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Introduction: In the past decade, a legal framework was created in Germany that promotes intense collaboration at the interface between primary and secondary care. This overview article distinguishes between the effects of two complementary programs aimed at improving ambulatory care in Baden-Wuerttemberg: (1) general practitioner-centered care (GPCC), which strengthens the role of general practitioners, and (2) collaborative cardiology care (CCC), which coordinates primary and cardiology care., Methods: The overview article presents two already published studies that assess the impact of the programs on hospitalizations in patients with chronic heart failure (CHF) based on claims data from 2016. The hospitalization rate of patients enrolled in GPCC (N=75,096) and CCC (N=13,404) were compared with corresponding control groups (N=65,618 and N=8,776 respectively)., Results: The hospitalization rate in GPCC was lower than in the control group (risk ratio 0.97; 95% CI: 0.95-0.99, P=0.0024). GPCC patients with CHF that received specialist cardiology care as part of CCC had significantly lower hospitalization rates than those receiving standard cardiology care (risk ratio 0.92; 0.88-0.97, P=0.0014)., Discussion: This overwiew study shows that reforming medical care and compensation at the interface between general practice and specialist care can lead to fewer hospital admissions in patients with CHF., Conclusion: Overall, this article underlines the importance of collaboration between primary care physicians and specialists for patients with CHF that are receiving ambulatory care., (Copyright © 2023. Published by Elsevier GmbH.)

Aim of the Study: The evaluation of complex interventions such as different forms of healthcare are methodologically challenging. The aim of this study was to use generalized estimating equations (GEE) to investigate how quality differences between family practitioner-based healthcare (HZV) and standard care develop over time., Methods: A longitudinal secondary data analysis for 2011-2018 was conducted using routine data from the AOK Baden Wuerttemberg health insurer. A dynamic cohort of insured persons that fulfilled the inclusion criteria were included in the analysis at the beginning of each year of observation, so the size and composition of the cohorts varied from year to year. Quality differences between HZV and standard care were investigated, whereby an autoregressive covariance structure (AR1) was assumed for multiple measurements. Under observation were a group variable for healthcare type, a variable for year of observation, and any interaction between the two. The resulting estimates provided information on the relationship between the two groups at the beginning of the observation period, and on how the groups developed both individually and in relation to one another over time., Results: The GEE were used exemplarily on the quality indicator prescription of potentially inappropriate medication (PIM) in elderly insured patients. At the beginning of the observation period, the chance of PIM in those over 65 years of age (year 2018; N=628,523) was significantly lower in the HZV group than in the group receiving standard care (odds ratio 0.978; 95% confidence interval: 0.968-0.987). The chance of a PIM in the following seven years declined in both groups, but faster in the HZV group than the group receiving standard care., Conclusion: A secondary data-based trend analysis with GEE of quality differences in comparison groups over time has considerable potential in the evaluation of new and existing forms of healthcare., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Thieme. All rights reserved.)

Objectives: We evaluated a collaborative care program aimed at improving cooperation among general practitioners (GPs) and cardiologists in Baden-Wuerttemberg, Germany. The program focused on improving care for patients with chronic cardiac conditions., Study Design: We conducted a retrospective cohort study. The observation period was 2 years., Methods: The study was based on claims data and compared groups of patients who participated in the collaborative care program (GP-centered care and the cardiology contract) with patients receiving usual care. The evaluation focused on care coordination, quality, health service utilization, and costs in patients with heart failure, coronary heart disease, heart rhythm disorders, and/or valvular heart disease (disease cohorts). Multivariable regression models were used to adjust for differences in patient characteristics between the groups., Results: Across all disease cohorts, participation in the collaborative care program was associated with better care coordination and improved quality in a broad range of indicators (pharmacotherapy and vaccination). Results showed lower emergency service utilization and hospitalizations, lower consultation frequencies with GPs and specialists, and a shift from inpatient to outpatient procedures. Program participation resulted in higher costs for outpatient cardiologist treatment, but disease-specific costs were lower overall., Conclusions: The results underline evidence that health care service programs that strengthen collaboration between GPs and cardiologists can substantially improve the care of patients with chronic cardiac conditions while simultaneously reducing costs.

In 2004, Germany introduced a program based on voluntary contracting to strengthen the role of general practice care in the healthcare system. Key components include structured management of chronic diseases, coordinated access to secondary care, data-driven quality improvement, computerized clinical decision-support, and capitation-based reimbursement. Our aim was to determine the long-term effects of this program on the risk of hospitalization of specific categories of high-risk patients. Based on insurance claims data, we conducted a longitudinal observational study from 2011 to 2018 in Baden-Wuerttemberg, Germany. Patients were assigned to one or more of four open cohorts (in 2011, elderly, n = 575,363; diabetes mellitus, n = 163,709; chronic heart failure, n = 82,513; coronary heart disease, n = 125,758). Adjusted for key patient characteristics, logistic regression models were used to compare the hospitalization risk of the enrolled patients (intervention group) with patients receiving usual primary care (control group). At the start of the study and throughout long-term follow-up, enrolled patients in the four cohorts had a lower risk of all-cause hospitalization and ambulatory, care-sensitive hospitalization. Among patients with chronic heart failure and coronary heart disease, the program was associated with significantly reduced risk of cardiovascular-related hospitalizations across the eight observed years. The effect of the program also increased over time. Over the longer term, the results indicate that strengthening primary care could be associated with a substantial reduction in hospital utilization among high-risk patients.

