临床试验研究人员对培训的意向及行为分析

摘要

Objective To evaluate the influencing factors of intentionality attitude and behavior of researchers for train-ing in clinical trial with the theory of planned behavior. Methods The questionnaire was designed by Likert in five do-mains, the research contents included behavioral intention, behavioral attitude, perceived behavioral control, subjective norms, behavioral implementation. From April to June 2015, 92 investigators from 10 departments involved in the clini-cal trial of the drug and medical devices in Jiˊnan Military General Hospital were invited to participate in the question-naire survey. The average score of the scale reflected the attitude of the group, >81 points ("not sure" 3 points × 27=81 points) indicated a positive attitude and <81 points tended to be negative. The higher the average score of each point of the scale, the more positive the attitude of the researchers, and scale element less than 3 points may be the factors that affected the active participation of the researchers. Results 91 valid questionnaires were collected, and the rate of return visit was 99%. The average total score of the scale was 83.18 points, which indicated that the study group was neutral. Influencing factors of investigators training with<3 points were environment (attitude of department leaders and other investigators 2.29 points), teaching skills (practicalness 2.37 point, training method 2.32 points), training as-sessment (2.43 points) and time (2.37 points). Conclusion Based on the theory of planned behavior, the attitude and in-fluencing factor in investigators training are evaluated, then targeted intervention (scientific formulation of training plan, optimization of training system, strengthening the awareness of the importance of training ) are made to improve training intention and effect of the researchers.%目的 运用计划行为理论评估研究者对临床试验培训的意向性态度及行为的影响因素.方法采用Likert5级评分法设计调查问卷,调查内容包括报告意向、报告态度、知觉行为控制、主观规范、行为实施五方面.2015年4~6月邀请济南军区总医院药物及医疗器械临床试验的10个专业研究团队成员92人参与问卷调查.量表的平均分反映群体态度,大于81分("说不准"3分×27项=81分)表示态度倾向于积极,小于则倾向于消极.量表各要点的平均得分越高说明研究者所持态度越正性,小于3分的要点可能是影响研究者主动参与培训的制约因素.结果本研究收回有效问卷91份,问卷调查回访率为99%.量表的平均总分为83.18分,表示研究者群体态度中立.影响培训行为实施的因素,即得分低于3分的要素主要有:环境因素(科室及其他研究者对培训的态度2.29分)、培训授课技巧(实践性2.37分、培训方式2.32分)、培训考核(2.43分)以及时间因素(2.37分).结论基于计划行为理论调查出研究者对报告利益冲突的态度以及影响报告的制约因素,机构通过科学制订培训计划、优化机构内部培训体系、强化研究者对培训重要性的认识等干预措施,以期提高研究者的主动培训意向,强化培训效果.