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1.
Int J Surg ; 88: 105918, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33789825

RESUMO

The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, first published in 2009 [1], was developed in an attempt to increase the clarity, transparency, quality and value of these reports [2]. The 27-item checklist and four-phase flow diagram have become the hallmark of academic rigour in the publication of systematic reviews and meta-analyses, having been cited by over 60,000 papers [3]. These are frequently endorsed by journals in their 'Instructions to Authors' [4]. Developments in the methodology and terminology used when conducting systematic reviews [5], alongside the identification of limitations responsible for poor adherence, such as the use of ambiguous wording [6], have warranted an update to the PRISMA statement. The PRISMA 2020 statement, therefore, is intended to reflect this recent evolution in the identification, selection, appraisal and synthesis of research [7]. Here, we present an interpretive analysis of the updated statement, with a view towards encouraging its adoption by both journals and authors in the pursuit of advancing evidence-based medicine.


Assuntos
Guias como Assunto , Relatório de Pesquisa/normas , Revisões Sistemáticas como Assunto , Lista de Checagem , Humanos , Editoração
2.
Int J Surg ; 88: 105906, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33789826

RESUMO

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.


Assuntos
Guias como Assunto , Relatório de Pesquisa/normas , Revisões Sistemáticas como Assunto , Lista de Checagem , Humanos , Editoração
4.
CMAJ Open ; 9(1): E295-E301, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33785477

RESUMO

BACKGROUND: The quality of case reports, which are often the first reported evidence for a disease, may be negatively affected by a rush to publication early in a pandemic. We aimed to determine the completeness of reporting (COR) for case reports published on coronavirus disease 2019 (COVID-19). METHODS: We conducted a systematic search of the PubMed database for all single-patient case reports of confirmed COVID-19 published from Jan. 1 to Apr. 24, 2020. All included case reports were assessed for adherence to the CARE (Case Report) 31-item checklist, which was used to create a composite COR score. The primary outcome was the mean COR score assessed by 2 independent raters. Secondary outcomes included whether there was a change in overall COR score with certain publication factors (e.g., publication date) and whether there was a linear relation between COR and citation count and between COR scores and social media attention. RESULTS: Our search identified 196 studies that were published in 114 unique journals. We found that the overall mean COR score was 54.4%. No one case report included all of the 31 CARE checklist items. There was no significant correlation between COR with either citation count or social media attention. INTERPRETATION: We found that the overall COR for case reports on COVID-19 was poor. We suggest that journals adopt common case-reporting standards to improve reporting quality.


Assuntos
COVID-19/epidemiologia , Lista de Checagem/normas , Editoração/normas , Relatório de Pesquisa/normas , Bibliografia de Medicina , Bibliometria , COVID-19/diagnóstico , COVID-19/virologia , Gerenciamento de Dados , Estudos Epidemiológicos , Ética , Fidelidade a Diretrizes , Humanos , Avaliação de Resultados em Cuidados de Saúde , Relatório de Pesquisa/tendências , SARS-CoV-2/genética , SARS-CoV-2/isolamento & purificação , Mídias Sociais/estatística & dados numéricos
5.
Mycopathologia ; 186(2): 155-162, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33704625

RESUMO

The 2020 COVID-19 pandemic had a profound impact on the publishing landscape. The 'pre-peer-review' publication model is likely to become common as a lag in publishing is not acceptable in a pandemic or other time! Mycopathologia is well placed to adopt such changes with its improved editorial processes, article formats, author engagements, and published articles' access and citation. Mycopathologia had an improved journal impact factor and article downloads in 2018-2019. A limited sampling suggested a slight decrease in the total submissions in 2019 (352 articles) compared to 2018 (371 articles). However, the acceptance rate improved to 30% in 2019 from 19% in 2018. Nearly half of all submissions in 2019 were rejected before peer-review or transferred to other Springer Nature journals. The published articles were contributed from 34 different countries, with authors from China, the USA, and Brazil among the top three contributors. An enhanced editorial oversight allowed peer-reviewers to focus on fewer articles that were well-matched to their expertise, which led to lower rejection rates post-peer-review. The introduction of MycopathologiaGENOME and MycopathologiaIMAGE article types received a good reception with notable downloads and citations.


Assuntos
COVID-19 , Micologia , Patologia , Revisão da Pesquisa por Pares/normas , Publicações Periódicas como Assunto/estatística & dados numéricos , Publicações Periódicas como Assunto/normas , Relatório de Pesquisa/normas , Guias como Assunto , Humanos , Fator de Impacto de Revistas , Pandemias , SARS-CoV-2
6.
Pharm. pract. (Granada, Internet) ; 19(1): 0-0, ene.-mar. 2021. tab
Artigo em Inglês | IBECS | ID: ibc-ET2-8306

RESUMO

Scholarly publishing is in a crisis, with the many stakeholders complaining about different aspects of the system. Authors want fast publication times, high visibility and publications in high-impact journals. Readers want freely accessible, high-quality articles. Peer reviewers want recognition for the work they perform to ensure the quality of the published articles. However, authors, peer reviewers, and readers are three different roles played by the same group of individuals, the users of the scholarly publishing system-and this system could work based on a collaborative publishing principle where "nobody pays, and nobody gets paid"


No disponible


Assuntos
Humanos , Autoria/normas , Pesquisa Biomédica/normas , Revisão por Pares/normas , Publicação de Acesso Aberto/normas , Comportamento Cooperativo , Publicações Periódicas como Assunto/normas , Relatório de Pesquisa/normas , Publicação Periódica , Sistemas de Avaliação das Publicações
8.
PLoS One ; 15(12): e0243091, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33326429

