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1.
Value Health ; 25(1): 10-31, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35031088

RESUMO

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces the previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, and the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as healthcare, public health, education, and social care). This Explanation and Elaboration Report presents the new CHEERS 2022 28-item checklist with recommendations and explanation and examples for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer-reviewed journals and the peer reviewers and editors assessing them for publication. Nevertheless, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, given that there is an increasing emphasis on transparency in decision making.


Assuntos
Pesquisa Biomédica/normas , Economia Médica/normas , Pesquisa Biomédica/economia , Lista de Checagem , Análise Custo-Benefício/normas , Feminino , Humanos , Revisão por Pares , Pesquisadores/normas , Participação dos Interessados
2.
Regul Toxicol Pharmacol ; 129: 105116, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35017023

RESUMO

Derisking is not a pharmaceutical industry strategy to reduce time, effort, or costs in drug development. Derisking strategies originated within the National Institutes of Health as a predicate to good science. There is a growing sentiment within drug development programs to diminish the importance of behavioral measures in toxicological studies and in the Tiered Safety assessment plans of the U.S. Regulatory Agencies and the International Commission on Harmonization. The validity and reliability of the Functional Observational Batter (FOB) is critically dependent on consistency and technical quality in each risk assessment plan. US Federal and International drug approval organizations have universally adopted the concept of principles of test construction rather than delineating specific behavioral assay endpoints for inclusion of the FOB in nonclinical safety protocols. The validity and reliability of behavioral observations in standardized neurotoxicity screening is critically dependent on the FOB developed by the Study Director with the Sponsor throughout all stages of testing.. The individual risk factors selected for observation to be included in the early Tier 1 safety program should be determined by the mechanism and mode of action of the test article. The results of Tier I testing are the basis for Tier II testing designs. Critical to the compliance with Good Laboratory Practices is the documentation of training of the operational staff scheduled to conduct all aspects of the established protocol.


Assuntos
Fármacos do Sistema Nervoso Central/efeitos adversos , Sistema Nervoso Central/efeitos dos fármacos , Avaliação Pré-Clínica de Medicamentos/normas , Síndromes Neurotóxicas/diagnóstico , Pesquisadores/normas , Animais , Desenvolvimento de Medicamentos , Humanos , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Pesquisadores/educação , Estados Unidos , United States Food and Drug Administration/normas
4.
Ann Surg ; 275(1): e264-e270, 2022 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-32224741

RESUMO

OBJECTIVE: To identify what strategies supervisors use to entrust autonomy during surgical procedures and to clarify the consequences of each strategy for a resident's level of autonomy. BACKGROUND: Entrusting autonomy is at the core of teaching and learning surgical procedures. The better the level of autonomy matches the learning needs of residents, the steeper their learning curves. However, entrusting too much autonomy endangers patient outcome, while entrusting too little autonomy results in expertise gaps at the end of training. Understanding how supervisors regulate autonomy during surgical procedures is essential to improve intraoperative learning without compromising patient outcome. METHODS: In an observational study, all the verbal and nonverbal interactions of 6 different supervisors and residents were captured by cameras. Using the iterative inductive process of conversational analysis, each supervisor initiative to guide the resident was identified, categorized, and analyzed to determine how supervisors affect autonomy of residents. RESULTS: In the end, all the 475 behaviors of supervisors to regulate autonomy in this study could be classified into 4 categories and nine strategies: I) Evaluate the progress of the procedure: inspection (1), request for information (2), and expressing their expert opinion (3); II) Influence decision-making: explore (4), suggest (5), or declare the next decision (6); III) Influence the manual ongoing action: adjust (7), or stop the resident's manual activity (8); IV) take over (9). CONCLUSIONS: This study provides new insights into how supervisors regulate autonomy in the operating room. This insight is useful toward analyzing whether supervisors meet learning needs of residents as effectively as possible.


Assuntos
Competência Clínica , Internato e Residência/métodos , Aprendizagem , Salas Cirúrgicas/normas , Autonomia Profissional , Pesquisadores/normas , Humanos , Estudos Retrospectivos
5.
FEBS J ; 289(2): 298-307, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33665964

RESUMO

Writing recommendation letters on behalf of students and other early-career researchers is an important mentoring task within academia. An effective recommendation letter describes key candidate qualities such as academic achievements, extracurricular activities, outstanding personality traits, participation in and dedication to a particular discipline, and the mentor's confidence in the candidate's abilities. In this Words of Advice, we provide guidance to researchers on composing constructive and supportive recommendation letters, including tips for structuring and providing specific and effective examples, while maintaining a balance in language and avoiding potential biases.


