Trials via MedWorm.com

Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial

Trials — Wed, 08 Feb 2012 05:00:00 +0100

DiscussionIn light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation of the efficacy of high-dose vitamin D supplementation in MS patients. The study design presented here fulfills the criteria of a high-quality clinical phase II trial in MS.Trial Registration: ClinicalTrials.gov Identifier: NCT01440062 (Source: Trials)

MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial.

Trials — Tue, 07 Feb 2012 05:00:00 +0100

In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods: Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n=477) or placebo at 14 weeks (n=477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At deliver...

Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

Trials — Tue, 07 Feb 2012 05:00:00 +0100

This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia.Methods/ Design: This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of th...

The effectiveness of a trauma-focused psycho-educational secondary prevention program for children exposed to interparental violence: study protocol for a randomized controlled trial

Trials — Mon, 06 Feb 2012 05:00:00 +0100

This study is a prospective multicenter randomized controlled trial across cities in the Netherlands. Participants (N = 140) are referred to the secondary preventive intervention program by police, social work, women shelters and youth (mental health) care. Children, aged 6-12 years, and their parents, who experienced interparental violence are randomly assigned to either the intervention program or the control program. The control program is comparable on nonspecific factors by offering positive attention, positive expectations, recreation, distraction, warmth and empathy of the therapist, and social support among group participants, in ways that are similar to the intervention program. Primary outcome measures are posttraumatic stress symptoms and emotional and behavioral problems of the...

Comparison of embedded and added motor imagery training in patients after stroke: results of a randomised controlled pilot trial

Trials — Mon, 23 Jan 2012 05:00:00 +0100

Background: Motor imagery (MI) when combined with physiotherapy can offer functional benefits after stroke. Two MI integration strategies exist: added and embedded MI. Both approaches were compared when learning a complex motor task (MT): 'Going down, laying on the floor, and getting up again'. Methods: Outpatients after first stroke participated in a single-blinded, randomised controlled trial with MI embedded into physiotherapy (EG1), MI added to physiotherapy (EG2), and a control group (CG). All groups participated in six physiotherapy sessions. Primary study outcome was time (sec) to perform the motor task at pre and post-intervention. Secondary outcomes: level of help needed, stages of MT-completion, independence, balance, fear of falling (FOF), MI ability. Data were collected four ti...

Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

Trials — Mon, 16 Jan 2012 05:00:00 +0100

Conclusions: We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm.Trial registration: ClinicalTrials.gov Identifier: NCT00821509Source of funding: The Finnish Work Environment Fund and the National Institute for Health and Welfare (Source: Trials)

Involvement of consumers in studies run by the Medical Research Council (MRC) Clinical Trials Unit: Results of a survey

Trials — Fri, 13 Jan 2012 05:00:00 +0100

Conclusions: Whilst most researchers identified benefits of involving consumers, most of the studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future research conducted within the MRC Clinical Trials Unit and beyond. (Source: Trials)

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE Trial): Study protocol for a randomized controlled trial.

Trials — Thu, 12 Jan 2012 05:00:00 +0100

DiscussionThe CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. (Source: Trials)

A GO intervention program for enhancing elementary school children's cognitive functions and control abilities of emotion and behavior: study protocol for a randomized controlled trial

Trials — Thu, 12 Jan 2012 05:00:00 +0100

DiscussionTo our knowledge, this study will be the first RCT to investigate the efficacy of a GO intervention program for elementary school children. If thisintervention is effective, we will be able to take the next steps in making an educational program to enhance children's executive function (EF) and other cognitive abilities using GO. In addition, we further will investigate the transfer effects of the GO intervention program through EF. We also will investigate neuroplasticity with the GO intervention using neuroimaging.Trial Registration: UMIN Clinical Trials Registry UMIN000006324 (Source: Trials)

Managing co-morbid depression and anxiety in primary care patients with asthma and/or Chronic Obstructive Pulmonary Disease: study protocol for a randomized controlled trial.

Trials — Wed, 11 Jan 2012 05:00:00 +0100

Discussion: The present study is a large primary care study on the treatment of co-morbid depression and anxiety in patients with asthma and COPD. Strengths of this study are its randomized design, the focus on implementation in primary care and the fact that it applies the latest findings on the treatment of depression and anxiety. First results are expected in 2012/2013. Trial registration: Dutch Trial Register NTR2626 (Source: Trials)

Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience

Trials — Sun, 08 Jan 2012 05:00:00 +0100

This study was aimed to assess how these different trial management strategies affected trial performance. Methods: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. Results: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p=0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p (Source: Trials)

A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a cluster randomized controlled trial

Trials — Fri, 06 Jan 2012 05:00:00 +0100

This study evaluates the effectiveness and cost-effectiveness of introducing two different provider training packages, alongside rapid diagnostic tests (RDTs), designed to equip providers with the knowledge and practical skills needed to effectively diagnose and treat febrile patients. The overall aim is to target antimalarial treatment better and to facilitate optimal use of malaria treatment guidelines. Methods: A 3-arm stratified, cluster randomized trial will be conducted to assess whether introducing RDTs with provider training (basic or enhanced) is more cost-effective than current practice without RDTs, and whether there is a difference in the cost effectiveness of the provider training interventions. The primary outcome is the proportion of patients attending facilities that report...

Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial

Trials — Thu, 05 Jan 2012 05:00:00 +0100

This study is a multi-centre, randomised, double-blind, controlled trial with two parallel arms: the group taking GJBNH and the group taking placebo. 100 patients (women from age 18 to 35) will be enrolled to the trial. Through randomization 50 patients will be in experiment arm, and the other 50 patients will be in control arm. At the second visit (baseline), all participants who were already screened that they fulfil both the inclusion and the exclusion criteria will be randomised into two groups. Each group will take the intervention three times per day during two menstrual cycles. After the treatment for two cycles, each patient will be followed up during their 3rd, 4th and 5th menstrual cycles. From the screening (Visit 1) through the second follow-up (Visit 6) the entire process will...

Clustering in surgical trials - database of intracluster correlations

Trials — Wed, 04 Jan 2012 05:00:00 +0100

Conclusions: This database provides trialists with valuable information on how to design surgical trials. Our data suggests clustering of outcome is more of an issue than has been previously acknowledged. We anticipate that over time the addition of ICCs from further surgical trial datasets to our database will further inform the design of surgical trials. (Source: Trials)

Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: Primary results of a randomized controlled trial (VIAMI-trial)

Trials — Tue, 03 Jan 2012 05:00:00 +0100

Background: Patients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA). Methods: Patients admitted with an (sub)acute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography) to an invasive or a ...

Transfusion of fresh frozen plasma in non-bleeding ICU patients -TOPIC TRIAL: study protocol for a randomized controlled trial

Trials — Fri, 23 Dec 2011 05:00:00 +0100

DiscussionThe Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure.Trial registration: Dutch Trial Register NTR2262 and www.clinicaltrials.gov NCT01143909 (Source: Trials)

Comparisons against baseline within randomised groups are often used and can be highly misleading

Trials — Thu, 22 Dec 2011 05:00:00 +0100

Conclusions: Randomised groups should be compared directly by two-sample methods and that separate tests against baseline are highly misleading. (Source: Trials)

A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial

Trials — Thu, 22 Dec 2011 05:00:00 +0100

DiscussionThis vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.Trial Registration: Clinicaltrials.gov NCT01070056 (Source: Trials)

Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - Study protocol of a randomised controlled trial

Trials — Wed, 21 Dec 2011 05:00:00 +0100

Background: Exercise programmes can be administered successfully as therapeutic agents to patients with a number of chronic diseases and help to improve physical functioning in older adults. Usually, such programmes target either healthy and mobile community-dwelling seniors or elderly individuals living in nursing institutions or special residences. Chronically ill or mobility-restricted individuals, however, are difficult to reach when they live in their own homes.A pilot study has shown good feasibility of a home-based exercise programme that is delivered to this target group through cooperation between general practitioners and exercise therapists. A logical next step involves evaluation of the effects of the programme.Methods/designThe study is designed as a randomised controlled tria...

Efficacy of Essential Oil Mouthwash with and without Alcohol: a 3-Day Plaque Accumulation Model

Trials — Thu, 15 Dec 2011 05:00:00 +0100

Conclusion: The essential oil containing mouthwash without alcohol seems to have a less inhibiting effect on the plaque regrowth than the traditional alcoholic solution.Trial Registration: ClinicalTrials.gov NCT01411618 (Source: Trials)

Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial

Trials — Wed, 14 Dec 2011 05:00:00 +0100

A pilot study of computerised cognitive behavioural therapy (CCBT) for treatment of depression in Multiple Sclerosis patients identifies challenges in participant recruitment. (Source: Trials)

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

Trials — Wed, 14 Dec 2011 05:00:00 +0100

The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods: The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Re...

The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer - The ASCOLT study: Study Protocol for a randomized controlled trial

Trials — Wed, 14 Dec 2011 05:00:00 +0100

This study will randomize eligible patients with Dukes C or high risk Dukes B colorectal cancer, after completion of surgery and standard adjuvant chemotherapy (+/- radiation therapy for rectal cancer patients) to 200mg Aspirin or Placebo for 3 years. Stratification factors include study centre, rectal or colon cancer stage, and type of adjuvant chemotherapy (exposed/ not exposed to oxaliplatin). After randomization, patient will be followed up with 3 monthly assessments whilst on study drug and for a total of 5 years. Patients with active peptic ulcer disease, bleeding diathesis or on treatment with aspirin or anti-platelet agents will be excluded from the study.DiscussionThis study aims to evaluate Aspirin's role as an adjuvant treatment in colorectal cancer. If indeed found to be bene...

