Is the evidence-based medicine movement counter-productive: are randomised controlled trials the best approach to establish evidence in complex healthcare situations?
Susan Jacups A B * and Clare Bradley A C DA
B
C
D
Abstract
In the modern era, evidence-based medicine (EBM) has been embraced as the best approach to practising medicine, providing clinicians with ‘objective’ evidence from clinical research. However, for presentations with complex pathophysiology or from complex social environments, sometimes there remains no evidence, and no amount of research will obtain it. Yet, health researchers continue to undertake randomised controlled trials (RCT) in complex environments, ignoring the risk that participants’ health may be compromised throughout the trial process. This paper examines the role of research that seeks to obtain evidence to support EBM. We provide examples of RCTs on ear disease in Aboriginal populations as a case-in-point. Decades of ear research have failed to yield statistically significant findings, demonstrating that when multiple factors are at play, study designs struggle to balance the known disease process drivers, let alone unknown drivers. This paper asks the reader to consider if the pursuit of research is likely to produce evidence in complex situations; or if perhaps RCTs should not be undertaken in these situations. Instead, clinicians could apply empirical evidence, tailoring treatments to individuals while taking into account the complexities of their life circumstances.References
2 National Health and Medical Research Council (NHMRC) additional levels of evidence and grades for recommendations for developers of guidelines. Sydney: Med J Aust; 2009 [cited 2023 Jan 17]. Available from: www.mja.com.au/sites/default/files/NHMRC.levels.of.evidence.2008-09.pdf
3 Keane M, Berg C. Evidence-based medicine: a predictably flawed paradigm. Trends in Anaesthesia and Critical Care 2016;9:49–52. Crossref
12 Leach AJ, Morris PS, Coates HL, Nelson S, O’Leary SJ, Richmond PC, et al. Otitis media guidelines for Australian Aboriginal and Torres Strait Islander children: summary of recommendations. Med J Aust. 2021 Mar;214(5):228–33. Available from: www.health.gov.au/sites/default/files/documents/2021/07/otitis-media-guidelines.pdf
14 Wigger C, Leach AJ, Beissbarth J, Oguoma V, Lennox R, Nelson S, et al. Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian Aboriginal children: study protocol for factorial design randomised controlled trial. BMC Pharmacol Toxicol. 2019;20(1):46. Crossref | PubMed
15 Wigger C. Preliminary clinical treatment outcomes of a randomised controlled trial using Betadine® ear wash and oral Bactrim® for chronic suppuratives otitis media in Aboriginal Children. Otitis Media Australia Conference (OMOZ) 2018. Darwin, Australia: Menzies School of Health Research; 2018. Abstract available from authors.
21 O’Brien K. Social cohesion and resilience in First Australian family and kinship networks. Journal of Family History 2017;42(4):440–51. Crossref
22 McRae-Williams E, Gerritsen R. Mutual incomprehension: the cross cultural domain of work in a remote Australian Aboriginal community. International Indigenous Policy Journal. 2010;1(2). Crossref
23 Closing the Gap Clearinghouse. Ear disease in Aboriginal and Torres Strait Islander children. Canberra: Australian Institute of Health and Welfare & Melbourne: Australian Institute of Family Studies; 2014 [cited 2023 Jan 17]. Available from: www.aihw.gov.au/getmedia/c68e6d27-05ea-4039-9d0b-a11eb609bacc/ctgc-rs35.pdf.aspx
24 Kong K, Cass A, Leach AJ, Morris PS, Kimber A, Su J-Y, et al. A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial. Trials. 2021;22(1):403. Crossref | PubMed
25 Morsels of Evidence. Evidence-based medicine for general practitioners. Levels of evidence. Australia: Morsels of Evidence: 2019 [cited 2023 Jan 17]. Available from: https://evidencebasedmedicine.com.au/?page_id=30