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1.

Objective

Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.

Data Sources

We searched 25 electronic databases from their first available date until October 2014.

Study Selection

Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.

Data Extraction and Synthesis

4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.

Main Outcome Measures

Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated), the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.

Results

Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years) receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07) and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.

Conclusions and Relevance

This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.  相似文献   

2.

Background

Uterine fibroids are common, often symptomatic and a third of women need repeated time off work. Consequently 25% to 50% of women with fibroids receive surgical treatment, namely myomectomy or hysterectomy. Hysterectomy is the definitive treatment as fibroids are hormone dependent and frequently recurrent. Medical treatment aims to control symptoms in order to replace or delay surgery. This may improve the outcome of surgery and prevent recurrence.

Purpose

To determine whether any medical treatment can be recommended in the treatment of women with fibroids about to undergo surgery and in those for whom surgery is not planned based on currently available evidence.

Study Selection

Two authors independently identified randomised controlled trials (RCT) of all pharmacological treatments aimed at the treatment of fibroids from a list of references obtained by formal search of MEDLINE, EMBASE, Cochrane library, Science Citation Index, and ClinicalTrials.gov until December 2013.

Data Extraction

Two authors independently extracted data from identified studies.

Data Synthesis

A Bayesian network meta-analysis was performed following the National Institute for Health and Care Excellence—Decision Support Unit guidelines. Odds ratios, rate ratios, or mean differences with 95% credible intervals (CrI) were calculated.

Results and Limitations

A total of 75 RCT met the inclusion criteria, 47 of which were included in the network meta-analysis. The overall quality of evidence was very low. The network meta-analysis showed differing results for different outcomes.

Conclusions

There is currently insufficient evidence to recommend any medical treatment in the management of fibroids. Certain treatments have future promise however further, well designed RCTs are needed.  相似文献   

3.

Background

The radial forearm free flap (RFFF) has been widely used with increasing frequency in head and neck reconstruction following extirpative surgery. The controversy of the venous anastomoses patterns still exists. Thus, we conducted a meta-analysis to assess the relationship between the venous anastomoses patterns and venous compromise.

Methods

MEDLINE, PubMed, Web of Science, and Wanfang databases were searched for studies reporting the different venous anastomoses patterns of the RFFF. A meta-analysis was conducted using the random effects models. Publication bias and sensitivity analysis were also assessed.

Results

6 studies with 992 cases were included in this meta-analysis. The dual anastomosis group tended to have a lower incidence of venous compromise (RR = 1.39). However, the difference was not statistically significant (95%CI: 0.59, 3.24).

Conclusions

This meta-analysis indicated that performing dual venous anatomoses consisting of superficial and deep systems conferred a tendency of the reduction with regard to venous compromise.  相似文献   

4.

Background

Meta-analyses are considered the gold standard of evidence-based health care, and are used to guide clinical decisions and health policy. A major limitation of current meta-analysis techniques is their inability to pool ordinal data. Our objectives were to determine the extent of this problem in the context of neurological rating scales and to provide a solution.

Methods

Using an existing database of clinical trials of oral neuroprotective therapies, we identified the 6 most commonly used clinical rating scales and recorded how data from these scales were reported and analysed. We then identified systematic reviews of studies that used these scales (via the Cochrane database) and recorded the meta-analytic techniques used. Finally, we identified a statistical technique for calculating a common language effect size measure for ordinal data.

Results

We identified 103 studies, with 128 instances of the 6 clinical scales being reported. The majority– 80%–reported means alone for central tendency, with only 13% reporting medians. In analysis, 40% of studies used parametric statistics alone, 34% of studies employed non-parametric analysis, and 26% did not include or specify analysis. Of the 60 systematic reviews identified that included meta-analysis, 88% used mean difference and 22% employed difference in proportions; none included rank-based analysis. We propose the use of a rank-based generalised odds ratio (WMW GenOR) as an assumption-free effect size measure that is easy to compute and can be readily combined in meta-analysis.

Conclusion

There is wide scope for improvement in the reporting and analysis of ordinal data in the literature. We hope that adoption of the WMW GenOR will have the dual effect of improving the reporting of data in individual studies while also increasing the inclusivity (and therefore validity) of meta-analyses.  相似文献   

5.

Objective

To evaluate the evidence for the effectiveness and safety of Shensongyangxin Capsules (SSYX) for treating paroxysmal atrial fibrillation (PAF).

Methods

We searched for randomized clinical trials for SSYX in PAF up to June 2015. The Cochrane risk of bias tool was used to assess the methodological quality. RevMan 5.3 was used to synthesize the results.

Results

We included 22 trials involving 2,347 PAF patients. The quality of the included studies was generally poor. The results of the meta-analysis showed that SSYX plus routine treatment was more effective at improving P-wave dispersion (Pwd) and the frequency of PAF attacks compared with routine treatment alone. The results from the included trials that compared SSYX plus routine treatment and arrhythmic drugs plus routine treatment were inconsistent. Trials reported on Pwd, quality of life, frequency of PAF attacks or maintenance rate of sinus rhythm and found that SSYX combined with anti-arrhythmic drugs plus routine treatment was more effective than anti-arrhythmic drugs plus routine treatment. Four of the trials reported adverse events, indicating that SSYX was potentially safer than anti-arrhythmic drugs.

Conclusions

There appears to be some benefit from the use of SSYX. However, due to poor methodological quality, we could not draw confirmative conclusions regarding the beneficial effect of using SSYX.  相似文献   

6.

Background

The reversibility of new/novel oral anticoagulants (NOAC) is not well understood, whereas the reversal strategies for bleeding associated with vitamin k antagonists (VKA), such as warfarin, is well established. It is unknown whether outcomes are different between bleeds occurring with NOAC compared to VKA use.

Objectives

This systematic review and meta-analysis of randomized controlled trials determines the relative odds of fatal bleeding given that a patient suffered a major bleed while on NOAC versus VKA therapy.

Search Methods

Data on major and fatal bleeding events was sought from randomized controlled trials of NOAC agents compared to VKAs.

Main Results

20 trials were included in the meta-analysis. From which, 4056 first-time, major bleeding events were reported and included in the primary analysis. The summary odds ratio for the conditional odds of fatal bleeding given that a major bleeding event occurred was 0.65 [0.52, 0.81] favoring the NOAC agents (p = 0.0001). The reduced odds of fatal bleeding with NOACs was not demonstrated after controlling for bleeding location. Given that an intracranial bleeding event occurred, the summary odds ratio for the conditional odds of fatal bleeding was 0.96 [0.70, 1.32]. For extracranial bleeding events, the summary odds ratio was also statistically insignificant at 0.945 [0.66, 1.35].

Author’s Conclusions

The odds ratio calculated in this meta-analysis showed a reduced odds of death in major bleeding associated with NOAC use. This risk reduction was due to a disproportionate amount of intracranial bleeding in the VKA arms. For any given bleeding site, there was no evidence of a significant difference in fatal outcomes from bleeds associated with NOAC versus VKA use.

Protocol Registration

Protocol registered on PROSPERO under CRD42014013294.  相似文献   

7.

Background

A systematic review and meta-analysis was performed in randomized controlled trials (RCTs) to compare porcine small intestinal submucosa (SIS) with polypropylene in open inguinal hernia repair.

Method

Electronic databases MEDLINE, Embase, and the Cochrane Library were used to compare patient outcomes for the two groups via meta-analysis.

Result

A total of 3 randomized controlled trials encompassing 200 patients were included in the meta-analysis. There was no significant difference in recurrence (P = 0.16), hematomas (P = 0.06), postoperative pain within 30 days (P = 0.45), or postoperative pain after 1 year (P = 0.12) between the 2 groups. The incidence of discomfort was significantly lower (P = 0.0006) in the SIS group. However, the SIS group experienced a significantly higher incidence of seroma (P = 0.03).

Conclusions

Compared to polypropylene, using SIS in open inguinal hernia repair is associated with a lower incidence of discomfort and a higher incidence of seroma. However, well-designed larger RCT studies with a longer follow-up period are needed to confirm these findings.  相似文献   

8.

Importance

There is growing evidence that vitamin D plays a role in the pathogenesis of asthma but it is unclear whether supplementation during childhood may improve asthma outcomes.

Objectives

The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of vitamin D supplementation as a treatment or adjunct treatment for asthma.

Data Sources

We searched MEDLINE, Embase, CENTRAL, and CINAHL through July 2014.

Study Selection

We included RCTs that evaluated vitamin D supplementation in children versus active control or placebo for asthma.

