Hahn B A, Kirchdoerfer L J, Fullerton S, Mayer E
Glaxo Wellcome Inc., Research Triangle Park, North Carolina 27709, USA.
Aliment Pharmacol Ther. 1997 Jun;11(3):547-52. doi: 10.1046/j.1365-2036.1997.00168.x.
We describe the development and evaluation of a new disease-specific instrument, the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL), which was designed for use in patients with irritable bowel syndrome. The IBSQOL measures 10 domains found to be relevant to patients with irritable bowel syndrome: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role, and sexual relations.
During its development and evaluation, the IBSQOL was administered to over 500 patients with irritable bowel syndrome--two groups of patients from tertiary care centres, three focus groups of 8-12 patients each, and 287 patients in a national irritable bowel syndrome support network. As a control, the IBSQOL was also administered to 37 patients who did not have irritable bowel syndrome but had other gastrointestinal disorders. Statistical analyses to test the reliability and validity of the IBSQOL were performed using Cronbach's alpha coefficient.
Responses from the focus groups indicated that the IBSQOL was easy to complete and did not require too much time to fill out (approximately equal to 25 min). Statistical analyses of the final 30-item version of the IBSQOL demonstrated that it had both adequate validity and reliability (alpha > or = 0.60). A comparison of mean IBSQOL scores of persons with and without irritable bowel syndrome (but with other gastrointestinal conditions) showed no difference between the two groups with irritable bowel syndrome; however, scores for both irritable bowel syndrome groups were considerably lower than for the non-irritable bowel syndrome group, suggesting better health-related quality of life in patients who do not have irritable bowel syndrome. This further demonstrated the validity of the IBSQOL in targeting questions and domains specific to patients with irritable bowel syndrome.
Evaluation of the IBSQOL included testing the questionnaire in a large number of patients, which resulted in a revised and well-constructed instrument that demonstrated both adequate validity and reliability. The IBSQOL is currently being used in large-scale clinical trials to measure changes in quality of life in patients with irritable bowel syndrome following treatment intervention.
我们描述了一种新的疾病特异性工具——肠易激综合征生活质量问卷（IBSQOL）的开发与评估，该问卷专为肠易激综合征患者设计。IBSQOL测量了10个被认为与肠易激综合征患者相关的领域：情绪健康、心理健康、健康信念、睡眠、精力、身体功能、饮食、社会角色、身体角色和性关系。
在其开发和评估过程中，IBSQOL被应用于500多名肠易激综合征患者——两组来自三级护理中心的患者、三个每组8 - 12名患者的焦点小组以及全国肠易激综合征支持网络中的287名患者。作为对照，IBSQOL也被应用于37名没有肠易激综合征但患有其他胃肠道疾病的患者。使用克朗巴哈α系数进行统计分析以检验IBSQOL的信度和效度。
焦点小组的反馈表明IBSQOL易于完成，填写不需要太多时间（大约25分钟）。对IBSQOL最终30项版本的统计分析表明它具有足够的效度和信度（α≥0.60）。对患有和未患有肠易激综合征（但患有其他胃肠道疾病）的人群的IBSQOL平均得分进行比较，结果显示两组肠易激综合征患者之间没有差异；然而，两个肠易激综合征组的得分都显著低于非肠易激综合征组，这表明没有肠易激综合征的患者健康相关生活质量更好。这进一步证明了IBSQOL在针对肠易激综合征患者特有的问题和领域方面的效度。
IBSQOL的评估包括在大量患者中对问卷进行测试，这产生了一个经过修订且结构良好的工具，该工具显示出足够的效度和信度。IBSQOL目前正在大规模临床试验中用于测量治疗干预后肠易激综合征患者生活质量的变化。
