Natalizumab

Preterm (< 37 weeks)

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.
S3656
R7595
Nguyen (control exposed to IFN), 2019 Pre-term (<37 weeks) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 1.44 [0.76;2.76] C
excluded (control group)
16/57   57/268 73 57
ref
S3657
R7598
Nguyen (control unexposed, sick), 2019 Pre-term (<37 weeks) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 1.08 [0.59;1.97] C 16/57   182/686 198 57
ref
S3778
R8083
Portaccio (control exposed to IFN), 2018 Preterm delivery (< 37 weeks) early pregnancy prospective cohort unexposed, sick Adjustment: No 0.58 [0.26;1.30] C 12/54   25/76 37 54
ref
S3777
R8071
Portaccio (control unexposed, sick), 2018 Preterm delivery (< 37 weeks) early pregnancy prospective cohort unexposed, sick excluded Adjustment: No 1.14 [0.57;2.30] C
excluded (control group)
12/54   63/315 75 54
ref
S3770
R8059
Ebrahimi (control unexposed, disease free), 2015 Premature (< 37 weeks) 3 months or more before pregnancy or1st trimester prospective cohort unexposed, disease free excluded Adjustment: No 0.79 [0.27;2.33] C
excluded (control group)
6/76   9/92 15 76
ref
S3769
R8052
Ebrahimi (control unexposed, sick), 2015 Premature (< 37 weeks) 3 months or more before pregnancy or1st trimester excluded prospective cohort unexposed, sick Adjustment: No 0.49 [0.17;1.43] C
excluded (exposition period)
6/76   10/67 16 76
ref
Total 2 studies 0.84 [0.46;1.52] 235 111
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 Nguyen (control unexposed, sick), 2019Nguyen, 2019 1 1.08[0.59; 1.97]1985759%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Portaccio (control exposed to IFN), 2018Portaccio, 2018 2 0.58[0.26; 1.30]375441%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 31% 0.84[0.46; 1.52]2351110.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: control unexposed, sick; 2: control exposed to IFN;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.84[0.46; 1.52]23511131%NANguyen (control unexposed, sick), 2019 Portaccio (control exposed to IFN), 2018 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 0.84[0.46; 1.52]23511131%NANguyen (control unexposed, sick), 2019 Portaccio (control exposed to IFN), 2018 2 Tags Adjustment   - No  - No 0.84[0.46; 1.52]23511131%NANguyen (control unexposed, sick), 2019 Portaccio (control exposed to IFN), 2018 2 All studiesAll studies 0.84[0.46; 1.52]23511131%NANguyen (control unexposed, sick), 2019 Portaccio (control exposed to IFN), 2018 20.25.01.0

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 3770, 3777, 3656

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 0.95[0.64; 1.41]3101650%NANguyen (control unexposed, sick), 2019 Portaccio (control exposed to IFN), 2018 Portaccio (control unexposed, sick), 2018 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.44[0.76; 2.76]7357 -NANguyen (control exposed to IFN), 2019 10.510.01.0