process is strongly encouraged and improves the relevance and adoption of findings. We describe stakeholder involvement in the design of a clinical trial of a group-based exercise program that incorporates timing and coordination of movement into the exercises. The study was a cluster randomized, single-blind intervention trial to compare the effects on function, disability and mobility of a standard group exercise program and the "On the Move" group exercise program in older adults residing in independent living facilities and senior apartment buildings, and attending community centers. Exercise classes were twice weekly for 12weeks delivered by study exercise leaders and facility activity staff personnel. The primary outcomes function, disability and mobility were assessed at baseline and post-intervention. Function and disability were assessed using the Late Life Function and Disability Instrument, and mobility using the Six-Minute Walk Test and gait speed. Patient and provider stakeholders had significant input into the study aims, design, sample, intervention, outcomes and operational considerations. A community-based exercise program to improve walking can be developed to address both investigator identified missing components in current exercise to improve walking and stakeholder defined needs and interest for the activity program. Involvement of stakeholders substantially improves the relevance of research questions, increases the transparency of research activities and may accelerate the adoption of research into practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. AnAnkle Trial study protocol: a randomised trial comparing pain profiles after peripheral nerve block or spinal anaesthesia for ankle fracture surgery.

    PubMed

    Sort, Rune; Brorson, Stig; Gögenur, Ismail; Møller, Ann Merete

    2017-06-02

    Ankle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery. AnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment. The intervention is ultrasound-guided popliteal sciatic (20 mL) and saphenal nerve (8 mL) PNB with ropivacaine 7.5 mg/mL, and controls receive spinal anaesthesia (2 mL) with hyperbaric bupivacaine 5 mg/mL. Postoperatively all receive paracetamol, ibuprofen and patient-controlled intravenous morphine on demand. Morphine consumption and pain scores are registered in the first 27 hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation of anaesthesia, opioid side effects (Opioid-Related Symptom Distress Scale), quality of recovery (Danish Quality of Recovery-15 score) and pain scores and medication days 1-7 (diary). The study has been approved by the Regional Ethics Committees in the Capital Region of Denmark, the Danish Data Protection Agency and the Danish Health and Medical Authority. We will publish the results in international peer-reviewed medical journals. AnAnkle Trial is registered in the European Clinical Trials Database (EudraCT 2015

  5. 1,2-Octanediol, a Novel Surfactant, for Treating Head Louse Infestation: Identification of Activity, Formulation, and Randomised, Controlled Trials

    PubMed Central

    Burgess, Ian F.; Lee, Peter N.; Kay, Katrina; Jones, Ruth; Brunton, Elizabeth R.

    2012-01-01

    Background Interest in developing physically active pediculicides has identified new active substances. The objective was to evaluate a new treatment for clinical efficacy. Methods and Findings We describe the selection of 1,2-octanediol as a potential pediculicide. Clinical studies were community based. The main outcome measure was no live lice, after two treatments, with follow up visits over 14 days. Study 1 was a proof of concept with 18/20 (90%) participants cured. Study 2 was a multicentre, parallel, randomised, observer-blind study (520 participants) that compared 0.5% malathion liquid with 1,2-octanediol lotion (20% alcohol) applied 2–2.5 hours or 8 hours/overnight. 1,2-octanediol lotion was significantly (p<0.0005) more effective with success for 124/175 (70.9%) RR = 1.50 (97.5% CI, 1.22 to 1.85) for 2–2.5 hours, and 153/174 (87.9%) RR = 1.86 (97.5% CI, 1.54 to 2.26) for 8 hours/overnight compared with 81/171 (47.4%) for malathion. Study 3, a two centre, parallel, randomised, observer-blind study (121 participants), compared 1,2-octanediol lotion, 2–2.5 hours with 1,2-octanediol alcohol free mousse applied for 2–2.5 hours or 8 hours/overnight. The mousse applied for 8 hours/overnight cured 31/40 (77.5%), compared with 24/40 (60.0%) for lotion (RR = 1.29, 95% CI, 0.95 to 1.75; NNT = 5.7) but mousse applied for 2–2.5 hours 17/41 (41.5%) was less effective than lotion (RR = 0.69, 95% CI, 0.44 to 1.08). Adverse events were more common using 1,2-octanediol lotion at both 2–2.5 hours (12.0%, p = 0.001) and 8 hours/overnight (14.9%, p<0.0005), compared with 0.5% malathion (2.3%). Similar reactions were more frequent (p<0.045) using lotion compared with mousse. Conclusions 1,2-octanediol was found to eliminate head louse infestation. It is believed to disrupt the insect's cuticular lipid, resulting in dehydration. The alcohol free mousse is more acceptable exhibiting significantly fewer adverse reactions. Trial registrations

