Endoscopic scoring indices for evaluation of disease activity in Crohn's disease.
Endoscopic scoring indices for evaluation of disease activity in Crohn's disease.
复制标题
DOI：
10.1002/14651858.cd010642.pub2
复制
发表时间：
2016-08-08
期刊：
影响因子：
--
通讯作者：
Levesque, Barrett G
中科院分区：
文献类型：
--
作者：
Khanna, Reena;Nelson, Sigrid A;Levesque, Barrett G
背景技术背景：粘膜疾病活动性的内镜评估被广泛用于确定克罗恩病治疗临床试验的合格性和对治疗的反应。然而，目前可用的内镜指数的操作特性仍不清楚。结论：进行系统回顾以评估克罗恩病内镜严重程度指数（CDEIS）和克罗恩病简易内镜评分（SES-CD）的发展和操作特性。MEDLINE的电子检索（1966年至2015年12月），EMBASE（1980年至2015年12月），以及科克伦对照试验中心（2015年第12期）数据库通过参考文献列表和会议记录的人工审查进行了补充（消化道疾病周，联合欧洲胃肠病周，欧洲克罗恩病和结肠炎组织）。考虑纳入评价克罗恩病患者中CDEIS或SES-CD之一或两者的任何研究设计（例如，随机对照试验、队列研究、病例系列）。符合条件的参与者是成年患者（> 16岁），诊断与克罗恩病使用传统的临床，放射学和内窥镜criterions.DATA收集和分析：两名作者（RK，JKM）独立审查的标题和摘要的文献检索确定的研究。审查了潜在相关引文的全文以纳入，并联系研究者以澄清任何不明确的数据。任何分歧都通过与第三作者讨论和协商一致解决。采用标准化表格评估试验纳入研究的资格和数据提取。两位作者独立提取和记录数据（RK，SAN）。记录每项试验的入组患者数、每个治疗组的患者数、患者特征（包括年龄和性别分布）、内镜指数以及评价者内信度、评价者间信度反应性、效度、可行性、结构效度和标准效度等结果。30项研究中有43份报告符合纳入标准。对于SES-CD，在4项研究中评估了评分者间信度。在SES-CD的开发研究中（Daverno 2004），各区域的总体ICC（0.9815，95% CI 0.9705 - 0.9884）和kappa较高;然而，配对的评定者在同一房间，这引入了偏倚的可能性。对于CDEIS，在6项研究中评估了评定者间可靠性。根据2014年的报告，CDEIS的ICC为0.985（95% CI 0.939-1.000），平均视频评分为0.835（95%CI 0.540-0.995）。在效度方面，CDEIS与临床指标，包括C-反应蛋白（CRP）和红细胞沉降率（ESR）之间的相关性，也被报道。与CRP的相关性估计值分别为r = 0.521（Sipponen 2010 b）、r = 0.553（Sipponen 2008 a）和r = 0.608（Sipponen 2008 c）。对于SES-CD，与CRP相关的相应值范围为r = 0.46（Jones 2008）至r = 0.68（绿色2011）。9项研究中提供了CDEIS的反应性数据。7项研究表明，在给予已知疗效的治疗后，CDEIS评分出现统计学显著性降低。SES-CD的最小反应数据可用。Sipponen 2010 a和Sipponen 2010 b证明，受试者接受已知疗效的治疗后，SES-CD评分发生了统计学显著性变化。未发现明确评价SES-CD或CDEIS可行性的研究。SES-CD需要较少的计算，因此可能比CDEIS更容易使用。专家结论：尽管CDEIS和SES-CD用于临床试验，但它们仍然没有得到完全验证。未来的研究需要确定的操作属性，并定义最佳的指数。
BACKGROUND: Endoscopic assessment of mucosal disease activity is widely used to determine eligibility and response to therapy in clinical trials of treatment for Crohn's disease. However, the operating properties of the currently available endoscopic indices remain unclear.OBJECTIVES: A systematic review was undertaken to evaluate the development and operating characteristics of the Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Scale for Crohn's Disease (SES-CD).SEARCH METHODS: Electronic searches of the MEDLINE (1966 to December 2015), EMBASE (1980 to December 2015), and Cochrane CENTRAL Register of Controlled Trials (Issue 12, 2015) databases were supplemented by manual reviews of reference listings and conference proceedings (Digestive Disease Week, United European Gastroenterology Week, European Crohn's and Colitis Organization).SELECTION CRITERIA: Any study design (e.g. randomized controlled trials, cohort studies, case series) that evaluated either or both the CDEIS or SES-CD in patients with Crohn's disease was considered for inclusion. Eligible participants were adult patients (> 16 years), diagnosed with Crohn's disease using conventional clinical, radiographic, and endoscopic criteria.DATA COLLECTION AND ANALYSIS: Two authors (RK, JKM) independently reviewed the titles and abstracts of the studies identified from the literature search. The full texts of potentially relevant citations were reviewed for inclusion and the study investigators were contacted to clarify any unclear data. Any disagreements were resolved by discussion and consensus with a third author. A standardized form was used to assess eligibility of trials for inclusion in the study and for data extraction.Two authors independently extracted and recorded data (RK, SAN). The number of patients enrolled; number of patients per treatment arm; patient characteristics including age and gender distribution; endoscopic index; and outcomes such as intra-rater reliability, inter-rater reliability responsiveness, validity, feasibility, construct validity, and criterion validity were recorded for each trial.MAIN RESULTS: Forty-three reports of 30 studies fulfilled the inclusion criteria.For the SES-CD, inter-rater reliability was assessed in four studies. In the development study for the SES-CD (Daperno 2004), the overall ICC (0.9815, 95% CI 0.9705 to 0.9884) and the kappa for the regions is high; however the paired raters were in the same room which introduces the potential for bias.For the CDEIS, inter-rater reliability was assessed in six studies. Daperno 2014 reported that the ICC for the CDEIS was 0.985 (95% CI 0.939-1.000) for average measures of video score and was 0.835 (95% CI 0.540-0.995) for single measures of video score.With respect to validity, correlation between the CDEIS and clinical measures, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), was also reported. The estimates of correlation with CRP were r = 0.521 (Sipponen 2010b), r = 0.553 (Sipponen 2008a) and r = 0.608 (Sipponen 2008c). For the SES-CD, the corresponding values for correlation with CRP ranged from r = 0.46 (Jones 2008) to r = 0.68 (Green 2011).Responsiveness data for the CDEIS were available in nine studies. Seven studies demonstrated statistically significant decreases in the CDEIS score after administration of a treatment of known efficacy. Minimal responsiveness data were available for the SES-CD. Sipponen 2010a and Sipponen 2010b demonstrated statistically significant changes in the SES-CD score after subjects were administered a treatment of known efficacy.No studies were identified that explicitly evaluated the feasibility for either the SES-CD or the CDEIS. The SES-CD requires fewer calculations and may therefore be easier to use than the CDEIS.AUTHORS' CONCLUSIONS: Although they are used in clinical trials, the CDEIS and SES-CD remain incompletely validated. Future research is required to determine the operating properties and to define the optimal index.