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. 2021 Sep 9:15:1991-2007.
doi: 10.2147/PPA.S318030. eCollection 2021.

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

Sonal Ghura Mansukhani  1 , Elizabeth A MacLean  2 , Laura L Manzey  2 , Carl J Possidente  2 , Joseph C Cappelleri  2 , Linda S Deal  2
Affiliations

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

Sonal Ghura Mansukhani et al. Patient Prefer Adherence. .

Abstract

Purpose: 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: atrial fibrillation; content validity; medication adherence; osteoarthritis; patient-reported outcome.

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Conflict of interest statement

Elizabeth A MacLean, Laura L Manzey, Carl J Possidente, Joseph C Cappelleri, and Linda S Deal are employed by Pfizer, Inc (the study sponsor) and have received stock as part of their compensation. At the time of the study, Sonal Ghura Mansukhani was employed by Evidera, which collaborated on the study. She is now employed by Takeda. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Schematic of the instrument development flow.
Figure 2
Figure 2
Shared and unique adherence drivers.
Figure 3
Figure 3
Elements of the proximal-distal continuum of adherence drivers specific to AFib.
Figure 4
Figure 4
Elements of the proximal-distal continuum of adherence drivers specific to OA.
Figure 5
Figure 5
CIMA content evolution.
See this image and copyright information in PMC

References

    1. Cea-Calvo L, Marín-Jiménez I, de Toro J, et al. Different associations of intentional and non-intentional non-adherence behaviors with patient experience with healthcare and patient beliefs in medications: a survey of patients with chronic conditions. Patient Prefer Adherence. 2020;14:2439–2450. doi:10.2147/PPA.S281985 - DOI - PMC - PubMed
    1. Margolis Center. Medication adherence: landscape, strategies, and evaluation methods: meeting summary. 2019; Available from:https://healthpolicy.duke.edu/sites/default/files/2020-07/Medication%20A.... Accessed 3December, 2020.
    1. Lam WY, Fresco P. Medication adherence measures: an overview. Biomed Res Int. 2015;2015:217047. doi:10.1155/2015/217047 - DOI - PMC - PubMed
    1. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487–497. doi:10.1056/NEJMra050100 - DOI - PubMed
    1. Benjamin RM. Medication adherence: helping patients take their medicines as directed. Public Health Rep. 2012;127(1):2–3. doi:10.1177/003335491212700102 - DOI - PMC - PubMed