Biomedical subjects

Lisa Hartling

Publications and source records attributed to Lisa Hartling.

At least 19 recordsLinked to original sources

PubMed2006

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.

Child↗

PubMed2006

Single data extraction generated more errors than double data extraction in systematic reviews.

BACKGROUND AND OBJECTIVE: To conduct a pilot study to compare the frequency of errors that accompany single vs. double data extraction, compare the estimate of treatment effect derived from these methods, and compare the time requirements for these methods. METHODS: Reviewers were randomized to the role of data extractor or data verifier, and were blind to the study hypothesis. The frequency of errors associated with each method of data extraction was compared using the McNemar test. The data set for each method was used to calculate an efficacy estimate by each method, using standard meta-analytic techniques. The time requirement for each method was compared using a paired t-test. RESULTS: Single data extraction resulted in more errors than double data extraction (relative difference: 21.7%, P = .019). There was no substantial difference between methods in effect estimates for most outcomes. The average time spent for single data extraction was less than the average time for double data extraction (relative difference: 36.1%, P = .003). CONCLUSION: In the case that single data extraction is used in systematic reviews, reviewers and readers need to be mindful of the possibility for more errors and the potential impact these errors may have on effect estimates.

Data Interpretation, Statistical↗

PubMed2006

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.

Adolescent↗

PubMed2006

A systematic review of intentional delivery in women with preterm prelabor rupture of membranes.

OBJECTIVE: To evaluate the effect of intentional delivery versus expectant management in women with preterm prelabor rupture of membranes (PPROM). METHODS: We searched electronic databases and trials registries, contacted experts, and checked reference lists of relevant studies. Studies were included if they were randomized controlled trials comparing intentional delivery versus expectant management after PPROM, the gestational age of participants was between 30 and 36 weeks, and the study reported one of several pre-determined outcomes. RESULTS: Four studies were included in the meta-analysis. No difference was found between intentional delivery and expectant management in neonatal intensive care unit (NICU) length of stay (LOS) (weighted mean difference (WMD) -0.81 day, 95% confidence interval (CI) -1.66, 0.04), respiratory distress syndrome (risk difference (RD) -0.01, 95% CI -0.07, 0.06), and confirmed neonatal sepsis (RD -0.01, 95% CI -0.05, 0.04). One study found a significantly lower incidence of suspected neonatal sepsis among the intentional delivery group (RD -0.31, 95% CI -0.50, -0.12; number needed to treat (NNT) 3, 95% CI 2, 8). Maternal LOS was significantly shorter for the intentional delivery group (WMD -1.39 day, 95% CI -2.03, -0.75). There was a significant difference in the incidence of clinical chorioamnionitis favoring intentional delivery (RD -0.16, 95% CI -0.23, -0.10; NNT 6, 95% CI 5, 11). There was no significant difference in the incidence of other maternal outcomes, including cesarean section (RD 0.05, 95% CI -0.01, 0.11). CONCLUSIONS: Intentional delivery may be favorable to expectant management for some maternal outcomes (chorioamnionitis and LOS). There is insufficient evidence to suggest that either strategy is beneficial or harmful for the baby. Large multicenter trials with primary neonatal outcomes are required to assess whether intentional delivery is associated with less neonatal morbidity.

Cesarean Section↗

PubMed2005

Meta-analysis: secondary prevention programs for patients with coronary artery disease.

BACKGROUND: Although supervised exercise programs reduce mortality in survivors of myocardial infarction, the effects of other types of cardiac secondary prevention programs are unknown. PURPOSE: To determine the effectiveness of secondary cardiac prevention programs with and without exercise components. DATA SOURCES: The authors searched MEDLINE (1966-2004), the Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, SIGLE, and the Cochrane Effective Practice and Organization of Care Study Registry. They also contacted primary study authors and hand-searched bibliographies provided by the Centers for Medicare & Medicaid Services. STUDY SELECTION: Randomized clinical trials. DATA EXTRACTION: Two reviewers chose studies and extracted data independently; random-effects summary risk ratios were calculated. DATA SYNTHESIS: The authors identified 63 randomized trials (21 295 patients with coronary disease). The summary risk ratio was 0.85 (95% CI, 0.77 to 0.94) for all-cause mortality, but this result differed over time with a risk ratio of 0.97 (CI, 0.82 to 1.14) at 12 months and 0.53 (CI, 0.35 to 0.81) at 24 months. The summary risk ratio was 0.83 (CI, 0.74 to 0.94) for recurrent myocardial infarction over a median follow-up of 12 months. Effects were similar for programs that included risk factor education or counseling with a structured exercise component (risk ratio, 0.88 [CI, 0.74 to 1.04] for mortality and 0.62 [CI, 0.44 to 0.87] for myocardial infarction), for programs that included risk factor education or counseling without an exercise component (risk ratio, 0.87 [CI, 0.76 to 0.99] for mortality and 0.86 [CI, 0.72 to 1.03] for myocardial infarction), and for programs that were solely exercise-based (risk ratio, 0.72 [CI, 0.54 to 0.95] for mortality and 0.76 [CI, 0.57 to 1.01] for myocardial infarction). Most of these programs improved quality of life or functional status, but effect sizes were small. LIMITATIONS: Although these programs may reduce total health care costs, published data on the costs of the programs are inadequate to conclusively comment on their cost-effectiveness. CONCLUSIONS: A wide variety of secondary prevention programs improve health outcomes in patients with coronary disease.

