Development and application of a real-world-data-based indicator system to evaluate the use of diagnostic large medical equipment_Chinese Journal of Evidence-Based Medicine

Authors：

XIONG Yihao ¹ , MA Yu ^2,3,4 , HE Tao ⁵ , YANG Fuzhou ⁶ , HE Xingming ⁷ , CUI Futao ¹ , WANG Hui ⁵ , LIU Yemei ⁶ , LU Wanjun ⁷ , TIAN Rong ¹ , LI Ling ^2,3,4 ,  SUN Xin ^2,3,4 ,  LI Qianrui ^1,2,3,4

1. Department of Nuclear Medicine, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Haikou 570100, P. R. China;
4. Sichuan Center of Technology Innovation for Real World Data, Chengdu 610041, P. R. China;
5. Department of Nuclear Medicine, Panzhihua Central Hospital, Panzhihua 617000, P. R. China;
6. Department of Nuclear Medicine, Ya’an People’s Hospital, Ya’an 625000, P. R. China;
7. Department of Nuclear Medicine, Guangyuan Central Hospital, Guangyuan 628000, P. R. China;

Corresponding author：

SUN Xin, Email: sunxin@wchscu.cn; LI Qianrui, Email: liqianrui@wchscu.cn

Keywords：

Large medical equipment; Comprehensive evaluation; Indicator system; Analytic hierarchy process; Real-word data

DOI：

10.7507/1672-2531.202504186

Video：

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Objectives To develop a real-world-data-based monitoring system for diagnostic large medical equipment, and to use PET/CT as a carrier for validation. Methods We used literature survey, site investigation, and two-rounds of modified Delphi methods to develop the indicator system, and used the analytic hierarchy process method to determine the weight of each indicator. We collected real-world PET/CT data from four tertiary hospitals from July to December 2022, and monitored the use of PET/CT in each hospital. Results Questionnaire recovery rates of 2 rounds were 100% and 88%, respectively, the expert authority coefficient was greater than 0.70, and the coordination coefficients of experts in the total index were 0.307 and 0.471 (P<0.001). A three-level indicator system was established to monitor the use of large medical equipment, with three first-level indicators (clinical use, implementation, and other efficiencies), eight second-level indicators, and 15 third-level indicators. Empirical experiment found different hospitals vary in efficiency (of clinical use), staff status, and economic and research efficiency, while remained similar in other indicators. Conclusion We developed a monitoring system for diagnostic large medical equipment based on real-world data, and used PET/CT as a carrier for validation. These findings provided theoretical and empirical foundations for the management of diagnostic large medical equipment in China.

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1. 国家卫生健康委员会. 关于发布大型医用设备配置许可管理目录的通知(2018年).
2. 杨光, 杨丽亚, 董蓬玉, 等. 我国公立医院住院病人医药费用分析. 中国公共卫生管理, 2020, 36(1): 24-27.
3. 梁斐, 胡献之, 刘佳琦, 等. 2005年和2009年全国CT、MRI检查总费用估算与分析. 中国卫生资源, 2012, 15(6): 462-464.
4. 陈英耀, 董恒进, 刘佳琦, 等. 我国乙类大型医用设备配置、利用现状与政策建议. 中国卫生资源, 2012, 15(1): 42-45.
5. 段胜楠, 吴媛, 梁斐, 等. 大型医用设备使用合理性分析. 中国卫生资源, 2012, 15(3): 228-230.
6. 刘佳琦, 陈英耀. 三种大型医用设备使用适宜性评价及分析. 中国卫生政策研究, 2013, 6(2): 40-43.
7. Huang B, Law MW, Khong PL. Whole-body PET/CT scanning: estimation of radiation dose and cancer risk. Radiology, 2009, 251(1): 166-174.
8. Brix G, Lechel U, Glatting G, et al. Radiation exposure of patients undergoing whole-body dual-modality 18F-FDG PET/CT examinations. J Nucl Med, 2005, 46(4): 608-613.
9. 卫生部办公厅. 卫生部办公厅关于规范健康体检应用放射检查技术的通知.
10. Framework for FDA's real world evidence program.
11. 吴博生, 陈英耀, 耿劲松, 等. 大型医用设备配置规划与配置许可证制度的政策评价. 中国医院管理, 2016, 36(1): 25-27.
12. 张宇斐, 柴建军, 胡冰水, 等. 基于德尔菲法和层次分析法的现代医院门诊医疗质控指标体系构建与应用. 中国医院, 2021, 25(3): 36-39.
13. Hasson F, Keeney S, Mckenna H. Research guidelines for the Delphi survey technique. J Adv Nurs, 2008, 32(4): 1008-1015.
14. 曾光. 现代流行病学. 北京: 气象出版社, 2002.
15. 陶文娟, 文进, 严玲, 等. 基于分级诊疗的患者信任度评价指标体系的构建. 中国循证医学杂志, 2018, 18(8): 802-806.
16. Ijzerman MJ, van Til JA, Bridges JF. A comparison of analytic hierarchy process and conjoint analysis methods in assessing treatment alternatives for stroke rehabilitation. Patient, 2012, 5(1): 45-56.
17. Diaz-Ledezma C, Parvizi J. Surgical approaches for cam femoroacetabular impingement: the use of multicriteria decision analysis. Clin Orthop Relat Res, 2013, 471(8): 2509-2516.
18. 马玉, 惠文, 邓可, 等. 缺血性脑卒中中成药综合评价指标体系构建研究. 中国循证医学杂志, 2022, 22(9): 1055-1061.
19. 孙欣然, 孙金海. 运用德尔菲法和层次分析法构建基于基本能力和基本状态的养老照护评估指标体系. 实用心脑肺血管病杂志, 2018, 26(2): 58-62.
20. 董君. 层次分析法权重计算方法分析及其应用研究. 科技资讯, 2015, 13(29): 218, 20.
21. 邓雪, 李家铭, 曾浩健, 等. 层次分析法权重计算方法分析及其应用研究. 数学的实践与认识, 2012, 42(7): 93-100.
22. 孙振球, 徐勇勇. 医学统计学. 北京: 人民卫生出版社, 2014.
23. 关于发布2018-2020年大型医用设备配置规划的通知.
24. Moriarity AK, Klochko C, O'Brien M, et al. The effect of clinical decision support for advanced inpatient imaging. J Am Coll Radiol, 2015, 12(4): 358-363.
25. Tapper EB, Sengupta N, Lai M, et al. A decision support tool to reduce overtesting for ceruloplasmin and improve adherence with clinical guidelines. JAMA Intern Med, 2015, 175(9): 1561-1562.
26. Comprehensive clinical audits of diagnostic radiology practices: a tool for quality improvement. Vienna: International Atomic Energy Agency, 2010.
27. European Society of Radiology (ESR). The ESR Audit Tool (Esperanto): genesis, contents and pilot. Insights Imaging, 2018, 9(6): 899-903.
28. 杨玉洁, 毛阿燕, 邱五七, 等. 医疗机构大型医用设备使用管理评价指标体系构建. 中国医院管理, 2022, 42(4): 26-30.
29. 卫生部. 卫生部关于印发《2011-2015年全国正电子发射型断层扫描仪配置规划》的通知.
30. 国家卫生健康委三级公立医院绩效考核工作领导小组. 国家三级公立医院绩效考核操作手册(2020版).

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