Dimensions of health data Integrity.

Health data integrity, as an emergent concept, stands to reshape the lifecycle of data-driven healthcare and research, ensuring a shared commitment to ethical practices and improved patient care.

Effects of Life Events and Social Isolation on Stroke and Coronary Heart Disease.

The current coronavirus disease 2019 (COVID-19) pandemic represents a severe, life-changing event for people across the world. Life changes may involve job loss, income reduction due to furlough, death of a beloved one, or social stress due to life habit changes. Many people suffer from social isolation due to lockdown or physical distancing, especially those living alone and without family. This article reviews the association of life events and social isolation with cardiovascular disease, assembling the current state of knowledge for stroke and coronary heart disease. Possible mechanisms underlying the links between life events, social isolation, and cardiovascular disease are outlined. Furthermore, groups with increased vulnerability for cardiovascular disease following life events and social isolation are identified, and clinical implications of results are presented.

Ankle-brachial index predicts stroke in the general population in addition to classical risk factors.

BACKGROUND: Predictors of future stroke events gain importance in vascular medicine. Herein, we investigated the value of the ankle-brachial index (ABI), a simple non-invasive marker of atherosclerosis, as stroke predictor in addition to established risk factors that are part of the Framingham risk score (FRS). METHODS: 4299 subjects from the population-based Heinz Nixdorf Recall study (45-75 years; 47.3% men) without previous stroke, coronary heart disease or myocardial infarcts were followed up for ischemic and hemorrhagic stroke events over 109.0±23.3 months. Cox proportional hazard regressions were used to evaluate ABI as stroke predictor in addition to established vascular risk factors (age, sex, systolic blood pressure, LDL, HDL, diabetes, smoking). RESULTS: 104 incident strokes (93 ischemic) occurred (incidence rate: 2.69/1000 person-years). Subjects suffering stroke had significantly lower ABI values at baseline than the remaining subjects (1.03±0.22 vs. 1.13±0.14, p<0.001). In a multivariable Cox regression, ABI predicted stroke in addition to classical risk factors (hazard ratio=0.77 per 0.1, 95% confidence interval=0.69-0.86). ABI predicted stroke events in subjects above and below 65 years, both in men and women. ABI specifically influenced stroke risk in subjects belonging to the highest (>13%) and intermediate (8-13%) FRS tercile. In these subjects, stroke incidence was 28.13 and 8.13/1000 person-years, respectively, for ABI<0.9, compared with 3.97 and 2.07/1000 person-years for 0.9≤ABI≤1.3. CONCLUSIONS: ABI predicts stroke in the general population, specifically in subjects with classical risk factors, where ABI identifies subjects at particularly high stroke risk.

German diabetes management programs improve quality of care and curb costs.

This paper reports the results of a large-scale analysis of a nationwide disease management program in Germany for patients with diabetes mellitus. The German program differs markedly from "classic" disease management in the United States. Although it combines important hallmarks of vendor-based disease management and the Chronic Care Model, the German program is based in primary care practices and carried out by physicians, and it draws on their personal relationships with patients to promote adherence to treatment goals and self-management. After four years of follow-up, overall mortality for patients and drug and hospital costs were all significantly lower for patients who participated in the program compared to other insured patients with similar health profiles who were not in the program. These results suggest that the German disease management program is a successful strategy for improving chronic illness care.

Uncertainty assessment of input parameters for economic evaluation: Gauss's error propagation, an alternative to established methods.

In decision modeling for health economic evaluation, bootstrapping and the Cholesky decomposition method are frequently used to assess parameter uncertainty and to support probabilistic sensitivity analysis. An alternative, Gauss's error propagation law, is rarely known but may be useful in some settings. Bootstrapping, the Cholesky decomposition method, and the error propagation law were compared regarding standard deviation estimates of a hypothetic parameter, which was derived from a regression model fitted to simulated data. Furthermore, to demonstrate its value, the error propagation law was applied to German administrative claims data. All 3 methods yielded almost identical estimates of the standard deviation of the target parameter. The error propagation law was much faster than the other 2 alternatives. Furthermore, it succeeded the claims data example, a case in which the established methods failed. In conclusion, the error propagation law is a useful extension of parameter uncertainty assessment.

