Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia
Paediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia.
BMJ Open. 2020 May 27;10(5):e037609. doi: 10.1136/bmjopen-2020-037609.
Rheumatic heart disease (RHD) causes significant morbidity and mortality in young people from disadvantaged populations. Early detection through echocardiography screening can facilitate early access to treatment. Large-scale implementation of screening could be feasible with the combination of inexpensive standalone ultrasound transducers and upskilling non-expert practitioners to perform abbreviated echocardiography.
A prospective cross-sectional study will evaluate an abbreviated echocardiography screening protocol for the detection of latent (asymptomatic) RHD in high-risk populations. The study will evaluate the diagnostic accuracy of health worker conducted single parasternal long axis view with a sweep using handheld devices (SPLASH) (Philips Lumify S4-1 phased array transducer). Each participant will have at least one reference test performed on the same day by an expert echocardiographer. Diagnosis of RHD will be determined by a panel of three experts, using 2012 World Heart Federation criteria. Sensitivity and specificity of the index test will be calculated with 95% CIs, to determine diagnostic accuracy of a screen-and-refer approach to echocardiography screening for RHD. Remote review of SPLASH images obtained by health workers will facilitate evaluation of the sensitivity and specificity of an alternative approach, using external review of health worker obtained SPLASH images to decide onward referral.
Ethics approval was obtained from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research, for the project to be carried out in Timor-Leste (HREC 2019-3399), and in Australia, following review by the Aboriginal Ethics subcommittee (HREC 2019-334). Ethical and technical approval was granted in Timor-Leste, by the Institute National of Health Research Ethics and Technical Committee (1073-MS-INS/GDE/VII/2019). Study results will be disseminated in the communities involved in the study, and through peer-reviewed publications and conference abstracts.
The Australia New Zealand Clinical Trials Registry (ACTRN12620000122954).
风湿性心脏病（RHD）会给来自弱势群体的年轻人带来严重的发病率和死亡率。通过超声心动图筛查早期发现可以促进早期治疗。通过将廉价的独立超声换能器与对非专家从业者进行简化超声心动图操作的技能提升相结合，可以实现大规模筛查。
一项前瞻性横断面研究将评估一种简化的超声心动图筛查方案，用于检测高危人群中潜伏（无症状）RHD。该研究将评估使用手持式设备进行的单个胸骨旁长轴扫查（SPLASH）（飞利浦 Lumify S4-1 相控阵换能器）进行的卫生工作者进行的简化超声心动图筛查方案的诊断准确性。每个参与者都将在同一天由专家超声心动图医师进行至少一次参考测试。RHD 的诊断将由一个由三名专家组成的小组根据 2012 年世界心脏联合会标准确定。将使用 95%置信区间计算指标测试的敏感性和特异性，以确定 RHD 超声心动图筛查的筛检-转诊方法的诊断准确性。卫生工作者获得的 SPLASH 图像的远程审查将有助于评估替代方法的敏感性和特异性，方法是使用卫生工作者获得的 SPLASH 图像的外部审查来决定进一步转诊。
该项目在东帝汶（HREC 2019-3399）和澳大利亚获得了北领地卫生部和 Menzies 健康研究学院人类研究伦理委员会的伦理批准，在澳大利亚，在澳大利亚土著伦理小组委员会（HREC 2019-334）审查后获得了批准。东帝汶国家健康研究伦理和技术委员会（1073-MS-INS/GDE/VII/2019）授予了在东帝汶的伦理和技术批准。研究结果将在参与研究的社区中传播，并通过同行评议的出版物和会议摘要传播。
澳大利亚新西兰临床试验注册中心（ACTRN12620000122954）。
