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Introduction: Clinically complex patients often require multiple medications. Polypharmacy is associated with inappropriate prescriptions, which may lead to negative outcomes. Few effective tools are available to help physicians optimise patient medication. This study assesses whether an electronic medication management support system (eMMa) reduces hospitalisation and mortality and improves prescription quality/safety in patients with polypharmacy., Methods and Analysis: Planned design: pragmatic, parallel cluster-randomised controlled trial; general practices as randomisation unit; patients as analysis unit. As practice recruitment was poor, we included additional data to our primary endpoint analysis for practices and quarters from October 2017 to March 2021. Since randomisation was performed in waves, final study design corresponds to a stepped-wedge design with open cohort and step-length of one quarter., Scope: general practices, Westphalia-Lippe (Germany), caring for BARMER health fund-covered patients., Population: patients (≥18 years) with polypharmacy (≥5 prescriptions)., Sample Size: initially, 32 patients from each of 539 practices were required for each study arm (17 200 patients/arm), but only 688 practices were randomised after 2 years of recruitment. Design change ensures that 80% power is nonetheless achieved., Intervention: complex intervention eMMa., Follow-Up: at least five quarters/cluster (practice). recruitment: practices recruited/randomised at different times; after follow-up, control group practices may access eMMa., Outcomes: primary endpoint is all-cause mortality and hospitalisation; secondary endpoints are number of potentially inappropriate medications, cause-specific hospitalisation preceded by high-risk prescribing and medication underuse., Statistical Analysis: primary and secondary outcomes are measured quarterly at patient level. A generalised linear mixed-effect model and repeated patient measurements are used to consider patient clusters within practices. Time and intervention group are considered fixed factors; variation between practices and patients is fitted as random effects. Intention-to-treat principle is used to analyse primary and key secondary endpoints., Ethics and Dissemination: Trial approved by Ethics Commission of North-Rhine Medical Association. Results will be disseminated through workshops, peer-reviewed publications, local and international conferences., Trial Registration: NCT03430336. ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03430336)., Competing Interests: Competing interests: BSM, RK-M, AIG-G, RH, JK-N, PK-M, NT, TB, LD, BS, BF, PI, SS, TSD, AP, IM, UK, HP, WG, FMG, HJT, CM report grants from the German Federal Joint Committee during the conduct of the study. DG reports grants from BARMER during the conduct of the study and family member works for and holds shares of IT company involved in the project. SG works for and holds shares of IT company involved in the project. SH, RP, PG declare that they have no competing interests., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To explore factors that potentially impact external validation performance while developing and validating a prognostic model for hospital admissions (HAs) in complex older general practice patients., Study Design and Setting: Using individual participant data from four cluster-randomised trials conducted in the Netherlands and Germany, we used logistic regression to develop a prognostic model to predict all-cause HAs within a 6-month follow-up period. A stratified intercept was used to account for heterogeneity in baseline risk between the studies. The model was validated both internally and by using internal-external cross-validation (IECV)., Results: Prior HAs, physical components of the health-related quality of life comorbidity index, and medication-related variables were used in the final model. While achieving moderate discriminatory performance, internal bootstrap validation revealed a pronounced risk of overfitting. The results of the IECV, in which calibration was highly variable even after accounting for between-study heterogeneity, agreed with this finding. Heterogeneity was equally reflected in differing baseline risk, predictor effects and absolute risk predictions., Conclusions: Predictor effect heterogeneity and differing baseline risk can explain the limited external performance of HA prediction models. With such drivers known, model adjustments in external validation settings (eg, intercept recalibration, complete updating) can be applied more purposefully., Trial Registration Number: PROSPERO id: CRD42018088129., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The World Health Organization has called for more importance to be attached to the subject of patient safety in medical studies. However, teaching staff are unsure when the right time is to include this topic in existing medical school curricula. The aim of this article is to present the learning objectives, design and evaluation of a two-day elective on patient safety offered in the preclinical phase of medical studies at the Faculty of Medicine, University of Frankfurt am Main. To the best of our knowledge, no existing elective on safety culture has been provided at such an early stage of medical studies in Germany., Methods: After defining learning objectives and teaching methods, the safety culture elective was offered in the winter term 2019/20. Based on a questionnaire, a quantitative and qualitative evaluation of the students' acceptance of the elective was carried out. We also sought to investigate whether group role-play was considered an effective means of communicating the teaching content. Acceptance and rejection of the elective were evaluated on a six-point Likert scale., Results: The resulting elective, consisting of topical input via film, an introductory speech, role-play and discussions, is presented. Nineteen students in the preclinical phase of their medical studies took part. Overall, the quantitative and qualitative evaluation delivered positive results (1.2±0.5), and the topic was perceived to very important. The students considered the didactic implementation and the learning objectives to be very good, and they became acquainted with different sources of error., Discussion: The preclinical elective would appear to be suitable for demonstrating the importance of medical safety to medical students and teaching them how to deal with the topic constructively. It can be viewed as a best-practice example for the development of comparable learning formats at medical faculties., Conclusion: The results show that the preclinical phase is a suitable time to illustrate the importance of the subject of patient safety during medical studies., (Copyright © 2021. Published by Elsevier GmbH.)

The prevalence of multimorbidity and polypharmacy increases significantly with age and are associated with negative health consequences. However, most current interventions to optimize medication have failed to show significant effects on patient-relevant outcomes. This may be due to ineffectiveness of interventions themselves but may also reflect other factors: insufficient sample sizes, heterogeneity of population. To address this issue, the international PROPERmed collaboration was set up to obtain/synthesize individual participant data (IPD) from five cluster-randomized trials. The trials took place in Germany and The Netherlands and aimed to optimize medication in older general practice patients with chronic illness. PROPERmed is the first database of IPD to be drawn from multiple trials in this patient population and setting. It offers the opportunity to derive prognostic models with increased statistical power for prediction of patient-relevant outcomes resulting from the interplay of multimorbidity and polypharmacy. This may help patients from this heterogeneous group to be stratified according to risk and enable clinicians to identify patients that are likely to benefit most from resource/time-intensive interventions. The aim of this manuscript is to describe the rationale behind PROPERmed collaboration, characteristics of the included studies/participants, development of the harmonized IPD database and challenges faced during this process., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objectives: To develop and validate a prognostic model to predict deterioration in health-related quality of life (dHRQoL) in older general practice patients with at least one chronic condition and one chronic prescription., Study Design and Setting: We used individual participant data from five cluster-randomized trials conducted in the Netherlands and Germany to predict dHRQoL, defined as a decrease in EQ-5D-3 L index score of ≥5% after 6-month follow-up in logistic regression models with stratified intercepts to account for between-study heterogeneity. The model was validated internally and by using internal-external cross-validation (IECV)., Results: In 3,582 patients with complete data, of whom 1,046 (29.2%) showed deterioration in HRQoL, and 12/87 variables were selected that were related to single (chronic) conditions, inappropriate medication, medication underuse, functional status, well-being, and HRQoL. Bootstrap internal validation showed a C-statistic of 0.71 (0.69 to 0.72) and a calibration slope of 0.88 (0.78 to 0.98). In the IECV loop, the model provided a pooled C-statistic of 0.68 (0.65 to 0.70) and calibration-in-the-large of 0 (-0.13 to 0.13). HRQoL/functionality had the strongest prognostic value., Conclusion: The model performed well in terms of discrimination, calibration, and generalizability and might help clinicians identify older patients at high risk of dHRQoL., Registration: PROSPERO ID: CRD42018088129., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The German healthcare system is struggling with fragmentation of care in the face of an increasing shortage of general practitioners and allied health professionals, and the time-demanding healthcare needs of an aging, multimorbid patient population. Innovative interprofessional, intersectoral models of care are required to ensure adequate access to primary care across a variety of rural and urban settings into the foreseeable future. A team approach to care of the complex multimorbid patient population appears particularly suitable in attracting and retaining the next generation of healthcare professionals, including general practitioners. In 2014, the German Advisory Council on the Assessment of Developments in the Health Care System highlighted the importance of regional, integrated care with community-based primary care centres at its core, providing comprehensive, population-based, patient-centred primary care with adequate access to general practitioners for a given geographical area. Such centres exist already in Ontario, Canada; within Family Health Teams (FHT), family physicians work hand-in-hand with pharmacists, nurses, nurse practitioners, social workers, and other allied health professionals. In this article, the Canadian model of FHT will be introduced and we will discuss which components could be adapted to suit the German primary care system., Competing Interests: FMG ist seit 2007 Mitglied und seit 2012 Vorsitzender des Sachverständigenrates zur Begutachtung der Entwicklung im Gesundheitswesen. AE hat an der Erstellung der SVR-Gutachten der Jahre 2009, 2012 und 2014 mitgearbeitet. TP ist ärztliche Leiterin eines akademischen Family Health Teams in Toronto, Ontario, Kanada. Die Autoren geben an, dass kein Interessenkonflikt gemäß der ICMJE Recommendations (Stand Dezember 2016) besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Guidelines recommend early colonoscopy for individuals with a positive family history of colorectal cancer (CRC), but little is known about the utilization of colonoscopy and the frequency of colorectal neoplasms among younger affected individuals in Germany. The aim of this study was to determine the utilization of colonoscopy and the frequency of colorectal neoplasms in this risk group. We conducted a cross-sectional study in a general practice setting. Patients aged 40-54 years with at least one first-degree relative with CRC were identified, counseled on their increased risk, and referred to colonoscopy if they decided to undergo this procedure. We assessed the reported utilization of colonoscopy before study participation with a questionnaire and obtained results of colonoscopies performed during the study period from colonoscopy reports. Out of 484 patients with a positive family history of CRC, 191 (39.5%) fulfilled the inclusion criteria and participated in the study: 54% reported that at least one colonoscopy had been performed before study participation. Out of 191 participants, 86 (45%) underwent a colonoscopy during study period. No CRC was found, but 16.3% had any adenoma, and 7.0% had advanced adenomas. Overall, 155 (82%) study participants underwent a colonoscopy either before or during the study period. The utilization of colonoscopies among participants was remarkably high even before study participation. This rate increased up to 82% after counseling by general practitioners. A relevant number of participants had (advanced) adenomas. It appears worthwhile to involve general practitioners in identifying and counseling younger individuals with familial risk for CRC.

