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     Collaboratory Products

     
      
      
      
      
    Count= 176
    Li F et al Stat Med 2017An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes.5/24/2018This article discusses statistical properties of model-based and randomization-based tests under both simple and constrained randomization designs, with varying degrees of analysis-based covariate adjustment.
    NIH-Collaboratory-Program-Overview-SlidesNIH Collaboratory Program Overview Slides5/21/2018This slide set presents an overview of the NIH Health Care Systems Research Collaboratory program mission, goals, and structure. Opens as PDF.
    NIH-Collaboratory-Program-Overview-SlidesNIH Collaboratory Program Overview Slides5/21/2018This slide set presents an overview of the NIH Health Care Systems Research Collaboratory program mission, goals, and structure. Opens as PowerPoint slides.
    Electronic Participant Guide-April 2018ePCT Training Workshop Participant Guide4/24/2018This document contains the slide sets, handouts, and resources that accompany the pilot training workshop (Feb 2018).
    PPACT- Protocol for a pragmatic cluster randomized trialPPACT- Protocol for a pragmatic cluster randomized trial4/2/2018Study design publication for the Collaboratory PPACT Demonstration Project
    PCT Reporting Template-2018-04-04PCT Reporting Template4/4/2018This resource offers guidance for the transparent reporting of embedded pragmatic clinical trial results.
    Topic 10-Worksheet-FinalTopic 10-Worksheet2/21/2018Worksheet to accompany exercise in Topic 10-Developing a Compelling Application-next steps.
    Topic 2-Worksheet-FinalTopic 2-Worksheet2/20/2018Worksheet to accompany exercise in Topic 2-Stakeholders and Health Systems
    ePCT Workshop Agenda2018 ePCT Workshop Agenda2/20/2018Agenda for the 2-day pilot ePCT Training Workshop (February 20-21, 2018)
    Topic 10-Developing an ePCT ApplicationTopic 10-Developing an ePCT Application2/21/20182018 ePCT Training Workshop Pilot: Topic 10 describes considerations and best practices for developing a compelling application for an embedded PCT study.
    Topic 9-Study Team CompositionTopic 9-Study Team Composition2/21/20182018 ePCT Training Workshop Pilot: Topic 9 discusses the ideal team composition for embedded PCT study teams.
    Topic 8-DisseminationTopic 8-Dissemination2/21/20182018 ePCT Training Workshop Pilot: Topic 8 explains disseminaton and implementation frameworks.
    Topic 7-Pilot+FeasibilityTopic 7-Pilot+Feasibility2/21/20182018 ePCT Training Workshop Pilot: Topic 7 describes considerations for conducting effective pilot & feasibility testing before the trial implementation phase.
    Topic 6-Measuring OutcomesTopic 6-Measuring Outcomes2/21/20182018 ePCT Training Workshop Pilot: Topic 6 describes considerations for determining endpoints and outcomes in ePCTs.
    Topic 5-Regulatory+EthicsTopic 5-Regulatory+Ethics2/20/20182018 ePCT Training Workshop Pilot: Topic 5 describes considerations for regulatory and ethical issues of ePCTs.
    Topic 4-Design+AnalysisTopic 4-Design+Analysis2/20/20182018 ePCT Training Workshop Pilot: Topic 4 describes randomization schemes, varieties fo cluster randomization, and other considerations in the design of ePCTs.
    Topic 3-ImplementationTopic 3-Implementation2/20/20182018 ePCT Training Workshop Pilot: Topic 3 introduces methods for keeping implementation in mind when designing ePCTs.
    Topic 2-Stakeholders+Health SystemsTopic 2-Stakeholders+Health Systems2/20/20182018 ePCT Training Workshop Pilot: Topic 2 describes considerations for study teams when engaging stakeholders and healthcare system leadership.
    Topic 1-Embedded PCTsTopic 1-Embedded PCTs2/20/20182018 ePCT Training Workshop Pilot: Topic 1 describes the characteristics of embedded pragmatic clinical trials (ePCTs) and further explores the 2 case studies, TSOS and STOP CRC.
    Introduction to Case StudiesIntroduction to Case Studies2/20/20182018 ePCT Training Workshop Pilot: This slide set introduces the 2 Collaboratory Case Studies.
    ADAPTABLE ROUNDTABLE SUMMARY_1_22ADAPTABLE ROUNDTABLE SUMMARY2/26/2018This document summarizes the ADAPTABLE Roundtable meeting, which was convened to examine how to integrate patient-reported health data with EHR data for PCTs.
    Assessing-data-quality-brief-versionAssessing Data Quality of Clinical Data for PCTs2/15/2018This document highlights recommendations for assessing the quality of data generated from routine patient care for use in PCTs.
    Coronado GD, et al. J Gen Intern Med 2017Effect of Reminding Patients to Complete Fecal Immunochemical Testing: A Comparative Effectiveness Study of Automated and Live Approaches.10/10/2017This article compares the effectiveness of different forms of reminders for a direct-mail fecal immunochemical test (FIT) program.
    LowEducationSES-Demographic Dataset - Low Education (8 of 8)1/3/2018Dataset for linking socioeconomic status (SES) and demographic characteristics to EHR data - low education
    PovertySES-Demographic Dataset - Poverty (7 of 8)1/3/2018Dataset for linking socioeconomic status (SES) and demographic characteristics to EHR data - poverty
    Transformation2SES-Demographic Dataset - Transformation and Geodata (6 of 8)1/3/2018Dataset for linking socioeconomic status (SES) and demographic characteristics to EHR data - transformation and geodata
    TSOS 2017-SnapshotTSOS Study Snapshot12/18/2017Study snapshot is a 2-page summary of the Trauma Survivors Outcomes and Support (TSOS) PCT
    TIME 2017-SnapshotTiME Study Snapshot12/18/2017Study snapshot is a 2-page summary of the Time to Reduce Mortality in End-Stage Renal Disease (TiME) PCT
    STOP CRC 2017-SnapshotSTOP CRC Study Snapshot12/18/2017Study snapshot is a 2-page summary of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) PCT
    SPOT 2017-SnapshotSPOT Study Snapshot12/18/2017Study snapshot is a 2-page summary of the Suicide Prevention Outreach Trial (SPOT) PCT
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     External Resources

