To facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this ...approach were evaluated.
Using Zelen's design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff's Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool).
Out of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline.
After 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it.
The trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).
The aeroacoustic mechanisms in human voice production are complex coupled processes that are still not fully understood. In this article, a hybrid numerical approach to analyzing sound generation in ...human voice production is presented. First, the fluid flow problem is solved using a parallel finite-volume computational fluid dynamics (CFD) solver on a fine computational mesh covering the larynx. The CFD simulations are run for four geometrical configurations: both with and without false vocal folds, and with fixed convergent or convergent–divergent motion of the medial vocal fold surface. Then the aeroacoustic sources and propagation of sound waves are calculated using Lighthill’s analogy or acoustic perturbation equations on a coarse mesh covering the larynx, vocal tract, and radiation region near the mouth. Aeroacoustic sound sources are investigated in the time and frequency domains to determine their precise origin and correlation with the flow field. The problem of acoustic wave propagation from the larynx and vocal tract into the free field is solved using the finite-element method. Two different vocal-tract shapes are considered and modeled according to MRI vocal-tract data of the vowels /i/ and /u/. The spectra of the radiated sound evaluated from acoustic simulations show good agreement with formant frequencies known from human subjects.
Many CED-patients struggle with complex problem profiles and may be offered and profit from multidisciplinary multimodal rehabilitation. It is still unclear by whom and with what effects this option ...is used.
We compared the results of an observational cohort study of 199 CED-inpatients of a single rehab clinic with those of 310 gastroenterological outpatients using propensity score matching.
Rehabilitands show more complex problem profiles than CED-outpatients. After 6 months of follow up direct and indirect change measures show generally small positive changes - however comparable in quality and size with that of matched outpatients.
Complex rehab is mainly used by CED-patients with several bio-psycho-social problems. Our preliminary data do not suggest a marked additional benefit of inpatient rehab compared to specialised outpatient care. Stricter controlled trials are urgently needed.
Abstract
Background
IBD nurses play an important role in the Multidisciplinary Team of managing patients with IBD. IBDBIO-ASSIST was a randomised controlled trial assessing the efficacy of care ...provided by an IBD nurse specialist in improving health-related quality of life (QoL) in IBD patients on biologic therapy in an outpatient setting in Germany.
Methods
In total, 1086 IBD patients on biologic therapy were randomly assigned to either a control group (CG) receiving usual IBD care or an intervention group (IG) receiving additional care from an IBD nurse. Two IBD nurses per site received an extra study specific IBD training before including patients. The primary outcome was disease-specific QoL (sIBDQ) assessed at months (M) 6, 12, and 18. In addition, IBD nurses provided a final assessment of various aspects of their work in the context of the study at M6 (T0) and M15 (T1), and patients were asked about their satisfaction level with the IBD nurses.
Results
The analysis of patients with impaired QoL at baseline (EQ-VAS < 75 median), showed an improvement in sIBDQ over 6 M that became significant at M12 and remained significant through M18 (baseline: IG 4.24; CG 4.31; M18: IG 5.02; CG 4.76; P= .017) (Table 1). Regarding the 5 aspects of fun, usefulness, successful discussions in consultations with patients, successful support of patients, and appreciation by patients, the nurses expressed positive assessments (“completely” and “rather”) at both measurement points, with values of more than 90% (Fig. 1). About 20% to 30% of the nurses reported being rather dissatisfied with two aspects of their jobs: time and space resources for discussions and recognition by physicians. 94% of patients in the IG felt that the additional care provided by the IBD nurses was highly beneficial.
Conclusion
IBD patients with impaired QoL derived a significant benefit from the additional care provided by an IBD nurse specialist, leading to meaningful improvements in sIBDQ over the long term. The survey results from the IBD nurses and patients in the IG revealed a very positive perception of the new form of care. It is noteworthy that an improvement in care provision was reported both by the nurses and the participating patients. Some physicians also experienced benefits from the intervention as they were relieved of certain time-consuming tasks by the IBD nurses. It should be noted that more than 20% of the IBD nurses did not feel sufficiently appreciated by physicians, and about 30% criticised the lack of time and space resources. When introducing the IBD nurse-led care concept into usual practice, these aspects should be considered.
