Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations
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Randomized controlled trials (RCTs) are regarded as the most reputable source of evidence. In some studies, factors beyond the intervention itself may contribute to the measured effect, an occurrence known as heterogeneity of treatment effect (HTE). If the RCT population differs from the real-world population on factors that induce HTE, the trials effect will not replicate. The RCTs eligibility criteria should identify the sub-population in which its evidence will replicate. However, the extent to which the eligibility criteria identify the appropriate population is unknown, which raises concerns for generalizability. We compared reported data from RCTs with real-world data from the electronic health records of a large, academic medical center that was curated according to RCT eligibility criteria. Our results show fundamental differences between the RCT population and our observational cohorts, which suggests that eligibility criteria may be insufficient for identifying the applicable real-world population in which RCT evidence will replicate.
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Randomized controlled trials for this topic have ethical quandaries and external validity issues because participants must relinquish autonomy of a reproductive organ to randomization, which limits their utility and appropriateness.
“Though randomized controlled trials (RCTs) exist, 19,25 ethical quandaries and external validity issues given that participants must relinquish autonomy of a reproductive organ to randomization places limits on utility and appropriateness of RCT evidence for this topic.31,32”
From Hysterectomy versus uterine preservation for pelvic organ prolapse surgery: a prospective cohort study (2025) · cites this paper as [31]
The Introduction (page not provided) says restrictive RCT eligibility criteria can limit external validity and make it unclear whether trial evidence is appropriate for a different real-world population. The paper does not address reproductive-organ autonomy or ethical concerns about randomization, and it does not assess RCTs for the citing document’s specific topic. (LLM, conf=0.88)
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- Authors
- Averitt, A. J., Weng, C., Ryan, P., & Perotte, A.
- Affiliations
- Columbia University (US)
- Corresponding author
- Perotte, Adler
- Venue
- npj Digital Medicine
- Published
- 2020-05-11
- Volume
- 3
- Issue
- 1
- Pages
- 67-67
- ISSN
- 2398-6352 (ISSN-L)
- PMC
- PMC7214444
- OpenAlex
- W3021472140
- Cited by
- 137
- References
- 41
- Citations by year
- 2026: 14 · 2025: 20 · 2024: 24 · 2023: 31 · 2022: 21 · 2021: 23 · 2020: 4
- FWCI
- 13.93
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- npj Digital Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- U.S. Department of Health & Human Services | NIH | U.S. National Library of Medicine (R01LM009886-10, T15LM007079)
- Janssen Pharmaceuticals (CU15-2317)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- eligibility criteria, treatment effect heterogeneity, generalizability, real-world data, electronic health records, randomized controlled trials, observational cohort, evidence-to-practice translation
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