Clinical trial NCT01339546: National Trends in Otitis Media in Children Under 5 Years of Age
Official title: National Trends In Ambulatory Care Visits For Otitis Media In Children Under The Age Of Five In The United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Myringotomy Tube Insertion
Skin Rash
Trauma
Keywords: ecologic
cross sectional
trend analysis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: National Ambulalatory Medical Care Survey (NAMCS)-national sample of visits to non federally employed office based physicians who are primarily engaged in direct patient care, and National Hospital Ambulatory Medical Care Survey (NHAMCS)- national sample of visits to emergency and outpatient departments and to ambulatory surgery facilities in noninstitutional general and short stay hospitals, exclusive of Federal, military, and Veterans Administration hospitals, located in the 50 States and the District of Columbia

Brief summary: The rationale for this study is to assess the change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5 years old in the United States.

Detailed description: NAMCS-The survey utilizes a three stage sampling design based on (1) probability of selecting a primary sampling unit (PSU) (2) probability of selecting a physician within the PSU and (3) probability of selecting a patient within the physician practice. This last probability is defined to be the exact number of office visits during physician's specified reporting week divided by the number of patient record forms completed. NHAMCS- For producing unbiased national estimate, this survey utilizes four stages (a) Probability of selecting a PSU (b) probability of selecting a hospital with in PSU (c) probability of selecting an emergency department (ED) or outpatient department (OPD) within the hospital (d) probability of selecting a visit within ED or OPD. The overall probability of selection is the product of the probabilities at each stage. The inverse of the overall selection probability is the basic inflation weight.

Eligibility criteria: Inclusion Criteria:

Five years of age or under at the time of visit, ambulatory visit for otitis media, myringotomy tube insertion, skin rash or trauma during study period

Exclusion Criteria:

Age over 5 years, no ambulatory visits for the events listed in inclusion criteria

Primary outcomes:
measure: Change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13vPnC vaccine (2011-2013) among children less than 5 years old
timeFrame: 1) 2001-2009 inclusive (9 years) and 2) 2011-2013 inclusive (3 years)
Secondary outcomes:
measure: Change in ambulatory care visit rates for acute otitis media between: 1) 1997-99 to 2001-09; and 2) between 1997-99 to 2011-13 among children less than 5 years old. (Timeframes are retrospective)
timeFrame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
measure: Change in ambulatory care visit rates for myringotomy tube insertion between: 1) 1997-99 to 2001-09; and 2) between 1997-99 to 2011-13 among children less than 5 years old. (Timeframes are retrospective
timeFrame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs)
measure: Change in ambulatory care visit rates for rash between 2001-09 to 2011 -13 among children less than 5 years old. (Timeframes are retrospective)
timeFrame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
measure: Change in ambulatory care visit rates for trauma between 2001-09 to 2011-13 among children less than 5 years old. (Timeframes are retrospective)
timeFrame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: