Identifying outcomes for distal tibia and ankle fractures v1.0
Research type
Research Study
Full title
Towards a core outcome set for fractures of the distal tibia and ankle: identifying important outcomes
IRAS ID
277752
Contact name
Kirstie Haywood
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
This study is part of an iterative research project that seeks to develop a core outcome set for fractures of the distal tibia and ankle (COSTA). The first stage in developing COSTA is to develop a long list of important outcomes from both the patient and healthcare professional perspective. To do this, we propose a two-stage study:
Stage 1: Interviews with patients to explore their experiences and recovery from distal tibia and ankle fractures. This stage will draw on interpretative phenomenological analysis (IPA) as its methodology, and involve up to 30 semi-structured interviews with patients. Thematic analysis (TA) will be used to derive an outcomes framework to underpin the outcomes list. A separate IPA will be conducted on a subset of interviews to make a separate contribution to our understanding of lived experience and recovery of a distal tibia and ankle fracture.
Stage 2: focus groups (or interviews where more convenient for busy professionals) with healthcare professionals (HP) to identify important outcomes from the HP perspective. Up to 4 focus groups will be conducted with up to 12 participants per group. Similar to stage 1, this stage will use TA to derive a list of important outcomes but from the HP perspective. Focus groups will be conducted in two phases: firstly, a group discussion of the findings of two reviews of outcome reporting conducted by the research team in (i) randomised controlled trials, and (ii) qualitative studies. Phase 2 will be an active group discussion to generate a HP outcomes list. Where focus groups are not possible, interviews will be used instead.
The long lists of outcomes derived from stages 1 and 2 will be used in future as part of an e-Delphi survey (outside of this application).REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1147
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion