Purpose: This study aimed to develop a decision-support tool to quantitatively determine authorship in clinical trial publications.Methods: The tool was developed in three phases: consolidation of authorship recommendations from the Good Publication Practice (GPP) and International Committee of Medical Journal Editors (ICMJE) guidelines, identifying and scoring attributes using a 5-point Likert scale or a dichotomous scale, and soliciting feedback from editors and researchers.Results: The authorship criteria stipulated by the ICMJE and GPP recommendations were categorized into 2 Modules. Criterion 1 and the related GPP recommendations formed Module 1 (sub-criteria: contribution to design, data generation, and interpretation), while Module 2 was based on criteria 2 to 4 and the related GPP recommendations (sub-criteria: contribution to manuscript preparation and approval). The two modules with relevant sub-criteria were then differentiated into attributes (n = 17 in Module 1, n = 12 in Module 2). An individual contributor can be scored for each sub-criterion by summing the related attribute values; the sum of sub-criteria scores constituted the module score (Module 1 score: 70 [contribution to conception or design of the study, 20; data acquisition, 7; data analysis, 27; interpretation of data, 16]; Module 2 score: 50 [content development, 27; content review, 18; accountability, 5]). The concept was integrated into Microsoft Excel with adequate formulae and macros. A threshold of 50% for each sub-criterion and each module, with an overall score of 65%, is predefined as qualifying for authorship.Conclusion: This authorship decision-support tool would be helpful for clinical trial sponsors to assess and provide authorship to deserving contributors.

中文翻译：

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开发决策支持工具以量化临床试验出版物中的作者贡献

目的：本研究旨在开发一种决策支持工具，以定量确定临床试验出版物中的作者身份。方法：该工具分三个阶段开发：整合来自良好出版规范 (GPP) 和国际医学期刊编辑委员会的作者身份建议(ICMJE) 指南，使用 5 点李克特量表或二分量表识别和评分属性，并征求编辑和研究人员的反馈。结果：ICMJE 和 GPP 建议规定的作者身份标准分为 2 个模块。标准 1 和相关 GPP 建议形成了模块 1（子标准：对设计、数据生成和解释的贡献），而模块 2 基于标准 2 至 4 和相关 GPP 建议（子标准：对稿件准备和批准的贡献）。然后将具有相关子标准的两个模块区分为属性（模块 1 中的 n = 17，模块 2 中的 n = 12）。通过对相关属性值求和，可以为每个子标准对单个贡献者进行评分；子标准得分的总和构成模块得分（模块 1 得分：70 [对研究概念或设计的贡献，20；数据采集，7；数据分析，27；数据解释，16]；模块 2 得分： 50 [内容开发，27；内容审查，18；问责制，5]）。该概念已通过适当的公式和宏集成到 Microsoft Excel 中。每个子标准和每个模块的阈值为 50%，总分为 65%，被预定义为符合作者资格。结论：