Search

Introduction: The burden of mental health-related visits to emergency departments (EDs) is growing, and agitation episodes are prevalent with such visits. Best practice guidance from experts recommends early assessment of at-risk populations and pre-emptive intervention using de-escalation techniques to prevent agitation. Time pressure, fluctuating work demands, and other systems-related factors pose challenges to efficient decision-making and adoption of best practice recommendations during an unfolding behavioural crisis. As such, we propose to design, develop and evaluate a computerised clinical decision support (CDS) system, Early Detection and Treatment to Reduce Events with Agitation Tool (ED-TREAT). We aim to identify patients at risk of agitation and guide ED clinicians through appropriate risk assessment and timely interventions to prevent agitation with a goal of minimising restraint use and improving patient experience and outcomes., Methods and Analysis: This study describes the formative evaluation of the health record embedded CDS tool. Under aim 1, the study will collect qualitative data to design and develop ED-TREAT using a contextual design approach and an iterative user-centred design process. Participants will include potential CDS users, that is, ED physicians, nurses, technicians, as well as patients with lived experience of restraint use for behavioural crisis management during an ED visit. We will use purposive sampling to ensure the full spectrum of perspectives until we reach thematic saturation. Next, under aim 2, the study will conduct a pilot, randomised controlled trial of ED-TREAT at two adult ED sites in a regional health system in the Northeast USA to evaluate the feasibility, fidelity and bedside acceptability of ED-TREAT. We aim to recruit a total of at least 26 eligible subjects under the pilot trial., Ethics and Dissemination: Ethical approval by the Yale University Human Investigation Committee was obtained in 2021 (HIC# 2000030893 and 2000030906). All participants will provide informed verbal consent prior to being enrolled in the study. Results will be disseminated through publications in open-access, peer-reviewed journals, via scientific presentations or through direct email notifications., Trial Registration Number: NCT04959279; Pre-results., Competing Interests: Competing interests: AHW reported receiving grants from National Institute of Health outside the conduct of the study. ERM reported receiving grants and contracts from the National Institute of Health, Agency for Healthcare Research and Quality, American Medical Association, and Centers for Medicare & Medicaid Services outside of this study. TM reported receiving grants from the National Institute of Health, Agency for Healthcare Research and Quality, and Google outside of this study. TM is a member of the Clinical Diversity Advisory Board at Woebot Health and Advisory Board at RACE Space. RH reported receiving salary support from the Centers for Medicare & Medicaid Services to develop, implement, and maintain clinical performance outcome measures that are publicly reported, in addition to receiving research support from the US Food and Drug Administration, Centers for Disease Control and Prevention, National Institute of Health, Connecticut Department of Public Health, and from the Community Health Network of Connecticut for her work as a medical consultant. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Opioid overdose deaths have disproportionately impacted Black and Hispanic populations, in part due to disparities in treatment access. Emergency departments (EDs) serve as a resource for patients with opioid use disorder (OUD), many of whom have difficulty accessing outpatient addiction programs. However, inequities in ED treatment for OUD remain poorly understood., Methods: This secondary analysis examined racial and ethnic differences in buprenorphine access using data from EMBED, a study of 21 EDs across five health care systems evaluating a clinical decision support system for initiating ED buprenorphine. The primary outcome was receipt of buprenorphine, ED administered or prescribed. Hospital type (academic vs. community) was evaluated as an effect modifier. Hierarchical models with cluster effects for site and clinician were used to assess buprenorphine receipt by race and ethnicity., Results: Black patients were less likely to receive buprenorphine (6.4% [51/801] vs. White patients 8.5% [268/3154], odds ratio [OR] 0.59, 95% confidence interval [CI] 0.45-0.78). This association persisted after adjusting for age, insurance, gender, clinician X-waiver, hospital type, and urbanicity (adjusted OR [aOR] 0.64, 95% CI 0.48-0.84) but not when discharge diagnosis was included (aOR 0.75, 95% CI 0.56-1.02). Hispanic patients were more likely to receive buprenorphine (14.8% [122/822] vs. non-Hispanic patients, 11.6% [475/4098]) in unadjusted (OR 1.57, 95% CI 1.09-1.83) and adjusted models (aOR 1.41, 95% CI 1.08-1.83) but not including discharge diagnosis (aOR 1.32, 95% CI 0.99-1.77). Odds of buprenorphine were similar in academic and community EDs by race (interaction p = 0.97) and ethnicity (interaction p = 0.64)., Conclusions: Black patients with OUD were less likely to receive buprenorphine whereas Hispanic patients were more likely to receive buprenorphine in academic and community EDs. Differences were attenuated with discharge diagnosis, as fewer Black and non-Hispanic patients were diagnosed with opioid withdrawal. Barriers to medication treatment are heterogenous among patients with OUD; research must continue to address the multiple drivers of health inequities at the patient, clinician, and community level., (© 2023 The Authors. Academic Emergency Medicine published by Wiley Periodicals LLC on behalf of Society for Academic Emergency Medicine.)

