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Clinical Impact of the Predict Prostate Risk Communication Tool in Men Newly Diagnosed with Nonmetastatic Prostate Cancer: A Multicentre Randomised Controlled Trial
European Urology ( IF 25.3 ) Pub Date : 2021-09-04 , DOI: 10.1016/j.eururo.2021.08.001
David Thurtle 1 , Val Jenkins 2 , Alex Freeman 3 , Mike Pearson 3 , Gabriel Recchia 3 , Priya Tamer 4 , Kelly Leonard 4 , Paul Pharoah 5 , Jonathan Aning 6 , Sanjeev Madaan 7 , Chee Goh 8 , Serena Hilman 9 , Stuart McCracken 10 , Petre Cristian Ilie 11 , Henry Lazarowicz 12 , Vincent Gnanapragasam 1
Affiliation  

Background

Predict Prostate is a freely available online personalised risk communication tool for men with nonmetastatic prostate cancer. Its accuracy has been assessed in multiple validation studies, but its clinical impact among patients has not hitherto been assessed.

Objective

To assess the impact of the tool on patient decision-making and disease perception.

Design, setting, and participants

A multicentre randomised controlled trial was performed across eight UK centres among newly diagnosed men considering either active surveillance or radical treatment. A total of 145 patients were included between 2018 and 2020, with median age 67 yr (interquartile range [IQR] 61–72) and prostate-specific antigen 6.8 ng/ml (IQR 5.1–8.8).

Intervention

Participants were randomised to either standard of care (SOC) information or SOC and a structured presentation of the Predict Prostate tool.

Outcome measurements and statistical analysis

Validated questionnaires were completed by assessing the impact of the tool on decisional conflict, uncertainty, anxiety, and perception of survival.

Results and limitations

Mean Decisional Conflict Scale scores were 26% lower in the Predict Prostate group (mean = 16.1) than in the SOC group (mean = 21.7; p = 0.027). Scores on the “support”, “uncertainty”, and “value clarity” subscales all favoured Predict Prostate (all p < 0.05). There was no significant difference in anxiety scores or final treatment selection between the two groups. Patient perception of 15-yr prostate cancer–specific mortality (PCSM) and overall survival benefit from radical treatment were considerably lower and more accurate among men in the Predict Prostate group (p < 0.001). In total, 57% of men reported that the Predict Prostate estimates for PCSM were lower than expected, and 36% reported being less likely to select radical treatment. Over 90% of patients in the intervention group found it useful and 94% would recommend it to others.

Conclusions

Predict Prostate reduces decisional conflict and uncertainty, and shifts patient perception around prognosis to be more realistic. This randomised trial demonstrates that Predict Prostate can directly inform the complex decision-making process in prostate cancer and is felt to be useful by patients. Future larger trials are warranted to test its impact upon final treatment decisions.

Patient summary

In this national study, we assessed the impact of an individualised risk communication tool, called Predict Prostate, on patient decision-making after a diagnosis of localised prostate cancer. Men were randomly assigned to two groups, which received either standard counselling and information, or this in addition to a structured presentation of the Predict Prostate tool. Men who saw the tool were less conflicted and uncertain in their decision-making, and recommended the tool highly. Those who saw the tool had more realistic perception about their long-term survival and the potential impact of treatment upon this.

Take Home Message

The use of an individualised risk communication tool, such as Predict Prostate, reduces patient decisional conflict and uncertainty when deciding about treatment for nonmetastatic prostate cancer. The tool leads to more realistic perceptions about survival outcomes and prognosis.



中文翻译:

预测前列腺风险沟通工具对新诊断为非转移性前列腺癌男性的临床影响:一项多中心随机对照试验

背景

Predict Prostate是一种免费的在线个性化风险沟通工具,适用于患有非转移性前列腺癌的男性。其准确性已在多项验证研究中进行了评估,但迄今为止尚未评估其对患者的临床影响。

客观的

评估该工具对患者决策和疾病感知的影响。

设计、设置和参与者

在考虑主动监测或根治性治疗的新诊断男性中,在八个英国中心进行了一项多中心随机对照试验。2018 年至 2020 年间共纳入 145 名患者,中位年龄 67 岁(四分位距 [IQR] 61-72),前列腺特异性抗原 6.8 ng/ml(IQR 5.1-8.8)。

干涉

参与者被随机分配到护理标准 (SOC) 信息或 SOC 以及预测前列腺工具的结构化演示中。

结果测量和统计分析

通过评估该工具对决策冲突、不确定性、焦虑和生存感知的影响来完成验证问卷。

结果和局限性

预测前列腺组的平均决策冲突量表分数(平均值 = 16.1)比 SOC 组(平均值 = 21.7;p  = 0.027)低 26%。“支持”、“不确定性”和“价值明确性”分量表的得分都支持预测前列腺(所有p  < 0.05)。两组的焦虑评分或最终治疗选择无显着差异。在预测前列腺组的男性中,患者对 15 年前列腺癌特异性死亡率 (PCSM) 和根治性治疗带来的总生存期益处的感知显着降低且更准确(p < 0.001)。总体而言,57% 的男性报告 PCSM 的预测前列腺估计值低于预期,36% 的男性报告不太可能选择根治性治疗。干预组中超过 90% 的患者认为它有用,94% 的患者会推荐给其他人。

结论

预测前列腺减少了决策冲突和不确定性,并使患者对预后的看法更加现实。这项随机试验表明,Predict Prostate 可以直接为前列腺癌的复杂决策过程提供信息,并且被患者认为是有用的。未来有必要进行更大规模的试验来测试其对最终治疗决策的影响。

患者总结

在这项全国性研究中,我们评估了一种名为“预测前列腺”的个性化风险沟通工具对诊断出局部前列腺癌后患者决策的影响。男性被随机分配到两组,一组接受标准咨询和信息,或者除了预测前列腺工具的结构化演示之外。看到该工具的男性在决策时不那么矛盾和不确定,并高度推荐该工具。那些看到该工具的人对他们的长期生存以及治疗对此的潜在影响有更现实的看法。

带回家留言

在决定非转移性前列腺癌的治疗时,使用个性化风险沟通工具(如预测前列腺)可减少患者的决策冲突和不确定性。该工具导致对生存结果和预后的更现实的看法。

更新日期:2021-10-15
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