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The American Journal of Managed Care March 2013
Rates of Guideline Adherence Among US Community Oncologists Treating NSCLC
Zhaohui Wang, MD, PhD; Inga Aksamit, RN, MBA; Lisa Tuscher, BA; and Kim Bergstrom, PharmD
Effectiveness and Cost-Effectiveness of Diabetes Prevention Among Adherent Participants
William H. Herman, MD, MPH; Sharon L. Edelstein, ScM; Robert E. Ratner, MD; Maria G. Montez, RN, MSHP; Ronald T. Ackermann, MD, MPH; Trevor J. Orchard, MD; Mary A. Foulkes, PhD; Ping Zhang, PhD; Christopher D. Saudek, MD†; and Morton B. Brown, PhD; The Diabetes Prevention Program Research Group
Mental Health in ACOs: Missed Opportunities and Low-Hanging Fruit
Allison N. O'Donnell, MPH; Brent C. Williams, MD; Daniel Eisenberg, PhD; and Amy M. Kilbourne, PhD, MPH
Drug Adherence After Price Changes in a Previously Compliant Population
James J. Hill III, MD, MPH; Deron Galusha, MS; Martin D. Slade, MPH; and Mark R. Cullen, MD
Measuring Quality in the Early Years of Health Insurance Exchanges
Ledia M. Tabor, MPH; Phyllis Torda, MA; Sarah S. Thomas, MS; and Jennifer L. Zutz, MHSA
Multilevel Predictors of Colorectal Cancer Screening Use in California
Salma Shariff-Marco, PhD, MPH; Nancy Breen, PhD; David G. Stinchcomb, MS, MA; and Carrie N. Klabunde, PhD
Engaging Providers in Underserved Areas to Adopt Electronic Health Records
Cleo A. Samuel, BS; Jennifer King, PhD; Fadesola Adetosoye, MS; Leila Samy, MPH; and Michael F. Furukawa, PhD
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Ishveen Chopra, MS; Khalid M. Kamal, PhD; Jayashri Sankaranarayanan, MPharm, PhD; and Gibbs Kanyongo, PhD
Currently Reading
Measuring Concurrent Oral Hypoglycemic and Antidepressant Adherence and Clinical Outcomes
Hillary R. Bogner, MD, MSCE; Heather F. de Vries, MSPH; Alison J. O'Donnell, BA; and Knashawn H. Morales, ScD
Low Clinical Utility of Folate Determinations in Primary Care Setting
Shlomo Vinker, MD; Eli Krantman, MD; Michal Shani, MD; and Sasson Nakar, MD
Trends in Inpatient Hospital Prices, 2008 to 2010
Jeff Lemieux, MA; and Teresa Mulligan, MHSA

Measuring Concurrent Oral Hypoglycemic and Antidepressant Adherence and Clinical Outcomes

Hillary R. Bogner, MD, MSCE; Heather F. de Vries, MSPH; Alison J. O'Donnell, BA; and Knashawn H. Morales, ScD
Self-reported adherence tended to overestimate medication adherence compared with electronic monitoring. Electronic monitoring of oral hypoglycemic agents but not self-reported adherence predicted glycemic control.
Objectives: Many patients experience difficulty in adhering to medication for both physical and mental health. Our objective was to compare selfreported adherence and electronic monitoring of adherence to oral hypoglycemic agents and antidepressants and to examine the relationship of adherence with clinical outcomes.


Study Design: Primary care–based longitudinal study.


Methods: Adherence was assessed in 180 patients prescribed pharmacotherapy for type 2 diabetes mellitus (T2DM) and depression enrolled in a randomized controlled trial of an integrated intervention for depression and T2DM. Adherence data were collected using self report and electronic monitoring. Glycated hemoglobin (A1C) assays were used to measure glycemic control, and the 9-item Patient Health Questionnaire assessed depression.


Results: At 12 weeks, self-reported adherence and electronic monitoring of adherence showed fair agreement (kappa = 0.213, P = .004 for oral hypoglycemic agents and kappa = 0.380, P <.001 for antidepressants). Patients who achieved >80% adherence to oral hypoglycemic agents measured with electronic monitoring were more likely to achieve A1C <7% compared with patients who did not achieve >80% adherence at 12 weeks (adjusted odds ratio = 3.52, 95% confidence interval 1.07-11.57). Self-reported adherence to oral hypoglycemic agents was not associated with diabetes outcomes. Measures of adherence for antidepressants were not associated with depression outcomes in models adjusted for potentially influential covariates.


