Development and Validation of a PROMIS-based Measure to Assess Postpartum Sleep

产后睡眠受损严重影响产后康复、产妇健康和母婴 二元组。关于产后睡眠作为一种概念、产后睡眠障碍或它们之间的联系，人们知之甚少 与心理健康有关。数据仅限于使用内容不充分的措施的非种族多样性的小群体 有效性。我们的试点工作表明，三分之一的产后睡眠障碍患者患有共病。 产后抑郁症是导致母亲自杀的主要原因。我们建议测试一下我们的总体假设 产后睡眠没有得到充分的评估，产后睡眠障碍被低估并与 产后抑郁症。睡眠障碍结构化临床访谈(SCISD-R)诊断常见的DSM- 睡眠障碍5例，包括失眠障碍。然而，SCISD-R在研究环境之外是不切实际的。 戴在手腕上的运动记录仪也可以用来客观地测量睡眠。相比之下，患者报告的 结局测量(PRO)是一种廉价的自我报告工具，可用于评估产后状况。 在一个大群体中。我们最近的研究表明，现有的睡眠专家没有充分评估重要的 产后睡眠领域，如婴儿睡眠、夜间喂养模式、觉醒和受保护的产妇 睡觉时间到了。临床医生目前缺乏强有力的专业人员来评估产后睡眠和筛查产后睡眠 精神错乱。因此，我们建议开发、校准和验证敏感的、特定于上下文的睡眠专业人员 它捕捉产后睡眠的症状和维度，同时筛查产后睡眠障碍。 为了实现这一目标，我们将实施新的患者报告结果测量信息 System®(PROMIS®)“GAP”方法：(1)适应现有的PROMIS睡眠障碍和与睡眠相关的 通过确定新的PRO项目来改善其内容有效性，从而为产后使用提供损害PRO，通过 与≥75利益相关者进行定性访谈和焦点小组会议，并与 ≥20例患者；(2)通过产后心理测量评估，校准和最终确定产后适应睡眠专业人员。 种族和社会经济多样化的队列640人(非西班牙裔白人160人，西班牙裔白人，黑人和 亚裔)在加利福尼亚州斯坦福和阿肯色州小石城的两家医院招募的女性。女人会完全入睡， 全球健康和爱丁堡产后抑郁量表在4个产后时间点(住院患者，3和6 几周，六个月)。SCISD-R也将在这些妇女中的300名在6周和6个月时进行，作为黄金 标准，以确定适应的PRO的筛查敏感性和特异性。在50名女性中，睡眠数据，(白天， 夜间和总清醒时间)，也将比较活动记录仪和改编后的专业人员；以及(3) 用因果推理方法描述产后睡眠及其与产后抑郁症的关系。 对睡眠专家的严格验证将支持它们的广泛使用，以评估产后睡眠，筛查 睡眠障碍，找出差异，探索与产后抑郁的联系，并促进孕产妇健康和 幸福。因此，这项拟议的研究与2021年美国国立卫生研究院睡眠研究计划的目标3和4非常一致。

Impaired postpartum sleep significantly impacts postpartum recovery, maternal health, and the maternal-infant dyad. Little is known about postpartum sleep as a construct, postpartum sleep disorders, or their association with mental health. Data are limited to small non-racially diverse cohorts using measures with inadequate content validity. Our pilot work demonstrates that one-third of patients with a postpartum sleep disorder have co-morbid postnatal depression, a leading cause of maternal suicide. We propose to test our overall hypothesis that postpartum sleep is inadequately assessed, and postpartum sleep disorders are underdiagnosed and linked to postnatal depression. The Structured Clinical Interview for Sleep Disorders (SCISD-R) diagnoses common DSM- 5 sleep disorders, including insomnia disorder. However, SCISD-R is impractical outside research settings. Wrist-worn actigraphy devices can also be used to measure sleep objectively. In contrast, patient-reported outcome measures (PROs) are inexpensive, self-reported tools, which can be used to assess postpartum well- being in large cohorts. Our recent work highlights that existing sleep PROs inadequately assess important postpartum sleep domains such as infant sleep, nocturnal feeding patterns, awakenings, and protected maternal sleep time. Clinicians currently lack robust PROs to assess postpartum sleep and screen for postpartum sleep disorders. We therefore propose developing, calibrating, and validating sensitive, context-specific, sleep PROs that capture the symptoms and dimensions of postpartum sleep, while screening for postpartum sleep disorders. To achieve this objective, we will implement novel Patient-Reported Outcomes Measurement Information System® (PROMIS®) ‘gap’ methodology to: (1) adapt existing PROMIS Sleep Disturbance and Sleep-Related Impairment PROs for postpartum use by identifying new PRO items, which improve their content validity, through qualitative interviews and focus group meetings with ≥75 stakeholders and cognitive debriefing interviews with ≥20 patients; (2) calibrate and finalize the adapted postpartum sleep PROs through psychometric evaluation in a racially and socioeconomically diverse cohort of 640 (160 White non-Hispanic, White Hispanic, Black and Asian) women recruited across two hospitals in Stanford, CA and Little Rock, AR. Women will complete sleep, global health and Edinburgh Postnatal Depression Scale PROs at 4 postpartum time points (inpatient, 3 and 6 weeks, 6 months). SCISD-R will also be conducted in 300 of these women at 6 weeks and 6 months, as a gold standard, to determine screening sensitivity and specificity of the adapted PROs. In 50 women, sleep data, (day, nocturnal and total awake time), will also be compared between actigraphy and the adapted PROs; and (3) characterize postpartum sleep and its association with postnatal depression using causal inference approaches. Rigorous validation of the sleep PROs will support their widespread use to assess postpartum sleep, screen for sleep disorders, identify disparities, explore links with postnatal depression, and to promote maternal health and well-being. As such the proposed study aligns well with Goals 3 and 4 of the 2021 NIH Sleep Research Plan.