A protocol for an international, multicenter, prospective, non-interventional observational registry for patients with hypertriglyceridemia

In the study on triglyceride-induced pancreatitis (TG-IAP), a core clinical dataset using the Jandhyala method was developed to collect the minimum amount of information for each patient presenting with TG-IAP globally. This approach offered a unified framework for observing multiple populations of TG-IAP patients using the same set of indicators, resulting in a considerably larger and uniform real-world population. It was understood that when this core dataset is implemented in a patient registry it could address the issue of missing data in observational studies and produce higher-quality research. In this paper, the protocol used to design and implement a patient registry for this core dataset to generate real-world evidence from multiple sites is described. The study is designed as an international, multicenter, non-interventional, observational registry that will enroll adult patients with hypertriglyceridemia to collect natural history data on the treatment, progression, and long-term outcomes of hypertriglyceridemia-induced acute pancreatitis. Patients with both hypertriglyceridemia and pancreatitis will be invited to participate in the registry at participating hospitals and centers worldwide. Data from this registry, and others like it, is intended for healthcare providers to optimize clinical decision-making through an enhanced understanding of the variability, progression, and natural history of hypertriglyceridemia as well as the burden of disease. Global epidemiological data on hypertriglyceridemia and its role in acute pancreatitis is limited. Using real-world evidence, this registry, along with others like it, may help healthcare providers understand the variability, progression, natural history, and burden of the disease, and improve the diagnosis and management of HTG and TG-IAP.