Ch. 11 - Reasoning About the Design and Execution of Research

What are the eight steps of the scientific method?

1. Generate a testable question

2. Gather data and resources

3. Form a hypothesis

4. Collect new data

5. Analyze the data

6. Interpret the data and hypothesis

7. Publish results

8. Verify results.

What does the FINER method evaluate?

The value of a research question based on feasibility, interest, novelty, ethics, and relevance.

What is basic science research?

Research using chemicals, cell cultures, or animals to manipulate independent variables and observe dependent variable changes.

What are controls in experiments?

Controls correct for influences outside the model and can be:

• Positive controls: Ensure expected changes occur.

• Negative controls: Ensure no changes occur when none are expected.

What is the difference between accuracy and precision?

• Accuracy (validity): How close measurements are to the true value.

• Precision (reliability): How consistent the measurements are.

How is human subjects research different from basic science research?

It is subject to ethical constraints, often observational, and harder to control, making causal conclusions more difficult.

What are the three types of observational studies in human research?

• Cohort studies: Record exposures over time and assess outcomes.

• Cross-sectional studies: Assess exposure and outcome at the same time.

• Case-control studies: Assess outcome status and examine exposure history.

What are Hill’s criteria for causality in observational studies?

Temporality, strength, dose-response relationships, consistency, plausibility, alternative explanations, experiments, specificity, and coherence.

What are common forms of error in human subjects research?

• Bias: Systematic errors during data collection (e.g., selection bias, detection bias, Hawthorne effect).

• Confounding: A third variable affects both independent and dependent variables.

• Random error: Unpredictable variability in data.

What are the four principles of medical ethics?

• Beneficence: Do the most good with the least harm.

• Nonmaleficence: Do no harm.

• Respect for patient autonomy: Honor patient decisions.

• Justice: Distribute resources and treatments fairly.

What ethical principles were established by the Belmont Report?

• Respect for persons (autonomy, informed consent, confidentiality).

• Justice (fair study questions and subject selection).

• Beneficence (maximizing good and minimizing harm).

What is equipoise in research ethics?

The lack of knowledge about which treatment arm of a study is better for participants.

What is the difference between population data and sample data?

• Population data: Parameters from all individuals sharing a characteristic.

• Sample data: Statistics from a subset of the population

What is the difference between internal and external validity?

• Internal validity: Identifies causality between independent and dependent variables.

• External validity: Ability to generalize findings to the population described.

What is the difference between statistical and clinical significance?

• Statistical significance: Low likelihood that findings are due to chance.

• Clinical significance: Importance and usefulness of findings in patient care or outcomes.