TABLE 5. Description of materials and methods.

Is there an adequate description of the source of participants (hospital, outpatient clinic, etc.) and the timing and duration of recruitment? Is there an adequate description of the entry and exclusion criteria?  Has the method of approach to potential participants and the information given to them been described?  Is there a satisfactory description of the actual way in which the treatments were assigned, and the use of prognostic stratification, if any?  Have the forms of care compared (the treatment regimens), both experimental and control, been described in sufficient detail to allow replication?  Has the degree of masking (" blinding "), if any, of participants and investigators been described?  If a placebo was used, was there an assessment of its success in " masking " the nature of the treatment?  Have the methods used to measure outcome been described, specifying whether or not the assessor knew the treatment allocation (" degree of masking ")?  Has the objective been specified in terms of a quantified effect on a defined primary measure of outcome?  Is there an explanation of how the final sample size was chosen and a statement on statistical power in respect of the quantified effect on the primary measure of outcome?  If there were any interim analyses, have the arrangements and methods used been described?  Have all the statistical methods been identified and is there a description of any statistical techniques used which are not in common use?

Source: Grant (9).