Initial development and content validation of a health-related symptom index for persons either treated or monitored fortreated or monitored for anal high-grade squamous intraepithelial lesions Journal Article


Authors: Burkhalter, J. E.; Atkinson, T. M.; Berry-Lawhorn, J.; Goldstone, S.; Einstein, M. H.; Wilkin, T. J.; Lee, J.; Cella, D.; Palefsky, J. M.; ANCHOR HRQOL Implementation Group
Article Title: Initial development and content validation of a health-related symptom index for persons either treated or monitored fortreated or monitored for anal high-grade squamous intraepithelial lesions
Abstract: Background: Anal cancer, caused by oncogenic types of human papillomavirus, is a growing problem in the United States. A key focus of anal cancer prevention has been screening for and treating precancerous high-grade squamous intraepithelial anal lesions (HSILs). Objectives: To develop a health-related symptom index for HSIL using qualitative techniques because anal HSIL and its treatment may have a negative impact on health-related quality of life (HRQOL), and no HRQOL measure specific to this condition and treatment currently exists. Methods: Expert consultation was used to guide one-on-one concept elicitation interviews with participants to identify HRQOL aspects they attribute to their anal HSIL and its treatment. This resulted in a draft instrument, which was administered to an independent participant sample, where cognitive interview techniques assessed comprehension. Results: Eighteen anal HSIL-related concepts were identified by the expert panel. Across the 41 concept elicitation interviews, 23 items representing physical symptoms, physical impacts, and psychological symptoms were identified to comprise the initial measure, which was then evaluated during three rounds of cognitive interviews (n = 45). Several questionnaire aspects were refined on the basis of participant input, with three additional items added per expert/participant recommendation. One item was removed because of poor comprehension, resulting in a 25-item measure. Conclusions: Using state-of-the-art qualitative methodology, we have established the content validity of this new instrument, the ANCHOR Anal HSIL Health-Related Symptom Index. Quantitative validation efforts are currently underway. The participant-driven process of developing this tool will facilitate a participant-centered evaluation of the impact on morbidity for treatment of anal HSIL or observation without treatment. © 2018 ISPOR–The Professional Society for Health Economics and Outcomes Research
Keywords: neoplasms; health-related quality of life; patient-reported outcomes; anchor trial
Journal Title: Value in Health
Volume: 21
Issue: 8
ISSN: 1098-3015
Publisher: Elsevier Science, Inc.  
Date Published: 2018-08-01
Start Page: 984
End Page: 992
Language: English
DOI: 10.1016/j.jval.2018.01.018
PROVIDER: scopus
PMCID: PMC6093301
PUBMED: 30098677
DOI/URL:
Notes: Article -- Export Date: 4 September 2018 -- Source: Scopus
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