The study and improvement of data collection and management for infectious diseases and immunodeficiencies

传染病和免疫缺陷数据收集和管理的研究和改进

• 批准号: 10928000
• 负责人: Emily Ricotta
• 金额: $ 9.76万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10928000
• 关键词: Adopted; Attention; COVID-19 pandemic; Characteristics; Clinical; Clinical Research; Communicable Diseases; Community Health; Consensus; Data; Data Collection; Data Sources; Development; Disease; Disease Outbreaks; Ebola; Educational workshop; Elements; Epidemic; Epidemiologist; Ethicists; Ethics; Funding; Future; Goals; Health; Immune System Diseases; Immunologic Deficiency Syndromes; Influenza A Virus, H1N1 Subtype; Intervention; Legal; Libraries; Literature; Manuscripts; Medical; Medicine; Methods; Morbidity - disease rate; Nature; Outcome; Output; Participant; Peer Review; Policies; Population; Population Study; Protocols documentation; Public Health; Publications; Publishing; Recommendation; Reporting; Research; Research Design; Risk; Role; SARS coronavirus; Scientist; Series; Speed; Time; United States National Institutes of Health; Vaccines; Work; Writing; ZIKA; clinical decision support; clinical decision-making; clinical epidemiology; data collection methodology; data management; data mining; design; disease natural history; epidemiology study; flexibility; global health; improved; interest; novel; pandemic preparedness; pandemic response; prevent pandemics; public health emergency; relative cost; response; social; statistical and machine learning

Work on this project began with the publication of an opinion piece in Nature Medicine on the need for improving nonrandomized clinical studies from an epidemiologic, ethical, and legal standpoint. Meta-research is currently underway to evaluate early data availability, data collection methodology, critical missing elements, and study limitations published in the first year after significant outbreaks like SARS-CoV-1, H1N1, Ebola, and Zika. Data mining via a scoping review of early literature from these epidemics is in progress with the help of the NIH Library, including a summary of the duration between identification of the outbreak and publication of the first information as well as how this information was disseminated, noting changes over time. In September 2023, the EDMU is hosting a workshop at NIH to develop a consensus on best practices for collecting data using nonrandomized study designs in epidemic settings. This stakeholder engagement workshop will bring together epidemiologists, data managers, clinical standards developers, ethicists, legal experts, social scientists, and data end users to understand the current data collection landscape and develop best practices for improving data collection in the future. The workshop will consist of participatory discussions prompted by original writings/talks by participants, carefully selected background readings, and a series of pre-identified questions. Output will include a formal report as well as a peer-reviewed manuscript with consensus recommendations for improving non-randomized studies in epidemic settings.

该项目的工作始于在自然医学中发表意见文章，即从流行病学，道德和法律角度来改善非随机临床研究的必要性。 目前正在进行元研究，以评估早期数据的可用性，数据收集方法，严重的缺失元素和研究局限性，此前在SARS-COV-1，H1N1，埃博拉病毒，埃博拉病毒和Zika等大量爆发后发表的局限性。通过NIH图书馆的帮助，通过对这些流行病的早期文献进行的范围审查进行数据挖掘，包括摘要概述了爆发爆发与发表第一份信息的持续时间以及如何传播此信息之间的持续时间，并指出随着时间的推移而变化。 2023年9月，EDMU将在NIH举办一项研讨会，以在流行病环境中使用非随机研究设计收集数据的最佳实践达成共识。该利益相关者参与研讨会将汇集流行病学家，数据经理，临床标准开发人员，伦理学家，法律专家，社会科学家和数据最终用户，以了解当前的数据收集景观并开发未来改善数据收集的最佳实践。研讨会将包括参与者的参与性讨论，由参与者的原始著作/演讲，精心挑选的背景读物以及一系列预见的问题。输出将包括正式报告以及经过同行评审的手稿，并提出共识建议，以改善流行病的非随机研究。