Cargando…
The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis
BACKGROUND: Patients with cystic fibrosis (CF) experience significant disease burden, including progressive pulmonary decline and reduced survival. This multicenter qualitative study was conducted to develop a new patient-reported outcome (PRO) measure to assess the impact of CF on patients’ quality...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221045/ https://www.ncbi.nlm.nih.gov/pubmed/32405878 http://dx.doi.org/10.1186/s41687-020-00199-5 |
_version_ | 1783533286862094336 |
---|---|
author | McCarrier, Kelly P. Hassan, Mariam Hodgkins, Paul Suthoff, Ellison McGarry, Lisa J. Martin, Mona L. |
author_facet | McCarrier, Kelly P. Hassan, Mariam Hodgkins, Paul Suthoff, Ellison McGarry, Lisa J. Martin, Mona L. |
author_sort | McCarrier, Kelly P. |
collection | PubMed |
description | BACKGROUND: Patients with cystic fibrosis (CF) experience significant disease burden, including progressive pulmonary decline and reduced survival. This multicenter qualitative study was conducted to develop a new patient-reported outcome (PRO) measure to assess the impact of CF on patients’ quality of life: the Cystic Fibrosis Impact Questionnaire (CF-IQ). Semi-structured qualitative concept elicitation (CE) interviews with patients and caregivers documented CF-related symptoms, impacts, and treatment experiences. Coded interview data were considered alongside existing PROs, published literature, and expert opinion to develop an initial scale. Three rounds of cognitive interviews evaluated respondent comprehension and facilitated refinement of the CF-IQ. RESULTS: Adult (N = 20) and pediatric (N = 22) patients with CF and their parents/caregivers (N = 22) completed CE interviews at 7 US clinics. The sample included patients aged 6–58 years, 57% females, and represented a broad range of disease severity (forced expiratory volume in 1 s range: 22%–127% predicted). Interviews identified 59 unique CF-related impact concepts in domains, including activity limitations (physical, social, leisure), functional limitations (school, work), vulnerability/lack of control, emotional impact, treatment burden, and future outlook. Concept saturation was achieved, and a draft questionnaire was developed. Findings from the cognitive interviews (n = 18) confirmed that instructions, items, and response scales were relevant and clear, and interpreted as intended by patients. CONCLUSION: The CF-IQ is a 40-item novel PRO scale assessing a comprehensive set of patient-relevant concepts to characterize the multifaceted nature of CF. Qualitative interview data support the content validity of the CF-IQ, which is currently undergoing additional psychometric evaluation in patients with CF. |
format | Online Article Text |
id | pubmed-7221045 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-72210452020-05-15 The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis McCarrier, Kelly P. Hassan, Mariam Hodgkins, Paul Suthoff, Ellison McGarry, Lisa J. Martin, Mona L. J Patient Rep Outcomes Research BACKGROUND: Patients with cystic fibrosis (CF) experience significant disease burden, including progressive pulmonary decline and reduced survival. This multicenter qualitative study was conducted to develop a new patient-reported outcome (PRO) measure to assess the impact of CF on patients’ quality of life: the Cystic Fibrosis Impact Questionnaire (CF-IQ). Semi-structured qualitative concept elicitation (CE) interviews with patients and caregivers documented CF-related symptoms, impacts, and treatment experiences. Coded interview data were considered alongside existing PROs, published literature, and expert opinion to develop an initial scale. Three rounds of cognitive interviews evaluated respondent comprehension and facilitated refinement of the CF-IQ. RESULTS: Adult (N = 20) and pediatric (N = 22) patients with CF and their parents/caregivers (N = 22) completed CE interviews at 7 US clinics. The sample included patients aged 6–58 years, 57% females, and represented a broad range of disease severity (forced expiratory volume in 1 s range: 22%–127% predicted). Interviews identified 59 unique CF-related impact concepts in domains, including activity limitations (physical, social, leisure), functional limitations (school, work), vulnerability/lack of control, emotional impact, treatment burden, and future outlook. Concept saturation was achieved, and a draft questionnaire was developed. Findings from the cognitive interviews (n = 18) confirmed that instructions, items, and response scales were relevant and clear, and interpreted as intended by patients. CONCLUSION: The CF-IQ is a 40-item novel PRO scale assessing a comprehensive set of patient-relevant concepts to characterize the multifaceted nature of CF. Qualitative interview data support the content validity of the CF-IQ, which is currently undergoing additional psychometric evaluation in patients with CF. Springer International Publishing 2020-05-13 /pmc/articles/PMC7221045/ /pubmed/32405878 http://dx.doi.org/10.1186/s41687-020-00199-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Research McCarrier, Kelly P. Hassan, Mariam Hodgkins, Paul Suthoff, Ellison McGarry, Lisa J. Martin, Mona L. The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title | The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title_full | The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title_fullStr | The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title_full_unstemmed | The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title_short | The Cystic Fibrosis Impact Questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
title_sort | cystic fibrosis impact questionnaire: qualitative development and cognitive evaluation of a new patient-reported outcome instrument to assess the life impacts of cystic fibrosis |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221045/ https://www.ncbi.nlm.nih.gov/pubmed/32405878 http://dx.doi.org/10.1186/s41687-020-00199-5 |
work_keys_str_mv | AT mccarrierkellyp thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT hassanmariam thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT hodgkinspaul thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT suthoffellison thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT mcgarrylisaj thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT martinmonal thecysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT mccarrierkellyp cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT hassanmariam cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT hodgkinspaul cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT suthoffellison cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT mcgarrylisaj cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis AT martinmonal cysticfibrosisimpactquestionnairequalitativedevelopmentandcognitiveevaluationofanewpatientreportedoutcomeinstrumenttoassessthelifeimpactsofcysticfibrosis |