Impact of the COVID-19 pandemic on delays in surgical procedures in Germany: a multi-center analysis of an administrative registry of 176,783 patients.

BACKGROUND: While extensive data are available on the postponement of elective surgical procedures due to the COVID-19 pandemic for Germany, data on the impact on emergency procedures is limited. METHODS: In this retrospective case-control study, anonymized case-related routine data of a Germany-wide voluntary hospital association (CLINOTEL association) of 66 hospitals was analyzed. Operation volumes, in-hospital mortality, and COVID-19 prevalence rates in digestive surgery procedure groups and selected single surgical procedures in the one-year periods before and after the outbreak of the COVID-19 pandemic were analyzed. The analysis was stratified by admitting department (direct admission or transfer to the general surgical department, i.e., primary or secondary surgical patients) and type of admission (elective/emergent). RESULTS: The total number of primary and secondary surgical patients decreased by 22.7% and 11.7%, respectively. Among primary surgical patients more pronounced reductions were observed in elective (-25.6%) than emergency cases (-18.8%). Most affected procedures were thyroidectomies (-30.2%), operations on the anus (-24.2%), and closure of abdominal hernias (-23.9%; all P's < 0.001). Declines were also observed in colorectal (-9.0%, P = 0.002), but not in rectal cancer surgery (-3.9%, n.s.). Mortality was slightly increased in primary (1.3 vs. 1.5%, P < 0.001), but not in secondary surgical cases. The one-year prevalence of COVID-19 in general surgical patients was low (0.6%), but a significant driver of mortality (OR = 9.63, P < 0.001). CONCLUSIONS: Compared to the previous year period, the number of patients in general and visceral surgery decreased by 22.7% in the first pandemic year. At the procedure level, a decrease of 14.8% was observed for elective procedures and 6.0% for emergency procedures. COVID-19 infections in general surgical patients are rare (0.6% prevalence), but associated with high mortality (21.8%). TRIAL REGISTRATION: The present study does not meet the ICMJE definition of a clinical trial and was therefore not registered.

[Role of Clinical, Sociomedical and Psychological Factors on Return to Work of Patients with Breast Cancer 6 Months after Rehabilitation]. / Einfluss klinischer, sozialmedizinischer und psychologischer Faktoren auf die berufliche Reintegration von Patientinnen mit Brustkrebs 6 Monate nach der Rehabilitation.

AIM OF THE STUDY: The majority of patients with non-metastatic breast cancer return to work after tumor therapy. A rate of up to 80% is given in national and international studies, which can vary considerably depending on the study population and the various social systems. However, it is unclear how many patients are reintegrated into work after medical rehabilitation and which clinical, sociodemographic and psychological factors play a role. METHODS: In a multicentre study, clinical and sociodemographic data were collected from breast cancer patients at the beginning of their medical rehabilitation. Subjectively experienced deficits in attention performance (FEDA), depressive symptoms (PHQ-9) and health-related quality of life (EORTC QLQ-C30) were recorded using standardized questionnaires. The cognitive performance was also examined using a computer-based test battery (NeuroCog FX). A follow-up survey was carried out 6-9 months after medical rehabilitation. The subjective assessment of one's own cognitive performance (FEDA) was recorded again at this time. RESULTS: 396 of the originally 476 patients were included in the study. In the follow-up survey, 323/396 patients (82%) were again employed. In a regression model, sociodemographic factors proved to be particularly predictive with regard to occupational reintegration: employment at the time of the tumor diagnosis, job preserved after medical rehabilitation, employee status and gradual reintegration according to the Hamburg model (Nagelkerke R2=0.685). This model could not be improved by adding psychological variables. The subjective patient information in all questionnaires was highly correlated (r>0.57; p<0.001). CONCLUSION: The vast majority of breast cancer patients return to work after medical rehabilitation. Socio-demographic factors play a crucial role in this. The regression model developed here, including the employment status, professional orientation and gradual reintegration, is of predictive importance and can be used in medical rehabilitation.

NeuroCog FX study: A multicenter cohort study on cognitive dysfunction in patients with early breast cancer.

