Evidence For Physiotherapy Practice: A Survey of The Physiotherapy Evidence Database (Pedro)

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Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

Evidence for physiotherapy practice: A survey of the


Physiotherapy Evidence Database (PEDro)

Anne M Moseley, Robert D Herbert, Catherine Sherrington and Christopher G Maher


Centre for Evidence-Based Phyiotherapy, The University of Sydney

Evidence-based practice involves the use of evidence from systematic reviews and randomised controlled trials, but the
extent of this evidence in physiotherapy has not previously been surveyed. The aim of this survey is to describe the quantity
and quality of randomised controlled trials and the quantity of systematic reviews relevant to physiotherapy. The
Physiotherapy Evidence Database (PEDro) was searched. The quality of trials was assessed with the PEDro scale. The
search identified a total of 2,376 randomised controlled trials and 332 systematic reviews. The first trial was published in 1955
and the first review was published in 1982. Since that time, the number of trials and reviews has grown exponentially. The
mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published
between 1995 and 1999. There is a substantial body of evidence about the effects of physiotherapy. However, there remains
scope for improvements in the quality of the conduct and reporting of clinical trials. [Moseley AM, Herbert RD, Sherrington
C and Maher CG (2002): Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database
(PEDro). Australian Journal of Physiotherapy 48: 43-49]

Key words: Evidence-Based Medicine; Meta-Analysis; Physical Therapy; Randomized Controlled Trials

Introduction To be included on PEDro, randomised controlled trials


must fulfil the following criteria:
Over the past decade, physiotherapists have been
encouraged to take an evidence-based approach to the • the trial compares at least two interventions (ie at
teaching and practice of physiotherapy (eg MacIntyre et al least one intervention compared with a control or
1999, Research Committee (Victorian Branch) of the sham, or a comparison of two or more interventions);
Australian Physiotherapy Association and contributors • at least one of the interventions is currently part of
1999). Evidence-based practice has been defined by physiotherapy practice, or could become part of
Sackett et al (2000, p. 246) as “the conscientious, explicit physiotherapy practice;
and judicious use of current best evidence in making • the interventions are applied to human subjects who
decisions about the care of individual patients”. This are representative of those to whom the intervention
involves “integrating individual clinical expertise with the might be applied in the course of physiotherapy
best available external clinical evidence from systematic practice (ie people with or at risk of developing a
research”. The best available evidence of the benefits and health condition or disability);
harms of therapy is provided by systematic reviews of
randomised controlled trials (Level I) and well-designed • there is random allocation or intended-to-be-random
randomised (Level II) or pseudo-randomised (Level III-1) allocation of subjects to interventions; and
controlled trials (National Health and Medical Research • the trial is published as a full paper in a peer-reviewed
Council 2000). Many physiotherapists have only limited journal.
access to this high level evidence (due partly to restricted
access to databases that archive clinical trials and reviews The second criterion has been interpreted broadly in order
or even an awareness of these databases), which has led to to include the range of treatments that may be used by
the belief that there is little evidence about the effects of physiotherapists internationally. Systematic reviews are
physiotherapy interventions (Bithell 2000). included on PEDro if they are published in a peer reviewed
journal, contain a methods section, and review at least one
The Physiotherapy Evidence Database (PEDro) was trial that satisfies the above criteria.
launched in October 1999 to support an evidence-based
approach to the teaching and practice of physiotherapy To assist users of PEDro to interpret the results of research,
(Sherrington et al 2000). It is a free, Internet-based randomised controlled trials on the database are rated for
resource (http://ptwww.cchs.usyd.edu.au/pedro) developed methodological quality by trained PEDro staff or volunteer
and maintained by the Centre for Evidence-Based physiotherapists (all raters complete a training package and
Physiotherapy. PEDro contains bibliographic details and pass a rating accuracy test) using the PEDro scale (see
author abstracts of systematic reviews and randomised Appendix 1). This scale is based on the Delphi list
controlled trials in physiotherapy. developed by Verhagen et al (1998), a nine-item list

Australian Journal of Physiotherapy 2002 Vol. 48 43


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

2500 Randomised controlled trials 600


Cumulative number of records

Systematic reviews
2000 500

Number of trials
400
1500
300
1000
200
500
100

0 0
1955

1960

1965

1970

1975

1980

1985

1990

1995
2000
0 1 2 3 4 5 6 7 8 9 10

Total PEDro score


Year

Figure 1. Cumulative number of randomised controlled Figure 2. Frequency distribution of the total PEDro score
trials and systematic reviews in physiotherapy by year. for the 2,297 randomised controlled trials with quality
ratings.

established by expert consensus (items: eligibility criteria the physiotherapy profession for a number of reasons. This
specified, subjects randomly allocated to groups, concealed information can assist the profession in identifying areas of
allocation, groups similar at baseline, blinding of subjects, practice that have not been well evaluated. Most
therapists and assessors, intention-to-treat analysis, point importantly, this information could guide the profession in
measures and measures of variability reported). Two deciding what services should be part of contemporary
additional items not on the Delphi list have been included physiotherapy practice. An evidence-based practice
in the PEDro scale (ie outcome measures obtained from perspective would suggest that the profession should
more than 85% of subjects and reporting of results of discontinue using treatments that are clearly ineffective and
between-group statistical comparisons). Four PEDro scale should consider take-up of new treatments when there is
items have been validated empirically in the medical evidence that they are effective.
literature: randomisation, concealed allocation, blinding,
and adequacy of follow-up (Moher et al 1999). The other This survey aims to describe the quality and quantity of
items have face validity but are yet to be empirically randomised controlled trials and the quantity of systematic
validated. The PEDro scale has been shown to have reviews indexed on PEDro. As PEDro probably is the most
acceptable inter-rater reliability (Moseley et al 1999). complete database of trials and reviews in physiotherapy,
Observed agreement for individual PEDro items ranged this survey will provide some insights into the scope of
from 70% (groups similar at baseline) to 96% (blinding of evidence that can be used to guide decisions about the
therapists), and the intraclass correlation coefficient for the effects of therapy. The PEDro database is unique in that it
total PEDro score (ie the score derived from adding all provides a measure of the quality of the randomised
PEDro scale items except the specification of eligibility controlled trials it indexes. This permits statements to be
criteria) was 0.54. To increase the accuracy of quality made about the quality of randomised controlled trials in
ratings on the PEDro database, each trial is independently physiotherapy.
rated by two reviewers, with a third rater arbitrating on
items where consensus cannot be reached.
Method
The extent of the external evidence relevant to neurological
physiotherapy archived on PEDro has recently been Data were extracted from PEDro on April 17, 2001. The
surveyed (Moseley et al 2000). There were 238 randomised authors, title, source, year of publication, publication type
controlled trials (54% were categorised as being of (randomised controlled trial or systematic review) and
moderate to high quality, rating five or more out of 10 on quality scores for the records were analysed. Three
the PEDro scale) and 27 systematic reviews relevant to analyses were performed. The first focused on the amount
neurological physiotherapy. However, the quantity and of external evidence available each year. Cumulative totals
quality of the external evidence on therapy relevant to other of randomised controlled trials and systematic reviews
subdisciplines of physiotherapy or physiotherapy in general were calculated. The relationship between the quantity of
has not been surveyed. Information on the quantity and reviews and trials and the year of publication was described
quality of the external evidence on therapy is important to using least-squares non-linear curve fitting.

44 Australian Journal of Physiotherapy 2002 Vol. 48


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

1955 - 1959 4 Eligibility criteria


1960 - 1964 10 Random allocation
1965 - 1969 15 Concealed allocation
1970 - 1974 41 Groups similar at baseline
96 Subject binding
1975 - 1979
210 Therapist binding
1980 - 1984
Assessor binding
1985 - 1989 426
< 15% dropouts
1990 - 1994 634
Intention-to-treat analysis
1995 - 1999 759 Between-group statistical comparisons
2000 - 2001 102 Point measures and variability data

0 1 2 3 4 5 6 7 8
0 20 40 60 80 100
Total PEDro score % of randomised controlled trials

Figure 3. Mean and standard deviation of the total PEDro Figure 4. Percentage of rated randomised controlled trials
score of rated randomised controlled trials in physiotherapy that satisfied each item of the PEDro scale.
for each 5-year period since 1955 (plus the trials published
in 2000 or 2001). The number of trials for each epoch is
indicated at the end of each bar.

The second analysis investigated the methodological number of randomised controlled trials has increased
quality of the randomised controlled trials. The analysis of rapidly and approximately exponentially since then (Figure
methodological quality was performed on the sub-set of 1). An exponential growth curve fits the data well (number
trials that had been quality rated using the PEDro scale (the of trials = e 0.18 x years since 1955; r2 = 0.94). An average of 155
remaining trials had bibliographic information entered on trials were published each year from 1995 to 1999.
the PEDro database but had not yet been rated). The mean
and standard deviation of the total PEDro score (ie the The first archived systematic review relevant to
score derived by adding all scale items except for Item 1, physiotherapy was published in 1982 and investigated the
the specification of eligibility criteria) for five-year epochs effects of weight loss treatments (including exercise) on
and the frequency distribution of the total PEDro score for hypertension (Hovell 1982). Since then, there has been an
all rated trials were calculated. In addition, the percentage exponential increase in the number of systematic reviews,
of trials satisfying each of the items on the PEDro scale with 59 published in 1999. Again, an exponential growth
was determined. curve fits the data very well (number of reviews =
e 0.33 x years since 1982; r2 = 0.99).
The last analysis examined the evidence available for each
subdiscipline of physiotherapy. All PEDro records were Of the 2,376 randomised controlled trials archived on
coded for up to three areas of physiotherapy PEDro at April 17, 2001, 2,297 (or 97%) had been rated for
(cardiothoracics, continence and women’s health, methodological quality at least once and 1,235 (52%) had
ergonomics and occupational health, gerontology, ratings confirmed by a second or third rater (the remaining
musculoskeletal, neurology, orthopaedics, paediatrics, and 79 trials had bibliographic information entered on the
sports – see Appendix 2). The number of randomised PEDro database but had not yet been rated). Trial quality
controlled trials and systematic reviews were calculated for ranged from 0/10 to 10/10, with most rating 4 or 5 (Figure
each area of physiotherapy. 2). Fifty-two per cent of trials were nominally of moderate
to high quality, rating 5 or more on the PEDro scale.
Results The quality of randomised controlled trials in
physiotherapy has increased gradually since 1955 (Figure
There were 2,708 records indexed on PEDro. Of these, 3). The mean total PEDro score has increased from 2.8 for
2,376 were randomised controlled trials and 332 were trials published between 1955 and 1959, to 5.0 for trials
systematic reviews (that is, one systematic review for every published between 1995 and 1999 (the mean for trials
7.2 trials)(a). Most records (93%) were in English. The first published in 2000 or 2001 is 5.7).
archived trials in physiotherapy were published in 1955(a),
about seven years after the first modern randomised The percentage of rated randomised controlled trials that
controlled trial in medicine (Medical Research Council satisfy each item on the PEDro scale is illustrated in Figure
1948). These trials investigated manipulation for low back 4. Most trials (94%) fulfilled the randomisation item of the
pain (Coyer and Curwen 1955) and wax baths for PEDro scale (ie subjects were randomly allocated to
rheumatoid arthritis (Harris and Millard 1955). The experimental conditions). This is not surprising given that

Australian Journal of Physiotherapy 2002 Vol. 48 45


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

trials are only eligible for PEDro if they use a randomised


or intended-to-be-randomised method of allocation. Other Musculoskeletal
high-rating PEDro scale items were the reporting of Gerontology
between-group statistical comparisons (89% of trials) and Cardiothoracics
the provision of point estimates and measures of variability Neurology
(82% of trials). The trials showed lower compliance for Orthopaedics
three features that have been shown to predict bias in Sports
clinical trials (concealed allocation to groups, blinding, and Women’s Health
adequacy of follow-up; Moher et al 1999). Only 16% Paediatrics
clearly used concealed allocation and 59% of trials clearly Ergonomics Randomised controlled trials
had a dropout rate of less than 15%. The prevalence of Other Systematic reviews
blinding was low. Very few trials used blinded therapists
(5% of trials) or subjects (9% of trials), but about one-third 0 200 400 600 800 1000 1200
(34% of trials) blinded the assessors. Only 12% of trials
reported using an intention-to-treat analysis. Number of records

The systematic reviews and randomised controlled trials


covered most areas of physiotherapy (Figure 5). Note that Figure 5. Number of randomised controlled trials and
the columns in this figure do not tally with the total number systematic reviews available in each area of physiotherapy
(columns do not tally with the total number of trials on
of records on PEDro because trials and reviews can be PEDro because trials and reviews can be coded for up to
relevant to more than one area of physiotherapy. Trials and three areas of physiotherapy).
reviews can be coded for up to three areas of physiotherapy.
The ‘other’ category in Figure 5 is used when the record
cannot be classified using the subdiscipline definitions (see
Fifty-two per cent of trials were of moderate to high
Appendix 2). The largest number of trials and reviews
quality, rating 5 or more on the PEDro scale, and the mean
(39% of trials and 36% of reviews) were in the area of
PEDro score has been increasing since the first randomised
musculoskeletal physiotherapy.
controlled trial in physiotherapy was published in 1955.
This means there is a significant amount of Level II and
Discussion Level III-1 evidence that is likely to be valid and to have
sufficient statistical information to make the results
Contrary to popular belief, there is a significant body of interpretable. Such information can guide the practice and
evidence to guide the practice and teaching of teaching of physiotherapy.
physiotherapy. Much of this evidence is archived on PEDro
which, in April 2001, contained 2,376 randomised The methodological quality of randomised controlled trials
controlled trials and 332 systematic reviews. This may be archived on PEDro was assessed using the PEDro scale.
an underestimate of the amount of evidence, although it is While the PEDro scale has adequate reliability (Moseley et
difficult to estimate how many trials and reviews are not on al 1999), it has not been empirically validated. However,
the PEDro database. Trials published in languages other the PEDro scale does include the four features known to
than English are probably significantly under-represented minimise bias in clinical trials (ie randomisation, concealed
because the majority of PEDro staff and volunteers are allocation, blinding, and minimising the dropout rate;
fluent in English only. Moher et al 1999), and the remaining items have face
There were randomised controlled trials and systematic validity. Several of the items that have not been empirically
reviews relevant to all subdisciplines of physiotherapy. Not validated were nominated by a panel of experts as being
surprisingly, the largest number of trials and reviews were indicative of methodological quality (Verhagen et al 1998).
in the area of musculoskeletal physiotherapy. The evidence The total PEDro score may be used by physiotherapists as
for neurological physiotherapy, which had been surveyed a guide to differentiate trials that are more likely to be valid
previously (Moseley et al 2000), ranked fourth. Paediatrics and contain sufficient statistical information to be
and ergonomics were the areas of physiotherapy with the interpretable from those that are not.
smallest number of trials and reviews. These areas could be
The quality of the conduct and reporting of future trials in
priority areas for future research funding.
physiotherapy could be improved. Only a small proportion
While the PEDro database contains 332 systematic of physiotherapy trials reported three features that have
reviews, it is likely that many clinical questions in been shown to predict bias in clinical trials (concealed
physiotherapy are yet to be addressed by these reviews. It is allocation to groups, blinding and adequate follow-up).
unclear from this survey whether this is primarily due to a While concealed allocation is theoretically possible in all
lack of randomised controlled trials in particular areas or a randomised trials, only 16% of physiotherapy trials clearly
lack of systematic reviews summarising completed trials. report using concealed allocation. Similarly, blinding of the
assessors of outcomes should almost always be possible,
A substantial number of the randomised controlled trials in but was only evident in 34% of the trials archived on
physiotherapy are nominally of moderate to high quality. PEDro. Blinding of therapists may not be possible in many

46 Australian Journal of Physiotherapy 2002 Vol. 48


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

trials that evaluate exercise, manual therapy and education, Conclusion


but it should be possible in trials that evaluate
electrotherapies such as laser and ultrasound. This survey of the Physiotherapy Evidence Database
(PEDro) revealed a significant body of high level external
While it is desirable to blind subjects, this is difficult for evidence (both randomised controlled trials and systematic
many physiotherapy interventions. Two recent papers have reviews) that can be used to support decision-making about
shown some interesting approaches to this difficult therapy for all subdisciplines of physiotherapy. The amount
problem. Streitberger and Kleinhenz (1998) reported a of evidence is expanding at an exponential rate and the
protocol for sham acupuncture that patients could not quality of trials is increasing. While there is a relatively
distinguish from real acupuncture. The protocol uses a large amount of high quality evidence available, there still
‘sham’ needle that retracts into the handle when it touches remains scope for improvements in the quality of the
the skin. The patients feel a pricking sensation and see the conduct and reporting of clinical trials.
shortening of the needle as would occur with real
acupuncture. Van Tulder et al (2000) have advocated that Footnote (a) Since this paper was accepted for publication,
where blinding is not feasible, the use of a sham treatment the PEDro database has continued to expand. In January
that was demonstrated to be equally credible and 2002 PEDro contained 2,712 randomised controlled trials
acceptable to the patient should be regarded as passing the and 411 systematic reviews. We have also identified some
criterion for subject blinding if the trial formally assesses trials that were published before the first trials in
the equal credibility of treatment. In contrast, Vickers and physiotherapy cited in this paper. Two trials were published
de Craen (2000) have argued that sham or placebo- before 1955, both in the area of cardiothoracic
controlled trials sacrifice external validity for internal physiotherapy. They are Palmer and Sellick (1952) and
validity and do not inform clinical decision making as well Palmer and Sellick (1953).
as trials in which the control group is not administered a
sham therapy. Acknowledgements Financial support for PEDro has been
provided by the Motor Accidents Authority of New South
Like randomised controlled trials, the quality of systematic Wales, the New South Wales Physiotherapists Registration
reviews vary. While the methodological quality of Board, and the Australian Physiotherapy Association. The
systematic reviews have not been evaluated on the PEDro support of the Rehabilitation and Related Therapies Field
database, physiotherapists could use a number of resources of the Cochrane Collaboration, the School of
to identify reviews that are likely to be valid. First, the Physiotherapy at The University of Sydney, the
quality of Cochrane systematic reviews is likely to be high Rehabilitation Studies Unit at The University of Sydney,
as they are performed according to stringent guidelines. PEDro staff, and the volunteer physiotherapists who have
Second, the Database of Abstracts of Reviews of assisted with literature searching and the quality rating of
Effectiveness (DARE; University of York 2000) provides trials is also acknowledged.
structured abstracts and quality assessments for many of
the systematic reviews archived on PEDro. About 50% of Authors Anne Moseley, Rehabilitation Studies Unit,
the systematic reviews relevant to neurological Department of Medicine, The University of Sydney, Royal
physiotherapy have structured abstracts on DARE Rehabilitation Centre, Post Office Box 6, Ryde, New South
(Moseley et al 2000). Third, readers can assess individual Wales 1680. E-mail: amoseley@mail.usyd.edu.au (for
systematic reviews for the presence of features known to correspondence). Robert Herbert, School of Physiotherapy,
introduce bias. The filters suggested by the National Health The University of Sydney, Post Office Box 170, Lidcombe,
and Medical Research Council (2000) include the New South Wales 1825. Catherine Sherrington, Prince of
adequacy of the search strategy used, the use of appropriate Wales Medical Research Institute, Barker Street,
inclusion criteria that were applied in an unbiased way, Randwick, New South Wales 2231. Christopher Maher,
quality assessment of included studies, the appropriate School of Physiotherapy, The University of Sydney, Post
summarising of the characteristics and results of the Office Box 170, Lidcombe, New South Wales 1825.
individual studies, the use of appropriate methods for
pooling the data, and exploration of sources of References
heterogeneity.
The amount of external evidence about therapy relevant to Bithell C (2000): Evidence-based physiotherapy: some
physiotherapy is significant and growing at an exponential thoughts on ‘best evidence’. Physiotherapy 86: 58-60.
rate. This poses a challenge to even the most dedicated Coyer AB and Curwen IH (1955): Low back pain treated by
physiotherapist who, based on current publication rates, manipulation. A controlled series. British Medical Journal
would have to read approximately 155 trials and 59 reviews 1: 705-707.
each year to keep abreast of the physiotherapy literature. Harris R and Millard JB (1955): Paraffin-wax baths in the
Some solutions to this problem of information overload are treatment of rheumatoid arthritis. Annals of Rheumatic
to restrict reading to the area of current practice, read only Diseases 14: 278-283.
high quality randomised controlled trials and systematic Hovell MF (1982): The experimental evidence for weight-
reviews, and make use of distilled literature such as the loss treatment of essential hypertension: a critical review.
Critically Appraised Papers section of this journal. American Journal of Public Health 72: 359-368.

Australian Journal of Physiotherapy 2002 Vol. 48 47


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

MacIntyre DL, McAuley CA and Parker-Taillon D (1999): Appendix 1: Criteria for the PEDro scale
Canadian physiotherapy research and evidence-based
practice initiative in the 1990s. Physical Therapy Reviews 1 eligibility criteria were specified
4: 127-137.
Medical Research Council (1948): Streptomycin treatment
2 subjects were randomly allocated to groups (in a
of pulmonary tuberculosis. British Medical Journal crossover study, subjects were randomly allocated an
ii: 769-782. order in which treatments were received)
Moher D, Cook DJ, Jadad AR, Tugwell P, Moher M, Jones 3 allocation was concealed
A, Pham B and Klassen TP (1999): Assessing the quality 4 the groups were similar at baseline regarding the
of reports of randomised trials: implications for the
most important prognostic indicators
conduct of meta-analyses. Health Technology
Assessment 3: 1-98. 5 there was blinding of all subjects
Moseley AM, Maher C, Herbert RD and Sherrington C 6 there was blinding of all therapists who administered
(1999): Reliability of a scale for measuring the the therapy
methodological quality of clinical trials. Proceedings of the
VIIth Cochrane Colloquium. Rome, p. 39. 7 there was blinding of all assessors who measured at
least one key outcome
Moseley A, Sherrington C, Herbert R and Maher C (2000):
The extent and quality of evidence in neurological 8 measures of at least one key outcome were obtained
physiotherapy: an analysis of the Physiotherapy Evidence from more than 85% of the subjects initially allocated
Database (PEDro). Brain Impairment 1: 130-140. to groups
National Health and Medical Research Council (2000): How 9 all subjects for whom outcome measures were
to Use the Evidence: Assessment and Application of available received the treatment or control condition
Scientific Evidence. Canberra: Biotext. as allocated or, where this was not the case, data for
Palmer KNV and Sellick BA (1952): Effect of procaine at least one key outcome was analysed by “intention
penicillin and breathing exercises in postoperative to treat”
pulmonary complications. Lancet 1: 345-346.
10 the results of between-group statistical comparisons
Palmer KNV and Sellick BA (1953): The prevention of are reported for at least one key outcome
postoperative pulmonary atelectasis. Lancet 1: 164-168.
11 the study provides both point measures and measures
Research Committee (Victorian Branch) of the APA and
contributors (1999): Evidence-based practice. Australian of variability for at least one key outcome
Journal of Physiotherapy 45: 167-171. Notes on administration of the PEDro scale:
Sackett DL, Straus SE, Richardson WS, Rosenberg W and
Haynes RB (2000): Evidence-Based Medicine: How to All criteria Points are only awarded when a criterion is
Practice and Teach EBM. (2nd ed.) Edinburgh: Churchill clearly satisfied. If on a literal reading of the trial report it
Livingstone. is possible that a criterion was not satisfied, a point should
Sherrington C, Herbert RD, Maher CG and Moseley AM
not be awarded for that criterion.
(2000): PEDro: A database of randomized trials and Criterion 1 This criterion is satisfied if the report describes
systematic reviews in physiotherapy. Manual Therapy 5: the source of subjects and a list of criteria used to
223-226.
determine who was eligible to participate in the study.
Streitberger K and Kleinhenz J (1998): Introducing a
placebo needle into acupuncture research. Lancet Criterion 2 A study is considered to have used random
352: 364-365. allocation if the report states that allocation was random.
University of York, NHS Centre for Reviews and The precise method of randomisation need not be
Dissemination (2000): Database of Abstracts of Reviews specified. Procedures such as coin-tossing and dice-rolling
of Effectiveness. http://agatha.york.ac.uk/darehp.htm. should be considered random. Quasi-randomisation
(Accessed November 9, 2000.). allocation procedures such as allocation by hospital record
van Tulder M, Ostelo R, Vlaeyen J, Linton S, Morley S and number or birth date, or alternation, do not satisfy this
Assendelft W (2000): Behavioural treatment for chronic criterion.
low back pain. A systematic review within the framework
of the Cochrane Back Review Group. Spine Criterion 3 Concealed allocation means that the person
25: 2688-2699. who determined if a subject was eligible for inclusion in
Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, the trial was unaware, when this decision was made, of
Bouter LM and Knipschild PG (1998): The Delphi list: a which group the subject would be allocated to. A point is
criteria list for quality assessment of randomised clinical awarded for this criteria, even if it is not stated that
trials for conducting systematic reviews developed by allocation was concealed, when the report states that
Delphi consensus. Journal of Clinical Epidemiology allocation was by sealed opaque envelopes or that
51: 1235-1241. allocation involved contacting the holder of the allocation
Vickers AJ and de Craen AJM (2000): Why use placebos in schedule who was “off-site”.
clinical trials? A narrative review of the methodological
literature. Journal of Clinical Epidemiology 53: 157-161. Criterion 4 At a minimum, in studies of therapeutic