A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials

Trials — Tue, 13 Dec 2011 05:00:00 +0100

Conclusions: The statistical framework presented has potential to identify eligible patients and assist in the simplification of eligibility criteria which might encourage greater participation in clinical trials evaluating surgical interventions. (Source: Trials)

EXTUBATE: A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial.

Trials — Fri, 09 Dec 2011 05:00:00 +0100

Background: Respiratory distress syndrome is a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with lung injury and the development of chronic lung disease of prematurity. Efforts are needed to reduce the duration of mechanical ventilation in favour of less invasive forms of respiratory support and to improve rates of successful extubation.Non-invasive respiratory support has been demonstrated to be less injurious to the premature lung. Standard practice is to use nasal continuous positive airway pressure (n-CPAP) following extubation to support the baby's breathing. Many clinicians also use nasal biphasic positive airway pressure (n-BiPAP) in efforts to improve rates of succe...

Reporting of participant flow diagrams in published reports of randomized trials

Trials — Mon, 05 Dec 2011 05:00:00 +0100

Conclusions: Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented. (Source: Trials)

Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFOs) in stroke: study protocol for a randomised controlled trial

Trials — Mon, 05 Dec 2011 05:00:00 +0100

DiscussionIn addition to answering the primary research question the broad range of measures that will be taken during this study are likely to contribute to a wider understanding of the impact of ankle-foot orthoses on the lives of stroke patients.KeywordsAnkle-foot orthosis, biomechanics, gait analysis, visualisation, stroke, hemiplegia, 3D motion analysisTrial registration: ISRCTN 52126764 (Source: Trials)

Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial

Trials — Mon, 05 Dec 2011 05:00:00 +0100

This study is registered at ClinicalTrials.gov: NCT01168479 (Source: Trials)

The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial

Trials — Mon, 05 Dec 2011 05:00:00 +0100

DiscussionThe ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors.Trial Registration: http://www.ClinicalTrials.gov. Identifier: NCT01185626Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743 (Source: Trials)

Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited

Trials — Wed, 30 Nov 2011 05:00:00 +0100

Conclusion: The data from the trial will: improve the external validity and prediction of the estimates of the overall treatment effects (efficacy and safety) of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and, provide the first large-scale randomised evidence on effects in patients over 80, an age group which had largely been excluded from previous acute stroke trials.Trial registration ISRCTN25765518 (Source: Trials)

The use of Carer Assisted Adherence Therapy for people with Parkinson's disease and their carers (CAAT-PARK): study protocol for a randomised controlled trial

Trials — Mon, 28 Nov 2011 05:00:00 +0100

Background: Pharmacological intervention is essential for managing the symptoms of Parkinson's disease. Adherence to medication regimens however is a major problem. Poor adherence leads to significant motor deterioration and inadequate symptom control. This results in poor quality of life. Whilst interventions to improve medication adherence have shown considerable benefit in other chronic conditions, the efficacy of such treatments in Parkinson's disease is less well researched. Many people with Parkinson's disease require substantial support from spouse/caregivers. This often extends to medication taking. Consequently, spouse/caregiver's support for timely medication management is paramount. We aim to investigate the benefit of a novel intervention, Carer Assisted Adherence Therapy, for ...

Five years of Trials

Trials — Wed, 23 Nov 2011 05:00:00 +0100

This editorial marks the launch of a special collection of articles highlighting 'Five years of Trials' (http://www.trialsjournal.com/series/5years). The journal's achievements on its objectives since 2006 are described and some of the challenges still ahead are outlined - in particular further innovating in the reporting of trials and the publication of negative results. The other articles in this series are examples of where Trials has demonstrated progress on its objectives. These include the publication of raw data, extended versions of previously published trial-related articles, descriptions of 'lessons learned', negative results, and educational articles regarding ethics and reporting bias. (Source: Trials)

Why we need easy access to all data from all clinical trials and how to accomplish it

Trials — Wed, 23 Nov 2011 05:00:00 +0100

International calls for registering all trials involving humans and for sharing the results, and sometimes also the raw data and the trial protocols, have increased in recent years. Such calls have come, for example, from the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), the US National Institutes of Heath, the US Congress, the European Commission, the European ombudsman, journal editors, The Cochrane Collaboration, and several funders, for example the UK Medical Research Council, the Wellcome Trust, the Bill and Melinda Gates Foundation and the Hewlett Foundation.Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an arti...

A comparison of specialist rehabilitation and care assistant support with specialist rehabilitation alone and usual care for people with Parkinson's living in the community: study protocol for a randomised controlled trial.

