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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Well-Being, Psychological
• Intervention / Treatment: Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System); Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version); Other: EQ-5D-3L1 (not an acronym)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ronald George, MD; Phone Number: 2681 416-586-4800; Email: ron.george@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital
      • Sub-Investigator: Kristi Downey, MSc
      • Contact: Ronald George, MD; Phone Number: 2681 416-586-4800; Email: ron.george@uhn.ca
      • Sub-Investigator: Denise Medeiros, MD
      • Sub-Investigator: Fernanda Septimio Lanza Oliveira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver vaginally or by scheduled cesarean section at Mount Sinai Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaginal delivery; Patients who have vaginal deliveries with neuraxial labour analgesia.	Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System); PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.; Other Names: Patient-Reported Outcomes Measurement Information System; Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version); The 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.; Other Names: World Health Organization Quality of Life Brief Version; Other: EQ-5D-3L1 (not an acronym); The 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).; Other Names: Global state of health numerical rating score 1-100
Cesarean delivery; Patients who have a scheduled cesarean delivery with neuraxial anesthesia.	Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System); PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.; Other Names: Patient-Reported Outcomes Measurement Information System; Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version); The 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.; Other Names: World Health Organization Quality of Life Brief Version; Other: EQ-5D-3L1 (not an acronym); The 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).; Other Names: Global state of health numerical rating score 1-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score	The PROMIS survey score at 24 hours postpartum	24 hours
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score	The WHOQoLBREF survey score at 24 hours postpartum	24 hours
EQ-5D-3L1 (not an acronym) survey score	The EQ-5D-3L1 survey score at 24 hours postpartum	24 hours
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score	The PROMIS survey score at 2 weeks postpartum	2 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score	The WHOQoLBREF survey score at 2 weeks postpartum	2 weeks
EQ-5D-3L1 (not an acronym) survey score	The EQ-5D-3L1 survey score at 2 weeks postpartum	2 weeks
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score	The PROMIS survey scores at 6 weeks postpartum	6 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score	The WHOQoLBREF survey score at 6 weeks postpartum	6 weeks
EQ-5D-3L1 (not an acronym) survey score	The EQ-5D-3L1 survey score at 6 weeks postpartum	6 weeks
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score	The PROMIS survey score at 12 weeks postpartum	12 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score	The WHOQoLBREF survey score at 12 weeks postpartum	12 weeks
EQ-5D-3L1 (not an acronym) survey score	The EQ-5D-3L1 survey score at 12 weeks postpartum	12 weeks

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Ronald George, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cesarean delivery; vaginal delivery; postpartum recovery
• Other Study ID Numbers: 23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No