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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

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 volunteers

Qualifiers

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are unable to give or have withdrawn consent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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    PROMIS-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 intervention

    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.

  • EQ-5D-3L1 (not an acronym)

    Other intervention

    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).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Vaginal delivery3 interventions
Group B: Cesarean delivery3 interventions

Trial outcomes

Primary outcomes

1

PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score

The PROMIS survey score at 24 hours postpartum

Time frame
24 hours
2

WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score

The WHOQoLBREF survey score at 24 hours postpartum

Time frame
24 hours
3

EQ-5D-3L1 (not an acronym) survey score

The EQ-5D-3L1 survey score at 24 hours postpartum

Time frame
24 hours
4

PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score

The PROMIS survey score at 2 weeks postpartum

Time frame
2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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