Teferi Mekonnen, Leanne Staniford, Spencer Connell, Zofia Das-Gupta, Umanga DeSilva, Yasmine Saoud, Isabel Miller, Mohapradeep Mohan, Simon Nienhuijs, Megha Poddar, Vaishali Chetan Deshmukh, Marli Conradie-Smit, Soo Huat Teoh, Sanjeev Sockalingam, Emilia Huvinen, Paolo Sbraccia, Ronald Liem, Michael Vallis, Kenneth Clare, Tracy Zvenyach, Karen Coulman, Marianela Aguirre Ackermann, Verónica Vázquez-Velázquez, Yudith Preiss Contreras, Josep Vidal, Agbo Urudinachi, María Fernanda Tejeda-Muñoz, Ian Patton, T Alafia Samuels, Morgan Emile Gabriel Salmon Leguede, Georgia Rigas, Ximena Ramos Salas, Michael Crotty, Bruno Halpern, Daniel Bessesen, Laura Pizzi, Omniyat Mohammed Al Hajeri, Arya M Sharma
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引用次数: 0
Abstract
Background: Obesity is a chronic disease linked to over 200 health conditions, reduced quality of life, and increased mortality. Despite the availability of multimodal treatments, there is a lack of standardised, patient-centred outcome measures to effectively assess and improve clinical care. This project aimed to define a core set of standardised outcome measures for adults with obesity, incorporating both patient-reported and clinician-reported outcomes. Additional objectives included determining the optimal measurement frequency and identifying case-mix variables essential for risk adjustment.
Methods: The International Consortium for Health Outcomes Measurement (ICHOM) established the Obesity Working Group (OWG), composed of 29 international experts and individuals living with obesity. Members were selected based on their expertise in obesity care and research and represented 21 countries. The development process, conducted from May 2023 to July 2024, began with a kick-off meeting to define scope, followed by eight virtual meetings. A comprehensive literature review informed the identification of relevant clinical outcomes, patient-reported outcomes, treatment-related complications, and case-mix variables. A three-round Delphi process was used to reach consensus on key outcomes and follow-up intervals. Outcomes were included in the final set if at least 80% of OWG members rated them between 7 and 9 on a 9-point scale. Validation was conducted through surveys with 95 patients and 106 healthcare professionals from fields such as dietetics, obesity medicine, and general practice.
Findings: The OWG developed a standardised set of 20 outcome measures, comprising 17 core measures and 3 population-specific measures. These span domains including physical health, psychosocial well-being, health behaviours, body functioning, and adverse events. Specific measures were also developed for bariatric surgery and female reproductive health (both pregnant and non-pregnant individuals). Key case-mix factors and appropriate follow-up periods were defined to support global consistency in reporting.
Interpretation: Adoption of this standardised outcome set enables clinicians, patients, and stakeholders to identify care gaps, monitor outcomes, and evaluate the quality of obesity care against global benchmarks. Implementation can support the creation of a robust international data resource to guide research, inform clinical practice, and shape policy and guidelines for adult obesity treatment. Limitations include limited geographical diversity in validation surveys, the exclusion of internalised weight bias due to a lack of validated measurement tools, and limited applicability to individuals with obesity and multiple comorbidities.
Funding: Novo Nordisk, Eli Lilly, and Boehringer Ingelheim International GmbH.
期刊介绍：
eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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