Public Perspectives on Multi-Cancer Early Detection: A Qualitative Study.

BACKGROUND: Multi-cancer early detection tests (MCEDs) have the potential to identify over 50 types of cancer from a blood sample, possibly transforming cancer screening paradigms. Studies on the safety and effectiveness of MCEDs are underway, but there is a paucity of research exploring public views on MCEDs. We sought to explore public perspectives and understanding on the use of MCEDs in patient care. METHODS: We conducted a cross-sectional, qualitative study using one-on-one, semi-structured interviews. Residents of the United States aged 45-70 years old were recruited through a survey panel and purposively sampled to maximize racial diversity. Interviews explored understanding of MCEDs and perspectives on their use. Interviews were analyzed using thematic analysis with deductive coding and semi-quantification. RESULTS: Among 27 participants, mean age was 62 years (range 48-70) and most (63%) were non-white. Most participants had completed at least one cancer screening (89%). Participants had a positive impression of MCEDs (85%) and found the concept easy to understand (88%). They were enthusiastic about the convenience of MCEDs (30%) and thought they would improve "cancer outcomes" by looking for multiple cancers (70%) and facilitating early detection (33%). Participants emphasized the need to balance these benefits against potential harms, including inaccuracy (96%), cost (92%), test-related anxiety (56%), and lack of evidence of effectiveness (22%). Participants favored that MCEDs be delivered in primary care (93%). Participants worried that the potential benefits of MCEDs might not be equitably distributed (44%). CONCLUSIONS: Members of the US public in this study expressed an interest in using MCEDs but had concerns regarding cost, accuracy, and potential inequitable access to the tests. Findings suggest that MCEDs that are found to be safe and effective will be acceptable to patients as a part of primary care, and underscore public interest in improving this technology.

The influence of non-cancer-related risk factors on the development of cancer-related lymphedema: a rapid review.

Extensive research supports an evidence-base for cancer treatment-related risk factors, including extent of lymph node dissection and use of radiotherapy, as contributing to secondary lymphedema. Additionally, comorbidities, such as higher body mass index, and vascular-related conditions are identified to further augment risk. While social determinants of health (SDOH) and socioeconomic factors are widely regarded as influencing an individual's healthcare outcomes, including cancer risk and survival, these factors have not been explored as risk factors for developing secondary lymphedema. A rapid literature review explored the current evidence for SDOH as risk factors for lymphedema. Studies that were published over the last 10 years and that specifically analyzed social factors as variables associated with lymphedema were included. Studies that only characterized the social determinants of the study population were not included. Forty-nine studies were identified through a rapid literature review, and 13 studies that expressly analyzed social determinants as risk factors for secondary lymphedema were reviewed and extracted. All studies were conducted in patients with breast cancer-related lymphedema. Social risk factors included race, educational level, insurance type, and income level. These are consistent with the socioeconomic inequalities related to cancer survival. SDOH may influence the risk of developing cancer treatment-related health conditions like secondary lymphedema. Research trials studying cancer treatment-related conditions should collect consistent and robust data across social, behavioral, environmental, and economic domains and should analyze these variables to understand their contribution to study endpoints. Risk prediction modeling could be a future pathway to better incorporate social determinants, along with medical and co-morbidity data, to holistically understand lymphedema risk.

Impact of the COVID-19 Pandemic on Cancer Clinical Trials: Alliance for Clinical Trials in Oncology Experience (Alliance A152022).

