医学临床研究论文质量评价指标体系构建

【目的】 构建医学临床研究论文质量评价指标体系,为医学期刊编辑部/审稿人提供详细的审稿标准以控制我国医学期刊的整体学术质量。【方法】 采用文献研究、专家访谈、实证研究和小组讨论等方法,募集、筛选医学临床研究论文质量评价指标,并根据结构维度归类。【结果】 初步构建出医学临床研究论文质量评价指标体系,该指标体系包含具备伦理委员会审查同意批件、试验性研究受试者须签署知情同意书、具备伦理审查申报书、利益冲突声明、研究真实、报告真实、与临床实践的相关性、被二次研究及转化研究等证据(文献)引用、临床研究注册、报告规范、研究设计方案正确、方法学质量、偏倚风险评估、统计学信息完备且统计结果解读正确、基于学科领域的科学问题创新、证据质量等级的提升、方法学创新17项具体评价指标,分为伦理、真实性、实用性、透明性、科学性、创新性6个维度。对每一项评价指标进行术语定义与解读,解释评价方法并明确评审责任人。【结论】 “真实地接近真值”是临床研究论文质量评价的核心。为有效控制我国医学期刊的整体学术质量,应大力推行标准化审稿、提升医学科学编辑的专业能力、建立并运行医学科学编辑资质认证机制。

Establishment of quality evaluation index system for clinical medical research papers

Purposes] This paper aims to provide medical journal editorial offices/reviewers with detailed review criteria to control the overall academic quality of Chinese medical journals by establishing a quality evaluation index system for clinical medical research papers. Methods] Literature research, expert interview, empirical study, group discussion, and other research methods were used to collect and screen out the quality evaluation indexes of clinical medical research papers. Indexes were categorized according to structural dimensions. Findings] A quality evaluation index system for clinical medical research papers is preliminarily established, including 17 indexes, namely, ethics committee review and consent approval document, the subject's informed consent signature, the ethics review declaration, the conflict of interest statement, the authenticity of the research, the authenticity of report, the correlation with clinical practice, citation of evidence (literature) such as secondary research and transformation research, registration of clinical studies, reporting standards, correct research design, methodological quality, risk of bias assessment, complete statistical information and correct interpretation of statistical results, innovation of scientific issues based on subject areas, improvement of evidence quality levels, and methodological innovations. The system is divided into 6 dimensions (ethics, authenticity, practicality, transparency, scientificity, and innovation). Each evaluation index is defined and interpreted, the evaluation method is explained, and the person responsible for the review is clarified. Conclusions] "Approaching the truth value with proper authentic method" is the core of academic quality evaluation of clinical medical research papers. To effectively control the overall academic quality of medical journals in China, we should promote standardized review process vigorously, improve the professional competence of medical science editors, and establish a certification mechanism for medical science editors.