Contradiction of clinical practice by newer and more rigorous trials
Medical reversal refers to when a newer and methodologically superior clinical trial produces results that contradict existing clinical practice and the older trials on which it is based. This leads to an intervention that was widely used falling out of favor, because new evidence either demonstrates that it is ineffective or that its harms exceed its benefits. It is distinct from replacement, which occurs when a newly developed medical treatment supersedes an older, less effective one as the standard of care.[1] Medical reversals are caused when a treatment is widely adopted even when there is not compelling evidence for its safety and effectiveness. For example, an intervention may be adopted because it "makes sense", or because there are observational studies supporting its putative benefits.[2] The negative effects of such reversals include harm to patients who received the intervention when it was considered relatively safe and effective, as well as reducing public trust in medicine.[3]
The term, medical reversal, was coined in 2011 by Vinay Prasad, Victor Gall and Adam Cifu in a research letter published in the Archives of Internal Medicine (now JAMA Internal Medicine).[3]
The term evidence reversal has also been proposed to refer to the same concept as medical reversal, but with a broader scope, including other scientific disciplines in addition to medical science.[4]
The tomato effect is a parallel concern. But, instead of clinical trials producing a different result, it is about changes in theory or the current understanding of a disease.[5][6]
^Prasad V, Cifu A (December 2011). "Medical reversal: why we must raise the bar before adopting new technologies". Yale J Biol Med. 84 (4): 471–8. PMC 3238324. PMID 22180684.
^Cifu AS, Prasad VK (December 2015). "Medical Debates and Medical Reversal". J Gen Intern Med. 30 (12): 1729–30. doi:10.1007/s11606-015-3481-5. PMC 4636561. PMID 26224155.
^ abPrasad, Vinay (2011-10-10). "The Frequency of Medical Reversal". Archives of Internal Medicine. 171 (18): 1675–6. doi:10.1001/archinternmed.2011.295. ISSN 0003-9926. PMID 21747003.
^Sutton, Desirée; Qureshi, Riaz; Martin, Janet (February 2018). "Evidence reversal—when new evidence contradicts current claims: a systematic overview review of definitions and terms". Journal of Clinical Epidemiology. 94: 76–84. doi:10.1016/j.jclinepi.2017.10.004. PMID 29045807.
^Goodwin JS, Goodwin JM (May 1984). "The tomato effect. Rejection of highly efficacious therapies". JAMA. 251 (18): 2387–90. doi:10.1001/jama.1984.03340420053025. PMID 6368890.
^Hausenblas, Heather (18 August 2014). "Does Physical Activity Show Signs of a Tomato Effect?". U.S. News & World Report. Retrieved 15 November 2014.
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