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

产后睡眠障碍显著影响产后恢复、孕产妇健康和母婴 二分体人们对产后睡眠作为一种结构、产后睡眠障碍或它们之间的联系知之甚少 精神健康数据仅限于使用内容不充分的措施的小型非种族多样化队列 效度我们的试点工作表明，三分之一的产后睡眠障碍患者有共病， 产后抑郁症是母亲自杀的主要原因。我们建议测试我们的总体假设， 产后睡眠评估不足，产后睡眠障碍诊断不足， 产后抑郁症睡眠障碍结构化临床访谈（SCISD-R）诊断常见DSM- 5睡眠障碍，包括失眠症。然而，SCISD-R在研究环境之外并不实用。 腕戴式体动仪也可以用来客观地测量睡眠。相反，患者报告 结果测量（PRO）是廉价的，自我报告的工具，可用于评估产后良好- 在大的cohort中。我们最近的工作强调，现有的睡眠专业人员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，和保护产妇 睡觉时间临床医生目前缺乏强大的PRO来评估产后睡眠和筛查产后睡眠 紊乱因此，我们建议开发，校准和验证敏感的，特定于上下文的睡眠PRO 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局测量信息 System®（PROMIS®）“间隙”方法：（1）调整现有的PROMIS睡眠障碍和睡眠相关 通过识别新的PRO项目来减少PRO在产后的使用，从而提高其内容效度， 与≥75名利益相关者进行定性访谈和焦点小组会议， ≥20例患者;（2）通过心理测量评估校准并最终确定适应性产后睡眠PRO， 一个种族和社会经济多样化的640人队列（160名白色非西班牙裔，白色西班牙裔，黑人和 在加利福尼亚州的斯坦福大学和阿肯色州的小石城的两家医院招募的女性。女性会完全入睡， 在产后4个时间点（住院、3和6个时间点）的全球健康和爱丁堡产后抑郁量表PRO 周，6个月）。SCISD-R也将在其中300名6周和6个月的妇女中进行，作为一项黄金研究。 在50名妇女中，睡眠数据，（日， 夜间和总清醒时间），也将在体动记录仪和适应性PRO之间进行比较;以及（3） 使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PRO的严格验证将支持其广泛用于评估产后睡眠，筛查 睡眠障碍，找出差距，探讨与产后抑郁症的联系，并促进孕产妇健康， well-being.因此，拟议的研究与2021年NIH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.