Publications committee of a multicenter study and computerized support system publielsa

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1 Rev Saúde Pública 2013;47(Supl 2) Articles DOI: /S Marilia Sá Carvalho I Maurício Lima Barreto II Cláudia Media Coeli III Rafael Moteiro Raposo III Eduardo Luiz Adrade Mota II Bruce Bartholow Duca IV Publicatios committee of a multiceter study ad computerized support system publielsa ABSTRACT The publicatios committee of a multiceter study has the aim of orgaizig the proposals for articles, so as to esure wide-ragig access to the data, quality ad precedece. A olie iformatio ad maagemet system for study proposals (publielsa) was developed, composed of three modules: (i) submissio ad approval of proposals; (ii) follow-up of approved proposals; ad (iii) cosolidated reports. The first module allows ay iterested party to search for ad become acquaited with articles that have already bee published or are i progress ad submit ew proposals. The approval process ad data trasfer to the researcher resposible is orgaized at this stage. I the secod module, the aim is to moitor proposals approved util they are fially published. The third module eables searchig for ad viewig proposals ad articles. The system has iovative characteristics, especially with regard to ecouragig cooperatio betwee differet researchers, through circulatio of iformatio o each proposal submitted. I this maer, iteractio betwee differet viewpoits ad experieces ivolved i the research is stimulated. DESCRIPTORS: Publicatios, ethics. Scietific ad Techical Publicatios. Authorship ad Co-Authorship i Scietific Publicatios. Iformatio Systems, orgaizatio & admiistratio. Scietific Publicatio Ethics. Multiceter Studies as Topic. Cohort Studies. I Fudação Oswaldo Cruz. Rio de Jaeiro, RJ, Brasil II Uiversidade Federal da Bahia. Salvador, BA, Brasil III Uiversidade Federal do Rio de Jaeiro. Rio de Jaeiro, RJ, Brasil IV Uiversidade Federal do Rio Grade do Sul. Porto Alegre, RS, Brasil Correspodece: Marilia Sá Carvalho Fudação Oswaldo Cruz Atiga Residêcia Oficial Av. Brasil, 4365 Maguihos Rio de Jaeiro, RJ, Brasil carvalho@fiocruz.br Received: 6/10/2011 Approved: 7/2/2012 Article available from:

