Amira Stephen A, Bressler Brenda L, Lee Jung Hie, Czeisler Charles A, Duffy Jeanne F
Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, USA;
Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, USA.
Clocks Sleep. 2020 Apr 15;2(2):13. doi: 10.3390/clockssleep2020013. eCollection 2020 Jun.
Selecting participants who constitute a representative sample while protecting them from potential adverse outcomes is a concern for clinical researchers. Our research group conducts deep phenotyping studies of the circadian timing system and sleep-wake regulation in long (up to 3 months) laboratory experiments, similar in many ways to "exceptional environment" conditions. Here, we describe the psychological screening process we have used for more than 30 years. We outline our "Select In" and "Select Out" measures within three major categories: psychological, psychophysiological, and psychosocial factors. We describe the screening process, inclusion-exclusion criteria on standard questionnaires, and clinical interview questions. We also describe how we manage the exclusion process during screening, ensure continued psychological health during the laboratory study, and manage study terminations. We present data from one recent study, outlining the number of individuals excluded at each stage of the process and present subjective mood data from the included individuals, showing the trajectory of mood across the five-week laboratory study and the end-of-study debriefing, during which the participants rated their comfort with various aspects of the study and their willingness to return for a future study. While designed for our inpatient research studies, elements of these procedures may also be useful for selecting individuals for other exceptional environments.
在保护参与者免受潜在不良后果影响的同时,选择构成代表性样本的参与者是临床研究人员所关心的问题。我们的研究小组在长达3个月的长期实验室实验中对昼夜节律系统和睡眠-觉醒调节进行深度表型研究,这在很多方面类似于“特殊环境”条件。在此,我们描述我们使用了30多年的心理筛查过程。我们在心理、心理生理和社会心理因素这三大类中概述我们的“入选”和“排除”措施。我们描述筛查过程、标准问卷上的纳入-排除标准以及临床访谈问题。我们还描述我们在筛查期间如何管理排除过程、在实验室研究期间确保参与者持续的心理健康以及处理研究终止情况。我们展示一项近期研究的数据,概述该过程每个阶段被排除的个体数量,并展示纳入个体的主观情绪数据,呈现五周实验室研究期间及研究结束后的汇报中情绪的变化轨迹,在此期间参与者对研究的各个方面的舒适度以及他们未来参与研究的意愿进行评分。虽然这些程序是为我们的住院研究设计的,但这些程序的要素可能也有助于为其他特殊环境选择个体。