http://www.trialsjournal.com The latest research articles published by Trials 2010-02-08T00:00:00Z This is an RSS newsfeed from BioMed Central It is intended to be used with an RSS reader. For more information about RSS newsfeeds from BioMed Central, visit http://www.biomedcentral.com/info/about/rss/ Background: Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. Secondary objectives include a comparison of the cost-effectiveness of the treatments, and an investigation of time to clearance of verrucae, recurrence/clearance of verrucae at six months, patient satisfaction with treatment, pain associated with treatment, and use of painkillers for the treatments. Methods: This is an open, pragmatic, multicentre, randomised controlled trial with two parallel groups: cryotherapy using liquid nitrogen delivered by a healthcare professional for a maximum of 4 treatments (treatments 2-3 weeks apart) or daily self-treatment with 50% salicylic acid for a maximum of 8 weeks. Two hundred and sixty-six patients aged 12 years and over with a verruca are being enrolled into the study. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks compared with baseline and assessed by an independent healthcare professional. Secondary outcomes include self-reported time to clearance of verrucae, self-reported clearance of verrucae at 6 months, cost-effectiveness of the treatments compared to one another, and patient acceptability of both treatments including possible side effects such as pain. The primary analysis will be intention to treat. It is planned that recruitment will be completed by December 2009 and results will be available by June 2010.Trial registrationCurrent Controlled Trials ISRCTN18994246. http://www.trialsjournal.com/content/11/1/12 The Trial Team Sarah Cockayne Trials 2010, 11:12 2010-02-08T00:00:00Z doi:10.1186/1745-6215-11-12 Trials 1745-6215 11 12 2010-02-08T00:00:00Z PDF Background: There are controversies about the most effective treatment to eradicate first growth of Pseudomonas aeruginosa (P aeruginosa) from the lower airways of patients with cystic fibrosis (CF). UK guidelines recommend oral treatment, but some advocate intravenous (IV) treatment. The objective of this study was to assess the feasibility of conducting a randomised controlled trial comparing two treatment strategies to eradicate P aeruginosa in CF patients.Methods/Principal FindingsTwo surveys were conducted. Survey (1) included clinicians who were responsible for the treatment of individuals with CF, to assess their clinical practice, opinions and numbers of potentially eligible patients. Survey (2) included adults and young people aged 13 years or more with CF and parents of children with CF aged less than 13 years, identified at six UK CF centres, who fulfilled eligibility criteria for the proposed clinical trial, to assess their views about the interventions and their willingness to participate in the trial. Generally clinicians treat first or new growth of P aeruginosa with oral antibiotics, but 90% reported that they would consider IV treatment of first isolation of P. aeruginosa. 74% of clinicians would consider recruiting their patients and 45% of consumers would consider entry for themselves or their children into a trial comparing oral with intravenous antibiotics. The median rate per annum for first or new growths of P aeruginosa in adults was 3% (range 1% to 9%) and in children was 10% (range 3% to 23%). If the trial was conducted across the UK, with a consent rate of 45%, then the number of eligible patients per annum who would be willing to take part in a study would be approximately 41 adults and 203 children. Conclusions: This work demonstrates the importance of feasibility studies in preparation for multicentre clinical trials. It confirmed the uncertainty amongst clinicians and patients about the clinical question, enabled assessment of the number of potentially eligible patients, the proportion of patients and clinicians prepared to participate and aspects of trial design which might encourage this. It showed that a clinical trial was feasible, but only if patients were recruited from across United Kingdom. http://www.trialsjournal.com/content/11/1/11 Helen Hickey Ashley Jones Warren Lenney Paula Williamson Rosalind Smyth Trials 2010, 11:11 2010-02-05T00:00:00Z doi:10.1186/1745-6215-11-11 Trials 1745-6215 11 11 2010-02-05T00:00:00Z PDF Background: Performance of primary school students in India lags far below government expectations, and major disparity exists between rural and urban areas. The Naandi Foundation has designed and implemented a programme using community members to deliver after-school academic support for children in over 1,100 schools in five Indian states. Assessments to date suggest that it might have a substantial effect. This trial aims to evaluate the impact of this programme in villages of rural Andhra Pradesh and will compare test scores for children in three arms: a control and two intervention arms. In both intervention arms additional after-school instruction and learning materials will be offered to all eligible children and in one arm girls will also receive an additional 'kit' with a uniform and clothes. Methods: The trial is a cluster-randomised controlled trial conducted in conjunction with the CHAMPION trial. In the CHAMPION trial 464 villages were randomised so that half receive health interventions aiming to reduce neonatal mortality. STRIPES will be introduced in those CHAMPION villages which have a public primary school attended by at least 15 students at the time of a baseline test in 2008. 