Enhancing the implementation of provider-to-provider telehealth in rural and remote areas: A mixed methods study protocol.

Background: Virtual healthcare solutions are proposed as a way to combat the inequity of access to healthcare in rural and remote areas, and to better support the front-line providers who work in these areas. Rural provider-to-provider telehealth (RPPT) connects rural and remote clinicians to a 'hub' of healthcare specialists who can increase access to emergency and specialised healthcare via an integrated model. Reported benefits for the place-based provider include enhanced knowledge, expanded professional development opportunities, improved scope of practice, and increased confidence in treating more complex cases. These reported benefits could have implications for supporting and futureproofing our health workforce in terms of productivity, burnout, recruitment, and retention. Methods: The research uses an explanatory sequential mixed methods approach across multiple phases to evaluate the current implementation of Western Australia Country Health Service's (WACHS) Command Centre (CC) services and explore factors associated with their differential use. The primary population of interest and participants in this study are the place-based providers in country Western Australia (WA). Patient data constitutes the secondary population, informing the access and reach of CC services into country WA. Data collection will include service data, an online survey, and semi-structured interviews with the primary population. The data will be interpreted to inform evidence-based strategies and recommendations to improve the implementation and sustainment of RPPT. Discussion: Innovative and sustained workforce models and solutions are needed globally. Virtual healthcare, including provider-to-provider models, demonstrate potential, especially in rural and remote areas, designed to increase access to specialised expertise for patients and to support the local workforce. This research will generate new data around behaviour, perceptions, and value from the WACHS rural and remote workforce about provider-to-provider telehealth, to explore the implementation and investigate strategies for the long-term sustainment of RPPT services.

[Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach : German version]. / Evidenzbasierte Interventionen zur Behandlung von chronischem Schmerz im unteren Rücken ­ Therapieauswahl für einen personalisierten Behandlungsansatz : Deutsche Fassung.

INTRODUCTION: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. OBJECTIVE: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. METHODS: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. CONCLUSION: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

Suicide Mortality Among Formerly Incarcerated People Compared With the General Population in North Carolina, 2000-2020.

We aimed to compare rates and characteristics of suicide mortality in formerly incarcerated people with those of the general population in North Carolina. We conducted a retrospective cohort study of 266,400 people released from North Carolina state prisons between January 1, 2000, and March 1, 2020. Using direct and indirect standardization by age, sex, and calendar year, we calculated standardized suicide mortality rates and standardized mortality ratios comparing formerly incarcerated people with the North Carolina general population. We evaluated effect modification by race/ethnicity, sex, age, and firearm involvement. Formerly incarcerated people had approximately twice the overall suicide mortality of the general population for 3 years after release, with the highest rate of suicide mortality being observed in the 2-week period after release. In contrast to patterns in the general population, formerly incarcerated people had higher rates of non-firearm-involved suicide mortality than firearm-involved suicide mortality. Formerly incarcerated female, White and Hispanic/Latino, and emerging adult people had a greater elevation of suicide mortality than their general-population peers compared with other groups. These findings suggest a need for long-term support for formerly incarcerated people as they return to community living and a need to identify opportunities for interventions that reduce the harms of incarceration for especially vulnerable groups. This article is part of a Special Collection on Mental Health.

Meet us where we are: non-Indigenous young peoples' ideas on how to reduce alcohol-related harm in Mparntwe (Alice Springs).

OBJECTIVE: This research sought to understand the strategies young people in a remote central Australian town believed would reduce alcohol-related harms amongst their peers. METHODS: A total of 38 non-Indigenous residents of Mparntwe (Alice Springs), aged between 14 and 18 years, participated in focus groups at their school. Participants discussed strategies they thought would reduce alcohol-related harms among people their age. Data were analysed using thematic analysis. RESULTS: Participants suggested that young peoples' drinking behaviour developed with peers. Through social learning in peer groups, drinking alcohol was perceived as fun and normal. Participants indicated a willingness to learn about strategies to stay safe around alcohol. Their ideas for doing so reflected their existing social methods of learning about alcohol: having comfortable conversations and storytelling with a small group of peers and a relatable role model. CONCLUSIONS: Young residents of Mparntwe (Alice Springs) advised that alcohol-related harm reduction strategies would be most effective if focussed on safety, rather than abstinence, and applied social-learning strategies. IMPLICATIONS FOR PUBLIC HEALTH: Young people value their burgeoning self-determination. Youth health interventions must engage youth in intervention co-design and aim to assist young people to make safer decisions, rather than making decisions on their behalf.

