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Motl R.W.,University of Illinois at Urbana - Champaign | Weikert M.,University of Illinois at Urbana - Champaign | Suh Y.,University of Illinois at Urbana - Champaign | Sosnoff J.J.,University of Illinois at Urbana - Champaign | And 3 more authors.
Gait and Posture | Year: 2012

Background: Advances in portable sensor technology have opened an era for objective, real-life monitoring of walking speed in persons with multiple sclerosis (MS). Purpose: The present study examined the accuracy of the actibelt ® accelerometer for measuring walking speed during a standard 6-min walk (6MW) and the possibility that disability status influenced the degree of accuracy among persons with MS. Methods: On a single testing session, 51 persons with MS and Expanded Disability Status Scale scores between 2.0 and 6.5 performed a 6MW while wearing an actibelt ® in the body's sagittal symmetry plane and close to the body's centre of mass. Results: All 51 participants completed the 6MW without stopping, falling, or any adverse events, and the actibelt ® provided walking speed data for each of the participants. The actibelt ® significantly overestimated walking speed (actual minus actibelt ®) by a mean±standard deviation of -0.12±0.17m/s for the overall sample (p<0.0001). There was no significant overestimation in the sample with mild disability (-0.02±0.11m/s), but there was in the samples with moderate (-0.10±0.16m/s) and severe (-0.26±0.12m/s) disability. Conclusion: The actibelt ® is ready for real-life monitoring of walking speed in persons with mild MS, but caution is necessary when interpreting the accuracy of the walking speed data for those with MS who have moderate and severe disability. © 2011 Elsevier B.V.


Nitz U.,Heinrich Heine University Düsseldorf | Nitz U.,West German Study Group | Nitz U.,Ev. Bethesda Hospital | Gluz O.,West German Study Group | And 24 more authors.
Annals of Oncology | Year: 2014

Background: Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. WSG-AGO epiribicine and cyclophosphamide (EC)-Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes (LNs) only. Patients and methods: A total of 2011 BC patients (18-65 years, pN1) were entered into a randomized phase III trial comparing 4 × E90C600 q3w followed by 4 × docetaxel100 q3w (n = 1008) with the current standard: 6 × F500E100C500 q3w (n = 828) or C600M40F600 d1, 8× q4w (n = 175). Primary end point was event-free survival (EFS); secondary end points were overall survival (OS), toxicity, translational research, and quality of life. Central tumor bank samples were evaluable in a representative collective (n = 772; 40%). Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors. Results: Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset. At 59-month median follow-up, superior efficacy of EC-Doc [versus FEC (a combination of 5-fluorouracil, epirubicin, and cyclophosphamide)] was seen in EFS and OS: 5-year EFS: 89.8% versus 87.3% (P = 0.038); 5-year OS: 94.5% versus 92.8% (P = 0.034); both tests one-tailed. EC-Doc caused more toxicity. In hormone receptor-positive (HR)+ disease, only high-Ki-67 tumors (≥20%) derived significant benefit from taxane-based therapy: hazard ratio = 0.39 (95% CI 0.18-0.82) for EC-Doc versus FEC (test for interaction; P = 0.01). Conclusion: EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC (1-3 LNs) within all subgroups as defined by local pathology. In HR+ disease, patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy. Clinical Trial number: ClinicalTrials.gov, NCT02115204. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Stellmann J.-P.,University of Hamburg | Neuhaus A.,Trium Analysis Online GmbH | Daumer M.,Trium Analysis Online GmbH | Heesen C.,University of Hamburg
PLoS ONE | Year: 2014

Background: New agents with neuroprotective or neuroregenerative potential might be explored in primary-progressive Multiple Sclerosis (PPMS) - the MS disease course with leading neurodegenerative pathology. Identification of patients with a high short-term risk for progression may minimize study duration and sample size. Cohort studies reported several variables as predictors of EDSS disability progression but findings were partially contradictory. Objective: To analyse the impact of published predictors on EDSS disease progression in a large cohort of PPMS patients. Methods: A systematic literature research was performed to identify predictors for disease progression in PPMS. Individual case data from the Sylvia Lawry Centre (SLC) and the Hamburg MS patient database (HAPIMS) was pooled for a retrospective validation of these predictors on the annualized EDSS change. Results: The systematic literature analysis revealed heterogeneous data from 3 prospective and 5 retrospective natural history cohort studies. Age at onset, gender, type of first symptoms and early EDSS changes were available for validation. Our pooled cohort of 597 PPMS patients (54% female) had a mean follow-up of 4.4 years and mean change of EDSS of 0.35 per year based on 2503 EDSS assessments. There was no significant association between the investigated variables and the EDSS-change. Conclusion: None of the analysed variables were predictive for the disease progression measured by the annualized EDSS change. Whether PPMS is still unpredictable or our results may be due to limitations of cohort assessments or selection of predictors cannot be answered. Large systematic prospective studies with new endpoints are needed. © 2014 Stellmann et al.


