Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials

Article Abstract:

Inadequate concealment of patient treatment allocation during randomized, controlled trials appears to lead to unreliable results. Randomized, controlled trials are used to evaluate drug therapy or other treatments. Thirty-three meta-analyses of the design of 250 controlled trials were analyzed. In 79 trials researchers judged that adequate steps were taken to conceal treatment allocation from participants. In 21 trials, inadequate steps were taken and in 150 trials researchers were unable to determine if steps to conceal treatment allocation were adequate. Significantly larger estimates of treatment effects occurred in trials in which concealment was unclear or inadequate than in trials judged to have provided adequate concealment. When evaluating studies, researchers should carefully assess whether biases in comparison groups exist.

Evaluation, Test bias

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Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement

Article Abstract:

An adapted Consolidated Standards of Reporting Trials (CONSORT) checklist for reporting noninferiority and equivalence trials is presented and illustrative examples and explanations for those items amended from the original CONSORT checklist are provided. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.

United States, Analysis, Records and correspondence, Equivalence relation (Set theory)

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Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published trials

Article Abstract:

An attempt is made to examine the extent and nature of outcome reporting bias in a cohort of randomized trials. The conclusion states that the reporting of trial outcomes is biased and inconsistent with protocols.

Science & research, Research, Evidence-based medicine

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