Rheuma-VOR study: optimising healthcare of rheumatic diseases by multiprofessional coordinating centres.

OBJECTIVES: Early diagnosis of inflammatory arthritis is critical to prevent joint damage and functional incapacities. However, the discrepancy between recommendations of early diagnosis and reality is remarkable. The Rheuma-VOR study aimed to improve the time to diagnosis of patients with early arthritis by coordinating cooperation between primary care physicians, specialists and patients in Germany. METHODS: This prospective non-randomised multicentre study involved 2340 primary care physicians, 72 rheumatologists, 4 university hospitals and 4 rheumatology centres in 4 German Federal States. The two coprimary endpoints (time to diagnosis and screening performance of primary care physicians) were evaluated for early versus late implementation phase. Additionally, time to diagnosis and secondary endpoints (decrease of disease activity, increase in quality of life and overall well-being, improvement of fatigue, depression, functional ability, and work ability, reduction in drug and medical costs and hospitalisation) were compared with a reference cohort of the German Rheumatism Research Centre (DRFZ) reflecting standard care. RESULTS: A total of 7049 patients were enrolled in the coordination centres and 1537 patients were diagnosed with a rheumatic disease and consented to further participation. A follow-up consultation after 1 year was realised in 592 patients. The time to diagnosis endpoint and the secondary endpoints were met. In addition, the calculation of cost-effectiveness shows that Rheuma-VOR has a dominant cost-benefit ratio compared with standard care. DISCUSSION: Rheuma-VOR has shown an improvement in rheumatological care, patient-reported outcome parameters and cost savings by coordinating the cooperation of primary care physicians, rheumatologists and patients, in a nationwide approach.

[Methotrexate treatment before use of biologics in rheumatoid arthritis : Analysis of guideline compliance]. / Methotrexat-Versorgung vor dem Einsatz von Biologika bei rheumatoider Arthritis : Eine Analyse der Leitliniengerechtigkeit.

BACKGROUND: With the introduction of biologics the treatment landscape for patients with rheumatoid arthritis (RA) has rapidly expanded; however, according to German and European treatment guidelines the use of biologic disease-modifying antirheumatic drugs (bDMARD) is only indicated after insufficient response under methotrexate (MTX) doses of at least 20 mg/week (first-line treatment). The aim of the study was to analyze the guideline compliance of MTX prescription in the outpatient sector prior to treatment with biologics. MATERIAL AND METHODS: Claims data from the AOK Lower Saxony from 2013 to 2016 were provided for all insured patients with a diagnosis of RA and bDMARD prescription during the study period. Within a patient-specific observational period of 180 days prior to the first bDMARD prescription, the maximum prescribed MTX dosage was examined. RESULTS: Data from 90 incident and 315 prevalent RA patients were analyzed. A maximum MTX prescription of < 20 mg/week was observed in 60.0% of incident patients and in 67.0% of prevalent patients. Men had a higher mean MTX maximum dose (17.1 ± 4.8 mg) than women (14.9 ± 5.0 mg; p < 0.0001). Of the study population 29.6% received oral only prescriptions during the observational period. In 12.4% of patients a switch to parenteral administration was made. DISCUSSION: Targeted use of the full spectrum of therapies provided prior to initiation of bDMARD treatment may contribute to cost-effective RA care. This study showed indications for potential deficits in outpatient MTX prescription practice and can raise awareness for efficient treatment.

[Delegation of medical duties to qualified rheumatology assistants : Effect on depression and anxiety in patients with rheumatoid arthritis]. / Delegation ärztlicher Leistungen an rheumatologische Fachassistenten : Effekte auf Depression und Angst bei Patienten mit rheumatoider Arthritis.