Trials — Wed, 23 Nov 2011 05:00:00 +0100

DiscussionThe trial investigates components of recent national policy recommendations for people with long term conditions, and Parkinson's Disease in particular, and will provide guidance to inform local service planning and commissioning.Trial registration: ISRCTN44577970 (Source: Trials)

The impact of dose of the angiotensin-receptor blocker valsartan on the post-myocardial infarction ventricular remodeling: study protocol for a randomized controlled trial

Trials — Tue, 22 Nov 2011 05:00:00 +0100

This study also aims to assess neurohormone change and clinical parameters of patients during the post-infarct period. A total of 1116 patients with left ventricular dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to a maximal tolerable dose (up to 320 mg/day) or usual dose (80 mg/day) of valsartan for 12 months in 2:1 ratio. Echocardiographic analysis for quantifying post-MI ventricular remodeling is to be conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times.DiscussionVALID is a multicenter collaborative study to evaluate the impact of dose of valsartan on the post-MI ventricular remodeling. The results of the study provide information about optimal dosing of the drug in the management...

A trial for the use of qigong in the treatment of pre and mild essential hypertension: a study protocol for a randomized controlled trial

Trials — Mon, 21 Nov 2011 05:00:00 +0100

This study will be the first randomized trial to investigate the effectiveness of qigong exercises for the treatment of pre- and mild hypertension. The results of this study will help to establish the optimal approach for the care of adults with pre- or mild hypertension. (Source: Trials)

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

Trials — Mon, 21 Nov 2011 05:00:00 +0100

DiscussionThe PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity.Trial Registration:The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390). (Source: Trials)

Everolimus and long acting octreotide as a volume reducing treatment of polycystic livers (ELATE): study protocol for a randomized controlled trial

Trials — Mon, 21 Nov 2011 05:00:00 +0100

In this study we present the structure of the trial and the characteristics of the included patients.Methods/designThis is a randomized open-label clinical trial comparing the effect of 12 months of everolimus and octreotide to octreotide monotherapy in PLD patients. Primary outcome is change in liver volume determined by CT-volumetry. Secondary outcomes are changes in abdominal symptoms and quality of life. Moreover, safety and tolerability of the drugs will be assessed.DiscussionThis trial will examine the relative efficacy of combination therapy with octreotide and everolimus to octreotide monotherapy. Since they apply to different pathways of cystogenesis we expect that combining octreotide and everolimus will result in a cumulative reduction of polycystic liver volume.Trial registrati...

Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) Trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial.

Trials — Fri, 18 Nov 2011 05:00:00 +0100

This study provides an interesting opportunity to address this gap in the literature. Methods: Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft fail...

Assessing the efficacy of the Healthy Eating and Lifestyle Programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial.

Trials — Wed, 16 Nov 2011 05:00:00 +0100

Background: The childhood obesity epidemic is one of the foremost UK health priorities. Childhood obesity tracks into adult life and places individuals at considerable risk for diabetes, cardiovascular disease, liver disease and other morbidities. There is widespread need for paediatric lifestyle programmes as change may be easier to accomplish in childhood than later in life.Study Design/MethodThe study will evaluate the management of adolescent obesity by conducting a Medical Research Council complex intervention phase III efficacy randomised clinical trial of the Healthy Eating Lifestyle Programme within primary care. The study tests a community delivered multi-component intervention designed for adolescents developed from best practice as identified by National Institute for Health and...

Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: Study protocol for a randomized controlled trial.

Trials — Tue, 15 Nov 2011 05:00:00 +0100

DiscussionThe results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. (Source: Trials)

Randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results

Trials — Tue, 08 Nov 2011 05:00:00 +0100

Background: Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation.ObjectiveTo evaluate the efficacy of the early administration of selected probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate-degree infection to prevent spontaneous premature delivery and associated neonatal morbidity. Methods: Asymptomatic pregnant women at less than 20 weeks of gestation, with no indication of elective preterm delivery, with a vaginal pH [greater than or equal to] 4.5 and Nugent score > 3 were randomly assigned to the placebo or intervention group (oral administration of selected lactobacilli up to the 24th to 26th week of gestation). The randomisation was stratified for the history of premature delivery (HPD) and blocked. The...

Effect of additional treatment with EXenatide in patients with an acute myocardial infarction (EXAMI): study protocol for a randomized controlled trial

Trials — Tue, 08 Nov 2011 05:00:00 +0100

DiscussionIf the current study demonstrates cardioprotective effects, exenatide may constitute a novel therapeutic option to reduce infarct size and preserve cardiac function in adjunction to reperfusion therapy in patients with acute myocardial infarction.Trial registration: www.clinicaltrials.gov; unique identifier NCT01254123 (Source: Trials)

The efficacy of a brief intervention in reducing hazardous drinking in working age men in Russia: the HIM (Health for Izhevsk men) individually randomised parallel group exploratory trial

Trials — Fri, 04 Nov 2011 04:00:00 +0100

A trial of counselling sessions involving health checks as a means to reduce harm associated with dangerous drinking among Russian working men was found to be feasible in 441 patients but no difference was found between the intervention and control groups. (Source: Trials)

