Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

BACKGROUND: Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals. METHODS: We evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively. We conducted biweekly or monthly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination. FINDINGS: Among 17 outcomes evaluated, 15 did not meet the threshold for statistical signal in any of the three databases. Myocarditis/pericarditis met the statistical threshold for a signal following BNT162b2 in two of three databases (RRs: 1.83-2.47). Anaphylaxis met the statistical threshold for a signal in all three databases following BNT162b2 vaccination (RRs: 4.48-10.86) and mRNA-1273 vaccination (RRs: 7.64-12.40). DISCUSSION: Consistent with published literature, our near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method is intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method's utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies.

The views and experiences of Zambia's emergency medicine registrars in South Africa: Lessons for the development of emergency care in Zambia.

INTRODUCTION: Although low- and middle-income countries (LMICs) are beginning to integrate emergency medicine (EM) specialist physicians into their healthcare systems, they must often send these trainees to other countries with established registrar programmes. Given that retention of foreign-trained EM specialist physicians is low following repatriation, there is interest in understanding their expectations and intentions when they return. This study aimed to describe the expectations of Zambia's EM registrars regarding the development of various aspects of emergency care in Zambia. METHODS: In this qualitative, descriptive study, individual telephonic interviews were conducted with current Zambian EM registrars using a semi-structured interview schedule. Recorded interviews were transcribed verbatim, validated by participants, and subjected to inductive content analysis. RESULTS: Four interviews were completed, representing the entire population of interest. Two key categories emerged from these discussions: that the state of emergency care in Zambia was inadequate, and that there were numerous priority areas for further developing the emergency care system. A lack of recognition of EM as a specialty, resource and training constraints in emergency units, and the lack of a formal prehospital emergency care system were prominently identified as challenges. Priority aspects that registrars hoped to focus on when developing emergency care included expanding local training and knowledge, improving the supply chain for essential medications and equipment, increasing interprofessional collaborative practice, and advocating for emergency care. CONCLUSION: Zambian EM registrars characterised the nascent emergency care system by challenges that are common in many LMICs and align with previous in-country assessments of emergency care. In order to ensure that registrars' strategies are ultimately implemented upon their return to Zambia, it is imperative they are communicated with stakeholders in-country. From there, mutual planning can occur between future EM specialists and government stakeholders, to ensure that there are mechanisms in place to facilitate dissemination.

Validity and reliability of the South African Triage Scale in prehospital providers.

BACKGROUND: The South African Triage Scale (SATS) is a validated in-hospital triage tool that has been innovatively adopted for use in the prehospital setting by Western Cape Government (WCG) Emergency Medical Services (EMS) in South Africa. The performance of SATS by EMS providers has not been formally assessed. The study sought to assess the validity and reliability of SATS when used by WCG EMS prehospital providers for single-patient triage. METHODS: This is a prospective, assessment-based validation study among WCG EMS providers from March to September 2017 in Cape Town, South Africa. Participants completed an assessment containing 50 clinical vignettes by calculating the three components - triage early warning score (TEWS), discriminators (pre-defined clinical conditions), and a final SATS triage color. Responses were scored against gold standard answers. Validity was assessed by calculating over- and under-triage rates compared to gold standard. Inter-rater reliability was assessed by calculating agreement among EMS providers' responses. RESULTS: A total of 102 EMS providers completed the assessment. The final SATS triage color was accurately determined in 56.5%, under-triaged in 29.5%, and over-triaged in 13.1% of vignette responses. TEWS was calculated correctly in 42.6% of vignettes, under-calculated in 45.0% and over-calculated in 10.9%. Discriminators were correctly identified in only 58.8% of vignettes. There was substantial inter-rater and gold standard agreement for both the TEWS component and final SATS color, but there was lower inter-rater agreement for clinical discriminators. CONCLUSION: This is the first assessment of SATS as used by EMS providers for prehospital triage. We found that SATS generally under-performed as a triage tool, mainly due to the clinical discriminators. We found good inter-rater reliability, but poor validity. The under-triage rate of 30% was higher than previous reports from the in-hospital setting. The over-triage rate of 13% was acceptable. Further clinically-based and qualitative studies are needed. TRIAL REGISTRATION: Not applicable.