PubMed | Germany; Trium Analysis Online GmbH, Trium Analysis Online GmbH and University of Hamburg
Type: Journal Article | Journal: PloS one | Year: 2015

Ecological validity implicates in how far clinical assessments refer to real life. Short clinical gait tests up to ten meters and 2- or 6-Minutes Walking Tests (2MWT/6MWT) are used as performance-based outcomes in Multiple Sclerosis (MS) studies and considered as moderately associated with real life mobility.To investigate the ecological validity of 10 Meter Walking Test (10mWT), 2MWT and 6MWT.Persons with MS performed 10mWT, 6MWT including 2MWT and 7 recorded days by accelerometry. Ecological validity was assumed if walking tests represented a typical walking sequence in real-life and correlations with accelerometry parameters were strong.In this cohort (n=28, medians: age=45, EDSS=3.2, disease duration=9 years), uninterrupted walking of 2 or 6 minutes occurred not frequent in real life (2.61 and 0.35 sequences/day). 10mWT correlated only with slow walking speed quantiles in real life. 2MWT and 6MWT correlated moderately with most real life walking parameters.Clinical gait tests over a few meters have a poor ecological validity while validity is moderate for 2MWT and 6MWT. Mobile accelerometry offers the opportunity to control and improve the ecological validity of MS mobility outcomes.


The overarching objective of the ITN is to offer an intercalated study environment for young and talented researchers in the field of coronary artery disease (CAD) research. 12 PhD fellows operating in a unique training environment will work as a multi-disciplinary team to perform research spanning the full spectrum from basic to translational to bring novel inventions to the bedside. The fellows will be mentored by world-leading experts to shape a new generation of European leaders in biomedical science and overcome current fragmentation in Europe. The research is at the forefront of biomedical science because of the UK genome-wide association study in 2000 myocardial infarction (MI) patients and our EU-FP6 integrated projects Bloodomics and Cardiogenics. We will exploit our knowledge about the genetic architecture of MI to investigate the hypothesis whether sequence variation of genes encoding network hubs poses a greater risk for network destabilisation compared to genes encoding regular nodes. Focusing on three hub genes we postulate that genetic/bio-markers associated with hubs can be integrated in algorithms for MI/CAD risk prediction. Success will critically depend on new developments in computing, machine learning, pattern recognition and advanced data mining and statistical analysis. To have a free development path from basic discovery to health care improvement young scientists must be taught to cross the classic barriers between academic disciplines. We offer a timely and necessary alternative to Europes classic PhD programmes by providing a seamlessly integrated multi-disciplinary environment in an academic-private sector partnership free of boundaries. Our aim is a targeted strategy for prevention and treatment based on a better understanding of the genetic and molecular mechanism of disease. This will deliver major advances in public health and patient care, which can only be achieved if a new scientific cadre is developed.


Schimpl M.,Trium Analysis Online GmbH | Moore C.,University of Cambridge | Sambrook J.,University of Cambridge | Danesh J.,University of Cambridge | And 2 more authors.
PLoS ONE | Year: 2011

Context: Walking speed is a fundamental parameter of human motion and is increasingly considered as an important indicator of individuals' health status. Objective: To evaluate the relationship of gait parameters, and demographic and physical characteristics in healthy men and women. Design, Setting, and Participants: Recruitment of a subsample (n = 358) of male and female blood donors taking part in the Cambridge CardioResource study. Collection of demographic data, measurement of physical characteristics (height, weight and blood pressure) and assessment of 7-day, free-living activity parameters using accelerometry and a novel algorithm to measure walking speed. Participants were a median (interquartile range[IQR]) age of 49 (16) years; 45% women; and had a median (IQR) BMI of 26 (5.4). Main Outcome Measure: Walking speed. Results: In this study, the hypothesis that walking speed declines with age was generated using an initial 'open' dataset. This was subsequently validated in a separate 'closed' dataset that showed a decrease of walking speed of -0.0037 m/s per year. This is equivalent to a difference of 1.2 minutes, when walking a distance of 1 km aged 20 compared to 60 years. Associations between walking speed and other participant characteristics (i.e. gender, BMI and blood pressure) were non-significant. BMI was negatively correlated with the number of walking and running steps and longest non-stop distance. Conclusion: This is the first study using accelerometry which shows an association between walking speed and age in free-living, healthy individuals. Absolute values of gait speed are comparable to published normal ranges in clinical settings. This study highlights the potential use of mobile accelerometry to assess gait parameters which may be indicative of future health outcomes in healthy individuals. © 2011 Schimpl et al.


