EORTC Radiation Oncology Group quality assurance platform: establishment of a digital central review facility.

OBJECTIVE: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT. METHODS: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers. RESULTS: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results. CONCLUSIONS: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes.

Avaluació de la teratogènia in vitro mitjançant el cultiu d’embrions sencers (WEC)

Projecte de recerca elaborat a partir d’una estada a la Charité - Universitätsmedizin Berlin, Alemanya, entre novembre i desembre del 2007. En aquest treball es presenta el protocol a seguir per a dur a terme el cultiu d’embrions sencers in vitro (Whole Embryo Culture, WEC). Amb aquest protocol es pretén implementar la tècnica del WEC en el laboratori de la Unitat de Toxicologia de la Facultat de Farmàca (UB), seguint la metodologia apresa durant l’estada i deixant per escrit tots els passos seguits i el material i la metodologia concreta de cadascun d’ells. En el WEC es cultiven embrions de rata de 9.5 dies durant 48h en ampolles rotatòries en un medi líquid i amb una fase gasosa controlats. Durant el cultiu, tenen lloc dos processos principals: el plegament de l’embrió i l’organogènesi. Els embrions durant els dos dies que dura el cultiu es pleguen en els plans transversal i sagital, passant d’un embrió pla a un altre de cilíndric en forma de “C”. En aquest període, a més, es produeixen importants processos d’organogènesi com la neurulació, la formació de la cresta neural, dels somites, dels vasos sanguinis - el cor inclòs- i de la sang. Es comencen a formar la placoda nasal, la vesícula oftàlmica, la vesícula òtica, les extremitats superiors i inferiors i la cua. En la memòria adjunta es descriuen amb detall els processos d'aparellament dels animals, preparació del material i del medi de cultiu, el procés d'aïllament del embrions en el dia 9.5, les condicions de cultiu i l'avaluació dels embrions en el dia 11.5. Finalment es presenten resultats d'embrions en situació control amb un correcte desenvolupament i es mostra com, al final de l'estada, es va aconseguir el cultiu d’embrions control amb un desenvolupament correcte i estadísticament sense diferències respecte als diferents paràmetres mesurats en comparació amb els embrions control de la Charité-Universitätsmedizin de Berlin.

Effect of epinephrine on oxygen consumption and delivery during progressive hemorrhage.

OBJECTIVE: To determine whether, during hemorrhagic shock, the effect of epinephrine on energy metabolism could be deleterious, by enhancing the oxygen requirement at a given level of oxygen delivery (DO2). DESIGN: Prospective, randomized, control trial. SETTING: Experimental laboratory. SUBJECTS: Two groups of seven mongrel dogs were studied. The epinephrine group received a continuous infusion of epinephrine (1 microgram/min/kg) while the control group received saline. INTERVENTION: Dogs were anesthetized with pentobarbital, and shock was produced by stepwise hemorrhage. MEASUREMENTS AND MAIN RESULTS: Oxygen consumption (VO2) was continuously measured by the gas exchange technique, while DO2 was independently calculated from cardiac output (measured by thermodilution) and blood oxygen content. A dual-lines regression fit was applied to the DO2 vs. VO2 plot. The intersection of the two regression lines defined the critical value of DO2. Values above critical DO2 belonged to phase 1, while phase 2 occurred below critical DO2. In the control group, VO2 was independent of DO2 during phase 1; VO2 was dependent on DO2 during phase 2. In the epinephrine group, the expected increase in VO2 (+19%) and DO2 (+50%) occurred under normovolemic conditions. During hemorrhage, VO2 immediately decreased, and the slope of phase 1 was significantly (p < .01) different from zero, and was significantly (p < .05) steeper than in the control group (0.025 +/- 0.005 vs. 0.005 +/- 0.010). However, the critical DO2 (8.7 +/- 1.7 vs. 9.7 +/- 2.4 mL/min/kg), the critical VO2 (5.6 +/- 0.5 vs. 5.5 +/- 0.9 mL/min/kg), and the slope of phase 2 (0.487 +/- 0.080 vs. 0.441 +/- 0.130) were not different from control values. CONCLUSIONS: The administration of pharmacologic doses of epinephrine significantly increased VO2 under normovolemic conditions due to the epinephrine-induced thermogenic effect. This effect progressively decreased during hemorrhage. The critical DO2 and the relationship between DO2 and VO2 in the supply-dependent phase of shock were unaffected by epinephrine infusion. These results suggest that during hemorrhagic shock, epinephrine administration did not exert a detrimental effect on the relationship between DO2 and VO2.

Use of Existing Meningococcal Group C Vaccine - Students in Higher Education (PDF 20KB)

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Report of the National Joint Steering Group on the Working Hours of Non Consultant Hospital Doctors

The introduction of a maximum 48 hour working week for Non Consultant Hospital Doctors by 2010 will have significant implications for both Doctors in training and service delivery in our hospitals. This report focuses on how this reduction in working hours can be achieved and the many directly related issues that need to be addressed Download the Report here

Protecting Our Future - Report of the Working Group on Elder Abuse

The Working Group on Elder Abuse is pleased to present this Report. It provides a foundation for the development of policy and procedures to respond to actual or alleged cases of elder abuse.  Aim of policy and proceduresThe aim of the policy and procedures presented here is to create a context in which older people and those concerned about the abuse of older people can disclose their concerns and receive an appropriate response. The basis of the policy (and the procedures flowing from it) is the recognition of the right of older people to live independent lives with dignity. Download document here

Second Report of the Working Group on Child and Adolescent Psychiatric Services

Second Report of the Working Group on Child and Adolescent Psychiatric Services The Minister for Health and Children established a Working Group on Child and Adolescent Psychiatry in June 2000 with the following terms of reference:·  To examine the current state of child and adolescent psychiatric services in the country; ·  To carry out a needs analysis of the population aged 0-18 years for such services and to identify shortcomings in meeting such needs; ·  To make recommendations on how child and adolescent psychiatric services should be developed in the short, medium and long term to meet identified needs. Click here to download PDF 58kb

Treatment of severe infectious purpura in children with human plasma from donors immunized with Escherichia coli J5: a prospective double-blind study. J5 study Group.

To evaluate the efficacy of anti-J5 serum in the treatment of severe infectious purpura, 73 children were randomized to receive either anti-J5 (40) or control (33) plasma. Age, blood pressure, and biologic risk factors were similar in both groups. At admission, however, tumor necrosis factor serum concentrations were 974 +/- 173 pg/ml compared with 473 +/- 85 pg/ml (P = .023) and interleukin-6 serum concentrations were 129 +/- 45 compared with 19 +/- 5 ng/ml (P = .005) in the control and treated groups, respectively. The duration of shock and the occurrence of complications were similar in both groups. The mortality rate was 36% in the control group and 25% in the treated group (P = .317; odds ratio, 0.76; 95% confidence interval, 0.46-1.26). This trend disappeared after correction for unbalances in risk factors at randomization using a logistic regression model. These results suggest that anti-j5 plasma did not affect the course or mortality of severe infectious purpura in children.

Second Report of the Working Group on Child and Adolescent Psychiatric Services

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The National Primary Care Steering Group - Progress Report

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Report of the Expert Group on Midwifery and Children's Nursing Education

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