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Lisa Hartling

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Lisa Hartling

Alberta Research Centre for Health Evidence (ARCHE)

Subject areas and related deposits

  • Acute Disease

  • Adolescents

    • Risk factors for methamphetamine use in youth: a systematic review.

      Background: Methamphetamine (MA) is a potent stimulant that is readily available. Its effects are similar to cocaine, but the drug has a profile associated with increased acute and chronic toxicities. The objective of this systematic review was to identify and synthesize literature on risk factors that are associated with MA use among youth. More than 40 electronic databases, websites, and key journals/meeting abstracts were searched. We included studies that compared children and adolescents (<= 18 years) who used MA to those who did not. One reviewer extracted the data and a second checked for completeness and accuracy. For discrete risk factors, odds ratios (OR) were calculated and when appropriate, a pooled OR with 95% confidence intervals (95% CI) was calculated. For continuous risk factors, mean difference and 95% CI were calculated and when appropriate, a weighted mean difference (WMD) and 95% CI was calculated. Results were presented separately by comparison group: low-risk (no previous drug abuse) and high-risk children (reported previous drug abuse or were recruited from a juvenile detention center). Results: Twelve studies were included. Among low-risk youth, factors associated with MA use were: history of heroin/opiate use (OR = 29.3; 95% CI: 9.8-87.8), family history of drug use (OR = 4.7; 95% CI: 2.8-7.9), risky sexual behavior (OR = 2.79; 95% CI: 2.25, 3.46) and some psychiatric disorders. History of alcohol use and smoking were also significantly associated with MA use. Among high-risk youth, factors associated with MA use were: family history of crime (OR = 2.0; 95% CI: 1.2-3.3), family history of drug use (OR = 4.7; 95% CI: 2.8-7.9), family history of alcohol abuse (OR = 3.2; 95% CI: 1.8-5.6), and psychiatric treatment (OR = 6.8; 95% CI: 3.6-12.9). Female sex was also significantly associated with MA use. Conclusion: Among low-risk youth, a history of engaging in a variety of risky behaviors was significantly associated with MA use. A history of a psychiatric disorder was a risk factor for MA for both low- and high-risk youth. Family environment was also associated with MA use. Many of the included studies were cross-sectional making it difficult to assess causation. Future research should utilize prospective study designs so that temporal relationships between risk factors and MA use can be established.

  • Asthma

    • Applying the risk of bias tool in a systematic review of combination long-acting beta-agonists and inhaled corticosteroids for persistent asthma.

      Background The Risk of Bias (RoB) tool is used to assess internal validity of randomized controlled trials (RCTs). Our objectives were to: 1) evaluate inter-rater agreement of the RoB tool; 2) determine the time to access supplemental study information; 3) compare the RoB tool with the Jadad scale and Schulz allocation concealment (AC); and 4) examine the relationship between RoB and effect estimates. Methods We conducted a systematic review of long-acting beta agonists (LABA) combined with inhaled corticosteroids (ICS) for adults with persistent asthma. Two reviewers independently assessed 107 trials using RoB, Jadad, and AC. One reviewer searched for study protocols. We assessed inter-rater agreement using weighted Kappa (κ) and the correlation between tools using Kendall's Tau (τ). Mean differences in effect sizes for RCTs with different RoB were calculated using inverse variance method and random effects model. Results Trials had good Jadad scores (median 4, IQR 3-4); however, 85% had unclear AC and 87% high RoB. The factor that most influenced RoB was the potential inappropriate influence of study sponsors (95% industry funded). Agreement on RoB domains was fair (κ = 0.40) to almost perfect (κ = 0.86), and moderate for overall RoB (κ = 0.41). Median time to complete RoB assessments was 21 minutes (IQR 14-27) and 12 minutes (IQR 9-16) to search for protocols. Protocols were identified for 5/42 studies (12%); in 3 cases the assessment of selective outcome reporting changed. There was low correlation between overall RoB vs. Jadad (τ = 0.04, p = 0.3) and AC (τ = −0.02, p = 0.7). Analyses comparing effect estimates and risk showed no important patterns. Conclusions Inter-rater agreement on RoB assessments was better than previously reported suggesting that review-specific guidelines are important. The correlation between RoB and Jadad was low suggesting measurement of different constructs (risk of bias vs. quality of reporting). The extensive involvement of the pharmaceutical industry in this LABA/ICS research should raise concerns about potential overestimates of treatment effects.

  • Automobile Driving

  • Breathing exercises

    • Clinical trials of meditation practices in health care: characteristics and quality.

