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

基本信息

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
项目类别：
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

项目摘要

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年冠状病毒病（COVID-19）目前是一项大流行，目前没有预防或当前治疗，造成了前所未有的破坏和成本。 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 coordination 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感染了病毒负荷的成年人。美国疾病控制与预防中心的初步指导和美国牙科协会建议牙科提供者让患者使用手术前杀菌性冲洗，dospite无经验临床证据。该提出的行政补充剂将在Notde-20-022中专门解决该项目，“对口服微生物群现有的治疗调节剂的试点测试可能会限制SARSCOV-2的感染”。 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具有相关的跨学科专业知识，以及在NIH研究财团中为多个健康和口腔健康项目服务的数据协调中心经验。随着儿童（OHDC）协调中心的NIDCR口腔健康差异，团队表明了其合作，创造性地支持大规模，临床上与临床，预防试验研究的能力，仅在9个UH2研究中，然后在4个UH3的4个UH3随机临床试验中，在3个时期的3个时代跨度ZONES中实现整体科学和Project Separts Commution Community Community Community Community Community andific andific Community Community andific andific Community Calligic and Community Community andivic and opprojectial socige and opproject socige and。 CC将与试点项目团队建立持续的，合作的关系，以在以下领域提供服务和专业知识：（a）与口腔健康相关的临床知识；（b）定量研究设计，特别着重于潜水员人群的健康结果；（c）选择，开发和完善测量工具；（d）信息，包括提供安全的，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）培训这些系统的使用；（f）参与安全监控和向项目调查人员报告；（g）数据管理，处理和质量控制；（h）精炼定量数据分析计划；（i）向项目调查人员报告审判进度；（j）进行统计分析，包括任何随访试验的样本量估计。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有效，全面的支持，该试验可以提供关键知识，以构成经验基础，以制定策略，以使潜在的卫生保健工作者，一线工人，高风险个人，例如免疫受损的人（包括乳腺癌患者）（包括乳腺癌患者）以及受健康偏见影响的群体。