A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)
Identifieur interne : 003015 ( Pmc/Corpus ); précédent : 003014; suivant : 003016A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)
Auteurs : Raphael Freitas De Souza ; Carolina De Andrade Lima Chaves ; Carolina De Andrade Lima Chaves ; Carolina De Andrade Lima Chaves ; Mona Nasser ; Zbys FedorowiczSource :
- Journal of Applied Oral Science [ 1678-7757 ] ; 2010.
Abstract
Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports.
The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports.
Electronic versions of six Brazilian dental Journals indexed in SciELO were
handsearched at
The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-totreat analysis or any similar procedure.
The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement.
Url:
DOI: 10.1590/S1678-77572010000200002
PubMed: 20485919
PubMed Central: 5349744
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PMC:5349744Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A quantitative and qualitative evaluation of reports of clinical trials
published in six Brazilian dental journals indexed in the Scientific Electronic
Library Online (SciELO)</title><author><name sortKey="De Souza, Raphael Freitas" sort="De Souza, Raphael Freitas" uniqKey="De Souza R" first="Raphael Freitas" last="De Souza">Raphael Freitas De Souza</name><affiliation><nlm:aff id="aff01"> DDS, PhD, Professor, Department of Dental Materials and Prosthodontics, Ribeirão Preto Dental School, University of São Paulo, Ribeirão Preto, SP, Brazil, and Visiting Professor, Faculty of Dentistry, McGill University, Montréal, QC, Canada.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Nasser, Mona" sort="Nasser, Mona" uniqKey="Nasser M" first="Mona" last="Nasser">Mona Nasser</name><affiliation><nlm:aff id="aff03"> DDS, Researcher, Department of Health Information, Institute for Quality and Efficiency in Health Care, Cologne, Germany.</nlm:aff></affiliation></author><author><name sortKey="Fedorowicz, Zbys" sort="Fedorowicz, Zbys" uniqKey="Fedorowicz Z" first="Zbys" last="Fedorowicz">Zbys Fedorowicz</name><affiliation><nlm:aff id="aff04"> MSc DPH, BDS, LDS RCS (Eng), Director, The Bahrain Branch of the UK Cochrane Centre, The Cochrane Collaboration, Awali, Bahrain.</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">20485919</idno><idno type="pmc">5349744</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5349744</idno><idno type="RBID">PMC:5349744</idno><idno type="doi">10.1590/S1678-77572010000200002</idno><date when="2010">2010</date><idno type="wicri:Area/Pmc/Corpus">003015</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">003015</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A quantitative and qualitative evaluation of reports of clinical trials
published in six Brazilian dental journals indexed in the Scientific Electronic
Library Online (SciELO)</title><author><name sortKey="De Souza, Raphael Freitas" sort="De Souza, Raphael Freitas" uniqKey="De Souza R" first="Raphael Freitas" last="De Souza">Raphael Freitas De Souza</name><affiliation><nlm:aff id="aff01"> DDS, PhD, Professor, Department of Dental Materials and Prosthodontics, Ribeirão Preto Dental School, University of São Paulo, Ribeirão Preto, SP, Brazil, and Visiting Professor, Faculty of Dentistry, McGill University, Montréal, QC, Canada.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Chaves, Carolina De Andrade Lima" sort="Chaves, Carolina De Andrade Lima" uniqKey="Chaves C" first="Carolina De Andrade Lima" last="Chaves">Carolina De Andrade Lima Chaves</name><affiliation><nlm:aff id="aff02"> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</nlm:aff></affiliation></author><author><name sortKey="Nasser, Mona" sort="Nasser, Mona" uniqKey="Nasser M" first="Mona" last="Nasser">Mona Nasser</name><affiliation><nlm:aff id="aff03"> DDS, Researcher, Department of Health Information, Institute for Quality and Efficiency in Health Care, Cologne, Germany.</nlm:aff></affiliation></author><author><name sortKey="Fedorowicz, Zbys" sort="Fedorowicz, Zbys" uniqKey="Fedorowicz Z" first="Zbys" last="Fedorowicz">Zbys Fedorowicz</name><affiliation><nlm:aff id="aff04"> MSc DPH, BDS, LDS RCS (Eng), Director, The Bahrain Branch of the UK Cochrane Centre, The Cochrane Collaboration, Awali, Bahrain.</nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Applied Oral Science</title><idno type="ISSN">1678-7757</idno><idno type="eISSN">1678-7765</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Open access publishing is becoming increasingly popular within the biomedical
sciences. SciELO, the Scientific Electronic Library Online, is a digital library
covering a selected collection of Brazilian scientific journals many of which provide
open access to full-text articles. This library includes a number of dental journals
some of which may include reports of clinical trials in English, Portuguese and/or
