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)
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).
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.
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).
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.
KeywordsPatient-reported outcomes Health-related quality of life Clinical outcome assessments Neoplasms ANCHOR trial
The ANCHOR HRQoL Implementation Group members are Susan M. Holland, Jeannette Lee, Erika I. Lubetkin, Kathleen A. Lynch, Jeff Taylor, and Amanda Watsula-Morley.
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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