Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial

作者：Andreyev H Jervoise N^*; Benton Barbara E; Lalji Amyn; Norton Christine; Mohammed Kabir; Gage Heather; Pennert Kjell; Lindsay James O

来源：Lancet, 2013, 382(9910): 2084-2092.

DOI：10.1016/S0140-6736(13)61648-7

Background Chronic gastrointestinal symptoms after pelvic radiotherapy are common, multifactorial in cause, and affect patients%26apos; 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. %26lt;br%26gt;Methods For this three-arm randomised controlled trial we recruited patients (aged %26gt;= 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 %26lt;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. %26lt;br%26gt;Findings 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). %26lt;br%26gt;Interpretation 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.

• 出版日期2013-12-21