214 villages of the 464 were found to fulfil above criteria, 107 belonging to the control and 107 to the intervention arm of the CHAMPION trial. These latter 107 villages will serve as control villages in the STRIPES trial. A further randomisation will be carried out within the 107 STRIPES intervention villages allocating half to receive an additional kit for girls on the top of the instruction and learning materials. The primary outcome of the trial is a composite maths and language test score.DiscussionThe study is designed to measure (i) whether the educational intervention affects the exam score of children compared to the control arm, (ii) if the exam scores of girls who receive the additional kit are different from those of girls living in the other STRIPES intervention arm. One of the goals of the STRIPES trial is to provide benefit to the controls of the CHAMPION trial. We will also conduct a cost-benefit analysis in which we calculate the programme cost for 0.1 standard deviation improvement for both intervention arms.Trial RegistrationCurrent controlled trials ISRCTN69951502 http://www.trialsjournal.com/content/11/1/10 Alex Eble Vera Mann Preetha Bhakta Rashmi Lakshminarayana Chris Frost Diana Elbourne Peter Boone Trials 2010, 11:10 2010-02-01T00:00:00Z doi:10.1186/1745-6215-11-10 Trials 1745-6215 11 10 2010-02-01T00:00:00Z PDF In recognition of the benefits of transparent reporting, many peer-reviewed journals require that their authors be prepared to share their raw, unprocessed data with other scientists and/or state the availability of raw data in published articles. But little information on how data should be prepared for publication - or sharing - has emerged. In clinical research patient privacy and consent for use of personal health information are key considerations, but agreed-upon definitions of what constitutes anonymised patient information do not appear to have been established. We aim to address this issue by providing practical guidance for those involved in the publication process, by proposing a minimum standard for de-identifying datasets for the purposes of publication in a peer-reviewed biomedical journal, or sharing with other researchers. Basic advice on file preparation is provided along with procedural guidance on prospective and retrospective publication of raw data, with an emphasis on randomised controlled trials.In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal web sites. http://www.trialsjournal.com/content/11/1/9 Iain Hrynaszkiewicz Melissa Norton Andrew Vickers Douglas Altman Trials 2010, 11:9 2010-01-29T00:00:00Z doi:10.1186/1745-6215-11-9 Trials 1745-6215 11 9 2010-01-29T00:00:00Z PDF Background: Depression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocysteine (tHcy), but the results of randomized trials to date have been unable to show that lowering tHcy through the supplementation of vitamins B6, B12 and folate benefits depressive symptoms. We designed the B-VITAGE trial to determine whether adjunctive treatment with vitamins B6, B12 and folate increases the efficacy of standard antidepressant treatment. Methods: The B-VITAGE trial is a 12-month randomized, double-blind, placebo-controlled trial of daily citalopram (20 to 40 mg) plus B12 (0.4 mg), B6 (25 mg) and folic acid (2 mg) or citalopram (20 to 40 mg) plus placebo for the treatment of depression in later life. The trial aims to recruit over 300 older adults with major depression (DSM-IV) and has been powered to detect the impact of an intervention associated with moderate effect size. Depressive symptoms will be rated with the Montgomery-Asberg Depression Rating Scale (MADRS). The trial has two main outcomes of interest: a reduction of 50% or more in the MADRS total score between baseline and week 12 and the remission of the depressive episode at weeks 12, 26 and 52 according to DSM-IV criteria. We hypothesize that subjects randomly allocated to the vitamin arm of the study will be more likely to show a clinically significant improvement and achieve and maintain remission of symptoms at 12, 26 and 52 weeks. Secondary outcomes of interest include compliance with