Swipe om te navigeren naar een ander artikel
Jack E. Burkhalter is the senior author.
The members of The ANCHOR HRQoL Implementation Group are listed in Acknowledgement section.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
Nelson, R. A., Levine, A. M., Bernstein, L., Smith, D. D., & Lai, L. L. (2013). Changing patterns of anal canal carcinoma in the United States. Journal of Clinical Oncology, 31(12), 1569–1575. CrossRef
Shiels, M. S., Kreimer, A. R., Coghill, A. E., Darragh, T. M., & Devesa, S. S. (2015). Anal cancer incidence in the United States, 1977–2011: Distinct patterns by histology and behavior. Cancer Epidemiology, Biomarkers & Prevention, 24(10), 1548–1556. CrossRef
Palefsky, J. M. (2015). Screening to prevent anal cancer: Current thinking and future directions. Cancer Cytopathology, 123(9), 509–510. CrossRef
Chang, G. J., Berry, M. J., Jay, N., Palefsky, J. M., & Welton, M. L. (2002). Surgical treatment of high-grade anal squamous intraepithelial lesions. Diseases of the Colon & Rectum, 45(4), 453–458. CrossRef
Siegenbeek van Heukelom, M. L., Richel, O., Nieuwkerk, P. T., De Vries, H. J., & Prins, J. M. (2016). Health-related quality of life and sexual functioning of HIV-positive men who have sex with men who are treated for anal intraepithelial neoplasia. Disease Colon Rectum, 59(1), 42–47. CrossRef
Tinmouth, J., Raboud, J., Ali, M., Malloch, L., Su, D., Sano, M., et al. (2011). The psychological impact of being screened for anal cancer in HIV-infected men who have sex with men. Disease Colon Rectum, 54(3), 352–359. CrossRef
Burkhalter, J. E., Atkinson, T. M., Berry-Lawhorn, J., Goldstone, S., Einstein, M. H., Wilkin, T. J., Lee, J., et al. (2018). Initial development and content validation of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions. Value Health, 21(8), 984–992. CrossRef
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) Instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting concepts for a new PRO instrument. Value in Health, 14(8), 967–977. CrossRef
Patrick, D. L., Burke, L. B., Gwaltney, C. J., Leidy, N. K., Martin, M. L., Molsen, E., & Ring, L. (2011). Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 2—Assessing respondent Understanding. Value in Health, 14(8), 978–988. CrossRef
Willis, G. B. (2005). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks: Sage. CrossRef
US Department of Health and Human Services. (2009). Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. Accessed September 19, 2018, from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
Osaba, D., Rodrigues, G., Myles, J., Zee, B., & Pater, J. (1998). Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology, 16(1), 139–144. CrossRef
Cronbach, L. J. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16(3), 297–334. CrossRef
Tavakol, M., & Dennick, R. (2011). Making sense of Cronbach’s alpha. International Journal of Medical Education, 2, 53–55. CrossRef
Ng, S. S. M., Leung, W. W., Wong, C. Y. N., Hon, S. S. F., Mak, T. W. C., Ngo, D. K. Y., & Lee, J. F. Y. (2013). Quality of life after laparoscopic vs open sphincterpreserving resection for rectal cancer. World Journal of Gastroenterology, 19(29), 4764–4773. CrossRef
IBM Corp. Released 2017. IBM SPSS statistics for Windows, version 25.0. Armonk, NY: IBM Corp.
- 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. Atkinson
J. Michael Berry
Timothy J. Wilkin
Jack E. Burkhalter
the ANCHOR HRQoL Implementation Group
- Springer International Publishing