Spanish. Thus, SciELO could play an important role as a source of evidence for dental
healthcare interventions especially if it yields a sizeable number of high quality
reports.</p><sec><title>Objective</title><p>The aim of this study was to identify reports of clinical trials by handsearching
of dental journals that are accessible through SciELO, and to assess the overall
quality of these reports.</p></sec><sec><title>Material and methods</title><p>Electronic versions of six Brazilian dental Journals indexed in SciELO were
handsearched at <ext-link ext-link-type="uri" xlink:href="www.scielo.br">www.scielo.br</ext-link> in September 2008. Reports of clinical trials were
identified and classified as controlled clinical trials (CCTs - prospective,
experimental studies comparing 2 or more healthcare interventions in human beings)
or randomized controlled trials (RCTs - a random allocation method is clearly
reported), according to Cochrane eligibility criteria. Criteria to assess
methodological quality included: method of randomization, concealment of treatment
allocation, blinded outcome assessment, handling of withdrawals and losses and
whether an intention-totreat analysis had been carried out.</p></sec><sec><title>Results</title><p>The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no
description of either the method of randomization (75.3%) or concealment of the
allocation sequence (84.2%). Participants and outcome assessors were reported as
blinded in only 31.2% of the reports. Withdrawals and losses were only clearly
described in 6.5% of the reports and none mentioned an intention-totreat analysis
or any similar procedure.</p></sec><sec><title>Conclusions</title><p>The results of this study indicate that a substantial number of reports of trials
and systematic reviews are available in the dental journals listed in SciELO, and
that these could provide valuable evidence for clinical decision making. However,
it is clear that the quality of a number of these reports is of some concern and
that improvement in the conduct and reporting of these trials could be achieved if
authors adhered to internationally accepted guidelines, e.g. the CONSORT
statement.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Almerie, Mq" uniqKey="Almerie M">MQ Almerie</name></author><author><name sortKey="Matar, He" uniqKey="Matar H">HE Matar</name></author><author><name sortKey="Jones, V" uniqKey="Jones V">V Jones</name></author><author><name sortKey="Kumar, A" uniqKey="Kumar A">A Kumar</name></author><author><name sortKey="Wright, J" uniqKey="Wright J">J Wright</name></author><author><name sortKey="Wlostowska, E" uniqKey="Wlostowska E">E Wlostowska</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bickley, Sr" uniqKey="Bickley S">SR Bickley</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Cipriani, A" uniqKey="Cipriani A">A Cipriani</name></author><author><name sortKey="Malvini, L" uniqKey="Malvini L">L Malvini</name></author><author><name sortKey="Furukawa, Ta" uniqKey="Furukawa T">TA Furukawa</name></author><author><name sortKey="Barbui, C" uniqKey="Barbui C">C Barbui</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Clancy, Mj" uniqKey="Clancy M">MJ Clancy</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Doyle, H" uniqKey="Doyle H">H Doyle</name></author><author><name sortKey="Gass, A" uniqKey="Gass A">A Gass</name></author><author><name sortKey="Kennison, R" uniqKey="Kennison R">R Kennison</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Egger, M" uniqKey="Egger M">M Egger</name></author><author><name sortKey="Juni, P" uniqKey="Juni P">P Jüni</name></author><author><name sortKey="Bartlett, C" uniqKey="Bartlett C">C Bartlett</name></author><author><name sortKey="Holenstein, F" uniqKey="Holenstein F">F Holenstein</name></author><author><name sortKey="Sterne, J" uniqKey="Sterne J">J Sterne</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Frank, M" uniqKey="Frank M">M Frank</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Giglia, E" uniqKey="Giglia E">E Giglia</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gravel, J" uniqKey="Gravel J">J Gravel</name></author><author><name sortKey="Opatrny, L" uniqKey="Opatrny L">L Opatrny</name></author><author><name sortKey="Shapiro, S" uniqKey="Shapiro S">S Shapiro</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Haahr, Mt" uniqKey="Haahr M">MT Haahr</name></author><author><name sortKey="Hr Bjartsson, A" uniqKey="Hr Bjartsson A">A Hróbjartsson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Higgins, Jpt" uniqKey="Higgins J">JPT Higgins</name></author><author><name sortKey="Green, S" uniqKey="Green S">S Green</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jadad, Ar" uniqKey="Jadad A">AR Jadad</name></author><author><name sortKey="Moore, Ra" uniqKey="Moore R">RA Moore</name></author><author><name sortKey="Carroll, D" uniqKey="Carroll D">D Carroll</name></author><author><name sortKey="Jenkinson, C" uniqKey="Jenkinson C">C