A Cluster-Randomized Trial To Reduce Cesarean Delivery Rates in Quebec

The
n e w e ng l a n d j o u r na l
of
m e dic i n e
Original Article
A Cluster-Randomized Trial to Reduce

Cesarean Delivery Rates in Quebec
Nils Chaillet, Ph.D., Alexandre Dumont, M.D., Ph.D., Michal Abrahamowicz, Ph.D.,
JeanCharles Pasquier, M.D., Ph.D., Francois Audibert, M.D.,
Patricia Monnier, M.D., Ph.D., HaimA. Abenhaim, M.D., M.P.H., Eric Dub, M.Sc.,
Marylne Dugas, Ph.D., Rebecca Burne, M.Sc., and WilliamD. Fraser, M.D.,
for the QUARISMA Trial Research Group*
A BS T R AC T
BACKGROUND
From the Department of Obstetrics and
Gynecology, Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke,
QC (N.C., J.-C.P., E.D., W.D.F.), Department of Epidemiology and Biostatistics,
McGill University (M.A., R.B.), Department of Obstetrics and Gynecology, University of Montreal, Centre Hospitalier
Universitaire Sainte-Justine (F.A.), Department of Obstetrics and Gynecology,
McGill University, Royal Victoria Hospital (P.M.), and Department of Obstetrics
and Gynecology, McGill University, Jewish Hospital (H.A.A.), Montreal, and the
Population Health and Optimal Health
Practices Research Unit, CHU de Qubec
Research Centre, Quebec, QC (M.D.)
all in Canada; and the Research Institute
for Development, Universit Paris Descartes, Sorbonne Paris Cit, UMR 216,
Paris (A.D.). Address reprint requests to
Dr. Chaillet at the Departments of Obstetrics and Gynecology and Family Medicine, University of Sherbrooke, Faculty
of Medicine and Health Sciences CHUS,
3001, 12e Ave. Nord, Centre de Recherche Clinique, Local 2921, Sherbrooke, QC
J1H 5N4, Canada, or at n
ils
.
chaillet@
usherbrooke.ca.
In Canada, cesarean delivery rates have increased substantially over the past decade.
Effective, safe strategies are needed to reduce these rates.
METHODS
We conducted a cluster-randomized, controlled trial of a multifaceted 1.5-year intervention at 32 hospitals in Quebec. The intervention involved audits of indications
for cesarean delivery, provision of feedback to health professionals, and implementation of best practices. The primary outcome was the cesarean delivery rate in the
1-year postintervention period.
RESULTS
*A complete list of the members of the

Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA)
trial research group is provided in the
Supplementary Appendix, available at
NEJM.org.
Among the 184,952 participants, 53,086 women delivered in the year before the
intervention and 52,265 women delivered in the year following the intervention.
There was a significant but small reduction in the rate of cesarean delivery from
the preintervention period to the postintervention period in the intervention group
as compared with the control group (change, 22.5% to 21.8% in the intervention
group and 23.2% to 23.5% in the control group; odds ratio for incremental change
over time, adjusted for hospital and patient characteristics, 0.90; 95% confidence
interval [CI], 0.80 to 0.99; P=0.04; adjusted risk difference, 1.8%; 95% CI, 3.8 to
0.2). The cesarean delivery rate was significantly reduced among women with
low-risk pregnancies (adjusted risk difference, 1.7%; 95% CI, 3.0 to 0.3; P=0.03)
but not among those with high-risk pregnancies (P=0.35; P = 0.03 for interaction).
The intervention group also had a reduction in major neonatal morbidity as compared with the control group (adjusted risk difference, 0.7%; 95% CI, 1.3 to 0.1;
P=0.03) and a smaller increase in minor neonatal morbidity (adjusted risk difference, 1.7%; 95% CI, 2.6 to 0.9; P<0.001). Changes in minor and major maternal
morbidity did not differ significantly between the groups.
N Engl J Med 2015;372:1710-21.

DOI: 10.1056/NEJMoa1407120
CONCLUSIONS
Copyright 2015 Massachusetts Medical Society.
1710
Audits of indications for cesarean delivery, feedback for health professionals, and
implementation of best practices, as compared with usual care, resulted in a significant but small reduction in the rate of cesarean delivery, without adverse effects
on maternal or neonatal outcomes. The benefit was driven by the effect of the
intervention in low-risk pregnancies. (Funded by the Canadian Institutes of Health
Research; QUARISMA Current Controlled Trials number, ISRCTN95086407.)
n engl j med 372;18nejm.org April 30, 2015
The New England Journal of Medicine

Downloaded from nejm.org by Aini Fuada Sardjono on March 27, 2016. For personal use only. No other uses without permission.
Copyright 2015 Massachusetts Medical Society. All rights reserved.
A Trial to Reduce Cesarean Delivery R ates
ates of cesarean delivery are high

in developed countries.1-3 In Canada, these
rates increased from 21.2% to 28.0% between 2000 and 2008 and remained stable until
2011.4-6 High rates of cesarean delivery are of
substantial concern owing to the potential harm
to the mother and her baby associated with a
medically unnecessary cesarean delivery and to
the related costs of health care.7-15 Providing evidence-based guidance to health professionals
regarding the appropriate selection of women
who could benefit from cesarean delivery is now
a priority.
Systematic reviews of strategies designed to
reduce cesarean delivery rates and to improve the
quality of intrapartum care suggest that the dissemination of clinical practice guidelines alone
is generally ineffective; that educational strategies,
opinion leaders, quality- improvement strategies,
and academic detailing (university or noncommercial educational outreach) have mixed effects; that
audits of indications for cesarean delivery associated with the provision of feedback and reminders about clinical practices are generally effective;
and that multifaceted strategies may be more
effective than individual strategies.16-21 However,
data from large randomized trials have not been
available to assess the effects of a multifaceted
strategy involving audits and feedback on cesarean delivery rates and measures of quality of care.
We designed this trial to assess whether a
multifaceted intervention to promote professional
onsite training with audits and feedback would
reduce the rate of cesarean delivery. Secondary
objectives included assessment of the effects of
this strategy on other obstetrical interventions
and on maternal and neonatal outcomes.
Me thods
Hospitals and Participants
We conducted the QUARISMA (Quality of Care,

