Advancing Translation of Clinical Research Into Practice and Population Health Impact Through Implementation Science.

Translational and implementation sciences aim to prioritize and guide efforts to create greater efficiency and speed of scientific innovation across the translational science continuum to improve patient and population health. Key principles and practices rooted in translational and implementation science may be incorporated into clinical trials research, particularly pragmatic trials, to improve the relevance and impact of scientific innovation. This thematic review intends to raise awareness on the value of translational and implementation science in clinical research and to encourage its use in designing and implementing clinical trials across the translational research continuum. Herein, we describe the gap in translating research findings into clinical practice, introduce translational and implementation science, and describe the principles and practices from implementation science that can be used in clinical trial research across the translational continuum to inform clinical practice, to improve population health impact, and to address health care inequities.

Trends in colorectal cancer screening from the National Health Interview Survey (NHIS): analysis of the impact of different modalities on overall screening rates.

Colorectal cancer (CRC) is the second leading cause of cancer-related mortality in adults in the United States. Despite compelling evidence of improved outcomes in CRC, screening rates are not optimal. This study aimed to characterize CRC screening trends over the last two decades and assess the impact of various screening modalities on overall CRC screening rates. Using National Health Interview Survey data from 2005-2021, we examined CRC screening (colonoscopy, mt-sDNA, FOBT/FIT, sigmoidoscopy, CT Colonography) rates among adults aged 50-75 years (n = 85,571). A pseudo-time-series cross-sectional (pseudo-TSCS) analysis was conducted including a random effects GLS regression model to estimate the relative impact of each modality on changes in CRC screening rates. Among 50-75-year-olds, the estimated CRC screening rate increased from 47.7% in 2005 to 69.9% in 2021, with the largest increase between 2005 and 2010 (47.7% to 60.7%). Rates subsequently plateaued until 2015 but increased from 63.5% in 2015 to 69.9% in 2018. This was primarily driven by the increased use of mt-sDNA (2.5% in 2018 to 6.6% in 2021). Pseudo-TSCS analysis results showed that mt-sDNA contributed substantially to the increase in overall screening rates (77.3%; p < 0.0001) between 2018-2021. While CRC screening rates increased from 2005 to 2021, they remain below the 80% goal. The introduction of mt-sDNA, a non-invasive screening test may have improved overall rates. Sustained efforts are required to further increase screening rates to improve patient outcomes and offering a range of screening options is likely to contribute to achieving this goal.

Disparities in Influenza, Pneumococcal, COVID-19 Vaccine Coverage in High-Risk Adults 19 to 64 Years of Age in Southeastern Minnesota, 2010-2021.

BACKGROUND: Despite effective vaccines against influenza, pneumococcus, and COVID-19, uptake has been suboptimal. RESEARCH QUESTION: Although disparities in vaccination by race and ethnicity have been observed, what is the role of other sociodemographic in US vaccine uptake? STUDY DESIGN AND METHODS: We conducted a population-based study using the Rochester Epidemiology Project (REP), a comprehensive medical records linkage system, to assess effects of sociodemographic factors including race, ethnicity, individual-level socioeconomic status (SES) via the housing-based socioeconomic status index, education, population density (urban or nonurban), and marital status with uptake of influenza, pneumococcal, and COVID-19 vaccination in high-risk adults. Adults at high risk of invasive pneumococcal disease residing in four counties in southeastern Minnesota who were 19 to 64 years of age were identified. Vaccination data were obtained from the Minnesota Immunization Information Connection and REP from January 1, 2010, through December 31, 2021. RESULTS: We identified 45,755 residents. Most were White (82%), non-Hispanic (94%), married (56%), and living in an urban setting (81%), with three-quarters obtaining at least some college education (74%). Although 45.1% were up-to-date on pneumococcal vaccines, 60.1% had completed the primary COVID-19 series. For influenza and COVID-19, higher SES, living in an urban setting, older age, and higher education positively correlated with vaccination. Magnitude of differences in race, education, and SES widened with booster vaccines. INTERPRETATION: This high-risk population is undervaccinated against preventable respiratory diseases, especially influenza and pneumococcus. Although national data reported improvement of disparities in COVID-19 vaccination uptake observed early in the pandemic, our data demonstrated gaps related to race, education level, SES, and age that widened with booster vaccines. Communities with high social vulnerabilities often show increased risk of severe disease outcomes, yet demonstrate lower uptake of preventive services. This highlights the need to understand better vaccine compliance and access in rural, lower SES, less-educated, Black, Hispanic, and younger populations, each of which were associated independently with decreased vaccination.

