The Validation of an Obstetric QoR (Quality of Recovery) Score and to Establish Its MCID (Minimally Clinically Important Difference) in an Irish Population.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Validation of ObsQoR-11 in an Irish population.
Study Overview
Brief Summary
The ObsQoR-11 is an 11-item survey that was recently developed to evaluate recovery after caesarean section. This has been shown to be valid, feasible, reliable and responsive to changes in health status. The aim of this study to validate the ObsQoR-11 score in an Irish obstetric hospital. The collection of supplemental data will allow its comparison to the QoR-15 score and calculation of the MCID.
Detailed Description
The investigators aim to perform a prospective observational study of term parturients undergoing caesarean section. Patients undergoing elective and emergency caesarean section will be eligible for inclusion. Patients will be invited to fill out the survey before their caesarean section if feasible and then again at 24 and 48 hours. A subset of patients will be asked to repeat the second survey 30-60 minutes later to assess test-retest reliability. The patient demographics will be recorded at the initial survey. The time taken to fill out the 11-item ObsQoR-11 will be recorded. The QoR-15 score will also be completed at the same time and will allow comparison of the scores. The patient's Global health score will be assessed on a 0-100 scale from worst imaginable health state to best imaginable health state. At 24 and 48 hours patients will be asked to rate their overall recovery from surgery yesterday on a 15-point scale ranging from -7 to +7. This will facilitate an anchor-based determination of the MCID.
The validation of the ObsQoR-11 score will follow as per the Consensus based Standards for the selection of health Measurement Instruments (COSMIN) initiative. The assessment tool will be evaluated under the domains of validity, reliability, responsiveness and feasibility. The QoR-15 score will be similarly assessed to allow a comparison.
Validity will be assessed using two separate methods:
- Convergent and discriminant validity - Comparison of the ObsQoR-11 score to 100mm Global health score.
- Content validity - ObsQoR-11 will be assessed for correlation with patient age and length of hospital stay.
Reliability as a measure of consistency will be assessed based on the following methods:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Caesarean section.
- •Age >18 years.
Exclusion Criteria
- •Inability to read or understand English.
- •Patient refusal.
Outcomes
Primary Outcomes
Validation of ObsQoR-11 in an Irish population.
Time Frame: 48 hours
Validation of ObsQoR-11 in an Irish population - as per the COSMIN initiative.
Secondary Outcomes
- Comparison of the the ObsQoR-11 with the QoR-15.(48 hours)
- Calculation of the MCID of the ObsQoR-11 score.(48 hours)
Investigators
Ruairi Irwin
Principal investigator
Coombe Women and Infants University Hospital