Obstetrics Risk Management, and Mode of Delivery) trial at 32 public hospitals in Quebec province from April 1, 2008, to October 31, 2011. To
be eligible to join the trial, hospitals were required
to have at least 300 deliveries in the year before
initiation of the study, a rate of cesarean delivery
higher than 17% (i.e., in the 10th percentile of the
distribution of cesarean deliveries in Quebec from
April 2006 to March 2007),22 and at the time of
recruitment, no recent or ongoing quality-improve-
ment programs specifically designed to reduce

the rate of cesarean delivery. All women who delivered at participating centers and whose newborns had a gestational age of at least 24 weeks
and weighed at least 500 g at delivery were included in the analysis.
Study Design and Oversight
The QUARISMA trial was a stratified, clusterrandomized, parallel-group trial in which hospitals were the units of randomization and women
were the units of analysis. By designating hospitals as the units of randomization, we ensured that
all women within a given maternity unit were assigned to the same trial group, thereby reducing
the risk of contamination of the intervention effect. Randomization was stratified according to
level of care (community, regional, or tertiary
hospital). The study included a 1-year preintervention (baseline) period, a 1.5-year intervention
period, and a 1-year postintervention period. After the baseline period, hospitals were randomly
assigned to the intervention group or the control
group. To avoid imbalance in the size of the two
groups, we used computer-generated, blocked randomization within each stratum, with blocks
consisting of four centers or, for strata with fewer
than eight hospitals, two centers. Local investigators at each hospital were then immediately informed of the assignment status of their hospital.
In-hospital data were abstracted by trained
research nurses or medical archivists from the
medical records of mothers and newborns
3 months after delivery; data were abstracted in
the same way at both intervention and control
hospitals. Data completeness and quality were
assessed every 3 months through onsite visits
and queries sent to onsite data collectors to resolve discrepancies identified by the data-management team. Data collectors were aware of the
randomization assignments but were not involved in outcomes assessment. Until the end of
the trial, access to the database was restricted to
the data manager. All steps involved in the management of clinical data were monitored annually and validated by an independent data and
safety monitoring board.
The trial received approval from the institutional review board at each participating hospital.
The first author assumes responsibility for the
completeness and integrity of the data and the
fidelity of the report to the study protocol, which

1711
The
of
m e dic i n e
is available with the full text of this article at mendations, and to provide feedback and ensure the implementation of the recommendations
NEJM.org.
(through regular staff meetings, training sesIntervention
sions, and informal discussions) was approxiThe QUARISMA program, which was imple- mately 2 days per 3-month cycle.
No intervention from the QUARISMA team
mented at the hospital level in the intervention
group, targeted physicians and nurses involved was planned for the control group. In order to
in the decision-making process for cesarean de- assess contamination bias, quality-improvement
liveries. The program consisted of initial onsite programs were reviewed annually in control
training in evidence-based clinical practices by hospitals.
instructors from the Society of Obstetricians and
Gynecologists of Canada, clinical audits, and im- Outcomes
plementation of best practices (for details see The primary outcome was the overall rate of
Section 2 in the Supplementary Appendix, avail- cesarean delivery. Secondary outcomes included
able at NEJM.org). A local opinion leader acted rates of planned and intrapartum cesarean delivas the facilitator at each site. No financial incen- ery, vaginal delivery with the use of instruments
tive was provided.
(i.e., forceps or vacuum), pharmacologic induction
The first 6 months of the 1.5-year interven- of labor, artificial rupture of membranes, augtion period focused on identifying the opinion mentation with oxytocin during labor, epidural
leader in each intervention hospital (with the use analgesia, and episiotomy; composite risks of miof surveys) and selecting the local audit commit- nor and major maternal complications; and comtee (which consisted of one or two obstetrician posite risks of minor and major neonatal complicagynecologists, one or two general practitioners, tions, excluding lethal congenital abnormalities.
and one nurse), developing local expertise in Composite morbidity outcomes were prespeciconducting audits and providing feedback (1-day fied on the basis of literature reviews and the
training),23 and improving the performance of consensus of experts from the QUARISMA rehealth professionals in monitoring indications search team (for details see Section 3 in the
for cesarean delivery and managing intrapartum Supplementary Appendix).24-27
care (1-day training). During the year after the
training period, four 3-month audit cycles were Statistical Analysis
implemented by audit committees, with the sup- The sample size was calculated to maximize
port of external facilitators who made quarterly statistical power while minimizing the number
educational outreach visits. Each cycle included of clusters.28 To account for clustering by hospifive standardized steps: the identification of wom- tal, we assumed an intraclass correlation coefen who had cesarean deliveries during the first ficient of 0.0065, estimated on the basis of the
month of each cycle; the collection of data, with number of deliveries in Quebec in the year
the use of standardized forms, regarding the man- 20062007.22 We calculated that we would have
agement of labor and delivery; the assessment by to enroll 32 hospitals, with a total of 34,848
the local audit committee, with the use of clinical expected deliveries per year, for the study to have
algorithms, of the relevance of the indications for 90% power to detect a 20% relative reduction
cesarean delivery; the formulation of recommen- with the intervention in the rate of cesarean
dations for best practices and the evaluation of deliveries, assuming a baseline rate of 23.5%, at
previous recommendations, both performed by a two-sided alpha significance level of 0.05.29
the committee; and the provision of informal and
In the primary intention-to-treat analyses, we
formal feedback to health professionals. During assessed the effect of the intervention on the
the 1-year postintervention period, health profes- rate of cesarean delivery using the multivariable
sionals in the intervention group were encour- generalized-estimating-equations extension of loaged to continue performing clinical audits, but gistic regression, with an exchangeable covariwithout supervision, in order to assess the pro- ance matrix, to account for the clustering of
grams sustainability. The mean time required by women within hospitals.30 Changes in the risk of
the audit committee members to conduct each cesarean delivery in the two study groups beaudit session, to formulate and produce recom- tween the 1-year baseline (preintervention) peri1712

