Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
Barnes et al. BMC Medicine
Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial
Caroline Barnes 0 2
Isabelle Boutron 0 1 2 3
Bruno Giraudeau 2 6
Raphael Porcher 0 1 2 3
Douglas G Altman 5
Philippe Ravaud 0 1 2 3 4
0 Paris Descartes University , Paris , France
1 Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Hôpital Hôtel Dieu , Aile A2 1er étage 1, Place du parvis Notre Dame, 75181 Paris, Cedex 4 , France
2 INSERM, UMR 1153, Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité - (CRESS), METHODS team , Paris , France
3 Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Hôpital Hôtel Dieu , Aile A2 1er étage 1, Place du parvis Notre Dame, 75181 Paris, Cedex 4 , France
4 Department of Epidemiology, Columbia University Mailman School of Public Health , New York, NY , USA
5 Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford , Oxford , UK
6 INSERM CIC 1415, Université François-Rabelais de Tours; CHRU de Tours , Tours , France
Background: Incomplete reporting is a frequent waste in research. Our aim was to evaluate the impact of a writing aid tool (WAT) based on the CONSORT statement and its extension for non-pharmacologic treatments on the completeness of reporting of randomized controlled trials (RCTs). Methods: We performed a 'split-manuscript' RCT with blinded outcome assessment. Participants were masters and doctoral students in public health. They were asked to write, over a 4-hour period, the methods section of a manuscript based on a real RCT protocol, with a different protocol provided to each participant. Methods sections were divided into six different domains: 'trial design', 'randomization', 'blinding', 'participants', 'interventions', and 'outcomes'. Participants had to draft all six domains with access to the WAT for a random three of six domains. The random sequence was computer-generated and concealed. For each domain, the WAT comprised reminders of the corresponding CONSORT item(s), bullet points detailing all the key elements to be reported, and examples of good reporting. The control intervention consisted of no reminders. The primary outcome was the mean global score for completeness of reporting (scale 0-10) for all domains written with or without the WAT. Results: Forty-one participants wrote 41 different manuscripts of RCT methods sections, corresponding to 246 domains (six for each of the 41 protocols). All domains were analyzed. For the primary outcome, the mean (SD) global score for completeness of reporting was higher with than without use of the WAT: 7.1 (1.2) versus 5.0 (1.6), with a mean (95 % CI) difference 2.1 (1.5-2.7; P <0.01). Completeness of reporting was significantly higher with the WAT for all domains except for blinding and outcomes. Conclusion: Use of the WAT could improve the completeness of manuscripts reporting the results of RCTs. Trial registration: Clinicaltrials.gov (http://clinicaltrials.gov NCT02127567, registration date first received April 29, 2014)
Clinical epidemiology; CONSORT statement; Randomized controlled trial; Reporting guidelines; Transparency
Inadequate reporting is a frequent cause of waste in
research [1, 2]. To overcome this issue, the CONSORT
Statement , an evidence-based, minimum set of
recommendations for reporting randomized controlled
trials (RCTs), was developed, along with extensions for
reporting specific designs (e.g. cluster , non-inferiority
), data (e.g. harms ), and interventions
(nonpharmacologic treatments ). The CONSORT
guidelines have received support from the World Association
of Medical Editors, the Council of Science Editors, and the
International Committee of Medical Journal Editors.
According to the CONSORT website , currently 585
journals worldwide endorse CONSORT. Most journals
include recommendations to follow the main CONSORT
statement in their instructions to authors and some have
specific policies to enforce the use of the CONSORT
guidelines at the submission or revision stage of a
However, the adherence of authors to these guidelines
is low and the quality of reporting remains insufficient
[9–21]. For example, the method of randomization was
described in only 25 % of published RCTs [10, 15, 22],
and more than 30 % of reports did not provide sufficient
details to allow replication of the treatment evaluated in
the trial in clinical practice [11, 23].
Several barriers can explain the lack of adherence to
the CONSORT guidelines [1, 24–27]. Our hypothesis is
that the strategy currently used to implement the
reporting guidelines, such as the CONSORT Statement and its
extensions, could be improved. First, the timing of
implementation of CONSORT is late in the process. In
fact, most active strategies used to improve the quality
of reporting are implemented by editors and consist of
asking authors to submit the CONSORT checklist at the
submission or acceptance stage [9, 20]. Modifying a
manuscript ready for submission is probably more
difficult than writing the first draft of the manuscript
according to the guidelines. Implementation at an earlier
stage when writing the manuscript, instead of the
submission or revision stages, could be more efficient.
Second, the CONSORT Statement and its extension
are disseminated in two formats: (1) the CONSORT
Statement (a checklist and flow diagram) and (2) the
CONSORT “Explanation and Elaboration” document
[3, 7]. The checklist is probably not sufficient for some
authors to adequately understand what should be
reported. For example, to report the item dedicated to the
intervention “Description of the different components of
the interventions [..]” authors reporting a surgical trial
may benefit from more support to understand that they
should report, in addition to the surgical procedure, all
of the following information: details on preoperative
care, postoperative care, and anesthesia management.
The Explanation and Elaboration documents are meant
to help authors understand the checklist. However, these
documents are very long (more than 30 pages) and they
combine explanations about why the item should be
reported, how the item is reported in the literature, what
should be reported, and examples of adequate reporting.
Consequently, the important information is buried in
the manuscript. The use of a template shell with a clear
and explicit reminder of what should be reported when
authors are writing their manuscript could be useful to
increase adherence to the guidelines.
Finally, authors may need more support to adequately
combine the different extensions of the CONSORT
statement. In fact, to adequately report a cluster RCT
evaluating a rehabilitation program, authors must rely on
three checklists and three Elaboration and Explanation
documents for the main CONSORT, the extension for
cluster trials, and the extension for non-pharmacologic
treatments. Up to now, no support has been developed to
help authors successfully adhere to reporting guidelines at
the writing stage of the manuscript.
An online writing aid tool that combines the different
extensions of the CONSORT Statement and provides
appropriate explanations with examples of adequate
reporting would be a more efficient way to implement the
CONSORT statements and thus improve the quality of
reporting. We developed a writing aid tool based on the
CONSORT guidelines and its extension for
nonpharmacologic treatments to help authors when writing a
report of a RCT. We evaluated the impact of this tool on
the completeness of reporting of two-arm parallel-group
RCTs evaluating pharmacologic and non-pharmacologic
We performed a ‘split-manuscript’ RCT with blinded
outcome assessment. The methods section of each
manuscript was divided into six different domains: ‘trial design’,
‘randomization’, ‘blinding’, ‘participants’, ‘interventions’, and
‘outcomes’. Each participant was randomly allocated to a
different real RCT protocol. Participants had to write the
six domains of the methods section of the manuscript for
the protocol they received over a 4-hour period. They had
access to the tool for a random three of the six domains.
Thus, the unit of randomization was the domain,
embedded within the manuscript (Fig. 1).
Authorization by the CNIL (“Commission Nationale de
l’Informatique et des Libertés”; file number 1753007) whose
remit is to protect participants’ personal data and the
institutional review board of INSERM ethics committee
(IRB 00003888) was obtained and the study protocol was
registered at ClinicalTrials.gov (http://clinicaltrials.gov
Fig. 1 Schema of the study design
Informed consent was obtained from all participants.
The consent was obtained electronically. All parts of the
trial were conducted in Paris.
The randomization sequence was computer-generated
with the use of SAS 9.2. For each participant-manuscript,
three domains were allocated to the ‘writing aid tool’
group and the three remaining domains were allocated to
the ‘usual writing’ group. Allowing for 20 possible
combinations of domains (i.e. three of six domains with the tool
and three without), randomization was performed with
permuted blocks of 20.
Only the independent statistician and the computer
programmer who developed the online writing aid tool and
the website had access to the randomization list. The
statistician who generated the list (BG) provided the list
to the programmer, who uploaded it on the study’s
secure website. The list was not available to the
researchers who enrolled the participants and were present
at the various study sessions (CB, IB).
The sequence was concealed by a computer interface.
Study participants were masters or doctoral students in
the field of public health and medical research who were
based in Paris and who were affiliated with Paris
Descartes University, Pierre and Marie Curie University,
and Paris Diderot University, or the Mailman School of
Public Health of Columbia University, in New York.
An e-mail advertisement was sent to students to invite
them to participate in a writing session. Participants were
not informed of the study in the email advertisement.
