Smartphone App for Prehospital ECG Transmission in ST-Elevation Myocardial Infarction Activation: Protocol for a Mixed Methods Study.

BACKGROUND: Timely diagnosis and treatment for ST-elevation myocardial infarction (STEMI) requires a coordinated response from multiple providers. Rapid intervention is key to reducing mortality and morbidity. Activation of the cardiac catheterization laboratory may occur through verbal communication and may also involve the secure sharing of electrocardiographic images between frontline health care providers and interventional cardiologists. To improve this response, we developed a quick, easy-to-use, privacy-compliant smartphone app, that is SMART AMI-ACS (Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Acute Coronary Syndromes), for real-time verbal communication and sharing of electrocardiographic images among health care providers in Ontario, Canada. The app further provides information about diagnosis, management, and risk calculators for patients presenting with acute coronary syndrome. OBJECTIVE: This study aims to integrate the app into workflow processes to improve communication for STEMI activation, resulting in decreased treatment times, improved patient outcomes, and reduced unnecessary catheterization laboratory activation and transfer. METHODS: Implementation of the app will be guided by the Reach, Effectiveness, Acceptability, Implementation, and Maintenance (RE-AIM) framework to measure impact. The study will use quantitative registry data already being collected through the SMART AMI project (STEMI registry), the use of the SMART AMI app, and quantitative and qualitative survey data from physicians. Survey questions will be based on the Consolidated Framework for Implementation Research. Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Continuous variables will be described using either mean and SD or median and IQR values at pre- and postintervention periods by the study sites. Categorical variables, such as false activation, will be described as frequencies (percentages). For each outcome, an interrupted time series regression model will be fitted to evaluate the impact of the app. RESULTS: The primary outcomes of this study include the usability, acceptability, and functionality of the app for physicians. This will be measured using electronic surveys to identify barriers and facilitators to app use. Other key outcomes will measure the implementation of the app by reviewing the timing-of-care intervals, false "avoidable" catheterization laboratory activation rates, and uptake and use of the app by physicians. Prospective evaluation will be conducted between April 1, 2022, and March 31, 2023. However, for the timing- and accuracy-of-care outcomes, registry data will be compared from January 1, 2019, to March 31, 2023. Data analysis is expected to be completed in Fall 2024, with the completion of a paper for publication anticipated by the end of 2024. CONCLUSIONS: Smartphone technology is well integrated into clinical practice and widely accessible. The proposed solution being tested is secure and leverages the accessibility of smartphones. Emergency medicine physicians can use this app to quickly, securely, and accurately transmit information ensuring faster and more appropriate decision-making for STEMI activation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05290389; https://clinicaltrials.gov/study/NCT05290389. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55506.

Every problem is embedded in a greater whole.

Peter Drucker pointed out an important distinction between 'doing things right' and 'doing the right thing', which recognised that all problems are embedded in a context and thus can only be understood within their unique contextual setting. Contemporary research practices in clinical medicine often regards contextual factors as potential confounders that will bias effect estimates and thus must be avoided. However rigorous, research devoid of context ultimately deprives users of understanding of the support factors that make research transferable to policy decisions or managing care of individual patients-it stands in the way of 'doing the right thing' in 'real life' settings. Appreciating that all problems are embedded in a greater context means that one should not ignore their interconnected and interdependent systemic nature, that is, every variable is simultaneously dependent and independent. This is the reason for the cascading effects and feedback loops witnessed in disease progression and policy efforts. We discuss the need for researchers to a-priori consider the context of their research question as well as the structural relationships of the variables under investigation, which in turn provides the basis for choosing the most appropriate research design. We have a moral imperative to first 'do the right thing'-ask questions that address the contextual needs of our patients, and then to 'do it right'-choose the best research method to answer this contextually framed need. Only then will our research efforts have meaningful and lasting impacts on patient care.

Which adults aged 65 and older are at low-risk for cervical spine injuries after low-level falls?

