The PSDM group of the Biometrics Section (BMS) of the Netherlands Society for Statistics and Operations Research (VVS/OR) cordially invites you for the PSDM event
Statistical and Practical Issues of
Patient Reported Outcomes (PROs)
(including annual PSDM meeting)
On Thursday November 25, 2010
| 12.30 | Registration and coffee |
| 12.55 | Welcome Wouter Wijker (PSDM board member) |
| 13.00 | Introduction and overview of PROs Dr Pythia Nieuwkerk – AMC |
| 13.45 | ePro evaluation and emerging best practice Adam Wood, Account Director, invivodata Abstract Title: ePRO Evolution and Emerging Best Practice
Description: Electronically collected Patient Reported Outcomes (ePRO) data has become an important method used in clinical trials. While the players in the ePRO arena have changed through the years, the technology and science have matured, resulting in compelling arguments for capturing PRO data electronically. And, with evidence that screen-based ePRO measures are equivalent to their paper predecessors, regulatory bodies such as the U.S. Food and Drug Administration (FDA) have made great strides in guiding the clinical research community on the appropriate use of ePRO. So, it’s no surprise that ePRO is rapidly replacing paper-based PRO.
This presentation will focus on the changes in ePRO that are most relevant to clinical researchers, including the evolution of modern ePRO, the role of psychometric and linguistic validation, and how regulatory bodies, such as the U.S. FDA are impacting clinical data management, through its Final Guidance on PROs.
Presenter: Adam Wood, Account Director, invivodata
Contact Details: awood@invivodata.com, +44 78 5492 8430
|
| 14.30 | Coffee/Tea break |
| 15.00 | A taxonomy of test construction methods and validity procedures (talk in Dutch language) Dr Harrie Vorst, University of Amsterdam A taxonomy of test construction methods and validity procedures
In this presentation a taxonomy of six test construction methods will be discussed and a general outline of validity procedures. The six construction methods are aimed at different qualities of tests: respectively, face validity, process validity, homogenity, criterion validity, construct validity, content validity. Each method consists of seven construction steps. Psychometric issues will be discussed: measurement model, measurement invariance, reliability, validity, prediction and utility. An example of the measurement of intelligence by questionnaire will be used to illustrate the issues.H.C.M. Vorst University of Amsterdam Department of Psychology;
Research Group Psychological Methodology |
| 15.45 | Item Response models for the analyses of questionnaire data Prof. Paul de Boeck, University of Amsterdam |
| 16.30 | Annual PSDM Meeting Huishoudelijke vergadering PSDM meeting 25 Novemer 2010 te OSS _MSD_ |
| 17:00 | Closure and drinks |
hosted by MSD, Molenstraat 110, Oss, the Netherlands. Tel. 0412 66 12 22.
Price: 50 Euro
Upon registration you will receive an invoice ad 50 euro by regular mail.
Please note that for participants it is also possible to pay cash upon arrival on the day of the workshop.
Registrations are transferable to another individual after notification to the organisers.
Cancellation is possible up to 24h before start of the meeting.
Pharmaceutical Statistics and Data Management 