Importance: Previous studies have demonstrated racial and ethnic inequities in medical student assessments, awards, and faculty promotions at academic medical centers. Few data exist about similar racial and ethnic disparities at the level of graduate medical education., Objective: To examine the association between race and ethnicity and performance assessments among a national cohort of internal medicine residents., Design, Setting, and Participants: This retrospective cohort study evaluated assessments of performance for 9026 internal medicine residents from the graduating classes of 2016 and 2017 at Accreditation Council of Graduate Medical Education (ACGME)-accredited internal medicine residency programs in the US. Analyses were conducted between July 1, 2020, and June 31, 2022., Main Outcomes and Measures: The primary outcome was midyear and year-end total ACGME Milestone scores for underrepresented in medicine (URiM [Hispanic only; non-Hispanic American Indian, Alaska Native, or Native Hawaiian/Pacific Islander only; or non-Hispanic Black/African American]) and Asian residents compared with White residents as determined by their Clinical Competency Committees and residency program directors. Differences in scores between Asian and URiM residents compared with White residents were also compared for each of the 6 competency domains as supportive outcomes., Results: The study cohort included 9026 residents from 305 internal medicine residency programs. Of these residents, 3994 (44.2%) were female, 3258 (36.1%) were Asian, 1216 (13.5%) were URiM, and 4552 (50.4%) were White. In the fully adjusted model, no difference was found in the initial midyear total Milestone scores between URiM and White residents, but there was a difference between Asian and White residents, which favored White residents (mean [SD] difference in scores for Asian residents: -1.27 [0.38]; P < .001). In the second year of training, White residents received increasingly higher scores relative to URiM and Asian residents. These racial disparities peaked in postgraduate year (PGY) 2 (mean [SD] difference in scores for URiM residents, -2.54 [0.38]; P < .001; mean [SD] difference in scores for Asian residents, -1.9 [0.27]; P < .001). By the final year 3 assessment, the gap between White and Asian and URiM residents' scores narrowed, and no racial or ethnic differences were found. Trends in racial and ethnic differences among the 6 competency domains mirrored total Milestone scores, with differences peaking in PGY2 and then decreasing in PGY3 such that parity in assessment was reached in all competency domains by the end of training., Conclusions and Relevance: In this cohort study, URiM and Asian internal medicine residents received lower ratings on performance assessments than their White peers during the first and second years of training, which may reflect racial bias in assessment. This disparity in assessment may limit opportunities for physicians from minoritized racial and ethnic groups and hinder physician workforce diversity.

Introduction: COVID-19 required healthcare systems to iteratively adapt for safe and up-to-date care as knowledge of the disease rapidly evolved. Rates of COVID-19 infections continue to fluctuate and patients without COVID-19 increasingly return to the emergency department (ED) for care. This leads to new challenges and threats to patient and clinician safety as suspected patients with COVID-19 need to be quickly detected and isolated among other patients with non-COVID-19-related illnesses. At the front lines, emergency physicians also face continued personal safety concerns and increased work burden, which heighten stress and anxiety, especially given the prolonged course of the pandemic. Burnout, already a serious concern for emergency physicians due to the cumulative stresses of their daily practice, may present as a longer-term outcome of these acute stressors., Methods and Analysis: We will implement a rapidly adaptive simulation-based approach to understand and improve physician preparedness while decreasing physician stress and anxiety. First, we will conduct semi-structured qualitative interviews and human factor observations to determine the challenges and facilitators of COVID-19 preparedness and mitigation of physician stress. Next, we will conduct a randomised controlled trial to test the effectiveness of a simulation preparedness intervention on physician physiological stress as measured by decreased heart rate variability on shift and anxiety as measured by the State-Trait Anxiety Inventory., Ethics and Dissemination: The protocol was reviewed and approved by the Agency for Healthcare Research and Quality for funding, and ethics approval was obtained from the Yale University Human Investigation Committee in 2020 (HIC# 2000029370 and 2000029372). To support ongoing efforts to address clinician stress and preparedness, we will strategically disseminate the simulation intervention to areas most impacted by COVID-19. Using a virtual telesimulation and webinar format, the dissemination efforts will provide hands-on learning for ED and hospital administrators as well as simulation educators., Trial Registration Number: NCT04614844., Competing Interests: Competing interests: AHW reported receiving grants from Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research Award and grants from NIH K23MH126366 outside the conduct of the study. JMR reported receiving grants from NIH R01MD014853 and American Medical Association Foundation outside the conduct of the study., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Importance: Quality of care of young adults with acute myocardial infarction (AMI) may depend on health care systems in addition to individual-level factors such as biological sex and social determinants of health (SDOH)., Objective: To examine whether the quality of in-hospital and postacute care among young adults with AMI differs between the US and Canada and whether female sex and adverse SDOH are associated with a low quality of care., Design, Setting, and Participants: This retrospective cohort analysis used data from 2 large cohorts of young adults (aged ≤55 years) receiving in-hospital and outpatient care for AMI at 127 centers in the US and Canada. Data were collected from August 21, 2008, to April 30, 2013, and analyzed from July 12, 2019, to March 10, 2021., Exposures: Sex, SDOH, and health care system., Main Outcomes and Measures: Opportunity-based quality-of-care score (QCS), determined by dividing the total number of quality indicators of care received by the total number for which the patient was eligible, with low quality of care defined as the lowest tertile of the QCS., Results: A total of 4048 adults with AMI (2345 women [57.9%]; median age, 49 [interquartile range, 44-52] years; 3004 [74.2%] in the US) were included in the analysis. Of 3416 patients with in-hospital QCS available, 1061 (31.1%) received a low QCS, including more women compared with men (725 of 2007 [36.1%] vs 336 of 1409 [23.8%]; P < .001) and more patients treated in the US vs Canada (962 of 2646 [36.4%] vs 99 of 770 [12.9%]; P < .001). Conversely, low quality of post-AMI care (748 of 2938 [25.5%]) was similarly observed for both sexes, with a higher prevalence in the US (678 of 2346 [28.9%] vs 70 of 592 [11.8%]). In adjusted analyses, female sex was not associated with low QCS for in-hospital (odds ratio [OR], 1.05; 95% CI, 0.87-1.28) and post-AMI (OR, 1.07; 95% CI, 0.88-1.30) care. Conversely, being treated in the US was associated with low in-hospital (OR, 2.93; 95% CI, 2.16-3.99) and post-AMI (OR, 2.67; 95% CI, 1.97-3.63) QCS, regardless of sex. Of all SDOH, only employment was associated with higher quality of in-hospital care (OR, 0.72; 95% CI, 0.59-0.88). Finally, only in the US, low quality of in-hospital care was associated with a higher 1-year cardiac readmissions rate (234 of 962 [24.3%])., Conclusions and Relevance: These findings suggest that beyond sex, health care systems and SDOH that depict social vulnerability are associated with quality of AMI care. Taking into account SDOH among young adults with AMI may improve quality of care and reduce readmissions, especially in the US.

