Phenobarbital (All indications)

Child/Infant death (> 28 days of life)

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.
S9160
R31496
Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020 Death (Mean follow up 3-4 years) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 1.77 [0.10;30.62] C
excluded (control group)
0/84   9/2,813 9 84
ref
S9161
R31514
Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Death (Mean follow up 3-4 years) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 2.18 [0.13;35.07] C 0/84   4,695/1,710,441 4,695 84
ref
S9179
R31638
Shankaran (Phenobarbital) (Other indications), 2002 Post-discharge deaths (NOS) days before delivery randomized controlled trial unexposed, sick Adjustment: Randomisation 2.37 [0.46;12.33] C 5/298   2/280 7 298
ref
S9172
R31556
Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 Death (from 6 to 13 years) throughout pregnancy prospective cohort unexposed, disease free excluded Adjustment: No Matched 4.84 [0.09;255.68] C
excluded (control group)
0/13   0/61 0 13
ref
S9173
R31581
Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Death (from 6 to 13 years) throughout pregnancy prospective cohort unexposed, sick Adjustment: No 0.60 [0.02;15.86] C 0/13   1/24 1 13
ref
Total 3 studies 1.87 [0.51;6.88] 4,703 395
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 Coste (Phenobarbital) (Controls unexposed, NOS), 2020Coste, 2020 1 2.18[0.13; 35.07]4,6958422%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Shankaran (Phenobarbital) (Other indications), 2002Shankaran, 2002 2 2.37[0.46; 12.33]729862%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991Van der Pol, 1991 3 0.60[0.02; 15.86]11316%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 1.87[0.51; 6.88]4,7033950.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.27[0.15; 10.56]4,696970%NACoste (Phenobarbital) (Controls unexposed, NOS), 2020 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2 case control studiescase control studies 0 RCTRCT 2.37[0.46; 12.33]7298 -NAShankaran (Phenobarbital) (Other indications), 2002 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.18[0.13; 35.07]4,69584 -NACoste (Phenobarbital) (Controls unexposed, NOS), 2020 1 unexposed, sickunexposed, sick 1.80[0.41; 7.83]83110%NAShankaran (Phenobarbital) (Other indications), 2002 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2 Tags Adjustment   - No  - No 1.27[0.15; 10.56]4,696970%NACoste (Phenobarbital) (Controls unexposed, NOS), 2020 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2   - Randomisation  - Randomisation 2.37[0.46; 12.33]7298 -NAShankaran (Phenobarbital) (Other indications), 2002 1 All studiesAll studies 1.87[0.51; 6.88]4,7033950%NACoste (Phenobarbital) (Controls unexposed, NOS), 2020 Shankaran (Phenobarbital) (Other indications), 2002 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 30.25.01.0

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, 9160

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.83[0.29; 27.59]4,695970%NACoste (Phenobarbital) (Controls unexposed, NOS), 2020 Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991 2 unexposed, sick controlsunexposed, sick controls 1.80[0.41; 7.83]83110%NAShankaran (Phenobarbital) (Other indications), 2002 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.77[0.10; 30.62]984 -NACoste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020 10.510.01.0