      OBJECTIVE: To provide a descriptive overview of the clinical trials assessing meditation practices for health care. DESIGN: Systematic review of the literature. Comprehensive searches were conducted in 17 electronic bibliographic databases through September 2005. Other sources of potentially relevant studies included hand searches, reference tracking, contacting experts, and gray literature searches. Included studies were clinical trials with 10 or more adult participants using any meditation practice, providing quantitative data on health-related outcomes, and published in English. Two independent reviewers assessed study relevance, extracted the data, and assessed the methodological quality of the studies. RESULTS: Four hundred clinical trials on meditation (72% described as randomized) were included in the review (publication years 1956-2005). Five broad categories of meditation practices were identified: mantra meditation, mindfulness meditation, yoga, t'ai chi, and qigong. The three most studied clinical conditions were hypertension, miscellaneous cardiovascular diseases, and substance abuse. Psychosocial measures were the most frequently reported outcomes. Outcome measures of psychiatric and psychological symptoms dominate the outcomes of interest. Overall, the methodological quality of clinical trials is poor, but has significantly improved over time by 0.014 points every year (95% CI, 0.005, 0.023). CONCLUSIONS: Most clinical trials on meditation practices are generally characterized by poor methodological quality with significant threats to validity in every major quality domain assessed. Despite a statistically significant improvement in the methodological quality over time, it is imperative that future trials on meditation be rigorous in design, execution, analysis, and the reporting of results.

  • Bronchiolitis

    • Epinephrine for bronchiolitis

      Background: Bronchodilators are commonly used for acute bronchiolitis, despite uncertain effectiveness. Objectives: To examine the efficacy and safety of epinephrine in children less than two with acute viral bronchiolitis. Search methods: We searched CENTRAL (2010, Issue 3) which contains the Acute Respiratory Infections Group's Specialized Register, MEDLINE (1950 to September Week 2, 2010), EMBASE (1980 to September 2010), Scopus (1823 to September 2010), PubMed (March 2010), LILACS (1985 to September 2010) and Iran MedEx (1998 to September 2010). Selection criteria: We included randomized controlled trials comparing epinephrine to placebo or another intervention involving children less than two years with acute viral bronchiolitis. Studies were included if the trials presented data for at least one quantitative outcome of interest. We selected primary outcomes a priori, based on clinical relevance: rate of admission by days one and seven of presentation for outpatients, and length of stay (LOS) for inpatients. Secondary outcomes included clinical severity scores, pulmonary function, symptoms, quality of life and adverse events. Data collection and analysis: Two review authors independently screened the searches, applied inclusion criteria, assessed risk of bias and graded the evidence. We conducted separate analyses for different comparison groups (placebo, non-epinephrine bronchodilators, glucocorticoids) and for clinical setting (inpatient, outpatient). Main results: We included 19 studies (2256 participants). Epinephrine versus placebo among outpatients showed a significant reduction in admissions at Day 1 (risk ratio (RR) 0.67; 95% confidence interval (CI) 0.50 to 0.89) but not at Day 7 post-emergency department visit. There was no difference in LOS for inpatients. Epinephrine versus salbutamol showed no differences among outpatients for admissions at Day 1 or 7. Inpatients receiving epinephrine had a significantly shorter LOS compared to salbutamol (mean difference -0.28; 95% CI -0.46 to -0.09). One large RCT showed a significantly shorter admission rate at Day 7 for epinephrine and steroid combined versus placebo (RR 0.65; 95% CI 0.44 to 0.95). There were no important differences in adverse events. Authors' conclusions: This review demonstrates the superiority of epinephrine compared to placebo for short-term outcomes for outpatients, particularly in the first 24 hours of care. Exploratory evidence from a single study suggests benefits of epinephrine and steroid combined for later time points. More research is required to confirm the benefits of combined epinephrine and steroids among outpatients. There is no evidence of effectiveness for repeated dose or prolonged use of epinephrine or epinephrine and dexamethasone combined among inpatients.

    • From the trenches: a cross-sectional study applying the GRADE tool in systematic reviews of healthcare interventions.

      Background GRADE was developed to address shortcomings of tools to rate the quality of a body of evidence. While much has been published about GRADE, there are few empirical and systematic evaluations. Objective To assess GRADE for systematic reviews (SRs) in terms of inter-rater agreement and identify areas of uncertainty. Design Cross-sectional, descriptive study. Methods We applied GRADE to three SRs (n = 48, 66, and 75 studies, respectively) with 29 comparisons and 12 outcomes overall. Two reviewers graded evidence independently for outcomes deemed clinically important a priori. Inter-rater reliability was assessed using kappas for four main domains (risk of bias, consistency, directness, and precision) and overall quality of evidence. Results For the first review, reliability was: κ = 0.41 for risk of bias; 0.84 consistency; 0.18 precision; and 0.44 overall quality. Kappa could not be calculated for directness as one rater assessed all items as direct; assessors agreed in 41% of cases. For the second review reliability was: 0.37 consistency and 0.19 precision. Kappa could not be assessed for other items; assessors agreed in 33% of cases for risk of bias; 100% directness; and 58% overall quality. For the third review, reliability was: 0.06 risk of bias; 0.79 consistency; 0.21 precision; and 0.18 overall quality. Assessors agreed in 100% of cases for directness. Precision created the most uncertainty due to difficulties in identifying “optimal” information size and “clinical decision threshold”, as well as making assessments when there was no meta-analysis. The risk of bias domain created uncertainty, particularly for nonrandomized studies. Conclusions As researchers with varied levels of training and experience use GRADE, there is risk for variability in interpretation and application. This study shows variable agreement across the GRADE domains, reflecting areas where further guidance is required.

