Wu Robert, Boushey Robin, Potter Beth, Stacey Dawn
The Ottawa Hospital General Campus, 501 Smyth Rd,, Ottawa, Ontario K1H 8L6, Canada.
BMC Surg. 2014 Mar 21;14:16. doi: 10.1186/1471-2482-14-16.
Colorectal cancer is common in North America. Two surgical options exist for rectal cancer patients: low anterior resection with re-establishment of bowel continuity, and abdominoperineal resection with a permanent stoma. A rectal cancer decision aid was developed using the International Patient Decision Aid Standards to facilitate patients being more actively involved in making this decision with the surgeon. The overall aim of this study is to evaluate this decision aid and explore barriers and facilitators to implementing in clinical practice.
First, a pre- and post- study will be guided by the Ottawa Decision Support Framework. Eligible patients from a colorectal cancer center include: 1) adult patients diagnosed with rectal cancer, 2) tumour at a maximum of 10 cm from anal verge, and 3) surgeon screened candidates eligible to consider both low anterior resection and abdominoperineal resection. Patients will be given a paper-version and online link to the decision aid to review at home. Using validated tools, the primary outcomes will be decisional conflict and knowledge of surgical options. Secondary outcomes will be patient's preference, values associated with options, readiness for decision-making, acceptability of the decision aid, and feasibility of its implementation in clinical practice. Proposed analysis includes paired t-test, Wilcoxon, and descriptive statistics. Second, a survey will be conducted to identify the barriers and facilitators of using the decision aid in clinical practice. Eligible participants include Canadian surgeons working with rectal cancer patients. Surgeons will be given a pre-notification, questionnaire, and three reminders. The survey package will include the patient decision aid and a facilitators and barriers survey previously validated among physicians and nurses. Principal component analysis will be performed to determine common themes, and logistic regression will be used to identify variables associated with the intention to use the decision aid.
This study will evaluate the impact of the rectal cancer decision aid on patients and help with planning strategies to overcome barriers and facilitate implementation of the decision aid in routine clinical practice. To our knowledge this is the first study designed to evaluate a decision aid in the field of colorectal surgery.
结直肠癌在北美很常见。直肠癌患者有两种手术选择：低位前切除术并重建肠道连续性，以及腹会阴联合切除术并形成永久性造口。利用国际患者决策辅助标准开发了一种直肠癌决策辅助工具，以帮助患者更积极地参与与外科医生共同做出这一决策。本研究的总体目标是评估这一决策辅助工具，并探索在临床实践中实施的障碍和促进因素。
首先，一项前后对照研究将以渥太华决策支持框架为指导。来自结直肠癌中心的符合条件的患者包括：1）被诊断为直肠癌的成年患者；2）肿瘤距肛缘最大10厘米；3）经外科医生筛选，有资格考虑低位前切除术和腹会阴联合切除术的患者。将为患者提供决策辅助工具的纸质版和在线链接，以便在家中查看。使用经过验证的工具，主要结局将是决策冲突和手术选择的知识。次要结局将包括患者的偏好、与选择相关的价值观、决策准备情况、决策辅助工具的可接受性以及在临床实践中实施的可行性。拟进行的分析包括配对t检验、威尔科克森检验和描述性统计。其次，将进行一项调查，以确定在临床实践中使用决策辅助工具的障碍和促进因素。符合条件的参与者包括治疗直肠癌患者的加拿大外科医生。将提前通知外科医生，并向其发放问卷以及三次提醒。调查问卷包将包括患者决策辅助工具以及先前在医生和护士中验证过的促进因素和障碍调查问卷。将进行主成分分析以确定共同主题，并使用逻辑回归来识别与使用决策辅助工具的意愿相关的变量。
本研究将评估直肠癌决策辅助工具对患者的影响，并有助于制定策略以克服障碍并促进决策辅助工具在常规临床实践中的实施。据我们所知，这是第一项旨在评估结直肠外科领域决策辅助工具的研究。
