Trial reportAmerican journal of epidemiology2018
Generalizing Randomized Clinical Trial Results: Implementation and Challenges Related to Missing Data in the Target Population.
Trial report in American journal of epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 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
17 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Addressing Systematic Missing Data in the Context of Causally Interpretable Meta-analysis.Prevention science : the official journal of the Society for Prevention Research · 2023Pooled it
- Causally Interpretable Meta-analysis: Application in Adolescent HIV Prevention.Prevention science : the official journal of the Society for Prevention Research · 2022Pooled it
- Clinical Trial Generalizability Assessment in the Big Data Era: A Review.Clinical and translational science · 2020Pooled it
- Transporting the effect of the ASSIST school-based smoking prevention intervention to the Smoking, Drinking and Drug Use Among Young People in England Survey (2004-2021): A secondary analysis of a randomized controlled trial.Addiction (Abingdon, England) · 2025Trial
- Target Trial Emulation and Bias Through Missing Eligibility Data: An Application to a Study of Palivizumab for the Prevention of Hospitalization Due to Infant Respiratory Illness.American journal of epidemiology · 2023Trial
- Body mass index, calcium supplementation and risk of colorectal adenomas.International journal of cancer · 2019Trial
- Comparison of Methods to Generalize Randomized Clinical Trial Results Without Individual-Level Data for the Target Population.American journal of epidemiology · 2019Trial
- Generalizability of clinical trial efficacy results to a real-world population: An example in migraine prevention.Journal of managed care & specialty pharmacy · 2023Article
- Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice: Findings From EXTEND-CoreValve.JACC. Cardiovascular interventions · 2021Article
- The Impact of Excluding Nonrandomized Studies From Systematic Reviews in Rare Diseases: "The Example of Meta-Analyses Evaluating the Efficacy and Safety of Enzyme Replacement Therapy in Patients With Mucopolysaccharidosis".Frontiers in molecular biosciences · 2021Review
- Reweighting Randomized Controlled Trial Evidence to Better Reflect Real Life - A Case Study of the Innovative Medicines Initiative.Clinical pharmacology and therapeutics · 2020Article
- Target validity: Bringing treatment of external validity in line with internal validity.Current epidemiology reports · 2020Article
- A standardization approach to compare treatment safety and effectiveness outcomes between clinical trials and real-world populations in psoriasis.The British journal of dermatology · 2019Article
- Effect Estimates in Randomized Trials and Observational Studies: Comparing Apples With Apples.American journal of epidemiology · 2019Article
- An outcome model approach to transporting a randomized controlled trial results to a target population.Journal of the American Medical Informatics Association : JAMIA · 2019Article
- Cognitive Change After Cardiac Surgery Versus Cardiac Catheterization: A Population-Based Study.The Annals of thoracic surgery · 2019Article
- Diagnostic Assessment of Assumptions for External Validity: An Example Using Data in Metastatic Colorectal Cancer.Epidemiology (Cambridge, Mass.) · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
Statins are indicated in patients with elevated levels of high-sensitivity C-reactive protein and normal low-density lipoprotein cholesterol based on results of the multicountry trial, Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) (2003-2008), but the benefit in real-world populations remains unknown. We sought to generalize JUPITER results to trial-eligible population using data from the UK Clinical Practice Research Datalink (CPRD), 2001-2014. We multiply imputed missing baseline characteristics for the CPRD population and selected the trial-eligible participants as the target population based on observed and imputed values. Trial participants were weighted to be representative of the CPRD population (n = 383,418) based on individual predicted probability of selection into the trial. Trial participants were also standardized to the CPRD population without missing values (n = 2,677). In JUPITER, rosuvastatin reduced cardiovascular risk with a 3-year risk difference of -2.0% (95% confidence interval (CI): -2.9, -1.1). The rosuvastatin effect was muted in the first 2 years but remained strong at 3 years after standardizing to the imputed CPRD population (3-year risk difference = -2.7%; 95% CI: -5.8, 0.4) and the CPRD population without missing data (3-year risk difference = -1.7%; 95% CI: -3.5, 0.1). The study serves as an illustration of possible approaches to understanding generalizability of trials using real-world databases given limitations due to missing data on inclusion/exclusion criteria.
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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.