Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic.

Importance: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation. Objectives: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials. Design, Setting, and Participants: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024. Main Outcomes and Measures: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking. Results: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence. Conclusions and Relevance: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

The Diversity of Research Participants in Randomized Controlled Trials and Observational Studies Conducted by the Canadian Critical Care Trials Group.

RATIONALE: Women, older individuals, and racial and ethnic minority groups are often underrepresented in research studies. OBJECTIVES: We evaluated the demographics and diversity of participants enrolled in randomized trials (RCTs) and observational studies published by investigators in association with the Canadian Critical Care Trials Group (CCCTG). METHODS: Quantitative content analysis of peer reviewed RCTs and observational studies from December 1994 to December 2022. For each publication, we extracted participant demographic variables, including sex/gender, age, race or ethnicity, sexual orientation, pregnancy status, language proficiency, income/financial status, housing, education, disability, and geography. RESULTS: 120 publications (28 RCTs, 92 observational studies) enrolled 211,144 participants. Most (107/120, 89.2%) were multicenter studies, and 70% (84/120) were conducted exclusively in Canadian centers; 77.5% (93/120) studies enrolled adult participants, and 19.2% (23/120) enrolled pediatric participants. All studies reported participant mean or median age, 118 (98.3%) reported binary sex or gender, and 9 (7.5%) reported race or ethnicity. No justification was provided in 35 studies which listed pregnancy as an exclusion. There was infrequent reporting of housing (N=4), employment (N=2), income (N=2), and education (N=1). No studies reported language proficiency, sexual orientation, disability or geography of participants. Of the studies reporting gender, women/girls comprised 42.3% participants (range 8.9 to 67.7%). Within 9 studies reporting race or ethnicity of 2950 participants, 59.7% were white, 8% South Asian, 7% Indigenous, 3% Asian, 1% Black, 14% unknown, and 6% 'Other'. CONCLUSIONS: Research publications from the CCCTG infrequently report important participant demographics, and diversity of research participants is disproportionate compared to Canadian societal demographics.

Association between immigration status and total knee arthroplasty outcomes in Ontario, Canada: a population-based matched cohort study.

BACKGROUND: Immigrants and refugees face unique challenges navigating the health care system to manage severe arthritis, because of unfamiliarity, lack of awareness of surgical options, or access. The purpose of this study was to assess total knee arthroplasty (TKA) uptake, surgical outcomes, and hospital utilization among immigrants and refugees compared with Canadian-born patients. METHODS: We included all adults undergoing primary TKA from January 2011 to December 2020 in Ontario. Cohorts were defined as Canadian-born or immigrants and refugees. We assessed change in yearly TKA utilization for trend. We compared differences in 1-year revision, infection rates, 30-day venous thromboembolism (VTE), presentation to emergency department, and hospital readmission between matched Canadian-born and immigrant and refugee groups. RESULTS: We included 158 031 TKA procedures. A total of 11 973 (7.6%) patients were in the immigrant and refugee group, and 146 058 (92.4%) patients were in the Canadian-born group. The proportion of TKAs in Ontario performed among immigrants and refugees nearly doubled over the 10-year study period (p < 0.001). After matching, immigrants were at relatively lower risk of 1-year revision (0.9% v. 1.6%, p < 0.001), infection (p < 0.001), death (p = 0.004), and surgical complications (p < 0.001). No differences were observed in rates of 30-day VTE or length of hospital stay. Immigrants were more likely to be discharged to rehabilitation (p < 0.001) and less likely to present to the emergency department (p < 0.001) than Canadian-born patients. CONCLUSION: Compared with Canadian-born patients, immigrants and refugees have favourable surgical outcomes and similar rates of resource utilization after TKA. We observed an underutilization of these procedures in Ontario relative to their proportion of the population. This may reflect differences in perceptions of chronic pain or barriers accessing arthroplasty.

Beliefs of physician directors on the management of devastating brain injuries at the Canadian emergency department and intensive care unit interface: a national site-level survey.

