Barriers to and solutions for representative inclusion across the lifespan and in life course research: The need for structural competency highlighted by the COVID-19 pandemic.

Exclusion of special populations (older adults; pregnant women, children, and adolescents; individuals of lower socioeconomic status and/or who live in rural communities; people from racial and ethnic minority groups; individuals from sexual or gender minority groups; and individuals with disabilities) in research is a pervasive problem, despite efforts and policy changes by the National Institutes of Health and other organizations. These populations are adversely impacted by social determinants of health (SDOH) that reduce access and ability to participate in biomedical research. In March 2020, the Northwestern University Clinical and Translational Sciences Institute hosted the "Lifespan and Life Course Research: integrating strategies" "Un-Meeting" to discuss barriers and solutions to underrepresentation of special populations in biomedical research. The COVID-19 pandemic highlighted how exclusion of representative populations in research can increase health inequities. We applied findings of this meeting to perform a literature review of barriers and solutions to recruitment and retention of representative populations in research and to discuss how findings are important to research conducted during the ongoing COVID-19 pandemic. We highlight the role of SDOH, review barriers and solutions to underrepresentation, and discuss the importance of a structural competency framework to improve research participation and retention among special populations.

PEMCRC anaphylaxis study protocol: a multicentre cohort study to derive and validate clinical decision models for the emergency department management of children with anaphylaxis.

INTRODUCTION: There remain significant knowledge gaps about the management and outcomes of children with anaphylaxis. These gaps have led to practice variation regarding decisions to hospitalise children and length of observation periods following treatment with epinephrine. The objectives of this multicentre study are to (1) determine the prevalence of and risk factors for severe, persistent, refractory and biphasic anaphylaxis, as well as persistent and biphasic non-anaphylactic reactions; (2) derive and validate prediction models for emergency department (ED) discharge; and (3) determine data-driven lengths of ED and inpatient observation prior to discharge to home based on initial reaction severity. METHODS AND ANALYSIS: The study is being conducted through the Pediatric Emergency Medicine Collaborative Research Committee (PEMCRC). Children 6 months to less than 18 years of age presenting to 30 participating EDs for anaphylaxis from October 2015 to December 2019 will be eligible. The primary outcomes for each objective are (1) severe, persistent, refractory or biphasic anaphylaxis, as well as persistent or biphasic non-anaphylactic reactions; (2) safe ED discharge, defined as no receipt of acute anaphylaxis medications or hypotension beyond 4 hours from first administered dose of epinephrine; and (3) time from first to last administered dose of epinephrine and vasopressor cessation. Analyses for each objective include (1) descriptive statistics to estimate prevalence and generalised estimating equations that will be used to investigate risk factors for anaphylaxis outcomes, (2) least absolute shrinkage and selection operator regression and binary recursive partitioning to derive and validate prediction models of children who may be candidates for safe ED discharge, and (3) Kaplan-Meier analyses to assess timing from first to last epinephrine doses and vasopressor cessation based on initial reaction severity. ETHICS AND DISSEMINATION: All sites will obtain institutional review board approval; results will be published in peer-reviewed journals and disseminated via traditional and social media, blogs and online education platforms.

Interobserver Agreement in the Assessment of Clinical Findings in Children with Headaches.

OBJECTIVE: To determine the interobserver agreement of history and physical examination findings in children undergoing evaluation in the emergency department (ED) for headaches. STUDY DESIGN: We conducted a prospective, cross-sectional study of children aged 2-17 years evaluated at 3 tertiary-care pediatric EDs for non-traumatic headaches. Two clinicians independently completed a standardized assessment of each child and documented the presence or absence of history and physical examination variables. Unweighted κ statistics were determined for 68 history and 24 physical examination variables. RESULTS: We analyzed 191 paired observations; median age was 12 years, with 19 (9.9%) children younger than 7 years. Interrater reliability was at least moderate (κ ≥ 0.41) for 41 (60.3%) patient history variables. Eleven (61.1%) of 18 physical examination variables for which κ statistics could be calculated had a κ that was at least moderate. CONCLUSIONS: A substantial number of history and physical examination findings demonstrated at least moderate κ statistic values when assessed in children with headaches in the ED. These variables may be generalizable across different types of clinicians for evaluation of children with headaches. If also found to predict the presence or absence of emergent intracranial abnormalities, the more reliable clinical findings may be helpful in the development of clinical prediction rules or risk stratification models that could be used across settings for children with headaches.

