Longworth Louise, Buxton Martin J, Sculpher Mark, Smith David H
Health Economics Research Group, Brunel University, UK.
Eur J Health Econ. 2005 Dec;6(4):347-53. doi: 10.1007/s10198-005-0309-y.
This study estimated a model from which data routinely collected in clinical trials of angina patients can be mapped to a utility scale and used to estimate quality-adjusted life years (QALYs). Patients with stable angina attending four cardiac out-patient clinics in the UK were included in the study. Data collected included information on patients' health-related quality of life (HRQL) using the EQ-5D, and severity of angina symptoms using two cardiac-specific measures [Breathlessness Grade and Canadian Cardiovascular Society (CCS) classification of angina]. Regression analysis was used to predict EQ-5D index values from the data. Data were obtained from 510 patients. For CCS grades, mean EQ-5D scores ranged from 0.36 (95% confidence interval 0.25-0.48) for grade 4 to 0.81 (0.77-0.85) for grade 0, and for breathlessness grades, EQ-5D scores ranged from 0.31 (0.06-0.55) for grade 0 to 0.84 (0.79-0.88) for grade 5. The final model used data on CCS grades, breathlessness grades, and patients' current medications to predict EQ-5D scores. The model had an R2 value of 0.37, and predictions for less severe angina were considered more reliable than the estimates for severe angina. In the absence of utility data collected as part of a clinical trial it is possible to map HRQL utility data from samples of patients with similar characteristics to those in the original trial. The uncertainty surrounding the estimates should be considered when using the results to estimate QALYs for purposes of economic evaluation.
本研究估计了一个模型,通过该模型,可将在心绞痛患者临床试验中常规收集的数据映射到效用量表,并用于估计质量调整生命年(QALY)。纳入研究的是在英国四家心脏门诊就诊的稳定型心绞痛患者。收集的数据包括使用EQ-5D评估的患者健康相关生活质量(HRQL)信息,以及使用两种心脏特异性指标[呼吸困难分级和加拿大心血管学会(CCS)心绞痛分级]评估的心绞痛症状严重程度。采用回归分析从这些数据预测EQ-5D指数值。数据来自510名患者。对于CCS分级,EQ-5D平均得分范围为4级的0.36(95%置信区间0.25 - 0.48)至0级的0.81(0.77 - 0.85);对于呼吸困难分级,EQ-5D得分范围为0级的0.31(0.06 - 0.55)至5级的0.84(0.79 - 0.88)。最终模型使用CCS分级、呼吸困难分级和患者当前用药数据来预测EQ-5D得分。该模型的R2值为0.37,对较轻心绞痛的预测被认为比重症心绞痛的估计更可靠。在没有作为临床试验一部分收集的效用数据的情况下,可以将具有与原始试验患者相似特征的样本中的HRQL效用数据进行映射。在使用结果估计QALY以进行经济评估时,应考虑估计值周围的不确定性。