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□ ChatGPT한테 물어 봤습니다.

- MCID를 임상 유의성 판단목적으로는 군간 비교에 사용하지 말라고 하더군요.

- 대답을 받는데 10초도 안걸렸습니다.

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질문: why the MCID should not be used in comparing the two groups? would you please take an example for my easier understanding?

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GPT답변 :

The MCID can be used to assess the clinical significance of treatment effects within a specific treatment group. It represents the smallest change that patients perceive as meaningful and can guide the interpretation of treatment outcomes.

However, when comparing two groups, such as an active treatment group and a placebo or control group, the use of MCID for direct comparison between the groups may not be appropriate. This is because the MCID is determined within specific patient populations and may not be universally applicable or directly transferable between different treatment groups.

Let's consider an example to illustrate this point. Suppose we have a clinical trial evaluating a new medication for chronic pain. The active treatment group receives the new medication, and the control group receives a placebo. In this case, the primary outcome measure is pain intensity, and the MCID for pain intensity has been determined within the active treatment group.

Now, if we were to compare the change in pain intensity between the active treatment group and the control group using the MCID, it might lead to erroneous conclusions. The MCID determined within the active treatment group may not be directly applicable to the control group, as the control group is not receiving the active treatment. The magnitude of improvement in pain intensity may differ between the two groups due to various factors, including the placebo effect.

Therefore, when comparing treatment and control groups, other statistical and clinical significance measures, such as effect sizes, confidence intervals, or pre-specified endpoints, are typically used to evaluate the differences between the groups.

It's important to consult the specific guidance document or consult with regulatory authorities for detailed recommendations and considerations on appropriate measures for comparing treatment and control groups in clinical trials.