Sample Size

Sample Size

Purpose and Rationale

Why Sample Size Matters

Sample size is crucial because:

  1. Statistical Power

    • Affects ability to detect effects
    • Influences confidence in results
    • Determines study reliability
  2. Resource Management

    • Impacts study costs
    • Affects time requirements
    • Influences feasibility
  3. Research Quality

    • Affects precision of estimates
    • Influences generalizability
    • Impacts study validity

The Rationale Behind Sample Size

  1. Why We Need It

    • Too small: Miss important effects
    • Too large: Waste resources
    • Just right: Optimal balance
  2. How It Works

    • Balances statistical needs
    • Considers practical constraints
    • Ensures adequate power

Factors Affecting Sample Size

Statistical Considerations

Factor Effect How to Address
Effect size Smaller effect = larger n Use realistic estimates
Power Higher power = larger n Choose appropriate level
Significance Lower α = larger n Set appropriate α
Variability More variation = larger n Improve measurement

Practical Considerations

Factor Impact Solution
Resources Limited budget Optimize design
Time Limited time Plan efficiently
Population Limited access Consider alternatives
Ethics Participant burden Minimize n when possible

Calculation Methods

For Different Study Designs

Design Formula Considerations
One sample n=(Zα/2+Zβ)2σ2δ2 Single group
Two samples n=2(Zα/2+Zβ)2σ2δ2 Two groups
Paired samples n=(Zα/2+Zβ)2σd2δ2 Before-after
Proportions n=(Zα/2+Zβ)2p(1p)δ2 Binary outcomes

Software Tools

Tool Features Best For
G*Power Comprehensive Most analyses
R packages Flexible Custom needs
Online calculators Quick Simple cases

Planning Process

Step-by-Step Approach

  1. Define Parameters

    • Expected effect size
    • Desired power
    • Significance level
    • Expected variability
  2. Consider Constraints

    • Available resources
    • Time limitations
    • Population access
    • Ethical considerations
  3. Calculate Initial Size

    • Use appropriate formula
    • Apply correction factors
    • Consider design effects
  4. Adjust as Needed

    • Account for attrition
    • Consider clustering
    • Adjust for multiple tests
    • Round to practical number

Common Scenarios

Clinical Trials

Phase Considerations Typical Size
I Safety Small (20-80)
II Efficacy Medium (100-300)
III Effectiveness Large (300-3000)
IV Post-marketing Very large

Survey Research

Type Considerations Typical Size
National Representativeness 1000+
Regional Local focus 300-1000
Specialized Specific population 100-500

Best Practices

Planning Guidelines

  1. Before Calculation

    • Review literature
    • Consult experts
    • Consider alternatives
    • Document assumptions
  2. During Calculation

    • Use conservative estimates
    • Consider multiple scenarios
    • Account for practicalities
    • Document process
  3. After Calculation

    • Justify final size
    • Consider alternatives
    • Plan for contingencies
    • Document rationale

Common Mistakes

Mistake Problem Solution
Too small Low power Use power analysis
Too large Waste resources Consider costs
No justification Poor planning Document rationale
Ignoring constraints Unrealistic Consider limitations

Reporting Guidelines

Essential Elements

  1. What to Report

    • Calculation method
    • Assumptions made
    • Parameters used
    • Justification
  2. How to Present

    • Clear explanation
    • Supporting rationale
    • Alternative considerations
    • Limitations