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Background: There are no data on recent trends in the incidence rate of type 2 diabetes (T2D) in Germany. The aim of this study was to determine the sex-, age-, and region-specific trends in the T2D incidence rate between 2014 and 2019. Methods: Based on nationwide data from statutorily insured persons in Germany, negative binomial regression models were used to analyze age- and sex-specific trends in the T2D incidence rate. Age- and sex-adjusted trends were calculated for 401 administrative districts using a Bayesian spatio-temporal regression model. Results: During the period concerned, approximately 450 000 new cases of T2D were observed each year among some 63 million persons. Taking all age groups together, the incidence rate decreased in both women and men, from 6.9 (95% confidence interval [6.7; 7.0]) and 8.4 [8.2; 8.6] respectively per 1000 persons in 2014 to 6.1 [5.9; 6.3] and 7.7 [7.5; 8.0] per 1000 persons in 2019. This corresponds to an annual reduction of 2.4% [1.5; 3.2] for women and 1.7% [0.8; 2.5] for men. The incidence rate increased in the age group 20--39 years. The age- and sex-adjusted incidence rate decreased in almost all districts, although regional differences persisted. Conclusion: The T2D incidence rate should be closely monitored to see whether the decreasing trend continues. One must not forget that the prevalence can rise despite decreasing incidence. For this reason, the findings do not necessarily mean a decrease in the disease burden of T2D and the associated demand on healthcare resources. [ABSTRACT FROM AUTHOR]

Background: The findings of observational studies can be distorted by a number of factors. So-called confounders are well known, but distortion by collider bias (CB) has received little attention in medical research to date. The goal of this article is to present the principle of CB, and measures that can be taken to avoid it, by way of a few illustrative examples. Methods: The findings of a selective review of the literature on CB are explained with illustrative examples. Results: The simplest case of a collider variable is one that is caused by at least two other variables. An example of CB is the observation that, among persons with diabetes, obesity is associated with lower mortality, even though it is associated with higher mortality in the general population. The false protective association between obesity and mortality arises from the restriction of the study population to persons with diabetes. Conclusion: CB is a distortion that arises through restriction on or stratification by a collider variable, or through statistical adjustment for a collider variable in a regression model. CB can arise in many ways. The graphic representation of causal structures helps to identify potential sources of CB. It is important to distinguish confounders from colliders, as methods that serve to correct for confounding can themselves cause bias when applied to colliders. There is no generally applicable method for correcting CB. [ABSTRACT FROM AUTHOR]

Background and Aims: In a non-interventional study of older persons, we assessed the impact of changes in BMI and waist circumference (WC) on reversion from glucose- and HbA1c-defined prediabetes to normoglycaemia (in short: reversion) and on persistence of normoglycaemia. Moreover, we studied whether reversion reduced cardiovascular risk.Methods and Results: From the population-based KORA S4/F4/FF4 cohort study conducted in Southern Germany, we utilized data from the second and third visit to the study center (median follow-up 6.5 years). We used two overlapping data sets, one with 563 persons with HbA1c<6.5% (mean age 69 years, 51.5% men), one with 510 persons with glucose-based prediabetes or normal glucose tolerance. We calculated proportions of reversion, and estimated adjusted relative risks for the association between initial BMI/WC and change of BMI/WC, respectively, and reversion (and persistence of normoglycaemia, respectively). We estimated 10-year cardiovascular risks using the Framingham 2008 score. Overall, 27.3% of persons with HbA1c-defined prediabetes and 9.2% of persons with glucose-based prediabetes returned to normoglycaemia during follow-up. Lower initial BMI/WC and reduction of BMI/WC were associated with larger probabilities of returning to normoglycaemia (e.g., for HbA1c 5.7-6.4%, RR = 1.24 (95% CI: 1.09-1.41) per 1 kg/m2 decline of BMI). Moreover, reduction of BMI/WC increased probabilities of maintaining normoglycaemia (e.g., for glucose-based prediabetes, RR = 1.09 (1.02-1.16) per 1 kg/m2 decline of BMI). 10-year cardiovascular risk was 5.6 (1.7-9.6) percentage points lower after reversion from glucose-based prediabetes to normoglycaemia.Conclusion: In older adults, even moderate weight reduction contributes to reversion from prediabetes to normoglycaemia and to maintaining normoglycaemia. [ABSTRACT FROM AUTHOR]

