Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials

ObjectiveTo draft the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials for standardizing thedata collection， storage， transmission， exchange， analysis， and evaluation of traditional Chinese medicine （TCM） studies. In addition to the application of conventional systematic review and meta-analysis， this draft will provide strong support for the development of automated systematic review， facilitate the efficient utilization of TCM clinical evidence， and underpin the evidence-based rapid decision-making in TCM. MethodThis study was structured into three stages. During the first stage （pre-research）， suggestions for formulating new standards were proposed based on comprehensive research and demonstration of views obtained from literature investigation and expert interviews. The second stage concentrated on drafting the standard by assembling a working group and crafting a draft solicitation document for metadata standards. At the third stage， feedback was sought from relevant institutions， organizations， and experts and scholars outside the research group via mail or other means to finalize the draft standard. ResultDuring the pre-research stage， a preliminary examination was conducted to assess the characteristics and current status of clinical research metadata standards， and the information was identified regarding the significance of formulating the standard， principles guiding metadata formulation， reference materials， and suggestions for metadata subset establishment. After establishing a working group and drafting the initial version of the standard， opinions from external experts were sought via email. Based on the comments， a third round of revisions was conducted， resulting in the finalization of a draft for the standard. The finalized version of the standard draft comprised 12 sections： preface， introduction， scope， normative reference documents， terms and abbreviations， principles and composition， metadata description method， metadata summary representation， metadata dictionary description， Extensible Markup Language （XML） markup example， JavaScript Object Notation （JSON） markup example， and references. Of these， the section of metadata summary representation/metadata dictionary description contained 6 metadata subsets， involving 20 metadata entities and 141 metadata elements. ConclusionThrough literature research， expert interviews， questionnaire surveys， standard drafting， and opinion solicitation， this study drafts the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials. This draft plays a crucial role in standardizing TCM clinical research and advancing objective scientific evaluation and effective utilization of TCM.