Conclusions: Compared with electronic monitoring of adherence, self-reported adherence tended to overestimate medication adherence. Electronic monitoring of adherence to oral hypoglycemic agents predicted glycemic control, but self-reported adherence did not predict clinical outcomes.


Am J Manag Care. 2013;19(3):e85-e92
Poor adherence is a major obstacle to the benefit of medication regimens in the treatment of comorbid type 2 diabetes mellitus and depression.
 
  •  An accurate measure of patient adherence is essential for both clinicians and researchers to address this significant problem. Heavy reliance on self-reported adherence in practice could affect the quality of clinical care.
 
  •  Regular discussion of adherence is an important aspect of clinical encounters. Given a lack of identification of clear risk profiles for nonadherence, physicians may only be able to suspect nonadherence during the course of treatment for depression and diabetes.
Many patients do not take their medications as prescribed.1 In a systematic review the mean rate of medication adherence among patients with physical disorders was 76 percent, whereas the mean rate of antidepressant adherence was only 65 percent.2 The clinical effectiveness of interventions is substantially limited by less than optimal adherence, and improving adherence may have a far greater public health impact than any improvements in specific medical treatments.1,3 Medication nonadherence is associated with high rates of morbidity,4 mortality,5 and excess health expenditures.6

An accurate measure of patient adherence is essential for both clinicians and researchers to address this significant problem. Self-reported adherence is usually the only means available to clinicians to measure patient adherence to prescribed medication regimens and is an easy and commonly used method for research studies to assess adherence.7 However, self-report has been found to have low sensitivity for nonadherence and to operate well only over a short time frame.8,9 Electronic monitoring of adherence using microelectronic monitors on pill bottles that record the date and time of bottle opening has been identified as an informative technique allowing identification of the precise time of container opening. The validity and reliability of electronic monitoring of adherence provides a reference standard by which other adherence assessment methods can be examined.7,10

We sought to compare self-reported adherence and electronic monitoring of adherence with oral hypoglycemic agents and antidepressants because our prior work indicated participants think about their physical and mental health differently.11,12 Examining adherence simultaneously for both antidepressants and oral hypoglycemic agents is relevant to real-world clinical settings in which patients present with both physical and mental health concerns and are treated with multiple medications. No study to date has compared adherence assessment using self-reported adherence and electronic monitoring of adherence for both diabetes and depression. Depression is not only common in patients with diabetes but also contributes to poor adherence to medication and dietary regimens.13,14 Previous investigations have compared self-reported adherence and electronic monitoring of adherence to a single medication for a physical or mental health condition, but not both in the same people.15,16 In other work, a single measure of adherence has been used to assess adherence to multiple medications for 1 medical condition17 or adherence to medications for multiple conditions.18 In contrast, our study allows for an examination of measurement of adherence using both self-reported adherence and electronic monitoring of adherence in patients who are simultaneously prescribed medications for both a physical and a mental health condition.

The objective of our study was to compare self-reported adherence and electronic monitoring of adherence to oral hypoglycemic agents and antidepressants over time and to examine the relationship between the 2 methods of measuring adherence and glycemic control and depressive symptoms at 12 weeks in real-world practices with limited resources and competing demands. To accomplish these goals, we employed data from the randomized trial of a brief intervention to improve adherence through integrated management of type 2 diabetes mellitus (T2DM) and depression treatment. The study intervention was implemented at the individual level and involved an integrated care manager collaborating with physicians to offer education and guideline-based treatment recommendations, and monitor adherence and clinical status.19 Adherence, the percent of prescribed doses taken, was assessed at the >80% threshold because this cut point has been used as a standard with which other measures are compared.20,21 The study sample was an ethnically diverse sample of primary care patients. We hypothesized that: (1) self-reported adherence would overestimate adherence compared with electronic monitoring of adherence for both oral hypoglycemic agents and antidepressants; (2) patients with >80% adherence to an oral hypoglycemic agent using electronic monitoring would be more likely to achieve glycated hemoglobin (A1C) <7% at 12 weeks compared with patients who did not achieve >80% adherence at 12 weeks; and (3) patients with >80% adherence to an antidepressant medication measured using electronic monitoring would be more likely to achieve remission of their depression (9-item Patient Health Questionnaire <5) at 12 weeks compared with patients who did not achieve >80% adherence at 12 weeks.

