Design and Implementation of a Controlled Clinical Trial to Evaluate the Effectiveness and Efficiency of Routine Opt-out Rapid Human Immunodeficiency Virus Screening in the Emergency Department

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.     

Patient-reported outcomes in the Translational Breast Cancer Research Consortium

Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.     

Parvovirus B19 infection and Diamond-Blackfan anaemia

It is the purpose of the study to report the frequency of parvovirus in children with a diagnosis of Diamond-Blackfan anaemia and to discuss the possible aetiological role of parvovirus in Diamond-Blackfan anaemia. We found parvovirus DNA in 3 of 11 bone marrow smears. Giant pronormoblasts showed low sensitivity (33%) and poor specificity (75%). The presence of giant pronormoblasts was associated with a very high myeloid: erythroid ratio, and may not be specific for parvovirus infection, but a feature of severely suppressed erythropoiesis. The three parvovirus-positive patients were the only children who experienced a remission, and who are free of medication. The seven surviving parvovirus-negative patients are all currently on steroid treatment.     

Protein restriction in chronic renal failure

The aim of the study was to investigate the effect of a protein restricted diet on renal function and growth of children with chronic renal failure. In a multicentre prospective study 56 children (aged 2-18 years) with chronic renal failure were randomly assigned to the protein restricted (0.8-1.1 g/kg/day) or the control group. All children were followed up by the same paediatrician and dietitian. After a follow up period of three years there was no significant difference in glomerular filtration rate between children on a protein restricted diet and children of the control group. There was no significant difference in weight with respect to height and height SD score between the protein restricted and the control group. Compliance with the protein restricted diet, as indicated by the prospective diet diaries and the serum urea:creatinine ratio, was good. This study shows that children with chronic renal failure do not benefit from a protein restricted diet.     

A comparative study of the effects of cyclocytidine and norepinephrine on renin and esterase release from mouse submandibular gland

Summary The effects of cyclocytidine and norepinephrine on the release of renin and esterase from mouse submandibular gland were compared in in vivo and in vitro experiments. Cyclocytidine (150 mg/kg i.p.) produced the depletion of renin and esterase in in vivo experiments as did the -adrenoceptor agonist norepinephrine (1 mg/kg i.v.). Cyclocytidine was more effective in depleting renin and esterase than norepinephrine. The -adrenoceptor antagonist phenoxybenzamine (10 mg/kg i.p.), but not the -adrenoceptor antagonist propranolol (10 mg/kg i.p.), attenuated the depletion of renin and esterase by both cyclocytidine and norepinephrine. These results suggest that the mechanism of action of cyclocytidine on the release of renin and esterase in mouse submandibular gland could be similar to that of norepinephrine, and the secretory process for both cyclocytidine and norepinephrine could be initiated by activation of -adrenoceptors. In in vitro experiments using dispersed cells, cyclocytidine (10^–7 M–10^–2 M) had no effect on renin and esterase release, but dose-dependent release of both was clearly observed in response to norepinephrine (10^–7 M–10^–4 M). Immunocytochemical studies of renin in both in vivo and in vitro preparations showed similar enzymatic activity as measured by radioimmunoassay. The results of in vitro experiments did not correspond to those of in vivo experiments, which may suggest that the site of action of cyclocytidine in mouse submandibular gland may be different than that of norepinephrine. Pretreatment with bretylium (20 mg/kg, i.p.) prior to i.p. injection of cyclocytidine (150 mg/kg) completely blocked the esterase depletion induced by cyclocytidine. From these results, it seems possible to conclude that the in vivo effect of cyclocytidine on mouse submandibular gland is an indirect one and is mediated via reflex activation of sympathetic nerves.