基于INTERACT3的神经外科医生对研究者发起的临床研究偏好的现况调查

An INTERACT3-based survey of neurosurgeons’preferences for investigator-initiated trails

目的了解国内INTERACT3参与单位神经外科医生参与研究者发起的临床研究(investigatorinitiated trails,IIT)项目的现状,以及对IIT项目的设计偏好,为以后设计及组织多中心临床研究提供依据。方法2023年9月—10月选择国内参INTERACT3项目的89家参研单位的不同年资及职称的神经外科医生。采用问卷星方式进行问卷调查。结果共回收有效问卷56份,来自29家单位。在56位医生中,52名(92.86%)来自教学医院;45名(80.36%)来自三级甲等医院;30名医生(53.57%)曾经有过主持各类临床研究的经验;55名医生(98.21%)有过参与各类临床研究的经验。主持或参加临床研究的主要目的集中在“积累相关经验,为以后自己牵头项目做准备”(89.29%)和“规范临床诊治”(83.93%)。关于病例报告表的填写方式,受访者更倾向于使用电子数据采集系统(83.93%)。结论受访的神经外科医生主持或参加临床研究的目的主要是辅助临床及科研工作,经济原因对于是否参与临床研究的影响很小;方案设计的合理性和易操作性是吸引受访者参与临床研究的关键,报酬高低对受访者的决策影响不大;临床研究的安全性及受试者入组难度,是阻碍受访者参与临床研究的关键因素。

Objective To understand the current status of the preferences and opinions on the investigatorinitiated trails(IIT)of the neurosurgeons participating in INTERACT3 in China,as well as the design preference for IIT projects,and to provide a basis for the design and organization of multi-center clinical studies in the future.Methods Neurosurgeons with different seniority and professional titles from 89 domestic research institutions participating in the INTERACT3 project were collected from September to October 2023.The questionnaires were collected by questionnaire star.Results A total of 56 valid questionnaires were collected from 29 units.Among the 56 respondents,52 neurosurgeons(92.86%)were from teaching hospitals and 45(80.36%)were from grade A tertiary hospitals.30 neurosurgeons(53.57%)had experience in conducting various clinical studies,and 55 neurosurgeons(98.21%)had experience in participating in various clinical studies.The main purposes of presiding over or participating in clinical research focused on“accumulating relevant experience and preparing for future projects”and“standardizing clinical diagnosis and treatment”,which were 89.29%and 83.93%.Respectively,regarding the way the case report form completing,respondents preferred to use electronic data collection systems(83.93%).Conclusions The purpose of the neurosurgeons interviewed to host or participate in clinical research is mainly to assist clinical and scientific research.Economic reasons have little impact on whether to participate in clinical research.The rationality and ease of operation of the trail design are the keys to attracting respondents to participate in clinical researches, and the level of remuneration haslittle impact on the decision-making of the respondents. The safety of clinical studies and the difficulty of enrollingsubjects are the key factors that hinder respondents’ participation in clinical studies.