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; 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

doi:10.1007/s11136-023-03391-4

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, 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 LevineEdward 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

Research output: Contribution to journal › Article › peer-review

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.

Original language	English (US)
Pages (from-to)	2293-2304
Number of pages	12
Journal	Quality of Life Research
Volume	32
Issue number	8
DOIs	https://doi.org/10.1007/s11136-023-03391-4
State	Published - Aug 2023
Externally published	Yes

Keywords

Anus neoplasms
HIV
Neoplasms
Patient reported outcome measures
Psychometrics
Quality of life

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/s11136-023-03391-4

Cite this

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., ... Palefsky, J. M. (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. Quality of Life Research, 32(8), 2293-2304. https://doi.org/10.1007/s11136-023-03391-4

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. / Atkinson, Thomas M.; Lensing, Shelly; Lee, Jeannette Y. et al.
In: Quality of Life Research, Vol. 32, No. 8, 08.2023, p. 2293-2304.

Research output: Contribution to journal › Article › peer-review

Atkinson, TM, Lensing, S, Lee, JY, Chang, D, Kim, SY, Li, Y, Lynch, KA, Webb, A, Holland, SM, Lubetkin, EI, Goldstone, S, Einstein, MH, Stier, EA, Wiley, DJ, Mitsuyasu, R, Rosa-Cunha, I, Aboulafia, DM, Dhanireddy, S, Schouten, JT, Levine, R, Gardner, E, Logan, J, Dunleavy, H, Barroso, LF, Bucher, G, Korman, J, Stearn, B, Wilkin, TJ, Ellsworth, G, Pugliese, JC, Arons, A, Burkhalter, JE, Cella, D, Berry-Lawhorn, JM & Palefsky, JM 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', Quality of Life Research, vol. 32, no. 8, pp. 2293-2304. https://doi.org/10.1007/s11136-023-03391-4

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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 = "Publisher Copyright: {\textcopyright} 2023, The Author(s), under exclusive licence to Springer Nature Switzerland AG.",

year = "2023",

month = aug,

doi = "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",

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T1 - Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL)

T2 - AMC-A01/-A03

AU - Atkinson, Thomas M.

AU - Lensing, Shelly

AU - Lee, Jeannette Y.

AU - Chang, Di

AU - Kim, Soo Young

AU - Li, Yuelin

AU - Lynch, Kathleen A.

AU - Webb, Andrew

AU - Holland, Susan M.

AU - Lubetkin, Erica I.

AU - Goldstone, Stephen

AU - Einstein, Mark H.

AU - Stier, Elizabeth A.

AU - Wiley, Dorothy J.

AU - Mitsuyasu, Ronald

AU - Rosa-Cunha, Isabella

AU - Aboulafia, David M.

AU - Dhanireddy, Shireesha

AU - Schouten, Jeffrey T.

AU - Levine, Rebecca

AU - Gardner, Edward

AU - Logan, Jeffrey

AU - Dunleavy, Hillary

AU - Barroso, Luis F.

AU - Bucher, Gary

AU - Korman, Jessica

AU - Stearn, Benjamin

AU - Wilkin, Timothy J.

AU - Ellsworth, Grant

AU - Pugliese, Julia C.

AU - Arons, Abigail

AU - Burkhalter, Jack E.

AU - Cella, David

AU - Berry-Lawhorn, J. Michael

AU - Palefsky, Joel M.

PY - 2023/8

Y1 - 2023/8

N2 - 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.

AB - 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.

KW - Anus neoplasms

KW - HIV

KW - Neoplasms

KW - Patient reported outcome measures

KW - Psychometrics

KW - Quality of life

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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

Keywords

ASJC Scopus subject areas

UN SDGs

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