Elsevier

Clinical Therapeutics

Volume 31, Issue 2, February 2009, Pages 421-435
Clinical Therapeutics

A framework for planning and critiquing medication compliance and persistence research using prospective study designs

https://doi.org/10.1016/j.clinthera.2009.02.021Get rights and content

Abstract

Background: Medication compliance and persistence are important determinants of clinical outcomes. With the application of evidence-based therapy, it is increasingly important to ensure that studies that use compliance or persistence as a primary or secondary outcome are designed suitably and employ appropriate analyses to support the inferences made.

Objective: The aim of this work was to describe the designs of medication compliance/persistence studies and provide guidance on appropriate analyses, with the ultimate goal of helping health providers and payers of health care understand the impact of compliance and persistence on health outcomes.

Methods: MEDLINE, CINAHL, EMBASE, and all EBM Reviews databases were searched to locate key research articles about prospective medication compliance and persistence studies. Articles published between 1978 and 2008 were included in the search. Inclusion criteria included a focus on medication compliance and persistence, and prospective research designs. Articles that largely focused on retrospective study designs or were based on opinion rather than evidence were excluded.

Results: A systematic framework was developed that comprised a prospective checklist and a quantitative tool to assess the quality of studies. The key elements of the checklist included the following: title and abstract, introduction or background, objectives, methods and study design, statistical analysis and results, discussion, conclusions, and disclosure of conflicts of interest. For each element, examples are provided to help readers make an informed decision about the design, value, and quality of a particular prospective study.

Conclusions: The checklist and quantitative tool can be used to provide objective validation of the rigor of prospective research designs. It is anticipated that future research will follow a uniform approach to presentation and evaluation of data, thereby facilitating a clear understanding of the impact of compliance and persistence on health outcomes.

References (96)

  • GH Guyatt et al.

    Users' Guides to the Medical Literature: XXV. Evidence-based medicine: Principles for applying the Users' Guides to patient care

    JAMA

    (2000)
  • G Guyatt et al.
  • LM Friedman et al.
  • National Cancer Institute. Theory at a Glance: A Guide for Health Promotion Practice [National Cancer Institute Web...
  • K Glanz et al.
  • J Adams et al.

    Predicting medication adherence in severe mental disorders

    Acta Psychiatr Scand

    (2000)
  • J Scott

    Using Health Belief Models to understand the efficacy-effectiveness gap for mood stabilizer treatments

    Neuropsychobiology

    (2002)
  • RG Steele et al.

    Adherence to antiretroviral therapy among HIV-positive children: Examination of the role of caregiver health beliefs

    AIDS Care

    (2001)
  • J Ogden
  • W Edwards

    The theory of decision making

    Psychol Bull

    (1954)
  • D Whitehead

    A social cognitive model for health education/health promotion practice

    J Adv Nurs

    (2001)
  • JO Prochaska et al.

    In search of how people change. Applications to addictive behaviors

    Am Psychol

    (1992)
  • Family Health International (FHI). Behavior Change—A Summary of Four Major...
  • GS Brassington et al.

    Intervention-related cognitive versus social mediators of exercise adherence in the elderly

    Am J Prev Med

    (2002)
  • M Conner et al.

    A social cognitive approach

  • JA Cramer et al.

    Medication compliance and persistence: Terminology and definitions

    Value Health

    (2008)
  • T Montague
  • E Vermeire et al.

    Patient adherence to treatment: Three decades of research. A comprehensive review

    J Clin Pharm Ther

    (2001)
  • S Lash et al.

    “Abandoned prescriptions”: A quantitative assessment of their cause

    J Managed Care Pharm

    (1995)
  • JA West et al.

    A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization

    Am J Cardiol

    (1997)
  • MR DiMatteo et al.

    Depression is a risk factor for noncompliance with medical treat ment: Meta-analysis of the effects of anxiety and depression on patient adherence

    Arch Intern Med

    (2000)
  • MR DiMatteo et al.