48 Australian Journal of Physiotherapy 2002 Vol. 48


Moseley et al: Evidence for physiotherapy practice: A survey of the Physiotherapy Evidence Database (PEDro)

interventions, the report must describe at least one measure (each of) all groups. Measures of variability include
of the severity of the condition being treated and at least standard deviations, standard errors, confidence intervals,
one (different) key outcome measure at baseline. The rater interquartile ranges (or other quantile ranges) and ranges.
must be satisfied that the groups’ outcomes would not be Point measures and/or measures of variability may be
expected to differ, on the basis of baseline differences in provided graphically (for example, SDs may be given as
prognostic variables alone, by a clinically significant error bars in a Figure) as long as it is clear what is being
amount. This criterion is satisfied even if only baseline data graphed (for example, as long as it is clear whether error
of study completers are presented. bars represent SDs or SEs). Where outcomes are
categorical, this criterion is considered to have been met if
Criteria 4, 7-11 Key outcomes are those outcomes which the number of subjects in each category is given for each
provide the primary measure of the effectiveness (or lack of group.
effectiveness) of the therapy. In most studies, more than
one variable is used as an outcome measure.
Criterion 5-7 Blinding means the person in question Appendix 2: PEDro definitions for each
(subject, therapist or assessor) did not know which group sub-discipline of physiotherapy
the subject had been allocated to. In addition, subjects and
therapists are only considered to be “blind” if it could be Cardiothoracics includes, but is not restricted to, papers
expected that they would have been unable to distinguish evaluating acute and rehabilitation cardiothoracic
between the treatments applied to different groups. In trials interventions or fitness training on those with conditions
in which key outcomes are self-reported (eg visual affecting the cardiothoracic system. This subdiscipline
analogue scale, pain diary), the assessor is considered to be does not include studies of general fitness training among
blind if the subject was blind. patient populations. Studies of general fitness training for
healthy populations are not indexed on PEDro
Criterion 8 This criterion is only satisfied if the report
explicitly states both the number of subjects initially Continence and women’s health includes, but is not
allocated to groups and the number of subjects from whom restricted to, male and female incontinence and pre- and
key outcome measures were obtained. In trials in which post-natal interventions for the mother
outcomes are measured at several points in time, a key
outcome must have been measured in more than 85% of Ergonomics and occupational health includes, but is not
subjects at one of those points in time. restricted to, interventions based at workplaces or on
workers for work-related conditions
Criterion 9 An intention to treat analysis means that,
where subjects did not receive treatment (or the control Gerontology includes papers where the average age of the
condition) as allocated, and where measures of outcomes study sample is over 60, and papers on conditions which
were available, the analysis was performed as if subjects commonly affect older people (eg arthritis)
received the treatment (or control condition) they were Musculoskeletal includes, but is not restricted to, low back
allocated to. This criterion is satisfied, even if there is no pain, rheumatoid disease, entrapment syndromes and
mention of analysis by intention to treat, if the report neuralgia
explicitly states that all subjects received treatment or
control conditions as allocated. Neurology includes, but is not restricted to, lesions of the
central and peripheral nervous systems excluding those
Criterion 10 A between-group statistical comparison whose primary presentation is pain or paraesthesia such as
involves statistical comparison of one group with another. carpal tunnel syndrome, neuralgia or sciatica
Depending on the design of the study, this may involve
comparison of two or more treatments, or comparison of Orthopaedics includes only fractures and intervention
treatment with a control condition. The analysis may be a before or after orthopaedic surgery (eg knee replacements,
simple comparison of outcomes measured after the ligament repairs)
treatment was administered, or a comparison of the change
in one group with the change in another (when a factorial Paediatrics includes papers where the average age of the
analysis of variance has been used to analyse the data, the study sample is under 16, and papers on conditions which
latter is often reported as a group × time interaction). The commonly affect children (eg cystic fibrosis)
comparison may be in the form hypothesis testing (which Sports includes papers which specifically mention sports
provides a p value, describing the probability that the injuries as well as conditions which commonly affect sports
groups differed only by chance) or in the form of an people (eg ligament repairs)
estimate (for example, the mean or median difference, or a
difference in proportions, or number needed to treat, or a If the area for a particular paper does not fit under any of
relative risk or hazard ratio) and its confidence interval. the above categories, the code “no appropriate value in this
field” is used.
Criterion 11 A point measure is 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

Australian Journal of Physiotherapy 2002 Vol. 48 49

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