The impact of clinical data on the evaluation of tibial fracture healing

Trials — Thu, 03 Nov 2011 04:00:00 +0100

The addition of clinical information to radiographic data when assessing fracture healing was found to change the outcome decision in 19 out of 47 patients, in a substudy of a tibial fracture treatment trial. (Source: Trials)

An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial

Trials — Tue, 01 Nov 2011 04:00:00 +0100

DiscussionThe question is not merely to develop an efficacious package but also to identify and test delivery strategies that enable scaling up, which requires effectiveness studies in a health systems context, adapting and testing Asian community-based studies in various African contexts.Trial registration number: ISRCTN41046462 (Source: Trials)

Outcomes of Usual Chiropractic, Harm & efficacy, the OUCH study: study protocol for a randomized controlled trial.

Trials — Mon, 31 Oct 2011 04:00:00 +0100

Background: Previous studies have demonstrated that adverse events occur during chiropractic. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods: One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pa...

Oxygen persufflation as adjunct in liver preservation (OPAL): Study protocol for a randomized controlled trial

Trials — Fri, 28 Oct 2011 04:00:00 +0100

Background: Early graft dysfunction due to preservation/reperfusion injury represents a dramatic event after liver transplantation. Enhancement of donor organ criteria, in order to cope with the ever increasing donor shortage, further increases graft susceptibility to ischemic alterations. Major parts of post-preservation injury, however, occur at the time of warm reperfusion but not during ischemic storage; successful reperfusion of ischemic tissue in turn depends on an adequate redox and intracellular signal homeostasis. The latter has been shown experimentally to be favorably influenced by oxygen persuffaltion within short time spans. Thus viability of marginally preserved liver grafts could still be augmented by transient hypothermic reconditioning even after normal procurement and sta...

Investigating a training supporting shared decision making (IT'S SDM 2011): study protocol for a randomized controlled trial

Trials — Wed, 26 Oct 2011 04:00:00 +0100

This study will 1) evaluate a new physicians' communication training regarding patient involvement in terms of SDM, 2) validate SDM-MASS, a new compound measure of SDM, and 3) evaluate the effects of SDM on the perceived quality of the decision process and on the elaboration of the decision.MethodIn a multi-center randomized controlled trial with a waiting control group, 40 physicians from 7 medical fields are enrolled. Each physician contributes a sequence of four medical consultations including a diagnostic or treatment decision.The intervention consists of two condensed video-based individual coaching sessions (15min.) supported by a manual and a DVD. The interventions alternate with three measurement points plus follow up (6 months).Realized patient involvement is measured using the co...

Collaborative research between academia and industry using a large clinical trial database: A case study in Alzheimer's disease

Trials — Wed, 26 Oct 2011 04:00:00 +0100

Collaboration between industry and academia fully utilises the donepezil database in furthering understanding of Alzheimer?s Disease, demonstrating the benefits of large clinical trials repositories in advancing medical research and scientific knowledge. (Source: Trials)

Alzheimer's Disease - Input of vitamin D with mEmantine Assay (AD-IDEA Trial): study protocol for a randomized controlled trial

Trials — Thu, 20 Oct 2011 04:00:00 +0100

Background: Current treatments for Alzheimer's disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline. The aim of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive performance in patients suffering from moderate ADRD and receiving memantine. Methods: The AD-IDEA Trial is a unicentre, double-blind, randomized, placebo-controlled, intent-to...

Effectiveness of Technology-Assisted Case Management in Low Income Adults with Type 2 Diabetes (TACM-DM): Study Protocol for a Randomized Controlled Trial

Trials — Thu, 20 Oct 2011 04:00:00 +0100

Background: An estimated 1 in 3 American adults will have diabetes by the year 2050. Nationally, South Carolina ranks 10th in cases of diagnosed diabetes compared to other states. In adults, type 2 diabetes (T2DM) accounts for approximately 90-95% of all diagnosed cases of diabetes. Clinically, provider and health system factors account for (Source: Trials)

Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

Trials — Mon, 17 Oct 2011 04:00:00 +0100

This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s) that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such patients. Thus, we aim to contribute a well-designed trial, relevant to all clinicians involved in the care for donor site wounds, which will help enhance uniformity and quality of care for these patients.Trial registration: www.trialregister.nl, NTR1849. Date registered: June 9, 2009 (Source: Trials)

Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol of a randomized controlled trial

Trials — Fri, 14 Oct 2011 04:00:00 +0100

DiscussionThe TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients.Trial registration number: http://www.ClinicalTrials.gov NCT01347528. (Source: Trials)

Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial : study protocol for a randomized controlled trial

Trials — Fri, 14 Oct 2011 04:00:00 +0100

Discussion The CORTI-TC trial is the first randomized controlled trial powered to investigate whether hydrocortisone with fludrocortisone in TBI patients with CI prevent HAP and improve long term recovery.Trial registration NCT01093261Funding This work is supported by a grant from the Societe Francaise d'Anesthesie Reanimation (SFAR) (Source: Trials)

