van Tol-Geerdink Julia J, Leer Jan Willem H, Wijburg Carl J, van Oort Inge M, Vergunst Henk, van Lin Emile J, Witjes J Alfred, Stalmeier Peep F M
Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Urology, Rijnstate Hospital, Arnhem, the Netherlands.
Health Expect. 2016 Apr;19(2):459-70. doi: 10.1111/hex.12369. Epub 2015 May 3.
To develop and validate new regret scales and examine whether a decision aid affects different aspects of regret in the treatment choice for prostate cancer.
This was a multicentre trial (three sites) with imbalanced randomization (1 : 2). From 2008 to 2011, patients with localized prostate cancer were randomized 1 : 2 to usual care (N = 77) or usual care plus a decision aid presenting risks and benefits of different treatments (N = 163). The treatments were surgery and (external or interstitial) radiotherapy. Regret was assessed before, and 6 and 12 months after treatment, using the Decisional regret scale by Brehaut et al. (Medical Decision Making, 23, 2003, 281), and three new scales focusing on process, option and outcome regret. The relation between decision aid and regret was analysed by anova.
The concurrent validity of the new regret scales was confirmed by correlations between regret and anxiety, depression, decision evaluation scales and health-related quality of life. With a decision aid, patient participation was increased (P = 0.002), but regret was not. If anything, in patients with serious morbidity the decision aid resulted in a trend to less option regret and less Brehaut regret (P = 0.075 and P = 0.061, with effect sizes of 0.35 and 0.38, respectively). Exploratory analyses suggest that high-risk patients benefitted most from the decision aid.
The new regret scales may be of value in distinguishing separate aspects of regret. In general, regret was not affected by the decision aid. In patients with serious morbidity, a trend to lower option regret with a decision aid was observed.
开发并验证新的遗憾量表，并研究决策辅助工具是否会影响前列腺癌治疗选择中遗憾的不同方面。
这是一项多中心试验（三个地点），采用不均衡随机分组（1:2）。2008年至2011年，将局限性前列腺癌患者按1:2随机分为常规护理组（N = 77）或常规护理加提供不同治疗风险和益处的决策辅助工具组（N = 163）。治疗方法为手术和（外照射或组织间）放疗。使用Brehaut等人的决策遗憾量表（《医学决策》，23，2003，281）以及关注过程、选择和结果遗憾的三个新量表，在治疗前、治疗后6个月和12个月评估遗憾情况。通过方差分析分析决策辅助工具与遗憾之间的关系。
新遗憾量表的同时效度通过遗憾与焦虑、抑郁、决策评估量表以及健康相关生活质量之间的相关性得到证实。使用决策辅助工具后，患者参与度有所提高（P = 0.002），但遗憾程度未改变。如果说有什么不同的话，在有严重并发症的患者中，决策辅助工具导致选择遗憾和Brehaut遗憾有减少的趋势（P = 0.075和P = 0.061，效应量分别为0.35和0.38）。探索性分析表明，高危患者从决策辅助工具中获益最大。
新的遗憾量表可能有助于区分遗憾的不同方面。总体而言，遗憾程度不受决策辅助工具的影响。在有严重并发症的患者中，观察到使用决策辅助工具后选择遗憾有降低的趋势。
