Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events
Who volunteers for phase I clinical trials? Influences of anxiety, social anxiety and depressive symptoms on self-selection and the reporting of adverse events
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DOI：
10.1007/s00228-008-0468-8
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发表时间：
2008-06-01
影响因子：
2.9
通讯作者：
Soares-da-Silva, Patricio
中科院分区：
文献类型：
--
作者：
Almeida, Luis;Kashdan, Todd B.;Soares-da-Silva, Patricio
目的探讨焦虑、社交焦虑和抑郁症状对健康受试者自愿参加I期研究和报告不良事件意愿的影响。材料与方法邀请一组从未参加过临床试验的健康受试者（“幼稚受试者”）参加一期研究。对所有受试者进行特质焦虑（状态-特质焦虑量表，STAI-T）、社交焦虑（社交回避和困扰，SAD，和对负面评价的恐惧，FNE）和抑郁症状（贝克抑郁量表，BDI- II）的评估。接受邀请的受试者与拒绝邀请的受试者进行比较。研究了一组“实际参与者”的人格特质，并评估了这些特质与参与过程中报告的不良事件的关系。结果STAI- T评分（R=- 0.203, p< 0.05）、SAD评分（R=- 0.204, p< 0.05）与参与意愿呈显著负相关。拒绝邀请的天真被试在STAI- T （Z=- 2.600, p< 0.01）和SAD （Z=- 2.524, p< 0.05）量表上得分较高。以BDI- II、STAI- T、SAD和FNE作为协变量的Logistic回归也显示，参与的唯一唯一预测因子是STAI- T （p< 0.05）和SAD （p< 0.01）评分。特质焦虑与不良事件报告之间存在显著正相关。结论第一阶段研究的参与者是由低特质焦虑和社交回避行为定义的自我选择样本。这种自我选择偏差可能会影响研究结果，因为焦虑程度较低的受试者倾向于报告较少的不良事件。在第一阶段的研究中，对参与者的性格特征的描述可能很重要。
Objective To investigate the influence of anxiety, social anxiety and depressive symptoms on the willingness of healthy subjects to volunteer for phase I studies and to report adverse events.Materials and methods A group of healthy subjects who had never participated in a clinical trial ("Naive Subjects") were invited to participate in a phase I study. All subjects were assessed for trait anxiety ( State- Trait Anxiety Inventory, STAI-T), social anxiety ( Social Avoidance and Distress, SAD, and Fear of Negative Evaluation, FNE) and depressive symptomatology ( Beck Depression Inventory, BDI- II). Subjects who accepted the invitation to participate were compared with those who refused. The personality traits of a group of " Actual Participants" were examined, and the relation of these traits to adverse events reported during participation was evaluated.Results A significant inverse correlation was found between the STAI- T ( R=- 0.203, p< 0.05) and SAD ( R=- 0.204, p< 0.05) scores and the willingness to participate. Naive Subjects who refused the invitation to participate showed higher scores on STAI- T ( Z=- 2.600, p< 0.01) and SAD ( Z=- 2.524, p< 0.05) inventories. Logistic regression using BDI- II, STAI- T, SAD and FNE as covariates also showed that the only unique predictors of participation were the STAI- T ( p< 0.05) and SAD ( p< 0.01) scores. Significant positive correlations were found between trait anxiety and reporting of adverse events.Conclusion Participants in phase I studies are a self-selected sample defined by low trait- anxiety and social avoidance behaviors. This self- selection bias may affect the study results because less anxious subjects tend to report fewer adverse events. The characterization of a participant's personality traits may be important in phase I studies.