Practical Guide to Pragmatic Clinical Trials in Surgical Education Research.

This Guide to Statistics and Methods provides an overview of the key features of pragmatic trials within the context of surgical education research using examples from the Flexibility in Duty-Hour Requirements for Surgical Trainees trial.

Practical Guide to Education Program Evaluation Research.

This Guide to Statistics and Methods describes common methods for building evidence of validity for a program within health professional education and provides a framework for program evaluation.

Practical Guide to Survey Research in Surgical Education.

This Guide to Statistics and Methods describes aspects of methods of survey research in surgical education, important considerations, and pitfalls and limitations.

Development of a clinical prediction instrument to estimate risk of initial violent injury.

BACKGROUND: Interpersonal violent injury is a public health crisis, disproportionately affecting young people of color. We aimed to evaluate associations between sociobehavioral predictors and first-time violent injury, and to develop a predictive risk score for violent injury. METHODS: We performed a retrospective case-cohort study of adolescents aged 12-18 years. Multivariable logistic regression was used to estimate associations between 35 candidate variables and interpersonal first-time violent injury resulting in an emergency department (ED) visit. Multiple imputation was used to account for missing values and a risk score was developed by multiplying regression coefficients by 10 to generate a composite tool to predict initial violent injury (IVI). Discrimination and calibration were assessed using 10-fold cross validation. RESULTS: 19,210 adolescents were included, 276 (1.4%) as victims of IVI. The final model, the Initial Violent Injury Risk Prediction Tool (IVI-RPT), included: age, fight within the prior year, trouble with the law, and alcohol use. IVI-RPT scores were categorized as: 0-7 (low risk), 8-16 (moderate), and 17-26 (high), and IVI prevalence was 0.8% (95% confidence interval [CI]: 0.6%, 0.9%), 2.5% (95% CI: 1.9%, 3.1%), and 5.3% (95% CI: 4.1%, 6.6%), respectively. The area under the receiver operating characteristic curve was 0.70 (95% CI: 0.66, 0.73), while the slope of the calibration curve was 1.1 (95% CI: 0.9, 1.2). CONCLUSIONS: We developed a promising clinical prediction instrument, the IVI-RPT, that categorizes individuals into risk groups with increasing probabilities of violent injury. External validation of this tool is required prior to clinical practice implementation.

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.

BACKGROUND: Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial. METHODS: The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV. DISCUSSION: When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04003454 . Registered on 1 July 2019.

Temporal associations between emergency department and telehealth volumes during the COVID-19 pandemic: A time-series analysis from 2 academic medical centers.

BACKGROUND: The COVID-19 pandemic compelled healthcare systems to rapidly adapt to changing healthcare needs as well as identify ways to reduce COVID transmission. The relationship between pandemic-related trends in emergency department (ED) visits and telehealth urgent care visits have not been studied. METHODS: We performed an interrupted time series analysis to evaluate trends between ED visits and telehealth urgent medical care visits at two urban healthcare system in Colorado. We performed pairwise comparisons between baseline versus each COVID-19 surge and all three surges combined, for both ED and telehealth encounters at each site and used Wilcoxon rank sum test to compare median values. RESULTS: During the study period, 595,350 patient encounters occurred. We saw ED visits decline in correlation with rising telehealth visits during each COVID surge. CONCLUSIONS: During initial COVID surges, ED visits declined while telehealth visits rose in inverse correlation with falling ED visits, suggesting that some patients shifted their preferred location for clinical care. As EDs cope with future staffing during the ongoing COVID pandemic, telehealth represents an opportunity for emergency physicians and a means to align patients desires for virtual care with ED volumes and staffing.

Development of a 2-step algorithm to identify emergency department patients for HIV pre-exposure prophylaxis.

BACKGROUND: Expanded access to HIV PrEP is a central pillar of the "Ending the HIV Epidemic" initiative. Identification of PrEP eligible individuals in EDs remains understudied. Our goal was to estimate the accuracy of the Denver HIV Risk Score (DHRS), a quantitative HIV risk tool, for determining PrEP eligibility, and to incorporate it into a novel screening algorithm to optimize sensitivity and specificity. METHODS: We performed a prospective cross-sectional study in two urban EDs. Patients were eligible if ≥18 years of age and without HIV. Research staff collected individual HIV risk, components of the DHRS, and PrEP eligibility per 2017 CDC guidelines. Accuracy estimates were calculated for the DHRS alone and the DHRS plus additional PrEP-specific questions. RESULTS: 1002 patients were enrolled with a median age of 39 years; 54.8% were male, 29.5% Black/non-Hispanic, and 22.5% Hispanic. Overall, 119 (11.9%, 95% CI: 9.9%-14.0%) were PrEP eligible; 5% endorsed history of sex with a partner at higher risk for HIV or condomless sex with multiple partners, 4% an STI, and 2% sharing IDU equipment. A DHRS ≥25 had a sensitivity of 92.4% (95% CI: 86.1%-96.5%) and a specificity of 17.2% (95% CI: 14.8%-19.9%) for PrEP eligibility. A 2-step algorithm, "DHRS-PrEP", beginning with a DHRS ≥25, followed by a step with questions specific to IDU, STI, and sexual partners improved the specificity to 100% (95% CI: 99.6%-100%). CONCLUSIONS: Among a heterogeneous ED sample, a substantial proportion was identified as PrEP eligible, and a 2-step algorithm had high sensitivity and specificity for identifying PrEP-eligible patients.

