About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years old and over
singleton births
37 or more weeks gestational age
multiparous or nulliparous patients
Disqualifiers
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are unable to give or have withdrawn consent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
Trial population
Patients who deliver vaginally or by scheduled cesarean section at Mount Sinai Hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)
Other interventionPROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.
WHOQoLBREF (World Health Organization Quality of Life Brief Version)
Other interventionThe WHOQOL-BREF is a 26-item version of the 100-item WHOQOL-100 quality of life measure that addresses four quality of life domains: physical health, psychological health, social relationships and environment.
EQ-5D-3L1 (not an acronym)
Other interventionThe EQ-5D-3L1 is a generic measure of health status consisting of two parts. The first part assesses health in five dimensions: MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY/DEPRESSION. The second part of the questionnaire consists of a VAS on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Treatment groups
Trial outcomes
Primary outcomes
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey score at 24 hours postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
The WHOQoLBREF survey score at 24 hours postpartum
EQ-5D-3L1 (not an acronym) survey score
The EQ-5D-3L1 survey score at 24 hours postpartum
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey score at 2 weeks postpartum
Sponsors and contacts
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