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 Journal Article
| Authors: | Atkinson, T. M.; Lensing, S.; Lee, J. Y.; Chang, D.; Kim, S. Y.; Li, Y.; Lynch, K. A.; Webb, A.; Holland, S. M.; Lubetkin, E. I.; Goldstone, S.; Einstein, M. H.; Stier, E. A.; Wiley, D. J.; Mitsuyasu, R.; Rosa-Cunha, I.; Aboulafia, D. M.; Dhanireddy, S.; Schouten, J. T.; Levine, R.; Gardner, E.; Logan, J.; Dunleavy, H.; Barroso, L. F.; Bucher, G.; Korman, J.; Stearn, B.; Wilkin, T. J.; Ellsworth, G.; Pugliese, J. C.; Arons, A.; Burkhalter, J. E.; Cella, D.; Berry-Lawhorn, J.; Palefsky, J. M. |
| Article 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: | PurposeTo 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). MethodsThe 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. ResultsConfirmatory 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. ConclusionA-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. (PsycInfo Database Record (c) 2023 APA, all rights reserved) |
| Keywords: | neoplasms; quality of life; patient reported outcome measures; hiv; psychometrics; anus neoplasms |
| Journal Title: | Quality of Life Research |
| Volume: | 32 |
| Issue: | 8 |
| ISSN: | 0962-9343 |
| Publisher: | Springer |
| Date Published: | 2023-08-01 |
| Start Page: | 2293 |
| End Page: | 2304 |
| ACCESSION: | 2023-63060-001 |
| DOI: | 10.1007/s11136-023-03391-4 |
| PROVIDER: | Ovid Technologies |
| PROVIDER: | psycinfo |
| PUBMED: | 37020153 |
| PMCID: | PMC10330891 |
| DOI/URL: | |
| Notes: | References -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF; MSK corresponding author is Thomas Atkinson -- Source: APA PsycInfo |
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