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COVID-19 vaccine hesitancy and uptake among Southern states in the US has been problematic throughout the pandemic. To characterize COVID-19 vaccine hesitancy and uptake among medically underserved communities in Tennessee. We surveyed 1482 individuals targeting minority communities in Tennessee from 2 October 2021 to 22 June 2022. Participants who indicated that they did not plan to receive or were unsure whether to receive the COVID-19 vaccine were considered vaccine-hesitant. Among participants, 79% had been vaccinated, with roughly 5.4% not likely at all to be vaccinated in the next three months from the date that the survey was conducted. When focusing particularly on Black/AA people and white people, our survey results revealed a significant association between race (Black/AA, white, or people of mixed Black/white ancestry) and vaccination status (vaccinated or unvaccinated) (p-value = 0.013). Approximately 79.1% of all participants received at least one dose of a COVID-19 vaccine. Individuals who were concerned with personal/family/community safety and/or wanted a return to normalcy were less likely to be hesitant. The study found that the major reasons cited for refusing the COVID-19 vaccines were distrust in vaccine safety, concerns about side effects, fear of needles, and vaccine efficacy.

BackgroundPrior studies have documented differences in the age, racial, and ethnic characteristics among patients with SARS-CoV-2 infection. However, little is known about how these characteristics changed over time during the pandemic and whether racial, ethnic, and age disparities evident early in the pandemic were persistent over time. This study reports on trends in SARS-CoV-2 infections among U.S. adults from March 1, 2020 to January, 31 2022, using data from electronic health records.Methods and FindingsWe captured repeated cross-sectional information from 43 large healthcare systems in 52 U.S. States and territories, participating in PCORnet®, the National Patient-Centered Clinical Research Network. Using distributed queries executed at each participating institution, we acquired information for all patients ≥ 20 years of age who were tested for SARS-CoV-2 (both positive and negative results), including care setting, age, sex, race, and ethnicity by month as well as comorbidities (assessed with diagnostic codes).During this time period, 1,325,563 patients had positive (13% inpatient) and 6,705,868 patients had negative (25% inpatient) viral tests for SARS-CoV-2. Disparities in testing positive were present across racial and ethnic groups, especially in the inpatient setting. Compared to White patients, Black or African American and other race patients had relative risks for testing positive of 1.5 or greater in the inpatient setting for 12 of the 23-month study period. Compared to non-Hispanic patients, Hispanic patients had relative risks for testing positive in the inpatient setting of 1.5 or greater for 16 of 23. Ethnic and racial differences were present in emergency department and ambulatory settings but were less common across time than in inpatient settings. Trends in infections by age group demonstrated higher test positivity for older patients in the inpatient setting only for most months, except for June and July of 2020, April to August 2021, and January 2022. Comorbidities were common, with much higher rates among those hospitalized; hypertension (38% of patients SARS-CoV-2 positive vs. 29% for those negative) and type 2 diabetes mellitus (22% vs. 13%) were the most common.Conclusion and RelevanceRacial and ethnic disparities changed over time among persons infected with SARS-CoV-2. These trends highlight potential underlying mechanisms, such as poor access to care and differential vaccination rates, that may have contributed to greater disparities, especially early in the pandemic. Monitoring data on characteristics of patients testing positive in real time could allow public health officials and policymakers to tailor interventions to ensure that patients and communities most in need are receiving adequate testing, mitigation strategies, and treatment.

To examine whether depression status before metabolic and bariatric surgery (MBS) influenced 5-year weight loss, diabetes, and safety/utilization outcomes in the PCORnet Bariatric Study.Research on the impact of depression on MBS outcomes is inconsistent with few large, long-term studies.Data were extracted from 23 health systems on 36,871 patients who underwent sleeve gastrectomy (SG; n=16,158) or gastric bypass (RYGB; n=20,713) from 2005-2015. Patients with and without a depression diagnosis in the year prior to MBS were evaluated for % total weight loss (%TWL), diabetes outcomes, and postsurgical safety/utilization (reoperations, revisions, endoscopy, hospitalizations, mortality) at 1, 3 and 5 years after MBS.27.1% of SG and 33.0% of RYGB patients had preoperative depression, and they had more medical and psychiatric comorbidities than those without depression. At 5 years of follow-up, those with depression, versus those without depression, had slightly less %TWL after RYGB, but not after SG (between group difference = 0.42%TWL, p=0.04). However, patients with depression had slightly larger HbA1c improvements after RYGB but not after SG (between group difference = -0.19, p=0.04). Baseline depression did not moderate diabetes remission or relapse, reoperations, revision, or mortality across operations; however, baseline depression did moderate the risk of endoscopy and repeat hospitalization across RYGB versus SG.Patients with depression undergoing RYGB and SG had similar weight loss, diabetes, and safety/utilization outcomes to those without depression. The effects of depression were clinically small compared to the choice of operation.

ImportanceBariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups.ObjectiveTo compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.Design, Setting, and ParticipantsThis was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB or SG operation between January 1, 2005, and September 30, 2015, at participating health systems. Patient race and ethnicity included Black, Hispanic, White, other, and unrecorded. Data were analyzed from July 1, 2021, to January 17, 2022.ExposureRYGB or SG.OutcomesPercentage total weight loss (%TWL); type 2 diabetes remission, relapse, and change in hemoglobin A1c (HbA1c) level; and postsurgical safety and utilization outcomes (operations, interventions, revisions/conversions, endoscopy, hospitalizations, mortality, 30-day major adverse events) at 1, 3, and 5 years after surgery.ResultsA total of 36 871 patients (mean [SE] age, 45.0 [11.7] years; 29 746 female patients [81%]) were included in the weight analysis. Patients identified with the following race and ethnic categories: 6891 Black (19%), 8756 Hispanic (24%), 19 645 White (53%), 826 other (2%), and 783 unrecorded (2%). Weight loss and mean reductions in HbA1c level were larger for RYGB than SG in all years for Black, Hispanic, and White patients (difference in 5-year weight loss: Black, −7.6%; 95% CI, −8.0 to −7.1; P < .001; Hispanic, −6.2%; 95% CI, −6.6 to −5.9; P < .001; White, −5.9%; 95% CI, −6.3 to −5.7; P < .001; difference in change in year 5 HbA1c level: Black, −0.29; 95% CI, −0.51 to −0.08; P = .009; Hispanic, −0.45; 95% CI, −0.61 to −0.29; P < .001; and White, −0.25; 95% CI, −0.40 to −0.11; P = .001.) The magnitude of these differences was small among racial and ethnic groups (1%-3% of %TWL). Black and Hispanic patients had higher risk of hospitalization when they had RYGB compared with SG (hazard ratio [HR], 1.45; 95% CI, 1.17-1.79; P = .001 and 1.48; 95% CI, 1.22-1.79; P < .001, respectively). Hispanic patients had greater risk of all-cause mortality (HR, 2.41; 95% CI, 1.24-4.70; P = .01) and higher odds of a 30-day major adverse event (odds ratio, 1.92; 95% CI, 1.38-2.68; P < .001) for RYGB compared with SG. There was no interaction between race and ethnicity and operation type for diabetes remission and relapse.Conclusions and RelevanceVariability of the comparative effectiveness of operations for %TWL and HbA1c level across race and ethnicity was clinically small; however, differences in safety and utilization outcomes were clinically and statistically significant for Black and Hispanic patients who had RYGB compared with SG. These findings can inform shared decision-making regarding bariatric operation choice for different racial and ethnic groups of patients.

Introduction:Dissemination of results to research participants is largely missing from the practices of most researchers. Few resources exist that describe best practices for disseminating information to this important stakeholder group.Methods:Four focus groups were conducted with a diverse group of individuals. All participants were part of a Patient-Centered Outcomes Research Institute-funded survey study. Focus groups aimed to identify participants’ preferences about receiving research results and their reactions to three different dissemination platforms.Results:Four focus groups with 37 participants were conducted, including: (1) adults with one comorbidity, at least a college education, and high socioeconomic status (SES); (2) adults with one comorbidity, less than a college education, and lower SES; (3) adults with low health literacy and/or numeracy; and (4) Black or African American adults. Participants discussed their preferences for research results delivery and how each of the platforms met those preferences. This included information needs as they relate to content and scope, including a desire to receive both individual and aggregate results, and study summaries. Email, paper, and website were all popular avenues of presentation. Some desired a written summary, and others preferred videos or visual graphics. Importantly, participants emphasized the desire for having a choice in the timing, frequency, and types of results.Conclusion:Research participants prefer to receive research results, including study impact and key findings, disseminated to them in an engaging format that allows choice of when and how the information is presented. The results encourage new standards whereby research participants are considered a critical stakeholder group.

Amid increasing interest in improving the patient-centeredness of research, new forms of engagement are emerging that enable researchers to get input from community members on research goals, methods, and implementation. This input often includes stories, which are useful for understanding lived experiences of illness and encounters with health care organizations, and for locating these experiences within larger meta-narratives of specific communities. We analyzed the stories in transcripts of 13 Community Engagement Studios and identified 4 major functions that the stories served in the sessions. Major functions included: (1) establishing mutual understanding, (2) adding expansion and depth, (3) characterizing abstract concepts, and (4) providing context for experience, with the latter being the most frequent. We assert that stories can serve to better communicate the complex contexts of patient experiences, helping to align research priorities and research design with community interests, leading to more patient-centered innovations in clinical practice.

BackgroundNational data from diverse institutions across the United States are critical for guiding policymakers as well as clinical and public health leaders. This study characterized a large national cohort of patients diagnosed with COVID-19 in the U.S., compared to patients diagnosed with viral pneumonia and influenza.Methods and FindingsWe captured cross-sectional information from 36 large healthcare systems in 29 U.S. states, participating in PCORnet®, the National Patient-Centered Clinical Research Network. Patients included were those diagnosed with COVID-19, viral pneumonia and influenza in any care setting, starting from January 1, 2020. Using distributed queries executed at each participating institution, we acquired information for patients on care setting (any, ambulatory, inpatient or emergency department, mechanical ventilator), age, sex, race, state, comorbidities (assessed with diagnostic codes), and medications used for treatment of COVID-19 (hydroxychloroquine with or without azithromycin; corticosteroids, anti-interleukin-6 agents).During this time period, 24,516 patients were diagnosed with COVID-19, with 42% in an emergency department or inpatient hospital setting; 79,639 were diagnosed with viral pneumonia (53% inpatient/ED) and 163,984 with influenza (41% inpatient/ED). Among COVID-19 patients, 68% were 20 to Conclusion and RelevancePCORnet leverages existing data to capture information on one of the largest U.S. cohorts to date of patients diagnosed with COVID-19 compared to patients diagnosed with viral pneumonia and influenza.

Objective To describe PCORnet, a clinical research network developed for patient-centered outcomes research on a national scale. Study Design and Setting Descriptive study of the current state and future directions for PCORnet. We conducted cross-sectional analyses of the health systems and patient populations of the 9 Clinical Research Networks and 2 Health Plan Research Networks that are part of PCORnet. Results Within the Clinical Research Networks electronic health data are currently collected from 337 hospitals, 169,695 physicians, 3,564 primary care practices, 338 emergency departments, and 1,024 community clinics. Patients can be recruited for prospective studies from any of these clinical sites. The Clinical Research Networks have accumulated data from 80 million patients with at least 1 visit from 2009-2018. The PCORnet Health Plan Research Network population of individuals with a valid enrollment segment from 2009-2019 exceeds 60 million individuals, who on average have 2.63 years of follow-up. Conclusion PCORnet’s infrastructure comprises clinical data from a diverse cohort of patients and has the capacity to rapidly access these patient populations for pragmatic clinical trials, epidemiological research, and patient-centered research on rare diseases., Highlights • PCORnet is a national network-of-networks developed to conduct patient-centered outcomes research. • There are 9 Clinical Research Networks and 2 Health Plan Research Networks within PCORnet. • The Clinical Research Networks have collected EHR data for a cohort of 80 million individuals, and the Health Plan Network have collected enrollment and claims files on over 60 million individuals. • PCORnet infrastructure can support large-scale pragmatic clinical trials and observational research using its distributed data network.