OBJECTIVE: Complaints about cognitive dysfunction (CD) reportedly persist in approximately one third of breast cancer patients, but the nature of CD and possible risk factors are unknown. METHODS: A cross-sectional, multicenter study was set up at 9 German oncological rehabilitation centers. Objective cognitive performance was assessed by the NeuroCog FX test, a short computerized screening (duration <30 minutes) which assesses working memory, alertness, verbal/figural memory, and language/executive. Patients' test performance was correlated with treatment factors (chemo-, radiotherapy), subjective performance (FEDA), depression (PHQ-9), quality of life (EORTC QLQ-30), and clinical characteristics. RESULTS: From February 2013 to December 2014, a clinically homogenous sample of 476 patients was recruited (early tumor stage [T0-T2]: 93%; node-negative: 67%; chemotherapy: 61%; radiotherapy: 84%). NeuroCog FX could be administered in 439 patients (92%; median age: 50 [24-62] years). Patients showed decreased performance in attentional-executive functions (but not verbal/figural memory) and a 3-fold rate of CD in terms of below average performance in at least 1 cognitive domain (42%). Approximately 40% of the patients also reported subjective cognitive impairment (FEDA). No therapy-specific effect on test performance was obtained in the NeuroCog FX test. CONCLUSIONS: Breast cancer survivors showed objective attentional-executive and subjective cognitive impairments. No therapy-specific adverse side effect on objective cognitive performance was found. Depression strongly contributed to objective and subjective cognitive complaints and reduced quality of life.

[Factors affecting in-hospital mortality in patients with sepsis: Development of a risk-adjusted model based on administrative data from German hospitals]. / Einflussgrößen auf die Krankenhaussterblichkeit bei Patienten mit Sepsis ­ Entwicklung eines risikoadjustierten Modells auf Basis der Leistungsdaten deutscher Krankenhäuser.

BACKGROUND: Inpatient administrative data from hospitals is already used nationally and internationally in many areas of internal and public quality assurance in healthcare. For sepsis as the principal condition, only a few published approaches are available for Germany. The aim of this investigation is to identify factors influencing hospital mortality by employing appropriate analytical methods in order to improve the internal quality management of sepsis. METHODS: The analysis was based on data from 754,727 DRG cases of the CLINOTEL hospital network charged in 2015. The association then included 45 hospitals of all supply levels with the exception of university hospitals (range of beds: 100 to 1,172 per hospital). Cases of sepsis were identified via the ICD codes of their principal diagnosis. Multiple logistic regression analysis was used to determine the factors influencing in-hospital lethality for this population. The model was developed using sociodemographic and other potential variables that could be derived from the DRG data set, and taking into account current literature data. The model obtained was validated with inpatient administrative data of 2016 (51 hospitals, 850,776 DRG cases). RESULTS: Following the definition of the inclusion criteria, 5,608 cases of sepsis (2016: 6,384 cases) were identified in 2015. A total of 12 significant and, over both years, stable factors were identified, including age, severity of sepsis, reason for hospital admission and various comorbidities. The AUC value of the model, as a measure of predictability, is above 0.8 (H-L test p>0.05, R2 value=0.27), which is an excellent result. CONCLUSION: The CLINOTEL model of risk adjustment for in-hospital lethality can be used to determine the mortality probability of patients with sepsis as principal diagnosis with a very high degree of accuracy, taking into account the case mix. Further studies are needed to confirm whether the model presented here will prove its value in the internal quality assurance of hospitals.

A model for the determination of pollen count using google search queries for patients suffering from allergic rhinitis.

Background. The transregional increase in pollen-associated allergies and their diversity have been scientifically proven. However, patchy pollen count measurement in many regions is a worldwide problem with few exceptions. Methods. This paper used data gathered from pollen count stations in Germany, Google queries using relevant allergological/biological keywords, and patient data from three German study centres collected in a prospective, double-blind, randomised, placebo-controlled, multicentre immunotherapy study to analyse a possible correlation between these data pools. Results. Overall, correlations between the patient-based, combined symptom medication score and Google data were stronger than those with the regionally measured pollen count data. The correlation of the Google data was especially strong in the groups of severe allergy sufferers. The results of the three-centre analyses show moderate to strong correlations with the Google keywords (up to >0.8 cross-correlation coefficient, P < 0.001) in 10 out of 11 groups (three averaged patient cohorts and eight subgroups of severe allergy sufferers: high IgE class, high combined symptom medication score, and asthma). Conclusion. For countries with a good Internet infrastructure but no dense network of pollen traps, this could represent an alternative for determining pollen levels and, forecasting the pollen count for the next day.

Thermal water applications in the treatment of upper respiratory tract diseases: a systematic review and meta-analysis.

Background. Thermal water inhalations and irrigations have a long tradition in the treatment of airway diseases. Currently there exists no systematic review or meta-analysis on the effectiveness of thermal water treatment in upper respiratory tract diseases. Methods. A systematic search in the databases of MEDLINE, EMBASE, CENTRAL, ISI Web of Science, and MedPilot was accomplished. Results. Eight evaluable outcome parameters from 13 prospective clinical studies were identified for 840 patients. Mucociliary clearance time improves significantly (P < 0.01) for the pooled thermal water subgroup and the sulphurous subgroup after 2 weeks (-6.69/minutes) and after 90 days (-8.33/minutes), not for isotonic sodium chloride solution (ISCS). Nasal resistance improved significantly after 2 weeks (Radon, ISCS, and placebo), after 30 days (sulphur and ISCS), and after 90 days (sulphur). Nasal flow improved significantly with the pooled thermal water, radon alone, and ISCS subgroups. For the IgE parameter only sulphurous thermal water (P < 0.01) and ISCS (P > 0.01) were analyzable. Adverse events of minor character were only reported for sulphurous treatment (19/370). Conclusion. Thermal water applications with radon or sulphur can be recommended as additional nonpharmacological treatment in upper airway diseases. Also in comparison to isotonic saline solution it shows significant improvements and should be investigated further.

Nucleoplasty, a minimally invasive procedure for disc decompression: a systematic review and meta-analysis of published clinical studies.

BACKGROUND: Nucleoplasty, based on Coblation® technology, is a minimally invasive procedure used to decompress herniated discs. Reviews to date--exclusively systematic reviews--recommend nucleoplasty for treating chronic back pain, although with the restriction of limited to fair evidence. We therefore aimed to summarize and interpret our calculated results, where possible comprehensively and quantitatively, using statistical methods in the context of a meta-analysis supplementing a systematic review. In the process, the central question was to statistically determine whether, and to what extent, nucleoplasty can positively affect pain relief and functional mobility as well as lower the complication rate. OBJECTIVE: Newly published studies made it possible to conduct a meta-analysis of the visual analog scale (VAS), a measuring instrument used to determine pain intensity, and the Oswestry Disability Index (ODI), a scale that reflects the degree of impairment in percent. In addition to having clearly sound evidence for analyzing VAS/NPS data, the present, newly compiled meta-analysis was able to summarize VAS and ODI data quantitatively and to calculate a total complication rate for the first time. It was thereby possible to make a first comparison between nucleoplasty and conservative therapy (including epidural steroid injection). STUDY DESIGN: This meta-analysis examined all study data published in clinical trials involving the nucleoplasty procedure for plasma disc decompression. METHODS: A systematic search using the terms nucleoplasty and/or plasma disc decompression was conducted for literature listed in MEDLINE. Twenty-seven eligible studies (22 prospective trials and 5 retrospective trials) were included, and pooled analyses as well as various subgroup analyses (differentiation between cervical and lumbar disc herniations, comparisons with alternative treatments such as epidural steroid injection) were performed based on their data. RESULTS: Pain decreased from a baseline VAS value of 7.27 to 2.12 (postop/first day), 2.50 (one week), 2.70 (2 weeks), 3.23 (one month), 2.66 (6 weeks), 2.84 (3 months), 3.06 (6 months), 3.03 (12 months), 1.54 (18 months), and 3.69 (24 months) after nucleoplasty. The ODI value (baseline: 58.95) dropped to 28.60 (one week), 29.00 (2 weeks), 23.21 (one month), 30.00 (6 weeks), 18.30 (3 months), 22.54 (6 months), 24.43 (12 months), 12.82 (18 months), and 36.98 (24 months). Compared to baseline, significant pain reduction and improvement in functional mobility after nucleoplasty were observed at every time point. Nucleoplasty showed a total complication rate of 1.5%, with the individual rates being 0.8% for cervical and 1.8% for lumbar nucleoplasty. Nucleoplasty was superior to conservative therapy at every time point and for all 3 included parameters, at some measurement time points even significantly. CONCLUSIONS: Nucleoplasty reduces pain in the long term and improves patients' functional mobility. It is an effective, low-complication, minimally invasive procedure used to treat disc herniations.

