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Completed

NCT Number: NCT01521416

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

The Cost of Illness Associated With Influenza in the UK

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2012
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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