Key result
GENADHECAR screening tool yields moderate discrimination with an AUC of ~0.69 for statin non-adherence.
Why the study?
No validated, practical tool exists to assess statin adherence in secondary cardiovascular prevention, and reference methods like plasma drug measurements are not feasible for routine care.
Does the GENADHECAR screening instrument accurately identify statin non-adherence in patients with ischemic heart disease?
Cross-Sectional (n=309)
Yes
Does the GENADHECAR screening instrument accurately identify statin non-adherence in patients with ischemic heart disease?
The GENADHECAR screening instrument provides a brief, internally validated tool to identify probable statin non-adherence in patients with ischemic heart disease, offering a practical alternative to complex pharmacokinetic testing.
Answers are grounded in this paper and cite their sources.
May support statin non-adherence screening in secondary prevention; leaves open external validation before clinical use.
Background: No validated and practical tool exists to assess adherence to statins in secondary prevention of cardiovascular disease. Current reference methods for assessing adherence, including plasma drug measurements, are not feasible for routine clinical care or large clinical trials. Objective: To develop and internally validate a predictive screening instrument for identifying patients at risk of statin non-adherence. Methods: This multicenter cross-sectional study reports the results of the second phase of the GENADHECAR project in four Spanish hospitals. An initial set of 42 adherence-related items was refined and evaluated in a sample of patients with ischemic heart disease. Responses were compared against a pharmacokinetic reference method (plasma statin concentrations) to assess recent medication intake. A multivariate predictive model of non-adherence was then developed, selecting the best predictors and covariates to be included in the final screening instrument. Results: A total of 309 patients were included, of whom 49 (15.9%) were classified as non-adherent according to the pharmacokinetic reference method. The final GENADHECAR screening instrument comprised three questionnaire items (use of reminders, forgetfulness, and medication access) and two sociodemographic variables (sex and educational attainment). Internal bootstrap validation yielded an optimism-corrected AUC of 0.694 (95% CI 0.617-0.767), with adequate calibration (Hosmer-Lemeshow p = 0.994). At the selected probability threshold (0.15), sensitivity was 0.73, specificity 0.61, and positive and negative predictive values were 0.26 and 0.92, respectively. Overall, the model showed moderate discrimination and a high capacity to identify patients at low risk of non-adherence. Conclusion: To our knowledge, GENADHECAR is the first screening instrument with internal validation to identify statin non-adherence using a pharmacokinetic reference method. It offers a brief and practical approach for identifying patients at risk of non-adherence and may help overcome some limitations of conventional self-report methods in this population. Further external validation is needed before routine clinical implementation.
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Quesada et al. (2026) conducted a cross-sectional in Ischemic heart disease (n=309). GENADHECAR screening instrument vs. Pharmacokinetic reference method (plasma statin concentrations) was evaluated on Identification of statin non-adherence (model discrimination) (AUC 0.694, 95% CI 0.617-0.767). The GENADHECAR screening instrument demonstrated moderate discrimination with an optimism-corrected AUC of 0.694 for identifying probable statin non-adherence in patients with ischemic heart disease.
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