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Towards early and broad evaluation of innovative surgical devices: integrating evidence synthesis, stakeholder involvement, and health economic modeling into the clinical research stages of the IDEAL framework.

作者信息

Scholte Mirre, Woudstra Kas, Grutters Janneke P C, Hannink Gerjon, Tummers Marcia, Reuzel Rob P B, Rovers Maroeska M

机构信息

Operating Rooms, Radboud Institute of Health Sciences, Radboudumc, Nijmegen, The Netherlands.

Operating Rooms and Health Evidence, Radboud Institute of Health Sciences, Radboudumc, Nijmegen, Netherlands.

出版信息

BMJ Surg Interv Health Technol. 2022 Sep 2;4(1):e000153. doi: 10.1136/bmjsit-2022-000153. eCollection 2022.

DOI:10.1136/bmjsit-2022-000153
PMID:36110424
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9442474/
Abstract
摘要

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Methods for Early Assessment of the Societal Value of Health Technologies: A Scoping Review and Proposal for Classification.健康技术的社会价值早期评估方法：范围综述与分类建议。
Value Health. 2022 Jul;25(7):1227-1234. doi: 10.1016/j.jval.2021.12.003. Epub 2022 Feb 12.
2
Selecting esophageal cancer patients for lymphadenectomy after neoadjuvant chemoradiotherapy: a modeling study.新辅助放化疗后选择食管癌患者进行淋巴结清扫术：一项建模研究。
BMJ Surg Interv Health Technol. 2020 May 15;2(1):e000027. doi: 10.1136/bmjsit-2019-000027. eCollection 2020.
3
Extent and consequences of lymphadenectomy in oesophageal cancer surgery: case vignette survey.
食管癌手术中淋巴结清扫的范围及后果：病例 vignette 调查
BMJ Surg Interv Health Technol. 2020 Apr 2;2(1):e000026. doi: 10.1136/bmjsit-2019-000026. eCollection 2020.
4
Hand in hand: A multistakeholder approach for co-production of surgical care.携手共进：一种多方利益相关者共同参与手术护理生产的方法。
Am J Surg. 2022 Jan;223(1):214-215. doi: 10.1016/j.amjsurg.2021.07.053. Epub 2021 Aug 8.
5
Beyond the RCT: When are Randomized Trials Unnecessary for New Therapeutic Devices, and What Should We Do Instead?超越 RCT：何时新治疗设备的随机对照试验不再必要，我们应该怎么做？
Ann Surg. 2022 Feb 1;275(2):324-331. doi: 10.1097/SLA.0000000000005053.
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IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.IDEAL-D 框架用于医疗器械创新：临床前阶段的共识声明。
Ann Surg. 2022 Jan 1;275(1):73-79. doi: 10.1097/SLA.0000000000004907.
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