Using electronic health records to support clinical trials: a report on stakeholder engagement for EHR4CR

Background. The conduct of clinical trials is increasingly challenging due to greater complexity and governance requirements as well as difficulties with recruitment and retention. Electronic Health Records for Clinical Research (EHR4CR) aims at improving the conduct of trials by using existing routinely collected data, but little is known about stakeholder views on data availability, information governance, and acceptable working practices. Methods. Senior figures in healthcare organisations across Europe were provided with a description of the project and structured interviews were subsequently conducted to elicit their views. Results. 37 structured interviewees in Germany, UK, Switzerland, and France indicated strong support for the proposed EHR4CR platform. All interviewees reported that using the platform for assessing feasibility would enhance the conduct of clinical trials and the majority also felt it would reduce workloads. Interviewees felt the platform could enhance trial recruitment and adverse event reporting but also felt it could raise either ethical or information governance concerns in their country. Conclusions. There was clear support for EHR4CR and a belief that it could reduce workloads and improve the conduct and quality of trials. However data security, privacy, and information governance issues would need to be carefully managed in the development of the platform

Risky sexual behaviours of high-school pupils in an era of HIV and AIDS

Objective. To identify risky sexual behaviours and demographic factors that place high-school pupils at risk of HIV and AIDS. Methods. A cross-sectional study was undertaken to explore factors influencing the sexual behaviour of high-school pupils (mean age 15.4 years; SD 1.11). Structured self-reported questionnaires were completed by all grade 10 pupils (N=805) at all the Wentworth, Durban, public high schools. Results. Significant gender differences in sexual practices were reported, such as males being more likely to engage in sexual activity than females (OR 4.92;

The Short-Term Dynamics of Peers and Delinquent Behavior: An Analysis of Bi-weekly Changes Within a High School Student Network

_Objectives:_ To analyze short-term changes in peer affiliations, offending behavior and routine activities in order to evaluate three different processes: peer selection, peer socialization an

Methods to improve recruitment to randomised controlled trials : Cochrane systematic review and meta-analysis

Peer reviewedPublisher PD

Developmental toxicity study of sodium molybdate dihydrate administered in the diet to Sprague Dawley rats

AbstractMolybdenum is an essential nutrient for humans and animals and is a constituent of several important oxidase enzymes. It is normally absorbed from the diet and to a lesser extent from drinking water and the typical human intake is around 2μg/kg bodyweight per day. No developmental toxicity studies to contemporary standards have been published and regulatory decisions have been based primarily on older studies where the nature of the test material, or the actual dose levels consumed is uncertain.In the current study the developmental toxicity of sodium molybdate dihydrate as a representative of a broad class of soluble molybdenum(VI) compounds, was given in the diet to Sprague Dawley rats in accordance with OECD Test Guideline 414. Dose levels of 0, 3, 10, 20 and 40mgMo/kgbw/day were administered from GD6 to GD20. No adverse effects were observed at any dose level on the dams, or on embryofetal survival, fetal bodyweight, or development, with no increase in malformations or variations. Significant increases in serum and tissue copper levels were observed but no toxicity related to these was observed. The NOAEL observed in this study was 40mgMo/kgbw/day, the highest dose tested

Candida dubliniensis candidemia in patients with chemotherapy-induced neutropenia and bone marrow transplantation.

The recently described species Candida dubliniensis has been recovered primarily from superficial oral candidiasis in HIV-infected patients. No clinically documented invasive infections were reported until now in this patient group or in other immunocompromised patients. We report three cases of candidemia due to this newly emerging Candida species in HIV-negative patients with chemotherapy-induced immunosuppression and bone marrow transplantation

Exercise capacity and incidence of myocardial perfusion defects after Kawasaki disease in children and adolescents

Objectives.This study evaluated exercise performance and myocardial perfusion during exercise in patients with Kawasaki disease who had a broad spectrum of residual coronary abnormalities.Background.Reports of exercise performance after Kawasaki disease have generally included a small number of patients evaluated by various protocols, frequently with incomplete data. Myocardial perfusion studies have usually been limited to those using pharmacologically induced coronary vasodilation. Therefore, to our knowledge there has not been a large study directly correlating exercise performance, electrocardiographic (ECG) changes and myocardial perfusion imaging.Methods.Forty-six patients were classified into three groups on the basis of coronary artery status: group 1 (n = 27) had no objective evidence of coronary artery lesions; group 2 (n = 11) had resolved aneurysms; group 3 (n = 8) had persistent coronary aneurysms. All patients underwent exercise testing with monitor ing of ECG changes and oxygen consumption. Single-photon emission computed tomographic imaging was performed at rest and during peak exercise using technetium-99m sestamibi.Results.Maximal oxygen consumption was within normal limits and was similar for all three groups. Five patients had mild ST segment changes at peak exercise. Two of these patients had stress-induced perfusion defects. Myocardial perfusion defects were present in 37% of patients in group 1, 63% in group 2 and 100% in group 3. Perfusion defects corresponded to the coronary artery lesion site in all but three patients.Conclusions.Maximal oxygen consumption is normal after Kawasaki disease regardless of coronary artery status. Stressinduced perfusion defects are frequent even in the absence of coronary abnormalities and are common in the absence of ST segment changes suggestive of ischemia

Population of 13Be in a Nucleon Exchange Reaction

The neutron-unbound nucleus 13Be was populated with a nucleon-exchange reaction from a 71 MeV/u secondary 13B beam. The decay energy spectrum was reconstructed using invariant mass spectroscopy based on 12Be fragments in coincidence with neutrons. The data could be described with an s-wave resonance at E = 0.73(9) MeV with a width of Gamma = 1.98(34) MeV and a d-wave resonance at E = 2.56(13) MeV with a width of Gamma = 2.29(73) MeV. The observed spectral shape is consistent with previous one-proton removal reaction measurements from 14B.Comment: Published in Phys. Rev.