马斯洛需求层次理论对药物早期临床试验受试者依从性的影响

Effect of Maslow's hierarchy of needs theory on the compliance of subjects in early drug clinical trials

目的 分析马斯洛需求层次理论对药物早期临床试验受试者依从性的影响,为提升药物临床试验管理质量提供依据。方法 选取在某三级甲等医院参加药物临床试验的120例健康受试者为研究对象,其中2022年2月至4月为对照组(n=60,实施常规指导),2022年5月至8月为观察组(n=60,采取基于马斯洛需求层次理论的指导)。比较两组受试者对试验相关内容知晓率、回访时间准确率和受试者满意度。结果 观察组受试者对药物知识、膳食规定知晓率均优于对照组(95.00%vs 81.67%,96.67%vs 86.67%,P<0.05),两组受试者对运动要求知晓率比较差异无统计学意义(98.33%vs 88.34%,P>0.05)。与对照组比较,观察组受试者回访时间准确率增高(93.33%vs 80.00%,χ^(2)=6.007,P<0.05),满意度差异无统计学意义(100.00%vs 93.33%,χ^(2)=2.328,P>0.05)。结论 以马斯洛需求层次理论为切入点,分析药物早期临床试验健康受试者的需求,结合临床试验工作特点,满足受试者各层次需求,可提高其依从性,使药物临床试验更加人性化。

Objective To analyze the influence of Maslow's hierarchy of needs theory on the compliance of subjects in early drug clinical trials,in order to provide basis for improving the management quality of drug clinical trial.Methods A total of 120 healthy subjects who participated the drug clinical trial in a level-A tertiary hospital were selected as the study subjects,including the control group from February to April 2022(n=60,adopting routine guidance)and the observation group from May to August 2022(n=60,adopting guidance based on Maslow's hierarchy of needs theory).The awareness rate of the relevant contents of the test,the accuracy rate of the return visit time,and the satisfaction of the subjects were compared between two groups.Results The awareness rates of the subjects in the observation group on drug knowledge and dietary regulations were better than those in the control group(95.00%vs 81.67%,96.67%vs 86.67%,P<0.05),and there was no statistical difference in the awareness rate of exercise requirements between the two groups(98.33%vs 88.34%,P>0.05).Compared with the control group,the accuracy rate of return visit time in the observation group increased(93.33%vs 80.00%,χ^(2)=6.007,P<0.05).There was no statistically significant in satisfaction between the two groups(100.00%vs 93.33%,χ^(2)=2.328,P>0.05).Conclusion Taking Maslow's hierarchy of needs theory as a starting point,analyzing the needs of healthy subjects in early clinical trials,combining with the characteristics of clinical trials and meeting the needs of healthy subjects at all levels,can improve their compliance and make drug clinical trials more humanized.