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 [8]. All methods were carried out following the Strengthening the Reporting of Observational Studies in Epidemiology guideline [9]. 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 Patients who were lack of fluency in Turkish, inability to read or understand written Turkish and inability to obtain written informed consent due to neuropsychiatric disorders such as schizophrenia, mental retardation, seizures with eclampsia and addiction were excluded from the study that may bias the ObsQoR-11T measurements.
Development of the ObsQoR-11T
Permission was received from the author of the original English language version of the ObsQoR-11 scale. The translation technique was performed as per the recommendations of Beaton and Bullinger [10]. First, two 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 using a daily working list with a simple randomly selected cohort of ten nurses. All ObsQoR-11T questions were confirmed to be comprehensible. The final ObsQoR-11T is shown in Fig. 1.
Data collection
Informed written 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 elective scheduled CD, the ObsQoR-11T scale was explained to the patient and consent gained. Before an emergency CD, while the patient was in the preoperative room consent gained. The ObsQoR-11T was administered at 24th hour following CD. At the 25th hour, a computer-assisted randomization program (random.org) was used to determine a random subset of 20 patients prior to complete the ObsQoR-11T scale once again. The researchers, who were members of the perioperative care team, were on hand to assist the patients the ObsQoR-11T. 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. There is no routine approach for general anesthesia and is dependant on the anesthesiologist, 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 h after the spinal anesthesia, patients are encouraged to mobilize, and 8 h 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, 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 min later (at 25 h), which was correlated to the 24-h 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
The normal distribution of the continuous variables was tested using the Kolmogorov–Smirnov test. Measurement data are presented as mean ± standard deviation (SD), median (min–max) and categorical data are presented as frequency and percentage number (%). Differences in distribution were analysed by the Kruskal– Wallis test and Mann–Whitney U-test. Difference in distribution of categorical data was analysed by Fisher’s exact test and Chi-square test.
To achieve structural validity, confirmatory factor analysis (CFA) was performed.
It is suggested that sample size should be at least 10–15 times the number of items [11, 12]. According to Lacobucci, 50 can be sufficient for minimum sample size and 100 can be sufficient for maximum sample size [13]. ObsQoR-11 scale consisted of 4 dimensions and 11 items. It can be said that sample size of this study (160) is sufficient for CFA. CFA was performed using the Mplus 7 program [14]. To estimate the CFA model parameters, the Robust Maximum Likelihood estimation (MLR) method was used.
Correlations between the ObsQoR-11T items and VAS scores were measured using the Spearman rank (ρ) correlation coefficient. Internal consistency was measured using Cronbach’s α and split-half reliability. Test–retest reliability was measured using the intraclass correlation coefficient. All statistical analyses were performed using IBM SPSS statistics for Windows, version 25.0.; IBM Corp, Armonk, NY, USA. Differences were considered statistically significant when the P-value was < 0.05.