Data Extraction and Synthesis

One reviewer extracted data and one reviewer verified data accuracy. We qualitatively summarized the main results of efficacy and safety and meta-analyzed data on comparable outcomes across studies. We used GRADE for strength of evidence.

Main Outcome Measures

Main planned outcomes measures were ED visits and hospitalizations. As secondary outcomes, we examined measures of asthma control, including frequency of asthma exacerbations, asthma symptom scores, measures of lung function, β2-agonist use and daily steroid use, adverse events and 25-hydroxyvitamin D levels.

Results

Eight RCTs (one parallel, one crossover design) comprising 573 children aged 3 to 18 years were included. One study (moderate-quality, n = 100) reported significantly less ED visits for children treated with vitamin D. No other studies examined the primary outcome (ED visits and hospitalizations). There was a reduced risk of asthma exacerbations in children receiving vitamin D (low-quality; RR 0.41, 95% CI 0.27 to 0.63, 3 studies, n = 378). There was no significant effect for asthma symptom scores and lung function. The serum 25(OH)D level was higher in the vitamin D group at the end of the intervention (low-quality; MD 19.66 nmol/L, 95% CI 5.96 nmol/L to 33.37 nmol/L, 5 studies, n = 167).

Limitations

We identified a high degree of clinical diversity (interventions and outcomes) and methodological heterogeneity (sample size and risk of bias) in included trials.

Conclusions and Relevance

Randomized controlled trials provide some low-quality evidence to support vitamin D supplementation for the reduction of asthma exacerbations. Evidence on the benefits of vitamin D supplementation for other asthma-related outcomes in children is either limited or inconclusive. We recommend that future trials focus on patient-relevant outcomes that are comparable across studies, including standardized definitions of asthma exacerbations.  相似文献   

9.

Background

Shugan Jianpi Zhixie therapy (SJZT) has been widely used to treat diarrhea-predominant irritable bowel syndrome (IBS-D), but the results are still controversial. A meta-analysis of randomized, double-blind, placebo-controlled trials was performed to assess the efficacy and tolerability of SJZT for IBS-D.

Methods

The MEDLINE, EMBASE, Cochrane Library, the China National Knowledge Infrastructure database, the Chinese Biomedical Literature database and the Wanfang database were searched up to June 2014 with no language restrictions. Summary estimates, including 95% confidence intervals (CI), were calculated for global symptom improvement, abdominal pain improvement, and Symptom Severity Scale (BSS) score.

Results

Seven trials (N=954) were included. The overall risk of bias assessment was low. SJZT showed significant improvement for global symptom compared to placebo (RR 1.61; 95% CI 1.24, 2.10; P =0.0004; therapeutic gain = 33.0%; number needed to treat (NNT) = 3.0). SJZT was significantly more likely to reduce overall BSS score (SMD –0.67; 95% CI –0.94, –0.40; P < 0.00001) and improve abdominal pain (RR 4.34; 95% CI 2.64, 7.14; P < 0.00001) than placebo. The adverse events of SJZT were no different from those of placebo.

Conclusions

This meta-analysis suggests that SJZT is an effective and safe therapy option for patients with IBS-D. However, due to the high clinical heterogeneity and small sample size of the included trials, further standardized preparation, large-scale and rigorously designed trials are needed.  相似文献   

10.

Background

Cardiopulmonary arrest in children is an uncommon event, and often fatal. Resuscitation is often attempted, but at what point, and under what circumstances do continued attempts to re-establish circulation become futile? The uncertainty around these questions can lead to unintended distress to the family and to the resuscitation team.

Objectives

To define the likely outcomes of cardiopulmonary resuscitation in children, within different patient groups, related to clinical features.

Data Sources

MEDLINE, MEDLINE in-Process & Other non-Indexed Citations, EMBASE, Cochrane database of systematic reviews and Cochrane central register of trials, Database of Abstracts of Reviews of Effects (DARE), the Health Technology Assessment database, along with reference lists of relevant systematic reviews and included articles.

Study Eligibility Criteria

Prospective cohort studies which derive or validate a clinical prediction model of outcome following cardiopulmonary arrest.

Participants and Interventions

Children or young people (aged 0 – 18 years) who had cardiopulmonary arrest and received an attempt at resuscitation, excluding resuscitation at birth.

