Vigabatrin (Epilepsy)

Major congenital malformations

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.
S7801
R23018		 Vajda (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2019 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 18.80 [0.36;971.86] C
excluded (control group) 		0/1   20/406 20 1
ref
S7802
R23019		 Vajda (Vigabatrin) (Controls unexposed, sick), 2019 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 31.00 [0.56;1711.11] C 0/1   5/176 5 1
ref
S7668
R22698		 Tomson (Vigabatrin), 2018 Malformed Offspring at least 1st trimester prospective cohort exposed to other treatment, sick Adjustment: No 4.68 [0.24;91.38] C 0/4   74/2,514 74 4
ref
S8282
R26224		 Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2010 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 13.80 [0.22;853.65] C
excluded (control group) 		0/1   2/37 2 1
ref
S8283
R26225		 Mawer (Vigabatrin) (Controls unexposed, disease free), 2010 Major malformations 1st trimester prospective cohort unexposed, disease free excluded Adjustment: No Matched 42.85 [0.79;2330.91] C
excluded (control group) 		0/1   6/285 6 1
ref
S8284
R26226		 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Major malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 26.33 [0.38;1837.92] C 0/1   1/41 1 1
ref
S6069
R15790		 Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006 Major congenital malformation 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 2.64 [0.14;49.38] C
excluded (control group) 		0/6   21/647 21 6
ref
S6070
R15797		 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 Major congenital malformation 1st trimester prospective cohort unexposed, sick Adjustment: No 2.34 [0.12;45.78] C 0/6   8/227 8 6
ref
Total 4 studies 6.93 [1.26;38.13] 88 12
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 Vajda (Vigabatrin) (Controls unexposed, sick), 2019Vajda, 2019 1 31.00[0.56; 1711.11]5118%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Tomson (Vigabatrin), 2018Tomson, 2018 2 4.68[0.24; 91.38]74433%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Mawer (Vigabatrin) (Controls unexposed, sick), 2010Mawer, 2010 3 26.33[0.38; 1837.92]1116%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Morrow (Vigabatrin) (Controls unexposed, sick), 2006Morrow, 2006 4 2.34[0.12; 45.78]8633%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 6.93[1.26; 38.13]88120.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Vigabatrin) (Controls unexposed, sick; 2: Vigabatrin; 3: Vigabatrin) (Controls unexposed, sick; 4: Vigabatrin) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 6.93[1.26; 38.13]88120%NAVajda (Vigabatrin) (Controls unexposed, sick), 2019 Tomson (Vigabatrin), 2018 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 4 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 8.40[1.05; 67.40]1480%NAVajda (Vigabatrin) (Controls unexposed, sick), 2019 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 3 exposed to other treatment, sickexposed to other treatment, sick 4.68[0.24; 91.38]744 -NATomson (Vigabatrin), 2018 1 Tags Adjustment   - No  - No 6.93[1.26; 38.13]88120%NAVajda (Vigabatrin) (Controls unexposed, sick), 2019 Tomson (Vigabatrin), 2018 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 4 All studiesAll studies 6.93[1.26; 38.13]88120%NAVajda (Vigabatrin) (Controls unexposed, sick), 2019 Tomson (Vigabatrin), 2018 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 40.5100.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-5.17.02.5990.000Vajda (Vigabatrin) (Controls unexposed, sick), 2019Tomson (Vigabatrin), 2018Mawer (Vigabatrin) (Controls unexposed, sick), 2010Morrow (Vigabatrin) (Controls unexposed, sick), 2006

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6069, 8282, 8283, 7801

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale42.85[0.79; 2330.91]61 -NAMawer (Vigabatrin) (Controls unexposed, disease free), 2010 1 unexposed, sick controlsunexposed, sick controls 8.40[1.05; 67.40]1480%NAVajda (Vigabatrin) (Controls unexposed, sick), 2019 Mawer (Vigabatrin) (Controls unexposed, sick), 2010 Morrow (Vigabatrin) (Controls unexposed, sick), 2006 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 5.98[1.11; 32.16]117120%NAVajda (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2019 Tomson (Vigabatrin), 2018 Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2010 Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006 40.510.01.0