Introduction: Emergency department (ED) visits for behavioural conditions are rising, with 1.7 million associated episodes of patient agitation occurring annually in acute care settings. When de-escalation techniques fail during agitation management, patients are subject to use of physical restraints and sedatives, which are associated with up to 37% risk of hypotension, apnoea and physical injuries. At the same time, ED staff report workplace violence due to physical assaults during agitation events. We recently developed a theoretical framework to characterise ED agitation, which identified teamwork as a critical component to reduce harm. Currently, no structured team response protocol for ED agitation addressing both patient and staff safety exists., Methods and Analysis: Our proposed study aims to develop and implement the agitation code team (ACT) response intervention, which will consist of a standardised, structured process with defined health worker roles/responsibilities, work processes and clinical protocols. First, we will develop the ACT response intervention in a two-step design loop; conceptual design will engage users in the creation of the prototype, and iterative refinement will occur through in situ simulated agitated patient encounters in the ED to assess and improve the design. Next, we will pilot the intervention in the clinical environment and use a controlled interrupted time series design to evaluate its effect on our primary outcome of patient restraint use. The intervention will be considered efficacious if we effectively lower the rate of restraint use over a 6-month period., Ethics and Dissemination: Ethical approval by the Yale University Human Investigation Committee was obtained in 2019 (HIC #2000025113). Results will be disseminated through peer-reviewed publications and presentations at scientific meetings for each phase of the study. If this pilot is successful, we plan to formally integrate the ACT response intervention into clinical workflows at all EDs within our entire health system., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Clinical research in neurodevelopmental disorders remains reliant upon clinician and caregiver measures. Limitations of these approaches indicate a need for objective, quantitative, and reliable biomarkers to advance clinical research. Extant research suggests the potential utility of multiple candidate biomarkers; however, effective application of these markers in trials requires additional understanding of replicability, individual differences, and intra-individual stability over time. The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is a multi-site study designed to investigate a battery of electrophysiological (EEG) and eye-tracking (ET) indices as candidate biomarkers for autism spectrum disorder (ASD). The study complements published biomarker research through: inclusion of large, deeply phenotyped cohorts of children with ASD and typical development; a longitudinal design; a focus on well-evidenced candidate biomarkers harmonized with an independent sample; high levels of clinical, regulatory, technical, and statistical rigor; adoption of a governance structure incorporating diverse expertise in the ASD biomarker discovery and qualification process; prioritization of open science, including creation of a repository containing biomarker, clinical, and genetic data; and use of economical and scalable technologies that are applicable in developmental populations and those with special needs. The ABC-CT approach has yielded encouraging results, with one measure accepted into the FDA's Biomarker Qualification Program to date. Through these advances, the ABC-CT and other biomarker studies in progress hold promise to deliver novel tools to improve clinical trials research in ASD., (Copyright © 2020 McPartland, Bernier, Jeste, Dawson, Nelson, Chawarska, Earl, Faja, Johnson, Sikich, Brandt, Dziura, Rozenblit, Hellemann, Levin, Murias, Naples, Platt, Sabatos-DeVito, Shic, Senturk, Sugar, Webb and the Autism Biomarkers Consortium for Clinical Trials.)

Buprenorphine (BUP) can safely and effectively reduce craving, overdose, and mortality rates in people with opioid use disorder (OUD). However, adoption of ED-initiation of BUP has been slow partly due to physician perception this practice is too complex and disruptive. We report progress of the ongoing EMBED ( EMergency department-initiated BuprenorphinE for opioid use Disorder) project. This project is a five-year collaboration across five healthcare systems with the goal to develop, integrate, study, and disseminate user-centered Clinical Decision Support (CDS) to promote the adoption of Emergency Department (ED)-initiation of buprenorphine/naloxone (BUP) into routine emergency care. Soon to enter its third year, the project has already completed multiple milestones to achieve its goals including (1) user-centered design of the CDS prototype, (2) integration of the CDS into an automated electronic health record (EHR) workflow, (3) data coordination including derivation and validation of an EHR-based computable phenotype, (4) meeting all ethical and regulatory requirements to achieve a waiver of informed consent, (5) pilot testing of the intervention at a single site, and (6) launching a parallel group-randomized 18-month pragmatic trial in 20 EDs across 5 healthcare systems. Pilot testing of the intervention in a single ED was associated with increased rates of ED-initiated BUP and naloxone prescribing and a doubling of the number of unique physicians adopting the practice. The ongoing multi-center pragmatic trial will assess the intervention's effectiveness, scalability, and generalizability with a goal to shift the emergency care paradigm for OUD towards early identification and treatment., Trial Registration: Clinicaltrials.gov # NCT03658642., Competing Interests: CONFLICTS OF INTEREST The authors have no financial conflicts or competing interests to disclose.

