The Role of Vaccination Centers in a National Mass Immunization Campaign-Policymaker Insights from the German COVID-19 Pandemic Vaccine Roll-Out.

During the COVID-19 vaccination campaign, Germany, like other high-income countries, introduced mass vaccination centers for administering vaccinations. This qualitative study aimed to examine the role that these novel, temporary government healthcare structures played in a mass immunization roll-out and how they can be optimally deployed. In addition, learnings for general emergency preparedness were explored. A total of 27 high-level policymakers responsible for planning and implementing the COVID vaccination campaign at the national and state level in Germany were interviewed in May and June 2022. The semi-structured interviews were analyzed using thematic analysis. Interviewees indicated that mass vaccination structures played an essential role with respect to controllability, throughput, accessibility and openness in line with the key success criteria vaccination coverage, speed and accessibility. In contrast to the regular vaccination structures (private medical practices and occupational health services), public administration has direct authority over mass vaccination centers, allowing for reliable vaccine access prioritization and documentation. The deployment of vaccination centers should be guided by vaccine availability and demand, and vaccine requirements related to logistics, as well as local capacities, i.e., public-health-service strength and the physician density, to ensure effective, timely and equitable access. Improvements to the capacity use, scalability and flexibility of governmental vaccination structures are warranted for future pandemics.

[Barriers to Digitalisation of Healthcare in Germany: A Survey of Experts]. / Hürden bei der Digitalisierung der Medizin in Deutschland ­ eine Expertenbefragung.

BACKGROUND: Digital health is a growing area in healthcare with a huge potential. Nevertheless, the degree of digitalization in German healthcare is low when compared internationally and with other German industries. Despite political efforts, certain barriers seem to strongly impede the process of digitalization process in healthcare. METHOD: We surveyed 18 representative healthcare experts from various sectors with semi-structured interviews on barriers and solutions for digital health. Thematic analysis by Braun and Clarke was used for interpretation. RESULTS: The interviewees identified barriers that were stakeholder-specific and across stakeholders. Self-regulatory bodies and the medical profession were found to lack willingness and organizational structure for digitalization. Lack of evidence and missing interoperability represented primary obstacles, while current legislation and financial regulations were rarely mentioned. In particular, infrastructure expansion and interoperability would require a coordinated, state intervention. Positive communication on possibilities and benefits of digital solutions was also considered important. CONCLUSION: A strong political will, an overarching strategy accompanied by a communication concept seems to be necessary in order for digital health to succeed. Regarding legislation, binding specifications, deadlines and sanctions may be needed for self-regulatory bodies, while also involving users in the development process at an early stage and creating positive incentives for using digital solutions.

Health-economic evaluation of home telemonitoring for COPD in Germany: evidence from a large population-based cohort.

INTRODUCTION: Telemonitoring for COPD has gained much attention thanks to its potential of reducing morbidity and mortality, healthcare utilisation and costs. However, its benefit with regard to clinical and economic outcomes remains to be clearly demonstrated. OBJECTIVE: To analyse the effect of Europe's largest COPD telemonitoring pilot project on direct medical costs, health resource utilisation and mortality at 12 months. METHODS: We evaluated a population-based cohort using administrative data. Difference-in-difference estimators were calculated to account for time-invariant unobservable heterogeneity after removing dissimilarities in observable characteristics between the telemonitoring and control group with a reweighting algorithm. RESULTS: The analysis comprised 651 telemonitoring participants and 7047 individuals in the standard care group. The mortality hazards ratio was lower in the intervention arm (HR 0.51, 95 % CI 0.30-0.86). Telemonitoring cut total costs by 895 € (p < 0.05) compared to COPD standard care, mainly driven by savings in COPD-related hospitalisations in (very) severe COPD patients (-1056 €, p < 0.0001). Telemonitoring enrolees used healthcare (all-cause and COPD-related) less intensely with shorter hospital stays, fewer inpatient stays and smaller proportions of people with emergency department visits and hospitalisations (all p < 0.0001). Reductions in mortality, costs and healthcare utilisation were greater for (very) severe COPD cases. CONCLUSION: This is the first German study to demonstrate that telemonitoring for COPD is a viable strategy to reduce mortality, healthcare costs and utilisation at 12 months. Contrary to widespread fear, reducing the intensity of care does not seem to impact unfavourably on health outcomes. The evidence offers strong support for introducing telemonitoring as a component of case management.

