Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

Trials

Volumn 13, Issue , 2012, Pages

  Schiller, Petra ^a   Burchardi, Nicole ^b   Niestroj, Michael ^a   Kieser, Meinhard ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b AGO and Coordinating Center for Clinical Trials   (Germany)

Author keywords

Equivalence; Methodological quality; Non inferiority; Randomised clinical trials; Reporting quality

Indexed keywords

ARTICLE; COCHRANE LIBRARY; INTENTION TO TREAT ANALYSIS; MEDLINE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE;

BIBLIOMETRICS; EDITORIAL POLICIES; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; PERIODICALS AS TOPIC; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 84869001712     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-13-214     Document Type: Article

References (24)

1. Fleming TR. Current issues in non-inferiority trials. Stat Med 2008, 27:317-322. 10.1002/sim.2855, 17340597.
2. D'Agostinio RB. Non-inferiority trials: advances in concepts and methodology. Stat Med 2003, 22:165-167.
3. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996, 313:36-39. 10.1136/bmj.313.7048.36, 2351444, 8664772.
4. ICH Steering Committee Statistical Principles for Clinical Trials (E9) 1998, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf, ICH Steering Committee.
5. US Food and Drug Administration Guidance for Industry Non-Inferiority Clinical Trials. US Department of Health and human Services; 2010; available at, Rockville, USA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf, US Food and Drug Administration.
6. Moher D, Schulz KF, Altman DG, . The CONSORT Group The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194. 10.1016/S0140-6736(00)04337-3, 11323066, The CONSORT Group.
7. Schulz KF, Altman DG, Moher D, . CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 24:11-32. CONSORT Group.
8. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006, 185:263-267.
9. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010, 340:c723. 10.1136/bmj.c723, 2844941, 20332510.
10. Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting non-inferiority and equivalence randomised trials. JAMA 2006, 295:1147-1151. 10.1001/jama.295.10.1147, 16522835.
11. Ivers NM, Taljaard M, Dixon S, Bennett C, McRae A, Taleban J, Skea Z, Brehaut JC, Boruch RF, Eccles MP, Grimshaw JM, Weijer C, Zwarenstein M, Donner A. Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8. BMJ 2011, 343:d5886. 10.1136/bmj.d5886, 3180203, 21948873.
12. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, . CONSORT Group Reporting of non-inferiority and equivalence randomised trials: an extension of the CONSORT statement. JAMA 2006, 295:1152-1160. 10.1001/jama.295.10.1152, 16522836, CONSORT Group.
13. Eyawo O, Lee CW, Rachlis B, Mills EJ. Reporting of noninferiority and equivalence randomized trials for major prostaglandins: a systematic survey of the ophthalmology literature. Trials 2008, 3(9):69.
14. Wangge G, Klungel OH, Roes KC, de Boer A, Hoes AW, Knol MJ. Room for improvement in conducting and reporting non-inferiority randomized controlled trials on drugs: a systematic review. PLoS One 2010, 5(10):e13550. 10.1371/journal.pone.0013550, 2965079, 21048948.
15. European Medicine Agency Guideline on the choice of the non-inferiority margin Committee for Medicinal Products for Human Use; 2005; available at, London, UK, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf, European Medicine Agency.
16. 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,
17. Fleiss JL. Measuring nominal scale agreement among many raters. Psychol Bull 1971, 76:378-382.
18. Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'. Trials 2008, 18:20.
19. Partsinevelou A, Zintzaras E. Quality of reporting of randomized controlled trials in polycystic ovary syndrome. Trials 2009, 20:106.
20. Balasubramanian SP, Wiener M, Alshameeri Z, Tiruvoipati R, Elbourne D, Reed MW. Standards of reporting of randomized controlled trials in general surgery: can we do better?. Ann Surg 2006, 244:663-667. 10.1097/01.sla.0000217640.11224.05, 1856614, 17060756.
21. Wang JL, Sun TT, Lin YW, Lu R, Fang JY. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study. BMC Med Res Methodol 2011, 11:110. 10.1186/1471-2288-11-110, 3161027, 21801429.
22. Parsons N, Hiskens R, Price CL, Costa ML. A systematic survey of the quality of research reporting in general orthopaedic journals. J Bone Joint Surg Br 2011, 93:1154-1159. 10.1302/0301-620X.93B9.27193, 21911523.
23. Hirst A, Altman DG. Are peer reviewers encouraged to use reporting guidelines? A survey of 116 health research journals. PLoS One 2012, 7:e35621. 10.1371/journal.pone.0035621, 3338712, 22558178.
24. Simera I, Moher D, Hirst A, Hoey J, Schulz KF, Altman DG. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Medicine 2010, 8:24. 10.1186/1741-7015-8-24, 2874506, 20420659.