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International Journal of Obstetric Anesthesia 49 (2022) 103235

Contents lists available at ScienceDirect

International Journal of Obstetric Anesthesia


journal homepage: www.elsevier.com/locate/ijoa

Original Article

Validation of an obstetric quality of recovery scoring tool (ObsQoR-11) after


elective caesarean delivery in a developing country: a prospective
observational study
S. Kumar a, V. Ashok a,⇑, D. Jain a, A. Arora b, A. Singh b, P. Sikka b
a
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
b
Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India

A R T I C L E I N F O A B S T R A C T

Keywords: Background: The obstetric quality of recovery scoring tool (ObsQoR‐11) was developed and validated in the
Caesarean delivery, elective United Kingdom for use after elective and emergency caesarean delivery. Quality of recovery scoring tools val-
Developing country idated in one country may not be valid in other countries with significant cultural, socio‐economic and linguis-
Quality of recovery tic variations. The aim of the current study was to validate a Hindi version of the ObsQoR‐11.
Methods: In this prospective observational study, 100 parturients who underwent elective caesarean delivery
in a tertiary care obstetric referral university hospital in North India were asked to complete a Hindi version
of the ObsQoR‐11 scoring tool 24 h after surgery. The performance of the Hindi version of ObsQoR‐11 was
assessed using measures of validity, reliability, and feasibility.
Results: The Hindi version of ObsQoR‐11 correlated moderately with the global health visual analogue scale
(r=0.45, 95% CI 0.27 to 0.59; P <0.0001) and discriminated well between good and poor recovery (mean
(SD) score 84.6 (9.4) vs 75.0 (11.2); P <0.0001). The reliability and internal consistency were moderate
(Cronbach’s alpha=0.66; Spearman‐Brown Prophesy Reliability estimate=0.57) with good repeatability (intr-
aclass correlation coefficient 0.85, 95% CI 0.69 to 0.93; P <0.0001) and no floor or ceiling effects. All parturi-
ents completed the questionnaire in a (median (IQR) time of completion of 3 (1.5 – 5.5) min).
Conclusion: The Hindi version of the ObsQoR‐11 questionnaire is a promising scoring tool to evaluate quality of
recovery after elective caesarean delivery. Further research is needed to evaluate the Hindi tool in other insti-
tutions in India as well as in other languages.

Introduction ObsQoR‐11 questionnaire contained items derived from four clinically


relevant dimensions of good postoperative quality of recovery, includ-
Recovery after caesarean delivery is a multidimensional process ing physical comfort, emotional state, physical independence and care
that is dependent on a range of patient, anaesthetic and surgical fac- of the newborn, and pain. Notably, the ObsQoR‐11 includes key items
tors. Measures of postoperative outcome usually focus on morbidity such as the ability to care for, and nurse, the newborn. These are
and mortality, which do not necessarily describe the patient’s experi- important components of good patient outcomes after childbirth.
ence or quality of recovery (QoR) after surgery. The ObsQoR‐11 scoring tool was subsequently validated in non‐
While scoring tools like the QoR‐40 and QoR‐15 have been devel- elective caesarean delivery.4
oped and validated to evaluate recovery outcomes in patients undergo- Self‐reported QoR after anaesthesia and surgery is often difficult to
ing non‐obstetric and same‐day surgical procedures,1,2 until recently assess as it is frequently affected by cultural, educational and socio‐
there has been no validated scoring tool to assess recovery after cae- economic factors. Patients’ self‐perception of their health is likely to
sarean delivery. For the first time, Ciechanowicz et al.3 developed depend on their expectations about what is ‘normal’, as well as the
and evaluated an obstetric quality of recovery score (ObsQoR‐11) for knowledge about their health and health problems.5 The ObsQoR‐11
specific use in parturients who had undergone elective caesarean scoring tool is in the English language, developed and validated in par-
delivery. As a modified version of the earlier QoR‐40 survey, the turients in the United Kingdom; as such, it might not be directly appli-

