Big Data vs. Clinical Trials in HPB Surgery.

Randomized controlled clinical trials (RCTs) are at the heart of "evidence-based" medicine. However, in surgical practice, RCTs remain uncommon. Conducting well-designed RCTs for surgical procedures is often challenged by inadequate recruitment accrual, blinding, or standardization of the surgical procedure, as well as lack of funding and evolution of the treatment strategy during the many years over which such trials are conducted. In addition, most clinical trials are performed in academic high-volume centers in highly selected patients, which may not necessarily reflect a "real-world" practice setting. Over the past decades, surgical outcomes research using nationwide administrative and registry databases has become increasingly common. Large databases provide easy and inexpensive access to data on a large and diverse patient population at a variety of treatment centers. Furthermore, large database studies provide the opportunity to answer questions that would be impossible or very arduous to answer using RCTs, including questions regarding health policy efficacy, trends in surgical practice, access to health care, impact of hospital volume, and adherence to practice guidelines, as well as research questions regarding rare disease, infrequent surgical outcomes, and specific subpopulation. Prospective data registries may also allow for quality benchmarking and auditing. This review outlines the role, advantages, and limitations of RCTs and large database studies in answering important research questions in surgery.