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Editor's Note
July 8, 2019

Clinical Trial Evidence for the Real World

Author Affiliations
  • 1Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 2Department of Geriatrics, University of California, San Francisco
JAMA Intern Med. 2019;179(10):1333-1334. doi:10.1001/jamainternmed.2019.1500

It has been repeatedly demonstrated that participants in randomized clinical trials (RCTs) do not look like the patients we treat in our clinical practices. The inclusion and exclusion criteria of most RCTs exclude older adults and those with more severe disease, as well as those with conditions such as renal disease, liver disease, and cancer. The article by Smyth et al1 in this issue of JAMA Internal Medicine raises 2 noteworthy considerations. First, the study starkly contrasts the population of patients enrolled in RCTs with those in the real world who are undergoing dialysis. After systematically reviewing the literature, not only do Smyth et al1 show that RCT participants were significantly younger, more likely to be male, and less likely to have diabetes or diabetic nephropathy when compared with the patients undergoing dialysis in the United States Renal Data System registry, but they show that their mortality risk is less than half than that of the registry patients. This finding has particular importance because patients undergoing dialysis often underestimate their disease prognosis, both because of uncertainty as well as optimism, as shown in another article in this issue of JAMA Internal Medicine by O’Hare et al.2

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