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A randomised controlled trial of the effects of a web-based PSA decision aid, Prosdex. Protocol

机译:基于网络的PSA决策辅助工具Prosdex的效果的随机对照试验。协议

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Background Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing. The aim of this study is to evaluate the effect of a web-based PSA decision-aid, Prosdex, on informed decision making in men. The objective is to assess the effect of Prosdex on six specific outcomes: (i) knowledge of PSA and prostate cancer-related issues – the principal outcome of the study; (ii) attitudes to testing; (iii) decision conflict; (iv) anxiety; (v) intention to undergo PSA testing; (vi) uptake of PSA testing. In addition, a mathematical simulation model of the effects of Prosdex will be developed. Methods A randomised controlled trial with four groups: two intervention groups, one viewing Prosdex and the other receiving a paper version of the site; two control groups, the second controlling for the potential Hawthorn effect of the questionnaire used with the first control group. Men between the ages of 50 and 75, who have not previously had a PSA test, will be recruited from General Practitioners (GPs) in Wales, UK. The principal outcome, knowledge, and four other outcome measures – attitudes to testing, decision conflict, anxiety and intention to undergo testing – will be measured with an online questionnaire, used by men in three of the study groups. Six months later, PSA test uptake will be ascertained from GP records; the online questionnaire will then be repeated. These outcomes, and particularly PSA test uptake, will be used to develop a mathematical simulation model, specifically to consider the impact on health service resources. Trial registration Current Controlled Trial: ISRCTN48473735.
机译:背景技术知情决策是英国针对前列腺癌检测中前列腺特异性抗原(PSA)检测的男性决策的理论基础。这项研究的目的是评估基于网络的PSA决策辅助工具Prosdex对男性知情决策的影响。目的是评估Prosdex对六个特定结果的影响:(i)对PSA和前列腺癌相关问题的了解–研究的主要结果; (ii)对测试的态度; (iii)决策冲突; (iv)焦虑; (v)有意进行PSA测试; (vi)接受PSA测试。此外,还将开发Prosdex效果的数学仿真模型。方法随机对照试验分为四组:两个干预组,一个观察Prosdex,另一个观察该站点的纸质版本;两个对照组,第二个对照组与第一个对照组一起使用问卷的潜在山楂效应。年龄在50至75岁之间的人以前没有进行过PSA测试,他们将从英国威尔士的全科医生中招募。主要结果,知识和其他四个结果度量(对测试的态度,决策冲突,焦虑和接受测试的意愿)将通过在线问卷进行测量,该问卷由三个研究组的男性使用。六个月后,将从GP记录中确定PSA测试的使用情况;然后将重复在线问卷。这些结果,尤其是PSA测试的采用,将用于建立数学模拟模型,特别是考虑对卫生服务资源的影响。试用注册当前控制的试用:ISRCTN48473735。

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