Quantification of cervical spinal stenosis by automated 3D MRI segmentation of spinal cord and cerebrospinal fluid space.

DESIGN: Prospective diagnostic study. OBJECTIVES: Anatomical evaluation and graduation of the severity of spinal stenosis is essential in degenerative cervical spine disease. In clinical practice, this is subjectively categorized on cervical MRI lacking an objective and reliable classification. We implemented a fully-automated quantification of spinal canal compromise through 3D T2-weighted MRI segmentation. SETTING: Medical Center - University of Freiburg, Germany. METHODS: Evaluation of 202 participants receiving 3D T2-weighted MRI of the cervical spine. Segments C2/3 to C6/7 were analyzed for spinal cord and cerebrospinal fluid space volume through a fully-automated segmentation based on a trained deep convolutional neural network. Spinal canal narrowing was characterized by relative values, across sever segments as adapted Maximal Canal Compromise (aMCC), and within the index segment as adapted Spinal Cord Occupation Ratio (aSCOR). Additionally, all segments were subjectively categorized by three observers as "no", "relative" or "absolute" stenosis. Computed scores were applied on the subjective categorization. RESULTS: 798 (79.0%) segments were subjectively categorized as "no" stenosis, 85 (8.4%) as "relative" stenosis, and 127 (12.6%) as "absolute" stenosis. The calculated scores revealed significant differences between each category (p ≤ 0.001). Youden's Index analysis of ROC curves revealed optimal cut-offs to distinguish between "no" and "relative" stenosis for aMCC = 1.18 and aSCOR = 36.9%, and between "relative" and "absolute" stenosis for aMCC = 1.54 and aSCOR = 49.3%. CONCLUSION: The presented fully-automated segmentation algorithm provides high diagnostic accuracy and objective classification of cervical spinal stenosis. The calculated cut-offs can be used for convenient radiological quantification of the severity of spinal canal compromise in clinical routine.

Post-COVID in women after SARS-CoV-2 infection during pregnancy - a pilot study with follow-up data from the COVID-19-related Obstetric and Neonatal Outcome Study (CRONOS).

BACKGROUND: Pregnant women are at an increased risk of severe COVID-19 and adverse pregnancy outcomes; data on maternal long-term outcome is scarce. We analyzed long-term follow-ups on women who experienced a SARS-CoV-2 infection during pregnancy to evaluate post-COVID symptoms, particularly fatigue, and their association with quality of life (QoL). METHODS: 773 women who enrolled in the CRONOS registry between April 2020 and August 2021 were contacted for follow-up from December 2022 to April 2023. Data was gathered through a web-based questionnaire. Subsequently, study coordinators matched the follow-up data with the existing CRONOS data. RESULTS: 110/773 (14%) women provided data. 20.9% experienced only acute symptoms during their SARS-CoV-2 infection in pregnancy, while 2.7% women experienced symptoms lasting longer than 4 weeks (long COVID). Symptoms lasting longer than 12 weeks (post-COVID) were reported by 63.6% women and occurred more often after severe COVID-19. Fatigue was the most frequently reported symptom (88%), with 55% of women still experiencing it more than one year after initial infection. 76% of women rated their QoL as "good" or "very good". Women experiencing post-COVID reported a significantly lower QoL. CONCLUSION: This is the first German long-term data on women after SARS-CoV-2 infection during pregnancy, showing a high rate of post-COVID, a persistence of fatigue, and the impact on QoL. Continuous monitoring of pregnant women with COVID-19 is needed to develop comprehensive management strategies.

Automated signal intensity analysis of the spinal cord for detection of degenerative cervical myelopathy - a matched-pair MRI study.