Provider communication contributes to colorectal cancer screening intention through improving screening outcome expectancies and perceived behavioral control.

Colorectal cancer (CRC) screening continues to be underutilized in the US despite the availability of multiple effective, guideline-recommended screening options. Provider recommendation has been consistently shown to improve screening completion. Yet, available literature provides little information as to how specific information providers communicate influence patient decision-making about CRC screening. We tested the pathways through which information communicated by providers about the "Why" and "How" of CRC screening using the mt-sDNA test contributes to intention to complete the test. Data came from a behavioral theory-informed survey that we developed to identify psychosocial factors associated with mt-sDNA screening. RTI International administered the survey between 03/2022-06/2022 to a sample of US adults ages 45-75 who received a valid order for mt-sDNA screening with a shipping date between 5/2021-9/2021. Participants completed an electronic or paper survey. We tested the proposed relationships using structural equation modeling and tested indirect effects using Monte Carlo method. A total of 2,973 participants completed the survey (response rate: 21.7%) and 81.6% (n = 2,427) reported have had a conversation with their health care provider about mt-sDNA screening before the test was ordered. We found that "Why" information from providers was positively associated with perceived effectiveness of mt-sDNA screening, while "How" information was positively associated with perceived ease of use. "Why" information contributed to screening intention through perceived effectiveness while "How" information contributed to screening intention through perceived ease of use. These findings emphasize the critical role of provider communication in shaping patient decision-making regarding CRC screening. CRC screening interventions could consider implementing provider-patient communication strategies focusing on improving patient understanding of the rationale for CRC screening and the effectiveness of available screening options as well as addressing barriers and enhancing patients' self-efficacy in completing their preferred screening option.

Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial.

Importance: Despite availability of a safe and effective vaccine, an estimated 36 500 new cancers in the US result from human papillomavirus (HPV) annually. HPV vaccine uptake falls short of national public health goals and lags other adolescent vaccines. Objective: To evaluate the individual and combined impact of 2 evidence-based interventions on HPV vaccination rates among 11- and 12-year-old children. Design, Setting, and Participants: The study team conducted a cluster randomized clinical trial with a stepped-wedge factorial design at 6 primary care practices affiliated with Mayo Clinic in southeastern Minnesota. Using block randomization to ensure balance of patient volumes across interventions, each practice was allocated to a sequence of four 12-month steps with the initial baseline step followed by 2 intermediate steps (none, 1, or both interventions) and a final step wherein all practices implemented both interventions. Each month, all eligible children who turned 11 or 12 years in the 2 months prior were identified and followed until the end of the step. Data were analyzed from April 2018 through March 2019. Participants included children who turned 11 or 12 years old and were due for a dose of the HPV vaccine. Interventions: Parents of eligible patients were mailed reminder/recalls following their child's birthdays. Health care professionals received confidential audit/feedback on their personal in-office success with HPV vaccine uptake via intra-campus mail. These 2 interventions were assessed separately and in combination. Main Outcomes and Measures: Eligible patients' receipt of any valid dose of HPV vaccine during the study step. Results: The cohort was comprised of 9242 11-year-olds (5165 [55.9%]) and 12-year-olds (4077 [44.1%]), and slightly more males (4848 [52.5%]). Parent reminder/recall resulted in 34.6% receiving a dose of HPV vaccine, health care professional audit/feedback, 30.4%, both interventions together resulted in 39.7%-all contrasted to usual care, 21.9%. Compared with usual care, the odds of HPV vaccination were higher for parent reminder/recall (odds ratio [OR], 1.56; 95% CI, 1.23-1.97) and for the combination of parent reminder/recall and health care professional audit/feedback (OR, 2.03; 95% CI, 1.44-2.85). Health care professional audit/feedback alone did not differ significantly from usual care (OR, 1.19; 95% CI, 0.94-1.51). Conclusions and Relevance: In this cluster randomized trial, the combination of parent reminder/recall and health care professional audit/feedback increased the odds of HPV vaccination compared with usual care. These findings underscore the value of simultaneous implementation of evidence-based strategies to improve HPV vaccination.