    • Glucocorticoids for acute viral bronchiolitis in infants and young children

      BACKGROUND: Previous systematic reviews have not shown clear benefit of glucocorticoids for acute viral bronchiolitis, but their use remains considerable. Recent large trials add substantially to current evidence and suggest novel glucocorticoid-including treatment approaches. OBJECTIVES: To review the efficacy and safety of systemic and inhaled glucocorticoids in children with acute viral bronchiolitis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, issue 4); MEDLINE (1950 to November 2009); EMBASE (1980 to Week 47 2009); LILACS (1982 to November 2009); Scopus® (1823 to November 2009); and IRAN MedEx (1998 to November 2009). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing short-term systemic or inhaled glucocorticoids versus placebo or another intervention in children < 24 months with acute bronchiolitis (first episode with wheezing). Our primary outcomes were: admissions by days 1 and 7 for outpatient studies; and length of stay (LOS) for inpatient studies. Secondary outcomes included clinical severity parameters, healthcare use, pulmonary function, symptoms, quality of life and harms. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data on study and participant characteristics, interventions and outcomes. We assessed risk of bias and graded strength of evidence. Inpatient and outpatient results were meta-analysed separately using random-effects models. We pre-specified subgroup analyses, including the combined use of protocolised bronchodilators. MAIN RESULTS: We included 17 trials (2596 participants); only two had low overall risk of bias. Baseline severity, glucocorticoid schemes, comparators and outcomes were heterogeneous. Glucocorticoids did not significantly reduce outpatient admissions by days 1 and 7 when compared to placebo (pooled risk ratios (RRs) 0.92; 95% CI 0.78 to 1.08; and 0.86; 95% CI 0.7 to 1.06, respectively). There was no benefit in LOS for inpatients (mean difference -0.18 days; 95% CI -0.39 to 0.04). Unadjusted results from a large factorial low risk of bias RCT found combined high-dose systemic dexamethasone and inhaled epinephrine reduced admissions by day 7 (baseline risk of admission 26%; RR 0.65, 95% CI 0.44 to 0.95; number needed to treat 11, 95% CI 7 to 76), with no differences in short-term adverse effects. No other comparisons showed relevant differences in primary outcomes. AUTHORS' CONCLUSIONS: Current evidence does not support a clinically relevant effect of systemic or inhaled glucocorticoids on admissions or length of hospitalization. Combined dexamethasone and epinephrine may reduce outpatient admissions, but results are exploratory and safety data limited. Future research should further assess the efficacy, harms and applicability of combined therapy.

  • Cardiology

    • A systematic review of intravenous gamma globulin for therapy of acute myocarditis.

      Background: Intravenous gamma globulin (IVGG) is commonly used in the management of acute myocarditis. The objective of this study was to systematically review the literature evaluating this practice. Methods: We conducted a comprehensive search (electronic databases, trials registries, conference proceedings, reference lists, contact with authors) to identify studies evaluating the use of IVGG in adults and children with a clinical or histologically proven diagnosis of myocarditis of possible viral etiology and symptoms of less than six months duration. Two reviewers independently screened the searches, applied inclusion criteria, and graded the evidence. Results: Results were described qualitatively; data were not pooled because only one randomized controlled trial (RCT) with 62 patients was identified. The RCT showed no benefit with respect to cardiac function, functional outcome, or event-free survival. A small, uncontrolled trial (n = 10) showed significant improvement in LVEF from a mean of 24% to 41% 12 months after IVGG in nine survivors. A retrospective cohort study of pediatric patients showed improvement in cardiac function and a trend towards improved survival in patients receiving IVGG (n = 21) versus historic controls (n = 25). Ten case reports and two case series (total n = 21) described improvement in cardiac function after administration of IVGG; two case reports showed no benefit of IVGG. One case of hemolytic anemia was attributed to IVGG. Conclusion: There is insufficient data from methodologically strong studies to recommend routine use of IVGG for acute myocarditis. Future randomized studies that take into account the etiology of acute myocarditis will be required to determine the efficacy of IVGG.

  • Chickenpox

    • Acyclovir for treating varicella in otherwise healthy children and adolescents: a systematic review of randomised controlled trials.

      Background Acyclovir has the potential to shorten the course of chickenpox which may result in reduced costs and morbidity. We conducted a systematic review of randomised controlled trials that evaluated acyclovir for the treatment of chickenpox in otherwise healthy children. Methods MEDLINE, EMBASE, and the Cochrane Library were searched. The reference lists of relevant articles were examined and primary authors and Glaxo Wellcome were contacted to identify additional trials. Two reviewers independently screened studies for inclusion, assessed study quality using the Jadad scale and allocation concealment, and extracted data. Continuous data were converted to a weighted mean difference (WMD). Overall estimates were not calculated due to differences in the age groups studied. Results Three studies were included. Methodological quality was 3 (n = 2) and 4 (n = 1) on the Jadad scale. Acyclovir was associated with a significant reduction in the number of days with fever, from -1.0 (95% CI -1.5,-0.5) to -1.3 (95% CI -2.0,-0.6). Results were inconsistent with respect to the number of days to no new lesions, the maximum number of lesions and relief of pruritis. There were no clinically important differences between acyclovir and placebo with respect to complications or adverse effects. Conclusion Acyclovir appears to be effective in reducing the number of days with fever among otherwise healthy children with chickenpox. The results were inconsistent with respect to the number of days to no new lesions, the maximum number of lesions and the relief of itchiness. The clinical importance of acyclovir treatment in otherwise healthy children remains controversial.

