2020 · Paediatric and Perinatal Epidemiology
Prenatal paracetamol exposure and neurodevelopmental outcomes in preschool‐aged children
Verdict
UNSCIENTIFIC
Neither the paradigm nor the study inside it passes. The verdict is unscientific.
1·Study methodology · inside the paradigm
UNSCIENTIFIC
Does not follow the scientific method within Psychiatric Model.
2·Paradigm · Psychiatric Model
UNSCIENTIFIC
Fails the tests. The worse layer decides.
How the verdict is decided
The verdict grades both layers: the paradigm this study assumes, and how the study was carried out inside it. Both must be scientific for the whole thing to be scientific. A clean method inside an unscientific paradigm is unscientific. An unscientific method inside a better paradigm is unscientific. A split on either layer is mixed. The worse layer decides.
1·Study methodology
Did this study test its claim with methods that are independent, falsifiable, and non-circular?
UNSCIENTIFIC
This study claims that using paracetamol in all three trimesters of pregnancy is linked to more emotional problems and less shyness in five-year-olds, and that short-term use poses no substantial risk. All three tests fail.
Independently Verifiable
Fail
Mothers ticked boxes on a form, and a scoring sheet turned the ticks into T scores and a cutoff of 63 turned a score into an internalising problem.
Falsifiable
Fail
Raw differences shrank after weighting, the pre-pregnancy group showed effects too, and the authors read any effect as confounding and any null as misclassification.
Non-Circular
Fail
The authors vouch for the behavior scales because they predict later child diagnoses, and those diagnoses are made with the same criteria the cutoffs came from.
Why
Mothers of about 33,000 children filled out forms in pregnancy listing the pills they took and for how many days. Five years later the same mothers ticked boxes about their child: does he use sentences, does she hit, is he shy. Scoring sheets turned the ticks into T scores, and psychiatric cutoffs of 63 and 65 sorted children into having communication, internalising or externalising problems. The authors weighted groups with statistics built from the mothers' own reports, then used pre-pregnancy pill use as a check. When that group showed effects too, they called it confounding. A child's behavior is visible. The problem label comes from the cutoffs, and no outside check on the label exists.
2·Paradigm · Psychiatric Model
Does the framework this study assumes pass the three tests?
UNSCIENTIFIC
Independently Verifiable
Fail
The shy or hitting child is visible, but the line where that becomes a clinical problem exists only in the cutoff table.
Falsifiable
Fail
When the findings seen at age three vanished by age five, the explanation was that problems evolve with age, so no result ends the framework.
Non-Circular
Fail
Each new scale is approved by agreeing with older diagnoses, and those diagnoses were set by the clinicians who wrote the criteria.
Why
Children who hit, cling or stay quiet are things any parent sees. The psychiatric model adds the rest: which behaviors go on which subscale, that a T score of 63 marks a clinical problem, and that the label points to something real inside the child. Nothing outside the questionnaires checks that, because the scales were written by clinicians and are judged good by matching later diagnoses made with the same criteria. When a finding fades, the field says symptoms change with age, problems are noticed more easily in older children, or the trait has many causes. That is what happened here when three-year findings disappeared at five. No result has to end the framework.
From the study
Communication problems were defined as children with T scores ≥65.
Children with T scores ≥63 were classified as having clinically significant externalising or internalising behaviour problems.
These tools show high internal consistency and are strongly predictive of later child diagnosis.
This indicates that there is unmeasured confounding and our observed associations may be confounded to some extent by unobserved maternal factors, such as personality traits or genetics.