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.
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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. |
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| Authors: | Atkinson, Thomas M. (AUTHOR), Lensing, Shelly (AUTHOR), Lee, Jeannette Y. (AUTHOR), Chang, Di (AUTHOR), Kim, Soo Young (AUTHOR), Li, Yuelin (AUTHOR), Lynch, Kathleen A. (AUTHOR), Webb, Andrew (AUTHOR), Holland, Susan M. (AUTHOR), Lubetkin, Erica I. (AUTHOR), Goldstone, Stephen (AUTHOR), Einstein, Mark H. (AUTHOR), Stier, Elizabeth A. (AUTHOR), Wiley, Dorothy J. (AUTHOR), Mitsuyasu, Ronald (AUTHOR), Rosa-Cunha, Isabella (AUTHOR), Aboulafia, David M. (AUTHOR), Dhanireddy, Shireesha (AUTHOR), Schouten, Jeffrey T. (AUTHOR), Levine, Rebecca (AUTHOR) |
| Source: | Quality of Life Research. Aug2023, Vol. 32 Issue 8, p2293-2304. 12p. 2 Diagrams, 5 Charts. |
| Subjects: | Anal cancer, Test validity, Confirmatory factor analysis, Patient reported outcome measures, Physical mobility |
| 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 164782797 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Atkinson%2C+Thomas+M%2E%22">Atkinson, Thomas M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lensing%2C+Shelly%22">Lensing, Shelly</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lee%2C+Jeannette+Y%2E%22">Lee, Jeannette Y.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chang%2C+Di%22">Chang, Di</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kim%2C+Soo+Young%22">Kim, Soo Young</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Li%2C+Yuelin%22">Li, Yuelin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lynch%2C+Kathleen+A%2E%22">Lynch, Kathleen A.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Webb%2C+Andrew%22">Webb, Andrew</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Holland%2C+Susan+M%2E%22">Holland, Susan M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lubetkin%2C+Erica+I%2E%22">Lubetkin, Erica I.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Goldstone%2C+Stephen%22">Goldstone, Stephen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Einstein%2C+Mark+H%2E%22">Einstein, Mark H.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Stier%2C+Elizabeth+A%2E%22">Stier, Elizabeth A.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wiley%2C+Dorothy+J%2E%22">Wiley, Dorothy J.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Mitsuyasu%2C+Ronald%22">Mitsuyasu, Ronald</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rosa-Cunha%2C+Isabella%22">Rosa-Cunha, Isabella</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Aboulafia%2C+David+M%2E%22">Aboulafia, David M.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dhanireddy%2C+Shireesha%22">Dhanireddy, Shireesha</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schouten%2C+Jeffrey+T%2E%22">Schouten, Jeffrey T.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Levine%2C+Rebecca%22">Levine, Rebecca</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Quality+of+Life+Research%22">Quality of Life Research</searchLink>. Aug2023, Vol. 32 Issue 8, p2293-2304. 12p. 2 Diagrams, 5 Charts. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Anal+cancer%22">Anal cancer</searchLink><br /><searchLink fieldCode="DE" term="%22Test+validity%22">Test validity</searchLink><br /><searchLink fieldCode="DE" term="%22Confirmatory+factor+analysis%22">Confirmatory factor analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+reported+outcome+measures%22">Patient reported outcome measures</searchLink><br /><searchLink fieldCode="DE" term="%22Physical+mobility%22">Physical mobility</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s11136-023-03391-4 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 12 StartPage: 2293 Subjects: – SubjectFull: Anal cancer Type: general – SubjectFull: Test validity Type: general – SubjectFull: Confirmatory factor analysis Type: general – SubjectFull: Patient reported outcome measures Type: general – SubjectFull: Physical mobility Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Atkinson, Thomas M. – PersonEntity: Name: NameFull: Lensing, Shelly – PersonEntity: Name: NameFull: Lee, Jeannette Y. – PersonEntity: Name: NameFull: Chang, Di – PersonEntity: Name: NameFull: Kim, Soo Young – PersonEntity: Name: NameFull: Li, Yuelin – PersonEntity: Name: NameFull: Lynch, Kathleen A. – PersonEntity: Name: NameFull: Webb, Andrew – PersonEntity: Name: NameFull: Holland, Susan M. – PersonEntity: Name: NameFull: Lubetkin, Erica I. – PersonEntity: Name: NameFull: Goldstone, Stephen – PersonEntity: Name: NameFull: Einstein, Mark H. – PersonEntity: Name: NameFull: Stier, Elizabeth A. – PersonEntity: Name: NameFull: Wiley, Dorothy J. – PersonEntity: Name: NameFull: Mitsuyasu, Ronald – PersonEntity: Name: NameFull: Rosa-Cunha, Isabella – PersonEntity: Name: NameFull: Aboulafia, David M. – PersonEntity: Name: NameFull: Dhanireddy, Shireesha – PersonEntity: Name: NameFull: Schouten, Jeffrey T. – PersonEntity: Name: NameFull: Levine, Rebecca IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: Aug2023 Type: published Y: 2023 Identifiers: – Type: issn-print Value: 09629343 Numbering: – Type: volume Value: 32 – Type: issue Value: 8 Titles: – TitleFull: Quality of Life Research Type: main |
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