Raphael Saginur

• Chair at Ottawa Hospital Research Institute

Introduction More than 3 years into the pandemic, there is persisting uncertainty as to the etiology, biomarkers, and risk factors of Post COVID-19 Condition (PCC). Serological research data remain a largely untapped resource. Few studies have investigated the potential relationships between post-acute serology and PCC, while accounting for clinica...

Background Predictors of COVID-19 vaccine immunogenicity and the influence of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection require elucidation. Methods Stop the Spread Ottawa is a prospective cohort of individuals at-risk for or who have been infected with SARS-CoV-2, initially enrolled for 10 months beginning Octob...

BACKGROUND Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalised patients. Despite concern about possible harm associated with NS (e.g., hyperchloremic metabolic acidosis, impaired kidney function, and death), few large multi-centre randomised trials focused on critically ill patients have compared thes...

Background Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids given to hospitalized patients. Despite concern about possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function, and death), few large multicenter randomized trials focused on critically ill patients have compared these f...

Introduction: More than three years into the pandemic, there is persisting uncertainty as to the etiology, biomarkers, and risk factors of Post COVID-19 Condition (PCC). Serological research data remain a largely untapped resource. Few studies have investigated the potential relationships between post-acute serology and PCC, while accounting for cl...

INTRODUCTION: Predictors of COVID-19 vaccine immunogenicity and the influence of prior SARS-CoV-2 infection require elucidation. METHODS: Stop the Spread Ottawa is a prospective cohort of individuals at-risk for or who have been infected with SARS-CoV-2, initially enrolled for 10 months beginning October 2020. This analysis focuses on safety and im...

Introduction Equipoise, generally defined as uncertainty about the relative effects of the treatments being compared in a trial, is frequently referenced as an ethical standard for the conduct of randomized clinical trials. However, it seems to be defined in several different ways and may be used differently by different individuals. We explored ho...

The SARS-CoV-2 pandemic highlighted the need for rapid, collaborative, and population-centric research to define health impact, develop health care policies and establish reliable diagnostic and surveillance tests. Critical for these objectives were in-depth clinical data collected in standardized fashion and large numbers of various types of human...

Objectives Normal saline (NS) and Ringer’s lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important...

Purpose To investigate the robustness and longevity of SARS-CoV-2 immune responses conferred by natural infection and vaccination among priority populations such as immunocompromised individuals and people with post-acute sequelae of COVID-19 in a prospective cohort study (Stop the Spread Ottawa—SSO) in adults living in the Ottawa region. In this p...

Objectives We set out to identify and count the types of reasons that are used in contemporary scholarship about the ethical permissibility of randomized trials, with the goal of developing a finer-grained taxonomy of reasons than is currently employed by most participants in this literature. Because of its central role in justifying normative conc...

Indigenous children and young peoples live with an inequitable burden of acute rheumatic fever and rheumatic heart disease. In this Review, we focus on the epidemiological burden and lived experience of these conditions for Indigenous young peoples in Australia, New Zealand, and Canada. We outline the direct and indirect drivers of rheumatic heart...

Introduction Randomised controlled trials (RCTs) are widely viewed to generate the most reliable medical knowledge. However, RCTs are not always scientifically necessary and therefore not always ethical. Unfortunately, it is not clear when an RCT is not necessary or how this should be established. This study seeks to systematically catalogue justif...

Introduction 0.9% saline and Ringer’s lactate are the two most common resuscitation crystalloid fluids. 0.9% saline may lead to hyperchloraemic metabolic acidosis and may be associated with impaired kidney function and death. Few large multicentre randomised trials have been conducted to evaluate the effect of these two fluids on clinically importa...

Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic...

The purpose of this message is to introduce the CCTCC REB Accreditation WG's Final Recommendations (FRs), and the joint response by the CCTCC and Health Canada (HC) to the FRs. The WG was established in collaboration with HC, and reported to both organizations.

BACKGROUND: Recent reports have described a high incidence of acute rheumatic fever in northwestern Ontario. However, the full burden of Group A streptococcal infection and its complications, including acute post-streptococcal glomerulonephritis (APSGN), in the region is not well understood. OBJECTIVE: To document the pediatric and adult incidence...

