Mekonnen Teferi, Staniford Leanne, Connell Spencer, Das-Gupta Zofia, DeSilva Umanga, Saoud Yasmine, Miller Isabel, Mohan Mohapradeep, Nienhuijs Simon, Poddar Megha, Deshmukh Vaishali Chetan, Conradie-Smit Marli, Teoh Soo Huat, Sockalingam Sanjeev, Huvinen Emilia, Sbraccia Paolo, Liem Ronald, Vallis Michael, Clare Kenneth, Zvenyach Tracy, Coulman Karen, Ackermann Marianela Aguirre, Vázquez-Velázquez Verónica, Contreras Yudith Preiss, Vidal Josep, Urudinachi Agbo, Tejeda-Muñoz María Fernanda, Patton Ian, Samuels T Alafia, Gabriel Salmon Leguede Morgan Emile, Rigas Georgia, Salas Ximena Ramos, Crotty Michael, Halpern Bruno, Bessesen Daniel, Pizzi Laura, Al Hajeri Omniyat Mohammed, Sharma Arya M
Nordic Institute of Dental Materials and Norwegian Institute of Public Health, Norway.
Lancaster University, England.
EClinicalMedicine. 2025 Aug 20;87:103422. doi: 10.1016/j.eclinm.2025.103422. eCollection 2025 Sep.
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.
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.
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.
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.
Novo Nordisk, Eli Lilly, and Boehringer Ingelheim International GmbH.
肥胖是一种慢性疾病，与200多种健康状况、生活质量下降和死亡率增加有关。尽管有多种治疗方法，但缺乏标准化的、以患者为中心的结局指标来有效评估和改善临床护理。该项目旨在为肥胖成年人定义一套核心标准化结局指标，纳入患者报告结局和临床医生报告结局。其他目标包括确定最佳测量频率以及识别风险调整所需的病例组合变量。
国际健康结局测量联盟（ICHOM）成立了肥胖工作组（OWG），由29名国际专家和肥胖患者组成。成员根据其在肥胖护理和研究方面的专业知识选拔，代表21个国家。从2023年5月至2024年7月进行的制定过程，始于一次启动会议以确定范围，随后召开了八次虚拟会议。全面的文献综述为确定相关临床结局、患者报告结局、治疗相关并发症和病例组合变量提供了依据。采用三轮德尔菲法就关键结局和随访间隔达成共识。如果至少80%的OWG成员在9分制中给某项结局打分为7至9分，则该结局纳入最终指标集。通过对95名患者以及来自营养学、肥胖医学和全科医学等领域的106名医疗保健专业人员进行调查来进行验证。
OWG制定了一套标准化的20项结局指标，包括17项核心指标和3项特定人群指标。这些指标涵盖身体健康、心理社会福祉、健康行为、身体功能和不良事件等领域。还针对减肥手术以及女性生殖健康（包括孕妇和非孕妇）制定了具体指标。定义了关键病例组合因素和适当的随访期，以支持报告的全球一致性。
采用这套标准化结局指标能使临床医生、患者和利益相关者识别护理差距、监测结局，并对照全球基准评估肥胖护理质量。实施该指标可支持创建一个强大的国际数据资源，以指导研究、为临床实践提供信息，并塑造成人肥胖治疗的政策和指南。局限性包括验证调查中的地理多样性有限、由于缺乏经过验证的测量工具而未纳入内化的体重偏见，以及对患有肥胖症和多种合并症的个体适用性有限。
诺和诺德公司、礼来公司和勃林格殷格翰国际有限公司。
