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BACKGROUND/RATIONALE:
Hypothesis: Intra-operative variables amenable to intervention by the anesthesiologist/anesthetist, such as heart rate, blood pressure, temperature, and arterial oxygen saturation are important determinants of both short- and long-term outcomes from surgery after adjusting for important patient and procedural characteristics.
OBJECTIVE(S):
The research objectives of this retrospective cohort study are to:
· Analyze data from disparate anesthesia information management systems (AIMS) to understand the variability in data recording;
· Develop and apply preliminary data standards that will allow the merging of data from disparate AIMS;
· Merge archived AIMS data on intra-operative physiology from approximately 19,000 patients from seven Veterans Health Administration (VA) medical centers with the VA National Surgical Quality Improvement Program (NSQIP) data on patient-related risks, operative procedures, and outcomes; and
· Perform multivariable analyses to assess the associations between altered intra-operative physiology and adverse perioperative outcomes.
METHODS:
Research Design: Retrospective cohort study.
This study will merge intra-operative anesthesia management data from approximately 19,000 patients from sever VA medical centers with data from the National Surgery Quality Improvement Program (NSQIP). The NSQIP database has data on patient-related risks as well as operative procedures and outcomes. We will perform multivariable analyses to assess the associations between altered intra-operative physiology and adverse perioperative outcomes.
FINDINGS/RESULTS:
1. Because of the increased security in the VA system since January 2007, we have developed a secure data transfer plan that has been approved by Andrew Rikarts, CISSP, ISSEP, NSA IAM/IEM, GSEC, CSO/CSP VA Enterprise Technical Security Officer. The VA’s Enterprise Technical Security Officer recently approved our plan for enhanced data security for the transfer of personal health information for this study (e-mail to Network 19 ISO June 6, 2007). The major components of this plan are:
• The use VA-approved encryption software that meets the NIST (National Institute of Standards) FIPS 140-2 requirements (see http://csrc.nist.gov/cryptval/140-2.htm). The Denver VA Information Resources Management Service (IRMS) has provided Encryption Plus Secure Export by GuardianEdge that meets this requirement.
• Each site will create an encrypted file of their AIMS (Anesthesia Information Monitoring System) data using the above software that will be provided to them on a CD. A document providing detailed directions for the software set-up and encryption steps will be provided to each site (attached).
• The encrypted file will be placed on an external hard drive provided by study personnel from the Denver VA (other storage media do not have sufficient space for the very large files of AIMS data).
• The external hard drive will be sent by Federal Express to Sung-joon Min, PhD at his office at the Denver VA with a receipt signature required.
• The key used to encrypt (and to be used to unencrypt) the data will be sent to Dr. Min via VA Outlook with PKI encryption.
• The data will be unencrypted by Dr. Min at the Denver VA and downloaded to a server that has been set up for this study within the Denver VA IRMS.
2. AIMS data has been successessfully transferred from 2 sites in the study:
Seattle VAMC - 15,491 unique patients; 16,741 unique cases
Dallas VAMC - 17,607 unique patients; 15,145 unique cases
3. IRB approval has been obtained at the Washington DC and Pittsburg VAMCs. Data transfer using the secure data transfer plan described in 1. is in progress.
4. IRB approval is pending at the Houston, Cleveland and Spokane VAMCs.
IMPACT:
The results of this study will determine if the maintenance of normal intra-operative physiology improves postoperative outcomes. At the completion of this study, the results will be distributed to anesthesia care providers within the VA system so that they can utilize this information in their day-to-day management of veterans undergoing surgical procedures.
PUBLICATIONS:
None at this time.
DRA:
Health Services and Systems
DRE:
Technology Development and Assessment, Communication and Decision Making
Keywords:
Adverse events, Surgery, Informatics
MeSH Terms:
none
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