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

开发和验证基于 PROMIS 的产后睡眠评估措施

• 批准号: 10735614
• 负责人: Pervez Sultan
• 金额: $ 57.62万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10735614
• 关键词: Arkansas; Asian; Black race; Calibration; California; Circadian Rhythm Disorder; Clinical; Cognition; Cognitive; DSM-V; Data; Development; Devices; Diagnosis; Dimensions; Disease; Disparity; Equipment; Evaluation; Family Relationship; Fatigue; Feeding Patterns; Focus Groups; Future; Goals; Group Meetings; Hispanic; Hospitals; Impairment; Infant; Infant Development; Information Systems; Inpatients; Intervention; Interview; Link; Maternal Health; Measurement; Measures; Mental Depression; Mental Health; Methodology; Moods; Mothers; Not Hispanic or Latino; Outcome Measure; Patient Outcomes Assessments; Patient Self-Report; Patients; Personal Satisfaction; Physical activity; Population Heterogeneity; Postpartum Depression; Postpartum Period; Psychometrics; Race; Recovery; Research; Research Personnel; Restless Legs Syndrome; Sensitivity and Specificity; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Structure; Suicide; Surveys; Symptoms; Testing; Time; United States National Institutes of Health; Validation; Woman; Work; Wrist; actigraphy; antenatal; awake; cohort; comorbidity; design; ethnic diversity; experience; falls; global health; improved; maternal wellbeing; novel; patient oriented; patient population; postpartum health; prospective; racial disparity; racial diversity; recruit; screening; service providers; socioeconomics; sound; tool

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.

产后睡眠受损显着影响产后恢复、孕产妇健康和母婴 关于产后睡眠的结构、产后睡眠障碍或其关联，人们知之甚少。 数据仅限于小型非种族多样化群体，使用的措施内容不足。 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。 产后抑郁症是孕产妇自杀的主要原因。我们建议检验我们的总体假设： 产后睡眠评估不充分，产后睡眠障碍诊断不足且与以下因素有关： 睡眠障碍结构化临床访谈 (SCISD-R) 诊断常见的 DSM- 5 睡眠障碍，包括失眠障碍 然而，SCISD-R 在研究环境之外是不切实际的。 相比之下，腕戴式体动记录仪也可用于客观测量睡眠。 结果测量（PRO）是廉价的自我报告工具，可用于评估产后健康状况 我们最近的研究强调，现有的睡眠 PRO 的重要性评估不充分。 产后睡眠领域，例如婴儿睡眠、夜间喂养模式、觉醒和受保护的产妇 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。 因此，我们建议开发、校准和验证敏感的、针对具体情况的睡眠 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，我们将实施新颖的患者报告结果测量信息 System® (PROMIS®)“差距”方法用于：(1) 调整现有的 PROMIS 睡眠障碍和睡眠相关 通过识别新的 PRO 项目来削弱产后使用的 PRO，从而提高其内容有效性，通过 与 ≥75 名利益相关者进行定性访谈和焦点小组会议，以及与 ≥20名患者；（2）通过心理测量评估校准并最终确定调整后的产后睡眠PRO 640 名具有种族和社会背景的多元化群体（160 名非西班牙裔白人、西班牙裔白人、黑人和 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亚洲）女性将完成睡眠， 全球健康和爱丁堡产后抑郁量表 PRO 在 4 个产后时间点（住院、3 和 6 SCISD-R 还将在 6 周和 6 个月内对其中 300 名女性进行，作为黄金 标准，以确定调整后的 PRO 的筛查敏感性和特异性 在 50 名女性中，睡眠数据（日， (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，找出差异，探索与产后抑郁症的联系，并促进孕产妇健康和 因此，拟议的研究与 2021 年 NIH 睡眠研究计划的目标 3 和 4 非常吻合。