PEDRO Scale

Danish Hassan
Riphah International University

What is the PEDro scale

Clinical trials indexed on the PEDro database are rated with a checklist
called the "PEDro scale"

Developed to help the users of the PEDro database to rapidly identify

clinical trials that are likely to be internally valid and have sufficient
statistical information to make their results interpretable

The PEDro scale considers two aspects of trial quality, namely the
1. Believability / Internal Validity (Item 2-9)
2. Whether The Trial Contains Sufficient Statistical Information To Make
It Interpretable (Items 10-11)

ITEM: 1 Eligibility Criteria And Source

Criterion: 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.

PEDro scale item 1 relates to external validity or generalisability, but not

the internal validity or statistical reporting of the trial. Because it does
not evaluate internal validity or statistical reporting it is not included in
the PEDro score.

To fulfill this item the report needs to describe BOTH the source of
subjects AND the eligibility criteria used to select subjects. If only one
aspect is described it would score a no

ITEM 2: Random Allocation

Criterion: Subjects were randomly allocated to groups

A study is considered to have used random allocation if the report states

that allocation was random.

The precise method of randomisation need not be specified.

Procedures such as coin-tossing and dice-rolling should be considered

random.

Quasi-randomisation allocation procedures such as allocation by hospital

record number or birth date, or alternation, do not satisfy this criterion.

ITEM 3: Concealed Allocation

Criterion: Allocation was concealed

Concealed allocationmeans 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.

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 or not otherwise involved in
the study.

Concealment of allocation is the process used to ensure that the person

deciding to enter a participant into a randomised controlled trial does
not know the comparison group into which that individual will be
allocated.

This is distinct from blinding, and is aimed at preventing selection bias

ITEM 4: Baseline comparability

Criterion: The groups were similar at baseline regarding the most

important prognostic indicators

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 outcomemeasure at baseline.

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.

This criterion is satisfied even if only baseline data of study completers

are presented.

ITEMS 5, 6 AND 7:
Blinding of subjects, therapists and assessors

These three items on the PEDro scale deal with blinding or masking, and
will be considered together.

Criterion 5: There was blinding of all subjects

Criterion 6: There was blinding of all therapists who administered the

therapy

Criterion 7: There was blinding of all assessors who measured at least

one key outcome

Blindingmeans the person in question (subject, therapist or assessor) did not

know which group the subject had been allocated to.

Blinding of subjects involves ensuring that subjects were unable to

discriminate whether they had or had not received the treatment

Blinding of therapists involves ensuring that therapists were unable to

discriminate whether individual subjects had or had not received the
treatment

Blinding of assessors involves ensuring that assessors were unable to

discriminate whether individual subjects had or had not received the
treatment

Reports sometimes use the terms single-blind, double-blind and triple-blind.

The problem with using these terms is that there are no accepted definitions,
so that the same terms may be used to describe different types of blinding in
different trials.

ITEM 8: Adequate follow-up

Criterion: Measures of at least one key outcome were obtained from

more than 85% of the subjects initially allocated to groups

In trials in which outcomes are measured at several points in time, akey

outcomemust have been measured in more than 85% of subjects at one
of those points in time.

The rater needs to judge which outcomes are key outcomes and which
follow-up periods are key follow-up periods.

The cut-off is 85%, so if 85% of subjects initially allocated to groups

have data for a key outcome at follow-up the record will score a no for
this item while if > 85% of subjects initially allocated to groups have
data for a key outcome at follow-up will score a yes.

ITEM 9: Intention-to-treat
analysis

Criterion: 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 analysed by
intention to treat

Anintention-to-treatanalysis means that, where subjects did not receive

treatment (or the control condition) as allocated and where measures of
outcomes were available, the analysis was performed as if subjects
received the treatment (or control condition) they were allocated to.

This criterion is satisfied, even if there is no mention of analysis by

intention to treat, if the report explicitly states that all subjects received
treatment or control conditions as allocated.

ITEM 10: Between-group

comparisons

Abetween-groupstatistical comparison involves statistical comparison of

one group with another.

Depending on the design of the study, this may involve comparison of two
or more treatments, or comparison of treatment with a control condition.

The analysis may be a simple comparison of outcomes measured after the

treatment was administered, or a comparison of the change in one group
with the change in another.

The comparison may be in the form of hypothesis testing (which provides

a p value, describing the probability that the groups differed only by
chance) or in the form of an estimate (for example, the mean or median
difference, or a difference in proportions, the number needed to treat, a
relative risk or a hazard ratio) and its confidence interval.

ITEM 11: Point estimates and

variability

Criterion: The study provides both point measures and measures of

variability for at least one key outcome

Apoint measureis a measure of the size of the treatment effect. The

treatment effect may be described as a difference in group outcomes, or
as the outcome in (each of) all groups.

Measures of variabilityinclude standard deviations, standard errors,

confidence intervals, interquartile ranges (or other quartile ranges), and
ranges.

For continuous data, the type of point estimate (eg, mean or median)
and the type of variability (eg, standard deviation or standard error)
needs to be specified.

For categorical data (eg, able to walk independently versus not able
to walk independently), this criterion is achieved if the number of
subjects in each category for each group are reported.