  • Child health

    • Children are not just small adults: the urgent need for high-quality trial evidence in children.

      Children are often touted as being very important members of society because they represent our future. Optimizing their health outcomes has the potential for a huge impact on public health because children are at an early stage in the life trajectory. But it is often unclear how society allocates its resources or creates policies to ensure that it invests in children's health. The under-investment in pediatric clinical trials is a good example of how our resource allocation may be insufficient. Over half of the pharmacological interventions we use for hospitalized children are off-label or unlicensed drugs [1,2]. The challenge for clinical care is that health care providers may fail to use medications that are indeed effective, or conversely, continue to use ineffective medications, or even those that bring unintended harm. Child health care providers must often rely on evidence that has been generated on adult populations [3]. However, both the safety and efficacy profiles of medications may be significantly different for children than adults due to differences in developmental physiology, disease pathophysiology, or developmental pharmacokinetics and pharmacodynamics

    • Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

      Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

    • A descriptive analysis of overviews of reviews published between 2000 and 2011.

      Background: Overviews of systematic reviews compile data from multiple systematic reviews (SRs) and are a new method of evidence synthesis. Objectives: To describe the methodological approaches in overviews of interventions. Design: Descriptive study. Methods: We searched 4 databases from 2000 to July 2011; we handsearched Evidence-based Child Health: A Cochrane Review Journal. We defined an overview as a study that: stated a clear objective; examined an intervention; used explicit methods to identify SRs; collected and synthesized outcome data from the SRs; and intended to include only SRs. We did not restrict inclusion by population characteristics (e.g., adult or children only). Two researchers independently screened studies and applied eligibility criteria. One researcher extracted data with verification by a second. We conducted a descriptive analysis. Results: From 2,245 citations, 75 overviews were included. The number of overviews increased from 1 in 2000 to 14 in 2010. The interventions were pharmacological (n = 20, 26.7%), non-pharmacological (n = 26, 34.7%), or both (n = 29, 38.7%). Inclusion criteria were clearly stated in 65 overviews. Thirty-three (44%) overviews searched at least 2 databases. The majority reported the years and databases searched (n = 46, 61%), and provided key words (n = 58, 77%). Thirty-nine (52%) overviews included Cochrane SRs only. Two reviewers independently screened and completed full text review in 29 overviews (39%). Methods of data extraction were reported in 45 (60%). Information on quality of individual studies was extracted from the original SRs in 27 (36%) overviews. Quality assessment of the SRs was performed in 28 (37%) overviews; at least 9 different tools were used. Quality of the body of evidence was assessed in 13 (17%) overviews. Most overviews provided a narrative or descriptive analysis of the included SRs. One overview conducted indirect analyses and the other conducted mixed treatment comparisons. Publication bias was discussed in 18 (24%) overviews. Conclusions: This study shows considerable variation in the methods used for overviews. There is a need for methodological rigor and consistency in overviews, as well as empirical evidence to support the methods employed.

    • Quantifying bias in randomized controlled trials in child health: a meta-epidemiological study.

      Objective: To quantify bias related to specific methodological characteristics in child-relevant randomized controlled trials (RCTs). Design: Meta-epidemiological study. Data Sources: We identified systematic reviews containing a meta-analysis with 10–40 RCTs that were relevant to child health in the Cochrane Database of Systematic Reviews. Data Extraction: Two reviewers independently assessed RCTs using items in the Cochrane Risk of Bias tool and other study factors. We used meta-epidemiological methods to assess for differences in effect estimates between studies classified as high/unclear vs. low risk of bias. Results: We included 287 RCTs from 17 meta-analyses. The proportion of studies at high/unclear risk of bias was: 79% sequence generation, 83% allocation concealment, 67% blinding of participants, 47% blinding of outcome assessment, 49% incomplete outcome data, 32% selective outcome reporting, 44% other sources of bias, 97% overall risk of bias, 56% funding, 35% baseline imbalance, 13% blocked randomization in unblinded trials, and 1% early stopping for benefit. We found no significant differences in effect estimates for studies that were high/unclear vs. low risk of bias for any of the risk of bias domains, overall risk of bias, or other study factors. Conclusions: We found no differences in effect estimates between studies based on risk of bias. A potential explanation is the number of trials included, in particular the small number of studies with low risk of bias. Until further evidence is available, reviewers should not exclude RCTs from systematic reviews and meta-analyses based solely on risk of bias particularly in the area of child health.

    • A Randomized Controlled Trial of Storytelling as a Communication Tool.

      Introduction Stories may be an effective tool to communicate with patients because of their ability to engage the reader. Our objective was to evaluate the effectiveness of story booklets compared to standard information sheets for parents of children attending the emergency department (ED) with a child with croup. Methods Parents were randomized to receive story booklets (n=208) or standard information sheets (n=205) during their ED visit. The primary outcome was change in anxiety between triage to ED discharge as measured by the State-Trait Anxiety Inventory. Follow-up telephone interviews were conducted at 1 and 3 days after discharge, then every other day until 9 days (or until resolution of symptoms), and at 1 year. Secondary outcomes included: expected future anxiety, event impact, parental knowledge, satisfaction, decision regret, healthcare utilization, time to symptom resolution. Results There was no significant difference in the primary outcome of change in parental anxiety between recruitment and ED discharge (change of 5 points for the story group vs. 6 points for the comparison group, p=0.78). The story group showed significantly greater decision regret regarding their decision to go to the ED (p<0.001): 6.7% of the story group vs. 1.5% of the comparison group strongly disagreed with the statement “I would go for the same choice if I had to do it over again”. The story group reported shorter time to resolution of symptoms (mean 3.7 days story group vs. 4.0 days comparison group, median 3 days both groups; log rank test, p=0.04). No other outcomes were different between study groups. Conclusions Stories about parent experiences managing a child with croup did not reduce parental anxiety. The story group showed significantly greater decision regret and quicker time to resolution of symptoms. Further research is needed to better understand whether stories can be effective in improving patient-important outcomes.

  • Critical Ilness

    • Nutritional support for critically ill children

      Background: Nutritional support in the critically ill child has not been well investigated and is a controversial topic within paediatric intensive care. There are no clear guidelines as to the best form or timing of nutrition in critically ill infants and children. Objectives: To assess the impact of enteral and total parenteral nutrition on clinically important outcomes for critically ill children. Search methods: We searched: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 1); Ovid MEDLINE (1966 to February 2007); Ovid EMBASE (1988 to February 2007); OVID Evidence-Based Medicine Reviews; ISI Web of Science - Science Citation Index Expanded (1965 to February 2007); WebSPIRS Biological Abstracts (1969 to February 2007); and WebSPIRS CAB Abstracts (1972 to February 2007). We also searched trial registries; reviewed reference lists of all potentially relevant studies; handsearched relevant conference proceedings; and contacted experts in the area and manufacturers of enteral and parenteral nutrition products. We did not limit the search by language or publication status. Selection criteria: We included studies if they were randomized controlled trials; involved paediatric patients, aged one day to 18 years of age, cared for in a paediatric intensive care unit setting (PICU) and received nutrition within the first seven days of admission; and reported data for at least one of the pre-specified outcomes (30-day or PICU mortality; length of stay in PICU or hospital; number of ventilator days; and morbid complications, such as nosocomial infections). We excluded studies if they only reported nutritional outcomes, quality of life assessments, or economic implications. Furthermore, other areas of paediatric nutrition, such as immunonutrition and different routes of delivering enteral nutrition, were not addressed in this review. Data collection and analysis: Two authors independently screened searches, applied inclusion criteria, and performed quality assessments. We resolved discrepancies through discussion and consensus. One author extracted data and a second checked data for accuracy and completeness. Main results: Only one trial was identified as relevant. Seventy-seven children in intensive care with burns involving > 25% of the total body surface area were randomized to either enteral nutrition within 24 hours or after at least 48 hours. No statistically significant differences were observed for mortality, sepsis, ventilator days, length of stay, unexpected adverse events, resting energy expenditure, nitrogen balance, or albumin levels. The trial was assessed as of low methodological quality (based on the Jadad scale) with an unclear risk of bias. Authors' conclusions: There was only one randomized trial relevant to the review question. Research is urgently needed to identify best practices regarding the timing and forms of nutrition for critically ill infants and children.

  • Dehydration in children

    • Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials.

      Background Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. Methods RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. Results The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. Conclusion There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis.

  • Emergency medical services

    • Treatment in the pediatric emergency department is evidence based: a retrospective analysis.

      Background Our goal was to quantify the evidence that is available to the physicians of a pediatric emergency department (PED) in making treatment decisions. Further, we wished to ascertain what percentage of evidence for treatment provided in the PED comes from pediatric studies. Methods We conducted a retrospective chart review of randomly selected patients seen in the PED between January 1 and December 31, 2002. The principal investigator identified a primary diagnosis and primary intervention for each chart. A thorough literature search was then undertaken with respect to the primary intervention. If a randomized control trial (RCT) or a systematic review was found, the intervention was classified as level I evidence. If no RCT was found, the intervention was assessed by an expert committee who determined its appropriateness based on face validity (RCTs were unanimously judged to be both unnecessary and, if a placebo would have been involved, unethical). These interventions were classified as level II evidence. Interventions that did not fall into either above category were classified as level III evidence. Results Two hundred and sixty-two patient charts were reviewed. Of these, 35.9% did not receive a primary intervention. Of the 168 interventions assessed, 80.4% were evidence-based (level I), 7.1% had face validity (level II) and 12.5% had no supporting evidence (level III). Of the evidence-based interventions, 83.7% were supported by studies with mostly pediatric patients. Conclusion Our study demonstrates that a substantial proportion of PED treatment decisions are evidence-based, with most based on studies in pediatric patients. Also, a large number of patients seen in the PED receive no intervention.

