This paper is only available as a PDF. To read, Please Download here.
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.
Key words:
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Users' Guides to the Medical Literature: XXV. Evidence-based medicine: Principles for applying the Users' Guides to patient care.JAMA. 2000; 284: 1290-1296
- Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. 2nd ed. McGraw-Hill, New York, NY2008
- Fundamentals of Clinical Trials. 2nd ed. PSG Publishing, Littleton, MA1985
- A checklist for medication compliance and persistence studies using retrospective databases.Value Health. 2007; 10: 3-12
National Cancer Institute. Theory at a Glance: A Guide for Health Promotion Practice [National Cancer Institute Web site].
- http://www.cancer.gov/aboutnci/oc/theoryat-a-glance(Accessed)Date: August 10, 2008
- Health Behavior and Health Education: Theory, Research, and Practice. 3rd ed. Jossey-Bass, San Francisco, CA2002
- Predicting medication adherence in severe mental disorders.Acta Psychiatr Scand. 2000; 101: 119-124
- Using Health Belief Models to understand the efficacy-effectiveness gap for mood stabilizer treatments.Neuropsychobiology. 2002; 46: 13-15
- Adherence to antiretroviral therapy among HIV-positive children: Examination of the role of caregiver health beliefs.AIDS Care. 2001; 13: 617-629
- Health Psychology: A Textbook. 2nd ed. Open University Press, Buckingham, UK2000
- The theory of decision making.Psychol Bull. 1954; 51: 380-417
- A social cognitive model for health education/health promotion practice.J Adv Nurs. 2001; 36: 417-425
- In search of how people change. Applications to addictive behaviors.Am Psychol. 1992; 47: 1102-1114
Family Health International (FHI). Behavior Change—A Summary of Four Major theories.
- http://www.fhi.org/nr/rdonlyres/ei26vbslpsidmahhxc332vwo3g233xsgw22er3vofgvrfjvubwyzclvgjcbdgexyzl3msu4mn6xv5j/bccsummaryfourmajortheories.pdf(Accessed)Date: November 29, 2008
- Intervention-related cognitive versus social mediators of exercise adherence in the elderly.Am J Prev Med. 2002; 23: 80-86
- A social cognitive approach.in: Conner M Norman P Predicting Health Behaviour. Open University Press, New York, NY2005: 170-222
- Self-Efficacy: The Exercise of Control. Freeman, New York, NY1997
- Medication compliance and persistence: Terminology and definitions.Value Health. 2008; 11: 44-47
- Merck Frosst Pharmaceutical Report for the British Pharmaceutical Society on Medication Compliance. Merck Frosst Pharmaceutical, Montreal, Quebec, Canada1997
- A critical review of the “determinants” of patient compliance with therapeutic regimens.in: Sackett DL Haynes RB Compliance with Therapeutic Regimens. Johns Hopkins University Press, Baltimore, MD1976: 11-22
- Burke LE Ockene IS Compliance in Healthcare and Research. Futura Publishing Co, Inc, Armonk, NY2001
- Patient adherence to treatment: Three decades of research. A comprehensive review.J Clin Pharm Ther. 2001; 26: 331-342
- “Abandoned prescriptions”: A quantitative assessment of their cause.J Managed Care Pharm. 1995; 1: 193-199
- A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization.Am J Cardiol. 1997; 79: 58-63
- 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; 160: 2101-2107
- Interventions to enhance patient adherence to medication pre scriptions: Scientific review [published correction appears in JAMA. 2003;289:3242].JAMA. 2002; 288: 2868-2879
- Patient adherence and medical treatment out comes: A meta-analysis.Med Care. 2002; 40: 794-811
- Impact of medication nonadherence on coronary heart disease outcomes. A critical review.Arch Intern Med. 1997; 157: 1921-1929
- Special Report: Interventions to improve patient adherence with medications for chronic cardiovascular disorders.TEC Bull (Online). 2003; 20: 30-32
- A meta-analysis of the association between adherence to drug therapy and mortality.BMJ. 2006; 333: 15
- Cost-effectiveness of adherence-enhancing interventions: A quality assessment of the evidence.Ann Pharmacother. 2005; 39: 508-515
- Guyatt G Rennie D Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice. AMA Press, Chicago, IL2002
- Pharmaceutical care research and education project: Patient outcomes.J Am Pharm Assoc (Wash). 2001; 41: 411-420
- Effect of intervention through a pharmaceutical care program on patient adherence with prescribed once-daily atorvastatin.Pharmacoepidemiol Drug Saf. 2006; 15: 115-121
- Consequences of intermittent treatment for hypertension: The case for medication compliance and persistence.Am J Manag Care. 1998; 4: 1563-1568
- Pilot study to determine the impact of a multidisciplinary educational intervention in patients hospitalized with heart failure.Am Heart J. 2005; 150: 982
CONSORT Group. The CONSORT Statement.
