Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible?
Abstract Lower respiratory tract illness or disease (LRTI/LRTD) represents a significant source of morbidity and mortality following viral respiratory illnesses, yet a consensus definition for this outcome is lacking. Recent studies of novel vaccines against respiratory syncytial virus (RSV) for old...
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| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2024-12-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-024-01087-x |
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| _version_ | 1832571428824678400 |
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| author | S. Elizabeth Williams Bradford Gessner Elizabeth Begier Negar Aliabadi Kumar Ilangovan Luis Jodar Cassandra Hall-Murray Giovanni Checcucci Lisi Edward Walsh |
| author_facet | S. Elizabeth Williams Bradford Gessner Elizabeth Begier Negar Aliabadi Kumar Ilangovan Luis Jodar Cassandra Hall-Murray Giovanni Checcucci Lisi Edward Walsh |
| author_sort | S. Elizabeth Williams |
| collection | DOAJ |
| description | Abstract Lower respiratory tract illness or disease (LRTI/LRTD) represents a significant source of morbidity and mortality following viral respiratory illnesses, yet a consensus definition for this outcome is lacking. Recent studies of novel vaccines against respiratory syncytial virus (RSV) for older adults used LRTI/LRTD as the primary outcome to assess vaccine efficacy. However, the different vaccine trials have used highly variable criteria to define this outcome, leading to difficulty in comparison of vaccine efficacy results between trials. Here we review the key differences in criteria for case definitions, highlight strategies to best approximate compatibility between definitions, and review vaccine efficacy results among currently US Food and Drug Administration (FDA)-approved vaccines using these strategies. We hope this overview will support the need to develop a consensus definition for LRTI/LRTD to improve future research related to viral respiratory disease. |
| format | Article |
| id | doaj-art-262dbc1188a64d44b288c44603008e8e |
| institution | Kabale University |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Infectious Diseases and Therapy |
| spelling | doaj-art-262dbc1188a64d44b288c44603008e8e2025-02-02T12:35:24ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822024-12-0114111110.1007/s40121-024-01087-xIs a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible?S. Elizabeth Williams0Bradford Gessner1Elizabeth Begier2Negar Aliabadi3Kumar Ilangovan4Luis Jodar5Cassandra Hall-Murray6Giovanni Checcucci Lisi7Edward Walsh8Vaccines Medical Development, Scientific and Clinical Affairs, Pfizer Inc.Vaccines Medical Development, Scientific and Clinical Affairs, Pfizer Inc.Pfizer VaccinesPfizer Inc.Pfizer Inc.Pfizer Inc.Vaccines Medical Development, Scientific and Clinical Affairs, Pfizer Inc.Pfizer Italia SrlUniversity of Rochester Medical CenterAbstract Lower respiratory tract illness or disease (LRTI/LRTD) represents a significant source of morbidity and mortality following viral respiratory illnesses, yet a consensus definition for this outcome is lacking. Recent studies of novel vaccines against respiratory syncytial virus (RSV) for older adults used LRTI/LRTD as the primary outcome to assess vaccine efficacy. However, the different vaccine trials have used highly variable criteria to define this outcome, leading to difficulty in comparison of vaccine efficacy results between trials. Here we review the key differences in criteria for case definitions, highlight strategies to best approximate compatibility between definitions, and review vaccine efficacy results among currently US Food and Drug Administration (FDA)-approved vaccines using these strategies. We hope this overview will support the need to develop a consensus definition for LRTI/LRTD to improve future research related to viral respiratory disease.https://doi.org/10.1007/s40121-024-01087-xVaccineLower respiratory tract illnessLower respiratory tract diseaseClinical case definitionRespiratory syncytial virusAdults |
| spellingShingle | S. Elizabeth Williams Bradford Gessner Elizabeth Begier Negar Aliabadi Kumar Ilangovan Luis Jodar Cassandra Hall-Murray Giovanni Checcucci Lisi Edward Walsh Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? Infectious Diseases and Therapy Vaccine Lower respiratory tract illness Lower respiratory tract disease Clinical case definition Respiratory syncytial virus Adults |
| title | Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? |
| title_full | Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? |
| title_fullStr | Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? |
| title_full_unstemmed | Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? |
| title_short | Is a Consensus Case Definition for Viral Associated Lower Respiratory Tract Disease (LRTD) in Clinical Trials Possible? |
| title_sort | is a consensus case definition for viral associated lower respiratory tract disease lrtd in clinical trials possible |
| topic | Vaccine Lower respiratory tract illness Lower respiratory tract disease Clinical case definition Respiratory syncytial virus Adults |
| url | https://doi.org/10.1007/s40121-024-01087-x |
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