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Development and Evaluation of An Obstetric Quality-Of-Recovery Score (Obsqor-11) After Elective Caesarean Delivery
Development and Evaluation of An Obstetric Quality-Of-Recovery Score (Obsqor-11) After Elective Caesarean Delivery
Development and Evaluation of An Obstetric Quality-Of-Recovery Score (Obsqor-11) After Elective Caesarean Delivery
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doi: 10.1016/j.bja.2018.06.011
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Clinical Investigation
CLINICAL INVESTIGATION
Abstract
Background: Whilst validated quality-of-recovery (QoR) tools exist for general surgery, there is no specific obstetric
equivalent. We aimed to develop and evaluate a modified QoR score after elective caesarean delivery.
Methods: Twenty-two obstetric specific items were selected following review and modification of the QoR-40 survey by
16 experts and interviews with 50 stakeholders. Item selection was based on relevance to caesarean delivery and
endorsement by >66% of stakeholders. Items were tested on women pre-delivery, at 24 h, and 25 h post-delivery. An 11-
item obstetric-specific QoR score (ObsQoR-11) was created based on correlation with a numerical rating scale (NRS) of
global health status (r>0.20) at all time points. Reliability, responsiveness, acceptability, and feasibility were tested.
Results: One hundred and fifty-two women responded to the 22-item questionnaire pre-delivery (complete in 146), 100 at
24 h, and 10 at 25 h. The ObsQoR-11 correlated with the global health status NRS (r¼0.53; 95% confidence interval:
0.43e0.62; P<0.0001) and discriminated good vs poor recovery (NRS score 70 vs <70 mm) at 24 h. There was a negative
correlation between the ObsQoR-11 score at 24 h and hospital length of stay (r¼e0.39; P¼0.003). ObsQoR-11 was reliable
(internal consistency: 0.85; split-half 0.76; testeretest intra-class correlation coefficient ri>0.6 in 82% of items) and
responsive (Cohen effect size: 1.36; standardised response mean: 0.85). A longer 22-item ObsQoR had high (97%)
completion rates and short (median: 2 min) completion times.
Conclusions: The ObsQoR-11 provides a valid, reliable, and responsive global assessment of recovery after elective
caesarean delivery.
1
2 - Ciechanowicz et al.
Domains QoR-40 Items removed (X) Obstetric items Draft 31 items Items removed Draft 22-item scale ObsQoR-11 scale
after expert review added after expert
review
Physical comfort Able to breathe Able to breathe Able to breathe Able to breathe Able to breathe
Good sleep Good sleep Good sleep X
Enjoy food X
Itchiness Itchiness Itchiness Itchiness
Feel rested Feel rested Feel rested X
Nausea Nausea Nausea Nausea or Nausea or Nausea or
Vomiting Vomiting Vomiting vomiting* vomiting vomiting
Dry retching X
Dry lips/mouth Dry lips/mouth X
Restless X
Shaking/twitching X
Shivering Shivering Shivering Shivering Shivering Shivering
Too cold X
Dizzy Dizzy Dizzy Dizzy Dizzy Dizzy
Emotional state General well-being X
In control In control In control In control In control In control
Comfortable Comfortable Comfortable Comfortable Comfortable Comfortable
Bad dreams X
Anxious Anxious Anxious Anxious Anxious
Angry X
Depressed Depressed Depressed Depressed Depressed
-
staff staff staff staff staff
3
Communicate with X
family
Continued
4 - Ciechanowicz et al.
Moderate pain
Severe pain
(r>0.20) with the global health status NRS assessment and
confirmed with post hoc factor analysis (see web-Supplement).
We conducted factor analysis and found that 21 items
(including all 11 items of the ObsQoR-11) were identified from
11
the original 22 items selected in the stage (iii). There were four
Communicate with
Draft 22-item scale
Perineal pain
Understand
Severe pain scoring tool was evaluated post hoc to determine the following:
Headache
partner
22
sample of women, ObsQoR-11 was assessed by two
nauseaþvomiting
subtypes of construct validity: convergent and
Communicate with
8 items removed;
discriminant validity, and content validity, which are
combined; 31
Items removed
Moderate pain
instructions
outlined as follows:
Perineal pain
Understand
Severe pain
instructions
Perineal pain
Severe pain
Headache
19þ12¼31
40e21¼19
Understand
Severe pain
Backache
X
X
Sore mouth
Severe pain
Sore throat
Headache
Confused
Backache
CD.
(iv) Acceptability and feasibility were assessed by evaluating
40
Statistical analysis
Pain
The sample size for this study was guided by previous studies,
as power calculation is not reliable for correlation analysis.2
Development and evaluation of ObsQoR-11 - 5
Fig 1. Flow diagram summarising the study methodology and ObsQoR-11 development. CD, caesarean delivery; ObsQoR, obstetric-specific
QoR; QoR, quality of recovery.
Data are presented as mean (SD), median [inter-quartile range ObsQoR version. No additional items were added at this stage,
(IQR)], number (%), and 95% confidence intervals (CIs). A c2 as no new items were suggested by more than one stakeholder.
analysis was used to compare stakeholder groups in the We recruited 152 women to the next stage of the study, all
formulation phase. Continuous data were tested for normality of whom filled out the 22-item version of the ObsQoR
using the ShapiroeWilk and KolmogoroveSmirnov normality
tests; all percentages were rounded up to the nearest integer.
Correlations between the 22-item ObsQoR questionnaire items Table 2 Patient, obstetric, and clinical characteristics of the
study group (n¼152 women). CD, caesarean delivery; IQR,
(which contain ObsQoR-11 items) and global health NRS scores
inter-quartile range; number (%); SD, standard deviation; VD,
were determined using Spearman rank correlation coefficients vaginal delivery
(r). Non-parametric data were compared using Wilcoxon
signed-rank test. Internal consistency was measured with Variable
Cronbach’s alpha.11 The testeretest reliability was measured
by intra-class correlation coefficient. Post hoc factor analysis Age (yr)
was performed on the 22-item ObsQoR. We selected factors Mean (SD) 34.6 (5.6)
Range 20e50
based on eigenvalue >1. Items with loading >0.4 were selected
Length of hospital stay (h)
for each factor. The internal consistency of each factor was Median (IQR) 36.5 (33e59.6)
assessed by Cronbach’s alpha. Statistical analysis was per- Range 26e204
formed using GraphPad Software (7.0; USA) and SAS Institute, Pre-existing medical conditions
USA. The null hypothesis was rejected if the two-tailed P-value Respiratory 8 (5)
was <0.05. Cardiovascular 7 (5)
Neurological 7 (5)
Endocrine 9 (6)
Haematological 4 (3)
Results Musculoskeletal 1 (1)
Psychiatric 4 (3)
The formulation of the ObsQoR-11 from QoR-40 items is sum- Others 4 (3)
marised in Table 1. Thirty-one recovery items were initially Indication for elective CD
included from five dimensions: pain, physical comfort, physical Previous CD 49 (46)
independence and care of the neonate, psychological support, Breech 18 (17)
Maternal request 18 (17)
and emotional state. The items subsequently removed after
Abnormal placentation 5 (5)
endorsement by <2/3 of stakeholders are outlined in Previous traumatic VD 5 (5)
Supplementary Table S1 and Supplementary Figure S2. The Fetal pathology 3 (3)
resultant 22-item ObsQoR questionnaire is shown in Twins 3 (3)
Supplementary Figure S1. Based on feedback from multiple Cardiovascular 2 (2)
patients that found it difficult to define and distinguish between Neurological 2 (2)
Age 1 (1)
‘nausea’ and ‘vomiting’, these items were combined to form a
single item ‘nausea or vomiting’, before inclusion in the 22-item
6 - Ciechanowicz et al.
Fig 2. Final ObsQoR-11 questionnaire and global health NRS scoring. ObsQoR, obstetric-specific QoR; QoR, quality of recovery.
