NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the Demonstration Projects.
So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:
NIH Collaboratory Coordinating Center
- Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: a systematic review. PLoS ONE. 2019;14(8):e0219894.
- Pragmatic clinical trials offer unique opportunities for disseminating, implementing, and sustaining evidence-based practices into clinical care: proceedings of a workshop. Healthc (Amst). 2019;7(1):51-57.
- Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: race as an example. Contemp Clin Trials. 2019 Jun 19. [Epub ahead of print]
- Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States. Clin Trials. 2019 Jul 1. [Epub ahead of print]
- Addressing guideline and policy changes during pragmatic clinical trials. Clin Trials. 2019;16(4):431-437.
- The promise of pragmatic clinical trials embedded in learning health systems. EGEMS (Wash DC). 2019;7(1):10.
NIH Collaboratory Distributed Research Network
- Cancer screening results and follow-up using routinely collected electronic health data: estimates for breast, colon, and cervical cancer screenings. J Gen Intern Med. 2019;34(3):341-343.
- Antibiotic dispensing following pediatric visits in the US emergency departments and outpatient settings from 2006 to 2016. Pharmacol Res Perspect. 2019;7(5):e00512.
- Incidence of statin use in older adults with and without cardiovascular disease and diabetes mellitus, January 2008-March 2018. PLoS One. 2019;14(12):e0223515.
- Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data. Support Care Cancer. 2019 Sep 7. [Epub ahead of print]
ABATE Infection Demonstration Project
- Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet. 2019;393(10177):1205-1215.
EMBED Demonstration Project
- Computerized clinical decision support system for emergency department–initiated buprenorphine for opioid use disorder: user-centered design. JMIR Hum Factors. 2019;6(1):e13121.
- User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open. 2019;9(5):e028488.
- Identifying opioid use disorder in the emergency department: multisystem electronic health record–based computable phenotype derivation and validation study. JMIR Med Inform. 2019;7(4):e15794.
- A scalable, automated warm handoff from the emergency department to community sites offering continued medication for opioid use disorder: lessons learned from the EMBED trial stakeholders. J Subst Abuse Treat. 2019;102(7):47-52.
- An integrated web application for decision support and automation of EHR workflow: a case study of current challenges to standards-based messaging and scalability from the EMBED trial. JAMIA Open. 2019 Oct 14. [Epub ahead of print]
PPACT Demonstration Project
- Satisfaction with primary care providers and health care services among patients with chronic pain: a mixed-methods study. J Gen Intern Med. 2019 Oct 21. [Epub ahead of print]
- Development and assessment of a crosswalk between ICD-9-CM and ICD-10-CM to identify patients with common pain conditions. J Pain. 2019;20(12):1429-1445.
- Taking opioids in times of crisis: Institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S. Int J Drug Policy. 2019 Dec;74:62-68.
PRIM-ER Demonstration Project
- Primary Palliative Care for Emergency Medicine (PRIM-ER): protocol for a pragmatic, cluster-randomised, stepped wedge design to test the effectiveness of primary palliative care education, training and technical support for emergency medicine. BMJ Open. 2019;9(7):e030099.
PROVEN Demonstration Project
- Nursing home characteristics associated with implementation of an advance care planning video intervention. J Am Med Dir Assoc. 2019;20(7):804-809.e1.
- Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting. BMC Health Serv Res. 2019;19(1):527.
- Proxies viewing decision support video in nursing home report higher advance care planning engagement. J Am Med Dir Assoc. 2019 Oct 3. [Epub ahead of print]
- Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting: a mixed-methods examination. Trials. 2019;20(1):656.
- Black nursing home residents more likely to watch advance care planning video. J Am Geriatr Soc. 2019 Oct 29. [Epub ahead of print]
SPOT Demonstration Project
- Improving pragmatic clinical trial design using real-world data. Clin Trials. 2019;16(3):273-282.
- Principles and procedures for data and safety monitoring in pragmatic clinical trials. Trials. 2019;20(1):690.
STOP CRC Demonstration Project
- Challenges in assessing population reach in a pragmatic trial. Prev Med Rep. 2019;15:100910.
- A cost-effectiveness analysis of a colorectal cancer screening program in safety net clinics. Prev Med. 2019;120:119-125.
- Using a continuum of hybrid effectiveness-implementation studies to put research-tested colorectal screening interventions into practice. Implement Sci. 2019;14(1):53.
- Factors affecting adherence in a pragmatic trial of annual fecal immunochemical testing for colorectal cancer. J Gen Intern Med. 2019;34(6):978-985.
TiME Demonstration Project
- The TiME trial: a fully embedded, cluster-randomized, pragmatic trial of hemodialysis session duration. J Am Soc Nephrol. 2019;30(5):890-903.
- Ethical issues in pragmatic cluster-randomized trials in dialysis facilities. Am J Kidney Dis. 2019;74(5):659-666.