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Background The gap between the supply of organs available for transplantation and demand is growing, especially among ethnic groups. Objective To evaluate the effect of a video designed to address concerns of ethnic groups about organ donation. Design Cluster randomized, controlled trial. Randomization was performed by using a random-number table with centralized allocation concealment. Participants and investigators assessing outcomes were not blinded to group assignment. (ClinicalTrials.gov registration number: NCT00870506) Setting Twelve branches of the Ohio Bureau of Motor Vehicles in northeastern Ohio. Participants 952 participants aged 15 to 66 years. Intervention Video (intervention; n = 443) or usual Bureau of Motor Vehicles license practices (control; n = 509). Measurements The primary outcome was the proportion of participants who provided consent for organ donation on a newly acquired driver’s license, learner’s permit, or state identification card. Secondary outcomes included willingness to make a living kidney donation to a family member in need and personal beliefs about donation. Results More participants who viewed the video consented to donate organs than control participants (84% vs. 72%; difference, 12 percentage points [95% CI, 6 to 17 percentage points]). The video was effective among black participants (76% vs. 54%; difference, 22 percentage points [CI, 9 to 35 percentage points]) and white participants (88% vs. 77%; difference, 11 percentage points [CI, 5 to 15 percentage points]). At the end of the trial, fewer intervention than control participants reported having insufficient information about organ donation (34% vs. 44%; difference, −10 percentage points [CI, −16 to −4 percentage points]), wanting to be buried with all of their organs (14% vs. 25%; difference, −11 percentage points [CI, −16 to −6 percentage points]), and having conflicts with organ donation (7% vs. 11%; difference, −4 percentage points [CI, −8 to −2 percentage points]). Limitation How the observed increases in consent to donate organs might translate into a greater organ supply in the region is unclear. Conclusion Exposure to a brief video addressing concerns that ethnic groups have about organ donation just before obtaining a license, permit, or identification card increased consent to donate organs among white and black participants. Primary Funding Source National Institutes of Health and the Robert Wood Johnson Foundation.

Key PointsQuestionIs the functional medicine model of care associated with patient-reported health-related quality of life?FindingsIn this cohort study of 7252 eligible patients (functional medicine center: 1595; family health center: 5657), functional medicine patients exhibited significantly larger improvements in Patient-Reported Outcome Measurement Information System Global Physical Health at 6 months than propensity-matched patients at a family health center (398 matched pairs). Improvements in Patient-Reported Outcome Measurement Information System Global Physical Health appeared to be sustained at 12 months but not significantly different from those at the family health center.MeaningThe findings of this study suggest that functional medicine may have the ability to improve global health in patients.

Background: More than 60 years since the discovery of the respiratory syncytial virus (RSV), the effects of prenatal exposure to this virus remain largely unknown. In this investigation, we sought to find evidence of RSV seroconversion in cord blood and explore its clinical implications for the newborn. Methods: Offspring from 22 pregnant women with a history of viral respiratory infection during the third trimester of pregnancy (respiratory viral illness [RVI] group) and 40 controls were enrolled in this study between 1 September 2016 and 31 March 2019. Cord blood sera were tested for anti-RSV antibodies by indirect fluorescent antibody assay. RSV seropositivity was defined as the presence of anti-RSV immunoglobulin M (IgM) or immunoglobulin A (IgA), in addition to IgG in cord blood serum at ≥1:20 dilution. Results: Anti-RSV IgG was present in all cord blood serum samples from infants born to RVI mothers (95% confidence interval [CI] = 82%-100%), with 16 samples also having elevated titers for either anti-RSV IgA or IgM (73%; 95% CI = 52%-87%). No controls had evidence of anti-RSV antibodies. Eight (50%) seropositive newborns developed at least one respiratory tract finding, including respiratory distress syndrome (N = 8), respiratory failure (N = 3), and pneumonia (N = 1). RSV seropositive newborns also required more days on oxygen, had leukocytosis and elevated C-reactive protein (P = .025, P = .047, and P < .001, respectively). Conclusion: This study provides evidence of acute seropositivity against RSV in cord blood of newborns delivered from mothers with a history of upper respiratory tract illness in the third trimester. Cord blood seropositivity for anti-RSV IgA or IgM was associated with adverse clinical and laboratory outcomes in newborns.

