Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Not yet enrolling

Conditions

Well-Being, Psychological

Treatments

Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)

Other: EQ-5D-3L1 (not an acronym)

Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version)

Study type

Observational

Funder types

Other

Identifiers

NCT06002763

23-03

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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are unable to give or have withdrawn consent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.