Malaty Hoda M, Abudayyeh Suhaib, O'Malley Kimberly J, Wilsey Michael J, Fraley Ken, Gilger Mark A, Hollier David, Graham David Y, Rabeneck Linda
Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
Pediatrics. 2005 Feb;115(2):e210-5. doi: 10.1542/peds.2004-1412.
Recurrent abdominal pain (RAP) is a common problem in children and adolescents. Evaluation and treatment of children with RAP continue to challenge physicians because of the lack of a psychometrically sound measure for RAP. A major obstacle to progress in research on RAP has been the lack of a biological marker for RAP and the lack of a reliable and valid clinical measure for RAP. The objectives of this study were (1) to develop and test a multidimensional measure for RAP (MM-RAP) in children to serve as a primary outcome measure for clinical trials, (2) to evaluate the reliability of the measure and compare its responses across different populations, and (3) to examine the reliabilities of the measure scales in relation to the demographic variables of the studied population.
We conducted 3 cross-sectional studies. Two studies were clinic-based studies that enrolled children with RAP from 1 pediatric gastroenterology clinic and 6 primary care clinics. The third study was a community-based study in which children from 1 elementary and 2 middle schools were screened for frequent episodes of abdominal pain. The 3 studies were conducted in Houston, Texas. Inclusion criteria for the clinic-based studies were (1) age of 4 to 18 years; (2) abdominal pain that had persisted for 3 or more months; (3) abdominal pain that was moderate to severe and interfered with some or all regular activities; (4) abdominal pain that may or may not be accompanied by upper-gastrointestinal symptoms; and (5) children were accompanied by a parent or guardian who was capable of giving informed consent, and children over the age of 10 years were capable of giving informed assent. The community-based study used standardized questionnaires that were offered to 1080 children/parents from the 3 participating schools; 700 completed and returned the questionnaires (65% response rate). The questionnaire was designed to elicit data concerning the history of abdominal pain or discomfort. A total of 160 children met Apley's criteria and were classified as having RAP. Inclusion criteria were identical to those criteria for the clinic-based studies. Participating children in the 3 studies received a standardized questionnaire that asked about socioeconomic variables, abdominal pain (intensity; frequency; duration; nature of abdominal pain, if present, and possible relationships with school activities; and other upper gastrointestinal symptoms). We used 4 scales for the MM-RAP: pain intensity scale (3 items), nonpain symptoms scale (12 items), disability scale (3 items), and satisfaction scale (2 items). Age 7 was used as a cutoff point for the analysis as the 7-year-olds have been shown to exhibit more sophisticated knowledge of illness than younger children.
A total of 295 children who were aged 4 to 18 years participated in the study: 155 children from the pediatric gastroenterology clinics, 82 from the primary care clinics, and 58 from the schools. The interitem consistency (Cronbach's coefficient alpha) for the pain intensity items, nonpain symptoms items, disability items, and satisfaction items were 0.75, 0.81, 0.80, and 0.78, respectively, demonstrating good reliability of the measure. The internal consistencies of the 4 scales did not significantly differ between younger (< or =7 years) and older (>7 years) children. There was also no significant variation in the coefficient alpha of each of the 4 scales in relation to gender or the level of the parent's education. Reliability was identical for the pain-intensity items (0.74) among children who sought medical attention from primary care or pediatric gastroenterology clinics. The intercorrelations of factor scores among the 4 scales showed a strong relationship among the factors but not high enough that correlations would be expected to be measuring the same items. The results of the factor analysis identified 5 components instead of 4 components representing the 4 scales. The 12 items of the nonpain symptoms scale were classified into 2 components; 1 component included heartburn, burping, passing gas, bloating, problem with ingestion of milk, bad breath, and sour taste (nonpain symptoms I), and the other included nausea/vomiting, diarrhea, and constipation (nonpain symptoms II). The program ordered the 5 components on the basis of the percentage of the total variance explained by each component and consequently by the strength of each components in the following order: nonpain symptoms I, pain intensity, pain disability, satisfaction, and nonpain symptoms II. Of the 20 items that composed the MM-RAP, 17 met the inclusion criteria of having a correlation of > or =0.40 on the primary factor analyses. The 3 items that assessed pain intensity met the inclusion criteria as well as the 2 items that assessed satisfaction. Two of the 3 items that assessed disability met the inclusion criteria; however, the missed school item did not. The sleep problem and the loss of appetite items in the nonpain items also did not meet the inclusion criteria in both components of the nonpain symptoms scale. However, the loss of appetite item met the inclusion criteria in the disability scale with a correlation of 0.6. The 2 items that did not meet the inclusion criteria (missed school days and sour taste) will be eliminated in the revised measure for RAP.
The MM-RAP demonstrated good reliability evidence in population samples. Children who have RAP and are seen at pediatric gastroenterology or primary care pediatric clinics have similar responses, showing that the measure performed well across several populations. Age did not affect the reliability of responses. The MM-RAP included 4 dimensions, each with several items that may identify disease-specific dimensions. In addition, dividing the nonpain symptoms scale into 2 components instead of 1 component could assist in creating a disease-specific measure. The present study focused exclusively on developing the multidimensional measure for RAP in children that could assist physicians in evaluating the efficacy of RAP treatment independent of psychological evaluations. In addition, the measure was designed for use in clinical trials that evaluate the efficacy of RAP treatment and to allow comparison between intervention studies. In conclusion, we were able to identify 4 dimensions of RAP in children (pain intensity, nonpain symptoms, pain disability, and satisfaction with health). We demonstrated that these dimensions can be measured in a reliable manner that is applicable to children who experience RAP in various settings.
复发性腹痛(RAP)是儿童和青少年中的常见问题。由于缺乏针对RAP的心理测量学上完善的测量方法,对患有RAP的儿童进行评估和治疗仍然是医生面临的挑战。RAP研究进展的一个主要障碍是缺乏RAP的生物学标志物以及缺乏可靠且有效的RAP临床测量方法。本研究的目的是:(1)开发并测试一种针对儿童RAP的多维测量方法(MM-RAP),作为临床试验的主要结局指标;(2)评估该测量方法的可靠性,并比较不同人群的反应;(3)研究测量量表的可靠性与所研究人群的人口统计学变量之间的关系。
我们进行了3项横断面研究。两项研究是以诊所为基础的研究,从1家儿科胃肠病诊所和6家初级保健诊所招募患有RAP的儿童。第三项研究是基于社区的研究,对来自1所小学和2所中学的儿童进行频繁腹痛筛查。这3项研究在德克萨斯州休斯顿进行。基于诊所的研究的纳入标准为:(1)年龄4至18岁;(2)腹痛持续3个月或更长时间;(3)腹痛为中度至重度,干扰部分或全部日常活动;(4)腹痛可能伴有或不伴有上消化道症状;(5)儿童由能够给予知情同意的父母或监护人陪同,10岁以上的儿童能够给予知情同意。基于社区的研究使用标准化问卷,向来自3所参与学校的1080名儿童/父母发放;700份问卷填写并返回(回复率65%)。该问卷旨在获取有关腹痛或不适病史的数据。共有160名儿童符合阿普雷标准,被归类为患有RAP。纳入标准与基于诊所的研究的标准相同。3项研究中的参与儿童均收到一份标准化问卷,询问社会经济变量、腹痛(强度、频率、持续时间、腹痛性质(如存在)以及与学校活动的可能关系)和其他上消化道症状。我们为MM-RAP使用了4个量表:疼痛强度量表(3项)、非疼痛症状量表(12项)、残疾量表(3项)和满意度量表(2项)。将7岁作为分析的分界点,因为已表明7岁儿童对疾病的认识比年幼儿童更复杂。
共有295名4至18岁的儿童参与了研究:155名来自儿科胃肠病诊所,82名来自初级保健诊所,58名来自学校。疼痛强度项目、非疼痛症状项目、残疾项目和满意度项目的项目间一致性(克朗巴赫系数α)分别为0.75、0.81、0.80和0.78,表明该测量方法具有良好的可靠性。4个量表的内部一致性在年龄较小(≤7岁)和年龄较大(>7岁)的儿童之间没有显著差异。4个量表中每个量表的系数α在性别或父母教育水平方面也没有显著差异。在从初级保健或儿科胃肠病诊所寻求医疗护理的儿童中,疼痛强度项目的可靠性相同(0.74)。4个量表之间的因子得分的相互相关性表明各因子之间存在很强的关系,但相关性还不够高,以至于预期它们测量的是相同的项目。因子分析的结果确定了5个成分,而不是代表4个量表的4个成分。非疼痛症状量表的12个项目被分为2个成分;1个成分包括烧心、打嗝、排气、腹胀、摄入牛奶问题、口臭和酸味(非疼痛症状I),另一个包括恶心/呕吐、腹泻和便秘(非疼痛症状II)。该程序根据每个成分解释的总方差百分比以及因此每个成分的强度,按以下顺序对5个成分进行排序:非疼痛症状I、疼痛强度、疼痛残疾、满意度和非疼痛症状II。构成MM-RAP的20个项目中,有17个在主因子分析中符合相关性≥0.40的纳入标准。评估疼痛强度的3个项目以及评估满意度的2个项目符合纳入标准。评估残疾的3个项目中有2个符合纳入标准;然而,缺课项目不符合。非疼痛项目中的睡眠问题和食欲不振项目在非疼痛症状量表的两个成分中也均不符合纳入标准。然而,食欲不振项目在残疾量表中符合纳入标准,相关性为0.6。在修订的RAP测量方法中,将排除2个不符合纳入标准的项目(缺课天数和酸味)。
MM-RAP在人群样本中显示出良好的可靠性证据。在儿科胃肠病或初级保健儿科诊所就诊的患有RAP的儿童有相似的反应,表明该测量方法在多个人群中表现良好。年龄不影响反应的可靠性。MM-RAP包括4个维度,每个维度有几个项目,可能识别疾病特异性维度。此外,将非疼痛症状量表分为2个成分而不是1个成分有助于创建疾病特异性测量方法。本研究专门致力于开发针对儿童RAP的多维测量方法,该方法可帮助医生在不依赖心理评估的情况下评估RAP治疗的疗效。此外,该测量方法设计用于评估RAP治疗疗效的临床试验,并允许在干预研究之间进行比较。总之,我们能够识别儿童RAP的4个维度(疼痛强度、非疼痛症状、疼痛残疾和对健康的满意度)。我们证明这些维度可以通过可靠的方式进行测量,适用于在各种环境中经历RAP的儿童。