     
      
      
      
    Count= 150
      
    4/13/2018Dr. George Hripcsak discusses OHDSI and how to draw reproducible conclusions from observational EHR data
      
    4/10/2018Searchable list of articles related to engagement in research
      
    3/6/2018Article describing current funding and training opportunities for health system researchers, along with challenges and future directions
      
    9/22/2017A webinar by Thomas Carton and Joanna Ball on the PCORnet Commons' current use and future use and review core features of the site
      
    8/29/2017A webinar by Kathleen McTigue, MD; Karen Coleman, Phd; Roni Zeiger, MD; and Kathryn Burn covering learnings from the PCORnet Bariatric Study project team on including stakeholders in our project
      
    7/11/2017A webinar presented by Kathleen McTigue on how the PaTH network has developed an archive of patient stories to support the development of people-centered research questions in PCORnet and facilitate patient engagement in patient-centered outcomes research
      
    10/23/2017A webinar by a panel of presenters with real-world experience implementing electronic consent within PCORnet.
      
    8/15/2017Changes in Coding of Suicide Attempts or Self-Harm With Transition From ICD-9 to ICD-10
      
    8/15/2017PCORI User Guide to Integrating Patient-Reported Outcomes in Electronic Health Records
      
    6/8/2017A webinar by Joseph M. Coe, MPA, and M. Patricia McAdams, MS, on how to use social media to raise awareness and build community
      
    5/4/2017A webinar by John Muench, MD, MPH, and Thuy Le, MPH, describing current efforts to organize the ADVANCE Clinical Data Research Network electronic health record data
      
    4/4/2017A webinar presented by Dr. Sue Friedman, Founder and Executive Director of FORCE and Co-PI of the ABOUT Patient Powered Research Network
      
    3/7/2017A webinar presented by Michael Weiner, MD, Ronald Peterson, MD, PhD, and Rachel Nosheny, PhD, on the Alzheimer's patient-powered research network tool to facilitate patient-centered clinical research
      
    1/31/2017A webinar presented by Consuelo H. Wilkins, MD, MSCI, on the components of diversity and a review of engaged research approaches needed to address disparities
      
    3/7/2017A discussion paper from the National Academy of Medicine (NAM) that highlights priorities for active engagement of frontline clinicians to advance a learning health system
      
    1/6/2017A free NIH online course on designing and analyzing pragmatic group-randomized trials
      
    8/24/2016An article in Clinical Research in Cardiology summarizing how collaboration among academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of EHRs in clinical research
      
    3/1/2016An article in Circulation highlighting potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggesting strategies to streamline study conduct in an ethical manner
      
    12/8/2016An article in the New England Journal of Medicine proposing how the term “real-world evidence” should be understood so that this type of research can fulfill its potential to inform and improve healthcare
      
    11/17/2016An article in the New England Journal of Medicine summarizing highlights from the HHS Final Rule on reporting of results in ClinicalTrials.gov
      
