Clinical trial registration was not an indicator for low risk of bias

Journal of Clinical Epidemiology

Volumn 84, Issue , 2017, Pages 47-53

  Farquhar, Cynthia M ^a   Showell, Marian G ^a   Showell, Emily A E ^a   Beetham, Penny ^a   Baak, Nora ^b   Mourad, Selma ^c   Jordan, Vanessa M B ^a  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b UNIVERSITY OF GRONINGEN   (Netherlands)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Clinical trial registration; Evidence; Meta analysis; Quality; Risk of bias; Systematic review

Indexed keywords

ALLOCATION CONCEALMENT; ANALYTICAL PARAMETERS; ARTICLE; BELGIUM; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; DATA EXTRACTION; DENMARK; HUMAN; INDIA; INFERTILITY THERAPY; INFORMATION PROCESSING BIAS; META ANALYSIS (TOPIC); PREVALENCE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUBLICATION; QUALITY CONTROL; RANDOM SEQUENCE GENERATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTRATION; RISK ASSESSMENT; SAMPLE SIZE; SELECTIVE REPORTING; STUDY DESIGN; SYSTEMATIC REVIEW (TOPIC); TURKEY (REPUBLIC); UNITED KINGDOM; EPIDEMIOLOGY; FEMALE; INFERTILITY; MALE; REGISTER; RISK; STATISTICAL BIAS; STATISTICS AND NUMERICAL DATA;

BIAS (EPIDEMIOLOGY); EPIDEMIOLOGIC RESEARCH DESIGN; FEMALE; HUMANS; INFERTILITY; MALE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RISK;

EID: 85012864427     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2016.11.011     Document Type: Article

References (31)

1. Moher, D., Pham, B., Jones, A., Cook, D.J., Jadad, A.R., Moher, M., et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet 352 (1998), 609–613.
2. DeAngelis, C.D., Drazen, J.M., Frizelle, F.A., Haug, C., Hoey, J., Horton, R., et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 292 (2004), 1363–1364.
3. Laine, C., Horton, R., DeAngelis, C.D., Drazen, J.M., Frizelle, F.A., Godlee, F., et al. Clinical trial registration: looking back and moving ahead. Lancet 369 (2007), 1909–1911.
4. McGee, R.G., Su, M., Kelly, P.J., Higgins, G.Y., Craig, J.C., Webster, A.C., Trial registration and declaration of registration by authors of randomized controlled trials. Transplantation 92:10 (2011), 1094–1100.
5. Riehm, K.E., Azar, M., Thombs, B.D., Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: a 5-year follow-up. J Psychosomatic Res 79:1 (2015), 1–12.
6. Scott, A., Rucklidge, J.J., Mulder, R.T., Is mandatory prospective trial registration working to prevent publication of unregistered trials and selective outcome reporting? An observational study of five psychiatry journals that mandate prospective clinical trial registration. PLoS One, 10(8), 2015, e0133718.
7. Wager, E., Williams, P., “Hardly worth the effort”? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative study. BMJ, 347, 2013, f5248.
8. Weber, W.E., Merino, J.G., Loder, E., Trial registration 10 years on. BMJ, 351, 2015, h3572.
9. Evans, T., Gulmezoglu, M., Pang, T., Registering clinical trials: an essential role for WHO. Lancet 363 (2004), 1413–1414.
10. Simes, R.J., Publication bias: the case for an international registry of clinical trials. J Clin Oncol 4 (1986), 1529–1541.
11. Zarin, D.A., Tse, T., Ide, N.C., Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 353 (2005), 2779–2787.
12. Roberts, I., Ker, K., Edwards, P., Beecher, D., Manno, D., Sydenham, E., The knowledge system underpinning healthcare is not fit for purpose and must change. BMJ, 350, 2015, h2463.
13. Tovey, D., Bero, L., Farquhar, C., Lasserson, T., MacLehose, H., MacDonald, G., A response to Ian Roberts and his colleagues. Rapid response BMJ, 350, 2015, h2463.
14. Reveiz, L., Bonfill, X., Glujovsky, D., Pinzon, C.E., Asenjo-Lobos, C., Cortes, M., et al. Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010. J Clin Epidemiol 65 (2012), 482–487.
15. Higgins, J.P., Green, S., Cochrane Handbook for Systematic Reviews of Interventions. 2011, The Cochrane Collaboration Available at www.cochrane-handbook.org Accessed October 2016.
16. Hooft, L., Korevaar, D.A., Molenaar, N., Bossuyt, P.M., Scholten, R.J., Endorsement of ICMJE's Clinical Trial Registration Policy: a survey among journal editors. The Neth J Med 72:7 (2014), 349–355.
17. Dal-Re, R., Ross, J.S., Marusic, A., Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary endpoint reporting. J Clin Epidemiol 75 (2016), 100–107.
18. Bourgeois, F.T., Murthy, S., Mandl, K.D., Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 153 (2010), 158–166.
19. Dwan, K., Altman, D.G., Cresswell, L., Blundell, M., Gamble, C.L., Williamson, P.R., Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev, 2011, MR000031.
20. Ewart, R., Lausen, H., Millian, N., Undisclosed changes in outcomes in randomized controlled trials: an observational study. Ann Fam Med 7:6 (2009), 542–546.
21. Mathieu, S., Boutron, I., Moher, D., Altman, D.G., Ravaud, P., Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 302 (2009), 977–984.
22. Reveiz, L., Cortes-Jofre, M., Asenjo Lobos, C., Nicita, G., Ciapponi, A., Garcia-Dieguez, M., et al. Influence of trial registration on reporting quality of randomized trials: study from highest ranked journals. J Clin Epidemiol 63 (2010), 1216–1222.
23. Turner, L., Shamseer, L., Altman, D.G., Weeks, L., Peters, J., Kober, T., et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev, 11, 2012, MR000030.
24. Mathieu, S., Chan, A.W., Ravaud, P., Use of trial register information during the peer review process. PLoS One, 8(4), 2013, e59910.
25. Schulz, K.F., Chalmers, I., Hayes, R.J., Altman, D.G., Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273 (1995), 408–412.
26. Walker, K.F., Stevenson, G., Thornton, J.G., Discrepancies between registration and publication of randomised controlled trials: an observational study. JRSM Open, 5(5), 2014 2042533313517688.
27. Huic, M., Marusic, M., Marusic, A., Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS One, 6(9), 2011, e25258.
28. Killeen, S., Sourallous, P., Hunter, I.A., Hartley, J.E., Grady, H.L., Registration rates, adequacy of registration, and a comparison of registered and published primary outcomes in randomized controlled trials published in surgery journals. Ann Surg 259:1 (2014), 193–196.
29. Chalmers, I., Underreporting research is scientific misconduct. JAMA 263 (1990), 1405–1408.
30. Hopewell, S., Loudon, K., Clarke, M.J., Oxman, A.D., Dickersin, K., Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev, 2009, MR000006.
31. Guyatt, G.H., Oxman, A.D., Vist, G.E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336 (2008), 924–926.