Department of Colorectal Surgery, Swansea University Health Board, Swansea, UK
The School of Medicine, Swansea University, Swansea, UK.
BMJ Open. 2022 Jun 15;12(6):e056984. doi: 10.1136/bmjopen-2021-056984.
Approximately 5%-10% of new rectal cancers are locally advanced (locally advanced rectal cancer (LARC)) at presentation with 4%-8% recurring (locally recurrent rectal cancer (LRRC)) after initial treatment. Patients with potentially curable disease have to consider many trade-offs when considering major exenterative surgery. There are no decision tools for these patients and current resources have found to not meet minimum international standards. The overall aim of this study is to produce a validated patient decision aid (PtDA) to assist patients considering radical pelvic exenteration for LARC and LRRC created in line with international minimum standards.
This study is a national, multicentre mixed methods project and has been designed in keeping with guidance from the International Patient Decision Aids Standard.This study is in four stages. In stage 1, we will develop the PtDA and its content using agile developmental methodology. In stage 2, we will assess the content and face validity of the PtDA using mixed-methods with key stakeholders. In stage 3, we will assess the feasibility and efficacy of the PtDA. In stage 4, we will establish the barriers and facilitators to the use of a PtDA in the outpatient setting. Questionnaires including the QQ-10, EORTC PATSAT-C33, Preparation for Decision-Making Scale and the NoMAD survey will be analysed during the study. Interviews will be analysed using thematic analysis.
Research ethics approval from North of Scotland Research Ethics Service 19/NS/0056 (IRAS 257890) has been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through bowel research UK charity. External endorsement will be sought from the International Patient Decision Standards Collaboration inventory of PtDAs.
CRD42019122933.
大约有 5%-10%的新发直肠癌在初诊时已处于局部晚期（局部晚期直肠癌（LARC）），而在初始治疗后，有 4%-8%的患者会出现局部复发（局部复发性直肠癌（LRRC））。对于具有潜在治愈可能的患者，在考虑进行主要的根治性切除术时，需要考虑许多权衡因素。目前，这些患者没有决策工具，而且现有的资源也不符合最低国际标准。本研究的总体目标是制作一种经过验证的患者决策辅助工具（PtDA），以帮助考虑对 LARC 和 LRRC 进行根治性骨盆切除术的患者，同时符合国际最低标准。
这是一项全国性的、多中心的混合方法研究，其设计符合国际患者决策辅助工具标准的指导原则。本研究分为四个阶段。在第 1 阶段，我们将使用敏捷开发方法来开发 PtDA 及其内容。在第 2 阶段，我们将使用混合方法，结合关键利益相关者，评估 PtDA 的内容和表面有效性。在第 3 阶段，我们将评估 PtDA 的可行性和效果。在第 4 阶段，我们将确定在门诊环境中使用 PtDA 的障碍和促进因素。在研究过程中，我们将分析包括 QQ-10、EORTC PATSAT-C33、决策准备量表和 NoMAD 调查在内的问卷。访谈将采用主题分析法进行分析。
已获得苏格兰北部研究伦理服务处 19/NS/0056（IRAS 257890）的研究伦理批准。研究结果将在开放获取的同行评议期刊上发表，在会议上展示，并通过英国肠道研究慈善机构分发。将寻求国际患者决策标准协作库存的 PtDA 来对其进行外部认可。
CRD42019122933。