BACKGROUND: At least 1 comorbidity occurs in 80% of patients with rheumatoid arthritis (RA). In addition to cardiovascular comorbidities psychological comorbid conditions are common. The prevalence of depression and anxiety is higher in patients than in the general population. Screening for comorbidities is crucial. A shortage of outpatient specialist care barely allows resources for this. The implementation of team-based care holds the potential to improve the standard of care while simultaneously working against the shortage of care. OBJECTIVE: The aim of the study was to examine the effects of care on the course of depression and anxiety in patients with seropositive RA and active disease. MATERIAL AND METHODS: A multicenter pragmatic randomized controlled trial was conducted over the course of 1 year with 224 patients. After baseline, five more visits followed. In the intervention group (IG), three were initially carried out by qualified rheumatological assistants. Depression, anxiety and patient satisfaction with outpatient care were looked at in detail. RESULTS: In the IG the anxiety symptoms significantly improved over 12 months (p = 0.036). The proportions of patients with anxiety also significantly changed in the IG (p < 0.001), while there was no change in the control group between baseline and month 12. The values of the depression scale did not differ significantly (p = 0.866). In terms of the information dimension of the satisfaction questionnaire, patients in the IG felt significantly better informed after 6 months (p = 0.013) and 12 months (p = 0.003). CONCLUSION: A positive effect of team-based care on the course of depression and anxiety in patients with seropositive RA and active disease could be shown.

Safety and survival of docetaxel and cabazitaxel in metastatic castration-resistant prostate cancer.

OBJECTIVES: To investigate real-world haematological toxicity, overall survival (OS) and the treatment characteristics of docetaxel and cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This retrospective claims data study followed patients with mCRPC receiving cabazitaxel or docetaxel from their first chemotherapy infusion. Haematological toxicities were measured using treatment codes and inpatient diagnoses. OS was estimated using the Kaplan-Meier method. A multivariable Cox regression analysis was used to identify OS predictors. RESULTS: Data from 539 patients administered docetaxel and 240 administered cabazitaxel were analysed. Regarding adverse events, within 8 months of treatment initiation, some kind of treatment for haematological toxicity was documented in 31% of patients given docetaxel and in 61% of patients given cabazitaxel. In the same period, hospitalization associated with haematological toxicity was documented in 11% of the patients in the docetaxel cohort and in 15% of the patients in the cabazitaxel cohort. In the docetaxel cohort, 9.9% of patients required reverse isolation and 13% were diagnosed with sepsis during hospitalization. In the cabazitaxel cohort, the cumulative incidence was 7.9% and 15%, respectively. The median OS was reached at 21.9 months in the docetaxel cohort and, because of a later line of therapy, at 11.3 months in the cabazitaxel cohort. A multivariate Cox regression revealed that indicators of locally advanced and metastatic disease, severe comorbidities, and prior hormonal/cytotoxic therapies were independent predictors of early death. CONCLUSION: Cabazitaxel patients face an increased risk of haematological toxicities during treatment. Together with their short survival time, this calls for a strict indication when using cabazitaxel in patients with mCRPC.

[Sustainable reimbursement of the B­centres for rare diseases in Germany-status quo and solution approaches]. / Nachhaltige Vergütung der B­Zentren für Seltene Erkrankungen in Deutschland ­ Status quo und Lösungsansätze.

BACKGROUND: To ensure specialized care of patients with rare diseases, numerous centres for rare diseases were funded over the past few years. The reimbursement of patients' ambulatory care in hospitals, however, is characterized by a plurality of forms of care and payment. There is some evidence of deficits in the reimbursement of care of patients suffering from a rare disease from studies on individual rare diseases. OBJECTIVES: To investigate current forms of care provision and reimbursement of centres for rare diseases and to develop future approaches for sustainable compensation. MATERIALS AND METHODS: Initially, centres for rare diseases in Germany were asked to provide information about their forms of care and reimbursement using questionnaires. Subsequently, two focus group interviews and one expert interview with representatives from centres for rare diseases, health insurance, health politics and patients were conducted to discuss current and future meritocratic forms of care provision and reimbursement. The data were evaluated using content analysis. RESULTS AND CONCLUSIONS: Thirty-nine centres for rare diseases participated in the questionnaire survey. Of those, 38% receive a flat fee/allowance for university outpatient departments, the amount of which varies notably, and 41% obtain a mixed payment comprising an allowance for university outpatient departments and other forms of reimbursement. An under-recovery of costs in centres for rare diseases and its impact on patient care were mentioned in the interviews. In this context, a need to further develop forms of care provision and reimbursement has been identified. Participants prefer a special flat fee/allowance for rare diseases that covers the time-consuming care for patients with rare diseases.

Appendiceal Carcinoids in Children-Prevalence, Treatment and Outcome in a Large Nationwide Pediatric Cohort.

Background and Objectives: Appendiceal carcinoids are rare neuroendocrine tumors and mainly found incidentally during histopathological examination following appendectomy. This observational cohort study was performed to determine the prevalence, treatment modalities and outcomes in children diagnosed with an appendiceal carcinoid tumor. Materials and Methods: Data from the largest German statutory health insurance "Techniker Krankenkasse" were analyzed within an 8-year period: January 2010 to December 2012 and January 2016 to December 2020. Patient characteristics, surgical technique, type of surgical department, diagnostic management, and postoperative morbidity were analyzed. Results: Out of 40.499 patients following appendectomy, appendiceal carcinoids were found in 44 children, resulting in a prevalence of 0.11%. Mean age at appendectomy was 14.7 (±2.6) years. Laparoscopic approach was performed in 40 (91%) cases. Right-sided hemicolectomy was performed in 8 (18%) patients. Additional diagnostic work-up (CT and MRI) was recorded in 5 (11%) children. Conclusions: This large nationwide pediatric study shows that 1 in 1000 patients was found to have a neuroendocrine tumor of the appendix (prevalence 0.11%), emphasizing its low prevalence in the pediatric age group. The majority of patients were treated with appendectomy only. However, treatment modalities are still variable. Longer follow-up analyses are needed to evaluate published guidelines and recommendations to aim for a limited surgical approach.

Willingness and preparedness to provide care: interviews with individuals of different ages and with different caregiving experiences.

BACKGROUND: At present, the provision of informal care to older relatives is an essential pillar of the long-term care system in Germany. However, the impact of demographic and social changes on informal caregiving remains unclear. METHODS: Thirty-three semi-structured interviews were conducted with care consultants, informal caregivers and people without any caregiving experience to explore if people are willing to provide older adult care and how prepared these are with regard to the possibility of becoming care dependent themselves. RESULTS: In total, three main categories (willingness to provide care, willingness to receive care and information as preparation) with several sub-categories were identified during the content analysis. While almost all interviewees were willing to provide care for close family members, most were hesitant to receive informal care. Other factors such as the available housing space, flexible working hours and the proximity of relatives were essential indicators of a person's preparedness to provide informal care. It is, however, unclear if care preferences change over time and generations. Six out of 12 informal caregivers and nine out of 14 care consultants also reported an information gap. Because they do not possess adequate information, informal caregivers do not seek help until it is too late and they experience high physical and mental strain. Despite the increased efforts of care consultants in recent years, trying to inform caregivers earlier was seen as almost impossible. CONCLUSIONS: The very negative perception of caregiving as a burden was a reoccurring theme throughout all interviews and influenced people's willingness to receive care as well as seeking timely information. Despite recent political efforts to strengthen home-based care in Germany, it remains unclear whether political efforts will be effective in changing individuals' perceptions of informal caregiving and their willingness to be better prepared for the highly likely scenario of having to care for a close relative or becoming care dependent at a later stage in life.

Determinants of colorectal cancer screening in Germany: a claims data analysis.

With an incidence of 58,000 cases per year, colorectal cancer (CRC) is the third most common type of cancer in Germany. Although guaiac-based fecal occult blood tests (gFOBT) and colonoscopy are accepted strategies for CRC screening offered for individuals aged 50 or 55 onwards, utilization rates remain low.This study examines various determinants for participation in CRC screening using claims data provided by the AOK Niedersachsen and covering the years 2014 to 2016. Using multivariate logistic regression models, we analyzed sociodemographic factors (sex, age, nationality, type of employment) associated with screening behavior, including individuals who underwent colonoscopy or gFOBT. The effect of school education and professional qualification was estimated using subgroups of employees with social insurance.The analysis consisted of 620,977 insured individuals in the study population for screening colonoscopy, while the gFOBT study population contained 845,191 individuals. With increasing age, individuals were less likely to participate in CRC screening. Participation rates for screening were higher for women than men in younger age groups. However, men in higher age groups showed increased participation rates in gFOBT screening. When compared with German citizens, Turkish citizens use the colonoscopy less often and the gFOBT more often. In contrast to employees with social insurance, unemployed individuals accept the prevention services less frequently, whereas pensioners and voluntarily insured individuals exhibit increased participation rates. In terms of education and professional qualification, we estimated a significantly lower participation rate exclusively for the least educated individuals. The results help to better understand patterns of utilization and can contribute to the development of information programs for specific groups.

[Frequency of diagnosed non-alcololic fatty liver disease (NAFLD) in the German population - An analysis based on health insurance data]. / Die Häufigkeit von diagnostizierten Fettlebererkrankungen (NAFLD) in der deutschen Bevölkerung ­ Eine Analyse auf der Basis von GKV-Routinedaten.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases in Germany. In the long term, there is an increased risk of developing liver cirrhosis and subsequent diseases. Epidemiologic studies on NAFLD prevalence in Germany are scarce. The aim of the study was to assess administrative incidence and prevalence or, more specifically, the number of patients diagnosed with NAFLD in the period from 2008 to 2018. METHODS: Analyses are based on administrative data of a large statutory health insurance fund. All individuals who were insured in the year of analysis and in the three-year pre-observation period were included (between 1.7-2 million insured per analysis year). NAFLD-patients were identified using relevant ICD-10 codes (K76.0 und K75.8). RESULTS: In 2018, 4.66 % of insured persons had a NAFLD diagnosis, 0.87 % were diagnosed first-time. Diagnoses of nonalcoholic steatohepatitis (NASH) were comparatively rare (0.09 %). Data show an uptake of NAFLD diagnoses over time. The number of incident cases per year has hardly changed. Patients with diseases of the metabolic syndrome had an increased chance of being diagnosed with NAFLD. CONCLUSION: It becomes evident that NAFLD is frequently diagnosed in everyday medical practice, although data from population-based studies suggest an even higher prevalence.

[Healthcare expenditure and the impact of age: a detailed analysis for survivors and decedents]. / Gesundheitsausgaben und die Rolle des Alters: Eine detaillierte Analyse der Kosten von Überlebenden und Verstorbenen.

BACKGROUND: Germany faces various socio-political challenges due to its ongoing ageing population. Significant increases in social security contributions are widely expected. The impact of ageing on healthcare expenditure is a controversial issue. Experts agree that costs for end-of-life care account for a significant part of total healthcare expenditures. For a meaningful forecast, detailed information on healthcare costs differentiated by survivors and decedents is necessary. Extensive data are hardly available for Germany. The aim of the analysis was therefore to describe healthcare costs in the statutory health insurance. METHODS: The basis for the calculation is billing data from the statutory health insurance "AOK Niedersachsen" (Lower Saxony). Persons who survived or died in 2017 were included in the analysis. Average costs were standardised. RESULTS: The data of 2.46 million survivors and 34,307 decedents were analysed. The average annual healthcare costs were 2756 € for survivors and 21,830 € for decedents in the last year of life. The average healthcare costs for survivors increase with age whereas costs for decedents are highest in younger age groups and decline with increasing age. A detailed analysis of end-of-life costs shows an exponential increase of costs in the last three years of life with the highest costs in the quarter before death (10,577 €). DISCUSSION: The analysis gives a detailed overview on the structure of healthcare expenditure in the statutory health insurance and can serve as a basis for future forecasts regarding healthcare expenditure.

Evaluation of two family-based intervention programs for children affected by rare disease and their families - research network (CARE-FAM-NET): study protocol for a rater-blinded, randomized, controlled, multicenter trial in a 2x2 factorial design.

BACKGROUND: Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed. METHODS/DESIGN: The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents' as well as the children's perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. DISCUSSION: This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family's Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov : NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021.

Prescription of Benzodiazepines and Related Drugs in Patients with Mild Cognitive Deficits and Alzheimer's Disease.

INTRODUCTION: Benzodiazepines and related drugs (BZDR) should be avoided in patients with cognitive impairment. We evaluated the relationship between a BZDR treatment and the health status of patients with Alzheimer's disease (AD). METHODS: Cross-sectional study in 395 AD patients using bivariate and multiple logistic analyses to assess correlations between the prescription of BZDR and patients' characteristics (cognitive and functional capacity, health-related quality of life (HrQoL), neuropsychiatric symptoms). RESULTS: BZDR were used in 12.4% (n=49) of all participants. In bivariate analyses, the prescription was associated with a lower HrQoL, a higher need of care, and the presence of anxiety. Multivariate models revealed a higher risk of BZDR treatment in patients with depression (OR 3.85, 95% CI: 1.45 - 10.27). Community-dwelling participants and those treated by neurologists/psychiatrists had a lower risk of receiving BZDR (OR 0.33, 95% CI: 0.12 - 0.89 and OR 0.16, 95% CI: 0.07 - 0.36). DISCUSSION: The inappropriate use of BZDR conflicts with national and international guidelines. We suggest evaluating indications and treatment duration and improving the knowledge of alternative therapies in healthcare institutions.

Integrating patient perspectives in medical decision-making: a qualitative interview study examining potentials within the rare disease information exchange process in practice.

BACKGROUND: Many European countries have recently implemented national rare disease plans. Although the network is strengthening, especially on the macro and meso levels, patients still go a long way through healthcare systems, with many health professionals involved and scarce evidence to gather. Specifically, patient involvement in the form of shared decision-making can offer further potential to increase healthcare systems' efficiency on a micro level. Therefore, we examine the implementation of the shared decision-making concept thus far, and explore whether efficiency potentials exist-which are particularly relevant within the rare disease field-and how they can be triggered. METHODS: Our empirical evidence comes from 101 interviews conducted from March to September 2014 in Germany; 55 patients, 13 family members, and 33 health professionals participated in a qualitative interview study. Transcripts were analyzed using a directed qualitative content analysis. RESULTS: The interviews indicate that the decision-making process is increasingly relevant in practice. In comparison, however, the shared decision-making agreement itself was rarely reported. A majority of interactions are dominated by individual, informed decision-making, followed by paternalistic approaches. The patient-physician relationship was characterized by a distorted trust-building process, which is affected by not only dependencies due to the diseases' severity and chronic course, but an often-reported stigmatization of patients as stimulants. Moreover, participation was high due to a pronounced engagement of those affected, diminishing as patients' strength vanish during their odyssey through health care systems. The particular roles of "expert patients" or "lay experts" in the rare disease field were revealed, with further potential in integrating the gathered information. CONCLUSIONS: The study reveals the named efficiency potentials, which are unique for rare diseases and make the further integration of shared decision-making very attractive, facilitating diagnostics and disease management. It is noteworthy that integrating shared decision-making in the rare disease field does not only require strengthening the position of patients but also that of physicians. Efforts can be made to further integrate the concept within political frameworks to trigger the identified potential and assess the health-economic impact.

[Good Practice Data Linkage]. / Gute Praxis Datenlinkage (GPD).

Individual data linkage of different data sources for research purposes is being increasingly used in Germany in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to define such methodological standards for research projects. Another aim is to provide readers with a checklist for critical appraisal of research proposals and articles. Since 2016, an expert panel of members of different German scientific societies have worked together and developed 7 guidelines with a total of 27 practical recommendations. These recommendations include (1) research aims, questions, data sources and resources, (2) infrastructure and data flow, (3) data privacy, (4) ethics, (5) key variables and type of linkage, (6) data validation/quality assurance and (7) long-term use for future research questions. The authors provide a rationale for each recommendation. Future revisions will include any new developments in science and data privacy.

Costs of isocyanate-related occupational diseases: A systematic review.

Although isocyanates are increasingly used in manufacturing and workplace exposure to isocyanates is widely recognized as one of the most frequent causes for occupational lung and skin diseases, little is known about the economic burden on the affected individual and the society. This study provides an overview on costs of occupational diseases related to isocyanates. We performed a systematic literature search of studies in the electronic databases of the German Institute of Medical Documentation and Information, and the Canadian Centre for Occupational Health and Safety. We extracted the key characteristics of the studies and performed a study quality assessment. We identified eight studies on the costs of illness, of which five focused on occupational lung diseases and three on occupational skin diseases. Further, eight studies calculated loss of income/compensation payments. Out of the 16 identified articles, only two reported costs directly attributable to isocyanate-induced diseases (asthma). Studies were hardly comparable because they differed substantially in their methodological approaches. Moreover, the quality assessment of the studies revealed substantial limitations. While a wide range of isocyanate-related costs was identified, consequences of isocyanate-related occupational diseases were considerable in terms of societal costs and loss of income. In most studies, indirect costs were the main cost driver. There is a need for high-quality cost of illness studies on isocyanate-induced diseases stratified by degree of severity and sex. Such studies provide valuable information to develop preventive strategies and set priorities for measures to lower the burden of professional health risks.

Antidepressant medication in a German cohort of patients with Alzheimer's disease
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OBJECTIVE: The use of antidepressant drugs in dementia patients is associated with the risk of adverse events, and the evidence for relevant effects is scarce. We aimed to determine the associations between the prescription of antidepressants and patients' sociodemographic (e.g., age, gender, living situation) and clinical characteristics (e.g., disease severity, neuropsychiatric symptoms). MATERIALS AND METHODS: We included 395 institutionalized and community-dwelling patients with Alzheimer's disease (AD) across all severity stages of dementia in a cross-sectional study design. The patients' clinical characteristics comprised of cognitive status, daily activities, depressive symptoms, further neuropsychiatric symptoms, and health-related quality of life (HrQoL). We conducted multiple logistic regression analyses for the association between the use of antidepressant drugs and the covariates. RESULTS: Approximately 31% of the participants were treated with antidepressant drugs, with a higher chance of being medicated for institutionalized patients (χ2-test: p = 0.010). In the bivariate analyses, the use of antidepressants was significantly associated with higher levels of care, lower cognitive and daily life capacity, higher extent of neuropsychiatric symptoms, and a lower proxy-reported HrQoL. Finally, multiple logistic regression models showed a significantly higher use of antidepressants in patients treated by psychiatrists and neurologists (OR 2.852, 95% CI: 1.223 - 6.652). CONCLUSION: The use of antidepressant drugs in the study population was high, and the suitability of the treatment with antidepressants remains unclear. Participants with diminished cognitive and functional capacity, higher extent of neuropsychiatric symptoms, and those treated by neuropsychiatric specialists were more likely to be treated with antidepressants. The pharmaceutical treatment of patients with these clinical characteristics should be particularly considered in the daily care for dementia patients. Further longitudinal studies should evaluate the appropriateness of indications for antidepressants and the causative direction of correlations with the patients' clinical characteristics.
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[Quo Vadis Data Linkage in Germany? An Initial Inventory]. / Quo vadis Datenlinkage in Deutschland? Eine erste Bestandsaufnahme.

In recent years, linking different data sources, also called data linkage or record linkage, to address scientific questions, is being increasingly used in Germany. However, there are very few published reports and new projects develop the necessary tools independently of each other. Therefore, a team of researchers joined together to exchange their experiences on data linkage and to give suggestions on how linkage could be done for scientists, reviewers as well as members of data privacy boards and ethics committees. It is the aim of this article to assist future projects that want to link German data on an individual level. In addition to the legal framework conditions (data privacy), also examples of types of data linkage, their fields of application und potential pitfalls as well as the methods of preventing them will be described in an application-oriented fashion.

Antipsychotic treatment of community-dwelling and institutionalised patients with dementia in Germany.

OBJECTIVE: A restrictive use of antipsychotic drugs in patients with Alzheimer's disease (AD) is recommended due to an increased risk of cerebrovascular events and mortality. We hypothesise that the prescription of antipsychotics is associated with the patients' socio-demographic and clinical status (e.g., dementia severity). METHODS: The prescription of antipsychotics was cross-sectionally evaluated in 272 community-dwelling and 123 institutionalised patients with AD across all severity stages of dementia. The patients' clinical characteristics covered the cognitive status, neuropsychiatric symptoms, daily activities, and quality of life (HrQoL). To determine associations with the use of antipsychotics bivariate and logistic regression analyses were conducted. RESULTS: Totally, 25% of the patients were treated with antipsychotics. significantly less frequently than nursing home inhabitants (15.1% vs. 45.5%). Severely demented patients (MMSE 0-9) received antipsychotics most often (51.5%). Additionally, multiple regression analyses revealed a higher chance of prescription for participants with depressive symptoms (OR 2.3, 95% CI: 1.019-5.160) and those treated by neuropsychiatric specialists (OR 3.4, 95% CI: 1.408-8.328). CONCLUSIONS: Further longitudinal studies are required to assess the appropriateness of indications for antipsychotics and the reasons for a higher use in nursing home inhabitants and patients with severe dementia and depression.

Rare Diseases on the Internet: An Assessment of the Quality of Online Information.

BACKGROUND: The importance of the Internet as a medium for publishing and sharing health and medical information has increased considerably during the last decade. Nonetheless, comprehensive knowledge and information are scarce and difficult to find, especially for rare diseases. Additionally, the quality of health or medical information about rare diseases is frequently difficult to assess for the patients and their family members. OBJECTIVE: The aim of this study is to assess the quality of information on the Internet about rare diseases. Additionally, the study aims to evaluate if the quality of information on rare diseases varies between different information supplier categories. METHODS: A total of 13 quality criteria for websites providing medical information about rare diseases were transferred to a self-disclosure questionnaire. Identified providers of information on the Internet about rare diseases were invited to fill out the questionnaire. The questionnaire contained questions about the information provider in general (eg, supplier category, information category, language, use of quality certificates, and target group) and about quality aspects that reflect the 13 quality criteria. Differences in subgroup analyses were performed using t tests. RESULTS: We identified 693 websites containing information about rare diseases. A total of 123 questionnaires (17.7%) were completely filled out by the information suppliers. For the remaining identified suppliers (570/693, 82.3%), the questionnaires were filled out by the authors based on the information available on their website. In many cases, the quality of websites was proportionally low. Furthermore, subgroup analysis showed no statistically significant differences between the quality of information provided by support group/patient organization compared to medical institution (P=.19). The quality of information by individuals (patient/relative) was significantly lower compared to information provided by support group/patient organization (P=.001), medical institution (P=.009), and other associations and sponsoring bodies (P=.001) as well. CONCLUSIONS: Overall, the quality of information on the Internet about rare diseases is low. Quality certificates are rarely used and important quality criteria are often not fulfilled completely. Additionally, some information categories are underrepresented (eg, information about psychosocial counseling, social-legal advice, and family planning). Nevertheless, due to the high amount of information provided by support groups, this study shows that these are extremely valuable sources of information for patients suffering from a rare disease and their relatives.

[Central information portal on rare diseases : Implementation of quality- and needs-oriented information management]. / Zentrales Informationsportal über seltene Erkrankungen : Umsetzung eines qualitäts- und bedarfsorientierten Informationsmanagements.

BACKGROUND: A central information portal on rare diseases (ZIPSE) has been conceptualized and implemented that allows patients, relatives and health care professionals to access quality-assured information. For this purpose, quality criteria have been developed specifically for rare diseases. At the same time, the information basis should take into account the specific needs of those interested. OBJECTIVES: The needs of patients and relatives regarding online-based information are analyzed. Based on this, we examined to what extent the information basis, which is available according to the ZIPSE quality criteria, can cover these needs. If necessary, measures have to be developed to ensure quality- as well as needs-oriented information management. MATERIALS AND METHODS: Qualitative interviews with patients and relatives were conducted, which were then evaluated using content analysis. Subsequently, a quantitative evaluation of the information on rare diseases in the portal was made. The research addresses how many websites do not fulfil the quality criteria, from which group of provider these websites originate and which criteria are not fulfilled. This is followed by a comparison of the quantitative and qualitative results. RESULTS AND CONCLUSIONS: When looking for information on the Internet, the websites of self-help groups represent a significant source. These are perceived as very trustworthy and in the later course of the disease, offer detailed information on important information areas. Information websites from self-help groups, however, often do not meet quality requirements. Therefore, a transparent representation is made regarding the quality of the ZIPSE information pages. Pages that are not quality-assured can be actively requested, but will be clearly identified.