Centralized Clinical Trial Imaging Data Management: Practical Guidance from a Comprehensive Cancer Center's Experience.

Medical imaging is an integral part of clinical trial research and it must be managed properly to provide accurate data to the sponsor in a timely manner (Clune in Cancer Inform 4:33-56, 2007; Wang et al. in Proc SPIE Int Soc Opt Eng 7967, 2011). Standardized workflows for site qualification, protocol preparation, data storage, retrieval, de-identification, submission, and query resolution are paramount to achieve quality clinical trial data management such as reducing the number of imaging protocol deviations and avoiding delays in data transfer. Centralization of data management and implementation of relational databases and electronic workflows can help maintain consistency and accuracy of imaging data. This technical note aims at sharing the practical implementation of our centralized clinical trial imaging data management processes to avoid the fragmentation of tasks among various disease centers and research staff, and enable us to provide quality, accurate, and timely imaging data to clinical trial sponsors.

Evaluation of ethical conflicts associated with randomized, controlled trials in critically ill children.

OBJECTIVE: To determine whether randomized, controlled trials (RCTS) of potentially life-sustaining therapies in critically ill infants and children cause an ethical conflict for physician investigators and if ethical conflicts affect protocol implementation. DESIGN: Descriptive survey. SUBJECTS: A convenience sample of 1,050 physicians from a national pediatric critical care meeting mailing list. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The survey return rate was 41% (n = 415). Of the returned surveys, 81% (n = 331) were answered by pediatric intensivists and fellows. The remaining 19% (n = 84) were completed by other physician subspecialists. Overall, 74% had experience with RCTs involving a potentially life-saving therapy (25% had experience with three or more trials, and 26% had never participated in this type of study). The vast majority of the respondents (96%) indicated that they believe RCTs of potentially life-sustaining therapies are ethical; however, only 10% stated that they never experienced an ethical conflict with these types of studies. Most respondents (84%) indicated that published data from uncontrolled trials may bias them toward an investigational therapy. Furthermore, only 35% of the respondents indicated that they always maintain strict protocol adherence when the condition of a control patient deteriorates and parents request the experimental treatment. There was a significant association between physicians who experienced an ethical conflict and the likelihood that they would do the following if the condition of a control patient deteriorated: fail to maintain strict protocol adherence (p = .05); alter the protocol in response to parental requests for the experimental treatment (p < .01); or seek compassionate use of the experimental treatment (p < .01). CONCLUSIONS: Although physicians consider RCTs of potentially life-sustaining therapies ethical, they acknowledge that this type of study sometimes creates an ethical conflict. Published results of uncontrolled trials lead to investigator bias in randomized trials and preclude equipoise. Our results indicate that RCTs involving life-sustaining therapies may be biased, lack consistent protocol implementation, and raise concern that data from these studies are potentially flawed.

Invisible costs, visible savings.

By identifying hidden inventory costs, nurse managers can save money for the organization. Some measures include tracking and standardizing supplies, accurately evaluating patients' needs, and making informed purchasing decisions.

The extent of drug therapy for attention deficit-hyperactivity disorder among children in public schools.

OBJECTIVES: The purpose of this study was to determine the extent of medication use for attention deficit-hyperactivity disorder (ADHD) in southeastern Virginia. METHODS: Students enrolled in grades 2 through 5 in school districts in city A (n = 5767 students) and city B (n = 23,967 students) were included. Nurses recorded students who received ADHD medication in school. RESULTS: The proportion of students receiving ADHD medication was similar in both cities (8% and 10%) and was 2 to 3 times as high as the expected rate of ADHD. Receipt of drug therapy was associated with social and educational characteristics. Medication was used by 3 times as many boys as girls and by twice as many Whites as Blacks. Medication use increased with years in school, and by fifth grade 18% to 20% of White boys were receiving ADHD medication. Being young for one's grade was positively associated with medication use (P < .01). The prevalence of ADHD was 12% in district A, 63% in district B. CONCLUSIONS: These findings suggest that criteria for diagnosis of ADHD vary substantially across US populations, with potential overdiagnosis and overtreatment of ADHD in some groups of children.

Attachment behavior, attachment security, and temperament during infancy.

In summary reviews and empirical research, investigators have suggested that attachment classifications derived from the Ainsworth Strange Situation may reflect variations along dimensions of temperament as well as, or perhaps instead of, individual differences with respect to infant-mother attachments. In this study, relations between temperament dimensions from the Infant Temperament Questionnaire (Revised) and Strange Situation behaviors were evaluated. Relations between the behavioral style scores and the categories of attachment quality were also tested. The hypothesis that temperamental difficulty would be related to negative emotionality, as indexed by infant distress during separation (but not during the reunions), was tested and supported. Neither the behavioral style dimensions nor the temperamental diagnoses (e.g., "easy" vs. "difficult") were associated significantly with attachment classifications. The results are consistent with previous findings that temperament measures do not predict attachment security. Nevertheless, certain behaviors indexing negative emotionality that may be observed in the context of the Strange Situation are related to temperamental variability.

The effects of chronic ganglion blockade and chronic cholinesterase inhibition on the sensitivity of rabbit stomach muscularis to cholinergic and adrenergic agonists.

The EC50 values, KA values and efficacies (e) of selected agonists have been determined in strips of stomach muscularis from control, chlorisondamine-pretreated and O, O-diethyl S[2(ethylthio)ethyl]phosphodithioate (disulfoton)-pretreated rabbits. Strips from chlorisondamine-pretreated animals were supersensitive to carbachol but normosensitive to phenylephrine; the e but the KA of carbachol was affected by this treatment. The KB of atropine was unchanged. Strips from animals treated with disulfoton were subsensitive to phenylephrine but normosensitive to amidephrine and carbachol; both the e and KA of phenylephrine appeared to be elevated by this pretreatment. The KB of phentolamine remained unchanged. These results indicate that the chlorisondamine-induced supersensitivity is the result of a change beyond the level of the cholinergic receptors. In contradistinction, the subsensitivity to phenylephrine after disulfoton pretreatment may result at least in part, from a qualitative change in the alpha adrenergic receptors in the stomach muscularis.