Northwestern Ontario in Canada provides a unique clinical challenge for providing optimal medical care. It is a large geographic area (385,000 km(2)) and is home to 32 remote First Nations communities, most without road access. These communities suffer a heavy burden of infectious disease and specialist consultations are difficult to obtain. The Di...

Objective: To document a case series of 8 young First Nations patients diagnosed with acute rheumatic fever (ARF), a preventable disease that resulted in the death of 2 patients, in northwestern Ontario in the context of late diagnosis, overcrowded housing, and inadequate public health response. Design: Retrospective case series over an 18-month pe...

In a CMAJ practice article, Bagnall and colleagues describe acute rheumatic fever in a member of Canada’s immigrant population.1 The same article correctly identifies Canada’s First Nations as a population at risk for this disease. Social determinants of health are contributory: poverty, inadequate housing and systemic neglect. The Sioux Lookout Ac...

Abstract Background: To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods: We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria....

Urban centres often perform audits of vancomycin use as they face outbreaks of resistant organisms. We undertook this study to understand the indications and duration of intravenous vancomycin in a rural setting. We conducted a retrospective chart audit for all patients who received intravenous vancomycin over a 3-year period at a rural hospital in...

Background: The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling...

Introduction: Northwestern Ontario has a documented high rate of skin and soft-tissue infections due to community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). Recently, invasive illness from this common pathogen has become a serious clinical problem in the region. We sought to better understand this trend of invasive CA-MRSA....

Introduction: The quality of ethics review is often a bone of contention with trialists. Accreditation typically focuses on administrative requirements rather than assessing the quality of decisions. To date there are no established metrics of quality for research ethics review. Aim: As a first stage we reviewed the empirical research regarding eth...

Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs inter...

To determine the outcomes of patients discharged from the emergency department (ED) with a bloodstream infection (BSI) and how these outcomes are influenced by antibiotic treatment. We identified every BSI in adult patients discharged from our ED to the community between July 1, 2002, and March 31, 2011. The medical records of all cases were review...

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluste...

Background: Informed consent procedures in cluster randomized trials (CRTs) are considerably more complicated than in individually randomized trials. In a CRT, the units of randomization, intervention, and observation may differ in a single trial; there can be multiple levels of participants (individual and cluster level); consent may be required...

Purpose: We have shown that informed consent documents (ICDs) for clinical trials do not function well as decision aids i.e. tools to help decision makers through a systematic and deliberative decision making process. Here we examine what information (identified from regulatory documents such as Health Canada’s Good Clinical Practice, the Tri-Cou...

Purpose: Informed consent for research has traditionally emphasized information provision over support to people making a difficult decision. We have argued that applying the shared decision making model to informed consent decisions would benefit both trial participants and trialists. Here we describe initial efforts to develop a decision aid fo...

The prevalence of carbapenemase-producing Enterobacteriaceae (CPE) has increased during the past 10 years. Its detection is frequently difficult, because they do not always show a minimum inhibitory concentration (MIC) value for carbapenems in the resistance range. Both broth microdilution and agar dilution methods are more sensitive than disk diff...

The incidence of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) is traditionally high in remote areas of Canada with large Aboriginal populations. Northwestern Ontario is home to 28,000 First Nations people in more than 30 remote communities; rates of CA-MRSA are unknown. To determine the CA-MRSA rates and antibiotic sus...

Background: Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research e...

Rationale: Limited cross-sectional data exist to characterize the challenges of enrolling critically ill patients into research studies. Objectives: We aimed to describe recruitment practices, document factors that impact recruitment, and identify factors that may enhance future research feasibility. Methods: We conducted a prospective, observ...

Objective: The objective of this study was to determine whether skin and soft tissue infections (SSTIs) caused by methicillin-resistant Staphylococcus aureus (MRSA) in patients presenting to The Ottawa Hospital emergency departments (TOHEDs) differed from SSTIs caused by methicillin-susceptible Staphylococcus aureus (MSSA) with regard to risk fact...

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the...

In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes...

Purpose: Current informed consent processes tend to emphasize information provision rather than careful deliberation and decision-making. The International Patient Decision Aids Standards (IPDAS) provide recommendations for working systematically through difficult decisions, such that decision makers will understand outcome probabilities, explicitl...

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, f...

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the r...

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the question...

To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether...

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sp...

This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed...

