Long-term health sequelae and quality of life at least 6 months after infection with SARS-CoV-2: design and rationale of the COVIDOM-study as part of the NAPKON population-based cohort platform (POP).

PURPOSE: Over the course of COVID-19 pandemic, evidence has accumulated that SARS-CoV-2 infections may affect multiple organs and have serious clinical sequelae, but on-site clinical examinations with non-hospitalized samples are rare. We, therefore, aimed to systematically assess the long-term health status of samples of hospitalized and non-hospitalized SARS-CoV-2 infected individuals from three regions in Germany. METHODS: The present paper describes the COVIDOM-study within the population-based cohort platform (POP) which has been established under the auspices of the NAPKON infrastructure (German National Pandemic Cohort Network) of the national Network University Medicine (NUM). Comprehensive health assessments among SARS-CoV-2 infected individuals are conducted at least 6 months after the acute infection at the study sites Kiel, Würzburg and Berlin. Potential participants were identified and contacted via the local public health authorities, irrespective of the severity of the initial infection. A harmonized examination protocol has been implemented, consisting of detailed assessments of medical history, physical examinations, and the collection of multiple biosamples (e.g., serum, plasma, saliva, urine) for future analyses. In addition, patient-reported perception of the impact of local pandemic-related measures and infection on quality-of-life are obtained. RESULTS: As of July 2021, in total 6813 individuals infected in 2020 have been invited into the COVIDOM-study. Of these, about 36% wished to participate and 1295 have already been examined at least once. CONCLUSION: NAPKON-POP COVIDOM-study complements other Long COVID studies assessing the long-term consequences of an infection with SARS-CoV-2 by providing detailed health data of population-based samples, including individuals with various degrees of disease severity. TRIAL REGISTRATION: Registered at the German registry for clinical studies (DRKS00023742).

Performance anxiety in professional musicians: a systematic review on prevalence, risk factors and clinical treatment effects.

Music performance anxiety (MPA) is one of the most common disorders among professional musicians, nevertheless, little is known about the disease. With this systematic review, prevalence, risk factors and treatment procedures for MPA were assessed, and for the first time, quality assessments were carried out for all studies using standardized assessment tools. A systematic literature search was conducted via search algorithms in the databases MEDLINE, EMBASE, CINAHL, PsycArticles, PsycInfo and ERIC. Included were case reports, case-control, cohort, cross-sectional and intervention studies examining professional musicians with MPA. For quality assessment, adapted tools of the National Heart, Lung, and Blood Institute were used. A total of 43 studies were included (10 case reports, 21 intervention, 11 cross-sectional, one cohort study). Quality ratings ranged from -11 to 6 out of a maximum of 15/16 points for cross-sectional/cohort studies and -4 to 11 out of 18 points for intervention studies. The prevalence of MPA was between 16.5% and 60%. More women than men were affected and musicians older than 45-50 years reported less MPA than younger musicians. Regarding treatment cognitive behavioural therapy (CBT) and ß-blockers were most often researched with beneficial results for CBT. However, studies with adequate control groups for CBT interventions are needed to clarify its efficacy. Studies showed methodological weaknesses, especially in the selection of participants, recording of influencing factors, blinding of interventions, randomization of participants and analysis of comorbidity. Recommendations for further research are made.

[Cost evaluation of a model for integrated care of seriously mentally ill patients]. / Kostenevaluation eines Modells der Integrierten Versorgung für schwer psychisch Kranke.

BACKGROUND: The model for integrated care (IC) of those seriously mentally ill patients insured with the DAK-Gesundheit health insurance and various Betriebskrankenkassen (members of the VAG Mitte) from the regions Berlin, Brandenburg, Lower Saxony and Bremen allows a complex treatment in the outpatient setting which consists of psychiatrists, general practitioners and clinicians, psychiatric nursing, sociotherapy (only in Berlin), internal medicine quality circles, orientation on treatment guidelines and conceptual consensus with the relevant care clinics. The aim of the evaluation is to illustrate the health economic effects of IC. METHODS: In the period from 2006 to 2010 insured members of the DAK-Gesundheit and other involved health insurance companies with a serious mental illness, a significant impairment of social functioning and the need to be treated to avoid or substitute an in-hospital stay were included in the integrated care. The cost perspective was that of the statutory health insurance companies. For the health economic evaluation, the utilisation of continuous IC over 18 months was compared to the last 18 months prior to the inclusion in IC. The clinical findings were gathered quarterly during the IC using CGI (Clinical Global Impressions) and GAF (Global Assessment of Functioning Scale). RESULTS: A total of 1 364 patients receiving IC in 66 doctor's practices were documented (of those, 286 had diagnoses of ICD-10 F2, 724 ICD-10 F32-F39). The median age was 48.8 years, 69% were female. 24% had their own source of income, 40% were on the pension, and the rest of the patients were receiving transfer benefits in some form. In 54% of the cases IC was used to avoid an in-hospital stay, in 46% of the cases to substitute an in-hospital stay. The degree of the CGI was 5.5 on average at the time of inclusion and the GAF score was 36.5 on average. The 226 patients with continuous documentation over 18 months were included in the health economic analysis. The number of days spent in hospital was lower during the IC period as compared to the 18 months prior to IV (11.8 vs. 28.6 days, p<0.001), the inpatient costs were lower (5 929 ± 13 837 Euro vs. 2 458 ± 6 940 Euro, p<0.001), the total was not significantly changed (7 777 ± 14 263 Euro vs. 7 321 ± 7 910 Euro, p=0.65). The substantial reduction of inpatient costs was compensated by the additional costs for medication and the costs of the complex outpatient care. Results were comparable for the 2 subgroups of schizophrenic/schizoaffective (n=66, 40.9 vs. 17.9 days, p=0.03; inpatient cost 9 009 ± 15 677 Euro vs. 3 650 ± 8 486 Euro, p=0.02; total expenditures 11 789 ± 15 975 Euro vs. 9 623 ± 9 262 Euro, p=0.33) and unipolar depressive patients (n=90, 29.8 vs. 9.8 days, p=0.006; inpatient cost 5 664 ± 14 921 Euro vs. 1 967 ± 5 276 Euro, p=0.02; total expenditures 7 146 ± 15 164 Euro vs. 6 234 ± 6 292 Euro, p=0.57). CONCLUSION: The IC was able to considerably reduce the utilisation of inpatient treatment through offering a complex range of services in the outpatient setting and allowed for a weight-shift in a low-threshold comprehensive care structure without an increase in costs from the statutory health insurance companies' perspective. For a detailed description of clinical effects further studies are required.

Reliability of a novel point of care device for monitoring diabetic peripheral neuropathy.

We aimed to assess DPNCheck's reliability for repeated sural nerve conduction (NC) parameters. This post hoc analysis used data from the randomized controlled ACUDPN trial assessing NC of the N. Suralis every eight weeks over a 6-month period in 62 patients receiving acupuncture against diabetic peripheral neuropathy (DPN) symptoms. The reliability of DPNCheck for nerve conduction velocity and amplitude was assessed using intraclass correlation coefficients (ICC) and was calculated using data from single time points and repeated measures design. The results of the NC measurements were correlated with the Total Neuropathy Score clinical (TNSc). Overall, for both nerve velocity and amplitude, the reliability at each measurement time point can be described as moderate to good and the reliability using repeated measures design can be described as moderate. Nerve velocity and amplitude showed weak correlation with TNSc. DPNCheck's reliability results question its suitability for monitoring DPN's progression. Given the limitation of our analysis, a long-term, pre-specified, fully crossed study should be carried out among patients with DPN to fully determine the suitability of the device for DPN progression monitoring. This was the first analysis assessing the reliability of the DPNCheck for DPN progression monitoring using data from multiple collection time points.

[Patients suffering from atrial fibrillation in Germany. Characteristics, resource consumption and costs]. / Patienten mit Vorhofflimmern in Deutschland. Charakteristika, Ressourcenverbrauch und Kosten.

INTRODUCTION: Atrial fibrillation (Afib) is considered to be the most frequent form of cardiac dysrhythmia and is well known as a key risk factor for arterial thromboembolism. The incidence of Afib will increase in the future due to demographic changes as well as improved treatment options for acute and chronic heart diseases. OBJECTIVE: The primary objectives of this analysis were to describe patient characteristics, to assess the resource consumption associated with Afib and to measure costs of direct treatment as well as consequential costs. A secondary objective was to identify factors that influence the costs or the type of Afib. METHODS: The analysis is based on the representative ATRIUM register (Ambulantes Register zur Morbidität des Vorhofflimmerns, Ambulatory register on morbidity of atrial fibrillation), a prospective, multicenter cohort study in which general practitioners and family doctors documented the characteristics and resource utilization of consecutively enrolled patients. The documented resource consumption use was subsequently valued with unit costs. The presented results are focused on the baseline documentation and refer to the period 12 months before enrollment. RESULTS: A total of 3,667 patients (mean age 72.1±9.2 years, 58% men) fulfilled all inclusion criteria and were included by a total of 730 doctors. The patients had an average of 2.4±1.0 risk factors and the most common was hypertension (84% of patients). The most commonly observed comorbidities were heart failure (43%) and coronary heart disease (CHD, 35%). Medicines for oral anticoagulation (86%) and beta blockers (75%) were the most frequently prescribed drugs. A total of 1/3 of all patients received a specific kind of Afib therapy (e. g. drug conversion, cardioversion) during the past 12 months. The disease-specific mean costs of the patients were 3,274±5,134 Euro, while the acute (inpatient) treatment represented the largest proportion of these total costs (1,639±3,623 Euro). Patients with high treatment costs were significantly younger and suffered from more concomitant diseases. CONCLUSION: Atrial fibrillation is associated with significant patient-related attributable costs that are caused particularly by expenditures of inpatient stay. New, innovative treatment strategies seem to offer particular potential savings if they are able to reduce the number of hospitalizations due to Afib itself or subsequent cardiac events.

Health economic evaluation of the use of drug-eluting stents : First results from the Drug-Eluting Stent Registry (DES.de).

OBJECTIVE: The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented. METHODS: Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher's exact and t test. RESULTS: Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284  and 3,609 ± 924 , respectively, in DES and BMS patients (p < 0.001) with no significant difference between PES and SES. CONCLUSION: The economic evaluation of the large DES registry demonstrates increased initial hospitalisation costs associated with DES compared to BMS. Further analysis of the economic impact and cost-effectiveness of DES will provide estimates on large "real world" patient populations for decision makers and aid in reimbursement decisions of DES within the German and other health care systems.

[Clinical and health economic challenges of personalized medicine]. / Herausforderungen an die klinische Evaluation und Gesundheitsökonomie auf dem Weg zur personalisierten Medizin.

Healthcare systems across the globe are currently challenged by aging populations, increases in chronic diseases and the difficult task of managing a healthcare budget. In this health economic climate, personalized medicine promises not only an improvement in healthcare delivery but also the possibility of more cost-effective therapies. It is important to remember, however, that personalized medicine has the potential to both increase and decrease costs. Each targeted therapy must be evaluated individually. However, standard clinical trial design is not suitable for personalized therapies. Therefore, both scientists and regulatory authorities will need to accept innovative study designs in order to validate personalized therapies. Hence correct economic evaluations are difficult to carry out due to lack of clear clinical evidence, longitudinal accounting and experience with patient/clinician behavior in the context of personalized medicine. In terms of reimbursement, payers, pharmaceutical companies and companion diagnostic manufacturers will also need to explore creative risk-sharing concepts. Germany is no exception to the challenges that face personalized medicine and for personalized medicine to really become the future of medicine many health economic challenges first need to be overcome. The health economic implications of personalized medicine remain unclear but it is certain that the expansion of targeted therapies in current healthcare systems will create a host of challenges.

[Cardiovascular diseases in the focus of health economics. The example of drug-eluting vascular stents in coronary heart disease]. / Herz-Kreislauf-Erkrankungen im Fokus der Gesundheitsökonomie. Das Beispiel medikamentenfreisetzender Gefäßstents bei koronarer Herzerkrankung.

Coronary heart disease is an important disorder in Western industrialized societies, with regard to both the epidemiologic and economic burden of illness. A modern therapeutic strategy consists of coronary interventions and the implantation of drug-eluting vascular stents. The cost-effectiveness of such drug-eluting stents has been an important subject of health-economic evaluation research in recent years. This article presents two examples of such studies and deals with the question whether existing study projects are able to provide sufficient evidence for allocation decisions in health care. On this basis we discuss important challenges for future health economic analysis. A key conclusion is the need for long-term and cross-sectoral evaluation strategies that could be based on routinely collected health care data. Supplemented by health economic results from clinical trials, the use of such data would lead to a broader data basis for allocation decisions in health care.

Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial.

BACKGROUND: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. METHODS: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. CONCLUSION: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. TRIAL REGISTRATION: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

Validation of the State Version Questionnaire on Autonomic Regulation (State-aR) for cancer patients.

OBJECTIVES: Current quality of life inventories used in oncology mainly measure the effects of chemo- or radiotherapy alongside functional and role scales. A new approach is to measure the autonomic state of regulation with the trait-inventory of autonomic regulation (Trait-aR). Loss of Trait-aR has been shown in different medical conditions such as breast cancer (BC) but not in colorectal cancer patients (CRC). In this paper we report the validation of a new state autonomic regulation scale (State-aR) of the last week. METHODS: Study 1 included 114 participants: (41 women/16 men with cancer and 57 age- and gender-matched healthy people) to conduct a reliability-, factor- and validity-analysis. Concurrent and convergent validity was evaluated with Trait-aR, Fatigue-Numerical-Scale, Hospital Anxiety and Depression Scale (HADS-D) and the self-regulation scale, 65 participants were retested. Study 2 completed 42 participants: 17 with BC and 25 with CRC receiving chemotherapy. The State-aR was administered prior, during and after chemotherapy for measuring responsiveness. RESULTS: The factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermo-sweating and digestive regulation) with a: Cronbach-α r(α) = 0.77?0.83 and a test-retest-reliability r(rt) = 0.60?0.80. The sum- and subscales correlated with their concurrent subscales in the Trait-aR (0.48?0.74) and with the sum-scale moderately with all convergent criteria (r = 0.41?-0.44; p <0.001). During chemotherapy the State-aR-sum and rest-activity-scale decreased significantly compared to the change in the Trait-aR (p <0.05). CONCLUSIONS: These findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

[Second-generation DES : New, but also cost-effective?]. / Medikamentenfreisetzende Stents der 2. Generation : Neu, aber auch kosteneffektiv?

BACKGROUND: The objective of the present review was to investigate the cost-effectiveness of second-generation drug-eluting stents (DES) compared to bare metal stents (BMS) as well as to first-generation DES. METHODS: A structured literature review in MEDLINE was conducted to identify all studies investigating the cost-effectiveness of second-generation DES published up to December 2010. Pre-specified selection criteria were applied to identify relevant studies. Standardized data extraction was performed to summarize clinical, economic, and cost-effectiveness outcomes of these studies. RESULTS: Of only five studies which met all selection criteria from the US, UK, and Spain, three investigated the cost-effectiveness of the zotarolimus-coated Endeavor stent (ZES) compared to BMS, and two studies the ZES with first-generation DES. CONCLUSION: In summary, there is currently a lack of evidence with regard to the cost-effectiveness of second-generation DES, especially in Germany. However, studies from other countries provide some evidence that second-generation DES appear to generally not be cost-effective compared to BMS. Also, there is no conclusive evidence of cost-effectiveness compared to first-generation DES. Moreover, there are currently no studies investigating the cost-effectiveness of the Everolimus-coated Xience V stent. Methodologically rigorous economic evaluations addressing these issues within the context of the German health care system are therefore urgently required.

[Coding problems in German mortality statistics as illustrated by ischaemic heart disease]. / Kodierungsprobleme in der deutschen Todesursachenstatistik am Beispiel ischämischer Herzkrankheiten.

BACKGROUND: The German mortality statistics are an important data source in terms of research and health policy but might be influenced by different sources of error such as ICD-10 coding by regional authorities. The aim of this study was to identify state-specific coding problems using the example of ischaemic heart disease (IHD) and myocardial infarction (MI). METHODS: After obtaining age-standardised mortality rates (1998-2008), outlier analyses were used to identify German states with suspect changes in mortality from IHD or MI over time or suspect proportional mortality from an unspecific cause-of-death (ICD-10 R00-R99). Values outside the 3-fold interquartile range (IQR) from the IQR boundaries were considered as outliers. The impact of these discrepancies was studied by using an ecological correlation between state-specific poverty rates and mortality from IHD or MI as an example. RESULTS: During the study period, mortality rates dropped by 38.1% for IHD and by 38.7% for MI. Suspect mortality trends or proportional mortality rates were identified in Berlin, Bremen, Hamburg, Schleswig-Holstein and Saarland. The association between state-specific poverty rates and mortality from IHD or MI increased after exclusion of the suspect states. CONCLUSIONS: The ICD-10 coding by regional authorities seems to be an important source of error. A standardisation of coding procedures is urgently needed.

Acupuncture in diabetic peripheral neuropathy-protocol for the randomized, multicenter ACUDPN trial.

BACKGROUND: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. METHODS: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. DISCUSSION: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. TRIAL REGISTRATION: ClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.

The multinational birth cohort of EuroPrevall: background, aims and methods.

BACKGROUND/AIM: The true prevalence and risk factors of food allergies in children are not known because estimates were based predominantly on subjective assessments and skin or serum tests of allergic sensitization to food. The diagnostic gold standard, a double-blind placebo-controlled food provocation test, was not performed consistently to confirm suspected allergic reactions in previous population studies in children. This protocol describes the specific aims and diagnostic protocol of a birth cohort study examining prevalence patterns and influential factors of confirmed food allergies in European children from different regions. METHODS: Within the collaborative translational research project EuroPrevall, we started a multi-center birth cohort study, recruiting a total of over 12 000 newborns in nine countries across Europe in 2005-2009. In addition to three telephone interviews during the first 30 months, parents were asked to immediately inform the centers about possible allergic reactions to food at any time during the follow-up period. RESULTS: All children with suspected food allergy symptoms were clinically evaluated including double-blind placebo-controlled food challenge tests. We assessed sensitization to different food allergens by measurements of specific serum immunoglobulin E and skin prick tests, collect blood, saliva or buccal swabs for genetic tests, breast milk for measurement of food proteins/cytokines, and evaluate quality-of-life and economic burden of families with food allergic children. CONCLUSIONS: This birth cohort provides unique data on prevalence, risk factors, quality-of-life, and costs of food allergies in Europe, leading to the development of more informed and integrated preventative and treatment strategies for children with food allergies.

The natural history of allergic rhinitis in childhood.

The distinction between 'seasonal' and 'perennial' allergic rhinitis (AR) is not always adequate. The 'Allergic Rhinitis and its Impact on Asthma' (ARIA) work group suggested a new classification for AR based on severity and duration of symptoms. Our primary aim was to describe the natural history and burden of AR according to the new ARIA criteria in a population-based birth cohort study of children up to 13 yr. We defined symptoms as 'severe' (impairment of daily activities) or 'mild' (no impairment) and 'persistent' (duration > 1 month) or 'intermittent' (

[Nursing concepts for patients with dementia. Systematic review]. / Pflegerische Betreuungskonzepte bei Patienten mit Demenz. Ein systematischer Review.

BACKGROUND: Today there are approximately one million people with dementia in Germany. Because most forms of dementia cannot be cured the focus of treatment is to provide adequate care, aiming at the maintenance of cognitive functioning, the ability to perform everyday tasks and quality of life. Important approaches for dementia care are multisensory stimulation, validation, reality orientation and reminiscence therapy. However, the efficacy of these approaches is unclear. METHODS: A systematic review of the literature was performed. We included randomised controlled trials with at least 30 participants on the efficacy of multi-sensory stimulation, validation, reality orientation and reminiscence therapy for dementia. No restrictions were defined with regard to the endpoints under investigation. RESULTS: A total of 14 studies with 1,513 patients could be included of which 5 studies assessed reminiscence therapy, 4 multi-sensory stimulation, 3 validation and 2 reality orientation. The studies analysed cognitive functioning, behavioural outcomes, psychological symptoms and quality of life. Most studies did not find significant differences between the intervention and the control group. CONCLUSION: The studies conducted to date provide only little evidence for the efficacy of the approaches for dementia care considered in this review. However, only few methodologically robust studies could be identified for this review which highlights the need for more interventional studies.

Leadership in health care: developing a post-merger strategy for Europe's largest university hospital.

PURPOSE: This paper's aim is to identify existing and developing new concepts of organization, management, and leadership at a large European university hospital; and to evaluate whether mixed qualitative-quantitative methods with both internal and external input can provide helpful views of the possible future of large health care providers. DESIGN/METHODOLOGY/APPROACH: Using the Delphi method in semi-structured, semi-quantitative interviews, with managers and employees as experts, the authors performed a vertical and a horizontal internal analysis. In addition, input from innovative faculties in other countries was obtained through structured power questions. These two sources were used to create three final scenarios, which evaluated using traditional strategic planning methods. FINDINGS: There is found a collaboration scenario in which faculty and hospital are separated; a split scenario which divides the organization into three independent hospitals; and a corporation scenario in which corporate activities are bundled in three separate entities. PRACTICAL IMPLICATIONS: In complex mergers of knowledge-driven organizations, the employees of the own organization (in addition to external consultants) might be tapped as a knowledge resource to successful future business models. ORIGINALITY/VALUE: The paper uses a real world consulting case to present a new set of methods for strategic planning in large health care provider organizations.

Maternal smoking increases risk of allergic sensitization and wheezing only in children with allergic predisposition: longitudinal analysis from birth to 10 years.

BACKGROUND: The role of passive smoking for allergies and asthma in children above the age of 3 years remains unclear and possible interactive effects with parental allergies have not been formally evaluated in long-term studies. To examine the interaction of passive smoking and an allergic predisposition regarding allergic sensitization, allergic airway symptoms and respiratory infections during the first 10 years of life. METHODS: In a prospective multicenter birth cohort study with 1314 recruited children in Germany, we assessed serum immunoglobulin E against common allergens at seven time points, and parental smoking and respiratory symptoms annually by using questionnaires. Longitudinal analyses were performed using generalized estimating equation models (stratified by parental allergy status). RESULTS: During the first 10 years, 18% of the children were exposed to regular maternal smoking since pregnancy, 43% to irregular maternal or only paternal smoking. Among children with two allergic parents, a mother who smoked regularly significantly increased the odds for allergic sensitization (adjusted OR 4.8, 95% CI 1.3-18.2) and wheezing (adjusted OR 5.7, 95% CI 1.7-19.0) in her child compared with children who were never exposed. For those with only one allergic parent, the odds were doubled and also statistically significant, whereas in children without allergic parents maternal smoking had no effects. There was no association of maternal smoking with allergic rhinitis or respiratory infections. CONCLUSIONS: Our results suggest that regular maternal smoking is a strong risk factor for allergic sensitization and asthma symptoms during the first 10 years of life, but only in children with allergic parents.

Vascular risk factor awareness before and pharmacological treatment before and after stroke and TIA.

BACKGROUND AND PURPOSE: Educating the public to screen for vascular risk factors and have them treated is a major public health issue. We assessed the vascular risk factor awareness and frequency of treatment in a cohort of patients with cerebral ischaemia. METHODS: Data on awareness and pharmacological treatment of vascular risk factors before hospital admission of patients with confirmed ischaemic stroke/transient ischaemic attack (TIA) were analyzed. A follow-up questionnaire assessed the frequency of treatment 1 year after discharge and assessed non-adherence to antithrombotic medication. RESULTS: At time of stroke/TIA, individual awareness regarding existing hypertension, diabetes, hyperlipidemia and atrial fibrillation (AF) was 83%, 87%, 73% and 69% respectively (n = 558). Pharmacological treatment for hypertension, diabetes, hyperlipidemia and AF was being administered in 80%, 77%, 37% and 62% of patients aware of their conditions. The follow-up was completed by 383 patients (80% recall rate): of the patients with hypertension, diabetes, hyperlipidemia and AF, 89%, 78%, 45% and 86% were receiving risk factor targeted medication. This represents a significant increase concerning AF and hyperlipidemia. Non-adherence to recommended antithrombotics (15%) was higher in patients who had had a TIA. CONCLUSIONS: All risk factors leave room for improvement in screening and treatment efforts. Adherence to treatment is higher for hypertension and diabetes than for hyperlipidemia. Education efforts should bear in mind less well recognized risk factors.