od and the 1-year postintervention period were

compared with the use of an adjusted odds ratio
(with 95% confidence intervals) for the interaction between group (intervention vs. control)
and time period (postintervention vs. baseline).28
The adjusted odds ratio for interaction was estimated with the use of data on women who delivered during the baseline period or the postintervention period and measured the intervention effect
with the difference-in-differences approach,31,32
which was adapted for generalized-estimatingequations analyses of clustered binary outcomes
(see Section 6 in the Supplementary Appendix).28
Two-tailed P values of less than 0.05 were considered to indicate statistical significance.
All primary analyses included adjustments for
prespecified potential risk factors associated with
cesarean delivery according to individual hospital
and patient. These included adjustments for hospital academic status and level of care; maternal
age, parity, previous cesarean delivery, any pathologic condition during pregnancy, smoking during pregnancy, and the use of assisted reproductive technology; and the babys gestational age,
birth weight, and fetal presentation at delivery.
To conform to the intention-to-treat approach,
all women who delivered at participating hospitals were included in the analyses. Consequently,
we used random imputation (performed on the
basis of the observed distributions of the imputed variable and of highly correlated covariates) for adjustment variables for which less than
1% of the data were missing. The only characteristic for which missing data accounted for more
than 1% of the data was body-mass index before
pregnancy, for which data were missing for 27.2%
of the women in the study; data on body-mass
index were excluded from the analyses. No data
were missing for cesarean delivery or obstetrical
interventions. To assess whether the intervention effect varied according to hospital type or
level of risk associated with the pregnancy (Section 4 in the Supplementary Appendix), we tested
the corresponding three-way interactions: level
of careinterventiontime and risk levelinterventiontime. Subgroup-specific intervention effects were reported for outcomes with significant
three-way interactions (tests were two-tailed, with
P<0.05 considered to indicate statistical significance).31,32
Prespecified secondary outcomes were analyzed
by means of methods similar to those used for
the primary outcome. Analyses of obstetrical interventions and maternal and neonatal morbidity
were based on all deliveries; analyses of intrapartum maternal morbidity were restricted to women
who attempted labor. If the generalized-estimating-equations model did not converge because
there were small numbers of outcomes in some
hospitals, the intervention effect was estimated
with the use of a multivariable logistic model,
which did not account for within-hospital clustering; to correct for the resulting underestimation of the standard errors, a conservative P value
of less than 0.001 was used.30,32
Immediately after the intervention period,
adherence to the protocol was assessed in intervention hospitals through analyses of audit reports
and onsite visits. Hospitals were considered to
have adhered to the program if they met the following prespecified criteria: conduct of at least
three 3-month audit sessions annually, review of
more than 80% of eligible cesarean cases, and
formulation of recommendations and formal
feedback to health personnel in maternity units
within 2 months after each audit cycle. Intervention hospitals that did not meet all these criteria
were excluded from the intervention group for
per-protocol analyses. All analyses were performed
with the use of SAS software, version 9.3 (SAS
Institute) by an independent team whose members were unaware of the group assignments.
R e sult s
Primary Outcome
Among the 40 eligible hospitals, 38 agreed to

participate and 32 were randomly selected for
inclusion in the trial in April 2008 (4 community,
22 regional, and 6 tertiary hospitals). Among the
184,952 women who delivered during the overall
study period, 105,351 women delivered during
the pre- or postintervention period and contributed directly to the estimation of the intervention effect. No hospital or woman was lost to
follow-up (Fig.1). Baseline characteristics were
similar among hospitals and among women, with
the exception of a marginally significant betweengroup difference in maternal parity (Table1), for
which adjustments were made in multivariable
analyses. The baseline rate of cesarean delivery
was slightly higher in the control group than in
the intervention group (23.2% vs. 22.5%), and the
postintervention rate increased to 23.5% in the

1713
The
32 Hospitals underwent randomization at end

of baseline (preintervention) period, with
stratification according to hospital type
16 Were assigned to intervention group
16 Were assigned to control group
Implementation (6 mo) and

intervention with supervision (1 yr)
No intervention
16 Hospitals were included in follow-up

analysis
84,227 Women were included
in analysis (none lost to
follow-up)
24,388 Women (24,823 newborns) were included in
baseline period (1 yr)
36,355 Women (37,045 newborns) were included
in intervention period
(1.5 yr)
postintervention period
(1 yr)
16 Hospitals were included in follow-up

analysis
100,725 Women were included
in analysis (none lost to
follow-up)
baseline period (1 yr)
43,246 Women (43,942 newborns) were included
in intervention period
(1.5 yr)
postintervention period
(1 yr)
Figure 1. Randomization, Intervention, and Follow-up.
of
m e dic i n e
whereas no significant effect was observed among

women with high-risk pregnancies (P=0.35). In
both groups, previous cesarean delivery, noncephalic presentation, prolonged labor, and an abnormal pattern in fetal heart rate were the leading indications for cesarean delivery (Table S1 in
the Supplementary Appendix). The reduction in
the rate of cesarean delivery was driven mostly
by the effect of the intervention on indications
for elective repeat cesarean deliveries and cesarean deliveries performed after prolonged labor
(Table S1 in the Supplementary Appendix).
Among the 16 hospitals in the intervention
group, 12 (75%) met the prespecified criteria for
adherence to the protocol. The main reason for
nonadherence was the absence of formal feedback provided by the audit committee to local
health professionals. The per-protocol analysis,
which excluded the 4 nonadherent intervention
hospitals, yielded a more marked intervention effect than the intention-to-treat analysis (adjusted
odds ratio, 0.82; 95% CI, 0.75 to 0.89; P<0.001;
adjusted risk difference, 3.4%; 95% CI, 4.8 to
2.0) (Table2); no significant heterogeneity across
hospitals was found (P=0.38). Center-specific
results are shown in Section 5 in the Supplementary Appendix.
Secondary Outcomes
control group but decreased to 21.8% in the intervention group (Table2).

