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Pubmed vs. Full-Text Query Performance in Systematic Reviews : Application to Non-inferiority Clinical Trials André Nguyen Van Nhieu 1, 2, Katet Moez 1, Michel Nougairede 2, Xavier Duval 4, Michaël Schwarzinger 1 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, France 3 Inserm U738, Université Denis Diderot, Paris, France; 4 Inserm CIC 007, AP-HP, Hôpital Universitaire Bichat, Paris, France 1

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I declare no conflicts of interest 2

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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 3

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Introduction (2) Comparison of Pubmed VS FULL-TEXT Application: Non-inferiority trials in infectious diseases 1 According to Piaggio CONSORT statement JAMA 2006: improving quality of reporting Non-inferiority trials Hypothesis : Pubmed as sensitive as FULL-TEXT 4

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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 5

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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 6

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Methods (2) 7

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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 10 Methods (3)

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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 11

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Results (1) 12 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 positive True positive

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Results (2) 13 FULL-TEXT PUBMEDSensitivityPositive 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%)

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Results (3) Subgroup analysis : Sensitivity not different between generalist / specialist journals (p=0,14) Sensitivity FULL-TEXT & Pubmed not different 2008 (p=0,07) 14

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Limits of FULL-TEXT method 1)Repetition in each journal search engine 2)Specificity of each journal search engine : learning curve 3)Access to journals for GP is not free 4)Time consuming 15

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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 16

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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 17

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THANK YOU 18

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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

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