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Running (more!) randomised controlled trials in sport and exercise medicine – Tips for clinical research

6 Aug, 17 | by BJSM

Sport and Exercise Medicine: The UK trainee perspective  A BJSM blog series

By Dr Robert M Barker-Davies

Have you ever considered running a randomised control trial (RCT)? Or at least perhaps wondered why there aren’t more of them in sports medicine? RCTs along with systematic review and meta-analysis are the gold standard for evidence-based medicine. Just 3% of articles in the BJSM between 1991-1995 were RCTs, increasing to 7% from 1996-2000 compared to over 16% in the BMJ1. More recently across sports medicine literature, that figure has been reported as 6% by systematic review2.

Most readers will be familiar with how quickly autologous blood/platelet rich plasma injections rose to fame. Early on in the process of putting my PhD research proposal together, a PubMed search on this topic found 3 out of 62 papers to be RCTs. As the quality of the research improved, the justification for administering this treatment disappeared.

A challenge in sports medicine research is that most patients have a thirst for a winning new (medical) formula and they rarely want to be in the control group. Yet do we really adhere to the principle primum non nocere if we don’t have evidence for a new treatment? In the UK Military, we have a clear duty of care to our personnel that tips the balance away from the untried and untested.

The case of High Volume Injection

High Volume Image Guided Injection (HVIGI) has promise as an adjuvant therapy3. At Headley Court Rehabilitation Hospital, we appraised the evidence and decided to practice HVIGI within the framework of an RCT before rolling out its use more widely. With the support of the Higher Education Funding Council for England’s catalyst fund in collaboration with Loughborough University, the National Centre for Sport and Exercise Medicine and Defence Medical Services, I am now studying as a full time PhD student to run this project. This has meant taking 3 years out of SEM registrar training.

Running an RCT poses many challenges and requires a committed team. Processes such as blinding, randomisation, unblinding, safety reporting and data monitoring all require additional staff members outside of the traditional multidisciplinary team. Much of this relies on the good-natured professionalism of those involved.

Getting off to the right start is key to avoid later pitfalls and delays re-submitting applications for regulatory and ethical approval. Dr Ben Goldacre’s book, Bad Pharma, brings to life the all too common problems with clinical trials. The cornerstone of his text relates to publication bias and missing data both well illustrated by the case of TGN1412 in 2006. Six participants suffered multiple organ failure; all were possibly avoidable had the results of an unsuccessful trial 10 years earlier been made public4. A key recommendation here is that trials are registered. We have taken the additional step of publishing our High Volume injection protocol in a peer-reviewed journal5.

Once you have your funding, academic, institutional, ethical and regulatory approvals in place, comes the next challenge: recruitment. The excellent resources from the NIHR website highlight the danger of overestimating the ease with which you will recruit the study population6. Much of sports medicine is practiced away from a large institutional setting making this a constant challenge for the specialty. Pooling results in multi-centre trials is one way around this but presents organisational challenges.

Increasing engagement with research as part of SEM training perhaps offers us an opportunity here. Universal understanding makes collaboration easier. Good Clinical Practice (GCP) training is a short course covering the international governance standards for research. I would highly recommend Sports Medicine as a specialty engages with GCP’s language and processes to help bring the evidence we really need within our grasp.

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Robert Barker-Davies is Sport and Exercise Medicine (SEM) and Rehabilitation Medicine Registrar and Clinical Research Fellow with the Academic Department of Military Rehabilitation and Loughborough University. He joined the RAF on a medical cadetship whilst at the University of Nottingham in 2004, attained MRCGP in 2012 and served in the Falkland Islands, RAF Waddington and RAF Scampton as a station GP. He represented the RAF, Coventry Godiva Harries and Wales U23s as a sprinter and hurdler. He holds UK Athletics qualifications in coaching and has sought to bring together his knowledge of the sport with his professional training and experience. He commenced dual specialist training in Sport and Exercise Medicine and Rehabilitation Medicine at DMRC Headley Court in 2014.

Farrah Jawad is a Sport and Exercise Medicine Registrar and co-ordinates the BJSM Trainee Perspective blog.

References

  1. Bleakley C, MacAuley D. The quality of research in sports journals. British journal of sports medicine 2002;36(2):124-5.
  2. Harris JD, Cvetanovich G, Erickson BJ, et al. Current status of evidence-based sports medicine. Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association 2014;30(3):362-71. doi: 10.1016/j.arthro.2013.11.015
  3. Wheeler PC, Mahadevan D, Bhatt R, et al. A Comparison of Two Different High-Volume Image-Guided Injection Procedures for Patients With Chronic Noninsertional Achilles Tendinopathy: A Pragmatic Retrospective Cohort Study. The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons 2016 doi: 10.1053/j.jfas.2016.04.017
  4. Goldacre B. Bad Pharma. London, UK: Fourth Estate 2012.
  5. Barker-Davies RM, Nicol A, McCurdie I, et al. Study protocol: a double blind randomised control trial of high volume image guided injections in Achilles and patellar tendinopathy in a young active population. BMC musculoskeletal disorders 2017;18(1):204. doi: 10.1186/s12891-017-1564-7
  6. Research NIfH. Clinical Trials Guide for Trainees https://www.nihr.ac.uk/funding-and-support/documents/Clinical-Trials-Guide.pdf2017 [accessed 26 May 2017.

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