Socioeconomic disparities in changes to preterm birth and stillbirth rates during the first year of the COVID-19 pandemic: a study of 21 European countries.

BACKGROUND: Despite concerns about worsening pregnancy outcomes resulting from healthcare restrictions, economic difficulties and increased stress during the COVID-19 pandemic, preterm birth (PTB) rates declined in some countries in 2020, while stillbirth rates appeared stable. Like other shocks, the pandemic may have exacerbated existing socioeconomic disparities in pregnancy, but this remains to be established. Our objective was to investigate changes in PTB and stillbirth by socioeconomic status (SES) in European countries. METHODS: The Euro-Peristat network implemented this study within the Population Health Information Research Infrastructure (PHIRI) project. A common data model was developed to collect aggregated tables from routine birth data for 2015-2020. SES was based on mother's educational level or area-level deprivation/maternal occupation if education was unavailable and harmonized into low, medium and high SES. Country-specific relative risks (RRs) of PTB and stillbirth for March to December 2020, adjusted for linear trends from 2015 to 2019, by SES group were pooled using random effects meta-analysis. RESULTS: Twenty-one countries provided data on perinatal outcomes by SES. PTB declined by an average 4% in 2020 {pooled RR: 0.96 [95% confidence intervals (CIs): 0.94-0.97]} with similar estimates across all SES groups. Stillbirths rose by 5% [RR: 1.05 (95% CI: 0.99-1.10)], with increases of between 3 and 6% across the three SES groups, with overlapping confidence limits. CONCLUSIONS: PTB decreases were similar regardless of SES group, while stillbirth rates rose without marked differences between groups.

Trends in caesarean section rates in Europe from 2015 to 2019 using Robson's Ten Group Classification System: A Euro-Peristat study.

OBJECTIVE: To assess changes in caesarean section (CS) rates in Europe from 2015 to 2019 and utilise the Robson Ten Group Classification System (TGCS) to evaluate the contribution of different obstetric populations to overall CS rates and trends. DESIGN: Observational study utilising routine birth registry data. SETTING: A total of 28 European countries. POPULATION: Births at ≥22 weeks of gestation in 2015 and 2019. METHODS: Using a federated model, individual-level data from routine sources in each country were formatted to a common data model and transformed into anonymised, aggregated data. MAIN OUTCOME MEASURES: By country: overall CS rate. For TGCS groups (by country): CS rate, relative size, relative and absolute contribution to overall CS rate. RESULTS: Among the 28 European countries, both the CS rates (2015, 16.0%-55.9%; 2019, 16.0%-52.2%) and the trends varied (from -3.7% to +4.7%, with decreased rates in nine countries, maintained rates in seven countries (≤ ± 0.2) and with increasing rates in 12 countries). Using the TGCS (for 17 countries), in most countries labour induction increased (groups 2a and 4a), whereas multiple pregnancies (group 8) decreased. In countries with decreasing overall CS rates, CS tended to decrease across all TGCS groups, whereas in countries with increasing rates, CS tended to increase in most groups. In countries with the greatest increase in CS rates (>1%), the absolute contributions of groups 1 (nulliparous term cephalic singletons, spontaneous labour), 2a and 4a (induction of labour), 2b and 4b (prelabour CS) and 10 (preterm cephalic singletons) to the overall CS rate tended to increase. CONCLUSIONS: The TGCS shows varying CS trends and rates among countries of Europe. Comparisons between European countries, particularly those with differing trends, could provide insight into strategies to reduce CS without clinical indication.

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.

Vaginal Birth at Term - Part 2. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020).

Purpose This guideline aims to summarize the current state of knowledge about vaginal birth at term. The guideline focuses on definitions of the physiological stages of labor as well as differentiating between various pathological developments and conditions. It also assesses the need for intervention and the options to avoid interventions. The second part of this guideline presents recommendations and statements on care during the dilation and expulsion stages as well as during the placental/postnatal stage. Methods The German recommendations largely reproduce the recommendations of the National Institute for Health and Care Excellence (NICE) CG190 guideline "Intrapartum care for healthy women and babies". Other international guidelines were also consulted in individual cases when compiling this guideline. In addition, a systematic search and analysis of the literature was carried out using PICO questions where necessary, and other systematic reviews and individual studies were taken into account. For easier comprehension, the assessment tools of the Scottish Intercollegiate Guidelines Network (SIGN) were used to evaluate the quality of additionally consulted studies. Otherwise, the GRADE system was used for the NICE guideline, and the evidence reports of the IQWiG were used to evaluate the quality of the evidence. Recommendations Recommendations and statements were formulated based on identified evidence and/or a structured consensus.

