Cost of Illness Associated With Influenza in the UK

Influenza Clinical Trial

Official title:

The Cost of Illness Associated With Influenza in the UK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521416
• Other study ID #: 116313
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: August 29, 2013
• Start date: June 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

The objective of this study is to describe the burden associated with influenza in the UK, from both primary and secondary care perspectives, and to stratify the burden by the annual degree of mismatch between predicted and actual virus strains.

Description:

This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 65 Years

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Other:
• Data collection
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of influenza-related events		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Number of confirmed influenza infections		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Assessment of resource use		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Evaluation of patient outcomes, treatments and costs (type and duration)		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Cause of deaths		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Incidence of influenza-related events in High Risk groups		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No
Primary	Incidence of complications and exacerbations		Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)	No