The effectiveness of modern antihistamines for treatment of allergic rhinitis - an IPD meta-analysis of 140,853 patients.

BACKGROUND: Allergic rhinitis represents a worldwide health problem. The prevalence is increasing. The aim of this study was to analyse the correlation between the severity of allergic rhinitis and an adequate treatment dose of modern oral antihistamines. METHODS: From a comprehensive databank containing data from ten different open-label prospective observational studies including raw data of 140,853 patients with allergic rhinitis, symptomatology variables were analysed and scored to study the effects of treatment with four antihistamines (Desloratadine, Ebastine, Fexofenadine, Levocetirizine) alone or in combination with intranasal corticosteroids. The patient data were collected in 23,606 study centres from Germany, mostly medical specialist and some primary care physicians in private practice. The analyses were performed via individual patient data meta-analysis techniques. RESULTS: Finally 92,900 patient data from nine of ten studies could be analysed. One study with data of 47,953 patients was excluded due to incomplete treatment documentation. Both monotherapy analysis subgroups (Total Symptom Score and Total Nasal Symptom Score) were significantly better than those of their combinations with intranasal steroids. Monotherapy with levocetirizine was determined to be significantly more effective in lowering the Total Symptom Score (p < 0.001) and the Total Nasal Symptom Score (p < 0.05) than the other antihistamines. In the next stage, a greater positive effect of levocetirizine was demonstrated in relation to the severity of the clinical symptoms of allergic rhinitis (Total Nasal Symptom Score in cases with severe symptomatology [effect size = -0.09]). CONCLUSIONS: Levocetirizine asserted itself as the only antihistamine compared with the others as significant in this analysis. The study authors recommend monotherapy with the new-generation antihistamine levocetirizine, especially in severe cases of allergic rhinitis.

Reintegrating cancer patients into the workplace.

BACKGROUND: In Germany at present, 64% of women and 59% of men who receive a diagnosis of cancer are still alive five years later. 45% of men and 57% of women with cancer are still of working age. Cancer can markedly harm their ability to work. METHODS: We analyzed data from selected publications to calculate the percentage of cancer patients in Germany who are now returning to work. RESULTS: The efficacy of oncological rehabilitation has not been demonstrated by a randomized controlled trial, nor is it clear whether the existing studies have accounted for potentially confounding variables. A combined assessment of reports from various countries reveals that 63% of cancer patients who are of working age go back to work after being unable to work for an average of five months. The situation varies markedly across countries: In Germany, the percentage of women with breast cancer who return to work is only 59%, compared to 80% in the USA and 82% in the United Kingdom. Younger and better educated patients are more likely to return to work, as are those who have received less invasive treatment with fewer complications. CONCLUSION: Most cancer patients of working age go back to work, but the percentages vary widely from one country to another, perhaps reflecting differences in social systems.

The effectiveness of levocetirizine in comparison with loratadine in treatment of allergic rhinitis--a meta-analysis.