Objective: The COVID-19 pandemic led to immediate changes in cancer clinical trial conduct. The primary aims of this study were to summarize the impact of the pandemic on Alliance for Clinical Trials in Oncology (Alliance) enrollment, protocol deviations, COVID-19 events (positive or presumptive-positive COVID test), and premature study discontinuation rates. Methods: Enrollment trends were examined from January 2019 (pre COVID-19 pandemic) through 2022. Data were captured for protocol deviations and premature treatment and study discontinuation events across all Alliance protocols using a centralized Medidata Rave database, and summarized from January 1, 2020, through June 30, 2022. Descriptive statistics and graphical techniques are used to summarize observed trends. Results: Overall enrollment across Alliance trials decreased during the COVID-19 pandemic and remained below pre-pandemic levels in 2022. Racial and ethnic demographics of enrolled patients did not change substantially. 4805 protocol deviations were reported on 2745 unique patients, with at least one protocol deviation reported by 618 sites and 77 unique trials. Commonly reported deviations were telemedicine visits (n=2167, 45%) and late/missed study procedures (n=2150, 45%). A total of 826 COVID-19 events were reported in 659 unique patients. Of an estimated 18,000 enrolled patients, only 68 withdrew from treatment and 45 withdrew from study due to COVID-19. Conclusion: A centralized COVID-19 database enabled a comprehensive assessment of the impact of the pandemic across Alliance trials. COVID-19 led to an immediate decline in enrollment across all patient populations. While the number of trials open to patient accrual remained stable, several large, adjuvant studies completed accrual during this period, which contributed to accrual decline. Telemedicine usage was notable, and both COVID-19 events and study discontinuation due to COVID-19 were rare.

Socio-demographic differences in the dietary inflammatory index from National Health and Nutrition Examination Survey 2005-2018: a comparison of multiple imputation versus complete case analysis.

OBJECTIVE: Studies using the dietary inflammatory index often perform complete case analyses (CCA) to handle missing data, which may reduce the sample size and increase the risk of bias. Furthermore, population-level socio-economic differences in the energy-adjusted dietary inflammatory index (E-DII) have not been recently studied. Therefore, we aimed to describe socio-demographic differences in E-DII scores among American adults and compare the results using two statistical approaches for handling missing data, i.e. CCA and multiple imputation (MI). DESIGN: Cross-sectional analysis. E-DII scores were computed using a 24-hour dietary recall. Linear regression was used to compare the E-DII scores by age, sex, race/ethnicity, education and income using both CCA and MI. SETTING: USA. PARTICIPANTS: This study included 34 547 non-Hispanic White, non-Hispanic Black and Hispanic adults aged ≥ 20 years from the 2005-2018 National Health and Nutrition Examination Survey. RESULTS: The MI and CCA subpopulations comprised 34 547 and 23 955 participants, respectively. Overall, 57 % of the American adults reported 24-hour dietary intakes associated with inflammation. Both methods showed similar patterns wherein 24-hour dietary intakes associated with high inflammation were commonly reported among males, younger adults, non-Hispanic Black adults and those with lower education or income. Differences in point estimates between CCA and MI were mostly modest at ≤ 20 %. CONCLUSIONS: The two approaches for handling missing data produced comparable point estimates and 95 % CI. Differences in the E-DII scores by age, sex, race/ethnicity, education and income suggest that socio-economic disparities in health may be partially explained by the inflammatory potential of diet.

Resiliency among older adults receiving lung cancer treatment (ROAR-LCT): A novel supportive care intervention for older adults with advanced lung cancer.

INTRODUCTION: Novel supportive care interventions designed for an aging population with lung cancer are urgently needed. We aimed to determine the feasibility of a novel supportive care physical therapy (PT) plus progressive muscle relaxation (PMR) intervention delivered to older adults with advanced lung cancer in the United States (US). MATERIALS AND METHODS: This clinical trial, Resiliency Among Older Adults Receiving Lung Cancer Treatment (ROAR-LCT: NCT04229381), recruited adults aged ≥60 years with unresectable stage III/IV non-small cell (NSCLC) or small cell lung cancer (SCLC) receiving cancer treatment at The James Thoracic Oncology Center (planned enrollment, N = 20). There were no exclusion criteria pertaining to performance status, laboratory values, prior cancer diagnoses, comorbidities, or brain metastases. Participants were evaluated by PT and psychology and given an exercise pedaler, resistance bands, a relaxation voice recording, and instructions at study initiation. Participants were evaluated in-person by PTs and psychologists at the start and end of the 12-session intervention, with the intervening sessions conducted via virtual health. Participants completed self-reported measures of functional status, symptoms, and mood longitudinally with the following instruments: EQ-5D-5L, Patient Health Questionnaire-9, and General Anxiety Disorder-7. PT assessments included the Short Physical Performance Battery (SPPB) and the two-minute walk test. Feasibility was defined as at least 60% of participants completing at least 70% of all intervention sessions. Optional gut microbiome samples and activity monitoring data (ActiGraph®) were also collected. RESULTS: The ROAR-LCT study concluded after consenting 22 patients. Among the 22 consented, 18 (81.8%) started the intervention; 11 participants (61.1%) completed at least 70% of all study sessions. All participants with SCLC completed the intervention. Reasons for withdrawal included progression of disease or hospitalization. The majority (88.9%) of patients who started were able to complete at least one virtual health session. Participants' functional status, SPPB, depression, and anxiety scores were stable from pre- to post-intervention. Participants who withdrew had worse baseline scores across domains. Seven microbiome and six ActiGraph® samples were collected. DISCUSSION: This is one of the first PT + PMR supportive care interventions using virtual health among older adults with advanced lung cancer to achieve feasibility in the US.

