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Welcome to the Knowledge Repository, a searchable collection of resources related to pragmatic clinical trials, compiled by the NIH Collaboratory Coordinating Center. For additional content and information about the NIH Collaboratory, visit www.rethinkingclinicaltrials.org.

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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 center10/20/2020Journal articlePublication from the TSOS Demonstration Project
  
Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative 10/16/2020Grand RoundsDrs. Zimmerman and Benjamin discuss the ABC Science Collaborative, which aims to unite science and schools for a data-driven solution to decision-making and implementation around mitigating COVID-19.
  
Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative 10/16/2020Grand RoundsDrs. Zimmerman and Benjamin discuss the ABC Science Collaborative, which aims to unite science and schools for a data-driven solution to decision-making and implementation around mitigating COVID-19.
  
Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) (GR Slides 2020)10/9/2020Grand RoundsDr. Wolf presents an update on HiLo, an NIDDK-funded pragmatic trial testing which phosphate treatment target provides the best clinical outcomes for patients.
  
Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) (GR Video 2020)10/9/2020Grand RoundsDr. Wolf presents an update on HiLo, an NIDDK-funded pragmatic trial testing which phosphate treatment target provides the best clinical outcomes for patients.
  
ACP PEACE Study Redesign (Details)10/7/2020Study design paperThis document describes changes to the ACP PEACE stepped-wedge study design to address effects caused by the onset of COVID-19.
  
Driving Toward Health Impact: Our Journey and Path Forward10/2/2020Grand RoundsDr. Cook presents highlights of PCORI’s 2.0 strategic plan to accelerate the impact on health care and patient outcomes.
  
Driving Toward Health Impact: Our Journey and Path Forward 10/2/2020Grand RoundsDr. Cook presents highlights of PCORI’s 2.0 strategic plan to accelerate the impact on health care and patient outcomes.
  
Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program9/25/2020Grand RoundsDrs. Fleurence and Bright describe a collaborative and innovative national effort to accelerate COVID-19 testing.
  
Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program9/25/2020Grand RoundsDrs. Fleurence and Bright describe a collaborative and innovative national effort to accelerate COVID-19 testing.
  
Estimating the Number of Self-Harm Events Not Identified by Encounter Diagnoses in Health Records9/25/2020Journal articlePreprint from the SPOT Demonstration Project
  
September 22, 2020: New Article Highlights Ethical and Regulatory Challenges of Conducting PCTs9/22/2020News articleNews article about managing regulatory noncompliance in a PCT
  
Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight 9/16/2020Journal articlePublication from the TSOS Demonstration Project and the Ethics and Regulatory Core
  
Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies 9/11/2020Grand RoundsDrs. Thomas and Bernard discuss the launch of a new network for collaborative COVID-19 research.
  
Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies 9/11/2020Grand RoundsDrs. Thomas and Bernard discuss the launch of a new network for collaborative COVID-19 research.
  
September 8, 2020: LIRE Trial Finds No Change in Healthcare Utilization, Small Drop in Opioid Prescriptions9/8/2020News articleNews article about the primary findings of the LIRE trial
  
LIRE Main Outcome Paper9/4/2020Main outcome paperLIRE Main Outcome Paper
  
Living Textbook Chapter: Assessing Fitness-for-Use of Real-World Data Sources9/3/2020ReportReal-word data must be assessed to determine whether they are fit for their intended use or purpose prior to their use in research settings. This chapter describes several approaches that can be used to facilitate such assessments.
  
September 2, 2020: Chapter on Assessing Fitness for Use of Real-World Data Sources Added to the Living Textbook9/2/2020News articleNews article about availability of a new chapter on real-world data sources
  
September 1, 2020: New Publication Explores Stakeholder Perspectives on Collateral Findings in Pragmatic Clinical Trials9/1/2020News articleNews article about collateral findings in PCTs
  
Living Textbook Chapter: Acquiring Real-World Data9/1/2020ReportThis chapter outlines strategies for obtaining real-world data for use in research.
  
August 31, 2020: Newly Validated Sample Size Formula Detects Heterogeneity of Treatment Effect in Cluster Randomized Trials8/31/2020News articleNews article about sample size formula
  
MOTIFS Publication: Stakeholder perspectives regarding pragmatic clinical trial collateral findings8/28/2020Journal articlePublication from the MOTIFS supplement
  
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting8/28/2020Grand RoundsDrs. Lentz, Curtis, and Rockhold present discussions and findings from a think tank meeting about challenges and best practices for PCTs.
  
Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting8/28/2020Grand RoundsDrs. Lentz, Curtis, and Rockhold present discussions and findings from a think tank meeting about challenges and best practices for PCTs.
  
