Evidence map›Paper›PMID 25336990›Full record

ArticleClinical epidemiology2014

Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle-Ottawa Scale and the RTI item bank.

Andrea V Margulis, Manel Pladevall, Nuria Riera-Guardia, Cristina Varas-Lorenzo, Lorna Hazell, Nancy D Berkman, Meera Viswanathan, Susana Perez-Gutthann

Abstract read
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In one paragraph

Article in Clinical epidemiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 258 papers, 121 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
258citing papers in PubMed, 121 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

258 citing papers in PubMed, 121 syntheses or guidelines pooled it.

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  6. C-reactive protein and its ratio with albumin as a marker of poor prognosis in oral cancer: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
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198 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Andrea V MargulisRTI Health Solutions, Barcelona, Spain.
Manel PladevallRTI Health Solutions, Barcelona, Spain.
Nuria Riera-GuardiaRTI Health Solutions, Barcelona, Spain.
Cristina Varas-LorenzoRTI Health Solutions, Barcelona, Spain.
Lorna HazellDrug Safety Research Unit, Southampton, UK ; Associate Department of the School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, UK.
Nancy D BerkmanRTI International, Research Triangle Park, NC, USA.
Meera ViswanathanRTI International, Research Triangle Park, NC, USA.
Susana Perez-GutthannRTI Health Solutions, Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe study objective was to compare the Newcastle-Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs.

methodsWe tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic.

resultsThe NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86).

conclusionThe RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB's developers.

Indexed as

AC1meta-analysisquality assessmentsystematic review

Identifiers

PMID25336990
PMCPMC4199858

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.