2 2 Publicatios committee ad publielsa Carvalho MS et al INTRODUCTION Ay large-scale multiceter study with a perspective of log-term data-gatherig i successive waves ecessarily has to develop a mechaism that makes it possible to orgaize the proposals for articles. This mechaism must esure that: the data ad biological material of the participats are used exactly as foresee i the free ad iformed coset statemet; 2 the data access is sufficietly wide for the scietific commuity to beefit from it; 1 the same issue is ot ivestigated by two groups of researchers idepedetly ad at the same time; a proposal ot accomplished over a reasoable time frame does ot prevet other researchers from ivestigatig the same issue; ad the studies published have a high academic stadard. 4 Based o the experiece accumulated i several large cohort studies, a a Publicatio Committee was created i the Brazilia Logitudial Study for Adult Health (Estudo Logitudial de Saúde do Adulto, ELSA- Brasil). A member of each Ivestigatio Ceter participates i the Committee, which is coordiated by a seior researcher with great experiece i similar sized projects. Developmet of a olie iformatio ad maagemet system to register ad make it possible to follow up proposals for studies ad publicatios was cosidered essetial for the committee s tasks. This article presets the system called publielsa, with emphasis o the characteristics of ELSA-Brasil that distiguish it, especially its setup as a cosortium of six research ceters. DESCRIPTION OF THE SYSTEM: PUBLIELSA The creatio of publielsa followed the modelig priciples of the stages of the editorial process, with a stadardized set of aalysis tasks o proposals for publicatio, o commuicatio betwee the committee ad the researchers makig the proposals ad o deadlies ad demads, thereby establishig specific routies ad modes of validatio that would be appropriate for the purposes of ELSA-Brasil. A collaborative ad dyamic eviromet was created, with a computerized iterface that made it easy to orgaize, publish ad retrieve research papers, eve by idividuals who are ufamiliar with applicatios used for these purposes. The system is composed by three modules: (i) submissio ad approval of the proposal; (ii) follow-up of the approved proposal; ad (iii) reports. The guidace maual for usig the system is available o the Iteret b ad ca be accessed directly through this address, or from the ELSA platform c i the area devoted to researchers. The first module has the objective of allowig ay researcher iterested i aalyzig the data of the study to submit a proposal i a structured maer, with sufficiet iformatio to avoid overlappig with ogoig studies. I this module, researchers are registered, have access to a system for searchig for ogoig proposals ad ca submit their ow proposals. I this regard, some iovative aspects of this istrumet were implemeted for the publicatio committee to fuctio. The abstract of the proposed study with the respective list of authors is forwarded to all the members of the committee ad to the etire research steerig committee (CDir) through electroic mail. For 15 days, the study awaits evaluatio ad, durig this period, other authors ca be added to the proposal. This deadlie has the objective of stimulatig joit aalyses ad publicatios amog ivestigators at the differet study ceters. The fial decisio o co-authorship is uder the resposibility of the researcher who submitted the proposal. Followig this, the proposal is evaluated by the coordiator of the committee, who ca request the opiio of ad-hoc cosultats. The fial decisio is up to the members of the publicatio committee, who issue a coclusive opiio, cosistig of defiitive approval, rejectio or recommedatios for alteratios (Figure). After the proposal has bee approved, the researcher resposible for the proposal is authorized to request the database cotaiig the variables eeded for the study, from the Data Ceter. PubliELSA allows researchers, icludig those who are ot registered i the system, to cosult the approved proposals without restrictio, with the aim of promotig wide dissemiatio of iformatio o the study proposals that are uder developmet withi ELSA-Brasil. The aim i the secod module is to moitor the approved proposals. The researchers resposible for a approved proposal have a deadlie of oe year to coduct the study ad fialize the proposed mauscript. Prorogatios ca be obtaied o request, but if the researchers resposible for the origial proposal are uable to implemet it withi the deadlie offered, the publicatio committee will be prepared to cosider similar proposals submitted by other groups of researchers. The quality of the fial mauscript is evaluated by the committee, which idicates a mai reporter from amog its members ad, whe ecessary, requests the opiio of a specialist. The system provides differetiated treatmet (fast-trackig) for cogress abstracts or for a Atherosclerosis Risk I Commuities. Procedure for submittig a mauscript proposal: updated 30 March, [cited 2011, Oct 1]. Available from: b PubliELSA. [cited 2013, Feb 27]. Available at: c ELSA Brasil. [cited 2013, Feb 27]. Available at:

3 Rev Saúde Pública 2013;47(Supl 2) 3 Basic flow of the ELSA system Module I CDir Author Submits proposal 15 days for fial submissio ELSA researchers Seds respose: - approved - alteratios required - rejected Secretary OK y Requests correctios Coordiator Seds rejectio Accepts y Verifies type of y Abstract? proposal Everyoe i the Committee evaluates Idicatio of the Coordiator Cosultat Coordiator receives opiios Two members of the Committee make evaluatios Opiios Has the 15-day deadlie expired? y Warig by Figure. Flow chart for publielsa.