    3/22/2016An article describing the need for collaborations with bidirectional data exchange within and across distributed research networks, using examples from Sentinel, PCORnet, and NIH Research Collaboratory
      
    9/16/2016A presentation on engaging patients as partners throughout the research process in a way that fosters trust
      
    3/28/2016Summary and materials from a PCORnet workshop on building trustworthiness in clinical research initiatives
      
    6/28/2016A presentation on the Alzheimer’s & Dementia Patient & Caregiver-Powered Research Network (Alzheimer’s PPRN) and their methods for patient-centered dementia research
      
    7/20/2016A presentation on PCORnet's Colorado Patient Partners in Research Network's experience and tips for reaching stakeholders through social media by Sarah Madrid and Susan Moore, PhD, MSPH
      
    10/19/2016A presentation on strategies for patient outreach and recruitment by Mitchel Lunn, MD, PI of PRIDEnet and Benjamin Nowell, PhD, Co-PI of AR-PoWER, two of PCORnet's Patient-Powered Research Networks (PPRNs)
      
    11/3/2016A presentation on Becoming a PCORnet Brand Ambassador by Lindsay Singler, Julie Schulman, and Jennifer Cook, members of the PCORnet Communications team
      
    7/5/2016Special issue of eGEMs (Generating Evidence & Methods to improve patient outcomes), an open access journal, exploring strategic uses of evidence to transform healthcare delivery systems
      
    9/3/2015An article in Applied Clinical Trials reporting the results of a Clinical Trials Transformation Initiative (CTTI) survey on barriers and potential solutions for clinical trial recruitment
      
    6/1/2016Information on clinical trial regulations country by country, collated by Duke Clinical Research Institute's Regulatory Services
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     Grand Rounds

     
      
      
      
      
    Presenter
    Collaboratory Affiliation
    Clinical Trial Data Sharing: Perspectives from Participants and PCORISlides7/13/2018
    Policy & Priorities: Rethinking University Research with State Data Slides6/29/2018McKethan, AaronDuke Margolis Center
    Pragmatic Trial Design to Study Health Policy Interventions. Lessons Learned from ARTEMISSlides6/22/2018Wang, TracyDuke Clinical Research Institute
    Implementation in the PROVEN Trial - Challenges of Conducting PCTs in Nursing Home Health Care SystemsSlides6/8/2018Mitchell, Susan; Volandes, AngeloBrown University School of Medicine; Harvard Medical School; Massachusetts General Hospital
    GR-Slides-06-01-18Slides6/1/2018
    The PCORnet Antibiotics and Childhood Growth Study: Toward PCORnet Research ReadinessSlides5/18/2018Forrest, Christopher; Bailey, Charles; Block, JasonHarvard Medical School; Children's Hospital of Philadelphia; University of Pennsylvania
    Launching the NESTcc Data Network to Improve the use of Real-World Evidence in the Medical Device Ecosystem Slides5/11/2018Fleurence, RachaelNational Evaluation System for health Technology Coordinating Center (NESTcc)
    Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment and RetentionSlides5/4/2018Harris, Paul; Wilkins, Consuelo; Jones, PatriciaVanderbilt University; National Center for Advancing Translational Sciences (NCATS); Meharry-Vanderbilt Alliance
    Expanding Use of Real-World EvidenceA National Academies Workshop SeriesSlides4/27/2018Simon, GregoryKaiser Permanente Washington Health Research Institute
    The Trauma Survivors Outcomes & Support (TSOS) Trial as an ePCT Training Case StudySlides4/20/2018Zatzick, DouglasUniversity of Washington
    OHDSI: Drawing reproducible conclusions from observational clinical dataSlides4/13/2018Hripcsak, George
    Legal and Ethical Architecture for PCOR DataSlides4/6/2018Cartwright-Smith, Lara; Gray, Elizabeth; Thorpe, Jane
    HHS-DoD-VA Pain Management CollaboratorySlides3/30/2018Kerns, RobertYale University School of Medicine
    Data Science in the Era of Data UbiquitySlides3/23/2018Califf, RobertDuke Clinical Research Institute; Verily
    Straight from the Source: Clinicians’ Views on Participating in CER/PCORSlides3/16/2018Tunis, Sean; Tambor, Ellen; Moloney, RachaelCenter for Medical Technology Policy (CMTP)
    Closing the Loop in Research/Care-Delivery Partnerships: Communication and Dissemination in Learning Health SystemsSlides3/9/2018Kaiser Permanente Washington Health Research Institute
    Distributed Research Network Querying: A Status ReportSlides3/2/2018Curtis, Lesley; Brown, Jeffrey; Platt, RichardHarvard Medical School
    Direct Mail Programs Work… But Will Health Centers Implement Them? Findings from STOP CRCSlides2/23/2018Coronado, Gloria; Green, BeverlyKaiser Permanente Center for Health Research; Kaiser Permanente Washington Health Research Institute
    Considerations for the Return of Genomic ResultsSlides2/16/2018Faucett, Andrew; Rehm, HeidiHarvard Medical School
    Linking Design to Analysis of Cluster Randomized Trials: Covariate Balancing Strategieshttps://www.nihcollaboratory.org/Pages/GR-Slides-2-9-18.pdf2/9/2018Duke University
    Early Progress on the All of Us Research ProgramSlides2/2/2018Denny, JoshuaVanderbilt University
    The Lumbar Imaging with Reporting of Epidemiology (LIRE) Trial: Subsequent Cross-Sectional Imaging Through 90 Days—Preliminary ResultsSlides1/26/2018Heagerty, Patrick; Jarvik, JeffreyUniversity of Washington
    The Healthcare Pivot: Technology and Transformation of HealthcareSlides1/19/2018Schulman, KevinDuke Clinical Research Institute
    Behavioral Economic Principles to Understand and Change Clinician BehaviorSlides1/12/2018
    IMPACT-AFib: An 80,000 person Randomized Trial Using the Sentinel Initiative Platform Slides1/5/2018Platt, Richard; Cocoros, Noelle; Granger, Christopher; Pokorney, Sean
    Does Machine LearningHave a PlaceIn a Learning Health System?Slides12/15/2017Pencina, Michael
    Data and Safety Monitoring in Pragmatic Clinical Trials 12/8/2017Sugarman, Jeremy; Simon, Gregory; Ellenberg, Susan
    Providing a Shared Repository of Detailed Clinical Models for all of Health and Healthcare 12/1/2017Huff. Stanley; Hammond, Ed
    ICD-Pieces: From Planning to Performance11/17/2017Vazquez, Miguel; Oliver, GeorgeUT Southwestern Medical Center
    Results from the ABATE Infection Trial 11/3/2017Huang, Susan; Septimus, EdUniversity of California, Irvine; Hospital Corporation of America (HCA) Clinical Services Group
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     Stakeholder Interviews

