DÄ internationalArchive6/2020The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease

Original article

The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease

Results from a randomized controlled trial (MERCED)

Dtsch Arztebl Int 2020; 117: 89-96. DOI: 10.3238/arztebl.2020.0089

Hüppe, A; Langbrandtner, J; Lill, C; Raspe, H

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.

LNSLNS

Medical rehabilitation (MR) is a “service for participation.” In Germany, the DRV (Deutsche Rentenversicherung, German Pension Insurance) is its most important funding agency. The aim of MR is “to prevent impairment on the earning capacity of insured persons or early withdrawal from professional life or to integrate them in professional life as permanently as possible“ (section 9 subsection 1 of Book VI of the German Social Code [SGB VI]).A further aim of MR is to avert, eliminate, mitigate or compensate for and prevent progression of impairing chronic diseases (section 42 subsection 1, SGB IX).

Anyone wishing to participate in an MR program must submit an application themselves, which the attending physician accompanies with a form-based medical opinion. The DRV reviews whether certain medical and legal requirements are met. With an approval rate of 83%, the DRV funded about 832 936 inpatient MR services for adults in 2018 (1), including 3687 services for insured persons with chronic inflammatory bowel disease (IBD), such as Crohn’s disease (CD) and ulcerative colitis (UC). The mean rehabilitation duration was 23 days. The services were usually provided in specialized facilities located far away from the usual place of residence of the patient (2).

CD and UC belong to the group of disorders in which multiple areas are usually affected during periods of high disease activity (3). In addition to physical impairments, patients experience psychosocial problems, such as poor sex life, dietary restrictions, stress, or depression) (4). Such complex problems require an equally complex care approach. This is the strength of inpatient MR: It is provided by a multidisciplinary team, “all under one roof“. Besides medical specialists, the MR team comprises nursing staff, psychologists, physiotherapists, sports therapists, and occupational therapists, as well as nutritionists, social workers, and vocational counsellors.

The German system of inpatient MR is nearly unique; no other country has a directly comparable system in place (5). Thus, the increasing amount of data from studies conducted in other countries (6) does not do away with the question of the effectiveness and benefits of the German MR system. In 2014, the German Advisory Council on the Assessment of Developments in the Health Care System stated: “In conclusion, the lack of an evidence base is the core problem of the entire (national) rehabilitation sector. Studies on the absolute effectiveness of existing rehabilitation measures are lacking.“ (7)

In the following, we report results of a randomized controlled trial (MERCED study) evaluating the effectiveness of inpatient medical rehabilitation compared to the continuation of routine care close to where the patient lives (absolute effectiveness). Participants were working persons with chronic inflammatory bowel disease covered by social insurance. Since the study included a number of pension funds and health insurances as well as several rehabilitation clinics, statements on the general effectiveness of MR can be made. The study is based on a design that has been gradually optimized since 2006 (8, 9, 10, 11). It allows—to the best of our knowledge for the first time for this indication—to compare inpatient MR with the continuation of ongoing standard care. Our approach was pragmatic (12, 13) and—by involving a patient advisory board– also participatory (14).

The aim of the project is to reduce the deplored evidence deficit for an exemplary indication and, in doing so, contribute to the evidence base for MR in terms of methodology and content. At the same time, it is intended to demonstrate the repeatedly doubted feasibility of conducting a randomized controlled trial (RCT) on the absolute effectiveness of inpatient MR.

Methods

(For detailed information, please refer to the eMethods Section).

Study design

The study was funded by the German Research Foundation (reference no.: RA 314/13–1) and conducted as a pragmatic, multicenter, parallel group, randomized controlled trial with two points of measurement (T0, T1) at an interval of twelve months.

