D

RCTs* - rich body of data

RCTs* - limited body of data

Non-randomized trials, observational studies

Panel consensus judgment

Evidence is from endpoints of well-designed RCTS (or trials that depart only minimally from randomization) that provide a consistent pattern of findings in the population for which the recommendation is made. Requires substantial numbers of studies involving substantial numbers of subjects

Evidence is from endpoints of intervention studies that include only a limited number of RCTs, post-hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. Category B pertains when few RCTs exist, they are small in size, and the trial results are somewhat inconsistent, or the trials were undertaken in a population that differs from the target population of the recommendation

Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies

Expert judgment is based on the panel's synthesis of evidence from experimental research described in the literature and/or derived from the consensus of panel members based on clinical experience or knowledge that does not meet the above criteria. This category is used only in cases where the provision of some guidance was deemed valuable but an adequately compelling clinical literature addressing the subject of the recommendation was deemed insufficient to justify placement in one of the other categories (A-C)

* RCT = randomized controlled trial

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