Ethnoracial Differences in Premenopausal Hysterectomy: The Role of Symptom Severity.

OBJECTIVE: To evaluate whether greater symptom severity can explain higher hysterectomy rates among premenopausal non-Hispanic Black compared with White patients in the U.S. South rather than potential overtreatment of Black patients. METHODS: Using electronic health record data from 1,703 patients who underwent hysterectomy in a large health care system in the U.S. South between 2014 and 2017, we assessed symptom severity to account for differences in hysterectomy rates for noncancerous conditions among premenopausal non-Hispanic Black, non-Hispanic White, and Hispanic patients. We used Poisson generalized linear mixed modeling to estimate symptom severity (greater than the 75th percentile on composite symptom severity scores of bleeding, bulk, or pelvic pain) as a function of race-ethnicity. We calculated prevalence ratios (PRs). We controlled for factors both contra-indicating and contributing to hysterectomy. RESULTS: The overall median age of non-Hispanic White (n=1,050), non-Hispanic Black (n=565), and Hispanic (n=158) patients was 40 years. The White and Black patients were mostly insured (insured greater than 95%), whereas the Hispanic patients were often uninsured (insured 58.9%). White and Black patients were mostly treated outside academic medical centers (nonmedical center: 63.7% and 58.4%, respectively); the opposite was true for Hispanic patients (nonmedical center: 34.2%). Black patients had higher bleeding severity scores compared with Hispanic and White patients (median 8, 7, and 4 respectively) and higher bulk scores (median 3, 1, and 0, respectively), but pain scores differed (median 3, 5, and 4, respectively). Black and Hispanic patients were disproportionately likely to have severe symptoms documented on two or more symptoms (referent: not severe on any symptoms) (adjusted PR [Black vs White] 3.02, 95% CI 2.29-3.99; adjusted PR [Hispanic vs White] 2.61, 95% CI 1.78-3.83). Although Black and Hispanic patients were more likely to experience severe symptoms, we found no racial and ethnic differences in the number of alternative treatments attempted before hysterectomy. CONCLUSION: We did not find evidence of overtreatment of Black patients. Our findings suggest potential undertreatment of Black and Hispanic patients with uterine-sparing alternatives earlier in their disease progression.

Effectiveness of strategies to reduce risky alcohol consumption among youth living in rural or remote areas: a systematic review.

OBJECTIVE: This review aimed to evaluate the effectiveness of strategies to reduce risky alcohol consumption among youth living in rural and remote areas. INTRODUCTION: Youth living in rural and remote areas are more likely to drink alcohol and experience alcohol-related harm than youth living in urban locations. This review assessed the effectiveness of strategies to reduce young people's risky alcohol consumption in rural and remote areas. INCLUSION CRITERIA: We considered papers that included youth (aged 12 to 24 years; also referred to in this review as young people ) who were identified as living in rural or remote locations. Any intervention or strategy designed to reduce or prevent alcohol consumption among this population was included. The primary outcome was frequency of short-term risky alcohol consumption as measured by self-reported incidents of drinking 5 or more standard drinks in 1 session. METHODS: We conducted this systematic review in accordance with the JBI methodology for systematic reviews of effectiveness. We searched for published and unpublished English-language studies and gray literature from 1999 to December 2021. Two authors screened titles and abstracts before full-text screening and data extraction. Two authors reviewed the extracted data to identify studies that reported duplicate data (eg, due to progressive publication of longitudinal data sets) and, where multiple studies reported the same data set, the study with the measure most proximal to the primary outcome measure and/or with the longest follow-up was selected. Two authors then critically appraised the studies. There were no interventions that were assessed for impact on the primary outcome in more than 1 study; in turn, the feasibility and utility of statistical pooling and the Summary of Findings were limited. Instead, results and certainty of evidence is provided in narrative format. RESULTS: Twenty-eight articles reporting on 16 studies were included in the review: 10 randomized controlled trials, 4 quasi-experimental studies, and 2 cohort studies. All studies except 1 were conducted in the United States. Only 3 studies measured the primary outcome of short-term risky alcohol consumption and included a comparison group. A meta-analysis of 2 of these studies showed that interventions that included motivational interviewing had a small and non-significant effect on short-term risky alcohol consumption among Indigenous youth in the United States. Meta-analyses of the effect of a variety of interventions on secondary outcomes demonstrated that intervention was not more effective than control for reducing past month drunkenness; however, intervention was more effective for reducing past month alcohol use (odds radio 0.3; 95% CI 0.13 to 0.67; P =0.003). The heterogeneity of effects was evident within these meta-analyses as well as in the studies unable to be meta-analyzed. CONCLUSION: Based on this review, no interventions can be broadly recommended for reducing short-term risky alcohol consumption among youth in rural and remote areas. Further research to increase the robustness of available evidence in relation to the effectiveness of strategies to reduce short-term risky alcohol consumption among youth in rural and remote areas is urgently required. REVIEW REGISTRATION: PROSPERO CRD42020167834.

