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  1. Article

    Open Access

    The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids

    Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option...

    Jim Tiernan, Daniel Hind, Angus Watson, Allan J Wailoo in BMC Gastroenterology (2012)

  2. Article

    Open Access

    Use of home visits increases data completion and retention in studies involving family members

    Katie Biggs, Cindy Cooper in Trials (2015)

  3. Article

    Open Access

    The impact of ADHD on the health and well-being of ADHD children and their siblings

    Childhood attention-deficit/hyperactivity disorder (ADHD) has been associated with reduced health and well-being of patients and their families. The authors undertook a large UK survey-based observational stud...

    Tessa Peasgood, Anupam Bhardwaj, Katie Biggs in European Child & Adolescent Psychiatry (2016)

  4. Article

    Open Access

    Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II–III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial

    Haemorrhoids are a common condition, with nearly 30,000 procedures carried out in England in 2014/15, and result in a significant quality-of-life burden to patients and a financial burden to the healthcare sys...

    Abualbishr Alshreef, Allan J. Wailoo, Steven R. Brown in PharmacoEconomics - Open (2017)

  5. Article

    Open Access

    Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

    Adequate reporting of adaptive designs (ADs) maximises their potential benefits in the conduct of clinical trials. Transparent reporting can help address some obstacles and concerns relating to the use of ADs....

    Munyaradzi Dimairo, Elizabeth Coates, Philip Pallmann, Susan Todd in BMC Medicine (2018)

  6. Article

    Open Access

    Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial

    Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention.

    Katie Biggs, Daniel Hind, Mike Bradburn, Lizzie Swaby, Steve Brown in Trials (2019)

  7. No Access

    Chapter

    Transition of Care for Adolescents from Child to Adult Health Services: A Systematic Review

    The purpose of this systematic review was to evaluate the effectiveness of interventions designed to improve the transition of care for adolescents from paediatric to adult health services and explore what fac...

    Fiona Campbell, Susie Aldiss, Katie Biggs in Transition from Pediatric to Adult Healthc… (2020)

  8. Article

    Open Access

    Challenges in the design, planning and implementation of trials evaluating group interventions

    Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or heal...

    Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White in Trials (2020)

  9. Article

    Open Access

    The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

    Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. ...

    Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki in Trials (2020)

  10. Article

    Open Access

    Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project

    Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elem...

    Nikki Totton, Steven Julious, Dyfrig Hughes, Jonathan Cook, Katie Biggs in Trials (2021)

  11. Article

    Open Access

    Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project

    Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resource...

    Nina Wilson, Katie Biggs, Sarah Bowden, Julia Brown, Munyaradzi Dimairo in BMC Medicine (2021)

  12. Article

    Open Access

    Practical guidance for planning resources required to support publicly-funded adaptive clinical trials

    Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations...

    James M. S. Wason, Munyaradzi Dimairo, Katie Biggs, Sarah Bowden in BMC Medicine (2022)

  13. Article

    Open Access

    Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial

    In the UK, around 93,000 (0.8%) children and young people (CYP) are experiencing specific phobias that have a substantial impact on daily life. The current gold-standard treatment—multi-session cognitive behav...

    Han-I. Wang, Barry Wright, Lucy Tindall, Cindy Cooper, Katie Biggs in BMC Psychiatry (2022)

  14. Article

    Open Access

    Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice

    Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effectiv...

    Shoba Dawson, Katie Banister, Katie Biggs, Seonaidh Cotton, Declan Devane in Trials (2022)

  15. Article

    Open Access

    Correction: Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice

    Shoba Dawson, Katie Banister, Katie Biggs, Seonaidh Cotton, Declan Devane in Trials (2022)

  16. Article

    Open Access

    What is the purpose of clinical trial monitoring?

    The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitor...

    Sharon B. Love, Victoria Yorke-Edwards, Elizabeth Ward, Rebecca Haydock in Trials (2022)

  17. Article

    Open Access

    A methodological review of randomised n-of-1 trials

    n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r...

    Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs in Trials (2024)