[show abstract][hide abstract] ABSTRACT: To quantify bias related to specific methodological characteristics in child-relevant randomized controlled trials (RCTs).
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.
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.
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.
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.
PLoS ONE 01/2014; 9(2):e88008. · 3.73 Impact Factor
[show abstract][hide abstract] ABSTRACT: 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.
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).
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 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.
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)).
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.
BMJ Open 01/2014; 4(2):e003926. · 1.58 Impact Factor
[show abstract][hide abstract] ABSTRACT: To conduct a scoping review of the literature on social media use by health care professionals and trainees.
The authors searched MEDLINE, CENTRAL, ERIC, PubMed, CINAHL Plus Full Text, Academic Search Complete, Alt Health Watch, Health Source, Communication and Mass Media Complete, Web of Knowledge, and ProQuest for studies published between 2000 and 2012. They included those reporting primary research on social media use by health care professionals or trainees. Two reviewers screened studies for eligibility; one reviewer extracted data and a second verified a 10% sample. They analyzed data descriptively to determine which social media tools were used, by whom, for what purposes, and how they were evaluated.
The authors included 96 studies in their review. Discussion forums were the most commonly studied tools (43/96; 44.8%). Researchers more often studied social media in educational than practice settings. Of common specialties, administration, critical appraisal, and research appeared most often (11/96; 11.5%), followed by public health (9/96; 9.4%). The objective of most tools was to facilitate communication (59/96; 61.5%) or improve knowledge (41/96; 42.7%). Thirteen studies evaluated effectiveness (13.5%), and 41 (42.7%) used a cross-sectional design.
These findings provide a map of the current literature on social media use in health care, identify gaps in that literature, and provide direction for future research. Social media use is widespread, particularly in education settings. The versatility of these tools suggests their suitability for use in a wide range of professional activities. Studies of their effectiveness could inform future practice.
Academic medicine: journal of the Association of American Medical Colleges 07/2013; · 2.34 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: To assess inter-rater reliability and validity of the Newcastle Ottawa Scale (NOS) used for methodological quality assessment of cohort studies included in systematic reviews. STUDY DESIGN AND SETTING: Two reviewers independently applied the NOS to 131 cohort studies included in eight meta-analyses. Inter-rater reliability was calculated using kappa (κ) statistics. To assess validity, within each meta-analysis, we generated a ratio of pooled estimates for each quality domain. Using a random-effects model, the ratios of odds ratios for each meta-analysis were combined to give an overall estimate of differences in effect estimates. RESULTS: Inter-rater reliability varied from substantial for length of follow-up (κ = 0.68, 95% confidence interval [CI] = 0.47, 0.89) to poor for selection of the nonexposed cohort and demonstration that the outcome was not present at the outset of the study (κ = -0.03, 95% CI = -0.06, 0.00; κ = -0.06, 95% CI = -0.20, 0.07). Reliability for overall score was fair (κ = 0.29, 95% CI = 0.10, 0.47). In general, reviewers found the tool difficult to use and the decision rules vague even with additional information provided as part of this study. We found no association between individual items or overall score and effect estimates. CONCLUSION: Variable agreement and lack of evidence that the NOS can identify studies with biased results underscore the need for revisions and more detailed guidance for systematic reviewers using the NOS.
Journal of clinical epidemiology 05/2013; · 2.96 Impact Factor
[show abstract][hide abstract] ABSTRACT: To map the state of the existing literature evaluating the use of social media in patient and caregiver populations.
Medline, CENTRAL, ERIC, PubMed, CINAHL Plus Full Text, Academic Search Complete, Alt Health Watch, Health Source, Communication and Mass Media Complete, Web of Knowledge and ProQuest (2000-2012).
Studies reporting primary research on the use of social media (collaborative projects, blogs/microblogs, content communities, social networking sites, virtual worlds) by patients or caregivers.
Two reviewers screened studies for eligibility; one reviewer extracted data from relevant studies and a second performed verification for accuracy and completeness on a 10% sample. Data were analysed to describe which social media tools are being used, by whom, for what purpose and how they are being evaluated.
