Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for hand fractures and joint injuries in adults

General Information

Summary:
Background:
Hand fractures and joint injuries are common, with a prevalence of ~20% of all fractures being hand fractures (1). They can have significant impact on patients and healthcare resources. There is a great variety in treatment modalities and this, along with a lack of consistency in outcome reporting and research methodology standards, makes it challenging to interpret the available evidence for clinical practice. Several reviews of the management of hand fractures and joint injuries highlight “inadequate outcome assessment” and “large variation in reported outcomes” (2-4), which hinders interpretation and meta-analysis. There is no consensus regarding the key health domains, or core outcome set (COS) which should be assessed following this group of injuries. This should be underpinned by an understanding of what is important to patients.

Aim:
To develop a Core Outcome Set for hand fractures and joint injuries in adults which will guide outcome assessment in future studies. The primary purpose of this project is to establish what should be measured when considering the outcome of hand fracture and joint injury management. ‘How’ this is measured (which specific outcome measurement instruments to use) and ‘how much’ constitutes a successful outcome, are not part of the initial process.

Contributors:
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

Professor Tim Davis, Honorary Professor in Trauma and Orthopaedics, Centre for Evidence Based Hand Surgery, University of Nottingham
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

Further Study Information

Current Stage:
Ongoing
Date:
October 2018 - March 2021
Funding source(s):
Centre for Evidence-Based Hand Surgery (CEBHS) (https://www.nottingham.ac.uk/research/groups/cebhs/index.aspx) The CEBHS is a collaboration between the British Society for Surgery of the Hand, The University of Nottingham and Nottingham University Hospitals NHS Trust, working with patients and the wider community of all those involved in hand surgery care.

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Fractures
Hand fractures
Joint injuries

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any

Method(s)

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.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Methodologists
Patient/ support group representatives
Policy makers
Researchers
Service providers

Study Type

COS for clinical trials or clinical research

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