1 William S. Middleton Memorial Veterans Hospital, 2500 Overlook Terrace, Madison, WI, 53705, USA. email@example.com.
2 Department of Surgery, University of Wisconsin School of Medicine and Public Health, K6/100 Clinical Science Center, 600 Highland Ave, Madison, WI, 53792, USA. firstname.lastname@example.org.
3 Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, 411 W. Chapel Hill St., Suite 600, Durham, NC, 27701, USA.
4 Department of Population and Health Sciences, Duke University Medical Center, Duke Box 104023, 2200 West Main St, Office #771, Durham, NC, 27705, USA.
5 Department of Medicine, Duke University Medical Center, Durham, NC, USA.
6 Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, PA, USA.
7 Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, 27599, USA.
8 Department of Psychiatry, Duke University Medical Center, Durham, NC, USA.
9 Center for Behavioral Cardiovascular Health, Columbia University Medical Center, 622 W. 168th Street, PH9-311, New York, NY, 10032, USA.
10 Duke Clinical Research Institute, 2400 Pratt Street, Rm 0311 Terrace Level, Durham, NC, 27705, USA.
Nonadherence to direct-acting agents (DAAs) for hepatitis C (HCV) decreases viral response. To measure nonadherence to DAAs, a reliable, valid, and easily implemented method is needed.
The goals of this study were to refine a previously validated (in patients with hypertension) self-report measure of extent of nonadherence and reasons for nonadherence in the context of DAAs and to obtain initial evidence of content validity and reliability.
Phase I involved two focus groups with patients with HCV (n = 12) and one focus group with prescribers of HCV medications (n = 6) to establish content validity of reasons for nonadherence. Subsequent cognitive interviews with patients (n = 11) were conducted to refine items. Phase II was a prospective cohort study involving weekly administration of the refined measure by telephone to patients (n = 75) who are prescribed DAAs to evaluate reliability and consistency with viral response.
In the cohort study, internal consistency ranged from acceptable (α = .69) to very high (α = 1.00) across time points and was quite high on average (α = .91). Across the 75 participants, there were 895 measurement occasions; of those, nonadherence was reported on only 27 occasions (3%), all of which occurred in the first 12 weeks. These 27 occasions represented 19 (26%) different individuals. At 12 weeks, 1 (1%) of patients had a detectable HCV viral load; at 12-24 weeks posttreatment, 4 (5%) had a sustained viral response. Nonadherent patients reported an average of 1.41 reasons for nonadherence.
This multi-method study established content validity of reasons for nonadherence and reliability of extent of nonadherence. High rates of adherence and viral response were consistent with previous studies using other nonadherence measurement methods.