Prostate Center, University Hospital Muenster, Muenster, Germany.
Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany.
Sci Rep. 2021 Dec 6;11(1):23503. doi: 10.1038/s41598-021-02696-z.
International guidelines recommend to inform men about the benefits and harms of prostate specific antigen (PSA) based early detection of prostate cancer. This study investigates the influence of a transactional decision aid (DA) or cost compensation (CC) for a PSA test on the decisional behaviour of men. Prospective, cluster-randomised trial to compare two interventions in a 2 × 2 factorial design: DA versus counselling as usual, and CC versus noCC for PSA-testing. 90 cluster-randomised physicians in the administrative district of Muenster, Germany recruited 962 participants aged 55-69 yrs. in 2018. Primary endpoint: the influence of the DA and CC on the decisional conflict. Secondary endpoints: factors which altered the involvement of the men regarding their decision to take a PSA-test. The primary endpoint was analysed by a multivariate regression model. The choice to take the PSA test was increased by CC and reduced by the DA, the latter also reduced PSA uptake in men who were offered CC. The DA led to an increase of the median knowledge about early detection, changed willingness to perform a PSA test without increasing the level of shared decision, giving participants a stronger feeling of having made the decision by themselves. The DA did not alter the decisional conflict, as it was very low in all study groups. DA reduced and CC increased the PSA uptake. The DA seemed to have a greater impact on the participants than CC, as it led to fewer PSA tests even if CC was granted.Trial registration: German Clinical Trial Register (Deutsches Register Klinischer Studien DRKS00007687). Registered: 06/05/2015. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007687 .
国际指南建议向男性告知基于前列腺特异性抗原（PSA）的前列腺癌早期检测的益处和危害。本研究调查了交易决策辅助（DA）或 PSA 检测费用补偿（CC）对男性决策行为的影响。前瞻性、集群随机试验，在 2×2 析因设计中比较两种干预措施：DA 与常规咨询相比，CC 与 PSA 检测无 CC 相比。德国明斯特行政区的 90 名集群随机医生于 2018 年招募了 962 名 55-69 岁的参与者。主要终点：DA 和 CC 对决策冲突的影响。次要终点：改变男性参与决定进行 PSA 检测的因素。主要终点通过多变量回归模型进行分析。CC 增加了 PSA 检测的选择，DA 减少了 PSA 检测的选择，而后者还减少了提供 CC 的男性进行 PSA 检测的可能性。DA 导致早期检测知识中位数增加，增加了不进行 PSA 检测的意愿，而不会增加共享决策的水平，使参与者更强烈地感到自己做出了决定。DA 并没有改变决策冲突，因为所有研究组的决策冲突都非常低。DA 减少和 CC 增加了 PSA 检测的数量。DA 似乎对参与者的影响大于 CC，因为即使给予 CC，DA 也会导致更少的 PSA 检测。试验注册：德国临床试验注册处（德国临床研究注册 DRKS00007687）。注册：2015 年 6 月 5 日。https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007687。
