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

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) cli...

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Published in:	Quality of life research Vol. 32; no. 8; pp. 2293 - 2304
Main Authors:	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.
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01-08-2023 Springer Nature B.V
Subjects:	Anal Canal Anal cancer Anus Neoplasms - pathology Cancer HIV Infections - pathology Humans Medicine Medicine & Public Health Public Health Quality of Life - psychology Quality of Life Research Sociology Squamous Intraepithelial Lesions - diagnosis Squamous Intraepithelial Lesions - pathology Surveys and Questionnaires Validation studies Validity Patient reported outcome measures Psychometrics HIV Neoplasms Quality of life Anus neoplasms
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Author contributions Per International Committee of Medical Journal Editors (ICMJE) guidelines, all authors made substantial contributions to the conception or design of this manuscript; or the acquisition, analysis, or interpretation of data for the work; and drafted and/or revised the manuscript critically for important intellectual content; and reviewed and approved the final manuscript; and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Data analysis was performed by TMA, SL, JYL, DC, SYK, and YL. The first draft of the manuscript was written by TMA and all authors commented on and/or approved each version of the manuscript.
ISSN:	0962-9343 1573-2649
DOI:	10.1007/s11136-023-03391-4