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OS-PCORTF Product Library

The projects in the OS-PCORTF portfolio support the development of a wide and diverse array of products and services intended to expand or strengthen federal data capacity for patient-centered outcomes research. The OS-PCORTF Product Library, complemented by the product descriptions in the completed projects in the OS-PCORTF Project Portfolio, presents the most comprehensive view of the products produced by OS-PCORTF projects.

Please bookmark this page -- new products will be added as projects are completed.

The products are open for public and governmental uses, although attribution may be required for some resources; certain data holders may charge user fees for access. Products may be at different stages of maturity upon completion of project support from the OS-PCORTF.

Product Types:

Project Outputs by Product Category Project and Portfolio Reports, Profiles, and Evaluations
Datasets and Databases (including linked data) Project Reports and Briefs
Data Elements & Information Models Vignettes, Project Spotlights, and Portfolio Reports
HIT Standards Annual Reports
Tools and Guides Evaluation Reports
Software and Analytic Services  
Data Governance Products  
Publications  

Datasets and Databases


Linked National Hospital Care Survey (NHCS) and National Death Index (NDI) Mortality Data

The linked NHCS data with the NDI mortality data provides the opportunity to conduct a vast array of outcome studies designed to investigate the association of a wide variety of health factors with mortality. The linked datasets include 2014 NHCS linked to 2014-2015 NDI Mortality Data and the 2016 NHCS linked to 2016-2017 NDI Mortality Data.

Product Type: Linked dataset
Year Released: 2018 & 2019
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: Dataset information and access requirements


Linked NHCS and CMS Medicare Master Beneficiary Summary File (MBSF) Data

The 2014 NHCS has been linked to the 2014-2015 CMS Medicare Master Beneficiary Summary File (MBSF). The linked data allows for new analyses, such as examining comorbidities and utilization of non-inpatient-related health care services.

Product Type: Linked dataset
Year Released: 2019
Project: Project Description
Agency: Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services
Link: Dataset information and access requirements


Linked NHCS and CMS Medicare MBSF Claims/Encounters and Assessment Data

The 2016 NHCS has been linked to the 2016-2017 CMS Medicare MBSF, Claims/Encounters, and Assessment data. The linked dataset provides the opportunity to conduct a vast array of studies on health care utilization and expenditures among the elderly U.S. population and persons receiving Medicare disability benefits.

Product Type: Linked dataset
Year Released: 2020
Project: Project Description
Agency: Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services
Link: Dataset information and access requirements


NHCS and NDI linked with the National Vital Statistics System mortality files on drug overdose deaths (NVSS-M-DO) file

The dataset includes the following: 1) Merged 2014 NHCS/NDI/NVSS-M-DO, and 2) Merged 2016 NHCS/NDI/NVSS-M-DO. Analysis of this data set will result in a report exploring characteristics of individuals who have opioid-related events, patterns of hospital use in months prior to death, and comparison of patients and services.

Product Type: Linked dataset
Year Released: 2020
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: Read more about the linkage


AHRQ Social Determinants of Health Database (Beta Version)

The purpose of this project is to create easy to use, easily linkable SDOH-focused data to use in PCOR research, inform approaches to address emerging health issues, and ultimately contribute to improved health outcomes. These SDOH beta data files are curated from existing Federal datasets and other publicly available data sources. The purpose of the files is to make it easier to find a range of well documented, readily linkable SDOH variables across domains without having to access multiple source files, facilitating SDOH research and analysis.

Product Type: Database
Year Released: 2020
Project: Project Description
Agency: Agency for Healthcare Research and Quality
Link: Read more about the linkable database


Data Elements & Information Models


GitHub Annotations for 1,000 Vaccine Adverse Event Reporting System (VAERS) Reports

The FDA project team initiated and completed the generation of an annotated corpus to support training and development efforts of language models. The complete clinical and temporal annotations for the 1,000 Vaccine Adverse Event Reporting System (VAERS) reports are publicly available to the research community on GitHub.

Product Type: Data / Technical Product
Year Released: 2018
Project: Project Description
Agency: Food and Drug Administration
Link: GitHub Code


Libraries of Clinical Definitions for Outcome Measures

AHRQ publicly posted clinical definitions (“Standardized Library”) of outcome measures in five clinical areas, including (1) Atrial fibrillation, (2) Asthma, (3) Depression, (4) Lung cancer, and (5) Lumbar spondylolisthesis on its Effective Healthcare Program website.

Product Type: Data / Technical Product
Year Released: 2018-2021
Project: Project Description
Agency: Agency for Healthcare Research and Quality (AHRQ)
Link: View Definitions


NIH Common Data Elements Repository

The NIH Common Data Elements (CDE) Repository provides access to structured human and machine-readable definitions of data elements that have been recommended or required by NIH Institutes and Centers and other organizations for use in research and for other purposes.

