CONSORT statements/recommendation

The CONSORT statement (Moher et al. (2001)) sets down standards for the reporting of clinical trials and their recommendations in relation to the sample size calculation are in line with these points. 

In recent years there have been a range of recommendations regarding the structure of publications how they should be laid out and what they should contain. These have usually been in the form of checklists and all of this has been encapsulated within the CONSORT statement (Moher et al. (2001) and Altman et al. (2001)). CONSORT is an acronym for Consolidated Standards of Reporting Trials and increasingly many medical journals have adopted this guidance in terms of requiring their clinical trial publications to conform to it. There is a web site which provides up-to-date information and helpful resources and examples WWW. consort- statement.org. 

MUler DH, Khan OA, Sheremata WA, Blumhardt LD et al., for the International Natalizumab Multiple Sclerosis Trial Group (2003) A controUed trial of natalizumab for relapsing multiple sclerosis New England Journal of Medicine, 348, 15-23 Moher D, Schulz KF and Altman DG (2001) The CONSORT statement Revised recommendations for improving the quahty of reports of paraUel-group randomized trials Annals of Internal Medicine, 134, 657-694... 

Moher, D., Schulz, K.F., Altman, D., for the CONSORT Group, 2001, The CONSORT Statement Revised recommendations for improving the quality of reports of parallel-group randomized trials, Journal of the American Medical Association, 285 1987-1991. 

Moher D, Schulz KF, Altman DG for the CONSORT group. The CONSORT statement revised recommendations for improving the quality of reports... 

Guidelines for reporting clinical trials in clinical communications are provided by the Consolidated Standards of Reporting Trials (CONSORT) group. We recommend that you read the CONSORT statements (see www. consort-statement, org). We also refer you to Bowers et al. (2006) and Stuart (2007) for extensive coverage of this topic. 

Authors associated with the CONSORT statement on clinical trials (Altman et al, 2001) have recently made ten recommendations as regards the reporting of what they refer to as harms (loannidis et cd., 2004). Indeed, part of the purpose of their recommendations is to promote the use of the term hann, or harms, since they believe that talk of drug safety gives an unrealistic impression of the inevitable risks associated with pharmaceutical therapy. As they put it, We encourage authors to use the term harms instead of safety (p. 781). The definition they offer for this term is... 

Table 15.3 Recommendations of the CONSORT extension statement on harms...

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