首页|社会心理因素对新药临床试验初期慢性病受试者依从性的影响及其提升策略剖析

社会心理因素对新药临床试验初期慢性病受试者依从性的影响及其提升策略剖析

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目的 探讨在新药临床试验初期,社会心理因素对慢性病受试者治疗依从性的影响,并提出优化策略.方法 收集并分析2020年12月至2023年12月于嘉兴市第一医院参与新药临床试验慢性病受试者的观察数据,包括社会人口学信息、艾森克人格问卷(Eysenck personality questionnaire,EPQ)调查结果、90 项症状自评量表(symptom checklist 90,SCL-90)评分、贝克焦虑量表(Beck anxiety inventory,BAI)评分、贝克抑郁量表(Beck depression inventory,BDI)评分,并将SCL-90按10个因子维度分类评估得分、EPQ按4个维度标准T分分类评估得分.应用单因素和多因素Logistic对数据进行分析.结果 单因素分析结果显示,性别、外出意愿、EPQ_T神经质、SCL-90、SCL躯体、SCL强迫、SCL人际、SCL抑郁、SCL焦虑、SCL精神病、SCL其他、BAI评分和BDI评分与慢性病受试者的依从性相关.多因素分析结果显示,较强外出意愿、较高的BAI及BDI评分与非依从性风险呈正相关,而SCL-90躯体因子得分的增加与慢性病受试者依从性风险降低有关.结论 在新药临床试验初期识别并管理慢性病受试者的焦虑和抑郁状态,关注外出计划,对提升依从性至关重要.在特定情况下,慢性病受试者对身体的不适感知可反向促进其依从性.
The analysis of the impact of social psychological factors on adherence of subjects with chronic diseases at the initial stage of new drug clinical trials and the enhancement strategies
Objective To investigate the impact of social psychological factors on adherence among subjects with chronic diseases during the early phase of new drug clinical trials and propose strategies to optimize trial outcomes.Methods Between December 2020 to December 2023,observational datas were collected from subjects participating in new drug clinical trials in the Frist Hospital of Jiaxing,including customized sociodemographic informations,Eysenck personality questionnaire(EPQ)survey results,symptom checklist 90(SCL-90)scores,Beck anxiety inventory(BAI)scores,Beck depression inventory(BDI)scores.The SCL-90 was further categorized into ten factor scores,and the EPQ was evaluated based on four dimensional standard T-scores.Univariate and multivariate Logistic regression analyses were conducted to identify the related factors.Results Univariate analyses showed that gender,willingness to go out,EPQ_T neuroticism,SCL-90,SCL somatic,SCL obsessive compulsive,SCL interpersonal,SCL depression,SCL anxiety,SCL psychoticism,SCL other,BAI scores,and BDI scores were associated with adherence in subjects with chronic diseases.Multivariate analysis confirmed that a higher willingness to go out,elevated BAI and BDI scores were positively associated with non-adherence risk,whereas an increase in the SCL-90 somatization factor scores were inversely related to adherence risk in subjects with chronic diseases.Conclusion Identifying and managing anxiety and depression among subjects with chronic diseases,as well as understanding their outdoor plans,are crucial for enhancing adherence during the early stages of new drug clinical trials.In certain instances,subjects with chronic diseases heightened awareness of bodily discomfort may paradoxically promote adherence.

AdherenceNew drug clinical trialsSocial psychologyOptimization strategies

张少雄、卢军、俞聪聪、吴凌智

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嘉兴市第一医院临床试验机构办公室,浙江嘉兴 314000

杭州市萧山区中医院药剂科,浙江杭州 311200

依从性 新药临床试验 社会心理 优化策略

嘉兴市科技计划项目嘉兴市医学重点学科建设项目

2020AD300652023-ZC-008

2024

中国现代医生
中国医学科学院

中国现代医生

影响因子:1.571
ISSN:1673-9701
年,卷(期):2024.62(27)