1. Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, 703e709
REVIEW
Evolution of reports of randomised clinical trials
in plastic surgery
D.F. Veiga a,b,e,*, J. Veiga-Filho a,b,e, R.F. Pellizzon c,
Y. Juliano d, L.M. Ferreira a,e
a
˜o
˜o
Division of Plastic Surgery, Department of Surgery, Universidade Federal de Sa Paulo, Sa Paulo, Brazil
´
Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaı, Pouso Alegre, Brazil
c
˜o
˜o
Division of References, Central Library, Universidade Federal de Sa Paulo, Sa Paulo, Brazil
d
´
Department of Bioestatistics, Universidade do Vale do Sapucaı, Pouso Alegre, Brazil
e
˜o
˜o
Plastic Surgery Postgraduate Program e Universidade Federal de Sa Paulo, Rua Napolea de Barros,
˜o
715 e 4 andar - CEP 04024-002, Sa Paulo e SP, Brazil
b
Received 26 May 2010; accepted 16 November 2010
KEYWORDS
Randomised clinical
trials;
Plastic surgery;
Review literature as
topic;
Quality;
Evaluation
Summary Well-designed, well-conducted and well-reported randomised clinical trials
(RCTs) can significantly impact medical care, by contributing to a strong evidence base from
which clinical guidelines can be derived. In a previous study, we assessed the quality of
reports of RCTs in plastic surgery published from 1966 to 2003. The aim of the present study
was to verify what have changed over the last years. RCTs in plastic surgery published from
2004 to 2008 were identified through electronic searches, and classified according to their
allocation concealment. Trials with allocation concealment appropriately described were
evaluated as to their quality. Two independent reviewers performed the evaluations, using
two tools: the Delphi List and the Jadad’s quality scale. From 3840 identified studies, 96 were
selected for classification according to allocation concealment; 28 (29%) of them appropriately described allocation concealment. From 1966 to 2003, 34 (17%) RCTs appropriately
described allocation concealment (c2 Z 22.98, p 0.000). In the evaluation of the 28 RCTs
by the Delphi List, the agreement coefficient between raters (kw) was 0.46 (z Z 7.24,
p 0.000). Groups were similar at baseline in 96.4% of these trials, and this was the only item
of the Delphi List, which significantly improved when compared with the period from 1966 to
2003 (c2 Z 18.53, p 0.000). When evaluated by Jadad’s criteria, 14% of the RCTs were
scored two points or less and thus considered of low quality (kw Z 0.72, z Z 8.57,
p 0.001). From 1966 to 2003, 59% of RCTs were scored two points or less (c2 Z 17.07,
* Corresponding author. Rua Napoleao de Barros, 715 e 4 andar, CEP 04024-002, Sao Paulo e SP, Brazil. Tel.: þ55 35 34223298; fax: þ55
˜
˜
35 34223299.
E-mail address: danifveiga@uol.com.br (D.F. Veiga).
1748-6815/$ - see front matter ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.bjps.2010.11.015

2. 704
D.F. Veiga et al.
p 0.004). We concluded that the quality of reports of RCTs in plastic surgery (as measured
by the Jadad’s criteria and only one component of the nine components of the Delphi List)
significantly increased over the last years.
ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by
Elsevier Ltd. All rights reserved.
Research in plastic surgery will have a greater impact on
clinicians’ practice if higher-impact-level studies are published.1 Considering the growing demands for state-of-theart treatment, and the limited health-care resources,
increasing interest is being focussed on the practice of
evidence-based medicine.2e4
The randomised controlled trial (RCT) is defined as a study
design in which patients are allocated at random to an
intervention group or to a control group.2,5,6 Well-designed
RCTs provide the highest level of evidence in health-care
interventions, and their outcomes can significantly impact
medical care, by contributing to a strong evidence base from
which clinical guidelines can be derived.7,8
The essence of evidence-based medicine is the integration of clinical expertise with the best available
evidence from systematic research.2,9 By systematically
identifying and assessing the reporting and methodologic
quality of RCTs and their impact in our speciality, we can
improve evidence-based practice in plastic surgery, thus
directly benefiting our patients.2,8
However, the application of evidence-based medicine,
and specifically the RCT, to surgical research has been slower
than in medical specialities.3,4,10,11 The execution of a plastic
surgery RCT is challenging. Challenges include surgical equipoise, surgical learning curve, differential care, randomisation, concealment, blinding and loss to follow-up, among
others.3,4 Despite of the difficulties in conducting RCTs in
plastic surgery, if the field of plastic surgery is to advance, it
must adopt well-established methodologic principles.4
A previous study identified RCTs in plastic surgery published from 1966 to 2003, and assessed the quality of
reports of the RCTs, which have appropriately described
allocation concealment.12 The aim of the present study was
to evaluate the quality of reports of RCTs in plastic surgery
published from January 2004 to December 2008, using the
same tools, to verify what have changed over the last years.