Product Type: Data / Technical Product
Year Released: 2015
Project: Project Description
Agency: National Institutes of Health (NIH)
Link: View Resource


HIT Standards


Logical Observation Identifiers Names and Codes (LOINC) Equivalence Class Artifact Releases

The project team created three releases of a LOINC Equivalence Class artifact. The first version, LOINC Group File Alpha 1, was released June 2017 (LOINC release 2.61), containing 12 Parent Groups and 2,178 Groups that aggregate a total 6,438 unique LOINC terms. LOINC Group File Alpha 2 was released December 2017 (LOINC release 2.63). It contained 21 Parent Groups, 4,100+ equivalence groups that aggregate more than 17,500 unique LOINC terms. The final version was released June 2018 as LOINC Group File Beta 1 (LOINC release 2.64) and contains 36 parent groups, containing 5,650 groups that organize 24,075 unique LOINC terms. Releases are available in the LOINC release archive.

Product Type: Terminology standard guide
Year Released: 2017
Project: Project Description
Agency: National Institutes of Health
Link: View Product


HL7 Version 2.6 Implementation Guide: Vital Records Death Reporting, Release 1 STU 2 - US Realm

This document provides a technical messaging specification for transmitting death related information using the HL7 Version 2.6 ADT Update Patient Information. The project aims to enable interoperable electronic data exchanges among electronic health record systems, U.S. vital records systems and the national statistical agency, National Center for Health Statistics (NCHS). The use cases represented within this implementation guide (IG) describe the technical requirements for reporting death from a clinical setting to the jurisdictional vital records office that sends vital records information to NCHS. Additionally, the document provides support for NCHS to report information back to the jurisdictional vital records office.

Product Type: HL7 Implementation guide
Year Released:
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Product


Common Data Models Harmonization FHIR Implementation Guide (Release 0.1.0)

This FHIR Implementation Guide will focus on mapping and translating observational data extracted from different research networks for PCOR purposes into FHIR format.

Product Type: HL7 Implementation guide
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology​​​
Link: View Product


Women’s Health Technology CRN FHIR Implementation Guide

The Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) FHIR Implementation Guide (IG) will focus on capturing and exchanging data related to women’s health.

Product Type: HL7 Implementation guide
Year Released:
Project: Project Description
Agency: Food and Drug Administration | National Institutes of Health | Office of the National Coordinator for Health Information Technology
Link: View Product


Patient Reported Outcomes FHIR Implementation Guide

The Patient Reported Outcomes (PRO) FHIR Implementation Guide (IG) will focus on capturing and exchanging patient reported outcome data electronically using the FHIR standard (Release 0.2.0).

Product Type: HL7 Implementation guide
Year Released:
Project: Project Description
Agency: Agency for Health Research and Quality | Office of the National Coordinator for Health Information Technology
Link: View Product


The HAPI Open-Source FHIR® library

This is the homepage for the HAPI-FHIR library, which is developing an open-source implementation of the FHIR (Fast Healthcare Interoperability Resources) specification in Java in order to support the exchange of healthcare data in a modern and developer friendly way.

Product Type: Other documentations related to HIT standards
Year Released:
Project: Project Description
Agency: National Institutes of Health
Link: View Product


Tools and Guides


Natural Language Processing Clinical Language Engineering Workbench (CLEW) User Guidance Document

This document explains how to install and use the Clinical Language Engineering Workbench (CLEW) and products developed in the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) pilots.

Product Type: Manual/user guide
Year Released: 2019
Project: Project Description
Agency: Centers for Medicare & Medicaid Services | Food and Drug Administration
Link: View Report


Data Quality Metrics (DQM) Tool

The Data Quality Metrics (DQM) tool provides a harmonized approach to data characterization across multiple data sources to enable researchers to better assess data source comparability and fitness-for-use. The system operationalizes existing data quality (DQ) parameters and methodologies in a way that is compatible across Common Data Models (CDMs) and data sources. This data model and data source agnostic approach enables the DQM application to facilitate research planning and compare data characteristics across any data source.

Product Type: Toolkit
Year Released: 2019
Project: Project Description
Agency: Food and Drug Administration
Link: View Product


Electronic Death Reporting System (EDRS) Online Reference Manual

This document is a resource guide for jurisdictions to support development and sustainability of EDRS.

Product Type: Implementation/roll-out guide
Year Released: 2016
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Product


Conceptualizing a Data Infrastructure for the Capture, Use, and Sharing of Patient-Generated Health Data in Care Delivery and Research through 2024 Practical Guide

This document is a practical guide that offers suggested practices and questions to consider for the implementation of the capture, use, and sharing of patient-generated health data in clinical and research settings. Depending on the size of the clinical or research organization (e.g., large health system, solo practitioner), considerations or requirements that influence how the guide is applied at that organization may differ.

Product Type: Implementation/roll-out guide
Year Released: 2018
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


Cross-Network Directory Service (CNDS) Project Design and Technical Documentation

The CNDS Project Design and Technical Documentation provides background, architectural overview, and requirements and testing.

Product Type: System documentation
Year Released: 2018
Project: Project Description
Agency: Food and Drug Administration
Link: View Product


Utilizing Data from Various Partners in a Distributed Manner

The purpose of this project, Utilizing Data from Various Partners in a Distributed Manner was to develop and test the capability to conduct rapid and secure distributed regression analysis utilizing data for different people that are held at different institutions (horizontally partitioned). In addition, it explored the feasibility of creating a virtual linkage capability to utilize data about a single person that is held at different institutions (vertically partitioned). The goal of the project was to enable research sites within a distributed research network to maintain control of patient-level data while generating valid regression estimates across the network without the need to transfer sensitive information.

Product Type: Methods documentation
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Report


Source Data Capture From EHRS: Using Standardized Clinical Research Data

This report describes the methods and tools to automate the flow of structured electronic health record data into external systems and thereby reduce operating costs, save time, and improve data quality for clinical trials. It is based on a collaboration between investigators at the University of California San Francisco (UCSF) and FDA.

Product Type: Tools and Guides
Year Released:
Project: Project Description
Agency: Centers for Medicare & Medicaid Services
Link: View Report


NLP CLEW Workbench Web Service Technical Report

This report presents a detailed technical description of the core NLP approach of the prototype version of the Workbench and two pilot applications developed using the Workbench. In doing so, the core motivating use cases for NLP across a range of clinical domains were explored. The tools and constituent components that are available as part of the prototype are described.

Product Type: Technical documentation
Year Released:
Project: Project Description
Agency: Food and Drug Administration | Centers for Disease Control and Prevention
Link: View Report


Software and Analytic Services


Blue Button 2.0 Application Programming Interface (API) Developer Sandbox

The Blue Button Sandbox is a place where users can build, and test applications using synthetic sample beneficiary data and get up and running with the Blue Button 2.0 API.

Product Type: Development environment
Year Released: 2016
Project: Project Description
Agency: Centers for Medicare & Medicaid Services
Link: View Product


CMS Blue Button Webpage and API Developer Environment

This webpage houses the CMS Blue Button Application Programming Interface (API) developer environment. Blue Button 2.0 is a standards-based API that delivers Medicare Part A, B, and D data for over 60 million Medicare beneficiaries.

Product Type: Development environment
Year Released:
Project: Project Description
Agency: Centers for Medicare & Medicaid Services
Link: View Product


Patient Matching, Aggregation, and Linking (PMAL) Provider Data Validation Tool

This repository contains a number of command-line utilities and related code libraries for parsing, creating, and validating US-based health provider data. Tools include: parsing, indexing, pulling/loading, and utility scripts. These resources can be used to validate FHIR documents prior to, or at the point of, submission.

Product Type: Data management platform
Year Released: 2017
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


FDA MyStudies App

The FDA MyStudies app lets patients provide data that can be linked to traditional clinical trials, real-world trials, observational studies, and registries. This repository contains the code and documentation for running the FDA MyStudies mobile application, web configuration portal, and storage environment.

​​​​Product Type: Mobile Application (source code)
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Product


Clinical Language Engineering Workbench (CLEW) Platform

The CLEW allows the clinical natural language processing community to collaborate and share their work in a central repository. This could enable development of NLP and machine-learning solutions to provide high-quality structured data for clinical, academic, government, and public health organizations. It could also minimize duplication in the development of solutions and expand the availability of tools and services to additional clinical domains.

Product Type: Development environment
Year Released:
Project: Project Description
Agency: Centers for Disease Control and Prevention | Food and Drug Administration
Link: Contact cancerinformatics@cdc.gov


Distributed Regression Analysis (DRA) source code and documentation for the algorithms, and test data and samples reports for each regression model type

The DRA was fully integrated into the 2017 PopMedNet™ release and the new version of the software is available on www.popmednet.org and on Sentinel’s website. In addition to source code and documentation for the algorithms, the Sentinel website also provides test data and sample reports for each regression model type.

Product Type: Analytic codes
Year Released: 2018
Project: Project Description
Agency: Food and Drug Administration
Link: View Product


National Plan & Provider Enumeration System (NPPES) Open Application Programming Interface (API)

This API is an alternative to the downloadable NPPES data files. It allows systems to access NPPES public data in real-time, rather than through batched uploads. The API retrieves data from NPPES daily.

Product Type: Application programming interface (API)
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


​​​​Identity Matching Adjudicator Collector (IMAC) Tool

The IMAC is a matching algorithm that was modified and used in a pilot as part of this project. Open-source code for the tool is available in GitHub.

Product Type: Algorithmic codes
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


Data Governance Products


Legal and Ethical Framework to Use Centers for Disease Control and Prevention Data for Patient-Centered Outcomes Research

This paper offers a legal and ethical framework to navigate the legal and ethical challenges of allowing CDC’s data to be used for PCOR. It outlines the legal restrictions on CDC to answer the question “what can CDC do to support PCOR?” It also offers the ethical guardrails for CDC to consider the question “what should CDC do to support PCOR?” Both legal and ethical considerations are essential to CDC in this process.

