Key result
Patient self-report of cardiovascular diagnoses showed variable agreement with medical records, with kappa values ranging from 0.89 for diabetes to 0.04 for angina.
Why the study?
Does patient self-report accurately reflect medical records for cardiovascular diagnoses in patients with hypercholesterolemia?
RCT (n=7,640)
Yes
Does patient self-report accurately reflect medical records for cardiovascular diagnoses in patients with hypercholesterolemia?
Effect estimate: kappa values ranging from 0.89 for diabetes to 0.04 for angina
The accuracy of patient self-reported cardiovascular diagnoses is highly variable and often poor, highlighting the need for data validation in clinical studies and practice.
Self-reported diagnoses should not yet change practice without verification; leaves open optimal validation methods in hypercholesterolemia research.
BACKGROUND: To determine the accuracy of patient self-reports of specific cardiovascular diagnoses and to identify individual patient characteristics that influence the accuracy. METHODS: This investigation was conducted as a part of the randomized controlled ORBITAL study. Patients with hypercholesterolemia were enrolled in 1961 primary-care centers all over Germany. Self-reported questionnaire data of 7640 patients were compared with patients' case report forms (CRFs) and medical records on cardiovascular diseases, using kappa statistics and binomial logit models. RESULTS: kappa values ranged from 0.89 for diabetes to 0.04 for angina. The percentage of overreporting varied from 1% for diabetes to 17% for angina, whereas the percentage of underreporting varied from 8.0% for myocardial infarction to 57% for heart failure. Individual characteristics such as choice of individual general practitioner, male gender and age were associated with the accuracy of self-report data. CONCLUSION: Since the agreement between patient self-report and CRFs/medical records varies with specific cardiovascular diagnoses in patients with hypercholesterolemia, the adequacy of this tool seems to be limited. However, the authors recommend additional data validation for certain patient groups and consideration of individual patient characteristics associated with over- and underreporting.
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Englert et al. (2010) conducted an RCT in Hypercholesterolemia (n=7,640). Patient self-report of cardiovascular diagnoses vs. Case report forms (CRFs) and medical records was evaluated on Accuracy of patient self-reports of specific cardiovascular diagnoses (kappa values ranging from 0.89 for diabetes to 0.04 for angina). Patient self-report of cardiovascular diagnoses showed variable agreement with medical records, with kappa values ranging from 0.89 for diabetes to 0.04 for angina.
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