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  1. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study.

    PubMed

    King, William D; Defreitas, Donna; Smith, Kimberly; Andersen, Janet; Perry, Lisa Patton; Adeyemi, Toyin; Mitty, Jennifer; Fritsche, Jan; Jeffries, Carrie; Littles, Melvin; Fischl, Margaret; Pavlov, Gregory; Mildvan, Donna

    2007-08-01

    HIV-seropositive blacks, Hispanics, women of all ethnicities, and injection drug users (IDUs) have low rates of clinical trial participation. The opinions of research nurses and study coordinators as potential facilitators and barriers to access to clinical trials may contribute to this disparity. Study coordinators and research nurses from the adult AIDS Clinical Trials Group (ACTG) clinical trials units responded to an anonymous computer-based survey comprising multiple choice questions and clinical scenarios. Descriptive statistics were used to determine frequencies of responses. Recruitment rates of blacks, Hispanics, women and IDUs were mostly rated appropriate compared with the geographic region demographics. Most sites ranked white men as being the most interested in clinical trials. Sites rated their most effective interactions were with white men. Respondents felt they were less likely to enroll individuals who had missed previous clinical appointments or did not speak English. Perceptions that IDUs, Hispanics, blacks, and, to a lesser extent, women had less interest in clinical trials participation than white males may affect recruitment of the targeted populations. Interventions to improve interactions with targeted populations and to remove logistical and language barriers may improve the diversity of clinical trial participants. PMID:17711380

  2. AIDS Clinical Trials Group Network

    MedlinePLUS

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Layman’s Study Summaries Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General ...

  3. Analysis of caries clinical trial data in the presence of study group imbalance.

    PubMed

    Korts, D C

    1977-09-01

    Imbalance of any important factor in caries clinical trials can bias group means, and make decisions based on such means of questionable value. Six hypothetical trials are presented which have varying degrees of imbalance in baseline DMFS. The crude group means for these trials vary radically, from one extreme in which the treated group has significantly less decay than the control group, to the opposite extreme in which the control group has significantly less decay than the treated group. Two methods for adjustment to correct for the imbalances, the analyses of covariance and blocking analysis, are discussed and applied to each trial. For these data sets the blocking analysis appears superior to the analysis of covariance in terms of maintaining the essential character of the data. An appendix explaining in detail how the blocking analysis is performed can be obtained on request to the author. PMID:334455

  4. NCCTG Study N9741: Leveraging Learning from an NCI Cooperative Group Phase III Trial

    PubMed Central

    Goldberg, Richard M.; Sargent, Daniel J.; Morton, Roscoe F.; Green, Erin; Sanoff, Hanna K.; Mcleod, Howard; Buckner, Jan

    2010-01-01

    N9741 is a clinical trial in patients with metastatic colorectal cancer that was originally written in 1997 and completed patient accrual in 2004. One thousand seven hundred thirty-one patients were enrolled in the study. During the conduct of the trial, N9741 was repeatedly modified to adapt to toxicity findings, to add evaluation of oxaliplatin to what was originally a trial examining various schedules of irinotecan-based therapy, and to ask evolving questions. The trial led to a new U.S. Food and Drug Administration indication for 5-fluorouracil, leucovorin, and oxaliplatin as indicated for the treatment of previously untreated patients with metastatic colorectal cancer and helped to change the standard of care for the disease in the U.S. and worldwide. The data from the trial have been used to study multiple regimens, pharmacogenetics, and quality of life issues, to correlate plasma protein levels with outcomes, to inform trial methodology, and to perform economic analyses. To date nearly 30 papers and an even larger number of abstracts have been based upon data arising from the study. The history of the trial and the major findings are summarized in this review. PMID:19828593

  5. Can Research Assessments Themselves Cause Bias in Behaviour Change Trials? A Systematic Review of Evidence from Solomon 4-Group Studies

    PubMed Central

    McCambridge, Jim; Butor-Bhavsar, Kaanan; Witton, John; Elbourne, Diana

    2011-01-01

    Background The possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms: (1) assessed experimental group; (2) unassessed experimental group (3) assessed control group; or (4) unassessed control group. This design provides a test of the internal validity of effect sizes obtained in conventional two-group trials by controlling for the effects of baseline assessment, and assessing interactions between the intervention and baseline assessment. The aim of this systematic review is to evaluate evidence from Solomon 4-group studies with behavioural outcomes that baseline research assessments themselves can introduce bias into trials. Methodology/Principal Findings Electronic databases were searched, supplemented by citation searching. Studies were eligible if they reported appropriately analysed results in peer-reviewed journals and used Solomon 4-group designs in non-laboratory settings with behavioural outcome measures and sample sizes of 20 per group or greater. Ten studies from a range of applied areas were included. There was inconsistent evidence of main effects of assessment, sparse evidence of interactions with behavioural interventions, and a lack of convincing data in relation to the research question for this review. Conclusions/Significance There were too few high quality completed studies to infer conclusively that biases stemming from baseline research assessments do or do not exist. There is, therefore a need for new rigorous Solomon 4-group studies that are purposively designed to evaluate the potential for research assessments to cause bias in behaviour change trials. PMID:22039407

  6. Asperger syndrome and anxiety disorders (PAsSA) treatment trial: a study protocol of a pilot, multicentre, single-blind, randomised crossover trial of group cognitive behavioural therapy

    PubMed Central

    Langdon, Peter E; Murphy, Glynis H; Wilson, Edward; Shepstone, Lee; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra

    2013-01-01

    Introduction A number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious. Methods and analysis This study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money. Ethics and dissemination The trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community. Trial Registration ISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370. PMID:23901031

  7. Determinants of patient recruitment in a multicenter clinical trials group: trends, seasonality and the effect of large studies. | accrualnet.cancer.gov

    Cancer.gov

    The authors developed a model that adequately predicted five-year enrollment trends based on patient enrollment during the first 32 quarters. The study identified key trends and determinants of enrollment in a large multicenter clinical trials group. This information can be used to assess a clinical trials group’s performance over time and plan the strategic development and incorporation of future trials in its program. The predictors and the modeling process may be adapted to other groups and settings.

  8. Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial

    PubMed Central

    Kadimpati, Sandeep; McCormick, Jennifer B; Chiu, Yichen; Parker, Ashley B.; Iftikhar, Aliya Z.; Flick, Randall P.; Warner, David O.

    2014-01-01

    Background In the recent literature, there has been some evidence that exposure of children to anesthetic procedures during the first two years of life may impair cognitive function and learning in later life. We planned a clinical study to quantify this risk, a study involving testing 1,000 children for neurodevelopmental deficits. As a part of this planning, we conducted focus groups involving potential participants and their parents to elicit information regarding three issues: communications with the community and potential participants, recruitment and consent processes, and the return of neurodevelopmental testing results. Methods Three focus groups were conducted with the parents of potential participants and one focus group was conducted with an 18-19 year old group; each group consisted of 6-10 participants. The moderated discussions had questions about recruitment, consenting issues, and expectations from the study about return of both overall trial findings and individual research test results. Results The focus group data gave us an insight on potential participants’ views on recruitment, consenting, communications about the study, and expectations about return of both overall trial findings and individual research test results. The concerns expressed were largely addressable. In addition, the concern we had about some parents enrolling their children in the study solely for the sake of getting their child's cognitive function results was dispelled. Conclusions We found that the individuals participating in our focus groups were generally enthusiastic about the large clinical study and could see the value in answering the study question. The data from the focus groups were used to inform changes to the recruitment and consent process. Focus group input was also instrumental in affirming the study design regarding return of results. Our experience suggests that the approach we used may serve as a model for other investigators to help inform the various elements of clinical study design, in particular the recruitment and consenting processes and expectations of potential participants regarding the return of individual research findings. PMID:24955380

  9. Mediation and spillover effects in group-randomized trials: a case study of the 4Rs educational intervention.

    PubMed

    Vanderweele, Tyler J; Hong, Guanglei; Jones, Stephanie M; Brown, Joshua L

    2013-06-01

    Peer influence and social interactions can give rise to spillover effects in which the exposure of one individual may affect outcomes of other individuals. Even if the intervention under study occurs at the group or cluster level as in group-randomized trials, spillover effects can occur when the mediator of interest is measured at a lower level than the treatment. Evaluators who choose groups rather than individuals as experimental units in a randomized trial often anticipate that the desirable changes in targeted social behaviors will be reinforced through interference among individuals in a group exposed to the same treatment. In an empirical evaluation of the effect of a school-wide intervention on reducing individual students' depressive symptoms, schools in matched pairs were randomly assigned to the 4Rs intervention or the control condition. Class quality was hypothesized as an important mediator assessed at the classroom level. We reason that the quality of one classroom may affect outcomes of children in another classroom because children interact not simply with their classmates but also with those from other classes in the hallways or on the playground. In investigating the role of class quality as a mediator, failure to account for such spillover effects of one classroom on the outcomes of children in other classrooms can potentially result in bias and problems with interpretation. Using a counterfactual conceptualization of direct, indirect and spillover effects, we provide a framework that can accommodate issues of mediation and spillover effects in group randomized trials. We show that the total effect can be decomposed into a natural direct effect, a within-classroom mediated effect and a spillover mediated effect. We give identification conditions for each of the causal effects of interest and provide results on the consequences of ignoring "interference" or "spillover effects" when they are in fact present. Our modeling approach disentangles these effects. The analysis examines whether the 4Rs intervention has an effect on children's depressive symptoms through changing the quality of other classes as well as through changing the quality of a child's own class. PMID:23997375

  10. Trials of large group teaching in Malaysian private universities: a cross sectional study of teaching medicine and other disciplines

    PubMed Central

    2011-01-01

    Background This is a pilot cross sectional study using both quantitative and qualitative approach towards tutors teaching large classes in private universities in the Klang Valley (comprising Kuala Lumpur, its suburbs, adjoining towns in the State of Selangor) and the State of Negeri Sembilan, Malaysia. The general aim of this study is to determine the difficulties faced by tutors when teaching large group of students and to outline appropriate recommendations in overcoming them. Findings Thirty-two academics from six private universities from different faculties such as Medical Sciences, Business, Information Technology, and Engineering disciplines participated in this study. SPSS software was used to analyse the data. The results in general indicate that the conventional instructor-student approach has its shortcoming and requires changes. Interestingly, tutors from Medicine and IT less often faced difficulties and had positive experience in teaching large group of students. Conclusion However several suggestions were proposed to overcome these difficulties ranging from breaking into smaller classes, adopting innovative teaching, use of interactive learning methods incorporating interactive assessment and creative technology which enhanced students learning. Furthermore the study provides insights on the trials of large group teaching which are clearly identified to help tutors realise its impact on teaching. The suggestions to overcome these difficulties and to maximize student learning can serve as a guideline for tutors who face these challenges. PMID:21902839

  11. Defining Responses to Therapy and Study Outcomes in Clinical Trials of Invasive Fungal Diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer Consensus Criteria

    PubMed Central

    Segal, Brahm H.; Herbrecht, Raoul; Stevens, David A.; Ostrosky-Zeichner, Luis; Sobel, Jack; Viscoli, Claudio; Walsh, Thomas J.; Maertens, Johan; Patterson, Thomas F.; Perfect, John R.; Dupont, Bertrand; Wingard, John R.; Calandra, Thierry; Kauffman, Carol A.; Graybill, John R.; Baden, Lindsey R.; Pappas, Peter G.; Bennett, John E.; Kontoyiannis, Dimitrios P.; Cordonnier, Catherine; Viviani, Maria Anna; Bille, Jacques; Almyroudis, Nikolaos G.; Wheat, L. Joseph; Graninger, Wolfgang; Bow, Eric J.; Holland, Steven M.; Kullberg, Bart-Jan; Dismukes, William E.; De Pauw, Ben E.

    2009-01-01

    Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge. PMID:18637757

  12. The Helicobacter pylori eradication in the group receiving standard -dose and group continue taking amoxicillin for 4 weeks; a clinical trial study

    PubMed Central

    Ehsani-Ardakani, Mohammad Javad; Sedaghat, Meghdad; Eslami, Gyti; Mohaghegh Shalmani, Hamid

    2015-01-01

    Aim: The aim of this study was to evaluate the Helicobacter pylori eradication in the group receiving standard -dose twice a day for two weeks and continue taking amoxicillin for 4 weeks. Background: Helicobacter pylori is the major etiological cause of chronic gastritis, gastric and duodenal ulcers, gastric cancer and lymphoma. Therefore, patients should be treated after diagnosis of H. pylori infection. Patients and methods: A total of 66 consecutive patients with rapid urease test during endoscopy or biopsy positive for H. pylori were enrolled in this clinical trial study during 2013-2014. Patients were divided randomly into two groups. Group A (standard dose) received omeprazole (20 mg), amoxicillin (1 g), and clarithromycin (500 mg), all two times a day for two weeks. Group B received standard dose like group A and in patients with H.pylori infection amoxicillin were continued for 4 weeks. After completion of treatment, patients did not receive any treatment for a month and then stool antigen was performed to evaluate the H.pylori. Results: The rate of successful HP eradication was significantly higher in group A (90.9% V.s 63.6%; p=0.017). Inflation and bitter mouth were found in 8 and 13 patients in group A and 7 and 9 patients in group B, respectively. The incidence of adverse effects was the same (p=0.437). Conclusion: Increased duration of antibiotic therapy to four weeks significantly raises the rate of successful HP eradication with standard triple therapy without significant increase in adverse effects. PMID:26171138

  13. Racial Differences in Response to Antiretroviral Therapy for HIV Infection: An AIDS Clinical Trials Group (ACTG) Study Analysis

    PubMed Central

    Ribaudo, Heather J.; Smith, Kimberly Y.; Robbins, Gregory K.; Flexner, Charles; Haubrich, Richard; Chen, Yun; Fischl, Margaret A.; Schackman, Bruce R.; Riddler, Sharon A.; Gulick, Roy M.

    2013-01-01

    Background.?In the United States, black individuals infected with human immunodeficiency virus (HIV) have higher rates of virologic failure on antiretroviral therapy (ART) and of death compared to white individuals. The cause for these disparities is uncertain. We sought to examine differences in virologic outcomes among antiretroviral-naive clinical trial participants starting randomized ART and to investigate factors to explain the differences. Methods.?Individual-level data from participants initiating ART in 5 AIDS Clinical Trials Group studies were analyzed. Included studies were those conducted during 1998–2006 with a primary outcome of virologic failure. The primary outcome measure was time to virologic failure, regardless of ART changes. Results.?A total of 2495 individuals (1151 black; 1344 white) were included with a median follow-up of 129 weeks. Compared to whites, blacks had an increased hazard of virologic failure (hazard ratio [HR]; 1.7; 95% confidence interval [CI], 1.4–1.9; P < .001), with no evidence of heterogeneity across regimens (P = .97); the association remained after adjustment for measured confounders (HR, 1.4; 95% CI, 1.2–1.6; P < .001). Increased hazard of virologic failure was associated with younger age, higher pretreatment HIV type 1 RNA level, lower pretreatment CD4 cell count, hepatitis C antibody, less education, and recent nonadherence to treatment. Sensitivity analyses with different endpoint definitions demonstrated similar results. Conclusions.?In this analysis, blacks had a 40% higher virologic failure risk than whites that was not explained by measured confounders. The observation was consistent over a range of regimens, suggesting that the difference may be driven by social factors; however, biological factors cannot be ruled out. Further research should identify the sources of racial disparities and develop strategies to reduce them. PMID:24046302

  14. Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol

    PubMed Central

    Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

    2015-01-01

    Background: In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. Patients and Methods: This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. Discussion: This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article. PMID:26251659

  15. Cooperative Group Trials in the Community Setting.

    PubMed

    Lloyd Wade, James; Petrelli, Nicholas J; McCaskill-Stevens, Worta

    2015-10-01

    Over the last 40 years the National Cancer Institute (NCI) has created a vibrant public-private partnership for the implementation of NCI-sponsored cooperative group (Network) clinical trials throughout the United States and Canada. Over these four decades, the cancer clinical trials process has become more complex more precise and more resource intensive. During this same time period, financial resources to support the NCI community research initiative have become more constrained. The newest manifestation of NCI-sponsored community based cancer clinical trial research, known as the National Community Oncology Research Program (NCORP) began initial operation August 1, 2014. We describe several key strategies that community sites may use to not only be successful but to thrive in this new financially austere research environment. PMID:26433550

  16. Regression to the mean and alcohol consumption: A cohort study exploring implications for the interpretation of change in control groups in brief intervention trials?

    PubMed Central

    McCambridge, Jim; Kypri, Kypros; McElduff, Patrick

    2014-01-01

    Background Reductions in drinking among individuals randomised to control groups in brief alcohol intervention trials are common and suggest that asking study participants about their drinking may itself cause them to reduce their consumption. We sought to test the hypothesis that the statistical artefact regression to the mean (RTM) explains part of the reduction in such studies. Methods 967 participants in a cohort study of alcohol consumption in New Zealand provided data at baseline and again six months later. We use graphical methods and apply thresholds of 8, 12, 16 and 20 in AUDIT scores to explore RTM. Results There was a negative association between baseline AUDIT scores and change in AUDIT scores from baseline to six months, which in the absence of bias and confounding, is RTM. Students with lower baseline scores tended to have higher follow-up scores and conversely, those with higher baseline scores tended to have lower follow-up scores. When a threshold score of 8 was used to select a subgroup, the observed mean change was approximately half of that observed without a threshold. The application of higher thresholds produced greater apparent reductions in alcohol consumption. Conclusions Part of the reduction seen in the control groups of brief alcohol intervention trials is likely to be due to RTM and the amount of change is likely to be greater as the threshold for entry to the trial increases. Quantification of RTM warrants further study and should assist understanding assessment and other research participation effects. PMID:24342421

  17. Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial

    PubMed Central

    Schag, Kathrin; Leehr, Elisabeth J; Martus, Peter; Bethge, Wolfgang; Becker, Sandra; Zipfel, Stephan; Giel, Katrin E

    2015-01-01

    Introduction The core symptom of binge eating disorder (BED) is recurrent binge eating that is accompanied by a sense of loss of control. BED is frequently associated with obesity, one of the main public health challenges today. Experimental studies deliver evidence that general trait impulsivity and disorder-specific food-related impulsivity constitute risk factors for BED. Cognitive-behavioural treatment (CBT) is deemed to be the most effective intervention concerning BED. We developed a group intervention based on CBT and especially focusing on impulsivity. We hypothesise that such an impulsivity-focused group intervention is able to increase control over impulsive eating behaviour, that is, reduce binge eating episodes, further eating pathology and impulsivity. Body weight might also be influenced in the long term. Methods and analysis The present randomised controlled trial investigates the feasibility, acceptance and efficacy of this impulsivity-focused group intervention in patients with BED. We compare 39 patients with BED in the experimental group to 39 patients with BED in the control group at three appointments: before and after the group intervention and in a 3-month follow-up. Patients with BED in the experimental group receive 8 weekly sessions of the impulsivity-focused group intervention with 5-6 patients per group. Patients with BED in the control group receive no group intervention. The primary outcome is the binge eating frequency over the past 4?weeks. Secondary outcomes comprise further eating pathology, general impulsivity and food-related impulsivity assessed by eye tracking methodology, and body weight. Additionally, we assess binge eating and other impulsive behaviour weekly in process analyses during the time period of the group intervention. Ethics and dissemination This study has been approved by the ethics committee of the medical faculty of Eberhard Karls University Tübingen and the University Hospital Tübingen. Data are monitored by the Centre of Clinical Studies, University Hospital Tübingen. Trial registration number German Clinical Trials Register, DRKS00007689, 14/01/2015, version from 11/06/2015, pre-results. PMID:26685032

  18. A group-randomized tobacco trial among 30 Pacific Northwest colleges: Results from the Campus Health Action on Tobacco study

    PubMed Central

    McLerran, Dale; Livaudais, Jennifer C.; Coronado, Gloria D.

    2010-01-01

    Introduction: We conducted a group-randomized trial to increase smoking cessation and decrease smoking onset and prevalence in 30 colleges and universities in the Pacific Northwest. Methods: Random samples of students, oversampling for freshmen, were drawn from the participating colleges; students completed a questionnaire that included seven major areas of tobacco policies and behavior. Following this baseline, the colleges were randomized to intervention or control. Three interventionists developed Campus Advisory Boards in the 15 intervention colleges and facilitated intervention activities. The freshmen cohort was resurveyed 1 and 2 years after the baseline. Two-years postrandomization, new cross-sectional samples were drawn, and students were surveyed. Results: At follow-up, we found no significant overall differences between intervention and control schools when examining smoking cessation, prevalence, or onset. There was a significant decrease in prevalence in private independent colleges, a significant increase in cessation among rural schools, and a decrease in smoking onset in urban schools. Discussion: Intervention in this college population had mixed results. More work is needed to determine how best to reach this population of smokers. PMID:20447935

  19. A Phase II Trial and Pharmacokinetic Study of Oxaliplatin in Children with Refractory Solid Tumors: A Children's Oncology Group Study

    PubMed Central

    Beaty, Orren; Berg, Stacey; Blaney, Susan; Malogolowkin, Marcio; Krailo, Mark; Knight, Ronald; Schaiquevich, Paula; Stewart, Clinton; Chen, Zhengjia; Nelson, Marvin; Voss, Stephan; Ivy, S. Percy; Adamson, Peter C.

    2015-01-01

    Background Platinating agents are used in the treatment of a spectrum of childhood cancers. Oxaliplatin, a third generation platinum compound, may provide less toxicity and be more effective. A phase 2 study was performed to estimate the response rate to single agent oxaliplatin in patients with refractory pediatric solid tumors, and to further describe the toxicities and pharmacokinetics of the drug in this population. Patients and Methods Subjects, ? 21 years of age at original diagnosis, received oxaliplatin (130 mg/m2) intravenously every 21 days. Prior platinum exposure was acceptable. Histologies included: Ewing sarcoma/peripheral PNET, osteosarcoma, rhabdomyosarcoma, neuroblastoma, high and low grade astrocytoma, brain stem glioma, ependymoma, hepatoblastoma and selected rare tumors. A two-stage design, enrolling 10+10 subjects, was used for each disease stratum. Limited sampling pharmacokinetic studies were performed. Results Of 124 eligible subjects (75 males), 113 were evaluable for response and 69 (62%) had received platinum previously. Only one objective response was observed, a partial response in a 6 year old child with ependymoma. An additional 13 subjects with various other solid tumors had stable disease, receiving a median (range) of 13.5 (2-17) cycles. Five subjects completed 17 treatment cycles. Thrombocytopenia was the most common toxicity observed. The median (range) terminal half-life and clearance for ultrafiltrable platinum were 293 (187 to 662 hours) and 14.0 (1.9 to 24.9 L/hr/m2), respectively (n=49). Conclusions Although reasonably well tolerated, oxaliplatin administered as a single agent has limited activity in pediatric patients with relapsed or refractory solid tumors. PMID:20658614

  20. Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial

    PubMed Central

    2013-01-01

    Background A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. Methods A parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life – Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery generally, and specific to physical therapy and podiatry treatment, will also be analyzed. Discussion This study will be the first pragmatic trial to investigate the clinical outcomes and cost-effectiveness of ePT and uPOD in individuals with PHP. The results will serve to inform clinical practice decisions and management guidelines of multiple disciplines. Trial registration ClinicalTrials.gov: NCT01865734 PMID:24299257

  1. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    PubMed Central

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. Methods/Design The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. Discussion This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the execution of the program and the resultant threats to the study, we discuss our analytical plan and intentions for endline data collection. Trials registration Current Controlled Trials ISRCTN76061874 PMID:23953975

  2. Study protocol: evaluation of a parenting and stress management programme: a randomised controlled trial of Triple P Discussion Groups and Stress Control

    PubMed Central

    2013-01-01

    Background Children displaying psychosocial problems are at an increased risk of negative developmental outcomes. Parenting practices are closely linked with child development and behaviour, and parenting programmes have been recommended in the treatment of child psychosocial problems. However, parental mental health also needs to be addressed when delivering parenting programmes as it is linked with parenting practices, child outcomes, and treatment outcomes of parenting programmes. This paper describes the protocol of a study examining the effects of a combined intervention of a parenting programme and a cognitive behavioural intervention for mental health problems. Methods/design The effects of a combined intervention of Triple P Discussion Groups and Stress Control will be examined using a randomised controlled trial design. Parents with a child aged 3–8 years will be recruited to take part in the study. After obtaining informed consent and pre-intervention measures, participants will be randomly assigned to either an intervention or a waitlist condition. The two primary outcomes for this study are change in dysfunctional/ineffective parenting practices and change in symptoms of depression, anxiety, and stress. Secondary outcomes are child behaviour problems, parenting experiences, parental self-efficacy, family relationships, and positive parental mental health. Demographic information, participant satisfaction with the intervention, and treatment fidelity data will also be collected. Data will be collected at pre-intervention, mid-intervention, post-intervention, and 3-month follow-up. Discussion The aim of this paper is to describe the study protocol of a randomised controlled trial evaluating the effects of a combined intervention of Triple P Discussion Groups and Stress Control in comparison to a waitlist condition. This study is important because it will provide evidence about the effects of this combined intervention for parents with 3–8 year old children. The results of the study could be used to inform policy about parenting support and support for parents with mental health problems. Trial registration ClinicalTrial.gov: NCT01777724, UTN: U1111-1137-1053. PMID:24066966

  3. Cooperative study group for childhood acute lymphoblastic leukaemia (COALL): long-term results of trials 82,85,89,92 and 97.

    PubMed

    Escherich, G; Horstmann, M A; Zimmermann, M; Janka-Schaub, G E

    2010-02-01

    In this study, the long-term outcome of 1818 patients treated in five consecutive clinical trials (the cooperative study group for childhood acute lymphoblastic leukaemia (COALL) 82, 85, 89, 92 and 97) from 24 cooperating centres in Germany is reported. The probability of event-free survival (pEFS) improved significantly from the first two trials conducted in the 1980s (COALL 82 and COALL 85) to the three trials conducted in the 1990s (COALL 89, 92 and 97) (P=0.001). Through all COALL studies, age > or =10 years and initial white blood cell count (WBC) > or =50 x 10(9)/l and pro-B immunophenotype were of significant prognostic relevance. A refinement of risk assessment has been achieved by in vitro drug sensitivity testing in COALL 92 and 97. In patients with very sensitive leukaemic cells, therapy could be reduced without loss of efficacy. In COALL 97, a further improvement in risk stratification was gained by the molecular assessment of minimal residual disease (MRD) under treatment, which proved to have a superior prognostic effect when compared with in vitro drug sensitivity testing. Importantly, the gradual reduction in central nervous system (CNS) irradiation led to a decreased incidence of brain tumours as a second malignancy. In general, the prevention of treatment-related late effects will be one of the major issues in future studies. It remains to be shown whether prolonged infusions of anthracyclines, which have been implemented into the COALL studies after equal efficacy compared with short-time infusions was confirmed, will be associated with fewer cardiac late effects. Another way to prevent late effects may be a more refined risk assessment allowing for a reduction in cumulative treatment burden. A great challenge in the future will be to improve the overall treatment results, which very likely can only be achieved by the identification of molecularly defined subgroups to which novel, rational therapeutic strategies can be applied. PMID:20016530

  4. Immunopotentiation with levamisole in resectable bronchogenic carcinoma: a double-blind controlled trial; Study Group for Bronchogenic Carcinoma.

    PubMed Central

    1975-01-01

    A long-term multicentre double-blind study was designed to test the immunotropic effects of levamisole in patients undergoing operation for primary bronchial carcinoma. They received levamisole 50 mg three times a day by mouth or placebo for three days every fortnight, starting three days before surgery. Unless there was clinical evidence of recurrence, cytostatic drugs, corticosteroids, and radiotherapy were prohibited. In the 111 patients who have been followed up for one year the incidence of side effects was similar in both groups. Recurrences occurred in 10 out of 51 patients (seven deaths) receiving levamisole and in 20 out of 60 (12 deaths) receiving placebo. Further analysis showed that there were fewer recurrences on levamisole in patients with squamous cell carcinomas and medium and large primary tumours and fewer suspected and proved recurrences and deaths from metastases on levamisole in patients with extended tumours. Distant recurrences tended to be less common with levamisole, whereas the disease-free interval in relapsing patients was almost identical in the two groups. These interim results show that levamisole seems to exert its beneficial effect by preventing immunosuppression due to surgery. PMID:1098727

  5. Attitudes toward participation in breast cancer randomized clinical trials in the African-American community: a focus group study. | accrualnet.cancer.gov

    Cancer.gov

    Focus groups revealed that African-American women are largely positive about breast cancer clinical research, with more than half reporting that they would be interested in participating in a hypothetical trial. Several major issues that influenced these women’s willingness, or unwillingness, to participate in trials were identified. Insights gained may help researchers develop protocols and recruitment procedures that are culturally sensitive and relevant to this population.

  6. Rituximab in relapsed lymphocyte-predominant Hodgkin lymphoma: long-term results of a phase 2 trial by the German Hodgkin Lymphoma Study Group (GHSG).

    PubMed

    Schulz, Holger; Rehwald, Ute; Morschhauser, Franck; Elter, Thomas; Driessen, Christoph; Rüdiger, Thomas; Borchmann, Peter; Schnell, Roland; Diehl, Volker; Engert, Andreas; Reiser, Marcel

    2008-01-01

    Because nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) express CD20, rituximab may be used as a nonmutagenic treatment option to avoid late toxicities in this rather indolent entity. Between 1999 and 2004, the German Hodgkin Study Group (GHSG) investigated the activity of rituximab (375 mg/m(2) in 4 doses) in a phase 2 trial in 21 relapsed or refractory NLPHL patients. The initial diagnosis of NLPHL was confirmed in 15 of the 21 enrolled patients by reference pathology. The remaining cases were reclassified as Hodgkin lymphoma transformed to T-cell rich B-cell lymphoma (TCRBCL; n = 2) or CD20(+) classical Hodgkin lymphoma (cHL; n = 4). In NLPHL patients the overall response rate was 94%, including 8 complete remission (CR) and 6 partial remission (PR). With a median follow-up of 63 months (range, 3-84), the median time to progression was 33 months, with the median overall survival (OS) not reached. Thus, rituximab is highly effective in relapsed and refractory NLPHL. This study is registered at http://www.klinisches-studienzentrum.de/trial/285. PMID:17938252

  7. A randomized placebo-controlled trial of lisofylline in HLA-identical, sibling-donor, allogeneic bone marrow transplant recipients. The Lisofylline Marrow Transplant Study Group.

    PubMed

    List, A F; Maziarz, R; Stiff, P; Jansen, J; Liesveld, J; Andrews, F; Schuster, M; Wolff, S; Litzow, M; Karanes, C; Dahlberg, S; Kirkhart, B; Bianco, J A; Singer, J W

    2000-02-01

    The purpose of the study was to evaluate the effect of lisofylline (LSF) on engraftment, regimen-related toxicities (RRT), and mortality in patients undergoing allogeneic bone marrow transplantation (BMT). We performed a multicenter, randomized placebo-controlled trial in 60 patients with hematologic malignancies receiving BMT from HLA-identical sibling donors. Patients were randomized to receive either placebo, 2 mg/kg LSF or 3 mg/kg LSF every 6 h, beginning before conditioning and continuing to day 21 or hospital discharge. Treatment groups were balanced with respect to conditioning regimen and disease stage. However, significantly more patients in the 2 mg/kg LSF group were at high risk for RRT due to performance status >/=1, age >/=40 years, and prior exposure to CMV. Nausea and vomiting were the only adverse events observed in a higher proportion of LSF-treated patients that led to study withdrawal in six of 42 patients (14%). The times to neutrophil recovery to >/=500/microl and platelet recovery (>20 000/microl) were not improved by LSF treatment. Nevertheless, no patient who received treatment with 3 mg/kg LSF developed a documented infection between day 0 and 35 or had a serious or fatal infection between day 0 and 100 (P = 0.003 vs placebo for both). The day-100 survival rate was also significantly improved in the 3 mg/kg LSF group (89%), compared with either the 2 mg/kg LSF (48%) or placebo (61%) groups (log-rank test, 3 mg/kg LSF vs placebo, P = 0. 026). We conclude that treatment with LSF 3 mg/kg reduced the incidence of infections and improved 100-day survival in patients receiving related-donor allogeneic bone marrow transplantation. Bone Marrow Transplantation (2000) 25, 283-291. PMID:10673700

  8. Effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care: study protocol of a three-arm parallel-group randomized controlled trial

    PubMed Central

    2014-01-01

    Background Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, aiming to evaluate and, if necessary, adapt treatment. Clients fill out questionnaires and clinicians receive feedback about the results. Studies concerning feedback in youth mental health care are rare. The effects of feedback, the importance of specific aspects of feedback, and the mechanisms underlying the effects of feedback are unknown. In the present study, several potentially effective components of feedback from Routine Outcome Monitoring in youth mental health care in the Netherlands are investigated. Methods/Design We will examine three different forms of feedback through a three-arm parallel-group randomized controlled trial. 432 children and adolescents (aged 4 to 17 years) and their parents, who have been referred to mental health care institution Pro Persona, will be randomly assigned to one of three feedback conditions (144 participants per condition). Randomization will be stratified by age of the child or adolescent and by department. All participants fill out questionnaires at the start of treatment, one and a half months after the start of treatment, every three months during treatment, and at the end of treatment. Participants in the second and third feedback conditions fill out an additional questionnaire. In condition 1, clinicians receive basic feedback regarding clients’ symptoms and quality of life. In condition 2, the feedback of condition 1 is extended with feedback regarding possible obstacles to a good outcome and with practical suggestions. In condition 3, the feedback of condition 2 is discussed with a colleague while following a standardized format for case consultation. The primary outcome measure is symptom severity and secondary outcome measures are quality of life, satisfaction with treatment, number of sessions, length of treatment, and rates of dropout. We will also examine the role of being not on track (not responding to treatment). Discussion This study contributes to the identification of effective components of feedback and a better understanding of how feedback functions in real-world clinical practice. If the different feedback components prove to be effective, this can help to support and improve the care for youth. Trial registration Dutch Trial Register NTR4234 PMID:24393491

  9. Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): a randomized, open-label, parallel-group trial

    PubMed Central

    Toyoda, Kazunori; Uchiyama, Shinichiro; Hoshino, Haruhiko; Kimura, Kazumi; Origasa, Hideki; Naritomi, Hiroaki; Minematsu, Kazuo; Yamaguchi, Takenori

    2015-01-01

    Rationale and aims Monotherapy with antiplatelet agents is only modestly effective in secondary prevention of ischemic stroke (IS), particularly in patients with multiple risk factors such as cervicocephalic arterial stenosis, diabetes, and hypertension. While dual antiplatelet therapy (DAPT) with aspirin and clopidogrel reduced IS recurrence, particularly in the early stages after IS, it increased the risk of bleeding. Compared with aspirin, cilostazol prevented IS recurrence without increasing the incidence of serious bleeds. In patients with intracranial arterial stenosis, no significant increase in bleeding events was observed for DAPT with cilostazol and aspirin, compared to that for aspirin monotherapy. DAPT involving cilostazol may therefore be safer than conventional DAPT. These findings prompted us to conduct the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com; ClinicalTrials.gov identifier: NCT01995370) to evaluate the safety and efficacy of DAPT involving cilostazol for secondary IS prevention, in comparison with that of antiplatelet monotherapy. Design The CSPS.com is a multicenter, randomized, open-label, parallel-group trial. A total of 4000 high-risk patients with noncardioembolic IS will be randomized 8–180 days after onset to receive aspirin or clopidogrel monotherapy, or DAPT with cilostazol and aspirin or clopidogrel for at least one-year. Study outcomes The primary outcome is IS recurrence. Secondary outcomes are composite occurrences of any stroke, death from any cause, myocardial infarction, vascular death, and other vascular events. Discussion The CSPS.com is expected to provide evidence indicating whether secondary IS prevention in high-risk patients can be improved by using DAPT involving cilostazol. PMID:25487817

  10. The Impact of Trauma-Focused Group Therapy upon HIV Sexual Risk Behaviors in the NIDA Clinical Trials Network “Women and Trauma” Multi-Site Study

    PubMed Central

    Campbell, Aimee N. C.; Killeen, Therese; Hu, Mei-Chen; Hansen, Cheri; Jiang, Huiping; Hatch-Maillette, Mary; Miele, Gloria M.; Cohen, Lisa R.; Gan, Weijin; Resko, Stella M.; DiBono, Michele; Wells, Elizabeth A.; Nunes, Edward V.

    2009-01-01

    Women in drug treatment struggle with co-occurring problems, including trauma and posttraumatic stress disorder (PTSD), which can heighten HIV risk. This study examines the impact of two group therapy interventions on reduction of unprotected sexual occasions (USO) among women with substance use disorders (SUD) and PTSD. Participants were 346 women recruited from and receiving treatment at six community-based drug treatment programs participating in NIDA’s Clinical Trials Network. Participants were randomized to receive 12-sessions of either seeking safety (SS), a cognitive behavioral intervention for women with PTSD and SUD, or women’s health education (WHE), an attention control psychoeducational group. Participants receiving SS who were at higher sexual risk (i.e., at least 12 USO per month) significantly reduced the number of USO over 12-month follow up compared to WHE. High risk women with co-occurring PTSD and addiction may benefit from treatment addressing coping skills and trauma to reduce HIV risk. PMID:19452271

  11. Evaluating the Effect of Early Versus Late ARV Regimen Change if Failure on an Initial Regimen: Results From the AIDS Clinical Trials Group Study A5095

    PubMed Central

    Li, Li; Eron, Joseph J.; Ribaudo, Heather; Gulick, Roy M.; Johnson, Brent A.

    2012-01-01

    The current goal of initial antiretroviral (ARV) therapy is suppression of plasma human immunodeficiency virus (HIV)-1 RNA levels to below 200 copies per milliliter. A proportion of HIV-infected patients who initiate antiretroviral therapy in clinical practice or antiretroviral clinical trials either fail to suppress HIV-1 RNA or have HIV-1 RNA levels rebound on therapy. Frequently, these patients have sustained CD4 cell counts responses and limited or no clinical symptoms and, therefore, have potentially limited indications for altering therapy which they may be tolerating well despite increased viral replication. On the other hand, increased viral replication on therapy leads to selection of resistance mutations to the antiretroviral agents comprising their therapy and potentially cross-resistance to other agents in the same class decreasing the likelihood of response to subsequent antiretroviral therapy. The optimal time to switch antiretroviral therapy to ensure sustained virologic suppression and prevent clinical events in patients who have rebound in their HIV-1 RNA, yet are stable, is not known. Randomized clinical trials to compare early versus delayed switching have been difficult to design and more difficult to enroll. In some clinical trials, such as the AIDS Clinical Trials Group (ACTG) Study A5095, patients randomized to initial antiretroviral treatment combinations, who fail to suppress HIV-1 RNA or have a rebound of HIV-1 RNA on therapy are allowed to switch from the initial ARV regimen to a new regimen, based on clinician and patient decisions. We delineate a statistical framework to estimate the effect of early versus late regimen change using data from ACTG A5095 in the context of two-stage designs. In causal inference, a large class of doubly robust estimators are derived through semiparametric theory with applications to missing data problems. This class of estimators is motivated through geometric arguments and relies on large samples for good performance. By now, several authors have noted that a doubly robust estimator may be suboptimal when the outcome model is misspecified even if it is semiparametric efficient when the outcome regression model is correctly specified. Through auxiliary variables, two-stage designs, and within the contextual backdrop of our scientific problem and clinical study, we propose improved doubly robust, locally efficient estimators of a population mean and average causal effect for early versus delayed switching to second-line ARV treatment regimens. Our analysis of the ACTG A5095 data further demonstrates how methods that use auxiliary variables can improve over methods that ignore them. Using the methods developed here, we conclude that patients who switch within 8 weeks of virologic failure have better clinical outcomes, on average, than patients who delay switching to a new second-line ARV regimen after failing on the initial regimen. Ordinary statistical methods fail to find such differences. This article has online supplementary material. PMID:23329858

  12. Group CBT for psychosis: a longitudinal, controlled trial with inpatients.

    PubMed

    Owen, Mary; Sellwood, William; Kan, Stephen; Murray, John; Sarsam, May

    2015-02-01

    Individual cognitive behaviour therapy for psychosis (CBTp) is a recommended treatment in the acute phase and beyond. However, less is known about the effectiveness of group CBTp in acute care. This mixed methods study explored the implementation and effectiveness of brief group CBTp with inpatients. This prospective trial compared inpatients who received either a four week group CBTp program or treatment as usual (TAU). Participants (n = 113 at baseline) completed self-report measures of distress, confidence and symptoms of psychosis at baseline, post-intervention and one month follow up. CBTp group participants also completed a brief open-ended satisfaction questionnaire. Using complete case analysis participants who received CBTp showed significantly reduced distress at follow up compared to TAU and significantly increased confidence across the study and follow up period. However, these effects were not demonstrated using a more conservative intention-to-treat analysis. Qualitative analysis of the satisfaction data revealed positive feedback with a number of specific themes. The study suggests that brief group CBTp with inpatients may improve confidence and reduce distress in the longer term. Participants report that the groups are acceptable and helpful. However, given the methodological limitations involved in this 'real world' study more robust evidence is needed. PMID:25577190

  13. Group Lidcombe Program Treatment for Early Stuttering: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Arnott, Simone; Onslow, Mark; O'Brian, Sue; Packman, Ann; Jones, Mark; Block, Susan

    2014-01-01

    Purpose: This study adds to the Lidcombe Program evidence base by comparing individual and group treatment of preschoolers who stutter. Method: A randomized controlled trial of 54 preschoolers was designed to establish whether group delivery outcomes were not inferior to the individual model. The group arm used a rolling group model, in which a…

  14. Exploring recruitment barriers and facilitators in early cancer detection trials: the use of pre-trial focus groups

    PubMed Central

    2014-01-01

    Background Recruiting to randomized controlled trials is fraught with challenges; with less than one third recruiting to their original target. In preparation for a trial evaluating the effectiveness of a blood test to screen for lung cancer (the ECLS trial), we conducted a qualitative study to explore the potential barriers and facilitators that would impact recruitment. Methods Thirty two people recruited from community settings took part in four focus groups in Glasgow and Dundee (UK). Thematic analysis was used to code the data and develop themes. Results Three sub-themes were developed under the larger theme of recruitment strategies. The first of these themes, recruitment options, considered that participants largely felt that the invitation to participate letter should come from GPs, with postal reminders and face-to-face reminders during primary care contacts. The second theme dealt with understanding randomization and issues related to the control group (where bloods were taken but not tested). Some participants struggled with the concept or need for randomization, or for the need for a control group. Some reported that they would not consider taking part if allocated to the control group, but others were motivated to take part even if allocated to the control group by altruism. The final theme considered perceived barriers to participation and included practical barriers (such as flexible appointments and reimbursement of travel expenses) and psychosocial barriers (such as feeling stigmatized because of their smoking status and worries about being coerced into stopping smoking). Conclusions Focus groups provided useful information which resulted in numerous changes to proposed trial documentation and processes. This was in order to address participants information needs, improve comprehension of the trial documentation, enhance facilitators and remove barriers to participation. The modifications made in light of these findings may enhance trial recruitment and future trials may wish to consider use of pretrial focus groups. PMID:24678918

  15. Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer

    PubMed Central

    Viale, G.; Giobbie-Hurder, A.; Gusterson, B. A.; Maiorano, E.; Mastropasqua, M. G.; Sonzogni, A.; Mallon, E.; Colleoni, M.; Castiglione-Gertsch, M.; Regan, M. M.; Brown, R. W.; Golouh, R.; Crivellari, D.; Karlsson, P.; Öhlschlegel, C.; Gelber, R. D.; Goldhirsch, A.; Coates, A. S.

    2010-01-01

    Background: Peritumoral vascular invasion (PVI) may assist in assigning optimal adjuvant systemic therapy for women with early breast cancer. Patients and methods: Patients participated in two International Breast Cancer Study Group randomized trials testing chemoendocrine adjuvant therapies in premenopausal (trial VIII) or postmenopausal (trial IX) node-negative breast cancer. PVI was assessed by institutional pathologists and/or central review on hematoxylin–eosin-stained slides in 99% of patients (analysis cohort 2754 patients, median follow-up >9 years). Results: PVI, present in 23% of the tumors, was associated with higher grade tumors and larger tumor size (trial IX only). Presence of PVI increased locoregional and distant recurrence and was significantly associated with poorer disease-free survival. The adverse prognostic impact of PVI in trial VIII was limited to premenopausal patients with endocrine-responsive tumors randomized to therapies not containing goserelin, and conversely the beneficial effect of goserelin was limited to patients whose tumors showed PVI. In trial IX, all patients received tamoxifen: the adverse prognostic impact of PVI was limited to patients with receptor-negative tumors regardless of chemotherapy. Conclusion: Adequate endocrine adjuvant therapy appears to abrogate the adverse impact of PVI in node-negative disease, while PVI may identify patients who will benefit particularly from adjuvant therapy. PMID:19633051

  16. Choosing a Control Group in Effectiveness Trials of Behavioral Drug Abuse Treatments

    PubMed Central

    Brigham, Gregory S.; Feaster, Daniel J.; Wakim, Paul G.; Dempsey, Catherine L.

    2009-01-01

    Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial's internal and external validity. The purpose of this manuscript is to provide a discussion of the issues involved in choosing a control group for effectiveness trials of behavioral interventions in substance abuse treatment. The authors provide a description of four trial designs and a discussion of the advantages and disadvantages of each. PMID:19553062

  17. Structure, process and annual intensive care unit mortality across 69 centers: United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS)

    PubMed Central

    Checkley, William; Martin, Greg S; Brown, Samuel M; Chang, Steven Y; Dabbagh, Ousama; Fremont, Richard D; Girard, Timothy D; Rice, Todd W; Howell, Michael D; Johnson, Steven B; O'Brien, James; Park, Pauline K; Pastores, Stephen M; Patil, Namrata T; Pietropaoli, Anthony P; Putman, Maryann; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Sevransky, Jonathan E

    2014-01-01

    Objective Hospital-level variations in structure and process may affect clinical outcomes in intensive care units (ICUs). We sought to characterize the organizational structure, processes of care, use of protocols and standardized outcomes in a large sample of U.S. ICUs. Design We surveyed 69 ICUs about organization, size, volume, staffing, processes of care, use of protocols, and annual ICU mortality. Setting ICUs participating in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study (USCIITG-CIOS). Measurements and Main Results We characterized structure and process variables across ICUs, investigated relationships between these variables and annual ICU mortality, and adjusted for illness severity using APACHE II. Ninety-four ICU directors were invited to participate in the study and 69 ICUs (73%) were enrolled, of which 25 (36%) were medical, 24 were surgical (35%) and 20 (29%) were of mixed type, and 64 (93%) were located in teaching hospitals with a median number of 5 trainees per ICU. Average annual ICU mortality was 10.8%, average APACHE II score was 19.3, 58% were closed units and 41% had a 24-hour in-house intensivist. In multivariable linear regression adjusted for APACHE II and multiple ICU structure and process factors, annual ICU mortality was lower in surgical ICUs than in medical ICUs (5.6% lower, 95% CI 2.4%–8.8%) or mixed ICUs (4.5% lower, 95% CI 0.4%–8.7%). We also found a lower annual ICU mortality among ICUs that had a daily plan of care review (5.8% lower, 95% CI 1.6%–10.0%) and a lower bed-to-nurse ratio (1.8% lower when the ratio decreased from 2:1 to 1.5:1; 95% CI 0.25%–3.4%). In contrast, 24-hour intensivist coverage (p=0.89) and closed ICU status (p=0.16) were not associated with a lower annual ICU mortality. Conclusions In a sample of 69 ICUs, a daily plan of care review and a lower bed-to-nurse ratio were both associated with a lower annual ICU mortality. In contrast to 24-hour intensivist staffing, improvement in team communication is a low-cost, process-targeted intervention strategy that may improve clinical outcomes in ICU patients. PMID:24145833

  18. GRIN: “GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: an assessor-masked randomised comparison trial”: study protocol

    PubMed Central

    2014-01-01

    Background Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years. Methods/Design An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child’s occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health. Discussion This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus individual models of physiotherapy following intramuscular injections of Botulinum Toxin-A to the lower limbs for ambulant children with cerebral palsy. Trial registration ACTRN12611000454976 PMID:24502231

  19. Teachable Trials in the Social Studies Classroom

    ERIC Educational Resources Information Center

    Weiner, Mark S.

    2010-01-01

    At the heart of the Western intellectual tradition, particularly the value it places on the critical analysis of civic life, or social studies, lies the story of a trial. If the story of a trial lies at the root of social studies, then it comes as no surprise that many teachers find that trials can serve as excellent teaching tools, especially for…

  20. A phase III randomized trial of postoperative pelvic irradiation in stage IB cervical carcinoma with poor prognostic features: Follow-up of a gynecologic oncology group study

    SciTech Connect

    Rotman, Marvin . E-mail: mrotman@downstate.edu; Sedlis, Alexander; Piedmonte, Marion R.; Bundy, Brian; Lentz, Samuel S.; Muderspach, Laila I.; Zaino, Richard J.

    2006-05-01

    Purpose: To investigate, in a phase III randomized trial, whether postoperative external-beam irradiation to the standard pelvic field improves the recurrence-free interval and overall survival (OS) in women with Stage IB cervical cancers with negative lymph nodes and certain poor prognostic features treated by radical hysterectomy and pelvic lymphadenectomy. Methods and Materials: Eligible patients had Stage IB cervical cancer with negative lymph nodes but with 2 or more of the following features: more than one third (deep) stromal invasion, capillary lymphatic space involvement, and tumor diameter of 4 cm or more. The study group included 277 patients: 137 randomized to pelvic irradiation (RT) and 140 randomized to observation (OBS). The planned pelvic dose was from 46 Gy in 23 fractions to 50.4 Gy in 28 fractions. Results: Of the 67 recurrences, 24 were in the RT arm and 43 were in the OBS arm. The RT arm showed a statistically significant (46%) reduction in risk of recurrence (hazard ratio [HR] = 0.54, 90% confidence interval [CI] = 0.35 to 0.81, p = 0.007) and a statistically significant reduction in risk of progression or death (HR = 0.58, 90% CI = 0.40 to 0.85, p = 0.009). With RT, 8.8% of patients (3 of 34) with adenosquamous or adenocarcinoma tumors recurred vs. 44.0% (11 of 25) in OBS. Fewer recurrences were seen with RT in patients with adenocarcinoma or adenosquamous histologies relative to others (HR for RT by histology interaction = 0.23, 90% CI = 0.07 to 0.74, p = 0.019). After an extensive follow-up period, 67 deaths have occurred: 27 RT patients and 40 OBS patients. The improvement in overall survival (HR = 0.70, 90% CI = 0.45 to 1.05, p = 0.074) with RT did not reach statistical significance. Conclusions: Pelvic radiotherapy after radical surgery significantly reduces the risk of recurrence and prolongs progression-free survival in women with Stage IB cervical cancer. RT appears to be particularly beneficial for patients with adenocarcinoma or adenosquamous histologies. Circumstances that may have influenced the overall survival differences are considered.

  1. A clinical evaluation of risperidone in the treatment of schizophrenia: a 10-week, open-label, multicenter trial. ARCS Study Group. Assessment of Risperdal in a Clinical Setting.

    PubMed

    Jeste, D V; Klausner, M; Brecher, M; Clyde, C; Jones, R

    1997-06-01

    The efficacy and safety of risperidone have previously been demonstrated in controlled clinical trials in hospitalized chronic schizophrenia patients who met strict research criteria. The present study was designed to evaluate the efficacy and safety of risperidone in a heterogeneous patient population. Patients were enrolled in the study if they had a diagnosis of schizophrenia (DSM-III-R) with or without acute exacerbation. Of the 945 patients from 158 psychiatric centers who entered this phase IV study, 558 completed the 10-week trial. During week 1, the dose of risperidone was titrated to 6 mg/day, maintained there for 1 week, and then adjusted over a 4-week period as clinically necessary; the dose was then fixed for the final 4-week period. The mean dose of risperidone at endpoint was 5.9 mg/day. Patients were evaluated at baseline and at weeks 2, 6, and 10, using Clinical Global Impression scale, Psychotic Symptoms Assessment scale, and Global Assessment of Functioning scale. Significant improvement in mean scores was found on each of these measures at endpoint. Comparable results were obtained at week 10 in treatment-resistant and non-treatment-resistant patients. Risperidone was generally well tolerated and the severity of extrapyramidal symptoms was significantly reduced at endpoint. PMID:9203234

  2. A phase II trial of combination of CPT-11 and cisplatin for advanced non-small-cell lung cancer. CPT-11 Lung Cancer Study Group.

    PubMed Central

    Masuda, N.; Fukuoka, M.; Fujita, A.; Kurita, Y.; Tsuchiya, S.; Nagao, K.; Negoro, S.; Nishikawa, H.; Katakami, N.; Nakagawa, K.; Niitani, H.

