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Pubmed vs. Full-Text Query Performance in Systematic Reviews : Application to Non-inferiority Clinical Trials
André Nguyen Van Nhieu1, 2, Katet Moez1, Michel Nougairede 2, Xavier Duval4, Michaël Schwarzinger1 1 ATIP-AVENIR Inserm “Modélisation, Aide à la Décision, et Coût-Efficacité en Maladie Infectieuses”, U738, Université Denis Diderot, Paris, France; 2 Département de Médecine Générale, Université Denis Diderot, Paris, France3 Inserm U738, Université Denis Diderot, Paris, France; 4 Inserm CIC 007, AP-HP, Hôpital Universitaire Bichat, Paris, France
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I declare no conflicts of interest
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Introduction (1)
Systematic review = extensive research of appropriate publications in the literature
Usually performed through Pubmed using key-words
Methodology appropriate when keywords in title/abstract and MeSH
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Introduction (2)
Comparison of Pubmed VS FULL-TEXT
Application: Non-inferiority trials in infectious diseases1
According to Piaggio CONSORT statement JAMA 2006: improving quality of reporting Non-inferiority trials
Hypothesis : Pubmed as sensitive as FULL-TEXT
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Objective
To compare the performance of 2 query strategies to identify non-inferiority trials with mortality as a primary outcome in infectious diseases: Pubmed Full-text using the search engine of each
journal
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Methods (1)
Original articles published in 2001-2012 In :
Generalist journals : N Engl J Med, Lancet, JAMA, Ann Intern Med, BMJ, Arch Intern Med
Specialist journals : Lancet Infectious Disease, Clinical Infectious Disease, Journal of Infectious Disease, AIDS, Vaccine, Pediatrics, PlosMed
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Methods (2)
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Using : PUBMED : keywords : [randomi* AND (non?
inferior* OR not inferior OR is inferior OR was inferior) AND (surviv* OR alive OR mortality OR death* OR fatal*)] + indexation (randomized controlled trial, Kaplan-Meier method, survival, mortality, death)
FULL-TEXT method with the same keywords adapted according to each search engine
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Methods (3)
Methods (4)
Definitions : True positive (TP): Non-inferiority trial (NIT) with
mortality as primary outcome found by one or the other query strategy
False positive (FP): Original article but it is not a NIT or a NIT with primary outcome ≠ mortality
False negative (FN): NIT fount by one query search but not the other
Positive predictive value (PPV): probability to find a TP among all Positive of a query strategy
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Results (1)
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Flowchart
Articles excluded (n=101):- 88 articles with survival as a secondary outcome- 13 articles with per protocol analysis
256 articles in infectious diseases identified in PUBMED
and FULL-TEXT : 81 in common and 175 more with
FULL-TEXT
Articles excluded (n= 28):- 28 NIT with outcome different from mortality
Articles excluded(N=72) : - 8 Reviews- 3 Observational studies - 17 Pooled analysis- 11 SUP RCT phase 2 - 23 SUP RCT phase 3 - 4 equivalence trials - 2 secondary analysis- 4 follow-up of NIT
184 Non-inferiority trials
156 Non-inferiority with mortality in the outcome
55 Non-inferiority with mortality as a primary outcome = TP
False positiveTrue positive
Results (2)
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FULL-TEXT
PUBMED Sensitivity Positive Predictive Value
55/55 (100%)
19/55 (34,5%)
55/256 (21,5%)
19/45 (42,2%)
False negative 0/55 (0%)
36/55 (65,5%)
Results (3)
Subgroup analysis : Sensitivity not different between
generalist / specialist journals (p=0,14) Sensitivity FULL-TEXT & Pubmed not
different <2008 / >2008 (p=0,07)
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Limits of FULL-TEXT method
1) Repetition in each journal search engine2) Specificity of each journal search engine :
learning curve3) Access to journals for GP is not free 4) Time consuming
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Conclusion (1)
FULL-TEXT is 100% sensitive Pubmed detects only 34,5% of non-
inferiority trials in infectious diseases High rate of false positive in FULL-TEXT However, False Positive easily identified
and excluded through reading
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Conclusion (2)
Testing the Full-text method in other medical fields or repeating in a few years (improving Pubmed?)
Improvement to be made with CONSORT statement
Adding Non-inferiority in MeSh terms
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THANK YOU
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Bibliography
Le Henanff et al. / RAVAUD Quality of Reporting of Noninferiority and Equivalence Randomized Trial JAMA 2010
Piaggio et al. Reporting of Noninferiority and Equivalence Randomized Trials JAMA 2006 and Extension of the CONSORT 2010 Statement JAMA 2012