An international multi-stakeholder delphi consensus exercise to develop a core outcomes set (COS) for surgical fixation of rib fractures

Introduction: A patient-relevant, focused Core Outcome Set (COS) is essential to the design of clinical trials dealing with chest wall trauma, in order to maximise quality of evidence regarding impact of inter- ventions and to reduce research waste. Methods: Outcome measures were collated by way of systematic review and entered into a three round Delphi consensus completed anonymously online. Participants were international clinicians and allied health professionals (AHP) involved in the treatment of rib fractures as well as patients who had ex- perienced severe chest trauma. Consensus thresholds for statements were defined a priori as a group rating of more than 70% or less than 15% for ‘important’ or ‘not important’. Results: Sixty-five participants responded to the first round and the final round Final round consisted of five AHP, two patients and 16 clinicians from eight different countries. Twenty-three outcomes were regarded as important for the COS; eight adverse events, three mortality, five clinical or physiological outcomes, six life impact and one resource-related. Health related quality of life was rated highest of the life impact outcomes but participants thought it was also important to assess disability, physical function, quality of life, return to activities and return to work. Conclusion: Collecting serious adverse outcomes was important to all stakeholders as were life impact outcomes such as quality of life, physical function and return to activities. Resource use outcomes were considered less important. We recommend this Core Outcome Set, developed with multiple relevant stakeholders, for use in future clinical trials, following further work on the most appropriate methods and instruments for measurement.

Link to protocol: https://sites.google.com/a/york.ac.uk/delphi-explanations/protocol

Contributors

Helen Ingoe - York Trials Unit/The James Cook University Hospital - Principal Investigator
Will Eardley - The James Cook University Hospital/York Trials Unit - Clinical Supervisor
Amar Rangan
Catherine Hewitt - York Trials Unit - Supervisor
Catriona McDaid - York Trials Unit - Supervisor

Publication

Journal: Injury
Volume:
Issue:
Pages: -
Year: 2019
DOI: https://doi.org/10.1016/j.injury.2019.10.031

Further Study Information

Current Stage: Not Applicable
Date: January 2018 - August 2018
Funding source(s): Orthopaedic Research UK


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Rib fracture, Fractures

Target Population

Age Range: 16 - 126

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Systematic review

Outcome measures were collated by way of systematic review and entered into a three round Delphi consensus completed anonymously online. Participants were international clinicians and allied health professionals (AHP) involved in the treatment of rib fractures as well as patients who had ex- perienced severe chest trauma. Consensus thresholds for statements were defined a priori as a group rating of more than 70% or less than 15% for ‘important’ or ‘not important’.

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