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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

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  1. 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, France 3 Inserm U738, Université Denis Diderot, Paris, France; 4 Inserm CIC 007, AP-HP, Hôpital Universitaire Bichat, Paris, France

  2. I declare no conflicts of interest

  3. 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

  4. 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

  5. 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

  6. 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

  7. Methods (2)

  8. Methods (3) • 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

  9. 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

  10. Results (1) 256 articles in infectious diseases identified in PUBMED and FULL-TEXT : 81 in common and 175 more with FULL-TEXT 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 Articles excluded (n= 28): - 28 NIT with outcome different from mortality 156 Non-inferiority with mortality in the outcome Articles excluded (n=101): - 88 articles with survival as a secondary outcome - 13 articles with per protocol analysis 55 Non-inferiority with mortality as a primary outcome = TP Flowchart True positive False positive

  11. Results (2)

  12. 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)

  13. Limits of FULL-TEXT method • Repetition in each journal search engine • Specificity of each journal search engine : learning curve • Access to journals for GP is not free • Time consuming

  14. 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

  15. 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

  16. THANK YOU

  17. Bibliography • Le Henanff et al. / RAVAUD Quality of Reporting of Noninferiority and Equivalence Randomized TrialJAMA 2010 • Piaggio et al. Reporting of Noninferiority and Equivalence Randomized TrialsJAMA 2006 and Extension of the CONSORT 2010 StatementJAMA 2012

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