Background on Patient Registries continued…

Registries typically involve a more diverse group of patients than clinical trials and spotlight what happens in actual medical practice, which may better reflect real-world management practices and outcomes than randomized controlled clinical trials. Moreover, patient registry information can also be used to build on clinical trial data. For instance, if a preliminary cost-effectiveness model has already been developed, then registry data can be used to update the model to provide a more realistic picture of a product’s value. This will be an increasingly critical activity as payors, pricing authorities, guideline developers, and agencies involved in technology appraisal reassess a product’s cost-effectiveness in the years following its introduction.
Much of a patient registry’s intrinsic value lies in its ability to address, in one comprehensive program, a variety of organizational objectives, crossing disciplines, to provide important disease and product-specific data, and support a product in the marketplace throughout its life cycle. Registries allow collection of post-approval safety information and clinical effectiveness data, and they represent an opportunity to prospectively collect and report on important outcomes, such as health-related quality of life (HRQoL), health care resource utilization, and patient satisfaction. Data from registries may also be used to support other health economics/outcomes research (HE/OR) initiatives, such as cost-of-illness studies, economic modeling, cost effectiveness analyses, and capture endpoints such as long-term outcomes and patient utilities.
Patient registries are used extensively by the outcomes research community, government health care regulators, and the pharmaceutical, biotechnology, and medical device industries for risk assessment, evaluation of risk management interventions, and to address post-approval regulatory requirements (e.g., safety surveillance). Registries are also important pre-approval in providing better information on natural history of disease and the costs of care.
Most recently, the Agency for Healthcare Research & Quality (AHRQ)
(http://effectivehealthcare.ahrq.gov/ ) published Registries for Evaluating Patient Outcomes: A User's Guide in May 2007, AHRQ Publication Number 07-EHC001-1.
http://effectivehealthcare.ahrq.gov/reports/topic.cfm?topic=0&sid=2&rType=11&sType=3

The User’s Guide is the result of a study of registries and the many elements involved in creating a registry.  The collaborators (Effective Health Care Program, Outcome Sciences, Inc., a DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) center, and the Duke EPC (Evidence-based Practice Center) developed a handbook to serve as a guide to the design, implementation, analysis, interpretation, and evaluation of the quality of a registry for understanding patient outcomes.

To enhance and support the development of good research practices for patient registries, ISPOR initiated three working groups to address issues raised by the AHRQ project and other related registry issues.

Patient Registries Special Interest Group