Focus Group Methodology

Miriam Bar-Din Kimel PhD

Senior Project Manager
MEDTAP International, Inc.
Presentation prepared for
The FDA Drug Safety & Risk Management Advisory Committee Meeting
Gaithersburg, Maryland
December 4, 2003
Overview of Presentation
 Overview of study method
 Methodology
 Strengths & limitations
 Application to the drug naming process
 Conclusions
Overview of Study Method
 Qualitative research method
 Address research questions that require
depth of understanding that cannot be
achieved through quantitative methods.
 Purpose: exploratory, pretesting,
triangulation, phenomenology
Purpose
 Gather background information
 Diagnose problems
 Stimulate new ideas or identify new
relationships
 Generate hypotheses
 Evaluate programs
 Interpret quantitative results
Focus Group Methodology
 Independent investigation
 Principal data source
 Multi-method study or program
 Qualitative & quantitative methods
 Triangulation
 Supplement
 Interpretation of quantitative data
Types of Focus Groups
 Traditional
 In-person, directive, structured
 Internet alternative
 Brainstorming
 In-person, nondirective, unstructured
 Nominal/Delphi technique
 Mail, directive, structured
 Internet alternative
 Field, natural
 In-person, spontaneous, unstructured
 Field, formal
 In-person, directive, semi-structured
Traditional Focus Groups
 8-12 participants
 Under direction of trained moderator
 Formal, directive, structured
 60-150 minutes
 Recorded, supplemented by field notes
 Observed by scientific team
Traditional Focus Groups
 Participants
 Break characteristics – populations
 Control characteristics
 # & nature of groups & sessions
 Purpose
 Design complexity
 Break characteristics
 Resources
Data – Qualitative/Textual
 Tape recordings
 Transcriptions
 2 hour session: 40 to 50 pages
 Field notes
Data Analysis
 Driven by underlying research question
 Qualitative
 Interpretive, constrained by context
 Topics – linked to group guidelines
 Steps
 Mechanical – organizing, subdividing
 Interpretive – developing subdivisions (code mapping),
search for patterns within subdivisions, drawing meaningful
conclusions
 Software: e.g.,The Ethnograph; Atlas.ti; QSR N6
 Reliability
 Repeated review of data
 Independent analysis by > two experienced analysts
Results
 Qualitative:
 Themes, Issues, Concerns
 Substantiating Quotes
 Quantitative:
 No. of participants who agreed or disagreed
 Frequency of themes within the group discussion
 Sample characteristics
Strengths & Limitations

Focus group methodology is only as

useful and as strong as its link to the
underlying research question and the
rigor with which it is applied.
Strengths
 Provides concentrated amounts of rich data,
in participants’ own words, on precisely the
topic of interest
 Interaction of participants adds richness to
the data that may be missed in individual
interviews
 Provides critical information in development
of hypotheses or interpretation of quantitative
data
Limitations
 Small number of participants
 Limited generalizability
 Group dynamics can be a challenge
 Particularly if moderator is inexperienced
 Interpretation
 Time-consuming
 Requires experienced analysts
Application to Drug Naming (1:2)

 Focus groups can:

 Elicit potential sources of confusion from the user’s
perspective
 Physicians, pharmacists, nurses, patients, caregivers
 Practice and ‘real world’ factors
 Identify situations in which confusion is most likely to occur
 Situations, conditions, patient populations
 User x situation interactions
 Prioritize empirical study
 Inform expert panels
 Participants, conditions, names
 Test conclusions of expert panels
 Alternative users – patients, caregivers
Application to Drug Naming (2:2)

 Focus groups can:

 Inform quantitative research design
 Laboratory or simulations
 Provide qualitative data to aid in the interpretation
of quantitative results
 Unexpected areas of confusion or lack of confusion
 Serve as an integral part of a multi-method
evaluation program
 Triangulation
 Provide qualitative foundation for designing risk
assessment and management studies
 Professional practice and home-use patterns
Conclusions
 Focus group methodology
 provides rich depth of understanding of the
phenomenon of interest
 can be used in isolation, or to complement
or supplement quantitative methods
 is as useful and as strong as its link to the
underlying research question and the rigor
with which it is applied.
Author Contact Information
Miriam Bar-Din Kimel PhD
Senior Project Manager
MEDTAP International, Inc
7101 Wisconsin Avenue, Suite 600
Bethesda, MD 20814
(301) 654-9729
kimel@medtap.com