William Osler Health System

Good clinical practice standards mandate that informed consent be obtained before enrollment for all trials that present more than minimal risk to participants. Deferred consent, the process of enrolling patients in a clinical trial before consent is obtained, is sometimes employed in emergency care settings when patients are unable to consent at the time of trial enrollment, are critically ill, and a delay in enrollment would preclude them from potentially benefiting from the trial treatment. This article reviews the risks and benefits associated with the use of deferred consent in randomized controlled trials and the ethical acceptability of its use within specific clinical trial contexts.

Abstract Background We evaluated the analytical performance of four newly developed clinical chemistry assays [Creatinine, Uric Acid, Lactate, Lactate Dehydrogenase (LDH)] on the Abbott Alinity c and ARCHITECT c8000 system. These clinical chemistry assays incorporate a multianalyte calibrator, which has extended stability. For the enzyme assay LDH, both the multianalyte calibrator and a factor calibration are offered. Precision, linearity, method comparison and accuracy were assessed per CLSI guidelines. Sigma metrics were determined to examine the assay variability in relation to allowable performance limits. Methods Precision was assessed by measuring two levels of quality control material (Biorad Chemistry UA) and three pooled patient samples in replicates of five, twice per day, for five days. Method comparison was performed by measuring 134 serum/plasma specimens in duplicate on the new and current Alinity c or ARCHITECT methods. Linearity was evaluated using five to six levels of commercially available linearity material, measured in triplicate. Acceptability criteria were based on the Accreditation Canada Diagnostics (ACD) recommendations. Accuracy was determined in replicates of ten using external NIST standards. For assays where an external standard was not available, calibrators were used. The imprecision and bias from the target value were used to calculate the Sigma value. Total allowable error limits were obtained from the Clinical Laboratory Improvement Amendments (CLIA) and ACD guidelines. Results The results from the precision, accuracy, linearity, and method comparison studies are summarized in the table below. All the next generation chemistry assays demonstrated = 6 Sigma performance on the ARCHITECT and Alinity c systems based on CLIA guidelines. The performance of the factor calibration for the LDH assay was equivalent (data not shown). Conclusion The four next generation clinical chemistry assays (Creatinine2, Uric Acid2, Lactate2, Lactate Dehydrogenase2) demonstrated acceptable performance for precision, accuracy, linearity, and Sigma values on the Alinity c and ARCHITECT system. There was good agreement with the on-market Alinity c and ARCHITECT clinical chemistry assays.

ObjectivesDespite the rise of mHealth applications for inflammatory arthritis, research on patient-reported outcomes related to usability and confidence in disease management is limited. While mHealth tools can improve self-management and patient-provider communication in chronic conditions, their impact on patient empowerment in arthritis remains underexplored. This study aims to address this gap by evaluating the “Arthritis+Patient” mHealth app, focusing on usability, self-management, and empowerment.MethodsThe “Arthritis+Patient” app, developed by Dr. Mulgund from Trillium Health Partners and available for free download, was evaluated through 2 cross-sectional surveys. The first survey, adapted from the Post-Study System Usability Questionnaire, evaluated user experience and was administered to 73 patients diagnosed with inflammatory arthritis by a rheumatologist between January 2019 and January 2024. A second survey on arthritis self-management was administered to 16 patients. We included patients from 3 community rheumatology clinics who consented to survey completion. Data was collected in office, either electronically or on paper, and descriptive statistics were used for analysis. There was some missing data, and denominators were provided accordingly.ResultsAmong the 73 usability survey respondents, 81.9% (n = 59/72) agreed the app’s interface was user-friendly, and 83.5% (n = 61/73) found it easy to understand and navigate. Regarding health management, 69.8% (n = 51/73) found the app useful, and 62.5% (n = 45/72) reported increased confidence in managing their condition. Moreover, 70.8% (n = 51/72) intended to continue using the app, and 72.6% (n = 53/73) would recommend it. Of those who completed the self-management survey (n = 16), 86.7% (n = 13/15) found the educational material useful. App features for tracking medical history, and managing sleep and anxiety were valued by 92.3% (n = 12/13) and 69.2% (n = 9/13) of respondents, respectively. Additionally, 50% (n = 7/14) reported improved tracking of arthritis between appointments, and 28.6% (n = 4/14) felt more confident in decision-making. Most patients (75%, n = 9/12) noted feeling empowered through active symptom tracking and 50% (n = 7/14) used the app 1-2 times per week. Free-text feedback suggested adding trend tracking for symptoms.ConclusionThe “Arthritis+Patient” app shows potential for enhancing patient engagement, empowerment, and self-management in inflammatory arthritis care. Usability and educational content were well-received, with users reporting increased confidence in disease management. Integrating mHealth apps into routine arthritis care could improve patient-centered outcomes and support quality improvement in health services.

