Journal Article

PRO development: rigorous qualitative research as the crucial foundation

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

2010

Overview

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.

• Publisher: Springer,Springer Netherlands,Springer Nature B.V
• Subject: Clinical outcomes / Clinical trials / Cognitive psychology / Conceptual frameworks / Content validity / Data collection / Data Collection - methods / Focus groups / Grounded theory / Grounded theory method / Health / Interdisciplinary aspects / Interviews / Medical research / Medicine / Medicine & Public Health / Observational research / Outcome Assessment, Health Care - methods / Patients / Psychological research / Psychologists / Psychometrics / Public Health / QUALITATIVE RESEARCH / Quality of Life Research / Quantitative psychology / Questionnaires / Research methodology / Research methods / Sociology / Validation Studies as Topic / Validity