Introduction: Due to the growing shortage of general practitioners (GPs), solutions are being sought to improve the structure and attraction of specialist training in general practice. In 2012, the Competence Center for Specialist Training in General Practice was set up in the federal state of Hesse, Germany, in order to provide a seminar- and mentoring program to complement standard specialist training. The present paper examines whether the mentoring program, which was based on needs assessment, supports doctors in training (DiT) to become specialists in general practice., Methods: A mixed-methods design was used for the evaluation of the mentoring program. The pilot cohort monitored in this study was surveyed using a guideline-based interview. The cohort consisted of the first cohort of participants in the Specialist Training Academy (n=21), which was divided into two mentoring groups. Responses were evaluated with the help of the MAXQDA 11 program and qualitative content analysis to structure content. Furthermore, all 16 group meetings were assessed by means of evaluation sheets (n=132) and analyzed descriptively using the statistics program SPSS (IBM statistics, Version 20)., Results: Of the 21 DiTs of the total sample that took part in the interviews, two-thirds of the surveyed mentees were female (71.4 %). The mentoring and seminar programs encouraged the mentees in their decision for and their identification with specialist training in general practice and helped them overcome any doubts about their choice. The decisive factors in the mentoring process were interacting with like-minded people, discussing organizational questions and having a fixed contact person in case of questions and doubts. The evaluation sheets made it clear that the mentees regarded the mentoring as supportive (99.3 % positive). Compared to the other mentoring group, participants in the one group felt they were better supported by mentoring, found the interaction with other DiTs more helpful, the interaction between mentors and the group exactly right, and the topics they discussed more relevant., Conclusion: The provided mentoring program fulfilled the expectations of the DiTs in general practice. Combined with the Specialist Training Academy's seminar program, the two programs complement each other and are an important step towards making specialist training in general practice more attractive., (Copyright © 2018. Published by Elsevier GmbH.)

