Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD)
Abstract Background Dengue is the most prevalent arboviral infection causing an estimated 50–60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment,...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2023-08-01
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| Series: | Journal of Patient-Reported Outcomes |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41687-023-00624-5 |
| _version_ | 1797452421071372288 |
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| author | Amy M. Jones Todd L. Saretsky Charlotte Panter Jane R. Wells Frances White Verity Smith Helen Kendal Kevin Russell Madelyn Ruggieri Shawna R. Calhoun Adam Gater Justin O’Hagan Kathryn B. Anderson Valerie A. Paz-Soldan Amy C. Morrison Lisa Ware Michelle Klick Stephen Thomas Morgan A. Marks |
| author_facet | Amy M. Jones Todd L. Saretsky Charlotte Panter Jane R. Wells Frances White Verity Smith Helen Kendal Kevin Russell Madelyn Ruggieri Shawna R. Calhoun Adam Gater Justin O’Hagan Kathryn B. Anderson Valerie A. Paz-Soldan Amy C. Morrison Lisa Ware Michelle Klick Stephen Thomas Morgan A. Marks |
| author_sort | Amy M. Jones |
| collection | DOAJ |
| description | Abstract Background Dengue is the most prevalent arboviral infection causing an estimated 50–60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel ‘Dengue Virus Daily Diary (DENV-DD)’, designed to measure symptom intensity and disease burden within outpatient infant to adult populations. Methods The Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness. Results Forty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3–15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion. Conclusions Findings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies. |
| first_indexed | 2024-03-09T15:08:31Z |
| format | Article |
| id | doaj.art-184c2e4578e846c188f7230c30975c5c |
| institution | Directory Open Access Journal |
| issn | 2509-8020 |
| language | English |
| last_indexed | 2024-03-09T15:08:31Z |
| publishDate | 2023-08-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Journal of Patient-Reported Outcomes |
| spelling | doaj.art-184c2e4578e846c188f7230c30975c5c2023-11-26T13:29:37ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202023-08-017111810.1186/s41687-023-00624-5Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD)Amy M. Jones0Todd L. Saretsky1Charlotte Panter2Jane R. Wells3Frances White4Verity Smith5Helen Kendal6Kevin Russell7Madelyn Ruggieri8Shawna R. Calhoun9Adam Gater10Justin O’Hagan11Kathryn B. Anderson12Valerie A. Paz-Soldan13Amy C. Morrison14Lisa Ware15Michelle Klick16Stephen Thomas17Morgan A. Marks18Adelphi Values Ltd., Patient Centered OutcomesMerck & Co., Inc.Adelphi Values Ltd., Patient Centered OutcomesSanofiAdelphi Values Ltd., Patient Centered OutcomesAdelphi Values Ltd., Patient Centered OutcomesAdelphi Values Ltd., Patient Centered OutcomesMerck & Co., Inc.Merck & Co., Inc.Merck & Co., Inc.Adelphi Values Ltd., Patient Centered OutcomesMerck & Co., Inc.Institute for Global Health and Translational Sciences, State University of New York, Upstate Medical UniversityDepartment of Tropical Medicine, Tulane School of Public Health and Tropical MedicineDepartment of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of CaliforniaInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical UniversityInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical UniversityInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical UniversityModernaAbstract Background Dengue is the most prevalent arboviral infection causing an estimated 50–60 million cases of febrile illness globally per year, exacting considerable disease burden. Few instruments exist to assess the patient illness experience, with most based on healthcare provider assessment, lacking standardization in timepoints and symptom assessment. This study aimed to evaluate the content validity of the novel ‘Dengue Virus Daily Diary (DENV-DD)’, designed to measure symptom intensity and disease burden within outpatient infant to adult populations. Methods The Dengue Illness Index Report Card was used as a foundation to create the DENV-DD, consisting of patient- and observer-reported outcome (PRO/ObsRO) instruments. In two South American dengue-endemic communities, qualitative combined concept elicitation and cognitive debriefing interviews were conducted among individuals and caregivers of children with symptomatic laboratory-confirmed dengue. Interviews were conducted across two rounds allowing DENV-DD modifications. A small-scale quantitative assessment of the DENV-DD was also conducted with data from an independent Dengue Human Infection Model (DHIM) to generate early evidence of feasibility of DENV-DD completion, instrument performance and insight into the sign/symptom trajectory over the course of illness. Results Forty-eight participants were interviewed (20 adults, 20 older children/adolescents with their caregivers, 8 caregivers of younger children). A wide spectrum of signs/symptoms lasting 3–15 days were reported with fever, headache, body ache/pain, loss of appetite, and body weakness each reported by > 70% participants. DENV-DD instructions, items and response scales were understood, and items were considered relevant across ages. DHIM data supported feasibility of DENV-DD completion. Conclusions Findings demonstrate content validity of the DENV-DD (PRO/ObsRO instruments) in dengue-endemic populations. Psychometric and cultural validity studies are ongoing to support use of the DENV-DD in clinical studies.https://doi.org/10.1186/s41687-023-00624-5Clinical outcome assessment (COA)Cognitive debriefingConcept elicitationDengueDengue human infection model (DHIM)Observer-reported outcome (ObsRO) |
| spellingShingle | Amy M. Jones Todd L. Saretsky Charlotte Panter Jane R. Wells Frances White Verity Smith Helen Kendal Kevin Russell Madelyn Ruggieri Shawna R. Calhoun Adam Gater Justin O’Hagan Kathryn B. Anderson Valerie A. Paz-Soldan Amy C. Morrison Lisa Ware Michelle Klick Stephen Thomas Morgan A. Marks Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) Journal of Patient-Reported Outcomes Clinical outcome assessment (COA) Cognitive debriefing Concept elicitation Dengue Dengue human infection model (DHIM) Observer-reported outcome (ObsRO) |
| title | Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) |
| title_full | Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) |
| title_fullStr | Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) |
| title_full_unstemmed | Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) |
| title_short | Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD) |
| title_sort | measuring dengue illness intensity development and content validity of the dengue virus daily diary denv dd |
| topic | Clinical outcome assessment (COA) Cognitive debriefing Concept elicitation Dengue Dengue human infection model (DHIM) Observer-reported outcome (ObsRO) |
| url | https://doi.org/10.1186/s41687-023-00624-5 |
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