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

Abstract

Background

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.

Method

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.

Discussion

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.

Conclusion

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.

PLAIN LANGUAGE SUMMARY

In a 2022 study, information was collected from literature, patients, and doctors who care for patients to create a record with the most important information needed to understand patients with a disease called triglyceride-induced acute pancreatitis (TG-IAP). This type of record may help people find patients with the disease and the type of care or treatment they require. The study was started and completed because the doctors used methods to guide and help them understand what needed to be done. This paper describes the method used for this study, including information on:

1. Data collection: how the relevant information about TG-IAP patients was collected;

2. Permissions: how permission was gained to do the study;

3. Patient information: how the information collected about TG-IAP patients will be used; and

4. Patient protection: how the patients who takes part in the study will be protected.

Keywords:

• Triglyceride
• acute pancreatitis
• core dataset
• diagnosis and monitoring
• patient registry

Transparency

Declaration of funding

No funding was received for this work.

Declaration of financial/other relationships

Dr Ravi Jandhyala is a visiting senior lecturer at the Centre for Pharmaceutical Medicine Research at King’s College London and developer of “The Jandhyala method”. He is responsible for researching real-world evidence approaches and is also the founder and CEO of Medialis Ltd, a medical affairs consultancy and contract research organization. Medialis Ltd specializes in the design and delivery of real-world evidence in the pharmaceutical industry. The Jandhyala method is free of commercial licensing restrictions, and, although used as part of proprietary methodology, the author does not profit from this method directly. Co-authors and reviewers named in this manuscript have no relevant relationships to disclose.

Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

RJ conducted the study and prepared, authored, and approved the manuscript. SF, RS, VR, EM, VS, ML, EB, and RJ prepared, authored, and approved the manuscript. The authors affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Acknowledgements

The authors would like to acknowledge the contributions to the development of the core dataset made by the non-author advisors Robert Sutton, Vikesh K. Singh, Michael Davidson, Andres Gelrud, and Chris Forsmark. They would also like to acknowledge the contribution of Medialis personnel (Omolade Femi-Ajao, Radek Wojcik, Brendon Pearce, Mohammed Kabiri, Ziyaad Rahman, and Obuchinezia Anyanwu) to the development of the core dataset and this manuscript. All persons mentioned here have consented to be named.

Data availability statement

The data that support the findings of this study are available from the corresponding author, R. Jandhyala, upon reasonable request.