Two hundred eighty-four studies were included. Discussion forums were highly prevalent and constitute 66.6% of the sample. Social networking sites (14.8%) and blogs/microblogs (14.1%) were the next most commonly used tools. The intended purpose of the tool was to facilitate self-care in 77.1% of studies. While there were clusters of studies that focused on similar conditions (eg, lifestyle/weight loss (12.7%), cancer (11.3%)), there were no patterns in the objectives or tools used. A large proportion of the studies were descriptive (42.3%); however, there were also 48 (16.9%) randomised controlled trials (RCTs). Among the RCTs, 35.4% reported statistically significant results favouring the social media intervention being evaluated; however, 72.9% presented positive conclusions regarding the use of social media.
There is an extensive body of literature examining the use of social media in patient and caregiver populations. Much of this work is descriptive; however, with such widespread use, evaluations of effectiveness are required. In studies that have examined effectiveness, positive conclusions are often reported, despite non-significant findings.
[show abstract][hide abstract] ABSTRACT: A research-practice gap exists between what is known about conducting methodologically rigorous randomized controlled trials (RCTs) and what is done. Evidence consistently shows that pediatric RCTs are susceptible to high risk of bias; therefore novel methods of influencing the design and conduct of trials are required. The objective of this study was to develop and pilot test a wiki designed to educate pediatric trialists and trainees in the principles involved in minimizing risk of bias in RCTs. The focus was on preliminary usability testing of the wiki.
The wiki was developed through adaptation of existing knowledge translation strategies and through tailoring the site to the identified needs of the end-users. The wiki was evaluated for usability and user preferences regarding the content and formatting. Semi-structured interviews were conducted with 15 trialists and systematic reviewers, representing varying levels of experience with risk of bias or the conduct of trials. Data were analyzed using content analysis.
Participants found the wiki to be well organized, easy to use, and straightforward to navigate. Suggestions for improvement tended to focus on clarification of the text or on esthetics, rather than on the content or format. Participants liked the additional features of the site that were supplementary to the text, such as the interactive examples, and the components that focused on practical applications, adding relevance to the theory presented. While the site could be used by both trialists and systematic reviewers, the lack of a clearly defined target audience caused some confusion among participants.
Participants were supportive of using a wiki as a novel educational tool. The results of this pilot test will be used to refine the risk of bias wiki, which holds promise as a knowledge translation intervention for education in medical research methodology.
PLoS ONE 01/2013; 8(5):e64922. · 3.73 Impact Factor
[show abstract][hide abstract] ABSTRACT: BACKGROUND: Pediatric randomized controlled trials (RCTs) are susceptible to a high risk of bias. We examined the barriers and facilitators that pediatric trialists face in the design and conduct of unbiased trials. METHODS: We used a mixed methods design, with semi-structured interviews building upon the results of a quantitative survey. We surveyed Canadian (n=253) and international (n=600) pediatric trialists regarding their knowledge and awareness of bias and their perceived barriers and facilitators in conducting clinical trials. We then interviewed 13 participants from different subspecialties and geographic locations to gain a more detailed description of how their experiences and attitudes towards research interacted with trial design and conduct. RESULTS: The survey response rate was 23.0% (186/807). 68.1% of respondents agreed that bias is a problem in pediatric RCTs and 72.0% felt that there is sufficient evidence to support changing some aspects of how trials are conducted. Knowledge related to bias was variable, with inconsistent awareness of study design features that may introduce bias into a study. Interview participants highlighted a lack of formal training in research methods, a negative research culture, and the pragmatics of trial conduct as barriers. Facilitators included contact with knowledgeable and supportive colleagues and infrastructure for research. CONCLUSIONS: A lack of awareness of bias and negative attitudes towards research present significant barriers in terms of conducting methodologically rigorous pediatric RCTs. Knowledge translation efforts must focus on these issues to ensure the relevance and validity of trial results.
BMC Medical Research Methodology 10/2012; 12(1):158. · 2.21 Impact Factor
[show abstract][hide abstract] ABSTRACT: OBJECTIVES: To assess the reliability of the Cochrane Risk of Bias (ROB) tool between individual raters and across consensus agreements of pairs of reviewers and examine the impact of study-level factors on reliability. STUDY DESIGN AND SETTING: Two reviewers assessed risk of bias for 154 randomized controlled trials (RCTs). For 30 RCTs, two reviewers from each of four centers assessed risk of bias and reached consensus. We assessed interrater agreement using kappas and the impact of study-level factors through subgroup analyses. RESULTS: Reliability between two reviewers was fair for most domains (κ=0.24-0.37), except sequence generation (κ=0.79, substantial). Reliability results across reviewer pairs: sequence generation, moderate (κ=0.60); allocation concealment and "other sources of bias," fair (κ=0.37-0.27); and other domains, slight (κ=0.05-0.09). Reliability was influenced by the nature of the outcome, nature of the intervention, study design, trial hypothesis, and funding source. Variability resulted from different interpretation of the tool rather than different information identified in the study reports. CONCLUSION: Low agreement has implications for interpreting systematic reviews. These findings suggest the need for detailed guidance in assessing the risk of bias.
Journal of clinical epidemiology 09/2012; · 2.96 Impact Factor
[show abstract][hide abstract] ABSTRACT: An important step toward improvement of the conduct of pediatric clinical research is the standardization of the ages of children to be included in pediatric trials and the optimal age-subgroups to be analyzed.
We set out to evaluate empirically the age ranges of children, and age-subgroup analyses thereof, reported in recent pediatric randomized clinical trials (RCTs) and meta-analyses. First, we screened 24 RCTs published in Pediatrics during the first 6 months of 2011; second, we screened 188 pediatric RCTs published in 2007 in the Cochrane Central Register of Controlled Trials; third, we screened 48 pediatric meta-analyses published in the Cochrane Database of Systematic Reviews in 2011. We extracted information on age ranges and age-subgroups considered and age-subgroup differences reported.
The age range of children in RCTs published in Pediatrics varied from 0.1 to 17.5 years (median age: 5; interquartile range: 1.8-10.2) and only 25% of those presented age-subgroup analyses. Large variability was also detected for age ranges in 188 RCTs from the Cochrane Central Register of Controlled Trials, and only 28 of those analyzed age-subgroups. Moreover, only 11 of 48 meta-analyses had age-subgroup analyses, and in 6 of those, only different studies were included. Furthermore, most of these observed differences were not beyond chance.
We observed large variability in the age ranges and age-subgroups of children included in recent pediatric trials and meta-analyses. Despite the limited available data, some age-subgroup differences were noted. The rationale for the selection of particular age-subgroups deserves further study.
[show abstract][hide abstract] ABSTRACT: Pain management is integral to the management of hip fracture.
To review the benefits and harms of pharmacologic and nonpharmacologic interventions for managing pain after hip fracture.
25 electronic databases (January 1990 to December 2010), gray literature, trial registries, and reference lists, with no language restrictions.
Multiple reviewers independently and in duplicate screened 9357 citations to identify randomized, controlled trials (RCTs); nonrandomized, controlled trials (non-RCTs); and cohort studies of pain management techniques in older adults after acute hip fracture.
Independent, duplicate data extraction and quality assessment were conducted, with discrepancies resolved by consensus or a third reviewer. Data extracted included study characteristics, inclusion and exclusion criteria, participant characteristics, interventions, and outcomes.
83 unique studies (64 RCTs, 5 non-RCTs, and 14 cohort studies) were included that addressed nerve blockade (n = 32), spinal anesthesia (n = 30), systemic analgesia (n = 3), traction (n = 11), multimodal pain management (n = 2), neurostimulation (n = 2), rehabilitation (n = 1), and complementary and alternative medicine (n = 2). Overall, moderate evidence suggests that nerve blockades are effective for relieving acute pain and reducing delirium. Low-level evidence suggests that preoperative traction does not reduce acute pain. Evidence was insufficient on the benefits and harms of most interventions, including spinal anesthesia, systemic analgesia, multimodal pain management, acupressure, relaxation therapy, transcutaneous electrical neurostimulation, and physical therapy regimens, in managing acute pain.