Assuntos
Tutoria/normas , Mentores/psicologia , Pesquisadores/normas , Humanos , Pesquisadores/educação , Redação
12.
PLoS One ; 16(11): e0257559, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34793439

RESUMO

BACKGROUND: Early career researchers face a hypercompetitive funding environment. To help identify effective intervention strategies for early career researchers, we examined whether first-time NIH R01 applicants who resubmitted their original, unfunded R01 application were more successful at obtaining any R01 funding within 3 and 5 years than original, unfunded applicants who submitted new NIH applications, and we examined whether underrepresented minority (URM) applicants differentially benefited from resubmission. Our observational study is consistent with an NIH working group's recommendations to develop interventions to encourage resubmission. METHODS AND FINDINGS: First-time applicants with US medical school academic faculty appointments who submitted an unfunded R01 application between 2000-2014 yielded 4,789 discussed and 7,019 not discussed applications. We then created comparable groups of first-time R01 applicants (resubmitted original R01 application or submitted new NIH applications) using optimal full matching that included applicant and application characteristics. Primary and subgroup analyses used generalized mixed models with obtaining any NIH R01 funding within 3 and 5 years as the two outcomes. A gamma sensitivity analysis was performed. URM applicants represented 11% and 12% of discussed and not discussed applications, respectively. First-time R01 applicants resubmitting their original, unfunded R01 application were more successful obtaining R01 funding within 3 and 5 years than applicants submitting new applications-for both discussed and not discussed applications: discussed within 3 years (OR 4.17 [95 CI 3.53, 4.93]) and 5 years (3.33 [2.82-3.92]); and not discussed within 3 years (2.81 [2.52, 3.13]) and 5 years (2.47 [2.22-2.74]). URM applicants additionally benefited within 5 years for not discussed applications. CONCLUSIONS: Encouraging early career researchers applying as faculty at a school of medicine to resubmit R01 applications is a promising potential modifiable factor and intervention strategy. First-time R01 applicants who resubmitted their original, unfunded R01 application had log-odds of obtaining downstream R01 funding within 3 and 5 years 2-4 times higher than applicants who did not resubmit their original application and submitted new NIH applications instead. Findings held for both discussed and not discussed applications.


Assuntos
Pesquisa Biomédica/normas , Escolha da Profissão , Educação Médica/normas , Pesquisadores/normas , Adulto , Pesquisa Biomédica/economia , Pesquisa Biomédica/educação , Educação Médica/economia , Docentes de Medicina/normas , Feminino , Administração Financeira/economia , Humanos , Masculino , Pessoa de Meia-Idade , Grupos Minoritários , National Institutes of Health (U.S.) , Revisão por Pares , Pesquisadores/economia , Faculdades de Medicina/economia , Faculdades de Medicina/normas , Estados Unidos/epidemiologia
14.
Am J Hum Genet ; 108(10): 1813-1816, 2021 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-34626580

RESUMO

The use of approved nomenclature in publications is vital to enable effective scientific communication and is particularly crucial when discussing genes of clinical relevance. Here, we discuss several examples of cases where the failure of researchers to use a HUGO Gene Nomenclature Committee (HGNC)-approved symbol in publications has led to confusion between unrelated human genes in the literature. We also inform authors of the steps they can take to ensure that they use approved nomenclature in their manuscripts and discuss how referencing HGNC IDs can remove ambiguity when referring to genes that have previously been published with confusing alias symbols.


Assuntos
Bases de Dados Genéticas/normas , Genes/genética , Genoma Humano , Pesquisadores/normas , Terminologia como Assunto , Genômica , Humanos
16.
Elife ; 102021 09 23.
Artigo em Inglês | MEDLINE | ID: mdl-34554086

RESUMO

Universities and research institutions have to assess individuals when making decisions about hiring, promotion and tenure, but there are concerns that such assessments are overly reliant on metrics and proxy measures of research quality that overlook important factors such as academic rigor, data sharing and mentoring. These concerns have led to calls for universities and institutions to reform the methods they use to assess research and researchers. Here we present a new tool called SPACE that has been designed to help universities and institutions implement such reforms. The tool focuses on five core capabilities and can be used by universities and institutions at all stages of reform process.


Assuntos
Sucesso Acadêmico , Academias e Institutos , Docentes , Pesquisadores , Universidades , Academias e Institutos/organização & administração , Academias e Institutos/normas , Mobilidade Ocupacional , Docentes/organização & administração , Docentes/normas , Humanos , Cultura Organizacional , Seleção de Pessoal , Formulação de Políticas , Pesquisadores/organização & administração , Pesquisadores/normas
17.
Biol Futur ; 72(4): 395-407, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34554491

RESUMO

Scientific writing is an important skill in both academia and clinical practice. The skills for writing a strong scientific paper are necessary for researchers (comprising academic staff and health-care professionals). The process of a scientific research will be completed by reporting the obtained results in the form of a strong scholarly publication. Therefore, an insufficiency in scientific writing skills may lead to consequential rejections. This feature results in undesirable impact for their academic careers, promotions and credits. Although there are different types of papers, the original article is normally the outcome of experimental/epidemiological research. On the one hand, scientific writing is part of the curricula for many medical programs. On the other hand, not every physician may have adequate knowledge on formulating research results for publication adequately. Hence, the present review aimed to introduce the details of creating a strong original article for publication (especially for novice or early career researchers).


Assuntos
Projetos de Pesquisa/normas , Pesquisadores/normas , Mobilidade Ocupacional , Humanos , Pesquisadores/tendências , Redação/normas
20.
Nature ; 596(7873): 486, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34429543
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