Khanna Dinesh, Hays Ron D, Park Grace S, Braun-Moscovici Yolanda, Mayes Maureen D, McNearney Terry A, Hsu Vivien, Clements Philip J, Furst Daniel E
University of Cincinnati, the Veterans Affairs Medical Center, Cincinnati, Ohio, USA.
Arthritis Rheum. 2007 Oct 15;57(7):1280-6. doi: 10.1002/art.22987.
Gastrointestinal tract (GIT) involvement occurs in approximately 90% of patients with systemic sclerosis (SSc) and has a major impact on health-related quality of life (HRQOL). We developed an HRQOL instrument for persons with SSc.
The Scleroderma Gastrointestinal Tract 1.0 (SSC-GIT 1.0) survey was developed after an extensive literature search, solicitation and consideration of experts' opinions, and 2 focus groups of 16 subjects with SSc and GIT involvement. A 75-item, self-reported measure assessing bowel involvement, emotional well-being, and social functioning was administered to subjects with SSc and GIT involvement. Also, subjects completed the Short Form 36 and rated the severity of their GIT symptoms (very mild to very severe), and items were transformed linearly to a scale with a possible range of 0 (worse health) to 100 (better health). Evaluation of psychometric properties included internal consistency reliability, test-retest reliability (1.3-week median time interval), multitrait scaling analysis, and exploratory factor analysis.
Study participants (n = 88) were primarily female (95.5%), white (79.3%), and had a mean age of 52.4 years. Self-rated severity of GIT involvement ranged from very mild or mild (36.0%) to moderate (44.0%) to severe or very severe (20.0%). Of 75 items, 23 had low item-total correlations (</=0.39) and were excluded, leaving a 52-item instrument. Analyses supported 6 multi-item HRQOL scales: reflux/indigestion, diarrhea, constipation, pain, emotional well-being, and social functioning. Test-retest reliability estimates ranged 0.69-0.90 and Cronbach's alpha ranged 0.69-0.93. Participants who rated their GIT disease as mild had the highest scores (better health) on all 6 scales; participants who rated their GIT as severe had the lowest scores (poor health).
The results support the reliability and validity of the SSC-GIT 1.0 as a measure of SSc GIT involvement. Further research is needed to examine the ability to detect change over time and define minimally important differences.
胃肠道（GIT）受累见于约90%的系统性硬化症（SSc）患者，对健康相关生活质量（HRQOL）有重大影响。我们为SSc患者开发了一种HRQOL工具。
在广泛检索文献、征求并考虑专家意见以及对16名有GIT受累的SSc患者进行2次焦点小组讨论后，制定了硬皮病胃肠道1.0（SSC-GIT 1.0）调查问卷。对有GIT受累的SSc患者进行一项包含75个项目的自我报告测量，评估肠道受累情况、情绪健康和社会功能。此外，受试者完成简短健康调查问卷36项版本（Short Form 36）并对其GIT症状的严重程度进行评分（从非常轻微到非常严重），各项目线性转换为一个范围从0（健康状况较差）到100（健康状况较好）的量表。心理测量学特性评估包括内部一致性信度、重测信度（中位时间间隔为1.3周）、多特质量表分析和探索性因子分析。
研究参与者（n = 88）主要为女性（95.5%）、白人（79.3%），平均年龄为52.4岁。自我评定的GIT受累严重程度范围从非常轻微或轻度（36.0%）到中度（44.0%）再到重度或非常重度（20.0%）。75个项目中，23个项目与总分的相关性较低（≤0.39），被排除，最终形成一个包含52个项目的工具。分析支持6个多项目HRQOL量表：反流/消化不良、腹泻、便秘、疼痛、情绪健康和社会功能。重测信度估计值范围为0.69 - 0.90，克朗巴哈系数范围为0.69 - 0.93。将其GIT疾病评定为轻度的参与者在所有6个量表上得分最高（健康状况较好）；将其GIT评定为重度的参与者得分最低（健康状况较差）。
结果支持SSC-GIT 1.0作为评估SSc患者GIT受累情况的可靠性和有效性。需要进一步研究以检验其随时间检测变化的能力并确定最小重要差异。
