4.5 Article

Dropouts in the AB/BA crossover design

Journal

STATISTICS IN MEDICINE
Volume 31, Issue 16, Pages 1675-1687

Publisher

WILEY
DOI: 10.1002/sim.4497

Keywords

crossover design; dropouts; intention to treat; inverse probability weighting; missing data

Funding

  1. Medical Research Council [G0902108] Funding Source: Medline
  2. Medical Research Council [G0902108] Funding Source: researchfish
  3. National Institute for Health Research [RMOFS 09-05] Funding Source: researchfish
  4. MRC [G0902108] Funding Source: UKRI

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Missing data arise in crossover trials, as they do in any form of clinical trial. Several papers have addressed the problems that missing data create, although almost all of these assume that the probability that a planned observation is missing does not depend on the value that would have been observed; that is, the data are missing at random (MAR). In many applications, this assumption is likely to be untenable; in which case, the data are missing not at random (MNAR). We investigate the effect on estimates of the treatment effect that assume data are MAR when data are actually MNAR. We also propose using the assumption of no carryover treatment effect, which is usually required for this design, to permit the estimation of a treatment effect when data are MNAR. The results are applied to a trial comparing two treatments for neuropathic pain and show that the estimate of treatment effect is sensitive to the assumption of MAR. Copyright (C) 2012 John Wiley & Sons, Ltd.

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