Norgard 2013.
Study characteristics | ||
Methods | Retrospective cohort. Study period: 2003 to 2010 | |
Participants | Country: Denmark. CD patients who underwent abdominal surgery in the Danish National Patient Registry | |
Interventions | 1. Preoperative anti‐TNF therapy (n= 214) within 12 weeks 2. No preoperative anti‐TNF therapy (n= 2079) |
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Outcomes | Anastomotic leak, intraabdominal abscess, bacteremia within 30 days of surgery | |
Notes | NOS very high risk of bias overall | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Representativeness of the exposed cohort | Low risk | CD patients who underwent abdominal surgery from 2003 to 2010 |
Selection of the non exposed cohort | Low risk | Both groups obtained from the same database and time period |
Ascertainment of exposure | Low risk | Exposure identified by codes from the National Patient Registry and prescription database |
Demonstration that outcome of interest was not present at start of study | Unclear risk | Information not provided |
Comparability of cohorts (Controlled for critical factor/other medications) | High risk | OR adjusted for age, gender, comorbidity, steroids, duration of CD, year and length of inpatient stay was available for anastomotic leak and intraabodminal abscess outcomes separately. Combined event rate of anastomotic leak and intraabdominal abscess was used for our analysis. |
Comparability of cohorts (Controlled for additional factor) | High risk | See above |
Assessment of outcome | Low risk | Outcome identified by codes from the National Patient Registry |
Was follow‐up long enough for outcomes to occur | Low risk | 30 days |
Adequacy of follow up of cohorts | Low risk | All patients had 30 and 60 day follow up data after surgery |