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.

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.