NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
BMJ Open. 2020 Nov 5;10(11):e037857. doi: 10.1136/bmjopen-2020-037857.
In the new era of effective systemic therapies for advanced melanoma, early detection of lower volume recurrent disease using surveillance imaging can improve survival. However, intensive imaging follow-up strategies are likely to increase costs to health systems and may pose risks to patients. The objective of this study is to estimate from the Australian health system perspective the cost-effectiveness of four follow-up strategies in resected stage III melanoma over a 5-year period following surgical treatment with curative intent.
A decision-analytic model will be built to estimate the costs and benefits of (1) 12 monthly, (2) 6 monthly, (3) 3-4 monthly positron emission tomography/CT imaging for 5 years, compared with (4) no imaging follow-up. The model will be populated with probabilities of disease recurrence, test performance measures using data from >1000 consecutive resected stage III melanoma patients from Melanoma Institute Australia diagnosed between 2000 and 2017. Healthcare resource use, including surveillance imaging, doctor's visits, subsequent tests and procedures to investigate suspicious findings, will be quantified from detailed patient records and valued using Australian reference pricing. Economic outcomes include cost per new distant melanoma recurrence detected and cost per diagnostic error avoided, for no imaging compared with the other strategies.Deterministic sensitivity analyses will examine the robustness of model results.
This study was approved by the Sydney Local Health District, Sydney Local Health District Ethics Review Committee (RPAH Zone), AU/1/830638 and the Australian Institute of Health and Welfare (EO2019-1-454). The results of this study will be published in peer-reviewed medical and health economics journals and will inform melanoma management guidelines.
在晚期黑色素瘤有效全身治疗的新时代，使用监测成像术早期检测低体积复发性疾病可以提高生存率。然而，密集的影像学随访策略可能会增加卫生系统的成本，并可能给患者带来风险。本研究旨在从澳大利亚卫生系统的角度，评估在根治性手术治疗后 5 年内，对切除的 III 期黑色素瘤患者进行四种随访策略的成本效益。
将建立一个决策分析模型，以估计（1）每月 12 次、（2）每 6 个月、（3）每 3-4 个月进行 5 年正电子发射断层扫描/CT 成像与（4）不进行影像学随访的成本和效益。该模型将使用澳大利亚黑色素瘤研究所 2000 年至 2017 年间诊断的 1000 多例连续切除的 III 期黑色素瘤患者的数据，来确定疾病复发的概率和测试性能指标。医疗资源的使用，包括监测成像、医生就诊、对可疑发现进行后续检查和治疗，将从详细的患者记录中量化，并使用澳大利亚参考定价进行评估。经济结果包括与其他策略相比，不进行影像学随访时每发现一个新的远处黑色素瘤复发的成本和每避免一个诊断错误的成本。确定性敏感性分析将检查模型结果的稳健性。
这项研究得到了悉尼地方卫生区、悉尼地方卫生区伦理审查委员会（RPAH 区）、AU/1/830638 和澳大利亚卫生福利研究所的批准（EO2019-1-454）。这项研究的结果将发表在同行评议的医学和卫生经济学期刊上，并将为黑色素瘤管理指南提供信息。
