Bohn, Kandace A.

Abstract Background: Epidemiologic studies commonly obtain important exposure and outcome information from patient self-report although these may be influenced by imperfect understanding and/or faulty recall. The Voyage Study is a large-scale, prospective cohort study of long-term health outcomes among participants with a valid multi-target stool DNA (mt-sDNA) test order (N=150, 047). The purpose of this analysis was to evaluate the validity of participant reported mt-sDNA tests, colorectal cancer (CRC), and/or aerodigestive cancers (ADC, including cancers of the head, neck, oral, esophageal, lung, liver, stomach, pancreas, anus) among respondents. Methods: Participants from across the Unites States enrolled in the study completing questionnaires at enrollment and 1 year. The year 1 questionnaire collected data on completion and outcome of their mt-sDNA test, follow up colonoscopies and other procedures as well as a diagnosis of CRC or ADC. The study team contacts those who reported either CRC or ADC for permission to obtain copies of medical records. Records are then reviewed by a trained nurse abstractor and evaluated for validity. Mt-sDNA test results were available from Exact Sciences. Results: At the time of this analysis, year 1 questionnaire data were available on 135, 035 participants. Abnormal mt-sDNA results (n=12, 928) were self-reported by 13, 420 participants with 96.3% accuracy. Of the 111, 556 self-reported normal results, 93.4% (n=104, 150) were reported correctly. The validation process for the Voyage Study is ongoing with 860 self-reported CRC and 318 self-reported aerodigestive cancer diagnoses to date. Complete data are available on 155 individuals with a self-report of a new CRC diagnosis and 63 individuals with a self-report of aerodigestive cancer. Abstraction confirmed 47% (n=73) of those reported as true CRC diagnoses. Participants were better at correctly reporting at least one aerodigestive cancer (73%, n=46). Discussion and Conclusions: Patient reported medical record validation poses a unique challenge in today’s world. The process of requesting participant authorization followed by institutional requests to release the medical records to the research team is slow and painstaking. We found that patients are able to correctly report their mt-sDNA tests but found a relatively low proportion of reported cancer diagnoses reported correctly. This underscores the need to continue to validate key outcomes rather than relying solely on participant responses. As the number of outcomes validated increases, the study team will look at a variety of social and economic factors to better understand what contributes to or hinders an accurate self-report. Citation Format: Emily J. Kirsch, Jessica A. Grimm, Shawn M. Stoddard, Winnie Z. Fan, Kandace A. Bohn, Kathleen J. Yost, Lila J. Finney Rutten, Janet E. Olson. Patient reported outcome validation within the Voyage Study cohort [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7354.

Abstract The Voyage Study is a large-scale, prospective cohort study of long-term health outcomes among participants with a valid multi-target stool DNA (mt-sDNA) test order. Recently, the Voyage Study achieved its enrollment target of 150,000 participants. The intent of this descriptive analysis is to provide baseline geographic and socio-demographic characteristics of Voyage Study participants to set the stage for future comparisons to the broader mt-sDNA user population. Participants were randomly selected from all persons in the U.S. or Puerto Rico who had a valid order for mt-sDNA screening during the enrollment period (10/18/2019 - 10/17/2023). Enrolled participants completed a baseline questionnaire that collected socio-demographic and health information. Participant characteristics and baseline survey answers were compared between regions using chi-square tests where appropriate. Regional geographic data was aggregated for the broader mt-sDNA user population during the enrollment period, though no formal comparisons were made between the broader population and the Voyage population at this time. Analyses were limited to 139,369 participants with available baseline questionnaire data. Voyage participants were more likely to reside in the Midwest, Northeast, or Southeast (29.9%, 22.5%, 22.6% respectively) and less likely to reside in the Southwest and West (11.6%, 13.4%). During the enrollment period, differential participation was also observed in the mt-sDNA user population, with the Midwest, Northeast, and Southeast having the greatest proportion (25.4%, 22.2%, 26.7%) and the Southwest and West having the lowest proportion of mt-sDNA users (13.8%, 11.9%). In the Voyage cohort, Midwest participants reported the lowest education attainment as characterized by years of school completed (14.1% high school or below, 59.2% college or greater), while participants in the West reported the highest education attainment (7.9% high school or below, 67.3% college or greater). The West also had the highest percentage of participants reporting an income of $100,000 or greater (51.6%), with the Southeast being the lowest (42.2%), as compared to the other regions. We report here early results of geographic and socio-demographic characteristics from a new research resource that will enable future analyses of health outcomes and behaviors in a population of mt-sDNA users. We observed that the greatest percentage of Voyage participants resided in the Midwest, Northeast, or Southeast, and that there was differential socio-demographic participant characteristics based on region. Future analyses will compare long-term healthcare outcomes and differences in colorectal cancer incidence and mortality between the broader mt-sDNA user population and the Voyage cohort. Citation Format: Allison M. Berry, Jessica A. Grimm, Christine R. Kirt, Emily J. Kirsch, Rachel E. Dixon, Winnie Z. Fan, Kandace A. Bohn, Jennifer St. Sauver, Kathleen J. Yost, Lila J. Finney Rutten, Janet E. Olson. U.S. Geographic and socio-demographic characteristics of Voyage Study participants [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3453.