Engaging Adolescents With Sexual Health Messaging: A Qualitative Analysis.

PURPOSE: Personalized and interactive text messaging interventions may increase participant engagement; yet, how to design messages that retain adolescent attention and positively affect sexual health behaviors remains unclear. The purpose of this study was to identify the characteristics of sexual health text messages perceived as engaging by sexually active adolescent females. METHODS: We conducted semistructured, open-ended interviews with sexually active females aged 14-19 in one urban emergency department. Participants received automated sexual health information sent via an interactive, two-way texting format. The 343 messages viewed by participants were based on key stakeholder input, relevant theoretical models, and existing evidence-based guidelines. Interviews elicited feedback. Enrollment continued until saturation of themes. Interviews were recorded, transcribed, and coded based on thematic analysis using NVivo 10. RESULTS: Participants (n = 31) were predominantly Hispanic (28; 90%), insured (29; 94%), and recently sexually active (24; 77%). Themes were as follows: (1) Tone: messages should be direct, factual, entertaining, and respect adolescent autonomy; messages should not be intrusive, presumptive, or preachy. (2) Emotion evoked: participants preferred messages that provoked thought, validated feelings, and empowered. Messages from a reliable source felt comforting, making participants feel cared for and special. (3) Interactivity: participants favored messages that offered choices, such as a mini-conversation. (4) Personalization: messages should look similar to adolescent digital preferences but be individually tailored with relatable characters. CONCLUSIONS: This study informs the tone, structure, and style of sexual health text messages directed toward adolescent females in the emergency department. Future work should consider these characteristics when designing digital interventions to engage adolescent females.

A Qualitative Assessment to Understand the Barriers and Enablers Affecting Contraceptive Use Among Adolescent Male Emergency Department Patients.

Early fatherhood is common in the United States (U.S.). The emergency department (ED) plays a disproportionate role in serving patients with unmet reproductive and sexual health needs. With 8 million adolescent males visiting U.S. EDs annually, the ED is a potential site to implement interventions to minimize early fatherhood and unintended teenage pregnancy. Little is known about how adolescent male ED patients perceive and behave in sexual relationships and how they influence contraceptive decision making. The objective of this study was to identify the barriers and enablers affecting contraceptive and condom use among adolescent male ED patients. Semistructured interviews were conducted with males aged 14-19 in one urban ED. Enrollment continued until saturation of key themes. Interviews were recorded, transcribed, and coded based on thematic analysis using NVivo 10. The Social Ecological Model was used to organize and understand themes. Participants ( n = 24) were predominantly 18-19 years (63%) and Hispanic (92%). Most (71%) had sex ≤3 months prior but infrequently used a condom at last intercourse (42%). The primary barrier influencing contraceptive use was lack of knowledge of effective contraceptives. Other barriers consisted of perceived gender roles, poor partner communication, and little relationship with a primary provider. Enablers included intention not to get a partner pregnant, school-based sexual health education, normalcy to use condoms, and a trustworthy confidante. The identified barriers and enablers influencing adolescent males' perspectives toward contraceptives should be addressed if designing future ED-based pregnancy prevention interventions targeting teen males.

Economic Analysis of Diagnostic Imaging in Pediatric Patients With Suspected Appendicitis.

