A framework for creating standardized outcome measures for patient registries.

AIM: Our objectives were to create a conceptual framework for development of standard outcome measures and to design and pilot test a tool for displaying outcome measures. MATERIALS & METHODS: Information on outcome measures used in registries was gathered through stakeholder discussions, which informed the development of the outcome measurement framework and the related tool. RESULTS: The outcome measurement framework is a conceptual model for how information relevant to evaluating patient outcomes may be defined and collected in a standard way for a broad range of health areas. The related tool facilitates collecting, displaying and searching for information on outcome measures. CONCLUSION: The model developed through this process offers a framework that can be used to define outcome measures in a standard way across medical conditions.

The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program.

The US Food and Drug Administration's Mini-Sentinel pilot program is developing an organizational structure as well as principles and policies to govern its operations. These will inform the structure and function of the eventual Sentinel System. Mini-Sentinel is a collaboration that includes 25 participating institutions. We describe the program's current organizational structure and its major principles and policies. The organization includes a coordinating center with program leadership provided by a principal investigator; a planning board and subcommittees; an operations center; and data, methods, and protocol cores. Ad hoc workgroups are created as needed. A privacy panel advises about protection of individual health information. Principles and policies are intended to ensure that Mini-Sentinel conforms to the principles of fair information practices, protects the privacy of individual health information, maintains the security and integrity of data, assures the confidentiality of proprietary information, provides accurate and timely communications, prevents or manages conflicts of interest, and preserves respect for intellectual property rights.