Quality criteria derived from research

Three main factors related to study reporting have been associated with altering the estimation of the risk estimate, usually by inflating the claimed benefit.3 These are shown in Box 9.1.

Generation and concealment of treatment allocation

Generation and concealment of treatment allocation are two interrelated steps in the crucial process of randomisation. The first refers to the method used to generate the randomisation sequence. The second refers to the subsequent steps taken by the trialists to conceal the allocation of participants to the intervention groups from the people recruiting the participants. Suggestions for adequate and inadequate definitions of generation of randomisation and subsequent concealment are shown in Box 9.2. Studies that do not describe how the randomisation sequence was generated should be viewed with some suspicion, given that humans frequently subvert the intended aims of randomisation.5

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