Erratum: Subgroup analyses in randomised controlled trials: Cohort study on trial protocols and journal publications (BMJ (Online) (2014) 349 (g4539) DOI: 10.1136/bmj.g4539);Subgroup analyses in randomised controlled trials: Cohort study on trial protocols and journal publications

BMJ (Online)

Volumn 349, Issue , 2014, Pages

  Kasenda, Benjamin ^a   Schandelmaier, Stefan ^a   Sun, Xin ^a   Von Elm, Erik ^a   You, John ^a   Blümle, Anette ^a   Tomonaga, Yuki ^a   Saccilotto, Ramon ^a   Amstutz, Alain ^a   Bengough, Theresa ^a   Meerpohl, Joerg J ^a   Stegert, Mihaela ^a   Olu, Kelechi K ^a   Tikkinen, Kari A O ^a   Neumann, Ignacio ^a   Carrasco Labra, Alonso ^a   Faulhaber, Markus ^a   Mulla, Sohail M ^a   Mertz, Dominik ^a   Akl, Elie A ^a   Bassler, Dirk ^a   Busse, Jason W ^a   Ferreira González, Ignacio ^a   Lamontagne, Francois ^a   Nordmann, Alain ^a   Gloy, Viktoria ^a   Raatz, Heike ^a   Moja, Lorenzo ^a   Rosenthal, Rachel ^a   Ebrahim, Shanil ^a   Vandvik, Per O ^a   Johnston, Bradley C ^a   Walter, Martin A ^a   Burnand, Bernard ^a   Schwenkglenks, Matthias ^a   Hemkens, Lars G ^a   Bucher, Heiner C ^a   Guyatt, Gordon H ^a   Briel, Matthias ^a   more..

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANADA; CLINICAL PROTOCOL; COHORT ANALYSIS; DOCUMENTATION; GERMANY; HEALTH CARE ORGANIZATION; HUMAN; PATIENT PARTICIPATION; PEER REVIEW; PRIORITY JOURNAL; PUBLICATION; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RETROSPECTIVE STUDY; SCIENTIFIC LITERATURE; SWITZERLAND; INFORMATION PROCESSING; METHODOLOGY; STATISTICS;

CANADA; CLINICAL PROTOCOLS; COHORT STUDIES; DATA COLLECTION; GERMANY; HUMANS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SWITZERLAND;

EID: 84904320451     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g4921     Document Type: Erratum

References (28)

1. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review. BMJ 2011;342:d1569.
2. Hernandez AV, Boersma E, Murray GD, Habbema JD, Steyerberg EW. Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading? Am Heart J 2006;151:257-64. (Pubitemid 43148981)
3. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine - reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357:2189-94.
4. Gabler NB, Duan N, Liao D, Elmore JG, Ganiats TG, Kravitz RL. Dealing with heterogeneity of treatment effects: is the literature up to the challenge? Trials 2009;10:43.
5. Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000;355:1064-9. (Pubitemid 30162810)
6. Szczech LA, Berlin JA, Feldman HI. The effect of antilymphocyte induction therapy on renal allograft survival. A meta-analysis of individual patient-level data. Anti-Lymphocyte Antibody Induction Therapy Study Group. Ann Intern Med 1998;128:817-26. (Pubitemid 28267714)
7. Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, et al. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet 2003;361:107-16. (Pubitemid 36092014)
8. Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann Intern Med 1992;116:78-84.
9. Sun X, Ioannidis JP, Agoritsas T, Alba AC, Guyatt G. How to use a subgroup analysis: users' guide to the medical literature. JAMA 2014;311:405-11.
10. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med 2002;21:2917-30.
11. Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005;365:176-86. (Pubitemid 40091809)
12. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93-8.
13. Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ 2010;340:c117.
14. 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. (Pubitemid 351978096)
15. Chan AW. Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med 2008;5:e230.
16. Chan AW, Hrobjartsson A, Jorgensen KJ, Gotzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008;337:a2299.
17. Kasenda B, von Elm EB, You J, Blumle A, Tomonaga Y, Saccilotto R, et al. Learning from Failure - Rationale and Design for a Study about Discontinuation of Randomized Trials (DISCO study). BMC Med Res Methodol 2012;12:131.
18. Kasenda B, von Elm E, You J, Blumle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA 2014;311:1045-51.
19. Sun X, Briel M, Busse JW, You JJ, Akl EA, Mejza F, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ 2012; 344: e1553.
20. Chan AW, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman DG. Research protocols: waiving confidentiality for the greater good. BMJ 2006;332:1086-9. (Pubitemid 44365493)
21. Bhandari M, Devereaux PJ, Li P, Mah D, Lim K, Schunemann HJ, et al. Misuse of baseline comparison tests and subgroup analyses in surgical trials. Clin Orthop Relat Res 2006;447:247-51. (Pubitemid 44324921)
22. Boonacker CW, Hoes AW, van Liere-Visser K, Schilder AG, Rovers MM. A comparison of subgroup analyses in grant applications and publications. Am J Epidemiol 2011;174:219-25.
23. ClinicalTrials.gov. Protocol Data Element Definitions (DRAFT). 2013. http://prsinfo.clinicaltrials.gov/definitions.html (accessed March 2014).
24. ICTRP. Search Portal. 2014. http://www.who.int/ictrp/search/en/ (accessed March 2014).
25. ISRCTN. Data Set. 2012. http://www.controlled-trials.com/isrctn/isrctn- dataset (accessed March 2014).
26. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-7.
27. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
28. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.