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1.  A descriptive analysis of child-relevant systematic reviews in the Cochrane Database of Systematic Reviews 
BMC Pediatrics  2010;10:34.
Systematic reviews (SRs) are considered an important tool for decision-making. There has been no recent comprehensive identification or description of child-relevant SRs. A description of existing child-relevant SRs would help to identify the extent of available child-relevant evidence available in SRs and gaps in the evidence base where SRs are required. The objective of this study was to describe child-relevant SRs from the Cochrane Database of Systematic Reviews (CDSR, Issue 2, 2009).
SRs were assessed for relevance using pre-defined criteria. Data were extracted and entered into an electronic form. Univariate analyses were performed to describe the SRs overall and by topic area.
The search yielded 1666 SRs; 793 met the inclusion criteria. 38% of SRs were last assessed as up-to-date prior to 2007. Corresponding authors were most often from the UK (41%). Most SRs (59%) examined pharmacological interventions. 53% had at least one external source of funding. SRs included a median of 7 studies (IQR 3, 15) and 679 participants (IQR 179, 2833). Of all studies, 48% included only children, and 27% only adults. 94% of studies were published in peer-reviewed journals. Primary outcomes were specified in 72% of SRs. Allocation concealment and the Jadad scale were used in 97% and 25% of SRs, respectively. Adults and children were analyzed separately in 12% of SRs and as a subgroup analysis in 14%. Publication bias was assessed in only 14% of SRs. A meta-analysis was conducted in 68% of SRs with a median of 5 trials (IQR 3, 9) each. Variations in these characteristics were observed across topic areas.
We described the methodological characteristics and rigour of child-relevant reviews in the CDSR. Many SRs are not up-to-date according to Cochrane criteria. Our study describes variation in conduct and reporting across SRs and reveals clinicians' ability to access child-specific data.
PMCID: PMC2881081  PMID: 20487565
2.  Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial 
BMC Pediatrics  2008;8:4.
Anorexia Nervosa (AN) is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN.
Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type) or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen) for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited over two years to complete enrollment.
Randomized controlled trials designed to measure the safety and effectiveness of olanzapine in comparison to placebo are desperately needed, particularly in the adolescent population.
Trial registration
Current Controlled Trials ISRCTN23032339
PMCID: PMC2258294  PMID: 18234120
3.  How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial 
BMC Pediatrics  2007;7:7.
Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture.
Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test.
One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed.
Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.
PMCID: PMC1800845  PMID: 17288611
4.  Effect of point of care information on inpatient management of bronchiolitis 
BMC Pediatrics  2007;7:4.
We studied the effects of access to point-of-care medical evidence in a computerised physician order entry system (CPOE) on management and clinical outcome of children with bronchiolitis.
This was a before-after study that took place in a Canadian tertiary care paediatric teaching hospital. The intervention was a clinical evidence module (CEM) for bronchiolitis management, adapted from Clinical Evidence (BMJ Publishing Group) and integrated into the hospital CPOE. CPOE users were medical trainees under the supervision of staff physicians working in the infant ward. Use of antibiotics, bronchodilators and corticosteroids; disease severity; length of hospital admission; and trainee use and perception of the CEM were measured before and after CEM introduction.
334 paediatric inpatients age 2 weeks to 2 years, with a clinical diagnosis of bronchiolitis; 147 children the year preceding and 187 children the year following introduction of a Clinical Evidence Module (CEM). The percentage of patients receiving antibiotics fell from 35% to 22% (relative decrease 37%) following the introduction of the CEM (p = 0.016). Bronchodilator use was high but following the CEM patients no longer received more than one variety. Steroid usage and length of hospitalisation were low and unaffected. Trainees found the CEM to be educational.
Readily accessible clinical evidence at the point of care was associated with a significant decrease in antibiotic use and an end to multiple bronchodilator use. The majority of physician trainees found the CEM to be a useful educational tool.
PMCID: PMC1794224  PMID: 17250764
5.  Randomized controlled trials in pediatric complementary and alternative medicine: Where can they be found? 
BMC Pediatrics  2003;3:1.
The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM).
Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews.
We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs.
Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection.
PMCID: PMC151673  PMID: 12589711
alternative medicine; bibliometrics; information services; medical informatics applications; pediatrics, evidence-based medicine
6.  Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine 
BMC Pediatrics  2002;2:3.
To examine the quality of reports of complementary and alternative medicine (CAM) systematic reviews in the pediatric population. We also examined whether there were differences in the quality of reports of a subset of CAM reviews compared to reviews using conventional interventions.
We assessed the quality of reports of 47 CAM systematic reviews and 19 reviews evaluating a conventional intervention. The quality of each report was assessed using a validated 10-point scale.
Authors were particularly good at reporting: eligibility criteria for including primary studies, combining the primary studies for quantitative analysis appropriately, and basing their conclusions on the data included in the review. Reviewers were weak in reporting: how they avoided bias in the selection of primary studies, and how they evaluated the validity of the primary studies. Overall the reports achieved 43% (median = 3) of their maximum possible total score. The overall quality of reporting was similar for CAM reviews and conventional therapy ones.
Evidence based health care continues to make important contributions to the well being of children. To ensure the pediatric community can maximize the potential use of these interventions, it is important to ensure that systematic reviews are conducted and reported at the highest possible quality. Such reviews will be of benefit to a broad spectrum of interested stakeholders.
PMCID: PMC99047  PMID: 11914146
7.  Assessing the quality of reports of randomized trials in pediatric complementary and alternative medicine 
BMC Pediatrics  2002;2:2.
To evaluate the quality of reports of complementary and alternative medicine (CAM) randomized controlled trials (RCTs) in the pediatric population. We also examined whether there was a change in the quality of reporting over time.
We used a systematic sample of 251 reports of RCTs that used a CAM intervention. The quality of each report was assessed using the number of CONSORT checklist items included, the frequency of unclear allocation concealment, and a 5-point quality assessment instrument.
Nearly half (40%) of the CONSORT checklist items were included in the reports, with an increase in the number of items included. The majority (81.3%) of RCTs reported unclear allocation concealment with no significant change over time. The quality of reports achieved approximately 40% of their maximum possible total score as assessed with the Jadad scale with no change over time. Information regarding adverse events was reported in less than one quarter of the RCTs (22%) and information regarding costs was mentioned in only a minority of reports (4%).
RCTs are an important tool for evidence based health care decisions. If these studies are to be relevant in the evaluation of CAM interventions it is important that they are conducted and reported with the highest possible standards. There is a need to redouble efforts to ensure that children and their families are participating in RCTs that are conducted and reported with minimal bias. Such studies will increase their usefulness to a board spectrum of interested stakeholders.
PMCID: PMC99046  PMID: 11914145

Results 1-7 (7)