Reducing patient burden to the FACT-Melanoma quality-of-life questionnaire

Abstract

Respondent burden has been defined as the cumulative demand placed on study participants related to the use of questionnaires or measurement instruments. The aim of this study was to reduce respondent burden associated with the Functional Assessment of Cancer Therapy-Melanoma (FACT-M), a melanoma-specific quality-of-life questionnaire, through item reduction using multiple psychometric approaches. Data for this study were pooled from three institutional review board-approved protocols. Poorly performing items were identified through distributional and correlation analyses, confirmatory factor analysis, reliability estimation, and Rasch-based approaches in a developmental dataset, and the reduced scale was assessed in a separate testing cohort. Validity, reliability, goodness of fit, and Rasch-based testing were carried out for both the full and the reduced scales. The clinical characteristics of the development (n=198) and testing (n=204) cohorts were similar. Three items identified through classical psychometric approaches and three items identified by Rasch-based analyses were excluded from the FACT-M subscale. Two additional items were identified for potential reduction but were ultimately maintained due to the adverse consequences to the psychometric integrity of the reduced instrument. The reduced FACT-M module contains 18 items. In addition to psychometric assessment, expert consultation was essential when examining areas of content redundancy and was critical when considering specific items for removal. This methodological approach reduced respondent burden by 25% while maintaining the psychometric integrity of the FACT-M.