Jenkinson</name></author><author><name sortKey="Reynolds, Dj" uniqKey="Reynolds D">DJ Reynolds</name></author><author><name sortKey="Gavaghan, Dj" uniqKey="Gavaghan D">DJ Gavaghan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Juni, P" uniqKey="Juni P">P Jüni</name></author><author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name></author><author><name sortKey="Egger, M" uniqKey="Egger M">M Egger</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Muller, K" uniqKey="Muller K">K Muller</name></author><author><name sortKey="Morais, J" uniqKey="Morais J">J Morais</name></author><author><name sortKey="Feine, J" uniqKey="Feine J">J Feine</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nasser, N" uniqKey="Nasser N">N Nasser</name></author><author><name sortKey="Al Hajeri, A" uniqKey="Al Hajeri A">A Al-Hajeri</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nasser, M" uniqKey="Nasser M">M Nasser</name></author><author><name sortKey="Eisinga, A" uniqKey="Eisinga A">A Eisinga</name></author><author><name sortKey="Al Hajeri, A" uniqKey="Al Hajeri A">A Al-Hajeri</name></author><author><name sortKey="Fedorowicz, Z" uniqKey="Fedorowicz Z">Z Fedorowicz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Turp, Jc" uniqKey="Turp J">JC Türp</name></author><author><name sortKey="Schulte, Jm" uniqKey="Schulte J">JM Schulte</name></author><author><name sortKey="Antes, G" uniqKey="Antes G">G Antes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Warlick, Se" uniqKey="Warlick S">SE Warlick</name></author><author><name sortKey="Vaughan, Kt" uniqKey="Vaughan K">KT Vaughan</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Appl Oral Sci</journal-id><journal-id journal-id-type="iso-abbrev">J Appl Oral Sci</journal-id><journal-title-group><journal-title>Journal of Applied Oral Science</journal-title></journal-title-group><issn pub-type="ppub">1678-7757</issn><issn pub-type="epub">1678-7765</issn><publisher><publisher-name>Faculdade de Odontologia de Bauru da Universidade de São
Paulo</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">20485919</article-id><article-id pub-id-type="pmc">5349744</article-id><article-id pub-id-type="doi">10.1590/S1678-77572010000200002</article-id><article-categories><subj-group subj-group-type="heading"><subject>Systematic Review</subject></subj-group></article-categories><title-group><article-title>A quantitative and qualitative evaluation of reports of clinical trials
published in six Brazilian dental journals indexed in the Scientific Electronic
Library Online (SciELO)</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>de SOUZA</surname><given-names>Raphael Freitas</given-names></name><xref ref-type="aff" rid="aff01">1</xref><xref ref-type="corresp" rid="c01"></xref></contrib><contrib contrib-type="author"><name><surname>CHAVES</surname><given-names>Carolina de Andrade Lima</given-names></name><xref ref-type="aff" rid="aff02">2</xref></contrib><contrib contrib-type="author"><name><surname>CHAVES</surname><given-names>Carolina de Andrade Lima</given-names></name><xref ref-type="aff" rid="aff02">2</xref></contrib><contrib contrib-type="author"><name><surname>CHAVES</surname><given-names>Carolina de Andrade Lima</given-names></name><xref ref-type="aff" rid="aff02">2</xref></contrib><contrib contrib-type="author"><name><surname>NASSER</surname><given-names>Mona</given-names></name><xref ref-type="aff" rid="aff03">3</xref></contrib><contrib contrib-type="author"><name><surname>FEDOROWICZ</surname><given-names>Zbys</given-names></name><xref ref-type="aff" rid="aff04">4</xref></contrib></contrib-group><aff id="aff01"><label>1</label> DDS, PhD, Professor, Department of Dental Materials and Prosthodontics, Ribeirão Preto Dental School, University of São Paulo, Ribeirão Preto, SP, Brazil, and Visiting Professor, Faculty of Dentistry, McGill University, Montréal, QC, Canada.</aff><aff id="aff02"><label>2</label> DDS, PhD student, Department of Dental Materials and Prosthodontics, Araraquara Dental School, São Paulo State University, Araraquara, SP, Brazil.</aff><aff id="aff03"><label>3</label> DDS, Researcher, Department of Health Information, Institute for Quality and Efficiency in Health Care, Cologne, Germany.</aff><aff id="aff04"><label>4</label> MSc DPH, BDS, LDS RCS (Eng), Director, The Bahrain Branch of the UK Cochrane Centre, The Cochrane Collaboration, Awali, Bahrain.</aff><author-notes><corresp id="c01"><bold>Corresponding address:</bold> Raphael Freitas de Souza -
Universidade de São Paulo, Faculdade de Odontologia de Ribeirão Preto -
Av. do Café, s/n 14 040-050, Ribeirão Preto, SP, Brazil - Phone:
55-14-3603-4006 - e-mail: <email>raphael@forp.usp.br</email></corresp></author-notes><pub-date pub-type="epub-ppub"><season>Mar-Apr</season><year>2010</year></pub-date><pmc-comment>Fake ppub date generated by PMC from publisher
pub-date/@pub-type='epub-ppub' </pmc-comment>
<pub-date pub-type="ppub"><season>Mar-Apr</season><year>2010</year></pub-date><volume>18</volume><issue>2</issue><fpage>104</fpage><lpage>109</lpage><history><date date-type="received"><day>22</day><month>12</month><year>2008</year></date><date date-type="accepted"><day>16</day><month>9</month><year>2009</year></date></history><permissions><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an Open Access article distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly
cited.</license-p></license></permissions><abstract><p>Open access publishing is becoming increasingly popular within the biomedical
sciences. SciELO, the Scientific Electronic Library Online, is a digital library
covering a selected collection of Brazilian scientific journals many of which provide
open access to full-text articles. This library includes a number of dental journals
some of which may include reports of clinical trials in English, Portuguese and/or
Spanish. Thus, SciELO could play an important role as a source of evidence for dental
healthcare interventions especially if it yields a sizeable number of high quality
reports.</p><sec><title>Objective</title><p>The aim of this study was to identify reports of clinical trials by handsearching
of dental journals that are accessible through SciELO, and to assess the overall
quality of these reports.</p></sec><sec><title>Material and methods</title><p>Electronic versions of six Brazilian dental Journals indexed in SciELO were
handsearched at <ext-link ext-link-type="uri" xlink:href="www.scielo.br">www.scielo.br</ext-link> in September 2008. Reports of clinical trials were
identified and classified as controlled clinical trials (CCTs - prospective,
experimental studies comparing 2 or more healthcare interventions in human beings)
or randomized controlled trials (RCTs - a random allocation method is clearly
reported), according to Cochrane eligibility criteria. Criteria to assess
methodological quality included: method of randomization, concealment of treatment
allocation, blinded outcome assessment, handling of withdrawals and losses and
whether an intention-totreat analysis had been carried out.</p></sec><sec><title>Results</title><p>The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no
description of either the method of randomization (75.3%) or concealment of the
allocation sequence (84.2%). Participants and outcome assessors were reported as
blinded in only 31.2% of the reports. Withdrawals and losses were only clearly
described in 6.5% of the reports and none mentioned an intention-totreat analysis
or any similar procedure.</p></sec><sec><title>Conclusions</title><p>The results of this study indicate that a substantial number of reports of trials
and systematic reviews are available in the dental journals listed in SciELO, and
that these could provide valuable evidence for clinical decision making. However,
it is clear that the quality of a number of these reports is of some concern and
that improvement in the conduct and reporting of these trials could be achieved if
authors adhered to internationally accepted guidelines, e.g. the CONSORT
statement.</p></sec></abstract><kwd-group><kwd>Clinical trials as topic</kwd><kwd>Randomized controlled trials as topic</kwd><kwd>Evidence-based medicine</kwd><kwd>Bias</kwd><kwd>Journalism, dental</kwd></kwd-group></article-meta></front><body><sec sec-type="intro"><title>INTRODUCTION</title><p>There has been an increased trend over the last decade towards open access publishing of
health science literature<sup><xref rid="r08" ref-type="bibr">8</xref></sup>, the main
goals of which are the improvement of scholarly interaction, the creation of options for
sharing knowledge without cost and with a perception that this will lead to a reduction
in the barriers to the growth of science. In practical terms, published articles should
be available on the internet and should permit users to read, print and distribute the
documents without cost<sup><xref rid="r09" ref-type="bibr">9</xref></sup>. Despite the
obvious advantages for consumers of healthcare science, the increasing popularity of
open access publishing has had an impact on healthcare researchers. A study of the
perceptions of American medical researchers to open access publishing found that the
concept of free access was a significant influence in decision making about where to
publish research. Free access was the main reason for considering open access journals,
in addition to a belief that it would increase the visibility of research
findings<sup><xref rid="r19" ref-type="bibr">19</xref></sup>.</p><p>The Scientific Electronic Library Online (SciELO) has previously been highlighted as a
successful example of open access publishing<sup><xref rid="r06" ref-type="bibr">6</xref></sup>. It houses a collection of dental journals, which receive
manuscripts in English, Portuguese and/or Spanish, many of which might include clinical
trials, systematic reviews which could be an important source of evidence for
effectiveness of interventions in dentistry. This perception is in keeping with similar
findings from other regions which showed that many healthcare journals are a rich
resource of high quality clinical trials, irrespective of their lack of indexing in the
larger international databases. A study in which ten German dental journals were
handsearched for randomized clinical trials (RCTs) retrieved more than 200 reports, out
of which 43.8% were not available in MEDLINE<sup><xref rid="r18" ref-type="bibr">18</xref></sup>. A number of Iranian medical journals have also been shown to
contain a considerable number of trials which are not available through MEDLINE or
EMBASE<sup><xref rid="r16" ref-type="bibr">16</xref>,<xref rid="r17" ref-type="bibr">17</xref></sup>. Similar results have been found with Polish journals
where 40% of the reports of RCTs were not retrievable by means of a search on
MEDLINE<sup><xref rid="r01" ref-type="bibr">1</xref></sup>.Thus it is conceivable
that SciELO dental journals contain a substantial number of reports of clinical trials
which are not widely accessible but which could be an important source of both evidence
for effectiveness of healthcare interventions and a potential source of eligible studies
for systematic reviews.</p><p>Regardless of the number of reports of trials in SciELO it is essential that they are
robust in methodological quality and that reasonable attempts have been made by
investigators to minimize the risk of systematic bias. Control of bias in clinical
trials is directly related to several important procedural aspects of trial conduction,
i.e. random and concealed allocation to intervention and control and the effective
blinding of participants, investigators and outcomes assessors<sup><xref rid="r14" ref-type="bibr">14</xref></sup>. A comprehensive accounting for losses or withdrawals is
a prerequisite in the control of bias and any losses to follow up or withdrawals should
be adequately described in the reports<sup><xref rid="r13" ref-type="bibr">13</xref></sup>.</p><p>The role of SciELO as a source of high-level evidence for the effectiveness of oral
healthcare interventions can best be illustrated through a comprehensive examination of
the quality of reports of clinical trials published in journals accessible through this
database. This study sought to identify and assess the risk of bias in reports of
clinical trials published in Brazilian dental journals that are accessible through
SciELO.</p></sec><sec sec-type="materials|methods"><title>MATERIALS AND METHODS</title><p>A pilot search of the SciELO database, via <ext-link ext-link-type="uri" xlink:href="www.scielo.br">www.scielo.br</ext-link>, was conducted in February and
subsequently updated in September of 2008. Journals listed under the heading “health
sciences” were assessed for eligibility based on two principal criteria; the selected
journal focused on general dentistry or a dental specialty or on related topics, and was
a Brazilian journal indexed in the Brazilian section of SciELO. There were no language
restrictions and both active and inactive titles were eligible for inclusion.</p><p>Each issue of the included journal was handsearched via the SciELO home page, and
although the handsearching was conducted on electronic copies rather than print issues
the methods used were as described in the Cochrane Oral Health Review Group Journal
studies were considered eligible based on four criteria: (I) healthcare treatment or
interventions were compared, in human beings; (II) prospective and experimental study;
(III) two or more treatments or interventions were compared to one another or to a
control (inactive) group; (IV) assignment of participants, parts of the body or clusters
to treatments or interventions was intended to be random. In other words, a report was
not eligible for inclusion if participants were explicitly assigned to interventions
using some method other than randomization or quasi-randomization. If eligible, these
reports were further classified according to the method used for random assignment,
according to two categories:</p><p>1. RCT: the report clearly stated that random allocation was used, or described a
procedure such as the use of computer-generated codes or random number tables for
defining assignment;</p><p>2. Controlled clinical trial (CCT): the report did not cite the use of random allocation
or true random methods. This classification was also employed for articles which cited
the use of quasirandom methods, such as alternate allocation or use of social security
numbers.</p><p>The methodological quality of the trial reports was assessed based on the criterion
grading system described in the Cochrane Handbook for Systematic Reviews of
Interventions 5.0.0<sup><xref rid="r12" ref-type="bibr">12</xref></sup> (<xref ref-type="table" rid="t01">Figure 1</xref>). All search and quality assessment
procedures were carried out independently by two researchers (CALC and RFS).
