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ABSTRACT The SPIRIT 2013 statement aims to improve the completeness of clinical trial protocol reporting by providing evidence-based recommendations for the minimum set of items to be addressed. This guidance has been instrumental in promoting transparent evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate their impact on health outcomes. The SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trial protocols evaluating interventions with an AI component. It was developed in parallel with its companion statement for trial reports: CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 26 candidate items, which were consulted upon by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The SPIRIT-AI extension includes 15 new items that were considered sufficiently important for clinical trial protocols of AI interventions. These new items should be routinely reported in addition to the core SPIRIT 2013 items. SPIRIT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention will be integrated, considerations for the handling of input and output data, the human–AI interaction and analysis of error cases. SPIRIT-AI will help promote transparency and completeness for clinical trial protocols for AI interventions. Its use will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the design and risk of bias for a planned clinical trial.

RESUMO A declaração SPIRIT 2013 tem como objetivo melhorar a integralidade dos relatórios dos protocolos de ensaios clínicos, fornecendo recomendações baseadas em evidências para o conjunto mínimo de itens que devem ser abordados. Essas orientações têm sido fundamentais para promover uma avaliação transparente de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials - Artificial Intelligence) é uma nova diretriz de relatório para protocolos de ensaios clínicos que avaliam intervenções com um componente de IA. Essa diretriz foi desenvolvida em paralelo à sua declaração complementar para relatórios de ensaios clínicos, CONSORT-AI (Consolidated Standards of Reporting Trials - Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 26 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão SPIRIT-AI inclui 15 itens novos que foram considerados suficientemente importantes para os protocolos de ensaios clínicos com intervenções que utilizam IA. Esses itens novos devem constar dos relatórios de rotina, juntamente com os itens básicos da SPIRIT 2013. A SPIRIT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA será integrada, considerações sobre o manuseio dos dados de entrada e saída, a interação humano-IA e a análise de casos de erro. A SPIRIT-AI ajudará a promover a transparência e a integralidade nos protocolos de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente o delineamento e o risco de viés de um futuro estudo clínico.

https://doi.org/10.26633/rpsp.2024.12

Directrices para presentación de informes de ensayos clínicos sobre intervenciones con inteligencia artificial: extensión CONSORT-AI
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Liu, Xiaoxuan

; Cruz Rivera, Samantha

; Moher, David

; Calvert, Melanie J.

; Denniston, Alastair K.

; Chan, An-Wen

; Darzi, Ara

; Holmes, Christopher

; Yau, Christopher

; Moher, David

; Ashrafian, Hutan

; Deeks, Jonathan J.

; Ferrante di Ruffano, Lavinia

; Faes, Livia

; Calvert, Melanie J.

; Keane, Pearse A.

; Cruz Rivera, Samantha

; Vollmer, Sebastian J.

; Liu, Xiaoxuan

; Lee, Aaron Y.

; Jonas, Adrian

; Esteva, Andre

; Beam, Andrew L.

; Chan, An-Wen

; Panico, Maria Beatrice

; Lee, Cecilia S.

; Haug, Charlotte

; Kelly, Christophe J.

; Yau, Christopher

; Mulrow, Cynthia

; Espinoza, Cyrus

; Fletcher, John

; Moher, David

; Paltoo, Dina

; Manna, Elaine

; Price, Gary

; Collins, Gary S.

; Harvey, Hugh

; Matcham, James

; Monteiro, Joao

; Khair ElZarrad, M.

; Ferrante di Ruffano, Lavinia

; Oakden-Rayner, Luke

; Calvert, Melanie J.

; McCradden, Melissa

; Keane, Pearse A.

; Savage, Richard

; Golub, Robert

; Sarkar, Rupa

; Rowley, Samuel

Revista Panamericana de Salud Pública

Journal Metrics
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2024, Volume 48 elocation e13

Abstract: Es En Pt | Text: Es En Pt | PDF: Es | PDF: En | PDF: Pt

resumen está disponible en el texto completo

ABSTRACT The CONSORT 2010 statement provides minimum guidelines for reporting randomized trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders) and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.