The increasing life expectancy and resultant chronic medical comorbidities have resulted in more people requiring palliative care. Unfortunately, palliative care is restricted to marginalized populations, including refugees. In Canada, refugees are only eligible for federal health insurance, which provides basic medical and social coverage until they can obtain provincial health insurance. This study explored limitations in providing palliative care to refugees who had either federal or provincial health insurance in two care settings in Ontario, Canada. An explanatory sequential mixed-methods approach guided the review of local administrative data and interview data to understand palliative care delivery for refugees. Local administrative data from a community health centre and an acute care hospital providing a palliative care approach were collected to review healthcare utilization for refugees with palliative care needs. Interviews from two focus groups with fourteen healthcare providers shared their care experiences in coordinating palliative care for refugees with either federal or provincial health insurance. Refugee patients with palliative care needs appeared to be accessing acute care services frequently to meet their needs over a 5-year period. Due to a lack of citizenship or permanent residency status, many refugees have access to only federal health insurance. Compared to those with routine provincial coverage, federally insured patients were admitted more frequently. Furthermore, healthcare provider experiences revealed that refugees with only federal insurance coverage had significant barriers to accessing community palliative care support, leading to increased reliance on acute care for quality palliative care. This study highlights significant gaps in palliative care access for refugees, especially those with federal health insurance. Equitable access is essential in ensuring that patient-centred, quality palliative care is available to all.

Gastric cancer is common globally and has a generally poor prognosis with a low 5-year survival rate. Targeted therapies and immunotherapies have improved the treatment landscape, providing more options for efficacious treatment. The use of these therapies requires predictive biomarker testing to identify patients who can benefit from their use. New therapies on the horizon, such as CLDN18.2 monoclonal antibody therapy, require laboratories to implement new biomarker tests. A multidisciplinary pan-Canadian expert working group was convened to develop guidance for pathologists and oncologists on the implementation of CLDN18.2 IHC testing for gastric and gastroesophageal junction (G/GEJ) adenocarcinoma in Canada, as well as general recommendations to optimize predictive biomarker testing in G/GEJ adenocarcinoma. The expert working group recommendations highlight the importance of reflex testing for HER2, MMR and/or MSI, CLDN18, and PD-L1 in all patients at first diagnosis of G/GEJ adenocarcinoma. Testing for NTRK fusions may also be included in reflex testing or requested by the treating clinician when third-line therapy is being considered. The expert working group also made recommendations for pre-analytic, analytic, and post-analytic considerations for predictive biomarker testing in G/GEJ adenocarcinoma. Implementation of these recommendations will provide medical oncologists with accurate, timely biomarker results to use for treatment decision-making.

BackgroundMost Canadians receive their care in community hospitals, yet most clinical research is conducted in academic hospitals. This study aims to compare patients with community acquired pneumonia (CAP) treated in academic and community hospitals with respect to their demographics, clinical characteristics, treatments and outcomes.MethodsThis nested observational cohort substudy of the Community Acquired Pneumonia: Toward InnoVAtive Treatment (CAPTIVATE) trial included 1,329 hospitalized adults with CAP recruited between March 1st, 2018 and September 31st, 2023 from 15 Canadian hospitals. Unadjusted and adjusted analyses for age, sex and co-morbidities using logistic, Cox and censored quantile regressions were conducted.ResultsPatients in community hospitals were older (mean [SD] 75.0 [15.7] years vs. 68.3 [16.2] years; p < 0.001), were more likely to be female (49.7% vs. 41.0%, p = 0.002), and had more comorbidities (75.9% vs. 64.8%, p < 0.001). More patients in community hospitals received corticosteroids (49.2% vs. 37.4%, p < 0.001). Community hospital patients had a higher likelihood of developing acute respiratory distress syndrome (OR 3.13, 95% CI: 1.87, 5.24, p = < 0.001), and acute cardiac injury (OR 2.53, 95% CI: 1.33, 4.83, p = 0.005). In unadjusted and adjusted analyses, 28-day mortality difference did not meet statistical significance (OR 1.43, 95% CI: 0.98, 20.7, p = 0.062 and OR 1.23, 95% CI: 0.81, 1.87, p = 0.332, respective).ConclusionPatients with CAP in Canadian community and academic hospitals differed with respect to their age, clinical characteristics, treatments and outcomes, emphasizing the importance of including more community hospitals in clinical research studies to ensure the generalizability of results.

Lung cancer is the leading cause of cancer-related deaths in Canada, with non-small-cell lung cancer (NSCLC) accounting for the majority of cases. Timely access to comprehensive molecular profiling is critical for selecting biomarker-matched targeted therapies, which lead to improved outcomes in advanced NSCLC. Tissue biopsy samples are the gold standard for molecular profiling; however, several challenges can prevent timely and complete molecular profiling from being performed, causing delays in treatment or suboptimal therapy selection. Liquid biopsy offers a minimally invasive method for molecular profiling by analyzing circulating tumour DNA (ctDNA) and RNA (cfRNA) in plasma, potentially overcoming these barriers. This paper discusses the outcomes of a multidisciplinary working group in Ontario, which proposed three eligibility criteria for liquid biopsy reimbursement: (1) insufficient tissue for complete testing or failed tissue biomarker testing; (2) suspected advanced NSCLC where tissue biopsy is not feasible; and (3) high-risk patients who may deteriorate before tissue results are available. The group also addressed considerations for assay selection, implementation, and economic impact. These discussions aim to inform reimbursement and implementation strategies for liquid biopsy in Ontario's public healthcare system, recognizing the need for ongoing evaluation as technology and evidence evolve.