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Quality of Life Research
Published in: Quality of Life Research 8/2010

Open Access 01-10-2010

PRO development: rigorous qualitative research as the crucial foundation

Authors: Kathryn Eilene Lasch, Patrick Marquis, Marc Vigneux, Linda Abetz, Benoit Arnould, Martha Bayliss, Bruce Crawford, Kathleen Rosa

Published in: Quality of Life Research | Issue 8/2010

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Abstract

Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated qualitative methods to be used in the development of Patient-Reported Outcomes (PROs). In fact, how PROs are developed with subject input through focus groups and interviews has been given relatively short shrift in the PRO literature when compared to the plethora of quantitative articles on the psychometric properties of PROs. If documented at all, most PRO validation articles give little for the reader to evaluate the content validity of the measures and the credibility and trustworthiness of the methods used to develop them. Increasingly, however, scientists and authorities want to be assured that PRO items and scales have meaning and relevance to subjects. This article was developed by an international, interdisciplinary group of psychologists, psychometricians, regulatory experts, a physician, and a sociologist. It presents rigorous and appropriate qualitative research methods for developing PROs with content validity. The approach described combines an overarching phenomenological theoretical framework with grounded theory data collection and analysis methods to yield PRO items and scales that have content validity.
Literature
1.
Patrick, D., Rock, E., O’Neill, R., Powers, J., Scott, J., Kennedy, D., et al. (2007). Patient reported outcomes to support medical product labelling claims: FDA perspective. Value in Health, 10, 125–137.CrossRef
2.
McColl, E. (2005). Developing Questionnaires. In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials (2nd ed., pp. 9–23). Oxford UK: Oxford University Press.
3.
Sireci, S. G. (1998). The construct of content validity. Social Indicators Research, 45, 83–117.CrossRef
4.
Ware, J. E, Jr, Keller, S. D., Hatoum, H. T., & Kong, S. X. (1999). The SF-36 arthritis-specific health index (ASHI): I. Development and cross-validation of scoring algorithms. Medical Care, 37(5 Suppl), MS40–MS50.CrossRefPubMed
5.
Meyrick, J. (2007). What is good qualitative research? A first step towards a comprehensive approach to judging rigorous quality. Journal of Health Psychology, 11(5), 799–808.CrossRef
6.
US Department of Health and Human Services. (2009). Guidance for industry patient-reported outcome measures: Use in Medical Product Development to Suppor Labelling Claims.
7.
Revicki, D. A., & Regulatory Issues and Patient-Reported Outcomes Task Force for the International Society for Quality of Life Research. (2007). FDA draft guidance and health-outcomes research. Lancet, 369(9561), 540–542.CrossRefPubMed
8.
9.
Presser, S., Rothgeb, J. M., Martin, J., Singer, E., Lessler, J. T., & Martin, E. (2004). Methods for testing and evaluating survey questionnaires. Public Opinion Quarterly, 68, 109–130.CrossRef
10.
Tourangeau, R. (2000). Impact of cognitive models on survey measurement. In R. Tourangeau, L. J. Rips, & K. Rasinski (Eds.), The psychology of survey response (pp. 313–343). Cambridge, UK: Cambridge University Press.
11.
Willis, G. (2005). Cognitive interviewing in practice. In Cognitive. Interviewing (Ed.), A tool for improving questionnaire design (pp. 42–62). Thousand Oaks, CA: Sage Publishers.
12.
Kitzinger, J. (1995). Qualitative research. Introducing focus groups. BMJ, 311(7000), 299–302.PubMed
13.
Pope, C., Ziebland, S., & Mays, N. (2000). Qualitative research in health care. Analysing qualitative data. BMJ, 320(7227), 114–116.CrossRefPubMed
14.
15.
Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. International Journal of Quality in Health Care, 19(6), 349–357.CrossRef
16.
Acquadro, C., Berzon, R., Dubois, D., Leidy, N. K., Marquis, P., Revicki, D., et al. (2003). Incorporating the patient’s perspective into drug development and communication: An ad hoc task force report of the patient-reported outcomes (PRO) Harmonization group meeting at the food and drug administration, February 16, 2001. Value in Health, 6(5), 522–531.CrossRefPubMed
17.
Leidy, N. K. (2006). Evolving concepts in the measurement of treatment effects. Proceedings of the American Thoracic Society, 3(3), 212–217.CrossRefPubMed
18.
Crabtree, B. F., & Miller, W. L. (1992). Doing qualitative research: Research methods for primary care. London: Sage Publications.
19.
Sandelowski, M. (2004). Using qualitative research. Qualitative Health Research, 14(10), 1366–1386.CrossRefPubMed
20.
