Randomized controlled trial of laxative use in postcolostomy surgery patients.

PURPOSE: We compared a standardized postoperative laxative protocol to laxatives provided on an ad hoc basis by the surgical team. SUBJECTS AND SETTING: Forty-five patients who underwent colostomy surgery participated in the study. The research setting was 2 acute care facilities in south-eastern Sydney, New South Wales, Australia. METHODS: A randomized controlled trial was conducted. The intervention group (n 5 19) received a standardized laxative protocol postsurgery. Two types of laxatives were selected for first-line treatment: sterculia and frangula bark (Normacol Plus), a bulking agent and stimulant; and liquid paraffin (Agarol), a stool softener. An iso-osmotic polyethylene glycol macrogel (Movicol) was chosen as second-line treatment. The comparison group (n = 26) received laxative intervention(s) as preferred by the surgical team. Constipation, measured as fecal loading on plain abdominal film, stomal therapy nurse activity, patient comfort, and length of hospital stay were compared between intervention and control groups. RESULTS: The presence of fecal loading favored the intervention group (1 episode in the treatment group vs 7 episodes in the comparison group; χ5 = 3.8; P = .05). This finding suggests that the laxative protocol given to the treatment group was more likely to prevent fecal loading/constipation when compared to the ad hoc laxative group. Stomal therapy nurse activity in terms of the number of empty bag changes was significantly higher in the comparison group (F 5 4.8; P 5 .03). CONCLUSION: The findings of this study support the benefits of a standardized laxative protocol for prevention of constipation. Data collection was discontinued after 3 years due to a contamination effect developing, because our surgeons observed the utility of the laxative protocol and incorporated it into their routine practice. Further experimental research is needed to explore the best constipation prevention approaches for postcolostomy surgery patients.

Controlled evaluation of the effects of hyperbaric oxygen therapy on the behavior of 16 children with autism spectrum disorders.

Hyperbaric oxygen therapy (HBOT) has been used to treat individuals with autism. However, few studies of its effectiveness have been completed. The current study examined the effects of 40 HBOT sessions at 24% oxygen at 1.3 ATA on 11 topographies of directly observed behavior. Five replications of multiple baselines were completed across a total of 16 participants with autism spectrum disorders. No consistent effects were observed across any group or within any individual participant, demonstrating that HBOT was not an effective treatment for the participants in this study. This study represents the first relatively large-scale controlled study evaluating the effects of HBOT at the level of the individual participant, on a wide array of behaviors.

Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: influence of gestational age and birth weight.

This study examined whether acquisition of neonatal reflexes in newborn rhesus macaques was influenced by receipt of a single neonatal dose of hepatitis B vaccine containing the preservative thimerosal (Th). Hepatitis B vaccine containing a weight-adjusted Th dose was administered to male macaques within 24 h of birth (n = 13). Unexposed animals received saline placebo (n = 4) or no injection (n = 3). Infants were tested daily for acquisition of nine survival, motor, and sensorimotor reflexes. In exposed animals there was a significant delay in the acquisition of root, snout, and suck reflexes, compared with unexposed animals. No neonatal responses were significantly delayed in unexposed animals. Gestational age (GA) and birth weight (BW) were not significantly correlated. Cox regression models were used to evaluate main effects and interactions of exposure with BW and GA as independent predictors and time-invariant covariates. Significant main effects remained for exposure on root and suck when controlling for GA and BW, such that exposed animals were relatively delayed in time-to-criterion. Interaction models indicated there were various interactions between exposure, GA, and BW and that inclusion of the relevant interaction terms significantly improved model fit. This, in turn, indicated that lower BW and/or lower GA exacerbated the adverse effects following vaccine exposure. This primate model provides a possible means of assessing adverse neurodevelopmental outcomes from neonatal Th-containing hepatitis B vaccine exposure, particularly in infants of lower GA or BW. The mechanisms underlying these effects and the requirements for Th requires further study.

Influence of pediatric vaccines on amygdala growth and opioid ligand binding in rhesus macaque infants: A pilot study.

This longitudinal, case-control pilot study examined amygdala growth in rhesus macaque infants receiving the complete US childhood vaccine schedule (1994-1999). Longitudinal structural and functional neuroimaging was undertaken to examine central effects of the vaccine regimen on the developing brain. Vaccine-exposed and saline-injected control infants underwent MRI and PET imaging at approximately 4 and 6 months of age, representing two specific timeframes within the vaccination schedule. Volumetric analyses showed that exposed animals did not undergo the maturational changes over time in amygdala volume that was observed in unexposed animals. After controlling for left amygdala volume, the binding of the opioid antagonist [(11)C]diprenorphine (DPN) in exposed animals remained relatively constant over time, compared with unexposed animals, in which a significant decrease in [(11)C]DPN binding occurred. These results suggest that maturational changes in amygdala volume and the binding capacity of [(11)C]DPN in the amygdala was significantly altered in infant macaques receiving the vaccine schedule. The macaque infant is a relevant animal model in which to investigate specific environmental exposures and structural/functional neuroimaging during neurodevelopment.

