“Subjects were randomly allocated to groups.” (in a crossover study, subjects were randomly allocated an order in which treatments were received). A point for random allocation was awarded if random allocation of patients was stated in its methods. The precise method of randomization need not be specified. Procedures such as coin-tossing and dice-rolling were considered random. Quasi-randomization allocation procedures such as allocation by bed availability did not satisfy this criterion.
“Allocation was concealed.” A point was awarded for concealed allocation if this was explicitly stated in the methods section or if there was reference that allocation was by sealed opaque envelopes or that allocation involved contacting the holder of the allocation schedule who was "off-site."
“The groups were similar at baseline regarding the most important prognostic indicators.” A trial was awarded a point for baseline comparability if at least one key outcome measure at baseline was reported for the study and control groups. This criterion was satisfied even if only baseline data of study completed-only subjects were presented.
“There was blinding of all subjects.” The person in question (subject, therapist or assessor) was considered blinded if he/she did not know which group the subject had been allocated to. In addition, subjects and therapists were only considered to be "blind" if it could be expected that they would have been unable to distinguish between the treatments applied to different groups. In drug therapy trials, the administrator of the drug was considered the therapist and was considered blinded if he/she did not prepare the drug and was unaware of the drug being administered.
“There was blinding of all therapists who administered the therapy.” (criteria 4.)
“There was blinding of all assessors who measured at least one key outcome” (criteria 4).
“Adequacy of follow-up.” For the purposes of this review, follow-up was considered adequate if all of the subjects that had been originally randomized could be accounted for at the end of the study. The interpretation of this criterion differs from that described by PEDro, where adequacy is defined as the measurement of the main outcome in more than 85% of subjects.
“Intention to treat.” All subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analyzed by "intention to treat". For purpose of the present evidence-based review, a trial was awarded a point for intention-to-treat if the trial explicitly stated that an intention-to-treat analysis was performed.
“The results of between-group statistical comparisons are reported for at least one key outcome.” Scoring of this criterion was design dependent. As such, between groups comparison may have involved comparison of two or more treatments, or comparison of treatment with a control condition. The analysis was considered a between-group analysis if either a simple comparison of outcomes measured after the treatment was administered was made, or a comparison of the change in one group with the change in another was made. The comparison may be in the form of hypothesis testing (e.g. p-value) or in the form of an estimate (e.g. the mean, median difference, difference in proportion, number needed to treat, relative risk or hazard ratio) and its confidence interval. A trial was awarded a point for this criterion if between group comparison on at least one outcome measure was made and its analysis of comparison was provided.
“The study provides both point measures and measures of variability for at least one key outcome.” A point measure was referred as to the measure of the size of the treatment effect. The treatment effect was described as being either a difference in group outcomes, or as the outcome in (each of) all groups. Measures of variability included standard deviations, standard errors, confidence intervals, interquartile ranges (or other quartile ranges), and ranges. Point measures and/or measures of variability that were provided graphically (for example, SDs may be given as error bars in a Figure) were awarded a point as long as it was clear what was being graphed (e.g. whether error bars represent SDs or SEs). For those outcomes that were categorical, this criterion was considered to have been met if the number of subjects in each category was given for each group.