Bruinsma Floris F E, Hurme Saija, Peterli Ralph, Stenberg Erik, Nienhuijs Simon W, Grönroos Sofia, Våge Villy, Bueter Marco, Ottosson Johan, Liem Ronald S L, Salminen Paulina
Department of Surgery, Maastricht University Medical Centre, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands.
Scientific Bureau, Dutch Institute for Clinical Auditing, Leiden, The Netherlands.
Br J Surg. 2025 May 31;112(6). doi: 10.1093/bjs/znaf106.
The Swiss-Finnish Bariatric Metabolic Outcome Score (SF-BARI Score), based on merged data of two RCTs, is a composite endpoint designed to evaluate and categorize outcomes after metabolic bariatric surgery (MBS). The aim of this study was to externally validate the score using registry data.
Individual patient data were included from the Dutch Audit for Treatment of Obesity, the Scandinavian Obesity Surgery Registries (SOReg-Sweden and SOReg-Norway), and the merged RCT data used for establishing the SF-BARI Score. All patients undergoing primary MBS from January 2010 to June 2018, with complete baseline characteristics, as well as complete 1- and 5-year follow-up data, were included. The mean total score and distribution were compared between the combined registry and merged RCT data.
There was no statistically significant difference in the mean SF-BARI Score between the registries (21 603 patients) and merged RCTs (457 patients) at 5 years (90.9 versus 89.1 points; difference = 1.8 (95% c.i. -1.0 to 4.7); P = 0.212), and the score distribution was similar. Statistically significant differences in baseline characteristics existed regarding sex (male 20.9% versus 29.3%), type 2 diabetes (16.7% versus 33.9%), hypertension (30.4% versus 66.1%), dyslipidaemia (13.7% versus 46.5%), obstructive sleep apnoea syndrome (12.0% versus 17.4%), and sleeve gastrectomy (SG) rate (21.0% versus 49.9%) (P < 0.001). The mean score estimate at 5 years in Roux-en-Y gastric bypass was 11.2 (95% c.i. 10.2 to 12.2) points higher compared with SG (P < 0.001).
This study verified the feasibility of the SF-BARI Score, enabling standardized reporting and allowing for comparison of different treatment modalities.
基于两项随机对照试验(RCT)合并数据的瑞士-芬兰肥胖症代谢结局评分(SF-BARI评分)是一个复合终点指标,旨在评估代谢性肥胖症手术(MBS)后的结局并进行分类。本研究的目的是使用登记数据对该评分进行外部验证。
纳入了来自荷兰肥胖症治疗审计、斯堪的纳维亚肥胖症手术登记处(瑞典SOReg和挪威SOReg)的个体患者数据,以及用于建立SF-BARI评分的RCT合并数据。纳入了2010年1月至2018年6月期间接受初次MBS且具有完整基线特征以及完整的1年和5年随访数据的所有患者。比较了联合登记处数据和RCT合并数据之间的平均总分及分布情况。
在5年时,登记处(21603例患者)和RCT合并数据(457例患者)之间的平均SF-BARI评分无统计学显著差异(分别为90.9分和89.1分;差值 = 1.8(95%置信区间 -1.0至4.7);P = 0.212),且评分分布相似。在性别(男性20.9%对29.3%)、2型糖尿病(16.7%对33.9%)、高血压(30.4%对66.1%)、血脂异常(13.7%对46.5%)、阻塞性睡眠呼吸暂停综合征(12.0%对17.4%)以及袖状胃切除术(SG)率(21.0%对49.9%)方面,基线特征存在统计学显著差异(P < 0.001)。与SG相比,Roux-en-Y胃旁路术5年时的平均评分估计值高11.2分(95%置信区间10.2至12.2)(P < 0.001)。
本研究验证了SF-BARI评分的可行性,可实现标准化报告并允许对不同治疗方式进行比较进行比较。