PURPOSE: Detection of T2 hyperintensities in suspected degenerative cervical myelopathy (DCM) is done subjectively in clinical practice. To gain objective quantification for dedicated treatment, signal intensity analysis of the spinal cord is purposeful. We investigated fully automated quantification of the T2 signal intensity (T2-SI) of the spinal cord using a high-resolution MRI segmentation. METHODS: Matched-pair analysis of prospective acquired cervical 3D T2-weighted sequences of 114 symptomatic patients and 88 healthy volunteers. Cervical spinal cord was segmented automatically through a trained convolutional neuronal network with subsequent T2-SI registration slice-by-slice. Received T2-SI curves were subdivided for each cervical level from C2 to C7. Additionally, all levels were subjectively classified concerning a present T2 hyperintensity. For T2-positive levels, corresponding T2-SI curves were compared to curves of age-matched volunteers at the identical level. RESULTS: Forty-nine patients showed subjective T2 hyperintensities at any level. The corresponding T2-SI curves showed higher signal variabilities reflected by standard deviation (18.51 vs. 7.47 a.u.; p < 0.001) and range (56.09 vs. 24.34 a.u.; p < 0.001) compared to matched controls. Percentage of the range from the mean absolute T2-SI per cervical level, introduced as "T2 myelopathy index" (T2-MI), was correspondingly significantly higher in T2-positive segments (23.99% vs. 10.85%; p < 0.001). ROC analysis indicated excellent differentiation for all three parameters (AUC 0.865-0.920). CONCLUSION: This fully automated T2-SI quantification of the spinal cord revealed significantly increased signal variability for DCM patients compared to healthy volunteers. This innovative procedure and the applied parameters showed sufficient diagnostic accuracy, potentially diagnosing radiological DCM more objective to optimize treatment recommendation. TRIAL REGISTRATION: DRKS00012962 (17.01.2018) and DRKS00017351 (28.05.2019).

Reducing preventable adverse events in obstetrics by improving interprofessional communication skills - Results of an intervention study.

BACKGROUND: Progress in medicine involves the structured analysis and communication of errors. Comparability between the individual disciplines is only possible to a limited extent and obstetrics plays a special role: the expectation of a self-determined and joyful event meets with possibly serious complications in highly complex care situations. This must be managed by an interdisciplinary team with an increasingly condensed workload. Adverse events cannot be completely controlled. However, taking controllable risk factors into account and with a focused communication a reduction of preventable adverse events is possible. In the present study, the effect of interprofessional team training on preventable adverse events in an obstetric department was investigated. METHODS: The training consisted of a 4-h interdisciplinary training session based on psychological theories. Preventable adverse events were defined in six categories according to potential patterns of causation. 2,865 case records of a refence year (2018) and 2,846 case records of the year after the intervention (2020) were retrospectively evaluated. To determine the communication training effect, the identified preventable adverse events of 2018 and 2020 were compared according to categories and analyzed for obstetrically relevant controllable and uncontrollable risk factors. Questionnaires were used to identify improvements in self-reported perceptions and behaviors. RESULTS: The results show that preventable adverse events in obstetrics were significantly reduced after the intervention compared to the reference year before the intervention (13.35% in the year 2018 vs. 8.83% in 2020, p < 0.005). Moreover, obstetrically controllable risk factors show a significant reduction in the year after the communication training. The questionnaires revealed an increase in perceived patient safety (t(28) = 4.09, p < .001), perceived communication behavior (t(30) = -2.95, p = .006), and self-efficacy to cope with difficult situations (t(28) = -2.64, p = .013). CONCLUSIONS: This study shows that the communication training was able to reduce preventable adverse events and thus increase patient safety. In the future, regular trainings should be implemented alongside medical emergency trainings in obstetrics to improve patient safety. Additionally, this leads to the strengthening of human factors and ultimately also to the prevention of second victims. Further research should follow up implementing active control groups and a randomized-controlled trail study design. TRIAL REGISTRATION: The study was approved by the Ethics Committee of University Hospital (protocol code 114/19-FSt/Sta, date of approval 29 May 2019), study registration: NCT03855735 .

Diagnosis and treatment of meralgia paresthetica between 2005 and 2018: a national cohort study.

The prevalence of meralgia paresthetica (MP), which is caused by compression of the lateral femoral cutaneous nerve (LFCN), has been increasing over recent decades. Since guidelines and large-scale studies are lacking, there are substantial regional differences in diagnostics and management in MP care. Our study aims to report on current diagnostic and therapeutic strategies as well as time trends in clinical MP management in Germany. Patients hospitalized in Germany between January 1, 2005, and December 31, 2018, with MP as their primary diagnosis were identified using the International Classification of Disease (ICD-10) code G57.1 and standardized operations and procedures codes (OPS). A total of 5828 patients with MP were included. The rate of imaging studies increased from 44% in 2005 to 79% in 2018 (p < 0.001) and that of non-imaging diagnostic studies from 70 to 93% (p < 0.001). Among non-imaging diagnostics, the rates of evoked potentials and neurography increased from 20%/16% in 2005 to 36%/23% in 2018 (p < 0.001, respectively). Rates of surgical procedures for MP decreased from 53 to 37% (p < 0.001), while rates of non-surgical procedures increased from 23 to 30% (p < 0.001). The most frequent surgical interventions were decompressive procedures at a mean annual rate of 29% (± 5) throughout the study period, compared to a mean annual rate of 5% (± 2) for nerve transection procedures. Between 2005 and 2018, in-hospital MP care in Germany underwent significant changes. The rates of imaging, evoked potentials, neurography, and non-surgical management increased. The decompression of the LFCN was substantially more frequent than that of the LFCN transection, yet both types of intervention showed a substantial decrease in in-hospital prevalence over time.