The German Coronary Artery Disease Risk Screening Model: development, validation, and application of a decision-analytic model for coronary artery disease prevention with statins.

BACKGROUND: Coronary artery disease (CAD) is a major cause of death in industrial countries, leading to high health-related costs and decreased quality of life. OBJECTIVE: To develop and validate a decision-analytic model for CAD risk screening in Germany (German Coronary Artery Disease Screening Model). DESIGN: Markov model. TARGET POPULATION: Age- and gender-specific cohorts of the German population. DATA SOURCES: Mortality rates posted by the German Federal Statistical Office, the German Health Survey, social health insurance institutions, the MONICA Augsburg study, and the literature. TIME HORIZON: Lifetime. INTERVENTIONS: CAD risk screening for high-risk individuals using Framingham risk equation and use of statins as the primary preventive measure, compared with a setting without screening. OUTCOME MEASURES: Life-years (LY) gained, quality-adjusted life-years (QALYs) gained. RESULTS: The model-based CAD incidence corresponds well with empirical data from the MONICA Augsburg study. Health outcomes depend on the screening threshold (cutoff value of Framingham 10-year risk) and on the age and gender of the cohort screened (0.03 to 0.26 LYs and 0.06 to 0.42 QALYs gained per person screened in cohorts of 50- and 60-year-old men and women, respectively). CONCLUSIONS: The model provides a valid tool for evaluating the long-term effectiveness of CAD risk screening in Germany. Using statins as a primary prevention intervention for CAD in high-risk individuals identified by screening could improve the long-term health of the German population.

[The influence of quality management on job satisfaction and work load--exemplary study in a German hospital]. / Wie wirkt sich die Einführung des Qualitätsmanagements auf die Arbeitszufriedenheit und Arbeitsbelastung aus? Exemplarische Untersuchung in einer Klinik.

Surveys among employees are getting more and more relevant in hospital settings since an increase in both (1) efficiency and (2) quality in connection with (3) enhanced patient orientation will only be achieved, if at the same time the employees' health status and satisfaction are taken into account. Thus, the objective of this study was to compare the satisfaction of employees in a single hospital enquired in 2002 with that of 2005. Particular consideration was given to their view of quality management. Is there a correlation between employees' satisfaction, their degree of information on quality management, and their assessment of quality management? In the survey of 2005 employees were more satisfied with their work and their working conditions than in the previous inquiry conducted in 2002. They felt less mental stress, despite the declining length of hospitalisation combined with a higher turnover of in-hospital cases and with lower numbers of full-time staff. The employees' satisfaction, however, differed widely among the three departments with regard to the items "involvement with decisions" and "support by the superiors". The overall assessment of quality management is positive. Specific items such as the assessment of the management's commitment to quality management were strongly influenced by the employees' degree of information on quality management, which varies between departments. In the department with the lowest work satisfaction quality management was attributed a high potential for change and improvement. After quality management will have been implemented throughout the hospital, a new survey should be undertaken to evaluate whether quality management affects the employees' satisfaction with their work.

[Does the lack of evidence of effectiveness among international studies on interventions in prevention and health promotion have an impact on a German Act of Prevention?]. / Evidenz der Wirksamkeit internationaler Präventionsmassnahmen und Auswirkungen auf ein deutsches Präventionsgesetz.