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.

Introduction: The combination of an ageing population and unequal distribution of healthcare capacity between rural and urban regions requires the development of innovative healthcare models, especially in rural areas, thus increasing the need to involve community representatives. The aim of this study was to ascertain the need for support and advice among municipalities and family doctors planning and implementing regional projects to ensure the provision of healthcare, and to develop a support and consultancy service on that basis., Methods: Using semi-structured telephone interviews, 16 local representatives of the target groups (representatives from rural districts, mayors of rural municipalities and communities, doctors in private practice) were asked to identify the kind of support and advice they needed. The interviews were evaluated using the framework approach, a form of qualitative content analysis, and the results used to develop modules of a support and consultancy service. We discussed and finalized the concept during several workshops involving different representatives of the target groups (another 36 general practitioners, 19 mayors and representatives from rural districts)., Results: After taking into account the expressed need for advice and support, the developed consultancy service included the following modules: local situation/needs analysis, financial support options (e. g., grant application), concept/project development (including presentation of best practice examples), networks, assessment and evaluation, junior staff recruitment and introduction to other experts (for legal or IT-related advice, mediation, etc.)., Discussion: The study showed that local representatives have a substantial need for advice and support for which no nationwide consultancy service is yet available. Future practice tests should establish the extent to which local participants and projects can benefit from the consultancy service we have developed., (Copyright © 2018. Published by Elsevier GmbH.)

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.

Introduction: Safeguarding country-wide health care in Germany requires innovative ideas: a shortage of skilled staff among medical professionals and in long-term care on the one hand contrasts with an increasing number of multi-morbid elderly patients on the other hand. In the "Innovative Health Care Models" project sponsored by the Robert Bosch Foundation a nationwide status review and systematization of innovative approaches to health care was conducted, along with an analysis of the factors that promote or hinder the implementation of a health care model, and a study of the conditions that must be satisfied if successful concepts are to be transferred to other regions., Methods: After identifying innovative and successfully implemented health care models, data on success factors and barriers for implementation as well as data on conditions of their transferability to other regions were collected during structured telephone interviews and entered into a specifically developed database. Content analysis was used to qualitatively evaluate the interviews., Results: Interviews with 65 representatives of successfully implemented models with differing organizational structures and priorities were conducted and evaluated. Success factors and barriers were most obvious in the fields of leadership, readiness to participate, relational aspects, personality traits, cooperation and communication, resources and organizational and structural factors., Discussion: Various regionally linked health care concepts already exist throughout Germany. The barriers, success factors and conditions influencing the transferability of a model to other regions are largely independent of the type of organization. The success of a model is determined by adequate personal and financial resources, sound organizational structures and external support from political and funding bodies., (Copyright © 2016. Published by Elsevier GmbH.)

