TNF-alpha inhibitors

Congenital heart defects

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S4098
R8747		 Carman - Etanercept (Controls unexposed, disease free), 2017 Cardiovascular and circulatory malformations during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed, disease free excluded Adjustment: No 0.77 [0.23;2.60] C
excluded (control group) 		3/210   20/1,078 23 210
ref
S4099
R8762		 Carman - Etanercept (Controls unexposed, sick), 2017 Cardiovascular and circulatory malformations during pregnancy (anytime or not specified) excluded retrospective cohort (claims database) unexposed, sick Adjustment: No 1.32 [0.39;4.46] C
excluded (exposition period) 		3/210   21/1,932 24 210
ref
S3194
R5159		 Bröms a (Controls unexposed, disease free), 2016 Cardiovascular system 3 months or more before pregnancy or1st trimester population based cohort retrospective unexposed, disease free excluded Adjustment: No 1.89 [1.18;3.02] C
excluded (control group) 		18/683   17,656/1,250,192 17,674 683
ref
S3193
R5137		 Bröms a (Controls unexposed, sick), 2016 Cardiovascular system 3 months or more before pregnancy or1st trimester excluded population based cohort retrospective unexposed, sick Adjustment: Yes 1.60 [0.93;2.58]
excluded (exposition period) 		18/683   355/21,549 373 683
ref
S4074
R8630		 Cooper, 2014 Cardiac defects 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: No 9.39 [0.38;233.76] C 1/56   0/171 1 56
ref
Total 1 studies 9.39 [0.38;233.76] 1 56
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Cooper, 2014Cooper, 2014 9.39[0.38; 233.76]1560%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA0.920.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 9.39[0.38; 233.76]156 -NACooper, 2014 1 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 9.39[0.38; 233.76]156 -NACooper, 2014 1 Tags Adjustment   - No  - No 9.39[0.38; 233.76]156 -NACooper, 2014 1 All studiesAll studies 9.39[0.38; 233.76]156 -NACooper, 2014 10.520.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 3194, 4098

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 9.39[0.38; 233.76]156 -NACooper, 2014 10.510.01.0