[Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. / Methodischer Standard für die Entwicklung von Qualitätsindikatoren im Rahmen von S3-Leitlinien ­ Ergebnisse einer strukturierten Konsensfindung.

BACKGROUND: Recommendations of evidence- and formally consensus-based clinical practice guidelines (CPGs) represent a valuable source of quality indicators (QIs). Nevertheless, a standardized methodological procedure for developing QIs in the context of CPGs does not yet exist in Germany for all CPGs. For this reason, a methodological standard for the guideline-based development of QIs (QI Standard) was developed based on a structured consensus process involving multiple key stakeholders. METHODS: The proposed content of the QI Standard was derived from evidence, drawing upon results of reviews and qualitative studies, and considered German manuals for guideline-based QI development of two guideline programs. A multi-perspective consensus panel, broadly representing key stakeholders from the German healthcare system with expertise in CPGs and/or quality management, was nominated to vote on recommendations for guideline-based development of QIs. The iterative, structured consensus process included a two-stage online survey based on the Delphi method ("preliminary voting") and a moderated final stakeholder conference where all those recommendations were definitely included in the QI Standard that received approval of more than 75 % (consensus criterion) of the consensus panel. RESULTS: Based on the agreed QI Standard, the QI development process starts with a criteria-based selection of "potential" QIs which - in case of adoption - are published in CPGs as "preliminary" QIs and can achieve the status "final" after successful testing. The QI Standard is composed of a total of 30 recommendations, which are allocated to six areas: A) preparatory work steps for the guideline-based recommendation of QIs, B) QI development group and cooperation with the CPG group, C) development of potential QIs, D) critical appraisal of potential QIs, E) formal adoption and publication as well as F) piloting/testing of preliminary QIs and conversion into final QIs. DISCUSSION: Before the QI Standard can be recommended for implementation in future CPGs, it should have been successfully tested in selected German CPG projects. In addition to methodological requirements for the QI development, it must be ensured that guideline groups have adequate resources for the implementation of the QI Standard. CONCLUSION: By using the QI Standard, scientifically sound and healthcare-relevant QIs can be expected.

Quality indicators for a geriatric emergency care (GeriQ-ED) - an evidence-based delphi consensus approach to improve the care of geriatric patients in the emergency department.

INTRODUCTION: In emergency care, geriatric requirements and risks are often not taken sufficiently into account. In addition, there are neither evidence-based recommendations nor scientifically developed quality indicators (QI) for geriatric emergency care in German emergency departments. As part of the GeriQ-ED© research project, quality indicators for geriatric emergency medicine in Germany have been developed using the QUALIFY-instruments. METHODS: Using a triangulation methodology, a) clinical experience-based quality aspects were identified and verified, b) research-based quality statements were formulated and assessed for relevance, and c) preliminary quality indicators were operationalized and evaluated in order to recommend a feasible set of final quality indicators. RESULTS: Initially, 41 quality statements were identified and assessed as relevant. Sixty-seven QI (33 process, 29 structure and 5 outcome indicators) were extrapolated and operationalised. In order to facilitate implementation into daily practice, the following five quality statements were defined as the GeriQ-ED© TOP 5: screening for delirium, taking a full medications history including an assessment of the indications, education of geriatric knowledge and skills to emergency staff, screening for patients with geriatric needs, and identification of patients with risk of falls/ recurrent falls. DISCUSSION: QIs are regarded as gold standard to measure, benchmark and improve emergency care. GeriQ-ED© QI focused on clinical experience- and research-based recommendations and describe for the first time a standard for geriatric emergency care in Germany. GeriQ-ED© TOP 5 should be implemented as a minimum standard in geriatric emergency care.

[The Stepwise Care of Very Low Birth Weight Infants in Germany and Internationally]. / Die stufenweise Versorgung von sehr kleinen Frühgeborenen in Deutschland und international.

OBJECTIVE: In Germany the care of newborn infants is regulated by directives of the Federal Joint Committee. Assignment to the four levels of care, with level 1 being the highest level, is based on maternal risk factors, maternal and fetal diseases, birth weight and gestational age. This article compares birth weight and gestational age limits used in Germany with international regulations. METHODS: A manual search of websites of medical societies and regulative bodies in Europe, Northern America and Australia for regulations and guidelines was performed. RESULTS: Outside of Germany, level 1 is the lowest level of care. 2 to 7 levels are used. In Germany a birth weight<1250 g and a gestational age<29+0 weeks of gestation require treatment at the highest level. Internationally, the assignment to the highest level is most frequently defined by a birth weight of 1250 g or 1500 g. Birth weight is often associated with gestational age. The American Academy of Pediatrics refers to a meta-analysis in which the mortality was significantly lower if preterm infants with less than 1500 g and 32+0 weeks of gestation were born and treated in a highly specialized hospital. CONCLUSIONS: Birth weight and gestational age limits for the assignment of preterm infants to different levels of care are internationally inhomogeneous. Only one guideline provides a scientific justification for the assignment rules.

