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ASA NEWSLETTER
 
 
April 2005
Volume 69
Number 4

SOAP ‘SCOREs’ Big With New Adverse Complication Tracking Project

Robert D’ Angelo, M.D., Chair
SOAP Research Committee



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.

 


    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.
Robert D’ Angelo, M.D.


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