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How do trial teams plan for retention during the design stage of the trial? A sco** review
BackgroundRetention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to...
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Identifying blood biomarkers for type 2 diabetes subty**: a report from the ORIGIN trial
Aims/hypothesisIndividuals with diabetes can be clustered into five subtypes using up to six routinely measured clinical variables. We hypothesised...
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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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Health Service Utilisation of People Living with Psychosis: Validity of Self-report Compared with Administrative Data in a Randomised Controlled Trial
BackgroundSelf-reported service use informs resource utilisation and cost estimates, though its validity for use within economic evaluations is...
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Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at police custody: a randomised controlled trial
BackgroundWithin England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams...
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Hyperbaric oxygen therapy for long COVID (HOT-LoCO), an interim safety report from a randomised controlled trial
BackgroundWith ~ 50 million individuals suffering from post-COVID condition (PCC), low health related quality of life (HRQoL) is a vast problem....
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Flexible bronchoscopy insufflated and high-flow nasal oxygen pilot trial (BUFFALO protocol pilot trial)
BackgroundHypoxaemia occurs in approximately 30% of children during anaesthesia for flexible bronchoscopy. High-flow nasal oxygen (HFNO) can prolong...
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Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites
BackgroundDesign and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons,...
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Develo** principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey
BackgroundThe way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and...
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Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol
BackgroundPeritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability...
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A report on parent involvement in planning a randomised controlled trial in neonatology and lactation – insights for current and future research
BackgroundPatient and Public Involvement (PPI) is a rich and valuable part of the process of planning, designing, carrying out and disseminating...
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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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Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy
BackgroundHypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is...
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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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The Hans Kai trial: study protocol of a mixed methods randomized controlled trial evaluating a peer-led health promotion program for adults with or without noncommunicable diseases
BackgroundA significant proportion of Canadian adults is impacted by chronic noncommunicable diseases. These conditions may be improved by peer-led...
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Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective
BackgroundIn early 2021, the Department of Health and Social Care in the UK called for research on the safety and immunogenicity of concomitant...
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Exploring implementation outcomes in the clinical trial context: a qualitative study of physician trial stakeholders
IntroductionCancer clinical trials can be considered evidence-based interventions with substantial benefits, but suffer from poor implementation...
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To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)
BackgroundRotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead...
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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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Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods
BackgroundPreventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not...