The aims of this study were to analyze the prevalence and course of disordered eating behavior (DEB) in adolescents with intensively treated type I diabetes, describe differences in age-specific DEB symptoms, and identify predictors of current DEB. Data were taken from 332/218 11- to 27-year-old participants (55.7% girls/women, mean age [SD] 17.8 [3.4] years, mean diabetes duration 14.9 [3.0] years) of two/three surveys of a Germany-wide longitudinal study on early-onset and long duration diabetes, respectively. A diabetes-adapted version of the SCOFF questionnaire was used to assess DEB. Both screening-based overall and age- and sex-specific prevalence of DEB and its symptoms were determined. To estimate transition probabilities between DEB states, first-order Markov transition models were implemented adjusting for previous sociodemographic, socioeconomic, and diabetes-specific covariates. The overall screening-based DEB prevalence among all 1,318 observations was 10.8% (95% confidence interval [CI]: 9.2%, 12.6%) with age-specific differences in symptom prevalence. Transition probabilities for developing/persistent DEB were twofold higher among female than male participants (risk ratio [RR] 2.3 [1.4, 3.9]/2.1 [1.3, 3.4]). In multiple adjusted regression, previous DEB (odds ratio [OR] 2.8 [95% CI 1.4, 5.6]), follow-up time (OR per 1-year increase 3.4 [1.4, 8.0]), and sex (OR girls/women 2.1 [1.1, 3.9]) were the most important predictors of current DEB with further weaker associations for previous age and HbA 1c. Our results contribute to better understanding the course of DEB in patients with early-onset diabetes and emphasize the relevance of regular DEB screenings including the age group of young adults. [ABSTRACT FROM AUTHOR]

Abstract Objectives Although transcatheter aortic valve implantation was the treatment of choice in inoperable and high-risk patients, the effect of transcatheter aortic valve implantation relative to conventional aortic valve replacement via ministernotomy in patients with moderate surgical risk remains unclear. Methods We consecutively enrolled patients who underwent minimally invasive aortic valve replacements via ministernotomy (n = 1929), transapical (n = 607), and transfemoral (n = 1273) aortic valve implantations from a single center during the period from July 2009 to July 2017. Of those, we conducted a 1:1:1 propensity score matching according to 23 preoperative risk factors. Results We were able to find 177 triplets (n = 531). The median European System for Cardiac Operative Risk Evaluation II was 3.0% versus 3.4% versus 2.9%, and Society of Thoracic Surgeons Predicted Risk of Mortality was 3.2% versus 3.6% versus 3.4%, respectively. According to the Valve Academic Research Consortium 2 criteria, there were no significant periprocedural differences regarding 30-day mortality (2.3% minimally invasive aortic valve replacement vs 4.5% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P =.34), stroke (1.1% minimally invasive aortic valve replacement vs 0.6% transapical transcatheter aortic valve implantation vs 1.7% transfemoral transcatheter aortic valve implantation, P =.84), or myocardial infarction (0.6% minimally invasive aortic valve replacement vs 0.0% transapical transcatheter aortic valve implantation vs 0.0% transfemoral transcatheter aortic valve implantation, P =.83). Both intensive care and hospitalization times were significantly longer in the transapical group. Regarding midterm survival, transapical transcatheter aortic valve implantation was associated with a tendency toward a less favorable outcome (hazard ratio, 1.48; 95% confidence interval, 0.95-2.31; P =.17) compared with minimally invasive aortic valve replacement. Conclusions In this real-world propensity score–matched minimally invasive aortic valve replacement, transapical transcatheter aortic valve implantation, transfemoral transcatheter aortic valve implantation cohort of intermediate-risk patients, early mortality was not significantly different, whereas the rates of periprocedural complications were different depending on the approach. During follow-up, there was a tendency in the transapical transcatheter aortic valve implantation group toward a less favorable survival outcome, although there was no significant difference among the 3 groups. [ABSTRACT FROM AUTHOR]