Attitudes and Experiential Factors Associated with Completion of mt-sDNA Test Kit for Colorectal Cancer Screening.

Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States. Despite the availability of multiple screening options, CRC screening is underutilized. We conducted a survey of patients (n = 2973) who were prescribed the multi-target stool DNA (mt-sDNA) screening test (commercialized as Cologuard® and manufactured by Exact Sciences Corporation) to understand attitudes and experiences that influence test completion and likelihood of future test completion. Using exploratory factor analyses, we developed three scales: Perceived Effectiveness, Perceived Ease of Use, and Perceived Comfort.

Cancer incidence in the Somali population of Olmsted County: A Rochester epidemiology project study.

BACKGROUND: Somali immigrants and refugees constitute one of the largest African ethnic groups immigrating to the United States over the past three decades with the majority resettling in the state of Minnesota. Previous studies have documented significant cancer screening disparities between the Somali population and the general population. However, little is known about cancer incidence among Somali groups living in the United States. METHODS: We determined the incidence of 18 types or sites of malignancy using ICD-9 and ICD-10 codes and compared them between Somali and non-Somali populations in Olmsted County, Minnesota utilizing the Rochester Epidemiology Project medical records-linkage infrastructure for the years 2000-2020. Poisson regression models were used to model the rates for each malignancy. RESULTS: There was a higher incidence and relative risk of liver malignancies among the Somali population versus non-Somali population, but lower relative risk and incidence of the following malignancies: breast, cervical, and melanoma. After direct age-sex adjustment to the United States 2000 Census population, liver was the most common cancer in Somali men, while breast cancer was the most common malignancy in women. CONCLUSION: Malignancies related to infectious agents such as viral hepatitis have a higher incidence in the Somali immigrant population of Olmsted County. There is a lower incidence of malignancies related to lifestyle factors in this Somali population. Findings of this study may help inform cancer prevention and screening strategies among Somali communities in the United States.

Barriers and facilitators of colorectal cancer screening using the 5As framework: A systematic review of US studies.

Despite clear evidence that regular screening reduces colorectal cancer (CRC) mortality and the availability of multiple effective screening options, CRC screening continues to be underutilized in the US. A systematic literature search of four databases - Ovid, Medline, EBSCHOhost, and Web of Science - was conducted to identify US studies published after 2017 that reported on barriers and facilitators to CRC screening adherence. Articles were extracted to categorize relevant CRC screening barriers or facilitators that were assessed against CRC screening outcomes using the 5As dimensions: Access, Affordability, Acceptance, Awareness, Activation. Sixty-one studies were included. Fifty determinants of screening within the 5As framework and two additional dimensions including Sociodemographics and Health Status were identified. The Sociodemographics, Access, and Affordability dimensions had the greatest number of studies included. The most common factor in the Access dimension was contact with healthcare systems, within the Affordability dimension was insurance, within the Awareness dimension was knowledge CRC screening, within the Acceptance dimension was health beliefs, within the Activation dimension was prompts and reminders, within the Sociodemographics dimension was race/ethnicity, and among the Health Status dimension was chronic disease history. Among all studies, contact with healthcare systems, insurance, race/ethnicity, age, and education were the most common factors identified. CRC screening barriers and facilitators were identified across individual, clinical, and sociocontextual levels. Interventions that consider multilevel strategies will most effectively increase CRC screening adherence.

Designing persuasive health education for patients seeking unproven stem cell interventions.

Misinformation among clinics advertising unproven stem cell interventions (SCIs) is pervasive and has resulted in patient and societal harms. Most bioethics commentaries have centered on advancing regulatory approaches to curtail the supply side of the market, but insufficient attention has been paid to considering strategies influencing patient demand. In this article, we offer an ethical justification for the design and deployment of persuasive patient education on unproven SCIs and distinguish it from didactic and manipulative education frames. Persuasive education should aim to correct and inoculate against misinformation about unproven SCIs and instill a sense of caution among patients considering experimental interventions outside of a clinical trial. We outline various communication strategies to effectively correct or inoculate against SCI misinformation. The stem cell community needs to invest in understanding patients' informational sources, attitudes, and beliefs about SCIs to develop and implement evidence-based persuasive education to promote informed decision-making about these therapies.

Stool-Based Colorectal Cancer Screening Test Performance Characteristics in Those With and Without Hemorrhoids.

