Exploration of the Hospital Recovery Scale as an endpoint to assess clinical improvement in hospitalized influenza patients

Exploration of the Hospital Recovery Scale as an endpoint to assess clinical improvement in hospitalized influenza patients

The best way to evaluate the effectiveness of a new therapy for hospitalized patients with influenza is not known. The researchers are exploring a new measure, called the Hospital Recovery Scale (HRS), that might be used in clinical research to show the effectiveness of a new influenza treatment in patients who are hospitalized for influenza. The HRS captures the clinical status at a specific timepoint and consists of six categories that assess the patient status from best to worse: (1) Not Hospitalized [Home](2) Non-Intensive Care (ICU) Hospitalization, Not Requiring Supplemental Oxygen [Ward](3) Non-ICU Hospitalization, Requiring Supplemental Oxygen [Oxygen](4) Admitted to the ICU, Not Requiring Invasive Mechanical Ventilation [ICU] (5) Requiring Invasive Mechanical Ventilation [Vent.](6) Death [Death]The HRS describes the hospitalization status of an influenza patient each day. Measured daily, the HRS provides insight in the progression of an influenza patient's hospitalization status over time. The patient's status can be analyzed and compared between (sub)groups of patients. Similarly designed ordinal scale endpoints have been recently used in other research in severe influenza patients requiring hospitalization. The ZORO study (GSK-NAI114373; NCT01231620) has been selected because it is a large study that includes adolescent and adult patients hospitalized with influenza with the expectation that it contains the data to be able to characterize patients appropriately on the HRS and other endpoints. All patients who are infected with influenza and were treated will be included in this exploration, with primary interest in patients infected with Influenza A. The objectives of this research are:
• To explore the HRS as a new endpoint to assess clinical improvement in hospitalized influenza patients
• To explore the correspondence of the HRS outcome with other clinical endpoints in a hospitalized influenza patient setting
• To explore the correspondence of the effect of the HRS outcome with other established clinical outcomes in a hospitalized influenza patient setting between (sub)groups The other clinical outcomes which will be explored include:
• what proportion of patients experience complications of influenza
• how long patients need to stay in the hospital
• what proportion of patients need intensive care
• what proportion of patients need to use a breathing machine (mechanical ventilation)
• what proportion of patients die
• how long it takes before patients return to pre-influenza activity and function
• how long it takes to recover from influenza symptoms
• how long it takes for breathing to improve to usual levels
• how long patients need extra supplemental oxygen.
The results of this analysis will be made public and will be submitted for presentation at a scientific conference and will also be submitted for potential publication in scientific journals.

[{ "PostingID": 4740, "Title": "GSK-NAI114373", "Description": "A Phase III international, randomized, double-blind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza" }]