In Germany, medical doctorates are regularly criticized for their insufficient quality. In order to improve the quality of doctorates and to support doctoral candidates, a department-wide doctoral research program was established at the Goethe University of Frankfurt am Main in 2011 taking into account the practical needs of doctoral students at the School of Medicine. The program development proceeded in several steps: in the first step (2009/2010), a pilot study with eleven doctoral candidates was carried out at the Institute of General Practice. Their ratings of the perceived relevance and their own knowledge of 15 topics of scientific work were used to identify a provisional need for support. Subsequently an interdisciplinary panel of experts established the program throughout the faculty. Since its implementation, a requirements analysis in the form of questionnaires has been continuously carried out in order to assess the doctoral students' prior knowledge and their preferences expressed. At the same time, systematic searches for support programs in other medical fields have been conducted throughout Germany on several occasions. On the basis of the pilot study, the research results and the expert panel discussions the following topics were found to be particularly relevant: principles of good scientific practice, literature search, reference management, organization and structure of a doctoral thesis, formatting of Word documents, clinical epidemiology and data management. A specific, stepwise development process was used to design a concept for the faculty of medicine that pays close attention to the knowledge and interests of doctoral candidates. The establishment of the doctoral research program in Frankfurt and the results of its evaluation are presented in a second article (Paulitsch et al., 2016)., (Copyright © 2016. Published by Elsevier GmbH.)

The poor quality of medical dissertations has repeatedly been criticized by scientific and higher education institutions. In medicine, doctoral students rated their own knowledge of fundamental scientific issues as low. The establishment of a doctoral research program could solve this problem. However, no scientific paper has yet been published showing how such support programs should be designed. Here we present an example of such a design on the basis of the doctoral research program which the Faculty of Medicine at the Goethe University, Frankfurt am Main, established in 2011. Using requirements analyses, eight basic courses have been developed that can be attended separately but are considered to contain essential information for all doctorates. To ensure a high quality of the doctoral research program and to take into account the needs of doctoral students, both the individual courses and the doctoral research program as a whole were evaluated. The doctoral research program has been very well accepted by doctoral students, with a total of 449 doctoral students, who attended an average of five courses from 2011 to 2014. The total number of participants amounted to 2,302 in 159 courses. The results of the evaluation show that on average all the basic courses were considered to be 'good' or 'very good'. After participating in eight courses, the doctoral students' overall evaluation of the doctoral research program resulted in a very positive assessment of the overall concept. Further aspects, such as the examination of the impact of participation in the doctoral research program on dissertation quality, are pending. Due to the positive feedback from participants, we recommend that other faculties establish similar programs., (Copyright © 2016. Published by Elsevier GmbH.)

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: The contract covering family doctor-centred health care (HzV) in Baden-Wuerttemberg supports and remunerates the deployment of specially trained health care assistants (VERAHs). It is as yet unknown to what extent VERAHs are actually deployed in HzV, what the focus of their work is, what changes and shifts in responsibility have resulted in the practice team, and whether they have relieved the burden on family doctors., Method: A full survey of all VERAHs in HzV practices in Baden-Wuerttemberg was conducted using a questionnaire (response rate over 32 %, N = 294). The questions aimed to gather information on how often and where VERAHs were deployed and on observed changes in their fields of responsibility. The family doctors employing VERAHs also received a questionnaire containing questions related to the changes observed, and additional questions on the delegation of responsibilities to VERAHs., Results: To an increasing extent, VERAHs take on responsibilities that directly involve the patient, such as home visits agreed on with the doctor, vaccination and drug management, wound management and case management. Thus they take on tasks traditionally reserved for doctors. Both family doctors and VERAHs said that patient health care has improved and that the use of VERAHs helps doctors save time., Conclusions: The deployment of VERAHs in family doctor-centred health care leads to the redistribution of responsibilities in the practice and thus relieves physician burden. Chronically ill patients benefit from continuous care and an additional contact person. Health care assistants benefit from new career options., (Copyright © 2013. Published by Elsevier GmbH.)

