Plenary 3 Co-chairs:   Sally Green and Helen Whelton Pembroke
Challenges and opportunities in international evidence based guideline development  Suzanne Hill October 2006
 
 
<ul><li>'Critical appraisal of the JNC VI, WHO/ISH and BHS guidelines for essential hypertension.' </li></ul><ul><li>'Thes...
<ul><li>Implementation of WHO/ISH Guidelines: role and activities of WHO. 'In order to increase its impact, however, an im...
<ul><li>'World health organisation-international society of hypertension (WHO/ISH) hypertension guidelines.' </li></ul><ul...
Progress report?  <ul><li>Essential Medicines List </li></ul><ul><li>Opioid dependence </li></ul><ul><li>Avian influenza <...
Essential medicines <ul><li>The concept of essential medicines </li></ul><ul><li>A limited range of carefully selected ess...
The Essential Medicines Target S S All the drugs in the world Registered medicines National list of essential medicines Le...
Global application  Countries with an official selective list for training, supply, reimbursement or related health object...
Evidence for the 15 th  list? <ul><li>306 medicines </li></ul><ul><li>Over 50% of drugs have a relevant Cochrane review </...
 
And the gaps…
Treatment of African trypanosomiasis and visceral and cutaneous leishmaniasis. Pentamidine powder for injection 2nd line t...
And gaps for additions….. <ul><li>Viral haemorrhagic fevers – ribavirin </li></ul><ul><li>Evidence for paediatric formulat...
 
Opioid dependence <ul><li>Comprehensive guideline </li></ul><ul><li>Target audience policy makers and clinicians </li></ul...
Process <ul><li>Guideline group  </li></ul><ul><li>Identification of evidence </li></ul><ul><li>Systematic reviews </li></...
GRADE Evidence Profile Author(s):  Amato L Date:  02/02/2006 16.01.56 Question:  Should methadone vs buprenorphine be used...
Problems <ul><li>Studies mostly come from developed world settings </li></ul><ul><li>Research gaps </li></ul><ul><li>Revie...
 
Avian influenza <ul><li>Needed in a hurry –  clinical uncertainties </li></ul><ul><li>Money available </li></ul><ul><li>Fl...
Defined clinical questions -  scope Are there systematic reviews/ HTAs available? Commission evidence profile and summarie...
Evidence summaries
Recommendations
Clinical uncertainty <ul><li>Cochrane review in seasonal influenza – reported relative results only </li></ul><ul><li>Clin...
 
What about the rest? <ul><li>Prevention of post partum haemorrhage </li></ul><ul><ul><li>Drafted last week </li></ul></ul>...
<ul><li>Could do better….. </li></ul>
 
 
Challenges for Cochrane <ul><li>Not just ‘what works’? </li></ul><ul><li>Or what is interesting? </li></ul><ul><li>Better ...
Challenges for global EBD <ul><li>Neglected diseases  </li></ul><ul><li>Old drugs </li></ul><ul><li>Neglected populations ...
 
 
Plenary 3 Co-chairs:   Sally Green and Helen Whelton Pembroke
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The Cochrane Collaboration Colloquium: Challenges and opportunities in international evidence-based guideline developments

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Suzanne Hill speaking at the XIV Cochrane Colloquium in Dublin, Ireland

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The Cochrane Collaboration Colloquium: Challenges and opportunities in international evidence-based guideline developments