ObjectiveTo compare outcomes and costs associated with functional medicine-based care delivered in a shared medical appointment (SMA) to those delivered through individual appointments.DesignA retrospective cohort study was performed to assess outcomes and cost to deliver care to patients in SMAs and compared with Propensity Score (PS)-matched patients in individual appointments.SettingA single-centre study performed at Cleveland Clinic Center for Functional Medicine.ParticipantsA total of 9778 patients were assessed for eligibility and 7323 excluded. The sample included 2455 patients (226 SMAs and 2229 individual appointments) aged ≥18 years who participated in in-person SMAs or individual appointments between 1 March 2017 and 31 December 2019. Patients had a baseline Patient-Reported Outcome Measurement Information System (PROMIS) Global Physical Health (GPH) score and follow-up score at 3 months. Patients were PS-matched 1:1 with 213 per group based on age, sex, race, marital status, income, weight, body mass index, blood pressure (BP), PROMIS score and functional medicine diagnostic category.Primary and secondary outcome measuresThe primary outcome was change in PROMIS GPH at 3 months. Secondary outcomes included change in PROMIS Global Mental Health (GMH), biometrics, and cost.ResultsAmong 213 PS-matched pairs, patients in SMAs exhibited greater improvements at 3 months in PROMIS GPH T-scores (mean difference 1.18 (95% CI 0.14 to 2.22), p=0.03) and PROMIS GMH T-scores (mean difference 1.78 (95% CI 0.66 to 2.89), p=0.002) than patients in individual appointments. SMA patients also experienced greater weight loss (kg) than patients in individual appointments (mean difference −1.4 (95% CI −2.15 to −0.64), p<0.001). Both groups experienced a 5.5 mm Hg improvement in systolic BP. SMAs were also less costly to deliver than individual appointments.ConclusionSMAs deliver functional medicine-based care that improves outcomes more than care delivered in individual appointments and is less costly to deliver.

The statements and opinions expressed in COVID-19 Curbside Consults are based on experience and the available literature as of the date posted. While we try to regularly update this content, any offered recommendations cannot be substituted for the clinical judgment of clinicians caring for individual patients.

Background In order to address disparities in preventable chronic diseases, we adapted a nutrition and lifestyle-focused shared medical appointment (SMA) program to be delivered in an underserved community setting. The objective was to evaluate a community-based nutrition and lifestyle-focused SMA as it relates to acceptability and health and behavior-related outcomes. Methods A mixed-methods study was performed to evaluate pre-post changes in wellness indices, biometrics, self-efficacy, and trust in medical researchers as part of a community-based SMA. To understand program acceptability including barriers and facilitators for implementation and scalability, we conducted two participant focus groups and five stakeholder interviews and used content analysis to determine major themes. Results Fifteen participants attended 10 weekly sessions. The majority were older adult, African American women. There were pre-post improvements in mean [SD] systolic (-10.5 [7.7] mmHg, p = 0.0001) and diastolic (-4.7 [6.7] mmHg, p = 0.17) blood pressures and weight (-5.7 [6.3] pounds, p = 0.003) at 3 months though these were not significant at 6 months. More individuals reported improvements in health status, daily fruit and vegetable intake, and sleep than at baseline. There were no significant pre-post changes in other wellness indices, self-efficacy, trust in medical researchers, hemoglobin A1c, insulin, or LDL cholesterol. Participants discussed positive health changes as a result of the SMA program, program preferences, and facilitators and barriers to continuing program recommendations in focus groups. SMA implementation was facilitated by clinical staff who adjusted content to a low health literacy group and partnership with a trusted community partner. Sustainability barriers include heavy personnel time and in-kind resources to deliver the program. Conclusions Nutrition and lifestyle-focused SMAs in a resource-challenged community setting may be an acceptable intervention for underserved patients.

Background: In order to address disparities in preventable chronic diseases, we adapted a nutrition and lifestyle focused shared medical appointment (SMA) program to be delivered in an underserved community setting. The objective was to determine the feasibility of the community-based SMA pilot.Methods: The SMA program was a community benefit for community residents regardless of their participation in the research study. We evaluated pre-post changes in wellness indices, biometrics, self-efficacy, and trust in medical researchers. To understand the barriers and facilitators for implementation and scalability, we conducted two participant focus groups and five stakeholder interviews and used content analysis to determine major themes. Key Results: Fifteen participants attended 10 weekly sessions. The majority were older adult, African American women. There were pre-post improvements in mean systolic (-10.5 [7.7] mmHg, p=0.0001) and diastolic (-4.7 [6.7] mmgHg, p=0.17) blood pressures and weight (-5.7 [6.3] pounds, p=0.0034) at 3 months though these were not significant at 6 months. More individuals reported improvements in health status, daily fruit and vegetable intake, and sleep than at baseline. There were no significant pre-post changes in other wellness indices, self-efficacy, trust in medical researchers, hemoglobin A1c, insulin, or LDL cholesterol. Participants discussed positive health changes as a result of the SMA program, program preferences, and facilitators and barriers to continuing program recommendations in focus groups. SMA implementation was facilitated by clinical staff who adjusted content to a low health literacy group and partnership with a trusted community partner. Sustainability barriers include heavy personnel time and in-kind resources to deliver the program. Conclusion: Lifestyle-focused community-based SMAs can be a feasible and acceptable intervention for patients with neighborhood disadvantage, especially in partnership with trusted organizations.