Background: Deploying accurate computable phenotypes in pragmatic trials requires a trade-off between precise and clinically sensical variable selection. In particular, evaluating the medical encounter to assess a pattern leading to clinically significant impairment or distress indicative of disease is a difficult modeling challenge for the emergency department., Objective: This study aimed to derive and validate an electronic health record-based computable phenotype to identify emergency department patients with opioid use disorder using physician chart review as a reference standard., Methods: A two-algorithm computable phenotype was developed and evaluated using structured clinical data across 13 emergency departments in two large health care systems. Algorithm 1 combined clinician and billing codes. Algorithm 2 used chief complaint structured data suggestive of opioid use disorder. To evaluate the algorithms in both internal and external validation phases, two emergency medicine physicians, with a third acting as adjudicator, reviewed a pragmatic sample of 231 charts: 125 internal validation (75 positive and 50 negative), 106 external validation (56 positive and 50 negative)., Results: Cohen kappa, measuring agreement between reviewers, for the internal and external validation cohorts was 0.95 and 0.93, respectively. In the internal validation phase, Algorithm 1 had a positive predictive value (PPV) of 0.96 (95% CI 0.863-0.995) and a negative predictive value (NPV) of 0.98 (95% CI 0.893-0.999), and Algorithm 2 had a PPV of 0.8 (95% CI 0.593-0.932) and an NPV of 1.0 (one-sided 97.5% CI 0.863-1). In the external validation phase, the phenotype had a PPV of 0.95 (95% CI 0.851-0.989) and an NPV of 0.92 (95% CI 0.807-0.978)., Conclusions: This phenotype detected emergency department patients with opioid use disorder with high predictive values and reliability. Its algorithms were transportable across health care systems and have potential value for both clinical and research purposes., (©David Chartash, Hyung Paek, James D Dziura, Bill K Ross, Daniel P Nogee, Eric Boccio, Cory Hines, Aaron M Schott, Molly M Jeffery, Mehul D Patel, Timothy F Platts-Mills, Osama Ahmed, Cynthia Brandt, Katherine Couturier, Edward Melnick. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 31.10.2019.)

Introduction: The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD)., Methods: A pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site., Ethics and Dissemination: The protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications., Trial Registration Number: NCT03658642; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Physicians "purchase" many health care services on behalf of patients yet remain largely unaware of the costs of these services. Electronic health record (EHR) cost displays may facilitate cost-conscious ordering of health services., Objective: To determine whether displaying hospital lab and imaging order costs is associated with changes in the number and costs of orders placed., Design: Quasi-experimental study., Participants: All patients with inpatient or observation encounters across a multi-site health system from April 2013 to October 2015., Intervention: Display of order costs, based on Medicare fee schedules, in the EHR for 1032 lab tests and 1329 imaging tests., Main Measures: Outcomes for both lab and imaging orders were (1) whether an order was placed during a hospital encounter, (2) whether an order was placed on a given patient-day, (3) number of orders placed per patient-day, and (4) cost of orders placed per patient-day., Key Results: During the lab and imaging study periods, there were 248,214 and 258,267 encounters, respectively. Cost display implementation was associated with a decreased odds of any lab or imaging being ordered during the encounter (lab adjusted odds ratio [AOR] = 0.97, p = .01; imaging AOR = 0.97, p < .001), a decreased odds of any lab or imaging being ordered on a given patient-day (lab AOR = 0.95, p < .001; imaging AOR = 0.97, p < .001), a decreased number of lab or imaging orders on patient-days with orders (lab adjusted count ratio = 0.93, p < .001; imaging adjusted count ratio = 0.98, p < .001), and a decreased cost of lab orders and increased cost of imaging orders on patient-days with orders (lab adjusted cost ratio = 0.93, p < .001; imaging adjusted cost ratio = 1.02, p = .003). Overall, the intervention was associated with an 8.5 and 1.7% reduction in lab and imaging costs per patient-day, respectively., Conclusions: Displaying costs within EHR ordering screens was associated with decreases in the number and costs of lab and imaging orders.