Study Appraisal and Synthesis Methods

Risk of bias assessment developed the Hayden system for non-randomised studies and QUADAS2 for decision rules. Synthesis undertaken by narrative, and random effects meta-analysis with the DerSimonian-Laird estimator.

Results

More than 18,000 episodes in 16 data sets were reported. Meta-analysis was possible for survival and one neurological outcome; others were reported too inconsistently. In-hospital patients (average survival 37.2% (95% CI 23.7 to 53.0%)) have a better chance of survival following cardiopulmonary arrest than out-of-hospital arrests (5.8% (95% CI 3.9% to 8.6%)). Better neurological outcome was also seen, but data were too scarce for meta-analysis (17% to 71% ‘good’ outcomes, compared with 2.8% to 3.2%).

Limitation

Lack of consistent outcome reporting and short-term neurological outcome measures limited the strength of conclusions that can be drawn from this review.

Conclusions and Implications of Key Findings

There is a need to collaboratively, prospectively, collect potentially predictive data on these rare events to understand more clearly the predictors of survival and long-term neurological outcome.

Systematic Review Registration Number

PROSPERO 2013:CRD42013005102  相似文献   

11.

Background

Both tenotomy and tenodesis have been widely used for the treatment of long head of biceps tendon (LHBT) lesions, but the optimal strategy remains considerably controversial. In this meta-analysis of published studies, we compared the results of the two procedures.

Methods

A literature search that compared tenotomy with tenodesis was performed using MEDLINE, and Embase until August 2014. A total of 7 studies reporting data on 622 subjects were included. Study quality was evaluated using the PEDro critical appraisal tool and the NO quality assessment tool.

Results

Data synthesis showed higher functional outcomes, a lower complication rate, and longer surgical time in patients managed with tenodesis compared to tenotomy (Constant score, P = 0.02; Popeye sign, P < 0.001; cramp pain, P = 0.04; surgical time, P < 0.001, respectively).

Conclusion

This meta-analysis indicates that tenodesis results in better arm function and lower incidences of cramp pain and Popeye sign in LHBT lesions, while the procedure required longer surgical time compared to tenotomy. More sufficiently powered studies would be required to further determine the optimal strategy.  相似文献   

12.

Objective

To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE) introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.

Materials and Methods

Any clinical trial (as defined by ICMJE) published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry) and conducted after July 2005 (or 2007 for two journals) was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.

Results

Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6%) were deemed unregistered, 61 (33.7%) were retrospectively registered, 37 (20.4%) had unclear POMs either in the article or the registry and 2 (1.1%) were registered in an inaccessible trial registry. Only 60 (33.1%) studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3%) showed evidence of selective outcome reporting and 16 (26.7%) demonstrated a change in participant numbers of 20% or more; only 26 (14.4%) of the 181 the trials were prospectively registered and did not alter their POMs or the time frames at which they were measured. Prospective registration with no changes in POMs occurred more frequently with pharmaceutical funding.

Discussion

Although standards are in place to improve prospective registration and transparency in clinical trials, less than 15% of psychiatry trials were prospectively registered with no changes in POMs. Most trials were either not prospectively registered, changed POMs or the timeframes at some point after registration or changed participant numbers. Authors, journal editors and reviewers need to further efforts to highlight the value of prospective trial registration.  相似文献   

13.
14.

Background

Sudden sensorineural hearing loss (SSNHL) is a relatively common condition that is usually of unknown etiology. A number of individual studies have investigated the association between various serum lipids and SSNHL; however, the findings have been inconsistent. In an attempt to obtain more definitive information on the relationship between serum lipids and SSNHL, we carried out a systematic review and meta-analysis.

Methods

Medline, the Cochrane Library, and EMBASE were searched using the following key words: lipid, cholesterol, triglyceride, fat, serum, blood, sudden hearing loss, hearing loss, hearing disorders. Randomized controlled trials, prospective cohort studies, and retrospective case-control studies involving patients with SSNHL and healthy controls that examined the relationship (reported as odds ratios [OR]) between lipid profiles and SSNHL were included. Primary outcomes were total cholesterol and low-density lipoprotein cholesterol (LDL-C) concentrations. Secondary outcomes were triglyceride, high-density lipoprotein cholesterol, and lipoprotein(a) concentrations.

