Is it possible to blind a trial for community-acquired pneumonia?
Blinding a randomized, controlled clinical trial provides benefits on several levels but often is not perfectly executed or well described. Most recent registration trials of therapy for community-acquired pneumonia were designed and conducted as blinded trials, although the descriptions of blinding were frequently incomplete. Issues related to definitions, conduct, testing success, and reporting of blinding are addressed in this article. The benefits of blinding clinical trial participants, study drug assignment, microbiological data, and outcome assessments of both efficacy and safety are presented. Particular attention is paid to challenges inherent in the blinding of trials of therapy for pneumonia, especially in trials involving seriously ill patients who require intravenous therapy.
Boucher
Helen W
HW
Division of Infectious Diseases, Tufts University Medical School and Tufts Medical Center, Boston, Massachusetts 02111, USA. hboucher@tufts-nemc.org
D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents