Clinical outcome monitoring in a reproductive surgery unit: a prospective cohort study in 796 patients.
OBJECTIVE
To systematically monitor the frequency and risk factors of adverse events (AEs) in a reproductive surgery endoscopy unit.


METHODS
Prospective cohort study.


METHODS
Academic research institution.


METHODS
All consecutive surgical patients of a reproductive surgery unit from December 2005 to March 2007.


METHODS
Monitoring for predefined AEs by trained observers.


METHODS
Number of preventable and not preventable AEs, medical errors, and system problems. Univariate analysis and multivariate logistic regression were used to identify risk factors of AEs.


RESULTS
Seven hundred ninety-six women were included. We identified 60 AEs in 45 patients (risk 6%; 95% confidence interval [CI] 1%-11%). Adverse events were postoperative fever (n = 1), wound breakdown (n = 1), intraoperative or postoperative administration of packed erythrocytes (n = 6), surgical revision (n = 7), unplanned readmission (n = 5), transfer to intensive care unit (n = 1), conversion (n = 8), intraoperative organ injury (n = 9), blood loss >500 mL (n = 3), surgery canceled (n = 15), and other AEs (n = 4). Six patients (risk 0.8%; 95% CI 0-2%) had multiple AEs. One (0.01%) and 11 (1.4%) AEs were deemed due to medical errors and system problems, respectively. Twelve and 48 AEs were deemed preventable and not preventable, respectively. In a univariate and multivariate analysis, only duration of surgery (odds ratio 3.78; 95% CI 1.95-7.33) was significantly associated with having an AE.


CONCLUSIONS
Clinical outcome monitoring is a useful tool for assessing the outcome quality of reproductive surgery by identifying potentially preventable AEs and associated risk factors.
Department of Gynecological Endocrinology and Reproductive Medicine, Medical University of Vienna, Vienna, Austria.
Eva-Katrin
EK
Bentz
Martin
M
Imhof
Norbert
N
Pateisky
Johannes
J
Ott
Johannes C
JC
Huber
Lukas A
LA
Hefler
Clemens B
CB
Tempfer
D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000592:standards*; D006801:Humans; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D015999:Multivariate Analysis; D009934:Organization and Administration; D011446:Prospective Studies; D012044:Regression Analysis; D012086:Reoperation / Q000706:statistics & numerical data; D013514:Surgical Procedures, Operative / Q000009:adverse effects / Q000592:standards*; D016896:Treatment Outcome; D055815:Young Adult