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GRADEexample application of
Jan Brożek< [email protected] >
My potential conflicts of interest
• GRADE working group• Cochrane Collaboration
problem
Q: what to do about it
gather evidence
what evidence says
how believable is evidence
summarise it
balance good & bad
individual preferences
A: recommendation
problem
evidence
solution
Outlin
e
problem
• What are the phenomena associated with the problem?
• What is frequency of the problem?• What causes the problem?
(aetiology)• Does this person have the problem?
(diagnosis)• What if one gets the problem?
(prognosis)• What can we do about the problem?
(treatment)• … etc.
Questio
ns
Should oral oseltamivir be used for treatment of avian influenza (H5N1) in healthy individuals?
Questio
n
avian flu A (H5N1) patients
oseltamivir
no antiviral
mortality
hospitalization
adverse effects
antimicrobial resistance
resource use
Questio
nP:
I:
C:
O:
evidence
systematic review
cannot DO systematic review
use EXISTING
there is NO existing
do PRAGMATIC search
how believable is evidence
• limitations• inconsistency• indirectness• imprecision• publication bias
• large effect• dose-response• „antagonistic bias”
what is the evidence
• no RCT of oseltamivir for H5N1• 5 RCTs in seasonal influenza – hospitalization: OR 0.22 (0.02–2.16)– pneumonia: OR 0.15 (0.03–0.69)
Evid
ence
solution
• no RCT of oseltamivir for H5N1• 5 RCTs in seasonal influenza – hospitalization: OR 0.22 (0.02–2.16)– pneumonia: OR 0.15 (0.03–0.69)
• 3 published case series• many in vitro and animal studies • no alternative more promising• Cost: ~ €40 per course
Evid
ence
• quality of existing evidence
• balance of desirable and undesirable effects
• values and preferences
• cost (resource utilization)
Strength
Because I like it better that way!
Oseltamivir for Avian Flu
Recommendation In patients with confirmed or strongly suspected infection with avian influenza A (H5N1) virus, clinicians should administer oseltamivir as soon as possible (? recommendation | very low quality evidence)
Schunemann et al. The Lancet ID, 2007
strong ? weak
Oseltamivir for Avian Flu
Recommendation In patients with confirmed or strongly suspected infection with avian influenza A (H5N1) virus, clinicians should administer oseltamivir as soon as possible (strong recommendation | very low quality evidence)
Values and PreferencesThis recommendation places a high value on the prevention of death in an illness with a high case fatality. It places relatively low values on adverse reactions, the development of resistance and costs of treatment.
Schunemann et al. The Lancet ID, 2007
Oseltamivir for Avian Flu
RemarksDespite the lack of controlled treatment data for H5N1, this is a strong recommendation, in part, because there is a lack of known effective alternative pharmacological interventions at this time.
The panel voted on whether this recommendation should be strong or weak and there was one abstention and one dissenting vote.
Schunemann et al. The Lancet ID, 2007
quality of evidence
strength of recommendation
questions
Jan Brożek<[email protected]>