Product Type: Legal and ethical framework
Year Released: 2018
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Product


Legal and Ethical Architecture for Patient-Centered Outcomes Research (PCOR) Data (“Architecture”)

This Architecture is a collection of tools and resources that help researchers and others navigate an overview of the legal requirements related to data use, sharing, and disclosure for PCOR. Specifically, the Architecture: a) provides a common structure and model for the analysis of legal requirements and ethical consideration and responsibilities in research, particularly PCOR; b) supports PCOR by illustrating pathways to collect and share data for research that is in compliance with relevant federal laws and regulations and in consideration of state law; and c) supports a culture of trust among stakeholders by applying meaningful and appropriate privacy and security parameters.

Product Type: Legal and ethical framework
Year Released: 2020
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


Pilot of a Data Quality Framework to Support Patient Matching

This report is based on a pilot performed to test the Data Quality Framework for Patient Matching Framework. The implementation considerations in this paper are intended to assist organizations in implementing the PDDQ Framework (or the Ambulatory Guide) and to encourage their contributions to developing additional resources to improve the quality of demographic data and patient matching. The PDDQ Framework provides guidance for the standardization of policies, processes, procedures, and practices both locally at the clinic level and across an entire health care system. The framework includes standards and processes to help health care organizations improve the quality of patient demographic data by preventing the creation of duplicate patient records and helping them better manage existing duplicate records.

Product Type: Data quality guide/framework
Year Released: 2019
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Product


Publications


Considerations for Building Federal Data Capacity for Patient-Centered Outcomes Research Related to Intellectual and Developmental Disabilities

Product Type: Report
Year Released: 2021
Link: Read the report


Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes

Brown D, Srinivasan M, Arbulu L, Dullabh P, Curtis K, Zott C, and Smith SR.

Product Type: Report
Year Released: 2021
Link: Read the report


Harmonized outcome measures for use in depression patient registries and clinical practice

Richard E Gliklich, Michelle B Leavy, Lisa Cosgrove, Gregory E Simon, Bradley N Gaynes, Lars E Peterson, Bryan Olin, Collette Cole, J Raymond DePaulo Jr, Philip Wang, Chris M Crowe, Cristina Cusin, Mary Nix, Elise Berliner, Madhukar H Trivedi

Product Type: Journal article
Year Released: 2020
Project: Project Description
Agency: Agency for Healthcare Research and Quality
Link: Read the article


Harmonized outcome measures for use in asthma patient registries and clinical practice

Richard E Gliklich, Mario Castro, Michelle B Leavy, Valerie G Press, Amisha Barochia, Christopher L Carroll, Julie Harris, Sarah S Rittner, Robert Freishtat, Reynold A Panettieri Jr, Giselle S Mosnaim

Product Type: Journal article
Year Released: 2019
Project: Project Description
Agency: Agency for Healthcare Research and Quality
Link: Read the article


Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice: endorsed by the Heart Rhythm Society Board of Trustees

Hugh Calkins, Richard E Gliklich, Michelle B Leavy, Jonathan P Piccini, Jonathan C Hsu, Sanghamitra Mohanty, William Lewis, Saman Nazarian, Mintu P Turakhia

Product Type: Journal Article
Year Released: 2019
Project: Project Description
Agency: Agency for Healthcare Research and Quality
Link: Read the article


Generation of an annotated reference standard for vaccine adverse event reports

Matthew Foster, Abhishek Pandey, Kory Kreimeyer, Taxiarchis Botsis

Product Type: Journal Article
Year Released: 2018
Project: Project Description
Agency: Centers for Disease Control and Prevention | Food and Drug Administration
Link: Read the article


Inappropriate Utilization in Fee-for-Service Medicare and Medicare Advantage Plans

Shriram Parashuram, Seung Kim, Bryan Dowd

Product Type: Journal Article
Year Released: 2018
Project: Project Description
Agency: Assistant Secretary for Planning and Evaluation
Link: Read the article


Twelve-month health care use and mortality in commercially insured young people with incident psychosis in the United States

Michael Schoenbaum, Jason M Sutherland, Andre Chappel, Susan Azrin, Amy B Goldstein, Agnes Rupp, Robert K Heinssen

Product Type: Journal Article
Year Released: 2017
Project: Project Description
Agency: Assistant Secretary for Planning and Evaluation
Link: Read the article


Natural language processing systems for capturing and standardizing unstructured clinical information: a systematic review

Kory Kreimeyer, Matthew Foster, Abhishek Pandey, Nina Arya, Gwendolyn Halford, Sandra F Jones, Richard Forshee, Mark Walderhaug, Taxiarchis Botsis

Product Type: Journal Article
Year Released: 2017
Project: Project Description
Agency: Centers for Disease Control and Prevention | Food and Drug Administration
Link: Read the article


Improving the value of clinical research through the use of common data elements

Jerry Sheehan, Steven Hirschfeld, Erin Foster, Udi Ghitza, Kerry Goetz, Joanna Karpinski, Lisa Lang, Richard P Moser, Joanne Odenkirchen, Dianne Reeves, Yaffa Rubinstein, Ellen Werner, Michael Huerta

