Evidence map›Paper›PMID 37610665›Full record

ArticleJournal of patient-reported outcomes2023

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

Amy M Jones, Todd L Saretsky, Charlotte Panter, Jane R Wells, Frances White, Verity Smith, Helen Kendal, Kevin Russell, Madelyn Ruggieri, Shawna R Calhoun and 9 more

Abstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Amy M JonesAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK. Amy.Jones@adelphivalues.com.ORCID http://orcid.org/0000-0003-3645-746X
Todd L SaretskyMerck & Co., Inc., Rahway, NJ, USA.
Charlotte PanterAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK.
Jane R WellsSanofi, Reading, Berkshire, UK.
Frances WhiteAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK.
Verity SmithAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK.
Helen KendalAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK.
Kevin RussellMerck & Co., Inc., Rahway, NJ, USA.
Madelyn RuggieriMerck & Co., Inc., Rahway, NJ, USA.
Shawna R CalhounMerck & Co., Inc., Rahway, NJ, USA.
Adam GaterAdelphi Values Ltd., Patient Centered Outcomes, Cheshire, UK.
Justin O'HaganMerck & Co., Inc., Rahway, NJ, USA.
Kathryn B AndersonInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.
Valerie A Paz-SoldanDepartment of Tropical Medicine, Tulane School of Public Health and Tropical Medicine, New Orleans, LA, USA.
Amy C MorrisonDepartment of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, CA, USA.
Lisa WareInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.
Michelle KlickInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.
Stephen ThomasInstitute for Global Health and Translational Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.
Morgan A MarksModerna, Cambridge, MA, USA.

Funding

Surveillance Core (B)P01AI098670 · NIAID · UNIVERSITY OF CALIFORNIA AT DAVIS · PI SCOTT, THOMAS WALLACE · 2014 to 2018
$7.9M
NIAID NIH HHS P01 AI098670
6 · The paper itself

Abstract

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.

Indexed as

CardiologyDengueDengue VirusAdolescentAdultAppetiteChildCost of IllnessHumansInfantPainClinical outcome assessment (COA)Cognitive debriefingConcept elicitationDengueDengue human infection model (DHIM)Observer-reported outcome (ObsRO)Patient-reported outcome (PRO)QualitativeQuantitative

Identifiers

PMID37610665
PMCPMC10447358

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.