Aims
The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults.
Methods
Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set.
Results
The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as ‘very important’ for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result.
Conclusion
This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries.
Mr Sandeep Deshmukh, Research fellow PhD student, University of Nottingham – Co-principal investigator
Dr Alexia Karantana, Clinical Associate Professor in Hand Surgery, Centre for Evidence Based Hand Surgery, University of Nottingham – Co-principal investigator & supervisor
Professor Alan Montgomery, Professor of Medical Statistics and Clinical Trials, Nottingham Clinical Trials Unit, University of Nottingham – Co-investigator & supervisor
Dr Paul Leighton, Associate Professor of Applied Health Services Research, University of Nottingham – Co-investigator & supervisor
Professor Christina Jerosch-Herold, Professor of Rehabilitation Research, School of Health Sciences, University of East Anglia
Co-investigator
Mr Jeremy Rodrigues, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford
Co-investigator
Mr Ryan Trickett, Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff
Co-investigator
Professor Matthew Costa, Professor of Orthopaedic Trauma Surgery, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford
Co-investigator
Mr Xavier Griffin, Associate Professor of Trauma Surgery, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford
Co-investigator
Disease Category: Orthopaedics & trauma
Disease Name: Hand fractures, Fractures, Joint injuries
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review
This is a mixed methods study involving four phases to develop a core outcome set for clinical trials of hand fractures and joint injuries. This will be informed by the process outlined by Williamson et al. (5) and Kirkham et al. (6, 7) and will include
• a systematic review to identify ‘existing knowledge’;
• extensive exploratory qualitative research with key stakeholders (with key emphasis on patients) to identify and highlight their perspective on the injury, its treatment and outcomes which are important to them;
• a consensus exercise to develop shortlist of outcome domains; and
• a consensus meeting, involving all key stakeholders, to synthesise the different strands of data and reach final consensus on a core outcome set.
References:
1. Scholes S, Panesar S, Shelton NJ, Francis RM, Mirza S, Mindell JS, et al. Epidemiology of lifetime fracture prevalence in England: a population study of adults aged 55 years and over. Age Ageing. 2014 Mar;43(2):234-40. PubMed PMID: 24231585. Epub 2013/11/16. eng.
2. Handoll HHG, Vaghela MV. Interventions for treating mallet finger injuries. Cochrane Database of Systematic Reviews. 2004 (3). PubMed PMID: CD004574.
3. Poolman RW, Goslings JC, Lee J, Statius Muller M, Steller EP, Struijs PAA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database of Systematic Reviews. 2005 (3). PubMed PMID: CD003210.
4. Verver D, Timmermans L, Klaassen RA, van der Vlies CH, Vos DI, Schep NWL. Treatment of extra-articular proximal and middle phalangeal fractures of the hand: a systematic review. Strategies in Trauma and Limb Reconstruction. 2017 03/04
10/04/received
02/24/accepted;12(2):63-76. PubMed PMID: PMC5505877.
5. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012 August 06;13(1):132.
6. Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al. Core Outcome Set-STAndards for Development: The COS-STAD recommendations. PLOS Medicine. 2017;14(11):e1002447.
7. Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al. Core Outcome Set–STAndards for Reporting: The COS-STAR Statement. PLOS Medicine. 2016;13(10):e1002148.