    1998-01-01

    A phase I trial of the combination of irinotecan (CPT-11) with cisplatin in advanced non-small cell lung cancer (NSCLC) showed a very promising response rate of 54% in previously untreated NSCLC patients. This study was conducted to confirm the activity and toxicities of CPT-11 and cisplatin combination for previously untreated NSCLC in a multi-institutional phase II study. Seventy patients with stage IIIB or IV NSCLC received CPT-11 60 mg m(-2) intravenously (i.v.) on days 1, 8 and 15, and cisplatin 80 mg m(-2) (i.v.) on day 1 every 4 weeks. Assessments were made of response, survival and toxicities. Sixty-nine were eligible, and evaluable for toxicities and survival, and 64 patients evaluable for response. Thirty-three patients (52%; 95% confidence interval 39-64%) achieved an objective response, with one complete response (2%) and 32 partial responses (50%). The median duration of response was 19 weeks and the overall median survival time was 44 weeks. The 1-year survival rate was 33%. The major toxic effects were leucopenia and diarrhoea. Grade 3 or 4 leucopenia, neutropenia, and diarrhoea occurred in 32 patients (46%), 53 patients (80%), and 13 patients (19%) respectively. A combination of CPT-11 and cisplatin is very effective against non-small-cell lung cancer with acceptable toxicities. PMID:9683302

  3. Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study)

    PubMed Central

    2014-01-01

    Background The possibility of living well with a long-term condition has been identified as centrally relevant to the needs of people living with dementia. Growing numbers of people with early-stage dementia are contributing accounts that emphasise the benefits of actively engaging in managing the condition. Self-management interventions share the common objectives of educating about the condition, optimising well-being, enhancing control over the situation and enabling people to take more responsibility for managing the condition. Benefits of such an approach can include improved knowledge, self-efficacy, health status, and better performance of self-management behaviours. However, there is only preliminary evidence that people with early-stage dementia can benefit from such interventions. Methods This feasibility study involves the development of a self-management group intervention for people with early-stage Alzheimer’s disease, vascular dementia or mixed Alzheimer’s and vascular dementia. This study is a single-site pilot randomised-controlled trial. Forty-two people with early stage dementia, each with a caregiver (family member/friend), will be randomised to either the self-management group intervention or to treatment as usual. The self-management group intervention will involve eight weekly sessions, each lasting 90 minutes, held at a memory clinic in North Wales. All participants will be re-assessed three and six months post-randomisation. This study is intended to supply an early evaluation of the self-management intervention so that a full scale trial may be powered from the best available evidence. It will assess the feasibility of the intervention, the study design and the recruitment strategies. It will estimate the parameters and confidence intervals for the research questions of interest. The primary outcome of interest is the self-efficacy score of the person with dementia at three months post-randomisation. Secondary outcomes for the person with dementia are self-efficacy at six months post-randomisation and cognitive ability, mood and well-being at three and six months post-randomisation. Secondary outcomes for caregivers are their distress and stress at three and six months post-randomisation. The cost-effectiveness of the intervention will also be examined. Discussion This study will provide preliminary information about the feasibility, efficacy and cost-effectiveness of a self-management group intervention for people in the early stages of dementia. Trial registration Current Controlled Trials, ISRCTN02023181. PMID:24606601

  4. Treatment of severe pneumonia in hospitalized patients: results of a multicenter, randomized, double-blind trial comparing intravenous ciprofloxacin with imipenem-cilastatin. The Severe Pneumonia Study Group.

    PubMed Central

    Fink, M P; Snydman, D R; Niederman, M S; Leeper, K V; Johnson, R H; Heard, S O; Wunderink, R G; Caldwell, J W; Schentag, J J; Siami, G A

    1994-01-01

    Intravenously administered ciprofloxacin was compared with imipenem for the treatment of severe pneumonia. In this prospective, randomized, double-blind, multicenter trial, which included an intent-to-treat analysis, a total of 405 patients with severe pneumonia were enrolled. The mean APACHE II score was 17.6, 79% of the patients required mechanical ventilation, and 78% had nosocomial pneumonia. A subgroup of 205 patients (98 ciprofloxacin-treated patients and 107 imipenem-treated patients) were evaluable for the major efficacy endpoints. Patients were randomized to receive intravenous treatment with either ciprofloxacin (400 mg every 8 h) or imipenem (1,000 mg every 8 h), and doses were adjusted for renal function. The primary and secondary efficacy endpoints were bacteriological and clinical responses at 3 to 7 days after completion of therapy. Ciprofloxacin-treated patients had a higher bacteriological eradication rate than did imipenem-treated patients (69 versus 59%; 95% confidence interval of -0.6%, 26.2%; P = 0.069) and also a significantly higher clinical response rate (69 versus 56%; 95% confidence interval of 3.5%, 28.5%; P = 0.021). The greatest difference between ciprofloxacin and imipenem was in eradication of members of the family Enterobacteriaceae (93 versus 65%; P = 0.009). Stepwise logistic regression analysis demonstrated the following factors to be associated with bacteriological eradication: absence of Pseudomonas aeruginosa (P < 0.01), higher weight (P < 0.01), a low APACHE II score (P = 0.03), and treatment with ciprofloxacin (P = 0.04). When P. aeruginosa was recovered from initial respiratory tract cultures, failure to achieve bacteriological eradication and development of resistance during therapy were common in both treatment groups (67 and 33% for ciprofloxacin and 59 and 53% for imipenem, respectively). Seizures were observed more frequently with imipenem than with ciprofloxacin (6 versus 1%; P = 0.028). These results demonstrate that in patients with severe pneumonia, monotherapy with ciprofloxacin is at least equivalent to monotherapy with imipenem in terms of bacteriological eradication and clinical response. For both treatment groups, the presence of P. aeruginosa had a negative impact on treatment success. Seizures were more common with imipenem than with ciprofloxacin. Monotherapy for severe pneumonia is a safe and effective initial strategy but may need to be modified if P. aeruginosa is suspected or recovered from patients. PMID:8203853

  5. A Phase II Study of Intensity Modulated Radiation Therapy to the Pelvis for Postoperative Patients With Endometrial Carcinoma: Radiation Therapy Oncology Group Trial 0418

    SciTech Connect

    Jhingran, Anuja; Winter, Kathryn; Portelance, Lorraine; Miller, Brigitte; Salehpour, Mohammad; Gaur, Rakesh; Souhami, Luis; Small, William; Berk, Lawrence; Gaffney, David

    2012-09-01

    Purpose: To determine the feasibility of pelvic intensity modulated radiation therapy (IMRT) for patients with endometrial cancer in a multi-institutional setting and to determine whether this treatment is associated with fewer short-term bowel adverse events than standard radiation therapy. Methods: Patients with adenocarcinoma of the endometrium treated with pelvic radiation therapy alone were eligible. Guidelines for target definition and delineation, dose prescription, and dose-volume constraints for the targets and critical normal structures were detailed in the study protocol and a web-based atlas. Results: Fifty-eight patients were accrued by 25 institutions; 43 were eligible for analysis. Forty-two patients (98%) had an acceptable IMRT plan; 1 had an unacceptable variation from the prescribed dose to the nodal planning target volume. The proportions of cases in which doses to critical normal structures exceeded protocol criteria were as follows: bladder, 67%; rectum, 76%; bowel, 17%; and femoral heads, 33%. Twelve patients (28%) developed grade {>=}2 short-term bowel adverse events. Conclusions: Pelvic IMRT for endometrial cancer is feasible across multiple institutions with use of a detailed protocol and centralized quality assurance (QA). For future trials, contouring of vaginal and nodal tissue will need continued monitoring with good QA and better definitions will be needed for organs at risk.

  6. Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation. Ventriculomegaly Trial Group.

    PubMed Central

    1990-01-01

    Treatment of posthaemorrhagic ventricular dilatation by early repeated cerebrospinal fluid taps was compared with conservative management in a randomised controlled trial of 157 infants in 15 centres. Thirty infants died and six moved abroad before follow up. During the first 14 days after randomisation, the early treatment group had five times more taps, and 12 times more cerebrospinal fluid removed. Infection of the cerebrospinal fluid occurred in seven of the early treated and four of the conservatively managed infants. Of survivors, 62% in both groups ultimately had ventricular shunts. Neurodevelopmental assessment of survivors at 12 months was carried out by a single experienced examiner. Of survivors, 103 (85%) had abnormal neuromotor signs and 88 (73%) had disabilities. There was no detectable benefit of early treatment for children who did not have parenchymal lesions at the time they entered the trial. Nearly all those with parenchymal lesions had neuromotor impairment, but early treatment was associated with a significant reduction in other impairments. PMID:2407200

  7. Facilitating Teacher Study Groups

    ERIC Educational Resources Information Center

    Walpole, Sharon; Beauchat, Katherine A.

    2008-01-01

    Although literacy coaching means many different things, all coaching initiatives have one common commitment: the goal of building teacher expertise. In the authors' work as coaches and with coaches, they have relied on teacher study groups as a main strategy for accomplishing this task. Their understanding of the potential for study groups has…

  8. Group theories: relevance to group safety studies.

    PubMed

    Benevento, A L

    1998-01-01

    Promoting safety in the workplace has been attempted in a variety of ways. Increasingly, industries are using groups such as safety teams and quality circles to promote worker safety. Group influences on individual behavior and attitudes have long been studied in the social psychology literature, but the theories have not been commonly found outside the psychology arena. This paper describes the group theories of group polarization, risky shift, social loafing, groupthink and team think and attempts to apply these theories to existing studies that examine work group influences on safety. Interesting parallels were found but only one study examined group influences as their primary focus of research. Since groups are increasingly used for safety promotion, future research on safety that studies group influences with respect to current group theories is recommended. PMID:24441299

  9. A Phase 2 Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy After Surgery in Patients With High-Risk Endometrial Cancer: A Korean Gynecologic Oncologic Group Study

    SciTech Connect

    Cho, Hanbyoul; Nam, Byung-Ho; Kim, Seok Mo; Cho, Chi-Heum; Kim, Byoung Gie; Ryu, Hee-Sug; Kang, Soon Beom; Kim, Jae-Hoon

    2014-09-01

    Purpose: A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer. Methods and Materials: Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m{sup 2} was administered once weekly for 5 weeks during radiation therapy. Results: Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. Conclusions: Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study.

  10. First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse

    PubMed Central

    2013-01-01

    Background Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness. Methods/Design The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. ‘Low educational qualifications’ is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment. The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services. Discussion This is the first study of the effectiveness of gFNP in the UK. Results should inform decision-making about its delivery alongside universal services, potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting. Trial registration ISRCTN78814904. PMID:24011061

  11. Results of a Quality Assurance Review of External Beam Radiation Therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: A SIOPEN Study

    SciTech Connect

    Gaze, Mark N.; Boterberg, Tom; Dieckmann, Karin; Hoermann, Marcus; Gains, Jennifer E.; Sullivan, Kevin P.; Ladenstein, Ruth

    2013-01-01

    Purpose: Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol. Methods and Materials: The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score. Results: It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting. Conclusions: Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.

  12. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    SciTech Connect

    Fairchild, Alysa; Straube, William; Laurie, Fran; Followill, David

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  13. Correlation functions from a unified variational principle: Trial Lie groups

    NASA Astrophysics Data System (ADS)

    Balian, R.; Vénéroni, M.

    2015-11-01

    Time-dependent expectation values and correlation functions for many-body quantum systems are evaluated by means of a unified variational principle. It optimizes a generating functional depending on sources associated with the observables of interest. It is built by imposing through Lagrange multipliers constraints that account for the initial state (at equilibrium or off equilibrium) and for the backward Heisenberg evolution of the observables. The trial objects are respectively akin to a density operator and to an operator involving the observables of interest and the sources. We work out here the case where trial spaces constitute Lie groups. This choice reduces the original degrees of freedom to those of the underlying Lie algebra, consisting of simple observables; the resulting objects are labeled by the indices of a basis of this algebra. Explicit results are obtained by expanding in powers of the sources. Zeroth and first orders provide thermodynamic quantities and expectation values in the form of mean-field approximations, with dynamical equations having a classical Lie-Poisson structure. At second order, the variational expression for two-time correlation functions separates-as does its exact counterpart-the approximate dynamics of the observables from the approximate correlations in the initial state. Two building blocks are involved: (i) a commutation matrix which stems from the structure constants of the Lie algebra; and (ii) the second-derivative matrix of a free-energy function. The diagonalization of both matrices, required for practical calculations, is worked out, in a way analogous to the standard RPA. The ensuing structure of the variational formulae is the same as for a system of non-interacting bosons (or of harmonic oscillators) plus, at non-zero temperature, classical Gaussian variables. This property is explained by mapping the original Lie algebra onto a simpler Lie algebra. The results, valid for any trial Lie group, fulfill consistency properties and encompass several special cases: linear responses, static and time-dependent fluctuations, zero- and high-temperature limits, static and dynamic stability of small deviations.

  14. Combined immunization of infants with oral and inactivated poliovirus vaccines: results of a randomized trial in The Gambia, Oman, and Thailand. WHO Collaborative Study Group on Oral and Inactivated Poliovirus Vaccines.

    PubMed Central

    1996-01-01

    To assess an immunization schedule combining oral (OPV) and inactivated poliovirus vaccines (IPV), we conducted a clinical trial in the Gambia, Oman, and Thailand. Children were randomized to receive one of the following schedules: OPV at birth, 6, 10, and 14 weeks of age; OPV at birth followed by both OPV and IPV at 6, 10, and 14 weeks of age: or placebo at birth followed by IPV at 6, 10, and 14 weeks of age. A total of 1685 infants were enrolled; 24-week serum specimens were available for 1291 infants (77%). Across the study sites at 24 weeks of age, the proportion of seropositive children in the combined schedule group was 95-99% for type 1, 99-100% for type 2, and 97-100% for type 3. In the Gambia and Oman, the combined schedule performed significantly better than OPV for type 1 (95-97% versus 88-90%) and type 3 (97-99% versus 72-73%). In the Gambia and Oman, seroprevalences in the IPV group were lower for type 1 (significantly lower in the Gambia); significantly lower for type 2; and significantly higher for type 3, compared with the OPV group. In Thailand, the IPV group had significantly lower proportions of children who were seropositive for each of the three types, compared with the OPV group. The responses to OPV in the Gambia, Oman, and Thailand were consistent with previous studies from these countries. IPV given at 6, 10, and 14 weeks of age provided inadequate serological protection against poliovirus, especially type 1. The combined schedule provided the highest levels of serum antibody response, with mucosal immunity equivalent to that produced by OPV alone. PMID:8789924

  15. Parental presence on neonatal intensive care unit clinical bedside rounds: randomised trial and focus group discussion

    PubMed Central

    Boswell, Danette; Broom, Margaret; Smith, Judith; Davis, Deborah

    2015-01-01

    Background There are limited data to inform the choice between parental presence at clinical bedside rounds (PPCBR) and non-PPCBR in neonatal intensive care units (NICUs). Methods We performed a single-centre, survey-based, crossed-over randomised trial involving parents of all infants who were admitted to NICU and anticipated to stay >11?days. Parents were randomly assigned using a computer-generated stratified block randomisation protocol to start with PPCBR or non-PPCBR and then crossed over to the other arm after a wash-out period. At the conclusion of each arm, parents completed the ‘NICU Parental Stressor Scale’ (a validated tool) and a satisfaction survey. After completion of the trial, we surveyed all healthcare providers who participated at least in one PPCBR rounding episode. We also offered all participating parents and healthcare providers the opportunity to partake in a focus group discussion regarding PPCBR. Results A total of 72 parents were enrolled in this study, with 63 parents (87%) partially or fully completing the trial. Of the parents who completed the trial, 95% agreed that parents should be allowed to attend clinical bedside rounds. A total of 39 healthcare providers’ surveys were returned and 35 (90%) agreed that parents should be allowed to attend rounds. Nine healthcare providers and 8 parents participated in an interview or focus group, augmenting our understanding of the ways in which PPCBR was beneficial. Conclusions Parents and healthcare providers strongly support PPCBR. NICUs should develop policies allowing PPCBR while mitigating the downsides and concerns of parents and healthcare providers such as decreased education opportunity and confidentiality concerns. Trial registration number Australia and New Zealand Clinical Trials Register number, ACTRN12612000506897. PMID:25711125

  16. Reconstructing Meaning with Others in Loss: A Feasibility Pilot Randomized Controlled Trial of a Bereavement Group.

    PubMed

    MacKinnon, Christopher J; Smith, Nathan Grant; Henry, Melissa; Milman, Evgenia; Chochinov, Harvey M; Körner, Annette; Berish, Mel; Farrace, Amanda Jessica; Liarikos, Nikoleta; Cohen, S Robin

    2015-08-01

    More effective psychosocial interventions that target uncomplicated bereavement are needed for those actively seeking support. The objective of this study was to assess the feasibility of evaluating a unique meaning-based group counseling (MBGC) intervention with a randomized controlled trial (RCT) design. Twenty-six bereft individuals were randomly assigned to either MBGC or a control bereavement support group. Twenty participants (11 experimental, nine control) completed all aspects of the study including self-report measures at baseline, postintervention, and 3-month follow-up of meaning in life, anxiety, depression, and grief. Results support the feasibility of an RCT with MBGC. PMID:25674830

  17. Insufficiency Fractures After Pelvic Radiation Therapy for Uterine Cervical Cancer: An Analysis of Subjects in a Prospective Multi-institutional Trial, and Cooperative Study of the Japan Radiation Oncology Group (JAROG) and Japanese Radiation Oncology Study Group (JROSG)

    SciTech Connect

    Tokumaru, Sunao; Toita, Takafumi; Oguchi, Masahiko; Ohno, Tatsuya; Kato, Shingo; Niibe, Yuzuru; Kazumoto, Tomoko; Kodaira, Takeshi; Kataoka, Masaaki; Shikama, Naoto; Kenjo, Masahiro; Yamauchi, Chikako; Suzuki, Osamu; Sakurai, Hideyuki; Teshima, Teruki; Kagami, Yoshikazu; Nakano, Takashi; Hiraoka, Masahiro; and others

    2012-10-01

    Purpose: To investigate pelvic insufficiency fractures (IF) after definitive pelvic radiation therapy for early-stage uterine cervical cancer, by analyzing subjects of a prospective, multi-institutional study. Materials and Methods: Between September 2004 and July 2007, 59 eligible patients were analyzed. The median age was 73 years (range, 37-84 years). The International Federation of Gynecologic Oncology and Obstetrics stages were Ib1 in 35, IIa in 12, and IIb in 12 patients. Patients were treated with the constant method, which consisted of whole-pelvic external-beam radiation therapy of 50 Gy/25 fractions and high-dose-rate intracavitary brachytherapy of 24 Gy/4 fractions without chemotherapy. After radiation therapy the patients were evaluated by both pelvic CT and pelvic MRI at 3, 6, 12, 18, and 24 months. Diagnosis of IF was made when the patients had both CT and MRI findings, neither recurrent tumor lesions nor traumatic histories. The CT findings of IF were defined as fracture lines or sclerotic linear changes in the bones, and MRI findings of IF were defined as signal intensity changes in the bones, both on T1- and T2-weighted images. Results: The median follow-up was 24 months. The 2-year pelvic IF cumulative occurrence rate was 36.9% (21 patients). Using Common Terminology Criteria for Adverse Events version 3.0, grade 1, 2, and 3 IF were seen in 12 (21%), 6 (10%), and 3 patients (5%), respectively. Sixteen patients had multiple fractures, so IF were identified at 44 sites. The pelvic IF were frequently seen at the sacroileal joints (32 sites, 72%). Nine patients complained of pain. All patients' pains were palliated by rest or non-narcotic analgesic drugs. Higher age (>70 years) and low body weight (<50 kg) were thought to be risk factors for pelvic IF (P=.007 and P=.013, Cox hazard test). Conclusions: Cervical cancer patients with higher age and low body weight may be at some risk for the development of pelvic IF after pelvic radiation therapy.

  18. Recruiting ethnic minority participants to a clinical trial: a qualitative study

    PubMed Central

    MacNeill, Virginia; Nwokoro, Chinedu; Griffiths, Chris; Grigg, Jonathan; Seale, Clive

    2013-01-01

    Objectives To compare the motives and experiences of different ethnic groups participating in a randomised double blind placebo-controlled trial of montelukast in preschool wheeze, and to assess parents’ or guardians’ understanding of trial procedures and their implications, including the collection of genetic material. Design Qualitative interviews with parents or guardians. Setting Interviews occurred in the homes of London children recruited to a national multicentre clinical trial following primary and secondary care attendance with wheeze. Participants 42 parents (20 of Bangladeshi origin, 10 white UK, 12 other ethnicities) of preschool children enrolled in a clinical trial. Results Bangladeshi families were relatively reluctant to participate in the qualitative study, despite strong engagement with the parent study. Anxiety related to wheezing was a common primary motive for trial enrolment. Parents viewed the trial as a route to improved treatment. Verbal delivery of trial information appeared more effective than study literature, especially for Bangladeshi families, with low parental literacy and high levels of trust in medical professionals potential contributors to this effect. All ethnic groups expressed a low understanding and/or retention of essential study concepts such as randomisation and genetic testing. Conclusions Bangladeshi families are particularly motivated to participate in clinical trials despite variable comprehension of study concepts. This motivation is more strongly contingent on strong researcher-subject rapport than on the quality of study literature. Trial teams seeking to recruit from South Asian populations should emphasise face-to-face verbal explanation of trial concepts and procedures and consider modified trial literature. PMID:23572193

  19. HIV-1 RNA Levels and Antiretroviral Drug Resistance in Blood and Non-Blood Compartments from HIV-1–Infected Men and Women enrolled in AIDS Clinical Trials Group Study A5077

    PubMed Central

    Kantor, Rami; Bettendorf, Daniel; Bosch, Ronald J.; Mann, Marita; Katzenstein, David; Cu-Uvin, Susan; D’Aquila, Richard; Frenkel, Lisa; Fiscus, Susan; Coombs, Robert

    2014-01-01

    Background Detectable HIV-1 in body compartments can lead to transmission and antiretroviral resistance. Although sex differences in viral shedding have been demonstrated, mechanisms and magnitude are unclear. We compared RNA levels in blood, genital-secretions and saliva; and drug resistance in plasma and genital-secretions of men and women starting/changing antiretroviral therapy (ART) in the AIDS Clinical Trials Group (ACTG) 5077 study. Methods Blood, saliva and genital-secretions (compartment fluids) were collected from HIV-infected adults (?13 years) at 14 United-States sites, who were initiating or changing ART with plasma viral load (VL) ?2,000 copies/mL. VL testing was performed on all compartment fluids and HIV resistance genotyping on plasma and genital-secretions. Spearman rank correlations were used to evaluate concordance and Fisher’s and McNemar’s exact tests to compare VL between sexes and among compartments. Results Samples were available for 143 subjects; 36% treated (23 men, 29 women) and 64% ‘untreated’ (40 men, 51 women). RNA detection was significantly more frequent in plasma (100%) than genital-secretions (57%) and saliva (64%) (P<0.001). A higher proportion of men had genital shedding versus women (78% versus 41%), and RNA detection was more frequent in saliva versus genital-secretions in women when adjusted for censoring at the limit of assay detection. Inter-compartment fluid VL concordance was low in both sexes. In 22 (13 men, 9 women) paired plasma-genital-secretion genotypes from treated subjects, most had detectable resistance in both plasma (77%) and genital-secretions (68%). Resistance discordance was observed between compartments in 14% of subjects. Conclusions HIV shedding and drug resistance detection prior to initiation/change of ART in ACTG 5077 subjects differed among tissues and between sexes, making the gold standard blood-plasma compartment assessment not fully representative of HIV at other tissue sites. Mechanisms of potential sex-dependent tissue compartmentalization should be further characterized to aid in optimizing treatment and prevention of HIV transmission. Trial Registration ClinicalTrials.gov NCT00007488 PMID:24699474

  20. A randomized controlled trial of larval therapy for the debridement of leg ulcers: results of a multicenter, randomized, controlled, open, observer blind, parallel group study.

    PubMed

    Mudge, Elizabeth; Price, Patricia; Walkley, Neal; Neal, Walkley; Harding, Keith G

    2014-01-01

    It has been known for centuries that the application of larvae is useful to heal certain wounds by facilitating debridement of necrotic tissue,(1) yet the efficacy of larval therapy continues to be debatable. This study compared the clinical effectiveness of a larval therapy dressing (BioFOAM) with a standard debridement technique (Purilon gel; hydrogel) in terms of time to debridement of venous (VLU) or mixed arterial/venous (MLU) leg ulcers. Data analyses were conducted on 88 subjects. Sixty-four subjects completed the full study. Of these, 31 of the 32 (96.9%) patients who completed treatment in the larvae arm debrided fully, compared with 11 of the 32 (34.4%) patients who completed the hydrogel arm. In addition, 42 (48%) ulcers fully debrided within the 21-day intervention phase, 31 (67.4%) from the larvae arm (n?=?46), and 11 (26.2%) from the hydrogel arm (n?=?42), which was statistically significant (p?=?0.001) in support of larvae. A statistically significant difference was also observed between treatment arms with regard to numbers of dressing changes during the intervention phase of the study (p?study provided good evidence to show that larval therapy, in the form of a BioFOAM dressing, debrided VLU and MLU considerably more quickly than a hydrogel, although the possibility of resloughing should be closely monitored. PMID:24299513

  1. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Cancer.gov

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting.

  2. Quality Assessment for Therapeutic Drug Monitoring in AIDS Clinical Trials Group (ACTG 5146): A Multicenter Clinical Trial

    PubMed Central

    DiFrancesco, Robin; Rosenkranz, Susan; Mukherjee, A. Lisa; Demeter, Lisa M.; Jiang, Hongyu; DiCenzo, Robert; Dykes, Carrie; Rinehart, Alex; Albrecht, Mary; Morse, Gene D.

    2010-01-01

    In a randomized trial, AIDS Clinical Trials Group (ACTG) protocol 5146 (A5146) investigated the use of TDM to adjust doses of HIV-1 protease inhibitors (PIs) in patients with prior virologic failure on PI-based therapy who were starting a new PI-based regimen. The overall percentage of “PI trough repeats”, such as rescheduled visits or redrawn PI trough specimens, increased from 2% to 5% to 10% as the process progressed from the clinical sites, the PSL, and the study team, respectively. Cumulatively, this represents a 17% rate of failure to obtain adequate PI trough sample. While targeting a turn-around of ? 7 days from sample receipt to a drug concentration report, 12% of the received specimens required a longer period to report concentrations. The implementation of dosing changes in the TDM arm were achieved within ?7 days for 56% of the dose change events, and within ?14 days for 77% of dose change events. This quality assurance analysis provides a valuable summary of the specific points in the TDM process that could be improved during a multicenter clinical trial including: [1] shortening the timeline of sample shipment from clinical site to the lab, [2] performing the collection of PI trough specimen within the targeted sampling window by careful monitoring of the last dose times and collection times by the clinicians [3] increasing patient adherence counseling to reduce the number of samples that are redrawn due to suspecting inconsistent adherence, and [4] decreasing the time to successful TDM-based dose adjustment. The application of some of these findings may also be relevant to single center studies or clinical TDM programs within a hospital. PMID:20592644

  3. A Phase 1 Trial of Imetelstat in Children with Refractory or Recurrent Solid Tumors: A Children’s Oncology Group Phase 1 Consortium Study (ADVL1112)

    PubMed Central

    Thompson, Patrick A.; Drissi, Rachid; Muscal, Jodi A.; Panditharatna, Eshini; Fouladi, Maryam; Ingle, Ashish M.; Ahern, Charlotte H.; Reid, Joel M.; Lin, Tong; Weigel, Brenda J.; Blaney, Susan M.

    2014-01-01

    Purpose Imetelstat is a covalently-lipidated 13-mer thiophosphoramidate oligonucleotide that acts as a potent specific inhibitor of telomerase. It binds with high affinity to the template region of the RNA component of human telomerase (hTERC ) and is a competitive inhibitor of telomerase enzymatic activity. The purpose of this study was to determine the recommended phase 2 dose of imetelstat in children with recurrent or refractory solid tumors. Experimental Design Imetelstat was administered intravenously over two hours on days 1 and 8, every 21 days. Dose levels of 225, 285, and 360 mg/m2 were evaluated, using the rolling-six design. Imetelstat pharmacokinetic and correlative biology studies were also performed during the first cycle. Results Twenty subjects were enrolled (median age 14 yrs; range 3–21). Seventeen were evaluable for toxicity. The most common toxicities were neutropenia, thrombocytopenia, and lymphopenia, with dose-limiting myelosuppression in two of six patients at 360 mg/m2. Pharmacokinetics were dose dependent with a lower clearance at the highest dose level. Telomerase inhibition was observed in peripheral blood mononuclear cells at 285 and 360 mg/m2. Two confirmed partial responses osteosarcoma (n=1) and Ewing sarcoma (n=1) were observed. Conclusions The recommended phase 2 dose of imetelstat given on days 1 and 8 of 21-day cycle is 285 mg/m2. PMID:24097866

  4. Effect of Education through Support ­Group on Early Symptoms of Menopause: a Randomized Controlled Trial

    PubMed Central

    Sehhatie Shafaie, Fahimeh; Mirghafourvand, Mozhgan; Jafari, Maryam

    2014-01-01

    Introduction: Menopause is one of the most important crises in the life of women. The control of menopause symptoms is a main challenge in providing care to this population. So, the aim of present study was to investigate the effect of education through support ­group on early symptoms of menopause. Methods: In this randomized controlled clinical trial 124 postmenopausal women who had a health records in Valiasr participatory health center of Eslamshahr city were participated. These women were allocated by block randomization method into support group (62 women) and control group (62 women).Women in support group was assigned into 6 groups. Three 60-minutes educational sessions were conducted in 3 sequential weekly sessions. Early menopausal symptoms were measured before and 4 weeks after the intervention by using Greene scale (score ranged from 0 to 63). Data analysis was performed by ANCOVA statistical test. Results: There were no statistical differences between two groups in demographic characteristics and the total score of the Greene scale before intervention. The mean score of the Greene scale in support group was statistically less than control group 4 weeks after intervention. The number of hot flashes in the support group was significantly lower than control group, 4 weeks after intervention.Conclusion: Education through support group was effective in reducing the early symptoms of menopause. Thus, this educational method can be used as an appropriate strategy for enhancing women’ health and their dealing with annoying symptoms of menopause. PMID:25709980

  5. Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12-93.

    PubMed

    Pagani, Olivia; Gelber, Shari; Simoncini, Edda; Castiglione-Gertsch, Monica; Price, Karen N; Gelber, Richard D; Holmberg, Stig B; Crivellari, Diana; Collins, John; Lindtner, Jurij; Thürlimann, Beat; Fey, Martin F; Murray, Elizabeth; Forbes, John F; Coates, Alan S; Goldhirsch, Aron

    2009-08-01

    To compare the efficacy of chemoendocrine treatment with that of endocrine treatment (ET) alone for postmenopausal women with highly endocrine responsive breast cancer. In the International Breast Cancer Study Group (IBCSG) Trials VII and 12-93, postmenopausal women with node-positive, estrogen receptor (ER)-positive or ER-negative, operable breast cancer were randomized to receive either chemotherapy or endocrine therapy or combined chemoendocrine treatment. Results were analyzed overall in the cohort of 893 patients with endocrine-responsive disease, and according to prospectively defined categories of ER, age and nodal status. STEPP analyses assessed chemotherapy effect. The median follow-up was 13 years. Adding chemotherapy reduced the relative risk of a disease-free survival event by 19% (P = 0.02) compared with ET alone. STEPP analyses showed little effect of chemotherapy for tumors with high levels of ER expression (P = 0.07), or for the cohort with one positive node (P = 0.03). Chemotherapy significantly improves disease-free survival for postmenopausal women with endocrine-responsive breast cancer, but the magnitude of the effect is substantially attenuated if ER levels are high. PMID:18953651

  6. Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer

    PubMed Central

    Karlsson, P.; Sun, Z.; Braun, D.; Price, K. N.; Castiglione-Gertsch, M.; Rabaglio, M.; Gelber, R. D.; Crivellari, D.; Collins, J.; Murray, E.; Zaman, K.; Colleoni, M.; Gusterson, B. A.; Viale, G.; Regan, M. M.; Coates, A. S.; Goldhirsch, A.

    2011-01-01

    Background: The International Breast Cancer Study Group Trial VIII compared long-term efficacy of endocrine therapy (goserelin), chemotherapy [cyclophosphamide, methotrexate and fluorouracil (CMF)], and chemoendocrine therapy (CMF followed by goserelin) for pre/perimenopausal women with lymph-node-negative breast cancer. Patients and methods: From 1990 to 1999, 1063 patients were randomized to receive (i) goserelin for 24 months (n = 346), (ii) six courses of ‘classical’ CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy (n = 360), or (iii) six courses of CMF plus 18 months goserelin (CMF? goserelin; n = 357). Tumors were classified as estrogen receptor (ER) negative (19%), ER positive (80%), or ER unknown (1%); 19% of patients were younger than 40. Median follow-up was 12.1 years. Results: For the ER-positive cohort, sequential therapy provided a statistically significant benefit in disease-free survival (DFS) (12-year DFS = 77%) compared with CMF alone (69%) and goserelin alone (68%) (P = 0.04 for each comparison), due largely to the effect in younger patients. Patients with ER-negative tumors whose treatment included CMF had similar DFS (12-year DFS CMF = 67%; 12-year DFS CMF? goserelin = 69%) compared with goserelin alone (12-year DFS = 61%, P= NS). Conclusions: For pre/perimenopausal women with lymph-node-negative ER-positive breast cancer, CMF followed by goserelin improved DFS in comparison with either modality alone. The improvement was the most pronounced in those aged below 40, suggesting an endocrine effect of prolonged CMF-induced amenorrhea. PMID:21325445

  7. Study Groups: Conduit for Reform.

    ERIC Educational Resources Information Center

    Makibbin, Shirley S.; Sprague, Marsha M.

    This conference presentation describes study groups as a mechanism for changing teacher behavior. The history of study groups is discussed, beginning with the first American study groups organized by Benjamin Franklin; the Chautauqua Literary and Scientific Circle; the waning of study groups in the early 20th century as college enrollment…

  8. Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Pancreatic ductal adenocarcinoma (PDA) is one of the most aggressive malignancies with marked resistance to chemo- and radiotherapy. PDA-cancer stem cells (CSCs) are not targeted by current therapies and may be a reason for poor prognosis. Studies indicate that diets rich in cabbage, broccoli, and cauliflower offer cancer preventative and therapeutic benefits. Recent experimental studies have confirmed these findings and demonstrated that isothiocyanate, sulforaphane, and the polyphenol, quercetin, effectively reduced tumor growth and enhanced the sensitivity of the cancer cells to current chemotherapeutics. The aim of the present study is to test the feasibility of a randomized controlled trial on the application of freeze-dried broccoli sprouts in patients with advanced PDA. Methods and study design The study is designed as a prospective randomized, double-blinded pilot trial with a treatment and a placebo-controlled arm in a single center setting. A total number of forty patients (18 years or older) in two parallel groups with advanced, surgically non-resectable PDA under palliative chemotherapy are planned for recruitment. Patients in the treatment group will receive fifteen capsules of the study substance per day (90 mg of active sulforaphane) during the chemotherapy treatment course. Patients in the placebo group will receive the same capsule size and portion distribution with inactive substances (mainly methylcellulose). The follow-up duration is one year. Feasibility of the study substance, adverse effects, and patient compliance, as well as levels of serum tumor markers (CEA, CA 19-9), quality of life, and patient overall survival rates will be assessed at defined points of time. Discussion The POUDER trial is expected to transfer promising experimental and epidemiological data into a clinical pilot study to assess the effectiveness of broccoli sprout extracts in the treatment of advanced PDA. The study objectives will provide data on the clinical feasibility and acceptability of a supportive treatment option accompanying palliative chemotherapy. Based on these results, future clinical studies to create further evidence in this field are possible. Trial registration The POUDER trial has been registered at ClinicalTrials.gov with an ID NCT01879878 and WHO with an ID U1111-1144-2013 on June 13th 2013. PMID:24894410

  9. Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

    PubMed Central

    2013-01-01

    Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase. Discussion The DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression. The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505). Trial registration Current controlled trials ISRCTN89333241. PMID:23915015

  10. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial

    PubMed Central

    Williams, Alishia D; Blackwell, Simon E; Holmes, Emily A; Andrews, Gavin

    2013-01-01

    Introduction The current randomised controlled trial will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification (CBM) intervention for depression when compared with an active control condition and help establish the additive benefit of positive imagery CBM when delivered in combination with internet cognitive behavioural therapy for depression. Methods and analysis Patients meeting diagnostic criteria for a current major depressive episode will be recruited through the research arm of a not-for-profit clinical and research unit in Australia. The minimum sample size for each group (? set at 0.05, power at 0.80) was identified as 29, but at least 10% more will be recruited to hedge against expected attrition. We will measure the impact of CBM on primary measures of depressive symptoms (Beck Depression Inventory—second edition (BDI-II), Patient Health Questionnaire (PHQ9)) and interpretive bias (ambiguous scenarios test-depression), and on a secondary measure of psychological distress (Kessler-10 (K10)) following the 1-week CBM intervention. Secondary outcome measures of psychological distress (K10), as well as disability (WHO disability assessment schedule-II), repetitive negative thinking (repetitive thinking questionnaire), and anxiety (state trait anxiety inventory-trait version) will be evaluated following completion of the 11-week combined intervention, in addition to the BDI-II and PHQ9. Intent-to-treat marginal and mixed effect models using restricted maximum likelihood estimation will be used to evaluate the primary hypotheses. Clinically significant change will be defined as high-end state functioning (a BDI-II score <14) combined with a total score reduction greater than the reliable change index score. Maintenance of gains will be assessed at 3-month follow-up. Ethics and dissemination The current trial protocol has been approved by the Human Research Ethics Committee of St Vincent's Hospital and the University of New South Wales, Sydney. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12613000139774 and Clinicaltrials.gov: NCT01787513. This trial protocol is written in compliance with the Standard Protocol Items: recommendations for Interventional Trials (SPIRIT) guidelines. PMID:24171941

  11. Randomization Inference in a GroupRandomized Trial of Treatments for Depression: Covariate

    E-print Network

    Small, Dylan

    Randomization Inference in a Group­Randomized Trial of Treatments for Depression: Covariate a "depression care manager" to treat its depressed patients. Randomization inference, properly performed individual patients: depression outcomes, baseline covariates, compliance with treatment. The methods

  12. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    PubMed Central

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. Methods/Design The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. Discussion The results of the trial will be used to produce a maximally effective sexual assault resistance education program that can be adopted by universities, to assess whether aspects of the program need to be strengthened, and also to indicate how long the effects of the program last and at which point in time refresher sessions may be necessary. Trial registration ClinicalTrials.gov NCT01338428 PMID:23702221

  13. Marketing and clinical trials: a case study

    E-print Network

    Francis, David; Roberts, Ian; Elbourne, Diana; Shakur, Haleema K.; Knight, Rosemary C.; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A.; McDonald, Alison M.; Grant, Adrian M.; Campbell, Marion K.

    2007-11-20

    Research Marketing and clinical trials: a case study David Francis*1, Ian Roberts2, Diana R Elbourne3, Haleema Shakur2, Rosemary C Knight3, Jo Garcia3, Claire Snowdon3,4, Vikki A Entwistle5, Alison M McDonald5, Adrian M Grant5 and Marion K Campbell5 Address: 1... Email: David Francis* - dlf@brighton.ac.uk; Ian Roberts - Ian.Roberts@lshtm.ac.uk; Diana R Elbourne - diana.elbourne@lshtm.ac.uk; Haleema Shakur - Haleema.shakur@lshtm.ac.uk; Rosemary C Knight - Rosemary.Knight@lshtm.ac.uk; Jo Garcia - j...

  14. Phase 1 trial of gemtuzumab ozogamicin in combination with enocitabine and daunorubicin for elderly patients with relapsed or refractory acute myeloid leukemia: Japan Adult Leukemia Study Group (JALSG)-GML208 study.

    PubMed

    Ito, Yoshikazu; Wakita, Atsushi; Takada, Satoru; Mihara, Masahiro; Gotoh, Moritaka; Ohyashiki, Kazuma; Ohtake, Shigeki; Miyawaki, Shuichi; Ohnishi, Kazunori; Naoe, Tomoki

    2012-10-01

    We conducted a phase 1 study of a combination of gemtuzumab ozogamicin (GO) plus conventional chemotherapy in elderly patients (? 65 years old) with relapsed or refractory CD33-positive acute myeloid leukemia (AML). Patients received a standard dose of enocitabine (200 mg/m² × 8 days) and daunorubicin (30 mg/m² × days 1-3) plus an escalating dose of GO (1.5-5 mg/m² on day 4). The dose escalation of GO was done according to a standard 3 + 3 design following a modified Fibonacci sequence. No dose-limiting toxicities were observed in three patients (median age, 71) at level 1 (1.5 mg/m²) or in three patients (median age, 73) at level 2 (3 mg/m²). Neither veno-occlusive diseases nor sinusoidal obstructive syndromes were noted at either level. However, as GO was withdrawn from the US market in June 2010, based on a randomized study in newly diagnosed AML, we decided not to proceed to the level 3 (5 mg/m²) in order to avoid possibly more severe adverse effects, and also because all six patients experienced grade 4 myelosuppression, with complete remission in three. This study showed that 3 mg/m² of GO in combination with enocitabine and daunorubicin may be a recommendable dose for a phase 2 study in Japanese elderly patients with CD33-positive AML. The study was registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ ) as UMIN000002603. PMID:22956429

  15. The transitioning from trials to extended follow-up studies

    PubMed Central

    Drye, Lea T.; Casper, Anne S.; Sternberg, Alice L.; Holbrook, Janet T.; Jenkins, Gabrielle; Meinert, Curtis L.

    2014-01-01

    Background Investigators may elect to extend follow-up of participants enrolled in a randomized clinical trial after the trial comes to its planned end. The additional follow-up may be initiated to learn about longer term effects of treatments including adverse events, costs related to treatment, or for reasons unrelated to treatment such as to observe the natural course of the disease using the established cohort from the trial. Purpose We examine transitioning from trials to extended follow-up studies when the goal of additional follow-up is to observe longer term treatment effects. Methods We conducted a literature search in selected journals from 2000–2012 to identify trials that extended follow-up for the purpose of studying longer term treatment effects and extracted information on the operational and logistical issues in the transition. We also draw experience from three trials coordinated by the Johns Hopkins Coordinating Centers that made transitions to extended followup: the Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT); Multicenter Uveitis Steroid Treatment (MUST) trial; and Childhood Asthma Management Program (CAMP). Results Transitions are not uncommon in multicenter clinical trials, even in trials that continued to the planned end of the trial. Transitioning usually necessitates new participant consents. If study infrastructure is not maintained during the transition, participants will be lost and re-establishing the staff and facilities will be costly. Merging data from the trial and follow-up study can be complicated by changes in data collection measures and schedules. Limitations Our discussion and recommendations are limited to issues that we have experienced in transitions from trials to follow-up studies. Discussion We discuss issues such as maintaining funding, IRB and consent requirements, contacting participants, and combining data from the trial and follow-up phases. We conclude with a list of recommendations to facilitate transitions from a trial to an extended follow-up study. PMID:25115882

  16. p-adic Groups Seminar / Study group

    E-print Network

    Carbone, Lisa

    , and accounts of it have been written by Tits and Satake. Tits compiled tables of `admissible indices' from which groups can be constructed. We describe Tits' tables for groups of relative rank 1 over non in pure and applied mathematics ; v. 3. [Ti1] Tits, J, Reductive groups over local fields, Automorphic

  17. Group cognitive behavioural therapy and group recreational activity for adults with autism spectrum disorders: A preliminary randomized controlled trial

    PubMed Central

    Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This preliminary randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive behavioural therapy and recreational activity. Both interventions comprised 36 weekly 3-h sessions led by two therapists in groups of 6–8 patients. A total of 68 psychiatric patients with autism spectrum disorders participated in the study. Outcome measures were Quality of Life Inventory, Sense of Coherence Scale, Rosenberg Self-Esteem Scale and an exploratory analysis on measures of psychiatric health. Participants in both treatment conditions reported an increased quality of life at post-treatment (d = 0.39, p < 0.001), with no difference between interventions. No amelioration of psychiatric symptoms was observed. The dropout rate was lower with cognitive behavioural therapy than with recreational activity, and participants in cognitive behavioural therapy rated themselves as more generally improved, as well as more improved regarding expression of needs and understanding of difficulties. Both interventions appear to be promising treatment options for adults with autism spectrum disorder. The interventions’ similar efficacy may be due to the common elements, structure and group setting. Cognitive behavioural therapy may be additionally beneficial in terms of increasing specific skills and minimizing dropout. PMID:24089423

  18. Placebo-Controlled Trial to Determine the Effectiveness of a Urea/Lactic Acid–Based Topical Keratolytic Agent for Prevention of Capecitabine-Induced Hand-Foot Syndrome: North Central Cancer Treatment Group Study N05C5

    PubMed Central

    Wolf, Sherry L.; Qin, Rui; Menon, Smitha P.; Rowland, Kendrith M.; Thomas, Sachdev; Delaune, Robert; Christian, Diana; Pajon, Eduardo R.; Satele, Daniel V.; Berenberg, Jeffrey L.; Loprinzi, Charles L.

    2010-01-01

    Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical keratolytic agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of patients with moderate/severe HFS symptoms was not different between groups, being 13.6% in the ULABTKA arm and 10.2% in the placebo arm (P = .768 by Fisher's exact test). The odds ratio was 1.37 (95% CI, 0.37 to 5.76). Cycle 1 CTCAE skin toxicity was higher in the ULABTKA arm but not significantly so (33% v 27%; P = .82). No significant differences were observed in other toxicities between groups. Conclusion These data do not support the efficacy of a ULABTKA cream for preventing HFS symptoms in patients receiving capecitabine. PMID:21060036

  19. The National Lung Screening Trial: overview and study design.

    PubMed

    Aberle, Denise R; Berg, Christine D; Black, William C; Church, Timothy R; Fagerstrom, Richard M; Galen, Barbara; Gareen, Ilana F; Gatsonis, Constantine; Goldin, Jonathan; Gohagan, John K; Hillman, Bruce; Jaffe, Carl; Kramer, Barnett S; Lynch, David; Marcus, Pamela M; Schnall, Mitchell; Sullivan, Daniel C; Sullivan, Dorothy; Zylak, Carl J

    2011-01-01

    The National Lung Screening Trial (NLST) is a randomized multicenter study comparing low-dose helical computed tomography (CT) with chest radiography in the screening of older current and former heavy smokers for early detection of lung cancer, which is the leading cause of cancer-related death in the United States. Five-year survival rates approach 70% with surgical resection of stage IA disease; however, more than 75% of individuals have incurable locally advanced or metastatic disease, the latter having a 5-year survival of less than 5%. It is plausible that treatment should be more effective and the likelihood of death decreased if asymptomatic lung cancer is detected through screening early enough in its preclinical phase. For these reasons, there is intense interest and intuitive appeal in lung cancer screening with low-dose CT. The use of survival as the determinant of screening effectiveness is, however, confounded by the well-described biases of lead time, length, and overdiagnosis. Despite previous attempts, no test has been shown to reduce lung cancer mortality, an endpoint that circumvents screening biases and provides a definitive measure of benefit when assessed in a randomized controlled trial that enables comparison of mortality rates between screened individuals and a control group that does not undergo the screening intervention of interest. The NLST is such a trial. The rationale for and design of the NLST are presented. PMID:21045183

  20. Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

    2014-01-01

    Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

  1. The Effectiveness of a Group Triple P with Chinese Parents Who Have a Child with Developmental Disabilities: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Leung, Cynthia; Fan, Angel; Sanders, Matthew R.

    2013-01-01

    The study examined the effectiveness of Group Triple P, a Level 4 variant of the Triple P multilevel system of parenting support, with Chinese parents who had a preschool aged child with a developmental disability, using randomized controlled trial design. Participants (Intervention group: 42; Waitlist Control group: 39) completed measures on…

  2. Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial. | accrualnet.cancer.gov

    Cancer.gov

    Some patients assigned to clinical trial control groups are disappointed at not participating in the intervention group. This disappointment is often given as the reason patients withdraw from trials. In this study, patients who said they were very disappointed also said that they had not received understandable information provided during the consent process. The authors provide suggestions for addressing patients’ needs to lower drop-out rates. It is especially important to make sure that patients understand randomization prior to enrollment.

  3. Empirical Bayes for Group (DCM) Studies: A Reproducibility Study

    PubMed Central

    Litvak, Vladimir; Garrido, Marta; Zeidman, Peter; Friston, Karl

    2015-01-01

    This technical note addresses some key reproducibility issues in the dynamic causal modelling of group studies of event related potentials. Specifically, we address the reproducibility of Bayesian model comparison (and inferences about model parameters) from three important perspectives namely: (i) reproducibility with independent data (obtained by averaging over odd and even trials); (ii) reproducibility over formally distinct models (namely, classic ERP and canonical microcircuit or CMC models); and (iii) reproducibility over inversion schemes (inversion of the grand average and estimation of group effects using empirical Bayes). Our hope was to illustrate the degree of reproducibility one can expect from DCM when analysing different data, under different models with different analyses.

  4. Empirical Bayes for Group (DCM) Studies: A Reproducibility Study.

    PubMed

    Litvak, Vladimir; Garrido, Marta; Zeidman, Peter; Friston, Karl

    2015-01-01

    This technical note addresses some key reproducibility issues in the dynamic causal modelling of group studies of event related potentials. Specifically, we address the reproducibility of Bayesian model comparison (and inferences about model parameters) from three important perspectives namely: (i) reproducibility with independent data (obtained by averaging over odd and even trials); (ii) reproducibility over formally distinct models (namely, classic ERP and canonical microcircuit or CMC models); and (iii) reproducibility over inversion schemes (inversion of the grand average and estimation of group effects using empirical Bayes). Our hope was to illustrate the degree of reproducibility one can expect from DCM when analysing different data, under different models with different analyses. PMID:26733846

  5. The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update.

    PubMed

    Smith, Norm D; Castle, Erik P; Gonzalgo, Mark L; Svatek, Robert S; Weizer, Alon Z; Montgomery, Jeffrey S; Pruthi, Raj S; Woods, Michael E; Tollefson, Matthew K; Konety, Badrinath R; Shabsigh, Ahmad; Krupski, Tracey; Barocas, Daniel A; Dash, Atreya; Quek, Marcus L; Kibel, Adam S; Parekh, Dipen J

    2015-02-01

    The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1-T4, N0-N1, M0 bladder cancer with ?160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1-T4, N0-N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016-2017. PMID:25626182

  6. Multicomponent Interdisciplinary Group Intervention for Self-Management of Fibromyalgia: A Mixed-Methods Randomized Controlled Trial

    PubMed Central

    Bourgault, Patricia; Lacasse, Anaïs; Marchand, Serge; Courtemanche-Harel, Roxanne; Charest, Jacques; Gaumond, Isabelle; Barcellos de Souza, Juliana; Choinière, Manon

    2015-01-01

    Background This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS. Methods A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients. Results The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ?50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures. Conclusion The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients’ experience. Trial registration International Standard Randomized Controlled Trial Number Register ISRCTN14526380 PMID:25978402

  7. Bicultural resynthesis: Tailoring an effectiveness trial for a group of urban American Indian women.

    PubMed

    Napholz, L

    2000-01-01

    The purpose of this qualitative study of a 6-week effectiveness trial was to describe among a group of urban American Indian women, the process of successful traditionalism in the form of bicultural resynthesis. Bicultural resynthesis represents a major current attempt on the part of the participants to integrate traditional and contemporary demands in a positive, culturally-consistent manner. The themes of shame and isolation, adapting to survive, deculturation, ethnic switching/renewal, and bicultural resynthesis are discussed. Further support is achieved for retraditionalization of American Indian women s roles as an effective means of achieving American Indian self-determination and as a potential way of helping women overcome problems. PMID:11279562

  8. Experimental and trial-based study of Resilient Packet Ring

    NASA Astrophysics Data System (ADS)

    Ramnath, Vasudha; Cheng, Heng Seng; Ngoh, Lek Heng

    2002-08-01

    An experimental study of the Resilient Packet Ring (RPR) media access control (MAC) technology that is optimized for IP traffic in the metropolitan-area-network (MAN) environment is described. The study involved the deployment and trials of a RPR testbed encompassing a public optical fiber infrastructure in which Cisco Systems' Dynamic Packet Transport (DPT) Ring Technology - a prestandard RPR implementation - was used. We focus on a number of important RPR protocol features that are vital to the future success of RPR as a MAN/wide-area-network (WAN) network technology. Related research on RPR/DPT has been done so far through simulation studies only. Standardization of RPR is currently being performed by the Institute of Electrical and Electronics Engineers (IEEE) 802.17 working group and is expected to be completed in 2003. Also, we present and discuss the experiments and tests performed to investigate the key features of RPR, along with the results obtained.

  9. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n?=?5) (200 mg twice daily for four weeks) or placebo group (n?=?5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  10. An Investigation of the Shortcomings of the CONSORT 2010 Statement for the Reporting of Group Sequential Randomised Controlled Trials: A Methodological Systematic Review

    PubMed Central

    Stevely, Abigail; Dimairo, Munyaradzi; Todd, Susan; Julious, Steven A.; Nicholl, Jonathan; Hind, Daniel; Cooper, Cindy L.

