Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome

Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome
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DOI:
10.1111/j.1463-1318.2007.01262.x
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发表时间:
2008-01-01
期刊:
影响因子:
3.4
通讯作者:
Piloni, V.
Piloni, V.
中科院分区:
医学3区
文献类型:
--
作者:
Altomare, D. F.;Spazzafumo, L.;Piloni, V.

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目的梗阻性排便综合征(ODS)缺乏客观的评估方法,无法评价疗效或比较包括手术在内的各种治疗方法的疗效。本研究的目的是验证一种疾病的具体指数,量化的严重程度,让评估的结果,在临床试验中的治疗,允许themes.Method 76例ODS和30名健康对照进入研究后,直肠和肛门直肠的生理调查。排除先天性巨结肠和慢传输性便秘。两名独立研究人员在两个不同的时间进行了一份包含八个项目的问卷,其中有四到五个可能的答案。ODS评分是所有分数的总和,最高可能为31分。通过每个单项的Kappa系数评价两名操作员之间的一致性。通过Bland和Altman图评估重复性系数(CR)。通过Crohnbach-alpha检验评价内部一致性。对每个临床发现进行聚类分析。结果两组手术者的ODS评分呈正态分布,相关系数r = 0.89。由两名操作员分配给每个项目的分数之间的相关系数为0.79至0.98。操作者之间的一致性程度良好,两种方法具有重现性(CR = 3.13)。患者组与对照组的ODS评分差异有显著性意义(t = 20.70,P < 0.001)。内部可靠性的Crohnbach α值为+0.513。聚类分析显示,第1类(包括直肠膨出、肠套叠或会阴下降的非同质性组)和第2类(盆腔协同障碍)之间存在差异。结论ODS评分可作为疾病严重程度分级和疗效监测的指标。
Objective There is no objective means to assess the obstructed defaecation syndrome (ODS), to allow evaluation of outcome or to compare the efficacy of treatment including surgery. The study aimed to validate a disease-specific index to quantify severity to allow assessment of the results of treatment in clinical trials, to permit comparison between them.Method Seventy-six patients with ODS and 30 healthy controls entered the study after proctologic and ano-rectal physiological investigation. Hirschsprung's disease and slow transit constipation were excluded. An eight-item questionnaire with four or five possible answers was administered by two independent researchers at two different times. The ODS score was the sum of all points with a maximum possible of 31 points. Agreement between the two operators was evaluated by the Kappa coefficient for each single item. The coefficient of repeatability (CR) was assessed by the Bland and Altman plot. The internal consistency was evaluated by the Crohnbach-alpha test. A cluster analysis was carried out on each clinical finding. The Mann-Whitney U-test was used to compare median ODS score between patients and controls.Results The ODS score of the two operators was normally distributed and strongly correlated (r = 0.89). The correlation coefficient between the score assigned to each item by two operators ranged from 0.79 to 0.98. The degree of agreement between the operators was good and the two methods were reproducible (CR = 3.13). There was a significant difference between the mean ODS score for patients and controls (t = 20.70, P < 0.001). The Crohnbach alpha value for internal reliability was +0.513. Cluster analysis showed a different profile between cluster 1 (a nonhomogenous group including rectocoele, intussusception or perineal descent), and cluster 2 (pelvic dysynergia).Conclusion The ODS score offers a validated severity of disease index in grading the severity of disease and monitoring the efficacy of therapy.