Volume 176 - Issue 3
Ethics and evidence-based medicine
Authors: Simon R Tomlinson, Kerry J Breen, Malcolm H Parker, Chris B Del Mar, Paul P Glasziou, Lucie Rychetnik and and Stephen R Leeder
Med J Aust 2002; 176 (3): 137-139. || doi: 10.5694/j.1326-5377.2002.tb04330.x
Published online: 4 February 2002
Published online: 4 February 2002
To the Editor: In response to Leeder and Rychetnik's article,1 evidence-based medicine (EBM) also has significant potential to reduce the quality of patient care, with obvious ethical implications. I refer to two specific issues of concern.
The first relates to the increased expectation that clinicians, and especially trainees, not only understand the role of EBM in clinical practice, but actively contribute to its underlying database. Indeed, some of the professional colleges (eg, the Faculty of the Australian and New Zealand College of Anaesthetists) now include formal projects (which are often, but not necessarily, clinical trials) in their final assessment of trainees.2 This is leading to increasing numbers of poorly designed trials that are unlikely to make useful contributions to the clinical database. These commonly take two forms: studies which lack sufficient power to confirm the absence of a true difference between groups,3,4 or studies which use a placebo when effective therapeutic alternatives exist.5 Yet such studies are frequently published in reputable, peer-reviewed journals.6 Both of these types of studies are unethical, and both impact adversely on patient care.
Increasing the evidence base of clinical medicine is important, but our primary responsibility remains the maintenance of quality of care of all patients, especially those involved in clinical trials. Therefore, education of clinicians, and especially trainees, must emphasise the role and importance of statistics, epidemiology and study design in all areas of medicine to prevent unnecessary reductions in the quality of care of this subset of patients.
The second concern relates to the increase in "quality improvement" projects that are rarely submitted to ethics committees for approval. These activities also contribute to the evidence base, primarily at a local level, but patients are usually unaware that they are involved in these projects, and that these activities may have significant quality-of-care implications for them.
It is therefore important that internal hospital quality assurance activities undergo a similar level of scrutiny by ethics committees to that of clinical trials. Patients involved in any audit or project that has the potential to influence their care should be required to give informed consent. Only then can we reassure a patient that, while we are continually striving to improve the care we provide by developing the evidence base for clinical medicine, the care of each individual remains our primary concern.
Competing interests
None declared.
References
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- Australian and New Zealand College of Anaesthetists Review E11. Formal project: guidelines for completion of a formal project to be a requirement for the award of the diploma of FANZCA endorsed in Anaesthesia. Melbourne: Australian and New Zealand College of Anaesthetists, 1992. pgfId-1166136
- Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error, and sample size in the design and interpretation of the randomised controlled trial: survey of two sets of "negative" trials. In: Bailar JC, Mosteller F, editors. Medical uses of statistics. 2nd ed. Boston, Mass: NEJM Books, 1992: 357-373. pgfId-1166143
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- Leeder SR, Rychetnik L. Ethics and evidence-based medicine. Med J Aust 2001; 175: 161-164.