Interrupted time series study found mixed effects of the impact of the Bavarian smoke-free legislation on pregnancy outcomes.

In 2007 the German government passed smoke-free legislation, leaving the details of implementation to the individual federal states. In January 2008 Bavaria implemented one of the strictest laws in Germany. We investigated its impact on pregnancy outcomes and applied an interrupted time series (ITS) study design to assess any changes in preterm birth, small for gestational age (primary outcomes), and low birth weight, stillbirth and very preterm birth. We included 1,236,992 singleton births, comprising 83,691 preterm births and 112,143 small for gestational age newborns. For most outcomes we observed unclear effects. For very preterm births, we found an immediate drop of 10.4% (95%CI - 15.8, - 4.6%; p = 0.0006) and a gradual decrease of 0.5% (95%CI - 0.7, - 0.2%, p = 0.0010) after implementation of the legislation. The majority of subgroup and sensitivity analyses confirm these results. Although we found no statistically significant effect of the Bavarian smoke-free legislation on most pregnancy outcomes, a substantial decrease in very preterm births was observed. We cannot rule out that despite our rigorous methods and robustness checks, design-inherent limitations of the ITS study as well as country-specific factors, such as the ambivalent German policy context have influenced our estimation of the effects of the legislation.

Incidence and risk factors of cerebral sinovenous thrombosis in infants.

AIM: To describe the incidence of term and preterm neonatal cerebral sinovenous thrombosis (CSVT) and identify perinatal risk factors. METHOD: This was a national capture-recapture calculation-corrected surveillance and nested case-control study. Infants born preterm and at term with magnetic resonance imaging-confirmed neonatal CSVT were identified by surveillance in all paediatric hospitals in Germany (2015-2017). Incidence was corrected for underreporting using a capture-recapture method in one federal state and then extrapolated nationwide. We reviewed PubMed for comparisons with previously reported incidence estimators. We used a population-based perinatal database for quality assurance to select four controls per case and applied univariate and multivariable regression for risk factor analysis. RESULTS: Fifty-one newborn infants (34 males, 17 females; 14 born preterm) with neonatal CSVT were reported in the 3-year period. The incidence of term and preterm neonatal CSVT was 6.6 (95% confidence interval [CI] 4.4-8.7) per 100 000 live births. Median age at time of confirmation of the diagnosis was 9.95 days (range 0-39d). In the univariate analysis, male sex, preterm birth, hypoxia and related indicators (umbilical artery pH <7.1; 5-minute Apgar score <7; intubation/mask ventilation; perinatal asphyxia), operative vaginal delivery, emergency Caesarean section, and pathological fetal Doppler sonography were associated (p<0.05) with neonatal CSVT. Multivariable regression yielded hypoxia (odds ratio=20.3; 95% CI 8.1-50.8) as the independent risk factor. INTERPRETATION: Incidence of neonatal CSVT was within the range of other population-based studies. The results suggest that hypoxia is an important perinatal risk factor for the aetiology of neonatal CSVT.

Associations of area-level deprivation with adverse obstetric and perinatal outcomes in Bavaria, Germany: Results from a cross-sectional study.

BACKGROUND: We investigated associations of area-level deprivation with obstetric and perinatal outcomes in a large population-based routine dataset. METHODS: We used the data of n = 827,105 deliveries who were born in hospitals between 2009 to 2016 in Bavaria, Germany. The Bavarian Index of Multiple Deprivation (BIMD) on district level was assigned to each mother by the zip code of her residential address. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) for preterm deliveries, Caesarian sections (CS), stillbirths, small for gestational age (SGA) births and low 5-minute Apgar scores by BIMD quintiles with and without adjustment for potential confounders. RESULTS: We observed a significantly increased risk for preterm deliveries in mothers from the most deprived compared to the least deprived districts (e.g. OR [95% CI] for highest compared to lowest deprivation quintile: 1.06 [1.03, 1.09]) in adjusted analyses. Increased deprivation was also associated with higher SGA and secondary CS rates, but with lower proportions of stillbirths, primary CS and low Apgar scores. When one large clinic with an unusually high stillbirth rate was excluded, the association of BIMD with stillbirths was attenuated and almost disappeared. CONCLUSIONS: We found that area-level deprivation in Bavaria was positively associated with preterm and SGA births, confirming previous studies. In contrast, the finding of an inverse association between deprivation and both stillbirth rates and low Apgar score came somewhat surprising. However, we conclude that the stillbirths finding is spurious and reflects regional bias due to a clinic which seems to specialize in termination of pregnancies.

