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

Abstract

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.

Associations of Community and Individual Social Determinants of Health With Medication Adherence in Patients With Atrial Fibrillation: A Retrospective Cohort Study

“…The authors found that fear of bleeding or other side effects and concerns about medication cost were the most frequently cited reasons for not refilling a prescription, representing an opportunity to better communicate the benefits and risks of OAC. 15 …”

“… 12 While adherence is frequently perceived as an issue of forgetfulness, studies show that unintentional and intentional nonadherence may be predicted by medication beliefs, financial barriers, education, economic circumstances, and sociodemographic factors. 13 , 14 , 15 More broadly, social determinants of health (SDoH) are defined as the “conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality‐of‐life outcomes and risks.” 16 SDoH associated with adverse health outcomes may also be associated with medication nonadherence. 17 Incremental increases in the number of an individual's social risk factors have been found to increase stroke risk in adults <75 years of age.…”

Association between VTE and antibiotic prophylaxis guideline compliance and patient-reported outcomes after total hip and knee arthroplasty: an observational study

“…For example, pre-operative patient expectations or patient activation, whereby compliant people may do other things that influence their outcomes after THA/TKA [ 15 , 70 ]. Surgeon factors that influence decisions regarding adherence [ 53 , 71 ], and the surgeon’s volume and surgical proficiency that may have more direct impacts on patient outcomes [ 72 ]. Different outcome measures and criteria used to determine compliance may yield different results.…”

“…We were interested to explore whether non-compliant VTE and antibiotic prophylaxis were associated with PROM after THA/TKA. Previous research has demonstrated that treatment adherence is associated with health outcomes, including patient satisfaction [53], quality of life [54], and nonadherence is associated with increased morbidity and costs [55]. Patients often lack clear understanding of their personal risk of VTE and SSI this may contribute to suboptimal levels of compliance with recommended prophylaxis [56,57].…”

Shared decision-making to improve medication adherence

“…4 Multiple factors related to the patient (low health literacy, knowledge gaps, decreased cognition, unpleasant adverse reactions), provider (limited time, use of complex regimens, ineffective communication, mistrust), and the healthcare system (limited access to care, poor care coordination, insuffi cient insurance coverage, cost) may impact adherence to prescribed treatment plans. 2,[4][5][6] Patients may not understand the benefi ts of prescribed…”