CONSORT 2010 Sttement lacademia and clinic n2001 Any support to and ou to this CONSOR CONSORT GROUP ( Elaboration,and the CONSORT Web site in their "We suggest that authors who wish ld cit ORr200teroftheos SORT Gro up(C dated St tatement an Fl(13) the CONSORT 2010 AIl CONSORT an DG,Hill C,et al Doe CON metinioobherlhrgaC PCONSORT 2010 evolving guideline.It reauires raisal and.if 1.C fIn the future we wll further reise pbell MK.Eb materia me DR.Alm DG.)Eans ]CONSORT via he PC. RB.20103 MA1995273 oher M,et al Doe Grant Support:From United Kingdom National Institute for Health and the Me al R nd Am m1mM2091512649.6.mD:19625i PP. y a Uni DC.r M5)Getnde PC.Vandenb rengthening the Reporting of Obs Potential Conflicts of Interest:Disclos 79383961 o//.domNum-M10-0379 5950 search I rangle Park,NC 27709 -3.[PMI 2178DG.Em References 8R429125765 3.Glasriou P.Meats E.He 056 D:1 at is iNK.Bams KE Egger CH,Brid M www.amnals.orgCONSORT 2010 supplants the prior version pub￾lished in 2001. Any support for the earlier version accu￾mulated from journals or editorial groups will automati￾cally extend to this newer version, unless specifically requested otherwise. Journals that do not currently support CONSORT may do so by registering on the CONSORT Web site. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of CONSORT 2010, the CONSORT 2010 Explanation and Elaboration, and the CONSORT Web site in their “in￾structions to authors.” We suggest that authors who wish to cite CONSORT should cite this or another of the orig￾inal journal versions of CONSORT 2010 Statement and, if appropriate, the CONSORT 2010 Explanation and Elaboration (13). All CONSORT material can be accessed through the original publishing journals or the CONSORT Web site. Groups or individuals who desire to translate the CONSORT 2010 Statement into other languages should first consult the CONSORT policy statement on the Web site. We emphasize that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, modifications. In the future, we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite read￾ers to submit recommendations via the CONSORT Web site. From Family Health International, Research Triangle Park, North Caro￾lina; Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom; and Ottawa Methods Centre, Clin￾ical Epidemiology Program, Ottawa Hospital Research Institute, Univer￾sity of Ottawa, Ottawa, Ontario, Canada. Grant Support: From United Kingdom National Institute for Health Research and the Medical Research Council; Canadian Institutes of Health Research; Presidents Fund, Canadian Institutes of Health Re￾search; Johnson & Johnson; BMJ; and American Society for Clinical Oncology. Dr. Altman is supported by Cancer Research UK, Dr. Moher by a University of Ottawa Research Chair, and Dr. Schulz by Family Health International. None of the sponsors had any involvement in the planning, execution, or writing of the CONSORT documents. In addi￾tion, no funder played a role in drafting the manuscript. Potential Conflicts of Interest: Disclosures can be viewed at www.acponline .org/authors/icmje/ConflictOfInterestForms.do?msNum
M10-0379. Corresponding Author: Kenneth F. Schulz, PhD, MBA, Family Health International, PO Box 13950, Research Triangle Park, NC 27709. Current author addresses and author contributions are available at www .annals.org. References 1. Ju¨ni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-6. [PMID: 11440947] 2. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365:1159-62. [PMID: 15794971] 3. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from de￾scriptions of treatment in trials and reviews? BMJ. 2008;336:1472-4. [PMID: 18583680] 4. 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 out￾come reporting bias. PLoS One. 2008;3:e3081. [PMID: 18769481] 5. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT state￾ment. JAMA. 1996;276:637-9. [PMID: 8773637] 6. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised rec￾ommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191-4. [PMID: 11323066] 7. Moher D, Schulz KF, Altman DG; CONSORT GROUP (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommen￾dations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-62. [PMID: 11304106] 8. Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Stan￾dards of Reporting Trials). The CONSORT statement: revised recommenda￾tions for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-91. [PMID: 11308435] 9. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised con￾trolled trials? A systematic review. Med J Aust. 2006;185:263-7. [PMID: 16948622] 10. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: a comparative study of articles indexed by PubMed. BMJ. 2010;340:c723. 11. Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004;328:702-8. [PMID: 15031246] 12. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an exten￾sion of the CONSORT statement. JAMA. 2006;295:1152-60. [PMID: 16522836] 13. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. 14. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment ef￾fects in controlled trials. JAMA. 1995;273:408-12. [PMID: 7823387] 15. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352:609-13. [PMID: 9746022] 16. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009;151:264-9, W64. [PMID: 19622511] 17. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative. Ann Intern Med. 2003;138:40-4. [PMID: 12513043] 18. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbro￾ucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observa￾tional studies. Ann Intern Med. 2007;147:573-7. [PMID: 17938396] 19. The Standards of Reporting Trials Group. A proposal for structured report￾ing of randomized controlled trials. JAMA. 1994;272:1926-31. [PMID: 7990245] 20. Rennie D. Reporting randomized controlled trials. An experiment and a call for responses from readers [Editorial]. JAMA. 1995;273:1054-5. [PMID: 7897791] 21. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al; CONSORT Group. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet. 2008;371:281-3. [PMID: 18221781] 22. Chan AW, Hro´bjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Em￾pirical evidence for selective reporting of outcomes in randomized trials: compar￾ison of protocols to published articles. JAMA. 2004;291:2457-65. [PMID: 15161896] 23. Sackett DL. Commentary: Measuring the success of blinding in RCTs: don’t, must, can’t or needn’t? Int J Epidemiol. 2007;36:664-5. [PMID: 17675306] 24. Schulz KF, Grimes DA. Blinding in randomised trials: hiding who got what. Lancet. 2002;359:696-700. [PMID: 11879884] 25. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 731