![]() A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement.Īfter an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. The statement facilitates critical appraisal and interpretation of RCTs.ĭuring the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. It was first published in 1996 and updated in 2001. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias.Ī group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Correspondence to: D Moher dmoherohri.ca.8Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland.7Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London. ![]() 6McMaster University Health Sciences Centre, Hamilton, Canada.5The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.4UK Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA.3Family Health International, Research Triangle Park, NC 27709, USA.2Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford.1Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada, K1H 8L6.Matthias Egger, head of department and professor of epidemiology and public health 8,.Diana Elbourne, professor of health care evaluation 7,.Victor Montori, professor of medicine 4,.Kenneth F Schulz, distinguished scientist and vice president 3,.Sally Hopewell, senior research fellow 2,.
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