Diffusion tensor imaging in unclear intramedullary tumor-suspected lesions allows separating tumors from inflammation.

DESIGN: Prospective diagnostic study. OBJECTIVES: Primary imaging-based diagnosis of spinal cord tumor-suspected lesions is often challenging. The identification of the definite entity is crucial for dedicated treatment and therefore reduction of morbidity. The aim of this trial was to investigate specific quantitative signal patterns to differentiate unclear intramedullary tumor-suspected lesions based on diffusion tensor imaging (DTI). SETTING: Medical Center - University of Freiburg, Germany. METHODS: Forty patients with an unclear tumor-suspected lesion of the spinal cord prospectively underwent DTI. Primary diagnosis was determined by histological or clinical work-up or remained indeterminate with follow-up. DTI metrics (FA/ADC) were evaluated at the central lesion area, lesion margin, edema, and normal spinal cord and compared between different diagnostic groups (ependymomas, other spinal cord tumors, inflammations). RESULTS: Mean DTI metrics for all spinal cord tumors (n = 18) showed significantly reduced FA and increased ADC values compared to inflammatory lesions (n = 8) at the lesion margin (p < 0.001, p = 0.001) and reduced FA at the central lesion area (p < 0.001). There were no significant differences comparing the neoplastic subgroups of ependymomas (n = 10) and other spinal cord tumors (n = 8), but remaining differences for both compared to the inflammation subgroup. We found significant higher ADC (p = 0.040) and a trend to decreased FA (p = 0.081) for ependymomas compared to inflammations at the edema. CONCLUSION: Even if distinct differentiation of ependymomas from other spinal cord neoplasms was not possible based on quantitative DTI metrics, FA and ADC were feasible to separate inflammatory lesions. This may avoid unnecessary surgery in patients with unclear intramedullary tumor-suspected lesions.

The challenge of measuring spinopelvic parameters: inter-rater reliability before and after minimally invasive lumbar spondylodesis.

BACKGROUND: The common manual measurement technique of spinal sagittal alignment on X-rays is susceptible to rater-dependent variability, which has not been adequately considered in previous publications. This study investigates the effect of those variations in the characterization of patients receiving lumbar spondylodesis. METHODS: General alignment parameters on pre- and postoperative X-rays were evaluated by four raters in 43 prospectively sampled patients undergoing monolevel spondylodesis. The Intra-class Correlation Coefficient (ICC) for each rater pair and all raters together was calculated for inter-rater reliability. For the operation-induced change of the sagittal alignment in every patient the Wilcoxon test was applied to compare for each rater separately. RESULTS: The ICCs were "good" (>0.75) to "excellent" (>0.9) for all raters together and for 45 of the 48 single rater pairs (93.75%). All revealed a significant increase of the addressed segmental lordosis and disc height and no significant change for spinopelvic parameters and sagittal vertical axis from pre- to postoperative. The lumbar lordosis showed a significant increase through the operation of +2.5° (p = 0.014) and +3.7° (p = 0.015) in two raters and no difference for the other ones (+2.1°, p = 0.171; -2.2°, p = 0.522). CONCLUSIONS: The pre- to postoperative change of lumbar lordosis revealed different significance levels for different raters, although the ICCs were formally good. Accordingly, the evaluation by only one rater would lead to different conclusions. Due to this susceptibility of alignment measurements to rater-dependent variability, the exact evaluation process should be described in every publication and the consistency of significant results be validated through multiple raters. TRIALS REGISTRATION: The trial was approved by the local ethics committee and listed at the national clinical trials register ( DRKS00004514 , date of registration: 08/11/2012).

