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1.
Zhonghua Liu Xing Bing Xue Za Zhi ; 41(12): 2160-2162, 2020 Dec 10.
Artigo em Chinês | MEDLINE | ID: mdl-33378832

RESUMO

Learning clinical research methods, we must master the essentials. Essentials are the theories, principles and methods that make a discipline a unique discipline, without which the discipline will no more exist. Essentials are those things that are long-lasting and reliable, those that address the most important issues, those that are most frequently used in practice, and those that normally should not be compromised. The core underlying theories of epidemiological research are causation and errors control. The essentials often have profound theoretical underpinnings and difficult to grasp. We will truly believe the theories and observe the principles only when we have truly grasped them.


Assuntos
Pesquisa Biomédica , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Humanos
5.
PLoS One ; 15(10): e0239598, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33002031

RESUMO

Scientific claims in biomedical research are typically derived from statistical analyses. However, misuse or misunderstanding of statistical procedures and results permeate the biomedical literature, affecting the validity of those claims. One approach journals have taken to address this issue is to enlist expert statistical reviewers. How many journals do this, how statistical review is incorporated, and how its value is perceived by editors is of interest. Here we report an expanded version of a survey conducted more than 20 years ago by Goodman and colleagues (1998) with the intention of characterizing contemporary statistical review policies at leading biomedical journals. We received eligible responses from 107 of 364 (28%) journals surveyed, across 57 fields, mostly from editors in chief. 34% (36/107) rarely or never use specialized statistical review, 34% (36/107) used it for 10-50% of their articles and 23% used it for all articles. These numbers have changed little since 1998 in spite of dramatically increased concern about research validity. The vast majority of editors regarded statistical review as having substantial incremental value beyond regular peer review and expressed comparatively little concern about the potential increase in reviewing time, cost, and difficulty identifying suitable statistical reviewers. Improved statistical education of researchers and different ways of employing statistical expertise are needed. Several proposals are discussed.


Assuntos
Publicações Periódicas como Assunto , Estatística como Assunto , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Pesquisa Biomédica/estatística & dados numéricos , Interpretação Estatística de Dados , Políticas Editoriais , Humanos , Revisão por Pares , Publicações Periódicas como Assunto/normas , Publicações Periódicas como Assunto/estatística & dados numéricos , Reprodutibilidade dos Testes , Estatística como Assunto/métodos , Estatística como Assunto/normas , Inquéritos e Questionários
7.
BMJ Open ; 10(10): e039326, 2020 10 29.
Artigo em Inglês | MEDLINE | ID: mdl-33122319

RESUMO

OBJECTIVE: Clinical trial data sharing has the potential to accelerate scientific progress, answer new lines of scientific inquiry, support reproducibility and prevent redundancy. Vivli, a non-profit organisation, operates a global platform for sharing of individual participant-level trial data and associated documents. Sharing of these data collected from each trial participant enables combining of these data to drive new scientific insights or assess reproducibility-not possible with the aggregate or summary data tables historically made available. We report on our initial experience including key metrics, lessons learned and how we see our role in the data sharing ecosystem. We also describe how Vivli is addressing the needs of the COVID-19 challenge through a new dedicated portal that provides a direct search function for COVID-19 studies, availability for fast-tracked request review and data sharing. DATA SUMMARY: The Vivli platform was established in 2018 and has partnered with 28 diverse members from industry, academic institutions, government platforms and non-profit foundations. Currently, 5400 trials representing 3.6 million participants are shared on the platform. From July 2018 to September 2020, Vivli received 201 requests. To date, 106 of 201 requests received approval, 5 have been declined, 27 withdrew and 27 are in the revision stage. CONCLUSIONS: The pandemic has only magnified the necessity for data sharing. If most data are shared and in a manner that allows interoperability, then we have hope of moving towards a cohesive scientific understanding more quickly not only for COVID-19 but also for all diseases. Conversely, if only isolated pockets of data are shared then society loses the opportunity to close vital gaps in our understanding of this rapidly evolving epidemic. This current challenge serves to highlight the value of data sharing platforms-critical enablers that help researchers build on prior knowledge.


