Development and feasibility testing of a decision aid and a decision coaching programme on motherhood choice in multiple sclerosis - a mixed methods study

多发性硬化症(MS)是一种主要影响女性的慢性疾病，通常始于20至40岁之间。因此，母亲的选择是一个高度相关的话题，与许多相关的问题，如如何处理免疫疗法，怀孕是否影响疾病的过程，以及多发性硬化症是否会传染给孩子。这项计划的目标是为患有多发性硬化症的妇女开发和可行性测试怀孕决策支持工具和决策指导方案。基于开发和评估复杂干预措施的概念，将进行一项混合方法研究。在第一步中，将制定该方案，随后将使用定性方法进行可行性测试，随后将进行非随机试点研究。决策支持工具和指导方案将在已经评估的方案的基础上开发--一个关于免疫疗法的网络信息平台和一个关于免疫疗法的决策指导方案。针对上述主题，将开发基于证据的患者信息(EBPI)。EBPI将由另一个组成部分补充：要么是新开发的决策辅助(决策支持工具)，要么是护士领导的决策指导方案。可行性测试被理解为对内容的实用性和接受度的测试，分两个步骤进行。1)定性可行性测试：决策支持工具和指导计划将由选定的多发性硬化症护士、医生、专家患者和患有多发性硬化症的妇女使用定性方法(大声思考、回教)进行评估，并将根据反馈不断改进。2)非随机初步研究：初步研究的招募将在4个多发性硬化症中心进行。首先，对决策支持工具进行评估。16名妇女将在两周内获得EBPI，然后将被要求填写一份问卷，并通过电话参加面试。随后，将对决策指导方案方法进行评估。两名护士将接受决策指导的培训方案。随后，每名护士将通过电话或网络会议向来自不同中心的8名患有多发性硬化症的妇女提供咨询。女性将在教练之前获得EBPI的访问权限。他们将在辅导课程结束后完成问卷调查，并接受电话采访。作为关键终点，两组的决策冲突将被探索性地调查。将对定性数据进行专题分析。根据结果，可以决定哪种方法是最有前途的(决策指导方案或决策支持工具)，或者这两种方法是否应该在未来的随机对照试验中进一步采用，目的是评估方案可能的好处。

Multiple sclerosis (MS) is a chronic disease that mainly affects women and frequently starts between the age of 20 and 40 years. Therefore, motherhood choice is a highly relevant topic with many associated questions such as how to deal with immunotherapies, whether a pregnancy affects the course of the disease and whether MS is transmitted to children.The goal of this programme is the development and feasibility testing of a decision support tool and decision coaching programme on pregnancy for women with MS.A mixed-method study, based on the concept of developing and evaluating complex interventions, will be conducted. In the first step, the programme will be developed and subsequently a feasibility test will be carried out using qualitative methods followed by a non-randomised pilot study.The decision support tool and the coaching programme will be developed on the basis of already evaluated programmes - a web-based information platform on immunotherapies and a decision coaching programme on immunotherapies. An evidence-based patient information (EBPI) will be developed targeting the above mentioned topics. The EBPI will be supplemented by a further component: either a newly developed decision aid (decision support tool) or a nurse-led decision coaching programme. Physicians, MS-Nurses with coaching experience and experts patients will be involved in the development.The feasibility test is understood as a test of the practicability and acceptance of the content and takes place in two steps.1) Qualitative feasibility testing: The decision support tool and the coaching programme will be evaluated with selected MS Nurses, physicians, expert patients and women with MS using qualitative methods (think-aloud, teach-back) and will be continuously refined based on the feedback.2) Non-randomised pilot study: Recruitment for the pilot study will take place in 4 MS centres. First, the decision support tool will be evaluated. 16 women will have access to the EBPI for 2 weeks and will then be asked to fill out a questionnaire and to take part in an interview by telephone. Subsequently, the decision coaching programme approach will be evaluated. Two nurses will receive the training programme for decision coaching. Subsequently, each Nurse will counsel 8 women with MS from different centres via telephone or web conference. Women will gain access to the EBPI prior to the coaching. They will complete questionnaires after the coaching session and will be interviewed by telephone.As a key endpoint, the decisional conflict in both groups will be exploratively surveyed. Qualitative data will be analysed thematically.Based on the results, it can be decided which approach is the most promising (decision coaching programme or decision support tool) or whether both approaches should be pursued further in a future RCT, aiming to evaluate the programmes’ possible benefits.