Video Laryngoscopy Is Associated With First-Pass Success in Emergency Department Intubations for Trauma Patients: A Propensity Score Matched Analysis of the National Emergency Airway Registry.

STUDY OBJECTIVE: We sought to (1) characterize emergency department (ED) intubations in trauma patients and estimate (2) first-pass success and (3) the association between patient and intubation characteristics and first-pass success. METHODS: We performed a secondary analysis of a multicenter prospective observational cohort of ED intubations from the National Emergency Airway Registry (NEAR). Descriptive statistics were calculated for all patients who were intubated for trauma at 23 NEAR EDs between 2016 and 2018. We evaluated first-pass success in patients intubated by (1) emergency or pediatric emergency physicians, (2) using rapid sequence intubation or no medications, and (3) either direct laryngoscopy or video laryngoscopy. We used propensity score matching with a generalized linear mixed-effects model to estimate the associations between patient and intubation characteristics and first-pass success. RESULTS: Of the 19,071 intubations in NEAR, 4,449 (23%) were for trauma, and nearly all (88%) had at least one difficult airway characteristic. Prevalence of first-pass success was 86.8% (95% confidence interval [CI]: 83.3% to 90.3%). Most patients were intubated with video laryngoscopy, and patients were more likely to be intubated on first-pass with video laryngoscopy as compared to direct laryngoscopy (90% versus 79%). After propensity score matching, video laryngoscopy remained associated with first-pass success (adjusted risk difference 11%, 95% CI: 8% to 14%; and OR 2.2, 95% CI: 1.6 to 2.9). Additionally, an initial impression of difficult airway, blood/vomit in the airway, and use of external laryngeal manipulation were all associated with decreased odds of first-pass success. CONCLUSION: Emergency physicians are successful at intubating patients in the setting of trauma, and video laryngoscopy is associated with twice the odds of first-pass success when compared to direct laryngoscopy.

Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial.

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown. Objective: To compare strategies for HIV screening when integrated into usual ED practice. Design, Setting, and Participants: This randomized clinical trial included patients visiting EDs at 4 US urban hospitals between April 2014 and January 2016. Patients included were ages 16 years or older, not critically ill or mentally altered, not known to have an HIV positive status, and with an anticipated length of stay 30 minutes or longer. Data were analyzed through March 2021. Interventions: Consecutive patients underwent concealed randomization to either nontargeted screening, enhanced targeted screening using a quantitative HIV risk prediction tool, or traditional targeted screening as adapted from the Centers for Disease Control and Prevention. Screening was integrated into clinical practice using opt-out consent and fourth-generation antigen-antibody assays. Main Outcomes and Measures: New HIV diagnoses using intention-to-treat analysis, absolute differences, and risk ratios (RRs). Results: A total of 76 561 patient visits were randomized; median (interquartile range) age was 40 (28-54) years, 34 807 patients (51.2%) were women, and 26 776 (39.4%) were Black, 22 131 (32.6%) non-Hispanic White, and 14 542 (21.4%) Hispanic. A total of 25 469 were randomized to nontargeted screening; 25 453, enhanced targeted screening; and 25 639, traditional targeted screening. Of the nontargeted group, 6744 participants (26.5%) completed testing and 10 (0.15%) were newly diagnosed; of the enhanced targeted group, 13 883 participants (54.5%) met risk criteria, 4488 (32.3%) completed testing, and 7 (0.16%) were newly diagnosed; and of the traditional targeted group, 7099 participants (27.7%) met risk criteria, 3173 (44.7%) completed testing, and 7 (0.22%) were newly diagnosed. When compared with nontargeted screening, targeted strategies were not associated with a higher rate of new diagnoses (enhanced targeted and traditional targeted combined: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.7; 95% CI, 0.30 to 1.56; P = .38; and enhanced targeted only: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.70; 95% CI, 0.27 to 1.84; P = .47). Conclusions and Relevance: Targeted HIV screening was not superior to nontargeted HIV screening in the ED. Nontargeted screening resulted in significantly more tests performed, although all strategies identified relatively low numbers of new HIV diagnoses. Trial Registration: ClinicalTrials.gov Identifier: NCT01781949.

