Financiamiento en investigación en salud: obteniendo financiamiento. Consejos útiles para aumentar las chances de éxito. Parte 2 / Health research funding: obtaining grants. Tips to improve the success rate. Part 2

Esta es la segunda parte de un artículo sobre la búsqueda de financiamiento para un proyecto de investigación. Todo proyecto de investigación requiere una fuente de financiamiento para poder ser llevado adelante. La búsqueda de fondos es una tarea que lleva tiempo y esfuerzo con una baja tasa de éxito. Compartimos algunos consejos que podrían ayudar a aumentar esa tasa de éxito en relación con: 1) cómo reconocer la necesidad de búsqueda de una fuente de financiamiento externo, 2) de dónde provienen los fondos, 3) qué gastos se pueden financiar habitualmente con los fondos y 4) cómo mejorar la escritura y la presentación a una convocatoria. (AU)

This is the second part of our series on searching funds for a research plan. Every research proposal requires a source of funding to be carried out. Looking for funds is a time and effort consuming task with a low success rate. We share some tips that may help to improve that success rate related to (1) how to recognize the need of an external funding source, (2) where the funds are coming from, (3) what costs can be funded and (4) how to improve a proposal writing and submission. (AU)

Financiamiento en investigación: ¿qué necesito antes de comenzar a buscar una fuente de financiamiento?: parte 1 / Research funding: what do I need before I start looking for a funding source?: part 1

Esta es la primera parte de un artículo sobre la búsqueda de financiamiento para un proyecto de investigación. Esta entrega resume los principales ítems para tener en consideración a la hora de postularse a una convocatoria. Requerimientos del proceso: 1. Tiempo protegido. 2. Propuesta de investigación sólida. 3. Equipo calificado y con experiencia. 4. Definición y organización de actividades. 5. Cronograma de actividades. 6. Estimación de costos. (AU)

This is the first part of an article about finding funding for a research project. This delivery summarizes the main ítems to take into consideration when applying for a call. Process requirements: 1. Protected time. 2. Strong research proposal. 3. Qualified and experienced team. 4. Definition and organization of activities. 5. Schedule of activities. 6. Cost estimate. (AU)

Innovations in infertility: a comprehensive analysis of the ClinicalTrials.gov database.

OBJECTIVE: To characterize the interventional clinical trials in infertility and to assess whether trial location or industry sponsorship was associated with trial noncompletion. DESIGN: Retrospective review of trials registered with ClinicalTrials.gov. SETTING: None. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Descriptive statistics characterizing the attributes of the clinical trials including intervention type, topic, population, completion status, size, location, sponsor, and results. The effects of the sponsor and trial location on trial noncompletion were assessed via logistic regression. RESULT(S): In total, 505 trials initiated between 2010 and 2020 were included in our analysis. Drug interventions were the most commonly studied (45%); ovarian stimulation trials accounted for 27% of the studies. Live birth was tracked as an outcome by 20% of the studies; 3% of the trials included mental health outcomes. Few trials (15%) enrolled male participants. Only 11% of the trials reported results, and 4% of the trials reported the race or ethnicity of the participants. Most trials (82%) were conducted outside the United States. Overall, 18% of the trials were not completed, most often because of lack of accrual (47%). United States trials had over twice the odds of noncompletion in univariate analysis (odds ratio = 2.48, 95% confidence interval = [1.47, 4.17]); however, this relationship lost significance after adjusting for potential confounders (odds ratio = 0.95, 95% confidence interval = [0.42, 2.14]). Trial sponsorship was not associated with trial noncompletion. CONCLUSION(S): Infertility trials predominantly investigated drug interventions, particularly ovarian stimulation. Live birth was an infrequent outcome despite its relevance to patients. Clinical trials should aim to address the unmet needs in fertility care and be inclusive of underserved populations affected by infertility.

Risk-based centralized data monitoring of clinical trials at the time of COVID-19 pandemic.

