Inflammatory bowel disease (IBD) patients with impaired quality of life on biologic therapy benefit from the support of an IBD nurse specialist: Results of a randomised controlled trial in Germany (IBDBIO-ASSIST study).

BACKGROUND: IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care provided by IBD nurse specialists in Germany in improving health-related quality of life (QoL) in IBD patients on biologic therapy. AIM: To evaluate patient-related outcomes and economic consequences associated with integrating IBD nurses into usual care. METHODS: We randomly assigned 1086 patients with IBD on biologic therapy to a control group (CG) receiving usual care or an intervention group (IG) receiving additional care from an IBD nurse specialist. The primary outcome was disease-specific QoL (sIBDQ) assessed at 6, 12 and 18 months. RESULTS: At baseline, patients in both groups were highly satisfied with their treatment situation and had relatively high sIBDQ values (range: 1-7; CG: 5.12; IG: 4.92). In the intention-to-treat (ITT) analysis of the overall sample, there was no significant difference in sIBDQ between groups at the assessment time points. However, a per-protocol analysis of patients with impaired QoL at baseline (EQ-VAS < 75 [median]), showed improvement in sIBDQ over 6 months that became significant at month 12 and remained significant through month 18 (baseline: IG 4.24; CG 4.31; 18 months: IG 5.02; CG 4.76; p = 0.017). CONCLUSION: High baseline satisfaction of IBD patients with treatment and the relatively high baseline sIBDQ values may have contributed to the lack of significant difference in sIBDQ scores for the overall sample. However, patients with impaired QoL derived significant benefit from additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term.

[Work Participation after Multimodal Rehabilitation due to Diseases of the Digestive System. Representative Analyses using Routine Data of the German Pension Insurance]. / Berufliche Teilhabe nach einer medizinischen Rehabilitation aufgrund von Erkrankungen des Verdauungssystems. Repräsentative Analysen auf Basis der Routinedaten der Deutschen Rentenversicherung.

PURPOSE: Diseases of the digestive system such as Crohn's disease (CD) or ulcerative colitis (UC) are associated with problems in occupational participation, but they only make up a very small part of all rehabilitation services provided by the German Pension Insurance. Rehabilitation is a very good treatment option, but its effectiveness is largely unclear. So far, several studies exist on the return to work after medical rehabilitation. However, representative findings and the relevant influencing factors are still lacking. This is the aim of the present analysis. METHODS: We used the rehabilitation statistics database of the German Pension Insurance. Patients were included with completed medical rehabilitation due to a disease of the digestive system in 2017. The analyses were carried out for the entire group as well as differentiated according to the diagnosis groups CD, UC, diverticular diseases (DI) as well as pancreatic diseases (PA). Occupational participation was operationalised both via a monthly information up to 24 months after rehabilitation and as a rate of all persons who were employed after 12 or 24 months in the survey month and the 3 preceding months. For the analysis of the influencing factors on stable occupational participation, multiple logistic regression models with stepwise inclusion were calculated separately for the rates after 12 and 24 months. RESULTS: A total of 8,795 data sets were included in the analysis (CD: n=1,779, 20%; UC: n=1,438, 16%; DI: 1,282, 15%; PA: n=761, 9%). The average age in the groups ranged from 44 (CD) to 54 (DI) years; the proportion of women ranged from 28% (PA) to 57% (CD). Between 16% (DI) and 32% (PA) of the rehabilitation participants had sickness absences of 6 or more months in the year before rehabilitation. Two years after rehabilitation, the return-to-work rates were 69% (CD), 71% (UC), 68% (DI) and 58% (PA). The strongest influencing factors on stable occupational participation were time of sick leave and wage before rehabilitations well as work ability at admission. CONCLUSION: Two years after gastroenterological rehabilitation in Germany, 6 to 7 out of 10 affected persons return to stable work participation. Relevant influencing factors are the time of sick leave and the level of remuneration. The results support an expansion of rehabilitation concept to include work-related aspects.

[Assessment of Psychosocial Problems in Inflammatory Bowel Diseases - Who Uses the Online Version at www.CED-aktiv-werden.de?] / Psychosoziales Problemfeld-Assessment bei chronisch entzündlichen Darmerkrankungen ­ wer nutzt die online-Version unter www.CED-aktiv-werden.de?