RESUMO A declaração CONSORT 2010 apresenta diretrizes mínimas para relatórios de ensaios clínicos randomizados. Seu uso generalizado tem sido fundamental para garantir a transparência na avaliação de novas intervenções. Recentemente, tem-se reconhecido cada vez mais que intervenções que incluem inteligência artificial (IA) precisam ser submetidas a uma avaliação rigorosa e prospectiva para demonstrar seus impactos sobre os resultados de saúde. A extensão CONSORT-AI (Consolidated Standards of Reporting Trials – Artificial Intelligence) é uma nova diretriz para relatórios de ensaios clínicos que avaliam intervenções com um componente de IA. Ela foi desenvolvida em paralelo à sua declaração complementar para protocolos de ensaios clínicos, a SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials – Artificial Intelligence). Ambas as diretrizes foram desenvolvidas por meio de um processo de consenso em etapas que incluiu revisão da literatura e consultas a especialistas para gerar 29 itens candidatos. Foram feitas consultas sobre esses itens a um grupo internacional composto por 103 interessados diretos, que participaram de uma pesquisa Delphi em duas etapas. Chegou-se a um acordo sobre os itens em uma reunião de consenso que incluiu 31 interessados diretos, e os itens foram refinados por meio de uma lista de verificação piloto que envolveu 34 participantes. A extensão CONSORT-AI inclui 14 itens novos que, devido à sua importância para as intervenções de IA, devem ser informados rotineiramente juntamente com os itens básicos da CONSORT 2010. A CONSORT-AI preconiza que os pesquisadores descrevam claramente a intervenção de IA, incluindo instruções e as habilidades necessárias para seu uso, o contexto no qual a intervenção de IA está inserida, considerações sobre o manuseio dos dados de entrada e saída da intervenção de IA, a interação humano-IA e uma análise dos casos de erro. A CONSORT-AI ajudará a promover a transparência e a integralidade nos relatórios de ensaios clínicos com intervenções que utilizam IA. Seu uso ajudará editores e revisores, bem como leitores em geral, a entender, interpretar e avaliar criticamente a qualidade do desenho do ensaio clínico e o risco de viés nos resultados relatados.

https://doi.org/10.26633/rpsp.2024.13

Directrices para los protocolos de ensayos clínicos de intervenciones con inteligencia artificial: la extensión SPIRIT-AI
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Cruz Rivera, Samantha

; Liu, Xiaoxuan

; Chan, An-Wen

; Denniston, Alastair K.

; Calvert, Melanie J.

; Denniston, Alastair K.

; Chan, An-Wen

; Darzi, Ara

; Holmes, Christopher

; Yau, Christopher

; Moher, David

; Ashrafian, Hutan

; Deeks, Jonathan J.

; Ferrante di Ruffano, Lavinia

; Faes, Livia

; Calvert, Melanie J.

; Keane, Pearse A.

; Cruz Rivera, Samantha

; Vollmer, Sebastian J.

; Liu, Xiaoxuan

; Lee, Aaron Y.

; Jonas, Adrian

; Esteva, Andre

; Beam, Andrew L.

; Chan, An-Wen

; Panico, Maria Beatrice

; Lee, Cecilia S.

; Haug, Charlotte

; Kelly, Christophe J.

; Yau, Christopher

; Mulrow, Cynthia

; Espinoza, Cyrus

; Fletcher, John

; Moher, David

; Paltoo, Dina

; Manna, Elaine

; Price, Gary

; Collins, Gary S.

; Harvey, Hugh

; Matcham, James

; Monteiro, Joao

; Khair ElZarrad, M.

; Ferrante di Ruffano, Lavinia

; Oakden-Rayner, Luke

; Calvert, Melanie J.

; McCradden, Melissa

; Keane, Pearse A.

; Savage, Richard

; Golub, Robert

; Sarkar, Rupa

; Rowley, Samuel

Revista Panamericana de Salud Pública

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2023, Volume 47 elocation e149

Abstract: Es En Pt | Text: Es En Pt | PDF: Es | PDF: En | PDF: Pt

resumen está disponible en el texto completo

https://doi.org/10.26633/rpsp.2023.149

A declaração PRISMA 2020: diretriz atualizada para relatar revisões sistemáticas
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Page, Matthew J.

; McKenzie, Joanne E.

; Bossuyt, Patrick M.

; Boutron, Isabelle

; Hoffmann, Tammy C.

; Mulrow, Cynthia D.

; Shamseer, Larissa

; Tetzlaff, Jennifer M.

; Akl, Elie A.

; Brennan, Sue E.

; Chou, Roger

; Glanville, Julie

; Grimshaw, Jeremy M.

; Hróbjartsson, Asbjørn

; Lalu, Manoj M.

; Li, Tianjing

; Loder, Elizabeth W.

; Mayo-Wilson, Evan

; McDonald, Steve

; McGuinness, Luke A.

; Stewart, Lesley A.

; Thomas, James

; Tricco, Andrea C.

; Welch, Vivian A.

; Whiting, Penny

; Moher, David

Revista Panamericana de Salud Pública

Journal Metrics
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2022, Volume 46 elocation e112

Abstract: En Pt Es | Text: En Pt Es | PDF: En | PDF: Pt | PDF: Es

ABSTRACT The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.

RESUMO A declaração dos Principais Itens para Relatar Revisões Sistemáticas e Meta-análises (PRISMA), publicada em 2009, foi desenvolvida para ajudar revisores sistemáticos a relatar de forma transparente por que a revisão foi feita, os métodos empregados e o que os autores encontraram. Na última década, os avanços na metodologia e terminologia de revisões sistemáticas exigiram a atualização da diretriz. A declaração PRISMA 2020 substitui a declaração de 2009 e inclui novas orientações para relato que refletem os avanços nos métodos para identificar, selecionar, avaliar e sintetizar estudos. A estrutura e apresentação dos itens foram modificadas para facilitar a implementação. Neste artigo, apresentamos a lista de checagem PRISMA 2020 de 27 itens, uma lista de checagem expandida que detalha as recomendações para relato para cada item, a lista de checagem PRISMA 2020 para resumos e os fluxogramas revisados para novas revisões e para atualização de revisões.

RESUMEN La declaración PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses), publicada en 2009, se diseñó para ayudar a los autores de revisiones sistemáticas a documentar de manera transparente el porqué de la revisión, qué hicieron los autores y qué encontraron. Durante la última década, ha habido muchos avances en la metodología y terminología de las revisiones sistemáticas, lo que ha requerido una actualización de esta guía. La declaración PRISMA 2020 sustituye a la declaración de 2009 e incluye una nueva guía de presentación de las publicaciones que refleja los avances en los métodos para identificar, seleccionar, evaluar y sintetizar estudios. La estructura y la presentación de los ítems ha sido modificada para facilitar su implementación. En este artículo, presentamos la lista de verificación PRISMA 2020 con 27 ítems, y una lista de verificación ampliada que detalla las recomendaciones en la publicación de cada ítem, la lista de verificación del resumen estructurado PRISMA 2020 y el diagrama de flujo revisado para revisiones sistemáticas.

https://doi.org/10.26633/rpsp.2022.112

Apoyo a las guías de publicación para estudios de evaluación económica por parte de las revistas biomédicas españolas
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Catalá-López, Ferrán

; Ridao, Manuel

; Bernal-Delgado, Enrique

; Moher, David

; Repullo, José R.

