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Living Textbook Copyright Policy Final 4-28-17.pdf
  
Copyright Policies for Rethinking Clinical Trials®: A Living Textbook of Pragmatic Clinical Trials4/28/2017This document details the NIH Collaboratory's policies on original content created for the Living Textbook as well as contributorship definitions, how to obtain permission, and the minimal attribution elements.Clinical research; Implementation; Research dissemination; Pragmatic clinical trial
Living Textbook Pubs Agreement Final 4-28.pdf
  
Publication Agreement for NIH Collaboratory Living Textbook4/28/2017This document details the publication agreement between the Collaboratory and contributors of materials created for publication in Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials.Clinical research; Implementation; Pragmatic clinical trial; Research dissemination
Zatzick DF et al. Psychiatr Serv 2017.aspx
  
The Cumulative Burden of Mental, Substance Use, and General Medical Disorders and Rehospitalization and Mortality After an Injury2/1/2017This article describes associations between comorbid mental, substance use, and general medical disorders, TBI, and violent events or suicide attempts and the postinjury outcomes of recurrent hospitalization and death.Clinical research; Cluster randomized trial; Learning healthcare system; Outcomes research; Implementation; Pragmatic clinical trial
Simon GE et al. Trials 2016.aspx
  
Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial9/15/2016This article describes a multisite trial of two outreach programs to prevent suicide attempts among outpatients identified by routinely administered PHQ9 questionnaires.Clinical research; Comparative effectiveness research; Outcomes research; Pragmatic clinical trial
Mor V et al. Clin Trials 2017.aspx
  
PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting1/1/2017This article presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems.Clinical research; Cluster randomized trial; Outcomes research; Pragmatic clinical trial; Study design
Richesson RL et al. J Am Med Inform Assoc 2017.aspx
  
Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory3/14/2017This article describes the informatics challenges of conducting pragmatic clinical trials (PCTs) and proposes policy and research actions to facilitate the future conduct of PCTs. Clinical research; Data standards and interoperability; Learning healthcare system; Informatics; Electronic phenotypes; Electronic health records; Pragmatic clinical trial
NIH Collaboratory DRN Solicitation for Query Requests (v3.0).pdf
  
NIH Collaboratory Distributed Research Network: Query Requests1/25/2017NIH Collaboratory invites requests to query the Distributed Research Network. This document contains details on how to get started.Clinical research; Data analysis; Data sharing; Data standards and interoperability; Distributed research network; Electronic health records; Electronic phenotypes; Informatics
Zozus MN et al. AMIA Jt Summits Transl Sci Proc 2016.aspx
  
Research Reproducibility in Longitudinal Multi-Center Studies Using Data from Electronic Health Records7/20/2016An article in the Proceedings-AMIA Joint Summits on Translational Science describing a framework to support the much-needed discussion of strategies to ensure the reproducibility of research that uses data from EHRsElectronic health records; Clinical research; Study design; Translational research
Petrik AF et al. Fam Pract 2016.aspx
  
The validation of electronic health records in accurately identifying patients eligible for colorectal cancer screening in safety net clinics7/28/2016Article from the STOP CRC demonstration project assessing the accuracy of EHR codes in identifying patients eligible for colorectal cancer screening. Findings highlight the importance of better capture of past screening events in the EHR. Clinical research; Electronic health records; Informatics
Dember LM et al. J Am Soc Nephrol 2016.aspx
  
Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative10/31/2016Experience from the TiME demonstration project, a large cluster-randomized, pragmatic trial evaluating hemodialysis session duration, to illustrate challenges and solutions to operational, ethical, and regulatory issues.Cluster randomized trial; Clinical research; Comparative effectiveness research; Learning healthcare system; Pragmatic clinical trial; Provider-health system interactions; Research ethics
Moloney RM et al. J Comp Eff Res 2016.aspx
  
Patient and clinician support for the learning healthcare system: recommendations for enhancing value3/1/2016Article from the NIH Collaboratory Stakeholder Engagement Core with clinician and patient perspectives for enhancing the value of a learning healthcare system.Learning healthcare system; Patient engagement; Stakeholder engagement; Provider-health system interactions
Cook AJ et al. Clin Trials 2016.aspx
  
Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core10/1/2016Article from the NIH Collaboratory Biostatistics and Study Design Core on statistical lessons learned designing pragmatic cluster randomized trials.Biostatistics; Cluster randomized trial; Study design; Pragmatic clinical trial
AMWA-PCT-Dissemination.pdf
  
Generating Real-World Evidence: The Emergence of Pragmatic Clinical Trials10/7/2016This presentation explores the unique challenges and opportunities for scientific communicators engaged in disseminating findings from pragmatic clinical trials.TextPragmatic clinical trial; Research dissemination
AMWA_poster_writing_team.pdf
  
Evaluation of a Workshop-Based Approach to Writing a Theme Issue of an Academic Journal10/7/2016Evaluating a workshop-based approach to writing twelve articles about the ethical and regulatory issues of pragmatic clinical trials for a theme issue of the academic journal Clinical Trials.Conference; Still ImagePragmatic clinical trial; Regulatory issues; Research dissemination
PROVEN_MorMitchellVolandes_UH3_Follow-up.pdf
  