  6. The next generation of sepsis trials: What’s next after the demise of recombinant human activated Protein C?

    PubMed Central

    Opal, Steven M.; Dellinger, R. Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C.

    2014-01-01

    Progress in the development of novel therapeutics to treat sepsis has come to virtual standstill. While enormous strides have been made in the understanding of basic molecular mechanisms that underlie the pathophysiology of sepsis, a distressingly long list of novel therapeutic agents have been tested in large clinical trials over the past 25 years without a single, specific, immunomodulating agent showing consistent benefit in sepsis trials. The only novel anti-sepsis agent to successfully complete a phase 3 sepsis trial, human recombinant activated protein C, was recently taken off the market after a follow up placebo-controlled trial (PROWESS SHOCK) failed to replicate the results of the initial registration trial (PROWESS) performed 10 yr earlier. We must critically re-examine our basic approach in the preclinical and clinical evaluation of new sepsis therapies. We propose 12 specific recommendations that if implemented could improve the outlook for developing new drugs for sepsis. PMID:24717456

  7. Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

    PubMed

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale.

  8. Stent thrombosis: insights on outcomes, predictors and impact of dual antiplatelet therapy interruption from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials.

    PubMed

    Kedhi, Elvin; Stone, Gregg W; Kereiakes, Dean J; Serruys, Patrick W; Parise, Helen; Fahy, Martin; Simonton, Charles A; Sudhir, Krishnankutty; Sood, Poornima; Smits, Pieter C

    2012-09-01

    Recent studies have suggested that EES may reduce ST compared to PES, but no individual trial has been adequately powered for this endpoint. The incidence of stent thrombosis, as well as the impact of dual antiplatelet therapy (DAPT) discontinuation during the first two years following everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) deployment were therefore analysed from a pooled, patient-level database derived from four randomised clinical trials. Data from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE trials (n=6,789 patients) were analysed. Two-year ST rates were determined using time-to-event methods and compared with the log-rank test. ST rates were also determined after DAPT discontinuation. EES compared to PES significantly reduced the two-year rates of ST (0.7% versus 2.3%, p=0.0001), including the interval rates of ST up to 30 days (0.2% versus 1.0%, p<0.0001), between 31 days and one year (0.2% versus 0.6%, p=0.02), and after one year (0.3% versus 0.8%, p=0.001). EES also reduced the two-year composite rate of cardiac death or MI (4.0% versus 6.6%, p=0.0001). Increased rates of ST after DAPT discontinuation beyond six months were observed in the PES cohort, but not in the EES cohort. In this large pooled analysis from four randomised trials, treatment with EES compared to PES significantly reduced the rates of ST through two years of follow-up, with a concomitant reduction in cardiac death or MI. DAPT discontinuation beyond six months may be safe with EES.

  9. Funding oncology clinical trials: are cooperative group trials sustainable?

    PubMed

    Seow, Hsien-Yeang; Whelan, Patrick; Levine, Mark N; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca Y; Arnold, Andrew

    2012-05-01

    Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.

  10. Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

    PubMed

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

    2018-02-26

    To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

  11. Effects of a standard provision versus an autonomy supportive exercise referral programme on physical activity, quality of life and well-being indicators: a cluster randomised controlled trial.

