Browsing by Author "Turgeon, Alexis F"
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Item Open Access Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial(2021-05-04) Bégin, Philippe; Callum, Jeannie; Heddle, Nancy M; Cook, Richard; Zeller, Michelle P; Tinmouth, Alan; Fergusson, Dean A; Cushing, Melissa M; Glesby, Marshall J; Chassé, Michaël; Devine, Dana V; Robitalle, Nancy; Bazin, Renée; Shehata, Nadine; Finzi, Andrés; McGeer, Allison; Scales, Damon C; Schwartz, Lisa; Turgeon, Alexis F; Zarychanski, Ryan; Daneman, Nick; Carl, Richard; Amorim, Luiz; Gabe, Caroline; Ellis, Martin; Sachais, Bruce S; Loftsgard, Kent C; Jamula, Erin; Carruthers, Julie; Duncan, Joanne; Lucier, Kayla; Li, Na; Liu, Yang; Armali, Chantal; Kron, Amie; Modi, Dimpy; Auclair, Marie-Christine; Cerro, Sabrina; Avram, Meda; Arnold, Donald MAbstract Background Convalescent plasma has been used for numerous viral diseases including influenza, severe acute respiratory syndrome, Middle East respiratory syndrome and Ebola virus; however, evidence to support its use is weak. SARS-CoV-2 is a novel coronavirus responsible for the 2019 global pandemic of COVID-19 community acquired pneumonia. We have undertaken a randomized controlled trial to assess the efficacy and safety of COVID-19 convalescent plasma (CCP) in patients with SARS-CoV-2 infection. Methods CONCOR-1 is an open-label, multicentre, randomized trial. Inclusion criteria include the following: patients > 16 years, admitted to hospital with COVID-19 infection, receiving supplemental oxygen for respiratory complications of COVID-19, and availability of blood group compatible CCP. Exclusion criteria are : onset of respiratory symptoms more than 12 days prior to randomization, intubated or imminent plan for intubation, and previous severe reactions to plasma. Consenting patients are randomized 2:1 to receive either approximately 500 mL of CCP or standard of care. CCP is collected from donors who have recovered from COVID-19 and who have detectable anti-SARS-CoV-2 antibodies quantified serologically. The primary outcome is intubation or death at day 30. Secondary outcomes include ventilator-free days, length of stay in intensive care or hospital, transfusion reactions, serious adverse events, and reduction in SARS-CoV-2 viral load. Exploratory analyses include patients who received CCP containing high titre antibodies. A sample size of 1200 patients gives 80% power to detect a 25% relative risk reduction assuming a 30% baseline risk of intubation or death at 30 days (two-sided test; α = 0.05). An interim analysis and sample size re-estimation will be done by an unblinded independent biostatistician after primary outcome data are available for 50% of the target recruitment (n = 600). Discussion This trial will determine whether CCP will reduce intubation or death non-intubated adults with COVID-19. The trial will also provide information on the role of and thresholds for SARS-CoV-2 antibody titres and neutralization assays for donor qualification. Trial registration Clinicaltrials.gov NCT04348656 . Registered on 16 April 2020.Item Open Access Impact of trauma system structure on injury outcomes: a systematic review protocol(2017-01-21) Moore, Lynne; Champion, Howard; O’Reilly, Gerard; Leppaniemi, Ari; Cameron, Peter; Palmer, Cameron; Abu-Zidan, Fikri M; Gabbe, Belinda; Gaarder, Christine; Yanchar, Natalie; Stelfox, Henry T; Coimbra, Raul; Kortbeek, John; Noonan, Vanessa; Gunning, Amy; Leenan, Luke; Gordon, Malcolm; Khajanchi, Monty; Shemilt, Michèle; Porgo, Valérie; Turgeon, Alexis FAbstract Background Injury represents one of the greatest public health challenges of our time with over 5 million deaths and 100 million people temporarily or permanently disabled every year worldwide. The effectiveness of trauma systems in decreasing injury mortality and morbidity has been well demonstrated. However, the organisation of trauma care varies significantly across trauma systems and we know little about which components of trauma systems contribute to their effectiveness. The objective of the study described in this protocol is to systematically review evidence of the impact of trauma system components on clinically significant outcomes including mortality, function and disability, quality of life, and resource utilization. Methods We will perform a systematic review of studies evaluating the association between at least one trauma system component (e.g. accreditation by a central agency, interfacility transfer agreements) and at least one injury outcome (e.g. mortality, disability, resource use). We will search MEDLINE, EMBASE, COCHRANE central, and BIOSIS/Web of Knowledge databases, thesis holdings, key injury organisation websites and conference proceedings for eligible studies. Pairs of independent reviewers will evaluate studies for eligibility and extract data from included articles. Methodological quality will be evaluated using elements of the ROBINS-I tool and the Cochrane risk of bias tool for non-randomized and