Cause of Death↗

PubMed2005

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.

Adolescent↗

PubMed2005

A randomized controlled trial of an educational intervention to prevent the chronic pain of whiplash associated disorders following rear-end motor vehicle collisions.

STUDY DESIGN: Concealed allocation, multicenter, single-blind, randomized controlled clinical trial. OBJECTIVE: To assess the efficacy of an educational video in the tertiary prevention of persistent WAD symptoms following rear-end motor vehicle collisions (MVCs). SUMMARY OF BACKGROUND DATA: Whiplash-associated disorders (WAD) are an important and costly health problem. There is a lack of high quality evidence surrounding efficacy of treatments for WAD. Existing research supports active interventions and early return to regular activities. METHODS: Consecutive patients presenting to four tertiary care emergency departments following rear-end MVCs were eligible. Following informed consent, patients were allocated, using central randomization, to receive an educational video plus usual care or usual care alone. The video provided reassurance, and advice about posture, return to regular activities, exercises, and pain-relief methods. Data were collected by telephone using standardized questionnaires. The primary outcome was presence of Persistent WAD Symptoms at 24 weeks postinjury, based on the frequency and severity of neck, shoulder, or upper back pain. The absolute difference in proportion of patients with persistent WAD symptoms and rate ratios were calculated. Changes in pain scores were compared using the Mann-Whitney U test. RESULTS: The intervention (n = 206) and control (n = 199) groups were similar at baseline (mean age 38.4 years; 64% female). Overall, the proportion of subjects with Persistent WAD Symptoms decreased from 89.1% at baseline to 33.6% at 24 weeks after injury. At 24 weeks, the proportion of subjects with persistent WAD symptoms in the intervention group was 7.9% (95% CI, -2.0, 17.8) lower than the control group. The median improvement in pain score at 24 weeks was 3 for the intervention group and 2 for the control group (P = 0.016). CONCLUSION: The presence of persistent WAD symptoms following simple rear-end MVCs was high in this sample. The video group demonstrated a trend toward less severe WAD symptoms. We recommend evaluating other educational interventions that could reduce WAD symptoms.

Adult↗

PubMed2005

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.

Databases, Bibliographic↗

PubMed2005

Challenges in systematic reviews of therapeutic devices and procedures.

The authors discuss 3 challenges in conducting and interpreting any systematic review that are particularly relevant for systematic reviews of therapeutic devices or surgical procedures: 1) inclusion or exclusion of grey literature, 2) the role of nonrandomized studies, and 3) issues in applying the results to clinical care that are unique to the surgical and therapeutic device literature. The authors also discuss empirical evidence related to these topics and illustrate how reviewers in the Agency for Healthcare Research and Quality's Evidence-based Practice Center program have dealt with these challenges in developing evidence reports for decision makers and clinicians about therapeutic devices or surgical procedures.

Clinical Trials as Topic↗

PubMed2005

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.

Acute Disease↗

PubMed2005

Heat loss prevention: a systematic review of occlusive skin wrap for premature neonates.

OBJECTIVE: To systematically identify and synthesize investigations of the effectiveness of occlusive skin wrap for reducing heat loss in premature infants born at less than 36 weeks gestations. STUDY DESIGN: Systematic review. RESULTS: Three randomized controlled trials (RCT) and five historical controlled trials (HCT) were included. Meta-analysis shows wrapped infants had significantly higher admission temperatures than unwrapped infants (RCTs WMD 0.63 degrees C, 95% confidence interval (CI) 0.38, 0.87; HCTs WMD 0.96 degrees C, 95% CI 0.66, 1.27). A statistically significant difference in mortality was not found between wrapped and unwrapped infants in the RCTs (RR 0.72, 95% CI 0.36, 1.45) or the HCTs (RR 0.76, 95% CI 0.51, 1.13). CONCLUSIONS: The findings suggest that occlusive skin wrap prevents heat loss in premature infants. The meta-analysis lacked the power to provide definitive results regarding the effect of wrap on mortality.

Body Temperature Regulation↗

PubMed2005

The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis.

BACKGROUND: Exogenous melatonin has been increasingly used in the management of sleep disorders. PURPOSE: To conduct a systematic review of the efficacy and safety of exogenous melatonin in the management of primary sleep disorders. DATA SOURCES: A number of electronic databases were searched. We reviewed the bibliographies of included studies and relevant reviews and conducted hand-searching. STUDY SELECTION: Randomized controlled trials (RCTs) were eligible for the efficacy review, and controlled trials were eligible for the safety review. DATA EXTRACTION: One reviewer extracted data, while the other verified data extracted. The Random Effects Model was used to analyze data. DATA SYNTHESIS: Melatonin decreased sleep onset latency (weighted mean difference [WMD]: -11.7 minutes; 95% confidence interval [CI]: -18.2, -5.2)); it was decreased to a greater extent in people with delayed sleep phase syndrome (WMD: -38.8 minutes; 95% CI: -50.3, -27.3; n=2) compared with people with insomnia (WMD: -7.2 minutes; 95% CI: -12.0, -2.4; n=12). The former result appears to be clinically important. There was no evidence of adverse effects of melatonin. CONCLUSIONS: There is evidence to suggest that melatonin is not effective in treating most primary sleep disorders with short-term use (4 weeks or less); however, additional large-scale RCTs are needed before firm conclusions can be drawn. There is some evidence to suggest that melatonin is effective in treating delayed sleep phase syndrome with short-term use. There is evidence to suggest that melatonin is safe with short-term use (3 months or less).

Humans↗

PubMed2004

Systematic review: cardiac resynchronization in patients with symptomatic heart failure.

BACKGROUND: Even with optimal pharmacotherapy, symptomatic heart failure is associated with substantial morbidity and mortality. PURPOSE: To determine the efficacy and safety of cardiac resynchronization therapy in adults with advanced systolic heart failure. DATA SOURCES: The Cochrane Central Register of Controlled Trials (2002, volume 4), MEDLINE (1980-2003), EMBASE (1980-2003), other electronic databases, and U.S. Food and Drug Administration reports. We contacted primary study authors and device manufacturers, and we hand searched bibliographies of relevant papers and conference proceedings. STUDY SELECTION: Randomized, controlled clinical trials for efficacy and controlled trials plus prospective cohort studies for safety. DATA EXTRACTION: Two reviewers chose studies and extracted data independently; random-effects models were used for analyses. DATA SYNTHESIS: Nine trials were included in the efficacy review (3216 patients). All trial participants had reduced ejection fraction and prolonged QRS duration, and 85% had New York Heart Association (NYHA) class III or IV symptoms. Cardiac resynchronization therapy improved ejection fraction (weighted mean difference, 0.035 [95% CI, 0.015 to 0.055]), quality of life (weighted mean reduction in score on the Minnesota Living with Heart Failure Questionnaire, 7.6 points [CI, 3.8 to 11.5 points]), and function (58% vs. 37% of patients improved by at least 1 NYHA class). Heart failure hospitalizations were reduced by 32% (relative risk [RR], 0.68 [CI, 0.41 to 1.12]), with benefits most marked in patients with NYHA class III or IV symptoms at baseline (RR, 0.65 [CI, 0.48 to 0.88]; number needed to treat for benefit [NNT(B)], 12). All-cause mortality was reduced by 21% (RR, 0.79 [CI, 0.66 to 0.96]; NNT(B), 24), driven largely by reductions in death from progressive heart failure (RR, 0.60 [CI, 0.36 to 1.01]). Eighteen studies (total of 3701 patients with cardiac resynchronization devices) were included in the safety review. Implant success rate was 90% (CI, 89% to 91%), and 0.4% of patients died during implantation (CI, 0.2% to 0.7%). Over a median 6-month follow-up, leads dislodged in 9% of patients (CI, 7% to 10%) and mechanical malfunctions occurred in 7% (CI, 5% to 8%). LIMITATIONS: These trials enrolled only patients with heart failure with NYHA class III or IV symptoms despite medical therapy, a prolonged QRS duration, and reduced ejection fraction; in addition, experienced providers implanted the devices. Because all but one of these trials randomly assigned patients after device implantation, their results may overestimate the potential benefits of cardiac resynchronization. Finally, since few patients in these trials had bradyarrhythmias or atrial fibrillation, the role of cardiac resynchronization in such patients is uncertain. CONCLUSIONS: In selected patients with heart failure, cardiac resynchronization therapy improves functional and hemodynamic status, reduces heart failure hospitalizations, and reduces all-cause mortality.

