Cost of Illness Associated With Influenza in the UK

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01521416
First received: January 26, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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 Intervention
Influenza
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Cost of Illness Associated With Influenza in the UK

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of influenza-related events [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ] [ Designated as safety issue: No ]
  • Number of confirmed influenza infections [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ] [ Designated as safety issue: No ]
  • Assessment of resource use [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Cause of deaths [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Incidence of complications and exacerbations [ Time Frame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive) ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Group
Not Applicable
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.


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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:

Not Applicable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521416

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01521416     History of Changes
Other Study ID Numbers: 116313
Study First Received: January 26, 2012
Last Updated: August 29, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014