In 2016, the Patient-Centered Outcomes Research Institute funded the National Patient Centered Clinical Research Network (PCORnet) Bariatric Study (PBS). Understanding the experience of postoperative patients was a key component of this study. Nine focus groups were conducted in Southern California, Louisiana, Pennsylvania, and Ohio and in a national advocacy conference for patients with obesity. Participants were identified and recruited in both clinical and community settings. Focus group transcripts were analyzed using an iterative inductive-deductive approach to identify global overarching themes. There were 76 focus group participants. Participants were mostly women (81.4%), had primarily undergone gastric sleeve (47.0%), were non-Hispanic white (51.4%), had some college education (44.3%), and made $100,000 annual income or less (65.7%). Qualitative findings included negative reactions patients received from friends, family, and co-workers once they disclosed that they had bariatric surgery to lose weight; and barriers to follow-up care included insurance coverage, emotional and situational challenges, and physical pain limiting mobility. These findings confirm the other qualitative findings in this area. The approach to bariatric surgery should be expanded to provide long-term comprehensive care that includes in-depth postoperative lifetime monitoring of emotional and physical health.

OBJECTIVES To ensure meaningful engagement of stakeholders (patients, clinicians, and communities) in developing the Mid-South Clinical Data Research Network (MS-CDRN), we implemented a comprehensive, multilevel approach: (1) identify barriers to involving stakeholders in governance, network design, and implementation; (2) engage stakeholders in priority setting and research topic generation; (3) develop strategies to fully integrate stakeholders in CDRN governance and oversight; and (4) solicit guidance on patient-centered tools and strategies for recruiting research participants. METHODS We engaged stakeholders: (1) as integral research team members; (2) on oversight and advisory committees; (3) as consultants (using Community Engagement Studios); and (4) through interviews and surveys. We recruited stakeholders from community health centers, churches, barbershops, health fairs, a volunteer registry, and a patient portal. We prioritized recruitment from populations often underrepresented in research. RESULTS During the first 18 months, we engaged 5670 stakeholders in developing the MS-CDRN. These were research team members and on governance committees (N=10), consultants (N=58), survey respondents (N=5543), and interviewees (N=59). Stakeholders identified important barriers and facilitators to engagement, developed stakeholder-informed policies, provided feedback on priority topics and research questions, and developed an intake process for data requests and interventional studies that included reviewing for appropriate patient-centeredness, patient engagement, and dissemination. DISCUSSION Multilevel stakeholder engagement is a novel systematic approach to developing a meaningful patient-centered and patient-engaged research program. This approach allows ongoing input from highly engaged stakeholders while leveraging focused input from larger, more diverse groups to enhance the patient-centeredness of research and increase relevance to broader audiences.

Background There has been a dramatic shift in use of bariatric procedures, but little is known about their long-term comparative effectiveness. Objective To compare weight loss and safety among bariatric procedures. Design Retrospective observational cohort study, January 2005 to September 2015. (ClinicalTrials.gov: NCT02741674). Setting 41 health systems in the National Patient-Centered Clinical Research Network. Participants 65 093 patients aged 20 to 79 years with body mass index (BMI) of 35 kg/m2 or greater who had bariatric procedures. Intervention 32 208 Roux-en-Y gastric bypass (RYGB), 29 693 sleeve gastrectomy (SG), and 3192 adjustable gastric banding (AGB) procedures. Measurements Estimated percent total weight loss (TWL) at 1, 3, and 5 years; 30-day rates of major adverse events. Results Total numbers of eligible patients with weight measures at 1, 3, and 5 years were 44 978 (84%), 20 783 (68%), and 7159 (69%), respectively. Thirty-day rates of major adverse events were 5.0% for RYGB, 2.6% for SG, and 2.9% for AGB. One-year mean TWLs were 31.2% (95% CI, 31.1% to 31.3%) for RYGB, 25.2% (CI, 25.1% to 25.4%) for SG, and 13.7% (CI, 13.3% to 14.0%) for AGB. At 1 year, RYGB patients lost 5.9 (CI, 5.8 to 6.1) percentage points more weight than SG patients and 17.7 (CI, 17.3 to 18.1) percentage points more than AGB patients, and SG patients lost 12.0 (CI, 11.6 to 12.5) percentage points more than AGB patients. Five-year mean TWLs were 25.5% (CI, 25.1% to 25.9%) for RYGB, 18.8% (CI, 18.0% to 19.6%) for SG, and 11.7% (CI, 10.2% to 13.1%) for AGB. Patients with diabetes, those with BMI less than 50 kg/m2, those aged 65 years or older, African American patients, and Hispanic patients lost less weight than patients without those characteristics. Limitation Potential unobserved confounding due to nonrandomized design; electronic health record databases had missing outcome data. Conclusion Adults lost more weight with RYGB than with SG or AGB at 1, 3, and 5 years; however, RYGB had the highest 30-day rate of major adverse events. Small subgroup differences in weight loss outcomes were observed. Primary funding source Patient-Centered Outcomes Research Institute.

