Abstract
Purpose
Bariatric and metabolic surgery is an effective treatment for severe and complex obesity, however, robust long-term data comparing operations is lacking. Clinical registries complement clinical trials in contributing to this evidence base. Agreement on standard data for bariatric registries is needed to facilitate comparisons. This study developed a Core Registry Set (CRS) – core data to include in bariatric surgery registries globally.
Materials and Methods
Relevant items were identified from a bariatric surgery research core outcome set, a registry data dictionary project, systematic literature searches, and a patient advisory group. This comprehensive list informed a questionnaire for a two-round Delphi survey with international health professionals. Participants rated each item's importance and received anonymized feedback in Round 2. Using pre-defined criteria, items were then categorized for voting at a consensus meeting to agree the CRS.
Results
Items identified from all sources were grouped into 97 questionnaire items. Professionals (n=272) from 56 countries participated in the round 1 survey of which 45% responded to round 2. Twenty-four professionals from 13 countries participated in the consensus meeting. Twelve items were voted into the CRS including demographic and bariatric procedure information, effectiveness, and safety outcomes.
Conclusion
This CRS is the first step towards unifying bariatric surgery registries internationally. We recommend the CRS is included as a minimum dataset in all bariatric registries worldwide. Adoption of the CRS will enable meaningful international comparisons of bariatric operations. Future work will agree definitions and measures for the CRS including incorporating quality-of-life measures defined in a parallel project.
Bariatric and metabolic surgery is an effective treatment for severe and complex obesity, however, robust long-term data comparing operations is lacking. Clinical registries complement clinical trials in contributing to this evidence base. Agreement on standard data for bariatric registries is needed to facilitate comparisons. This study developed a Core Registry Set (CRS) – core data to include in bariatric surgery registries globally.
Materials and Methods
Relevant items were identified from a bariatric surgery research core outcome set, a registry data dictionary project, systematic literature searches, and a patient advisory group. This comprehensive list informed a questionnaire for a two-round Delphi survey with international health professionals. Participants rated each item's importance and received anonymized feedback in Round 2. Using pre-defined criteria, items were then categorized for voting at a consensus meeting to agree the CRS.
Results
Items identified from all sources were grouped into 97 questionnaire items. Professionals (n=272) from 56 countries participated in the round 1 survey of which 45% responded to round 2. Twenty-four professionals from 13 countries participated in the consensus meeting. Twelve items were voted into the CRS including demographic and bariatric procedure information, effectiveness, and safety outcomes.
Conclusion
This CRS is the first step towards unifying bariatric surgery registries internationally. We recommend the CRS is included as a minimum dataset in all bariatric registries worldwide. Adoption of the CRS will enable meaningful international comparisons of bariatric operations. Future work will agree definitions and measures for the CRS including incorporating quality-of-life measures defined in a parallel project.
Original language | English |
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Pages (from-to) | 1463–1475 |
Number of pages | 13 |
Journal | Obesity Surgery |
Volume | 33 |
Issue number | 5 |
Early online date | 24 Mar 2023 |
DOIs | |
Publication status | Published - 1 May 2023 |
Bibliographical note
Funding Information:We would like to thank Manuela Mazzarella (IFSO Chief Operating Officer) for helping with administration of the study including the Delphi survey, as well as IFSO member societies for advertising the survey. We thank Professor Jamie Kirkham (University of Manchester) for his expertise in independently chairing the consensus meeting, and the PPI group for their input into the questionnaire items. We would like to acknowledge the support of the IFSO Global Registry committee: Wendy Brown, Ronald Liem, Jacques Himpens, Mario Musella, Nasser Sakran, Villy Vage, Salman Al Sabah, Ricardo Cohen, John Morton, Amir Ghaferi, Mehran Anvari, Lilian Kow, Francois Pattou, Camilo Boza, Kelvin Higa, Almino Ramos. Finally, we would like to thank all professionals who gave up their time to part in the Delphi survey and consensus meeting.
Funding Information:
This study was funded by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and supported by the Royal College of Surgeons of England Bristol Surgical Trials Centre and the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust (BRC-1215–20011). KD Coulman, Clinical Lecturer (ICA-CL-2018–04-ST2-008), is funded by Health Education England (HEE) / National Institute for Health Research (NIHR) and The Bristol Centre for Surgical Research and The NIHR Biomedical Research Centre (various grants) at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the authors and not necessarily those of the NIHR, NHS, the UK Department of Health and Social Care, or the Royal College of Surgeons of England.
Publisher Copyright:
© 2023, The Author(s).
Research Groups and Themes
- HEHP@Bristol
- Centre for Surgical Research