False Alarms and Pseudo-Epidemics: The Limitations of Observational Epidemiology

Grimes, David A.; Schulz, Kenneth F.

doi:10.1097/aog.0b013e31826af61a

Cited by 254Statistical Methods in EpidemiologyMeta-analysis and systematic reviewsAdvanced Causal Inference Techniques

False Alarms and Pseudo-Epidemics: The Limitations of Observational Epidemiology

Grimes, David A., Schulz, Kenneth F.·2012·Obstetrics & Gynecology

DOI 10.1097/aog.0b013e31826af61a

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Abstract

Most reported associations in observational clinical research are false, and the minority of associations that are true are often exaggerated. This credibility problem has many causes, including the failure of authors, reviewers, and editors to recognize the inherent limitations of these studies. This issue is especially problematic for weak associations, variably defined as relative risks (RRs) or odds ratios (ORs) less than 4. Such associations, commonly reported in the medical literature, are more likely to be attributable to bias than to causal association. All observational research has bias (which can include selection, information, and confounding bias). Hence, detection of small associations falls below the discriminatory ability of observational studies. In general, unless RRs in cohort studies exceed 2 to 3 or ORs in case-control studies exceed 3 or 4, associations in observational research findings should not be considered credible. However, these guidelines are not foolproof: strong (yet spurious) associations can result when large amounts of bias are present. Only in a properly performed randomized controlled trial, free of bias, should small associations merit attention. Better training and more circumspection on the part of investigators, tougher editorial standards on the part of journals, and hefty skepticism on the part of referees and readers are necessary to avoid the dangers of false alarms, pseudo-epidemics, and their unfortunate consequences.

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Following Grimes and Schultz, odds ratios were considered clinically significant only if greater than 3.5 or 4.
“In accordance with recommendations of Grimes and Schultz (23), we considered odds ratios to be clinically significant only if they were greater than 3.5 or 4.”
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Authors: Grimes, D. A., & Schulz, K. F.
Affiliations: University of North Carolina at Chapel Hill (US)
ORCID: Grimes, David A.
Schulz, Kenneth F.
Venue: Obstetrics & Gynecology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2012-10
Volume: 120
Issue: 4
Pages: 920-927
ISSN: 0029-7844 (ISSN-L)
DOI: 10.1097/aog.0b013e31826af61a
OpenAlex: W2130635109
Cited by: 254
References: 70
Citations by year: 2026: 5 · 2025: 13 · 2024: 14 · 2023: 13 · 2022: 17 · 2021: 23 · 2020: 27 · 2019: 18 · 2018: 30 · 2017: 19 · 2016: 18 · 2015: 25 · 2014: 19 · 2013: 10 · 2012: 2
FWCI: 17.14
Type: journal article
Language: en
Open access: closed
Locations: Obstetrics and Gynecology (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Keywords: false alarms, weak associations, spurious association, bias in observational studies, confounding, selection bias, information bias, relative risk, odds ratio, editorial standards, peer review, randomized controlled trials
MeSH terms: Data Interpretation, Statistical, Risk, Reproducibility of Results, Cohort Studies, Bias, Causality, Odds Ratio, Case-Control Studies, Observation

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False Alarms and Pseudo-Epidemics: The Limitations of Observational Epidemiology

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