Gaceta Sanitaria

Journal Metrics
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jun 2019, Volume 33 N. 3 Pages 255 - 258

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

ABSTRACT Objective To examine the endorsement of reporting guidelines for economic evaluation studies, such as the CHEERS(Consolidated Health Economic Evaluation Reporting Standards)statement, by Spanish biomedical journals. Method Cross-sectional analysis of the instructions to authors of Spanish biomedical journals included in the Journal Citation Reports 2017. Two authors examined and extracted the following information: mention of any reporting guideline, the CHEERS statement, the recommendations of the International Committee of Medical Journal Directors (ICMJE) and theEnhancing the QUAlity and Transparency Of health Research(EQUATOR) network. Results Of the 28 journals included, 23 (82.1%; 95% confidence interval [95%CI]: 63.1-93.9%) mentioned at least one reporting guideline in the instructions to authors. Only one journal mentioned the CHEERS statement for health economic evaluations. Twenty-four journals (85.7%; 95%CI: 67.3-96.0%) mentioned the ICMJE recommendations and 8 (28.6%; 95%CI: 13.2-48.7%) mentioned the EQUATOR network. The CONSORT(Consolidated Standards of Reporting Trials)statement for clinical trials was the most- mentioned reporting guideline (n=21; 75.0%; 95%CI: 55.1-89.3%). Discussion Most of the instructions to authors do not provide guidance on how to report economic evaluations. Journals should support compliance with reporting guidelines by authors and peer-reviewers.

RESUMEN Objetivo Examinar el apoyo a las guías de publicación para estudios de evaluación económica, como la declaración CHEERS(Consolidated Health Economic Evaluation Reporting Standards),por parte de las revistas biomédicas españolas. Método Análisis transversal de las normas de autoría de las revistas biomédicas españolas incluidas en Journal Citation Reports 2017. Dos autores examinaron y extrajeron la siguiente información: mención de alguna guía de publicación, declaración CHEERS, recomendaciones del International Committee of Medical Journal Editors (ICMJE) e iniciativaEnhancing the QUAlity and Transparency Of health Research(EQUATOR). Resultados De las 28 revistas incluidas, 23 (82,1%; intervalo de confianza del 95% [IC95%]: 63,1-93,9%) mencionaron alguna guía. Una única revista mencionó la declaración CHEERS para estudios de evaluación económica. Veinticuatro revistas (85,7%; IC95%: 67,3-96,0%) mencionaron las recomendaciones del ICMJE y 8 (28,6%; IC95%: 13,2-48,7%) la red EQUATOR. La declaración CONSORT(Consolidated Standards of Reporting Trials)para ensayos clínicos fue la guía más mencionada (n=21; 75,0%; IC95%: 55,1-89,3%). Discusión La mayoría de las normas de autoría no incorporan información sobre cómo presentar evaluaciones económicas. Las revistas deberían apoyar el cumplimiento de las guías de publicación por parte de las personas autoras y revisoras.

https://doi.org/10.1016/j.gaceta.2018.12.006

Apoyo a las guías de publicación para estudios de evaluación económica por parte de las revistas biomédicas españolas
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Catalá-López, Ferrán

; Ridao, Manuel

; Bernal-Delgado, Enrique

; Moher, David

; Repullo, José R.

Gaceta Sanitaria

Journal Metrics
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jun 2019, Volume 33 N. 3 Pages 255 - 258

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

https://doi.org/10.1016/j.gaceta.2018.12.006 152 downloads

Research Reporting Guidelines in Dentistry: A Survey of Editors
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Sarkis-Onofre, Rafael

; Cenci, Maximiliano Sérgio

; Moher, David

; Pereira-Cenci, Tatiana

Brazilian Dental Journal

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feb 2017, Volume 28 N. 1 Pages 3 - 8

