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Fluidity of Equipoise in a Multi-Centred Pilot RCT: Influences on Clinician Decision-Making in Offering Trial Entry.
Molloy, Eleanor; Pilarski, Nicole; Morris, Katie; Hodgetts-Morton, Victoria; Jones, Laura.
Afiliación
  • Molloy E; Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT. Electronic address: e.molloy@bham.ac.uk.
  • Pilarski N; Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT; Birmingham Women's and Children's Hospital, Edgbaston, Birmingham B15 2TG.
  • Morris K; Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT; Birmingham Women's and Children's Hospital, Edgbaston, Birmingham B15 2TG.
  • Hodgetts-Morton V; Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT; Birmingham Women's and Children's Hospital, Edgbaston, Birmingham B15 2TG.
  • Jones L; Institute for Applied Health Research, Murray Learning Centre, University of Birmingham, Edgbaston, Birmingham B15 2TT.
Eur J Obstet Gynecol Reprod Biol ; 296: 170-178, 2024 May.
Article en En | MEDLINE | ID: mdl-38452529
ABSTRACT

OBJECTIVES:

The embedded Qualitative Process Evaluation (QPE) within the CSTICH- Pilot RCT explored facilitators and barriers to recruitment within the Pilot. This study reports a secondary analysis of the overarching theme of Fluidity of Equipoise and the influences on individual and community clinical equipoise around the use of Emergency Cervical Cerclage (ECC). STUDY

DESIGN:

RCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention. The ability of trial recruiters to convey this equipoise is also key to participant recruitment and fully informed consent. This exploratory qualitative process evaluation used semi-structured interviews with healthcare professionals (HCPs) involved in trial recruitment. Interviews were audio-recorded, transcribed, and analysed using codebook thematic analysis.

RESULTS:

23 HCPs were interviewed. Clinical equipoise around the use of ECC was variable and influenced by a multitude of factors including (1) obstetric history; (2) gestation; (3) standard site practice, and (4) HCPs previous experiences of ECC. We have interpreted this variability as 'fluidity of equipoise'.

CONCLUSIONS:

Clinical equipoise around complex pregnancy related conditions was fluid and influenced by the complexities of obstetric histories and gestation at presentation. Equipoise of HCPs involved in trial recruitment should be considered carefully as it can impact the nuances of recruitment, particularly in more challenging trials such as CSTICH-2. Study-specific documents and training can be used to increase staff and patient awareness of uncertainty in the evidence base for interventions under investigation. Further research is needed around the potential consequences of equipoise fluidity.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Personal de Salud / Consentimiento Informado Límite: Humans Idioma: En Revista: Eur J Obstet Gynecol Reprod Biol Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Personal de Salud / Consentimiento Informado Límite: Humans Idioma: En Revista: Eur J Obstet Gynecol Reprod Biol Año: 2024 Tipo del documento: Article Pais de publicación: Irlanda