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

Trials — Thu, 13 Oct 2011 04:00:00 +0100

DiscussionThe 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. (Source: Trials)

The Chronic Care for age-related macular degeneration study (CHARMED): Study protocol for a randomized controlled trial

Trials — Tue, 11 Oct 2011 04:00:00 +0100

This study will be the first to assess this approach in neovascular age-related macular degeneration. If our hypothesis will be confirmed, the implementation of this approach in routine care for patients with with neovascular age-related macular degeneration should be considered.Trial RegistrationCurrent controlled trials ISRCTN32507927. (Source: Trials)

Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial

Trials — Tue, 11 Oct 2011 04:00:00 +0100

Background: Severe gait disturbances in idiopathic Parkinson's disease (PD) are observed in up to 80% of all patients in advanced disease stages with important impact on quality of life. There is an unmet need for further symptomatic therapeutic strategies, particularly as gait disturbances generally respond unfavourably to dopaminergic medication and conventional deep brain stimulation of the subthalamic nucleus in advanced disease stages. Recent pathophysiological research pointed to nigro-pontine networks entrained to locomotor integration. Stimulation of the pedunculopontine nucleus (PPN) is currently under investigation, however, hitherto remains controversial. The substantia nigra pars reticulata (SNr) - entrained into integrative locomotor networks - is pathologically overactive in ...

The effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur fracture - The CAESAR study: study protocol for a randomized controlled trial

Trials — Tue, 11 Oct 2011 04:00:00 +0100

Conclusion: This study intents to identify C1-esterase inhibitor as a safe and potent anti-inflammatory agent, that is capable of suppressing systemic inflammation in trauma patients. This might facilitate early total care procedures by lowering the risk of inflammation in response to the surgical intervention. This could result in increased functional outcomes and reduced health care related costs.Trial registration:clinicaltrials.gov NCT01275976 (January 12th 2011) (Source: Trials)

Reconciling Research and Implementation in Micro Health Insurance Experiments in India: Study Protocol for a Randomized Controlled Trial

Trials — Tue, 11 Oct 2011 04:00:00 +0100

DiscussionWhen a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.KeywordsMicro insurance, community based, healthcare utilisation, financial protection, randomised trial (Source: Trials)

A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial

Trials — Tue, 11 Oct 2011 04:00:00 +0100

Background: Depression accounts for the greatest burden of disease among all mental health problems, and is expected to become the second-highest amongst all general health problems by 2020. By the age of 75, 1 in 7 older people meet formal diagnostic criteria for depression. Efforts to ameliorate the burden of illness and personal suffering associated with depression in older people have focussed on those with more severe depressive syndromes. Less attention has been paid to those with mild disorders/sub-threshold depressive syndromes but these patients also suffer impairments in their quality of life and level of functioning. Methods: The CASPER study has been designed to assemble an epidemiological cohort of people over 75 years of age (the CASPER cohort), from which we will identify th...

Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians)

Trials — Thu, 06 Oct 2011 04:00:00 +0100

Conclusions: The PODOSA experience shows that a community orientated, personal approach for recruiting South Asian ethnic minority populations can be successful in a trial setting. We recommend that consideration is given to cover recruitment costs associated with community engagement and other personalised approaches. Researchers should consider prioritising approaches that minimise interference with professionals' work and, particularly in the current economic climate, keep costs to a minimum. The lessons learned in PODOSA should contribute to future community based trials in South Asians. (Source: Trials)

Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial

Trials — Thu, 06 Oct 2011 04:00:00 +0100

DiscussionThe present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS. (Source: Trials)

Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis

Trials — Wed, 05 Oct 2011 04:00:00 +0100

This study will establish the effectiveness of a new model of multi-professional clinical medication reviews in care homes, using novel approaches to recruitment and consent. It is the first study to undertake an examination of direct patient outcomes, together with an economic analysis.Trial RegistrationCurrent Controlled Trials ISRCTN90761620. (Source: Trials)

Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH System) in nonspecific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial.

Trials — Tue, 04 Oct 2011 04:00:00 +0100

DiscussionCompared to other medical specialties, physical and rehabilitation medicine (PRM) has not yet received the deserved recognition from clinicians and researchers in the scientific community, especially for medical devices. The best way to change this disadvantage is through well-conducted clinical research in sham-controlled randomized trials. Sham treatment groups are essential for improving the level of evidence-based practice in PRM. The present trial will counter the general lack of evidence concerning medical devices used in LBP therapy. (Source: Trials)

Reduction Of Surgical Site Infection using a Novel Intervention (ROSSINI): study protocol for a randomised controlled trial

Trials — Tue, 04 Oct 2011 04:00:00 +0100

DiscussionRossini is the first multicentre observer-blinded randomised controlled trial of sufficient size and quality to establish whether the use of a wound-edge protection device in adult patients undergoing abdominal surgery leads to a lower rate of SSI. The results of this study will be used to inform current surgical practice and may potentially benefit patients undergoing surgery in the future.Trial registrationCurrent Controlled Trials ISRCTN40402832 (Source: Trials)

Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial

Trials — Fri, 30 Sep 2011 04:00:00 +0100

Background: Late onset neonatal sepsis (LOS) with the mortality of 17 to 27% is still a serious disease. Meropenem is an antibiotic with wide antibacterial coverage. The advantage of it over standard of care could be its wider antibacterial coverage and thus the use of mono- instead of combination therapy. Methods: NeoMero1, an open label, randomised, comparator controlled, superiority trial aims to compare the efficacy of meropenem with a predefined standard of care (ampicillin plus gentamicin or cefotaxime plus gentamicin) in the treatment of LOS in neonates and infants aged less than 90 days admitted to a neonatal intensive care unit.A total of 550 subjects will be recruited following a 1:1 randomisation scheme. The trial includes patients with culture confirmed (at least one positive c...

The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: Neck of femur optimisation therapy - targeted stroke volume (NOTTS) : study protocol for a randomized controlled trial.

Trials — Wed, 28 Sep 2011 04:00:00 +0100

Background: Approximately 70,000 patients / year undergo surgery for repair of a fractured hip in the United Kingdom. This is associated with 30-day mortality of 9% and survivors have a considerable length of acute hospital stay postoperatively (median 26 days). Use of oesophageal Doppler monitoring to guide intra-operative fluid administration in hip fracture repair has previously been associated with a reduction in hospital stay of 4-5 days. Most hip fracture surgery is now performed under spinal anaesthesia. Oesophageal Doppler monitoring may be unreliable in the presence of spinal anaesthesia and most patients would not tolerate the probes. An alternative method of guiding fluid administration (minimally-invasive arterial pulse contour analysis) has been shown to reduce length of stay ...

Failure to report protocol violations in clinical trials: A threat to internal validity?

Trials — Wed, 28 Sep 2011 04:00:00 +0100

Conclusions: PVs are under-reported. Although the CONSORT statement provides guidance on the reporting of PVs, reporting requirements are not explicit for all types of PVs. As a first step towards improved reporting by authors, we recommend the CONSORT statement highlight the importance of PVs by making reporting requirements more explicit. (Source: Trials)

The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial.

Trials — Mon, 26 Sep 2011 04:00:00 +0100

Background: Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal ...

DIABRISK - SL Prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's -study protocol for a randomized controlled trial

Trials — Mon, 26 Sep 2011 04:00:00 +0100

DiscussionDIABRISK-SL is a large population based trial to evaluate the prevalence of diabetes, pre-diabetes and cardio-metabolic risk factors among young urban Sri-Lankans and the effect of a primary prevention strategy on cardio-metabolic disease end points. This work will enable country specific and regional cardio-metabolic risk scores to be derived. Further if the proposed intervention is successful the results of this study can be translated and implemented as a low-cost primary prevention tool in Sri-Lanka and other low/middle income developing countries.Trial registration: The trial is registered with the World Health Organisation and Sri-Lanka clinical trial registry number SLCTR/2008/003 (Source: Trials)

Self Management Activation Randomised Trial for Prostatitis - (SMART-P): study protocol for a randomised controlled trial

Trials — Mon, 26 Sep 2011 04:00:00 +0100

DISCUSSIONIf this group administered self management programme is shown to be effective in the treatment of men with chronic prostatitis it may become the new standard of care for these patients. Furthermore, it may be adapted for use in women with interstitial cystitis, a condition which is analogous to chronic prostatitis in men. (Source: Trials)

Efficacy of electroacupuncture at Zhongliao point (BL33) for mild and moderate benign prostatic hyperplasia: study protocol for a randomized controlled trial

Trials — Mon, 26 Sep 2011 04:00:00 +0100

DiscussionThis trial will assess the specific therapeutic effect of electroacupuncture at BL33 for mild and moderate BPH.Trial registrationProtocol Registration System of Clinical Trials.gov NCT01218243 (Source: Trials)

Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

Trials — Mon, 26 Sep 2011 04:00:00 +0100

Background: ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods: The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query) and "dirty" (any incomplete, inconsistent or illegible data). The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent) and time delay (in days) between visit and receipt of correct data. ...

Transfusion of Red Cells in Hematopoietic Stem Cell Transplantation (TRIST): Study protocol for a randomized controlled trial

Trials — Wed, 21 Sep 2011 04:00:00 +0100

Conclusion: Upon completion, this pilot trial will provide meaningful insight into red cell transfusion practice and its influence in hematopoietic stem cell transplant outcomes. Specifically, it will determine the relative benefits of a restrictive or liberal red cell transfusion strategy. Finally, the results of this trial inform the conduct of a larger study. (Source: Trials)

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

Trials — Mon, 19 Sep 2011 04:00:00 +0100

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 b...

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

Trials — Thu, 15 Sep 2011 04:00:00 +0100

DiscussionThe methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches.Trial Registration: ISRCTN37956201 (Source: Trials)

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

Trials — Wed, 14 Sep 2011 04:00:00 +0100

DiscussionHere, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drain improves clinical outcome after aneurysmal subarachnoid hemorrhage.Trial registration: www.clinicaltrials.gov Identifier: NCT01258257 (Source: Trials)

Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction

Trials — Wed, 14 Sep 2011 04:00:00 +0100

Cardiac magnetic resonance (CMR) offers a variety of parameters potentially suited as surrogate endpoints in clinical trials of acute myocardial infarction such as infarct size, myocardial salvage, microvascular obstruction or left ventricular volumes and ejection fraction. The present article reviews each of these parameters with regard to the pathophysiological basis, practical aspects, validity, reliability and its relative value (strengths and limitations) as compared to competitive modalities. Randomized controlled trials of acute myocardial infarction which have used CMR parameters as a primary endpoint are presented. (Source: Trials)

When is informed consent required in cluster randomized trials in health research?

Trials — Fri, 09 Sep 2011 04:00:00 +0100

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How ...

Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

Trials — Wed, 24 Aug 2011 23:00:00 +0100

Conclusion: Large between-centre differences in outcome do not necessarily affect the estimated treatment effect in RCTs, in contrast to current beliefs in the clinical area of TBI. (Source: Trials)

Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial

Trials — Tue, 23 Aug 2011 23:00:00 +0100

DiscussionPEPS therapy has potential as an economical, accessible, and acceptable intervention for people with personality disorder. The results from this randomised controlled trial will tell us if PEPS therapy is effective and cost-effective. If so, then it will be a useful treatment for inclusion in a broader menu of treatment options for this group of service users.Trial RegistrationInternational Standard Randomised Controlled Trial Number - ISRCTN70660936 (Source: Trials)

Simultaneous use of traditional Chinese medicine (Si-Ni-Tang) to treat septic shock patients: study protocol for a randomized controlled trial

Trials — Tue, 23 Aug 2011 23:00:00 +0100

DiscussionSi-Ni-Tang is composed of processed Zingiber officinale, Glycyrrhiza uralensis, and Aconitum carmichaeli. Zingiber officinale and Glycyrrhiza uralensis are found to have the ability to reduce pro-inflammatory cytokine production, to inhibit lipopolisaccharide-induced macrophage activation and function, and to lessen the bacterial load and suppress acute and chronic inflammation. Aconitum carmichaeli is known to have vasopressor activity, and positive chronotropic and inotropic effects. As this remedy has a potential benefit in treating septic shock patients, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later.Trial RegistrationWe have registered our study with ClinicalTrials.gov, a registry website for c...

Acute medical unit comprehensive geriatric assessment intervention study (AMIGOS): study protocol for a randomised controlled trial

Trials — Tue, 23 Aug 2011 23:00:00 +0100

Background: Many older people presenting to Acute Medical Units (AMU) are discharged after only a short stay (< 72 hours), yet many re-present to hospital or die within 1 year. Comprehensive Geriatric Assessment may improve patient outcomes for this group.MethodParticipantsPatients aged >70 years and scoring positive on a risk screening tool ('Identification of Seniors At Risk') who are discharged within 72 hours of attending an AMU with a medical crisis, recruited prior to discharge. Sample size is 400. Carers of participants will also be recruited.InterventionAssessment on the AMU and further out-patient management by a specialist physician in geriatric medicine. Assessment and further management will follow the principles of Comprehensive Geriatric Assessment, providing advice and suppo...

Effectiveness of an online group course for adolescents and young adults with depressive symptoms: study protocol for a randomized controlled trial

Trials — Thu, 18 Aug 2011 23:00:00 +0100

DiscussionThe trial should add to the body of knowledge on the effectiveness of Internet-based interventions for depression. To our knowledge, this will be the first RCT on an online group intervention in this field.Trial registration: NTR1694 (Source: Trials)

Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

Trials — Thu, 18 Aug 2011 23:00:00 +0100

Conclusions: The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery.Trial registration: Current Controlled Trials ISRCTN82127540 (Source: Trials)

Illness management and recovery (IMR) in Danish community mental health centres

Trials — Tue, 16 Aug 2011 23:00:00 +0100

DiscussionIf the results of this trial show IMR to be effective these positive results will strengthen the evidence of IMR as an effective comprehensive psychosocial intervention with a recovery-oriented approach for people with severe mental illness. This will have significant implications for the treatment and recovery of people with severe mental illness.Trial registration: Registration number NCT01361698. (Source: Trials)

Correction: The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

Trials — Mon, 15 Aug 2011 23:00:00 +0100