Development and psychometric evaluation of ICIQ-PadPROM: A quality of life questionnaire to assess the treatment effect of absorbent continence products.

Abstract

To describe the development and evaluation of the ICIQ-PadPROM, the first self-reported quality of life questionnaire to assess the treatment effect of absorbent continence products, a new addition to the set of ICIQ modules providing international standardized assessment of lower pelvic dysfunction. Developed in four phases, question items semi-structured interviews were conducted with pad using men (n = 19), women (n = 6), with secondary analysis undertaken on transcripts (n = 15 women) from a previous study. Validity of a draft 67 item questionnaire was tested through cognitive debriefing interviews (n = 34) and postal survey (n = 239). Reliability was evaluated by 65 users with a 3 week interval between completions. Expert opinion and factor analysis were used to reduce the final questionnaire to 17 scored and 3 unscored items. The questionnaire comprises four scored domains: Pad design and Physical Effects (seven items), Psychological Effects (four items), Social Effects and Pad Leakage (three items) and Burden of Pad Use (three items), plus three unscored items. Levels of missing data ranged from 0 to 7.6%, with fair-to-moderate agreement. The Cronbach's alpha coefficient for all question items was 0.91 and factor analysis was undertaken to reduce redundancy. Existing incontinence-related outcome tools measure change in symptoms and quality of life impact. The ICIQ PadPROM questionnaire is the first to measure the impact of absorbent continence products on quality of life in the absence of any change in symptoms and will help policy-makers, clinicians, industry, and researchers to evaluate different products designs and materials for different patient populations.