1984 · The Lancet
RANDOMISED CONTROLLED TRIAL OF EFFECT OF RAW AND HOLDER PASTEURISED HUMAN MILK AND OF FORMULA SUPPLEMENTS ON INCIDENCE OF NEONATAL INFECTION
Verdict
SCIENTIFIC
The study follows the scientific method and does not operate inside a theoretical framework. The verdict is scientific.
1·Study methodology · no theoretical framework
SCIENTIFIC
Follows the scientific method. No theoretical framework attached.
2·Paradigm · Basic Epidemiological Comparison
NOT APPLICABLE
No theoretical framework. The study verdict decides.
How the verdict is decided
This study does not operate inside a theoretical framework. Using hospital records, billing codes, or diagnostic names as labels on visible events is not the same as depending on that framework. The verdict is the study methodology score alone.
1·Study methodology
Did this study test its claim with methods that are independent, falsifiable, and non-circular?
SCIENTIFIC
This paper claims supplementary formula feeds inhibit the protective effect of human milk against neonatal infection, and that pasteurisation reduces that protective effect. All three tests pass.
Independently Verifiable
Pass
A baby with neonatal infection is visibly sick, and anyone can count that.
Falsifiable
Pass
If the feeding groups had the same infection rates, the claim would have died.
Non-Circular
Pass
The groups were defined by what went into the feeding tube, not by a test that presupposes the conclusion.
Why
The study randomly assigned 226 high-risk neonates to four feeding groups: raw human milk, pasteurised human milk, and each combined with formula. It counted how many babies in each group developed infection. The group given pasteurised milk and formula had a 33% infection rate, compared to 10.5% for raw milk alone. A baby with neonatal infection is visibly sick. Anyone can count that without accepting any theory about why the baby is sick. The groups were defined by physical feeding regimens, not by tests that assume the conclusion. If infection rates had been the same across all groups, the claim would have been disproved. The comparison is arithmetic on visible events, and nothing in the design filters out a negative result.
2·Paradigm · Basic Epidemiological Comparison
The three tests do not apply. There is no theoretical framework.
NOT APPLICABLE
Why
The study counts visible events in defined groups. A baby getting sick is visible regardless of whether you accept germ theory, terrain theory, or any other model of disease. The feeding groups are physical interventions. The comparison is arithmetic on those visible events. There is no model-dependent instrument sorting the groups, no absorber ready to rescue a null result, and no loop between definition and detection. The three tests do not apply because there is no paradigm being assumed to produce the observation.
From the paper
The infection rate in the group given pasteurised human milk and formula (33%) was significantly higher than the rates in the groups given raw human milk (10.5%), pasteurised human milk (14.3%), and raw human milk and formula (16%).