Background and Research Question: Pursuant to Section 73b, volume V of the German Social Security Code (SGB V), the agreement on family doctor-centred care (HzV), which went into effect in Baden-Wuerttemberg on July 1, 2008, provides for spatially inclusive and comprehensive medical coverage. The most important elements of the agreement are: the voluntary registration of family practices and patients, the strengthening of the coordinative function of family practices, the fulfilment of certain training, quality and qualification requirements, the standardised remuneration system and the use of specified practice software for billing and the prescription of drugs. The aim of this complex intervention is to strengthen family medicine, improve health care, in particular for patients with chronic disease, and to limit primary health care costs while improving its quality wherever possible. This first controlled nationwide evaluation examines the question whether these objectives were met in the early phase (2008 to 2011) and, if so, to what extent., Method: Four work packages were defined: 1. differences in health care processes (utilisation, contact to specialists, hospitalisations, drug prescriptions); 2. developments in practice teams and of patient satisfaction; 3. deployment of specially trained health care assistants in family practices (VERAH); 4. implementation of the DEGAM (German Society of General Practice and Family Medicine) heart failure guideline. To the extent that it was possible to use the statutory health insurance company AOK Baden-Wuerttemberg's routine data, an adjusted comparison of the target variables was made for HzV- and non-HzV-insured patients between the first and second or between the third and fourth quarters of 2008, and between the first and second or third and fourth quarters of 2010., Results: HzV participants were older, had a higher disease burden (Charlson Index 1.45 vs. 1.19), and were attended to more intensively than patients receiving routine care (1.7 more contacts with the family doctor per half-year). The number of non-referred contacts to specialists fell by 12.5 %. An increase in the number of referrals and hospitalisations was not observed. Participation in structured treatment programmes was substantially higher, e.g. 15 % vs. 7.5 % (non-HzV) in DMP diabetes mellitus Type 2. In the HzV, the rise in medication costs due to family physician prescriptions (ignoring the effect of discount agreements) was lower by 2.5 %, and the me-too rate was significantly lower. Higher remuneration contributed to greater satisfaction among HzV physicians despite the perceived increase in the workload. In a survey of 2,535 patients HzV participants showed a high rate of patient satisfaction overall, and physical examinations and services aimed at preventing illness were regarded particularly favourably. A survey of 294 VERAH showed that they more often accepted patient-related tasks such as home visits, geriatric assessments, patient training, and vaccination and preventive management. Family physicians were prepared to delegate responsibilities and, as a result, felt disburdened. In accordance with the latest DEGAM guideline patients with heart failure enjoyed an improvement to an overall high level in their drug therapies with ACE inhibitors, AT1 antagonists and beta blockers. Further improvement resulting from medical quality circles and training was not observed., Discussion and Conclusions: The results confirm the findings of international studies: in particular, HzV benefits patients with chronic disease, and patients receive improved health care when they participate in the Baden-Wuerttemberg HzV. All four evaluation modules reveal that changes towards the intended direction are taking place. Family doctors assumed more responsibility for coordination. These findings reflect the early start-up phase and the development phase of HzV in Baden-Wuerttemberg. These effects, together with those of other prioritised topics, will be continuously monitored as part of an accompanying evaluation process., (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.)

Objectives: Case management by health care assistants in small primary care practices has proven effective in improving depression symptoms in depressive patients. Resource consumption and costs of this intervention have not been evaluated yet., Methods: Health care assistants and general practitioners of 15 participating practices were interviewed for intervention-related time expenditures. Intervention costs were based on individual labour costs., Results: The annual time spent was 6.3 h per patient for health care assistants and 3.6 h for general practitioners (mean 8.9 patients per practice). The case management caused costs of € 277 per patient and year., Conclusions: A telephone-based case management as add-on therapy improves quality of primary care depression therapy while causing only moderate costs for health care providers., (© Georg Thieme Verlag KG Stuttgart · New York.)

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.

