The ACA appropriated funds to help build the national capacity and infrastructure needed to conduct and disseminate patient-centered outcomes research (PCOR). The ultimate aim of these efforts is to allow patients, providers, and caregivers to make more informed health decisions.
OS PCORTF funds are specifically used to make multiple, coordinated investments over time in the infrastructure components (i.e., standards, services, policies, federal data, and governance structures) necessary to achieve the interoperable flow, linkage and analysis of data needed for PCOR. OS PCORTF investment decisions give particular consideration to what the Department of Health and Human Services—as a governmental entity—could uniquely contribute to the PCOR enterprise
Developing a Strategically Coordinated Registry Network (CRN) for Women’s Health Technologies (FDA in partnership with NIH/NLM and ONC)
The project goal is to create a strategically Coordinated Registry Network (CRN) for women’s health technologies that will collect patient reported outcomes and employ the standards for Structured Data Capture (SDC) from EHRs for data collection and exchange to both enhance existing registries and enrich PCOR data infrastructure pertinent to women’s health conditions.
Enhancing Data Resources for Studying Patterns and Correlates of Mortality in Patient-Centered Outcomes Research (CDC in partnership with CMS and FDA)
The project goal and objectives are the linkage of data on fact, cause, and manner of death from the National Death Index (NDI) to several federal population-based health data platforms, to demonstrate the feasibility of such linkage, enable high-value patient-centered outcomes research (PCOR) on patterns and correlates of mortality via the resulting linked data, and to facilitate collaboration between federal partners regarding strengthening the infrastructure and methods for linking healthcare data to mortality outcomes and using such linked data for PCOR.
Advancing the Collection and Use of Patient-Reported Outcomes through Health Information Technology (AHRQ in partnership with ONC)
The goal of this project is to develop technical tools for collecting and integrating patient-reported outcome (PRO) assessments into electronic health records (EHRs) or other health information technology (IT) products, by:
- Refining and/or developing health IT standards that can be used to support sharing of PRO data through APIs and relevant health IT products for research;
- Supporting the development of user-friendly, PRO-collection applications that utilize the health IT standards or APIs; and
- Implementing private/public partnerships for pilot-testing these technical tools in a health system that supports both healthcare delivery and research.
Harmonization of Various Common Data Models and Open Standards for Evidence Generation (FDA in partnership with NIH/NLM/NCI and ONC)
This goal of this project is facilitate the use of Real World Data (RWD) sources (e.g., claims, EHRs, registries, electronic Patient Reported Outcomes (ePRO)) to support evidence generation for regulatory and clinical decision making. This project will:
- Develop common data architecture as the intermediary between various Common Data Models.
- Create a sustainable, flexible, modifiable shared resource that can evolve over time with changing requirement.
- Validate the common data architecture through a specific use case that would evaluate the safety of newly approved oncology drugs which help to allow the immune system to target cancers.
Establish methods and develop processes, policies and governance for ongoing curation, maintenance and sustainability of the common data architecture, building upon existing resources, standards and tools.
Improving Beneficiaries’ Access to their Health Information through an Enhanced Blue Button Service
The enhanced Blue Button service, BBonFHIR, creates an upgraded data service that enables CMS beneficiaries to connect their MyMedicare.gov data to the applications and services they trust including research platforms. BBonFHIR creates an integration model for the industry with structured data formats and standard interfaces making it simpler for beneficiaries to automate linking their data to research studies. Researchers will be able to recruit beneficiaries to research studies by sending those recruits to a web page or mobile app that would request that a beneficiary gives the researcher access to their data at CMS. Upon agreeing to this request the beneficiary will be taken to a CMS page to authenticate and authorize the access. This dramatically simplifies acquisition and transformation of beneficiary claims information to support research studies.
Development of a Natural Language Processing (NLP) Web Service for Structuring and Standardizing Unstructured Clinical Information
While there have been strides through Meaningful Use and other activities to implement standardized electronic health record (EHR) systems, there continue to be parts of the medical record, laboratory reports, and other clinical reports that are reported in free-form text narratives. This project will develop an NLP Web Service on the Public Health Community Platform (PHCP) that will have the core functionality to accept and process unstructured textual information and return standardized common data elements and coded data from selected terminologies (ICD-9-CM, ICD-O-3, LOINC, SNOMED CT, MedDRA, etc.). This project will pilot implementation of the NLP Web Service using cancer data and surveillance data for blood products and vaccines and provide guidance to other federal agencies, public health agencies, and patient-centered outcomes researchers on how to include their domain-specific terminologies and coding rules.