     
      
    Presenter
      
      
    Count= 51
    PI-Tips-Interview-20172/14/2018Three PIs offer tips for investigators new to the conduct of embedded pragmatic clinical trials
    Sugarman-Weinfurt-Interview-2017Sugarman, Jeremy; Weinfurt, Kevin11/21/2017Jeremy Sugarman, MD, MPH, and Kevin Weinfurt, PhD, reflect on the first 5 years of the Regulatory/Ethics Core.
    Weinfurt-Interview-2017Weinfurt, Kevin11/17/2017Kevin Weinfurt, PhD, reflects on the first 5 years of the PRO Core.
    Vazquez-Interview-2017Vazquez, Miguel11/3/2017An interview with Dr. Vazquez, PI of ICD-Pieces
    Zatzick-Interview-2017Zatzick, Douglas10/27/2017An interview with Dr. Doug Zatzick, PI of the TSOS trial
    Mor-Interview-2017Mor, Vincent10/20/2017An interview with Dr. Vincent Mor, co-PI of PROVEN
    DeLong-Interview-2017DeLong, Elizabeth10/18/2017Liz DeLong, PhD, reflects on the first 5 years of the NIH Collaboratory's Biostatistics and Study Design Core.
    Tambor-Interview-2017Tambor, Ellen10/16/2017Ellen Tambor, a member of the Stakeholder Engagement Core, reflects on the first 5 years of the Core’s work and the challenges ahead.
    Richesson-Hammond-Interview-2017Hammond, W. Ed; Richesson, Rachel10/10/2017Rachel Richesson, PhD, and W. Ed Hammond, PhD, reflect on the first 5 years of the Phenotypes, Data Standards, and Data Quality Core.
    Dember-Larson-Interview-8-27-15Larson, Eric; Dember, Laura8/27/2015Laura Dember, MD, and Eric Larson, MD, MPH, discuss lessons learned in the TiME UH3 Demonstration Project.
    DeBar PPACT Interview 7-27-15DeBar, Lynn7/27/2015Lynn DeBar, PhD, of Kaiser Permanente Center for Health Research, discusses lessons learned in the PPACT UH3 Demonstration Project.
    Jarvik LIRE Interview 7-21-15Jarvik, Jeffrey7/21/2015Jerry Jarvik, MD, MPH, of the University of Washington, discusses lessons learned in the LIRE UH3 Demonstration Project.
    Stakeholder-Interview-Hernandez-Weinfurt-Curtis-04-20-15Curtis, Lesley; Hernandez, Adrian; Weinfurt, Kevin4/20/2015Adrian Hernandez, MD, MHS, Kevin Weinfurt, PhD, and Lesley Curtis, PhD, of Duke University, discuss the future of the NIH Collaboratory at the April 2015 Steering Committee Meeting.
    Coronado Green STOP CRC Interview 6-17-15Coronado, Gloria6/17/2015Gloria Coronado, PhD, of Kaiser Permanente Center for Health Research, and Beverly Green, MD, MPH, of Group Health Research Institute, discuss lessons learned in the STOP CRC UH3 Demonstration Project.
    Simon Interview SPOT 6-11-15Simon, Gregory6/12/2015Greg Simon, MD, MPH, of Group Health Research Institute, discusses lessons learned in the SPOT UH3 Demonstration Project.
    Video-Interview-DeLong-04-20-15DeLong, Elizabeth4/20/2015Liz DeLong, PhD, MA, of Duke University, discusses lessons learned in the NIH Collaboratory’s Biostatistics and Study Design Core at the April 2015 Steering Committee Meeting.