PubMed | Dr. Horst Schmidt Kliniken Wiesbaden, Vivantes Klinikum Neukoelln, Kliniken Essen Mitte, Trium Analysis Online GmbH and 13 more.
Type: Journal Article | Journal: Breast cancer research and treatment | Year: 2016

The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC).This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360mg/m210 patients were randomized (n=105, PLD and n=105, capecitabine). Adjuvant anthracyclines were given to 37% (PLD) and 36% (capecitabine) of patients. No significant difference was observed in TTP [HR=1.21 (95% confidence interval, 0.838-1.750)]. Median TTP was 6.0months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P=0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3months vs. 26.8months) and time-to-treatment failure (median, 4.6months vs. 3.7months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P=0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8%; P=0.31).Both PLD and capecitabine are effective first-line agents for MBC.


Schimpl M.,Trium Analysis Online GmbH | Daumer M.,Trium Analysis Online GmbH
PLoS ONE | Year: 2011

Walking speed is a fundamental indicator for human well-being. In a clinical setting, walking speed is typically measured by means of walking tests using different protocols. However, walking speed obtained in this way is unlikely to be representative of the conditions in a free-living environment. Recently, mobile accelerometry has opened up the possibility to extract walking speed from long-time observations in free-living individuals, but the validity of these measurements needs to be determined. In this investigation, we have developed algorithms for walking speed prediction based on 3D accelerometry data (actibelt®) and created a framework using a standardized data set with gold standard annotations to facilitate the validation and comparison of these algorithms. For this purpose 17 healthy subjects operated a newly developed mobile gold standard while walking/running on an indoor track. Subsequently, the validity of 12 candidate algorithms for walking speed prediction ranging from well-known simple approaches like combining step length with frequency to more sophisticated algorithms such as linear and non-linear models was assessed using statistical measures. As a result, a novel algorithm employing support vector regression was found to perform best with a concordance correlation coefficient of 0.93 (95%CI 0.92-0.94) and a coverage probability CP1 of 0.46 (95%CI 0.12-0.70) for a deviation of 0.1 m/s (CP2 0.78, CP3 0.94) when compared to the mobile gold standard while walking indoors. A smaller outdoor experiment confirmed those results with even better coverage probability. We conclude that walking speed thus obtained has the potential to help establish walking speed in free-living environments as a patient-oriented outcome measure. © 2011 Schimpl et al.


Al-Batran S.-E.,Klinik fur Onkologie und Hamatologie Am Krankenhaus Nordwest | Guntner M.,Trium Analysis Online GmbH | Pauligk C.,Klinik fur Onkologie und Hamatologie Am Krankenhaus Nordwest | Scholz M.,Trium Analysis Online GmbH | And 6 more authors.
British Journal of Cancer | Year: 2010

Background:The aim of this study was to determine the activity of anthracycline rechallenge using pegylated liposomal doxorubicin (PLD) in patients with metastatic breast cancer (MBC) previously treated with conventional anthracyclines.Methods:Pooled individual data from four prospective trials were used, and the primary end point of the pooled analysis was clinical benefit rate (CBR). The studies comprised 935 patients, of whom 274 had received PLD in the metastatic setting after prior exposure to conventional anthracyclines (rechallenge population).Results:The majority of patients were heavily pretreated. Previous anthracycline therapy was administered in the adjuvant (14%) or metastatic setting (46%), or both (40%). The overall CBR from rechallenge with PLD was 37.2% (95% CI, 32.4-42.0). In univariate analyses, the CBR was significantly higher in patients with less exposure to prior chemotherapy, in taxane-naive patients, and in patients with a favourable Eastern Cooperative Group performance status of 0 vs 1 vs 2 (53.3 vs 35.5 vs 18.2%; P0.001). In multivariate analyses, performance status proved to be the only independent predictor of the CBR achieved with PLD rechallenge (P0.038). There was no statistically significant difference in CBR regarding the setting, cumulative dose of and/or resistance to prior anthracyclines, or time since prior anthracycline administration.Conclusion:Anthracycline rechallenge using PLD is effective in patients with MBC who have a favourable performance status, regardless of setting, resistance, cumulative dose or time since prior conventional anthracycline therapy. © 2010 Cancer Research UK All rights reserved.

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