Source Data Capture from EHRs: Using Standardized Clinical Research Data
This project will demonstrate a single point data capture approach from the electronic health record (EHR) to an electronic data capture system (EDC) using the Retrieve Form for Data Capture (RFD) standard. This allows data collected in the EHR to be used as part of an FDA-regulated clinical research protocol, eliminating the need for duplicate entry, and potentially saving time, money, and eliminating an opportunity for errors. This project will provide patient-centered outcomes researchers with a cloud-based, HIPAA and 21CFRPart 11-compliant tool to seamlessly integrate EHR and EDC systems.
Use of the ADAPTABLE Trial to Strengthen Methods to Collect and Integrate Patient-reported Information with Other Data Sets and Assess Its Validity
The goal of this project is to develop, pilot and evaluate methods to validate and integrate patient-reported information with data obtained from the EHR in the context of the ADAPTABLE trial, the first major randomized comparative effectiveness trial to be conducted by the National Patient-Centered Clinical Research Network. The trial encompasses several key features, including enrollment of 20,000 patients across six large health care systems; an internet portal to consent patients and collect patient-reported information regarding risk factors, medications, and experiences; and reliance on existing EHR data sources for baseline characteristics and outcomes follow-up. The project will generate tools and data standards that could be deployed in other PCOR studies beyond the ADAPTABLE trial.
Standardization and Querying of Data Quality Metrics and Characteristics for Electronic Health Data
Understanding the characteristics of a data source is critical for investigators in their determination regarding whether the data is fit for use, but currently no standards exist for describing the quality and completeness of electronic health data. Metadata standards are needed to describe the quality, completeness, and stability of data sources, and to enable metadata querying. Effective use of the growing number of data sources and distributed networks will require adoption of a uniform approach to describing the quality characteristics of electronic health data, as well as the data capture characteristics at the institutional, provider, and health plan level and data domain level. This project will develop, test, and implement a standards-based approach to describing data quality and presenting data quality metrics.
Harmonization of Clinical Data Element Definitions for Outcome Measures in Registries
Syntax and standardization of electronic formats and methods of transfer of information has been a priority for EHRs and registries. There has been much less focus on whether specific clinical definitions are the same across institutions. This project will convene a series of clinical topic specific working groups, including registry holders, EHR developers, policy makers developing quality measures and other types of mandatory reporting, clinicians, health systems, industry, FDA, CMS, AHRQ, CDC, ONC, NIH, the National Quality Forum and patients to discuss the various definitions currently used and how definitions can be harmonized in order to promote common definitions for outcome measures across data collection and reporting systems.
Precision Medicine Informatics
The goal of this project is the development of core data policies and standards essential for the Precision Medicine Initiative National Cohort, and to evaluate feasibility issues in their implementation. A core goal of the PMI is to assemble a “longitudinal cohort of 1 million or more Americans who have volunteered to participate in research.” The data infrastructure to enable the creation of this major national resource is expected to exert a transformational impact on all aspects of the clinical research enterprise. An improved architecture that places the patient at the center and returns information to members of the cohort is a core component of the vision of this initiative. In spite of the extensive investments made in data standards, and improved understanding of the core principles that facilitate intra-operability, many challenges remain. There are not yet agreed upon Core Data Elements for many critical components needed for the Cohort. This project will develop the data policies and technology data standards needed for the PMI National Cohort, including standards for syntax (structure), semantics (common naming and coding practices) and transmission.
OS PCORTF Resource Center
The purpose of this contract is to maximize the impact of the OS PCORTF by providing services to PCORTF awardees to enhance implementation and collaboration, supporting execution against the OS PCORTF strategic framework, and furnishing logistical support through 2019. Resource center functions will include portfolio assessment support, technical support for project development and implementation, communication and dissemination support, and assistance with portfolio management tasks.
