How Does Outcomes Research Help Advance Our Knowledge of Patient Outcomes in Hepatopancreaticobiliary Surgery?

Abstract

Randomized controlled trials have historically been regarded as the gold standard of modern clinical research tools, allowing us to elucidate the efficacy of novel therapeutics in an unparalleled manner. However, when attempting to generalize trial results to broader populations, it becomes apparent that the unexplained outcome variability exists among treatment recipients, suggesting that randomized controlled trials harbor inherent limitations. Herein, we explore the benefits of health services (outcomes) research utilization in addressing variation in patient outcomes following surgical intervention in the nonrandomized setting, with a specific focus on hepatopancreaticobiliary surgery outcomes. To achieve this, we have constructed a framework that outlines the complex interactions existing between therapeutic, patient, and provider factors that subsequently lead to variation in outcomes. By exploring examples in the current literature, we have highlighted the areas where the knowledge is currently lacking and can be further strengthened through the application of outcomes research. Furthermore, we have attempted to demonstrate the utility of alternative study designs in the investigation of novel clinical questions currently unanswered in the field of hepatopancreaticobiliary surgery.Keywords Health services research . Outcomes . Pancreas . Hepatopancreaticobiliary surgeryIn the era of modern medicine, randomized controlled trials (RCTs) have played an integral role in elucidating the efficacy of breakthrough therapeutic modalities. More recently, health services (outcomes) research has risen as another form of research methodology. Outcomes research may be even more valuable in a subspecialized field such as hepatopancreaticobiliary (HPB) surgery, in which RCTs are less commonplace than in other subspecialties, likely due to lower overall incidence rates of pathology and limited availability of study participants.