AIM OF THE STUDY: Taking into consideration and addressing patients' psychosocial problems is one of the characteristics of good clinical practice; this applies to IBD-patients as well. Since 2014, such patients have been offered an online questionnaire-based problem assessment linked to care recommendations. The primary aim of our data analysis was to carry out a comparative description of socio-demographic and disease-related characteristics of users of the free service. METHODOLOGY: For a retrospective data analysis, the online sample (OG) comprising 2156 CD and UC patients was compared with 852 individuals who participated in 2 IBD health services research studies (CG). Besides descriptive statistics, regression and covariance analyses were carried out. RESULTS: The OG differed from CG in a highly significant and partly clinically relevant way. One in 3 of the OG was younger than 30 years of age (CG: 19%); 45% had completed high school (CG: 36%). In the OG, fewer were in disease remission (OG 34%; CG 59%). Even controlling for these differences, the OG reported more often greater burden in 12 of 17 psychosocial problem areas and expressed a greater need for information on 5 of 9 disease-related topic areas. CONCLUSION: The internet-based assessment of psychosocial problems is used primarily by younger, better educated, and physically as well as psychosocially more burdened IBD patients with comparatively high information needs. The assessment may help them to actively participate in their care. Our data sheds further light on the peculiarities of internet-based study groups.

[Inflammatory Bowel Disease - Challenges in the Workplace and Support for Coping with Disease]. / Erwerbstätig mit chronisch entzündlicher Darmerkrankung ­Herausforderungen im Arbeitsleben und unterstützende Maßnahmen zur Bewältigung.

PURPOSE: Patients with inflammatory bowel diseases (IBD) are often impaired in their ability to be employed due to IBD symptoms. The aim of this study was to explore work-related problems and support requested by IBD patients and develop rehabilitation programs meeting their needs. METHODS: A total of 235 IBD patients (97 rehabilitants, 138 outpatients) completed a questionnaire assessing disease-specific impairments, work-related concerns and the need for support services. Subjective work disability was determined with the SPE scale. RESULTS: Participants were on average 46 years old, 60% were women, 45% suffered from Crohn's disease and 67% worked full-time; 72% (n=170) had a negative subjective prognosis of gainful employment. Participants reported an average of 12 disease-specific and 22 work-related problems. About 50% of the participants reported disease-specific problems, namely fatigue (66%), weakness (55%) and urge to pass stool (55%). The three most common work-related problems affecting more than 50% of the respondents almost every day were reduced work ability (56%), worrying about not being fully efficient (55%) and stress at work (53%). Support services requested were counselling for information on the disease (91%), treatment options (88%), social law benefits (85%) and exercises to increase physical fitness (84%). CONCLUSION: The wide range of work-related physical and psychosocial impairments affecting IBD patients reveals a need to extend current rehabilitation services, with a stronger occupational focus and to implement a standardized screening for work-related problems. Disease-specific support services can be developed and addressed in a multimodal and interdisciplinary setting such as the rehabilitation sector.

[Medical Rehabilitation for Inflammatory Bowel Disease: Access, Process, and Results - Further Analyses of a Randomised Controlled Trial]. / Medizinische Rehabilitation bei chronisch entzündlichen Darmerkrankungen: Zugang, Prozess und Ergebnisse.

BACKGROUND: MERCED is a pragmatic randomised health care trial on the effectiveness and benefit of medical rehab in socially insured employees with chronic inflammatory bowel disease. After on average 8 months post rehab the intervention group showed, compared to continued routine care, a moderate but clinically relevant additional benefit in indicators of social participation, clinical and psychological status. However, no differences were observed for employment status, days off work, and subjective vocational prognosis. METHODS: We used questionnaire-based reports and ratings of the 211 members of the intervention group on access to medical rehab, its processes and subjective global success as well as a range of health effects calculating pre-post differences. RESULTS: Contact with three employment/work related services (focused on vocational counselling, legal advice, aftercare) were reported by 33, 48, and 23% resp. of all rehab patients. Patients with pronounced vocational problems had equally frequent contacts as those without. Compared to 12 other services the three received inferior ratings on a scale from 1 (very good) to 5 (very bad): mean 2,5 - 2,3 - 3,0 resp. CONCLUSION: Medical rehab's relative neglect of vocational elements may partially explain its ineffectiveness in improving participation in work and employment. From MERCED's procedures and results we inferred recommendations to intensify access to medical rehab and its vocational orientation and evaluate its effects.