Cardiac Pacing, Artificial↗

PubMed2004

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.

Child↗

PubMed2004

Factors influencing the publication of randomized controlled trials in child health research.

BACKGROUND: Publication bias threatens the validity of clinical decisions. The root causes are relatively unknown, and there is limited investigation in child research literature. OBJECTIVES: To identify factors associated with subsequent nonpublication of abstracts presented at the Society for Pediatric Research meetings, and to determine the relative importance of the reasons identified for nonpublication. DESIGN: A cross-sectional survey was used to ask researchers about their reasons for the selective publication of randomized controlled trials (RCTs). The authors of 393 RCTs presented at the Society for Pediatric Research meetings from 1992 to 1995 were surveyed. A modified Total Design Method for mail surveys was used, with a reminder sent to all potential respondents 1 week after the initial mailing and full mailings sent to nonrespondents at 3 and 10 weeks following the initial mailing. RESULTS: One hundred sixty-six (45%) completed surveys were returned, and 119 (72%) abstracts were published as full manuscripts. Factors significantly associated with nonpublication identified through multiple logistic regression were the respondent's report of scientific merit and significance of results. Of the 47 studies that were not published, only 8 (17%) had been submitted for publication. Authors of unpublished studies identified the following as important reasons for not publishing: not enough time (56.4 responded important or very important); trouble with coauthors (28.9); and journal unlikely to accept (26.3). CONCLUSIONS: Of the RCTs presented and not subsequently published, the majority (83%) were never submitted for publication. The most common reason cited by authors for nonpublication was lack of time.

Alberta↗

PubMed2004

A systematic review of interventions to prevent childhood farm injuries.

OBJECTIVE: The goal of the study was to systematically review the global body of evidence surrounding the effectiveness of interventions for the prevention of acute pediatric agricultural injuries. A specific focus was the effectiveness of the North American Guidelines for Children's Agricultural Tasks. METHODS: Two reviewers independently screened studies and applied inclusion criteria on the basis of searches of 17 bibliographic databases (eg, Medline and Embase). We also screened reference lists of relevant studies and contacted experts in the area. Studies were included if they represented primary research, a comparison group was used, the study population included children or the intervention was directly applicable to children, and objective outcomes were reported. Two reviewers independently assessed the methodologic quality of included studies with the Downs and Black checklist. A qualitative analysis was performed because of extensive heterogeneity among studies. RESULTS: We included 23 controlled studies, ie, 4 randomized, controlled trials, 5 controlled trials, and 14 quasiexperimental or observational studies. Only 8 of the relevant studies were published in peer-reviewed journals. School-based programs appeared to be effective at increasing short-term knowledge acquisition; outcomes were enhanced with active, hands-on participation, as opposed to passive activities. Safety day camps showed positive results for knowledge acquisition. Tractor training programs and community- and farm-based interventions showed mixed results. Studies examining the North American Guidelines for Children's Agricultural Tasks suggested that uptake improves if dissemination is accompanied by a farm visit from a safety specialist or if information about child development principles is provided in conjunction with the guidelines. CONCLUSIONS: There is a lack of randomized, controlled trials and community-based trials in this area. Studies primarily examined intermediate outcomes, such as knowledge acquisition; few studies evaluated changes in injury rates. The interventions targeted at children and youths that were evaluated focused on educational interventions. There is both the need and potential for the development and evaluation of injury control interventions for children, particularly programs addressing lethal injuries to young/preschool-aged children.

Accident Prevention↗

PubMed2003

A meta-analysis of randomized controlled trials evaluating the efficacy of epinephrine for the treatment of acute viral bronchiolitis.

