Core outcome measurement set for clinical trials in dengue: an international Delphi consensus study (DEN-CORE)
1
Issued Date
2025-01-01
Resource Type
ISSN
14733099
eISSN
14744457
Scopus ID
2-s2.0-105020864904
Pubmed ID
41072450
Journal Title
Lancet Infectious Diseases
Rights Holder(s)
SCOPUS
Bibliographic Citation
Lancet Infectious Diseases (2025)
Suggested Citation
Yacoub S., Demidova A., Chan X.H.S., Ajam A., Baimukhambetova D., Horn A., Kakotkina E., Kosenko M., Mursalova A., Van Nuil J.I., Phuong C.L., Xiao L., Adhikari S., Alzate Alvarez J.D., Anderson K.B., Avirutnan P., Buchholz S., Chandra R., Chang A.Y., Quang Chanh H., Consuegra Rodríguez M.P., Daniel V., Diaz J.V., Figueiredo-Mello C., Gelvez-Ramírez R.M., Huyen T.B., Kestelyn E., Lam P.K., Leopold S.J., Li R., Luu T., Lye D.C.B., McBride A., Meyer-Andrieux I., Moorman N.J., Nguyen N.M., Omar S.F.S., Ong H.C., Ooi E.E., Pazukhina E., Pett S.L., Porto D.B., Rajahram G.S., Rogers M., Rojas E., Rosen J., Rylance J., Schilling W.H.K., Siqueira A.M., Sjö P., Sucerquia-Hernandez A., Tam D.T.H., Teixeira M.M., Tietz A., Trieu H.T., Unsworth A., Villar L., Waickman A.T., Watson J.A., Wills B.A., Chia P.Y., Brasil P., Jaenisch T., Lum L., Malavige G.N., McGloughlin S., Tirupakuzhi Vijayaraghavan B.K., Merson L., Munblit D., Ab Wahab S., Adhikari N.K., Ahmed M.J., Arguni E., Aryal D., Bakri A., SL Bastos L., Bhusal S., Blanco L., Caoili J., Celis-Salinas J.C., Chaiwang S., Chesnokov A., Claure-Del Granado R., Cruz Y.V., Dahal A., Dewi R., Fareed K., Felipe Reyes L., Hashmi M., Jayadas T.T., Joshi M., Karunananda M.V., Katzelnick L.C., Kevin M., Lee S.W., Leo Y.S., M N., Marshall J., Mazlan M.Z., Mustafa A. Core outcome measurement set for clinical trials in dengue: an international Delphi consensus study (DEN-CORE). Lancet Infectious Diseases (2025). doi:10.1016/S1473-3099(25)00500-6 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/113030
Title
Core outcome measurement set for clinical trials in dengue: an international Delphi consensus study (DEN-CORE)
Author(s)
Yacoub S.
Demidova A.
Chan X.H.S.
Ajam A.
Baimukhambetova D.
Horn A.
Kakotkina E.
Kosenko M.
Mursalova A.
Van Nuil J.I.
Phuong C.L.
Xiao L.
Adhikari S.
Alzate Alvarez J.D.
Anderson K.B.
Avirutnan P.
Buchholz S.
Chandra R.
Chang A.Y.
Quang Chanh H.
Consuegra Rodríguez M.P.
Daniel V.
Diaz J.V.
Figueiredo-Mello C.
Gelvez-Ramírez R.M.
Huyen T.B.
Kestelyn E.
Lam P.K.
Leopold S.J.
Li R.
Luu T.
Lye D.C.B.
McBride A.
Meyer-Andrieux I.
Moorman N.J.
Nguyen N.M.
Omar S.F.S.
Ong H.C.
Ooi E.E.
Pazukhina E.
Pett S.L.
Porto D.B.
Rajahram G.S.
Rogers M.
Rojas E.
Rosen J.
Rylance J.
Schilling W.H.K.
Siqueira A.M.
Sjö P.
Sucerquia-Hernandez A.
Tam D.T.H.
Teixeira M.M.
Tietz A.
Trieu H.T.
Unsworth A.
Villar L.
Waickman A.T.
Watson J.A.
Wills B.A.
Chia P.Y.
Brasil P.
