Process evaluation of two large randomized controlled trials to understand factors influencing family physicians' use of antibiotic audit and feedback reports.

BACKGROUND: Unnecessary antibiotic prescriptions in primary care are common and contribute to antimicrobial resistance in the population. Audit and feedback (A&F) on antibiotic prescribing to primary care can improve the appropriateness of antibiotic prescribing, but the optimal approach is uncertain. We performed two pragmatic randomized controlled trials of different approaches to audit and feedback. The trial results showed that A&F was associated with significantly reducing antibiotic prescribing. Still, the effect size was small, and the modifications to the A&F interventions tested in the trials were not associated with any change. Herein, we report a theory-informed qualitative process evaluation to explore potential mechanisms underlying the observed effects. METHODS: Ontario family physicians in the intervention arms of both trials who were sent A&F letters were invited for one-on-one interviews. Purposive sampling was used to seek variation across interested participants in personal and practice characteristics. Qualitative analysis utilized inductive and deductive techniques informed by the Clinical Performance Feedback Intervention Theory. RESULTS: Modifications to the intervention design tested in the trial did not alter prescribing patterns beyond the changes made in response to the A&F overall for various reasons. Change in antibiotic prescribing in response to A&F depended on whether it led to the formation of specific intentions and whether those intentions translated to particular behaviours. Those without intentions to change tended to feel that their unique clinical context was not represented in the A&F. Those with intentions but without specific actions taken tended to express a lack of self-efficacy for avoiding a prescription in contexts with time constraints and/or without an ongoing patient relationship. Many participants noted that compared to overall prescribing, A&F on antibiotic prescription duration was perceived as new information and easily actionable. CONCLUSION: Our findings indicate that contextual factors, including the types of patients and the setting where they are seen, affect how clinicians react to audit and feedback. These results suggest a need to test tailored feedback reports that reflect the context of how, where, and why physicians prescribe antibiotics so that they might be perceived as more personal and more actionable. TRIAL REGISTRATION: Clinical Trial registration IDs: NCT04594200, NCT05044052.

Systematic scoping review of cluster randomised trials conducted exclusively in low-income and middle-income countries between 2017 and 2022.

OBJECTIVE: Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time. DESIGN: A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. DATA SOURCES: We searched MEDLINE between 1 January 2017 and 17 August 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022. DATA EXTRACTION AND SYNTHESIS: Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year. RESULTS: Among 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time. CONCLUSION: Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.

Home-based exercise prehabilitation to improve disease-free survival and return to intended oncologic treatment after cancer surgery in older adults with frailty: a secondary analysis of a randomized trial.

BACKGROUND: Improving survivorship for patients with cancer and frailty is a priority. We aimed to estimate whether exercise prehabilitation improves disease-free survival and return to intended oncologic treatment for older adults with frailty undergoing cancer surgery. METHODS: We conducted a secondary analysis of the oncologic outcomes of a randomized trial of patients ≥ 60 yr of age with frailty undergoing elective cancer surgery. Participants were randomized either to a supported, home-based exercise program plus nutritional guidance or to usual care. Outcomes for this analysis were one-year disease-free survival and return to intended oncologic treatment. We estimated complier average causal effects to account for intervention adherence. RESULTS: We randomized 204 participants (102 per arm); 182 were included in our modified intention-to-treat population and, of these participants, 171/182 (94%) had complete one-year follow up. In the prehabilitation group, 18/94 (11%) died or experienced cancer recurrence, compared with 19/88 (11%) in the control group (hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.66 to 2.34; P = 0.49). Return to intended oncologic treatment occurred in 24/94 (29%) patients the prehabilitation group vs 20/88 (23%) in the usual care group (HR, 1.53; 95% CI, 0.84 to 2.77; P = 0.16). Complier average causal effects directionally diverged for disease-free survival (HR, 0.91; 95% CI, 0.20 to 4.08; P = 0.90) and increased the point estimate for return to treatment (HR, 2.04; 95% CI, 0.52 to 7.97; P = 0.30), but in both cases the CIs included 1. CONCLUSIONS: Randomization to home-based exercise prehabilitation did not lead to significantly better disease-free survival or earlier return to intended oncologic treatment in older adults with frailty undergoing cancer surgery. Our results could inform future trials powered for more plausible effect sizes, especially for the return to intended oncologic treatment outcome. STUDY REGISTRATION: ClinicalTrials.gov ( NCT02934230 ); first submitted 22 August 2016.