The Ubiquitin-specific Protease USP36 Associates with the Microprocessor Complex and Regulates miRNA Biogenesis by SUMOylating DGCR8.

miRNA biogenesis is a cellular process that produces mature miRNAs from their primary transcripts, pri-miRNAs, via two RNAse III enzyme complexes: the Drosha-DGCR8 microprocessor complex in the nucleus and the Dicer-TRBP complex in the cytoplasm. Emerging evidence suggests that miRNA biogenesis is tightly regulated by posttranscriptional and posttranslational modifications and aberrant miRNA biogenesis is associated with various human diseases including cancer. DGCR8 has been shown to be modified by SUMOylation. Yet, the SUMO ligase mediating DGCR8 SUMOylation is currently unknown. Here, we report that USP36, a nucleolar ubiquitin-specific protease essential for ribosome biogenesis, is a novel regulator of DGCR8. USP36 interacts with the microprocessor complex and promotes DGCR8 SUMOylation, specifically modified by SUMO2. USP36-mediated SUMOylation does not affect the levels of DGCR8 and the formation of the Drosha-DGCR8 complex, but promotes the binding of DGCR8 to pri-miRNAs. Consistently, abolishing DGCR8 SUMOylation significantly attenuates its binding to pri-miRNAs and knockdown of USP36 attenuates pri-miRNA processing, resulting in marked reduction of tested mature miRNAs. Induced expression of a SUMOylation-defective mutant of DGCR8 inhibits cell proliferation. Together, these results suggest that USP36 plays an important role in regulating miRNA biogenesis by SUMOylating DGCR8. Significance: This study identifies that USP36 mediates DGCR8 SUMOylation by SUMO2 and is critical for miRNA biogenesis. As USP36 is frequently overexpressed in various human cancers, our study suggests that deregulated USP36-miRNA biogenesis pathway may contribute to tumorigenesis.

Hurricane Florence and suicide mortality in North Carolina: a controlled interrupted time-series analysis.

BACKGROUND: Natural disasters are associated with increased mental health disorders and suicidal ideation; however, associations with suicide deaths are not well understood. We explored how Hurricane Florence, which made landfall in September 2018, may have impacted suicide deaths in North Carolina (NC). METHODS: We used publicly available NC death records data to estimate associations between Hurricane Florence and monthly suicide death rates using a controlled, interrupted time series analysis. Hurricane exposure was determined by using county-level support designations from the Federal Emergency Management Agency. We examined effect modification by sex, age group, and race/ethnicity. RESULTS: 8363 suicide deaths occurred between January 2014 and December 2019. The overall suicide death rate in NC between 2014 and 2019 was 15.53 per 100 000 person-years (95% CI 15.20 to 15.87). Post-Hurricane, there was a small, immediate increase in the suicide death rate among exposed counties (0.89/100 000 PY; 95% CI -2.69 to 4.48). Comparing exposed and unexposed counties, there was no sustained post-Hurricane Florence change in suicide death rate trends (0.02/100 000 PY per month; 95% CI -0.33 to 0.38). Relative to 2018, NC experienced a statewide decline in suicides in 2019. An immediate increase in suicide deaths in Hurricane-affected counties versus Hurricane-unaffected counties was observed among women, people under age 65 and non-Hispanic black individuals, but there was no sustained change in the months after Hurricane Florence. CONCLUSIONS: Although results did not indicate a strong post-Hurricane Florence impact on suicide rates, subgroup analysis suggests differential impacts of Hurricane Florence on several groups, warranting future follow-up.

The Back Pain Consortium (BACPAC) Research Program: Structure, Research Priorities, and Methods.

