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Project title- MALIT- Mallet Injuries Trial
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Grant Holder:
James Henderson, Abhilash Jain
Position:
JH-
Consultant Plastic & Hand Surgeon
Honorary Senior Lecturer
University of Bristol
AJ-
Associate Professor Plastic and Hand Surgery
University of Oxford and Imperial College NHS Trust London
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Date of award
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May 2015
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Date of report
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March 2017
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Grant Awarded (i.e. £10,000)
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£11,500
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Is this an interim, or final, report
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Interim
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Summary of progress /findings (approx 300 words)
This has been preliminary work to inform the design of a main trial in mallet injury splinting. We sought to answer the question “what is the optimum duration of splintage for a mallet injury”. We recognised that there was a huge paucity of information about this very common injury, despite a Cochrane review in 2008.
Significant support was provided by Professor Jane Blazeby and the Bristol Surgical Trials Unit team, who gave expert input on trial and survey design, and a successful working party group was established.
The BSSH grant allowed us to employ a postdoctoral research assistant, Dr Zoe Tolkein, who has completed a systematic review of orthotic splint compliance. We have conducted and analysed a national survey of management practise and opinions on important outcome measures, and both these pieces of work have been submitted for publication. Further papers are pending. We have given multiple presentations of the work at national and international meetings.
The findings of the preliminary work have shown that the vast majority of patients in the UK are splinted for either six or eight weeks. Splint types and outcome measures are varied and inconsistent across the literature and clinical practice in the UK.
We concluded that a randomised controlled trial of splint duration between six and eight weeks would not be significantly meaningful to the clinicians and patients in the NHS, and the trial was unlikely to attract the necessary funding for a large-scale multicentre RCT. We are now looking at alternative study designs including a prospective audit.
The findings of the review of splint adherence were very interesting, and have given many ideas for future avenues of work into adherence with splintage, which is an important area of clinical practice with very little research conducted into it to date.
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What is the relevance/value of this research to hand surgery
It was astonishing that there is so little evidence about best management, assessment of compliance, or even what the appropriate outcome measures ought to be for such a common hand injury. We collated some important data that will be useful for any future trial design in mallet injury. We have also made some interesting and unexpected progress into the assessment of adherence. We are now looking at ways to build on these findings both for mallet injury, and the wider assessment of splint adherence, which is critical to many areas of hand surgery.
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If final report, please provide bullet point list of conclusions/important findings
We plan to update this report once we have published the papers above, and to update the BSSH about our on-going work.
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Please list presentations based on work performed in this study
BAPRAS meeting 26th November 2016 – presentation “Variation in the management of Mallet finger in the UK: A survey of national practice”
BSSH April 2016 – poster “Feasibility work to inform a main RCT in mallet injury”
BSSH October 2016 – poster “Variation in the management of Mallet finger in the UK: A survey of national practice”
International Clinical Trials Methodology Conference May 2017 – presentation “Understanding methods for the assessment of patient adherence: a case study in removable devices for the improvement of trial outcome data”
North Bristol Trust Audit Day March 2016 – presentation “MALIT: Mallet Injury
Splinting Trial”
Royal College of Surgeons Systematic Review Workshop May 2016 – presentation “Assessment of patient adherence to removable orthoses: A systematic review”
Royal College of Surgeons Systematic Review Workshop October 2016 – presentation “Assessment of patient adherence to removable orthoses: A systematic review”
RSTN Trials Day – presentation “MALIT – splinting for mallet injuries: Results of a national clinician survey”
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Please list publications based on work performed in this study
Submitted:
To JPRAS: Conservative management of mallet injuries: A national survey of current practice in the UK. Z Tolkien, S Potter, N Burr, M D Gardiner, J M Blazeby, A Jain, J Henderson.
To PLoS One: Understanding methods to assess patient adherence: a systematic review in removable orthoses for the improvement of trial conduct. Zoe Tolkien, Shelley Potter, Dan Yeomans, Irene A. Kreis, Matthew D. Gardiner, Abhilash Jain, James Henderson, Jane M Blazeby.
Pending:
To JHS (Am) – “Don’t leave your RCT to chance”. How preliminary work informs a main trial with lessons learned from the MALIT trial.
Systematic review of the treatment of mallet injuries in progress.
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Please state what additional research this study has/is leading to
We are exploring trial design for a study to assess the management of mallet injuries- our preliminary work has highlighted questions about optimum splint type, duration of splintage, subsequent management and assessment of outcomes. We are also looking at novel ways to assess adherence with splinting.
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Please list any further funding or grant applications (with outcome), which have resulted from the award of this grant
Professor Jane Blazeby and the Bristol Surgical Trials unit agreed to support the work and have provided significant expertise free of charge.
We were also awarded:
BAPRAS research grant- Awarded £11,500 (2015)
RCS systematic review support- ongoing practical support from the RCS SR unit.
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How has this grant awards helped your career development?
JH-
I have been very lucky to work with Jane Blazeby, Professor of Surgery at the Bristol Surgical Trials Unit, and the Surgical Trials team.
I have learned a huge amount about trial design, systematic reviews, and the role of pre-trial work, and built very useful contacts for ongoing work, as detailed above.
I hope that once this work is completed, I will be able to work with Jane and her team again to develop a successful application for a large grant to fund a multicentre RCT in hand surgery.
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