Problem Engaging communities in research increases its relevance and may speed the translation of discoveries into improved health outcomes. Many researchers lack training to effectively engage stakeholders, whereas academic institutions lack infrastructure to support community engagement. Approach In 2009, the Meharry-Vanderbilt Community-Engaged Research Core began testing new approaches for community engagement, which led to the development of the Community Engagement Studio (CE Studio). This structured program facilitates project-specific input from community and patient stakeholders to enhance research design, implementation, and dissemination. Developers used a team approach to recruit and train stakeholders, prepare researchers to engage with stakeholders, and facilitate an in-person meeting with both. Outcomes The research core has implemented 28 CE Studios that engaged 152 community stakeholders. Participating researchers, representing a broad range of faculty ranks and disciplines, reported that input from stakeholders was valuable and that the CE Studio helped determine project feasibility and enhanced research design and implementation. Stakeholders found the CE Studio to be an acceptable method of engagement and reported a better understanding of research in general. A tool kit was developed to replicate this model and to disseminate this approach. Next Steps The research core will collect data to better understand the impact of CE Studios on research proposal submissions, funding, research outcomes, patient and stakeholder engagement in projects, and dissemination of results. They will also collect data to determine whether CE Studios increase patient-centered approaches in research and whether stakeholders who participate have more trust and willingness to participate in research.

Importance Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM. Objective To evaluate associations of bariatric surgery with T2DM outcomes. Design, Setting, and Participants This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019. Interventions Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Main Outcome and Measures Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c). Results A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1cwas reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG. Conclusions and Relevance In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

Importance Additional data comparing longer-term problems associated with various bariatric surgical procedures are needed for shared decision-making. Objective To compare the risks of intervention, operation, endoscopy, hospitalization, and mortality up to 5 years after 2 bariatric surgical procedures. Design, Setting, and Participants Adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2005, and September 30, 2015, within the National Patient-Centered Clinical Research Network. Data from 33 560 adults at 10 centers within 4 clinical data research networks were included in this cohort study. Information was extracted from electronic health records using a common data model and linked to insurance claims and mortality indices. Analyses were conducted from January 2018 through October 2019. Exposures Bariatric surgical procedures. Main Outcomes and Measures The primary outcome was time until operation or intervention. Secondary outcomes included endoscopy, hospitalization, and mortality rates. Results Of 33 560 adults, 18 056 (54%) underwent RYGB, and 15 504 (46%) underwent SG. The median (interquartile range) follow-up for operation or intervention was 3.4 (1.6-5.0) years for RYGB and 2.2 (0.9-3.6) years for SG. The overall mean (SD) patient age was 45.0 (11.5) years, and the overall mean (SD) patient body mass index was 49.1 (7.9). The cohort was composed predominantly of women (80%) and white individuals (66%), with 26% of Hispanic ethnicity. Operation or intervention was less likely for SG than for RYGB (hazard ratio, 0.72; 95% CI, 0.65-0.79;P Conclusions and Relevance Interventions, operations, and hospitalizations were relatively common after bariatric surgical procedures and were more often associated with RYGB than SG. Trial Registration ClinicalTrials.gov identifier:NCT02741674