[Work-Related Problems and Requested Support in Inflammatory Bowel Disease - Results of a Multi-Perspective Survey]. / Berufsbezogene Problemlagen und erwünschte Unterstützungsangebote bei chronisch entzündlichen Darmerkrankungen.

PURPOSE: Patients with inflammatory bowel diseases (IBD) are often impaired in their occupational participation and ability to work due to IBD-symptoms and complex psychosocial problems. The aim was to explore work-related problems and requested support of IBD-patients and to develop adequate occupational-oriented offers in rehabilitation with a multi-perspective approach. METHODS: Guided interviews with employed IBD-patients in medical rehabilitation at 2 measurement points (N=12), guided interviews with employed IBD-patients in specialist gastroenterological care (N=7), 4 focus group interviews with rehabilitation staff (N=27) and expert interviews (N=8) were conducted. The qualitative data have been examined in MAXQDA using content-structuring qualitative content analysis. RESULTS: The 4 different interview groups report a similar spectrum of work-related problems and describe various somatic and psychosocial impairments in the working life of IBD-patients. Physical as well as cognitive impairments, fatigue, pain and psychosocial barriers, which are often associated with reduced productivity at work, are described. Additional restrictions result from unhealthy behaviour at work. The results show an increased need for rehabilitative occupational-oriented offers. IBD patients want a more work-related orientation of rehabilitative offers. They ask for competence-promoting offers to develop specific working skills and coping strategies to maintain their ability to work. CONCLUSION: The results highlight the range of work-related problems of IBD-patients and show occupational-oriented support opportunities and potentials in rehabilitation sector. Medical rehabilitation must be more tailored to the needs of working IBD-patients and should be more focused on health-related challenges at work. A stronger occupational focus, standardised screening for work-related problems and a competence-promoting orientation of IBD-rehabilitation could enhance the spectrum of rehabilitation offers and maintain the ability to work.

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

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 ied rehabilitation for IBD patients, as well as its additional benefit compared to routine care.

Prognostic ability of the German version of the STarT Back tool: analysis of 12-month follow-up data from a randomized controlled trial.

BACKGROUND: Stratified care is an up-to-date treatment approach suggested for patients with back pain in several guidelines. A comprehensively studied stratification instrument is the STarT Back Tool (SBT). It was developed to stratify patients with back pain into three subgroups, according to their risk of persistent disabling symptoms. The primary aim was to analyse the disability differences in patients with back pain 12 months after inclusion according to the subgroups determined at baseline using the German version of the SBT (STarT-G). Moreover, the potential to improve prognosis for disability by adding further predictor variables, an analysis for differences in pain intensity according to the STarT-Classification, and discriminative ability were investigated. METHODS: Data from the control group of a randomized controlled trial were analysed. Trial participants were members of a private medical insurance with a minimum age of 18 and indicated as having persistent back pain. Measurements were made for the risk of back pain chronification using the STarT-G, disability (as primary outcome) and back pain intensity with the Chronic Pain Grade Scale (CPGS), health-related quality of life with the SF-12, psychological distress with the Patient Health Questionnaire-4 (PHQ-4) and physical activity. Analysis of variance (ANOVA), multiple linear regression, and area under the curve (AUC) analysis were conducted. RESULTS: The mean age of the 294 participants was 53.5 (SD 8.7) years, and 38% were female. The ANOVA for disability and pain showed significant differences (p < 0.01) among the risk groups at 12 months. Post hoc Tukey tests revealed significant differences among all three risk groups for every comparison for both outcomes. AUC for STarT-G's ability to discriminate reference standard 'cases' for chronic pain status at 12 months was 0.79. A prognostic model including the STarT-Classification, the variables global health, and disability at baseline explained 45% of the variance in disability at 12 months. CONCLUSIONS: Disability differences in patients with back pain after a period of 12 months are in accordance with the subgroups determined using the STarT-G at baseline. Results should be confirmed in a study developed with the primary aim to investigate those differences.

[Evaluation of a Proactive Health Programme for Insured Persons with Persistent Back Pain: One-year Follow-up of a Randomised Controlled Trial]. / Evaluation eines proaktiv angebotenen Gesundheitsprogramms für Versicherte mit anhaltenden Rückenschmerzen ­ Ein-Jahres-Follow-up einer randomisierten, kontrollierten Studie.

BACKGROUND: To facilitate access to evidence-based care for persisting back pain, a private medical insurance developed a health programme and offered it proactively to their members. The aim of this study was to evaluate the feasibility and efficacy of this procedure. METHODS: The design of the study was a Zelen randomized controlled trial. Adult insured persons with persistent back pain were randomized to the control (CG) or intervention group (IG) prior to giving consent. The IG was invited to participate in the health programme, the CG in a survey. Primary outcomes were back pain intensity and disability (according to von Korff) and health-related quality of life (SF-12). At baseline, 12- and 24-month follow-up, outcomes were documented by identical online questionnaires. RESULTS: 552 of 3462 randomized insured persons agreed to participate in the study; 132 of 258 (51.2%) from the IG and 243 of 294 (82.7%) from the CG completed the questionnaires at the 12-month follow-up. Small beneficial effects were seen for 3 of 4 primary outcomes. Compared to the CG, the IG reported less severe pain intensity (38.6 vs 44.5; p=0.001; d=0.36) and less disability (1.6 vs 2.2; p=0.002; d=0.41). The IG scored better at the SF-12 physical health scale (43.6 vs 39.0; p<0.001; d=0.54); no beneficial effect was seen in the SF-12 mental health scale. CONCLUSIONS: The pro-active health programme seems to be feasible and effective as determined by patient-reported outcomes. Final evaluation awaits cost analysis and the results of the 24-month follow-up.

[On Clinical Significance in German Clinical Rehabilitation Trials - An Inventory of Current Practice]. / Zur Frage der klinischen Signifikanz in deutschen rehabilitationswissenschaftlichen Interventionsstudien ­ eine Bestandsaufnahme der gängigen Praxis.

OBJECTIVE: It is investigated whether and how the issue of clinical significance is treated in German rehabilitation trials. METHODS: Review of 64 articles published between 2012 and 2016, which report data on at least 2 measuring times and involve German scientists and rehabilitation facilities. RESULTS: Clinical significance is mentioned in 28% of the articles, defined by 19%, and 13% provide justification for the definition. Statistics suitable for determining clinical significance are reported by 70% but no more than 28% actually use these statistics for this purpose. The most commonly used statistics are measures of effect size (45%). They are interpreted schematically according to Cohen's categories without further reflection. CONCLUSION: Determining and discussing the clinical significance of results is recognizable in the majority of cases only to some extent or non-existing.

Validation of the "German Inflammatory Bowel Disease Activity Index (GIBDI)": An Instrument for Patient-Based Disease Activity Assessment in Crohn's Disease and Ulcerative Colitis.

INTRODUCTION: Assessment of disease activity in Crohn's disease (CD) and ulcerative colitis (UC) is usually based on the physician's evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDICD) and UC (GIBDIUC) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians' documented activity indices. METHODS: Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements. RESULTS: Rank correlations were 0.56 (pMS, GIBDIUC) and 0.57 (HBI, GIBDICD), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories). DISCUSSION: There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information.

Quality of care in inflammatory bowel disease: results of a prospective controlled cohort study in Germany (NETIBD).

BACKGROUND/AIMS: Patients with inflammatory bowel disease (IBD) need comprehensive, interdisciplinary and cross-sectoral health care. In Germany, evidence-based care pathways have been developed to improve the quality of care of IBD patients. We aimed to evaluate the effects of the implementation of some of these recommendations on patient-related outcomes. METHODS: In a region of North Germany, outpatients with IBD were recruited by gastroenterologists (intervention group). Three activities based on the recommendations of the IBD pathways were implemented, namely, 1) patient participation in a questionnaire-based assessment of 22 somatic and psychosocial problems combined with individualized care recommendations (patient activation procedure); 2) patient invitation to participate in a 2-day patient education program and 3) invitation to their gastroenterologists to participate in periodic interdisciplinary case conferences. For the control group, IBD patients receiving standard care at gastroenterology practices outside the specified region were recruited by their doctors. At baseline, 6- and 12-month follow-up, study patients were invited to complete questionnaires. Generic health-related quality of life, social participation and self-management skills were the main outcomes. RESULTS: At baseline, 349 patients were included in the study (intervention group: 189; control group: 160); 142 patients from the former and 140 from the latter group returned completed questionnaires at the 12-month follow-up. Over time, improvement in health-related quality of life and social participation was similar in both groups. Participants of the intervention group demonstrated improved self-management skills and more often followed steroid-free medication regimens. CONCLUSION: In a real-world clinical context, patient activation procedure combined with patient education and case conferences was less effective than expected. The observed beneficial effects, however, encourage the evaluation of more intensive and addressee-centered activities.

Medium-term effects of cardiac rehabilitation in Germany: systematic review and meta-analysis of results from national and international trials.

BACKGROUND: Contrary to international practice, cardiac rehabilitation (CR) in Germany is predominantly offered as comprehensive inpatient treatment lasting for 3 weeks. Evidence for this kind of health care is poor, comprising observational cohort studies only. METHODS: We conducted a systematic search for relevant German studies (1990-2004). International studies were selected from recent meta-analyses. Medium-term (12 month) results for blood lipids, blood pressure, functional capacity and psychological wellbeing, as well as cardiac morbidity and mortality are reported. RESULTS: For most outcomes, effect sizes in national studies are poorer than those from international interventions or, in the case of blood pressure and depression, even poorer than international controls. CONCLUSIONS: Altogether, our analysis does not suggest that comprehensive inpatient rehabilitation treatment is superior to international practice of long-term outpatient rehabilitation.

Is the occurrence of back pain in Germany decreasing? Two regional postal surveys a decade apart.

BACKGROUND: Back pain is often perceived as an epidemic disorder with an ever-increasing prevalence. The objective of this paper is to estimate and compare point and period prevalence rates of back pain from two highly comparable postal surveys, a decade apart within a single regional population in the north of Germany. METHODS: In 1991/1992 and 2003 two systematic random samples of German residents of Lübeck aged 25-74 years were independently drawn from the municipal population registry. They received a short postal questionnaire with maximally two reminders. All data were directly standardised on the age, sex, and educational distribution of the merged samples. A sharp decrease in response rates from 81% in the early 1990s to 60% in 2003 required complex considerations of non-response bias. RESULTS: Both the overall and gender-specific point and 1 year prevalence rates of back pain remained fairly stable as well as the rate of severe disabling back pain. The overall prevalence (adjusted for age, sex, and education) of 'back pain today' was 39.2% (1991/92) and 38.2% (2003), the 1 year prevalence was 75.3% (1991/92) and 73.8% (2003), and the prevalence of severe pain was 9.9% (1991/92) and 10.2% (2003). CONCLUSIONS: The data do not support the widespread public notion of a growing epidemic of back pain in Germany.

[Questions about questions: cognitive survey of questionnaire development]. / Fragen über Fragen: cognitive survey in der Fragebogenentwicklung.

OBJECTIVES: Traditional pretests are used in the development of survey items to identify technical and comprehension problems. Cognitive processes involved in answering survey questions are not the object of this kind of test. METHODS: Cognitive survey methods were used here to test a questionnaire screening for rehabilitation needs in people suffering from back pain. Essential techniques of cognitive testing (think-aloud, probing, confidence ratings) are outlined. We applied these techniques to 20 patients suffering from either acute or chronic back pain in order to test the survey. RESULTS: The main goal, i.e., identifying problems in item formulation by means of cognitive testing, was achieved. Almost one third of the survey questions were rephrased according to the results of the study. Some of the improvements of the questionnaire are illustrated. CONCLUSIONS: The increased effort required to perform cognitive testing as compared to traditional pretesting pays off. The two methods have specific pros and cons and cannot replace one another.