ArticleJournal of the American Medical Informatics Association : JAMIA2020
Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable.
Article in Journal of the American Medical Informatics Association : JAMIA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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
10 citing papers in PubMed.
- Enhanced access to healthcare utilization data through medical record review: Lessons learned from a community-based, multi-site project.Research in nursing & health · 2021Trial
- Assessing Electronic Health Record-Derived Outcomes in a Pragmatic Weight Gain Prevention Trial: Effects, Variability, and Implications for Future Trials.The Journal of cardiovascular nursingTrial
- From Billing Codes to Breakthroughs: Filtering Signal From Noise in Electronic Medical Records-Based Research.The Journal of neuropsychiatry and clinical neurosciences · 2026Article
- Decentralized Clinical Trials in the Era of Real-World Evidence: A Statistical Perspective.Clinical and translational science · 2025Review
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.Contemporary clinical trials · 2025Article
- Strategies for working with pragmatic clinical trial observational data-lessons learned from the Pain Management Collaboratory.Pain medicine (Malden, Mass.) · 2024Article
- Framework of the strengths and challenges of clinically integrated trials: An expert panel report.American heart journal · 2024Review
- Program of All-Inclusive Care for the Elderly: an untapped setting for research to advance pain care in older persons.Frontiers in pain research (Lausanne, Switzerland) · 2024Article
- Can Electronic Health Records Validly Estimate the Effects of Health System Interventions Aimed at Controlling Body Weight?Obesity (Silver Spring, Md.) · 2020Article
- Applying patient-reported outcome methodology to capture patient-reported health data: Report from an NIH Collaboratory roundtable.Healthcare (Amsterdam, Netherlands) · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Pragmatic clinical trials often entail the use of electronic health record (EHR) and claims data, but bias and quality issues associated with these data can limit their fitness for research purposes particularly for study end points. Patient-reported health (PRH) data can be used to confirm or supplement EHR and claims data in pragmatic trials, but these data can bring their own biases. Moreover, PRH data can complicate analyses if they are discordant with other sources. Using experience in the design and conduct of multi-site pragmatic trials, we itemize the strengths and limitations of PRH data and identify situational criteria for determining when PRH data are appropriate or ideal to fill gaps in the evidence collected from EHRs. To provide guidance for the scientific rationale and appropriate use of patient-reported data in pragmatic clinical trials, we describe approaches for ascertaining and classifying study end points and addressing issues of incomplete data, data alignment, and concordance. We conclude by identifying areas that require more research.
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What OpenQuestion 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 OpenQuestion graph.