Objective: To evaluate the effect of hemorrhoids on noninvasive stool test performance for colorectal cancer (CRC) screening. Patients and Methods: We conducted a retrospective cohort study of test characteristics for the fecal immunochemical test (FIT) and the multitarget stool DNA (mt-sDNA) test, on the basis of hemorrhoid status, recorded at the time of colonoscopy, among patients enrolled in the pivotal prospective study for mt-sDNA that was conducted from June 2011, to May 2013. Test characteristics (sensitivity, specificity, positive, and negative predictive values) for FIT and mt-sDNA (performed < 90 days before colonoscopy) were stratified by the presence of hemorrhoids and compared. Results: Hemorrhoids were found in 51.7% (5163 of 9989) of the study cohort. Across all test characteristics, there were no statistically significant differences for FIT or mt-sDNA when stratified by hemorrhoid status. Analysis revealed mt-sDNA sensitivity of 44% and 41% for advanced precancerous lesions in nonhemorrhoidal and hemorrhoid patients, respectively (P=.41). The FIT sensitivity among the same lesion category was 24.9% in patients without hemorrhoids and 22.8% in those with hemorrhoids (P=.48). The mt-sDNA specificity was 86.4% in patients without hemorrhoids vs 87.7% in those with hemorrhoids (P=.67), although FIT specificity was 95.0% among patients without hemorrhoids vs 94.7% in those with hemorrhoids (P=.44). Conclusion: The presence of asymptomatic hemorrhoids did not adversely affect test performance in this large clinical study. These findings suggest that in the absence of overt gastrointestinal bleeding, FIT and mt-sDNA are options for CRC screening, irrespective of hemorrhoid status. Trial Registration: clinicaltrials.gov Identifier: NCT01397747.

Parent-reported Barriers and Parental Beliefs Associated with Intentions to Obtain HPV Vaccination for Children in a Primary care Patient Population in Minnesota, USA.

Human papillomavirus (HPV) vaccine uptake among adolescents remains suboptimal in the US. The COVID-19 pandemic posed new challenges to increase HPV vaccination rates. To characterize parent-reported barriers to obtain HPV vaccination for their children and to identify psychosocial factors associated with parents' intention to vaccinate their children for HPV, we administered parent surveys between April 2020 and January 2022 during a randomized pragmatic trial assessing the impact of evidence-based implementation strategies on HPV vaccination rates for adolescent patients at six Mayo Clinic primary care practices in Southeast Minnesota. A total of 342 surveys were completed (response rate 34.1%). Analyses were focused on parents of unvaccinated children (n = 133). The survey assessed the main reason the child did not receive the HPV vaccine, parental beliefs about the vaccine, and the parent's intention to vaccinate the child for HPV in the next 12 months. Frequently reported awareness and access barriers to HPV vaccination included not knowing the child was due (17.8%) and COVID-19 related delay (11.6%). Frequently reported attitudinal barriers include the belief that the child was too young for the vaccine (17.8%) and that the vaccine is not proven to be safe (16.3%). Injunctive social norm (Adjusted-OR = 3.15, 95%CI: 1.94, 5.41) and perceived harm beliefs (Adjusted-OR = 0.58, 95%CI: 0.35, 0.94) about the HPV vaccine were positively and negatively associated with HPV vaccination intention, respectively. Our findings suggest that continued efforts to overcome parental awareness, access, and attitudinal barriers to HPV vaccination are needed and underscore the importance of utilizing evidence-based health system-level interventions.

Breast Cancer Mode of Detection in a Population-Based Cohort.

