Rentz A M, Battista C, Trudeau E, Jones R, Robinson P, Sloan S, Mathur S, Frank L, Revicki D A
Center for Health Outcomes Research, MEDTAP International, Inc, Bethesda, Maryland 20814, USA.
Pharmacoeconomics. 2001;19(4):349-63. doi: 10.2165/00019053-200119040-00003.
Patient-rated symptom and health-related quality-of-life (HR-QOL) outcomes are important end-points for clinical trials of medical treatments for gastrointestinal (GI) disorders. Based on this review, patient outcomes research is focused on gastroesophageal reflux disease and dyspepsia, with a growing interest in irritable bowel syndrome but little research in gastroparesis. State-of-the-art for patient-rated symptom scales is rudimentary with an abundance of scales and little attention to systematic instrument development or comprehensive psychometric evaluation. Generally, disease-specific HR-QOL measures have been more systematically developed and evaluated psychometrically, but few have been incorporated into clinical trials. More comprehensive outcome assessments are needed to determine the effectiveness of new medical treatments for functional GI disorders. Future clinical trials of GI disorders should combine clinician assessments of outcomes and symptoms with patient-rated symptom and HR-QOL end-points.
患者自评症状及健康相关生活质量（HR-QOL）结果是胃肠道（GI）疾病医学治疗临床试验的重要终点。基于本综述，患者结局研究主要集中在胃食管反流病和消化不良，对肠易激综合征的兴趣日益增加，但对胃轻瘫的研究较少。患者自评症状量表的现状尚不完善，量表众多，但很少关注系统的工具开发或全面的心理测量评估。一般来说，针对特定疾病的HR-QOL测量方法在心理测量方面得到了更系统的开发和评估，但很少被纳入临床试验。需要更全面的结局评估来确定新的医学治疗对功能性胃肠疾病的有效性。未来的胃肠疾病临床试验应将临床医生对结局和症状的评估与患者自评症状及HR-QOL终点相结合。
