RESUMO
The purpose of this paper is to summarize current practices for the design and analysis of group-randomized trials involving cancer-related risk factors or outcomes and to offer recommendations to improve future trials. We searched for group-randomized trials involving cancer-related risk factors or outcomes that were published or online in peer-reviewed journals in 2011-15. During 2016-17, in Bethesda MD, we reviewed 123 articles from 76 journals to characterize their design and their methods for sample size estimation and data analysis. Only 66 (53.7%) of the articles reported appropriate methods for sample size estimation. Only 63 (51.2%) reported exclusively appropriate methods for analysis. These findings suggest that many investigators do not adequately attend to the methodological challenges inherent in group-randomized trials. These practices can lead to underpowered studies, to an inflated type 1 error rate, and to inferences that mislead readers. Investigators should work with biostatisticians or other methodologists familiar with these issues. Funders and editors should ensure careful methodological review of applications and manuscripts. Reviewers should ensure that studies are properly planned and analyzed. These steps are needed to improve the rigor and reproducibility of group-randomized trials. The Office of Disease Prevention (ODP) at the National Institutes of Health (NIH) has taken several steps to address these issues. ODP offers an online course on the design and analysis of group-randomized trials. ODP is working to increase the number of methodologists who serve on grant review panels. ODP has developed standard language for the Application Guide and the Review Criteria to draw investigators' attention to these issues. Finally, ODP has created a new Research Methods Resources website to help investigators, reviewers, and NIH staff better understand these issues.
Assuntos
National Institutes of Health (U.S.)/normas , Neoplasias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa/normas , Humanos , National Institutes of Health (U.S.)/organização & administração , Neoplasias/epidemiologia , Fatores de Risco , Estados UnidosRESUMO
OBJECTIVE: Publication science is the scholarly study of various aspects of the academic publishing process. Its applications to COVID-19 literature have been limited. Here, we describe COVID-19 submissions to, and resulting articles published by, the journal Public Health Reports (PHR), an important resource for US public health practice. METHODS: We reviewed PHR's COVID-19 submissions and articles published between March 27, 2020, and March 27, 2023. We coded each article for article type, author affiliation, the categories listed in PHR's call for COVID-19 papers, and the public health emergency preparedness and response capabilities from the Centers for Disease Control and Prevention (CDC). RESULTS: During the study period, PHR received 1545 COVID-19 submissions and published 190 of those articles in a collection, COVID-19 Response. The COVID-19 Response collection included 102 research articles, 29 case study/practice articles, and 24 commentaries. The corresponding author of more than half (52.1%; n = 99) of the articles was affiliated with academia. By the categories listed in PHR's call for COVID-19 papers, 51 articles addressed health disparities, 38 addressed public health surveillance, and 34 addressed COVID-19 vaccination. By the CDC public health emergency preparedness and response capabilities, 87 articles addressed public health surveillance and epidemiologic investigation, 38 addressed community preparedness, and 32 addressed community recovery. The percentage of articles focused on policy/law was higher early in the pandemic (2020-2021) than later (2022-2023) (9.5% vs <3.0%). During the latter period, articles largely focused on vaccination (12.8%) and contact tracing (10.6%). CONCLUSIONS: Articles published in PHR's COVID-19 Response collection covered a broad range of topics and were authored by contributors from diverse organizations. Our characterization of the COVID-19 output of a representative US public health practice journal can help academic publishing better address informational needs of public health responders.
