Burisch Johan, Zhang He, Choong Casey Kar-Chan, Nelson David, Naegeli April, Gibble Theresa, Goetz Iris, Egeberg Alexander
Gastrounit, Medical Division, Hvidovre University Hospital, Kettegårdsalle 30, Capital Region, 2650, Denmark.
Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Therap Adv Gastroenterol. 2021 Mar 31;14:17562848211004841. doi: 10.1177/17562848211004841. eCollection 2021.
BACKGROUND & AIMS: There are currently no validated claims-based indicators for identifying a worsening of disease in patients with inflammatory bowel disease (IBD). Therefore, we aimed to develop and validate indicators that identify flare-ups of IBD using data from Danish nationwide registries.
Using Danish nationwide administrative data, we identified all patients with Crohn's disease (CD) or ulcerative colitis (UC) who had at least one measurement of faecal calprotectin between 1 January 2015 and 31 June 2017. We tested several different claims-based indicators of disease flare-ups against levels of faecal (F-)calprotectin (no flare-up: <250 mg/kg; mild flare-up: 250-1000 mg/kg; severe flare-up: ⩾1000 mg/kg). A generalised estimating equation was used to evaluate whether the proposed indicators could predict disease activity.
A total of 890 children and 4719 adults with CD, and 592 children and 5467 adults with UC were included in the study. During the observation period, 48-61% and 48-55% of the CD and UC patients, respectively, had no flare-up, 26-29% (CD) and 24-26% (UC) experienced a mild flare-up, and 12-23% (CD) and 21-27% (UC) experienced a severe flare-up. Combinations of indicators that could predict a flare-up in CD and UC adults included hospitalisation, surgery, initiation or switch of biological therapy, treatment with systemic steroids, locally acting steroids or topical 5-aminosalicylates, colonoscopy/sigmoidoscopy, and magnetic resonance imaging/computed tomography. In children, only the number of gastroenterology visits was significant as an indicator among UC patients, and none were seen in children with CD. Overall, the indicator combinations resulted in a predictive ability of 0.62-0.67.
Administrative claims data can be useful for identifying patients exhibiting (F-calprotectin defined) flare-ups of their IBD. Clinically relevant events captured in the Danish national patient registry are associated with increased levels of calprotectin and hence increased disease activity, and can be used as valid outcomes in future studies.
目前尚无经过验证的基于索赔数据的指标用于识别炎症性肠病（IBD）患者的疾病恶化情况。因此，我们旨在利用丹麦全国性登记处的数据开发并验证能够识别IBD发作的指标。
利用丹麦全国性行政数据，我们确定了所有在2015年1月1日至2017年6月31日期间至少进行过一次粪便钙卫蛋白检测的克罗恩病（CD）或溃疡性结肠炎（UC）患者。我们针对粪便（F-）钙卫蛋白水平（无发作：<250mg/kg；轻度发作：250 - 1000mg/kg；重度发作：⩾1000mg/kg）测试了几种不同的基于索赔数据的疾病发作指标。采用广义估计方程来评估所提出的指标是否能够预测疾病活动。
本研究共纳入890名患有CD的儿童和4719名患有CD的成人，以及592名患有UC的儿童和5467名患有UC的成人。在观察期内，分别有48 - 61%的CD患者和48 - 55%的UC患者无发作，26 - 29%（CD）和24 - 26%（UC）经历轻度发作，12 - 23%（CD）和21 - 27%（UC）经历重度发作。能够预测CD和UC成年患者发作的指标组合包括住院、手术、生物治疗的起始或转换、全身用类固醇、局部用类固醇或局部5 - 氨基水杨酸酯治疗、结肠镜检查/乙状结肠镜检查以及磁共振成像/计算机断层扫描。在儿童中，仅UC患者的胃肠病就诊次数作为指标具有显著性，而CD儿童中未发现显著指标。总体而言，指标组合的预测能力为0.62 - 0.67。
行政索赔数据有助于识别表现出（由钙卫蛋白定义的）IBD发作的患者。丹麦国家患者登记处记录的临床相关事件与钙卫蛋白水平升高相关，进而与疾病活动增加相关，并且可在未来研究中用作有效结局指标。
