Danielle Whicher
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View article: A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development
A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development Open
The Centers for Medicare and Medicaid Services' coverage with evidence development (CED) policy allows the agency to provide coverage for an item or service through a National Coverage Determination (NCD), conditional upon an agreement to …
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
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Editorial Board Open
View article: Editorial Board
Editorial Board Open
View article: Editorial Board
Editorial Board Open
View article: Rethinking ethical oversight in the era of the learning health system
Rethinking ethical oversight in the era of the learning health system Open
Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have…
View article: Equity, Inclusivity, and Innovative Digital Technologies to Improve Adolescent and Young Adult Health
Equity, Inclusivity, and Innovative Digital Technologies to Improve Adolescent and Young Adult Health Open
The author Yuval Harari opined, "humans were always far better at inventing tools than using them wisely" [[1]Hariri Y.N. 21 lessons for the 21st century. Speigel & Grau, New York2018Google Scholar]. The "tool" to which this caution is mos…
View article: Individual Patient-Level Data Sharing for Continuous Learning: A Strategy for Trial Data Sharing
Individual Patient-Level Data Sharing for Continuous Learning: A Strategy for Trial Data Sharing Open
Initiated in 2013, the YODA Project is a voluntary, industry-supported eff ort to promote open science and data sharing.This
View article: What Should Oversight of Clinical Decision Support Systems Look Like?
What Should Oversight of Clinical Decision Support Systems Look Like? Open
A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinician…
View article: An overview of the impact of rare disease characteristics on research methodology
An overview of the impact of rare disease characteristics on research methodology Open
View article: Users’ Guide to Integrating Patient-Reported Outcomes in Electronic Health Records
Users’ Guide to Integrating Patient-Reported Outcomes in Electronic Health Records Open
This Users' Guide will facilitate integration of patient-reported outcomes (PROs) in the electronic health record (EHR), enabling use of PRO data for multiple clinical, research, and administrative applications, and thereby promoting patie…
View article: List of Contributors
List of Contributors Open
View article: The Patient-Centered Outcomes Research Institute
The Patient-Centered Outcomes Research Institute Open
The Patient-Centered Outcomes Research Institute (PCORI) was created in 2010 to fund patient-centered comparative effectiveness research (CER) that evaluates interventions currently used in clinical practice to address questions of importa…
View article: Alternative consent models for comparative effectiveness studies: Views of patients from two institutions
Alternative consent models for comparative effectiveness studies: Views of patients from two institutions Open
Background: Informed consent requirements generally require a lengthy process and signed documentation for patients to participate in clinical research. With growing interest in comparative effectiveness research (CER), whereby patients re…
View article: Gatekeepers for pragmatic clinical trials
Gatekeepers for pragmatic clinical trials Open
To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gateke…