RéSUMé: CONTEXTE: L'amélioration de la survie des personnes atteintes de cancer et de fragilité est une priorité. Nous avons cherché à estimer si la préadaptation physique améliore la survie sans maladie et le retour au traitement oncologique prévu pour les personnes âgées fragiles bénéficiant d'une chirurgie du cancer. MéTHODE: Nous avons effectué une analyse secondaire des issues oncologiques d'une étude randomisée de patient·es âgé·es de 60 ans ou plus atteint·es de fragilité bénéficiant d'une chirurgie carcinologique non urgente. Nous avons randomisé les personnes participantes à un programme d'exercice à domicile accompagné de conseils nutritionnels ou à recevoir les soins habituels. Les critères d'évaluation de cette analyse étaient la survie sans maladie à un an et le retour au traitement oncologique prévu. Nous avons estimé les effets moyens causaux d'observance pour tenir compte de l'adhérence à l'intervention. RéSULTATS: Nous avons randomisé 204 participant·es (102 par bras); 182 personnes ont été incluses dans notre population modifiée en intention de traiter et, parmi ces participant·es, 171/182 (94%) ont fait l'objet d'un suivi complet à un an. Dans le groupe préadaptation, 18/94 (11%) personnes sont décédées ou ont connu une récidive du cancer, contre 19/88 (11 %) dans le groupe témoin (rapport de risque [HR], 1,25; intervalle de confiance [IC] à 95%, 0.66 à 2.34; P = 0.49). Le retour au traitement oncologique prévu a eu lieu chez 24 patient·es sur 94 (29 %) dans le groupe préadaptation vs 20/88 (23 %) dans le groupe de soins habituels (RR, 1.53; IC 95%, 0.84 à 2.77; P = 0.16). Les effets moyens causaux d'observance ont divergé directionnellement pour la survie sans maladie (RR, 0.91; IC 95%, 0.20 à 4.08; P = 0.90) et augmenté l'estimation ponctuelle du retour au traitement (RR, 2.04; IC 95%, 0.52 à 7.97; P = 0.30), mais dans les deux cas, les IC comprenaient 1. CONCLUSION: La randomisation pour la préadaptation physique à domicile n'a pas entraîné d'amélioration significative de la survie sans maladie ou de retour plus précoce au traitement oncologique prévu chez les personnes âgées fragiles bénéficiant d'une chirurgie du cancer. Nos résultats pourraient éclairer de futures études alimentées par des tailles d'effet plus plausibles, en particulier pour le critère de retour prévu au traitement oncologique. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov ( NCT02934230 ); première soumission le 22 août 2016.

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.

Comments, Suggestions and Criticisms of the PRECIS-2 Design Tool: A Citation Analysis.

INTRODUCTION: The Pragmatic Explanatory Continuum Indicator Summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, PRECIS-3. METHODS: We used Web of Science to identify all publication types citing PRECIS-2, published between May 2015 and July 2023. Citations were eligible if they contained 'substantive' suggestions, comments or criticism of the PRECIS-2 tool. We defined 'substantive' as comments explicitly referencing at least one PRECIS-2 domain, or a concept directly linked to an existing or newly proposed domain Two reviewers independently extracted comments, suggestions and criticisms, noting their implications for the update. These were discussed amongst authors to achieve consensus on the interpretation of each comment and its implications for PRECIS-3. RESULTS: The search yielded 885 publications, and after full-text review, 89 articles met the inclusion criteria. Comments pertained to new domains, changes in existing domains, or were relevant across several or all domains. Proposed new domains included assessment of the comparator arm and a domain to describe blinding. There were concerns about scoring eligibility and recruitment domains for cluster trials. Suggested areas for improvement across domains included the need for more scoring guidance for explanatory design choices. DISCUSSION: Published comments recognise PRECIS-2's success in aiding trialists with pragmatic or explanatory design choices. Enhancing its implementation and widespread use will involve adding new domains, refining domain definitions, and addressing overall tool issues. This citation review offers valuable user feedback, pivotal for shaping the upcoming version of the PRECIS tool, PRECIS-3.

