PMID- 18554586
OWN - NLM
STAT- MEDLINE
DCOM- 20090708
LR  - 20090601
IS  - 1556-5653 (Electronic)
IS  - 0015-0282 (Linking)
VI  - 91
IP  - 6
DP  - 2009 Jun
TI  - Clinical outcome monitoring in a reproductive surgery unit: a prospective cohort 
      study in 796 patients.
PG  - 2638-42
LID - 10.1016/j.fertnstert.2008.03.048 [doi]
AB  - OBJECTIVE: To systematically monitor the frequency and risk factors of adverse 
      events (AEs) in a reproductive surgery endoscopy unit. DESIGN: Prospective cohort 
      study. SETTING: Academic research institution. PATIENT(S): All consecutive 
      surgical patients of a reproductive surgery unit from December 2005 to March 
      2007. INTERVENTION(S): Monitoring for predefined AEs by trained observers. MAIN 
      OUTCOME MEASURE(S): 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. RESULT(S): 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. CONCLUSION(S): Clinical outcome monitoring is a useful tool for assessing the 
      outcome quality of reproductive surgery by identifying potentially preventable 
      AEs and associated risk factors.
FAU - Bentz, Eva-Katrin
AU  - Bentz EK
AD  - Department of Gynecological Endocrinology and Reproductive Medicine, Medical 
      University of Vienna, Vienna, Austria.
FAU - Imhof, Martin
AU  - Imhof M
FAU - Pateisky, Norbert
AU  - Pateisky N
FAU - Ott, Johannes
AU  - Ott J
FAU - Huber, Johannes C
AU  - Huber JC
FAU - Hefler, Lukas A
AU  - Hefler LA
FAU - Tempfer, Clemens B
AU  - Tempfer CB
LA  - eng
PT  - Journal Article
DEP - 20080612
PL  - United States
TA  - Fertil Steril
JT  - Fertility and sterility
JID - 0372772
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Cohort Studies
MH  - Female
MH  - Gynecologic Surgical Procedures/adverse effects/*standards
MH  - Humans
MH  - Middle Aged
MH  - Monitoring, Physiologic/methods
MH  - Multivariate Analysis
MH  - Organization and Administration
MH  - Prospective Studies
MH  - Regression Analysis
MH  - Reoperation/statistics & numerical data
MH  - Surgical Procedures, Operative/adverse effects/*standards
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2008/06/17 09:00
MHDA- 2009/07/09 09:00
CRDT- 2008/06/17 09:00
PHST- 2008/02/14 00:00 [received]
PHST- 2008/03/14 00:00 [revised]
PHST- 2008/03/18 00:00 [accepted]
PHST- 2008/06/17 09:00 [pubmed]
PHST- 2009/07/09 09:00 [medline]
PHST- 2008/06/17 09:00 [entrez]
AID - S0015-0282(08)00717-6 [pii]
AID - 10.1016/j.fertnstert.2008.03.048 [doi]
PST - ppublish
SO  - Fertil Steril. 2009 Jun;91(6):2638-42. doi: 10.1016/j.fertnstert.2008.03.048. 
      Epub 2008 Jun 12.