⇑ Correspondence to: Dr V Ashok, Department of Anaesthesia and Intensive Care, Level 4, Nehru Hospital, PGIMER, Chandigarh 160012, India.
E-mail address: vighneshmmc@gmail.com (V. Ashok).

https://doi.org/10.1016/j.ijoa.2021.103235
Accepted 24 October 2021
0208-5216/© 2021 Elsevier Ltd. All rights reserved.
S. Kumar et al. International Journal of Obstetric Anesthesia 49 (2022) 103235

cable to childbirth in Indian institutions, which have a significantly Outcomes measured


more challenging environment that includes lower literacy levels,
greater poverty, and varied cultural and religious beliefs. The performance of the ObsQoR‐11 scoring tool was assessed using
We conducted this study to validate the ObsQoR‐11 scoring tool in measures of validity (convergent, discriminant, content), reliability
women after elective caesarean delivery in a single institution in India, (internal consistency, split‐half reliability, test–retest reliability and
with the hypothesis that the ObsQoR‐11 developed and validated in floor/ceiling effects) and feasibility as described by the COnsensus‐
the United Kingdom would not be valid in a demographically different based Standards for the Selection of health Measurement INstruments
setting such as India. The reliability and the feasibility of the ObsQoR‐ (COSMIN) group.7
11 scoring tool to measure patient‐reported outcomes were also
evaluated. (i). For convergent validity the ObsQoR‐11 scores were correlated
with the 100‐mm global health status VAS scores. Discriminant
validity was assessed by comparing the 24‐h ObsQoR‐11
Methods scores of patients who had ‘good’ or ‘poor’ recovery, defined
by global health status VAS scores of ≥70 mm and <70 mm,
This prospective observational study was conducted in a tertiary respectively. For content validity, the ObsQoR‐11 scores were
care obstetric referral hospital in Northern India after institutional correlated with factors that could have a potential effect on
ethics committee approval (NK/6235/Study/750, Institute Ethics the parturients’ quality of recovery after caesarean delivery.
Committee, Post‐Graduate Institute of Medical Education and These included length of hospital stay, maternal age, maternal
Research, Chandigarh, India, September 2020). The hospital and the education levels, maternal occupation, parity, American Soci-
peri‐operative anaesthesia protocol followed for elective caesarean ety of Anesthesiologists physical status score, and the type of
deliveries is described in Supplementary Material 1. anaesthesia received.
(ii). Reliability of the ObsQoR‐11 tool was assessed by evaluating
the internal consistency using Cronbach’s alpha and split‐half
Study participants reliability using the Spearman‐Brown Prophesy Reliability esti-
mate. The test–retest reliability was assessed by repeating the
Women scheduled for elective caesarean delivery under either neu- ObsQoR‐11 questionnaire on a convenience subset sample of
raxial or general anaesthesia, aged ≥18 years and who could read and 25 patients 60 min after the first completion, and evaluating
understand the questionnaire in Hindi were eligible for inclusion in the intra‐class correlation coefficient.
the study. Women who could not read and understand Hindi and those (iii). Feasibility was assessed by evaluating ease of recruitment, suc-
who declined to participate in the study were excluded. cessful completion of the paper forms and time taken to com-
plete the ObsQoR‐11 scoring tool.

