[How effective are non-pharmacological interventions for family caregivers? A systematic review with meta-analyses]. / Wie wirksam sind nicht-pharmakologische Interventionen für pflegende Angehörige? Ein systematisches Review mit Metaanalysen.

INTRODUCTION: Informal caregiving is associated with mental disorders and reduced quality of life. The aim of this systematic review was to summarize the results of methodologically high-quality intervention studies on the effectiveness of non-pharmacological interventions on patient-relevant outcomes for family caregivers in Germany. METHOD: We searched three large scientific literature databases for intervention studies with a control group and a low or moderate risk of bias on the effectiveness of non-pharmacological interventions for family caregivers in Germany. RESULT: Among 4,376 publications reviewed, 10 intervention studies with good methodological quality were identified. These investigated multi-component interventions or cognitive behavioral therapy for family caregivers of people with dementia (8 studies), stroke (1 study) and with general care dependency (1 study). The control groups received information material as a minimal intervention or usual standard care. Meta-analyses showed a statistically significant slight reduction in depressive symptoms 3-6 months after the start of the study as a result of cognitive behavioral therapy (standardized mean difference -0.27; 95% confidence interval -0.44 - -0.10), but this no longer reached statistical significance after 9-12 months (-0.21; -0.51 - 0.09). Multi-component interventions showed no changes in depressive symptoms either after 3-6 or after 9-12 months (-0.18; -0.40 - 0.03 and -0.14; -0.47 - 0.14, respectively). In contrast, the mental component of quality of life of family caregivers improved statistically significantly in the multi-component intervention groups compared to the control groups: slightly after 3-6 months (0.28; 0.01 - 0.56) and moderately after 9-12 months (0.45; 0.09 - 0.82). The interventions had no effect on the physical component of quality of life. CONCLUSION: The reduction of depressive symptoms by behavioral therapy interventions for family caregivers appears to be only slight and not sustainable. The mental component of quality of life of people affected may be improved in the longer term by multi-component interventions. Current scientifically examined interventions for informal caregivers do not appear to have a sufficient and sustainable effect. Greater effects could possibly be achieved through more elaborate behavioral approaches, but also structural preventive measures.

Effects of occupational health promotion interventions on health-related outcomes among employees of small businesses and self-employed individuals: A systematic review.

BACKGROUND: Compared to workers of larger companies it is less clear what health promoting interventions might be beneficial for employees of small businesses and self-employed individuals. OBJECTIVE: Our aim was to critically appraise trials investigating health promotion programs among small business workers and self-employed individuals, by means of a systematic review. METHODS: We conducted a search of primary studies using MEDLINE, Web of Science, LIVIVO and the Cochrane library. Our assessment followed the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and PRISMA. RESULTS: We identified six trials including 5,854 participants from Asia, North America and Australia. Most were of moderate methodological quality, only one was of low quality. Some of the supervised psycho-educational lifestyle programs focusing on individual behavior changes showed benefits in terms of stress reduction and increased physical activity levels among small enterprise employees. CONCLUSIONS: There is a huge knowledge gap on evidence-based health promotion interventions for self-employed and for small business workers, especially in Europe.

Investigation of long-term pressure on primary packaging materials and a biologic drug product for injection with a novel autoinjector concept.

Gerresheimer and Midas Pharma have developed a novel cartridge-based autoinjector concept in which the cartridge as primary packaging is under constant pressure. In this article standard cartridge primary packaging material of five different companies were analyzed for their behavior under long-term pressure. Materials of 3 glass manufacturers and 2 manufacturers for cartridge rubber parts were considered. Within the test program septum stability, septum piercing, glide forces (GF), break-loose forces (BLF), glass breaking as well as a regulatory approved and marketed antibody drug product under pressure were subject to analysis. Under pressure the cartridge septum bulge grew within the first 14 days and then relevantly slowed down. An accelerated study in different atmospheric conditions allowed to extrapolate values for 24 months storage, not showing any signs of decay or problematic septum bulge increase. Pierce forces were in normal ranges and septum rupture could not be observed at the end of 42 days of pressurization. GF and BLF were within acceptable ranges and changes due to pressure could not be observed. Lowest glass breaking pressures at 4922 kPa turned out to be at least 3.5 times higher than pressures used in the autoinjector concept. Degradation of the Adalimumab antibody drug product due to pressure or device fluid pathway could not be observed with size exclusion chromatography, electrophoresis or sub-visible particles tested as a release testing in a GMP setting.