• H Jervoise N Andreyev, Barbara E Benton, Amyn Lalji, Christine Norton, Kabir Mohammed, Heather Gage, Kjell Pennert, and James O Lindsay.
• The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK. Electronic address: j@andreyev.demon.co.uk.
• Lancet. 2013 Dec 21; 382 (9910): 208420922084-92.

BackgroundChronic 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.MethodsFor 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.FindingsBetween 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).InterpretationPatients 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.FundingThe National Institute for Health Research.Copyright © 2013 Elsevier Ltd. All rights reserved.

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