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COVID-19 , Planejamento em Desastres , Humanos , COVID-19/epidemiologia , Saúde Pública , Vacinas contra COVID-19 , Pandemias/prevenção & controleRESUMO
OBJECTIVES: Public Health Reports (PHR), the official journal of the Office of the US Surgeon General and US Public Health Service, is the oldest public health journal in the United States. Considering its heritage through the eyes of its past editors in chief (EICs), many of whom have been influential public health figures, can provide a fresh point of view on US public health history, of which the journal has been an integral part. Here, we reconstruct the timeline of past PHR EICs and identify women among them. METHODS: We reconstructed the PHR EIC timeline by reviewing the journal's previous mastheads and its articles describing leadership transitions. For each EIC, we identified dates in office, concurrent job titles, key contributions, and other important developments. RESULTS: PHR had 25 EIC transitions in 109 years of its history, during which a single individual in charge of the journal could be identified. Only 5 identifiable EICs were women, who served as EIC for approximately one-quarter of the journal's traceable history (28 of 109 years). PHR's longest-serving EIC was a woman named Marian P. Tebben (1974-1994). CONCLUSIONS: PHR history revealed frequent EIC transitions and a low representation of women among its EICs. Mapping the timeline of past EICs of a historic public health journal can yield valuable insights into the workings of US public health, especially in the area of building a research evidence base.
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COVID-19 , Influenza Humana , Masculino , Humanos , Feminino , Estados Unidos/epidemiologia , Saúde Pública , Influenza Humana/epidemiologia , COVID-19/epidemiologia , Prática de Saúde PúblicaRESUMO
OBJECTIVE: Public Health Reports (PHR) is the oldest public health journal in the United States and has reported on viral epidemics since the 19th century. We describe the creation and analysis of a collection of historic PHR articles on emerging viral epidemics in the United States to inform public health response to COVID-19 and future epidemics. METHODS: We searched databases from 1878 through 2021 using custom search strings and conducted a manual search for articles published under previously used names for PHR. We evaluated all articles based on inclusion/exclusion criteria and coded the final list for virus/disease, article type, public health emergency preparedness and response capabilities from the Centers for Disease Control and Prevention (CDC), and PubMed citation count. RESULTS: We identified 349 relevant articles including 130 commentaries/reviews/editorials, 79 epidemiologic reports, 75 research articles, and 65 case study/practice articles. The collection focused on influenza (n = 244), COVID-19 (n = 75), dengue (n = 14), and other emerging viruses, such as Zika and Ebola (n = 25). The collection included 48 articles on health disparities/health of various disadvantaged populations, highlighting such disparities as race and ethnicity (n = 22), socioeconomic status (n = 17), and age (n = 15). When we categorized articles by CDC public health emergency preparedness and response capabilities, we found that 207 addressed surveillance and epidemiologic investigation, 36 addressed community preparedness, and 28 addressed medical countermeasure dispensing and administration. The articles addressing surveillance and epidemiologic investigation, nonpharmaceutical interventions, and community preparedness had the most PubMed citations (799, 334, and 308, respectively). CONCLUSIONS: PHR's historic articles on US emerging viral epidemics covered a range of virus/disease types, emergency preparedness and response capabilities, and contribution types and were widely cited in the scholarly literature. This publicly available and continuously updated collection is a valuable resource for pandemic planning and response.
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COVID-19 , Equidade em Saúde , Viroses , Infecção por Zika virus , Zika virus , Humanos , Estados Unidos/epidemiologia , Saúde Pública , COVID-19/epidemiologia , Pandemias/prevenção & controleRESUMO
The generation of new neurons in the olfactory bulb (OB) persists into adulthood and is a multistep process that includes proliferation, fate choice, migration, survival, and differentiation. Neural precursor cells destined to form olfactory interneurons arise in the subventricular zone (SVZ) and migrate along the rostral migratory stream (RMS) to the OB. Recently, some factors classically known from their effects on the vascular system have been found to influence different steps of adult neurogenesis. In the present study, we report a modulatory function for the vascular endothelial growth factor receptor-1 (VEGFR-1) in adult olfactory neurogenesis. We identified expression of VEGFR-1 in GFAP-positive cells within regions involved in neurogenesis of the adult mouse brain. To determine functions for VEGFR-1 in adult neurogenesis, we compared neural progenitor cell proliferation, migration, and differentiation from wild-type and VEGFR-1 signaling-deficient mice (Flt-1TK(-/-) mice). Our data show that VEGFR-1 signaling is involved in the regulation of proliferation of neuronal progenitor cells within the SVZ, migration along the RMS, and in neuronal differentiation and anatomical composition of interneuron subtypes within the OB. RMS migration in Flt-1TK(-/-) mice was altered mainly as a result of increased levels of its ligand VEGF-A, which results in an increased phosphorylation of VEGFR-2 in neuronal progenitor cells within the SVZ and the RMS. This study reveals that proper RMS migration is dependent on endogenous VEGF-A protein.
