Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘investigation at each center may either be at the end of the paper or available onthe journal or trial website.The format follows the key questions:• Why did you perform the trial? (Introduction)• How did you conduct the trial? (Methods)• What did you find? (Results)• What does it mean? (Discussion)In its introduction a trial report should give sufficient background knowledge forthe reader to understand the study aim and the hypothesis of interest; it mightinclude an overview of relevant literature and how the proposed study willimprove the situation.The methods section of a trial report should contain sufficient information on thestudy design, data collection, and statistical analysis to allow critical interpretationof the results. An important criterion of a good quality report is that its methodsshould be laid out in such a way that the intended reader is able to criticallyappraise the value of the results.The results section should contain baseline tables to describe the features of thestudy population at entry to the study, further information on completeness offollow-up, and results with respect to treatment efficacy and side-effects. Thediscussion should aim to put the findings into the context of current research,and highlight potential questions for further research. Any intended reader withsufficient background knowledge should be able to infer the conclusions on thebasis of the results presented.In other words, the methods and results should be presented in such a way thata reader is enabled to critically draw conclusions; for nonspecialist readers thereis a danger of accepting the results of studies without sufficient criticism on thepotential limitations of the study findings. For this reason, in the setting of clinicaltrials, the CONSORT (Consolidated Standards of Reporting Trials) statementhas been elaborated, and has been adopted by many leading clinical journals asa common standard for reporting.The abstract and the conclusions section of a trial report can be seen as theinterface between two groups of people: the trialist, with his/her specialistknowledge of the clinical area and the mechanics, processes, and results of thetrial itself; and the audience, which might comprise specialist medical readers orthe general lay public. As such, these sections must carefully guard against367