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  • 494 JCOM November 2013 Vol. 20, No. 11 www.jcomjournal.com

    adherence to diabetes Medications

    ABSTRACT Objectives: To conduct a systematic review of the

    literatureexamininginterventionsdeliveredbyhealthcarepractitionerstoimprovemedicationadherenceinpatientswithdiabetesmellitus(DM).

    Methods: Databases were searched up to 2 July2013toidentifyeligiblestudiesthatincludedinterven-tions that were conducted in a clinic-based settinganddeliveredbyahealthcarepractitioner(eg,nurse,physician,diabeteseducator) to improveadherencetodiabetesmedications(includingoralhypoglycemicagentsandinsulin).Articleswerelimitedtopublishedclinical trials conducted inadults 18yearsofageandpublishedinEnglish-languagejournals.

    Results:18paperswerereviewed:15trialstargetedpatientswithDM,3targetedhealthcarepractitioners.7 patient-focused and 1 practitioner-focused trialdemonstrated a beneficial effect of the interventioncomparedwithacontrol group.Thepatient-focusedtrialswerecomplex interventions involvingacombi-nation of adherence-enhancing strategies such asindividualizedpatientcounseling,tailoredpatientedu-cation, medication reminders, behavioral feedbackand reinforcement, and caremanagement byancil-lary staff, nurses, text message or telephone-linkedsystem. The practitioner-focused trial employed anelectronicfeedbacksystemforindividualizedcareandquality improvement.Limitationsincludedthediversityin the measures employed to assess adherence; dif-feringdefinitionsofadherence;theinclusionofpatientsregardlessofbaselineadherencestatus;andtheshortdurationofthetrials.

    Conclusions:Additionalresearchisneededtounder-standtheconditionsunderwhichinterventionstarget-ing thepatient-practitioner interaction canbe imple-mentedinclinicsettingstoimprovemedicationadher-enceinpatientswithDM.

    The prevalence of diabetes mellitus (DM) has grown to epidemic proportions. DM affects nearly 26 million Americans, ranking as the 7th leading cause of death in the United States, and is a major risk factor for stroke, heart disease, kidney disease, blindness and lower-limb amputations [1]. Despite the availability of numerous efficacious treatments (eg, oral hypoglyce-mic agents and insulin) to manage DM, and their proven efficacy in reducing cardiovascular morbidity and mor-tality, adherence to treatment remains suboptimal [2]. Recent systematic reviews have documented medication adherence rates for oral hypoglycemic agents (as assessed by self-report and objective measures) ranging from 36% to 93% among patients with DM [3,4]. Rates of insulin adherence range from 62% to 64% depending on the population studied [3]. Poor adherence to DM treatments is a major contributor to inadequate glycemic control and is estimated to incur up to $289 billion annually in direct healthcare costs [57]. Given these consequences, patient nonadherence has been described as one of the greatest challenges for successful treatment of chronic diseases such as DM [8].

    The definition of medication adherence has taken nu-merous forms over time. Once regarded as the patients responsibility (eg, compliance), the success of the pre-scribed medication in reaching the intended therapeutic target rested solely on the patients ability to understand and execute the health care practitioners directions [9]. More recently, adherence has been recognized as a com-plex behavior that requires patients and practitioners to form a partnership based on a shared understanding of one anothers perspectives within a supportive healthcare

    A Systematic Review of Interventions to Improve Adherence to Diabetes Medications within the PatientPractitioner Interaction Antoinette Schoenthaler, EdD, and Yendelela L. Cuffee, PhD, MPH

    From the Center for Healthful Behavior Change, Department of Population Health, New York University School of Medi-cine, New York, NY.

  • www.jcomjournal.com Vol. 20, No. 11 November 2013 JCOM 495

    delivery system [8,10]. When patients and practitioners engage in a collaborative relationship that includes shared decision-making [11,12], patient-centeredness [1315], and information exchange[16,17], patients are more likely to report better adherence to their medications.

    While much work has been done to identify patient factors, and to a lesser extent practitioner factors, associ-ated with better medication adherence in patients with DM in observational studies, effective intervention ap-proaches that practitioners can incorporate into clinical practice has not been evaluated. In this systematic review, we appraise the existing literature examining interven-tions delivered by health care practitioners on medication adherence in patients with DM.

