Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study.

BACKGROUND: Trastuzumab given intravenously in combination with chemotherapy is standard of care for patients with early HER2-positive breast cancer (BC). Different randomised studies have shown equivalent efficacy of a subcutaneous injection into the thigh compared to the intravenous formulation. Other body regions for injection have not been investigated but might be more convenient for patients. METHODS: After surgery, patients were randomised to receive either subcutaneous trastuzumab into the thigh or into the abdominal wall (AW). Patient preferences were evaluated using validated questionnaires (PINT). Primary objectives of this multicentre, non-blinded, randomised substudy of the GAIN-2 study were to investigate pharmacokinetics of the injection into the thigh versus AW and to determine patients' preferences of either administration site versus the previously received intravenous application. RESULTS: 226 patients were randomised and 219 patients (thigh: N = 110; AW: N = 109) formed the modified intent-to-treat (mITT). Overall, 83.5% (out of N = 182 with information about patients' preference) preferred subcutaneous over previous intravenous application or had no preference. Preference was similar between both administration sites (thigh: 80.6%; AW: 86.5; p = 0.322). Pharmacokinetic analysis included 30 patients. Geometric means of Cmax and AUC0-21d were higher in thigh than in AW group (geometric mean ratio with body weight adjustment: Cmax: 1.291, 90%-CI 1.052-1.584; AUC0-21d: 1.291, 90%-CI 1.026-1.626). Safety profile was in line with previous reports of subcutaneous trastuzumab. CONCLUSION: Subcutaneous trastuzumab into the thigh showed an approximately 30% higher bioavailability. Injections were well tolerated and preferred over intravenous administration. The subcutaneous injection into the thigh should remain the standard of care.

Smoking-attributable mortality in the autonomous communities of Spain, 2017.

INTRODUCTION AND OBJECTIVES: To estimate smoking-attributable mortality (SAM) in the regions of Spain among people aged ≥ 35 years in 2017. METHODS: SAM was estimated using a prevalence dependent method based calculating the population attributable fraction. Observed mortality was derived from the National Statistics Institute. The prevalence of smoking by age and sex was based on the Spanish National Health Survey for 2011 and 2017 and the European Survey for 2014. Relative risks were reported from the follow-up of 5 North American cohorts. SAM and population attributable fraction were estimated for each region by age group, sex, and causes of death. Cause-specific and adjusted SAM rates were estimated. RESULTS: Smoking caused 53 825 deaths in the population aged ≥ 35 years (12.9% of all-cause mortality). SAM ranged from 10.8% of observed mortality in La Rioja to 15.3% in the Canary Islands. The differences remained after rates were adjusted by age. The highest adjusted SAM rates were observed in Extremadura in men and in the Canary Islands in women. Adjusted SAM rates in men were inversely correlated with those in women. The percentage of total SAM represented by cardiovascular diseases in each region ranged from 21.8% in Castile-La Mancha to 30.3% in Andalusia. CONCLUSIONS: The distribution of SAM differed among regions. Conducting a detailed region-by-region analysis provides relevant information for health policies aiming to curb the impact of smoking.

Phase III randomised trial comparing intense dose-dense chemotherapy to tailored dose-dense chemotherapy in high-risk early breast cancer (GAIN-2).

BACKGROUND: The GAIN-2 trial was designed to identify a superior intense dose-dense (idd) strategy for high-risk patients with early breast cancer. Here, we report an interim analysis, at which the predefined futility boundary was crossed. PATIENTS AND METHODS: GAIN-2 was an open-label, randomised, multicentre phase III trial. Two thousand eight hundred and eighty seven patients were randomised 1:1 between three courses each of idd epirubicin (E) 150 mg/m2, nab-paclitaxel (nP) 330 mg/m2 and cyclophosphamide (C) 2000 mg/m2 (iddEnPC) versus four cycles of leucocyte nadir-based tailored and dose-dense EC (dtEC) followed by four cycles of tailored and dose-dense docetaxel (dtD) (dtEC-dtD). RESULTS: The duration of median follow-up was 45.8 (range 0.0-88.3) months. Trial objectives included invasive disease-free survival (iDFS) as the primary end-point. A total of 593 patients received the treatment as neoadjuvant chemotherapy. At the time of futility interim analysis, 414 events for iDFS were reported. Overall, there was no difference in iDFS between iddEnPC and dtEC-dtD with 4-year iDFS rates of 84.3% (95% confidence interval (CI) 82.0-86.4%). Among all predefined subgroups, hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-), lobular cancer and ≤50 years subgroups predicted for better iDFS in the dtEC-dtD arm. Overall, 88.1% of patients completed all treatment in both arms. Haematological toxicity grade 3/4 and grade 3/4 non-haematological adverse events were significantly higher with iddEnPC (iddEnPC 50.8% vs dtEC-dtD 45.1%, P = 0.002), especially arthralgia and peripheral sensory neuropathy. Two treatment-related deaths occurred during dtEC-dtD, corresponding to a low mortality rate of 0.07%. CONCLUSIONS: iDFS is equal in both regimens, but tailoring dose-dense chemotherapy improved outcomes in HR+/HER2-, lobular cancer and patients ≤50 years.

Utility of the CPS + EG scoring system in triple-negative breast cancer treated with neoadjuvant chemotherapy.

BACKGROUND: Pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) is associated with superior survival. This association is strongest in triple-negative breast cancer (TNBC). The CPS + EG system, based on pre-treatment clinical (CS) and post-treatment pathological stage (PS), oestrogen-receptor status (E) and grade (G), leads to a refined estimate of prognosis after NACT in all-comers and hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here, we investigate if CPS + EG scoring provides a superior estimate of prognosis in TNBC to select patients for postneoadjuvant therapy. METHODS: We calculated the CPS + EG score for 1795 patients with TNBC from 8 prospective German trials. Five-year disease-free survival (DFS) and overall survival estimates were calculated using the Kaplan-Meier method. RESULTS: In TNBC, patients with pCR (ypT0/is ypN0, n = 822, 45.8%) had a 5-year DFS of 86%, whereas patients with residual American Joint Committee on Cancer stage I disease (n = 383; 21.3%) had a 5-year DFS of 77.5%.CPS + EG led to superior prognostic information compared with that provided by the clinical stage, but it was inferior to the prognostic information provided by the pathological stage (c-index statistics, p < 0.001). CPS + EG did not discriminate prognosis within the two best prognostic groups (score 1 and 2; n = 362; 37.2%). In contrast, pCR status added prognostic information beyond CPS + EG. Patients with a CPS + EG score of 3 had a 5-year DFS rate of 64% overall, but those with pCR had a 5-year DFS rate of 84%, and those without pCR had a 5-year DFS rate of only 49.7%. CONCLUSIONS: In TNBC, CPS + EG scoring provided inferior prognostic information compared with the pathological stage and was unable to identify patients without pCR and with a sufficiently good prognosis, who could avoid postneoadjuvant therapy. pCR remains the strongest and most clinically useful prognostic factor after NACT. Other biologic factors beyond pCR are needed in TNBC.

Predicting Prognosis of Breast Cancer Patients with Brain Metastases in the BMBC Registry-Comparison of Three Different GPA Prognostic Scores.

Several scores have been developed in order to estimate the prognosis of patients with brain metastases (BM) by objective criteria. The aim of this analysis was to validate all three published graded-prognostic-assessment (GPA)-scores in a subcohort of 882 breast cancer (BC) patients with BM in the Brain Metastases in the German Breast Cancer (BMBC) registry. The median age at diagnosis of BM was 57 years. All in all, 22.3% of patients (n = 197) had triple-negative, 33.4% (n = 295) luminal A like, 25.1% (n = 221) luminal B/HER2-enriched like and 19.2% (n = 169) HER2 positive like BC. Age ≥60 years, evidence of extracranial metastases (ECM), higher number of BM, triple-negative subtype and low Karnofsky-Performance-Status (KPS) were all associated with worse overall survival (OS) in univariate analysis (p < 0.001 each). All three GPA-scores were associated with OS. The breast-GPA showed the highest probability of classifying patients with survival above 12 months in the best prognostic group (specificity 68.7% compared with 48.1% for the updated breast-GPA and 21.8% for the original GPA). Sensitivities for predicting 3 months survival were very low for all scores. In this analysis, all GPA-scores showed only moderate diagnostic accuracy in predicting the OS of BC patients with BM.