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

Resumo O uso de guias de reporte tem um papel importante no desenvolvimento das pesquisas na saúde, melhorando a qualidade e a precisão das publicações. Esse estudo avaliou como periódicos de odontologia usam os guias de reporte. Todos editores de periódicos de odontologia registrados na lista do 2013 Journal of Citation Reports (n=81) foram convidados a participar. Dados foram coletados através de um questionário online autoaplicável. Informações sobre o perfil do periódico/editor e do uso de guias de reporte pelos periódicos foram coletados. Informações/recomendações sobre o uso de guias de reporte foram também coletados dos sites de todos os periódicos. Dados foram analisados descritivamente e frequências foram sumarizadas. Trinta e quatro (42%) editores completaram o questionário. Maioria dos periódicos é membro do Committee on Publication Ethics (64,7%) e/ou seguem as recomendações do International Committee of Medical Journal Editors (20,6%), enquanto 26,5% dos periódicos não são membros de nenhum grupo editorial. A maioria dos editores não é familiar com o EQUATOR Network (55,9%), não trabalha em tempo integral como editor (85,3%) e 88,2% recebem algum pagamento. A maioria deles recebeu treinamento para a posição de editor (55,9%). O CONSORT Statement foi endossado por 61,8% dos periódicos. Informações oriundas dos sites demonstraram que 44,4% dos periódicos não recomendam nenhum guia de reporte, 51,9% mencionam o CONSORT Statement no site e 28,4 apenas recomenda o CONSORT Statement. Existe um espaço claro para melhora no uso de guias de reporte em periódicos de odontologia. Um maior entendimento e endosso/aderência/implementação de guias de reporte por periódicos de odontologia pode promover a qualidade e transparência das pesquisas odontológicas publicadas.

Abstract The use of reporting guidelines has an important role in the development of health research, improving the quality and precision of the publications. This study evaluated how dental journals use reporting guidelines. All editors of dental journals registered on the 2013 Journal Citation Reports list (n=81) were invited to participate. The data were collected by a self-reported web-based questionnaire. Information about the profile of journal/editor and on the use of reporting guidelines by journals was gathered. Information/recommendations about the use of reporting guidelines were collected from the websites of all journals. Data were descriptively analyzed and frequencies were summarized. Thirty-four (42%) editors completed the questionnaire. Most journals are members of Committee on Publication Ethics (64.7%) and/or follow the International Committee of Medical Journal Editors recommendations (20.6%), while 26.5% are not members of any editorial group. Most editors are unfamiliar with the EQUATOR Network (55.9%), do not work full time (85.3%) and 88.2% have some income/payment. Most of them received educational training for this position (55.9%). The CONSORT Statement was endorsed by 61.8% of journals. Information from websites showed that 44.4% journals do not recommend any reporting guideline, 51.9% mention CONSORT Statement in the website and 28.4% only recommend the use of CONSORT Statement. There is clearly room for improving the use of reporting guidelines in dental journals. Broadening the understanding and the endorsement/adherence/implementation of reporting guidelines by journals may promote quality and transparence of published dental research.

https://doi.org/10.1590/0103-6440201601426 1431 downloads

Ítems de referencia para publicar Protocolos de Revisiones Sistemáticas y Metaanálisis: declaración PRISMA-P 2015
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Moher, David

; Shamseer, Larissa

; Clarke, Mike

; Ghersi, Davina

; Liberati, Alessandro

; Petticrew, Mark

; Shekelle, Paul

; Stewart, Lesley A

Revista Española de Nutrición Humana y Dietética

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jun 2016, Volume 20 N. 2 Pages 148 - 160

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.

