Grimm, Jessica A.

Background: Surgeons often recommend weight loss for patients with obesity before total knee arthroplasty (TKA). However, it is unknown whether preoperative weight loss affects outcomes. The goals of this study were to determine how many patients with obesity lost weight before TKA, to identify weight loss predictors, and to evaluate if preoperative weight loss affected postoperative outcomes. Methods: Among 23,726 primary TKAs performed between 2002 and 2019, we identified 3,665 patients who had a body mass index (BMI) of ≥30 kg/m 2 measured 1 to 24 months before surgery and had a weight measured at surgery. The mean patient age was 68 years, and 59% of patients were female. The mean patient BMI was 36 kg/m 2 . Univariable linear regressions evaluated weight loss predictors. Univariable and multivariable logistic regressions and Cox proportional hazards models evaluated the impact of preoperative weight change on discharge, operative time, periprosthetic joint infections (PJIs), complications, revisions, and reoperations. The mean follow-up was 6 years. Results: Overall, 20% of patients gained ≥5 pounds (1 pound = 0.45 kg), 39% maintained weight, 17% lost 5 to <10 pounds, 15% lost 10 to <20 pounds, and 9% lost ≥20 pounds before TKA. Male patients lost slightly more weight (−4.6 pounds) than female patients (−4.3 pounds) (p = 0.05). In univariable analyses, gaining >5 pounds was associated with increased odds of extended hospital length of stay (odds ratio [OR], 1.4; p = 0.01) and risk of complications (hazard ratio [HR], 1.7; p < 0.01). Losing 10 to <20 pounds was associated with increased risks of revision (HR, 2.0; p = 0.01), PJI (HR, 3.1; p < 0.01), and complications (HR, 1.6; p = 0.03). In multivariable analyses, compared with maintaining weight, losing 10 to <20 pounds was associated with an increased risk of PJI (HR, 2.6; p = 0.01), whereas gaining >5 pounds was associated with an increased risk of complications (HR, 1.5; p = 0.03). Conclusions: Few patients with obesity lost substantial weight before primary TKA, and reaching common preoperative weight loss goals was not associated with improved outcomes. Although a healthy weight is important for general health, weight loss before TKA may not be sufficient to improve postoperative outcomes for most patients with obesity. Level of Evidence: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

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.

Background: Many surgeons use body mass index (BMI) cutoffs when offering total hip arthroplasty (THA). However, little is known about who loses weight before THA, and if weight loss improves outcomes. This study determined how many patients lost weight before primary THA, identified predictors of preoperative weight loss, and evaluated whether preoperative weight loss was associated with improved outcomes. Methods: Among 53,038 primary THAs that were performed between 2002 and 2019, we identified 2,463 patients who had a BMI of ≥30 kg/m 2 (measured 1 to 24 months before surgery) and had their weight measured at the time of surgery. The mean age was 66 years; 47% were women. The mean BMI was 35 kg/m 2 . Nonparametric models evaluated potential associations with weight loss. Univariable and multivariable logistic regression and Cox proportional hazards models evaluated the impact of preoperative weight change on hospital length of stay, discharge disposition, operative time, periprosthetic joint infection (PJI), complications, revision, and reoperation. The mean follow-up was 5 years. Results: Overall, 17% of the patients gained >5 pounds (2.27 kg), 38% maintained their weight, 16% lost 5 to <10 pounds (4.54 kg), 17% lost 10 to <20 pounds (9.07 kg), and 12% lost ≥20 pounds before THA. Only 28% of patients with a preoperative BMI of ≥40 kg/m 2 achieved a BMI of <40 kg/m 2 by the time of surgery; those who did required a mean of 1.3 years to lose the weight. In multivariable analyses, there were no significant improvements in operative time, length of stay, and discharge disposition, or survivorship free of PJI, complication, revision, or reoperation for any weight-loss category when compared with those who maintained their weight. Conclusions: Only 12% of patients lost ≥20 pounds, and only 28% of patients with a BMI of ≥40 kg/m 2 achieved a BMI of <40 kg/m 2 before primary THA. There was no decrease in complications, revisions, or reoperations for any preoperative weight-loss category when compared with those who maintained their weight. While weight loss benefits overall health, the results of this study call into question whether preoperative weight loss alone is enough to reduce postoperative complications for most patients. Level of Evidence: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

Objective To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial. Design Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported. Results During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals. Conclusions Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data. Trial registration number NCT04124406.

