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About the Project

Purpose of XeDermaRegistry

a  “Xe-Derma Registry” is an organized system that uses observational study methods to collect uniform data to evaluate specified outcomes for a burns surgery patients with Xe-Derma. 

Patient registry can provide a real-world view of clinical practice, patient outcomes, safety, and effectiveness and serve a number of evidence development and decision making purposes .

Patient registries and randomized controlled trials (RCTs) have important and complementary roles in evaluating patient outcomes.  Patient registries collect data in a comprehensive manner (with few excluded patients) and therefore produce outcome results that may be generalizable to a wide range of patients.  They also evaluate care as it is actually provided, because care is not assigned, determined, or even recommended by a protocol. As a result, the outcomes reported may be more representative of what is achieved in real-world practice.

For a clinician, registry can collect data about cataract surgical treatment outcomes on large numbers of patients rapidly, thereby producing a real-world  picture of tretment.

For a medical device manufacturer, a registry might demonstrate the performance and safety of a product in the real world, meet a postmarketing study commitment, develop hypotheses, which will be useful for product development or new clinical trials design. 

 

1.        Frequently Asked Questions about Medical and Public Health Registries. The National Committee on Vital and Health Statistics. http://ncvhs.hhs.gov/9701138b.htm.  Accessed January 17, 2007.
2.        Labresh KA,  Gliklich R,  Liljestrand J et al. Using “Get With The Guidelines” improve cardiovascular secondary prevention.  Jt Comm J Qual Patient Safety  2003 Oct;29(10): 539-50.
3.        Kennedy L, Craig AM. Global registries for measuring pharmacoeconomic and quality-of-life outcomes: focus on design and data collection, analysis and interpretation. Pharmacoeconomics 2004;22(9):551-68.
4.        U.S. Food and Drug Administration. FDA Guidance for Industry.  Good pharmacovigilance and pharmacoepidemiologic assessment. March 2005.