Swipe om te navigeren naar een ander artikel
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.
Log in om toegang te krijgen
Met onderstaand(e) abonnement(en) heeft u direct toegang:
Nunally, J., & Bernstein, I. (1994). Psychometric theory (3rd ed., p. 104). McGraw-Hill: New York.
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.
Denzin, N., & Lincoln, Y. (Eds.). (2003). Collection and interpreting qualitative materials (2nd ed.). Thousand Oaks, CA: Sage.
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.
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.
Greenhalgh, T., & Taylor, R. (1997). How to read a paper: Papers that go beyond numbers (qualitative research). British Medical Journal,315, 740–743. PubMed
Firestone, W. A., & Herriott, R. E. (1983). The formalization of qualitative research: An adaptation of “soft science” to the policy world. Evaluation Review,7, 437–466. CrossRef
Featherstone, K., & Donavan, J. L. (1998). Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial. BMJ,317, 1177–1180. PubMed
Lawton, J., Fox, A., Fox, C., & Kinmonth, A. L. (2003). Participating in the United Kingdom prospective diabetes study (UKPDS): A qualitative study of patients’ experiences. British Journal of General Practice,53, 394–398. PubMed
Madsen, S. M., Holm, S., & Riis, P. (2009). Attitudes towards clinical research among cancer trial participants and non-participants: An interview study using a grounded theory approach. Journal of Medical Ethics,33, 234–240. CrossRef
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.
Waters, E., Maher, E., Salmon, L., Reddihough, D., & Boyd, R. (2005). Development of a condition-specific measure of quality of life for children with cerebral palsy: Empirical thematic data reported by parents and children. Child: Care, Health and Development,31(2), 127–135. CrossRef
Glaser, B., & Strauss, A. (1967). The discovery of grounded theory. Chicago: Aldine Press.
Corbin, J., & Strauss, A. (1990). Grounded theory research: Procedures, canons and evaluative criteria. Qualitative Sociology,13(1), 3–21. CrossRef
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.
Patton, M. (2002). Qualitative research and evaluation methods (3rd ed.). Thousand Oaks, CA: Sage.
McGhee, G., Marland, G. R., & Atkinson, J. (2007). Grounded theory research: Literature reviewing anf reflexivity. Journal of Advanced Nursing,60(3), 334–342. PubMed
Corbin, J., & Strauss, A. (2007). Basics of qualitative research (3rd ed.). Newbury Park, CA: Sage.
Morgan, D. (1996). Focus groups. Annual Review of Sociology,22, 129–152. CrossRef
Stewart, D., Shamdasani, P. N., & Rook, D. W. (2006). Focus groups (2nd ed.). Thousand Oaks, CA: Sage.
Quine, S., & Cameron, I. (1995). The use of focus groups with the disabled elderly. Qualitative Health Research,5(4), 454–462. CrossRef
Koppelman, N., & Bourjolly, J. (2001). Conducting focus groups with women with severe psychiatric disabilities: A methodological overview. Psychiatric Rehabilitation Journal,25(2), 142–151. PubMed
Kitzinger, J. (1995). Qualitative research: Introducing focus groups. BMJ,311, 299–302. PubMed
Greenbaum, T. (2000). Moderating focus groups: A practical guide for group facilitation. Thousand Oaks, CA: Sage.
Morgan, D. (1997). Focus groups as qualitative research (2nd ed.). Thousand Oaks, CA: Sage.
Hollander, J. (2004). The social contexts of focus groups. Journal of Contemporary Ethnography,33(5), 602–637. CrossRef
Willis, G. B. (2004). Cognitive interviewing: A tool for improving questionnaire design. Thousand Oaks: Sage.
Willis, G. B. (2004). Cognitive interviewing revisited: A useful technique, in theory? In S. Presser, J. M. Rothgeb, M. P. Couper, J. T. Lessler, E. Martin, & E. Singer (Eds.), Methods for testing and evaluating survey questionnaires (pp. 23–44). New York: Wiley-IEEE. CrossRef
Beatty, P. (2004). The dynamics of cognitive interviewing. In S. Presser, J. M. Rothgeb, M. P. Couper, J. T. Lessler, E. Martin, & E. Singer (Eds.), Methods for testing and evaluating survey questionnaires (pp. 45–66). New York: Wiley-IEEE. CrossRef
Cutliffe, J. (2000). Methodological issues in grounded theory. Journal of Advanced Nursing,31(6), 1476–1484. CrossRef
Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment with data saturation and variability. Field Methods,18(1), 59–82. CrossRef
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.
Bernard, H. R. (2005). Research methods in anthropology (4th ed.). Walnut Creek, CA: Rowman Altamira.
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.
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.
Bradburn, N. M., Sudman, S., & Wansink, B. (2004). Asking questions. New York: John Wiley and Sons.
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.
Beatty, P. C., & Willis, G. B. (2007). Research synthesis: The practice of cognitive interviewing. Public Opinion Quarterly, 1–25.
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.
Krueger, R. (1995). The future of focus groups. Qualitative Health Research,5(4), 524–530. CrossRef
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.
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.
- Qualitative research and content validity: developing best practices based on science and experience
Laura E. Tesler
Torsten L. Christensen
- Springer Netherlands