Clinical Trials

❘❙❚■ Chapter 37 | Critical Appraisal of a Report9. What are the implications of the study results and discussion?In the discussion section of the article, readers should expect to find a balancedinterpretation of the results, taking into account any previous work. A guide tothe format of a submission of a clinical trial is shown in Table 2. The biologicalplausibility of the results should be addressed, along with the impact on currentmedical practice. Although the authors will offer their interpretation of the data, thereader must draw their own conclusions about the importance and impact of theresults compared with conventional treatment strategies. A significant report maylead to changes in guidelines, but this usually requires either a very large definitivestudy or at least two large independent trials supporting the same conclusion.The conclusions of the publication might be biased or restricted in commerciallyfunded studies. Major journals have guidelines for the disclosure of industry’s rolein a clinical trial. These guidelines require the authors to disclose full details oftheir role (and the sponsors) in a study. Some journals insist that the responsibleauthor sign a statement indicating that he or she accepts full responsibility for theconduct of the trial, has had full access to the data, and has control of the decisionto publish, independent of the commercial sponsors funding the work [14].10. What were the limitations of the study?Having decided to read the full study manuscript, it is essential to appreciatethe limitations of a study. Indeed, most discussions with peers about a recenttrial report are won by the person who understands the flaws of a study, inaddition to the positive implications. The authors of a study are usually aware ofmost of their study’s limitations, but often they will only write about those that canbe defended. While these are valid tactics, the best investigators will discuss all thelimitations and recommend how future studies should be conducted to overcomethese. Some limitations are inherent to most studies – such as the phenomenonthat most participants in a trial are generally healthier as a result of exclusioncriteria – and so the ability of study results to be generalized should also bediscussed. A balanced discussion suggests the mark of careful and considerateclinical scientists and researchers, and lends the overall report more credibility.ConclusionInevitably, there is far more information being published then can be read andcommitted to memory. It is therefore natural to restrict our focus to titles relevantto our own work. For these titles, we scan the abstract and decide whether to read436