[Emergency care: need for reform from an outpatient perspective]. / Notfallversorgung ­ Reformbedarf aus ambulanter Sicht.

Reforms of emergency and after hours care have been on the health policy agenda for years, and continue to remain there in the present government's program. In order to outline where this originates from, we provide a brief summary of past reform steps and a claims data analysis of ambulatory and inpatient emergency and after hours care. Given that previous reform steps have been triggered by increases in emergency department utilization by low acuity cases that could have been treated by office-based physicians during office hours or in after hours care, we analyze the ambulatory and inpatient claims data in the past decade prior to the pandemic (2010-2019). The result shows increases until 2015. Thereafter, the overall case load in emergency wards has levelled, while outpatient cases in emergency wards have decreased. This effect cannot safely be attributed to elements of demand management such as after hours practices in hospitals and telephone triage that have been implemented since then. The distribution of diagnostic codes in claims data suggests that emergency wards and after hours practices have reached a clear division of labor. A continuous shift of patients in age groups 70+ into ambulatory care in emergency wards suggests that this division of labor needs to be further elaborated. Past legislation has not yet been fully implemented. In particular, it is necessary to decide which triage system emergency wards will need to use to identify low acuity patients for redirection into ambulatory care. We argue that implementation and evaluation of these requirements should be completed before further far reaching reforms are enacted.

[Outpatient pediatric care during the COVID-19 pandemic with special emphasis on screening examinations and immunizations]. / Ambulante kinder- und jugendärztliche Versorgung während der COVID-19-Pandemie unter besonderer Berücksichtigung der Inanspruchnahme von Früherkennung und Impfungen.

BACKGROUND: The COVID-19 pandemic has greatly changed the utilization of ambulatory medical care. Studies indicate that this also includes a decrease in pediatric prevention services. AIM: The aim of the study was to determine how the utilization of pediatric prevention services, in particular screening examinations and immunizations, developed over the course of the first pandemic wave until the end of September 2020 compared with the years 2015 to 2019. MATERIALS AND METHODS: A data analysis based on nationwide statutory medical claims data from the first quarter of 2015 to the third quarter of 2020 was conducted. All treatments of patients aged 0 to 17 years were included and the quarterly case numbers compared on an annual basis. By considering trends and seasonality, preventive and curative treatment cases were modelled as a time series and compared to their expected values. RESULTS AND DISCUSSION: No decreases in the quarterly numbers of screening examinations or immunizations were observed in 2020. In contrast, the number of curative pediatric cases decreased significantly in the second and third quarters of 2020 compared with the same periods of the previous years. Since there was no drop in the number of screening examinations, it should be assumed that the health problems addressed in this framework are detected in a timely manner despite the COVID-19 pandemic. However, since screenings do not cover all age groups, further investigation should be conducted to determine the health consequences of the observed decrease in curative cases.

A regional analysis of outpatient antibiotic prescribing in Germany in 2010.

The aim of this study was to investigate whether the previously reported regional variation in outpatient antimicrobial use density in Germany has persisted or changed over time and has been similar for both children and adults. Antibiotic [at least 1 Anatomical Therapeutic Chemical (ATC) Code 'J01' drug] prescription prevalence data for the year 2010 were analysed for 17 regions. The overall age-standardized antibiotic prescription prevalence ranged between 25.0 and 36.6% in the different regions. Regional prescription patterns for children differed from those seen in adults. Age-specific differences in antibiotic prescription prevalence need to be considered when comparing antibiotic consumption between regions.

Prescription prevalence and continuing medication use for secondary prevention after myocardial infarction: the reality of care revealed by claims data analysis.

BACKGROUND: Current guidelines recommend using aspirin, clopidogrel, beta-blockers, statins, and angiotensin converting enzyme (ACE) inhibitors after acute myocardial infarction (AMI). Although there is evidence that patients often stop taking these medications prematurely, long-term data reflecting the actual reality of care are lacking. We studied prescription prevalence and treatment persistence of secondary prevention in patients who had an AMI by analyzing relevant claims data from a German sickness fund, the Techniker Krankenkasse (these data are not necessarily representative of the entire German population). METHODS: Insurees who were discharged from the hospital between 2001 and 2006 with AMI as their main discharge diagnosis were classified as users or non-users of each of the types of drug listed above on the basis of the prescriptions that they obtained in the first 90 days after they left the hospital. Treatment persistence was statistically assessed with survival analysis. Switches from one drug class to another were not examined. RESULTS: Of 30,028 AMI patients, 82% were initially prescribed a beta-blocker, 73% a statin, 69% an ACE inhibitor, 66% aspirin (without self-medication), and 61% clopidogrel. Five years after discharge, 10% of the patients for whom aspirin was initially prescribed were still taking it; the corresponding figures for the other drug classes were 17% for statins, 31% for ACE inhibitors, and 36% for beta-blockers. The greatest drop in treatment persistence occurred approximately one year after the AMI. CONCLUSION: Treatment persistence with recommended medication after AMI is still in need of improvement. Patient education should start as soon as possible after infarction, because the greatest drops in medication use appear to occur within one year after AMI.