Clinician-Prioritized Measures to Use in a Remote Concussion Assessment: Delphi Study.

BACKGROUND: There is little guidance available, and no uniform assessment battery is used in either in-person or remote evaluations of people who are experiencing persistent physical symptoms post concussion. Selecting the most appropriate measures for both in-person and remote physical assessments is challenging because of the lack of expert consensus and guidance. OBJECTIVE: This study used expert consensus processes to identify clinical measures currently used to assess 5 physical domains affected by concussion (neurological examination, cervical spine, vestibular, oculomotor, or effort) and determine the feasibility of applying the identified measures virtually. METHODS: The Delphi approach was used. In the first round, experienced clinicians were surveyed regarding using measures in concussion assessment. In the second round, clinicians reviewed information regarding the psychometric properties of all measures identified in the first round by at least 15% (9/58) of participants. In the second round, experts rank-ordered the measures from most relevant to least relevant based on their clinical experience and documented psychometric properties. A working group of 4 expert clinicians then determined the feasibility of virtually administering the final set of measures. RESULTS: In total, 59 clinicians completed survey round 1 listing all measures they used to assess the physical domains affected by a concussion. The frequency counts of the 146 different measures identified were determined. Further, 33 clinicians completed the second-round survey and rank-ordered 22 measures that met the 15% cutoff criterion retained from round 1. Measures ranked first were coordination, range of motion, vestibular ocular motor screening, and smooth pursuits. These measures were feasible to administer virtually by the working group members; however, modifications for remote administration were recommended, such as adjusting the measurement method. CONCLUSIONS: Clinicians ranked assessment of coordination (finger-to-nose test and rapid alternating movement test), cervical spine range of motion, vestibular ocular motor screening, and smooth pursuits as the most relevant measures under their respective domains. Based on expert opinion, these clinical measures are considered feasible to administer for concussion physical examinations in the remote context, with modifications; however, the psychometric properties have yet to be explored. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/40446.

Family-centred care interventions for children with chronic conditions: A scoping review.

INTRODUCTION: Children with chronic conditions have greater health care needs than the general paediatric population but may not receive care that centres their needs and preferences as identified by their families. Clinicians and researchers are interested in developing interventions to improve family-centred care need information about the characteristics of existing interventions, their development and the domains of family-centred care that they address. We conducted a scoping review that aimed to identify and characterize recent family-centred interventions designed to improve experiences with care for children with chronic conditions. METHODS: We searched Medline, Embase, PsycInfo and Cochrane databases, and grey literature sources for relevant articles or documents published between 1 January 2019 and 11 August 2020 (databases) or 7-20 October 2020 (grey literature). Primary studies with ≥10 participants, clinical practice guidelines and theoretical articles describing family-centred interventions that aimed to improve experiences with care for children with chronic conditions were eligible. Following citation and full-text screening by two reviewers working independently, we charted data covering study characteristics and interventions from eligible reports and synthesized interventions by domains of family-centred care. RESULTS: Our search identified 2882 citations, from which 63 articles describing 61 unique interventions met the eligibility criteria and were included in this review. The most common study designs were quasiexperimental studies (n = 18), randomized controlled trials (n = 11) and qualitative and mixed-methods studies (n = 9 each). The most frequently addressed domains of family-centred care were communication and information provision (n = 45), family involvement in care (n = 37) and access to care (n = 30). CONCLUSION: This review, which identified 61 unique interventions aimed at improving family-centred care for children with chronic conditions across a range of settings, is a concrete resource for researchers, health care providers and administrators interested in improving care for this high-needs population. PATIENT OR PUBLIC CONTRIBUTION: This study was co-developed with three patient partner co-investigators, all of whom are individuals with lived experiences of rare chronic diseases as parents and/or patients and have prior experience in patient engagement in research (I. J., N. P., M. S.). These patient partner co-investigators contributed to this study at all stages, from conceptualization to dissemination.

The HEARTRISK6 Scale: Predicting Short-Term Serious Outcomes in Emergency Department Acute Heart Failure Patients.