[Memorandum III, Part 3: Quality of Care and Patient Safety Research Methods]. / DNVF-Memorandum III "Methoden für die Versorgungsforschung", Teil 3: Methoden der Qualitäts- und Patientensicherheitsforschung.

The German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF)] fosters the methodological quality of health services research studies by memoranda and other initiatives. Quality of care and patient safety research (QCPSR) form core areas of health services research. The present memorandum explicates principal QCPSR questions and methods. Based on the issues' particular relevance for health policy, the memorandum exemplifies methods for developing and testing indicators, risk adjustment techniques, methods for collecting patient safety data, tools to analyse patient safety incidents and methods for evaluating often complex and multicomponent QCPS interventions. Furthermore, we point out urgent research topics.

German CABG score: a specific risk model for patients undergoing isolated coronary artery bypass grafting.

BACKGROUND: A specific risk model concerning mortality of patients undergoing isolated coronary artery bypass grafting (CABG) is developed based on the national quality benchmarking mandatory by law in Germany. METHODS: On the basis of the national data pool from 2004, a risk score model for patients undergoing isolated CABG was developed and finally adjusted with the data of 43,145 patients of the year 2008. Modeling was performed by logistic regression analysis. This risk model was validated with the 2007 data pool which comprised 45,569 patients. RESULTS: Observed in-hospital mortality after isolated CABG procedures was 3.0% in 2008. Hosmer-Lemeshow test p value was 0.189 and area under receiver operating characteristic curve was 0.826. Applying the German CABG score for 2007 resulted in an observed-to-expected mortality ratio of 1.01. CONCLUSION: The German CABG score for in-hospital mortality is a risk score with proven validity for isolated CABG, developed by means of the patient population in Germany. It can be used for the assessment of patient risk groups and for interhospital benchmarking. We encourage other researchers to apply and validate this score in comparable health care systems.

German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults.

OBJECTIVES: The aim of the study was to establish a scoring system to predict mortality in aortic valve procedures in adults [German Aortic Valve Score (German AV Score)] based upon the comprehensive data pool mandatory by law in Germany. METHODS: In 2008, 11 794 cases were documented who had either open aortic valve surgery or transcatheter aortic valve implantation (TAVI). In-hospital mortality was chosen as a binary outcome measure. Potential risk factors were identified on the basis of published scoring systems and clinical knowledge. First, each of these risk factors was tested in an univariate manner by Fisher's exact test for significant influence on mortality. Then, a multiple logistic regression model with backward and forward selection was used. Calibration was ascertained by the Hosmer-Lemeshow method. In order to define the quality of discrimination, the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS: In 11 147 of 11 794 cases (94.5%), a complete data set was available. In-hospital mortality was 3.7% for all patients, 3.4% in the surgical group (95% confidence interval 3.0-3.7%, n = 10 574) and 10.6% in the TAVI group (95% confidence interval 8.2-13.5%, n = 573). Based on multiple logistic regression, 15 risk factors with an influence on mortality were identified. Among them, age, body mass index and left ventricular function were categorized in three (body mass index, left ventricular dysfunction) or 6 subgroups (age). The Hosmer-Lemeshow method corroborated a valid concordance of predicted and observed mortality in 10 different risk groups. The area under the ROC curve with a value of 0.808 affirmed the quality of discrimination of the established scoring model. CONCLUSIONS: It is well known that a predictive model works best in the setting where it was developed; therefore, the German AV Score fits well to the patient population in Germany. It was designed for fair and reliable outcome evaluation. It allows comparison of predicted and observed mortality for conventional aortic valve surgery and transcatheter aortic valve implantation in low-, moderate- and high-risk groups. Thus, it enables primarily a risk-adjusted benchmark of outcome and fosters the efforts for continuous improvement of quality in aortic valve procedures.

Selection of hospital quality indicators for public disclosure in Germany.

