Professional Documents
Culture Documents
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 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
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.
CONCLUSIONS
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
Me thods
Hospitals and Participants
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
n e w e ng l a n d j o u r na l
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
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
1713
The
n e w e ng l a n d j o u r na l
No intervention
of
m e dic i n e
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-
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)
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
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. (%)
2,069 (8.5)
1,982 (6.9)
22,269 (91.3)
26,675 (93.0)
42 wk
50 (0.2)
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)
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
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)*
n e w e ng l a n d j o u r na l
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
Cesarean delivery
no. (%)
Intention-to-treat analysis
Factor
The
m e dic i n e
7,652 (35.7)
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)
9,932 (39.7)
2,574 (10.3)
2,970 (11.9)
24,997
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)
Effect of Intervention
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).
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) 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
Artificial rupture
of membranes
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
1717
The
n e w e ng l a n d j o u r na l
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
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)
29,107
138 (0.48)
number (percent)
0.5
3.6
0.01
1.3
percent
Adjusted Absolute
Risk Difference
(95% CI)
Adjusted
Odds Ratio
(95% CI)
Effect of Intervention
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).
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 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)
Minor morbidity
24,823
161 (0.66)
Major 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
Factor
1719
The
n e w e ng l a n d j o u r na l
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.
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