Study design and conduct


Statistical analysis
Translation of the English version of the ObsQoR‐11 questionnaire
to Hindi was performed as per the guidelines recommended for cross‐ Data were presented using measures of central tendency and mea-
cultural adaptation of health‐related measures.6 The English version of sures of dispersion. Normality of data was tested using the Shapiro‐
the ObsQoR‐11 was translated by two independent bilingual speakers Wilk and Kolmogorov‐Smirvov tests of normality. Normally dis-
(Hindi and English) to Hindi and subsequently back‐translated by two tributed data were compared using the Student’s t‐test, while skewed
other independent bilingual speakers (Hindi and English) to ensure data were compared using the Mann‐Whitney U test. Correlation
accuracy of the translation process. The Hindi version of the analysis was done using Spearman rank coefficients (r). The null
ObsQoR‐11 questionnaire was further reviewed by bilingual medical hypothesis was rejected if the two‐tailed P‐value was <0.05. All sta-
experts before being piloted on a sample of 12 parturients scheduled tistical analyses were done using IBM SPSS statistics software, ver-
for elective caesarean delivery. The questionnaire did not need any sion 27.0.
further modifications after the pilot study (Supplementary Material 2). The ObsQoR‐11 score had not yet been validated in a non‐English‐
speaking setting and data regarding patient‐reported QoR after cae-
sarean delivery from Asian countries were lacking. A convenience sam-
Recruitment and data collection ple size of 100 was chosen based on previously published studies
evaluating the ObsQoR‐11 scoring tool.3,4
The study patients were recruited consecutively by the anaesthesia
senior registrar (SK) or consultant (VA), based on their availability.
Written informed consent was obtained from the study participants Results
at the time of recruitment. Relevant demographic and clinical data
of the study patients were collected at the time of study enrolment. The study was conducted from October 2020 to March 2021. One
The participating women were requested to complete the Hindi ver- hundred patients recruited completed the study and the returned
sion of the ObsQoR‐11 questionnaire 24 (±2) h after the completion paper forms were complete with no missing data. The patient demo-
of surgery, rating each item of the questionnaire on an 11‐point Likert graphic, obstetric and anaesthetic details are presented in Table 1.
scale (0–10). The researchers were available at the patient’s bedside in The most common indication for caesarean delivery was previous cae-
case the participants faced any difficulty in completing the question- sarean delivery and not suitable/willing for a trial of labour after cae-
naire. The participants were also asked to rate their global health sta- sarean. Most of the caesarean deliveries were performed under
tus on a 100 mm visual analogue scale (VAS) anchored on the left with neuraxial anaesthesia employing a single‐shot subarachnoid block
‘worst imaginable health state’ and on the right with ‘best imaginable with bupivacaine and fentanyl. The individual items of the ObsQoR‐
health state’. All data were recorded on a standardised paper data col- 11 scoring tool are summarised in Table 2. The mean (SD) global
lection form and were subsequently transferred to a Microsoft Excel health status VAS score and ObsQoR‐11 score were 69.4 (11.4) mm
spreadsheet with patient details anonymised. and 81.0 (11.0), respectively.

2
S. Kumar et al. International Journal of Obstetric Anesthesia 49 (2022) 103235

Table 1 Table 3
Patient, obstetric, and anaesthetic characteristics (n=100) Content validity of the ObsQoR-11 scoring tool

Variables Variable Spearman’s correlation coefficient [r (95% CI)] P-


value
Age (years) 30.4 (4.7)
Weight (kg) 70.8 (10.3) Maternal age 0.007 (−0.189 to 0.203) 0.94
Maternal education: school/graduate/postgraduate 47/40/13 Parity 0.077 (−0.120 to 0.269) 0.44
Maternal occupation: employed outside the home 12 Maternal education −0.108 (−0.297 to 0.090) 0.29
Parity: 0/1/2/3/4 22/43/31/2/ Maternal occupation −0.079 (−0.271 to 0.118) 0.43
2 ASA-PS 0.179 (−0.018 to 0.362) 0.07
ASA-PS: 2/3 95/5 Type of anaesthesia −0.026 (−0.221 to 0.171) 0.84
Length of hospital stay (days) 4 (3-5) Length of hospital stay −0.016 (−0.212 to 0.180) 0.87
Anaesthesia for caesarean delivery: neuraxial/ general anaesthesia 95/5
Pre-existing medical conditions (n) 16 CI: confidence interval; ASA-PS: American Society of Anesthesiologists phys-
Endocrine 13 ical status score.
Cardiac and/or cardiovascular 5
Neurological 1
Musculoskeletal 3 (iv). Feasibility. The median (interquartile range) time for comple-
Others
tion of the study questionnaire was 3 (1.5–5.5) min.
ASA-PS: American Society of Anesthesiologists physical status score.
Values are mean (SD), median (1st to 3rd quartile), or number.
Discussion

