Participant nationality.

Background
Breast cancer prognostic assays are emerging as tools used by physicians in the cancer treatment decision-making process. This technology is new, and we must interrogate the integration of these assays into clinical practice and their effect on prognosis and treatment for both providers and patients. The objective of this study was to explore perspectives on the use and integration of breast cancer prognostic assays in clinical care.
Methods
15 international researcher-physician/scientist key opinion leaders who had conducted studies on breast cancer prognostic assays were interviewed. Participants had conducted studies using five different assays. The interview guide was developed through a literature review and leveraged extensive data collected on key clinical utility outcomes for the assays. All interviews were conducted virtually, recorded, and transcribed verbatim. Data were analysed using thematic analysis.
Results
Three novel themes emerged from participant’s perspectives on the use and value of these assays. The emerging role of prognostic assays to identify overtreatment and unnecessary care was highlighted by the majority of participants. The primary value of these tools is to identify patients who will not benefit from adjuvant chemotherapy. Participants reported that current standard practice is to overtreat and portrayed the binary or definitive results of these assays as an important tool to reduce overtreatment. Participants also provided insights into deliberate efforts to integrate the assays into clinical practice and how improved quality of life and reduction in overtreatment was positioned to justify high cost of the assay. Finally, participants reported how the perspectives and uses of these assays vary significantly in different countries and cultures. This jurisdictional variation in cancer prognosis and treatment was observed as producing uneven and sometimes problematic interpretations of value for the assays.
Conclusions
The results of this study provide insights into the integration of prognostic assays into healthcare services. The assays are seeking to extend the boundaries of their clinical utility through identifying overtreatment and low value care. Efforts to integrate these assays and justify their high prices are unpacked and reveal complex and contradictory factors. Finally, these results illuminate that the varied approaches to cancer treatment, and varied use of chemotherapy create disparate perceptions of value for the assays.

背景
乳腺癌预后检测试剂盒（breast cancer prognostic assays）正逐步成为医师在癌症治疗决策过程中使用的工具。该技术尚属新兴领域，我们亟需探究此类检测试剂盒整合入临床实践的路径，及其对医患双方的预后评估与治疗决策所产生的影响。本研究的核心目标为探究临床诊疗中该类检测试剂盒的应用与整合现状的相关观点。
方法
本研究访谈了15位兼具研究者与医师/科学家身份的国际关键意见领袖（key opinion leaders, KOLs），他们均开展过乳腺癌预后检测试剂盒相关研究。受访对象均曾针对5种不同的此类检测试剂盒开展相关研究。本次访谈指南通过系统文献综述制定，并依托了从此类检测试剂盒的关键临床效用结局中收集的大量数据。所有访谈均以线上形式开展，全程录音并逐字转录。研究采用主题分析法（thematic analysis）对转录数据进行分析。
结果
基于受访对象对该类检测试剂盒的应用与价值的观点，本研究归纳出3个全新的主题。多数受访对象着重强调了此类检测试剂盒在识别过度治疗与非必要诊疗方面的新兴作用。此类工具的核心价值在于识别出无法从辅助化疗（adjuvant chemotherapy）中获益的患者。受访对象指出，当前临床实践普遍存在过度治疗的情况，并认为此类检测试剂盒的二元化或确定性结果是降低过度治疗的重要手段。受访对象还就主动推动此类检测试剂盒整合入临床实践的相关举措，以及如何以提升患者生活质量、减少过度治疗为依据，为该类检测试剂盒的高昂成本提供合理性支撑的路径分享了见解。最后，受访对象提及，不同国家与文化背景下，此类检测试剂盒的应用观点与使用方式存在显著差异。这种不同司法管辖区域内的癌症预后与诊疗模式差异，导致对该类检测试剂盒价值的解读存在不均衡，甚至有时会出现有问题的解读。
结论
本研究结果为该类检测试剂盒整合入医疗服务体系提供了新的见解。此类检测试剂盒正通过识别过度治疗与低价值诊疗，拓展其临床应用边界。推动此类检测试剂盒整合入临床并为其高昂定价提供合理性支撑的相关举措，揭示出诸多复杂且相互矛盾的影响因素。最后，本研究结果表明，癌症诊疗路径的差异化与化疗使用的多样化，导致对该类检测试剂盒价值的认知存在显著分歧。