两种远程牙科工具在养老院中的诊断性能：一项前瞻性诊断研究的 ONE-1 方案。
Diagnostic performance of two teledentistry tools in elderly care facilities: the ONE-1 protocol for a pilot prospective diagnostic study.
机构信息
Interpsy Research Unit, UR 4432, Lorraine University, Nancy, France.
CHRU Nancy, Department of Public Health Dentistry, University Hospital, University of Lorraine, Vandœuvre-lès-Nancy, France.
出版信息
BMJ Open. 2023 Apr 3;13(4):e063906. doi: 10.1136/bmjopen-2022-063906.
INTRODUCTION
Elderly people living in care facilities suffer from difficulties in accessing preventive and curative dental care. This leads to poor oral health, which is an increased risk of systemic diseases, in a fragile and dependent population. All this contributes to a progressive loss of autonomy and a decreased quality of life. The use of information and communication technologies through oral telemedicine could help to overcome these barriers. We described the protocol for evaluating the diagnostic performance of two intraoral cameras against a gold standard clinical examination.
METHODS AND ANALYSIS
We conduct a pilot multicentric and prospective diagnostic study (a minimal-risk, minimal-burden interventional research called ONE-1 (for Oral graNd Est step 1)) on two intraoral diagnostic tools (Soprocare camera and consumer camera) compared with a reference intraoral examination. Patients in four elderly care facilities will be included, with randomisation of participant selection and randomisation of the order of the three intraoral examinations performed by a dental surgeon. We will evaluate the diagnostic performance of each device with the asynchronous analysis of videos by two independent dental surgeons against the clinical gold standard examination performed by a single, third dental examiner. The primary outcome is the presence of at least one tooth decay in the dentition of each study participant. Second, we will evaluate the presence of other dental or oral diseases, and the time required to perform each examination. Finally, we will evaluate the organisation of patient follow-up.
ETHICS AND DISSEMINATION
The protocol has been approved by the French ethics committee (Protection to Persons Committee, Nord-Ouest IV on 9 June 2021 and on 28 November 2022). Results will be disseminated through conferences' presentations and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT05089214.
简介
居住在护理机构中的老年人在获得预防性和治疗性牙科保健方面存在困难。这导致口腔健康状况不佳，使脆弱和依赖的人群面临更高的系统性疾病风险。所有这些都导致了自主能力的逐渐丧失和生活质量的下降。通过口腔远程医疗使用信息和通信技术可能有助于克服这些障碍。我们描述了评估两种口腔内相机与金标准临床检查相比的诊断性能的方案。
方法和分析
我们在四家老年人护理机构中开展了一项试点多中心前瞻性诊断研究（一项称为 ONE-1（用于口腔重大步骤 1 的初步评估）的最小风险、最小负担干预性研究），研究了两种口腔内诊断工具（Soprocare 相机和消费者相机）与参考口腔内检查相比的诊断性能。将对参与者进行随机选择和三次口腔内检查的顺序进行随机化，由一名牙科医生进行。我们将通过两名独立的牙科医生对视频进行异步分析，根据单一的、第三名牙科检查者进行的临床金标准检查来评估每种设备的诊断性能。主要结局是每位研究参与者的牙齿中至少有一颗龋齿。其次，我们将评估其他口腔或牙科疾病的存在情况，以及执行每次检查所需的时间。最后，我们将评估患者随访的组织情况。
伦理与传播
该方案已获得法国伦理委员会的批准（北部-西北部 IV 区保护委员会于 2021 年 6 月 9 日和 2022 年 11 月 28 日）。结果将通过会议演讲和同行评议期刊的出版物进行传播。
注册号
NCT05089214。
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