No studies evaluated outcomes of chronic pain or exclusively examined participants from nursing homes or with cognitive impairment. Systemic analgesics (narcotics, nonsteroidal anti-inflammatory drugs) were understudied during the search period.
Nerve blockade seems to be effective in reducing acute pain after hip fracture. Sparse data preclude firm conclusions about the relative benefits or harms of many other pain management interventions for patients with hip fracture.
Agency for Healthcare Research and Quality.
Annals of internal medicine 08/2011; 155(4):234-45. · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: Background: Pain management is integral to the management of hip fracture. Purpose: To review the benefits and harms of pharmacologic and nonpharmacologic interventions for managing pain after hip fracture. Data Sources: 25 electronic databases (January 1990 to December 2010), gray literature, trial registries, and reference lists, with no language restrictions. Study Selection: Multiple reviewers independently, and in duplicate, screened 9357 citations to identify randomized, controlled trials (RCTs); nonrandomized, controlled trials (non-RCTs); and cohort studies of pain management techniques in older adults after acute hip fracture. Data Extraction: Independent, duplicate data extraction and quality assessment were conducted, with discrepancies resolved by consensus or a third reviewer. Data extracted included study characteristics, inclusion and exclusion criteria, participant characteristics, interventions, and outcomes. Data Synthesis: 83 unique studies (64 RCTs, 5 non-RCTs, and 14 cohort studies) that addressed the following interventions were included: nerve blockade (n = 32), spinal anesthesia (n = 30), systemic analgesia (n = 3), traction (n = 11), multimodal pain management (n = 2), neurostimulation (n = 2), rehabilitation (n = 1), and complementary and alternative medicine (n = 2). Overall, moderate evidence suggests that nerve blockades are effective for relieving acute pain and reducing delirium. Low-level evidence suggests that preoperative traction does not reduce acute pain. Evidence was insufficient about the benefits and harms of most interventions, including spinal anesthesia, systemic analgesia, multimodal pain management, acupressure, relaxation therapy, transcutaneous electrical neurostimulation, and physical therapy regimens, in managing acute pain. Limitations: No studies evaluated outcomes of chronic pain or exclusively examined participants from nursing homes or with cognitive impairment. Systemic analgesics (narcotics, nonsteroidal anti-inflammatory drugs) were understudied during the search period. Conclusion: Nerve blockade seems effective in reducing acute pain after hip fracture. Sparse data preclude firm conclusions about the relative benefits or harms of many other pain management interventions for patients with hip fracture. Primary Funding Source: Agency for Healthcare Research and Quality.
Annals of internal medicine 05/2011; · 13.98 Impact Factor
[show abstract][hide abstract] ABSTRACT: : We examine psychiatric and pediatric clinical management of pediatric mental health in the emergency department (ED).
: We conducted a retrospective review of health care delivery with a random sample of all pediatric mental health presentations (≤18 years) to 2 urban tertiary care EDs between 2004 and 2006 (N = 580).
: The EDs differed significantly in services offered. General emergency medicine-trained physicians provided care at 1 site (54.6%) with a number of visits also managed by a psychiatric crisis team (45.4%). Care at the other ED was delivered by pediatric emergency medicine-trained physicians (99.4%) with no regular on-site psychiatric services. The most common assessment provided across sites and all presentations was for suicidality (66.2%). After controlling for potential confounders, receipt of clinical assessment for homicidality, mood, or reality testing differed between EDs (P = 0.044, P = 0.006, and P = 0.002) with more assessments documented at the psychiatric-resourced ED. Brief counseling was lacking for visits (absence of documentation: 56.1% pediatric-resourced, 23.1% psychiatric-resourced ED); there was no evidence of site differences in provision. More psychiatric consultation was provided at the psychiatric-resourced ED (34.1% vs 27.4%, P = 0.030). Discharge recommendations were lacking in both EDs but were more incomplete for pediatric-resourced ED visits (P = 0.035).
