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