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Comment & Response
May 21, 2019

Need for Randomized Trials to Support Procedural Interventions

Author Affiliations
  • 1The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  • 2The Ottawa Hospital, Ottawa, Ontario, Canada
JAMA. 2019;321(19):1938. doi:10.1001/jama.2019.2036

To the Editor Dr Wallis and colleagues highlighted the many issues surrounding the testing and approval of procedures and devices,1 which include questions of ethics (values) and epistemology (knowledge) about the need for RCTs. Although RCTs are valuable in medical research, they are not always scientifically required or ethically permissible, so how should the need for an RCT to assess a procedure or device be determined? To help adjudicate when RCTs should be performed, we have proposed 3 universal conditions: demonstrated uncertainty (ie, nonredundancy), scientific plausibility of any treatment (ie, no known inferiority), and methodological rigor.2