: Consistent and comprehensive clinical management of pediatric mental health presentations was lacking in EDs that had pediatric and psychiatric resources. Prospective evaluations are needed to determine the effect of current clinical ED practices on patient and family outcomes, including symptom reduction and stress, as well as subsequent system use.
Pediatric emergency care 04/2011; 27(4):275-83. · 0.92 Impact Factor
[show abstract][hide abstract] ABSTRACT: ABSTRACT Occupational exposure to beryllium is widespread and is a health risk. The objectives of this study were to develop plausible models to estimate occupational airborne beryllium exposure. Compliance monitoring data were obtained from the Occupational Safety and Health Administration for 12,148 personal measurements of beryllium exposure from 1979 to 2005. Industry codes were maintained as reported or collapsed based on the number of measurements per cell of a job-exposure matrix (JEM). Probability of exposure was predicted based on year, industry, job, and sampling duration. In these models, probability of exposure decreased over time, was highest in full-shift personal samples, and varied with industry and job. The probability of exposure was calculated using 6 JEMs, each providing similar rankings of the likelihood of non-negligible exposure to beryllium. These statistical models, with expert appraisal, are suitable for the assessment of the probability of elevated occupational exposure to beryllium.
Archives of Environmental and Occupational Health 01/2011; 66(2):75-86. · 1.19 Impact Factor
[show abstract][hide abstract] ABSTRACT: In this systematic review, we evaluated the effectiveness of emergency department (ED)-based management interventions for mental health presentations with an aim to provide recommendations for pediatric care.
A search of electronic databases, references, key journals, and conference proceedings was conducted, and primary authors were contacted. Experimental and observational studies that evaluated ED crisis care with pediatric and adult patients were included. Adult-based studies were evaluated for potential translation to pediatric investigation. Pharmacological-based studies were excluded. Inclusion screening, study selection, and methodological quality were assessed by 2 independent reviewers. One reviewer extracted the data, and a second checked for completeness and accuracy. Presentation of study outcomes included odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CI). Meta-analysis was deferred due to clinical heterogeneity in intervention, patient population, and outcome.
Twelve observational studies were included in the review with pediatric (n = 3), and adult or unknown (n = 9) aged participants. Pediatric studies supported the use of specialized care models to reduce hospitalization (OR, 0.45; 95% CI, 0.33-0.60), return ED visits (OR, 0.60; 95% CI, 0.28-1.25), and length of ED stay (MD, -43.1 minutes; 95% CI, -63.088 to -23.11 minutes). In an adult study, reduced hospitalization was reported in a comparison of a crisis intervention team to standard care (OR, 0.59; 95% CI, 0.43-0.82). Five adult-based studies assessed triage scales; however, little overlap in the scales investigated, and the outcomes measured limited comparability and generalizability for pediatrics. In a comparison of a mental health scale to a national standard, a study demonstrated reduced ED wait (MD, -7.7 minutes; 95% CI, -12.82 to -2.58 minutes) and transit (MD, -17.5 minutes; 95% CI, -33.00 to -1.20 minutes) times. Several studies reported a shift in triage scores of psychiatric patients dependent on the scale or nurse training (psychiatric vs emergency), but linkage to system- or patient-based outcomes was not made, limiting clinical interpretation.
Pediatric studies have demonstrated that the use of specialized care models for mental health care can reduce hospitalization, return ED visits, and length of ED stay. Evaluation of these models using more rigorous study designs and the inclusion of patient-based outcomes will improve this evidence base. Adult-based studies provided recommendations for pediatric research including a focus on triage and restraint use.
Pediatric emergency care 12/2010; 26(12):952-62. · 0.92 Impact Factor
[show abstract][hide abstract] ABSTRACT: We evaluate the effectiveness of interventions for pediatric patients with suicide-related emergency department (ED) visits.
