Document Type
  
Topics
  
Count= 185
ACP PEACE Regulatory-Ethics Consultation Minutes-UG3-August 2018.pdf
  
ACP PEACE Regulatory-Ethics UG3 Materials9/7/2018This document contains the meeting minutes for the Regulatory/Ethics Core consultation and supplementary materials for the ACP PEACE Demonstration Project.Clinical research; Pragmatic clinical trial; Regulatory issues; Research ethics
ePCT-Factsheet.pdf
  
ePCT Factsheet8/30/2018A PDF infographic introducing the elements of the NIH Collaboratory and the value of engaging in pragmatic research
NIH-Collaboratory-Program-Overview.pdf
  
NIH Collaboratory Program Overview 8/30/2018A PDF presentation of the Collaboratory’s goals and organizational structure along with a brief introduction of each Demonstration Project
ePCT-Essentials-Worksheet.pdf
  
ePCT Training Workshop2/1/2018The inaugural in-person workshop conducted in February 2018 to provide training to mid- and senior-level investigators interested in conducting embedded pragmatic clinical trials (ePCTs), and to collect feedback on the quality and appropriateness of the m
ePCT-Essentials.pdf
  
ePCT-Essentials 8/30/2018Important things to think about and do when designing, conducting, and disseminating embedded PCTsInteractive Resource
ABATE Decolonization Protocol FINAL.pdf
  
ABATE Decolonization Protocol8/30/2018This document describes the protocol for the decolonization arm in the ABATE Infection pragmatic trial.Text; ToolkitClinical research; Cluster randomized trial; Comparative effectiveness research; Patient-centered research; Outcomes research; Research dissemination; Pragmatic clinical trial
ABATE Routine Care Protocol FINAL.pdf
  
ABATE Routine Care Protocol8/30/2018This document describes the protocol for the routine care arm in the ABATE Infection pragmatic trial.Text; ToolkitClinical research; Cluster randomized trial; Comparative effectiveness research; Patient-centered research; Outcomes research; Research dissemination; Pragmatic clinical trial
NIH_collaboratory_24AUG2018.pdf
  
ADAPTABLE Supplement Patient-Reported Health Data Standards-2018-07-19.pdf
  
ADAPTABLE Supplement Report: Patient-Reported Health Data and Metadata Standards in the ADAPTABLE Study7/19/2018This report summarizes the results of a literature review of data standards and metadata standards for variables of interest to the ADAPTABLE trial. Opens as a PDF. Comparative effectiveness research; Data quality; Data standards and interoperability; Patient-centered research; Electronic health records
Li F et al Stat Med 2017.aspx
  
An 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. Clinical research; Study design
NIH-Collaboratory-Program-Overview-Slides.pdf
  
NIH 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.PresentationClinical research; Pragmatic clinical trial; Study design
NIH-Collaboratory-Program-Overview-Slides.pptx
  
NIH 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.PresentationClinical research; Pragmatic clinical trial; Study design
Electronic Participant Guide-April 2018.pdf
  
ePCT Training Workshop Participant Guide4/24/2018This document contains the slide sets, handouts, and resources that accompany the pilot training workshop (Feb 2018).Clinical research; Cluster randomized trial; Data quality; Electronic health records; Implementation; Learning healthcare system; Pragmatic clinical trial; Provider-health system interactions; Research dissemination; Research ethics; Study design; Stakeholder engagement
PPACT- Protocol for a pragmatic cluster randomized trial.aspx
  
PPACT- Protocol for a pragmatic cluster randomized trial4/2/2018Study design publication for the Collaboratory PPACT Demonstration ProjectPragmatic clinical trial; Study design
PCT Reporting Template-2018-04-04.pdf
  
PCT Reporting Template4/4/2018This resource offers guidance for the transparent reporting of embedded pragmatic clinical trial results.Clinical research; Data quality; Electronic health records; Electronic phenotypes; Pragmatic clinical trial; Provider-health system interactions; Research dissemination; Study design; Stakeholder engagement
Topic 10-Worksheet-Final.pdf
  