RESUMO

BACKGROUND: Systematic reviews with or without meta-analyses (SR/MAs) are strongly encouraged to work from a protocol to facilitate high quality, transparent methodology. The completeness of reporting of a protocol (PRISMA-P) and manuscript (PRISMA) is essential to the quality appraisal (AMSTAR-2) and appropriate use of SR/MAs in making treatment decisions. OBJECTIVES: The objectives of this study were to describe the completeness of reporting and quality of SR/MAs, assess the correlations between PRISMA-P, PRISMA, and AMSTAR-2, and to identify reporting characteristics between similar items of PRISMA-P and PRISMA. METHODS: We performed a systematic review of Type 2 Diabetes Mellitus SR/MAs of hypoglycemic agents with publicly available protocols. Cochrane reviews, guidelines, and specific types of MA were excluded. Two reviewers independently, (i) searched PubMed and Embase between 1/1/2015 to 20/3/2019; (ii) identified protocols of included studies by searching the manuscript bibliography, supplementary material, PROSPERO, and Google; (iii) completed PRISMA-P, PRISMA, and AMSTAR-2 tools. Data analysis included descriptive statistics, Pearson correlation, and multivariable linear regression. RESULTS: Of 357 relevant SR/MAs, 51 had available protocols and were included. The average score for PRISMA-P was 15.8±3.3 (66%; maximum 24) and 25.2±1.1 (93%; maximum 27) for PRISMA. The quality of SR/MAs assessed using the AMSTAR-2 tool identified an overall poor quality (63% critically low, 18% low, 8% moderate, 12% high). The correlation between the PRISMA-P and PRISMA was not significant (r = 0.264; p = 0.06). Correlation was significant between PRISMA-P and AMSTAR-2 (r = 0.333; p = 0.02) and PRISMA and AMSTAR-2 (r = 0.555; p<0.01). Discrepancies in reporting were common between similar PRISMA-P and PRISMA items. CONCLUSION: Adherence to protocol reporting guidance was poor while manuscript reporting was comprehensive. Protocol completeness is not associated with a completely reported manuscript. Independently, PRISMA-P and PRISMA scores were weakly associated with higher quality assessments but insufficient as a surrogate for quality. Critical areas for quality improvement include protocol description, investigating causes of heterogeneity, and the impact of risk of bias on the evidence synthesis.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Relatório de Pesquisa/normas , Revisões Sistemáticas como Assunto/normas , Viés , Fidelidade a Diretrizes , Humanos
9.
Gac. sanit. (Barc., Ed. impr.) ; 34(5): 521-523, sept.-oct. 2020. graf
Artigo em Espanhol | IBECS | ID: ibc-198877

RESUMO

Los recientes cambios en la normativa europea de protección de datos de carácter personal siguen permitiendo el uso de los datos sanitarios con fines de investigación, pero establecen la evaluación de impacto en protección de datos como instrumento de reflexión y análisis de riesgos en el proceso de tratamiento de datos. La publicación de una guía facilita la realización de esta evaluación de impacto, aunque no es de aplicación directa para los proyectos de investigación. Se detalla la experiencia en un proyecto concreto, y se muestra cómo el contexto del tratamiento toma relevancia respecto a las características de los datos. La realización de una evaluación de impacto es una oportunidad para asegurar el cumplimiento de los principios de la protección de datos en un entorno cada vez más complejo y con mayores desafíos éticos


Recent changes in European regulations for personal data protection still allow the use of health data for research purposes, but they have set the Impact Assessment on Data Protection as an instrument for reflection and risk analysis in the process of data processing. The publication of a guide for facilitates this impact assessment, although it is not directly applicable to research projects. Experience in a specific project is detailed, showing how the context of the treatment becomes relevant with respect to the data characteristics. Carrying out an impact assessment is an opportunity to ensure compliance with the principles of data protection in an increasingly complex environment with greater ethical challenges


Assuntos
Humanos , Segurança Computacional/tendências , Pesquisa Biomédica/métodos , Relatório de Pesquisa/normas , Ética em Pesquisa , Fator de Impacto , Anonimização de Dados/normas , Data Warehousing/normas
10.
Nat Med ; 26(9): 1364-1374, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32908283

RESUMO

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.


Assuntos
Inteligência Artificial , Revisão da Pesquisa por Pares/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa/normas , Humanos , Relatório de Pesquisa/normas
18.
Proc Natl Acad Sci U S A ; 117(24): 13386-13392, 2020 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-32487730

RESUMO

Clinical research should conform to high standards of ethical and scientific integrity, given that human lives are at stake. However, economic incentives can generate conflicts of interest for investigators, who may be inclined to withhold unfavorable results or even tamper with data in order to achieve desired outcomes. To shed light on the integrity of clinical trial results, this paper systematically analyzes the distribution of P values of primary outcomes for phase II and phase III drug trials reported to the ClinicalTrials.gov registry. First, we detect no bunching of results just above the classical 5% threshold for statistical significance. Second, a density-discontinuity test reveals an upward jump at the 5% threshold for phase III results by small industry sponsors. Third, we document a larger fraction of significant results in phase III compared to phase II. Linking trials across phases, we find that early favorable results increase the likelihood of continuing into the next phase. Once we take into account this selective continuation, we can explain almost completely the excess of significant results in phase III for trials conducted by large industry sponsors. For small industry sponsors, instead, part of the excess remains unexplained.


Assuntos
Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/normas , Relatório de Pesquisa/normas , Pesquisa Biomédica/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/economia , Humanos , Sistema de Registros , Apoio à Pesquisa como Assunto
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