Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants

GlaxoSmithKline1 enrolled

Overview

This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.

This study will utilize the OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of DTaP vaccinations received prior to infection.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diphtheria Acellular Pertussis Tetanus

Interventions

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

Inclusion Criteria: * Date of birth between July 1, 2005 and September 30, 2010. * Enrollment in a commercial health plan within one month of birth. * Known sex and geographic region. * Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control. Exclusion Criteria: • Enrollment does not include medical and pharmacy coverage.

Outcomes

Primary Outcomes

Assessment of claim identified pertussis/whooping cough

The endpoint(s) for the primary objective are the odds ratios associated with factors modelled in a logistic regression (conditional logit model) where the outcome is the diagnosis of pertussis/whooping cough. Demographic, economic and clinical risk factors available in the administrative claims database and potentially associated with pertussis/whooping cough infection will be estimated. Covariates will be determined based on clinical rationale and statistical significance.

Time frame: Up to one year

Assessment of health care resource utilization

Health care resource utilization (e.g. ambulatory visits, emergency department visits, inpatient hospitalizations, length of stay) will be calculated for infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection.

Time frame: Up to one year

Assessment of health care costs

Health care costs will be computed as the combined health plan and patient paid amounts in the post-index period. Costs will be calculated as a total costs, medical costs, pharmacy costs, ambulatory costs, emergency costs and other costs and split by those occurring prior to the index date and those in the follow-up period. Costs will be adjusted to 2012 U.S. dollar values using the Medical Care Consumer Price Index.

Time frame: Up to one year