Cited by 1,299Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsStatistical Methods in Epidemiology

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Do multiple outcome measures require p-value adjustment?

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Feise, Ronald J·2002·BMC Medical Research Methodology

DOI 10.1186/1471-2288-2-8PMC PMC117123

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Abstract

BACKGROUND: Readers may question the interpretation of findings in clinical trials when multiple outcome measures are used without adjustment of the p-value. This question arises because of the increased risk of Type I errors (findings of false "significance") when multiple simultaneous hypotheses are tested at set p-values. The primary aim of this study was to estimate the need to make appropriate p-value adjustments in clinical trials to compensate for a possible increased risk in committing Type I errors when multiple outcome measures are used. DISCUSSION: The classicists believe that the chance of finding at least one test statistically significant due to chance and incorrectly declaring a difference increases as the number of comparisons increases. The rationalists have the following objections to that theory: 1) P-value adjustments are calculated based on how many tests are to be considered, and that number has been defined arbitrarily and variably; 2) P-value adjustments reduce the chance of making type I errors, but they increase the chance of making type II errors or needing to increase the sample size. SUMMARY: Readers should balance a study's statistical significance with the magnitude of effect, the quality of the study and with findings from other studies. Researchers facing multiple outcome measures might want to either select a primary outcome measure or use a global assessment measure, rather than adjusting the p-value.

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Authors: Feise, R. J.
Corresponding author: Feise, Ronald J
ORCID: Feise, Ronald J
Venue: BMC Medical Research Methodology
Publisher: Springer Science and Business Media LLC
Published: 2002-06-17
Volume: 2
Issue: 1
Pages: 8-8
ISSN: 1471-2288 (ISSN-L)
DOI: 10.1186/1471-2288-2-8
PMC: PMC117123
OpenAlex: W2139498473
Cited by: 1,299
References: 42
Citations by year: 2026: 55 · 2025: 67 · 2024: 75 · 2023: 101 · 2022: 79 · 2021: 133 · 2020: 95 · 2019: 115 · 2018: 83 · 2017: 98 · 2016: 72 · 2015: 45 · 2014: 47 · 2013: 33 · 2012: 32
FWCI: 5.75
Type: journal article
Language: en
Open access: gold
doi.org
Licence: www.springer.com/tdm (unspecified)
Locations: BMC Medical Research Methodology (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion, other-oa)
PubMed Central (publishedVersion, other-oa)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords: p-value adjustment, type I error, multiple comparisons, clinical trials, primary outcomes, statistical significance, sample size
MeSH terms: Clinical Trials as Topic, Data Interpretation, Statistical, Humans, Confidence Intervals, Treatment Outcome

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