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. 2015 Dec 16;49:90. doi: 10.1590/S0034-8910.2015049006058

Table 5. Summary of advantages and limitations of study design, data sources, and outcomes of interest used in HIA of vaccination programs.

  Advantages Limitations
Study design    

Ecological Relatively simple and less expensive Allows assessment of the vaccination program in a general population Cannot establish causal relationships It is important to consider adjustment for secular trends and to have a control group (other areas without vaccination programs or other diseases)
Cohort Provides the best information about causal relationships Demands more time and resources
Descriptive and case series Simplest study designs Can detect changes in types of rotavirus and pneumococcus after the introduction of vaccine programs Cannot measure prevalence or incidence due to the lack of a well-defined population at risk. Give little information about temporal changes in the frequency of diseases

Data sources    

Health information system databases Broad coverage, lower costs, easy access to data and longitudinal follow-up Lack of standardization in data collection and limitations in completeness and reliability of the available data, database continuity, coverage, representativeness, and sustainability
Sentinel-based and laboratory-based surveillance systems Availability of unpublished data Information on the catchment population frequently unavailable. Data not generalizable for the entire population. Variable coverage
Local secondary data (medical records of a single hospital) Timeliness, low costs, and availability Lack of standardization; data not generalizable to the entire population
Primary data May answer specific research objectives More precision and reliability Small sample size Not generalizable Expensive Sustainability

Clinical syndrome    

All-cause diarrhea Does not require specific laboratory tests. May be more valuable to decision makers Less precision for vaccine effect on rotavirus disease
Rotavirus-related diarrhea More specific and precise May underestimate the true burden of disease and the global impact of vaccination programs
Pneumonia More frequent Challenging and variable definition and diagnosis
Invasive pneumococcal disease More severe and of more precise diagnosis Diagnosis requires the isolation of S. pneumonia, and laboratory tests are not uniformly performed
Meningitis More severe, of more precise diagnosis and has more information available since it is a notifiable disease Less frequent

Outcomes of interest    

Hospitalization rate Availability of data Changes in diagnosis coding may affect estimates. Influenced by availability of beds, hospital admission policies and social factors. Unsuitable for clinical syndromes that are mostly treated in outpatient care such as otitis media
Mortality rate More reliable than morbidity data Measures only results of severe clinical syndromes; thus, changes in less severe conditions will not be identified. Difficulty in discriminating effects of changes in the incidence or treatment of conditions