Title: Improving the quality and relevance of outcome measurement for patients with Traumatic Brachial Plexus Injury: Development of an International Core Outcome Set
Funder: Health Education England

Abstract: Traumatic Brachial Plexus Injury (TBPI) involves major trauma to the large nerves of the arm, which control movement and provide sensation. Each year, 500 new young people in England and Wales suffer a TBPI following road traffic accidents. Fifty percent of injuries result in complete paralysis of the arm. Some individuals may have little movement, loss of feeling 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 post-operative rehabilitation over many years. Multiple outcomes are assessed following interventions including short-term clinical impairment (pain and muscle power) and long-term functioning and quality of life. There is no consensus on what outcomes are the 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 development and implementation of a Core Outcome Set (COS) relevant to patients, clinicians and the NHS, which could be used in trials and clinical practice, would help address these issues. It would enable comparison of treatments, facilitate evidence synthesis, reduce outcome-reporting bias and ensure that evaluations of interventions are patient focused.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 a minimum set that will not preclude inclusion of other outcomes. It will be relevant to individuals with TBPI following surgery or conservative management for use in clinical practice and research.Plan of Investigation What to measureWork Package 1: Develop long-list of outcomes A systematic review will identify all 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.Work Package 2: Consensus on final COS Health professionals, patients and families 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 prioritised in the Delphi and agree on the final COS-TBPI.How to measureWork Package 3: Identify existing reliable and valid measures, which can assess the COS-TBPI. Existing measures, which assess the domains of the COS-TBPI, will be identified. Studies on the psychometric properties of outcome measures will be assessed using COSMIN criteria. Any gaps in available outcome measures for any domains of the COS-TBPI will be identified.Benefits to Patients, NHS and International Community: Developing this COS with patients will ensure that outcomes measured are relevant to all stakeholders. Surgical, conservative and new health technology interventions can be evaluated using this COS. Evaluating short and long term outcomes will ensure that no important beneficial or adverse outcomes are omitted in this complex group of patients. Improving evidence synthesis will help guideline development and influence clinical practice. Commissioners can use this COS to evaluate current services. Patient centred services can be redesigned.Dissemination: I aim to achieve professional endorsement of this COS within clinical practice and research. Key organisations such as British Association of Hand Therapy and Reconstructive Surgical Trials Network are supportive and will publish updates in their subscriber bulletins. I will publish papers in peer- reviewed journals.

Lay abstract: A Traumatic Brachial Plexus Injury (TBPI) is a severe injury to the large nerves of the arm, which supply feeling and movement to the limb. It is most commonly sustained during a motorcycle accident. Although some people regain slight movement, over half of injured patients live with a completely paralysed arm. In England and Wales there are 500 new injuries in young adults in their twenties and thirties every year. This number is rising as more people survive major accidents. The injury is often accompanied by severe and constant pain and a person can be left with life-long disabilities, affecting their work and social life. This costs the NHS and the economy 35 million per year. However, recently there have been advancements in surgery and other treatments. Now, many patients undergo months and years of surgery and therapy in an attempt to restore movement, feeling and strength of the arm. But, there is no agreement on what should be measured following injury or surgery to monitor progress and determine what treatments work best. Patients and healthcare professionals prioritise different outcomes (also called aspects of health). Muscle strength is commonly measured in studies. However, it fails to cover other important aspects of health such as daily functioning, pain, psychological and social wellbeing. Many different aspects of health are reported in studies on TBPI, which makes it difficult to compare the results.The aim of this research is to establish a Core Outcome Set (COS) for this patient group. A COS is a minimum set of aspects of health that is important to measure in a group of patients. This will be done by finding out what aspects of health are important in people with TBPI and then determining what tools are best to measure these outcomes. The study will be conducted in three stages. Stage 1: What to measure? I will interview individuals with TBPI to gain their views on what should be measured. I will also review published studies to identify which aspects of health have previously been measured and how they were measured. From this I will generate a long list of aspects of health (e.g. pain, movement) relevant to TBPI.Stage 2: Reaching agreement (consensus) on what to measureI will work with patients and healthcare professionals to turn this long list into a three round online questionnaire called a Delphi method. People with TBPI and health professionals will rate the importance of each aspect of health. After individuals complete the questionnaire the highest scoring items are kept and lower scoring ones are removed. Individuals receive feedback on the scores from each of the groups and asked to score again. This process is repeated until broad agreement is reached. This will produce a short list of the important aspects of health (outcomes). I will then invite patients and professionals to attend a meeting to agree on the final list called a Core Outcome Set (COS). This will involve a discussion around outcomes where consensus could not be reached. Everyone will vote on the final core outcome set for TBPI.Stage 3: How to measure?I will examine the literature for valid and reliable ways to measure each of the outcomes in individuals with TBPI that make up the COS.This research will improve patient care by establishing which outcomes should be measured after a Traumatic Brachial Plexus Injury and how to measure them.Clinicians will consistently measure outcomes, which are meaningful and relevant to patients with this injury. Researchers will use the same measures in studies so it is easier to combine and compare the results of different studies. This will allow patients and clinicians to make better judgments on what treatments work. New services or treatments designed to target these outcomes can be developed. Existing services can be measured against these outcomes, allowing comparison across different hospitals and raise standards of care. Patients and Public involvement has been integral to this proposal. I have worked with the UK Traumatic Brachial Plexus Injury Charity to refine the research question and study design. They have agreed to advertise the questionnaire. Patients will help design the interviews, information leaflets and the questionnaire for the Delphi so it is easy to understand. There will be a patient representative on the study management team. Publications in journals and conference presentations will inform health care professionals and researchers of the results. Patient representatives and I will write blogs on the UK Traumatic Brachial Plexus Charity Website documenting each step of the study.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS;NEUROLOGICAL