Gestational diabetes in Germany-prevalence, trend during the past decade and utilization of follow-up care: an observational study.

Gestational diabetes mellitus (GDM) is one of the most common medical complications in pregnancy. Information on key figures such as screening rates, prevalence of GDM or utilization of follow-up care and associated factors varies widely and is often lacking. The aim of our study is to provide information on screening rates for and prevalence of GDM as well as utilization of follow-up care in Germany. We used data (2010-2020) from a large, nationwide statutory health insurance containing information on inpatient and outpatient care, including diagnoses, medication and treatments. Descriptive analyses were performed to assess screening rates, prevalence of GDM and participation rates in follow-up care. A log-binomial regression model was calculated to analyze associated factors. Screening rates among pregnant women increased from 40.2% (2010) to 93.3% (2020) and prevalence from 9.4% (2010) to 15.1% (2020). The proportion of women attending follow-up care remained stable over time (around 42%). Age, educational level, insulin prescription, hypertension and obesity were positively associated with participation in follow-up care. Although over 90% of women in Germany are screened for GDM during pregnancy, follow-up care is used much less. Further research is needed to understand the trends in GDM healthcare (from screening to follow-up care) and the reasons for women's (non-)participation, as well as the attitudes and routines of the healthcare providers involved.

Study protocol for a mixed methods exploratory investigation of aftercare services for gestational diabetes in women to develop a new patient-centred model in Germany: the GestDiNa_basic study.

INTRODUCTION: Women with gestational diabetes mellitus (GDM) have a higher risk of developing type 2 diabetes mellitus compared with women who never had GDM. Consequently, the question of structured aftercare for GDM has emerged. In all probability, many women do not receive care according to the guidelines. In particular, the process and interaction between obstetrical, diabetic, gynaecological, paediatric and general practitioner care lacks clear definitions. Thus, our first goal is to analyse the current aftercare situation for women with GDM in Germany, for example, the participation rate in aftercare diabetes screening, as well as reasons and attitudes stated by healthcare providers to offer these services and by patients to participate (or not). Second, we want to develop an appropriate, effective and patient-centred care model. METHODS AND ANALYSIS: This is a population-based mixed methods study using both quantitative and qualitative research approaches. In various working packages, we evaluate data of the GestDiab register, of the Association of Statutory Health Insurance Physicians of North Rhine and the participating insurance companies (AOK Rheinland/Hamburg, BARMER, DAK Gesundheit, IKK classic, pronova BKK). In addition, quantitative (postal surveys) and qualitative (interviews) surveys will be conducted with randomly selected healthcare providers (diabetologists, gynaecologists, paediatricians and midwives) and affected women, to be subsequently analysed. All results will then be jointly examined and evaluated. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (Ethics Committee No.: 2019-738). Participants of the postal surveys and interviews will be informed in detail about the study and the use of data as well as the underlying data protection regulations before voluntarily participating. The study results will be disseminated through peer-reviewed journals, conferences and public information. TRIAL REGISTRATION NUMBER: DRKS00020283.

[Cancer Patients and the Last Year of Life: Palliative Care, Hospitalization and Place of Death]. / Krebserkrankung und das letzte Lebensjahr: Palliative Leistungen, Krankenhausaufenthalte und Sterbeort.

INTRODUCTION: Palliative care patients frequently suffer from cancer diagnoses. Specialised palliative home care (German acronym 'SAPV') enables patients with complex symptoms and intensive care needs to receive home care until death. In the German Federal State of Hesse, the first SAPV teams were set up in 2009. Against this background, the aim of this study was (i) to investigate the utilization of SAPV and specialised inpatient palliative care in the last year of life of cancer patients, (ii) to detect the medical professions prescribing SAPV and (iii) to analyse the place of death and the hospitalization rate in the last 91 days of life. METHODS: A retrospective secondary data analysis was conducted. Routine data from the statutory health insurance company AOK Hesse in Germany for 2009-2014 were analysed using descriptive statistical methods. The study population comprised breast, prostate, and colorectal cancer patients who died in the year of observation (2010-2014) and who were fully insured 360 days before death. RESULTS: Depending on the year of observation, 492-545 breast, 546-625 prostate, and 709-752 colorectal cancer patients were included in the study. The analysis showed an increase of cancer patients receiving palliative care from 2010 to 2014. A higher proportion of breast, prostate, and colorectal cancer patients received SAPV as compared to services from palliative care units or inpatient hospices. All in all, over 90% of the SAPV prescriptions were issued by family doctors. The hospitalization rate of cancer patients in the last 91 days of life as well as the share of those dying in hospital decreased between 2010 and 2014. CONCLUSION: The results must be assessed in the context of the implementation of SAPV in the state of Hesse. The increase of SAPV services and the reduction of hospitalizations at the end of life indicate a successful introduction of SAPV in the state of Hesse.

Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications.

OBJECTIVE: Combined hormonal contraceptives (CHC) exhibit differing risks for cardiovascular and thrombotic events (VTE). A European referral process confirmed higher VTE risks for 3rd generation gestagens and drospirenone. CHC are now grouped in risk classes (RC) I, II, and III, with RC III having a higher risk than RC I and X (risk not yet known). Marketing authorization holders were obliged to implement pharmacovigilance measures and risk minimization measures including changes of prescribing information. The study assessed whether these activities induced changes in prescription patterns. METHODS: German prescription data for 1.1 million women below 20 years of age were used to analyze the effects of interventions and potential influence factors using logistic regression. Descriptive statistics were calculated for prescriptions for 3.3 million women from January 2011 to March 2016. RESULTS: Shares of RC I and RC X recipients rose substantially over the observation period, while RC III recipient share showed a steady decrease. The referral induced a slightly faster decrease in RC III and increase in RC X. The implementation of pharmacovigilance measures manifested no additional effect. CONCLUSION: The decrease in RC III share already observed before the referral process can be explained with pre-existing discussions around CHC. The effect attributable to the referral was statistically significant, although very small. While evidence for a connection between interventions and prescription change is only indirect, the study shows that routine data are suitable for impact analyses, and monitoring prescribing patterns can be recommended as feedback after regulatory or political interventions. This is being followed up.

[Prevalence of dementia of insured persons with and without German citizenship : A study based on statuatory health insurance data]. / Prävalenz von Demenz bei Versicherten mit und ohne deutsche Staatsangehörigkeit : Eine Studie auf Basis von Daten der gesetzlichen Krankenversicherung.

BACKGROUND: Elderly people with a non-German background are a fast growing population in Germany. OBJECTIVES: Is administrative prevalence of dementia and uptake of nursing-home care similar in the German and non-German insured? MATERIALS AND METHODS: Based on routine data, administrative prevalence rates for dementia were calculated for 2013 from a full census of data from one large sickness fund. Patients with dementia (PWD) were identified via ICD-10 codes (F00; F01; F03; F05; G30). RESULTS: Administrative prevalence of dementia was 2.67% in the study population; 3.06% in Germans, and 0.96% in non-Germans (p value <0.001). Age and sex adjusted prevalence was comparable in the insured with and without German citizenship, except in women aged 80-84 (17.2 vs. 15.4) and for men in the age groups 80-84 (16.5 vs. 14.2), 85-89 years (23.4 vs. 21.5), and above 90 years of age (32.3 vs. 26.3). Standardized to the population of all investigated insured, 31.4% of all Germans with dementia had no longterm care entitlement vs. 35.5% of all patients without German citizenship. Of German patients, 55.1% were institutionalized vs. 39.5% of all patients without German citizenship. CONCLUSIONS: There was a higher prevalence of dementia in the very old insured without German citizenship compared to those with German citizenship, especially in men. Non-Germans showed lower uptake of nursing home care compared to Germans. Additionally, Germans had slightly higher nursing care entitlements. It should be investigated further how much of the difference is due to underdiagnosis, cultural differences, or lack of adequate diagnostic work-up.

[Primary and secondary data on dementia care as an example of regional health planning]. / Planung einer kleinräumigen Versorgung unter Nutzung von Primär- und Sekundärdaten am Beispiel von Demenzerkrankten.

BACKGROUND: Health service planning that takes into account as far as possible the regional needs and regional discrepancies is a controversial health issue in Germany. OBJECTIVES: In a pilot scheme, we tested a planning process for regional healthcare services, based on the example of dementia care. The aim of this article is to present the strengths and limitations of this planning process. MATERIALS AND METHODS: We developed an indicator set for dementia care based on routine regional data obtained from two German statutory health insurance companies. Additionally, primary data based on a questionnaire sent to all GPs in the area were evaluated. These data were expanded through the addition of official socio-demographic population data. Procedures and evaluation strategies, discussion of the results and the derivation of planning measures followed, in close agreement with a group of local experts. RESULTS: Few epidemiological data on regional variations in health care planning are publicly available. Secondary data from statutory health insurance companies can be assessed to support the estimation of regional health care needs, but interpretation is difficult. The use of surveys to collect primary data, and the assessment of results by the local health board may facilitate interpretation and may contribute towards more valid statements regarding regional health planning. CONCLUSIONS: Despite the limited availability of data and the considerable efforts involved in data analysis, the project demonstrates how needs-based health service planning can be carried out in a small region, taking into account the increasing demands of the local health care providers and the special local features.

[Anti-Diabetic Medication During the First Four Years of Treatment. A Study Based on Claims Data]. / Antidiabetische Medikation in den ersten vier Therapiejahren. Eine Studie auf Basis von Krankenkassendaten.

Background Ever since the UKPDS study reassessed the usefulness of the substance metformin in 1998, it has been the first-line medication in anti-diabetic treatment. In addition, new classes and agents released on the market have given rise to new treatment options. The present study investigates prescription practice at the onset of treatment and in the years thereafter and measures it against German diabetes guidelines. Database and Methods Database: Statutory health insurance sample AOK/KV Hesse; Ages: 40 and over (N = 142514). STUDY POPULATION: New users of anti-diabetic medication in 2008 (no medication during the preceding 730 days) (n = 1882). Investigation of anti-diabetic medication for four years after initial prescription with regard to substance spectrum, combination treatments, changes in treatment. Log-binomial model: factors influences onset of treatment with metformin versus sulfonylureas (age, sex, duration of illness, comorbidity). Results In 2008 67.9 % of patients began treatment exclusively with metformin, 17.8 % exclusively with sulfonylureas, and 6.7 % exclusively with insulin. Patients diagnosed as obese were significantly more likely to receive metformin. Elderly (80 years and over) or who had been diagnosed with diabetes at least three years prior or patients with renal or cerebrovascular illnesses were significantly less likely to receive metformin. Over the course of treatment, the number of patients receiving multiple medications increased from 5 % to 30 %. (The most frequent combinations were metformin/DPP4 inhibitor, metformin/sulfonylureas, and metformin/insulin.) Conclusion The findings show that German patient care guidelines on diabetes are reflected in prescription practice. Renal diseases are taken into account as potential contraindications for metformin treatment. In the wake of the expansion of approval for metformin in 2015 - reducing the creatinine clearance level to which application is possible - this first-line medication will be available for an ever larger circle of patients in the future.

Incidence estimate and guideline-oriented treatment for post-stroke spasticity: an analysis based on German statutory health insurance data.

BACKGROUND: Spasticity after stroke has been internationally recognized as an important health problem causing impairment of mobility, deformity, and pain. The aim of this study was to assess the frequency of first-ever and recurrent stroke and of subsequent spastic and flaccid paresis. Factors influencing the development of spasticity were analyzed. A further major aim was to provide a "real-life" assessment of the treatment of spasticity in Germany and to discuss this in view of the treatment recommended by German and international clinical guidelines. METHODS: The database used in this study comprised a cohort of 242,090 insurants from a large statutory health insurance fund in the federal state of Hesse, Germany. A first hospital discharge diagnosis in 2009 with any of the International Classification of Diseases, Tenth Revision (ICD-10) codes I60-I64 was used to identify patients with acute stroke (hemorrhage and ischemic). These patients were followed up six months after stroke to monitor whether they developed spastic or flaccid paresis (hospital or ambulatory care diagnoses ICD-10 code G81-G83 [excluding G82.6/G83.4/G83.8]). For patients with spastic paresis after stroke the spasticity treatment was analyzed for a six-month period (physiotherapy, oral muscle relaxants, intrathecal baclofen, and botulinum toxin). RESULTS: Standardized to the population of Germany, 3.7 per 1000 persons suffered a stroke in 2009 (raw 5.2/1000). Of all surviving patients, 10.2% developed spasticity within 6 months. Cox regression revealed no significant influence of patient age, gender, morbidity (diabetes, hypertensive diseases, ischemic heart diseases) or type of stroke on development of spasticity. 97% of surviving patients with spasticity received physiotherapy (inpatient care 89%, ambulatory care 48%). Oral muscle relaxants were prescribed to 13% of the patients. No patient received intrathecal baclofen or botulinum toxin. CONCLUSION: Claims data enabled analysis of the occurrence of stroke and post-stroke spasticity. These data provide insight into real-life treatment for spasticity in Germany. The proportion of patients who receive physiotherapy, which is the international guideline-recommended basic therapy after transition into ambulatory care, can be improved on. Botulinum toxin as an international guideline-based treatment option for focal spasticity has not been implemented in practice in Germany as yet.

['To read' does not imply 'to act upon': indicators of the acceptance of general practice guidelines. Results of a survey among quality circles of general practitioner centred care (Hausarztzentrierte Versorgung; HZV)]. / Gelesen ist noch nicht getan: Hinweise zur Akzeptanz von hausärztlichen Leitlinien. Eine Befragung in Zirkeln der Hausarztzentrierten Versorgung (HZV).

CONTEXT: Successful guideline implementation requires that the authors get feedback from target groups on the general acceptance of a guideline and the barriers to its implementation. The Guideline Group of General Practitioners (GPs) in Hesse continually surveyed participants of quality circles on pharmacotherapy who discussed these GP specific guidelines together with an analysis of their prescription behaviour. MATERIAL AND METHODS: Written survey of six general practice guidelines conducted among the members of quality circles in Hesse during 2006 and 2007. The response rate ranged from 69% (n=268; guideline on 'GP Communication Skills') and 80% (n=374; Guideline on 'Chronic Heart Failure'). The questionnaire focused on both general acceptance and the relevance and practicability of individual recommendations. RESULTS: With pharmacotherapeutic guidelines, between 75% (guideline for dyslipidaemia) and 86% (guideline for stable angina) would be recommended by the respondent GPs to colleagues. High practice relevance was attributed to the communication skills guideline by 70% of the GPs, but only about 50% would recommend it. Three quarters of the GP rated 18 out of 22 selected recommendations as being relevant to therapeutic quality assurance, and 11 of these recommendations as being practicable. Non-medical procedures requiring communication resources and time input as well as motivated patients were more often assessed as being more difficult to implement. DISCUSSION AND CONCLUSION: A written survey is a suitable tool for gaining insight into the acceptance of diagnostic and therapeutic strategies and for investigating reasons for the refusal of or the barriers to implementation. Recommendations that are poorly accepted and less likely to be implemented as well as possible barriers should be discussed within the guideline group and during circle sessions in order to modify the recommendation and/or develop aids to assist with its transfer into everyday practice.

The association of psychosocial factors with nausea and vomiting during pregnancy.

OBJECTIVES: The purpose of this study was to identify predictors for nausea and vomiting during pregnancy (NVP). STUDY DESIGN: A large German health insurance company provided data on prescription reimbursements and socio-demographics for all women giving birth between June 2000 and May 2001. The prescribed drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code. The data was linked to the database of the Bavarian Perinatal Study in psychosocial variables as possible predictors of NVP. RESULTS: The risk of developing NVP was two times higher for non-smokers than for smokers (OR=2.03 KI [1.02-4.05]) and dropped about 3% (OR=0.97 KI [0.94-0.99]) with every year of age. Being single raised the risk of NVP by about 50% (OR=1.49 KI [1.24-1.79]) compared to women who lived with a partner, and among these women living alone, working lowered the adjusted risk about two thirds (OR=0.34 KI [0.24-0.49]) compared to women who did not work. CONCLUSION: Psychosocial variables have a clear influence on nausea and vomiting during pregnancy. Physicians should be aware of this fact when seeing women asking for treatment.

Prescribing patterns of anti-emetic drugs during pregnancy in Germany.

