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This article is the first of a series providing guidance for the use of the GRADE system of rating quality of evidence and grading strength of recommendations in systematic reviews, health technology assessments, and clinical practice guidelines addressing alternative management options. The GRADE process begins with asking an explicit question, including(More)
In the GRADE approach, randomized trials are classified as high quality evidence and observational studies as low quality evidence but both can be rated down if a body of evidence is associated with a high risk of publication bias. Even when individual studies included in best-evidence summaries have a low risk of bias, publication bias can result in(More)
GRADE suggests that examination of 95% confidence intervals (CIs) provides the optimal primary approach to decisions regarding imprecision. For practice guidelines, rating down the quality of evidence (i.e., confidence in estimates of effect) is required when clinical action would differ if the upper versus the lower boundary of the CI represented the(More)
This article deals with inconsistency of relative, rather than absolute, treatment effects in binary/dichotomous outcomes. A body of evidence is not rated up in quality if studies yield consistent results, but may be rated down in quality if inconsistent. Criteria for evaluating consistency include similarity of point estimates, extent of overlap of(More)
Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of(More)
GRADE requires a clear specification of the relevant setting, population, intervention, and comparator. It also requires specification of all important outcomes - whether evidence from research studies is, or is not, available. For a particular management question, the population, intervention, and outcome should be sufficiently similar across studies so(More)
The objectives of this paper are to describe the status and development of health technology regulation with regard to coverage decisions and utilization, and to analyze the current situation of health technology assessment (HTA) in Germany. The relevant literature for controlling health technologies was identified by searching the literature and databases(More)
Critics claim that most of the German clinical practice guidelines are of poor quality having produced by informal ad hoc methodologies without a rigorous approach. This paper reports on the systematic appraisal of 329 guidelines published online by the Association of the Scientific Medical Societies (AWMF) in Germany. The results of this study suggest that(More)
GRADE requires guideline developers to make an overall rating of confidence in estimates of effect (quality of evidence-high, moderate, low, or very low) for each important or critical outcome. GRADE suggests, for each outcome, the initial separate consideration of five domains of reasons for rating down the confidence in effect estimates, thereby allowing(More)
Recommendations already exist on how to write a structured abstract for the INAHTA Database (http://agatha.york.ac.uk/htahp.htm). The abstract must be written in English. In 392 INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 18:2, 2002 Best practice in undertaking and reporting HTA Table 15. Data To Be Included in an English Structured Abstract Title:(More)