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

Figures & data

Figure 1 Schematic of the instrument development flow.

Table 1 Inclusion Criteria for Both Stages of the Research

Stage 1. Content Exploration		Stage 2. Content Confirmation and Refinement
AFib	OA	AFib	OA
Self-report of a physician diagnosis of AFib	Self-report of a physician diagnosis of OA	Self-report of a physician diagnosis of AFib	Self-report of a physician diagnosis of OA and experience of OA in the hip or knee in the past month AND currently experiencing OA pain >5 on a 10-point scale^a
Age ≥18 years at screening	Age ≥30 years at screening	Age ≥18 years at screening	Age ≥30 years at screening
Self-report of currently taking or recently (past 12 months) non-persistent to DOACs^b (target 60% of participants) or VKAs (target 40% of participants)	Self-report of currently taking or ever taken a prescription medication for OA^c	Self-report of currently taking or ever having taken a DOAC^b for AFib	Self-report of currently taking or ever having taken a prescription medication for OA^c
Self-reported recent (past 12 months) medication non-adherence (target ≥50% of participants) or medication implementation errors once in the past week or ≥3 times in the past month (target ≥25% of participants)^d		Self-reported recent (past 12 months) medication non-adherence or medication-implementation errors once in the past week or ≥3 times in the past month^d

Notes: ^aIn response to the question: “Over the past month or 30 days, how would you rate your worst level of OA pain in your knee or hip on a scale of 0–10, where zero means No pain and 10 means Worst pain you can imagine? ^bApixaban, betrixaban, dabigatran, edoxaban, or rivaroxaban. ^cOA medications were described to potential participants as follows: analgesics, narcotic analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, injectable steroids (also known as glucocorticoids or steroids), or prescription topical treatment (eg, creams, gels, or ointments). ^dNon-adherence: failure to obtain the first prescribed refill and/or intentional non-persistence after the first prescribed refill. Medical implementation error: forgetfulness (especially evening doses), carelessness, self-initiated dose titration, or self-initiated “drug holidays”.

Abbreviations: AFib, atrial fibrillation; DOAC, direct-acting oral anticoagulant; OA, osteoarthritis; VKA, vitamin-K antagonist.

Figure 2 Shared and unique adherence drivers.

Figure 3 Elements of the proximal-distal continuum of adherence drivers specific to AFib.

Figure 4 Elements of the proximal-distal continuum of adherence drivers specific to OA.

Table 2 Demographic Characteristics

	Stage 1. Content Exploration		Stage 2. Content Confirmation and Refinement
Demographic Characteristics	AFib (N=30)	OA (N=36)	AFib (N=6)	OA (N=8)
Age (Years)
Mean (SD)	63.03 (9.64)	60.9 (9.37)	68.3 (10.75)	61.0 (11.88)
Years since diagnosis
Mean, years (range)	8.76 (1–40)	12.1 (1–30)	9.2 (4–15)	11.6 (2–30)
Gender, n (%)
Male	12 (40.0)	17 (47.2)	5 (83.3)	4 (50.0)
Female	18 (60.0)	19 (52.8)	1 (16.7)	4 (50.0)
Ethnicity, n (%)
Not Hispanic or Latino	24 (80.0)	32 (88.9)	5 (83.3)	8 (100)
Hispanic or Latino	4 (13.3)	2 (5.6)	1 (16.7)	0 (0.0)
Missing	2 (5.6)	2 (5.6)	0 (0.0)	0 (0.0)
Racial Background, n (%)^a
Black or African American	7 (23.3)	16 (44.4)	0 (0.0)	2 (25.0)
White	22 (73.3)	220 (55.6)	5 (83.3)	6 (75.0)
Other^b	1 (3.3)	1 (2.8)	1 (16.7)	0 (0.0)
Relationship Status, n (%)
Married/living with significant other	16 (53.3)	14 (38.9)	5 (83.3)	2 (25.0)
Widowed	1 (3.3)	3 (8.3	0 (0.0)	0 (0.0)
Divorced/separated	8 (26.7)	11 (30.6)	1 (16.7)	2 (25.0)
Single (never married)	5 (16.7)	8 (22.2)	0 (0.0)	4 (50.0)
Domestic Living Status, n (%)
Own home, apartment, or condominium	30 (100.0)	34 (94.4)	6 (100)	8 (100)
Other^c	0 (0.0)	2 (5.6)	0 (0.0)	0 (0.0)
Employment Status, n (%)^c
Employed full-time	9 (30.0)	16 (44.4)	2 (33.3)	5 (62.5)
Employed part-time	4 (13.3)	5 (13.9)	1 (16.7)	1 (12.5)
Unemployed	0 (0.0)	1 (2.8)	0 (0.0)	0 (0.0)
Retired	12 (40.0)	14 (38.9)	3 (50.0)	2 (25.0)
Disabled	4 (13.3)	1 (2.8)	0 (0.0)	0 (0.0)
Self-employed	2 (6.7)	1 (2.8)	1 (16.7)	0 (0.0)
Highest Level of Education, n (%)^c
High school/GED	3 (10.0)	2 (5.6)	2 (33.3)	0 (0.0)
Some college but no degree	8 (26.7)	11 (30.6)	0 (0.0)	2 (25.0)
2-year degree, vocational/technical/trade school	6 (20.0)	4 (11.1)	1 (16.7)	0 (0.0)
4-year university/college degree	8 (26.7)	13 (36.1)	1 (16.7)	4 (50.0)
Advanced degree	5 (16.7)	6 (16.7)	3 (50.0)	2 (25.0)
Health Insurance, n (%)^a
Commercial or employer-based health insurance	14 (46.7)	17 (47.2)	2 (33.3)	5 (62.5)
Medicaid	3 (10.0)	7 (19.4)	1 (16.7)	0 (0.0)
Medicare	15 (50.0)	13 (36.1)	3 (50.0)	3 (37.5)
Veterans’ health care	1 (3.3)	2 (5.6)	0 (0.0)	0 (0.0)
Uninsured	1 (3.3)	0 (0.0)	0 (0.0)	0 (0.0)

