National Trends in Otitis Media in Children Under 5 Years of Age
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Otitis Media Myringotomy Tube Insertion Skin Rash Trauma |
Other: no intervention |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Retrospective |
| Official Title: | Assessment of National Trends in Otitis Media in Children Under 5 Years of Age Following the Introduction of 13vPnC Vaccine in the USA. |
- 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 [ Time Frame: 1) 2001-2009 inclusive (9 years) and 2) 2011-2013 inclusive (3 years) ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs) ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 1) 1997-99 inclusive (3 yrs); 2) 2001-09 inclusive (9 yrs) and 3) 2011-13 inclusive (3 yrs) ] [ Designated as safety issue: No ]
- Change in ambulatory care visit rates for rash between 2001-09 to 2011 -13 among children less than 5 years old. (Timeframes are retrospective) [ Time Frame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs) ] [ Designated as safety issue: No ]
- Change in ambulatory care visit rates for trauma between 2001-09 to 2011-13 among children less than 5 years old. (Timeframes are retrospective) [ Time Frame: 1) 2001-09 inclusive (9 yrs) and 2) 2011-13 inclusive (3 yrs) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study population
All ambulatory visits for otitis media, myringotomy tube insertion, skin rash or trauma among children age 5 or under during the periods of study
|
Other: no intervention
not applicable
|
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| Ages Eligible for Study: | 2 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01339546 History of Changes |
| Other Study ID Numbers: | 6096A1-4018, B1851041 |
| Study First Received: | December 22, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pfizer:
|
ecologic cross sectional trend analysis |
Additional relevant MeSH terms:
|
Exanthema Otitis Otitis Media |
Skin Diseases Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013