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Improving Medication Adherence Research Reporting

European Society for Patient Adherence, Compliance and Persistence Medication Adherence Reporting Guideline

De Geest, Sabina, PhD, RN; Zullig, Leah L., PhD, MPH; Dunbar-Jacob, Jacqueline, PhD, RN; Hughes, Dyfrig, MRPharmS, PhD; Wilson, Ira B., MD, PhD; Vrijens, Bernard, PhD

Journal of Cardiovascular Nursing: May/June 2019 - Volume 34 - Issue 3 - p 199–200
doi: 10.1097/JCN.0000000000000572
DEPARTMENT: Editorial
Free

Sabina De Geest, PhD, RN Professor of Nursing and Chair, Department Public Health Institute of Nursing Science, Department Public Health, University of Basel, Basel, Switzerland, and Academic Centre for Nursing and Midwifery, Department of Public Health and Primary Care, KU Leuven, Belgium.

Leah L. Zullig, PhD, MPH Associate Professor, Durham Centre of Innovation to Accelerate Discovery and Practice, Transformation (ADAPT), Duke University School of Medicine, Durham, and USA Center for Health Services Research in Primary Care, Durham Veterans Affairs Health Care System, North Carolina.

Jacqueline Dunbar-Jacob, PhD, RN Professor of Nursing and Dean, School of Nursing, University of Pittsburgh, Pennsylvania.

Dyfrig Hughes, MRPharmS, PhD Professor of Pharmacoeconomics and Codirector of the Centre for Health Economics and Medicines Evaluation Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Gwynedd, North Wales, UK.

Ira B. Wilson, MD, PhD Chair, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.

Bernard Vrijens, PhD Invited Professor of Biostatistics, University of Liège, and Chief Executive Officer, AARDEX Group, Liège, Belgium.

The authors have no funding or conflicts of interest to disclose.

Note: Joint submission to the Journal of Cardiovascular Nursing and the European Journal of Cardiovascular Nursing.

This editorial was also published in the European Journal of Cardiovascular Nursing. The Journal of Cardiovascular Nursing is publishing it with permission of the copyright holder.

Correspondence Sabina De Geest, PhD, RN, Institute of Nursing Science, Department of Public Health, Faculty of Medicine, University of Basel, Bernoullistrasse 28, 4056 Basel, Switzerland (sabina.degeest@unibas.ch).

Medication nonadherence is a major public health issue and is associated with serious clinical and economic consequences. Because of its striking amplitude, medication adherence is a topic regularly addressed in the European Journal of Cardiovascular Nursing and the Journal of Cardiovascular Nursing.1–4 Indeed, nurses, as part of multidisciplinary healthcare teams, play a crucial role in medication adherence management in different healthcare settings. Nurses drive innovation in medication adherence management. Improvement in healthcare delivery is informed by evidence in the field of medication adherence, specifically an improved understanding of the prevalence, determinants/correlates, and consequences of medication nonadherence; advances in the measurement of medication adherence; and effective preventative or restorative medication adherence interventions.

Medication adherence research has increased substantially over the past 4 decades using observational, interventional, and implementation research designs. Despite these increased research efforts by many disciplines, including nursing, research has not resulted in the much-needed progress to tackle effectively medication nonadherence. Moreover, little is known about how to successfully translate effective adherence improving interventions into clinical practice. Progress has been hindered by variability in methodology and poor and/or incomplete reporting of medication adherence research (eg, inconsistent definitions, inadequate measurement of adherence outcomes, suboptimal analyses, insufficient description of intervention delivery settings, and scant theoretical underpinnings). Investment in reporting guidelines, for instance for randomized controlled trials (eg, Consolidated Standards of Reporting Trials statement), has shown to be effective in improving quality of reporting.5 Until recently, there were no specific guidelines to report medication adherence–specific aspects of research.

Under the auspices of the European Society for Patient Adherence, compliance and persistence (ESPACOMP) (http://www.espacomp.eu), an international panel of experts established an innovative and internationally validated set of reporting guidelines to enhance the quality of medication adherence research reporting.6,7 The international multidisciplinary expert Delphi panel resulted in the development of the European Society for Patient Adherence, compliance and persistence Medication Adherence Reporting Guideline (EMERGE). The EMERGE is built on a previously reported taxonomy,8 which defines medication adherence as “the process by which patients take their medications as prescribed” and divides adherence into 3 interrelated yet distinct phases: initiation, implementation, and persistence. Initiation refers to taking the first dose of a prescribed drug. Initiation is followed by the implementation phase, defined as “the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen from initiation until the last dose is taken.” Discontinuation refers to patients stopping the medication on their own initiative, taking no doses thereafter. Persistence expresses the time between initiation and the last dose. Issues with correct medication taking can occur in any of these 3 phases, for instance, late, incomplete, or noninitiation; suboptimal implementation of the dosing regimen (eg, late, skipped, extra, or reduced doses or drug holidays), or early discontinuation (nonpersistence). Each phase creates methodological challenges related to how medication use is operationally defined, measured, and analyzed.

The EMERGE consists of 4 minimum reporting criteria pertaining to (1) phases of medication adherence (cfr. ABC taxonomy), (2) operational definition for each phase(s), (3) measurement of each phase(s), and (4) results for each phase(s), as well as 17 additional items reflecting best reporting practice for the different sections of a research paper. The EMERGE includes items referring to theoretical underpinnings or implementation science model used, context information for the setting where the study was conducted, as well as description of possible implementation strategies used. The EMERGE complements existing reporting guidelines (eg, STrengthening the Reporting of OBservational studies in Epidemiology, Consolidated Standards of Reporting Trials, and Standards for Reporting Implementation Studies [StaRI] Statement)9 and provides researchers, authors, and journal editors with guidance on best practices for reporting observational and interventional studies relating to medication adherence.7 Using EMERGE, researchers improve the transparency and detail of reporting to enhance the field of medication adherence by making it possible to synthesize findings across study, with the ultimate goal of moving effective adherence support programs into healthcare policy and practice. By adopting EMERGE, biomedical journal editors can enhance the quality of medication adherence research published in their journals, thus contributing in the reduction of research waste.10

Nurses, being the largest and one of the most trusted groups of healthcare workers, can take up a leading role in developing, evaluating, and implementing innovative preventative and restorative approaches to support patients to adhere better in daily life. Overcoming the issues of medication nonadherence will require collaboration of all actors in the research and clinical enterprise. The evidence base to support this effort can only be strengthened only when we improve consistency in the reporting of medication adherence research. The EMERGE is a tool to do so. We welcome the authors, reviewers, and editors of European Journal of Cardiovascular Nursing and the Journal of Cardiovascular Nursing to use EMERGE in the future and to communicate with us their experiences in using EMERGE so we can continue optimizing this guideline in the future.

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