Harmonization of Clinical Data Element Definitions for Outcome Measures in Registries

STATUS: Completed Project

BACKGROUND

Electronic health records (EHRs) and registries contain a variety of rich clinical information including demographics, diagnoses, medications, allergies, and laboratory values. These data have the potential to support hypothesis generation and large scale clinical research studies. However, it is essential to address the variability in clinical definitions in order to meaningfully interpret results of studies and use the results to improve patient outcomes.

To address this need, the Agency for Healthcare Research and Quality (AHRQ) developed an Outcomes Measures Framework (OMF) – a conceptual model classifying outcome measures across condition areas that could be used to develop standardized outcome measures for use in research and clinical practice. This PCORTF project used the OMF to create standardized outcome measures for five clinical areas.

PROJECT PURPOSE & GOALS

This project convened a series of clinical topic specific working groups to discuss the various clinical outcome definitions currently in use and how these definitions could be harmonized to promote common definitions across data collection and reporting systems. The working groups solicited input from a broad stakeholder community, including registry holders, EHR developers, policymakers developing quality measures, and clinicians, among others.

Project Objectives:

• Develop a consensus set of clinical data element definitions, for outcome measures for each of five wide-ranging clinical topic areas, to be used in registries.

• Develop best practices for governance of data element definition libraries.

• Develop best practices for harmonization of outcome measures between different registries, EHRs, and reporting requirements.

PROJECT ACHIEVEMENTS & HIGHLIGHTS

• The project team used the OMF to develop standardized libraries of outcome measures in five clinical areas: 1) atrial fibrillation; 2) asthma; 3) depression; 4) non-small cell lung cancer, and 5) lumbar spondylolisthesis. These libraries contain the clinical definitions of the outcome measures and the value sets.

• In addition to the clinical workgroups advising the project, the team assembled a stakeholder group composed of patient and provider representatives and Federal partners for each clinical area, to discuss challenges and provide feedback on the harmonization effort.

• As a final step in the harmonization process, the team mapped the narrative definitions, generated by the workgroups, to standardized terminologies in order to produce a library of common data definitions that can be implemented in EHRs to facilitate standardized outcome data collection.

• The project team produced a final report, which describes: 1) the process developed and used by the team to assess the overall feasibility of using OMF to develop standardized libraries of outcomes measures; and 2) lessons learned from each phase of the project and recommendations for future work.

PUBLICATIONS, PRESENTATIONS, AND OTHER PUBLICALLY AVAILABLE RESOURCES

Resources:

• AHRQ published its final report, “Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned,” in February 2019. The report is available here: https://aspe.hhs.gov/sites/default/files/private/pdf/259016/HP-16-007-FinalReport.pdf

• AHRQ publicly posts each clinical definition in a library on their website for peer review. These libraries are available here: https://effectivehealthcare.ahrq.gov/topics/registry-of-patientregistries/outcome-measures-framework.

Publications:

• AHRQ published a journal article in January 2019 titled “Harmonized Outcome Measures for Use in Atrial Fibrillation Patient Registries and Clinical Practice” in Heart Rhythm. The article was endorsed by the Heart Rhythm Society Board of Trustees and can be found here: https://www.heartrhythmjournal.com/article/S1547-5271(18)30948-2/fulltext

• AHRQ published a journal article in September 2019 in the Journal of Allergy and Clinical Immunology titled, “Harmonized Outcome Measures for Use in Asthma Patient Registries and Clinical Practice. The article can be found here: https://www.jacionline.org/article/S0091-6749(19)30342-2/abstract.

• AHRQ published a journal article in Annals of Internal Medicine in May 2020 titled “Harmonized Outcome Measures for Use in Depression Patient Registries and Clinical Practice” in June 2020. The article can be found here: https://www.acpjournals.org/doi/10.7326/M19-3818. There is also an editorial: “Using a standardized approach to measuring outcomes in both clinical and research settings has the promise to significantly improve the quality of depression care. Researchers, clinicians, and health systems should adopt these measures as soon as possible.” https://www.acpjournals.org/doi/10.7326/M20-1993.

Presentations:

• AHRQ has presented this project in over 10 different panels including but not limited at the American Medical Informatics Association® (AMIA), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Medicaid Medical Director’s meeting, and AcademyHealth’s Health Datapalooza. AHRQ also presented a webinar on “Development of Harmonized Outcome Measures for Use in Research and Clinical Practice” as part of the NIH Collaboratory Grand Rounds series in April 2019 (available at https://rethinkingclinicaltrials.org/news/april-12-2019-development-of-harmonized-outcome-measures-for-use-in-research-and-clinical-practice-richard-gliklich-md-michelle-leavy-mph-elise-berliner-phd/).

RELATED PROJECTS

Below is a list of ASPE-funded PCORTF projects that are related to this project

Development of Data Infrastructure for Use of EHRs in Comparative Effectiveness Research (ONC/NLM CDEs) - The ONC and NLM common data elements (CDE) project was developed to standardize the collection and exchange of data, i.e., CDEs. For the electronic Case Report Forms (eCRFS), the project developed the standards for the eCRF structure/template as well as the CDEs that were used with them. These forms were ‘extensible forms’ which means that they were developed in a high-level computer language. This computer language facilitates defining the form as a single, stand-alone object. Taken together, these two ONC/NLM CDE products make evident that the project fits the functionality of Standardized Collection of Standardized Data.

Capstone for Outcomes Measures Harmonization Project - The AHRQ Capstone project objective is to improve the collection and use of outcomes measures by linking clinical data to two different registries, and pilot-testing the bi-directional exchange of data between the registries and clinical sites. This project expands data capacity for patient-centered outcomes research by: collecting electronic health data from multiple clinical sites on patient outcomes associated with treatment for depression; transferring the collected data to electronic patient registries for research; and developing infrastructure and tools to allow replication.

Developing a Strategically Coordinated Registry Network (CRN) for Women’s Health Technology - The Food and Drug Administration, together with the Office of the National Coordinator (ONC) and the National Institutes of Health/National Library of Medicine establish a CRN for research on Women’s Health Technologies by developing a community of stakeholders interested in working together to make system changes in an area of women’s health device safety and effectiveness. This project develop tools to facilitate collection of data within registries, improve the value and sustainability of registries through leveraging electronic data, and demonstrating that the data in the registries can be reused to answer additional questions through the addition of new data elements and patient cohorts.