Speaker: Clare Jinks, Marion Campbell, Katie Mellor, Nicola Cornwall, Matilda Björklund, Shaun Treweek
This is a spotlight session at the 2024 International Clinical Trials Methodology Conference (ICTMC). See also https://inconference.eventsair.com/ictmc-2024
Register here: https://ictmc.org/registration-2/
Abstract
Embedding qualitative research in pilot and feasibility randomised controlled trials (RCTs) is widely recognised as important when evaluating uncertainty about feasibility and acceptability of new interventions or trial processes. This awareness has grown at the same time as calls for researchers undertaking pilot and feasibility trials to pre-specify progression criteria in their trial methodology. Progression criteria are predominantly quantitative, with progression decision making often one sided appearing to be based on achieving or exceeding numerical targets, and not based on all available knowledge that often cannot be pre-specified. Despite evidence for the benefit of qualitative research in pilot and feasibility studies, underuse of qualitative findings in the progression decision-making process limits the strength of interpretations made and the comprehensiveness of conclusions about acceptability and feasibility that are drawn. One sided progression decisions can, therefore, lead to suboptimal intervention or trial refinement ahead of the next stage of evaluation.
Decision-making about progression in pilot and feasibility trials fits the criteria for a spotlight session as the topic is particularly timely given the publication of recent guidance on applying mixed methods to pilot feasibility studies to inform intervention trials (Aschbrenner et al, 2022) and recommendations for researchers on development and use of progression criteria (Mellor et al 2023). Current qualitative research also highlights that researchers involved in trials are not aware of this guidance. The topic also aligns with conference themes of innovation in qualitative and mixed methods in trials and trial integrity. The session will facilitate capacity building by allowing a PhD student to present work alongside experts in trials methodology, and for an ECR to facilitate the discussion section alongside a more experienced methodologist.
The aims of this spotlight session are to:
1) Showcase the topic of mixed methods decision-making about progression in pilot and feasibility studies
2) Highlight advances in the field of decision making
3) Discuss challenges to and opportunities for optimising decision making in trials methodology.
Speakers include:
1. Professor Marion Campbell (Chair Better Methods Better Research Panel and Professor of Health Services Research)
2. Dr Katie Mellor (Clinical Outcome Assessment Associate)
3. Dr Nicola Cornwall (Lecturer in Applied Health Research)
4. Ms Matilda Björklund (Postgraduate Researcher)
5. Professor Shaun Treweek (Trial Forge Lead and Professor of Health Services Research)
Session Organizer: Professor Clare Jinks (Professor of Health Research)
Panel/Audience discussion: Thinking differently about processes for pilot and feasibility trial progression decision making and reporting (30 mins)
