Status: Planned
First registered on:
29/06/2017
Last updated on:
06/01/2023
1. Study identification
EU PAS Register NumberEUPAS19636
Official titleReproducible Evidence: Practices to Enhance and Achieve Transparency
Study title acronymREPEAT
Study typeObservational study
Brief description of the studyLarge healthcare database research informs both clinical and payment decisions as well as improves the quality and affordability of healthcare for public health. Interest and capacity to use data contained in large healthcare databases has increased exponentially, however, much of the evidence from those valuable large healthcare databases suffers from lack of reproducibility, transparency and scientific robustness. This project aims to evaluate the current state of reproducibility of large published healthcare database studies. We will achieve this objective by taking a systematic random sample of healthcare database studies published in a leading clinical or epidemiology journal within the last 5 years and attempting to reproduce them based on the reported methods in publications and appendices. We plan to sample studies that were conducted using different large healthcare data sources.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameN/A
Centre locationN/A
Details of (Primary) lead investigator
Title Dr
Last name Wang
First name Shirley
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/08/2017
Start date of data collection01/08/2017
Start date of data analysis01/08/2018
Date of interim report, if expected
Date of final study report01/01/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesLaura and John Arnold Foundation90
Government body
Research councils
EU funding scheme
OtherBrigham and Women's Hospital10
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wang
First name Shirley
Address line 11 Brigham Circle
Address line 2Suite 3030
Address line 3
CityBoston, MA
Postcode02120
CountryUnited States
Phone number (incl. country code)1-6175258376
Alternative phone number
Fax number (incl. country code)1-6172328602
Public Enquiries
Title Dr
Last name Wang
First name Shirley
Address line 11 Brigham Circle
Address line 2Suite 3030
Address line 3
CityBoston, MA
Postcode02120
CountryUnited States
Phone number (incl. country code)1-6175258376
Alternative phone number
Fax number (incl. country code)1-6172328602
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Pregnant women
9. Number of subjects
Estimated total number of subjects250
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
Medicare, United States
Medicaid, United States
Truven, United States
United, United States
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Pharmacy dispensing records
11. Scope of the study
What is the scope of the study?
Methodological
Primary scope : Methodological
12. Main objective(s)
What is the main objective of the study?
Our objective is to measure the current state of reproducibility for database research and empirically validate specific guidance/recommendations on what to report in order to achieve consistently reproducible and robust findings from healthcare database studies.
Are there primary outcomes?Yes
The primary outcomes for each replicated study will be the primary outcomes reported in the original paper.
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Drug utilisation study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Duration of follow up in replicated studies will be defined as reported in the original papers
15. Data analysis plan
Please provide a brief summary of the analysis method
•Descriptive frequencies for insufficient reporting on specific parameters
•Standardized differences for baseline characteristics, incidence rates, and reported measures of association in original and replication
•Calibration of measures of association in the original and replication
•Relationship between lack of transparency in different areas (e.g. timing of cohort entry and follow up, algorithms to measure exposure, outcome, covariates etc.) and standardized differences in the original versus replication.
•Proportion of studies with clear design or analysis flaws stratified by type. These may include immortal time bias, reverse causation, adjustment for intermediates,etc.
•Plot measures of association with 95% CI for the original paper,replications using original methods, using plausible alternative choices, after external adjustment for residual confounding,after quantitative and probabilistic bias correction, after correction of clear design flaws,and using negative controls
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Wang, S.V., Sreedhara, S.K., Schneeweiss, S. et al. Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions. Nat Commun 13, 5126 (2022). https://doi.org/10.1038/s41467-022-32310-3https://www.nature.com/articles/s41467-022-32310-3
Wang SV, Sreedhara SK, Bessette LG, Schneeweiss S. Understanding variation in the results of real-world evidence studies that seem to address the same question. J Clin Epidemiol. 2022 Nov;151:161-170. doi: 10.1016/j.jclinepi.2022.08.012. Epub 2022 Sep 6. PMID: 36075314.https://www.jclinepi.com/article/S0895-4356(22)00212-8/fulltext
19. Other relevant documents
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Submitted
Signed Code of Conduct Declaration
Submitted
Signed Checklist for Study
Protocols
Submitted
