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Hormone therapy and heart disease Since 1976 the Nurses' Health Study has followed more than 100,000 nurses. Every two years, the nurses fill out a questionnaire about their habits and their health. Results from this study indicated that postmenopausal women have a reduced risk of heart disease if they take a hormone replacement drug. a. Suppose the hormone-replacement drug actually has no effect. Identify a potential lurking variable that could explain the results of the observational study. (Hint: Suppose that the women who took the drug tended to be more conscientious about their personal health than those who did not take it.) b. Recently a randomized experiment called the Women's Health Initiative was conducted by the National Institutes of Health to see if hormone therapy is truly helpful. The study, planned to last for eight years, was stopped after five years when analyses showed that women who took hormones had \(30 \%\) more heart attacks. This study suggested that rather than reducing the risk of heart attacks, hormone replacement drugs actually increase the risk. \({ }^{3}\) How is it that two studies could reach such different conclusions? (For attempts to reconcile the studies, see a story by Gina Kolata in The New York Times, April 21, 2003.) c. Explain why randomized experiments, when feasible, are preferable to observational studies.

Short Answer

Expert verified
Lurking variables like health-consciousness could explain differences. Randomized experiments control variables, showing causal relationships. They found hormone therapy increased heart attack risk.

Step by step solution

01

Identify a Potential Lurking Variable

In the context of the observational study, a potential lurking variable could be the conscientiousness of the women about their health. This means that women who are more health-conscious might be more likely to take hormone replacement therapy. This trait could lead them to engage in other health-promoting behaviors, such as regular exercise and a balanced diet, which could lower their risk of heart disease. Consequently, the apparent reduction in heart disease risk might not be directly due to the hormone therapy itself, but rather these healthier lifestyle choices.
02

Understanding Study Differences

The two studies reached different conclusions because they used different methodologies. The Nurses' Health Study was observational, meaning it only observed and reported correlations between hormone use and heart disease, potentially attributing effects to hormone therapy due to lurking variables like health-conscious behaviors. In contrast, the Women's Health Initiative was a randomized experiment, which allows for better control over variables. By randomly assigning participants to receive either hormone therapy or a placebo, this study could more reliably determine causal relationships by eliminating the influence of other variables, revealing that hormone therapy actually increased the risk of heart attacks by 30%.
03

Preferring Randomized Experiments

Randomized experiments are generally preferable to observational studies because they can establish a cause-and-effect relationship by controlling for confounding variables. In a randomized trial, participants are randomly assigned to treatment or control groups, ensuring that any differences in outcomes are likely due to the treatment itself rather than other factors. This method reduces the impact of lurking variables, allowing for more accurate conclusions about the effects of the treatment being studied.

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Key Concepts

These are the key concepts you need to understand to accurately answer the question.

Lurking Variables
When looking at observational studies like the Nurses' Health Study, it's important to identify potential lurking variables. These are hidden factors that can affect the outcome of a study without being accounted for explicitly. For example, in the context of this study, women who opted for hormone replacement therapy might have been more health-conscious overall. Being conscientious could mean they also maintained healthier lifestyles, with regular exercise and proper diets.

This means the perceived reduced risk of heart disease might be mistakenly attributed to the hormone replacement therapy itself, rather than these other healthier behaviors. Lurking variables can create misleading associations, making it seem as though one factor is directly causing another. However, it may just be that third-party variables are influencing the results. By acknowledging lurking variables, researchers and readers can understand why observational studies need careful interpretation.
Causal Relationships
One of the primary strengths of randomized experiments like the Women's Health Initiative is their ability to determine causal relationships. In simple terms, causal relationships indicate that one event (such as hormone replacement therapy) directly causes another event (like an increased risk of heart attacks).

Randomized experiments achieve this clarity by controlling for lurking and confounding variables. This is accomplished through the random assignment of participants to different groups, ensuring that each group is, theoretically, comparable on all other levels apart from the treatment under investigation. In this case, hormone therapy or a placebo.
  • This method helps isolate the effect of the treatment, making it easier to draw conclusions about its direct impact.
  • By eliminating the possibility of unintentional factors impacting results, we can trust that any difference found can be attributed to the treatment itself.


Understanding causal relationships in health studies is crucial for making informed medical decisions and creating public health guidelines.
Health Studies
Health studies are research efforts aimed at understanding important health-related questions, such as the impact of drugs or therapies. In comparing observational studies like the Nurses' Health Study and randomized experiments like the Women's Health Initiative, one can see the diverse methods and challenges involved in health research.

Observational studies track participants over time and report on trends or associations they find; however, they might not be suitable for drawing causal conclusions due to potentially unaccounted lurking variables. Conversely, randomized experiments are designed to explore cause and effect in health studies by using controlled setups that eliminate interference from external variables the best they can.
  • Both types of studies can provide valuable insights, but their findings must be interpreted within the context of their methodology.
  • Understanding the differences between these methods allows us to appreciate the nuance and complexity involved in health research.
  • Accurate health studies drive recommendations and guidelines that shape our health practices and policies.


Recognizing how these studies operate provides a foundation for evaluating medical research and its implications for real-world health decisions.

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