Holger Schünemann, MD, PhD Chair, Department of Clinical Epidemiology & Biostatistics Michael Gent Chair in Healthcare Research Professor of Clinical Epidemiology, Biostatistics and Medicine McMaster University, Hamilton, Canada Baltimore, May 5, 2009.
Holger Schünemann, MD, PhD
Chair, Department of Clinical Epidemiology & Biostatistics
Michael Gent Chair in Healthcare Research
Professor of Clinical Epidemiology, Biostatistics and Medicine
McMaster University, Hamilton, Canada
Baltimore, May 5, 2009
How Can We Assist Practitioners to Assess and Implement Meaningful Therapies for Their Patients: The Example of the GRADE Approach
In the past three years, Dr. Schünemann received no personal payments for service from the pharmaceutical industry. During that time, his research group received research grants and - until April 2008 - fees and/or honoraria that were deposited into research accounts from Chiesi Foundation, Pfizer, UnitedBioSource and Lily, as lecture fees related to research methodology. He is documents editor for the American Thoracic Society. Institutions or organizations that he is affiliated with likely receive funding from for-profit sponsors that are supporting infrastructure and research that may serve his work. He is a GRADE Working Group Member
A 13 year old girl who lives in rural Indonesia presented with flu symptoms and developed severe respiratory distress over the course of the last 2 days. She required intubation. The history reveals that she shares her living quarters with her parents and her three siblings. At night the family’s chicken stock shares this room too and several chicken had died unexpectedly a few days before the girl fell sick.
Interventions: antivirals, such as neuraminidase inhibitors oseltamivir and zanamivir
Population: Avian Flu/influenza A (H5N1) patients
Intervention:Oseltamivir (or Zanamivir)
Comparison: No pharmacological intervention
Outcomes: Mortality, hospitalizations, resource use, adverse outcomes, antimicrobial resistance
WHO Avian Influenza GL. Schunemann et al., The Lancet ID, 2007
B Class I
Recommendation for use of oral anticoagulation in patients with atrial fibrillation and rheumatic mitral valve disease
Clear separation of 2 issues:
1) 4 categories of quality of evidence: very low, low, moderate, or high quality?
2) Recommendation: 2 grades - weak or strong (for or against)?
Grades of Recommendation Assessment, Development and Evaluation
GRADE Working Group
CMAJ 2003, BMJ 2004, BMC 2004, BMC 2005, AJRCCM 2006, Chest 2006, BMJ 2008
The evidence for the effect of sublingual immunotherapy in children with allergic rhinitis on the development of asthma, comes from a single randomised trial with no description of randomisation, concealment of allocation, and type of analysis, no blinding, and 21% of children lost to follow-up. These very serious limitations would limit our confidence in the estimates of effect and likely lead to downgrading the quality of evidence.
Overall judgment required
A systematic review of topical treatments for seasonal allergic conjunctivitis showed that patients using topical sodium cromoglycate were more likely to perceive benefit than those using placebo. However, only small trials reported clinically and statistically significant benefits of active treatment, while a larger trial showed a much smaller and a statistically not significant effect. These findings suggest that smaller studies demonstrating smaller effects might not have been published.
Observational studies examining the impact of exclusive breastfeeding on development of allergic rhinitis in high risk infants showed a relative risk of 0.87 (95% CI: 0.48 to 1.58) that neither rules out important benefit nor important harm (Mimouni Bloch 2002).
(higher dose of brain radiation in childhood leukemia leads to greater risk of late malignancies)
Quality assessment criteria
Recommendation: In patients with confirmed or strongly suspected infection with avian influenza A (H5N1) virus, clinicians should administer oseltamivir treatment as soon as possible (strong recommendation, very low quality evidence).
Values and Preferences
Remarks: This 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