NHS CEVEAS INFORMATION PACKAGES
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NHS CeVEAS Information Packages
Nicola Magrini
CeVEAS - Centro per la Valutazione della Efficacia
dell’Assistenza Sanitaria
WHO Collaborating Centre for Evidence Based Research Synthesis
and Guideline Development in Reproductive Health
Bologna 24 Settembre 2010
What I’ll talk about
Drug Information:
what is essential?
Nicola Magrini
CeVEAS - Centro per la Valutazione della Efficacia
dell’Assistenza Sanitaria
WHO Collaborating Centre for Evidence Based Research Synthesis
and Guideline Development in Reproductive Health
Bologna 24 Settembre 2010
Contenuti della presentazione • A foreword: what is essential? … or when less is more … • Information pacakges and new formats … • Conclusioni
Essenziale … l’opposto di lungo? … since I didn’t have much time, I wrote it long … Richard Smith, BMJ editorial board meeting (2003-2004)
From BMJ: clear, essential and in context What we knew before After we have read this study
Interpretare le evidenze
Statistica e interpretazione dei risultati:
non scambiare i mezzi coi fini …
Bradford Hill.
Textbook of medical statistics
From clinical trials to clinical practice:
three or four essential questions
Ø Are the results valid? Are they relevant?
Ø Are they applicable to my decisions/patients?
Ø Should I change my behaviour? [What do we know
from other available studies? Do I suspect a strong
publication bias? What are the other available options?]
Emilio Maestri, 2000BMJ, 28 August 2010
• When judging research, we were taught to ask
three questions on behalf of the reader:
• Do I understand it, do I believe it, do I care?
• … no article was allowed to end with the
redundant claim that more research is needed
Fiona GodleeThe importance of publication bias Its relevance is growing …
NEJM 12 November 2009
Changing the outcomes … is convenient
Changing outcomes means improving (falsifying) study results • Reporting biases such as those we describe here increase the likelihood that interventions will appear to be effective when they are not. • Such biases can lead to the omission of negative findings in systematic reviews of intervention effectiveness and in evidence-based guidelines. • For example, the 2005 Cochrane systematic review regarding the effectiveness of gabapentin for acute and chronic pain concluded that it is effective on the basis of published findings and should now be updated with the inclusion of unpublished information made available through litigation.
Contenuti della presentazione • A foreword: what is essential? … or when less is more … • Information packages and new formats … • Conclusioni
Improve format
P of presentation:
extract PICO
I C from abstract
or text
O
THow we tried to improve the format
P
I/C
O
TP I C T O + risultati
P I/C O T
Better use of graphs and
images2 or 3 steps in cancer pain
The importance
of measuring
painImproving formats Comparing studies in absolute terms and using baseline risks … statins
Who is more informative? The New York Times … or scientific journals?
Prescribers should know more
NY Times 18 febbraio 2005
NY Times 18 febbraio 2005 Dr. Christopher Grubb, a captain in the Army Medical Corps, said soldiers in the 82nd Airborne were required to carry a cox- 2 drug in the event of a battlefield injury. Dr . Grubb said the drugs had allowed many soldiers who otherwise would have been sidelined by pain to be deployed overseas. The drugs, he said, ''are essential for our global war on terrorism.'' The comment prompted loud laughter in the meeting.
FDA, votes and Panel decisions • Perhaps most important, many members of the eighteen standing committees of experts that advise the FDA on drug approvals also have financial ties to the industry. • After the painkiller Vioxx was removed from the market in 2005 (it increased the risk of heart attacks), the FDA convened a panel consisting of two of these committees to consider whether painkillers of the same class as Vioxx should also be removed from the market. • Following three days of public hearings, the combined panel decided that, although these drugs—called COX-2 inhibitors—did increase the risk of heart attacks, the benefits outweighed the risks. • It therefore recommended that all three of the drugs, including Vioxx, be permitted to remain on the market, perhaps with strong warnings on the labels.
FDA, votes …
scientific journals and NYT
• A week after the panel’s decision, however, The
New York Times revealed that of the 32 panel
members, ten had financial ties to the
manufacturers, and that if their votes had been
excluded, only one of the drugs would have
been permitted to stay on the market.
• As a result of this embarrassing revelation, the
FDA reversed the panel and left only one of the
drugs, Celebrex, on the market, with a warning
on the label.Contents of the presentation • A foreword: what is essential? … or when less is more … • Information packages and new formats … • Conclusions
A good enough information…
• Be systematic, explicit, able to quantify the
magnitude of expected benefits and harms
• Be simple, clear, atractive … the boredom of a
research paper format …
• Produce information packages or enrichedand
inclusive formats:
– Regulatory agencies documents and decisions
– Explain differences and soundness of guidelines and
role of potential conflicts of interests
– Have a look to what journals say …
– Global evidences and local context …Conclusioni
“To me, “knowledge” is about access
and understanding. Action is then a
choice (hopefully an informed one)
for the individual.”
Chris Silagy, Australia 1999You can also read