Background: Oral anticoagulants can cause potentially serious adverse events. Therefore, before prescribing oral anticoagulants for ischemic stroke prevention in patients with atrial fibrillation (AF), stroke risk assessment is required to identify patients that are likely to benefit from treatment. Current guidelines recommend the CHA 2 DS 2 -VASc-score for stroke risk assessment. The CHA 2 DS 2 -VASc-score is based on observational studies from different treatment settings and countries. As ischemic stroke risk differs by setting and region, the aim of this study is to estimate ischemic stroke risk (stratified by the CHA 2 DS 2 -VASc-score) for a broadly representative population with AF from southern Germany and compare them to results from previous studies., Methods: The study design is a retrospective cohort study on patients with atrial fibrillation based on secondary data. We calculated CHA 2 DS 2 -VASc-score based on patient's diagnoses recorded in the year 2014 and assessed outcomes in 2015-2016. The primary outcome is hospitalization for ischemic stroke. The secondary outome is hospitalizations for any thromboembolic event, including ischemic stroke, transient ischemic attack, peripheral arterial embolism, pulmonary embolism, and mesenterial embolism. We estimated the incidence rates of the outcomes (and corresponding 95%-confidence intervals) stratified by CHA 2 DS 2 -VASc-score., Results: The primary endpoint occurred in 961 of the 30,299 patients constituting the study population, resulting in a total incidence rate of 2.2 per 100 person-years. The secondary endpoint occurred in 1553 patients (3.6 per 100 person-years). Ischemic stroke rates stratified by the CHA 2 DS 2 -VASc-score tended to be lower than those reported previously. Thromboembolic event rates stratified tended to be similar to those reported previously., Conclusions: Our results show that the performance of the CHA 2 DS 2 -VASc-score differs in the German population, as compared to internationally published data, with an overall trend towards lower risk of ischemic stroke in uncoagulated patients with AF. These results should not be practice changing, but they emphasize that stroke risk estimation in patients with atrial fibrillation should be further refined.

Objectives: On the basis of current treatment guidelines, we developed and validated a medication-based chronic disease score (medCDS) and tested its association with all-cause mortality of older outpatients., Study Design and Setting: Considering the most prevalent chronic diseases in the elderly German population, we compiled a list of evidence-based medicines used to treat these disorders. Based on this list, a score (medCDS) was developed to predict mortality using data of a large longitudinal cohort of older outpatients (training sample; MultiCare Cohort Study). By assessing receiver-operating characteristics (ROC) curves, the performance of medCDS was then confirmed in independent cohorts (ESTHER, KORA-Age) of community-dwelling older patients and compared with already existing medication-based scores and a score using selected anatomical-therapeutic-chemical (ATC) codes., Results: The final medCDS score had an ROC area under the curve (AUC) of 0.73 (95% CI 0.70-0.76). In the validation cohorts, its ROC AUCs were 0.79 (0.76-0.82, KORA-Age) and 0.74 (0.71-0.78, ESTHER), which were superior to already existing medication-based scores (RxRisk, CDS) and scores based on pharmacological ATC code subgroups (ATC3) or age and sex alone (Age&Sex)., Conclusions: A new medCDS, which is based on actual treatment standards, predicts mortality of older outpatients significantly better than already existing scores., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: In recent years, models for the delegation of GP tasks to non-physician medical staff have been tested, implemented in a general practice setting and, to some extent, funded by health insurance companies., Aim: How were changes in the spectrum of tasks performed by non-physician staff viewed and accepted by patients?, Methods: Between October 2014 and January 2015, a written survey was conducted among chronically ill patients (≥ 65 years of age) receiving health care from health care assistants (HCA) with or without the additional "health care assistant in the family practice", or VERAH qualification. Using a self-developed survey, based on a previous collection of data, patients were asked about various aspects of health care provided by HCAs., Results: 77 practices participated and a total of 1 266 patients were surveyed. The patients said the HCAs had a role to play in many aspects of their health care. More than half the patients said HCAs could take responsibility for some of the home visits and contacts in the practice. Almost without exception, patients regarded the organisational, healthcare and other supporting services performed by the HCAs as very good. The results were more heterogeneous for specific consulting services. While consultations on vaccinations, preventive services, medical examinations and medication adherence were well accepted, this was much less often the case with advice on lifestyle. Many patients see HCAs as additional and competent persons they can trust, and could well imagine HCAs taking on responsibility for further delegable services., Conclusion: At least among GP-centered health care programme participants, many healthcare services delegated to HCAs were appreciated and accepted by patients. Home visits and case management, in the sense of structured individual health care for patients with special needs, are further services that may be well suited for delegation. This should be investigated in further studies (including qualitative studies)., Competing Interests: Das Projekt „Evaluation der Hausarztzentrierten Versorgung (HzV) nach § 73 b SGB V in Baden-Württemberg (2013–2016)“, wurde von der AOK Baden-Württemberg, der Hausärztlichen Vertragsgemeinschaft Baden Württemberg und dem MEDI-Verbund Baden-Württemberg finanziell unterstützt. Die wissenschaftlichen Analysen erfolgten vollkommen unabhängig. Eine inhaltliche Einflussnahme des Sponsors auf die Ergebnisse erfolgte zu keinem Zeitpunkt., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: To compare the development of diabetes complications, measured in terms of clinical end points, of patients enrolled in general practitioner (GP)-centered healthcare (Hausarztzentrierte Versorgung [HZV]) and patients in usual GP care (non-HZV) over 4 years., Study Design: Retrospective closed cohort study based on German claims data., Methods: The main end points in our evaluation were dialysis, blindness, amputation, stroke, myocardial infarction, cardiovascular disease, hypoglycemia, and mortality. We used Cox proportional hazards regression models for multivariable analysis., Results: We included 217,964 patients in our study: 119,355 were enrolled in HZV and 98,609 were in non-HZV. Compared with non-HZV, the HZV group had a 15.6% lower risk of requiring dialysis during the 4 years of observation. Risks were also lower in the HZV group for all other end points except mortality., Conclusions: The results of the present study indicate that GP-centered healthcare is associated with a delay in the occurrence of serious diabetes complications and reduces the risk of diabetes complications. This may be because GP-centered care is associated with improved coordination of care.