Results

A total of 6 case-control studies were included in this systematic review/meta-analysis. The total number of participants ranged from 30 to 250 in the case group and from 43 to 271 in the control group. Meta-analysis revealed no significant difference in total cholesterol levels between the case and control groups (pooled OR = 1.79, 95% confidence interval [CI] = 0.98 to 3.26, P = 0.057). Likewise, meta-analysis revealed no significant difference in LDL-C concentrations between the case and control groups (pooled OR = 1.15, 95% CI = 0.64 to 2.07, P = 0.639). Since there were an insufficient number of studies reporting data for the secondary outcomes, meta-analysis was not possible.

Conclusions

Our results do not provide evidence for serum lipids being associated with SSNHL, nor do they definitively rule out such an association. Additional studies are needed to ascertain the relationship, or lack thereof, between serum lipids and SSNHL.  相似文献   

15.

Background

Reduced calorie, low fat diet is currently recommended diet for overweight and obese adults. Prior data suggest that low carbohydrate diets may also be a viable option for those who are overweight and obese.

Purpose

Compare the effects of low carbohydrate versus low fats diet on weight and atherosclerotic cardiovascular disease risk in overweight and obese patients.

Data Sources

Systematic literature review via PubMed (1966–2014).

Study Selection

Randomized controlled trials with ≥8 weeks follow up, comparing low carbohydrate (≤120gm carbohydrates/day) and low fat diet (≤30% energy from fat/day).

Data Extraction

Data were extracted and prepared for analysis using double data entry. Prior to identification of candidate publications, the outcomes of change in weight and metabolic factors were selected as defined by Cochrane Collaboration. Assessment of the effects of diets on predicted risk of atherosclerotic cardiovascular disease risk was added during the data collection phase.

Data Synthesis

1797 patients were included from 17 trials with <1 year follow up in 12. Compared with low fat diet, low carbohydrate was associated with significantly greater reduction in weight (Δ = -2.0 kg, 95% CI: -3.1, -0.9) and significantly lower predicted risk of atherosclerotic cardiovascular disease events (p<0.03). Frequentist and Bayesian results were concordant. The probability of greater weight loss associated with low carbohydrate was >99% while the reduction in predicted risk favoring low carbohydrate was >98%.

Limitations

Lack of patient-level data and heterogeneity in dropout rates and outcomes reported.

Conclusions

This trial-level meta-analysis of randomized controlled trials comparing LoCHO diets with LoFAT diets in strictly adherent populations demonstrates that each diet was associated with significant weight loss and reduction in predicted risk of ASCVD events. However, LoCHO diet was associated with modest but significantly greater improvements in weight loss and predicted ASCVD risk in studies from 8 weeks to 24 months in duration. These results suggest that future evaluations of dietary guidelines should consider low carbohydrate diets as effective and safe intervention for weight management in the overweight and obese, although long-term effects require further investigation.  相似文献   

16.

Background

We conducted this meta-analysis to compare the outcomes of coaxial microincision cataract surgery (C-MICS) and standard coaxial small incision cataract surgery (C-SICS).

Methods

The outcomes of randomized controlled trials (RCTs) reporting C-MICS and C-SICS were collected from PubMed, Web of Science, and The Cochrane Library in May 2015. The final meta-analysis was conducted on the following intraoperative and postoperative outcomes: ultrasound time (UST), effective phacoemulsification time (EPT), balanced salt solution use (BSS use), cumulative dissipated energy (CDE), mean surgery time, endothelial cell loss percentage (ECL%), best corrected visual acuity (BCVA), increased central corneal thickness (CCT), laser flare photometry values and surgically induced astigmatism (SIA).

Results

A total of 15 RCTs, involving 1136 eyes, were included in the final meta-analysis. No significant between-group differences were detected in EPT, BSS use, CDE, BCVA, laser flare photometry values or increased CCT. However, the C-MICS group showed less SIA (at postoperative day 7: p<0.01; at postoperative day 30 or more: p<0.01) and greater ECL% (at postoperative day 60 or more: p<0.01), whereas the C-SICS group required a shorter UST (p<0.01).

Conclusions

The present meta-analysis suggested that the C-MICS technique was more advantageous than C-SICS in terms of SIA, but C-MICS required a longer UST and induced a higher ECL%. Further studies should be done to confirm our results.  相似文献   

17.

Objectives

To identify and understand, through data from multiple sources, some of the factors that affect authors’ and editors’ decisions to use reporting guidelines in the publication of health research.

