Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Health Technol Assess. 2010 Mar;14(13):1-164, iii-iv. doi: 10.3310/hta14130.
To examine the clinical effectiveness and cost-effectiveness of tonsillectomy/adeno-tonsillectomy in children aged 4-15 years with recurrent sore throats in comparison with standard non-surgical management.
A pragmatic randomised controlled trial with economic analysis comparing surgical intervention with conventional medical treatment in children with recurrent sore throats (trial) and a parallel non-randomised cohort study (cohort study).
Five secondary care otolaryngology departments located in the north of England or west of Scotland.
268 (trial: 131 allocated to surgical management; 137 allocated to medical management) and 461 (cohort study: 387 elected to have surgical management; 74 elected to have medical management) children aged between 4 and 15 years on their last birthday with recurrent sore throats. Participants were stratified by age (4-7 years, 8-11 years, 12-15 years).
Treatment was tonsillectomy and adeno-tonsillectomy with adenoid curettage and tonsillectomy by dissection or bipolar diathermy according to surgical preference within 12 weeks of randomisation. The control was non-surgical conventional medical treatment only.
The primary clinical outcome was the reported number of episodes of sore throat in the 2 years after entry into the study. Secondary clinical outcomes included: the reported number of episodes of sore throat; number of sore throat-related GP consultations; reported number of symptom-free days; reported severity of sore throats; and surgical and anaesthetic morbidity. In addition to the measurement of these clinical outcomes, the impact of the treatment on costs and quality of life was assessed.
Of the 1546 children assessed for eligibility, 817 were excluded (531 not meeting inclusion criteria, 286 refused) and 729 enrolled to the trial (268) or cohort study (461). The mean (standard deviation) episode of sore throats per month was in year 1 - cohort medical 0.59 (0.44), cohort surgical 0.71 (0.50), trial medical 0.64 (0.49), trial surgical 0.50 (0.43); and in year 2 - cohort medical 0.38 (0.34), cohort surgical 0.19 (0.36), trial medical 0.33 (0.43), trial surgical 0.13 (0.21). During both years of follow-up, children randomised to surgical management were less likely to record episodes of sore throat than those randomised to medical management; the incidence rate ratios in years 1 and 2 were 0.70 [95% confidence interval (CI) 0.61 to 0.80] and 0.54 (95% CI 0.42 to 0.70) respectively. The incremental cost-effectiveness ratio was estimated as 261 pounds per sore throat avoided (95% confidence interval 161 pounds to 586 pounds). Parents were willing to pay for the successful treatment of their child's recurrent sore throat (mean 8059 pounds). The estimated incremental cost per quality-adjusted life-year (QALY) ranged from 3129 pounds to 6904 pounds per QALY gained.
Children and parents exhibited strong preferences for the surgical management of recurrent sore throats. The health of all children with recurrent sore throat improves over time, but trial participants randomised to surgical management tended to experience better outcomes than those randomised to medical management. The limitations of the study due to poor response at follow-up support the continuing careful use of 'watchful waiting' and medical management in both primary and secondary care in line with current clinical guidelines until clear-cut evidence of clinical effectiveness and cost-effectiveness is available.
Current Controlled Trials ISRCTN47891548.
比较扁桃体切除术/腺样体切除术与标准非手术治疗在 4-15 岁复发性咽痛儿童中的临床疗效和成本效益。
一项比较手术干预与儿童复发性咽痛常规药物治疗的实用随机对照试验（试验）和一项平行非随机队列研究（队列研究），具有经济分析。
英格兰北部或苏格兰西部的 5 个二级护理耳鼻喉科部门。
268 名（试验：131 名分配给手术管理；137 名分配给医疗管理）和 461 名（队列研究：387 名选择手术管理；74 名选择医疗管理）在他们最后一个生日时年龄在 4 至 15 岁之间的儿童，患有复发性咽痛。参与者按年龄（4-7 岁、8-11 岁、12-15 岁）分层。
治疗是扁桃体切除术和腺样体切除术，伴腺样体切除术和扁桃体切除术，根据手术偏好，在随机分组后 12 周内进行。对照组仅为非手术常规药物治疗。
主要临床结局是入组后 2 年内报告的咽痛发作次数。次要临床结局包括：报告的咽痛发作次数；咽痛相关的 GP 咨询次数；报告的无症状天数；报告的咽痛严重程度；以及手术和麻醉发病率。除了测量这些临床结局外，还评估了治疗对成本和生活质量的影响。
在评估的 1546 名合格儿童中，817 名被排除（531 名不符合纳入标准，286 名拒绝），729 名入组试验（268 名）或队列研究（461 名）。第 1 年的平均（标准差）每月咽痛发作次数-队列医疗 0.59（0.44），队列手术 0.71（0.50），试验医疗 0.64（0.49），试验手术 0.50（0.43）；第 2 年-队列医疗 0.38（0.34），队列手术 0.19（0.36），试验医疗 0.33（0.43），试验手术 0.13（0.21）。在两年的随访期间，与接受药物治疗的儿童相比，接受手术治疗的儿童更有可能记录咽痛发作；第 1 年和第 2 年的发病率比值分别为 0.70 [95%置信区间（CI）0.61-0.80]和 0.54（95% CI 0.42-0.70）。增量成本效益比估计为避免每例咽痛发生 261 英镑（95%置信区间 161 英镑至 586 英镑）。父母愿意为治疗其子女的复发性咽痛支付费用（平均 8059 英镑）。估计每例获得的质量调整生命年（QALY）的增量成本范围为 3129 英镑至 6904 英镑/QALY。
儿童和家长对复发性咽痛的手术治疗表现出强烈的偏好。所有患有复发性咽痛的儿童的健康状况随着时间的推移会逐渐改善，但与接受药物治疗的随机分组参与者相比，接受手术治疗的参与者往往会有更好的结局。由于随访时反应不佳而导致研究存在局限性，支持在初级和二级保健中继续谨慎使用“静观其变”和药物治疗，同时根据当前临床指南，直到有明确的临床疗效和成本效益证据为止。
当前对照试验 ISRCTN47891548。
