Validating use of diagnostic codes in Canadian administrative data for identification of adverse drug events.

AIMS: While diagnostic codes from administrative health data might be a valuable source to identify adverse drug events (ADEs), their ability to identify unintended harms remains unclear. We validated claims-based diagnosis codes for ADEs based on events identified in a prospective cohort study and assessed whether key attributes predicted their documentation in administrative data. METHODS: This was a retrospective analysis of 3 prospective cohorts in British Columbia, from 2008 to 2015 (n = 13 969). We linked prospectively identified ADEs to administrative insurance data to examine the sensitivity and specificity of different diagnostic code schemes. We used logistic regression to assess which key attributes (e.g., type of event, symptoms and culprit medications) were associated with better documentation of ADEs in administrative data. RESULTS: Among 1178 diagnosed events, the sensitivity of the diagnostic codes in administrative data ranged from 3.4 to 52.6%, depending on the database and codes used. We found that documentation was worse for certain types of ADEs (dose-related: odds ratio [OR]: 0.32, 95% confidence interval [CI]: 0.15, 0.69; nonadherence events (OR: 0.35, 95% CI: 0.20, 0.62), and better for those experiencing arrhythmias (OR: 4.19, 95% CI: 0.96, 18.28). CONCLUSION: ADEs were not well documented in administrative data. Alternative methods should be explored to capture ADEs for health research.

Administrative data ICD-10 diagnostic codes identifies most lab-confirmed SARS-CoV-2 admissions but misses many discharged from the Emergency Department.

We estimated the operating characteristics of ICD-10 code U07.1, introduced by the World Health Organization in 2020, to identify lab-confirmed SARS-CoV-2. CCEDRRN is a national research registry of adults (March 2020-August 2021) with suspected/confirmed SARS-CoV-2 identified in Canadian emergency departments (EDs) using chart review (symptoms, clinical information, and lab test results including SARS-CoV-2 polymerase chain reaction, PCR results). CCEDRRN data were linked to administrative hospitalization discharge and ED ICD-10 diagnostic codes (accessed centrally via the Canadian Institute for Health Information). We identified ICD-10 diagnostic codes in CCEDRRN participants. We defined lab-confirmed SARS-CoV-2 based on at least one positive PCR in the 0-14 days before the ED presentation and/or during hospitalization (in those admitted from ED). We performed separate analyses for CCEDRRN participants discharged from ED and those hospitalized from the ED. Additional analyses were stratified by province, sex, age, and (for hospitalized patients) timing of the first PCR test. The sensitivity of ICD-10 code U07.1 for a positive SARS-CoV-2 test was 93.6% (95% CI 93.0-94.1%) in those hospitalized from ED and 83.0% (95% CI 82.1-83.9%) in those discharged from the ED. Sensitivity was similar across provinces and demographics, but in each stratified analysis, values were higher in those hospitalized versus those discharged from ED. The ICD-10 diagnostic code for U07.1 within administrative data identified most lab-confirmed SARS-CoV-2 within persons hospitalized from ED, although a significant number of cases discharged from ED were missed. This should be considered when using administrative data for research and public health planning.

Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data.

AIMS: Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold standard diagnosis of non-adherence made in hospital. METHODS: This was a retrospective analysis of adverse drug events diagnosed during three prospective cohorts in British Columbia between 2008 and 2015 (n = 976). We linked prospectively identified adverse drug events to medication claims data to examine the sensitivity and specificity of typical non-adherence measures. RESULTS: The sensitivity of the non-adherence measures ranged from 22.4% to 37.5%, with a proportion of days covered threshold of 95% performing the best; the non-persistence measures had sensitivities ranging from 10.4% to 58.3%. While a 7-day gap was most sensitive, it classified 61.2% of the sample as non-adherent, whereas only 19.6% were diagnosed as such in hospital. CONCLUSIONS: The methods used to identify non-adherence in administrative databases are not accurate when compared to a gold standard diagnosis by healthcare providers. Research that has relied on administrative data to identify non-adherent patients both underestimates the magnitude of the problem and may label patients as non-adherent who were in fact adherent.

Characteristics and outcomes of patients with COVID-19 who return to the emergency department: a multicentre observational study by the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN).

OBJECTIVE: Unplanned return emergency department (ED) visits can reflect clinical deterioration or unmet need from the original visit. We determined the characteristics and outcomes of patients with COVID-19 who return to the ED for COVID-19-related revisits. METHODS: This retrospective observational study used data for all adult patients visiting 47 Canadian EDs with COVID-19 between 1 March 2020 and 31 March 2022. Multivariable logistic regression assessed the characteristics associated with having a no return visit (SV=single visit group) versus at least one return visit (MV=return visit group) after being discharged alive at the first ED visit. RESULTS: 39 809 patients with COVID-19 had 44 862 COVID-19-related ED visits: 35 468 patients (89%) had one visit (SV group) and 4341 (11%) returned to the ED (MV group) within 30 days (mean 2.2, SD=0.5 ED visit). 40% of SV patients and 16% of MV patients were admitted at their first visit, and 41% of MV patients not admitted at their first ED visit were admitted on their second visit. In the MV group, the median time to return was 4 days, 49% returned within 72 hours. In multivariable modelling, a repeat visit was associated with a variety of factors including older age (OR=1.25 per 10 years, 95% CI (1.22 to 1.28)), pregnancy (1.86 (1.46 to 2.36)) and presence of comorbidities (eg, 1.72 (1.40 to 2.10) for cancer, 2.01 (1.52 to 2.66) for obesity, 2.18 (1.42 to 3.36) for organ transplant), current/prior substance use, higher temperature or WHO severe disease (1.41 (1.29 to 1.54)). Return was less likely for females (0.82 (0.77 to 0.88)) and those boosted or fully vaccinated (0.48 (0.34 to 0.70)). CONCLUSIONS: Return ED visits by patients with COVID-19 within 30 days were common during the first two pandemic years and were associated with multiple factors, many of which reflect known risk for worse outcomes. Future studies should assess reasons for revisit and opportunities to improve ED care and reduce resource use. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04702945.

Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study.

BACKGROUND: Robust adverse drug event (ADE) reporting systems are crucial to monitor and identify drug safety signals, but the quantity and type of ADEs captured may vary by system characteristics. OBJECTIVE: We compared ADEs reported in 2 different reporting systems in the same jurisdictions, the Patient Safety and Learning System-Adverse Drug Reaction (PSLS-ADR) and ActionADE, to understand report variation. METHODS: This retrospective observational study analyzed reports entered into PSLS-ADR and ActionADE systems between December 1, 2019, and December 31, 2022. We conducted a comprehensive analysis including all events from both reporting systems to examine coverage and usage and understand the types of events captured in both systems. We calculated descriptive statistics for reporting facility type, patient demographics, serious events, and most reported drugs. We conducted a subanalysis focused on adverse drug reactions to enable direct comparisons between systems in terms of the volume and events reported. We stratified results by reporting system. RESULTS: We performed the comprehensive analysis on 3248 ADE reports, of which 12.4% (375/3035) were reported in PSLS-ADR and 87.6% (2660/3035) were reported in ActionADE. Distribution of all events and serious events varied slightly between the 2 systems. Iohexol, gadobutrol, and empagliflozin were the most common culprit drugs (173/375, 46.2%) in PSLS-ADR, while hydrochlorothiazide, apixaban, and ramipril (308/2660, 11.6%) were common in ActionADE. We included 2728 reports in the subanalysis of adverse drug reactions, of which 12.9% (353/2728) were reported in PSLS-ADR and 86.4% (2357/2728) were reported in ActionADE. ActionADE captured 4- to 6-fold more comparable events than PSLS-ADR over this study's period. CONCLUSIONS: User-friendly and robust reporting systems are vital for pharmacovigilance and patient safety. This study highlights substantial differences in ADE data that were generated by different reporting systems. Understanding system factors that lead to varying reporting patterns can enhance ADE monitoring and should be taken into account when evaluating drug safety signals.

Heatstroke presentations to urban hospitals during BC's extreme heat event: lessons for the future.

BACKGROUND: Climate change is leading to more extreme heat events in temperate climates that typically have low levels of preparedness. Our objective was to describe the characteristics, treatments, and outcomes of adults presenting to hospitals with heatstroke during BC's 2021 heat dome. METHODS: We conducted a review of consecutive adults presenting to 7 hospitals in BC's Lower Mainland. We screened the triage records of all patients presenting between June 25th and 30th, 2021 for complaints related to heat, and reviewed the full records of those who met heatstroke criteria. Our primary outcome was in-hospital mortality. We used Mann-Whitney U tests and logistic regression to investigate associations between patient and treatment factors and mortality. RESULTS: Among 10,247 consecutive presentations to urban hospitals during the extreme heat event, 1.3% (139; 95% confidence intervals [CI] 1.1-1.6%) met criteria for heatstroke. Of heatstroke patients, 129 (90.6%) were triaged into the two highest acuity levels. Patients with heatstroke had a median age of 84.4 years, with 122 (87.8%) living alone, and 101 (84.2%) unable to activate 911 themselves. A minority (< 5, < 3.6%) of patients presented within 48 h of the onset of extreme heat. Most patients (107, 77.0%) required admission, and 11.5% (16) died in hospital. Hypotension on presentation was associated with mortality (odds ratio [OR] 5.3). INTERPRETATION: Heatstroke patients were unable to activate 911 themselves, and most presented with a 48-h delay. This delay may represent a critical window of opportunity for pre-hospital and hospital systems to prepare for the influx of high-acuity resource-intensive patients.

RéSUMé: CONTEXTE: Les changements climatiques entraînent une augmentation des épisodes de chaleur extrême dans les climats tempérés qui ont généralement de faibles niveaux de préparation. Notre objectif était de décrire les caractéristiques, les traitements et les résultats des adultes présentant un coup de chaleur à l'hôpital pendant le dôme de chaleur de 2021 en Colombie-Britannique. MéTHODES: Nous avons effectué un examen des adultes consécutifs qui se sont présentés dans sept hôpitaux du Lower Mainland de la Colombie-Britannique. Nous avons examiné les dossiers de triage de tous les patients qui se sont présentés entre le 25 et le 30 juin 2021 pour les plaintes liées à la chaleur et examiné les dossiers complets de ceux qui répondaient aux critères de coup de chaleur. Notre principal résultat était la mortalité à l'hôpital. Nous avons utilisé les tests de Mann-Whitney U et la régression logistique pour étudier les associations entre le patient et les facteurs de traitement et la mortalité. RéSULTATS: Parmi les 10247 présentations consécutives aux hôpitaux urbains pendant l'événement de chaleur extrême, 1,3 % (139; intervalles de confiance [IC] à 95 %) répondaient aux critères de coup de chaleur. Parmi les patients ayant subi un coup de chaleur, 129 (90,6 %) ont été classés dans les deux niveaux d'acuité les plus élevés. Les patients atteints d'un coup de chaleur avaient un âge médian de 84,4 ans, 122 (87,8 %) vivant seuls et 101 (84,2 %) incapables d'activer le 911 eux-mêmes. Une minorité (< 5, < 3,6 %) de patients se sont présentés dans les 48 heures suivant l'apparition de la chaleur extrême. La plupart des patients (107, 77,0 %) ont dû être admis et 11,5 % (16) sont décédés à l'hôpital. L'hypotension au moment de la présentation était associée à la mortalité (rapport de cotes [RC] 5.3). INTERPRéTATION: Les patients atteints d'un coup de chaleur n'ont pas pu activer le 911 eux-mêmes, et la plupart se sont présentés avec un délai de 48 heures. Ce délai peut représenter une fenêtre critique d'opportunité pour les systèmes préhospitaliers et hospitaliers de se préparer à l'afflux de patients à forte intensité de ressources.