Background: Acute heart failure (AHF) is a common emergency department (ED) presentation that may have poor outcomes but often does not require hospital admission. There is little evidence to guide dispositional decisions. Objectives: The authors sought to create a risk score for predicting short-term serious outcomes (SSO) in patients with AHF. Methods: We pooled data from 3 prospective cohorts: 2 published studies and 1 new cohort. The 3 cohorts prospectively enrolled patients who required treatment for AHF at 10 tertiary care hospital EDs. The primary outcome was SSO, defined as death <30 days, intubation or noninvasive ventilation (NIV), myocardial infarction, or relapse to ED <14 days. The logistic regression model evaluated 13 predictors, used an AIC-based step-down procedure, and bootstrapped internal validation. Results: Of the 2,246 patients in the 3 cohorts (N = 559; 1,100; 587), the mean age was 77.4 years, 54.5% were male, 3.1% received intravenous nitroglycerin, 5.2% received ED NIV, and 48.6% were admitted to the hospital. There were 281 (12.5%) SSOs including 70 deaths (3.1%) with many in discharged patients. The final HEARTRISK6 Scale included 6 variables: valvular heart disease, tachycardia, need for NIV, creatinine, troponin, and failed reassessment (walk test). Choosing HEARTRISK6 total-point admission thresholds of ≥1 or ≥2 would yield, respectively, sensitivities of 88.3% (95% CI: 83.9%-91.8%) and 71.5% (95% CI: 65.9%-76.7%) and specificities of 24.7% (95% CI: 22.8%-26.7%) and 50.1% (95% CI: 47.9%-52.4%) for SSO. Conclusions: Using 3 large prospectively collected datasets, we created a concise and sensitive risk scale for patients with AHF in the ED. Implementation of the HEARTRISK6 scale could lead to safer and more efficient disposition decisions.

Derivation of a clinical prediction score for the diagnosis of clinically significant symptomatic carotid artery disease.

OBJECTIVES: Emergent vascular imaging identifies a subset of patients requiring immediate specialized care (i.e. carotid stenosis > 50%, dissection or free-floating thrombus). However, most TIA patients do not have these findings, so it is inefficient to image all TIA patients in crowded emergency departments (ED). Our objectives were to derive and internally validate a clinical prediction score for clinically significant carotid artery disease in TIA patients. METHODS: This was a planned secondary analysis of a prospective cohort study from 14 Canadian EDs. Among 11555 consecutive adult ED patients with TIA/minor stroke symptoms over 12 years, 9882 had vascular imaging and were included in the analysis. Our main outcome was clinically significant carotid artery disease, defined as extracranial internal carotid stenosis ≥ 50%, dissection, or thrombus in the internal carotid artery, with contralateral symptoms. RESULTS: Of 9882 patients, 888 (9.0%) had clinically significant carotid artery disease. Logistic regression was used to derive a 13-variable reduced model. We simplified the model into a score (Symcard [Symptomatic carotid artery disease] Score), with suggested cut-points for high, medium, and low-risk stratification. A substantial portion (38%) of patients were classified as low-risk, 33.8% as medium risk, and 28.2% as high risk. At the low-risk cut-point, sensitivity was 92.9%, specificity 41.1%, and diagnostic yield 1.7%. CONCLUSIONS: This simple score can predict carotid artery disease in TIA patients using readily available information. It identifies low-risk patients who can defer vascular imaging to an outpatient or specialty clinic setting. Medium-risk patients may undergo imaging immediately or with slight delay, depending on local resources. High-risk patients should undergo urgent vascular imaging.