BACKGROUND AND PURPOSE: Efforts have been undertaken to devise and pass an Act of Prevention in Germany. To date, no consensus could be reached with changing political majorities in parliament. Hence, the authors ask the question whether the lack of evidence in prevention and health promotion could also be contributing to this delay. METHODS: After a systematic search of the literature on prevention and health promotion in nutrition, exercise, depression, and smoking, all retrieved studies were evaluated in terms of their effect as well as the quality of study design like prior power calculation and intervention like documentation of process or participation of intended group. For inclusion, studies had to be undertaken in one of 13 countries that have a socioeconomic standard of living comparable to Germany. The authors of this article exemplarily included studies from the following focus areas into the systematic review: prevention of depression among children and adolescents, exercise in the work environment, nutrition for children and adolescents, and smoking cessation programs among pregnant women, all from 1990 to 2006. RESULTS: The authors retrieved 18 studies on prevention of depression among children and adolescents, 26 on exercise in the work environment, 23 on nutrition for children and adolescents, and 34 on smoking cessation programs among pregnant women. Six out of 26 on exercise had a positive effect (23.1%), one out of 18 on depression (5.6%), seven out of 23 in the field of nutrition (30.4%), and nine out of 34 smoking cessation programs (26.5%). If one takes into account the quality of study design and intervention as a marker for the reliability and validity of results, one intervention on exercise, two on nutrition, three on smoking and none on depression would remain with a positive effect. CONCLUSION: In four exemplarily selected fields only six out of a total of 101 international studies (5.9%) had an effect, if one also ties in quality of study design and intervention. With regard to this result, allocation of resources for prevention and health promotion would be highly ambiguous without sufficient evidence. This condition might contribute to the deferment of an Act of Prevention in the German legislation. For the future, the authors strongly urge that the Act of Prevention takes into account the evaluation both of effects and quality of any intervention in order to prevent false allocation of resources.

Quantification and classification of errors associated with hand-repackaging of medications in long-term care facilities in Germany.

OBJECTIVE: The aim of this study was to quantify and classify errors associated with the repackaging of residents' medications in long-term care facilities in Germany. METHODS: This was a prospective 8-week study conducted in 3 long-term care facilities. Pill organizers, each of which contained all repackaged solid oral dosage forms of long-term medications for a particular resident for an entire day, were inspected and checked against residents' medication sheets by the investigator-pharmacist. On agreement between the pharmacist and the registered nurse responsible for residents' medications, all errors were rectified before medications were administered. The primary study measure was the overall rate of incorrectly repackaged medications relative to all repackaged medications. Secondary measures were the proportion of all pill organizers with medication errors and the proportion of residents who would have been affected by these errors. Errors were categorized by type as follows: wrong time of administration, wrong dose, wrong medication, omission of a medication, extra dose, incorrect halving of tablets, and damaged medication. RESULTS: One hundred ninety-six residents were included in the study, representing 8798 daily pill organizers and 48,512 inspected medications. Residents received a mean of 5.4 solid oral dosage forms of long-term medications per day. Six hundred forty-five errors were detected, for an error rate of 1.3%; the errors involved 7.3% of daily pill organizers and 53.0% of residents. The largest proportion of errors involved incorrect halving of tablets (49.1%), followed by omission of a medication (22.0%), extra dose (9.8%), wrong time of administration (8.4%), damaged medication (6.4%), wrong dose (4.2%), and wrong medication (0.2%). These results may underestimate true rates of repackaging errors across long-term care facilities in Germany, as the conditions in the 3 facilities in this study were near-optimal in terms of the environment, process, and quality of repackaging. CONCLUSIONS: Among 48,512 medications inspected over 8 weeks in 3 German long-term care facilities, the rate of repackaging errors was 1.3%, involving 7.3% of daily pill organizers and the medications of 53.00% of residents. The largest proportion of errors involved incorrect halving of tablets.

Preliminary analysis of short-term financial implications of a prevention bonus program: first results from the German Statutory Health Insurance.

OBJECTIVES: With the implementation of the Health Care Modernization Act in 2004 sickness funds in Germany were given the opportunity to award bonuses to their insured for health-promoting behavior. The aim of this study was to investigate the financial implications of a prevention bonus program from a sickness fund perspective. METHOD: The investigation was designed as a controlled cohort study (matched pair study) comprising 70,429 members in each group. Matching criteria were sex, postal code, insurance status, and cost categories for health care utilization. Insured opted into the program on a voluntary basis. The program consisted of interventions featuring primary prevention, modest exercise and immunization. Differences in cost trends between the two groups were examined using the paired t-test. RESULTS: A reduction in mean costs of 241.11 Euro per active member for the year 2005 (90% CI = 348.70, 133.52; p-value < 0.001) could be achieved in the intervention group compared to the control group. When costs for the implementation of the program and the bonus payments were taken into account, there was a saving of 97.14 Euro per active member for the year 2005. CONCLUSIONS: Preliminary results of a prevention bonus program in the German Statutory Health Insurance suggest a decrease in mean health care spending per enrollee. These effects may increase with time as long term effects of prevention become effective. However, further research is needed to understand how much of these short-term cost reductions can be attributed to the program itself rather than to possible confounders or volunteer bias and how the short-term savings may be accrued.

[Efficiency of computer-based documentation in long-term care--preliminary project]. / Effizienz der computergestültzten Dokumentation in Pflegeheimen--eine Pilotstudie.

In Germany the documentation of processes in long-term care is mainly paper-based. Planning, realization and evaluation are not supported in an optimal way. In a preliminary study we evaluated the consequences of the introduction of a computer-based documentation system using handheld devices. We interviewed 16 persons before and after introducing the computer-based documentation and assessed costs for the documentation process and administration. The results show that reducing costs is likely. The job satisfaction of the personnel increased, more time could be spent for caring for the residents. We suggest further research to reach conclusive results.

Sex differences in treatment patterns of six chronic diseases: an analysis from the German statutory health insurance.

OBJECTIVE: The goal of this study was to investigate gender-specific differences in prevalence, healthcare costs, and treatment patterns in the German Statutory Health Insurance (SHI). METHODS: The study analyzed administrative claims data of over 26 million insured with respect to prevalence and cost of illness of six chronic diseases. Insured were identified using the ATC code for medication prescription and ICD-9 code for diagnosis. The influences of gender, age, and comorbidity on cost differences were analyzed via multivariate regression analysis. RESULTS: Adjusted for age and comorbidity, gender had a significant influence on both hospital and medication spending. Hospital costs on average were 17.1% (95% CI 14.1; 20.2) higher for men compared with women. Medication spending for men exceeded that for women on average by 13.8% (95% CI 10.9; 16.7). The diagnoses with the highest prevalence were hypertension and heart failure. Women had a higher prevalence of diabetes, coronary artery disease (CAD), heart failure, and hypertension. Medication costs were higher for men in three of five diagnoses and comparable for two diagnoses (diabetes and asthma). Women received more medication prescriptions than men, but on average prescriptions for men were 14%-26% more expensive than prescriptions for women. Regarding treatment patterns men were treated with different drug classes in cardiovascular disease (CVD) compared with women. Total medication spending stratified by diagnosis was highest for diabetes. CONCLUSIONS: Gender differences for costs and prescribing patterns for chronic diseases vary disease specifically, but generally men had higher inpatient costs and more expensive medication prescriptions, whereas women had higher numbers of prescriptions.

Waiting times for elective treatments according to insurance status: A randomized empirical study in Germany.

BACKGROUND: Health insurance coverage for all citizens is often considered a requisite for reducing disparities in health care accessibility. In Germany, health insurees are covered either by statutory health insurance (SHI) or private health insurance (PHI). Due to a 20%-35% higher reimbursement of physicians for patients with PHI, it is often claimed that patients with SHI are faced with longer waiting times when it comes to obtaining outpatient appointments. There is little empirical evidence regarding outpatient waiting times for patients with different health insurance status in Germany. METHODS: We called 189 specialist practices in the region of Cologne, Leverkusen, and Bonn. Practices were selected from publicly available telephone directories (Yellow Pages 2006/2007) for the specified region. Data were collected for all practices within each of five specialist fields. We requested an appointment for one of five different elective treatments (allergy test plus pulmonary function test, pupil dilation, gastroscopy, hearing test, MRT of the knee) by calling selected practices. The caller was randomly assigned the status of private or statutory health insuree. The total period of data collection amounted to 4.5 weeks in April and May 2006. RESULTS: Between 41.7% and 100% of the practices called were included according to specialist field. We excluded practices that did not offer the requested treatment, were closed for more than one week, did not answer the call, did not offer fixed appointments ("open consultation hour") or did not accept any newly registered patients. Waiting time difference between private and statutory policyholders was 17.6 working days (SHI 26.0; PHI 8.4) for allergy test plus pulmonary function test; 17.0 (25.2; 8.2) for pupil dilation; 24.8 (36.7; 11.9) for gastroscopy; 4.6 (6.8; 2.2) for hearing test and 9.5 (14.1; 4.6) for the MRT of the knee. In relative terms, the difference in working days amounted to 3.08 (95%-KI: 1,88 bis 5,04) and proved significant. CONCLUSION: Even with comprehensive health insurance coverage for almost 100% of the population, Germany shows clear differences in access to care, with SHI patients waiting 3.08 times longer for an appointment than PHI patients. Wide-spread anecdotal reports of shorter waiting times for PHI patients were empirically supported. Discrepancies in access to care not only depend on accessibility to comprehensive health insurance cover, but also on the level of reimbursement for the physician. Higher reimbursements for the provider when it comes to comparable health problems and diagnostic treatments could lead to improved access to care. We conclude that incentives for adjusting access to care according to the necessity of treatment should be implemented.