Development and evaluation of ObsQoR-11 - 7
Table 3 Inter-item correlation matrix for final ObsQoR-11. NRS, numerical rating scale; ObsQoR, obstetric quality of recovery. ObsQoR-
11 items taken from shortlisted ObsQoR-22 items with correlation to global health NRS. 1¼moderate pain; 2¼severe pain; 3¼nausea or
vomiting; 4¼feeling dizzy; 5¼shivering; 6¼have been comfortable; 7¼able to mobilise independently; 8¼can hold my baby without
assistance; 9¼can feed/nurse baby without assistance; 10¼can look after personal hygiene/toilet; 11¼feeling in control
1 0.45 0.71 d
2 0.43 0.72 0.68 d
3 0.28 0.56 0.34 0.39 d
4 0.25 0.63 0.35 0.41 0.47 d
5 0.23 0.61 0.35 0.42 0.45 0.49 d
6 0.42 0.55 0.33 0.37 0.17 0.25 0.14 d
7 0.28 0.56 0.33 0.32 0.21 0.28 0.49 0.22 d
8 0.22 0.49 0.25 0.29 0.17 0.28 0.42 0.19 0.59 d
9 0.22 0.54 0.26 0.25 0.24 0.3 0.47 0.24 0.54 0.71 d
10 0.28 0.57 0.31 0.31 0.29 0.38 0.40 0.23 0.63 0.57 0.54 d
11 0.37 0.43 0.15 0.18 0.27 0.27 0.32 0.55 0.33 0.24 0.34 0.30 d
questionnaire prior to CD, 100 at 24 h and 10 at 25 h after negative correlation with duration of hospital stay (r¼e0.39;
surgery; six questionnaires had incomplete or missing data, P¼0.003). There was a positive association between preopera-
and were therefore excluded from the analysis, leaving 146 tive ObsQoR-11 and maternal age (r¼0.22; P¼0.027), but not to
complete pre-CD questionnaires. There were two incomplete 24 h post-ObsQoR-11 scores (r¼e0.13; P¼0.31).
questionnaires filled at 24 h, leaving 98 complete question- The inter-item correlation matrix for the ObsQoR-11 is
naires and no incomplete data at 25 h. The clinical charac- presented in Table 3. The split-half reliability was 0.76. The
teristics of women who filled the preoperative 22-item ObsQoR testeretest reliability of the ObsQoR-11 items was ri>0.6 in 82%
questionnaire are presented in Table 2. The final 11 items of items and >0.5 in the remaining items, suggesting adequate
included in the ObsQoR-11 were determined by excluding repeatability and reliability. The percentage of women
ObsQoR items from the combined pre-CD and 24 h post-CD achieving the highest possible ObsQoR-11 score was 6% (n¼8)
questionnaires that failed to achieve a Spearman correlation before operation and 0% (n¼0) at 24 h postoperatively; there-
of 0.2 to global health NRS scores at their corresponding time fore, no floor or ceiling effects of the questionnaire were
point (Supplementary Table S2; Fig. 2). demonstrated (Supplementary Fig. S4). The ObsQoR-11 scores
A post hoc factor analysis of the 22-item ObsQoR identified were negatively skewed (levels of skewness were e1.89 pre-
four underlying factors, which explained more than 93% of the operative and e0.78 at 24 h postoperatively), indicating that
variance. A Scree plot of factor loading is provided in the majority of the ObsQoR-11 total scores were in the upper
Supplementary Figure S3. Item clustering in the four factors is half of the scale (>55).
outlined as follows, with items included in ObsQoR-11 distin- Responsiveness to change for the ObsQoR-11 was excellent
guished in italics: (Cohen effect size: 1.36), indicating an important change from
pre- to post-CD. The standardised response mean was 0.85,
(i) Factor 1: shivering, dizziness, difficulty breathing, nausea or
which also indicates a large effect (Table 4). There was a sig-
vomiting, headache, severe pain, feeling depressed, itchy,
nificant difference between the pre- and 24 h postoperative
and perineal pain
ObsQoR-11 scores (median difference: e14; P<0.0001), sup-
(ii) Factor 2: ability to communicate with staff, communicate
porting clinical utility (Table 4). Box plots of the total ObsQoR-
with family, understand instructions, hold baby, feed baby,
11 pre- and post-CD are presented in Supplementary Figure S5.
