Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.
School of Medicine, Tulane University, New Orleans, LA, USA.
Pharmacoeconomics. 2019 Jul;37(7):921-929. doi: 10.1007/s40273-019-00775-8.
Health utility decrements associated with diabetes mellitus complications are essential for calculating quality-adjusted life-years (QALYs) in patients for use in economic evaluation of diabetes interventions. Previous studies mostly focused on assessing the impact of complications on health utility at event year based on cross-sectional data. This study aimed to separately estimate health utility decrements associated with current and previous diabetes complications.
The Health Utilities Index Mark 3 (HUI-3) was used to measure heath utility in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N = 8713). Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss]) were included in a set of alternative modelling approaches including the ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements.
All macrovascular complications were associated with decrements of HUI-3 scores: MI (event year: - 0.042, successive years: - 0.011), CHF (event year: - 0.089, successive years: - 0.041), stroke (event year: - 0.204, successive years: - 0.101), angina (event year: - 0.010, successive years: - 0.032), and revascularization (event year: - 0.038, successive years: - 0.016) (all p < 0.05). For microvascular complications, severe vision loss (- 0.057), and severe pressure sensation loss (- 0.066) were significantly associated with decrements of HUI-3 scores (both p < 0.05). Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years. Results from an OLS model are preferred for supporting a microsimulation model while a fixed effects model is preferred to describe direct health impacts from complications.
Macrovascular and microvascular complications caused QALY decrements in patients with type 2 diabetes. While only part of the total impaired QALY is experienced during the event year, further QALY decrements for successive years were quite substantial.
评估糖尿病相关并发症对健康效用的影响,对于计算糖尿病患者的质量调整生命年(QALYs)并用于糖尿病干预的经济评估至关重要。先前的研究主要集中在基于横断面数据评估并发症对健康效用的影响。本研究旨在分别评估当前和既往糖尿病并发症与健康效用下降的关系。
在心血管风险行动研究(ACCORD)试验(N=8713)中,采用健康效用指数 Mark 3 量表(HUI-3)测量健康效用。共纳入 5 种大血管并发症(心肌梗死[MI]、充血性心力衰竭[CHF]、中风、心绞痛和血管重建手术[RS])和 3 种微血管并发症(肾病[肾衰竭]、视网膜病变[严重视力丧失]和神经病变[严重压力感觉丧失]),并纳入一系列替代建模方法,包括最小二乘法(OLS)模型、固定效应模型和随机效应模型,以估计与并发症相关的健康效用下降。
所有大血管并发症均与 HUI-3 评分下降相关:MI(事件年:-0.042,连续年:-0.011)、CHF(事件年:-0.089,连续年:-0.041)、中风(事件年:-0.204,连续年:-0.101)、心绞痛(事件年:-0.010,连续年:-0.032)和血管重建(事件年:-0.038,连续年:-0.016)(均 P<0.05)。对于微血管并发症,严重视力丧失(-0.057)和严重压力感觉丧失(-0.066)与 HUI-3 评分下降显著相关(均 P<0.05)。低血糖(严重和症状性)与事件年 0.036 的健康效用下降和连续年 0.033 的健康效用下降相关。OLS 模型的结果更适合支持微观模拟模型,而固定效应模型更适合描述并发症的直接健康影响。
2 型糖尿病患者的大血管和微血管并发症导致 QALY 下降。虽然在事件年内仅经历了总受损 QALY 的一部分,但连续数年的 QALY 下降幅度相当大。