Artificial Pancreas Systems for People With Type 2 Diabetes: Conception and Design of the European CLOSE Project.

In the last 10 years tremendous progress has been made in the development of artificial pancreas (AP) systems for people with type 1 diabetes (T1D). The pan-European consortium CLOSE (Automated Glu cose Contro l at H ome for People with Chronic Disea se) is aiming to develop integrated AP solutions (APplus) tailored to the needs of people with type 2 diabetes (T2D). APplus comprises a product and service package complementing the AP system by obligatory training as well as home visits and telemedical consultations on demand. Outcome predictors and performance indicators shall help to identify people who could benefit most from AP usage and facilitate the measurement of AP impact in diabetes care. In a first step CLOSE will establish a scalable APplus model case working at the interface between patients, homecare service providers, and payers in France. CLOSE will then scale up APplus by pursuing geographic distribution, targeting additional audiences, and enhancing AP functionalities and interconnectedness. By being part of the European Institute of Innovation and Technology (EIT) Health public-private partnership, CLOSE is committed to the EIT "knowledge triangle" pursuing the integrated advancement of technology, education, and business creation. Putting stakeholders, education, and impact into the center of APplus advancement is considered key for achieving wide AP use in T2D care.

[Topic identification for cross-sectoral quality assurance in stroke and TIA treatment]. / Themenerschließung für die sektorenübergreifende Qualitätssicherung der Versorgung bei Schlaganfall und TIA.

The development of cross-sectoral quality assurance programs usually requires extensive topic identification. Illustrated by the complex processes of care for stroke and transient ischemic attacks (TIAs), a method for comprehensive topic identification is presented. The first step involves a thorough literature search in terms of systematic reviews, health technology assessments, guidelines, studies into healthcare delivery and the use of specific instruments. Routine data as well as epidemiologic studies are used to analyze the reality of service provision. In addition, experts are consulted to gain expertise concerning deficits of care, approaches to quality assurance and experience with existing quality assurance programs. Furthermore individual patient experiences are collected to add the patients' perceptions of care. Because of the limitation on the regulatory scope of Book V of the German Social Code, which, in this case, was necessary, another source of information was the legal framework and its impact on rescue chain, acute treatment and rehabilitation. Existent quality management systems, accreditations and quality assurance programs in prevention, acute treatment and rehabilitation have been searched in order to avoid any overlap with existing measures. After identifying a total of 71 quality targets according to deficits of care, recommendations for care and expert opinions in primary and secondary prevention, rescue chain, acute treatment, rehabilitation and supply of assistive equipment and therapies, respectively, the usability of instruments was tested. These instruments included case documentation, patient surveys and routine data. 14 quality targets proved to be reproducible by these instruments and were included in the recommendations for a cross-sectoral quality assurance program for stroke and TIA.

Development of quality indicators and data assessment strategies for the prevention of central venous catheter-related bloodstream infections (CRBSI).

BACKGROUND: The number of catheter related bloodstream infections (CRBSI) could be reduced and the outcome improved if specific standards in the quality of care were maintained. Therefore, the development of quality assurance (QA) procedures was commissioned to be included in the national mandatory QA programme in Germany. METHODS: Indicators representing quality deficiencies and potential for improvement of quality in relation to prevention and management of central venous catheters (CVC) were developed by (1) evidence-based literature searches and the compiling of an indicator register; (2) a multi-professional expert panel including patient representatives who selected indicators from this register by using a modified RAND/UCLA Appropriateness Method; (3) defining methods for data assessment, risk adjustment and feedback of indicator results to service providers; and (4) consulting all relevant medical societies and other stakeholders with regard to the QA procedures that had been developed. RESULTS: Thirty-two indicators for CRBSI prevention and management were eventually approved by the expert panel. These indicators represent quality of care at predefined points with regard to indication, insertion and care of CVCs, management of sepsis, general hygiene and training of health care personnel. Fourteen indicators represent processes, together with 7 representing structures and 11 outcomes. For assessing these indicators, data was obtained from four sources: claims data from health insurance funds, routine claims data from hospital electronic information systems, case specific longitudinal documentation from service providers and cross-sectional annual assessment of structures. CONCLUSIONS: It was possible to develop indicators for mandatory QA procedures on CRBSI that take into account the different perspectives of all stakeholders involved. Despite efforts to use routine data for documentation wherever possible, most indicators required extra documentation.

