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Development of a core outcome set for traumatic brachial plexus injuries (COMBINE): study protocol
  1. Caroline Miller1,2,
  2. Jane Cross1,
  3. Dominic M Power3,
  4. Derek Kyte4,5,
  5. Christina Jerosch-Herold1
  1. 1 School of Health Sciences, University of East Anglia, Norwich, UK
  2. 2 University Hospitals Birmingham NHS Foundation Trust, Physiotherapy Department, Queen Elizabeth Hospital, Birmingham, UK
  3. 3 The Birmingham Peripheral Nerve Injury Service, Queen Elizabeth Hospital Birmingham, Birmingham, UK
  4. 4 Centre for Patient-Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  5. 5 NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
  1. Correspondence to Mrs Caroline Miller; caroline.miller{at}uea.ac.uk

Abstract

Introduction Traumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Fifty per cent of injuries result in complete paralysis of the arm with many other individuals having little movement, sensation loss and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, with an estimated cost to the National Health Service and the economy of £35 million per annum. Advances in microsurgery have resulted in an increase in interventions aimed at reconstructing these injuries. However, data to guide evidence-based decisions is lacking. Different outcomes are used across studies to assess the effectiveness of treatments. This has impeded our ability to synthesise results to determine which treatments work best. Studies frequently report short-term clinical outcomes but rarely report longer term outcomes and those focused on quality of life. This project aims to produce a core outcome set (COS) for surgical and conservative management of TBPI. The TBPI COS will contain a minimum set of outcomes to be reported and measured in effectiveness studies and collected through routine clinical care.

Methods and analysis This mixed-methods project will be conducted in two phases. In phase 1 a long list of patient-reported and clinical outcomes will be identified through a systematic review. Interviews will then explore outcomes important to patients. In phase 2, the outcomes identified across the systematic review, and the interviews will be included in a three-round online Delphi exercise aiming to reach consensus on the COS. The Delphi process will include patient and healthcare participants. A consensus meeting will be held to achieve the final COS.

Ethics and dissemination The use of a COS in TBPI will increase the relevance of research and clinical care to all stakeholders, facilitate evidence synthesis and evidence-based decision making. The study has ethical approval.

Trial registration numbers CRD42018109843.

  • brachial plexus
  • core outcome set
  • qualitative research
  • consensus development
  • outcome measures

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Footnotes

  • Contributors CM wrote the paper and conceived the project with the support of CJ-H and DMP. JC contributed knowledge on qualitative research. DK contributed knowledge on core outcome set development. CJ-H, JC, DMP and DK edited and critically revised the paper. All authors have read and approved the manuscript.

  • Funding The work is supported by the Health Education England and National Institute for Health Research Clinical Doctoral Research Fellowship CDRF ICA-CDRF-2017-03-039.

  • Disclaimer This article presents research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health.

  • Competing interests DMK reports grants from Macmillan Cancer Support, Innovate UK, the National Institute for Health Research (NIHR), NIHR Birmingham Biomedical Research Centre and NIHR Surgical Reconstruction and Microbiology Research Centre at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust and personal fees from Merck outside the submitted work. DMP reports personal fees from Polyganics, personal fees from Axogen Inc and personal fees from Gecko-Biomedical outside the submitted work.

  • Ethics approval Ethical approval for the interviews, Delphi and consensus meeting was granted on 03/01/2019 by the West Midlands-Solihull Research Ethics Committee (Ref 18/WM/0297).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Patient consent for publication Not required.

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