We searched of MEDLINE, EMBASE, the Cochrane Library, other electronic databases, references, and key journals/conference proceedings. We included experimental or quasiexperimental studies that evaluated psychosocial interventions for pediatric suicide-related ED visits. Inclusion screening, study selection, and methodological quality were assessed by 2 independent reviewers. One reviewer extracted the data and a second checked for completeness and accuracy. Consensus was reached by conference; disagreements were adjudicated by a third reviewer. We calculated odds ratios, relative risks (RRs), or mean differences for each study's primary outcome, with 95% confidence intervals (CIs). Meta-analysis was deferred because of clinical heterogeneity in intervention, patient population, and outcome.
We included 7 randomized controlled trials and 3 quasiexperimental studies, grouping and reviewing them according to intervention delivery: ED-based delivery (n=1), postdischarge delivery (n=6), and ED transition interventions (n=3). An ED-based discharge planning intervention increased the number of attended post-ED treatment sessions (mean difference=2.6 sessions; 95% CI 0.05 to 5.15 sessions). Of the 6 studies of postdischarge delivery interventions, 1 found increased adherence with service referral in patients who received community nurse home visits compared with simple placement referral at discharge (RR=1.28; 95% CI 1.06 to 1.56). The 3 ED transition intervention studies reported (1) reduced risk of subsequent suicide after brief ED intervention and postdischarge contact (RR=0.10; 95% CI 0.03 to 0.41); (2) reduced suicide-related hospitalizations when ED visits were followed up with interim, psychiatric care (RR=0.41; 95% CI 0.28 to 0.60); and (3) increased likelihood of treatment completion when psychiatric evaluation in the ED was followed by attendance of outpatient sessions with a parent (odds ratio=2.78; 95% CI 1.20 to 6.67).
Transition interventions appear most promising for reducing suicide-related outcomes and improving post-ED treatment adherence. Use of similar interventions and outcome measures in future studies would enhance the ability to derive strong recommendations from the clinical evidence in this area.
Annals of emergency medicine 04/2010; 56(6):649-59. · 4.23 Impact Factor
[show abstract][hide abstract] ABSTRACT: This systematic review evaluated the effectiveness of professional and organizational interventions aimed at improving medical processes, such as documentation or clinical assessments by health care providers, in the care of pediatric emergency department (ED) patients where abuse was suspected.
A search of electronic databases, references, key journals, and conference proceedings was conducted and primary authors were contacted. Studies whose purpose was to evaluate a strategy aimed at improving ED clinical care of suspected abuse were included. Study methodologic quality was assessed by two independent reviewers. One reviewer extracted the data, and a second checked for completeness and accuracy.
Six studies met the inclusion criteria: one randomized controlled trial (RCT), one quasi-RCT, and four observational studies. Study quality ranged from modest (observational studies) to good (trials). Variation in study interventions and outcomes limited between-study comparisons. The quasi-RCT supported self-instructional education kits as a means to improve physician knowledge for both physical abuse (mean +/- standard deviation [SD] pretest score = 13.12 +/- 2.36; mean +/- SD posttest score = 18.16 +/- 1.64) and sexual abuse (mean +/- SD pretest score = 10.81 +/- 3.20; mean +/- SD posttest score = 18.45 +/- 1.79). Modest-quality observational studies evaluated reminder systems for physician documentation with similar results across studies. Compared to standard practice, chart checklists paired with an educational program increased physician consideration of nonaccidental burns in burn cases (59% increase), documentation of time of injury (36% increase), and documentation of consistency (53% increase) and compatibility (55% increase) of reported histories. Decisional flow charts for suspected physical abuse also increased documentation of nonaccidental physical injury (69.5% increase; p < 0.0001) and had a similar significant effect as checklists on increasing documentation of history consistency and compatibility (69.5 and 70.0% increases, respectively; p < 0.0001) when compared to standard practice. No improvements were noted in these studies for documentation of consultations or current status with child protective services. The introduction of a specialized team and crisis center to standardize practice had little effect on physician documentation, but did increase documentation of child protective services involvement (22.7% increase; p < 0.005) and discharge status (23.7% increase; p < 0.02). Referral to social services increased in one study following the introduction of a chart checklist (8.6% increase; p = 0.018). A recently conducted multisite RCT did not support observational findings, reporting no significant effect of educational sessions and/or a chart checklist on ED practices.
