Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index
Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index
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DOI：
10.1046/j.1365-2036.2003.01612.x
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发表时间：
2003-07-01
影响因子：
7.6
通讯作者：
Tack, J
中科院分区：
文献类型：
--
作者：
Revicki, DA;Rentz, AM;Tack, J
工作背景：基于患者的症状评估对于评估胃轻瘫药物治疗的有效性是必要的。目的：总结胃轻瘫基本症状指数（GCSI）的发展和测量质量，这是一种衡量胃轻瘫相关症状的新指标。方法：GCSI是基于对医学文献、临床医生访谈和患者焦点小组的回顾。对169例胃轻瘫患者进行了GCSI测量质量（即信度、效度）的检验。从美国的7个临床中心招募患者参与本观察性研究。患者在基线访视和8周后再次完成GCSI、SF-36健康调查和残疾日问题。临床医生独立地评定患者症状的严重程度，临床医生和患者评定了8周研究中胃肠道相关症状的变化。结果：GCSI包括三个分量表：餐后饱胀/早饱，恶心/呕吐和腹胀。GCSI总分的内部一致性信度为0.84，重测信度为0.76。临床医生评估的症状严重程度与GCSI总分之间存在显著相关性，GCSI评分与SF-36身体和精神成分总分以及活动受限和卧床不起天数之间存在显著相关性。临床医生评定的症状严重程度越高的患者，在GCSI上报告的症状严重程度越高。GCSI总分对临床医生（P = 0.0002）和患者（P = 0.002）评估的胃轻瘫症状的变化有反应。结论：本研究的结果表明，GCSI是一种可靠和有效的工具来衡量胃轻瘫患者的症状严重程度。
Background: Patient-based symptom assessments are necessary to evaluate the effectiveness of medical treatments for gastroparesis.Aim: To summarize the development and measurement qualities of the Gastroparesis Cardinal Symptom Index (GCSI), a new measure of gastroparesis-related symptoms.Methods: The GCSI was based on reviews of the medical literature, clinician interviews and patient focus groups. The measurement qualities (i.e. reliability, validity) of the GCSI were examined in 169 gastroparesis patients. Patients were recruited from seven clinical centres in the USA to participate in this observational study. Patients completed the GCSI, SF-36 Health Survey and disability day questions at a baseline visit and again after 8 weeks. Clinicians independently rated the severity of the patients' symptoms, and both clinicians and patients rated the change in gastroparesis-related symptoms over the 8-week study.Results: The GCSI consists of three sub-scales: post-prandial fullness/early satiety, nausea/vomiting and bloating. The internal consistency reliability was 0.84 and the test-re-test reliability was 0.76 for the GCSI total score. Significant relationships were observed between the clinician-assessed symptom severity and the GCSI total score, and significant associations were found between the GCSI scores and SF-36 physical and mental component summary scores and restricted activity and bed disability days. Patients with greater symptom severity, as rated by clinicians, reported greater symptom severity on the GCSI. The GCSI total scores were responsive to changes in overall gastroparesis symptoms as assessed by clinicians (P = 0.0002) and patients (P = 0.002).Conclusion: The findings of this study indicate that the GCSI is a reliable and valid instrument for measuring the symptom severity in patients with gastroparesis.