Notes: ^aResponses not mutually exclusive. ^b Other race: Stage1 AFib Latina (n=1), Stage 1 OA Mix/Latin (n=1); Stage 2 AFib Latina (n=1). ^c Other living conditions: Stage 1 OA rental home’ (n=1), Independent or retirement community (1).

Abbreviations: AFib, atrial fibrillation; GED, General Educational Development; OA, osteoarthritis; SD, standard deviation.

Table 3 Participant-Reported Clinical Characteristics

	Stage 1. Content Exploration		Stage 2. Content Confirmation and Refinement
Characteristic	AFib (N=30)	OA (N=36)	AFib (N=6)	OA (N=8)
Years since diagnosis
Mean, years (range)	8.76 (1–40)	12.1 (1–30)	9.2 (4−15)	11.6 (2–30)
Other medical conditions, n (%)^a
None	3 (10.0)	5 (13.9)	0 (0.0)	1 (12.5)
Anemia	2 (6.7)	3 (8.3)	0 (0.0)	0 (0.0)
Angina	0 (0.0)	1 (2.8)	1 (16.7)	0 (0.0)
Anxiety	1 (3.3)	8 (22.2)	1 (16.7)	1 (12.5)
Arthritis	13 (43.3)	0 (0.0)	0 (0.0)	0 (0.0)
Asthma	3 (10.0)	7 (19.4)	0 (0.0)	3 (37.5)
Cancer	1 (3.3)	1 (2.8)	1 (16.7)	0 (0.0)
COPD/emphysema	3 (10.0)	2 (5.6)	0 (0.0)	0 (0.0)
Depression	6 (20.0)	6 (16.7)	1 (16.7)	0 (0.0)
Diabetes mellitus	8 (26.7)	6 (16.7)	0 (0.0)	0 (0.0)
Hypercholesterolemia	10 (33.3)	13 (36.1)	3 (50.0)	4 (50.0)
Hypertension	17 (56.7)	14 (38.9)	3 (50.0)	2 (25.0)
Other^b	4 (13.3)	9 (25.0)	2 (33.3)	1 (12.5)
Current medications^a
AFib participants
DOACS	26 (86.7%)		6 (100%)
VKA oral tablets	3 (10.0%)		0 (0.0%)
OA participants
Cox-2 inhibitors		3 (8.3%)		0 (0.0%)
Injectable steroids		5 (13.9%)		2 (25.0%)
Narcotic analgesics		13 (36.1%)		1 (12.5%)
Non-narcotic analgesics		12 (33.3%)		5 (62.5%)
OTC NSAIDs		21 (58.3%)		5 (62.5%)
OTC topical treatments		14 (38.9%)		1 (12.5%)
RX NSAIDs		23 (63.9%)		4 (50.0%)
RX topical treatments		12 (33.3%)		3 (37.5%)

Notes: ^aAs reported by participants; Not mutually exclusive. ^b Other health conditions: Stage 1 AFib a-fib (sic; n=2), Sjogren’s (n=1), sleep apnea (n=1), osteopenia (n=1): Stage 1 OA Other health conditions: arthritis (n=1), coronary artery disease (n=1), fibromyalgia (n=2), glaucoma (n=1), knees (bone on bone; n=1), osteoarthritis (n=1), diverticulitis (n=1), ulcerative colitis (n=1), degenerative joint disease (n=1), acute allergic rhinitis (n=1), allergies (n=1), shine/tendonitis/lumbar (low back pain; n=1), hypothyroidism (n=1), renal insufficiency (n=1).

Abbreviations: COPD, chronic obstructive pulmonary disease; DOACS, direct oral anticoagulants; OTC, over-the-counter; RX, prescription; VKA, vitamin K antagonist.

Figure 5 CIMA content evolution.