Master’s Essay in Epidemiology I
P9419
Methods
Luisa N. Borrell, DDS, PhD
October 25, 2004

Slide 2

Methods
  The Methods section of a proposal will provide readers with an overview of whom you are studying and the statistical methods you will use to answer the question or test the hypothesis posed in the problem to be addressed

Proposal Abstract Methods Section
  In one paragraph, present the information that best describes your study in terms of:
Study design
Population
Variables to be examined
Outcome (s)
Exposures (or Interventions)
Covariates
Statistical analysis

Study designs and reasons for choosing a particular design
 Observational
 Cross-sectional
 Case-control
 Cohort (retrospective or prospective)

Study Designs and Choices
 Cont…
 Experimental
 Clinical trial
 Community intervention trial

Whom do you plan to study?
 Population
  From what population were subjects recruited or selected—target (AKA source or reference) or accessible population?
  Were the subjects obtained consecutively, by random sampling, or as volunteers?
  When were the participants enrolled in the study?

Whom do you plan to study? Cont…
 Population
 What were the characteristics in terms of age, gender, ethnicity, health status, socioeconomic status?
 What inclusion/exclusion criteria were used?
 Were issues of external/internal validity considered?

What are you measuring?
 Outcomes
 Exposure
 Covariates (Confounders, effect modifiers, or mediator variables)

As a review…
Measurement can be:
 Continuous
 Discrete
 Categorical
Two values-dichotomous
More than two values
 Nominal-Unordered
 Ordinal-Ordered

Outcome
How was the information to define the outcome collected?
How was the outcome measured?
How will you define the outcome?
Will you have to do any recoding?
If defined as categorical,  how many levels does the outcome variable have?

Exposure(s)
How was the information to define the exposure(s) collected?
How were the exposure(s) measured?
How will you define the exposure(s)?
How many levels do your categorical exposure variables have?
Will you recode?
Collapse categories
Set cutpoints for continuous variables
Develop an index or scoring system for combined exposures

Covariates
Why might the covariate be a
Confounder?
Effect modifier?
Mediator?
How is the covariate defined?
Is the covariate associated with the exposure?
Can the covariate cause the outcome?
Does the exposure/outcome relationship vary with levels of the covariate?
Can the exposure cause the covariate?

Statistical Analysis

Slide 15

Statistical Analysis
 Descriptive
 Continuous
 Categorical
 Bivariate analyses
 Multivariable approaches
 Any additional information

Statistical Analysis
 Descriptive
 Continuous
 Bivariate analyses

Nature of your Outcome:
Continuous

Statistical Analysis
 Descriptive
 Categorical
 Bivariate analysis

Nature of your Outcome:
Categorical

Statistical Analysis
 Descriptive
 Continuous
 Categorical
 Bivariate analysis
 Multivariable approaches

Bringing it all together: Outcome and Exposure

Statistical Analysis
 Descriptive
 Continuous
 Categorical
 Bivariate analysis
 Multivariable approaches
 Any additional information

Any additional information
Test for interaction
Test for trend

Example
 To examine the association between head trauma and seizures and epilepsy before and after controlling for age, gender, family history, physical and mental health, alcohol, drug
 Hypothesis:
  Head trauma increase the probability of head trauma and seizures and epilepsy after controlling for all covariates
  This association will depend on age, with younger people having a stronger association

Example…
 Individuals seeking medical care in Iceland over a 4 years period
 Cross-sectional
 Cohort
 Case-control
Matched
Unmatched

Back to our Example
 To examine the association between head trauma and seizures and epilepsy before and after controlling for age, gender, family history, physical and mental health, alcohol, drug
Hypothesis:
 Head trauma increase the probability of head trauma and seizures and epilepsy after controlling for all covariates
 This association will depend on age, with younger people having a stronger association

Example…
 Outcome: Febrile seizures, other provoked seizures and epilepsy
 Binary (yes/no)
 Exposure: Head trauma
 Binary
 Number of trauma

Example…
Covariates:
 Age-Continuous and categorical
 Gender-Categorical
 Family history-Categorical
 Physical and mental health-Summary score
 Alcohol-Categorical
 Drug-Categorical

Statistical Analysis
 Descriptive
 Continuous- t-tests, ANOVA
 Categorical- Chi-square tests
 Bivariate analysis
 Continuous-continuous/categorical- r
 Categorical-categorical-OR, RR

Statistical Analysis
 Multivariable approaches
 Continuous-continuous/categorical: Linear regression
 Categorical-categorical/continuous: Logistic regression/Cox Proportional Regression
 Any additional information

Statistical Analysis
 Any additional information
 Interaction

Then…
  The population for this study represents a random sample of individuals 16 to 28 years of age seeking medical care in 4 clinics during 1992 and 1996 in Iceland.  The outcome for this study will be defined as the first diagnosed seizure, febrile or due to other causes, after a head trauma.  Individuals seeking care for a head trauma will be considered as exposed and those seeking care for other traumas not involving the head as unexposed.  Age, gender, family history, self-rated physical and mental health, alcohol and drug consumption will be included as covariates.

Then…
   Descriptive statistics will be presented for all covariates by the outcome and the exposure status. t-, ANOVA  and chi-square tests will be used to assess significant differences between groups.  In addition, Pearson and Spearman correlation coefficients will be used to determine the association between the outcome and all other covariates included in the analyses.  Logistic regression will be used to assess the strength of the association between seizures and head trauma before and after controlling for all covariates in the analysis.  An interaction term between head trauma and age will be tested to determine whether the association between head trauma and seizures varies with age.