Banister, P., Burman, E., Parker, I., Taylor, M., & Tindall, C. (2006). Qualiative methods in psychology: A research guide. Berkshire, UK: Open University Press.
21.
Charmaz, K. (1995). Grounded theory. In J. A. Smith, R. Harre, & L. Van Langenhove (Eds.), Rethinking methods in psychology (pp. 27–49). London: Sage.
22.
Shaw, R. (2001). Why use interpretative phenomenological analysis in health psychology? Health Psychology Update, 10(4), 48–52.
23.
Smith, J. A., Harre, R., & Van Langenhove, L. (2005). Rethinking methods in psychology. London: SAGE Publications.
24.
Collins, D. (2003). Pretesting survey instruments: An overview of cognitive methods. Quality of Life Research, 12(3), 229–238.CrossRefPubMed
25.
Podsakoff, P. M., MacKenzie, S. B., Lee, J. Y., & Podsakoff, N. P. (2003). Common method biases in behavioral research: A critical review of the literature and recommended remedies. Journal of Applied Psychology, 88(5), 879–903.CrossRefPubMed
26.
Schaeffer, N., & Presser, S. (2003). The science of asking questions. Annual Review of Sociology, 29, 65–88.CrossRef
27.
Tourangeau, R. (2000). Respondents’ understanding of survey questions. In R. Tourangeau, L. J. Rips, & K. Rasinski (Eds.), The psychology of survey response (pp. 23–61). Cambridge, UK: Cambridge University Press.
28.
Tourangeau, R. (2000). Factual judgments and numerical estimates. In R. Tourangeau, L. J. Rips, & K. Rasinski (Eds.), The psychology of survey response (pp. 135–164). Cambridge, UK: Cambridge University Press.
29.
Tourangeau, R. (1984). Cognitive science and survey methods. In T. Jabine, M. Straf, J. Tanur, & R. Tourangeau (Eds.), Cognitive aspects of survey design: Building a bridge between disciplines (pp. 73–100). Washington, D.C.: National Academy Press.
30.
Armes, J., Krishnasamy, M., & Higginson, I. (2004). Fatigue in cancer. Oxford, UK: Oxford University Press.
31.
Dixon-Woods, M., Shaw, R. L., Agarwal, S., & Smith, J. A. (2004). The problem of appraising qualitative research. Quality & Safety in Health Care, 13(3), 223–225.CrossRef
32.
Wu, H. S., & McSweeney, M. (2004). Assessing fatigue in persons with cancer: An instrument development and testing study. Cancer, 101(7), 1685–1695.CrossRefPubMed
33.
Liamputtong, P., & Ezzy, D. (2005). Qualitative research methods (2nd ed. ed.). Melbourne, Australia: Oxford University Press.
34.
Schwartz, C., Sprangers, M. A., & Fayers, P. (2005). Response shift: You know it’s there, but how do you capture it? Challenges for the next phase of research. In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials (2nd ed., pp. 275–290). Oxford: Oxford University Press.
35.
Girot, E. A. (1993). Assessment of competence in clinical practice: A phenomenological approach. Journal of Advanced Nursing, 18(1), 114–119.CrossRefPubMed
36.
Glaser, B. G., & Strauss, A. (1967). The discovery of grounded theory: Strategies for qualitative research. Chicago: Aldine.
37.
Strauss, A., & Corbin, J. (1998). Basics of qualitative research: Techniques and procedures for developing grounded theory (2nd ed. ed.). London: Sage.
38.
Sandelowski. (7-16-2000). 5th Annual Summer Institute in Qualitative Research, University of North Carolina School of Nursing, Chapel Hill, NC.
39.
Charmaz, K. (1991). Good days, bad days: The self in chronic illness and time. New Brunswick, NJ: Rutgers University Press.
40.
Bowen, G. A. (2006). Grounded theory and sensitizing concepts. International Journal of Qualitative Methods, 5(3), 12–23.
41.
Weitzman, E. A., & Miles, M. B. (1995). Computer programs for qualitative data analysis. London: Sage Publications.
42.
Miles, M. B., & Huberman, A. M. (1994). Qualitative data analysis. London: Sage Publications.
43.
Morse, J. M. (1995). The significance of saturation. Qualitative Health Research, 5(2), 147–149.CrossRef
44.
Golafshani, N. (2003). Understanding reliability and validity in qualitative research. The Qualitative Report, 8(4), 597–607.
45.
Sandelowski, M. (2000). Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Research in Nursing and Health, 23(3), 246–255.CrossRefPubMed
46.
Kirk, J., & Miller, M. L. (1986). Reliability and validity in qualitative research. London: Sage.
47.
Patton, M. Q. (2002). Qualitative research & evaluation methods (3rd ed.). London: Sage Publications, Inc.
48.
Denzin, N. K., & Lincoln, Y. S. (1994). Handbook of qualitative research. London: Sage Publications, Inc.
49.
Metadata
Title
PRO development: rigorous qualitative research as the crucial foundation
Authors
Kathryn Eilene Lasch
Patrick Marquis
Marc Vigneux
Linda Abetz
Benoit Arnould
Martha Bayliss
Bruce Crawford
Kathleen Rosa
Publication date
01-10-2010
Publisher
Springer Netherlands
Published in
Quality of Life Research / Issue 8/2010
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-010-9677-6

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