Surrogate outcomes in health technology assessment: an international comparison.

OBJECTIVES: Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. METHODS: We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. RESULTS: We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. CONCLUSIONS: HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

Use of Surrogate end points in HTA.

The different actors involved in health system decision-making and regulation have to deal with the question which are valid parameters to assess the health value of health technologies.So called surrogate endpoints represent in the best case preliminary steps in the casual chain leading to the relevant outcome (e. g. mortality, morbidity) and are not usually directly perceptible by patients. Surrogate endpoints are not only used in trials of pharmaceuticals but also in studies of other technologies. Their use in the assessment of the benefit of a health technology is however problematic.IN THIS REPORT WE INTEND TO ANSWER THE FOLLOWING RESEARCH QUESTIONS: Which criteria need to be fulfilled for a surrogate parameter to be considered a valid endpoint? Which methods have been described in the literature for the assessment of the validity of surrogate endpoints? Which methodological recommendations concerning the use of surrogate endpoints have been made by international HTA agencies? Which place has been given to surrogate endpoints in international and German HTA reports?For this purpose, we choose three different approaches. Firstly, we conduct a review of the methodological literature dealing with the issue of surrogate endpoints and their validation. Secondly, we analyse current methodological guidelines of HTA agencies members of the International network of agencies for Health Technology Assessment (INAHTA) as well as of agencies concerned with assessments for reimbursement purposes. Finally, we analyse the outcome parameter used in a sample of HTA reports available for the public.The analysis of methodological guidelines shows a very cautious position of HTA institutions regarding the use of surrogate endpoints in technology assessment. Surrogate endpoints have not been prominently used in HTA reports. None of the analysed reports based its conclusions solely on the results of surrogate endpoints. The analysis of German HTA reports shows a similar pattern.The validation of a surrogate endpoint requires extensive research, including randomized controlled trials (RCT) assessing clinical relevant endpoints. The validity of a surrogate parameter is rather technology-specific than disease-specific. Thus - even in the case of apparently similar technologies - it is necessary to validate the surrogate for every single technology (i. e. for every single active agent).The use of surrogate endpoints in the assessment of the benefit of health technologies is still to be seen very critically.

Aspirin use and breast cancer risk: a meta-analysis and meta-regression of observational studies from 2001 to 2005.

PURPOSE: To examine the recent epidemiological studies on aspirin use and breast cancer risk published from 2001 to 2005 within a meta-analysis, to investigate reasons for heterogeneity between the individual studies and to analyse a dose-response-relationship considering frequency and duration of use. METHODS: We systematically searched for cohort-studies and case-control-studies from 2001-2005, which evaluated the association between aspirin and breast cancer risk. We calculated a pooled estimate for the relative risk (RR) and investigated reasons for heterogeneity between the individual studies and analysed a dose-response-relationship using random effects mixed models. RESULTS: We identified 10 studies which met the inclusion criteria. The combined estimate of the RR was 0.75 (95%CI: 0.64, 0.88) using the random effects model. Heterogeneity between the studies could not be explained by the covariates study-type and study-population. The combination of frequency and duration of aspirin use resulted in a significant dose-response-relationship between aspirin use and breast cancer risk. Each additional pillyear reduced the breast cancer risk to about 2%. CONCLUSION: Our meta-analysis supports the current evidence that aspirin may reduce breast cancer risk. Moreover, a dose-response-relationship seems to exist. However, results have to be interpreted carefully, as exposure categories were defined very heterogeneously among the studies which weakens the validity of the pooled estimates.

Community pharmacy-based pharmaceutical care for asthma patients.

BACKGROUND: Despite significant progress in asthma drug therapy in recent years, there has been no major change in asthma morbidity and mortality. It is still important to determine whether pharmaceutical care (PC) influences health outcomes. OBJECTIVE: To evaluate the effectiveness of PC with regard to clinical, humanistic, and economic outcomes in adults with asthma. METHODS: An intervention study was conducted over 12 months. At baseline, 39 community/retail pharmacies, 84 primary care physicians (general practitioners, internal specialists, chest physicians), and 183 patients (aged 18-65 y) diagnosed with asthma were included. To evaluate economic outcomes, 2 German statutory health insurance funds provided 2 years of claims data for their insured patients (n = 55). A 1:10 matching was carried out to compare the data of this intervention subgroup with those of a control group (n = 550). RESULTS: Significant improvements were found for all humanistic outcomes (eg, asthma-specific quality of life, self-efficacy, knowledge, medication adherence). In addition, asthma severity, self-reported symptoms, peak expiratory flow, and patients' inhalation technique improved. Increases in forced expiratory volume in 1 second and vital capacity were not significant over time. Evaluation of the insurance claims data revealed a shift toward better adherence to evidence-based therapy. CONCLUSIONS: The study shows that PC for people with asthma has a positive impact on humanistic and, to some extent, on clinical outcomes. To determine potential economic benefits, future research should focus on patients with more severe asthma.