In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.
The program contributed more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.
The total number of published articles from the program surpassed 340.
Coordinating Center
- Ensuring virtual vigilance in decentralized clinical trials
- Making pragmatic clinical trials more pragmatic
Cross-Core and Cross-Trial Collaborations
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change
- Factors affecting post-trial sustainment or de-implementation of study interventions: A narrative review
- Collection of patient-reported outcome measures in rural and underserved populations
Core Working Groups
Biostatistics and Study Design Core
- Designing individually randomized group treatment trials with repeated outcome measurements using generalized estimating equations
- Robust analysis of stepped wedge trials using composite likelihood models
- Evaluating analytic models for individually randomized group treatment trials with complex clustering in nested and crossed designs
- Planning stepped wedge cluster randomized trials to detect treatment effect heterogeneity
Electronic Health Records Core
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
Ethics and Regulatory Core
- Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change
- Recurring and emerging ethical issues in pragmatic clinical trials
- Ethical considerations for sharing aggregate results from pragmatic clinical trials
- Untapped potential? Representativeness in pragmatic clinical trials
Community Health Improvement Core
Implementation Science Core
- Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change
- Factors affecting post-trial sustainment or de-implementation of study interventions: A narrative review
- Similarities and differences between pragmatic trials and hybrid effectiveness-implementation trials
Patient-Centered Outcomes Core
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Collection of patient-reported outcome measures in rural and underserved populations
NIH Collaboratory Trials
ABATE Infection
BackInAction
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials
- Factors affecting post-trial sustainment or de-implementation of study interventions: A narrative review
BeatPain Utah
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study
- Collection of patient-reported outcome measures in rural and underserved populations
- Telehealth delivery of physical therapist-led interventions for persons with chronic low back pain in underserved communities: Lessons from pragmatic clinical trials
EMBED
- Trends in the prescribing of buprenorphine for opioid use disorder, 2019-2023
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
FM-TIPS
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Through the lens of movement-evoked pain: A theoretical framework of the "pain-movement interface" to guide research and clinical care for musculoskeletal pain conditions
- Collection of patient-reported outcome measures in rural and underserved populations
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
GGC4H
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Anxiety, depression, and suicidal ideation among early adolescents during the COVID-19 pandemic
- Pilot implementation of Guiando Buenas Decisiones, an evidence-based parenting program for Spanish-speaking families, in pediatric primary care in a large, U.S. health system: A qualitative interview study
GRACE
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Barriers and facilitators to integrating acupuncture into the U.S. health care system: A scoping review
- Collection of patient-reported outcome measures in rural and underserved populations
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
I CAN DO Surgical ACP
ICD-Pieces
LIRE
- Factors affecting post-trial sustainment or de-implementation of study interventions: A narrative review
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
NOHARM
- Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH Pragmatic Trials Collaboratory
- Collection of patient-reported outcome measures in rural and underserved populations
- Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials
Nudge
OPTIMUM
- Integrating a community advisory board into a pragmatic trial of mindfulness for chronic low back pain
- Collection of patient-reported outcome measures in rural and underserved populations
PRIM-ER
- Emergency nurses' perceived barriers and solutions to engaging patients with life-limiting illnesses in serious illness conversations: A United States multicenter mixed-method analysis
- Serious illness communication skills training for emergency physicians and advanced practice providers: a multi-method assessment of the reach and effectiveness of the intervention
PROVEN
SPOT
STOP CRC
TSOS
- Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors?
- Stepped collaborative care for pain and posttraumatic stress disorder after major trauma: a randomized controlled feasibility trial
- Can baseline patient clinical and demographic characteristics predict response to early posttraumatic stress disorder interventions after physical injury?
- Engaging and following physical injury survivors at risk for developing posttraumatic stress disorder symptoms: A 25 site US national study
- Factors affecting post-trial sustainment or de-implementation of study interventions: A narrative review