Robarts Clinical Trials Inc., University of Western Ontario, London, ON, Canada.
Department of Epidemiology and Biostatistics, University of Western Ontario, London, ON, Canada.
J Crohns Colitis. 2018 Jan 24;12(2):167-177. doi: 10.1093/ecco-jcc/jjx130.
Crohn's disease-related complications account for a substantial proportion of inflammatory bowel disease-associated health care expenditure. Identifying patients at risk for complications may allow for targeted use of early therapeutic interventions to offset this natural course. We aimed to develop risk prediction models for Crohn's disease-related surgery and complications.
Using data from the Randomised Evaluation of an Algorithm for Crohn's Disease cluster-randomised clinical Trial [REACT], which involved 1898 patients from 40 community practices, separate prediction models were derived and internally validated for predicting Crohn's disease-related surgery and disease-related complications [defined as the first disease-related surgery, hospitalisation, or complication within 24 months]. Model performance was assessed in terms of discrimination and calibration, decision curves, and net benefit analyses.
There were 130 [6.8%] disease-related surgeries and 504 [26.6%] complications during the 24-month follow-up period. Selected baseline predictors of surgery included age, gender, disease location, Harvey-Bradshaw Index [HBI] score, stool frequency, antimetabolite or 5-aminosalicylate use, and the presence of a fistula, abscess, or abdominal mass. Selected predictors of complications included those same factors for surgery, plus corticosteroid or anti-tumour necrosis factor use, but excluded 5-aminosalicylate use. Discrimination ability, as measured by validated c-statistics, was 0.70 and 0.62 for the surgery and complication models, respectively. Score charts and nomograms were developed to facilitate future risk score calculation.
Separate risk prediction models for Crohn's disease-related surgery and complications were developed using clinical trial data involving community gastroenterology practices. These models could be used to guide Crohn's disease management. External validation is warranted.
克罗恩病相关并发症占炎症性肠病相关医疗支出的很大一部分。识别有并发症风险的患者可能有助于有针对性地早期使用治疗干预措施来改变这种自然病程。我们旨在开发克罗恩病相关手术和并发症的风险预测模型。
使用来自随机评估克罗恩病算法的社区实践群组随机临床试验（REACT）的数据，该试验涉及来自 40 个社区实践的 1898 名患者，分别为预测克罗恩病相关手术和疾病相关并发症（定义为 24 个月内的第一次与疾病相关的手术、住院或并发症）建立了预测模型，并进行了内部验证。通过区分度和校准、决策曲线和净收益分析来评估模型性能。
在 24 个月的随访期间，发生了 130 例（6.8%）与疾病相关的手术和 504 例（26.6%）并发症。手术的选定基线预测因素包括年龄、性别、疾病部位、Harvey-Bradshaw 指数（HBI）评分、粪便频率、抗代谢物或 5-氨基水杨酸的使用，以及瘘管、脓肿或腹部肿块的存在。并发症的预测因素包括手术的相同因素，加上皮质类固醇或抗肿瘤坏死因子的使用，但排除了 5-氨基水杨酸的使用。经验证的 c 统计量衡量的区分能力，手术和并发症模型分别为 0.70 和 0.62。开发了评分图表和诺模图，以方便未来风险评分的计算。
使用涉及社区胃肠病学实践的临床试验数据开发了克罗恩病相关手术和并发症的单独风险预测模型。这些模型可用于指导克罗恩病的管理。需要进行外部验证。
