Generalising the results of trials to clinical practice.

University of Sydney, NSW. J Paul Seale, PhD, FRACP, FRCP, Professor of Clinical Pharmacology; Val J Gebski, MStat, Associate Professor, and Principal Research Fellow; Anthony C Keech, FRACP, MClinEpi, Deputy Director, NHMRC Clinical Trials Centre. Reprints will not be available from the authors. Correspondence: Professor J P Seale, Department of Pharmacology, Blackburn Building, University of Sydney, Sydney, NSW 2006. [email protected] The Medical Journal of Australia ISSN: 0025729X 15 November 2004 181 10 558-560 ©The Medical Journal of Australia 2004 www. mja.com.au EBM: Trials on Trial the trial’s generalisability, or external validity. Th statement refers to generalisability under Item 21 (B written reports should discuss the various factors the generalisability of the trial’s find ngs. Julian and proposed a checklist of questions to assist with th (see Box 2). To determine the generalisability of a trial’s find an op ua R domised controlled trials should be the basis for develing clinical guidelines and for decisions about individl patient management. They should also inform public health policy. However, their capacity to fulfil these roles will depend on how closely a trial’s participants reflect the general population of patients with the disorder that has been investigated. The extent to which a trial’s findings are relevant to the broader population of patients with the disorder is referred to as e CONSORT ox 1). Wellthat influence Pocock have is assessment