Statistical process monitoring to improve quality assurance of inpatient care.

BACKGROUND: Statistical Process Monitoring (SPM) is not typically used in traditional quality assurance of inpatient care. While SPM allows a rapid detection of performance deficits, SPM results strongly depend on characteristics of the evaluated process. When using SPM to monitor inpatient care, in particular the hospital risk profile, hospital volume and properties of each monitored performance indicator (e.g. baseline failure probability) influence the results and must be taken into account to ensure a fair process evaluation. Here we study the use of CUSUM charts constructed for a predefined false alarm probability within a single process, i.e. a given hospital and performance indicator. We furthermore assess different monitoring schemes based on the resulting CUSUM chart and their dependence on the process characteristics. METHODS: We conduct simulation studies in order to investigate alarm characteristics of the Bernoulli log-likelihood CUSUM chart for crude and risk-adjusted performance indicators, and illustrate CUSUM charts on performance data from the external quality assurance of hospitals in Bavaria, Germany. RESULTS: Simulating CUSUM control limits for a false alarm probability allows to control the number of false alarms across different conditions and monitoring schemes. We gained better understanding of the effect of different factors on the alarm rates of CUSUM charts. We propose using simulations to assess the performance of implemented CUSUM charts. CONCLUSIONS: The presented results and example demonstrate the application of CUSUM charts for fair performance evaluation of inpatient care. We propose the simulation of CUSUM control limits while taking into account hospital and process characteristics.

Risk factors for perinatal arterial ischaemic stroke: a large case-control study.

AIM: To identify maternal, obstetric, and neonatal risk factors related to perinatal arterial ischaemic stroke (PAIS) diagnosed within 28 days after birth and to understand the underlying pathophysiology. METHOD: For case and control ascertainment, we used active surveillance in 345 paediatric hospitals and a population-based perinatal database for quality assurance of hospital care. We analysed complete cases of PAIS using logistic regression. Multivariate analysis was guided by a directed acyclic graph. RESULTS: After exclusion of records with missing data, we analysed 134 individuals with PAIS and 576 comparison individuals. In univariate analysis, male sex, preterm birth (<37wks gestational age), small for gestational age (SGA), low umbilical artery pH (<7.1), low 5-minute-Apgar score (<7), multiple pregnancies, hypoxia, intubation/mask ventilation, nulliparity, Caesarean section, vaginal-operative delivery, chorioamnionitis, and oligohydramnios were associated with an increased risk. Mutual adjustment yielded male sex (odds ratio [OR] 1.81; 95% confidence interval [CI] 1.20-2.73), multiple birth (OR 3.22; 95% CI 1.21-8.58), chorioamnionitis (OR 9.89; 95% CI 2.88-33.94), preterm birth (OR 1.86; 95% CI 1.01-3.43), and SGA (OR 3.05; 95% CI 1.76-5.28) as independent risk factors. INTERPRETATION: We confirmed the increased risk in males and the role of chorioamnionitis and SGA for PAIS, pointing to the importance of inflammatory processes and fetal-placental insufficiency. Multiple birth and preterm birth were additional risk factors. WHAT THIS PAPER ADDS: Chorioamnionitis and small for gestational age (SGA) precede perinatal arterial ischaemic stroke (PAIS). Chorioamnionitis and SGA are independent risk factors for PAIS. Inflammatory processes and fetal-placental insufficiency are the likely underlying mechanisms. Multiple birth and preterm birth are additional risk factors.

Does charge-free screening improve detection of gestational diabetes in women from deprived areas: a cross-sectional study.