Las revisiones sistemáticas deben establecerse sobre la base de un protocolo que describa la justificación, la hipótesis y los métodos planificados de la revisión, antes de su realización o publicación; sin embargo pocas revisiones publicadas informan sobre la existencia previa de un protocolo. Disponer de un protocolo detallado y bien escrito puede facilitar la comprensión y valoración de la metodología de la revisión, así como la detección de modificaciones en la metodología o la publicación selectiva en revisiones completadas. El presente trabajo describe el desarrollo de unas directrices de presentación de la información, Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols 2015 (PRISMA-P 2015). Las directrices PRISMA-P se componen de una lista de verificación de 17 elementos que pretenden facilitar la preparación y presentación de un protocolo sólido para la revisión sistemática. Las instituciones financiadoras y quienes encargan las revisiones podrían considerar la posibilidad de exigir la lista de verificación, a fin de facilitar la presentación de la información relevante del protocolo, para solicitar financiación. De forma similar, los revisores por pares y editores pueden utilizar las directrices para determinar la integridad y transparencia de un protocolo de revisión sistemática presentado a una revista u otro medio para su publicación.

https://doi.org/10.14306/renhyd.20.2.223 11213 downloads

SPIRIT 2013 Statement: defining standard protocol items for clinical trials
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Chan, An-Wen

; Tetzlaff, Jennifer M.

; Altman, Douglas G.

; Laupacis, Andreas

; Gøtzsche, Peter C.

; Krleža-Jerić, Karmela

; Hrobjartsson, Asbjørn

; Mann, Howard

; Dickersin, Kay

; Berlin, Jesse A.

; Dore, Caroline J.

; Parulekar, Wendy R.

; Summerskill, William S.M.

; Groves, Trish

; Schulz, Kenneth F.

; Sox, Harold C.

; Rockhold, Frank W.

; Rennie, Drummond

; Moher, David

Revista Panamericana de Salud Pública

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dec 2015, Volume 38 N. 6 Pages 506 - 514

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

El protocolo de un ensayo clínico es la base para planificar, ejecutar, publicar y evaluar el ensayo. Sin embargo, los protocolos y las guías que existen para su elaboración varían enormemente en cuanto a su calidad y contenido. En este artículo se describe la elaboración sistemática y el alcance de la Declaración SPIRIT 2013 (denominada así por la sigla en inglés de Standard Protocol items: Recommendations for Interventional Trials o Elementos estándares de un protocolo: recomendaciones para los ensayos de intervención), una guía en la que se establecen los contenidos mínimos que debe tener el protocolo de un ensayo clínico. La lista de comprobación de la declaración SPIRIT, que consta de 33 elementos, se aplica a los protocolos de todos los ensayos clínicos y se centra más en el contenido que en el formato. En esta lista se recomienda hacer una descripción completa de lo que se ha planificado, aunque no se establece cómo diseñar o ejecutar un ensayo. Al brindar orientación sobre los contenidos fundamentales, las recomendaciones SPIRIT procuran facilitar la redacción de protocolos de alta calidad. El cumplimiento de las recomendaciones SPIRIT debería mejorar la transparencia y la exhaustividad de los protocolos de los ensayos en beneficio de los investigadores, los participantes, los pacientes, los patrocinadores, los financiadores, los comités de ética de la investigación o las juntas de revisión institucionales, los revisores, las revistas biomédicas, los registros de ensayos, los formuladores de políticas, los organismos reguladores y otras partes interesadas clave.

947 downloads

10.

Declaración de trasparencia: promoviendo una publicación más completa, honesta y adecuada de los artículos cientítificos
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Catalá-López, Ferrán

; Peiró, Salvador

; Hutton, Brian

; Pérez Andrés, Cristina

; Moher, David

Revista Española de Salud Pública

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apr 2014, Volume 88 N. 2 Pages 181 - 186

Abstract: Es | Text: Es | PDF: Es

455 downloads

11.

Declaración de trasparencia: promoviendo una publicación más completa, honesta y adecuada de los artículos cientítificos
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Catalá-López, Ferrán

; Peiró, Salvador

; Hutton, Brian

; Pérez Andrés, Cristina

; Moher, David

Revista Española de Salud Pública

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apr 2014, Volume 88 N. 2 Pages 181 - 186

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

998 downloads

12.

