DATA INTERPRETATION AND CONFOUNDING EXERCISE

JOSH MATTHEWS
MPH 604

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 (1) The Epidoria Birth Weight Study

Background In the small island nation of Epidoria, a team of reproductive

epidemiologists has been studying the relationship between very low birth
weight and risk of cognitive, motor, and behavioral problems. Five years ago
these investigators initiated a study. Using birth certificate files and delivery
room entry logs, these investigators attempted to identify all full-term births in
Epidoria over a 6-month period. The investigators enrolled all low birth weight
babies and a representative sample of normal birth weight babies into their
study. The investigators then examined the children every year until age 3
years. During the last examination, the investigators administered a
standardized developmental screening test to assess personal-social, language,
and motor-adaptive skills. Based on this test, the investigators classified the
children into two groups: normal development and delayed development.

The results from the study were:

Development
Delayed Normal Total
Low 140 220 360
Birth Weight
Normal 77 283 360
Total 217 503 720

a) What kind of a study is this (1 point)? What is the exposure under study?
What is the outcome under study ?
This would be a cohort study that does not have control or experimental
groups. From the data samples two groups have been created and the study is
attempting to understand an association of personal-social, language, and
motor-adaptive skills and if low weight are at risk of personal-social, language,
and motor-adaptive skills. Exposure being birth weight, low vs normal and the
outcome being development.

b) Calculate the crude cumulative incidence ratio (relative risk).

Low= 140/360 = 0.389

Normal = 77/360 = 0.214
Relative risk = 0.389/0.214 = 1.82

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Background (cont.) To account for the possibility that environmental lead
exposure might confound the relationship between birth weight and
developmental status, blood lead levels were determined from blood samples
collected at the age 3-year visit. Elevated lead levels (> 10 micrograms/ dL)
were found in 173 of the low birth weight children (88 of whom had delayed
development according to their screening test). Elevated lead levels were also
found in 72 of the normal birth weight children (24 of whom had delayed
development).

c) Carry out a stratified analysis of birth weight and developmental delay,

controlling for blood lead level. Create 2x2 tables for each stratum of lead
level and estimate the relative risk for each stratum.

Development/Lead levels (less than 10 micro grams/dl)

Delayed Normal Total
Birth Low 88 85 173
Weight Normal 24 48 72
Total 112 133 245

Development/Lead levels (more than 10 micro grams/dl)

Delayed Normal Total
Birth Low 52 135 187
Weight Normal 53 235 288
Total 105 370 475

Less than 10 micro grams/dl

Delayed low birth/ blood level above 10 mg rate ratio= 88/173 = 0.509
Normal birth weight rate ratio = 24/72 = 0.333

Relative risk ratio = 0.509/0.333 = 1.53

More than 10 micro grams/dl

Delayed low birth/ blood level below 10 mg rate ratio = 52/187 = 0.278
Normal birth weight rate ratio = 53/288 = 0.184

Relative risk ratio = 0.278/0.184 = 1.51

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d) Comparing the findings from the crude and stratified analysis, is there a
suggestion of confounding by lead exposure in this example?

Using this data, you can see that risk in low birth is 1.82 greater than in
normal weight kids. In a stratified analysis is it approximately 1.5, less than 10
micro grams 1.53, and more than 10 micro grams 1.51. As a result, the rick is
higher for lead exposure greater than 10 micro grams, and less for less than 10
micro grams.

e) Is there evidence of an association between blood lead level and the primary
exposure variable in this study (hint create a 2x2 table for blood lead level
and exposure)?

Development
lead level less than lead level more than Total
10 10
Birth Low 173 187 360
Weight Normal 72 288 360
Total 245 475 720

Low /blood level above 10 mg = 173/245 = 0.7

Rate ratio/ normal= 187/475 = 0.4
Relative risk ratio=0.4/0.7 = 1.79

Yes, the risk ration of more than 10 micro grams of lead in lower weight kids is
much greater than in normal children.

f) Is there evidence of an association between blood lead level and the outcome
in this study?

Yes, based on the above calculations lead levels and risk of personal-social,
language, and motor-adaptive skills show evidence of correlation. This is based
on risk ratio of greater than/ less than lead levels, as well as low/ normal
weight kids where in there is a 1.82 risk (from D).

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g) Based on all of this information would you judge blood lead level to be a
confounder of the association between birth weight and delayed
development? Explain your answer.
I would expect yes, that from the greater risk though this appears less related
to blood levels of lead. When blood levels of lead are used it seems less relevant
and more of a confounder.

h) What are two changes in the study design would have avoided the potential
confounding effects of blood lead level? What are the advantages and
disadvantages of these alternatives?

Adding another study, or potentially doing this very study with the
expectation of blood lead levels could be helpful. It seems that this was
added much later? Perhaps using lead levels from the beginning would have
been more helpful and less confounding?