Development and Validation of a Questionnaire to Measure Medication Adherence to Direct-Acting Agents in Patients with Hepatitis C

Abstract

This study aims to develop a new self-report tool (HCV-AD) measuring adherence factors, intentional or unintentional, during Hepatitis C Virus (HCV) treatment with direct-acting antivirals (DAA) aiming to achieve high efficacy, otherwise resulting in drug resistance and treatment failure. Two phases were conducted: in the first phase, items were generated based on an extensive literature review, and, in the second phase, a prospective cohort study was conducted using HCV patients from Gastroenterology Department from University County Hospital of Craiova, Romania (n = 222), to evaluate the validity and reliability of the questionnaire. A number of 19 items were generated following a systematic review and through expert opinion. The internal consistency reliability was evaluated using Cronbach’s alpha. The construct validity was assessed using correlations with two other instruments: visual analog scale (VAS) and medication possession ratio (MPR). The final questionnaire (HCV-AD10) was derived through exploratory factor analysis, with 82% of total variance explained. This instrument appeared as a reliable and valid measure for medication adherence, with Cronbach’s alpha (0.867) and significant high positive correlations between adherence scores calculated with HCV-AD10 and VAS (ρ = 0.61, p < 0.001) or with HCV-AD10 and MPR (ρ = 0.75, p < 0.001). This research would make a worthwhile contribution to HCV management.

Patient-reported outcome measures to detect intentional, mixed, or unintentional non-adherence to medication: a systematic review

“…Each measure or instrument was grouped into one of the three PROMs of non-adherence categories: table 1– intentional , I (n=44 of 59 instruments)5 6 14–55; or table 2– mixed, I/UI (n=13 of 59 instruments)55–67; or table 3– unintentional , UI (n=2 of 59 instruments) 68 69. Of the total 572 intentional criterion items, I=491, I=79, and I=2 were split into the intentional , mixed intentional/unintentional , and in the unintentional categories, respectively.…”

“…Each measure or instrument was grouped into one of the three PROMs of non-adherence categories: table 1-intentional, I (n=44 of 59 instruments) 5 6 14-55 ; or table 2-mixed, I/UI (n=13 of 59 instruments) [55][56][57][58][59][60][61][62][63][64][65][66][67] ; or Open access…”

“…PROMs of mixed intentional/unintentional (I/UI) non-adherence-n=13 of 59 measures, 138 items[55][56][57][58][59][60][61][62][63][64][65][66][67] …”

Factors Associated with the Refusal of Direct-Acting Antiviral Agents for the Treatment of Hepatitis C in Taiwan

“…In most countries, patients might receive DAA treatment from different insurance programs, in hospitals, with self-buy generic medications without any insurance records, or even in different countries. A new self-report tool (HCV-AD) was recently developed to measure factors of intentional or unintentional adherence during HCV treatment to avoid drug resistance and treatment failure [26]. The chart or program-based reviews may not determine DAA treatment or not correctly.…”