Adam B, Liebregts T, Saadat-Gilani K, Vinson B, Holtmann G
Department of Gastroenterology, Hepatology and General Internal Medicine, Royal Adelaide Hospital, University of Adelaide, Australia.
Aliment Pharmacol Ther. 2005 Aug 15;22(4):357-63. doi: 10.1111/j.1365-2036.2005.02572.x.
To validate the gastrointestinal symptom score as an outcome measure for functional dyspepsia.
In focus groups, 10 dyspepsia-specific items including nausea, sickness, vomiting, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, epigastric pain/upper abdominal pain were identified. Ninety-five patients with functional dyspepsia and 56 healthy controls were recruited and responsiveness evaluated by analysing gastrointestinal symptom score data from 357 patients from previous placebo-controlled trials. Gastrointestinal symptom score response data were correlated with the patient's global assessments of efficacy. Convergent validity was assessed by correlating the gastrointestinal symptom score with the results obtained by the Nepean Dyspepsia Index.
Sensitivity: In patients and healthy controls gastrointestinal symptom score yielded consistently different scores (all P < 0.0001). TEST-RETEST RELIABILITY: Gastrointestinal symptom score determined at the two time points were significantly correlated (r-values ranging from 0.842 to 0.901). CONVERGENCE VALIDITY: Gastrointestinal symptom score of both rating groups were significantly correlated with the symptom-specific component of the Nepean Dyspepsia Index (r-vales ranging from 0.666 to 0.764, P < 0.01). RESPONSIVENESS: Responses of gastrointestinal symptom score during treatment were different for patients with a global self assessment as responders compared with non-responders (all P < 0.0055).
The gastrointestinal symptom score is a valid and reliable instrument to assess symptom intensities in patients with functional dyspepsia.
验证胃肠道症状评分作为功能性消化不良的一项疗效指标。
在焦点小组中，确定了10项消化不良特异性症状，包括恶心、呕吐、反胃、腹胀、腹部绞痛、早饱、反酸/烧心、食欲不振、胸骨后不适、上腹部疼痛。招募了95例功能性消化不良患者和56名健康对照者，并通过分析来自之前安慰剂对照试验的357例患者的胃肠道症状评分数据来评估反应性。将胃肠道症状评分反应数据与患者对疗效的整体评估进行关联。通过将胃肠道症状评分与内佩恩消化不良指数的结果进行关联来评估收敛效度。
敏感性：在患者和健康对照者中，胃肠道症状评分始终存在差异（所有P<0.0001）。重测信度：在两个时间点测定的胃肠道症状评分显著相关（r值范围为0.842至0.901）。收敛效度：两个评分组的胃肠道症状评分均与内佩恩消化不良指数的症状特异性成分显著相关（r值范围为0.666至0.764，P<0.01）。反应性：与无反应者相比，整体自我评估为有反应者的患者在治疗期间胃肠道症状评分的反应不同（所有P<0.0055）。
胃肠道症状评分是评估功能性消化不良患者症状强度的有效且可靠的工具。
