Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: Comparison of registered records and subsequent publications

Trials

Volumn 16, Issue 1, 2015, Pages

  Su, Chun Xiang ^a   Han, Mei ^a   Ren, Jun ^a   Li, Wen Yuan ^a   Yue, Shu Jin ^a   Hao, Yu Fang ^a   Liu, Jian Ping ^a  

^a BEIJING UNIVERSITY OF CHINESE MEDICINE   (China)

Author keywords

Acupuncture; Outcome reporting bias; Publication bias; Randomized clinical trials; Selective outcome reporting; Trial registration

Indexed keywords

ACUPUNCTURE; ARTICLE; COMPARATIVE STUDY; DATA BASE; ELECTROACUPUNCTURE; ELECTROSTIMULATION; EVIDENCE BASED PRACTICE; HUMAN; ICD-10; MEDICAL RECORD; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTERED RECORD; SAMPLE SIZE; STUDY DESIGN; SUBSEQUENT PUBLICATION; TREATMENT OUTCOME; WESTERN MEDICINE; PUBLISHING; REGISTER; STATISTICAL BIAS;

ACUPUNCTURE THERAPY; BIAS (EPIDEMIOLOGY); HUMANS; PUBLICATION BIAS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; TREATMENT OUTCOME;

EID: 84924227782     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-014-0545-5     Document Type: Article

References (29)

1. Hutton JL, Williamson PR. Bias in meta-analysis due to outcome variable selection within studies. Appl Stat. 2000;49:359-70.
2. Kirkham JJ, Dwan KM, Altman DA, 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.
3. Al-Marzouki S, Roberts I, Marshall T, Evans S. The effect of scientific misconduct on the results of clinical trials: a Delphi survey. Contemp Clin Trials. 2005;26:331-7.
4. Furukawa T, Watanabe N, Omori I, Montori V, Guyatt G. Association between unreported outcomes and effect size estimates in Cochrane meta-analyses. JAMA. 2007;297:468-70.
5. Pearson M, Peters J. Outcome reporting bias in evaluations of public health interventions: evidence of impact and the potential role of a study register. J Epidemiol Community Health. 2012;66:286-9.
6. Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290:516-23.
7. Abaid LN, Grimes DA, Schulz KF. Reducing publication bias through trial registration. Obstet Gynecol. 2007;109:1434-7.
8. De Angelis C, 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. N Engl J Med. 2004;351:1250-1.
9. Killeen S, Sourallous P, Hunter IA, Hartley JE, Grady HL. 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;259:193-6.
10. 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.
11. Chan AW, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ. 2008;337:a2299.
12. Von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M. Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee. SwissMed Wkly. 2008;138:197-203.
13. Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. Lancet. 2008;372:201.
14. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144.
15. Hahn S, Williamson PR, Hutton JL. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. J Eval Clin Pract. 2002;8:353-9.
16. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3:e3081.
17. Liu JP, Han M, Li XX, Mu YJ, Lewith G, Wang YY, et al. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study. BMJ Open. 2013;3:e002968.
18. National Center for Complementary and Alternative Medicine (NCCAM). Acupuncture: an introduction. [http://nccam.nih.gov/health/acupuncture/introduction.htm ]
19. Higgins Jpt, Green S, the Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. 2011 [http://www.cochrane-handbook.org ]
20. Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;330:753.
21. Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA. 2009;302:977-84.
22. Hannink G, Gooszen HG, Rovers MM. Comparison of registered and published primary outcomes in randomized clinical trials of surgical interventions. Ann Surg. 2013;257:818-23.
23. Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ. 2004;171:735-40.
24. Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010;153:158-66.
25. Wager E, Williams P, Project overcome failure to publish negative findings consortium. "Hardly worth the effort"? Medical journals' policies and their editors' and publishers' views on trial registration and publication bias: quantitative and qualitative study. BMJ. 2013;347:f5248.
26. van de Wetering FT, Scholten RJ, Haring T, Clarke M, Hooft L. Trial registration numbers are underreported in biomedical publications. PLoS One. 2012;7:e49599.
27. Smyth RM, 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.
28. 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;30:210-6.
29. Korevaar DA, Ochodo EA, Bossuyt PM, Hooft L. Publication and Reporting of Test Accuracy Studies Registered in ClinicalTrials.gov. Clin Chem. 2014;60:651-9.