Dependability of results in conference abstracts of randomized controlled trials in ophthalmology and author financial conflicts of interest as a factor associated with full publication
Tóm tắt
Discrepancies between information in conference abstracts and full publications describing the same randomized controlled trial have been reported. The association between author conflicts of interest and the publication of randomized controlled trials is unclear. The objective of this study was to use randomized controlled trials in ophthalmology to evaluate (1) the agreement in the reported main outcome results by comparing abstracts and corresponding publications and (2) the association between the author conflicts of interest and publication of the results presented in the abstracts. We considered abstracts describing results of randomized controlled trials presented at the 2001–2004 Association for Research in Vision and Ophthalmology conferences as eligible for our study. Through electronic searching and by emailing abstract authors, we identified the earliest publication (journal article) containing results of each abstract’s main outcome through November 2013. We categorized the discordance between the main outcome results in the abstract and its paired publication as qualitative (a difference in the direction of the estimated effect) or as quantitative. We used the Association for Research in Vision and Ophthalmology categories for conflicts of interest: financial interest, employee of business with interest, consultant to business with interest, inventor/developer with patent, and receiving ≥ 1 gift from industry in the past year. We calculated the relative risks (RRs) of publication associated with the categories of conflicts of interest for abstracts with results that were statistically significant, not statistically significant, or not reported. We included 513 abstracts, 230 (44.8 %) of which reached publication. Among the 86 pairs with the same main outcome domain at the same time point, 47 pairs (54.7 %) had discordant results: qualitative discordance in 7 pairs and quantitative discordance in 40 pairs. Quantitative discordance was indicated as < 10, 10–20, > 20 %, and unclear in 14, 5, 14, and 7 pairs, respectively. First authors reporting of one or more conflicts of interest was associated with a greater likelihood of publication (RR = 1.31; 95 % CI = 1.04 to 1.64) and a shorter time-to-publication (log-rank p = 0.026). First author conflicts of interests that were associated with publication were financial support (RR = 1.50; 95 % CI = 1.19 to 1.90) and one or more gifts (RR = 1.42; 95 % CI = 1.05 to 1.92). The association between conflicts of interest and publication remained, irrespective of the statistical significance of the results. More than half the abstract/publication pairs exhibited some amount of discordance in the main outcome results, calling into question the dependability of conference abstracts. Regardless of the main outcome results, the conflicts of interests of the abstract’s first author were associated with publication.
Tài liệu tham khảo
Weintraub WH. Are published manuscripts representative of the surgical meeting abstracts? an objective appraisal. J Pediatr Surg. 1987;22:11–3.
Gross CP, Steiner CA, Bass EB, Powe NR. Relation between prepublication release of clinical trial results and the practice of carotid endarterectomy. JAMA. 2000;284:2886–93.
Falagas ME, Rosmarakis ES. Clinical decision-making based on findings presented in conference abstracts: is it safe for our patients? Eur Heart J. 2006;27(17):2038–9.
Institute of Medicine. Finding what works in health care: standards for systematic reviews. March 23, 2011 – available for download as PDF free of charge online at: http://www.iom.edu/Reports/2011/Finding-What-Works-in-Health-Care-Standards-for-Systematic-Reviews.aspx. Accessed 28 Mar 2016.
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration; 2011. Available: www.cochrane-handbook.org. Accessed 28 Mar 2016.
Methods Guide for Effectiveness and Comparative Effectiveness Reviews. AHRQ Publication No. 10(14)-EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality. January 2014. Chapters available at: www.effectivehealthcare.ahrq.gov. Accessed 28 Mar 2016.
Center for Reviews and Dissemination. Systematic reviews: CRD’s guidance for undertaking reviews in health care. York, UK: York Publishing Services, Ltd. Available at: https://www.york.ac.uk/media/crd/Systematic_Reviews.pdf. Accessed 28 Mar 2016.
Dundar Y, Dodd S, Dickson R, Walley T, Haycox A, Williamson PR. Comparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies. Health Technol Assess. 2006;10(5):iii-iv–x-145.
Dwan K, Altman DG, Creswell 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;19(1):MR000031. doi:10.1002/14651858.MR000031.pub2.
Dwan K, Gamble C, Williamson PR, Kirkham JJ, Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias – an updated review. PLoS One. 2013;8(7):e66844. doi:10.1371/journal.pone.0066844.
Scherer RW, Huynh L, Ervin A-M, Dickersin K. Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study. PLoS One. 2015;10(6):e0130619. doi:10.1371/journal.pone.0130619.
Bhandari M, Devereaux PJ, Guyatt GH, Cook DJ, Swiontkowski MF, Sprague S, et al. An observational study of orthopaedic abstracts and subsequent full-text publications. J Bone Joint Surg Am. 2002;84-A:615–21.
Kleweno CP, Bryant WK, Jacir AM, Levine WN, Ahmad CS. Discrepancies and rates of publication in orthopedic sports medicine abstracts. Am J Sports Med. 2008;36(10):1875–9.
Toma M, McAlister FA, Bialy L, Adams D, Vandermeer B, Armstrong PW. Transition from meeting abstract to full-length journal article for randomized controlled trials. JAMA. 2006;295:1281–7.
Klassen TP, Wiebe N, Russell K, Stevens K, Hartling L, Craig WR, et al. Abstracts of randomized controlled trials presented at the society for pediatric research meeting: an example of publication bias. Arch Pediatr Adolesc Med. 2002;156:474–9.
Rosmarakis ES, Soteriades ES, Vergidis PI, Kasiakou SK, Falagas ME. From conference abstract to full paper: differences between data presented in conferences and journals. FASEB J. 2005;19:673–80.
Chokkalingam A, Scherer R, Dickersin K. Agreement of data abstracts compared to full publications. Control Clin Trials. 1998;19:61S–2.
Scherer RW, Ugarte-Gil C, Schmucker C, Meerpohl JJ. Authors report lack of time as main reason for unpublished research presented at biomedical conferences: a systematic review. J Clin Epidemiol. 2015. doi:10.1016/j.jclinepi.2015.01.027.
Song F, Parekh S, Hooper L, Loke Y, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an update of related biases. Health Technol Assess. 2010;14(8):iii. doi:10.3310/hta14080. ix-xi, 1-193.
Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev. 2007;2:MR000005. doi:10.1002/14651858.MR000005.pub3.
Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance of direction of trial result. Cochrane Database Syst Rev. 2009;1:MR000006.
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289(4):454–65.
Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–60.
Sismondo S. Pharmaceutical company funding and its consequences: a qualitative systematic review. Contemporay Clinical Trials. 2008;29(2):109–13.
Lundh A, Sismondo S, Lexchin J, Busuioc OA, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2012;12:MR000033. doi:10.1002/14651858.MR000033.pub2.
Thompson D. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573–6.
International Committee of Medical Journal Editors (ICMJE). Author responsibilities-Conflicts of interest. Available at http://www.icmje.org/recommendations/browse/roles-and-responsibilities/author-responsibilities--conflicts-of-interest.html. Accessed 28 Mar 2016.
Bland JM, Altman DG. The logrank test. BMJ. 2004;328(7447):1073.
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66.
Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86–9.
Macleod MR, Michie S, Roberts I, Dirnagl U, Chalmers I, Ioannidis JP, et al. Biomedical research: increasing value, reducing waste. Lancet. 2014;383(9912):101–4.
Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990;263:1405–8.
Antes G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet. 2003;361:978–9.
von Elm E, Costanza MC, Walder B, Tramèr MR. More insight into the fate of biomedical meeting abstracts: a systematic review. BMC Med Res Methodol. 2003;3(1):12.
Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371(9609):281–3.
Ghimire S, Kyung E, Kang W, Kim E. Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals. Trials. 2012;13:77. doi:10.1186/1745-6215-13-77.
Sivendran S, Newport K, Horst M, Albert A, Galsky MD. Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies. Trials. 2015;16:341. doi:10.1186/s13063-015-0885-9.
Wang L, Li Y, Li J, Zhang M, Xu L, Yuan W, et al. Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials. 2010;11:75. doi:10.1186/1745-6215-11-75.
Korevaar DA, Cohen JF, de Ronde MW, Virgili G, Dickersin K, Bossuyt PM. Reporting weaknesses in conference abstracts of diagnostic accuracy studies in ophthalmology. JAMA Ophthalmol. 2015;8:1–5. doi:10.1001/jamaophthalmol.2015.3577.
Campbell EG, Louis KS, Blumenthal D. Looking a gift horse in the mouth: corporate gifts support life sciences research. JAMA. 1998;279:995–9.
Rochon PA, Sekeres M, Hoey J, Lexchin J, Ferris LE, Moher D, et al. Investigator experiences with financial conflicts of interest in clinical trials. Trials. 2011;12:9. doi:10.1186/1745-6215-12-9.
Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ. 2011;343:d5621. doi:10.1136/bmj.d5621.
Johnston J. “Conflict of Interest in Biomedical Research,”. In: Crowley M, editor. From Birth to Death and Bench to Clinic: The Hastings Center Bioethics Briefing Book for Journalists, Policymakers, and Campaigns. Garrison, NY: The Hastings Center; 2008. p. 31–4.
Kjaergard LL, Als-Nielsen B. Association between competing interest and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ. 2002;325(7358):249.
Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of conflict-of-interest disclosures reported by physicians. New Eng J Med. 2009;361(15):1466–74.
Sismondo S. Ghosts in the machine: publication planning in the medical sciences. Soc Stud Sco. 2009;39(2):171–98.
Roseman M, Millette K, Bero LA, Coyne JC, Lexchin J, Turner EH, et al. Reporting of conflicts of interest in meta-analyses of trials of pharmacological treatments. JAMA. 2011;305:1008–17.
Moynihan R. Key opinion leaders: independent experts or drug representatives in disguise? BMJ. 2008;336(7658):1402–3.