Background: In intervention trials, only randomization guarantees equal distributions of all known and unknown patient characteristics between an intervention group and a control group and enables causal statements on treatment effects. However, randomized controlled trials have been criticized for insufficient external validity; non-randomized trials are an alternative here, but come with the danger of intervention and control groups differing with respect to known and/or unknown patient characteristics. Non-randomized trials are generally analyzed with multiple regression models, but the so-called propensity score method is now being increasingly used. Methods: The authors present, explain, and illustrate the propensity score method, using a study on coronary artery bypass surgery as an illustrative example. This article is based on publications retrieved by a selective literature search and on the authors' scientific experience. Results: The propensity score (PS) is defined as the probability that a patient will receive the treatment under investigation. In a first step, the PS is estimated from the available data, e.g. in a logistic regression model. In a second step, the actual treatment effect is estimated with the aid of the PS. Four methods are available for this task: PS matching, inverse probability of treatment weighting (IPTW), stratification by PS, and regression adjustment for the PS. Conclusion: The propensity score method is a good alternative method for the analysis of non-randomized intervention trials, with epistemological advantages over conventional regression modelling. Nonetheless, the propensity score method can only adjust for known confounding factors that have actually been measured. Equal distributions of unknown confounding factors can be achieved only in randomized controlled trials. [ABSTRACT FROM AUTHOR]

Background: The database of the German Institute of Medical Documentation and Information makes it possible for the first time to compute statistics on diabetes for all insurees of the statutory health insurance scheme in Germany. Data from this comprehensive source are less likely to be biased by differences in the membership structures of individual insurance carriers or by the under-representation of persons over age 80 that is seen in most population-based studies. Methods: International Classification of Diseases (ICD)-coded diagnosis data from the inpatient and outpatient sectors were used to define persons as having diabetes. Incidences were estimated from differences in prevalence from one year to the next and the expected mortality of persons with and without diabetes. Results: A diabetes diagnosis was present in 6.4 million out of a total of 65.6 million insurees in 2009 and in 6.7 million out of 64.9 million insures in 2010. The corresponding age and sex standardized prevalences of diabetes were 9.7% in 2009 and 9.9% in 2010, respectively. The number of persons with type 2 diabetes was 4.6 million in 2009 and 4.7 million in 2010. The prevalence and incidence of type 2 diabetes rose steeply from age 50 to age 80. Peak incidence was at age 85, with 24 newly diagnosed cases of diabetes per 1000 person-years. Conclusion: On the basis of these data, we estimate that 5.8 million persons with type 2 diabetes are living in Germany today. The database used in this study is a valuable complement to population-based studies for monitoring the prevalence of diabetes, particularly in persons over age 80. [ABSTRACT FROM AUTHOR]

Purpose: This trial investigated the effect of a stroke support service on physical functioning in post-stroke outpatients. Methods: The randomized trial took place in two urban hospitals in Germany. The intervention covered a post-discharge stroke support service including following components: outreach work (via telephone contact and home-visit), informational events, training sessions, online portal, and written patient information. The control group received optimized standard care by written patient information. The primary outcome measure was physical function assessed by the physical scale of the stroke impact scale (SIS) 2.0 at baseline and after 12 months follow-up. Secondary outcomes covered health-related quality of life, depression, somatization, reinfarcts, and mortality. Use of health services was recorded. Results: A total of 265 patients were randomized either to the intervention (n = 130) or to the control group (n = 135);n = 230 patients were analyzed after 12 months. The mean group difference on the physical SIS scale was − 2.7 points (95% CI, − 5.5–0.2) in favor of the control group. The overall risk of mortality in the control versus the intervention group was 11.6and 3.9%, respectively (hazard ratio 0.32, 95% CI, 0.12–0.88). All other outcomes were neither statistically nor clinically relevant, different between the two study groups. Conclusion: An additional stroke support service did not improve physical function, health-related quality of life, depression, somatization, or reinfarcts in stroke patients. Data suggest a lower overall risk of mortality in the intervention group. [ABSTRACT FROM AUTHOR]

