- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521416
Cost of Illness Associated With Influenza in the UK
The Cost of Illness Associated With Influenza in the UK
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.
- Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.
Exclusion Criteria:
Not Applicable
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort Group
|
Data of patients diagnosed with acute respiratory illness is extracted from General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Health Protection Agency (HPA), Office of National Statistics (ONS), and National Health Service (NHS) Reference Costs, during the period January 21st 2001 and March 31st 2009 inclusive. All analyses of primary care data (GPRD) and separately for secondary care (HES) data will be repeated for all eligible patients, and the subset of patients with a linkage to additional data (HES, ONS). All analysis including secondary care data will be restricted to the subset of patients with linked HES data. Estimates of average burden per patient and total burden in the UK will be performed. Burden is defined as both resource use and cost. Annual incidence and burden will be calculated. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of influenza-related events
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Number of confirmed influenza infections
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Assessment of resource use
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Evaluation of patient outcomes, treatments and costs (type and duration)
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Cause of deaths
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Incidence of influenza-related events in High Risk groups
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Incidence of complications and exacerbations
Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116313 (Investigation New Drug Application (IND))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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