Informed consent for treatment of childhood cancer: factors affecting parents' decision making

Both the treatment for childhood cancer and the legal requirements for gaining parents' consent to treatment have become increasingly complex. The purpose of the exploratory investigation reported here was to identify influential circumstances surrounding the consent process in the pediatric setting, to describe the relationship of parental anxiety to these factors, and to delineate related practice and research implications. Twenty-eight parents of children entered on one of four protocols for the treatment of newly diagnosed acute lymphoblastic leukemia at the Childrens Hospital Los Angeles and the University of California San Francisco were asked to complete two questionnaires within 48 hours after consenting to treatment: the State-Trait Anxiety Index and the Parent Informed Consent Questionnaire. Results of the study confirmed clinical experience that parents are given complex information and asked to make decisions about their child's life in a highly anxious state. Although participants were generally satisfied with the informed consent process 48 hours after signing a consent form, further research is needed to document how well parents understand and remember key information, as well as the influence of time, experience, and changes in state anxiety on their perceptions of the adequacy of the consent process. In current clinical practice, simple strategies can be applied to improve the informed consent process for families of children with cancer.     

Clinical Features of Crohn''s Disease in Ireland

Irish men and women are at equal risk of developing Crohn's disease. Age at diagnosis (12--mean 30.5-75 yr) and duration of symptoms before diagnosis (1--mean 35.7-444 months) are similar to those for Crohn's disease in other countries. The proportion of patients with macroscopic involvement of the large bowel at diagnosis (68%) is increasing and this is probably a true increase. At the same time the incidence of perianal disease is probably decreasing. Extraintestinal manifestations probably occur more frequently than previously recognized. Crohn's disease and psoriasis, which occurred in 7% of the patients, are probably associated disorders.     

Role of high-, low- and very low-density lipoproteins in the transport and tumor-delivery of hematoporphyrin in vivo

Free hematoporphyrin administered intravenously to healthy rabbits (1-28 mg/kg body weight) is bound by the 3 major lipoprotein components of plasma (VLDL, LDL and HDL) with different efficiency. In vitro-prepared complexes of hematoporphyrin (Hp) with lipoprotein fractions isolated from mouse serum have been injected intracardiacally into mice affected by MS-2 fibrosarcoma (1 mg of Hp per kg body weight). LDL appear to allow a more specific delivery of the complexed Hp to the tumor tissue as compared with HDL, VLDL or free Hp. The different behavior of VLDL, LDL and HDL as carriers of Hp in vivo is also discussed.     

Ultrasound detection of spontaneous rupture of accessory spleen: A case report

Accessory spleen rupture can induce acute abdominal bleeding following minimal trauma or by atraumatic mechanisms. Spleen rupture is more frequent in pediatric patients and those affected by hematological diseases. We described the case of a 59-year-old male patient affected by hereditary spherocytosis referred to the emergency department for abdominal left side pain. An early ultrasound performed in the emergency department allowed to diagnosed hemoperitoneum by spontaneous bleeding of hypertrophic accessory spleen. Although abdomen computed tomography is the diagnostic method of choice, ultrasound can early detect sign of emoperitoneum in the emergency setting in case of hemodinamically unstable patient.     

Gene therapy for diabetic foot ulcers: Interim analysis of a randomised,placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor

To evaluate the status of a 7-month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent-to-Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t-test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound-closing effects at month 6 (P = .0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P = .0391, .0391, and .0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P = .03 for all points). A potentially clinically meaningful 0.15 increase in Ankle-Brachial Index was observed in the VM202 group at day 210 in the ITT population (P = .0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites.