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Focus Group Methodology

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

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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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