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These data suggest that quality of life in dementia is complex, and that simple proxy substitutions of discrete measures such as cognition or function are likely to miss important factors.

DEMQOL and DEMQOL-Proxy show psychometric properties that are comparable with the best available dementia-specific measures of HRQL. We recommend that DEMQOL and DEMQOL-Proxy are used together. Reliability and validity need to be confirmed in independent samples and responsiveness needs to be evaluated.

6 9What ' s known on the subject? and What does the study add? Population-based studies implicate an increased incidence of complications after prostate needle biopsy. Such information is essential for adequate patient counselling before the procedure.A limitation of population-based studies is the absence of individual patient data to better characterize the nature of post-biopsy complications. This study of 1000 consecutive patients treated at a single centre highlights hospital admissions as well as Emergency Department visits for patients after prostate needle biopsy. Importantly, it allows for characterization of specifi c complications, aetiologies, management and outcomes for affected patients.

This report describes 7-year-old Afro-Caribbean monozygotic twin boys who both presented with bilateral unerupted mesiodentes palatal to the central incisors. There have been two previous similar reports. From this case and previous reports it was concluded that mesiodentes in monozygotic twins are likely to be concordant with respect to the number of supernumerary teeth. Unilateral mesiodens usually have been mirror imaged in each twin. Minor discordance between monozygotic twins is common with respect to the shape (conical, incisiform or tuberculate) and orientation (inverted or normal) of individual mesiodens within and between each twin.

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation.Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions.In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Background Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile octreotide in hospitalized infants has not been described; we sought to fill this information gap. Methods We identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. We collected laboratory and clinical information while infants were exposed to octreotide and described the frequency of baseline diagnoses, laboratory abnormalities, and adverse events (AEs). Results A total of 428 infants received 490 courses of octreotide. The diagnoses most commonly associated with octreotide use were chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%). The most common laboratory AEs that occurred during exposure to octreotide were thrombocytopenia (47/1000 infant-days), hyperkalemia (21/1000 infant-days), and leukocytosis (20/1000 infant-days). Hyperglycemia occurred in 1/1000 infant-days and hypoglycemia in 3/1000 infant-days. Hypotension requiring pressors (12%) was the most common clinical AE that occurred during exposure to octreotide. Necrotizing enterocolitis was observed in 9/490 (2%) courses, and death occurred in 11 (3%) infants during octreotide administration. Conclusion Relatively few AEs occurred during off-label use of octreotide in this cohort of infants. Additional studies are needed to further evaluate the safety, dosing, and efficacy of this medication in infants.

Background Population pharmacokinetic (popPK) models derived from small PK studies in neonates are often underpowered to detect clinically important characteristics that drive dosing. External validation of such models is crucial. In this study, the predictive performance of a gentamicin popPK model in neonates receiving hypothermia was evaluated. Methods A previously published gentamicin popPK model was developed in neonates with hypoxic ischemic encephalopathy undergoing hypothermia using a retrospective single-institution (UCSF) dataset. The predictive performance of this model was evaluated in an external retrospective dataset from UCSF (Validation A) and another from Duke University (Validation B). Both institutions used the same hypothermia protocol and collected similar clinical and PK data. Gentamicin dosing and samples were collected per routine care. Predictive performance was evaluated by quantifying the accuracy and precision of model predictions and using simulation-based diagnostics to detect bias in predictions. Results 41 neonates (18 Validation A, 23 Validation B) with median (range) gestational age of 40wks (33–42) and birth weight of 3.3kg (1.9–4.6) and 76 samples (55% troughs, 33% and 28% drawn at 24 and 36h post dose, respectively) were analyzed. The model adequately predicted gentamicin concentrations from the same institution (Validation A; median average fold error [AFE]=1.1 and numerical prediction distribution error [NPDE] p-value>0.05) but under-predicted concentrations from the outside institution (Validation B; median AFE=0.6 and NPDE p-value<0.05). Conclusion The model demonstrated adequate predictive performance for an external dataset in the same institution but not from an outside institution. Larger sample sizes, use of data from multiple institutions, and external evaluation in development of popPK models in neonates may improve generalizability of dosing recommendations arising from single-institution studies.