Background Bariatric surgery has been used for treatment of severe obesity in adolescents but most studies have been small and limited in follow-up. Objectives We hypothesized that electronic health record data could be used to compare effectiveness of bariatric procedures in adolescents. Setting Data were obtained from clinical research networks using a common data model to extract data from each site. Methods Adolescents who underwent a primary bariatric procedure from 2005 through 2015 were identified. The percent change in body mass index (BMI) at 1, 3, and 5 years was estimated using random effects linear regression for patients undergoing all operations. Propensity score adjusted estimates and 95% confidence intervals were estimated for procedures with >25 patients at each time period. Results This cohort of 544 adolescents was predominantly female (79%) and White (66%), with mean (±standard deviation) age of 17.3 (±1.6) years and mean BMI of 49.8 (± 7.8) kg/m2. Procedures included Roux-en-Y gastric bypass (RYGB; n = 177), sleeve gastrectomy (SG; n = 306), and laparoscopic adjustable gastric banding (n = 61). For those undergoing RYGB, SG, and laparoscopic adjustable gastric banding, mean (95% confidence interval) BMI changes of −31% (−30% to −33%), −28% (−27% to −29%), and −10% (−8% to −12%), were estimated at 1 year. For RYGB and SG, BMI changes of −29% (−26% to −33%) and −25% (−22% to −28%) were estimated at 3 years. Conclusions Adolescents undergoing SG and RYGB experienced greater declines in BMI at 1- and 3-year follow-up time points, while laparoscopic adjustable gastric banding was significantly less effective for BMI reduction. (Surg Obes Relat Dis 2018;000:1–13.)

Purpose The objective of this study was to report survey response rates and demographic characteristics of eight recruitment approaches to determine acceptability and effectiveness of large-scale patient recruitment among various populations. Methods We conducted a cross sectional analysis of survey data from two large cohorts. Patients were recruited from the Mid-South Clinical Data Research Network using clinic-based recruitment, research registries, and mail, phone, and email approaches. Response rates are reported as patients who consented for the survey divided by the number of eligible patients approached. Results We contacted more than 90,000 patients and 13,197 patients completed surveys. Median age was 56.3 years (IQR 40.9, 67.4). Racial/ethnic distribution was 84.1% White, non-Hispanic; 9.9% Black, non-Hispanic; 1.8% Hispanic; and 4.0% other, non-Hispanic. Face-to-face recruitment had the highest response rate of 94.3%, followed by participants who “opted-in” to a registry (76%). The lowest response rate was for unsolicited emails from the clinic (6.1%). Face-to-face recruitment enrolled a higher percentage of participants who self-identified as Black, non-Hispanic compared to other approaches (18.6% face-to-face vs. 8.4% for email). Conclusions Technology-enabled recruitment approaches such as registries and emails are effective for recruiting but may yield less racial/ethnic diversity compared to traditional, more time-intensive approaches.

Objectives To understand the formal roles of community representatives (CRs) in Clinical and Translational Science Awardee (CTSA) activities, to evaluate the extent of integration into the organizational and governance structures and to identify barriers to effective integration. Methods The inventory tool was distributed to each of the 60 CTSAs using a secure web application. Results Forty-seven (78%) completed the inventory. The mean number of CRs per CTSA is 21.4 (SD: 14.8). Most CTSAs had community advisory boards (89%) and 94% included CRs in Community Engagement (CE) cores. Only 11% reported a CR being a member of the CTSA leadership team and 19% reported that CRs advise core programs beyond CE. CRs are compensated by 79% of CTSAs. Mean annual compensation is $753 (median: $400). Compensation directly correlated with the number of hours that CRs worked in CTSA activities (r = 0.64; P = 0.001). Conclusions This inventory allows CTSAs to better understand how CRs have engaged in activities and brings attention to the limited representation among cores and in leadership roles. CTSAs should, with substantive input from CRs, develop strategies to provide the resources and compensation necessary to better integrate the community in CTSA activities and fully realize the goals of the CTSA vision.

