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Where appropriate, guideline developers should include in the text a statement on the level, quality, relevance and strength of the evidence and recommendations made should reflect this statement.
2.2.1 The level and quality of evidence
The level of evidence and the quality of evidence need to be considered together.
‘Level of evidence’ refers to the study design used by investigators to minimise bias (see Appendix B). Level I, the highest level, is generally accorded to randomised clinical trials. A methodologically poor randomised trial (level II) may, however, provide a weaker basis for a recommendation than a high-quality observational study without randomisation, which can provide level III-2 evidence.
‘Quality of evidence’ refers to the methods used by investigators to minimise bias in study design and in the conduct of a study. The types of bias and their possible effects depend on the study type. There are now fairly well established criteria for assessing the quality of randomised trials; they concern the degree to which allocation to treatment groups is concealed from investigator and subject, whether the study is double blind, and the completeness of follow-up of subjects.
Methods of assessing the quality of non-randomised studies (levels III-2 and III-3) are less well established and the factors will probably vary depending on the study type. In general, factors that are likely to influence the estimate of the effect size are the methods used to select subjects for the trial, the comparability of the treatment and control (if there is one) groups, the methods of measuring outcomes, and the completeness of the follow-up.
The quality of systematic reviews also needs to be considered if they are being used as the basis of guideline development. Standard methods for conducting and reporting systematic reviews have been published (see Greenhalgh 1997).
Lack of empirical evidence
No formal level of evidence is attached to expert opinion, the findings of expert working parties, or anecdotal information. In the absence of empirical evidence, however, or where there is only poor-quality evidence, guidelines may in some instances contain recommendations based on findings outside the levels-of- evidence hierarchy. Such recommendations should be derived using a consensus approach
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