RéSUMé: OBJECTIFS: L'imagerie vasculaire émergente permet d'identifier un sous-ensemble de patients nécessitant des soins spécialisés immédiats (c.-à-d. sténose carotidienne >50 %, dissection ou thrombus flottant). Cependant, la plupart des patients atteints de RTI ne présentent pas ces résultats, il est donc inefficace d'effectuer une imagerie de tous les patients atteints de RTI dans les services d'urgence (ER) surpeuplés. Nos objectifs étaient de calculer et de valider en interne un score de prédiction clinique pour la maladie carotide cliniquement significative chez les patients atteints d'une AIT MéTHODES: Il s'agissait d'une analyse secondaire planifiée d'une étude de cohorte prospective menée auprès de 14 DE canadiens. Parmi les 11555 patients adultes consécutifs atteints d'un EI présentant des symptômes d'AIT/AVC mineur au cours des 12 dernières années, 9882 ont reçu une imagerie vasculaire et ont été inclus dans l'analyse. Notre principal critère de jugement était la maladie carotide cliniquement significative, définie comme une sténose extracrânienne de la carotide interne à 50 %, une dissection ou un thrombus dans l'artère carotide interne, avec des symptômes contralatéraux. RéSULTATS: Sur 9882 patients, 888 (9,0 %) présentaient une maladie de l'artère carotide cliniquement significative. La régression logistique a été utilisée pour obtenir un modèle réduit à 13 variables. Nous avons simplifié le modèle en un score (Symcard [Symptomatic carotid artery disease] Score), avec des points de coupure suggérés pour la stratification à risque élevé, moyen et faible. Une proportion importante (38,0 %) des patients ont été classés à faible risque, 33,8 % à risque moyen et 28,2 % à risque élevé. Au seuil de faible risque, la sensibilité était de 92,9 %, la spécificité de 41,1 % et le rendement diagnostique de 1,7 %. CONCLUSIONS: Ce score simple permet de prédire la maladie de l'artère carotide chez les patients atteints d'AIT en utilisant des informations facilement disponibles. Il identifie les patients à faible risque qui peuvent reporter l'imagerie vasculaire à un établissement de consultation externe ou de spécialité. Les patients à risque moyen peuvent subir une imagerie immédiatement ou avec un léger délai, selon les ressources locales. Les patients à haut risque doivent subir une imagerie vasculaire urgente.

Utility of serial troponin testing for emergency department patients with syncope.

BACKGROUND: For emergency department (ED) patients with syncope, cardiac troponin can identify acute coronary syndrome (ACS) and prognosticate for 30-day serious adverse events. However, it is unclear if serial testing improves diagnostic yield and prognostication. METHODS: This was a secondary analysis of data from two prospective studies conducted to develop the Canadian Syncope Risk Score. Adults (age ≥ 16 years) with syncope were enrolled, and patient characteristics, vital signs, physician diagnostic impression, electrocardiogram and troponin results, and adjudicated 30-day serious adverse event were collected. The primary outcome was the detection of a serious adverse event within 30 days of ED disposition. The secondary outcome was comparison of ED length of stay among patients with single versus serial troponin measurements. RESULTS: 4996 patients [mean age 64.5 (SD 18.8) years, 52.2% male] were included: 4397 (89.8%) with single troponin [232 (5.3%) with serious adverse event in the ED and 203 (4.6%) after ED disposition]; 499 (10.2%) patients with > 1 troponin measurement [39 (7.8%) with serious adverse event in ED and 60 (12.0%) after ED disposition]. Among those with serial measurements, 10 patients (2.0%) had a rise from below to above the 99th percentile threshold, of whom 4 patients (0.8%) suffered serious adverse event: two with arrhythmias diagnosed on electrocardiogram, one with ACS and one suffered respiratory failure. Nine patients (1.8%) had Canadian Syncope Risk Score risk reclassification based on serial measurement, and none suffered 30-day serious adverse event. Median ED length of stay was significantly longer for patients with serial testing (5.6 vs. 3.8 h, p < 0.001). CONCLUSIONS: The initial troponin measurement was sufficient for serious adverse event detection and in-ED risk stratification. Serial troponin testing does not improve the diagnostic yield or prognostication and should be reserved for patients with ongoing symptoms or electrocardiogram findings suggestive of cardiac ischemia.

