Article Text
Abstract
Objectives To understand the discrepancy between the published 10-year cardiovascular risk and 10-year cardiovascular risk generated from raw data using the Framingham Risk Score for participants in the Systolic Blood Pressure Intervention Trial (SPRINT).
Design Secondary analysis of SPRINT data published in The New England Journal of Medicine (NEJM) and made available to researchers in late 2016.
Setting SPRINT clinical trial sites.
Participants Study participants enrolled into SPRINT.
Results The number of SPRINT study participants identified as having ≥15% 10-year cardiovascular risk was not consistent with what was reported in the original publication. Using the data from the trial, the Framingham Risk Score indicated ≥15% 10-year cardiovascular risk for 7089 participants compared with 5737 reported in the paper, a change from 61% to 76% of the total study population.
Conclusions The analysis of the clinical trial data by independent investigators identified an error in the reporting of the risk of the study population. The SPRINT trial enrolled a higher risk population than was reported in the initial publication, which was brought to light by data sharing.
- clinical trials
- hypertension
- cardiovascular risk
- open data
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Footnotes
Contributors FW and HMK conceived and designed the work. FW wrote the first draft of the manuscript. FW, SSD, JSR, PD, KM and HMK analyzed and interpreted the data, revised the work critically for important intellectual content and approved the submitted version. FW and HMK are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests Drs HMK and JSR are recipients of research agreements from Medtronic and Johnson & Johnson (Janssen), through Yale, to develop methods of clinical trial data sharing and of a grant from Medtronic and the Food and Drug Administration, through Yale, to develop methods for postmarket surveillance of medical devices and work under contract with the Centers for Medicare and Medicaid Services to develop and maintain performance measures that are publicly reported. Dr HMK chairs a cardiac scientific advisory board for United Health, is a participant/participant representative of the IBM Watson Health Life Sciences Board, is a member of the Advisory Board for Element Science and the Physician Advisory Board for Aetna and is the founder of Hugo, a personal health information platform. Dr JSR has received research support from the Blue Cross Blue Shield Association to better understand medical technology evidence generation. The other co-authors report no potential competing interests.
Patient consent Not required.
Ethics approval Yale University Human Investigation Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The SPRINT data we used are available via the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).