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An Attempt to Manage
Variation in Obstetrical Practice
Stephen C. Schoenbaum
The work presented here is not research; rather, it is clinical program
evaluation and management. Compared to the conduct of a controlled clinical
trial, this approach is awkward. It is, however, a practical attempt to mea-
sure variation in clinical practice and to manage the apparent variation. The
scenario below is a specific example from which it is possible to draw more
general lessons about outcomes measurement and management.
THE HARVARD COMMUNITY HEALTH PLAN EXPERIENCE
Several years ago, Donald Berwick, Vice-President for Quality of Care
Measurement at Harvard Community Health Plan (HCHP), decided that as
part of his quality measurement activities it would be important to develop
data bases on common clinical activities. The data bases would contain
information on outcomes of interest. They would also contain some additional
variables describing the population and processes of care. Dr. Berwick's
hopes were that these data bases could be used to analyze outcomes in
relation to process and that the data could be adjusted for population differ-
ences so that data from different sites within HCHP and external data might
be compared.
THE CHOICE OF OBSTETRICAL CARE
Health maintenance organizations (HMOs) have large numbers of young
members of childbearing age, and it was logical that the first HCHP data
base should be one on obstetrical care. The Health Centers Division of
HCHP is currently a 275,000-member staff model HMO with care delivered
in 10 centers around the Boston area. In 1986-1987, the first year of the
190
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APPLICATION TO CLINICAL PRACTICE
TABLE 1 HCHP Deliveries July 1, 1986 - June 30, 1987
191
Health Center/Hospital Used
Deliveries 1/A 2/B 3/A 4/B 5/A 6/C 7/A 8/A
Number 785 627 489 5 10 497 1 80 376 118
Total per hospital
A 2265
B 1 137
C 180
obstetrical data base, there were eight health centers, seven of which used
one of two Harvard teaching hospitals with large obstetrical services (Table
19. To obtain data for the period July 1, 1986 through June 30, 1987,
HCHP staff reviewed and abstracted the hospital and ambulatory records of
all HCHP members who had a delivery.
Table 1 shows the number of deliveries among members of each health
center and the hospital (A, B. or C) used by each center. Only center 6 used
a nonteaching hospital distant from Boston; because it had a relatively small
number of deliveries, I will not consider it further. The aggregate number
of HCHP deliveries in hospitals A and B is substantial, even though in both
instances, HCHP deliveries were less than one-third of the total deliveries
in each hospital.
VARIATIONS IN PRACTICE BETWEEN TWO HOSPITALS
Hospitals A and B have fully developed academic departments of obstet-
rics and gynecology headed by full professors at Harvard Medical School.
They are believed to have comparable outcomes in terms of neonatal mortality
for comparable populations, although hospital A serves as a regional perinatal
center, takes care of more referred high-risk obstetrical patients, and has a
much larger and more sophisticated neonatal intensive-care unit (ICU). Neither
HCHP, the hospitals themselves, nor the state's department of vital statistics
can provide appropriate, comparable neonatal mortality figures.
Only in rare instances of extremely high-risk mothers does HCHP dis-
tribute patients to hospital A because it can provide more intensive care.
Almost always, the hospital of delivery is determined by the health center
in which the member receives her prenatal care. In 1986-1987, each HCHP
health center had its own department of obstetrics and gynecology; that is,
each center had its own chief and staff, and each arranged its own coverage
schedule. To the extent that cross-center coordination of schedules and
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
TABLE 2 HCHP Deliveries July 1, 1986 - June 30, 1987, by Type of
Delivery and Health Center and Hospital Used
Deliveries (%) per Health Center/Hospital Used
Type of Delivery 1/A 2/B 3/A 4/B S/A 7/A 8/A
Spontaneous vaginal 57 76 59 78 57 55 59
Cesarear~ section 27 20 22 19 26 28 21
Forceps 15 1 18 1 15 16 18
Vaginal birth after
cesarean section
1 3 1 2 2 1 2
TABLE 3 HCHP Deliveries July 1, 1986 -
June 30, 1987, by Type of Delivery
Deliveries (~o) per Hospital
Type of Delivery
A B
Spontaneous vaginal 57 77
Cesarean section 26 19
Forceps 16 1
Vaginal birth after
cesarean section 1 3
combined educational sessions occurred at all, they occurred along the lines
of hospital use.
Table 2 shows one of the initial analyses from the obstetrical data base.
Type of delivery was the first object of attention, and it is the focus of
subsequent attempts at intervention. Substantial variation is noted in the
percentage of women in the various centers who had a spontaneous (nonoperative)
vaginal delivery. This is due to higher rates of cesarean section and forceps
deliveries in some centers than others.
The lowest rates of operative deliveries are for health centers using hos-
pital B (see Table 3~. The occurrence of forceps deliveries is much lower in
the hospital with the lower cesarean section rate; this is an unexpected
finding, since one might predict that in order to avoid a cesarean section for
problems such as cephalopelvic disproportion, the physician would have to
extract the baby with forceps. In addition, vaginal birth after cesarean
section was somewhat more commonly performed in hospital B. The difference
in rates between the two hospitals is even more dramatic if one considers
only those women who are primiparas that is, those having their first
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APPLICATION TO CLINICAL PRACTICE
193
delivery. In hospital A, 29 percent of primiparas had a cesarean section vs.
22 percent in hospital B. In hospital A, an additional 24 percent of primiparas
had a forceps delivery vs. only 2 percent in hospital B. All of these findings
suggested to us that practice style might differ significantly between the
two hospitals. There are no "right" rates of operative delivery, but we
believe that the differences should not be so great.
POSSIBLE CAUSES OF THE VARIATIONS
A preliminary version of these data was shown to the center-based chiefs
of obstetrics. They reasoned that there are differences between health centers
and that, since they and their staffs were all equally competent, the differ-
ences in rates of operative deliveries must be due to differences in membership.
Table 4 highlights these differences and shows the distribution by health
center of obstetrical patients who are very young, relatively older, nonwhite,
or not married.
Although substantial center-to-center differences exist, no single charac-
teristic correlates with a high cesarean section or forceps delivery rate. A
multivariate analysis with a large number of potential confounding variables
was unable to demonstrate any important contributor to the observed varia-
tion in type of delivery by health center other than the hospital at which the
delivery occurred.
Another consideration is whether the variation in delivery rates was re-
lated to characteristics of the offspring. When the data were adjusted for
low birthweight (which is the only adverse neonatal characteristic that occurs
TABLE 4 Patient Characteristics and Types of Delivery of HCHP
Members, by Health Center and Hospital Used
Members (%) per Health Center/Hospital Used
Measure
1/A2/B3/A4/B 5/A7/A 8/A
Patient characteristic
Less than 18 3.00.71.11.9 0.53.6
years old
Over 35 11.213.518.46.1 4.75.8 6.5
years old
Nonwhite 48.624.22.67.1 9.551.9 29.0
Not married 24.()9.43.68.5 4.837.2 23.3
Type of delivery
Cesarean section 27202219 2628 21
Forceps 151181 1516 18
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
with enough frequency in this population to permit adequate analysis), the
variation in type of delivery by hospital persisted.
Cesarean section is associated with significant maternal morbidity, including
infections, increased length of stay, and higher hospitalization costs. In
recent years, despite continued increases in cesarean section rates nationwide,
it has not been possible to show a continued concomitant improvement in
neonatal outcomes. Accordingly, although little information on neonatal
outcomes in HCHP patients in hospitals A and B existed, it was reasonable
to consider operative deliveries a relatively independent outcome of obstet-
rical care.