August 27, 2020: Chapter on Acquiring Real-World Data Added to the Living Textbook8/27/2020News articleNews article about availability of a new chapter on obtaining real-world data for use in research
  
August 26, 2020: New Publication on Patients’ Views About Disclosure of Collateral Findings in Pragmatic Clinical Trials8/26/2020News articleNews article about collateral findings in PCTs
  
Diversity Supplement Publication: Sample size requirements for detecting treatment effect heterogeneity in cluster randomized trials8/21/2020Journal articlePublication from the Diversity supplement
  
Adaptive Platform Trials: Scalable from Breast Cancer to COVID8/21/2020Grand RoundsDr. Esserman discusses how the innovative adaptive platform trial, I-SPY COVID, will be used to evaluate and prioritize high-impact treatments for COVID-19.
  
Adaptive Platform Trials: Scalable from Breast Cancer to COVID 8/21/2020Grand RoundsDr. Esserman discusses how the innovative adaptive platform trial, I-SPY COVID, will be used to evaluate and prioritize high-impact treatments for COVID-19.
  
NIH Collaboratory Publications Policy8/20/2020PolicyThis document describes the NIH Collaboratory Publications and Presentations Policy.
  
NIH Collaboratory Publications and Presentations Policy Handout8/20/2020PolicyThis document shows the NIH Collaboratory publications and presentations review process.
  
MOTIFS Publication: Patients' views about the disclosure of collateral findings in pragmatic clinical trials: a focus group study8/19/2020Journal articlePublication from the MOTIFS supplement
  
Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (GR Slides 2020)8/14/2020Grand RoundsDrs. Cheville and Tilburt describe the pilot year of NOHARM, an NIH Collaboratory Demonstration Project in the NIH HEAL Initiative’s PRISM portfolio.
  
Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial (GR Video 2020)8/14/2020Grand RoundsDrs. Cheville and Tilburt describe the pilot year of NOHARM, an NIH Collaboratory Demonstration Project in the NIH HEAL Initiative’s PRISM portfolio.
  
ePCT Factsheet 20208/12/2020HandoutDouble-sided information sheet about the NIH Collaboratory and pragmatic clinical trials
  
The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research 8/7/2020Grand RoundsDr. Gibson discusses how open access, patient empowerment, social media, and digital health are transforming clinical trials.
  
The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research 8/7/2020Grand RoundsDr. Gibson discusses how open access, patient empowerment, social media, and digital health are transforming clinical trials.
  
The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research8/7/2020TranscriptDr. Gibson discusses open access and the democratization of medicine.
  
The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research8/7/2020PodcastDr. Gibson discusses open access and the democratization of medicine.
  
August 6, 2020: New Living Textbook Section Describes Rapid Approach for Implementation Assessments8/6/2020News articleNews article about availability of a new chapter on TSOS and rapid assessments
  
A pragmatic approach to psychometric comparisons between the DSM-IV and DSM-5 Posttraumatic Stress Disorder (PTSD) Checklists in acutely injured trauma patients8/6/2020Journal articlePublication from the TSOS Demonstration Project
  
Living Textbook Chapter: Dissemination and Implementation: Pragmatic Implementation Process Assessments8/4/2020ReportThis section describes a pragmatic implementation process assessment was developed by the Trauma Survivors Outcomes & Support (TSOS) pragmatic trial research team: Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE).
  
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 US8/3/2020Journal articlePublication from the EMBED Demonstration Project
  
August 3, 2020: Study Using EMBED Data Finds Drop in Emergency Department Visits During COVID-19 Pandemic8/3/2020News articleNews article about a publication describing the EMBED Demonstration Project and COVID-19
  
Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative7/31/2020Grand RoundsDrs. Raman and Sheehan present recommendations and resources from CTTI for using real-world data for planning clinical trial recruitment.
  
Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative7/31/2020Grand RoundsDrs. Raman and Sheehan present recommendations and resources from CTTI for using real-world data for planning clinical trial recruitment.
  
NIH-Collaboratory-Program-Overview7/27/2020PresentationA PDF presentation of the Collaboratory’s goals and organizational structure along with a brief introduction of each Demonstration Project
  
TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (GR Slides 2020)7/24/2020Grand RoundsDrs. Crofford and Sluka describe the neurobiology behind fibromyalgia and the aims of their embedded pragmatic trial, Fibromyalgia TENS in Physical Therapy Study (FM TIPS), an NIH Collaboratory Demonstration Project.
  
TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (GR Video 2020)7/24/2020Grand RoundsDrs. Crofford and Sluka describe the neurobiology behind fibromyalgia and the aims of their embedded pragmatic trial, Fibromyalgia TENS in Physical Therapy Study (FM TIPS), an NIH Collaboratory Demonstration Project.
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