Measuring dengue illness intensity: Development and content validity of the dengue virus daily diary (DENV-DD)

Journal of Patient-Reported Outcomes

Research

Charlotte Panter¹  Verity Smith¹  Amy M. Jones¹  Helen Kendal¹  Adam Gater¹  Frances White¹  Amy C. Morrison²  Valerie A. Paz-Soldan³  Michelle Klick⁴  Stephen Thomas⁴  Lisa Ware⁴  Kathryn B. Anderson⁴  Kevin Russell⁵  Madelyn Ruggieri⁵  Todd L. Saretsky⁵  Justin O’Hagan⁵  Shawna R. Calhoun⁵  Morgan A. Marks⁶  Jane R. Wells⁷ 

[1] Adelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK;Department of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, CA, USA;Department of Tropical Medicine, Tulane School of Public Health and Tropical Medicine, New Orleans, LA, USA;Institute for Global Health and Translational Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA;Merck & Co., Inc., Rahway, NJ, USA;Moderna, Cambridge, MA, USA;Sanofi, Reading, Berkshire, UK;

关键词: Clinical outcome assessment (COA);    Cognitive debriefing;    Concept elicitation;    Dengue;    Dengue human infection model (DHIM);    Observer-reported outcome (ObsRO);    Patient-reported outcome (PRO);    Qualitative;    Quantitative;   

DOI  :  10.1186/s41687-023-00624-5

 received in 2023-03-10, accepted in 2023-08-01,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDengue 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.MethodsThe 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.ResultsForty-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.ConclusionsFindings 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.

【 授权许可】

CC BY   
© International Society for Quality of Life Research (ISOQOL) 2023

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