Long-term follow-up of the red density pilot trial: a basis for long-term prediction of sustained clinical remission in ulcerative colitis?

IF 5.9 1区 哲学 Q1 BUSINESS Journal of Business Ethics Pub Date : 2023-09-27 eCollection Date: 2023-09-01 DOI:10.1055/a-2153-7210
Pieter Sinonquel, Peter Bossuyt, João Pedro Guedelha Sabino, Bram Verstockt, Takao Makino, Severine Vermeire, Raf Bisschops
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Abstract

Red density (RD) technology is an automated operator-independent endoscopic scoring system for disease activity in ulcerative colitis (UC). In this retrospective analysis we aimed to assess the predictive value of the RD sore for sustained clinical remission. All 39 patients from the RD pilot trial were evaluated for clinical outcome in a 5-year period. The highest RD score was considered for Receiver operating characteristic (ROC) analysis to determine the cut-off of the RD for the composite endpoint of treatment failure (defined as mortality, colectomy, hospitalizations, flares and UC therapy changes). Statistical significance was considered P < 0.05. Reassessment of the RD score was possible in 36 patients. The composite endpoint was reached in 17 of 39 patients. ROC analysis for clinical remission showed a RD cut-off of 65, area under the ROC was 0.68, sensitivity of 0.71, and a specificity of 0.63. A RD score of ≥ 65 demonstrated a statistically non-significant increase in composite endpoint (hazard ratio 0.49 (95% confidence interval 0.1871-1.280); P = 0.1453). In conclusion, the RD score may be an independent predictor of clinical remission in patients with UC for the disease course up to 5 years, but results of the ongoing PROCEED-UC trial are to awaited for definite conclusions.

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红色密度试点试验的长期随访:溃疡性结肠炎持续临床缓解的长期预测依据?
红色密度(RD)技术是一种独立于操作者的内窥镜自动评分系统,用于评估溃疡性结肠炎(UC)的疾病活动性。在这项回顾性分析中,我们旨在评估红色密度疮对持续临床缓解的预测价值。我们对 RD 试点试验的所有 39 名患者进行了为期 5 年的临床结果评估。Receiver operating characteristic (ROC) 分析考虑了最高的 RD 评分,以确定治疗失败(定义为死亡率、结肠切除术、住院、复发和 UC 治疗改变)综合终点的 RD 临界值。统计学意义以 P < 0.05 为准。有 36 名患者的 RD 评分得到了重新评估。39名患者中有17名达到了综合终点。临床缓解的 ROC 分析显示,RD 临界值为 65,ROC 下面积为 0.68,灵敏度为 0.71,特异度为 0.63。RD 评分≥ 65 分时,复合终点的增加无统计学意义(危险比为 0.49(95% 置信区间为 0.1871-1.280);P = 0.1453)。总之,RD评分可能是预测UC患者病程长达5年的临床缓解的独立指标,但仍需等待正在进行的PROCEED-UC试验的结果才能得出明确结论。
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来源期刊
CiteScore
12.80
自引率
9.80%
发文量
265
期刊介绍: The Journal of Business Ethics publishes only original articles from a wide variety of methodological and disciplinary perspectives concerning ethical issues related to business that bring something new or unique to the discourse in their field. Since its initiation in 1980, the editors have encouraged the broadest possible scope. The term `business'' is understood in a wide sense to include all systems involved in the exchange of goods and services, while `ethics'' is circumscribed as all human action aimed at securing a good life. Systems of production, consumption, marketing, advertising, social and economic accounting, labour relations, public relations and organisational behaviour are analysed from a moral viewpoint. The style and level of dialogue involve all who are interested in business ethics - the business community, universities, government agencies and consumer groups. Speculative philosophy as well as reports of empirical research are welcomed. In order to promote a dialogue between the various interested groups as much as possible, papers are presented in a style relatively free of specialist jargon.
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