Background: Safety climate comprises shared perceptions of safety issues and is a visible feature of a safety culture. Usually self-report questionnaires are used to assess a safety climate. The aim of this project was to develop the first German questionnaire for the assessment of the patient safety climate in general practices., Methods: The development of the instrument was based on a US questionnaire. The ambulatory care setting differs considerably between the two countries in terms of organisational and economic issues as well as the number and variety of healthcare professionals. The process of adaptation therefore required the following steps: 1) translation of the Safety Attitudes Questionnaire, ambulatory version (SAQ-A), 2) interviews with experts on quality improvement in order to evaluate the comprehensiveness and relevance of the SAQ-A in the new context, 3) revision of items, 4) pretesting of the preliminary version on a sample of healthcare professionals from general practices and 5) a final revision., Results: The "Fragebogen zum Sicherheitsklima in Hausarztpraxen" (FraSiK) is a questionnaire consisting of 68 items, 36 of which were adapted from the original. Altogether, 32 items, relating to the involvement of patients, communication, education and training, error management and dealing with regulations were added., Conclusion: Substantial changes were made to the original questionnaire and items added in order to obtain an appropriate instrument for the assessment of the content and relevance of patient safety culture in the socio-cultural context of German general practices.

Since 2002 some of the world's largest disease management programs have been launched in Germany--initially for type II diabetes and coronary heart disease--with approximately 5 million eligible insured persons and (in 2005) 2.04 million registered participants. The programs were not piloted prior to their start, and the prescribed statutory evaluation cannot be expected to result in an effectiveness validation. The article describes the development of a study protocol for a randomized controlled trial. It also discusses methodological problems, in particular the definition of primary target criteria, the guarantee of a 'naturalistic' intensity of intervention, and the creation of a control group during nation-wide implementation. Due to lacking support from the stakeholders the proposed randomized trial could not be implemented. Its design, however, allows the required standards for the program evaluation to be specified.

Background: In Germany, primary healthcare for patients with chronic diseases needs to be improved. Taking the example of depression, congestive heart failure, diabetes and diseases of the musculoskeletal system we analyzed to which extent the 'Chronic Care Model' allows for improvements., Methods: Diagnosis-specific health assessment; adaptation of the 'Chronic Care Model' to the German healthcare system; peer reviewed discussions of the potentials for improving primary care of the chronically ill. RESULTS/DISCUSSION OF THE HEALTHCARE SITUATION: 1) Diagnosis and therapy of chronic diseases comply insufficiently with the evidence. 2) Patients are too passive and/or receive only little effective support. 3) Treatments are often uncoordinated and fragmented. 4) The follow-up of treatment results is often neglected. 5) Approaches to indicated diseases are promising., Conclusions: The'Chronic Care Model' could improve chronic care in Germany. Disease Management Programs (DMP) should amend multimorbidity and individual healthcare and/or facilitate implementation in general practice.

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: Structured and regular monitoring and/or case management support treatment continuity of patients with depression in primary care. Central tools are questionnaires with stratified operating instructions. Questions should be geared towards treatment relevance in primary care and identify clinical parameters in a reliable and valid manner and in due time. Stratified information transfer to the general practitioner should be objective to ensure patient-related communication in the practice team., Method: Development of a draft tool based on evidence-based guidelines, peer-reviewed pre-test, practice test among users., Result: The Depression Monitoring List (DeMoL) with integrated PHQ-D for interviews with depressive patients to be conducted by practice assistants assesses 1.)'clinical diagnosis' and 2.) 'patient adherence' and 3.) governs the information flow in the practice via a 'robot scheme'. Users (doctors and practice assistants) evaluated the tool as practicable and relevant for patient care in family practices. Experiences gained can also be used for the treatment of other chronic diseases.

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.

