Ondansetron

Ventricular septal defect

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.
S4195
R9717		 Lemon, 2019 Neonatal ventricular septal defect 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 2.10 [1.10;4.00] 24/3,727   22/5,779 46 3,727
ref
S2757
R3944		 Zambelli-Weiner (Unexposed control, NOS), 2019 Ventricular septal defect 1st trimester nested case control unexposed (general population or NOS) Adjustment: Yes 1.29 [1.03;1.61] 81/959   9,058/122,164 9,139 959
ref
S2852
R3865		 Huybrechts (Control exposed to other treatment), 2018 Ventricular septal defect 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: Yes 1.07 [0.93;1.23]
excluded (control group) 		253/55,579   758/185,699 1,011 55,579
ref
S2844
R3835		 Huybrechts (Unexposed control), 2018 Ventricular septal defect 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.06 [0.96;1.17] 400/88,446   6,824/1,727,546 7,224 88,446
ref
S2853
R3966		 Parker, BDS study, 2018 Ventricular septal defect 1st trimester case control unexposed, sick Adjustment: Yes 1.10 [0.90;1.40] 114/489   1,213/6,711 1,327 489
ref
S2756
R3682		 Parker, NBDPS study, 2018 Ventricular septal defect 1st trimester case control unexposed, sick Adjustment: Yes 0.90 [0.60;1.30] 27/280   1,318/7,816 1,345 280
ref
S2778
R3784		 Fejzo (Mainly exposed to other treatements, sick), 2016 Ventricular septal defect 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No 2.32 [0.11;48.42] C
excluded (control group) 		2/952   0/441 2 952
ref
S2776
R3746		 Fejzo (Unexposed control, disease free), 2016 Ventricular septal defect 1st trimester retrospective cohort unexposed, disease free Adjustment: No 0.67 [0.12;3.69] C 2/952   4/1,286 6 952
ref
S2746
R3889		 Pasternak, 2013 Ventricular septal defect 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: No 1.41 [0.56;3.59] C 6/1,233   17/4,932 23 1,233
ref
Total 7 studies 1.13 [0.99;1.27] 19,110 96,086
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 Lemon, 2019Lemon, 2019 2.10[1.10; 4.00]463,7273%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Zambelli-Weiner (Unexposed control, NOS), 2019Zambelli-Weiner, 2019 1 1.29[1.03; 1.61]9,13995920%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Huybrechts (Unexposed control), 2018Huybrechts, 2018 2 1.06[0.96; 1.17]7,22488,44644%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Parker, BDS study, 2018Parker, BDS study, 2018 1.10[0.90; 1.40]1,32748921%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Parker, NBDPS study, 2018Parker, NBDPS study, 2018 0.90[0.60; 1.30]1,3452809%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Fejzo (Unexposed control, disease free), 2016Fejzo, 2016 3 0.67[0.12; 3.69]69521%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Pasternak, 2013Pasternak, 2013 1.41[0.56; 3.59]231,2332%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (7 studies) I2 = 25% 1.13[0.99; 1.27]19,11096,0860.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Unexposed control, NOS; 2: Unexposed control; 3: Unexposed control, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.26[0.86; 1.85]7,29994,35838%NALemon, 2019 Huybrechts (Unexposed control), 2018 Fejzo (Unexposed control, disease free), 2016 Pasternak, 2013 4 case control studiescase control studies 1.13[0.95; 1.35]11,8111,72826%NAZambelli-Weiner (Unexposed control, NOS), 2019 Parker, BDS study, 2018 Parker, NBDPS study, 2018 3 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.21[0.99; 1.49]16,43895,31742%NALemon, 2019 Zambelli-Weiner (Unexposed control, NOS), 2019 Huybrechts (Unexposed control), 2018 Fejzo (Unexposed control, disease free), 2016 Pasternak, 2013 5 unexposed, sickunexposed, sick 1.05[0.86; 1.27]2,6727690%NAParker, BDS study, 2018 Parker, NBDPS study, 2018 2 Tags Adjustment   - No  - No 1.19[0.53; 2.70]292,1850%NAFejzo (Unexposed control, disease free), 2016 Pasternak, 2013 2   - Yes  - Yes 1.13[0.98; 1.31]19,08193,90146%NALemon, 2019 Zambelli-Weiner (Unexposed control, NOS), 2019 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 5 All studiesAll studies 1.13[0.99; 1.27]19,11096,08625%NALemon, 2019 Zambelli-Weiner (Unexposed control, NOS), 2019 Huybrechts (Unexposed control), 2018 Parker, BDS study, 2018 Parker, NBDPS study, 2018 Fejzo (Unexposed control, disease free), 2016 Pasternak, 2013 70.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.02.21.0400.000Lemon, 2019Zambelli-Weiner (Unexposed control, NOS), 2019Huybrechts (Unexposed control), 2018Parker, BDS study, 2018Parker, NBDPS study, 2018Fejzo (Unexposed control, disease free), 2016Pasternak, 2013

Asymetry test p-value = 0.4534 (by Egger's regression)

slope=0.0471 (0.0753); intercept=0.5614 (0.6909); t=0.8126; p=0.4534

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 2778, 2852

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.21[0.99; 1.49]16,43895,31742%NALemon, 2019 Zambelli-Weiner (Unexposed control, NOS), 2019 Huybrechts (Unexposed control), 2018 Fejzo (Unexposed control, disease free), 2016 Pasternak, 2013 5 unexposed, sick controlsunexposed, sick controls 1.05[0.86; 1.27]2,6727690%NAParker, BDS study, 2018 Parker, NBDPS study, 2018 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.07[0.93; 1.23]1,01356,5310%NAHuybrechts (Control exposed to other treatment), 2018 Fejzo (Mainly exposed to other treatements, sick), 2016 20.510.01.0