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尼泊尔学童风湿性心脏病患病率及心血管结局的基于人群研究方案。

Protocol for a population-based study of rheumatic heart disease prevalence and cardiovascular outcomes among schoolchildren in Nepal.

作者信息

Pilgrim Thomas, Kalesan Bindu, Karki Prahlad, Basnet Anil, Meier Bernhard, Urban Philip, Shrestha Nikesh Raj

机构信息

Department of Cardiology, Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.

出版信息

BMJ Open. 2012 Jun 8;2(3). doi: 10.1136/bmjopen-2012-001320. Print 2012.

Abstract

INTRODUCTION

Rheumatic heart disease (RHD) remains a major contributor to morbidity and mortality in developing countries. The reported prevalence rates of RHD are highly variable and mainly attributable to differences in the sensitivity of either clinical screening to detect advanced heart disease or echocardiographic evaluation where disease is diagnosed earlier across a continuous spectrum. The clinical significance of diagnosis of subclinical RHD by echocardiographic screening and early implementation of secondary prevention has not been clearly established.

METHODS AND ANALYSIS

The authors designed a cross-sectional survey to determine the prevalence of RHD in children from private and public schools between the age of 5 and 15 years in urban and rural areas of Eastern Nepal using both cardiac auscultation and echocardiographic evaluation. Children with RHD will be treated with secondary prevention and enrolled in a prospective cohort study. The authors will compare the prevalence rates by cardiac auscultation and echocardiography, determine risk factors associated with diagnosis and progression of RHD, investigate social and economic barriers for receiving adequate cardiac care and assess clinical outcomes with regular medical surveillance as a function of stage of disease at the time of diagnosis. Prospective clinical studies investigating the impact of secondary prevention for subclinical RHD on long-term clinical outcome will be of central relevance for future health resource utilisation in developing countries.

ETHICS AND DISSEMINATION

The study was considered ethically uncritical and was given an exempt status by the ethics committee at University of Bern, Switzerland. The study has been submitted to the National Nepal Health Research Council and was registered with http://www.ClinicalTrials.gov (NCT01550068). The study findings will be reported in peer-reviewed publications. CLINICALTRIALS.GOV IDENTIFIER: NCT01550068.

摘要

引言

在发展中国家,风湿性心脏病(RHD)仍是发病和死亡的主要原因。报告的RHD患病率差异很大,主要归因于临床筛查检测晚期心脏病的敏感性差异,或超声心动图评估差异,在超声心动图评估中,疾病可在连续范围内更早被诊断。通过超声心动图筛查诊断亚临床RHD以及早期实施二级预防的临床意义尚未明确确立。

方法与分析

作者设计了一项横断面调查,以确定尼泊尔东部城乡地区5至15岁私立和公立学校儿童中RHD的患病率,采用心脏听诊和超声心动图评估两种方法。患有RHD的儿童将接受二级预防治疗,并纳入一项前瞻性队列研究。作者将比较心脏听诊和超声心动图的患病率,确定与RHD诊断和进展相关的危险因素,调查获得充分心脏护理的社会和经济障碍,并根据诊断时疾病阶段通过定期医学监测评估临床结果。调查亚临床RHD二级预防对长期临床结果影响的前瞻性临床研究对于发展中国家未来的卫生资源利用至关重要。

伦理与传播

该研究被认为在伦理上无重大问题,瑞士伯尔尼大学伦理委员会给予其豁免地位。该研究已提交给尼泊尔国家卫生研究委员会,并在http://www.ClinicalTrials.gov(NCT01550068)注册。研究结果将在同行评审的出版物中报告。临床试验注册编号:NCT01550068。

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