Research
The anatomy of an awesome randomised trial Ben A Marson and Daniel C Perry
Ben Marson is an Orthopaedic Registrar from the East Midlands North rotation who is currently out of programme and studying for a PhD at the University of Nottingham. He has been awarded a NIHR Doctoral Fellowship to investigate outcomes following childhood fractures.
Daniel Perry is a Professor of Orthopaedic Surgery and Honorary Consultant Orthopaedic Surgeon at Alder Hey Children’s Hospital. He is the chief investigator for several multicentre clinical trials of orthopaedic interventions including FORCE, SCIENCE and CRAFFT which have been funded by the NIHR. Dan is one of the three BOA Surgical Specialty Leads for Clinical Trials. 32 | JTO | Volume 09 | Issue 01 | March 2021 | boa.ac.uk
In the past decade, orthopaedics has emerged as an academic speciality able to deliver high-quality randomised trials. We are experiencing an explosion of engagement in research trials from both within our speciality and from external sources including research funders. This has resulted in the publication of many trials, including many in the top medical journals1-7. However, there remain many uncertainties within our speciality that need proper investigation.
R
andomised trials are the gold standard to compare healthcare interventions. However, conducting randomised trials is expensive, with major trials typically costing in excess of £1million8. The cost of these is accrued through the rigour in design and conduct of these studies – to ensure that the trial is a definitive answer to a question, and ultimately to avoid the dreaded conclusion that “more evidence is required”. As a community, we need to continue to ask clinical questions that can be answered through trials to continue to advance our understanding of the interventions we recommend. The purpose of this article is to unpick some of the features that convert these clinical questions into a trial that can be delivered for the benefit of our patients. This process starts when the clinical question is translated into a research question that underpins the clinical trial.
Where to start: the clinical question There are several sources of questions abundant in orthopaedic clinical practice. There are so many questions and uncertainties that the issue is more where to start? The panacea of a research question is to identify an issue with broad relevance. The question needs to be important to: 1) you, as you need to invest your own passion and energy into it; 2) your subspeciality colleagues, as you need their buy-in to deliver the study, and eventually to ensure your research findings have meaningful impact; 3) patients, who will be part of the study; 4) funding bodies to support the trial; 5) the public, who will ultimately benefit from the trial and 6) policy makers who use the research findings to shape commissioning decisions.
“The Gold Standard in research priority setting is the James Lind Alliance Priority Setting Partnership. This is based on a collaborative methodology to encourage meaningful engagement between researchers, clinicians and patients in setting research priorities.”
The need for research can be established through systematic reviews. Cochrane reviews highlight needs for future research,