Cholesterol- and blood-pressure-lowering drug use for secondary cardiovascular prevention in 2004-2013 Europe.

Background Suboptimal use of cardiovascular prevention medications has been reported. We report recent trends in secondary cardiovascular disease prevention drug use in Europe. Design We used the 2004-2013 data from the Survey of Health, Ageing and Retirement in Europe (SHARE), a large longitudinal cohort study in middle-aged and elderly Europeans. Methods Cross-sectional and panel data logistic regression models were used to study trends in cholesterol- and blood pressure-lowering drug use and effects of participant characteristics on the likelihood of drug use among participants with histoty of cardiovascular disease in SHARE. Results In SHARE 21,388 participants reported history of cardiovascular disease and provided data on cholesterol- and blood pressure-lowering drug use. At initial report, 40% and 60% of them used cholesterol- or blood pressure-lowering drugs, respectively. Increasing cross-sectional time trends were observed for both medication classes (odds ratios of use in 2013 vs. 2004, 1.6 (95% confidence interval 1.4-1.7) and 1.5 (1.4-1.6), respectively). However, among participants with multiple observations, the use of both classes declined over time (2013 vs. 2004 odds ratio 0.63 (0.51-0.77) and 0.68 (0.55-0.84), respectively; both trend p < 0.001), and with increasing duration since last cardiovascular event (odds ratio 0.74 (0.60-0.91), trend p = 0.01 and odds ratio 0.82 (0.66-1.03), trend p = 0.06, respectively for durations of nine years or more versus less than one year). Among people with history of cardiovascular disease, those obese, retired or with hypercholesterolaemia, hypertension, worse self-perceived health, and, in the case of lipid-lowering medication, with diabetes, were more likely to use these medications. Conclusions Despite moderately increasing cross-sectional time trends, the use of secondary cardiovascular disease prevention drugs remains low in Europe with substantial discontinuation over time and with increasing duration from an acute cardiovascular event.

Cost-Utility Analysis of Telemonitoring Interventions for Patients with Chronic Obstructive Pulmonary Disease (COPD) in Germany.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) poses major challenges for health care systems. Previous studies suggest that telemonitoring could be effective in preventing hospitalisations and hence reduce costs. OBJECTIVE: The aim was to evaluate whether telemonitoring interventions for COPD are cost-effective from the perspective of German statutory sickness funds. METHODS: A cost-utility analysis was conducted using a combination of a Markov model and a decision tree. Telemonitoring as add-on to standard treatment was compared with standard treatment alone. The model consisted of four transition stages to account for COPD severity, and a terminal stage for death. Within each cycle, the frequency of exacerbations as well as outcomes for 2015 costs and quality adjusted life years (QALYs) for each stage were calculated. Values for input parameters were taken from the literature. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: In the base case, telemonitoring led to an increase in incremental costs (€866 per patient) but also in incremental QALYs (0.05 per patient). The incremental cost-effectiveness ratio (ICER) was thus €17,410 per QALY gained. A deterministic sensitivity analysis showed that hospitalisation rate and costs for telemonitoring equipment greatly affected results. The probabilistic ICER averaged €34,432 per QALY (95 % confidence interval 12,161-56,703). CONCLUSION: We provide evidence that telemonitoring may be cost-effective in Germany from a payer's point of view. This holds even after deterministic and probabilistic sensitivity analyses.

Costs and outcomes of the German disease management programme (DMP) for chronic obstructive pulmonary disease (COPD)-A large population-based cohort study.