Vaginal Birth at Term - Part 1. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020).

Purpose This guideline aims to summarize the current state of knowledge about vaginal birth at term. The guideline focuses on definitions of the physiological stages of labor as well as differentiating between various pathological developments and conditions. It also assesses the need for intervention and the options to avoid interventions. This first part presents recommendations and statements about patient information and counselling, general patient care, monitoring of patients, pain management and quality control measures for vaginal birth. Methods The German recommendations largely reproduce the recommendations of the National Institute for Health and Care Excellence (NICE) CG 190 guideline "Intrapartum care for healthy women and babies". Other international guidelines were also consulted in specific cases when compiling this guideline. In addition, a systematic search and analysis of the literature was carried out using PICO questions, if this was considered necessary, and other systematic reviews and individual studies were taken into account. For easier comprehension, the assessment tools of the Scottish Intercollegiate Guidelines Network (SIGN) were used to evaluate the quality of the additionally consulted studies. Otherwise, the GRADE system was used for the NICE guideline and the evidence reports of the IQWiG were used to evaluate the quality of the evidence. Recommendations Recommendations and statements were formulated based on identified evidence and/or a structured consensus.

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.

[Legal principles and decision making of the Federal Joint Committee on minimum caseloads in operative medicine]. / Gesetzliche Grundlagen und Entscheidungsfindung des Gemeinsamen Bundesausschusses zu Mindestmengen in der operativen Medizin.

Minimum caseload requirements represent a regulatory instrument of the Federal Joint Committee in order to improve patient safety for elective, highly complex procedures or treatments. A relationship between case volume and quality of the outcome must be demonstrated within the scientific literature before minimum caseload requirements can be implemented. Furthermore, patients need to be allocated to hospitals which perform higher case volumes but without causing temporal and/or transport distress for them. The recent Health Care Development Act has opened up new opportunities to combine minimum caseload requirements with each other along with structure, process and outcome quality. The surgical community can provide a contribution to this structuring process.

Prevalence and Infant Mortality of Major Congenital Malformations Stratified by Birthweight.

BACKGROUND: Low birthweight and major congenital malformations (MCMs) are key causes of infant mortality. OBJECTIVES: The aim of this study was to explore the prevalence of MCMs in infants with low and very low birthweight and analyze the impact of MCMs and birthweight on infant mortality. METHODS: We determined prevalence and infant mortality of 28 life-threatening MCMs in very-low-birthweight (<1,500 g, VLBW), low-birthweight (1,500-2,499 g, LBW), or normal-birthweight (≥2,500 g, NBW) infants in a cohort of 2,727,002 infants born in Germany in 2006-2017, using de-identified administrative data of the largest statutory public health insurance system in Germany. RESULTS: The rates of VLBW, LBW, and NBW infants studied were 1.3% (34,401), 4.0% (109,558), and 94.7% (2,583,043). MCMs affected 0.5% (13,563) infants, of whom >75% (10,316) had severe congenital heart disease. The prevalence (per 10,000) of any/cardiac MCM was increased in VLBW (286/176) and LBW (244/143), as compared to NBW infants (38/32). Infant mortality rates were significantly higher in infants with an MCM, as opposed to infants without an MCM, in each birthweight group (VLBW 28.5% vs. 11.5%, LBW 16.7% vs. 0.9%, and NBW 8.6% vs. 0.1%). For most MCMs, observed survival rates in VLBW and LBW infants were lower than expected, as calculated from survival rates of VLBW or LBW infants without an MCM, and NBW infants with an MCM. CONCLUSIONS: Infants with an MCM are more often born with LBW or VLBW, as opposed to infants without an MCM. Many MCMs carry significant excess mortality when occurring in VLBW or LBW infants.

Caesarean Section. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/084, June 2020).

Purpose This is an official S3-guideline of the German Society of Gynaecology and Obstetrics (DGGG), the Austrian Society of Gynaecology and Obstetrics (ÖGGG) and the Swiss Society of Gynaecology and Obstetrics (SGGG). The guideline contains evidence-based information and recommendations on indications, complications, methods and care associated with delivery by caesarean section for all medical specialties involved as well as for pregnant women. Methods This guideline has adapted information and recommendations issued in the NICE Caesarean Birth guideline. This guideline also considers additional issues prioritised by the Cochrane Institute and the Institute for Research in Operative Medicine (IFOM). The evaluation of evidence was based on the system developed by the Scottish Intercollegiate Guidelines Network (SIGN). A multi-part nominal group process moderated by the AWMF was used to compile this S3-level guideline. Recommendations Recommendations on consultations, indications and the process of performing a caesarean section as well as the care provided to the mother and neonate were drawn up.