Mortalidad atribuida al consumo de tabaco en Brasil, 2016 / Mortality attributed to tobacco consumption in Brazil, 2016

RESUMEN: Objetivo: Actualizar la estimación de la mortalidad atribuida al consumo de tabaco en Brasil en población de 35 y más años. Métodos: Se aplicó un método dependiente de prevalencia, basado en la fracción atribuida poblacional. Este método estima la mortalidad atribuida a partir de la mortalidad observada en Brasil (fuente: Sistema de Información de Mortalidad del Sistema Único de Salud de Brasil-2016); de las prevalencias de fumadores, exfumadores y nunca fumadores (Encuesta Nacional de Salud de Brasil-2013) y del exceso de riesgo de morir (riesgo relativo) que tienen los fumadores y exfumadores en comparación con los nunca fumadores (5 estudios de cohortes norteamericanos). Se presentan estimaciones de mortalidad atribuida globales, por sexo, grupo de edad (35-54; 55-64; 65-74 y 75 años en adelante) y 3 grupos de enfermedades: tumores malignos, enfermedades cardiometabólicas y respiratorias. Resultados: En 2016, el consumo de tabaco causó con 163.831 muertes en Brasil, el 67% (109.369) fue en hombres y cuatro de cada diez (62.791) sucedieron antes de los 65 años. El 42% de la mortalidad atribuida se asocia a enfermedades cardiometabólicas, seguidas de respiratorias (34%) y tumorales (24%), sin diferencias por sexo. Conclusión: El 14% de las muertes que sucedieron en Brasil durante 2016 en población de 35 y más años se atribuye al consumo de tabaco. Realizar de forma periódica estimaciones de MA es necesario para valorar y fortalecer las leyes de control de tabaquismo implantadas.

ABSTRACT: Objective: To update the estimation of tobacco attributable mortality (AM) in the Brazilian population aged 35 years old and older. Methods: A prevalence-dependent analysis was applied based on the population attributed fraction. This method estimates the tobacco AM taking into account the mortality observed in Brazil (source: Brazilian Mortality Information System - 2016); the prevalence of smokers, former smokers, and never smokers (National Health Survey Brazil - 2013) and the excess of risk of death (relative risk) of smokers and former smokers in comparison to never smokers (derived from 5 North American cohorts). Estimates of overall AM are shown by gender, age group (35-54; 55-64; 65-74; and 75 years old and older) and 3 groups: malignant tumors, cardiometabolic diseases, and respiratory diseases. Results: In 2016, tobacco consumption caused 163,831 deaths in Brazil, 67% (109,369) were in men and four out of ten (62,791) occurred before the age of 65. Without differences by gender, 42% of the AM is associated with cardiometabolic diseases, followed by respiratory diseases (34%) and malignant tumors (24%). Conclusion: During 2016, 14% of the deaths occurred in the Brazilian population aged 35 years old and older were attributed to tobacco consumption. Periodic tobacco AM estimations are mandatory to assess and strengthen smoking control strategies and policies.

Mortality attributed to tobacco consumption in Brazil, 2016. / Mortalidad atribuida al consumo de tabaco en Brasil, 2016.

OBJECTIVE: To update the estimation of tobacco attributable mortality (AM) in the Brazilian population aged 35 years old and older. METHODS: A prevalence-dependent analysis was applied based on the population attributed fraction. This method estimates the tobacco AM taking into account the mortality observed in Brazil (source: Brazilian Mortality Information System - 2016); the prevalence of smokers, former smokers, and never smokers (National Health Survey Brazil - 2013) and the excess of risk of death (relative risk) of smokers and former smokers in comparison to never smokers (derived from 5 North American cohorts). Estimates of overall AM are shown by gender, age group (35-54; 55-64; 65-74; and 75 years old and older) and 3 groups: malignant tumors, cardiometabolic diseases, and respiratory diseases. RESULTS: In 2016, tobacco consumption caused 163,831 deaths in Brazil, 67% (109,369) were in men and four out of ten (62,791) occurred before the age of 65. Without differences by gender, 42% of the AM is associated with cardiometabolic diseases, followed by respiratory diseases (34%) and malignant tumors (24%). CONCLUSION: During 2016, 14% of the deaths occurred in the Brazilian population aged 35 years old and older were attributed to tobacco consumption. Periodic tobacco AM estimations are mandatory to assess and strengthen smoking control strategies and policies.

OBJETIVO: Actualizar la estimación de la mortalidad atribuida al consumo de tabaco en Brasil en población de 35 y más años. MÉTODOS: Se aplicó un método dependiente de prevalencia, basado en la fracción atribuida poblacional. Este método estima la mortalidad atribuida a partir de la mortalidad observada en Brasil (fuente: Sistema de Información de Mortalidad del Sistema Único de Salud de Brasil-2016); de las prevalencias de fumadores, exfumadores y nunca fumadores (Encuesta Nacional de Salud de Brasil-2013) y del exceso de riesgo de morir (riesgo relativo) que tienen los fumadores y exfumadores en comparación con los nunca fumadores (5 estudios de cohortes norteamericanos). Se presentan estimaciones de mortalidad atribuida globales, por sexo, grupo de edad (35-54; 55-64; 65-74 y 75 años en adelante) y 3 grupos de enfermedades: tumores malignos, enfermedades cardiometabólicas y respiratorias. RESULTADOS: En 2016, el consumo de tabaco causó con 163.831 muertes en Brasil, el 67% (109.369) fue en hombres y cuatro de cada diez (62.791) sucedieron antes de los 65 años. El 42% de la mortalidad atribuida se asocia a enfermedades cardiometabólicas, seguidas de respiratorias (34%) y tumorales (24%), sin diferencias por sexo. CONCLUSIÓN: El 14% de las muertes que sucedieron en Brasil durante 2016 en población de 35 y más años se atribuye al consumo de tabaco. Realizar de forma periódica estimaciones de MA es necesario para valorar y fortalecer las leyes de control de tabaquismo implantadas.

Characteristics and Clinical Outcome of Breast Cancer Patients with Asymptomatic Brain Metastases.

Background: Brain metastases (BM) have become a major challenge in patients with metastatic breast cancer. Methods: The aim of this analysis was to characterize patients with asymptomatic BM (n = 580) in the overall cohort of 2589 patients with BM from our Brain Metastases in Breast Cancer Network Germany (BMBC) registry. Results: Compared to symptomatic patients, asymptomatic patients were slightly younger at diagnosis (median age: 55.5 vs. 57.0 years, p = 0.01), had a better performance status at diagnosis (Karnofsky index 80-100%: 68.4% vs. 57%, p < 0.001), a lower number of BM (>1 BM: 56% vs. 70%, p = 0.027), and a slightly smaller diameter of BM (median: 1.5 vs. 2.2 cm, p < 0.001). Asymptomatic patients were more likely to have extracranial metastases (86.7% vs. 81.5%, p = 0.003) but were less likely to have leptomeningeal metastasis (6.3% vs. 10.9%, p < 0.001). Asymptomatic patients underwent less intensive BM therapy but had a longer median overall survival (statistically significant for a cohort of HER2-positive patients) compared to symptomatic patients (10.4 vs. 6.9 months, p < 0.001). Conclusions: These analyses show a trend that asymptomatic patients have less severe metastatic brain disease and despite less intensive local BM therapy still have a better outcome (statistically significant for a cohort of HER2-positive patients) than patients who present with symptomatic BM, although a lead time bias of the earlier diagnosis cannot be ruled out. Our analysis is of clinical relevance in the context of potential trials examining the benefit of early detection and treatment of BM.

Injury Occurrence in Male Handball Players and its Impact on Physical Constitution.

In male handball, limited knowledge exists about the body posture and postural control in correlation to their injury occurrence and their impact on physical constitution. 91 male handball players participated and were asked about playing position and years, NSAIDs intake, sustained injuries and therapy duration. A three-dimensional back scanner and a pressure measuring plate were used. Shoulder injuries cause a differing scapular height and increase the vertebrae rotation in correlation to playing years. Lower limb injuries lead to a decrease on the Centre of Pressure (CoP) with growing game experience. Wing players show the lowest injury risk. Lower limb and shoulder girdle are mostly affected regarding the incidence of injuries. Pivot players suffer most injuries in the lower limb area (59%), whereas wing players mostly have shoulder injuries (19%). Being injured, 21% of the players continue playing, 79% pause for a minimum of six months (25%). No correlation can be determined between level of profession, use of NSAIDs and body posture or postural control. Playing position, employment situation or NSAIDs have no influence on type of injury, body posture or postural control. While shoulder injuries can be recognized in the vertebrae area, lower limb injuries can affect the CoP.