Primary outcome: ObsQoR-11 validity In this study of women undergoing elective caesarean delivery, we
demonstrated that the ObsQoR‐11 scoring tool performed moderately
(i). Convergent validity. The ObsQoR‐11 scores had moderate cor- well. While the discriminant validity and feasibility of the tool were
relation with the 100 mm global health status VAS scores good, the convergent validity and reliability of the scoring tool were
(r=0.45, 95% CI 0.27 to 0.59; P <0.0001). moderate. The content validity of the scoring tool was, however,
(ii). Discriminant validity. The ObsQoR‐11 scores were higher in limited.
women with ‘good recovery’ (n=63) compared with those with The ObsQoR‐11 scoring tool was developed and evaluated for elec-
‘poor recovery’ (n=37) (mean (SD) score; good recovery 84.6 tive caesarean deliveries at a single centre study in the United King-
(9.5), poor recovery 75.1 (11.2), t(98)=−4.5, P <0.0001). dom.3 The researchers reported a moderate strength of correlation
(iii). Content validity. The ObsQoR‐11 did not correlate with the between ObsQoR‐11 score and the global health status numerical rat-
length of hospital stay, maternal age, maternal education levels, ing scale (r=0.44).3 Consistent with these findings, we report similar
maternal occupation, parity, American Society of Anesthesiolo- convergent validity of the ObsQoR‐11 scoring tool in the current study.
gists physical status score or the type of anaesthesia received A threshold value of >0.6 has been recommended for correlation stud-
(Table 3). ies evaluating scoring tools in health science.8 While the ObsQoR‐11
correlation with the global health VAS score reported in the current
Secondary outcomes: ObsQoR-11 reliability and feasibility study was less than this threshold, the upper limit of the 95% CI of
the correlation coefficient nearly reached 0.6, suggesting possible util-
(i). Internal consistency and split‐half reliability were moderate ity of the ObsQoR‐11 scoring tool in measuring QoR after caesarean
(Cronbach’s alpha, 0.66; Spearman‐Brown Prophesy Reliability delivery in our setting. In agreement with earlier studies,3,4 we demon-
estimate, 0.57). The inter‐dimension correlation matrix for strated that the ObsQoR‐11 scoring tool had good discriminant valid-
ObsQoR‐11 is described in Table 4. ity, being able to distinguish between parturients with ‘good’ vs ‘poor’
(ii). Test re‐test reliability was good (intra‐class correlation coeffi- postoperative recovery. In contrast, the reliability of the ObsQoR‐11
cient 0.85, 95% CI 0.69 to 0.93; P <0.0001). scoring tool in our setting was only moderate, warranting further
(iii). Floor and ceiling effect. No participant had an ObsQoR‐11 score inter‐dimension analysis.
of 0 (lowest) or 110 (highest), which was well within the Postoperative quality of recovery involves several domains which
acceptable limit of <15%. were recognised during the development of the QoR‐40 scoring tool.
Myles et al.1 defined five clinically relevant dimensions which encom-
pass quality of postoperative recovery, including physical comfort,
Table 2 emotional state, psychological support, physical independence and
ObsQoR-11 individual items score (Q1-Q11) across four dimensions pain. Inter‐dimension analysis, in our study, demonstrated that the
ObsQoR-11 items Mean (SD)a correlations between the domains of the ObsQoR‐11 scoring tool with
the global health VAS score and ObsQoR‐11 score varied from poor to
Dimension 1 (Physical comfort)
good. The items pertaining to the dimension of ‘physical independence
Q3: Nausea or vomiting 9.3 (1.4)
Q4: Dizziness 8.9 (2.1) and care of newborn’ had the highest correlation with the global
Q5: Shivering 7.3 (2.7) health VAS score and ObsQoR‐11 scores, indicating the importance
Dimension 2 (Emotional state) new mothers place on the need for self‐sufficiency and their role as
Q6: Comfortable 7.6 (1.8) the caregiver for the newborn. The pain dimension had the lowest
Q11: Feeling in control 7.5 (1.5)
Dimension 3 (Physical independence and care of newborn)
strength of correlation with global health VAS score. Of interest is
Q7: Mobilise independently 7.2 (1.6) the observation that, despite the items in the ‘pain domain’ having
Q8: Hold baby without assistance 7.6 (1.8) the lowest scores in the ObsQoR‐11 scoring tool, there were no statis-
Q9: Feed/nurse baby without assistance 7.3 (1.9) tically significant correlations between postoperative pain and QoR
Q10: Personal hygiene/toilet 7.1 (2.2)
measured using the global health VAS score and ObsQoR‐11. It has
Dimension 4 (Pain)
Q1: Moderate pain 4.6 (2.4) been shown that patient reporting of pain varies significantly across
Q2: Severe pain 6.6 (2.9) cultures and is likely to be influenced by ethnic and cultural differ-
a
ences.9 In our setting, we found that parturients considered postoper-
Total possible score is 10 for each question.
ative pain as part of normal recuperation after surgery, which probably