and feeling in control
Although the clinical acceptability and feasibility of the
(iii) Factor 3: personal hygiene, ability to pass urine, mobilise
ObsQoR-11 were not formally assessed, there were no refusals
independently, and full sensation to the body
to complete the longer 22-item ObsQoR questionnaire with all
(iv) Factor 4: feeling comfortable and moderate pain
of those approached agreeing to complete the questionnaires
The total combined (pre- and 24 h post-CD) ObsQoR-11 pre-CD and post-CD. One hundred (66%) women completed
scores correlated with the combined pre- and 24 h post-CD both the pre- and post-CD 22-item ObsQoR questionnaires;
global health NRS scores [Spearman r¼0.53 (95% CI: drop out was attributable to early discharge or absence at the
0.43e0.62); P<0.0001]. The preoperative ObsQoR-11 scores time of interviewer attendance. Eight questionnaires (six pre-
correlated to the preoperative global health NRS scores [r¼0.46 CD and two post-CD) were excluded from the analysis because
(0.31e0.59); P<0.0001], and also to the postoperative global of incomplete data, therefore attaining a 97% inclusion rate
health NRS scores (r¼0.25; P¼0.019). The post-CD ObsQoR-11 overall. The median time [IQR] taken to complete the 22-item
scores correlated to the 24 h post-CD global health NRS scores ObsQoR questionnaire (n¼93) was 2 [2e3] min, range: 1e10
[r¼0.44 (0.26e0.60); P<0.0001]. min.
The ObsQoR-11 scores differed significantly for women
who had a good or poor postoperative recovery. The median
[IQR] ObsQoR-11 scores at 24 h were 100 [91.3-105] for good
Discussion
recovery vs 87 [72-95] for poor recovery (P<0.0001). The median This study developed and evaluated an obstetric-specific re-
[IQR] hospital stay for women in the study was 36.5 h [33e59.6], covery scoring tool, the ObsQoR-11, for use in patients un-
with a range of 26e204 h (Table 2). ObsQoR-11 at 24 h had a dergoing elective CD. The ObsQoR-11 performed well in
8 - Ciechanowicz et al.
Table 4 Change in recovery status of women before caesarean delivery (preoperative baseline) and again at 24 h after caesarean
delivery (postoperative). Mean (SD). CI, confidence interval; Cohen effect size, mean change in score divided by the baseline (preop-
erative) SD; QoR, quality of recovery; SD, standard deviation; standardised response mean, mean change in score divided by its SD.
Scored on an 11-point numerical Likert scale (0e10).
Final ObsQoR-11 item Preoperative Postoperative Mean change Change from Cohen effect Standardised
(95% CI) baseline (%) size response mean
1. Moderate pain 7.5 (2.8) 4.9 (2.1) 2.6 (1.9e3.3) 35 0.95 0.77
2. Severe pain 8.7 (2.7) 6.9 (3.0) 1.7 (0.9e2.5) 20 0.64 0.42
3. Nausea or vomiting 8.6 (2.7) 7.9 (2.4) 0.7 (0.1e1.3) 8 0.25 0.22
4. Feeling dizzy 8.7 (2.6) 7.6 (2.4) 1.4 (0.8e2.0) 16 0.53 0.45
5. Shivering 9.2 (2.4) 8.3 (2.5) 1.0 (0.4e1.7) 11 0.43 0.33
6. Have been 6.5 (2.8) 5.3 (5.7) 0.9 (0.3e1.6) 14 0.33 0.28
comfortable
7. Able to mobilise 9.5 (1.6) 7.6 (2.9) 1.8 (1.1e2.5) 18 1.15 0.53
independently
8. Can hold baby 9.8 (1.1) 8.4 (2.5) 1.3 (0.6e2.0) 13 1.14 0.37
without assistance
9. Can feed/nurse baby 9.5 (1.7) 7.9 (2.8) 1.5 (0.7e2.2) 16 0.89 0.40
without assistance
10. Can look after 9.8 (1.1) 8.2 (2.7) 1.6 (0.9e2.2) 16 1.43 0.46
personal hygiene/toilet
11. Feeling in control 8.9 (2.1) 8.2 (2.2) 0.5 (e0.2 to 1.1) 6 0.25 0.15
Total 96.7 (13.1) 80.6 (17.6) 17.9 (13.6e22.2) 19 1.36 0.85
measures of reliability, responsiveness, clinical acceptability, immediate postoperative period, and omit pertinent items
and feasibility. There was moderate correlation of 24 h regarding recovery following caesarean delivery. NRS scores
ObsQoR-11 scores to 24 h global health NRS scores. However, for global health and pain scores, although quick to measure,
the ObsQoR-11 was not independently evaluated on a patient do not provide a holistic indication of patient-reported func-
sample, and therefore, future work is needed to validate tional recovery.6,7
ObsQoR-11 and determine its generalisability. The post hoc To develop an obstetric-specific QoR score, we started with
factor analysis confirmed that the selected 11 items contrib- a broad selection of recovery items, and then evaluated and
uted significantly to the four underlying factors. Factor 1 rep- refined the tool in five stages. ObsQoR-11 contains no items
resents physical comfort and pain. Factor 2 covers both from the ‘psychological support’ domain, which could imply
physical independence and emotional state. Factor 3 repre- that recovery factors relating to self-efficacy and functional