In a between-group comparison of the change
from the preintervention period to the postintervention period, there was significant but small
reduction in the rate of cesarean delivery in the
intervention group as compared with the control
group, with an adjusted odds ratio of 0.90 (95%
confidence interval [CI], 0.80 to 0.99; P=0.04)
and an adjusted absolute risk difference of 1.8%
(95% CI, 3.8 to 0.2) (Table2). The intervention effect did not vary significantly across hospitals with different levels of care (P=0.86 for
the three-way interaction). In contrast, the interaction with the level of risk associated with pregnancy was significant (P=0.03). Among low-risk
pregnancies, the cesarean rate in the intervention group as compared with the control group
decreased significantly from the preintervention
period to the postintervention period (adjusted risk
difference, 1.7%; 95% CI, 3.0 to 0.3; adjusted
odds ratio, 0.80; 95% CI, 0.65 to 0.97; P=0.03),
1714
There was a significant but small difference between the intervention group and the control
group with respect to the change in the rate of
assisted vaginal delivery from the preintervention
period to the postintervention period (adjusted
odds ratio [intervention vs. control], 0.88; 95%
CI, 0.77 to 0.99; P=0.04; adjusted risk difference, 1.1%; 95% CI, 2.2 to 0.1), and although
the rate of labor induction increased in both
groups, there was a lesser increase in the intervention group (adjusted odds ratio, 0.82; 95% CI,
0.76 to 0.87; P<0.001; adjusted risk difference,
3.8%; 95% CI, 5.1 to 2.7) (Table3). Oxytocin
use during labor declined in both groups, but
the decline was greater in the control hospitals
(adjusted odds ratio, 1.16; 95% CI, 1.09 to 1.23;
P<0.001; adjusted risk difference, 3.2%; 95% CI,
1.9 to 4.6).
The intervention did not significantly affect
the risks of minor and major maternal complications (Table4). Among maternal complications
(Table S2 in the Supplementary Appendix), only
the rate of blood transfusion increased signifi-

Table 1. Baseline Characteristics of Hospitals and Patients.*

Characteristic
Intervention
Hospitals
(N=16)
Control
Patients
(N=24,388)
Hospitals
(N=16)
Patients
(N=28,698)
Hospitals
Type of hospital no. (%)
Community
1,325 (5.4)
Regional
11
16,045 (65.8)
11
803 (2.8)
Tertiary care
7,018 (28.8)
9,211 (32.1)
Academic hospital
8,977 (36.8)
16,159 (56.3)
18,684 (65.1)
Physicians per hospital

Obstetriciangynecologist
5.64.3
6.24.8
Family physician
9.48.9
7.45.3
Patients
Maternal age at delivery
Mean yr
29.45.1
29.84.9
Range no. (%)

17 yr
255 (1.0)
1834 yr
122 (0.4)
20,777 (85.2)
24,370 (84.9)
3,356 (13.8)
4,206 (14.7)
10,727 (44.0)
13,165 (45.9)
8,893 (36.5)
10,607 (37.0)
4,768 (19.6)
4,926 (17.2)
35 yr
Parity no. (%)
Gestational age at delivery no. (%)

<37 wk
3741 wk
2,069 (8.5)
1,982 (6.9)
22,269 (91.3)
26,675 (93.0)
42 wk
50 (0.2)
Previous cesarean delivery no. (%)

High-risk pregnancy no. (%)
Delivery by family physician no. (%)
41 (0.1)
2,782 (11.4)
3,306 (11.5)
12,910 (52.9)
13,981 (48.7)
9,715 (39.8)
11,805 (41.1)
23,190/24,823 (93.4)
27,285/29,107 (93.7)
1,436/24,823 (5.8)
1,522/29,107 (5.2)
197/24,823 (0.8)
300/29,107 (1.0)
Presentation of infant no./total no. (%)

Cephalic
Breech
Transverse
Neonatal birth weight no./total no. (%)
<1500 g
351/24,823 (1.4)
245/29,107 (0.8)
15002499 g
1,367/24,823 (5.5)
1,417/29,107 (4.9)
25003999 g
20,563/24,823 (82.8)
24,650/29,107 (84.7)
2,542/24,823 (10.2)
2,79/29,1075 (9.6)
4000 g
Stillbirths no./total no. (%)
121/24,823 (0.5)
109/29,107 (0.4)
* Plusminus values are means SD. There were no significant between-group differences at baseline except with regard to parity.
Percentages may not sum to 100 because of rounding.
P<0.05 for the difference between groups. The P value was calculated by means of a univariate model with the use of generalized estimating
equations in which the structure for patient characteristics was exchangeable or independent.
A pregnancy was considered to be low risk if the woman gave birth to a single baby in cephalic presentation, had not used assisted reproductive technology, was between 18 and 39 years of age, had a body-mass index before pregnancy between 17 and 29, had no prior cesarean
delivery, no prior or current stillbirth, no transfer to another hospital during preganancy, and no other pathologic condition or complication
during the current pregnancy or a prior pregnancy, and if the gestational age was between 37 and 42 weeks. A pregnancy was considered to
be at risk if any of these conditions was not met. See Section 4 of the Supplementary Appendix for further details.

