The DOI matches its Crossref record.
Data Checks Before Registering Study Protocols for Health Care Database Analyses
Abstract
This Viewpoint discusses the challenges involved with secondary health care data collection vs primary data collection and provides a list of suggested data checks before registration of a study protocol using secondary data.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The study protocols, design, and coding algorithms were aligned across all 3 databases and deposited in ClinicalTrials.gov before any inferential outcome analyses were started.
“The study protocols, design, and coding algorithms were aligned across all 3 databases and deposited in ClinicalTrials.gov (NCT06914102, NCT06914154, NCT06914141) before any inferential outcome analyses were started.17”
From Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction (2025) · cites this paper as [17]
The study design and analytic protocols were fully prespecified and publicly registered before outcome analyses, with comprehensive methods and code algorithms available to ensure transparency and reproducibility.
“Third, the study design and analytic protocols were fully prespecified and publicly registered before outcome analyses, with comprehensive methods and code algorithms available to ensure transparency and reproducibility.17”
From Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction (2025) · cites this paper as [17]
Citations
Cites
No references could be resolved yet.
Research works printed but not linked: 5
- Zarin, 2020, Issues in the registration of database studies., J Clin Epidemiol, 121, 29, 10.1016/j.jclinepi.2020.01.007 · DOI
- Orsini, 2020, Improving transparency to build trust in real-world secondary data studies for hypothesis testing—why, what, and how., Pharmacoepidemiol Drug Saf, 29, 1504, 10.1002/pds.v29.11 · DOI
- Franklin, 2020, Nonrandomized real-world evidence to support regulatory decision making., Clin Pharmacol Ther, 107, 817, 10.1002/cpt.v107.4 · DOI
- Wang, 2023, Emulation of randomized clinical trials with nonrandomized database analyses: results of 32 clinical trials., JAMA, 329, 1376, 10.1001/jama.2023.4221 · DOI · Paper page
- Wang, 2023, HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force., Pharmacoepidemiol Drug Saf, 32, 44, 10.1002/pds.v32.1 · DOI
Cited by
Sorted by citations
Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction
Krüger, N., Schneeweiss, S., Fuse, K., Matseyko, S., Sreedhara, S. K., Hahn, G., Schunkert, H., & Wang, S. V. (2025) · JAMA · doi:10.1001/jama.2025.14092 · Cited by 66
Self-citation
Metadata
- Authors
- Wang, S. V., & Schneeweiss, S.
- Affiliations
- Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2024-05-07
- Volume
- 331
- Issue
- 17
- Pages
- 1445
- ISSN
- 0098-7484
- Cited by
- 17
- References
- 0
- Language
- en
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
