National Institutes of Health - Introduction to the Principles and Practice of Clinical Research (Choosing a Research Question: Introduction to Choosing a Research Topic Part 1 of 3, February 6, 2022): 14-min webinar.

• Summary: Dr. John Powers overviews the activity of choosing and refining a research question. It is emphasized that, even when research proposals/protocols are put forward for review, it is often the case that the protocols do not clearly state the research question under study. Advice is provided for selecting a topic/idea, and for refining that idea into a feasible, interesting, novel, ethical, and relevant research question. The webinar concludes by stressing the importance of an experienced mentor in helping researchers navigate this critical step.

Fandino W. Formulating a good research question: Pearls and pitfalls. Indian J Anaesth. 2019 Aug;63(8):611-616. (6-page paper)

• Summary: Refining a good research question can be a time-consuming and challenging task. This paper explores recommendations to consider before starting any research project (including a pragmatic clinical trial), and outlines the main difficulties faced when it comes time to turn an exciting idea into a well-defined and feasible research question.

Alberta SPOR Support Unit (AbSPORU) - An Introduction to Pragmatic Clinical Trials (April 27, 2020): 20-min webinar.

• Summary: Dr. Robin Lau emphasizes how it all begins with the research question (illustrating the flow diagram where a researcher either chooses an observational vs. an experimental study - like a clinical trial), compares and contrasts explanatory and pragmatic clinical trials, provides guidance for identifying partners relevant to pragmatic trials (e.g., who to engage to help select a research topic/idea and refine it into a research question), and breaks down the nine domains of the PRECIS-2 Tool.

Lurie JD, Morgan TS. Pros and cons of pragmatic clinical trials. J Comp Eff Res. 2013 Jan;2(1):53-8. (6-page paper)

• Summary: Pragmatic trials should be designed with a conscious effort to generate evidence with a greater external validity by making the research question as similar as possible to the questions faced by clinical decision makers (i.e., patients and their families, physicians, policy makers and administrators). Clarity and transparency about the specifics of the research question are the keys to designing, as well as interpreting, any clinical trial. This paper helps to map one’s intention for the trial (i.e., to generate evidence that can be used to make a specific decision) to the various facets of a research question that one wishes to answer using a design that leans more pragmatic in nature.

NIH Pragmatic Trials Collaboratory - Why Should I Do A Pragmatic Trial?: 2-min webinar.

• Summary: Dr. Lesley Curtis briefly answers the question “Why should I do a pragmatic trial?” (vs. a clinical trial that has a more explanatory intention) and emphasizes that pragmatic trials are not always faster or less expensive than traditional clinical trials.

Maclure M. Explaining pragmatic trials to pragmatic policy-makers. CMAJ. 2009 May 12;180(10):1001-3. (3-page commentary)

• Summary: The purpose of this commentary is to help researchers use the PRECIS Tool to promote pragmatic trials with language comfortable to relevant parties and partners (e.g., clinicians, healthcare system leaders, policy makers). In summary, the author concludes: pragmatic trials can be characterized by numerous contrasts with explanatory trials, but the two types of trials should be defined in simple approximate terms (e.g., the trial’s intent or purpose). For policymakers, it is suggested that one states that pragmatic trials are real-world studies for making decisions, whereas explanatory trials are specialized studies for generating information.