OBJECTIVES: The purpose of this study was to examine the prescribing patterns of anti-emetics for pregnant women in Germany. METHOD: A large, nation-wide German statutory sickness fund provided data of reimbursed prescriptions and personal data for all insured women giving birth between June 2000 and May 2001 (n = 41,293). The prescribed drugs were classified according to the Anatomical Therapeutic Chemical code. RESULT: About 13.9% (n = 5,746) of all pregnant women received an anti-emetic prescription. Over 98.5% of these women were treated with anti-emetics that are considered safe. But only 27.8% received the recommended anti-histamine meclozine and 2.1% the safest drug pyridoxine. CONCLUSION: As there are no official guidelines for the treatment of nausea and vomiting during pregnancy in Germany, many different drugs are used, sometimes ignoring effectiveness and even safety. Therefore, evidence-based guidelines for anti-emetic therapy are needed.

Antibiotics in pregnancy: analysis of potential risks and determinants in a large German statutory sickness fund population.

PURPOSE: Antibiotics are frequently prescribed drugs in pregnancy. The purpose of the study was to analyse the use, the potential risks and the determinants of systemic antibiotic prescriptions during pregnancy. METHODS: A large, nation-wide acting German statutory sickness fund provided prescription data and personal data of 41,293 pregnant women. For this study, all prescriptions of systemic antibiotics (ATC: J01) dispensed to each woman during a 21-month period were analysed. We used the FDA risk classification system and enrolled a literature search to identify potentially harmful antibiotics. To investigate the impact of geographical and socio-economic determinants in antibiotic prescribing, a multivariate logistic regression model was performed. RESULTS: Of the 41,293 women, 19.7% received at least one antibiotic drug during pregnancy. There was a shift to relatively safe and reduced antibiotic drug use during pregnancy. Prescribing of contraindicated antibactericals or potentially harmful drugs was seen in 521 women (1.3% of all women). In the logistic regression, being younger than 21 years (adjusted OR 2.14, 95%CI 1.80-2.53) or being welfare recipient (adjusted OR 1.57, CI 1.25-2.00) was strongly associated with higher antibiotic use. Significantly lower antibiotic use was seen in 5 of 16 German federal states (OR 0.74-0.83). CONCLUSIONS: About 20% of pregnant women received antibiotics, and 1.3% received a harmful drug. To minimise the risks, detailed guidelines are needed for the antibiotic treatment during pregnancy.

Drug prescription in pregnancy: analysis of a large statutory sickness fund population.

OBJECTIVE: To examine the prescription of drugs in Germany prior to, during and after pregnancy. METHODS: For the first time, prescription data of a large cohort of pregnant women, from a German statutory sickness fund, were available for scientific analysis. For each woman who gave birth between June 2000 and May 2001 reimbursed prescriptions for two periods (90 days each) before pregnancy, three during and two after delivery were considered. The drugs were classified according to the ATC code. RESULTS: Of the 41,293 women, 96.4% received at least one drug during pregnancy. A median of 7 drugs per women was prescribed. Excluding vitamins, minerals, iodide and iron, 85.2% received at least one drug and the median was 3. Magnesium, which was seldom prescribed outside of pregnancy, was by far the most frequently prescribed substance (20% of all prescriptions, 61% of the women). Iron (54% of the women) and iodide (31%) were also prescribed often. The prescription rates of gynaecological antiinfectives (maximum in third trimester: 23% of the women), antacids (max. in third trim.: 11%), as well as antiemetics and antinauseants (max. in first trim.: 8%) during pregnancy considerably increased. A decrease was seen for analgesics, antiinflammatory and antirheumatic drugs, muscle relaxants, ophtalmologicals and anti-acne preparations, for example. Potential teratogenic drugs were prescribed to 1.3% of the women. CONCLUSION: This analysis of a large nation-wide cohort of pregnant women showed that during pregnancy drugs were prescribed to most women, even when vitamins, minerals, iodide and iron were omitted. Magnesium and iron seemed to have been over-prescribed. On the other hand, the official recommendation for iodide substitution, to prevent thyroid diseases in mother and child, was insufficiently implemented. In our opinion, regular analysis of prescription data can identify potential harmful therapies and focal points where guidelines are needed and can check their implementation.