Product Type: Journal Article
Year Released: 2016
Project: Project Description
Agency: National Institutes of Health
Link: Read the article


Project Reports and Briefs


Enhancing Data Resources for Studying Patterns and Correlates of Mortality in Patient-Centered Outcomes Research: Project 1 - Adding Cause-Specific Mortality to NCHS’s National Hospital Care Survey by Linking to the National Death Index

This final report summarizes the FY 17 OS-PCORTF project from the Centers of Disease Control and Prevention (CDC), that linked National Hospital Care Survey to the National Death Index to obtain cause-specific mortality. Cause-specific mortality is a key patient-centered outcome because it allows deaths unrelated to care to be excluded.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Report


Emergency Medicine Opioid Data Infrastructure: Key Venue to Address Opioid Morbidity and Mortality (Capturing Opioid Use Disorder Electronically and Patient-Reported Outcomes)

This report summarizes the FY 18 OS-PCORTF Project managed by the National Institutes of Health/National Institute of Drug Abuse to enhance capacity to use electronic health record (EHR) data and patient-reported outcomes measures (PROs) to conduct opioid-related research in emergency departments (EDs).

Product Type: Final Report
Year Released:
Project: Project Description
Agency: National Institutes of Health
Link: View Report


Common Data Model Harmonization Final Report

This project was a collaboration between FDA, several NIH Institutes (NCATS, NCI and NLM), and ONC. The goal of the project was to reuse data, methods, and other resources from existing research networks and to take advantage of available open, consensus-based standards, and to build reusable data mappings and transformation services. The project resulted in a Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) CDMH Implementation Guide, a data governance framework, methods and standard process for ongoing curation, validated mappings between the Common data models, a portal and clinical query software, and public access to data specifications and visualizations of the mappings.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration | National Institutes of Health | Office of the National Coordinator for Health Information Technology
Link: View Report


Office of the National Coordinator’s Privacy and Security Framework Final Report

This project was a collaboration between ONC and CDC. The goal of this project was to develop resources to support the protection of privacy and security of electronic health data as it is used for PCOR. The resources resulting from this project consider the legal and regulatory requirements relative to patient consent, privacy, and autonomy in examining the factors of collection, access, use, and disclosure of electronic health data that were current at the time of the project. The project resulted in a framework and testing of technology that support the use of health data from a wide variety of sources for PCOR.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Report


Women’s Health Coordinated Registry Network Final Report

The project was a collaboration between FDA, NIH/NLM, and ONC. The project produced several publicly available products including the Stress Urinary Incontinence (SUI) Surgery Module aimed at collecting quality data on all types of SUI surgeries, WHT-CRN Common Core Dataset; and an HL7 WHT-CRN FHIR Implementation Guide, which is a “recipe book” that provides general guidelines for how the implementation of the FHIR standard can be applied to support the capture and exchange of data among the registries.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Report


Developing a Strategically Coordinated Registry Network for Women’s Health Technologies: Office of the National Coordinator

This report summarizes the results of ONC’s work on an interagency project to develop and test a standards-based approach to establishing a new Coordinated Registry Network for women’s health technologies and to develop tools that facilitate data collection to populate registries. The ONC portion of the project resulted in the development and testing of a Health Level Seven International (HL7®) Fast Healthcare Interoperability Resource (FHIR) Implementation Guide that provides guidance regarding the capture and exchange of women’s health data by registries.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Report


Enhancing Data Resources for Studying Patterns and Correlates of Mortality in Patient-Centered Outcomes Research: Project 4 - NDI Workshop and Strategy Paper

This report summarizes the barriers to the national death index (NDI) from the Federal and State perspective, as well as the long-term strategy for NDI - on how access and use of NDI data may be improved for research. The strategy examined altering the economic model used to support NDI; de-identifying and minimizing the non-economic barriers to accessing and using NDI; re-using cause of death data (e.g., sharing the data with other research proposals; multiple use of approved data for other research studies); improving the efficiency of the administrative aspects of linkages; improving the timeliness and quality of the NDI data; and improving the timeliness of the NDI approval process.

Product Type: Other Report (strategy paper)
Year Released:
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Report


Data Quality Metrics System Final Report

This Final Report is for the Food and Drug Administration’s Data Quality Metrics Project. This project designed, tested, and released for open-source use a web-based data quality toolkit for exploring and describing the quality, completeness, and stability of data sources and visualization of data quality metrics from any data source.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Report


Advancing the Collection and Use of Patient-Reported Outcomes through Health Information Technology: Final Report

This report describes the project led by the Office of the National Coordinator for Health Information Technology (ONC) and the Agency for Healthcare Research and Quality (AHRQ) focused on standardizing the collection, exchange, and integration of patient-reported outcome (PRO) data in electronic health record (EHR) systems and other health information technology (IT) solutions to support the electronic sharing of this information.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Report


Natural Language Processing Clinical Language Engineering Workbench (CLEW) Project - Final Report

This report summarized the goals, methodologies, accomplishments and deliverables of the project.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration | Centers for Disease Control and Prevention
Link: View Report


Natural Language Processing Clinical Language Engineering Workbench (CLEW) Project - Lessons Learned

This report compiles lessons that were realized and captured while developing a natural language process (NLP) workbench. The lessons have been separated into three categories that represent overall general observations; tools, systems development, and testing; and NLP and machine learning pipeline and model development.

