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Researchers' experiences of the design and conduct challenges associated with parallel-group cluster-randomised trials and views on a novel open-cohort design.
Surr, Claire; Marsden, Laura; Griffiths, Alys; Cox, Sharon; Fossey, Jane; Martin, Adam; Prevost, A Toby; Walshe, Catherine; Walwyn, Rebecca.
Afiliación
  • Surr C; Centre for Dementia Research, Leeds Beckett University, Leeds, United Kingdom.
  • Marsden L; Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
  • Griffiths A; Institute of Population Health, University of Liverpool, Liverpool, United Kingdom.
  • Cox S; Department of Behavioural Science and Health, UCL, London, United Kingdom.
  • Fossey J; Faculty of Health and Life Sciences, University of Exeter, Exeter, United Kingdom.
  • Martin A; Academic Unit of Health Economics, University of Leeds, Leeds, United Kingdom.
  • Prevost AT; Nightingale-Saunders Clinical Trials & Epidemiology Unit, Kings College London, London, United Kingdom.
  • Walshe C; International Observatory on End of Life Care, Lancaster University, Lancaster, United Kingdom.
  • Walwyn R; Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
PLoS One ; 19(2): e0297184, 2024.
Article en En | MEDLINE | ID: mdl-38394190
ABSTRACT

BACKGROUND:

Two accepted designs exist for parallel-group cluster-randomised trials (CRTs). Closed-cohort designs follow the same individuals over time with a single recruitment period before randomisation, but face challenges in settings with high attrition. (Repeated) cross-sectional designs recruit at one or more timepoints before and/or after randomisation, collecting data from different individuals present in the cluster at these timepoints, but are unsuitable for assessment of individual change over time. An 'open-cohort' design allows individual follow-up with recruitment before and after cluster-randomisation, but little literature exists on acceptability to inform their use in CRTs.

AIM:

To document the views and experiences of expert trialists to identify a) Design and conduct challenges with established parallel-group CRT designs,b) Perceptions of potential benefits and barriers to implementation of open-cohort CRTs,c) Methods for minimising, and investigating the impact of, bias in open-cohort CRTs.

METHODS:

Qualitative consultation via two expert workshops including triallists (n = 24) who had worked on CRTs over a range of settings. Workshop transcripts were analysed using Descriptive Thematic Analysis utilising inductive and deductive coding.

RESULTS:

Two central organising concepts were developed. Design and conduct challenges with established CRT designs confirmed that current CRT designs are unable to deal with many of the complex research and intervention circumstances found in some trial settings (e.g. care homes). Perceptions of potential benefits and barriers of open cohort designs included themes on approaches to recruitment; data collection; analysis; minimising/investigating the impact of bias; and how open-cohort designs might address or present CRT design challenges. Open-cohort designs were felt to provide a solution for some of the challenges current CRT designs present in some settings.

CONCLUSIONS:

Open-cohort CRT designs hold promise for addressing the challenges associated with standard CRT designs. Research is needed to provide clarity around definition and guidance on application.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Investigadores Límite: Humans Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Investigadores Límite: Humans Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido