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Metabias: A Challenge for Comparative Effectiveness Research

2011; American College of Physicians; Volume: 155; Issue: 1 Linguagem: Inglês

10.7326/0003-4819-155-1-201107050-00010

1539-3704

Steven N. Goodman, Kay Dickersin,

Pharmaceutical industry and healthcare

Editorials5 July 2011Metabias: A Challenge for Comparative Effectiveness ResearchSteven Goodman, MD, MHS, PhD and Kay Dickersin, MA, PhDSteven Goodman, MD, MHS, PhDFrom Johns Hopkins University, Baltimore, MD 21205.Search for more papers by this author and Kay Dickersin, MA, PhDFrom Johns Hopkins University, Baltimore, MD 21205.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-1-201107050-00010 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Comparative effectiveness research encompasses both individual primary research studies and syntheses of the primary research, typically systematic reviews and meta-analyses. Before accepting the results of either form of study, decision makers must critically assess their methods to identify sources of potential bias.For primary research, critical appraisal involves close examination of research methods, including design, data, execution, analysis, and interpretation. For meta-analyses, individual studies are examined in the same way, but the collection of studies is also examined for heterogeneity. Studies are deemed heterogeneous if their methods or results differ from one another so much that the studies cannot be ...References1. Egger M, Juni P, Bartlett C, Holenstein F, Sterne J. How important are comprehensive literature searches and the assessment of trial quality in systematic reviews? Empirical study. Health Technol Assess. 2003;7:1-76. [PMID: 12583822] CrossrefMedlineGoogle Scholar2. Dickersin K, Chalmers I. Recognising, investigating and dealing with incomplete and biased reporting of clinical research: from Francis Bacon to the World Health Organisation. Accessed at www.jameslindlibrary.org/essays/biased_reporting/biased_reporting.html on 23 May 2011. Google Scholar3. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev. 2009;:MR000006. [PMID: 19160345] MedlineGoogle Scholar4. Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011;:MR000031. [PMID: 21249714] MedlineGoogle Scholar5. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess. 2010;14:iii, ix-xi, 1-193. [PMID: 20181324] CrossrefMedlineGoogle Scholar6. Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361:1963-71. [PMID: 19907043] CrossrefMedlineGoogle Scholar7. Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291:2457-65. [PMID: 15161896] CrossrefMedlineGoogle Scholar8. Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies [Editorial]. JAMA. 2005;294:110-1. [PMID: 15998899] CrossrefMedlineGoogle Scholar9. Eyding D, Lelgemann M, Grouven U, Härter M, Kromp M, Kaiser T, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. [PMID: 20940209] CrossrefMedlineGoogle Scholar10. McGauran N, Wieseler B, Kreis J, Schüler YB, Kölsch H, Kaiser T. Reporting bias in medical research—a narrative review. Trials. 2010;11:37. [PMID: 20388211] CrossrefMedlineGoogle Scholar11. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167-70. [PMID: 12775614] CrossrefMedlineGoogle Scholar12. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003;290:921-8. [PMID: 12928469] CrossrefMedlineGoogle Scholar13. Gøtzsche PC. Research integrity and pharmaceutical industry sponsorship [Editorial]. Med J Aust. 2005;182:549-50. [PMID: 15938676] CrossrefMedlineGoogle Scholar14. Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290:516-23. [PMID: 12876095] CrossrefMedlineGoogle Scholar15. ClinicalTrials.gov. Protocol registration system. Accessed at prsinfo.clinicaltrials.gov/fdaaa.html on 23 May 2011. Google Scholar16. World Health Organization. International Clinical Trials Registry Platform (ICTRP). Accessed at www.who.int/ictrp/en/ on 23 May 2011. Google Scholar17. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database—update and key issues. N Engl J Med. 2011;364:852-60. [PMID: 21366476] CrossrefMedlineGoogle Scholar18. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al; International Committee of Medical Journal Editors. Clinical trial registration: a statement from the International Committee of Medical Journal Editors [Editorial]. JAMA. 2004;292:1363-4. [PMID: 15355936] CrossrefMedlineGoogle Scholar19. Dechartres A, Boutron I, Trinquart L, Charles P, Ravaud P. Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Ann Intern Med. 2011;155:39-51. LinkGoogle Scholar20. Dickersin K, Min YI. Publication bias: the problem that won't go away. Ann NY Acad Sci. 1993;703:135-46. [PMID: 8192291] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Steven Goodman, MD, MHS, PhD; Kay Dickersin, MA, PhDAffiliations: From Johns Hopkins University, Baltimore, MD 21205.Disclosures: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1186.Corresponding Author: Steven Goodman, MD, MHS, PhD, Johns Hopkins University, Oncology Biostatistics, 550 North Broadway, Suite 1103, Baltimore, MD 21205; e-mail, [email protected]edu.Current Author Addresses: Dr. Goodman: Johns Hopkins University, Oncology Biostatistics, 550 North Broadway, Suite 1103, Baltimore, MD 21205.Dr. Dickersin: Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205. 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