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Articles: JoAnne Robbins, Gary Gensler, Jacqueline Hind, Jeri A. Logemann, Anne S. Lindblad, Diane Brandt, Herbert Baum, David Lilienfeld, Steven Kosek, Donna Lundy, Karen Dikeman, Marta Kazandjian, Gary D. Gramigna, Susan McGarvey-Toler, and Patricia J. Miller Gardner Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence: A Randomized Trial Ann Intern Med 2008; 148: 509-518 [Abstract] [Full text] [PDF]

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Ethics of a control arm

Dimitri Drekonja   (28 May 2008)

Ethics of a control arm 28 May 2008
Dimitri Drekonja, MD University of Minnesota; Minneapolis VA Medical Center Send rapid response to journal: Re: Ethics of a control arm drek0002{at}umn.edu Dimitri Drekonja	The report by Robbins et al. (1) on interventions to reduce aspiration pneumonia strikes me as a well executed, thoroughly reported trial that suffers from a fatal flaw of not including a no-treatment control arm. It is mentioned several times in the introduction and discussion that the interventions studied are "untested" and that there is an "absence of efficacy data," which indicates that there is sufficient clinical equipose to justify the inclusion of a no-treatment control arm. These assertions also make one question the statement supporting the lack of such a group, that such an arm would be "unethical in the context of standard clinical care." I would argue that the exclusion of such a control group severely weakens the findings of this study, as we are unable to determine if the lower than expected rate of pneumonia observed in the study is due to the interventions (a finding that would be of clinical importance), or rather some other tmporally associated factor. Given the assertions that the interventions are of unproven efficacy, I am unclear as to how including a no-treatment control arm would be unethical. Indeed, one could argue that expending large amounts of energy, time, and funding, in order to produce a result that is severely limited by the lack of a control arm, is ethically questionable in its own right. 1- Robbins et al. Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence. Ann Intern Med. 2008;148:509-18. [PMID: 18378947] Conflict of Interest: None declared