Can evidence-based medicine implicitly rely on current concepts of disease or does it have to develop its own definition?

Decisions in healthcare are made against the background of cultural and philosophical definitions of disease, sickness and illness. These concepts or definitions affect both health policy (macro level) and research (meso level), as well as individual encounters between patients and physicians (micro level). It is therefore necessary for evidence-based medicine to consider whether any of the definitions underlying research prior to the hierarchisation of knowledge are indeed compatible with its own epistemological principles.

Disease management and health care reforms in Germany - does more competition lead to less solidarity?

Up to the 1990s German health care legislation was dominated by measures regulating the supply side. Measures, such as budgets, aimed at volume control and sought to confine the increase of health care spending to the growth of the national income. To curb costs more effectively, competitive elements were introduced in the 1990s with free choice of sickness funds (open enrollment). To balance competition and solidarity, a risk compensation scheme (RCS) was implemented two years prior to open enrollment. Since then, balancing competition and solidarity has been a key feature of all consecutive health care reforms. The implementation of disease management programs in the statutory health insurance (SHI) served the dual purpose to promote quality of care and to foster competition. Preliminary experiences suggest, that the aligning of disease management programs with a RCS can greatly aid its implementation and benefit solidarity and competition.

Prevalence of anti-erythropoietin antibodies in hemodialysis patients without clinical signs of pure red cell aplasia. Comparison between hypo- and normoresponsive patients treated with epoetins for renal anemia.

BACKGROUND/AIMS: The prevalence of anti-erythropoietin antibodies in renal patients without clinical evidence of pure red cell aplasia (PRCA) who respond poorly to epoetin is unknown. This study tested for anti-erythropoietin antibodies in hemodialysis patients who were either hypo- or normoresponsive to epoetin treatment. METHODS: Epoetin hyporesponsiveness (hemoglobin < or =10.5 g/dl and epoetin > or =9,000 IU/week) and normoresponsiveness (hemoglobin >10.5 g/dl and epoetin <7,000 IU/week) were arbitrarily defined. Prevalence of anti-erythropoietin antibodies in hemodialysis patients without symptoms of PRCA was determined by screening sera of 536 patients from 35 German KfH dialysis units, using enzyme-linked immunosorbent assay (ELISA). Positive results were verified by radioimmunoprecipitation assay (RIP) and neutralizing activity was determined by bioassay. RESULTS: Anti-erythropoietin antibodies were detected in 3 hyporesponsive and 3 normoresponsive patients using ELISA. One patient per group was verified as borderline by RIP testing; the other 4 were negative. The bioassay was negative for 1 patient; the other died unrelated to PRCA before testing. Follow-up with RIP testing after 15 months under continuous epoetin treatment was negative (4 patients, 2 deceased). CONCLUSION: This survey did not identify anti-erythropoietin antibodies in hemodialysis patient's hyporesponsive to epoetin and does not support presumptive antibody screening as a routine work-up in these patients.