The small number of studies identified in this review highlights the need for future quality studies that address care of a vulnerable clinical population. While moderate-quality observational studies suggest that education and reminder systems increase clinical knowledge and documentation, these findings are not supported by a multisite randomized trial. The limited theoretical base for conceptualizing change in health care providers and the influence of the ED environment on clinical practice are limitations to this current evidence base.
Academic Emergency Medicine 02/2010; 17(2):117-25. · 1.76 Impact Factor
[show abstract][hide abstract] ABSTRACT: 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.
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.
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.
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.
[show abstract][hide abstract] ABSTRACT: To determine whether maternal hypothyroxinemia during early pregnancy is associated with adverse perinatal outcomes.
Serum samples of a prospective cohort of 879 women collected at 15-16 weeks of pregnancy were analyzed for thyroid-stimulating hormone (TSH) and free thyroxine (T4) concentrations. Women with TSH levels within the normal reference range (0.15-4.0 mU/L) and free T4 levels below the 10th percentile of the sample (8.5 pmol/L) were classified as hypothyroxinemic and were compared with euthyroid women (who had normal TSH and free T4 levels). Thyroid hormone measures were linked to pregnancy outcomes, including small for gestational age (SGA), standardized birth weight z-score, preterm delivery, and Apgar score used as a measure of early neonatal morbidity.
Among 89 hypothyroxinemic women, there was no evidence of an increased risk for fetal growth restriction, preterm birth, or low Apgar score. The relative risk of delivering an SGA infant was 0.38 (95% CI 0.11 to 1.33), the mean difference in birth weight z-score was 0.035 (95% CI -0.17 to 0.24), and the risk of preterm delivery was 0.79 (95% CI 0.38 to 1.67). None of the hypothyroxinemic women gave birth to an infant with a five-minute Apgar score <7. When free T4 levels were substituted for categories of thyroid hormone function, the pattern of results remained unaltered.
Isolated maternal hypothyroxinemia was not observed to have any adverse effect on fetal growth or pregnancy outcome. This study does not provide evidence to support treatment of this condition to prevent fetal growth restriction or neonatal morbidity.
Journal of obstetrics and gynaecology Canada: JOGC = Journal d'obstetrique et gynecologie du Canada: JOGC 11/2009; 31(11):1015-21.
[show abstract][hide abstract] ABSTRACT: The widespread detection of perfluorinated acids (PFAs) in humans and known developmental toxicity in animals has raised concern about their potential effects on human reproductive health. Our objective was to determine whether increasing maternal exposure to PFAs is associated with adverse effects on fetal growth and length of gestation in women giving birth in Alberta, Canada. We examined the concentrations of perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), and perfluorohexane sulfonate (PFHxS) in a cohort of 252 pregnant women who gave birth to live singletons. Each of the women had undergone an early second trimester prenatal screen, and her serum was analyzed for PFA concentrations. Data on infant and maternal variables were collected from the delivery record completed at birth. Adjusted changes in birth weight per natural log (ng/ml) of PFOA (median 1.5 ng/ml), PFHxS (median 0.97 ng/ml), and PFOS (median 7.8 ng/ml) were -37.4 g (95% confidence interval (CI): -86.0 to 11.2 g), 21.9 g (-23.4 to 67.2 g), and 31.3 g (-43.3 to 105.9 g), respectively. Mean birth weight z-score, standardized for gestational age and gender, length of gestation, and risk of preterm birth did not appear to be influenced by maternal PFA exposure. When PFA concentrations were divided into tertiles, similar patterns were observed. These results suggest that maternal PFA exposure has no substantial effect on fetal weight and length of gestation at the concentrations observed in this population.
Journal of Exposure Science and Environmental Epidemiology 10/2009; 20(7):589-97. · 3.19 Impact Factor