Background: Limited information exists on the influence of preoperative renal dysfunction on in-hospital mortality after valve and combined valve and coronary procedures. The impact of preoperative renal dysfunction on patient outcome was investigated. Methods: This was a retrospective observational study of 916 patients who underwent solitary valve or combined procedures. Primary outcome was in-hospital mortality. Preoperative estimated glomerular filtration rate (eGFR) was calculated with the abbreviated Modification of Diet in Renal Disease formula. Results: Independent predictors of death were prolonged stay in the intensive care unit (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01 to 1.05), preoperative atrial fibrillation (OR, 1.61; 95% CI, 1.02 to 2.54), chronic obstructive pulmonary disease (OR, 2.2; 95% CI, 1.06 to 4.55), and prolonged operation time (OR, 1.01; 95% CI, 1.00 to 1.01). Each unit of the eGFR (mL/min/1.73m2) above average exerted a renoprotective effect (OR, 0.97; 95% CI, 0.96 to 0.98). The final regression model showed no lack of fit (Hosmer-Lemeshow test, p = 0.38) and a good discrimination performance in a receiver operating characteristic analysis (area under the curve, 0.84; 95% CI, 0.80 to 0.88). The lower the preoperative eGFR rate, the longer the postoperative stay at the intensive care unit. Conclusions: Renal dysfunction is an important independent predictor of in-hospital mortality in adult patients after valve and combined valve and coronary procedures. [Copyright &y& Elsevier]

Abstract: Introduction: Measures of heart rate variability (HRV) can be divided in time domain and frequency domain parameters. It is frequently ignored that estimation of frequency-domain parameters is a 2-step procedure where statistical error from the first step (spectral estimation) is neglected in subsequent analyses. Methods: We performed a simulation study to quantify the statistical error by using frequency domain instead of time domain parameters. We generated tachograms from a stationary AR(1) process for a wide range of parameters and compared the resulting estimation error (in terms of precision and variability) for the standard deviation of normal RR intervals (SDNN) and low frequency (LF), high frequency (HF), and LF/HF power. Results: Estimation of frequency domain parameters is associated with (up to 10-fold) increased variability, as compared with the SDNN. Moreover, the SDNN has higher precision. Conclusion: Frequency domain parameters should be applied in HRV analysis only if important physiological reasons suggest their use. If used, frequency domain parameters should be interpreted with caution, taking into account the statistical weaknesses of spectral estimation. [Copyright &y& Elsevier]

Background. Vasoconstriction after lung transplantation is a well-known phenomenon, but only limited information is available on blood flow distribution after ischemia and reperfusion. The aim of our study was to determine the regional flow characteristics in transplanted and native dog lungs after 24 hours of cold storage and preservation with Euro Collins-solution.Methods. Six pairs of weight-matched Foxhounds (25 to 30 kg) were used. In donors and recipients, aortic and pulmonary artery catheters were inserted percutaneously and a reference withdrawal catheter was placed into the main pulmonary artery. For preservation, the lungs were perfused with modified Euro Collins-solution and stored at 4°C. After 24 hours, the left lung was transplanted. Regional pulmonary blood flow was assessed by injection of colored microspheres into the right atrium using the reference withdrawal technique. Measurements of regional pulmonary blood flow were conducted twice in donors and recipients (baseline and 3 hours after reperfusion). Tissue samples from five distinct regions (apical, medial, dorsal, ventral, and lateral) were taken to assess regional pulmonary blood flow and wet–dry ratios.Results. The relative (‰ Confidence Intervals/100 mg dry weight) regional pulmonary blood flow was significantly reduced in the transplanted lung but not in the native organ. This reduction was most pronounced in apical regions and smallest in regions close to the hilum. Edema formation occurred in both lungs, as judged from wet-to-dry ratios of lung tissue specimen.Conclusions. Two separate processes can be observed after single lung transplantation: (1) reduced regional pulmonary blood flow, which is a regional phenomenon restricted to the transplanted organ, and (2) extensive edema affecting both the transplanted and the native lung. [Copyright &y& Elsevier]

Objective: To analyze the interrelationship of metabolic control, age- and sex-adjusted body mass index, and daily insulin dose and to identify heterogeneous multivariate developmental curves from childhood to young adulthood in a large cohort of children with type 1 diabetes (T1D) STUDY DESIGN: Data were extracted from the diabetes follow-up registry DPV. Longitudinal data from 9239 participants with T1D age 8-18 years with diabetes duration ≥2 years and ≥5 years of follow-up were analyzed. We applied group-based multitrajectory modeling to identify latent groups of subjects following similar developmental curves across outcomes (hemoglobin A1c [HbA1c], age/sex-standardized body mass index [BMI-SDS], daily insulin dose per kg). Group number was based on Bayes information criterion and group size (≥5%).Results: The group-based multitrajectory approach revealed 5 heterogeneous 3-variate trajectories during puberty. Individuals with stable good metabolic control, high-normal increasing BMI-SDS, and rising insulin dose patterns were classified as group 1 (33%). Group 2 (20%) comprised youths with intermediate-increasing HbA1c, low BMI-SDS, and steeply increasing insulin dose trajectories. Group 3 (11%) followed intermediate-rising HbA1c and high-normal increasing BMI-SDS developmental curves, while insulin dose increased steeply. In group 4 (14%), both high-increasing HbA1c and insulin dose trajectories were observed, while BMI-SDS was stable-normal. Group 5 (22%) included subjects with intermediate-rising HbA1c patterns, high-increasing BMI-SDS, and increasing insulin dose patterns.Conclusions: This study identified 5 distinct 3-variate curves of HbA1c, BMI-SDS, and insulin dose during puberty among youths with T1D. This approach demonstrates a considerable heterogeneity highlighting the importance of personalized medical care. [ABSTRACT FROM AUTHOR]

