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Patient self-reporting of compliance does not correspond with electronic monitoring: an evaluation using isosorbide
R J Straka1, J T Fish, S R Benson
1Department of Pharmacy Practice, College of Pharmacy, University of Minnesota, Minneapolis 55455, USA.
Insights
Patient diaries overestimate medication adherence compared to electronic monitoring. This suggests reevaluating diary use in clinical trials where precise dosing is critical for ischemic heart disease outcomes.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Medical Device Technology
Background:
- Patient adherence to prescribed medication regimens is crucial for effective treatment of chronic conditions like ischemic heart disease.
- Isosorbide dinitrate is commonly prescribed for ischemic heart disease, but its efficacy depends on consistent administration.
- Accurate methods for monitoring patient compliance are essential for evaluating drug efficacy and understanding treatment outcomes.
Purpose of the Study:
- To compare the accuracy of patient-kept diaries against electronic monitoring for assessing compliance with isosorbide dinitrate.
- To evaluate the reliability of self-reported medication adherence in clinical research settings.
Main Methods:
- A prospective, unblinded study involving stable outpatients with coronary artery disease prescribed isosorbide dinitrate three times daily.
- Patients recorded medication administration times in pocket diaries.
- Compliance was simultaneously monitored using a computerized Medication-Event Monitoring System (MEMS-4) vial.
Main Results:
- Patient-kept diaries showed statistically higher compliance rates (71%) compared to MEMS vials (55%) (p = 0.001).
- Approximately 67% of patients overestimated their compliance when using self-recording diaries.
- An average of 30% of diary entries contained errors when compared to electronic records.
Conclusions:
- Patient-kept diaries significantly overestimate medication compliance compared to electronic monitoring devices like MEMS.
- The findings question the reliability of diaries for documenting drug adherence in research, especially when dose timing is critical for outcomes.
- Poor compliance rates observed suggest a need to reevaluate the clinical utility of isosorbide dinitrate when prescribed three times daily for angina.
Study Objective:
To assess the accuracy of patient-kept diaries relative to electronic monitoring of compliance with isosorbide dinitrate prescribed 3 times/day for ischemic heart disease.
Design:
Unblinded, prospective, three-phase study.
Methods:
Patients with coronary artery disease prescribed isosorbide dinitrate 3 times/day were asked to record the time of administration of each dose in a pocket diary while being monitored for compliance with a computerized Medication-Event Monitoring System (MEMS-4) vial that electronically recorded the date and time the vial was opened.
Results:
Sixty-eight stable outpatients with documented coronary artery disease who were prescribed isosorbide dinitrate 3 times/day were evaluated. Based on a prospectively chosen definition including a nitrate-free period, the mean (+/-SD) overall compliance rates were 71% (+/-30) versus 55% (+/-32) for the patient-kept diaries and the MEMS vials respectively (p = 0.001). The concordance between patient-kept diaries and MEMS data indicate that 67% of patients overestimate their compliance when using a self-recording tool. An average of 30% of diary entries were in error compared with the MEMS vial recordings.
Conclusions:
Patient-kept diaries statistically overestimate actual compliance relative to that determined by MEMS devices. Given the prevalence of the use of diaries as the predominant tool on which researchers depend to document compliance with study drugs, our findings suggest that this practice should be reevaluated specifically when the time of the dose and documentation of administration are critical to qualifying the outcome of drug therapy. Such is the case with isosorbide dinitrate use in patients with ischemic heart disease. Furthermore, the overall poor compliance documented in this study suggests that the utility of isosorbide dinitrate prescribed 3 times/day be reevaluated as a clinically effective antianginal drug.