    2015-01-01

    Background It can be argued that adaptive designs are underused in clinical research. We have explored concerns related to inadequate reporting of such trials, which may influence their uptake. Through a careful examination of the literature, we evaluated the standards of reporting of group sequential (GS) randomised controlled trials, one form of a confirmatory adaptive design. Methods We undertook a systematic review, by searching Ovid MEDLINE from the 1st January 2001 to 23rd September 2014, supplemented with trials from an audit study. We included parallel group, confirmatory, GS trials that were prospectively designed using a Frequentist approach. Eligible trials were examined for compliance in their reporting against the CONSORT 2010 checklist. In addition, as part of our evaluation, we developed a supplementary checklist to explicitly capture group sequential specific reporting aspects, and investigated how these are currently being reported. Results Of the 284 screened trials, 68(24%) were eligible. Most trials were published in “high impact” peer-reviewed journals. Examination of trials established that 46(68%) were stopped early, predominantly either for futility or efficacy. Suboptimal reporting compliance was found in general items relating to: access to full trials protocols; methods to generate randomisation list(s); details of randomisation concealment, and its implementation. Benchmarking against the supplementary checklist, GS aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Moreover, 52(76%) trials failed to disclose methods used to minimise the risk of operational bias, due to the knowledge or leakage of interim results. Occurrence of changes to trial methods and outcomes could not be determined in most trials, due to inaccessible protocols and amendments. Discussion and Conclusions There are issues with the reporting of GS trials, particularly those specific to the conduct of interim analyses. Suboptimal reporting of bias correction methods could potentially imply most GS trials stopping early are giving biased results of treatment effects. As a result, research consumers may question credibility of findings to change practice when trials are stopped early. These issues could be alleviated through a CONSORT extension. Assurance of scientific rigour through transparent adequate reporting is paramount to the credibility of findings from adaptive trials. Our systematic literature search was restricted to one database due to resource constraints. PMID:26528812

  11. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  12. Phase III Study of Radiation Therapy With or Without Cis-Platinum in Patients With Unresectable Squamous or Undifferentiated Carcinoma of the Head and Neck: An Intergroup Trial of the Eastern Cooperative Oncology Group (E2382)

    SciTech Connect

    Quon, Harry; Leong, Traci; Haselow, Robert; Leipzig, Bruce; Cooper, Jay; Forastiere, Arlene

    2011-11-01

    Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m{sup 2}. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m{sup 2} to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

  13. What to Do when Data Are Missing in Group Randomized Controlled Trials. NCEE 2009-0049

    ERIC Educational Resources Information Center

    Puma, Michael J.; Olsen, Robert B.; Bell, Stephen H.; Price, Cristofer

    2009-01-01

    This NCEE Technical Methods report examines how to address the problem of missing data in the analysis of data in Randomized Controlled Trials (RCTs) of educational interventions, with a particular focus on the common educational situation in which groups of students such as entire classrooms or schools are randomized. Missing outcome data are a…

  14. "Right from the Start": Randomized Trial Comparing an Attachment Group Intervention to Supportive Home Visiting

    ERIC Educational Resources Information Center

    Niccols, Alison

    2008-01-01

    Background: Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security. Methods: In a randomized trial involving 76 mothers, an 8-session…

  15. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening.

    PubMed

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-03-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals. PMID:25635703

  16. Attitudes of primary care physicians toward cancer-prevention trials: a focus group analysis.

    PubMed Central

    Frayne, S. M.; Mancuso, M.; Prout, M. N.; Freund, K. M.

    2001-01-01

    PURPOSE: Recruitment of low-income and minority women to cancer-prevention trials requires a joint effort from specialists and primary care providers. We sought to assess primary care providers' attitudes toward participating in cancer-prevention trial recruitment. PROCEDURES: We conducted a focus group with seven Boston-based primary care providers serving low-income and minority women. Providers discussed knowledge, attitudes, and beliefs regarding their role in recruitment to prevention trials. FINDINGS: A qualitative analysis of the focus group transcript revealed nine categories. Three categories related specifically to the primary care physician: 1) the dual role physicians play as advocates for both patient and research; 2) threats to maintaining the primary care relationship; and 3) general philosophy toward prevention. An additional six categories could be subdivided as they apply to the primary care physician, the patient, and the community: 4) trust/commitment; 5) benefits of the research; 6) access to the research; 7) knowledge and recall of the research; 8) influences of media coverage about the research; and 9) cultural sensitivity. CONCLUSIONS: Investigators conducting cancer-prevention trials must address the concerns of primary care physicians to optimize recruitment of subjects- especially low-income and minority women-into trials. PMID:11730121

  17. Estimates of Intraclass Correlation Coefficients from Longitudinal Group-Randomized Trials of Adolescent HIV/STI/Pregnancy Prevention Programs

    ERIC Educational Resources Information Center

    Glassman, Jill R.; Potter, Susan C.; Baumler, Elizabeth R.; Coyle, Karin K.

    2015-01-01

    Introduction: Group-randomized trials (GRTs) are one of the most rigorous methods for evaluating the effectiveness of group-based health risk prevention programs. Efficiently designing GRTs with a sample size that is sufficient for meeting the trial's power and precision goals while not wasting resources exceeding them requires estimates of the…

  18. CLINICAL TRIALS OFFICE The principal charge of this focus group was to identify the key elements of a Clinical Trials

    E-print Network

    , education, and quality assurance. The Clinical Trials Office will also aggressively market the research personnel Assessment of candidate credentials Quality Control/Quality Assurance Provide investigators that include 1) planning and conducting high quality clinical research trials, 2) enhancing administrative

  19. On Sufism, Sufi Group Study and Group Leadership.

    ERIC Educational Resources Information Center

    Einhorn, Jay

    1979-01-01

    Sufism is an ancient tradition of experiential human development. Sufi human development specialists utilize the group setting as a major study format. Comparison with group counseling might broaden perspectives on the possibilities and pitfalls of group process, and pinpoint several important issues relevant to group leadership. (Author)

  20. Effectiveness of a psycho-educational group program for major depression in primary care: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Studies show the effectiveness of group psychoeducation in reducing symptoms in people with depression. However, few controlled studies that have included aspects of personal care and healthy lifestyle (diet, physical exercise, sleep) together with cognitive-behavioral techniques in psychoeducation are proven to be effective. The objective of this study is to assess the effectiveness of a psychoeducational program, which includes aspects of personal care and healthy lifestyle, in patients with mild/moderate depression symptoms in Primary Care (PC). Methods In a randomized, controlled trial, 246 participants over 20 years old with ICD-10 major depression were recruited through nurses/general practitioners at 12 urban Primary Care Centers (PCCs) in Barcelona. The intervention group (IG) (n=119) received a group psychoeducational program (12 weekly, 1.5 h sessions led by two nurses) and the control group (CG) (n=112) received usual care. Patients were assessed at baseline and at, 3, 6 and 9 months. The main outcome measures were the BDI, EQ-5D and remission based upon the BDI. Results 231 randomized patients were included, of whom 85 had mild depression and 146 moderate depression. The analyses showed significant differences between groups in relation to remission of symptoms, especially in the mild depression group with a high rate of 57% (p=0.009) at post-treatment and 65% (p=0.006) at 9 month follow up, and only showed significant differences on the BDI at post-treatment (p=0.016; effect size Cohen’s d’=.51) and at 6 and 9 month follow-up (p= 0.048; d’=.44). In the overall and moderate sample, the analyses only showed significant differences between groups on the BDI at post-treatment, p=0.02 (d’=.29) and p=0.010 (d’=.47), respectively. The psychoeducation group improved significantly on the EQ-5D at short and long-term. Conclusions This psychoeducational intervention is a short and long-term effective treatment for patients with mild depression symptoms. It results in a high remission rate, is recommended in PC and can be carried out by nurses with previous training. In moderate patients, group psychoeducation is effective in the short-term. Trial registration Clinical Trials.gov identifier NCT00841737 PMID:23249399

  1. Conducting randomised controlled trials across countries with disparate levels of socio-economic development: the experience of the Asia-Pacific Hepatocellular Carcinoma Trials Group.

    PubMed

    Kong, Nicole H Y; Chow, Pierce K H

    2013-11-01

    Hepatocellular carcinoma (HCC), which constitutes over 85-90% of all primary liver cancers, is the most predominant type of liver cancer, and the third leading cause of cancer related deaths in the world. While the Asia-Pacific is a highly heterogeneous region in geography, ethnicity and in the level of socio-economic development, the main burden of HCC falls in this region and there are compelling reasons and advantages to conduct definitive clinical trials in HCC where it is endemic. The Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group was established in 1997 and has faced and overcome challenges that are inherent in conducting clinical trials in a disparate region. Clinical trial infrastructure is rudimentary at many sites and requires significant effort to be expended on training and monitoring to ensure production of definitive data. The benefits of industrial support of Investigator-Initiated Trials are discussed in the context of the Asia-Pacific. The positive experience of the AHCC trials group would be valuable to any collaborative trials in countries with disparate levels of socio-economic development. PMID:23587539

  2. The EHR solution to clinical trial recruitment in physician groups. | accrualnet.cancer.gov

    Cancer.gov

    This article was written by the president and founder of the Holston Medical Group and explains his company’s success with an electronic health record (EHR). The EHR is used among 102 providers in 26 locations and has been used to enroll thousands of patients in more than 250 clinical trials. The Holston Medical Group has determined that the use of the EHR Web-based technology can significantly streamline patient recruitment, speed monitoring, and help to prevent protocol failure—all while increasing revenue stream.

  3. Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial

    PubMed Central

    2014-01-01

    Background Pressure ulcers are one of the most common health complaints, which often take months or years to heal, and affect patients’ morbidity and quality of life. Medical options for pressure ulcers are limited. Electroacupuncture (EA) has been employed to relieve the symptoms for patients with pressure ulcers, but there is limited clinical evidence for its effectiveness. Methods/Design This study consists of a randomized controlled trial (RCT) with two parallel arms: a control group and an EA group. Both groups will receive standard wound care (including changing position, using mattresses and cushions, and a good diet) of five sessions per week for a total of 40 sessions during the 8-week treatment period. In addition, the EA group will receive the EA intervention. The following outcome measurements will be used in examination of participants: wound surface area (WSA), visual analogue scale (VAS), and the proportion of ulcers healed within trial period (PUHTP). All the outcomes will be evaluated at the start of the study, at the end of the fourth week, at 8 weeks after randomization, and 1 month after treatment cessation. Discussion The aim of this study is to evaluate the effectiveness of EA for the treatment of patients with pressure ulcers. Trial registration Chinese Clinical Trial Register: ChiCTR-TRC-11001693 PMID:24393344

  4. The Effect of Spiritual and Religious Group Psychotherapy on Suicidal Ideation in Depressed Patients: A Randomized Clinical Trial

    PubMed Central

    Ebrahimi, Hossein; Kazemi, Abdul Hassan; Fallahi Khoshknab, Masoud; Modabber, Raheleh

    2014-01-01

    Introduction: Suicide is a great economical, social and public health problem. It is prevalent worldwide and has a lot of negative effects on individuals, families and society. Depression is often prelude to Suicide. An important part of the treatment of the mentally ill patients is spiritual-religious psychotherapy which should be done after physical treatment. The aim of this study was to determine the effect of spiritual and religious group psychotherapy on suicidal ideation in depressed patients. Methods: 51 depressed patients with suicidal ideation from Razi hospital (Tabriz, Iran) participated in this clinical trial. To collect Data questionnaire was used which included demographic and Beck Suicide Scale Ideation. Experimental group participated in 10 sessions of group psychotherapy. Each section lasted 1 hour. Two weeks after the last section post test was done. Statistical software SPSS ver 13 was used for data analysis. Results: Results of independent t-test revealed no difference between two groups in terms of suicidal ideation before intervention but after study there is a statistical difference. Also the results of ANCOVA test showed a significant relationship between spiritual group therapy and decrease in suicidal ideation, so that this intervention can make 57% of variance in suicidal ideation of experimental group. Conclusion: Regarding positive effect of spiritual and religious group psychotherapy on decreasing suicidal ideation of depressed patients, we suggest this intervention to be held in Psychiatric Wards and also more study on depression and other psychiatric patients with greater sample size would be helpful. PMID:25276756

  5. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies

  6. Factors Associated with Lack of Viral Suppression at Delivery among HAART-Naïve HIV-Positive Women in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1025 Study

    PubMed Central

    Katz, Ingrid T.; Leister, Erin; Kacanek, Deborah; Hughes, Michael D.; Bardeguez, Arlene; Livingston, Elizabeth; Stek, Alice; Shapiro, David E.; Tuomala, Ruth

    2014-01-01

    Background High delivery maternal plasma HIV-1 RNA level (viral load, VL) is a risk factor for mother to child transmission and poor maternal health. Objective To identify factors associated with detectable VL at delivery despite initiation of highly active antiretroviral therapy (HAART) during pregnancy. Design Multicenter observational study. Setting 67 US AIDS clinical research sites. Patients HIV-1-positive pregnant women who initiated HAART during pregnancy. Measurements Descriptive summaries and associations between socio-demographic, HIV disease, treatment and pregnancy-related risk factors and detectable VL (>400copies/mL) at delivery. Results Between October 2002 and December 2011, 671 women met inclusion criteria and 13% had detectable VL at delivery. Factors associated with detectable VL included multiparity (16.4% vs 8% nulliparous, p=0.002), black non-Hispanic ethnicity (17.6% vs 6.6% Hispanic and 6.6% white/non-Hispanic, p<0.001), 11th grade or less education (17.6% vs.12.1% high school graduate and 6.7% some college or higher, p=0.013), and initiation of HAART in third trimester (23.9% vs 12.3% second and 8.6% first, p=0.002), timing of HIV diagnosis prior to current pregnancy (16.1% vs 11% during current pregnancy, p=0.051), and timing of first prenatal visit in 3rd trimester (33.3% vs 14.3% second and 10.5% first, p=0.002). Women who experienced treatment interruptions or reported poor medication adherence during pregnancy were more likely to have detectable VL at delivery than women with no interruptions or who reported better adherence. Limitations Women entered the study at varying times during pregnancy and for this and other reasons there was incomplete data on many covariates. Conclusions In this large U.S.-based cohort of HIV-1 positive women, 13% of women who initiated HAART during pregnancy had detectable VL at delivery. The timing of HAART initiation and prenatal care along with medication adherence during pregnancy appear to be modifiable factors associated with detectable VL at delivery. Social factors such as Black/non-Hispanic ethnicity and less than high school education may help to identify women at highest risk who may benefit from focused efforts to promote early treatment initiation and adherence to HAART. Clinical Trial Registration Number NCT00028145 PMID:25599347

  7. Immune Response Gene Expression in Colorectal Cancer Carries Distinct Prognostic Implications According to Tissue, Stage and Site: A Prospective Retrospective Translational Study in the Context of a Hellenic Cooperative Oncology Group Randomised Trial

    PubMed Central

    Pentheroudakis, George; Raptou, Georgia; Kotoula, Vassiliki; Wirtz, Ralph M.; Vrettou, Eleni; Karavasilis, Vasilios; Gourgioti, Georgia; Gakou, Chryssa; Syrigos, Konstantinos N.; Bournakis, Evangelos; Rallis, Grigorios; Varthalitis, Ioannis; Galani, Eleni; Lazaridis, Georgios; Papaxoinis, George; Pectasides, Dimitrios; Aravantinos, Gerasimos; Makatsoris, Thomas; Kalogeras, Konstantine T.; Fountzilas, George

    2015-01-01

    Background Although host immune response is an emerging prognostic factor for colorectal cancer, there is no consensus on the optimal methodology, surrogate markers or tissue for study. Patients and Methods Tumour blocks were prospectively collected from 344 patients with stage II/III colorectal cancer (CRC) treated with adjuvant chemotherapy. Whole section lymphocytic infiltration was studied along with mRNA expression of CD3Z, CD8, CD4, CXCL9, CXCL13, IGHM, FOXP3, SNAI2 and ESR1 by qRT-qPCR in tissue microarray (TMA) cores from the centre of tumour, invasive margin and adjacent normal mucosa. Results Lymphocytic infiltration, deficient MMR (10.9%), KRAS (40.7%) and BRAF (4.9%) mutations or single mRNA gene expression were not prognostic. Tumour ESR1 gene expression (Hazard Ratio [HR] for relapse 2.33, 95% CI 1.35-4.02; HR for death 1.74, 95% CI 1.02-2.97) and absence of necrosis (HR for relapse 1.71, 95% CI 1.05-2.71; HR for death 1.98, 95% CI 1.14-3.43) were adverse prognostic features. We used CD3Z and CD8 expression in order to devise the mRNA-based Immune Score (mIS) and proceeded to partitioning analysis in 267 patients, with age, stage, tumour site (Right vs Left CRC), KRAS mutation and tumour mIS as input factors. Only in patients with stage III right-sided colon cancer, a low immune response was associated with inferior disease-free survival (mIS-low, HR for relapse 2.28, 95% CI 1.05-8.02). No prognostic significance was seen for tumour mIS in any other stage or site of CRC, or for a similar mIS score derived from adjacent normal mucosa. Independent adverse prognostic significance was retained in multivariable analysis for absence of necrosis, tumour ESR1 expression in all patients and low tumour mIS in stage III right-sided CRC. Conclusions In localised CRC, mRNA-based CD3Z/CD8 profiling of tumour immune response may have stage, site and tissue-specific prognostic significance, along with ESR1 expression. Trial Registration ANZCTR.org.au ACTRN12610000509066 PMID:25970543

  8. Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  9. After-School Multifamily Groups: A Randomized Controlled Trial Involving Low-Income, Urban, Latino Children

    ERIC Educational Resources Information Center

    McDonald, Lynn; Moberg, D. Paul; Brown, Roger; Rodriguez-Espiricueta, Ismael; Flores, Nydia I.; Burke, Melissa P.; Coover, Gail

    2006-01-01

    This randomized controlled trial evaluated a culturally representative parent engagement strategy with Latino parents of elementary school children. Ten urban schools serving low-income children from mixed cultural backgrounds participated in a large study. Classrooms were randomly assigned either either to an after-school, multifamily support…

  10. Community Group Involvement in a Fund Raising Project for a University Library: Examples from "A Trial for the Books".

    ERIC Educational Resources Information Center

    Finley, Mary M.

    This paper describes a unique library fund raiser at California State University (Northridge). "A Trial for the Books" was a dog agility trial held on April 26-27, 1996 as a benefit for the university's Oviatt Library. The event was hosted by West Valley DogSports, a community group. The event raised approximately $2,500 for the library's…

  11. Randomised trial of early tapping in neonatal posthaemorrhagic ventricular dilatation: results at 30 months. Ventriculomegaly Trial Group.

    PubMed Central

    1994-01-01

    One hundred and fifty seven infants with progressive ventricular dilatation after intraventricular haemorrhage were randomised to either early repeated cerebrospinal fluid tapping or conservative management. Thirty two (20%) infants died and 13 (8%) were lost to follow up. One hundred and twelve children (90% of survivors) were examined at 30 months by a single experienced examiner. Overall, 54 (48%) scored less than 70 on the Griffiths developmental scales, 101 (90%) had neuromotor impairment, and 85 (76%) had marked disability; 63 (56%) had multiple impairments. Vision was severely affected in 10 (9%) and 30 (27%) had a field defect. Six per cent (seven children) had sensorineural hearing loss and 16 (14%) were taking regular anticonvulsant drugs. Although early cerebrospinal fluid tapping reduced the rate of ventricular and head expansion, there was no statistically significant difference (at the 5% level) between the treatment groups in the prevalence of neuromotor impairments, non-neuromotor impairments, nor multiple impairments at 30 months. These findings were consistent regardless of the presence or absence of a parenchymal cerebral lesion at entry to the trial. In the light of these findings and the 7% risk of cerebrospinal fluid infection associated with repeated tapping, this form of early intervention cannot be recommended. PMID:7512322

  12. Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456 PMID:21592347

  13. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study)

    PubMed Central

    Gehring, Marta; Taylor, Rod S; Mellody, Marie; Casteels, Brigitte; Piazzi, Angela; Gensini, Gianfranco; Ambrosio, Giuseppe

    2013-01-01

    Objectives Applications to run clinical trials in Europe fell 25% between 2007 and 2011. Costs, speed of approvals and shortcomings of European Clinical Trial Directive are commonly invoked to explain this unsatisfactory performance. However, no hard evidence is available on the actual weight of these factors or has it been previously investigated whether other criteria may also impact clinical trial site selection. Design The Survey of Attitudes towards Trial sites in Europe (SAT-EU Study) was an anonymous, cross-sectional web-based survey that systematically assessed factors impacting European clinical trial site selection. It explored 19 factors across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Setting and participants Clinical research organisations (CROs), academic clinical trial units (CTUs) and industry invited to respond. Outcome measures Primary outcome: weight assigned to each factor hypothesised to impact trial site selection and trial incidence. Secondary outcome: desirability of European countries to run clinical trials. Results Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-dependent, environment-dependent and hospital-dependent factors were rated highly important, costs being less important (p<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives (p<0.0001). The pattern of response was consistent across respondent groupings (CTU vs CRO vs industry). Considerable variability was demonstrated in the perceived receptivity of countries to undertake clinical trials, with Germany, the UK and the Netherlands rated the best trial markets (p<0.0001). Conclusions Investigator-dependent factors and ease of approval dominate trial site selection, while costs appear less important. Fostering competitiveness of European clinical research may not require additional government spending/incentives. Rather, harmonisation of approval processes, greater visibility of centres of excellence and reduction of ‘hidden’ indirect costs, may bring significantly more clinical trials to Europe. PMID:24240138

  14. Randomised trials of STD treatment for HIV prevention: report of an international workshop. HIV/STD Trials Workshop Group.

    PubMed Central

    Hayes, R; Wawer, M; Gray, R; Whitworth, J; Grosskurth, H; Mabey, D

    1997-01-01

    Three community trials of the impact of STD treatment interventions on HIV incidence in rural populations have been completed or are in progress in Uganda and Tanzania. Investigators from these trials met for a joint technical workshop in Baltimore in May 1996. This report summarises the consensus of the workshop, with the aim of providing useful input to research on HIV intervention strategies. Issues discussed include: (i) the role of community randomised trials; (ii) strategies for STD management; (iii) epidemiological and statistical issues in the design and analysis of community randomised trials; (iv) diagnostic methods for STDs in population surveys; (v) treatment regimens for STDs in rural Africa; and (vi) ethical issues in community trials. PMID:9582456

  15. THE COOPERATIVE INTERNATIONAL NEUROMUSCULAR RESEARCH GROUP DUCHENNE NATURAL HISTORY STUDY: GLUCOCORTICOID TREATMENT PRESERVES CLINICALLY MEANINGFUL FUNCTIONAL MILESTONES AND REDUCES RATE OF DISEASE PROGRESSION AS MEASURED BY MANUAL MUSCLE TESTING AND OTHER COMMONLY USED CLINICAL TRIAL OUTCOME MEASURES

    PubMed Central

    HENRICSON, ERIK K.; ABRESCH, R. TED; CNAAN, AVITAL; HU, FENGMING; DUONG, TINA; ARRIETA, ADRIENNE; HAN, JAY; ESCOLAR, DIANA M.; FLORENCE, JULAINE M.; CLEMENS, PAULA R.; HOFFMAN, ERIC P.; McDONALD, CRAIG M.

    2014-01-01

    Introduction Glucocorticoid (GC) therapy in Duchenne muscular dystrophy (DMD) has altered disease progression, necessitating contemporary natural history studies. Methods The Cooperative Neuromuscular Research Group (CINRG) DMD Natural History Study (DMD-NHS) enrolled 340 DMD males, ages 2–28 years. A comprehensive battery of measures was obtained. Results A novel composite functional “milestone” scale scale showed clinically meaningful mobility and upper limb abilities were significantly preserved in GC-treated adolescents/young adults. Manual muscle test (MMT)-based calculations of global strength showed that those patients <10 years of age treated with steroids declined by 0.4±0.39 MMT unit/year, compared with ?0.4±0.39 MMT unit/year in historical steroid-naive subjects. Pulmonary function tests (PFTs) were relatively preserved in steroid-treated adolescents. The linearity and magnitude of decline in measures were affected by maturational changes and functional status. Conclusions In DMD, long-term use of GCs showed reduced strength loss and preserved functional capabilities and PFTs compared with previous natural history studies performed prior to the widespread use of GC therapy. PMID:23649481

  16. Reference datasets for bioequivalence trials in a two-group parallel design.

    PubMed

    Fuglsang, Anders; Schütz, Helmut; Labes, Detlew

    2015-03-01

    In order to help companies qualify and validate the software used to evaluate bioequivalence trials with two parallel treatment groups, this work aims to define datasets with known results. This paper puts a total 11 datasets into the public domain along with proposed consensus obtained via evaluations from six different software packages (R, SAS, WinNonlin, OpenOffice Calc, Kinetica, EquivTest). Insofar as possible, datasets were evaluated with and without the assumption of equal variances for the construction of a 90% confidence interval. Not all software packages provide functionality for the assumption of unequal variances (EquivTest, Kinetica), and not all packages can handle datasets with more than 1000 subjects per group (WinNonlin). Where results could be obtained across all packages, one showed questionable results when datasets contained unequal group sizes (Kinetica). A proposal is made for the results that should be used as validation targets. PMID:25488055

  17. Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism

    PubMed Central

    2014-01-01

    Background Serotonin reuptake inhibitors (SSRIs) are commonly prescribed off-label for children with autism. To date, clinical trials examining the use of SSRIs in autism have been limited by small sample sizes and inconclusive results. The efficacy and safety of SSRIs for moderating autistic behaviors is yet to be adequately examined to provide evidence to support current clinical practice. The aim of the Fluoxetine for Autistic Behaviors (FAB) study is to determine the efficacy and safety of low dose fluoxetine compared with placebo, for reducing the frequency and severity of repetitive stereotypic behaviors in children and adolescents with an autism spectrum disorder (ASD). The relationship between the effectiveness of fluoxetine treatment and serotonin transporter genotype will also be explored. Methods/Design The FAB study is a multicenter, double-blinded, randomized controlled trial, funded by the Australian Government’s National Health and Medical Research Council (NHMRC) grant. Participants will be aged between 7.5 and 17 years with a confirmed diagnosis of ASD. Eligible participants will be randomized to either placebo or fluoxetine for a 16-week period. Medication will be titrated over the first four weeks. Reponses to medication will be monitored fortnightly using the Clinical Global Impressions Scale (CGI). The primary outcome measure is the Children’s Yale-Brown Obsessive Compulsive Scale-Modified for Pervasive Developmental Disorders (CYBOCS-PDD), administered at baseline and 16 weeks. Secondary outcome measures include the Aberrant Behaviour Scale (ABC), the Spence Children’s Anxiety Scale Parent Report (SCAS-P), and the Repetitive Behaviors Scale (RBS-R), measured at baseline and 16 weeks. Participants will be invited to undergo genetic testing for SLC6A4 allele variants using a cheek swab. Continuous outcomes, including the primary outcome will be compared between the active and placebo groups using unadjusted linear regression. Binary outcomes will be compared using unadjusted logistic regression. Discussion The FAB study is a large clinical trial to specifically investigate the efficacy of low dose fluoxetine for restricted, repetitive, and stereotyped behaviors in ASD. The outcomes of this study will contribute to evidence-based interventions used in clinical practice to assist children with ASD. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12608000173392; registered on 9 April, 2008. PMID:24934401

  18. Sniffing around oxytocin: review and meta-analyses of trials in healthy and clinical groups with implications for pharmacotherapy

    PubMed Central

    Bakermans-Kranenburg, M J; van IJzendoorn, M H

    2013-01-01

    The popularity of oxytocin (OT) has grown exponentially during the past decade, and so has the number of OT trials in healthy and clinical groups. We take stock of the evidence from these studies to explore potentials and limitations of pharmacotherapeutic applications. In healthy participants, intranasally administered OT leads to better emotion recognition and more trust in conspecifics, but the effects appear to be moderated by context (perceived threat of the ‘out-group'), personality and childhood experiences. In individuals with untoward childhood experiences, positive behavioral or neurobiological effects seem lowered or absent. In 19 clinical trials, covering autism, social anxiety, postnatal depression, obsessive-compulsive problems, schizophrenia, borderline personality disorder and post-traumatic stress, the effects of OT administration were tested, with doses ranging from 15?IU to more than 7000?IU. The combined effect size was d=0.32 (N=304; 95% confidence interval (CI): 0.18–0.47; P<0.01). However, of all disorders, only studies on autism spectrum disorder showed a significant combined effect size (d=0.57; N=68; 95% CI: 0.15–0.99; P<0.01). We hypothesize that for some of the other disorders, etiological factors rooted in negative childhood experiences may also have a role in the diminished effectiveness of treatment with OT. PMID:23695233

  19. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals. As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. Methods/design We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only. The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program. Discussion This study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609000507280 PMID:23369724

  20. Doing Anger Differently: Two Controlled Trials of Percussion Group Psychotherapy for Adolescent Reactive Aggression

    ERIC Educational Resources Information Center

    Currie, Michael; Startup, Mike

    2012-01-01

    This study evaluates efficacy and effectiveness of "Doing Anger Differently" (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1,…

  1. Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. Methods/Design Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). Discussion Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. Trial registration Netherlands Trial Register, NTR3571 PMID:24467861

  2. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice. Trial registration Current Controlled Trials ISRCTN33031001. Registered 27 April 2012. PMID:25052334

  3. Outcome of advanced chronic lymphocytic leukemia following different first-line and relapse therapies: a meta-analysis of five prospective trials by the German CLL Study Group (GCLLSG).

    PubMed

    Cramer, Paula; Isfort, Susanne; Bahlo, Jasmin; Stilgenbauer, Stephan; Döhner, Hartmut; Bergmann, Manuela; Stauch, Martina; Kneba, Michael; Lange, Elisabeth; Langerbeins, Petra; Pflug, Natali; Kovacs, Gabor; Goede, Valentin; Fink, Anna-Maria; Elter, Thomas; Fischer, Kirsten; Wendtner, Clemens-Martin; Hallek, Michael; Eichhorst, Barbara

    2015-11-01

    To evaluate the effect of first-line and subsequent therapies, the outcome of 1,558 patients with chronic lymphocytic leukemia from five prospective phase II/III trials conducted between 1999 and 2010 was analyzed. The 3-year overall survival rate was higher after first-line treatment with chemoimmunotherapies such as fludarabine/cyclophosphamide/rituximab (87.9%) or bendamustine/rituximab (90.7%) compared to chemotherapies without an antibody (fludarabine/cyclophosphamide: 84.6%; fludarabine: 77.5%; chlorambucil: 77.4%). Furthermore, the median overall survival was longer in patients receiving at least one antibody-containing regimen in any treatment line (94.4 months) compared to the survival in patients who never received an antibody (84.3 months, P<0.0001). Univariate Cox regression analysis demonstrated that patients who did receive antibody treatment had a 1.42-fold higher risk of death (hazard ratio, 1.42; 95% confidence interval: 1.185-1.694). Therapies administered at relapse were very heterogeneous. Only 55 of 368 patients (14.9%) who started second-line treatment >24 months after first-line therapy repeated the first-line regimen. Among 315 patients requiring treatment ?24 months after first-line therapy, cyclophosphamide/doxorubicin/vincristine/prednisone with or without rituximab as well as alemtuzumab were the most commonly used therapies. In these early relapsing patients, the median overall survival was shorter following therapies containing an anthracycline and/or three or more cytotoxic agents (e.g. cyclophosphamide/doxorubicin/vincristine/prednisone or fludarabine/cyclophosphamide/mitoxantrone, 30.0 months) compared to single agent chemotherapy (e.g. fludarabine; 39.6 months) and standard chemoimmunotherapy (e.g. fludarabine/cyclophosphamide/rituximab: 61.6 months). In conclusion, the analysis confirms the superior efficacy of chemoimmunotherapies in patients with chronic lymphocytic leukemia. Moreover, the use of aggressive chemo(immuno)therapy combinations in patients with an early relapse does not offer any benefit when compared to less intensive therapies. Trial identifier: NCT00281918, ISRCTN75653261, ISRCTN36294212, NCT00274989 and NCT00147901. PMID:26315931

  4. Two-group randomised, parallel trial of cognitive and exposure therapies for problem gambling: a research protocol

    PubMed Central

    Smith, David P; Battersby, Malcolm W; Harvey, Peter W; Pols, Rene G; Ladouceur, Robert

    2013-01-01

    Background Problem gambling is a serious public health concern at an international level where population prevalence rates average 2% or more and occurs more frequently in younger populations. The most empirically established treatments until now are combinations of cognitive and behavioural techniques labelled cognitive behaviour therapy (CBT). However, there is a paucity of high quality evidence for the comparative efficacy of core CBT interventions in treating problem gamblers. This study aims to isolate and compare cognitive and behavioural (exposure-based) techniques to determine their relative efficacy. Methods A sample of 130 treatment-seeking problem gamblers will be allocated to either cognitive or exposure therapy in a two-group randomised, parallel design. Repeated measures will be conducted at baseline, mid and end of treatment (12 sessions intervention period), and at 3, 6 and 12?months (maintenance effects). The primary outcome measure is improvement in problem gambling severity symptoms using the Victorian Gambling Screen (VGS) harm to self-subscale. VGS measures gambling severity on an extensive continuum, thereby enhancing sensitivity to change within and between individuals over time. Discussion This article describes the research methods, treatments and outcome measures used to evaluate gambling behaviours, problems caused by gambling and mechanisms of change. This study will be the first randomised, parallel trial to compare cognitive and exposure therapies in this population. Ethics and dissemination The study was approved by the Southern Adelaide Health Service/Flinders University Human Research Ethics Committee. Study findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN 12610000828022. PMID:23811176

  5. Characteristics associated with informed consent for genetic studies in the ACCORD trial

    PubMed Central

    Simons-Morton, Denise G.; Chan, Jeffrey C.; Kimel, Angela R.; Linz, Peter E.; Stowe, Cynthia L.; Summerson, John; Ambrosius, Walter T.

    2014-01-01

    Background Prior studies found some groups have lower genetic consent rates than others. Participant consent for genetic studies enables randomized trials to examine effects of interventions compared to control in participants with different genotypes. Methods Unadjusted and multivariate associations between genetic consent rates and participant, study, and consent characteristics in 9,573 participants approached for genetics consent in the multicenter Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which used a layered genetics consent. Results Eighty-nine percent of eligible participants consented to genetic studies (“Any Consent”) and 64.7% consented to studies of any genes by any investigator (“Full Consent”), with similar rates in randomized groups. Controlling for multiple characteristics, African-Americans had lower consent rates than others (Any Consent Odds Ratio, OR = 0.62, p=0.0004; Full Consent OR = 0.67, p<0.0001). Those with high school or higher education had higher rates than less than high school graduation (Full Consent ORs 1.41-1.69, p-values <0.0001). Consent rates were lower when genetics consent was separate from the main trial consent on the same day (Any Consent OR 0.30; Full Consent OR 0.52, p values <0.0001) or on a subsequent day (Any Consent OR 0.70, p=0.0022; Full Consent OR 0.76, p=0.0002). Conclusion High rates of consent for genetic studies can be obtained in complex randomized trials, with lower consent rates in African-Americans, in participants with less than high-school education, and for sharing samples with other investigators. A genetics consent separated from the main trial consent was associated with lower consent rates. PMID:24355197

  6. Group Performance in Information Systems Project Groups: An Empirical Study

    ERIC Educational Resources Information Center

    Bahli, Bouchaib; Buyukkurt, Meral Demirbag

    2005-01-01

    The importance of teamwork in Information Systems Development (ISD) practice and education has been acknowledged but not studied extensively to date. This paper tests a model of how groups participating in ISD projects perform and examines the relationships between some antecedents of this performance based on group research theory well…

  7. Clinical Trial Adaptation by Matching Evidence in Complementary Patient Sub-groups of Auxiliary Blinding Questionnaire Responses

    PubMed Central

    Arandjelovi?, Ognjen

    2015-01-01

    Clinical trial adaptation refers to any adjustment of the trial protocol after the onset of the trial. Such adjustment may take on various forms, including the change in the dose of administered medicines, the frequency of administering an intervention, the number of trial participants, or the duration of the trial, to name just some possibilities. The main goal is to make the process of introducing new medical interventions to patients more efficient, either by reducing the cost or the time associated with evaluating their safety and efficacy. The principal challenge, which is an outstanding research problem, is to be found in the question of how adaptation should be performed so as to minimize the chance of distorting the outcome of the trial. In this paper we propose a novel method for achieving this. Unlike most of the previously published work, our approach focuses on trial adaptation by sample size adjustment i.e. by reducing the number of trial participants in a statistically informed manner. We adopt a stratification framework recently proposed for the analysis of trial outcomes in the presence of imperfect blinding and based on the administration of a generic auxiliary questionnaire that allows the participants to express their belief concerning the assigned intervention (treatment or control). We show that this data, together with the primary measured variables, can be used to make the probabilistically optimal choice of the particular sub-group a participant should be removed from if trial size reduction is desired. Extensive experiments on a series of simulated trials are used to illustrate the effectiveness of our method. PMID:26161797

  8. Effectiveness of heat-sensitive moxibustion in the treatment of lumbar disc herniation: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Lumbar disc herniation is a common and costly problem. Moxibustion is employed to relieve symptoms and might therefore act as a therapeutic alternative. Many studies have already reported encouraging results in heat-sensitive moxibustion for lumbar disc herniation. Hence, we designed a randomized controlled clinical trial to investigate the effectiveness of heat-sensitive moxibustion compared with conventional moxibustion. Methods This trial is a multicenter, prospective, randomized controlled clinical trial. The 316 eligible patients are randomly allocated to two different groups. The experimental group is treated with heat-sensitive moxibustion (n = 158); while the control group (n = 158) is treated with conventional moxibustion. The moxibustion locations are different for the groups. The experimental group selects heat-sensitization acupoints from the region which consists of bilateral Da Changshu (BL25) and Yao Shu (Du2). Meanwhile, fixed acupoints are used in control group; patients in both groups receive 18 sessions in 2 weeks. Discussion The study design guarantees a high internal validity for the results. It is one large-scale randomized controlled trial to evaluate the efficacy of heat-sensitive moxibustion compared to conventional moxibustion and may provide evidence for this therapy as a treatment for moderate and severe lumbar disc herniation. Moreover, the result may uncover the inherent laws to improve the therapeutic effect with suspended moxibustion. Trial Registration The trial is registered at Chinese Clinical Trials Registry: ChiCTR-TRC-09000604. The application date was 27 November 2009. The first patient was randomized on the 16 June 2011. PMID:21995679

  9. Presentation of continuous outcomes in randomised trials: an observational study

    PubMed Central

    2012-01-01

    Objective To characterise the percentage of available outcome data being presented in reports of randomised clinical trials with continuous outcome measures, thereby determining the potential for incomplete reporting bias. Design Descriptive cross sectional study. Data sources A random sample of 200 randomised trials from issues of 20 medical journals in a variety of specialties during 2007–09. Main outcome measures For each paper’s best reported primary outcome, we calculated the fraction of data reported using explicit scoring rules. For example, a two arm trial with 100 patients per limb that reported 2 sample sizes, 2 means, and 2 standard deviations reported 6/200 data elements (1.5%), but if that paper included a scatterplot with 200 points it would score 200/200 (100%). We also assessed compliance with 2001 CONSORT items about the reporting of results. Results The median percentage of data reported for the best reported continuous outcome was 9% (interquartile range 3–26%) but only 3.5% (3–7%) when we adjusted studies to 100 patients per arm to control for varying study size; 17% of articles showed 100% of the data. Tables were the predominant means of presenting the most data (59% of articles), but papers that used figures reported a higher proportion of data. There was substantial heterogeneity among journals with respect to our primary outcome and CONSORT compliance. Limitations We studied continuous outcomes of randomised trials in higher impact journals. Results may not apply to categorical outcomes, other study designs, or other journals. Conclusions Trialists present only a small fraction of available data. This paucity of data may increase the potential for incomplete reporting bias, a failure to present all relevant information about a study’s findings. PMID:23249670

  10. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies (virtual reality, advanced sensors and smartphones) is a feasible way to address actual limitations of existing protocols for psychological stress. Trial registration http://clinicaltrials.gov/ct2/show/NCT01683617 PMID:23806013

  11. Establishing the Irish Critical Care Trials Group: 'who wins in battle makes many calculations before the battle is fought'

    PubMed Central

    O'Brien, Brian; Phelan, Dermot

    2008-01-01

    Quality research, requiring large numbers of participants, in the intensive care unit (ICU) population requires multicentre collaboration. Although logistically challenging, this methodology reduces the influence of individual units and has greater validity and broader relevance to patients and practitioners. The nascent Irish Critical Care Trials Group opens additional such opportunities. In the accompanying epidemiologic study, the group present data gathered over 10 weeks of 2006 describing 1,029 patients, from 10 Irish ICUs representing over one-half of Ireland's critical care bed capacity. The data depict a busy service, with 78% of admissions being emergent and with a moderately high (7%) readmission rate. While recognising that there were missing data, the outcomes in organ failure and sepsis – where international definitions exist – and the ICU survival rate (83%) were consistent with international standards. The achievement of this planned first epidemiological step lays the foundation for the conduct of prospective scientific studies. These studies might occur in Ireland or in cooperation with other audit/scientific groups such as the UK's Intensive Care National Audit and Research Centre, the European Critical Care Research Network, or others. This brings us a small step closer to the prospect of global, high-volume studies in critical care. PMID:18947367

  12. Southeastern Cancer Study Group: breast cancer studies

    SciTech Connect

    Smalley, R.V.; Bartolucci, A.A.; Moore, M.

    1983-12-01

    During the past 10 years, the Southeastern Cancer Study Group (SECSG) has been engaged in one major adjuvant study and three major advanced disease studies for patients with adenocarcinoma of the breast. The adjuvant study is demonstrating that six months of adjuvant CMF is the therapeutic equivalent of 12 months and that post-operative irradiation is of no added therapeutic benefit. In patients with advanced disease, a low dose 5 drug combination of CMFVP induces more objective responses than single agent 5FU, but improves survival only for those patients with liver metastases when compared to the sequential use of the same 5 single agents. The three drug combination, CAF, utilizing doxorubicin, induces more objective responses than low dose CMFVP, but it does not improve overall survival. The addition of a phase active combination, CAMELEON, (i.e., sequentially alternating therapy) of CAF has not improved the duration of disease control and survival for patients with liver metastases, lymphangitic and nodular lung metastases compared to CAF. Aggressive combination chemotherapeutic approaches to patients with advanced disease provide better and longer disease and tumor control but only marginal improvements in overall survival. Adding additional agents to a maximally tolerable regimen has not improved the therapeutic outcome.

  13. TEACCH-based group social skills training for children with high-functioning autism: a pilot randomized controlled trial

    PubMed Central

    2013-01-01

    Background Although social skills training programs for people with high-functioning autism (HFA) are widely practiced, the standardization of curricula, the examination of clinical effectiveness, and the evaluation of the feasibility of future trials have yet to be done in Asian countries. To compensate for this problem, a Japanese pilot randomized controlled trial (RCT) of the Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted. Methods Eleven children with HFA, aged 5–6 years, and their mothers were randomly assigned to the TEACCH program (n=5) or a waiting-list control group (n=6). The program involved comprehensive group intervention and featured weekly 2-hour sessions, totaling 20 sessions over six months. The adaptive behaviors and social reciprocity of the children, parenting stress, and parent–child interactions were assessed using the Strengths and Difficulties Questionnaire (SDQ), Parenting Stress Index (PSI), Beck depression inventory-II (BDI-II), and Interaction Rating Scale (IRS). Results Through this pilot trial, the intervention and evaluation of the program has been shaped. There were no dropouts from the program and the mothers’ satisfaction was high. The outcome measurements improved more in the program group than in the control group, with moderate effect sizes (SDQ, 0.71; PSI, 0.58; BDI-II, 0.40; and IRS, 0.69). This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not. Conclusion We have standardized the TEACCH program, confirmed the feasibility of a future trial, and successfully estimated the positive effect size. These findings will contribute to a larger trial in the future and to forthcoming systematic reviews with meta-analyses. Trial registration UMIN000004560 PMID:24083413

  14. Clinical Trials

    MedlinePLUS

    Clinical Trials Check out We Search Together , a searchable database that connects qualified study participants to researchers ... Brochure (PDF) Learn more about participating in reseach Clinical Trials A clinical trial is a study to ...

  15. Families Matter in Long-Term Care: Results of a Group-Randomized Trial

    PubMed Central

    Zimmerman, Sheryl; Cohen, Lauren W.; Reed, David; Gwyther, Lisa P.; Washington, Tiffany; Cagle, John G.; Sloane, Philip D.; Preisser, John S.

    2013-01-01

    This group-randomized trial implemented and evaluated an intervention to reduce staff burden and improve family and resident outcomes by helping families create meaningful roles for themselves in residential care/assisted living and nursing homes. Across 24 sites, families (N = 490) and staff (N = 397) provided data over six months about family involvement, family and staff well-being and attitudes, and resident quality of life. Intervention subjects participated in workshops and created service plans to identify family roles. For families, the intervention decreased burden and improved resident quality of life but also increased guilt and conflict. Staff reported less burnout and greater partnership with families, and felt families were more empathic. Consequently, there are benefits to increasing family involvement, but attention must be paid to potential barriers and negative outcomes. PMID:25243051

  16. Changes in the Precision of a Study from Planning Phase to Implementation Phase: Evidence from the First Wave of Group Randomized Trials Launched by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Lininger, Monica; Cullen, Anne

    2011-01-01

    The purpose of this study is to extend the work of Spybrook and Raudenbush (2009) and examine how the research designs and sample sizes changed from the planning phase to the implementation phase in the first wave of studies funded by IES. The authors examine the impact of the changes in terms of the changes in the precision of the study from the…

  17. Bath additives for the treatment of childhood eczema (BATHE): protocol for multicentre parallel group randomised trial

    PubMed Central

    Santer, Miriam; Rumsby, Kate; Ridd, Matthew J; Francis, Nick A; Stuart, Beth; Chorozoglou, Maria; Wood, Wendy; Roberts, Amanda; Thomas, Kim S; Williams, Hywel C; Little, Paul

    2015-01-01

    Introduction Bath emollients are widely prescribed for childhood eczema, yet evidence of their benefits over direct application of emollients is lacking. Objectives To determine the clinical and cost-effectiveness of adding bath emollient to the standard management of eczema in children Methods and analysis Design: Pragmatic open 2-armed parallel group randomised controlled trial. Setting: General practitioner (GP) practices in England and Wales. Participants: Children aged over 12?months and less than 12?years with eczema, excluding inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale). Interventions: Children will be randomised to either bath emollients plus standard eczema care or standard eczema care only. Outcome measures: Primary outcome is long-term eczema severity, measured by the Patient-Oriented Eczema Measure (POEM) repeated weekly for 16?weeks. Secondary outcomes include: number of eczema exacerbations resulting in healthcare consultations over 1?year; eczema severity over 1?year; disease-specific and generic quality of life; medication use and healthcare resource use; cost-effectiveness. Aiming to detect a mean difference between groups of 2.0 (SD 7.0) in weekly POEM scores over 16?weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up, gives a total sample size of 423 children. We will use repeated measures analysis of covariance, or a mixed model, to analyse weekly POEM scores. We will control for possible confounders, including baseline eczema severity and child's age. Cost-effectiveness analysis will be carried out from a National Health Service (NHS) perspective. Ethics and dissemination This protocol was approved by Newcastle and North Tyneside 1 NRES committee 14/NE/0098. Follow-up will be completed in 2017. Findings will be disseminated to participants and carers, the public, dermatology and primary care journals, guideline developers and decision-makers. Trial registration number ISRCTN84102309. PMID:26525422

  18. Factors associated with attrition from a randomized controlled trial of meaning-centered group psychotherapy for patients with advanced cancer

    PubMed Central

    Applebaum, Allison J.; Lichtenthal, Wendy G.; Pessin, Hayley A.; Radomski, Julia N.; Gökbayrak, N. Simay; Katz, Aviva M.; Rosenfeld, Barry; Breitbart, William

    2013-01-01

    Objective The generalizability of palliative care intervention research is often limited by high rates of study attrition. This study examined factors associated with attrition from a randomized controlled trial comparing meaning-centered group psychotherapy (MCGP), an intervention designed to help advanced cancer patients sustain or enhance their sense of meaning to the supportive group psychotherapy (SGP), a standardized support group. Methods Patients with advanced solid tumor cancers (n = 153) were randomized to eight sessions of either the MCGP or SGP. They completed assessments of psychosocial, spiritual, and physical well-being pretreatment, midtreatment, and 2 months post-treatment. Attrition was assessed in terms of the percent of participants who failed to complete these assessments, and demographic, psychiatric, medical, and study-related correlates of attrition were examined for the participants in each of these categories. Results The rates of attrition at these time points were 28.1%, 17.7%, and 11.1%, respectively; 43.1% of the participants (66 of 153) completed the entire study. The most common reason for dropout was patients feeling too ill. Attrition rates did not vary significantly between study arms. The participants who dropped out pretreatment reported less financial concerns than post-treatment dropouts, and the participants who dropped out of the study midtreatment had poorer physical health than treatment completers. There were no other significant associations between attrition and any demographic, medical, psychiatric, or study-related variables. Conclusions These findings highlight the challenge of maintaining advanced cancer patients in longitudinal research and suggest the need to consider alternative approaches (e.g., telemedicine) for patients who might benefit from group interventions but are too ill to travel. PMID:21751295

  19. Effect of Gross Motor Group Exercise on Functional Status in Chronic Stroke: A Randomized Controlled Trial

    PubMed Central

    Kim, Kwanghyun; Lee, Byungjoon; Lee, Wanhee

    2014-01-01

    [Purpose] The aim of this study was to understand the effects of task-oriented gross motor group exercise based on motor development on chronic stroke patients’ joint, bone, muscle, and motor functions and activities of daily living. [Subjects] Twenty-eight stroke patients hospitalized at P municipal nursing facility for the severely handicapped were randomly assigned to the gross motor group exercise group (experimental group, n=14) or the control group (n=14). [Methods] The two groups performed morning exercise led by a trainer for 30 minutes a day, 5 times a week for 6 weeks in total. The experimental group performed a gross motor group exercise in addition to this exercise for 50 minutes a day, 3 times a week for 6 weeks in total. Before the experiment, all subjects were measured with the Modified Barthel Index (MBI) and for their neuromuscular skeletal and motor-related functions according to the International Classification of Functioning, Disability and Health. [Results] Significant improvements were found in the experimental group’s neuromusculoskeletal and motor-related functions and MBI test, except for the stability of joint functions. The control group showed no significant difference from the initial evaluation. [Conclusion] The gross motor group exercise based on motor development is recommended for chronic stroke patients with severe handicaps. PMID:25140077

  20. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH2O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure ?30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method. Trial registration ClinicalTrials.gov Identifier: NCT01374022 PMID:22929542

  1. A Randomized Trial of Contingency Management Delivered in the Context of Group Counseling

    ERIC Educational Resources Information Center

    Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.

    2011-01-01

    Objective: Contingency management (CM) is efficacious in reducing drug use. Typically, reinforcers are provided on an individual basis to patients for submitting drug-negative samples. However, most treatment is provided in a group context, and poor attendance is a substantial concern. This study evaluated whether adding CM to group-based…

  2. Group-Based Randomized Trial of Contingencies for Health and Abstinence in HIV Patients

    ERIC Educational Resources Information Center

    Petry, Nancy M.; Weinstock, Jeremiah; Alessi, Sheila M.; Lewis, Marilyn W.; Dieckhaus, Kevin

    2010-01-01

    Objective: Contingency management (CM) treatments are usually applied individually for drug abstinence, but CM can also be targeted toward health behaviors and implemented in groups. This study evaluated effects of a group-based CM intervention that focused on reinforcing health behaviors. Method: HIV-positive patients with cocaine or opioid use…

  3. Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans.

    PubMed

    Frew, Paula M; Schamel, Jay T; O'Connell, Kelli A; Randall, Laura A; Boggavarapu, Sahithi

    2015-01-01

    This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans' (AA) participation in clinical trials. Two hundred and twenty-one AA subjects ages ?50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six months. A statistically significant increase in the intention to obtain clinical trial information at the three and six month time points was observed in the intervention group, but not the control group. Older participants (65-95 years) were less likely than younger participants (50-64 years) to increase their motivation to seek clinical trial information by the three and six month time points. No significant increases were observed in intention to join clinical trials. This randomized trial shows that AA church-based educational interventions are likely to increase the motivation of AA subjects to obtain clinical trial information and are therefore potentially effective at ameliorating the underrepresentation of AA subjects in clinical trials. PMID:26703671

  4. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ...Industry on Postmarketing Studies and Clinical Trials--Implementation of Section...entitled ``Postmarketing Studies and Clinical Trials--Implementation of Section...require certain postmarketing studies and clinical trials for prescription drugs...

  5. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    PubMed Central

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ?18?years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16?mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21?mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12?weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p?=?0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products. Trial registration Australian NZ Clinical Trials Registry (ACTRN12610000866000). PMID:23496861

  6. Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial;Bone; Lymphoma; Radiotherapy; Chemotherapy; Clinical trial

    SciTech Connect

    Christie, David; Dear, Keith; Le, Thai; Barton, Michael; Wirth, Andrew; Porter, David; Roos, Daniel; Pratt, Gary

    2011-07-15

    Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

  7. Risk factors for readmission in patients with ovarian, fallopian tube, and primary peritoneal carcinoma who are receiving front-line chemotherapy on a clinical trial (GOG 218): an NRG oncology/gynecologic oncology group study (ADS-1236)?

    PubMed Central

    Duska, Linda R.; Java, James J.; Cohn, David E.; Burger, Robert A.

