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首页> 外文期刊>BMC Ear, Nose and Throat Disorders >Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats
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Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

机译：英格兰北部和苏格兰北部儿童扁桃体切除术和腺扁桃体切除术研究协议（NESSTAC）。实用性随机对照试验比较了复发性喉咙痛儿童的外科手术干预与常规药物治疗

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Background Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. Methods/design A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008). Discussion As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.
机译：背景技术关于儿童扁桃体切除术治疗复发性喉咙痛的有效性和成本效益的不确定性，促使NHS健康技术评估计划委托这项研究，以评估扁桃体切除术和腺扁桃体切除术与标准非手术治疗相比的有效性和成本效益。 16岁以下儿童反复出现喉咙感染。目的是评估扁桃体切除术和腺扁桃体切除术是否在临床上显着减少了儿童喉咙痛的发作次数。方法/设计一项简单的前瞻性，实用，随机对照试验，包括经济分析和非试验参与者的前瞻性队列研究，比较了手术干预和常规药物治疗。治疗组将接受扁桃体切除术和腺扁桃体切除术，而在对照组中，将仅使用非手术常规医学治疗。主要结局指标为报告的两年内咽痛发作次数，次要结局指标为报告的喉咙痛发作，中耳炎和上呼吸道感染发作次数，需要进行全科医生咨询;报告的无症状天数;报告了喉咙痛的严重程度以及手术和麻醉的发病率。该研究将在英国的五家医院进行。该试验人群将是406名4岁至15岁的儿童，他们的最后一个生日年龄在4岁至15岁之间，喉咙痛由初级保健转介给5个耳鼻咽喉科。研究时间为七年（2001年7月至2008年7月）。讨论与所有实用的随机对照试验一样，不可能控制进行研究的外部环境。自该试验开始以来，已经出现了许多可能影响结果的因素，包括：减少了呼吸道感染的发生率，咨询率的社会经济差异显着，国家前瞻性扁桃体切除术审计和政府的候补名单倡议的结果。

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