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Reliability and between-group stability of a health-related quality of life symptom index for persons with anal high-grade squamous intraepithelial lesions: an AIDS Malignancy Consortium Study (AMC-A03)

  • Thomas M. AtkinsonEmail author
  • Joel Palefsky
  • Yuelin Li
  • Andrew Webb
  • J. Michael Berry
  • Stephen Goldstone
  • Rebecca Levine
  • Timothy J. Wilkin
  • Gary Bucher
  • David Cella
  • Jack E. Burkhalter
  • the ANCHOR HRQoL Implementation Group
Brief Communication

Abstract

Purpose

The Anal Cancer HSIL Outcomes Research (ANCHOR) trial aims to determine whether treating precancerous anal high-grade squamous intraepithelial lesions (HSIL), versus active surveillance, is effective in reducing anal cancer incidence in HIV-infected individuals. We evaluated the reliability (i.e., internal consistency, test–retest) and between-group stability of a 25-item ANCHOR Health-Related Symptom Index (A-HRSI).

Methods

ANCHOR participants at least 1-month post-randomization to treatment or active surveillance completed the A-HRSI via telephone. Participants were contacted 7–10 days later to complete the A-HRSI and a participant global impression of change (PGIC) item.

Results

Participants (n = 100) were enrolled (mean age = 51.4, 79% cisgender-male, 73% African American, 9% Hispanic) from five ANCHOR sites. Cronbach’s α was good for the physical symptoms (0.82) domain and fair for the physical impacts (0.79) and psychological symptoms (0.73) domains. Intraclass correlation coefficients were good for each of respective domains (i.e., 0.80, 0.85, and 0.82). There were no significant differences in PGIC between the treatment (n = 56) and active surveillance (n = 44) groups (F(1,98) = 2.03, p = 0.16).

Conclusions

The A-HRSI is able to reliably assess participant-reported symptoms and impacts of anal HSIL across a 7–10 days of timeframe. Future work will involve the establishment of construct and discriminant validity prior to inclusion in the full ANCHOR trial.

Keywords

Patient-reported outcomes Health-related quality of life Clinical outcome assessments Neoplasms ANCHOR trial 

Notes

Acknowledgements

The ANCHOR HRQoL Implementation Group members are Susan M. Holland, Jeannette Lee, Erika I. Lubetkin, Kathleen A. Lynch, Jeff Taylor, and Amanda Watsula-Morley.

Funding

This research (ClinicalTrials.gov: NCT02836522) was funded in part through 2 UM1 CA121947-09, 3U54CA137788-08S1, and the NIH/NCI Cancer Center Support Grant P30 CA008748-50, which provides partial support for the Patient-Reported Outcomes, Community-Engagement and Language Core Facility used in this investigation.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Thomas M. Atkinson
    • 1
    Email author
  • Joel Palefsky
    • 2
  • Yuelin Li
    • 1
  • Andrew Webb
    • 1
  • J. Michael Berry
    • 2
  • Stephen Goldstone
    • 3
  • Rebecca Levine
    • 4
  • Timothy J. Wilkin
    • 5
  • Gary Bucher
    • 6
  • David Cella
    • 7
  • Jack E. Burkhalter
    • 1
  • the ANCHOR HRQoL Implementation Group
  1. 1.Memorial Sloan Kettering Cancer CenterNew YorkUSA
  2. 2.University of California-San FranciscoSan FranciscoUSA
  3. 3.Laser Surgery CareNew YorkUSA
  4. 4.Montefiore Medical CenterNew YorkUSA
  5. 5.Weill Cornell MedicineNew YorkUSA
  6. 6.Anal Dysplasia Clinic MidwestChicagoUSA
  7. 7.Northwestern University Feinberg School of MedicineChicagoUSA

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