Efficacy of vaccination with StroVac for recurrent urinary tract infections in women: a comparative single-centre study

International Urology and Nephrology - To assess the efficacy of prophylaxis for urinary tract infections (UTI) in a two-year follow-up in women with StroVac compared to a therapy with...     

Challenges and Opportunities for Real-World Evidence in Metastatic Luminal Breast Cancer

BackgroundThe therapeutic armamentarium for patients with metastatic breast cancer is becoming more and more specific. Recommendations from clinical trials are not available for all treatment situations and patient subgroups, and it is therefore important to collect real-world data.SummaryTo develop recommendations for up-to-date treatments and participation in clinical trials for patients with metastatic breast cancer, the Prospective Academic Translational Research PRAEGNANT Network was established to optimize the quality of oncological care in the advanced therapeutic setting. The main aim of PRAEGNANT is to systematically record medical care for patients with metastatic breast cancer in the real-life setting, including the outcome and side effects of different treatment strategies, to monitor quality-of-life changes during therapy, to identify patients eligible for participation in clinical studies, and to allow targeted therapies based on the molecular structures of breast carcinomas.Key MessagesThis article describes the PRAEGNANT network and sheds light on the question of whether the various end points from clinical trials can be transferred to the real-world treatment situation.     

Validation and psychometric properties of the 8-item Morisky Medication Adherence Scale (MMAS-8) in type 2 diabetes patients in Spain

AimsTo validate a translated and culturally adapted version of the Morisky Medication Adherence Scale for use in Spanish population, and to examine the psychometric properties of this scale in patients with type 2 diabetes mellitus in Spain.DesignThis cross-sectional study was conducted in a single university hospital in Spain. Patients diagnosed with type 2 diabetes mellitus at least 1 year before inclusion, being treated with anti-diabetic medication were included.InterventionWe used the Spanish version of the scale to measure treatment adherence.Principal measurementsthree level categorical scale is broken down into low adherence (score of <6), medium adherence (score of 6 to <8) and high adherence (score of 8). To validate the questionnaire, we measured internal consistency through Cronbach's α, confirmed construct validity through an exploratory principal component analysis and assessed test–retest reliability.Results232 patients met the inclusion criteria. The Cronbach's α coefficient was 0.40 (95% CI 0.28–0.52). The exploratory principal component analysis showed three components. The intraclass correlation coefficient was 0.718 (95% CI 0.564–0.823).Conclusionsthe Spanish version of the Morisky Medication Adherence scale showed low internal consistency, the exploratory factor analysis identified three dimensions, and the test–retest reliability was acceptable, therefore, psychometric properties of MMAS-8 are not suitable for measuring medication adherence in type 2 diabetes mellitus patients from Spain.     

Analysis of odontoblast gene expression using a novel approach,laser capture microdissection

Studying the mechanisms of molecular interactions in developing tissues demands sensitive molecular biological in vivo and in vitro techniques. Laser capture microdissection (LCM) allows for the isolation of mRNA in histological sections even from single cells, thus enabling the identification of in vivo gene expression products in closely circumscribed tissue areas. The aims of this study were to assess the optimal fixation, processing, and staining conditions to retrieve RNA from microdissected odontoblasts. Fluorometric assays and RT-PCR analysis of alpha 1(I) collagen, dentin sialophosphoprotein (Dspp), and osteocalcin (OC) confirmed that the total RNA isolated from day 0 and day 3 captured odontoblasts was sufficient in quantity and quality. Our results indicate that individual odontoblasts obtained by LCM are morphologically intact and chemically unaltered, allowing accurate molecular and biochemical analyses.     

Thrombocytopenia After Isolated Limb or Hepatic Perfusions with Melphalan: The Risk of Heparin-Induced Thrombocytopenia

Background: Three cases of heparin-induced thrombocytopenia (HIT) were observed in patients undergoing isolated limb perfusion (ILP) with melphalan. This occurrence prompted the discontinuation of prophylactic postoperative heparin in ILP patients and its avoidance in patients undergoing isolated hepatic perfusion (IHP). The need to reassess these decisions led to a review of thrombocytopenia in both patient populations.Methods: Records of all patients treated with ILP or IHP at our institution from July 1992 through November 1996, were reviewed. Nine IHP patients were tested prospectively for heparinrelated antibodies using serum samples obtained perioperatively and during the second postoperative week.Results: Thrombocytopenia (<100,000 platelets/L) developed postoperatively in 30% of 131 ILP patients and in 77% of 56 IHP patients. No cases of HIT were identified other than the three who had been previously diagnosed. The prevalence of HIT in heparinized ILP patients was 2.8% (3/108). All nine IHP patients developed heparin-related antibodies postoperatively.Conclusions: Because the prevalence of HIT following ILP is in the range observed in other clinical settings, postoperative heparin prophylaxis is an option. However, it probably should be limited to the first week, and daily platelet counts should be reviewed for a pattern of thrombocytopenia consistent with HIT. The prevalence of heparin-related antibodies after IHP is so high that prophylactic heparin should be avoided in this setting.