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05-04-2023

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

Auteurs: 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 Levine, Edward 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

Gepubliceerd in: Quality of Life Research | Uitgave 8/2023

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.

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Titel: 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
Auteurs: 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 Levine
Edward 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
Publicatiedatum: 05-04-2023
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 8/2023
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-023-03391-4

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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

Methods

Results

Conclusion

Andere artikelen Uitgave 8/2023

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Bohn Stafleu van Loghum

Welkom bij Scalda & Bohn Stafleu van Loghum

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Abstract

Purpose

Methods

Results

Conclusion

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Hungarian PROMIS-29+2: psychometric properties and population reference values

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