Product Type: Other Report (lessons learned)
Year Released:
Project: Project Description
Agency: Food and Drug Administration | Centers for Disease Control and Prevention
Link: View Report


NLP CLEW Workbench Web Service Technical Report

This report presents a detailed technical description of the core NLP approach of the prototype version of the Workbench and two pilot applications developed using the Workbench. In doing so, the core motivating use cases for NLP across a range of clinical domains were explored. The tools and constituent components that are available as part of the prototype are described.

Product Type: Technical documentation
Year Released:
Project: Project Description
Agency: Food and Drug Administration | Centers for Disease Control and Prevention
Link: View Report


Patient Matching, Aggregation, and Linking (PMAL) Project Final Report

This report explains the project, deliverables, and lessons learned in the areas of improving patient matching, improving data quality, expanding data sharing, and data standardization.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View Report


Improving the Timeliness and Quality of State Electronic Death Registration Systems

The CDC/National Center for Health Statistics (NCHS) worked with jurisdictions in 19 states to address three objectives. The project worked to strengthen both the states’ mortality data infrastructures and the NCHS infrastructure for more timely delivery of state records the National Death Index (ND) database; conducted intersystem exchanges between EHRs and electronic death registration system using national standards; and linked the National Hospital Care Survey inpatient and emergency department data with the NDI data to pilot test capturing within- and post-hospital mortality.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Centers for Disease Control and Prevention
Link: View Report


Conceptualizing a Data Infrastructure for the Capture and Use of Patient-Generated Health Data

ONC defines patient-generated health data (PGHD) as health-related data created and recorded by or from patients outside of the clinical setting to help address a health concern. The rise of innovative digital health technologies has increased the ease of capturing, using, and sharing PGHD. Although patients are creating an abundance of PGHD, several technical and cultural barriers have slowed the adoption of PGHD in care delivery and research. This report envisions a health IT ecosystem that optimizes PGHD use for care delivery and research settings and developed a Practical Guide that offers suggested practices and questions to consider for the implementation of the capture, use, and sharing of PGHD in clinical and research settings.

Product Type: White paper & infographic
Year Released:
Project: Project Description
Agency: Office of the National Coordinator for Health Information Technology
Link: View white paper and infographic


Creation of LOINC Equivalence Classes

LOINC provides standardized codes and names for a wide range of clinical observations and provides codes for the observations recorded in a spectrum of settings for diverse applications. This project’s purpose was to create a flexible, extensible, and computable mechanism for rolling up LOINC codes into clinically relevant equivalence groups that enable more efficient processing and aggregation of laboratory and other data from diverse health IT systems.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: National Institutes of Health
Link: View Report


Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned

Variation in types and definitions of outcome measures used in patient registries make it difficult to compare, link, and aggregate data across a range of registries even in the same clinical area. This project report describes the use of the Outcome Measures Framework to develop minimum sets of standardized outcome measures in five clinical areas (atrial fibrillation, asthma, depression, lung cancer, and lumbar spondylolisthesis) for use in patient registries and in clinical practice.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Agency for Healthcare Research and Quality
Link: View Report


Enhanced Data Resources for Studying Patterns and Correlates of Mortality in Patient-Centered Outcomes Research

This CMS project links CDC/NCHS National Death Index (NDI) data for known Medicare and Medicaid deaths with Medicare and Medicaid data in the CMS Chronic Conditions Warehouse (CCW). The CCW Medicare and Medicaid data includes claim and enrollment information. Linkage of NDI and CCW selected data were updated into the Master Beneficiary Summary file, the Medicaid Enrollee Supplemental file, and included in the CCW data dictionary.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Centers for Medicare & Medicaid Services
Link: View Report


Collection of Patient‐Provided Information through a Mobile Device Application for Use in Comparative Effectiveness and Drug Safety Research

This FDA project developed a mobile device application for use in clinical trials and other research. The pilot test was conducted with pregnant women although the app is applicable to a range of topics and research methodologies. The project is now known as “FDA MyStudies App”. For additional information, please refer to the Appendix. The output of the project is found on the FDA website.

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Report


Cross-Network Directory Service Project

This project creates an open-source interoperable service that allows: 1) data partners to easily participate in multiple data research networks, 2) queries to seamlessly move across such networks, and 3) users to share analytic capabilities and knowledge across networks. This project pilot tested the Cross-Network Directory Service (CNDS) across two existing networks: FDA’s Sentinel and PCORI’s National Patient-Centered Clinical Research Network (PCORnet).