    PubMed

    Duda, Joan L; Williams, Geoffrey C; Ntoumanis, Nikos; Daley, Amanda; Eves, Frank F; Mutrie, Nanette; Rouse, Peter C; Lodhia, Rekha; Blamey, Ruth V; Jolly, Kate

    2014-01-29

    The National Institute for Health and Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials. Recent empirical evidence in health care and physical activity promotion contexts provides a foundation for testing the feasibility and impact of a Self Determination Theory-based (SDT) exercise referral consultation. An exploratory cluster randomised controlled trial comparing standard provision exercise referral with an exercise referral intervention grounded in Self Determination Theory. Individuals (N = 347) referred to an exercise referral scheme were recruited into the trial from 13 centres.Outcomes and processes of change measured at baseline, 3 and 6-months: Minutes of self-reported moderate or vigorous physical activity (PA) per week (primary outcome), health status, positive and negative indicators of emotional well-being, anxiety, depression, quality of life (QOL), vitality, and perceptions of autonomy support from the advisor, need satisfaction (3 and 6 months only), intentions to be active, and motivational regulations for exercise.Blood pressure and weight were assessed at baseline and 6 months. Perceptions of the autonomy support provided by the health and fitness advisor (HFA) did not differ by arm. Between group changes over the 6-months revealed significant differences for reported anxiety only. Within arm contrasts revealed significant improvements in anxiety and most of the Dartmouth CO-OP domains in the SDT arm at 6 months, which were not seen in the standard exercise referral group. A process model depicting hypothesized relationships between advisor autonomy support, need satisfaction and more autonomous motivation, enhanced well being and PA engagement at follow up was supported. Significant gains in physical activity and improvements in quality of life and well-being outcomes emerged in both the standard provision exercise

  12. The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study.

    PubMed

    Shingler, Ellie; Hackshaw-McGeagh, Lucy; Robles, Luke; Persad, Raj; Koupparis, Anthony; Rowe, Edward; Shiridzinomwa, Constance; Bahl, Amit; Martin, Richard M; Lane, J Athene

    2017-03-07

    There is increasing evidence that low levels of physical activity and diets low in fruit and vegetables and high in meat and dairy products are risk factors for prostate cancer disease progression. The Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) aimed to assess a diet and physical activity intervention in men undergoing radical prostatectomy for localized prostate cancer. The trial included a qualitative component to explore the experiences of men participating in the trial in order to understand the acceptability of the intervention and data collection methods. We report the qualitative findings of the trial and consider how these can be used to inform future research. PrEvENT involved randomizing men to either a dietary and/or physical activity intervention. Semi-structured interviews were conducted with a purposive sample of 17 men on completion of the 6 month trial. Interviews took place in clinic or as telephone interviews, if requested by the participant, and were audio recorded, transcribed, and analyzed using the thematic-based framework approach. Analysis was conducted throughout the data collection process to allow emergent themes to be further explored in subsequent interviews. Three overarching themes were identified: acceptability of the intervention, acceptability of the data collection methods and trial logistics. Participants were predominantly positive about both the dietary and physical activity interventions and most men found the methods of data collection appropriate. Recommendations for future trials include consideration of alternative physical activity options, such as cycling or gym sessions, increased information on portion sizes, the potential importance of including wives or partners in the dietary change process and the possibility of using the pedometer or other wearable technology as part of the physical activity intervention. We provide insight into the opinions and experiences of the acceptability of the Pr

  13. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

    PubMed

    Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

    2013-01-01

    To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p < .01). Compared with multi-port surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  14. Comparative efficacy of low-dose versus standard-dose azithromycin for patients with yaws: a randomised non-inferiority trial in Ghana and Papua New Guinea.