Characterizing intubation practices in response to the COVID-19 pandemic: a survey of the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) sites.

OBJECTIVE: The risk of occupational exposure during endotracheal intubation has required the global Emergency Medicine (EM), Anesthesia, and Critical Care communities to institute new COVID- protected intubation guidelines, checklists, and protocols. This survey aimed to deepen the understanding of the changes in intubation practices across Canada by evaluating the pre-COVID-19, early-COVID-19, and present-day periods, elucidating facilitators and barriers to implementation, and understanding provider impressions of the effectiveness and safety of the changes made. METHODS: We conducted an electronic, self-administered, cross-sectional survey of EM physician site leads within the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) to characterize and compare airway management practices in the pre-COVID-19, early-COVID-19, and present-day periods. Ethics approval for this study was obtained from the University of Manitoba Health Research Ethics Board. The electronic platform SurveyMonkey ( www.surveymonkey.com ) was used to collect and store survey tool responses. Categorical item responses, including the primary outcome, are reported as numbers and proportions. Variations in intubation practices over time were evaluated through mixed-effects logistic regression models. RESULTS: Invitations were sent to 33 emergency department (ED) physician site leads in the CCEDRRN. We collected 27 survey responses, 4 were excluded, and 23 analysed. Responses were collected in English (87%) and French (13%), from across Canada and included mainly physicians practicing in mainly Academic and tertiary sites (83%). All respondents reported that the intubation protocols used in their EDs changed in response to the COVID-19 pandemic (100%, n = 23, 95% CI 0.86-1.00). CONCLUSIONS: This study provides a novel summary of changes to airway management practices in response to the evolving COVID-19 pandemic in Canada. Information from this study could help inform a consensus on safe and effective emergent intubation of persons with communicable respiratory infections in the future.

Sharing Adverse Drug Event Reports Between Hospitals and Community Pharmacists to Inform Re-dispensing: An Analysis of Reports and Process Outcomes.

INTRODUCTION: Adverse drug events (ADEs) are a leading cause of unplanned hospital visits. We designed ActionADE, an online ADE reporting platform, and integrated it with PharmaNet, British Columbia's (BC's) provincial medication dispensing system, to overcome identified barriers in ADE reporting and communicate ADEs to community pharmacies. Our objectives were to characterise ADEs reported in ActionADE, explore associations between patients' age, sex and ADE characteristics, and estimate the re-dispensation rate of culprit medications in community pharmacies. METHODS: We conducted a prospective observational study of ADE reporting in four BC hospitals between April 1, 2020 and October 31, 2022. We described the characteristics of ADEs reported into ActionADE, used logistic regression modelling to examine associations between age and sex and ADE characteristics, and calculated rates of avoided culprit drug re-dispensations using community pharmacists' responses to ActionADE alerts. RESULTS: In total, 3591 ADE reports were initiated by hospital clinicians, 3174 of which were included in this analysis. Serious or life-threatening ADEs resulting in permanent disability, hospitalisation, extended hospitalisation, and/or death accounted for 28.5% (906/3174; 95% CI 27.0-30.1%) of reports. Males were more likely to have non-adherence reported compared to females and experienced life threatening ADEs at a younger age than females. Of 592 patients who had ≥ 1 adverse drug reaction or allergy report (a subset of ADEs) transmitted to community pharmacies, 200 subsequently attempted to re-fill the culprit or a same class drug. Community pharmacists responded to preventative alerts by avoiding re-dispensation in 33.0% (66/200; 95% CI 26.5-39.5%). INTERPRETATION: ActionADE is the first interoperable system that communicates ADEs via a central medication database to community pharmacies. Every 10th ADE reported in ActionADE and shared to PharmaNet resulted in community pharmacists' avoiding one culprit or same class drug re-exposure. Further research is needed to understand ActionADE's impact on patient and health system outcomes.

Comparing methods to classify admitted patients with SARS-CoV-2 as admitted for COVID-19 versus with incidental SARS-CoV-2: A cohort study.