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Inibição de Migração Celular/fisiologia , Neurogênese/fisiologia , Neurônios/fisiologia , Bulbo Olfatório/fisiologia , Células-Tronco/fisiologia , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/fisiologia , Fatores Etários , Animais , Inibição de Migração Celular/genética , Inibidores do Crescimento/genética , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Camundongos Knockout , Neurogênese/genética , Neurônios/citologia , Neurônios/enzimologia , Bulbo Olfatório/citologia , Comunicação Parácrina/genética , Células-Tronco/citologia , Células-Tronco/enzimologia , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/deficiência , Receptor 1 de Fatores de Crescimento do Endotélio Vascular/genéticaAssuntos
COVID-19 , Racismo , Humanos , Autoria , COVID-19/epidemiologia , Saúde Pública , Fator de Impacto de Revistas , EditoraçãoAssuntos
COVID-19 , Equidade em Saúde , Racismo , Humanos , Fator de Impacto de Revistas , Saúde PúblicaRESUMO
The National Alzheimer's Project Act, signed into law in 2011, mandates a National Plan to Address Alzheimer's Disease that is updated annually. In the Plan, the term Alzheimer disease includes not only Alzheimer disease (AD) proper, but also several specified related dementias, namely, frontotemporal, Lewy body, vascular, and mixed dementia. In response to a specific action item in the 2012 National Plan, the National Institute of Neurological Disorders and Stroke, in collaboration with the National Institute on Aging, convened panels of experts and conducted a 2-day public conference to develop research priorities and timelines for addressing Alzheimer disease-related dementias (ADRD) in 5 topic areas: multiple etiology dementias, health disparities, Lewy body dementias including dementia with Lewy bodies and Parkinson disease dementia, frontotemporal dementia and related tauopathies, and vascular contributions to ADRD. By design, the product was up to 8 prioritized research recommendations in each topic area including estimated timelines from when work on a recommendation is started to completion or to full implementation of an ongoing activity, and recognition of shared research themes across recommendations. These included increased education and training of both researchers and health care professionals, addressing health disparities, fundamental neurobiology research, advanced diagnostics, collaborative biosample repositories, and a focus on developing effective interventions to prevent or treat ADRD by the year 2025 as targeted by the National Plan.
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Doença de Alzheimer , Demência , Humanos , Pesquisa , Estados UnidosRESUMO
Sox2 is an important transcriptional regulator in embryonic and adult stem cells. Recently, Sox2 was identified as an oncogene in many endodermal cancers, including colon cancer. There is great interest in how Sox2 cooperates with other transcription factors to regulate stem cell renewal, differentiation, and reprogramming. However, we still lack a general understanding of Sox2 transcriptional action. To determine transcriptional partners of Sox2 in adult cells, we generated mice where gene expression could be induced by an externally applied stimulus. We analyzed the consequences in the intestine where cell turnover is rapid. Sox2 expression, but not Oct4, specifically increased the numbers of stem cells and repressed Cdx2, a master regulator of endodermal identity. In vivo studies demonstrated that Sox21, another member of the SoxB gene family, was a specific, immediate, and cell-autonomous target of Sox2 in intestinal stem cells. In vitro experiments showed that Sox21 was sufficient to repress Cdx2 in colon cancer cells and in pluripotent stem cells. Sox21 was also specifically induced by Sox2 in fibroblasts and inhibition of Sox21 blocked reprogramming to the pluripotent state. These results show that transcriptional induction of Sox21 is a rapid and general mediator of the effects of Sox2 on cell identity in a wide range of cell types.