treatment, reduction in the severity of depressive symptoms, switching to different antidepressants, the use of non-pharmacological antidepressant treatments, response to treatment according to MTHFRC677T genotype, and changes in cognitive function over 52 weeks. Conclusions: The results of this trial will clarify whether the systematic use of B-vitamins improves the response of older adults to standard antidepressant treatment. We anticipate that our findings will have implications for clinical practice and health policy development.Trial RegistrationThe trial is registered with the Australian Clinical Trials Registry,trial number ACTRN12609000256279. http://www.trialsjournal.com/content/11/1/8 Andrew Ford Leon Flicker Kieran McCaul Frank Van Bockxmeer Sarah Hegarty Varsha Hirani Stephen Fenner Osvaldo Almeida Trials 2010, 11:8 2010-01-25T00:00:00Z doi:10.1186/1745-6215-11-8 Trials 1745-6215 11 8 2010-01-25T00:00:00Z PDF Background: New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established.AimsThe primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting. Methods: A cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years) will be randomly selected for detailed follow-up about their illness absences, providing a total of 3400 pupils. In addition, absence information will be collected on all children from the school rolls. Investigators not involved in the running of the trial, outcome assessors, and the statistician will be blinded to the group allocation until the analysis is completed.Trial registration: ACTRN12609000478213 http://www.trialsjournal.com/content/11/1/7 Joanne McKenzie Patricia Priest Rick Audas Marion Poore Cheryl Brunton Lesley Reeves Trials 2010, 11:7 2010-01-23T00:00:00Z doi:10.1186/1745-6215-11-7 Trials 1745-6215 11 7 2010-01-23T00:00:00Z PDF Background: Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population and previous studies have demonstrated only modest, short-term improvements in activity levels with intervention.Design/Methods:Pragmatic 3 arm parallel design cluster controlled trial of class-based exercise (FAME), home-based exercise (OEP) and usual care amongst older people (aged 65 years and over) in primary care. The primary outcome is the achievement of recommended physical activity targets 12 months after cessation of intervention. Secondary outcomes include functional assessments, predictors of exercise adherence, the incidence of falls, fear of falling, quality of life and continuation of physical activity after intervention, over a two-year follow up. An economic evaluation including participant and NHS costs will be embedded in the clinical trial.DiscussionThe ProAct65 trial will explore and evaluate the potential for increasing physical activity among older people recruited through general practice. The trial will be conducted in a relatively unselected population, and will address problems of selective recruitment, potentially low retention rates, variable quality of interventions and falls risk.Trial Registration: ISRCTN43453770 http://www.trialsjournal.com/content/11/1/6 Steve Iliffe Denise Kendrick Richard Morris Dawn Skelton Heather Gage Susie Dinan Zoe Stevens Mirilee Pearl Tahir Masud Trials 2010, 11:6 2010-01-18T00:00:00Z doi:10.1186/1745-6215-11-6 Trials 1745-6215 11 6 2010-01-18T00:00:00Z PDF Background: Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of health care resources, and have a major negative economic and social impact through days lost at work, support for disability, and coping with the psychological consequences of illness. Several registries have shown that evidence based treatments are under-utilised in this patient population, particularly in high-risk patients. There is evidence that systematic educational programmes can lead to improvement in the management of these patients. Since application of the results of important clinical trials and expert clinical guidelines into clinical practice leads to improved patient care and outcomes, we propose to test a quality improvement programme in a general group of hospitals in Europe. Methods: This will be a multi-centre cluster-randomised study in 5 European countries: France, Spain, Poland, Italy and the UK. Thirty eight hospitals will be randomised to receive a quality improvement programme or no quality improvement programme. Centres will enter data for all eligible non-ST segment elevation acute coronary syndrome patients admitted to their hospital for a period of approximately 10 months onto the study database and the sample size is estimated at 2,000-4,000 patients. The primary outcome is a composite of eight measures to assess aggregate potential for improvement in the management and treatment of this patient population (risk stratification, early coronary angiography, anticoagulation, beta-blockers, statins, ACE-inhibitors, clopidogrel as a loading dose and at