Representation of women in clinical trials supporting FDA-approval of contemporary cancer therapies.

Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well-represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database, clinicaltrials.gov, MEDLINE, and publicly available FDA-drug-reviews, we identified all pivotal (phase II and III) non-sex specific trials supporting FDA-approval of anticancer drugs (1998-2018). Observed-enrollment-rates were compared to expected-population-rates derived from concurrent US-National-Cancer-Institute's Surveillance-Epidemiology-and-End-Results (SEER) reported rates and US-Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation-to-prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex-specific analysis of efficacy and/or safety, irrespective of treatment-arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5 ± 4.0 years, 40.7% female, 79.1% biologic, targeted, or immune-based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men (p < .01). Altogether, women were under-represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight-average PPR of 0.91 (relative difference: -9.1%, p < .01). Women were most under-represented in gastric (PPR = 0.63), liver (PPR = 0.71), and lung (PPR = .81) cancer trials. Sex-based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613, p = .96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA-approved cancer drugs, women were frequently under-represented and sex-specific-efficacy and safety-outcomes were commonly not reported.

Risk factors for long COVID syndrome in postmenopausal women with previously reported diagnosis of COVID-19.

PURPOSE: Long COVID-19 syndrome occurs in 10-20 % of people after a confirmed/probable SARS-COV-2 infection; new symptoms begin within three months of COVID-19 diagnosis and last > 8 weeks. Little is known about risk factors for long COVID, particularly in older people who are at greater risk of COVID complications. METHODS: Data are from Women's Health Initiative (WHI) postmenopausal women who completed COVID surveys that included questions on whether they had ever been diagnosed with COVID and length and nature of symptoms. Long COVID was classified using standard consensus criteria. Using WHI demographic and health data collected at study enrollment (1993-98) through the present day, machine learning identified the top 20 risk factors for long COVID. These variables were tested in logistic regression models. RESULTS: Of n = 37,280 survey respondents, 1237 (mean age = 83 years) reported a positive COVID-19 test and 425 (30 %) reported long COVID. Symptoms included an array of neurological, cardio-pulmonary, musculoskeletal, and general fatigue, and malaise symptoms. Long COVID risk factors included weight loss, physical and mobility limitations, and specific heath conditions (e.g., history of heart valve procedure, rheumatoid arthritis). CONCLUSIONS: Knowledge of risk factors for long COVID may be the first step in understanding the etiology of this complex disease.

STEPS (Study To Examine Parent, Patient/Dental Provider Systems) to Prevent Human Papillomavirus (HPV)-Related Cancers: A Piloted Dental Patient and Provider Evaluation of Current and Future HPV Education.

