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Mike Clarke speaking at the Symposium on the 10th Anniversary of the German Cochrane Centre

Mike Clarke speaking at the Symposium on the 10th Anniversary of the German Cochrane Centre

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Systematic reviews and randomised trials: influencing public policy Systematic reviews and randomised trials: influencing public policy Presentation Transcript

  • Systematic reviews and randomised trials: influencing public policy 2 April 2008 Professor Mike Clarke UK Cochrane Centre Clinical Trial Service Unit, University of Oxford School of Nursing and Midwifery, Trinity College Dublin
  • Evidence Based Health Care
    • Is not only about systematic reviews of randomised trials of the effects of interventions
    • These provide one component of evidence based health care: an estimate of the effects of treatment
    • However, reliable knowledge of which interventions are beneficial, which are harmful and which have little or no effect is vital to well informed decision making
    • Reliable knowledge comes from reliable evidence , which needs to minimise chance and bias
    • What role should the findings of randomised trials and systematic reviews have in influencing public policy?
    • What role should the conduct of randomised trials and systematic reviews have as part of public policy?
  • Answering these questions with ...
    • Examples of dilemmas faced by public policy
    • Some possible solutions
    • Some real findings
    • Resources that can help
  • Example
  • Sub-arachnoid haemorrhage
    • What is the best way to stop the aneurysm from bleeding again?
  • International Sub-arachnoid haemorrhage trial ISAT
  • ISAT
    • Endovascular coiling
    • versus
    • Neurosurgical clipping
    • Endovascular coiling
    • 1073 patients
    • Neurosurgical clipping
    • 1070 patients
    • Endovascular coiling
    • 1073 patients
    • Neurosurgical clipping
    • 1070 patients
    • Endovascular coiling
    • 1073 patients
    • Neurosurgical clipping
    • 1070 patients
    • RANDOMIZED
    • Is
    • this
    • worthwhile?
  • Death
  • ISAT
    • Dead or dependent at one year
    24% Endovascular 31% Neurosurgery
  • Endovascular coiling
    • Use of endovascular coils
    75-85% 2007 ~0% 1990
  • Treatments for stroke: from suggestion through randomised trials to routine clinical practice 1920 1930 1940 1950 1960 1970 1980 1990 2000 Coiling ruptured aneurysms Cholesterol  - 2 0 prevention BP  - acute stroke BP  - 2 0 prevention Thrombolysis - acute stroke Warfarin in SR - 2 0 prevention Warfarin in AF - 2 0 prevention Heparin - acute stroke Neuroprotection - acute stroke Aspirin - acute stroke Thienopyridines - 2 0 prevention Dipyridamole + asp - 2 0 prevention Aspirin - 2 0 prevention Carotid angioplasty Carotid endarterectomy
  • Example
  • Pregnancy
    • What’s the difference between midwifery led care and consultant led care?
  • MidU Study
  • MidU
    • Midwifery led care
    • versus
    • Consultant led care
    • Midwifery led care
    • versus
    • Consultant led care
    • Midwifery led care
    • versus
    • Consultant led care
    • Midwifery led care
    • versus
    • Consultant led care
    • 1500 women
    • Midwifery led care
    • versus
    • Consultant led care
    • 1500 women
    • RANDOMIZED
    • Is
    • this
    • worthwhile?
  • MidU Results
    • ?
    • Why were ISAT and MidU so sure that the answer was not already available?
    • Systematic reviews
  • Systematic reviews
  • What is a systematic review?
    • Scientific research
    • Seeks to minimise bias
    • Avoids undue emphasis on a single trial
    • Maximises the power of previous research
  • Why do we need systematic reviews?
    • Overwhelming amount of healthcare literature
    • New research is rarely reported in context
    • Reliable knowledge is essential for better health care
    • Better health care is essential for better health.
  • Overwhelming amount of healthcare literature
      • “ Over two million articles are published annually in the biomedical literature in over 20,000 journals - literally a small mountain of information, [a stack] would rise 500 metres”
    • Mulrow. Systematic Reviews (BMJ Publishing Group, 1995)
