Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials.

Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.

Prevalence and Predictors of Household Food Insecurity and Supplemental Nutrition Assistance Program Use in Youth and Young Adults With Diabetes: The SEARCH for Diabetes in Youth Study.

OBJECTIVE: To assess the prevalence of household food insecurity (HFI) and Supplemental Nutrition Assistance Program (SNAP) participation among youth and young adults (YYA) with diabetes overall and by type, and sociodemographic characteristics. RESEARCH DESIGN AND METHODS: The study included participants with youth-onset type 1 diabetes and type 2 diabetes from the SEARCH for Diabetes in Youth study. HFI was assessed using the 18-item U.S. Household Food Security Survey Module (HFSSM) administered from 2016 to 2019; three or more affirmations on the HFSSM were considered indicative of HFI. Participants were asked about SNAP participation. We used χ2 tests to assess whether the prevalence of HFI and SNAP participation differed by diabetes type. Multivariable logistic regression models were used to examine differences in HFI by participant characteristics. RESULTS: Of 2,561 respondents (age range, 10-35 years; 79.6% ≤25 years), 2,177 had type 1 diabetes (mean age, 21.0 years; 71.8% non-Hispanic White, 11.8% non-Hispanic Black, 13.3% Hispanic, and 3.1% other) and 384 had type 2 diabetes (mean age, 24.7 years; 18.8% non-Hispanic White, 45.8% non-Hispanic Black, 23.7% Hispanic, and 18.7% other). The overall prevalence of HFI was 19.7% (95% CI 18.1, 21.2). HFI was more prevalent in type 2 diabetes than type 1 diabetes (30.7% vs. 17.7%; P < 0.01). In multivariable regression models, YYA receiving Medicaid or Medicare or without insurance, whose parents had lower levels of education, and with lower household income had greater odds of experiencing HFI. SNAP participation was 14.1% (95% CI 12.7, 15.5), with greater participation among those with type 2 diabetes compared with those with type 1 diabetes (34.8% vs. 10.7%; P < 0.001). CONCLUSIONS: Almost one in three YYA with type 2 diabetes and more than one in six with type 1 diabetes reported HFI in the past year-a significantly higher prevalence than in the general U.S. population.

Primary Care Counseling of Parents Regarding Childhood Screen Media Use.

Parental beliefs and motivation are instrumental in improving childhood digital media use (DMU). Parents (n = 611) completed questionnaires about childhood DMU assessing knowledge, interest in counseling, motivation to change, self-efficacy, and beliefs. Less than a third correctly recognized screen time limits. Twenty-seven percent received childhood DMU information from a doctor, while 46% stated they would like such information. Only 2% had a doctor-recommended DMU plan. Interest in DMU topics, motivation to improve, and management self-efficacy were moderate. Top negative beliefs were addiction to DMU (52%), sleep problems (39%), obesity (33%), social skills (33%), and inappropriate content (32%). Differences between age categories existed for social (48%, P = .01) and language (14%, P = .01) concerns (highest for toddlers), attention concerns (27%, P = .02; highest in preschoolers), and depression (13%, P < .001) and low self-esteem (8%, P = .04; highest in teens). Findings support further development of approaches to address DMU, tailored by age-specific common parental views.

Feasibility of Post-hospitalization Telemedicine Video Visits for Children With Medical Complexity.

OBJECTIVES: To evaluate feasibility and acceptability of post-hospitalization telemedicine video visits (TMVV) during hospital-to-home transitions for children with medical complexity (CMC); and explore associations with hospital utilization, caregiver self-efficacy (CSE), and family self-management (FSM). METHOD: This non-randomized pilot study assigned CMC (n=28) to weekly TMVV for four weeks post-hospitalization; control CMC (n=20) received usual care without telemedicine. Feasibility was measured by time to connection and proportion of TMVV completed; acceptability was measured by parent-reported surveys. Pre/post-discharge changes in CSE, FSM, and hospital utilization were assessed. RESULTS: 64 TMVV were completed; 82 % of patients completed 1 TMVV; 54 % completed four TMVV. Median time to TMVV connection was 1 minute (IQR=2.5). Parents reported high acceptability of TMVV (mean 6.42; 1 -7 scale). CSE and FSM pre/post-discharge were similar for both groups; utilization declined in both groups post-discharge. DISCUSSION: Post-hospitalization TMVV for CMC were feasible and acceptable during hospital-to-home transitions.