Oropharyngeal human papillomavirus (HPV) cancers are prevalent, but HPV education in dental clinics is uncommon. The purpose of this study was to evaluate dental provider and patient knowledge from, attitudes towards, and preferences for HPV education, then assess perceptions of existing HPV educational materials for use at dental visits. Appalachian Ohio dental patients (n = 13) and general/pediatric dental providers (n = 10) completed an initial, close-ended survey on current HPV knowledge and HPV educational attitudes, participation, and resource preferences. Select individuals reviewed existing HPV educational videos and toolkits via virtual focus groups (n = 9) or independent review surveys (n = 6). Using a discussion guide, participants responded to overall, visual, auditory, and content satisfaction statements, orally (focus groups) or with Likert scales (independent reviews). Surveys were summarized with frequencies/percentages; transcripts were qualitatively coded to identify potential material modifications. Dental providers and patients were more comfortable with HPV and oral cancer education (87% and 96%, respectively) and screening (96%) than with HPV vaccine education (74%) and referrals (61%) during dental visits. Providers were neither sharing HPV educational materials (80%) nor initiating educational conversations with dental patients (100%). The American Cancer Society videos and the "Team Maureen" toolkit were the most liked resources (i.e., fewer negative/disagree statements) by all participant groups. Findings indicate that future dental HPV educational efforts should be informed by currently available materials. Additional interventions are needed to promote dental provider discussions and sharing of educational materials with patients to increase education and promotion of the HPV vaccine and reduce oropharyngeal cancers.

The FITNESS study: longitudinal geriatric assessment, treatment toxicity, and biospecimen collection to assess functional disability among older adults with lung cancer.

Introduction: Older adults with chronic disease prioritize functional independence. We aimed to describe the feasibility of capturing functional disability and treatment toxicity among older adults with lung cancer using a longitudinal comprehensive geriatric assessment (CGA) and molecular biomarkers of aging. Methods: This prospective study included adults ≥60 years with any newly diagnosed non-small-cell lung cancer. Participants were recruited from central Ohio (2018-2020). Study assessments included the Cancer and Aging Research Group CGA (CARG-CGA), short physical performance battery (SPPB), and the blessed orientation-memory concentration (BOMC) test at baseline, 3, 6, and 12 months. Activities of daily living (ADLs) and instrumental ADLs (IADLs), quality of life (QoL, PROMIS 10), and treatment toxicity were captured monthly. Stool and blood were collected to characterize the gut microbiome and age-related blood biomarkers. Results: This study enrolled 50 participants with an average age of 71.7 years. Ninety-two percent of participants were Caucasian, 58% were male, and all were non-Hispanic. Most had advanced stage (stage III/IV: 90%; stage I/II: 10%), with adenocarcinoma the predominant histologic subtype (68% vs. 24% squamous). First-line treatments included chemotherapy (44%), immune checkpoint inhibitors (ICIs, 22%), chemotherapy and ICIs (30%), or tyrosine kinase inhibitors (4%). The median baseline CARG toxicity score was 8 (range 2-12). Among patients with treatment-related toxicity (n = 49), 39 (79.6%) cases were mild (grade 1-2), and 10 (20.4%) were moderate to severe (≥ grade 3). Treatment toxicity was greater among those with a CARG score ≥8 (28.0% vs. 13.6%). Higher IADL independence, QoL, and SPPB scores at baseline were positively associated with Candidatus Gastranaerophilales bacterium, Lactobacillus rogosae, and Enterobacteria phage P4. Romboutsia ilealis, Streptococcus, and Lachnoclostridium sp An138 and T cell lag3 and cd8a were associated with worse IADLs, QoL, and SPPB scores at baseline. Discussion: A longitudinal CGA and biomarker collection is feasible among older adults undergoing lung cancer treatment. Gut microbe and T cell gene expression changes correlated with subjective and objective functional status assessments. Future research will test causality in these associations to improve outcomes through novel supportive care interventions to prevent functional disability.

A scoping review of the evidence on survivorship care plans among minority, rural, and low-income populations.

