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Appropriateness of administrative data for vaccine impact evaluation: the case of pneumonia hospitalizations and pneumococcal vaccine in Brazil.

ABSTRACT: Ten-valent pneumococcal conjugate vaccine (PCV10) was recently introduced into the Brazilian Immunization Programme. Secondary data are used as a measurement of community-acquired pneumonia (CAP) burden, but their completeness and reliability need to be ascertained. We performed probabilistic linkage between hospital primary data from active prospective population-based surveillance (APS) and hospital secondary data from the Hospital Information System administrative database of the National Unified Health System (SIH-SUS). Children aged 2-23 months hospitalized during January-December 2012 were identified. Incidence rates of hospitalized CAP were estimated. Agreement of case identification was measured by kappa index. A total of 1639 (26%) CAP cases were identified in APS and 1714 (35%) in SIH-SUS. Of these 3353 records, 1127 CAP cases were present in both databases. Kappa on CAP case identification was 0·72 (95% confidence interval 0·69-0·75). CAP hospitalization incidence using administrative (5285/100 000) and hospital (5054/100 000) primary data were similar (P = 0·184). Our findings suggest that administrative databases of hospitalizations are reliable sources to assess PCV10 impact in time-series analyses.

SUBMITTER: Sgambatti S

PROVIDER: S-EPMC9206775 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Appropriateness of administrative data for vaccine impact evaluation: the case of pneumonia hospitalizations and pneumococcal vaccine in Brazil.

Sgambatti S S Minamisava R R Afonso E T ET Toscano C M CM Bierrenbach A L AL Andrade A L AL

Epidemiology and infection 20140423 2

Ten-valent pneumococcal conjugate vaccine (PCV10) was recently introduced into the Brazilian Immunization Programme. Secondary data are used as a measurement of community-acquired pneumonia (CAP) burden, but their completeness and reliability need to be ascertained. We performed probabilistic linkage between hospital primary data from active prospective population-based surveillance (APS) and hospital secondary data from the Hospital Information System administrative database of the National Uni ...[more]

PMID: 24759601

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Project description:BackgroundTen-valent pneumococcal conjugate vaccine (PCV10) was introduced in the National Immunization Program of Brazil in March/2010. Although there are recent reports of PCV10 impact on pneumonia hospitalizations, there is still uncertainty regarding the indirect impact in individuals non-targeted by vaccination. We assessed both direct and indirect effect of PCV10 on pneumonia hospitalizations and the impact on the economic burden of pneumonia hospitalizations.MethodsAn interrupted time-series analysis was conducted considering monthly rates of pneumonia hospitalizations and comparison groups, in all age-groups, from January/2005-December/2015. We used records of the National Hospitalizations Information System. Observed pneumonia rates in the post-vaccination period (2011–2015) were compared to predicted rates, should PCV10 had not been introduced. Relative percent difference in rates and its 95% confidence interval were estimated. The number of pneumonia hospitalizations averted by vaccination was calculated as the difference between the predicted and observed cumulative number of pneumonia hospitalizations in the post-vaccination period. The impact of PCV10 on economic burden was presented as averted costs of pneumonia hospitalization.ResultsSignificant decrease in rates of pneumonia hospitalization was observed in both children targeted by vaccination (17.4%–26.5%; p<0.01), and in age-groups not targeted by vaccination (11.1%–27.1%, in individuals 10–49 years; p<0.01). In contrast, PCV10 introduction did not alter the increasing trends in pneumonia hospitalization among elderly ≥65 years. A total of 457,564 pneumonia hospitalizations was averted in Brazil for individuals aged <50 years, with a total averted costs of BRL 383.2 million (Int$ 225.2 million, and USD 147 million) for the 5 year period after PCV introduction.ConclusionVaccination with PCV10 5 years after its introduction in Brazil was associated with a relevant reduction in pneumonia hospitalization in the target age-groups, with an indirect effect in individuals aged 10–49 years, and significant reduction in associated economic burden. The increasing trends in pneumonia hospitalization rates in the elderly is a matter of concern for public health and should be further investigated.

