[Effects of a One-Week Inpatient Health Programme for Family Caregivers and Persons in Need of Care (SVLFG Care Tandem) - A Quasi-Experimental Study]. / Effekte eines einwöchig-stationären Gesundheitsprogramms für pflegende Angehörige gemeinsam mit ihrer pflegebedürftigen Person (Pflege-Tandem der SVLFG) ­ eine quasiexperimentelle Studie.

AIM: The aim of this study was to assess the effect of a one-week inpatient health programme for family carers together with the persons in need of care (care tandem) on the well-being of family carers. Acceptance and subjective benefits were also assessed. The intervention was funded by the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG). METHODOLOGY: Central to the intervention are (1) the home care counselling before the seminar, (2) the one-week seminar in the setting of a rehabilitation clinic at a health resort, in particular with a care course, exercise and relaxation units and the use of local remedies, (3) the substitute care of the person in need of care in close proximity to the seminar location and (4) the low-threshold telephone aftercare by SVLFG specialists. In a controlled prospective panel study (IG n=35, VG n=67, allocation not randomised), well-being (WHO-5, range 0-100) was measured at several points in time (IG: 0, 1, 9, 17, 28 and 43 weeks after the start of the seminar; VG 0, 17, 28 and 43 weeks). Statistical analyses were performed using fixed-effects panel regression, controlling for time-varying covariates (period effects, external stress). RESULTS: In the IG (80% women, mean age 66.5 years), 69% of family carers showed evidence of clinically relevant depression at baseline. All care levels were represented among the people in need of care, predominantly 2 and 3, with medically diagnosed dementia in 37% of the cases. The VG was similarly structured. Under the condition of stable external stress, the initial effect was very clear (delta=+19 points). The effect then flattened out, but remained fairly stable at around 10 points above the initial level. Although the last measurement (43 weeks) was no longer statistically significantly higher, it was independent of the development of external stress. Acceptance and subjective benefit were very high. CONCLUSIONS: The strength of the intervention is the dyadic approach. The intervention promotes well-being and is highly accepted. The design allows at least cautious causal conclusions. For the remaining limitations, larger case numbers and a randomised controlled trial would be necessary.

[Risk-Adjustment of Return to Work After Medical Rehabilitation: Methodical Advancements in Quality Assurance of the German Pension Insurance]. / Adjustierung des sozialmedizinischen Verlaufs nach medizinischer Rehabilitation: methodische Weiterentwicklung der Reha-Qualitätssicherung der Deutschen Rentenversicherung.

PURPOSE: Besides the quality of life, patients' return to work is one of the most important treatment results of medical rehabilitation paid by the German Pension Insurance. In order to be able to use the return to work as a quality indicator for medical rehabilitation, a risk adjustment strategy for pre-existing characteristics of patients, rehabilitation departments and labour markets had to be developed. METHODS: Multiple regression analyses and cross validation were used to develop a risk adjustment strategy, which mathematically compensates the influence of confounders and thus allows for appropriate comparisons between rehabilitation departments regarding patients' return to work after medical rehabilitation. Under the inclusion of experts, the number of employment days in the first and second year after medical rehabilitation were chosen as an appropriate operationalization of return to work. Methodological challenges in the development of the risk adjustment strategy were the identification of a suitable regression method for the distribution of the dependent variable, modelling the multilevel structure of the data appropriately and selecting relevant confounders for return to work. A user-friendly way of communicating the results was developed. RESULTS: The fractional logit regression was chosen as an appropriate regression method to model the U-shaped distribution of the employment days. Low intraclass correlations indicate that the multilevel structure of the data (cross-classified labour market regions and rehabilitation departments) is statistically negligible. Potential confounding factors were theoretically preselected (medical experts were involved for medical parameters) and tested for their prognostic relevance in each indication area using backwards selection. Cross validations proved the risk adjustment strategy to be stable. Adjustment results were displayed in a user-friendly report, including the users' perspective (focus groups and interviews). CONCLUSIONS: The developed risk adjustment strategy allows for adequate comparisons between rehabilitation departments and thus enables a quality assessment of treatment results. Methodological challenges, decisions and limitations are discussed in details throughout this paper.

[More free time for me? Effects of a group intervention for informal caregivers based on routine data from the SVLFG long-term care insurance]. / Mehr Freiraum für mich? Effekte einer Gruppenintervention für pflegende Angehörige anhand von Routinedaten der SVLFG-Pflegekasse.

BACKGROUND: The intervention is a multiday health program of the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) for informal caregivers. AIM OF THE WORK: Does the intervention increase the use of outside help to gain free time for self-care? MATERIAL AND METHODS: Using a quasi-experimental within-design, we analyze annual benefit data from the SVLFG long-term care insurance for the cluster sample Bavaria from 2017 to 2020 with intervention in 2018/2019. Using fixed effects panel regressions, we determine the effect heterogeneity for care relationship, duration of care and degree of care, adjusting for period effects (intervention and comparison group: 88 and 6045 persons with 207 and 16,091 observations, respectively). RESULT: After the intervention, the use of services for outside help tends to be higher than before. The effect is significantly more pronounced with increasing care level, care within the partnership and shorter care duration. With care within the partnership, start of care before 1 year and care level 4/5, more outside help is used afterwards for 1160 € (p < 0.001) than before. DISCUSSION: Design and statistical method would allow a causal conclusion; however, in view of the limitations, in particular the small number of cases in the intervention group and the only limited characteristics available to control for time-dynamic heterogeneity, caution is advisable.

Do patient characteristics affect the predictive validity of Functional Capacity Evaluations?

PURPOSE: The aim of this study was to identify patient-related characteristics that affect the predictive validity of the FCE assessment ELA. METHODS: A prospective multicenter study was conducted on 303 patients with musculoskeletal disorders (MSD) recruited from eleven rehabilitation centers. The ELA-based estimation of the participants' ability to cope with physical work demands was considered valid if RTW was paired with a positive ELA outcome (≥ moderate) as well as if non-RTW was accompanied by a negative ELA outcome (rather or very poor). In the remaining cases, the ELA result was judged as non-valid. To reduce the risk of false conclusions, the rating was performed inversely in participants that (1) reported severe limitations regarding their productivity at work, (2) attributed RTW to a change in job resp. a reduction of their physical work demands and in those that (3) attributed non-RTW to non-physical reintegration barriers only. Using questionnaires, 28 patient-related characteristics were collected. Logistic regression models were calculated to identify characteristics that affected the predictive validity of ELA. RESULTS: ELA was considered valid in 208 of 303 (69%) participants. A moderate and strong pain-related disability at work were associated with a 0.15-fold (95% confidence interval (95% CI) 0.05-0.46), respectively, 0.19-fold (95% CI 0.05-0.72) chance for a valid outcome. In addition, a negative influence was found in participants that reported psychosocial distress (odds ratio (OR) 0.35; 95% CI 0.15-0.82), a native language different from the national language (OR 0.16; 95% CI 0.05-0.56) as well as in those that expected to return to work, but not within one month (OR 0.17; 95% CI 0.06-0.46). Further variables-including age, employment status, fear-avoidance beliefs and the level of physical work demands-did not affect the predictive validity of ELA. CONCLUSIONS: The results suggest that the predictive validity of ELA is primarily limited by patients that report a moderate or strong pain-related disability at work, psychosocial distress as well as the expectation to return to work, but not within one month. Furthermore, a negative influence can be assumed for language barriers.

Matching Perceived Physical Capacity and Work Demands: A New Classification of the Modified Spinal Function Sort (M-SFS).

Purpose The aims of this study were (1) to develop a new classification for the scores of the Modified Spinal Function Sort (M-SFS) which is related to the level of physical work demands and (2) to test the predictive value of the M-SFS classification. Methods The classification was carried out in 194 subjects with musculoskeletal disorders (MSD) attending a work-related medical rehabilitation from four rehabilitation centers. External criterion was a Functional Capacity Evaluation (FCE)-based work capacity estimation according to the classification used in Germany ("REFA") which differentiates between light, light to medium, medium and heavy work. The optimal cut-offs for the M-SFS were allocated using the Youden index. Logistic regression models were calculated based on 147 subjects who participated in the follow-up survey to evaluate the predictive validity of the M-SFS classification with regard to sustainable return to work (RTW; employment at the 3-month follow-up combined with a low level of sick leave). Results Cut-offs for M-SFS scores were 44 (light work), 54 (light to medium work), 62 (medium work) and 73 (heavy work). A match between the M-SFS category and the level of physical work demands was associated with a more than threefold higher RTW chance compared to subjects with a negative discrepancy. In case the M-SFS category was above the physical demand level the RTW-chance was more than 13-fold higher. Conclusions M-SFS scores can be classified into four levels of physical work demands. If the perceived work capacity matches or exceeds the level of physical work demands patients with MSD have a substantially higher probability to return to work after rehabilitation. More studies are needed to confirm or reject our findings and overcome some of the weaknesses of this study.

[Effect of a One-Week Health Program on the Mental Health of Caregiving Parents: A Controlled Panel Study]. / Effekt eines einwöchigen Gesundheitsprogramms auf die psychische Gesundheit von pflegenden Eltern ­ eine kontrollierte Panelstudie.

OBJECTIVES: Parents of children in need of care and home care are a vulnerable group. The aim of this study was to determine the effect of a legally funded, one-week health program of the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) on the well-being of the participating caregiving. Methods In a controlled panel study (intervention group IG n=23, comparison group n=33, allocation not randomized), the WHO-5 index was collected at several time points of measurement. Evaluation was performed by fixed effects panel regression under control of time-varying characteristics (external conditions, period effects). RESULTS: At the start of the intervention, 70% of the IG were at the threshold of clinically relevant depressiveness. After a very clear initial effect, the level remained above the baseline level for up to 15 weeks (under stable conditions). However, a sinking below the initial level was prevented until at least 26 weeks even with significantly increasing stress. CONCLUSION: Considering the high initial burden, the effect of the prevention-oriented intervention is persistent over a considerable period of time. The intervention is unique for the social insurance system. The design allows a causal interpretation despite the small number of cases.

Predictive validity of a customized functional capacity evaluation in patients with musculoskeletal disorders.

PURPOSE: To examine whether the performance-based work-related functional capacity evaluation (German title: Einschätzung körperlicher Leistungsfähigkeiten bei arbeitsbezogenen Aktivitäten-ELA) can predict return to work (RTW) in patients with musculoskeletal disorders (MSD). METHODS: A multicenter cohort study was conducted on 162 employed or self-employed patients with various injury-related and chronic MSD, recruited from four outpatient rehabilitation clinics. Patient-reported data on health and work ability were collected at discharge. The FCE test was performed subsequently. The overall FCE-based estimation of the ability to cope with the physical demands of work (positive vs. negative) was used to predict RTW. Successful RTW was defined as a combination of (self-)employment at the 3-month follow-up and a low level of sick leave (< 1.5 weeks) due to MSD. Odds ratios (OR) and 95% confidence intervals (CIs) were calculated using logistic regression models to evaluate the predictive validity of the adjusted FCE results. RESULTS: Based on the FCE test, 82% of the patients were estimated as being able to cope with the physical demands of work. 77% of the patients with a positive FCE outcome returned to work (positive predictive value) and 83% with a negative FCE outcome did not (negative predictive value). Patients whose functional capacity was estimated to match the job demands were associated with sixfold higher odds of returning to work after adjusting for patient-reported data on health and work ability. The agreement between the FCE result and RTW differed only on a low to moderate level between the therapists who administered the FCE (72-89%). CONCLUSION: The FCE test at discharge predicts RTW among patients with musculoskeletal disorders.

[The Return to Work Status One Year After Vocational Retraining: Is it an Indicator for Long Term Occupational Participation?] / Was sagt das Return to Work ein Jahr nach Ende einer beruflichen Bildungsleistung über die längerfristige berufliche Teilhabe aus?

BACKGROUND AND OBJECTIVE: Vocational retrainings (VR) in the context of vocational rehabilitation are lengthy and expansive interventions. The question is whether the return to work (RTW) 12 months after VR can be a proxy variable for long term income trajectories. METHODS: Based on register data of the German Pension Insurance (Scientific Use File SUFRSDLV09B) fixed-effects-regressions were calculated to measure the effect of VR on the annual mean daily income in each of the 3 years after VR compared to initial level prior to VR and depending on the RTW. RESULTS: The mean difference for the daily income was about -20 € per day. For persons being employed prior to the VR a loss of income up to 50 € per day was measured. Persons being unemployed prior to the VR increased their daily income up to 30 €. Moderate to large effects of the RTW could be measured (d=0.52 to 1.33). CONCLUSION: The RTW 12 months after VR seems to be a good representation for long term income trajectories. Therefore, it can be recommended as an indicator for outcome quality of VR.

[The Prognostic Validity of the Functional Capacity Evaluation ELA in Work-Related Medical Rehabilitation]. / Die prognostische Validität des FCE-Verfahrens ELA in beruflich orientierten medizinischen Rehabilitationsmaßnahmen.

The aim of the study was to determine the ability of FCE (Functional Capacity Evaluation) to predict sustained return-to-work (RTW). A multicentric prospective cohort study was conducted in cooperation with 4 outpatient rehabilitation clinics. The sample consisted of 198 patients. Sustained RTW was defined as a combination of employment at 3-month follow-up with a low level of sick leave (dependent variable 1) resp. with a moderate or better rating of the current work ability with respect to the physical demands at work (dependent variable 2). Based on questionnaires and FCE information, logistic regression models were calculated to predict sustained RTW. The FCE-information at discharge predicted sustained RTW after adjusting for assessors (Odds Ratio - OR=17.2 [95% CI: 6.2-57.8] resp. OR 12.8 [95% CI: 5.1-32.1]) as well as after adjusting for additional RTW predictors (OR 14.6 [95% CI: 4.8-44.9] resp. OR 10.1 [95% CI: 3.5-29.4]). Concerning dependent variable 1 and the FCE-information at admission there was a gain of information towards a model based on patient self-reports (OR 2.6 [95% CI: 1.1-6.0]). The study supports the predictive validity of crude and adjusted FCE-information. The gain of information towards patient self-reports is unclear.

Promoting Return to Work After Vocational Rehabilitation Using a Work-Related Fitness App: Protocol for a Cluster-Randomized Controlled Trial.

BACKGROUND: Retraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity. OBJECTIVE: The aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes). METHODS: We conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes. RESULTS: This study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022). CONCLUSIONS: The findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50200.

Return to work after medical rehabilitation in Germany: influence of individual factors and regional labour market based on administrative data.

Background: The influence of both individual factors and, in particular, the regional labour market on the return to work after medical rehabilitation is to be analyzed based on comprehensive administrative data from the German Pension Insurance and Employment Agencies. Method: For rehabilitation in 2016, pre- and post-rehabilitation employment was determined from German Pension Insurance data for 305,980 patients in 589 orthopaedic rehabilitation departments and 117,386 patients in 202 psychosomatic rehabilitation departments. Labour market data was linked to the district of residence and categorized into 257 labour market regions. RTW was operationalized as the number of employment days in the calendar year after medical rehabilitation. Predictors are individual data (socio-demographics, rehabilitation biography, employment biography) and contextual data (regional unemployment rate, rehabilitation department level: percentage of patients employed before). The estimation method used was fractional logit regression in a cross-classified multilevel model. Results: The effect of the regional unemployment rate on RTW is significant yet small. It is even smaller (orthopaedics) or not significant (psychosomatics) when individual employment biographies (i.e., pre-rehabilitation employment status) are inserted into the model as the most important predictors. The interaction with pre-rehabilitation employment status is not substantial. Conclusions: Database and methods are of high quality, however due to the nonexperimental design, omitted variables could lead to bias and limit causal interpretation. The influence of the labour market on RTW is small and proxied to a large extent by individual employment biographies. However, if no (valid) employment biographies are available, the labour market should be included in RTW analyses. Supplementary Information: The online version contains supplementary material available at 10.1186/s12651-023-00330-1.

Eukaryotic expression and secretion of EGFP-labeled annexin A5.

The Ca2+-dependent binding of annexin A5 to phosphatidylserine on cell surfaces is a reliable marker for apoptosis that is widely used in flow cytometry based apoptosis assays. In this approach, annexin A5 must be coupled to a fluorescent dye, but standard dyes such as fluorescein are photolabile, and the heterogeneous chemical linkage partially inhibits binding to phosphatidylserine. Recombinant fusions comprising annexin A5 and fluorescent proteins are available for prokaryotic expression, but can be purified only at low concentrations due to their low solubility in the cytoplasm. Here we describe a eukaryotic expression system for the secretion of functional recombinant annexin A5, with and without fluorescent protein fusions, in different formats. Metal affinity purification yielded up to 18 microg of histidine-tagged annexin A5 fusions per ml processed cell culture supernatants. Furthermore the supernatant itself was sufficient for direct use in apoptosis assays. The availability of such fusion proteins offers new and more economical opportunities for the development and application of this widely utilized apoptosis assay.

Small cleavable adapters enhance the specific cytotoxicity of a humanized immunotoxin directed against CD64-positive cells.

The most potent immunotoxins (ITs) developed to date contain bacterial or plant cytotoxic components. As these are potentially immunogenic in man, human proteins are preferred for the long-term treatment of cancer. We have developed the first humanized IT for the treatment of CD64 malignancies such as acute myeloid leukemia. The bacterially expressed IT is composed of a humanized anti-CD64 single chain fragment [h22(scFv)] genetically fused to the human RNase angiogenin. As angiogenin lacks a dedicated translocation domain responsible for the higher potency of bacterial and plant-derived toxins, we have incorporated a recombinant adapter that contains a synthetic translocation domain flanked by proteolytically cleavable endosomal and cytosolic consensus sites. Although insertion of the adapter increased the cytotoxicity by up to 20-fold, serum stability was markedly reduced. Therefore, we designed a modified adapter variant with the endosomal-cleavable peptide deleted. The IT containing the truncated adapter showed significantly higher cytotoxicity than the adapter-free IT and superior serum stability to facilitate the potential applications in patients.