PURPOSE: Despite recent advances in cancer control and the number of cancer survivors increasing substantially over the past years, some cancer survivors continue to experience disparities due to barriers to recommended survivorship care. The use of survivorship care plans (SCPs) may be a way to help care for these individuals and their respective issues after they complete their primary treatment. The purpose of this scoping review is to understand the evidence on SCPs among minority, rural, and low-income populations: groups that experience disproportionately poorer cancer health outcomes. METHODS: Computer-based searches were conducted in four academic databases. We included peer-reviewed studies published in the English language and conducted in the USA. We systematically extracted information from each paper meeting our inclusion criteria. RESULTS: Our search identified 45 articles. The 4 major themes identified were (1) disparities in the receipt of SCPs where populations experience unmet needs; (2) benefits of SCPs, including improved care coordination and self-management of cancer; (3) needs and preferences for survivorship care; and (4) barriers and facilitators to using SCPs. CONCLUSIONS: Despite the potential benefits, underserved cancer survivors experience disparities in the receipt of SCPs and continue to have unmet needs in their survivorship care. Survivorship care may benefit from a risk-stratified approach where SCPs are prioritized to survivors belonging to high-risk groups. IMPLICATIONS FOR CANCER SURVIVORS: SCPs are a tool to deliver quality care for cancer survivors. While evidence is mixed on SCPs' benefits among the general population, SCPs show promise for underserved populations when it comes to proximal outcomes that contribute to disparities.

Factors Influencing Implementation of the Commission on Cancer's Breast Synoptic Operative Report (Alliance A20_Pilot9).

BACKGROUND: The technical aspects of cancer surgery have a significant impact on patient outcomes. To monitor surgical quality, in 2020, the Commission on Cancer (CoC) revised its accreditation standards for cancer surgery and introduced the synoptic operative reports (SORs). The standardization of SORs holds promise, but successful implementation requires strategies to address key implementation barriers. This study aimed to identify the barriers and facilitators to implementing breast SOR within diverse CoC-accredited programs. METHODS: In-depth semi-structured interviews were conducted with 31 health care professionals across diverse CoC-accredited sites. The study used two comprehensive implementation frameworks to guide data collection and analysis. RESULTS: Successful SOR implementation was impeded by disrupted workflows, surgeon resistance to change, low prioritization of resources, and poor flow of information despite CoC's positive reputation. Participants often lacked understanding of the requirements and timeline for breast SOR and were heavily influenced by prior experiences with templates and SOR champion relationships. The perceived lack of monetary benefits (to obtaining CoC accreditation) together with the significant information technology (IT) resource requirements tempered some of the enthusiasm. Additionally, resource constraints and the redirection of personnel during the COVID-19 pandemic were noted as hurdles. CONCLUSIONS: Surgeon behavior and workflow change, IT and personnel resources, and communication and networking strategies influenced SOR implementation. During early implementation and the implementation planning phase, the primary focus was on achieving buy-in and initiating successful roll-out rather than effective use or sustainment. These findings have implications for enhancing standardization of surgical cancer care and guidance of future strategies to optimize implementation of CoC accreditation standards.

Racial/Ethnic Disparities in HRQoL and Associated Risk Factors in Colorectal Cancer Survivors: With a Focus on Social Determinants of Health (SDOH).

PURPOSE: This study aimed to understand how health-related quality of life (HRQoL) differs by race/ethnicity in colorectal (CRC) survivors. We aimed to 1) examine racial/ethnic disparities in HRQoL, and 2) explore the roles of social determinants of health (SDOH) risk factors for HRQoL differ by racial/ethnic groups. METHODS: In 2,492 adult CRC survivors using Behavioral Risk Factor Surveillance System (BRFSS) survey data (from 2014 to 2021, excluding 2015 due to the absence of CRC data), we used the Centers for Disease Control and Prevention (CDC) HRQoL measure, categorized into "better" and "poor." Multivariate logistic regressions with prevalence risk (PR) were employed for our primary analyses. RESULTS: Compared with non-Hispanic Whites (NHW), non-Hispanic Blacks (NHB) (PR = 0.61, p = .045) and Hispanics (PR = 0.32, p < .001) reported worse HRQoL in adjusted models. In adjusted models, unemployed/retired and low-income levels were common risk factors for worse HRQoL across all comparison groups (NHW, NHB, non-Hispanic other races, and Hispanics). Other SDOH associated with worse HRQoL include divorced/widowed/never married marital status (non-Hispanic other races and Hispanics), living in rural areas (NHW and NHB), and low education levels (NHB and Hispanics). Marital status, education, and employment status significantly interacted with race/ethnicity, with the strongest interaction between Hispanics and education (PR = 2.45, p = .045) in adjusted models. CONCLUSION: These findings highlight the need for culturally tailored interventions targeting modifiable factors (e.g., social and financial supports, health literacy), specifically for socially vulnerable CRC survivors, to address the disparities in HRQoL among different racial/ethnic groups.

