@article{86fb8b552800460ca937b5f8338bf512,
title = "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",
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.",
keywords = "Anus neoplasms, HIV, Neoplasms, Patient reported outcome measures, Psychometrics, Quality of life",
author = "Atkinson, {Thomas M.} and Shelly Lensing and Lee, {Jeannette Y.} and Di Chang and Kim, {Soo Young} and Yuelin Li and Lynch, {Kathleen A.} and Andrew Webb and Holland, {Susan M.} and Lubetkin, {Erica I.} and Stephen Goldstone and Einstein, {Mark H.} and Stier, {Elizabeth A.} and Wiley, {Dorothy J.} and Ronald Mitsuyasu and Isabella Rosa-Cunha and Aboulafia, {David M.} and Shireesha Dhanireddy and Schouten, {Jeffrey T.} and Rebecca Levine and Edward Gardner and Jeffrey Logan and Hillary Dunleavy and Barroso, {Luis F.} and Gary Bucher and Jessica Korman and Benjamin Stearn and Wilkin, {Timothy J.} and Grant Ellsworth and Pugliese, {Julia C.} and Abigail Arons and Burkhalter, {Jack E.} and David Cella and Berry-Lawhorn, {J. Michael} and Palefsky, {Joel M.}",
note = "Funding Information: We gratefully acknowledge the contributions of study participants and the referral sites and their staff in meeting the study recruitment goals: We also acknowledge the contributions and support of Joseph Sparano, MD of the AMC; and Don Vena, Dustin Utt, Saron Aria, Carolina Novoa, and Maria Botello-Harbaum, Ph.D., of the ANCHOR Data Management Center of the EMMES Company, LLC. This research (AMC-A01/-A03; ClinicalTrials.gov: NCT02836522) was funded in part through 2 UM1 CA121947-09, 3U54CA137788-08S1, and a National Institutes of Health/National Cancer Institute Cancer Center Support Grant P30 CA008748, which provides partial support for the Patient-Reported Outcomes, Community Engagement, and Language Core Facility used in this investigation. The content of this research is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. Funding Information: This research (AMC-A01/-A03; ClinicalTrials.gov: NCT02836522) was funded in part through 2 UM1 CA121947-09, 3U54CA137788-08S1, and a National Institutes of Health/National Cancer Institute Cancer Center Support Grant P30 CA008748, which provides partial support for the Patient-Reported Outcomes, Community Engagement, and Language Core Facility used in this investigation. The content of this research is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. Funding Information: We gratefully acknowledge the contributions of study participants and the referral sites and their staff in meeting the study recruitment goals: We also acknowledge the contributions and support of Joseph Sparano, MD of the AMC; and Don Vena, Dustin Utt, Saron Aria, Carolina Novoa, and Maria Botello-Harbaum, Ph.D., of the ANCHOR Data Management Center of the EMMES Company, LLC. This research (AMC-A01/-A03; ClinicalTrials.gov: NCT02836522) was funded in part through 2 UM1 CA121947-09, 3U54CA137788-08S1, and a National Institutes of Health/National Cancer Institute Cancer Center Support Grant P30 CA008748, which provides partial support for the Patient-Reported Outcomes, Community Engagement, and Language Core Facility used in this investigation. The content of this research is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. Publisher Copyright: {\textcopyright} 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.",
year = "2023",
month = aug,
doi = "https://doi.org/10.1007/s11136-023-03391-4",
language = "English (US)",
volume = "32",
pages = "2293--2304",
journal = "Quality of Life Research",
issn = "0962-9343",
publisher = "Springer Netherlands",
number = "8",
}