OBJECTIVES/SPECIFIC AIMS: Community stakeholder engagement along the translational spectrum of biomedical research has been identified as a potentially crucial factor for encouraging participation among underrepresented groups, improving research relevance, and adoption of evidence into practice. Although we have developed various methods to improve communication between researchers and community stakeholders, we have not focused much attention on the manner by which community stakeholders choose to communicate with researchers in scientific feedback settings. In our PCORI funded study using Community Engagement Studios to elicit feedback on research from community stakeholders, we found that feedback from participants was frequently provided in the form of stories. This presentation aims to describe these narratives, examine their function in the feedback process and consider how a focus on these narratives enhances our understanding of community engagement for clinical and translational research. METHODS/STUDY POPULATION: The present study comes from a larger randomized, controlled methodological study. We randomized 20 investigators seeking input on their research to either a Community Engagement Studio (a panel of community members or patients) or a Translational Studio (a panel of researchers). Any faculty member or research trainee at Vanderbilt University or Meharry Medical College was eligible to participate. Each Studio panel was convened to provide project-specific input. The 153 stakeholders who participated in CE Studios were patients, caregivers, or patient advocates identified by health status, health condition, or demographic variables based on the project-based needs of the 20 researchers randomized in this project. Stakeholders include individuals with diabetes, heart failure, Parkinson’s disease, sickle cell disease, and ICU survivors. All stakeholders had experience as a partner or consultant on a research project or through serving on a research advisory board or committee. All Studios were recorded and transcribed, and experienced qualitative researchers analyzed the data. For this paper, we focus on the narrative feedback in the form of stories elicited in the CE Studios. Using qualitative methods, we coded the transcripts from the 20 CE Studios to identify stories and their functions in the feedback. Stories were defined as narratives with (a) at least one actor (b) action that unfolds over time, and (c) a realization, destination, or conflict resolution (i.e., a point of the story). For example, “I refilled my mother’s pillbox on Sunday and on Friday I found the pillbox still completely full” would be a story, however, “my mother doesn’t take her meds correctly” would not. We coded the stories for how they facilitated communication in the Studio using an open-coding style, that is we did not apply a specific theoretical framework of interaction or communication. It was possible for any given story to have more than one code applied to it; that is they were not classified in a mutually exclusive way. RESULTS/ANTICIPATED RESULTS: We found 5 major functions of stories in the Studios. Basic sender-receiver functions were noted, including responding to queries and seeking mutual understanding. The other functions served to move or add to the conversation, including adding expansion and depth, characterizing abstract concepts, and providing context, with the latter being the most frequent function of stories. Speakers provided context in a wide variety of dimensions, ranging from the context of the body to spatial and institutional contexts. These stories served to help others understand the speakers’ lived experiences. DISCUSSION/SIGNIFICANCE OF IMPACT: We often engage community members in research for their expertise with regards to their lived experiences as patients or community members, and for their experiences of healthcare and social determinants of health in particular community contexts. Yet we may expect them to share their expertise in a manner that is consistent with a scientific, explanatory framing and language. However, we know there is a difference in the way that professional researchers discuss research Versus how community members discuss research. In our PCORI study, we found that our Community Studio participants relied on storytelling as an important means to communicate their lived experiences. Their stories were often key to communicating the complex contexts of their experiences. We focus on examining these narrative practices and their functions in how community members engaged with and provided advice to researchers. This understanding may help us in: (1) Characterizing the contexts, processes, and meanings associated with community stakeholder experiences that are otherwise difficult to access. (2) Identifying community priorities relevant to research that are embedded in community narratives to better align research priorities with community needs and to improve patient outcomes. (3) Collecting insights for improving the design of community engagement activities in research. (4) Harnessing more fully the potential of community engagement in research.

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

Scanning-electron-beam lithography has not been generally accepted for the direct writing of patterns on wafers, primarily because of the time required for a single beam to scan a production-sized wafer (100 to 150 mm in diameter). This paper reports progress on a scheme for multiple-beam lithography using an immersion screen lens to overcome the time problem. In this approach, each die of the wafer has its own writing beam. All the beams are scanned and blanked in parallel so that identical patterns are written simultaneously over all dice. A laser interferometer stage under computer control enables dice of large area to be completely covered, despite limitations on the deflection amplitude of the beamlets. It is shown that a 1-min cycle time is practical using PBS resist. Preliminary results from an experimental machine based on these principles are given.