美国AHRQ《评估患者结局的注册登记指南(第2版)》解读(5)
How to read and understand Registries for Evaluating
Patient Outcomes： A User′s Guide (2nd Edition)
YANG Wei， XIE Yan-ming*
(Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China)
[Abstract] Registry studies (RS) get more and more attention in recent years because it can reflect the health care situations of the real world. There are a number of large scale RS for traditional Chinese medicine (TCM). RS are observational studies that can complement randomized controlled trials (RCT). RS have an irreplaceable position in real word study ( RWS)， especially for small probability events. There are some different characters and qualities in RS. Registries for Evaluating Patient Outcomes： A User′s Guide (2nd Edition) was published by the agency for healthcare research and quality (AHRQ) in 2010. It described the details of how to establish， maintain， and evaluate RS， and using 38 RS samples to illustrate the possible problems in undertaking such research. The User′s Guide(2nd Edition)provides a a reliable reference document for RS. TCM injections post-marketing safety surveillance RS is a national program involving multiple centers in China. This program can further improve RS quality their application in China and is a good illustration of how to follow this guide accurately.
[Key words] user′s guide； registry study； guideline comprehension； outcome research； real word clinical research
doi：10.4268/cjcmm20131808, http://www.100md.com(杨薇 谢雁鸣)
Patient Outcomes： A User′s Guide (2nd Edition)
YANG Wei， XIE Yan-ming*
(Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China)
[Abstract] Registry studies (RS) get more and more attention in recent years because it can reflect the health care situations of the real world. There are a number of large scale RS for traditional Chinese medicine (TCM). RS are observational studies that can complement randomized controlled trials (RCT). RS have an irreplaceable position in real word study ( RWS)， especially for small probability events. There are some different characters and qualities in RS. Registries for Evaluating Patient Outcomes： A User′s Guide (2nd Edition) was published by the agency for healthcare research and quality (AHRQ) in 2010. It described the details of how to establish， maintain， and evaluate RS， and using 38 RS samples to illustrate the possible problems in undertaking such research. The User′s Guide(2nd Edition)provides a a reliable reference document for RS. TCM injections post-marketing safety surveillance RS is a national program involving multiple centers in China. This program can further improve RS quality their application in China and is a good illustration of how to follow this guide accurately.
[Key words] user′s guide； registry study； guideline comprehension； outcome research； real word clinical research
doi：10.4268/cjcmm20131808, http://www.100md.com(杨薇 谢雁鸣)