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Focus Group Methodology

Miriam Bar-Din Kimel PhD

Senior Project Manager

MEDTAP International, Inc.

Presentation prepared forThe FDA Drug Safety & Risk Management Advisory Committee Meeting

Gaithersburg, Maryland

December 4, 2003

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Overview of Presentation Overview of study method

Methodology

Strengths & limitations

Application to the drug naming process

Conclusions

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Overview of Study Method Qualitative research method

Address research questions that requiredepth of understanding that cannot beachieved through quantitative methods.

Purpose: exploratory, pretesting,triangulation, phenomenology

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Purpose Gather background information

Diagnose problems Stimulate new ideas or identify new

relationships

Generate hypotheses Evaluate programs

Interpret quantitative results

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Focus Group Methodology Independent investigation

Principal data source

Multi-method study or program

Qualitative & quantitative methods

Triangulation

Supplement

Interpretation of quantitative data

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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

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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

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Traditional Focus Groups Participants

Break characteristics populations

Control characteristics

# & nature of groups & sessions Purpose

Design complexity Break characteristics

Resources

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Data Qualitative/Textual Tape recordings

Transcriptions 2 hour session: 40 to 50 pages

Field notes

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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 meaningfulconclusions

Software: e.g.,The Ethnograph; Atlas.ti; QSR N6 Reliability

Repeated review of data Independent analysis by > two experienced analysts

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Results Qualitative:

Themes, Issues, Concerns

Substantiating Quotes

Quantitative:

No. of participants who agreed or disagreed

Frequency of themes within the group discussion

Sample characteristics

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Strengths & Limitations

Focus group methodology is only asuseful and as strong as its link to theunderlying research question and the

rigor with which it is applied.

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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 individualinterviews

Provides critical information in developmentof hypotheses or interpretation of quantitativedata

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Limitations Small number of participants

Limited generalizability Group dynamics can be a challenge

Particularly if moderator is inexperienced

Interpretation Time-consuming

Requires experienced analysts

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Application to Drug Naming (1:2)

Focus groups can: Elicit potential sources of confusion from the users

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

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Application to Drug Naming (2:2)

Focus groups can: Inform quantitative research design

Laboratory or simulations

Provide qualitative data to aid in the interpretationof quantitative results Unexpected areas of confusion or lack of confusion

Serve as an integral part of a multi-methodevaluation program Triangulation

Provide qualitative foundation for designing riskassessment and management studies Professional practice and home-use patterns

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Conclusions Focus group methodology

provides rich depth of understanding of thephenomenon of interest

can be used in isolation, or to complementor supplement quantitative methods

is as useful and as strong as its link to theunderlying research question and the rigorwith which it is applied.

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Author Contact InformationMiriam Bar-Din Kimel PhD

Senior Project ManagerMEDTAP International, Inc

7101 Wisconsin Avenue, Suite 600

Bethesda, MD 20814(301) 654-9729

kimel@medtap.com