Project description:ImportanceCommunity-acquired pneumonia (CAP) remains one of the most common indications for pediatric hospitalization in the United States, and it is frequently the focus of research and quality studies. Use of administrative data is increasingly common for these purposes, although proper validation is required to ensure valid study conclusions.ObjectiveTo validate administrative billing data for hospitalizations owing to childhood CAP.Design and settingCase-control study of 4 tertiary care, freestanding children’s hospitals in the United States.ParticipantsA total of 998 medical records of a 25% random sample of 3646 children discharged in 2010 with at least 1 International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code representing possible pneumonia were reviewed. Discharges (matched on date of admission) without a pneumonia-related discharge code were also examined to identify potential missed pneumonia cases. Two reference standards, based on provider diagnosis alone (provider confirmed) or in combination with consistent clinical and radiographic evidence of pneumonia (definite), were used to identify CAP.ExposureTwelve ICD-9-CM–based coding strategies, each using a combination of primary or secondary codes representing pneumonia or pneumonia-related complications. Six algorithms excluded children with complex chronic conditions.Main outcomes and measuresSensitivity, specificity, and negative and positive predictive values (NPV and PPV, respectively) of the 12 identification strategies.ResultsFor provider-confirmed CAP (n = 680), sensitivity ranged from 60.7% to 99.7%; specificity, 75.7% to 96.4%; PPV, 67.9% to 89.6%; and NPV, 82.6% to 99.8%. For definite CAP (n = 547), sensitivity ranged from 65.6% to 99.6%; specificity, 68.7% to 93.0%; PPV, 54.6% to 77.9%; and NPV, 87.8% to 99.8%. Unrestricted use of the pneumonia-related codes was inaccurate, although several strategies improved specificity to more than 90% with a variable effect on sensitivity. Excluding children with complex chronic conditions demonstrated the most favorable performance characteristics. Performance of the algorithms was similar across institutions.Conclusions and relevanceAdministrative data are valuable for studying pediatric CAP hospitalizations. The strategies presented here will aid in the accurate identification of relevant and comparable patient populations for research and performance improvement studies.

Project description:BACKGROUND:Understanding the real-world effect of pneumococcal conjugate vaccines (PCVs) on pneumonia mortality is crucial because of the expectation that increased PCV use will substantially reduce the burden of pneumonia deaths in children younger than 5 years. However, few post-vaccine introduction studies have estimated the benefits of PCV use on childhood mortality and results have been inconsistent. Therefore, we set out to assess the effect of introduction of ten-valent pneumococcal conjugate vaccine (PCV10) on pneumonia mortality in children in Brazil. METHODS:In this retrospective observational study, we used publicly available mortality data of children aged 3-59 months in Brazil. We separated data by age group (3-11 months, 3-23 months, and 3-59 months) and stratified data by three different socioeconomic factors of Brazilian municipalities (in 2010): Human Development Index, proportion of children living in extreme poverty, and proportion of mothers with no primary education. We first examined long-term trends in childhood pneumonia mortality in Brazil (from 1980 to 2014). We then assessed the effect of PCV10-introduced in Brazil in 2010-both nationally and in municipalities stratified by socioeconomic status, with a synthetic control approach as our primary analytical method. FINDINGS:Between 1980 and 2010, a period during which Brazil's Human Development Index rose substantially, national pneumonia mortality in children younger than 5 years decreased from about 150 to 15 deaths per 100 000 children younger than 5 years. Despite rapid uptake of PCV10 after its introduction in 2010, we observed a further vaccine-associated decline of about 10% in national childhood pneumonia mortality with our primary analytical method, with a high degree of uncertainty in the estimates. We observed larger reductions in municipal childhood pneumonia mortality in all three age groups (3-11 months, 3-23 months, and 3-59 months) in municipalities with a high percentage of extreme childhood poverty and mothers with no primary education, with the largest decrease observed in children aged 3-23 months in municipalities with low maternal education (24%, 95% credible interval 7-35). INTERPRETATION:The large reduction observed from 1980 to 2010 in national pneumonia mortality in children younger than 5 years underscores that improvements in nutrition, hygiene, education, and health care have an important role in reducing pneumonia mortality. Although the PCV-associated reduction in childhood pneumonia mortality at the national level was modest, we found that PCV led to larger reductions in low-income municipalities. Similarly, large benefits might occur when PCVs are introduced in other low-income settings. FUNDING:Bill & Melinda Gates Foundation and National Institute of Allergy and Infectious Diseases.

