[Recommendations for the specialist further training of nursing personnel on intensive care units in the treatment of abdominal aortic aneurysms: results of a modified Delphi procedure with experts]. / Empfehlungen zur Fachweiterbildung von Pflegefachpersonen der Intensivstation bei der Behandlung des Bauchaortenaneurysmas: Ergebnisse eines modifizierten Delphi-Verfahrens mit Expert:innen.

INTRODUCTION: The medical development in the previous 15 years and the changes in treatment reality of the comprehensive elective treatment of abdominal aortic aneurysms necessitate a re-evaluation of the quality assurance guidelines of the Federal Joint Committee in Germany (QBAA-RL). In the current version this requires a specialist further training quota for nursing personnel in intensive care wards of 50%. The quota was determined in 2008 based on expert opinions, although a direct empirical evidence base for this does not exist. METHODS: Representatives from the fields of patient representation, physicians, nursing personnel and other relevant interface areas were invited to participate in a modified Delphi procedure. Following a comprehensive narrative literature search, a survey and focus group discussions with national and international experts, a total of three anonymized online-based voting rounds were carried out for which previously determined key statements were assessed with a 4­point Likert scale (totally disagree up to totally agree). In addition, the expert panel had also defined a recommendation for a minimum quota for the specialist training of nursing personnel on intensive care wards in the treatment of abdominal aortic aneurysms, whereby an a priori agreement of 80% of the participants was defined as the consensus limit. RESULTS: Overall, 37 experts participated in the discussions and three successive voting rounds (participation rate 89%). The panel confirmed the necessity of a re-evaluation of the guideline recommendations and recommended the introduction of a shift-related minimum quota of 30% of the full-time equivalent of nursing personnel on intensive care wards and the introduction of structured promotional programs for long-term elevation of the quota. CONCLUSION: In this national Delphi procedure with medical and nursing experts as well as representatives of patients, the fundamental benefits and needs of professional specialist qualifications in the field of intensive care medicine were confirmed. The corresponding minimum quota for specialist further training of intensive care nursing personnel should generally apply without limitations to specific groups. The expert panel stipulates a shift-related minimum quota for intensive care nursing personnel with specialist training of 30% of the nursing personnel on intensive care wards and the obligatory introduction of structured and transparent promotion programs for the long-term enhancement.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

[Routine Practice Data for Evaluating Intervention Effects: Part 2 of the Manual]. / Versorgungsnahe Daten zur Evaluation von Interventionseffekten: Teil 2 des Manuals.

The evaluation of intervention effects is an important domain of health services research. The ad hoc commission for the use of routine practice data of the German Network for Health Services Research (DNVF) therefore provides this second part of its manual focusing on the use of routine practice data for the evaluation of intervention effects. First, we discuss definition issues and the importance of contextual factors. Subsequently, general requirements for planning, data collection and analysis as well as concrete examples for the evaluation of intervention effects for the 3 fields of application regarding pharmacotherapy, nonpharmaceutical interventions as well as complex interventions are elaborated. We consider scenarios in which no information from randomized controlled trials (RCTs) comparing the two groups directly is yet available or in which RCTs are already available but an extension of the research question is required. In all examples either with or without randomization, the first and foremost question is always whether the data source is suitable for the specific research question. Most of the examples chosen are from oncology trials, because the necessary data are already available for Germany, at least in some form. Finally, the manual discusses possible challenges for future use of these data.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

[Are men and women with breast cancer treated equally in Germany?] / Werden Männer und Frauen mit Brustkrebs in Deutschland gleichbehandelt?

