In the ORBIT trial, reported in The Lancet, Andreyev et al compared outcomes with usual care, gastroenterologist-led algorithm-based management, and nurse-led algorithm-based management for patients with chronic gastrointestinal symptoms following pelvic radiotherapy for cancer. The findings indicated that outcomes are improved with algorithm-based care and that there is no significant difference between outcomes with nurse-led care or gastroenterologist-led care.
In the study, 218 patients from London clinics who had new-onset gastrointestinal symptoms persisting 6 months after pelvic radiotherapy were randomly assigned to usual care (n = 68), gastroenterologist-led algorithm-based care (n = 70), or nurse-led algorithm-based care (n = 80). Patients were stratified by tumor site. Usual care included patient use of a detailed self-help booklet. The algorithm used by gastroenterologists and nurses has been developed by the investigators to provide a stepped approach along a pathway from initial identification of symptoms to long-term management. Patients had to be well enough to be managed as outpatients.
The primary endpoint was change in Inflammatory Bowel Disease Questionnaire–Bowel subset score (IBDQ-B) at 6 months. A change in score of 6 or more in the IBDQ-B is considered clinically relevant from the patient perspective. A difference in change between the two algorithm groups of ≤ 4 was predefined as the threshold for noninferiority of the nurse-led approach vs gastroenterologist-led management.
The booklet, gastroenterologist, and nurse groups were generally balanced for age (median, 69.5, 68.5, and 67 years), sex (75%, 79%, and 77% male), total radiotherapy dose (median, 64.5, 70, and 60 Gy), primary tumor site (gastrointestinal in 15%, 7%, and 16%; gynecologic in 16%, 17%, and 14%; and urologic in 69%, 76%, and 70%), previous colorectal surgery (3%, 4%, and 8%), and domestic circumstances (eg, living alone for 16%, 21%, and 25%).
At baseline, 63% of the booklet group, 69% of the gastroenterologist group, and 67% of the nurse group had moderate or severe gastrointestinal symptoms as indicated by IBDQ-B score < 60 and 37%, 31%, and 33% had mild symptoms as indicated by a score ≥ 60.
Mean improvement in the IBDQ-B score at 6 months in the booklet group was 4.9 points (standard deviation, 13.2), a change not considered to be clinically significant; 44% of patients requested gastroenterologist review after 6 months. Clinically significant improvements in IBDQ-B scores of 10.4 (standard deviation, 10.3) in the gastroenterologist group and 9.1 (standard deviation, 8.84) in the nurse group were observed at 6 months.
Mean differences between the gastroenterologist group (5.47, P = .01) and nurse group (4.12, P = .04) vs the usual care group were statistically significant. The mean difference in score between the gastroenterologist and nurse groups at 6 months was 1.36, lower than the predefined difference of > 4.0 indicating inferiority of outcome in the nurse group. The one-sided 95% confidence interval of –1.48 strongly suggested that outcome was not poorer in the nurse group.
The investigators concluded, “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.”
H. Jervoise N. Andreyev, FRCP, of The Royal Marsden NHS Foundation Trust, is the corresponding author for The Lancet article.
The study was funded by the National Institute for Health Research. The study authors reported no potential conflicts of interest.
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