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?
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Source: Grant (9).