Evidence based medicine is broken

Evidence based medicine is broken? As internist we don't think so, but... there is a real world

Roberto Nardi, MD, Internal Medicine, Bologna, Giovanni Scanelli, U.O.C. di Medicina Interna Ospedaliera - Azienda Ospedaliero Universitaria di Ferrara “Arcispedale Sant’Anna-Italy

Doctor Des Spence, just in "From the Frontline" section of this Journal, pointed out that Evidence Based Medicine (EBM) broke its original mission under the influence of the pharmaceutical industry, which has encouraged - more or less explicitly- a creeping disease mongering, resulting in over-diagnosis and overtreatment1 and consequently in waste of health care resources. In fact, we spent the last twenty years introducing instruments of good clinical guidelines, diagnostic and therapeutic clinical pathways, and EBM practices. But much work is still needed to bridge the gap between what we have to do and what actually happens. Before that, a few preliminary questions emerge: is EBM compatible with patients of the real world? Are we confident that the "statistically significant" differences of clinical trials, reported in selected patients, are actually really helpful to patients at the front of the daily bed-side clinical practice? Internal medicine (IM) patients are mostly elderly, with multiple complex co-morbidities, usually chronic. The complexity of these patients involves the intricate entanglement of two or more systems (e.g. body and disease, familial-social-economic and environmental status, coordination of care and therapies) and this requires comprehensive, multi-dimensional assessment2,3. Unfortunately, in a context of uncertainty and not evidence, the evidence of EBM is in many cases not well defined, not definitive and sometimes even contradictory, but the bedside decisions of the physician must be black or white. Uncertainty and decision-making in hospital IM patients require a wise clinical judgment competence, by a critical assessment of the results of clinical trials, both in terms of selection of included/excluded cases and methodology in considering the results, and not only from a mere statistical point of view. Our patients need a comprehensive assessment in order to define the highest priorities. In such way we believe that EBM has, in itself, some inherent limitations. In evaluating the results of randomized clinical trials, we need to consider not only their statistical significance of results, but also their clinical relevance, in accordance with the principle of Minimal Clinically Important Difference (MCID). In interpreting the results, we have to consider whether or not the MCID has been taken into account before applying to our therapeutic decisions the results of any trial, e.g. in the implementation of very expensive drugs, such as those for cancers4. We agree that clinical Research should focus on what we don’t know, mostly in the real world.

• Competing interests: We have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
• Provenance and peer review: not externally peer reviewed.
• mail addresses: nardidoc48@gmail.com; g.scanelli@ospfe.it

References

1. Spence D: Evidence-based medicine is broken. BMJ 2014：348：g22
2. Nardi R, Scanelli G, Corrao S, et al. Co-morbidity does not reflect complexity in internal medicine patients. Eur J Intern Med 2007; 18:359-68.
3. Nardi R,Berti F, Greco A, Scanelli G et al, Complexity in hospital internal medicine departments: what are we talking about?, Ital J Med 2013; 7 :142-155
4. Nardi R, Berti F, Fabbri LM, Di Pasquale G,Iori I et al, on behalf of the FADOI and their Friends in the Appropriate decision making Project Group (FFA-PG) in hospital Internal Medicine wards, Toward a sustainable and wise healthcare approach: potential contributions from hospital Internal Medicine Departments to reducing inappropriate medical spending, Ital J Med 2013; 7: 65-81