Evidence of selective reporting bias in hematology journals: A systematic review

PLoS ONE

Volumn 12, Issue 6, 2017, Pages

  Wayant, Cole ^a   Scheckel, Caleb ^b   Hicks, Chandler ^a   Nissen, Timothy ^a   Leduc, Linda ^c   Som, Mousumi ^c   Vassar, Matt ^a  

^a OKLAHOMA STATE UNIVERSITY CENTER FOR HEALTH SCIENCES   (United States)

^b MAYO CLINIC   (United States)

^c OKLAHOMA STATE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; CYCLOPHOSPHAMIDE; DOXORUBICIN; PREDNISONE; RITUXIMAB; VINCRISTINE;

ARTICLE; CANCER SURVIVAL; CITATION ANALYSIS; CONTROLLED STUDY; DIFFUSE LARGE B CELL LYMPHOMA; HEMATOLOGIC MALIGNANCY; HEMATOLOGY; HUMAN; INFORMATION PROCESSING BIAS; MEDICAL DECISION MAKING; MEDICAL LITERATURE; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PROGRESSION FREE SURVIVAL; PUBLICATION; SELECTIVE REPORTING BIAS; STANDARDIZATION; SYSTEMATIC REVIEW; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC);

HEMATOLOGY; HUMANS; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85019998458     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0178379     Document Type: Article

References (56)