INTRODUCTION: Not all patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection develop symptomatic coronavirus disease 2019 (COVID-19), making it challenging to assess the burden of COVID-19-related hospitalizations and mortality. We aimed to determine the proportion, resource utilization, and outcomes of SARS-CoV-2 positive patients admitted for COVID-19, and assess the impact of using the Center for Disease Control's (CDC) discharge diagnosis-based algorithm and the Massachusetts state department's drug administration-based classification system on identifying admissions for COVID-19. METHODS: In this retrospective cohort study, we enrolled consecutive SARS-CoV-2 positive patients admitted to one of five hospitals in British Columbia between December 19, 2021 and May 31,2022. We completed medical record reviews, and classified hospitalizations as being primarily for COVID-19 or with incidental SARS-CoV-2 infection. We applied the CDC algorithm and the Massachusetts classification to estimate the difference in hospital days, intensive care unit (ICU) days and in-hospital mortality and calculated sensitivity and specificity. RESULTS: Of 42,505 Emergency Department patients, 1,651 were admitted and tested positive for SARS-CoV-2, with 858 (52.0%, 95% CI 49.6-54.4) admitted for COVID-19. Patients hospitalized for COVID-19 required ICU admission (14.0% versus 8.2%, p<0.001) and died (12.6% versus 6.4%, p<0.001) more frequently compared with patients with incidental SARS-CoV-2. Compared to case classification by clinicians, the CDC algorithm had a sensitivity of 82.9% (711/858, 95% CI 80.3%, 85.4%) and specificity of 98.1% (778/793, 95% CI 97.2%, 99.1%) for COVID-19-related admissions and underestimated COVID-19 attributable hospital days. The Massachusetts classification had a sensitivity of 60.5% (519/858, 95% CI 57.2%, 63.8%) and specificity of 78.6% (623/793, 95% CI 75.7%, 81.4%) for COVID-19-related admissions, underestimating total number of hospital and ICU bed days while overestimating COVID-19-related intubations, ICU admissions, and deaths. CONCLUSION: Half of SARS-CoV-2 hospitalizations were for COVID-19 during the Omicron wave. The CDC algorithm was more specific and sensitive than the Massachusetts classification, but underestimated the burden of COVID-19 admissions. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04702945.

An external facilitation intervention to increase uptake of an adverse drug event reporting intervention.

Background: Adverse drug events (ADEs) are a leading cause of emergency department visits and hospital admissions in Canada. ActionADE prevents repeat ADEs by enabling clinicians to document and communicate standardized ADE information across care settings. We used an external facilitation intervention to promote the uptake of ActionADE in four hospitals in British Columbia, Canada. This study examined whether, how and in what context external facilitation influenced the uptake of ActionADE. Methods: In this convergent-parallel mixed-methods study, an external facilitator used a four-step iterative process to support site champions using context-specific implementation strategies to increase the ADE reporting rate at their sites. We extracted archival data to assess implementation determinants before and after the implementation of the external facilitation and implementation strategies. We also retrieved data on the mean monthly counts of reported ADEs for each user from the ActionADE server. Zero-inflated Poisson models were used to examine changes in mean monthly counts of reported ADEs per user between pre-intervention (June 2021 to October 2021) and intervention (November 2021 to March 2022) periods. Results: The external facilitator and site champions co-created three functions: (1) educate pharmacists about what and how to report in ActionADE, (2) educate pharmacists about the impact of ActionADE on patient outcomes, and (3) provide social support for pharmacists to integrate ADE reporting into clinical workflows. Site champions used eight forms to address the three functions. Peer support and reporting competition were the two common strategies used by all sites. Sites' responses to external facilitation varied. The rate of mean monthly counts of reported ADEs per user significantly increased during the intervention period compared to the pre-intervention period at LGH (RR: 3.74, 95% CI 2.78 to 5.01) and RH (RR: 1.43, 95% CI 1.23 to 1.94), but did not change at SPH (RR: 0.68, 95% CI: 0.43 to 1.09) and VGH (RR: 1.17, 95% CI 0.92 to 1.49). Leave of absence of the clinical pharmacist champion and failure to address all identified functions were implementation determinants that influenced the effectiveness of external facilitation. Conclusion: External facilitation effectively supported researchers and stakeholders to co-create context-specific implementation strategies. It increased ADE reporting at sites where clinical pharmacist champions were available, and where all functions were addressed.

Accuracy of Self-Reported COVID-19 Vaccination Status Compared With a Public Health Vaccination Registry in Québec: Observational Diagnostic Study.

BACKGROUND: The accuracy of self-reported vaccination status is important to guide real-world vaccine effectiveness studies and policy making in jurisdictions where access to electronic vaccine registries is restricted. OBJECTIVE: This study aimed to determine the accuracy of self-reported vaccination status and reliability of the self-reported number of doses, brand, and time of vaccine administration. METHODS: This diagnostic accuracy study was completed by the Canadian COVID-19 Emergency Department Rapid Response Network. We enrolled consecutive patients presenting to 4 emergency departments (EDs) in Québec between March 24, 2020, and December 25, 2021. We included adult patients who were able to consent, could speak English or French, and had a proven COVID-19 infection. We compared the self-reported vaccination status of the patients with their vaccination status in the electronic Québec Vaccination Registry. Our primary outcome was the accuracy of the self-reported vaccination status (index test) ascertained during telephone follow-up compared with the Québec Vaccination Registry (reference standard). The accuracy was calculated by dividing all correctly self-reported vaccinated and unvaccinated participants by the sum of all correctly and incorrectly self-reported vaccinated and unvaccinated participants. We also reported interrater agreement with the reference standard as measured by unweighted Cohen κ for self-reported vaccination status at telephone follow-up and at the time of their index ED visit, number of vaccine doses, and brand. RESULTS: During the study period, we included 1361 participants. At the time of the follow-up interview, 932 participants reported at least 1 dose of a COVID-19 vaccine. The accuracy of the self-reported vaccination status was 96% (95% CI 95%-97%). Cohen κ for self-reported vaccination status at phone follow-up was 0.91 (95% CI 0.89-0.93) and 0.85 (95% CI 0.77-0.92) at the time of their index ED visit. Cohen κ was 0.89 (95% CI 0.87-0.91) for the number of doses, 0.80 (95% CI 0.75-0.84) for the brand of the first dose, 0.76 (95% CI 0.70-0.83) for the brand of the second dose, and 0.59 (95% CI 0.34-0.83) for the brand of the third dose. CONCLUSIONS: We reported a high accuracy of self-reported vaccination status for adult patients without cognitive disorders who can express themselves in English or French. Researchers can use self-reported COVID-19 vaccination data on the number of doses received, vaccine brand name, and timing of vaccination to guide future research with patients who are capable of self-reporting their vaccination data. However, access to official electronic vaccine registries is still needed to determine the vaccination status in certain susceptible populations where self-reported vaccination data remain missing or impossible to obtain. TRIAL REGISTRATION: Clinicaltrials.gov NCT04702945; https://clinicaltrials.gov/ct2/show/NCT04702945.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients' perspectives.