Association between sociodemographics and change in alcohol or tobacco use behaviors during the COVID-19 pandemic.

OBJECTIVE: To examine the association between various sociodemographic factors with alcohol and tobacco use behaviors during the COVID-19 pandemic. METHODS: Participants from Ohio and Indiana were asked to participate in the 'Impact of COVID-19 on the Cancer Continuum Consortium' study (N = 32,989) from June-November 2020. Those who completed the survey and responded to key study questions were included (n = 5,374). Participants were asked about the frequency and type of alcohol and tobacco product used. Multivariable logistic regression was conducted to determine factors associated with the impact of COVID-19 on change in alcohol and/or tobacco use. RESULTS: Mean age was 57 years old, 68% were female, 90% non-Hispanic white, 75% married, and 31% lived in rural counties. Out of 5,374 participants, 53% used alcohol-only (n = 2,833), 5% used tobacco-only (n = 255), 7% used both alcohol and tobacco (n = 395), and 35% used neither alcohol nor tobacco (n = 1,891). Urban county of residence (vs. rural) was associated with an increase in alcohol-use (p = 0.0001), change in alcohol products (p = 0.023), and an increase in tobacco use (p = 0.05). Among alcohol-only users, those who were younger (OR = 0.97), female (OR = 1.58), married (OR = 1.69), of high socioeconomic status (OR = 1.99), residing in urban counties (OR = 1.65), and had elevated financial (OR = 1.06) and employment concerns (OR = 1.28) were significantly more likely to report increased alcohol-use. Similarly, among tobacco users, those who were younger (OR = 0.97), female (OR = 2.79), married (OR = 2.16) or divorced (OR = 2.83), and had higher levels of neighborhood disadvantage (OR = 2.19) were significantly more likely to report increased tobacco-use. CONCLUSIONS: Findings suggest targeted intervention and prevention strategies for young, female participants with elevated financial and employment concerns during the COVID-19 pandemic are necessary to mitigate risks associated with higher odds of alcohol and tobacco use. Our findings on alcohol and tobacco use may be a result of the unique social and economic influence of the pandemic on women.

Patient Navigation Plus Tailored Digital Video Disc Increases Colorectal Cancer Screening Among Low-Income and Minority Patients Who Did Not Attend a Scheduled Screening Colonoscopy: A Randomized Trial.

BACKGROUND: Up to 50% of people scheduled for screening colonoscopy do not complete this test and no studies have focused on minority and low-income populations. Interventions are needed to improve colorectal cancer (CRC) screening knowledge, reduce barriers, and provide alternative screening options. Patient navigation (PN) and tailored interventions increase CRC screening uptake, however there is limited information comparing their effectiveness or the effect of combining them. PURPOSE: Compare the effectiveness of two interventions to increase CRC screening among minority and low-income individuals who did not attend their screening colonoscopy appointment-a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based PN compared to usual care. METHODS: Patients (n = 371) aged 45-75 years at average risk for CRC who did not attend a screening colonoscopy appointment were enrolled and were randomized to: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. CRC screening outcomes were from electronic medical records at 12 months. Multivariable logistic regression analyses were used to study intervention effects. RESULTS: Participants randomized to tailored DVD plus PN were four times more likely to complete CRC screening compared to usual care and almost two and a half times more likely than those who were sent the DVD alone. CONCLUSIONS: Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend their screening colonoscopy appointments and has potential for wide dissemination.

Up to half of people scheduled for a screening colonoscopy do not complete this test. There is a need for interventions to improve knowledge about colorectal cancer (CRC) screening, enhance access to screening by offering alternative test options, foster skills for completing screening, and mitigate barriers. The purpose of this study was to compare the effects of two interventions aimed at increasing CRC screening­a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based patient navigation (PN)­for patients who had not completed a scheduled screening colonoscopy. We enrolled 371 patients aged 45­75 years who had no CRC risk factors other than age, who were scheduled for a screening colonoscopy but did not attend their appointment. Participants were randomized to receive either: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. Those who received the tailored DVD plus PN were four times more likely to complete CRC screening with stool test or colonoscopy compared to usual care. Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend a scheduled screening colonoscopy appointment.