INTRODUCTION: Within the statutory health insurance system of the Federal Republic of Germany, a system of quality assurance has been implemented and operationalised through the measurement of quality indicators. For breast surgery, these quality indicators are mainly based on recommendations of the German clinical guideline for screening, diagnosis, therapy and follow-up of breast cancer. The 2018 update of this guideline includes a new chapter on breast cancer in men. The aim of this analysis is to examine whether male and female patients with breast cancer are treated equally where appropriate and recommended by the clinical guideline, as measured by the quality indicators. METHOD: Data of ten quality assurance indicators were analysed, for each indicator separately, stratified by sex and pooled over a 5-year period to gain statistical power. This dataset constitutes the largest data pool of men with surgical interventions for breast neoplasm in Germany. Indicator results were then compared between male and female cases. Additional subgroup analyses were carried out for two quality indicators with substantial outcome difference between male and female cases in order to detect possible differences in the treatment of breast cancer between different medical departments. RESULTS: The database of the ten quality assurance indicators comprised 551,221 patients (546,324 females and 4,897 males) between 2014 and 2018. Pooled data of nine quality indicators (QIs) showed statistically significant outcome differences between male and female cases. In spite of pooling, the male sample size of four QIs was too small to allow for statistically reliable comparisons between male and female patients. Outcome differences in the remaining five QIs may, on the one hand, be explained by anatomical differences and different extent of the surgery, and on the other hand they confirm international data for lower HER2-positivity rates in male breast cancer patients. However, two process indicators, aiming at pretherapeutic biopsy and sentinel lymph node biopsy in invasive breast cancer recommended by the clinical guideline, show substantial differences of more than 6 percentage points between the sexes: although recommended by the clinical guideline, both procedures are carried out less often in male cases. Further analysis regarding the medical departments that recorded the treatment revealed that risk for non-adherence to guideline recommendation was high if treatment took place in non-gynaecological departments. Compared to gynaecological departments, procedures such as pretherapeutic biopsy and sentinel lymph node biopsy were carried out less frequently if cases were documented to be handled by surgery or plastic surgery departments. DISCUSSION AND CONCLUSION: Analysis of breast surgery quality indicators reveals a lower level of adherence to guideline recommendations for men with breast cancer compared to women in some aspects of the guideline, as measured by statutory quality indicators in breast surgery. Male breast cancer might be a rare disease, but nevertheless, awareness-rising is needed in diagnostics, treatment and interdisciplinarity in order to avoid inequality between the sexes.

Decision-to-Delivery Time and Perinatal Complications in Emergency Cesarean Section.

BACKGROUND: A decision-to-delivery interval (DDI) of no more than 20 minutes has long been considered a requirement for cesarean sections, even though there have hardly been any studies on this topic. We retrospectively investigated data relevant to DDI for emergency cesarean sections performed for the most common indications, namely, suspected and documented fetal asphyxia. METHODS: We analyzed data on emergency in-hospital cesarean sections in the period 2008-2015. Low 5- and 10-minute Apgar scores (a scheme with points awarded for breathing, heart rate, muscle tone, skin coloration, and the elicitability of reflexes) were the primary endpoints; acid-base status in arterial cord blood and in-hospital neonatal death were the secondary endpoints. The raw analysis was supplemented by an analysis adjusted for various factors including gestational age, maternal age, and obstetrical presentation. RESULTS: Data from 39 291 neonates were included. The DDI was up to 10 minutes in 64.6% of cases, from 11 to 20 minutes in 34.3%, and over 20 minutes in 1.1%. Low Apgar scores were less common in children whose emergency cesarean sections were performed within 10 minutes or within 20 minutes. For example, the adjusted odds ratio for a 10-minute Apgar score below 4 was 0.49 (95% confidence interval [0.25; 0.96] when a DDI of more than 20 minutes was used as the reference criterion. CONCLUSION: This is the largest population-based, risk-adjusted analysis to be carried out on this topic to date. It reveals, for the first time, an association between DDI of 20 minutes or less and the avoidance of outcomes that are dangerous to the child. As it is not possible to predict such obstetrical emergencies in advance, it seems reasonable to ensure the availability of caredelivery structures that make it possible for emergency cesarean sections to be performed within 20 minutes of the decision to do so.

TAVI for low-flow, low-gradient severe aortic stenosis with preserved or reduced ejection fraction: a subgroup analysis from the German Aortic Valve Registry (GARY).

AIMS: The study analyses the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) for different subtypes of severe aortic stenosis (AS) based on data from the GARY registry. METHODS AND RESULTS: Low-EF, low-gradient (LEF-LGAS: EF ≤40%, MPG <40 mmHg), paradoxical low-gradient (PLF-LGAS: EF ≥50%, MPG <40 mmHg) and high-gradient AS (HGAS: MPG ≥40 mmHg) were observed in 11.7% (n=359), 20.8% (n=640) and 60.6% (n=1,864) of the study population, respectively. EuroSCORE I (36.7±20.9 vs. 22.6±15.7 vs. 24.3±17.4; p<0.001) differed significantly among subgroups. In-hospital and one-year mortality were higher in patients with LEF-LGAS compared to HGAS (in-hospital: 7.8% vs. 4.9%; p=0.029; one-year: 32.3% vs. 19.8%; p=0.001). In contrast, mortality in patients with PLF-LGAS was comparable to patients with HGAS (in-hospital: PLF-LGAS: 5.3%; p=0.67; one-year: 22.3%; p=0.192). The rate of TAVI-associated complications was not significantly different among groups. However, postoperative low cardiac output occurred significantly more frequently in patients with LEF-LGAS Conclusions: Severe AS with a reduced transaortic flow and gradient is a common finding and is present in >30% of patients undergoing TAVI. Patients with low flow and impaired LV function have a significantly higher mortality within the first year after TAVI. In contrast, the outcome of patients with low flow and preserved EF is comparable to those with a high transvalvular aortic gradient.

