Governance Procedures

As noted above, the Steering Committee will be responsible for strategic and executive decisions regarding the OMR. The Steering Committee will consult with the OMR Staff before making any decisions that will affect the clinical content of the system. The Steering Committee should develop bylaws to specify its decision-making process (e.g., simple majority vote, two-thirds vote). Decisions made by the Steering Committee and the rationale for the decisions should be communicated promptly to the Clinical Advisory Committee and the OMR Staff.

Transparency

Transparency is an important component of a multi-stakeholder system such as the OMF. Information on the governance procedures, as well as the Steering Committee and Clinical Advisory Committee, should be publically available. A clear process will be adopted for developing the agenda and discussion topics for Steering Committee meetings, and meeting minutes should be retained for future reference. A summary of the discussion points and decisions should be publically available. In addition, procedures for selecting members of the Steering Committee and managing existing and new conflicts of interest should be transparent.

Inclusion/Exclusion Criteria

The OMR will include any patient or population outcome measure that is or was developed for used in a patient registry and is submitted to the OMR with all required information. The OMR focuses specifically on outcomes, and not process measures used for quality improvement. Data elements used to evaluate outcomes are to be included in the OMR along with the method for determining the outcomes. Data elements used solely for evaluating processes and/or quality improvement do not represent valid content for the OMR.

To be considered complete, an outcome measure submitted to the OMR must include the complete set of metadata to assure comparisons and complete understanding for users. Metadata requirements are listed in the metadata section. Outcome measures that are published elsewhere (e.g., the National Quality Measures Clearinghouse) may be listed in the OMR. In these cases, the original source of the measure should be cited.

Additional information for an outcome measure may be required when OMR administrators enter content into the system to improve search ability and ease of use. This content is detailed in the OMR Maintenance Guide and includes Conditions, Categories, and Keywords (OMR administrators may add keywords to an item, in addition to the keywords identified by the submitter).

Clinical Equivalency

Some outcome measures submitted to the OMR may be clinically equivalent to other content in the OMR. The OMR must display sufficient metadata definition to allow differentiation or to determine if harmonization is necessary. Definitions that are worded differently but refer to the same concept are considered clinically equivalent definitions. Users seeking to enter clinically equivalent definitions into the OMR should reuse existing definitions, or request collaboration with the current owner (steward) of the existing definition. The OMR should include tools to identify such potential duplicates and to track community-curated harmonization processes. OMR staff should regularly review the outcomes of community curation regarding these potential duplicates and share unresolved disputes with the Clinical Advisory Committee, requesting committee recommendations when harmonization is unsuccessful or exceeds committee-defined time limits.

Review for clinical equivalency should include consideration of the following factors:

• Scope: definitions may differ in scope (e.g., inclusion of existing and acute myocardial infarction versus inclusion of acute myocardial infarction only). Only definitions with the same scope should be considered clinically equivalent.
• Bidirectional equivalency: if one item is a broad definition and a second item describes a subset of that broad definition, the definitions are not equivalent. Clinically equivalent definitions must be equivalent in both directions.
• Supporting evidence: two definitions may refer to the same event, but may require different evidence to make the determination. For example, one definition may rely on findings from a laboratory test, while another is based on a physical examination; such definitions may or may not be clinically equivalent.

When two definitions are determined to be clinically equivalent, the collaborating stewards must designate the dominant, or the harmonized definition. A dominant definition must be designated in two scenarios:

1. Two new items are submitted and reviewed for inclusion in the OMR in the same review cycle. The items are determined to be clinically equivalent. Based on collaboration between the two stewards, one will be added to the OMR as the dominant entry, or a harmonized definition will be substituted. The other definition will not be added. In this scenario, the stewards agree on a compromise definition.
2. A single new item is submitted and reviewed for inclusion in the OMR. The item is determined to be clinically equivalent to an existing item in the OMR. The steward desiring the new item is responsible for collaborating with the steward for the existing item. In cases where the two stewards can agree on one of the existing definitions or a compromised solution (i.e., enhanced definition), the OMR is updated with the resulting definition. In some cases the enhanced specificity of the definition from one steward is sufficiently different than the definition from the other steward; in such cases, both terms and definitions can be included in the OMR. In cases of disputes that cannot be resolved, the Operations Team will review the issue with the Clinical Advisory Committee to recommend a resolution. Any items that are replaced persist in the database but are archived as no longer relevant. Dates for archiving and entry of changes to the OMR may be scheduled to accommodate existing measure programs.