Case Studies

From multi-year task orders with a team of subcontractors to smaller-scale individual research efforts, L&M has led dozens of research projects from government agencies, as well as private clients.

Registry of Patient Registries (RoPR)

Agency for Healthcare Research and Quality (AHRQ) (With partners Academy Health and Truven Health Analytics), April 2014 through April 2019

Objective

Assist the Agency for Healthcare Research and Quality (AHRQ)’s efforts to maintain and promote registration to the RoPR¹ system; establish a web-based interactive forum for discussing topics related to the methodology of registries; implement and refine the Outcome Measures Framework (OMF) for use in the RoPR, and; develop a series of white papers that will be incorporated in the fourth edition of the registry handbook, "Registries for Evaluating Patient Outcomes: A User’s Guide."

Challenges

The need for a system such as RoPR arises from the variation in outcome and quality measures used across studies. These variations can have a substantial impact on study findings and introduce challenges in the aggregation and comparability of results across studies. While the goals of increased collaboration, reduced redundancy, and improved transparency through the RoPR system are widely supported by stakeholders, the team faces a number of logistical and theoretical challenges in refining the OMF informational model and increasing awareness and registration in the RoPR system.

Approach

With the assistance of a Technical Expert Panel (TEP) and key informants, the L&M team continually built on the existing OMF conceptual model to develop an information model that could be easily implemented within the RoPR. First, the team conducted a literature review of existing systems used to standardize language and definitions for outcomes measures and other data elements, including systems for registries, clinical trials, and quality reporting. Based on the literature review, the team then designed an information model that would further develop the outcomes measure framework and inform the development of an Internet-based system that would collect and display information on outcome measures used in patient registries in a standardized way. This system has been termed the Outcome Measures Repository (OMR). Through a qualitative analysis of four condition areas (asthma, depression, rheumatoid arthritis, and cardiac surgery), the team evaluated the level of clinical and analytical detail included in specific measures and determined how outcome measures across different registries can be categorized. The L&M team is also organizing a web-based collaborative registries forum, which will serve as an interactive forum to discuss rapidly evolving areas of registry methodology and best practices. Similarly, the team has engaged in dissemination activities including webinar series, development of manuscripts about the RoPR for peer-reviewed journal submission, and creation of white papers addressing emerging issues in registry science. These papers may be adapted as chapters or may be incorporated into new editions of the User’s Guide, published yearly.

Results

Our Team:

  • Completed a literature review and TEP activities to inform the development and refinement of the OMF. In 2016, the team presented the information model to operationalize the OMR
  • Planned and held six webinars, focusing on the design, development, launch, purpose, and capabilities of the RoPR system
  • Developed ten white papers that will be adapted as chapters or will be incorporated into the Fourth edition of the Registries for Evaluating Patient Outcomes: A User’s Guide handbook (expected publication in 2019)
  • Presented data-harmonization related topics at conferences such as the European League Against Rheumatism (EULAR), the AHRQ Research Meeting, and DIA (Develop, Advance, Innovate)
  • Prepared abstracts and manuscripts for publications in Health Affairs and Bioscience Technology

¹ The Registry of Patient Registries (RoPR), established in 2012, is a database of existing patient registries that was designed with extensive stakeholder participation to promote collaboration, reduce redundancy, and improve transparency in registry-based research. It contains information on existing registries, such as the registry description, classification, and purpose, as well as the registry sponsor’s interest in collaboration opportunities.