Department of Medical Gastroenterology, Oslo University Hospital, Ullevål, Oslo, Norway.
Surg Endosc. 2011 Oct;25(10):3162-9. doi: 10.1007/s00464-011-1680-7. Epub 2011 Apr 13.
The clinical effect of stent treatment has been evaluated by mainly physicians; only a limited number of prospective studies have used patient-reported outcomes for this purpose. The aim of this work was to study the clinical effect of self-expanding metal stents in treatment of malignant gastrointestinal obstructions, as evaluated by patient-reported outcomes, and compare the rating of the treatment effect by patients and physicians.
Between November 2006 and April 2008, 273 patients treated with SEMS for malignant GI and biliary obstructions were recruited from nine Norwegian hospitals. Patients and physicians assessed symptoms independently at the time of treatment and after 2 weeks using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire supplemented with specific questions related to obstruction.
A total of 162 patients (99 males; median age = 72 years) completed both assessments and were included in the study. A significant improvement in the mean global health score was observed after 2 weeks (from 9 to 18 on a 0-100 scale, P < 0.03) for all stent locations. Both patients and physicians reported a significant reduction in all obstruction-related symptoms (>20 on the 0-100 scale, P < 0.006) after SEMS treatment. The physicians reported a larger mean improvement in symptoms than did the patients, mainly because they reported more severe symptoms before treatment.
SEMS treatment is effective in relieving symptoms of malignant GI and biliary obstruction, as reported by patients and physicians. The physicians, however, reported a larger reduction in obstructive symptoms than did the patients. A prospective assessment of patient-reported outcomes is important in evaluating SEMS treatment.
支架治疗的临床效果主要由医生进行评估；仅有少数前瞻性研究为此目的使用了患者报告的结果。本研究旨在通过患者报告的结果研究自膨式金属支架治疗恶性胃肠道梗阻的临床效果，并比较患者和医生对治疗效果的评价。
2006 年 11 月至 2008 年 4 月，从挪威的 9 家医院招募了 273 例接受 SEMS 治疗的恶性胃肠道和胆道梗阻患者。在治疗时和治疗后 2 周，患者和医生使用欧洲癌症研究与治疗组织（EORTC）QLQ-C30 问卷（补充与梗阻相关的特定问题）独立评估症状。
共有 162 例患者（99 例男性；中位年龄为 72 岁）完成了两次评估并纳入研究。所有支架位置的全球健康评分在 2 周后均显著改善（从 9 分提高到 18 分，0-100 分制，P < 0.03）。患者和医生均报告支架治疗后所有梗阻相关症状均显著减轻（0-100 分制>20 分，P < 0.006）。医生报告的症状改善均值大于患者，主要是因为他们在治疗前报告了更严重的症状。
SEMS 治疗可有效缓解恶性胃肠道和胆道梗阻的症状，患者和医生均有报告。然而，医生报告的梗阻症状减轻程度大于患者。前瞻性评估患者报告的结果对于评估 SEMS 治疗非常重要。