Design

Mixed methods study comprising an online survey and semi-structured interviews with a sample of authors (online survey: n = 56; response rate = 32%; semi-structured interviews: n = 5) and journal editors (online survey: n = 43; response rate = 27%; semi-structured interviews: n = 6) involved in publishing health and medical research. Participants were recruited from an earlier study examining the effectiveness of the TREND reporting guideline.

Results

Four types of factors interacted to affect authors’ and editors’ likelihood of reporting guideline use; individual (e.g. having multiple reasons for use of reporting guidelines); the professional culture in which people work; environmental (e.g. policies of journals); and, practical (e.g. having time to use reporting guidelines). Having multiple reasons for using reporting guidelines was a particularly salient factor in facilitating reporting guidelines use for both groups of participants.

Conclusions

Improving the completeness and consistency of reporting of research studies is critical to the integrity and synthesis of health research. The use of reporting guidelines offers one potentially efficient and effective means for achieving this, but decisions to use (or not use) reporting guidelines take many factors into account. These findings could be used to inform future studies that might, for example, test the factors that we have identified within a wider theoretical framework for understanding changes in professional practices. The use of reporting guidelines by senior professionals appears to shape the expectations of what constitutes best practice and can be assimilated into the culture of a field or discipline. Without evidence of effectiveness of reporting guidelines, and sustained, multifaceted efforts to improve reporting, little progress seems likely to be made.  相似文献   

18.

Introduction

Although selective reporting of clinical trial results introduces bias into evidence based clinical decision making, publication bias in pediatric epilepsy is unknown today. Since there is a considerable ambiguity in the treatment of an important and common clinical problem, pediatric seizures, we assessed the public availability of results of phase 3 clinical trials that evaluated treatments of seizures in children and adolescents as a surrogate for the extent of publication bias in pediatric epilepsy.

Methods

We determined the proportion of published and unpublished study results of phase 3 clinical trials that were registered as completed on ClinicalTrials.gov. We searched ClinicalTrials.gov, PubMed, and Google Scholar for publications and contacted principal investigators or sponsors. The analysis was performed according to STROBE criteria.

Results

Considering studies that were completed before 2014 (N = 99), 75 (76%) pediatric phase 3 clinical trials were published but 24 (24%) remained unpublished. The unpublished studies concealed evidence from 4,437 patients. Mean time-to-publication was 25 SD ± 15.6 months, more than twice as long as mandated.

Conclusion

Ten years after the ICMJE’s clinical trials registration initiative there is still a considerable amount of selective reporting and delay of publication that potentially distorts the body of evidence in the treatment of pediatric seizures.  相似文献   

19.

Objectives

To systematically review recidivism rates internationally, report whether they are comparable and, on the basis of this, develop best reporting guidelines for recidivism.

Methods

We searched MEDLINE, Google Web, and Google Scholar search engines for recidivism rates around the world, using both non-country-specific searches as well as targeted searches for the 20 countries with the largest total prison populations worldwide.

Results

We identified recidivism data for 18 countries. Of the 20 countries with the largest prison populations, only 2 reported repeat offending rates. The most commonly reported outcome was 2-year reconviction rates in prisoners. Sample selection and definitions of recidivism varied widely, and few countries were comparable.

Conclusions

Recidivism data are currently not valid for international comparisons. Justice Departments should consider using the reporting guidelines developed in this paper to report their data.  相似文献   

20.

Background

We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.

Methods

We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease. Trials were included if direct costs >$500,000/year, participants were adult humans, and the primary outcome was cardiovascular risk, disease or death. The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000, whether they registered in clinicaltrials.gov prior to publication, used active or placebo comparator, and whether or not the trial had industry co-sponsorship. We tabulated whether the study reported a positive, negative, or null result on the primary outcome variable and for total mortality.

Results

17 of 30 studies (57%) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 (8%) trials published after 2000 (χ2=12.2,df= 1, p=0.0005). There has been no change in the proportion of trials that compared treatment to placebo versus active comparator. Industry co-sponsorship was unrelated to the probability of reporting a significant benefit. Pre-registration in clinical trials.gov was strongly associated with the trend toward null findings.

Conclusions

The number NHLBI trials reporting positive results declined after the year 2000. Prospective declaration of outcomes in RCTs, and the adoption of transparent reporting standards, as required by clinicaltrials.gov, may have contributed to the trend toward null findings.  相似文献   

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