Cranial facet joint injuries in percutaneous lumbar pedicle screw placement: a matched-pair analysis comparing intraoperative 3D navigation and conventional fluoroscopy.

PURPOSE: The violation of the cranial adjacent facet is a frequent complication in lumbar instrumentations and can induce local pain and adjacent segment disease. Minimally invasive screw implantation is often stated as risk factor in comparison with open approaches. Percutaneous pedicle screw placement (PPSP) can be performed using single X-ray images (fluoroscopy) or intraoperative 3D navigation. The study compares top-level screws in percutaneous lumbar instrumentations regarding facet violations and screw pedicle position using navigation or fluoroscopy. METHODS: Patients after lumbar PPSP were retrospectively separated according to the intraoperative technique: navigation (NAV) or fluoroscopy (FLUORO). Two blinded investigators graded the top-level screws regarding facet violations and pedicle breach in postoperative CT scans. Subsequent matched cohort analysis was performed for comparable groups. RESULTS: Evaluating 768 screws, we assessed 70 (9.1%) facet violations. Overall, 186 (24.2%) screws were implanted using navigation. There was no significant difference in the rate of facet violations between both imaging groups (NAV 19/186, 10.2%, FLUORO 51/582, 8.8%, p = 0.55). Totally, 728 (94.8%) of all screws showed a correct pedicle position. Most of the 40 unfavorable pedicle positions were placed by fluoroscopy (NAV 4/186, 2.2%, FLUORO 36/582, 6.6%, p = 0.03). The matched cohorts verified these results (facet violations: NAV 19/186, 10.2%, FLUORO 18/186, 9.7%, p = 0.55; pedicle penetrations: NAV 4/186, 2.2%, FLUORO 12/186, 6.9%, p = 0.04). CONCLUSIONS: Both intraoperative imaging techniques allow lumbar PPSP with low rates of cranial facet violations if the surgeon intends to preserve facet integrity. Navigation was superior concerning accurate pedicle screw position, but could not significantly prevent facet violations.

Autologous platelet-rich fibrin (PRF) augmentation as an add-on therapy in deep surgical site infections (dSSIs) after instrumented spinal surgery: preliminary results of a single institution case series.

BACKGROUND: Deep surgical site infections (dSSIs) after instrumented spinal surgery pose major therapeutic challenges. Standard treatment involves surgical debridement, wound drainage, and long-term antibiotic administration. Autologous platelet-rich fibrin (PRF) constitutes a biomaterial obtained from patients' own blood that contains leukocytes, chemokines and growth factors boosting cicatrization. Due to favorable results reported from other surgical disciplines such as dentistry, orthopedics, maxillofacial and plastic surgery using PRF, the authors hypothesized that PRF augmentation will promote wound healing in dSSIs. OBJECTIVE: To report our preliminary results on the safety and efficacy of autologous-PRF as an add-on therapy on a pilot case series of persistent dSSI after instrumented spinal surgery. METHODS: Among the 293 patients who underwent dorsal decompression and stabilization of the cervical, thoracic, and lumbar spine due to degenerative diseases in our department, 12 patients (4%) presented persisting dSSI after standard wound debridement and antibiotic treatment. PRF augmentation was used during a second surgical revision as an add-on therapy to standard debridement. In all cases, the wound was primarily closed without drains. RESULTS: Wound healing was completed between 14 and 21 days after the second surgical revision in all patients. At a median follow-up of 8 months (range: 6 to 18 months), no recurrence of dSSI nor complications were encountered in any case. CONCLUSIONS: Our preliminary results suggest that PRF augmentation in persistent dSSI after instrumented spinal surgery appears to be a safe and effective strategy to promote wound healing. Prospective controlled studies are required to define the efficiency of PRF more clearly in both treating and preventing dSSI.

Radiation exposure of a mobile 3D C-arm with large flat-panel detector for intraoperative imaging and navigation - an experimental study using an anthropomorphic Alderson phantom.