OBJECTIVES: COVID-19 pandemic caused several alarming challenges for clinical trials. On-site source data verification (SDV) in the multicenter clinical trial became difficult due to travel ban and social distancing. For multicenter clinical trials, centralized data monitoring is an efficient and cost-effective method of data monitoring. Centralized data monitoring reduces the risk of COVID-19 infections and provides additional capabilities compared to on-site monitoring. The key steps for on-site monitoring include identifying key risk factors and thresholds for the risk factors, developing a monitoring plan, following up the risk factors, and providing a management plan to mitigate the risk. METHODS: For analysis purposes, we simulated data similar to our clinical trial data. We classified the data monitoring process into two groups, such as the Supervised analysis process, to follow each patient remotely by creating a dashboard and an Unsupervised analysis process to identify data discrepancy, data error, or data fraud. We conducted several risk-based statistical analysis techniques to avoid on-site source data verification to reduce time and cost, followed up with each patient remotely to maintain social distancing, and created a centralized data monitoring dashboard to ensure patient safety and maintain the data quality. CONCLUSION: Data monitoring in clinical trials is a mandatory process. A risk-based centralized data review process is cost-effective and helpful to ignore on-site data monitoring at the time of the pandemic. We summarized how different statistical methods could be implemented and explained in SAS to identify various data error or fabrication issues in multicenter clinical trials.

Is There a Replication Crisis in Medical Education Research?

Scholars are increasingly aware that studies-across many disciplines-cannot be replicated by independent researchers. Here, the authors describe how medical education research may be vulnerable to this "replication crisis," explain how researchers can act together to reduce risks, and discuss the positive steps that can increase confidence in research findings. Medical education research contributes to policy and influences practitioner behavior. Findings that cannot be replicated suggest that the original research was not credible. This risk raises the possibility that unhelpful or even harmful changes to medical education have been implemented as a result of research that appeared defensible but was not. By considering these risk factors, researchers can increase the likelihood that studies are generating credible results. The authors discuss and provide examples of 6 factors that may endanger the replicability of medical education research: (1) small sample sizes, (2) small effect sizes, (3) exploratory designs, (4) flexibility in design choices, analysis strategy, and outcome measures, (5) conflicts of interest, and (6) very active fields with many competing research teams. Importantly, medical education researchers can adopt techniques used successfully elsewhere to improve the rigor of their investigations. Researchers can improve their work through better planning in the development stage, carefully considering design choices, and using sensible data analysis. The wider medical education community can help by encouraging higher levels of collaboration among medical educators, by routinely evaluating existing educational innovations, and by raising the prestige of replication and collaborative medical education research. Medical education journals should adopt new approaches to publishing. As medical education research improves, so too will the quality of medical education and patient care.

Social Determinants of Health and Implementation Research: Lessons from the COVID-19 Pandemic.

During the past three decades, the world has experienced many clinical and public health challenges that require implementation of practices and policies informed by an understanding of social determinants of health and health inequities, but perhaps none as global and pervasive as the current COVID-19 pandemic. In the context of this special themed issue on Social Determinants of Health and Implementation Research: Three Decades of Progress and a Need for Convergence, we highlight the application of social determinants of health and implementation research on various aspects of the COVID-19 pandemic.

Relações de gênero na rede municipal de belo horizonte: formação docente continuada / Relaciones de género en la red municipal de belo horizonte: formación continuada / Gender relations in the municipal network of belo horizonte: continuous teacher training

RESUMO. Este texto apresenta o relato reflexivo do projeto de formação continuada docente na rede municipal de educação de Belo Horizonte, entre 2015 e 2018, no campo das relações de gênero. A parceria entre a Secretaria Municipal de Educação e a Pontifícia Universidade Católica de Minas Gerais promoveu as condições necessárias para a realização e integração das atividades acadêmicas de extensão, ensino e pesquisa nos níveis da graduação e pós-graduação. Apesar do contexto político nacional das ofensivas antigênero no campo educacional, a demanda por ações formativas partiu de docentes e gestores/as da educação ao se depararem com os impactos das assimetrias na aprendizagem entre meninas e meninos, bem como situações de violência de gênero na escola. À luz dos pressupostos teóricos pós- estruturalistas de gênero, a formação utiliza metodologias diversificadas como grupos de estudo, seminários, oficinas pedagógicas e estudos de caso em diferentes espaços da cidade como escolas, universidade e museus. A análise dos quatro anos do projeto revela a importância de uma abordagem interdisciplinar das relações de gênero e de caráter permanente, pois ações formativas isoladas têm se mostrado ineficazes.