There can be several determinants of outcome, including host (that is, the
patient), environment in which care is delivered, and the process of care
itself, the latter being within local control. We hypothesized that variation
in operative delivery rates ought to have some relationship to the process of
care, and we hypothesized that the following components of process of care
might affect type of delivery:
· Prenatal education,
· Obstetrical care (prehospital, in-hospital),
· Nursing care,
· Anesthesia care, and
· Other
In a series of interviews we tried to determine from our chiefs of obstetrics
and from others in hospitals A and B what the differences in the process of
care might be for patients in these institutions. They identified several
areas:
Location of labor and delivery suite,
· Ratio of nurse to patient in labor,
· Obstetrical policies (labor curves, forceps),
· Epidural anesthesia in labor, and
· Relationship of HCHP obstetricians to hospital obstetrics department.
We did find differences in these areas. The labor and delivery suite in
hospital A is below ground, windowless, relatively noisy, and unattractive
compared to that in hospital B. There was a nurse-to-patient ratio of 1:2 or
greater for the labor suite in hospital A, compared to a 1:1 ratio at hospital
B. In both hospitals the chairman of the department of obstetrics gave
strong guidance to clinical policy but in hospital B a graphics tool was used
to follow the progress of labor (with a strict definition of failure to progress)
and the use of forceps was frowned upon and required specific justification.
Consequently, the staff of hospital B did not get much instruction or experience
in the use of forceps and may have been less comfortable than the average
staff in using them. In contrast, a type of forceps instrument was developed
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APPLICATION TO CLINICAL PRACTICE
195
at hospital A many years ago, and there was no injunction against using
them.
Anesthesia practices also differed. In hospital A, the practice was to use
epidural analgesia for most patients in labor (about 70 percent) and not to
reduce use of it prior to delivery. In hospital B. only about half the patients
received epidural analgesia in labor, and the practice was to keep use of it
light, especially as labor progressed.
The obstetrical staff also differed. The HCHP obstetricians in hospital B
had, for the most part, trained there and were considered "insiders," whereas
the HCHP obstetricians in hospital A tended to have trained elsewhere and
were more likely to be considered "outsiders." HCHP obstetricians in hos-
pital A had poorer morale than HCHP obstetricians in hospital B. The
chairman of obstetrics in hospital A had expressed concern about the coor-
dination of care for HCHP patients by HCHP obstetricians. Finally, residents
interacted closely and directly with HCHP obstetricians for virtually all
HCHP patients in hospital B. but only for the highest risk or most complicated
patients in hospital A.
One thing that did not differ between the two hospitals was patient satisfaction
(except for the rating of the ambiance of the labor and delivery suite in
hospital A).
THE ATTEMPT TO CHANGE PROCESS OF CARE
To attempt to alter the process of care for HCHP patients in hospital A,
HCHP felt that it needed a multifaceted programmatic intervention. Such
interventions do not necessarily take the form of those that might be incor-
porated into controlled clinical trials. The first intervention was to appoint
a single Plan-wide chief of obstetrics and to arrange for him to have an
office in hospital A. The person who was appointed happened to be HCHP's
most senior and experienced center-based chief. He had been trained at
hospital B. but he had also practiced in hospital A a decade earlier and was
respected by the chairman in hospital A. He had moved back to hospital B
and had developed the departments of obstetrics in the two health centers
using hospital B.
Over the next year, the workload of the new chief was very heavy. It
included an enormous effort to recruit new obstetricians for a growing HMO
and to improve HCHP's central infertility services in response to marked
increases in demand. (In that year, Massachusetts mandated infertility benefits
of all health insurers, including in vitro fertilization services.) The new central
chief also began to work on changing the process of care in hospital A.
Several things occurred almost simultaneously. The chief, in order to
recruit successfully, convinced HCHP to increase obstetrical salaries. This,
and his successful personal interactions with subchiefs and staff, seemed to
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EFFECTf VENESS AND OUTCOMES IN HEALTH CARE
improve morale among existing obstetricians.
Three older obstetricians
using hospital A ceased obstetrical practice and devoted themselves to gynecology.
Thus, a high percentage of the persons doing obstetrics for HCHP at hospital
A became direct recruits of the chief and could be thought of as "his people."