    PubMed

    Marks, Michael; Mitjà, Oriol; Bottomley, Christian; Kwakye, Cynthia; Houinei, Wendy; Bauri, Mathias; Adwere, Paul; Abdulai, Abdul A; Dua, Fredrick; Boateng, Laud; Wangi, James; Ohene, Sally-Ann; Wangnapi, Regina; Simpson, Shirley V; Miag, Helen; Addo, Kennedy K; Basing, Laud A; Danavall, Damien; Chi, Kai H; Pillay, Allan; Ballard, Ronald; Solomon, Anthony W; Chen, Cheng Y; Bieb, Sibauk V; Adu-Sarkodie, Yaw; Mabey, David C W; Asiedu, Kingsley

    2018-04-01

    A dose of 30 mg/kg of azithromycin is recommended for treatment of yaws, a disease targeted for global eradication. Treatment with 20 mg/kg of azithromycin is recommended for the elimination of trachoma as a public health problem. In some settings, these diseases are co-endemic. We aimed to determine the efficacy of 20 mg/kg of azithromycin compared with 30 mg/kg azithromycin for the treatment of active and latent yaws. We did a non-inferiority, open-label, randomised controlled trial in children aged 6-15 years who were recruited from schools in Ghana and schools and the community in Papua New Guinea. Participants were enrolled based on the presence of a clinical lesion that was consistent with infectious primary or secondary yaws and a positive rapid diagnostic test for treponemal and non-treponemal antibodies. Participants were randomly assigned (1:1) to receive either standard-dose (30 mg/kg) or low-dose (20 mg/kg) azithromycin by a computer-generated random number sequence. Health-care workers assessing clinical outcomes in the field were not blinded to the patient's treatment, but investigators involved in statistical or laboratory analyses and the participants were blinded to treatment group. We followed up participants at 4 weeks and 6 months. The primary outcome was cure at 6 months, defined as lesion healing at 4 weeks in patients with active yaws and at least a four-fold decrease in rapid plasma reagin titre from baseline to 6 months in patients with active and latent yaws. Active yaws was defined as a skin lesion that was positive for Treponema pallidum ssp pertenue in PCR testing. We used a non-inferiority margin of 10%. This trial was registered with ClinicalTrials.gov, number NCT02344628. Between June 12, 2015, and July 2, 2016, 583 (65·1%) of 895 children screened were enrolled; 292 patients were assigned a low dose of azithromycin and 291 patients were assigned a standard dose of azithromycin. 191 participants had active yaws and 392 had presumed

  15. Efficacy and safety of apixaban compared with aspirin in the elderly: a subgroup analysis from the AVERROES trial.

    PubMed

    Ng, Kuan H; Shestakovska, Olga; Connolly, Stuart J; Eikelboom, John W; Avezum, Alvaro; Diaz, Rafael; Lanas, Fernando; Yusuf, Salim; Hart, Robert G

    2016-01-01

    increasing age is associated with a higher prevalence of atrial fibrillation (AF), and higher risks of stroke and bleeding. We report the effects of apixaban versus acetylsalicylic acid (ASA) in older patients (≥75 years and ≥85 years) compared with younger patients with AF unsuitable for vitamin K antagonists. AVERROES (Apixaban Versus ASA to Prevent Stroke In AF Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment) trial (n = 5,599) included 1,898 patients ≥75 years and 366 patients ≥85 years. We compared the baseline characteristics and effects of apixaban compared with aspirin on clinical outcomes by age. compared with aspirin, apixaban was more efficacious for preventing strokes and systemic embolism in patients ≥85 years (absolute rate [AR] 1%/year on apixaban versus 7.5%/year on aspirin; hazard ratio [HR] 0.14, 95% confidence interval [CI] 0.02-0.48) compared with younger patients (AR 1.7%/year on apixaban versus 3.4%/year on aspirin; HR 0.50, 95% CI 0.35-0.69) (P-value for interaction = 0.05). Major haemorrhage was higher in patients ≥85 years compared with younger patients but similar with apixaban versus aspirin in both young and older individuals (4.9%/year versus 1.0%/year on aspirin and 4.7%/year versus 1.2%/year on apixaban) with no significant treatment-by-age interaction (P-value = 0.65). older patients with AF are at particularly high risk of stroke if given aspirin and have substantially greater relative and absolute benefits from apixaban compared with younger patients with no greater risk of haemorrhage. ClinicalTrials.gov number: NCT00496769. URL: https://clinicaltrials.gov/ct2/show/NCT00496769. © The Author 2015. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

    PubMed Central

    Ragni, Margaret V

    2011-01-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

  17. Commercial programs' online weight loss claims as compared to results from randomized controlled trials

    PubMed Central

    Vakil, Rachit M.; Chaudhry, Zoobia W.; Doshi, Ruchi S.; Clark, Jeanne M.; Gudzune, Kimberly A.

