Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate

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Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues.

Guideline developers use a bewildering variety of systems to rate the quality of the evidence underlying their recommendations. Some are facile, some confused, and others sophisticated but complexIn 2004 the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group presented its initial proposal for patient management. In this second of a series of five articles focusing on the GRADE approach to developing and presenting recommendations we show how GRADE has built on previous systems to create a highly structured, transparent, and informative system for rating quality of evidence.A guideline's formulation should include a clear question Any question addressing clinical management has four components: patients, an intervention, a comparison, and the outcomes of interest.2 For example, consider the following: in patients with pancreatic carcinoma undergoing surgery, what is the impact of a modified resection that preserves the pylorus compared with a standard wide tumour resection-variations of the Whipple procedure-on short term and long term mortality, blood transfusions, bile leaks, hospital stay, and problems with gastric emptying?Guideline developers should address the importance of their outcomes GRADE challenges guideline developers to specify all outcomes that are of importance to patients as they begin the guideline development process, and to differentiate the critical outcomes from the important but not critical ones.3 Figure 1 presents a hierarchy of patient important outcomes regarding the impact of phosphate lowering drugs in patients with renal failure. GRADE suggests a nine point scale to judge importance. The upper end of the scale, 7 to 9, identifies outcomes of critical importance for decision making. Ratings of 4 to 6 represent outcomes that are important but not critical. Ratings of 1 to 3 are items of limited importance. Guideline panels should strive for the sort of explicit approach that this example represents.Judging the quality of evidence requires consideration of the context GRADE provides a definition for the quality of evidence in the context of making recommendations. The quality of evidence reflects the extent to which confidence in an estimate of the effect is adequate to support recommendations. This definition has two important implications. Firstly, guideline panels must make judgments about the quality of evidence relative to the specific context in which they are using the evidence. Secondly, because systematic reviews do not-or at least should not-make recommendations, they require a different definition. For systematic reviews, the quality of evidence reflects the extent of confidence that an estimate of effect is correct.Study design is important in determining the quality of evidence As with early systems of grading the quality of evidence, 4 GRADE's approach begins with the study design. For recommendations addressing alternative management strategies-as opposed to issues of establishing prognosis or the accuracy of diagnostic testsrandomise...

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