A5055360677- Ethics in Clinical Research
- Health Systems, Economic Evaluations, Quality of Life
- Healthcare cost, quality, practices
- Meta-analysis and systematic reviews
- Ethics in medical practice
- Dialysis and Renal Disease Management
- Biomedical Ethics and Regulation
- Palliative Care and End-of-Life Issues
- Patient-Provider Communication in Healthcare
- Central Venous Catheters and Hemodialysis
- Healthcare Policy and Management
- Statistical Methods in Clinical Trials
- Geriatric Care and Nursing Homes
- Pharmaceutical Practices and Patient Outcomes
- Mental Health and Patient Involvement
- Delphi Technique in Research
- Artificial Intelligence in Healthcare and Education
- Organ Donation and Transplantation
- Advanced Causal Inference Techniques
- Pharmacological Effects and Toxicity Studies
- Patient Satisfaction in Healthcare
- Hospital Admissions and Outcomes
- Emergency and Acute Care Studies
- Intensive Care Unit Cognitive Disorders
Ottawa Hospital Research Institute
2023-2025
Ottawa Hospital
2023-2025
University of Ottawa
2023-2025
Scientific Methods (United States)
2024
Western University
2017-2021
Institute of Philosophy
2019
This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation clusters to different sequences that dictate order (or timing) at which each will switch intervention condition. statement was developed allow unique characteristics this increasingly used study design. guideline using a Delphi survey and consensus meeting; is informed by CONSORT statements individual trials. items...
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 LMICs by examining types clusters, settings, author affiliations primary clinical focus evaluate adherence trial registration reporting requirements over time.
Purpose of the Conference: Hemodialysis is a life-sustaining treatment for patients with end-stage kidney disease. However, on dialysis continue to face poor quality life and short expectancies. Despite this, nephrology community conducts fewest randomized controlled trials any medical discipline, relying instead expert opinion guide many aspects hemodialysis care. There need conduct high-quality pragmatic in drive evidence-based practice. To this end, Innovative Clinical Trials Centers...
There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection their actual usual practice. Pragmatic randomized controlled (RCTs) are designed with intent addressing this discrepancy. While pragmatic RCTs increase relevance research findings to practice they also raise new ethical concerns (even while reducing others). To explore question, we interviewed key stakeholders aim identifying potential challenges design and conduct...
Objectives To describe reporting of informed consent in pragmatic trials, justifications for waivers and alternative approaches to standard written consent. identify factors associated with (1) not (2) obtaining Methods Survey primary trial reports, published 2014–2019, identified using an electronic search filter trials implemented MEDLINE, registered ClinicalTrials.gov. Results Among 1988 132 (6.6%) did include a statement about participant consent, 1691 (85.0%) reported had been obtained,...
Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published 2012, provides 15 recommendations address issues arising within 7 domains: justifying CRT design, research ethics committee review, identifying participants, obtaining informed consent,...
For society to benefit from new clinical knowledge the expectation should be participate in research, writes <b>Marion K Campbell</b>; <b>Charles Weijer and colleagues</b> agree but argue that fundamental need for consent makes this an imperfect duty
There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availability of electronic records, centralized research ethics review, novel trial designs, combined with support resources from governments worldwide patient-centered research, have created an unprecedented opportunity advance the conduct trials, which can ultimately improve patient outcomes....
The SUPPORT trial highlights ethical challenges raised by comparative effectiveness randomized controlled trials (ceRCTs) involving one or more usual care interventions. Debate about the has focused on whether study interventions posed "reasonably foreseeable risks" to enrolled infants and, thereby, reflects a preoccupation with U.S. regulations. As ceRCTs are conducted globally, our analysis of is grounded in internationally accepted principles. We argue that central issue following: should...
Hemodialysis is a life-sustaining treatment for persons with kidney failure. However, those on hemodialysis still face poor quality of life and short expectancy. High-quality research evidence from large randomized controlled trials needed to identify interventions that improve the experiences, outcomes, health care receiving hemodialysis. With support Canadian Institutes Health Research its Strategy Patient-Oriented Research, Innovative Clinical Trials in Centers initiative brought together...
Background: Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is lack empirical research addresses ethical issues generated pragmatic CRTs hemodialysis. Objective: To identify stakeholder perceptions conducted Design: Qualitative study semi-structured interviews. Setting: In-person or telephone interviews with...
Randomized controlled trial (RCT) designs exist on an explanatory-pragmatic spectrum, depending the degree to which a study aims address question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, explanatory approach design emphasizes hypothesis testing about mechanisms action treatments under ideal conditions (efficacy), whereas pragmatic effectiveness two more available real-world conditions. Interest in, number of, trials has grown substantially recent...
The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. Ottawa Statement on the Ethical Design and Conduct Cluster Randomised Trials is first international guidance document specific to trials, but it unknown if adequately addresses issues settings. In this paper, we seek identify any gaps relevant conducted Our method (1) analyse a prototypical trial setting (PURE Malawi trial) with Statement; (2) design or conduct not captured (3) make...
Background: All studies classified as research involving human participants require ethics review. Most regulation and guidance on ethical oversight of was written for pharmacotherapy interventions. Interpretation such cluster-randomized trials stepped-wedge trials, which commonly evaluate complex non-therapeutic interventions knowledge translation, public health, or health service delivery interventions, can pose challenges to researchers regulators. Current guidance: The Ottawa Statement...
Background: Cluster randomized trials (CRTs) are in which intact groups such as hemodialysis centers or shifts to treatment control arms. Pragmatic CRTs have been promoted a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, intervention and data collection vary CRT, challenging identification of participants. Moreover, when waiver patient consent is granted by ethics committee, there an open question whether...