Explanation & Elaboration document (E&E)
One feature of the original CONSORT Statement in 1996 (1), shared by its two precursors (2,3), was the near absence of any explanation of the concepts or justification for the importance of specific information being needed in reports of randomized trials. It was recommended that the value of the CONSORT Statement, and probably also its acceptability, could be enhanced by the development of a second publication that clarified the scientific background and explained why each issue was important (4).
Therefore when the CONSORT Statement was revised in 1999, the opportunity was taken to develop, in parallel to the revised checklist, a detailed explanatory document. The resulting 32-page Expanation and Elaboration (E&E) document was published simultaneously with the revised CONSORT Statement in the Annals of Internal Medicine in 2001 (5,6). It was recognized as an important innovation and the idea has subsequently been taken up by other reporting guideline groups (7).
The E&E document addresses each checklist item individually. For each item, key methodological issues are explained and a summary of the empirical evidence about the importance of reporting that item is provided. Examples of clear reporting are also given for each checklist item.
It is recommended that the CONSORT Statement checklist is read in conjunction with the accompanying E&E document. As such, whenever the CONSORT checklist is updated, the accompanying E&E document will also be updated.
References
1. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-9. [PMID: 0008773637]
2. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994;272:1926-31. [PMID: 0007990245]
3. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1994;121:894-5. [PMID: 0007978706]
4. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996;313:570-1. [PMID: 0008806240]
5. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. Ann Intern Med. 2001;134:657-62. [PMID: 11304106]
6. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche P, Lang T for the CONSORT Group. The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration. Ann Intern Med 2001;134(8):663-94. [PMID: 11304107]
7. Plint AC, Moher D, Schulz K, Altman DG,
Morrison A. Does the CONSORT checklist improve the quality of reports of
randomized controlled trials? A systematic review. Firth International Congress
of Peer Review and Biomedical Publication, September 16-18 2005. [PMID:
16948622]
Page last edited: 02 April 2008
