Department of Public Health, History of Science and Gynecology, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.
CIBER of Epidemiology and Public Health, CIBERESP, 28029 Madrid, Spain.
Int J Environ Res Public Health. 2022 Jul 22;19(15):8904. doi: 10.3390/ijerph19158904.
Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients' perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences.
机会性前列腺特异性抗原（PSA）筛查可能降低前列腺癌死亡率风险，但与假阳性结果、活检并发症和过度诊断有关。尽管不同组织强调了共同决策（SDM）在帮助男性决定是否进行前列腺癌筛查方面的重要性，但最近的评估表明，现有的决策辅助工具未能促进 SDM，主要是因为它们在设计中没有考虑患者的观点。我们旨在按照知识转化框架系统地开发和测试一种促进前列腺癌筛查中 SDM 的患者决策辅助工具。
可行性研究：一项定量调查，评估人群和临床医生（泌尿科医生和全科医生）对 PSA 测定得出的益处和风险的了解程度，以及对现有建议的认识程度。焦点小组探讨患者和临床医生在讨论前列腺癌筛查时面临的挑战、决策辅助工具的相关性以及如何最好地将其纳入实践。
患者决策辅助工具的开发：基于这些数据，将开发一种基于证据的多组分 SDM 患者决策辅助工具。
用户测试：通过基于混合方法（问卷和半结构化审查）的用户测试设计，对初始患者决策辅助工具原型进行评估。通过多次反馈和重新设计迭代周期，对决策辅助工具进行改进。
验证：通过集群随机对照试验评估患者决策辅助工具。设计的患者决策辅助工具将提供有关筛查益处和风险的平衡信息，应帮助患者考虑其个人偏好，并在决策中发挥更积极的作用。设计良好的患者决策辅助工具（PDA）将提供有关筛查益处和风险的平衡信息，并帮助患者考虑其个人偏好。