Product Type: Final Report
Year Released:
Project: Project Description
Agency: Food and Drug Administration
Link: View Report


Vignettes, Project Spotlights, and Portfolio Reports


Research Data Networks and Patient-Centered Outcomes Research Trends and Opportunities: Scan and Interviews with Key Informants

This report focuses on research networks that engage in or support research on patient-centered outcomes. The report was produced as as part of the strategic planning process for the Office of the Secretary Patient-Centered Outcomes Research Trust Fund portfolio.

Product Type: Portfolio Report
Link: View Product


Addressing the Opioid Crisis through Better Data and Data Infrastructure

This vignette provides examples of how a range of OS-PCORTF cross-agency projects are working to address the opioid crisis by 1) improving the quality and timeliness of outcomes data, 2) increasing collection of patient-reported information, and 3) building linkages to address co-morbid conditions that affect patient outcomes.

Product Type: Vignette
Link: View Product


Generating Real-World Evidence by Strengthening Real-World Data Sources

This vignette provides examples of how a range of OS-PCORTF cross-agency projects are working to strengthen the availability of Real World Evidence by standardizing Real World Data sources so they are fit for use and by building linkages across sources so data are easier to share and analyze.

Product Type: Vignette
Link: View Product


Building the Data Capacity for Patient-Centered Outcomes Research: 2019 Vignettes

This report presents brief vignettes that describe highlights of projects that are funded through the OS-PCOR trust fund. The report gives illustrative examples of the value of the work that has been done in partnership with HHS agencies to build data capacity for patient-centered outcomes research. The vignette document showcases accomplishments of the portfolio and explains the usefulness of the products that project teams are producing.

Product Type: Vignette
Link: View Product


Standardizing Narrative Text for Public Health Research

This spotlight highlights a CDC project - Development of a Natural Language Processing (NLP) Web Service for Public Health. This project developed an NLP Web Service or workbench, called the Clinical Language Engineering Workbench (CLEW). CLEW is a cloud-based web service that hosts NLP and machine learning tools that researchers can use to convert unstructured clinical data into standardized coded data. Once converted, data can be analyzed for public health and clinical research and surveillance.

Product Type: Project Spotlight
Link: View Product


Data Linkage Helps Researchers Find Patterns in Opioid Use and Treatment Response among Patient’s Hospital Encounters

This spotlight highlights the National Center for Health Statistics (NCHS) within the Centers for Disease Control and Prevention (CDC) three projects to address these data infrastructure needs. Since 2017, NCHS has integrated multiple data sources to build innovative data resources that will improve researchers’ ability to analyze data on hospital care, co-occurring mental health and substance use issues, post-acute care delivery, and deaths related to opioid-involved overdose. Through utilization of these integrated data resources, researchers can gain insight on patient characteristics, patterns of care, and other risk factors that affect health outcomes in cases of opioid misuse or abuse.

Product Type: Project Spotlight
Link: View Product


Social Determinants of Health Data Sharing at the Community Level

This report represents a landscape review of community-level efforts to address SDOH, followed by interviews with participants in three community-level initiatives that have built networks to coordinate clinical and social services. This report presents a cross-site analysis of the three initiatives, highlighting factors they identified as facilitating their efforts, the challenges they have faced thus far, their plans for continued expansion, and opportunities for federal and state entities, among other actors, to contribute to their efforts.

Product Type: Portfolio Report
Link: View Product


State Data for Conducting Patient-Centered Outcomes Research to Improve Maternal Health: Stakeholder Discussions Summary Report

This report presents a summary of discussions with stakeholders conducted to identify key components of successful state-based maternal health data linkage initiatives, to recognize the gaps in implementing such initiatives including data use for research and finally to understand the current status of existing linkages of state-level data with other data sources and with electronic health records.

Product Type: Portfolio Report
Link: View Product


Challenges and Improvements for PCOR Data Infrastructure: Results from a Stakeholder Prioritization Activity

In support of the development of the OS-PCORTF Strategic Planning, ASPE sought to gather perspectives on challenges and improvements for PCOR data infrastructure from a diverse group of stakeholders—with a wide range of occupational backgrounds including policy, health care delivery, research and informatics—through an online prioritization activity. Participants first generated challenges and improvements for the five functionalities. Participants then voted on challenges and improvements within each functionality, generating a ranked list of the participant-generated ideas.

Product Type: Portfolio Report
Link: View Product


Addressing the Opioid Epidemic with Better Data: An Overview of HHS Priorities and Projects to Expand Data Capacity for Patient-Centered Outcomes Research on Opioids

This report builds on a workshop sponsored by ASPE, titled Addressing the Opioid Epidemic: Harnessing the Power of Data for Patient-Centered Research in December 2018, which showcased projects working to build the data infrastructure for patient-centered outcomes research around opioids.

Product Type: Portfolio Report
Link: View Product


Incorporating Social Determinants of Health in Electronic Health Records: A Qualitative Study of Perspectives on Current Practices Among Top Vendors

To investigate the development of software products that allow health care providers to identify and address patients SDH in health care settings, this report conducted interviews with six electronic health records (EHRs) vendors with large market shares in both ambulatory and inpatient settings. This report conducted thematic analysis of the interviews to a) identify their motivations to develop such software products, b) describe their products and uses, and c) identify facilitators and challenges to collection and use of SDH data—through their products or otherwise—either at the point of care or in population health interventions.

