Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose
{"title":"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","authors":"Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose","doi":"10.1016/j.isjp.2020.07.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 1-5"},"PeriodicalIF":1.1000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.001","citationCount":"4","resultStr":"{\"title\":\"Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis\",\"authors\":\"Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose\",\"doi\":\"10.1016/j.isjp.2020.07.001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div>\",\"PeriodicalId\":42077,\"journal\":{\"name\":\"International Journal of Surgery Protocols\",\"volume\":\"23 \",\"pages\":\"Pages 1-5\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2020-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.001\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Surgery Protocols\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2468357420300218\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Surgery Protocols","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468357420300218","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"SURGERY","Score":null,"Total":0}
Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis
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.
期刊介绍:
IJS Protocols is the first peer-reviewed, international, open access journal seeking to publish research protocols across across the full breadth of the surgical field. We are aim to provide rapid submission to decision times whilst maintaining a high quality peer-review process.