Patient-Centered Outcomes Research Trust Fund Reports

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Vignettes

• 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.

Annual Reports of the OS PCORTF Portfolio

• 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.

• 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.

• 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.

• 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.

Project Reports

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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, the output of the project is found on the FDA website here.
  Appendix

• 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.

• 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).

• 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.

Other Reports

• 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.