Assuntos
Ensaios Clínicos como Assunto , Infecções por Coronavirus , Gerenciamento de Dados , Disseminação de Informação/métodos , Serviços de Informação , Pandemias , Pneumonia Viral , Saúde Pública/tendências , Betacoronavirus , Pesquisa Biomédica/métodos , Pesquisa Biomédica/estatística & dados numéricos , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Gerenciamento de Dados/métodos , Gerenciamento de Dados/organização & administração , Gerenciamento de Dados/tendências , Humanos , Serviços de Informação/organização & administração , Serviços de Informação/tendências , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Projetos de Pesquisa
8.
J Exp Med ; 217(11)2020 11 02.
Artigo em Inglês | MEDLINE | ID: mdl-33064151

RESUMO

Over the past 9 mo, with 34 million infections and 1 million deaths, the COVID-19 pandemic has levied a grisly toll. Some countries, through political will and social organization, have successfully reduced the number of infections and deaths, but the global scale of loss reflects the difficulty of translating these approaches in other countries. An effective SARS-CoV-2 vaccine presents a technological solution to the failure of social and political ones. Vaccines are, however, not a silver bullet, but a safe, cost-effective, and globally applicable tool that will require a substantial effort-cooperation, commitment, time, and funding-to be effective.


Assuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Imunogenicidade da Vacina , Pandemias/prevenção & controle , Pneumonia Viral/imunologia , Pneumonia Viral/prevenção & controle , Vacinas Virais/imunologia , Animais , Anticorpos Antivirais/imunologia , Pesquisa Biomédica/métodos , Infecções por Coronavirus/virologia , Interações entre Hospedeiro e Microrganismos/imunologia , Humanos , Pneumonia Viral/virologia , Vacinação
13.
PLoS Biol ; 18(8): e3000815, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32760062

RESUMO

Two illustrations integrate current knowledge about severe acute respiratory syndrome (SARS) coronaviruses and their life cycle. They have been widely used in education and outreach through free distribution as part of a coronavirus-related resource at Protein Data Bank (PDB)-101, the education portal of the RCSB PDB. Scientific sources for creation of the illustrations and examples of dissemination and response are presented.


Assuntos
Betacoronavirus/crescimento & desenvolvimento , Pesquisa Biomédica/educação , Infecções por Coronavirus/prevenção & controle , Bases de Dados de Proteínas , Medicina nas Artes , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Animais , Betacoronavirus/fisiologia , Pesquisa Biomédica/métodos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Apresentação de Dados , Humanos , Disseminação de Informação/métodos , Estágios do Ciclo de Vida , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , Mucosa Respiratória/virologia
14.
Health Psychol ; 39(9): 731-735, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32833474

RESUMO

This special issue showcases how investigators working in different areas of health behavior change are utilizing early phase studies to advance intervention development. Through the publication of design or protocol papers for currently funded Science of Behavior Change (SOBC) network projects, the special issue illustrates how investigative teams are implementing the experimental medicine approach to advance our understanding of the mechanisms of action that underlie behavior change interventions and, in turn, develop an evidence base that can inform future intervention design. Given that a goal of the experimental medicine approach is the accumulation of an evidence base regarding the links between intervention strategies and putative mechanisms of action, it is critical that this evidence base is readily accessible to investigators and practitioners. Therefore, each of the included articles describes how it is implementing the open-science approach within its study protocol to ensure rigor and reproducibility. Each article provides information about how to register an early phase experiment before study conduct and how to publicly deposit the data, metadata, and publications. The special issue includes 10 design and protocol articles and 2 commentaries on a diverse array of scientific areas and approaches to test mechanisms of action for health behavior change interventions. By disseminating how the National Institutes of Health SOBC Initiative has supported the conduct of early phase intervention studies implementing the experimental medicine and open science approaches, the special issue provides a substantive roadmap to other scientists for how to adopt these approaches. (PsycInfo Database Record (c) 2020 APA, all rights reserved).


Assuntos
Pesquisa Biomédica/métodos , Transtornos Mentais/diagnóstico , Humanos , Reprodutibilidade dos Testes
16.
Am J Trop Med Hyg ; 103(3): 976-985, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32748773

RESUMO

Gene drive technologies represent powerful tools to develop vector control strategies that will complement the current approaches to mitigate arthropod-borne infectious diseases. The characteristics of gene drive technologies have raised additional concerns to those for standard genetically engineered organisms. This generates a need for adaptive governance that has not been met yet because of the rapid rate of progress in gene drive research. For the eventual release of gene drive insects into wild populations, an international governance network would be helpful in guiding scientists, stakeholders, public opinion, and affected communities in its use. We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool. However, this is not likely to happen as it takes years to develop global accords, and some countries may choose to move ahead independently on the new technology.