BACKGROUND: Oral antihistamines are considered the gold standard therapy for allergic rhinitis to date. The goal of this investigation is to make an indirect comparison between loratadine, an oral antihistamine available over-the-counter (OTC) in the USA, and the more modern antihistamine levocetirizine. Only double-blind, placebo-controlled (DBPC) studies involving monotherapy with the active substances levocetirizine and loratadine were included in the meta-analysis. METHODS: The medical databases EMBASE and Medline were searched systematically for all relevant studies completed by the end of 2009. Only DBPC studies conducted in normal environmental settings were included. Furthermore, the Jadad scale was used to guarantee the quality of the studies involved. The "standardized mean difference" (SMD) method was applied for calculating the study-specific effects to neutralize the variability between studies. RESULTS: The results of a total of seven published DBPC studies met all criteria for inclusion in meta-analysis. The meta-analysis showed that levocetirizine was significantly more effective than loratadine in improving the total symptom score (TSS) (p < 0.01). The effect sizes were calculated as -0.59 (95% confidence interval -0.89, -0.29) for levocetirizine and -0.21 (95% confidence interval -0.31, -0.1) for loratadine when compared to placebo. CONCLUSIONS: The results of this meta-analysis illustrate greater effectiveness for treatment with the active substance levocetirizine as monotherapy in reducing allergic symptoms when compared to treatment with loratadine.

Changes in bone density and metabolism in pregnancy.

OBJECTIVE: The impact of pregnancy on maternal bone density remains unclear. As a prerequisite to investigate the pathophysiology of gestational bone metabolism, we sought to document the changes in bone metabolism biochemistry in conjunction with those in selective trabecular/cortical osteodensitometry between early and late pregnancy. METHODS: A prospective, controlled study in a university hospital was conducted with 43 healthy women, 34 of them during uneventful pregnancy. The main outcome measures are trabecular and cortical bone density measured in the first and third trimesters using peripheral quantitative computed tomography in conjunction with a panel of bone metabolism parameters, including blood parathyroid hormone, calcitonin, osteocalcin, skeletal alkaline phosphatase, and the urinary desoxypyridinoline/creatinine ratio. RESULTS: Cortical bone density was unaffected by pregnancy. Trabecular bone density changes showed wide interindividual variation, ranging from +1.3 to -20.7% per year, identified as fast losers (less than -3%) and slow losers (more than -3%). Serum osteocalcin levels were lower in slow versus fast bone losers in both trimesters (first: P=0.02, third: P=0.02) and were the only independent parameter to differentiate between fast and slow losers. CONCLUSIONS: Our data suggest that wide interindividual variation and the failure to provide a separate measure of trabecular bone density account for the conflicting evidence in earlier reports. Serum osteocalcin concentration during the first trimester distinguishes between fast and slow losers of trabecular bone and should be evaluated in future studies as predictor for later bone loss (osteoporosis).

Original report. Fetal cardiographic monitoring during 1.5-T MR imaging.

OBJECTIVE: The aim of this report was to determine the feasibility of fetal cardiotocography during MR imaging and the safety of 1.5-T MR imaging on the basis of fetal heart activity and fetal movements. CONCLUSION: Fetal cardiotocography is feasible during MR imaging using modified standard equipment. The use of 1.5-T MR imaging appears to be safe and to have no negative short-term effects on the heart rate or movement incidence of healthy third-trimester fetuses under our experimental conditions.

How well does reflectance pulse oximetry reflect intrapartum fetal acidosis?

OBJECTIVE: The purpose of this study was to determine the sensitivity and specificity for acidosis of intrapartum fetal oxygen saturation measured by reflectance pulse oximetry. STUDY DESIGN: Intrapartum fetal oxygen saturation values per labor stage were correlated with umbilical artery pH, base excess and PCO(2) by regression analysis. Receiver operating characteristic curve analysis was performed with the use of historic umbilical arterial cutoff values; a fetal oxygen saturation cutoff range with optimal sensitivity and specificity was calculated. RESULTS: Mean fetal oxygen saturation was 42.8%, over the mean 132 minutes of 107 recordings. Overall areas under the sensitivity and specificity curves were 0.77 for pH and PCO(2), decreasing sharply toward birth; all areas for base excess were poor (approximately 0.5). Depending on stage and umbilical artery parameter, fetal oxygen saturation cutoffs were 33% to 36%, with sensitivities of 0.67 to 0.8 and specificities of 0.62 to 0.90. CONCLUSION: Fetal oxygen saturation sensitivities and specificities for acidosis do not yet justify the supplementation of cardiotocography with routine reflectance pulse oximetry.