Core Outcome Measures in Effectiveness Trials

COMBINE -Core Outcome Measures in Brachial plexus INjuriEs

General Information

A traumatic brachial plexus injury (TBPI) involves major trauma to the large nerves of the arm which control the movement and sensation. Young people most frequently suffer a TBPI following road traffic accidents. Fifty percent of injuries result in complete paralysis of the arm with some individuals having little movement, loss of sensation and unremitting pain. The injury often causes severe and permanent disability affecting work and social life, which costs the NHS and the economy £35 million per annum. Improved survival rates following major trauma has seen an increase in TBPI.

Developments in microsurgery mean more patients undergo repeated surgery and intensive postoperative rehabilitation over many years. Multiple outcomes are assessed following interventions including short-term clinical impairments (pain and power) and long-term functioning and quality of life. There is no consensus on what outcomes are most important to assess and which are relevant to patients. This has impeded our ability to combine and contrast different studies of effectiveness and decide what works best.

The aim of this project is to enhance evidence-based practice for adults with a TBPI by developing a COS and identifying outcome measures which can assess the COS. The COS will be relevant to individuals with TBPI following surgery or conservative management for use in clinical practice and research.

Principal Investigator: Caroline Miller, Physiotherapy Department, Therapy Services, Queen Elizabeth Hospital, University Hospitals Birmingham Foundation NHS trust, B15 2TH.

Professor Christina Jerosch-Herold School of Health Sciences, University of East Anglia, Norwich NR4 7TJ,UK Email:

Dr Jane Cross School of Health Sciences, University of East Anglia, Norwich NR4 7TJ,UK Email:

Mr Dominic Power University Hospitals Birmingham Mindelsohn Way B15 2WB Email:


Professor Melanie Calvert,
Director of Centre for Patient Reported Outcomes School of Health and Population Science University of Birmingham

Dr Derek Kyte,
Lecturer in Health Research Methods at the University of Birmingham UK and NIHR Fellow,
Institute of Applied Health Science
University of Birmingham

Charity support Traumatic Brachial Plexus Injury charity

Further Study Information

Current Stage:
May 2018 - May 2022
Funding source(s):
This research is funded by the National Institute of Health Research and Health Education England through a Clinical Doctoral Research Fellowship ICA -CDRF- 2017-03-039

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Traumatic brachial plexus injury

Target Population

Age Range
16 - 100


Nature / type of Intervention


Consensus meeting
Delphi process
Systematic review

Plan of Investigation
“What to measure”
Phase 1: Develop “long list” of outcomes
A systematic review will identify outcomes reported in the TBPI literature.
Interviews with individuals with TBPI and families will identify outcomes important to those affected by TBPI.
Outcomes identified through the literature and interviews will be combined and grouped to create a “long list”. Descriptors of outcomes will be agreed with the steering group and the patient advisory group.

Phase 2: Consensus on final COS
Health professionals, patients and academics will participate in an online 3 round Delphi to prioritise the “long list” of outcomes. A consensus meeting, including health professionals and patients will review and ratify the outcomes priorities in the Delphi and the final COS-TBPI.

Phase 3: Existing measures, which assess the domains of the COS-TBP will be identified. Studies on the psychometric properties of outcome measured will be assessed using COSMIN criteria. Any gaps in available outcome measures for any domains of the COS-TBPI will be identified.

Stakeholders Involved

Clinical experts
Consumers (patients)
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research
COS for practice

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.