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Value Health. 2018 Aug;21(8):984-992. doi: 10.1016/j.jval.2018.01.018. Epub 2018 Apr 11.

Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions.

Author information

1
University of California, San Francisco, CA, USA.
2
Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: atkinsot@mskcc.org.
3
Laser Surgery Care, New York, NY, USA.
4
Rutgers-New Jersey Medical School, Newark, NJ, USA.
5
Weill Cornell Medicine, New York, NY, USA.
6
University of Arkansas for Medical Sciences, Little Rock, AR, USA.
7
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
8
The City College of New York, New York, NY, USA.
9
AIDS Malignancy Consortium, USA.
10
Memorial Sloan Kettering Cancer Center, New York, NY, USA.
11
Montefiore Medical Center, New York, NY, USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02836522.

KEYWORDS:

ANCHOR trial; health-related quality of life; neoplasms; patient-reported outcomes

PMID:
30098677
PMCID:
PMC6093301
[Available on 2019-08-01]
DOI:
10.1016/j.jval.2018.01.018
[Indexed for MEDLINE]

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