Disagreements in assessment were discussed and resolved through consensus and if
necessary through consultation with a third party, which was either (MN or ZF).</p><table-wrap id="t01" orientation="portrait" position="float"><label>Figure 1</label><caption><title>Criteria for quality assessment</title></caption><table frame="box" rules="cols"><thead><tr style="border-bottom-style:solid; border-bottom-width:thin"><th align="left" rowspan="1" colspan="1"><bold>Criterion</bold></th><th align="left" rowspan="1" colspan="1"><bold>Classification</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">Randomization</td><td align="left" rowspan="1" colspan="1">(A) adequate - include any one of the following methods of
sequence generation: computer generated or table of random numbers, drawing
of lots, coin-toss, shuffling cards or throw of a dice; <break></break> (B)
unclear; <break></break> (C) inadequate - sequence generation using any of the
following: case record number, date of birth or alternate numbers.</td></tr><tr><td align="left" rowspan="1" colspan="1">Concealment of allocation</td><td align="left" rowspan="1" colspan="1">(A) adequate - either central sequence generation or
sequentially numbered sealed opaque envelopes; <break></break> (B) unclear;
<break></break> (C) inadequate - open allocation sequence and the participants and
trialists could foresee the upcoming assignment.</td></tr><tr><td align="left" rowspan="1" colspan="1">Blinding</td><td align="left" rowspan="1" colspan="1">(a) blinding of participants (yes/no/unclear/not applicable);
<break></break> (b) blinding of caregiver (yes/no/unclear/not applicable);<break></break>(c) blinding of outcome assessor (yes/no/unclear/not applicable); <break></break>(d) blinding of data analyst (yes/no/unclear/not applicable).</td></tr><tr><td align="left" rowspan="1" colspan="1">Handling of withdrawals and losses</td><td align="left" rowspan="1" colspan="1">(A) yes (there was a clear description given of the difference
between the two groups of losses to follow up);<break></break> (B) unclear;
<break></break> (C) no.</td></tr><tr><td align="left" rowspan="1" colspan="1">Intention-to-treat(ITT) analysis</td><td align="left" rowspan="1" colspan="1">(A) yes (ITT was mentioned among the analyses); <break></break> (B)
unclear;<break></break> (C) No (per-protocol analysis); <break></break> (D) Not applicable
(there was no withdrawal or loss at follow-up).</td></tr></tbody></table></table-wrap><p>As this was a descriptive study, data for quality assessment was presented only as
frequency counts.</p></sec><sec sec-type="results"><title>RESULTS</title><p>The initial search retrieved six titles for eligible journals (<xref ref-type="table" rid="t02">Figure 2</xref>). The titles A, B and C were for three independent
journals, whereas the titles D and E were not being published anymore. Both were
continued by the title F. A considerable number of reports of clinical trials and a few
systematic reviews were identified in the journals which were searched.</p><table-wrap id="t02" orientation="portrait" position="float"><label>Figure 2</label><caption><title>Characteristics of the Brazilian Oral Health journals in SciELO and
classification of reports</title></caption><table frame="box" rules="cols"><thead><tr><th rowspan="2" colspan="1"><bold>Journals</bold></th><th colspan="3" align="center" rowspan="1"><bold>Characteristics</bold></th><th colspan="3" align="center" rowspan="1"><bold>Classification</bold></th></tr><tr style="border-bottom-style:solid; border-bottom-width:thin"><th align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold>Frequency</bold></th><th align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold> Issues</bold></th><th align="center" rowspan="1" colspan="1"><bold>Subject</bold></th><th align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold>CCT</bold></th><th align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold>RCT</bold></th><th align="center" rowspan="1" colspan="1"><bold> Total</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">(A) Revista Dental Press de Ortodontia e Ortopedia Facial
<italic> (Dental Press</italic><italic> Journal of Orthodontics and Facial</italic><italic> Orthopedics)</italic></td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Bimonthly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">20</td><td align="center" rowspan="1" colspan="1">Orthodontics</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">2</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">2</td><td align="center" rowspan="1" colspan="1"> 4</td></tr><tr><td align="left" rowspan="1" colspan="1">(B) Brazilian Dental Journal</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Quarterly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">21</td><td align="center" rowspan="1" colspan="1">General</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">8</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">8 </td><td align="center" rowspan="1" colspan="1">16</td></tr><tr><td align="left" rowspan="1" colspan="1">(C) Journal of Applied Oral Science</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Bimonthly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">27</td><td align="center" rowspan="1" colspan="1">General</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">9</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">15</td><td align="center" rowspan="1" colspan="1"> 24</td></tr><tr><td align="left" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">+ 2 Special Issues</td><td align="center" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" rowspan="1" colspan="1"> </td></tr><tr><td align="left" rowspan="1" colspan="1">(D) Revista de Odontologia da Universidade de São Paulo