Inclusion criteria and recruitment

Working DRV-insured patients aged from 18 to 63 years, who were members of one of the four participating statutory health insurances, were included in this study. All of these patients had at least two reports of incapacity for work because of Crohn’s disease (ICD-10 K50) or ulcerative colitis (K51) in their health insurance billing data. Their respective health insurance mailed them the study information and invitation provided by us. Interested insured persons contacted the study administration in Lübeck which sent them detailed study information as well as a questionnaire to assure they met the inclusion criteria and to document the baseline situation. Invited persons were excluded if they lacked the subjective need for rehabilitation, if they lacked at least one complicating psychosocial problem (4), if they stated not being able to participate in a rehabilitation program in the near future, if they had undergone MR in the past 2 years, and if informed consent was not provided.

Randomization and rehabilitation application

The included insurees were 1:1 randomized to the two arms of the study. The intervention group (IG) was supported by the study administration in preparing the rehabilitation application with written material, access to an additional information website, and individual counseling by phone/email. Using their “option” (“Wunsch- und Wahlrecht” of section 9 SGB IX; the right to individual wishes and choice), they were asked to select one of the 7 rehabilitation facilities listed by the patient organization DCCV (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung e. V., German Crohn’s Disease/Ulcerative Colitis Association). The standardized procedures for submitting a rehabilitation application, application review, application approval, and conduct of the rehabilitation program remained untouched.

The participants in the control group (CG) continued their previous treatment without any change. After the 12-month follow-up survey (T1), they received the study administration’s support offer.

Outcomes and measuring tools

The evaluation of the effectiveness of participation in medical rehabilitation was performed exclusively on the basis of patient-reported data from self-completion questionnaires. The primary outcome was the experienced limitation to participation in social life, measured using the index for measuring limitations in participation (IMET) (15, 16). Nine items are used to obtain data on limitations in various areas of everyday activities (including work, school, housework, leisure time, social relations) using numerical rating scales (0 = not impaired at all; 10 = completely impaired). The total score (0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90) was calculated based on these ratings.

In order to cover a broad range of potential rehabilitation effects, a total of 12 secondary outcomes were included and analyzed (Table 1).

Secondary outcomes
Table 1
Secondary outcomes

Data analysis

The primary analysis included all insured persons with data available for both points of measurement (complete case analysis, CCA). They were analyzed in the study arm to which they had been randomly allocated, regardless of their MR participation. Drop-out analyses were performed to estimate potential bias. A subgroup analysis compared IG participants who underwent an MR program during the study period with CG participants who did not undergo rehabilitation. During the sensitivity analysis for the primary outcome, data for all missing cases were imputed for an intention-to-treat (ITT) analysis, using various methods.

The significance level for the type 1 error was set at 5%. For the testing of the secondary outcomes, a Bonferroni correction was applied to adjust the significance level (24). For interval-scale outcomes, differences between T0 and T1 measurements were calculated for each participant and the mean differences (Δ T0−T1) between IG and CG were tested for significance using two-sided t-tests for independent samples. For nominal and ordinal data, the Chi-square test was used for significance testing. As effect sizes for continuous parameters, Cohen’s d was calculated, for dichotomous parameters odds ratios.

Patient advisory board

This participatory research project was supported by the patient organization DCCV e. V. and by an eight-member patient advisory board for the entire duration of the project. Its involvement ranged from stage 1 (consultation) to 3 (collaboration) of the 4-stage model described by Sweeney & Morgan (14); for example, the patient advisory board was involved in the selection of the outcomes.

Ethics Committee and registration

The study was approved by the Ethics Committee of the University of Lübeck (reference number 16–047 of 8 March 2016) and registered with the German Registry of Clinical Studies (DRKS00009912).

Results

Study sample

Of the 4359 insured persons informed about the study, 1144 requested detailed study information. 228 of the 758 insured persons willing to participate did not meet the inclusion criteria. 530 insured persons were included in the study and randomized to IG (268) or CG (262). The recruitment target was set at 300 patients in each study arm. Twelve months later, 431 study participants filled in the follow-up questionnaire. The drop-out rate for the interval between study inclusion and follow-up survey was 21.3% (57 of 268) and 16% (42 of 262) in the IG and the CG, respectively (p = 0.122) (Figure).

Flowchart of the study procedure
Figure
Flowchart of the study procedure

The baseline characteristics of the analysis group are listed in Table 2.

Sample characteristics at baseline (complete cases: N = 431)
Table 2
Sample characteristics at baseline (complete cases: N = 431)

In a drop-out analysis, the 99 drop-outs were compared with the 431 patients who participated in the follow-up survey. Only for the parameter “disease duration,” a significant difference was found: The disease duration among the drop-outs was 3 years shorter on average (eTable 1).

Drop-out analysis—baseline survey data
eTable 1
Drop-out analysis—baseline survey data

Application advice and rehabilitation participation

All participants in the IG received the written information pack; in addition, 28% (59 of 211) also made use of the website. 43% (90 of 211) approached the study administration directly with questions about the application process, either by phone or email.

112 (53.1%) of the IG members reported to have undergone a rehabilitation program which had been conducted in 81% in one of the 7 recommended rehabilitation facilities. The MR was performed about 4 months (median) after the baseline survey (interquartile range: 3–6 months).

In the CG, 15 patients (6.8%) had undergone MR between T0 and T1.

Complete case analysis for primary and secondary outcomes

The complete case analysis (N = 431) showed statistically significant advantages for the primary outcome in the IG (Table 3): The experienced limitation in social participation was reduced in the IG by 7.3 (SD = 21.1), in the CG by 2.9 (SD = 17.3) points (p = 0.018); this corresponds to a small effect size of d = 0.23. A clinically relevant improvement by 10 points in the IMET was achieved by 43.8% and 32.1% in the IG and CG, respectively (p = 0.013). The statistically significant advantage in the primary outcome for the IG was confirmed by the additional ITT analysis (eMethods, eTable 2).

Results of the complete case analysis (IG: N = 211; CG: N = 220)
Table 3
Results of the complete case analysis (IG: N = 211; CG: N = 220)
Additional ITT analysis for the primary outcome (limitation in social participation) using various imputation methods
eTable 2
Additional ITT analysis for the primary outcome (limitation in social participation) using various imputation methods

Likewise, in 6 of the 12 secondary outcomes, significant advantages for the IG were found after alpha-error adjustment (p-values ≤ 0.004). The largest effect size (d = 0.37) was demonstrated for disease activity (reduction in the GIBDI [German Inflammatory Bowel Disease Activity Index] by 1.4 and 0.3 points in the IG and CG, respectively; p<0.001); at the time of the follow-up survey, 51.2% and 36.1% of the patients were in remission in the IG and CG, respectively (GIBDI ≤ 3) (p = 0.002), including steroid-free remission: 41.1% versus 29.5% (p = 0.017). In 2 of the 3 documented self-management aspects, the IG showed greater improvements; similarly, the increase in vitality and health-related quality of life was more pronounced in the IG (effect sizes around 0.3). In the direct measurement of change at the time of the follow-up survey, 58% and 35% showed an improved health status in the IG and CG, respectively (p<0.001).

In the other secondary outcomes, differences between IG and CG were not significant, but more favorable developments were also apparent in the IG, also in terms of constructive attitudes, level of being informed, and mental stress. The differences in the work-related outcomes were non-significant and irrelevant from a social medicine perspective.

Subgroup analysis (rehabilitants in the IG versus non-rehabilitants in the CG)

In addition to the primary analysis, only rehabilitants of the IG (N = 112) were compared to the non-rehabilitants of the CG (N = 205). At baseline, the two groups did not differ from each other (eTable 3). The rehabilitants of the IG achieved significantly better scores with larger (up to medium) effect sizes in all primary outcomes as well as all secondary outcomes, with the exception of work-related outcomes (eTable 4).

Sample characteristics at baseline (subgroup analysis: rehabilitants in IG versus non-rehabilitants in CG)
eTable 3
Sample characteristics at baseline (subgroup analysis: rehabilitants in IG versus non-rehabilitants in CG)
Results of the subgroup analysis (IG: 112 rehabilitants versus CG: 205 non-rehabilitants)
eTable 4
Results of the subgroup analysis (IG: 112 rehabilitants versus CG: 205 non-rehabilitants)

Utilization of healthcare services outside the rehabilitation sector

Patients in the IG and CG provided information about the utilization of the outpatient and inpatient healthcare sector before and during the study. No differences were found with regard to the type and frequency of consultation with specialists, the use of various medications and the use of rehabilitative services at the place of residence (eTable 5).

Treatment outside the rehabilitation sector (complete cases)
eTable 5
Treatment outside the rehabilitation sector (complete cases)

Discussion

MERCED evaluated the effectiveness of inpatient MR for working persons with statutory health insurance suffering from IBD who at that time stated that they were in need of rehabilitation and prepared to undergo rehabilitation. The pragmatically designed RCT had no influence on the procedures of the rehabilitation funding authorities and the rehabilitation clinics.

Our analyses suggest that inpatient MR for this indication is of general and absolute effectiveness and benefit. The hypothesis of its specific effectiveness is supported by the finding that there were no differences between IG and CG patients’ utilization of other medical services, neither before nor after MR.

In the complete case analysis, the primary outcome and most secondary outcomes showed significantly higher levels of improvement in the IG compared to the CG. The effect sizes achieved were in the smaller range. Clinically relevant improvement in social participation and steroid-free remission were significantly more frequently observed in the IG compared to the CG. The subgroup analysis comparing rehabilitants (IG) with non-rehabilitants (CG) found numerically larger effect sizes; this also indicates specific effectiveness. Neither of the two analyses showed significant advantages for the IG in terms of the strictly socio-medical outcome parameters (employment status, subjective employment prognosis, number of sick days taken off from work). This finding will have to be addressed in a separate publication. It should be noted that staying in or returning to work is not the sole purpose of DRV-financed MR (25). In patients with IBD, MR appears to be most effective in terms of clinical and psychosocial outcomes.

Our study shows that randomized controlled trials can be conducted to evaluate the absolute general effectiveness of MR—contrary to opinions expressed for decades (26, 27, 28). To this end, recruitment was carried out with full disclosure to the target persons before they submitted their application for rehabilitation. The EPRA study, which was carried out almost at the same time, used an alternative approach: It randomized asthma patients after their rehabilitation applications had been approved to either immediate or delayed start of rehabilitation (29). Due to strong rehabilitation preferences of the recruited patients, it can be assumed that such a waiting group design (30) only allows the evaluation of short-term effects of MR. The situation before submission of a rehabilitation application is different. Frequently, these IBD patients—and their physicians—express doubt about the effectiveness and sustainability of MR. By proactively approaching insured persons who had previously been selected by their health insurances and who continued to select themselves, participants were found who were prepared to postpone a rehabilitation application by one year.

Limitations and weaknesses of the MERCED study

In the MERCED study, the strategy of proactively approaching insured persons potentially in need of rehabilitation may have brought a patient group to MR which is not normally seen there. However, the fact that the patient population of the MERCED study is more similar in its characteristics to other samples recruited in rehabilitation clinics (31, 32) than to IBD samples from outpatient care (33, 34) supports the appropriateness of the approach (eTable 6). Only in the area of school education is there an obvious difference: The proportion of patients with lower school education (max. 9 years) is smaller in the MERCED study. This most likely reflects the structure of the persons insured by the recruiting health insurances (35).

Comparison of the MERCED sample with other IBD study samples
eTable 6
Comparison of the MERCED sample with other IBD study samples

In the period between T0 and T1, about 20% of the randomized insured persons were lost to follow-up; these were not included in our complete case analysis. While no evidence of bias was found in the drop-out analysis, such bias cannot be excluded. A further weakness lies in the lack of clinical confirmation of the diagnosis. Instead, two incapacity for work certificates with matching ICD coding in the health insurance data and the self-declaration of a medically confirmed IBD were required for inclusion.

In all cases, these were conditions and changes reported by the insured persons; health insurance data on incapacity for work were not available as originally planned.

For every participant, the second survey was conducted almost exactly twelve months after the first. The follow-up period after the end of medical rehabilitation, on the other hand, was not uniform in the IG. The median duration was 8 months (interquartile range: 6; 9). This is due to differences in the length of the interval between rehabilitation application and approval and start of rehabilitation.

Instead of the target of at least 60%, only 53% (112 of 211) of the IG patients participating until the end of the study completed a medical rehabilitation program (see Figure). It is therefore all the more remarkable that the analyses consistently indicated significant and relevant, albeit weak, advantages for the IG.

In summary, this pragmatic, randomized, standard care–controlled trial generated evidence on the effectiveness and additional benefit of inpatient MR in working persons with statutory health insurance suffering from IBD which we think is convincing. There is little doubt that the greater improvements observed in the IG can be attributed to MR. However, the mechanisms of action of this highly complex intervention cannot be determined with this study design. Also unanswered remains the question of the cost-effectiveness of MR. Further comparable studies on this and other indications should be conducted — including studies with controlled variation of the rehabilitation program.

Acknowledgement

We thank the statutory health insurances AOK-Nordost, BARMER, Novitas BKK, and TK as well as their insurees for their willingness to support this health services research project by participating in the study. Our thanks also go to the project and patient advisory boards for their helpful support of this study project.

Data sharing

Scientists who submit a methodologically useful analysis proposal may, after anonymization, be provided with individual participant data (including metadata) on which the results presented in this paper are based. Three months after publication, these data will be available for a period of 3 years. Interested researchers may contact the first author.

Conflict of interest statement
The authors declare that no conflicts of interest exist.

Manuscript received on 10 July 2019; revised version accepted on 28 November 2019

Translated from the original German by Ralf Thoene, MD.

Corresponding author
Dr. phil. Angelika Hüppe
Institut für Sozialmedizin und Epidemiologie
Universität zu Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
angelika.hueppe@uksh.de

Cite this as:
Hüppe A, Langbrandtner J, Lill C, Raspe H: The effectiveness of actively induced medical rehabilitation in chronic inflammatory bowel disease—results from a randomized controlled trial (MERCED).
Dtsch Arztebl Int 2020; 117: 89–96. DOI: 10.3238/arztebl.2020.0089

Supplementary material

For eReferences please refer to:
www.aerzteblatt-international.de/ref0620

eMethods Section, eTables:
www.aerzteblatt-international.de/20m0089

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e10.
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e11.
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Institute of Social Medicine and Epidemiology, University of Lübeck:
Dr. phil. Angelika Hüppe, Dr. human biol. Jana Langbrandtner, Cassandra Lill M.A.
Center for Population Medicine and Health Services Research, University of Lübeck:
Prof. Dr. med. Dr. phil. Heiner Raspe
Flowchart of the study procedure
Figure
Flowchart of the study procedure
Key messages
Secondary outcomes
Table 1
Secondary outcomes
Sample characteristics at baseline (complete cases: N = 431)
Table 2
Sample characteristics at baseline (complete cases: N = 431)
Results of the complete case analysis (IG: N = 211; CG: N = 220)
Table 3
Results of the complete case analysis (IG: N = 211; CG: N = 220)
Drop-out analysis—baseline survey data
eTable 1
Drop-out analysis—baseline survey data
Additional ITT analysis for the primary outcome (limitation in social participation) using various imputation methods
eTable 2
Additional ITT analysis for the primary outcome (limitation in social participation) using various imputation methods
Sample characteristics at baseline (subgroup analysis: rehabilitants in IG versus non-rehabilitants in CG)
eTable 3
Sample characteristics at baseline (subgroup analysis: rehabilitants in IG versus non-rehabilitants in CG)
Results of the subgroup analysis (IG: 112 rehabilitants versus CG: 205 non-rehabilitants)
eTable 4
Results of the subgroup analysis (IG: 112 rehabilitants versus CG: 205 non-rehabilitants)
Treatment outside the rehabilitation sector (complete cases)
eTable 5
Treatment outside the rehabilitation sector (complete cases)
Comparison of the MERCED sample with other IBD study samples
eTable 6
Comparison of the MERCED sample with other IBD study samples
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