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The association between disease activity and patient-reported outcomes in patients with moderate-to-severe ulcerative colitis in the United States and Europe.
BMC Gastroenterology ( IF 2.5 ) Pub Date : 2020-01-21 , DOI: 10.1186/s12876-020-1164-0
Alessandro Armuzzi 1 , Miriam Tarallo 2 , James Lucas 3 , Daniel Bluff 3 , Benjamin Hoskin 3 , Danielle Bargo 4 , Joseph C Cappelleri 5 , Leonardo Salese 6 , Marco daCosta DiBonaventura 4
Affiliation  

BACKGROUND Patients with ulcerative colitis (UC) experience periods of recurring and episodic clinical signs and symptoms. This study sought to establish the association between disease activity and health-related quality of life (HRQoL) and other patient-reported outcomes. METHODS United States (US) and European Union 5 ([EU5]; i.e., France, Germany, Italy, Spain, and the United Kingdom) data from the 2015 and 2017 Adelphi Inflammatory Bowel Disease-Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of retrospective patient chart information integrated with patient survey data (EuroQoL-5 Dimensions [EQ-5D], Short Quality of Life in Inflammatory Bowel Disease Questionnaire [SIBDQ], and Work Productivity and Activity Impairment-Ulcerative Colitis [WPAI-UC] questionnaire). Using available chart information, physicians classified their moderate-to-severe patients into one of the following categories: remission with a Mayo endoscopic score = 0 ("deep remission"), remission without a Mayo endoscopic score = 0 ("remission"), or active disease. Differences among disease activity categories with respect to patient-reported outcomes were analyzed using generalized linear models, controlling for confounding variables. RESULTS N = 289 and N = 1037 patient charts with linked surveys were included from the US and EU5, respectively. The disease activity distribution was as follows: active disease = 40.1% (US) and 33.6% (EU5); remission = 48.0 and 53.0%; deep remission = 11.9 and 13.3%. Patients with active disease reported significantly lower levels of EQ-5D health state utilities (adjusted mean [AdjM] = 0.87 [US] and 0.78 [EU5]) compared with remission (AdjM = 0.92 and 0.91) and deep remission (AdjM = 0.93 and 0.91) (all P < 0.05 compared with active disease within each region). Similar findings were observed with the scores from the SIBDQ and the WPAI-UC. No significant differences were observed between remission categories. CONCLUSIONS Among patients with moderate-to-severe UC in the US and EU5, active disease was associated with significant impairments in HRQoL, work and leisure activities. These results reinforce the importance, to both the patient and society, of achieving some level of remission to restore generic and disease-related HRQoL and one's ability to work productively.

中文翻译:

在美国和欧洲,中至重度溃疡性结肠炎患者的疾病活动性与患者报告的结局之间的关联。

背景技术溃疡性结肠炎(UC)患者经历复发和发作性临床体征和症状的时期。这项研究试图建立疾病活动与健康相关的生活质量(HRQoL)与其他患者报告的结局之间的关联。方法使用2015年和2017年阿德菲炎症性肠病专项计划(IBD-DSP)的美国(US)和欧盟5([EU5];即法国,德国,意大利,西班牙和英国)数据。IBD-DSP是与患者调查数据(EuroQoL-5维度[EQ-5D],炎性肠病问卷中的短生命质量[SIBDQ]以及工作生产率和活动障碍-溃疡性结肠炎)相结合的回顾性患者病历信息数据库[WPAI-UC]问卷)。使用可用的图表信息,医生将其中度至重度患者分为以下类别之一:Mayo内镜评分= 0的缓解(“深度缓解”),Mayo内镜评分= 0的缓解(“缓解”)或活动性疾病。使用广义线性模型,控制混杂变量,分析了患者报告的疾病活动类别之间的差异。结果分别包括美国和欧盟5国的289例患者和1037例具有链接调查的患者图表。疾病活动性分布如下:活动性疾病= 40.1%(美国)和33.6%(EU5);缓解率= 48.0和53.0%; 深度缓解率= 11.9%和13.3%。活动性疾病患者的EQ-5D健康状态效用水平显着降低(调整后的平均值[AdjM] = 0.87 [US]和0。78 [EU5])与缓解(AdjM = 0.92和0.91)和深度缓解(AdjM = 0.93和0.91)相比(所有P <0.05,与每个地区的活动性疾病相比)。SIBDQ和WPAI-UC的分数也观察到了类似的发现。在缓解类别之间未观察到显着差异。结论在美国和EU5中度至重度UC患者中,活动性疾病与HRQoL,工作和休闲活动明显受损有关。这些结果增强了对患者和社会的重要性,以达到一定程度的缓解,以恢复通用的和与疾病相关的HRQoL以及一个人的生产能力。SIBDQ和WPAI-UC的分数也观察到了类似的发现。在缓解类别之间未观察到显着差异。结论在美国和EU5中度至重度UC患者中,活动性疾病与HRQoL,工作和休闲活动明显受损有关。这些结果增强了对患者和社会的重要性,达到一定程度的缓解以恢复通用的和与疾病相关的HRQoL以及一个人的生产能力。SIBDQ和WPAI-UC的分数也观察到了类似的发现。在缓解类别之间未观察到显着差异。结论在美国和EU5中度至重度UC患者中,活动性疾病与HRQoL,工作和休闲活动明显受损有关。这些结果增强了对患者和社会的重要性,以达到一定程度的缓解,以恢复通用的和与疾病相关的HRQoL以及一个人的生产能力。
更新日期:2020-01-22
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