Evidence mapPaperPMID 29020193Full record

Trial reportAmerican journal of epidemiology2018

Generalizing Randomized Clinical Trial Results: Implementation and Challenges Related to Missing Data in the Target Population.

Jin-Liern Hong, Michele Jonsson Funk, Robert LoCasale, Sara E Dempster, Stephen R Cole, Michael Webster-Clark, Jessie K Edwards, Til Stürmer

Abstract readRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Addressing Systematic Missing Data in the Context of Causally Interpretable Meta-analysis.Prevention science : the official journal of the Society for Prevention Research · 2023
    Pooled it
  2. Causally Interpretable Meta-analysis: Application in Adolescent HIV Prevention.Prevention science : the official journal of the Society for Prevention Research · 2022
    Pooled it
  3. Pooled it
  4. Trial
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  10. Review
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  15. An outcome model approach to transporting a randomized controlled trial results to a target population.Journal of the American Medical Informatics Association : JAMIA · 2019
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jin-Liern HongDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Michele Jonsson FunkDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Robert LoCasaleMedical Evidence and Observational Research, AstraZeneca Pharmaceuticals, Gaithersburg, Maryland.
Sara E DempsterR&D Information, AstraZeneca Pharmaceuticals, Waltham, Massachusetts.
Stephen R ColeDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Michael Webster-ClarkDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Jessie K EdwardsDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Til StürmerDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Funding

UNC Center for AIDS Research Core F BiostatisticsP30AI050410 · UNIV OF NORTH CAROLINA CHAPEL HILL · 2001 to 2025
$10.9M
CFAR Network of Integrated Clinical Systems (CNICS)R24AI067039 · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2025 to 2025
$6.4M
Propensity scores and preventive drug use in the elderlyR01AG056479 · UNIV OF NORTH CAROLINA CHAPEL HILL · 2025 to 2025
$558k
Propensity Scores and Preventive Drug Use in the ElderlyR01AG023178 · BRIGHAM AND WOMEN'S HOSPITAL · 2005 to 2005
$309k
Comparative effectiveness of tailored HIV treatment plans and mortalityK01AI125087 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Jessie Edwards · 2021 to 2021
$95k
NCI NIH HHS R01 CA174453NHLBI NIH HHS R01 HL118255NIAID NIH HHS K01 AI125087NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI100654NIAID NIH HHS R24 AI067039NIAID NIH HHS U01 AI103390NIA NIH HHS R01 AG023178NIA NIH HHS R01 AG056479NIA NIH HHS R56 AG023178NICHD NIH HHS DP2 HD084070NICHD NIH HHS R21 HD080214NIMHD NIH HHS R01 MD011680
6 · The paper itself

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.

Indexed as

Data Interpretation, StatisticalEpidemiologic Research DesignAgedCardiovascular DiseasesCholesterol, LDLC-Reactive ProteinFemaleHumansMaleMiddle AgedRisk FactorsRosuvastatin CalciumUnited KingdomCholesterol, LDLC-Reactive ProteinRosuvastatin Calcium

Identifiers

PMID29020193
PMCPMC5888945

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

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.