OBJECTIVE: To evaluate how breast cancers come to clinical attention (mode of detection [MOD]) in a population-based cohort, determine the relative frequency of different MODs, and characterize patient and tumor characteristics associated with MOD. PATIENTS AND METHODS: We used the Rochester Epidemiology Project to identify women ages 40 to 75 years with a first-time diagnosis of breast cancer from May 9, 2017, to May 9, 2019 (n=500) in a 9-county region in Minnesota. We conducted a retrospective medical record review to ascertain the relative frequency of MODs, evaluating differences between screening mammography vs all other MODs by breast density and cancer characteristics. Multiple logistic regression was conducted to examine the likelihood of MOD for breast density and stage of disease. RESULTS: In our population-based cohort, 162 of 500 breast cancers (32.4%) were detected by MODs other than screening mammography, including 124 (24.8%) self-detected cancers. Compared with women with mammography-detected cancers, those with MODs other than screening mammography were more frequently younger than 50 years of age (P=.004) and had higher-grade tumors (P=.007), higher number of positive lymph nodes (P<.001), and larger tumor size (P<.001). Relative to women with mammography-detected cancers, those with MODs other than screening mammography were more likely to have dense breasts (odds ratio, 1.87; 95% CI, 1.20 to 2.92; P=.006) and advanced cancer at diagnosis (odds ratio, 3.58; 95% CI, 2.29 to 5.58; P<.001). CONCLUSION: One-third of all breast cancers in this population were detected by MODs other than screening mammography. Increased likelihood of nonmammographic MODs was observed among women with dense breasts and advanced cancer.

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of EHR-facilitated collaborative symptom control in cancer (E2C2): addendum.

We previously described the hypotheses, outcomes, design, and analysis for E2C2, a pragmatic stepped-wedge trial to assess an intervention to improve symptom control in patients with cancer. Subsequent consideration of the design and cohort led to the addition of a second primary hypothesis. This article describes and presents the rationale for this second hypothesis. This addendum also details a revised analytic approach, necessitated by inconsistencies in the original analytic plan. The design, outcomes, and other aspects of the protocol remain unchanged.

Disparities in vaccination rates in solid organ transplant patients.

INTRODUCTION: Vaccinations against preventable respiratory infections such as Streptococcus pneumoniae and influenza are important in immunosuppressed solid organ transplant (SOT) recipients. Little is known about the role of age, race, ethnicity, sex, and sociodemographic factors including rurality, or socioeconomic status (SES) associated with vaccine uptake in this population. METHODS: We conducted a population-based study using the Rochester Epidemiology Project, a medical records linkage system, to assess socioeconomic and demographic factors associated with influenza and pneumococcal vaccination rates among adult recipients of solid organ transplantation (aged 19-64 years) living in four counties in southeastern Minnesota. Vaccination data were obtained from the Minnesota Immunization Information Connection from June 1, 2010 to June 30, 2020. Vaccination rate was assessed with Poisson and logistic regression models. RESULTS: A total of 468 SOT recipients were identified with an overall vaccination rate of 57%-63% for influenza and 56% for pneumococcal vaccines. As expected, vaccination for pneumococcal vaccine positively correlated with influenza vaccination. Rural patients had decreased vaccination in both compared to urban patients, even after adjusting for age, sex, race, ethnicity, and SES. Although the population was mostly White and non-Hispanic, neither vaccination differed by race or ethnicity, but influenza vaccination did by SES. Among organ transplant groups, liver and lung recipients were least vaccinated for influenza, and heart recipients were least up-to-date on pneumococcal vaccines. CONCLUSIONS: Rates of vaccination were below national goals. Rurality was associated with undervaccination. Further investigation is needed to understand and address barriers to vaccination among transplant recipients.

Factors influencing colorectal cancer screening decision-making among average-risk US adults.

Colorectal cancer (CRC) screening rates remain suboptimal in the US. We examined patient-focused concerns and influence of various factors (e.g., test attributes, provider recommendation) on CRC screening decision-making. We conducted a web survey with 1595 US adults aged 40-75 from a nationally representative panel in November 2019 (completion rate: 31.3 %). Analyses focused on individuals aged 45-75 years at average-risk for CRC (n = 1062). All participants rated their level of concern about various CRC screening test/procedure attributes. Participants who have screened previously designated the three most important attributes for choosing a screening method and rated how various factors influenced their decision to use a particular method. The top concern for participants who have not screened previously was having an invasive procedure (54.2 %) while the top concerns for participants who have screened previously were completing a colon prep (41.3 %) and test/procedure accuracy (41 %). Cost/insurance coverage was most frequently ranked among the most important attributes (48.5 %), followed by where the test can be taken (45.7 %) and test accuracy (43.6 %). Provider recommendation was reported as the major motivator across screening methods. Other factors that were frequently reported as very influential included convenience and comfort for the stool-based methods and scientific/clinical evidence and insurance coverage for colonoscopy. Variations by age, sex, and race/ethnicity were noted. Findings demonstrate that along with provider recommendation, patient preferences regarding test/procedure attributes and preparation requirements are influential in screening decision-making, highlighting the need for clinicians to involve patients in shared decision-making and incorporate patient needs and preferences in establishing screening strategies.

Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening in a medicaid population.

Colorectal cancer (CRC) is the third leading cause of cancer death in the US. Early detection improves CRC outcomes and multiple options are endorsed for CRC screening; however, adherence remains challenging. Among Medicaid enrollees, the fecal immunochemical test (FIT) is often used for average-risk CRC screening, with suboptimal adherence rates reported (12.3-23.2 %). The navigation-supported (personalized outreach by phone, mail, email and text), at home collection, multi-target stool DNA (mt-sDNA) test represents a relatively recent and broadly accessible option for average-risk CRC screening in Medicaid enrollees. We assessed cross-sectional mt-sDNA adherence in a national sample of Medicaid patients. Data from Exact Sciences Laboratories LLC (ESL; Madison, WI) were retrospectively analyzed. Participants included individuals 45 + years covered by Fee-For-Service (FFS)- or Managed-Medicaid. Primary analysis focused on the 50-74 age cohort and included those with valid mt-sDNA orders between January 1-December 31, 2018. Data from 25,794 individuals who received valid orders for mt-sDNA were included in analysis (61.2 % women; mean age at order 57.5 years). Overall adherence - completion of an ordered test - was 51.3 %. Adherence was 54.6 % in Managed-Medicaid and 38.9 % in FFS-Medicaid. Adherence by age was: 51.5 % for 50-64 years and 47.7 % for 65-74 years. Mt-sDNA tests ordered by gastroenterologists had higher adherence (60.5 %) compared with primary care clinicians (51.3 %). These data from a large, national sample of Medicaid-insured patients substantiate mt-sDNA testing as a viable patient-supported, home-based option to improve average-risk CRC screening participation in Medicaid enrollees.

Development of a colorectal cancer screening intervention for Alaska Native people during a pandemic year.

Objectives: Alaska Native (AN) people experience twice the rate of colorectal cancer (CRC) as US Whites. There is a need for increased screening and early detection. We describe the development and implementation of a randomized controlled trial of the multi-target stool DNA test (mt-sDNA; Cologuard® Exact Sciences, Madison WI) to increase CRC screening among AN people. Methods: A total of 32 rural/remote AN communities were randomized to a varied intensity intervention (patient navigation vs mailed health education) compared to 14 communities receiving usual opportunistic care. Outcome measures include screening completion and method used (mt-sDNA vs colonoscopy). Health care provider interviews and AN patient focus groups will be used to assess patient-, provider-, and system-level CRC screening promoters and barriers. Results: The study began in April 2020 during the COVID-19 pandemic, resulting in a number of challenges and study adaptations. These included difficulty finding laboratory space, lack of timely mail service due to flight reductions across the state, and travel restrictions that led to postponement of in-person focus groups. Videoconferencing platforms for Tribal engagement replaced face-to-face interactions. After an extensive search, a laboratory with space available was identified and the preprocessing laboratory established. Study staff will work closely with patients to monitor mail service to get mt-sDNA kits sent on time. We are also exploring the use of videoconferencing platforms as alternatives to in-person focus groups. Conclusions: Despite the challenges encountered during the COVID-19 pandemic, we successfully initiated the intervention and established the first mt-sDNA preprocessing laboratory in Alaska.

Rates of Asymptomatic COVID-19 Infection and Associated Factors in Olmsted County, Minnesota, in the Prevaccination Era.