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.

[What is the Optimal Minimum Provider Volume in the Provision of Care for Preterm Infants with a Birth Weight below 1250 g in Germany?] / Wie hoch ist die optimale Mindestmenge für die Behandlung Frühgeborener mit einem Geburtsgewicht unter 1250 g in Deutschland?

INTRODUCTION: Numerous studies have investigated volume-outcome relationships in the treatment of very low birth weight infants. However, studies addressing the identification of optimal thresholds when introducing minimum provider volumes for treatment of these infants do not exist. METHODS: Publicly available data (www.perinatalzentren.org) of more than 56,000 infants weighing less than 1250 g at birth (NB<1250) and treated in level-1 perinatal centers (highest level in Germany) between 2010 and 2018 was used for statistical analysis. Potentially avoidable deaths after the introduction of minimum provider volumes were calculated by deducting observed deaths from estimated deaths based on logistic regression models for every existing empirical provider volume. Various smoothing functions were used to ascertain optimal thresholds for minimum provider volumes. RESULTS: Independent of the observation period or smoothing technique, the highest number of potentially avoidable deaths was observed for minimum provider volumes of 50-60 NB<1250 per year. Introducing a minimum provider volume of 50 without a transition period would reduce the number of level-1 perinatal centers to a quarter of the current number in Germany. Approximately 60% of NB<1250 would have to be reallocated. CONCLUSION: Analyses of resulting geographical distances are needed in the preparation of minimum provider volumes for treatment of NB<1250 in Germany. Such analyses should include perinatal centers expected to reach minimum provider volumes after subsequent reallocation in the future.

[Quality Assurance Using Administrative/Routine Data for Cholelithiasis - Changes Over Time and Current Status]. / Qualitätssicherung mit Routinedaten bei Cholelithiasis ­ Veränderungen und aktueller Stand.

Quality assurance using administrative/routine data (QSR) is a relatively new measure to assess outcome quality. This approach is methodologically distinct from external quality assurance, as well as from quality assurance based upon registries. Since 2011, QSR for cholelithiasis within AOK patients has been overseen by the Scientific Institute of the AOK (WIdO). Following the introduction of an expert panel in 2013, numerous changes were put into place, whereby the indicator rates for transfusion/bleeding, various complications as well as the overall indicator were reduced. Interestingly, the risk adjusted quality differences between hospitals remained solid.

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.

[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.

Mortality and Major Morbidity of Very-Low-Birth-Weight Infants in Germany 2008-2012: A Report Based on Administrative Data.

BACKGROUND: Expectant parents of very preterm infants, physicians, and policy makers require estimates for chances of survival and survival without morbidity. Such estimates should derive from a large, reliable, and contemporary data base of easily available items known at birth. OBJECTIVE: To determine short-term outcome and risk factors in very-low-birth-weight preterm infants based on administrative data. METHODS: Anonymized routine data sets transmitted from hospital administrations to statutory health insurance companies were used to assess survival and survival free of major morbidities in a large cohort of preterm infants in Germany. RESULTS: After exclusion of infants with lethal malformations, there were 13,147 infants with a birth weight below 1,500 g admitted to neonatal care 2008-2012, of whom 1,432 infants (10.9%) died within 180 days. Estimated 180 days survival probabilities were 0.632 (95% confidence interval 0.583-0.677) for infants with 250-499 g birth weight, 0.817 (0.799-0.834) for 500-749 g, 0.931 (0.920-0.940) for 750-999 g, 0.973 (0.967-0.979) for 1,000-1,249 g, and 0.985 (0.981-0.988) for 1,250-1,499 g. Estimated probabilities for survival without major morbidity (surgically treated intraventricular hemorrhage, necrotizing enterocolitis, intestinal perforation, or retinopathy) were 0.433 (0.384-0.481) for 250-499 g, 0.622 (0.600-0.643) for 500-749 g, 0.836 (0.821-0.849) for 750-999 g, 0.938 (0.928-0.946) for 1,000-1,249 g, and 0.969 (0.964-0.974) for 1,250-1,499 g, respectively. Prediction of survival and survival without major morbidities was moderately improved by adding sex, small for gestational age, and severe or moderate congenital malformation, increasing receiver operating characteristic areas under the curve from 0.839 (0.827-0.850) to 0.862 (0.852-0.874) (survival) and from 0.827 (0.822-0.842) to 0.852 (0.846-0.863) (survival without major morbidities), respectively. CONCLUSION: The present analysis encourages attempts to use administrative data to investigate the association between risk factors and outcome in preterm infants.