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Depending on perspective, different expert panels, professional organizations, or individual physicians may use different cut points of overall strength of evidence in formulating therapeutic guidelines or in taking action; however, a formal description of the level of evidence provides a uniform framework for the data, leading to specific recommendations.The PDQ Adult Treatment Editorial Board and the PDQ Pediatric Treatment Editorial Board add information on levels of evidence, described below, to the PDQ Adult Cancer Treatment Summaries and the PDQ Pediatric Cancer Treatment Summaries when appropriate.
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Unfortunately, most clinical trials in oncology cannot be double-blinded after treatment allocation because procedures or toxic effects often vary substantially among study allocations in ways that are obvious to both the health care professional and the patient.
Outcomes of the large, randomized, controlled trials were not predicted accurately by the meta-analysis 35% of the time.[1,2] Meta-analyses performed by different investigators to address the same clinical issue can reach contradictory conclusions. Therefore, meta-analyses of randomized studies are placed in the same category of strength of evidence as are randomized studies, not at a higher level.
Subset analyses of randomized studies are subject to errors inherent in multiplicity (i.e., statistically significant results to be expected as a result of random variation of measured effects in multiple subsets).
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The randomized, double-blinded, controlled, clinical trial (1i) is the gold standard of study design.