Background: We compared the clinical characteristics and outcomes of young patients with myocardial infarction with nonobstructive coronary arteries (MINOCA) versus obstructive disease (myocardial infarction due to coronary artery disease [MI-CAD]) and among patients with MINOCA by sex and subtype., Methods and Results: Between 2008 and 2012, VIRGO (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients) prospectively enrolled acute myocardial infarction patients aged 18 to 55 years in 103 hospitals at a 2:1 ratio of women to men. Using an angiographically driven taxonomy, we defined patients as having MI-CAD if there was revascularization or plaque ≥50% and as having MINOCA if there was <50% obstruction or a nonplaque mechanism. Patients who did not have an angiogram or who received thrombolytics before an angiogram were excluded. Outcomes included 1- and 12-month mortality and functional (Seattle Angina Questionnaire [SAQ]) and psychosocial status. Of 2690 patients undergoing angiography, 2374 (88.4%) had MI-CAD, 299 (11.1%) had MINOCA, and 17 (0.6%) remained unclassified. Women had 5 times higher odds of having MINOCA than men (14.9% versus 3.5%; odds ratio: 4.84; 95% confidence interval, 3.29-7.13). MINOCA patients were more likely to be without traditional cardiac risk factors (8.7% versus 1.3%; P <0.001) but more predisposed to hypercoaguable states than MI-CAD patients (3.0% versus 1.3%; P =0.036). Women with MI-CAD were more likely than those with MINOCA to be menopausal (55.2% versus 41.2%; P <0.001) or to have a history of gestational diabetes mellitus (16.8% versus 11.0%; P =0.028). The MINOCA mechanisms varied: a nonplaque mechanism was identified for 75 patients (25.1%), and their clinical profiles and management also varied. One- and 12-month mortality with MINOCA and MI-CAD was similar (1-month: 1.1% and 1.7% [ P =0.43]; 12-month: 0.6% and 2.3% [ P =0.68], respectively), as was adjusted 12-month SAQ quality of life (76.5 versus 73.5, respectively; P =0.06)., Conclusions: Young patients with MINOCA were more likely women, had a heterogeneous mechanistic profile, and had clinical outcomes that were comparable to those of MI-CAD patients., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00597922., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Human immunodeficiency virus (HIV) disproportionately impacts minority youth. Interventions to decrease HIV sexual risk are needed., Objective: We hypothesized that an engaging theory-based digital health intervention in the form of an interactive video game would improve sexual health outcomes in adolescents., Methods: Participants aged 11 to 14 years from 12 community afterschool, school, and summer programs were randomized 1:1 to play up to 16 hours of an experimental video game or control video games over 6 weeks. Assessments were conducted at 6 weeks and at 3, 6, and 12 months. Primary outcome was delay of initiation of vaginal/anal intercourse. Secondary outcomes included sexual health attitudes, knowledge, and intentions. We examined outcomes by gender and age., Results: A total of 333 participants were randomized to play the intervention (n=166) or control games (n=167): 295 (88.6%) were racial/ethnic minorities, 177 (53.2%) were boys, and the mean age was 12.9 (1.1) years. At 12 months, for the 258 (84.6%) participants with available data, 94.6% (122/129) in the intervention group versus 95.4% (123/129) in the control group delayed initiation of intercourse (relative risk=0.99, 95% CI 0.94-1.05, P=.77). Over 12 months, the intervention group demonstrated improved sexual health attitudes overall compared to the control group (least squares means [LS means] difference 0.37, 95% CI 0.01-0.72, P=.04). This improvement was observed in boys (LS means difference 0.67, P=.008), but not girls (LS means difference 0.06, P=.81), and in younger (LS means difference 0.71, P=.005), but not older participants (LS means difference 0.03, P=.92). The intervention group also demonstrated increased sexual health knowledge overall (LS means difference 1.13, 95% CI 0.64-1.61, P<.001), in girls (LS means difference 1.16, P=.001), boys (LS means difference 1.10, P=.001), younger (LS means difference 1.18, P=.001), and older (LS means difference=1.08, P=.002) participants. There were no differences in intentions to delay the initiation of intercourse between the two groups (LS means difference 0.10, P=.56)., Conclusions: An interactive video game intervention improves sexual health attitudes and knowledge in minority adolescents for at least 12 months., Trial Registration: Clinicaltrials.gov NCT01666496; https://clinicaltrials.gov/ct2/show/NCT01666496 (Archived by WebCite at http://www.webcitation.org/6syumc9C0)., (©Lynn E Fiellin, Kimberly D Hieftje, Tyra M Pendergrass, Tassos C Kyriakides, Lindsay R Duncan, James D Dziura, Benjamin G Sawyer, Linda Mayes, Cindy A Crusto, Brian WC Forsyth, David A Fiellin. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.09.2017.)

Objective: The Diabetes Prevention Program (DPP) demonstrated that weight loss from intensive lifestyle intervention (ILI) in adults with prediabetes could decrease progression to type 2 diabetes. Inner-city, low-income Hispanic women are at high risk for developing type 2 diabetes; however, this type of intervention is not well established in this group. We hypothesized that a DPP intervention modified for a community health center (CHC) setting would decrease weight and improve metabolic measures in Hispanic women with prediabetes., Research Design and Methods: Women diagnosed with prediabetes on a screening oral glucose tolerance test were recruited from a CHC. Participants (90% of whom were Hispanic) were randomized to either usual care (age 43 ± 9.7 years, BMI 35.2 ± 7.3 kg/m(2)) or ILI (age 43.8 ± 10.8 years, BMI 35.4 ± 8.5 kg/m(2)), structured as 14 weeks of group sessions focused on food choices, behavior change, physical activity, and weight loss. One year after enrollment, 122 women repeated baseline measures., Results: Groups had similar baseline weight, BMI, and fasting and 2-h glucose. One year later, the ILI group had lost 3.8 kg (4.4%), while the usual care group had gained 1.4 kg (1.6%, P < 0.0001). Two-hour glucose excursion decreased 15 mg/dL (0.85 mmol/L) in the ILI and 1 mg/dL (0.07 mmol/L) in the usual care group (P = 0.03). Significant decreases favoring the ILI group were noted in BMI, percent body fat, waist circumference, and fasting insulin., Conclusions: A 14-week ILI program based on the DPP can effectively be translated into a predominantly Hispanic CHC setting, resulting in decreased weight, improved fasting insulin, and smaller glucose excursions 1 year after enrolling in the program., (© 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.)

Background: Little is known about the environmental and public health impact of unconventional natural gas extraction activities, including hydraulic fracturing, that occur near residential areas., Objectives: Our aim was to assess the relationship between household proximity to natural gas wells and reported health symptoms., Methods: We conducted a hypothesis-generating health symptom survey of 492 persons in 180 randomly selected households with ground-fed wells in an area of active natural gas drilling. Gas well proximity for each household was compared with the prevalence and frequency of reported dermal, respiratory, gastrointestinal, cardiovascular, and neurological symptoms., Results: The number of reported health symptoms per person was higher among residents living < 1 km (mean ± SD, 3.27 ± 3.72) compared with > 2 km from the nearest gas well (mean ± SD, 1.60 ± 2.14; p = 0.0002). In a model that adjusted for age, sex, household education, smoking, awareness of environmental risk, work type, and animals in house, reported skin conditions were more common in households < 1 km compared with > 2 km from the nearest gas well (odds ratio = 4.1; 95% CI: 1.4, 12.3; p = 0.01). Upper respiratory symptoms were also more frequently reported in persons living in households < 1 km from gas wells (39%) compared with households 1-2 km or > 2 km from the nearest well (31 and 18%, respectively) (p = 0.004). No equivalent correlation was found between well proximity and other reported groups of respiratory, neurological, cardiovascular, or gastrointestinal conditions., Conclusion: Although these results should be viewed as hypothesis generating, and the population studied was limited to households with a ground-fed water supply, proximity of natural gas wells may be associated with the prevalence of health symptoms including dermal and respiratory conditions in residents living near natural gas extraction activities. Further study of these associations, including the role of specific air and water exposures, is warranted.

The purpose of this study was to determine if third-year medical students participating in a mandatory 12-week simulation course perceived improvement in decision-making, communication, and teamwork skills. Students participated in or observed 24 acute emergency scenarios. At 4-week intervals, students completed 0-10 point Likert scale questionnaires evaluating the curriculum and role of team leader. Linear contrasts were used to examine changes in outcomes. P-values were Bonferroni-corrected for multiple pairwise comparisons. Student evaluations (n = 96) demonstrated increases from week 4 to 12 in educational value (p = 0.006), decision-making (p < 0.001), communication (p = 0.02), teamwork (p = 0.01), confidence in management (p < 0.001), and translation to clinical experience (p < 0.001). Regarding the team leader role, students reported a decrease in stress (p = 0.001) and increase in ability to facilitate team function (p < 0.001) and awareness of team building (p = <0.001). Ratings demonstrate a positive impact of simulation on both clinical management skills and team leadership skills. A simulation curriculum can enhance the ability to manage acute clinical problems and translates well to the clinical experience. These positive perceptions increase as the exposure to simulation increases.

Randomized clinical trials are the gold standard for evaluating interventions as randomized assignment equalizes known and unknown characteristics between intervention groups. However, when participants miss visits, the ability to conduct an intent-to-treat analysis and draw conclusions about a causal link is compromised. As guidance to those performing clinical trials, this review is a non-technical overview of the consequences of missing data and a prescription for its treatment beyond the typical analytic approaches to the entire research process. Examples of bias from incorrect analysis with missing data and discussion of the advantages/disadvantages of analytic methods are given. As no single analysis is definitive when missing data occurs, strategies for its prevention throughout the course of a trial are presented. We aim to convey an appreciation for how missing data influences results and an understanding of the need for careful consideration of missing data during the design, planning, conduct, and analytic stages.

Background: Resident physicians are at risk for increasing weight status given their changes in environment, resources, and stress level., Objective: To describe body mass index (BMI), blood pressure, eating habits, and physical activity during postgraduate training and to compare the findings to data for nationally matched controls., Methods: This was a combined cross-sectional study and longitudinal cohort, with a comparison to matched controls in 2 academic hospital centers in the eastern and western United States. BMI and blood pressure were objectively measured, and an eating and exercise habits recall was obtained for 375 enrolled medical and surgical residents (93 longitudinally) at the onset of each postgraduate year (PGY) in 2006, 2007, and 2008., Results: Nearly half (43%) of overweight residents described themselves as normal weight. Residents were more likely to be overweight (BMI ≥25) at the beginning of PGY-3 than at the beginning of PGY-1 (49% versus 30%; odds ratio 2.26; 95% confidence interval 1.19-4.28). The average BMI of residents at PGY-1 was lower than that of their matched controls, but the magnitude of this difference decreased with increasing PGY (P  =  .02)., Conclusions: Overweight status is underacknowledged by overweight residents and increases by PGY of training. These changes differ significantly from that of controls and may affect overweight physicians' long-term health.

Since 1996, states have been implementing and enhancing their graduated driver licensing (GDL) programs. Increased licensing restrictions could steer new drivers to bypass training and licensing altogether. Unlicensed driving is associated with increased fatal crashes and high-risk behaviors that have been shown to adversely affect passenger safety behaviors like restraint use. The objective of this study was to assess the impact of varying state level GDL programs on rates of unlicensed driving and on passenger restraint use. De-identified data from the National Highway Traffic Safety Administration's Fatality Analysis Reporting System from years 1996-2010 was analyzed. Fatal crashes involving drivers (15-24 yrs) and their passengers (15-24 yrs) were included. Using a validated system, each state's GDL laws at a given month were rated as poor, marginal, fair, or good. The association between GDL strength and unlicensed driving was analyzed graphically and by chi-square test. Multivariate logistic regression with generalized estimating equations were undertaken to assess the relationship between GDL strength and passenger restraint use. From January 1996 to December 2010, 26,504 (23.4%) passengers were involved in fatal crashes taking place in states with GDL programs rated poor, 21,366(18.9%) marginal, 33,603 (29.6%) fair, and 31,903 (28.1%) good. Rates of unlicensed driving ranged from 16.4% in state-months rated marginal versus 21.5% in state-months rated good (p<0.001). In the multivariate model, compared to states with poor GDL ratings, each additional rating boost was associated with an increased odds of passenger safety restraint use (OR 1.15, 95% CI 1.13-1.18). Our findings suggest that stronger GDL law can mitigate passenger risk in fatal crashes by encouraging passenger restraint use. Our study provides evidence that stronger legislation in these states may reduce overall risk to young drivers and their passengers.