    METHODSSearch StrategyThe search strategy were similar to the ones used by Cra-mer et al [3] (in their systematic review of adherence to diabetes medications) and McDonald et al [18] (in their systematic review of interventions to improve adherence to medications). To identify manuscripts that met inclu-sion criteria for this review, we used standard Cochrane Collaboration systematic review techniques [19]. The PubMed and EMBASE databases were searched from in-ception to 2 July 2013 for our concepts. In addition, key articles from each search were run in PubMed using the related articles feature to identify further articles. Ad-ditional strategies included searching the bibliographies of eligible articles and searching other systematic reviews and meta-analyses for relevant articles. The concepts for medication adherence, intervention type, and diabetes were included in the search with several keyword syn-onyms and the subject headings for practitioner-patient relations. Articles were limited to reports of clinical trials published in English-language peer-reviewed journals and conducted in adults (age 18 years). The full search strategy in PubMed is available online.

    Eligibility CriteriaStudies were eligible for the review if they met the fol-lowing criteria: (1) patients had a diagnosis of diabetes; (2) included an intervention to improve adherence to dia-betes medications (including oral hypoglycemic agents and insulin); (3) there was assessment of medication adherence as an outcome either through electronic moni-toring devices, self-report, pill counts or pharmacy refills; (4) the intervention took place in a clinic-based setting

    and delivered by a health care practitioner, defined as either a nurse, physician, diabetes educator, or care man-ager; and (5) the study was a clinical trial (case-control study or randomized controlled trial [RCT]). We ex-cluded studies that included pharmacist-led interventions given that this topic has been addressed in other recent systematic reviews [2024]. We also excluded studies that did not report adherence rates for diabetes medications or the methods used to determine medication adherence. The outcome of interest was the between-group differ-ence in medication adherence between intervention and control arms.

    Data ExtractionAll titles and abstracts from the search were reviewed independently by the authors. Citations were categorized as potentially relevant, not clearly relevant, or gave insuf-ficient information to make a judgment. Any disagree-ments about inclusion in the review were discussed by the authors, with all differences resolved by consensus. Percent agreement between the 2 authors was high (86%) across all reviewed citations. Printed copies of all poten-tially relevant citations were obtained. The authors inde-pendently abstracted all data from the eligible citations. Data were abstracted from tables, figures, and text using a structured data collection form. Data including partici-pant and site characteristics, study methods, outcomes, and risk of bias were collected on the form. In addition, 2 authors of potentially relevant citations were contacted about unpublished data. Risk of bias for each study was assessed using the guidelines outlined in The Cochrane Collaboration Handbook for Systematic Review of Interventions [19]. Percent agreement between the au-thors was high (96%) across all abstracted data.

    RESULTS

    A total of 1011 articles were identified, 24 of which were extracted for full review. Six of these studies were ex-cluded for one of the following reasons: incomplete data on adherence outcome [25, 26], the intervention was not clinic-based [2729], or the adherence assessment was not specific to diabetes medications [30]. Thus, 18 trials were included in this systematic review [3148]. (See page 528 for a Figure summarizing the literature search results.)

    Trial Characteristics The characteristics of the included trials are shown in Table 1. Seventeen of the included studies were RCTs

    CliniCal Review

  • 496 JCOM November 2013 Vol. 20, No. 11 www.jcomjournal.com

    adherence to diabetes Medications

    [3137, 3948] and 1 was a single-group pre-post study [38]. Among the RCTs, the comparison group was usual care (UC) in 11 trials [3234, 36, 3942, 4446]. An attention control (ie, sessions that are peripheral to the intervention topics to control for additional time and attention) or a minimal intervention was used in 6 tri-als [31, 35,37,43,47,48]. Approximately one-third of the trials (n = 7) were conducted in the United States [32,33,37,41,42,44,45]. The number of participating clin-ics per trial ranged from 1 to 86 (mean, 15). The majority of the trials (n = 11) were conducted in primary care clinics [3237,41,42,4446]. Seven trials were conducted in spe-cialty clinics (eg, endocrinology clinic) or tertiary hospital settings [31,3840,43,47,48].

    Fifteen of the trials targeted patients [3135,3741,4345,47,48] and 3 targeted practitioners [36,42,46]. The sample size of the trials ranged from 45 to 2458 patients (median, 197) and 40 to 160 practitioners (me-

    dian, 140). Fifty-four percent of the patient

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