<italic>(University </italic><italic>of São Paulo Dental Journal)</italic></td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Quarterly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">11</td><td align="center" rowspan="1" colspan="1">General</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">4</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">0 </td><td align="center" rowspan="1" colspan="1">4</td></tr><tr><td align="left" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">+ 1 Supplement</td><td align="center" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" rowspan="1" colspan="1"> </td></tr><tr><td rowspan="2" align="left" colspan="1">(E) Pesquisa Odontológica Brasileira
<italic>(Brazilian Oral Research)</italic></td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Quarterly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">16</td><td align="center" rowspan="1" colspan="1">General</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">7</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">6</td><td align="center" rowspan="1" colspan="1"> 13</td></tr><tr><td style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">+ 1 Supplement</td><td rowspan="1" colspan="1"> </td><td style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td rowspan="1" colspan="1"> </td></tr><tr><td align="left" rowspan="1" colspan="1">(F) Brazilian Oral Research</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">Quarterly</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">18</td><td align="center" rowspan="1" colspan="1">General</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">3</td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1">12</td><td align="center" rowspan="1" colspan="1"> 15</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Total</bold></td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"> </td><td align="center" rowspan="1" colspan="1"> </td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold>33</bold></td><td align="center" style="border-right-style:hidden" rowspan="1" colspan="1"><bold>43</bold></td><td align="center" rowspan="1" colspan="1"><bold> 76</bold></td></tr></tbody></table></table-wrap><p>Quality assessment of the reports illustrated that 75.3% of the reports did not explain
how participants were randomized, and 84.2% did not indicate the methods used to conceal
the allocation sequence (<xref ref-type="fig" rid="f01">Figure 3A</xref>). Of the
included reports, 13.2% and 5.3% respectively, confirmed inadequate methods for the
randomization and concealment of allocation criteria.</p><fig id="f01" orientation="portrait" position="float"><label>Figure 3</label><caption><p>Results for methodological quality assessment. (A) Randomization and concealment
of allocation, (B) Blinding, and (C) Handling of withdrawals and losses and
intention-to-treat analysis. N/A: not applicable</p></caption><graphic xlink:href="jaos-18-02-0104-g01"></graphic></fig><p>The most frequently used method for control of bias was blinding of participants or
assessment of outcomes, which were both described in 31.6% of the reports. Blinding of
caregivers was much less frequent (9.2%); whereas data analysts were seldom described as
blinded (unclear for 97.4%) (<xref ref-type="fig" rid="f01">Figure 3B</xref>). Despite
this higher frequency of reports with adequate blinding, most of the studies were either
underreported or appeared to be of low methodological quality.</p><p>Handling of withdrawals and losses was unclear for a large proportion of the reports
(75.0%), and 18.4% of the reports provided inadequate descriptions (<xref ref-type="fig" rid="f01">Figure. 3C</xref>). None of the reports of trials made any mention of an
intention-to-treat analysis, although it was clearly necessary in more than 15% of
them.</p></sec><sec sec-type="discussion"><title>DISCUSSION</title><p>This study confirmed the availability of a substantial number of reports of clinical
trials and systematic reviews in Brazilian dental journals listed in the SciELO
database. However, although the findings reinforce the relevance of those journals as a
source of evidence for the effectiveness of oral healthcare interventions there are
several important implications to this current study.</p><p>Firstly, SciELO should be considered a useful resource for clinical decision making in
dentistry in much the same way as a number of other regional databases, in both
medicine<sup><xref rid="r01" ref-type="bibr">1</xref>,<xref rid="r16" ref-type="bibr">16</xref></sup> and oral health<sup><xref rid="r18" ref-type="bibr">18</xref></sup>. Those databases, as with SciELO, contain a considerable number
of reports which are not currently indexed in MEDLINE or EMBASE, and their relevance for
regional settings would justify their use. Secondly, additional benefits in
strengthening the evidence base for effectiveness of oral healthcare interventions would
be accrued through their inclusion in search strategies for systematic reviews. It is
recognised that searches which are restricted to international databases such as MEDLINE
may result in a higher risk of bias than more comprehensive approaches, depending on the
nature and direction of the results<sup><xref rid="r07" ref-type="bibr">7</xref></sup>.
