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The Core of Clinical Research Design in 3 Moves: Object, Method, Analysis

1️⃣ Object Design: What’s the Clinical Problem?

Use the DEPTh Model to define your study’s core question:

DEPTh Type

Clinical Aim

Example Question

Diagnosis

Identify disease

“Can symptoms predict TB?”

Etiognosis

Find a cause

“Does drug X cause liver injury?”

Prognosis

Predict future outcomes

“What predicts ICU stay after surgery?”

Therapeutic

Assess treatment effect

“Does intervention A reduce readmission?”

Methodologic

Improve measurement tools

“Is test B reproducible in clinical use?”


2️⃣ Method Design: How Will You Study It?

Break the object into method components:

Element

What It Does

Study Domain

Clinical population & setting

Study Base (3x3x3)

Who, where, and when the sample is drawn

Determinants (X)

Risk factors, exposures, or treatments

Endpoints (Y)

What happens (outcome, diagnosis, recovery, etc)

Clinical Parameters

Time, rates, odds, mean change

Occurrence Equation

Links everything in one analytic model

✳️ Occurrence Equation

Model your outcome as a function of causes or predictors:


Where:

  • Y = Outcome (event, diagnosis, measurement)

  • Xs = Main exposures, treatments, or predictors

  • Confounders = Other variables that distort true relationship

  • Bias = Selection, measurement, or analysis artifacts

  • Random error = Chance variation

3️⃣ Analysis Design: How Will You Analyze It?

Match the analytic method to the DEPTh type:

Logic Type

Used For

Goal

Describe

All studies

Summarize population/data

Explain

Etiognostic, Therapeutic

Identify causal effects

Explore

Early phase, hypothesis-gen

Discover new relationships

Predict

Diagnostic, Prognostic

Forecast who gets what/when

🛠 Common tools:

  • Describe: Means, medians, proportions

  • Explain: Logistic/Cox/Linear regression

  • Predict: Risk scores, ML models, ROC/AUC

✅ Quick Recap

  • DEPTh = Your research compass 🧭

  • Occurrence Equation = Your modeling skeleton 💀

  • Design Triad:

    • Object = What are you solving?

    • Method = How will you study it?

    • Analysis = How will you prove or predict?


🧪 Practice Prompt

Try filling in this template for your next idea:

  • DEPTh Type:

  • Clinical Question:

  • Y =

  • f(Xs | Confounders)

  • Analysis Goal: Describe / Explain / Explore / Predict

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