通过分诊和检测实现有效牙科感染控制的务实回归（PREDICT）研究：国家基于牙科实践的研究网络中的一项前瞻性临床研究方案

The Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT) Study: Protocol for a Prospective Clinical Study in the National Dental Practice-Based Research Network.

作者信息

Fredericks-Younger Janine, Fine Daniel H, Subramanian Gayathri, Coker Modupe O, Meyerowitz Cyril, Ragusa Patricia, Allareddy Veerasathpurush, McBurnie Mary Ann, Funkhouser Ellen, Gennaro Maria Laura, Feldman Cecile A

机构信息

School of Dental Medicine, Rutgers University, Newark, NJ, United States.

Eastman Institute for Oral Health, University of Rochester, Rochester, NY, United States.

出版信息

JMIR Res Protoc. 2022 Aug 31;11(8):e38386. doi: 10.2196/38386.

DOI:10.2196/38386

PMID:35944181

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9439378/

Abstract

BACKGROUND

Dental practice has been greatly affected by the COVID-19 pandemic. As SARS-CoV-2 infection is transmitted by respiratory fluids, dental practice techniques, which include aerosol-generating procedures, can increase the risk of transmission causing heightened safety concerns for both dental health care workers (DHCWs) and patients. These concerns have resulted in the reduction in patient volume and the available workforce within dental practices across the United States. Standardized methods for COVID-19 triage and testing may lead to increased safety and perceptions of safety for DHCWs and their patients and promote willingness to provide and access oral health care services.

OBJECTIVE

This study is designed to develop procedures that test the feasibility of enhanced COVID-19 triage and testing in dental offices. It will provide preliminary data to support a larger network-wide study grant application aimed at developing protocols to address safety concerns of patients and DHCWs in a peri-COVID-19 pandemic era.

METHODS

The feasibility study is being conducted in 4 private dental practices, each of which has a dentist member of the National Dental Practice-Based Research Network. Participants include the DHCWs and patients of the dental practice. Study procedures include completion of COVID-19 triage, completion of COVID-19 testing (point-of-care [POC] or laboratory-based [LAB] SARS-CoV-2 viral, antigen, and antibody tests based on office designation), and administration of perception and attitude surveys for participating DCHWs and patients of the dental practice over a defined study period. The office designation and the participant's role in the practice determines which testing protocol is executed within the office. There are 4 study groups following 4 distinct protocols: (1) POC DHCWs, (2) POC patients, (3) LAB DHCWs, and (4) LAB patients.

RESULTS

Data collection began in December of 2021 and concluded in March 2022. Study results are expected to be published in fall 2022.

CONCLUSIONS

The results of this feasibility study will help identify the viability and functionality of COVID-19 triage and testing in dental practices and inform a larger network-wide study grant application that develops protocols that address safety concerns of patients and DHCWs in a COVID-19 environment.

TRIAL REGISTRATION

ClinicalTrials.gov NTC05123742; https://clinicaltrials.gov/ct2/show/NCT05123742?term=NCT05123742.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38386.

摘要

背景

牙科诊疗业务受到新冠疫情的极大影响。由于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）通过呼吸道飞沫传播，包括产生气溶胶的操作在内的牙科诊疗技术会增加传播风险，这引发了牙科医护人员（DHCWs）和患者对安全的高度担忧。这些担忧导致美国各地牙科诊所的患者量和可用劳动力减少。新冠病毒分诊和检测的标准化方法可能会提高DHCWs及其患者的安全性和对安全的认知，并促进提供和接受口腔保健服务的意愿。

目的

本研究旨在制定程序，测试在牙科诊所加强新冠病毒分诊和检测的可行性。它将提供初步数据，以支持一项更大规模的全网络研究资助申请，该申请旨在制定方案，以解决新冠疫情期间患者和DHCWs的安全问题。

方法

可行性研究在4家私人牙科诊所进行，每家诊所都有一名国家基于牙科实践的研究网络的牙医成员。参与者包括牙科诊所的DHCWs和患者。研究程序包括完成新冠病毒分诊、完成新冠病毒检测（根据诊所指定进行即时检测[POC]或基于实验室的检测[LAB]，即SARS-CoV-2病毒、抗原和抗体检测），以及在规定的研究期间对参与研究的牙科诊所DCHWs和患者进行认知和态度调查。诊所的指定以及参与者在诊所中的角色决定了在诊所内执行哪种检测方案。有4个研究组遵循4种不同的方案：（1）POC DHCWs，（2）POC患者，（3）LAB DHCWs，和（4）LAB患者。