Developing Pragmatic Trial Protocols (Part 3 of 3)
(Week of January 13, 2025)
(Week of January 13, 2025)
Module 7-3: SPIRIT for Pragmatic Trial Protocols: Stats, Oversight, and Ethics (14-Minute Video)
In this final module of our SPIRIT-based series, we cover what reviewers, funders, and ethics boards look for in the statistical and oversight sections of your protocol. We walk through sample size justification for pragmatic and cluster trials, core statistical methods for primary and secondary outcomes, handling missing data, and planning prespecified subgroup and sensitivity analyses. We then cover trial oversight, including DSMBs, interim analyses and stopping guidelines, and risk-based monitoring. We close with key ethics sections: approvals, protocol amendments, consent including waivers or alterations, confidentiality, and post-trial considerations.
** The video's content and narration were generated with the assistance of artificial intelligence, with human guidance and oversight throughout the process. **
Abstract: The Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors’ housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program.
Summary: This document is an example of a completed SPIRIT 2013 checklist for a pragmatic cluster randomized trial of the Cardiovascular Health Awareness Program (CHAP) conducted among social housing residents in Ontario and Quebec. It cross-references each SPIRIT reporting requirement—covering trial design, participants, interventions, outcomes, randomization, data collection and analysis, ethics, monitoring, and dissemination—to the exact pages or supplementary files in the study protocol. The checklist demonstrates that the CHAP trial protocol meets SPIRIT standards for transparency and completeness, with explicit justification where items are not applicable due to the study’s minimal-risk, pragmatic design.
NIH Pragmatic Trials Collaboratory: Data and Resource Sharing
This resource provides examples of trial materials from Collaboratory-supported studies, including study protocols, consent and authorization documents, data dictionaries, analytic code and tools, and links to public use datasets.