Pragmatic Recommendations for Identification and Triage of Patients with COVID-19 in Low- and Middle-Income Countries.

Effective identification and prognostication of severe COVID-19 patients presenting to healthcare facilities are essential to reducing morbidity and mortality. Low- and middle-income country (LMIC) facilities often suffer from restrictions in availability of human resources, laboratory testing, medications, and imaging during routine functioning, and such shortages may worsen during times of surge. Low- and middle-income country healthcare providers will need contextually appropriate tools to identify and triage potential COVID-19 patients. We report on a series of LMIC-appropriate recommendations and suggestions for screening and triage of COVID-19 patients in LMICs, based on a pragmatic, experience-based appraisal of existing literature. We recommend that all patients be screened upon first contact with the healthcare system using a locally approved questionnaire to identify individuals who have suspected or confirmed COVID-19. We suggest that primary screening tools used to identify individuals who have suspected or confirmed COVID-19 include a broad range of signs and symptoms based on standard case definitions of COVID-19 disease. We recommend that screening include endemic febrile illness per routine protocols upon presentation to a healthcare facility. We recommend that, following screening and implementation of appropriate universal source control measures, suspected COVID-19 patients be triaged with a triage tool appropriate for the setting. We recommend a standardized severity score based on the WHO COVID-19 disease definitions be assigned to all suspected and confirmed COVID-19 patients before their disposition from the emergency unit. We suggest against using diagnostic imaging to improve triage of reverse transcriptase (RT)-PCR-confirmed COVID-19 patients, unless a patient has worsening respiratory status. We suggest against the use of point-of-care lung ultrasound to improve triage of RT-PCR-confirmed COVID-19 patients. We suggest the use of diagnostic imaging to improve sensitivity of appropriate triage in suspected COVID-19 patients who are RT-PCR negative but have moderate to severe symptoms and are suspected of a false-negative RT-PCR with high risk of disease progression. We suggest the use of diagnostic imaging to improve sensitivity of appropriate triage in suspected COVID-19 patients with moderate or severe clinical features who are without access to RT-PCR testing for SARS-CoV-2.

Dispatcher Triage Accuracy in the Western Cape Government Emergency Medical Services System, Cape Town, South Africa.

INTRODUCTION: Triage - the sorting of patients according to urgency of need for clinical care - is an essential part of delivering effective and efficient emergency care. But when frequent over- or under-triaging occurs, finite time and resources are diverted away from those in greatest need of care and the entire Emergency Medical Services (EMS) system is strained. In resource-constrained settings, such as South Africa, poor triage in EMS only serves to compound other contextual challenges. This study examined the accuracy of dispatcher triage over a one-year period in the Western Cape Government (WCG) EMS system in South Africa. METHODS: A retrospective analysis of existing dispatch and EMS data to assess the accuracy of dispatch-assigned priorities was conducted. The mismatch between dispatcher-assigned call priority and triage levels determined by EMS personnel was analyzed via over- and under-triage rates, sensitivity and specificity, and positive and negative predictive values (PPVs and NPVs, respectively). RESULTS: A total of 185,166 records from December 2016 through November 2017 were analyzed. Across all dispatch complaints, the over-triage rate was 67.6% (95% CI, 66.34-68.76) and the under-triage rate was 16.2% (95% CI, 15.44-16.90). Dispatch triage sensitivity for all included records was 49.2% (95% CI, 48.10-50.38), specificity 71.9% (95% CI, 71.00-72.92), PPV 32.5% (95% CI, 30.02-34.88), and NPV 83.8% (95% CI, 81.93-85.73). CONCLUSION: This study provides the first evaluation of dispatch triage accuracy in the WCG EMS system, identifying that the system is suffering from both under- and over-triage. Despite variance across dispatch complaints, both under- and over-triage remained higher than widely accepted norms, and all rates were significantly above acceptable target metrics described in similar studies. Results of this study will be used to motivate the development of more rigorous training programs and resources for WCG EMS dispatchers, including improved dispatch protocols for conditions suffering from high over- and under-triage.

Cross-sectional evaluation of emergency care capacity at public hospitals in Zambia.