Objective: To estimate rates and identify factors associated with asymptomatic COVID-19 in the population of Olmsted County during the prevaccination era. Patients and Methods: We screened first responders (n=191) and Olmsted County employees (n=564) for antibodies to SARS-CoV-2 from November 1, 2020 to February 28, 2021 to estimate seroprevalence and asymptomatic infection. Second, we retrieved all polymerase chain reaction (PCR)-confirmed COVID-19 diagnoses in Olmsted County from March 2020 through January 2021, abstracted symptom information, estimated rates of asymptomatic infection and examined related factors. Results: Twenty (10.5%; 95% CI, 6.9%-15.6%) first responders and 38 (6.7%; 95% CI, 5.0%-9.1%) county employees had positive antibodies; an additional 5 (2.6%) and 10 (1.8%) had prior positive PCR tests per self-report or medical record, but no antibodies detected. Of persons with symptom information, 4 of 20 (20%; 95% CI, 3.0%-37.0%) first responders and 10 of 39 (26%; 95% CI, 12.6%-40.0%) county employees were asymptomatic. Of 6020 positive PCR tests in Olmsted County with symptom information between March 1, 2020, and January 31, 2021, 6% (n=385; 95% CI, 5.8%-7.1%) were asymptomatic. Factors associated with asymptomatic disease included age (0-18 years [odds ratio {OR}, 2.3; 95% CI, 1.7-3.1] and >65 years [OR, 1.40; 95% CI, 1.0-2.0] compared with ages 19-44 years), body mass index (overweight [OR, 0.58; 95% CI, 0.44-0.77] or obese [OR, 0.48; 95% CI, 0.57-0.62] compared with normal or underweight) and tests after November 20, 2020 ([OR, 1.35; 95% CI, 1.13-1.71] compared with prior dates). Conclusion: Asymptomatic rates in Olmsted County before COVID-19 vaccine rollout ranged from 6% to 25%, and younger age, normal weight, and later tests dates were associated with asymptomatic infection.

The COMPASS study: A prospective, randomized, multi-center trial testing the impact of a clinic-based intervention informing patients of colorectal cancer screening options on screening completion.

BACKGROUND: Colorectal cancer (CRC) screening is underutilized despite evidence that screening improves survival. Since healthcare provider recommendation is a strong predictor of CRC screening completion, providers are encouraged to engage eligible patients in collaborative decision-making that attends to patients' values, needs, and preferences for guideline-concordant screening modalities. METHODS: This three-arm randomized controlled trial is testing the effectiveness of an evidence-based video intervention informing patients of screening choices delivered in a clinic prior to a healthcare appointment. We hypothesize that participants randomized to watch a basic video describing CRC and screening in addition to an informed choice video showing the advantages and disadvantages of fecal immunochemical test (FIT), stool DNA FIT (s-DNA FIT), and colonoscopy (Arm 3) will exhibit a greater proportion of time adherent to CRC screening guidelines after 1, 3 and 6 years than those who only watch the basic video (Arm 2) or no video at all (Arm 1). Primary care and Obstetrician/Gynecology clinics across the United States are recruiting 5280 patients, half who have never been screened and half who previously screened but are currently not guideline adherent. Participants complete surveys prior to and following an index appointment to self-report personal, cognitive, and environmental factors potentially associated with screening. Proportion of time adherent to screening guidelines will be assessed using medical record data and supplemented with annual surveys self-reporting screening. CONCLUSION: Results will provide evidence on the effectiveness of informational and motivational videos to encourage CRC screening that can be easily integrated into clinical practice. CLINICALTRIALS: gov #NCT05246839.

Multi-morbidity and patient-reported functional limitations: a population-based cohort study.

Background: Persons who accumulate chronic conditions at a rate faster than their peers may experience accelerated aging and poor health outcomes, including functional limitations. Methods: Adults aged ≥40 years who resided in Olmsted County, Minnesota on 1 January 2006 were identified. The prevalence of 21 chronic conditions was ascertained, and age-specific quartiles of the number of chronic conditions was estimated within 4 age groups: 40-54, 55-64, 65-74, and ≥75 years. Difficulty with nine patient-reported functional limitations (including basic and instrumental activities of daily living and mobility activities) were ascertained through 31 October 2018. Cox regression was used to model associations of chronic condition quartiles with new-onset functional limitations considered separately. We estimated absolute risk differences and hazard ratios stratified by age group, and adjusted for sex, race, ethnicity, marital status, education, and the residual effect of age. Results: Among 39,624 persons (44.5% men, 93.2% white), the most common reported new functional limitations were difficulty with climbing stairs, walking, and housekeeping. For all functional limitations, the absolute risk differences were largest among the oldest age group (≥75 years). Approximately twofold increased hazard ratios were observed among those in the highest vs. lowest quartile for the three oldest age groups, and approximately threefold or higher hazard ratios were observed for persons aged 40-54 years. Conclusion: Persons with increased accumulation of chronic conditions experience increased risks of developing functional limitations compared to their peers. These findings underscore the importance of assessing health status and of employing interventions to prevent and effectively manage multi-morbidity at all ages.