- http://www.consortstatement.org/(Accessed)Date: November 29, 2008
- Clinical Epidemiology: How to Do Clinical Practice Research. 3rd ed. Lippincott Williams & Wilkins, Philadelphia, PA2006
- Analysis of Longitudinal Data. 2nd ed. Oxford University Press, Oxford, UK2002
- The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials.Ann Intern Med. 2001; 134: 657-662
- The revised CONSORT statement for reporting randomized trials: Explanation and elaboration.Ann Intern Med. 2001; 134: 663-694
- Biostatistics: The Bare Essentials. 3rd ed. Decker, Hamilton, Ontario, Canada2008
- Interventions to enhance medication adherence.Cochrane Database Syst Rev. 2005; 4 (CD000011. Update in: Cochrane Database System Rev. 2008;CD000011)
- Randomised Controlled Trials: A User's Guide. BMJ Books, London, UK1998
- Interpreting the Medical Literature. McGrawHill, New York, NY2006
- Effect of general practitioner education on adherence to antihypertensive drugs: Cluster randomised controlled trial.BMJ. 2007; 335: 1030
- Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London, UK2000
- Essential Evidence-Based Medicine. Cambridge University Press, New York, NY2004
- Pitfalls ofand controversies in cluster randomization trials.Am J Public Health. 2004; 94: 416-422
- Polypharmacy and medication adherence in patients with type 2 diabetes.Diabetes Care. 2003; 26: 1408-1412
- Intraclass correlation coefficients for cluster randomized trials in primary care: Data from the MRC Trial of the Assessment and Management of Older People in the Community.Control Clin Trials. 2002; 23: 409-421
- Intraclass correlation values for planning group randomized trials in education.Educ Eval Policy Anal. 2007; 29: 60-87
- Experimental and Quasi-Experimental Designs for Research. R. McNally, Chicago, IL1966
- A quasiexperimental study on a community-based stroke prevention programme for clients with minor stroke.J Clin Nurs. 2007; 16: 272-281
- Metabolic control of adults with type 2 diabetes mellitus through education and counseling.J Nurs Scholarsh. 2006; 38: 344-351
- High level of medication compliance and blood pressure control among hypertensive patients attending community pharmacies.J Soc Admin Pharm. 1990; 7: 78-83
- Compliance characteristics of 291 hypertensive patients from a rural midwest area.J Fam Pract. 1983; 17: 619-625
- Observational research methods. Research design II: Cohort, cross sectional, and case-control studies.Emerg Med J. 2003; 20: 54-60
- Organizational approaches to improve compliance.in: Burke LE Okene IS Compliance in Healthcare and Research. Futura Publishing Co, Armonk, NY2001: 81-90
- Adherence to medication.N Engl J Med. 2005; 353: 487-497
- Health Measurement Scales: A Practical Guide to Their Development and Use. 2nd ed. Oxford University Press, Oxford, UK1995
- Interventions for enhancing medication adherence.Cochrane Database Syst Rev. 2008; (CD000011)
- Patient compliance with drug treatment—new perspectives on an old problem.Clin Investig. 1992; 70: 163-166
- The assessment of refill compliance using pharmacy records: Methods, validity, and applications.J Clin Epidemiol. 1997; 150: 105-116
- Relationship between medication compliance and medical outcomes.Am J Health Syst Pharm. 1995; 52: S27-S29
Aardex. The Measurement.
