A strategy to use soft data effectively in randomized controlled clinical trials
Abstract
Soft data are defined as measures having substantial intrasubject variability due to errors of measurement or to the inconsistency of subjects' responses. Such data are often important measures of response in randomized clinical trials. In this context, we show that using an intensive design and the slope of response on time as the outcome measure (a) maximizes sample retention and (b) decreases within-group variability, thus (c) maximizing the power of test procedures without requiring increased sample sizes.
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The method of calculating slopes and using the Wilcoxon signed-rank test is superior to ANOVAs for handling missing data.
“It has been demonstrated that this method is superior to ANOVAs for handling missing data (Kraemer & Thiemann, 1989).”
From Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder (2008) · cites this paper as Kraemer & Thiemann, 1989
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- Authors
- Kraemer, H. C., & Thiemann, S.
- Affiliations
- Stanford University (US)
- ORCID
- Kraemer, Helena C.
- Venue
- Journal of Consulting and Clinical Psychology
- Published
- 1989
- Volume
- 57
- Issue
- 1
- Pages
- 148-154
- ISSN
- 0022-006X (ISSN-L)
- 1939-2117
- OpenAlex
- W2057716301
- Cited by
- 100
- References
- 0
- Citations by year
- 2026: 1 · 2022: 1 · 2021: 1 · 2020: 3 · 2018: 2 · 2017: 1 · 2016: 1 · 2015: 1 · 2014: 2 · 2013: 4 · 2012: 2
- FWCI
- 4.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Consulting and Clinical Psychology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute of Mental Health (MH-30854)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
- Social Sciences › Decision Sciences › Management Science and Operations Research › Optimal Experimental Design Methods
- Keywords
- soft information, within-person variability, measurement error, sample retention, within-group variation, statistical power, sample size, randomized controlled trials
- MeSH terms
- Mental Disorders, Clinical Trials as Topic, Follow-Up Studies, Humans, Psychotherapy, Psychotropic Drugs, Random Allocation, Research Design
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