  1. 1. Plenary 3 Co-chairs: Sally Green and Helen Whelton Pembroke
  2. 2. Challenges and opportunities in international evidence based guideline development Suzanne Hill October 2006
  3. 5. <ul><li>'Critical appraisal of the JNC VI, WHO/ISH and BHS guidelines for essential hypertension.' </li></ul><ul><li>'These differing recommendations between JNC VI and BHS, and WHO/ISH cannot be reconciled and they are of such magnitude as to carry serious implications for clinical practice, not least among which is that acceptance of the WHO/ISH levels of 'normality' for blood pressure would result in some 45% of the population of all ages and nearly 60% of elderly people being classified as 'hypertensive'.' </li></ul>O'Brien & Staessen, 2000
  4. 6. <ul><li>Implementation of WHO/ISH Guidelines: role and activities of WHO. 'In order to increase its impact, however, an implementation strategy is needed that includes advocacy, dissemination, training and evaluation as its major components.' </li></ul>Martin, Clin Exper Hypertens, 2000
  5. 7. <ul><li>'World health organisation-international society of hypertension (WHO/ISH) hypertension guidelines.' </li></ul><ul><li>'Since the publication of the 1999 WHO/ISH Guidelines for the Management of Hypertension, WHO determined in 2000 that in future the evidence base for all of its guidelines will be explicitly documented according to a defined methodology. ' </li></ul>Whitworth JA, Chalmers J. Clin Exper Hypertens 2004
  6. 8. Progress report? <ul><li>Essential Medicines List </li></ul><ul><li>Opioid dependence </li></ul><ul><li>Avian influenza </li></ul>
  7. 9. Essential medicines <ul><li>The concept of essential medicines </li></ul><ul><li>A limited range of carefully selected essential medicines leads to better health care, better drug management, and lower costs </li></ul><ul><li>Definition of essential medicines </li></ul><ul><li>Essential medicines are those that satisfy the priority health care needs of the population </li></ul><ul><li>(Report to WHO Executive Board, January 2002) </li></ul>
  8. 10. The Essential Medicines Target S S All the drugs in the world Registered medicines National list of essential medicines Levels of use Supplementary specialist medicines CHW dispensary Health center Hospital Referral hospital Private sector
  9. 11. Global application Countries with an official selective list for training, supply, reimbursement or related health objectives. Some countries have selective state/provincial lists instead of or in addition to national lists.
  10. 12. Evidence for the 15 th list? <ul><li>306 medicines </li></ul><ul><li>Over 50% of drugs have a relevant Cochrane review </li></ul><ul><li>Some reviews raise questions over inclusion on the list </li></ul><ul><li>eg. antacids, allopurinol </li></ul><ul><li>Linked through Essential Medicines Library </li></ul>
  11. 14. And the gaps…
  12. 15. Treatment of African trypanosomiasis and visceral and cutaneous leishmaniasis. Pentamidine powder for injection 2nd line therapy for late stage African trypanosomiasis due to Trypanosoma brucei gambiense. Eflornithine injection Treatment of African trypanosomiasis. Suramin sodium powder for injection Treatment of African trypanosomiasis. Melarsoprol injection Treatment of cutaneous sporotrichosis. Potassium iodide saturated solution Treatment of multi-drug resistant TB Ethionamide tablet Second line treatment of multi-drug resistant TB Cycloserine capsule or tablet Treatment of leprosy as part of combination therapy, (paucibacilliary and multibacilliary). Dapsone tablet Treatment of multibacilliary leprosy Clofazamine capsule Treatment of infections with susceptible organisms including: methicillin-resistant staphylococcal pneumonia, staphylococcal meningitis, endocarditis treatment and prophylaxis. Vancomycin powder for injection Treatment of fascioliasis and paragonimiasis. Triclabendazole tablet Treatment of tapeworm Niclosamide chewable tablet Used as a supplement to standard treatment for P vivax and ovale to eradicate dormant parasites from the liver and prevent relapses. Primaquine tablet
  13. 16. And gaps for additions….. <ul><li>Viral haemorrhagic fevers – ribavirin </li></ul><ul><li>Evidence for paediatric formulations </li></ul><ul><li>Reviews for old cardiovascular drugs </li></ul><ul><li>Review for a statin </li></ul>
  14. 18. Opioid dependence <ul><li>Comprehensive guideline </li></ul><ul><li>Target audience policy makers and clinicians </li></ul><ul><li>Potential for significant change </li></ul><ul><ul><li>Access to medications </li></ul></ul><ul><ul><li>Access to health care service </li></ul></ul><ul><ul><li>Reduction in blood-borne disease </li></ul></ul>
