Greg Atkinson
Issues in the determination of “responders” and “non-responders” in physiological research
Atkinson, Greg; Williamson, Philip; Batterham, Alan M
Authors
Philip Williamson
Alan M Batterham
Abstract
As a follow-up to our 2015 review, we cover more issues on the topic of “response heterogeneity”, which we define as clinically-important individual differences in the physiological responses to the same treatment or intervention that cannot be attributed to random within-subjects variability. We highlight various pitfalls with the common practice of counting the number of “responders”, “non-responders” and “adverse responders” in samples that have been given certain treatments/interventions for research purposes. We focus on the classical parallel-group randomised controlled trial (RCT) design and assume typical good practice in trial design.
We show that sample responder counts are biased because individuals differ in terms of pre-to-post within-subjects random variability in the study outcome(s) and not necessarily treatment response. Ironically, sample differences in responder counts may be explained wholly by sample differences in mean response, even if there is no response heterogeneity at all. Sample comparisons of responder counts also have relatively low statistical precision. These problems do not depend on how the response threshold has been selected, e.g. on the basis of a measurement error statistic, and are not rectified fully by the use of confidence intervals for individual responses in the sample.
Citation
Atkinson, G., Williamson, P., & Batterham, A. M. (2019). Issues in the determination of “responders” and “non-responders” in physiological research. Experimental Physiology, 104(8), 1215-1225. https://doi.org/10.1113/EP087712
Journal Article Type | Article |
---|---|
Acceptance Date | May 20, 2019 |
Online Publication Date | May 22, 2019 |
Publication Date | Aug 1, 2019 |
Deposit Date | May 22, 2019 |
Publicly Available Date | May 23, 2020 |
Print ISSN | 1469-445X |
Publisher | Wiley |
Peer Reviewed | Peer Reviewed |
Volume | 104 |
Issue | 8 |
Pages | 1215-1225 |
DOI | https://doi.org/10.1113/EP087712 |
Keywords | Response heterogeneity; Inter-individual differences; Standard deviation; Responders; Within-subject random variability |
Public URL | https://hull-repository.worktribe.com/output/1830183 |
Publisher URL | https://physoc.onlinelibrary.wiley.com/doi/full/10.1113/EP087712 |
Contract Date | May 22, 2019 |
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