Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

Background  

High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003) we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment.     

Are Ecological and Social Models Influencing Prevention Practices? An Overview of the State of Affairs in Quebec for Child, Youth and Family Intervention

This paper presents the findings of a study designed to increase empirical knowledge of prevention and promotion practices targeted directly or indirectly at children, youth, and their families in the province of Quebec. A profile of these practices emerged from our analysis of the problems and concerns addressed by projects and programs in Quebec, targets for action, activities, strategies, links between organizations, and types of funding. These prevention and promotion practices are discussed in light of recent analyses and critiques in this field. It is hoped that this examination will encourage a healthy criticism of preventive efforts in Quebec, broaden of the scope of our interventions, and stimulate the creation of links between the actors involved in the welfare of children, youth, and families.     

TOXICITY AND BIOACCUMULATION OF NICKEL SULFATE IN SPRAGUE-DAWLEY RATS FOLLOWING 13 WEEKS OF SUBCHRONIC EXPOSURE

Adult male Sprague-Dawley rats were given 0, 0.02, 0.05, and 0.1% nickel sulfate (NiSO4 6H2O) or 0, 44.7, 111.75, and 223.5 mg Ni/L, respectively, in their drinking water for 13 wk. Twenty-four hours following the end of such treatment, all animals survived and no apparent clinical signs of toxicity were noted. The final mean body weights of various nickel sulfate-treated rats were not significantly decreased except for the 0.1% nickel sulfate treated group when compared to those in the control. The absolute and relative organ weights were either increased or decreased or remained unchanged, depending on the organ and the dose of nickel sulfate. Total plasma proteins, plasma albumin and globulins, and plasma glutamic pyruvic transaminase activity were all significantly decreased in 0.1% nickel sulfate-treated rats. Lymphocyte subpopulations (T and B cells) were induced at lower dose levels, but suppressed at the highest (0.1 %) dose group. A significant decrease in urine volume and an increase in BUN were observed at the highest dose group. Biochemical analysis of bronchoalveolar lavage fluid and lung tissue showed some lung damage, whereas no damage to the testis or DNA in liver and kidneys were found. No gross or microscopic changes were seen in any of the various tissues examined. The relative order of bioaccumulation of nickel in different organs of rats when treated at 0.1% nickel sulfate (223.5 mg Ni/L) was kidneys > testes > lung = brain > spleen > heart = liver. But with regard to order of toxicity, both immune and pulmonary systems were found to be very sensitive targets, followed by kidney.     

Electrical stimulation versus extracorporeal magnetic innervation for urinary incontinence after radical prostatectomy

Nurses use several conservative methods for treating urinary incontinence after radical prostatectomy. Functional electrical stimulation (FES) has a recognized role, while extracorporeal magnetic innervation (ExMI) is still under evaluation in the international guidelines. Few data are available in literature, regarding comparisons between these two treatments. The aim of the study is to compare electrical stimulation and magnetic innervation for treating urinary incontinence after radical prostatectomy. Twenty‐two patients treated with ExMI and 18 treated with FES were enrolled in a retrospective study. ExMI was available for 6 weeks; the number of times ExMI was required by the patients to reduce their leakages to 10 g/d or less was compared. The groups had comparable age and body mass index. Initial leakages showed clinically relevant differences (median = 80 g/d in the ExMI patients and 150 g/d in the FES group). After 6 weeks, 71·9% of ExMI patients and 29·2% of FES patients had completed rehabilitation. The difference was statistically significant even after adjusting the analyses for initial leakages (p = 0·008). Six patients treated with ExMI had already undergone FES, with no clinically relevant results after five sessions (leakages reduction <50 g/d). The difference remained even after removing the data of these patients from the analysis (p = 0·004). Both FES and ExMI produce muscle strengthening, which is just one step of rehabilitation. Our findings suggest the possibility of using ExMI instead of FES to reduce the times required to improve muscular performance. Pelvic muscle exercises remain essential to develop the ability to automatically perform the contractions needed to avoid leakages.