Why do a Feasibility Study?

 

You need to obtain information on a number of aspects crucial to the successful conduct of a clinical study before you conduct a large study. Examples of issues that can be addressed in a feasibility study include:

 

  1. Recruitment Strategy: assess recruitment capability at your site

·        Site demographics

·        Prevalence of the condition under study

·        Capability of the institution of attracting eligible patients

·        Could perform a single-group short-term feasibility study using the larger study’s eligibility criteria

 

  1. Rationale for choice of an intervention

·        Technique of choice is appropriate for the condition of interest

·        Comparison treatment is appropriate for the study parameters

·        Need to do thorough literature review; could conduct a case series or a pilot study including all treatment groups anticipated in larger study

 

  1. Eligibility Criteria: enough must be known about patient characteristics which may affect treatment response to identify the appropriate criteria for inclusion

·        Need to do thorough literature review; could conduct case series; could conduct a small single-group study with one intervention collecting extensive descriptive information on patients’ baseline characteristics

 

  1. Outcome Measures

·        Need to identify reliable, valid and clinically responsive measures

·        Measures need to be sensitive to treatment effects that are meaningful to patients

·        Need to determine the amount of change that is clinically meaningful

·        Need to do thorough literature review; could conduct a small intervention study using several outcome measures to compare

 

  1. Power Analysis: a sample size adequate for demonstrating clinically and statistically significant changes in the outcome measure must be calculated

·        Need to do thorough literature review; could conduct a small intervention study and assess effect size; should consult with a biostatistician in performing the power analysis for the large study

 

 

Adapted from “Exploratory Research: the What, Why and How of Starting Small”

Cheryl Hawk, DC, PhD and Cynthia R. Long, PhD

ACC-RAC 2002 Invited Concurrent Session