Welcome from a Principal Investigator (NIH Pragmatic Trials Collaboratory): 2-min video. 

• Summary: Dr. Kevin Weinfurt (Principal Investigator - NIH Pragmatic Trials Collaboratory) welcomes learners to the program.

NIH Pragmatic Trials Collaboratory - Is a Pragmatic Clinical Trial Right for Your Research Question?: 2-min webinar.

• Summary: Dr. Wendy Weber emphasizes that the hypothesis and research question should be thoroughly considered before deciding to do a pragmatic trial, as pragmatic trials are not the appropriate design for all questions. A breakdown of the settings, participants, interventions, and outcomes relevant to explanatory (questions around efficacy under ideal conditions) vs. pragmatic trials (questions around effectiveness in real-world settings) is also provided. 

Riva JJ, et al. What is your research question? An introduction to the PICOT format for clinicians. J Can Chiropr Assoc. 2012 Sep;56(3):167-71. (5-page paper)

• Summary: Overviews the PICOT approach that frames a research question by specifying the target population (P), the intervention (I) of interest, the comparator (C) intervention, key outcomes (O), and the time frame (T) over which the outcomes are assessed.

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 4 - Developing and  Refining the Research Questions (Chapter: Design - Using Electronic Health Record Data in Pragmatic Clinical Trials): 1-page website.

• Summary: Acknowledging that the research question should drive the data requirements, this page highlights that researchers (in collaboration with various partners) should consider - at an early stage - what data are needed to answer the research question. In turn, the availability of data may lead to researchers refining their question before embarking too far into the study. * Note that while not all pragmatic trials leverage routinely collected health data (including but not limited to electronic health records [EHR]), it is common for various forms of routinely collected data to be used in the Canadian context.

NIH Pragmatic Trials Collaboratory (Living Textbook): Section 4 - Partner Engagement Throughout the Pragmatic Clinical Trial Life Cycle (Chapter: Building Partnerships and Teams to Ensure a Successful Trial): 1-page website.

• Summary: Highlights three broad stages for partnerships: 1. Planning the study (e.g., choosing the research question, designing the intervention, selecting outcome[s], determining inclusion/exclusion criteria, designing study protocol to minimize burden for patients and clinicians, promoting the study, drafting/reviewing study materials); 2. Conducting the study (e.g., developing recruitment strategies, promoting and assessing compliance study requirements, serving as champions, supporting participant retention, advising on analyses, interpreting study results); 3. Disseminating the results (e.g., determining key messages, identifying dissemination strategies, assisting with conference abstracts and manuscripts, sharing findings via networks, supporting implementation and sustainability of the intervention, promoting changes to policies and/or guidelines).

Elizabeth A. Suarez, Soko Setoguchi. Chapter 6 - What is the research question? Pragmatic Randomized Clinical Trials, Academic Press, 2021, Pages 71-83. (13-page textbook chapter) * As this is an optional resource, an institutional login (e.g., university or research institute e-mail address) is required to access this material. 

• Summary: Highlights that a research question will clearly define the hypothesis, the research rationale, and core elements of the study: the population (P), the intervention (I), the comparator (C), the outcome (O), the timing or duration of study (T), the setting, and the effect to be estimated. Emphasizes the importance of starting with a well-defined research question and illustrates how each element of a research question translates into the design of a pragmatic clinical trial.

Tambor E, et al. One size does not fit all: Insights for engaging front-line clinicians in pragmatic clinical trials. Learn Health Syst. 2020 Oct 13;5(4):e10248. (8-page paper)

• Summary: Physicians, nurses, and other care providers from healthcare delivery organizations stressed the importance of engaging clinicians early in the pragmatic trial planning process. i.e., Early involvement helps identify clinically relevant research questions, provide input on study design, and customize protocols to fit unique clinic workflows.