Seq #24 Thursday, 26 June 2003

9:00 AM-11:00 AM Svenska Massan G2, Symposium - Group/Division Sponsored
International Multi-center Clinical Research: Issues and Challenges with a Focus on Chronic Pain
* Poster files available online

Sponsored by: Behavioral Sciences, Neuroscience / TMJ
Description: An international consortium for conducting TMD research around the world has been developed with NIDCR support, and the consortium members are now beginning to implement prospective studies of chronic pain conditions. There are many challenges with planning and implementing such studies: multiple sites, human subjects protections, examiner training, examiner reliability across sites, measurement instruments used in diverse cultures and languages, differences in subject recruitment and hence sample size across sites, data coordination and management, multiple protocols affecting different subsets of sites, and incorporation of new instruments and taxonomic standards. Dr. Göran Isacsson (AstraZeneca, Sodertalje, Sweden) will discuss the mechanisms for conducting RCTs for analgesic research across international boundaries, highlighting the roles that institutions and national policies have in different areas around the world. Dr. Alex White (Kaiser Permenente Center for Health Research, Portland, Oregon, USA) will discuss data management, quality assurance methodologies, appropriate computer software for data collection and transmission, development and maintenance of databases, and statistical analyses required for publications, quality control, and patient safety. Dr. Helen Worthington (University of Manchester, Manchester, England, UK) will discuss whether to use weighted or unweighted analyses when comparing data across sites with unequal contributions to the overall study sample. Finally, Dr. Mike John (Martin Luther University Halle-Wittenberg, Halle/Saale, Germany) will discuss reliability assessment in a (TMD) multinational research project with respect to the consequences of measurement error in order to develop useful summary measures. This symposium aims to address some of these methodological and analytical problems that affect TMD research in particular but it will be of broad interest to clinical researchers working with multiple site data in any research domain. This symposium is supported by NIDCR and the International Consortium for RDC/TMD-based Research
Chairperson: R. OHRBACH
 
  9:00 AM Chair's Opening Remarks
0142  9:05 AM Multicenter and international collaboration for randomized trials. Advantages and limitations
G. ISACSSON, AstraZeneca, 151 85 Sodertalje, Sweden
  9:30 AM Multicenter TMD Research: Alternative Approaches to Designs and Methods in International Settings
B.A. WHITE, Kaiser Permanente Center for Health Research, Portland, OR, USA
  9:55 AM Pooling of data from multi-center studies
H. WORTHINGTON, Manchester University, United Kingdom
  10:20 AM Reliability assessment in a (TMD) multinational research project
M.T. JOHN, Martin Luther University Halle-Wittenberg, Halle/Saale, Germany
  10:45 AM Discussion

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