He also recruited a senior perinatologist from the academic staff of hospital
B to work for HCHP, based primarily at hospital A. This had at least two
effects: it led the HCHP obstetricians at hospital A to realize that their
performance was being monitored more closely (which might have an effect
on issues such as continuity of care), and it provided them with an experienced
and friendly consultant who could support them in a tough decision to wait
it out with a patient rather than moving quickly to a cesarean.
The chief also began to work directly with the anesthesia staff of hospital
A. In April 1988 an agreement was reached, in the form of a memorandum
from the clinical chief of anesthesia to the entire obstetrical staff (HCHP
and others), that obstetricians could have a say in the degree of analgesia
provided to their patients in labor. The chief also worked to make nurses in
hospital A aware that HCHP obstetricians might want longer and more
forceful pushing by their patients in labor than had been the usual practice
in hospital A in the past.
PRELIMINARY RESULTS
Table 5 shows preliminary results. The burdens of obtaining data for the
obstetrical data base were sufficiently great that no additional data were
collected for deliveries between July 1987 and September 1988. Data collection
resumed in the fall of 1988, but only for a 50 percent sample of deliveries;
the data shown in Table 5, therefore, are for only a small number of patients.
They may not prove stable, and we will not have additional data, on January
TABLE 5 HCHP Deliveries in 1986-1987 and in October-December
1988, by Type of Delivery
Deliveries (%) per Hospital
A B
1986-1987 1988 1986-1987 1988
Type of Delivery (N = 2265) (N = 319) (N = 1137) (N = 143)
Spontaneous vaginal 57 68 77 76
Cesarean section 26 21 19 19
Forceps 16 9 1 1
Vaginal birth after
cesarean section 1 2 3 4
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197
TABLE 6 HCHP Deliveries For Primiparas in 1986-1987 and in October-
December 1988, by Type of Delivery
Deliveries (%) per Hospital
A
B
1986-1987 1988 1986-1987 1988
Type of Delivery (N = 1213) (N = 168) (N = 586) (N = 67)
Spontaneous vaginal 47 59 76 77
Cesarear~ section 29 25 22 22
Forceps 24 16 2 1
TABLE 7 Type of Delivery Among Candidates
for Repeat Cesarean Section at HCHP
Type of Delivery
Deliveries (%) per Year
1986-1987 1988
(N = 268) (N = 37)
Cesarean section 87 63
Vaginal birth 13 37
through March 1989, until approximately November 1989, because of a
continued backlog of work. Nevertheless, as we look at the available data,
we see an encouraging trend toward fewer operative deliveries in hospital
A; anecdotal evidence suggests that the trend is continuing.
Table 6 shows a decrease in the rate of operative deliveries in primipa-
ras, and Table 7 shows that the practice of vaginal birth after cesarean
section is also increasing at HCHP. There has been a significant contribution
from hospital A, and this, too, will lead to decreased cesarean section rates.
LESSONS
As I stated at the outset, this is not research, but rather a description of
work in progress to manage variations in practice by altering process of
care. What lessons might we derive from it?
First, the data collection process is difficult and expensive. Even though
HCHP has automated medical records for all but two centers, and thus easy
access to prenatal records, the information presented here does not come
from routinely collected data.
It is hard to collect and analyze the data for enough potential confounders
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
to satisfy doubters that demonstrated variation is not attributable just to
some unanalyzed confounding variable.
Process interventions in the real world are complex. They tend to be
different from situation to situation, institution to institution. They often do
not come directly from controlled trials, and they may take the form of
appointing a new chief, or firing an old one, or changing a reimbursement
scheme, or threatening to move one's business to another vendor or hospital.
The complex intervention leads to multiple changes rather than to the single,
sometimes unrealistically simple, changes of controlled trials.
Another lesson is that the unit of data collection and organization for
process improvement is relatively small by statistical or epidemiological
standards. This makes it hard to sort random from significant variation it
is not easy to convince caregivers or managers that there is a problem worth
working on. It also makes it harder to analyze interventions results will
not necessarily be statistically convincing, as they are in a controlled trial,
and the results will be confounded by time-trend differences in care that
would have occurred anyway.
