Cost of Illness Associated With Influenza in the UK

August 29, 2013 updated by: GlaxoSmithKline

The Cost of Illness Associated With Influenza in the UK

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients coded within the relevant database (GPRD and HES) as having acute respiratory events that could be related to an infection between 2001 and 2009.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort Group
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

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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