BACKGROUND: Controversy exists surrounding the use of bronchodilators for bronchiolitis. Epinephrine hydrochloride is being used with increasing frequency in this group; however, its efficacy has not been systematically reviewed. OBJECTIVE: To systematically review randomized controlled trials comparing inhaled or systemic epinephrine vs placebo or other bronchodilators. DATA SOURCES: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, primary authors, and reference lists. STUDY SELECTION: Studies were included if they (1) were randomized, controlled trials; (2) involved children 2 years or younger with bronchiolitis; and (3) presented quantitative outcomes. DATA EXTRACTION: Two reviewers independently extracted data and assessed study quality. DATA SYNTHESIS: We included 14 studies (7 inpatient, 6 outpatient, and 1 patient status unknown). Thirteen of forty-five comparisons were significant. Among outpatients, results favored epinephrine compared with placebo for clinical score at 60 minutes (standardized mean difference [SMD], -0.81; 95% confidence interval [CI], -1.56 to -0.07), oxygen saturation at 30 minutes (weighted mean difference [WMD], 2.79; 95% CI, 1.50-4.08), respiratory rate at 30 minutes (WMD, -4.54; 95% CI, -8.89 to -0.19), and improvement (odds ratio, 25.06; 95% CI, 4.95-126.91); among inpatients, for clinical score at 60 minutes (SMD, -0.52; 95% CI, -1.00 to -0.03). Among outpatients, results favored epinephrine compared with albuterol sulfate (salbutamol) for oxygen saturation at 60 minutes (WMD, 1.91; 95% CI, 0.38-3.44), heart rate at 90 minutes (WMD, -14.00; 95% CI, -22.95 to -5.05), respiratory rate at 60 minutes (WMD, -7.76; 95% CI, -11.35 to -4.17), and improvement (odds ratio, 4.51; 95% CI, 1.93-10.53); among inpatients, respiratory rate at 30 minutes (WMD, -5.12; 95% CI, -6.83 to -3.41). CONCLUSIONS: Epinephrine may be favorable compared with placebo and albuterol for short-term benefits among outpatients. There is insufficient evidence to support the use of epinephrine among inpatients. Large, multicentered trials are required before routine use among outpatients can be strongly recommended.

Acute Disease↗

PubMed2003

Tissue adhesives for traumatic lacerations: a systematic review of randomized controlled trials.

OBJECTIVE: To summarize the best available evidence for the effect of tissue adhesives (TAs) in managing traumatic lacerations in children and adults. METHODS: A search was conducted using the Cochrane Controlled Trials Register, Medline, and EMBase for relevant studies. The authors also searched the citations of selected studies and contacted relevant authors and manufacturers. The search included randomized controlled trials (RCTs) comparing a TA versus standard wound closure (sutures, staples, adhesive strips) (SWC) or two TAs for acute, linear, low-tension, traumatic lacerations in an emergency or primary care setting. Data were extracted by one reviewer and checked for accuracy by a second reviewer. Two reviewers independently assessed masked copies for quality. Outcomes of cosmesis (subgroups of age, wound location, and need for deep sutures), pain, procedure time, ease of use, and complications were analyzed separately for two comparisons: 1). TA versus SWC; and 2). TA versus TA. RESULTS: Eight studies compared a TA with SWC. No significant difference was found for cosmesis at any time point examined. Subgroup analysis was possible only for age; no significant difference was found. Pain scores [Parent Visual Analogue Scale weighted mean difference (VAS WMD) = -15.7 mm; 95% CI = -21.9 to -9.5] and procedure time (WMD = -5.7 minutes; 95% CI = -8.2 to -3.1) significantly favored TAs. Small, statistically significant risk differences were found for dehiscence [favoring SWC; number needed to harm (NNH) = 25; 95% CI = 14 to 100] and erythema (favoring TAs; NNH = 8; 95% CI = 4 to 100). Only one study compared two TAs (butylcyanoacrylate versus octylcyanoacrylate) for pediatric facial lacerations. No significant difference was found for cosmesis, pain, procedure time, or complications. CONCLUSIONS: TAs are an acceptable alternative to SWC for simple traumatic lacerations. No difference in cosmesis was found between TAs and SWC, or between different TAs. Tissue adhesives offer the benefits of decreased procedure time and less pain, compared with SWC. A small increased rate of dehiscence with TAs must be considered when choosing the closure method (NNH = 25).

Clinical Trials as Topic↗