[Relationship between volume and structural characteristics and the quality of outcomes of perinatal centers for infants at the border of viability]. / Zusammenhang zwischen der Fallzahl und Strukturmerkmalen und der Ergebnisqualität von Perinatalzentren Level 1 für Frühgeborene an der Grenze der Lebensfähigkeit.

INTRODUCTION: This study investigates the relationship between volume, structural characteristics and quality of outcome, specifically for infants at the border of viability. METHODS: Using administrative data of the largest provider of statutory healthcare insurance in Germany between 2010-2015, infants with an admission weight (AW) between 250-1249 g treated initially in perinatal centers were included. For infants at the border of viability (250-499 g AW), the endpoints mortality and mortality or morbidity were analyzed. For comparison, infants with 500-749 g and 750-1249 g AW were analyzed. The impact of categorized volume (in quartiles) and structural characteristics (university hospital and in-house pediatric surgery) were examined in separate regressions. Odds ratios (ORs) and potentially avoidable deaths or severe morbidity were calculated. RESULTS: Infants with 250-499 g AW were significantly more likely to survive if initially treated in perinatal centers with an estimated volume of 62 cases (250-1249 g AW) per year (OR: 0.43; 95%-CI: 0.20-0.96) or in university perinatal centers with in-house pediatric surgery (OR: 0.48; 95%-CI: 0.24-0.93). There was also a positive impact of volume and structural characteristics for infants with 500-749 g and 750-1249 g AW. CONCLUSION: In addition to volume, structural characteristics also have a positive impact on the quality of outcomes. Additional requirements of structural characteristics for perinatal centers as well as a higher minimum volume may have a relevant positive impact on the outcome.

The Outcome of Laparoscopic Versus Open Appendectomy in Childhood.

BACKGROUND: Appendectomy in children is performed either lapa - roscopically (LA) or by open surgery (OA). We studied whether, and how, the outcome is affected by the technique used and by the intraoperative conversion of LA to OA. METHODS: We analyzed routine data from children and adolescents in three age groups (1-5 years, 6-12 years, and 13-17 years) who were insured by the AOK statutory health insurance carrier in Germany and who underwent appendectomy in the period 2017-2019. General surgical complications and reoperations within 90 days were assessed with relevant indicators. Associations between the surgical technique and these indicators were studied with logistic regression. RESULTS: Of the 21 541 patients included in the study, general surgical complications were observed in 2.1% and reoperations in 1.8% overall. Broken down by age group, the corresponding figures were 5.4% and 4.4% (age 1 to 5), 2.5% and 1.8% (age 6 to 12), and 1.5% and 1.6% (age 13 to 17). The main risk factors for complications and reoperations were acute complicated appendicitis and conversion from LA to OA. Regression analysis revealed similar outcomes with OA compared to LA in the 1-to-5 age group, (odds ratios and 95% confidence intervals: 1.1 [0.6; 2.1] for general surgical complications and 1.5 [0.8; 2.7] for reoperations), but worse outcomes with OA in the other two age groups (age 6 to 12: 1.9 [1.2; 2.9] and 2.1 [1.5; 2.9]; age 13 to 17: 1.7 [1.0; 2.9] and 2.2 [1.4; 3.6]). When conversions were assigned to the LA group, the odds ratio (OA compared to LA) for reoperation across all age groups was 3.5 [2.8; 4.4] in patients with acute uncomplicated appendicitis and 4.2 [3.4; 5.3] in patients with complicated appendicitis. Complicated appendicitis also increased the rate of general surgical complications and the length of stay in hospital. CONCLUSION: Among children in the two older age groups, LA was followed by fewer general surgical complications and reoperations than OA. These differences were less pronounced when conversions were counted as belonging to the LA group. Children aged 1-5 appear to benefit the least from the lapa - roscopic technique.

Population-Based Outcome Data of Extremely Preterm Infants in Germany during 2010-2017.

BACKGROUND AND OBJECTIVE: Results of five randomized controlled trials (RCT) sequentially published in 2010-2013 suggested that aiming for higher, as opposed to lower oxygen saturation targets, reduces rates of mortality in infants <28 weeks of gestation, while increasing rates of severe retinopathy of prematurity (ROP). Two further RCTs published in 2011 and 2015 demonstrated that avoiding endotracheal intubation by minimally invasive surfactant administration reduces respiratory morbidity. Assuming that such data are likely to affect clinical practice and ultimate outcome, we analyzed population-level results in extremely preterm infants born across Germany during 2010-2017. METHODS: We used mandatory German quality surveillance data to compare mortality and morbidities in preterm infants born between 24 weeks 0 days and 27 weeks 6 days of gestation in 2010-2013 versus 2014-2017. RESULTS: Mortality decreased from 15.1% (1,366/9,058) in 2010-2013 to 12.7% (1,385/10,924) in 2014-2017, risk ratio (RR) 0.845 (95% confidence interval [CI], 0.784-0.901). Rates of severe ROP (≥grade 3) per survivor increased from 12.1% (930/7,692) to 13.3% (1.269/9,539), RR 1.100 (95% CI: 1.017-1.191). The lowest mortality and highest ROP rates were found in infants born in 2014. There was no change in rates of necrotizing enterocolitis, while those of bronchopulmonary dysplasia (BPD) decreased steadily between 2010 and 2017, alongside the increased proportion of infants who were never intubated. CONCLUSIONS: There was a moderate decline in mortality, an insignificant increase in severe ROP, and a steady decline of BPD in Germany during 2010-2017. Avoiding endotracheal intubation may have contributed to lowered BPD rates.

Rates of Complications After Appendectomy in Children and Adolescents: Pediatric Surgical Compared to General Surgical Hospitals.

BACKGROUND: Appendectomies in children and adolescents are performed in Germany in pediatric surgical (PS) or general surgical hospitals (GS). The aim of this study is to evaluate whether the surgery in a PS or GS hospital has an influence on the postoperative course after appendectomy in children and adolescents. MATERIALS AND METHODS: Nationwide routine data from children and adolescents aged 1-17 y insured by the Local Health Insurance Fund who underwent appendectomy between 2014 and 2016 were analyzed (cohort study). Descriptive statistics were calculated both overall and in the two groups (PS and GS). Patients were additionally examined by age (1-5, 6-12, and 13-17 y), treatment (laparoscopic, open surgical, and conversion), and appendicitis type (nonacute: K36/K37/K38/R10, acute simple: K35.30/K35.8, and acute complex: K35.2/K35.31/K35.32). The influence of surgeon specialization on 90-d secondary surgery and 90-d general complications was assessed by multiple logistic regression. RESULTS: Altogether, 25,065 patients who underwent surgery in 83 PS and 906 GS hospitals were included. Logistic regression analysis revealed that PS was associated with a reduced risk of interventions in the 1-5- and 6-12-y age groups (odds ratio: 0.44, 0.62). Acute complex appendicitis, comorbidities, and open surgery significantly increased the risk for reintervention. PS was associated with an increased risk for complications in the 13-17-y age group (odds ratio: 1.66). CONCLUSIONS: PS and GS hospitals provided safe appendectomies in children and adolescents with low reintervention and complication rates. PS hospitals demonstrated advantages for patients in the 1-5- and 6-12-y age groups and GS hospitals for patients 13-17 y.

[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.

The German Aortic Valve Score II.

OBJECTIVES: The German Aortic Valve Score (GAVS) was developed for national quality assurance regarding the in-hospital mortality rate of patients following isolated aortic valve replacement. The goal of this work was the recalibration of the GAVS in the context of increased numbers of transcatheter aortic valve implantations. METHODS: In 2011 and 2012, 36 183 cases were documented who had either surgical aortic valve replacement or transcatheter aortic valve implantation (45%). All cases were randomly assigned to the study or to the validation group. All items of the data set were checked for significance by developing a multiregression risk model using iterative backward elimination. Calibration was ascertained using the Hosmer-Lemeshow method. To define the quality of discrimination, the area under the receiver operating characteristic curve (C-statistic) was calculated. RESULTS: The randomized study cohort comprised 18 054 patients. After modelling with multiple regression algorithms, 18 of the initial 28 risk factors entered the risk model. When applied to the validation group, the newly developed GAVS II showed good calibration with a P-value of 0.411 in the Hosmer-Lemeshow test and good discrimination with a C-statistic of 0.741. CONCLUSIONS: The GAVS II is a new risk model that is applicable to cohorts having surgical aortic valve replacement or transcatheter aortic valve implantation procedures.

Case Numbers and Process Quality in Breast Surgery in Germany: A Retrospective Analysis of Over 150,000 Patients From 2013 to 2014.

BACKGROUND: Numerous studies from around the world have shown a positive association between case numbers and the quality of medical care. The evidence to date suggests that conformity to guidelines for the treatment of patients with breast cancer is better in German hospitals that have higher case numbers. METHODS: We used data obtained by an external program for quality assurance in inpatient care (externe stationäre Qualitätssicherung, esQS) for the years 2013 and 2014 to investigate seven process indicators in the area of breast surgery, including histologic confirmation of the diagnosis before definitive treatment, axillary dissection as recommended by the guidelines, and an appropriate temporal interval between diagnosis and operation. Case numbers were categorized with the aid of various threshold values. Moreover, subgroup analyses were carried out for patients under age 65, patients in good general health, patients without lymph-node involvement, and patients with a tumor size pT0 or pT1 or an overall tumor size less than 5 cm. RESULTS: Data on 153,475 patients from 939 hospitals were analyzed. Six of seven indicators had values that were better overall, to a statistically significant extent, in hospitals with higher case numbers. Although this relationship was not consistently seen, the worst results were generally found in the category with the lowest case numbers. Similar though less striking results were obtained in the subgroup analyses. An exception to the general finding was that, in hospitals with higher case numbers, the interval between diagnosis and operation was more often longer than three weeks. CONCLUSION: Guideline adherence is higher in hospitals that treat more cases. The present study does not address the question whether this, in turn, affects morbidity or mortality. To improve process quality in peripheral hospitals, the quality assurance program should be continued.

