NIH Collaboratory researchers in 2020 reported study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

• Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: race as an example. Contemp Clin Trials. 2020;88:105775.
• Ethics and collateral findings in pragmatic clinical trials. Am J Bioeth. 2020;20(1):6-18. (See also: Response to open peer commentaries on “Ethics and collateral findings in pragmatic clinical trials.” Am J Bioeth. 2020;20(1):W9-W11.)
• Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable. J Am Med Inform Assoc. 2020;27(4):634-638.
• Evidence from pragmatic trials during routine care – slouching toward a learning health system. N Engl J Med. 2020;382(16):1488-1491.
• Certificates of confidentiality and unexpected complications for pragmatic clinical trials. Learn Health Sys. 2020;e10238.
• Patients’ views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study. J Gen Intern Med. 2020;35(12):3436-3442.
• Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials. Stat Med. 2020;39(28):4218-4237.
• Stakeholder perspectives regarding pragmatic clinical trial collateral findings. Learn Health Syst. 2020;e10245.
• Applying patient-reported outcome methodology to capture patient-reported health data: report from an NIH Collaboratory roundtable. Healthc (Amst). 2020;8(3):100442.

NIH Collaboratory Distributed Research Network

• Considerations for using distributed research networks to conduct aspects of randomized trials. Contemp Clin Trials Commun. 2020;17:100515.
• Diagnosed prevalence of Alzheimer’s disease and related dementias in Medicare Advantage plans. Alzheimers Dement (Amst). 2020;12(1):e12048.

ACP PEACE NIH Collaboratory Trial

• Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE): the study protocol for a pragmatic stepped-wedge trial of older patients with cancer. BMJ Open. 2020;10(7):e040999.

EMBED NIH Collaboratory Trial

• Design and analysis considerations for cohort stepped wedge cluster randomized trials with a decay correlation structure. Stat Med. 2020;39(4):438-455.
• Progress report on EMBED: a Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder. J Psychiatr Brain Sci. 2020;5:e200003.
• Commentary: Right truncation in cluster randomized trials can attenuate the power of a marginal analysis. Int J Epidemiol. 2020;49(3):964-967.
• Interrupted time series of user-centered clinical decision support implementation for emergency department-initiated buprenorphine for opioid use disorder. Acad Emerg Med. 2020;27(8):753-763.
• Association of perceived electronic health record usability with patient interactions and work-life integration among US physicians. JAMA Netw Open. 2020;3(6):e207374.
• Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview. Stat Methods Med Res. 2020 Jul 6:962280220932962. Epub ahead of print.
• Trends in emergency department visits and hospital admissions in health care systems in 5 states in the first months of the COVID-19 pandemic in the US. JAMA Intern Med. 2020;180(10):1328-1333.

HiLo NIH Collaboratory Trial

• Regulation and effects of FGF23 in chronic kidney disease. Annu Rev Physiol. 2020;82:365-390.

LIRE NIH Collaboratory Trial

• The effect of including benchmark prevalence data of common imaging findings in spine image reports on health care utilization among adults undergoing spine imaging: a stepped-wedge randomized clinical trial. JAMA Netw Open. 2020;3(9):e2015713

PPACT NIH Collaboratory Trial

• Satisfaction with primary care providers and health care services among patients with chronic pain: a mixed-methods study. J Gen Intern Med. 2020;35(1):190-197.
• Interactive group-based orientation sessions: a method to improve adherence and retention in pragmatic clinical trials. Contemp Clin Trials Commun. 2020;17:100527.

PRIM-ER NIH Collaboratory Trial

• Design and implementation of a clinical decision support tool for Primary Palliative Care for Emergency Medicine (PRIM-ER). BMC Med Inform Decis Mak. 2020;20(1):13.
• Access to home and community health services for older adults with serious, life-limiting illness: a study protocol. Am J Hosp Palliat Care. 2021;38(1):12-18.
• Primary Palliative Care for Emergency Medicine (PRIM-ER): applying form and function to a theory-based complex intervention. Contemp Clin Trials Commun. 2020;18:100570.
• Effectiveness and reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) pilot study: a qualitative analysis. J Gen Intern Med. 2020 Oct 27. Epub ahead of print.

PROVEN NIH Collaboratory Trial

• Hospital transfer rates among US nursing home residents with advanced illness before and after initiatives to reduce hospitalizations. JAMA Intern Med. 2019;180(3):385-394.
• Advance care planning video intervention among long-stay nursing home residents: a pragmatic cluster randomized clinical trial. JAMA Intern Med. 2020;180(8):1070-1078.
• Impact of an advance care planning video intervention on care of short-stay nursing home patients. J Am Geriatr Soc. 2020 Nov 7. Epub ahead of print.

SPOT NIH Collaboratory Trial

• Using predictive analytics to improve pragmatic trial design. Clin Trials. 2020;17(4):394-401.

STOP CRC NIH Collaboratory Trial

• Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial. Trials. 2020;21(1):91.
• Prospective cohort study of predictors of follow-up diagnostic colonoscopy from a pragmatic trial of FIT screening. Sci Rep. 2020;10(1):2441.

TSOS NIH Collaboratory Trial

• Experiences and insights from the early US COVID-19 epicenter: a Rapid Assessment Procedure Informed Clinical Ethnography case series. Psychiatry. 2020;83(2):115-127.
• A pragmatic approach to psychometric comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in acutely injured trauma patients. Psychiatry. 2020:1-12. Epub ahead of print.
• Ethical and regulatory concerns in pragmatic clinical trial monitoring and oversight. Ethics Hum Res. 2020;42(5):29-37.
• Rapid ethnographic assessment of the COVID-19 pandemic April 2020 ‘surge’ and its impact on service delivery in an acute care medical emergency department and trauma center. BMJ Open. 2020;10(10):e041772.