Background and Objectives: Almost every tenth patient of a general practitioner (GP) suffers from depression. However, only 20-25% of these patients are correctly diagnosed during a GP consultation. How do international guidelines for depression in primary care initiate structured diagnostic procedures for depression?, Methods: We performed a systematic literature search on guidelines for the diagnosis of depression with focus on primary care. The quality of the guidelines was rated according to base of evidence, existence of pilot studies, data on implementation, presentation and specificity for primary care settings, and conflict of interest. We also screened whether and how the guidelines comment on the initiation of structured diagnostic procedures for depression., Results: Of the 22 identified guidelines, only 15 address primary care. Only 3 of these were tested in pilot studies, 3 provided data on implementation, 9 were evidence-based. The best guideline (6 out of 6 criteria met) is available in Dutch and established for The Netherlands only. We ranked the guidelines from NHG, VHA and ICSI as very good in terms of methodological quality. They present 'red flags' that initiate structured diagnostic procedures by 'opportunistic screening'. This is followed by the application of a self-rating instrument and an ICD-10-based diagnostic checklist identifying up to 98% of all patients with depression in a given consultation time of 10 minutes on average., Conclusion: Based on these criteria a national diagnostic depression guideline should, from our point of view, explicitly include keys such as "red flags" for the initiation of structured diagnostic procedures.

The implementation of the disease management programme (DMP) for asthma and COPD in the German health system in 2005 requires an optimal and evidence-based work-up of patients by general practitioners in routine daily practice. The German and international guidelines for COPD do not provide recommendations for a stepwise diagnostic work-up in primary care. Therefore, an evidence-based algorithm was developed for a stepwise diagnosis of COPD and its different stages in general practice, based on national and foreign guidelines that provide specific advice on diagnostic procedures.

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.

Background: Congestive Heart Failure (CHF) is becoming the most serious cardiac health problem after coronary heart disease (CHD). But at present, service offered to CHF patients are flawed because of the fragmentation and discontinuity of care. Case management (CM) takes responsibility for following up patients, for assessing symptoms and taking action when patients do not adhere to guideline based treatment or fail to improve. This review analyses the evidence of primary care based CM for patients with CHF., Methods: Searches in Medline using relevant MeSH terms and hand-searching were applied to identify relevant studies. We selected RCTs and pre-post studies focussing on patient-centred CM in ambulatory settings. A five-level score (simple to complex) was generated to describe interventions and compare results., Results: 23 of 462 identified studies (16 RCT, 7 others) that fulfilled our selection and quality criteria were included. We classified 15 studies as "complex" CM, i.e. they contained more than three elements of intervention, were strongly integrated with the process of care, involved a specialised nurse, and offered individual patient education. All studies examined the length of hospital stay: costs were investigated in 17, quality of life in 10 and mortality in 7 studies. Studies examining a "complex" CM demonstrated positive effects on mortality and quality of life in the 3-6 months of follow up. Studies with a follow up period of 12 to 18 months showed a reduction of hospital days., Conclusion: Especially "complex" models of CM for patients with CHF can be effective in a primary care setting. CM can prevent the fragmentation and discontinuity of care by strengthening a close contact between patient and health care provider.

In 2003, the German Ministry of Health will publish a legal document that will allow for the implementation of disease management programmes for asthma and COPD. Examination of German asthma guidelines reveals that they do not include recommendations for a stepwise diagnostic work-up of patients with relevant symptoms in general practice. Therefore an algorithm was developed for the diagnosis of asthma in general practice, based on both national and the most important foreign guidelines providing specific advice on diagnostic procedures.

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.

Exemplified by studies on the predictive value of standardised history taking of angina pectoris, part 2 of this contribution describes the different significance of medical diagnostics in dependency from different levels of the health care system (general practice, cardiologic drop-in clinic, university hospital). Because of different prevalences (pre-test probability) and in spite of exactly the same symptoms the probability of actual coronary heart disease is highly different. The specific post-test probability can be explained and calculated by Bayes' theorem. It becomes evident why general practitioners have to be cautious in adopting recommendations, if those recommendations are based on studies which were done with patients in specialised health care settings. As a consequence from the reflections and empirical findings presented, it becomes better comprehensible what general practice is not and which perspectives for research, education and practice are resulting.