Original ResearchPredictive Validity of Self-Reported Measures of Adherence to Noninsulin Antidiabetes Medication against Control of Glycated Hemoglobin Levels
Introduction
Poor adherence to antidiabetes drug treatment is a major barrier to achieving clinical targets in type 2 diabetes (1). Unfortunately, adherence to antidiabetes drug treatment is suboptimal 1, 2. Therefore, there is a need in clinical practice to identify nonadherent patients in order to help them to manage their treatments better and to benefit from better health outcomes.
Many methods are available to measure adherence to drug treatment. They all come with strengths and limitations (3). In clinical practice, the advantages of self-reported measures over other methods include simplicity, ease of administration, cost-effectiveness (3) and capacity to identify underlying issues contributing to nonadherence (4).
There are 3 general types of self-reported measures: 1) medication-taking habits; 2) general adherence tendencies and 3) specific quantities of pills missed over an identified period of time, expressed as a proportion (5). On one hand, medication-taking habit measures are usually multiple-item scales. They can help to distinguish between intentional and unintentional nonadherence, which have different underlying causes and, therefore, require differing interventions (6). However, characteristics of the item questions and literacy issues could influence their validity (3). On the other hand, measures of general adherence tendency are usually single-item scales that can be used in busy clinical settings. Unfortunately, as a single-item scale, those measures have little value in identifying reasons for nonadherence. Finally, by their nature, self-reported measures of the proportion of pills missed do not provide reasons that can explain nonadherence. Their accuracy can also be influenced by the number of drugs being used and by the length of the recall time period 5, 7.
The validity of those 3 types of measures, when used to assess adherence to antidiabetes drug treatment, has been evaluated 8, 9, 10. However, little is known about their comparative validities. In one study (8), a self-reported general adherence tendency measure was compared to a self-reported proportion of pills missed. The former measure was more strongly correlated than the latter with glycemic control and with adherence measured by using an electronic medication-monitoring system (8). To our knowledge, a head-to-head assessment of the validity of the 3 types of self-reported measures of adherence to antidiabetes drugs treatment has never been conducted.
The present study was designed to assess and compare the sensitivity and specificity of 3 different types of self-reported antidiabetes drug-adherence measures in predicting control of glycated hemoglobin (A1C) levels in patients with type 2 diabetes.
Section snippets
Study design
We carried out a validation study in which self-reported adherence was measured at baseline, and A1C levels were measured between 3 and 6 months later. The following self-reported measures were assessed: 1) 2 medication-taking habits measures, i.e. a 4-item self-report (SR-4) and the 8-item Morisky Medication Adherence Scale (MMAS-8); 2) a self-reported proportion of pills missed measure developed by Godin et al (7); and 3) a single-item scale (i.e. a general tendency measure) developed by our
Results
Of the 221 individuals who were contacted in order to obtain measures of their A1C levels, a total of 156 (70.6%) agreed to participate and were, therefore, sent A1C tests by mail. Of those, 153 sent back their A1C level results. A majority of participants were male, retired, had at least college-level education and were of the median age of 64.3 years (Table 1). Among them, 87 participants (56.8%) had suboptimal glycemic control (A1C level >7%).
Table 2 displays the self-reported adherence
Discussion
In this convenience sample of individuals with type 2 diabetes using noninsulin antidiabetes drugs, 56% did not achieve glycemic control. This proportion is similar to the proportion observed in a national survey of Canadian outpatients with type 2 diabetes that was conducted in 2012. In that study, 50% of patients had A1C levels above 7% (21). Moreover, the ages of the participants, the duration of diabetes and the body mass indices were also similar to those observed in our study.
Irrespective
Conclusion
In the absence of a gold-standard measure of medication adherence, we assessed the validity of 3 types of self-reported measures by using A1C levels as the validation criterion. Our results suggest that the self-reported proportion of pills should not be used to assess adherence to the noninsulin antidiabetes drugs treatment. On the other hand, the results suggest that among the self-reported adherence measures we have tested, the SR-4 is the one that should be preferred in both research and
Author Contributions
AZ made substantial contributions to the conception, design, analysis and interpretation of the data, drafted the article, and gave final approval of the version to be published; LG made substantial contributions to the conception, design and interpretation of the data, revised the article critically and gave final approval of the version to be published; JM made substantial contributions to the analysis and interpretation of the data, revised the article critically and gave final approval of
Acknowledgements
Funding for this work was provided by Diabète Québec and the Chair on adherence to treatments. This Chair is supported by unrestricted grants from AstraZeneca Canada, Merck Canada, Pfizer Canada, Sanofi Canada and the Prends soin de toi program. The A1CNow SelfCheck applications were provided by Bayer.
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