Methods
An electronic search was conducted to identify the maximum
number of studies published as RCTs in plastic surgery, in the
English language, from January 2004 to December 2008.
Strategies of electronic search were elaborated for each
database consulted: Cochrane Controlled Trials Register
(CCTR), Excerpta Medica Database (EMBASE), Latin-American
and Caribbean Literature in Sciences of Health (LILACS) and
MEDLARS e Medical Literature Retrieval System e online
(MEDLINE). These strategies are presented in Table 1.
Possible RCTs in plastic surgery were identified and
selected. Trials that have not been carried out by plastic
surgeons or with the participation of at least one plastic
surgeon were excluded. One author conducted the searches
and another author performed the selection of trials, by
reading all the abstracts. After selection, the full texts of
the trials were assessed.
Two reviewers independently classified the trials
according to allocation concealment;13 disagreements were
resolved at a consensus meeting. RCTs in plastic surgery with
allocation concealment appropriately described were then
selected, and they constituted the sample of this study. For
each of these RCTs, basic data were gathered, such as journal
and year of publication and country of association.
The selected RCTs were then evaluated as to their
quality. The assessment was independently made by two
raters and cross-checked. Two validated tools were used to
assess the quality of RCTs: the Delphi List14 and the Jadad’s
quality scale15 (Table 2).
The Delphi List is a generic criteria list for quality
assessment in RCTs, which should be used alongside other
instruments.14 The Jadad’s quality scale is scored thus:
a score of one point is given for each “yes” and zero points for
each “no”. Point awards for the first two items (randomisation and double blinding) depend not only on whether the
trial is described as randomised or double blind, but also on
the appropriateness of the methods used to randomise and
blind the trial: if these methods are described and are
appropriate, one additional point is given for each item.
Conversely, if the methods used to generate a randomisation
sequence or create blinded conditions are described, but are
inappropriate, the relevant item is given zero points. Thus,
the scale produces scores from 0 to 5. A trial could be judged
as having poor quality, if it is awarded two points or less.15
The results were compared with data from the previous
study, which has assessed quality of reports of RCTs in
plastic surgery from 1966 to December 2003.12
Statistical method
The chi-square test for two independent variables was
applied to compare the time periods 1966e2003 and
2004e2008 with regard to percentile distribution of trials
among the four searched databases. The same test was
used to compare time periods (1966e2003 and 2004e2008)
with regard to distribution of the RCTs with allocation
concealment appropriately described, according to journal
where they were published, continent (country) of origin
and items of Delphi List.
The chi-square test for one variable was used to
compare 5-year periods, from 1984 to 2008, with regard to
distribution of RCTs with allocation concealment appropriately described.
Kappa statistic was used to study agreement between
the two reviewers in the assessment of trials’ allocation
concealment, in data collection for the Delphi List and in
data collection for Jadad’s quality scale. The agreement
coefficients (kw) were calculated, and significance was

3. Evolution of reports of randomised clinical trials
Table 1
Database
705
Strategies of electronic search elaborated for databases consulted.
Strategy of electronic search
LILACS, MEDLINE, (Pt randomized controlled trial or Pt controlled clinical trial or Mh Randomized Controlled
EMBASE
Trials as Topic or Clinical Trials, Randomized or Controlled Clinical Trials, Randomized or Mh Random
allocation or Randomisation or Mh Double-Blind Method or Double-Masked Study or Mh Single-Blind
Method or Single-Masked Study) and Ct humans and not (Ct animals or (Ct animals and Ct humans))
and (Ex E04.680$ or Mh Surgery, Plastic orTw cirurg$ OR Tw cirug$ OR Tw surg$ OR Tw procedure$ OR
Tw procedim$ OR Tw metodo$ OR Tw method$ OR Tw tecnic$ OR Tw technique$) and (Tw reconstru$ OR
Tw cosmetic$ OR Tw plastic$ OR Tw esthetic$ OR Tw estetic$ OR Tw aesthetic$) and (pd 2004 or pd 2005
or pd 2006 or pd 2007 or pd 2008) [Words]
CCTR
1. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$
or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$
or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778)
2. limit 1 to yr Z 2008 (145)
3. limit 2 to last 5 years (145)
4. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$
or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$
or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778)
5. limit 4 to yr Z 2004e2008 (1480)
6. limit 4 to (yr Z 2004e2008 and last 5 years) (1480)
7. ((Surgery Plastic or Plastic Surgery or (cirurg$ or cirug$ or surg$ or procedure$ or procedim$ or metodo$
or method$ or tecnic$ or technique$)) and (reconstru$ or cosmetic$ or plastic$ or esthetic$ or estetic$
or aesthetic$)).mp. [mp Z title, original title, abstract, mesh headings, heading words, keyword] (3778)
8. limit 7 to yr Z 2004 - 2008 (1480)
9. from 8 keep 1-200 (200)
10. from 8 keep 1-100 (100)
11. from 8 keep 201-400 (200)
assessed by the calculated z-values. Values of the kappa
statistic are generally interpreted as kw values below 0.40,
poor agreement; from 0.40 to 0.75, fair-to-good agreement; above 0.75, excellent agreement.16
The KolmogoroveSmirnov test was used to compare the
periods 1966e2003 and 2004e2008 with regard to percentile distribution of Jadad’s quality scale scores.
Statistical analysis was performed using Statistical
Package for Social Sciences (SPSS) version 18 (SPSS, Inc.,
Chicago, IL, USA). A p value 0.05 was considered statistically significant.
Results
The electronic search identified 3840 reports in the four
consulted databases. Table 3 presents the distribution
Table 2
Table 3
surgery.
Items of the Jadad’s quality scale.15
Yes
Was the study described as
randomized (this includes the
use of words such as randomly,
random and randomisation)?
Was the method appropriate?
Was the study described as
double blind?
Was the method appropriate?
Was there a description of
withdrawals and dropouts?
among the databases, as well as data from 1966 to 2003,12
and their statistical comparison.
One reviewer selected 223 reports, excluding the 3617
studies that clearly were not RCTs, or that have not been
carried out by plastic surgeons or with the participation of
at least one plastic surgeon. Of the 223 studies, 91 were
common to two or more databases or they repeated inside
of the same database. After examining the full text of the
132 remaining reports, the reviewer excluded 36, for the
following reasons: seven studies were not RCTs and 29
studies have not been carried out by at least one plastic
surgeon. Thus, the final selection had 96 studies.
Two reviewers independently classified the 96 selected
studies according to allocation concealment.13 The
description of allocation concealment was considered
adequate when the manoeuvre employed by the authors to
No
Database
Results of electronic search of RCTs in plastic
Trials
1966e2003
n
CCTR
EMBASE
LILACS
MEDLINE
635
2354
127
1811
Total
4927
c Z 1536.2, p 0.000.
2
2004e2008
%
12.9
47.8
2.6
36.7
100
n
1480
500
8
1852
3840
%
38.5
13.0
0.2
48.2
100

4. 706
D.F. Veiga et al.
assure that group allocation cannot be influenced by the
investigators or the study participants was explicit in the
report. The agreement coefficient (kw) between the two
reviewers was 0.70 (z Z 9.82, p 0.000). After a consensus
meeting, they had 28 studies that were RCTs in plastic
surgery, with allocation concealment properly described.
Table 4 presents the distribution of these RCTs published
over time periods of 5 years, comparing the results of the
present study with data from 1966 to 2003.12 The first time
period presented was 1984e1988 because the first RCT in
plastic surgery with allocation concealment appropriately
described that was found was published in 1984.17 There was
a significant increase in the number of trials with allocation
concealment properly described along the time (c2 Z 22.98;
p 0.000).
The distribution of these RCTs publications in three
major plastic surgery journals (Plastic and Reconstructive
Surgery; Journal of Plastic, Reconstructive Aesthetic
Surgery; and Annals of Plastic Surgery) is pointed out in
Table 5. Europe and North America published over 80% of
the RCTs with allocation concealment properly described,
and there was no statistical difference as compared with
the time period 1966e2003 (Table 6).12
The agreement coefficient between the two independent
raters in the assessment of the 28 RCTs by the Delphi List14
was 0.46 (z Z 7.24, p 0.000). The assessment by the Delphi List,14 after the consensus meeting, is shown in Table 7,
which also presents data from 1966 to 2003.12 A significant
improvement, compared with 1966e2003, was noted only for
the item ‘similarity of the groups at baseline regarding the
most important prognostic factors’ (c2 Z 18.53, p 0.000).
The agreement coefficient between the raters in the
assessment of the 28 RCTs by Jadad’s quality scale was 0.72
(z Z 8.57, p 0.000). After the consensus meeting, the
median Jadad score was 3 (mean 3.7). Table 8 shows the
distribution of RCTs, according to Jadad score,15 published
from 1966 to 2003 and 2004 to 2008.12 There was a significant improvement in Jadad scores during 2004e2008
(c2 Z 12.18, p Z 0.002).
Discussion
Decisions makers in health care are increasingly seeking
high-quality scientific evidence to support clinical and
Table 4 Distribution of the RCTs with allocation concealment appropriately described according to the year of
publication.
Year
Trials
n
1984e1988
1989e1993
1994e1998
1999e2003
2004e2008
6
8
8
12
28
Total
62
c Z 22.98, p 0.000.
2
%
9.7
12.9
12.9
19.3
45.2
100
Table 5 Distribution of the RCTs with allocation concealment appropriately described according to the journal where
they were published.
Journal
Trials
1966e2003
2004e2008
n
n
Plast Reconstr Surg
J Plast Reconstr Aesth Surg
Ann Plast Surg
Other
13
10
2
9
Total
34
%
38.2
29.4
5.9
26.5
100
13
2
1
12
28
%
46.4
7.1
3.6
42.9
100
c Z 5.6, p Z 0.14.
2
health policy choices.16,18 RCTs provide the highest level of
evidence in health-care interventions.14,15,19 However, the
nature of surgical practice is such that evidence-based
medicine is less popular in surgery than in the medical
specialities.3,4,8 Furthermore, when RCTs have been conducted in the field of plastic surgery, their validity is many
times in question because of poor methodology.4
Limitations of RCT research in plastic surgery, including
technical, practical and ethical issues are intrinsic to our
speciality and cannot readily be changed.3 Despite the
difficulty in performing RCTs in plastic surgery, trials that
are performed need higher methodologic and reporting
standards. Instituting higher standards may improve the
impact of trials and make them more influential in plastic
surgery practice.2,8,20
Our study has limitations that deserve mention. They
include performing just electronic searches, not associated
with hand searches, and only evaluating quality of RCTs with
allocation concealment appropriately described, thus,
eventually excluding RCTs well designed and well conducted
but which failed in describing allocation concealment.
Another limitation is that strategies of search included
neither hand surgery nor any other specific surgical field,
such as cleft or maxillofacial surgery. The inclusion of terms
such these in the strategies of electronic search could have
greatly increased the number of RCTs reported. However,
the main point is that we were limited to the methodology
applied to the previous study;12 otherwise, we could not
compare the results.
Compared with 1966e2003, we observed a statistically
significant difference in the distribution of trials among
databases. Particularly, there was an important increase in
the output of CCTR. We speculate that this statistically
significant increase could be attributed to the recent
inclusion of Cochrane Library in the databases of the
Institute for Scientific Information (ISI). We noted also
a statistically significant decrease in the number of RCTs
recovered from EMBASE.
Our analysis of continent (country) of origin revealed
that Europe has published the majority of RCTs (50%), followed by North America (32%). The fact that the majority of
RCTs are published by researchers from Europe and North
America has already been demonstrated.2,7,21,22 Despite
the fact that the majority of RCTs with allocation
concealment appropriately described was conducted by

5. Evolution of reports of randomised clinical trials
Table 6
707
Distribution of the RCTs with allocation concealment properly described according to continent of origin.
Continent (country)
Trials
1966e2003
n
2004e2008
%
n
%
Europe (Denmark, Finland, France, Germany, Italy,
Netherlands, Norway, Sweden, United Kingdon)
North America (Canada, Puerto Rico, United States)
South America (Brazil, Chile)
Asia (India, Japan)
Oceania (Australia)
24
70.6
14
50.0
8
e
1
1
23.5
e
2.9
2.9
9
3
2
e
32.1
10.7
7.1
e
Total
34
100
28
100
c Z 6.5, p Z 0.17.
2
European researchers, most of them were published in
Plastic and Reconstructive Surgery, followed by Journal of
Plastic, Reconstructive Aesthetic Surgery. This fact has
also been demonstrated previously.2,12,18
Despite the visible difference for the period from 2004
to 2008, there was no statistical difference in the number
of publications of RCTs with allocation concealment
appropriately described among the plastic surgery journals.
Unless more RCTs will be published in plastic surgery journals, we will never be able to determine statistical significance for these data.
Table 7
On assessing the quality of reports of RCTs in plastic
surgery published from 1966 to 2003, we concluded that their
quality was low (mean Jadad score 2.4).12 Taghinia et al.
critically assessed the quality of RCTs published from 1986 to
2006 in three major plastic surgery journals. They used the
Jadad criteria, besides other parameters such as allocation
concealment, appropriate blinding and intention-to-treat
analysis. The mean Jadad score in their study was similar:
2.3.8 In the present study, the mean Jadad score was 3.7,
clearly demonstrating the increase in quality of reports of
RCTs with adequate allocation concealment. When the
Quality assessment by Delphi List14 after co nsensus meeting.
1966-2003
2004-2008
Chi-square
Yes
NS Z non significant.
Yes
No
n (%)
Treatment allocation:
Was a method of
randomisation
performed?
Was the treatment
allocation concealed?
Were the groups similar
at baseline regarding
the most important
prognostic indicators?
Were the eligibility
criteria specified?
Was the outcome
assessor blinded?
Was the care provider
blinded?
Was the patient blinded?
Were point estimates
and measures of
variability presented
for the primary
outcome measures?
Did the analysis include
an intention-to-treat
analysis?
No
n (%)
n (%)
n (%)
34(100.0)
e
28(100.0)
e
e
34(100.0)
e
28(100.0)
e
e
14(41.2)
20(58.8)
27(96.4)
1(3.6)
c2 Z 18.53***p Z 0.000
17(50.0)
17(50.0)
19(67.9)
9(32.1)
NS
17(50.0)
17(50.0)
18(64.3)
10(35.7)
NS
11(32.4)
23(67.6)
9(32.1)
19(67.9)
NS
20(58.8)
15(44.1)
14(41.2)
19(55.9)
14(50.0)
19(67.9)
14(50.0)
9(32.1)
NS
NS
13(38.2)
21(61.8)
9(32.1)
19(67.9)
NS

6. 708
D.F. Veiga et al.
Table 8 Scores of the Jadad’s quality scale15 after consensus meeting.
progressively introducing our speciality to a higher evidencelevel research.
Scores
Conflict of interest statement
Trials
1966-2003
n
0
1
2
3
4
5
4
1
15
7
4
3
Total
34
2004-2008
%
11.8
2.9
44.1
20.6
11.8
8.8
100
n
%
e
e
4
11
2
11
e
e
14.2
39.3
7.1
39.3
28
100
c Z 12.18, p Z 0.002.
2
Delphi List was applied, however, we had a statistically
significant improvement only in the item ‘similarity of groups
at baseline regarding prognostic indicators’.
Of the multiple published scales used to evaluate
methodologic quality, the Jadad score is the most commonly used.8 It has been validated for this purpose using
well-established procedures.8,15 The scale was originally
developed using studies from the pain literature, and it has
some limitations when applied to surgical trials. A major
one is that 40% of the total score is based on the definition
of double blinding, which is difficult to achieve in surgical
trials.7 Thus, Jadad recommends that the quality scale
should be used alongside other instruments.5 Clark et al.,
assessing the reliability of the Jadad scale, saw a low
interobserver agreement.23 However, in the present study,
the inter-rater agreement coefficient was good (0.72).
Recent studies demonstrated that the plastic surgical
community has recognised the necessity of improving the
evidence level of plastic surgery research, reflected by the
continuous increase in publications of RCTs.2,7,18,21
In the present study, besides the statistically significant
increase in the number of RCTs in plastic surgery published
over the last years, we observed a statistically significant
increase in the quality scores of these RCTs, particularly
with regard to randomisation methods and blinding. Plastic
surgeons were also successful in appropriately describing
withdrawals and dropouts and similarity of groups at
baseline. The quality of reports of RCTs in plastic surgery,
however, still needs improvement.8 There are many other
issues, such as including an intention-to-treat analysis,
which must be improved.
It was encouraging to verify that 86% of the RCTs with
allocation concealment appropriately described were
considered of high quality (Jadad’s score up to 3). Further,
46% of these high-quality RCTs reached the highest Jadad
score of 5.24e34
However, as compared with other specialities, RCTs in
plastic surgery still are fewer and of lower impact.1,8,35,36 We
agree with McCarthy et al. when they affirm that “as plastic
surgeons, we can assume an increased leadership role in
producing impartial evidence on the efficacy of our surgical
interventions.”17 We believe that our results highlight the
recognition, by plastic surgeons, of the importance of
The authors have no conflicts of interest, no financial or
personal relationships with other people or organisations
that could inappropriately influence this work.
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