Linked Life Data

17219753

Source:http://linkedlifedata.com/resource/pubmed/id/17219753

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2007-1-15
pubmed:abstractText
Propensity score analysis is a versatile statistical method used mainly in observational studies for improving treatment comparison by adjusting for up to a relatively large number of potentially confounding covariates. Recently, there has been an increased interest in applying this method to nonrandomized medical device clinical studies. In the application of the methodology, some statistical and regulatory issues arise in both study design and analysis of study results, such as the need for pre-specifying clinically relevant covariates to be measured, appropriate patient populations, and the essential elements of statistical analysis, planning sample size in the context of propensity score methodology, handling missing covariates in generating propensity scores, and assessing the success of the propensity score method by evaluating treatment group overlap in terms of the distributions of propensity scores. In this paper, the advantages and limitations of this methodology will be revisited, and the above issues will be discussed and illustrated with examples from a regulatory perspective.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1054-3406
pubmed:author
pubmed:issnType
Print
pubmed:volume
17
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1-13; discussion 15-7, 19-21, 23-7 passim
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2007
pubmed:articleTitle
Statistical and regulatory issues with the application of propensity score analysis to nonrandomized medical device clinical studies.
pubmed:affiliation
CDRH, U.S. Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, USA. lilly.yue@fda.hhs.gov
pubmed:publicationType
Journal Article