학술논문
Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03
Document Type
Original Paper
Author
Atkinson, Thomas M.; Lensing, Shelly; Lee, Jeannette Y.; Chang, Di; Kim, Soo Young; Li, Yuelin; Lynch, Kathleen A.; Webb, Andrew; Holland, Susan M.; Lubetkin, Erica I.; Goldstone, Stephen; Einstein, Mark H.; Stier, Elizabeth A.; Wiley, Dorothy J.; Mitsuyasu, Ronald; Rosa-Cunha, Isabella; Aboulafia, David M.; Dhanireddy, Shireesha; Schouten, Jeffrey T.; Levine, Rebecca; Gardner, Edward; Logan, Jeffrey; Dunleavy, Hillary; Barroso, Luis F.; Bucher, Gary; Korman, Jessica; Stearn, Benjamin; Wilkin, Timothy J.; Ellsworth, Grant; Pugliese, Julia C.; Arons, Abigail; Burkhalter, Jack E.; Cella, David; Berry-Lawhorn, J. Michael; Palefsky, Joel M.
Source
Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation - An Official Journal of the International Society of Quality of Life Research. :1-12
Subject
Language
English
ISSN
0962-9343
1573-2649
1573-2649
Abstract
Purpose: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI).Methods: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14–70 (T2), and 71–112 (T3) days following randomization.Results: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness.Conclusion: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making.