PRO development: rigorous qualitative research as the crucial foundation
Kathryn Lasch,Patrick Marquis,Marc Vigneux,Linda Abetz,Benoit Arnould,Martha S. Bayliss,Bruce Crawford,Kathleen Rosa +7 more
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TLDR
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.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.read more
Citations
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Are We There Yet? Data Saturation in Qualitative Research
TL;DR: 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 as mentioned in this paper.
Journal ArticleDOI
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
Donald L. Patrick,Laurie B. Burke,Chad J. Gwaltney,Nancy Kline Leidy,Mona L. Martin,Elizabeth Molsen,Lena Ring +6 more
TL;DR: Suggestions for good practices in planning, executing, and documenting qualitative studies that are used to support the content validity of PRO instruments to be used in medical product evaluation are offered.
Journal ArticleDOI
Qualitative Methods in Psychology: A Research Guide.
Terri Gullickson,Pamela Ramser +1 more
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Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients.
TL;DR: The FACE-Q instrument as discussed by the authors is a suite of independently functioning scales designed to measure a range of important outcomes for facial aesthetics patients, including satisfaction with appearance and improved quality of life.
References
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Book
Discovery of Grounded Theory: Strategies for Qualitative Research
TL;DR: The Discovery of Grounded Theory as mentioned in this paper is a book about the discovery of grounded theories from data, both substantive and formal, which is a major task confronting sociologists and is understandable to both experts and laymen.
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Common method biases in behavioral research: a critical review of the literature and recommended remedies.
TL;DR: The extent to which method biases influence behavioral research results is examined, potential sources of method biases are identified, the cognitive processes through which method bias influence responses to measures are discussed, the many different procedural and statistical techniques that can be used to control method biases is evaluated, and recommendations for how to select appropriate procedural and Statistical remedies are provided.
Journal ArticleDOI
The Discovery of Grounded Theory: Strategies for Qualitative Research.
Book
Basics of qualitative research : techniques and procedures for developing grounded theory
TL;DR: Theoretical Foundations and Practical Considerations for Getting Started and Techniques for Achieving Theoretical Integration are presented.
Journal ArticleDOI
Handbook of Qualitative Research
TL;DR: The discipline and practice of qualitative research have been extensively studied in the literature as discussed by the authors, including the work of Denzin and Denzin, and their history in sociology and anthropology, as well as the role of women in qualitative research.