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Cost of Illness Associated With Influenza in the UK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521416
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : September 2, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Influenza Other: Data collection

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 Design

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Cost of Illness Associated With Influenza in the UK
Study Start Date : June 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts

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.



Outcome Measures

Primary Outcome Measures :
  1. Incidence of influenza-related events [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ]
  2. Number of confirmed influenza infections [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ]
  3. Assessment of resource use [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ]
  4. 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) ]
  5. Cause of deaths [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ]
  6. 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) ]
  7. Incidence of complications and exacerbations [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521416


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01521416     History of Changes
Other Study ID Numbers: 116313
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

Keywords provided by GlaxoSmithKline:
Illness
Influenza
Cost
UK

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases