In many ways, we live by numbers: Weather forecasts tell us what to wear, stock prices tell us how to invest, and digits on a clock tell us when to move from one part of our day to the next. Likewise, numbers are an integral part of clinical medicine and clinical research: Laboratory results, drug doses, and P-values provide essential information regarding patients, treatments, and study findings.
Unfortunately, the meaning of these numbers is not always clear. While drug doses and laboratory results are relatively easy to understand, the statistics in clinical studies are sometimes fairly complicated, often leaving clinicians with a range of unanswered questions: What does a P-value really mean? How should a study’s treatment and control groups be selected? Could a very large treatment group actually lead to misleading results? Why might a therapy that is supported by a rigorous clinical trial still lead to a less-than-optimal outcome in real-world practice?
To answer these questions, clinicians need to understand how clinical trials arrive at their numbers, as this background is what lends meaning to the study’s results. In their article on page 241, Shail M. Govani and Peter D. R. Higgins answer many of these questions. In addition to explaining some of the factors that can impact a study’s results, this article raises important questions that clinicians should consider when evaluating a study. For example: Are the study subjects like my patients? Is the study design biased? Does the study include an intent-to-treat analysis? How were the results measured? While you may already consider many of these questions when reviewing a published clinical trial, Govani and Higgins provide clear and insightful explanations that make this article relevant for anyone who wants to better understand the value of numbers in a clinical trial.
In addition to the article on clinical trial statistics, the current issue of Gastroenterology & Hepatology also includes a feature on cytomegalovirus complicating inflammatory bowel disease, a case of cryoglobulinemia associated with nonalcoholic steatohepatitis, and a case of Chilaiditi syndrome complicated by a closed-loop small bowel obstruction. This month’s columns address several interesting topics: management of anemia in patients receiving protease inhibitors, when to discontinue combination therapy in patients with Crohn’s disease, the pathogenesis of gastroesophageal reflux disease, management of hemobilia, and surgical treatment for obesity.
Finally, moving beyond the boundaries of the printed page, I would like to invite readers to check out our new blog—www.clinicaladvances.wordpress.com—and to follow our new Twitter feed, @clinadvances. Please check out our website and follow us online, as we will be posting timely gastroenterology and hepatology news updates and expanding the discussion about current issues. I invite you to join this conversation, and I look forward to hearing from you.
Sincerely,
Gary R. Lichtenstein, MD, AGAF, FACP, FACG