Topic 10-Worksheet2/21/2018Worksheet to accompany exercise in Topic 10-Developing a Compelling Application-next steps.Clinical research; Pragmatic clinical trial; Study design
Topic 2-Worksheet-Final.pdf
  
Topic 2-Worksheet2/20/2018Worksheet to accompany exercise in Topic 2-Stakeholders and Health SystemsClinical research; Learning healthcare system; Pragmatic clinical trial
ePCT Workshop Agenda.pdf
  
2018 ePCT Workshop Agenda2/20/2018Agenda for the 2-day pilot ePCT Training Workshop (February 20-21, 2018)Clinical research; Pragmatic clinical trial; Study design
Topic 10-Developing an ePCT Application.pdf
  
Topic 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.Clinical research; Learning healthcare system; Network policies & governance; Translational research; Regulatory issues
Topic 9-Study Team Composition.pdf
  
Topic 9-Study Team Composition2/21/20182018 ePCT Training Workshop Pilot: Topic 9 discusses the ideal team composition for embedded PCT study teams.Clinical research; Study design; Provider-health system interactions
Topic 8-Dissemination.pdf
  
Topic 8-Dissemination2/21/20182018 ePCT Training Workshop Pilot: Topic 8 explains disseminaton and implementation frameworks.Clinical research; Cluster randomized trial; Implementation; Learning healthcare system; Research dissemination; Study design; Translational research
Topic 7-Pilot+Feasibility.pdf
  
Topic 7-Pilot+Feasibility2/21/20182018 ePCT Training Workshop Pilot: Topic 7 describes considerations for conducting effective pilot & feasibility testing before the trial implementation phase. Clinical research; Learning healthcare system; Implementation; Quality improvement; Pragmatic clinical trial; Stakeholder engagement
Topic 6-Measuring Outcomes.pdf
  
Topic 6-Measuring Outcomes2/21/20182018 ePCT Training Workshop Pilot: Topic 6 describes considerations for determining endpoints and outcomes in ePCTs.Clinical research; Cluster randomized trial; Data quality; Data standards and interoperability; Outcomes research; Electronic phenotypes; Electronic health records; Pragmatic clinical trial; Study design
Topic 5-Regulatory+Ethics.pdf
  
Topic 5-Regulatory+Ethics2/20/20182018 ePCT Training Workshop Pilot: Topic 5 describes considerations for regulatory and ethical issues of ePCTs.Clinical research; Data privacy & security; Informed consent and human subjects protection; Network policies & governance; Research ethics; Pragmatic clinical trial
Topic 4-Design+Analysis.pdf
  
Topic 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. Clinical research; Cluster randomized trial; Data analysis; Pragmatic clinical trial; Study design; Biostatistics
Topic 3-Implementation.pdf
  
Topic 3-Implementation2/20/20182018 ePCT Training Workshop Pilot: Topic 3 introduces methods for keeping implementation in mind when designing ePCTs.Clinical research; Cluster randomized trial; Electronic health records; Implementation; Learning healthcare system; Study design
Topic 2-Stakeholders+Health Systems.pdf
  
Topic 2-Stakeholders+Health Systems2/20/20182018 ePCT Training Workshop Pilot: Topic 2 describes considerations for study teams when engaging stakeholders and healthcare system leadership.Clinical research; Learning healthcare system; Provider-health system interactions; Pragmatic clinical trial; Quality improvement; Stakeholder engagement
Topic 1-Embedded PCTs.pdf
  
Topic 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.Clinical research; Electronic health records; Pragmatic clinical trial; Study design; Learning healthcare system
Introduction to Case Studies.pdf
  
Introduction to Case Studies2/20/20182018 ePCT Training Workshop Pilot: This slide set introduces the 2 Collaboratory Case Studies.Clinical research; Learning healthcare system; Electronic health records; Pragmatic clinical trial; Study design
ADAPTABLE ROUNDTABLE SUMMARY_1_22.pdf
  
ADAPTABLE 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. TextElectronic health records; Patient-centered research; Patient-reported outcomes
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