Phenobarbital (All indications)

Spina bifida

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.
S10172
R37156		 Blotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 12.56 [0.51;310.72] C
excluded (control group) 		0/80   1/2,997 1 80
ref
S10042
R36292		 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Spina bifida 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 19.13 [1.18;308.86] C 0/80   616/1,875,733 616 80
ref
S9118
R31328		 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 31.42 [0.61;1613.76] C
excluded (control group) 		0/27   0/833 0 27
ref
S9120
R31335		 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Spina bifida throughout pregnancy population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 20.32 [1.02;403.19] C 0/27   3/3,773 3 27
ref
S9172
R31569		 Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 Spina bifida occulta throughout pregnancy prospective cohort unexposed, disease free excluded Adjustment: No Matched 4.74 [0.09;251.42] C
excluded (control group) 		0/12   0/55 0 12
ref
S9173
R31594		 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Spina bifida occulta throughout pregnancy prospective cohort unexposed, sick Adjustment: No 0.59 [0.02;15.81] C 0/12   1/22 1 12
ref
Total 3 studies 6.95 [0.78;61.60] 620 119
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 Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019Blotière, 2019 1 19.13[1.18; 308.86]6168037%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014Veiby, 2014 2 20.32[1.02; 403.19]32734%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991Van der Pol, 1991 3 0.59[0.02; 15.81]11230%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 37% 6.95[0.78; 61.60]6201190.250.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Phenobarbital) (Controls unexposed NOS) (Mixed indications; 2: Phenobarbital) (Controls unexposed, sick) (Mixed indications; 3: Phenobarbital) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 6.95[0.78; 61.60]62011937%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 19.13[1.18; 308.86]61680 -NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 1 unexposed, sickunexposed, sick 3.72[0.12; 118.19]43959%NAVeiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2 Tags Adjustment   - No  - No 6.95[0.78; 61.60]62011937%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 3 Controls   - epilepsy indication  - epilepsy indication 20.32[1.02; 403.19]327 -NAVeiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 6.95[0.78; 61.60]62011937%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 30.250.01.0

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 9172, 9118, 10172

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale12.08[1.24; 117.95]616920%NABlotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019 Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 2 unexposed, sick controlsunexposed, sick controls 3.72[0.12; 118.19]43959%NAVeiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls Out of scale18.10[1.50; 217.84]11070%NABlotière (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.510.01.0