Assuntos
Culicidae/genética , Tecnologia de Impulso Genético/legislação & jurisprudência , Cooperação Internacional/legislação & jurisprudência , Controle de Mosquitos/legislação & jurisprudência , Mosquitos Vetores/genética , Agricultura/ética , Agricultura/métodos , Animais , Animais Geneticamente Modificados , Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , Tecnologia de Impulso Genético/ética , Humanos , Controle de Mosquitos/organização & administração , Saúde Pública , Característica Quantitativa Herdável
19.
Health Psychol ; 39(9): 841-845, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32833485

RESUMO

The Science of Behavior Change Network (SOBC) offers a pragmatic "experimental medicine" approach for advancing mechanisms of change regarding behavior. The key promise of the SOBC is to facilitate more effective knowledge accumulation about not only whether behavior change occurs in response to an intervention, but also how and why behavior change occurs. This work is being advanced during a time of rapid evolution on scientific best practices, particularly "open science" practices, which at their core, seek to increase the trustworthiness of science. The purpose of this commentary is to facilitate a broader discussion on opportunities and challenges involved with conducting mechanistic science related to behavior change (i.e., SOBC) via open science practices. The 10 studies published in this special issue highlight the considerable complexity involved in a mechanistic science of behavior change. Conducting this type of science will require a rich, multifaceted "team science" approach that can match that level of complexity, while constantly striving toward being as straightforward or as simple as possible, no simpler. Effective open science practices, which involve the sharing of resources whenever possible, can facilitate this type of team science. Moving to this new future would benefit from careful shifts in our scientific culture and financial models toward better supporting team and open science. In addition, there is also need for continued advancements in methods and infrastructure that can support the inherent complexities involved in advancing a mechanistic science of behavior change. (PsycInfo Database Record (c) 2020 APA, all rights reserved).


Assuntos
Transtornos Mentais/terapia , Pesquisa Biomédica/métodos , Humanos
20.
Surg Endosc ; 34(10): 4225-4232, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32749615

RESUMO

BACKGROUND: Healthcare systems and general surgeons are being challenged by the current pandemic. The European Association for Endoscopic Surgery (EAES) aimed to evaluate surgeons' experiences and perspectives, to identify gaps in knowledge, to record shortcomings in resources and to register research priorities. METHODS: An ad hoc web-based survey of EAES members and affiliates was developed by the EAES Research Committee. The questionnaire consisted of 69 items divided into the following sections: (Ι) demographics, (II) institutional burdens and management strategies, and (III) analysis of resource, knowledge, and evidence gaps. Descriptive statistics were summarized as frequencies, medians, ranges,, and interquartile ranges, as appropriate. RESULTS: The survey took place between March 25th and April 16th with a total of 550 surgeons from 79 countries. Eighty-one percent had to postpone elective cases or suspend their practice and 35% assumed roles not related to their primary expertise. One-fourth of respondents reported having encountered abdominal pathologies in COVID-19-positive patients, most frequently acute appendicitis (47% of respondents). The effect of protective measures in surgical or endoscopic procedures on infected patients, the effect of endoscopic surgery on infected patients, and the infectivity of positive patients undergoing laparoscopic surgery were prioritized as knowledge gaps and research priorities. CONCLUSIONS: Perspectives and priorities of EAES members in the era of the pandemic are hereto summarized. Research evidence is urgently needed to effectively respond to challenges arisen from the pandemic.


Assuntos
Betacoronavirus , Pesquisa Biomédica , Infecções por Coronavirus , Endoscopia , Pandemias , Pneumonia Viral , Pesquisa Biomédica/métodos , Pesquisa Biomédica/organização & administração , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Europa (Continente) , Alocação de Recursos para a Atenção à Saúde/métodos , Alocação de Recursos para a Atenção à Saúde/estatística & dados numéricos , Humanos , Controle de Infecções/métodos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Padrões de Prática Médica/tendências , Sociedades Médicas , Cirurgiões , Inquéritos e Questionários
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