OBJECTIVE: The use of computed tomography (CT) and ultrasound (US) in patients with acute abdominal pain has substantial variation across pediatric emergency departments (EDs). This study compares the cost of diagnosing and treating suspected appendicitis across a multicenter network of children's hospitals. METHODS: This study is a secondary analysis using deidentified data of a prospective, observational study of patients with suspected appendicitis at nine pediatric EDs. The study included patients 3 to 18 years old who presented to the ED with acute abdominal pain of <96 hours' duration. RESULTS: Our data set contained 2,300 cases across nine sites. There was an appendicitis rate of 31.8% and perforation rate of 25.7%. Sites correctly diagnosed appendicitis in over 95% of cases. The negative appendicitis rate ranged from 2.5% to 4.7% while the missed appendicitis rate ranged from 0.3% to 1.1% with no significant differences in these rates across site. Across sites, we found a strong positive correlation (0.95) between CT rate and total cost per case and a strong negative correlation (-0.71) between US rate and cost. The cost per case at US sites was 5.2% ($367) less than at CT sites (p < 0.001). Similarly, costs per case at mixed sites were 3.4% ($244) less than at CT sites (p < 0.001). Comparing costs among CT sites or among US sites, the cost per case generally increased as the images per case increased among both CT sites and US sites, but the costs were universally higher at CT sites. CONCLUSIONS: Our results provide support for US as the primary imaging modality for appendicitis. Sites that preferentially utilized US had lower costs per case than sites that primarily used CT. Imaging rates across sites varied due to practice patterns and resulted in a significant cost consequence without higher rates for negative appendectomies or missed appendicitis cases.

Use of the focused assessment with sonography for trauma (FAST) examination and its impact on abdominal computed tomography use in hemodynamically stable children with blunt torso trauma.

BACKGROUND: The aim of this study was to evaluate the variability of clinician-performed Focused Assessment with Sonography for Trauma (FAST) examinations and its impact on abdominal computed tomography (AbCT) use in hemodynamically stable children with blunt torso trauma (BTT). The FAST is used with variable frequency in children with BTT. METHODS: We performed a planned secondary analysis of children (<18 years) with BTT. Patients with a Glasgow Coma Scale (GCS) score of less than 9, those with hypotension, and those taken directly to the operating suite were excluded. Clinicians documented their suspicion for intra-abdominal injury (IAI) as very low, less than 1%; low, 1% to 5%; moderate, 6% to 10%; high, 11% to 50%; or very high, greater than 50%. We determined the relative risk (RR) for AbCT use based on undergoing a FAST examination in each of these clinical suspicion strata. RESULTS: Of 6,468 (median age, 11.8 years; interquartile range, 6.3-15.5 years) children who met eligibility, 887 (13.7%) underwent FAST examination before CT scan. A total of 3,015 (46.6%) underwent AbCT scanning, and 373 (5.8%) were diagnosed with IAI. Use of the FAST increased as clinician suspicion for IAI increased, 11.0% with less than 1% suspicion for IAI, 13.5% with 1% to 5% suspicion, 20.5% with 6% to 10% suspicion, 23.2% with 11% to 50% suspicion, and 30.7% with greater than 50% suspicion. The patients in whom the clinicians had a suspicion of IAI of 1% to 5% or 6% to 10% were significantly less likely to undergo a CT scan if a FAST examination was performed: RR, 0.83 (0.67-1.03); RR, 0.81 (0.72-0.91); RR, 0.85 (0.78-0.94); RR, 0.99 (0.94-1.05); and RR, 0.97 (0.91-1.05) for patients with clinician suspicion of IAI of less than 1%, 1% to 5%, 6% to 10%, 11% to 50%, and greater than 50%, respectively. CONCLUSION: The FAST examination is used in a relatively small percentage of children with BTT. Use increases as clinician suspicion for IAI increases. Patients with a low or moderate clinician suspicion of IAI are less likely to undergo AbCT if they receive a FAST examination. A randomized controlled trial is required to more precisely determine the benefits and drawbacks of the FAST examination in the evaluation of children with BTT. LEVEL OF EVIDENCE: Prognostic and epidemiologic study, II.

Nurse and physician agreement in the assessment of minor blunt head trauma.