    2015-01-01

    Background Readmission within 30 days is a measure of care quality. Ovarian cancer patients are at high risk for readmission, but specific risk factors are not defined. This study was designed to determine risk factors in patients with ovarian cancer receiving upfront surgery and chemotherapy. Methods The study population was enrolled to GOG 0218. Factors predictive of admission within 30 days of a previous admission or 40 days of cytoreductive surgery were investigated. Categorical variables were compared by Pearson chi-square test, continuous variables by Wilcoxon–Mann–Whitney test. A logistic regression model was used to evaluate independent prognostic factors and to estimate covariate-adjusted odds. All tests were two-tailed, ? = 0.05. Results Of 1873 patients, 197 (10.5%) were readmitted, with 59 experiencing >1 readmission. One-hundred-forty-four (73%) readmissions were post-operative (readmission rate 7.7%). Significant risk factors include: disease stage (stage 3 vs 4, p = 0.008), suboptimal cytoreduction (36% vs 64%, p = 0.001), ascites, (p = 0.018), BMI (25.4 vs 27.6, p < 0.001), poor PS (p < 0.001), and higher baseline CA 125 (p = 0.017). Patients readmitted within 40 days of surgery had a significantly shorter interval from surgery to chemotherapy initiation (22 versus 32 days, p < 0.0001). Patients treated with bevacizumab had higher readmission rates in the case of patients with >1 readmission. On multivariate analysis, the odds of re-hospitalization increased with doubling of BMI (OR = 1.81, 95% CI: 1.07–3.07) and PS of 2 (OR = 2.05, 95% CI 1.21–3.48). Conclusion Significant risk factors for readmission in ovarian cancer patients undergoing primary surgery and chemotherapy include stage, residual disease, ascites, high BMI and poor PS. Readmissions are most likely after the initial surgical procedure, a discrete period to target with a prospective intervention. PMID:26335594

  8. Non-pharmacological, multicomponent group therapy in patients with degenerative dementia: a 12-month randomzied, controlled trial

    PubMed Central

    2011-01-01

    Background Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia. Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care. Methods A randomized, controlled, single-blind longitudinal trial was conducted with 98 patients (follow-up: n = 61) with primary degenerative dementia in five nursing homes in Bavaria, Germany. The highly standardized intervention consisted of motor stimulation, practice in activities of daily living, and cognitive stimulation (acronym MAKS). It was conducted in groups of ten patients led by two therapists for 2 hours, 6 days a week for 12 months. Control patients received treatment as usual. Cognitive function was assessed using the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living (E-ADL test) at baseline and after 12 months. Results Of the 553 individuals screened, 119 (21.5%) were eligible and 98 (17.7%) were ultimately included in the study. At 12 months, the results of the per protocol analysis (n = 61) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients (ADAS-Cog: adjusted mean difference: -7.7, 95% CI -14.0 to -1.4, P = 0.018, Cohen's d = 0.45; E-ADL test: adjusted mean difference: 3.6, 95% CI 0.7 to 6.4, P = 0.015, Cohen's d = 0.50). The effect sizes for the intervention were greater in the subgroup of patients (n = 50) with mild to moderate disease (ADAS-Cog: Cohen's d = 0.67; E-ADL test: Cohen's d = 0.69). Conclusions A highly standardized, non-pharmacological, multicomponent group intervention conducted in a nursing-home setting was able to postpone a decline in cognitive function in dementia patients and in their ability to carry out activities of daily living for at least 12 months. Trial Registration http://www.isrctn.com Identifier: ISRCTN87391496 PMID:22133165

  9. Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. | accrualnet.cancer.gov

    Cancer.gov

    This paper may be useful for researchers interested in enhancing their interactions with community physicians and increasing the number of minority patients referred to clinical trials. It describes a study conducted by the Eastern Cooperative Oncology Group (ECOG) in collaboration with the National Medical Association (NMA) to better understand barriers and solutions to African-American (AA) accrual and to test several recommended low-cost strategies.

  10. Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial

    PubMed Central

    2013-01-01

    Background There is a paucity of methodologically robust vocational rehabilitation (VR) intervention trials. This study assessed the feasibility and acceptability of a VR trial of women with breast cancer to inform the development of a larger interventional study. Methods Women were recruited in Scotland and randomised to either a case management VR service or to usual care. Data were collected on eligibility, recruitment and attrition rates to assess trial feasibility, and interviews conducted to determine trial acceptability. Sick leave days (primary outcome) were self-reported via postal questionnaire every 4 weeks during the first 6 months post-surgery and at 12 months. Secondary outcome measures were change in employment pattern, quality of life and fatigue. Results Of the 1,114 women assessed for eligibility, 163 (15%) were eligible. The main reason for ineligibility was age (>65 years, n = 637, 67%). Of those eligible, 111 (68%) received study information, of which 23 (21%) consented to participate in the study. Data for 18 (78%) women were analysed (intervention: n = 7; control: n = 11). Participants in the intervention group reported, on average, 53 fewer days of sick leave over the first 6 months post-surgery than those in the control group; however, this difference was not statistically significant (p = 0.122; 95% confidence interval ?15.8, 122.0). No statistically significant differences were found for secondary outcomes. Interviews with trial participants indicated that trial procedures, including recruitment, randomisation and research instruments, were acceptable. Conclusions Conducting a pragmatic trial of effectiveness of a VR intervention among cancer survivors is both feasible and acceptable, but more research about the exact components of a VR intervention and choice of outcomes to measure effectiveness is required. VR to assist breast cancer patients in the return to work process is an important component of cancer survivorship plans. Trial registration ISRCTN29666484 PMID:23768153

  11. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    PubMed Central

    Park, Jimin; Kim, Hyun Soo; Lee, Seung Min; Yoon, Kanghyun; Kim, Woo-shik; Woo, Jong Shin; Lee, Sanghoon; Kim, Jin-Bae; Kim, Weon

    2015-01-01

    Background. Atrial fibrillation (AF) is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF). Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1?:?1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA) and left atrial appendage (LAA) changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs) of Kyung Hee University Hospital (number 1335-04). This trial is registered with clinicaltrials.gov NCT02110537. PMID:25784948

  12. Acupuncture at local and distant points for tinnitus: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Tinnitus is the perception of a sound in the absence of an objective physical source. Up to now, there is no generally accepted view how these phantom sounds come about, and also no efficient treatment. Patients are turning to complementary or alternative medical therapies, such as acupuncture. Based on the theory of traditional Chinese medicine, acupoints located on both the adjacent and distal area of the disease can be needled to treat disease. Furthermore, the way of combining acupoints is for strengthening the curative effect. We aim to evaluate the efficacy of acupuncture at local points in combination with distal points in subjective tinnitus patients. Method This trial is a randomized, single-blind, controlled study. A total of 112 participants will be randomly assigned to one of four treatment groups receiving acupuncture treatment for 4 weeks. The primary outcome measure is subjective tinnitus loudness and annoyance perception, which is graded using the Visual Analogue Scale (VAS). The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion Completion of this trial will help to identify whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN29230777 PMID:23176350

  13. Patient advocates' role in clinical trials: Perspectives from Cancer and Leukemia Group B investigators and advocates. | accrualnet.cancer.gov

    Cancer.gov

    Although there is a call for increased involvement of patient advocates in the design of clinical trials and patient recruitment and awareness efforts, little is known about the role and impact of patient advocates. A cooperative group survey of advocates and investigators forms the basis for recommendations.

  14. Brief Group Intervention Using Emotional Freedom Techniques for Depression in College Students: A Randomized Controlled Trial

    PubMed Central

    Church, Dawson; De Asis, Midanelle A.; Brooks, Audrey J.

    2012-01-01

    Two hundred thirty-eight first-year college students were assessed using the Beck Depression Inventory (BDI). Thirty students meeting the BDI criteria for moderate to severe depression were randomly assigned to either a treatment or control group. The treatment group received four 90-minute group sessions of EFT (Emotional Freedom Techniques), a novel treatment that combines exposure, cognitive reprocessing, and somatic stimulation. The control group received no treatment. Posttests were conducted 3 weeks later on those that completed all requirements (N = 18). The EFT group (n = 9) had significantly more depression at baseline than the control group (n = 9) (EFT BDI mean = 23.44, SD = 2.1 versus control BDI mean = 20.33, SD = 2.1). After controlling for baseline BDI score, the EFT group had significantly less depression than the control group at posttest, with a mean score in the “nondepressed” range (P = .001; EFT BDI mean = 6.08, SE = 1.8 versus control BDI mean = 18.04, SE = 1.8). Cohen's d was 2.28, indicating a very strong effect size. These results are consistent with those noted in other studies of EFT that included an assessment for depression and indicate the clinical usefulness of EFT as a brief, cost-effective, and efficacious treatment. PMID:22848802

  15. Medicare Clinical Trial Policy Phase I and Phase II Studies

    Cancer.gov

    National Cancer Institute National Cancer Institute Clinical Trials Advisory Committee (CTAC) Meeting Clinical Trials Advisory Committee (CTAC) Meeting December 8, 2008 December 8, 2008 Leslye K. Fitterman, PhD Leslye K.

  16. Safety Monitoring in Group A Meningococcal Conjugate Vaccine Trials: Description, Challenges, and Lessons

    PubMed Central

    Enwere, Godwin C.; Paranjape, Gandhali; Kulkarni, Prasad S.; Ginde, Manisha; Hartmann, Katharina; Viviani, Simonetta; Chaumont, Julie; Martellet, Lionel; Makadi, Marie-Francoise; Ivinson, Karen; Marchetti, Elisa; Herve, Jacques; Kertson, Kim; LaForce, F. Marc; Preziosi, Marie-Pierre

    2015-01-01

    Background.?The determination of the safety profile of any vaccine is critical to its widespread use in any population. In addition, the application of international guidelines to fit local context could be a challenging but important step toward obtaining quality safety data. Methods.?In clinical studies of PsA-TT (MenAfriVac), safety was monitored immediately after vaccination, at 4–7 days for postimmunization local and systemic reactions, within 28 days for adverse events, and throughout the duration of study for serious adverse events. Initial and ongoing training of sites' staff were undertaken during the studies, and a data and safety monitoring board reviewed all the data during and after the studies. Results.?The safety of PsA-TT was evaluated according to international standards despite obvious challenges in remote areas where these studies were conducted. These challenges included the need for uniformity of methods, timely reporting in the context of frequent communication problems, occurrence of seasonal diseases such as malaria and rotavirus diarrhea, and healthcare systems that required improvement. Conclusions.?The trials of PsA-TT highlighted the value of a robust vaccine development plan and design so that lessons learned in initial studies were incorporated into the subsequent ones, initial training and periodic retraining, strict monitoring of all procedures, and continuous channel of communication with all stakeholders that enabled the application of international requirements to local settings, with high quality of data. PMID:26553681

  17. Household obesity prevention: Take Action--a group-randomized trial. — Measures of the Food Environment

    Cancer.gov

    The purpose of the present study was to evaluate an intervention to prevent weight gain among households (HHs) in the community. Ninety HHs were randomized to intervention or control group for 1 year. Intervention consisted of six face-to-face group sessions, placement of a television (TV) locking device on all home TVs, and home-based intervention activities. Measures were collected in person at baseline and 1 year.

  18. Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

    PubMed Central

    Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

    2015-01-01

    Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID:25972803

  19. Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet. Methods/Design A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer. The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol. Discussion Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer. Trial registration German Clinical Trial Register Number: DRKS00000040 PMID:21303515

  20. Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study. Methods/design This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about acupuncture, and adverse events. Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy. Discussion Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms. If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009. PMID:24925094

  1. International Lead and Zinc Study Group

    E-print Network

    Laughlin, Robert B.

    International Lead and Zinc Study Group 38 Rua Almirante Barroso 5th Floor Lisbon 1000-013 Portugal Tel: +351 21 359 24 20 Fax: +351 21 359 24 29 Web Site: www.ilzsg.org E-Mail: root@ilzsg.org LEAD AND ZINC STATISTICS Monthly bulletin of the International Lead and Zinc Study Group Vol 46 No 2 FEBRUARY

  2. LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ?34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. Methods/design This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ?34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. Trial registration ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). PMID:25027230

  3. Generalizing from Clinical Trial Data: A Case Study. The Risk of Suicidality Among Pediatric Antidepressant Users

    E-print Network

    Antidepressant Users Running Title: Generalizing from Clinical Trial Data: A Case Study Authors: Joel B reason: to make data from the trials clearer and thus to make safety and efficacy testing more efficient of suicidality among pediatric antidepressant users. 1. Introduction Randomized clinical trials (RCTs

  4. Doing Anger Differently: two controlled trials of percussion group psychotherapy for adolescent reactive aggression.

    PubMed

    Currie, Michael; Startup, Mike

    2012-08-01

    This study evaluates efficacy and effectiveness of 'Doing Anger Differently' (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1, but also followed up controls at 6 months. In study 1 (N = 54) the treatment resulted in lowered trait anger (Cohen's d = -1.3), aggression-reports (d = -1.0) and depression (d = -0.6), and increased self-esteem (d = 0.6), all maintained at six months. In study 2 (N = 65), aggression-reports fell to one fifth of pre-treatment levels at nine months follow-up (d = -1.2), with lowered trait anger (d = -0.4) and anger expression (d = -0.3) post-treatment. PMID:22245455

  5. Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

    SciTech Connect

    Rodrigues, George; Bae, Kyounghwa; Roach, Mack; Lawton, Colleen; Donnelly, Bryan; Grignon, David; Hanks, Gerald; Porter, Arthur; Lepor, Herbert; Sandler, Howard

    2011-06-01

    Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

  6. Who Enrolls Onto Clinical Oncology Trials? A Radiation Patterns of Care Study Analysis

    SciTech Connect

    Movsas, Benjamin . E-mail: bmovsas1@hfhs.org; Moughan, Jennifer; Owen, Jean; Coia, Lawrence R.; Zelefsky, Michael J.; Hanks, Gerald; Wilson, J. Frank

    2007-07-15

    Purpose: To identify factors significantly influencing accrual to clinical protocols by analyzing radiation Patterns of Care Study (PCS) surveys of 3,047 randomly selected radiotherapy (RT) patients. Methods and Materials: Patterns of Care Study surveys from disease sites studied for the periods 1992-1994 and 1996-1999 (breast cancer, n = 1,080; prostate cancer, n = 1,149; esophageal cancer, n = 818) were analyzed. The PCS is a National Cancer Institute-funded national survey of randomly selected RT institutions in the United States. Patients with nonmetastatic disease who received RT as definitive or adjuvant therapy were randomly selected from eligible patients at each institution. To determine national estimates, individual patient records were weighted by the relative contribution of each institution and patients within each institution. Data regarding participation in clinical trials were recorded. The factors age, gender, race, type of insurance, and practice type of treating institution (academic or not) were studied by univariate and multivariate analyses. Results: Overall, only 2.7% of all patients were accrued to clinical protocols. Of these, 57% were enrolled on institutional review board-approved institutional trials, and 43% on National Cancer Institute collaborative group studies. On multivariate analysis, patients treated at academic facilities (p = 0.0001) and white patients (vs. African Americans, p = 0.0002) were significantly more likely to participate in clinical oncology trials. Age, gender, type of cancer, and type of insurance were not predictive. Conclusions: Practice type and race significantly influence enrollment onto clinical oncology trials. This suggests that increased communication and education regarding protocols, particularly focusing on physicians in nonacademic settings and minority patients, will be essential to enhance accrual.

  7. Predictors of accrual success for cooperative group trials: The Cancer and Leukemia Group B (Alliance) experience. | accrualnet.cancer.gov

    Cancer.gov

    Gordon DH,Liu Q,Kleinman B,Karrison T,Kelly M,Fleming GF. Alliance for Clinical Trials in Oncology, Chicago, IL; University of Chicago, Chicago, IL. ASCO 2013 Annual Meeting. 2013 May 31. 2013 Jun 04. Chicago, IL.

  8. An experimental and trial study on the second- generation MSTP

    NASA Astrophysics Data System (ADS)

    Xiao, Xiaojun; Yang, Liu; Zuo, Jian

    2004-04-01

    With the explosive growth of data services, SDH/SONET network, which is designed for voice traffic, is required to be optimized for data services. SDH-based Multi-Service Transport Platform (MSTP), which greatly improves the data capabilities of SDH networks, has been attracting much interest of vendors as well as network operators. As a leading operator in China, we have conducted a field trial study and extensive experiments on MSTP. In this paper, we present the results of our experiments. It is verified via extensive experiments that the products from some leading vendors conform to the standards. In addition, it is shown that the performance of the new value-added metro Ethernet services is highly satisfied, i.e., with tight QOS guarantees and flexible bandwidth that fits the user"s requirement exactly. We have also performed experiments for multi-vendors interoperability, and the results are highly satisfied, paving the way for large scale deployment of 2G MSTP. Our trial work showed MSTP can be used to optimize the existing metro networks, i.e., to improve the utilization of the fiber and the bandwidth that are used to carry the ADSL traffic and the IP traffic. In addition, MSTP presents a new array of opportunities for operators to increase their revenues.

  9. The SHED-IT community trial study protocol: a randomised controlled trial of weight loss programs for overweight and obese men

    PubMed Central

    2010-01-01

    Background Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men. Methods and Design The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2); no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology) study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II) and randomised to one of three groups: (1) SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure) with embedded behaviour change strategies to support weight loss; (2) SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3) Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome), % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary intake, sedentary behaviour, physical activity and dietary cognitions, sleepiness, quality of life, and perceived sexual health. Generalised linear mixed models will be used to assess all outcomes for the impact of group (Resources, Online, and Control), time (treated as categorical with levels baseline, 3-months and 6-months) and the group-by-time interaction. These three terms will form the base model. 'Intention-to-treat' analysis will include all randomised participants. Discussion Our study will compare evidence-based and theoretically driven, low cost and easily disseminated strategies specifically targeting weight loss in men. The SHED-IT community trial will provide evidence to inform development and dissemination of sustainable strategies to reduce obesity in men. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN12610000699066) PMID:21078200

  10. An Open Trial Investigation of a Transdiagnostic Group Treatment for Children with Anxiety and Depressive Symptoms

    ERIC Educational Resources Information Center

    Bilek, Emily L.; Ehrenreich-May, Jill

    2012-01-01

    The current study investigates the feasibility and preliminary outcomes associated with a transdiagnostic emotion-focused group protocol for the treatment of anxiety disorders and depressive symptoms in youth. Twenty-two children (ages 7 to 12; M = 9.79) with a principal anxiety disorder and varying levels of comorbid depressive symptoms were…

  11. Can Group Interventions Facilitate Forgiveness of an Ex-Spouse?: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Rye, Mark S.; Pargament, Kenneth I.; Pan, Wei; Yingling, David W.; Shogren, Karrie A.; Ito, Masako

    2005-01-01

    This study evaluated the effectiveness of 2 versions of an 8-session forgiveness group intervention for divorced individuals. Participants (randomized, n = 192; analyzed, n = 149) were randomly assigned to a secular forgiveness condition, a religious forgiveness condition, or a no-intervention comparison condition. Measures of forgiveness and…

  12. Mindfulness and Acceptance-Based Group Therapy for Social Anxiety Disorder: An Open Trial

    ERIC Educational Resources Information Center

    Kocovski, Nancy L.; Fleming, Jan E.; Rector, Neil A.

    2009-01-01

    Mindfulness and Acceptance-Based Group Therapy (MAGT) for Social Anxiety Disorder (SAD) is based largely on Acceptance and Commitment Therapy (ACT; Hayes et al., 1999), with enhanced mindfulness mostly from Mindfulness-Based Cognitive Therapy (MBCT; Segal et al., 2002). The purpose of this study was to assess the feasibility and initial…

  13. Mental skills training with basic combat training soldiers: A group-randomized trial.

    PubMed

    Adler, Amy B; Bliese, Paul D; Pickering, Michael A; Hammermeister, Jon; Williams, Jason; Harada, Coreen; Csoka, Louis; Holliday, Bernie; Ohlson, Carl

    2015-11-01

    Cognitive skills training has been linked to greater skills, self-efficacy, and performance. Although research in a variety of organizational settings has demonstrated training efficacy, few studies have assessed cognitive skills training using rigorous, longitudinal, randomized trials with active controls. The present study examined cognitive skills training in a high-risk occupation by randomizing 48 platoons (N = 2,432 soldiers) in basic combat training to either (a) mental skills training or (b) an active comparison condition (military history). Surveys were conducted at baseline and 3 times across the 10-week course. Multilevel mixed-effects models revealed that soldiers in the mental skills training condition reported greater use of a range of cognitive skills and increased confidence relative to those in the control condition. Soldiers in the mental skills training condition also performed better on obstacle course events, rappelling, physical fitness, and initial weapons qualification scores, although effects were generally moderated by gender and previous experience. Overall, effects were small; however, given the rigor of the design, the findings clearly contribute to the broader literature by providing supporting evidence that cognitive training skills can enhance performance in occupational and sports settings. Future research should address gender and experience to determine the need for targeting such training appropriately. (PsycINFO Database Record PMID:26011718

  14. Facebook Groups as LMS: A Case Study

    ERIC Educational Resources Information Center

    Meishar-Tal, Hagit; Kurtz, Gila; Pieterse, Efrat

    2012-01-01

    This paper describes a pilot study in using Facebook as an alternative to a learning management system (LMS). The paper reviews the current research on the use of Facebook in academia and analyzes the differences between a Facebook group and a regular LMS. The paper reports on a precedent-setting attempt to use a Facebook group as a course…

  15. Effective Group Training for Patients with Unexplained Physical Symptoms: A Randomized Controlled Trial with a Non-Randomized One-Year Follow-Up

    PubMed Central

    Zonneveld, Lyonne N. L.; van Rood, Yanda R.; Timman, Reinier; Kooiman, Cornelis G.; van't Spijker, Adriaan; Busschbach, Jan J. V.

    2012-01-01

    Background Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. Methodology/Principal Findings The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d?=?0.38;p?=?.002), but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d?=?0.43;p?=?0.01), emotional (Cohen's d?=?0.44;p?=?.0.01), and social (Cohen's d?=?0.36;p?=?0.01) functioning, less pain and better functioning despite pain (Cohen's d?=?0.51;p?=?<0.001), less physical symptoms (Cohen's d?=??.23;p?=?0.05) and less sleep difficulties (Cohen's d?=??0.25;p?=?0.04) than time in the waiting group. During the non-randomized follow-ups, there were no relapses. Conclusions/Significance The cognitive-behavioral group training tailored for UPS in primary care and provided by an outreaching secondary mental-health service appears to be effective and to broaden the accessibility of treatment for UPS. Trial Registration TrialRegister.nl NTR1609 PMID:22880056

  16. Improving hypertension control among excessive alcohol drinkers: a randomised controlled trial in France. The WALPA Group.

    PubMed Central

    Lang, T; Nicaud, V; Darné, B; Rueff, B

    1995-01-01

    OBJECTIVES--To improve blood pressure control among hypertensive ( > 140/90 mmHg) excessive alcohol drinkers. DESIGN--Fourteen worksite physicians were randomised onto an intervention group and a control group. The intervention was based on training the worksite physicians and follow up of those hypertensive subjects defined as excessive drinkers. Follow up was based on self monitoring of alcohol consumption by the subject, in view of the results of their gamma glutamyl transferase (GGT) activity determination. SETTING--Fourteen workplaces in France - mainly in the industrial sector. SUBJECTS--Altogether 15 301 subjects were screened by the 14 physicians: 129 of these were included in the study. MAIN OUTCOME MEASURES--This was the difference between the initial systolic blood pressure (SBP) and the SBP one year later (delta BP). Secondary criteria were the difference between the initial and final diastolic blood pressure (delta DBP) and delta BP at two years; antihypertensive treatment; state alcohol consumption (delta AC); delta GGT; and body mass index (delta BMI). RESULTS--The decrease in SBP levels was significantly larger in the intervention group than in the control group: at one year, delta SBP values were -11.9 (15.6) mmHg and -4.6 (13.8) respectively (p < 0.05). This benefit was still observed after two years of follow up (-13.8 (17.4) mmHg v -7.5 (14.2) mmHg (p < 0.05)). No difference was observed in DBP. The percentage of treated subjects did not differ between groups. At one year, delta AC was larger in the intervention group (-2.8 (5.2) U/d) than in the control group (-1.6 (3.4) (p < 0.1)). delta GGT and delta BMI did not differ between the two groups. A weak positive correlation was observed between delta AC and delta SBP (r = 0.16). CONCLUSION--An intervention aimed at the hypertensive excessive drinkers in a working population was found to be effective in reducing SBP on a long term basis (two years). The mechanisms of reduction in alcohol consumption and improved drug compliance cannot be ascertained in this pragmatic study. From a public health point of view, reducing the excess cardiovascular risk among a "hard to reach" population seems feasible with a strategy specifically designed for this high risk group. PMID:8596098

  17. Motivationally enhanced group counseling for substance users in a soup kitchen: a randomized clinical trial.

    PubMed

    Rosenblum, Andrew; Magura, Stephen; Kayman, Deborah J; Fong, Chunki

    2005-10-01

    Soup kitchens tend to serve residentially unstable adults characterized by a high prevalence of substance abuse. In this study, 289 soup kitchen guests who reported drug or alcohol problems were randomly assigned to information and referral (I&R) plus peer advocacy (peers encouraging subjects to participate in other services) (N = 139) or to an experimental 12-session motivational group (three sessions per week for 4 weeks) followed by a 36-session cognitive-behavioral group (three sessions per week for 12 weeks), plus I&R and peer advocacy. Mean age was 42; 82% male; 68% African-American; 81% unstable residence; 14% HIV+. Experimentals were significantly more likely than the controls to have increased their participation in some type of substance abuse intervention during the follow-up period. In addition, experimentals were significantly more likely than controls to have reduced both drinking and heavy drinking at follow-up (there was no difference between groups in reduction of cocaine use). Interaction analysis indicated that the experimental intervention was more effective for participants with higher rather than lower substance abuse severity at baseline. These results support the concept that motivationally enhanced group counseling, provided as a low-threshold outreach intervention, can help to increase participation in formal treatment and 12-step groups and to reduce substance abuse, particularly for those starting with high severity of use. PMID:16157232

  18. Weight change in control group participants in behavioural weight loss interventions: a systematic review and meta-regression study

    PubMed Central

    2012-01-01

    Background Unanticipated control group improvements have been observed in intervention trials targeting various health behaviours. This phenomenon has not been studied in the context of behavioural weight loss intervention trials. The purpose of this study is to conduct a systematic review and meta-regression of behavioural weight loss interventions to quantify control group weight change, and relate the size of this effect to specific trial and sample characteristics. Methods Database searches identified reports of intervention trials meeting the inclusion criteria. Data on control group weight change and possible explanatory factors were abstracted and analysed descriptively and quantitatively. Results 85 trials were reviewed and 72 were included in the meta-regression. While there was no change in control group weight, control groups receiving usual care lost 1 kg more than control groups that received no intervention, beyond measurement. Conclusions There are several possible explanations why control group changes occur in intervention trials targeting other behaviours, but not for weight loss. Control group participation may prevent weight gain, although more research is needed to confirm this hypothesis. PMID:22873682

  19. Harnessing technology to enhance delivery of clinical trials education for nurses: a report from the Children's Oncology Group.

    PubMed

    Haugen, Maureen; Gasber, Eric; Leonard, Marcia; Landier, Wendy

    2015-01-01

    The challenge of providing high-quality, relevant, time-sensitive continuing nursing education is particularly salient in pediatric oncology, where nurses commonly deliver complex protocol-based care to children enrolled on clinical trials. The Children's Oncology Group Nursing Discipline developed Portable Document Format multimedia modules to make a broad range of educational content regarding pediatric oncology clinical trials available to its membership. This time-sensitive educational content is accessible to nurses via asynchronous online education. To assess awareness of and user experience with the multimedia modules, a survey was conducted of nurses attending a Children's Oncology Group meeting. Over half (57%) of nurses were aware of the modules and half of those (51%) had viewed at least 1 module. Over 90% of nurses who viewed the modules were satisfied or very satisfied with the viewing experience; nurses younger than age 40 were 4 times more likely to be unaware of the modules than were older nurses (P = .007). PMID:25612836

  20. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

    PubMed Central

    2014-01-01

    Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months (pre-intervention), 9, 15, and 21 months. Discussion We know of no previous study that has evaluated an intervention that combines the capacity of nurse and internet-based services to improve outcomes for mothers and infants. The knowledge gained from this study will inform the design and conduct of community-based postnatal mother and child support programs. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000204741 PMID:24886238

  1. Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial

    PubMed Central

    2013-01-01

    Background In the UK, 40% of Bangladeshi and 29% of Pakistani men smoke cigarettes regularly compared to the national average of 24%. As a consequence, second-hand smoking is also widespread in their households which is a serious health hazard to non-smokers, especially children. Smoking restrictions in households can help reduce exposure to second-hand smoking. This is a pilot trial of ‘Smoke Free Homes’, an educational programme which has been adapted for use by Muslim faith leaders, in an attempt to find an innovative solution to encourage Pakistani- and Bangladeshi-origin communities to implement smoking restrictions in their homes. The primary objectives for this pilot trial are to establish the feasibility of conducting such an evaluation and provide information to inform the design of a future definitive study. Methods/Design This is a pilot cluster randomised controlled trial of ‘Smoke Free Homes’, with an embedded preliminary health economic evaluation and a qualitative analysis. The trial will be carried out in around 14 Islamic religious settings. Equal randomisation will be employed to allocate each cluster to a trial arm. The intervention group will be offered the Smoke Free Homes package (Smoke Free Homes: a resource for Muslim religious teachers), trained in its use, and will subsequently implement the package in their religious settings. The remaining clusters will not be offered the package until the completion of the study and will form the control group. At each cluster, we aim to recruit around 50 households with at least one adult resident who smokes tobacco and at least one child or a non-smoking adult. Households will complete a household survey and a non-smoking individual will provide a saliva sample which will be tested for cotinine. All participant outcomes will be measured before and after the intervention period in both arms of the trial. In addition, a purposive sample of participants and religious leaders/teachers will take part in interviews and focus groups. Discussion The results of this pilot study will inform the protocol for a definitive trial. Trial registration Current Controlled Trials ISRCTN03035510 PMID:24034853

  2. Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Rozental, Alexander

    2013-01-01

    Background Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment period, albeit without therapist contact. Results The current study is believed to result in three important findings. First, a CBT intervention is assumed to be beneficial for people suffering from problems caused by procrastination. Second, the degree of therapist contact will have a positive effect on treatment outcome as procrastination can be partially explained as a self-regulatory failure. Third, an Internet based CBT intervention is presumed to be an effective way to administer treatment for procrastination, which is considered highly important, as the availability of adequate care is limited. The current study is therefore believed to render significant knowledge on the treatment of procrastination, as well as providing support for the use of Internet based CBT for difficulties due to delayed tasks and commitments. Conclusions To our knowledge, the current study is the first clinical trial to examine the effects of CBT for procrastination, and is assumed to render significant knowledge on the treatment of procrastination, as well as investigating whether it can be delivered via the Internet. Trial Registration ClinicalTrials.gov: NCT01842945; http://clinicaltrials.gov/show/NCT01842945 (Archived by WebCite at http://www.webcitation.org/6KSmaXewC). PMID:24220277

  3. Congestive heart failure adherence redesign trial: a pilot study

    PubMed Central

    Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

    2014-01-01

    Objective Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. Setting A large tertiary care medical centre in Chicago. Participants Low-income patients (study. Interventions Physicians received HF guidelines and periodic individualised feedback on their adherence to EBT. Patients received HF education, support and self-management training for diet and medication adherence by a trained nurse through 11 interactive sessions over a 4-month period. Evaluations were conducted pre-enrolment and 1?month postintervention completion. Outcome measures Feasibility was assessed by the ability to deliver intervention to patients and physicians. Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians. Results Eighty-seven per cent and 82% of patients received >80% of interventions at 1?month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0?g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. Conclusions This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. PMID:25475245

  4. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial

    PubMed Central

    Vesco, Kimberly K.; Karanja, Njeri; King, Janet C.; Gillman, Matthew W.; Leo, Michael C.; Perrin, Nancy; McEvoy, Cindy T.; Eckhardt, Cara L.; Smith, K. Sabina; Stevens, Victor J.

    2014-01-01

    Objective Observational studies suggest that minimal gestational weight gain (GWG) may optimize pregnancy outcomes for obese women. This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women. Methods We randomized 114 obese women (BMI [mean±SD] 36.7±4.9 kg/m2) between 7–21 weeks’ (14.9±2.6) gestation to intervention (n=56) or usual care control conditions (n=58). The intervention included individualized calorie goals, advice to maintain weight within 3% of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction, and attendance at weekly group meetings until delivery. Control participants received one-time dietary advice. Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation, and newborn large-for-gestational age (birth weight >90th percentile, LGA). Results Intervention participants gained less weight from randomization to 34 weeks gestation (5.0 vs 8.4 kg, mean difference=?3.4 kg, 95% CI [?5.1, ?1.8]), and from randomization to 2 weeks postpartum (?2.6 vs +1.2 kg, mean difference=?3.8 kg, 95% CI [?5.9, ?1.7]). They also had a lower proportion of LGA babies (9% vs. 26%, odds ratio=0.28, 95% CI [0.09, 0.84]). Conclusions The intervention resulted in lower GWG and lower prevalence of LGA newborns. PMID:25164259

  5. Therapeutic research in low-income countries: studying trial communities.

    PubMed

    Whyte, Susan Reynolds

    2014-11-01

    Social scientists undertaking studies of transnational medical research in developing countries focus on 'trial communities': networks of funders, institutions, researchers, clinical staff, fieldworkers and study participants. They relate these to the political economy that brings powerful research resources to poor settings. Whereas bioethicists tend to consider universal ethical requirements, social scientists examine how ethics are practiced in given situations in the light of the concerns and interests held by different parties involved in medical research. In conditions of poverty, high morbidity and weak public health services, research subjects are heavily induced by the prospect of high quality medical care and other benefits that researchers seem to offer. Studies of medical research undertaken by well-established internationally funded institutions in Africa show that parents are keen to have their children 'join' projects at these organisations. They assess benefits and risks less in terms of specific research projects and more in terms of their overall trust in the care these institutions are known to have provided previously for others in the community. Bioethics should widen its scope beyond concern with protecting individual subjects from the risks of specific research projects. It should recognise that clinical and research functions are indistinguishable for many participants, who want information on results of clinical investigations and sustained support for improving the health of their children. PMID:24748638

  6. 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 ...

  7. 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 can provide a translational model for community use. It can also be utilized as such or tailored to other selected populations or age groups. Trial registration ClinicalTrials.gov Identifier: NCT01376986 PMID:23311678

  8. Quality control in multicentric clinical trials. An experience of the EORTC Gynecological Cancer Cooperative Group. | accrualnet.cancer.gov

    Cancer.gov

    The authors conducted a data quality study for a European Organization for Research and Treatment of Cancer (EORTC) multicenter randomized phase III treatment trial focusing on cervical cancer. Analysis of the causes of inaccuracies revealed problems in data management, but the investigators also associated some errors with lack of clarity in the protocol and case report forms (CRFs).

  9. Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study

    PubMed Central

    Newman, Peter A.; Rubincam, Clara; Slack, Catherine; Essack, Zaynab; Chakrapani, Venkatesan; Chuang, Deng-Min; Tepjan, Suchon; Shunmugam, Murali; Roungprakhon, Surachet; Logie, Carmen; Koen, Jennifer; Lindegger, Graham

    2015-01-01

    Objectives Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations. Methods From 2008–2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement. Results Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of “community”; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted. Conclusions This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making. PMID:26295159

  10. Manage at work: a randomized, controlled trial of a self-management group intervention to overcome workplace challenges associated with chronic physical health conditions

    PubMed Central

    2014-01-01

    Background The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries, but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions. While most workers are eligible for job accommodation and disability compensation benefits, other workplace strategies might improve individual-level coping and problem solving to prevent work disability. In this study, we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders. Methods In a randomized controlled trial (RCT), workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment (wait list) control condition. Volunteer employees (n?=?300) will be recruited from five participating employers and randomly assigned to intervention or control. Participants in the intervention arm will attend facilitated group workshop sessions at work (10 hours total) to explore methods for improving comfort, adjusting work habits, communicating needs effectively, applying systematic problem solving, and dealing with negative thoughts and emotions about work. Work engagement and work limitation are the principal outcomes. Secondary outcomes include fatigue, job satisfaction, self-efficacy, turnover intention, sickness absence, and health care utilization. Measurements will be taken at baseline, 6-, and 12-month follow-up. A process evaluation will be performed alongside the randomized trial. Discussion This study will be most relevant for organizations and occupational settings where some degree of job flexibility, leeway, and decision-making autonomy can be afforded to affected workers. The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness. Trial registration Clinicaltrials.gov: NCT01978392 (Issued November 6, 2013) PMID:24885844

  11. A Controlled Trial of Active versus Passive Learning Strategies in a Large Group Setting

    ERIC Educational Resources Information Center

    Haidet, Paul; Morgan, Robert O.; O'Malley, Kimberly; Moran, Betty Jeanne; Richards, Boyd F.

    2004-01-01

    Objective: To compare the effects of active and didactic teaching strategies on learning- and process-oriented outcomes. Design: Controlled trial. Setting: After-hours residents' teaching session. Participants: Family and Community Medicine, Internal Medicine, and Pediatrics residents at two academic medical institutions. Interventions: We…

  12. Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis—the PMEP trial: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The prevalence of methicillin-resistant Staphylococcus aureus (MRSA) respiratory infection in cystic fibrosis (CF) has increased dramatically over the last decade, and is now affecting approximately 25% of patients. Epidemiologic evidence suggests that persistent infection with MRSA results in an increased rate of decline in FEV1 and shortened survival. Currently, there are no conclusive studies demonstrating an effective and safe treatment protocol for persistent MRSA respiratory infection in CF. Methods/Design The primary objective of this study is to evaluate the safety and efficacy of a 28-day course of vancomycin for inhalation in combination with oral antibiotics in eliminating MRSA from the respiratory tract of individuals with CF and persistent MRSA infection. This is a two-center, randomized, double-blind, comparator-controlled, parallel-group study with 1:1 assignment to either vancomycin for inhalation (250 mg twice a day) or taste-matched placebo for 28 days in individuals with cystic fibrosis. In addition, both groups will receive oral rifampin, a second oral antibiotic – trimethoprim/sulfamethoxazole (TMP/SMX) or doxycycline, protocol determined – mupirocin intranasal cream, and chlorhexidine body washes. Forty patients with persistent respiratory tract MRSA infection will be enrolled: 20 will be randomized to vancomycin for inhalation and 20 to a taste-matched placebo. The primary outcome will be the presence of MRSA in sputum respiratory tract cultures 1 month after the conclusion of treatment. Secondary outcomes include the efficacy of the intervention on: FEV1% predicted, patient reported outcomes, pulmonary exacerbations, and MRSA colony-forming units found in respiratory tract sample culture. Discussion Results of this study will provide guidance to clinicians regarding the safety and effectiveness of a targeted eradication strategy for persistent MRSA infection in CF. Trial registration This trial is registered at ClinicalTrials.gov (NCT01594827, received 05/07/2012) and is funded by the Cystic Fibrosis Foundation (Grants: PMEP10K1 and PMEP11K1). PMID:24925006

  13. Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study

    PubMed Central

    2014-01-01

    Background Qualitative research is undertaken with randomized controlled trials of health interventions. Our aim was to explore the perceptions of researchers with experience of this endeavour to understand the added value of qualitative research to the trial in practice. Methods A telephone semi-structured interview study with 18 researchers with experience of undertaking the trial and/or the qualitative research. Results Interviewees described the added value of qualitative research for the trial, explaining how it solved problems at the pretrial stage, explained findings, and helped to increase the utility of the evidence generated by the trial. From the interviews, we identified three models of relationship of the qualitative research to the trial. In ‘the peripheral’ model, the trial was an opportunity to undertake qualitative research, with no intention that it would add value to the trial. In ‘the add-on’ model, the qualitative researcher understood the potential value of the qualitative research but it was viewed as a separate and complementary endeavour by the trial lead investigator and wider team. Interviewees described how this could limit the value of the qualitative research to the trial. Finally ‘the integral’ model played out in two ways. In ‘integral-in-theory’ studies, the lead investigator viewed the qualitative research as essential to the trial. However, in practice the qualitative research was under-resourced relative to the trial, potentially limiting its ability to add value to the trial. In ‘integral-in-practice’ studies, interviewees described how the qualitative research was planned from the beginning of the study, senior qualitative expertise was on the team from beginning to end, and staff and time were dedicated to the qualitative research. In these studies interviewees described the qualitative research adding value to the trial although this value was not necessarily visible beyond the original research team due to the challenges of publishing this research. Conclusions Health researchers combining qualitative research and trials viewed this practice as strengthening evaluative research. Teams viewing the qualitative research as essential to the trial, and resourcing it in practice, may have a better chance of delivering its added value to the trial. PMID:24913438

  14. The Counseling Older Adults to Control Hypertension (COACH) Trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults

    PubMed Central

    Ogedegbe, Gbenga; Fernandez, Senaida; Luerassi, Leanne; Silver, Stephanie A.; Kong, Jian; Midberry, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A.

    2013-01-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body weight; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination. PMID:23462343

  15. Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial

    PubMed Central

    2013-01-01

    Background Recovery after a major stroke is usually limited, but cell therapy for patients with fixed neurologic deficits is emerging. Several recent clinical trials have investigated mesenchymal stem cell (MSC) therapy for patients with ischemic stroke. We previously reported the results of a controlled trial on the application of autologous MSCs in patients with ischemic stroke with a long-term follow-up of up to 5 years (the 'STem cell Application Researches and Trials In NeuroloGy’ (STARTING) study). The results from this pilot trial are challenging, but also raise important issues. In addition, there have been recent efforts to improve the safety and efficacy of MSC therapy for stroke. Methods and design The clinical and preclinical background and the STARTING-2 study protocol are provided. The trial is a prospective, randomized, open-label, blinded-endpoint (PROBE) clinical trial. Both acute and chronic stroke patients will be selected based on clinical and radiological features and followed for 3 months after MSC treatment. The subjects will be randomized into one of two groups: (A) a MSC group (n = 40) or (B) a control group (n = 20). Autologous MSCs will be intravenously administered after ex vivo culture expansion with autologous ischemic serum obtained as early as possible, to enhance the therapeutic efficacy (ischemic preconditioning). Objective outcome measurements will be performed using multimodal MRI and detailed functional assessments by blinded observers. Discussion This trial is the first to evaluate the efficacy of MSCs in patients with ischemic stroke. The results may provide better evidence for the effectiveness of MSC therapy in patients with ischemic stroke. Trial registration This trial was registered with ClinicalTrials.gov, number NCT01716481. PMID:24083670

  16. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session. Clinical Trials Registry ClinicalTrials.gov, NCT01141608 http://clinicaltrials.gov/ct2/show/NCT01141608?term=Stimulant+Reduction+Intervention+using+Dosed+Exercise&rank=1 PMID:21929768

  17. Effect of a grade 6 HIV risk reduction intervention four years later among students who were and were not enrolled in the study trial

    PubMed Central

    Stanton, Bonita; Chen, Xinguang; Koci, Veronica; Deveaux, Lynette; Lunn, Sonja; Harris, Carole; Brathwaite, Nanika; Gomez, Perry; Li, Xiaoming; Marshall, Sharon

    2011-01-01

    Purpose To assess the long-term impact of HIV-prevention interventions delivered to youth before sexual initiation and the effects of interventions delivered in non-study settings. Methods A five-group comparison of HIV knowledge, and condom-use skills, self-efficacy, intentions and practice among 1997 grade 10 youth attending one of the eight government high schools in Nassau, The Bahamas. Group 1 received an HIV-prevention intervention, Focus on youth in the Caribbean (FOYC), in Grade 6 as part of a randomized trial; Group 2 received FOYC as part of the regular school curriculum but outside of the trial; Group 3 received the control condition as part of the trial; Group 4 received the control condition as part of the school curriculum but outside of the trial; and, Group 5 (Naïve Controls) were not enrolled in a school receiving FOYC or the control and did not participate in the trial. Results FOYC youth compared to control youth and Naive Controls had higher HIV knowledge, condom-use skills and self-efficacy four years later. By subgroups, Group 1 demonstrated higher HIV/AIDS knowledge than all groups except Group 2, higher condom skills than all groups, and higher condom self-efficacy than Naïve Controls. Youth in Group 2 demonstrated higher HIV knowledge than youth in Groups 3 to 5. Behavioral effects were not found. Conclusions FOYC delivered to grade 6 students continued to have protective effects four years later. Positive effects are present among youth who received FOYC as part of the school curriculum but were not enrolled in the trial. PMID:22325129

  18. Cancer patients' fears related to clinical trial participation: A qualitative study. | accrualnet.cancer.gov

    Cancer.gov

    This study determined that both the initial fear resulting from a cancer diagnosis and fears related to various aspects of clinical trials were barriers to clinical trial participation. However, a physician’s recommendation to participate was often the deciding factor for whether or not a patient participated in a clinical trial. This indicates that physicians must acknowledge patient fear in order to facilitate decision-making.

  19. Studying a disease with no home - lessons in trial recruitment from the PATCH II study

    PubMed Central

    2010-01-01

    Background Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This was the first trial to be undertaken by the UK Dermatology Clinical Trials Network. As such, it was the first to test a recruitment model that involved many busy clinicians each contributing just a few patients. Methods A double-blind randomised controlled trial comparing prophylactic antibiotics (penicillin V) with placebo tablets, for the prevention of repeat episodes of cellulitis of the leg. Primary outcome was time to subsequent recurrence of cellulitis. Results The PATCH II study was closed to recruitment having enrolled 123 participants from a target of 400. Whilst the recruitment period was extended by 12 months, it was not possible to continue beyond this point without additional funds. Many factors contributed to poor recruitment: (i) changes in hospital policy and the introduction of community-based intravenous teams resulted in fewer cellulitis patients being admitted to hospital; ii) those who were admitted were seen by many different specialties, making it difficult for a network of dermatology clinicians to identify suitable participants; and iii) funding for research staff was limited to a trial manager and a trial administrator at the co-ordinating centre. With no dedicated research nurses at the recruiting centres, it was extremely difficult to maintain momentum and interest in the study. Attempts to boost recruitment by providing some financial support for principal investigators to employ local research staff was of limited success. Discussion The model of a network of busy NHS clinicians all recruiting a few patients into large clinical studies requires further testing. It did not work very well for PATCH II, but this was probably because patients were not routinely seen by dermatologists, and recruitment took place prior to research support being available through the Comprehensive Clinical Research Network (CCRN). There is a balance to be struck between asking a lot of centres to recruit just a few patients, and asking a few centres to recruit a lot of patients. Giving modest funds to principal investigators to buy local research nurse time did not work well, probably because too little research time was bought, and it was difficult to separate research tasks from the nurses existing clinical duties. National research infrastructure networks such as the Comprehensive Clinical Research Network will overcome many of the problems encountered in the PATCH II trial. Trial Registration The trial registration number is ISRCTN03813200. PMID:20196846

  20. Group Music Intervention Reduces Aggression and Improves Self-esteem in Children with Highly Aggressive Behavior: A Pilot Controlled Trial.

    PubMed

    Choi, Ae-Na; Lee, Myeong Soo; Lee, Jung-Sook

    2010-06-01

    We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents), Child Aggression Assessment Inventory (Teachers) and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control. PMID:18955314

  1. Group Music Intervention Reduces Aggression and Improves Self-esteem in Children with Highly Aggressive Behavior: A Pilot Controlled Trial

    PubMed Central

    Lee, Myeong Soo; Lee, Jung-Sook

    2010-01-01

    We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents), Child Aggression Assessment Inventory (Teachers) and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control. PMID:18955314

  2. A minimally invasive technique for decompression of Chiari malformation type I (DECMI study): study protocol for a randomised controlled trial

    PubMed Central

    Hu, Yu; Liu, Jiagang; Chen, Haifeng; Jiang, Shu; Li, Qiang; Fang, Yuan; Gong, Shuhui; Wang, Yuelong; Huang, Siqing

    2015-01-01

    Introduction Chiari malformation type I (CM-I) is a congenital hindbrain anomaly that requires surgical decompression in symptomatic patients. Posterior fossa decompression with duraplasty (PFDD) has been widely practiced in Chiari decompression, but dural opening carries a high risk of surgical complications. A minimally invasive technique, dural splitting decompression (DSD), preserves the inner layer of the dura without dural opening and duraplasty, potentially reducing surgical complications, length of operative time and hospital stay, and cost. If DSD is non-inferior to PFDD in terms of clinical improvement, DSD could be an alternative treatment modality for CM-I. So far, no randomised study of surgical treatment of CM-I has been reported. This study aims to evaluate if DSD is an effective, safe and cost-saving treatment modality for adult CM-I patients, and may provide evidence for using the minimally invasive procedure extensively. Methods and analysis DECMI is a randomised controlled, single-masked, non-inferiority, single centre clinical trial. Participants meeting the criteria will be randomised to the DSD group and the PFDD group in a 1:1 ratio. The primary outcome is the rate of clinical improvement, which is defined as the complete resolution or partial improvement of the presenting symptoms/signs. The secondary outcomes consist of the incidence of syrinx reduction, postoperative morbidity rates, reoperation rate, quality of life (QoL) and healthcare resource utilisation. A total of 160 patients will be included and followed up at 3 and 12?months postoperatively. Ethics and dissemination The study protocol was approved by the Biological and Medical Ethics Committee of West China Hospital. The findings of this trial will be published in a peer-reviewed scientific journal and presented at scientific conferences. Trial registration number ChiCTR-TRC-14004099. PMID:25926152

  3. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in reduced recurrence rates following surgical treatment of early-stage oral cancer with significant impacts on survival, morbidity, patients' quality of life and the cost to the health care system. Trial Registration Clinicaltrials.gov NCT01039298 PMID:22026481

  4. Metacognition and Group Differences: A Comparative Study

    ERIC Educational Resources Information Center

    Al-Hilawani, Yasser A.

    2014-01-01

    In this study, metacognition refers to performing visual analysis and discrimination of real life events and situations in naïve psychology, naïve physics, and naïve biology domains. It is used, along with measuring reaction time, to examine differences in the ability of four groups of students to select appropriate pictures that correspond with…

  5. Report of the Public Cryptography Study Group.

    ERIC Educational Resources Information Center

    American Council on Education, Washington, DC.