  • Infants

    • Steroids and bronchodilators for acute bronchiolitis in the first two years of life: systematic review and meta-analysis.

      Objective To evaluate and compare the efficacy and safety of bronchodilators and steroids, alone or combined, for the acute management of bronchiolitis in children aged less than 2 years. Design Systematic review and meta-analysis. Data sources Medline, Embase, Central, Scopus, PubMed, LILACS, IranMedEx, conference proceedings, and trial registers. Inclusion criteria Randomised controlled trials of children aged 24 months or less with a first episode of bronchiolitis with wheezing comparing any bronchodilator or steroid, alone or combined, with placebo or another intervention (other bronchodilator, other steroid, standard care). Review methods Two reviewers assessed studies for inclusion and risk of bias and extracted data. Primary outcomes were selected by clinicians a priori based on clinical relevance: rate of admission for outpatients (day 1 and up to day 7) and length of stay for inpatients. Direct meta-analyses were carried out using random effects models. A mixed treatment comparison using a Bayesian network model was used to compare all interventions simultaneously. Results 48 trials (4897 patients, 13 comparisons) were included. Risk of bias was low in 17% (n=8), unclear in 52% (n=25), and high in 31% (n=15). Only adrenaline (epinephrine) reduced admissions on day 1 (compared with placebo: pooled risk ratio 0.67, 95% confidence interval 0.50 to 0.89; number needed to treat 15, 95% confidence interval 10 to 45 for a baseline risk of 20%; 920 patients). Unadjusted results from a single large trial with low risk of bias showed that combined dexamethasone and adrenaline reduced admissions on day 7 (risk ratio 0.65, 0.44 to 0.95; number needed to treat 11, 7 to 76 for a baseline risk of 26%; 400 patients). A mixed treatment comparison supported adrenaline alone or combined with steroids as the preferred treatments for outpatients (probability of being the best treatment based on admissions at day 1 were 45% and 39%, respectively). The incidence of reported harms did not differ. None of the interventions examined showed clear efficacy for length of stay among inpatients. Conclusions Evidence shows the effectiveness and superiority of adrenaline for outcomes of most clinical relevance among outpatients with acute bronchiolitis, and evidence from a single precise trial for combined adrenaline and dexamethasone.

  • Lacerations

  • Melatonin

    • Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis.

      Objective To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. Data sources 13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003). Study selection The efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials. Quality assessment Randomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist. Data extraction and synthesis One reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data. Main results Six randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference −13.2 (95% confidence interval −27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (−1.0 (−2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less). Conclusions There is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.

  • Pediatrics

    • Children in reviews: methodological issues in child-relevant evidence syntheses.

      Background The delivery of optimal medical care to children is dependent on the availability of child relevant research. Our objectives were to: i) systematically review and describe how children are handled in reviews of drug interventions published in the Cochrane Database of Systematic Reviews (CDSR); and ii) determine when effect sizes for the same drug interventions differ between children and adults. Methods We systematically identified all of the reviews relevant to child health in the CDSR 2002, Issue 4. Reviews were included if they investigated the efficacy or effectiveness of a drug intervention for a condition that occurs in both children and adults. Information was extracted on review characteristics including study methods, results, and conclusions. Results From 1496 systematic reviews, 408 (27%) were identified as relevant to both adult and child health; 52% (213) of these included data from children. No significant differences were found in effect sizes between adults and children for any of the drug interventions or conditions investigated. However, all of the comparisons lacked the power to detect a clinically significant difference and wide confidence intervals suggest important differences cannot be excluded. A large amount of data was unavailable due to inadequate reporting at the trial and systematic review level. Conclusion Overall, the findings of this study indicate there is a paucity of child-relevant and specific evidence generated from evidence syntheses of drug interventions. The results indicate a need for a higher standard of reporting for participant populations in studies of drug interventions.

  • Poster - Canadian Cochrane Symposium 2008

  • Posters

  • Randomized controlled trials

    • Behavioural and developmental interventions for autism spectrum disorder: a clinical systematic review.