Product Type: Portfolio Report
Link: View Product


Building Data Capacity for Patient-Centered Outcomes Research (PCOR) for COVID-19: Highlights of Seven OS-PCORTF Funded Multiagency Data Initiatives

This report describes seven new multiagency projects to strengthen the data infrastructure for conducting patient-centered outcomes research on COVID-19, during and after the pandemic. In general, these projects either expand the use of existing data or link datasets across Federal and State sources. Some projects advance modeling using artificial intelligence (AI) and machine learning (ML) to identify subpopulations at risk for poorer outcomes, sequelae, and the impacts of care settings and community characteristics. Other projects gather critical data on the effectiveness of repurposed treatments and vaccines for COVID-19.

Product Type: Report
Link: View Report


Enhancing the Data Infrastructure for Women's Health Research to Improve Women's and Maternal Health Outcomes

This Vignette highlights OS-PCORTF projects that are developing tools to collect, standardize, link, share, and analyze women’s and maternal health data.

Product Type: Vignette
Link: View Product


Supporting Value-Based Care Transformation through Interoperability and Care Coordination

This Vignette highlights OS-PCORTF projects that help support care coordination and quality by 1) aggregating data across sources to better reflect patient voices among vulnerable populations; 2) building greater interoperability across electronic health record (EHR) systems to improve coordination across the continuum of care, and 3) linking and standardizing metrics for the collection of social determinants of health data to improve care and reduce health disparities.

Product Type: Vignette
Link: View Product


Improving Patient-Centered Outcomes Research through Better Collection and Use of Participant-Provided Information

This Participant-Provided Information (PPI) Vignette highlights OS-PCORTF projects that are working to expand data capacity or data infrastructure for the collection and use of PPI.

Product Type: Vignette
Link: View Product


Annual Reports


Building the Data Capacity for Patient-Centered Outcomes Research: The 2020 Annual Report

The OS PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 27 projects that were active in calendar year 2020, as well as the major accomplishments.

Product Type: Annual Report
Link: Full Annual Report | Executive Summary | Infographic


Building the Data Capacity for Patient-Centered Outcomes Research: The 2019 Annual Report

The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 27 projects that were active in calendar year 2019, as well as the major accomplishments.

Product Type: Annual Report
Link: Full Annual Report | Executive Summary | Infographic


Building the Data Capacity for Patient-Centered Outcomes Research: The 2018 Annual Report

The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 25 projects that were active in calendar 2018.

Product Type: Annual Report
Link: Full Annual Report


2017 Annual Report of HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research

The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 21 projects that were active in calendar year 2017.

Product Type: Annual Report
Link: Full Annual Report


2016 Annual Report of HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research

The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 18 projects that were active in calendar year 2016.

Product Type: Annual Report
Link: Full Annual Report


HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research: Completed Projects FY 2010 through FY 2015

The purpose of this document is to provide a summary of projects that were funded through the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) and completed between fiscal years (FY) 2010 and 2015.

Product Type: Annual Report
Link: Full Annual Report


Evaluation Reports


United States Government Accountability Office, Report to Congressional Committees, November 2020 Comparative Effectiveness Research

In this report, GAO reviewed the CER activities that PCORI and HHS have carried out to meet legislative requirements, described how PCORI and HHS allocated funding to CER activities, and described PCORI and HHS efforts to evaluate the effectiveness of their CER dissemination and implementation activities. The report can also be viewed by visiting: https://www.gao.gov/products/GAO-21-61.

Product Type: Evaluation Report
Link: View Report


United States Government Accountability Office, Report to Congressional Committees, March 2018 Comparative Effectiveness Research: Activities Funded by the Patient-Centered Outcomes Research Trust Fund

In this report, GAO reviewed the CER activities that PCORI and HHS have carried out to meet legislative requirements, described how PCORI and HHS allocated funding to CER activities, and described PCORI and HHS efforts to evaluate the effectiveness of their CER dissemination and implementation activities. The report can also be viewed by visiting: https://www.gao.gov/products/gao-18-311.

Product Type: Evaluation Report
Link: View Report


Building Data Capacity for Patient-Centered Outcome Research: Portfolio Highlights (2016-2019): Impact, Opportunities and Case Studies

This report summarizes the impact of the OS-PCORTF portfolio in terms of products, tools and lessons learned for future work. The report is based on an assessment of portfolio awards funded from Fiscal Year (FY) 2016 through FY 2019.

Product Type: Evaluation Report
Link: Full Report | Executive Summary


Building Data Capacity for Patient-Centered Outcomes Research in HHS: A Formative Evaluation of 2012-2016 Projects

This report is a formative evaluation of the OS-PCORTF portfolio of projects from 2012 to 2016. It summarizes achievements as well as considerations for future work to build data capacity for clinical comparative effectiveness research and patient-centered outcome research.

Product Type: Evaluation Report
Link: View Report