A multicenter clinical trial of gadolite oral suspension as a contrast agent for MRI

The purpose of this study was to assess the effectiveness and safety of Gadolite Oral Suspension as a gastrointestinal (GI) contrast agent for MRI in a phase II and two phase III multicenter clinical trials. Gadolite was administered to 306 patients with known or suspected abdominal and/or pelvic disease. MRI with T1- and T2-weighted sequences was performed before and after ingestion. Efficacy was evaluated by having two masked readers rate the certainty of their MR diagnosis (0 = uncertain, 1 = probable, 2 = definite) on randomly presented pre- and post-Gadolite Oral Suspension enhanced images. Principal investigators also evaluated the images and established the final diagnosis. Vital signs, clinical chemistries, and adverse events were documented. Blood and urine samples were analyzed for gadolinium content to determine whether Gadolite Oral Suspension was absorbed systemically. Certainty in MR diagnosis increased significantly (P < .001) for both blinded readers between pre- and post-Gadolite images (.49–1.18 for reader 1; .46–1.53 for reader 2). Sensitivity, specificity, and accuracy also increased for both masked readers. No gadolinium was detected in blood or urine samples. There were no serious adverse events and no apparent drug-related trends in mean vital signs or laboratory values. Gadolite is a highly effective, safe, and well tolerated contrast agent for clinical use with MRI.     

Vagus Nerve Stimulation Induces a Sustained Anticonvulsant Effect

Summary: Purpose: Stimulation of the vagus nerve can effectively abort several types of experimentally induced seizures in animals when administered near the time of seizure onset. Indirect evidence from human trials and animal studies suggests that the anticonvulsant effects of vagus nerve stimulation (VNS) extend beyond the duration of stimulation. We used the pentylenetetrazol model to determine whether VNS exerts a persistent anticonvulsant effect.
Methods: VNS (1 mA, 30 Hz, 500 μs pulse width) was administered continuously for 0, 1, or 60 min, or intermittently (30 s on, 5 min off) for 60 min, to awake and freely moving animals. After the end of stimulation, pentylenetetrazol (50 mg/kg i.p.) was administered to induce seizures. Time-course studies were also performed, consisting of 60 min of VNS followed by pentylenetetrazol injection after 0, 3-, 5-, and 10-min intervals.
Results: The greatest anticonvulsant effect occurred after 60 min of continuous VNS, which prevented convulsions in four of 12 rats and reduced significantly seizure duration, the total number of seizures, and number of tonic seizures. Intermittent VNS was less effective than continuous stimulation for 60 min, but more effective than that for 1 min. The anticonvulsant effect declined in a time-dependent fashion after discontinuation of VNS, with return to nonstimulated control values by 10 min.
Conclusions: The results of this study verify a persistent VNS-induced anticonvulsant effect and indicate that its efficacy is dependent on the cumulative stimulus duration.     

Relationship with God and the Quality of Life of Prostate Cancer Survivors

This study explored the role of relationship with God with respect to the quality of life of men with prostate cancer. Thirty-four men with prostate cancer completed questionnaires on demographic and illness factors, aspects of relationship with God (e.g., God image), nonreligious resources (e.g., optimism) and physical, social and emotion functioning. Results showed that relationship with God was a significant factor in the prediction of role, emotional and social functioning for these men after controlling for age, reported severity of treatment reactions and nonreligious resources. Notably, different aspects of relationship with God (e.g., causal attribution) evidenced different associations with functioning and the nonreligious resource of perceived health control. Such results suggest that relationship with God may function in a complex manner as a resource in coping with prostate cancer. Longitudinal research is needed to clarify the role of religious/spiritual resources in the short- and long-term quality of life of men with prostate cancer.     

The Environmental Context of Patient Safety and Medical Errors

The environmental context of patient safety and medical errors was explored with specific interest in rural settings. Special attention was paid to unique features of rural: healthcare organizations and their environment that relate to the patient safety issue and medical errors (including the distribution of patients, types of adverse events associated with learning, information flows, triage and transfer decisions, and culture of safety). Relevant organizational theories and strategies fo medical error reduction and prevention in rural health care settings were identified. Financial and technical assistance are needed to support the systematic collection of data from rural hospitals and other entities and to enhance relevant patient safety practices for rural America.