Deshmukh, Sandeep Rajiv, Montgomery, Alan and Karantana, Alexia
(2023)
Developing a core outcome set for hand fractures and joint injuries in adults.
PhD thesis, University of Nottingham.
Abstract
Background
Hand fractures and joint injuries are common, with significant impact for patients themselves but also on a wider societal and economic level through healthcare costs and productivity loss. Despite the clear significance of these injuries, there is not a consensus on optimal treatment. The variety of treatment options together with a lack of consistency in outcome reporting and research method standards makes interpretation of the available evidence challenging.
One solution is a core outcome set, which aims to set the minimum outcome measurements in any clinical study. This would improve consistency and comparability between studies, facilitating meta-analysis.
Aim
The overarching aim was to work towards development of 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 was to establish ‘what’ should be measured when considering the outcome of hand fracture and joint injury management.
Methods
This was a mixed methods study to develop a core outcome set for clinical trials of hand fractures and joint injuries, with initial scoping work to clarify the set of injuries intended to be covered by the core outcome set, analysis of data from a UK Major Trauma Centre to determine a sense of the scale of the incidence of hand fractures, and then phases of outcome domain generation and consensus prioritisation to reach the final core outcome set. The specific steps were:
• Defining the scope of injuries to be addressed by the core outcome set through one-to- one discussions with expert stakeholder consultation with hand surgeons and therapists
• Collecting data from reports of all hand and wrist radiographs from Queen’s Medical Centre (Nottingham) over a one-year period to assess the incidence and anatomical distribution of fractures.
• A systematic review of randomised/quasi-randomised controlled studies and large (≥100 participant) prospective observational studies on treatment of hand fractures and joint injuries to identify outcomes selected in recently published studies. An assessment of outcome reporting bias was also conducted
• Extensive exploratory qualitative research with the patient stakeholder group, to identify their perspective on the injury, treatment and outcomes important to them and to generate outcome domains as well as descriptors using an inductive, thematic approach
• Initial consensus prioritisation of a longlist of outcome domains developed through synthesis of the systematic review and qualitative work through an international three-round Delphi survey
• A final consensus meeting using an adapted nominal group technique format, involving all key stakeholders, to reach consensus on a final core outcome set.
Main findings
In the systematic review of 160 studies vast heterogeneity in outcome selection was found. There were 639 unique outcomes, which were rationalised to 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health framework. Outcome reporting bias was evident, with only a minority of outcomes appropriately reported across these studies.
To explore which outcomes were relevant to patients with hand fractures and joint injuries, a qualitative study was conducted involving interviews (25 patients) and focus groups (five groups involving a total of 21 patients). A total of 35 outcome domains grouped within six broad themes were generated, along with descriptors for the domains.
The two streams of outcome domains were synthesised to form a longlist of 37 domains that entered a consensus process beginning with an online international Delphi survey. From the original 152 participants who began the survey, 144 (>94%) completed all three rounds (54 patients, 55 hand surgeons, 35 hand therapists). Based on pre-defined consensus criteria, 20domains reached consensus as ‘very important’ and the remainder reached no consensus.
All outcome domains were discussed at a final consensus meeting with 27 participants (12 patients, seven surgeons, six hand therapists, a health economist and a trial manager). The domains reaching no consensus were discussed and voted upon, with none reaching threshold to salvage and consider for the core outcome set. The 20 ‘consensus in’ domains were discussed and underwent iterative prioritisation steps. A final vote selected seven outcome domains for inclusion in the core outcome set: fine hand use, pain / discomfort at rest, pain / discomfort with activity, self-hygiene / personal care, return to usual work / job, range of movement, and patient satisfaction with outcome / result.
Conclusion
This study has shown the magnitude of the inconsistency in outcome selection for clinical research on hand fractures and joint injuries in adults. A core outcome set to help address this issue was developed based on exploration of the existing literature and the patient perspective. Through a subsequent systematic consensus process, the longlist of outcome domains was refined to a final set of seven core outcome domains. These touch upon several bases including functional tasks (covering basic aspects and a working life role), patient comfort, abstract function (range of motion) and patient satisfaction. They are recommended as the baseline domains to be measured in future clinical research on these injuries, with the optimum way to measure the domains being the subject of future work.
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