[MUSIC] Welcome back. I'm Lea Drye and this is Introduction to Clinical Trials. Today's lecture is on clinical trials literature, standards, and critical reading. In Section A, we're going to cover reporting results from trials. In the era of a push for evidence-based medicine, in order to be able to use research that's been completed, we need for the research to be reported with enough detail for readers to evaluate it's worth for their situation. In this lecture, we're going to go over the motivation for reporting guidelines, and we're going to talk about the components of CONSORT, which are the consolidated standards of reporting trials. We also have several items that we've included that are not part of CONSORT, and we've marked those with a star. I'll discuss ways to make tables and figures more complete and easier to read. And then we'll finish with questions from Kurt. Kurt Miner was the founder of the Center for Clinical Trials at Johns Hopkins. And he has a list of questions that you can use to help you evaluate the report of a clinical trial. So, why do we have reporting requirements and clinical trials? Well, we know that physicians need to access literature to help guide practice decisions. And since we're going to be using literature to decide what treatments to be used, on whom, and when, we need to make that the reporting of our clinical trial results is accurate. And we have standards because, even though nobody sets out to write a bad paper, we do have papers and clinical trials that, that will have all the necessary information that people need in order to evaluate how well a trial was conducted. And there were several early proposals for reporting requirements in clinical trials. There was a article in JAMA in 1994 that was written by a group that called itself the Standards of Reporting in Trials Group. And around the same time there was an article that appeared in the Annals of Internal Medicine that was written by a group called the Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, and both of these set out a draft list of requirements, elements that they thought should be included in a report of a clinical trial. And then in 1995, an editorial appeared in JAMA that suggested that these two groups consolidate. And the consolidated effort is called the Consolidated Standards of Reporting Clinical Trials or CONSORT. The guidelines, from the Consort group, were initially published in 1996, but there have been updates in 2001 and in 2010. And the initial statements from the Consort group focused primarily on reporting parallel superiority trials. You'll remember from previous lessons that the majority of trials, traditionally, have been parallel superiority trials. So, that's what the original focus was on in the CONSORT statements. However, there have been extensions that we'll talk about in a moment. And the CONSORT guidelines are basically a 25 item checklist that has a list of components that should be reported in clinical trials. And this is really considered the gold standard guidance document on how trials should be reported in the literature. And editors have recognized the importance of requiring the elements of CONSORT in papers that are published in their journals. And there are several journals that require you now to follow the CONSORT guidelines when you're reporting results from a clinical trial. And, in fact, we recently submitted a article to BMJ, and they required us to submit a CONSORT checklist with our article. And the CONSORT guidelines have been translated into several language, and these are available on the website, and I've listed the website here. The website also has details about the items on the check-list as well as examples of well written papers. The purpose of CONSORT is to make the experimental process more clear, flawed or not, so that users of the data can more appropriately evaluate its validity for their purposes. So, this is an important point because the purpose of consort is not to tell you how to conduct your trial, which is a mistake that sometimes reviewers make. It's actually to serve as a guideline for writers, to tell them what information needs to be included in their paper, so that readers can make a decision about how much stock they're going to put in the results. And as I mentioned, there have been several extensions to the CONSORT statement. For example, there's an extension for different sorts of designs like a cluster design, a non-inferiority trials and equivalence trials, and also pragmatic trials. There are extensions for specific types of interventions, such as herbal medicinal interventions, non-pharmacological interventions, and acupuncture interventions. There are some extensions on how to report specific types of data, like harms data, and also on how to do abstracts for papers and abstracts for presentations.