Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug;32(8):2293-2304.
doi: 10.1007/s11136-023-03391-4. Epub 2023 Apr 5.

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  1 , Shelly Lensing  2 , Jeannette Y Lee  2 , Di Chang  2 , Soo Young Kim  3 , Yuelin Li  3 , Kathleen A Lynch  3   4 , Andrew Webb  3 , Susan M Holland  3 , Erica I Lubetkin  5 , Stephen Goldstone  6 , Mark H Einstein  7 , Elizabeth A Stier  8 , Dorothy J Wiley  9 , Ronald Mitsuyasu  10 , Isabella Rosa-Cunha  11 , David M Aboulafia  12 , Shireesha Dhanireddy  13 , Jeffrey T Schouten  12   13 , Rebecca Levine  14 , Edward Gardner  15 , Jeffrey Logan  15 , Hillary Dunleavy  16 , Luis F Barroso  17 , Gary Bucher  18 , Jessica Korman  19 , Benjamin Stearn  20 , Timothy J Wilkin  21 , Grant Ellsworth  21 , Julia C Pugliese  22 , Abigail Arons  22 , Jack E Burkhalter  3 , David Cella  23 , J Michael Berry-Lawhorn  24 , Joel M Palefsky  24
Affiliations
Randomized Controlled Trial

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 et al. Qual Life Res. 2023 Aug.

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.

PubMed Disclaimer

Conflict of interest statement

Competing interest The authors have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
Study schema by phase and measures completed
Fig. 2
Fig. 2
Confirmatory factor model for the three-factor solution
See this image and copyright information in PMC

References

    1. Goedert JJ, Hosgood HD, Biggar RJ, Strickler HD, & Rabkin CS (2016). Screening for cancer in persons living with HIV infection. Trends in Cancer, 2(8), 416–428. 10.1016/j.trecan.2016.06.007. - DOI - PMC - PubMed
    1. Shiels MS, Islam JY, Rosenberg PS, Hall HI, Jacobson E, & Engels EA (2018). Projected cancer incidence rates and burden of incident cancer cases in HIV-infected adults in the United States through 2030. Annals of Internal Medicine, 168(12), 866–73. 10.7326/M17-2499. - DOI - PMC - PubMed
    1. Howlader N, Noone AM, Krapcho M, Miller D, Brest A, Yu M, et al. SEER cancer statistics review, 1975–2019, National Cancer Institute. Bethesda, MD based on Nov 2021 SEER data submission, posted to the SEER web site, April 2022. Retrieved July 27, 2022, from https://seer.cancer.gov/statistics-network/explorer/application.html
    1. Wang CJ, & Palefsky JM (2019). HPV-associated anal cancer in the HIV/AIDS patient. Cancer Treatment Research, 177, 183–209. 10.1007/978-3-030-03502-0_7. - DOI - PubMed
    1. St Laurent J, Luckett R, & Feldman S (2018). HPV vaccination and the effects on rates of HPV-related cancers. Current Problems in Cancer, 42(5), 493–506. 10.1016/j.currproblcancer.2018.06.004. - DOI - PubMed

Publication types

MeSH terms