Young unlicensed drivers are more likely to be in fatal crashes and to engage in high-risk driving behaviors like impaired driving, speeding, and driving unrestrained. In a crash context, the influence of these high-risk behaviors may spillover to adversely affect passenger safety restraint use. We conducted an analysis of the Fatality Analysis Reporting System from years 1996-2008. Fatal crashes involving a driver aged 15-24 years and at least one passenger aged 15-24 years were included. Logistic regression with generalized estimating equations was undertaken to assess the effect of unlicensed driving on passenger restraint use. We controlled for established predictors of passenger restraint use including driver restraint use, gender, number of occupants, driver drinking, number of occupants, crash year, and crash location (rural vs. urban). 102,092 passengers were involved in fatal crashes during the time period with 64,803 unique drivers. 6,732 (10.51%) were never licensed drivers and 5,603 (8.8%) were drivers with suspended, revoked, or expired licenses. Rates of unlicensed driving ranged from 17.7% to 22.1% and increased over time. While passengers in fatal crashes averaged a mere 40.9% restraint use, passengers of never and invalidly licensed drivers had a further decreased odds of wearing a safety restraint (OR 0.73, 95% CI 0.69-0.77, p<0.001) and (OR 0.84, 95% CI 0.79-0.90, p<0.001). Unlicensed driving is involved in a disproportionate and increasing number of preventable crash fatalities and plays a detrimental role in the lifesaving safety behaviors of their passengers. Our findings highlight an alarming peer influence between unlicensed drivers and passengers, placing increased emphasis on the need to better understand and characterize this present and growing threat.

Objective: The purpose of this study was to examine the effect of type of insulin analog and age of insertion site on the pharmacodynamic characteristics of a standard insulin bolus in youth with type 1 diabetes receiving insulin pump therapy., Research Design and Methods: Seventeen insulin pump-treated adolescents with type 1 diabetes underwent two euglycemic clamp procedures after a 0.2 unit/kg bolus of either insulin aspart or lispro on day 1 and day 4 of insulin pump site insertion. The glucose infusion rate (GIR) required to maintain euglycemia was the primary pharmacodynamic measure., Results: There were no statistically significant differences in any of the pharmacodynamic parameters between aspart and lispro during day 1 and day 4. However, when the two groups were combined, time to discontinuation of exogenous glucose infusion, and time to half-maximal onset and offset of insulin action were observed significantly earlier during day 4 compared with day 1 (P = 0.03-0.0004), but the overall area under the GIR curve was similar on day 1 and day 4., Conclusions: With both insulin aspart and lispro, there is an earlier peak and shorter duration of action with increasing duration of infusion site use, but overall insulin action is not affected.

Objective: To examine whether delayed surgical intervention in adult patients with acute appendicitis is safe by correlating the interval from onset of symptoms to operation (total interval) with the degree of pathology and incidence of postoperative complications., Summary Background Data: Prompt appendectomy has long been the standard of care for acute appendicitis because of the risk of progression to advanced pathology. This time-honored practice has been recently challenged by studies in pediatric patients, which suggested that acute appendicitis can be managed in an elective manner once antibiotic therapy is initiated. No such data are available in adult patients with acute appendicitis., Methods: A retrospective review of 1081 patients who underwent an appendectomy for acute appendicitis between 1998 and 2004 was conducted. The following parameters were monitored and correlated: demographics, time from onset of symptoms to arrival at the emergency room (patient interval) and from arrival to the emergency room to the operating room (hospital interval), physical, computed tomography (CT scan) and pathologic findings, complications, length of stay, and length of antibiotic treatment. Pathologic state was graded 1 (G1) for acute appendicitis, 2 (G2) for gangrenous acute appendicitis, 3 (G3) for perforation or phlegmon, and 4 (G4) for a periappendicular abscess., Results: The risk of advanced pathology, defined as a higher pathology grade, increased with the total interval. When this interval was <12 hours, the risk of developing G1, G2, G3, and G4, was 94%, 0%, 3%, and 3%, respectively. These values changed to 60%, 7%, 27%, and 6%, respectively, when the total interval was 48 to 71 hours and to 54%, 7%, 26%, and 13% for longer than 71 hours. The odds for progressive pathology was 13 times higher for the total interval >71 hours group compared with total interval<12 hours (95% confidence interval = 4.7-37.1). Although both prolonged patient and hospital intervals were associated with advanced pathology, prehospital delays were more profoundly related to worsening pathology compared with in-hospital delays (P < 0.001). Advanced pathology was associated with tenderness to palpation beyond the right lower quadrant (P < 0.001), guarding (P < 0.001), rebound (P < 0.001), and CT scan findings of peritoneal fluid (P = 0.01), fecalith (P = 0.01), dilation of the appendix (P < 0.001), and perforation (P < 0.001). Increased length of hospital stay (P < 0.001) and antibiotic treatment (P < 0.001) as well as postoperative complications (P < 0.001) also correlated with progressive pathology., Conclusion: In adult patients with acute appendicitis, the risk of developing advanced pathology and postoperative complications increases with time; therefore, delayed appendectomy is unsafe. As delays in seeking medical help are difficult to control, prompt appendectomy is mandatory. Because these conclusions are derived from retrospective data, a prospective study is required to confirm their validity.

