Statistics and a little respect …..

Two recent editorials discuss the somewhat unsatisfying results from the RESPECT trial. The study enrolled patients with cryptogenic stroke and a PFO to optimal medical therapy or to PFO closure with the Amplatzer PFO occluder device. Discussion points include patient selection, endpoints, efficacy and P-values.

The RESPECT Trial: What Will the FDA Do?

by Ziyad M. Hijazi, MD, MPH

One of the many shortcomings of comparative observational studies examining patent foramen ovale (PFO) closure versus medical management included in meta-analysis is failure to adjust for potential confounders; therefore, the need for randomized studies is very obvious since they provide the best scientific evidence……..

http://www.invasivecardiology.com/articles/respect-trial-what-will-fda-do

A Respectable Result? Or Do We Need More Closure?

by Steven L. Goldberg, MD

I was reminded of this image of hell when I listened to the results of the RESPECT randomized trial. It is full of some compelling data regarding benefit of PFO closure to prevent recurrent stroke, but because the primary endpoint had a P-value of 0.08, I am anxious that we will not be able to make use of that delicious data……

http://www.invasivecardiology.com/articles/respectable-result-or-do-we-need-more-closure

Advertisements
This entry was posted in Uncategorized. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s