OBJECTIVES: The population is aging and falls are a common reason for emergency department visits. Appropriate imaging in this population is important. The objectives of this study were to estimate the prevalence of cervical spine injury and identify factors associated with cervical spine injuries in adults ≥ 65 years after low-level falls. METHODS: This was a pre-specified sub-study of a prospective observational cohort study of intracranial bleeding in emergency patients ≥ 65 years presenting after low-level falls. The primary outcome was cervical spine injury. The risk factors of interest were Glasgow coma scale (GCS) < 15, head injury, neck pain, age, and frailty defined as Clinical Frailty Scale ≥ 5. Multivariable logistic regression was used to measure the strength of association between risk factors and cervical spine injury. A descriptive analysis of absence of significant risk factors was performed to determine patients who may not require imaging. RESULTS: There were 4308 adults ≥ 65 who sustained low-level falls with mean age of 82.0 (standard deviation ± 8.8) years and 1538 (35.7%) were male; 23 [0.5% (95% confidence interval (CI) 0.3-0.8%)] were diagnosed with cervical spine injuries. The adjusted odds ratios and 95% CIs were 1.3 (0.5-3.2) for GCS < 15, 5.3 (1.7-26.7) for head injury, 13.0 (5.7-31.2) for new neck pain, 1.4 (1.0-1.8) for 5-year increase in age, and 1.1 (0.4-2.9) for frailty. Head injury or neck pain identified all 23 cervical spine injuries. Management was a rigid collar in 19/23 (82.6%) patients and none had surgery. CONCLUSIONS: In emergency patients ≥ 65 years presenting after a low-level fall, head injury, neck pain, and older age were associated with the diagnosis of cervical spine injury. There were no cervical spine injuries in those without head injury or neck pain. Patients with no head injury or neck pain may not require cervical spine imaging.

RéSUMé: OBJECTIFS: La population vieillit et les chutes sont une raison courante pour les visites à l'urgence. Il est important d'avoir une imagerie appropriée dans cette population. Les objectifs de cette étude étaient d'estimer la prévalence des lésions de la colonne cervicale et d'identifier les facteurs associés aux lésions de la colonne cervicale chez les adultes de plus de 65 ans après des chutes de faible niveau. MéTHODES: Il s'agissait d'une sous-étude pré-spécifiée d'une étude prospective de cohorte observationnelle de saignements intracrâniens chez des patients d'urgence de plus de 65 ans se présentant après des chutes de faible niveau. Le résultat principal était une lésion de la colonne cervicale. Les facteurs de risque d'intérêt étaient l'échelle de coma de Glasgow (GCS)<15, les blessures à la tête, les douleurs au cou, l'âge et la fragilité définis comme l'échelle de fragilité clinique >5. La régression logistique multivariée a été utilisée pour mesurer la force de l'association entre les facteurs de risque et les lésions de la colonne cervicale. Une analyse descriptive de l'absence de facteurs de risque significatifs a été réalisée pour déterminer les patients qui ne nécessitent pas d'imagerie. RéSULTATS: Il y avait 4308 adultes de plus de 65 ans qui ont subi des chutes de faible intensité avec un âge moyen de 82.0 ans (écart-type 8.8) et 1538 ans (35.7 %) étaient des hommes; 23 (0.5 % (intervalle de confiance à 95 % 0.3­0.8 %) ont reçu un diagnostic de lésions du rachis cervical. Les rapports de cotes ajustés et les IC à 95 % étaient de 1.3 (0.5­3.2) pour les SCM<15, 5.3 (1.7­26.7) pour les blessures à la tête, 13.0 (5.7­31.2) pour les nouvelles douleurs au cou, 1.4 (1.0 ­ 1.8) pour l'augmentation de l'âge de cinq ans et 1.1 (0.4­2.9) pour la fragilité. Des blessures à la tête ou des douleurs au cou ont permis de déceler les 23 blessures à la colonne cervicale. La prise en charge était un collier rigide chez 19 patients sur 23 (82.6 %) et aucun n'a subi de chirurgie. CONCLUSIONS: Chez les patients d'urgence de plus de 65 ans se présentant après une chute de faible intensité, des blessures à la tête, des douleurs au cou et un âge plus avancé ont été associés au diagnostic de lésion de la colonne cervicale. Il n'y avait pas de blessures à la colonne cervicale chez les personnes sans blessure à la tête ou douleur au cou. Les patients sans blessure à la tête ou douleur au cou peuvent ne pas avoir besoin d'imagerie de la colonne cervicale.

Normative challenges in data governance: insights from global health research.

Many important questions in health professions education require datasets that are built from several sources, in some cases using data collected for a different purpose. In building and maintaining these datasets, project leaders will need to make decisions about the data. While such decisions are often construed as technical, there are several normative concerns, such as who should have access, how the data will be used, how products resulting from the data will be shared, and how to ensure privacy of the individuals the data is about is respected, etc. Establishing a framework for data governance can help project leaders in avoiding problems, related to such matters, that could limit what can be learned from the data or that might put the project (or future projects) at risk. In this paper, we highlight several normative challenges to be addressed when determining a data governance framework. Drawing from lessons in global health, we illustrate three kinds of normative challenges for projects that rely on data from multiple sources or involved partnerships across institutions or jurisdictions: (1) legal and regulatory requirements, (2) consent, and (3) equitable sharing and fair distribution.

