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To the Editor: In their Commentary, Dr Kraemer and colleagues¹ draw attention to the importance of moderators of treatment outcomes, the often unsatisfactory way these are dealt with (if at all) in randomized clinical trials (RCTs), and the potentially serious consequences of this neglect on patient care. They propose that every RCT should include a search for putative moderators of treatment outcome. Although acknowledging that positive results of such analyses rarely provide proof of the existence of these moderators, they stress that the importance resides in the hypotheses that the analyses generate. These hypotheses can then be tested in subsequent adequately powered and populated RCTs. However, it may take years to design, acquire adequate funding for, and execute such an RCT.

As an alternative, conducting N-of-1 trials² can be valuable to further investigate information on moderators of treatment outcome. As a hypothetical example, suppose an RCT had been conducted to . . . [Full Text of this Article]

Japp Deinum, MD, PhD
j.deinum@aig.umcn.nl

Gert Jan van der Wilt, PhD
University Medical Center St Radboud
Nijmegen, the Netherlands

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