Loading presentation...

Present Remotely

Send the link below via email or IM

Copy

Present to your audience

Start remote presentation

  • Invited audience members will follow you as you navigate and present
  • People invited to a presentation do not need a Prezi account
  • This link expires 10 minutes after you close the presentation
  • A maximum of 30 users can follow your presentation
  • Learn more about this feature in our knowledge base article

Do you really want to delete this prezi?

Neither you, nor the coeditors you shared it with will be able to recover it again.

DeleteCancel

Make your likes visible on Facebook?

Connect your Facebook account to Prezi and let your likes appear on your timeline.
You can change this under Settings & Account at any time.

No, thanks

Fidaxomicin vs Vancomycin

RCT Trials
by

Azizur Choudhury

on 24 May 2015

Comments (0)

Please log in to add your comment.

Report abuse

Transcript of Fidaxomicin vs Vancomycin

eaning
rial Evaluation
urther Evaluation
ummary
cenario

Was the study valid?
recognise the type of study
understand the meaning of validity
use a simple criteria to evaluate study
Aims
Objectives
hat makes a Trial Valid
Validity
Questions?
FIDAXOMICIN VS VANCOMYCIN
FOR CLOSTRIDIUM DIFFICILE INFECTION
What are your reasons for reaching this conclusion?
ype of study
Clinical trial comparing the efficacy and safety of fidaxomicin with those of vancomycin in treating clostridium difficile.
Definition of Validity
The extent to which a measurement, test or study measures what it purports to measure.
Well grounded; just
Randomised
Double-Blind
Clinical Trial
Phase 3
Did the trial address a clearly focused research question?
Did the authors use the right kind of study?
Screening Questions
Was the assignment of patients to treatments randomised?
Were all the patients entered in the trial properly accounted for at its conclusion?
Were patients, health workers and study personnel "blind" to treatment?
Were the groups similar at the start of the study?
Aside from the experimental intervention were the groups treated equally?
Did the trial address a clearly focused research question?
Yes
-two drugs compared for efficacy and safety for one condition, with clearly defined end points - cure and recurrence.
Did the authors use the right kind of study?
Was the assignment of patients to treatments randomised?
Were all the patients entered in the trial properly accounted for at its conclusion?
Were patients, health workers and study personnel "blind" to treatment?
Were the groups similar at the start of the study?
Aside from the experimental intervention were the groups treated equally?
Yes
Yes
Yes
Yes
Yes
Yes
- randomised control trial always best form of trial
- an interactive voice-response system and computer generated randomisation schedule were used to provide provide a randomisation number and medication kit number for each patient.
- accounted for everyone, including reasons dropped out and reasons not included in per-protocol analysis.
- double-blind trial.
- all capsules over encapsulated to look identical and two placebo doses given with fidaxomicin so that there were identical dosage regimens.
- as shown in table 1 (page 427) demographic and baseline clinical characteristics of the patients were similar.
- treated equally with the same follow up times, as blinded both ways.
Other considerations
Dropout Rate
Impact Factor
Jadad Score
Concerns
5.2%
- indicates good validity as anything less than 20% dropoutrate is considered valid
51.658
-the journal in which the article is published can reflect the validity and reliability as journals are given impact scores based on citations. NEJM has a very good score.
Was the study described as randomised?
No
Yes
Was the method of randomisation described in the paper and was it appropriate?
Was there a description of withdrawals and dropouts?
Was the study described as double blind?
Was the method of blinding described, and was it appropriate?
Three or more yeses to the following five questions is a good score.
- this trial has a very good score of 5 out of 5
Size of trial
- only 629 patients small for phase 3 clinical trial.
Author of study
- works part time for Optimer Pharmaceuticals who sponsored the study and also make fidaxomicin, could this cause bias.
In conclusion study is......
the study met all our screening criteria
low dropout rate
published in reputable journal
has very good Jadad score
Summary
Age
- patients were generally over the age of 50
VALID
Full transcript