Qualitative research and content validity: developing best practices based on science and experience
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Establishing content validity for both new and existing patient-reported outcome (PRO) measures is central to a scientifically sound instrument development process. Methodological and logistical issues present a challenge in regard to determining the best practices for establishing content validity.
This paper provides an overview of the current state of knowledge regarding qualitative research to establish content validity based on the scientific methodological literature and authors’ experience.
Conceptual issues and frameworks for qualitative interview research, developing the interview discussion guide, reaching saturation, analysis of data, developing a theoretical model, item generation and cognitive debriefing are presented. Suggestions are offered for dealing with logistical issues regarding facilitator qualifications, ethics approval, sample recruitment, group logistics, taping and transcribing interviews, honoraria and documenting content validity.
It is hoped this paper will stimulate further discussion regarding best practices for establishing content validity so that, as the PRO field moves forward, qualitative research can be evaluated for quality and acceptability according to scientifically established principles.
KeywordsAssessing content validity Patient-reported outcomes (PRO) development Qualitative research
- 1.Nunally, J., & Bernstein, I. (1994). Psychometric theory (3rd ed., p. 104). McGraw-Hill: New York.Google Scholar
- 3.U.S. Department of Health and Human Services. (2008). Food and drug administration. Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. Rockville, MD. http://www.fda.gov/cder/guidance/index.htm.
- 4.Denzin, N., & Lincoln, Y. (Eds.). (2003). Collection and interpreting qualitative materials (2nd ed.). Thousand Oaks, CA: Sage.Google Scholar
- 5.Snape, D., & Spencer, L. (2004). The foundations of qualitative research. In J. Ritchie & J. Lewis (Eds.), Qualitative research practice: A guide for social science students and researchers (pp. 1–23). London: SAGE.Google Scholar
- 7.Friedland, G. H. (2006). HIV medication adherence: The intersection of biomedical, biobehavioral, and social science research and clinical practice. Journal of Acquired Immune Deficiency Syndromes, 43(Suppl 1), 53–59.Google Scholar
- 15.Paterniti, D. A., Chen, M. S., Chiechi, C., Beckett, L. A., Horan, N., Turrell, C., et al. (2005). Asian Americans and cancer clinical trials: A mixed-methods approach to understanding awareness and experience. Cancer Supplement, 104(12), 3015–3024.Google Scholar
- 19.Glaser, B., & Strauss, A. (1967). The discovery of grounded theory. Chicago: Aldine Press.Google Scholar
- 21.Charmaz, K. (2003). Qualitative interviewing and grounded theory analysis. In J. A. Holstein & J. F. Gubrium (Eds.), Inside interviewing: New lenses, new concerns (pp. 311–330). Thousand Oaks, CA: Sage.Google Scholar
- 22.Patton, M. (2002). Qualitative research and evaluation methods (3rd ed.). Thousand Oaks, CA: Sage.Google Scholar
- 24.Corbin, J., & Strauss, A. (2007). Basics of qualitative research (3rd ed.). Newbury Park, CA: Sage.Google Scholar
- 27.Stewart, D., Shamdasani, P. N., & Rook, D. W. (2006). Focus groups (2nd ed.). Thousand Oaks, CA: Sage.Google Scholar
- 31.Greenbaum, T. (2000). Moderating focus groups: A practical guide for group facilitation. Thousand Oaks, CA: Sage.Google Scholar
- 32.Morgan, D. (1997). Focus groups as qualitative research (2nd ed.). Thousand Oaks, CA: Sage.Google Scholar
- 35.Willis, G. B. (2004). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks: Sage.Google Scholar
- 40.Poland, B. (2003). Transcription quality. In J. A. Holstein & J. F. Gubrium (Eds.), Inside interviewing: New lenses, new concerns (pp. 267–288). Thousand Oaks, CA: Sage.Google Scholar
- 41.Bernard, H. R. (2005). Research methods in anthropology (4th ed.). Walnut Creek, CA: Rowman Altamira.Google Scholar
- 45.Ritchie, J., Spencer, L., & O’Connor, W. (2003). Carrying out qualitative analysis. In J. Ritchie & J. Lewis (Eds.), Qualitative research practice: A guide for social science students and researchers (pp. 219–262). London: Sage.Google Scholar
- 46.Hruschka, D., Schwartz, D., St John, D., Picone-Decaro, E., Jenkins, R., & Carey, J. (2004). Reliability in coding open-ended data: Lessons learned from HIV behavioral research. Field Methods 307–331.Google Scholar
- 48.Bradburn, N. M., Sudman, S., & Wansink, B. (2004). Asking questions. New York: John Wiley and Sons.Google Scholar
- 49.Acquadro, C., Conway, C., Wolf, B., Anfray, C., Hareendran, A., Mear, I., et al. (2008). Development of a standardized classification system for the translations of patient-reported outcome (PRO) measures. Quality of Life Newsletter, 39, 5.Google Scholar
- 51.Beatty, P. C., & Willis, G. B. (2007). Research synthesis: The practice of cognitive interviewing. Public Opinion Quarterly, 1–25.Google Scholar
- 52.Willis, G. B. (1999). Cognitive interviewing: A “how to” guide. Resource document. National Cancer Institute. http://appliedresearch.cancer.gov/areas/cognitive/interview.pdf. Accessed 2 May 2009.
- 54.U.S. Department of Health and Human Services. (2008). Food and drug administration. CFR—Code of Federal Regulations Title 21: Part 812—Investigational Device Exemptions. Resource Document. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=812.140.
- 55.U.S. Department of Health and Human Services. (2008). Food and drug administration. CFR—Code of Federal Regulations Title 21: Part 812—Investigational New Drug Application. Resource Document. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.62.