Utilizing data from various data partners in a distributed manner
This project would develop the capability to conduct rapid and secure distributed regression analysis that enables 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 aggregate interim data, transfer sensitive information, or conduct meta-analysis. The deliverable from this project would be open source software that allows stakeholders to perform automated distributed regression within actual PCOR distributed data networks.
Improving the mortality data infrastructure for patient-centered outcomes research
The National Center for Health Statistics (NCHS) proposes to improve mortality data infrastructure through more timely delivery of state death records (i.e., fact of death and cause of death) to the National Death Index (NDI) database, and through linkage of NDI records with National Hospital Care Survey data. The deliverables from this project include: 1) an additional 22 states that can report the fact of death to NCHS for at least 80% of the deaths occurring within their states within 5 days of death and within 10 days for cause of death and 2) improved processes for mortality file closing.
Cross-network directory service
This project creates an open source interoperable service to allow: 1) a way for data partners to easily participate in multiple data research networks, 2) a way for queries to seamlessly move across such networks, and 3) a mechanism to share analytic capabilities and knowledge across networks. This project also will pilot test this cross-network directory service across at least two existing networks: FDA’s Mini-Sentinel and PCORI’s PCORnet.
Collection of patient-provided information through a mobile device application for use in comparative effectiveness and drug safety research
This investment will enable patients to transmit data through mobile devices to a secure data repository. Researchers will be able to query both the patient-provided data repository and traditional data providers that belong to the Mini-Sentinel distributed database. Since PCORnet and Mini-Sentinel share the same Coordinating Center, this investment will directly benefit research performed by both organizations. The deliverable from this effort is a generalizable mobile device application to capture data from pregnant women (i.e., drug exposures, outcomes, risk factors and confounders) that will be linked with a large distributed database (i.e., Mini-Sentinel). This effort will serve as a pilot for and collaborate with the effort noted below.
Conceptualizing a data infrastructure for the capture and use of patient-generated health data
Patient-generated health data (PGHD) can be collected today directly from patients using surveys and structured questionnaires in both paper and electronic form, and electronically through devices (e.g., glucometers) and mobile technology. However, PGHD is not sufficiently represented in either records of care or in research. In order to increase the capture and use of PGHD to meet the needs of researchers, patients and providers, this project will develop a policy framework for the use of PGHD in research and care delivery that addresses needed tools, data donation policies, regulatory gaps, use of EHRs for PGHD, and interoperability of PGHD. In addition to the policy framework, project deliverables include the results from pilot tests of the framework.
Security and privacy standards for patient matching, linking and aggregation
This project will standardize patient attributes and algorithms for use in reliably matching patients across organizations. It will also create the privacy and security (P&S) application programming interface (API) specification guides that enable real-time linking and matching of patients with associated research, claims and clinical data. Deliverables include: an environmental scan, standards and a specifications/implementation guide for the patient attributes, matching algorithms and the P&S API specification.
PCOR: Privacy and security blueprint, legal analysis and ethics framework for data use, & use of technology for privacy
Patient-level data are essential to understanding and improving health outcomes. These data must be made available to researchers in a way that ensures the protection of patient privacy while providing sufficient granularity to allow meaningful conclusions to be drawn. Yet, current laws and policies around use of patient-level data are nuanced and sometimes conflicting, creating confusion for researchers, providers and patients. Frameworks are needed to address the many legal and privacy and security-related policy issues that affect use of this data for research. This project will develop these frameworks and also identify, refine, harmonize, validate, recommend, and pilot standards that support an individual’s consent and preferences for research.
OS PCORTF evaluation
This project will create the foundation for evaluation of the effectiveness of OS PCORTF data infrastructure investments. The initial phase of this project will determine an evaluation framework and specific ways to measure portfolio success.
Data infrastructure sustainability
A national data infrastructure, once enabled, will need to be maintained and enhanced beyond the life of the current PCORTF in order to remain viable. This project will undertake a comprehensive feasibility study to recommend options for business model and organization design pathways that result in a sustainable national data infrastructure for patient-centered outcomes research. Options for policy makers will also be outlined based on the findings.