  • health
  •  
  •  
  • Example
  • Early (operable) breast cancer
    • Does tamoxifen reduce the risk of cancer recurrence and death?
  • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) Overview Tamoxifen versus no immediate tamoxifen
    • 30 years of research
    • 88% of worldwide data in the overview
    • 56 randomized trials
    • 48,000 women
    • 18,000 deaths
  • Tamoxifen vs no tamoxifen, 1998
  • Avoiding undue emphasis on individual trials
  • How sure are we about this treatment?
  • How sure are we about this treatment?
  • Tamoxifen for 5 years (ER+), 2005 Breast cancer death Recurrence
  • Tamoxifen versus no immediate tamoxifen
    • ER+, All ages: Breast cancer mortality over a decade
    38% 18% Tamoxifen (5 years) 50% 25%
    • Is
    • this
    • worthwhile?
  •  
  •  
  • What resources are available to help?
  •  
  • Cochrane Database of Systematic Reviews Issue 1, 2008
    • Contains the full text for
    • 3300 full Cochrane reviews
    • 1800 protocols for Cochrane reviews
  • The Cochrane Library Regional subscriptions
    • Australia
    • India
    • Ireland
    • Denmark
    • England
    • Finland
    • Northern Ireland
    • Norway
    • Saskatchewan
    • Scotland
    • South Africa
    • Spain
    • Wales
    • Wyoming
    • HINARI
    • INASP
    • BIREME
    • Plain language summary
    • Structured abstract
    • Background
    • Objectives
    • Eligibility criteria
      • Studies
      • Participants
      • Interventions
      • Outcome measures
    • Search strategy
    • Methods
    • Description of studies
    • Methodological quality
    • Results
    • Discussion
    • Authors’ conclusions
      • Implications for practice
      • Implications for research
    • Acknowledgements
    • Potential conflict of interest
    • References
    • Tables
    • Analyses
    Cochrane Systematic Reviews
  • Cochrane Systematic Reviews
    • Plain language summary
    • Structured abstract
    • Background
    • Objectives
    • Eligibility criteria
      • Studies
      • Participants
      • Interventions
      • Outcome measures
    • Search strategy
    • Methods
    • Description of studies
    • Methodological quality
    • Results
    • Discussion
    • Authors’ conclusions
      • Implications for practice
      • Implications for research
    • Acknowledgements
    • Potential conflict of interest
    • References
    • Tables
    • Analyses
  • Implications for Practice (2006) 84 (3%) Only use in research 1409 (50%) Uncertain 206 (7%) Intervention doesn’t work 1305 (47%) Intervention works 2801 All Cochrane reviews
  • Implications for Research (2005) 82 (3%) No more research 1315 (52%) Types of outcome 765 (30%) Types of participant 2079 (82%) Types of intervention 2535 All Cochrane reviews
    • Is
    • this
    • worthwhile?
  • National Institute for Health Research Estimate of costs
    • Contribution to the infrastructure costs of Cochrane Review Groups in the UK:
    • £10,000 per review
    • Commissioning of a review under the Health Technology Assessment programme:
    • £140,000 per review
  • Use of Cochrane reviews in UK guidelines and policy
    • 54 NICE guidelines: 572 citations to Cochrane reviews
    • 49 SIGN guidelines: 271 citations
    • 12 Health Evidence Bulletins (Wales): 234 citations
    • 56 Royal College’s guidelines: 226 citations
    • 130 Clinical Knowledge Summaries: 518 citations
    • 91 NHS HTA Reports: 306 citations
  • Influencing public policy: You are important
    • What role do you want the findings of randomised trials and systematic reviews to have in influencing public policy?
    • What role do you want the conduct of randomised trials and systematic reviews to have as part of public policy?
    • Better evidence
    • Better evidence
    • better knowledge and policy
    • Better evidence
    • better knowledge and policy
    • better health care
    • Better evidence
    • better knowledge and policy
    • better health care
    • better health
  • Some web addresses
    • The Cochrane Collaboration
    • www.cochrane.org
    • The Cochrane Library
    • www.thecochranelibrary.com
  • Some web addresses
    • The Cochrane Collaboration
    • www.cochrane.org
    • The Cochrane Library
    • www.thecochranelibrary.com