      BACKGROUND: Much controversy exists regarding the clinical efficacy of behavioural and developmental interventions for improving the core symptoms of autism spectrum disorders (ASD). We conducted a systematic review to summarize the evidence on the effectiveness of behavioural and developmental interventions for ASD. METHODS AND FINDINGS: Comprehensive searches were conducted in 22 electronic databases through May 2007. Further information was obtained through hand searching journals, searching reference lists, databases of theses and dissertations, and contacting experts in the field. Experimental and observational analytic studies were included if they were written in English and reported the efficacy of any behavioural or developmental intervention for individuals with ASD. Two independent reviewers made the final study selection, extracted data, and reached consensus on study quality. Results were summarized descriptively and, where possible, meta-analyses of the study results were conducted. One-hundred-and-one studies at predominantly high risk of bias that reported inconsistent results across various interventions were included in the review. Meta-analyses of three controlled clinical trials showed that Lovaas treatment was superior to special education on measures of adaptive behaviour, communication and interaction, comprehensive language, daily living skills, expressive language, overall intellectual functioning and socialization. High-intensity Lovaas was superior to low-intensity Lovaas on measures of intellectual functioning in two retrospective cohort studies. Pooling the results of two randomized controlled trials favoured developmental approaches based on initiative interaction compared to contingency interaction in the amount of time spent in stereotyped behaviours and distal social behaviour, but the effect sizes were not clinically significant. No statistically significant differences were found for: Lovaas versus special education for non-verbal intellectual functioning; Lovaas versus Developmental Individual-difference relationship-based intervention for communication skills; computer assisted instruction versus no treatment for facial expression recognition; and TEACCH versus standard care for imitation skills and eye-hand integration. CONCLUSIONS: While this review suggests that Lovaas may improve some core symptoms of ASD compared to special education, these findings are based on pooling of a few, methodologically weak studies with few participants and relatively short-term follow-up. As no definitive behavioural or developmental intervention improves all symptoms for all individuals with ASD, it is recommended that clinical management be guided by individual needs and availability of resources.

  • Randomized Controlled Trials as Topic

    • A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

      BACKGROUND: Randomized controlled trials (RCTs) are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. METHODS: We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. RESULTS: Most studies (83%) were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB) was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008). Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25). Among survey respondents (50% response rate), the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. CONCLUSIONS: More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

    • Risk of bias versus quality assessment of randomised controlled trials: cross sectional study.

      Objectives To evaluate the risk of bias tool, introduced by the Cochrane Collaboration for assessing the internal validity of randomised trials, for inter-rater agreement, concurrent validity compared with the Jadad scale and Schulz approach to allocation concealment, and the relation between risk of bias and effect estimates. Design Cross sectional study. Study sample 163 trials in children. Main outcome measures Inter-rater agreement between reviewers assessing trials using the risk of bias tool (weighted κ), time to apply the risk of bias tool compared with other approaches to quality assessment (paired t test), degree of correlation for overall risk compared with overall quality scores (Kendall’s τ statistic), and magnitude of effect estimates for studies classified as being at high, unclear, or low risk of bias (metaregression). Results Inter-rater agreement on individual domains of the risk of bias tool ranged from slight (κ=0.13) to substantial (κ=0.74). The mean time to complete the risk of bias tool was significantly longer than for the Jadad scale and Schulz approach, individually or combined (8.8 minutes (SD 2.2) per study v 2.0 (SD 0.8), P<0.001). There was low correlation between risk of bias overall compared with the Jadad scores (P=0.395) and Schulz approach (P=0.064). Effect sizes differed between studies assessed as being at high or unclear risk of bias (0.52) compared with those at low risk (0.23). Conclusions Inter-rater agreement varied across domains of the risk of bias tool. Generally, agreement was poorer for those items that required more judgment. There was low correlation between assessments of overall risk of bias and two common approaches to quality assessment: the Jadad scale and Schulz approach to allocation concealment. Overall risk of bias as assessed by the risk of bias tool differentiated effect estimates, with more conservative estimates for studies at low risk.

  • Safety

    • Best practices for safe handling of products containing concentrated potassium.

      Recommendations for improved patients’ safety, specifically the safety of products containing potassium, are often based on practice guidelines and untested recommendations widely endorsed by various experts or organisations Valid and empirical evidence to support or discourage implementation of even the most widely identified potassium safety practices is completely lacking Research aimed at evaluating healthcare systems as a whole, accompanied by implementation of effective evidence based medication safety practices, is essential and urgently needed

  • Storytelling

    • Storytelling as a communication tool for health consumers: development of an intervention for parents of children with croup. Stories to communicate health information.

      BACKGROUND: Stories may be an effective tool to communicate with and influence patients because of their ability to engage the reader. The objective of this paper is to describe the development of a story-based intervention for delivery of health evidence to parents of children with croup for use in a randomized controlled trial. METHODS: A creative writer interviewed parents of children with croup presenting to the pediatric emergency department (ED) and drafted stories. We revised the stories based on written participant feedback and edited the stories to incorporate research evidence and health information. An illustrator and graphic designer developed story booklets which were evaluated through focus groups. RESULTS: Ten participants provided feedback on the five stories drafted by the creative writer. Participants liked the concept but found the writing overly sophisticated and wanted more character development and more medical/health information. Participants highlighted specific story content that they liked and disliked. The revised stories were evaluated through focus groups involving eight individuals. Feedback was generally positive; one participant questioned the associated costs. Participants liked the graphics and layout; felt that they could identify with the stories; and felt that it was easier to get information compared to a standard medical information sheet. Participants provided feedback on the story content, errors and inconsistencies, and preferences of writing style and booklet format. Feedback on how to package the stories was provided by attendees at a national meeting of pediatric emergency researchers. CONCLUSIONS: Several challenges arose during the development of the stories including: staying true to the story versus being evidence based; addressing the use of the internet by consumers as a source of health information; balancing the need to be comprehensive and widely applicable while being succinct; considerations such as story length, reading level, narrative mode, representation of different demographics and illness experiences, graphics and layout. The process was greatly informed by feedback from the end-user group. This allowed us to shape our products to ensure accuracy, credibility, and relevance. Our experience is valuable for further work in the area of stories and narratives, as well as more broadly for identifying and developing communication strategies for healthcare consumers.