3
S. Kumar et al. International Journal of Obstetric Anesthesia 49 (2022) 103235

Table 4
Inter-dimension correlation matrix for ObsQoR-11 following elective caesarean delivery

ObsQoR-11 dimensions VAS ObsQoR- 1 – Physical comfort 2 – Emotional state 3 – Physical independence and care of 4 – Pain
11 (n=3) (n=2) newborn (n=4) (n=2)

1 – Physical comfort 0.21 0.5 –


2 – Emotional state 0.37 0.73 0.2 –
3 – Physical independence and care of 0.43 0.77 0.16 0.68 –
newborn
4 – Pain 0.15 0.43 0.11 0.12 0.12 –

VAS: visual analogue scale. Each dimension consists of several items (denoted as n), as described in Table 2. All values expressed as correlation coefficient, r.

explains the lack of correlation between the pain items of the ObsQoR‐ tent validity, the scoring tool performed well with regards to its con-
11 scoring tool and the global health VAS scores. vergent and discriminant validity and was found to be feasible and
The reliability and repeatability of the Hindi version of the reliable. More research is needed to validate the Obs‐QoR scoring tool
ObsQoR‐11 scoring tool was comparable to that reported in the studies after vaginal and caesarean delivery, and in other languages.
from the United Kingdom.3,4 No participant refused to complete the
questionnaire and the time taken to complete the Hindi version of Funding
the questionnaire was comparable to the times reported in earlier
studies.3,4 This research did not receive any specific grant from funding agen-
The ObsQoR‐11 belongs to a family of scoring tools referred to as cies in the public, commercial, or not‐for‐profit sectors.
patient‐reported outcome measures (PROMs). The PROMs have shown
to be useful modalities to critically evaluate the health system in terms
Declaration of interests
of the quality of care provided.10 However, the use of validated PROMs
in pregnancy and childbirth is limited.11 Self‐reported outcome mea-
The authors report no conflicts of interest.
sures are influenced by socio‐economic, cultural and linguistic factors,
amongst others.12–14 Patients’ perception of their own health and
recovery depends on which aspects of the recovery he/she considers Acknowledgement
a ‘problem’, as opposed to aspects that are considered ‘normal.’ Hence,
caution is advised in attempting to use PROMs developed in the Wes- The authors wish to thank all the parturients who participated in
tern world in countries in Asia and Africa.5,15 this study.
To the best of our knowledge, our study is the first to attempt to
validate the ObsQoR‐11 scoring tool in an Asian country with signifi- Appendix A. Supplementary data
cant demographic, socio‐economic, and cultural differences compared
with the United Kingdom, where the scoring tool originated. There is a Supplementary data to this article can be found online at
need for sustained efforts to improve maternal healthcare delivery in https://doi.org/10.1016/j.ijoa.2021.103235.
settings like ours. As a means of evaluating the quality of maternal
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