Sullivan Mark D, Anderson Roger T, Aron David, Atkinson Hal H, Bastien Arnaud, Chen G John, Feeney Patricia, Gafni Amiram, Hwang Wenke, Katz Lois A, Narayan K M, Nwachuku Chuke, O'Connor Patrick J, Zhang Ping
Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington 98195-6560, USA.
Am J Cardiol. 2007 Jun 18;99(12A):90i-102i. doi: 10.1016/j.amjcard.2007.03.027. Epub 2007 Apr 13.
Diabetes mellitus affects not only life expectancy but also quality of life. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial's health-related quality of life (HRQOL) and cost-effectiveness components will enable the assessment of the relative importance of the various outcomes from the point of view of patients, provide an understanding of the balance between the burdens and benefits of the intervention strategies, and offer valuable insights into adherence. The HRQOL measures used include the Diabetes Symptoms Distress Checklist; the 36-Item Short Form Health Survey, Version 2 (SF-36) (RAND Corporation, Santa Monica, CA); the Patient Health Questionnaire (PHQ) depression measure (Pfizer Inc, New York, NY); the World Health Organization (WHO) Diabetes Treatment Satisfaction Questionnaire (DTSQ); and the EuroQol Feeling Thermometer (EuroQol Group, Rotterdam, Netherlands). The cost-effectiveness analysis (CEA) in ACCORD will provide information about the relative economic efficiency of the different interventions being compared in the trial. Effectiveness will be measured in terms of cardiovascular event-free years gained and quality-adjusted life-years gained (using the Health Utilities Index Mark 3 [HUI-3] [Health Utilities Inc., Dundas, Ontario, Canada] to measure health-state utility). Costs will be direct medical costs assessed from the perspective of a single-payer health system collected by means of patient and clinic cost forms and hospital discharge summaries. The primary HRQOL and CEA hypotheses mirror those in the main ACCORD trial, addressing the effects of the 3 main ACCORD interventions considered separately. There are also secondary (pairwise reference case) comparisons that do not assume independence of treatment effects on HRQOL. CEA will be done on a subsample of 4,311 ACCORD participants and HRQOL on a subsample of 2,053 nested within the CEA subsample. Most assessments will occur through questionnaires at baseline and at 12, 36, and 48 months.
糖尿病不仅会影响预期寿命，还会影响生活质量。糖尿病心血管风险控制行动（ACCORD）试验中的健康相关生活质量（HRQOL）和成本效益部分，将能够从患者的角度评估各种结果的相对重要性，理解干预策略的负担与益处之间的平衡，并提供有关依从性的宝贵见解。所使用的HRQOL测量方法包括糖尿病症状困扰清单；36项简短健康调查问卷第2版（SF-36）（兰德公司，加利福尼亚州圣莫尼卡）；患者健康问卷（PHQ）抑郁测量量表（辉瑞公司，纽约州纽约）；世界卫生组织（WHO）糖尿病治疗满意度问卷（DTSQ）；以及欧洲生活质量感受温度计（欧洲生活质量小组，荷兰鹿特丹）。ACCORD试验中的成本效益分析（CEA）将提供有关试验中所比较的不同干预措施相对经济效率的信息。有效性将通过获得的无心血管事件年数和获得的质量调整生命年数来衡量（使用健康效用指数第3版[HUI-3][健康效用公司，加拿大安大略省邓达斯]来衡量健康状态效用）。成本将是从单一支付者医疗系统的角度评估的直接医疗成本，通过患者和诊所成本表格以及医院出院总结来收集。主要的HRQOL和CEA假设与主要的ACCORD试验中的假设一致，分别探讨了ACCORD的3种主要干预措施的效果。也有不假设治疗对HRQOL影响具有独立性的次要（成对参考案例）比较。CEA将在4311名ACCORD参与者的子样本上进行，HRQOL将在CEA子样本中的2053名参与者的子样本上进行。大多数评估将通过在基线以及12、36和48个月时进行问卷调查来完成。
