纳什检查的验证:一种新型患者报告的非酒精性脂肪肝炎的结果测量方法
James Twiss1, Diane Whalley2, Lynda Doward2
1RTI Health Solutions, Manchester, M20 2LS, UK. jtwiss@rti.org.
Journal of patient-reported outcomes
|July 14, 2023
概括
纳什检查 (NASH-CHECK) 是一种新的患者报告结果测量方法,可靠且有效地评估临床试验中非酒精性脂肪肝炎 (NASH) 患者的症状和生活质量.
科学领域:
- 肝病学和胃肠病学 肝病学和胃肠学
- 患者报告的结果
- 临床试验方法论 临床试验方法论
背景情况:
- 对于评估非酒精性脂肪肝炎 (NASH) 临床试验中的患者体验,存在有限的标准化措施.
- 一种患者报告的结果 (PRO) 测量,NASH-CHECK,被开发用于评估NASH患者的症状和与健康有关的生活质量.
- 这项研究旨在量化评估NASH-CHECK测量的心理特征.
研究的目的:
- 为了评估NASH-CHECK测量的心理测量特性.
- 为了确定NASH-CHECK的最佳得分.
- 评估NASH-CHECK等级分数的可靠性,构造有效性和检测变化的能力.
主要方法:
- 利用了成年NASH患者2期随机对照试验 (NCT02855164) 的数据.
- 进行了项目级别的分析,包括相关性和探索性因子分析,导致删除了三个项目.
- 进行了确认因素分析,以建立多项和单项等级,随后进行了心理分析.
主要成果:
- 最终的NASH-CHECK测量包括四个多项表 (认知症状,活动限制,社会影响,情绪影响) 和五个单项表 (腹痛,胀气,疲劳,睡眠,皮肤).
- 心理测量分析证实了NASH-CHECK尺度的内部可靠性,测试-重新测试可靠性,构造有效性和响应性.
- 分析了253名NASH患者的数据 (61%为女性,平均年龄为53岁).
结论:
- 纳什检查 (NASH-CHECK) 是一种可靠,有效和响应的措施,用于评估患者报告的纳什症状和生活质量.
- 该措施适用于评估NASH治疗的临床试验.
- 纳什检查也可以在常规的临床实践中用于评估患者的观点.
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