BACKGROUND: Gestational diabetes mellitus (GDM) occurs in 2-6 % of all pregnancies. We investigated whether area level deprivation is associated with a higher risk for GDM and whether GDM detection rates in deprived regions changed after the introduction of charge-free GDM screening in Germany in 2012. METHODS: We analyzed population-based data from Bavaria, Germany, comprising n = 587,621 deliveries in obstetric units between 2008 and 2014. Area level deprivation was assessed municipality-based using the Bavarian Index of Multiple Deprivation (BIMD), divided into quintiles and assigned to each mother based on her residential address. We estimated annual odds ratios (ORs) for GDM diagnosis by BIMD quintile with adjustment for maternal obesity, maternal age, migration background and single mother status. RESULTS: Women from the most deprived regions were less likely to be diagnosed with GDM before introduction of charge-free GDM screening (OR = 0.76 [95 % confidence interval: 0.66, 0.86] compared to least deprived areas), in 2008. In contrast, high area level deprivation was associated with significantly increased risk of GDM diagnosis in 2013 (OR [95 % confidence interval] = 1.15 [1.02, 1.29]). The OR was also elevated, although not significantly, in 2014 (OR [95 % confidence interval] = 1.05 [0.93, 1.18]). CONCLUSIONS: The prevalence of GDM seems to have been underreported in women from highly deprived areas before introduction of the charge-free GDM screening in Germany. In fact, women living in deprived regions seem to have an increased risk for GDM and may profit from access to charge-free GDM screening.

Declines in stillbirth and neonatal mortality rates in Europe between 2004 and 2010: results from the Euro-Peristat project.

BACKGROUND: Stillbirth and neonatal mortality rates declined in Europe between 2004 and 2010. We hypothesised that declines might be greater for countries with higher mortality in 2004 and disproportionally affect very preterm infants at highest risk. METHODS: Data about live births, stillbirths and neonatal deaths by gestational age (GA) were collected using a common protocol by the Euro-Peristat project in 2004 and 2010. We analysed stillbirths at ≥28 weeks GA in 22 countries and live births ≥24 weeks GA for neonatal mortality in 18 countries. Per cent changes over time were assessed by calculating risk ratios (RR) for stillbirth, neonatal mortality and preterm birth rates in 2010 vs 2004. We used meta-analysis techniques to derive pooled RR using random-effects models overall, by GA subgroups and by mortality level in 2004. RESULTS: Between 2004 and 2010, stillbirths declined by 17% (95% CI 10% to 23%), with a range from 1% to 39% by country. Neonatal mortality declined by 29% (95% CI 23% to 35%) with a range from 9% to 67%. Preterm birth rates did not change: 0% (95% CI -3% to 3%). Mortality declines were of a similar magnitude at all GA; mortality levels in 2004 were not associated with RRs. CONCLUSIONS: Stillbirths and neonatal deaths declined at all gestational ages in countries with both high and low levels of mortality in 2004. These results raise questions about how low-mortality countries achieve continued declines and highlight the importance of improving care across the GA spectrum.

Interinstitutional variations in mode of birth after a previous caesarean section: a cross-sectional study in six German hospitals.

AIMS: Regional and interinstitutional variations have been recognized in the increasing incidence of caesarean section. Modes of birth after previous caesarean section vary widely, ranging from elective repeat caesarean section (ERCS) and unplanned repeat caesarean section (URCS) after trial of labour to vaginal birth after caesarean section (VBAC). This study describes interinstitutional variations in mode of birth after previous caesarean section in relation to regional indicators in Germany. MATERIAL AND METHODS: A cross-sectional study using the birth registers of six maternity units (n=12,060) in five different German states (n=370,209). Indicators were tested by χ2 and relative deviations from regional values were expressed as relative risks and 95% confidence intervals. RESULTS: The percentages of women in the six units with previous caesarean section ranged from 11.9% to 15.9% (P=0.002). VBAC was planned for 36.0% to 49.8% (P=0.003) of these women, but actually completed in only 26.2% to 32.8% (P=0.66). Depending on the indicator, the units studied deviated from the regional data by up to 32% [relative risk 0.68 (0.47-0.97)] in respect of completed VBAC among all initiated VBAC. CONCLUSIONS: There is substantial interinstitutional variation in mode of birth following previous caesarean section. This variation is in addition to regional patterns.

Varying gestational age patterns in cesarean delivery: an international comparison.

BACKGROUND: While international variations in overall cesarean delivery rates are well documented, less information is available for clinical sub-groups. Cesarean data presented by subgroups can be used to evaluate uptake of cesarean reduction policies or to monitor delivery practices for high and low risk pregnancies based on new scientific evidence. We studied differences and patterns in cesarean delivery rates by multiplicity and gestational age in Europe and the United States. METHODS: This study used routine aggregate data from 17 European countries and the United States on the number of singleton and multiple live births with cesarean versus vaginal delivery by week of gestation in 2008. Overall and gestation-specific cesarean delivery rates were analyzed. We computed rate differences to compare mode of delivery (cesarean vs vaginal birth) between selected gestational age groups and studied associations between rates in these subgroups namely: very preterm (26-31 weeks GA), moderate preterm (32-36 weeks GA), near term (37-38 weeks GA), term (39-41 weeks GA) and post-term (42+ weeks GA) births, using Spearman's rank tests. RESULTS: High variations in cesarean rates for singletons and multiples were observed everywhere. Rates for singletons varied from 15% in The Netherlands and Slovenia, to over 30% in the US and Germany. In singletons, rates were highest for very preterm births and declined to a nadir at 40 weeks of gestation, ranging from 8.0% in Sweden and Norway, to 22.5% in the US. These patterns differed across countries; the average rate difference between very preterm and term births was 43 percentage points, but ranged from 14% to 61%. High variations in rate differences were also observed for near term versus term births. For multiples, rates declined by gestational age in some countries, whereas in others rates were similar across all weeks of gestation. Countries' overall cesarean rates were highly correlated with gestation-specific subgroup rates, except for very preterm births. CONCLUSIONS: Gestational age patterns in cesarean delivery were heterogeneous across countries; these differences highlight areas where consensus on best practices is lacking and could be used in developing strategies to reduce cesareans.

Relevance of hospital characteristics as performance indicators for treatment of very-low-birth-weight neonates.

BACKGROUND: Current attempts at centralization of neonatal care in Germany focus on a minimum volume of 30 very-low-birth-weight (VLBW, weighing <1250 g) neonate admissions per year. However, the evidence for a selective referral strategy based on hospital volume is unclear. METHOD: A total of 5575 neonates weighing <1250 g treated in 31 hospitals in Bavaria between 2000 and 2011 were analysed using population-based data. The relevance of different hospital characteristics (i.e. hospital volume, bed capacity and teaching status) for explaining individual in-hospital mortality as well as interhospital variation in mortality rates was analysed using multilevel logistic regression analysis. RESULTS: In a risk-adjusted model, only dichotomized hospital volume (<30 admissions) was significantly associated with higher mortality in VLBW neonates (odds ratio: 1.74; 95% confidence interval: 1.02-2.99). However, the higher mortality risk only applied to neonates with higher Clinical Risk Index for Babies (CRIB) scores. There was considerable heterogeneity in mortality rates between Bavarian hospitals. The median odds ratio for mortality between two neonates treated in a randomly chosen low-performing versus high-performing hospital was 1.62 in the null model (without explanatory variables). Hospital volume only explained 15.1% of interhospital variation in mortality rates after adjustment for case-mix. Other hospital characteristics were of minor relevance. A funnel plot of the standardized mortality ratio against the number of admissions showed that 41% of small-volume hospitals performed better than expected. CONCLUSION: A selective referral strategy based solely on hospital volume will fall short of the task of optimal allocation of neonatal care by means of centralization.

Reporting of perinatal health indicators for international comparisons--enhancing the appearance of geographical plots.

