Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, IA, United States.
Pain. 2023 Aug 1;164(8):1775-1782. doi: 10.1097/j.pain.0000000000002874. Epub 2023 Mar 6.
Rigorous experimental design with transparent reporting in biomedical science reduces risk of bias and allows for scientists to judge the quality of the research. Basic factors of rigor such as blinding, randomization, power analysis, and inclusion of both sexes impact the reproducibility by reducing experimental bias. We designed a systematic study to analyze basic factors of rigor, inclusion of sex, and whether data were analyzed or disaggregated by sex over the past 10 years in the journal PAIN . Studies that included humans reported randomization in 81%, blinding in 48%, and the use of a power analysis calculation in 27% over the past 10 years. Studies that included mice reported randomization in 35%, blinding in 70%, and the use of a power analysis in 9%. Studies that included rats reported randomization in 38%, blinding in 63%, and the use of power analysis in 12%. This study also found that human studies consistently included both sexes over the past decade, but less than 20% of data were disaggregated or analyzed for sex differences. Although mouse and rat studies predominately used males only, there has been a slight increase in inclusion of both sexes over the past few years. Justification for single-sex studies was below 50% in both human and rodent data. In both human and animal studies, transparency in reporting of experimental design and inclusion of both sexes should be considered standard practice and will result in improved quality and reproducibility of published research.
在生物医学科学中，严格的实验设计和透明的报告可以降低偏差风险，并使科学家能够判断研究的质量。严谨性的基本因素，如盲法、随机化、功效分析以及纳入两性，通过减少实验偏差来提高可重复性。我们设计了一项系统研究，以分析过去 10 年在《疼痛》杂志上发表的研究中严谨性的基本因素、纳入性别以及是否按性别进行数据分析或分解。过去 10 年，包含人类的研究报告中，随机化的比例为 81%，盲法的比例为 48%，使用功效分析计算的比例为 27%。包含小鼠的研究报告中，随机化的比例为 35%，盲法的比例为 70%，使用功效分析的比例为 9%。包含大鼠的研究报告中，随机化的比例为 38%，盲法的比例为 63%，使用功效分析的比例为 12%。本研究还发现，过去十年中，人类研究始终包括两性，但只有不到 20%的数据按性别进行分解或分析。尽管小鼠和大鼠研究主要使用雄性，但近年来纳入两性的比例略有增加。人类和啮齿动物数据中，仅使用单一性别进行研究的理由均低于 50%。在人类和动物研究中，实验设计报告的透明度和纳入两性应被视为标准做法，这将提高已发表研究的质量和可重复性。
