Study to Assess the Burden of Mild Outcomes (Physician Office Visits) Due to Influenza in the United States

Burden of Mild Outcomes Due to Influenza in the United States, July 2000 Through April 2009 and October 2010 to May 2011

This is a database study to quantify the burden of multiple mild outcomes (i.e., those that result in visits to a physician's office) attributable to influenza in the United States, stratified by age group, geographic region and influenza subtype for selected influenza seasons.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Other: Data collection

Detailed Description

This is a retrospective database study to quantify the burden of multiple mild pre-defined influenza-attributable outcomes of interest, which resulted in physician office visits for persons who were less than 65 years of age, in the United States in the relevant Marketscan Commercial database in the period from July 2000 through April 2009, and October 2010 to May 2011. The corresponding physician office visits for persons 65 years of age and older, with a mild influenza-attributable outcome of interest, in the United States that were recorded in the relevant MarketScan Medicare Supplemental database in the period from July 2006 through April 2009, and October 2010 to May 2011 were also investigated. The period from April 2009 through September 2010 is excluded to avoid the H1N1 pandemic wave.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All records related to physician office visits of subjects less than 65 years of age and 65 years of age and older in the United States with an outcome of interest in the relevant Marketscan database.

Description

Inclusion Criteria:

• Recorded in a Marketscan database with any of the specified diagnostic codes.

Exclusion Criteria:

• Missing data in any of the following fields: age, diagnosis, region or visit date.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Applicable subjects less than 65 years of age identified in the Marketscan Commercial database during the period from July 2000 through April 2009, and October 2010 to May 2011 and subjects 65 years of age and older identified in MarketScan Medicare Supplemental database during the period from July 2006 through April 2009, and October 2010 to May 2011.	Other: Data collection; Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly occurrences of potentially influenza-attributable physician's office visits by age, region and season.	- All the events contained within "potentially influenza-attributable" office visits. - Weekly proportion of circulating influenza A and B strains determined for each season.	Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of Influenza vaccine content and effectiveness by season.	Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).
Assessment of Influenza vaccine coverage by season and region.	Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).
Assessment of Influenza B vaccine mismatch (by region and season).	Up to 10 years approximately (Marketscan Commercial Database) and up to 6 years approximately (Marketscan Medicare Supplemental Database).

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Matias G, Haguinet F, Lustig RL, Edelman L, Chowell G, Taylor RJ. Model estimates of the burden of outpatient visits attributable to influenza in the United States. BMC Infect Dis. 2016 Nov 7;16(1):641. doi: 10.1186/s12879-016-1939-7.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; Database; Retrospective; Mild outcomes; Influenza-attributable; United States of America (USA)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 117233