NHS CeVEAS Information Packages

Transcription

1 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

2 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

3 Contenuti della presentazione A foreword: what is essential? or when less is more Information pacakges and new formats Conclusioni

4 Essenziale l opposto di lungo? since I didn t have much time, I wrote it long Richard Smith, BMJ editorial board meeting ( )

5 From BMJ: clear, essential and in context What we knew before After we have read this study

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7 Interpretare le evidenze

8 Statistica e interpretazione dei risultati: non scambiare i mezzi coi fini Bradford Hill. Textbook of medical statistics

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14 From clinical trials to clinical practice: three or four essential questions Are the results valid? Are they relevant? Are they applicable to my decisions/patients? 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, 2000

15 BMJ, 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 Godlee

16 The importance of publication bias Its relevance is growing

17 NEJM 12 November 2009

18 Changing the outcomes is convenient

19 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.

20 Contenuti della presentazione A foreword: what is essential? or when less is more Information packages and new formats Conclusioni

21 P I C Improve format of presentation: extract PICO from abstract or text O T

22 How we tried to improve the format P I/C O T

23 P I C T O + risultati

24 P I/C O T

25 Better use of graphs and images

26 2 or 3 steps in cancer pain

27 The importance of measuring pain

28 Improving formats Comparing studies in absolute terms and using baseline risks statins

29 Who is more informative? The New York Times or scientific journals?

30 Prescribers should know more

31 NY Times 18 febbraio 2005

32 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.

33 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.

34 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.

35 Contents of the presentation A foreword: what is essential? or when less is more Information packages and new formats Conclusions

36 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

37 Conclusioni To me, knowledge is about access and understanding. Action is then a choice (hopefully an informed one) for the individual. Chris Silagy, Australia 1999