COMBINE - Core Outcome Measures in Brachial plexus INjuriEs
Research type
Research Study
Full title
Improving the quality and relevance of outcome measurement for individuals with a Traumatic Brachial Plexus Injury. Development of an International Core Outcome Set
IRAS ID
248940
Contact name
Caroline Miller
Contact email
Duration of Study in the UK
3 years, 5 months, 29 days
Research summary
Research Summary
A Traumatic Brachial Plexus Injury is often sustained after a serious accident. It involves the large nerves which supply the feeling and the movement to the arm and hand. The consequences of a traumatic brachial plexus injury include severe and constant pain and loss of movement and feeling. Many patients undergo years of surgery and rehabilitation in an attempt to restore some movement and function of the arm.
To help patients, doctors and health professionals make decisions about treatments for a traumatic brachial plexus injury we need evidence about what works best. To do this we look at the effects of treatments on patients. These effects are called "outcomes" which might be muscle strength or quality of life measured after treatments. Currently, different studies measure different outcomes and when the studies are finished we cannot combine or compare the results. Also, outcomes chosen in a study may not be relevant to patients. This is problematic as we then struggle to work out if a treatment is effective and really helps patients.
We can solve this problem by using the same outcomes to decide whether treatments work called a Core Outcome Set. This study will develop a Core Outcome Set for traumatic brachial plexus injuries.
This study will be carried out over three phases.
1. We will interview patients with a Traumatic Brachial Plexus Injury to find out what outcomes are important to them. We will also review the literature to find out what outcomes have been reported.
2. These outcomes will be combined and turned into an online questionnaire. Patients and health professionals will rate the importance of each outcome over three rounds. Participants will then be invited to a meeting to discuss and agree on the Core Outcome Set.
3. We will examine the literature for the best ways to measure each outcome.Summary of Results
The aim of this study was to identify whether manual muscle testing (MRC test) in people with nerve injuries in the arm was reliable and if it correlated with improvement in function and quality of life. We assessed the reliability of manual muscle testing in 30 people with nerve injuries in the arms. We found that the MRC muscle rating scale for all muscles had poor reliability when two people conducted the testing. There was less than 50% agreement between pairs of ratings using this scale. However better upper limb strength as measured with the scale (combined individual muscle ratings) correlated significantly with better physical function and quality of life scores. From this study we provisionally recommend that the MRC scale should be used cautiously to measure outcome after a nerve injury in the upper limb as different tester get different scores making the result unreliable. Although higher combined muscle strength scores correlated with function and quality of life patient reported outcome measures are more patient centred ways to measure these outcomes
Summary of Research
The aim of the COMBINE study was to develop a core outcome set for adults with a traumatic brachial plexus injury. A core outcome set is a small number of outcomes health professionals and researchers should always measure in clinical practice and research. We can then more easily combine the results of studies and compare results of treatments to improve the evidence supporting care for people with a brachial plexus injury.
We reviewed one hundred and thirty-two published studies, and we interviewed 13 patients with a brachial plexus injury to find outcomes important to health professionals and those with the injury. We merged outcomes from the review and interviews and developed a 64-item international online questionnaire. Seventy -two people from nineteen countries completed all three rounds of the survey. This included 21 patients, 20 surgeons and 31 therapists. At the end of the three rounds we held separate patient and clinician meetings. Thirty-eight people from 9 countries attended. They agreed three outcomes were critically important to be measured and reported when treating and researching adults with a traumatic brachial plexus injury.
These three outcomes were Pain, Carrying out Daily Routine and Voluntary Movement.
We then reviewed the literature to find valid and reliable measures to assess these outcomes. At this time we would recommend that the BrAT (patient reported measure) is used to assess Carrying out Daily Routine and further consensus work is needed to reach agreement on how to measure Voluntary Movement and Pain.
In conclusion this project generated a core outcome set for adults with a traumatic brachial plexus injury. This should be used in future research and clinical practice. This will ensure that outcomes of importance to all stakeholders are measured and reported and will also help comparison of studies.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0297
Date of REC Opinion
29 Oct 2018
REC opinion
Favourable Opinion