Communication of randomization in childhood leukemia trials

Context  Most children diagnosed as having leukemia become research subjects in randomized clinical trials (RCTs), but little is known about how randomization is explained to or understood by parents. Objective  To investigate physicians' explanation and parental understanding of randomization in childhood leukemia RCTs. Design and Setting  A multisite study of the informed consent communication process for RCTs of childhood leukemia. Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US children's hospitals associated with major academic medical centers from July 1, 1999, until December 31, 2001. The informed consent conferences were observed and audiotaped, and the information obtained was coded and analyzed. Parents were interviewed shortly after the conference to ascertain their understanding. Participants  Parents and members of the health care team who participated in 137 informed consent conferences for children with newly diagnosed acute leukemia. Main Outcome Measures  Observed explanations of randomization and parental understanding of randomization after the consent conference. Results  Randomization was explained by physicians in 83% of cases and a consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (P<.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial. Conclusions  Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.      

HDL and inflammation in atherosclerosis

Atherosclerotic vascular disease is among the most frequent causes of death worldwide. Current therapeutic strategies concentrate mainly on lowering of low-density lipoprotein (LDL) cholesterol and an impressive reduction in the risk for cardiovascular morbidity and mortality has been achieved. Inflammatory mechanisms are more and more recognized to play an important role in vascular disease as inflammatory markers correlate with prognosis in acute and chronic coronary artery disease. HDL cholesterol exerts anti-inflammatory effects on the vasculature. Moreover, HDL is an antioxidant, inhibits thrombogenesis, and has pro-fibrinolytic properties. Last but not least, HDL mediates reverse cholesterol transport. These pleiotropic effects make HDL an ideal therapeutic target for novel therapeutic strategies specifically aiming at HDL elevation for the prevention and treatment of atherosclerotic vascular disease.     

A controlled longitudinal study of the social functioning of children with juvenile rheumatoid arthritis

OBJECTIVE: To complete an assessment of social functioning of children with juvenile rheumatoid arthritis (JRA) and nonchronically ill controls who had been evaluated 2 years earlier (Noll et al., 2000) and to examine the impact of disease severity or disease activity over time on the social functioning of children with JRA. METHODS: Peer-, teacher-, and self-reports of social functioning were obtained from 57 children with JRA and 63 controls. Social reputation and social acceptance were examined cross-sectionally and longitudinally. RESULTS: Cross-sectional analyses indicated no significant differences between children with JRA and controls on measures of social functioning. For children with more severe disease, like ratings declined over the 2-year period relative to children with mild disease. Children with active disease were chosen fewer times over the 2-year period as a best friend than children in remission. CONCLUSIONS: Because children with severe or active JRA may be at risk for difficulties with social acceptance over time, they are appropriate targets for interventions that ameliorate or prevent these difficulties.     

Randomized clinical trial of PCR-determined human papillomavirus detection methods: self-sampling versus clinician-directed--biologic concordance and women's preferences

OBJECTIVE: The purpose of this study was to compare the high-risk human papillomavirus detection rates from self-sampled swabs and tampons with standard clinician-directed speculum sampling and to assess women's acceptance of self-sampling methods. STUDY DESIGN: One hundred three women who required a colposcopy underwent order randomization of the human papillomavirus sampling technique. Kappa and McNemar test statistical results were used to measure the agreement between clinician-directed and self-sampling techniques for high-risk types of human papillomavirus and the acceptance of self-sampling techniques. RESULTS: All self-directed samplings were equivalent to clinician sampling for all cervical intraepithelial neoplasia disease states. High-risk human papillomavirus was detected by self- and clinician-directed methods in 83% of the women with cervical intraepithelial neoplasia, grade 2/3. The 2 sequential swabs trend toward better detection of high-risk types of human papillomavirus than all other techniques for women with normal histologic factors (P =.0736, by McNemar's chi2 test). Ninety-four percent of women would accept self-sampling for their yearly cervical screen. CONCLUSION: Self-sampling is equivalent to clinician sampling for the detection of high-risk human papillomavirus and is acceptable to women as a yearly screen.     

The Long-term Physical Health and Healthcare Utilization of Women Who Were Sexually Abused as Children

This article addresses the relationship between childhood sexual abuse and the long-term physical health and healthcare utilization of 148 female participants in an eight-year prospective study. Five factors of physical health emerged: General Health; Vegetative Health Symptoms; Colds and Flu; Gastrointestinal/Gynecological; and Healthcare Utilization. Abused females scored higher on the healthcare utilization and gastrointestinal/gynecological factors than comparison females. Abused females experiencing multiple perpetrators, violence, longer duration and older age at onset endorsed significantly more gastrointestinal/gynecological problems than did the other abused females and the comparison group. Findings suggest that: (1) sexual abuse affects long-term health outcomes and healthcare utilization; and (2) physical health sequelae of abuse may differentially affect females, depending upon the pattern of abuse characteristics.