COORDINATING CENTER TO HELP ELIMINATE/REDUCE ORAL HEALTH INEQUALITIES IN CHILDREN

帮助消除/减少儿童口腔健康不平等的协调中心

• 批准号: 10177199
• 负责人: STUART A GANSKY
• 金额: $ 24.23万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10177199
• 关键词: 2019-nCoV; Address; Adherence; Administrative Supplement; Adult; Adult Respiratory Distress Syndrome; Affect; American Dental Association; Area; Biometry; Breast Cancer Patient; COVID-19; COVID-19 pandemic; Calendar; California; California Breast Cancer Research Program; Centers for Disease Control and Prevention (U.S.); Cessation of life; Cetylpyridinium Chloride; Child; Chlorhexidine; Clinical; Clinical Research; Clinical Trials; Communities; Coughing; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Management Resources; Dental; Dental Scaling; Dental caries; Development; Ensure; Epidemiology; Equipment; Foundations; Funding; Gluconates; Goals; Guidelines; Health; Health Benefit; Health Personnel; Hydrogen Peroxide; Hygiene; Immunocompromised Host; In Vitro; Individual; Infection; Infection Control; Influenza; Influenza A Virus, H5N1 Subtype; Informatics; Institution; Knowledge; Lead; Local Anti-Infective Agents; Lower respiratory tract structure; Manuals; Measurement; Measures; Middle East Respiratory Syndrome; Monitor; Mouthwash; National Heart, Lung, and Blood Institute; National Institute of Dental and Craniofacial Research; Oral health; Outcome; Participant; Patients; Pilot Projects; Pneumonia; Population Heterogeneity; Povidone-Iodine; Prevention trial; Preventive treatment; Procedures; Progress Reports; Protocols documentation; Provider; Public Health; Publications; Quality Control; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Design; Research Personnel; Research Project Grants; SARS coronavirus; Safety; Sample Size; Secure; Sepsis; Services; Severe Acute Respiratory Syndrome; Societies; Sore Throat; Statistical Data Interpretation; Surface; Symptoms; System; Testing; Therapeutic; Time; Training; Translational Research; Ultrasonics; United States National Institutes of Health; Universities; Viral Load result; Virus; Water; World Health Organization; chlorine dioxide; clinically relevant; cost; cost effectiveness; curative treatments; data acquisition; data integrity; data management; data quality; disease transmission; early childhood; experience; experimental study; flexibility; follow-up; health disparity; health goals; health inequalities; healthy volunteer; high risk; in vivo; instrument; instrumentation; member; oral microbial community; pandemic disease; participant safety; pilot trial; quality assurance; recruit; research study; respiratory; screening; skills; statistics; tool; waterline biofilm; web site

Coronavirus Disease 2019 (COVID-19) is a pandemic currently without preventive or curative treatments, causing unprecedented disruption and costs to individuals and society. This COVID-19 Administrative Supplement to the “Coordinating Center to Help Eliminate/Reduce Oral Health Inequalities in Children” (CC) (U01DE025507) will leverage collaborative research and coordinating center expertise and services to a University of California Office of the President (UCOP) reviewed and California Breast Cancer Research Program funded (R00RG2901) pilot trial to assess antiseptic mouthwashes in SARS-CoV-2 infected adults on viral load. Initial guidance from US Centers for Disease Control and Prevention and American Dental Association recommended dental providers have patients use a pre-procedural antiseptic rinse, despite no empirical clinical evidence. This proposed administrative supplement will specifically address the item in NOTDE-20-022 “Pilot testing of existing therapeutic modulators of oral microbiota that may limit infectivity of SARSCoV-2”. The CC team possesses relevant transdisciplinary expertise in clinical trials, epidemiology, biostatistics, clinical research, and oral health, as well as data coordinating center experience serving multiple health and oral health projects in NIH research consortia. As the NIDCR Oral Health Disparities in Children (OHDC) Consortium’s Coordinating Center the team has demonstrated its ability to collaboratively and creatively support large-scale, clinically-relevant, prevention trial research simultaneously in 9 UH2 studies and then in 4 UH3 randomized clinical trials in 6 institutions across 3 time zones to meet the overall scientific and project community partner goals. The CC will establish ongoing, collaborative relationships with the pilot project team to provide services and expertise in the following areas: (a) oral health-related clinical knowledge; (b) quantitative research design with particular emphasis on health outcomes in diverse populations; (c) selecting, developing, and refining measurement instruments; (d) informatics, including providing secure, customized data acquisition systems and project management and clinical trials management systems; (e) training in the use of those systems; (f) participant safety monitoring and reporting to the project investigators; (g) data management, processing, and quality control; (h) refining quantitative data analysis plans; (i) reporting on trial progress to the project investigators; and (j) perform statistical analyses including sample size estimation for any follow-up trials. Our experienced Coordinating Center team can provide efficient, comprehensive support to this UCOP funded pilot trial which could provide critical knowledge to form the empirical foundation to develop strategies to potentially benefit health care workers, frontline workers, high risk individuals such as immunocompromised people (including breast cancer patients), and groups impacted by health disparities.

2019冠状病毒病（COVID-19）是一种目前没有预防或治疗方法的大流行，给个人和社会造成了前所未有的破坏和代价。本“帮助消除/减少儿童口腔健康不平等协调中心”（CC） （U01DE025507）的COVID-19行政补充文件将利用合作研究和协调中心的专业知识和服务，为加州大学校长办公室（UCOP）审查和加州乳腺癌研究计划资助的试点试验（R00RG2901）评估消毒漱口水对SARS-CoV-2感染成人的病毒含量进行评估。美国疾病控制和预防中心和美国牙科协会的初步指导建议牙科提供者让患者使用手术前消毒冲洗，尽管没有经验临床证据。这项拟议的行政补充将专门处理NOTDE-20-022“可能限制SARSCoV-2传染性的口服微生物群现有治疗性调节剂的试点测试”中的项目。CC团队在临床试验、流行病学、生物统计学、临床研究和口腔健康方面拥有相关的跨学科专业知识，并在NIH研究联盟的多个健康和口腔健康项目中拥有数据协调中心的经验。作为NIDCR儿童口腔健康差异（OHDC）联盟的协调中心，该团队已经证明了其协作和创造性地支持同时进行9项UH2研究和4项UH3随机临床试验的大规模，临床相关的预防试验研究的能力，这些试验在3个时区的6个机构进行，以满足整体科学和项目社区合作伙伴的目标。中心将与试点项目团队建立持续的合作关系，在以下领域提供服务和专业知识：(a)口腔健康相关的临床知识；(b)定量研究设计，特别强调不同人群的健康结果；(c)选择、开发和改进测量仪器；(d)信息学，包括提供安全、定制的数据采集系统以及项目管理和临床试验管理系统；(e)使用这些系统的培训；(f)参与安全监测并向项目调查人员报告；(g)数据管理、处理和质量控制；(h)完善定量数据分析方案；(i)向项目调查人员报告试验进展；(j)对任何后续试验进行统计分析，包括样本量估计。我们经验丰富的协调中心团队可以为这项UCOP资助的试点试验提供高效、全面的支持，该试验可以提供关键知识，形成经验基础，以制定可能惠及卫生保健工作者、一线工作人员、免疫功能低下人群（包括乳腺癌患者）等高危人群的策略，以及受健康差异影响的群体。