Extensión PRISMA-Equidad 2012: guías para la escritura y la publicación de revisiones sistemáticas enfocadas en la equidad en salud
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Welch, Vivian

; Petticrew, Mark

; Tugwell, Peter

; Moher, David

; O'Neill, Jennifer

; Waters, Elizabeth

; White, Howard

Revista Panamericana de Salud Pública

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jul 2013, Volume 34 N. 1 Pages 60 - 67

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

There is a global imperative to tackle national and international health inequities- defined as unfair and avoidable differences in health. One step in reaching this goal is to improve the rigorous, scientific evidence base on the impacts of policies on inequities in health outcomes, resource allocation, and use. Systematic reviews are increasingly recognized as a valuable source of evidence for both health care and health systems decision making, yet very few systematic reviews report effects on health equity. We developed consensus-based reporting guidelines for equity-focused systematic reviews in order to help reviewers identify, extract, and synthesise evidence on equity in systematic reviews. Increased use of these reporting guidelines will help improve the reporting of effects on both inequities in health outcomes and health care use across gender, socioeconomic position, and other characteristics, both in systematic reviews and eventually primary research, thus contributing to the global agenda to improve health equity.

Existe un imperativo mundial de abordar las desigualdades sanitarias a nivel nacional e internacional, definidas como diferencias en la salud injustas y evitables. Un paso hacia lograr esta meta es mejorar la base de evidencia científica rigurosa relacionada con las repercusiones de las políticas sobre las desigualdades en los resultados de la salud, la asignación de recursos y su uso. Las revisiones sistemáticas son cada vez más reconocidas como fuente de evidencia valiosa para la toma de decisiones relacionadas con la atención sanitaria y los sistemas sanitarios; sin embargo, muy pocas revisiones sistemáticas informan acerca de los efectos sobre la equidad en salud. Desarrollamos guías consensuadas para la escritura y publicación de revisiones sistemáticas centradas en la equidad, para ayudar a que los revisores identifiquen, extraigan y sinteticen la evidencia sobre la equidad en las revisiones sistemáticas. El uso cada vez mayor de estas guías para escribir y publicar trabajos científicos ayudará a mejorar los informes de los efectos sobre las desigualdades en los resultados de la salud y el uso de la atención sanitaria según el género, la posición socioeconómica y otras características, tanto en las revisiones sistemáticas como, en última instancia, en la investigación primaria, y en consecuencia contribuirá a la agenda mundial para optimizar la equidad en salud.

4632 downloads Cited 1 time in SciELO

13.

Mejora de la calidad de los informes de los metaanálisis de los ensayos clínicos controlados: el acuerdo QUOROM
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Moher, David

; Cook, Deborah J

; Eastwood, Susan

; Olkin, Ingram

; Rennie, Drummond

; Stroup, Donna F

Revista Española de Salud Pública

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apr 2000, Volume 74 N. 2

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

BACKGROUND: The Quality of Reporting of Meta-analyses (QUOROM) Conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs). METHODS: The QUOROM group consists of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items. RESULTS: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta- analysis. it is organized into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with 'trial flow', study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials. INTERPRETATION We hope this report will generate further thought about ways to improve the quality of reports of meta- analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement.

