Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
研究概览
简要总结
There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for the assessment of these factors in a generic population, but has not been specifically evaluated for use with postpartum women.
This study is a longitudinal, single center observational cohort study designed to evaluate the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. While this survey has shown utility in other populations, it has yet to be assessed in an obstetric population. The investigators plan to recruit patients who are recently postpartum from vaginal or cesarean delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after delivery). The investigators will subject survey data to statistical measures of validity and reliability comparing with contemporaneously collected surveys of established metrics for quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score 1-100).
The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable means of assessing physical and mental health in a postpartum population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years old and over
- •singleton births
- •37 or more weeks gestational age
- •multiparous or nulliparous patients
- •spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or neuraxial anesthesia
- •give informed written consent
排除标准
- •refusal to take part
- •are unable to give or have withdrawn consent
- •patients unable to communicate fluently in English
- •patients who are less than 18 years old
- •patients who had fetal demise or severely morbid fetal conditions such as intubation, cooling, expected surgical correction of congenital anomaly during hospitalization (although NICU admissions will be included)
- •patients who were admitted in ICU
- •patients who had failed neuraxial analgesia such as replaced epidurals or failed spinal requiring conversion to general anesthesia
- •patients who had general anesthesia for cesarean delivery as defined by "GETA", including sedatives and deep sedation if not intubated
- •patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum, forceps) vaginal delivery.
结局指标
主要结局
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
时间窗: 12 weeks
The PROMIS survey score at 12 weeks postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
时间窗: 12 weeks
The WHOQoLBREF survey score at 12 weeks postpartum
EQ-5D-3L1 (not an acronym) survey score
时间窗: 12 weeks
The EQ-5D-3L1 survey score at 12 weeks postpartum
次要结局
未报告次要终点