1715
1716
3669 (21.8)
3268 (20.2)
16,144
1.6
2.4
14,717
6671 (23.2)
28,698
5415 (38.7)
13,981
1256 (8.5)
6767 (23.5)
28,781
5595 (35.5)
15,762
1172 (9.0)
13,019
6767 (23.5)
0.3
3.2
0.5
0.3
1.9 (3.0 to 0.7)
0.8 (0.8 to 2.4)
1.3 (2.3 to 0.4)
0.9 (1.9 to 0.1)
3.4 (4.8 to 2.0)
0.9 (3.1 to 1.1)
1.7 (3.0 to 0.3)
1.8 (3.8 to 0.2)
0.82 (0.75 to 0.89)
0.96 (0.87 to 1.05)
0.80 (0.65 to 0.97)
0.90 (0.80 to 0.99)
Adjusted
Odds Ratio
(95% CI)
<0.001
0.35
0.03
0.04
P Value
* The unadjusted crude difference in rate change was calculated as follows: (postintervention rate baseline rate in intervention group) (postintervention rate baseline rate in control
group).
The adjusted absolute risk difference represents adjusted differences between group-specific changes over time and was estimated with the use of the generalized-estimating-equations
(GEE) model (see Section 5 in the Supplementary Appendix).
The adjusted odds ratios for the interaction between groups (intervention vs. control) and time (postintervention period vs. baseline period) were estimated with the use of the GEE
model.
In the GEE model, P values of less than 0.05 were considered to indicate statistical significance, and P values of less than 0.06 were considered to indicate marginal significance.
Subgroup-specific effects were reported when a significant interaction with the hospital type or the pregnancy risk level was detected.
A logistic model was used because the calculations for the GEE model did not converge. For this model, P values of less than 0.001 were considered to indicate statistical significance
and P values of less than 0.003 were considered to indicate marginal significance
For the per-protocol analysis, four hospitals with a low level of adherence to the protocol were excluded from the intervention group.
Cesarean delivery
no. (%)
16,802
4365 (32.5)
13,417
0.9
6671 (23.2)
Adjusted Absolute
Risk Difference
(95% CI)
Effect of Intervention
of
Total no.
4513 (35.0)
12,910
10,067
763 (7.6)
0.7
percent
Postintervention
(N=28,781) Difference
number (percent)
Baseline
(N=28,698)
Control Group
Crude Difference
in Rate Change
(95% CI)*
Per-protocol analysis
Cesarean delivery
no. (%)
Total no.
High
11,478
971 (8.5)
Cesarean delivery
no. (%)
5128 (21.8)
percent
number (percent)
5484 (22.5)
Difference
PostBaseline
intervention
(N=24,388) (N=23,484)
Intervention Group
Total no.
Low
Risk level of pregnancy
Cesarean delivery
no. (%)
Intention-to-treat analysis
Factor
Table 2. Rates of Cesarean Delivery.
The
m e dic i n e

7,652 (35.7)
14,416 (67.2) 14,004 (67.9)
3,762 (17.5)
Use of oxytocin
during labor
Epidural analgesia
Episiotomy
3.2
0.7
5.6
1.0
1.0
3.6
5.6
0.1
percent
7,872 (27.4)
3,907 (13.6)
7,572 (30.4)
2,605 (10.5)
2,860 (11.5)
24,874
4,777 (19.1)
3,871 (15.6)
18,364 (73.5) 18,339 (73.7)
9,932 (39.7)
2,574 (10.3)
2,970 (11.9)
24,997
13,495 (47.0) 14,534 (50.5)
5,235 (18.2)
3,701 (12.9)
number (percent)
3.5
0.2
9.3
0.2
0.4
3.5
9.2
0.7
percent
Difference
0.3
(0.6 to 1.3)
0.5
(0.7 to 1.7)
3.7
(2.5 to 4.9)
1.2
(2.0 to 0.4)
0.5
(1.4 to 0.3)
0.1
(1.1 to 1.3)
3.5
(4.5 to 2.5)
0.5
(1.3 to 0.3)
Crude Difference
in Rate Change
(95% CI)*
0.1
(2.0 to 2.7)
0.4
(2.3 to 2.9)
3.2
(1.9 to 4.6)
1.1
(2.2 to 0.1)
0.9
(2.1 to 0.3)
0.5
(4.4 to 5.0)
3.8
(5.1 to 2.7)
1.0
(3.2 to 2.0)
Adjusted
Absolute Risk
Difference
(95% CI)
1.01
(0.85 to 1.21)
1.02
(0.89 to 1.17)
1.16
(1.09 to 1.23)
0.88
(0.77 to 0.99)
0.91
(0.80 to 1.03)
1.02
(0.84 to 1.22)
0.82
(0.76 to 0.87)
0.92
(0.74 to 1.13)
Adjusted
Odds Ratio
(95% CI)
0.87
0.75
<0.001
0.04
0.14
0.87
<0.001
0.42
P Value
* The unadjusted crude difference in rate change was calculated as follows: (postintervention rate baseline rate in intervention group) (postintervention rate baseline rate in control
group).
(GEE) model (see Section 5 in the Supplementary Appendix).
The adjusted odds ratios for the interaction between groups (intervention vs. control) and time (postintervention period vs. baseline) were estimated with the use of the GEE model.
A logistic model was used to calculate the values for the crude difference in rate change for high-risk pregnancies because the calculations for the GEE model did not converge.
According to the GEE model, P values of less than 0.05 were considered to indicate statistical significance (for the logistic model, P<0.001 was considered to indicate significance), and
P values of less than 0.06 were considered to indicate marginal significance (for the logistic model, P<0.003 was considered to indicate marginal significance). Subgroup-specific effects
were reported when a significant interaction with the hospital type or the pregnancy risk level was detected.
2,953 (14.3)
6,205 (30.1)
2,223 (10.8)
2,535 (11.8)
Assisted vaginal
delivery
2,256 (10.9)
2,545 (11.9)
20,612
Intrapartum
cesarean delivery
Total no.
21,449
11,563 (47.4) 11,972 (51.0)
Artificial rupture
of membranes
Women who attempted

labor
4,345 (17.8)
Pharmacologic
induction of
labor
5,501 (23.4)
2,939 (12.1)
2,872 (12.2)
number (percent)
Difference
Baseline
(N=28,698)
Postintervention
(N=28,781)
Postintervention
(N=23,484)
Baseline
(N=24,388)
Control Group
Intervention Group
Planned cesarean
delivery
All deliveries
Intervention
Table 3. Rates of Obstetrical Interventions Other Than Unplanned Cesarean Delivery.

