Quality of RecoveryNCT03711552
Validation of an Obstetric QoR Score and to Establish Its MCID.
An observational study of Quality of Recovery and Caesarean Section, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Recovery, Caesarean Section
- What is being tested?
- ObsQoR-11 and QoR-15
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- 31 Oct 2018to 20 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant females for caesarean section.
Who may be able to join
- Caesarean section.
- Age >18 years.
Who cannot join
- Inability to read or understand English.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validation of an Obstetric QoR (Quality of Recovery) Score and to Establish Its MCID (Minimally Clinically Important Difference) in an Irish Population.
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.
Read the 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:
- Internal consistency - the averaged correlation between each of the items within theObsQoR-11.
- Split half reliability - assessed by evaluating the correlation between random split segments.
- Test-retest reliability - a subset of patients will be reassessed at 30-60 minutes and the correlation between scores assessed.
- Floor and ceiling effects - this will be evaluated by whether <15% of patients achieved the highest (110/110) or lowest (0/110) possible scores.
Responsiveness is a measure of the ability to detect a clinically important change.
- Cohen effect size - the mean change in scores from before surgery to 24 hours after surgery divided by the standard deviation at baseline.
- Standardised response mean - the change in the scores before surgery to 24 hours after surgery divided by the standard deviation of the change in scores.
- Mean ObsQoR-11 scores - mean scores compared before surgery to 24 hours after surgery.
Feasibility
- Assessment of recruitment rate.
- Successful recruitment rate.
- Time taken to complete the ObsQoR-11.
The MCID will be determined based on an anchor-based method. The change in the mean score of the ObsQoR-11 score will be compared to the patient's own assessment of her change in health status using a Likert scale. We opted to follow a similar statistical method from an influential paper for estimation of the MCID. This will be based on calculation of the 0.3 SD (standard deviation), SEM (standard error of the mean) and the 5% range.
- Conditions
- Quality of Recovery, Caesarean Section
- Being tested
- ObsQoR-11, QoR-15
- Keywords
- Caesarean, cesarean, ObsQoR-11, QoR-15, MCID, minimal clinically important difference, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObsQoR-11Other
Quality of recovery questionnaire
QoR-15Other
Quality of recovery questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Quality of recovery | All enrolled patients will be asked to complete the ObsQoR-11 and QoR-15 questionnaires pre-surgery if feasible and at 24 and 48 hours post-surgery. Receives: Other: ObsQoR-11; Other: QoR-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of ObsQoR-11 in an Irish population.
Validation of ObsQoR-11 in an Irish population - as per the COSMIN initiative.
Measured: 48 hours
Secondary outcomes (2)
Comparison of the the ObsQoR-11 with the QoR-15.
Comparison of the the ObsQoR-11 with the QoR-15 with regards to the domains of COSMIN initiative.
Measured: 48 hours
Calculation of the MCID of the ObsQoR-11 score.
Calculation of the MCID of the ObsQoR-11 score.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start31 Oct 2018
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruairi Irwin, Coombe Women and Infants University Hospital
- Investigators
- Terry Tan, Study director, Head of Department of Anaesthesia CWIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711552
- Sponsor's protocol ID
- CWIUH-QoR
- Status last verified
- Aug 2019
- First submitted
- 15 Oct 2018
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of an Obstetric QoR (Quality of Recovery) Score and to Establish Its MCID (Minimally Clinically Important Difference) in an Irish Population.
- ClinicalTrials.gov ID
- NCT03711552
- Acronym / sponsor ID
- CWIUH-QoR
- Conditions
- Quality of Recovery, Caesarean Section
- Keywords
- Caesarean, cesarean, ObsQoR-11, QoR-15, MCID, minimal clinically important difference, quality of recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Internal consistency - the averaged correlation between each of the items within theObsQoR-11.
- Split half reliability - assessed by evaluating the correlation between random split segments.
- Test-retest reliability - a subset of patients will be reassessed at 30-60 minutes and the correlation between scores assessed.
- Floor and ceiling effects - this will be evaluated by whether <15% of patients achieved the highest (110/110) or lowest (0/110) possible scores.
Responsiveness is a measure of the ability to detect a clinically important change.
- Cohen effect size - the mean change in scores from before surgery to 24 hours after surgery divided by the standard deviation at baseline.
- Standardised response mean - the change in the scores before surgery to 24 hours after surgery divided by the standard deviation of the change in scores.
- Mean ObsQoR-11 scores - mean scores compared before surgery to 24 hours after surgery.
Feasibility
- Assessment of recruitment rate.
- Successful recruitment rate.
- Time taken to complete the ObsQoR-11.
The MCID will be determined based on an anchor-based method. The change in the mean score of the ObsQoR-11 score will be compared to the patient's own assessment of her change in health status using a Likert scale. We opted to follow a similar statistical method from an influential paper for estimation of the MCID. This will be based on calculation of the 0.3 SD (standard deviation), SEM (standard error of the mean) and the 5% range.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of recovery | – | Other: ObsQoR-11, Other: QoR-15All enrolled patients will be asked to complete the ObsQoR-11 and QoR-15 questionnaires pre-surgery if feasible and at 24 and 48 hours post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant females for caesarean section.
Key inclusion criteria (2 listed)
- Caesarean section.
- Age >18 years.
Key exclusion criteria (2 listed)
- Inability to read or understand English.
- Patient refusal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObsQoR-11Quality of recovery questionnaire | Other | Quality of recovery |
| QoR-15Quality of recovery questionnaire | Other | Quality of recovery |
Primary outcome
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.
2 secondary outcomes
Comparison of the the ObsQoR-11 with the QoR-15.
Time frame: 48 hours
Calculation of the MCID of the ObsQoR-11 score.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Tan study director
Head of Department of Anaesthesia CWIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery and Caesarean Section, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of ObsQoR-11 in an Irish population. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.