RESUMEN. En este texto se presenta el informe de reflexión del proyecto de formación continua de profesores y profesoras de la Red Municipal de Educación de Belo Horizonte, entre 2015 y 2018, en el ámbito de las relaciones de género. La asociación entre el Departamento Municipal de Educación y la Pontificia Universidad Católica de Minas Gerais promovió las condiciones necesarias a la realización e integración de las actividades académicas de extensión, enseñanza e investigación en los niveles de licenciatura y posgrado. A pesar del contexto político nacional de las ofensivas de género en el ámbito educativo, la demanda de acciones de capacitación provino de los maestros y administradores de la educación cuando se enfrentaron a los impactos de las asimetrías en el aprendizaje entre niñas y niños, así como a situaciones de violencia de género en la escuela. A la luz de los supuestos teóricos postestructuralistas de género, la capacitación utiliza diversas metodologías como grupos de estudio, seminarios, talleres pedagógicos y estudios de caso en diferentes espacios de la ciudad como escuelas, universidades y museos. El análisis de los cuatro años del proyecto muestra la importancia de un enfoque interdisciplinario de las relaciones de género de carácter permanente, ya que las acciones formativas aisladas han demostrado ser ineficaces.

ABSTRACT. This text presents the reflective report of the project of continuous teacher training in the Municipal Education Network of Belo Horizonte, between 2015 and 2018, in the field of gender relations. Partnership between the Municipal Department of Education and the Pontifical Catholic University of Minas Gerais promoted the necessary conditions for the implementation and integration of academic activities of extension, education and research at undergraduate and graduate levels. Despite the national political context of gender offensives in the educational field, the demand for training actions came from teachers and education managers when they faced the impacts of asymmetries in learning between girls and boys, as well as situations of gender violence at school. In the light of the post-structuralist theoretical assumptions of gender, training uses diverse methodologies such as study groups, seminars, pedagogical workshops and case studies in different spaces of the city, such as schools, universities and museums. The analysis of the four years of the project revealed the importance of an interdisciplinary approach to gender relations of a permanent nature, since isolated training actions have proved ineffective.

Assessment of Trends in the Design, Accrual, and Completion of Trials Registered in ClinicalTrials.gov by Sponsor Type, 2000-2019.

Importance: ClinicalTrials.gov is a valuable resource that can be used to trace the state and nature of trials. Since its launch in 2000, more than 345 000 trials have been registered. Little is known about the characteristics and trends in clinical trials over time and how they differ by sponsor type. Objective: To assess trends in clinical trials registered in ClinicalTrials.gov over time and by sponsor type. Design, Setting, and Participants: This cross-sectional study included clinical trials (interventional studies) registered in ClinicalTrials.gov from January 1, 2000, through December 31, 2019. The trials were grouped by lead sponsor: National Institutes of Health (NIH) and other US government agencies, industry, and other sources (foundations, universities, hospitals, clinics, and others). A static version of the Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database was downloaded on January 1, 2020, for analysis. Main Outcomes and Measures: ClinicalTrials.gov registration fields, including overall status, phase, intervention, number of sites, use of masking and randomization, sample size, and time to study completion by start year and lead sponsor (organization that provided funding or support for a clinical study). Results: A total of 245 999 clinical trials (interventional studies) were started between 2000 and 2019, of which 135 144 (54.9%) were completed. Among completed trials, 5113 (3.8%) were sponsored by the NIH or a US government agency, 48 668 (36.0%) by industry, and 81 363 (60.2%) by other sources. Most trials were single center (61.3%), randomized (65.6%), and phase 1 to 2 (35.5%) or did not have a US Food and Drug Administration-defined phase (38.4%), with fewer drug trials being conducted over time. Sample sizes were small (median, 60; interquartile range [IQR], 30-160) and diminished over time. Trial median completion times varied by lead sponsor: 3.4 years (IQR, 1.9-5.0 years) for NIH- and US government-sponsored trials, 1.2 years (IQR, 0.5-2.4 years) for industry trials, and 2.1 years (IQR, 1.1-3.7) for trials sponsored by other sources. Conclusions and Relevance: The findings suggest that the composition and design of trials changed from 2000 to 2019 and differed substantially by sponsor type. Increased funding toward larger randomized clinical trials may be warranted to inform clinical decision-making and guide future research.