PURPOSE: Insufficient evidence-based recommendations to guide care for patients with devastating brain injuries (DBIs) leave patients vulnerable to inconsistent practice at the emergency department (ED) and intensive care unit (ICU) interface. We sought to characterize the beliefs of Canadian emergency medicine (EM) and critical care medicine (CCM) physician site directors regarding current management practices for patients with DBI. METHODS: We conducted a cross-sectional survey of EM and CCM physician directors of adult EDs and ICUs across Canada (December 2022 to March 2023). Our primary outcome was the proportion of respondents who manage (or consult on) patients with DBI in the ED. We conducted subgroup analyses to compare beliefs of EM and CCM physicians. RESULTS: Of 303 eligible respondents, we received 98 (32%) completed surveys (EM physician directors, 46; CCM physician directors, 52). Most physician directors reported participating in the decision to withdraw life-sustaining measures (WLSM) for patients with DBI in the ED (80%, n = 78), but 63% of these (n = 62) said this was infrequent. Physician directors reported that existing neuroprognostication methods are rarely sufficient to support WLSM in the ED (49%, n = 48) and believed that an ICU stay is required to improve confidence (99%, n = 97). Most (96%, n = 94) felt that providing caregiver visitation time prior to WLSM was a valid reason for ICU admission. CONCLUSION: In our survey of Canadian EM and CCM physician directors, 80% participated in WLSM in the ED for patients with DBI. Despite this, most supported ICU admission to optimize neuroprognostication and patient-centred end-of-life care, including organ donation.

RéSUMé: OBJECTIF: L'insuffisance des recommandations fondées sur des données probantes pour guider les soins aux individus atteints de lésions cérébrales dévastatrices rend ces personnes vulnérables à des pratiques incohérentes à la jonction entre le service des urgences et de l'unité de soins intensifs (USI). Nous avons cherché à caractériser les croyances des directeurs médicaux canadiens en médecine d'urgence et médecine de soins intensifs concernant les pratiques de prise en charge actuelles des personnes ayant subi une lésion cérébrale dévastatrice. MéTHODE: Nous avons réalisé un sondage transversal auprès des directeurs médicaux des urgences et des unités de soins intensifs pour adultes du Canada (décembre 2022 à mars 2023). Notre critère d'évaluation principal était la proportion de répondant·es qui prennent en charge (ou jouent un rôle de consultation auprès) des personnes atteintes de lésions cérébrales dévastatrices à l'urgence. Nous avons effectué des analyses en sous-groupes pour comparer les croyances des médecins des urgences et des soins intensifs. RéSULTATS: Sur les 303 personnes répondantes admissibles, 98 (32 %) ont répondu aux sondages (directions médicales des urgences, 46; directions médicales d'USI, 52). La plupart des directeurs médicaux ont déclaré avoir participé à la décision de retirer des traitements de maintien des fonctions vitales (TFMV) pour des patient·es atteint·es de lésions cérébrales dévastatrices à l'urgence (80 %, n = 78), mais 63 % (n = 62) ont déclaré que c'était peu fréquent. Les directions médicales ont indiqué que les méthodes de neuropronostic existantes sont rarement suffisantes pour appuyer le retrait des TMFV à l'urgence (49 %, n = 48) et croyaient qu'un séjour aux soins intensifs était nécessaire pour améliorer leur confiance en ces méthodes (99 %, n = 97). La plupart (96 %, n = 94) estimaient que le fait d'offrir du temps de visite aux personnes soignantes avant le retrait des TMFV était un motif valable d'admission aux soins intensifs. CONCLUSION: Dans le cadre de notre sondage mené auprès des directions médicales des services d'urgence et des USI au Canada, 80 % d'entre elles ont participé au retrait de TMFV à l'urgence pour des patient·es souffrant de lésions cérébrales dévastatrices. Malgré cela, la plupart d'entre elles étaient en faveur d'une admission aux soins intensifs afin d'optimiser le neuropronostic et les soins de fin de vie axés sur les patient·es, y compris le don d'organes.