Objective: Early postoperative arrhythmias are a known complication of cardiac surgery; however, little data exists specific to pediatrics. The purpose of this study was to determine the incidence and risk factors associated with the development of arrhythmias immediately after surgery in a pediatric population., Methods: Data were collected in a prospective observational format from pediatric patients undergoing cardiac surgery between September 2000 and May 2003. This format included age, anatomy, surgical repair, and serum magnesium and calcium levels, as well as cardiopulmonary bypass and aortic crossclamp times. Patients were continuously monitored, and hemodynamically significant arrhythmias were recorded., Results: Arrhythmias occurred in 28 of the 189 patients enrolled (15%) including 16 with junctional ectopic tachycardia, 7 with complete atrioventricular block, 4 with ventricular tachycardia, and 1 with re-entrant supraventricular tachycardia. Significant differences were found between the arrhythmia and nonarrhythmia groups with regard to age (22 vs 45 months), cardiopulmonary bypass time (189 vs 109 minutes), and aortic crossclamp time (105 vs 44 minutes); P < .05. Magnesium and calcium levels were not significantly different between the groups. Two repairs carried an increased risk: complete atrioventricular septal defect repair, 8 of 11 patients (72%), and the arterial switch 5 of 8 patients (62.5%); P < .05. Atrioventricular septal defects had an even higher incidence when controlled for age, bypass time, and crossclamp time (odds ratio = 7.65)., Conclusions: Hemodynamically significant postoperative arrhythmias are a frequent complication of pediatric cardiac surgery. Younger age and longer bypass and crossclamp times are risk factors for arrhythmia. In addition, the repair of atrioventricular septal defects carries an independent risk of arrhythmias.

Hypoglycemia-associated autonomic failure (HAAF) occurs commonly in patients with longstanding diabetes, placing affected patients at increased risk for severe hypoglycemia. Previous studies have suggested that hypoglycemia-induced hypercortisolemia may be responsible for blunting subsequent sympathoadrenal responses to hypoglycemia; however, this view remains highly controversial. In this work, we sought to better define the role of antecedent hypercortisolemia in generating HAAF, using two complimentary experimental models in nondiabetic human subjects: 1) antecedent hydrocortisone infusions (simulating physiologic cortisol responses to hypoglycemia) and 2) antecedent hypoglycemia, with and without concurrent blockade of endogenous cortisol production using oral metyrapone. Our results showed no effect of antecedent hypercortisolemia on epinephrine responses to subsequent hypoglycemia (area under the curve/time 280 +/- 53 vs. 337 +/- 57 pg/ml, P = 0.16). Of particular importance, selective blockade of endogenous cortisol production during antecedent hypoglycemia had no effect on subsequent counterregulatory responses to hypoglycemia. Compared with epinephrine responses following antecedent euglycemia (area under the curve/time 312 +/- 38 pg/ml), epinephrine responses were comparably blunted following antecedent hypoglycemia, regardless of whether concurrent metyrapone blockade was employed (198 +/- 28 vs. 192 +/- 28 pg/ml, P = NS). Similar results were obtained for glucagon and ACTH levels. Considered together, these observations provide strong evidence that hypoglycemia-induced hypercortisolemia is not primarily responsible for the generation of HAAF.

Aims/hypothesis: The prevalence of altered glucose metabolism in obese children and adolescents is growing at a significant rate, especially in ethnic minorities. It is not clear whether young people of different ethnic backgrounds differ in their adaptive mechanisms to obesity-related insulin resistance. The aim of this study was to evaluate the early insulin response and insulin clearance in response to an oral glucose load in obese children and adolescents., Methods: Seven hundred and nine obese children and adolescents underwent an OGTT. Indices of the early insulin response and insulin clearance were compared in participants of White European, African American and Hispanic origin., Results: Participants of the three ethnic groups demonstrated similar mechanisms of adaptation to increasing insulin resistance, but with different magnitudes. African American subjects had a greater early insulin response and decreased insulin clearance than their White European and Hispanic counterparts. This happened regardless of whether the cohort was divided by glucose tolerance level or by level of insulin sensitivity. IGT across ethnic groups was characterised by a marked decline in the acute insulin response in the context of severe insulin resistance and very low insulin clearance., Conclusions/interpretation: In obese children and adolescents, mechanisms of adaptation to obesity related to insulin resistance are similar across ethnic groups. The greater early insulin response needed to maintain glucose tolerance in young people of ethnic minorities may partially explain their greater tendency to develop type 2 diabetes.

Objective: In a recent randomized controlled trial, lowering blood glucose levels to 80-110 mg/dl improved clinical outcomes in critically ill patients. In that study, the insulin infusion protocol (IIP) used to normalize blood glucose levels provided valuable guidelines for adjusting insulin therapy. In our hands, however, ongoing expert supervision was required to effectively manage the insulin infusions. This work describes our early experience with a safe, effective, nurse-implemented IIP that provides detailed insulin dosing instructions and requires minimal physician input., Research Design and Methods: We collected data from 52 medical intensive care unit (MICU) patients who were placed on the IIP. Blood glucose levels were the primary outcome measurement. Relevant clinical variables and insulin requirements were also recorded. MICU nurses were surveyed regarding their experience with the IIP., Results: To date, our IIP has been employed 69 times in 52 patients admitted to an MICU. Using the IIP, the median time to reach target blood glucose levels (100-139 mg/dl) was 9 h. Once blood glucose levels fell below 140 mg/dl, 52% of 5,808 subsequent hourly blood glucose values fell within our narrow target range; 66% within a "clinically desirable" range of 80-139 mg/dl; and 93% within a "clinically acceptable" range of 80-199 mg/dl. Only 20 (0.3%) blood glucose values were <60 mg/dl, none of which resulted in clinically significant adverse events. In general, the IIP was readily accepted by our MICU nursing staff, most of whom rated the protocol as both clinically effective and easy to use., Conclusions: Our nurse-implemented IIP is safe and effective in improving glycemic control in critically ill patients.