TY - JOUR

T1 - Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial

AU - Antonsen, Sofie L

AU - Meyhoff, Christian Sylvest

AU - Lundvall, Lene

AU - Høgdall, Claus Kim

N1 - © 2010 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2010 Nordic Federation of Societies of Obstetrics and Gynecology.

PY - 2011/1/1

Y1 - 2011/1/1

N2 - OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits.DESIGN: Evaluation study.SETTING: Danish Gynecological Cancer Database (DGCD) and the Danish multicenter trial on perioperative oxygen and surgical-site infections (PROXI).SAMPLE: Paired data from 222 patients who participated in the PROXI trial taking place at Copenhagen University Hospital, Rigshospitalet between November 2006 and October 2008 and data from the DGCD.METHODS: Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics.MAIN OUTCOME MEASURES: Primary outcome was surgical-site infection. Other outcomes included re-operation, urinary tract infection, pneumonia and sepsis.RESULTS: Surgical-site infection was found in 21 of 222 patients (9.5%) in the PROXI trial versus 6 of 222 patients (2.7%) in the DGCD (p < 0.01, kappa 0.42). Twelve of 15 superficial and three of six deep or organ-space surgical-site infections were registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia).CONCLUSIONS: The randomized trial reported significantly more surgical-site infections than the clinical database. The DGCD reported only 50% of the deep and organ-space infections, and hence, the low-overall agreement indicates a need for more careful database registration.

AB - OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits.DESIGN: Evaluation study.SETTING: Danish Gynecological Cancer Database (DGCD) and the Danish multicenter trial on perioperative oxygen and surgical-site infections (PROXI).SAMPLE: Paired data from 222 patients who participated in the PROXI trial taking place at Copenhagen University Hospital, Rigshospitalet between November 2006 and October 2008 and data from the DGCD.METHODS: Outcomes within 30 days from the trial and the database were compared and levels of agreements were calculated with kappa-statistics.MAIN OUTCOME MEASURES: Primary outcome was surgical-site infection. Other outcomes included re-operation, urinary tract infection, pneumonia and sepsis.RESULTS: Surgical-site infection was found in 21 of 222 patients (9.5%) in the PROXI trial versus 6 of 222 patients (2.7%) in the DGCD (p < 0.01, kappa 0.42). Twelve of 15 superficial and three of six deep or organ-space surgical-site infections were registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia).CONCLUSIONS: The randomized trial reported significantly more surgical-site infections than the clinical database. The DGCD reported only 50% of the deep and organ-space infections, and hence, the low-overall agreement indicates a need for more careful database registration.

U2 - 10.1111/j.1600-0412.2010.01007.x

DO - 10.1111/j.1600-0412.2010.01007.x

M3 - Journal article

C2 - 21275918

VL - 90

SP - 72

EP - 76

JO - Acta Obstetricia et Gynecologica Scandinavica

JF - Acta Obstetricia et Gynecologica Scandinavica

SN - 0001-6349

IS - 1

ER -