1717
The
cantly in the intervention group relative to the

control group (adjusted odds ratio, 1.70; 95% CI,
1.18 to 2.43; P=0.004).
Minor neonatal morbidity increased in both
groups (Table4), but the increases were smaller
in the intervention group (adjusted odds ratio,
0.88; 95% CI, 0.82 to 0.94; P<0.001; adjusted risk
difference, 1.7%; 95% CI, 2.6 to 0.9). Major
neonatal morbidity decreased significantly in
the intervention group as compared with the
control group (adjusted odds ratio, 0.81; 95% CI,
0.66 to 0.98; P=0.03; adjusted risk difference,
0.7%; 95% CI, 1.3 to 0.1) (Table S4 in the
Supplementary Appendix); effects included small
absolute reductions in major trauma (adjusted
risk difference, 0.23%; 95% CI, 0.40 to 0.01;
P=0.046), the use of invasive mechanical ventilation (adjusted risk difference, 0.38%; 95% CI,
0.60 to 0.09; P=0.01); and intrapartum and
neonatal deaths (adjusted risk difference, 0.06%;
95% CI, 0.08 to 0.03; P<0.001). The effect of
the intervention on major neonatal morbidity remained significant after exclusion of preterm
births (adjusted odds ratio, 0.82; 95% CI, 0.70 to
0.96; P=0.02) and appeared to be similar in women with low-risk pregnancies and those with highrisk pregnancies (Table S5 in the Supplementary
Appendix), but the effect was not significant in
women with low-risk pregnancies (P=0.11).
Discussion
This multifaceted intervention, which involved onsite professional training in evidence-based management of labor and delivery and was designed to
promote clinical audits, feedback, and implementation of best practices, led to a statistically significant but clinically small reduction in the rate
of cesarean deliveries. The reduction was observed
among women with low-risk pregnancies but not
among those with high-risk pregnancies.
Furthermore, the intervention was associated
with a significant reduction in minor and major
neonatal morbidity among babies born to women
with low-risk pregnancies and among those born
to women with high-risk pregnancies. This result may reflect improvements in the standard of
care implemented in individual hospitals in the
intervention group. However, these results must
be interpreted with caution because of an unexpected increase in neonatal morbidity in the control group, which was presumably due to random
1718
of
m e dic i n e
variation. Overall, these results suggest that the

QUARISMA program resulted in a significant but
small reduction in the total cesarean delivery rate,
without increasing neonatal and maternal morbidity and mortality.
Among 10 prior studies randomized and
nonrandomized that assessed the effects of
similar interventions targeting health care providers (obtaining second opinions, conducting
audits with feedback, and conducting peer reviews), 3 showed significant reductions in rates of
cesarean delivery.33 However, these results were
ambiguous, since only 1 of the 4 randomized
trials showed a significant, albeit small, reduction (adjusted risk difference, 1.9%).21,33 Our
trial yielded very similar results to that trial and
confirmed the benefits of a multifaceted strategy
involving audits and feedback and targeting health
care providers, as suggested in previous nonrandomized studies and systematic reviews.17-21,33-40
Our trial also had one of the largest samples,
including more than 65% of all deliveries in
Quebec province during the study period. In addition, our results indicated that the reduction in
the rate of cesarean delivery was driven by the
effect of the intervention in low-risk pregnancies.
The QUARISMA program was designed to allow health professionals to assess care relative
to operational standards (algorithms), to detect
cases in which care could have been improved
and an unnecessary cesarean delivery avoided, and
to standardize clinical practice. The interventions
in the trial included identification of opinion
leaders, the use of onsite training, and the introduction of standardized internal clinical audits
and feedback. The safe reduction, albeit modest,
in the rates of cesarean delivery observed in this
trial and the moderate efforts required to maintain
the program (approximately 2 days per 3-month
cycle to conduct an audit session, develop recommendations, provide feedback, and review the
implementation of the recommendations) suggest that a similar intervention may be beneficial in other countries or regions in which the
rates of cesarean delivery are similar or higher.
Our study had some limitations. Since hospitals were the unit of randomization, and the
number of deliveries varied across hospitals, there
were differences in the distribution of certain
hospital characteristics across groups at baseline.
These differences were adjusted a priori in multivariable analyses. Furthermore, the intervention

1172 (4.7)
Major morbidity
1070 (4.5)
4261 (17.8)
23,902
167 (0.71)
3576 (15.2)
0.2
2.0
0.05
1.7
percent
29,211
141 (0.49)
1,018 (3.5)
1,156 (4.0)
3947 (13.6) 5002 (17.1)
29,107
138 (0.48)
3869 (13.5) 4244 (14.7)
number (percent)
0.5
3.6
0.01
1.3
percent
0.3 (1.2 to 1.8)
Adjusted Absolute
Risk Difference
(95% CI)
0.7 (1.2 to 0.2)
1.6 (2.5 to 0.7)
0.7 (1.3 to 0.1)
1.7 (2.6 to 0.9)
0.81 (0.66 to 0.98)
0.88 (0.82 to 0.94)
1.06 (0.77 to 1.48)
1.02 (0.91 to 1.15)
Adjusted
Odds Ratio
(95% CI)
0.04 (0.14 to 0.23) 0.03 (0.11 to 0.23)
0.5 (0.4 to 1.3)
Crude Difference
in Rate Change
(95% CI)
0.03
<0.001
0.71
0.76
P Value
* Events that determined minor maternal morbidity included blood transfusion, perineal tear (grade 34), puerperal infection or sepsis, gastrointestinal complications, complications
from analgesia, postpartum hospital stay of 7 days or more, admission to the intensive care unit, and readmission to the hospital. Events that determined major maternal morbidity included maternal death, hysterectomy, symptomatic uterine rupture, thromboembolic disease, and injury to internal organs. Events that determined minor neonatal morbidity included
cardiopulmonary morbidity, an Apgar score between 4 and 6 at 5 minutes after birth, moderate acidosis, minor trauma, noninvasive mechanical ventilation, blood transfusion, and neonatal infection or sepsis. Events that determined major neonatal morbidity included intrapartum or neonatal death, an Apgar score of less than 4 at 5 minutes after birth, major acidosis, major trauma, intraventricular hemorrhage, seizure, neurologic damages, invasive mechanical ventilation, necrotizing enterocolitis, and hypoxicischemic encephalopathy. For complete definitions of minor and major maternal and fetal morbidity, see Section 3 in the Supplementary Appendix.
The unadjusted crude difference in rate change was calculated as follows: (postintervention rate baseline rate in intervention group) (postintervention rate baseline rate in control
group).
(GEE) model (see Appendix 5 in the Supplementary Appendix).
The adjusted odds ratios for the interaction between groups (intervention vs. control) and time (postintervention period vs. baseline) were estimated with the use of the GEE model.
Included are infants born at a gestational age of at least 24 weeks and with a birth weight of at least 500 g at delivery.
According to the GEE model, P values of less than 0.05 were considered to indicate statistical significance, and P values of less than 0.06 were considered to indicate marginal significance. Subgroup-specific effects were reported when a significant interaction with the hospital type or the pregnancy risk level was detected.
3936 (15.9)
Total no. of births
Minor morbidity
24,823
161 (0.66)
Major morbidity
Composite risk of neonatal