    2017-01-01

    Objective To characterize weight-loss claims and disclaimers present on websites for commercial weight-loss programs and compare them to results from published randomized controlled trials (RCT). Methods We performed a content analysis of all homepages and testimonials available on the websites of 24 randomly selected programs. Two team members independently reviewed each page and abstracted information from text and images to capture relevant content including demographics, weight loss, and disclaimers. We performed a systematic review to evaluate the efficacy of these programs by searching MEDLINE and Cochrane Database of Systematic Reviews, and abstracted mean weight change from each included RCT. Results Overall, the amount of weight loss portrayed in the testimonials was extreme across all programs examined (range median weight loss 10.7 to 49.5 kg). Only 10 out of the 24 programs had eligible RCTs. Median weight losses reported in testimonials exceeded that achieved by trial participants. Most programs with RCTs (78%) provided disclaimers stating that the testimonial's results were non-typical and/or giving a range of typical weight loss. Conclusion Weight loss claims within testimonials were higher than results from RCTs. Future studies should examine whether commercial programs' advertising practices influence patients' expectations or satisfaction with modest weight loss results. PMID:28865085

  18. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    PubMed

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (p<0.001), multicenter trials (p<0.001) and publication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  19. The Effect of the More Active MuMs in Stirling Trial on Body Composition and Psychological Well-Being among Postnatal Women.

    PubMed

    Lee, Alyssa S; McInnes, Rhona J; Hughes, Adrienne R; Guthrie, Wendy; Jepson, Ruth

    2016-01-01

    Introduction. Physical activity is important for health and well-being; however, rates of postnatal physical activity can be low. This paper reports the secondary outcomes of a trial aimed at increasing physical activity among postnatal women. Methods. More Active MuMs in Stirling (MAMMiS) was a randomised controlled trial testing the effect of physical activity consultation and pram walking group intervention among inactive postnatal women. Data were collected on postnatal weight, body composition, general well-being, and fatigue. Participants were also interviewed regarding motivations and perceived benefits of participating in the trial. Results. There was no significant effect of the intervention on any weight/body composition outcome or on general well-being at three or six months of follow-up. There was a significant but inconsistent difference in fatigue between groups. Qualitative data highlighted a number of perceived benefits to weight, body composition, and particularly well-being (including improved fatigue) which were not borne out by objective data. Discussion. The MAMMiS study found no impact of the physical activity intervention on body composition and psychological well-being and indicates that further research is required to identify successful approaches to increase physical activity and improve health and well-being among postnatal women.

  20. A Mock Randomized Controlled Trial With Audience Response Technology for Teaching and Learning Epidemiology.

    PubMed

    Baker, Philip R A; Francis, Daniel P; Cathcart, Abby

    2017-04-01

    The study's objective was to apply and assess an active learning approach to epidemiology and critical appraisal. Active learning comprised a mock, randomized controlled trial (RCT) conducted with learners in 3 countries. The mock trial consisted of blindly eating red Smarties candy (intervention) compared to yellow Smarties (control) to determine whether red Smarties increase happiness. Audience response devices were employed with the 3-fold purposes to produce outcome data for analysis of the effects of red Smarties, identify baseline and subsequent changes in participant's knowledge and confidence in understanding of RCTs, and assess the teaching approach. Of those attending, 82% (117 of 143 learners) participated in the trial component. Participating in the mock trial was a positive experience, and the use of the technology aided learning. The trial produced data that learners analyzed in "real time" during the class. The mock RCT is a fun and engaging approach to teaching RCTs and helping students to develop skills in critical appraisal.