排便梗阻综合征新评分系统的建立与统计学验证

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

作者信息

Altomare D F, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V

机构信息

Department of Emergency and Organ Transplantation, General Surgery and Liver transplantation Units, University of Bari, Bari, Italy.

出版信息

Colorectal Dis. 2008 Jan;10(1):84-8. doi: 10.1111/j.1463-1318.2007.01262.x. Epub 2007 Apr 18.

DOI:10.1111/j.1463-1318.2007.01262.x

PMID:17441968

Abstract

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.

摘要

目的

目前尚无客观方法来评估排便梗阻综合征（ODS），从而无法对治疗结果进行评估，也无法比较包括手术在内的各种治疗方法的疗效。本研究旨在验证一种针对该疾病的指数，以量化疾病严重程度，从而能够在临床试验中评估治疗结果，并可在不同治疗方法之间进行比较。

方法

76例ODS患者和30名健康对照者在接受直肠肛管生理检查后进入研究。排除先天性巨结肠和慢传输型便秘患者。由两名独立研究人员在两个不同时间发放一份包含4或5个可能答案的8项问卷。ODS评分是所有得分的总和，最高可达31分。通过卡帕系数评估两名操作人员对每个单项的一致性。通过Bland-Altman图评估重复性系数（CR）。通过Cronbach-α检验评估内部一致性。对每项临床发现进行聚类分析。采用Mann-Whitney U检验比较患者和对照者的ODS评分中位数。

结果

两名操作人员的ODS评分呈正态分布且相关性很强（r = 0.89）。两名操作人员对每个项目的评分之间的相关系数在0.79至0.98之间。操作人员之间的一致性程度良好，两种方法具有可重复性（CR = 3.13）。患者和对照者的平均ODS评分之间存在显著差异（t = 20.70，P < 0.001）。内部可靠性的Cronbach α值为+0.513。聚类分析显示第1组（包括直肠膨出、肠套叠或会阴下降的非同质组）和第2组（盆底协同失调）之间存在不同的特征。