Before obtaining their consent, participants attended a small
informational session with a PowerPoint presentation
describing the writing task to perform. Participants were
instructed to complete six sections of a manuscript
describing the study protocol they were provided and that
they would have assistance for three sections and no
assistance for three sections, although they were not
instructed as to which sections. They were informed that
this design had a pedagogical purpose as they could see
how useful it was to have the writing aid tool and use
reporting guidelines when writing the first draft of a
manuscript. They were instructed that we would use their
results to evaluate the impact of the tool. Before
beginning the exercise, participants provided their consent
Selection of protocols
We retrieved all protocols of RCTs published between
January 1, 2013, and March 28, 2014, in the New England
Journal of Medicine or the Journal of Clinical Oncology.
We chose these journals because they provide access to
the protocol for all the RCTs they publish.
One researcher (CB) searched MEDLINE via PubMed
(search strategy is reported in Additional file 1) and
screened all titles and abstracts retrieved to select all
reports of two-arm parallel-group RCTs. All available
protocols published in English were retrieved for all
identified reports of RCTs. Then, we constituted a
sample of protocols reporting various pharmacologic
interventions and non-pharmacologic treatments (surgery,
implantable devices, rehabilitation, education, etc.; see
sample size below).
Objective of the tool
The writing aid tool based on CONSORT was
developed to provide guidance to authors when writing a
manuscript of a RCT evaluating pharmacologic
treatment or non-pharmacologic treatment. The tool was
individualized according to the type of treatment
evaluated (drug, surgery, participative interventions such as
Content of the tool
The content of the tool was based on the checklist and the
Explanation and Elaboration document for CONSORT
2010  and the checklists and the Explanation and
Elaboration documents of the CONSORT extension for
nonpharmacologic treatment . For each domain, the tool
comprised the corresponding CONSORT checklist item(s),
bullet points with the key elements that need to be reported
extracted from the Explanation and Elaboration document
of the CONSORT 2010, and non-pharmacologic treatment
extension, as well as (an) example(s) of good reporting. For
the domain dedicated to the intervention, the bullet points
and examples of adequate reporting were individualized
according to the treatment evaluated (i.e. medication or
treatment strategy; surgical procedures or devices; or
participative interventions such as rehabilitation, education,
behavioral treatment, or psychotherapy). For example,
when the experimental treatment was a surgical procedure,
the bullet points with the key elements that needed to be
reported were specific to surgical procedures (e.g.
anesthesia, preoperative care, postoperative care) and the
examples of adequate reporting concerned surgical trials.
An example is included in Fig. 2. The entire tool is
available at  (enter any username) and in Additional file 2.
Format of the tool
For each domain, the online writing aid tool consisted of
a single or several large text boxes in which the
participants could write the corresponding part of the methods
section. Above each text box was a reminder of the
information that should be reported. This reminder
consisted of the related CONSORT item followed by the
statement “Please describe” and bullet points with all the
information that needed to be reported.
According to the domain and the complexity of the
CONSORT item, the tool could contain one or several
text boxes. For example, two boxes were dedicated to
the domain trial design: one to describe the trial design
and one to report important changes to methods after
the trial commencements with reasons.
For each domain, the intervention consisted of a large
text box in which the participant could write this part of
the methods section. They did not have the CONSORT
Interventions were administered in the context of a
practice writing session. Participants were asked to write
six sections of a manuscript based on a protocol they
were provided describing an RCT over a 4-hour period.
Each participant was provided a protocol randomly
selected in our sample of protocol in both electronic
copy and paper copies. Two study monitors (CB and IB)
supervised these writing sessions after providing a brief
explanation of the task to be performed. Participants
were aware that they would have access to the writing
aid tool for some of the sections. They were not allowed
to use any materials. Participants were told that all data
would be anonymous and confidential.
For both the experimental and control interventions,
participants were instructed to indicate any important or
necessary information they would have wished to report
that was not available in the provided study protocol
The primary outcome was the mean global score for
completeness of reporting (scale 0–10) for all domains
written with or without the writing aid tool.