Project description:BackgroundIn March 2010, Brazil introduced the ten-valent pneumococcal conjugate vaccine (PCV10), which was licensed based on non-inferiority of immunological correlates of protection compared with the seven-valent vaccine. The schedule comprised three primary doses at ages 2 months, 4 months, and 6 months, and a booster dose at age 12 months. A single catch-up dose was offered for children aged 12-23 months at the time of introduction. We assessed PCV10 effectiveness against invasive pneumococcal disease in Brazilian children.MethodsInvasive pneumococcal disease, defined as isolation of Streptococcus pneumoniae from blood, cerebrospinal fluid, or another normally sterile site, was identified in children age-eligible for at least one PCV10 dose through laboratory-based and hospital-based surveillance in ten states in Brazil from March 1, 2010, until Dec 31, 2012. We aimed to identify four age-matched and neighbourhood-matched controls for each case. We used conditional logistic regression and calculated PCV10 effectiveness as (1-adjusted matched odds ratio) × 100% for vaccine-type and vaccine-related serotypes (ie, in the same serogroup as a vaccine serotype).FindingsIn 316 cases (median age 13·2 months, range 2·6-53·1) and 1219 controls (13·3 months, 2·6-53·1), the adjusted effectiveness of an age-appropriate PCV10 schedule was 83·8% (95% CI 65·9-92·3) against vaccine serotypes, and 77·9% (41·0-91·7) against vaccine-related serotypes. Serotype-specific effectiveness was shown for the two most common vaccine serotypes-14 (87·7%, 60·8-96·1) and 6B (82·8%, 23·8-96·1)-and serotype 19A (82·2%, 10·7-96·4), a serotype related to vaccine serotype 19F. A single catch-up dose in children aged 12-23 months was effective against vaccine-type disease (68·0%, 17·6-87·6). No significant effectiveness was shown against non-vaccine serotypes for age-appropriate or catch-up schedules.InterpretationIn the routine immunisation programme in Brazil, PCV10 prevents invasive disease caused by vaccine serotypes. PCV10 might provide cross-protection against some vaccine-related serotypes.FundingBrazilian Ministry of Health, Pan-American Health Organization, and US Centers for Disease Control and Prevention.

Project description:BackgroundVaccination with the 23-valent pneumococcal polysaccharide vaccine (PPV23) is available in the United Kingdom to adults aged 65 years or older and those in defined clinical risk groups. We evaluated the vaccine effectiveness (VE) of PPV23 against vaccine-type pneumococcal pneumonia in a cohort of adults hospitalised with community-acquired pneumonia (CAP).Methods and findingsUsing a case-control test-negative design, a secondary analysis of data was conducted from a prospective cohort study of adults (aged ≥16 years) with CAP hospitalised at 2 university teaching hospitals in Nottingham, England, from September 2013 to August 2018. The exposure of interest was PPV23 vaccination at any time point prior to the index admission. A case was defined as PPV23 serotype-specific pneumococcal pneumonia and a control as non-PPV23 serotype pneumococcal pneumonia or nonpneumococcal pneumonia. Pneumococcal serotypes were identified from urine samples using a multiplex immunoassay or from positive blood cultures. Multivariable logistic regression was used to derive adjusted odds of case status between vaccinated and unvaccinated individuals; VE estimates were calculated as (1 - odds ratio) × 100%. Of 2,357 patients, there were 717 PPV23 cases (48% vaccinated) and 1,640 controls (54.5% vaccinated). The adjusted VE (aVE) estimate against PPV23 serotype disease was 24% (95% CI 5%-40%, p = 0.02). Estimates were similar in analyses restricted to vaccine-eligible patients (n = 1,768, aVE 23%, 95% CI 1%-40%) and patients aged ≥65 years (n = 1,407, aVE 20%, 95% CI -5% to 40%), but not in patients aged ≥75 years (n = 905, aVE 5%, 95% CI -37% to 35%). The aVE estimate in relation to PPV23/non-13-valent pneumococcal conjugate vaccine (PCV13) serotype pneumonia (n = 417 cases, 43.7% vaccinated) was 29% (95% CI 6%-46%). Key limitations of this study are that, due to high vaccination rates, there was a lack of power to reject the null hypothesis of no vaccine effect, and that the study was not large enough to allow robust subgroup analysis in the older age groups.ConclusionsIn the setting of an established national childhood PCV13 vaccination programme, PPV23 vaccination of clinical at-risk patient groups and adults aged ≥65 years provided moderate long-term protection against hospitalisation with PPV23 serotype pneumonia. These findings suggest that PPV23 vaccination may continue to have an important role in adult pneumococcal vaccine policy, including the possibility of revaccination of older adults.

Dataset Information

Appropriateness of administrative data for vaccine impact evaluation: the case of pneumonia hospitalizations and pneumococcal vaccine in Brazil.

Publications

Appropriateness of administrative data for vaccine impact evaluation: the case of pneumonia hospitalizations and pneumococcal vaccine in Brazil.

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