OBJECTIVES: The last decade has seen rapid expansion of emergency care systems across Africa, although they remain underdeveloped. In Zambia, the Ministry of Health has taken interest in improving the situation and data are needed to appropriately guide system strengthening efforts. The Emergency Care Assessment Tool (ECAT) provides a context-specific means of measuring capacity of healthcare facilities in low- and middle-income countries. We evaluated Zambian public hospitals using the ECAT to inform resource-effective improvements to the nation's healthcare system. METHODS: The ECAT was administered to the lead clinician in the emergency unit at 23 randomly sampled public hospitals across seven of Zambia's 10 provinces in March 2016. Data were collected regarding hospitals' perceived abilities to perform a number of predefined signal functions - life-saving procedures that encompass the need for both skills and resources. Signal functions (36 for intermediate facilities, 51 for advanced) related to six sentinel conditions that represent a large burden of morbidity and mortality from emergencies. We report the proportion of procedures that each level of hospital was capable of, along with barriers to delivery of care. RESULTS: Across all hospitals, most of the level-appropriate emergency care procedures could be performed. Intermediate level (district) hospitals were able to perform 75% (95% CI 73.2 to 76.8) of signal functions for the six conditions. Among advanced level hospitals, provincial hospitals were able to perform 68.6% (67.4% to 69.7%) and central hospitals 96.1% (95% CI 93.5 to 98.7) Main failures in delivery of care were attributed to a lack of healthcare worker training and availability of consumable resources, such as medicines or supplies. CONCLUSION: Zambian public hospitals have reasonable capacity to care for acutely ill and injured patients; however, there is a need for increased training and improved supply chains.

Bridging the [Health Equity] Gap at a Free Clinic for Uninsured Residents of Rhode Island.

Poor management of chronic diseases, such as hypertension and diabetes, particularly among the uninsured, places medical and financial burdens on the healthcare system. Clínica Esperanza/Hope Clinic initiated a chronic disease management program for uninsured residents of Rhode Island (RI) called Bridging the [Health Equity] Gap (BTG), which offers continuity of care, quarterly goal-setting appointments, and healthy lifestyle interventions. Outcomes for 549 participants from the initial evaluation period are presented here. Over the first 12 months of enrollment, mean hemoglobin A1c decreased from 10.2% to 8.3% (p<0.001), and mean blood glucose of individuals with diabetes decreased by 51 mg/dL (p<0.01). BTG participants used the local emergency department (ED) 60% less than Medicaid-insured RI residents and had 61% fewer "potentially preventable" ED visits. The positive impact of BTG on chronic disease outcomes and ED usage by uninsured patients suggests that programs like BTG may reduce overall healthcare costs in the state.

Evaluating emergency care capacity in Africa: an iterative, multicountry refinement of the Emergency Care Assessment Tool.

Healthcare facilities in low-income and middle-income countries lack an objective measurement tool to assess emergency care capacity. The African Federation for Emergency Medicine developed the Emergency Care Assessment Tool (ECAT) to fulfil this function. The ECAT assesses the provision of key medical interventions (signal functions) that emergency units (EUs) should be able to perform to adequately treat six common, life-threatening conditions (sentinel conditions). We describe the piloting and refinement of the ECAT, to improve usability and context-appropriateness. We undertook iterative, multisite refinement of the ECAT. After pilot testing at a South African referral hospital, subsequent studies occurred at district, regional and central facilities across four countries representing the major regions of Africa: Cameroon, Uganda, Egypt and Botswana. At each site, the tool was administered to three participants: one senior physician, one senior nurse and one other clinical provider. Feedback informed refinements of the ECAT, and an updated tool was used in the next-studied country. Iteratively implementing refined versions of the tool in various contexts across Africa resulted in a final ECAT that uses signal functions, categorised by sentinel conditions and evaluated against discrete barriers to emergency care service delivery, to assess EUs. It also allowed for refinement of administration and data analysis processes. The ECAT has a total of 71 items. Advanced facilities are expected to perform all 71 signal functions, while intermediate facilities should be able to perform 53. The ECAT is the first tool to provide a standardised method for assessing facility-based emergency care in the African context. It identifies where in the maturation process a hospital or system is and what gaps exist in delivery of care, so that a comprehensive roadmap for development can be established. Although validity and feasibility testing have now occurred, reliability studies must be conducted prior to amplification across the region.

Essential medicines for emergency care in Africa.

OBJECTIVES: Essential medicines lists (EMLs) are efficient means to ensure access to safe and effective medications. The WHO has led this initiative, generating a biannual EML since 1977. Nearly all countries have implemented national EMLs based on the WHO EML. Although EMLs have given careful consideration to many public health priorities, they have yet to comprehensively address the importance of medicines for treating acute illness and injury. METHODS: We undertook a multistep consensus process to establish an EML for emergency care in Africa. After a review of existing literature and international EMLs, we generated a candidate list for emergency care. This list was reviewed by expert clinicians who ranked the medicines for overall inclusion and strength of recommendation. These medications and recommendations were then evaluated by an expert group. Medications that reached consensus in both the online survey and expert review were included in a draft emergency care EML, which underwent a final inperson consensus process. RESULTS: The final emergency care EML included 213 medicines, 25 of which are not in the 2017 WHO EML, but were deemed essential for clinical practice by regional emergency providers. The final EML has associated recommendations of desirable or essential and is subdivided by facility level. Thirty-nine medicines were recommended for basic facilities, an additional 96 for intermediate facilities (eg, district hospitals) and an additional 78 for advanced facilities (eg, tertiary centres). CONCLUSION: The 25 novel medications not currently on the WHO EML should be considered by planners when making rational formularies for developing emergency care systems. It is our hope that these resource-stratified lists will allow for easier implementation and will be a useful tool for practical expansion of emergency care delivery in Africa.

Developing prehospital clinical practice guidelines for resource limited settings: why re-invent the wheel?

OBJECTIVES: Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, the volume of literature is not matched by research into alternative methods of CPG development using existing CPG documents-a specific issue for guideline development groups in low- and middle-income countries. We report on how we developed a context specific prehospital CPG using an alternative guideline development method. Difficulties experienced and lessons learnt in applying existing global guidelines' recommendations to a national context are highlighted. RESULTS: The project produced the first emergency care CPG for prehospital providers in Africa. It included > 270 CPGs and produced over 1000 recommendations for prehospital emergency care. We encountered various difficulties, including (1) applicability issues: few pre-hospital CPGs applicable to Africa, (2) evidence synthesis: heterogeneous levels of evidence classifications and (3) guideline quality. Learning points included (1) focusing on key CPGs and evidence mapping, (2) searching other resources for CPGs, (3) broad representation on CPG advisory boards and (4) transparency and knowledge translation. Re-inventing the wheel to produce CPGs is not always feasible. We hope this paper will encourage further projects to use existing CPGs in developing guidance to improve patient care in resource-limited settings.

Adapting the emergency first aid responder course for Zambia through curriculum mapping and blueprinting.

OBJECTIVES: Community members are often the first to witness and respond to medical and traumatic emergencies, making them an essential first link to emergency care systems. The Emergency First Aid Responder (EFAR) programme is short course originally developed to help South Africans manage emergencies at the community level, pending arrival of formal care providers. EFAR was implemented in two rural regions of Zambia in 2015, but no changes were originally made to tailor the course to the new setting. We undertook this study to identify potential refinements in the original EFAR curriculum, and to adapt it to the local context in Zambia. DESIGN: The EFAR curriculum was mapped against available chief complaint data. An expert group used information from the map, in tandem with personal knowledge, to rank each course topic for potential impact on patient outcomes and frequency of use in practice. Individual blueprints were compiled to generate a refined EFAR curriculum, the time breakdown of which reflects the relative weight of each topic. SETTING: This study was conducted based on data collected in Kasama, a rural region of Zambia's Northern Province. PARTICIPANTS: An expert group of five physicians practising emergency medicine was selected; all reviewers have expertise in the Zambian context, EFAR programme and/or curriculum development. RESULTS: The range of emergencies that Zambian EFARs encounter indicates that the course must be broad in scope. The refined curriculum covers 54 topics (seven new) and 25 practical skills (five new). Practical and didactic time devoted to general patient care and scene management increased significantly, while time devoted to most other clinical, presentation-based categories (eg, trauma care) decreased. CONCLUSIONS: Discrepancies between original and refined curricula highlight a mismatch between the external curriculum and local context. Even with limited data and resources, curriculum mapping and blueprinting are possible means of resolving these contextual issues.