BACKGROUND: Intraoperative 3-dimensional (3D) navigation is increasingly being used for pedicle screw placement. For this purpose, dedicated mobile 3D C-arms are capable of providing intraoperative fluoroscopy-based 3D image data sets. Modern 3D C-arms have a large field of view, which suggests a higher radiation exposure. In this experimental study we therefore investigate the radiation exposure of a new mobile 3D C-arm with large flat-panel detector to a previously reported device with regular flat-panel detector on an Alderson phantom. METHODS: We measured the radiation exposure of the Vision RFD 3D (large 30 × 30 cm detector) while creating 3D image sets as well as standard fluoroscopic images of the cervical and lumbar spine using an Alderson phantom. The dosemeter readings were then compared with the radiation exposure of the previous model Vision FD Vario 3D (smaller 20 × 20 cm detector), which had been examined identically in advance and published elsewhere. RESULTS: The larger 3D C-arm induced lower radiation exposures at all dosemeter sites in cervical 3D scans as well as at the sites of eye lenses and thyroid gland in lumbar 3D scans. At ​​male and especially female gonads in lumbar 3D scans, however, the larger 3D C-arm showed higher radiation exposures compared with the smaller 3D C-arm. In lumbar fluoroscopic images, the dosemeters near/in the radiation field measured a higher radiation exposure using the larger 3D C-arm. CONCLUSIONS: The larger 3D C-arm offers the possibility to reduce radiation exposures for specific applications despite its larger flat-panel detector with a larger field of view. However, due to the considerably higher radiation exposure of the larger 3D C-arm during lumbar 3D scans, the smaller 3D C-arm is to be recommended for short-distance instrumentations (mono- and bilevel) from a radiation protection point of view. The larger 3D C-arm with its enlarged 3D image set might be used for long instrumentations of the lumbar spine. From a radiation protection perspective, the use of the respective 3D C-arm should be based on the presented data and the respective application.

Communication and patient safety in gynecology and obstetrics - study protocol of an intervention study.

BACKGROUND: Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction. METHODS: The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes). DISCUSSION: This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users' motivation. Insights gained from this study can inform other patient safety interventions and health policy developments. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019.

Emergency peripartal hysterectomy - a single-center analysis of the last 13 years at a tertiary perinatal care unit.

Background Peripartal hysterectomy (PH) is a challenging surgical procedure with elevated maternal morbidity. Methods From 2004 to 2016, 41 emergency PHs were performed at the tertiary care center of the Department of Gynecology and Obstetrics at University Hospital Ulm. In our retrospective analysis, the incidence of PH in our hospital was 12.8 per 10,000 deliveries with a maternal mortality of 2.4%. PH followed in 80.5% after cesarean section (c-section). Underlying causes/indications for PH were abnormal placentation (53.7%; n=22), uterine atony (26.8%; n=11), uterine lacerations (14.6%; n=6) and in rare cases uterine infection (4.9%; n=2). The median number of transfused products was 11 packed red blood cells (range 0-55 products), 10 fresh frozen plasma units (range 1-43) and two platelet concentrates (0-16). Results Loss of blood as estimated by surgeons was significantly correlated with actual transfused blood volume (P<0.001). Clinically relevant intra- and/or postoperative complications occurred in 53.7% of patients (n=22). Abnormal placentation was the leading cause for PH with an increased incidence during the last 10 years presumptively representing the elevated rate of c-sections. Conclusion PH goes along with increased rates of blood product transfusions independently of indication for surgery and has a high morbidity with a major complication rate of more than 50%. Prepartal assessment of risk factors like abnormal invasive placenta are crucial for reducing maternal morbidity.

Prevalence of circulating tumor cells in early breast cancer patients 2 and 5 years after adjuvant treatment.

PURPOSE: Several studies have provided evidence on the prognostic relevance of circulating tumor cells (CTCs) detected before and after chemotherapy regarding overall survival (OS) and progression-free survival (PFS) in early breast cancer (EBC). We provide data on the prevalence of CTCs 2 and 5 years after primary diagnosis in a cohort of patients with EBC. METHODS: The SUCCESS study is a multicenter, prospective, randomized trial comparing PFS in primary breast cancer patients undergoing one of two adjuvant chemotherapy regimens followed by 2 versus 5 years of treatment with zoledronate. CTCs from patients without signs of breast cancer recurrence were analyzed in peripheral blood using the FDA cleared CellSearch® System (Veridex, USA) 2 and 5 years after primary diagnosis. RESULTS: CTCs were detected at 2 and 5 years after primary diagnosis in 96 (16.7%) and 47 (8.2%) of the 574 patients, respectively. There were no associations between CTC status and patient and tumor characteristics or treatment regimens. In 442 (77.0%) patients, no CTCs were detected at either of the two time points, and in 11 patients (1.9%), CTCs were found at both 2 and 5 years after primary diagnosis. In 85 (14.8%) patients, CTCs were present 2 years after primary diagnosis but not after 5 years, while 36 (6.3%) patients had CTCs in their blood only at the 5-year follow-up. CONCLUSIONS: In patients with EBC, CTCs can be detected even 5 years after primary diagnosis without clinical signs of disease recurrence.

