The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease (MERCED Study), 2020, Hüppe et al.

Hüppe A, Langbrandtner J, Lill C, Raspe H. The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease. Dtsch Arztebl Int. 2020 Feb 7;117(6):89-96. doi: 10.3238/arztebl.2020.0089. PMID: 32102728; PMCID: PMC7075457.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075457/

Abstract

Background
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).

Methods
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.

Results
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.

Conclusion
Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of medically qualified rehabilitation for IBD patients, as well as its additional benefit compared to routine care.

 

The German Network for evidence-based medicine awarded this study with the David Sackett Prize 2021:

David Sackett Award 2021 for a randomized-controlled trial in the field of rehabilitation science

"The CED Project Group at the Center for Population Medicine and Health Services Research at the University of Lübeck receives the EbM Network Science Award for its research findings on the efficacy and benefits of actively induced medical rehabilitation in inflammatory bowel disease (MERCED Study)"

Press release (PDF, in German)
https://www.ebm-netzwerk.de/de/veroeffentlichungen/pdf/pm-sackett-preis-20210225.pdf

Google translate (PDF)

 

Not upto reading the full paper this evening, but is the abstract indicating improvement of self reported measures, but no improvement on objective outcomes?

 

I get the impression that in the UK this study would be considered unethical. One group were advised how to get rehab and the others were not. For those in the rehab group to bother they would have to be told rehab was good. The other group would have to be told something different. Maybe I have not got the right idea but it sounds weird.

Doing trials like this might be a way to overcome certain problems but the set up seems particularly strange.

I am not sure why they needed any rehab anyway.
There is strong sense to me that this is a way of getting evidence to support financing the authors beloved rehab business.

 

If this is good enough research to warrant a prize, then it would truly be for the greater good to shut all this nonsense down, especially for the people working in this.

It's as if the lessons that gave way to the scientific method were a distant long-forgotten dream of some sort, going back to the old ways of trying random stuff and cherry-picking whatever number gives them something to argue.