Dengue illness index—A tool to characterize the subjective dengue illness experience
| Autor: | Thomas Jaenisch, Martin Erpicum, Liane Agulto, Bridget Wills, Lucy Chai See Lum, Piyarat Suntarattiwong, Duane J. Gubler, Walla Dempsey, Lian F. Thomas, João Bosco Siqueira, Kim Hendrickx, Alexander C. Schmidt, Stephen J. Thomas, Alexander Roberto Precioso, Kay M. Tomashek, Beth Ann Collers, Yee Sin Leo, Robert R. Edelman, Norma de Bosch, Federico Narvaez, Derek Wallace, Elsa Marina Rojas, M. Cristina Cassetti, Anna P. Durbin, Hasitha Tissera |
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| Přispěvatelé: | Hendrickx, Kim |
| Rok vydání: | 2018 |
| Předmět: |
Male
Viral Diseases Physiology Pathology and Laboratory Medicine Vascular Medicine Hepatitis law.invention Dengue fever Dengue 0302 clinical medicine Randomized controlled trial Animal Cells law Medicine and Health Sciences Clinical endpoint 030212 general & internal medicine Child Aged 80 and over Clinical Trials as Topic lcsh:Public aspects of medicine Hematology Middle Aged Body Fluids Myocarditis Treatment Outcome Blood Infectious Diseases Hematocrit Child Preschool Female Anatomy Cellular Types Research Article Adult Platelets medicine.medical_specialty lcsh:Arctic medicine. Tropical medicine Adolescent lcsh:RC955-962 Endpoint Determination 030231 tropical medicine Cardiology MEDLINE Dengue Vaccines Hemorrhage Context (language use) Antiviral Agents Blood Plasma Young Adult 03 medical and health sciences Signs and Symptoms Diagnostic Medicine medicine Humans Intensive care medicine Dengue vaccine Aged Blood Cells business.industry Public health Infant Newborn Hemodynamics Public Health Environmental and Occupational Health Infant Biology and Life Sciences lcsh:RA1-1270 Cell Biology medicine.disease Thrombocytopenia Blood Counts Clinical trial business |
| Zdroj: | PLoS Neglected Tropical Diseases PLoS Neglected Tropical Diseases, Vol 12, Iss 10, p e0006497 (2018) |
| ISSN: | 1935-2735 |
| DOI: | 10.1371/journal.pntd.0006497 |
| Popis: | Dengue is a major public health problem worldwide. Although several drug candidates have been evaluated in randomized controlled trials, none has been effective and at present, early recognition of severe dengue and timely supportive care are used to reduce mortality. While the first dengue vaccine was recently licensed, and several other candidates are in late stage clinical trials, future decisions regarding widespread deployment of vaccines and/or therapeutics will require evidence of product safety, efficacy and effectiveness. Standard, quantifiable clinical endpoints are needed to ensure reproducibility and comparability of research findings. To address this need, we established a working group of dengue researchers and public health specialists to develop standardized endpoints and work towards consensus opinion on those endpoints. After discussion at two working group meetings and presentations at international conferences, a Delphi methodology-based query was used to finalize and operationalize the clinical endpoints. Participants were asked to select the best endpoints from proposed definitions or offer revised/new definitions, and to indicate whether contributing items should be designated as optional or required. After the third round of inquiry, 70% or greater agreement was reached on moderate and severe plasma leakage, moderate and severe bleeding, acute hepatitis and acute liver failure, and moderate and severe neurologic disease. There was less agreement regarding moderate and severe thrombocytopenia and moderate and severe myocarditis. Notably, 68% of participants agreed that a 50,000 to 20,000 mm3 platelet range be used to define moderate thrombocytopenia; however, they remained divided on whether a rapid decreasing trend or one platelet count should be case defining. While at least 70% agreement was reached on most endpoints, the process identified areas for further evaluation and standardization within the context of ongoing clinical studies. These endpoints can be used to harmonize data collection and improve comparability between dengue clinical trials. Author summary Dengue is a major public health problem worldwide. Although several drug candidates have been evaluated in randomized controlled trials, none has been effective, and early recognition of severe dengue and timely supportive care remain the only means to reduce mortality. While the first dengue vaccine was recently licensed, and several other candidates are in late stage clinical trials, future decisions regarding deployment of such vaccines or therapeutics will require evidence of product safety, efficacy and effectiveness. Standard, quantifiable clinical endpoints are needed to ensure reproducibility and comparability of research findings. To address this need, we established a working group of dengue researchers, vaccine developers, and public health specialists to develop endpoints. After two working group meetings and discussions at international meetings, the Delphi methodology was used to clarify and further develop endpoints such that 70% or greater agreement was reached on most endpoint definitions including moderate and severe plasma leakage, moderate and severe bleeding, acute hepatitis and acute liver failure, and moderate and severe neurologic disease. The process identified areas for further evaluation and standardization within the context of ongoing clinical studies. The endpoints can be used to harmonize data collection and improve comparability between dengue clinical trials. |
| Databáze: | OpenAIRE |
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