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

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188 Screening for Colorectal Cancer: Appendices KCE reports vol.45 These levels were generated in a series of iterations among members of the NHS R&D Centre for Evidence-Based Medicine (Bob Phillips, Chris Ball, Dave Sackett, Brian Haynes, Sharon Straus and Finlay McAlister). Notes 1. Users can add a minus-sign "-" to denote the level of that fails to provide a conclusive answer because of: o EITHER a single result with a wide Confidence Interval (such that, for example, an ARR in an RCT is not statistically significant but whose confidence intervals fail to exclude clinically important benefit or harm) o OR a Systematic Review with troublesome (and statistically significant) heterogeneity. 2. Grades of recommendation are shown as linked directly to a level of evidence. However levels speak only of the validity of a study not its clinical applicability. Other factors need to be taken into account (such as cost, easy of implementation, importance of the disease) before determining a grade. Grades that are currently in the guides link closely to the validity of the evidence - these will change over time to reflect better concerns that we highlight in the text of the guide or related CATs.
KCE reports vol.45 Screening for Colorectal Cancer: Appendices 189 By homogeneity we mean a systematic review that is free of worrisome variations (heterogeneity) in the directions and degrees of results between individual studies. Not all systematic * reviews with statistically significant heterogeneity need be worrisome, and not all worrisome heterogeneity need be statistically significant. As noted above, studies displaying worrisome heterogeneity should be tagged with a "-" at the end of their designated level. Clinical Decision Rule. (These are algorithms or scoring systems which lead to a prognostic estimation or a diagnostic category) See comment #2 for advice on how to understand, rate and use trials or other studies with wide confidence intervals. § Met when all patients died before the Rx became available, but some now survive on it; or when some patients died before the Rx became available, but none now die on it. By poor quality cohort study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both exposed and non-exposed individuals and/or failed to identify or appropriately control known confounders and/or failed to carry out a sufficiently long and complete follow- §§ up of patients. By poor quality case-control study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both cases and controls and/or failed to identify or appropriately control known confounders. §§§ Split-sample validation is achieved by collecting all the information in a single tranche, then artificially dividing this into "derivation" and "validation" samples. An "Absolute SpPin" is a diagnostic finding whose Specificity is so high that a Positive result rules-in the diagnosis. An "Absolute SnNout" is a diagnostic finding whose Sensitivity is so high that a Negative result rules-out the diagnosis. Better-value treatments are clearly as good but cheaper, or better at the same or reduced cost. Worse-value treatments are as good and more expensive, or worse and equally or more expensive. Good reference standards are independent of the test, and applied blindly or objectively to applied to all patients. Poor reference standards are haphazardly applied, but still independent of the test. Use of a non-independent reference standard (where the 'test' is included in the 'reference', or where the 'testing' affects the 'reference') implies a level 4 study. Validating studies test the quality of a specific diagnostic test, based on prior evidence. An exploratory study collects information and trawls the data (e.g. using a regression analysis) to ** find which factors are 'significant'. By poor quality prognostic cohort study we mean one in which sampling was biased in favour of patients who already had the target outcome, or the measurement of outcomes was *** accomplished in 80%, with adequate time for alternative diagnoses to emerge (eg 1-6 months acute, 1 - 5 years chronic) Surrogate outcomes are considered validated only when the relationship between the surrogate outcome and the clinically important outcomes has been established in long-term RCTs.
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KCE reports 1. Effectiviteit en kos
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