Abstract
Subcutaneous (SC) delivery of biologic therapies is typically self-administered via a prefilled syringe or an auto-injector. Auto-injector devices are designed to offer a more convenient and more consistent administration of the drug product. The Subcutaneous Administration Assessment Questionnaire (SQAAQ) is a novel, 12-item, self-administered questionnaire that assesses ease of use of SC delivery devices and patient confidence while using the device to administer an injection of drug. This study aimed to establish evidence of the content validity of the SQAAQ among patients with moderate to severe ulcerative colitis (UC).
A cross-sectional, US-based, qualitative study using a semi-structured discussion guide was conducted using online focus groups and one-on-one telephone interviews among adolescent (12–17 years (yrs)) and adult (18 yrs+) participants with diagnosis of moderate-to-severely active UC recruited from clinical sites and patient panels. Cognitive debriefing of the SQAAQ instructions, items, recall period, scoring algorithm, and response options was conducted to assess understanding and interpretation of the items. The SQAAQ instructs patients to evaluate the questions based on “to what extent do you agree that the device you just used has these features” on a 7-point Likert scale ranging from “strongly disagree” to “strongly agree”.
Thirty-one patients (n=27, 87% focus group; n=4, 13% telephone) participated in an interview. The majority were female (n=23, 74%); non-Hispanic or Latino (n=28, 90%); and White (n=22, 71%). Twelve (39%) were ≥18 yrs; 8 (26%) were 15–17 yrs; and 11 (35%) were 12–14-yrs. Administration of current medication use included: 48% on intravenous, 36% on SC, and 16% on oral. Adult and adolescent participants found the SQAAQ to be relevant, straight-forward, and easy to understand. Participants described the questionnaire as being ‘clear’, ‘detailed’, and felt as if the questionnaire included all the necessary items. All participants described the response options as ‘good’ and that they were able to select a response from a range of options. None of the participants had suggestions for changes to the response options. The confirmed conceptual framework (see Figure) for the SQAAQ depicts the 12 item concepts within 4 domains: ease of use (n=6 items), injection convenience (n=3 items), injection self-efficacy (n=2 items), and perceived self-efficacy (n=3 items).
Patient feedback confirms content validity of the SQAAQ and provides strong evidence that the concepts included in the SQAAQ are important to and well-understood by adults and adolescents with UC.
