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Focus Group Methodology

Explore the strengths, limitations, and applications of focus group methodology, particularly in drug naming processes. Learn about traditional and innovative focus group types, data analysis methods, and practical applications to improve drug naming.

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Focus Group Methodology

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  1. 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

  2. Overview of Presentation • Overview of study method • Methodology • Strengths & limitations • Application to the drug naming process • Conclusions

  3. 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

  4. Purpose • Gather background information • Diagnose problems • Stimulate new ideas or identify new relationships • Generate hypotheses • Evaluate programs • Interpret quantitative results

  5. Focus Group Methodology • Independent investigation • Principal data source • Multi-method study or program • Qualitative & quantitative methods • Triangulation • Supplement • Interpretation of quantitative data

  6. 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

  7. 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

  8. Traditional Focus Groups • Participants • Break characteristics – populations • Control characteristics • # & nature of groups & sessions • Purpose • Design complexity • Break characteristics • Resources

  9. Data – Qualitative/Textual • Tape recordings • Transcriptions • 2 hour session: 40 to 50 pages • Field notes

  10. 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

  11. Results • Qualitative: • Themes, Issues, Concerns • Substantiating Quotes • Quantitative: • No. of participants who agreed or disagreed • Frequency of themes within the group discussion • Sample characteristics

  12. 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.

  13. 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

  14. Limitations • Small number of participants • Limited generalizability • Group dynamics can be a challenge • Particularly if moderator is inexperienced • Interpretation • Time-consuming • Requires experienced analysts

  15. 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

  16. 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

  17. 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.

  18. 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

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