Significant variation exists in both the types and definitions of outcome measures used in patient registries, even within the same clinical area. This variation reduces the utility of registries, making it difficult to compare, link, and aggregate data across the spectrum of clinical care and reporting. 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.1
AHRQ is assessing the feasibility of using the OMF to develop standardized libraries of outcome measures in five clinical areas, including (1) Atrial fibrillation, (2) Asthma, (3) Depression, (4) Lung cancer, and (5) Lumbar spondylolisthesis.2 These clinical areas represent diverse populations and care settings, different treatment modalities, and varying levels of harmonization. For each clinical area, the relevant registries and observational studies are identified, and registry sponsors, informaticists, and clinical subject matter experts are invited to participate in a registry group that focuses on harmonizing outcome measures through a series of in-person and web-based meetings. A stakeholder group, including payers, patient representatives, Federal partners and health system leaders, is also assembled to discuss challenges and provide feedback on the harmonization effort.
A key goal of this effort is to standardize the definitions of the components that make up the outcome measures, so users can understand the level of comparability between measures across different systems and studies. As a final step in the harmonization process, clinical informaticists map the narrative definitions (generated by the workgroups) to standardized terminologies to produce a library of common data definitions.
This document describes the technical approach used to prepare the Standardized Library of Lung Cancer Outcome Measures workbook. For reference, the narrative definitions for the minimum set of outcome measures produced by the Lung Cancer Workgroup are included in Appendix A.
1Gliklich RE, Leavy MB, Karl J, et al. A framework for creating standardized outcome measures for patient registries. Journal of Comparative Effectiveness Research. 2014;3(5):473-80.
2This work was supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement #16-566R-16.
Edelman MJ, Raymond DP, Owen DH, et al. Harmonized Outcome Measures for Use in Non-Small-Cell Lung Cancer Patient Registries and Clinical Practice. J Natl Compr Canc Netw. 13 Aug 2021. [Epub ahead of print.] DOI: 10.6004/jnccn.2021.7021.
Gliklich RE, Leavy MB, Li F. Standardized Library of Lung Cancer Outcome Measures. Research White Paper. (Prepared by L&M Policy Research, LLC under Contract No. 290-2014-00004-C.) AHRQ Publication No. 19(21)-EHC007-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2021. Posted final reports are located on the Effective Health Care Program search page. DOI: 10.23970/AHRQEPCLIBRARYLUNGCANCER