The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease.

OBJECTIVES: The German Aortic Valve Registry (GARY) seeks to provide information on a real-world, all-comers basis for patients undergoing aortic valve interventions. This registry comprises patients undergoing the complete spectrum of transcutaneous and conventional surgical aortic valve interventions. The aim of this study was to use the GARY registry to evaluate conventional and catheter-based aortic valve interventions in several risk groups. METHODS: A total of 13 860 consecutive patients undergoing intervention for aortic valve disease [conventional aortic valve replacement (AVR) or transvascular/transapical TAVR (TV-/TA-TAVR)] were enrolled in 78 German centres in 2011. Baseline, procedural and outcome data, including quality of life, were acquired up to 1 year post-intervention. Vital status at 1 year was known for 98.1% of patients. RESULTS: The 1-year mortality rate was 6.7% for conventional AVR patients (n = 6523) and 11.0% for patients who underwent AVR with coronary artery bypass grafting (n = 3464). The 1-year mortality rate was 20.7 and 28.0% in TV- and TA-TAVR patients, respectively (n = 2695 and 1181). However, if patients were stratified into four risk groups by means of the EuroSCORE and the German AV Score, the highest risk cohorts showed the same mortality at 1 year with either therapy. More than 80% of patients in all groups were in the same or better state of health at 1 year post-intervention and were satisfied with the procedural outcome. CONCLUSIONS: Conventional AVR surgery yields excellent results after 1 year in lower-risk patients. Catheter-based AVR is a good alternative in high-risk and elderly patients.

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.

The German Aortic Valve Registry (GARY): in-hospital outcome.

BACKGROUND: Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. METHODS AND RESULTS: A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). CONCLUSION: The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

[Potentials of cooperative quality management initiatives: BQS Institute projects, January 2010 - July 2013]. / Bericht aus der Praxis: Möglichkeiten einrichtungsübergreifender Qualitätsinitiativen. QS-Projekte des BQS-Instituts Januar 2010 bis Juli 2013.

Alongside the projects of internal quality management and mandatory quality assurance there is a variety of quality driven projects across institutions initiated and run by various partners to continuously improve the quality of care. The multiplicity and characteristics of these projects are discussed on the basis of projects run by the BQS Institute between 2010 and 2013. In addition, useful interactions and linking with mandatory quality benchmarking and with internal quality management are discussed. (As supplied by publisher).

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.

The care of preterm infants with birth weight below 1250 g: risk-adjusted quality benchmarking as part of validating a caseload-based management system.

BACKGROUND: In Germany, controversy currently surrounds the contention that the quality of care for preterm infants weighing less than 1250 g is best assured by requiring that centers treat a minimum of 30 such cases per year. METHODS: A risk-adjusted model was developed on the basis of neonatal data from 7405 preterm infants treated in German centers, and the effect of caseload on risk-adjusted mortality was analyzed. In addition, the discriminative ability of the minimal caseload requirement for quality assessment was studied. The authors designate the quality of care in a particular center as above average if the observed mortality is lower than would have been expected from the risk profile of the preterm infants treated there. RESULTS: Risk-adjusted mortality was found to be significantly higher in smaller centers (those with fewer than 30 cases per year) than in larger ones (odds ratio, 1.34). Even among centers whose caseload exceeded the minimum requirement, there was still marked variability in risk-adjusted mortality (range: 3.5% to 28.6%). Of all the preterm infants treated in larger centers, 56% were treated in centers with above-average quality of care. 44% of the centers with above-average quality of care had caseloads in the range of 14 to 29 cases per year. CONCLUSION: Because of the marked variability in risk-adjusted mortality, even among larger centers, a caseload of 30 or more cases per year is not a suitable indicator of the quality of care. The neonatal data of external quality assurance should be used to develop an instrument for quality-based coordination of care that takes not just morbidity and mortality, but also the treating centers' competence profiles into account.

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.