BACKGROUND: Tabulating annual national health indicators sorted by outcome may be misleading for two reasons. The implied rank order is largely a result of heterogeneous population sizes. Distinctions between geographically adjacent regions are not visible. METHODS: Regional data are plotted in a geographical map shaded in terms of percentiles of the indicator value. Degree of departure is determined relative to control limits of a corresponding funnel plot. Five methods for displaying outcome and degree of departure from a reference level are proposed for four indicators selected from the 2004 European Perinatal Health Report. RESULTS: Spread of indicator values was generally largest for small population sizes, with results for large populations lying mostly close to respective European medians. The high neonatal mortality rate for Poland (4.9 per 1000); high low-birthweight rates for England and Wales (7.8%), Germany (7.3%) and Estonia (4.5%); and high caesarean section rates for Italy (37.8%), Poland (26.3%), Portugal (33.1%) and Germany (27.3%) were statistically significant exceptions to this pattern. Estonia also showed an extreme result for maternal mortality (29.6 per 100 000). CONCLUSION: Extreme deviations from EU reference levels are either correlated with small population sizes or may be interpreted in terms of differing medical practices, as in the case of caesarean section rate. EURO-PERISTAT has now decided to use 5-year averages for maternal mortality to reduce the variance in outcome. Use of two colours in three intensities and solid fill versus crosshatching is best suited to display rate and significance of difference.

Within-population average ranges compared with Institute of Medicine recommendations for gestational weight gain.

OBJECTIVE: To compare the risk for pregnancy outcomes by gestational weight gain with the Institute of Medicine criteria and empirically established average ranges of gestational weight gain. METHODS: In a population-based data set comprising 678,560 singleton deliveries in Bavarian obstetric units from 2000 to 2007, we calculated the prevalence of adverse short-term pregnancy outcomes within the gestational weight-gain ranges recommended by the Institute of Medicine. We then compared these for gestational weight gain within data-based interquartile ranges (25th to 75th percentile) and interdecile ranges (10th to 90th percentile) of gestational weight gain by maternal weight category (underweight, normal weight, overweight, and obese). RESULTS: In underweight and normal-weight mothers, adherence to Institute of Medicine criteria was significantly associated with fewer preterm deliveries and small-for-gestational-age births (prevalence [95% confidence interval] for preterm delivery in normal-weight women: 5.33 [5.23-5.43] within Institute of Medicine criteria compared with 5.45 [5.36-5.54] in interquartile range). Overweight and obese mothers gaining weight within the Institute of Medicine recommendations had less preeclampsia and nonelective caesarean deliveries but had higher risks for gestational diabetes, small-for-gestational-age births, preterm delivery, and perinatal mortality compared with gestational weight gain within the respective interquartile ranges and interdecile ranges (prevalence for preterm delivery in overweight women: 8.14% [7.87-8.42] within Institute of Medicine criteria compared with 5.77% [5.60-5.93] in interquartile range). CONCLUSION: Although underweight and normal-weight women should be encouraged to aim for a gestational weight gain according to Institute of Medicine guidelines, different gestational weight gain recommendations in overweight and obese women might lessen some adverse short-term pregnancy outcomes. LEVEL OF EVIDENCE: II.

[An analysis of the effectiveness of external quality assurance programmes using changes in quality indicators of individual hospitals]. / Wirksamkeitsanalyse externer Qualitätssicherungsmaßnahmen anhand von Veränderungen in Qualitätskennzahlen einzelner Krankenhäuser.

Judging the effectiveness of external quality assurance programmes by comparing current performance with unadjusted regional or national crude averages is misleading because the influence of the actual size of the populations under consideration as well as the variance of performance between hospitals is underestimated. Not only do these artefacts lead to a general overestimation of changes in regional averages. They also may lead to a ranking confounded by regional size. An assessment at unit level circumvents these difficulties. The differential grading of degree of departure of a unit's performance from national targets available from funnel plots allows, in addition, for the discrimination between effects due to the monitoring institution and achievements attributable to the hospital under surveillance. A central role is played by the scoring system adopted for evaluating incremental changes of performance indicator values in successive years. The following proposal is intended to both assist the assessment of effectiveness of quality assurance programmes and identify areas requiring urgent improvement. Bavarian quality assurance data (BAQ 1995) are used to illustrate the method.

Perinatal health monitoring in Europe: results from the EURO-PERISTAT project.

Data about deliveries, births, mothers and newborn babies are collected extensively to monitor the health and care of mothers and babies during pregnancy, delivery and the post-partum period, but there is no common approach in Europe. We analysed the problems related to using the European data for international comparisons of perinatal health. We made an inventory of relevant data sources in 25 European Union (EU) member states and Norway, and collected perinatal data using a previously defined indicator list. The main sources were civil registration based on birth and death certificates, medical birth registers, hospital discharge systems, congenital anomaly registers, confidential enquiries and audits. A few countries provided data from routine perinatal surveys or from aggregated data collection systems. The main methodological problems were related to differences in registration criteria and definitions, coverage of data collection, problems in combining information from different sources, missing data and random variation for rare events. Collection of European perinatal health information is feasible, but the national health information systems need improvements to fill gaps. To improve international comparisons, stillbirth definitions should be standardised and a short list of causes of fetal and infant deaths should be developed.

[Comparison of quality by means of funnel plots--a plea for a uniform methodology]. / Qualitätsvergleiche mit Funnelplots--Plädoyer für eine einheitliche Methodik.

Vertical bar charts depicting unit event rates sorted in ascending order enjoy widespread usage in external quality assurance. Unfortunately they suggest a spurious ranking resulting from instability in the percentile distribution chiefly caused by varying denominators. The popular remedy of simply excluding units below a minimum threshold would solve the problem only partially since units with few operations per annum may evade evaluation altogether merely by the grace of their size. Compared with alternative solutions reviewed in this article Spiegelhalter's funnel plots exhibit clear advantages over statistical control charts or Bayesian modelling. A major drawback of control charts at present is that data are still widely transferred on a yearly rather than a quarterly or even monthly basis. The chief disadvantage of Bayesian modelling lies in the difficulty of obtaining consensus on the required prior distributions. Funnel plots on the other hand provide a flexible and sample size dependent uniform approach while at the same time offering an intuitive interpretation of volume effects. The addition of control and warning limits allows for formal assessment of deviations from target values.

Optimal gestational weight gain ranges for the avoidance of adverse birth weight outcomes: a novel approach.

BACKGROUND: Gestational weight gain (GWG) has been shown to be directly associated with birth weight. OBJECTIVE: We aimed to define ranges for optimal GWG with respect to the risk of either small- or large-for-gestational-age offspring by using a new statistical approach. DESIGN: For the purpose of an observational study, data on n = 177,079 mature singleton deliveries in Bavaria between 2004 and 2006 were extracted from a standard data set that is regularly collected for national benchmarking of obstetric units in terms of clinical performance. Joint predicted risks of either small- or large-for-gestational-age births in relation to GWG (continuous measurement) were estimated by logistic regression models with adjustment for potential confounders. RESULTS: The estimated optimal GWG ranges as defined by a joint predicted risk of

Temporal trends in pregnancy weight gain and birth weight in Bavaria 2000-2007: slightly decreasing birth weight with increasing weight gain in pregnancy.

AIMS: To assess temporal trends in birth weight and pregnancy weight gain in Bavaria from 2000 to 2007. METHODS: Data on 695,707 mother and infant pairs (singleton term births) were available from a compulsory reporting system for quality assurance, including information on birth weight, maternal weight at delivery and at booking, maternal smoking, age, and further anthropometric and lifestyle factors. Pregnancy weight gain was defined as: weight prior to delivery minus weight at first booking minus weight of the newborn. RESULTS: Although mean weight gain during pregnancy increased considerably from 10.10 to 10.73 kg in seven years, the mean birth weight in mature singletons decreased slightly from 3433 to 3414 g. These trends could not be explained by concurrent changes in the rates of primiparity, smoking and gestational diabetes. CONCLUSIONS: These German data confirm an increased weight gain during pregnancy with adjustment for potential confounders.

Stillbirth following previous cesarean section in Bavaria/Germany 1987-2005.