  • Storytelling, narrative, randomized controlled trial, croup, parent

  • Systematic Reviews as Topic

    • A descriptive analysis of child-relevant systematic reviews in the Cochrane Database of Systematic Reviews

      Background: 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).Methods: 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.Results: 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.Conclusions: 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.

  • Theory of medicine

    • Which resources should be used to identify RCT/CCTs for systematic reviews: a systematic review.

      Background Systematic reviewers seek to comprehensively search for relevant studies and summarize these to present the most valid estimate of intervention effectiveness. The more resources searched, the higher the yield, and thus time and costs required to conduct a systematic review. While there is an abundance of evidence to suggest how extensive a search for randomized controlled trials (RCTs) should be, it is neither conclusive nor consistent. This systematic review was conducted in order to assess the value of different resources to identify trials for inclusion in systematic reviews. Methods Seven electronic databases, four journals and Cochrane Colloquia were searched. Key authors were contacted and references of relevant articles screened. Included studies compared two or more sources to find RCTs or controlled clinical trials (CCTs). A checklist was developed and applied to assess quality of reporting. Data were extracted by one reviewer and checked by a second. Medians and ranges for precision and recall were calculated; results were grouped by comparison. Meta-analysis was not performed due to large heterogeneity. Subgroup analyses were conducted for: search strategy (Cochrane, Simple, Complex, Index), expertise of the searcher (Cochrane, librarian, non-librarian), and study design (RCT and CCT). Results Sixty-four studies representing 13 electronic databases met inclusion criteria. The most common comparisons were MEDLINE vs. handsearching (n = 23), MEDLINE vs. MEDLINE+handsearching (n = 13), and MEDLINE vs. reference standard (n = 13). Quality was low, particularly for the reporting of study selection methodology. Overall, recall and precision varied substantially by comparison and ranged from 0 to 100% and 0 to 99%, respectively. The trial registries performed the best with median recall of 89% (range 84, 95) and median precision of 96.5% (96, 97), although these results are based on a small number of studies. Inadequate or inappropriate indexing was the reason most cited for missing studies. Complex and Cochrane search strategies (SS) performed better than Simple SS. Conclusion Multiple-source comprehensive searches are necessary to identify all RCTs for a systematic review, although indexing needs to be improved. Although trial registries demonstrated the highest recall and precision, the Cochrane SS or a Complex SS in consultation with a librarian are recommended. Continued efforts to develop CENTRAL should be supported.

  • Weight loss program

    • Social media interventions for diet and exercise behaviours: a systematic review and meta-analysis of randomised controlled trials.

      Objectives To conduct a systematic review of randomised controlled trials (RCTs) examining the use of social media to promote healthy diet and exercise in the general population. Data sources MEDLINE, CENTRAL, ERIC, PubMed, CINAHL, Academic Search Complete, Alt Health Watch, Health Source, Communication and Mass Media Complete, Web of Knowledge and ProQuest Dissertation and Thesis (2000–2013). Study eligibility criteria RCTs of social media interventions promoting healthy diet and exercise behaviours in the general population were eligible. Interventions using social media, alone or as part of a complex intervention, were included. Study appraisal and synthesis Study quality was assessed using the Cochrane Risk of Bias Tool. We describe the studies according to the target populations, objectives and nature of interventions, outcomes examined, and results and conclusions. We extracted data on the primary and secondary outcomes examined in each study. Where the same outcome was assessed in at least three studies, we combined data in a meta-analysis. Results 22 studies were included. Participants were typically middle-aged Caucasian women of mid-to-high socioeconomic status. There were a variety of interventions, comparison groups and outcomes. All studies showed a decrease in programme usage throughout the intervention period. Overall, no significant differences were found for primary outcomes which varied across studies. Meta-analysis showed no significant differences in changes in physical activity (standardised mean difference (SMD) 0.13 (95% CI −0.04 to 0.30), 12 studies) and weight (SMD −0.00 (95% CI −0.19 to 0.19), 10 studies); however, pooled results from five studies showed a significant decrease in dietary fat consumption with social media (SMD −0.35 (95% CI −0.68 to −0.02)). Conclusions Social media may provide certain advantages for public health interventions; however, studies of social media interventions to date relating to healthy lifestyles tend to show low levels of participation and do not show significant differences between groups in key outcomes.