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  1. How do trial teams plan for retention during the design stage of the trial? A sco** review

    Background

    Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to...

    Ellen Murphy, Katie Gillies, Frances Shiely in Trials
    Article Open access 04 December 2023
  2. Identifying blood biomarkers for type 2 diabetes subty**: a report from the ORIGIN trial

    Aims/hypothesis

    Individuals with diabetes can be clustered into five subtypes using up to six routinely measured clinical variables. We hypothesised...

    Marie Pigeyre, Hertzel Gerstein, ... Guillaume Paré in Diabetologia
    Article 01 March 2023
  3. Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications

    Background

    External randomised pilot trials aim to determine whether a future definitive randomised controlled trial (RCT) should be conducted, and if...

    Katie Mellor, Susan J. Dutton, Sally Hopewell in Trials
    Article Open access 24 January 2023
  4. Health Service Utilisation of People Living with Psychosis: Validity of Self-report Compared with Administrative Data in a Randomised Controlled Trial

    Background

    Self-reported service use informs resource utilisation and cost estimates, though its validity for use within economic evaluations is...

    Vergil Dolar, Mary Lou Chatterton, ... Lidia Engel in Applied Health Economics and Health Policy
    Article 21 November 2023
  5. Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at police custody: a randomised controlled trial

    Background

    Within England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams...

    Gwenllian Moody, Elinor Coulman, ... Samantha Flynn in Trials
    Article Open access 02 March 2024
  6. Hyperbaric oxygen therapy for long COVID (HOT-LoCO), an interim safety report from a randomised controlled trial

    Background

    With ~ 50 million individuals suffering from post-COVID condition (PCC), low health related quality of life (HRQoL) is a vast problem....

    Anders Kjellberg, Adrian Hassler, ... Peter Lindholm in BMC Infectious Diseases
    Article Open access 20 January 2023
  7. Flexible bronchoscopy insufflated and high-flow nasal oxygen pilot trial (BUFFALO protocol pilot trial)

    Background

    Hypoxaemia occurs in approximately 30% of children during anaesthesia for flexible bronchoscopy. High-flow nasal oxygen (HFNO) can prolong...

    Susan Humphreys, Andreas Schibler, ... Britta S von Ungern-Sternberg in Pilot and Feasibility Studies
    Article Open access 29 February 2024
  8. Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

    Background

    Design and implementation of multi-country clinical trials for multidrug-resistant tuberculosis (MDR-TB) are complex for several reasons,...

    Leena N. Patel, Meera Gurumurthy, ... I. D. Rusen in Trials
    Article Open access 23 January 2023
  9. Develo** principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey

    Background

    The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and...

    Martina Svobodova, Nina Jacob, ... Jeremy Howick in Trials
    Article Open access 08 October 2022
  10. 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

    Background

    Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability...

    Josephine S. F. Chow, Neil Boudville, ... David W. Johnson in Trials
    Article Open access 14 November 2023
  11. A report on parent involvement in planning a randomised controlled trial in neonatology and lactation – insights for current and future research

    Background

    Patient and Public Involvement (PPI) is a rich and valuable part of the process of planning, designing, carrying out and disseminating...

    Ilana Levene, Fiona Alderdice, ... Maria A. Quigley in International Breastfeeding Journal
    Article Open access 14 September 2022
  12. Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)

    Background

    Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to...

    C. E. Arundel, L. K. Clark, ... S. Treweek in Trials
    Article Open access 12 March 2024
  13. Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy

    Background

    Hypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is...

    Ahmed S.Z. Moustafa, Wondwosen Yimer, ... Kedra Wallace in BMC Pregnancy and Childbirth
    Article Open access 03 May 2024
  14. NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial

    Introduction

    Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or...

    Niklas Breindahl, Tine Brink Henriksen, ... Lise Aunsholt in Pediatric Research
    Article Open access 11 January 2024
  15. 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

    Background

    A significant proportion of Canadian adults is impacted by chronic noncommunicable diseases. These conditions may be improved by peer-led...

    Margherita Cameranesi, Rebecca Mollard, ... Dylan MacKay in Trials
    Article Open access 24 October 2023
  16. Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective

    Background

    In early 2021, the Department of Health and Social Care in the UK called for research on the safety and immunogenicity of concomitant...

    Rosie Harris, Russell Thirard, ... Chris A. Rogers in Trials
    Article Open access 23 January 2024
  17. Exploring implementation outcomes in the clinical trial context: a qualitative study of physician trial stakeholders

    Introduction

    Cancer clinical trials can be considered evidence-based interventions with substantial benefits, but suffer from poor implementation...

    Kristian D. Stensland, Anne E. Sales, ... Ted A. Skolarus in Trials
    Article Open access 27 April 2023
  18. 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)

    Background

    Rotator cuff (RC) tendinopathy is the most reported shoulder disorder in the general population with highest prevalence in overhead...

    Birgitte Hougs Kjær, Ann M. Cools, ... Peter S. Magnusson in Trials
    Article Open access 21 February 2024
  19. 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...

    Emma Kwan-Yee Ho, Ralph Jasper Mobbs, ... Manuela Loureiro Ferreira in Trials
    Article Open access 06 December 2023
  20. Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods

    Background

    Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not...

    Jane M. Liebschutz, Geetha A. Subramaniam, ... Jennifer McNeely in Addiction Science & Clinical Practice
    Article Open access 18 November 2023
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