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lthough advances in the subspecialty of obstetric
anesthesiology have made caring for pregnant women
safer than ever,1
peripartum complications related to anesthesia can
and do occur. The true incidence of serious complications
related to obstetric anesthesia remains unknown
since no large databases exist that specifically
capture this type of information.
Characteristics associated with rare complications
can best be identified using a large population
base rather than from prospective clinical studies
that typically enroll few patients. Furthermore
the incidence of complications at any individual
institution may be more indicative of practice patterns
unique to that institution and may occur more or
less frequently than in the general population.
In response to this problem, the Society for Obstetric
Anesthesia and Perinatology (SOAP), through its
Research Committee, has established a Serious
Complication Repository
(SCORE) Project to track adverse complications in
obstetric anesthesiology. Although a national database
would be a worthwhile goal, the repository will
initially attempt to capture reliable data from
150,000-200,000 deliveries per year from centers
across the United States and Canada.
Criteria for institutional participation in the
repository are a willingness to participate and
an established quality assurance (QA) program that
reliably captures serious obstetric anesthesia complications
at that institution. The Section on Obstetric Anesthesia
of the Department of Anesthesiology at Wake Forest
University School of Medicine in Winston-Salem,
North Carolina has been selected as the central
site for the repository.
Participating sites will complete simple, single-page
data collection forms quarterly and fax them to
the central site. Information on the mode of delivery,
type of anesthesia and postdural puncture headaches
will be reported on the data collection forms. In
addition, if a serious complication occurs during
that quarter, a brief synopsis detailing contributing
factors will be reported on a separate single complication
description form specific to each complication.
The complication description forms were designed
with the intent of gathering as much useful information
as possible while maintaining patient confidentiality
and minimizing the efforts required by the QA coordinators
to complete the forms.
Complications targeted by the repository will include
maternal death (whether or not due to anesthesia
care), cardiac arrest (whether or not due to anesthesia
care), epidural abscess/meningitis (central nervous
system [CNS] infection), epidural hematoma, serious
neurologic injury (any CNS or peripheral injury
requiring neuroimaging or a consultation), aspiration
(documented radiologic findings consistent with
the clinical setting), failed intubation, high spinal
(necessitating intubation or conversion to general
anesthesia), anaphylaxis and respiratory arrest
in labor and delivery.
The ultimate goals of the repository are to reliably
estimate the incidences of serious complications
and to improve patient safety by identifying factors
associated with each complication. If these factors
can be identified, recommendations could potentially
be made that either reduce the likelihood of the
complication or allow for faster or more appropriate
treatment.
Confidentiality will be maintained by de-identifying
all patient information on both the data collection
forms and in the repository database. Likewise institutional
confidentiality will be maintained by pooling all
data in the database.
The project was approved by the Wake Forest University
Institutional Review Board and its legal department
and was officially launched on October 1, 2004.
To date, 45 sites, including both large and small
private and academic practices, are participating
in the project. It is anticipated that data will
be captured from approximately 160,000 deliveries
during the first year.
The repository is an ongoing project, and any institution
willing to participate that can meet the QA requirements
can do so at any time. By including additional sites,
we hope to capture data on more than 1 million deliveries
within five years. Please contact Robert D’Angelo,
M.D., by telephone at (336) 718-8278 or e-mail at
<rdangelo@wfubmc.edu>
for additional information or if you wish to participate
in the repository.
Reference:
1. Hawkins JL. Anesthesia-related maternal mortality.
Clin Obstet Gynecol. 2003; 46:679-687.
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Robert D’ Angelo, M.D., is Section Head
and Vice-Chair of Obstetric Anesthesia, Department
of Anesthesiology, Wake Forest University School
of Medicine, Winston-Salem, North Carolina. |
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