Tate Charles W, Robertson Alastair D, Zolty Ronald, Shakar Simon F, Lindenfeld Joann, Wolfel Eugene E, Bristow Michael R, Lowes Brian D
Division of Cardiology, University of Colorado Health Sciences Center, Denver, Colorado 80262, USA.
J Card Fail. 2007 Nov;13(9):732-7. doi: 10.1016/j.cardfail.2007.07.001.
Quality of life (QOL) was a prespecified secondary end point in the Beta-Blocker Evaluation of Survival Trial. The Beta-Blocker Evaluation of Survival Trial used four QOL questionnaires to evaluate patient health status over time in response to treatment with placebo or bucindolol. The goal of the current study was to determine the relationship between the different questionnaires, assess the effect of treatment on health status, and evaluate the association between changes in health status and prognosis.
The San Diego Heart Failure (SDHF), Minnesota Living with Heart Failure (MLHF), Patient Global Assessment (PGA), and Physician Global Assessment (PhyGA) questionnaires were measured at baseline through 48 months of follow-up. For SDHF and MLHF, changes from baseline were calculated. Spearman correlation was used to assess relationships, and Cox Proportional Hazards regression was used to predict time to all-cause mortality, and mortality or heart failure hospitalization, bivariately and multivariately. To determine whether beta-blocker treatment affected QOL, the Wilcoxon rank-sum test was used to compare treatment groups.
At 12 months, SDHF (r = +0.56, P = .0001), PGA (r = +0.36, P = .0001), and PhyGA (r = +0.37, P = .0001) correlated with MLHF. SDHF (P = .0001), MLHF (P = .0004), PGA (P = .0001), and PhyGA (P = .0001) were all strongly associated with all-cause mortality, with low values of each associated with a lower hazard. For the combined end point of all-cause mortality or heart failure hospitalization, change in QOL with each instrument had a P value of .0001. At 12 months, bucindolol-treated patients had improvement in both PhyGA and PGA compared with placebo; neither the SDHF nor the MLWF instrument distinguished between the two treatment groups unless a worst-rank assignment was used for patients who died.
The four instruments correlate with each other and predict clinical end points, suggesting that each is a valid measure of health status. According to the PGA and the PhyGA, bucindolol improves QOL.
生活质量（QOL）是生存试验中β受体阻滞剂评估预先设定的次要终点。生存试验中β受体阻滞剂评估使用了四份生活质量问卷，以评估患者在接受安慰剂或布新洛尔治疗后的健康状况随时间的变化。本研究的目的是确定不同问卷之间的关系，评估治疗对健康状况的影响，并评估健康状况变化与预后之间的关联。
在基线至48个月的随访期间，对圣地亚哥心力衰竭（SDHF）、明尼苏达心力衰竭生活（MLHF）、患者整体评估（PGA）和医生整体评估（PhyGA）问卷进行测量。对于SDHF和MLHF，计算相对于基线的变化。使用Spearman相关性评估关系，并使用Cox比例风险回归分别和多变量地预测全因死亡率、死亡率或心力衰竭住院时间。为了确定β受体阻滞剂治疗是否影响生活质量，使用Wilcoxon秩和检验比较治疗组。
在12个月时，SDHF（r = +0.56，P = .0001）、PGA（r = +0.36，P = .0001）和PhyGA（r = +0.37，P = .0001）与MLHF相关。SDHF（P = .0001）、MLHF（P = .0004）、PGA（P = .0001）和PhyGA（P = .0001）均与全因死亡率密切相关，各指标值较低与较低风险相关。对于全因死亡率或心力衰竭住院的联合终点，每种工具的生活质量变化的P值为.0001。在12个月时，与安慰剂相比，接受布新洛尔治疗的患者在PhyGA和PGA方面均有改善；除非对死亡患者使用最差等级赋值，否则SDHF和MLWF工具均无法区分两个治疗组。
这四种工具相互关联并能预测临床终点，表明每种工具都是健康状况的有效衡量指标。根据PGA和PhyGA，布新洛尔可改善生活质量。
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