BACKGROUND: Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients' perspectives about research recruitment and consent for research studies about COVID-19. METHODS: We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element. RESULTS: Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants' willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19. CONCLUSIONS: Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Due to the COVID-19 pandemic, many research groups started conducting research activities virtually. In this study, we invited individuals who had COVID-19 to share their views about how researchers recruit patients and get their consent to participate in studies about COVID-19. Through interviews and focus groups, we found that British Columbians who had COVID-19 are motivated to participate in COVID-related studies, as long as researchers maintain usual precautions around data privacy and accommodate preferences for participation. Future studies may use these patient perspectives to make informed decisions that will increase and support patient recruitment, consent and retention in research studies.

Intubation practices and outcomes for patients with suspected or confirmed COVID-19: a national observational study by the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN).

OBJECTIVE: Intubation practices changed during the COVID-19 pandemic to protect healthcare workers from transmission of disease. Our objectives were to describe intubation characteristics and outcomes for patients tested for SARS CoV-2 infection. We compared outcomes between patients testing SARS COV-2 positive with those testing negative. METHODS: We conducted a health records review using the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) registry. We included consecutive eligible patients who presented to one of 47 EDs across Canada between March 1, 2020 and June 20, 2021, were tested for SARS-CoV-2 and intubated in the ED. The primary outcome was the proportion of patients experiencing a post-intubation adverse event during the ED stay. Secondary outcomes included first-pass success, intubation practices, and hospital mortality. We used descriptive statistics to summarize variables with subgroup differences examined using t tests, z tests, or chi-squared tests where appropriate with 95% CIs. RESULTS: Of 1720 patients with suspected COVID-19 who were intubated in the ED during the study period, 337 (19.6%) tested SARS-CoV-2 positive and 1383 (80.4%) SARS-CoV-2 negative. SARS-CoV-2 positive patients presented to hospital with lower oxygen levels than SARS-CoV-2 negative patients (mean pulse oximeter SaO2 86 vs 94%, p < 0.001). In total, 8.5% of patients experienced an adverse event post-intubation. More patients in the SARS-CoV-2 positive subgroup experienced post-intubation hypoxemia (4.5 vs 2.2%, p = 0.019). In-hospital mortality was greater for patients who experienced intubation-related adverse events (43.2 vs 33.2%, p = 0.018). There was no significant difference in adverse event-associated mortality by SARS-CoV-2 status. First-pass success was achieved in 92.4% of all intubations, with no difference by SARS-CoV-2 status. CONCLUSIONS: During the COVID-19 pandemic, we observed a low risk of adverse events associated with intubation, even though hypoxemia was common in patients with confirmed SARS-CoV-2. We observed high rates of first-pass success and low rates of inability to intubate. The limited number of adverse events precluded multivariate adjustments. Study findings should reassure emergency medicine practitioners that system modifications made to intubation processes in response to the COVID-19 pandemic do not appear to be associated with worse outcomes compared to pre-COVID-19 practices.

RéSUMé: OBJECTIF: Les pratiques d'intubation ont changé au cours de la pandémie de COVID-19 afin de protéger le personnel de santé contre la transmission de la maladie. Nos objectifs étaient de décrire les caractéristiques de l'intubation et les résultats pour les patients testés pour l'infection par le CoV-2 du SRAS. Nous avons comparé les résultats entre les patients testés positifs au SARS COV-2 et ceux testés négatifs. MéTHODES: Nous avons effectué un examen des dossiers de santé à l'aide du registre du Réseau canadien d'intervention rapide dans les services d'urgence pour la COVID-19 (RCIRSUC). Nous avons inclus les patients éligibles consécutifs qui se sont présentés à l'un des 47 services d'urgence du Canada entre le 1er mars 2020 et le 20 juin 2021, qui ont été testés pour le SRAS-CoV-2 et qui ont été intubés dans le service d'urgence. Le résultat principal était la proportion de patients ayant subi un événement indésirable après l'intubation pendant leur séjour aux urgences. Les critères de jugement secondaires comprenaient le succès du premier passage, les pratiques d'intubation et la mortalité hospitalière. Nous avons utilisé des statistiques descriptives pour résumer les variables avec des différences de sous-groupes examinées à l'aide de tests t, de tests z ou de tests du chi carré, le cas échéant, avec des IC à 95%. RéSULTATS: Sur les 1720 patients suspects de COVID-19 qui ont été intubés aux urgences pendant la période de l'étude, 337 (19,6%) ont été testés positifs au SARS-CoV-2 et 1383 (80,4%) négatifs au SARS-CoV-2. Les patients positifs au SRAS-CoV-2 se sont présentés à l'hôpital avec des niveaux d'oxygène inférieurs à ceux des patients négatifs pour le SRAS-CoV-2 (oxymètre de pouls moyen SaO2 86% contre 94%, p < 0,001). Au total, 8,5% des patients ont présenté un événement indésirable après l'intubation. Un plus grand nombre de patients du sous-groupe positif au SRAS-CoV-2 ont présenté une hypoxémie post-intubation (4,5% vs 2,2%, p = 0,019). La mortalité hospitalière était plus élevée chez les patients ayant subi des événements indésirables liés à l'intubation (43,2% vs 33,2%, p = 0,018). Il n'y avait pas de différence significative dans la mortalité associée aux événements indésirables selon le statut du SRAS-CoV-2. Le succès du premier passage a été obtenu dans 92,4% de toutes les intubations, sans différence selon le statut SARS-CoV-2 CONCLUSIONS: Pendant la pandémie de COVID-19, nous avons observé un faible risque d'événements indésirables associés à l'intubation, même si l'hypoxémie était fréquente chez les patients atteints de SRAS-CoV-2 confirmé. Nous avons observé des taux élevés de réussite du premier passage et des taux faibles d'incapacité à intuber. Le nombre limité d'événements indésirables a empêché les ajustements multivariés. Les résultats de l'étude devraient rassurer les praticiens de la médecine d'urgence que les modifications apportées aux processus d'intubation en réponse à la pandémie de COVID-19 ne semblent pas être associées à des résultats plus défavorables que les pratiques antérieures à la pandémie de COVID-19.

