Building Data Capacity for Patient-Centered Outcomes Research Interim Report 3 - A Comprehensive Ecosystem for PCOR (2022) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 5-16
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 5... ...
This research is frequently focused on analyzing existing data to address questions and provide objective information for the purpose of informing real-world health care decisions. BACKGROUND The legal framework that established funding for research on the outcomes and effectiveness of treatments and health care interventions dates back to the 2003 Medicare Prescription Drug, Improvement, and Modernization Act.
|
From page 6... ...
of the Public Health Service Act instructed the Secretary of HHS to … provide for the coordination of relevant Federal health programs to build data capacity for comparative clinical effectiveness research, includ ing the development and use of clinical registries and health outcomes research networks, in order to develop and maintain a comprehensive, interoperable data network to collect, link, and analyze data on out 1 https://www.ssa.gov/OP_Home/ssact/title11/1181.htm.
|
From page 7... ...
As the coordinating agency for the data infrastructure investment portfolio across HHS agencies, ASPE guides the PCOR data infrastructure's strategic framework and vision, sets funding priorities, and coordinates interagency workgroups. ASPE's work is assisted by a Leadership C ouncil for the PCOR Trust Fund, which includes representatives from other HHS agencies, including the Administration for Children and Families; the Administration for Community Living; AHRQ; the Assistant Secretary for Preparedness and Response; the Centers for Disease Control and Prevention (CDC)
|
From page 8... ...
Examples of primary data collected as part of research studies include data from clinical trials and data from national health surveys. Other examples of data sources include • Medicare or Medicaid claims data, • quality or outcomes data collected by health care providers for the purposes of improving health care value, • FDA data on the safety of medications and medical devices, and • CDC data on births and deaths provided by state public health authorities.
|
From page 9... ...
FIGURE 1-2 The Office of the Assistant Secretary for Planning and Evaluation's strategic framework for the patient-centered outcomes r esearch data infrastructure. 9 SOURCE: Workshop presentation by ASPE, May 3, 2021.
|
From page 10... ...
Use of Clinical Data for Research Researchers will be able to utilize and analyze routinely collected clinical data for implementation of clinical studies (observational and interventional) , including data relevant to assessing safety, efficacy, and adherence, as well as genetic data and patient-reported outcomes.
|
From page 11... ...
data infrastruc ture that ensures productivity, protects the patient and the patient's data, ensures that evidence generation remains in the center of PCOR, and ensures the use of agreed upon standards and services. Services refer to resources that entities can employ on demand to capture, store, or exchange either PCOR data or evidence through a centrally hosted model provided remotely (such as through the Internet)
|
From page 12... ...
The study is part of a broader initiative by ASPE intended to update the strategic plan in light of the reauthorization of the PCOR Trust Fund and advances in health information technology and interoperability tools in recent years. The study is a collaboration of three units of the National A cademies: the Committee on National Statistics, the Board on Health Care Services, and the Computer Science and Telecommunications Board.
|
From page 13... ...
• Assess anticipated changes to health care priorities and priorities for health data and their impact on building data capacity into the foreseeable future, as identified by ASPE. • Evaluate the feasibility and utility of developing a phased-in approach to building the interoperable data capacity for patient-centered outcomes research with existing databases in Department of Health and Human Services, other federal departments, and the private sector in a phased approach, such as projects identified in the Cures Act Title III Section 4003 (Interoperability)
|
From page 14... ...
To collect additional stakeholder input, members of the public were invited to provide comments on topics related to the workshop (or any other topic related to the committee's charge) , using a public input form available on the National Academies website.
|
From page 15... ...
INTRODUCTION 15 The conclusions are based primarily on the input collected as part of the workshop, background documentation received from ASPE and other public sources, and the committee members' synthesis and expert judgment. Because this is an interim report, the committee's conclusions at this stage are big-picture conclusions, which will be integrated with additional input over the course of the study.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.