Development of a core outcome set for recurrent acute and chronic pancreatitis: Results of a Delphi poll - PubMed (original) (raw)

Development of a core outcome set for recurrent acute and chronic pancreatitis: Results of a Delphi poll

Lola Rahib et al. Pancreatology. 2024 Dec.

Abstract

Background/objective: Recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP) lack effective therapies. There is no consensus or guidance on which endpoints or outcome measures should be used in clinical trials. This study aimed to develop a core outcome set aligned with both patient and provider priorities for RAP and CP. Utilizing the Outcomes Measures in Rheumatology (OMERACT) framework, a multi-stakeholder approach was adopted to identify and prioritize outcome domains.

Methods: A two-round Delphi poll was conducted among four stakeholder groups: adult patients, parents and pediatric patients, adult health care providers and pediatric health care providers. Steering committee consensus further refined the core outcome domains, categorizing them as mandatory, important but optional, or research agenda domains, with full consensus achieved.

Results: Pain severity, ability to participate in social roles and activities, pancreatitis related hospitalization/ER visits and acute pancreatitis flare-ups were recommended as mandatory outcome domains for future clinical trials in RAP/CP.

Conclusions: Using the OMERACT framework, we developed a core outcome set for RAP and CP. Future research will focus on identifying validated measures for each domain, facilitating standardized assessments across clinical trials.

Keywords: Chronic pancreatitis; Core outcome sets; Recurrent acute pancreatitis.

Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.

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Conflict of interest statement

Declaration of competing interest The authors declare no conflicts of interest for this article.

Figures

Figure 1:

Figure 1:

Flowchart of participant results in each round

Figure 2:

Figure 2:

Round 2 ranking by stakeholder group. Analysis of Round 2 surveys assessed the importance of each domain and its comparative ranking within each stakeholder group. Ranking is 1-5 with 1 being most important.

Figure 3:

Figure 3:

Final consensus on domains for core outcome set for recurrent acute and chronic pancreatitis. The committee aligned domains with the OMERACT 2.0 framework, classifying them into three categories: mandatory, important but optional, or research agenda domains. Underlined research agendas were added by the Committee.

References

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