Trials

http://www.trialsjournal.com/

List of Papers (Total 4,046)

Risk of selection bias in randomized trials: further insight

The quality of randomization is an under-appreciated facet of trial design. The present piece represents an advance in our collective understanding of how allocation concealment and randomization relate to risk of selection bias in randomized trials, and other measures are also considered. Though the overwhelming majority of the advice given is timely and correct, it is more ...

Assessment of clinical trial participant patient satisfaction: a call to action

Background As patient satisfaction scores become increasingly relevant in today’s health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. Methods We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to ...

A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris

Background Psoriasis vulgaris (PV) has been causing increasing concern due to its highly prevalent, harmful and therapy-resistant characteristics. The YXBCM01 (Chinese herbal medicine) for PV trial evaluates the effects of YXBCM01 on relapse rate in patients suffering from PV. As an update to the published design and method for the trial, this paper presents the statistical plan ...

Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial

Background Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as ...

Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial

Background Collaborative Assessment and Management of Suicidality (CAMS) is a therapeutic framework that appears promising to reduce suicidal ideation and suicidal cognition. CAMS has not previously been evaluated in a standard specialized mental health care setting for patients with suicidal problems in general. In this pragmatic randomized controlled trial (RCT) we will ...

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial

Background Real-time functional magnetic resonance imaging (rtfMRI) is used for neurofeedback training (NFT). Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT for relapse prevention in alcohol dependence. Methods/design Participants are alcohol-dependent patients who have completed a detoxification programme within the past ...

Realist trials and the testing of context-mechanism-outcome configurations: a response to Van Belle et al.

Background Van Belle et al. argue that our attempt to pursue realist evaluation via a randomised trial will be fruitless because we misunderstand realist ontology (confusing intervention mechanisms with intervention activities and with statistical mediation analyses) and because RCTs cannot comprehensively examine how and why outcome patterns are caused by mechanisms triggered in ...

Deep brain stimulation of the posterior subthalamic area and the thalamus in patients with essential tremor: study protocol for a randomized controlled pilot trial

Background Deep brain stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus is effective in medication refractory essential tremor (ET). In recent years, evidence has accumulated that the region ventral to the VIM, the posterior subthalamic area (PSA), might be an equally or even more effective target for electrode implantation. However, this evidence is ...

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial

Background Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring ...

STEPWISE – STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial

Background People with schizophrenia are two to three times more likely to be overweight than the general population. The UK National Institute of Health and Care Excellence (NICE) recommends an annual physical health review with signposting to, or provision of, a lifestyle programme to address weight concerns and obesity. The purpose of this randomised controlled trial is to ...

Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis

Background Citation bias occurs when positive trials involving a medical intervention receive more citations than neutral or negative trials of similar quality. Several large clinical trials have studied the use of thrombolytic agents for the treatment of acute ischemic stroke with differing results, thereby presenting an opportunity to assess these trials for evidence of citation ...

Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial

Background GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) and 1,4-butanediol (1,4-BD) are central nervous system depressants whose street names include ‘G’ and ‘liquid ecstasy’. They are used recreationally predominately for their stimulant and pro-sexual effects or for sedation to help with sleep and/or to ‘come down’ after using stimulant recreational ...

Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial

Background Postoperative pain and, in a more extended perspective, quality of recovery (QOR) should be considered the principal endpoints after day surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are a cornerstone of pain treatment after painful day surgery. Nevertheless, NSAIDs are not always sufficiently effective, have numerous contraindications, and ...

Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial

Background A large proportion of patients with T2DM in China do not meet accepted HbA1c targets despite the availability of guidelines that describe a treatment pathway for achieving glycemic control. The aim of this study is to identify the fasting plasma glucose (FPG) target that will provide the highest control rate of HbA1c <7 % in Chinese patients with T2DM treated with an ...

The ABBA study – approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial

Background The core symptoms of bulimia nervosa (BN) and binge eating disorder (BED) are recurrent episodes of binge eating. Despite negative psychological and physical consequences, BN/BED patients show uncontrollable approach tendencies towards food. This cognitive bias occurs at an early stage of information processing. Cognitive bias modification (CBM) directly targets such ...

How to design clinical rehabilitation trials for the upper paretic limb early post stroke?

Background The impact of spontaneous neurobiological recovery is still neglected in designing rehabilitation trials early post stroke. We aimed to investigate the impact of the timing of randomization and prognostic stratification on the required sample sizes that are needed to reveal significant intervention effects on upper limb function at 26 weeks after first-ever ischemic ...

Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial

Background Recurrent nightmares can effectively be treated with cognitive-behavioral techniques such as imagery rehearsal therapy, which involves imagery rescripting (IR) of nightmares, and imaginal exposure (IE) therapy. However, the underlying mechanisms of these treatments remain largely unknown. To investigate this, we identified a number of variables that might mediate the ...

Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial

Background Recruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates ...

Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

Background Whether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible ...

Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery

Background The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet little is known about the role and influence of different stakeholders’ views during COS development. We report an exploratory case study examining how stakeholder ...

Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial

Background Telephone consultations in general practice are on the increase. However, data on their efficiency in terms of out-of-hours general practitioner (GP) workload, visits to hospital emergency departments (ED), cost, patient safety and satisfaction are relatively scant. The aim of this trial is to assess the effectiveness of telephone consultations provided by French ...

A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial

Background Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) frequently coexist, significantly reducing patients’ quality of life and increasing morbidity and mortality. For either single disease, a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced ...

A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial

Background Family members, who provide the majority of care for persons with dementia, are especially vulnerable to developing depression. Interventions targeting their depressive symptoms have been proposed but their efficacies vary considerably. It has been suggested that interventions carried out in the home setting and involving both caregivers and care recipients are more ...