Medical rehabilitation in inflammatory bowel disease: effective and needed? A randomised controlled health care trial in a paradigmatic indication

早在1989年，德国联邦政府就批评康复医学的科学基础不足。到目前为止，任何相关的事情似乎都没有改变。2014年，国家卫生保健咨询委员会(SVR Gesundheit)宣布，仍然缺乏证据基础是整个康复部门的核心问题。我们开发和巩固了一个设计(我们发现)适合于在一个典型的适应症中测试医疗康复的总体绝对有效性。我们选择炎症性肠病(IBD)作为一个典型的适应症，这是近年来我们社会医学研究的一个焦点。几种法定健康保险(GKV)的管理数据作为参与式实用RCT的样本花名册：住院医疗康复与常规护理。大约500名被医学诊断为IBD、有主观康复需求、愿意申请康复以及(即将)职业参与限制的成员将被随机抽查。强烈建议干预组成员申请康复。该申请(以及在适当的情况下任何上诉)都得到积极的支持。控制组和所有其他管理例程保持不变。主要结果是病例和工作残疾天数(GKV数据)和自我报告的社会参与(IMET量表)。次要结果包括工作能力指数(WAI)。在基线和12个月后评估结果。如果成功，我们的随机对照试验为医疗康复中进一步迫切需要的有效性研究提供了蓝图。这一结果将有可能支持该卫生保健部门对IBD患者的优先排序，并完善现有的实践指南。

As early as in 1989 the German Federal Government critically remarked on the insufficient scientific foundation of rehabilitation medicine. Up to now nothing relevant seems to have changed. In 2014, the national Advisory Council on Health Care (SVR Gesundheit) declared the still lacking evidence base as the core problem of the entire rehab sector. We developed and consolidated a design (we find) appropriate for testing the general absolute effectiveness of medical rehab in a paradigmatic indication. We choose inflammatory bowel diseases (IBD) as a paradigmatic indication, a focus of our socio-medical research in recent years. The administrative data of several statutory health insurances (GKV) serve as sampling roster of a participatory pragmatic RCT: in-patient medical rehab vs. usual care. About 500 members with medically diagnosed IBD, subjective rehab needs, willingness to apply for rehab, and (imminent) vocational participation restriction will be randomised. Members of the intervention group are intensively advised to apply for rehab. The application (and if appropriate any appeal) is as actively supported. The control group and all other administrative routines remain untouched. Primary outcomes are cases and number of days of work disability (GKV data) and self-reported social participation (IMET scale). Secondary outcomes include the Work Ability Index (WAI). Outcomes are assessed at baseline and after 12 months. If successful our RCT provides a blueprint for further urgently needed effectiveness studies in medical rehab. The results will potentially be able to support prioritisation of IBD patients in this health care sector and complete existing practice guidelines.