In this analysis, the point estimate of malignancy risk was higher in etanercept-treated patients, although the results were not statistically significant. The approach of obtaining individual patient data of RCT in cooperation with trial sponsors allowed important insights into the methodological advantages and challenges of sparse adverse event data meta-analysis.

Objective The National Healthcare Safety Network classifies breast operations as clean procedures with an expected 1–2% surgical site infection (SSI) incidence. We assessed differences in SSI incidence following mastectomy with and without immediate reconstruction in a large, geographically diverse population. Design Retrospective cohort study. Patients Commercially-insured women aged 18–64 years with ICD-9-CM procedure or CPT-4 codes for mastectomy from 1/1/2004–12/31/2011. Methods Incident SSIs within 180 days after surgery were identified by ICD-9-CM diagnosis codes. The incidence of SSI after mastectomy +/− immediate reconstruction was compared by the chi-square test. Results From 2004–2011, 18,696 mastectomy procedures among 18,085 women were identified, with immediate reconstruction in 10,836 (58%) procedures. The 180-day incidence of SSI following mastectomy with or without reconstruction was 8.1% (1,520/18,696). Forty-nine percent of SSIs were identified within 30 days post-mastectomy, 24.5% between 31–60 days, 10.5% between 61–90 days, and 15.7% between 91–180 days. The incidence of SSI was 5.0% (395/7,860) after mastectomy-only, 10.3% (848/8,217) after mastectomy plus implant, 10.7% (207/1,942) after mastectomy plus flap, and 10.3% (70/677) after mastectomy plus flap and implant (p<0.001). The SSI risk was higher after bilateral compared with unilateral mastectomy with (11.4% vs. 9.4%, p=0.001) and without (6.1% vs. 4.7%, p=0.021) immediate reconstruction. Conclusions SSI incidence was two-fold higher after mastectomy with immediate reconstruction than after mastectomy alone. Only 49% of SSIs were coded within 30 days after operation. Our results suggest stratification by procedure type will facilitate comparison of SSI rates after breast operations between facilities.

Background.There are limited data on risk factors for surgical site infection (SSI) after open or laparoscopic cholecystectomy.Methods.A retrospective cohort of commercially insured persons aged 18–64 years was assembled using International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) procedure or Current Procedural Terminology, 4th edition codes for cholecystectomy from December 31, 2004 to December 31, 2010. Complex procedures and patients (eg, cancer, end-stage renal disease) and procedures with pre-existing infection were excluded. Surgical site infections within 90 days after cholecystectomy were identified by ICD-9-CM diagnosis codes. A Cox proportional hazards model was used to identify independent risk factors for SSI.Results.Surgical site infections were identified after 472 of 66566 (0.71%) cholecystectomies; incidence was higher after open (n = 51, 4.93%) versus laparoscopic procedures (n = 421, 0.64%; P < .001). Independent risk factors for SSI included male gender, preoperative chronic anemia, diabetes, drug abuse, malnutrition/weight loss, obesity, smoking-related diseases, previous Staphylococcus aureus infection, laparoscopic approach with acute cholecystitis/obstruction (hazards ratio [HR], 1.58; 95% confidence interval [CI], 1.27–1.96), open approach with (HR, 4.29; 95% CI, 2.45–7.52) or without acute cholecystitis/obstruction (HR, 4.04; 95% CI, 1.96–8.34), conversion to open approach with (HR, 4.71; 95% CI, 2.74–8.10) or without acute cholecystitis/obstruction (HR, 7.11; 95% CI, 3.87–13.08), bile duct exploration, postoperative chronic anemia, and postoperative pneumonia or urinary tract infection.Conclusions.Acute cholecystitis or obstruction was associated with significantly increased risk of SSI with laparoscopic but not open cholecystectomy. The risk of SSI was similar for planned open and converted procedures. These findings suggest that stratification by operative factors is important when comparing SSI rates between facilities.

Objective To compare the risk of suicide in adults using the antidepressant venlafaxine compared with citalopram, fluoxetine, and dothiepin. Results Venlafaxine users had a higher burden of risk factors for suicide, including previous suicide attempts and proxies for severe depression or depression that was difficult to treat. In the analysis for completed suicides, unadjusted and adjusted hazard ratios for venlafaxine compared with citalopram were 2.44 (95% confidence interval 1.12 to 5.31) and 1.70 (0.76 to 3.80), for venlafaxine compared with fluoxetine were 2.85 (1.37 to 5.94) and 1.63 (0.74 to 3.59), and for venlafaxine compared with dothiepin were 2.54 (1.07 to 6.02) and 1.31 (0.53 to 3.25). Compared with other study drugs, venlafaxine was also associated with an increased risk of attempted suicide, but adjustment for measured confounders substantially reduced the hazard ratios. Conclusions Venlafaxine use was consistently associated with higher risk of suicide compared with citalopram, fluoxetine, and dothiepin. Venlafaxine users had a higher burden of suicide risk factors, however, and adjustment for measured confounders substantially reduced the excess risks. Since the secondary data used in this analysis allowed only indirect and partial measurements of potential confounders, it is possible that residual confounding explains much, if not all, of the observed excess risk.

Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC.