University of California, San Francisco, CA, USA.
Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Value Health. 2018 Aug;21(8):984-992. doi: 10.1016/j.jval.2018.01.018. Epub 2018 Apr 11.
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).
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.
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.
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.
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.
肛门癌是由致癌型人乳头瘤病毒引起的，在美国呈上升趋势。肛门癌预防的一个重点是筛查和治疗癌前高级别鳞状上皮内肛门病变（HSIL）。
使用定性技术开发 HSIL 相关健康症状指数，因为肛门 HSIL 及其治疗可能对健康相关生活质量（HRQOL）产生负面影响，目前尚无针对该病症和治疗的特定 HRQOL 测量方法。
专家咨询用于指导参与者一对一的概念启发访谈，以确定他们归因于肛门 HSIL 及其治疗的 HRQOL 方面。这产生了一份草案工具，该工具在独立的参与者样本中进行了管理，认知访谈技术评估了理解程度。
专家组确定了 18 个与肛门 HSIL 相关的概念。在 41 次概念启发访谈中，确定了 23 项代表身体症状、身体影响和心理症状的项目，构成了初始测量工具，然后在三轮认知访谈（n=45）中进行了评估。根据参与者的反馈，对问卷的几个方面进行了改进，根据专家/参与者的建议，每个方面增加了 3 项。由于理解不佳，有一个项目被删除，结果是一个 25 项的测量工具。
使用最先进的定性方法，我们已经确定了这种新工具（ANCHOR 肛门 HSIL 健康相关症状指数）的内容有效性。目前正在进行定量验证工作。开发这种工具的参与者驱动过程将有助于以参与者为中心评估治疗肛门 HSIL 或不治疗的发病率影响。