morbidity
3293 (13.5)
Control Group
PostPost
intervention
Baseline intervention
(N=23,484) Difference (N=28,698) (N=28,781) Difference
number (percent)
Baseline
(N=24,388)
Intervention Group
Minor morbidity
Composite risk of maternal

morbidity
Factor
Table 4. Maternal and Neonatal Morbidity.*

1719
The
of
m e dic i n e
was not fully implemented at four intervention vention significantly reduced the rate of cesarean
hospitals. Finally, because we tested a complex, delivery among women with low-risk pregnancies
multifaceted intervention, it is not possible to de- but not among those with high-risk pregnancies.
termine which of its components were primarily
Supported by grants (200702MCT-171307-RFA-CFCF-153236
and MOP 81275) from the Canadian Institutes of Health Reresponsible for the observed effect.
search.
In summary, a program in which audits and
Disclosure forms provided by the authors are available with
best practices were implemented resulted in a the full text of this article at NEJM.org.
We thank all the medical and administrative staff at the 32
significant but small reduction in the rate of
participating hospitals for their contributions to this trial and the
cesarean deliveries without increasing neonatal data collectors, research nurses, and medical archivists in each
and maternal morbidity and mortality. The inter- hospital whose assistance helped to ensure the quality of the data.
References
1. Martin JA, Hamilton BE, Sutton PD, et
al. Births: final data for 2003. Natl Vital
Stat Rep 2005;54:1-116.
2. Thomas J, Paranjothy S. Royal College
of Obstetricians and Gynecologists Clinical Effectiveness Support Unit:national
sentinel caesarean section audit report.
London:RCOG Press, 2001 (https://w ww
.rcog.org.uk/globalassets/documents/
guidelines/research--audit/nscs_audit
.pdf).
3. Blondel B, Lelong N, Kermarrec M,
Goffinet F. Trends in perinatal health in
France between 1995 and 2010: results
from the National Perinatal Surveys. J Gynecol Obstet Biol Reprod (Paris) 2012;41:
151-66. (In French.)
4. Canadian perinatal health report,
2008. Ottawa:Public Health Agency of
Canada, 2008 (http://www.phac-aspc.gc
.ca/publicat/2008/cphr-rspc/index-eng
.php).
5. Health system performance: health
indicators. Catalogue no. 82-221-XIE. Vol.
2005, No. 3. Ottawa:Statistics Canada,
2005 (http://www.statcan.gc.ca/pub/82221-x/82-221-x2005002-eng.htm).
6. Giving birth in Canada: regional
trends from 2001-2002 to 2005-2006. Ottawa:Canadian Institute for Health Information, 2007 (https://secure.cihi.ca/free_
products/childbirth_aib_070725_e.pdf).
7. National Collaborating Centre for
Womens and Childrens Health. Caesarean section: clinical guideline. London:
RCOG Press, 2004.
8. Liu S, Heaman M, Joseph KS, et al.
Risk of maternal postpartum readmission associated with mode of delivery.
Obstet Gynecol 2005;105:836-42.
9. Hall MH, Bewley S. Maternal mortality and mode of delivery. Lancet 1999;354:
776.
10. Alexander S, Wildman K, Zhang W,
Langer M, Vutuc C, Lindmark G. Maternal
health outcomes in Europe. Eur J Obstet
Gynecol Reprod Biol 2003;
111:
Suppl 1:
S78-S87.
11. Lydon-Rochelle M, Holt VL, Martin
DP, Easterling TR. Association between
method of delivery and maternal rehospitalization. JAMA 2000;283:2411-6.
1720
12. Allen VM, OConnell CM, Liston RM,

Baskett TF. Maternal morbidity associated with cesarean delivery without labor
compared with spontaneous onset of labor at term. Obstet Gynecol 2003;102:47782.
13. Zanardo V, Simbi AK, Franzoi M, Sold G, Salvadori A, Trevisanuto D. Neonatal respiratory morbidity risk and mode of
delivery at term: influence of timing of
elective caesarean delivery. Acta Paediatr
2004;93:643-7.
14. Levine EM, Ghai V, Barton JJ, Strom
CM. Mode of delivery and risk of respiratory diseases in newborns. Obstet Gynecol 2001;97:439-42.
15. Giving birth in Canada: the costs. Ottawa:Canadian Institute for Health Information, 2007 (https://secure.cihi.ca/free_
products/Costs_Report_06_Eng.pdf).
16. Rowe AK, de Savigny D, Lanata CF,
Victora CG. How can we achieve and
maintain high-quality performance of
health workers in low-resource settings?
Lancet 2005;366:1026-35.
17. Chaillet N, Dub E, Dugas M, et al.
Evidence-based strategies for implementing guidelines in obstetrics: a systematic
review. Obstet Gynecol 2006;108:1234-45.
18. Chaillet N, Dumont A. Evidencebased strategies for reducing cesarean
section rates: a meta-analysis. Birth 2007;
34:53-64.
19. Lomas J, Anderson GM, DomnickPierre K, Vayda E, Enkin MW, Hannah WJ.
Do practice guidelines guide practice?
The effect of a consensus statement on
the practice of physicians. N Engl J Med
1989;321:1306-11.
20. Lomas J, Enkin M, Anderson GM,
Hannah WJ, Vayda E, Singer J. Opinion
leaders vs audit and feedback to implement practice guidelines: delivery after
previous cesarean section. JAMA 1991;
265:2202-7.
21. Althabe F, Belizn JM, Villar J, et al.
Mandatory second opinion to reduce rates
of unnecessary caesarean sections in Latin America: a cluster randomised controlled trial. Lancet 2004;363:1934-40.
22. Ministry of Health and Social Services (Quebec). Administrative database
MED-ECHO (Quebecs hospital discharges). January 2008.

