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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。

Clinical Impact of the Predict Prostate Risk Communication Tool in Men Newly Diagnosed with Nonmetastatic Prostate Cancer: A Multicentre Randomised Controlled Trial.

机构信息

Department of Surgery, University of Cambridge School of Clinical Medicine, Cambridge, UK.

Brighton and Sussex Medical School, Brighton, UK.

出版信息

Eur Urol. 2021 Nov;80(5):661-669. doi: 10.1016/j.eururo.2021.08.001. Epub 2021 Sep 4.

Abstract

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.

摘要

背景

Predict Prostate 是一款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,但尚未评估其对患者的临床影响。

目的

评估该工具对患者决策和疾病认知的影响。

设计、地点和参与者:在英国 8 个中心的一项多中心随机对照试验中,对考虑主动监测或根治性治疗的新诊断男性进行了评估。2018 年至 2020 年间共纳入 145 例患者,中位年龄 67 岁(四分位距 [IQR] 61-72),前列腺特异性抗原 6.8ng/ml(IQR 5.1-8.8)。

干预措施

参与者被随机分配至标准护理(SOC)信息或 SOC 和 Predict Prostate 工具的结构化介绍。

结局测量和统计分析

通过评估工具对决策冲突、不确定性、焦虑和生存感知的影响,完成了经过验证的问卷。

结果和局限性

Predict Prostate 组的决策冲突量表平均得分降低了 26%(均值=16.1),而 SOC 组的得分(均值=21.7;p=0.027)。“支持”、“不确定性”和“价值明确性”子量表的评分均倾向于 Predict Prostate(均 p<0.05)。两组之间焦虑评分或最终治疗选择无显著差异。Predict Prostate 组男性对 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获益的感知明显更低且更准确(均 p<0.001)。总共 57%的男性报告说,Predict Prostate 对 PCSM 的估计值低于预期,36%的男性报告说不太可能选择根治性治疗。干预组超过 90%的患者认为该工具有用,94%的患者会向他人推荐。

结论

Predict Prostate 降低了决策冲突和不确定性,并使患者对预后的感知更符合实际。这项随机试验表明,Predict Prostate 可以直接影响前列腺癌的复杂决策过程,并且受到患者的好评。需要进一步进行更大规模的试验来检验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 Predict Prostate 的个体化风险沟通工具对局部前列腺癌患者诊断后决策的影响。男性被随机分配至两组,一组接受标准咨询和信息,另一组在接受标准咨询和信息的基础上,还接受了 Predict Prostate 工具的结构化介绍。使用该工具的男性在决策时的冲突和不确定性减少,并且高度推荐该工具。使用该工具的男性对自己的长期生存和治疗对生存的潜在影响的感知更符合实际。

要点

使用 Predict Prostate 等个体化风险沟通工具可降低非转移性前列腺癌患者在治疗决策时的决策冲突和不确定性。该工具使患者对生存结果和预后的感知更符合实际。

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