CONSORT statement

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. 

Most of the elements are contained within the sample size section according to the requirements set down in the CONSORT statement the only omissions seem to be specification of the statistical test on which the sample size calculation was based, the assumed standard deviation of the primary endpoint and the basis of that assumption. 

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. 

Altman DG, Schultz KF, Moher D, Egger M et al. for the CONSORT Group (2001) The revised CONSORT statement for reporting randomized trials explanation and elaboration Annals of Internal Medicine, 134, 663-694... 

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... 

There is also a CONSORT statement concerning the reporting of cluster randomized trials (recall Section 5.6.2). The added complexities of these studies mean that reporting guidance specifically for these trials is appropriate (see Campbell et al., 2004). Additionally, the CONSORT group has published a statement on reporting equivalence and noninferiority randomized trials (see Piaggio et al., 2006). 

Campbell, M.K., Elboume, D.R., Altman, D.G., for the CONSORT Group, 2004, CONSORT statement Extension to cluster randomised trials, British Medical Journal, 328 702-708. 

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. 

It may be possible to undertake a meta-analysis if data are available from a number of similar studies (i.e., asking the same question in the same type of patients and in the same or similar clinical settings). Meta-analyses can explore sources of variability in the results of clinical studies, increase confidence in the data and conclusions, and signal when no further studies are necessary. For guidelines on conduct of meta-analyses of RCTs, see the Quality of Reporting of Meta-analyses (QUORUM) statement at http //www.consort-statement.org/QUOROM.pdf (accessed April 22, 2004). 

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. 

Altman DG (1996) Better reporting of randomised controlled trials the CONSORT statement [editorial] [see comments]. British Medical Journal 313 570-571. 

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... 

CONSORT. Consolidated Statement of Reporting Trials. Guidelines with the object of improving clinical trial reporting in the journals. See http //www.consort-statement.org/. They are extremely useful as far as they go but far less ambitious in scope or detailed than the ICH guidelines. 

Harms. A term which is being promoted by the authors of the CONSORT statement to describe any undesirable consequences of treatment. 

Altman DF, Schulz KF, Moher D (2001) Turning a blind eye testing the success of blinding and the CONSORT statement. BMJ 328 1135... 

Begg C, Cho M, Eastwood S et al (1996) Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276 637-639... 

Consort Group (2016) Consort statement transparent reporting of trials. Available at http //www. consort-statement.org. Accessed 1 Jan 2016... 

---