The impact of metabolic syndrome severity on racial and ethnic disparities in Metabolic Dysfunction-Associated Steatotic Liver Disease.

BACKGROUND & AIMS: Previous studies have examined the effects of metabolic syndrome (MetS) rather than its severity on race and ethnic disparities in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). We used the MetS severity score, a validated sex-race-ethnicity-specific severity measure, to examine the effects of race/ethnicity on the association between MetS severity and MASLD. METHODS: This study included 10,605 adult participants from the Third National Health and Nutrition Examination Survey. The MASLD diagnosis was based on ultrasound findings in patients without excessive alcohol intake or other liver diseases. MetS severity Z-scores were calculated and stratified into four categories low (1st-50th), moderate (>50th-75th), high (>75th-90th), and very high (>90th+)]. Multivariable adjusted logistic regression models with complex survey methods were used to test the effect of MetS severity on MASLD. RESULTS: The age-adjusted MASLD prevalence was 17.4%, 25.7%, 42.5, and 54.9% in adults with mild, moderate, high, and very high MetS severities, respectively (P-trend <0.001). MetS severity was significantly higher in patients with MASLD than in those without [mean percentile 60th vs. 44th, P<0.001]. Among patients with MASLD, Mexican-American and Black non-Hispanic females had significantly higher age-adjusted MetS severity (68th and 61st, respectively) than White non-Hispanic females 54th, while Black non-Hispanic males had significantly lower MetS severity (56th) than White non-Hispanic males (70th) (P-Interaction = 0.02). Adults with high and very high MetS severity had 2.27 (95% CI:1.70 to 3.03) and 3.12 (95% CI:2.20 to 4.42), respectively, higher adjusted odds of MASLD than those with mild MetS severity. CONCLUSIONS: Racial/ethnic disparities in MetS severity play a pivotal role in the risk of MASLD. Our findings highlight the potential clinical utility of the MetS severity score in identifying at-risk individuals, which will help guide targeted prevention and tailoring management strategies to mitigate the MASLD burden.

Impacts of glucagon-like peptide-1 receptor agonists on the risk of adverse liver outcomes in patients with metabolic dysfunction-associated steatotic liver disease cirrhosis and type 2 diabetes.

BACKGROUND/AIMS: We examined the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) initiation on long-term Adverse Liver Outcomes (ALO) in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) cirrhosis and type 2 diabetes using real-world data from the MarketScan database. METHODS: We conducted a retrospective cohort study of patients with MASLD cirrhosis and type 2 diabetes between 2012 and 2020. Cox proportional hazard models examine the association between GLP-1RAs initiation, modelled as time-dependent, and the risk of ALO, a composite endpoint defined by the first occurrence of hepatic decompensation(s), portal hypertension, hepatocellular carcinoma (HCC) or liver transplantation (LT). We used Overlap Propensity Score Weighting (OPSW) to account for confounding. The study included 459 GLP-1RAs and 4837 non-GLP-1RAs patients. RESULTS: The non-GLP-1RAs patients presented with 1411 (29%) ALO over 7431.7 person years, while GLP-1RAs patients had 32 (7%) ALO over 586.6 person years - risk rate difference 13.5 (95% CI: 11.4-15.7) per 100 person-years. The OPSW-adjusted risk of ALO was reduced by 36% (hazard ratio [HR]: 0.64; 95% CI: 0.54-0.76) in patients with vs. without GLP-1RAs initiation. GLP-1RAs initiation was associated with significant reductions in the adjusted risk of hepatic decompensation (HR: 0.74; 95% CI: 0.61-0.88), portal hypertension (HR: 0.73; 95% CI: 0.60-0.88), HCC (HR: 0.37; 95% CI: 0.20-0.63) and LT (HR: 0.24; 95% CI: 0.12-0.43). CONCLUSION: The use of GLP-1RAs was associated with significant risk reductions in long-term adverse liver outcomes, including hepatic decompensation, portal hypertension, HCC and LT, in MASLD cirrhosis patients with type 2 diabetes.