Quality of life of patients with head and neck cancer after prophylactic percutaneous-gastrostomy.

BACKGROUND: HNC patients often experience weight loss during treatment. To date, there is only limited data on patient quality of life (QLQ) and subjective benefit of the PEG insertion. OBJECTIVE: To investigate the nutritional status, QLQ, and overall benefit. METHODS: 181 patients fitting our inclusion criteria (01/2012-12/2012) were enrolled. Utilization rate, nutritional status, QLQ, and subjective PEG assessment were determined with electronic charts and the Quality of life-questionnaire (EORTC-QLQ-C30). RESULTS: The utilization rate of the entire cohort was 91.7%. The PEG was used full-time by 149 patients. No statistical differences in QLQ were observed between the groups. Of the patients that used the PEG entirely (99.7%), partially (85.3%) or not all (55.3%) would 99.7%, 85.3 and 55.8% undergo the procedure in the future if necessary. CONCLUSIONS: QLQ was not significantly reduced by insertion. Especially patients using the PEG full-time had an objective and subjective benefit from the inserted PEG tube.

Semen cryopreservation in adolescent and adult men undergoing fertility compromising cancer treatment: A systematic review.

Treatment-related infertility is a common problem in cancer survivors. Semen cryopreservation is the most established option for male oncological patients wishing to preserve their fertility. We conducted a systematic review to analyse the existing literature regarding the frequency of offers and attempts of semen cryopreservation. We systematically searched MEDLINE and EMBASE for eligible literature without restrictions to language, study type or year of publication. Two authors independently screened and evaluated the citations for eligibility. Studies were included if they reported on pubertal or post-pubertal patients at risk of fertility impairment prior to their cancer therapy. We excluded studies neither reporting the prevalence of offer nor attempt of semen cryopreservation. Possible factors for heterogeneity between the studies were examined by meta-regression analyses. Out of 6,105 returned citations, 42 studies were included in the analysis. The prevalence of offer varied from 8% to 100% and corresponding attempts ranged from 3% to 79%, showing a vast heterogeneity with inconsistent reporting of influencing variables. Measured by the number of scientific publications, the awareness for fertility preservation is increasing while actual prevalences are diverse. In order to identify variables influencing offer and attempt prevalences, consistent reporting of a core set of factors is required.

The office work and stretch training (OST) study: an individualized and standardized approach for reducing musculoskeletal disorders in office workers.

BACKGROUND: Musculoskeletal disorders (MSD) are a common health problem in office workers. In Germany, MSD (mainly back pain related) are the main cause of workdays lost to incapacity. This is not only bothersome for the employees, but also causes higher costs for the health system and employers. Workplace health promotion programmes (WHPP) can help to reduce this as they reach large target groups and are easily accessible. In this context, stretch training exercises have already proven to be effective. In the present study, a new approach focusing on trunk extension is to be investigated. METHODS: To evaluate the training device "five-Business", 250 office workers will train two times a week for 3 months. The control group will consist of 100 office employees. The device "five-Business" enables five different full body exercises. The intervention will be evaluated before week one and after week twelve via three assessments: a) the Short Form-36 (SF-36) to record the general health status and health-related quality of life, taking into account physical, psychological and social factors, b) the Nordic Questionnaire to evaluate complaints of the musculoskeletal system, c) Range of Motion (ROM) measurements using a digital inclinometer and a measuring tape respectively. CONCLUSION: The "five-Business" combines elements of yoga and the McKenzie fundamentals, taking into account the Myers myofascial pathways in a highly torso-oriented, standardized stretching program. Due to the given exercise execution on the device and the individual adjustment possibilities of the stretching position (body size and range of motion) by the abutment, all exercises are individualized and standardized at the same time. In comparison to existing stretching interventions, this is a new approach in the framework of reducing musculoskeletal disorders and improving the quality of life in workplace health promotion.

Transcatheter Repair of Functional Mitral Regurgitation in Heart Failure Patients　- A Meta-Analysis of 23 Studies on MitraClip Implantation.