    Concerns of the National Security Agency (NSA) that information contained in some articles about cryptography in learned and professional journals and in monographs might be inimical to the national security are addressed. The Public Cryptography Study Group, with one dissenting opinion, recommends that a voluntary system of prior review of…

  6. Acupuncture for dry eye syndrome after refractive surgery: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dry eye syndrome is a frequent complication of refractive surgery. Acupuncture has been widely used to alleviate the associated symptoms. However, the use of acupuncture for patients who suffer from dry eye syndrome following refractive surgery has certain drawbacks. This pilot study aims to evaluate the efficacy of acupuncture treatment in treating the signs and symptoms of dry eye syndrome after refractive surgery. Methods/design Forty participants will be randomly assigned to the acupuncture plus usual care group or the usual care control group. The acupuncture plus usual care group will undergo treatments on seventeen acupuncture points, three times per week for four weeks. The control group will receive only usual care during the same period. The primary outcomes will be scores on the Ocular Surface Disease Index (OSDI) and the results of examinations at 1, 3, 5, and 13 weeks. The secondary outcomes will be Tear Film Break-up Time (TBUT), as well as scores on the Schirmer-I test, visual analog scale (VAS), and quality of life (QOL) questionnaire for the self-assessment of ocular discomfort. Digital photographs will be taken to document the pattern of fluorescein staining observed on the corneal surface. The results of the Schirmer-I test, TBUT, and fluorescein-stained corneal surface digital photographs will be assessed at the screening and at week 13. VAS scores will be assessed at the screening, as well as at 1, 3, 5, and 13 weeks. QOL will be evaluated at 1, 3, 5, and 13 weeks. Discussion This trial will provide primary data with which to investigate the clinical effectiveness and safety of acupuncture treatment for dry eye syndrome after refractive surgery. Trial registration Current Controlled (Identifier: KCT0000727) PMID:24156469

  7. The effectiveness of integrated treatment in patients with substance use disorders co-occurring with anxiety and/or depression - a group randomized trial

    PubMed Central

    2014-01-01

    Background Integrated Treatment (IT) has proved effective in treating patients with Substance Use Disorders (SUD) co-occurring with severe Mental Disorders (MD), less is known about the effectiveness of IT for patients with SUD co-occurring with less severe MD. The aim of this study was to investigate the effectiveness of IT for patients with SUD co-occurring with anxiety and/or depression on the following parameters: 1. The use of substances, as measured by the Alcohol Use Identification Test (AUDIT), the Drug Use Identification Test (DUDIT), and the Addiction Severity Index (EuropASI). 2. The severity of psychiatric symptoms, as measured by the Symptom Check List 90 r (SCL 90R). 3. The client’s motivation for changing his/her substance use behaviour, as measured by the Substance Abuse Treatment Scale (SATSr). Methods This is a group randomized clinical trial comparing the effectiveness of IT to treatment as usual in Community Mental Health Centres (CMHCs). Five CMHCs were drawn to the Intervention Group (IG) and four CMHCs to the Control Group (CG). The allocation to treatment conditions was not blinded. New referrals were screened with the AUDIT and the DUDIT. Those who scored above the cut-off level of these instruments were assessed with the Structured Clinical Interview for DSM-IV 1 and 2. We included patients with anxiety and/or depression together with one or more SUDs. Results We included 55 patients in the IG and 21 in the CG. A linear multilevel model was used. Both groups reduced their alcohol and substance use during the trial, while there was no change in psychiatric symptoms in either group. However, the IG had a greater increase in motivation for substance use treatment after 12 months than had the CG with an estimate of 1.76, p = 0.043, CI95% (0.08; 3.44) (adjusted analyses). There were no adverse events. Conclusions Integrated treatment is effective in increasing the motivation for treatment amongst patients with anxiety and/or depression together with SUD in outpatient clinics. Trial registration ClinicalTrials.gov: NCT00447733. PMID:24597469

  8. Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial

    PubMed Central

    Nakagawa, Atsuo; Sado, Mitsuhiro; Mitsuda, Dai; Fujisawa, Daisuke; Kikuchi, Toshiaki; Abe, Takayuki; Sato, Yuji; Iwashita, Satoru; Mimura, Masaru; Ono, Yutaka

    2014-01-01

    Introduction Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. Methods and analysis The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65?years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16?weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients. Ethics and dissemination All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement. Trial registration number UMIN Clinical Trials Registry: UMIN000001218. PMID:25335963

  9. A physical education trial improves adolescents' cognitive performance and academic achievement: the EDUFIT study.

    PubMed

    Ardoy, D N; Fernández-Rodríguez, J M; Jiménez-Pavón, D; Castillo, R; Ruiz, J R; Ortega, F B

    2014-02-01

    To analyze the effects of an intervention focused on increasing the time and intensity of Physical Education (PE), on adolescents' cognitive performance and academic achievement. A 4-month group-randomized controlled trial was conducted in 67 adolescents from South-East Spain, 2007. Three classes were randomly allocated into control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). CG received usual PE (two sessions/week), EG1 received four PE sessions/week and EG2 received four PE sessions/week of high intensity. Cognitive performance (non-verbal and verbal ability, abstract reasoning, spatial ability, verbal reasoning and numerical ability) was assessed by the Spanish Overall and Factorial Intelligence Test, and academic achievement by school grades. All the cognitive performance variables, except verbal reasoning, increased more in EG2 than in CG (all P?study contributes to the current knowledge by suggesting that the intensity of PE sessions might play a role in the positive effect of physical activity on cognition and academic success. Future studies involving larger sample sizes should confirm or contrast these preliminary findings. PMID:23826633

  10. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups

    PubMed Central

    Jafar, Tazeen H.; Jehan, Imtiaz; Liang, Feng; Barbier, Sylvaine; Islam, Muhammad; Bux, Rasool; Khan, Aamir Hameed; Nadkarni, Nivedita; Poulter, Neil; Chaturvedi, Nish; Ebrahim, Shah

    2015-01-01

    Background Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE) and trained general practitioner (GP) intervention delivered over 2 years was more effective than no intervention (usual care) in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up. Methods A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE) were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes. Findings After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to those randomised to usual care, (P = 0.04). Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl. Conclusions The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These findings highlight the potential for scaling-up simple strategies for cardiovascular risk reduction in low- and middle- income countries. Trial Registration ClinicalTrials.gov NCT00327574 PMID:26540210

  11. Discrepancies between registration and publication of randomised controlled trials: an observational study

    PubMed Central

    Stevenson, Graham; Thornton, James G

    2014-01-01

    Summary Objectives To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs). Design An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data. Participants and Settings Data extracted from published RCTs in BMJ and JAMA. Main outcome measures Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size. Results We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers. Conclusions Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation’s argument for mandatory completion of a minimum number of compulsory fields. PMID:25057391

  12. Group trauma-informed treatment for adolescent psychiatric inpatients: a preliminary uncontrolled trial.

    PubMed

    Gudiño, Omar G; Weis, J Rebecca; Havens, Jennifer F; Biggs, Emily A; Diamond, Ursula N; Marr, Mollie; Jackson, Christie; Cloitre, Marylene

    2014-08-01

    Despite high rates of trauma exposure (46%-96%) and significant posttraumatic stress disorder (PTSD; 21%-29%) symptoms in adolescent psychiatric inpatients, there is a dearth of research on effective interventions delivered in inpatient settings. The current report describes the development of Brief STAIR-A, a repeatable 3-module version of skills training in affective and interpersonal regulation (STAIR) developed for adolescents in inpatient care. An uncontrolled design was used to conduct a preliminary examination of the group intervention's effectiveness. Adolescent psychiatric inpatients (N = 38; ages 12 years-17 years) admitted to a public hospital participated in Brief STAIR-A and attended a median of 6 sessions (range 3-36). They completed measures of PTSD and depressive symptom severity, coping skill use, and coping efficacy upon admission and again prior to discharge. Participants reported significant reductions in symptom severity (d = 0.65-0.67), no change in the absolute level of coping skills used (d = 0.16), but greater coping efficacy when discharged from care (d = 0.75). Results from this pilot study suggest that this brief group treatment shows promise for treating adolescents' trauma-related difficulties in inpatient psychiatry settings, but additional research examining its effectiveness is essential. PMID:25070927

  13. A new vaccine against tick-borne encephalitis: initial trial in man including a dose-response study.

    PubMed

    Bock, H L; Klockmann, U; Jüngst, C; Schindel-Künzel, F; Theobald, K; Zerban, R

    1990-02-01

    A new vaccine against tick-borne encephalitis was investigated in 56 healthy volunteers randomized for five different doses of antigen in a comparative group trial. Good tolerability and high immunogenicity were found using three different antibody test systems. The dose response study revealed that there was a strong relationship between the amount of antigen administered and the antibody response over the range of 0.03-3.0 micrograms antigen per dose. PMID:2316281

  14. Clinical Trials

    MedlinePLUS

    Clinical Trials What is a clinical trial? A clinical trial is a study carried out in human volunteers to help doctors learn more about the human body ... medicines and treatments. The information gained from a clinical study is added to the results from lab ...

  15. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong

    PubMed Central

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-01-01

    Introduction Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. Methods and analysis This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethics and dissemination Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Trial registration number Australian New Zealand Clinical Trial Registry (ACTRN)12613001120763. PMID:26443653

  16. Selenium supplementation for patients with Graves’ hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Graves’ hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmune hypothyroidism and on Graves' orbitopathy, but the effects of selenium on Graves' hyperthyroidism is unknown. We hypothesize that adjuvant selenium may be beneficial in the treatment of Graves' hyperthyroidism. The objective is to investigate if selenium supplementation plus standard treatment with anti-thyroid drugs versus standard treatment with anti-thyroid drugs will lead to a decrease in anti-thyroid drug treatment failure (that is, failure to remain euthyroid, without further treatment, one year after cessation of anti-thyroid drug treatment), faster and longer lasting remission (that is, anti-thyroid drug treatment success), and improved quality of life in patients with Graves’ hyperthyroidism. Methods and design The trial is an investigator-initiated, randomised, blinded, multicentre clinical trial. Inclusion criteria are: age 18 years or older; diagnosis of active Graves' hyperthyroidism within the last two months; and informed consent. Exclusion criteria are major co-morbidity; previous radioactive iodine treatment; ongoing anti-thyroid drug treatment for more than two months; treatment with immunomodulatory drugs; known allergy towards the components in the selenium and placebo pills; pregnancy or breast-feeding; and intake of selenium supplementation above 70 ?g per day. We plan to include 492 participants, randomised (1:1) to two tablets of 100 ?g selenium once daily for the 24 to 30 months intervention period versus two identical placebo tablets once daily. The primary outcome is the proportion of participants with anti-thyroid drug treatment failure (see above) at the end of the intervention period (24 to 30 months). Secondary outcomes are: thyroid-specific quality of life during the first year after randomisation; level of thyroid stimulating hormone-receptor antibodies at 18 months after randomisation and at the end of the intervention period (24 to 30 months); hyperthyroid symptoms during the first year after randomisation; eye symptoms during the first year after randomisation, and at the end of the intervention period (24 to 30 months); adverse reactions during the intervention period; and serious adverse events during the intervention period. Discussion It was of great importance to the initiators of this trial, that the results would be directly applicable to daily clinical practice. Therefore, it was designed as a pragmatic trial: the patients follow their usual treatment at their usual hospitals. In order to still collect high quality data on the clinical course and quality of life, an elaborate trial management system was designed to keep track of patient input, need for trial personnel input and action, and to collect data from medical chart systems. Meticulous follow-up on missing responses to the QoL measurements has been incorporated into the system, to minimise missing quality of life data. Monitoring of adverse reactions and events is achieved by thorough instruction of the participants, surveillance of patient-reported outcomes, and integration with national databases regarding hospitalizations. A very long intervention period was necessary, since patients are not considered in remission until one year after stopping anti-thyroid drugs. Usually, patients are treated for 12 to 18 months with anti-thyroid drugs, yielding a total intervention period of 24 to 30 months. Trial registration ClinicalTrials.gov: NCT01611896. PMID:23782950

  17. Different outcome of T cell acute lymphoblastic leukemia with translocation t(11;14) treated in two consecutive children leukemia group EORTC trials.

    PubMed

    Simon, Pauline; Suciu, Stefan; Clappier, Emmanuelle; Cave, Hélène; Sirvent, Nicolas; Plat, Geneviève; Thyss, Antoine; Mechinaud, Françoise; Costa, Vitor M; Ferster, Alina; Lutz, Patrick; Mazingue, Françoise; Plantaz, Dominique; Plouvier, Emmanuel; Bertrand, Yves; Benoit, Yves; Dastugue, Nicole; Rohrlich, Pierre S

    2016-01-01

    Acute lymphoblastic leukemia of T cell lineage (T-ALL) is an aggressive malignant disease which accounts for 15 % of childhood ALL. T(11;14) is the more frequent chromosomal abnormality in childhood T-ALL, but its prognostic value remained controversial. Our aim was to analyze the outcome of childhood T-ALL with t(11;14) to know if the presence of this translocation is associated with a poor prognosis. We conducted a retrospective study from a series of 20 patients with t(11;14), treated in two consecutive trials from the European Organization for Research and Treatment of Cancer Children Leukemia Group over a 19-year period from 1989 to 2008. There were no significant differences between the 2 consecutive groups of patients with t(11;14) regarding the clinical and biological features at diagnosis. Among 19 patients who reached complete remission, 9 patients relapsed. We noticed 7 deaths all relapse- or failure-related. In the 58881 study, a presence of t(11;14) was associated with a poor outcome with an event-free survival at 5 years at 22.2 % versus 65.1 % for the non-t(11;14) T-ALL (p?=?0.0004). In the more recent protocol, the outcome of T-ALL with t(11;14) reached that of non-t(11;14) T-ALL with an event-free survival at 5 years at 65.5 versus 74.9 % (p?=?0.93). The presence of t(11;14) appeared as a poor prognostic feature in the 58881 trial whereas this abnormality no longer affected the outcome in the 58951 study. This difference is probably explained by the more intensive chemotherapy in the latest trial. PMID:26455579

  18. Tobacco Cessation Treatment for Alaska Native Adolescents: Group Randomized Pilot Trial

    PubMed Central

    2014-01-01

    Introduction: Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and the potential efficacy of a targeted cessation intervention for AN youth using a group randomized design. Methods: Eight villages in western Alaska were randomly assigned to receive the intervention (n = 4 villages) or a delayed treatment control condition (written materials only; n = 4 villages). Ten adolescents aged 12–17 years were targeted from each village with a planned enrollment of 80. The intervention was held over a weekend, and youth traveled from their villages to quit tobacco use with other teens. The intervention comprised 8hr of group-based counseling. Talking circles, personal stories from elders, and recreational activities were included to enhance cultural acceptability and participation. Newsletters were mailed weekly for 5-weeks postprogram. Assessments were conducted at baseline, week 6 (end-of-treatment), and 6 months. Self-reported tobacco abstinence was confirmed with salivary cotinine. Results: Recruitment targets were met in the intervention (41 enrolled) but not in control villages (27 enrolled). All intervention participants attended the weekend program. Retention was high; 98% of intervention and 86% of control participants completed 6-month follow-up. The 7-day point-prevalence self-reported tobacco abstinence rates for intervention and control participants were 10% (4/41) and 0% (0/27) at both week 6 and 6 months (p = .15). Only 1 adolescent in the intervention condition was biochemically confirmed abstinent at week 6 and none at 6 months. Conclusion: The intensive individual-focused intervention used in this study was feasible but not effective for tobacco cessation among AN youth. Alternative approaches are warranted. PMID:24532352

  19. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    PubMed Central

    2011-01-01

    Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

  20. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse, quality of life and cost-effectiveness of the intervention. Data from a subsample of women in both groups will contribute to a nested qualitative study with repeat interviews during the year of follow-up. Discussion This study will contribute to the evidence base for management of the psychological needs of women experiencing DVA. The findings will have important implications for healthcare commissioners and providers, as well as third sector specialist DVA agencies providing services to this client group. Trial registration ISRCTN58561170 PMID:23866771

  1. Bright Start: Description and main outcomes from a group-randomized obesity prevention trial in American Indian children

    PubMed Central

    Story, Mary; Hannan, Peter J; Fulkerson, Jayne A.; Rock, Bonnie Holy; Smyth, Mary; Arcan, Chrisa; Himes, John H.

    2012-01-01

    The aim of the Bright Start study was to develop and test the effectiveness of a school environment intervention, supplemented with family involvement, to reduce excessive weight gain by increasing physical activity and healthy eating practices among kindergarten and first grade American Indian children. Bright Start was a group-randomized, school-based trial involving 454 children attending 14 schools on the Pine Ridge Reservation in South Dakota. Children were followed from the beginning of their kindergarten year through the end of first grade. Main outcome variables were mean BMI, mean percent body fat, and prevalence of overweight/obese children. The goals of the intervention were to: increase physical activity at school to at least 60 min/day; modify school meals and snacks; and involve families in making behavioral and environmental changes at home. At baseline, 32% of boys and 25% of girls were overweight/obese. While the intervention was not associated with statistically significant change in mean levels of BMI, BMI-Z, skinfolds or percentage body fat, the intervention was associated with a statistically significant net decrease of 10% in the prevalence of overweight. Intervention children experienced a 13.4% incidence of overweight, while the control children experienced a corresponding incidence of 24.8%; a difference of ?11.4% (p=0.033). The intervention significantly reduced parent reported mean child intakes of sugar-sweetened beverages, whole milk and chocolate milk. Changes in duration of school physical activity were not significant. Because obesity is the most daunting health challenge facing American Indian children today, more intervention research is needed to identify effective approaches. PMID:22513491

  2. TrialDB: A web-based Clinical Study Data Management System.

    PubMed

    Brandt, C A; Deshpande, A M; Lu, C; Ananth, G; Sun, K; Gadagkar, R; Morse, R; Rodriguez, C; Miller, P L; Nadkarni, P M

    2003-01-01

    Clinical Study Data Management Systems (CSDMSs) are a class of software that support centralized management of data generated during the conduct of clinical studies. Commercial CSDMSs include Oracle Clinical, ClinTrial and MetaTrial. Such systems, which are typically deployed at an institutional or organizational level, must accommodate diverse types of data from different clinical domains that is generated by different groups of clinical investigators. Large-scale CSDMSs typically employ a high-end database engine that is usually accessed over an intranet or the Internet using Web-based technologies. CSDMSs in institution-wide use for a variety of clinical domains are best served by entity-attribute-value (EAV) modeling for the clinical data: all the commercial CSDMSs that we are aware of use EAV design. However, de novo development of EAV databases for data management is a challenging task. A large body of generic metadata-driven code must be developed before a basic EAV application can be written. Clearly, the availability of pre-existing software with the requisite functionality would be very valuable. We will discuss the benefits of such software being in open-source form. PMID:14728299

  3. Pain Management in Cancer Patients Using a Mobile App: Study Design of a Randomized Controlled Trial

    PubMed Central

    Kamdar, Mihir; Flanagan, Clare; Searl, Meghan; Traeger, Lara; Kvedar, Joseph; Jethwani, Kamal

    2014-01-01

    Background Despite the availability of effective medications and clinical guidelines for pain management, pain control is suboptimal in a sizeable proportion of patients with cancer pain. The National Comprehensive Cancer Network guidelines recommend a comprehensive and multimodal approach for management of cancer pain. We developed a mobile phone application, ePAL, based on clinical guidelines to empower patients for cancer pain management by prompting regular pain assessments and coaching for self-management. Objective The objective of this study is to evaluate the effect of a multidimensional mobile phone-based pain management application, ePAL, on controlling cancer pain and improving quality of life in patients with cancer pain being treated at an academic palliative care clinic. Methods The study will be implemented as a 2-arm randomized controlled trial with 110 adult patients with CP who own a mobile phone over a follow-up period of two months. Participants will be randomized to either the intervention group receiving ePAL and usual care or to a control group receiving only usual care. The brief pain inventory will be used to assess our primary outcome which is pain intensity. We will also evaluate the effect of the intervention on secondary outcomes which include the effect of the intervention on hospital utilization for pain crisis, quality of life, adherence to analgesic medications, barriers to pain control, anxiety and patient engagement. Instruments that will be used in evaluating secondary outcomes include the Brief Pain Inventory, Morisky Medication Adherence Scale, Barriers Questionnaire-II, Functional Assessment of Cancer Therapy–General, Edmonton Symptom Assessment System, Generalized Anxiety Disorder 7-item scale, and the Functional Assessment of Chronic Illness Therapy-Fatigue. The intention-to-treat approach will be used to evaluate outcomes. Our primary outcome, pain intensity, measured longitudinally over eight weeks, will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations. Results The study is still in progress. We hope to have results by the end of 2015. Conclusions The multidimensional approach to pain management implemented on a mobile phone application could lead to significant improvements in patient outcomes. Trial Registration ClinicalTrials.gov NCT02069743; https://clinicaltrials.gov/ct2/show/NCT02069743 (Archived by WebCite at http://www.webcitation.org/6Qb65XGGA). PMID:25500281

  4. Social Studies Now!: Put Storybook Characters on Trial to Spark Students' Interest in the Justice System.

    ERIC Educational Resources Information Center

    Lindquist, Tarry

    1998-01-01

    This social studies activity helps primary students understand the trial process by putting literary characters on trial (e.g., Goldilocks for breaking and entering or Cruella DeVille for stealing dalmatians). Alternatively, students can try real-life problems such as bullying on the playground. Through role playing, students learn how the justice…

  5. Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials

    PubMed Central

    Stein, Donald G.

    2015-01-01

    Abstract Background: Despite positive preclinical studies and two positive Phase II clinical trials, two large Phase III clinical trials of progesterone treatment of acute traumatic brain injury (TBI) recently ended with negative results, so a 100% failure rate continues to plague the field of TBI trials. Methods: This paper reviews and analyses the trial structures and outcomes and discusses the implications of these failures for future drug and clinical trial development. Persistently negative trial outcomes have led to disinvestment in new drug research by companies and policy-makers and disappointment for patients and their families, failures which represent a major public health concern. The problem is not limited to TBI. Failure rates are high for trials in stroke, sepsis, cardiology, cancer and orthopaedics, among others. Results: This paper discusses some of the reasons why the Phase III trials have failed. These reasons may include faulty extrapolation from pre-clinical data in designing clinical trials and the use of subjective outcome measures that accurately reflect neither the nature of the deficits nor long-term quantitative recovery. Conclusions: Better definitions of injury and healing and better outcome measures are essential to change the embrace of failure that has dominated the field for over 30 years. This review offers suggestions to improve the situation. PMID:26274493

  6. Results of an intervention study to improve communication about randomised clinical trials of cancer therapy. | accrualnet.cancer.gov

    Cancer.gov

    The authors conducted an intervention study to improve communication during consultation about randomized trials. Questionnaires were used to collect information about patients’ information needs and their attitudes toward clinical trials. The Preferences for Information Questionnaire was helpful to doctors in understanding their patients’ interest in receiving specific details about clinical trials. The Patient Attitudes to Trials Questionnaire accurately predicted which patients would consent to enroll in the trials they were offered.

  7. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website ‘Living well with asthma’ which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. Methods/Design The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Discussion Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of efficacy to inform the design of a future full-scale randomized controlled trial of the ‘Living well with asthma’ website. Trial registration This trial is registered with Current Controlled Trials ISRCTN78556552 on 18/06/13. PMID:24884722

  8. 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 Central

    2014-01-01

    Background 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. Methods/design 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. Discussion The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse, and bring about improvements across a range of physical health outcomes. Trial registration Current Controlled Trials ISRCTN74390532, 26.03.2013. PMID:24886116

  9. Time from Prior Chemotherapy Enhances Prognostic Risk Grouping in the Second-line Setting of Advanced Urothelial Carcinoma: A Retrospective Analysis of Pooled, Prospective Phase 2 Trials

    PubMed Central

    Sonpavde, Guru; Pond, Gregory R.; Fougeray, Ronan; Choueiri, Toni K.; Qu, Angela Q.; Vaughn, David J.; Niegisch, Guenter; Albers, Peter; James, Nicholas D.; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S.; Galsky, Matthew D.; Petrylak, Daniel P.; Vaishampayan, Ulka N.; Khan, Awais; Vogelzang, Nicholas J.; Beer, Tomasz M.; Stadler, Walter M.; O’Donnell, Peter H.; Sternberg, Cora N.; Rosenberg, Jonathan E.; Bellmunt, Joaquim

    2014-01-01

    Background Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM). Objectives The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Design, setting, and participants: Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n = 570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n = 352). Outcome measurements and statistical analysis Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. Results and limitations ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic = 0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable. Conclusions Shorter TFPC enhances prognostic classification independent of ECOG-PS>0, Hb<10 g/ dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. PMID:23206856

  10. Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial

    PubMed Central

    2013-01-01

    Background Perineal trauma during childbirth affects millions of women worldwide every year. The aim of the Perineal Assessment and Repair Longitudinal Study (PEARLS) was to improve maternal clinical outcomes following childbirth through an enhanced cascaded multiprofessional training program to support implementation of evidence-based perineal management. Methods This was a pragmatic matched-pair cluster randomized controlled trial (RCT) that enrolled women (n = 3681) sustaining a second-degree perineal tear in one of 22 UK maternity units (clusters), organized in 11 matched pairs. Units in each matched pair were randomized to receive the training intervention either early (group A) or late (group B). Outcomes within each cluster were assessed prior to any training intervention (phase 1), and then after the training intervention was given to group A (phase 2) and group B (phase 3). Focusing on phase 2, the primary outcome was the percentage of women who had pain on sitting or walking at 10 to 12 days post-natal. Secondary outcomes included use of pain relief at 10 to 12 days post-natal, need for suture removal, uptake and duration of exclusive breastfeeding, and perineal wound infection. Practice-based measures included implementation of evidence into practice to promote effective clinical management of perineal trauma. Cluster-level paired t-tests were used to compare groups A and B. Results There was no significant difference between the clusters in phase 2 of the study in the average percentage of women reporting perineal pain on sitting and walking at 10 to 12 days (mean difference 0.7%; 95% CI ?10.1% to 11.4%; P = 0.89). The intervention significantly improved overall use of evidence-based practice in the clinical management of perineal trauma. Following the training intervention, group A clusters had a significant reduction in mean percentages of women reporting perineal wound infections and of women needing sutures removed. Conclusion PEARLS is the first RCT to assess the effects of a ‘training package on implementation of evidence-based perineal trauma management. The intervention did not significantly improve the primary outcome but did significantly improve evidence-based practice and some of the relevant secondary clinical outcomes for women. Trial registrations ISRCTN28960026 NIHR UKCRN portfolio no: 4785. PMID:24059602

  11. Reporting practices of pharmacodynamic studies involving invasive research procedures in cancer trials

    PubMed Central

    Freeman, G A; Kimmelman, J; Dancey, J; Monzon, J G

    2013-01-01

    Background: Tumour biopsy for pharmacodynamic (PD) study is increasingly common in early-phase cancer trials. As they are non-diagnostic, the ethical justification for such procedures rests on their knowledge value. On the premise that knowledge value is related to reporting practices and outcome diversity, we assessed in a sample of recent invasive PD studies within cancer trials. Methods: We assessed reporting practices and outcomes for PD studies in a convenience sample of cancer trials published from 2000 to 2010 that employed invasive, non-diagnostic tissue procurement. Extracted data were used to measure outcome reporting in individual trials. Using a reporting scale we developed for exploratory purposes, we tested whether reporting varied with study characteristics, such as funding source or drug novelty. Results: Reporting varied widely within and across studies. Some practices were sporadically reported, including results of all planned tests (78% trials reporting), use of blinded histopathological assessment (43% trials reporting), biopsy dimensions (38% trials reporting), and description of patient flow through PD analysis (62%). Pharmacodynamic analysis as a primary end point and mandatory biopsy had statistically significant positive relationships with overall quality of reporting. A preponderance of positive results (61% of the studies described positive PD results) suggests possible publication bias. Conclusion: Our results highlight the need for PD-reporting guidelines, and suggest several avenues for improving the risk/benefit for studies involving invasive, non-diagnostic tissue procurement. PMID:23887602

  12. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study.

    PubMed

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L; Siersma, Volkert

    2008-11-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed by the patient at 0, 1, 3, 6, 9 and 12 months and knee score and knee function assessed by an orthopaedic surgeon at 0, 6 and 12 months. Within the first month, three patients dropped out. The remaining 21/19 patients in the intervention/control groups generally improved, but there was no statistically significant difference between the groups. The improvement was shown in the patients' self-assessment scores that decreased from randomisation until 1 year later (intervention/control group, medians): pain -1.92/-2.18 (P = 0.95, F test, general linear mixed model); stiffness -0.93/-0.43 (P = 0.11); function -7.23/-3.36 (P = 0.63). The surgeon's scores also generally improved, i.e. increased: knee score +16.4/+8.2 (P = 0.65); knee function +10.5/+5.8 (P = 0.79). In the protocol-based subgroup analysis, the 15 intervention patients of the 32 patients who had a positive response to the initial conventional acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial including only patients who respond positively to initial conventional acupuncture. PMID:18500437

  13. Case management for frequent users of the emergency department: study protocol of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background We devised a randomised controlled trial to evaluate the effectiveness and efficiency of an intervention based on case management care for frequent emergency department users. The aim of the intervention is to reduce such patients’ emergency department use, to improve their quality of life, and to reduce costs consequent on frequent use. The intervention consists of a combination of comprehensive case management care and standard emergency care. It uses a clinical case management model that is patient-identified, patient-directed, and developed to provide high intensity services. It provides a continuum of hospital- and community-based patient services, which include clinical assessment, outreach referral, and coordination and communication with other service providers. Methods/Design We aim to recruit, during the first year of the study, 250 patients who visit the emergency department of the University Hospital of Lausanne, Switzerland. Eligible patients will have visited the emergency department 5 or more times during the previous 12 months. Randomisation of the participants to the intervention or control groups will be computer generated and concealed. The statistician and each patient will be blinded to the patient’s allocation. Participants in the intervention group (N?=?125), additionally to standard emergency care, will receive case management from a team, 1 (ambulatory care) to 3 (hospitalization) times during their stay and after 1, 3, and 5 months, at their residence, in the hospital or in the ambulatory care setting. In between the consultations provided, the patients will have the opportunity to contact, at any moment, the case management team. Participants in the control group (N?=?125) will receive standard emergency care only. Data will be collected at baseline and 2, 5.5, 9, and 12 months later, including: number of emergency department visits, quality of life (EuroQOL and WHOQOL), health services use, and relevant costs. Data on feelings of discrimination and patient’s satisfaction will also be collected at the baseline and 12 months later. Discussion Our study will help to clarify knowledge gaps regarding the positive outcomes (emergency department visits, quality of life, efficiency, and cost-utility) of an intervention based on case management care. Trial registration ClinicalTrials.gov Identifier: NCT01934322. PMID:24938769

  14. A matter of life and death? The Heart Protection Study and protection of clinical trial participants. | accrualnet.cancer.gov

    Cancer.gov

    The study discusses whether and how interim data and analyses should be made available to physician-investigators, the trial participants, and the public. The issues are related to optimizing the protection of study subjects in clinical trials.

  15. Incomplete Reconstitution of T Cell Subsets on Combination Antiretroviral Therapy in the AIDS Clinical Trials Group Protocol 384

    PubMed Central

    Robbins, Gregory K.; Spritzler, John G.; Chan, Ellen S.; Asmuth, David M.; Gandhi, Rajesh T.; Rodriguez, Benigno A.; Skowron, Gail; Skolnik, Paul R.; Shafer, Robert W.; Pollard, Richard B.

    2009-01-01

    Background Initiation of combination antiretroviral therapy (ART) results in higher total CD4 cell counts, a surrogate for immune reconstitution. Whether the baseline CD4 cell count affects reconstitution of immune cell subsets has not been well characterized. Methods Using data from 978 patients (621 with comprehensive immunological assessments) from the AIDS [Acquired Immunodeficiency Syndrome] Clinical Trials Group protocol 384, a randomized trial of initial ART, we compared reconstitution of CD4+, CD4+ naive and memory, CD4+ activation, CD8+, CD8+ activation, B, and natural killer cells among patients in different baseline CD4+ strata. Reference ranges for T cell populations in control patients negative for human immunodeficiency virus (HIV) infection were calculated using data from AIDS Clinical Trials Group protocol A5113. Results Patients in the lower baseline CD4+ strata did not achieve total CD4+ cell counts similar to those of patients in the higher strata during 144 weeks of ART, although CD4+ cell count increases were similar. Ratios of CD4+ naive-memory cell counts and CD4+:CD8+ cell counts remained significantly reduced in patients with lower baseline CD4+ cell counts (?350 cells/mm3). These immune imbalances were most notable for those initiating ART with a baseline CD4+ cell count ?200 cells/mm3, even after adjustment for baseline plasma HIV RNA levels. Conclusions After nearly 3 years of ART, T cell subsets in patients with baseline CD4+ cell counts >350 cells/mm3 achieved or approached the reference range those of control individuals without HIV infection. In contrast, patients who began ART with ?350 CD4+ cells/mm3 generally did not regain normal CD4+ naive-memory cell ratios. These results support current guidelines to start ART at a threshold of 350 cells/mm3 and suggest that there may be immunological benefits associated with initiating therapy at even higher CD4+ cell counts. PMID:19123865

  16. WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial

    PubMed Central

    2014-01-01

    Background The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. Methods/Design This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18–65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. Discussion This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes and inform the evaluation strategy, including sample size calculation, for a future definitive RCT. Trial registration Current Controlled Trials ISRCTN04199273 – WELLFOCUS study: an intervention to improve well-being in people with psychosis, Date registered: 27 March 2013, first participant randomised on 26 April 2013. PMID:24888479

  17. RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial

    PubMed Central

    Jopson, Laura; Newton, Julia L; Palmer, Jeremy; Floudas, Achilleas; Isaacs, John; Qian, Jessica; Wilkinson, Jennifer; Trenell, Mike; Blamire, Andrew; Howel, Denise; Jones, David E

    2015-01-01

    Introduction Primary biliary cirrhosis (PBC) is an autoimmune liver disease with approximately 50% of patients experiencing fatigue. This can be a particularly debilitating symptom, affecting quality of life and resulting in social isolation. Fatigue is highlighted by patients as a priority for research and patient support groups were involved in designing this trial. This is the first randomised controlled trial to investigate a treatment for fatigue in PBC. The trial protocol is innovative as it utilises novel magnetic resonance spectroscopy (MRS) techniques as an outcome measure. The protocol will be valuable to research groups planning clinical trials targeting fatigue in PBC and also transferrable to other conditions associated with fatigue. Methods and analysis RITPBC is a Medical Research Council (MRC) and National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Programme (EME)-funded project. It is a phase II, single-centre, randomised controlled, double-blinded trial comparing rituximab with placebo in fatigued PBC patients. 78 patients with PBC and moderate to severe fatigue will be randomised to receive two infusions of rituximab or placebo. The study aims to assess whether rituximab improves fatigue in patients with PBC, the safety, and tolerability of rituximab in PBC and the sustainability of any beneficial actions. The primary outcome will be an improvement in fatigue domain score of the PBC-40, a disease-specific quality of life measure, evaluated at 12-week assessment. Secondary outcome measures include novel MRS techniques assessing muscle bioenergetic function, physical activity, anaerobic threshold and symptom, and quality of life measures. The trial started recruiting in October 2012 and recruitment is ongoing. Ethics and dissemination The trial has ethical approval from the NRES Committee North East, has Clinical Trial Authorisation from MHRA and local R&D approval. Trial results will be communicated to participants, presented at national and international meetings and published in peer-reviewed journals. Trial registration number ISRCTN03978701. PMID:26297361

  18. Group hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol

    PubMed Central

    2012-01-01

    Background A significant number of smokers would like to stop smoking. Despite the demonstrated efficacy of pharmacological smoking cessation treatments, many smokers are unwilling to use them; however, they are inclined to try alternative methods. Hypnosis has a long-standing reputation in smoking cessation therapy, but its efficacy has not been scientifically proven. We designed this randomised controlled trial to evaluate the effects of group hypnosis as a method for smoking cessation, and we will compare the results of group hypnosis with group relaxation. Methods/Design This is a randomised controlled trial (RCT) to compare the efficacy of a single session of hypnosis with that of relaxation performed in groups of 8-15 smokers. We intend to include at least 220 participants in our trial. The inclusion criteria include smoking at least 5 cigarettes per day, not using other cessation methods and being willing to quit smoking. The intervention is performed by a trained hypnotist/relaxation therapist. Both groups first receive 40 min of mental preparation that is based on motivational interviewing. Then, a state of deep relaxation is induced in the hypnosis condition, and superficial relaxation is induced in the control condition. Suggestions are made in the hypnosis condition that aim to switch the mental self-image of the participants from that of smokers to that of non-smokers. Each intervention lasts for 40 min. The participants also complete questionnaires that assess their smoking status and symptoms of depression and anxiety at baseline, 2 weeks and 6 months post-intervention. In addition, saliva samples are collected to assess cotinine levels at baseline and at 6 months post-intervention. We also assess nicotine withdrawal symptoms at 2 weeks post-intervention. Discussion To the best of our knowledge, this RCT is the first to test the efficacy of group hypnosis versus group relaxation. Issues requiring discussion in the outcome paper include the lack of standardisation of hypnotic interventions in smoking cessation, the debriefing of the participants, the effects of group dynamics and the reasons for dropouts. Trial registration Current Controlled Trials, ISRCTN72839675. PMID:22475087

  19. 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

  20. Do standards for the design and reporting of nonpharmacological trials facilitate hypnotherapy studies?

    PubMed

    Marc, Isabelle; Pelland-Marcotte, Marie-Claude; Ernst, Edzard

    2011-01-01

    The design and quality of 30 recent hypnotherapy trials (years 2000-2008) were assessed using the checklist for evaluating a report of nonpharmacological treatment (CLEAR NPT). Randomization was adequately reported in 53% of studies. The masking of participants and care providers is not feasible in hypnotherapy studies. Assessor masking is rarely introduced in randomized, controlled trials (27%). Reporting and quality of published hypnotherapy trials need to be improved. Investigators may consider using CLEAR NPT to evaluate study quality but attention should be paid to document intervention adherence, standardization of cointerventions, participant and care-provider expectations and beliefs, and, finally, hypnotizability. PMID:21104485

  1. Hygienic-dietary recommendations for major depression treatment: Study protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice. Methods Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up. Discussion We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs. Trial registration ISRCTN73931675 PMID:23158080

  2. Toxicological Studies of 212Pb Intravenously or Intraperitoneally Injected into Mice for a Phase 1 Trial

    PubMed Central

    Milenic, Diane E.; Molinolo, Alfredo A.; Solivella, María S.; Banaga, Eileen; Torgue, Julien; Besnainou, Sarah; Brechbiel, Martin W.; Baidoo, Kwamena E.

    2015-01-01

    Faced with the novelty of a 212Pb-labeled monoclonal antibody (mAb) for clinical translation, concerns were expressed by the Food and Drug Administration (FDA) regarding 212Pb prematurely released from the mAb-chelate conjugate. The objective of this study was to simulate the worst case scenario of such a failure. Groups of Balb/c mice (n = 9–20) were administered 212Pb by intraperitoneal (0.0925–1.85 MBq) or intravenous (0.0925–1.11 MBq) injection and then euthanized at 7 or 90 days to assess acute or chronic effects. Weights were recorded prior to injection of the 212Pb and at the end of the observation periods. Blood samples were collected for clinical chemistry and blood cell analysis. Thirty tissues were harvested and formalin fixed for histopathological examination. Treatment related effects of the 212Pb were observed in the bone marrow, spleen, kidneys and the liver. Histological alterations in these organs were considered mild to moderate, indicating low grade toxicity, and not considered severe enough to affect function. This data was presented to the FDA and determined to be acceptable. The clinical trial with 212Pb-TCMC-trastuzumab was approved in January 2011 and the trial opened at the University of Alabama at Birmingham (UAB) in July. PMID:26213947

  3. 'Rumours' and clinical trials: a retrospective examination of a paediatric malnutrition study in Zambia, southern Africa

    PubMed Central

    2010-01-01

    Background Many public health researchers conducting studies in resource-constrained settings have experienced negative 'rumours' about their work; in some cases they have been reported to create serious challenges and derail studies. However, what may appear superficially as 'gossip' or 'rumours' can also be regarded and understood as metaphors which represent local concerns. For researchers unaccustomed to having concerns expressed from participants in this manner, possible reactions can be to be unduly perturbed or conversely dismissive. This paper represents a retrospective examination of a malnutrition study conducted by an international team of researchers in Zambia, Southern Africa. The fears of mothers whose children were involved in the study and some of the concerns which were expressed as rumours are also presented. This paper argues that there is an underlying logic to these anxieties and to dismiss them simply as 'rumours' or 'gossip' would be to overlook the historic and socio-economic factors which have contributed to their production. Methods Qualitative interviews were conducted with the mothers whose children were involved in the study and with the research nurses. Twenty five face-to-face interviews and 2 focus group discussions (FGDs) were conducted with mothers. In addition, face-to-face interviews were conducted with research nurses participating in the trial. Results A prominent anxiety expressed as rumours by the mothers whose children were involved in the study was that recruitment into the trial was an indicator that the child was HIV-infected. Other anxieties included that the trial was a disguise for witchcraft or Satanism and that the children's body parts would be removed and sold. In addition, the liquid, milk-based food given to the children to improve their nutrition was suspected of being insufficiently nutritious, thus worsening their condition. The form which these anxieties took, such as rumours related to the stealing of body parts and other anxieties about a stigmatised condition, provide an insight into the historical, socio-economic and cultural influences in such settings. Conclusions Employing strategies to understand local concerns should accompany research aims to achieve optimal success. The concerns raised by the participants we interviewed are not unique to this study. They are produced in countries where the historic, socio-economic and cultural settings communicate anxieties in this format. By examining this study we have shown that by contextualizing these 'rumours', the concerns they express can be constructively addressed and in turn result in the successful conduct of research aims. PMID:20849580

  4. Water cycle study group town hall meeting

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    The development of a global water cycle initiative for fiscal year 2000 and beyond is the topic of a “town hall” meeting to be held during the AGU Fall Meeting in San Francisco on Monday December 13, from 5:30 p.m.-7:00 p.m.The meeting will be conducted by a water cycle study group appointed by the U.S. Global Change Research Program (USGCRP).The group's charge is to “formulate a research strategy and scientific plan for investigating the global water cycle, its role in climate, and the fundamental processes that govern the availability and the biogeochemistry of water resources, [and to] develop the strategy and science plan for a national program.”

  5. Format and readability of an enhanced invitation letter did not affect participation rates in a cancer registry-based study: a randomized controlled trial. | accrualnet.cancer.gov

    Cancer.gov

    A standard invitation letter was compared with an enhanced letter to investigate the effect of improved communication efforts on clinical trial enrollment of hematological cancer survivors. The enhanced letter incorporated content and design characteristics suggested by the literature to improve readability and comprehension. Half of a sample of 800 patients received each letter, forming experimental and control groups. Of the eligible survivors, 268 completed the study questionnaire (131 in the experimental group and 137 in the control group).

  6. Bortezomib in late antibody-mediated kidney transplant rejection (BORTEJECT Study): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Despite major advances in transplant medicine, improvements in long-term kidney allograft survival have not been commensurate with those observed shortly after transplantation. The formation of donor-specific antibodies (DSA) and ongoing antibody-mediated rejection (AMR) processes may critically contribute to late graft loss. However, appropriate treatment for late AMR has not yet been defined. There is accumulating evidence that the proteasome inhibitor bortezomib may substantially affect the function and integrity of alloantibody-secreting plasma cells. The impact of this agent on the course of late AMR has not so far been systematically investigated. Methods/design The BORTEJECT Study is a randomized controlled trial designed to clarify the impact of intravenous bortezomib on the course of late AMR. In this single-center study (nephrological outpatient service, Medical University Vienna) we plan an initial cross-sectional DSA screening of 1,000 kidney transplant recipients (functioning graft at ?180 days; estimated glomerular filtration rate (eGFR) >20 ml/minute/1.73 m2). DSA-positive recipients will be subjected to kidney allograft biopsy to detect morphological features consistent with AMR. Forty-four patients with biopsy-proven AMR will then be included in a double-blind placebo-controlled intervention trial (1:1 randomization stratified for eGFR and the presence of T-cell-mediated rejection). Patients in the active group will receive two cycles of bortezomib (4?×?1.3 mg/m2 over 2 weeks; 3-month interval between cycles). The primary end point will be the course of eGFR over 24 months (intention-to-treat analysis). The sample size was calculated according to the assumption of a 5 ml/minute/1.73 m2 difference in eGFR slope (per year) between the two groups (alpha: 0.05; power: 0.8). Secondary endpoints will be DSA levels, protein excretion, measured glomerular filtration rate, transplant and patient survival, and the development of acute and chronic morphological lesions in 24-month protocol biopsies. Discussion The impact of anti-humoral treatment on the course of late AMR has not yet been systematically investigated. Based on the hypothesis that proteasome inhibition improves the outcome of DSA-positive late AMR, we suggest that our trial has the potential to provide solid evidence towards the treatment of this type of rejection. Trial registration Clinicaltrials.gov: NCT01873157. PMID:24708575

  7. PEDro or Cochrane to Assess the Quality of Clinical Trials? A Meta-Epidemiological Study

    PubMed Central

    Armijo-Olivo, Susan; da Costa, Bruno R.; Cummings, Greta G.; Ha, Christine; Fuentes, Jorge; Saltaji, Humam; Egger, Matthias

    2015-01-01

    Objective There is debate on how the methodological quality of clinical trials should be assessed. We compared trials of physical therapy (PT) judged to be of adequate quality based on summary scores from the Physiotherapy Evidence Database (PEDro) scale with trials judged to be of adequate quality by Cochrane Risk of Bias criteria. Design Meta-epidemiological study within Cochrane Database of Systematic Reviews. Methods Meta-analyses of PT trials were identified in the Cochrane Database of Systematic Reviews. For each trial PeDro and Cochrane assessments were extracted from the PeDro and Cochrane databases. Adequate quality was defined as adequate generation of random sequence, concealment of allocation, and blinding of outcome assessors (Cochrane criteria) or as trials with a PEDro summary score ?5 or ?6 points. We combined trials of adequate quality using random-effects meta-analysis. Results Forty-one Cochrane reviews and 353 PT trials were included. All meta-analyses included trials with PEDro scores ?5, 37 (90.2%) included trials with PEDro scores ?6 and only 22 (53.7%) meta-analyses included trials of adequate quality according to the Cochrane criteria. Agreement between PeDro and Cochrane was poor for PeDro scores of ?5 points (kappa = 0.12; 95% CI 0.07 to 0.16) and slight for ?6 points (kappa 0.24; 95% CI 0.16-0.32). When combining effect sizes of trials deemed to be of adequate quality according to PEDro or Cochrane criteria, we found that a substantial difference in the combined effect size (?0.15) was evident in 9 (22%) out of the 41 meta-analyses for PEDro cutoff ?5 and 10 (24%) for cutoff ?6. Conclusions The PeDro and Cochrane approaches lead to different sets of trials of adequate quality, and different combined treatment estimates from meta-analyses of these trials. A consistent approach to assessing RoB in trials of physical therapy should be adopted. PMID:26161653

  8. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    PubMed Central

    2011-01-01

    Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs) are supported in convening monthly women's groups. Nine groups per cluster (270 in total) work through two action research cycles in which they (i) identify local issues around maternity, newborn health and nutrition, (ii) prioritise key problems, (iii) develop strategies to address them, (iv) implement the strategies, and (v) evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i) identify local births, (ii) identify low birth weight infants, (iii) identify possible newborn infection, (iv) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v) follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal diet, breastfeeding and complementary feeding practices, maternal and under-2 anthropometric status. MIRA Dhanusha sepsis management: identification and treatment of neonatal sepsis by community health volunteers, infection-specific neonatal mortality. Trial Registration no ISRCTN: ISRCTN87820538 PMID:21635791

  9. Predictors of Study Completion and Withdrawal in a Randomized Clinical Trial of a Pediatric Diabetes Adherence Intervention

    PubMed Central

    Driscoll, Kimberly A.; Killian, Michael; Johnson, Suzanne Bennett; Silverstein, Janet H.; Deeb, Larry C.

    2010-01-01

    Purpose Loss of participants in randomized clinical trials threatens the validity of study findings. The purpose of this study was to determine pre-randomization predictors of study withdrawal throughout the course of a randomized clinical trial involving young children with type 1 diabetes and their primary caregivers. Methods An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child’s regular 3-month diabetes clinic visit. The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group. Among those who completed the study and regardless of treatment group, participants were categorized into two groups: On-Time Completers (n = 41) and Late Completers (n = 39). Demographic, disease, and psychosocial characteristics of children and their primary caregivers measured prior to study randomization were tested for their association with the participants’ completion status (i.e., On-Time Completers, Late Completers, or Withdrawals). Results Of the 108 participants, 28 (25.9%) withdrew and 80 (74.1%) completed the study. On-Time Completers (i.e., study completed within 4 months of expected date) were more likely to have private insurance and primary caregivers with some college education. Late Completers (i.e., study completion took longer than 4 months) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression. Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home. Conclusions Pre-randomization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence, permitting the investigators to develop retention strategies aimed at this high-risk group. PMID:19470311

  10. Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol

    PubMed Central

    2014-01-01

    Background New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration Clinical Trials.gov Identifier: NCT02016014 PMID:24628961

  11. Trial Prospector: Matching Patients with Cancer Research Studies Using an Automated and Scalable Approach

    PubMed Central

    Sahoo, Satya S; Tao, Shiqiang; Parchman, Andrew; Luo, Zhihui; Cui, Licong; Mergler, Patrick; Lanese, Robert; Barnholtz-Sloan, Jill S; Meropol, Neal J; Zhang, Guo-Qiang

    2014-01-01

    Cancer is responsible for approximately 7.6 million deaths per year worldwide. A 2012 survey in the United Kingdom found dramatic improvement in survival rates for childhood cancer because of increased participation in clinical trials. Unfortunately, overall patient participation in cancer clinical studies is low. A key logistical barrier to patient and physician participation is the time required for identification of appropriate clinical trials for individual patients. We introduce the Trial Prospector tool that supports end-to-end management of cancer clinical trial recruitment workflow with (a) structured entry of trial eligibility criteria, (b) automated extraction of patient data from multiple sources, (c) a scalable matching algorithm, and (d) interactive user interface (UI) for physicians with both matching results and a detailed explanation of causes for ineligibility of available trials. We report the results from deployment of Trial Prospector at the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center (Case CCC) with 1,367 clinical trial eligibility evaluations performed with 100% accuracy. PMID:25506198

  12. Challenges with participant reimbursement: experiences from a post-trial access study.

    PubMed

    Mngadi, Kathryn Therese; Frohlich, Janet; Montague, Carl; Singh, Jerome; Nkomonde, Nelisiwe; Mvandaba, Nomzamo; Ntombeka, Fanelesibonge; Luthuli, Londiwe; Abdool Karim, Quarraisha; Mansoor, Leila

    2015-11-01

    Reimbursement of trial participants remains a frequently debated issue, with specific guidance lacking. Trials combining post-trial access and implementation science may necessitate new strategies and models. CAPRISA 008, a post-trial access study testing the feasibility of using family planning services to rollout a prelicensure HIV prevention intervention, tried to balance the real-life scenario of no reimbursement for attendance at public sector clinics with that of a trial including some visits that focused on research procedures and others that focused on standard of care procedures. A reduced reimbursement was offered for 'standard of care' visits, meant primarily to cover transport costs to and from the clinic only. This impacted negatively on accrual, retention and participant morale, primarily due to the protracted delay in regulatory approval, during which time, the costs of living, including travel costs had increased. Relevant guidelines were reviewed and institutional policy was updated to incorporate the South African National Health Research Ethics Committee guidelines on reimbursement (taking into account participant time, travel and inconvenience). The reimbursement amount for 'standard of care' visits was increased accordingly. The question remains whether a trial that combines post-trial access with implementation science, with clear benefits for the participants and the provision of above standard medical care, should have reimbursement rates that approach those of a proof-of-concept trial, for 'standard of care' visits. PMID:26392172

  13. Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. Methods/Design Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the medical outcomes study (MOS) item short form health survey (SF-36). Analysis will be on intention-to-treat and per-protocol subject analysis principles. Discussion To address the effectual remission of the YXBCM01 granule for PV, this trial may provide a novel regimen for PV patients if the granule can decrease relapse rate without more adverse effects. Trial registration Chinese Clinical Trial Registry (http://cwww.chictr.org): ChiCTR-TRC-13003233, registered 26 May 2013. PMID:25052161

  14. Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients’ mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. Methods/design The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. Discussion The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD. This novel treatment format, if shown effective, could represent a cost-effective option and could further be modified to treat other conditions, as well. Trial registration ISRCTN75894275 PMID:24735420

  15. Ozurdex® (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Proliferative vitreoretinopathy (PVR) is the commonest cause of late anatomical failure in rhegmatogenous retinal detachment. Visual and anatomical outcomes remain poor despite advances in vitreoretinal surgical techniques with reported primary failure rates of up to nearly 50%. Numerous adjunctive medications have been evaluated in clinical trials with no agent gaining widespread acceptance and use. This study was designed to investigate the benefits of using a slow-release dexamethasone implant delivered intra-operatively in patients undergoing vitrectomy surgery for retinal detachment with established PVR. Methods/design For the study, 140 patients requiring vitrectomy surgery with silicone oil for retinal detachment with established PVR will be randomised to receive either standard treatment or study treatment in a 1:1 treatment allocation ratio. Both groups will receive the standard surgical treatment appropriate for their eye condition and routine peri-operative treatment and care, differing only in the addition of the supplementary adjunctive agent in the treatment group. The investigated primary outcome measure is stable retinal reattachment with removal of silicone oil without additional vitreoretinal surgical intervention at 6 months. Discussion This is the first randomised controlled clinical trial to investigate the use of an adjunctive slow-release dexamethasone implant in patients undergoing vitrectomy surgery for retinal detachments with proliferative vitreoretinopathy. Trial registration EudraCT No: 2011-004498-96. PMID:24165545

  16. PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial

    PubMed Central

    Cooke, Marie; Rickard, Claire; Rapchuk, Ivan; Shekar, Kiran; Marshall, Andrea P; Comans, Tracy; Doi, Suhail; McDonald, John; Spooner, Amy

    2014-01-01

    Introduction Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach. Methods and analysis 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36?h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV. Ethics and dissemination Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results. Trial registration number Australian New Zealand Clinical Trials Registry—ACTRN12614000589684. PMID:25394818

  17. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group.

    PubMed

    Hewitt, R G; Yiannoutsos, C T; Higgs, E S; Carey, J T; Geiseler, P J; Soave, R; Rosenberg, R; Vazquez, G J; Wheat, L J; Fass, R J; Antoninievic, Z; Walawander, A L; Flanigan, T P; Bender, J F

    2000-10-01

    To evaluate the efficacy of paromomycin for the treatment of symptomatic cryptosporidial enteritis in human immunodeficiency virus-infected adults, we conducted a prospective, randomized, double-blind, placebo-controlled trial before the widespread introduction of highly active antiretroviral therapy (HAART). Seven units under the auspices of the AIDS Clinical Trials Group enrolled 35 adults with CD4 cell counts of < or = 150/mm(3). Initially, 17 patients received paromomycin (500 mg 4 times daily) and 18 received matching placebo for 21 days. Then all patients received paromomycin (500 mg q.i.d.) for an additional 21 days. Clinical definitions of response were measured by an average number of bowel movements per day in association with concurrent need for antidiarrheal agents that was lower than that before study entry. There was no treatment response during the placebo-controlled phase of the study according to protocol-defined criteria (P=.88). Three paromomycin recipients (17.6%) versus 2 placebo recipients (14.3%) responded completely. Rates of combined partial and complete responses in the paromomycin arm (8 out of 17, 47.1%) and the placebo arm (5 out of 14, 35.7%) of the study were also similar (P=.72). The clinical course of cryptosporidiosis was quite variable. Paromomycin was not shown to be more effective than placebo for the treatment of symptomatic cryptosporidial enteritis. However, inadequate statistical power prevents definitive rejection of the usefulness of paromomycin as therapy for this infection. PMID:11049793

  18. An analysis of two island groups as potential sites for trials of transgenic mosquitoes for malaria control

    PubMed Central

    Marsden, Clare D; Cornel, Anthony; Lee, Yoosook; Sanford, Michelle R; Norris, Laura C; Goodell, Parker B; Nieman, Catelyn C; Han, Sarah; Rodrigues, Amabelia; Denis, Joao; Ouledi, Ahmed; Lanzaro, Gregory C

    2013-01-01

    Considerable technological advances have been made towards the generation of genetically modified mosquitoes for vector control. In contrast, less progress has been made towards field evaluations of transformed mosquitoes which are critical for evaluating the success of, and hazards associated with, genetic modification. Oceanic islands have been highlighted as potentially the best locations for such trials. However, population genetic studies are necessary to verify isolation. Here, we used a panel of genetic markers to assess for evidence of genetic isolation of two oceanic island populations of the African malaria vector, Anopheles gambiae s.s. We found no evidence of isolation between the Bijagós archipelago and mainland Guinea-Bissau, despite separation by distances beyond the known dispersal capabilities of this taxon. Conversely, the Comoros Islands appear to be genetically isolated from the East African mainland, and thus represent a location worthy of further investigation for field trials. Based on assessments of gene flow within and between the Comoros islands, the island of Grande Comore was found to be genetically isolated from adjacent islands and also exhibited local population structure, indicating that it may be the most suitable site for trials with existing genetic modification technologies. PMID:23789035

  19. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    SciTech Connect

    Cui Yunfeng; Galvin, James M.; Radiation Therapy Oncology Group, American College of Radiology, Philadelphia, Pennsylvania ; Parker, William; Breen, Stephen; Yin Fangfang; Cai Jing; Papiez, Lech S.; Li, X. Allen; Bednarz, Greg; Chen Wenzhou; Xiao Ying

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA for RTOG clinical trials is feasible and effective. The magnitude of registration discrepancy between institution and reviewer was presented, and the major issues were investigated to further improve this remote evaluation process.