Hypersensitivity pneumonitis is characterized by pulmonary accumulation of B-cell-rich tertiary lymphoid tissues (TLTs), which are alleged sites of amplification for antigen-specific responses. The ...sphingosine-1-phosphate receptor 1 (S1P
) regulates key mechanisms underlying lymphoid tissue biology and its chemical modulation causes lymphocyte retention in lymph nodes. Given the putative immunopathogenic impact of lymphocyte accumulation in TLTs, we investigated whether or not chemical modulation of S1P
caused lymphocyte retention within TLTs in a model of hypersensitivity pneumonitis. Mice were exposed subchronically to Methanosphaera stadtmanae (MSS) in order to induce an hypersensitivity pneumonitis-like disease. MSS exposure induced B-cell-rich TLTs surrounded by S1P
-positive microvessels. Upon MSS rechallenge, the S1P
agonist RP001 prevented the pulmonary increase of CXCL13, a chief regulator of B-cell recruitment in lymphoid tissues. This was associated with a complete inhibition of MSS rechallenge-induced TLT enlargement and with a 2.3-fold reduction of MSS-specific antibody titers in the lung. Interference with TLT reactivation was associated with a 77% reduction of neutrophil accumulation and with full inhibition of protein-rich leakage in the airways. Thus, an S1P
agonist hinders TLT enlargement upon antigenic rechallenge and inhibits key pathognomonic features of experimental hypersensitivity pneumonitis.
In recent years the prevalence of psychosomatic illnesses increased considerably, therefore the relevance of medical rehabilitation is also increasing. The effectiveness of psychosomatic medical ...rehabilitation has been demonstrated, but only a small proportion of rehabilita-tion patients manage to transfer the rehabilita-tion success into the daily routine. Numerous -aftercare offers should stabilize the effects of -rehabilitation. Against this background, a new -rehabilitation aftercare strategy ("New Credo"), initially developed and evaluated with good -results for orthopedic indications, was tested for psychosomatic indications. The aim of the present study was to test the concept in a psychosomatic rehabilitation clinic in terms of feasibility (feasibility-study). Further an evaluation of the results of the new credo can be made by the use of a "historical" control group.
In a longitudinal feasibility study with 3 points of measurement (before and after rehab as well as after 4 months) the feasibility and acceptance of the new credo was examined. One psychosomatic rehabilitation clinic in Schleswig-Holstein participated in the study, included were rehabilitation patients with depressive disorders (F32.x, F33.x und F40; ICD-10). The new credo philosophy was implemented in the clinical routine as well as the supporting materials were -applied during the project duration. During the study period the clinic was provided with a person in charge for the aftercare program. Psychological symptom severity (BSI) was defined as primary outcome variable. Secondary outcome variables were the subjective health, restriction in participation as well as health-related quality of life. Complete data were available for 91 rehabilitation patients. They were compared with matched data in terms of age, gender and school education from the "Qualitätsgemeinschaft medizinische Rehabilitation in Schleswig-Holstein".
The new credo is also in psychosomatic rehabilitation well-accepted by all persons involved. The rehabilitation pa-tients used their rehabilitation stay to find a suitable activity for themselves for the time after rehabilitation. The majority evaluated the keeping of the diary as positive. In the primary and secondary outcome variables are medium to big effects visible in regard of short- to fairly long-term improvements. In the comparison with the "historical" control group on the level of intra-group effects remains an advantage in favor of the new credo.
The new credo proved to be also feasible for rehabilitation patients with depressive disorders, the rehabilitation- and aftercare strategy was well-accepted by the clinic and the rehabilitants. Most of the rehabilitation patients evaluated the new rehabilitation philosophy and the accompanied aftercare positively. First promising results indicate an increased sustainability of rehabilitation success using the new credo. Their validation in a multicenter controlled study design remain to be seen.
Chronic and prognostically doubtful diseases like inflammatory bowel diseases (IBD) often lead to reduced work ability. Whether self-management-interventions have positive effects on work related ...outcomes is so far unclear.
Data from a randomized controlled trial of adult members of a German statutory health insurance with medically confirmed IBD were reanalyzed. We focused on 337 gainfully employed study participants. They completed a screening questionnaire enquiring about 22 disease-related bio-psycho-social problems. The intervention group (IG) received individualized (problem-adapted) written recommendations; the control group remained under usual care. 12 months later a follow-up questionnaire was employed, data on sick leave were made available by the health insurance.
The IG showed beneficial effects in all primary outcomes (EuroQol visual analog scale score, index for measuring participation restriction and number of self-reported disability days). At baseline one in four of the employed participants reported a negative subjective prognosis of their work capacity (assessed by means of a 3-item Likert scale, SPE scale). No positive intervention effects on work-related outcomes (subjective prognosis of gainful employment, episodes and days of sick leave) could be detected.
In IBD patients work and earning capacity is often at risk and should be regularly assessed. Effective interventions to protect or restore gainful employment are needed. Medical-vocational rehabilitation could be a treatment option; its efficacy and benefit (in IBD) are still to be demonstrated.
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.
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.
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.
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.
In recent years, rehabilitation aftercare has become an important topic in rehabilitation research and practice. This development was initiated by the lack of long-term effects after rehabilitation ...treatment and by the deficits identified in several reviews of aftercare recommendations and of actual practice of aftercare. Against this background, a new aftercare strategy was developed, the "New Credo", which focused aftercare from the beginning of rehabilitation treatment. A substantial element of the concept is the resumption and maintenance of physical activity in everyday life of the rehabilitation patient. The goal of the present study was the evaluation of this concept in a sample of patients with chronic back pain.
The "New Credo" was evaluated in a multi-centre, prospective controlled longitudinal study with 3 points of measurement (before and after rehab as well as after 12 months). 6 rehabilitation clinics in Schleswig-Holstein were included in the intervention arm (IG, 3 clinics) and in the control arm (CG, 3 clinics), participants were rehabilitants with chronic back pain. The clinics in the intervention arm implemented "the New Credo" in accordance with their local conditions. During the study period they were provided with a person who was responsible for managing aftercare activities for patients. Participants in the CG received standard rehabilitation treatment according to general guidelines. Restriction of social participation, disability days and restriction in functional capacity in everyday life were defined as primary outcomes. Complete data were available for 166 rehabilitants in the IG and 368 in the CG.
At the end of rehabilitation rehabilitants in the IG reported significantly higher use of treatment offerings and more intensive preparation for the time after rehabilitation treatment than rehabilitants in the CG. Rehabilitants in the IG found recommendations for the time after treatment significantly better than those in the CG. As expected, both rehabilitants in the IG and in the CG showed similar outcomes directly after inpatient treatment. With respect to long-term effects 12 months later, significant differences with moderate effect sizes were observed in 2 of the 3 primary outcomes (function capacity and social participation) in favour of the IG. With respect to secondary outcomes, rehabilitants in the IG showed significantly better long-term results than those in the CG.
Our results show that the "New Credo" can successfully be implemented into rehabilitation practice. The "New Credo" was positively rated by clinicians and rehabilitants. Rehabilitants in the IG found offerings of supported aftercare very helpful. The intensity of actual use of aftercare by rehabilitants as well as the emphasis laid on aftercare by clinicians indicate that treatment was focused on aftercare over the whole time of rehabilitation and that the rehabilitants transferred these aspects into everyday life. For the rehabilitants in the IG higher long-term effects could be observed compared to those in the CG. This suggests an improved sustainability of rehabilitation effects and a successful transfer of acquired knowledge and self-efficacy in everyday life.
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.
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