Objective: To improve medication appropriateness and adherence in elderly patients with multimorbidity, we developed a complex intervention involving general practitioners (GPs) and their healthcare assistants (HCA). In accordance with the Medical Research Council guidance on developing and evaluating complex interventions, we prepared for the main study by testing the feasibility of the intervention and study design in a cluster randomised pilot study., Setting: 20 general practices in Hesse, Germany., Participants: 100 cognitively intact patients ≥65 years with ≥3 chronic conditions, ≥5 chronic prescriptions and capable of participating in telephone interviews; 94 patients completed the study., Intervention: The HCA conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision-support system (CDSS), the GPs discussed medication intake with patients and adjusted their medication regimens. The control group continued with usual care., Outcome Measures: Feasibility of the intervention and required time were assessed for GPs, HCAs and patients using mixed methods (questionnaires, interviews and case vignettes after completion of the study). The feasibility of the study was assessed concerning success of achieving recruitment targets, balancing cluster sizes and minimising drop-out rates. Exploratory outcomes included the medication appropriateness index (MAI), quality of life, functional status and adherence-related measures. MAI was evaluated blinded to group assignment, and intra-rater/inter-rater reliability was assessed for a subsample of prescriptions., Results: 10 practices were randomised and analysed per group. GPs/HCAs were satisfied with the interventions despite the time required (35/45 min/patient). In case vignettes, GPs/HCAs needed help using the CDSS. The study made no patients feel uneasy. Intra-rater/inter-rater reliability for MAI was excellent. Inclusion criteria were challenging and potentially inadequate, and should therefore be adjusted. Outcome measures on pain, functionality and self-reported adherence were unfeasible due to frequent missing values, an incorrect manual or potentially invalid results., Conclusions: Intervention and trial design were feasible. The pilot study revealed important limitations that influenced the design and conduct of the main study, thus highlighting the value of piloting complex interventions., Trial Registration Number: ISRCTN99691973; Results., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices., Objective: To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care., Design: Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508)., Setting: 115 primary care practices in Germany., Patients: 2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data., Intervention: Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care., Measurements: All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D])., Results: Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month., Limitation: Small number of primary care practices and low intensity of intervention., Conclusion: This low-intensity intervention did not reduce all-cause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients., Primary Funding Source: AOK Baden-Württemberg and AOK Bundesverband.

Background and Aim of the Study: Transcatheter procedures are considered the therapy of choice for high-risk patients who are not eligible for surgical aortic valve replacement. Although its utility is debated, the logistic EuroSCORE I is still the most frequently used risk calculator for cardiac surgery in Europe, and was used in the present study to identify patients with an extremely high risk of predicted perioperative mortality., Methods: This single-centre study included 319 consecutive patients who underwent transapical or transaortic transcatheter aortic valve implantation (TAVI) between September 2008 and December 2012. Combined hybrid procedures and transfemoral TAVI patients were excluded. Those patients predicted to have an excessively high risk of perioperative mortality (EuroSCORE >40%, n = 90) were compared to those with a lower calculated risk (EuroSCORE <40%, n = 229) with respect to perioperative complications, short-term-mortality and major adverse cardiac and cerebrovascular events., Results: The 30-day mortality was 12.2% (n = 11) in the extremely high-risk group, and 6.6% (n = 15) in the lower-risk group (p = 0.08). There were no significant differences in the stroke rate (3.3% versus 0.4%, p = 0.07) or the incidence of acute kidney injury stage 3 (11.1% versus 5.2%, p = 0.32). The establishment of cardiopulmonary bypass (3.9% versus 11.1%, p = 0.02), conversion to sternotomy (1.3% versus 5.6%, p = 0.04), mean ventilation time (15.2 h versus 43.5 h, p = 0.007) and length of intensive care unit stay (2.9 days versus 6.8 days, p <0.001) were all significantly lower in the lower-risk group., Conclusion: The data acquired verified that TAVI is a safe procedure, even in patients with an extremely high predicted risk of perioperative mortality and major adverse cardiac and cerebrovascular events. Furthermore, the analysis substantiated the need for individualized risk evaluation.

Background: GP-centered health care ("Hausarztzentrierte Versorgung", HzV)-the terms of which are described in § 73b of the Social Code Book V-came into effect in Baden-Württemberg, Germany, on 1 July 2008. The HzV is aimed at enhancing health care for patients with chronic diseases and complex health care needs (e.g., those requiring long-term care)., Objectives: On the basis of four working packages (WP I-WP IV), the present paper examines the impact that GP-centered health care has had on patients insured by the "AOK" regional sickness fund and their GPs. WP I addresses the association between HzV participation and the corresponding health care utilization of patients on the basis of claims data. WP II looks at any changes that GPs and patients noticed were potentially attributable to HzV participation. WP III focuses on health care assistants in primary care ("Versorgungsassistenten in der Hausarztpraxis", VERAH). These assistants play a special role within the framework of the HzV. WP IV analyzes the quality of health care for patients aged 65 years and over, also on the basis of claims data., Materials and Methods: A mixed methods design was used for this evaluation, and quantitative and qualitative approaches taken. This design enabled insights into the implementation of the HzV in regular health care to be obtained from different perspectives., Results: Numerous positive associations between HzV participation and the variables of interest were observed for all WPs. These are presented in detail in the paper., Conclusion: The results obtained so far clearly support the continuation of HzV and associated evaluations.

Background: In the face of demographic changes, the aging of the population, and the increase in chronic morbidity and complexity, efficient primary care is needed to ensure comprehensive and high-quality health care. The general practitioner (GP) can only cope with this task, if certain preconditions are met., Objectives: To strengthen primary health care, the German legislator added § 73b, "GP-centered health care" ("Hausarztzentrierte Versorgung", HzV) to the Social Code Book V. This article seeks to illustrate the rationale and general set-up of the HzV and to report on its dissemination. We discuss whether or not the HzV can promote the preconditions required., Materials and Methods: Literature search, querying participants., Results: Several elements of the HzV, such as lump-sum reimbursement, obligatory participation in structured quality circles, continuing education, and the qualification of non-medical health care assistants help to promote an environment that enables GPs to fulfill their new role. Considering all assured people and the Federal Republic as a whole, the distribution of the HzV is poor. However, a growing number of contracts (currently: 79) and participants (currently > 3.6 million) is expected., Conclusions: The establishment of efficient primary care is heavily promoted by the HzV. In future, ways must be found to overcome the inflexible borders between sectors and to integrate community-based health care, which truly focuses on the patients needs. The HzV can be seen as a starting point.

Critical incident reporting and learning systems (CIRS) have been recommended as an instrument to promote patient safety for a long time. However, both their scientific value and their actual impact have been disputed. The nationwide German CIRS for primary care has been in operation since September 2004. Incident reports are available online, and the question is how to make use of this large database to promote patient safety. A descriptive analysis of the content was performed, classifying, in particular, types of error and contributing factors. Its usage is presented for the period from 2004 to 2013 where a total of 483 complete reports have been recorded. Their severity ranges from 35.6 % with no tangible harm to patients to 14.6 % with important harm (or errors contributing to mortality). The majority of them (74.2 %) were process errors, compared to 25.8 % knowledge/skills errors. The main areas involved were treatment/medication (54.2 %) and diagnosis/tests (16.4 %). The results of the analysis of the CIRS cannot be used as an epidemiological data source. And yet they will generate hypotheses for further research in the field of patient safety. Moreover, they will enable practice teams to make themselves familiar with and learn from critical incident analysis. In spite of the specific difficulties in ambulatory care, CIRS should be promoted in this sector to enable learning. Participation in CIRS can be increased by enhanced feedback., (Copyright © 2014. Published by Elsevier GmbH.)

Background: In Germany, about 20% of the total population have a migration background. Differences exist between migrants and non-migrants in terms of health care access and utilisation. Colorectal cancer is the second most common malignant tumour in Germany, and incidence, staging and survival chances depend, amongst other things, on ethnicity and lifestyle. The current study investigates whether stage at diagnosis differs between migrants and non-migrants with colorectal cancer in an area of high migration and attempts to identify factors that can explain any differences., Methods/design: Data on tumour and migration status will be collected for 1,200 consecutive patients that have received a new, histologically verified diagnosis of colorectal cancer in a high migration area in Germany in the previous three months. The recruitment process is expected to take 16 months and will include gastroenterological private practices and certified centres for intestinal diseases. Descriptive and analytical analysis will be performed: the distribution of variables for migrants versus non-migrants and participants versus non-participants will be analysed using appropriate χ2-, t-, F- or Wilcoxon tests. Multivariable, logistic regression models will be performed, with the dependent variable being the dichotomized stage of the tumour (UICC stage I versus more advanced than UICC stage I). Odds ratios and associated 95%-confidence intervals will be calculated. Furthermore, ordered logistic regression models will be estimated, with the exact stage of the tumour at diagnosis as the dependent variable. Predictors used in the ordered logistic regression will be patient characteristics that are specific to migrants as well as patient characteristics that are not. Interaction models will be estimated in order to investigate whether the effects of patient characteristics on stage of tumour at the time of the initial diagnosis is different in migrants, compared to non-migrants., Discussion: An association of migration status or other socioeconomic variables with stage at diagnosis of colorectal cancer would be an important finding with respect to equal health care access among migrants. It would point to access barriers or different symptom appraisal and, in the long term, could contribute to the development of new health care concepts for migrants., Trial Registration: German Clinical Trials Register DRKS00005056.

A debate on the application of quality indicators (QIs) arose among the members of the German College of General Practitioners and Family Physicians (DEGAM) when two QI systems for ambulatory care (QISA and AQUIK) were published in a short time interval. A research question that emanated from this discussion was whether appropriate QI might be developed based on German general practice guidelines. In spring 2010, the DEGAM guideline committee (SLK) decided to conduct a project on guideline-based development of QIs using the DEGAM guidelines for dementia, neck pain and sore throat. All members of the SLK were invited to participate in the development process which comprised three face-to-face meetings and four paper-pencil ratings. Finally, 17 QIs for the three guidelines on dementia (n=8), neck pain (n=7) and sore throat (n=2) emerged. These QIs received different ratings in the dimensions relevance, practicability, and appropriateness for public reporting as well as for pay for performance. In this project, guideline authors themselves developed QIs based on German general practice guidelines for the first time ever. Not before practice administration systems facilitate the availability of data in the context of clinical documentation, the practicability of the new QIs can be proven in real every-day practice., (Copyright © 2012. Published by Elsevier GmbH.)

Considering the demographic development models for primary care have to be focused on chronic illness care especially. The so called "Hausarztzentrierte Versorgung" (HzV) in Baden-Wuerttemberg constitutes such a model of an implementation of family doctor-centred health care. For evaluation purposes the perspective of patients is of particular interest. Therefore the aim of this study was to analyse how chronically ill patients assess their medical care. Altogether 53 primary care practices in Baden-Wuerttemberg took part in a patient survey. The quality of chronic illness care from the patients' perspective was assessed by means of the PACIC short form. Furthermore the general satisfaction with care as well as sociodemographic characteristics were determined. For analysis two different groups were regarded: HzV-doctor and HzV-patient with a chronic condition (group 1) and non-HzV-doctor and non-HzV-patient with a chronic condition (group 2). Altogether 2,535 patients were recruited for the survey (response rate 47.8%). Out of these, 836 patients could be assigned to group 1 and 319 patients could be assigned to group 2. Patients in both groups were very satisfied with their care. The patients in group 1 stated more frequently that they received a written treatment plan from their general practitioner and that they were asked about their state of health when leaving the practice. Overall satisfaction was positively associated with organisation of care (β= 0.484), support in difficult situations (β= 0.171) and information on the usefulness of consulting other doctors (β= 0.163) with an explained variation of R(2)=0.459. Irrespective of their group affiliation patients rate the medical care of their chronic condition very positively. Especially the assessment of the quality of care from the perspective of different patient groups (HzV participants and non-HzV participants) could contribute essentially as a feedback for physicians concerning the implementation of the main contents of the HzV for participating physicians., (Copyright © 2013. Published by Elsevier GmbH.)

Problem: Family doctor centred health care (German abbreviation: HzV) agreements in Baden-Wuerttemberg provides that every year the strategies and results of at least two high-quality guidelines shall be discussed and worked on in quality circles. In this regard, the 'heart failure' guideline by the German Society of General Practice and Family Medicine (DEGAM) is especially important due to the high treatment costs and the continuously increasing prevalence of this medical condition. Another specified objective of the HzV agreements is to increase the DMP participation rate. The study addressed two questions: Is the medical care provided to patients with chronic heart failure who are being treated under HzV more compliant with guidelines than routine care? Does further improvement result from working on the guidelines in quality circles?, Methods: Routine data were provided by the AOK Baden-Wuerttemberg statutory health insurance company. Patients with heart failure receiving treatment under an HzV agreement (HzV group) were compared with patients receiving routine care (control group) with regard to quality of care eight months before and eight months after working on the guideline on heart failure in quality circles. Primary endpoints were the prescription of ACE inhibitors, AT1 antagonists and beta blockers in accordance with guidelines. Adjustment for various covariates was done by means of multivariate multilevel regression., Results: Data were available for 3,667 practices [1,295 HzV practices; 2,158 non-HzV practices]. After applying validated diagnosis criteria, 16,584 patients were included in the intervention group and 28,992 in the control group. The HzV group received significantly better care in terms of the primary endpoint "prescription of ACE inhibitors or AT1 antagonists" (73.1 % vs. 69.3 % of the patients received ACE inhibitors or AT1 antagonists at T0 (OR 1.40; 95% CI [1,25; 1,57]; p < .001). 54.2 % vs. 52.3 % of the patients received beta blockers at T0 (not significant after adjustment, p = .260). No further improvement could be demonstrated to result from working on guidelines in quality circles., Discussion and Conclusion: The treatment of HzV patients with chronic heart failure is more compliant with guidelines than that of patients receiving routine care. Quality of care was already high at the beginning, and working on guidelines in quality circles had no noticeable effect. The increased DMP participation rate, which is one of the specified objectives of the HzV agreements, appears to have a mediation effect., (Copyright © 2013. Published by Elsevier GmbH.)

Background: Patients with chronic kidney disease (CKD) are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care., Methods: A cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (≥70 years) suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by more than 30%., Results: Data from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%., Conclusions: A multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices., Trial Registration: Current Controlled Trials ISRCTN02900734.

The publication of two German systems of quality indicators for ambulatory care (AQUIK and QISA) in 2009 stimulated a discussion in German general practice about how to appropriately measure the quality of care in general practice / family medicine. The basic properties and requirements of quality indicators (QIs) in the international literature are discussed in terms of their ability to measure the specific processes of care in general practice. In the second part of the article the QISA system is presented as an example of a methodologically sound development of QIs for ambulatory care for use in both small practices and practice networks. In addition, the context of application and usage of QIs in primary care and the quality control they may provide are discussed. We conclude that important methodological problems have yet to be solved, particularly with measuring 'horizontal' dimensions of quality in primary care (such as comprehensiveness, co-ordination and person-centredness), but that the use of QIs may increase the visibility of general practice in Germany.

In its 2009 report the Federal Advisory Council on the Assessment of Developments in the Health Care System developed a model of Primary Care Practices for future general practice-based primary care. This article presents the theoretical background of the model. Primary care practices are seen as developed organisations requiring changes at all system levels (interaction, organisation, and health system) to ensure sustainability of primary care functions in the future. Developments of the elements comprising the health care system may be compared to the developments and proposals observed in other countries. In Germany, however, the pace of these developments is relatively slow., (Copyright © 2011. Published by Elsevier GmbH.)

Background: Quality circles (QC) are viewed as one of the most important tools of quality improvement and continuing education in ambulatory care. Yet, little is known about the quality of QC work., Methods: From 1995 to 2007, an external assessment of QC work took place at four regional Associations of Statutory Health Insurance (SHI) Physicians. After each meeting, QC leaders completed questionnaires. This basic documentation focused on important features of QC work--continuity, topics, methods, results and satisfaction., Results: 28,800 meetings in 1,640 quality circles were documented, and 27,255 documents from 1,241 groups analysed. Continuity was high over long periods, and medical topics were dealt with in more than 80% of the time. The use of appropriate methods, however, have room for improvement. Participants were very satisfied., Conclusions: For the first time the quality of QC structures, processes and results was assessed in Germany using a broad dataset. The working principles of QC appear to be well-established. Using the basic documentation practical recommendations are made to improve the quality of QC.

Context: ICD-10-coded diagnoses from claims records are frequently used as morbidity indicators for research as well as for risk adjustment purposes in quality management and remuneration. A requirement for this application is the high validity of the diagnoses. In GP practices in particular, it is questionable whether claims-based diagnoses realistically reflect the health problems of patients treated over a one year period., Methods: In a retrospective cross-sectional study of a random sample of 250 patients from 10 GP practices we examined whether, on the basis of the patients' medical records, health problems treated in the year 2003 matched claims-based diagnoses within the same time period., Results: In spite of a high mean of 6.1 claims-based diagnoses per patient, health problems treated within the study period were under-reported in 30% of the cases, mainly relating to non-severe diagnoses frequently encountered in GP practice, chronic conditions not requiring medication, and diagnoses justifying a screening test. An over-reporting for diseases not treated within the study period was observed in 19% of the cases, most often in the case of permanent chronic conditions. In 11% of cases the ICD-10 codes of claims-based diagnoses and the diagnoses in the medical records did not match ("erroneous codes"). For six of the diagnoses most common in GP practice (hypertension, diabetes, hyperlipoproteinemia, cardiovascular disease, back pain, and acute respiratory tract infections) correctness at 71-93% was higher than completeness (56-86%)., Conclusion: The low validity of ICD-10-coded diagnoses from GP claims records calls their usefulness as morbidity indicators into question., (Copyright Georg Thieme Verlag KG Stuttgart . New York.)

Background: Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms., Objective: To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression., Design: Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned., Setting: 74 small primary care practices in Germany from April 2005 to September 2007., Patients: 626 patients age 18 to 80 years with major depression., Intervention: Structured telephone interview to monitor depression symptoms and support for adherence to medication, with feedback to the family physician., Measurements: Depression symptoms at 12 months, as measured by the Patient Health Questionnaire-9 (PHQ-9); secondary outcomes were patient assessment of chronic illness care, adherence to medication, and quality of life., Results: A total of 310 patients were randomly assigned to case management and 316 to usual care. At 12 months, 249 intervention recipients and 278 control patients were assessed; 555 patients were included in a modified intention-to-treat-analysis (267 intervention recipients vs. 288 control patients). Compared with control patients, intervention recipients had lower mean PHQ-9 values in depression symptoms (-1.41 [95% CI, -2.49 to -0.33]; P = 0.014), more favorable assessments of care (3.41 vs. 3.11; P = 0.011), and increased treatment adherence (2.70 vs. 2.53; P = 0.042). Quality-of-life scores did not differ between groups., Limitation: Patients, health care assistants, family physicians, and researchers were not blinded to group assignment, and 12-month follow-up of patients was incomplete., Conclusion: Case management provided by primary care practice-based health care assistants may reduce depression symptoms and improve process of care for patients with major depression more than usual care., Primary Funding Source: German Ministry of Education and Research.

Background: This study was carried out to compare the HRQoL of patients in general practice with differing chronic diseases with the HRQoL of patients without chronic conditions, to evaluate the HRQoL of general practice patients in Germany compared with the HRQoL of the general population, and to explore the influence of different chronic diseases on patients' HRQoL, independently of the effects of multiple confounding variables., Methods: A cross-sectional questionnaire survey including the SF-36, the EQ-5D and demographic questions was conducted in 20 general practices in Germany. 1009 consecutive patients aged 15-89 participated. The SF-36 scale scores of general practice patients with differing chronic diseases were compared with those of patients without chronic conditions. Differences in the SF-36 scale/summary scores and proportions in the EQ-5D dimensions between patients and the general population were analyzed. Independent effects of chronic conditions and demographic variables on the HRQoL were analyzed using multivariable linear regression and polynomial regression models., Results: The HRQoL for general practice patients with differing chronic diseases tended to show more physical than mental health impairments compared with the reference group of patients without. Patients in general practice in Germany had considerably lower SF-36 scores than the general population (P < 0.001 for all) and showed significantly higher proportions of problems in all EQ-5D dimensions except for the self-care dimension (P < 0.001 for all). The mean EQ VAS for general practice patients was lower than that for the general population (69.2 versus 77.4, P < 0.001). The HRQoL for general practice patients in Germany seemed to be more strongly affected by diseases like depression, back pain, OA of the knee, and cancer than by hypertension and diabetes., Conclusion: General practice patients with differing chronic diseases in Germany had impaired quality of life, especially in terms of physical health. The independent impacts on the HRQoL were different depending on the type of chronic disease. Findings from this study might help health professionals to concern more influential diseases in primary care from the patient's perspective.

To deliver patient-specific advice at the time and place of a consultation is an important contribution to improving clinician performance. Using computer-based decision support on the basis of clinical pathways is a promising strategy to achieve this goal. Thereby integration of IT applications into the clinical workflow is a core precondition for success. User acceptance and usability play a critical role: additional effort has to be balanced with enough benefit for the users and interaction design and evaluation should be handled as an intertwined, continuous process. Experiences from routine use of an online surgical pathway at Marburg University Medical Center show that it is possible to successfully address this issue by seamlessly integrating patient-specific pathway recommendations with documentation tasks which have to be done anyway, by substantially reusing entered data to accelerate routine tasks (e.g. by automatically generating orders and reports), and by continuously and systematically monitoring pathway conformance and documentation quality.

Background: Bronchopulmonary disease due to inhalation of smoke from open woodfires represents a major health problem in developing countries. Due to increasing migration such patients also present to medical services in Europe., Case Report and Discussion: An 84-year-old Afghan housewife who never smoked nor has a history of exposure to inorganic dusts, presents with chronic obstructive pulmonary disease (COPD) in association with bronchial anthracosis and stenosis of a bronchus. The complaints are found to be caused by chronic inhalation of smoke from an open woodfire which was used for cooking. The main complaints of "woodsmoke-associated lung disease" are cough und dyspnea with bronchial obstruction. Radiology and bronchoscopy usually reveal changes which are similar to pneumoconiosis of miners but without patients' relevant exposure. There is a frequent association of anthracotic bronchial stenosis and infection with tuberculosis., Conclusion: Since patients rarely recognize the risks of woodsmoke inhalation, they hardly report their exposure. Thus, the anamnesis is crucial to establish the right diagnosis and guide the patient to the appropriate diagnostic and therapeutic procedures.

