Coombe Women and Infants University Hospital
Dublin, 00000, Ireland
NCT Number: NCT03711552
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Dublin, 00000, Ireland
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:
Reliability as a measure of consistency will be assessed based on the following methods:
Responsiveness is a measure of the ability to detect a clinically important change.
Feasibility
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quality of recovery questionnaire
Quality of recovery questionnaire
Time frame: 48 hours
Validation of ObsQoR-11 in an Irish population - as per the COSMIN initiative.
Time frame: 48 hours
Comparison of the the ObsQoR-11 with the QoR-15 with regards to the domains of COSMIN initiative.
Time frame: 48 hours
Calculation of the MCID of the ObsQoR-11 score.
Coombe Women and Infants University Hospital
Other
The Validation of an Obstetric QoR (Quality of Recovery) Score and to Establish Its MCID (Minimally Clinically Important Difference) in an Irish Population.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07337668
Behavior, Behavioral Symptoms
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT05847842
Hernia, Hernia, Abdominal
Eskişehir, Turkey (Türkiye)
View Trial DetailsNCT06343753
Elective Laparoscopic Cholecystectomy, Neurologic Manifestations
Cairo, Egypt
View Trial DetailsNCT04807504
Local Anesthetic Systemic Toxicity, Neurologic Manifestations
Philadelphia, Pennsylvania, United States
View Trial Details