INTRODUCTION: To curb costs and improve health outcomes in chronic obstructive pulmonary disease (COPD), a nationwide disease management programme (DMP) was introduced in Germany in 2005. Yet, its effectiveness has not been comprehensively evaluated. OBJECTIVE: To examine the effects of the German COPD DMP over three years on costs and health resource utilisation from the payer perspective, process quality, morbidity and mortality. METHODS: A retrospective, population-based cohort study design is applied, using administrative data. After eliminating differences in observable characteristics between the DMP and the control group with entropy balancing, difference-in-difference estimators were computed to account for time-invariant unobservable heterogeneity. RESULTS: 215,104 individuals were included into the analysis of whom 25,269 were enrolled in the DMP. DMP patients had a reduced mortality hazard ratio (0.89, 95%CI: 0.84-0.94) but incurred excess costs of €553 per year. DMP enrolees reveal higher healthcare utilisation with larger shares of individuals being hospitalised (3.14%), consulting an outpatient clinic due to exacerbations (11.13%) and pharmaceutical prescriptions (2.78). However, average length of hospitalisation due to COPD fell by 0.49 days, adherence to medication guidelines as well as indicators for morbidity improved. CONCLUSION: The German COPD DMP achieved significant improvements in mortality, morbidity and process quality, but at higher costs. Given the low ICER per life year gained, DMP COPD may constitute a cost-effective option to promote COPD population health.

Systematic review and meta-analysis of the prevalence of resistant hypertension in treated hypertensive populations.

BACKGROUND: Although treatment-resistant hypertension (RH) is a serious burden on population health, there exists uncertainty about its prevalence. Hence, the objectives of this work were to systematically review and critically appraise the literature and to conduct a meta-analysis on the prevalence of RH in treated hypertensive populations. METHODS: PubMed, Cochrane Library, CRD York databases, and study bibliographies were systematically searched for observational and interventional studies that report disease frequency in adult populations. The pooled prevalence was obtained through random-effect modeling. Furthermore, quality assessment, publication bias diagnostics, meta-regression, subgroup analysis by sex, and sensitivity analysis were performed. RESULTS: Out of 318 retrieved studies, 20 observational studies and 4 randomized control trials (RCTs) with a total population of 961,035 were included. The random-effect method for observational studies and RCTs yielded RH prevalence ratios of 13.72% (95% confidence interval (CI) = 11.19%-16.24%) and 16.32% (95% CI = 10.68%-21.95%), respectively. Yet, most studies were incapable of ruling out pseudo-resistance caused by white-coat effect, poor medication adherence, and suboptimal dosing. Differences in RH prevalence by sex were negligible. Meta-regression analysis showed that study-level characteristics had no statistically significant influence on RH prevalence. The inclusion of further studies in the sensitivity analysis concurred with the baseline results (13.19%; 95% CI = 10.89%-15.49%). CONCLUSIONS: Researchers should enhance comparability of future empirical evidence through homogeneous methodologies and comparable baseline populations. This meta-analysis concludes that RH is a frequent phenomenon and further harmonization in terms of RH definition and measurement would be necessary to clearly distinguish true treatment resistance from pseudo-resistance.

The economic impact of Marfan syndrome: a non-experimental, retrospective, population-based matched cohort study.

BACKGROUND: Marfan syndrome is a rare disease of the connective tissues, affecting multiple organ systems. Elevated morbidity and mortality in these patients raises the issue of costs for sickness funds and society. To date, there has been no study analysing the costs of Marfan syndrome from a sickness fund and societal perspective. OBJECTIVE: To estimate excess health resource utilisation, direct (non-)medical and indirect costs attributable to Marfan syndrome from a healthcare payer and a societal perspective in Germany in 2008. METHODS: A retrospective matched cohort study design is applied, using claims data. For isolating the causal effect of Marfan syndrome on excess costs, a genetic matching algorithm was used to reduce differences in observable characteristics between Marfan syndrome patients and the control group. 892 patients diagnosed with Marfan syndrome (ICD-10 Q87.4) were matched from a pool of 26,645 control individuals. After matching, we compared health resource utilisation and costs. RESULTS: From the sickness fund perspective, an average Marfan syndrome patient generates excess annual costs of €2496 compared with a control individual. From the societal perspective, excess annual costs amount to €15,728. For the sickness fund, the strongest cost drivers are inpatient treatment and care by non-physicians. From the sickness fund perspective, the third (25-41 years) and first (0-16 years) age quartiles reveal the greatest surplus in total costs. Marfan syndrome patients have 39% more physician contacts, a 153% longer average length of hospital stay, 119% more inpatient stays, 33% more prescriptions, 236% more medical imaging and 20% higher average prescription costs than control individuals. Depending on the prevalence, the economic impact from the sickness fund perspective ranges between €24.0 million and €61.4 million, whereas the societal economic impact extends from €151.3 million to €386.9 million. CONCLUSIONS: Relative to its low frequency, Marfan syndrome requires high healthcare expenditure. Not only the high costs of Marfan syndrome but also its burden on patients' lives call for more awareness from policy-makers, physicians and clinical researchers. Consequently, the diagnosis and treatment of Marfan syndrome should begin as soon as possible in order to prevent disease complications, early mortality and substantial healthcare expenditure.

