Williams John, Russell Ian, Durai Dharmaraj, Cheung Wai Yee, Farrin Amanda, Bloor Karen, Coulton Simon, Richardson Gerry
Centre for Health Information, Research and Evaluation, School of Medicine, Swansea University, Swansea SA2 8PP.
BMJ. 2009 Feb 10;338:b231. doi: 10.1136/bmj.b231.
To compare the clinical effectiveness of doctors and nurses in undertaking upper and lower gastrointestinal endoscopy.
Pragmatic trial with Zelen's randomisation before consent to minimise distortion of existing practice.
23 hospitals in the United Kingdom. In six hospitals, nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 centres.
67 doctors and 30 nurses. Of 4964 potentially eligible patients, we randomised 4128 (83%) and recruited 1888 (38%) from July 2002 to June 2003.
Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy, undertaken with or without sedation, with the standard preparation, techniques, and protocols of participating hospitals. After referral for either procedure, patients were randomised between doctors and nurses.
Gastrointestinal symptom rating questionnaire (primary outcome), gastrointestinal endoscopy satisfaction questionnaire and state-trait anxiety inventory (all analysed by intention to treat); immediate and delayed complications; quality of examination and corresponding report; patients' preferences for operator; and new diagnoses at one year (all analysed according to who carried out the procedure).
There was no significant difference between groups in outcome at one day, one month, or one year after endoscopy, except that patients were more satisfied with nurses after one day. Nurses were also more thorough than doctors in examining the stomach and oesophagus. While quality of life scores were slightly better in patients the doctor group, this was not statistically significant.
Diagnostic endoscopy can be undertaken safely and effectively by nurses.
International standard RCT 82765705.
比较医生和护士进行上消化道和下消化道内镜检查的临床效果。
采用Zelen随机化的实用性试验，在获得同意前进行随机化以尽量减少对现有医疗行为的扭曲。
英国23家医院。在6家医院中，护士同时进行上消化道和下消化道内镜检查，共计29个中心。
67名医生和30名护士。在4964名潜在符合条件的患者中，我们于2002年7月至2003年6月随机选取了4128名（83%），招募了1888名（38%）。
采用参与医院的标准准备、技术和方案，进行诊断性上消化道内镜检查和乙状结肠镜检查，可使用或不使用镇静剂。在转诊进行任何一种检查后，患者在医生和护士之间随机分配。
胃肠道症状评分问卷（主要指标）、胃肠道内镜检查满意度问卷和状态-特质焦虑量表（均按意向性分析）；即刻和延迟并发症；检查质量和相应报告；患者对操作者的偏好；以及一年时的新诊断（均根据实施检查的人员进行分析）。
内镜检查后1天、1个月或1年时，两组之间的结果无显著差异，但患者在1天后对护士更满意。护士在检查胃和食管时也比医生更彻底。虽然医生组患者的生活质量评分略高，但无统计学意义。
护士可以安全有效地进行诊断性内镜检查。
国际标准随机对照试验82765705。
