Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Otolaryngol Head Neck Surg. 2012 Jan;146(1):122-8. doi: 10.1177/0194599811422011. Epub 2011 Sep 22.
To compare the estimated cost-effectiveness of childhood (adeno)tonsillectomy vs medical therapy for recurrent sore throats from the intention-to-treat (ITT) analysis of a randomized controlled trial (RCT) with that modeled on the recorded timing of surgical interventions as observed in all participants irrespective of their original group allocation.
A pragmatic RCT (trial) with a parallel nonrandomized patient preference group (cohort) of (adeno)tonsillectomy vs medical therapy.
Five secondary care UK otolaryngology departments.
Eligible children, aged 4 to 15 years, were enrolled to the trial (268) or cohort (461) groups. Outcomes included sore throat diaries, quality of life, and general practice consultations. The RCT protocol ITT analysis was compared with an as-treated analysis incorporating the cohort group, modeled to reflect the timing of tonsillectomy and the differential switch rates among the original groups.
In the RCT ITT analysis, tonsillectomy saved 3.5 sore throats, whereas the as-treated model suggested an average reduction of more than 8 sore throats in 2 years for surgery within 10 weeks of consultation, falling to only 3.5 twelve months later due to the spontaneous improvement in the medical therapy group.
In eligible UK school-age children, tonsillectomy can save up to 8 sore throats at a reasonable cost, if performed promptly. Further prospective data collection, accounting for baseline and per-trial preferences and choice, is urgently needed.
从随机对照试验(RCT)的意向治疗(ITT)分析比较儿童(腺样体)扁桃体切除术与复发性咽痛药物治疗的成本效益,该 RCT 中记录了手术干预的时间,而不论参与者的原始分组如何,均观察到所有参与者的实际手术时间。
一项实用的 RCT(试验),并结合了(腺样体)扁桃体切除术与药物治疗的非随机患者偏好组(队列)。
英国五家二级保健耳鼻喉科部门。
年龄在 4 至 15 岁之间的合格儿童被纳入试验(268 例)或队列(461 例)组。结果包括咽痛日记、生活质量和全科医生咨询。将 RCT 的 ITT 协议分析与包含队列组的治疗分析进行了比较,该模型反映了扁桃体切除术的时间以及原始组之间的差异转换率。
在 RCT 的 ITT 分析中,扁桃体切除术可减少 3.5 次咽痛,而治疗模型表明,在咨询后 10 周内进行手术,在 2 年内手术组平均可减少 8 次以上咽痛,但 12 个月后,由于药物治疗组的自发性改善,仅减少 3.5 次咽痛。
在符合条件的英国学龄儿童中,如果及时进行手术,扁桃体切除术可以节省多达 8 次咽痛,并且迫切需要进一步前瞻性收集数据,考虑到基线和每例试验的偏好和选择。