Future studies might attempt to develop and test search filters for SciELO, which could
assist in extracting previously inaccessible reports of trials.</p><p>Quality assessment of the trials identified for evaluation revealed a huge proportion of
reports with methodological deficiencies. Procedures critical for the control of
selection bias<sup><xref rid="r14" ref-type="bibr">14</xref></sup>, such as those
associated with randomization and allocation concealment were infrequently described in
the reports and which in some instances highlighted the use of an inadequate procedure.
Inadequate randomization can result in differences among groups at baseline and thus
differences in outcomes may be incorrectly attributed to confounding variables instead
of the tested interventions<sup><xref rid="r05" ref-type="bibr">5</xref></sup>. Open
allocation can lead to bias by providing conditions for excluding certain participants
from one intervention group or the other<sup><xref rid="r14" ref-type="bibr">14</xref></sup>. Open allocation may facilitate the allocation of a more complex
case to the placebo rather than the active intervention arm of a trial.</p><p>Somewhat surprisingly, blinding was more frequently employed, although most reports were
unclear about who was blinded and precisely how and when this was achieved. Several
studies had one or more interventions or situations where blinding would not be
applicable or feasible, i.e. it would not be possible to blind participants to
conventional complete dentures or implantretained overdentures in a trial which included
edentulous patients<sup><xref rid="r15" ref-type="bibr">15</xref></sup>. Not one single
study reported blinding of data analysts and seldom were caregivers reported as blinded.
Several reports cited the use of double-blinding, but did not indicate who was blinded
and at which stage of the study. Blinding is essential for the control of performance
and detection bias and should be viewed as being quite distinct from allocation
concealment, and even though both aim to control bias they are employed at different
stages of a trial. Performance bias is minimized by adequate blinding and refers to
possible systematic differences in the care provided for participants of each group,
other than those planned a priori. The blinding of outcome assessors, if feasible, can
also reduce detection bias, attributed to systematic differences between groups during
outcome assessment<sup><xref rid="r12" ref-type="bibr">12</xref></sup>.</p><p>Attrition bias which was a further concern in our findings refers to systematic
differences between groups due to the loss of participants during a study<sup><xref rid="r14" ref-type="bibr">14</xref></sup>. Despite its relevance, only 5 reports
adequately cited how many enrolled participants completed the studies. Not a single
study cited the use of intention-to-treat analysis, which was quite surprising in view
of the generally inadequate description of withdrawals and losses. Missing data is a
common theme even in studies published in leading medical journals<sup><xref rid="r10" ref-type="bibr">10</xref></sup>, it is tempting therefore to assume that
several of the reports assessed in this study did not conduct an intention
to-treat-analysis if appropriate, more especially as in many instances any reference to
withdrawals and losses was omitted.</p><p>An important consideration of this study is that a distinction should be made between
the quality of reporting and the methodological quality of the trials and the only way
to disentangle these would be through direct contact with the investigators in the
trials. However, excessively positive responses can be expected when authors are asked
about control of bias and this is not infrequently accompanied by over
optimism<sup><xref rid="r11" ref-type="bibr">11</xref></sup>.</p><p>An earlier study evaluating the quality of clinical trials conducted in juvenile
idiopathic arthritis noted that there was a significant improvement in the quality of
reports after 1996<sup><xref rid="r04" ref-type="bibr">4</xref></sup>. According to the
authors, this improvement was most probably due to the publication of the CONSORT
statement and to the establishment of international networks for the conduct of
high-quality trials in children with rheumatic diseases<sup><xref rid="r02" ref-type="bibr">2</xref></sup>. Thus, one might expect significant improvements in trial
quality if both authors and editors of Brazilian dental journals adhered to the
guidelines, such as those expressed by the Cochrane Collaboration or the CONSORT
statement. In addition it would be helpful if, authors of trial protocols consider the
possibilities of working in groups which include at least one methodologist. A more
ambitious approach for the improvement of trial quality would be the establishment of
networks for discussing and planning clinical experimental studies in dentistry.</p></sec><sec sec-type="conclusions"><title>CONCLUSIONS</title><p>A substantial number of reports of clinical trials are available in dental journals
accessible through the SciELO database. Although these trials can provide valuable
evidence for clinical decision making, the present assessment showed that the quality of
many of these reports is a concern, and that future improvements in trial conduction are
likely to be driven by authors adhering more closely to internationally accepted
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