On April 13th and 14th 2015, academics, clinicians, patients and policy makers gathered at the University of Oxford for one of the world’s premier Evidence Based Medicine (EBM) conferences. Fuelled by the concerning gap between clinical and evidence-based medicine, recently declared a ‘crisis’, debate at the 4th Evidence Live conference centered around the future of EBM.
Carl Heneghan’s opening ‘Dangerous ideas’ challenge perhaps best encapsulated the conference’s theme. Carl invited members of the audience to video or blog an idea to ‘shorten the gap of translating medical research into clinical practice’. Various ideas put forward include the mandatory publication of trial protocols once ethical approval has been obtained as well as testing treatments in open-label, randomised controlled trials continually through the National Health Service (NHS). ‘Dangerous ideas’ challenged participants to think critically and offer innovative ideas to improve EBM.
The call for implementation, as opposed to further academic research, was a novel concept raised. Undoubtedly, if academic findings fail to influence clinical practice or change policy then they are of limited benefit. Rather than blindly creating more scientific knowledge via expensive research, existing knowledge needs to be engrained into clinical practice and health policy. Ben Goldacre was a strong advocate for this approach. He urged academics to invest time and resources to ensure academic findings make real change to policy and patients.
The AllTrials campaign is a leading example of successful translation of academic knowledge into tangible benefit. Research identified widespread publication bias across academic literature. It is estimated that around 50% of all trials ever produced are unavailable(1). Clearly, this jeopardizes clinicians, patients and policy makers’ ability to make truly evidence based decisions. Initiatives such as Clinical Study Data Request and the Yale University Open Data Access (YODA) group have been established in response to the AllTrials campaign to make all data available. During Evidence Live, Sile Lane (Sense about Science) gave a nice reflection on the achievements of AllTrials and their future goals. Specifically, she reinforced Ben Goldacre’s message of ClinicalTrials.gov being a perfect medium to publish all trials, including trial protocols and extensive trial methodology. She also supported the notion that investment in implementation strategies is essential to make this a reality. Although there is still much work to do, it was fitting that the World Health Organization (WHO) statement on Public Disclosure of Clinical Trials results was published during the conference.
Trish Greenhalgh also supported the call for less research to be conducted. Professor Greenhalgh suggested in many instances good outcomes can be achieved by patient specific application of available literature, even in the absence of gold standard evidence. Reflecting on her recent experience as a patient, she explained her decision to use non-sterodial anti-inflammatory (NSAIDs) medications for pain relief post cervical spine fusion. After reviewing the available evidence, Professor Greenhalgh was aware of the varied incidence of postoperative complications from NSAIDs use (impaired bone healing and bleeding). The evidence base was far from ideal (specifically, Professor Greenhalgh noted a lack of high quality systematic review), however the risks were real, especially given post operative bleeding in her case could lead to airway compromise. After assessing her risk of complications as per the available literature and her personal relevant medical history (no comorbidities, young, prior NSAID use for fractures without complication), she took the pain medications without adverse effect. By adjusting the available evidence to her specific circumstances, Professor Greenhalgh was able to make an appropriate patient centered, evidence based decision in the absence of high quality trials or reviews. Through this example Professor Greenhalgh suggested that non-gold standard evidence is still relevant and useful for clinicians, particularly when individualized to a patient’s situation. She concluded, of which was echoed by others, that academic research is expensive to produce and available evidence should be completely exhausted before future investment is considered.
Aside from challenging presentations on the future of EBM, there were numerous talks that reinforced EBM’s core principles. Rod Jackson taught his graphic approach to epidemiology (GATE) tool. This resource, which is available online, is an easy-to-follow worksheet to facilitate accurate and efficient critical appraisal. This tool offers step-by-step graphics to help the user identify patient groups, interventions and outcomes studied within a trial and then guides users through assessment of a study’s methodological strength. Another key principle was emphasized during Paul Glasziou’s presentation. Paul taught of the importance of clinically reproducible methodology. The TOHP study ‘proved’ that a low salt diet reduced long-term cardiovascular events. Unfortunately, the intervention employed was complex and unable to be reproduced clinically. The intervention includes intensive individualized dietician input and almost daily patient food diaries. As a General Practitioner, Professor Glasziou could not facilitate this intervention for his patients and thus this trial was a good example of waste in research.
Evidence Live provided a thorough examination of EBM. Leaders suggest solidifying and utilising our available evidence and adopting a parsimonious approach to new research investment. It is also clear that patients must remain central to clinical, academic and policy decisions. Complimenting the vociferous debate surrounding the future of EBM were fantastic teachings of EBM’s fundamental principles. As a clinician and forthcoming Doctor of Philosophy (DPhil) student I learnt immense amounts. The three-day June 2016 meeting will provide another opportunity to reflect and continue to improve the application of EBM.
This blog was written buy Jack O’Sullivan, Junior doctor Monash Health, forthcoming Clarendon Scholar and Doctor of Philosophy (DPhil/PhD) student at the Nuffield Department of Primary Care Health Sciences,University of Oxford.