discharge). After the quality improvement programme, each of the eight measures will be compared between the two groups, correcting for cluster effect.DiscussionIf we can demonstrate important improvements in the quality of patient care as a result of a quality improvement programme, this could lead to a greater acceptance that such programmes should be incorporated into routine health training for health professionals and hospital managers.Trial registration: Clinicaltrials.gov NCT00716430 http://www.trialsjournal.com/content/11/1/5 Marcus Flather Jean Booth Daphne Babalis Hector Bueno Phillipe Steg Grzegorz Opolski Filippo Ottani Jacques Machecourt Alfredo Bardaji Mats Bojestig Anthony Brady Bertil Lindahl Trials 2010, 11:5 2010-01-14T00:00:00Z doi:10.1186/1745-6215-11-5 Trials 1745-6215 11 5 2010-01-14T00:00:00Z PDF Background: The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes.Method/Design: Participants (N=287) were randomly assigned to one of three groups consisting of the following intervention strategies: (1) standard printed PA educational materials provided by the Canadian Diabetes Association [i.e., Group 1/ control group)]; (2) standard printed PA educational materials as in Group 1, pedometers, a log book and printed PA information matched to individuals' PA stage of readiness provided every 3 months (i.e., Group 2); and (3) PA telephone counseling protocol matched to PA stage of readiness and tailored to personal characteristics, in addition to the materials provided in Groups 1 and 2 (i.e., Group 3). PA behaviour measured by the Godin Leisure Time Exercise Questionnaire and related social-cognitive measures were assessed at baseline, 3, 6, 9, 12 and 18-months (i.e., 6-month follow-up). Clinical (biomarkers) and health-related quality of life assessments were conducted at baseline, 12-months, and 18-months. Linear Mixed Model (LMM) analyses will be used to examine time-dependent changes from baseline across study time points for Groups 2 and 3 relative to Group 1.DiscussionADAPT will determine whether tailored but low-cost interventions can lead to sustainable increases in PA behaviours. The results may have implications for practitioners in designing and implementing theory-based physical activity promotion programs for this population.Clinical Trials Registration: ClinicalTrials.gov identifier: NCT00221234 http://www.trialsjournal.com/content/11/1/4 Ronald Plotnikoff Kerry Courneya Ronald Sigal Jeffrey Johnson Nicholas Birkett David Lau Kim Raine Steven Johnson Nandini Karunamuni Trials 2010, 11:4 2010-01-12T00:00:00Z doi:10.1186/1745-6215-11-4 Trials 1745-6215 11 4 2010-01-12T00:00:00Z PDF Background: Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patients. Current treatment (e.g. beta blockers and elective surgery) does postpone but cannot prevent aortic complications in these patients. Recent studies have found Transforming Growth Factor beta (TGF beta) to be involved in the aortic aneurysm formation. Losartan, an Angiotensin II type 1 receptor blocker inhibits TGFbeta in a mouse model of Marfan syndrome leading to inhibition of aortic growth. The main objective of this trial is to assess whether losartan treatment leads to a clinically relevant decrease of aortic dilatation in adult patients with Marfan syndrome. Methods: COMPARE study (COzaar in Marfan Patients Reduces aortic Enlargement) is an open-label, randomized, controlled trial with blinded end-points. Treatment with losartan will be compared with no additional treatment after 3 years of follow-up. We will enroll 330 patients with MFS who will be randomly assigned to receive losartan or not. Patients taking beta-blockers will continue taking their standard treatment. The primary end-point is the largest change in aortic diameter at any aortic level measured by means of MRI. Secondary end-points are change in mortality, incidence of dissection, elective aortic surgery, aortic volume, aortic stiffness and ventricular function. We will also investigate gene and protein expression change in the skin under losartan therapy and create prediction models for losartan-treatment response and aortic dilatation.DiscussionThe COMPARE study will provide important evidence of effects of losartan treatment in adult Marfan patient population. We expect losartan to significantly reduce the occurrence and progression of aortic dilatation. This trial investigates a wide spectrum of clinical, genetic and biochemical effects of losartan aiming to provide further insight in the pathogenesis and treatment of Marfan syndrome.Trial registrationNetherlands Trial Register NTR1423. http://www.trialsjournal.com/content/11/1/3 Teodora Radonic Piet de Witte Marieke Baars Aeilko Zwinderman Barbara Mulder Maarten Groenink Compare Study group Trials 2010, 11:3 2010-01-12T00:00:00Z doi:10.1186/1745-6215-11-3 Trials 1745-6215 11 3 2010-01-12T00:00:00Z PDF