OBJECTIVE: To evaluate the psychometric properties of the C19-YRSm in a prospective sample of people with LC.
METHODS: 1314 patients attending 10 UK specialist LC clinics completed C19-YRSm and EuroQol 5D-5L (EQ-5D-5L) longitudinally. Scale characteristics were derived for C19-YRSm subscales (Symptom Severity (SS), Functional Disability (FD) and Overall Health (OH)) and internal consistency (Cronbach\'s alpha). Convergent validity was assessed using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale. Known groups validity was assessed for the Other Symptoms subscale as tertiles, as well as by hospitalisation and intensive care admission. Responsiveness and test-retest reliability was evaluated for C19-YRSm subscales and EQ-5D-5L. The minimal important difference (MID) and minimal clinically important difference (MCID) were estimated. Confirmatory factor analysis was applied to determine the instrument\'s two-factor structure.
RESULTS: C19-YRSm demonstrated good scale characteristic properties. Item-total correlations were between 0.37 and 0.65 (for SS and FD), with good internal reliability (Cronbach\'s alphas>0.8). Item correlations between subscales ranged between 0.46 and 0.72. Convergent validity with FACIT was good (-0.46 to -0.62). The three subscales discriminated between different levels of symptom burden (p<0.001) and between patients admitted to hospital and intensive care. There was moderate responsiveness for the three subscales ranging from 0.22 (OH) to 0.50 (SS) which was greater than for the EQ-5D-5L. Test-retest reliability was good for both SS 0.86 and FD 0.78. MID was 2 for SS, 2 for FD and 1 for OH; MCID was 4 for both the SS and FD. The factor analysis supported the two-factor SS and FD structure.
CONCLUSIONS: The C19-YRSm is a condition-specific, reliable, valid and responsive patient-reported outcome measure for LC.
目的:评估C19-YRSm在LC患者的前瞻性样本中的心理测量特性。
方法:1314名在10个英国专科LC诊所就诊的患者纵向完成了C19-YRSm和EuroQol5D-5L(EQ-5D-5L)。得出C19-YRSm分量表的量表特征(症状严重程度(SS),功能残疾(FD)和整体健康(OH))和内部一致性(Cronbach'salpha)。使用慢性疾病治疗功能评估(FACIT)-疲劳量表评估收敛效度。已知群体的有效性被评估为“其他症状”子量表,以及住院和重症监护。对C19-YRSm分量表和EQ-5D-5L的反应性和重测信度进行了评估。估计最小重要差异(MID)和最小临床重要差异(MCID)。采用验证性因子分析确定仪器的双因素结构。
结果:C19-YRSm表现出良好的尺度特性。项目总相关性在0.37和0.65之间(对于SS和FD),具有良好的内部可靠性(克朗巴赫的阿尔法>0.8)。子量表之间的项目相关性介于0.46和0.72之间。与FACIT的收敛效度良好(-0.46至-0.62)。三个分量表区分了不同水平的症状负担(p<0.001)以及入院和重症监护的患者。从0.22(OH)到0.50(SS)的三个子量表的反应性中等,高于EQ-5D-5L。SS0.86和FD0.78的重测可靠性均良好。对于SS,MID是2,FD为2,OH为1;SS和FD的MCID均为4。因子分析支持双因子SS和FD结构。
结论:C19-YRSm是一种特定条件,可靠,有效和反应灵敏的患者报告的LC结果测量。