Failure to reach data saturation has an impact on the quality of the research conducted and hampers content validity. The aim of a study should include what determines when data saturation is achieved, for a small study will reach saturation more rapidly than a larger study. Data saturation is reached when there is enough information to replicate the study when the ability to obtain additional new information has been attained, and when further coding is no longer feasible. The following article critiques two qualitative studies for data saturation: Wolcott (2004) and Landau and Drori (2008). Failure to reach data saturation has a negative impact on the validity on one’s research. The intended audience is novice student researchers. Keywords: Data Saturation, Triangulation, Interviews, Personal Lens, Bias.

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Are We There Yet? Data Saturation in Qualitative Research

Content Validity—Establishing and Reporting the Evidence in Newly Developed Patient-Reported Outcomes (PRO) Instruments for Medical Product Evaluation: ISPOR PRO Good Research Practices Task Force Report: Part 1—Eliciting Concepts for a New PRO Instrument

https://digitalcommons.wayne.edu/cgi/viewcontent.cgi?article=1259&context=csr

Good Days, Bad Days: The Self in Chronic Illness and Time

Qualitative Methods in Psychology: A Research Guide.

Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients.

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.

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Marc Vigneux

Papers

PRO development: rigorous qualitative research as the crucial foundation