Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)

Background: Precancerous anal high-grade squamous intraepithelial lesions (HSIL) and its associated treatments have the potential to reduce health-related quality of life (HRQoL) in impacted individuals. The ANCHOR (ANal Cancer HSIL Outcomes Research) trial aims to determine whether treating anal HS...

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Main Authors: Thomas M. Atkinson, PhD, Joel Palefsky, MD, J. Michael Berry, MD, Stephen Goldstone, MD, Andrew Webb, Rebecca Levine, MD, Timothy J. Wilkin, MD, MPH, Gary Bucher, MD, David Cella, PhD, Jeannette Lee, PhD, Jeff Taylor, Yuelin Li, PhD, Jack Burkhalter, PhD
Format: Article
Language:English
Published: Elsevier 2018-06-01
Series:Papillomavirus Research
Online Access:http://www.sciencedirect.com/science/article/pii/S2405852118300508
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author Thomas M. Atkinson, PhD
Joel Palefsky, MD
J. Michael Berry, MD
Stephen Goldstone, MD
Andrew Webb
Rebecca Levine, MD
Timothy J. Wilkin, MD, MPH
Gary Bucher, MD
David Cella, PhD
Jeannette Lee, PhD
Jeff Taylor
Yuelin Li, PhD
Jack Burkhalter, PhD
author_facet Thomas M. Atkinson, PhD
Joel Palefsky, MD
J. Michael Berry, MD
Stephen Goldstone, MD
Andrew Webb
Rebecca Levine, MD
Timothy J. Wilkin, MD, MPH
Gary Bucher, MD
David Cella, PhD
Jeannette Lee, PhD
Jeff Taylor
Yuelin Li, PhD
Jack Burkhalter, PhD
author_sort Thomas M. Atkinson, PhD
collection DOAJ
description Background: Precancerous anal high-grade squamous intraepithelial lesions (HSIL) and its associated treatments have the potential to reduce health-related quality of life (HRQoL) in impacted individuals. The ANCHOR (ANal Cancer HSIL Outcomes Research) trial aims to determine whether treating anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in HIV-infected individuals. The present study sought to establish preliminary psychometric evidence of the 25-item ANCHOR Health-Related Symptom Inventory (A-HRSI). Methods: Eligible ANCHOR participants recruited within two-weeks post-treatment or randomization to active surveillance completed the A-HRSI and well-established legacy HRQoL measures (i.e., Functional Assessment of Cancer Therapy – General [FACT-G] and MD Anderson Symptom Inventory [MDASI]) via telephone. Construct validity was assessed using an exploratory factor analysis (EFA). Pearson correlations were then calculated between summed items within the resulting A-HRSI latent factors and legacy measure outcome subscales to establish convergent and divergent validity. Results: 200 participants were enrolled. EFA provided initial confirmation that the A-HRSI items are best represented by the proposed broad three-factor structure (e.g., physical symptoms, physical impacts, psychological symptoms). These three factors had fair to moderate Pearson correlations with FACT-G Total and MDASI Symptom Severity and Interference subscales. Conclusions: Preliminary psychometric evidence exists to support the construct validity of the A-HRSI, indicating this measure can capture disease- and treatment-related physical and psychological symptoms and physical impacts. Clinical responsiveness and Spanish-translation of this measure will be completed prior to ultimately deploying this measure in the ANCHOR trial to facilitate participant reporting of their HRQoL to inform clinical decision-making.
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spelling doaj.art-c15e3e2a9e284cbaa4fc4c5cc729aec02022-12-22T01:13:53ZengElsevierPapillomavirus Research2405-85212018-06-015S1S2Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)Thomas M. Atkinson, PhD0Joel Palefsky, MD1J. Michael Berry, MD2Stephen Goldstone, MD3Andrew Webb4Rebecca Levine, MD5Timothy J. Wilkin, MD, MPH6Gary Bucher, MD7David Cella, PhD8Jeannette Lee, PhD9Jeff Taylor10Yuelin Li, PhD11Jack Burkhalter, PhD12Memorial Sloan Kettering Cancer Center, New York, NYUniversity of California-San Francisco, CAUniversity of California-San Francisco, CALaser Surgery Care, New York, NYMemorial Sloan Kettering Cancer Center, New York, NYMontefiore Medical Center, New York, NYCornell University Medical Center, New York, NYAnal Dysplasia Clinic Midwest, Chicago, ILNorthwestern University Feinberg School of Medicine, Chicago, ILUniversity of Arkansas for Medical Sciences, Little Rock, ARAIDS Malignancy ConsortiumMemorial Sloan Kettering Cancer Center, New York, NYMemorial Sloan Kettering Cancer Center, New York, NYBackground: Precancerous anal high-grade squamous intraepithelial lesions (HSIL) and its associated treatments have the potential to reduce health-related quality of life (HRQoL) in impacted individuals. The ANCHOR (ANal Cancer HSIL Outcomes Research) trial aims to determine whether treating anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in HIV-infected individuals. The present study sought to establish preliminary psychometric evidence of the 25-item ANCHOR Health-Related Symptom Inventory (A-HRSI). Methods: Eligible ANCHOR participants recruited within two-weeks post-treatment or randomization to active surveillance completed the A-HRSI and well-established legacy HRQoL measures (i.e., Functional Assessment of Cancer Therapy – General [FACT-G] and MD Anderson Symptom Inventory [MDASI]) via telephone. Construct validity was assessed using an exploratory factor analysis (EFA). Pearson correlations were then calculated between summed items within the resulting A-HRSI latent factors and legacy measure outcome subscales to establish convergent and divergent validity. Results: 200 participants were enrolled. EFA provided initial confirmation that the A-HRSI items are best represented by the proposed broad three-factor structure (e.g., physical symptoms, physical impacts, psychological symptoms). These three factors had fair to moderate Pearson correlations with FACT-G Total and MDASI Symptom Severity and Interference subscales. Conclusions: Preliminary psychometric evidence exists to support the construct validity of the A-HRSI, indicating this measure can capture disease- and treatment-related physical and psychological symptoms and physical impacts. Clinical responsiveness and Spanish-translation of this measure will be completed prior to ultimately deploying this measure in the ANCHOR trial to facilitate participant reporting of their HRQoL to inform clinical decision-making.http://www.sciencedirect.com/science/article/pii/S2405852118300508
spellingShingle Thomas M. Atkinson, PhD
Joel Palefsky, MD
J. Michael Berry, MD
Stephen Goldstone, MD
Andrew Webb
Rebecca Levine, MD
Timothy J. Wilkin, MD, MPH
Gary Bucher, MD
David Cella, PhD
Jeannette Lee, PhD
Jeff Taylor
Yuelin Li, PhD
Jack Burkhalter, PhD
Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
Papillomavirus Research
title Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
title_full Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
title_fullStr Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
title_full_unstemmed Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
title_short Preliminary validation of a health-related quality of life symptom index for persons treated or actively monitored for anal HSIL (AMC –A02, -A03)
title_sort preliminary validation of a health related quality of life symptom index for persons treated or actively monitored for anal hsil amc a02 a03
url http://www.sciencedirect.com/science/article/pii/S2405852118300508
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