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1.

Background

Treatment by covariate interactions can be explored in reviews using interaction analyses (e.g., subgroup analysis). Such analyses can provide information on how the covariate modifies the treatment effect and is an important methodological approach for personalising medicine. Guidance exists regarding how to apply such analyses but little is known about whether authors follow the guidance.

Methods

Using published recommendations, we developed criteria to assess how well interaction analyses were designed, applied, interpreted, and reported. The Cochrane Database of Systematic Reviews was searched (8th August 2013). We applied the criteria to the most recently published review, with an accessible protocol, for each Cochrane Review Group. We excluded review updates, diagnostic test accuracy reviews, withdrawn reviews, and overviews of reviews. Data were summarised regarding reviews, covariates, and analyses.

Results

Each of the 52 included reviews planned or did interaction analyses; 51 reviews (98%) planned analyses and 33 reviews (63%) applied analyses. The type of analysis planned and the type subsequently applied (e.g., sensitivity or subgroup analysis) was discrepant in 24 reviews (46%). No review reported how or why each covariate had been chosen; 22 reviews (42%) did state each covariate a priori in the protocol but no review identified each post-hoc covariate as such. Eleven reviews (21%) mentioned five covariates or less. One review reported planning to use a method to detect interactions (i.e., interaction test) for each covariate; another review reported applying the method for each covariate. Regarding interpretation, only one review reported whether an interaction was detected for each covariate and no review discussed the importance, or plausibility, of the results, or the possibility of confounding for each covariate.

Conclusions

Interaction analyses in Cochrane Reviews can be substantially improved. The proposed criteria can be used to help guide the reporting and conduct of analyses.  相似文献   

2.

Background

Meta-analyses conducted via the Cochrane Collaboration adhere to strict methodological and reporting standards aiming to minimize bias, maximize transparency/reproducibility, and improve the accuracy of summarized data. Whether this results in differences in the results reported by meta-analyses on the same topic conducted outside the Cochrane Collaboration is an open question.

Methods

We conducted a matched-pair analysis with individual meta-analyses as the unit of analysis, comparing Cochrane and non-Cochrane reviews. Using meta-analyses from the cardiovascular literature, we identified pairs that matched on intervention and outcome. The pairs were contrasted in terms of how frequently results disagreed between the Cochrane and non-Cochrane reviews, whether effect sizes and statistical precision differed systematically, and how these differences related to the frequency of secondary citations of those reviews.

Results

Our search yielded 40 matched pairs of reviews. The two sets were similar in terms of which was first to publication, how many studies were included, and average sample sizes. The paired reviews included a total of 344 individual clinical trials: 111 (32.3%) studies were included only in a Cochrane review, 104 (30.2%) only in a non-Cochrane review, and 129 (37.5%) in both. Stated another way, 62.5% of studies were only included in one or the other meta-analytic literature. Overall, 37.5% of pairs had discrepant results. The most common involved shifts in the width of 95% confidence intervals that would yield a different statistical interpretation of the significance of results (7 pairs). Additionally, 20% differed in the direction of the summary effect size (5 pairs) or reported greater than a 2-fold difference in its magnitude (3 pairs). Non-Cochrane reviews reported significantly higher effect sizes (P< 0.001) and lower precision (P<0.001) than matched Cochrane reviews. Reviews reporting an effect size at least 2-fold greater than their matched pair were cited more frequently.

Conclusion

Though results between topic-matched Cochrane and non-Cochrane reviews were quite similar, discrepant results were frequent, and the overlap of included studies was surprisingly low. Non-Cochrane reviews report larger effect sizes with lower precision than Cochrane reviews, indicating systematic differences, likely reflective of methodology, between the two types of reviews that could generate different interpretations of the interventions under question.  相似文献   

3.

Background

Comprehensive monitoring of the quality of systematic reviews (SRs) and meta-analyses (MAs) of endoscopic ultrasound (EUS) requires complete and accurate reporting and methodology.

Objective

To assess the reporting and methodological quality of SRs/MAs on EUS diagnosis and to explore the potential factors influencing articles’ quality.

