An assessment of the screening method to evaluate vaccine effectiveness: the case of 7-valent pneumococcal conjugate vaccine in the United States.

The screening method, which employs readily available data, is an inexpensive and quick means of estimating vaccine effectiveness (VE). We compared estimates of effectiveness of heptavalent pneumococcal conjugate vaccine (PCV7) against invasive pneumococcal disease (IPD) using the screening and case-control methods. Cases were children aged 19-35 months with pneumococcus isolated from normally sterile sites residing in Active Bacterial Core surveillance areas in the United States. Case-control VE was estimated for 2001-2004 by comparing the odds of vaccination among cases and community controls. Screening-method VE for 2001-2009 was estimated by comparing the proportion of cases vaccinated to National Immunization Survey-derived coverage among the general population. To evaluate the plausibility of screening-method VE findings, we estimated attack rates among vaccinated and unvaccinated persons. We identified 1,154 children with IPD. Annual population PCV7 coverage with ≥1 dose increased from 38% to 97%. Case-control VE for ≥1 dose was estimated as 75% against all-serotype IPD (annual range: 35-83%) and 91% for PCV7-type IPD (annual range: 65-100%). By the screening method, the overall VE was 86% for ≥1 dose (annual range: -240-70%) against all-serotype IPD and 94% (annual range: 62-97%) against PCV7-type IPD. As cases of PCV7-type IPD declined during 2001-2005, estimated attack rates for all-serotype IPD among vaccinated and unvaccinated individuals became less consistent than what would be expected with the estimated effectiveness of PCV7. The screening method yields estimates of VE that are highly dependent on the time period during which it is used and the choice of outcome. The method should be used cautiously to evaluate VE of PCVs

Evaluation of Surveillance Methods for Staphylococcal Toxic Shock Syndrome

We compared passive surveillance and International Classification of Diseases, 9th Revision, codes for completeness of staphylococcal toxic shock syndrome (TSS) surveillance in the Minneapolis–St. Paul area, Minnesota, USA. TSS-specific codes identified 55% of cases compared with 30% by passive surveillance and were more sensitive (p = 0.0005, McNemar χ2 12.25)

Staphylococcal Toxic Shock Syndrome 2000–2006: Epidemiology, Clinical Features, and Molecular Characteristics

Circulating strains of Staphylococcus aureus (SA) have changed in the last 30 years including the emergence of community-associated methicillin-resistant SA (MRSA). A report suggested staphylococcal toxic shock syndrome (TSS) was increasing over 2000-2003. The last population-based assessment of TSS was 1986.Population-based active surveillance for TSS meeting the CDC definition using ICD-9 codes was conducted in the Minneapolis-St. Paul area (population 2,642,056) from 2000-2006. Medical records of potential cases were reviewed for case criteria, antimicrobial susceptibility, risk factors, and outcome. Superantigen PCR testing and PFGE were performed on available isolates from probable and confirmed cases.Of 7,491 hospitalizations that received one of the ICD-9 study codes, 61 TSS cases (33 menstrual, 28 non-menstrual) were identified. The average annual incidence per 100,000 of all, menstrual, and non-menstrual TSS was 0.52 (95% CI, 0.32-0.77), 0.69 (0.39-1.16), and 0.32 (0.12-0.67), respectively. Women 13-24 years had the highest incidence at 1.41 (0.63-2.61). No increase in incidence was observed from 2000-2006. MRSA was isolated in 1 menstrual and 3 non-menstrual cases (7% of TSS cases); 1 isolate was USA400. The superantigen gene tst-1 was identified in 20 (80%) of isolates and was more common in menstrual compared to non-menstrual isolates (89% vs. 50%, p = 0.07). Superantigen genes sea, seb and sec were found more frequently among non-menstrual compared to menstrual isolates [100% vs 25% (p = 0.4), 60% vs 0% (p<0.01), and 25% vs 13% (p = 0.5), respectively].TSS incidence remained stable across our surveillance period of 2000-2006 and compared to past population-based estimates in the 1980s. MRSA accounted for a small percentage of TSS cases. tst-1 continues to be the superantigen associated with the majority of menstrual cases. The CDC case definition identifies the most severe cases and has been consistently used but likely results in a substantial underestimation of the total TSS disease burden

Surveillance Case Definition of TSS [28].

<p>Surveillance Case Definition of TSS <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0022997#pone.0022997-Centers1" target="_blank">[28]</a>.</p

Flow diagram of TSS case ascertainment.

<p>From 2000–2003 TSS cases were identified from multiple data sources including ICD-9 hospital discharge codes, cases reported to the Minnesota Unexplained Critical Illness and Death of Possible Infectious Etiology project (UNEX), and death certificate data using ICD-10 code A48.3. From 2004–2006 TSS cases were identified from only the TSS-specific ICD-9 hospital discharge code.</p

ICD-9 Study Codes Utilized for TSS Case Ascertainment.

<p>*The ICD-9 code number assigned to “toxic shock syndrome” changed from 040.89 to 040.82 on October 1, 2002, and the code number assigned to “sepsis” changed from 785.59 to 785.52 on October 1, 2003. While the numeric codes changed, their associated diagnoses remained unchanged and are considered mutually exclusive.</p>†<p>Code eliminated after interim analysis.</p

Average Annual Toxic Shock Syndrome Incidence by Age and Gender Groups During the Period of Most Complete Case Ascertainment, 2000–2003.

<p>Abbreviations: CI, Bayesian confidence interval, TSS, toxic shock syndrome; yr, year.</p><p>*Annual incidence averaged over all study years, 2000–2003 and estimated by Bayesian statistical methods and Poisson regression.</p