Jaenisch T.
Lum L.
Malavige G.N.
McGloughlin S.
Tirupakuzhi Vijayaraghavan B.K.
Merson L.
Munblit D.
Ab Wahab S.
Adhikari N.K.
Ahmed M.J.
Arguni E.
Aryal D.
Bakri A.
SL Bastos L.
Bhusal S.
Blanco L.
Caoili J.
Celis-Salinas J.C.
Chaiwang S.
Chesnokov A.
Claure-Del Granado R.
Cruz Y.V.
Dahal A.
Dewi R.
Fareed K.
Felipe Reyes L.
Hashmi M.
Jayadas T.T.
Joshi M.
Karunananda M.V.
Katzelnick L.C.
Kevin M.
Lee S.W.
Leo Y.S.
M N.
Marshall J.
Mazlan M.Z.
Mustafa A.
Demidova A.
Chan X.H.S.
Ajam A.
Baimukhambetova D.
Horn A.
Kakotkina E.
Kosenko M.
Mursalova A.
Van Nuil J.I.
Phuong C.L.
Xiao L.
Adhikari S.
Alzate Alvarez J.D.
Anderson K.B.
Avirutnan P.
Buchholz S.
Chandra R.
Chang A.Y.
Quang Chanh H.
Consuegra Rodríguez M.P.
Daniel V.
Diaz J.V.
Figueiredo-Mello C.
Gelvez-Ramírez R.M.
Huyen T.B.
Kestelyn E.
Lam P.K.
Leopold S.J.
Li R.
Luu T.
Lye D.C.B.
McBride A.
Meyer-Andrieux I.
Moorman N.J.
Nguyen N.M.
Omar S.F.S.
Ong H.C.
Ooi E.E.
Pazukhina E.
Pett S.L.
Porto D.B.
Rajahram G.S.
Rogers M.
Rojas E.
Rosen J.
Rylance J.
Schilling W.H.K.
Siqueira A.M.
Sjö P.
Sucerquia-Hernandez A.
Tam D.T.H.
Teixeira M.M.
Tietz A.
Trieu H.T.
Unsworth A.
Villar L.
Waickman A.T.
Watson J.A.
Wills B.A.
Chia P.Y.
Brasil P.
Jaenisch T.
Lum L.
Malavige G.N.
McGloughlin S.
Tirupakuzhi Vijayaraghavan B.K.
Merson L.
Munblit D.
Ab Wahab S.
Adhikari N.K.
Ahmed M.J.
Arguni E.
Aryal D.
Bakri A.
SL Bastos L.
Bhusal S.
Blanco L.
Caoili J.
Celis-Salinas J.C.
Chaiwang S.
Chesnokov A.
Claure-Del Granado R.
Cruz Y.V.
Dahal A.
Dewi R.
Fareed K.
Felipe Reyes L.
Hashmi M.
Jayadas T.T.
Joshi M.
Karunananda M.V.
Katzelnick L.C.
Kevin M.
Lee S.W.
Leo Y.S.
M N.
Marshall J.
Mazlan M.Z.
Mustafa A.