- http://www.aardexgroup.com/aardex_index.php?group=aardex(Accessed)Date: February 9, 2009
- Methodological and conceptual issues in adherence.in: Myers LB Midence K Adherence to Treatment in Medical Conditions. Harwood Academic, Amsterdam, The Netherlands1998: 1-24
- Use of the Medication Event Monitoring System to estimate medication compliance in patients with schizophrenia.J Psychiatry Neurosci. 2001; 26: 325-329
- Adherence to prescribed antihypertensive drug treatments: Longitudinal study of electronically compiled dosing histories.BMJ. 2008; 336: 1114-1117
- The effect of microelectronic observation on compliance.Epilepsia. 1990; 31 (Abstract): 617-618
- Adherence to oral tamoxifen: A comparison of patient self-report, pill counts, and microelectronic monitoring.J Clin Oncol. 1993; 11: 1189-1197
- Critical comparison of novel and existing methods of compliance assessment during a clinical trial of an oral iron chelator.J Clin Pharmacol. 1994; 34: 944-949
- Electronic compliance monitoring in resistant hypertension: The basis for rational therapeutic decisions.J Hypertens. 2001; 19: 335-341
- The odds of the three nons when an aptly prescribed medicine isn't working: Non-compliance, non-absorption, non-response.Br J Clin Pharmacol. 2002; 54: 212-220
- Burke LE Ockene IS Compliance in Healthcare and Research. Futura Publishing Company, Armonk, NY2001
- Modern Epidemiology. 3rd ed. Lippincott Williams & Wilkins, Philadelphia, PA2008
- Biostatistics Part II Data Analysis and Methods: A Workbook Approach. Dept of Mathematics & Statistics, Acadia University, Wolfville, Nova Scotia, Canada2005
- Statistical First Aid: Interpretation of Health Research Data. Blackwell Scientific Publications, Boston, MA1992
- Density Estimation for Statistics and Data Analysis. Chapman & Hall/CRC, Boca Raton, FL1998
- Metric Development for Medication Compliance Using a Distribution Approach [master's thesis]. Acadia University, Wolfville, Nova Scotia, Canada2006
Statistics Department of the University of Auckland. The R Project for Statistical Computing 2007 [R Project Web site].
- http://www.r-project.org/(Accessed)Date: November 29, 2008
- Nonparametric Statistical Inference. 3rd ed. M Dekker, New York, NY1992
- Delay in filling the initial prescription for a statin: A potential early indicator of medication nonpersistence.Clin Ther. 2008; 30: 761-774
- Models for longitudinal data: A generalized estimating equation approach [published correction appears in Biometrics. 1989;45:347].Biometrics. 1988; 44: 1049-1060
- Compliance in an anti-hypertension trial: A latent process model for binary lon gitudinal data.Stat Med. 1998; 17: 357-370
- A Markov mixed effect regression model for drug compliance.Stat Med. 1998; 17: 2313-2333
- Modelling Survival Data in Medical Research. 1st ed. Chapman & Hall, London, UK; New York, NY1994
- Permutation Methods: A Distance Function Approach. Springer, New York, NY2001
- When drugs don't work: Economic assessment of enhancing compliance with interventions supported by electronic monitoring devices.PharmacoEconomics. 2007; 25: 621-635
- Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA Task Force report.Value Health. 2005; 8: 521-533
- Methods for integrating medication compliance and persistence in pharmacoeconomic evaluations.Value Health. 2007; 10: 498-509
- EQ-5D: A measure of health status from the EuroQol Group.Ann Med. 2001; 33: 337-343
The EuroQol Group. What is EQ5D? EQ-5D is standardised instrument for use as a measure of health outcome [EuroQol Group Web site].
- http://www.eurogol.org/(Accessed)Date: November 29, 2008
- Kind P Brooks R Rabin R EQ-5D Concepts and Methods: A Developmental History. Springer, Dordecht, The Netherlands2005
- The Health Utilities Index (HUI®): Concepts, measurement properties and applications.Health Qual Life Outcomes. 2008; 1 (Accessed): 1-54http://www.hglo.com/content/1/1/54Date: November 29, 2008
- Impact of medication adherence on hospitalization risk and healthcare cost.Med Care. 2005; 43: 521-530
Article info
Publication history
Accepted:
December 22,
2008
Identification
Copyright
© 2009 Excerpta Medica Inc. All rights reserved. Published by Elsevier Inc.
