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
10.3969/j.issn.1673-9701.2024.27.018
- VernacularTitle: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
- Author:
Shaoxiong ZHANG
1
;
Jun LU
;
Congcong YU
;
Lingzhi WU
Author Information
1. 嘉兴市第一医院临床试验机构办公室,浙江嘉兴 314000
- Keywords:
Adherence;
New drug clinical trials;
Social psychology;
Optimization strategies
- From:
China Modern Doctor
2024;62(27):79-83
- CountryChina
- Language:Chinese
-
Abstract:
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.