METHODS

Recruitment Procedures


Patients were recruited from 3 primary care practices in Philadelphia, Pennsylvania. From April 2010 to April 2011, patients were identified through an electronic medical record with a diagnosis of T2DM, a prescription for an oral hypoglycemic agent within the past year, and a prescription for an oral antidepressant within the past year. Patients identified with an upcoming appointment were approached for further screening. The inclusion criteria were: 1) 30 years and older; 2) a diagnosis of T2DM and a current prescription for an oral hypoglycemic agent; and 3) a current prescription for an antidepressant. Exclusion criteria were: 1) inability to give informed consent; 2) significant cognitive impairment at baseline (Mini-Mental State Examination [MMSE] <21)22; 3) residence in a care facility that provides medications on schedule; and 4) unwillingness or inability to use the Medication Event Monitoring System (MEMS). Details of the study design are available elsewhere.19 The study protocol was approved by the University of Pennsylvania, Perelman School of Medicine Institutional Review Board.

Measurement Strategy

We used standard questions to obtain information from the patients on baseline age, self-reported ethnicity, gender, marital status, and education. Functional status was measured using the Medical Outcomes Study Short Form (SF-36).23 Patients brought all prescription bottles to the baseline visit. From each medication bottle, the name of the medication and the dose and frequency of the prescription were recorded. Patients were asked if they have received oral instructions to change the dose or frequency. If such a change was made without a change in the prescription bottle, the patient’s selfreport was recorded. Medical comorbidity was assessed by self-report at baseline. Cognitive status was measured using the MMSE, a short standardized mental status examination widely employed for clinical and research purposes.24

Adherence. Adherence to oral hypoglycemic agents and antidepressants was measured during a 2-week run-in phase to obtain a baseline measurement, and at 6 and 12 weeks, using self reports and electronic monitoring. Self-reported adherence was measured using the Brief Medication Questionnaire 5-item Regimen Screen. Patients were asked if they took their oral hypoglycemic agent and antidepressant in the past week. For each medication 4 questions were then asked: “How many days did you take it?”; “How many times per day did you take it?”; “How many pills did you take each time?”; and “How many times did you miss taking a pill?”.25 Patients were regarded as adherent if they reported taking 80% or more of their prescribed medications in the past week. Electronic monitoring of adherence was performed using microelectronic monitors (MEMS) (Figure 1). Use of MEMS on pill bottles allows identification of the precise date and time of container opening. Adherence measured using electronic monitoring was examined as the proportion of medication vial cap openings in a given week relative to the prescribed doses for the week. As in prior investigations,26-29 the final week of self-reported adherence was examined in order to minimize recall bias and elicit more accurate responses. Patients were blinded to which week of participation was being employed for analysis in order to avoid potential bias.

Glycemic Control. At baseline and 12 weeks blood glycemic control was assessed in accordance with American Diabetes Association Guidelines.30 The 3-month time frame was assessed because of its signifi cance for diagnostic accuracy of glucose titration for A1C assessment.30 A1C assays were performed employing the in2it A1C Analyzer. Point of care testing using this device has acceptable precision and agreement compared with laboratory services.31

Depression. Depressive symptoms were measured using the 9-item Patient Health Questionnaire (PHQ-9) at baseline and 12 weeks. The PHQ-9 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 depression module, which scores each of the 9 DSM-IV criteria as “0” (not at all) to “3” (nearly every day), is a reliable tool for screening and monitoring designed for primary care settings.32 A PHQ-9 score of 10 or greater was associated with a high sensitivity and a high specificity for major depression.33 In order to include as many persons who were willing and able to participate as possible we chose to include participants with a range of depressive symptoms reflecting the concept of the relapsing, remitting nature of depression in primary care.34

Analytic Strategy

Adherence was defi ned as the percent of prescribed doses taken and was calculated as the number of doses taken divided by the number of doses prescribed over the preceding 1-week period  100%. Adherence was dichotomized at a threshold of 80% because the proportion of pills taken was highly skewed and failed normality assumptions. Adherence, the percent of prescribed doses taken, was assessed at the >80% threshold because this cut point is both conservative in detecting nonadherence and is aligned with adherence assessments in prior investigations from mental health16,35 and diabetes.18,36 Because only 2 participants (1.1%) had extra bottle openings, these openings were excluded from our analysis.

Our analysis proceeded in 2 phases. In the first phase, using adherence dichotomized at a threshold of 80%, the kappa coefficient was used to assess the magnitude of agreement between self-reported adherence and electronic monitoring. The kappa coefficient was used because it assesses the chancecorrected agreement between these 2 methods of measuring adherence.

 
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