ArticleNPJ digital medicine2020
Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations.
Article in NPJ digital medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 78 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
78 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Systematic review of terminology, definitions, and eligibility criteria in trials of neonatal encephalopathy, hypoxic-ischemic encephalopathy, and perinatal asphyxia.Pediatric research · 2026Pooled it
- Lipid-Lowering Trials Are Not Representative of Patients Managed in Clinical Practice: A Systematic Review and Meta-Analysis of Exclusion Criteria.Journal of the American Heart Association · 2023Pooled it
- Adverse Effects of Angiotensin-Converting Enzyme Inhibitors in Humans: A Systematic Review and Meta-Analysis of 378 Randomized Controlled Trials.International journal of environmental research and public health · 2022Pooled it
- Bellmunt Risk Score as a Prognostic Tool in Metastatic Castration-Resistant Prostate Cancer Survival.JAMA network open · 2026Trial
- Implementation strategies for hospital-based probiotic administration in a stepped-wedge cluster randomized trial design for preventing hospital-acquired Clostridioides difficile infection.BMC health services research · 2023Trial
- Parental developmental screening with CARE: A pilot hybrid assessment and intervention with vulnerable families in Colombia.PloS one · 2023Trial
- Recruitment and enrollment of participants in an online diabetes self-management intervention in a virtual environment.Contemporary clinical trials · 2021Trial
- Investigating Potential Adverse Drug Reactions of Lisdexamfetamine Using Sequence Symmetry Analysis.Basic & clinical pharmacology & toxicology · 2026Article
- Effectiveness of Newly Initiated Tofacitinib and Biologic DMARDs in Patients with Rheumatoid Arthritis.Rheumatology and therapy · 2026Article
- From patient advocacy to patient-driven research: Building active partnerships beginning at the bench to reach the bedside.FEBS open bio · 2026Article
- Distinct Patterns of Mobility Recovery After Stroke Using Routine Clinical Data.medRxiv : the preprint server for health sciences · 2026Article
- Risk of fracture following androgen receptor pathway inhibitors in men with advanced prostate cancer.Journal of the National Cancer Institute · 2026Article
- Prevention of Severe Postoperative Pain after Breast Surgery Using Opioid-Sparing Analgesia with Intraoperative and Drain-Based Ropivacaine Infiltration: A Prospective Observational Study.Breast care (Basel, Switzerland) · 2026Article
- Real-World Cardiovascular Research Using the German IQVIA Disease Analyzer Database: Methods, Evidence, and Limitations (2000-2025).Journal of cardiovascular development and disease · 2026Review
- Real-world effectiveness of biologic therapies in severe asthma patients ineligible for phase 3 randomised controlled trials of biologics: an analysis from the UK Severe Asthma Registry.ERJ open research · 2026Article
- Effectiveness of Internet-Based Cognitive Behavioral Therapy for Depressive Symptoms During Pregnancy by Using Real-World Data: Retrospective Cohort Study.JMIR mHealth and uHealth · 2025Article
- Real-world perioperative outcomes of neoadjuvant chemoimmunotherapy in non-small cell lung cancer.JTCVS open · 2025Article
- A Sensitivity Analysis Framework Using the Proxy Pattern-Mixture Model for Generalization of Experimental Results.Statistics in medicine · 2025Article
- Remotely Delivered Cognitive Behavioral Therapy for Adults With an Eating Disorder: Retrospective Analysis of a Real-World Patient Sample.Journal of medical Internet research · 2025Observational
- Effect of pretreatment lab abnormalities on the time-to-treatment discontinuation and overall survival of metastatic breast cancer patients receiving CDK 4/6i, PI3Ki, and/or mTORi.Breast cancer research and treatment · 2025Article
18 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
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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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.