randomized studies, respectively. Strength of evidence will be evaluated using the GRADE tool. Discussion We expect to advance knowledge on the components of trauma systems that contribute to their effectiveness. This may lead to recommendations on trauma system structure that will help policy-makers make informed decisions as to where resources should be focused. The review may also lead to specific recommendations for future research efforts. Systematic review registration This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 28-06-2016. PROSPERO 2016:CRD42016041336 Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42016041336 .Item Open Access Key stakeholders’ views on the quality of care and services available to frail seniors in Canada(2018-11-26) Giguere, Anik M C; Farmanova, Elina; Holroyd-Leduc, Jayna M; Straus, Sharon E; Urquhart, Robin; Carnovale, Valerie; Breton, Erik; Guo, Selynne; Maharaj, Nandini; Durand, Pierre J; Légaré, France; Turgeon, Alexis F; Aubin, MichèleAbstract Background Frail seniors often receive ineffective care, which does not meet their needs. It is still unclear how healthcare systems should be redesigned to be more sensitive to the needs and values of frail seniors and their caregivers. We thus aimed to describe key stakeholders’ perspectives on the current healthcare and services available to frail seniors. Methods In this qualitative descriptive study, we conducted semi-structured interviews with a convenience sample of 42 frail seniors, caregivers, clinicians, or healthcare administrators/decision makers involved in frail senior care from five Canadian provinces. We explored participants’ perspectives on the quality of care and services for frail seniors. We used an inductive/deductive thematic data analysis approach based on the Square-of-Care model, including emerging themes using the constant comparison method. Results We grouped participants’ perspectives into strengths, weaknesses and opportunities for improvement, and then into nine themes: care processes, continuity of care, social frailty, access to healthcare and services, models of healthcare delivery, cost of care, healthcare staff management and professional development of healthcare providers, material resources and environmental design of healthcare facilities, and coordination of care. Our findings suggest redesigning assessment, communication with frail seniors and their caregivers, targeting care and services to the needs, and integrating care better across settings and in time. Conclusions A systematic identification of frail older people is the first step to adapt healthcare systems to this population’s needs. Participation of frail older people and their caregivers to decision making would also allow choosing care plans meeting their care goals. The integration of care and services across settings, over time, and with various providers, is also needed to meet frail senior needs.Item Open Access Transfers from intensive care unit to hospital ward: a multicentre textual analysis of physician progress notes(2018-01-28) Brown, Kyla N; Leigh, Jeanna P; Kamran, Hasham; Bagshaw, Sean M; Fowler, Rob A; Dodek, Peter M; Turgeon, Alexis F; Forster, Alan J; Lamontagne, Francois; Soo, Andrea; Stelfox, Henry TAbstract Background Little is known about documentation during transitions of patient care between clinical specialties. Therefore, we examined the focus, structure and purpose of physician progress notes for patients transferred from the intensive care unit (ICU) to hospital ward to identify opportunities to improve communication breaks. Methods This was a prospective cohort study in ten Canadian hospitals. We analyzed physician progress notes for consenting adult patients transferred from a medical-surgical ICU to hospital ward. The number, length, legibility and content of notes was counted and compared across care settings using mixed-effects linear regression models accounting for clustering within hospitals. Qualitative content analyses were conducted on a stratified random sample of 32 patients. Results A total of 447 patient medical records that included 7052 progress notes (mean 2.1 notes/patient/day 95% CI 1.9–2.3) were analyzed. Notes written by the ICU team were significantly longer than notes written by the ward team (mean lines of text 21 vs. 15, p < 0.001). There was a discrepancy between documentation of patient issues in the last ICU and first ward notes; mean agreement of patient issues was 42% [95% CI 31–53%]. Qualitative analyses identified eight themes related to focus (central point – e.g., problem list), structure (organization, – e.g., note-taking style), and purpose (intention – e.g., documentation of patient course) of the notes that varied across clinical specialties and physician seniority. Conclusions Important gaps and variations in written documentation during transitions of patient care between ICU and hospital ward physicians are common, and include discrepancies in documentation of patient information.