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Health Risks of Ionizing Radiation: - Clark University

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8 Introduction<br />

In epidemiological studies researchers <strong>of</strong>ten look<br />

for and highlight “significant results”. This is<br />

confusing because the word ‘significant’ has a<br />

statistical meaning that is different from its everyday<br />

meaning. To a person concerned about health risks<br />

from an exposure, any disease, risk or exposure<br />

is significant. When epidemiologists speak <strong>of</strong><br />

significance, however, they are talking about a very<br />

specific definition. Statistical significance typically<br />

refers to the circumstance where the results <strong>of</strong> a<br />

study have less than a 5% likelihood <strong>of</strong> occurring by<br />

chance. The standard for calling a result significant<br />

can vary, but in any credible scientific report a study<br />

author will always provide the criteria that they use<br />

for significance. In this overview we will frequently<br />

refer to the significance <strong>of</strong> results; we will use the<br />

scientific definition <strong>of</strong> the word.<br />

Statistical power depends on large numbers.<br />

Imagine a very small community <strong>of</strong> two people.<br />

Each person has a small chance <strong>of</strong> getting cancer and<br />

when they are exposed to a carcinogen this chance<br />

increases. Imagine that these people are exposed to<br />

a small amount <strong>of</strong> a carcinogen and ten years later<br />

one <strong>of</strong> them develops cancer. You could fairly say<br />

that half <strong>of</strong> the community developed cancer. On the<br />

other hand it would be very difficult to show that it<br />

wasn’t just by chance. As a more realistic example<br />

consider a community <strong>of</strong> several thousand people. In<br />

this community, based on national rates, we expect<br />

that 80 people will get cancer during our study. This<br />

is an uncertain rate, however, varying from place to<br />

place, and so 75 or 85 cases <strong>of</strong> cancer might not be<br />

unusual. But what if this community is exposed to<br />

radiation from a small nuclear release and in our study<br />

period 87 people get cancer? These are 7 cases more<br />

than we expected, but there is still some possibility<br />

that this increase was just bad luck. Epidemiology<br />

is based on estimating the likelihood that the result<br />

occurred by chance and calculating the significance<br />

<strong>of</strong> the result. In our example an epidemiologist<br />

might say that there was a 12% chance <strong>of</strong> getting 87<br />

cancer cases without any exposure. In this case the<br />

result would not be significant. If the epidemiologist<br />

said that there was only a 2% chance <strong>of</strong> getting this<br />

result, however, it would be significant.<br />

The 5% level is a widely accepted convention<br />

for significance but it is <strong>of</strong> course an arbitrary cut<strong>of</strong>f.<br />

Statistical significance can introduce a bias when<br />

the scientific community is less enthusiastic about<br />

publishing statistically inconclusive findings. There<br />

is an even stronger potential bias when a statistically<br />

inconclusive result is held up as evidence that “there<br />

was no effect”. In cases where conditions prevent a<br />

robust epidemiological design, for example a small<br />

community exposed to a small amount <strong>of</strong> radiation, a<br />

real effect might not be detected and the community<br />

will be faced with a scientific publication implying<br />

that there was no risk from the exposure. In 1991<br />

the National Research Council’s Committee on<br />

Environmental Epidemiology went so far as to<br />

say that conventional approaches to environmental<br />

epidemiology may not only place an unfair burden<br />

on communities for proving causation but may<br />

actually be promoting bad science. The report stated<br />

that “under some circumstances this stipulation<br />

[the high threshold for statistical significance] can<br />

stifle innovation in research when studies that fail to<br />

meet the conventional criteria for a positive finding<br />

are prematurely dismissed”. There is a classic and<br />

important phrase relating to this issue: the absence <strong>of</strong><br />

evidence is not evidence <strong>of</strong> absence. In other words,<br />

it can never be proven that there was “no risk”, even<br />

when we can’t detect a significant increase. We<br />

discuss further the notation <strong>of</strong> significance in the<br />

‘risk terminology’ section below.<br />

Study designs. There are two categories <strong>of</strong><br />

epidemiological study design, descriptive and<br />

analytical. Descriptive studies explore associations<br />

between exposure and disease and sometimes precede<br />

more expensive and time-consuming analytical<br />

studies. Ecologic studies, for example, compare<br />

disease rates between populations based on public<br />

records and use data at the group level (county, town,<br />

etc.) and not the individual level. Descriptive studies<br />

are capable <strong>of</strong> generating suggestive evidence <strong>of</strong> a<br />

cause-and-effect relationship but are not very good<br />

at ruling out alternative explanations for an observed<br />

effect.<br />

Analytical studies are usually considered to be<br />

stronger and more reliable than descriptive studies<br />

because they can address confounding variables<br />

and help rule out alternative explanations. The two<br />

analytical study designs are known as case-control<br />

studies and cohort studies. In a case-control design<br />

people who have a particular disease (cases) are<br />

matched with people who do not (controls). The cases

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