The author discusses several reports of statistics related to outpatient hysterectomies and the total hysterectomy rates in Germany and mentions the negative consequences of bilateral ovariectomy. He mentions the increased cases of unnecessary hysterectomy surgery of woman suffering from asymptomatic uterine fibroids. He also discusses the reports which criticizes such facts and mentions that the hysterectomy rates are correctly reported.

Objective: It is commonly believed that especially higher-risk patients benefit from off-pump coronary artery bypass grafting. However, analyses from several registries give different results. A common shortcoming of all those analyses is the fact that they concentrate on evidence from nonrandomized trials. Methods: In an ecologic analysis, we included all randomized trials comparing the on- and off-pump techniques until January 2011. By logistic regression, we investigated whether the effect of off-pump surgery on mortality, myocardial infarction, stroke, and atrial fibrillation is modified across the range of the 3 risk factors: age, proportion of women, and ejection fraction. Results: Eighty-six studies with a total population of 9906 patients reported on at least 1 risk factor and 1 outcome. We found a superiority of the off-pump technique in patients with lower ejection fraction values for the outcomes mortality and atrial fibrillation. No effect modification was seen for the risk factors age and proportion of women. Conclusions: Our ecologic analysis of nearly 10,000 patients from 86 randomized trials found a superiority of the off-pump technique in patients with lower ejection fraction values, especially for the most valid outcome of mortality. As every ecologic analysis is prone to ecologic bias, a definite answer on the benefit of the off-pump technique in higher-risk patients can only be given by meta-analyses using individual patient data. [ABSTRACT FROM AUTHOR]

The article offers information on the study conducted by the authors related to hysterectomy rates and different types of hysterectomy performed in Germany in 2005 and 2006. It states that rate of hysterectomy during these years was 362 per 100,000 persons and the most common type were abdominal and vaginal hysterectomy. It mentions that the highest number of vaginal hysterectomies was in surgeries for cancer of female genital organs.

Objective: Despite numerous randomized and nonrandomized trials on off- and on-pump coronary artery bypass grafting, it remains open which method is superior. Patient selection and small sample sizes limit the evidence from randomized trials; lack of randomization limits the evidence from nonrandomized trials. Propensity score analyses are expected to improve on at least some of these problems. We aimed to systematically review all propensity score analyses comparing off- and on-pump coronary artery bypass grafting. Methods: Propensity score analyses comparing off- and on-pump surgery were identified from 8 bibliographic databases, citation tracking, and a free web search. Two independent reviewers abstracted data on 11 binary short-term outcomes. Results: A total of 35 of 58 initially retrieved propensity score analyses were included, accounting for a total of 123,137 patients. The estimated overall odds ratio was less than 1 for all outcomes, favoring off-pump surgery. This benefit was statistically significant for mortality (odds ratio, 0.69; 95% confidence interval, 0.60–0.75), stroke, renal failure, red blood cell transfusion (P < .0001), wound infection (P < .001), prolonged ventilation (P < .01), inotropic support (P = .02), and intraaortic balloon pump support (P = .05). The odds ratios for myocardial infarction, atrial fibrillation, and reoperation for bleeding were not significant. Conclusions: Our systematic review and meta-analysis of propensity score analyses finds off-pump surgery superior to on-pump surgery in all of the assessed short-term outcomes. This advantage was statistically significant and clinically relevant for most outcomes, especially for mortality, the most valid criterion. These results agree with previous systematic reviews of randomized and nonrandomized trials. [ABSTRACT FROM AUTHOR]