ABSTRAIT: CONTEXTE: Pour les patients du service des urgences (DE) atteints de syncope, la troponine cardiaque peut identifier le syndrome coronarien aigu (SCA) et le pronostic pour les événements indésirables graves de 30 jours. Cependant, il n'est pas clair si les tests en série améliorent le rendement diagnostique et le pronostic. MéTHODES: Il s'agissait d'une analyse secondaire des données de deux études prospectives menées pour élaborer le Canadian Syncope Risk Score. Des adultes (âgés de 16 ans) atteints de syncope ont été recrutés, et les caractéristiques du patient, les signes vitaux, l'empreinte diagnostique du médecin, les résultats de l'électrocardiogramme et de la troponine, ainsi que les événements indésirables graves évalués à 30 jours ont été recueillis. Le critère de jugement principal était la détection d'un événement indésirable grave dans les 30 jours suivant la décision de l'urgence. Le critère de jugement secondaire était la comparaison de la durée de séjour à l'urgence chez les patients ayant une seule mesure de troponine par rapport à la mesure en série. RéSULTATS: 4 996 patients [âge moyen 64,5 (ET 18,8) ans, 52,2 % d'hommes] ont été inclus : 4 397 (89,8 %) avec une seule troponine [232 (5,3 %) avec un événement indésirable grave à l'urgence et 203 (4,6 %) après l'urgence]; 499 (10,2 %) patients avec > 1 mesure de la troponine [39 (7,8 %) avec événement indésirable grave à l'urgence et 60 (12,0 %) après la décision à l'urgence]. Parmi les patients ayant fait l'objet de mesures en série, 10 (2,0 %) présentaient une augmentation du seuil inférieur à supérieur au seuil du 99e percentile, dont 4 (0,8 %) ont subi un événement indésirable grave : deux avec arythmies diagnostiquées par électrocardiogramme, un avec SCA et un avec insuffisance respiratoire. Neuf patients (1,8 %) ont présenté une reclassification du risque selon le score canadien de risque de syncope en fonction de la mesure en série, et aucun n'a subi d'événement indésirable grave de 30 jours. La durée médiane de séjour aux urgences était significativement plus longue pour les patients ayant subi des tests en série (5,6 vs. 3,8 heures, p < 0,001). CONCLUSIONS: La mesure initiale de la troponine était suffisante pour la détection des effets indésirables graves et la stratification des risques aux urgences. Les tests de troponine en série n'améliorent pas le rendement diagnostique ou le pronostic et doivent être réservés aux patients présentant des symptômes continus ou des résultats d'électrocardiogramme suggérant une ischémie cardiaque.

Reliability and Sensitivity of a Virtual Assessment Developed for Workplace Concussions: Protocol for a Method-Comparison Study.

BACKGROUND: Workplace mild traumatic brain injuries are frequently associated with persistent symptoms, leading to a reduction in productivity at work or even disability. People who sustain workplace injuries frequently need rehabilitation and support, and the challenges of delivering these services was heightened during the COVID-19 pandemic as injured workers had to be cared for remotely. Currently, clinicians are conducting both in-person and virtual (remote) concussion assessments; however, the measures that are being used to complete these assessments have undocumented psychometric properties. OBJECTIVE: This study will document the psychometric properties of the clinical measures that are being used remotely and their ability to produce similar results to in-person assessments. Specifically, through this method-comparison study, we aim to (1) evaluate the sensitivity of the measures included in a virtual assessment toolkit when compared to an in-person assessment and (2) determine the interrater and intrarater reliabilities of the measures included in a virtual assessment toolkit. METHODS: Patient participants (people living with acquired brain injuries) will attend two assessments (in person and virtual) at the Ottawa Hospital. The two assessments will be identical, consisting of the measures included in our previously developed virtual concussion assessment toolkit, which includes finger-to-nose testing, the Vestibular/Ocular Motor Screening tool, balance testing, cervical spine range of motion, saccades testing, and evaluation of effort. All virtual assessments will occur using the Microsoft Teams platform and will be audio/video-recorded. The clinician assessor and patient participant will complete a feedback form following completion of the assessments. A different clinician will also document the findings on observed videos of the virtual assessment shortly after completion of both in-person and virtual assessments and approximately 1 month later. Interrater reliability will be assessed by comparing the second clinician's observation with the first clinician's initial virtual assessment. Intrarater reliability will be evaluated by comparing the second clinician's observation with their own assessment approximately 1 month later. Sensitivity will be documented by comparing the findings (identification of abnormality) of the in-person assessment completed by the initial clinician assessor with those of the second clinician assessor on the observation of the recording of the virtual assessment. RESULTS: As of May 2024, we have recruited 7 clinician assessors and completed study assessments with 39 patient participants. The study recruitment is expected to be completed by September 2024. CONCLUSIONS: Currently, it is unknown if completing concussion assessments virtually produces similar results to the in-person assessment. This work will serve as a first step to determining the similarity of the virtual assessment to the matching in-person assessment and will provide information on the reliability of the virtual assessment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57663.

Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial.

OBJECTIVES: To evaluate whether providing family physicians with feedback on their antibiotic prescribing compared with that of their peers reduces antibiotic prescriptions. To also identify effects on antibiotic prescribing from case-mix adjusted feedback reports and messages emphasising antibiotic associated harms. DESIGN: Pragmatic, factorial randomised controlled trial. SETTING: Primary care physicians in Ontario, Canada PARTICIPANTS: All primary care physicians were randomly assigned a group if they were eligible and actively prescribing antibiotics to patients 65 years or older. Physicians were excluded if had already volunteered to receive antibiotic prescribing feedback from another agency, or had opted out of the trial. INTERVENTION: A letter was mailed in January 2022 to physicians with peer comparison antibiotic prescribing feedback compared with the control group who did not receive a letter (4:1 allocation). The intervention group was further randomised in a 2x2 factorial trial to evaluate case-mix adjusted versus unadjusted comparators, and emphasis, or not, on harms of antibiotics. MAIN OUTCOME MEASURES: Antibiotic prescribing rate per 1000 patient visits for patients 65 years or older six months after intervention. Analysis was in the modified intention-to-treat population using Poisson regression. RESULTS: 5046 physicians were included and analysed: 1005 in control group and 4041 in intervention group (1016 case-mix adjusted data and harms messaging, 1006 with case-mix adjusted data and no harms messaging, 1006 unadjusted data and harms messaging, and 1013 unadjusted data and no harms messaging). At six months, mean antibiotic prescribing rate was 59.4 (standard deviation 42.0) in the control group and 56.0 (39.2) in the intervention group (relative rate 0.95 (95% confidence interval 0.94 to 0.96). Unnecessary antibiotic prescribing (0.89 (0.86 to 0.92)), prolonged duration prescriptions defined as more than seven days (0.85 (0.83 to 0.87)), and broad spectrum prescribing (0.94 (0.92 to 0.95)) were also significantly lower in the intervention group compared with the control group. Results were consistent at 12 months post intervention. No significant effect was seen for including emphasis on harms messaging. A small increase in antibiotic prescribing with case-mix adjusted reports was noted (1.01 (1.00 to 1.03)). CONCLUSIONS: Peer comparison audit and feedback letters significantly reduced overall antibiotic prescribing with no benefit of case-mix adjustment or harms messaging. Antibiotic prescribing audit and feedback is a scalable and effective intervention and should be a routine quality improvement initiative in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04594200.

Temporal Trends in Gestational Diabetes Mellitus and Associated Risk Factors in Ontario, Canada, 2012-2020: A Population-Based Cohort Study.

OBJECTIVES: The prevalence of gestational diabetes mellitus (GDM) has been increasing globally over recent decades; however, underlying reasons for the increase remain unclear. We analyzed trends in GDM rates and evaluated risk factors associated with the observed trends in Ontario, Canada. METHODS: We conducted a retrospective population-based cohort study using the Better Outcomes Registry and Network Ontario, linked with the Canadian Institute for Health Information Discharge Abstract Database. All pregnant individuals who had a singleton hospital delivery from 1 April 2012 to 31 March 2020 were included. We calculated rates and 95% CIs for GDM by year of delivery and contrasted fiscal year 2019/20 with 2012/13. Temporal trends in GDM were quantified using crude and adjusted risk ratios by modified Poisson regression. We further quantified the temporal increase attributable to changes in maternal characteristics by decomposition analysis. RESULTS: Among 1 044 258 pregnant individuals, 82 896 (7.9%) were diagnosed with GDM over the 8 years. GDM rate rose from 6.1 to 10.4 per 100 deliveries between fiscal years 2012/13 and 2019/20. The risk of GDM in 2019/20 was 1.53 times (95% CI 1.50-1.56) higher compared with 2012/13. 27% of the increase in GDM was due to changes in maternal age, 8 BMI, and Asian ethnicity. CONCLUSIONS: The GDM rate has been consistently increasing in Ontario, Canada. The contribution of increasing maternal age, pre-pregnancy obesity, and Asian ethnicity to the recent increase in GDM is notable. Further investigation is required to better understand the contributors to increasing GDM.