Developing cross-sectoral quality assurance for cataract surgery in the statutory quality assurance program of the German health care system: Experiences and lessons learned.

Since 2001, statutory external quality assurance (QA) for hospital care has been in place in the German health system. In 2009, the decision was taken to expand it to cross-sectoral procedures. This novel and unprecedented form of national QA aims at (1) making the quality procedures comparable that are provided both in inpatient and outpatient care, (2) following-up outcomes of hospital care after patients' discharge and (3) measuring the quality of complex treatment chains across interfaces. As a pioneer procedure a QA procedure in cataract surgery QA was developed. Using this as an example, challenges of cross-sectoral QA are highlighted. These challenges relate, in particular, to three technical problems: triggering cases for documentation, following-up patients' after hospital discharge, and the burden of documentation in outpatient care. These problems resulted finally in the haltering of the development of the QA procedure. However, the experiences gained with this first development of cross-sectoral QA inspired the reorientation and further development of the field in Germany. Future cross-sectoral QA will rigorously aim at keeping burden of documentation small. It will draw data for QA mainly at three sources: routine data, patient surveys and peer reviews using indicators. Policy implications of this reorientation are discussed.

[Quality measurement using administrative data in mandatory quality assurance]. / Qualitätsmessung mit Routinedaten in der gesetzlichen Qualitätssicherung am Beispiel Dekubitusprophylaxe.

For several years, the use of administrative data in mandatory quality measurement has been requested by several stakeholders in Germany. Main advantages of using administrative data include the reduction of documentary expenditures and the possibility to perform longitudinal quality analyses across different healthcare units. After a short introduction, a brief overview of the current use of administrative data for mandatory quality assurance as well as current developments is given, which will then be further exemplified by decubital ulcer prophylaxis. By using administrative data coding expenditures in this clinical area could be reduced by nine million data fields. At the same time the population analysed was expanded resulting in a more than tenfold increase in potentially quality-relevant events. Finally, perspectives, further developments, possibilities as well as limits of quality measurement with administrative data are discussed.

Effectiveness of a quality management program in dental care practices.

BACKGROUND: Structured quality management is an important aspect for improving patient dental care outcomes, but reliable evidence to validate effects is lacking. We aimed to examine the effectiveness of a quality management program in primary dental care settings in Germany. METHODS: This was an exploratory study with a before-after-design. 45 dental care practices that had completed the European Practice Assessment (EPA) accreditation scheme twice (intervention group) were selected for the study. The mean interval between the before and after assessment was 36 months. The comparison group comprised of 56 dental practices that had undergone their first assessment simultaneously with follow-up assessment in the intervention group. Aggregated scores for five EPA domains: 'infrastructure', 'information', 'finance', 'quality and safety' and 'people' were calculated. RESULTS: In the intervention group, small non-significant improvements were found in the EPA domains. At follow-up, the intervention group had higher scores on EPA domains as compared with the comparison group (range of differences was 4.2 to 10.8 across domains). These differences were all significant in regression analyses, which controlled for relevant dental practice characteristics. CONCLUSIONS: Dental care practices that implemented a quality management program had better organizational quality in contrast to a comparison group. This may reflect both improvements in the intervention group and a selection effect of dental practices volunteering for the first round of EPA practice assessment.

[Current challenges of external quality assurance in the German healthcare system]. / Aktuelle Herausforderungen der externen Qualitätssicherung im deutschen Gesundheitswesen.

