التفاصيل البيبلوغرافية
| العنوان: |
Fluidity of Equipoise in a Multi-Centred Pilot RCT: Influences on Clinician Decision-Making in Offering Trial Entry. |
| المؤلفون: |
Molloy, Eleanor1 (AUTHOR) e.molloy@bham.ac.uk, Pilarski, Nicole1,2 (AUTHOR), Morris, Katie1,2 (AUTHOR), Hodgetts-Morton, Victoria1,2 (AUTHOR), Jones, Laura1 (AUTHOR) |
| المصدر: |
European Journal of Obstetrics & Gynecology & Reproductive Biology. May2024, Vol. 296, p170-178. 9p. |
| مصطلحات موضوعية: |
*MEDICAL personnel, *CERVICAL cerclage, *PREMATURE labor, *THEMATIC analysis, *DECISION making, *BALANCE disorders |
| مستخلص: |
• Even where community equipoise exists, individual clinician equipoise may be fluid. • Equipoise may be fluid for individuals and vary between study sites. • Fluidity of equipoise was influenced by clinician experience of emergency cerclage. • Obstetric history may influence clinical equipoise in maternity/ preterm birth trials. • Immediate clinical presentation at diagnosis influenced equipoise in CSTICH-2 Pilot. • Understanding fluidity of equipoise specific to trial context supports recruitment. 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). 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. 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'. 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. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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