[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.

[Hospitalisations for ambulatory care sensitive conditions in Germany]. / Krankenhausfälle für ambulant behandelbare Erkrankungen in Deutschland.

BACKGROUND: On the basis of the assumption that a significant proportion of hospitalisations for so-called ambulatory care sensitive conditions (ACSCs) are potentially avoidable by ambulatory care measures, hospitalisation rates for ACSCs are used internationally as population based indicators for access to and quality of ambulatory care. The German Council of Health Experts proposes hospitalisation rates for diabetes, asthma, hypertension and chronic heart failure as ACSC measures in Germany. OBJECTIVES: This article focuses on regional differences in ACSC rates, describes the longitudinal development and explores potential determinants. MATERIAL AND METHODS: Descriptive statistical analyses as well as spatial regression analyses were performed on the basis of Federal Statistical Office data. We included data from the hospital and physician statistics. Bayesian spatial regression techniques were used. RESULTS: Whereas hospitalisation rates for asthma decreased between 2000 and 2010, hospitalisation rates for diabetes, hypertension and chronic heart failure increased. Comparing age-adjusted ACSC rates across all German federal states, the Eastern states as well as Saarland showed significantly higher ACSC rates over time. This observation can in part be explained by physician density and the number of hospital beds. CONCLUSION: Although not all ACSC hospitalisations can be avoided, these results display a potential for optimising care across healthcare sectors in Germany.

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.

Factors associated with differences in antihypertensive drug treatment: results from the MONICA Augsburg Population Surveys 1989/90 and 1994/95.

OBJECTIVE: To investigate in a population-based sample of hypertensive men and women the impact of factors that determine frequency and pattern of antihypertensive treatment. METHODS: We used pooled data of two independent surveys conducted 1989/90 and 1994/95 in the Augsburg region among men and women aged 25 to 74 years. Co-morbidity and cardiovascular risk factors were assessed by questionnaire and examination. Multivariate and polytomous logistic regression analyses were used to assess treatment patterns adjusting for cofactors. RESULTS: Among a total of 9,795 survey participants, 2,279 men and 1,699 women were hypertensive with 30% of men and 43% of women using antihypertensive drugs. Hypercholesterolemia was unrelated and smoking even inversely related to treatment (adjusted odds ratio OR = 0.7, 95% CI 0.56-0.92). Women were more likely to be treated than men (adjusted OR = 1.6, 95% CI: 1.34-1.82). Furthermore, women on monotherapy used diuretics significantly more often than men (adjusted OR relative to betablocker use 2.8, 95% CI: 1.6-4.8). CONCLUSIONS: We identified several determinants of drug treatment among hypertensives in the community. During the study period antihypertensive treatment seemed to be determined primarily by clinical disease but not by concomitant cardiovascular risk factor status, such as male gender, smoking, or hypercholesterolemia.

[The predictive value of a classification for proliferative diabetic vitreoretinopathy]. / Klinische Bedeutung einer Stadieneinteilung der proliferativen diabetischen Vitreoretinopathie.

BACKGROUND: Kroll's classification of proliferative diabetic vitreoretinopathy (PDVR) defines stage A (vitreoretinal proliferations without retinal detachment), stage B (partially detached retina not involving the macula), stage C (partially detached macula) and stage D (completely detached macula). The purpose of this study was to analyse the prognostic value of Kroll's classification in respect of the postoperative results of vitreoretinal surgery based on our group of patients. PATIENTS AND METHODS: The charts of 563 patients who underwent vitrectomy because of PDVR between 1990 and 1997 were examined retrospectively. Postoperative visual acuity, possible risk factors, frequencies of silicone oil tamponade and revitrectomies were related to the preoperative staging of PDVR. The influence of possible predictive factors on the postoperative visual outcome were evaluated using multivariate logistic regression analysis. RESULTS: After vitreoretinal surgery mean postoperative visual acuity was significantly better in stage A compared to stage C (p < 0.01) or D (p < 0.0001). In 179 out of 563 eyes (31.7 %) revitrectomy (including silicone oil removal) was required and in 51 eyes (9.1 %) more than one revitrectomy was performed. Silicone oil tamponade was used in 22 out of 253 eyes (8.7 %) classified as stage A, in 27 out of 201 eyes (13.4 %) of stage B, in 17 out of 78 eyes (21.8 %) of stage C and in 10 of 31 eyes (32.3 %) of stage D. Postoperative increase of visual acuity of more than 3 lines was significantly less frequent in stage B (p < 0.014), C (p < 0.039) and D (p < 0.001) compared to stage A. CONCLUSION: Kroll's classification for PDVR has a high prognostic value for the postoperative visual outcome and level of surgical risk management. Thus patients with good prognosis can be identified easily, facilitating the decision for surgery.