Regional and sociodemographic differences in average BMI among US children in the ECHO program.

OBJECTIVE: The aim of this study was to describe the association of individual-level characteristics (sex, race/ethnicity, birth weight, maternal education) with child BMI within each US Census region and variation in child BMI by region. METHODS: This study used pooled data from 25 prospective cohort studies. Region of residence (Northeast, Midwest, South, West) was based on residential zip codes. Age- and sex-specific BMI z scores were the outcome. RESULTS: The final sample included 14,313 children with 85,428 BMI measurements, 49% female and 51% non-Hispanic White. Males had a lower average BMI z score compared with females in the Midwest (ß = -0.12, 95% CI: -0.19 to -0.05) and West (ß = -0.12, 95% CI: -0.20 to -0.04). Compared with non-Hispanic White children, BMI z score was generally higher among children who were Hispanic and Black but not across all regions. Compared with the Northeast, average BMI z score was significantly higher in the Midwest (ß = 0.09, 95% CI: 0.05 to 0.14) and lower in the South (ß = -0.12, 95% CI: -0.16 to -0.08) and West (ß = -0.14, 95% CI: -0.19 to -0.09) after adjustment for age, sex, race/ethnicity, and birth weight. CONCLUSIONS: Region of residence was associated with child BMI z scores, even after adjustment for sociodemographic characteristics. Understanding regional influences can inform targeted efforts to mitigate BMI-related disparities among children.

Capacity Building for a New Multicenter Network Within the ECHO IDeA States Pediatric Clinical Trials Network.

Introduction: Research capacity building is a critical component of professional development for pediatrician scientists, yet this process has been elusive in the literature. The ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) seeks to implement pediatric trials across medically underserved and rural populations. A key component of achieving this objective is building pediatric research capacity, including enhancement of infrastructure and faculty development. This article presents findings from a site assessment inventory completed during the initial year of the ISPCTN. Methods: An assessment inventory was developed for surveying ISPCTN sites. The inventory captured site-level activities designed to increase clinical trial research capacity for pediatrician scientists and team members. The inventory findings were utilized by the ISPCTN Data Coordinating and Operations Center to construct training modules covering 3 broad domains: Faculty/coordinator development; Infrastructure; Trials/Research concept development. Results: Key lessons learned reveal substantial participation in the training modules, the importance of an inventory to guide the development of trainings, and recognizing local barriers to clinical trials research. Conclusions: Research networks that seek to implement successfully completed trials need to build capacity across and within the sites engaged. Our findings indicate that building research capacity is a multi-faceted endeavor, but likely necessary for sustainability of a unique network addressing high impact pediatric health problems. The ISPCTN emphasis on building and enhancing site capacity, including pediatrician scientists and team members, is critical to successful trial implementation/completion and the production of findings that enhance the lives of children and families.

Glycemic control is associated with dyslipidemia over time in youth with type 2 diabetes: The SEARCH for diabetes in youth study.

BACKGROUND: Dyslipidemia has been documented in youth with type 2 diabetes. There is a paucity of studies examining dyslipidemia over time in youth with type 2 diabetes and associated risk factors. OBJECTIVE: To evaluate lipids at baseline and follow-up and associated risk factors in youth with type 2 diabetes. METHODS: We studied 212 youth with type 2 diabetes at baseline and after an average of 7 years of follow-up in the SEARCH for Diabetes in Youth Study. Abnormal lipids were defined as high-density lipoprotein cholesterol (HDL-C) < 35, low-density lipoprotein cholesterol (LDL-C) > 100, or triglycerides >150 (all mg/dl). We evaluated participants for progression to abnormal lipids (normal lipids at baseline and abnormal at follow-up), regression (abnormal lipids at baseline and normal at follow-up), stable normal, and stable abnormal lipids over time for HDL-C, LDL-C, and triglycerides. Associations between hemoglobin A1c (HbA1c) and adiposity over time (area under the curve [AUC]) with progression and stable abnormal lipids were evaluated. RESULTS: HDL-C progressed, regressed, was stable normal, and stable abnormal in 12.3%, 11.3%, 62.3%, and 14.2% of participants, respectively. Corresponding LDL-C percentages were 15.6%, 12.7%, 42.9%, and 28.8% and triglycerides were 17.5%, 10.8%, 55.7%, and 16.0%. Each 1% increase in HbA1c AUC was associated with a 13% higher risk of progression and stable abnormal triglycerides and a 20% higher risk of progression and stable abnormal LDL-C. Higher adiposity AUC was marginally (p = 0.049) associated with abnormal HDL-C. CONCLUSIONS: Progression and stable abnormal LDL-C and triglycerides occur in youth with type 2 diabetes and are associated with higher HbA1c.