For each domain, within each protocol selected, we
prespecified a series of keywords that should be reported. For
example, in a study using a 1:1 randomization with a
computer generated randomization list with blocks of four and
Fig. 2 Example of the experimental writing tool
stratification on the study site, the following key words
were pre-specified ‘Computer generated’, ‘blocks of 4’, ‘1:1’,
‘stratification on site’. We also pre-specified a weight for
For each protocol, completeness of reporting was
determined by the presence or absence of the pre-specified
keywords and their respective pre-specified weights. If
the information was not available in the protocol but
was described by the writer as missing, it was rated as
Because the number of keywords varied among the
domains by the domain type, the type of treatment
evaluated, and the context of the protocol, we standardized
the scores for each domain on a scale of 0–10. An
example for the scoring system for completeness of
reporting is in Additional file 3. Therefore, we obtained
six scores for completeness of reporting for each
participant-protocol pair, three associated with domains written
with the writing tool and three with domains written
without the tool. These scores were the unit of analysis (cf.
Statistical methods section), and the statistical analysis
allowed for estimating mean scores for completeness of
reporting with and without the writing tool.
Two independent researchers blinded to intervention
assignment and to the writer identity assessed the
presence of these keywords for all protocols by domain. To
maintain blinding, outcome assessors measured the
outcome for each of the six domains separately, all text
appearing in a different random order in the same
format (with the same font and text size). After the
researchers had assessed all the domains, they met to
resolve any disagreements by consensus.
Secondary outcomes were (1) the scores for completeness
of reporting for each individual domain (trial design,
randomization, blinding, participants, interventions, and
outcomes of participant reports) and (2) the mean score
for completeness of reporting of pre-specified essential
elements of each domain (Additional file 4).
We aimed to compare the mean global score for
completeness of reporting scores (scale 0–10) for all domains
of the manuscript written by the participants with and
without the tool to the methods sections of the
published articles. For this purpose, we retrieved all the
published reports corresponding to the selected
protocols and their related appendices. The same two
outcome assessors were asked to read the methods
section of the published articles as well as all appendices
referenced in the article and evaluate the presence or
absence of the same pre-determined keywords. They
were not blinded to the journal or authors’ names.
Sample size calculation
The sample size was calculated using the same method
as for a cluster randomized cross-over trial . We
assumed a mean score of 4 (0–10 scale) for the domains
written without the tool (i.e. control group) and
considered a standard deviation (SD) of 4 (which is a rather
conservative assumption). Our hypothesis was that the
mean score would be 6 for the domains written with the
tool (i.e. experimental group). We specified an intraclass
correlation coefficient of 0.8 (i.e. the correlation between
scores of reports of two domains with the same
interventional assignment, written by the same student). Such
a conservative value was motivated by the nature of the
design: two domains within a cluster are actually two
domains completed by the same participant. We
hypothesized that the intraclass correlation coefficient was half
the intraclass correlation (0.4), and we considered a
twosided 5 % Type I error and a nominal power of 90 %.
The inflation factor then was 1.4, the required number
of observations (i.e. domains) per group 120, and the
required number of participants 40.
Descriptive statistics were reported as number and
percentage for categorical variables and median and
interquartile range (IQR) for quantitative variables. The
statistical unit of analysis was the section, which was
embedded in the couple participant-protocol (since each
participant had a different protocol, there is no
distinction between participants and protocols). Therefore, we
had six observations for each participant: three in the
experimental group in which the writing aid tool was
used, and three in the control group. For the main
analysis, sections were considered exchangeable (i.e. the
intervention effect was assumed to be the same whatever
the domain of the section). Then, such a data-structure
is the same as the classical data structure encountered in
split-mouth designs or cluster randomized cross-over
trials. Therefore, data were analyzed using a mixed
model, which included a fixed intervention effect, a
random participant effect, and a random participant-group
Furthermore, because the hypothesis of a common
intervention effect to all six domains was strong, we
completed the primary analysis with a series of six
independent substudies (i.e. one for each domain). For each
of these substudies, we had only one statistical unit
associated with each couple participant-protocol, which
implies independence between the statistical units.
Therefore, we performed classical Student t-tests. To
evaluate the robustness of our results, we performed a
sensitivity analysis with simulations of different possible
weighting systems (Additional file 5).
For the ancillary study, we also considered the
domain’s score for completeness of reporting as the unit of
analysis. For each domain, within each protocol, we had
one score for the participant of the present study and
another for the authors of the published report. These
paired data were split by whether the participant used
the writing tool or not. Differences in paired scores were
then analyzed in the framework of mixed models with
no other fixed effect than an intercept and with the
protocol as a random effect.
Forty-one masters and doctoral students participated in
this study in May 2014. The flow diagram is shown in
Fig. 3. As shown in Table 1, participants had a median
age of 29 (IQR, 26–33) years. Seven participants (17 %)
reported having had experience with writing about
RCTs. Almost all participants (n = 38 (93 %)) reported
having previously been taught about RCTs and 24 (58 %)
reported being familiar with reporting guidelines.
We identified 158 of 308 citations screened, from which
we sampled 41 protocols (one for each participant). A
flowchart of the method for selecting protocols is shown
in Additional file 1, and Table 1 describes the
characteristics of protocols. Overall, 20 protocols reported an RCT
Fig. 3 Flow diagram of participants and domain randomization
evaluating pharmacologic treatments (oral drugs,
intravenous/parenteral treatments, intramuscular treatments,
subcutaneous treatments, intradermal, treatment strategies)
and 17 non-pharmacologic treatments (surgery or
implantable device, participative interventions, radiation).
The mean global score for completeness of reporting
(scale 0–10) for all domains was higher with than
without the use of the writing aid tool: mean (SD) 7.1 (1.2)
versus 5.0 (1.6), for a mean difference (95 % CI) of 2.1
(1.5–2.7; P <0.0001; Table 2).
Secondary outcomes are reported in Table 2. The
completeness of reporting (score 0–10) was significantly
higher with than without the writing aid tool for all
domains except blinding and outcomes. The mean difference
in scores (95 % CI) for each domain were for trial design,
5.4 (4.1–6.7), P <0.01; randomization, 3.8 (1.1–4.4),
P <0.01; blinding, 0.7 (–0.7 to 2.0), P = 0.50; participants,
2.2 (0.8–3.6), P <0.01; interventions, 1.8 (0.7–2.9); P <0.01;
and outcomes, –0.3 (–2.0 to 1.3), P = 0.43.
The completeness of reporting of essential elements
was higher with than without the writing aid tool, with a
mean difference (95 % CI) of 1.4 (0.5–2.3; P = 0.002).
On sensitivity analyses, the results were robust to the
choice of the weight (Additional file 4).
Table 1 Participant and protocol characteristics
Education (doctoral students)
Frequency reading RCTs
More than once a year
Experience writing RCTs
Previously involved in RCTs
Familiar with guidelines
Comfortable with English
RCT Randomized controlled trial
N = 41 (%)
N = 41 (%)
Results of the ancillary study are shown in Table 3.
Overall, the global completeness of reporting scores for
the sections written without the writing aid tool did not
significantly differ from those of the published
manuscripts, with a mean difference of –0.48 (–1.07 to 0.11).
In contrast, the global score for completeness of
reporting scores for the sections written with the writing aid
tool were higher than those of the publications, with a
mean difference of +1.73 (1.10–2.37), P <0.001.
We developed a writing aid tool to support the use of
the CONSORT statement. We performed a
proof-ofGlobal score for completeness of reporting for
all domains (primary outcome)
Score for completeness of reporting for
Completeness of reporting score by individual domain
Table 2 Completeness of reporting domains of methods sections with and without the writing aid tool
Writing aid tool scores (0–10) No writing aid tool scores (0–10) Mean difference P value
Mean (SD) Mean (SD) (95 % CI)
7.1 (1.2) 5.0 (1.6) 2.1 (1.5–2.7) <0.001*
0.7 (–0.7 to 2.0) 0.44**
–0.3 (–2.0 to 1.3) 0.78**
No writing aid tool
concept RCT including masters and doctoral students to
evaluate the impact of this tool. Our results revealed a
large effect of the writing tool on the completeness of
reporting scores, with a mean difference in scores of 2.1
on a 0–10 scale. Completeness of reporting was
significantly improved for all six domains of the methods
section except for blinding and outcomes. However, for
these domains, the scores without the use of the tool
were relatively high and the opportunity for
improvement was consequently limited. The ancillary study
showed that the manuscripts written with the tool in a
limited time (4 hours) had higher global score of
completeness of reporting than the actual reports, which
were published in high-impact-factor journals.
Our study has several strengths. First, it is a
proof-ofconcept study that used a strong design, an RCT, to
evaluate the impact of this tool. We performed an RCT using a
split-manuscript design. Second, this study explored the
impact of the writing tool using real protocols of
published RCTs. Third, the protocols selected evaluated a
wide variety of different interventions exploring
pharmacologic- and non-pharmacologic-based treatments
(surgical and non-surgical) as well as various treatment
strategies (treatment timing, target outcomes, etc.). The
quality of reporting of the selected protocols varied.
However, our study had some limitations. First, the
participants were masters and doctoral students and the
writing session lasted only 4 hours, which is not representative
of typical authors and the typical context of writing a report
of an RCT. However, the global score for completeness of
reporting was not lower than that for the published report.
In contrast, this comparison confirmed a large effect of the
writing tool. Second, the writing aid tool considered only
six domains of the methods section of a manuscript using
the CONSORT 2010 statement and the extension for
nonpharmacologic treatments. We did not explore the impact
of the implementation of all items of the CONSORT
statement and all its extensions on the completeness of
reporting. Third, there is an important degree of relatedness
between the experimental intervention (the writing aid
tool) and the evaluation. However, the primary outcome we
used (i.e. the completeness of reporting according to the
CONSORT statement and CONSORT extension for
nonpharmacologic treatments) is the outcome usually used to
evaluate the adherence to reporting guidelines and seemed
the most relevant outcome. Finally, we lack a validated
outcome measure to appropriately evaluate the quality of
reporting in various contexts. However, the sensitivity
analysis exploring the impact of a variation of the weight used
showed that our results were robust.
Table 3 Ancillary study, mean global score for completeness of reporting (scale 0–10) for all domains written with or without the
writing aid tool compared to the published report
–0.48 (–1.07 to 0.11)
Previous studies have explored the impact of other
types of interventions on compliance with the
CONSORT guidelines when reporting RCTs. These studies
have explored the impact of the publication of the main
CONSORT guidelines and the CONSORT extensions
studying reporting before and after  and over time
(using a time series analysis) , journal endorsement
of CONSORT, and implementation by a journal (i.e.
requiring writers to submit a completed checklist
indicating where the information is reported in the
manuscript) [18, 31]. Hopewell et al.  showed that an
active policy to enforce the CONSORT guidelines for
abstracts led to an immediate increase in the completeness
of reporting. Finally, the results of the ancillary study need
to be interpreted with caution. In fact, we did not evaluate
the readability of each section. Some sections written with
the tool could be more complete but also more difficult to
read. Furthermore, outcome assessors were not blinded.
In this study, we proposed a new approach to improve
the reporting of RCT results and assist with the
successful implementation of the CONSORT statement. In fact,
most of the initiatives previously proposed to improve
implementation occur after the manuscript has been
written. With this writing aid tool, we aimed (1) to guide
writers to use the CONSORT guidelines and (2) to
oblige writers to address each item of the CONSORT
guidelines while writing the first draft of their
manuscript. This study has important implications for
authors, editors, and researchers. It demonstrates that a
writing aid tool can improve the completeness of
reporting and that we need to rethink the strategies used to
implement CONSORT. The tool needs to be expanded
to include all CONSORT items and incorporate all
extensions. The tool is freely available on the web 
and in Additional file 2.
This study demonstrates that the use of a writing aid
tool improves the completeness of reporting the results
of RCTs. Our results indicate new opportunities to
improve the quality of reporting research.
Additional file 1: Selection of protocols. (DOCX 278 kb)
Additional file 2: The CONSORT-based writing tool. (DOCX 144 kb)
Additional file 3: The CONSORT-based writing tool. (DOCX 19 kb)
Additional file 4: Weights for the scoring system for the completeness
of reporting essential items according to intervention type. (DOCX 18 kb)
Additional file 5: Sensitivity analyses. (DOCX 257 kb)
Philippe Ravaud is the director of the French EQUATOR (Enhancing the
QUAlity and Transparency Of health Research) Centre and member of the
EQUATOR Network Steering Group. Isabelle Boutron is the deputy director of
the French EQUATOR Centre and academic editor for BMC Medical Research
Methods, PLoS Medicine, PLoS ONE, and senior editor for Trials. Douglas
Altman is chair of the EQUATOR Network Steering Group, director of the UK
EQUATOR Centre and one of the Editors-in-Chief for Trials . This study was
performed within the CONSORT (Consolidated Standards of Reporting Trials)
Partnership. The other authors declare that they have no competing interests.
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