La Conferencia sobre Calidad de Elaboración de los Informes de los Metaanálisis (QUOROM) se convocó con el fin de abordar la mejora de la calidad de la elaboración de los informes de los metaanálisis de los ensayos clínicos controlados (ECC). El Grupo QUOROM estuvo integrado por 30 personas, entre epidemiólogos clínicos, estadísticos, editores e investigadores. Durante la conferencia se pidió al grupo que identificase aquellos elementos que, en su opinión, se deberían incluir en un protocolo de control de calidad por niveles. En la medida de lo posible, la elección de los elementos de dicho protocolo se guió por la evidencia científica, que sugería que el incumplimiento del elemento propuesto se podría traducir en resultados sesgados. Se utilizó una técnica Delphi modificada para valorar los elementos seleccionados a priori como parte del protocolo. La conferencia se tradujo en la declaración QUOROM, un protocolo de control de calidad y un diagrama de flujo. El protocolo de control de calidad describe la que creemos es la mejor forma de presentar el resumen, la introducción, los métodos, los resultados y la discusión del informe de un metaanálisis. Está organizada en 21 categorías y subcategorías relativas a búsquedas, selección, evaluación de la validez, análisis de los datos, características del estudio y síntesis de los datos cuantitativos, y en los resultados de "flujo de pruebas"; se identificó la documentación de la investigación con 18 elementos. El diagrama de flujo proporciona información tanto sobre el número de ensayos clínicos controlados identificados, incluidos y excluidos, como sobre las razones de su exclusión. Esperamos que este trabajo genere un mayor grado de reflexión sobre cómo mejorar la calidad de los informes de los metaanálisis de los ensayos clínicos controlados, y que los lectores, revisores, investigadores y editores utilicen la declaración QUOROM y generen ideas destinadas a su mejora.

9545 downloads Cited 1 time in SciELO

14.

Mejora de la calidad de los informes de los metaanálisis de los ensayos clínicos controlados: el acuerdo QUOROM
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Moher, David

; Cook, Deborah J

; Eastwood, Susan

; Olkin, Ingram

; Rennie, Drummond

; Stroup, Donna F

Revista Española de Salud Pública

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apr 2000, Volume 74 N. 2

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

1620 downloads Cited 1 time in SciELO

15.

Mejora de la calidad de los informes de los ensayos clínicos aleatorio controlados. Recomendaciones del grupo de trabajo CONSORT
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Begg, Colin

; Cho, Mildred

; Eastwood, Susan

; Horton, Richard

; Moher, David

; Olkin, Ingram

; Pitkin, Roy

; Rennie, Drummond

; Schulz, Kenneth F

; Simel, David

; Stroup, Donna F

Revista Española de Salud Pública

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jan 1998, Volume 72 N. 1 Pages 5 - 11

Abstract: En Es | Text: En Es | PDF: En | PDF: Es

This summary corresponds to the translation into Spanish of the Special Communication published in the Journal of the American Medical Association in August 1996, along with the editorial published in the same issue "How to report Randomized Controlled Trials. The Consort Statement". It describes the Consolidated Standars for Preparation of Controlled Clinical Trials, prepared by a work group made up of members of the SORT Group and of the Asilomar Work Group, along with the editor of a magazine and the author of the report on a clinical trial. The work was carried out by means of a Delphy process and the result was a check list and a process diagram. The check list is made up of 21 items that mainly refer to methods, results and discussions on the report of a controlled clinical trial, identifying the necessary information in order to be able to evaluate the internal and external value of the report, judging the improvement to be positive for the patient, the editors and the reviewers of the magazines.

Este trabajo corresponde a la traducción al español de la Colaboración Especial publicada en The Journal of the American Medical Association en agosto de 1996, junto con el editorial How to report Randomized Controlled Trials. The Consort Statement, publicada en el mismo número. En ella se describe la elaboración de las Normas Consolidadas para la elaboración de los Informes de los Ensayos Clínicos Controlados, por un grupo de trabajo formado por los componentes del grupo SORT y del Grupo de Trabajo Asilomar, junto con el director de una revista y el autor del informe de un ensayo clínico. El trabajo se realizó mediante un proceso Delphi y el resultado fue una lista de comprobación (checklist) y un diagrama de flujo. La primera está compuesta por 21 puntos que se refieren principalmente a los métodos, resultados y discusión del informe de un ensayo clínico controlado, identificándose la información necesaria para poder evaluar la validez interna y externa del ensayo, valorándose la mejora como positiva, tanto para los pacientes, como para los editores de las revistas y los revisores de las mismas.

3111 downloads Cited 3 times in SciELO

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