State of the science/evidence base for integrative modalities
Secondary Topic: Curriculum design and development
Non-randomized Pragmatic Controlled Trials (PCTs) Supplement Randomized Controlled Trails (RCTs) in Comparative Effectiveness Research
Franz Porzsolt, MD, PhD, Institute of Clinical Economics (ICE) e.V., Ulm, Germany; Christel Weiss, PhD, Medical Statistics, Campus Mannheim, Univ Heidelberg & ICE e.V. Ulm/Germany, Mannheim / Heidelberg , Germany
Late Breaker: No
Archie Cochrane asked three essential questions: "Can it work?", "Does it work?", and "Is it worth it?". The purpose of my presentation is to show that the first question requires a efficacy trial (research under ideal study conditions), while the second and third questions require a effectiveness trial (research under real world conditions).
The objective will be to elucidate the difference between efficacy and effectiveness trial.
The general principle can be explained in 20 minutes
The discussion of the detailed differences of PCTs and RCTs requires about 45 miniutes
It also may be interseting to invite experts to participate a 3-part-consensus conference. 90 minutes
- In the first part the participants decscribe the potential bias that have to be prevented in a RCT.
- In the second part the partiopants offer solutions to prevent theses forms of bias.
- In the third part the participants select the best items from the proposals and summarize it in a consensus paper.
Prof. Dr. Franz Porzsolt
Depending on type of presentation;
a) lecture 20 min
b) seminar 45 min
c) moderated interactive development 90 min
There are significant differences between RCTs and PCTs. The following are unique to PCTs (compared to RCTs), and I woud discuss them further in my presentation;
If the program committee feels your presentation would be better suited for a different presentation type, such as a symposium (shorter format during the main meeting), would you be willing to adapt your presentation to fit the new format?Yes
Who is the target audience of the workshop? Are there particular skills or background that are recommended as pre-requests?Anyone who is interested in comparative effectivness research. The more detailed the teaching offer is the more should the participants know about clinical trials.
Is this workshop proposed by an organization?Yes
If yes, please nameInstitute of Clinical Economics (ICE) e.V.
Has the content (or substantial parts) of this workshop been previously presented or published (note: previous experience presenting the material may be considered a strength as long as continued interest is anticipated)?Yes
Please provide Location of Presentation and/or Publication Information and date of each presentation