4 4 Publicatios committee ad publielsa Carvalho MS et al fidigs that have cliical or epidemiological implicatios that demad rapid publicatio. The evaluatio of the geeral quality of the product icludes the matchig betwee the proposed questio ad the aalysis used, the writig ad the laguage proposed for the paper. The mauscript ca the receive the fial decisio from the committee i oe of the followig categories: approved, approved with commets (a situatio i which the author is ot obliged to accept the commets), approved coditioally or rejected. Oce approved, the authors are authorized to submit the study to ay scietific joural that they choose. Every six moths, publielsa will demad iformatio o the situatio of the mauscript, ad this requiremet will oly ed whe the mauscript has bee accepted by a joural. The authors should iform the defiitive ad complete referece wheever there is oe, as well as the Digital Object Idetifier. 3 Master s, doctoral or postdoctoral projects are treated i a differetiated maer. This is firstly because of the time eeded to coclude the studies, which is a period durig which the topic is reserved for the studet. I this case, a balace is sought betwee the time that the studet eeds ad the blockig of a topic that may be of iterest to other researchers. Oce the project has bee submitted, CDir receives the abstract ad has oe moth to evaluate the proposal. If the topic is of specific iterest to researchers of the cetral ucleus of the project, this time is sufficiet to resolve the issue betwee the iterested parties. Fially, the report module cosists of search routies for proposals ad published articles, with access to differetiated iformatio accordig to the type of users (members of the publicatio committee/secretary ad authors). The outputs available iclude: viewig of all the proposals submitted with iformatio o deadlies, titles ad types of study; viewig of proposals that are late ad/or for which extesios of the deadlie have bee requested; viewig of the ad hoc cosultats who have ot respoded to the requests; fial opiios o the study; list of the articles submitted for publicatio, with the joural, title, author, abstract ad deadlie; list of the proposals approved; list of the fialized articles ad the published articles, with the bibliographic details. The system was developed usig free laguages ad code programs. The laguage used was PHP with the MySQL database maagemet system, hosted o a server usig the GNU/Liux operatig system. POINTS FOR DEBATE Some iovatios i the processes of evaluatio ad maagemet of proposals for studies ad publicatios have clearly bee itroduced through publielsa. However, some issues form reovated challeges for the model adopted. For example, with regard to proposals for doctoral theses, because of their authorship ature, the exact form i which other researchers will be icluded still awaits defiitios, also takig ito cosideratio the differet practices ad regulatios i differet postgraduate courses. The priority is to ecourage cooperatio, but i some specific situatios it may be ecessary to seek alterative solutios for implemetig this. These issues also iclude the mechaisms ad documetatio eeded for accessig the data, such as the commitmet statemet that is to be siged by the proposig researcher, which has to be coheret with the ethical requiremets of ELSA-Brasil. The system site, liks, viewig space for variables, published papers ad mauals, amog other issues, are curretly uder developmet. The relatioship betwee the publicatio committee ad the approval of supplemetary studies is particularly relevat i this debate. These studies eed to be approved by CDir, especially whe they ivolve ew sampligs ad examiatios o participats. However, some studies mix data from differet sources, partly from ELSA-Brasil ad partly from cotextual variables, such as those relatig to the home or work eviromet, without ew sampligs. I these cases, the publicatios committee itself decides how to forward each proposal, requestig attetio from CDir whe ecessary. Oe importat issue, commo to all large multiceter studies like ELSA-Brasil, is the chage i culture demaded by this evaluatio model. The opportuity to take part i a study of this size, with the quality of the geerated data, presets to researchers fulfillmet of two additioal stages i proposig a research project ad preparig a article: evaluatio of the proposal ad evaluatio of the fialized mauscript. O the oe had, this represets a potetial problem whe it icreases the legth of time betwee the idea ad formulatio of the problem by the researcher ad the submissio of the mauscript to a scietific joural. O the other had, this process esures quality of scietific productio for ELSA-Brasil ad adds value to the article through revisios prior to the formal submissio to a scietific joural. This may reduce the evaluatio time by the joural ad may eve icrease the chace of acceptace. There is also the risk that the procedures of publielsa represet bureaucratizatio of the evaluatio process of scietific productio i this cotext, especially because the quality cotrol ad verificatio of the proposal s primacy i relatio to the objectives of ELSA-Brasil falls uder the resposibility of the publicatio committee. However, the cultural chages caused by these matters are directed towards the quality of the products ad, thus, their scietific impact. Every effort towards simplifyig the admiistrative stages is made,