The Keystone study of prevention of catheter-related infections in intensive care units raised important issues regarding infection control and research ethics. Infection control is an area common to public health and quality improvement. The performance of surveillance, the reporting of infection control data, and the response to complaints are al...

Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while out...

To the EditorResnick [1] has provided a very useful and succinctsummary of some of the important ethical and legal reasonswhy informed consent documents (ICDs) cannot simply bereplaced by conversations with study personnel as the chiefvehicle for obtaining informed consent from research parti-cipants. We agree that in debate surrounding the short-c...

Whipple's disease is a multisystem disease that can affect the heart with predominantly endocardial and pericardial involvement and, less often, myocardial inflammation. Previously diagnosed at autopsy, cardiac involvement in Whipple's disease is being recognized clinically more often. A 58-year-old man with Whipple's-related constrictive pericardi...

Bacteria grow as biofilms within CF airways. However, antibiotic susceptibility testing is routinely performed on planktonically-growing bacteria. This study assessed whether CF patients infected with multiresistant organisms had improved clinical outcomes if given antibiotics that inhibited their biofilm-grown bacteria. 110 patients with pulmonary...

There is no generally held definition of Staphylococcus aureus bacteraemia (SAB) of unknown source. For this paper, we consider it to occur when one or more positive blood cultures obtained from a patient grows S. aureus and the origin of the bacteraemia is uncertain after history, physical examination, chest radiography and any further investigati...

Evidence shows that the standard process for obtaining informed consent in clinical trials can be inadequate, with study participants frequently not understanding even basic information fundamental to giving informed consent. Patient decision aids are effective decision support tools originally designed to help patients make difficult treatment or...

We describe issues and outcomes in the development of a specialized, central institutional review board (IRB) for multicenter oncology protocols. Numerous authoritative bodies have called for a change to the ethics review system to better manage multicenter trials in terms of quality, timeliness, and efficiency. In 2003, the American Society of Cli...

To explore whether a home-based intermediate care program in a large Canadian city lowers the cost of care and to look at whether such home-based programs could be a solution to the increasing demands on Canadian hospitals. Single-arm study with historical controls. Department of Family Medicine at the Ottawa Hospital (Civic campus) in Ontario. Pat...

Background: Outpatient parenteral antimicrobial therapy (OPAT) allows patients who require IV antimicrobials but whose condition is otherwise stable to receive therapy in the home. Objective: To describe the current practices and clinical outcomes of adult patients who received parenteral antimicrobial therapy after discharge from The Ottawa Hospit...

Hospital in the home programs have been implemented in several countries and have been shown to be safe substitutions (alternatives) to in-patient hospitalization. These programs may offer a solution to the increasing demands made on tertiary care facilities and to surge capacity. We investigated the acceptance of this type of care provision with n...

To determine the effectiveness of a short-term intervention to promote best practices for control of respiratory infections in primary care physicians' offices. Before-after observational study. Family physicians' offices in Ottawa, Ont. General practitioners and office staff. Four infection-control practices (use of masks, alcohol-based hand gel,...

Standardized susceptibility testing fails to predict in vivo resistance of device-related infections to antimicrobials. We assessed agents and combinations of antimicrobials against clinical isolates of Staphylococcus epidermidis and S. aureus (methicillin-resistant S. aureus and methicillin-sensitive S. aureus) retrieved from device-associated inf...

The present authors hypothesised that bronchoscopy with protected specimen brush may sample biofilm-forming bacteria adherent to the airway wall, whereas traditional sputum collection may not. Pseudomonas aeruginosa obtained from sputum, bronchoalveolar lavage and protected brush, taken from the right upper lung bronchus of 12 adult patients with c...

We hypothesized that in adults with cystic fibrosis, the acquisition of a new strain of Pseudomonas aeruginosa may be associated with a pulmonary exacerbation. Eighty-four patients who were chronically infected with P. aeruginosa were prospectively followed from eight centers over a 26-month period. Patients had sputum cultures performed every 3 mo...

Infections of artificial devices typically follow a chronic, progressive, relapsing-remitting course with partial response to antibiotic therapy. These infections are characterized by biofilms, which result in resistance to host immunity, chronic inflammation and refractoriness to antibiotics. Antibiotic prophylaxis in surgery, based on a different...

Evidence suggests that Pseudomonas aeruginosa bacteria form biofilms within the airways of adults with cystic fibrosis (CF). The objective of this study was to determine whether clinical isolates of P. aeruginosa recovered from adults with CF have similar susceptibilities to individual antibiotics and to antibiotic combinations when grown as adhere...

A prospective, population-based, surveillance study of invasive soft-tissue infections due to group A streptococci was conducted in Ontario, Canada, from 1992 through 1996. Demographic and clinical information was obtained by patient interview and chart review. Isolates were characterized by M protein and T agglutination typing. The incidence of ne...

The treatment of respiratory tract infections (RTIs) continues to challenge the knowledgeable and conscientious physician. Upper RTIs such as sinusitis and tonsillitis/pharyngitis - while not generally life-threatening - are associated with personal cost and suffering, while infections of the lower respiratory tract, including community-acquired pn...

The present study tested acute and convalescent serum samples from 788 patients hospitalized for community-acquired pneumonia in seven Canadian provinces for antibodies to Coxiella burnetii. One hundred nine patients (13.8%) had antibodies to this microorganism, and seven patients had acute Q fever. Serological evidence of infection with C burnetii...

To describe an outbreak of hepatitis C in a clinical research study. Observational study. Tertiary-care hospital. Healthcare workers who volunteered to be subjects in a study of the metabolic effects of inhaled and oral corticosteroids who were unwittingly exposed to hepatitis C virus (HCV). Epidemiological investigation and serological analyses. O...

Cephalosporins, especially cefazolin, are widely used in the prevention of postoperative wound infections after cardiac operations. As more and more Staphylococcus aureus and Staphylococcus epidermidis strains are becoming resistant to cephalosporins and other antibiotics, alternative agents, such as glycopeptides, are often used as prophylaxis. We...

Objective: Cephalosporins, especially cefazolin, are widely used in the prevention of postoperative wound infections after cardiac operations. As more and more Staphylococcus aureus and Staphylococcus epidermidis strains are becoming resistant to cephalosporins and other antibiotics, alternative agents, such as glycopeptides, are often used as prop...

OBJECTIVE: To study the antimicrobial management of cancer patients with chemotherapy-induced neutropenia by Canadian physicians. SETTING: A cohort of 274 cancer patients with severe neutropenia (ie, less than 0.5x109 neutrophils/L) who participated in a prospective double-blind, placebo controlled study on antifungal prophylaxis conducted in 14 Ca...

In a prospective, multicentre double-blind trial, 151 patients over the age of 65 years were randomly assigned to receive either cefepime 2 g every 12 h for a minimum of 3 days and up to 14 days or ceftriaxone 1 g every 12 h for a minimum of 3 days and up to 14 days. Antibiotics were maintained until 48 h after fever had resolved; no other antibiot...

Aortitis usually produces aortic insufficiency by aortic root dilation. In rare cases the inflammation may involve the aortic valve cusps, causing valvular insufficiency. A patient in whom aortitis produced valvular masses, with aortic and peripheral arterial aneurysms, embolic episodes and aortic insufficiency is described. Valve replacement for s...

Necrotizing fasciitis, which is a severe and uncommon infection involving the subcutaneous tissues, is usually caused by group A streptococci. To our knowledge, however, group B streptococci (Streptococcus agalactiae) have been reported to cause necrotizing fasciitis in only 4 instances (2 involving neonates) over the past 4 decades. We report 3 ca...

To compare the efficacy of intravenous and oral ciprofloxacin and intravenous ceftazidime in the treatment of nosocomial pneumonia. Randomized, nonblinded, multicentre comparative trial. Seven Canadian university hospitals. Adult patients with moderate to severe pneumonia developing 72 h or longer after hospitalization. After informed consent was o...

To describe the diagnosis and management of bacterial pericarditis after heart transplantation. Two patients with Staphylococcus aureus pericarditis after heart transplantation were successfully treated conservatively with closed catheter drainage and antibiotics. The patients were alive three and six years, respectively, following surgery. At foll...

A 40-year-old man with no history of neuropsychiatric illness was taking one 250-mg tablet of mefloquine (MFQ) weekly for malaria prophylaxis while in Tanzania. He experienced no adverse reaction in association with his first two doses. Concurrently with both his third and his fourth dose he consumed about half a litre of whisky. On both occasions...