OBJECTIVE: The Pediatric Emergency Care Applied Research Network (PECARN) traumatic brain injury (TBI) clinical prediction rules identify children with minor blunt head trauma who are at low risk for clinically important traumatic brain injuries. We measured the agreement between the registered nurse (RN) and physician (MD) assessments. METHODS: We performed a cross-sectional study of all children <18 years of age with minor blunt head trauma who presented to a single emergency department. RNs and MDs independently assessed each child and recorded age-based PECARN predictors. As symptoms can change over time, we included cases only when both evaluations were completed within 60 minutes. We used the κ statistic to measure RN-MD agreement, with the main analysis focusing on the overall PECARN rule agreement. RESULTS: Of the 1624 eligible children, 1191 (73%) had evaluations completed by both RN and ED providers, of which 437 (37%) were in children <2 years of age. The median time between completions of the provider forms was 12 minutes (interquartile range 4-25 minutes). The overall agreement between the RN and MD was higher for the older children (κ 0.55, 95% confidence interval 0.49-0.61 for children 2-18 years versus κ 0.32, 95% confidence interval 0.23-0.41 for children <2 years). CONCLUSIONS: The overall agreement between RN and MD for the PECARN TBI prediction rules was moderate for older children and fair for younger children. Initial RN assessments should be verified by the MD before clinical application, especially for the youngest children.

Variation in resource utilization across a national sample of pediatric emergency departments.

OBJECTIVE: To describe variations in emergency department (ED) quality measures and determine the association between ED costs and outcomes for 3 pediatric conditions: asthma, gastroenteritis, and simple febrile seizure. STUDY DESIGN: This cross-sectional analysis of ED visits used the Pediatric Health Information System database. Children aged ≤ 18 years who were evaluated in an ED between July 2009 and June 2011 and had a discharge diagnosis of asthma, gastroenteritis, or simple febrile seizure were included. Two quality of care metrics were evaluated for each target condition, and Spearman correlation was applied to evaluate the relationship between ED costs (reflecting overall resource utilization) and admission and revisit rates among institutions. RESULTS: More than 250,000 ED visits at 21 member hospitals were analyzed. Among children with asthma, the median rate of chest radiography utilization was 35.1% (IQR, 31.3%-41.7%), and that of corticosteroid administration was 82.6% (IQR, 78.5%-86.5%). For children with gastroenteritis, the median rate of ondansetron administration was 52% (IQR, 43.2%-57.0%), and that of intravenous fluid administration was 18.1% (IQR, 15.3%-21.3%). Among children with febrile seizures, the median rate of computed tomography utilization was 3.1% (IQR, 2.7%-4.3%), and that of lumbar puncture was 4.0% (IQR, 2.3%-5.6%). Increased costs were not associated with lower admission rate or 3-day ED revisit rate for the 3 conditions. CONCLUSION: We observed variation in quality measures for patients presenting to pediatric EDs with common conditions. Higher costs were not associated with lower hospitalization or ED revisit rates.

Interobserver agreement in the assessment of clinical findings in children with first unprovoked seizures.

OBJECTIVES: Variables used in prediction rules and clinical guidelines should show acceptable agreement when assessed by different observers. Our objective was to determine the interobserver agreement of patient history and physical examination variables used to assess children undergoing emergency department (ED) evaluation for a first seizure not provoked by a known precipitant such as fever or trauma (ie, an unprovoked seizure). METHODS: We conducted a prospective cohort study of children aged 28 days to 18 years evaluated for unprovoked seizures at 6 tertiary care EDs. We excluded patients if previously evaluated for a similar event. Two clinicians independently completed a clinical assessment before neuroimaging. We determined agreement for each clinical variable by using the unweighted κ statistic. RESULTS: A total of 217 paired observations were analyzed; median patient age was 53.5 months, and 38% were younger than 2 years. Agreement beyond chance was at least moderate (κ ≥ 0.41) for 21 of 31 (68%) variables for which κ could be calculated. κ was ≥0.41 for 7 of 11 (64%) general history variables, all 8 seizure-specific history variables (including seizure focality), and 6 of 12 (50%) physical examination variables. Agreement beyond chance was substantial or better (κ ≥ 0.61) for 2 of 11 (18%) general history variables, for 5 of 8 (63%) seizure-specific history variables, and for 2 of 12 (17%) physical examination variables. CONCLUSIONS: For children with first unprovoked seizures evaluated in the ED, clinicians frequently assess findings from seizure-specific history with substantial agreement beyond chance. Those clinical variables that have been associated with the presence of intracranial abnormalities and show reliability between assessors, such as seizure focality and the presence of any focal neurological finding, may be more useful in the ED assessment of children with first unprovoked seizures.