Evaluation of a single-dose HPV vaccine strategy for promoting vaccine, health, and gender equity.

Although several countries have adopted a single-dose human papillomavirus (HPV) vaccination strategy, many other countries continue to include multiple doses in their vaccination programmes. There are ethical reasons to transition to a single-dose strategy. We discuss how a single-dose HPV vaccination strategy advances equity in three dimensions: vaccine equity, health equity, and gender equity. Adopting a single-dose strategy eases pressure on vaccine supply, lowers programme costs, and is easier to distribute. This change facilitates vaccine procurement and implementation programmes (contributing to vaccine equity) and reaching hard to reach people or populations (contributing to health equity). A lower number of cases of HPV-related diseases that stem from greater vaccine distribution reduces the burden on women, who are at a higher risk of HPV-related disease or who act as caregivers, which prevents them from accessing opportunities that contribute to their empowerment (contributing to gender equity). Thus, pursuing the single-dose HPV vaccination programme strategy is ethically desirable.

Emergency physician gender and head computed tomography orders for older adults who have fallen.

OBJECTIVE: Physicians vary in their computed tomography (CT) scan usage. It remains unclear how physician gender relates to clinical practice or patient outcomes. The aim of this study was to assess the association between physician gender and decision to order head CT scans for older emergency patients who had fallen. METHODS: This was a secondary analysis of a prospective observational cohort study conducted in 11 hospital emergency departments (EDs) in Canada and the United States. The primary study enrolled patients who were 65 years and older who presented to the ED after a fall. The analysis evaluated treating physician gender adjusted for multiple clinical variables. Primary analysis used a hierarchical logistic regression model to evaluate the association between treating physician gender and the patient receiving a head CT scan. Secondary analysis reported the adjusted odds ratio (OR) for diagnosing intracranial bleeding by physician gender. RESULTS: There were 3663 patients and 256 physicians included in the primary analysis. In the adjusted analysis, women physicians were no more likely to order a head CT than men (OR 1.26, 95% confidence interval 0.98-1.61). In the secondary analysis of 2294 patients who received a head CT, physician gender was not associated with finding a clinically important intracranial bleed. CONCLUSIONS: There was no significant association between physician gender and ordering head CT scans for older emergency patients who had fallen. For patients where CT scans were ordered, there was no significant relationship between physician gender and the diagnosis of clinically important intracranial bleeding.

A Longitudinal Survey on Canadian Emergency Physician Burnout.

STUDY OBJECTIVE: Since Canada eased pandemic restrictions, emergency departments have experienced record levels of patient attendance, wait times, bed blocking, and crowding. The aim of this study was to report Canadian emergency physician burnout rates compared with the same physicians in 2020 and to describe how emergency medicine work has affected emergency physician well-being. METHODS: This longitudinal study on Canadian emergency physician wellness enrolled participants in April 2020. In September 2022, participants were invited to a follow-up survey consisting of the Maslach Burnout Inventory and an optional free-text explanation of their experience. The primary outcomes were emotional exhaustion and depersonalization levels, which were compared with the Maslach Burnout Inventory survey conducted at the end of 2020. A thematic analysis identified common stressors, challenges, emotions, and responses among participants. RESULTS: The response rate to the 2022 survey was 381 (62%) of 615 between September 28 and October 28, 2022, representing all provinces or territories in Canada (except Yukon). The median participant age was 42 years. In total, 49% were men, and 93% were staff physicians with a median of 12 years of work experience. 59% of respondents reported high emotional exhaustion, and 64% reported high depersonalization. Burnout levels in 2022 were significantly higher compared with 2020. Prevalent themes included a broken health care system, a lack of societal support, and systemic workplace challenges leading to physician distress and loss of physicians from the emergency workforce. CONCLUSION: We found very high burnout levels in emergency physician respondents that have increased since 2020.

Derivation of the Falls Decision Rule to exclude intracranial bleeding without head CT in older adults who have fallen.

