Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Department of Sociology, University of Cambridge, Cambridge, United Kingdom.
PLoS One. 2023 Apr 27;18(4):e0285122. doi: 10.1371/journal.pone.0285122. eCollection 2023.
Decision impact studies have become increasingly prevalent in genomic medicine, particularly in cancer research. Such studies are designed to provide evidence of clinical utility for genomic tests by evaluating their impact on clinical decision-making. This paper offers insights into understanding of the origins and intentions of these studies through an analysis of the actors and institutions responsible for the production of this new type of evidence.
We conducted bibliometric and funding analyses of decision impact studies in genomic medicine research. We searched databases from inception to June 2022. The datasets used were primarily from Web of Science. Biblioshiny, additional R-based applications, and Microsoft Excel were used for publication, co-authorship and co-word analyses.
163 publications were included for the bibliometric analysis; a subset of 125 studies were included for the funding analysis. Included publications started in 2010 and increased steadily over time. Decision impact studies were primarily produced for proprietary genomic assays for use in cancer care. The author and affiliate analyses reveal that these studies were produced by 'invisible colleges' of researchers and industry actors with collaborations focused on producing evidence for proprietary assays. Most authors had an industry affiliation, and the majority of studies were funded by industry. While studies were conducted in 22 countries, the majority had at least one author from the USA.
This study is a critical step in understanding the role of industry in the production of new types of research. Based on the data collected, we conclude that decision impact studies are industry-conceived and -produced evidence. The findings of this study demonstrate the depth of industry involvement and highlight a need for further research into the use of these studies in decision-making for coverage and reimbursement.
决策影响研究在基因组医学中越来越普遍，尤其是在癌症研究中。这些研究旨在通过评估基因组测试对临床决策的影响，为其临床实用性提供证据。本文通过分析负责生成这种新型证据的参与者和机构，深入了解这些研究的起源和意图。
我们对基因组医学研究中的决策影响研究进行了文献计量和资金分析。我们从开始到 2022 年 6 月在数据库中进行了搜索。主要数据集来自 Web of Science。使用 Biblioshiny、其他基于 R 的应用程序和 Microsoft Excel 进行了出版物、合著者和共词分析。
纳入文献计量分析的出版物有 163 篇；纳入资金分析的出版物中有 125 篇。纳入的出版物始于 2010 年，且随着时间的推移稳步增加。决策影响研究主要是为用于癌症护理的专有基因组检测而进行的。作者和附属机构分析表明，这些研究是由研究人员和行业参与者的“无形学院”共同完成的，合作重点是为专有检测生成证据。大多数作者都有行业背景，而且大多数研究都是由行业资助的。虽然这些研究在 22 个国家进行，但大多数研究都至少有一位来自美国的作者。
这项研究是了解行业在生成新型研究中的作用的重要一步。基于收集的数据，我们得出结论，决策影响研究是行业构思和生成的证据。这项研究的结果表明了行业参与的深度，并强调了需要进一步研究这些研究在覆盖范围和报销决策中的应用。