In 2019, the National Health Interview survey found that nearly 59% of adults reported pain some, most, or every day in the past 3 months, with 39% reporting back pain, making back pain the most prevalent source of pain, and a significant issue among adults. Often, identifying a direct, treatable cause for back pain is challenging, especially as it is often attributed to complex, multifaceted issues involving biological, psychological, and social components. Due to the difficulty in treating the true cause of chronic low back pain (cLBP), an over-reliance on opioid pain medications among cLBP patients has developed, which is associated with increased prevalence of opioid use disorder and increased risk of death. To combat the rise of opioid-related deaths, the National Institutes of Health (NIH) initiated the Helping to End Addiction Long-TermSM (HEAL) initiative, whose goal is to address the causes and treatment of opioid use disorder while also seeking to better understand, diagnose, and treat chronic pain. The NIH Back Pain Consortium (BACPAC) Research Program, a network of 14 funded entities, was launched as a part of the HEAL initiative to help address limitations surrounding the diagnosis and treatment of cLBP. This paper provides an overview of the BACPAC research program's goals and overall structure, and describes the harmonization efforts across the consortium, define its research agenda, and develop a collaborative project which utilizes the strengths of the network. The purpose of this paper is to serve as a blueprint for other consortia tasked with the advancement of pain related science.

Development and validation of an electronic health records-based opioid use disorder algorithm by expert clinical adjudication among patients with prescribed opioids.

BACKGROUND: In the US, over 200 lives are lost from opioid overdoses each day. Accurate and prompt diagnosis of opioid use disorders (OUD) may help prevent overdose deaths. However, international classification of disease (ICD) codes for OUD are known to underestimate prevalence, and their specificity and sensitivity are unknown. We developed and validated algorithms to identify OUD in electronic health records (EHR) and examined the validity of OUD ICD codes. METHODS: Through four iterations, we developed EHR-based OUD identification algorithms among patients who were prescribed opioids from 2014 to 2017. The algorithms and OUD ICD codes were validated against 169 independent "gold standard" EHR chart reviews conducted by an expert adjudication panel across four healthcare systems. After using 2014-2020 EHR for validating iteration 1, the experts were advised to use 2014-2017 EHR thereafter. RESULTS: Of the 169 EHR charts, 81 (48%) were reviewed by more than one expert and exhibited 85% expert agreement. The experts identified 54 OUD cases. The experts endorsed all 11 OUD criteria from the Diagnostic and Statistical Manual of Mental Disorders-5, including craving (72%), tolerance (65%), withdrawal (56%), and recurrent use in physically hazardous conditions (50%). The OUD ICD codes had 10% sensitivity and 99% specificity, underscoring large underestimation. In comparison our algorithm identified OUD with 23% sensitivity and 98% specificity. CONCLUSIONS AND RELEVANCE: This is the first study to estimate the validity of OUD ICD codes and develop validated EHR-based OUD identification algorithms. This work will inform future research on early intervention and prevention of OUD.

Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach.

Introduction: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. Objective: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. Methods: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. Conclusion: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

Association between alcohol restriction policies and rates of alcohol-related harms in remote Australian Aboriginal and Torres Strait Islander communities: a systematic review.

OBJECTIVE: The objective of this review was to examine the association between alcohol supply restriction policies and rates of alcohol-related harms in remote Australian Aboriginal and Torres Strait Islander communities. INTRODUCTION: Aboriginal and Torres Strait Islander peoples living in remote communities experience a higher rate of alcohol-related harms than other Australians. High rates of alcohol consumption are associated with a range of physical and social harms. Restricting the supply of alcoholic beverages in Aboriginal and Torres Strait Islander communities is often used by governments as a strategy to reduce these harms, but the current evidence is conflicting. INCLUSION CRITERIA: This review considered all quantitative studies with Aboriginal and Torres Strait Islander participants living in remote communities in Australia, where the participants were exposed to restrictions on the supply of alcoholic beverages. Harms of interest were i) physical injuries (whether secondary to assaults or accidents), measured as hospital admissions, Royal Flying Doctor Service attendance and transfers, and reported assaults, including intimate partner or family violence; ii) alcohol-related illnesses, measured as hospital admissions for conditions primarily attributed to alcohol consumption; and iii) rates of alcohol consumption, measured as alcohol sales per person or as self-reported consumption. METHODS: We searched a wide range of databases and gray literature resources for published and unpublished, English-language studies from 1998 to 2020. Two reviewers independently screened search results and selected citations for full-text retrieval. Two reviewers independently assessed each article for congruence to the inclusion criteria. Critical appraisal and data extraction were conducted by two reviewers working independently. Data were narratively synthesized because statistical pooling was not possible. RESULTS: We included 13 observational studies with more than 15,800 participants. Most included studies reported some harm reductions in association with a variety of alcohol supply restrictions; however, these reductions were sometimes short-lived. Studies reported on a variety of supply reduction strategies, ranging from small limitations on when alcohol could be sold to total prohibition of alcohol within the community. None of the interventions examined in the included studies reported consistent results. Total prohibition of alcohol was initially associated with large reductions in consumption but also led to unintended consequences, such as illicit substance use, alcohol consumption outside of the community, and illegal importation of alcohol into the community. We were unable to make any strong recommendations based on the included studies due to inherent bias in the study designs employed. CONCLUSIONS: Problematic use of alcohol by Aboriginal and Torres Strait Islander peoples is unlikely to be solved by a single strategy. Total alcohol prohibition does not stop people from seeking and accessing alcohol, and may in fact lead to a range of negative unintended consequences. Future studies should be more rigorously designed and reported to increase the strength of the evidence and certainty in the results.

