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Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting
BackgroundExternal randomised pilot trials aim to assess whether a future definitive Randomised Controlled Trial (RCT) is feasible. Prespecified...
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Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial
BackgroundDuring transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The...
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The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial—Study Design and Protocol
IntroductionMultiple daily injection insulin regimen (MDI) represents the most intensive insulin regimen used in the management of people with type 2...
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Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial
BackgroundVasovagal reactions (VVRs) are the most common acute complications of blood donation. Responsible for substantial morbidity, they also...
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NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial
IntroductionUsing pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or...
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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...
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Effect of lifestyle or metformin interventions before IVF/ICSI treatment on infertile women with overweight/obese and insulin resistance: a factorial design randomised controlled pilot trial
BackgroundFor infertile women with overweight/obesity and insulin resistance (IR), it is uncertain whether intervention before infertility treatment...
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The effects of etidronate on brain calcifications in Fahr’s disease or syndrome: rationale and design of the randomised, placebo-controlled, double-blind CALCIFADE trial
BackgroundFahr’s disease and syndrome are rare disorders leading to calcification of the small arteries in the basal ganglia of the brain, resulting...
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Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
BackgroundEvidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to...
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Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications
BackgroundExternal randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if...
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Medicinal Cannabis (MedCan 3): a randomised, multicentre, double-blind, placebo-controlled trial to assess THC/CBD (1:20) to relieve symptom burden in patients with cancer—a study protocol for a randomised controlled trial
BackgroundDistressing symptoms are common in advanced cancer. Medicinal cannabinoids are commonly prescribed for a variety of symptoms. There is...
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The SEE-IT Trial: emergency medical services Streaming Enabled Evaluation In Trauma: a feasibility randomised controlled trial
BackgroundUse of bystander video livestreaming from scene to Emergency Medical Services (EMS) is becoming increasingly common to aid decision making...
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Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial
BackgroundThe primary treatment of ulcerative colitis (UC) is medical therapy using a standard step-up approach. An appendectomy might modulate the...
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A participatory ergonomics intervention to re-design work and improve the musculoskeletal health of paramedics: protocol for a cluster randomised controlled trial
BackgroundIn this paper, we present the protocol for a cluster randomised controlled trial to evaluate the effectiveness and implementation of a...
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Efficacy of heel lifts for mid-portion Achilles tendinopathy (the LIFT trial): study protocol for a randomised controlled trial
BackgroundMid-portion Achilles tendinopathy is a common condition, characterised by localised Achilles tendon load-related pain and dysfunction....
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Randomised pilot and feasibility trial of a group intervention for men who perpetrate intimate partner violence against women
BackgroundThere is a need for robust evidence on the effectiveness and cost-effectiveness of domestic abuse perpetrator programmes in reducing...
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Personalised versus standard text message prompts for increasing trial participant response to telephone follow-up: an embedded randomised controlled retention trial
BackgroundImproving retention within randomised controlled trials is important. The effectiveness of different strategies can be assessed using a...
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The detection and management of attempted fraud during an online randomised trial
BackgroundOnline studies offer an efficient method of recruiting participants and collecting data. Whilst delivering an online randomised trial, we...
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Nonsurgical management of hallux valgus: findings of a randomised pilot and feasibility trial
BackgroundHallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of...
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Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents
BackgroundAdolescence is a period of heightened vulnerability to develo** mental health problems, and rates of mental health disorder in this age...