Despite these problems, it may be important to act in the face of apparent
variation, as we did, even without the most solid data. Such action needs to
be accompanied by a commitment to watch, nonjudgmentally, what happens
over time. Some observers will undoubtedly feel we acted too fast; others
may be uncomfortable in concluding at this time that we are making a
difference.
Another instructive point from this example is that we took a very differ-
ent tack in assessing variation in cesarean section rates than we might have
taken if we had followed the appropriateness approach (as The RAND Cor-
poration did in its work on variation in surgical practices). Table 8 shows
the reasons for cesarean sections in hospitals A and B. as extracted from the
records. Although the distributions differ somewhat, over 50 percent of the
procedures are attributed either to cephalopelvic disproportion or failure to
progress, 20 percent to breech presentation, and 15 percent to fetal distress.
I believe that there is enough softness in the definitions of cephalopelvic
disproportion, failure to progress, and fetal distress that an independent
group of experts assessing only the records of patients having a cesarean
section in the two hospitals would have concluded that a similar percentage
of the cesarean sections in the hospitals was "appropriate." The depart-
ments of obstetrics in these hospitals have regular reviews of their own
cesarean sections and rarely conclude that one is inappropriate.
Accordingly, had we followed the appropriateness approach to assessing
variation in surgical practices, we might have concluded that the overall
difference in cesarean rates between these two hospitals was most likely
due to some occult underlying difference in the populations rather than to a
difference in the process of care. Although it is important to eliminate truly
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APPLICATION TO CLINICAL PRACTICE
TABLE 8 Reason For Cesarean Section
(% of Total Per Hospital)
Hospital
Reason
A B
Breech1723
Failure to progress3623
Cephalopelvic disproportion1929
Fetal distress1614
Multiple pregnancy10
Placenta previa12
Abruptio placentae21
Maternal indications21
Herpes33
Other34
TOTAL
100100
199
inappropriate procedures, some, perhaps many, procedures that in retrospect
are judged appropriate may actually be unnecessary.
A CAUTION
I would like to end on a word of caution for those who think that out-
comes measurement and management are "the way to go." It is clearly
important to assess what we are doing in medical care and to try to determine
how, in real life and real time, we can do it better. These efforts are,
however, going to be slow, difficult, and costly. There is a whole science
of program evaluation that needs to be developed and learned by providers
of health care. Experienced epidemiologists will need to be recruited to
these efforts. Journals will need to begin to report program evaluations so
that we can learn from them.
Leaders in health care will have to learn what is realistic and what is not.
There are important priorities to be set and the Effectiveness Initiative is a
step in this direction. Experts have to put their heads together to consider
what information might be obtained from routinely collectable data and
what information might be collected at a low marginal cost.
Most important, health care experts and providers will have to learn how
information, once obtained, can be used to generate process improvements.
The trick is in getting from Health Care Financing Administration mortality
data or HCHP cesarean rates to some intervention. I believe that regulatory
approaches are not very conducive to ongoing, creative, process improvement,
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
although regulation or accreditation may play an important role in getting
the process going. In general, process improvements require skilled assessment
and skilled management. Until and unless the efforts I have just mentioned
occur, "outcomes" is just a buzzword. It will wear thin and disappear from
our vocabulary. That would be very unfortunate, for we will have lost a
major opportunity to examine, evaluate, and improve the way we give medical
care.
ACKNOWLEDGMENTS
I wish to thank the following persons on the HCHP obstetrical data base
staff who developed and maintained this data base and who kindly made
available the data in this chapter: Kay Larholtz, statistical specialist; Debra
Cookson, project coordinator; Diana Parks Forbes, obstetrical database consultant;
and Donald M. Berwick, Vice-President for Quality of Care Measurement.
Representative terms from entire chapter:
hchp obstetricians
