Making proper judgments about the quality of scientific evidence and recommendations can be complex for scientists, let alone lawyers litigating drug and medical device litigation. Nevertheless, if you are an attorney wading through published scientific papers, it is your job to effectively grapple with these complexities.
Making proper judgments about the quality of scientific evidence and recommendations can be complex for scientists, let alone lawyers litigating drug and medical device litigation. Nevertheless, if you are an attorney wading through published scientific papers, it is your job to effectively grapple with these complexities. With this in mind, the GRADE working group developed the Grade of Recommendation, Assessment, Development, and Evaluation (GRADE) system to help untangle such difficult decisions.
GRADE is a system which provides clear and concise guidance for rating the quality of evidence and the strength of recommendations. GRADE presents great value for those summarizing evidence for systematic reviews, health technology assessment, and clinical practice guidelines. The system is a systematic and transparent framework for clarifying questions, determining the outcomes of interest, summarizing the evidence that addresses a question, and moving from the evidence to a recommendation or decision.
The GRADE system appeals to scientists, physicians, epidemiologists, and attorneys. GRADE is increasingly being adopted by organizations worldwide, many highly influential, attesting to its importance.
Earlier this year, The Journal of Clinical Epidemiology began publishing a 20-part series providing guidance for the use of GRADE methodology. Nine parts of the series have been published, and the remainder will appear in 2012 issues of the journal.
How does the GRADE system classify quality of evidence?
The GRADE system classifies the quality of evidence into four levels: High, Moderate, Low, and Very Low. Evidence based on randomized controlled trials begins as high quality evidence, but confidence in the evidence may be decreased for a variety of reasons, including: Study limitations, Imprecision, Reporting bias, Inconsistency of results, Indirectness of evidence.
While observational studies (e.g. cohort and case-control studies) are initially given a “low quality” rating, grading upwards will occur if the magnitude of the treatment effect is very large, if there is evidence of a dose-response relationship, or if all reasonable biases would reduce the extent of an apparent treatment effect.
How does the GRADE system consider strength of recommendation?
The GRADE system offers two grades of recommendations: “strong” and “weak.” Strong recommendations are offered when the desirable effects of an intervention clearly outweigh the undesirable effects, or vice versa. However, when the “benefit-to-risk” profile is less certain, which often occurs because of low quality evidence or because the data suggest that desirable and undesirable effects are in equilibrium, weak recommendations are made.
What does GRADE do for me?
This series should prove to be useful to any lawyer focusing on published science, by providing a framework with which to assert the quality and reliability of your evidence and to criticize the quality of evidence of your adversaries.
The GRADE system offers a systematic and explicit approach to making scientific judgments. GRADE guidelines may help prevent errors, facilitate critical appraisal of judgments, and improve communication of this information.
More information on GRADE:
The Journal of Clinical Epidemiology 2011 GRADE series list:
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