PROVEN ethics and regulatory documentation - UH3 project updates8/31/2016This document contains updates from the PROVEN Demonstration Project ethics and regulatory discussions.Clinical research; Informed consent and human subjects protection; Pragmatic clinical trial; Regulatory issues
ICDPieces_Vazquez_UH3_Follow-up.pdf
  
ICD-Pieces ethics and regulatory documentation - UH3 project updates8/31/2016This document contains updates from the ICD-Pieces Demonstration Project ethics and regulatory discussions.Clinical research; Informed consent and human subjects protection; Pragmatic clinical trial; Regulatory issues
TSOS_Zatzick_UH3_Follow-up.pdf
  
TSOS ethics and regulatory documentation - UH3 project updates8/30/2016This document contains updates from the TSOS Demonstration Project ethics and regulatory discussions.Clinical research; Informed consent and human subjects protection; Pragmatic clinical trial; Regulatory issues
PCT Reporting Template-2017-01-26.pdf
  
PCT Reporting Template1/26/2017This document is a tool for authors to use in reporting their pragmatic clinical trial.Template; ToolkitCluster randomized trial; Distributed research network; Data quality; Informed consent and human subjects protection; Electronic phenotypes; Electronic health records; Pragmatic clinical trial; Stakeholder engagement; Research dissemination; Study design
Richesson R et al. Artif Intell Med 2016.aspx
  
Clinical phenotyping in selected national networks: demonstrating the need for high-throughput, portable, and computational methods7/1/2016This article summarizes approaches to clinical phenotyping from EHR data based on experiences with national networks, including the NIH Collaboratory.Electronic phenotypes; Informatics
Richesson R et al. eGEMs.aspx
  
A Framework to Support the Sharing and Re-Use of Computable Phenotype Definitions Across Health Care Delivery and Clinical Research Applications7/5/2016Members of the Phenotypes, Data Standards, and Data Quality core envision an infrastructure that facilitates re-use of computable phenotypes in a learning healthcare system.Data analysis; Data standards and interoperability
Topazian R et al. J Comp Eff Res.aspx
  
Physicians' Perspectives Regarding Pragmatic Clinical Trials7/15/2016This article examines clinicians’ views on participating in pragmatic clinical research. Clinical research; Stakeholder engagement; Provider-health system interactions; Study design
Collaboratory Publications Process Handout.pdf
  
Collaboratory Publications Process Handout4/29/2016A handout describing the process to follow for Collaboratory publications, both from Cores/Working Groups and Demonstration Projects.Network policies & governance
Zatzick DF et al. Implement Sci 2016.aspx
  
An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity5/18/2016An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidityClinical research; Cluster randomized trial; Comparative effectiveness research; Pragmatic clinical trial; Study design; Implementation
Patient Bathing Video from the ABATE Infection Project.aspx
  
Patient Bathing Video from the ABATE Infection Project5/5/2016The ABATE study team developed a training video to teach nurses and nursing assistants how to approach patients to administer a chlorhexidine (CHG) cloth bed bath, or help patients take a shower using the liquid CHG soap.Clinical research; Comparative effectiveness research; Pragmatic clinical trial; Cluster randomized trial
NIH Collaboratory Resources Handout.pdf
  
NIH Collaboratory Resources Handout3/17/2016A handout describing resources available on the NIH Collaboratory website and Living Textbook for designing and conducting pragmatic clinical trials.Pragmatic clinical trial
Sugarman J. AJOB Empir Bioeth 2016.aspx
  
Ethics of Research in Usual Care Settings: Data on Point2/10/2016Author introduces a special 5-article supplement on the emerging body of literature on the ethics of research on medical practices.Comparative effectiveness research; Patient engagement; Informed consent and human subjects protection; Pragmatic clinical trial; Research ethics
Weinfurt K et al. AJOB Empir Bioeth 2015.aspx
  
Patients’ Views Concerning Research on Medical Practices: Implications for Consent 11/15/2015This article describes the results of focus group sessions that elicited a range of patients' views and opinions about different types of research on usual medical practices. Informed consent and human subjects protection; Patient engagement; Pragmatic clinical trial; Research ethics
Sugarman J. Am J Bioeth 2015.aspx
  
Is Shared Decision Making an Appropriate Analytic Frame for Research on Medical Practices?9/1/2015Author discusses the role of shared decision making (SDM) in research on medical practices. The author cautions that “while SDM is in many ways similar to informed consent, there are some important differences, especially in the research setting.” Comparative effectiveness research; Patient engagement; Informed consent and human subjects protection; Research ethics; Pragmatic clinical trial
Sugarman J. Acad Med 2016.aspx
  
Ethics and Regulatory Challenges and Opportunities in Patient-Centered Comparative Effectiveness Research1/27/2016This article discusses emerging ethics and regulatory challenges and opportunities in pragmatic research efforts.Comparative effectiveness research; Informed consent and human subjects protection; Patient-centered research; Research ethics; Regulatory issues
Vollmer WM et al. EGEMS 2015.aspx
  
Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems12/9/2015This article describes practical solutions to analytic issues in the STOP CRC trial.Cluster randomized trial; Data analysis; Electronic health records; Pragmatic clinical trial; Study design
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