Site-Level Variation in the Characteristics and Care of Infants With Neonatal Opioid Withdrawal.

BACKGROUND AND OBJECTIVES: Variation in pediatric medical care is common and contributes to differences in patient outcomes. Site-to-site variation in the characteristics and care of infants with neonatal opioid withdrawal syndrome (NOWS) has yet to be quantified. Our objective was to describe site-to-site variation in maternal-infant characteristics, infant management, and outcomes for infants with NOWS. METHODS: Cross-sectional study of 1377 infants born between July 1, 2016, and June 30, 2017, who were ≥36 weeks' gestation, with NOWS (evidence of opioid exposure and NOWS scoring within the first 120 hours of life) born at or transferred to 1 of 30 participating hospitals nationwide. Site-to-site variation for each parameter within the 3 domains was measured as the range of individual site-level means, medians, or proportions. RESULTS: Sites varied widely in the proportion of infants whose mothers received adequate prenatal care (31.3%-100%), medication-assisted treatment (5.9%-100%), and prenatal counseling (1.9%-75.5%). Sites varied in the proportion of infants with toxicology screening (50%-100%) and proportion of infants receiving pharmacologic therapy (6.7%-100%), secondary medications (1.1%-69.2%), and nonpharmacologic interventions including fortified feeds (2.9%-90%) and maternal breast milk (22.2%-83.3%). The mean length of stay varied across sites (2-28.8 days), as did the proportion of infants discharged with their parents (33.3%-91.1%). CONCLUSIONS: Considerable site-to-site variation exists in all 3 domains. The magnitude of the observed variation makes it unlikely that all infants are receiving efficient and effective care for NOWS. This variation should be considered in future clinical trial development, practice implementation, and policy development.

Detection of Diabetes Status and Type in Youth Using Electronic Health Records: The SEARCH for Diabetes in Youth Study.

OBJECTIVE: Diabetes surveillance often requires manual medical chart reviews to confirm status and type. This project aimed to create an electronic health record (EHR)-based procedure for improving surveillance efficiency through automation of case identification. RESEARCH DESIGN AND METHODS: Youth (<20 years old) with potential evidence of diabetes (N = 8,682) were identified from EHRs at three children's hospitals participating in the SEARCH for Diabetes in Youth Study. True diabetes status/type was determined by manual chart reviews. Multinomial regression was compared with an ICD-10 rule-based algorithm in the ability to correctly identify diabetes status and type. Subsequently, the investigators evaluated a scenario of combining the rule-based algorithm with targeted chart reviews where the algorithm performed poorly. RESULTS: The sample included 5,308 true cases (89.2% type 1 diabetes). The rule-based algorithm outperformed regression for overall accuracy (0.955 vs. 0.936). Type 1 diabetes was classified well by both methods: sensitivity (Se) (>0.95), specificity (Sp) (>0.96), and positive predictive value (PPV) (>0.97). In contrast, the PPVs for type 2 diabetes were 0.642 and 0.778 for the rule-based algorithm and the multinomial regression, respectively. Combination of the rule-based method with chart reviews (n = 695, 7.9%) of persons predicted to have non-type 1 diabetes resulted in perfect PPV for the cases reviewed while increasing overall accuracy (0.983). The Se, Sp, and PPV for type 2 diabetes using the combined method were ≥0.91. CONCLUSIONS: An ICD-10 algorithm combined with targeted chart reviews accurately identified diabetes status/type and could be an attractive option for diabetes surveillance in youth.

