Patient selection
This prospective observational cohort study of term women undergoing CD was approved by the Ethics Committee of Gülhane Education and Research Hospital, Turkey (No. 2021/506), and registered with ClinicalTrials.gov (NCT04744311, February 8, 2021). Written informed consent was obtained from all the participants. The study was conducted in line with the principles of the Declaration of Helsinki (6). All methods were carried out following the Strengthening the Reporting of Observational Studies in Epidemiology guideline (7). Patients who underwent surgery at the hospital between January 2021 and August 2021 were enrolled.
Women aged >18 years who underwent CD at ≥37 weeks of pregnancy, and were able to read and speak Turkish, were included in the study. Exclusion criteria were lack of fluency in Turkish, inability to obtain written informed consent, and neuropsychiatric disturbance that may bias the ObsQoR-11T measurements.
Development of the ObsQoR-11T
Permission was received from the author (Doctor Sarah Ciechanowicz) of the original English language version of the ObsQoR-11 scale. The translation technique was performed as per the recommendations of Beaton and Bullinger (8). First, two authors (co-authors UK and MEI) translated the ObsQoR-11 into Turkish with reference to the Turkish version of the validated QoR-40 (QoR-40T) (4). A temporary Turkish version of the ObsQoR-11 was agreed upon, which was then back-translated by a third person (co-author SŞ; healthcare experience in the USA and Turkey). Subsequently, a consensus was made regarding the ObsQoR-11T. The ObsQoR-11T was then tested in a randomly selected cohort of ten intensive care unit nurses. All ObsQoR-11T questions were confirmed to be comprehensible. The final ObsQoR-11T is shown in Table 1.
Data collection
Informed consent was obtained from each patient before surgery. Demographic characteristics were recorded preoperatively. Intraoperative features were obtained from electronic and written patient records. On the morning of the CD, the ObsQoR-11T scale was explained to the patient. The ObsQoR-11T was administered before (in the waiting section of the operating room) and at the 24th hour (in the clinic room) after the CD. At the 25th hour, a random subset of 20 patients was requested to complete the ObsQoR-11T scale once again. A computer-assisted randomization program was used to determine these patients prior to the study's start. The time required to complete each ObsQoR-11T scale was recorded. The general well-being was measured with a 100-mm global health visual analog scale (VAS) with the ObsQoR-11T questionnaire. The VAS scale ranges from 0 to 100 mm, indicating poor to best possible recovery. The ObsQoR-11T scale and the VAS scale were administered using self-assessment, with assistance as required.
Our institutional neuraxial anesthesia regimen includes intrathecal administration of hyperbaric bupivacaine 12–15 mg, with fentanyl 15 mcg, via a single spinal injection. Depending on the anesthesiologist, various analgesics are used during general anesthesia. There is no routine approach. For postoperative analgesia, patients regularly received paracetamol 1 g four times daily unless contraindicated. Patients are also routinely prescribed i.m. diclofenac 75 mg as required after surgery. Intravenous ondansetron 4 mg as required were also prescribed unless contraindicated. Generally, 6 hours after the spinal anesthesia, patients are encouraged to mobilize, and 8 hours after, a trial without a urinary catheter is attempted.
Psychometric evaluation of the ObsQoR-11T
To measure the convergent validity, the correlation between ObsQoR-11T score and global health VAS score was evaluated. Discriminant validity was tested by comparing the ObsQoR-11T score in two groups divided by the VAS (≥70 mm [good] vs. <70 mm [poor]). To measure the construct validity, the correlation of continuous parameters with the ObsQoR-11T was evaluated. The ObsQoR-11T scores were compared in terms of education level, presence of comorbidities, history of abdominal surgery, parity groups, history of cesarean section, need for elective or emergency cesarean section, emergency category for emergency cesarean section, and type of anesthesia.
Cronbach's alpha, split-half reliability, and test-retest reliability were used to measure reliability. The test-retest reliability was analyzed in a subgroup of women who were asked to complete the questionnaire 60 minutes later (at 25 hours), which was correlated to the 24-hour results. The intra-class correlation coefficient was used to assess test-retest reliability. The floor and ceiling effects were calculated by determining if 15% of respondents received the greatest or lowest possible score. The recruitment rate, completion rate, and time taken to complete the scale were used to assess acceptability and feasibility (the investigator measured).
Statistical analysis
There is no standard approach to determining sample size in scale validity and reliability studies. It is typically recommended that a minimum of 150 participants be used, or that 10 to 20 times the frequency of items on the scale be used. As the original ObsQoR-11 scale was an 11-item scale, we aimed for 200 patients. A total of 180 patients were included in the study due to data loss and other reasons.
Measurement data are presented as mean (SD), and categorical data are presented as frequency and percentage, number (%). The normal distribution of the continuous variables was tested using the Kolmogorov-Smirnov test. Correlations between the ObsQoR-11T items and VAS scores were measured using the Spearman rank (ρ) correlation coefficient. Internal consistency was measured using Cronbach α and split-half reliability. Test-retest reliability was measured using the intraclass correlation coefficient. T-test and ANOVA were used to compare continuous parametric data, and the chi-square test was used to compare categorical data. All statistical analyses were performed using SPSS version 25.0 for Windows (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). The null-hypothesis was rejected if the two-tailed P-value was < 0.05.