    Video-Interview-Larson-Jarvik-04-20-15Larson, Eric; Jarvik, Jeffrey4/20/2015Eric B. Larson, MD, MPH, of Group Health Research Institute, and Jerry Jarvik, MD, MPH, of the University of Washington, discuss the LIRE Demonstration Project at the April 2015 Steering Committee Meeting.
    Video-Interview-Hammond-04-20-15Hammond, W. Ed4/20/2015W. Ed Hammond, PhD, of Duke University, discusses the work of the NIH Collaboratory’s Phenotypes, Data Standards, and Data Quality Core at the April 2015 Steering Committee Meeting.
    Video-Interview-Vazquez-04-20-15Vazquez, Miguel4/20/2015Miguel Vazquez, MD, of UT Southwestern, discusses progress of the ICD-Pieces Demonstration Project at the April 2015 Steering Committee Meeting.
    Video-Interview-Weinfurt-04-20-15Weinfurt, Kevin4/20/2015Kevin Weinfurt, PhD, of Duke University, discusses the work of the NIH Collaboratory’s Patient-Reported Outcomes Core at the April 2015 Steering Committee Meeting.
    Video-Interview-Zatzick-4-20-15Zatzick, Douglas4/20/2015Douglas Zatzick, MD, of the University of Washington, discusses progress of the TSOS Demonstration Project at the April 2015 Steering Committee Meeting.
    Video-Interview-Larson-Johnson-04-21-15Larson, Eric; Johnson, Karin5/22/2015Eric B. Larson, MD, MPH, and Karin Johnson, PhD, of Group Health Research Institute, discuss lessons learned in the Health Care Systems Interactions Core at the April 2015 Steering Committee Meeting.
    Video-Interview-Mor-04-20-15Mor, Vincent4/20/2015Vincent Mor, PhD, of Brown University, discusses progress of the PROVEN Demonstration Project at the April 2015 Steering Committee Meeting.
    Video-Interview-Platt-Hernandez-04-20-15Platt, Richard; Hernandez, AdrianAdrian Hernandez, MD, MHS, of Duke Clinical Research Institute, and Richard Platt, MD, of Harvard Pilgrim Health Care Institute, discuss knowledge transfer between the NIH Collaboratory and PCORnet at the April 2015 Steering Committee Meeting.
    Video-Interview-Tunis-04-20-15Tunis, Sean4/20/2015Sean Tunis, MD, MSc, of the Center for Medical Technology Policy, discusses the work of the NIH Collaboratory's Stakeholder Engagement Core at the April 2015 Steering Committee Meeting.
    Video-Interview-Briggs-04-20-15Briggs, Josephine4/20/2015Josephine Briggs, MD, of the National Center for Complementary and Integrative Health, discusses the impact of the NIH Collaboratory at the April 2015 Steering Committee Meeting.
    video-interview_WeinfurtWeinfurt, KevinKevin Weinfurt, PhD, discusses the work of the Patient-Reported Outcomes core.
    Video-interview_CurtisCurtis, LesleyLesley Curtis, PhD, discusses the Distributed Research Network.
    Video-interview_HammondHammond, W. EdEd Hammond, PhD, discusses the Phenotypes, Data Standards, and Data Quality core
    video-interview_TunisTunis, SeanSean Tunis, MD, MSC, discusses the work of the Stakeholder Engagement core.
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