Longitudinal association of biomarkers of pesticide exposure with cardiovascular disease risk factors in youth with diabetes.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death among individuals with diabetes, but little is known about the role of exposures to environmental chemicals such as pesticides in the early development of CVD risk in this population. OBJECTIVES: To describe changes over time in concentrations of pesticide biomarkers among youth with diabetes in the United States and to estimate the longitudinal association between these concentrations and established risk factors for CVD. METHODS: Pesticide biomarkers were quantified in urine and serum samples from 87 youth with diabetes participating in the multi-center SEARCH cohort study. Samples were obtained around the time of diagnosis (baseline visit, between 2006 and 2010) and, on average, 5.4 years later (follow-up visit, between 2012 and 2015). We calculated geometric mean (95% CI) pesticide biomarker concentrations. Eight CVD risk factors were measured at these two time points: body mass index (BMI) z-score, HbA1c, insulin sensitivity, fasting C-peptide (FCP), LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides. Linear regression models were used to estimate the associations between each pesticide biomarker at baseline and each CVD risk factor at follow-up, adjusting for baseline health outcome, elapsed time between baseline and follow up, sex, age, race/ethnicity, and diabetes type. RESULTS: Participants were, on average, 14.2 years old at their baseline visit, and most were diagnosed with type 1 diabetes (57.5%). 4-nitrophenol, 3-phenoxybenzoic acid, 2,4-dichlorophenoxyacetic acid (2,4-D), 3,5,6-trichloro-2-pyridinol, 2,2-bis(4-chlorophenyl)-1,1-dichloroethene, and hexachlorobenzene were detected in a majority of participants at both time points. Participants in the highest quartile of 2,4-D and 4-nitrophenol at baseline had HbA1c levels at follow-up that were 1.05 percentage points (95% CI: -0.40, 2.51) and 1.27 percentage points (0.22, 2.75) higher, respectively, than participants in the lowest quartile of these pesticide biomarkers at baseline. These participants also had lower log FCP levels (indicating reduced beta-cell function) compared to participants in the lowest quartile at baseline: beta (95% CI) for log FCP of -0.64 (-1.17, -0.11) for 2,4-D and -0.39 (-0.96, 0.18) for 4-nitrophenol. In other words, participants in the highest quartile of 2,4-D had a 47.3% lower FCP level compared to participants in the lowest quartile, and those in the highest quartile of 4-nitrophenol had a 32.3% lower FCP level than those in the lowest quartile. Participants with trans-nonachlor concentrations in the highest quartile at baseline had HbA1c levels that were 1.45 percentage points (-0.11, 3.01) higher and log FCP levels that were -0.28 (-0.84, 0.28) lower than participants in the lowest quartile at baseline, that is to say, participants in the highest quartile of trans-nonachlor had a 24.4% lower FCP level than those in the lowest quartile. While not all of these results were statistically significant, potentially due to the small same size, clinically, there appears to be quantitative differences. No associations were observed between any pesticide biomarker at baseline with BMI z-score or insulin sensitivity at follow-up. CONCLUSIONS: Exposure to select pesticides may be associated with impaired beta-cell function and poorer glycemic control among youth with diabetes.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome.

OBJECTIVES: The incidence of neonatal opioid withdrawal syndrome (NOWS) has increased fivefold over the last 10 years. Standardized NOWS care protocols have revealed many improved patient outcomes. Our objective for this study is to describe results of a clinical practice survey of NOWS management practices designed to inform future clinical studies in the diagnosis and management of NOWS. METHODS: A cross-sectional survey was administered to medical unit directors at 32 Institutional Development Award States Pediatric Clinical Trial Network and 22 Neonatal Research Network sites in the fall of 2017. Results are presented as both the number and percentage of positive responses. Ninety-five percent Wilson confidence intervals (CIs) were generated around estimates, and χ2 and Fisher's exact tests were used to compare the association between unit type and reporting of each protocol. RESULTS: Sixty-two responses representing 54 medical centers were received. Most participating NICU and non-ICU sites reported protocols for NOWS management, including NOWS scoring (98% NICU; 86% non-ICU), pharmacologic treatment (92% NICU; 64% non-ICU), and nonpharmacologic care (79% NICU; 79% non-ICU). Standardized protocols for pharmacologic care and weaning were reported more frequently in the NICU (92% [95% CI: 80%-97%] and 94% [95% CI: 83%-98%], respectively) compared with non-ICU settings (64% [95% CI: 39%-84%] for both) (P < .05 for both comparisons). Most medical centers reported morphine as first-line therapy (82%; 95% CI: 69%-90%) and level 3 and level 4 NICUs as the location of pharmacologic treatment (83%; 95% CI: 71%-91%). CONCLUSIONS: Observed variations in care between NICUs and non-ICUs revealed opportunities for targeted interventions in training and standardized care plans in non-ICU sites.