Ultrasound Hypotension Protocol Time-motion Study Using the Multifrequency Single Transducer Versus a Multiple Transducer Ultrasound Device.

INTRODUCTION: Ultrasound hypotension protocols (UHP) involve imaging multiple body areas, each with different transducers and imaging presets. The time for task switching between presets and transducers to perform an UHP has not been previously studied. A novel hand-carried ultrasound (HCU) has been developed that uses a multifrequency single transducer to image areas of the body (lung, heart, abdomen, superficial) that would typically require three transducers using a traditional cart-based ultrasound (CBU) system. Our primary aim was to compare the time to complete UHPs with a single transducer HCU to a multiple transducer CBU. METHODS: We performed a randomized, crossover feasibility trial in the emergency department of an urban, safety-net hospital. This was a convenience sample of non-hypotensive emergency department patients presenting during a two-month period of time. Ultrasound hypotension protocols were performed by emergency physicians (EP) on patients using the HCU and the CBU. The EPs collected UHP views in sequential order using the most appropriate transducer and preset for the area/organ to be imaged. Time to complete each view, time for task switching, total time to complete the examination, and image diagnostic quality were recorded. RESULTS: A total of 29 patients were scanned by one of eight EPs. When comparing the HCU to the CBU, the median time to complete the UHP was 4.3 vs 8.5 minutes (P <0.0001), respectively. When the transport and plugin times were excluded, the median times were 4.1 vs 5.8 minutes (P <0.0001), respectively. There was no difference in the diagnostic quality of images obtained by the two devices. CONCLUSION: Ultrasound hypotension protocols were performed significantly faster using the single transducer HCU compared to a multiple transducer CBU with no difference in the number of images deemed to be diagnostic quality.

COVID-19 and beyond: Lessons learned from emergency department HIV screening for population-based screening in healthcare settings.

Emergency departments (EDs) have played a major role in the science and practice of HIV population screening. After decades of experience, EDs have demonstrated the capacity to provide testing and linkage to care to large volumes of patients, particularly those who do not otherwise engage the healthcare system. Efforts to expand ED HIV screening in the United States have been accelerated by a collaborative national network of emergency physicians and other stakeholders called EMTIDE (Emergency Medicine Transmissible Infectious Diseases and Epidemics). As the COVID-19 pandemic evolves, EDs nationwide are being tasked with diagnosing and managing COVID-19 in a myriad of capacities, adopting varied approaches based in part on know-how, local disease trends, and the supply chain. The objective of this article is to broadly summarize the lessons learned from decades of ED HIV screening and provide guidance for many analogous issues and challenges in population screening for COVID-19. Over time, and with the accumulated experience from other epidemics, ED screening should develop into an overarching discipline in which the disease in question may vary, but the efficiency of response is increased by prior knowledge and understanding.

HIV Risk and Pre-Exposure Prophylaxis Eligibility Among Emergency Department Patients.

Our objective was to estimate the prevalence of pre-exposure prophylaxis (PrEP) eligibility, characterize self-perceived and quantified human immunodeficiency virus (HIV) risk, and assess PrEP knowledge and receptiveness of initiating PrEP among emergency department (ED) patients. We performed an IRB-approved cross-sectional study from two urban EDs. Patients were eligible if ≥18 years of age and not known to have HIV. Research staff obtained verbal consent and used a structured 29-item instrument to assess HIV risk, PrEP eligibility based on 2017 Centers for Disease Control and Prevention (CDC) guidelines, and general PrEP knowledge among unselected and enriched patient samples, the latter informed by the Denver HIV Risk Score (DHRS). We enrolled 1002 patients with a median age of 39 years; 54.8% were male, 30.9% White/non-Hispanic, 29.5% Black/non-Hispanic, and 22.5% Hispanic. In the full cohort, 119 [11.9%, 95% confidence interval (CI): 9.9-14.0%] were PrEP eligible, and among the unselected cohort, 36 (7.1%, 95% CI: 5.1-9.8%) were PrEP eligible. Using the DHRS, 100 patients were considered "high risk" with 32 (32.0%) reporting zero perceived risk. Correlation between the DHRS and self-perceived HIV risk was low (r = 0.13). Of the full cohort, 203 (20.3%) had heard of PrEP, and of these, 33 (16.3%) were PrEP eligible with 25 (75.8%) willing to start PrEP immediately. Yet, of the 119 patients who were PrEP eligible, only 34 (28.6%) had heard of PrEP. In summary, among a heterogeneous ED population, there was discordance in self-perceived and quantified HIV risk. HIV PrEP eligibility was ∼7% with the highest eligibility among those identified as DHRS "high risk." A significant opportunity exists to identify and initiate PrEP among ED patients.