Borsoi Ludovica, Listorti Elisabetta, Ciani Oriana
Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Milan, Italy.
Pharmacoecon Open. 2024 Nov;8(6):945-959. doi: 10.1007/s41669-024-00519-1. Epub 2024 Sep 12.
Shared decision-making (SDM) plays a crucial role in breast cancer care by empowering patients and reducing decision regret. Patient decision aids (PtDAs) are valuable tools for facilitating SDM, now available in digital and artificial intelligence (AI)-powered formats to offer increasingly personalized contents. The ongoing CINDERELLA clinical trial (ClinicalTrials.gov: NCT05196269) evaluates an innovative AI cloud-based approach using a web platform and a mobile application (CINDERELLA APProach) versus the conventional approach to support SDM in breast cancer patients undergoing locoregional treatment. This protocol outlines a trial-based multidimensional evaluation, encompassing economic, financial, implementability, and environmental considerations associated with the CINDERELLA APProach.
A within-trial cost-consequence and cost-utility analysis from a societal perspective will be performed using patient-level data on outcomes and resource use. The latter will be valued in monetary terms using country-specific unit costs or patient valuations. A budget impact analysis will be performed over 1 and 5 years from the budget holder perspectives. The CINDERELLA APProach implementability will be assessed through an evaluation of its usability, acceptability, organizational impact, and overall feasibility. The environmental impact will be quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data for the evaluation will be gathered from patient questionnaires, interviews with patients and managers, focus groups with healthcare professionals, and app electronic data.
A thorough understanding of the broad consequences of the CINDERELLA APProach may foster its successful translation into real-world settings, hopefully benefiting breast cancer patients and clinical practice.
共同决策（SDM）通过赋予患者权力和减少决策遗憾，在乳腺癌护理中发挥着关键作用。患者决策辅助工具（PtDAs）是促进共同决策的宝贵工具，现在有数字和人工智能（AI）驱动的形式，可提供越来越个性化的内容。正在进行的灰姑娘临床试验（ClinicalTrials.gov：NCT05196269）评估了一种创新的基于AI云的方法，该方法使用网络平台和移动应用程序（灰姑娘方法）与传统方法，以支持接受局部区域治疗的乳腺癌患者进行共同决策。本方案概述了基于试验的多维评估，包括与灰姑娘方法相关的经济、财务、可实施性和环境考虑因素。
将从社会角度进行试验内成本后果和成本效用分析，使用关于结果和资源使用的患者层面数据。后者将使用特定国家的单位成本或患者估值以货币形式进行估值。将从预算持有者的角度进行1年和5年的预算影响分析。灰姑娘方法的可实施性将通过对其可用性、可接受性、组织影响和总体可行性的评估来评估。环境影响将在几个维度上进行定量评估，如数量、适当性和排放，并辅以定性见解。总体而言，评估数据将从患者问卷、患者和管理人员访谈、医疗保健专业人员焦点小组以及应用程序电子数据中收集。
全面了解灰姑娘方法的广泛后果可能有助于其成功转化为实际应用场景，有望使乳腺癌患者和临床实践受益。