  20. A cluster randomised controlled trial of a comprehensive accreditation intervention to reduce alcohol consumption at community sports clubs: study protocol

    PubMed Central

    Wolfenden, Luke; Rowland, Bosco C; Tindall, Jennifer; Gillham, Karen E; McElduff, Patrick; Rogerson, John C; Wiggers, John H

    2011-01-01

    Introduction Excessive alcohol consumption is responsible for considerable harm from chronic disease and injury. Within most developed countries, members of sporting clubs consume alcohol at levels above that of communities generally. Despite the potential benefits of interventions to address alcohol consumption in sporting clubs, there have been no randomised controlled trials to test the effectiveness of these interventions. The aim of this study is to examine the effectiveness of a comprehensive accreditation intervention with community football clubs (Rugby League, Rugby Union, soccer/association football and Australian Rules football) in reducing excessive alcohol consumption by club members. Methods and analysis The study will be conducted in New South Wales, Australia, and employ a cluster randomised controlled trial design. Half of the football clubs recruited to the trial will be randomised to receive an intervention implemented over two and a half winter sporting seasons. The intervention is based on social ecology theory and is comprehensive in nature, containing multiple elements designed to decrease the supply of alcohol to intoxicated members, cease the provision of cheap and free alcohol, increase the availability and cost-attractiveness of non-alcoholic and low-alcoholic beverages, remove high alcohol drinks and cease drinking games. The intervention utilises a three-tiered accreditation framework designed to motivate intervention implementation. Football clubs in the control group will receive printed materials on topics unrelated to alcohol. Outcome data will be collected pre- and postintervention through cross-sectional telephone surveys of club members. The primary outcome measure will be alcohol consumption by club members at the club, assessed using a graduated frequency index and a seven day diary. Ethics and dissemination The study was approved by The University of Newcastle Human Research Ethics Committee (reference: H-2008-0432). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Trial registration number Australian New Zealand Clinical Trials Registry: ACTRN12609000224224. PMID:22021867

  1. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    PubMed Central

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences. Trial registration numbers Australia New Zealand Clinical Trials Registry—ACTRN12611000567921; National Institutes of Health—NCT02045121. PMID:25377015

  2. Guest Expert: Monica Bertagnolli, MD - Thoughts from the Group Chair of the Alliance for Clinical Trials in Oncology | accrualnet.cancer.gov

    Cancer.gov

    We are fortunate this month to have Dr. Monica Bertagnolli as our Guest Expert. Dr. Bertagnolli, the Group Chair of the Alliance for Clinical Trials in Oncology, has long been an unwavering advocate for clinical trial teamwork. Despite her official position as leader or chair of many national efforts, she seems to always know what’s going on in the trenches and to be willing to pitch in at any level. After reading Dr.

  3. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. Methods/design A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Discussion Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and would like to publish the results and conclusions later. If Qishe Pill can alleviate neck pain without adverse effects, it may be a unique strategy for the treatment of cervical radiculopathy. Trial registration This study is registered at ClinicalTrials.gov, NCT01274936 PMID:24099350

  4. Nursing Leadership of Successful Clinical Trial Recruitment Strategies to an NCCCP endorsed Study | accrualnet.cancer.gov

    Cancer.gov

    This study explores nursing leadership interventions for efficient trial accrual. The identified interventions resulted in successful screening and enrollment of appropriate patients to a chronic lymphocytic leukemia trial within a limited two-month enrollment timeframe.

  5. Multifactorial intervention for children with asthma and overweight (Mikado): study design of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background In children, the prevalence’s of both obesity and asthma are disconcertingly high. Asthmatic children with obesity are characterised by less asthma control and a high need for asthma medication. As the obese asthmatic child is becoming more common in the clinical setting and the disease burden of the asthma-obesity phenotype is high, there is an increasing need for effective treatment in these children. In adults, weight reduction resulted in improved lung function, better asthma control and less need for asthma medication. In children this is hardly studied. The Mikado study aims to evaluate the effectiveness of a long term multifactorial weight reduction intervention, on asthma characteristics in children with asthma and a high body weight. Methods/design The Mikado study is a two-armed, randomised controlled trial. In total, 104 participants will be recruited via online questionnaires, pulmonary paediatricians, the youth department of the Municipal Health Services and cohorts of existing studies. All participants will be aged 6–16?years, will have current asthma, a Body Mass Index in the overweight or obesity range, and no serious comorbidities (such as diabetes, heart diseases). Participants in the intervention arm will receive a multifactorial intervention of 18?months consisting of sessions concerning sports, parental involvement, individual counselling and lifestyle advices including dietary advices and cognitive behavioural therapy. The control group will receive usual care. The primary outcome variables will include Forced Expiratory Volume in one second and Body Mass Index - Standard Deviation Score. Secondary outcomes will include other lung function parameters (including dynamic and static lung function parameters), asthma control, asthma-specific quality of life, use of asthma medication and markers of systemic inflammation and airway inflammation. Discussion In this randomised controlled trial we will study the potential of a multifactorial weight reduction intervention to improve asthma-related outcome measures in asthmatic children with overweight. Moreover, it will provide information about the underlying mechanisms in the relationship between asthma and a high body weight in children. These findings can contribute to optimal management programs and better clinical guidelines for children with asthma and overweight. Trial registration Clinicaltrial.gov NCT00998413 PMID:23692648

  6. Use of participant focus groups to identify barriers and facilitators to worksite exercise therapy adherence in randomized controlled trials involving firefighters

    PubMed Central

    Mayer, John M; Nuzzo, James L; Dagenais, Simon

    2013-01-01

    Background Firefighters are at increased risk for back injuries, which may be mitigated through exercise therapy to increase trunk muscle endurance. However, long-term adherence to exercise therapy is generally poor, limiting its potential benefits. Focus groups can be used to identify key barriers and facilitators to exercise adherence among study participants. Objective To explore barriers and facilitators to worksite exercise therapy adherence among firefighters to inform future randomized controlled trials (RCTs). Methods Participants enrolled in a previous RCT requiring twice-weekly worksite exercise therapy for 24 weeks were asked to take part in moderated focus group discussions centered on eight open-ended questions related to exercise adherence. Responses were analyzed qualitatively using a social ecological framework to identify key intrapersonal, interpersonal, and institutional barriers and potential facilitators to exercise adherence. Results A total of 27 participants were included in the four focus group discussions, representing 50% of those assigned to a worksite exercise therapy group in the previous RCT, in which only 67% of scheduled exercise therapy sessions were completed. Lack of self-motivation was cited as the key intrapersonal barrier to adherence, while lack of peer support was the key interpersonal barrier reported, and lack of time to exercise during work shifts was the key institutional barrier identified. Conclusion Focus group discussions identified both key barriers and potential facilitators to increase worksite exercise therapy adherence among firefighters. Future studies should consider educating and reminding participants about the benefits of exercise, providing individual and group incentives based on exercise adherence and performance, providing outside monitoring of exercise adherence, varying the exercise routine, encouraging group exercise and competition, and scheduling exercise during each work shift. PMID:23515182

  7. Streamlining IRB review in multisite trials through single-study IRB Cooperative Agreements: experience of the Beta-Carotene and Retinol Efficacy Trial (CARET).

    PubMed

    Thornquist, Mark D; Edelstein, Cim; Goodman, Gary E; Omenn, Gilbert S

    2002-02-01

    With their extensive data and specimen repositories, clinical trials are a long-term, valuable resource to health researchers. However, assuring protection of participants' rights can be challenging, particularly when such trials are conducted at multiple sites with multiple Institutional Review Boards (IRBs). One little-used mechanism that can streamline IRB review in multisite trials while maintaining participants' protections is the single-study IRB Cooperative Agreement. This agreement is entirely different from reciprocity agreements between institutions. Beginning in 1996, the Beta-Carotene and Retinol Efficacy Trial established single-study IRB Cooperative Agreements among its performance sites, which reduced the average time to complete IRB approval from over 6 months to 1 month for each of many substudies. We describe our experience and make recommendations for other multisite clinical trials. PMID:11852169

  8. Environmental studies group. Annual report for 1978

    SciTech Connect

    Hunt, D. C.; Hurley, J. D.

    1980-08-21

    Group projects included radioecological studies of aquatic and terrestrial systems, land management activities, foodstuff monitoring, dust transport studies including fugitive dust measurements and modeling, and several support programs involving evaluation of the plant's ambient air samplers and airborne tritium monitoring techniques. Some salient results from the several project reports include determination of an appropriate model for mechanically generated fugitive dust dispersion, a radionuclide inventory of Smart Ditch Pond (Pond D-1), a coefficient of community determination for two terrestrial sample plots on the plant site buffer zone, a natality and mortality rate determination for fawns in the plant deer herd (including one positive coyote-kill determination), inlet loss and filter paper collection efficiencies for the plant ambient air samplers, and differential tritium sampling measurements of the vapor in Building 771 stack effluent.

  9. Bimatoprost versus latanoprost in lowering intraocular pressure in glaucoma and ocular hypertension: results from parallel-group comparison trials.

    PubMed

    Simmons, Steven T; Dirks, Monte S; Noecker, Robert J

    2004-01-01

    This review evaluated the clinical evidence of the comparative efficacy and safety of bimatoprost and latanoprost in lowering intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. Four head-to-head, randomized, and controlled clinical trials of bimatoprost and latanoprost with treatment periods ranging from 1 to 6 months were identified from searches of the MEDLINE database through February 2004. According to a review and comparison of the results, bimatoprost, when compared with latanoprost, was associated with greater mean reductions in IOP, greater mean increases in the percentage of patients demonstrating target IOP, and greater response rates. The differences between drugs were not always statistically significant. Overall, the between-group differences in mean IOP ranged from 0 to 1.5 mm Hg. In 92% of the IOP measurements, the mean IOP was lower among patients given bimatoprost than among those given latanoprost; in the remaining 8%, the IOP reduction was equal. Transient, mild conjunctival hyperemia was the most frequently reported adverse effect associated with either drug, but it occurred more frequently with bimatoprost. Overall, both drugs were well tolerated. As a 1-mm Hg change in IOP has been shown to reduce the risk of progression in patients with glaucoma (according to the Early Manifest Glaucoma Trial), the greater efficacy demonstrated by bimatoprost in lowering IOP may be clinically significant. PMID:15605619

  10. Parameters for Sample Size Estimation from a Group-Randomized HIV Prevention Trial in HIV Clinics in Sub-Saharan Africa

    PubMed Central

    Zhang, Jun; Pals, Sherri L.; Medley, Amy; Nichols, Catherine; Bachanas, Pam; van Zyl, Deon; Katuta, Frieda; Juma, James

    2015-01-01

    Sample size calculations for a group-randomized trial (GRT) require an estimate of the expected intraclass correlation coefficient (ICC). However, few ICC estimates from GRTs in HIV/AIDS research have been published, leaving investigators with little data on which to base expectations. We used data from a multi-country study to estimate ICCs for variables related to physical and mental health and HIV risk behaviors. ICCs for perceptions of physical and mental health tended to be higher than those for HIV risk behavior variables, which were higher than ICCs for CD4 count. Covariate adjustment for country and socio-demographic variables reduced most ICC estimates. For risk behavior variables, adjustment for country and socio-demographic variables reduced ICC estimates by as much as 84 %. Variability in ICC estimates has important implications for study design, as a larger ICC reduces power. ICC estimates presented in this analysis will allow more precise sample size estimates for future GRTs. PMID:24146070

  11. Symptom Control Trials in Patients With Advanced Cancer: A Qualitative Study

    PubMed Central

    Middlemiss, Tom; Lloyd-Williams, Mari; Laird, Barry J.; Fallon, Marie T.

    2015-01-01

    Context Symptom control research in patients with advanced cancer is not common. This may be the result of a belief that this research is unethical, not practical, or that patients are not interested. However, the experiences of cancer patients who have actually taken part in symptom control research near the end of life have never been detailed. Objectives The objective was to explore the experiences of patients with advanced cancer who had taken part in symptom control trials. Methods A prospective two-center study was undertaken using grounded theory methodology. Theoretical sampling was used to recruit patients from one of two double-blind, randomized, placebo-controlled trials studying novel analgesic agents for cancer-related pain. Participants completed one semistructured interview. Recruitment and interviewing continued until data saturation was achieved. Results Twenty-one participants were recruited. Fifteen (71%) were male, with a mean age of 62 years. Key themes identified included reasons for trial participation, participants' interactions with the trial staff, and participants' responses to the effect the trial had on their pain. In general, participants regarded taking part in a clinical trial as a positive experience, and potentially improving overall well-being. Crucially, this was not related to whether there had been an improvement in symptoms. Conclusion The findings provide grounds for optimism that patients with advanced cancer may benefit from taking part in symptom control trials, supporting the paradigm that participation in symptom control research should be encouraged in this population. PMID:26031710

  12. Tadalafil for Prevention of Erectile Dysfunction After Radiotherapy for Prostate Cancer The Radiation Therapy Oncology Group [0831] Randomized Clinical Trial

    PubMed Central

    Pisansky, Thomas M.; Pugh, Stephanie L.; Greenberg, Richard E.; Pervez, Nadeem; Reed, Daniel R.; Rosenthal, Seth A.; Mowat, Rex B.; Raben, Adam; Buyyounouski, Mark K.; Kachnic, Lisa A.; Bruner, Deborah W.

    2015-01-01

    IMPORTANCE Tadalafil is used to treat erectile dysfunction after prostate cancer treatment, but its role as a preventive agent is undefined. OBJECTIVES To determine primarily whether tadalafil preserved erectile function in men treated with radiotherapy for prostate cancer, and secondarily to determine whether participant- or partner-reported overall sexual function and sexual and marital satisfaction were affected. DESIGN, SETTING, AND PARTICIPANTS Stratified, placebo-controlled, double-blind, parallel-group study with 1:1 randomization at 76 community-based and tertiary medical sites in the United States and Canada. Two hundred forty-two participants with intact erectile function scheduled to receive radiotherapy for prostate cancer were recruited between November 2009 and February 2012 with follow-up through March 2013. INTERVENTIONS One hundred twenty-one participants were assigned 5 mg of tadalafil daily and 121 were assigned placebo for 24 weeks starting with external radiotherapy (63%) or brachytherapy (37%). Participant-reported International Index of Erectile Function response before radiotherapy and at weeks 2 and 4, between weeks 20 and 24, between weeks 28 and 30, and 1 year thereafter. Participants and partners could respond also to the Sexual Adjustment Questionnaire and to the Locke Marital Adjustment Test before radiotherapy, between weeks 20 and 24 and weeks 28 and 30, and at 1 year. MAIN OUTCOMES AND MEASURES Primary outcome was off-drug spontaneous erectile function 28 to 30 weeks after radiotherapy started. Secondary end points were spontaneous erection at 1 year; overall sexual function and satisfaction; marital adjustment; and partner-reported satisfaction and marital adjustment at 28 to 30 weeks and 1 year, predictors of tadalafil response; and adverse events. RESULTS Among 221 evaluable participants, 80 (79%; 95% CI, 70%–88%) assigned to receive tadalafil retained erectile function between weeks 28 and 30 compared with 61 (74%; 95% CI, 63%–85%) assigned to receive placebo (P = .49); an absolute difference of 5% (95% CI, ?9% to 19%). A significant difference was also not observed at 1 year (72%; 95% CI, 60%–84% vs 71%; 95% CI, 59%–84%; P = .93). Tadalafil was not associated with significantly improved overall sexual function or satisfaction; a significant difference was not observed in any domain subscale. Partners of men assigned tadalafil noted no significant effect on sexual satisfaction, and marital adjustment was not significantly improved in participants or partners. CONCLUSIONS AND RELEVANCE Amongmen undergoing radiotherapy for prostate cancer, daily use of tadalafil compared with placebo did not result in improved erectile function. These findings do not support daily use of tadalafil to prevent erectile dysfunction in these patients. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00931528 PMID:24691606

  13. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

    PubMed Central

    2013-01-01

    Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663 PMID:23374977

  14. The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Diabetes prevalence is increasing and current methods of management are unsustainable. Effective approaches to supporting self-management are required. The aim of this randomized controlled trial is to establish whether supported telemetric monitoring of glycemic control and blood pressure results in reductions in glycosylated hemoglobin (HbA1c; the primary outcome of a measure of long-term glycemic control) and secondary outcomes of blood pressure and weight among people with poorly controlled diabetes compared to a control group receiving usual care. Methods/Design Design: multi-center, randomized controlled trial with embedded qualitative study. Setting: primary care in Lothian, Kent, Glasgow and Borders regions in the UK. Participants: people with type 2 diabetes and confirmed HbA1c >7.5% (58 mmol/mol). Intervention/comparison: randomization to intervention or control groups will be performed by the Edinburgh Clinical Trials Unit. Participants in the intervention group will be shown how to use blood glucose and blood pressure monitors and weighing scales which use Bluetooth wireless technology to transmit readings via modem to a remote server. These participants will be asked to provide at least twice weekly measurements of morning and evening blood glucose and weekly measurements of weight and blood pressure. Measurements will be checked at least weekly by practice nurses who will contact the patients to adjust therapy according to guidelines and reinforce lifestyle advice. Participants in the control group will receive usual care. All participants will receive an individual education session. Follow-up: measurements will be performed at practices 9 months after randomization by research nurses blinded to allocation. The primary outcome measure is HbA1c and secondary outcomes measure are daytime systolic and diastolic blood pressure, weight and cost per quality-adjusted life year. Analysis: intention-to-treat analyses will be performed. The sample size of 320 participants allows for 20% drop-out and has 80% power at 5% significance to detect a 0.5% absolute (6 mmol/mol) fall in HbA1c in the intervention group. The qualitative study will explore the experiences of patients and professionals using the intervention. Trial registration Trial registration number ISRCTN71674628 PMID:23829417

  15. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease: III. The 2014 Biomarker Working Group Report

    PubMed Central

    Paczesny, Sophie; Hakim, Frances T.; Pidala, Joseph; Cooke, Kenneth; Lathrop, Julia; Griffith, Linda M.; Hansen, John; Jagasia, Madan; Miklos, David; Pavletic, Steven; Parkman, Robertson; Russek-Cohen, Estelle; Flowers, Mary E.D.; Lee, Stephanie; Martin, Paul; Vogelsang, Georgia; Walton, Marc; Schultz, Kirk R.

    2015-01-01

    Biology-based markers to confirm or aid in the diagnosis or prognosis of chronic GVHD after allogeneic hematopoietic cell transplantation (HCT) or monitor its progression are critically needed to facilitate evaluation of new therapies. Biomarkers have been defined as any characteristic that is objectively measured and evaluated as an indicator of a normal biological or pathogenic process, a pharmacologic response to a therapeutic intervention. Applications of biomarkers in chronic GVHD clinical trials or patient management include: a) diagnosis and assessment of chronic GVHD disease activity, including distinguishing irreversible damage from continued disease activity, b) prognostic risk to develop chronic GVHD, and c) prediction of response to therapy. Sample collection for chronic GVHD biomarkers studies should be well-documented following established quality control guidelines for sample acquisition, processing, preservation and testing, at intervals that are both calendar- and event-driven. The consistent therapeutic treatment of subjects and standardized documentation needed to support biomarker studies are most likely to be provided in prospective clinical trials. To date, no chronic GVHD biomarkers have been qualified for utilization in clinical applications. Since our previous chronic GVHD Biomarkers Working Group report in 2005, an increasing number of chronic GVHD candidate biomarkers are available for further investigation. This paper provides a four-part framework for biomarker investigations: identification, verification, qualification, and application with terminology based on Food and Drug Administration and European Medicines Agency guidelines. PMID:25644957

  16. Autism Spectrum Social Stories In Schools Trial (ASSSIST): study protocol for a feasibility randomised controlled trial analysing clinical and cost-effectiveness of Social Stories in mainstream schools

    PubMed Central

    Wright, Barry; Marshall, David; Collingridge Moore, Danielle; Ainsworth, Hannah; Hackney, Lisa; Adamson, Joy; Ali, Shehzad; Allgar, Victoria; Cook, Liz; Dyson, Lisa; Littlewood, Elizabeth; Hargate, Rebecca; McLaren, Anne; McMillan, Dean; Trépel, Dominic; Whitehead, Jo; Williams, Chris

    2014-01-01

    Introduction Current evidence suggests that Social Stories can be effective in tackling problem behaviours exhibited by children with autism spectrum disorder. Exploring the meaning of behaviour from a child's perspective allows stories to provide social information that is tailored to their needs. Case reports in children with autism have suggested that these stories can lead to a number of benefits including improvements in social interactions and choice making in educational settings. Methods and analysis The feasibility of clinical and cost-effectiveness of a Social Stories toolkit will be assessed using a randomised control framework. Participants (n=50) will be randomised to either the Social Stories intervention or a comparator group where they will be read standard stories for an equivalent amount of time. Statistics will be calculated for recruitment rates, follow-up rates and attrition. Economic analysis will determine appropriate measures of generic health and resource use categories for cost-effectiveness analysis. Qualitative analysis will ascertain information on perceptions about the feasibility and acceptability of the intervention. Ethics and dissemination National Health Service Ethics Approval (NHS; ref 11/YH/0340) for the trial protocol has been obtained along with NHS Research and Development permission from Leeds and York Partnership NHS Foundation Trust. All adverse events will be closely monitored, documented and reported to the study Data Monitoring Ethics Committee. At least one article in a peer reviewed journal will be published and research findings presented at relevant conferences. Trial registration number ISRCTN96286707. PMID:25009139

  17. Mediation and Spillover Effects in Group-Randomized Trials with Application to the 4Rs Evaluation

    ERIC Educational Resources Information Center

    VanderWeele, Tyler J.; Hong, Guanglei; Jones, Stephanie M.; Brown, Joshua L.

    2011-01-01

    In this paper the authors extend recent work on mediation in a multilevel setting and on causal inference under interference among units to develop a template for the mediation analysis of group randomized educational interventions. The present work will contribute to the literature on interference, in particular on interference in the context of…

  18. Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial

    PubMed Central

    Persson, Lars Åke; Nga, Nguyen T.; Målqvist, Mats; Thi Phuong Hoa, Dinh; Eriksson, Leif; Wallin, Lars; Selling, Katarina; Huy, Tran Q.; Duc, Duong M.; Tiep, Tran V.; Thi Thu Thuy, Vu; Ewald, Uwe

    2013-01-01

    Background Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam. Methods and Findings In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73–1.25]). There was a significant downward time trend of NMR in intervention communes (p?=?0.003) but not in control communes (p?=?0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30–0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07–4.8]). Conclusions A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period. Trial registration Current Controlled Trials ISRCTN44599712 Please see later in the article for the Editors' Summary PMID:23690755

  19. Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Schizophrenia is understood to be a heterogeneous brain condition with overlapping symptom dimensions. The negative symptom dimension, with its protean cognitive manifestations, responds poorly to treatment, which can be a particular challenge in countries where clozapine therapy is not available. Preliminary data indicate that minocycline may be beneficial adjunct in the treatment of schizophrenia: positive, negative, and cognitive symptoms. In this study we aim to assess the efficacy of adjunctive minocycline to alleviate symptoms of schizophrenia in patients who have failed to respond to a therapeutic trial of antipsychotic medications. Methods The study is a parallel group, double-blind, randomized, placebo-controlled trial. Participants will be adults (aged 18 years and above) with first episode or relapse episode of schizophrenia of under 5 years’ duration. Patients who failed to show adequate therapeutic response to at least one antipsychotic medication given for a minimum of 4 weeks will be recruited from a psychiatry hospital in Addis Ababa and a psychiatry clinic in Butajira, Ethiopia. A total of 150 participants (75 in each arm) will be required to detect a five-point mean difference between the intervention arms adjusting for baseline symptom severity, at 90% power and 95% confidence. Patients in the intervention arm will receive minocycline (200 mg/day orally) added on to the regular antipsychotic medications participants are already on. Those in the placebo arm will receive an inactive compound identical in physical appearance to minocycline. Intervention will be offered for 12 weeks. Diagnosis will be established using the operational criteria for research (OPCRIT). Primary outcome measure will be a change in symptom severity measured using the positive and the negative syndrome scale for schizophrenia (PANSS). Secondary outcome measures will include changes in severity of negative symptoms, proportion achieving remission, and level of functioning. Whether changes are maintained post intervention will also be measured (PANSS). Key assessment for the primary outcome will be conducted at the end of trial (week 12). One post-intervention assessment will be conducted 4 weeks after the end of intervention (week 16) to determine sustainability of change. Trial registration Clinicaltrials.gov identifier: NCT01809158. PMID:24279305

  20. Clinical effect of catgut implantation at acupoints for allergic rhinitis: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Catgut implantation at acupoints has been used in China to treat allergic rhinitis (AR) for a long time. However, its efficacy and safety in the treatment of AR is controversial due to the poor quality of the clinical trial of this therapy. This study aims to identify whether catgut implantation at acupoints is indeed an effective and safe treatment for patients with persistent or intermittent allergic rhinitis (PER or IAR) by comparing with sham catgut implantation treatment. Methods and design This study compares real versus sham catgut implantation at acupoints in 242 patients with a history of PER or IAR and with a positive skin prick test (SPT). The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine. In the study, patients will be randomly assigned by computer-generated randomization list into two groups and assessed prior to treatment. Then, they will receive two sessions of treatments (once per 2 weeks) for 4 consecutive weeks and have a follow-up phase of 12 weeks. The administration of catgut implantation (or sham-control) at acupoints follows the guidelines for clinical research on acupuncture (WHO Regional Publication, Western Pacific Series No.15, 1995), and is performed double-blindly by a well-trained physician in acupuncture. The main outcome measures include the primary and secondary indicators. Primary indicators are subjective symptoms scores evaluated by visual analogue scales (VAS) and Rhinoconjunctivitis Quality of Life Questionnaires (RQLQ). The secondary indicators are the results of laboratory examinations, such as serum allergen-specific IgE, nasal inflammatory cells counts (mast cells, eosinophils, and T cells) and nitric oxide concentration in nasal excretion. The use of anti-allergic medication will also be recorded as one of the secondary indicators. Furthermore, adverse events will be recorded and analyzed. If any participants withdraw from the trial, intention-to-treat analysis (ITT) and per-protocol (PP) analysis will be performed. Discussion The important features of this trial include the randomization procedures, large sample, and a standardized protocol of catgut implantation at acupoints. This trial will be the first study with a high evidence level in China in order to assess the efficacy and safety of catgut implantation at acupoints in treatment of AR following a randomized, double-blind sham-controlled method. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002191 PMID:23302264

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

    PubMed Central

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

    2013-01-01

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

  2. 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

  3. Study protocol: münster tinnitus randomized controlled clinical trial-2013 based on tailor-made notched music training (TMNMT)

    PubMed Central

    2014-01-01

    Background Tinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency, which has developed to synchronous mass activity owing the lack of inhibition. We assume that removal of exactly these frequency components from an auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency. Based on this assumption a novel treatment for tonal tinnitus - tailor-made notched music training (TMNMT) (Proc Natl Acad Sci USA 107:1207–1210, 2010; Ann N Y Acad Sci 1252:253–258, 2012; Frontiers Syst Neurosci 6:50, 2012) has been introduced and will be tested in this clinical trial on a large number of tinnitus patients. Methods and design A randomized controlled trial (RCT) in parallel group design will be performed in a double-blinded manner. The choice of the intervention we are going to apply is based on two “proof of concept” studies in humans (Proc Natl Acad Sci USA 107:1207–1210, 2010; Ann N Y Acad Sci 1252:253–258, 2012; Frontiers Syst Neurosci 6:50, 2012; PloS One 6(9):e24685, 2011) and on a recent animal study (Front Syst Neurosci 7:21, 2013). The RCT includes 100 participants with chronic, tonal tinnitus who listened to tailor-made notched music (TMNM) for two hours a day for three months. The effect of TMNMT is assessed by the tinnitus handicap questionnaire and visual analogue scales (VAS) measuring perceived tinnitus loudness, distress and handicap. Discussion This is the first randomized controlled trial applying TMNMT on a larger number of patients with tonal tinnitus. Our data will verify more securely and reliably the effectiveness of this kind of completely non-invasive and low-cost treatment approach on tonal tinnitus. Trial registration Current Controlled Trials ISRCTN04840953 PMID:24581050

  4. Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy: study protocol for a randomised trial

    PubMed Central

    Munteanu, Shannon E; Landorf, Karl B; Menz, Hylton B; Cook, Jill L; Pizzari, Tania; Scott, Lisa A

    2009-01-01

    Background Achilles tendinopathy is a common condition that can cause marked pain and disability. Numerous non-surgical treatments have been proposed for the treatment of this condition, but many of these treatments have a poor or non-existent evidence base. The exception to this is eccentric calf muscle exercises, which have become a standard non-surgical intervention for Achilles tendinopathy. Foot orthoses have also been advocated as a treatment for Achilles tendinopathy, but the long-term efficacy of foot orthoses for this condition is unknown. This manuscript describes the design of a randomised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy. Methods One hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy (who satisfy inclusion and exclusion criteria) will be recruited. Participants will be randomised, using a computer-generated random number sequence, to either a control group (sham foot orthoses made from compressible ethylene vinyl acetate foam) or an experimental group (customised foot orthoses made from semi-rigid polypropylene). Both groups will be prescribed a calf muscle eccentric exercise program, however, the primary difference between the groups will be that the experimental group receive customised foot orthoses, while the control group receive sham foot orthoses. The participants will be instructed to perform eccentric exercises 2 times per day, 7 days per week, for 12 weeks. The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire. The secondary outcome measures will be participant perception of treatment effect, comfort of the foot orthoses, use of co-interventions, frequency and severity of adverse events, level of physical activity and health-related quality of life (assessed using the Short-Form-36 questionnaire - Version two). Data will be collected at baseline, then at 1, 3, 6 and 12 months. Data will be analysed using the intention to treat principle. Discussion This study is the first randomised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy. The study has been pragmatically designed to ensure that the study findings are generalisable to clinical practice. Trial registration Australian New Zealand Clinical Trials Registry Number: ACTRN12609000829213. PMID:19852853

  5. The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population. Methods/Design This is a single-centre randomized controlled parallel group trial, in a British university hospital.Randomization is achieved using a website and computer-generated concealed tables. Participants are 80 patients 70 years or over with acute hip fracture undergoing operative repair. The intervention group receive three daily infusions of 200 mg iron sucrose, starting within 24 hours of admission. The control group receive standard hospital care at the discretion of the clinical team. Red cell transfusions for each group are given in accordance with standard clinical triggers. The primary outcome is an increase in mean reticulocyte count in the intervention group at day 7. Secondary outcome measures include haemoglobin concentrations, early and late transfusion rates, infectious and cardiovascular complications, mobility and 30-day mortality. Discussion This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron. Trial registration Current Controlled Trials ISRCTN76424792; UK Medicines and Healthcare products Regulatory Authority (EuDRACT: 2011-003233-34). PMID:24015990

  6. Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

    PubMed Central

    2012-01-01

    Background The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation. Methods The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance. Results Intervention participants significantly improved at 12 months in mean body mass index (?0.98 kg/m2, standard error (SE)?=?0.26), weight (?2.65 kg, SE?=?0.72), waist circumference (?7.45 cm, SE?=?1.15), and systolic blood pressure (?3.18 mmHg, SE?=?1.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE?=?0.03), reduced energy from total (?2.00%, SE?=?0.78) and saturated fat (?1.54%, SE?=?0.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE?=?0.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE?=?0.27). Only waist circumference reduced significantly (?4.02 cm, SE?=?0.95). Intervention participants significantly outperformed controls over 12 months for body mass index and fibre intake. After baseline adjustment, they also showed greater weight loss and reduced saturated fat versus total energy intake. At least 5% weight loss was achieved by 32% of intervention participants versus 0% controls. Conclusions pMDPS results indicate that scaling-up from implementation trial to state-wide programme is possible. The system design for Life! was fit for purpose of scaling-up from efficacy to effectiveness. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000507280 PMID:22929458

  7. Mayo's Older Americans Normative Studies: expanded AVLT Recognition Trial norms for ages 57 to 98.

    PubMed

    Harris, Milton E; Ivnik, Robert J; Smith, Glenn E

    2002-04-01

    This paper expands upon previously published Mayo's Older Americans Normative Studies (MOANS) Auditory Verbal Learning Test (AVLT) norms by presenting age and gender specific data for Recognition Trial accuracy (recognition 'hits' corrected for false positive errors) in a total of 836 subjects (the original sample, augmented by an additional 311 subjects). Observations are offered concerning clinical implications of AVLT Recognition Trial performance. Gender differences in recognition memory are discussed. PMID:11992204

  8. A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study)

    PubMed Central

    2011-01-01

    Background Irritable Bowel Syndrome (IBS) is a common gastro-intestinal disorder in primary and secondary care, characterised by abdominal pain, discomfort, altered bowel habits and/or symptoms of bloating and distension. In general the efficacy of drug therapies is poor. Hypnotherapy as well as Cognitive Behaviour Therapy and short Psychodynamic Therapy appear to be useful options for patients with refractory IBS in secondary care and are cost-effective, but the evidence is still limited. The IMAGINE-study is therefore designed to assess the overall benefit of hypnotherapy in IBS as well as comparing the efficacy of individual versus group hypnotherapy in treating this condition. Methods/Design The design is a randomised placebo-controlled trial. The study group consists of 354 primary care and secondary care patients (aged 18-65) with IBS (Rome-III criteria). Patients will be randomly allocated to either 6 sessions of individual hypnotherapy, 6 sessions of group hypnotherapy or 6 sessions of educational supportive therapy in a group (placebo), with a follow up of 9 months post treatment for all patients. Ten hospitals and four primary care psychological practices in different parts of The Netherlands will collaborate in this study. The primary efficacy parameter is the responder rate for adequate relief of IBS symptoms. Secondary efficacy parameters are changes in the IBS symptom severity, quality of life, cognitions, psychological complaints, self-efficacy as well as direct and indirect costs of the condition. Hypnotherapy is expected to be more effective than the control therapy, and group hypnotherapy is expected not to be inferior to individual hypnotherapy. Discussion If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypnotherapy, this group form of treatment could be offered to more IBS patients, at lower costs. Trial registration number ISRCTN: ISRCTN22888906 PMID:22185606

  9. South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study

    PubMed Central

    Samaan, Zainab; Schulze, Karleen M; Middleton, Catherine; Irvine, Jane; Joseph, Phillip; Mente, Andrew; Shah, Baiju R; Pare, Guillaume; Desai, Dipika

    2013-01-01

    Background People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary. Objective Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports. Methods The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines. Results The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of the participants could not recall their risk scores at the end of study evaluation. Some components of the multimedia intervention were not widely used such as logging onto the website to set new health goals, and participants requested having more personal interactions with the study team. Conclusions Some, but not all, components of the multimedia intervention are feasible and have the potential to induce positive health behavior changes. MI and GRS reports are desired by participants although their impact on inducing sustained health behavior change requires further evaluation. Information generated from this pilot study has directly informed the design of another randomized trial designed to reduce MI risk among South Asians. Trial Registration ClinicalTrials.gov NCT01577719; http://clinicaltrials.gov/ct2/show/NCT01577719 (Archived by WebCite at http://www.webcitation.org/6J11uYXgJ). PMID:23965279

  10. Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial

    PubMed Central

    2013-01-01

    Background Menstrual-related migraine is a common form of migraine affecting >50% of female migraineurs. Acupuncture may be a choice for menstrual-related migraine, when pharmacological prophylaxis is not suitable. However, the efficacy of acupuncture has not been confirmed. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with naproxen in menstrual-related migraine patients. Methods/Design This is a multicenter, single blind, randomized controlled clinical trial. A total of 184 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and medicine (Naproxen Sustained Release Tablets). All treatments will be given for 3 months (menstrual cycles). The primary outcome measures are the change of migraine days inside the menstrual cycle and the proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days). The secondary outcome measures are the change of migraine days outside the menstrual cycle, duration of migraine attack, the Visual Analogue Scale (VAS), and intake of acute medication. The assessment will be made at baseline (before treatment), 3 months (menstrual cycles), and 4 months (menstrual cycles) after the first acupuncture session. Discussion The results of this trial will be helpful to supply the efficacy of acupuncture for menstrual-related migraine prophylaxis. Trial registration ISRCTN: ISRCTN57133712 PMID:24195839

  11. Examination of early group dynamics and treatment outcome in a randomized controlled trial of group cognitive behavior therapy for binge eating disorder.

    PubMed

    Pisetsky, Emily M; Durkin, Nora E; Crosby, Ross D; Berg, Kelly C; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2015-10-01

    This study examined whether perceptions of group dynamics early in treatment predicted eating disorder outcomes in a sample of adults (N = 190) with binge eating disorder (BED) who participated in a 15-session group cognitive behavior therapy (gCBT) treatment with differing levels of therapist involvement (therapist led, therapist assisted, and self-help). The group dynamic variables included the Engaged subscale of the Group Climate Questionnaire - Short Form and the Group Attitude Scale, measured at session 2 and session 6. Treatment outcome was assessed in terms of global eating disorder severity and frequency of binge eating at end of treatment, 6-month, and 12-month follow-up. Session 2 engagement and group attitudes were associated with improved outcome at 12-month follow-up. No other group dynamic variables were significantly associated with treatment outcome. Group dynamic variables did not differ by levels of therapist involvement. Results indicate that early engagement and attitudes may be predictive of improved eating disorder psychopathology at 12 month follow-up. However, the pattern of mostly insignificant findings indicates that in gCBT, group process variables may be less influential on outcomes relative to other treatment components. Additionally, participants were able to engage in group treatment regardless of level of therapist involvement. PMID:26264648

  12. Feasibility of double-blind clinical trials with oral diacetylmorphine: a randomized controlled phase II study in an inpatient setting.

    PubMed

    Colom Farran, Joan; Casas, Miguel; Pérez de Los Cobos, José; Del Río, Miquel; Roncero, Carlos; Castells, Xavier; Valero, Sergi; Eiroa-Orosa, Francisco José; Batlle, Francisca; Trujols, Joan

    2012-01-01

    The aim of this study was to evaluate the feasibility of conducting double-blind controlled randomized clinical trials using twice-a-day immediate-release oral diacetylmorphine (DAM) in heroin-dependent patients, by means of measuring the capacity of oral DAM to block opiate withdrawal and clinicians' ability to distinguish it from morphine and methadone. This was a randomized, phase II, double-blind, multicenter pilot study comparing immediate-release oral DAM, slow-release oral morphine and oral methadone administered twice a day during 10 days. Forty-five heroin-dependent patients were randomly assigned to these three treatment groups in an inpatient regime. Patients were stabilized with a mean of 350 mg (SD = 193) of immediate-release oral DAM, 108 mg (SD = 46.2) of slow-release oral morphine and 40 mg (SD = 17.9) of methadone. No statistically significant differences were found between any studied medication in clinical outcome. Neither patients nor clinicians were able to identify the administered medication. This study shows the feasibility of double-blind clinical trials using b.i.d. immediate-release oral DAM allowing further phase III clinical trials in the process of introducing oral DAM as a medication for heroin-dependent patients not responding to standard maintenance treatments. PMID:22854605

  13. Watching MOOCs Together: Investigating Co-Located MOOC Study Groups

    ERIC Educational Resources Information Center

    Li, Nan; Verma, Himanshu; Skevi, Afroditi; Zufferey, Guillaume; Blom, Jan; Dillenbourg, Pierre

    2014-01-01

    Research suggests that massive open online course (MOOC) students prefer to study in groups, and that social facilitation within the study groups may render the learning of difficult concepts a pleasing experience. We report on a longitudinal study that investigates how co-located study groups watch and study MOOC videos together. The study was…

  14. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be analyzed. Discussion Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients. Trial registration This study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466. PMID:24746224

  15. Occurrence and determinants of selective reporting of clinical drug trials: design of an inception cohort study

    PubMed Central

    van den Bogert, Cornelis A; Souverein, Patrick C; Brekelmans, Cecile T M; Janssen, Susan W J; van Hunnik, Manon; Koëter, Gerard H; Leufkens, Hubertus G M; Bouter, Lex M

    2015-01-01

    Introduction Responsible conduct of research implies that results of clinical trials should be completely and adequately reported. This article describes the design of a cohort study that aims to investigate the occurrence and the determinants of selective reporting in an inception cohort of all clinical drug trials that were reviewed by the Dutch Institutional Review Boards (IRBs) in 2007. It also describes the characteristics of the study cohort. Methods and analysis In 2007, Dutch IRBs reviewed 622 clinical drug trials. For each trial, we assessed the stages of progress. We discriminated five intermediate stages and five definite stages. Intermediate stages of progress are: approved by an IRB; started inclusion; completed as planned; terminated early; published as article. The definite stages of progress are: rejected by an IRB; never started inclusion; not published as article; completely reported; selectively reported. We will use univariate and multivariate Cox regression models to identify trial characteristics associated with non-publication. We will identify seven trial-specific discrepancy items, including the objectives, inclusion and exclusion criteria, end points, sample size, additional analyses, type of population analysis and sponsor acknowledgement. The percentage of trials with discrepancies between the protocol and the publication will be scored. We will investigate the association between trial characteristics and the occurrence of discrepancies. Ethics and dissemination No IRB-approval is required for this study. Access to confidential research protocols was provided by the Central Committee on Research Involving Human Subjects. We plan to finish data collection in June 2015, and expect to complete data cleaning, analysis and manuscript preparation within the next 3?months. Hence, a first draft of an article containing the results is expected before the end of October 2015. PMID:26152325

  16. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study. | accrualnet.cancer.gov

    Cancer.gov

    The authors conducted interviews of individuals with asymptomatic atherosclerosis who declined participation in an aspirin-versus-placebo prevention trial or stopped participating before the trial ended. Both groups cited two types of reasons for nonparticipation. Some were not convinced of the necessity of the trial or did not feel that their condition required preventive treatment. Others were concerned about risk, in terms of both the effects of randomization and the possibility of side effects.

  17. Internet-delivered cognitive behaviour therapy for depression in people with diabetes: study protocol for a randomised controlled trial

    PubMed Central

    Robins, Lisa; Newby, Jill; Wilhelm, Kay; Smith, Jessica; Fletcher, Therese; Ma, Trevor; Finch, Adam; Campbell, Lesley; Andrews, Gavin

    2015-01-01

    Introduction Depression substantially contributes to the personal burden and healthcare costs of living with diabetes mellitus (DM). Comorbid depression and DM are associated with poorer quality of life, poorer self-management and glycemic control, increased risk for DM complications and higher mortality rates, and higher health service utilization. Depression remains under-recognized and undertreated in people with DM, which may, in part, result from barriers associated with accessing face-to-face treatment. This study will examine the efficacy of an internet-based cognitive behaviour therapy programme for major depressive disorder (iCBT-MDD) in people with DM. Methods and analysis A CONSORT 2010 compliant, registered randomised controlled trial of the intervention (iCBT-MDD) versus a treatment as usual control group will be conducted. The study will include 100 adults aged 18?years and over with a diagnosis of type 1 or type 2 DM and self-reported symptoms that satisfy MDD which will enable us to detect a statistically significant difference with a group effect size of 0.6 at a power of 80% and significance level of p=0.05. Participants will be randomised to receive the iCBT-MDD programme immediately, or to wait 10?weeks before accessing the programme. Primary outcomes will be self-reported depression severity, DM-related distress, and glycemic control (glycosylated hemoglobin). Secondary outcomes will be general distress and disability, generalized anxiety, lifestyle behaviours, somatization, eating habits, alcohol use, and acceptability of the iCBT programme to participants, and practicality for clinicians. Data will be analyzed with linear mixed models for each outcome measure. Ethics and dissemination The Human Research Ethics Committee of St Vincent's Hospital Australia have given ethics approval (HREC/13/SVH/291). Results will be disseminated via peer-reviewed publication and social media channels of Australian Diabetes Consumer Representative Bodies. Trial registration number The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12613001198718). PMID:26688735

  18. Usefulness of interim analyses in portending study results in antipsychotic and antidepressant trials.

    PubMed

    Rabinowitz, J; Werbeloff, N; Mandel, F; De Ridder, F; Schacht, A; Menard, F; Caears, I; Stauffer, V; Kapur, S

    2015-11-01

    It is unknown whether interim analyses portend final study results. Fatigue, pressure to complete trials and recruitment differences may mitigate against this. We examined the similarity of efficacy results of the first and second half of recruited patients to complete trials and explore possible intervening variables. Using data from the NewMeds repository of patient level data from placebo-controlled randomized trials of antipsychotics (AP) (22 studies, n=7056) and antidepressants (AD) (39 studies, n=12,217) we compared treatment effect size (placebo vs. active treatment) of the first and second half of patients recruited in completed trials. We found that in AP studies median difference in treatment effect between cohorts was -0.03, indicating that overall first and second cohorts yielded similar results. In AD studies, median difference between cohorts was 0.04, indicating that overall the second cohort had slightly larger active-placebo-difference. Overall, on average there were minimal differences in effect size between the first and the second cohorts, and in 30 of 39 trials interim results were a good estimate of the results on the 2nd cohort. In AD trials first and second cohort results were more similar when the proportion of patients per study centre and recruitment time of the two cohorts was similar. Results suggest that interim analyses in AD and AP studies may reliably serve to estimate ultimate effects and, at least in AD trials, are more accurate when the same sites are used to a similar extent and recruitment time of the two consequent cohorts is similar. PMID:26256009

  19. Meaning-centered group psychotherapy for patients with advanced cancer: a pilot randomized controlled trial

    PubMed Central

    Breitbart, William; Rosenfeld, Barry; Gibson, Christopher; Pessin, Hayley; Poppito, Shannon; Nelson, Christian; Tomarken, Alexis; Timm, Anne Kosinski; Berg, Amy; Jacobson, Colleen; Sorger, Brooke; Abbey, Jennifer; Olden, Megan

    2013-01-01

    Objectives An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. Methods Patients with advanced (stage III or IV) solid tumor cancers (N = 90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. Results MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. Conclusions MCGP appears to be a potentially beneficial intervention for patients’ emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention. PMID:19274623

  20. Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial

    PubMed Central

    2013-01-01

    Background In pressure support ventilation (PSV), a non-variable level of pressure support is delivered by the ventilator when triggered by the patient. In contrast, variable PSV delivers a level of pressure support that varies in a random fashion, introducing more physiological variability to the respiratory pattern. Experimental studies show that variable PSV improves gas exchange, reduces lung inflammation and the mean pressure support, compared to non-variable PSV. Thus, it can theoretically shorten weaning from the mechanical ventilator. Methods/design The ViPS (variable pressure support) trial is an international investigator-initiated multicenter randomized controlled open trial comparing variable vs. non-variable PSV. Adult patients on controlled mechanical ventilation for more than 24 hours who are ready to be weaned are eligible for the study. The randomization sequence is blocked per center and performed using a web-based platform. Patients are randomly assigned to one of the two groups: variable PSV or non-variable PSV. In non-variable PSV, breath-by-breath pressure support is kept constant and targeted to achieve a tidal volume of 6 to 8 ml/kg. In variable PSV, the mean pressure support level over a specific time period is targeted at the same mean tidal volume as non-variable PSV, but individual levels vary randomly breath-by-breath. The primary endpoint of the trial is the time to successful weaning, defined as the time from randomization to successful extubation. Discussion ViPS is the first randomized controlled trial investigating whether variable, compared to non-variable PSV, shortens the duration of weaning from mechanical ventilation in a mixed population of critically ill patients. This trial aims to determine the role of variable PSV in the intensive care unit. Trial registration clinicaltrials.gov NCT01769053 PMID:24176188

  1. Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial

    PubMed Central

    Lee, Hye-Yoon; Nam, Jong-Kil; Lee, Sang-Don; Lee, Dong-Hoon; Han, Ji-Yeon; Yun, Young-Ju; Lee, Ji-Hye; Park, Hye-lim; Park, Seong-Ha; Kwon, Jung-Nam

    2015-01-01

    Introduction This study aims to explore the feasibility of using moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostatic hyperplasia accompanying moderate to severe lower urinary tract symptoms. Methods and analysis A total of 60 patients diagnosed with benign prostatic hyperplasia by a urologist based on prostate size, prostate-specific antigen and clinical symptoms will participate of their own free will; urologists will monitor the patients and evaluate their symptoms. The patients will be randomised to either a conventional group or an integrative group with a 1:1 allocation according to computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. Watchful waiting or oral medication including ? blocker, 5?-reductase inhibitors or antimuscarinic drugs will be offered as conventional treatment. Integrative treatment will include moxibustion therapy in addition to the conventional treatment. The moxibustion therapy will be conducted twice a week for 4?weeks on the bilateral acupoints SP6, LR3 and CV4 by a qualified Korean medical doctor. The primary outcome will be the International Prostate Symptom Score (IPSS) after eight sessions. The secondary outcomes will be the post-void residual urine volume, the maximum urinary flow rate, IPSS, the results of a Short-Form 36-Question Health Survey after 12?weeks, and the patients’ global impression of changes at each visit. Ethics and dissemination Written informed consent will be obtained from all participants. This study was approved by the institutional review boards of both Pusan National University Yangsan Hospital and Pusan National University Korean Medicine Hospital. The trial results will be disseminated through open-access journals and conferences. Trial registration number NCT02051036. PMID:26656981

  2. Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study

    PubMed Central

    2012-01-01

    Background Telehealth (TH) and telecare (TC) interventions are increasingly valued for supporting self-care in ageing populations; however, evaluation studies often report high rates of non-participation that are not well understood. This paper reports from a qualitative study nested within a large randomised controlled trial in the UK: the Whole System Demonstrator (WSD) project. It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial. Methods Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention (n?=?19), or who withdrew from the intervention arm (n?=?3). Participants were recruited from the four trial groups (with diabetes, chronic obstructive pulmonary disease, heart failure, or social care needs); and all came from the three trial areas (Cornwall, Kent, east London). Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home. Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes. Results Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes: requirements for technical competence and operation of equipment; threats to identity, independence and self-care; expectations and experiences of disruption to services. Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderstandings. Respondents’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance, and views that interventions could undermine self-care and coping. Finally, participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued. Conclusions These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake. These insights have implications for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction. It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation. PMID:22834978

  3. Pylorus resection or pylorus preservation in partial pancreatico-duodenectomy (PROPP study): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Partial pancreatico-duodenectomy (PD) is the standard treatment for tumors of the pancreatic head. Today, preservation of the pylorus has been widely accepted as the surgical standard in this procedure. A common postoperative complication is the occurrence of delayed gastric emptying (DGE), which causes impairment of oral intake andpatients’ quality of life, prolongation of hospital stay and delay of further treatment (for example adjuvant chemotherapy). In a small number of two retrospective and one randomized studies, a modification by resection of the pylorus with preservation of the stomach has shown to reduce DGE incidence. The aim of the present study is to investigate the effect of pylorus resection on postoperative DGE in PD. Methods/Design Patients undergoing elective PD for any indication equal or older than 18 years and who have given informed consent will be included. Patients will be randomized to either PD with pylorus preservation or PD with pylorus resection and complete stomach preservation. Sample size (n?=?89 patients per group) is calculated on an assumed difference in DGE incidence of 20%. Primary study endpoint is DGE within 30 days; secondary endpoints are operation time, blood loss, morbidity, mortality, hospital stay and quality of life (QoL). Discussion DGE is a relevant clinical problem following PD with a great impact on patients’ recovery, length of hospital stay, QoL and consecutive adjuvant therapies. As there is no causal therapy, prevention of DGE is essential to improve outcome. The technical modification of pylorus resection may offer a simple and effective method for this purpose. The present study is designed to increase the existing body of evidence and potentially change the future standard surgical procedure of PD. Trial registration German Clinical Trials Register DRKS00004191. PMID:23410208

  4. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial

    PubMed Central

    2014-01-01

    Background Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening. Methods/Design An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected. Discussion This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting. Trial registration ClinicalTrials.gov Identifier: NCT01739608 PMID:24678896

  5. Consent for Genetics Studies Among Clinical Trial Participants: Findings from Action for Health in Diabetes (Look AHEAD)

    PubMed Central

    Espeland, Mark A.; Dotson, Kathy; Jaramillo, Sarah A.; Kahn, Steven E.; Harrison, Barbara; Montez, Maria; Foreyt, John P.; Montgomery, Brenda; Knowler, William C.