BACKGROUND: Ground-level falls are common among older adults and are the most frequent cause of traumatic intracranial bleeding. The aim of this study was to derive a clinical decision rule that safely excludes clinically important intracranial bleeding in older adults who present to the emergency department after a fall, without the need for a computed tomography (CT) scan of the head. METHODS: This prospective cohort study in 11 emergency departments in Canada and the United States enrolled patients aged 65 years or older who presented after falling from standing on level ground, off a chair or toilet seat, or out of bed. We collected data on 17 potential predictor variables. The primary outcome was the diagnosis of clinically important intracranial bleeding within 42 days of the index emergency department visit. An independent adjudication committee, blinded to baseline data, determined the primary outcome. We derived a clinical decision rule using logistic regression. RESULTS: The cohort included 4308 participants, with a median age of 83 years; 2770 (64%) were female, 1119 (26%) took anticoagulant medication and 1567 (36%) took antiplatelet medication. Of the participants, 139 (3.2%) received a diagnosis of clinically important intracranial bleeding. We developed a decision rule indicating that no head CT is required if there is no history of head injury on falling; no amnesia of the fall; no new abnormality on neurologic examination; and the Clinical Frailty Scale score is less than 5. Rule sensitivity was 98.6% (95% confidence interval [CI] 94.9%-99.6%), specificity was 20.3% (95% CI 19.1%-21.5%) and negative predictive value was 99.8% (95% CI 99.2%-99.9%). INTERPRETATION: We derived a Falls Decision Rule, which requires external validation, followed by clinical impact assessment. Trial registration: ClinicalTrials. gov, no. NCT03745755.

Expediting approval for medical countermeasures to address high burden disease: an ethical justification to move beyond emergency use authorisation.

Addressing global health crises requires a receptive and expedient policy environment to minimise delays in making available potentially life-saving technologies. Over time, the policy environment has adapted to ensure that communities have expedited access to promising technologies, such as vaccines, that can mitigate morbidity and mortality. Emergency authorisations are one such policy mechanism. While these have been employed successfully for several diseases, such as influenza, Ebola and COVID-19, the policy mechanism is tied to contexts where key bodies have designated the disease an 'emergency', whereas no equivalent mechanism exists for those failing to acquire the designation (eg, malaria and tuberculosis). In this paper, we examine ethical issues associated with emergency authorisations. We argue that there is no moral difference between those diseases considered emergencies and many that fail to be designated as such with respect to impact on affected communities. Thus, tying access to an expedient policy mechanism for approval to an emergency designation is ethically unjustified-it should be based on considerations of risks and benefits, the disease burden and the values of the communities that carry those risks and not contingent on if the disease is designated an emergency. We suggest the need to further enhance the policy environment to ensure access to similar expedited approval programmes irrespective of if a disease is an emergency. Levelling the field for access to expedited approval programmes across diseases can help in moving towards achieving global health equity but is not a panacea.

Associations between education policies and the geographic disposition of family physicians: a retrospective observational study of McMaster University education data.

The maldistribution of family physicians challenges equitable primary care access in Canada. The Theory of Social Attachment suggests that preferential selection and distributed training interventions have potential in influencing physician disposition. However, evaluations of these approaches have focused predominantly on rural underservedness, with little research considering physician disposition in other underserved communities. Accordingly, this study investigated the association between the locations from which medical graduates apply to medical school, their undergraduate preclerkship, clerkship, residency experiences, and practice as indexed across an array of markers of underservedness. We built association models concerning the practice location of 347 family physicians who graduated from McMaster University's MD Program between 2010 and 2015. Postal code data of medical graduates' residence during secondary school, pre-clerkship, clerkship, residency and eventual practice locations were coded according to five Statistics Canada indices related to primary care underservedness: relative rurality, employment rate, proportion of visible minorities, proportion of Indigenous peoples, and neighbourhood socioeconomic status. Univariate and multivariable logistic regression models were then developed for each dependent variable (i.e., practice location expressed in terms of each index). Residency training locations were significantly associated with practice locations across all indices. The place of secondary school education also yielded significant relationships to practice location when indexed by employment rate and relative rurality. Education interventions that leverage residency training locations may be particularly influential in promoting family physician practice location. The findings are interpreted with respect to how investment in education policies can promote physician practice in underserved communities.

Humans not heroes: Canadian emergency physician experiences during the early COVID-19 pandemic.

