Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial

The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients

Therapeutic drug monitoring in adolescents with anorexia nervosa for safe treatment with adjunct olanzapine

Objective: Medication is commonly used in anorexia nervosa (AN) despite largely missing high grade evidence. Olanzapine (OLZ) is the best-evidenced substance used off-label in this group, with conflicting outcome regarding BMI, clinical and safety parameters. Therefore, it is important to strictly assure quality of treatment with OLZ in AN by using 'Therapeutic Drug Monitoring' according to AGNP-guidelines, including serum levels and adverse drug reactions (ADRs) to support safety for adolescents with AN and attempt to generate an initial age- and disorder-specific therapeutic reference range. Method: Sixty-five adolescents with AN (aged 10-18) treated with OLZ (98% female; 97.5% AN-restricting-type) were prospectively observed, ADRs reported, and correlations between dosage and serum levels measured at trough level were calculated, a preliminary therapeutic range defined. Results: Mean dosage of OLZ was 8.15 (SD: 2.91) mg and 0.19 (SD: 0.07) mg/kg respectively, average concentration was 26.57 (SD: 13.46) ng/mL. Correlation between daily dosage/dosage per kg and serum level was 0.72 (**p < 0.001)/0.65 (**p < 0.001), respectively. ADRs with impairment were rare (6.3%). 75% improved clinically (CGI). BMI increased significantly by 1.5 kg/m2 (t = 10.6, p < 0.001). A preliminary therapeutic reference range is 11.9 and 39.9 ng/mL. Conclusions: OLZ in the hands of specialists is a well-tolerated and safe treatment adjunct for adolescents with AN

Role of blood cells dynamism on hemostatic complications in low-risk patients with essential thrombocythemia

Patients with essential thrombocythemia (ET) aged less than 60 years, who have not suffered a previous vascular event (low-risk patients), may develop thrombotic or hemorrhagic events. So far, it has not been possible to identify useful markers capable of predicting which of these patients are more likely to develop an event and therefore who needs to be treated. In the present study, we analysed the relationship between vascular complications and longitudinal blood counts of 136 low-risk ET patients taken over a sustained period of time (blood cells dynamism). After a median follow-up of 60 months, 45 out of 136 patients (33%) suffered 40 major thrombotic and 5 severe hemorrhagic complications. A total number of 5,781 blood counts were collected longitudinally. Thrombotic and hemorrhagic events were studied together (primary endpoint) but also separately (thrombotic alone = secondary endpoint; hemorrhagic alone = tertiary endpoint). The primary endpoint showed no significant association between platelet and WBC count at diagnosis and risk of any event (platelet, p = 0.797; WBC, p = 0.178), while Hb at baseline did show an association (p = 0.024). In the dynamic analysis with Cox regression model, where the blood count values were studied by time of follow-up, we observed that the risk for Hb was 1.49 (95% CI 1.13-1.97) for every increase of 1 g/dL, and that this risk then marginally decreased during follow-up. WBC was associated with an increased risk at baseline for every increase of 1 7 10(9)/L (hazard ratio (HR) 1.07, 95% CI 1.01-1.13, p = 0.034), the risk was stable during follow-up (HR 0.95, p = 0.187 at 60 months). Also, for each increment at baseline of 100 7 10(9) platelets/L, HR was increased by 1.08 (95% CI 0.97-1.22, p = 0.159) and decreases during follow-up. In conclusion, this study is the first to evaluate in ET low-risk patients, the risk of developing a thrombotic/hemorrhagic event considering blood counts over time. Overall our study shows that the risk changes over time. For example, the risk associated with WCC is not linear as previously reported. An interesting new finding is that PLT and even Hb contribute to the risk of developing vascular events. Future treatments should take into consideration these findings and aim to control all parameters over time. We believe this early study may help develop a dynamic analysis model to predict thrombosis in the single patient. Further studies are now warranted to further validate our findings

Message-Based Patient Guidance in Day-Hospital

Day hospital workflows are highly dynamic. It is, therefore, important to provide patients with timely information about their next activity, where it takes place, and when it starts. In this paper we present MobiDay, a novel mobile service integrated in the hospital information system that supports patients and clinicians in a day hospital scenario. We describe the MobiDay message-posting algorithm that uses context-awarerules provided by clinicians to decide the time and content of the guidance messages sent to the patient's device. MobiDay was tested with real patients during a 4-months-long experiment held in the hospital of Meran in South Tyrol, Italy. Here we report on the system evaluation results. Moreover, we discuss the pros and cons of MobiDay design choices and propose some general guidelines for the development of effective message-based mobile guidance services for patients. \ua9 2011 IEEE

Surveying patients with smart devices

In this paper we investigate the impact of patient's profile on the usability of filling clinical questionnaires on smart devices. Our study was conducted in an oncological day hospital, where the EORTC QLQ-C30 quality of life questionnaire is administered to outpatients using computerized devices (smartphone, tablet, and laptop) and a paper form. We show that all the devices are evaluated as usable by the patients, under the dimension of easiness of use, and provided information. Moreover, we show that the patient's cognitive functioning (CF) impacts negatively on the evaluated usability of laptop-based surveys, suggesting that CF must be taken into account in the GUI design. Finally, we illustrate that the patient age and her technological skills also have a negative impact on the evaluated usability. \ua9 2012 IEEE

A multi-functional mobile information system for hospital assistance

Ospedale Amico (Friendly Hospital) is a mobile and personalized information system, aimed at improving the quality of the communication between medical staff and patients. The system provides the patients with up-to-date and context dependent day hospital activity guidance, and let them enter personal data and browse user-adapted descriptions of their disease. In this paper we describe the system functionality an discuss how we have addressed the limitations identified in the field study of an earlier prototype. \ua9 2013 IEEE

Epitaxial growth of Al-Cr-N thin films on MgO(111)

Cubic rock salt structure Al0.60Cr0.40N and Al0.68Cr0.32N films of different thicknesses were grown epitaxially onto MgO(111) substrates by reactive unbalanced magnetron sputtering at 500°C. Rutherford backscattering spectroscopy reveals stoichiometric nitrides with Al/Cr ratios close to the ones of the used compound targets of 60/40 and 70/30. High resolution x-ray diffraction proves epitaxial growth over the whole film thickness up to thicknesses of ~1.8 µm. Reciprocal space maps and selected area electron diffraction show that the AlxCr1-xN films grow fully relaxed. Scanning and transmission electron microscopy imaging reveals columnar microstructures with column widths between 12–16 nm and {001} surface faceting on individual columns. The fully relaxed growth and the columnar structure can be attributed to limited ad‑atom mobility on the initial AlxCr1-xN(111) growth surface.Original publication: H. Willmann, M. Beckers, J. Birch, P.H. Mayrhofer, C. Mitterer, and L. Hultman, Epitaxial growth of Al-Cr-N thin films on MgO(111), 2008, Thin Solid Films, (517), 2, 598-602.http://dx.doi.org/10.1016/j.tsf.2008.07.003. Copyright: Elsevier B.V., http://www.elsevier.com

Similarity of chemotherapy histories based on imputed values

The comparison of time series of multivariate data is a long-standing problem in many applications in the clinical domain. We propose two approaches to retrieve from a hospital data warehouse the k patients P1, ..., Pn with a chemotherapy history that is most similar to patient Q: the first is based on warping distance, together with an initial alignment using imputed values. The second is based on the volume of the Kiviat tube. In implementing the Euclidean distance, we investigate the addition of null events to achieve similar cardinality, and dynamic time warping, a widely-used technique in the comparison of time series data. The investigations are based on a real world clinical database