Comparative effectiveness of two interventions to increase colorectal cancer screening among females living in the rural Midwest.

PURPOSE: To assess the comparative effectiveness of a tailored, interactive digital video disc (DVD) intervention versus DVD plus patient navigation (PN) intervention versus usual care (UC) on the uptake of colorectal cancer (CRC) screening among females living in Midwest rural areas. METHODS: As part of a larger study, 663 females (ages 50-74) living in rural Indiana and Ohio and not up-to-date (UTD) with CRC screening at baseline were randomized to one of three study groups. Demographics , health status/history, and beliefs and attitudes about CRC screening were measured at baseline. CRC screening was assessed at baseline and 12 months from medical records and self-report. Multivariable logistic regression was used to determine whether females in each group were UTD for screening and which test they completed. RESULTS: Adjusted for covariates, females in the DVD plus PN group were 3.5× more likely to complete CRC screening than those in the UC group (odds ratio [OR] 3.62; 95% confidence interval [CI]: 2.09, 6.47) and baseline intention to receive CRC screening (OR 3.45, CI: 2.21,5.42) at baseline. Adjusting for covariates, there was no difference by study arm whether females who became UTD for CRC screening chose to complete a colonoscopy or fecal occult blood test/fecal immunochemical test. CONCLUSIONS: Many females living in the rural Midwest are not UTD for CRC screening. A tailored intervention that included an educational DVD and PN improved knowledge, addressed screening barriers, provided information about screening test options, and provided support was more effective than UC and DVD-only to increase adherence to recommended CRC screening.

Risk-management decision-making data from a community-based sample of racially diverse women at high risk of breast cancer: rationale, methods, and sample characteristics of the Daughter Sister Mother Project survey.

BACKGROUND: To understand the dynamics that limit use of risk-management options by women at high risk of breast cancer, there is a critical need for research that focuses on patient perspectives. Prior research has left important gaps: exclusion of high-risk women not in risk-related clinical care, exclusion of non-white populations, and lack of attention to the decision-making processes that underlie risk-management choices. Our objective was to create a more inclusive dataset to facilitate research to address disparities related to decision making for breast cancer risk management. METHODS: The Daughter Sister Mother Project survey collects comprehensive information about the experiences of women at high risk of breast cancer. We collected novel measures of feelings about and reactions to cancer screenings; knowledge, barriers, and facilitators of risk-management options; beliefs related to cancer risk and risk management; and involvement with loved ones who had cancer. Eligible individuals were non-Hispanic white and non-Hispanic Black adult women who self-identified as having high risk of breast cancer and had no personal history of cancer. Between October 2018 and August 2019, 1053 respondents completed the online survey. Of these, 717 were confirmed through risk prediction modeling to have a lifetime breast cancer risk of ≥ 20%. Sociodemographic characteristics of this sample were compared to those of nationally representative samples of the US population: the 2019 Health Information National Trends Survey and the Pew Research Center report: Jewish Americans in 2020. RESULTS: The sample of 717 women at objectively high risk of breast cancer was largely (95%) recruited from non-clinical sources. Of these respondents, only 31% had seen a genetic counselor, 34% had had genetic testing specific to breast cancer risk, and 35% had seen at least one breast or cancer care specialist. The sample includes 35% Black respondents and 8% with Ashkenazi Jewish ancestry. Although encompassing a substantial range of ages, incomes, and education levels, respondents are overall somewhat younger, higher-income, and more educated than the US population as a whole. CONCLUSIONS: The DSM dataset offers comprehensive data from a community-based, diverse sample of women at high risk of breast cancer. The dataset includes substantial proportions of Black and Ashkenazi Jewish women and women who are not already in clinical care related to their breast cancer risk. This sample will facilitate future studies of risk-management behaviors among women who are and are not receiving high-risk care, and of variations in risk-management experiences across race and ethnicity.