Methods

The quality of the reporting and methodology was evaluated in relation to the adherence of papers to the PRISMA checklist and the AMSTAR quality scale. The total scores for every criterion and for every article on the two standards were calculated. Data were evaluated and analyzed using SPSS17.0 and RevMan 5.1 in terms of publication time, category of reviews, category of journals, and funding resource.

Results

A total of 72 SRs/MAs was included, but no Cochrane Systematic Reviews (CSRs) were obtained. The number of SRs/MAs ranged from 1 in 1998 to 15 in 2013; 88.1% used the QUADAS tool; the average overall scores by PRISMA statement and AMSTAR tool were 19.9 and 5.4, respectively. Scores on some items showed substantial improvement after publication of PRISMA and AMSTAR. However, no reviews followed the criterion of protocol and registration, and only 11.1% of articles fulfilled the criterion of literature search. SRs/MAs from the Science Citation Index (SCI) were of better quality than non-SCI studies. Funding resource made no difference to quality. Regression analysis showed that time of publication and inclusion in the SCI were significantly correlated with total scores on the two standards.

Conclusion

The reporting and methodological quality of SRs/MAs on EUS diagnosis has improved measurably since PRISMA and AMSTAR checklists released. It is hoped that CSR in this field will be produced. Literature searching and protocol criteria, as well as QUADAS-2 tool need to be addressed more in the future. Time of publication and SCI relate more to the overall quality of SRs/MAs than does funding resource.  相似文献   

4.

Objectives

To assess discrepancies in the analyzed outcomes between protocols and published reviews within Cochrane oral health systematic reviews (COHG) on the Cochrane Database of Systematic Reviews (CDSR).

Study Design and Setting

All COHG systematic reviews on the CDSR and the corresponding protocols were retrieved in November 2014 and information on the reported outcomes was recorded. Data was collected at the systematic review level by two reviewers independently.

Results

One hundred and fifty two reviews were included. In relation to primary outcomes, 11.2% were downgraded to secondary outcomes, 9.9% were omitted altogether in the final publication and new primary outcomes were identified in 18.4% of publications. For secondary outcomes, 2% were upgraded to primary, 12.5% were omitted and 30.9% were newly introduced in the publication. Overall, 45.4% of reviews had at least one discrepancy when compared to the protocol; these were reported in 14.5% reviews. The number of review updates appears to be associated with discrepancies between final review and protocol (OR: 3.18, 95% CI: 1.77, 5.74, p<0.001). The risk of reporting significant results was lower for both downgraded outcomes [RR: 0.52, 95% CI: 0.17, 1.58, p = 0.24] and upgraded or newly introduced outcomes [RR: 0.77, 95% CI: 0.36, 1.64, p = 0.50] compared to outcomes with no discrepancies. The risk of reporting significant results was higher for upgraded or newly introduced outcomes compared to downgraded outcomes (RR = 1.19, 95% CI: 0.65, 2.16, p = 0.57). None of the comparisons reached statistical significance.

Conclusion

While no evidence of selective outcome reporting was found in this study, based on the present analysis of SRs published within COHG systematic reviews, discrepancies between outcomes in pre-published protocols and final reviews continue to be common. Solutions such as the use of standardized outcomes to reduce the prevalence of this issue may need to be explored.  相似文献   

5.

Background

It is possible that cross-over studies included in current systematic reviews are being inadequately assessed, because the current risk of bias tools do not consider possible biases specific to cross-over design. We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Reviews (CSRs).

Methods

We searched the Cochrane Library (up to 2013 issue 5) for CSRs that included at least one cross-over trial. Two authors independently undertook the study selection and data extraction. A random sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane handbook. In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane handbook.

Results

We identified 688 CSRs that included one or more cross-over studies. We chose a random sample of 60 CSRs and these included 139 cross-over studies. None of these CSRs undertook a risk of bias assessment specific for cross-over studies. In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs. When we reassessed the risk of bias, including the 3 items specific to cross-over trials, of these 139 studies, a low risk of bias was judged for appropriate cross-over design in 110(79%), carry-over effects in 48(34%) and for reporting data in all stages of the trial in 114(82%).Assessment of biases in cross-over trials could affect the GRADE assessment of a review’s findings.

Conclusion

The current Cochrane risk of bias tool is not adequate to assess cross-over studies. Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs. A proposed check list for the evaluation of cross-over trials is provided.  相似文献   

6.

Objective

Acupuncture is commonly practiced in Korea and is regularly evaluated in clinical trials. Although many Cochrane reviews of acupuncture include searches of both English and Chinese databases, there is no information on the value of searching Korean databases. This study aimed to investigate the impact of searching Korean databasesand journals for trials eligible for inclusion in existing Cochrane acupuncture reviews.

Methods

We searched 12 Korean databases and seven Korean journals to identify randomised trials meeting the inclusion criteria for acupuncture reviews in the Cochrane Database of Systematic Reviews. We compared risk of bias assessments of the Korean trials with the trials included in the Cochrane acupuncture reviews. Where possible, we added data from the Korean trials to the existing meta-analyses in the relevant Cochrane review and conducted sensitivity analyses to test the robustness of the results.

Results

Sixteen Korean trials (742 participants) met the inclusion criteria for eight Cochrane acupuncture reviews (125 trials; 13,041 participants). Inclusion of the Korean trials provided data for 20% of existing meta-analyses (24 out of 120). Inclusion of the Korean trials did not change the direction of effect in any of the existing meta-analyses. The effect size and heterogeneity remained mostly unchanged. In only one meta-analysis did the significance change. Compared to the studies included in the Cochrane acupuncture reviews, the risk of bias in the Korean trials was higher in terms of outcome assessor blinding and allocation concealment.

Conclusions

Many Korean studies contributed additional data to the existing meta-analyses in Cochrane acupuncture reviews. Although inclusion of these studies did not alter the results of the meta-analyses, comprehensive searches of the literature are important to avoid potential language bias. The identification and inclusion of eligible Korean trials should be considered for reviews of acupuncture.  相似文献   

7.

Background

Chronic migraine is a debilitating headache disorder that has significant impact on quality of life. Stimulation of peripheral nerves is increasingly being used to treat chronic refractory pain including headache disorders. This systematic review examines the effectiveness and adverse effects of occipital nerve stimulation (ONS) for chronic migraine.

Methods

Databases, including the Cochrane Library, MEDLINE, EMBASE, CINAHL and clinical trial registers were searched to September 2014. Randomized controlled trials (RCTs), other controlled and uncontrolled observational studies and case series (n≥ 10) were eligible. RCTs were assessed using the Cochrane risk of bias tool. Meta-analysis was carried out using a random-effects model. Findings are presented in summary tables and forest plots.

Results

Five RCTs (total n=402) and seven case series (total n=115) met the inclusion criteria. Pooled results from three multicenter RCTs show that ONS was associated with a mean reduction of 2.59 days (95% CI 0.91 to 4.27, I2=0%) of prolonged, moderate to severe headache per month at 3 months compared with a sham control. Results for other outcomes generally favour ONS over sham controls but quantitative analysis was hampered by incomplete publication and reporting of trial data. Lead migration and infections are common and often require revision surgery. Open-label follow-up of RCTs and case series suggest long-term effectiveness can be maintained in some patients but evidence is limited.

Conclusions

While the effectiveness of ONS compared to sham control has been shown in multiple RCTs, the average effect size is modest and may be exaggerated by bias as achieving effective blinding remains a methodological challenge. Further measures to reduce the risk of adverse events and revision surgery are needed.

Systematic Review Registration

this systematic review is an update and expanded work of part of a broader review registered with PROSPERO. Registration No. CRD42012002633.  相似文献   

8.

Background

Non-surgical interventions for adolescents with idiopathic scoliosis remain highly controversial. Despite the publication of numerous reviews no explicit methodological evaluation of papers labeled as, or having a layout of, a systematic review, addressing this subject matter, is available.

Objectives

Analysis and comparison of the content, methodology, and evidence-base from systematic reviews regarding non-surgical interventions for adolescents with idiopathic scoliosis.

Design

Systematic overview of systematic reviews.

Methods

Articles meeting the minimal criteria for a systematic review, regarding any non-surgical intervention for adolescent idiopathic scoliosis, with any outcomes measured, were included. Multiple general and systematic review specific databases, guideline registries, reference lists and websites of institutions were searched. The AMSTAR tool was used to critically appraise the methodology, and the Oxford Centre for Evidence Based Medicine and the Joanna Briggs Institute’s hierarchies were applied to analyze the levels of evidence from included reviews.

Results

From 469 citations, twenty one papers were included for analysis. Five reviews assessed the effectiveness of scoliosis-specific exercise treatments, four assessed manual therapies, five evaluated bracing, four assessed different combinations of interventions, and one evaluated usual physical activity. Two reviews addressed the adverse effects of bracing. Two papers were high quality Cochrane reviews, Three were of moderate, and the remaining sixteen were of low or very low methodological quality. The level of evidence of these reviews ranged from 1 or 1+ to 4, and in some reviews, due to their low methodological quality and/or poor reporting, this could not be established.

Conclusions

Higher quality reviews indicate that generally there is insufficient evidence to make a judgment on whether non-surgical interventions in adolescent idiopathic scoliosis are effective. Papers labeled as systematic reviews need to be considered in terms of their methodological rigor; otherwise they may be mistakenly regarded as high quality sources of evidence.

Protocol registry number

CRD42013003538, PROSPERO  相似文献   

9.

Background

In patients with immune-mediated inflammatory disorders, poor adherence to medication is associated with increased healthcare costs, decreased patient satisfaction, reduced quality of life and unfavorable treatment outcomes.

Objective

To determine the impact of different interventions on medication adherence in patients with immune-mediated inflammatory disorders.

Design

Systematic review.

Data sources

MEDLINE, EMBASE and Cochrane Library.

Study eligibility criteria for selecting studies

Included studies were clinical trials and observational studies in adult outpatients treated for psoriasis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or multiple sclerosis.

Study appraisal and synthesis methods

Intervention approaches were classified into four categories: educational, behavioral, cognitive behavioral, and multicomponent interventions. The risk of bias/study limitations of each study was assessed using the GRADE system.

Results

Fifteen studies (14 clinical trials and one observational study) met eligibility criteria and enrolled a total of 1958 patients. Forty percent of the studies (6/15) was conducted in patients with inflammatory bowel disease, half (7/15) in rheumatoid arthritis patients, one in psoriasis patients and one in multiple sclerosis patients. Seven out of 15 interventions were classified as multicomponent, four as educational, two as behavioral and two as cognitive behavioral. Nine studies, of which five were multicomponent interventions, had no serious limitations according to GRADE criteria. Nine out of 15 interventions showed an improvement of adherence: three multicomponent interventions in inflammatory bowel disease; one intervention of each category in rheumatoid arthritis; one multicomponent in psoriasis and one multicomponent in multiple sclerosis.

Conclusion

The assessment of interventions designed for increasing medication adherence in IMID is rare in the literature and their methodological quality may be improved in upcoming studies. Nonetheless, multicomponent interventions showed the strongest evidence for promoting adherence in patients with IMID.  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.
12.

Objective

This systematic review sought to assess the costs and benefits of interventions preventing hospital-acquired infections and to evaluate methodological and reporting quality.

Methods

We systematically searched Medline via PubMed and the National Health Service Economic Evaluation Database from 2009 to 2014. We included quasi-experimental and randomized trails published in English or German evaluating the economic impact of interventions preventing the four most frequent hospital-acquired infections (urinary tract infections, surgical wound infections, pneumonia, and primary bloodstream infections). Characteristics and results of the included articles were extracted using a standardized data collection form. Study and reporting quality were evaluated using SIGN and CHEERS checklists. All costs were adjusted to 2013 US$. Savings-to-cost ratios and difference values with interquartile ranges (IQRs) per month were calculated, and the effects of study characteristics on the cost-benefit results were analyzed.

Results

Our search returned 2067 articles, of which 27 met the inclusion criteria. The median savings-to-cost ratio across all studies reporting both costs and savings values was US $7.0 (IQR 4.2–30.9), and the median net global saving was US $13,179 (IQR 5,106–65,850) per month. The studies’ reporting quality was low. Only 14 articles reported more than half of CHEERS items appropriately. Similarly, an assessment of methodological quality found that only four studies (14.8%) were considered high quality.

