![]() In trials in which key outcomes are self-reported (eg, visual analogue scale, pain diary), the assessor is considered to be blind if the subject was blind.Įxplanation: Blinding of subjects involves ensuring that subjects were unable to discriminate whether they had or had not received the treatment. In addition, subjects and therapists are 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. Note on administration: Blinding means the person in question (subject, therapist or assessor) did not know which group the subject had been allocated to. ![]() Gross discrepancies between groups may be indicative of inadequate randomisation procedures. This criterion is satisfied even if only baseline data of study completers are presented.Įxplanation: This criterion may provide an indication of potential bias arising by chance with random allocation. The rater must be satisfied that the groups’ outcomes would not be expected to differ, on the basis of baseline differences in prognostic variables alone, by a clinically significant amount. ![]() Note on administration: At a minimum, in studies of therapeutic interventions, the report must describe at least one measure of the severity of the condition being treated and at least one (different) key outcome measure at baseline. the groups were similar at baseline regarding the most important prognostic indicators ![]() There is empirical evidence that concealment predicts effect size (concealment is associated with a finding of more modest treatment effects see Schulz et al, JAMA 1995 273:408-12). This could produce systematic biases in otherwise random allocation. Potentially, if allocation is not concealed, the decision about whether or not to include a person in a trial could be influenced by knowledge of whether the subject was to receive treatment or not. A point is awarded for this criteria, even if it is not stated that allocation was concealed, when the report states that allocation was by sealed opaque envelopes or that allocation involved contacting the holder of the allocation schedule who was “off-site”.Įxplanation: “Concealment” refers to whether the person who determined if subjects were eligible for inclusion in the trial was aware, at the time he or she made this decision, which group the next subject would be allocated to. Note on administration: Concealed allocation means that the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, of which group the subject would be allocated to. Quasi-randomised allocation procedures such as allocation by hospital record number or birth date, or alternation, do not satisfy this criterion.Įxplanation: Random allocation ensures that (within the constraints provided by chance) treatment and control groups are comparable. Procedures such as coin-tossing and dice-rolling should be considered random. The precise method of randomisation need not be specified. Note on administration: A study is considered to have used random allocation if the report states that allocation was random. subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated an order in which treatments were received) This item is not used to calculate the PEDro score. It has been included in the PEDro scale so that all items of the Delphi scale are represented on the PEDro scale. Note on administration: This criterion is satisfied if the report describes the source of subjects and a list of criteria used to determine who was eligible to participate in the study.Įxplanation: This criterion influences external validity, but not the internal or statistical validity of the trial. More detail on each item is provided in the PEDro scale training program. This briefly explains why each item has been included in the PEDro scale. The PEDro scale was last amended on 21 June 1999.
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