Journal
STATISTICS IN MEDICINE
Volume 35, Issue 7, Pages 966-977Publisher
WILEY
DOI: 10.1002/sim.6739
Keywords
personalised medicine; random effects; n-of-1 trials; cross-over trials; components of variation
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Various sources of variation in observed response in clinical trials and clinical practice are considered, and ways in which the corresponding components of variation might be estimated are discussed. Although the issues have been generally well-covered in the statistical literature, they seem to be poorly understood in the medical literature and even the statistical literature occasionally shows some confusion. To increase understanding and communication, some simple graphical approaches to illustrating issues are proposed. It is also suggested that reducing variation in medical practice might make as big a contribution to improving health outcome as personalising its delivery according to the patient. It is concluded that the common belief that there is a strong personal element in response to treatment is not based on sound statistical evidence. (C) 2015 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.
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