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Development and internal validation of GENADHECAR: a screening instrument for identifying probable statin
Jose A Quesada1,2,3,4,5,6, Adriana López-Pineda1,2,3,4,5,6, Rauf Nouni-García2,4,5,6,7
1Department of Clinical Medicine, Miguel Hernández University (UMH), Sant Joan D'Alacant, Spain.
Insights
A new screening tool, GENADHECAR, was developed to identify patients at risk of statin non-adherence. This practical instrument uses questionnaire items and sociodemographic data to help clinicians identify patients needing support for cardiovascular disease secondary prevention.
Area of Science:
- Cardiology
- Pharmacology
- Health Services Research
Background:
- No validated, practical tool exists for assessing statin adherence in cardiovascular disease secondary prevention.
- Current reference methods (e.g., plasma drug measurements) are not feasible for routine clinical use or large trials.
Purpose of the Study:
- To develop and internally validate a predictive screening instrument for identifying patients at risk of statin non-adherence.
Main Methods:
- A multicenter cross-sectional study involving 309 patients with ischemic heart disease.
- Developed a multivariate predictive model using questionnaire items (reminders, forgetfulness, medication access) and sociodemographic variables (sex, education).
- Validated the model against a pharmacokinetic reference method (plasma statin concentrations).
Main Results:
- The final GENADHECAR instrument identified 15.9% of patients as non-adherent.
- Internal validation showed moderate discrimination (AUC 0.694) and high capacity to identify patients at low risk of non-adherence.
- The tool demonstrated good calibration and predictive values, particularly the negative predictive value (0.92).
Conclusions:
- GENADHECAR is the first validated screening instrument for statin non-adherence using a pharmacokinetic reference.
- It offers a brief, practical approach to identify at-risk patients, potentially overcoming limitations of self-report methods.
- Further external validation is recommended prior to routine clinical implementation.
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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