National Institutes of Health Research Plan on Rehabilitation: Analysis and Progress.

OBJECTIVE: To summarize the progress toward the National Institutes of Health (NIH) Research Plan on Rehabilitation goals and the methods by which tracking occurred. DESIGN: Each grant award was manually coded by NIH staff for research plan goals, type of science categories (eg, basic, applied, infrastructure, etc), and if applicable, training, and then validated by NIH institute and center (IC) experts. Data for years 2015 through 2017 were used to develop a coding algorithm to automatically code grants in 2018 for validation by NIH IC experts. Additional data for all years (2015-2018) were also analyzed to track changes and progress. SETTING: The research utilized administrative data from NIH Reporter and internal NIH databases. PARTICIPANTS: The data sample included research grants and programs funded from fiscal years 2015 through 2018. The year 2015 was considered a baseline year as the research plan was published in 2016. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The primary outcome measures were substantial growth in NIH funding and numbers of awards for rehabilitation research, across most research plan goals and types of science, as well as validation of an automatic algorithm for coding grants. RESULTS: Number of grants, funding dollars, funding mechanisms, patent data, scientific influence and translational science, research plan goals, and type of science categories were tracked across years (2015-2018). Algorithm validation is presented for 2018 data. CONCLUSIONS: NIH advanced the goals stated in the Research Plan on Rehabilitation, but gap areas remain. Though funding in this portfolio is growing, continued focus and participation by the field is needed to advance rehabilitation science.

Consumers use of quality cues for meat purchase: Research trends and future pathways.

This paper aims to explore the trends in the research design used for assessing important quality cues in the meat industry and determine the most important quality cues that consumers use in their purchasing decisions. A Journal Article Network Analysis and non-parametric comparative analyses were used to collate the studies and analyse their findings respectively. Results indicate a predominate use of point-of-purchase surveys to collect data and consumers' stated preference to evaluate the important quality cues. At an aggregated analytical level, the five most important quality cues (country of origin, food safety certification, price, production system and quality certification labels) are extrinsic and relate to credence attributes. However, different rankings of important quality cues are obtained at a disaggregated analytical level based on meat type. The paper proposes that exploring the interconnection between meat quality cues and how they influence consumers in different market segments based on the value proposition of the retailer as a foreseeable future research pathway.

Conditional Direction Dependence Analysis: Evaluating the Causal Direction of Effects in Linear Models with Interaction Terms.

Direction dependence analysis (DDA) makes use of higher than second moment information of variables (x and y) to detect potential confounding and to probe the causal direction of linear variable relations (i.e., whether x → y or y → x better approximates the underlying causal mechanism). The "true" predictor is assumed to be a continuous nonnormal exogenous variable. Existing methods compatible with DDA, however, are of limited use when the relation of a focal predictor and an outcome is affected by a moderator. This study presents a conditional direction dependence analysis (CDDA) framework which enables researchers to evaluate the causal direction of conditional regression effects. Monte-Carlo simulations were used to evaluate two different moderation scenarios: Study 1 evaluates the performance of CDDA tests when a moderator affects the strength of the causal effect x → y. Study 2 evaluates cases in which the causal direction itself (x → y vs y → x) depends on moderator values. Study 3 evaluates the robustness of DDA tests in the presence of functional model misspecifications. Results suggest that significance tests compatible with CDDA are suitable in both moderation scenarios, i.e., CDDA allows one to discern regions of a moderator in which the causal direction is uniquely identifiable. An empirical example is provided to illustrate the approach.

Research and Technological Advances Regarding the Study of the Spread of Antimicrobial Resistance Genes and Antimicrobial-Resistant Bacteria Related to Animal Husbandry.

