2,238
Views
281
CrossRef citations to date
0
Altmetric
Review

Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research

, &
Pages 269-281 | Published online: 09 Jan 2014

References

  • Patrick DL, Burke LB, Powers JH et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health10(2), S125–S137 (2007).
  • Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes: conceptual issues. Value Health10(Suppl. 2), S66–S75 (2007).
  • Kline Leidy N, Vernon M. Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. Pharmacoeconomics26(5), 363–370 (2008).
  • US Department of Health and Human Services Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Guidance for industry: patient-reported outcome measures: use in medicinal product development to support labeling claims: draft guidance. Health Qual. Life Outcomes4, 79 (2006).
  • Burke LB, Kennedy DL, Miskala PH, Papdopoulos EJ, Trentacosti AM. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin. Pharmacol. Ther.84(2), 281–283 (2008).
  • Braun V, Clarke V. Using thematic analysis in psychology. Qual. Res. Psychology3, 77–101 (2006).
  • Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual. Life Res.18, 1263–1278 (2009).
  • Caelli K, Ray L, Mill J. Clear and mud: toward greater clarity in generic qualitative research. Int. J. Qual. Methods2(2), 1–13 (2003).
  • Yardley L, Marks DF. Introduction to research methods in clinical and health psychology. In: Research Methods for Clinical and Health Psychology. Marks D, Yardley L (Eds). SAGE Publications Ltd, London, UK 1–20 (2004).
  • Wilkinson S, Joffe H, Yardley L. Qualitative data collection: interviews and focus groups. In: Research Methods for Clinical and Health Psychology. Marks D, Yardley L (Eds). SAGE Publications Ltd, London, UK 39–55 (2004).
  • Fallowfield L. The Quality of Life: The Missing Measurement in Healthcare. Souvenir Press (Educational & Academic), London, UK (1990).
  • Rapley M. Quality of Life Research: A Critical Introduction. SAGE Publications Ltd, London, UK (2003).
  • Rothman M, Burke L, Erickson P, Kline Leidy N, Patrick DL, Petrie C. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR good research practices for evaluating and documenting content validity for the use of existing instruments and their modification PRO task force report. Value Health12(8), 1075–1083 (2009).
  • Turner RR, Quittner AL, Parasuraman BM, Kallich JD, Cleeland CS; Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. Patient-reported outcomes: instrument development and selection issues. Value Health10(2), S86–S93 (2007).
  • Wild D, Grove A, Martin M et al. Principles of good practice for the translation and cultural adaptation process for patient reported outcomes (PRO) measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health8(2), 94–104 (2005).
  • Coons SJ, Gwaltney CJ, Hays RD et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health12(4), 419–429 (2009).
  • Adair CE, Marcoux G, Williams A, Reimer M. The internet as a source of data to support the development of a quality-of-life measure for eating disorders. Qual. Health Res.16, 538–546 (2006).
  • Yardley L, Bishop F. Mixing qualitative and quantitative methods: a pragmatic approach. In: The SAGE Handbook Of Qualitative Research In Psychology. Willig C, Stainton-Rogers W (Eds.). SAGE Publications Ltd, London, UK 352–369 (2007).
  • Morse JM, Barrett M, Mayan M, Olson K, Spiers J. Verification strategies for establishing reliability and validity in qualitative research. Int. J. Qual. Methods1(2), 13–22 (2002).
  • Whittemore R, Chase SK, Mandle CL. Validity in qualitative research. Qual. Health Res.11, 522–537 (2001).
  • Yardley L. Dilemmas in qualitative health research. Psychol. Health15(2), 215–228 (2000).
  • Yardley L. Demonstrating validity in qualitative psychology. In: Qualitative Psychology: A Practical Guide To Research Methods. Smith J (Ed.). SAGE Publications Ltd, London, UK 235–251 (2008).
  • Morse JM. The significance of saturation. Qual. Health Res.5(2), 147–149 (1995).
  • Sandelowski M. Sample size in qualitative research. Res. Nurs. Health18(2), 179–183 (1995).
  • Bowen GA. Naturalistic inquiry and the saturation concept: a research note. Qual. Res.8, 137–152 (2008).
  • Glaser BG, Strauss A. Discovery of Grounded Theory. Strategies for Qualitative Research. Wiedenfield and Nicolson, London, UK (1967).
  • Strauss A, Corbin J. Grounded theory methodology: an overview. In: Handbook of Qualitative Research. Denzin N, Lincoln Y (Eds). SAGE Publications Ltd, CA, USA 273–285 (1994).
  • Marshall MN. Sampling for qualitative research. Family Practice13, 522–525 (1996).
  • Morse J. Determining sample size. Qual. Health Res.10, 3–5 (2000).
  • Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods18(1), 59–82 (2006).
  • Onwuegbuzie AJ, Leech N. A call for qualitative power analyses. Qual. Quant.41, 105–121 (2007).
  • Morse J. Silent debates in qualitative enquiry. Qual. Health Res.9, 163–165 (1999).
  • MacQueen KM, McLellan E, Kay K, Niedig J. Codebook development for team-based qualitative analysis. Cultural Anthropology Methods J.10(12), 31–36 (1998).
  • Gallop K, Wild D, Verdian L et al. Lennox-Gastaut syndrome (LGS): development of conceptual models of health-related quality of life (HRQL) for caregivers and children. Seizure19, 23–30 (2010).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.