Institute of Social Medicine and Epidemiology, University of Lübeck; Center for Population Medicine and Health Services Research, University of Lübeck.
Dtsch Arztebl Int. 2020 Feb 7;117(6):89-96. doi: 10.3238/arztebl.2020.0089.
The poor evidence base is a major problem for the German rehabilitation sector. This trial focused on testing the efficacy and benefit of inpatient medical rehabilitation compared to routine care in a single common entity, namely, chronic inflammatory bowel disease (IBD).
This pragmatic, multicenter, randomized controlled trial with a parallel group design included gainfully employed patients with IBD who were covered by one of four statutory health insurance providers. Patients in the intervention group were actively advised regarding options for rehabilitation and given support in applying for it; patients in the control group continued with the care they had been receiving before participation in the trial. The primary endpoint was social participation, and there were various secondary endpoints, including disease activity and sick days taken off from work. All parameters were assessed by questionnaire at the beginning of the trial and twelve months later. This was trial no. DRKS00009912 in the German clinical trials registry.
In a complete case analysis, the intervention group (211 patients, of whom 112 underwent rehabilitation) did better than the control group (220 patients, of whom 15 underwent rehabilitation) in multiple respects. The reported limitation in social participation was reduced by 7.3 points in the intervention group and 2.9 points in the control group (p = 0.018; d = 0.23). Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4. No benefit was seen in outcomes related to working capacity. Sensitivity analyses lent further support to the findings.
Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of ied rehabilitation for IBD patients, as well as its additional benefit compared to routine care.
德国康复领域的主要问题是证据基础薄弱。本试验重点测试了住院医疗康复与常规护理相比，在单一实体（即慢性炎症性肠病[IBD]）中的疗效和益处。
这是一项具有平行组设计的实用、多中心、随机对照试验，纳入了有工作的 IBD 患者，这些患者由四家法定健康保险公司之一承保。干预组的患者接受了关于康复选择的积极建议，并在申请康复方面得到了支持；对照组的患者继续接受他们在参加试验前接受的治疗。主要终点是社会参与度，还有其他几个次要终点，包括疾病活动度和因疾病缺勤天数。所有参数均在试验开始时和 12 个月后通过问卷进行评估。这是德国临床试验注册中心的 DRKS00009912 号试验。
在完全案例分析中，干预组（211 例患者，其中 112 例接受康复治疗）在多个方面的表现优于对照组（220 例患者，其中 15 例接受康复治疗）。干预组报告的社会参与受限减少了 7.3 分，对照组减少了 2.9 分（p=0.018；d=0.23）。疾病活动度、活力、健康相关生活质量和自我管理也有显著改善，效应大小在 0.3 到 0.4 之间。与工作能力相关的结果没有改善。敏感性分析进一步支持了这些发现。
可以对个体化随机对照试验进行康复研究。本试验的结果表明，针对 IBD 患者的个体化康复具有绝对有效性，与常规护理相比，还具有额外的益处。