The extensive use of antimicrobials in animal farms poses serious safety hazards to both the environment and public health, and this trend is likely to continue. Antimicrobial resistance genes (ARGs) are a class of emerging pollutants that are difficult to remove once introduced. Understanding the environmental transfer of antimicrobial-resistant bacteria (ARB) and ARGs is pivotal for creating control measures. In this review, we summarize the research progress on the spread and detection of ARB and ARG pollution related to animal husbandry. Molecular methods such as high-throughput sequencing have greatly enriched the information about ARB communities. However, it remains challenging to delineate mechanisms regarding ARG induction, transmission, and tempo-spatial changes in the whole process, from animal husbandry to multiple ecosystems. As a result, future research should be more focused on the mechanisms of ARG induction, transmission, and control. We also expect that future research will rely more heavily on metagenomic -analysis, metatranscriptomic sequencing, and multi-omics technologies.

The global forum on bioethics in research meeting, "ethics of alternative clinical trial designs and methods in low- and middle-income country research": emerging themes and outputs.

Alternative clinical trial designs and methods are increasingly being used in place of the conventional individually randomised controlled trial (RCT) in high-income and in low-income and middle-income country (LMIC) research. These approaches - including adaptive, cluster-randomised and stepped-wedge designs and controlled human infection models - offer a number of potential advantages, including being more efficient and making the clinical trial process more socially acceptable. However, these designs and methods are generally not familiar to researchers, research ethics committees and regulators and their ethical implications have not received sufficient international attention from the bioethics, research, and policymaking communities working together. The ethics of alternative clinical trial designs and methods in LMIC research was chosen as a topic for the 2017 Global Forum on Bioethics in Research (GFBR). The meeting opened a global dialogue about this emerging issue in research ethics and gave voice to the LMIC perspective. It identified the need to take a multidisciplinary approach and to develop capacity amongst researchers and research ethics committees and regulators to propose, review and regulate these novel designs and methods. Building skills and infrastructure will empower researchers to choose from a broad range of designs and methods and adopt the most scientifically suitable, efficient, ethical and context-appropriate of these. The need for capacity development is most pressing from the LMIC perspective, where limited resources create an urgency to seek the most efficient trial design and method. The aim of this paper is to encourage broad debate about this complex area of research. By opening up this debate, GFBR aims to promote the appropriate and ethical use of novel designs and methods so their full potential to address the health needs in LMICs can be realised.

Assessment of Prevention Research Measuring Leading Risk Factors and Causes of Mortality and Disability Supported by the US National Institutes of Health.

Importance: No studies to date have examined support by the National Institutes of Health (NIH) for primary and secondary prevention research in humans and related methods research that measures the leading risk factors or causes of death or disability as outcomes or exposures. Objective: To characterize NIH support for such research. Design and Setting: This serial cross-sectional study randomly sampled NIH grants and cooperative agreements funded during fiscal years 2012 through 2017. For awards with multiple subprojects, each was treated as a separate project. Study characteristics, outcomes, and exposures were coded from October 2015 through February 2019. Analyses weighted to reflect the sampling scheme were completed in March through June 2019. Using 2017 data from the Centers for Disease Control and Prevention and 2016 data from the Global Burden of Disease project, the leading risk factors and causes of death and disability in the United States were identified. Main Outcomes and Measures: The main outcome was the percentage of the NIH prevention research portfolio measuring a leading risk factor or cause of death or disability as an outcome or exposure. Results: A total of 11 082 research projects were coded. Only 25.9% (95% CI, 24.0%-27.8%) of prevention research projects measured a leading cause of death as an outcome or exposure, although these leading causes were associated with 74.0% of US mortality. Only 34.0% (95% CI, 32.2%-35.9%) measured a leading risk factor for death, although these risk factors were associated with 57.3% of mortality. Only 31.4% (95% CI, 29.6%-33.3%) measured a leading risk factor for disability-adjusted life-years lost, although these risk factors were associated with 42.1% of disability-adjusted life-years lost. Relatively few projects included a randomized clinical trial (24.6%; 95% CI, 22.5%-26.9%) or involved more than 1 leading cause (3.3%; 95% CI, 2.6%-4.1%) or risk factor (8.8%; 95% CI, 7.9%-9.8%). Conclusions and Relevance: In this cross-sectional study, the leading risk factors and causes of death and disability were underrepresented in the NIH prevention research portfolio relative to their burden. Because so much is already known about these risk factors and causes, and because randomized interventions play such a vital role in the development of clinical and public health guidelines, it appears that greater attention should be given to develop and test interventions that address these risk factors and causes, addressing multiple risk factors or causes when possible.