The burden of incidental SARS-CoV-2 infections in hospitalized patients across pandemic waves in Canada.

Many health authorities differentiate hospitalizations in patients infected with SARS-CoV-2 as being "for COVID-19" (due to direct manifestations of SARS-CoV-2 infection) versus being an "incidental" finding in someone admitted for an unrelated condition. We conducted a retrospective cohort study of all SARS-CoV-2 infected patients hospitalized via 47 Canadian emergency departments, March 2020-July 2022 to determine whether hospitalizations with "incidental" SARS-CoV-2 infection are less of a burden to patients and the healthcare system. Using a priori standardized definitions applied to hospital discharge diagnoses in 14,290 patients, we characterized COVID-19 as (i) the "Direct" cause for the hospitalization (70%), (ii) a potential "Contributing" factor for the hospitalization (4%), or (iii) an "Incidental" finding that did not influence the need for admission (26%). The proportion of incidental SARS-CoV-2 infections rose from 10% in Wave 1 to 41% during the Omicron wave. Patients with COVID-19 as the direct cause of hospitalization exhibited significantly longer LOS (mean 13.8 versus 12.1 days), were more likely to require critical care (22% versus 11%), receive COVID-19-specific therapies (55% versus 19%), and die (17% versus 9%) compared to patients with Incidental SARS-CoV-2 infections. However, patients hospitalized with incidental SARS-CoV-2 infection still exhibited substantial morbidity/mortality and hospital resource use.

Prognostic association between d-dimer thresholds and 30-day pulmonary embolism diagnosis among emergency department patients with suspected SARS-CoV-2 infection: a Canadian COVID-19 Emergency Department Rapid Response Network study.

OBJECTIVE: The primary objective was to quantify the prognostic association between various D-dimer thresholds and 30-day PE diagnosis among emergency department (ED) patients with suspected SARS-CoV-2 infection. METHODS: This was a retrospective study of patients enrolled in the Canadian COVID-19 ED Rapid Response Network (CCEDRRN) registry from March 1, 2020 to July 2, 2021. We included consecutive adults (≥ 18 years) presenting to 49 EDs with chest pain, shortness of breath, hypoxia, syncope, presyncope, or hemoptysis who were tested for both SARS-CoV-2 and D-dimer at index ED visit. The primary outcome measure was the sensitivity, specificity, and negative predictive value of D-dimer test thresholds for the outcome of 30-day PE diagnosis. RESULTS: Among 10,837 patients included in our study, 404 (3.7%) were diagnosed with PE at 30-days. A standard D-Dimer threshold of 500 ng/mL had a sensitivity of 97.8% (95% confidence interval [CI] 95.8-99.0%), specificity of 40.9% (95% CI 39.9-41.8%), and negative predictive value of 99.8% (95% CI 99.6-99.9%). An age-adjusted D-dimer threshold had a sensitivity of 96.0% (95% CI 93.6-97.7%), specificity of 48.5% (95% CI 47.5-49.4%), and negative predictive value of 99.7% (95% CI 99.5-99.8%). D-dimer testing had slightly lower prognostic performance among SARS-CoV-2 positive compared to SARS-CoV-2 negative patients in predicting 30-day PE diagnosis. CONCLUSIONS: Among ED patients with suspected SARS-CoV-2, the standard 500 ng/mL and age-adjusted D-dimer thresholds were comparable for the prediction of PE at 30-days. The prognostic performance of D-dimer was lower among SARS-CoV-2 positive patients. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04702945.

