Taha, Rowa
(2024)
Establishing the feasibility of a RCT comparing surgical versus non-surgical treatment for metacarpal shaft fractures in adults.
PhD thesis, University of Nottingham.
Abstract
Background
Metacarpal shaft fractures (MSF) are common traumatic injuries that predominantly affect young men of working age leading to functional impairment and consequently missed time off-work, leading to substantial societal costs. The aim of treatment is to restore hand function by maintaining the fracture in alignment until bone union, which is achieved either surgically using metalwork, or non-surgically by immobilisation in a splint or cast, with or without manipulation. Both treatment modalities require significant specialist resources, multiple hospital visits, and a period of rehabilitation of weeks to months, during which use of the hand is markedly restricted.
There is a lack of evidence to guide the treatment of MSF, with no consensus on the best management approach, therefore treatment varies throughout the country and within the international community. The lack of existing evidence supports the need for a well-designed, multi-centre randomised controlled trial (RCT) to identify the most effective and cost-efficient treatment for MSF in adults.
Aim
The overall aim of this thesis is to establish the feasibility and acceptability of conducting a multi-centre RCT comparing surgical and non-surgical treatment for MSF affecting the index to little finger in adults.
Methods
This was a mixed methods study consisting of multiple study arms, and findings were triangulated to inform future trial design:
• A multi-centre, retrospective, cross-sectional study to quantify the prevalence of MSF and assess variation in practice.
• A national survey of hand surgeons, disseminated electronically via national hand societies and research networks to establish equipoise and willingness to participate in a future RCT.
• A multi-centre, prospective cohort study conducted across five sites in the United Kingdom (UK) with collection of a range of clinical and patient reported outcome measures at 6weeks, 3 and 6months.
• A nested qualitative study consisting of patient interviews and focus groups, conducted on participants selected from the main study cohort using purposive sampling. Qualitative data was analysed using a thematic, inductive approach, as described by Braun and Clarke, consisting of a series of iterative stages.
• Microcosting methodology was used via direct observation of procedures to estimate the direct costs of surgical and non-surgical treatments by combining resource use with unit costs obtained from National Health Service (NHS) reference costs, NHS Agenda for Pay Scales, Personal Social Services Research Unit (PSSRU) Costs of Health and Social Care, and hospital finance departments. Indirect costs were calculated using the human capital approach.
• A factorial design randomised sub-study evaluating the effectiveness of different text message strategies (frequency, responsiveness and personalisation) in optimising data collection and participant retention.
Main findings
Based on 837,212 Emergency Department attendances at six participating centres, the incidence of MSF was 40 per 100,000 persons per year. Injury occurred most frequently in males aged 16-34years. A unimodal distribution is noted in men with a peak incidence at 16-24years, whereas frequency distribution in women was fairly uniform across the ages.
There is no agreement amongst clinicians on acceptable deformity in MSF, with variation in angulation, shortening and indications for surgical intervention. Furthermore, a variety of different surgical and non-surgical interventions are used throughout the UK with considerable heterogeneity in treatments, rehabilitation, and outpatient follow-up. Fracture displacement and complexity were the only characteristics associated with treatment modality.
One hundred and eight participants were recruited to the main cohort study from five sites. Adherence to follow-up declined throughout the study, 45% completed all study datapoints. Minimal clinically important difference (MCID) values are presented for the Hand Health profile of the Patient Evaluation Measure (PEM), Shortened Disabilities of the Arm, Shoulder and Hand Outcome Measure (QuickDASH), Patient-Reported Outcomes Measurement Information System Upper Extremity (PROMIS-UE), and EQ-5D-5L index. The PEM, QuickDASH, and PROMIS-UE were the most responsive to change and demonstrated good sensitivity and specificity in appropriately identifying change within this patient population.
Twenty interviews were conducted with 13 participants. Three focus groups were conducted with eight participants attending each group. Five key themes and 30 sub-themes were identified. Analyses revealed functional limitations that impacted on domestic, employment, familial and social activities, and contributed to an impaired sense of self and identity particularly amongst younger participants. Participants reported a preference for the QuickDASH and PROMIS-UE over the PEM for measuring hand function and requested more frequent follow-up in the first 6weeks post-injury.
The direct and indirect costs of non-surgical and surgical treatment for MSF in adults were estimated as £1063.72 and £4087.02 respectively, with lost productivity constituting up to 62% of total costs.
Frequency of Short Message Service (SMS) messages, responsiveness, and personalisation were not associated with improved participant retention or data collection in the current study.
Conclusion
This thesis demonstrates that many aspects of a multicentre RCT comparing surgical and non-surgical treatment for MSF in adults are feasible and provides valuable information to inform its design and conduct by: (a) demonstrating feasibility of recruitment across multiple UK sites, (b) identifying appropriate outcome measures for use in a future trial, (c) providing MCID values for the candidate primary outcome measures to guide future sample size calculations, (d) estimating costs of treatments to guide future cost-effectiveness analyses, and (e) exploring means to optimise engagement and participation of MSF patients in clinical studies. It also provides personalised and contextualised insight about participants’ experience of MSF and views on trial conduct and acceptability. However, despite the exploration of views on randomisation and equipoise in qualitative discussions, the feasibility of randomisation was not established due to the observational design and requires further exploration in future studies.
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