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Why the Four Components are Key
(An Example)

Imagine you’ve just been told you have high cholesterol and have just seen an advertisement on TV claiming a brand new type of medication (we’ll call it “New Agent”) dramatically lowers cholesterol. You search the internet and find that the study was based on a very large double-blind randomized controlled trial, which you’ve learned is the most rigorous type of study to evaluate the benefit of therapy. For the sake of this example let’s also imagine this study is flawless. You’re considering asking your physician to prescribe this medication for you. But how do you know if this medication is really the best option for you?

While the television ad and supporting study seems to provide the right answer, you may discover it was not the right question to begin with.

If you use the Four Components of a Well-Framed Question, you would reflect on the
1. Patient Population; 2. Intervention; 3. Comparison Intervention; and 4. Outcomes represented in (and omitted from) the advertisement.

In the scenario above, the question implied by the television ad is:

“In patients with high cholesterol,
is the ‘New Agent’ effective
in reducing cholesterol levels?”

In other words, in patients with high cholesterol, is the ‘New Agent’ effective (when compared to placebo, or doing nothing) in reducing cholesterol levels? While the answer to the question in this ad may be a definitive “yes,” what is clearly missing is the third component of the question, an appropriate Comparison Intervention. A better question here is not whether the new agent works, but rather whether it works better than the current standard treatment for this condition.

(If you are interested why there are so many studies in the medical literature that compare new agents versus placebo read more here.)

In addition, there are three other issues you need to consider:

Are the patients involved in the study similar to you;
Can you get the new agent to begin with;
And finally, do the outcomes in the study directly matter to you? For example, outcomes reflecting quality and/or length of life would matter more than a change in lab tests alone.

Resolving the Example

With knowledge of the four key parts of the clinical question, reflect back on the TV advertisement:

Patient Population: There is no indication in the advertisement that this patient is similar to you, but when you read the study you note that all patients were older than 45 years and all had been diagnosed with coronary heart disease and many had experienced heart attacks. If you were only 35 years old and otherwise healthy, this study would not be as relevant to you.
Intervention: You check with your plan and discover this new medication is not covered and you would have to pay a lot out of pocket to get it.
Comparison Intervention: Most doctors would acknowledge that any one of the statin class of drugs would be an appropriate standard of care for treatment in this situation. The study would have been far more informative had it been compared against this standard therapy.
Outcomes: The study primarily reflected changes in cholesterol. It would have been far more informative had it shown how the new agent reduced heart attacks, stroke and death.

Based on the television advertisement for the new agent and the study it represents, the question was not the right question, and you and your doctor do not have the information needed to choose the new agent.

The Well-Framed Question of Efficacy

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Empowering Health and Wellbeing

Why the Four Components are Key
(An Example)

Resolving the Example