    2008-01-01

    Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression, or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated, or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes, and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships. PMID:17060218

  6. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Social anxiety disorder (SAD) is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT) has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96) will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a) an active treatment, or b) a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention). Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR) will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894 PMID:23111108

  7. Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).

    PubMed

    Barosi, G; Tefferi, A; Besses, C; Birgegard, G; Cervantes, F; Finazzi, G; Gisslinger, H; Griesshammer, M; Harrison, C; Hehlmann, R; Hermouet, S; Kiladjian, J-J; Kröger, N; Mesa, R; Mc Mullin, M F; Pardanani, A; Passamonti, F; Samuelsson, J; Vannucchi, A M; Reiter, A; Silver, R T; Verstovsek, S; Tognoni, G; Barbui, T

    2015-01-01

    The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-negative myeloproliferative neoplasms (MPNs) has generated interest in the development of molecularly targeted therapies, whose accurate assessment requires a standardized framework. A working group, comprised of members from European LeukemiaNet (ELN) and International Working Group for MPN Research and Treatment (IWG-MRT), prepared consensus-based recommendations regarding trial design, patient selection and definition of relevant end points. Accordingly, a response able to capture the long-term effect of the drug should be selected as the end point of phase II trials aimed at developing new drugs for MPNs. A time-to-event, such as overall survival, or progression-free survival or both, as co-primary end points, should measure efficacy in phase III studies. New drugs should be tested for preventing disease progression in myelofibrosis patients with early disease in randomized studies, and a time to event, such as progression-free or event-free survival should be the primary end point. Phase III trials aimed at preventing vascular events in polycythemia vera and essential thrombocythemia should be based on a selection of the target population based on new prognostic factors, including JAK2 mutation. In conclusion, we recommended a format for clinical trials in MPNs that facilitates communication between academic investigators, regulatory agencies and drug companies. PMID:25151955

  8. Investigating the efficacy of integrated cognitive behavioral therapy for adult treatment seeking substance use disorder patients with comorbid ADHD: study protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Attention deficit hyperactivity disorder (ADHD) frequently co-occurs with substance use disorders (SUD). The combination of ADHD and SUD is associated with a negative prognosis of both SUD and ADHD. Pharmacological treatments of comorbid ADHD in adult patients with SUD have not been very successful. Recent studies show positive effects of cognitive behavioral therapy (CBT) in ADHD patients without SUD, but CBT has not been studied in ADHD patients with comorbid SUD. Methods/design This paper presents the protocol of a randomized controlled trial to test the efficacy of an integrated CBT protocol aimed at reducing SUD as well as ADHD symptoms in SUD patients with a comorbid diagnosis of ADHD. The experimental group receives 15 CBT sessions directed at symptom reduction of SUD as well as ADHD. The control group receives treatment as usual, i.e. 10 CBT sessions directed at symptom reduction of SUD only. The primary outcome is the level of self-reported ADHD symptoms. Secondary outcomes include measures of substance use, depression and anxiety, quality of life, health care consumption and neuropsychological functions. Discussion This is the first randomized controlled trial to test the efficacy of an integrated CBT protocol for adult SUD patients with a comorbid diagnosis of ADHD. The rationale for the trial, the design, and the strengths and limitations of the study are discussed. Trial registration This trial is registered in http://www.clinicaltrials.gov as NCT01431235. PMID:23663651

  9. Healthy Families Study: Design of a Childhood Obesity Prevention Trial for Hispanic Families

    PubMed Central

    Zoorob, Roger; Buchowski, Maciej; Beech, Bettina M.; Canedo, Juan R.; Chandrasekhar, Rameela; Akohoue, Sylvie; Hull, Pamela C.

    2013-01-01

    Background The childhood obesity epidemic disproportionately affects Hispanics. This paper reports on the design of the ongoing Healthy Families Study, a randomized controlled trial testing the efficacy of a community-based, behavioral family intervention to prevent excessive weight gain in Hispanic children using a community-based participatory research approach. Methods The study will enroll 272 Hispanic families with children ages 5–7 residing in greater Nashville, Tennessee, United States. Families are randomized to the active weight gain prevention intervention or an alternative intervention focused on oral health. Lay community health promoters implement the interventions primarily in Spanish in a community center. The active intervention was adapted from the We Can! parent program to be culturally-targeted for Hispanic families and for younger children. This 12-month intervention promotes healthy eating behaviors, increased physical activity, and decreased sedentary behavior, with an emphasis on parental modeling and experiential learning for children. Families attend eight bi-monthly group sessions during four months then receive information and/or support by phone or mail each month for eight months. The primary outcome is change in children’s body mass index. Secondary outcomes are changes in children’s waist circumference, dietary behaviors, preferences for fruits and vegetables, physical activity, and screen time. Results Enrollment and data collection are in progress. Conclusion This study will contribute valuable evidence on efficacy of a childhood obesity prevention intervention targeting Hispanic families with implications for reducing disparities. PMID:23624172

  10. Factors that Contribute in the First Hookah Smoking Trial by Women: A Qualitative Study from Iran

    PubMed Central

    BAHEIRAEI, Azam; SHAHBAZI SIGHALDEH, Shirin; EBADI, Abbas; KELISHADI, Roya; MAJDZADEH, Reza

    2015-01-01

    Abstract Background Hookah smoking is growing in popularity especially among women but little is known about the determinants influencing on hookah smoking initiation. In order to address this emerging health risk, a qualitative study was conducted to explore the factors that contribute in the first hookah smoking trial by women. Methods This qualitative study was conducted during 2012 to 2013 in Tehran, Iran. Participants were recruited to represent diversity in smoking status, ethnicity, age groups and residence. Data was collected through in-depth individual interviews and was analyzed through content analysis. Results Four main themes were identified from the qualitative data including: Positive attitude toward hookah smoking; Social and family facilitators; Psychosocial needs and gaps and Sensory characteristic of hookah. Conclusion From this study, a variety of factors which contribute to the initiation of hookah smoking among women have been identified. Since one of the major causes of increased hookah smoking may be its ordinary use, all factors causing the ordinary use should be eliminated, and efforts should be made in opposition to hookah smoking promotions. PMID:26060781

  11. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia. Methods/Design A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio. The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support. We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching. Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period. Risk ratios will be used as the measure of effect of the intervention on the outcomes, and these will be estimated with 95% confidence intervals. All analyses will be based on the ‘intention to treat’ principle. Discussion This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy. Findings could be generalisable to similar populations in different settings. Trial registration ClinicalTrials.gov Identifier: NCT01823861 PMID:24330763

  12. Group Processes and EFL Learners' Motivation: A Study of Group Dynamics in EFL Classrooms

    ERIC Educational Resources Information Center

    Chang, Lilian Ya-Hui

    2010-01-01

    This study explores how group processes, such as group cohesiveness and group norms, influence an individual EFL learner's motivation. The uniqueness of this research lies in shifting the focus from an analysis of the individual's experience being seen as apart from the group to considering the individual's experience in relation to the social…

  13. An Exploratory Study of Expert Group Leadership

    ERIC Educational Resources Information Center

    Rubel, Deborah J.; Kline, William B.

    2008-01-01

    This article presents the results of a grounded theory exploration that described expert group leaders' experiences and perceptions during the process of leading groups in terms of influence of experience, preexisting knowledge and attitudes, and in-the-moment leadership process. The discussion presents implications for practice, counselor…

  14. Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial

    PubMed Central

    2013-01-01

    Background One in ten people aged between 55 to 74 years have a significant hearing impairment in their better hearing ear (as defined by audiometric hearing thresholds). However, it is becoming increasingly clear that the challenges faced by older listeners cannot be explained by the audiogram alone. The ability for people with hearing loss to use cognition to support speech perception allows for compensation of the degraded auditory input. This in turn offers promise for new cognitive-based rehabilitative interventions. Working memory is known to be highly associated with language comprehension and recent evidence has shown significant generalization of learning from trained working memory tasks to improvements in sentence-repetition skills of children with severe to profound hearing loss. This evidence offers support for further investigation into the potential benefits of working memory training to improve speech perception abilities in other hearing impaired populations. Methods/Design This is a double-blind randomized active controlled trial aiming to assess whether a program of working memory training results in improvements in untrained measures of cognition, speech perception and self-reported hearing abilities in adult hearing aid users (aged 50 to 74 years) with mild-to-moderate hearing loss, compared with an active control group who receive a placebo version of the working memory training program. Discussion The present study aims to generate high-quality preliminary evidence for the efficacy of working memory training for adults with mild-to-moderate sensorineural hearing loss who are existing hearing aid users. This trial addresses a number of gaps in the published literature assessing training interventions for people with hearing loss, and in the general literature surrounding working memory training, such as the inclusion of an active control group, participant and tester blinding, and increased transparency in reporting. Trial registration ClinicalTrials.gov identifier: NCT01892007. Date of registration: 27 June 2013. PMID:24304745

  15. Internet-based cognitive behavioural therapy for adults with tinnitus in the UK: study protocol for a randomised controlled trial

    PubMed Central

    Beukes, Eldré W; Manchaiah, Vinaya; Allen, Peter M; Baguley, David M; Andersson, Gerhard

    2015-01-01

    Introduction Tinnitus is one of the most distressing hearing-related symptoms. Innovative ways of managing tinnitus distress and the related healthcare burden of treating tinnitus are required. An internet-based cognitive behavioural therapy (iCBT) intervention has been developed in Sweden to improve access to evidence-based tinnitus treatments. This study aims to determine the feasibility and effectiveness of iCBT in reducing the impact associated with tinnitus, in the UK. It, furthermore, aims to establish whether there are subgroups of tinnitus sufferers for whom this iCBT intervention may be more suitable. Methods and analysis A two-armed randomised control trial—with a 1-year follow-up design—will be used to evaluate the effectiveness of iCBT on tinnitus distress. A delayed treatment design using a weekly check-in control group will be used. 70 participants will be randomly assigned to each group by an independent researcher by using a computer-generated randomisation schedule, and after being prestratified for age and tinnitus severity. They will undergo the iCBT e-health intervention online together with audiological therapeutic support. The main outcome measure is the Tinnitus Functional Index. Process evaluation of the intervention will also be conducted. Data analysis will be in accordance with Consolidated Standards of Reporting Trials guidelines. Ethics and dissemination Ethical approval has been granted. If this intervention proves effective, it may be possible that at least some tinnitus sufferers can be managed though an iCBT e-learning treatment programme. This would be cost effective and potentially will free up services for those with more severe problems that need face-to-face treatment. Trial registration number ClinicalTrials.gov; NCT02370810, date 05/03/2015. PMID:26399571

  16. Spinal cord stimulation for the treatment of refractory angina pectoris: a multicenter randomized single-blind study (the SCS-ITA trial).

    PubMed

    Lanza, Gaetano A; Grimaldi, Roberto; Greco, Salvatore; Ghio, Stefano; Sarullo, Filippo; Zuin, Guerrino; De Luca, Anna; Allegri, Massimo; Di Pede, Francesco; Castagno, Davide; Turco, Annalisa; Sapio, Monica; Pinato, Giampaolo; Cioni, Beatrice; Trevi, Giampaolo; Crea, Filippo

    2011-01-01

    Spinal cord stimulation (SCS) is believed to be effective in treating refractory angina. The need for SCS-related chest paresthesia, however, has hitherto made impossible placebo-controlled trials. Subliminal (non paresthesic) SCS, however, might be also effective on anginal pain. In this trial we compared subliminal SCS with paresthesic SCS and with sham SCS. Twenty-five refractory angina patients, who had never received SCS before, underwent SCS device implantation and were randomized to three groups: paresthesic SCS (group PS; n=10), subliminal SCS (group SS; n=7) or "sham" SCS (group NS; n=8). After 1month group NS patients were randomized to either group PS or SS. After 1month, changes in angina episodes (p=0.016), nitroglycerin use (p=0.015), angina class (p=0.02), quality of life score (p=0.05), and items 2 (p=0.008) and 3 (p=0.009) of Seattle angina questionnaire differed significantly among groups. Group PS showed significant improvement in outcomes compared to group NS, whereas there were no significant differences between groups SS and NS; furthermore, only nitroglycerin use differed significantly between groups PS and SS. At 3months, a significant difference between groups PS and SS was observed in angina attacks (p=0.002), but not in other variables. Thus, in this study, paresthesic, but not subliminal SCS was superior to sham SCS in improving clinical status in refractory angina patients. The lack of significant differences between PS and SS groups in this small study suggests that a possible role for subliminal SCS in individual patients deserves to be assessed in larger trials with appropriate statistical power. PMID:21084162

  17. Comparative Trial to Study the Effectiveness of Clonidine Hydrochloride and Buprenorphine-Naloxone in Opioid Withdrawal – A Hospital Based Study

    PubMed Central

    Farhat, Samina; Rather, Yasir Hassan; Abbas, Zaffar

    2015-01-01

    Objectives: Prevalence of opioid addiction has alarmingly increased over the recent years. In South Asian region alone there are more than 10 million opioid abusers amounting to 2% of world population. Detoxification remains to be the first step for the successful treatment of opioid addiction. The present study was carried out to compare the relative efficacy and safety of buprenorphine –naloxone and clonidine hydrochloride in the detoxification of opioid-dependents. Materials and Methods: Present trial was conducted at De- addiction centre of Institute of Mental and Neurosciences (IMNS), GMC Srinagar. Fifty four (54) treatment seeking subjects, 15-50 years of age, fulfilling DSM-1V TR (American Psychiatric association`s Mental Disorders-1V text revision) criteria for opioid dependence were included and randomized into two groups. The groups received either clonidine hydrochloride (Group A) or buprenorphine- naloxone (Bup-Nax) (Group B) for the duration of 10 days. The efficacy of the two drugs in controlling the opioid withdrawal was evaluated by Clinical Opioid Withdrawal Scale (COWS) and their effect on the desire for the abused substance was measured by Visual Analogue Scale (VAS). The safety of the two drugs was measured by taking the side effect profile of the two compared drugs into consideration. Results: There was significant difference of COWS-score between the two groups which was evident from day 3 (14.85 ± 3.43 vs. 11.67 ± 2.40, p<0.005) and continued till day 6 (2.56 ± 1.40 vs. 0.30 ± 0.61, p<0.005), for Group A and group B respectively. The effect of two drugs in controlling the craving for the abused substance also showed significant difference from day 2 (66.30 ± 10.80 vs. 47.40 ± 12.90, p<0.005) till day 5 (7.78 ± 6.41 vs. 1.85 ± 6.22, p<0.005), for Group A and Group B respectively. Conclusion: Administration of buprenorphine-naloxone was more efficient in reducing the signs and symptoms of opioid withdrawal and in controlling the craving for the abused substance during the first few days of detoxification. PMID:25738001

  18. 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 The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD. Trial Registration Current Controlled Trials ISRCTN88136485. PMID:24670079

  19. Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

    PubMed Central

    2013-01-01

    Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

  20. Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. Methods/Design The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention. Trial registration Australia and New Zealand Clinical Trials Registry Title: engaging youth with high prevalence mental health problems using family based interventions; number 12612000398808. Prospectively registered on 10 April 2012. PMID:24220547

  1. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial

    PubMed Central

    2013-01-01

    Background Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. Methods/designs This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. Discussion This pilot multicentre randomised controlled trial will explore the feasibility of further auricular acupuncture research and provide important clinical evidence for the effect and safety of auricular acupuncture on blood pressure in patients with prehypertension and stage 1 hypertension compared with usual care. Trial registration Clinical Research Information Service: KCT0000169 PMID:24053577

  2. PROSPECTIV—a pilot trial of a nurse-led psychoeducational intervention delivered in primary care to prostate cancer survivors: study protocol for a randomised controlled trial

    PubMed Central

    Watson, Eila; Rose, Peter; Frith, Emma; Hamdy, Freddie; Neal, David; Kastner, Christof; Russell, Simon; Walter, Fiona M; Faithfull, Sara; Wolstenholme, Jane; Perera, Rafael; Weller, David; Campbell, Christine; Wilkinson, Clare; Neal, Richard; Sooriakumaran, Prasanna; Butcher, Hugh; Matthews, Mike

    2014-01-01

    Background Prostate cancer survivors can experience physical, sexual, psychological and emotional problems, and there is evidence that current follow-up practices fail to meet these men's needs. Studies show that secondary and primary care physicians see a greater role for primary care in delivering follow-up, and that primary care-led follow-up is acceptable to men with prostate cancer. Methods and analysis A two-phase study with target population being men who are 9–24?months from diagnosis. Phase 1 questionnaire aims to recruit 300 men and measure prostate-related quality of life and unmet needs. Men experiencing problems with urinary, bowel, sexual or hormonal function will be eligible for phase 2, a pilot trial of a primary care nurse-led psychoeducational intervention. Consenting eligible participants will be randomised either to intervention plus usual care, or usual care alone (40 men in each arm). The intervention, based on a self-management approach, underpinned by Bandura's Social Cognitive Theory, will provide advice and support tailored to these men's needs and address any problems they are experiencing. Telephone follow-up will take place at 6?months. Study outcomes will be measured by a questionnaire at 7?months. Phase 1 will allow us to estimate the prevalence of urinary, sexual, bowel and hormone-related problems in prostate cancer survivors and the level of unmet needs. ‘Usual care’ will also be documented. Phase 2 will provide information on recruitment and retention, acceptability of the intervention/outcome measures, effect sizes of the intervention and cost-effectiveness data, which is required to inform development of a larger, phase 3 randomised controlled trial. The main outcome of interest is change in prostate-cancer-related quality of life. Methodological issues will also be addressed. Ethics and dissemination Ethics approval has been gained (Oxford REC A 12/SC/0500). Findings will be disseminated in peer-reviewed journals, at conferences, through user networks and relevant clinical groups. Trial registration number ISRCTN 97242511. PMID:24852301

  3. The childhood asthma prevention study (CAPS): design and research protocol of a randomized trial for the primary prevention of asthma.

    PubMed

    Mihrshahi, S; Peat, J K; Webb, K; Tovey, E R; Marks, G B; Mellis, C M; Leeder, S R

    2001-06-01

    The Childhood Asthma Prevention Study is a randomized controlled trial to measure whether the incidence of atopy and asthma can be reduced by house dust mite allergen reduction, a diet supplemented with omega-3 fatty acids, or a combination of both interventions. Six hundred and sixteen pregnant women whose unborn children were at high risk of developing asthma because of a family history were randomized prenatally. Study groups are as follows: Group A (placebo diet intervention, no house dust mite reduction), Group B (placebo diet intervention, active house dust mite reduction), Group C (active diet intervention, no house dust mite reduction), and Group D (active diet intervention, active house dust mite reduction). The house dust mite reduction intervention comprises use of physical and chemical methods to reduce allergen contact. The dietary intervention comprises use of a daily oil supplement from 6 months or at onset of bottle-feeding, and use of margarine and cooking oils based on sunflower or canola oils to increase omega-3 dietary intake. Data is collected quarterly until the infant is 1 year old and then half yearly until age 5 years. Questionnaires are used to collect respiratory illness history and information about diet and home environment. Dust is collected from the child's bed and bedroom and playroom floors. Blinded assessments are conducted at 18 months, 3 years, and 5 years. Skin prick tests to common allergens, blood tests, and detailed illness, medication use, and vaccination histories are collected. Primary outcomes will be the development of allergic sensitization and the presence and severity of asthma. This study is designed to measure the effectiveness of allergen reduction and dietary supplementation, both separately and in combination, for the primary prevention of atopy and asthma. The results of this study may have important implications for public health policies to reduce the incidence of childhood asthma. Control Clin Trials 2001;22:333-354 PMID:11384793

  4. Dialogical Approach Applied in Group Counselling: Case Study

    ERIC Educational Resources Information Center

    Koivuluhta, Merja; Puhakka, Helena

    2013-01-01

    This study utilizes structured group counselling and a dialogical approach to develop a group counselling intervention for students beginning a computer science education. The study assesses the outcomes of group counselling from the standpoint of the development of the students' self-observation. The research indicates that group counselling…

  5. Australasian Gastrointestinal Trials Group (AGITG) Contouring Atlas and Planning Guidelines for Intensity-Modulated Radiotherapy in Anal Cancer

    SciTech Connect

    Ng, Michael; Leong, Trevor; University of Melbourne ; Chander, Sarat; Chu, Julie; Kneebone, Andrew; University of Sydney ; Carroll, Susan; University of Sydney ; Wiltshire, Kirsty; Ngan, Samuel; University of Melbourne ; Kachnic, Lisa

    2012-08-01

    Purpose: To develop a high-resolution target volume atlas with intensity-modulated radiotherapy (IMRT) planning guidelines for the conformal treatment of anal cancer. Methods and Materials: A draft contouring atlas and planning guidelines for anal cancer IMRT were prepared at the Australasian Gastrointestinal Trials Group (AGITG) annual meeting in September 2010. An expert panel of radiation oncologists contoured an anal cancer case to generate discussion on recommendations regarding target definition for gross disease, elective nodal volumes, and organs at risk (OARs). Clinical target volume (CTV) and planning target volume (PTV) margins, dose fractionation, and other IMRT-specific issues were also addressed. A steering committee produced the final consensus guidelines. Results: Detailed contouring and planning guidelines and a high-resolution atlas are provided. Gross tumor and elective target volumes are described and pictorially depicted. All elective regions should be routinely contoured for all disease stages, with the possible exception of the inguinal and high pelvic nodes for select, early-stage T1N0. A 20-mm CTV margin for the primary, 10- to 20-mm CTV margin for involved nodes and a 7-mm CTV margin for the elective pelvic nodal groups are recommended, while respecting anatomical boundaries. A 5- to 10-mm PTV margin is suggested. When using a simultaneous integrated boost technique, a dose of 54 Gy in 30 fractions to gross disease and 45 Gy to elective nodes with chemotherapy is appropriate. Guidelines are provided for OAR delineation. Conclusion: These consensus planning guidelines and high-resolution atlas complement the existing Radiation Therapy Oncology Group (RTOG) elective nodal ano-rectal atlas and provide additional anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of IMRT for anal cancer.

  6. Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the ‘conscious target’: patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. Methods/Design A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. Discussion This ‘educational research’ project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake. Trial registration number Clinicaltrials.gov #NCT01360346 PMID:23551983

  7. The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial

    PubMed Central

    Vickers, Madge R; Martin, Jeannett; Meade, Tom W

    2007-01-01

    Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384), Australia (94), and New Zealand (24). In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results The trial was prematurely closed during recruitment following publication of early results from the Women's Health Initiative. At the time of closure, 56583 had been screened, 8980 entered run-in, and 5694 (26% of target of 22,300) randomised. Those women randomised had received a mean of one year of therapy, mean age was 62.8 years and total follow-up time was 6491 person years. Discussion The WISDOM experience leads to some simple messages. The larger a trial is the more simple it needs to be to ensure cost effective and timely delivery. When a trial is very costly and beyond the resources of one country, funders and investigators should make every effort to develop international collaboration with joint funding. PMID:17324282

  8. Biomarkers of sarcopenia in clincal trials recommendations from the international working group on sarcopenia

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the r...

  9. A Pilot Evaluation of Small Group Challenging Horizons Program (CHP): A Randomized Trial

    ERIC Educational Resources Information Center

    Langberg, Joshua M.; Smith, Bradley H.; Bogle, Kristin E.; Schmidt, Jonathan D.; Cole, Wesley R.; Pender, Carolyn A. S.

    2007-01-01

    This study examined the efficacy of an after-school program, the Challenging Horizons Program (CHP), that met four days a week and focused on improving organization, academic skills, and classroom behavior. The CHP was compared with a community control that included involvement in a district-run after-school program that met one to three days a…

  10. Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial

    PubMed Central

    2013-01-01

    Background Insulin resistance and hyperinsulinemia play a key role in the pathogenesis of polycystic ovary syndrome (PCOS), which is characterized by hyperandrogenism, ovulatory dysfunction, and presence of polycystic ovaries on pelvic scanning. Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Berberine has effects on insulin resistance but its use in women with PCOS has not been fully investigated. In this paper, we present a research design evaluating the effects of berberine on insulin resistance in women with PCOS. Methods/design This is a multicenter, randomized, placebo-controlled and double-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. Berberine or placebo will be taken orally for 12 weeks. The primary outcome is the whole body insulin action assessed with the hyperinsulinemic-euglycemic clamp. Discussion We postulate that women with PCOS will have improved insulin resistance following berberine administration. Trial registration This study is registered at ClinicalTrials.gov, NCT01138930. PMID:23866924

  11. Pathogen group-specific risk factors for intramammary infection in treated and untreated dairy heifers participating in a prepartum antimicrobial treatment trial.

    PubMed

    Passchyn, P; Piepers, S; De Vliegher, S

    2014-10-01

    Heifer mastitis is a well-known problem, with several pathogens being involved. Several generic risk factors associated with the likelihood of intramammary infections (IMI) in fresh dairy heifers have been identified before. Yet, a need exists to identify pathogen group-specific factors, as the effect of (groups of) pathogens on udder health and milk yield is different. The aim of the present study was to identify pathogen group-specific risk factors for IMI in heifers participating in a prepartum antimicrobial treatment trial, allowing us to test the hypothesis that different factors are of importance between treated and untreated control heifers as well. Data from a clinical trial in which end-term heifers were treated systemically (over 3 consecutive days) 2 wk before calving with penethamate hydriodide (n=76) or remained untreated (n=73), were available. Several potential risk factors at the herd, heifer, and quarter level were recorded in the first 3 d in milk. Quarters from untreated heifers supplemented with ?4 mg of selenium/d prepartum were significantly less likely to be infected with coagulase-negative staphylococci (CNS), whereas quarters were more likely to be infected with CNS when assistance during calving was needed. Udder edema before calving significantly decreased the odds of IMI with major pathogens. In treated heifers, no factors were detected that were associated with the likelihood of CNS IMI, whereas quarters from heifers were significantly more likely to be infected with major pathogens when they were housed in the calving pen more than 1 d and when they had been in contact with the lactating cows before calving. The risk factors for IMI that were identified in treated heifers were different than those in untreated heifers, independent of the pathogen group that was considered. It looks as if prepartum treatment not only changed the likelihood of infection, but also the factors that were associated with infection. However, except for treated heifers with an IMI with major pathogens, only a small proportion of the variation could be explained in the final models. Therefore, factors other than those that were studied could explain the likelihood of infection. PMID:25108863

  12. What is the ideal study design for evaluation of treatment for heart failure? Insights from trials assessing the effect of ACE inhibitors on exercise capacity.

    PubMed

    Narang, R; Swedberg, K; Cleland, J G

    1996-01-01

    There is a wealth of evidence that angiotensin converting enzyme (ACE) inhibitors improve symptoms, morbidity and mortality in patients with heart failure. In this context the use of ACE inhibitors could be considered a tool with which to assess the effect of trial design and methodology on the ability to detect improvement in symptoms and exercise performance. Thirty-five published, double-blind, randomized placebo-controlled trials, involving a total of 3411 patients, which compared the effect of ACE inhibitors and placebo on exercise capacity in patients with symptomatic chronic heart failure were identified. Studies were examined in relation to whether they used cross-over or parallel group study design, study size, use of treadmill vs bicycle exercise test, year of publication, patient entry criteria, duration of follow-up and the particular ACE inhibitor used. Exercise duration improved in 23 of the studies, while symptoms improved in 25 of the 33 studies which evaluated this. In the majority of the trials (27 of 33) there was concordance between the effect on symptoms and on exercise capacity. There were six trials which showed discrepant results. Study size, duration of follow-up and method of exercise testing used were found to be major factors affecting the outcome. Trials using treadmill exercise tests were more likely to be positive than those using bicycle ergometry. All nine trials with study size more than 50, follow-up of 3-6 months and using treadmill exercise tests showed improved exercise capacity as well as symptoms. These findings may be useful in designing future trials for evaluating treatment for heart failure. PMID:8682118

  13. CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption – study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cannabis is the most consumed illegal substance in France. General practitioners (GPs) are the health professionals who are most consulted by adolescents. Brief intervention (BI) is a promising care initiative for the consumption of cannabis, and could be a tool for GPs in caring for adolescents who consume cannabis. The aim of the CANABIC study is to measure the impact of a BI carried out by a GP on the consumption of cannabis by adolescents of 15 to 25 years of age. Methods A randomized clustered controlled trial, stratified over three areas (Auvergne, Languedoc-Roussillon, and Rhône - Alpes), comparing an intervention group, which carries out the BI in consultation, and a control group, which ensures routine medical care. The main assessment criterion is the consumption of cannabis by amount of joints per month, at 12 months. The amount necessary to highlight a significant difference between the two groups of 30% of consumption at 12 months is 250 patients (50 GPs, 5 patients per GP; risk ??=?5%; power?=?90%; intra-cluster correlation coefficient ??=?0.2; Hawthorne effect?=?15%; lost to follow-up rates for GPs?=?10% and for patients?=?20%). This plan is replicated for the three areas, and therefore a total of 750 patients are expected. The secondary criteria for judgment are the associated consumption of tobacco and alcohol, the perception of the consequences of consumption, and the driving of a vehicle following consumption. Discussion Research about BI for young cannabis users is underway. The aim of the CANABIC study is to validate a BI suited to adolescents who consume cannabis, which may be performed in the general practice. This would provide a tool for their treatment by a GP, which could be widely distributed during initial or further medical training. Trial registration CANABIC is a randomized clustered trial (NCT01433692, registered 2011 Sept 12), PHRC funded: Clinical Research Hospital Program (Governmental Fund, Health Ministry). Date first patient randomized: March 2012. PMID:24479702

  14. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    PubMed Central

    2011-01-01

    Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM) in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs) in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526 PMID:21303564

  15. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE): study protocol of a cluster randomized controlled trial

    PubMed Central

    2010-01-01

    Background People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany) as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group). The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360) as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration ClinicalTrials.gov NCT00653731 PMID:20113526

  16. Discontinuing Inappropriate Medication in Nursing Home Residents (DIM-NHR Study): protocol of a cluster randomised controlled trial

    PubMed Central

    Wouters, Hans; Quik, Elise H; Boersma, Froukje; Nygård, Peder; Bosman, Judith; Böttger, Wendelien M; Mulder, Hans; Maring, Jan-Gerard; Wijma-Vos, Linda; Beerden, Tim; van Doormaal, Jasperien; Postma, Maarten J; Zuidema, Sytse U; Taxis, Katja

    2014-01-01

    Introduction Nursing home residents often have a high number of comorbidities resulting in polypharmacy. Inappropriate prescribing is therefore likely to occur, which in turn is expected to worsen cognitive impairment, to increase the fall risk and to decrease residents’ quality of life. The objective of the ‘Discontinuing Inappropriate Medication in Nursing Home Residents’ (DIM-NHR) study is to examine the efficacy and cost-effectiveness of the Multidisciplinary Multistep Medication Review (3MR) that is aimed at optimising prescribing and discontinuing inappropriate medication. Methods A cluster randomised controlled trial will be conducted. Elderly care physicians and their wards (clusters) will be randomised. Data will be collected at baseline and 4?months after the 3MR has taken place. Six hundred nursing home residents will be recruited of whom more than half are expected to suffer from dementia. The 3MR will be based on consensus criteria and the relevant literature and will be performed by the patient’s elderly care physician in collaboration with a pharmacist. Analysis Primary outcomes—the difference in proportion of residents who successfully discontinued inappropriate medication between the intervention and control group at follow-up. Secondary outcomes—undertreatment, exposure to anticholinergic and sedative medicines, neuropsychiatric symptoms, cognitive function, falls, hospital admission, quality of life and cost-effectiveness. Ethics and dissemination Participant burden will be kept at a minimum. The elderly care physician will remain free to adjust medication when symptoms relapse or adverse events occur, rendering serious adverse events highly unlikely. Study findings will be published in peer-reviewed journals and a 3MR toolkit will be developed. Trial registration number This study has been registered at http://www.ClinicalTrials.gov (trial registration number: NCT01876095) PMID:25296655

  17. Phase I trial of erlotinib with radiation therapy in patients with glioblastoma multiforme: Results of North Central Cancer Treatment Group protocol N0177

    SciTech Connect

    Krishnan, Sunil . E-mail: skrishnan@mdanderson.org; Brown, Paul D.; Ballman, Karla V.; Fiveash, John B.; Uhm, Joon H.; Giannini, Caterina; Jaeckle, Kurt A.; Geoffroy, Francois J.; Nabors, L. Burt; Buckner, Jan C.

    2006-07-15

    Purpose: To evaluate the toxicity and maximum tolerated dose (MTD) of erlotinib plus radiation therapy (RT) in patients with glioblastoma multiforme (GBM) in a multicenter phase I trial. Methods and Materials: Patients were stratified on the basis of the use of enzyme-inducing anticonvulsants (EIACs). After resection or biopsy, patients were treated with erlotinib for 1 week before concurrent erlotinib and 6 weeks (60 Gy) of RT and maintained on erlotinib until progression. The erlotinib dose was escalated in cohorts of 3 starting at 100 mg/day. Results: Twenty patients were enrolled and 19 were evaluable for the MTD and efficacy endpoints. Of these patients, 14 were males and 5 were females, with a median age of 54 years. Seven had undergone biopsy only, 5 had subtotal resections, and 7 had gross total resections. The highest dose level was 150 mg/day erlotinib for patients not on EIACs (Group 1) and 200 mg/day for patients on EIACs (Group 2). MTD was not reached in either group. In Group 1 at 100 mg (n = 6) and at 150 mg (n = 4), only 1 dose-limiting toxicity (DLT) occurred (stomatitis at 100 mg). No DLTs have occurred in Group 2 at 100 mg (n = 3), 150 mg (n = 3), and 200 mg (n = 3). With a median follow-up of 52 weeks, progression was documented in 16 patients and 13 deaths occurred. Median time to progression was 26 weeks, and median survival was 55 weeks. Conclusion: Toxicity is acceptable at the current doses of erlotinib plus RT. The study was modified to include concurrent and adjuvant temozolomide, and accrual is in progress.

  18. Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cerebral palsy (CP) is the most common motor disability in childhood (2 to 3 per 1000 live births), and is frequently accompanied by cognitive impairments and behavioural problems. Children with CP are at increased risk of attention deficit disorder with or without hyperactivity (Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD)) including working memory deficits. The primary aim of this study is to evaluate if cognitive training may improve working memory in children with CP. Methods/Designs The study is an investigator-blinded, randomized controlled trial with a stepped-wedge design that will include 115 schoolchildren with CP. Eligible for participation are children with CP, aged 7 to 15 years, who are able to follow instructions and handle a computer mouse. Exclusion criteria are the presence of photosensitive epilepsy, Gross Motor Function Classification System (GMFCS) level V (most severe CP) (Phys Ther 80: 974-985, 2000) and severe visual or hearing impairments. Following assessment of eligibility and baseline cognitive assessment the participants will be randomized to either cognitive working memory training or treatment-as-usual (‘control group’). The intervention is a computer-based working memory training program consisting of 25 daily sessions to be performed over a 5 to 6-week period at home. A neuropsychological assessment will be performed before and 4 to 6 weeks after completed training. When the latter assessment has been completed in the intervention group, the ‘control group’ will start on the same training program. Both groups will meet for a final neuropsychological assessment six months after completed training by an examiner unaware of group adherence. Discussion There is limited evidence for the effect of most interventions in children with CP, and evidence is completely lacking for interventions aiming to improve deficits in cognition, learning and behaviour. The proposed multicenter study, will bring forth comprehensive information about cognitive, neuropsychological, and daily-life functioning in children with CP aged between 7 and 15 years. In addition, the study will be the first to evaluate the effects of an intervention method to improve working memory in children with CP. If successful, computer-based working memory training may represent an efficient and cost-effective intervention for this group of children. Trial registration ClinicalTrials.gov Identifier: NCT02119364 PMID:24998242

  19. No evidence of a control group response in exercise randomised controlled trials in people with schizophrenia: A systematic review and meta-analysis.

    PubMed

    Stubbs, Brendon; Rosenbaum, Simon; Ward, Philip B; Barreto Schuch, Felipe; Vancampfort, Davy

    2015-10-30

    Increased control group responses (CGR) make it more difficult to establish the effectiveness of interventions to improve symptoms in schizophrenia. We conducted a meta-analysis of CGR within randomised control trials (RCTs) comparing exercise and a control condition in people with schizophrenia. We found no evidence of a CGR for total, positive or negative symptoms. Control group responses do not negatively impact exercise RCTs that have clearly demonstrated substantial beneficial effects of exercise in this population. PMID:26254799

  20. Involving users in the design of a randomised controlled trial of an intervention to promote early presentation in breast cancer: qualitative study. | accrualnet.cancer.gov

    Cancer.gov

    Researchers gleaned insights into the preferred ways to approach study participants for recruitment and follow-up, the acceptability of an “opt-out” consent that assumes patients will participate in the study unless they opt-out, and support for using routine data sets to identify study participants. Collecting feedback on the design of clinical trials from users through interviews and focus groups may lead to improvements in protocols.

  1. The PROblem Gambling RESearch Study (PROGRESS) research protocol: a pragmatic randomised controlled trial of psychological interventions for problem gambling

    PubMed Central

    Thomas, Shane A; Merkouris, Stephanie S; Browning, Colette J; Radermacher, Harriet; Feldman, Susan; Enticott, Joanne; Jackson, Alun C

    2015-01-01

    Introduction International prevalence rates for problem gambling are estimated at 2.3%. Problem gambling is a serious global public health concern due to adverse personal and social consequences. Previous research evaluating the effectiveness of psychological interventions for the treatment of problem gambling has been compromised by methodological limitations, including small sample sizes and the use of waitlist control groups. This article describes the study protocol for a pragmatic randomised controlled trial (RCT) evaluating the effectiveness of cognitive-behavioural therapy (CBT), behaviour therapy (BT), motivational interviewing (MI) against a non-directive supportive therapy (NDST) control, in treating problem gambling. Methods and analysis This study was a mixed-methods design, with a parallel group, pragmatic RCT as the primary component, and embedded qualitative studies conducted alongside. A total of 297 participants were recruited from the community in Victoria, Australia. Individuals aged 18?years and over, could communicate in English and wished to receive treatment for a gambling problem were eligible. Participants were randomly allocated in to 1 of the 4 psychological interventions: CBT, BT, MI and NDST. Repeated measures were conducted at pretreatment and post-treatment, and 6 and 12?months post-treatment. The statistical analysis will use an intention-to-treat approach. Multilevel mixed modelling will be used to examine changes in the primary outcome measures: gambling symptom severity, using the Gambling Symptom Assessment Scale, and gambling behaviours (frequency, time and expenditure). Secondary outcomes are depression, anxiety, stress and alcohol use. Individual semistructured qualitative interviews were conducted at pretreatment and post-treatment and 12?months post-treatment for a subset of participants (n=66). Ethics and dissemination This study was approved by the Victorian Department of Justice, Monash University and the University of Melbourne Human Research Ethics Committees. Findings will be reported in a government report, peer-reviewed publications and conference presentations. Trial registration number Current Controlled Trials ISRCTN01629698. PMID:26603250

  2. A Randomised Controlled Trial of Intravenous Zoledronic Acid in Malignant Pleural Disease: A Proof of Principle Pilot Study

    PubMed Central

    Clive, Amelia O.; Hooper, Clare E.; Edey, Anthony J.; Morley, Anna J.; Zahan-Evans, Natalie; Hall, David; Lyburn, Iain; White, Paul; Braybrooke, Jeremy P.; Sequeiros, Iara; Lyen, Stephen M.; Milton, Tim; Kahan, Brennan C.; Maskell, Nick A.

    2015-01-01

    Introduction Animal studies have shown Zoledronic Acid (ZA) may diminish pleural fluid accumulation and tumour bulk in malignant pleural disease (MPD). We performed a pilot study to evaluate its effects in humans. Methods We undertook a single centre, double-blind, placebo-controlled trial in adults with MPD. Patients were randomised (1:1) to receive 2 doses of intravenous ZA or placebo, 3 weeks apart and were followed-up for 6 weeks. The co-primary outcomes were change in Visual Analogue Scale (VAS) score measured breathlessness during trial follow-up and change in the initial area under the curve (iAUC) on thoracic Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) from randomisation to week 5. Multiple secondary endpoints were also evaluated. Results Between January 2010 and May 2013, 30 patients were enrolled, 24 randomised and 4 withdrew after randomisation (1 withdrew consent; 3 had a clinical decline). At baseline, the ZA group were more breathless, had more advanced disease on radiology and worse quality of life than the placebo group. There was no significant difference between the groups with regards change in breathlessness (Adjusted mean difference (AMD) 4.16 (95%CI ?4.7 to 13.0)) or change in DCE-MRI iAUC (AMD ?15.4 (95%CI ?58.1 to 27.3). Two of nine (22%) in the ZA arm had a >10% improvement by modified RECIST (vs 0/11 who received placebo). There was no significant difference in quality of life measured by the QLQ-C30 score (global QOL: AMD -4.1 (-13.0 to 4.9)), side effects or serious adverse event rates. Conclusions This is the first human study to evaluate ZA in MPD. The study is limited by small numbers and imbalanced baseline characteristics. Although no convincing treatment effect was identified, potential benefits for specific subgroups of patients cannot be excluded. This study provides important information regarding the feasibility of future trials to evaluate the effects of ZA further. Trial Registration UK Clinical Research Network ID 8877 ISRCTN17030426 www.isrctn.com PMID:25781025

  3. Research: Educational and Psychological Issues Effectiveness of a group diabetes education programme in under-served communities in South Africa: a pragmatic cluster randomized controlled trial

    PubMed Central

    Mash, R J; Rhode, H; Zwarenstein, M; Rollnick, S; Lombard, C; Steyn, K; Levitt, N

    2014-01-01

    Aim To evaluate the effectiveness of group education, led by health promoters using a guiding style, for people with Type 2 diabetes in public sector community health centres in Cape Town. Methods This was a pragmatic clustered randomized controlled trial with 17 randomly selected intervention and 17 control sites. A total of 860 patients with Type 2 diabetes, regardless of therapy used, were recruited from the control sites and 710 were recruited from the intervention sites. The control sites offered usual care, while the intervention sites offered a total of four monthly sessions of group diabetes education led by a health promoter. Participants were measured at baseline and 12 months later. Primary outcomes were diabetes self-care activities, 5% weight loss and a 1% reduction in HbA1c levels. Secondary outcomes were self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c and mean total cholesterol levels and quality of life. Results A total of 422 (59.4%) participants in the intervention group did not attend any education sessions. No significant improvement was found in any of the primary or secondary outcomes, apart from a significant reduction in mean systolic (-4.65 mmHg, 95% CI 9.18 to -0.12; P = 0.04) and diastolic blood pressure (-3.30 mmHg, 95% CI -5.35 to -1.26; P = 0.002). Process evaluation suggested that there were problems with finding suitable space for group education in these under-resourced settings, with patient attendance and with full adoption of a guiding style by the health promoters. Conclusion The reported effectiveness of group diabetes education offered by more highly trained professionals, in well-resourced settings, was not replicated in the present study, although the reduction in participants’ mean blood pressure is likely to be of clinical significance. What’s new? The study adds to the scarce literature on diabetes education in Africa in the face of a growing public health problem in this continent. The study demonstrates a statistically and clinically significant reduction in participants’ mean blood pressure 1 year after the educational intervention. The study adds to the small amount of literature on group motivational interviewing type interventions for diabetes. The study adds to the small amount of literature on the use of lower-/mid-level health workers for diabetes education. PMID:24766179

  4. Confronting diversity in the production of clinical evidence goes beyond merely including under-represented groups in clinical trials

    PubMed Central

    2013-01-01

    There is increasing evidence that outcomes of health care differ by patient characteristics, such as gender and ethnicity. If evidence-based medicine is to improve quality of care for all patients, it is essential to take this diversity into account when designing clinical studies. So far, this notion has mainly been translated into recommendations for including minority populations in trials. We argue that a more comprehensive view of the production of diversity-sensitive clinical evidence is needed, one that takes heterogeneity as a starting point in research. We call for a mix of methodological approaches aimed at identifying diversity issues that matter and analysing the impact of these diversities on clinical outcomes. Institutional changes are necessary to support this methodological reform. PMID:23768231

  5. Effectiveness of preventive support groups for children of mentally ill or addicted parents: a randomized controlled trial.

    PubMed

    van Santvoort, Floor; Hosman, Clemens M H; van Doesum, Karin T M; Janssens, Jan M A M

    2014-06-01

    In various countries preventive support groups are offered to children of mentally ill and/or addicted parents to reduce the risk that they will develop problems themselves. This study assessed the effectiveness of Dutch support groups for children aged 8-12 years old in terms of reducing negative cognitions; improving social support, competence, and parent-child interaction (direct intervention goals); and reducing emotional and behavioural problems (ultimate intervention aim). Children from 254 families were randomly assigned to the intervention or a control condition. Parents and children completed questionnaires at baseline and 3 and 6 months later. Emotional and behavioural problems of intervention group children were also assessed 1 year after the start. Univariate analyses of variance showed that children in the intervention group experienced a greater decrease in negative cognitions and sought more social support, immediately after participation and 3 months later, as compared to control group children. They also remained stable in their feelings of social acceptance (competence aspect) immediately after the intervention, whereas these feelings declined in control group children. The intervention and control groups both improved over time in terms of cognitions, competence, parent-child interaction and emotional and behavioural problem scores. Additional improvement in terms of problem scores was found in the intervention group 1 year after baseline. Further enhancement of effectiveness requires re-consideration of the support group goals; it should be studied whether the goals reflect the most important and influential risk and protective factors for this specific population. Besides, effects should be studied over a longer period. PMID:24072523

  6. A Primer on Randomized Controlled Trials

    PubMed Central

    Likosky, Donald S.

    2006-01-01

    Abstract: Randomized Clinical Trials are held as the gold standard for quantifying the effect of an intervention across two or more groups. In such a trial an intervention is randomly allocated to one of two groups. The benefit of such a trial lies in its ability to establish nearly comparable groups of subjects in all manner except for the effect of the intervention. As such, the effect of a given intervention may be attributed solely to the intervention and not to any other extraneous factor. In the following editorial, we will discuss several issues that are important for understanding how to conduct and interpret randomized trials: choosing the study population, choosing the comparison group, choosing your outcome, study design, data analysis, and issues of inference. This editorial is intended to make the reader an educated consumer of such trial designs. PMID:16637517

  7. Comparative study of hemodynamic changes caused by diazepam and midazolam during third molar surgery: a randomized controlled trial.

    PubMed

    de Morais, Hécio Henrique Araújo; Barbalho, Jimmy Charles Melo; de Holanda Vasconcellos, Ricardo José; Landim, Fabricio Souza; da Costa Araújo, Fábio Andrey; de Souza Dias, Tasiana Guedes

    2015-09-01

    The aim of the present study was to compare hemodynamic changes using midazolam 7.5 mg and diazepam 10.0 mg during the surgical removal of symmetrically positioned third molars. A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided into three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo), and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia. The following parameters were assessed at five different times (T0, T1, T2, T3, and T4): systolic, diastolic, and mean blood pressure (SBP, DBP, and MBP, respectively); heart rate (HR); oxygen saturation (SpO(2)); rate pressure product (RPP); and pressure rate quotient (PRQ). Statistically significant differences were found regarding heart rate at T2 and T3 (p?Group 2, with a higher rate occurring during midazolam administration. Moreover, significant differences in rate pressure product were found at T2, T3, and T4 in this group, with higher values also occurring during midazolam administration. In Group 3, significant differences in diastolic blood pressure were found at T3 and T4, with higher values occurring during diazepam administration, whereas a higher heart rate occurred at T3 with midazolam. Midazolam 7.5 mg and diazepam 10.0 mg exert an influence on some hemodynamic parameters without perceptible clinical changes in healthy patients undergoing lower third molar surgery. PMID:25711726

  8. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

    PubMed Central

    2012-01-01

    Background A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. Methods/Design This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, “ReCaPTure LiFe” will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15–25 years who have completed cancer treatment in the past 1–6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. Discussion This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both peer and caregiver support in enhancing the effectiveness of this skills-based intervention is also discussed. The innovative videoconferencing delivery method Recapture Life uses has the potential to address the geographic and psychological isolation of adolescents and young adults as they move toward cancer survivorship. It is expected that teaching AYAs coping skills as they resume their normal lives after cancer may have long-term implications for their quality of life. Trial Registration ACTRN12610000717055 PMID:22862906

  9. Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial

    PubMed Central

    Cabezas, Carmen; Martin, Carlos; Granollers, Silvia; Morera, Concepció; Ballve, Josep Lluis; Zarza, Elvira; Blade, Jordi; Borras, Margarida; Serra, Antoni; Puente, Diana

    2009-01-01

    Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC). Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people). Intention to treat analysis. Study population: Smokers (n = 3024) aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ? 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The application of a stepped intervention based on the stages of a change model is possible under real and diverse clinical practice conditions, and improves the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline. Trial Registration Clinical Trials.gov Identifier: NCT00125905 PMID:19193233

  10. DISCOVER trial– Distal resection of the pancreas with or without coverage of the pancreatic remnant: study protocol of a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Distal pancreatectomy for benign and malignant tumours is the second most common surgical procedure on the pancreas. Postoperative pancreatic fistulas (POPF) represent the most significant clinical complication, causing prolongation of hospital stay and the need for additional diagnostic and therapeutic procedures. Although various techniques for preventing POPF have been evaluated, to date, there is no available technique that ensures closure of the pancreatic remnant. Methods/Design DISCOVER will aim to investigate differences in the postoperative course after a distal pancreatectomy comparing the standard surgical technique with an alternative technique that provides additional coverage of the pancreatic remnant by the falciform ligament. The primary endpoint of this trial will be the rate of POPF. As secondary endpoints, incidence of postoperative morbidity and mortality, length of hospital stay, and quality of life will be assessed. DISCOVER is a single-centre, randomised, controlled surgical trial. For statistical analysis, a binary logistic regression model will be used. With a level of significance of 5% and a power of 80%, a sample size of 75 patients per group has been identified as necessary. Discussion The findings of this trial will help to evaluate the usefulness of the coverage procedure at reducing the rate of POPF. The results could influence the standard procedure for remnant closure after distal pancreatectomy. Trial-registration Clinical trials register (DRKS-ID: DRKS00000546) PMID:24330450

  11. A comparative study between intrathecal dexmedetomidine and fentanyl as adjuvant to intrathecal bupivacaine in lower abdominal surgeries: A randomized trial

    PubMed Central

    Khan, Aamir Laique; Singh, Raj Bahadur; Tripathi, Rajni K.; Choubey, Sanjay

    2015-01-01

    Context: Spinal anesthesia is preferred choice of anesthesia in lower abdominal surgeries since long time. However problem with this is limited duration of action, so for long duration surgeries alternative are required. Dexmedetomidine is a highly selective alpha-2-adrenergic agonist has property to potentiate the action of local anesthetic used in spinal anesthesia. Fentanyl is an opioid and it has also the same property. Aims: To compare the efficacy, analgesic effects, and side-effects of dexmedetomidine and fentanyl as adjuvant to bupivacaine for lower abdominal surgery. Settings and Design: The type of this study was double-blind randomized trial. Subjects and Methods: A total of 80 patients were randomly allocated in two Group D and Group F. Group D were injected injection bupivacaine 0.5% heavy × 3.0 ml + 0.5 ml of preservative free normal saline containing 5 ?g dexmedetomidine. Group F were received injection bupivacaine 0.5% heavy × 3.0 ml + 0.5 ml fentanyl equivalent to 25 ?g. Statistical Analysis Used: The statistical analysis was performed using SPSS (Statistical Package for Social Sciences) version 15.0 statistical analysis software. Results: The results show that highest sensitivity level of T6 and T8 was achieved by higher proportion of subjects from Group D when compared to Group F and sensitivity level T7 was achieved by higher proportion of subjects of Group F when compared to Group D. Duration of analgesic properties was significantly higher in Group D when compared to Group F. Conclusion: The findings in the present study suggested that intrathecal adjuvant use of dexmedetomidine as compared to fentanyl provides a longer sensory and motor blockade and also prolongs the postoperative analgesic effect. PMID:26417118

  12. Participants' recommendations for the ideal grief group: a qualitative study.

    PubMed

    Dyregrov, Kari; Dyregrov, Atle; Johnsen, Iren

    2013-01-01

    Based on the results from the qualitative part of the study "Grief Groups in Norway" conducted in 2009-2011, this article focuses on grief group participants' recommendations for good or ideal grief groups. Participants have insightful observations about grief groups and how they can be improved, and taking their point of view seriously is one important way of ensuring that users of such group get an optimal experience from joining such groups. Using their experiences to adjust the structure and function of the groups, one can allow for practical solutions for organizations that have difficulties starting up grief support groups, for example, in areas where the population density is low. A major finding in this study was that grief group participants stressed the importance of thorough information before and at the start of grief groups. This concerned information about the aim, structure, organization, and possible effects and limitations of group participation. PMID:24416876

  13. Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials

    PubMed Central

    2014-01-01

    Background As the population ages, more people are suffering from long-term health conditions (LTCs). Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth: technologies such as the Internet, telephone and home self-monitoring. Methods/Design This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs. Two randomized controlled trials will be conducted in parallel, recruiting patients with two exemplar LTCs: depression or raised cardiovascular disease (CVD) risk. A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol, Sheffield and Southampton, UK. Participants will be randomly allocated to either usual care (control group) or usual care plus the NHS Direct Healthlines Service (intervention group). The intervention is based on a conceptual model incorporating promotion of self-management, optimisation of treatment, coordination of care and engagement of patients and general practitioners. Participants will be provided with tailored help, combining telephone advice from health information advisors with support to use a range of online resources. Participants will access the service for 12 months. Outcomes will be collected at baseline, four, eight and 12 months for the depression trial and baseline, six and 12 months for the CVD risk trial. The primary outcome will be the proportion of patients responding to treatment, defined in the depression trial as a PHQ-9 score <10 and an absolute reduction in PHQ-9 ?5 after 4 months, and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months. The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services. An embedded qualitative interview study will explore healthcare professionals’ and patients’ views of the intervention. Discussion This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation. The study will also analyse health economic information. In doing so, the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention. Trial registration Current Controlled Trials: Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731. PMID:24460845

  14. Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II/III multicentre, randomised, double-blind, placebo-controlled trial

    PubMed Central

    Katayama, Kanako; Misawa, Sonoko; Sato, Yasunori; Sobue, Gen; Yabe, Ichiro; Watanabe, Osamu; Nishizawa, Masatoyo; Kusunoki, Susumu; Kikuchi, Seiji; Nakashima, Ichiro; Ikeda, Shu-ichi; Kohara, Nobuo; Kanda, Takashi; Kira, Jun-ichi; Hanaoka, Hideki; Kuwabara, Satoshi

    2015-01-01

    Introduction Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease. Methods and analysis The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100–300?mg daily) plus dexamethasone (12?mg/m2 on days 1–4 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24?weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24?weeks. Ethics and dissemination The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants. Trial registration number UMIN000004179 and JMA-IIA00046. PMID:25573527

  15. Evaluation of ergonomic and education interventions to reduce occupational sitting in office-based university workers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Prolonged sitting is a specific occupational hazard in office workers. There is growing evidence that prolonged sitting is detrimental to metabolic health. The aim of this study is to determine whether providing office workers with education along with adjustable sit-stand workstations leads to reduction in sitting behavior. Methods/Design A randomized control trial (RCT) with three groups (one control group and two intervention groups) will be conducted in an office workplace setting. The education intervention group will receive an education package that encourages reduction in sitting behaviors. The sit-stand desk intervention group will receive the same education package along with an adjustable sit-stand desk. Participants will be included in the study if they are currently employed in a full-time academic or administrative role that involves greater than 15 hours per week or greater than 4 hours per day computer-based work. Baseline data will include participant’s age, gender, weight, height, smoking habit, employment position, level of education, and baseline self-reported leisure time physical activity. The primary outcome is the average daily sedentary time during work hours, measured by an accelerometer. Participant recruitment commenced in March 2013 and will be completed by December 2013. Discussion This study will determine whether providing office workers with an adjustable sit-stand desk and individually targeted education, or education alone, is more effective in decreasing sitting behaviors than no intervention. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12613000366752 PMID:24119552

  16. Trial Watch

    PubMed Central

    Vacchelli, Erika; Eggermont, Alexander; Fridman, Wolf Hervé; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-01-01

    During the past two decades, the notion that cancer would merely constitute a cell-intrinsic disease has gradually been complemented by a model postulating that the immune system plays a relevant role during all stages of oncogenesis and tumor progression. Along with this conceptual shift, several strategies have been devised to stimulate tumor-specific immune responses, including relatively unselective approaches such as the systemic administration of adjuvants or immunomodulatory cytokines. One year ago, in the July issue of OncoImmunology, we described the main biological features of this large group of proteins and discussed the progress of ongoing clinical studies evaluating their safety and therapeutic potential in cancer patients. Here, we summarize the latest developments in this area of clinical research, focusing on high impact studies that have been published during the last 13 mo and clinical trials launched in the same period to investigate which cytokines can be employed as safe and efficient immunostimulatory interventions against cancer. PMID:24073369

  17. Time to activate lung cancer clinical trials and patient enrollment: a representative comparison study between two academic centers across the Atlantic. | accrualnet.cancer.gov

    Cancer.gov

    This study compared time to activate lung clinical trials and patient enrollment at a U.S. site and at a European site. Lessons learned from this comparison may provide insight into ways to shorten the clinical trial activation process. Lengthy and laborious administrative procedures are the root of slow activation of oncology trials in the United States. Slow clinical trial activation is a barrier to accrual. Increasing globalization of clinical trials necessitates understanding of clinical trial processes in other countries.

