A significant number of disaster and emergency victims are children. Yet, many hospitals are ill-prepared to care for these patients during disasters, as identified by the National Pediatric Readiness Project’s survey of hospital pediatric disaster plans. The Region V for Kids Center of Excellence created a self-assessment tool to help regions identify vulnerabilities and ways to enhance care for vulnerable children and families.

Region V for Kids identified 9 key domains (eg, infrastructures and support mechanisms) that are important to safeguard children’s and families’ care during disasters. A self-assessment tool to assess these domains was distributed to 24 regional health care coalitions along with a 9-question usefulness survey. The self-assessment tool addressed 3 of the original domains, which have regional or national open-source databases and datapoints that health care coalitions can access for their responses.

The survey received a 50% response rate. Approximately 40% of respondents indicated they were “somewhat likely” to make changes based on data gathered by the tool. The original self-assessment tool was revised to create an expanded web-based version.

Health care coalitions and localities can use this tool to evaluate pediatric preparedness, identify needed improvements, and improve outcomes for children, families, and communities.

The coronavirus disease (COVID-19) pandemic produced swift, extensive changes in daily life, including for first-episode psychosis (FEP) clients. This study examined pandemic-related psychosocial impacts to clients while engaged in Coordinated Specialty Care (CSC). We also examined FEP client vaccination rates, as vaccinations can reduce hospitalizations/deaths, and related worries.

Thirty-one clients (45% female; ages 13-39; 26% black, 61% white) from Pennsylvania (PA) CSC outpatient programs completed an online survey evaluating exposure to COVID-19, associated worries, coping, and safety strategies. Descriptive statistics characterized responses and demographic group differences. Additional program evaluation data informed vaccination rates for PA FEP clients.

Participants reported substantial pandemic-related impacts to daily life. Many clients reported improved safety measures to protect themselves/others from COVID-19. Clients largely denied substantial worries about infection for themselves, reporting greater concern for loved ones. Multiple coping strategies were endorsed, which, with few exceptions, did not differ among demographic groups. FEP clients had a low reported rate of vaccination (28.6%) as of September 2021.

Observed prolonged pandemic effects may alter FEP client progress in CSC. Stakeholders should be prepared to adjust FEP treatment accordingly in the event of a similar disaster. Concentrated vaccination efforts may be necessary for this population.

To explore the health impacts of Hurricane Maria (HM) on HIV care outcomes among people living with HIV who use drugs.

Using data from an ongoing cohort study in San Juan, Puerto Rico (Proyecto PACTo), we measured differences in HIV care outcomes (viral load, viral suppression, and CD4 counts) before and after HM using assessments conducted at 6-month intervals. Generalized estimating equations were used to assess factors associated with HIV care outcomes.

All HIV care outcomes showed a deterioration from pre-HM values to post-HM values (mean viral load increased, CD4 counts decreased, and rate of viral suppression decreased) after controlling for pre-HM sociodemographic and health characteristics. In addition to HM, age (aIRR = 1·01), being homeless (aIRR = 0·78) and having health insurance (aIRR = 1·6) were independently associated with viral suppression.

219 participants completed follow-up visits between April 2017 and January 2018, before and after HM.

People living with HIV who use drugs in Puerto Rico experienced poorer HIV outcomes following HM. Socio-environmental factors contributing to these outcomes is discussed in the context of disaster response, recovery, and program planning.

Previous studies have demonstrated the use of virtual reality (VR) in mass-casualty incident (MCI) simulation; however, it is uncertain if VR simulations can be a substitute for in-person disaster training. Demonstrating that VR MCI scenarios can elicit the same desired stress response achieved in live-action exercises is a first step in showing non-inferiority. The primary objective of this study was to measure changes in sympathetic nervous system (SNS) response via a decrease in heart rate variability (HRV) in subjects participating in a VR MCI scenario.

An MCI simulation was filmed with a 360º camera and shown to participants on a VR headset while simultaneously recording electrocardiography (EKG) and HRV activity. Baseline HRV was measured during a calm VR scenario immediately prior to exposure to the MCI scenarios, and SNS activation was captured as a decrease in HRV compared to baseline. Cognitive stress was measured using a validated questionnaire. Wilcoxon matched pairs signed rank analysis, Welch’s t-test, and multivariate logistic regression were performed with statistical significance established at P <.05.

Thirty-five subjects were enrolled: eight attending physicians (two surgeons, six Emergency Medicine [EM] specialists); 13 residents (five Surgery, eight EM); and 14 medical students (six pre-clinical, eight clinical-year students). Sympathetic nervous system activation was observed in all groups during the MCI compared to baseline (P <.0001) and occurred independent of age, sex, years of experience, or prior MCI response experience. Overall, 23/35 subjects (65.7%) reported increased cognitive stress in the MCI (11/14 medical students, 9/13 residents, and 3/8 attendings). Resident and attending physicians had higher odds of discordance between SNS activation and cognitive stress compared to medical students (OR = 8.297; 95% CI, 1.408-64.60; P = .030).

Live-actor VR MCI simulation elicited a strong sympathetic response across all groups. Thus, VR MCI training has the potential to guide acquisition of confidence in disaster response.

The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19.

Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020

Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies.

This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic

To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.

Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.

Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.

Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.

We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.

Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran’s Administration purview and specific staff in charge of a protocol's review.

We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

Hurricane Sandy forced closures of many free-standing dialysis centers in New York City in 2012. Hemodialysis (HD) patients therefore sought dialysis treatments from nearby hospitals. The surge capacity of hospital dialysis services was the rate-limiting step for streamlining the emergency department flow of HD patients. The aim of this study was to determine the extent of the HD patients surge and to explore difficulties encountered by hospitals in Brooklyn, New York (USA) due to Hurricane Sandy.