RéSUMé: OBJECTIF: L'objectif principal était de quantifier l'association pronostique entre différents seuils de D-dimères et le diagnostic d'EP à 30 jours chez les patients des services d'urgence suspectés d'être infectés par le SRAS-CoV-2. MéTHODES: Il s'agissait d'une étude rétrospective des patients inscrits au registre du réseau canadien de réponse rapide aux urgences COVID-19 (CCEDRRN) du 1er mars 2020 au 2 juillet 2021. Nous avons inclus des adultes consécutifs (>18 ans) se présentant dans 49 services d'urgence pour une douleur thoracique, un essoufflement, une hypoxie, une syncope, une présyncope ou une hémoptysie et qui ont été testés à la fois pour le SRAS-CoV-2 et les D-dimères lors de la visite de référence aux urgences. Le principal critère d'évaluation était la sensibilité, la spécificité et la valeur prédictive négative des seuils du test des D-dimères pour le diagnostic de l'EP à 30 jours. RéSULTATS: Parmi les 10 837 patients inclus dans notre étude, 404 (3,7 %) ont reçu un diagnostic d'EP à 30 jours. Un seuil standard de D-Dimer de 500 ng/mL avait une sensibilité de 97,8 % (intervalle de confiance [IC] à 95 % 95,8-99,0 %), une spécificité de 40,9 % (IC à 95 % 39,9-41,8 %) et une valeur prédictive négative de 99,8 % (IC à 95 % 99,6-99,9 %). Un seuil de D-dimères ajusté à l'âge avait une sensibilité de 96,0% (IC à 95 % 93,6-97,7 %), une spécificité de 48,5% (IC à 95 % 47,5-49,4 %) et une valeur prédictive négative de 99,7 % (IC à 95 % 99,5-99,8 %). Le test des D-dimères avait une performance pronostique légèrement inférieure chez les patients positifs pour le SRAS-CoV-2 par rapport aux patients négatifs pour le SRAS-CoV-2 en ce qui concerne la prédiction du diagnostic d'EP à 30 jours. CONCLUSIONS: Chez les patients des urgences suspectés d'être atteints du SRAS-CoV-2, les seuils standard de 500 ng/ml et les seuils de D-dimères ajustés à l'âge étaient comparables pour la prédiction de l'EP à 30 jours. La performance pronostique des D-dimères était plus faible chez les patients positifs pour le SRAS-CoV-2. ENREGISTREMENT DE L'ESSAI: Clinicaltrials.gov, NCT04702945.

Derivation and validation of a clinical decision rule to risk-stratify COVID-19 patients discharged from the emergency department: The CCEDRRN COVID discharge score.

Objective: To risk-stratify COVID-19 patients being considered for discharge from the emergency department (ED). Methods: We conducted an observational study to derive and validate a clinical decision rule to identify COVID-19 patients at risk for hospital admission or death within 72 hours of ED discharge. We used data from 49 sites in the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) between March 1, 2020, and September 8, 2021. We randomly assigned hospitals to derivation or validation and prespecified clinical variables as candidate predictors. We used logistic regression to develop the score in a derivation cohort and examined its performance in predicting short-term adverse outcomes in a validation cohort. Results: Of 15,305 eligible patient visits, 535 (3.6%) experienced the outcome. The score included age, sex, pregnancy status, temperature, arrival mode, respiratory rate, and respiratory distress. The area under the curve was 0.70 (95% confidence interval [CI] 0.68-0.73) in derivation and 0.71 (95% CI 0.68-0.73) in combined derivation and validation cohorts. Among those with a score of 3 or less, the risk for the primary outcome was 1.9% or less, and the sensitivity of using 3 as a rule-out score was 89.3% (95% CI 82.7-94.0). Among those with a score of ≥9, the risk for the primary outcome was as high as 12.2% and the specificity of using 9 as a rule-in score was 95.6% (95% CI 94.9-96.2). Conclusion: The CCEDRRN COVID discharge score can identify patients at risk of short-term adverse outcomes after ED discharge with variables that are readily available on patient arrival.

Beliefs and perceptions of patient safety event reporting in a Canadian Emergency Department: a qualitative study.

OBJECTIVES: Patient safety events (PSEs) are unwanted or unexpected events that occur during medical care. High cognitive loads and frequent interruptions make emergency departments (EDs) uniquely error prone environments. Yet, frontline clinicians rarely report PSEs using incident reporting systems. The incidence, severity, and preventability of PSEs thus remain poorly understood, and contributing factors are understudied. We sought to understand ED staff beliefs and perceptions about their PSE reporting system and what features they believe are important in such a system. METHODS: We conducted a qualitative study among healthcare providers working in the ED and departmental leadership. We recruited participants via email and held a series of interviews, focus groups, and participatory workshops. We iteratively analyzed the data using the constant comparative method and used thematic analysis to establish themes. RESULTS: 50 participants attended at least one focus group, interview, or workshop. Participants perceived that PSE reporting through formal channels in the ED was challenging. Clinicians had an inherent desire to report PSEs and do so through numerous informal channels, yet underreported in formal reporting systems. The current PSE reporting system did not meet frontline staff needs and was viewed as ineffective in improving care quality and safety. We identified three key features for an improved PSE reporting system: (1) clear definitions; (2) transparency; and (3) simplicity. CONCLUSIONS: In this study, we have identified ideal features for PSE reporting processes to meet the needs of both frontline staff and departmental leadership based on perceptions of current PSE reporting practices. Improved PSE reporting processes have the potential to increase PSE reporting in the ED overall, increasing the availability of information about PSEs to support quality improvement and improve patient safety.