Introduction/Objectives: Despite U.S. Preventive Services Task Force and American Cancer Society endorsement of primary HPV screening, limited published data shows low uptake. Primary Aim: Assess cervical cancer screening rates over time, particularly primary HPV test uptake, among patients in a midwestern practice. Secondary Aim: Evaluate associations between sociodemographics and screening adherence. Methods: Cross-sectional study. Qualifying subjects and type of screening test used were identified by applying ICD-9, ICD-10, lab test, and CPT codes to the Unified Data Platform. Sociodemographics were found through the electronic health record. Results: Primary HPV uptake represented <1% of annual screening from 1/2017 to 1/2022. On 1/1/2022, only 55% of 21 to 29 year old and 63% of 30 to 65 year old were up to date with screening among the studied population. For 21 to 29 year old, compared with White women, Black women were 28% less likely to be screened [RR = 0.72 (0.66-0.79)]. Compared with never-smokers, current smokers were 9% less likely to be screened [RR = 0.91 (0.87-0.96)], past smokers were 14% more likely [RR = 1.14 (1.09-1.2)]. Among 30 to 65 year old, compared with White women, Black women were 14% less likely to be screened [RR = 0.86 (0.81-0.9)]. Compared with never-smokers, current smokers were 21% less likely to be screened [RR = 0.79 (0.77-0.81)], past smokers were 6% less likely [RR = 0.94 (0.92-0.95)]. Jointly considering race, ethnicity, smoking status, Charlson score, and rurality, findings were similar for 21 to 29 year old; Black women were screened less than White women [RR = 0.73 (0.67-0.79)]; current smokers [RR = 0.9 (0.85-0.94)] and past smokers [RR = 1.12 (1.06-1.17)] were screened less than never smokers. For 30 to 65 year old, Black women were screened less than White women [RR = 0.83 (0.79-0.88)]; current smokers [RR = 0.8 (0.78-0.81)] and past smokers [RR = 0.95 (0.93-0.96)] were screened less than never smokers. Conclusions: Screening rates remained below the Healthy People 2030 goal of 79.2% over time, particularly for younger Black women and current smokers, with minimal use of primary HPV screening.

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.

Abstract Background: Adherence to recommended colorectal cancer (CRC) screening among US adults is below the public health target of 80%. The multi-target stool DNA assay (mt-sDNA) is a self-administered CRC screening test that may remove barriers to adherence. To improve understanding of long-term outcomes and the real-world impact of mt-sDNA screening, Mayo Clinic and Exact Sciences Laboratories are collaborating on a prospective cohort study of CRC incidence and mortality outcomes in individuals screened with mt-sDNA. We conducted an embedded experiment to identify the optimal incentive protocol for maximizing participation while managing study costs. Methods: A subset of the opt-in cohort was randomized to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year one of recruitment, as well as the incentive experiment, are reported. Results: During year 1 of the Voyage trial, a total of 600,258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26,429 (4.4%) opted in, 14,365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2,333 were randomized to the pre-incentive arm while 2,342 were randomized to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs. 52.0% for the post-consent incentive arm (1217/2432), p<0.001). A cost reduction was observed for the pre-consent incentive group. Higher response rates were seen among older vs. younger individuals, reflecting a common pattern in healthcare-related survey research participation. Age adjusted incidence rates for CRC have been shown to vary regionally; thus, adjustment for differential response by region will be important to ensure representativeness. Conclusions: CRC incidence and mortality vary with age; thus, adjusting for differential participation by age will be important in analyses of Voyage data. Pre-consent incentive option was associated with a higher participation rate and lower costs, and will be used for the remainder of the study recruitment. Trial Registration: NCT04124406; October 11th, 2019