The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23.
Chronic gastrointestinal symptoms after pelvic radiotherapy are common, multifactorial in cause, and affect patients' quality of life. We assessed whether such patients could be helped if a practitioner followed an investigative and management algorithm, and whether outcomes differed by whether a nurse or a gastroenterologist led this algorithm-based care.
For this three-arm randomised controlled trial we recruited patients (aged ≥18 years) from clinics in London, UK, with new-onset gastrointestinal symptoms persisting 6 months after pelvic radiotherapy. Using a computer-generated randomisation sequence, we randomly allocated patients to one of three groups (1:1:1; stratified by tumour site [urological, gynaecological, or gastrointestinal], and degree of bowel dysfunction [IBDQ-B score <60 vs 60-70]): usual care (a detailed self-help booklet), gastroenterologist-led algorithm-based treatment, or nurse-led algorithm-based treatment. The primary endpoint was change in Inflammatory Bowel Disease Questionnaire-Bowel subset score (IBDQ-B) at 6 months, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00737230.
Between Nov 26, 2007, and Dec 12, 2011, we enrolled and randomly allocated 218 patients to treatment: 80 to the nurse group, 70 to the gastroenterologist group, and 68 to the booklet group (figure). Most had a baseline IBDQ-B score indicating moderate-to-severe symptoms. We recorded the following pair-wise mean difference in change in IBDQ-B score between groups: nurse versus booklet 4·12 (95% CI 0·04-8·19; p=0·04), gastroenterologist versus booklet 5·47 (1·14-9·81; p=0·01). Outcomes in the nurse group were not inferior to outcomes in the gastroenterologist group (mean difference 1·36, one sided 95% CI -1·48).
Patients given targeted intervention following a detailed clinical algorithm had better improvements in radiotherapy-induced gastrointestinal symptoms than did patients given usual care. Our findings suggest that, for most patients, this algorithm-based care can be given by a trained nurse.
The National Institute for Health Research.
盆腔放疗后出现慢性胃肠道症状较为常见，病因多因素，影响患者的生活质量。我们评估了从业者是否遵循一种探索性和管理算法是否能帮助此类患者，以及是否由护士或胃肠病医生领导这种基于算法的护理会产生不同的结果。
本项三臂随机对照试验招募了来自英国伦敦诊所的新发胃肠道症状持续 6 个月以上的盆腔放疗后患者（年龄≥18 岁）。使用计算机生成的随机序列，我们将患者随机分配至三组中的一组（1:1:1；按肿瘤部位[泌尿科、妇科或胃肠道]和肠道功能障碍程度[IBDQ-B 评分<60 与 60-70]分层）：常规护理（详细的自我帮助手册）、胃肠病医生主导的基于算法的治疗或护士主导的基于算法的治疗。主要终点是 6 个月时炎症性肠病问卷-肠道亚量表评分（IBDQ-B）的变化，按意向治疗进行分析。本试验在 ClinicalTrials.gov 注册，编号 NCT00737230。
2007 年 11 月 26 日至 2011 年 12 月 12 日，我们招募并随机分配了 218 名患者进行治疗：80 名患者分入护士组，70 名患者分入胃肠病医生组，68 名患者分入手册组（图）。大多数患者基线 IBDQ-B 评分表明症状为中度至重度。我们记录了以下组间 IBDQ-B 评分变化的两两平均差异：护士组与手册组 4.12（95%CI 0.04-8.19;p=0.04），胃肠病医生组与手册组 5.47（1.14-9.81;p=0.01）。护士组的结局并不劣于胃肠病医生组（平均差异 1.36，单侧 95%CI-1.48）。
接受详细临床算法指导的靶向干预的患者与接受常规护理的患者相比，放疗引起的胃肠道症状改善更好。我们的发现表明，对于大多数患者来说，这种基于算法的护理可以由经过培训的护士提供。
英国国家卫生研究院。
