Qualitative exploration of the wider effects of participating in a clinical trial for research and clinical staff.

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All Authors

Mcilvanna E.
Thiruvenkatachari B.
Sandler J.
Barber S.

LTHT Author

Mcilvanna, Emily

LTHT Department

Non Medic

Publication Date

2025

Item Type

Conference Abstract

Language

Subject

RESEARCH , QUALITATIVE RESEARCH , EDUCATION , STAFF DEVELOPMENT

Subject Headings

Abstract

Background: Delivering research may provide opportunities for professional and personal development for staff, yet few clinical trials have captured this. In this study, the wider impact of delivering a trial is explored across the duration of a multicentre RCT evaluating the effectiveness of nasoalveolar moulding (NAM) for children with unilateral complete cleft lip and palate in India (NAMUC Study). Objective(s): To explore researcher and clinician perception of being involved in research at the start of the trial. Method(s): Qualitative study using one-to-one interviews with research and clinical staffinvolved in delivering the NAMUC study. Ethical approval was awarded prior to commencement. One-to-one interviews were performed using a virtual platform by one experienced facilitator using a topic guide. Interviews were audiorecorded, transcribed, checked and anonymised. Analysis followed an inductive thematic approach by two researchers in duplicate. Result(s): Interviews were completed with 17 trial staff(8 clinicians, 9 researchers) between Nov 2022-Sept 2023 during trial setup. Some participants discussed that they initially had some concerns about equipoise due to NAM being current practice and a personal belief that it is effective. Individual's apprehensions about their own inexperience in research and ability to deliver were overcome by support and training from the Principal Investigator of the trial and trust in his leadership. motivation for working on the trial included improving cleft care, clinical upskilling, professional development and career progression. Perceived challenges included recruitment and retention of trial participants and ensuring complete and accurate data collection. Conclusion(s): Researchers and clinicians may choose to work on clinical trials to enhance patient care, clinical skills, professional development and career progression. Training, support and leadership may overcome individual's apprehension about their competency.Copyright © 2025

Journal

Journal of the World Federation of Orthodontists