RéSUMé: OBJECTIFS: Les événements liés à la sécurité des patients (ESP) sont des événements non désirés ou inattendus qui se produisent pendant les soins médicaux. La charge cognitive élevée et les interruptions fréquentes font des services d'urgence des environnements particulièrement propices aux erreurs. Pourtant, les cliniciens de première ligne signalent rarement les ESP à l'aide des systèmes de déclaration des incidents. L'incidence, la gravité et le caractère évitable des ESP restent donc mal compris, et les facteurs contributifs sont peu étudiés. Nous avons cherché à comprendre les croyances et les perceptions du personnel des services d'urgence à l'égard de leur système de déclaration des ESP et les caractéristiques qu'ils jugent importantes dans un tel système. MéTHODES: Nous avons mené une étude qualitative auprès des prestataires de soins de santé travaillant aux urgences et de la direction du service. Nous avons recruté des participants par courrier électronique et organisé une série d'entretiens, de groupes de discussion et d'ateliers participatifs. Nous avons analysé les données de manière itérative en utilisant la méthode comparative constante et avons utilisé l'analyse thématique pour établir des thèmes. RéSULTATS: 50 participants ont assisté à au moins un groupe de discussion, une entrevue ou un atelier. Les participants estiment qu'il est difficile de rendre compte de l'ESP par les voies officielles au sein de l'urgence. Les cliniciens avaient un désir inhérent de signaler les ESP et le faisaient par de nombreuses voies informelles, mais ils étaient sous-déclarés dans les systèmes de déclaration officiels. Le système actuel de déclaration des ESP ne répondait pas aux besoins du personnel de première ligne et était considéré comme inefficace pour améliorer la qualité et la sécurité des soins. Nous avons identifié trois caractéristiques clés pour un système amélioré de rapports sur les ESP : (1) des définitions claires ; (2) la transparence ; et (3) la simplicité. CONCLUSIONS: Dans cette étude, nous avons identifié les caractéristiques idéales des processus de déclaration des ESP afin de répondre aux besoins du personnel de première ligne et de la direction du département, en fonction des perceptions des pratiques actuelles de déclaration des ESP. L'amélioration des processus de déclaration des ESP a le potentiel d'accroître la déclaration des ESP dans les urgences en général, augmentant ainsi la disponibilité des informations sur les ESP pour soutenir l'amélioration de la qualité et améliorer la sécurité des patients.

Sensitivity and Diagnostic Yield of the First SARS-CoV-2 Nucleic Acid Amplification Test Performed for Patients Presenting to the Hospital.

Importance: Early and accurate diagnostic testing for SARS-CoV-2 is essential to initiate appropriate treatment and infection control and prevention measures among patients presenting to the hospital. Objective: To evaluate the diagnostic sensitivity of the SARS-CoV-2 nucleic acid amplification test (NAAT) performed within 24 hours of arrival to the emergency department among a nationally representative sample of patients. Design, Setting, and Participants: This diagnostic study was conducted at 47 hospitals across 7 provinces in Canada participating in the Canadian COVID-19 Rapid Response Emergency Department Network among consecutive eligible patients presenting to a participating emergency department who were tested for SARS-CoV-2 from March 1, 2020, to December 31, 2021. Patients not tested within 24 hours of arrival and those presenting with a positive result from a test performed in the community were excluded. Main Outcomes and Measures: The primary outcome was a positive result from the SARS-CoV-2 NAAT. Outcome measures were the diagnostic sensitivity and yield of the SARS-CoV-2 NAAT. Results: Of 132 760 eligible patients (66 433 women [50.0%]; median age, 57 years [IQR, 37-74 years]), 17 174 (12.9%) tested positive for SARS-CoV-2 within 14 days of their first NAAT. The diagnostic sensitivity of the SARS-CoV-2 NAAT was 96.2% (17 070 of 17 740 [95% CI, 95.9%-96.4%]) among all of the tests performed. Estimates ranged from a high of 97.7% (1710 of 1751 [95% CI, 96.8%-98.3%]) on day 2 of symptoms to a low of 90.4% (170 of 188 [95% CI, 85.3%-94.2%]) on day 11 of symptoms among patients presenting with COVID-19 symptoms. Among patients reporting COVID-19 symptoms, the sensitivity of the SARS-CoV-2 NAAT was 97.1% (11 870 of 12 225 [95% CI, 96.7%-97.3%]) compared with 87.6% (812 of 927 [95% CI, 85.2%-89.6%]) among patients without COVID-19 symptoms. The diagnostic yield of the SARS-CoV-2 NAAT was 12.0% (18 985 of 158 004 [95% CI, 11.8%-12.2%]) and varied from a high of 20.0% (445 of 2229 [95% CI, 18.3%-21.6%]) among patients tested on day 10 after symptom onset to a low of 8.1% (1686 of 20 719 [95% CI, 7.7%-8.5%]) among patients presenting within the first 24 hours of symptom onset. Conclusions and Relevance: This study suggests that the diagnostic sensitivity was high for the first SARS-CoV-2 NAAT performed in the hospital and did not vary significantly by symptom duration. Repeated testing of patients with negative test results should be avoided unless their pretest probability of disease is high.

Diagnostic yield of screening for SARS-CoV-2 among patients admitted to hospital for alternate diagnoses: an observational cohort study.

OBJECTIVES: To determine the diagnostic yield of screening patients for SARS-CoV-2 who were admitted with a diagnosis unrelated to COVID-19 and to identify risk factors for positive tests. DESIGN: Cohort from the Canadian COVID-19 Emergency Department Rapid Response Network registry. SETTING: 30 acute care hospitals across Canada. PARTICIPANTS: Patients hospitalised for non-COVID-19-related diagnoses who were tested for SARS-CoV-2 between 1 March and 29 December 2020. MAIN OUTCOME: Positive nucleic acid amplification test for SARS-CoV-2. OUTCOME MEASURE: Diagnostic yield. RESULTS: We enrolled 15 690 consecutive eligible adults who were admitted to hospital without clinically suspected COVID-19. Among these patients, 122 tested positive for COVID-19, resulting in a diagnostic yield of 0.8% (95% CI 0.64% to 0.92%). Factors associated with a positive test included presence of fever, being a healthcare worker, having a positive household contact or institutional exposure, and living in an area with higher 7-day average incident COVID-19 cases. CONCLUSIONS: Universal screening of hospitalised patients for COVID-19 across two pandemic waves had a low diagnostic yield and should be informed by individual-level risk assessment in addition to regional COVID-19 prevalence. TRIAL REGISTRATION NUMBER: NCT04702945.