Prevention of excess weight gain in paediatric primary care: beverages only or multiple lifestyle factors. The Smart Step Study, a cluster-randomized clinical trial.

BACKGROUND: Insufficient evidence exists to support obesity prevention in paediatric primary care. OBJECTIVES: To test a theory-based behaviour modification intervention delivered by trained paediatric primary care providers for obesity prevention. METHODS: Efficacy trial with cluster randomization (practice level) and a 12-session 12-month sweetened beverages decrease intervention or a comprehensive dietary and physical activity intervention, compared with a control intervention among children ages 8-12 years. RESULTS: A low recruitment rate was observed. The increase in body mass index z-score (BMIz) for the 139 subjects (11 practices) randomized to any of the two obesity interventions (combined group) was less than that of the 33 subjects (five practices) randomized to the control intervention (-0.089, 95% confidence interval [CI]: -0.170 to -0.008, P = 0.03) with a -1.44 kg weight difference (95% CI: -2.98 to +0.10 kg, P = 0.095). The incidences of obesity and excess weight gain were lower in the obesity interventions, but the number of subjects was small. Post hoc analyses comparing the beverage only to the control intervention also showed an intervention benefit on BMIz (-0.083, 95% CI: -0.165 to -0.001, P = 0.048). CONCLUSIONS: For participating families, an obesity prevention intervention delivered by paediatric primary care clinicians, who are compensated, trained and continuously supported by behavioural specialists, can impact children's BMIz.

Inhaled corticosteroids versus sodium cromoglycate in children and adults with asthma.

BACKGROUND: Inhaled corticosteroids (ICS) and sodium cromoglycate (SCG) have become established as effective controller medications for children and adults with asthma, but their relative efficacy is not clear. OBJECTIVES: To compare the relative effectiveness and adverse effects of ICS and SCG among children and adults with chronic asthma. SEARCH STRATEGY: Systematic search of the Cochrane Airways Group's special register of controlled trials (to Feb. 2004), hand searches of the reference lists of included trials and relevant review papers, and written requests for identification of additional trials from pharmaceutical manufacturers. SELECTION CRITERIA: Randomized controlled trials comparing the effect of ICS with SCG in children and adults with chronic asthma. DATA COLLECTION AND ANALYSIS: All studies were assessed independently for eligibility by three review authors. Disagreements were settled by consensus. Trial authors were contacted to supply missing data or to verify methods. Eligible studies were abstracted and fixed- and random-effects models were implemented to pool studies. Separate analyses were conducted for paediatric and adult studies. Subgroup analyses and meta-regression models were fit to explore heterogeneity of lung function outcomes by type of RCT, category of ICS or SCG dosage, asthma severity of participants, and study quality on outcomes. MAIN RESULTS: Of 67 identified studies, 17 trials involving 1279 children and eight trials involving 321 adults with asthma were eligible. Thirteen (76%) of the paediatric studies and six (75%) of the adult studies were judged to be high quality. Among children, ICS were associated with a higher final mean forced expiratory volume in 1 second [FEV1] (weighted mean difference [WMD] 0.07 litres, 95% confidence interval [CI] 0.02 to 0.11) and higher mean final peak expiratory flow rate [PEF] (WMD 17.3 litres/minute, 95% CI 11.3 to 23.3) than SCG. In addition, ICS were associated with fewer exacerbations (WMD -1.18 exacerbations per year, 95% CI -2.15 to - 0.21), lower asthma symptom scores, and less rescue bronchodilator use than SCG. There were no group differences in the proportion of children with adverse effects. Among adults, ICS were similarly associated with a higher mean final FEV1 (WMD 0.21 litres, 95% CI 0.13 to 0.28) and a higher final endpoint PEF (WMD 28.2 litres/minute, 95% CI 18.7 to 37.6) than SCG. ICS were also associated with fewer exacerbations (WMD -3.30 exacerbations per year, 95% CI -5.62 to -0.98), lower asthma symptom scores among cross-over trials but not parallel trials, and less rescue bronchodilator use than SCG. There were no differences in the proportion of adults with adverse effects. In subgroup analyses involving lung function measures, paediatric and adult studies judged to be of high quality had results consistent with the overall results. Lung function measures in children were higher in studies with medium BDP-equivalent steroid dosages than low BDP-equivalent dosages, while adult studies could not be compared by steroid dosage since they all incorporated similar dosages. There were no significant differences in lung function by the asthma severity of participants for adult or child studies. AUTHORS' CONCLUSIONS: ICS were superior to SCG on measures of lung function and asthma control for both adults and children with chronic asthma. There were few studies reporting on quality of life and health care utilization, which limited our ability to adequately evaluate the relative effects of these medications on a broader range of outcomes. Although there were no differences in adverse effects between ICS and SCG, most trials were short and may not have been of sufficient duration to identify long-term effects. Our results support recent consensus statements in the U.S. and elsewhere that favour the use of ICS over SCG for control of persistent asthma.

Identifying newborns at risk of significant hyperbilirubinaemia: a comparison of two recommended approaches.

AIMS: To compare the predictive performance of clinical risk factor assessment and pre-discharge bilirubin measurement as screening tools for identifying infants at risk of developing significant neonatal hyperbilirubinaemia (post-discharge total serum bilirubin (TSB) >95th centile). METHODS: Retrospective cohort study of term and near term infants born in an urban community teaching hospital in Pennsylvania (1993-97). A clinical risk factor scoring system was developed and its predictive performance compared to a pre-discharge TSB expressed as a risk zone on a bilirubin nomogram. Main outcome measures were prediction model discrimination, range of predicted probabilities, and sensitivity, specificity, positive and negative predictive values, and likelihood ratios for various positivity criteria. RESULTS: The clinical risk factor scoring system developed included birth weight, gestational age <38 weeks, oxytocin use during delivery, vacuum extraction, breast feeding, and combination breast and bottle feeding. The pre-discharge bilirubin risk zone had better discrimination (c = 0.83; 95% CI 0.80 to 0.86) than the clinical risk factor score (c = 0.71; 95% CI 0.66 to 0.76) and predicted risk of significant hyperbilirubinaemia as high as 59% compared with a maximum of 44% for the clinical risk factor score. Neither the risk score nor the pre-discharge TSB risk zone predicted the outcome with > or =0.98 sensitivity without significantly compromising specificity (0.13 and 0.21, respectively). Multi-level clinical risk factor scores and TSB risk zones produced likelihood ratios of 0.15-3.25 and 0.05-9.43, respectively. CONCLUSIONS: The pre-discharge bilirubin expressed as a risk zone on an hour specific bilirubin nomogram is more accurate and generates wider risk stratification than a clinical risk factor score.