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BMJ Open. 2018 Jul 23;8(7):e021685. doi: 10.1136/bmjopen-2018-021685.

Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population.

Warner F1,2, Dhruva SS3,4, Ross JS1,3,5,6, Dey P1,7, Murugiah K1,2, Krumholz HM1,2,6.

Author information

1
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USA.
2
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
3
National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
4
Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA.
5
Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
6
Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, USA.
7
Yale School of Medicine, New Haven, Connecticut, USA.

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.

KEYWORDS:

cardiovascular risk; clinical trials; hypertension; open data

Conflict of interest statement

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.

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