BACKGROUND: An elevated risk for unexplained stillbirth in subsequent pregnancies after cesarean section was reported in 2003. This finding would imply renewed discussions about stronger indications for cesarean sections. OBJECTIVE: To find out whether there is an elevated risk for stillbirth in subsequent pregnancies after cesarean section in our cohort in Bavaria. METHODS: As data linkage of records is not possible in Germany, we devised a suitable adjustment for bias correction. Second pregnancies in Bavaria/Germany after previous vaginal birth and previous cesarean section from 1987 to 2005 were analyzed. Risk of unexplained stillbirth was estimated by time-to-event analysis. RESULTS: In our cohort of 629,815 second pregnancies, no elevated stillbirth risk in pregnancies after previous cesarean section compared to previous vaginal birth was noted (crude risk 0.22% in both groups; hazard ratio (HR) 1.00; P = 1.0). A slightly decreased risk for stillbirth after previous cesarean section for the period of 1994-2005 (HR 0.674; P = 0.04) could be shown. CONCLUSION: We found no elevated stillbirth risk in pregnancies after previous cesarean section. The significantly lower risk for stillbirths after previous cesarean section in the period 1994-2005 is interpreted as consequence of improved obstetric surveillance. With our adjustment for bias correction, we hope to have found a way to make our data largely comparable with other sources reported in the literature. However, because of the strict German data protection act, the Bavarian birth register is only of limited use for the presented study.

Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients.

PURPOSE: Transurethral resection of the prostate has for decades been the standard surgical therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia, the most common benign neoplasm in men. To generate a contemporary reference for evolving medical and minimally invasive therapies we analyzed complications and immediate outcomes of transurethral prostate resection in a statewide multicenter study. MATERIALS AND METHODS: We prospectively evaluated 10,654 patients undergoing transurethral prostate resection in the state of Bavaria, Germany from January 1, 2002 until December 31, 2003. Case records containing 54 items concerning preoperative status, operation details, complications and immediate outcome, were recorded for each patient. RESULTS: The mortality rate for transurethral prostate resection was 0.10%. The cumulative short-term morbidity rate was 11.1%. The most relevant complications were failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%) and transurethral resection syndrome (1.4%). The resected tissue averaged 28.4 gm. Incidental carcinoma of the prostate was diagnosed by histological examination in 9.8% of patients. Urinary peak flow rate increased significantly to 21.6 +/- 9.4 ml per second (baseline 10.4 +/- 6.8 ml per second, 1 tail p <0.0001), while post-void residual decreased to 31.1 +/- 73.0 ml (baseline 180.3 +/- 296.9 ml, 1-tail p <0.0001). CONCLUSIONS: In a large scale evaluation comprising 44 mostly nonacademic urological departments in Bavaria, unique real-world data for transurethral prostate resection were prospectively generated. This most contemporary information should be of use to potential patients and facilitate subsumption of emerging surgical and nonsurgical benign prostatic hyperplasia treatment options.

The association of psychosocial factors with nausea and vomiting during pregnancy.

OBJECTIVES: The purpose of this study was to identify predictors for nausea and vomiting during pregnancy (NVP). STUDY DESIGN: A large German health insurance company provided data on prescription reimbursements and socio-demographics for all women giving birth between June 2000 and May 2001. The prescribed drugs were classified according to the Anatomical Therapeutic Chemical (ATC) code. The data was linked to the database of the Bavarian Perinatal Study in psychosocial variables as possible predictors of NVP. RESULTS: The risk of developing NVP was two times higher for non-smokers than for smokers (OR=2.03 KI [1.02-4.05]) and dropped about 3% (OR=0.97 KI [0.94-0.99]) with every year of age. Being single raised the risk of NVP by about 50% (OR=1.49 KI [1.24-1.79]) compared to women who lived with a partner, and among these women living alone, working lowered the adjusted risk about two thirds (OR=0.34 KI [0.24-0.49]) compared to women who did not work. CONCLUSION: Psychosocial variables have a clear influence on nausea and vomiting during pregnancy. Physicians should be aware of this fact when seeing women asking for treatment.