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.
Pubmed ID: 30037874
Pubmed Central ID: PMC6059296
Journal: BMJ open
Publication Date: July 23, 2018
MeSH Terms: Humans, Cardiovascular Diseases, Hypertension, Randomized Controlled Trials as Topic, Systole, Antihypertensive Agents, Blood Pressure Determination
Authors: Krumholz HM, Ross JS, Dhruva SS, Warner F, Dey P, Murugiah K
Cite As: Warner F, Dhruva SS, Ross JS, Dey P, Murugiah K, Krumholz HM. 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. BMJ Open 2018 Jul 23;8(7):e021685.
Studies:
- Systolic Blood Pressure Intervention Trial (SPRINT)
- Systolic Blood Pressure Intervention Trial Primary Outcome Paper (SPRINT-POP) Data
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 <i>The New England Journal of Medicine</i> (<i>NEJM</i>) 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.