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

NCT ID: NCT02019732

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

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.

Conditions

Influenza

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Data collection

Intervention Type: OTHER

Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).

Interventions

Data collection

Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27821091 (View on PubMed)

Other Identifiers

117233

Identifier Type: -

Identifier Source: org_study_id