1. Dwan K, Altman DG, Clarke M, Gamble C, Higgins JPT, Sterne JAC, et al. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med. 2014; 11(6):e1001666. https://doi.org/10.1371/journal.pmed.1001666 PMID: 24959719
2. De Oliveira GS Jr., Jung MJ, McCarthy RJ. Discrepancies Between Randomized Controlled Trial Registry Entries and Content of Corresponding Manuscripts Reported in Anesthesiology Journals. Anesth Analg. 2015; 121(4):1030-3. https://doi.org/10.1213/ANE.0000000000000824 PMID: 26378702
3. Rasmussen N, Lee K, Bero L. Association of trial registration with the results and conclusions of published trials of new oncology drugs. Trials. 2009; 10:116. https://doi.org/10.1186/1745-6215-10-116 PMID: 20015404
4. Raghav KPS, Mahajan S, Yao JC, Hobbs BP, Berry DA, Pentz RD, et al. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology. J Clin Oncol. 2015; 33(31):3583-90. https://doi.org/10.1200/JCO.2015.62.4148 PMID: 26304898
5. Jones CW, Keil LG, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med. 2015; 13:282. https://doi.org/10.1186/s12916-015-0520-3 PMID: 26581191
6. Pinto RZ, Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG, et al. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials. Phys Ther. 2013; 93(3):299-309. https://doi.org/10.2522/ptj.20120206 PMID: 23125281
7. Besselink MGH, Gooszen HG, Buskens E. Clinical trial registration and the ICMJE. JAMA. 2005; 293 (2):157-8; author reply 8. https://doi.org/10.1001/jama.293.2.157-c PMID: 15644531
8. Khalil O, Govindarajan R, Safar M, Hutchins L, Mehta P. Clinical trial registration and the ICMJE. JAMA. 2005; 293(2):157; author reply 8. https://doi.org/10.1001/jama.293.2.157-b PMID: 15644532
9. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004; 292(11):1363-4. https://doi.org/10.1001/jama.292.11.1363 PMID: 15355936
10. Laine C, Horton R, De Angelis C, Drazen JM, Frizelle FA, Godlee F, et al. Clinical trial registration: looking back and moving ahead. Med J Aust. 2007; 186(12):612-3. PMID: 17576172
11. Trends, Charts, and Maps. [Internet]. Revised May 2017. Accessed May 3, 2017. https://clinicaltrials.gov/ct2/resources/trends.
12. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Ann Intern Med. 2005; 143(2):146-8. PMID: 16027458
13. 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;(1):MR000031. https://doi.org/10.1002/14651858.MR000031.pub2 PMID: 21249714
14. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010; 340:c365. https://doi.org/10.1136/bmj.c365 PMID: 20156912
15. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009; 302(9):977-84. https://doi.org/10.1001/jama. 2009.1242 PMID: 19724045
16. Goldacre B, Drysdale H, Powell-Smith A, Dale A, Milosevic I, Slade E, Hartley P, Marston C, Mahtani K, Heneghan C. The COMPare Trials Project. www.COMPare-trials.org, 2016.
17. Code of Federal Regulations, Department of Health and Human Services: Title 45 Public Welfare, Part 46 Protection of Human Subjects. [Internet]. Revised January 15, 2009. Effective July 14, 2009. Accessed July 1, 2016.
18. Li T, Vedula SS, Hadar N, Parkin C, Lau J, Dickersin K. Innovations in data collection, management, and archiving for systematic reviews. Ann Intern Med. 2015; 162(4):287-94. https://doi.org/10.7326/M14-1603 PMID: 25686168
19. Cochrane Handbook for Systematic Reviews of Interventions. [Internet]. Published November 19, 2014. Accessed November 19, 2014. http://handbook.cochrane.org/.
20. Standards for Systematic Reviews: Health and Medicine Division. [Internet]. Published June 21, 2016. Accessed June 21, 2016. http://www.nationalacademies.org/hmd/Reports/2011/Finding-What-Worksin-Health-Care-Standards-for-Systematic-Reviews/Standards.aspx.
21. The PRISMA Statement Checklist. [Internet]. Published June 22, 2016. Accessed June 22, 2016. http://www.prisma-statement.org/documents/PRISMA2009checklist.pdf.
22. SAMPL Guidelines. [Internet]. Published June 21, 2016. Accessed June 21, 2016. http://www.equatornetwork.org/wp-content/uploads/2013/07/SAMPL-Guidelines-6-27-13.pdf.
23. An NIH Outreach Toolkit: NIH Definitions. http://orwh.od.nih.gov/toolkit/nih-policies-inclusion/definitions.html. Published June 22, 2016. Accessed June 22, 2016.
24. SRDR-Systematic Review Data Repository | Home. http://srdr.ahrq.gov/. Published June 20, 2016. Accessed June 20, 2016.
25. Glanville JM, Duffy S, McCool R, Varley D. Searching Clinical Trials.gov and the International Clinical Trials Registry Platform to inform systematic reviews: what are the optimal search approaches? J Med Libr Assoc. 2014; 102(3):177-83. https://doi.org/10.3163/1536-5050.102.3.007 PMID: 25031558
26. WHO International Clinical Trials Registry Platform (ICTRP). [Internet]. Published June 22, 2016. Accessed June 22, 2016.
27. Chan A-W, 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(20):2457-65. https://doi.org/10.1001/jama.291.20.2457 PMID: 15161896
28. Smyth RMD, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ. 2011; 342:c7153. https://doi.org/10.1136/bmj.c7153 PMID: 21212122
29. Pocock SJ, Stone GW. The Primary Outcome Fails-What Next? N Engl J Med. 2016; 375(9):861-70. https://doi.org/10.1056/NEJMra1510064 PMID: 27579636
30. Chan A-W, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005; 330(7494):753. https://doi.org/10.1136/bmj.38356. 424606.8F PMID: 15681569
31. Dillman DA, Smyth JD, Christian LM. Internet, Phone, Mail and Mixed-Mode Surveys: The Tailored Design Method, 4th edn. Hoboken, NJ: John Wiley, 2014.
32. Seymour JF, Pfreundschuh M, Trneæný M, Sehn LH, Catalano J, Csinady E, et al. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014; 99(8):1343-9. https://doi.org/10.3324/haematol.2013.100818 PMID: 24895339
33. You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol. 2012; 30(2):210-6. https://doi.org/10.1200/JCO.2011.37.0890 PMID: 22162583
34. Li X-Q, Yang G-L, Tao K-M, Zhang H-Q, Zhou Q-H, Ling C-Q. Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology. Scand J Gastroenterol. 2013; 48(12):1474-83. https://doi.org/10.3109/00365521.2013.845909 PMID: 24131272
35. Killeen S, Sourallous P, Hunter IA, Hartley JE, Grady HLO. Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery Journals. Ann Surg. 2014; 259(1):193-6. https://doi.org/10.1097/SLA. 0b013e318299d00b PMID: 23732270
36. Rongen JJ, Hannink G. Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials of Orthopaedic Surgical Interventions. J Bone Joint Surg Am. 2016; 98(5):403-9. https://doi.org/10.2106/JBJS.15.00400 PMID: 26935463
37. Hannink G, Gooszen HG, Rovers MM. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg. 2013; 257(5):818-23. https://doi.org/10.1097/SLA.0b013e3182864fa3 PMID: 23407296
38. Dal-Ré R, Caplan AL. Journal editors impasse with outcome reporting bias. Eur J Clin Invest. 2015; 45 (9):895-8. https://doi.org/10.1111/eci.12484 PMID: 26108701
39. FDAAA for NIH Grantees: The Basics. https://grants.nih.gov/clinicaltrials-fdaaa/the-basics.htm#whatisFDAAA. [Internet]. Updated September 16, 2016. Accessed May 3, 2017.
40. Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open. 2015; 5(9):e008932. https://doi.org/10.1136/bmjopen-2015-008932 PMID: 26408831
41. Talbott JA. Salami Slicing, Duplicative Publication, and Data Set Utilization: Where to Draw the Line. J Nerv Ment Dis. 2016; 204(11):868. https://doi.org/10.1097/NMD.0000000000000630 PMID: 27798542
42. Cheung VWF, Lam GOA, Wang YF, Chadha NK. Current incidence of duplicate publication in otolaryngology. Laryngoscope. 2014; 124(3):655-8. https://doi.org/10.1002/lary.24294 PMID: 23818310
43. Durani P. Duplicate publications: redundancy in plastic surgery literature. J Plast Reconstr Aesthet Surg. 2006; 59(9):975-7. https://doi.org/10.1016/j.bjps.2005.11.039 PMID: 16920591
44. Schein M, Paladugu R. Redundant surgical publications: tip of the iceberg? Surgery. 2001; 129(6):655-61. https://doi.org/10.1067/msy.2001.114549 PMID: 11391360
45. Spielmans GI, Biehn TL, Sawrey DL. A case study of salami slicing: pooled analyses of duloxetine for depression. Psychother Psychosom. 2010; 79(2):97-106. https://doi.org/10.1159/000270917 PMID: 20051707
46. Tugwell P, Knottnerus JA. Are triallists guilty of 'imbalanced salami slicing'- by favouring positive results in secondary publications? J Clin Epidemiol. 2016; 79:1-2. https://doi.org/10.1016/j.jclinepi.2016.11. 005 PMID: 27931693
47. Klein AA, Pozniak A, Pandit JJ. Salami slicing or living off the fat? Justifying multiple publications from a single HIV dataset. Anaesthesia. 2014; 69(3):195-8. https://doi.org/10.1111/anae.12603 PMID: 24548349
48. Beaufils P, Karlsson J. Legitimate division of large datasets, salami slicing and dual publication. Where does a fraud begin? Orthop Traumatol Surg Res. 2013; 99(2):121-2. https://doi.org/10.1016/j.otsr. 2013.01.001 PMID: 23434431
49. Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on Trial Registration 11 Years after the ICMJE Policy Was Established. N Engl J Med. 2017; 376(4):383-91. https://doi.org/10.1056/NEJMsr1601330 PMID: 28121511
50. Barraclough H, Govindan R. Biostatistics primer: what a clinician ought to know: subgroup analyses. J Thorac Oncol. 2010; 5(5):741-6. https://doi.org/10.1097/JTO.0b013e3181d9009e PMID: 20421767
51. Guillemin F. Primer: the fallacy of subgroup analysis. Nat Clin Pract Rheumatol. 2007; 3(7):407-13. https://doi.org/10.1038/ncprheum0528 PMID: 17599075
52. Kasenda B, Schandelmaier S, Sun X, von Elm E, You J, Blümle A, et al. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications. BMJ. 2014; 349:g4539. https://doi.org/10.1136/bmj.g4539 PMID: 25030633
53. Venekamp RP, Rovers MM, Hoes AW, Knol MJ. Subgroup analysis in randomized controlled trials appeared to be dependent on whether relative or absolute effect measures were used. J Clin Epidemiol. 2014; 67(4):410-5. https://doi.org/10.1016/j.jclinepi.2013.11.003 PMID: 24508145
54. Zhang S, Liang F, Li W, Hu X. Subgroup Analyses in Reporting of Phase III Clinical Trials in Solid Tumors. J Clin Oncol. 2015; 33(15):1697-702. https://doi.org/10.1200/JCO.2014.59.8862 PMID: 25897150
55. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013; 158(3):200-7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583 PMID: 23295957
56. Baron F, Suciu S, Amadori S, Muus P, Zwierzina H, Denzlinger C, et al. Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group. Haematologica. 2012; 97(4):529-33. https://doi.org/10.3324/haematol.2011.044347 PMID: 22102701