Conclusions

Prevention programs for hospital acquired infections have very positive cost-benefit ratios. Improved reporting quality in health economics publications is required.  相似文献   

13.

Background

Failure to recognize acute deterioration in hospitalized patients may contribute to cardiopulmonary arrest, unscheduled intensive care unit admission and increased mortality.

Purpose

In this systematic review we aimed to determine whether continuous non-invasive respiratory monitoring improves early diagnosis of patient deterioration and reduces critical incidents on hospital wards.

Data Sources

Studies were retrieved from Medline, Embase, CINAHL, and the Cochrane library, searched from 1970 till October 25, 2014.

Study Selection

Electronic databases were searched using keywords and corresponding synonyms ‘ward’, ‘continuous’, ‘monitoring’ and ‘respiration’. Pediatric, fetal and animal studies were excluded.

Data Extraction

Since no validated tool is currently available for diagnostic or intervention studies with continuous monitoring, methodological quality was assessed with a modified tool based on modified STARD, CONSORT, and TREND statements.

Data Synthesis

Six intervention and five diagnostic studies were included, evaluating the use of eight different devices for continuous respiratory monitoring. Quantitative data synthesis was not possible because intervention, study design and outcomes differed considerably between studies. Outcomes estimates for the intervention studies ranged from RR 0.14 (0.03, 0.64) for cardiopulmonary resuscitation to RR 1.00 (0.41, 2.35) for unplanned ICU admission after introduction of continuous respiratory monitoring,

Limitations

The methodological quality of most studies was moderate, e.g. ‘before-after’ designs, incomplete reporting of primary outcomes, and incomplete clinical implementation of the monitoring system.

Conclusions

Based on the findings of this systematic review, implementation of routine continuous non-invasive respiratory monitoring on general hospital wards cannot yet be advocated as results are inconclusive, and methodological quality of the studies needs improvement. Future research in this area should focus on technology explicitly suitable for low care settings and tailored alarm and treatment algorithms.  相似文献   

14.

Background

Breast and cervical cancers have emerged as major global health challenges and disproportionately lead to excess morbidity and mortality in low- and middle-income countries (LMICs) when compared to high-income countries. The objective of this paper was to highlight key findings, recommendations, and gaps in research and practice identified through a scoping study of recent reviews in breast and cervical cancer in LMICs.

Methods

We conducted a scoping study based on the six-stage framework of Arskey and O’Malley. We searched PubMed, Cochrane Reviews, and CINAHL with the following inclusion criteria: 1) published between 2005-February 2015, 2) focused on breast or cervical cancer 3) focused on LMIC, 4) review article, and 5) published in English.

Results

Through our systematic search, 63 out of the 94 identified cervical cancer reviews met our selection criteria and 36 of the 54 in breast cancer. Cervical cancer reviews were more likely to focus upon prevention and screening, while breast cancer reviews were more likely to focus upon treatment and survivorship. Few of the breast cancer reviews referenced research and data from LMICs themselves; cervical cancer reviews were more likely to do so. Most reviews did not include elements of the PRISMA checklist.

Conclusion

Overall, a limited evidence base supports breast and cervical cancer control in LMICs. Further breast and cervical cancer prevention and control studies are necessary in LMICs.  相似文献   

15.

Purpose

Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates.

Methods

Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received.

Results

40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower.

Conclusions

Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be considered when designing future exercise-oncology trials.  相似文献   

16.

Background

The QUOROM and PRISMA statements were published in 1999 and 2009, respectively, to improve the consistency of reporting systematic reviews (SRs)/meta-analyses (MAs) of clinical trials. However, not all SRs/MAs adhere completely to these important standards. In particular, it is not clear how well SRs/MAs of acupuncture studies adhere to reporting standards and which reporting criteria are generally ignored in these analyses.

Objectives

To evaluate reporting quality in SRs/MAs of acupuncture studies.

Methods

We performed a literature search for studies published prior to 2014 using the following public archives: PubMed, EMBASE, Web of Science, the Cochrane Database of Systematic Reviews (CDSR), the Chinese Biomedical Literature Database (CBM), the Traditional Chinese Medicine (TCM) database, the Chinese Journal Full-text Database (CJFD), the Chinese Scientific Journal Full-text Database (CSJD), and the Wanfang database. Data were extracted into pre-prepared Excel data-extraction forms. Reporting quality was assessed based on the PRISMA checklist (27 items).