External quality assurance has three main aims: to make service provision in medicine and nursing comparable, to systematically identify deficits in service quality and to support the introduction of measures for quality improvement. This article reflects on three major developments in mandatory external quality assurance in the German healthcare system that took place during the last five years. These developments include the implementation of cross-sectoral quality assurance, the utilisation of new data sources and a new focus on quality deficits and practicability. The article highlights the challenges that come along with these developments.

Evaluating the quality of colorectal cancer care across the interface of healthcare sectors.

BACKGROUND: Colorectal cancer (CRC) has a high prevalence in western countries. Diagnosis and treatment of CRC is complex and requires multidisciplinary collaboration across the interface of health care sectors. In Germany, a new nationwide established program aims to provide quality information of healthcare delivery across different sectors. Within this context, this study describes the development of a set of quality indicators charting the whole pathway of CRC-care including data specifications that are necessary to operationalize these indicators before practice testing. METHODS: Indicators were developed following a systematic 10 step modified 'RAND/UCLA Appropriateness Method' which involved a multidisciplinary panel of thirteen participants. For each indicator in the final set, data specifications relating to sources of quality information, data collection procedures, analysis and feedback were described. RESULTS: The final indicator set included 52 indicators covering diagnostic procedures (11 indicators), therapeutic management (28 indicators) and follow-up (6 indicators). In addition, 7 indicators represented patient perspectives. Primary surgical tumor resection and pre-operative radiation (rectum carcinoma only) were perceived as most useful tracer procedures initiating quality data collection. To assess the quality of CRC care across sectors, various data sources were identified: medical records, administrative inpatient and outpatient data, sickness-funds billing code systems and patient survey. CONCLUSION: In Germany, a set of 52 quality indicators, covering necessary aspects across the interfaces and pathways relevant to CRC-care has been developed. Combining different sectors and sources of health care in quality assessment is an innovative and challenging approach but reflects better the reality of the patient pathway and experience of CRC-care.

[Does implementation of benchmarking in quality circles improve the quality of care of patients with asthma and reduce drug interaction?]. / Führt die Implementierung von offenem Benchmarking in datengestützten Qualitätszirkeln zur Verbesserung der hausärztlichen Versorgung bei Arzneimittelinteraktion und Asthma bronchiale?

OBJECTIVE: The purpose of this cluster-randomised controlled trial was to evaluate the efficacy of quality circles (QCs) working either with general data-based feedback or with an open benchmark within the field of asthma care and drug-drug interactions. METHODS: Twelve QCs, involving 96 general practitioners from 85 practices, were randomised. Six QCs worked with traditional anonymous feedback and six with an open benchmark. Two QC meetings supported with feedback reports were held covering the topics "drug-drug interactions" and "asthma"; in both cases discussions were guided by a trained moderator. Outcome measures included health-related quality of life and patient satisfaction with treatment, asthma severity and number of potentially inappropriate drug combinations as well as the general practitioners' satisfaction in relation to the performance of the QC. RESULTS: A significant improvement in the treatment of asthma was observed in both trial arms. However, there was only a slight improvement regarding inappropriate drug combinations. There were no relevant differences between the group with open benchmark (B-QC) and traditional quality circles (T-QC). The physicians' satisfaction with the QC performance was significantly higher in the T-QCs. CONCLUSION: General practitioners seem to take a critical perspective about open benchmarking in quality circles. Caution should be used when implementing benchmarking in a quality circle as it did not improve healthcare when compared to the traditional procedure with anonymised comparisons.

[Benchmarking in ambulatory care practices--The European Practice Assessment (EPA)]. / Benchmarking in der ambulanten Versorgung am Beispiel des Europäischen Praxisassessments (EPA).