WITHDRAWN: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing Hepatitis B vaccine: Influence of gestational age and birth weight.

This article has been withdrawn at the request of the editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.

The Childhood Asperger Syndrome Test (CAST): test-retest reliability in a high scoring sample.

The Childhood Asperger Syndrome Test (CAST) is a 37-item parental self-completion questionnaire designed to screen for high-functioning autism spectrum conditions in epidemiological research. The CAST has previously demonstrated good accuracy for use as a screening test, with high sensitivity in studies with primary school aged children in mainstream schools. This study aimed to investigate test-retest reliability of the CAST in a high scoring sample. To this end, 73 parents filled in the second CAST (CAST-2) within approximately 2 months of the first administration of the CAST (CAST-1). Agreement above and below the cut-point of 15 was investigated. The kappa statistic for agreement (<15 versus > or =15) was 0.41. It was found that 70 percent (95% CI: 58, 80) of children did not move across the cut-point of 15. The correlation between the two test scores was 0.67 (Spearman's rho). The CAST shows moderate test-retest reliability in a high scoring sample, further evidence that it is a relatively robust screening tool for epidemiological research.

The Childhood Asperger Syndrome Test (CAST): test-retest reliability.

The Childhood Asperger Syndrome Test (CAST) is a 37-item parental self-completion questionnaire to screen for autism spectrum conditions in research. Good test accuracy was demonstrated in studies with primary school aged children in mainstream schools. The aim of this study was to investigate the test-retest reliability of the CAST. Parents of 1000 children in years 1-6 in five mainstream primary schools in Cambridgeshire received the CAST. A second identical questionnaire was posted to respondents after approximately 2 weeks. Both mailings generated 136 responses. Agreement above and below a screening cut-point of 15 was investigated. The kappa statistic for agreement (< 15 versus > or = 15) was 0.70, and 97 percent (95 percent CI: 93-99 percent) of children did not move across the cut-point of 15. The correlation between the two test scores was 0.83 (Spearman's rho). The CAST has shown good test-retest reliability, and now requires further investigation in a high-scoring sample.

The CAST (Childhood Asperger Syndrome Test): test accuracy.

The Childhood Asperger Syndrome Test (CAST) is a parental questionnaire to screen for autism spectrum conditions. In this validation study, the CAST was distributed to 1925 children aged 5-11 in mainstream Cambridgeshire schools. A sample of participants received a full diagnostic assessment, conducted blind to screen status. The sensitivity of the CAST, at a designated cut-point of 15, was 100 percent, the specificity was 97 percent and the positive predictive value was 50 percent, using the group's consensus diagnosis as the gold standard. The accuracy indices varied with the case definition used. The sensitivity of the accuracy statistics to case definition and to missing data was explored. The CAST is useful as a screening test for autism spectrum conditions in epidemiological research. There is not currently enough evidence to recommend the use of the CAST as a screening test within a public health screening programme in the general population.

Screening for speech and language disorders: the reliability, validity and accuracy of the General Language Screen.

This paper reports the reliability, validity and accuracy of the General Language Screen (GLS) as the first stage in its development as a potential screening instrument for the identification of speech and language disorder (SLD) in the primary care setting. Data reported were obtained during the Cambridge Language and Speech Project (CLASP) a longitudinal epidemiological study of primary SLD. The GLS was originally used in initial CLASP sample ascertainment when children were aged 36 months. This report utilises speech and language data collected at subsequent stages of this study (37-months, 45-months and 8-years) to determine the reliability, validity and accuracy of the GLS. The GLS demonstrated sufficient levels of reliability (internal consistency alpha = 0.74) and validity (criterion validity r = -0.55). Adequate construct validity was demonstrated by a factor analysis in which two language related factors were identified. These data therefore justified exploration of the accuracy of the GLS as a screening instrument. Analysis of accuracy in this context is complicated by lack of a generally accepted method of defining SLD case status. This report utilises data on language function at different stages of development to provide measures of GLS accuracy over time. Concurrent accuracy, measured against parental report of language function at 37-months, was good (ROC area under the curve = 0.93). Predictive accuracy measured against direct assessment of speech and language at 45-months and 8-years was, as expected, somewhat less (ROC = 0.77 and 0.68 respectively). The implications for the use of the GLS as a screening instrument are discussed. The data indicate that the GLS would function most usefully as the first stage of a two-stage screen for SLD in the primary care setting. Recommendations are made as to the nature of the second stage of such a screen and plans for future research are outlined.