Development of a New Patient-Reported Medication Adherence Instrument: Concerns Influencing Medication Adherence

• Main Authors: Mansukhani SG, MacLean EA, Manzey LL, Possidente CJ, Cappelleri JC, Deal LS
• Format: Article
• Language: English
• Published: Dove Medical Press 2021-09-01
• Series: Patient Preference and Adherence
• Subjects: medication adherence; content validity; patient reported outcome; atrial fibrillation; osteoarthritis
• Online Access: https://www.dovepress.com/development-of-a-new-patient-reported-medication-adherence-instrument--peer-reviewed-fulltext-article-PPA

Sonal Ghura Mansukhani,1 Elizabeth A MacLean,2 Laura L Manzey,2 Carl J Possidente,2 Joseph C Cappelleri,2 Linda S Deal2 1Patient Centered Outcomes Research, Evidera, Waltham, Massachusetts, USA; 2Medical Outcomes Specialists (EAM, LLM, CJP); Patient Centered Outcome Assessment (LSD); Biostatistics (JCC), Pfizer Inc., New York, NY, USACorrespondence: Linda S Deal Email [e-mail]: The purpose of this research was to conceptualize and develop a tool for identifying persons who are, or are likely to be, non-adherent to medications prescribed by their healthcare provider(s) by identifying concerns that patients have regarding their treatments.Patients and Methods: The target populations were persons diagnosed with atrial fibrillation or osteoarthritis, who were prescribed anticoagulants or over-the-counter or prescription pain medications, respectively. In this two-stage, multi-year, qualitative research study, relevant concepts were explored, confirmed and refined. The focus was on non-adherence due to active (thus potentially modifiable) patient decisions to forego taking medications as prescribed.Results: The most common concerns among participants with atrial fibrillation were medication-related side effects and fear of bleeding. Participants with osteoarthritis were most concerned about short-term stomach problems and long-term kidney and liver side effects. The Concerns Influencing Medication Adherence (CIMA) instrument was developed based on these concerns and those identified in the literature. It is comprised of 16 items: a core set of 11 items potentially applicable to multiple disease states, 3 items specific to atrial fibrillation, and 2 items unique to osteoarthritis. The instrument is intended to be completed electronically, and publicly available for use in direct patient care in the United States or in population health management.Conclusion: To our knowledge, this is the first instrument focused on medication adherence that includes documented details of patient input as recommended by the United States Food and Drug Administration guidance. Patient input is considered a key component of content validity. In this research, for example, the concerns that patients have regarding their treatments can be expected to have affected past medication adherence and can potentially impact future adherence. Although applicability outside atrial fibrillation or osteoarthritis was not assessed, the general items may be useful in assessing adherence in other chronic diseases.Keywords: medication adherence, content validity, patient-reported outcome, atrial fibrillation, osteoarthritis