The European Practice Assessment (EPA) is a comprehensive quality management which consists of 220 indicators covering 5 domains (infrastructure, people, information, finance, and quality and safety). The aim of the project presented was to evaluate EPA as an instrument for benchmarking in ambulatory care practices. A before-and-after design with a comparison group was chosen. One hundred and two practices conducted EPA at baseline (t1) and at the 3-year follow-up (t2). A further 209 practices began EPA at t2 (comparison group). Since both practice groups differed in several variables (age of GP, location and size of practice), a matched-pair design based on propensity scores was applied leading to a subgroup of 102 comparable practices (out of the 209 practices). Data analysis was carried out using Z scores of the EPA domains. The results showed significant improvements in all domains between t1 and t2 as well as between the comparison group and t2. Furthermore, the results demonstrate that the implementation of total quality management and the re-assessment of the EPA procedure can lead to significant improvements in almost all domains.

[Job satisfaction of general practitioners]. / Die Arbeitszufriedenheit von Allgemeinmedizinern.

BACKGROUND AND PURPOSE: In Germany there is a lack of general practitioners (GP) that is forecasted to grow. Against this background a study of job satisfaction is of major interest. The purpose of this study was to analyse the job satisfaction of German GPs. METHODS: The study is based on data from an observational study in 676 primary care physicians in Germany between 2004 and 2007 taking part in the European Practice Assessment (EPA). The evaluation of job satisfaction was one part of EPA. Job satisfaction was measured with the 10-item Warr-Cook-Wall (WCW) scale. The possible answers ranged from 1 (extreme dissatisfaction) to 7 (extreme satisfaction). Furthermore the characteristics of GPs (gender, age, working hours) were analysed. RESULTS: Overall from the 676 primary care physicians 523 were GPs and took part in the survey. Job satisfaction was low by "income", "hours of work" and "mental working condition". A high degree of satisfaction was reported for "colleagues and fellow workers". Mainly working hours had a significant influence of job satisfaction followed by age and gender. CONCLUSION: Overall, the results show good values of satisfaction with job situation. However there is space for improvement within the field of payment and working condition. Against this background of the lack of GPs it is important to consider these aspects of job satisfaction for GPs.

[Evaluation of special GP-centered health care contracts in Germany by the participating GPs. present situation and future perspectives]. / Hausarztzentrierte Versorgung aus Sicht der teilnehmenden Arzte : Aktuelle Situation und Perspektiven.

BACKGROUND AND PURPOSE: In 2004, German statutory health care funds were given the possibility to offer their insured a special general practitioner-( GP-)centered health care contract (HZV), since 2007 they are obliged to do so. The aim of these contracts is to strengthen the role of the GP as a coordinator in the health care system. Until now, the evidence regarding the GPs' view on these contracts is poor. A written survey was conducted in Hesse in order to learn how the participating GPs evaluate the regional HZV. METHODS: In Apri 2008, a questionnaire was developed, tested and mailed to 2,815 GPs who were participating in the GP-centered health care contract at that time. All analyses where conducted with SPSS (version 15.0). RESULTS: A total of 686 questionnaires were returned (response rate 24.4%). Altogether, the GPs' feedback ranged from great approval to clear disapproval of the contract. However, 70.0% of the survey's participants evaluated the HZV in general to be positive, 60.1% felt it strengthens their role as a GP. Quality circles on good prescribing and GP-specific education, obligatory parts of the HZV, were evaluated to be especially positive (70.3% and 69.4%, respectively). Positive effects were also seen concerning coordination of care (53.3%) and cooperation with patients (36.3%). Improvements concerning cooperation with specialists and hospitals were reported less often (24.9% and 13.0%, respectively). Workload because of additional administration for the HZV was criticized. CONCLUSION: In future, special GP-centered health care contracts should focus on improvement of cooperation between GPs and other caregivers. Workload for additional administration should be reduced.

Quality circles to improve prescribing of primary care physicians. Three comparative studies.