Author's Affiliation
University of Oxford
University College London
National University of Singapore
The University of North Carolina at Chapel Hill
Monash University
King's College London
Medizinische Universität Wien
Universidade Federal de Minas Gerais
Universiti Malaya
Universitätsklinikum Heidelberg
Barts and The London School of Medicine and Dentistry
Organisation Mondiale de la Santé
Sechenov First Moscow State Medical University
The George Washington University School of Medicine and Health Sciences
NUS Yong Loo Lin School of Medicine
Novartis International AG
SUNY Upstate Medical University
University College London Hospitals NHS Foundation Trust
Nuffield Department of Medicine
Norton College of Medicine
Westmead Hospital
Duke-NUS Medical School
Siriraj Hospital
Tan Tock Seng Hospital
George Institute for Global Health
Lee Kong Chian School of Medicine
Colorado School of Public Health
UNC Eshelman School of Pharmacy
Kementerian Kesihatan Malaysia
University of Sri Jayewardenepura
Instituto Nacional de Infectologia Evandro Chagas (INI)
Mahidol Oxford Tropical Medicine Research Unit
MRC Centre for Inflammation Research
Oxford University Clinical Research Unit
Apollo Hospitals Group
Institut Pasteur de Dakar
European Medicines Agency
National Centre for Infectious Diseases
Instituto de Infectologia Emilio Ribas
Universidade Federal do Ceara, Faculdade de Medicina
Princess Marina Hospital
Infectious Diseases Data Observatory
Federal Institute for Drugs and Medical Devices
Drugs for Neglected Diseases initiative
Centro de Atención y Diagnóstico de Enfermedades Infecciosas
Novartis (China) Biomedical Research
Drugs for Neglected Diseases initiative
Drugs for Neglected Diseases Initiative
Rapidly Emerging Antiviral Drug Discovery Initiative
University College London
National University of Singapore
The University of North Carolina at Chapel Hill
Monash University
King's College London
Medizinische Universität Wien
Universidade Federal de Minas Gerais
Universiti Malaya
Universitätsklinikum Heidelberg
Barts and The London School of Medicine and Dentistry
Organisation Mondiale de la Santé
Sechenov First Moscow State Medical University
The George Washington University School of Medicine and Health Sciences
NUS Yong Loo Lin School of Medicine
Novartis International AG
SUNY Upstate Medical University
University College London Hospitals NHS Foundation Trust
Nuffield Department of Medicine
Norton College of Medicine
Westmead Hospital
Duke-NUS Medical School
Siriraj Hospital
Tan Tock Seng Hospital
George Institute for Global Health
Lee Kong Chian School of Medicine
Colorado School of Public Health
UNC Eshelman School of Pharmacy
Kementerian Kesihatan Malaysia
University of Sri Jayewardenepura
Instituto Nacional de Infectologia Evandro Chagas (INI)
Mahidol Oxford Tropical Medicine Research Unit
MRC Centre for Inflammation Research
Oxford University Clinical Research Unit
Apollo Hospitals Group
Institut Pasteur de Dakar
European Medicines Agency
National Centre for Infectious Diseases
Instituto de Infectologia Emilio Ribas
Universidade Federal do Ceara, Faculdade de Medicina
Princess Marina Hospital
Infectious Diseases Data Observatory
Federal Institute for Drugs and Medical Devices
Drugs for Neglected Diseases initiative
Centro de Atención y Diagnóstico de Enfermedades Infecciosas
Novartis (China) Biomedical Research
Drugs for Neglected Diseases initiative
Drugs for Neglected Diseases Initiative
Rapidly Emerging Antiviral Drug Discovery Initiative
Corresponding Author(s)
Other Contributor(s)
Abstract
Dengue, caused by any one of four distinct virus serotypes, is the most rapidly spreading mosquito-borne viral disease worldwide. It is a primary arboviral infection with increasing global incidence, driven by climate change, urbanisation, and the expanding range of Aedes mosquito vectors. Despite growing research interest, outcome and measurement instrument heterogeneity in dengue clinical trials remains high, limiting comparability and evidence synthesis. This project aimed to develop a globally relevant Core Outcome Measurement Set (COMS) for use in dengue clinical trials through international consensus. This consensus study followed core outcome measures in effectiveness trials and Core Outcome Set-Standards for Development (COS-STAD) guidelines and was conducted in two phases. Phase 1 focused on developing a Core Outcome Set (COS) through four steps: (1) a systematic literature review; (2) qualitative interviews with people with lived experience of dengue; (3) review by the management group and steering committee; (4) a two-round modified Delphi survey and structured online consensus meetings to finalise the COS for hospitalised and early stages of dengue disease. Input from critical care experts informed recommendations for the intensive care unit (ICU) and high dependency unit COS. Phase 2 consisted of a further two steps: (1) targeted review of outcome measurement instruments; and (2) a hybrid international consensus workshop to finalise the COMS. The agreed COMS for hospitalised dengue included seven outcomes; the early stage dengue COS included these outcomes plus four more. For critical care trials, use of existing ICU-specific COS was recommended. Unified definitions were developed for nine clinician-reported outcomes. The DEN-CORE COMS provides a consensus-based framework for harmonising outcome selection and measurement in dengue trials, improving comparability and supporting policy and clinical decision making.