一项比较克罗恩病患者报告结局的前瞻性研究。
A prospective study comparing patient-reported outcomes in Crohn's disease.
作者信息
Hoekman Daniël R, Löwenberg Mark, van den Brink Gijs R, Ponsioen Cyriel Y, Benninga Marc A, D'Haens Geert R
机构信息
Departments of Gastroenterology and Hepatology.
Pediatric Gastroenterology and Nutrition, Amsterdam University Medical Center, Amsterdam, The Netherlands.
出版信息
Eur J Gastroenterol Hepatol. 2020 Jan;32(1):38-44. doi: 10.1097/MEG.0000000000001568.
BACKGROUND
Patient reported outcomes are important in Crohn's disease. In this prospective cohort, we investigated the performance of the Bristol Stool Form Scale (BSFS) and a visual analog scale (VAS) for abdominal pain as outcome measures in Crohn's disease.
METHODS
Patients with active Crohn's disease starting glucocorticoids or anti-tumor necrosis factor were included. Before treatment and 10 weeks later we collected: clinical activity [Harvey Bradshaw Index (HBI) and Crohn's-Disease-Activity-Index (CDAI)], serum C-reactive protein (CRP) and fecal calprotectin, and BSFS (1-7) and a 100-mm VAS based on a 7-day diary. Clinical response was defined as a reduction by at least 3 and at least 100 of HBI and CDAI, respectively. Fecal calprotectin-response and CRP-response were defined as reduction of at least 50%.
RESULTS
Thirty-eight patients completed follow-up. At baseline, BSFS-parameters correlated more strongly with clinical activity (range: rs: 0.31-0.74) than with CRP (rs: -0.01 to 0.16) and fecal calprotectin (rs: 0.14-0.26). VAS scores correlated very weakly to moderately with clinical activity (rs: 0.18-0.45), and weakly to moderately with CRP (rs: 0.24-0.34) and fecal calprotectin (rs: 0.35-0.43). Changes in VAS scores correlated moderately to strongly (rs: 0.55-0.71) with changes in clinical activity, and weakly with changes in CRP and fecal calprotectin (rs: 0.21-0.35). Changes in BSFS parameters correlated weakly to moderately (rs: 0.23-0.53) with changes in clinical activity, and very weakly to weakly (rs: 0.01-0.35) with changes in CRP and fecal calprotectin. Responsiveness of VAS and BSFS was moderate to high (Guyatt's statistic 0.41-2.17) and highly dependent on the definition of response.
CONCLUSIONS
The BSFS and a VAS appear to be responsive with moderate-to-strong construct validity to monitor patients with Crohn's disease.
背景
患者报告的结局在克罗恩病中很重要。在这项前瞻性队列研究中，我们调查了布里斯托大便形态量表（BSFS）和视觉模拟量表（VAS）用于评估克罗恩病腹痛结局指标的性能。
方法
纳入开始使用糖皮质激素或抗肿瘤坏死因子的活动期克罗恩病患者。在治疗前及10周后，我们收集：临床活动度[哈维·布拉德肖指数（HBI）和克罗恩病活动指数（CDAI）]、血清C反应蛋白（CRP）和粪便钙卫蛋白，以及基于7天日记的BSFS（1 - 7）和100毫米VAS。临床缓解定义为HBI和CDAI分别降低至少3分和至少100分。粪便钙卫蛋白缓解和CRP缓解定义为降低至少50%。
结果
38例患者完成随访。在基线时，BSFS参数与临床活动度的相关性更强（范围：rs：0.31 - 0.74），而与CRP（rs： - 0.01至0.16）和粪便钙卫蛋白（rs：0.14 - 0.26）的相关性较弱。VAS评分与临床活动度的相关性为弱至中度（rs：0.18 - 0.45），与CRP（rs：0.24 - 0.34）和粪便钙卫蛋白（rs：0.35 - 0.43）的相关性为弱至中度。VAS评分的变化与临床活动度的变化相关性为中度至高度（rs：0.55 - 0.
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