Mousoulis, Christos
(2021)
Improving the evidence for effective care of hand fractures and joint injuries.
PhD thesis, University of Nottingham.
Abstract
Background: Hand fractures and injuries impact considerably on patients and society. Hand injuries were prioritised by the recent James Lind Association Priority Setting Partnership on Common Conditions Affecting the Hand and Wrist, as currently there is little evidence to guide management. Clinical practice is mainly based on expert opinion leading to inevitable variation in management. Randomised controlled trials (RCTs) on hand injuries are rare and often poorly reported.
Aims: The overall aim of the thesis is to improve the evidence-base around the management of hand fractures and joint injuries. This will be achieved by informing the development of future RCTs in hand injuries.
This PhD thesis includes four projects: (1) a scoping review of the literature to highlight current research gaps and to identify common weaknesses in the design and reporting of hand surgery trials; (2) a multi-centre prospective cohort study of surgical patients presenting with proximal and middle phalangeal fractures (intra- and extra-articular), proximal interphalangeal joint (PIPj) bony volar plate injuries, and mallet finger injuries; (3) a Minimal Clinically Important Difference (MCID) study of the Patient Evaluation Measure (PEM) questionnaire; and (4) a nested qualitative study to explore patients’ experiences of recovery and views about participating in hand surgery trials.
Scoping review: The aim of this study was to identify and assess all published randomised controlled clinical trials (RCTs) on treatment interventions for hand fractures and joint injuries. There were 78 published RCTs with trial interventions that were extremely heterogeneous, resulting in difficulty when trying to draw conclusions on the effectiveness and side-effects of individual treatments.
Conclusion: The published RCT evidence for hand fractures and joint injuries is narrow in scope and of generally low methodological quality. There is a need for high-quality, collaborative research.
Cohort study: Consecutive patients were recruited from fracture clinics in Nottingham and Cardiff (24/05/19 to 24/02/20) and asked to complete Patient Reported Outcome Measure (PROM) questionnaires. These were the PEM, the Patient-Reported Outcomes Measurement Information System Computerised Adaptive Test (PROMIS CAT) and EuroQol 5 dimensions (EQ-5D-5L) at baseline and then at 6, 12, and 24 weeks following presentation. Improvements in symptoms, function and quality of life were observed over the 6 months of follow-up, but patients’ ratings generally did not return to pre-injury levels at 6 months. The PEM questionnaire was the most sensitive to change.
Conclusion: PEM is suitable for use as the primary outcome measure in trials, showing good sensitivity to change. Participants should be followed up for a minimum of 3 months, but might need follow-up for much longer as treatment response can be slow and was found to be still ongoing at 6 months in this study.
Minimal Clinically Important Difference (MCID) study: The aim of this study was to calculate the MCID of the PEM (range 11-77, lower score is better) at 24 weeks in order to inform the development and interpretation of future trials. The MCID for the PEM at 24 weeks was between 12-17 depending on the calculation method used. The MCID values were broadly consistent at different time points. The Minimal Detectable Change (MDC) was estimated to be 10.7 points.
Conclusion: The MCID calculations of the PEM will help in sample size calculations for future trials.
Qualitative study: Semi-structured interviews were conducted in 19 participants who were part of the cohort study. Though finger injuries were frequently seen as minor by the participants, their effects on them are greater than first anticipated. Experience of treatment and recovery varies significantly and is shaped by each patient’s age, job, lifestyle and hobbies. Interviewees stated reluctance to accept randomisation in surgical trials, particularly if surgical and non-surgical interventions were to be compared. This was because they had a treatment preference and/or felt that there was a better treatment for their individual injury that the surgeon should know about.
Conclusion: People often coped by normalising the effect of these injuries by downplaying their effects in order to return to their daily lives. Because patients view their injury as minor, they may be reluctant to take part in research. If the clinicians inform the patients that their injury can have major consequences, then patients might be more inclined to want to take part in research. Clinical equipoise and communication from researchers and the clinical team are essential to improve recruitment and retention.
Conclusions: Good quality RCTs for hand fractures are needed. The insight from this PhD project can help to plan future RCTs in this area.
| Item Type: |
Thesis (University of Nottingham only)
(PhD)
|
| Supervisors: |
Karantana, Alexia
Thomas, Kim
Leighton, Paul
Trickett, Ryan |
| Keywords: |
hand fractures, joint injuries, cohort study, scoping review, qualitative study, interviews, MCID |
| Subjects: |
W Medicine and related subjects (NLM Classification) > WE Muscoskeletal system |
| Faculties/Schools: |
UK Campuses > Faculty of Medicine and Health Sciences > School of Medicine |
| Item ID: |
66062 |
| Depositing User: |
Mousoulis, Christos
|
| Date Deposited: |
18 Mar 2022 11:18 |
| Last Modified: |
08 Aug 2023 04:30 |
| URI: |
https://eprints.nottingham.ac.uk/id/eprint/66062 |
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