    Patient adherence and medical treatment out comes: A meta-analysis

    Med Care

    (2002)
  • MM McDermott et al.

    Impact of medication nonadherence on coronary heart disease outcomes. A critical review

    Arch Intern Med

    (1997)
  • Special Report: Interventions to improve patient adherence with medications for chronic cardiovascular disorders

    TEC Bull (Online)

    (2003)
  • SH Simpson et al.

    A meta-analysis of the association between adherence to drug therapy and mortality

    BMJ

    (2006)
  • RA Elliott et al.

    Cost-effectiveness of adherence-enhancing interventions: A quality assessment of the evidence

    Ann Pharmacother

    (2005)
  • CI Volume et al.

    Pharmaceutical care research and education project: Patient outcomes

    J Am Pharm Assoc (Wash)

    (2001)
  • B Vrijens et al.

    Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin

    Pharmacoepidemiol Drug Saf

    (2006)
  • FH Gwadry-Sridhar et al.

    Pilot study to determine the impact of a multidisciplinary educational intervention in patients hospitalized with heart failure

    Am Heart J

    (2005)
  • CONSORT Group. The CONSORT...
  • RB Haynes et al.
  • PJ Diggle et al.
  • D Moher et al.

    The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials

    Ann Intern Med

    (2001)
  • DG Altman et al.

    The revised CONSORT statement for reporting randomized trials: Explanation and elaboration

    Ann Intern Med

    (2001)
  • GR Norman et al.
  • RB Haynes et al.

    Interventions to enhance medication adherence

    Cochrane Database Syst Rev

    (2005)
  • Cited by (34)

    • Guidelines and standards in medication adherence research

      2022, Contemporary Research Methods in Pharmacy and Health Services
    • Patient Reported Outcomes following initiation of Glucagon-like peptide-1 Receptor agonists in patients with type 2 Diabetes in a specialist endocrinology practice of the LMC diabetes registry: The PROGRESS-Diabetes study

      2019, Diabetes Research and Clinical Practice
      Citation Excerpt :

      A strength of this study is the availability of a large sample of adults with T2D initiating dulaglutide or liraglutide, within one practice group all following the national clinical practice guidelines [22] within a public health system. The cohort study design may have specific advantages compared to an RCT[23], especially in investigations of adherence, and may be more generalizable to clinical practice. There was a high completion rate for the questionnaires (90%).

    • Measuring oral contraceptive adherence using self-report versus pharmacy claims data

      2017, Contraception
      Citation Excerpt :

      Using pharmacy claims medication refill data may be superior to self-report by avoiding biases related to self-report; however, these methods have only been compared directly in a few contraception studies. One study indicated a discrepancy between self-report and pharmacy claims data, wherein 59% of 769 women reported continuous use of OCPs for 12 months but only 39% had enough pills supplied for 12 months of continuous use [9], suggesting that self-report data may not be a valid adherence measure [10]. Medication adherence encompasses both use consistency and continuity (i.e., absence of gaps in use).

    • The association between patient activation and medication adherence, hospitalization, and emergency room utilization in patients with chronic illnesses: A systematic review

      2015, Patient Education and Counseling
      Citation Excerpt :

      Emerging evidence also suggests that patient activation is a factor that may predict hospitalization, emergency room utilization, and/or medication adherence in chronically ill populations [21,24,25]. Moreover, studies have underscored the impact of poor medication adherence on increased hospitalization and emergency room utilization in chronically ill populations [26–29]. Currently, the Patient Activation Measure (PAM) is the only validated instrument that comprehensively measures the degree to which patients are activated to manage their own health care [22] The PAM, which was developed and refined by Hibbard et al., contains Likert-response questions each soliciting unique information on the patient's knowledge, skills, and beliefs to self-manage their own care, collaborate with their health care providers, and maintain health behaviors while preventing decline (Table 1).

    View all citing articles on Scopus
    View full text