Health care access and glycemic control in youth and young adults with type 1 and type 2 diabetes in South Carolina.

Affordability and geographic accessibility are key health care access characteristics. We used data from 481 youth and young adults (YYA) with diabetes (389 type 1, 92 type 2) to understand the association between health care access and glycemic control as measured by HbA1c values. In multivariate models, YYA with state or federal health insurance had HbA1c percentage values 0.68 higher (P = 0.0025) than the privately insured, and those without insurance 1.34 higher (P < 0.0001). Not having a routine diabetes care provider was associated with a 0.51 higher HbA1c (P = 0.048) compared to having specialist care, but HbA1c did not differ significantly (P = 0.069) between primary vs specialty care. Distance to utilized provider was not associated with HbA1c among YYA with a provider (P = 0.11). These findings underscore the central role of health insurance and indicate a need to better understand the root causes of poorer glycemic control in YYA with state/federal insurance.

Statewide Longitudinal Progression of the Whole-Patient Measure of Safety in South Carolina.

Meaningful improvement in patient safety encompasses a vast number of quality metrics, but a single measure to represent the overall level of safety is challenging to produce. Recently, Perla et al. established the Whole-Person Measure of Safety (WPMoS) to reflect the concept of global risk assessment at the patient level. We evaluated the WPMoS across an entire state to understand the impact of urban/rural setting, academic status, and hospital size on patient safety outcomes. The population included all South Carolina (SC) inpatient discharges from January 1, 2008, through to December 31, 2013, and was evaluated using established definitions of highly undesirable events (HUEs). Over the study period, the proportion of hospital discharges with at least one HUE significantly decreased from 9.7% to 8.8%, including significant reductions in nine of the 14 HUEs. Academic, large, and urban hospitals had a significantly lower proportion of hospital discharges with at least one HUE in 2008, but only urban hospitals remained significantly lower by 2013. Results indicate that there has been a decrease in harm events captured through administrative coded data over this 6-year period. A composite measure, such as the WPMoS, is necessary for hospitals to evaluate their progress toward reducing preventable harm.

Differences in Hospital Readmission Risk across All Payer Groups in South Carolina.

OBJECTIVE: To evaluate differences in hospital readmission risk across all payers in South Carolina (SC). DATA SOURCES/STUDY SETTING: South Carolina Revenue and Fiscal Affairs Office (SCRFA) statewide all payer claims database including 2,476,431 hospitalizations in SC acute care hospitals between 2008 and 2014. STUDY DESIGN: We compared the odds of unplanned all-cause 30-day readmission for private insurance, Medicare, Medicaid, uninsured, and other payers and examined interaction effects between payer and index admission characteristics using generalized estimating equations. DATA COLLECTION: SCRFA receives claims and administrative health care data from all SC health care facilities in accordance with SC state law. PRINCIPAL FINDINGS: Odds of readmission were lower for females compared to males in private, Medicare, and Medicaid payers. African Americans had higher odds of readmission compared to whites across private insurance, Medicare, and Medicaid, but they had lower odds among the uninsured. Longer length of stay had the strongest association with readmission for private and other payers, whereas an increased number of comorbidities related to the highest readmission odds within Medicaid. CONCLUSIONS: Associations between index admission characteristics and readmission likelihood varied significantly with payer. Findings should guide the development of payer-specific quality improvement programs.

Priming professionals for a complex communication environment: Findings from a pilot study.