BACKGROUND: The pandemic has upended much clinical care, irrevocably changing our health systems and thrusting emergency physicians into a time of great uncertainty and change. This study is a follow-up to a survey that examined the early pandemic experience among Canadian emergency physicians and aimed to qualitatively describe the experiences of these physicians during the global pandemic. The study was conducted at a time when Canadian COVID-19 case numbers were low. METHODS: The investigators engaged in an interview-based study that used an interpretive description analytic technique, sensitised by the principles of phenomenology. One-to-one interviews were conducted, transcribed and then analysed to establish a codebook, which was subsequently grouped into key themes. Results underwent source triangulation (with survey data from a similar period) and investigator-driven audit trail analysis. RESULTS: A total of 16 interviews (11 female, 5 male) were conducted between May and September 2020. The isolated themes on emergency physicians' experiences during the early pandemic included: (1) disruption and loss of emergency department shift work; (2) stress of COVID-19 uncertainty and information bombardment; (3) increased team bonding; (4) greater personal life stress; (5) concern for patients' isolation, miscommunication and disconnection from care; (6) emotional distress. CONCLUSIONS: Canadian emergency physicians experienced emotional and psychological distress during the early COVID-19 pandemic, at a time when COVID-19 prevalence was low. This study's findings could guide future interventions to protect emergency physicians against pandemic-related distress.

Heterogeneity in multicentre trial participating centers: lessons from the TOPCAT trial on interpreting trial data for clinical practice.

OBJECTIVES: Randomized controlled trials (RCTs) are considered a "gold standard" of evidence, provided they meet rigorous standards in design and execution. Recently, some investigators of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial advocate reanalysis of results, deviating from the statistical analysis plan. We briefly review the rationale by the TOPCAT investigators and implications for interpreting trial data. STUDY DESIGN AND SETTING: Critical examination of existing literature. RESULTS: The TOPCAT trial showed variation in patient characteristics and outcomes among different geographic regions. The investigators suggest that the observed variation indicated unreliable data, warranting deviation from protocol. That lead to claims of therapeutic effectiveness for populations in select regions. We suggest that some variation is expected in multicentre RCTs and argue that discriminating between natural variation and unreliable data can be challenging. Thus, the warrant for deviation from protocol is not clear. CONCLUSION: The TOPCAT investigators highlight important concerns about heterogeneity in RCT samples and how that may impact our interpretation of the results. If we are to maintain rigor in the RCT methodology and preserve its status as a reliable form of evidence for clinical practice, we must carefully consider when it is appropriate to deviate from a protocol when analyzing and interpreting trial data.

The impact of performance feedback reports on physician ordering behavior in the use of computed tomography pulmonary angiography (CTPA).

PURPOSE: The increased utilization, and potential overutilization, of computed tomography pulmonary angiography (CTPA) is a well-recognized issue within emergency departments (EDs). The objective of this study is to determine the impact of performance feedback reports on CTPA ordering behavior among ED physicians. METHODS: We conducted a prospective study of the impact of individualized performance feedback reports on the ordering behavior of physicians working at two high-volume community EDs in Ontario, Canada. We generated individualized reports (or "Dashboards") for each ED physician containing detailed feedback and peer comparison for each physician's CTPA ordering. Our baseline pre-intervention period was January 1 to December 31, 2018, and our intervention period was January 1, 2019, to December 31, 2021. We tracked individual and group ordering behavior through the study period. Our primary outcomes are impact of feedback on (1) overall group ordering rate and (2) overall diagnostic yield. Secondary analysis was done to determine the impact of the intervention on those physicians with the highest CTPA utilization rate. RESULTS: There was no statistically significant difference in the diagnostic yield of the included physicians in either of the years of the intervention period. There was a statically significant increase in the utilization rate for CTPA from 2018 to 2020 and 2021 from 5.9 to 7.9 and 11.4 CTPAs per 1000 ED visits respectively (p < 0.5). CONCLUSION: Our study found no consistent significant impact of individualized feedback and peer comparison on physician ordering of CTPAs. This points to a potentially greater impact of environmental and institutional factors, as opposed to physician-targeted quality improvement measures, on physician ordering behavior.

Clinical recommendations: The role of mechanisms in the GRADE framework.

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework has become one of the most influential frameworks for assessing quality of research and developing clinical recommendations. The GRADE framework has been presented as an evolution in the Evidence-Based Medicine (EBM) movement. Both GRADE and EBM emphasize effect estimates derived from population-level clinical trials and, as a consequence, devalue the role of mechanisms as the basis for clinical decisions. Although mechanisms do not hold the epistemic privilege of rigorous clinical trials in EBM reasoning, this paper will argue that mechanisms appear to be important in the use and application of GRADE, as described in the literature. The seemingly necessary role of mechanisms in the development of clinical recommendations has, so far, received little attention and is not explicitly featured in the literature describing GRADE. The analysis of the GRADE framework presented in this paper reveals an apparent tension between EBM's willingness to downplay mechanisms and what seems their inevitable use in GRADE. In this paper, we take the position that if mechanistic reasoning is inevitable in the use of GRADE, then the instructional literature on the framework would benefit from more explicit discussion of how to consider and integrate mechanisms.