  15. 19. Process <ul><li>Guideline group </li></ul><ul><li>Identification of evidence </li></ul><ul><li>Systematic reviews </li></ul><ul><li>Evidence profiles </li></ul><ul><li>Recommendations </li></ul><ul><li>Consultation </li></ul>
  16. 20. GRADE Evidence Profile Author(s): Amato L Date: 02/02/2006 16.01.56 Question: Should methadone vs buprenorphine be used in all opioid dependent patients? Patient or population: any opioid dependent patients wishing to detox Settings: outpatients Systematic review: Gowing. Buprenorphine for the management of opioid withdrawal Amato Methadone at tapered doses for the management of opioid withdrawal 1   Moderate WMD -5.1 3 (-14 to 5.3) - Imprecise or sparse data (-1) 4 No uncertainty No important inconsistency No limitations Randomised trials 1 side effects (objective measures Range: to . Better indicated by: lower scores) 1   Low 100/1 000 (290 less to 100 more) RR 0.88 (0.67 to 1.15) 26/33 (78,8%) 21/30 (70%) Imprecise or sparse data (-1) 1 Some uncertainty (-1) 1 No important inconsistency No limitations Randomised trials 2 completion of treatment (number of people that completed the treatment Follow up: 14 to 30 days) Absolute (95% CI) Relative (95% CI) buprenorphine methadone Other considerations Directness Consistency Limitations Design No of studies Importance Quality Effect No of patients Summary of findings Quality assessment <ul><li>imprecise or sparse data </li></ul><ul><li>imprecise or sparse data: only 63 patients </li></ul><ul><li>difference in systolic blood pressure </li></ul><ul><li>only one study with 39 patients </li></ul>Footnotes:
  17. 21. Problems <ul><li>Studies mostly come from developed world settings </li></ul><ul><li>Research gaps </li></ul><ul><li>Reviews do not report outcomes relevant for decision-making </li></ul><ul><ul><li>summary estimates of symptom scores </li></ul></ul><ul><ul><li>harms / adverse events </li></ul></ul><ul><li>Time spent going back to original studies </li></ul><ul><li>Time spent commissioning extra reviews </li></ul><ul><li>… .guideline still going…… </li></ul>
  18. 23. Avian influenza <ul><li>Needed in a hurry – clinical uncertainties </li></ul><ul><li>Money available </li></ul><ul><li>Flexible process </li></ul><ul><li>Extensive collaboration </li></ul>
  19. 24. Defined clinical questions - scope Are there systematic reviews/ HTAs available? Commission evidence profile and summaries Convene guideline panel Define critical outcomes for decision making Consumers input Draft guideline – secretariat, standard format PANEL MEETING Guideline finalised, peer reviewed USE-BY DATE, plan for updat e 3 MONTHS Commission systematic reviews
  20. 25. Evidence summaries
  21. 26. Recommendations
  22. 27. Clinical uncertainty <ul><li>Cochrane review in seasonal influenza – reported relative results only </li></ul><ul><li>Clinical evidence in H5N1 accruing on the basis of case reports </li></ul><ul><li>Clinical trials planned but not yet recruiting </li></ul><ul><li>Role of animal studies </li></ul>
  23. 29. What about the rest? <ul><li>Prevention of post partum haemorrhage </li></ul><ul><ul><li>Drafted last week </li></ul></ul><ul><ul><li>Based on systematic reviews and GRADE </li></ul></ul><ul><ul><li>Needed re-analysis </li></ul></ul><ul><ul><li>Problems with trials, not reviews - evidence for harms </li></ul></ul><ul><li>Oncology </li></ul><ul><ul><li>Reviews for some priority diseases </li></ul></ul><ul><ul><li>Gaps for developing world studies </li></ul></ul><ul><ul><li>Gaps for new products </li></ul></ul><ul><li>Acute care in children </li></ul><ul><ul><li>300 questions </li></ul></ul><ul><ul><li>30 reviews </li></ul></ul>
  24. 30. <ul><li>Could do better….. </li></ul>
  25. 33. Challenges for Cochrane <ul><li>Not just ‘what works’? </li></ul><ul><li>Or what is interesting? </li></ul><ul><li>Better reviews </li></ul><ul><li>And more of them </li></ul>
  26. 34. Challenges for global EBD <ul><li>Neglected diseases </li></ul><ul><li>Old drugs </li></ul><ul><li>Neglected populations </li></ul><ul><li>Reviews not answering relevant questions </li></ul><ul><li>Harms and adverse effects </li></ul><ul><li>Access to unpublished data </li></ul><ul><li>Capacity </li></ul><ul><li>Global coverage </li></ul><ul><li>Format </li></ul><ul><li>Policymakers versus clinicians </li></ul><ul><li>……… </li></ul>
  27. 37. Plenary 3 Co-chairs: Sally Green and Helen Whelton Pembroke

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