Tag Archives: TSOS

New Online Course from NIH: Pragmatic & Group-Randomized Trials

Biostatistics, Clinical trials, Cluster Randomized Trials, Data analysis, Pragmatic clinical trials, Stepped-wedge, , , , , , , ,

The National Institutes of Health’s Office of Disease Prevention (ODP) has just released a free, self-paced online course on designing and analyzing pragmatic and group-randomized trials. The course, which is presented by ODP Director Dr. David Murray, includes a series of seven video presentations plus slide sets, reference materials, and guided activities.

Course segments typically last 25 to 35 minutes. Presentations can be accessed individually and include the following topics:

Picture of course presenter Dr. David Murray
Course presenter Dr. David Murray, Director, Office of Disease Prevention, NIH (image courtesy NIH)

The course is designed for faculty, fellows, and graduate students who have had training in the basics of research design and regression analysis. Part 5 (“Examples”) of the presentation includes multiple examples drawn from NIH Collaboratory Demonstration Projects, including the Strategies and Opportunities to Stop Colorectal Cancer (STOP-CRC), Collaborative Care for Chronic Pain in Primary Care (PPACT), Trauma Survivors Outcomes and Support (TSOS), and Improving Chronic Disease Management with Pieces (ICD-PIECES) studies.

Trauma Survivors Outcomes and Support (TSOS) trial publishes design paper

Clinical trials, Cluster Randomized Trials, Comparative Effectiveness Research, Pragmatic clinical trials, Stepped-wedge, , , , ,

The study team for the Trauma Survivors Outcomes and Support (TSOS) trial recently published their study protocol in Implementation Science. TSOS, an NIH Health Care Systems Research Collaboratory Demonstration Project, is an effectiveness-implementation hybrid trial designed to test the delivery of screening and intervention for PTSD and comorbidities across 24 U.S. level I trauma center sites. The study employs a stepped-wedge, cluster-randomized design in which sites are randomized sequentially to initiate the intervention. The study aims to determine if injured patients receiving a collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared with control patients receiving usual care. The study will also evaluate whether intervention patients demonstrate significant reductions in depressive symptoms and associated suicidal ideation, alcohol use problems, and improvements in physical function.

The open access article is available here: An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity