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

Thomas M. Atkinson, Shelly Lensing, Jeannette Y. Lee, Di Chang, Soo Young Kim, Yuelin Li, Kathleen A. Lynch, Andrew Webb, Susan M. Holland, Erica I. Lubetkin, Stephen Goldstone, Mark H. Einstein, Elizabeth A. Stier, Dorothy J. Wiley, Ronald Mitsuyasu, Isabella Rosa-Cunha, David M. Aboulafia, Shireesha Dhanireddy, Jeffrey T. Schouten, Rebecca LevineEdward Gardner, Jeffrey Logan, Hillary Dunleavy, Luis F. Barroso, Gary Bucher, Jessica Korman, Benjamin Stearn, Timothy J. Wilkin, Grant Ellsworth, Julia C. Pugliese, Abigail Arons, Jack E. Burkhalter, David Cella, J. Michael Berry-Lawhorn, Joel M. Palefsky

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)2293-2304
Number of pages12
JournalQuality of Life Research
Issue number8
StatePublished - Aug 2023

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


  • Anus neoplasms
  • HIV
  • Neoplasms
  • Patient reported outcome measures
  • Psychometrics
  • Quality of life


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