Factors such as time pressure, distractions, and profession-specific jargon can contribute to poor communication in complex working environments such as healthcare. Technical solutions are often sought to improve patient care when simple improvements in communication would suffice. This article describes an icebreaker activity, an interprofessional game, aimed to prime and engage experienced healthcare professionals on the topic of communication, specifically related to care transitions. By using unexpected content from veterinary care, cycling messages rapidly, and by adding distractors, we were successful in creating openness to considering communication needs in new ways. Participants completed an evaluation following this intervention. It was found that the activity was effective at raising awareness of communication problems and the activity caused participants to view care transitions communications in new ways. In particular, it was reported that this activity illustrated opportunities for communication improvement at multiple levels including peer-to-peer and with patients. This interprofessional activity can illustrate communication barriers, both within and beyond healthcare, in an interactive and engaging manner.

IRB reliance: An informatics approach.

Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules.

BACKGROUND AND OBJECTIVES: Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone. METHODS: Randomized, multicenter, open-label study. Healthy infants (6-14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups. RESULTS: Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated. CONCLUSIONS: Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone.

Leveraging a Statewide Clinical Data Warehouse to Expand Boundaries of the Learning Health System.

Learning Health Systems (LHS) require accessible, usable health data and a culture of collaboration-a challenge for any single system, let alone disparate organizations, with macro- and micro-systems. Recently, the National Science Foundation described this important setting as a cyber-social ecosystem. In 2004, in an effort to create a platform for transforming health in South Carolina, Health Sciences South Carolina (HSSC) was established as a research collaboration of the largest health systems, academic medical centers and research intensive universities in South Carolina. With work beginning in 2010, HSSC unveiled an integrated Clinical Data Warehouse (CDW) in 2013 as a crucial anchor to a statewide LHS. This CDW integrates data from independent health systems in near-real time, and harmonizes the data for aggregation and use in research. With records from over 2.7 million unique patients spanning 9 years, this multi-institutional statewide clinical research repository allows integrated individualized patient-level data to be used for multiple population health and biomedical research purposes. In the first 21 months of operation, more than 2,800 de-identified queries occurred through i2b2, with 116 users. HSSC has developed and implemented solutions to complex issues emphasizing anti-competitiveness and participatory governance, and serves as a recognized model to organizations working to improve healthcare quality by extending the traditional borders of learning health systems.

Safety and efficacy of a cytomegalovirus glycoprotein B (gB) vaccine in adolescent girls: A randomized clinical trial.

BACKGROUND: Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development. METHODS: CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens. RESULTS: 402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400 EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: -36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: -9; 72, p=0.08. CONCLUSION: The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.

Evolution and Initial Experience of a Statewide Care Transitions Quality Improvement Collaborative: Preventing Avoidable Readmissions Together.

Increasing scrutiny of hospital readmission rates has spurred a wide variety of quality improvement initiatives. The Preventing Avoidable Readmissions Together (PART) initiative is a statewide quality improvement learning collaborative organized by stakeholder organizations in South Carolina. This descriptive report focused on initial interventions with hospitals. Eligible participants included all acute care hospitals plus home health organizations, nursing facilities, hospices, and other health care organizations. Measures were degree of statewide participation, curricular engagement, adoption of evidence-based improvement strategies, and readmission rate changes. Fifty-nine of 64 (92%) acute care hospitals and 9 of 10 (90%) hospital systems participated in collaborative events. Curricular engagement included: webinars and coaching calls (49/59, 83%), statewide in-person meetings (35/59, 59%), regional in-person meetings (44/59, 75%), and individualized consultations (46/59, 78%). Among 34 (58%) participating hospitals completing a survey at the completion of Year 1, respondents indicated complete implementation of multidisciplinary rounding (58%), post-discharge telephone calls (58%), and teach-back (32%), and implementation in process of high-quality transition records (52%), improved discharge summaries (45%), and timely follow-up appointments (39%). A higher proportion of hospitals had significant decreases (≥10% relative change) in all-cause readmission rates for acute myocardial infarction (55.6% vs. 30.4%, P=0.01), heart failure (54.2% vs. 31.7%, P=0.09), and chronic obstructive pulmonary disease (41.7% vs. 33.3%, P=0.83) between 2011-2013 compared to earlier (2009-2011) trends. Focus on reducing readmissions is driving numerous, sometimes competing, quality improvement initiatives. PART successfully engaged the majority of acute care facilities in one state to harmonize and accelerate adoption of evidence-based care transitions strategies.