# Presentation: 454421

## 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