Abstract
Objectives: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI. Methods: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable. Results: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). Conclusion: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Plain English Summary: Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care.
| Original language | English (US) |
|---|---|
| Article number | 108 |
| Journal | Journal of patient-reported outcomes |
| Volume | 6 |
| Issue number | 1 |
| DOIs | |
| State | Published - Dec 2022 |
Funding
RL has received grant funding from Medtronic. JMP serves as a Consultant with Antiva Biosciences, Vir Biotechnology, and Virion Therapeutics. JMP serves as a Scientific Advisory Board Speaker with Merck. All other authors have no disclosures. We gratefully acknowledge the contributions of study participants and the referral sites and their staff in meeting the study recruitment goals. We also acknowledge the contributions and support of Ron Mitsuyasu, MD and Joseph Sparano, MD of the AMC, and Don Vena, Julia C. Pugliese, MPH, Abigail Arons, Dustin Utt, and Saron Araia, of the AMC Operations & Data Management Center of the EMMES Corporation. This research (AMC-A04; ClinicalTrials.gov: NCT02836522) was funded in part through 2 UM1 CA121947-09, 3U54CA137788-08S1, and an NIH/NCI Cancer Center Support Grant P30 CA008748, which provides partial support for the Patient-Reported Outcomes, Community Engagement, and Language Core Facility used in this investigation. The content of this research is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Keywords
- Anal cancer
- Neoplasms
- Patient outcome assessment
- Patient reported outcome measures
- Quality of life
ASJC Scopus subject areas
- Health Informatics
- Health Information Management