sents physical independence, and Factor 4 is a supplement to ability are more important for CD-related health than the
Factor 1. perceived support from staff or relatives during hospital-
Recovery after surgery is a multidimensional process, the isation. Post hoc assessment of reliability, responsiveness,
definition of which varies from clinician or patient perspec- clinical acceptability, and feasibility of ObsQoR-11 appears to
tive. Clinically, our focus has been to achieve the functions be very good to excellent, which is encouraging for future
necessary to allow for early discharge from hospital. However, validation studies. ObsQoR-11 can discriminate between good
more recently, assessment tools of recovery have expanded and poor postoperative recovery in patients undergoing elec-
from single one-dimensional measures of physiological vari- tive CD, without floor and ceiling effects.17 A perfect final
ables to more continuous holistic assessments, including ObsQoR-11 score is 110, which was not achieved by any
physical, nociceptive, emotive, cognitive, and functional out- woman assessed at 24 h after surgery. A 24 h ObsQoR-11 score
comes.12,13 Available recovery assessment tools are heteroge- of 100 is associated with a ‘good’ health status at 24 h (NRS
neous in content and timing of assessment, with a 70), and therefore, a good recovery, whereas a median score
combination of subjective and objective outcomes, and com- of 87 is associated with a ‘poorer’ health status (NRS <70) or
posite and dichotomous scoring. The currently available re- poor recovery outcome after elective CD in this patient cohort.2
covery assessment tools are not extensively validated for use The post hoc assessment of ObsQoR-11 convergent validity
in the obstetric population, and therefore, may be irrelevant revealed a moderate correlation to global health NRS score,
for the elective CD population.13 comparable with QoR-15 and the more extensive QoR-40, used
Recovery scoring tools have been shown to be sensitive in for general postoperative recovery evaluation.12 However, the
detecting clinically important differences in recovery after ObsQoR-11 correlation with global health NRS fell short of the
non-obstetric surgery.14 Perioperative interventions that >0.6 value recommended for scoring tools.18 Yet, the upper
result in a change of 0.9 for the QoR score, 8.0 for QoR-15, or 6.3 limit of the 95% CI does include 0.6, suggesting ObsQoR-11 may
for QoR-40 signify a clinically important improvement or have utility in predicting QoR as measured by the NRS of global
deterioration.14 Whilst the QoR-40 is a well-established health status. The global health NRS score has not been psy-
scoring tool,1 it takes approximately 10 min to complete. The chometrically evaluated and may overrate the general well-
previous QoR scales and other scores described in the litera- being in obstetric patients. Therefore, it may not be the ideal
ture, including short-term quality of life,8 the surgical recovery score or ‘gold standard’ to compare ObsQoR-11 with. We also
index,15 and recovery of bowel function scoring tools,16 were demonstrated that ObsQoR-11 negatively correlates with hos-
not specifically designed to measure recovery in the pital stay, further supporting the use of this tool in measuring a
Development and evaluation of ObsQoR-11 - 9
clinically important outcome related to recovery. Interestingly, same day of surgery, in the morning, which may have influ-
ObsQoR-11 correlated positively with age before surgery, but enced the baseline ObsQoR-11 scores because of the presence
not after, which could indicate better psychological prepara- of anxiety and the effects of fasting and fatigue. We chose to
tion for CD with age or prior experience of childbirth. measure QoR scores at 24 h post-CD, as this is becoming a
Discriminant validity was determined by comparing desirable standard for discharge from hospitals with enhanced
women who had good or poor postoperative recovery, defined recovery programmes, as recommended by the National
by the global health NRS score.12 The internal consistency, as Institute for Health and Care Excellence.19,20 We did not test for
measured using Cronbach’s alpha and split-half reliability, the reproducibility of ObsQoR-11 beyond 25 h, as has been
was high. These values were within recommended limits demonstrated for QoR-15 in day surgery.3 In the future, we aim
(0.7e0.9),18 and were comparable with those reported with to validate ObsQoR-11 in the early (24e48 h), intermediate (1
QoR-152 and QoR-40.1 The inter-item correlation also deter- week), and late (6e8 weeks) recovery periods post-CD.
