Department of Biomedical Sciences for Health, Università degli Studi di Milano, Via L. Mangiagalli 31, 20133, Milan, Italy.
Radiology Unit, IRCCS Policlinico San Donato, Via Morandi 30, 20097, San Donato Milanese Milan, Italy.
Eur Radiol. 2018 Jun;28(6):2328-2335. doi: 10.1007/s00330-017-5165-5. Epub 2018 Jan 18.
The aims of this paper are to illustrate the trend towards data sharing, i.e. the regulated availability of the original patient-level data obtained during a study, and to discuss the expected advantages (pros) and disadvantages (cons) of data sharing in radiological research. Expected pros include the potential for verification of original results with alternative or supplementary analyses (including estimation of reproducibility), advancement of knowledge by providing new results by testing new hypotheses (not explored by the original authors) on pre-existing databases, larger scale analyses based on individual-patient data, enhanced multidisciplinary cooperation, reduced publication of false studies, improved clinical practice, and reduced cost and time for clinical research. Expected cons are outlined as the risk that the original authors could not exploit the entire potential of the data they obtained, possible failures in patients' privacy protection, technical barriers such as the lack of standard formats, and possible data misinterpretation. Finally, open issues regarding data ownership, the role of individual patients, advocacy groups and funding institutions in decision making about sharing of data and images are discussed.
• Regulated availability of patient-level data of published clinical studies (data-sharing) is expected. • Expected benefits include verification/advancement of knowledge, reduced cost/time of research, clinical improvement. • Potential drawbacks include faults in patients' identity protection and data misinterpretation.
本文旨在阐述数据共享的趋势,即研究过程中原始患者水平数据的有规定条件的可获取性,并讨论放射学研究中数据共享的预期优势(益处)和劣势(弊端)。预期的益处包括通过替代性或补充性分析(包括可重复性的估计)验证原始结果的可能性、通过对已有数据库进行新的假设检验(原作者未探索过的)提供新结果从而推进知识的进步、基于个体患者数据的更大规模分析、促进多学科合作、减少虚假研究的发表、改进临床实践以及降低临床研究的成本和时间。预期的弊端包括原始作者可能无法充分利用其获得的数据的全部潜力、患者隐私保护失败的风险、技术障碍(如缺乏标准格式)以及可能的数据误解。最后,本文还讨论了与数据所有权、个体患者、倡导团体和资助机构在数据和图像共享决策方面的作用相关的尚未解决的问题。
• 有条件地获取已发表临床研究的患者水平数据(数据共享)是预期的。• 预期的益处包括验证/知识进步、降低研究成本/时间、临床改善。• 潜在的弊端包括患者身份保护和数据误解方面的缺陷。