Results

Of 476 appropriate SRs/MAs identified in our search, 203, 227, and 46 were published in Chinese journals, international journals, and the Cochrane Database, respectively. In 476 SRs/MAs, only 3 reported the information completely. By contrast, approximately 4.93% (1/203), 8.81% (2/227) and 0.00% (0/46) SRs/Mas reported less than 10 items in Chinese journals, international journals and CDSR, respectively. In general, the least frequently reported items (reported≤50%) in SRs/MAs were “protocol and registration”, “risk of bias across studies”, and “additional analyses” in both methods and results sections.

Conclusions

SRs/MAs of acupuncture studies have not comprehensively reported information recommended in the PRISMA statement. Our study underscores that, in addition to focusing on careful study design and performance, attention should be paid to comprehensive reporting standards in SRs/MAs on acupuncture studies.  相似文献   

17.

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   

18.

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   

19.
Randomized crossover trials are clinical experiments in which participants are assigned randomly to a sequence of treatments and each participant serves as his/her own control in estimating treatment effect. We need a better understanding of the validity of their results to enable recommendations as to which crossover trials can be included in meta-analysis and for development of reporting guidelines.

Objective

To evaluate the characteristics of the design, analysis, and reporting of crossover trials for inclusion in a meta-analysis of treatment for primary open-angle glaucoma and to provide empirical evidence to inform the development of tools to assess the validity of the results from crossover trials and reporting guidelines.

Methods

We searched MEDLINE, EMBASE, and Cochrane’s CENTRAL register for randomized crossover trials for a systematic review and network meta-analysis we are conducting. Two individuals independently screened the search results for eligibility and abstracted data from each included report.

Results

We identified 83 crossover trials eligible for inclusion. Issues affecting the risk of bias in crossover trials, such as carryover, period effects and missing data, were often ignored. Some trials failed to accommodate the within-individual differences in the analysis. For a large proportion of the trials, the authors tabulated the results as if they arose from a parallel design. Precision estimates properly accounting for the paired nature of the design were often unavailable from the study reports; consequently, to include trial findings in a meta-analysis would require further manipulation and assumptions.

Conclusions

The high proportion of poorly reported analyses and results has the potential to affect whether crossover data should or can be included in a meta-analysis. There is pressing need for reporting guidelines for crossover trials.  相似文献   

20.

Background

Metamizole is used to treat pain in many parts of the world. Information on the safety profile of metamizole is scarce; no conclusive summary of the literature exists.

Objective

To determine whether metamizole is clinically safe compared to placebo and other analgesics.

Methods

We searched CENTRAL, MEDLINE, EMBASE, CINAHL, and several clinical trial registries. We screened the reference lists of included trials and previous systematic reviews. We included randomized controlled trials that compared the effects of metamizole, administered to adults in any form and for any indication, to other analgesics or to placebo. Two authors extracted data regarding trial design and size, indications for pain medication, patient characteristics, treatment regimens, and methodological characteristics. Adverse events (AEs), serious adverse events (SAEs), and dropouts were assessed. We conducted separate meta-analyses for each metamizole comparator, using standard inverse-variance random effects meta-analysis to pool the estimates across trials, reported as risk ratios (RRs). We calculated the DerSimonian and Laird variance estimate T2 to measure heterogeneity between trials. The pre-specified primary end point was any AE during the trial period.

Results

Of the 696 potentially eligible trials, 79 trials including almost 4000 patients with short-term metamizole use of less than two weeks met our inclusion criteria. Fewer AEs were reported for metamizole compared to opioids, RR = 0.79 (confidence interval 0.79 to 0.96). We found no differences between metamizole and placebo, paracetamol and NSAIDs. Only a few SAEs were reported, with no difference between metamizole and other analgesics. No agranulocytosis or deaths were reported. Our results were limited by the mediocre overall quality of the reports.

Conclusion

For short-term use in the hospital setting, metamizole seems to be a safe choice when compared to other widely used analgesics. High-quality, adequately sized trials assessing the intermediate- and long-term safety of metamizole are needed.  相似文献   

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