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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.
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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.
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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.
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BACKGROUND: A stringent systematic review of population-based observational studies focusing on the physical health of self-employed individuals as a basis for the development of targeted prevention strategies is lacking. OBJECTIVE: We aimed to systematically evaluate all the studies of good quality that compared the occurrence of chronic physical disorders in self-employed individuals with that of employees. METHODS: We searched three major medical databases (MEDLINE, Web of Science, Embase) following the Cochrane guidelines. The quality of the studies was rated based on the slightly modified validated assessment tool that was developed by Hoy et al.RESULTS:We included 16 population-based studies of good quality, with data from 15,369,964 participants in total. The two longitudinal evaluations of Swedish national registers with the longest follow-up periods showed increased cardiovascular mortality and incidence estimates of cardiovascular disease in self-employed individuals compared with those of white-collar (i.e., nonmanual) employees but decreased risk estimates compared with those of blue-collar (i.e., manual) workers. The results of the shorter cohort studies were heterogeneous. In cross-sectional studies, prevalence estimates for musculoskeletal, respiratory and malignant diseases were higher among self-employed individuals than among employees. CONCLUSION: The long-term cardiovascular disease risk and mortality of self-employed individuals seemed to be higher than those of white-collar employees but lower than those of blue-collar employees. As a basis for targeted prevention strategies, further longitudinal studies in different settings are required to better understand the development of physical health disorders for specific self-employment categories such as sole proprietors, small entrepreneurs, family businesses and others.
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Enfermedades Cardiovasculares , Humanos , Estudios Transversales , Empleo , Examen Físico , Estudios de CohortesRESUMEN
A systematic overview of mental and physical disorders of informal caregivers based on population-based studies with good methodological quality is lacking. Therefore, our aim was to systematically summarize mortality, incidence, and prevalence estimates of chronic diseases in informal caregivers compared to non-caregivers. Following PRISMA recommendations, we searched major healthcare databases (CINAHL, MEDLINE and Web of Science) systematically for relevant studies published in the last 10 years (without language restrictions) (PROSPERO registration number: CRD42020200314). We included only observational cross-sectional and cohort studies with low risk of bias (risk scores 0-2 out of max 8) that reported the prevalence, incidence, odds ratio (OR), hazard ratio (HR), mean- or sum-scores for health-related outcomes in informal caregivers and non-caregivers. For a thorough methodological quality assessment, we used a validated checklist. The synthesis of the results was conducted by grouping outcomes. We included 22 studies, which came predominately from the USA and Europe. Informal caregivers had a significantly lower mortality than non-caregivers. Regarding chronic morbidity outcomes, the results from a large longitudinal German health-insurance evaluation showed increased and statistically significant incidences of severe stress, adjustment disorders, depression, diseases of the spine and pain conditions among informal caregivers compared to non-caregivers. In cross-sectional evaluations, informal caregiving seemed to be associated with a higher occurrence of depression and of anxiety (ranging from 4 to 51% and 2 to 38%, respectively), pain, hypertension, diabetes and reduced quality of life. Results from our systematic review suggest that informal caregiving may be associated with several mental and physical disorders. However, these results need to be interpreted with caution, as the cross-sectional studies cannot determine temporal relationships. The lower mortality rates compared to non-caregivers may be due to a healthy-carer bias in longitudinal observational studies; however, these and other potential benefits of informal caregiving deserve further attention by researchers.
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Cuidadores , Calidad de Vida , Estudios Transversales , Humanos , Dolor , PrevalenciaRESUMEN
We aimed to systematically identify and evaluate all studies of good quality that compared the occurrence of mental disorders in the self-employed versus employees. Adhering to the Cochrane guidelines, we conducted a systematic review and searched three major medical databases (MEDLINE, Web of Science, Embase), complemented by hand search. We included 26 (three longitudinal and 23 cross-sectional) population-based studies of good quality (using a validated quality assessment tool), with data from 3,128,877 participants in total. The longest of these studies, a Swedish national register evaluation with 25 years follow-up, showed a higher incidence of mental illness among the self-employed compared to white-collar workers, but a lower incidence compared to blue-collar workers. In the second longitudinal study from Sweden the self-employed had a lower incidence of mental illness compared to both blue- and white-collar workers over 15 years, whereas the third longitudinal study (South Korea) did not find a difference regarding the incidence of depressive symptoms over 6 years. Results from the cross-sectional studies showed associations between self-employment and poor general mental health and stress, but were inconsistent regarding other mental outcomes. Most studies from South Korea found a higher prevalence of mental disorders among the self-employed compared to employees, whereas the results of cross-sectional studies from outside Asia were less consistent. In conclusion, we found evidence from population-based studies for a link between self-employment and increased risk of mental illness. Further longitudinal studies are needed examining the potential risk for the development of mental disorders in specific subtypes of the self-employed.
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Trastornos Mentales , Salud Mental , Estudios Transversales , Empleo , Humanos , Estudios Longitudinales , Trastornos Mentales/epidemiologíaRESUMEN
BACKGROUND: In December, 2019, the newly identified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan, China, causing COVID-19, a respiratory disease presenting with fever, cough, and often pneumonia. WHO has set the strategic objective to interrupt spread of SARS-CoV-2 worldwide. An outbreak in Bavaria, Germany, starting at the end of January, 2020, provided the opportunity to study transmission events, incubation period, and secondary attack rates. METHODS: A case was defined as a person with SARS-CoV-2 infection confirmed by RT-PCR. Case interviews were done to describe timing of onset and nature of symptoms and to identify and classify contacts as high risk (had cumulative face-to-face contact with a confirmed case for ≥15 min, direct contact with secretions or body fluids of a patient with confirmed COVID-19, or, in the case of health-care workers, had worked within 2 m of a patient with confirmed COVID-19 without personal protective equipment) or low risk (all other contacts). High-risk contacts were ordered to stay at home in quarantine for 14 days and were actively followed up and monitored for symptoms, and low-risk contacts were tested upon self-reporting of symptoms. We defined fever and cough as specific symptoms, and defined a prodromal phase as the presence of non-specific symptoms for at least 1 day before the onset of specific symptoms. Whole genome sequencing was used to confirm epidemiological links and clarify transmission events where contact histories were ambiguous; integration with epidemiological data enabled precise reconstruction of exposure events and incubation periods. Secondary attack rates were calculated as the number of cases divided by the number of contacts, using Fisher's exact test for the 95% CIs. FINDINGS: Patient 0 was a Chinese resident who visited Germany for professional reasons. 16 subsequent cases, often with mild and non-specific symptoms, emerged in four transmission generations. Signature mutations in the viral genome occurred upon foundation of generation 2, as well as in one case pertaining to generation 4. The median incubation period was 4·0 days (IQR 2·3-4·3) and the median serial interval was 4·0 days (3·0-5·0). Transmission events were likely to have occurred presymptomatically for one case (possibly five more), at the day of symptom onset for four cases (possibly five more), and the remainder after the day of symptom onset or unknown. One or two cases resulted from contact with a case during the prodromal phase. Secondary attack rates were 75·0% (95% CI 19·0-99·0; three of four people) among members of a household cluster in common isolation, 10·0% (1·2-32·0; two of 20) among household contacts only together until isolation of the patient, and 5·1% (2·6-8·9; 11 of 217) among non-household, high-risk contacts. INTERPRETATION: Although patients in our study presented with predominately mild, non-specific symptoms, infectiousness before or on the day of symptom onset was substantial. Additionally, the incubation period was often very short and false-negative tests occurred. These results suggest that although the outbreak was controlled, successful long-term and global containment of COVID-19 could be difficult to achieve. FUNDING: All authors are employed and all expenses covered by governmental, federal state, or other publicly funded institutions.
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Betacoronavirus/aislamiento & purificación , Enfermedades Transmisibles Importadas/transmisión , Infecciones por Coronavirus/transmisión , Brotes de Enfermedades , Transmisión de Enfermedad Infecciosa , Neumonía Viral/transmisión , Enfermedad Relacionada con los Viajes , Adolescente , Adulto , Betacoronavirus/clasificación , Betacoronavirus/genética , COVID-19 , Niño , Preescolar , China , Enfermedades Transmisibles Importadas/epidemiología , Enfermedades Transmisibles Importadas/patología , Enfermedades Transmisibles Importadas/virología , Infecciones por Coronavirus/epidemiología , Alemania/epidemiología , Humanos , Entrevistas como Asunto , Persona de Mediana Edad , Mutación , Pandemias , Neumonía Viral/epidemiología , ARN Viral/genética , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Medición de Riesgo , SARS-CoV-2 , Viaje , Adulto JovenRESUMEN
BACKGROUND: Healthcare professionals are confronted with specific work-related demands that influence work-family relations and might indirectly affect the quality of healthcare. This paper seeks to provide an overview of the current state of research on this topic of relevance to health services research. The overview may serve as a starting point for modifying structures in the healthcare system (especially in rural regions) with the aim of improving work-family compatibility. METHODS: A systematic national and international literature search was conducted in terms of a scoping review. The following criteria/contents to be covered in publications were defined: work-family compatibility; work-family interface and work-family conflict in employees working in healthcare; healthcare professions in rural areas and links with work-family issues; interventions to improve work-family compatibility. 145 publications were included in the overview. RESULTS: The available literature focuses on physicians and nursing staff while publications on other professions are largely lacking. The methodological quality of existing studies is mostly low, including a lack of meta-analyses. Several studies document dissatisfaction in physicians and nursing staff regarding reconciliation of work and family life. Only few intervention studies were found that seek to improve work-life compatibility; few of them focus on employees in healthcare. There are also deficits with respect to linking work-family issues with aspects of healthcare in rural areas. CONCLUSIONS: There is a shortage of systematic national and international research regarding work-family compatibility, especially when it comes to the evaluation of interventions. The overview provides starting points for improving work-family compatibility in healthcare.
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Relaciones Familiares , Sector de Atención de Salud , Personal de Salud , Alemania , Personal de Salud/psicología , Investigación sobre Servicios de Salud , Humanos , Calidad de la Atención de SaludRESUMEN
A European multi-country outbreak of Salmonella Enteritidis phage type (PT) 14b occurred from March to November 2014 associated with the consumption of eggs. The outbreak involved more than 400 human cases from France, Luxembourg, Austria and the United Kingdom. In 2016-2017, it has been re-evaluated combining recent epidemiological results with latest molecular data. The outbreak was traced back to one large Bavarian egg producer with four distinct premises, three located in Bavaria, one in the Czech Republic. The outbreak isolates of S. Enteritidis PT 14b were grouped into three closely related clades by whole genome sequencing. Two of these clades could be referred to two Bavarian premises of the egg producer on the basis of epidemiological and molecular data, while epidemiological data presumably linked the third clade to another premises of the egg producer. Interestingly and in contrast to the situation in other European countries where several outbreaks were documented, all notified 91 laboratory-confirmed cases of S. Enteritidis PT 14b from Bavaria were sporadic, singular cases not belonging to any epidemiological outbreaks. In conclusion, as demonstrated here, the resolution of food-related outbreaks with such a high discriminatory power is rare in outbreak investigation.
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Tipificación de Bacteriófagos/métodos , Brotes de Enfermedades , Huevos/microbiología , Intoxicación Alimentaria por Salmonella/epidemiología , Infecciones por Salmonella/epidemiología , Salmonella enteritidis/genética , Salmonella enteritidis/aislamiento & purificación , Animales , Austria/epidemiología , República Checa/epidemiología , Francia/epidemiología , Humanos , Luxemburgo/epidemiología , Polimorfismo de Nucleótido Simple , Salmonella enteritidis/clasificación , Reino Unido/epidemiología , Secuenciación Completa del GenomaRESUMEN
OBJECTIVES: In Bavaria, Germany, an expanded MS-MS-based newborn screening program was implemented in 1999. The coverage of new additional conditions and novelty of technology required introduction of written parental consent. Here we evaluated the influence of the consent procedure on compliance by systematic demographic tracking. METHODS: Comprehensive information was provided for parents, professionals, and the public. Screening notifications were matched with all birth notifications on name and date of birth. Parents of children without screening notification were contacted and counseled. RESULTS: Between August 1, 1999, and July 31, 2000, 123,284 children eligible for screening were born. Of these, 116,652 were matched successfully. Among 6,632 parents contacted, 2,516 (2%) did not respond. Three thousand thirty-four children were screened but the parents initially refused to participate in tracking. Five hundred ninety-four were screened outside the program. Four hundred eighty-eight untested newborns were identified. Three hundred twenty-five screening failures due to logistic problems were tested subsequently. Screening was definitely refused by the parents of 163 children (0.1% of target population). CONCLUSIONS: With appropriate information provided and surveillance by tracking, high compliance with newborn screening can be achieved despite a written consent requirement.
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Espectrometría de Masas/estadística & datos numéricos , Errores Innatos del Metabolismo/diagnóstico , Tamizaje Neonatal/estadística & datos numéricos , Cooperación del Paciente , Consentimiento por Terceros , Adulto , Femenino , Alemania , Humanos , Recién Nacido , MasculinoRESUMEN
OBJECTIVES: Expansion of newborn screening programs may increase the risk of missing cases through procedural failures. A coordinated process quality assurance procedure to track recalls was, therefore, introduced in parallel to expansion (including MS-MS and 17alpha-OHP) in Bavaria. METHODS: Using comprehensive computerized registration and automated monitoring a state-funded center coordinated all individual measures to achieve complete testing of all repeat requests-case-specific contacts to physicians, midwives, and parents. Mailing and phoning from the center were supplemented by local public health activities including home visits if needed. RESULTS: Among 243,422 children tested in 1999 and 2000 overall recall was 3.62% (8,809 children): 0.30% (726) were due to sample inadequacy, 1.35% (3,282) to early sampling (<48 h), and 1.97% (4,801) to abnormal results. Of all recalls, 80.9% were received following the initial request, 1,679 (19.1%) required special efforts. Of these, 873 were achieved following a single and 601 following repeated central activities, and 102 were achieved following local support. Sixty-three cases of parental refusal and 47 untraceable children remained. Altogether, 98.8% recalls were achieved, corresponding to 99.96% of all tested children for which definite screening results could be obtained. CONCLUSIONS: Expansion of newborn screening programs does not necessarily mean unsolvable problems in tracking of recalls if adequate logistics is established in parallel.