Influence of Prognostic Factors on Lymph Node Involvement in Endometrial Cancer: A Single-Center Experience.

OBJECTIVE: The requirement for and extent of lymphadenectomy in endometrial cancer is still controversial. Clinicopathological prognostic factors could be helpful to predict lymph node involvement and avoid therefore unnecessary lymphadenectomy. The aim of this study was to investigate which factors can predict lymph node involvement and how lymph node metastases are distributed in the pelvic and para-aortic regions. METHODS: This retrospective analysis was performed by analyzing data from patients with endometrial cancer treated with standard surgery and lymphadenectomy at the Department of Gynecology and Obstetrics of the University Hospital Ulm in 2000 to 2013. RESULTS: One hundred twenty-five patients received pelvic lymphadenectomy with a median of 25 removed nodes, and 111 patients additionally received para-aortic lymphadenectomy with a median of 12 removed nodes. Metastatic lymph nodes were found in 24.8% of the patients, and a multivariate logistic regression showed that lymphovascular space invasion, histological type, and tumor stage significantly and independently predicted lymph node involvement. Of the 111 patients with both pelvic and para-aortic lymphadenectomy, 18 (16.2%) patients had metastatic para-aortic nodes, and 3 (2.7%) patients had isolated positive para-aortic lymph nodes without involvement of pelvic lymph nodes. DISCUSSION: Lymphovascular space invasion, histological type, and tumor stage are significant predictors of lymph node involvement in endometrial cancer. In patients at high risk of nodal involvement, lymphadenectomy should be performed systematically up to the renal vein. Large and carefully designed prospective studies are needed to evaluate patient cohorts for which a complete lymphadenectomy provides a survival benefit. In the future, the increasing use of sentinel node biopsy may facilitate a more personalized treatment of patients with endometrial cancer.

Evaluation of simparteam - a needs-orientated team training format for obstetrics and neonatology.

INTRODUCTION: A standardized team-training program for healthcare professionals in obstetric units was developed based on an analysis of common causes for adverse events found in claims registries. The interdisciplinary and inter-professional training concept included both technical and non-technical skill training. Evaluation of the program was carried out in hospitals with respect to the immediate personal learning of participants and also regarding changes in safety culture. METHODS: Trainings in n=7 hospitals including n=270 participants was evaluated using questionnaires. These were administered at four points in time to staff from participating obstetric units: (1) 10 days ahead of the training (n=308), (2) on training day before (n=239), (3) right after training (n=248), and (4) 6 months after (n=188) the intervention. Questionnaires included several questions for technical and non-technical skills and the Hospital Survey on Patient Safety (HSOPS). RESULTS: Strong effects were found in the participants' perception of their own competence regarding technical skills and handling of emergencies. Small effects could be observed in the scales of the HSOPS questionnaire. Most effects differed depending on professional groups and hospitals. CONCLUSIONS: Integrated technical and team management training can raise employees' confidence with complex emergency management skills and processes. Some indications for improvements on the patient safety culture level were detected. Furthermore, differences between professional groups and hospitals were found, indicating the need for more research on contributing factors for patient safety and for the success of crew resource management (CRM) trainings.

Detection of circulating tumor cells using manually performed immunocytochemistry (MICC) does not correlate with outcome in patients with early breast cancer - Results of the German SUCCESS-A- trial.

