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. 2021 Jul 12;22(1):443.
doi: 10.1186/s13063-021-05415-1.

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Nathan A Pearson  1 , Elizabeth Tutton  2   3 , Alexander Joeris  4 , Stephen Gwilym  2 , Richard Grant  5   6   7 , David J Keene  2 , Kirstie L Haywood  8
Affiliations

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Nathan A Pearson et al. Trials. .

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 the following: (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; and (v) 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.

Keywords: Ankle fracture; Core outcome sets; Delphi study; Distal tibia; Interviews; Malleolar; Systematic review; Trauma; injury.

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Conflict of interest statement

All authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
Flow diagram illustrating the process of developing COSTA
See this image and copyright information in PMC

References

    1. Curtis EM, van der Velde R, Moon RJ, van den Bergh JPW, Geusens P, de Vries F, et al. Epidemiology of fractures in the United Kingdom 1988-2012: variation with age, sex, geography, ethnicity and socioeconomic status. Bone. 2016;87:19–26. doi: 10.1016/j.bone.2016.03.006. - DOI - PMC - PubMed
    1. Jennison T, Brinsden M. Fracture admission trends in England over a ten-year period. Ann R Coll Surg Engl. 2019;101(3):208–214. doi: 10.1308/rcsann.2019.0002. - DOI - PMC - PubMed
    1. Forsberg A, Söderberg S, Engström Å. People’s experiences of suffering a lower limb fracture and undergoing surgery. J Clin Nurs. 2014;23(1–2):191–200. doi: 10.1111/jocn.12292. - DOI - PubMed
    1. Stufkens SAS, van den Bekerom MPJ, Kerkhoffs GMMJ, Hintermann B, van Dijk CN. Long-term outcome after 1822 operatively treated ankle fractures: a systematic review of the literature. Injury. 2011;42(2):119–127. doi: 10.1016/j.injury.2010.04.006. - DOI - PubMed
    1. Trickett RW, Mudge E, Price P, Pallister I. A qualitative approach to recovery after open tibial fracture: the road to a novel, patient-derived recovery scale. Injury. 2012;43(7):1071–1078. doi: 10.1016/j.injury.2012.01.027. - DOI - PubMed

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