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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials
BackgroundRecruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare...
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Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol
BackgroundInfluenza and COVID-19 infections during pregnancy may have serious adverse consequences for women as well as their infants. However,...
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Psychosocial determinants for adherence to a healthy lifestyle and intervention participation in the FINGER trial: an exploratory analysis of a randomised clinical trial
Background and aimsPsychosocial factors may affect adherence to lifestyle interventions and lifestyle changes. The role of psychosocial factors in...
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Injury Prevention Programmes Fail to Change Most Lower Limb Kinematics and Kinetics in Female Team Field and Court Sports: A Systematic Review and Meta-Analysis of Randomised Controlled Trials
BackgroundOne mechanism by which exercise interventions may be effective in reducing anterior cruciate ligament (ACL) injury risk is through changes...
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Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial
BackgroundVertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their...
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Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
BackgroundClinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial....
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What influences communication about retention in randomised trials: a multi-trial, theory-based analysis exploring trial staff perspectives
BackgroundRetention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on...
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Systematic review of the characteristics of school-based feasibility cluster randomised trials of interventions for improving the health of pupils in the UK
BackgroundThe last 20 years have seen a marked increase in the use of cluster randomised trials (CRTs) in schools to evaluate interventions for...
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Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study
BackgroundThe LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal...
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Statistical analysis plans for two randomised controlled trials of the Narrative Experiences Online (NEON) Intervention: impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O)
BackgroundMental health recovery narratives are a first-hand account of an individual’s recovery from mental health distress, access to narratives...
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Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial
BackgroundStroke is the leading cause of acquired disability in France. While 90% of patients recover the ability to walk, it is often limited with a...
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Recruitment rates and strategies in exercise trials in cancer survivorship: a systematic review
PurposeDespite clear evidence-based supporting a benefit to exercise on physical and psychological metrics in patients with cancer, recruitment to...
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Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya
BackgroundSelf-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring...
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Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs
BackgroundRandomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial...
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Re-evaluating the placebo response in recent canine dietary epilepsy trials
The placebo response is a common phenomenon. Limited evidence is available about its magnitude in canine epilepsy trials, even though it can...
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Effectiveness of mobile apps to improve urinary incontinence: a systematic review of randomised controlled trials
IntroductionPelvic floor exercises are effective in the treatment of urinary incontinence (UI) and are routinely prescribed, along with bladder...
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Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design
BackgroundNon-alcoholic steatohepatitis (NASH) is a liver disease currently lacking an approved therapy, resulting in significant clinical demand....
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The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program
BackgroundIncreasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of...
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Interventions to improve medicines optimisation in frail older patients in secondary and acute care settings: a systematic review of randomised controlled trials and non-randomised studies
Background : Frailty is a geriatric syndrome in which physiological systems have decreased reserve and resistance against stressors. Frailty is...
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Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression
Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to...