BACKGROUND: Recently, the prognostic significance of circulating tumor cells (CTCs) in primary breast cancer as assessed using the Food-and-Drug-Administration-approved CellSearch® system has been demonstrated. Here, we evaluated the prognostic relevance of CTCs, as determined using manually performed immunocytochemistry (MICC) in peripheral blood at primary diagnosis, in patients from the prospectively randomized multicenter SUCCESS-A trial (EudraCT2005000490-21). METHODS: We analyzed 23 ml of blood from 1221 patients with node-positive or high risk node-negative breast cancer before adjuvant taxane-based chemotherapy. Cells were separated using a density gradient followed by epithelial cell labeling with the anti-cytokeratin-antibody A45-B/B3, immunohistochemical staining with new fuchsin, and cytospin preparation. All cytospins were screened for CTCs, and the cutoff for positivity was at least one CTC. The prognostic value of CTCs with regard to disease-free survival (DFS), distant disease-free survival (DDFS), breast-cancer-specific survival (BCSS), and overall survival (OS) was assessed using both univariate analyses applying the Kaplan-Meier method and log-rank tests, and using multivariate Cox regressions adjusted for other predictive factors. RESULTS: In 20.6 % of all patients (n = 251) a median of 1 (range, 1-256) CTC was detected, while 79.4 % of the patients (n = 970) were negative for CTCs before adjuvant chemotherapy. A pT1 tumor was present in 40.0 % of patients, 4.8 % had G1 grading and 34.6 % were node-negative. There was no association between CTC positivity and tumor stage, nodal status, grading, histological type, hormone receptor status, Her2 status, menopausal status or treatment. Univariate survival analyses based on a median follow-up of 64 months revealed no significant differences between CTC-positive and CTC-negative patients with regard to DFS, DDFS, BCSS, or OS. This was confirmed by fully adjusted multivariate Cox regressions, showing that the presence of CTCs (yes/no) as assessed by MICC did not predict DFS, DDFS, BCSS or OS. CONCLUSIONS: We could not demonstrate prognostic relevance regarding CTCs that were quantified using the MICC method at the time of primary diagnosis in our cohort of early breast cancer patients. Further studies are necessary to evaluate if the presence of CTCs assessed using MICC has prognostic relevance, or can be used for risk stratification and treatment monitoring in adjuvant breast cancer. TRIAL REGISTRATION: The ClinicalTrial.gov registration ID of this prospectively randomized trial is NCT02181101 ; the (retrospective) registration date was June 2014 (study start date September 2005).

Giant central thoracic disc herniations: surgical outcome in 17 consecutive patients treated by mini-thoracotomy.

PURPOSE: Safe treatment of giant central thoracic disc herniations (cTDHs) remains a surgical challenge due to frequent calcifications, intradural extension and, importantly, the rare exposure of spine surgeons to these lesions. We report our 10-year experience in the management of giant cTDH by mini-thoracotomy and offer a detailed description of the technique. METHODS: 17 patients harboring 17 giant cTDH operated on via a mini-thoracotomy at the authors' institution between 2004 and 2014 were reviewed. All patients presented with myelopathy of varying magnitude. Mean patient age was 47 years. The mean follow-up period was 5.5 years. Median canal compromise of the cTDH was 66 %. cTDH were densely calcified in 7 (41 %), partially calcified in 6 (35 %) and soft in 4 (24 %) patients. Intradural extension of cTDH was noted in six patients (35 %). Benzels' modified myelopathy score of the Japanese Orthopedic Association was adjusted for the evaluation of thoracic myelopathy (mJOA) to assess functional outcomes. RESULTS: Successful removal of the offending cTDH was achieved in all patients. The overall mJOA Score improved from 7.9/13 to 11.1/13. Two patients with giant and densely calcified cTDH experienced a transient post-operative neurological decline. There was a statistically significant correlation between size of cTDH and intradural extension. CONCLUSION: Patients with myelopathy due to giant cTDH can be safely treated by the mini-thoracotomy approach. Postoperative neurological worsening and severe complications or incisional pain are rare. In contrast to complex posterior or thoracoscopic approaches, the mini-thoracotomy is technically straightforward and thus easy to learn for experienced spine surgeons.

Therapeutic intervention based on circulating tumor cell phenotype in metastatic breast cancer: concept of the DETECT study program.

