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Clinical Research Variables and the Occurrence Equation

🔍 Why Start with Variables?

Every clinical research question—whether it’s about diagnosis, treatment, or prognosis—can be boiled down to a relationship between variables. Your job as a clinical investigator is to define those variables clearly and to make sure your study design respects the logic behind how one (or more) exposures (Xs) affect a specific outcome (Y).

The simplest way to conceptualize this? Think like a statistician with a stethoscope.


🧱 Meet Your Variable Trio

1. Study Determinants (X) = ตัวแปรต้น

  • These are your independent variables.

  • Can be an exposure (smoking), a treatment (drug), a biological factor (CRP level), or even a behavior.

  • Must be chosen based on your object design (e.g., Are you trying to diagnose, explain, predict, or treat?)

2. Study Outcomes (Y) = ตัวแปรตาม, ตัวแปรผลลัพธ์

  • These are dependent variables—what you’re trying to influence, predict, or explain.

  • Can be binary (dead/alive), ordinal (severity scale), or continuous (blood pressure, length of stay).

3. Other Variables

  • Covariates = variables related to Y that you adjust for.

  • Confounders = variables related to both X and Y that can bias the X→Y relationship.

  • Effect Modifiers = variables that alter the strength/direction of the X→Y effect (e.g., sex may change how a drug works).


🧪 Clinical Endpoint Parameters: The Numbers that Matter

After defining X and Y, you need a statistical effect measure:

  • Odds Ratio (OR) for case-control and logistic regression.

  • Risk Ratio (RR) for cohort studies.

  • Hazard Ratio (HR) for time-to-event/survival analysis.

  • Mean Difference for continuous outcomes.

These parameters directly link your hypothesis to interpretable clinical outcomes.

🔄 Enter the Occurrence Equation

🛠️ From Theory to Method: Design Flow Recap

Step

Description

Identify Clinical Challenge

Use DEPTh: diagnosis, etiognosis, prognosis, therapy, method

Translate into Question

e.g., “Does X cause Y?”

Define Study Domain & Variables

Who, what, and how are measured?

Select Endpoint Parameter

OR, RR, HR, Mean Difference

Build Occurrence Equation

Model X→Y with confounders in mind

🧩 Example: Etiognostic Study Using the Occurrence Equation

Let’s apply this to a concrete case.

🎯 Clinical Challenge (Etiognostic)

  • Event: Postoperative delirium

  • Suspected Cause: Benzodiazepine use

  • Setting: Elderly surgical inpatients


🧱 Object Design

Element

Value

DEPTh Type

Etiognostic

Clinical Question

Does preoperative benzodiazepine use cause increased risk of delirium after surgery?

Y (Outcome)

Post-op delirium (yes/no)

X (Determinant)

Benzodiazepine use within 48 hours pre-op

🧪 Method Design

Element

Value

Study Domain

Patients aged ≥65 undergoing major surgery

Study Base

Retrospective cohort (from EMR)

Calendar Time

Retrospective (past 3 years)

Covariates

Age, sex, cognitive status, ICU stay, surgery type

🔬 Occurrence Equation

✅ Summary Table

Step

Design Choice

DEPTh

Etiognostic

Study Design

Retrospective Cohort

Analysis

Logistic Regression

X (Determinant)

Benzodiazepine use

Y (Outcome)

Delirium

Occurrence Eq

Y = f(X | Confounders)


📌 Key Takeaways

  • The occurrence equation is the universal structure behind all clinical research designs.

  • DEPTh typing defines the function logic as causal vs predictive.

  • Distinguish X and Y early and precisely.

  • Match your analysis model to Y’s nature (binary, continuous, time-to-event).

  • Bake in your confounding control from the start.

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