More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk

Robert P McMahon; Stephan Arndt; Robert R Conley

doi:10.1002/sim.1837

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More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk

Journal article

Peer reviewed

More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk

Robert P McMahon, Stephan Arndt and Robert R Conley

Statistics in medicine, Vol.24(1), pp.11-21

01/15/2005

DOI: 10.1002/sim.1837

PMID: 15515151

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Abstract

Common adverse effect measures in psychiatric trials are typically analysed with repeated measures ANOVA, despite having distributions which violate key assumptions of that method; moreover, some adverse effects may be concentrated in vulnerable subgroups of participants. For testing treatment differences in adverse effects, we propose use of Kendall's taub as a summary measure of within-participant trends in adverse events, in conjunction with a weighted modification of a rank test proposed by Conover and Salsburg. Data on extrapyramidal side effects from a controlled clinical trial conducted in persons with treatment resistant schizophrenia was used to compare the proposed analysis to repeated measures ANOVA using mixed models and alternate tests for treatment differences in taub trend scores.

Antipsychotic Agents - adverse effects

Antipsychotic Agents - therapeutic use

Basal Ganglia Diseases - chemically induced

Benzodiazepines - adverse effects

Benzodiazepines - therapeutic use

Chlorpromazine - adverse effects

Chlorpromazine - therapeutic use

Computer Simulation

Data Interpretation, Statistical

Double-Blind Method

Humans

Psychiatry - methods

Randomized Controlled Trials as Topic - methods

Schizophrenia - drug therapy

Details

Title: Subtitle: More powerful two-sample tests for differences in repeated measures of adverse effects in psychiatric trials when only some patients may be at risk
Creators: Robert P McMahon - University of Maryland, Baltimore
Stephan Arndt
Robert R Conley
Resource Type: Journal article
Publication Details: Statistics in medicine, Vol.24(1), pp.11-21
DOI: 10.1002/sim.1837
PMID: 15515151
NLM abbreviation: Stat Med
ISSN: 0277-6715
eISSN: 1097-0258
Grant note: 5 P30 MH40279 / NIMH NIH HHS 1R01 MH 47311 / NIMH NIH HHS
Language: English
Date published: 01/15/2005
Academic Unit: Psychiatry; Biostatistics; Nursing; Injury Prevention Research Center
Record Identifier: 9985132072002771

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