Clinical Survey Design

 

 

For clinical survey design and IRB submission, we have to go through the following steps:

  1. Find topic and search literature (see attached)
  2. Get idea for hypothesis and write the outline for Background and Objectives
  3. Design clinical survey
  4. Generate survey questionnaire 
  5. Process IRB submission

 

General Information for Clinical Survey Design

Title

 

 

Bibliographic references

 

 

Background and

Purpose or hypothesis

 

 

Methodology

 

Study design and subject selection

Style: Cross sectional population based on multiple choice question-surveys

Study setting:

Study period:

Subjects/Participants:

Sample size based on

95% Confidence Intervals

Population

Probability of an α (type 0.05) error (false positive results)

Probability of a β (type II 0.2) error (false negative results)

Websites for sample calculation

http://www.raosoft.com/samplesize.html

http://www.custominsight.com/articles/random-sample-calculator.asp

http://www.surveysystem.com/sscalc.htm  

 

Variables and Questionnaire

Dependent (primary, outcome, reference category, index character)

Independent (Covariate or predictors)

Questionnaire design

 

Statistic Analysis

Frequency distributions - Chi-square (x2) tests.

Logistic regression models - unadjusted or adjusted odds ratios (aOR)

95% confidence intervals

Statistical significant are 2 sided with an α of .05 and P-values <0.05 were considered to be statistically significant.

 

Statistical Software

SAS (SAS Institute, Cary, NC)

SPSS (SPSS Inc. Chicago, IL)

Stata  (Stata Corp, College Station, TX)

 

Conduct Survey

 

Participating

 

Data Analysis