A Population-Based Matched Cohort Study of Digestive System Cancer Incidence and Mortality in Individuals With and Without Inflammatory Bowel Disease.

INTRODUCTION: To study digestive system cancer risks in individuals with inflammatory bowel diseases (IBDs) in the biologic era. METHODS: We used population-level administrative and cancer registry data from Ontario, Canada, (1994-2020) to compare people with IBD to matched controls (1:10 by sex and birth year) on trends in age-sex standardized cancer incidence and risk ratios of incident cancers and cancer-related deaths. RESULTS: Among 110,919 people with IBD and 1,109,190 controls, colorectal cancer incidence (per 100,000 person-years) declined similarly in people with ulcerative colitis (average annual percentage change [AAPC] -1.81; 95% confidence interval [CI] -2.48 to -1.156) and controls (AAPC -2.79; 95% CI -3.44 to -2.14), while small bowel cancer incidence rose faster in those with Crohn's disease (AAPC 9.68; 95% CI 2.51-17.3) than controls (AAPC 3.64; 95% CI 1.52-5.80). Extraintestinal digestive cancer incidence rose faster in people with IBD (AAPC 3.27; 95% CI 1.83-4.73) than controls (AAPC -1.87; 95% CI -2.33 to -1.42), particularly for liver (IBD AAPC 8.48; 95% CI 4.11-13.1) and bile duct (IBD AAPC 7.22; 95% CI 3.74-10.8) cancers. Beyond 2010, the incidences (and respective mortality rates) of colorectal (1.60; 95% CI 1.46-1.75), small bowel (4.10; 95% CI 3.37-4.99), bile duct (2.33; 95% CI 1.96-2.77), and pancreatic (1.19; 95% CI 1.00-1.40) cancers were higher in people with IBD. DISCUSSION: Cancer incidence is declining for colorectal cancer and rising for other digestive cancers in people with IBD. Incidence and mortality remain higher in people with IBD than controls for colorectal, small bowel, bile duct, and pancreatic cancers.

Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury.

BACKGROUND: The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear. METHODS: We randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months. RESULTS: A total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively. CONCLUSIONS: In critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.).

Maintaining the validity of inference from linear mixed models in stepped-wedge cluster randomized trials under misspecified random-effects structures.

Linear mixed models are commonly used in analyzing stepped-wedge cluster randomized trials. A key consideration for analyzing a stepped-wedge cluster randomized trial is accounting for the potentially complex correlation structure, which can be achieved by specifying random-effects. The simplest random effects structure is random intercept but more complex structures such as random cluster-by-period, discrete-time decay, and more recently, the random intervention structure, have been proposed. Specifying appropriate random effects in practice can be challenging: assuming more complex correlation structures may be reasonable but they are vulnerable to computational challenges. To circumvent these challenges, robust variance estimators may be applied to linear mixed models to provide consistent estimators of standard errors of fixed effect parameters in the presence of random-effects misspecification. However, there has been no empirical investigation of robust variance estimators for stepped-wedge cluster randomized trials. In this article, we review six robust variance estimators (both standard and small-sample bias-corrected robust variance estimators) that are available for linear mixed models in R, and then describe a comprehensive simulation study to examine the performance of these robust variance estimators for stepped-wedge cluster randomized trials with a continuous outcome under different data generators. For each data generator, we investigate whether the use of a robust variance estimator with either the random intercept model or the random cluster-by-period model is sufficient to provide valid statistical inference for fixed effect parameters, when these working models are subject to random-effect misspecification. Our results indicate that the random intercept and random cluster-by-period models with robust variance estimators performed adequately. The CR3 robust variance estimator (approximate jackknife) estimator, coupled with the number of clusters minus two degrees of freedom correction, consistently gave the best coverage results, but could be slightly conservative when the number of clusters was below 16. We summarize the implications of our results for the linear mixed model analysis of stepped-wedge cluster randomized trials and offer some practical recommendations on the choice of the analytic model.