BACKGROUND: The aim of this study was to investigate long-term survival, clinical status, and echocardiographic findings of patients with severe functional mitral regurgitation (FMR) undergoing MitraClip (MC) treatment and to explore the role of baseline features on outcome. Methods and Results: Randomized and observational studies of FMR patients undergoing MC treatment were collected to evaluate the overall survival, New York Heart Association (NYHA) class and echocardiographic changes after MC treatment. Baseline parameters associated with mortality and echocardiographic changes were also investigated. Across 23 studies enrolling 3,253 patients, the inhospital death rate was 2.31%, whereas the mortality rate was 5.37% at 1 month, 11.87% at 6 months, 18.47% at 1 year and 31.08% at 2 years. Mitral regurgitation Grade <3+ was observed in 92.76% patients at discharge and in 83.36% patients at follow-up. At follow-up, 76.63% of patients NYHA Class I-II and there were significant improvements in left ventricular (LV) volume, ejection fraction, and pulmonary pressure. Atrial fibrillation (AF) had a significant negative effect on 1-year survival (ß=0.18±0.06; P=0.0047) and on the reduction in LV end-diastolic and end-systolic volumes (ß=-1.05±0.47 [P=0.0248] and ß=-2.60±0.53 [P=0.0024], respectively). CONCLUSIONS: MC results in durable reductions in mitral regurgitation associated with significant clinical and echocardiographic improvements in heart failure patients. AF negatively affects LV reverse remodeling and 1-year survival after MC treatment.

Severity of coronary artery disease is associated with non-alcoholic fatty liver dis-ease: A single-blinded prospective mono-center study.

BACKGROUND AND AIMS: Liver steatosis has shown to be associated with coronary artery disease (CAD). The aim of our study was to evaluate the association between the presence and severity of CAD and Non-alcoholic fatty liver disease (NAFLD) assessed by transient elastography (TE) and controlled attenuation parameter (CAP). METHODS: 576 Patients undergoing coronary angiography were enrolled in this prospective study, receiving at least 10 TE and CAP measurements using the FibroScan® M-probe. Clinically relevant CAD (CAD 3) was defined as stenosis with ≥75% reduction of the luminal diameter. NAFLD was determined by CAP ≥234 dB/m. NAFLD with advanced fibrosiswas determined by TE-values ≥7.9kPa in the presence of NAFLD and absence of congestive or right-sided heart failure. Rates and 95% confidence intervals are shown. RESULTS: 505 patients were available for analysis of NAFLD. However, only 392 patients were available for analysis of NAFLD with advanced fibrosis, since 24 patients had to be excluded due to non valid TE-measurements and 89 patients due to congestive or right-sided heart failure or suspected concomitant liver disease, respectively. 70.5% (66.3%-74.4%) of patients had CAD 3, 71.5% (67.3%-75.4%) were diagnosed with NAFLD, and 11.2% (8.3%-14.8%) with NAFLD with advanced fibrosis. Patients with CAD 3 had higher median CAP-values (273±61 vs. 260±66 dB/m; p = 0.038) and higher degrees of steatosis as compared to patients without CAD 3. While NAFLD was significantly more often diagnosed in patients with CAD 3 (75.0% vs. 63.1%, p = 0.0068), no significant difference was found for NAFLD with advanced fibrosis (10.7% vs. 12.5%, p = 0.60). CONCLUSIONS: Clinically relevant CAD is frequently associated with the presence of NAFLD, but not NAFLD with advanced fibrosis.

Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design.

OBJECTIVE: To determine whether the implementation of patient blood management (PBM) is effective to decrease the use of red blood cell without impairment of patient's safety. BACKGROUND: The World Health Organization encouraged all member states to implement PBM programs employing multiple combined strategies to increase and preserve autologous erythrocyte volume to minimize red blood cell transfusions. Data regarding safety issues are not sufficiently available. METHODS: In this prospective, multicenter study, surgical inpatients from four German University Hospitals were analyzed before (pre-PBM) and after the implementation of PBM. PBM program included multiple measures (ie, preoperative optimization of hemoglobin levels, blood-sparing techniques, and standardization of transfusion practice). Primary aim was to show noninferiority of the PBM cohort with a margin of 0.5%. Secondary endpoints included red blood cell utilization. RESULTS: A total of 129,719 patients discharged between July 2012 and June 2015 with different inclusion periods for pre-PBM (54,513 patients) and PBM (75,206 patients) were analyzed. The primary endpoint was 6.53% in the pre-PBM versus 6.34% in the PBM cohort. The noninferiority aim was achieved (P < 0.001). Incidence of acute renal failure decreased in the PBM cohort (2.39% vs 1.67%; P < 0.001, regression model). The mean number of red blood cell transfused per patient was reduced from 1.21 ±â€Š0.05 to 1.00 ±â€Š0.05 (relative change by 17%, P < 0.001). CONCLUSIONS: The data presented show that implementation of PBM with a more conscious handling of transfusion practice can be achieved even in large hospitals without impairment of patient's safety. Further studies should elucidate which PBM measures are most clinically and cost effective. TRIAL REGISTRATION: PBM-Study ClinicalTrials.gov, NCT01820949.

Medical work assessment in German hospitals: a study protocol of a movement sequence analysis (MAGRO-MSA).

BACKGROUND: Medical doctors are essential for the German public and occupational health system. They ensure the productivity of German society by enabling people to regain and recover their health. That is why the physicians' health and hence their productivity require special attention. Musculoskeletal disorders have a high prevalence in this work area. As a consequence, movement sequences, range of motions, and body postures of physicians in the course of the working day are in focus of this research project. METHODS: For this investigation 21 male or female junior physicians of various conservative medical disciplines will be covered. Data will be collected over one working day (approx. 9 hours). The CUELA system attached to the test person's body detects body posture and/or movements. This biomechanical measurement system ensures a locomotor and posture analysis that includes movement sequences, movement intensity, and range of motions to qualify the work tasks. For data analysis intra- and inter-professional comparisons are chosen. CONCLUSIONS: Working movement sequence analysis of physicians by means of the CUELA system is exclusive and novel in its focus. Up to now, knowledge of the working tasks of medical doctors has only been acquired by real-time observation approaches to work activity. In addition to this method of analysis, the CUELA system is able to record quantified biomechanical data about musculoskeletal loads of ordinary working tasks. Workloads and activities of physicians can be improved by ergonomic work design to reduce musculoskeletal disorders by utilizing the data collected. The healthcare system in Germany will thus be optimized by improving medical doctors' health. Consequently, MAGRO-MSA will also be used for other healthcare professions such as nurses and physicians assistants.

Prevalence of anemia in inflammatory bowel diseases in european countries: a systematic review and individual patient data meta-analysis.

BACKGROUND: The main objective is to determine the overall prevalence of anemia in inflammatory bowel diseases (IBD) in Europe. METHODS: A systematic literature search in PubMed and Embase was performed for studies published between January 2007 and May 2012. Eligible studies were included if they were original full-paper publications originated from Europe and if the authors agreed to provide their data. An overall prevalence of anemia in IBD, disease specific, and age-gender stratified basis prevalences were estimated. The influence of disease entity (Crohn's disease/ulcerative colitis), gender, age, disease activity (remission/active disease), and IBD-specific treatment strategies on the prevalence of anemia was analyzed by a mixed logistic regression model. Thereby, the factor country of origin was included as a random effect. RESULTS: Data were available for 2192 patients, mainly treated in tertiary referral centers. The overall prevalence of anemia in IBD patients was 24% (95% confidence interval, 18-31). Age-gender stratified prevalences were estimated for the age strata 18 to 29, 30 to 39, 40 to 49, 50 to 64, 65 to 74, >74 years and ranged from 18% to 35%. Patients receiving IBD-specific medication (P = 0.0002, odds ratio 1.54), and patients with active disease status (P < 0.0001, odds ratio 2.72) were significantly more likely to have anemia compared with patients not receiving IBD-specific medication or being in remission. Patients with ulcerative colitis tended to have anemia less likely than patients with Crohn's disease (P = 0.01, odds ratio 0.77). CONCLUSIONS: The overall prevalence of anemia in patients with Crohn's disease was 27% (95% confidence interval, 19-35) and 21% (95% confidence interval, 15-27) in patients with ulcerative colitis. Thereby, 57% of the anemic patients were iron deficient.