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


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.


BACKGROUND
The National Institute for Health Research.
The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK. Electronic address: j@andreyev.demon.co.uk.
H Jervoise N
HJ
Andreyev
The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
Barbara E
BE
Benton
The Gastrointestinal Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
Amyn
A
Lalji
King's College London and Imperial College Healthcare NHS Trust, London, UK.
Christine
C
Norton
Statistics Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
Kabir
K
Mohammed
Deptartment of Economics, University of Surrey, Guildford, UK.
Heather
H
Gage
Statistics Unit, The Royal Marsden NHS Foundation Trust, London and Surrey, UK.
Kjell
K
Pennert
Digestive Diseases Clinical Academic Unit, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, UK.
James O
JO
Lindsay
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D005260:Female; D005762:Gastroenterology; D041981:Gastrointestinal Tract / Q000528:radiation effects*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000209:etiology / Q000451:nursing*; D008297:Male; D008875:Middle Aged; D010174:Pamphlets; D010386:Pelvic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000209:etiology / Q000451:nursing*; D011878:Radiotherapy / Q000009:adverse effects; D016896:Treatment Outcome