PURPOSE: The aim of the ongoing DETECT study program is to evaluate therapeutic intervention based on phenotypes of circulating tumor cells (CTC) in patients with metastatic breast cancer (MBC). Currently (as of July 2015) more than half of the projected about 2000 patients with MBC have already been screened for CTC. METHODS: Women with HER2-negative primary tumor and presence of CTC are recruited into different DETECT trials according to the HER2-phenotype of CTC. Patients with HER2-positive CTC are randomized to treatment with physicians' choice therapy (standard chemo- or endocrine therapy) with or without additional HER2-targeted therapy with lapatinib in the DETECT III trial. In DETECT IVa, postmenopausal patients with hormone-receptor positive primary cancer and HER2-negative CTC receive everolimus and standard endocrine therapy. For women with HER2-negative CTC and triple negative MBC or hormone-receptor positive tumor and indication for chemotherapy, a treatment with eribulin is offered (DETECT IVb). The clinical efficacy is investigated by CTC-Clearance and progression-free survival (PFS). The DETECT V/CHEVENDO trial extends the DETECT study program for women with HER2-positive and hormone-receptor positive MBC. The primary objective of this trial is to compare safety and quality of life (QoL) as assessed by the occurrence of adverse events in patients treated with dual (trastuzumab plus pertuzumab) HER2-targeted therapy plus either endocrine or chemotherapy. The translational research projects of the DETECT study program focus on further molecular characterization of CTC and evaluation of markers for their suitability to predict treatment response and to facilitate the development of more personalized treatment options.

The influence of obesity on survival in early, high-risk breast cancer: results from the randomized SUCCESS A trial.

INTRODUCTION: Obese breast cancer patients have worse prognosis than normal weight patients, but the level at which obesity is prognostically unfavorable is unclear. METHODS: This retrospective analysis was performed using data from the SUCCESS A trial, in which 3754 patients with high-risk early breast cancer were randomized to anthracycline- and taxane-based chemotherapy with or without gemcitabine. Patients were classified as underweight/normal weight (body mass index (BMI) < 25.0), overweight (BMI 25.0-29.9), slightly obese (BMI 30.0-34.9), moderately obese (BMI 35.0-39.9) and severely obese (BMI ≥ 40.0), and the effect of BMI on disease-free survival (DFS) and overall survival (OS) was evaluated (median follow-up 65 months). In addition, subgroup analyses were conducted to assess the effect of BMI in luminal A-like, luminal B-like, HER2 (human epidermal growth factor 2)-positive and triple-negative tumors. RESULTS: Multivariate analyses revealed an independent prognostic effect of BMI on DFS (p = 0.001) and OS (p = 0.005). Compared with underweight/normal weight patients, severely obese patients had worse DFS (hazard ratio (HR) 2.70, 95 % confidence interval (CI) 1.71-4.28, p < 0.001) and OS (HR 2.79, 95 % CI 1.63-4.77, p < 0.001), while moderately obese, slightly obese and overweight patients did not differ from underweight/normal weight patients with regard to DFS or OS. Subgroup analyses showed a similar significant effect of BMI on DFS and OS in patients with triple-negative breast cancer (TNBC), but not in patients with other tumor subtypes. CONCLUSIONS: Severe obesity (BMI ≥ 40) significantly worsens prognosis in early breast cancer patients, particularly for triple-negative tumors. TRIAL REGISTRATION: Clinicaltrials.gov NCT02181101 . Registered September 2005.

Obesity as an independent risk factor for decreased survival in node-positive high-risk breast cancer.

Obese breast cancer patients have a higher risk of lymph node metastasis and a poorer prognosis compared to patients with normal weight. For obese women with node-positive breast cancer, an association between body weight and prognosis remains unclear. In this retrospective study, we analyzed patient data from the Phase-III ADEBAR trial, in which high-risk breast cancer patients (pT1-4, pN2-3, pM0) were randomized into a docetaxel-based versus epirubicin-based chemotherapy regimen. Patients were grouped according to their BMI value as underweight/normal weight (BMI < 25 kg/m(2); n = 543), overweight (BMI 25-29.9 kg/m(2); n = 482) or obese (BMI ≥ 30 kg/m(2); n = 285). Overweight and obese patients were older, had larger tumors and were more likely to be postmenopausal at the time of diagnosis compared to underweight/normal-weight patients (all p < 0.001). Multivariate Cox regression analyses adjusting for age and histopathological tumor features showed that obese patients had a significantly shorter disease-free survival (DFS; HR 1.43; 95 % CI 1.11-1.86; p = 0.006) and overall survival (OS; HR 1.56; 95 % CI 1.14-2.14; p = 0.006) than non-obese patients. Subgroup analyses revealed that the differences in DFS and OS were significant for postmenopausal but not for premenopausal patients, and that the survival benefit of non-obese patients was more pronounced in women with hormone-receptor-positive disease. Obesity constitutes an independent, adverse prognostic factor in high-risk node-positive breast cancer patients, in particular for postmenopausal women and women with hormone-receptor-positive disease.