A retrospective survey on hospital dialysis services was conducted by interviewing dialysis unit managers, focusing on the influx of HD patients from closed dialysis centers to hospitals, coping strategies these hospitals used, and difficulties encountered.

In total, 347 HD patients presented to 15 Brooklyn hospitals for dialysis. The number of transient HD patients peaked two days after landfall and gradually decreased over a week. Hospital dialysis services reported issues with lack of dialysis documentation from transient dialysis patients (92.3%), staff shortage (50%), staff transportation (71.4%), and communication with other agencies (53.3%). Linear regression showed that factors significantly associated with enhanced surge capacity were the size of inpatient dialysis unit (P = .040), having affiliated outpatient dialysis centers (P = .032), using extra dialysis machines (P = .014), and having extra workforce (P = .007). Early emergency plan activation (P = .289) and shortening treatment time (P = .118) did not impact the surge capacity significantly in this study.

These findings provide potential improvement options for receiving hospitals dialysis units to prepare for future events.

LinC, PierceLC, RoblinPM, ArquillaB. Impact of Hurricane Sandy on Hospital Emergency and Dialysis Services: A Retrospective Survey. Prehosp Disaster Med. 2014;29(4):1-6.

The aim of this study was to determine if a relationship exists between the development of adaptive capacity and disaster response and recovery outcomes. Hospitals and health care systems are a critical element in community planning for all phases of the disaster cycle. There is a lack of research, however, to validate the relationship between the development of these capabilities and improved response and recovery outcomes.

Two hypotheses were formulated to address the research question. The first hypothesis argued that counties or parishes that developed adaptive capacity through pre-event planning, community engagement, training, and the use of national response frameworks would have improved response and recovery performance outcomes. The second hypothesis argued that adaptive capacity, along with response and recovery performance outcomes, predicts the trajectory of recovery progression.

This study employed a quantitative cross-sectional survey methodology and existing community demographic data to explore the development of adaptive capacity and its ability to predict disaster response and recovery outcomes in communities affected by major disaster in 2011. A total of 333 counties and parishes were included in the final sample, providing a 95% confidence interval with a 5% margin of error. Data were analyzed using both descriptive and inferential statistics. Multiple, hierarchical, and robust regression were used to find the best fitting model. Multi-level modeling with random intercepts was used to control for the nesting effects associated with county, state, and the Federal Emergency Management Agency (FEMA) region sampling.

Descriptive results provide a baseline assessment of adaptive capacity development at the community level. While controlling for other variables, hypothesis testing revealed that pre-event planning, community engagement, full-scale exercises, and use of national frameworks predicated overall response and recovery performance outcomes (R 2 = .43; F13,303 = 13.34; P < .001). In terms of recovery progression, pre-event planning, overall response and recovery performance outcome, total time of disruption, and percent of people below poverty were significant (R2 = .15; F14,302 = 4.53; P < .001).

Establishment of empirical data provides communities with reinforcement to continue resilience-building activities at the local level. However, findings from this study suggest that only full-scale exercises were significant in improving response and recovery outcomes. Implications for re-evaluation of disaster training warrant further exploration.

ZukowskiRS . The Impact of Adaptive Capacity on Disaster Response and Recovery: Evidence Supporting Core Community Capabilities. Prehosp Disaster Med. 2014;29(4):1-8.

Prehospital postresuscitation induced hypothermia (IH) has been shown to reduce neurological complications in comatose cardiac-arrest survivors. Retrofitting ambulances to include equipment appropriate to initiate hypothermia, such as refrigeration units for cooled saline, is expensive. The objective of this nonhuman subject research study was to determine if inexpensive, commercially available coolers could, in conjunction with five reusable ice packs, keep two 1 L bags of precooled 0.9% normal saline solution (NSS) at or below 4°C for an average shift of eight to 12 hours in a real-world environment, on board in-service Emergency Medical Service (EMS) units, over varying weather conditions in all seasons.

The coolers were chosen based on availability and affordability from two nationally available brands: The Igloo MaxxCold (Igloo Products Corp., Katy, Texas USA) and Coleman (The Coleman Company, Wichita, Kansas USA). Both are 8.5 liter (nine-quart) coolers that were chosen because they adequately held two 1 L bags of saline solution, along with the reusable ice packs designated in the study design, and were small enough for ease of placement on ambulances. Initial testing of the coolers was conducted in a controlled environment. Thereafter, each EMS unit was responsible to cool the saline to less than 4°C prior to shift. Data were collected by emergency medical technicians, paramedics, and resident physicians working in seven different ambulance squads. Data analysis was performed using repeated measurements recorded over a 12-hour period from 19 individual coolers and were summarized by individual time points using descriptive statistics.

Initial testing determined that the coolers maintained temperatures of 4°C for 12 hours in a controlled environment. On the ambulances, results based on the repeated measurements over time revealed that the saline solution samples as defined in the protocol, remained consistently below 4°C for 12 hours. Utilizing the lower bound of the 2-sided 95% exact binomial confidence intervals, there was less than a five percent chance that saline samples could not be maintained below 4°C for 12 hours, even during the summer months.

Simple, commercially available coolers can maintain two 1 L bags of 0.9% NSS at 4°C for 12 hours in ambulances in varying environmental conditions. This suggests that EMS agencies could inexpensively initiate prehospital IH in appropriate cases.

KaneKE , TomshoRJ , PheasantK , StaufferT , SchoenfeldtB , HamiltonS , KainT , KaneBG . The “ICE” Study: Feasibility of Inexpensive Commercial Coolers on Mobile EMS Units. Prehosp Disaster Med. 2014;29(3):1-8.