Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose
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引用次数: 4

Abstract

Introduction

Oral cancer is a significant health problem in India. Diagnosis is often delayed. The effectiveness of conventional oral screening has been shown in the Trivandrum oral cancer screening study. The present study will be a step forward to test a mobile phone-based (the mHealth approach) comparing it with the conventional approach. The purpose of this paper is to report the protocol for this study. The primary objective will be to compare both methods in diagnosing oral potentially malignant disorders and cancers. The secondary objective would be to study the cost-effectiveness.

Methods and analysis

This will be a cluster-randomized clinical trial of the population in Ernakulam district of Kerala state in India. They will undergo oral cancer screening by community health workers, who will be pre-assigned to the randomly allotted intervention (mHealth) or control (conventional method) clusters. We will enrol a minimum of 9696 subjects from all 6 clusters over 18 months. The cost-effectiveness of the two strategies for oral screening will be determined using data from this randomized controlled trial. The incremental cost per oral cancer/high-risk dysplasia detected, and the incremental cost per life saved will be reported. We will conduct sensitivity and scenario analysis to evaluate the robustness of the findings.

Ethics and dissemination

When completed, this will be the first cluster randomized population-based study to test the technology-based approach in India. The knowledge from this study will indicate whether specialists can make a remote diagnosis of oral lesions accurately based on the information gathered using a mobile phone health application and whether the mHealth strategy will be cost-effective in Oral cancer screening. The study will follow the ethical guidelines and will be published in an indexed journal.

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使用基于移动电话的(mHealth)方法与传统口腔检查方法进行口腔癌筛查,具有成本-效果分析的聚类随机研究方案
口腔癌在印度是一个严重的健康问题。诊断常常被延误。Trivandrum口腔癌筛查研究显示了传统口腔筛查的有效性。目前的研究将向前迈出一步,测试一种基于移动电话的(移动健康方法),并将其与传统方法进行比较。本文的目的是报告本研究的方案。主要目的是比较两种诊断口腔潜在恶性疾病和癌症的方法。第二个目标是研究成本效益。方法和分析这将是印度喀拉拉邦Ernakulam地区人群的一项集群随机临床试验。他们将接受社区卫生工作者的口腔癌筛查,这些卫生工作者将被预先分配到随机分配的干预(移动健康)或控制(传统方法)组。我们将在18个月内从所有6个组中招募至少9696名受试者。这两种口腔筛查策略的成本效益将根据这项随机对照试验的数据来确定。将报告每个检测到的口腔癌/高危不典型增生的增量成本,以及每个挽救生命的增量成本。我们将进行敏感性和情景分析,以评估研究结果的稳健性。伦理和传播完成后,这将是第一个在印度测试基于技术的方法的基于人群的随机研究。来自本研究的知识将表明专家是否可以根据使用手机健康应用程序收集的信息准确地对口腔病变进行远程诊断,以及移动健康策略在口腔癌筛查中是否具有成本效益。该研究将遵循伦理准则,并将发表在索引期刊上。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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