mined the internal consistency, with values indicating good In summary, we have developed an obstetric-specific re-
correlation of items within ObsQoR-11, each adding its own covery tool (ObsQoR-11) for use in patients undergoing CD, by
dimension to the recovery status. adapting the QoR-40 questionnaire. ObsQoR-11 performed
The reproducibility (testeretest reliability) of ObsQoR-11 well in measures of reliability, responsiveness, clinical
was excellent, with 82% of items having a correlation of >0.6. acceptability, and feasibility. The questionnaire appears to be
The short duration (30e60 min) between test and retest means an easy-to-use recovery outcome measure, which could be
that any meaningful improvement in recovery is unlikely to utilised as a standardised patient-centred tool to evaluate re-
have occurred, but this was vulnerable to testeretest bias. The covery and well-being in the obstetric population. However,
responsiveness of ObsQoR-11 (assessed using Cohen effect future work is needed to validate ObsQoR-11, determine its
size and standardised response means to measure the relative generalisability, and evaluate its role in unplanned CD and
size of postoperative change in ObsQoR-11 score) was excel- after assisted vaginal delivery. Further testing for reproduc-
lent. ObsQoR-11 had a large Cohen effect size of 1.36 and a ibility beyond 24 h is desirable. In addition, exploring the
large standardised response mean of 0.85, suggesting signifi- relationship between ObsQoR-11 and other markers of recov-
cant differences in ObsQoR-11 score pre- and 24 h post-CD. ery and postoperative morbidity would further validate this
These values are greater than QoR-40 and are comparable instrument.
with QoR-15, supporting the ability of ObsQoR-11 to detect
clinically significant differences in recovery, potentially mak-
ing it useful in trials, quality improvement and clinical prac- Authors’ contributions
tice. Individual item effect sizes ranged from low to high, but Study design: S.C., P.S., C.S., M.C., J.D.
most items had moderate to strong responsiveness. The Data collection: S.C., P.S., T.S., E.R., C.S.
acceptability and feasibility of ObsQoR-11 were very good. The Data analysis: S.C., P.S., M.C., B.C.
median [IQR] time taken to complete the ObsQoR-22 ques- Data interpretation: S.C., P.S., B.C.
tionnaire was 2 [2e3] min, and we anticipate the shorter Manuscript preparation: S.C., P.S., M.C., B.C.
ObsQoR-11 would be completed in significantly less time than
this. The clinical brevity of ObsQoR-11 in practice may also
make it less prone to bias from non-response. Acknowledgements
There was only a weak correlation of pre-CD ObsQoR-11 to The authors would like to thank N. Guo for invaluable contri-
24 h global health NRS scores. These results would not support butions in performing factor analysis of the data.
the use of pre-ObsQoR-11 scores as a predictor of post-
operative recovery in this setting. We, therefore, recommend
this scoring tool be used for evaluation, not prediction, of Declaration of interest
postoperative recovery.
The authors declare that they have no conflicts of interest.
Our study had several limitations. The 66% response rate at
24 h was mainly attributable to women not being present at
the planned interview time rather than refusal to complete the Appendix A. Supplementary data
questionnaire. This makes our data vulnerable to selection
bias, as we may have missed more women with a good 24 h Supplementary data related to this article can be found at
recovery. It also highlights the difficulties in obtaining patient- https://doi.org/10.1016/j.bja.2018.06.011.
reported postoperative scores in obstetric clinical practice.
Only 10% of women repeated the postoperative test at 25 h,
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