Development of an Ordinal Scale Treatment Endpoint for Adults Hospitalized With Influenza
| Autor: | David S.C. Hui, Rity Y. K. Wong, Steven J. Drews, Nelson Lee, Stephanie Smith, Paul K.S. Chan, Mary Labib, Lori Zapernick, Sandy Shokoples, Nathan Zelyas, Dean T. Eurich, Ming Ye |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Microbiology (medical) medicine.medical_specialty business.industry Ordinal Scale Odds ratio Antiviral Agents Intensive care unit Confidence interval law.invention Hospitalization Treatment Outcome Infectious Diseases Respiratory failure law Internal medicine Acute care Influenza Human medicine Clinical endpoint Humans Ordered logit Enzyme Inhibitors business Aged |
| Zdroj: | Clinical Infectious Diseases. 73:e4369-e4374 |
| ISSN: | 1537-6591 1058-4838 |
| DOI: | 10.1093/cid/ciaa777 |
| Popis: | Background An obstacle in influenza therapeutics development is the lack of clinical endpoints, especially in hospitalized patients. A single time-point binary outcome measure is limited by patients’ diverse clinical trajectories and low event rates. Methods A 6-point ordinal scale with ascending clinical status severity (scoring: discharged; subacute care; acute care without/with respiratory failure; intensive care unit [ICU]; death) was proposed to study outcomes of adults hospitalized with influenza. Individual patient data from 2 active surveillance cohorts’ datasets (2015/2016−2017/2018; Edmonton, Hong Kong) was used for evaluation. The impact of neuraminidase inhibitor (NAI) treatment on longitudinal ordinal outcome changes over 30 days was analyzed using mixed-effects ordinal logistic regression and group-based trajectory models. Results Patient (n = 1226) baseline characteristics included age (mean 68.0 years), virus-type (A 78.1%, B 21.9%), respiratory failure (57.2%), ICU admittance (14.4%), and NAI treatment within 5 days of illness (69.2%). Outcomes at 30 days included discharged (75.2%), subacute care (13.7%), acute care (4.5%), and death (6.6%). Two main clinical trajectories were identified, predictive by baseline scoring (mean ± SD, 4.3 ± 0.6 vs 3.5 ± 0.6, P Conclusions The ordinal outcome scale is a potentially useful clinical endpoint for influenza therapeutic trials, which could account for the diverse clinical trajectories of hospitalized patients, warranting further development. |
| Databáze: | OpenAIRE |
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