  18. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    PubMed Central

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group. PMID:26300719

  19. Resveratrol and Clinical Trials: The Crossroad from In Vitro Studies to Human Evidence

    PubMed Central

    Tomé-Carneiro, Joao; Larrosa, Mar; González-Sarrías, Antonio; Tomás-Barberán, Francisco A.; García-Conesa, María Teresa; Espín, Juan Carlos

    2013-01-01

    Resveratrol (3,5,4’-trihydroxy-trans-stilbene) is a non-flavonoid polyphenol that may be present in a limited number of food-stuffs such as grapes and red wine. Resveratrol has been reported to exert a plethora of health benefits through many different mechanisms of action. This versatility and presence in the human diet have drawn the worldwide attention of many research groups over the past twenty years, which has resulted in a huge output of in vitro and animal (preclinical) studies. In line with this expectation, many resveratrol-based nutraceuticals are consumed all over the world with questionable clinical/scientific support. In fact, the confirmation of these benefits in humans through randomized clinical trials is still very limited. The vast majority of preclinical studies have been performed using assay conditions with a questionable extrapolation to humans, i.e. too high concentrations with potential safety concerns (adverse effects and drug interactions), short-term exposures, in vitro tests carried out with non-physiological metabolites and/or concentrations, etc. Unfortunately, all these hypothesis-generating studies have contributed to increased the number of ‘potential’ benefits and mechanisms of resveratrol but confirmation in humans is very limited. Therefore, there are many issues that should be addressed to avoid an apparent endless loop in resveratrol research. The so-called ‘Resveratrol Paradox’, i.e., low bioavailability but high bioactivity, is a conundrum not yet solved in which the final responsible actor (if any) for the exerted effects has not yet been unequivocally identified. It is becoming evident that resveratrol exerts cardioprotective benefits through the improvement of inflammatory markers, atherogenic profile, glucose metabolism and endothelial function. However, safety concerns remain unsolved regarding chronic consumption of high RES doses, specially in medicated people. This review will focus on the currently available evidence regarding resveratrol’s effects on humans obtained from randomized clinical trials. In addition, we will provide a critical outlook for further research on this molecule that is evolving from a minor dietary compound to a possible multi-target therapeutic drug. PMID:23448440

  20. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration

    PubMed Central

    Scott, Amelia; Rucklidge, Julia J.; Mulder, Roger T.

    2015-01-01

    Objective To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding. Materials and Methods Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type. Results Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding. Discussion Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration. PMID:26287998

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

    PubMed Central

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

    2014-01-01

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

  2. Parents’ Agendas in Paediatric Clinical Trial Recruitment Are Different from Researchers’ and Often Remain Unvoiced: A Qualitative Study

    PubMed Central

    Woolfall, Kerry; Shilling, Valerie; Hickey, Helen; Smyth, Rosalind L.; Sowden, Emma; Williamson, Paula R.; Young, Bridget

    2013-01-01

    Ensuring parents make an informed decision about their child’s participation in a clinical trial is a challenge for practitioners as a parent’s comprehension of a trial may differ from that intended by the practitioners responsible for recruitment. We explored what issues parents consider important when making a decision about participation in a paediatric clinical trial and their comprehension of these issues to inform future recruitment practice. This qualitative interview and observational study examined recruitment in four placebo-controlled, double-blind randomised clinical trials of medicines for children. Audio-recorded trial recruitment discussions between practitioners and parents (N?=?41) were matched with semi-structured interviews with parents (N?=?41). When making a decision about trial entry parents considered clinical benefit, child safety, practicalities of participation, research for the common good, access to medication and randomisation. Within these prioritised issues parents had specific misunderstandings, which had the potential to influence their decisions. While parents had many questions and concerns about trial participation which influenced their decision-making, they rarely voiced these during discussions about the trials with practitioners. Those involved in the recruitment of children to clinical trials need to be aware of parents’ priorities and the sorts of misunderstandings that can arise with parents. Providing trial information that is tailored to what parents consider important in making a decision about a clinical trial may improve recruitment practice and ultimately benefit evidence-based paediatric medicine. PMID:23844006

  3. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis: A Meta-Epidemiological Study

    PubMed Central

    Christensen, Anton Wulf; Tarp, Simon; Furst, Daniel E.; Døssing, Anna; Amris, Kirstine; Bliddal, Henning; Taylor, Peter C.; Christensen, Robin

    2015-01-01

    Objective To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs)) for rheumatoid arthritis (RA). Methods We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3–6 and used an add-on design. Odds ratios (ORs) were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR). Results Sixty-two trials (19,923 RA patients) were included in the primary analyses using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI) 3.41 to 4.60). The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower in trials including "DMARD-naïve" patients compared with trials including "DMARD inadequate responders" (ROR = 0.45, 95%CI 0.31 to 0.66) and trials including "targeted therapy inadequate responders" (0.50, 95%CI 0.29 to 0.87), test for interaction: p = 0.0002. Longer mean disease duration was associated with a higher likelihood of responding to treatment (? = 1.05, 95%CI 1.00 to 1.11 OR’s per year; p = 0.03). Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings. Conclusion Our results suggest that a highly selective inclusion is not associated with greater treatment effect, as might otherwise be expected. The added benefit of a targeted therapy was lower in trials including patients who were DMARD-naïve and trials including patients with shorter disease durations. PMID:26360583

  4. Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial

    PubMed Central

    2013-01-01

    Background Osteoarthritis is a relatively common musculoskeletal disorder that increases in prevalence with age. Worldwide, knee osteoarthritis is one of the leading causes of disability, particularly in the elderly. In numerous trials of agents for long-term pain therapy, no well-established and replicable results have been achieved. Complementary and alternative medical approaches have been employed for thousands of years to relieve knee osteoarthritis pain. Among herbal medicines, the golden plaster is the preferred and most commonlyused method in China to reduce pain in patients with knee osteoarthritis, as it causes few adverse effects. The purpose of this study will be to evaluate the efficacy and safety of golden plaster on pain in patients with knee osteoarthritis. Methods/Design This study will be a multicenter randomized, double-blind, placebo-controlled trial. A total of 320 participants aged 45 to 79 years with knee osteoarthritis, whose scores on a visual analog scale (VAS) are more than 20 mm,will be randomly allocated into a treatment group and a control group. A golden plaster will be administered externally to participants in the treatment group for 2 weeks, while the control group will receive a placebo plaster externally for 2 weeks. Follow-up will be at regular intervals during a 4-week period with a VAS score for pain, quality of life, and complications. Discussion This study will be a methodologically sound randomized controlled trial to assess pain relief after the intervention of golden plaster, compared to a placebo intervention in patients with knee osteoarthritis. Trial registration ClinicalTrials.gov identifier: ChiCTR-TRC-13003418 PMID:24220504

  5. Home-based exercise and support programme for people with dementia and their caregivers: study protocol of a randomised controlled trial

    PubMed Central

    2011-01-01

    Background Dementia affects the mood of people with dementia but also of their caregivers. In the coming years, the number of people with dementia will increase worldwide and most of them will continue to live in the community as long as possible. Home-based psychosocial interventions reducing the depressive symptoms of both people with dementia and their caregivers in their own home are highly needed. Methods/Design This manuscript describes the design of a Randomised Controlled Trial (RCT) of the effects of a home-based exercise and support programme for people with dementia and their caregivers. The aim is to randomly assign 156 dyads (caregiver and dementia diagnosed person) to an intervention group or a comparison group. The experimental group receives a home programme in which exercise and support for the people with dementia and their caregivers are combined and integrated. The comparison group receives a minimal intervention. Primary outcomes are physical health (people with dementia) and mood (people with dementia and caregivers). In addition, to get more insight in the working components of the intervention and the impact of the intervention on the relationship of the dyads a qualitative sub-study is carried out. Discussion This study aims to contribute to an evidence-based treatment to reduce depressive symptoms among people with dementia and their caregivers independently living in the community. Trial Registration The study has been registered at the Netherlands National Trial Register (NTR), which is connected to the International Clinical Trials Registry Platform of the WHO. Trial number: NTR1802. PMID:22117691

  6. Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D). Methods/Design A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea. Discussion According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment. Trial registration ChiCTR-TRC-14004241. Date of registration: 9 February 2014. PMID:25002196

  7. A Study of Group Dynamics in Educational Leadership Cohort and Non-Cohort Groups

    ERIC Educational Resources Information Center

    Greenlee, Bobbie J.; Karanxha, Zorka

    2010-01-01

    The purpose of this study was to examine group dynamics of educational leadership students in cohorts and make comparisons with the group dynamics characteristics of non-cohort students. Cohorts have emerged as dynamic and adaptive entities with attendant group dynamic processes that shape collective learning and action. Cohort (n=42) and…

  8. Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Early-onset dementia is common in Down syndrome adults, who have trisomy 21. The amyloid precursor protein gene is on chromosome 21, and so is over-expressed in Down syndrome, leading to amyloid ? (A?) over-production, a major upstream pathway leading to Alzheimer disease (AD). Statins (microsomal 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors), have pleiotropic effects including potentially increasing brain amyloid clearance, making them plausible agents to reduce AD risk. Animal models, human observational studies, and small scale trials support this rationale, however, there are no AD primary prevention trials in Down syndrome adults. In this study we study aim to inform the design of a full-scale primary prevention trial. Methods/Design TOP-COG is a feasibility and pilot double-blind randomized controlled trial (RCT), with a nested qualitative study, conducted in the general community. About 60 Down syndrome adults, aged ?50 will be included. The intervention is oral simvastatin 40mg at night for 12 months, versus placebo. The primary endpoint is recruitment and retention rates. Secondary endpoints are (1) tolerability and safety; (2) detection of the most sensitive neurocognitive instruments; (3) perceptions of Down syndrome adults and caregivers on whether to participate, and assessment experiences; (4) distributions of cognitive decline, adaptive behavior, general health/quality of life, service use, caregiver strain, and sample size implications; (5) whether A?42/A?40 is a cognitive decline biomarker. We will describe percentages recruited from each source, the number of contacts to achieve this, plus recruitment rate by general population size. We will calculate summary statistics with 90% confidence limits where appropriate, for each study outcome as a whole, by treatment group and in relation to baseline age, cognitive function, cholesterol and other characteristics. Changes over time will be summarized graphically. The sample size for a definitive RCT will be estimated under alternative assumptions. Discussion This study is important, as AD is a major problem for Down syndrome adults, for whom there are currently no effective preventions or treatments. It will also delineate the most suitable assessment instruments for this population. Recruitment of intellectually disabled adults is notoriously difficult, and we shall provide valuable information on this, informing future studies. Trial registration Current Controlled Trials ISRCTN Register ID: ISRCTN67338640 (17 November 2011) PMID:24888381

  9. Benchmarking Controlled Trial—a novel concept covering all observational effectiveness studies

    PubMed Central

    Malmivaara, Antti

    2015-01-01

    Abstract The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals. PMID:25965700

  10. Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Cognitive bias modification (CBM) interventions have demonstrated efficacy in augmenting core biases implicated in psychopathology. The current randomized controlled trial (RCT) will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification intervention for obsessive compulsive disorder (OCD) when compared to a control condition. Methods/Design Patients meeting diagnostic criteria for a current or lifetime diagnosis of OCD will be recruited via the research arm of a not-for-profit clinical and research unit in Australia. The minimum sample size for each group (alpha set at 0.05, power at .80) was identified as 29, but increased to 35 to allow for 20% attrition. We will measure the impact of CBM on interpretations bias using the OC Bias Measure (The Ambiguous Scenarios Test for OCD ;AST-OCD) and OC-beliefs (The Obsessive Beliefs Questionnaire-TRIP; OBQ-TRIP). Secondary outcome measures include the Dimensional Obsessive-Compulsive Scale (DOCS), the Patient Health Questionnaire (PHQ-9), The Kessler Psychological Distress Scale (K10), and the Word Sentence Association Test for OCD (WSAO). Change in diagnostic status will be indexed using the OCD Mini International Neuropsychiatric Interview (M.I.N.I) Module at baseline and follow-up. Intent-to-treat (ITT) marginal and mixed-effect models using restricted maximum likelihood (REML) estimation will be used to evaluate the primary hypotheses. Stability of bias change will be assessed at 1-month follow-up. Discussion A limitation of the online nature of the study is the inability to include a behavioral outcome measure. Trial registration The trial was registered on 10 October 2013 with the Australian New Zealand Clinical Trials Registry (ACTRN12613001130752) PMID:24885779

  11. Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

    PubMed

    Provenzano, Elena; Bossuyt, Veerle; Viale, Giuseppe; Cameron, David; Badve, Sunil; Denkert, Carsten; MacGrogan, Gaëtan; Penault-Llorca, Frédérique; Boughey, Judy; Curigliano, Giuseppe; Dixon, J Michael; Esserman, Laura; Fastner, Gerd; Kuehn, Thorsten; Peintinger, Florentia; von Minckwitz, Gunter; White, Julia; Yang, Wei; Symmans, W Fraser

    2015-09-01

    Neoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes after neoadjuvant therapy, and retesting of markers after treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized pathological evaluation and reporting of neoadjuvant breast cancer specimens should improve prognostication for individual patients and allow comparison of treatment outcomes within and across clinical trials. PMID:26205180

  12. Platelet Aggregation Unchanged by Lipoprotein-Associated Phospholipase A2 Inhibition: Results from an In Vitro Study and Two Randomized Phase I Trials

    PubMed Central

    Shaddinger, Bonnie C.; Xu, Yanmei; Roger, James H.; Macphee, Colin H.; Handel, Malcolm; Baidoo, Charlotte A.; Magee, Mindy; Lepore, John J.; Sprecher, Dennis L.

    2014-01-01

    Background We explored the theorized upregulation of platelet-activating factor (PAF)– mediated biologic responses following lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials. Methods and Results Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib (selective Lp-PLA2 inhibitor) or vehicle. This was followed by a randomized, double-blind crossover study in healthy adult men (n?=?26) employing a single-agonist dose assay of platelet aggregation, after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days. This study was followed by a second randomized, double-blind parallel-group trial in healthy adult men (n?=?58) also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations (0–10 µg/ml) for characterizing EC50 values for platelet aggregation for each subject. Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital, Sydney, Australia. EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies, despite Lp-PLA2 inhibition exceeding 90%. An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study (15.4% vs baseline; 95% confidence interval [CI], 3.9–27.0), which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination. Conclusions Lp-PLA2 inhibition does not enhance platelet aggregation. Trial Registration 1) Study 1: ClinicalTrials.gov NCT01745458 2) Study 2: ClinicalTrials.gov NCT00387257 PMID:24475026

  13. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study

    PubMed Central

    Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-01-01

    Objectives To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Design Blinded case-control study. Setting Journals in PubMed. Population 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Main outcome measure Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Results Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); P<0.001). Papers with a discrepancy were significantly more likely to be retracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); P<0.001). In particular, three types of discrepancy arose significantly more frequently in retracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Conclusions Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. PMID:26387520

  14. Effect of race/ethnicity on participation in HIV vaccine trials and comparison to other trials of biomedical prevention

    PubMed Central

    Dhalla, Shayesta; Poole, Gary

    2014-01-01

    Introduction Racial/ethnic minorities are underrepresented in actual HIV vaccine trials in North America, and willingness to participate (WTP) and retention in an HIV vaccine trial may differ from that in Whites. Methods In this review, the authors identified HIV vaccine preparedness studies (VPS) in North America in high-risk populations that examined the relationship between race/ethnicity and WTP in a preventive phase 3 HIV vaccine trial, and the relationship to retention. Studies were categorized by risk group, and comparison group (Whites vs. non-Whites). Other types of trials of biomedical prevention were also identified, and WTP and retention rates were compared and contrasted to actual HIV vaccine trials. Results In the studies identified, WTP in a hypothetical trial HIV vaccine trial did not differ by race/ethnicity. In contrast, actual HIV vaccine trials, an HIV acquisition trial, and a phase 2B preexposure prophylaxis (PrEP) trial have enrolled a large percentage of White men. Human papilloma virus (HPV) privately-funded trials have also enrolled a large number of Whites, due to convenience sampling. Retention in the HIV acquisition trial was lower in African-Americans compared with Whites. Conclusion Strategies to increase WTP and enhanced retention (ER) strategies may help in recruiting and retaining minority participants in actual HIV vaccine trials and other trials of biomedical prevention. PMID:25424807

  15. Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial

    PubMed Central

    Chandrashekhar, B S; Anitha, M.; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir

    2015-01-01

    Background: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. Aim: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. Materials and Methods: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. Results: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. Conclusion: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation. PMID:25738069

  16. Clinical Outcome Analysis in 'High-Risk' Versus 'Low-Risk' Patients Eligible For National Surgical Adjuvant Breast and Bowel B-39/Radiation Therapy Oncology Group 0413 Trial: Five-Year Results

    SciTech Connect

    Patel, Rakesh R. Christensen, Michael E.; Hodge, C. Wesley; Adkison, Jarrod B.; Das, Rupak K.

    2008-03-15

    Purpose: To report the local control and overall survival outcomes after lumpectomy followed by accelerated partial breast irradiation in high-risk patients as defined by the current inclusion criteria for the National Surgical Adjuvant Breast and Bowel B-39/Radiation Therapy Oncology Group 0413 Intergroup trial. Methods and Materials: Between 2000 and 2005, 273 women with early-stage breast cancer were treated using either multicatheter interstitial brachytherapy (n = 247) or MammoSite (n = 26). Patients received 32-34 Gy in 8-10 twice-daily fractions using high-dose-rate {sup 192}Ir brachytherapy. All patients met the initial inclusion criteria for the Intergroup trial and were separated into two groups: high-risk patients (representing the cohort that remained eligible for the Intergroup trial) who satisfied one or more of the 'high-risk' criteria (age <50 years, estrogen receptor negative, and/or positive lymph nodes; n = 90), and low-risk patients who comprised the remainder of the cohort (n = 183). The outcomes of the two cohorts were analyzed and compared. Results: The median follow-up of the entire cohort was 48.5 months. No significant difference was found in outcomes at 5 years between the low- and high-risk groups, with a local control rate of 97.8% vs. 93.6%, crude local recurrence rate of 2.2% (n = 4) vs. 4.4% (n = 4), and overall survival rate of 92.1% vs. 89.5%, respectively. Conclusion: At 5 years, no statistically significant difference was found in outcomes for patients deemed to be at greater risk in the current National Surgical Adjuvant Breast and Bowel B-39/Radiation Therapy Oncology Group 0413 Intergroup trial. These clinical data support the inclusion of this 'high-risk' population in this important ongoing study.

  17. Professional Development within Collaborative Teacher Study Groups: Pitfalls and Promises

    ERIC Educational Resources Information Center

    Stanley, Ann Marie

    2011-01-01

    Teacher study groups are often thought to be effective professional development structures. Such teacher communities may foster teacher learning through a collaborative culture and the codification of group members' collective knowledge. However, not all study groups are effective professional development. This article is a discussion of factors…

  18. U.S. Virtual School Trial Period and Course Completion Policy Study

    ERIC Educational Resources Information Center

    Hawkins, Abigail; Barbour, Michael K.

    2010-01-01

    Variation in policies virtual schools use to calculate course completion and retention rates impacts the comparability of these quality metrics. This study surveyed 159 U.S. virtual schools examining the variability in trial period and course completion policies--two policies that affect course completion rates. Of the 86 respondents, almost 70%…

  19. A randomized controlled trial on errorless learning in goal management training: study rationale and protocol

    PubMed Central

    2013-01-01

    Background Many brain-injured patients referred for outpatient rehabilitation have executive deficits, notably difficulties with planning, problem-solving and goal directed behaviour. Goal Management Training (GMT) has proven to be an efficacious cognitive treatment for these problems. GMT entails learning and applying an algorithm, in which daily tasks are subdivided into multiple steps. Main aim of the present study is to examine whether using an errorless learning approach (preventing the occurrence of errors during the acquisition phase of learning) contributes to the efficacy of Goal Management Training in the performance of complex daily tasks. Methods/Design The study is a double blind randomized controlled trial, in which the efficacy of Goal Management Training with an errorless learning approach will be compared with conventional Goal Management Training, based on trial and error learning. In both conditions 32 patients with acquired brain injury of mixed etiology will be examined. Main outcome measure will be the performance on two individually chosen everyday-tasks before and after treatment, using a standardized observation scale and goal attainment scaling. Discussion This is the first study that introduces errorless learning in Goal Management Training. It is expected that the GMT-errorless learning approach will improve the execution of complex daily tasks in brain-injured patients with executive deficits. The study can contribute to a better treatment of executive deficits in cognitive rehabilitation. Trial registration (Dutch Trial Register): http://NTR3567 PMID:23786651

  20. Designing a Weight Gain Prevention Trial for Young Adults: The CHOICES Study

    ERIC Educational Resources Information Center

    Lytle, Leslie A.; Moe, Stacey G.; Nanney, M. Susie; Laska, Melissa N.; Linde, Jennifer A.; Petrich, Christine A.; Sevcik, Sarah M.

    2014-01-01

    Background: Young adults are at risk for weight gain. Little is known about how to design weight control programs to meet the needs of young adults and few theory-based interventions have been evaluated in a randomized control trial. The Choosing Healthy Options in College Environments and Settings (CHOICES) study was funded to create a…

  1. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  2. Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial

    PubMed Central

    Kim, Kun-Hyung; Kang, Kyung-Won; Jung, Hee-Jung; Park, Ji-Eun; Jung, So-Young; Choi, Jun-Yong; Choi, Sun-Mi

    2008-01-01

    Background Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women's lives. To date, conventional hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical (CAM) approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea. We aim to evaluate the effectiveness of Traditional Korean Acupuncture (TKA) in conjunction with usual care, compared to usual care alone, on hot flushes in perimenopausal and postmenopausal women in Korea. Methods This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score ? 10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and/or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale (MRS), a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants' expectations of acupuncture treatment. Trial registration Current Controlled Trials ISRCTN49335612 PMID:19055763

  3. Comparative Study of Vaginal versus Intramuscular Progesterone in the Prevention of Preterm Delivery: A Randomized Clinical Trial

    PubMed Central

    Bafghi, Afsar Sadat Tabatabaei; Bahrami, Elham; Sekhavat, Leila

    2015-01-01

    Background Preterm birth is a worldwide health concern due to its various negative consequences. Therefore, the prevention of preterm birth is a top priority for healthcare systems in all countries. Objective To compare the effectiveness of vaginal versus intramuscular progesterone in the prevention of preterm delivery. Methods This randomized clinical trial was conducted at Shahid Sadoughi Hospital in Yazd, Iran, from November 21, 2012 to January 20, 2015. Seventy-eight pregnant women with singleton pregnancy and one risk factor of preterm delivery were included in the study. The subjects were assigned randomly to two groups, with group one receiving Cyclogest and group two receiving 17-? hydroxyprogesterone caproate. Subsequently, we analyzed drug complications during pregnancy, delivery time, neonatal outcomes, and patients’ satisfaction among the two groups. The data were analyzed using SPSS version 16. We used descriptive statistics, chi-squared, t-test, and ANOVA for the analyses of primary and secondary outcomes. Results Among the 39 births in group one, 33.3% occurred preterm, and, among the 39 births in group two, 30.7% occurred preterm (< 37 weeks). The mean gestational ages at delivery in groups 1 and 2 were 37.07 ± 2.23 and 36.81 ± 2.77 weeks, respectively (p = 0.765). Other variables were not significantly different between the two groups, including birth weight (p = 0.745), Apgar scores for the first and fifth minutes (p = 0.574, 0.630), length of stay in the neonatal intensive care unit (NICU) when the newborns needed hospitalization (p = 0.358), and the patients’ satisfaction with the drugs that were used (p = 0.615). Conclusions In this study, vaginal progesterone and intramuscular progesterone had the same levels of effectiveness, safety and acceptance by patients in the prevention of preterm delivery. Therefore, both can be used for this purpose in clinical practices, but more studies are needed. PMID:26516434

  4. Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial

    PubMed Central

    2013-01-01

    Background Rheumatoid arthritis (RA) is a chronic inflammatory disorder that leads to joint damage, deformity, and pain. It affects approximately 1% of adults in developed countries. Periodontitis is a chronic oral infection, caused by inflammatory reactions to gram-negative anaerobic bacteria, and affecting about 35 to 50% of adults. If left untreated, periodontitis can lead to tooth loss. A significant association has been shown to exist between periodontitis and RA in observational studies. Some intervention studies have suggested that periodontal treatment can reduce serum inflammatory biomarkers such as C-reactive protein, or erythrocyte sedimentation rate. We hypothesize that periodontitis could be an aggravating factor in patients with RA, and that its treatment would improve RA outcomes. The aim of this clinical trial is to assess the effect of periodontal treatment on the biological and clinical parameters of patients with RA. Methods/design The ESPERA (Experimental Study of Periodontitis and Rheumatoid Arthritis) study is an open-label, randomized, controlled trial. Subjects with both RA and periodontitis will be recruited at two university hospitals in southwestern France. In total, 40 subjects will be randomized into two arms (intervention and control groups), and will be followed up for 3 months. Intervention will consist of full-mouth supra-gingival and sub-gingival non-surgical scaling and root planing, followed by systemic antibiotic therapy, local antiseptics, and oral hygiene instructions. After the 3-month follow-up period, the same intervention will be applied to the subjects randomized to the control group. The primary outcome will be change of in Disease Activity Score in 28 Joints (DAS28) at the end of the follow-up period. Secondary outcomes will be the percentages of subjects with 20%, 50%, and 70% improvement in disease according to the American College of Rheumatology criteria. Health-related quality of life assessments (the Health Assessment Questionnaire and the Geriatric Oral Health Assessment Index) will also be compared between the two groups. Discussion Evidence-based management of potential aggravating factors in subjects with active RA could be of clinical importance, yet there are few randomized controlled trials on the effect of periodontal treatment on the clinical parameters of RA. The ESPERA trial is designed to determine if non-surgical periodontal treatment could improve clinical outcomes in patients with active RA, and the quality of life of these patients. Trial registration The ESPERA Trial was registered in Current Controlled Trials [ISRCTN79186420] on 2012/03/20. The trial started recruiting on 2012/03/06. PMID:23945051

  5. Effectiveness of classroom based crew resource management training in the intensive care unit: study design of a controlled trial

    PubMed Central

    2011-01-01

    Background Crew resource management (CRM) has the potential to enhance patient safety in intensive care units (ICU) by improving the use of non-technical skills. However, CRM evaluation studies in health care are inconclusive with regard to the effect of this training on behaviour and organizational outcomes, due to weak study designs and the scarce use of direct observations. Therefore, the aim of this study is to determine the effectiveness and cost-effectiveness of CRM training on attitude, behaviour and organization after one year, using a multi-method approach and matched control units. The purpose of the present article is to describe the study protocol and the underlying choices of this evaluation study of CRM in the ICU in detail. Methods/Design Six ICUs participated in a paired controlled trial, with one pre-test and two post test measurements (respectively three months and one year after the training). Three ICUs were trained and compared to matched control ICUs. The 2-day classroom-based training was delivered to multidisciplinary groups. Typical CRM topics on the individual, team and organizational level were discussed, such as situational awareness, leadership and communication. All levels of Kirkpatrick's evaluation framework (reaction, learning, behaviour and organisation) were assessed using questionnaires, direct observations, interviews and routine ICU administration data. Discussion It is expected that the CRM training acts as a generic intervention that stimulates specific interventions. Besides effectiveness and cost-effectiveness, the assessment of the barriers and facilitators will provide insight in the implementation process of CRM. Trial registration Netherlands Trial Register (NTR): NTR1976 PMID:22073981

  6. The Chronic Care for Wet Age Related Macular Degeneration (CHARMED) Study: A Randomized Controlled Trial

    PubMed Central

    Markun, Stefan; Dishy, Avraham; Neuner-Jehle, Stefan; Rosemann, Thomas; Frei, Anja

    2015-01-01

    Background In real life, outcomes in wet age related macular degeneration (W-AMD) continue to fall behind the results from randomized controlled trials. The aim of this trial was to assess if outcomes can be improved by an intervention in healthcare organization following recommendations of the Chronic Care Model (CCM). Methods Multi-centered randomized controlled clinical trial. The multifaceted intervention consisted in reorganization of care (delivery by trained chronic care coaches, using reminder systems, performing structured follow-up, empowering patients in self-monitoring and giving decision-support). In the control usual care was continued. Main outcome measures were changes in ETDRS visual acuity, optical coherence tomography (OCT) macular retinal thickness and quality of life (NEI VFQ-25 questionnaire). Results 169 consecutive patients in Swiss ophthalmology centers were included. Mean ETDRS baseline visual acuity of eyes with W-AMD was 57.8 (± 18.7). After 12 months, the between-group difference in mean change of ETDRS visual acuity was -4.8 (95%CI: -10.8 to +1.2, p = 0.15); difference in mean change of OCT was +14.0 (95% CI -39.6 to 67.6, p = 0.60); difference in mean change of NEI VFQ-25 composite score mean change was +2.1(95%CI: -1.3 to +5.5, p = 0.19). Conclusions The intervention aiming at improving chronic care was not associated with favorable outcomes within 12 months. Other approaches need to be tested to close the evidence-performance gap in W-AMD. Trial Registration Controlled-Trials.com ISRCTN32507927 PMID:26569501

  7. Internet-Delivered Targeted Group Intervention for Body Dissatisfaction and Disordered Eating in Adolescent Girls: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Heinicke, Brooke E.; Paxton, Susan J.; McLean, Sian A.; Wertheim, Eleanor H.

    2007-01-01

    This study evaluated a targeted intervention designed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program. The program consisted of six, 90-minute weekly small group, synchronous on-line sessions and was facilitated by a therapist and manual. Participants were…

  8. Effectiveness of a School-Based Group Psychotherapy Program for War-Exposed Adolescents: A Randomized Control Trial

    ERIC Educational Resources Information Center

    Layne, Christopher M.; Saltzman, William R.; Poppleton, Landon; Burlingame, Gary M.; Pasalic, Alma; Durakovic, Elvira; Music, Mirjana; Campara, Nihada; Dapo, Nermin; Arslanagic, Berina; Steinberg, Alan M.; Pynoos, Robert S.

    2008-01-01

    The study assesses the comparative efficacy of a classroom-based psycho-education and skills intervention and a school-based trauma- and grief-focused group treatment of a three-tiered mental health program for adolescents exposed to severe war-trauma, traumatic bereavement, and postwar adversity. The two-tier approach, combined with…

  9. Evaluation of a Group Cognitive-Behavioral Depression Prevention Program for Young Adolescents: A Randomized Effectiveness Trial

    ERIC Educational Resources Information Center

    Gillham, Jane E.; Reivich, Karen J.; Brunwasser, Steven M.; Freres, Derek R.; Chajon, Norma D.; Kash-MacDonald, V. Megan; Chaplin, Tara M.; Abenavoli, Rachel M.; Matlin, Samantha L.; Gallop, Robert J.; Seligman, Martin E. P.

    2012-01-01

    Depression is a common psychological problem in adolescence. Recent research suggests that group cognitive-behavioral interventions can reduce and prevent symptoms of depression in youth. Few studies have tested the effectiveness of such interventions when delivered by school teachers and counselors (as opposed to research team staff). We…

  10. Menaquinone-7 Supplementation to Reduce Vascular Calcification in Patients with Coronary Artery Disease: Rationale and Study Protocol (VitaK-CAC Trial)

    PubMed Central

    Vossen, Liv M.; Schurgers, Leon J.; van Varik, Bernard J.; Kietselaer, Bas L. J. H.; Vermeer, Cees; Meeder, Johannes G.; Rahel, Braim M.; van Cauteren, Yvonne J. M.; Hoffland, Ge A.; Rennenberg, Roger J. M. W.; Reesink, Koen D.; de Leeuw, Peter W.; Kroon, Abraham A.

    2015-01-01

    Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD). Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP). Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA) results in elevated uncarboxylated MGP (ucMGP) and subsequently in extensive arterial calcification. This led us to hypothesize that vitamin K supplementation may slow down the progression of calcification. To test this, we designed the VitaK-CAC trial which analyses effects of menaquinone-7 (MK-7) supplementation on progression of CAC. The trial is a double-blind, randomized, placebo-controlled trial including patients with coronary artery disease (CAD). Patients with a baseline Agatston CAC-score between 50 and 400 will be randomized to an intervention-group (360 microgram MK-7) or a placebo group. Treatment duration will be 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function, and associations with biomarkers. We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD. PMID:26516910

  11. Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1.

    PubMed

    Elm, Jordan J

    2012-10-01

    Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double-blind, parallel-group, placebo-controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long-term Study-1 (LS-1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS-1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS-1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5-year follow-up visit against the background of dopaminergic therapy and best PD care. PMID:23079770

  12. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials And Research group database

    PubMed Central

    Walker, U A; Tyndall, A; Czirják, L; Denton, C; Farge?Bancel, D; Kowal?Bielecka, O; Müller?Ladner, U; Bocelli?Tyndall, C; Matucci?Cerinic, M

    2007-01-01

    Background Systemic sclerosis (SSc) is a multisystem autoimmune disease, which is classified into a diffuse cutaneous (dcSSc) and a limited cutaneous (lcSSc) subset according to the skin involvement. In order to better understand the vascular, immunological and fibrotic processes of SSc and to guide its treatment, the EULAR Scleroderma Trials And Research (EUSTAR) group was formed in June 2004. Aims and methods EUSTAR collects prospectively the Minimal Essential Data Set (MEDS) on all sequential patients fulfilling the American College of Rheumatology diagnostic criteria in participating centres. We aimed to characterise demographic, clinical and laboratory characteristics of disease presentation in SSc and analysed EUSTAR baseline visits. Results In April 2006, a total of 3656 patients (1349 with dcSSc and 2101 with lcSSc) were enrolled in 102 centres and 30 countries. 1330 individuals had autoantibodies against Scl70 and 1106 against anticentromere antibodies. 87% of patients were women. On multivariate analysis, scleroderma subsets (dcSSc vs lcSSc), antibody status and age at onset of Raynaud's phenomenon, but not gender, were found to be independently associated with the prevalence of organ manifestations. Autoantibody status in this analysis was more closely associated with clinical manifestations than were SSc subsets. Conclusion dcSSc and lcSSc subsets are associated with particular organ manifestations, but in this analysis the clinical distinction seemed to be superseded by an antibody?based classification in predicting some scleroderma complications. The EUSTAR MEDS database facilitates the analysis of clinical patterns in SSc, and contributes to the standardised assessment and monitoring of SSc internationally. PMID:17234652

  13. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. The 2014 Clinical Trial Design Working Group Report.

    PubMed

    Martin, Paul J; Lee, Stephanie J; Przepiorka, Donna; Horowitz, Mary M; Koreth, John; Vogelsang, Georgia B; Walker, Irwin; Carpenter, Paul A; Griffith, Linda M; Akpek, Gorgun; Mohty, Mohamad; Wolff, Daniel; Pavletic, Steven Z; Cutler, Corey S

    2015-08-01

    Treatment of chronic graft-versus-host disease is intended to produce a sustainable benefit by reducing symptom burden, controlling objective manifestations of disease activity, preventing damage and impairment, and improving overall survival without causing disproportionate harms related to the treatment itself. Successful management can control the disease until systemic treatment is no longer needed. The complexity of the disease, the extended duration of follow-up needed to observe disease resolution and withdrawal of immunosuppressive treatment, and the lack of fully developed shorter term endpoints impede progress in the field. Identification and characterization of primary endpoints demonstrating clinical benefit without requiring years of follow-up is urgently needed, with the understanding that clinical benefit encompasses not only the self-evident benefit of the primary endpoint but also any other associated benefits. This report discusses regulatory considerations, eligibility criteria, the value of controlled trial designs, the merits of proposed primary endpoints, and key considerations elaborated from experience and progress during the past decade. The report concludes by mapping an overall approach that could support and lead to maximally informative clinical trials, especially those that seek to demonstrate clinical benefit along a pathway to regulatory review and approval. PMID:25985921

  14. Incorporating group correlations in genome-wide association studies using smoothed group Lasso

    PubMed Central

    Liu, Jin; Huang, Jian; Ma, Shuangge; Wang, Kai

    2013-01-01

    In genome-wide association studies, penalization is an important approach for identifying genetic markers associated with disease. Motivated by the fact that there exists natural grouping structure in single nucleotide polymorphisms and, more importantly, such groups are correlated, we propose a new penalization method for group variable selection which can properly accommodate the correlation between adjacent groups. This method is based on a combination of the group Lasso penalty and a quadratic penalty on the difference of regression coefficients of adjacent groups. The new method is referred to as smoothed group Lasso (SGL). It encourages group sparsity and smoothes regression coefficients for adjacent groups. Canonical correlations are applied to the weights between groups in the quadratic difference penalty. We first derive a GCD algorithm for computing the solution path with linear regression model. The SGL method is further extended to logistic regression for binary response. With the assistance of the majorize–minimization algorithm, the SGL penalized logistic regression turns out to be an iteratively penalized least-square problem. We also suggest conducting principal component analysis to reduce the dimensionality within groups. Simulation studies are used to evaluate the finite sample performance. Comparison with group Lasso shows that SGL is more effective in selecting true positives. Two datasets are analyzed using the SGL method. PMID:22988281

  15. Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in west Africa?

    PubMed

    Lanini, Simone; Zumla, Alimuddin; Ioannidis, John P A; Di Caro, Antonino; Krishna, Sanjeev; Gostin, Lawrence; Girardi, Enrico; Pletschette, Michel; Strada, Gino; Baritussio, Aldo; Portella, Gina; Apolone, Giovanni; Cavuto, Silvio; Satolli, Roberto; Kremsner, Peter; Vairo, Francesco; Ippolito, Giuseppe

    2015-06-01

    The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24,900 cases and about 10,300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use. However, non-randomised studies might not yield valid conclusions, leading to large residual uncertainty about how to interpret the results, and can also waste scarce intervention-related resources, making them profoundly unethical. Scientifically sound and rigorous study designs, such as adaptive RCTs, could provide the best way to reduce the time needed to develop new interventions and to obtain valid results on their efficacy and safety while preserving the application of ethical precepts. We present an overview of clinical studies registered at present at the four main international trial registries and provide a simulation on how adaptive RCTs can behave in this context, when mortality varies simultaneously in either the control or the experimental group. PMID:25881871

  16. Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

    PubMed Central

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

    2014-01-01

    Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

  17. The GoodNight study—online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Cognitive Behaviour Therapy for Insomnia (CBT-I) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia. CBT-I also lowers levels of depression in this group. However, it is not known if targeting insomnia using CBT-I will lower depressive symptoms, and thus reduce the risk of major depressive episode onset, in those specifically at risk for depression. Therefore, this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression. Method/design A sample of 1,600 community-dwelling adults (aged 18–64), who screen positive for both subclinical levels of depressive symptoms and insomnia, will be recruited via various media and randomised to either a 9-week online insomnia treatment programme, Sleep Healthy Using The internet (SHUTi), or an online attention-matched control group (HealthWatch). The primary outcome variable will be depression symptom levels at the 6-month post-intervention on the Patient Heath Questionnaire-9 (PHQ-9). A secondary outcome will be onset of major depressive episodes assessed at the 6-month post-intervention using ‘current’ and ‘time from intervention’ criteria from the Mini International Neuropsychiatric Interview. Discussion This trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression. If effective, online provision of a depression prevention programme will facilitate dissemination. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12611000121965. PMID:24524214

  18. Do messages of scarcity increase trial recruitment? | accrualnet.cancer.gov

    Cancer.gov

    The intervention group in this randomized study were given reminders about a smoking cessation trial and told that a limited number of places were available. The control group was given the same reminder without a message indicating scarcity of places in the trial. Both groups were individuals who had once indicated interest but had not yet made a decision. The enrollment rate for the intervention group was 10.1 percent; 6.9 percent of the control group joined the trial.

  19. [Controlled randomized clinical trials].

    PubMed

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the primary outcome. One may choose either a single endpoint (for instance all-cause mortality; or a composite criterion taking into account various manifestations of the same health disorder (for instance cardiovascular mortality plus non lethal myocardial infarction plus non lethal ischemic stroke). The trial must be controlled, i.e. must compare the intervention with a standard or dummy treatment. A randomization process is used to ensure that the groups are comparable. The patients must be monitored and the results analyzed in double-blind manner The required number of patients is calculated based on the working hypothesis ("superiority" trial or "equivalence" trial), as well as the spontaneous variability of the main endpoint, and the alpha and beta statistical risks. The experimental design (cross-over or parallel groups) is chosen according to the primary outcome measure and the disease characteristics. Finally, the results must be analyzed in an intention-to-treat manner, taking into account all the patients who were initially randomized. The results of these methodologically sound trials form the basis for official therapeutic guidelines, which help physicians to choose the best treatments for their patients. However, extrapolating the results of randomized controlled clinical trials to the general patient population is not always straightforward. For instance, it is well known that patients who participate in clinical trials are highly selected and therefore somewhat unrepresentative. In addition, their numbers are limited and the treatment period is often much shorter than in routine management of a chronic disease. Finally, patients in clinical trials are monitored more closely than in routine practice. This is why we need post-marketing pharmacoepidemiological studies, in which cohorts of patients exposed to the treatment in question are monitored sufficiently long to determine the precise risk-benefit ratio. Controlled clinical trials are lacking in various fields of biomedical research, either because drug companies consi

  20. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Septic shock is common and has unacceptably high morbidity, mortality, and associated cost with numerous failed attempts at developing effective therapies. Endotoxin, one of the most potent mediators of sepsis, is found in high levels in approximately 50% of patients with septic shock. Polymyxin B (PMX) hemoperfusion has been shown in numerous studies to successfully remove endotoxin and potentially improve outcomes. EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) is a theragnostic trial (matching blood measurement to treatment capability) of PMX hemoperfusion in patients with septic shock and confirmed endotoxemia as measured by the endotoxin activity assay (EAA). Methods EUPHRATES is a pivotal regulatory trial that is multi-centered, placebo-controlled and blinded. The trial is being conducted in fifty ICUs in the United States and Canada and is powered to enroll 360 patients. Patients with persistent septic shock despite adequate fluid resuscitation on vasopressors for more than 2 and less than 30 hours are eligible for measurement of the EAA. Those with EAA ?0.60 are eligible to be randomized to treatment with two sessions of PMX hemoperfusion 24 hours apart. The primary endpoint for the trial is 28-day all-cause mortality. Discussion Unique features of the trial include absence of systemic inflammatory response (SIRS) criteria as a requirement for inclusion, use of the EAA to confirm endotoxemia as a requisite for treatment, and use of a detailed “façade” hemoperfusion event as a blinding mechanism. The outcomes of the second interim analysis included a resizing of the trial to 650 patients and the addition of an exclusion criterion of subjects with multiple organ dysfunction score (MODS)???9. Results are anticipated in 2016. Trial registration Clinicaltrials.gov identifier: NCT01046669. Registered: January 8, 2010. PMID:24916483

  1. Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Pain and agitation are common in patients after craniotomy. They can result in tachycardia, hypertension, immunosuppression, increased catecholamine production and increased oxygen consumption. Dexmedetomidine, an alpha-2 agonist, provides adequate sedation without respiratory depression, while facilitating frequent neurological evaluation. Methods/design The study is a prospective, randomized, double-blind, controlled, parallel-group design. Consecutive patients are randomly assigned to one of the two treatment study groups, labeled ‘Dex group’ or ‘Saline group.’ Dexmedetomidine group patients receive a continuous infusion of 0.6 ?g/kg/h (10 ug/ml). Placebo group patients receive a maintenance infusion of 0.9% sodium chloride for injection at a volume and rate equal to that of dexmedetomidine. The mean percentages of time in optimal sedation, vital signs, various and adverse events, the percentage of patients requiring propofol for rescue to achieve/maintain targeted sedation (Sedation-Agitation Scale, SAS 3 to 4) and total dose of propofol required throughout the study drug infusion are collected. The percentage of patients requiring fentanyl for additional rescue to analgesia and total dose of fentanyl required are recorded. The effects of dexmedetomidine on hemodynamic and recovery responses during extubation are measured. Intensive care unit and hospital length of stay also are collected. Plasma levels of epinephrine, norepinephrine, dopamine, cortisol, neuron-specific enolase and S100-B are measured before infusion (T1), at two hours (T2), four hours (T3) and eight hours (T4) after infusion and at the end of infusion (T5) in 20 patients in each group. Discussion The study has been initiated as planned in July 2012. One interim analysis advised continuation of the trial. The study will be completed in July 2013. Trial registration ClinicalTrials (NCT): ChiCTR-PRC-12002903. PMID:23941549

  2. Influence of time after extraction on the development of gingival invagination: study protocol for a multicenter pilot randomized controlled clinical trial

    PubMed Central

    2013-01-01

    Background Gingival invaginations are a common side effect of orthodontic therapy involving tooth extraction and subsequent space closure. Consequences of gingival invaginations are a jeopardized stability of the space closure and hampered oral hygiene. In a retrospective study, the factor time until initiation of orthodontic space closure after tooth extraction has been identified as a potential risk factor for the development of gingival invaginations. The aim of this pilot study is to proof this hypothesis and to enable a caseload calculation for further clinical trials. The referring question is: is it possible to reduce the number of developing gingival invaginations by initiation of orthodontic space closure after tooth extraction at an early point of time? Design The intended pilot study is designed as a multicenter randomized controlled clinical trial, comparing the impact of two different time intervals from tooth extraction to initiation of orthodontic space closure on the development of gingival invaginations. Forty participants, men and women in the age range of 11 to 30 years with orthodontically related indication for tooth extraction in the lower jaw, will be randomized 1:1 in one of two treatment groups. In group A the orthodontic tooth movement into the extraction area will be initiated in a time interval 2 to 4 weeks after tooth extraction. In group B the tooth movement will be initiated in a time interval >12 weeks after extraction. A possible effect of these treatment modalities on the development of gingival invaginations will be documented at the moment of space closure or 10 months +/- 14 days after initiation of space closure respectively, by clinical documentation of the primary (reduced number of gingival invagination) and the secondary endpoint (reduction of the severity of gingival invaginations). Trial registration Universal Trial Number U1111-1132-6655; German Clinical Trials Register DRKS00004248 PMID:23782625

  3. What Makes Group MET Work? A Randomized Controlled Trial of College Student Drinkers in Mandated Alcohol Diversion

    PubMed Central

    LaChance, Heather; Feldstein Ewing, Sarah W.; Bryan, Angela D.; Hutchison, Kent E.

    2009-01-01

    Nationally, college drinkers exhibit the highest rates of alcohol consumption and represent the largest percentage of problem drinkers. Group motivational enhancement therapy (GMET) has been found to catalyze problem drinking reductions among college student samples. While research supporting the use of single-session GMET in college samples (general and mandated) is emergent, no studies have evaluated a comprehensive model of the potential active ingredients of this group intervention. College students (N = 206; 88% Caucasian; 63% male; M age = 18.6) mandated to a university alcohol diversion program were randomly assigned to one of three conditions: the standard-of-care two-session ‘Focus on Alcohol Concerns’ education group (FAC), a single group motivational enhancement therapy (GMET), or a single Alcohol Information-only control group (AI) to evaluate the role of five putative mediators: readiness to change, self-efficacy, perceived risk, norm estimates, and positive drinking expectancies. At three and six month follow-ups, GMET students demonstrated greater reductions in problem drinking outcomes (drinks per drinking day, hazardous drinking symptoms, and alcohol-related problems). Of the five mediators proposed, only self-efficacy emerged as a significant mediator. PMID:20025366

  4. Barriers and Facilitators to Enrollment in Cancer Clinical Trials: Qualitative Study of the Perspectives of Clinical Research Associates | accrualnet.cancer.gov

    Cancer.gov

    The authors conducted focus groups of Clinical Research Associates (CRAs) to explore their views on barriers and facilitators to clinical trials accrual. CRAs considered “system-related factors” to have the greatest impact on clinical trials accrual as compared to patient- or physician-related factors. They pointed to increasing trial demands with tight timelines as a major impediment.

  5. To tweet or not to tweet about schizophrenia systematic reviews (TweetSz): study protocol for a randomised controlled trial

    PubMed Central

    Jayaram, Mahesh; Bodart, Angelique Y M; Sampson, Stephanie; Zhao, Sai; Montgomery, Alan A; Adams, Clive E

    2015-01-01

    Introduction The Cochrane Schizophrenia Group (CSzG) has produced and maintained systematic reviews of effects of interventions for schizophrenia and related illness. Each review has a Plain Language Summary (PLS), for those without specialised knowledge, and an abstract, which are freely available from The Cochrane Library (https://summaries.cochrane.org). Increasingly, evidence is being distributed using social media such as Twitter and Weibo (in China) alongside traditional publications. Methods and analysis In a prospective two-arm, parallel, open randomised controlled trial with a 1:1 allocation ratio, we will allocate 170 published systematic reviews into the intervention group (tweeting arm/Weibo arm) versus the control group (non-tweeting arm). Reviews will be stratified by baseline access activity, defined as high (?19 views per week, n=14), medium (4.3 to 18.99 views per week, n=72) or low (<4.3 views per week, n=84), based on Google Analytics, which will also be used for evaluating outcomes. The intervention group wil