Correspondence about the article “Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia. The REMAP-CAP corticosteroid domain randomized clinical trial”
Abstract
Adaptive platform trials represent an elegant opportunity to test multiple interventions for the same disease, and the considerable work of the REMAP-CAP consortium to evaluate multiple promising treatments for community-acquired pneumonia (CAP) should be commended. However, the recent publication of the fixe-duration hydrocortisone domain [1] raises a few questions. First , due to the open-label nature of the trial, 23% of patients randomized to the standard-of-care group neverthe-less received corticosteroids for a median duration of 4 days. We agreed that it is unlikely that this breach of protocol could have alone reversed the result. However, the median duration of hydrocortisone treatment was only 5 days in the CAPE COD trial, which demonstrated a benefit of hydrocortisone administration [2]. A per-protocol analysis would usefully refine the mortality rate at day 90, according to the treatment received. Second , 658 patients were randomized in 101 centers across 18 countries. It is certainly desirable that patients included in a trial reflect the diversity of their countries’ healthcare systems and income levels. However, this can make it difficult to ensure that the standard-of-care was the same in both groups. Little is known about treatments other than corticosteroids,, with a possible imbalance between groups that may have been favored by the open-label nature of the trial. Third , on average, each center included 6.5 patients, but it is likely that a large number…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 658 participants or records.
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