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Reduction in movement-evoked pain and fatigue during initial 30-minute TENS treatment predicts TENS responders in women with fibromyalgia11/11/2020Publication from the FM TIPS Demonstration ProjectLeslie Crofford; Kathleen Sluka
Impact of an advance care planning video intervention on care of short-stay nursing home patients11/7/2020Publication from the PROVEN Demonstration ProjectLacey Loomer; Jessica Ogarek; Susan Mitchell; Angelo Volandes; Roee Gutman; Pedro Gozalo; Ellen McCreedy; Vincent Mor
Effectiveness and reach of the Primary Palliative Care for Emergency Medicine (PRIM-ER) Pilot Study: a qualitative analysis10/27/2020Publication from the PRIM-ER Demonstration ProjectFrank Chung; Sarah Turecamo; Allison Cuthel; Corita Grudzen
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 center10/20/2020Publication from the TSOS Demonstration ProjectLawrence Palinkas; Lauren Whiteside; Deepika Nehra; Allison Engstrom; Mark Taylor; Kathleen Moloney; Douglas Zatzick
ACP PEACE Study Redesign (Details)10/7/2020This document describes changes to the ACP PEACE stepped-wedge study design to address effects caused by the onset of COVID-19.Angelo Volandes; James Tulsky
Estimating the Number of Self-Harm Events Not Identified by Encounter Diagnoses in Health Records9/25/2020Preprint from the SPOT Demonstration ProjectGregory Simon; Susan Shortreed; Jennifer Boggs; Gregory Clarke; Rebecca Rossom; Julie Richards; Arne Beck
Disseminating trial results: we can have both faster and better9/24/2020Publication from the NIH Collaboratory Coordinating CenterGregory Simon; Rachel Richesson; Adrian Hernandez
Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight 9/16/2020Publication from the TSOS Demonstration Project and the Ethics and Regulatory CoreDouglas Zatzick; Michelle Roberts; Dylan Fisher; Lea Parker; Doyanne Darnell; Jeremy Sugarman; Judith Carrithers; Kevin Weinfurt; Gregory Jurkovich
LIRE Main Outcome Paper9/4/2020LIRE Main Outcome PaperJeffrey Jarvik; Eric Meier; Kathryn James; Laura Gold; Katherine Tan; Larry Kessler; Pradeep Suri; David Kallmes; Daniel Cherkin; Richard Deyo; Karen Sherman; Safwan Halabi; Bryan Comstock; Patrick Luetmer; Andrew Avins; Sean Rundell; Brent Griffith; Janna Friedly; Danielle Lavallee; Kari Stephens; Judith Turner; Brian Bresnahan; Patrick Heagerty
MOTIFS Publication: Stakeholder perspectives regarding pragmatic clinical trial collateral findings8/28/2020Publication from the MOTIFS supplementStephanie Morain; Stephanie Startz; Debra Mathews; Kevin Weinfurt; Elizabeth May; Juli Bollinger; Gail Geller; Jeremy Sugarman
Diversity Supplement Publication: Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials8/21/2020Publication from the Diversity supplementMonique Anderson; Adrian Hernandez; Robert Mentz; Siyun Yang; Kingshuk Choudhury
MOTIFS Publication: Patients' views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study8/19/2020Publication from the MOTIFS supplementJuli Bollinger; Kevin Weinfurt; Jeremy Sugarman; Gail Geller; Elizabeth May; Stephanie Morain; Debra Mathews
A pragmatic approach to psychometric comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in acutely injured trauma patients8/6/2020Publication from the TSOS Demonstration ProjectDouglas Zatzick; Rddhi Moodliar; Joan Russo; Michele Bedard-Gilligan; Kathleen Moloney; Peyton Johnson; Sara Seo; Natalie Viziri
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 US8/3/2020Publication from the EMBED Demonstration ProjectEdward Melnick; Gail D'Onofrio; Molly Jeffery; Hyung Paek; Timothy Platts-Mills; William Soares; Jason Hoppe; Nicholas Genes; Bidisha Nath
ADAPTABLE Supplement Publication: Applying patient-reported outcome methodology to capture patient-reported health data: report from an NIH Collaboratory roundtable7/16/2020Publication from the ADAPTABLE SupplementKevin Weinfurt; Lesley Curtis; Antonia Bennett; Mattias Jonsson; Ronald Chen; Sana Al-Khatib
ACP PEACE Study Design Paper7/6/2020ACP PEACE Study Design PaperJames Tulsky; Angelo Volandes; Joshua Lakin; Elise Brannen; Michael Paasche-Orlow; Charlotta Lindvall; Yuchiao Chang; Daniel Gundersen; Areej El-Jawahri
Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview7/6/2020Publication from the EMBED Demonstration ProjectFan Li; Edward Melnick; Patrick Heagerty; James Hughes; Karla Hemming; Monica Taljaard
PROVEN Main Outcome Paper7/6/2020PROVEN Main Outcome PaperSusan Mitchell; Angelo Volandes; Roee Gutman; Lacey Loomer; Ellen McCreedy; Vincent Mor; Pedro Gozalo; Jessica Ogarek; Ruoshui Zhai
Diagnosed prevalence of Alzheimer's disease and related dementias in Medicare Advantage plans7/5/2020Publication from the Distributed Research Network's ADRD SupplementEric Jutkowitz; Julie Bynum; Susan Mitchell; Noelle Cocoros; Oren Shapira; Kevin Haynes; Vinit Nair; Cheryl McMahill-Walraven; Richard Platt; Ellen McCarthy
Certificates of confidentiality and unexpected complications for pragmatic clinical trials6/24/2020Publication from the Ethics and Regulatory Core.Judith Carrithers; Jeremy Sugarman
Commentary: Right truncation in cluster randomized trials can attenuate the power of a marginal analysis6/1/2020Publication from the EMBED Demonstration ProjectFan Li
Association of perceived electronic health record usability with patient interactions and work-life integration among US physicians6/1/2020Publication from the EMBED Demonstration ProjectEdward Melnick
Interrupted time series of user-centered clinical decision support implementation for emergency department-initiated buprenorphine for opioid use disorder4/30/2020Publication from the EMBED Demonstration ProjectWesley Holland; Bidisha Nath; Fangyong Li; Kaitlin Maciejewski; Hyung Paek; James Dziura; Haseena Rajeevan; Charles Lu; Liliya Katsovich; Gail D'Onofrio; Edward Melnick
Experiences and insights from the early US COVID-19 epicenter: a Rapid Assessment Procedure Informed Clinical Ethnography case series4/27/2020Publication from the TSOS Demonstration ProjectKathleen Moloney; Hannah Scheuer; Allison Engstrom; Merritt Schreiber; Lauren Whiteside; Deepika Nehra; Mary Lou Walen; Frederick Rivara; Douglas Zatzick
Primary Palliative Care for Emergency Medicine (PRIM-ER): Applying form and function to a theory-based complex intervention4/24/2020Publication from the PRIM-ER Demonstration ProjectCorita Grudzen; Jacob Hill; Allison Cuthel; Philip Lin
Access to home and community health services for older adults with serious, life-limiting illness: a study protocol4/20/2020Publication from the PRIM-ER Demonstration ProjectCorita Grudzen; Jacob Hill; Allison Cuthel
Evidence from pragmatic trials — slouching toward a learning health system4/16/2020Publication from the NIH Collaboratory Coordinating CenterGregory Simon; Richard Platt; Adrian Hernandez
Using predictive analytics to improve pragmatic trial design3/10/2020Publication from the SPOT Demonstration ProjectSusan Shortreed; Gregory Simon
Progress report on EMBED: a Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder2/21/2020Publication from the EMBED Demonstration ProjectEdward Melnick; Bidisha Nath; Osama Ahmed; Cynthia Brandt; David Chartash; James Dziura; Erik Hess; Wesley Holland; Jason Hoppe; Molly Jeffery; Liliya Katsovich; Fangyong Li; Charles Lu; Kaitlin Maciejewski; Matthew Maleska; Jodi Mao; Shara Martel; Sean Michael; Hyung Paek; Mehul Patel; Timothy Platts-Mills; Haseena Rajeevan; Jessica Ray; Rachel Skains; William Soares; Ashley Deutsch; Yauheni Solad; Gail D'Onofrio
Design and analysis considerations for cohort stepped wedge cluster randomized trials with a decay correlation structure2/20/2020Publication from the EMBED Demonstration ProjectFan Li
Prospective cohort study of predictors of follow-up diagnostic colonoscopy from a pragmatic trial of FIT screening2/12/2020Publication from the STOP CRC Demonstration ProjectAmanda Petrik; Beverly Green; Gloria Coronado; Elizabeth O'Connor; Carrie Nielson
Regulation and effects of FGF23 in chronic kidney disease.2/10/2020Publication from the HiLo Demonstration ProjectMyles Wolf