Feasibility of a best-worst scaling exercise to set priorities for autism research.

BACKGROUND: The preferences of autism stakeholders regarding the top priorities for future autism research are largely unknown. OBJECTIVE: This study had two objectives: First, to examine what autism stakeholders think new research investments should be and the attributes of investment that they consider important, and second, to explore the feasibility, acceptability and outcomes of two prioritization exercises among autism stakeholders regarding their priorities for future research in autism. DESIGN: This was  a prospective stakeholder-engaged iterative study consisting of best-worst scaling (BWS) and direct prioritization exercise. SETTING AND PARTICIPANTS: A national snowball sample of 219 stakeholders was included: adults with autism, caregivers, service providers and researchers. MAIN OUTCOME MEASURES: The main outcomes measures were attributes that participants value in future research investments, and priority research investments for future research. RESULTS: Two hundred and nineteen participants completed the exercises, of whom 11% were adults with autism, 58% were parents/family members, 37% were service providers and 21% were researchers. Among stakeholders, the BWS exercises were easier to understand than the direct prioritization, less frequently skipped and yielded more consistent results. The proportion of children with autism affected by the research was the most important attribute for all types of stakeholders. The top three priorities among future research investments were (1) evidence on which child, family and intervention characteristics lead to the best/worst outcomes; (2) evidence on how changes in one area of a child's life are related to changes in other areas; and (3) evidence on dietary interventions. Priorities were similar for all stakeholder types. CONCLUSIONS: The values and priorities examined here provide a road map for investigators and funders to pursue autism research that matters to stakeholders. PATIENT OR PUBLIC CONTRIBUTION: Stakeholders completed a BWS and direct prioritization exercise to inform us about their priorities for future autism research.

Innovations in suicide prevention research (INSPIRE): a protocol for a population-based case-control study.

BACKGROUND: Suicide deaths have been increasing for the past 20 years in the USA resulting in 45 979 deaths in 2020, a 29% increase since 1999. Lack of data linkage between entities with potential to implement large suicide prevention initiatives (health insurers, health institutions and corrections) is a barrier to developing an integrated framework for suicide prevention. OBJECTIVES: Data linkage between death records and several large administrative datasets to (1) estimate associations between risk factors and suicide outcomes, (2) develop predictive algorithms and (3) establish long-term data linkage workflow to ensure ongoing suicide surveillance. METHODS: We will combine six data sources from North Carolina, the 10th most populous state in the USA, from 2006 onward, including death certificate records, violent deaths reporting system, large private health insurance claims data, Medicaid claims data, University of North Carolina electronic health records and data on justice involved individuals released from incarceration. We will determine the incidence of death from suicide, suicide attempts and ideation in the four subpopulations to establish benchmarks. We will use a nested case-control design with incidence density-matched population-based controls to (1) identify short-term and long-term risk factors associated with suicide attempts and mortality and (2) develop machine learning-based predictive algorithms to identify individuals at risk of suicide deaths. DISCUSSION: We will address gaps from prior studies by establishing an in-depth linked suicide surveillance system integrating multiple large, comprehensive databases that permit establishment of benchmarks, identification of predictors, evaluation of prevention efforts and establishment of long-term surveillance workflow protocols.

Linking Electronic Health Records to the American Community Survey: Feasibility and Process.

Objectives. To assess linkages of patient data from a health care system in the southeastern United States to microdata from the American Community Survey (ACS) with the goal of better understanding health disparities and social determinants of health in the population. Methods. Once a data use agreement was in place, a stratified random sample of approximately 200 000 was drawn of patients aged 25 to 74 years with at least 2 visits between January 1, 2016, and December 31, 2019. Information from the sampled electronic health records (EHRs) was transferred securely to the Census Bureau, put through the Census Person Identification Validation System to assign Protected Identification Keys (PIKs) as unique identifiers wherever possible. EHRs with PIKs assigned were then linked to 2001-2017 ACS records with a PIK. Results. PIKs were assigned to 94% of the sampled patients. Of patients with PIKs, 15.5% matched to persons sampled in the ACS. Conclusions. Linking data from EHRs to ACS records is feasible and, with adjustments for differential coverage, will advance understanding of social determinants and enhance the ability of integrated delivery systems to reflect and affect the health of the populations served. (Am J Public Health. 2022;112(6):923-930. https://doi.org/10.2105/AJPH.2022.306783).

Boosting of SARS-CoV-2 immunity in nonhuman primates using an oral rhabdoviral vaccine.

An orally active vaccine capable of boosting SARS-CoV-2 immune responses in previously infected or vaccinated individuals would help efforts to achieve and sustain herd immunity. Unlike mRNA-loaded lipid nanoparticles and recombinant replication-defective adenoviruses, replicating vesicular stomatitis viruses with SARS-CoV-2 spike glycoproteins (VSV-SARS2) were poorly immunogenic after intramuscular administration in clinical trials. Here, by G protein trans-complementation, we generated VSV-SARS2(+G) virions with expanded target cell tropism. Compared to parental VSV-SARS2, G-supplemented viruses were orally active in virus-naive and vaccine-primed cynomolgus macaques, powerfully boosting SARS-CoV-2 neutralizing antibody titers. Clinical testing of this oral VSV-SARS2(+G) vaccine is planned.

Supporting research, protecting data: one institution's approach to clinical data warehouse governance.

Institutions must decide how to manage the use of clinical data to support research while ensuring appropriate protections are in place. Questions about data use and sharing often go beyond what the Health Insurance Portability and Accountability Act of 1996 (HIPAA) considers. In this article, we describe our institution's governance model and approach. Common questions we consider include (1) Is a request limited to the minimum data necessary to carry the research forward? (2) What plans are there for sharing data externally?, and (3) What impact will the proposed use of data have on patients and the institution? In 2020, 302 of the 319 requests reviewed were approved. The majority of requests were approved in less than 2 weeks, with few or no stipulations. For the remaining requests, the governance committee works with researchers to find solutions to meet their needs while also addressing our collective goal of protecting patients.

Rigid intramedullary nail fixation of traumatic femoral fractures in the skeletally immature.

OBJECTIVE: To determine the rate of femoral head osteonecrosis, and other complications following rigid intramedullary (IM) nail fixation of traumatic diaphyseal femur fractures through the greater trochanter in the skeletally immature. DESIGN: Retrospective review, case series. SETTING: Level I academic trauma center. PATIENTS/PARTICIPANTS: One hundred forty-eight traumatic pediatric diaphyseal femur fractures in 145 patients treated with rigid IM nail fixation from November 1, 2004 to December 31, 2018. INTERVENTION: Rigid intramedullary nail fixation of traumatic diaphyseal femur fractures through a trochanteric start point in the skeletally immature. MAIN OUTCOME MEASUREMENT: Rate of osteonecrosis of the femoral head. RESULTS: Sixty-five fractures in 64 skeletally immature patients met inclusion criteria. Motor vehicle collisions were implicated in 32 fractures. Of the 65 fractures, 5 were open. All rigid IM nails were anterograde with a trochanteric start point. Mean radiographic follow-up was 27.4 ±â€Š8.1 months. Twenty-two patients experienced postoperative pain and/or hardware irritation, with 24 patients (36.9%) undergoing reoperation for hardware removal. No occurrences of infection, malunion, nonunion, refracture, venous thromboembolism, fat embolism, significant leg length discrepancy, or femoral head osteonecrosis were documented. Two cases of heterotopic ossification were observed, 1 requiring surgical excision, yielding a complication rate of 3.1%. CONCLUSIONS: No cases of femoral head osteonecrosis were observed following treatment of 65 traumatic diaphyseal femur fractures with rigid IM nailing through the greater trochanter with a mean radiographic follow-up of 27 months. Rigid IM nail fixation with a trochanteric start point is both safe and efficacious for management of diaphyseal femur fractures in the skeletally immature.