PURPOSE: To determine the effectiveness of quality circles on prescribing patterns of primary care physicians in Germany and to explore the influence of specific factors on changes. METHODS: Three large non-randomised comparative studies were performed in primary care in Germany, with baseline measurements in 2001 and follow-up measurements in 2003. 1090 physicians were in intervention groups and 2090 physicians in control groups. For each physician, data on 444 patients and 1201 prescriptions were available, on average, at each measurement moment. Quality circles comprising of a series of small group moderated meetings of physicians, provision of evidence-based information and repeated written feedback on individual prescribing patterns. RESULTS: Compared to the control groups, physicians in the intervention groups reduced mean prescription cost per patient per 3-month period by 1.87 euro (95%CI 0.51 to 3.22), increased generic drugs of all potentially generic prescriptions by 0.75% (95%CI 0.40 to 1.10), increased prescription of recommended lipid lowering drugs by 4.24% (95%CI 2.40 to 6.10), increased the prescription of recommended antibiotics by 1.72% (95%CI 0.33 to 3.10). Groups with more positive views of performance feedback, evidence-based indicators and price comparisons showed more change of prescribing. CONCLUSIONS: Quality circles had a modest effect on prescribing quality and costs. If widely implemented, they could have nationwide impact on the quality and costs of prescribing in primary care.

Testing a European set of indicators for the evaluation of the management of primary care practices.

BACKGROUND: Effective practice management is an important prerequisite for offering good clinical care. Internationally valid, reliable and feasible indicators and instruments are needed to describe and compare the management of primary care practices in Europe. OBJECTIVE: This paper describes development and evaluation of the European Practice Assessment instrument and indicators (Engels Y, Campbell S, Dautzenberg M et al. Developing a framework of, and quality indicators for, general practice management in Europe. Fam Pract 2005; 22(2): 215-22). METHODS: The study design was a validation and feasibility study set in 273 general practices in Austria, Belgium, France, Germany, Israel, The Netherlands, Slovenia, Switzerland and the UK. Use was made of a set of 62 valid quality indicators derived previously from an international Delphi procedure. The EPA instrument, based on this set of indicators, was used to collect data in the 273 practices. This instrument consists of self-completed questionnaires for doctors, staff managers and patients. In addition, there is an interview schedule for use by an outreach visitor, to be held with the lead GP or manager, and a visitor checklist. The instrument was analysed using expert review by the project partners, factor and reliability analyses, ANOVA analyses and by determining intraclass correlations. RESULTS: Fifty-seven indicators were found to be valid, feasible, reliable and discriminative in all participating countries. The instrument was able to determine differences in practice management within and between countries. All (but one) practices completed the assessment procedure. The data collection method appeared to be feasible, although some aspects can be improved. CONCLUSION: The EPA instrument provides feedback to practices that facilitates quality improvement and can compare primary care practices on a national and an international level.

Quality circles to improve prescribing patterns in primary medical care: what is their actual impact?

RATIONALE, AIMS AND OBJECTIVES: Quality circles comprise small group sessions of doctors and written feedback on their individual practice patterns. Although 50% of German primary care doctors participate in quality circles, their effectiveness has hardly been evaluated in Germany. This study determined the impact of a large-scale programme of quality circles on quality and costs of prescribing. METHOD: A controlled before-after study was performed, in which primary care doctors were allocated to a quality circles group or a control group. Subjects were 100,000 patients in 1996 and in 1998, who had visited one of 177 doctors in the 3 month registration periods in one region in Germany. The intervention comprised a quality circles programme, comprising 11 sessions and repeated feedback on prescribing. Main outcome measures were proportion of patients who received a prescription, mean prescription costs per patient and proportion of generic prescriptions. RESULTS: The absolute numbers of prescriptions decreased in both groups, but the mean prescription costs per patient increased. The quality circles reduced the proportion of patients who received a prescription (OR = 0.86) and the mean prescription costs per patient (B = -3.99 euro), while it increased the proportion of generic drugs (OR = 1.10). The intervention had intended effects on four of the 15 secondary indicators. CONCLUSIONS: Large-scale application of quality circles had intended effects on prescribing decisions in primary care in Germany. The effects found in this study may reflect better what improvements can be achieved than randomized trials of similar interventions.