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The Article Alert for the week of April 7, 2014 (sample articles)
Norris SL, Holmer HK, Fu R, Ogden LA, Viswanathan MS, Abou-Setta AM. Clinical trial registries are of minimal use for identifying selective outcome and analysis reporting. Res.Synth.Method. Epub 2014 Mar 11.
Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR.
Study Design and Setting: We selected one “index outcome” for each of three comparative effectiveness reviews (CERs) of pharmacotherapy and extracted data on this outcome from trial registries and from study publications.
Results: Among 50 RCTs published since 2005 and reporting the index outcome, only 50% were listed in registries; 90% of RCTs were assessed as having SOR or SAR. The index outcome in the registry was different from that in the publication in 75% of trials in two CERs, and not specified at all in the third. Reported outcomes and analyses were not consistent between the publication's methods section and the results section in 33% and 46% of the two CERs where the index outcome was a benefit. There were no statistically significant predictors of SOR and SAR in our small sample where some predictors lacked variability.
Conclusion: The SOR and SAR were frequent in this pilot study, and the most common type of SOR was the publication of outcomes that were not pre-specified. Trial registries were of little use in identifying SOR and of no use in identifying SAR.
Copyright © 2014 John Wiley & Sons, Ltd.
Bafeta A, Trinquart L, Seror R, Ravaud P. Reporting of results from network meta-analyses: methodological systematic review. BMJ. 2014 Mar 11;348:g1741. PMID: 24618053.
OBJECTIVE: To examine how the results of network meta-analyses are reported.
DESIGN: Methodological systematic review of published reports of network meta-analyses.
DATA SOURCES: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Medline, and Embase, searched from inception to 12 July 2012.
STUDY SELECTION: All network meta-analyses comparing the clinical efficacy of three or more interventions in randomised controlled trials were included, excluding meta-analyses with an open loop network of three interventions.
DATA EXTRACTION AND SYNTHESIS: The reporting of the network and results was assessed. A composite outcome included the description of the network (number of interventions, direct comparisons, and randomised controlled trials and patients for each comparison) and the reporting of effect sizes derived from direct evidence, indirect evidence, and the network meta-analysis.
RESULTS: 121 network meta-analyses (55 published in general journals; 48 funded by at least one private source) were included. The network and its geometry (network graph) were not reported in 100 (83%) articles. The effect sizes derived from direct evidence, indirect evidence, and the network meta-analysis were not reported in 48 (40%), 108 (89%), and 43 (36%) articles, respectively. In 52 reports that ranked interventions, 43 did not report the uncertainty in ranking. Overall, 119 (98%) reports of network meta-analyses did not give a description of the network or effect sizes from direct evidence, indirect evidence, and the network meta-analysis. This finding did not differ by journal type or funding source.
CONCLUSIONS: The results of network meta-analyses are heterogeneously reported. Development of reporting guidelines to assist authors in writing and readers in critically appraising reports of network meta-analyses is timely.
- FREE FULL TEXT: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3949412/pdf/bmj.g1741.pdf
- DOI: http://dx.doi.org/10.1136/bmj.g1741
- PubMed Central: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3949412/
Copas J, Dwan K, Kirkham J, Williamson P. A model-based correction for outcome reporting bias in meta-analysis. Biostatistics. 2014 Apr;15(2):370-83. PMID: 24215031.
It is often suspected (or known) that outcomes published in medical trials are selectively reported. A systematic review for a particular outcome of interest can only include studies where that outcome was reported and so may omit, for example, a study that has considered several outcome measures but only reports those giving significant results. Using the methodology of the Outcome Reporting Bias (ORB) in Trials study of (Kirkham and others, 2010. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. British Medical Journal 340, c365), we suggest a likelihood-based model for estimating the effect of ORB on confidence intervals and p-values in meta-analysis. Correcting for bias has the effect of moving estimated treatment effects toward the null and hence more cautious assessments of significance. The bias can be very substantial, sometimes sufficient to completely overturn previous claims of significance. We re-analyze two contrasting examples, and derive a simple fixed effects approximation that can be used to give an initial estimate of the effect of ORB in practice.