Clinical pathways are an effective instrument to decrease undesired practice variability and improve clinician performance. IT applications embedded into clinical routine work can help to increase pathway compliance. Successfully implementing such applications requires both a responsive IT infrastructure and a participatory and iterative design process aimed at achieving user acceptance and usability. Experiences from the implementation and iterative improvement of an online surgical pathway at Marburg University Medical Centre have shown that pathway conformance actually could be improved by the use of IT. An analysis of the iterative design process has shown that future pathway projects can benefit from the lessons learned during this project. Based on these lessons a method for developing well adapted interaction mechanisms is presented, which is aimed at improving process alignment. Our goal is to build up a library of tested reusable components to reduce the number of iterations for pathway implementation.

Family medicine remains strongly influenced by reactive medicine ('tyranny of the urgent') and the fragmentation of healthcare associated with it. In the first part of the present article the increasing practical and economic relevance of chronic diseases and multimorbidity were analyzed as a fundamental challenge for primary care and family medicine in particular. Part two describes a forward-looking approach to guidelines and special tools which are able to guide and support future healthcare tasks of general practice. Wagner's Chronic Care Model, which was developed on the basis of numerous controlled studies, integrates empirical results, theoretical ideas and real experience within a comprehensive concept for the treatment of chronic diseases. The model focuses on the'productive interaction' between an active patient and a proactive practice team. The various elements of the model help to better understand healthcare in general practices, for example by establishing reminder and recall systems by means of a structured reorganization, through patient registers, the implementation of consultation hours for chronically ill patients as well as patient training. 'Case management' is essential to the success of structured care. Taking care of patients with major depression as an example, it is demonstrated how case management through practice assistants in general practices enables the individual needs of chronically ill patients to be better taken into account. The professionalism of the practice team with new roles and task sharing as well as the implementation of modern strategies for the care of chronically ill patients provide a new chance and a sharpened profile for general practices of the future.

Chronic diseases and multimorbidity are becoming a fundamental challenge for primary care which already requires a very high input of resources. Due to their broad range and continuity, general practices play a major role, but are poorly prepared to succeed in the structured healthcare of chronically ill patients. The reality of care in everyday practice is primarily characterized by the 'tyranny of the urgent', and such a reaction to acute problems leads to noticeable deficits in permanent care. Part one of a two-part article series asks to what extent demographic changes and medical progress are responsible for this development. Meanwhile, a large quantity of empirical evidence indicates that results improve when case management is implemented for chronically ill patients. Though disease management programs are being increasingly established in Germany, many general practices are only poorly prepared for their tangible implementation in everyday routine. The comparison of two case studies shows how the primary care of chronically ill patients might look like in the future. On the basis of both scientific evidence and the globally acknowledged 'Chronic Care Model', part two of the article looks at sustainable strategies and special tools which allow for an adequate care of chronically ill patients in general practice.

Background: Depression is a disorder with high prevalence in primary health care and a significant burden of illness. The delivery of health care for depression, as well as other chronic illnesses, has been criticized for several reasons and new strategies to address the needs of these illnesses have been advocated. Case management is a patient-centered approach which has shown efficacy in the treatment of depression in highly organized Health Maintenance Organization (HMO) settings and which might also be effective in other, less structured settings., Methods/design: PRoMPT (PRimary care Monitoring for depressive Patients Trial) is a cluster randomised controlled trial with General Practice (GP) as the unit of randomisation. The aim of the study is to evaluate a GP applied case-management for patients with major depressive disorder. 70 GPs were randomised either to intervention group or to control group with the control group delivering usual care. Each GP will include 10 patients suffering from major depressive disorder according to the DSM-IV criteria. The intervention group will receive treatment based on standardized guidelines and monthly telephone monitoring from a trained practice nurse. The nurse investigates the patient's status concerning the MDD criteria, his adherence to GPs prescriptions, possible side effects of medication, and treatment goal attainment. The control group receives usual care--including recommended guidelines. Main outcome measure is the cumulative score of the section depressive disorders (PHQ-9) from the German version of the Prime MD Patient Health Questionnaire (PHQ-D). Secondary outcome measures are the Beck-Depression-Inventory, self-reported adherence (adapted from Moriskey) and the SF-36. In addition, data are collected about patients' satisfaction (EUROPEP-tool), medication, health care utilization, comorbidity, suicide attempts and days out of work. The study comprises three assessment times: baseline (T0) , follow-up after 6 months (T1) and follow-up after 12 months (T2)., Discussion: Depression is now recognized as a disorder with a high prevalence in primary care but with insufficient treatment response. Case management seems to be a promising intervention which has the potential to bridge the gap of the usually time-limited and fragmented provision of care. Case management has been proven to be effective in several studies but its application in the private general medical practice setting remains unclear.

In order to obtain a proper knowledge base in primary care, a form of electronic patient record is needed that takes into account the specific characteristics of the doctor-patient encounter, the patient population, the presentation of diseases and the associated prevalences. However, in real life this has not happened for several reasons. For the most part, existing patient records are determined by invoicing requirements rather than by endeavours to meet the intrinsic needs of primary care. CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) is an ambitious scientific project in Germany to establish a system for adequate record keeping and analysis in primary care. Based on a classification system designed for the special situation of primary care, a scientific network is being established consisting of participating surgeries, general practitioners, computer scientists and statisticians. The project is supported by the German Federal Ministry of Education and Research. The aims are strictly scientific and the underlying hypothesis is that the knowledge-gaining process can be accelerated by combining the experience of many, especially with respect to complex interactions of factors and the analysis of rare events. Aside from maintaining a morbidity registry, within the CONTENT framework various prospective and retrospective studies on particular epidemiological and health economic research topics will be conducted.

