PRO development: rigorous qualitative research as the crucial foundation

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 f...

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Published in:	Quality of life research Vol. 19; no. 8; pp. 1087 - 1096
Main Authors:	Lasch, Kathryn Eilene, Marquis, Patrick, Vigneux, Marc, Abetz, Linda, Arnould, Benoit, Bayliss, Martha, Crawford, Bruce, Rosa, Kathleen
Format:	Journal Article
Language:	English
Published:	Dordrecht Springer 01.10.2010 Springer Netherlands Springer Nature B.V
Subjects:	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 Qualitative research PRO development Grounded theory methods
ISSN:	0962-9343, 1573-2649, 1573-2649
Online Access:	Get full text
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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.
AbstractList	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. 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.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. 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.[PUBLICATION ABSTRACT]
Author	Abetz, Linda Vigneux, Marc Marquis, Patrick Rosa, Kathleen Crawford, Bruce Lasch, Kathryn Eilene Arnould, Benoit Bayliss, Martha
Author_xml	– sequence: 1 givenname: Kathryn Eilene surname: Lasch fullname: Lasch, Kathryn Eilene – sequence: 2 givenname: Patrick surname: Marquis fullname: Marquis, Patrick – sequence: 3 givenname: Marc surname: Vigneux fullname: Vigneux, Marc – sequence: 4 givenname: Linda surname: Abetz fullname: Abetz, Linda – sequence: 5 givenname: Benoit surname: Arnould fullname: Arnould, Benoit – sequence: 6 givenname: Martha surname: Bayliss fullname: Bayliss, Martha – sequence: 7 givenname: Bruce surname: Crawford fullname: Crawford, Bruce – sequence: 8 givenname: Kathleen surname: Rosa fullname: Rosa, Kathleen
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/20512662$$D View this record in MEDLINE/PubMed
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Snippet	Recently published articles have described criteria to assess qualitative research in the health field in general, but very few articles have delineated...
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SubjectTerms	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
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Title	PRO development: rigorous qualitative research as the crucial foundation
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