Do workshops in evidence-based practice equip participants to identify and answer questions requiring consideration of clinical research? A diagnostic skill assessment.

Evidence-based practice (EBP) requires practitioners to identify and formulate questions in response to patient encounters, and to seek, select, and appraise applicable clinical research. A standardized workshop format serves as the model for training of medical educators in these skills. We developed an evaluation exercise to assess the ability to identify and solve a problem requiring the use of targeted skills and administered it to 47 North American junior faculty and residents in various specialties at the close of two short workshops in EBP. Prior to the workshop, subjects reported prior training in EBP and completed a previously validated knowledge test. Our post-workshop exercise differed from the baseline measures and required participants to spontaneously identify a suitable question in response to a simulated clinical encounter, followed by a description of a stepwise approach to answering it. They then responded to successively more explicitly prompted queries relevant to their question. We analyzed responses to identify areas of skill deficiency and potential reasons for these deficiencies. Twelve respondents (26%) initially failed to identify a suitable question in response to the clinical scenario. Ability to choose a suitable question correlated with the ability to connect an original question to an appropriate study design. Prior EBP training correlated with the pretest score but not with performance on our exercise. Overall performance correlated with ability to correctly classify their questions as pertaining to therapy, diagnosis, prognosis, or harm. We conclude that faculty and residents completing standard workshops in EBP may still lack the ability to initiate and investigate original clinical inquiries using EBP skills.

Interobserver agreement in assessment of clinical variables in children with blunt head trauma.

OBJECTIVES: To be useful in development of clinical decision rules, clinical variables must demonstrate acceptable agreement when assessed by different observers. The objective was to determine the interobserver agreement in the assessment of historical and physical examination findings of children undergoing emergency department (ED) evaluation for blunt head trauma. METHODS: This was a prospective cohort study of children younger than 18 years evaluated for blunt head trauma at one of 25 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). Patients were excluded if injury occurred more than 24 hours prior to evaluation, if neuroimaging was obtained at another hospital prior to evaluation, or if the patient had a clinically trivial mechanism of injury. Two clinicians independently completed a standardized clinical assessment on a templated data form. Assessments were performed within 60 minutes of each other and prior to clinician review of any neuroimaging (if obtained). Agreement between the two observers beyond that expected by chance was calculated for each clinical variable, using the kappa (kappa) statistic for categorical variables and weighted kappa for ordinal variables. Variables with a lower 95% confidence limit (LCL) of kappa > 0.4 were considered to have acceptable agreement, RESULTS: Fifteen-hundred pairs of observations were obtained. Acceptable agreement was achieved in 27 of the 32 variables studied (84%). Mechanism of injury (low, medium, or high risk) had kappa = 0.83. For subjective symptoms, kappa ranged from 0.47 (dizziness) to 0.93 (frequency of vomiting); all had 95% LCL > 0.4. Of the physical examination findings, kappa ranged from 0.22 (agitated) to 0.89 (Glasgow Coma Scale [GCS] score). The 95% LCL for kappa was < 0.4 for four individual signs of altered mental status and for quality (i.e., boggy or firm) of scalp hematoma if present. CONCLUSIONS: Both subjective and objective clinical variables in children with blunt head trauma can be assessed by different observers with acceptable agreement, making these variables suitable candidates for clinical decision rules.