哥伦比亚2024年纳入p16/Ki-67双重染色检测宫颈病变的成本效益

摘要(中文译文)

为评估在哥伦比亚将p16/Ki-67双染细胞学检查纳入宫颈癌筛查方案相较于标准诊断路径的成本效益，从医疗服务提供者视角构建了决策树模型，采用真实世界数据和科学证据。主要结局指标为避免的有创操作数量。进行了确定性和概率敏感性分析以处理不确定性。纳入p16/Ki-67双染细胞学检查被证明是一种优势策略，可显著减少不必要的阴道镜检查和活检，并产生成本节约（25至29岁女性节约8000万哥伦比亚比索，30至65岁女性节约5400万哥伦比亚比索）。敏感性分析证实了模型的稳健性。该成本效益分析表明，将p16/Ki-67双染检测纳入宫颈癌筛查方案是可取的，因为它减少了不必要的检查并改善了资源配置。需要在当地背景下评估筛查检测性能的研究，并结合发病率和死亡率结局，以在更长时间范围内评估硬终点。

Abstract

To assess the cost-effectiveness of incorporating p16/Ki-67 dual-stain cytology into cervical cancer screening protocols compared to the standard diagnostic pathway in Colombia. A decision-tree model was developed from the healthcare provider perspective, using real-world data and scientific evidence. The primary outcome was the number of invasive procedures avoided. Deterministic and probabilistic sensitivity analyses were performed to address uncertainty. Incorporating p16/Ki-67 dual-stain cytology proved to be a dominant strategy, significantly reducing unnecessary colposcopies and biopsies and generating cost savings (–COP $80 million for women aged 25 to 29 and –COP $54 million for women aged 30 to 65). Sensitivity analyses confirmed model robustness. The cost-effectiveness analysis suggests the advisability of incorporating the p16/Ki-67 dualstaining test into cervical cancer screening protocols, as it reduces unnecessary examinations and improves resource allocation. Studies are needed that evaluate the performance of screening tests in the local context and that incorporate morbidity and mortality outcomes to assess hard outcomes over a longer time horizon.

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