Pearson, Nathan, Tutton, Elizabeth, Joeris, A., Gwilym, S., Grant, R., Keene, D. J. and Haywood, Kirstie L. (2021) Co-producing a multi-stakeholder core outcome set for distal tibia and ankle fractures (COSTA) : a study protocol. Trials, 22 . 443. doi:10.1186/s13063-021-05415-1 ISSN 1745-6215.

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Abstract

Background:
Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce – with patient partners and other key stakeholders – a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials.

Methods:
The study will have five-stages which will include: i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; v) and an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set.

Discussion:
Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General) R Medicine > RD Surgery
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing
Library of Congress Subject Headings (LCSH):	Outcome assessment (Medical care), Clinical trials -- Evaluation, Tibia -- Fractures -- Treatment, Ankle -- Fractures -- Treatment
Journal or Publication Title:	Trials
Publisher:	Biomed Central
ISSN:	1745-6215
Official Date:	12 July 2021
Dates:	Date Event 12 July 2021 Published 1 July 2021 Accepted
Volume:	22
Article Number:	443
DOI:	10.1186/s13063-021-05415-1
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	6 July 2021
Date of first compliant Open Access:	13 July 2021
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID UNSPECIFIED AO Foundation http://dx.doi.org/10.13039/501100001702
Is Part Of:	1
Related URLs:	Publisher

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