Abstract
BackgroundInformed 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.MethodsA 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 registrationCurrent Controlled Trial: ISRCTN48473735.
Highlights
Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing
Prosdex is a web-based decision aid to help men consider whether or not to have a Prostate Specific Antigen (PSA) test, potentially for prostate cancer [1]. It was developed in the context of the UK Prostate Cancer Risk Management Programme (PCRMP), a strategy, promoted by the UK National Cancer Screening Programme, which has, as one of its key goals, the promotion of informed decision making about PSA testing [2]
In a systematic review of these trials, we found that knowledge increased by 19.5% and PSA testing decreased by 3.5% [5]
Summary
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. PSA test uptake will be ascertained from GP records; the online questionnaire will be repeated. These outcomes, and PSA test uptake, will be used to develop a mathematical simulation model, to consider the impact on health service resources.
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