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

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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.