Brain tumors in children and adolescents and exposure to animals and farm life: a multicenter case-control study (CEFALO)

The etiology of brain tumors in children and adolescents is largely unknown, and very few environmental risk factors have been identified. The aim of this study was to examine the relationship between pre- or postnatal animal contacts or farm exposures and the risk of childhood brain tumors (CBTs), since infectious agents may pose a risk factor and a proposed mechanism is transferral of infectious agents from animals to humans.

A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial

The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease.

Different cardiac biomarkers to detect peri-procedural myocardial infarction in contemporary coronary stent trials: impact on outcome reporting

To assess the differential implications of cardiac biomarker type on peri-procedural myocardial infarction (PMI) reporting.

Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial

In this 12-month multicenter Scandinavian study, 78 maintenance heart transplant (HTx) recipients randomized to everolimus with reduced calcineurin inhibitor (CNI) exposure or continued standard CNI-therapy underwent matched virtual histology (VH) examination to evaluate morphological progression of cardiac allograft vasculopathy (CAV). Parallel measurement of a range of inflammatory markers was also performed. A similar rate of quantitative CAV progression was observed in the everolimus (n = 30) and standard CNI group (n = 48) (plaque index 1.9 ± 3.8% and 1.6 ± 3.9%, respectively; p = 0.65). However, VH analysis revealed a significant increase in calcified (2.4 ± 4.0 vs. 0.3 ± 3.1%; p = 0.02) and necrotic component (6.5 ± 8.5 vs. 1.1 ± 8.6%; p = 0.01) among everolimus patients compared to controls. The increase in necrotic and calcified components was most prominent in everolimus patients with time since HTx >5.1 years and was accompanied by a significant increase in levels of von Willebrand (vWF) factor (p = 0.04) and vascular cell adhesion molecule (VCAM) (p = 0.03). Conversion to everolimus and reduced CNI is associated with a significant increase in calcified and necrotic intimal components and is more prominent in patients with a longer time since HTx. A significant increase in vWF and VCAM accompanied these qualitative changes and the prognostic implication of these findings requires further investigation.

Definitions and outcome measures for bullous pemphigoid: recommendations by an international panel of experts

Our scientific knowledge of bullous pemphigoid (BP) has dramatically progressed in recent years. However, despite the availability of various therapeutic options for the treatment of inflammatory diseases, only a few multicenter controlled trials have helped to define effective therapies in BP. A major obstacle in sharing multicenter-based evidences for therapeutic efforts is the lack of generally accepted definitions for the clinical evaluation of patients with BP. Common terms and end points of BP are needed so that experts in the field can accurately measure and assess disease extent, activity, severity, and therapeutic response, and thus facilitate and advance clinical trials. These recommendations from the International Pemphigoid Committee represent 2 years of collaborative efforts to attain mutually acceptable common definitions for BP and proposes a disease extent score, the BP Disease Area Index. These items should assist in the development of consistent reporting of outcomes in future BP reports and studies.

Study design features affecting outcome in antidepressant trials

A key issue in the approval process of antidepressants is the inconsistency of results between antidepressant clinical phase III trials. Identifying factors influencing efficacy data is needed to facilitate interpretation of the results.

Integrated care in patients with schizophrenia: results of trials published between 2011 and 2013 focusing on effectiveness and efficiency

Purpose of review: Overview on integrated care trials focusing on effectiveness and efficiency published from 2011 to 2013. Recent findings: Eight randomized controlled trials (RCTs) and 21 non-RCT studies were published from 2011 to 2013. Studies differed in several methodological aspects such as study population, psychotherapeutic approaches used, outcome parameters, follow-up times, fidelities, and implementation of the integrated care model and the nation-specific healthcare context with different control conditions. This makes it difficult to draw firm conclusions. Most studies demonstrated relevant improvements regarding symptoms (P = 0.001) and functioning (P = 0.01), quality of life (P = 0.01), adherence (P <0.05) and patient's satisfaction (P = 0.01), and reduction of caregiver's stress (P < 0.05). Mean total costs were favoring or at least equalizing costs but with positive effects found on subjective health favoring integrated care models. Summary: There is an increasing interest in the effectiveness and efficiency of integrated care models in patients with mental disorders, specifically in those with severe and persistent mental illness. To increase generalizability, future trials should exactly describe rationales and content of integrated care model and control conditions.

Sentinel lymph node procedure leads to upstaging of patients with resectable colon cancer: results of the Swiss prospective, multicenter study sentinel lymph node procedure in colon cancer

The value of the sentinel lymph node (SLN) procedure in colon cancer patients remains a matter of debate. The objective of this prospective, multicenter trial was 3-fold: to determine the identification rate and accuracy of the SLN procedure in patients with resectable colon cancer; to evaluate the learning curve of the SLN procedure; and to assess the extent of upstaging due to the SLN procedure.

Gonadal function and fertility in survivors after Hodgkin lymphoma treatment within the German Hodgkin Study Group HD13 to HD15 trials

To optimize fertility advice in patients with Hodgkin lymphoma (HL) before therapy and during survivorship, information on the impact of chemotherapy is needed. Therefore, we analyzed gonadal functions in survivors of HL.

[Modalities of acupuncture treatments in assisted reproductive technology--a comparison of treatment practice in Swiss, German, and Austrian fertility centers with findings from randomized controlled trials]

One in 5 couples is affected by infertility. To increase the effectiveness of assisted reproductive technology (ART) adjuvant acupuncture treatments are frequently administered. However, little is known about acupuncture treatment modalities employed in fertility centers. The aim of our study was to assess modalities of acupuncture treatments in fertility centers and compare them with investigated acupuncture treatments in randomized controlled trials (RCTs) related to ART.