Report in English with a Dutch summary (KCE reports 45A)

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194 Screening for Colorectal Cancer: Appendices KCE reports vol.45 Grade Not Assignable (N/A): There is no evidence available that directly supports or refutes the conclusion. The symbols +, , ø, and N/A found on the conclusion grading worksheets are used to designate the quality of the primary research reports and systematic reviews: + indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generalizability, and data collection and analysis; indicates that these issues have not been adequately addressed; ø indicates that the report or review is neither exceptionally strong or exceptionally weak; N/A indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed. National Comprehensive Cancer Network (NCCN - USA) Categories of Consensus The NCCN Guidelines Steering Committee has devised a set of Categories of Consensus. These annotations contain two dimensions: the strength of the evidence behind the recommendation and the degree of consensus about its inclusion: Category 1: the recommendation is based on high-level evidence (i.e., high-powered randomized clinical trials or metaanalyses), and the Guideline Expert Panel has reached uniform consensus that the recommendation is indicated. In this context, uniform means near unanimous positive support with some possible neutral positions. Category 2A: the recommendation is based on lower level evidence, but despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II or large cohort studies to individual practitioner experience. Importantly, in many instances, the retrospective studies are derived from clinical experience of treating large numbers of patients at a member institution, so panel members have first-hand knowledge of the data. Inevitably, some recommendations must address clinical situations for which limited or no data exist. In these instances the congruence of experience-based opinions provide an informed if not confirmed direction for optimizing patient care. These recommendations carry the implicit recognition that they may be superseded as higher level evidence becomes available or as outcomes-based information becomes more. Category 2B: the recommendation is based on lower level evidence, and there is non-uniform consensus that the recommendation should be made. In these instances, because the evidence is not conclusive, institutions take different approaches to the management of a particular clinical scenario.
KCE reports vol.45 Screening for Colorectal Cancer: Appendices 195 This non-uniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data. Category 3: including the recommendation has engendered a major disagreement among the panel members. The level of evidence is not pertinent in this category, because experts can disagree about the significance of high level trials. Several circumstances can cause major disagreements. For example, if substantial data exist about two interventions but they have never been directly compared in a randomized trial, adherents to one set of data may not accept the interpretation of the other side's results. Another situation resulting in a Category 3 designation is when experts disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation issue in the data and directs them to the manuscript for an explanation of the controversy. National Health & Medical Research Council (NHMRC Australia) Levels of evidence Strength of recommendations I - Evidence obtained from a systematic review of all relevant randomised controlled trials II - Evidence obtained from at least one properly designed randomised controlled trial III-I - Evidence obtained from well-designed pseudo randomised controlled trials (alternate allocation or some other method) III-2 - Evidence obtained from comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, casecontrol studies, or interrupted time series with a control group III-3 - Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group IV - Evidence obtained from case series, either post-test or pretest/post-test. The strength of recommendations are determined by a expert advisory panel taking into account the level of evidence, quality of studies, size of effect and clinical importance for all the included studies, and ranges from Strongly recommended to Strongly not recommended . These levels of recommendation are modified from The Canadian Task Force on the Periodic Health: Strongly recommended : clinically significant level I in favour of clinical question strongly recommended in favour.
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Report in English with a Dutch summary (KCE reports 45A)

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