5 Rev Saúde Pública 2013;47(Supl 2) 5 so that the committee ca always cocetrate o issues of merit ad ethics i evaluatig ay proposal or article. The most iovative aspect of the system is the stimulus towards wider cooperatio amog ELSA-Brasil researchers. This is coheret with the decetralized ad cooperative ature of this study i which there is o pricipal ivestigator, but a etwork structure that has bee cotiually improved throughout the developmet phases of the project. Eve cosiderig that the resposibility regardig co-authorship formally lies with the perso who submitted the proposal, circulatio of iformatio amog the idividuals resposible for the study will cotribute towards clear demarcatio of the real co-authorship, i lie with the recommedatios of the Iteratioal Committee of Medical Joural Editors. d Moreover, formulatio ad applicatio of ew iformatio techology to the maagemet of scietific kowledge productio, which characterizes publielsa, costitutes a legacy for istitutios, other research projects ad researcher commuities, who have at their disposal a auxiliary istrumet for evaluatig ad followig up studies ad publicatios. Two other Brazilia multiceter projects have recetly asked to use the system. e Lastly, ELSA-Brasil is committed f to stimulatig parterships ot oly amog its researchers, but also with the atioal ad iteratioal scietific commuity, ad to supportig researcher traiig, especially i the eediest regios. Overall, the ELSA-Brasil etwork aims to esure fulfillmet of these objectives; the publicatio committee aims to make them easier to accomplish, ad publielsa is its mai istrumet. We ivite iterested researchers to visit the webpage or to cotact publielsa. The source code of the software is available o request. d Iteratioal Committee of Medical Jourals Editors. Uiform requiremets for mauscripts submitted to biomedical jourals: ethical cosideratios i the coduct ad reportig of research: authorship ad cotributorship. [cited 2012, Ju 1]. Available from: icmje.org/ethical_1author.html e Nascer o Brasil: iquérito acioal sobre parto e ascimeto. Rio de Jaeiro; ENSP/Fiocruz; 2012 [cited 2012, Ju 1]. Available from: f Projeto EPIGEN-Brasil: epidemiologia geômica de doeças complexas em coortes brasileiras de base populacioal. Salvador; Istituto de Saúde Coletiva/UFBA; 2013 [cited 2013, Mar 5]. Available from: php?cod=33&page=2&active=2

6 6 Publicatios committee ad publielsa Carvalho MS et al REFERENCES 1. Carvalho ECA, Batilaa AP, Simkis J, Martis H, Shah J, Rajgor D, et al. Applicatio descriptio ad policy model i collaborative eviromet for sharig of iformatio o epidemiological ad cliical research data sets. PLoS ONE. 2010;5(2):e9314. DOI: /joural.poe Coucil for Iteratioal Orgaizatios of Medical Scieces - CIOMS. Iteratioal ethical guidelies o epidemiological studies. Geeva: World Health Orgaizatio; Paski N. The DOI hadbook. ed Oxford: Iteratioal DOI Foudatio; 2006 [citado 2011 out 1]. Dispoível em: hadbook_2000/doihadbook-v4-4.pdf 4. Szklo M. Quality of scietific articles. Rev Saude Publica. 2006;40(N. Espec):30-5. DOI: /S The system was fiaced by the Research Support Foudatio of the State of Rio de Jaeiro (Fudação de Amparo à Pesquisa do Estado do Rio de Jaeiro, FAPERJ; procedural umber E-26/ /2008). The Brazilia Logitudial Study for Adult Health (ELSA-Brasil) was fuded by the Brazilia Miistry of Health (Divisio of Sciece ad Techology [DECIT] of the Departmet of Sciece ad Techology) ad the Brazilia Miistry of Sciece ad Techology (FINEP Studies ad Projects Fiace Orgaizatio ad CNPq Natioal Coucil for Scietific ad Techology Developmet, protocol umbers RS, BA, ES, MG, SP, RJ). The authors declare that there are o coflicts of iterest. This mauscript was submitted for publicatio ad uderwet a peer review process as ay other mauscripts submitted to this publicatio, ad aoymity was guarateed for authors ad reviewers. Editors ad reviewers declare o coflicts of iterest that may affect the peer-review process.

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