ADAPTABLE Supplement Publication: Design and analytic considerations for using patient-reported health data in pragmatic clinical trials: report from an NIH Collaboratory roundtable2/6/2020Publication from the ADAPTABLE supplementFrank Rockhold; Rachel Richesson; Keith Marsolo; Emily O'Brien; Jessica Tenenbaum
Design and implementation of a clinical decision support tool for Primary Palliative Care for Emergency Medicine (PRIM-ER)1/28/2020Publication from the PRIM-ER Demonstration ProjectCorita Grudzen; Audrey Tan; Mark Durbin; Frank Chung; Ada Rubin; Allison Cuthel; Jordan McQuilkin; Aram Modrek; Catherine Jamin; Nicholas Gavin; Devin Mann; Jordan Swartz; Jonathan Austrian; Paul Testa; Jacob Hill
Interactive group-based orientation sessions: a method to improve adherence and retention in pragmatic clinical trials1/21/2020Publication from the PPACT Demonstration ProjectWilliam Vollmer; Lynn DeBar; Meghan Mayhew; Michael Leo; Michaela Kiernan
Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial1/15/2020Publication from the STOP CRC Demonstration ProjectWilliam Vollmer; Amanda Petrik; Beverly Green; Gloria Coronado; Elizabeth O'Connor
Considerations for using distributed research networks to conduct aspects of randomized trials1/2/2020Publication from the Distributed Research NetworkKeith Marsolo; Jeffrey Brown; Adrian Hernandez; Sudha Raman; Richard Platt; Lesley Curtis
MOTIFS Publication: Ethics and collateral findings in pragmatic clinical trials1/1/2020Publication from the MOTIFS supplementJeremy Sugarman; Stephanie Morain; Kevin Weinfurt; Juli Bollinger; Debra Mathews; Gail Geller
MOTIFS Publication: Response to Open Peer Commentaries on 'Ethics and collateral findings in pragmatic clinical trials'1/1/2020Publication from the MOTIFS supplementJeremy Sugarman; Stephanie Morain; Debra Mathews; Juli Bollinger
Diversity Supplement Publication: Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: race as an example1/1/2020Publication from the Diversity supplementMonique Anderson; Robert Califf; Siyun Yang; Adrian Hernandez; Robert Mentz; Kingshuk Choudhury; Elizabeth Turner; Christopher O'Connor
Hospital transfer rates among US nursing home residents with advanced illness before and after initiatives to reduce hospitalizations12/30/2019Publication from the PROVEN Demonstration ProjectLacey Loomer; Vincent Mor; Susan Mitchell
Evaluation of a Level I trauma center provider training in alcohol brief intervention delivery within a 25-site trial of screening and intervention for PTSD and related comorbidity12/29/2019Publication from the TSOS Demonstration ProjectDoyanne Darnell
Principles and procedures for data and safety monitoring in pragmatic clinical trials12/9/2019Publication from the SPOT Demonstration ProjectGregory Simon
Incidence of statin use in older adults with and without cardiovascular disease and diabetes mellitus, January 2008-March 201812/5/2019Publication from the Distributed Research Network
Clarifying the meaning of clinically meaningful benefit in clinical research: noticeable change vs valuable change12/2/2019Publication from the Patient-Reported Outcomes Core.Kevin Weinfurt
Taking opioids in times of crisis: institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S.12/1/2019Publication from the PPACT Demonstration ProjectLynn DeBar
Development and assessment of a crosswalk between ICD-9-CM and ICD-10-CM to identify patients with common pain conditions12/1/2019Publication from the PPACT Demonstration ProjectLynn DeBar
Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting: a mixed-methods examination11/28/2019Publication from the PROVEN Demonstration ProjectJennifer Palmer
Pragmatic quality assessment of brief health behavior change interventions: evidence for criterion-related validity of the Behavior Change Counseling Index11/1/2019Publication from the TSOS Demonstration ProjectDoyanne Darnell
Identifying opioid use disorder in the emergency department: multi-system electronic health record–based computable phenotype derivation and validation study10/31/2019Publication from the EMBED Demonstration ProjectEdward Melnick; David Chartash
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