Welcome from the Executive Director (Ontario SPOR SUPPORT Unit): 3-min video. 

• Summary: Dr. Vasanthi Srinivasan (Ontario SPOR SUPPORT Unit) welcomes learners to the program.

NIH Pragmatic Trials Collaboratory - Engaging With Stakeholders in Pragmatic Clinical Trials (January 31, 2020): 10-minute webinar (9-slide presentation, slides 15-23).

• Summary: Dr. Gregory Simon discusses the value of partner engagement (e.g., with health system leaders, clinicians, operational leads, patients, caregivers, advocacy groups, policymakers, regulators, funders, researchers, product manufacturers) at all stages of a trial. Describes two types of partners: the wider community of partners (needed to define the research question and design of the intervention) and local partners (that are essential to trial implementation at specific sites). Poses questions for a researcher to ask themselves: i.e., Who will use the evidence from the study to make decisions? Who will be affected by those decisions? Who can help minimize potential barriers to study completion? Encourages patience when building partnerships, to assess capacity of health system partners in the pilot stage, to engage partners across all stages of the study, and to expect turnover. Concludes by stating that researchers should articulate reasons to invest in the intervention under study (e.g., alignment with organizational priorities), describe the impacts on clinical workflows during the trial, and outline sustainability plans. 

Johnson KE, et al. A guide to research partnerships for pragmatic clinical trials. BMJ. 2014 Dec 1;349:g6826. (7-page paper)

• Summary: Describes best practices for researchers and partners in health systems as they establish relationships, develop research questions, and implement sustainable pragmatic trials. Emphasizes that a successful pragmatic trial starts with strong partnerships between researchers and health systems, goes through a rigorous objective evaluation of the partner health system’s ability to participate, and ends with evidence about sustainable ways to improve care.

NIH Pragmatic Trials Collaboratory - Building a Study Team for a Pragmatic Clinical Trial (January 31, 2020): 6-minute webinar (4-slide presentation, slides 24-27).

• Summary: Dr. Lesley Curtis emphasizes that pragmatic trials are a “team sport” and that various partners should be involved in the planning stage and throughout the entire trial. Overviews the size of the team designing the study vs. the team delivering the intervention and highlights potential team members (e.g., researchers, clinical staff, healthcare system leaders, biostatisticians, professional society leaders, information technology specialists, research assistants, communications specialists, patients and advocates, project coordinators).

Strategy for Patient-Oriented Research (SPOR) Evidence Alliance - Patient and Public Partner Engagement in Research (2023). (2-page document).

• Summary: Two-pager answering the following questions: Who are patients? Who are the public? What is patient and public engagement in health research? How will I (as a patient or member of the public) be engaged? What will I do? Highlights patient and public partner roles during the planning stage (e.g., during protocol development) and the reporting stage (e.g., during manuscript writing and publication). *Note that modules focused entirely on patients and the public as partners in pragmatic trials will be featured in the near future. 

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 3 - Deciding Who to Engage (Chapter: Building Partnerships and Teams to Ensure a Successful Trial): 1-page website.

• Summary: Poses two questions for consideration: 1) Who can help minimize potential barriers to study completion? and 2) Who will use the evidence from the study to make decisions or be affected by those decisions? Overviews various types of partners (e.g., patients, caregivers, advocacy groups, clinicians, healthcare delivery organization leaders, operational personnel, policy makers and regulators, research funders, product manufacturers, medical societies).