OBJECTIVES: This paper introduces the QUALIFY instrument as an indicator assessment method used to select quality indicators suitable for public disclosure in Germany. METHODS: Fifty-five hospital quality indicators previously approved in routine use were systematically tested for suitability in public disclosure. A multi-disciplinary expert team including patient representatives used the QUALIFY instrument to assess the methodological quality of these indicators in detailed respect to their purpose. The team applied 14 of the 20 QUALIFY criteria to each indicator, the minimum acceptance level for public reporting was determined in advance. RESULTS: Thirty one indicators from eleven clinical conditions fulfilled all fourteen methodological criteria required for national reporting. They include eleven outcome and twenty process indicators. CONCLUSIONS: QUALIFY proved to be a useful tool for selecting quality indicators suitable for public disclosure and thus contributes substantially to proper information on German hospital quality. It ensures high transparency in a very sensitive context to all stakeholders.

[Certification of myasthenia centres: developing and implementing a certification procedure for patient organisations]. / Zertifizierung von Myasthenie-Zentren - Entwicklung und Umsetzung eines Zertifizierungsverfahrens für Patientenorganisationen.

BACKGROUND: Certifications for quality management systems or disease-specific certifications have become increasingly popular in the German healthcare system. For chronic or rare diseases, however, patient safety and a patient-centred healthcare management have high priority. These aspects are often not adequately accounted for by the usual certification models. METHODS: The BQS Institute for Quality and Patient Safety has developed a certification for the Deutsche Myasthenie Gesellschaft (DMG), a patients' self-help organisation. Standards for the certification were drafted by medical experts on the basis of guidelines and the scientific literature and were implemented into applicable criteria by the BQS Institute. Special emphasis was placed on translating patients' needs into the criteria catalogue. RESULTS: The certificate "Integrierte Myasthenie-Zentren der DMG" [Integrated Myasthenia Centres of the DMG] is based on an all-day audit and includes a peer review. The active involvement of patients in the audit teams and in the certification board ensures that patient-relevant aspects are consistently taken into consideration besides medical criteria and quality management requirements. Notwithstanding the high medical quality in the two hospitals participating in the pilot phase, additional potential for improvement could be identified during the audits. DISCUSSION: Certifications issued under the responsibility of patient organisations meet the need for specific quality improvement instruments for chronic and rare diseases. Acceptance of those certifications is enhanced by peer reviewing during the audits. From the patients' viewpoint all important aspects were incorporated into the certification concept.

[BQS1 indicators as a monitoring tool for guideline implementation using selected quality indicators in the treatment of patients with breast cancer and femoral neck fractures]. / Qualitätsindikatoren der BQS als Monitoring--Instrument zur Leitlinienimplementierung am Beispiel ausgewählter Qualitätsindikatoren bei Mammakarzinom und Schenkelhalsfraktur.

Successfully implemented clinical guidelines can contribute to improvement in the quality of care. In the context of clinical guidelines, quality indicators play an important role. Quality indicators can contribute to the further development and updating of existing guidelines by analysing their results. In addition, these results support internal and external quality improvement activities and supply information on the implementation status of guideline recommendations giving an impression of the actual quality of care. In this paper the data of the mandatory German performance measurement (specimen radiograph of impalpable breast lesions, preoperative waiting time with femoral neck fracture) were analysed in respect to the extent that guideline recommendations have been implemented in clinical care. We analysed a database of 189,756 and 331,087 patients for the quality indicators 'specimen radiograph' and 'preoperative waiting time', respectively. Depending on the quality of the clinical guideline the results varied. After the publication of this recommendation as part of the German high-quality guideline for neoplasms of the breast in 2004 the proportion of radiographic controls of specimens after breast cancer surgery increased from initially 36% to 84% in 2006, and the variance as a measure of the variability of care decreased considerably. By contrast, the percentage of patients with femoral neck fracture undergoing surgery within 48h did not change noticeably (2003: 19%; 2006: 16%). A German high-quality guideline making a clear recommendation for early surgery does not yet exist. Quality indicators of the German mandatory performance measurement system are suitable for measuring the extent to which guideline recommendations have been implemented and for supporting their (further) development.

[QUALIFY--a tool for assessing quality indicators]. / QUALIFY: Ein Instrument zur Bewertung von Qualitätsindikatoren.

Quality indicators are used world-wide to control the quality of health care. To be effective these indicators have to meet quality criteria themselves. But until now there has been no fully operational method for assessing indicators. Using a systematic review of existing criteria and scientific analyses the criteria set QUALIFY was developed. Particular characteristics of QUALIFY include clear definitions of all criteria, consistent information as the basis of assessment and a standardized approach throughout the assessment process. QUALIFY comprises 20 criteria which are assigned to the three categories relevance, scientific soundness and feasibility. It was tested during the assessment of 55 indicators and served as the methodological basis for selecting those quality indicators that German hospitals are required to report publicly.