Policy expectations and reality of telemedicine - a critical analysis of health care outcomes, costs and acceptance for congestive heart failure.

A critical review of evidence was carried out to discover whether the actual performance of telemedicine fulfils the expectations of German policy-makers. The analysis was conducted using the example of telemedicine for congestive heart failure (CHF). It was based on both German and international evidence. The PubMed, MEDLINE, Google Scholar and Cochrane Library databases were searched, as well as public sources from the German Federal Ministry of Health. Forty-five studies reporting patient outcomes, costs or acceptance of telemedicine for CHF were included in the review, of which 28 were interventional. The policy expectations of telemedicine generally are: high technology acceptance and improved patient outcomes at lower costs. However, in the field of CHF, policy-makers underestimate the complexity of telemedicine and the technology has not yet lived up to its expectations. Although some studies show improvements in all-cause mortality and CHF-related hospitalisations, there is excessive study heterogeneity and vagueness in the areas of costs and acceptance. Methodological insufficiencies as well as the scarcity of evidence in the German context do not allow definite conclusions to be drawn. Policy-makers and other stakeholders should increase their efforts to consolidate isolated telemedicine projects, establish guidelines for clinical treatment procedures and economic evaluations, and define industry/technical device standards to enhance the comparability of interventions. Imposing the use of telemedicine on patients and physicians is not likely to be fruitful. A successful adaptation requires an analysis of needs and continuous education on both sides.

Cost-utility analysis comparing heavy-weight and light-weight mesh in laparoscopic surgery for unilateral inguinal hernias.

BACKGROUND: Hernioplasty is one of the most frequent surgeries in the UK. Light-weight mesh (LWM) has the potential to reduce chronic groin pain but its cost-effectiveness compared with heavy-weight mesh (HWM) is unknown. OBJECTIVE: Our objective was to conduct a cost-utility analysis between laparoscopic hernioplasty with HWM and LWM for unilateral inguinal hernias. METHODS: A Markov model simulated costs and health outcomes over a period of 1 year (2012) from the societal and National Health Service (NHS) perspective (England). The main outcome was cost per quality-adjusted life-year (QALY) gained. Surgery results were gleaned from the randomized control trial by Bittner et al. Other input parameters were drawn from the literature and public sources of the NHS. RESULTS: From the societal perspective, LWM induces lower incremental costs (-£88.85) than HWM but yields a slightly smaller incremental effect (-0.00094 QALYs). The deterministic incremental cost-effectiveness ratio (ICER) for HWM compared with LWM amounts to £94,899 per QALY, while the probabilistic ICER is £118,750 (95 % confidence interval [CI] £57,603-180,920). Owing to the withdrawal of productivity losses from the NHS perspective, LWM causes higher incremental costs (£13.09) and an inferior incremental effect (-0.00093), resulting in a dominance of HWM over LWM (ICER 95 % CI -£12,382 to -£21,590). CONCLUSIONS: There is no support for the adoption of LWM as standard treatment from an NHS perspective. However, given the small differences between HWM and LWM, LWM has at least the potential of improving patient outcomes and reducing expenditure from the societal perspective.