23. Beyond the numbers: reviewing maternal deaths and complications to make
pregnancy safer. Geneva:World Health
Organization, 2004 (http://www.who.int/
maternal_child_adolescent/documents/
9241591838/en).
24. McMahon MJ, Luther ER, Bowes WA
Jr, Olshan AF. Comparison of a trial of
labor with an elective second cesarean
section. N Engl J Med 1996;335:689-95.
25. Hannah ME, Hannah WJ, Hewson
SA, Hodnett ED, Saigal S, Willan AR.
Planned caesarean section versus planned
vaginal birth for breech presentation at
term: a randomised multicentre trial.
Lancet 2000;356:1375-83.
26. Landon MB, Hauth JC, Leveno KJ, et
al. Maternal and perinatal outcomes associated with a trial of labor after prior
cesarean delivery. N Engl J Med 2004;351:
2581-9.
27. American College of Obstetricians
and Gynecologists. ACOG practice bulletin: vaginal birth after previous cesarean
delivery. Number 5, July 1999 (replaces
practice bulletin number 2, October
1998): clinical management guidelines
for obstetrician-gynecologists. Int J Gynaecol Obstet 1999;66:197-204.
28. Donner A, Klar N. Design and analysis of cluster randomization trials in
health research. New York:Oxford University Press, 2000.
29. Pinol APY, Piaggio G. ACluster: design and analysis of cluster randomization trials. 2nd ed. Geneva:World Health
Organization, 2000.
30. Zeger SL, Liang KY, Albert PS. Models
for longitudinal data: a generalized estimating equation approach. Biometrics
1988;44:1049-60.
31. Abrahamowicz M, Beauchamp ME,
Fournier P, Dumont A. Evidence of subgroup-specific treatment effect in the absence of an overall effect: is there really a
contradiction? Pharmacoepidemiol Drug
Saf 2013;22:1178-88.
32. Dumont A, Fournier P, Abrahamowicz M, Traor M, Haddad S, Fraser WD.
Quality of care, risk management, and

technology in obstetrics to reduce hospi- SM. Using the medical audit cycle to retal-based maternal mortality in Senegal duce cesarean section rates. Am J Obstet
and Mali (QUARITE): a cluster-ran- Gynecol 1996;174:199-205.
domised trial. Lancet 2013;382:146-57.
36. Bickell NA, Zdeb MS, Applegate MS,
33. Khunpradit S, Tavender E, Lumbiga- Roohan PJ, Sui AL. Effect of external peer
non P, Laopaiboon M, Wasiak J, Gruen review on cesarean delivery rates: a stateRL. Non-clinical interventions for reduc- wide program. Obstet Gynecol 1996;87:
ing unnecessary caesarean section. Co- 664-7.
chrane Database Syst Rev 2011;
6: 37. Main EK. Reducing cesarean birth
CD005528.
rates with data-driven quality improve34. Liang WH, Yuan CC, Hung JH, et al. ment activities. Pediatrics 1999;103:Suppl
Effect of peer review and trial of labor on E:374-83.
lowering cesarean section rates. J Chin 38. Davis D, OBrien MA, Freemantle N,
Med Assoc 2004;67:281-6.
Wolf FM, Mazmanian P, Taylor-Vaisey A.
35. Robson MS, Scudamore IW, Walsh Impact of formal continuing medical
education: do conferences, workshops,

rounds, and other traditional continuing
education activities change physician behavior or health care outcomes? JAMA
1999;282:867-74.
39. Lagrew DC Jr, Morgan MA. Decreasing the cesarean section rate in a private
hospital: success without mandated clinical changes. Am J Obstet Gynecol 1996;
174:184-91.
40. Myers SA, Gleicher N. A successful
program to lower cesarean-section rates.
N Engl J Med 1988;319:1511-6.
Copyright 2015 Massachusetts Medical Society.

1721

A Cluster-Randomized Trial To Reduce Cesarean Delivery Rates in Quebec

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

A Cluster-Randomized Trial To Reduce Cesarean Delivery Rates in Quebec

Uploaded by

Copyright:

Available Formats

The

A Cluster-Randomized Trial to Reduce

*A complete list of the members of the

N Engl J Med 2015;372:1710-21.

Copyright 2015 Massachusetts Medical Society.

The New England Journal of Medicine

A Trial to Reduce Cesarean Delivery R ates

ates of cesarean delivery are high

We conducted the QUARISMA (Quality of Care,

ment programs specifically designed to reduce

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

A Trial to Reduce Cesarean Delivery R ates

od and the 1-year postintervention period were

Among the 40 eligible hospitals, 38 agreed to

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

32 Hospitals underwent randomization at end

16 Were assigned to intervention group

16 Were assigned to control group

Implementation (6 mo) and

16 Hospitals were included in follow-up

16 Hospitals were included in follow-up

Figure 1. Randomization, Intervention, and Follow-up.

whereas no significant effect was observed among

control group but decreased to 21.8% in the intervention group (Table2).

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

A Trial to Reduce Cesarean Delivery R ates

Table 1. Baseline Characteristics of Hospitals and Patients.*

Physicians per hospital

Range no. (%)

Gestational age at delivery no. (%)

Previous cesarean delivery no. (%)

Presentation of infant no./total no. (%)

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

1.9 (3.0 to 0.7)

0.8 (0.8 to 2.4)

1.3 (2.3 to 0.4)

0.9 (1.9 to 0.1)

3.4 (4.8 to 2.0)

0.9 (3.1 to 1.1)

1.7 (3.0 to 0.3)

1.8 (3.8 to 0.2)

0.82 (0.75 to 0.89)

0.96 (0.87 to 1.05)

0.80 (0.65 to 0.97)

0.90 (0.80 to 0.99)

Risk level of pregnancy

Table 2. Rates of Cesarean Delivery.

n engl j med 372;18nejm.org April 30, 2015

The New England Journal of Medicine

14,416 (67.2) 14,004 (67.9)

18,364 (73.5) 18,339 (73.7)

13,495 (47.0) 14,534 (50.5)

11,563 (47.4) 11,972 (51.0)

Women who attempted

Table 3. Rates of Obstetrical Interventions Other Than Unplanned Cesarean Delivery.

A Trial to Reduce Cesarean Delivery R ates

n engl j med 372;18nejm.org April 30, 2015