Background: Patient education programmes will be a mandatory part of the new legislation on disease management programmes for chronic diseases in Germany. Today, only little is known about the number, variety and effectiveness of implemented patient education programmes in Germany., Methods: 176 potential providers of patient education programmes were identified by literature search, Internet search, and interviews with health education experts. We developed a semi-structured questionnaire. Assessment of content and quality was conducted in two steps by using defined criteria of the Co-ordinating Committee, the Head Association of the statutory health insurances and the respective Medical Associations: the first step was to check whether the programme had a structured teaching concept and whether all requirements for education with respect to a given disease had been taken into account. In the second step, we used balance sheets for reviewing the strengths and weaknesses of the programmes., Results: 49 providers handed in 95 pa tient education programmes for assess ment. Due to formal mistakes only 91 programmes could be analysed. 49 programmes failed the criteria of the first assessment step. For the remaining 42 patient education programmes balance sheets were prepared. Areas of the most frequent deficiencies included: lack of scientific evaluation of the effectiveness of the programme, lack of transparency of cost data, and quality improvement activities., Conclusions: For the purpose of a nation-wide implementation of disease management programmes the existing patient education programmes in Germany need to be further improved. Single examples demonstrated that the accessible criteria of self-management are not sufficient for the evaluation of already established patient education programmes.

The evaluation of disease management programmes is necessary and has been made obligatory in Germany by the Fifth Book of Social Code. So far there has been extensive ambiguity as regards the precise definition of suitable strategies for the evaluation. Considering the scientific evaluation of the diabetes contract in North-Rhine current deficits of the evaluation of already existing programmes for chronically ill patients are exemplarily described. On the basis of international experience reasonable demands are discussed that ought to be accomplished when evaluating the effectiveness and benefit of the programmes. Taking the British Medical Research Council as an example, a four-step model will be suggested as a loophole in the methodological dilemma of varying suitable study designs, which allows for the adequate evaluation of even complex interventions.

General practice is distinguished particularly by complex patient problems and generic competencies to act and counsel as a family practitioner. Guidelines which are only centered on clinical topics like diagnoses, treatments etc. are not sufficient to support action and decision in general practice. The article proposes the concept of generic guidelines (basic guidelines) for family medicine. A need for basic guidelines in general practice is established in three areas: 1) cross sectional patient problems (e.g. care for immigrants, common strain and distress, counselling of screening procedures), 2) basic skills and strategies in family practice (e.g. problem-oriented consultation, home visits, patient information and informed consent), and 3) practice management and documentation. The development of generic guidelines seems to be difficult as the efforts to evidence-based professional practice are only recently started, but this is matched by the high importance of guidance for general practice, and certain concepts of family medicine support it. It is concluded that the development of basic guidelines in general practice will have a considerable impact on structuring the framework and fostering the quality improvement of general practice.

Research Question: To study the attitudes of ambulatory care physicians towards quality improvement, the intentions to join quality circles (QCs, peer review groups) and the expectations directed towards them., Methods/setting: Survey with a five-page questionnaire posted to all ambulatory care physicians in the German states of Saxony-Anhalt (n = 3139) and Bremen (n = 1131)., Results: Response rates were 61.8% in Saxony-Anhalt and 41.7% in Bremen. 2412 questionnaires were available in this largest survey on that topic in Germany. Necessity of quality improvement (QI) in ambulatory care was approved by the majority of the respondents (1.7 on a 5-point Lickert scale). Concerns existed about a rise in control and the risk of abuse of QI measures. 56.4% in Saxony-Anhalt and 52.3% in Bremen had the intention to join a QC. Motives and impediments of participation in QCs were investigated by content analysis. A causal dominance analysis was performed to identify the key elements for the decision to participate. The main benefits of QC-participation were expected as assistance in daily practice and exchange of experiences. The major obstacles were professional and private duties, fear of control and inefficiency., Conclusions: Policies that could be adequate to rise motivations and tackle on widespread fears should be purposely adapted to the needs and expectations of the physicians.

Research Question: To study the habits of ambulatory care physicians in CME, and to investigate the motivating and negative experiences with different types of CME in Germany., Methods/setting: Survey with a five-page questionnaire posted to all ambulatory care physicians in the German states of Saxony-Anhalt (n = 3139) and Bremen (n = 1131)., Results: Response rates were 61.8% in Saxony-Anhalt and 41.7% in Bremen. 2412 questionnaires were available in this largest survey on that topic in Germany. Mean time devoted to CME was 4.6 hours per week, the respondents participated on the average at 14 CME-events per year. A content analysis was made to investigate positive and negative experiences. Practice orientation and personal exchange in small groups was appraised; criticism was mostly directed towards the efficiency and effectiveness of CME at large events (e.g. congresses)., Conclusions and Suggestions: Regionally performed surveys are able to guide the planning of CME about habits, wants and needs of the target group and may increase the attendance as well as the involvement. Motivating as well as critical experiences of the participants should be regarded more rigorously in the planning. Consideration can increase the quality and the impact of CME. This applies the more, when certification of the quality of CME and of individual CME-efforts are planned. This article will be followed in one of the next issues by a second from the same survey focusing on the attitudes of ambulatory care physicians towards quality improvement and their intentions to join quality circles (peer review groups).

The concept of evidence-based medicine yields to provide medical practice with actual scientific evidence, which raises from a comprehensive analysis of randomized controlled studies. The article reviews recent approaches, especially in the field of primary care (resp. family medicine) and points out the various outcomes of this concept within an analysis of the German system of medical instruction and continuing education. This approach, as all other components of medical education, shall prove its efficacy in further studies evaluating the impact on achievement in patient's care.