Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation, makes it difficult to compare, link, and aggregate data across a range of registries reflective of the spectrum of clinical care and reporting, thus reducing the potential utility of registry data. To address these limitations, the Agency for Healthcare Research and Quality (AHRQ) developed the Outcome Measures Framework (OMF), a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions; it is intended to serve as a content model for developing harmonized outcome measures for specific clinical areas.

This report describes the process developed and used by the project team to assess the overall feasibility of using the OMF to develop standardized libraries of outcome measures, including the selection of clinical areas, recruitment of the registry and stakeholder workgroups, methodology for harmonizing outcome measures, and approach to creating standardized data definitions. The report also discusses the results from each clinical workgroup, as well as the lessons learned from each phase of the project. The final section of the report includes recommendations for future work to expand beyond the feasibility-testing stage.

Contents

• Preface
• Executive Summary
  • Challenges and Lessons Learned
  • Next Steps
• Introduction
  • Project Overview
  • Background and Rationale
• Key Project Activities
  • Selection of Clinical Areas
  • Considerations for Selection
  • Compiling Information on Potential Clinical Areas
  • Identifying Registries Within Clinical Areas
  • Engaging Registries and Other Stakeholders
  • Convening Registry and Stakeholder Workgroups
  • Identification and Categorization of Outcome Measures
  • Collection of Outcome Measures
  • Comparison of Outcome Measures Across Sources
  • Refining Minimum Measure Sets and Harmonization
  • Defining Participant, Provider, and Disease Characteristics
  • Defining Treatments
  • Data Element Development: Measure Definitions and Data Element Descriptions
  • Development of Standardized Terminologies
  • Leveraging Existing Resources
  • Public Comment
• Challenges and Lessons Learned
• Next Steps
  • Implementation
  • Dissemination
  • Ongoing Governance
  • Additional Clinical Areas
• References
• Abbreviations
• Appendixes
  • Appendix A. Proposed Clinical Areas
  • Appendix B. Registry and Stakeholder Participants

Suggested citation:

Leavy MB, Schur C, Kassamali FQ, Johnson ME, Sabharwal R, Wallace P, Gliklich RE. Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned. Final Report. (Prepared by L&M Policy Research, LLC under Contract No. 290-2014-00004-C) AHRQ Publication No. 19-EHC008-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2019. Posted final reports are located on the Effective Health Care Program search page. DOI: https://doi.org/10.23970/AHRQEPCLIBRARYFINALREPORT.

This report is based on research conducted by the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Centers’ Methods Workgroup. This work was supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement #16-566R-16. The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help EPCs and AHRQ understand health-systems need and use of evidence to inform their decision making. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the authors and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

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