Effectiveness of Vaccines and Monoclonal Antibodies Against Respiratory Syncytial Virus: Generic Protocol for Register-Based Cohort Study.

Several immunization products are currently being developed against respiratory syncytial virus (RSV) for children, pregnant females, and older adults, and some products have already received authorization. Therefore, studies to monitor the effectiveness of these products are needed in the following years. To assist researchers to conduct postmarketing studies, we developed a generic protocol for register-based cohort studies to evaluate immunization product effectiveness against RSV-specific and nonspecific outcomes. To conduct a study on the basis of this generic protocol, the researchers can use any relevant databases or healthcare registers that are available at the study site.

Effectiveness of Immunization Products Against Medically Attended Respiratory Syncytial Virus Infection: Generic Protocol for a Test-Negative Case-Control Study.

Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) products is of major public health importance. This generic protocol for a test-negative design study aims to address currently envisioned approaches for RSV prevention (monoclonal antibodies and vaccines) to study effectiveness of these products among target groups: children, older adults, and pregnant women. The generic protocol approach was chosen to allow for flexibility in adapting the protocol to a specific setting. This protocol includes severe acute respiratory infection (SARI) and acute respiratory infection (ARI), both due to RSV, as end points. These end points can be applied to studies in hospitals, primarily targeting patients with more severe disease, but also to studies in general practitioner clinics targeting ARI.

Multicountry Review of Streptococcus pneumoniae Serotype Distribution Among Adults With Community-Acquired Pneumonia.

BACKGROUND: Nonbacteremic community-acquired pneumonia (CAP) is a leading presentation of severe pneumococcal disease in adults. Serotype-specific urinary antigen detection (UAD) assay can detect serotypes causing pneumococcal CAP, including nonbacteremic cases, and guide recommendations for use of higher valency pneumococcal conjugate vaccines (PCVs). METHODS: Adult CAP serotype distribution studies that used both Pfizer UADs (UAD1, detects PCV13 serotypes; UAD2, detects PCV20 non-PCV13 serotypes plus 2, 9N, 17F, and 20) were identified by review of an internal study database and included if results were published. The percentages of all-cause radiologically confirmed CAP (RAD + CAP) due to individual or grouped (PCV13, PCV15, and PCV20) serotypes as detected from culture or UAD were reported. RESULTS: Six studies (n = 2, United States; n = 1 each, Germany, Sweden, Spain, and Greece) were included. The percentage of RAD + CAP among adults ≥18 years with PCV13 serotypes equaled 4.6% to 12.9%, with PCV15 serotypes 5.9% to 14.5%, and with PCV20 serotypes 7.8% to 23.8%. The percentage of RAD + CAP due to PCV15 and PCV20 serotypes was 1.1-1.3 and 1.3-1.8 times higher than PCV13 serotypes, respectively. CONCLUSIONS: PCV13 serotypes remain a cause of RAD + CAP among adults even in settings with pediatric PCV use. Higher valency PCVs among adults could address an important proportion of RAD + CAP in this population.

Influenza Vaccine Effectiveness Pre-pandemic Among Adults Hospitalized With Congestive Heart Failure or Chronic Obstructive Pulmonary Disease and Older Adults.

BACKGROUND: Data are limited on influenza vaccine effectiveness (VE) in the prevention of influenza-related hospitalizations in older adults and those with underlying high-risk comorbidities. METHODS: We conducted a prospective, test-negative, case-control study at 2 US hospitals from October 2018-March 2020 among adults aged ≥50 years hospitalized with acute respiratory illnesses (ARIs) and adults ≥18 years admitted with congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) exacerbations. Adults were eligible if they resided in 1 of 8 counties in metropolitan Atlanta, Georgia. Nasopharyngeal and oropharyngeal swabs were tested using BioFire FilmArray (bioMérieux, Inc.) respiratory panel, and standard-of-care molecular results were included when available. Influenza vaccination history was determined from the Georgia vaccine registry and medical records. We used multivariable logistic regression to control for potential confounders and to determine 95% confidence intervals (CIs). RESULTS: Among 3090 eligible adults, 1562 (50.6%) were enrolled. Of the 1515 with influenza vaccination history available, 701 (46.2%) had received vaccination during that season. Influenza was identified in 37 (5.3%) vaccinated versus 78 (9.6%) unvaccinated participants. After adjustment for age, race/ethnicity, immunosuppression, month, and season, pooled VE for any influenza-related hospitalization in the eligible study population was 63.1% (95% CI, 43.8-75.8%). Adjusted VE against influenza-related hospitalization for ARI in adults ≥50 years was 55.9% (29.9-72.3%) and adjusted VE against influenza-related CHF/COPD exacerbation in adults ≥18 years was 80.3% (36.3-93.9%). CONCLUSIONS: Influenza vaccination was effective in preventing influenza-related hospitalizations in adults aged ≥50 years and those with CHF/COPD exacerbations during the 2018-2020 seasons.

Pediatric Respiratory Syncytial Virus Diagnostic Testing Performance: A Systematic Review and Meta-analysis.

BACKGROUND: Adding additional specimen types (eg, serology or sputum) to nasopharyngeal swab (NPS) reverse transcription polymerase chain reaction (RT-PCR) increases respiratory syncytial virus (RSV) detection among adults. We assessed if a similar increase occurs in children and quantified underascertainment associated with diagnostic testing. METHODS: We searched databases for studies involving RSV detection in persons <18 years using ≥2 specimen types or tests. We assessed study quality using a validated checklist. We pooled detection rates by specimen and diagnostic tests and quantified performance. RESULTS: We included 157 studies. Added testing of additional specimens to NP aspirate (NPA), NPS, and/or nasal swab (NS) RT-PCR resulted in statistically nonsignificant increases in RSV detection. Adding paired serology testing increased RSV detection by 10%, NS by 8%, oropharyngeal swabs by 5%, and NPS by 1%. Compared to RT-PCR, direct fluorescence antibody tests, viral culture, and rapid antigen tests were 87%, 76%, and 74% sensitive, respectively (pooled specificities all ≥98%). Pooled sensitivity of multiplex versus singleplex RT-PCR was 96%. CONCLUSIONS: RT-PCR was the most sensitive pediatric RSV diagnostic test. Adding multiple specimens did not substantially increase RSV detection, but even small proportional increases could result in meaningful changes in burden estimates. The synergistic effect of adding multiple specimens should be evaluated.

Underascertainment of Respiratory Syncytial Virus Infection in Adults Due to Diagnostic Testing Limitations: A Systematic Literature Review and Meta-analysis.

BACKGROUND: Most observational population-based studies identify respiratory syncytial virus (RSV) by nasal/nasopharyngeal swab reverse transcriptase real-time PCR (RT-PCR) only. We conducted a systematic review and meta-analyses to quantify specimen and diagnostic testing-based underascertainment of adult RSV infection. METHODS: EMBASE, PubMed, and Web of Science were searched (January 2000-December 2021) for studies including adults using/comparing >1 RSV testing approach. We quantified test performance and RSV detection increase associated with using multiple specimen types. RESULTS: Among 8066 references identified, 154 met inclusion. Compared to RT-PCR, other methods were less sensitive: rapid antigen detection test (RADT; pooled sensitivity, 64%), direct fluorescent antibody (DFA; 83%), and viral culture (86%). Compared to singleplex PCR, multiplex PCR's sensitivity was lower (93%). Compared to nasal/nasopharyngeal swab RT-PCR alone, adding another specimen type increased detection: sputum RT-PCR, 52%; 4-fold rise in paired serology, 44%; and oropharyngeal swab RT-PCR, 28%. Sensitivity was lower in estimates limited to only adults (for RADT, DFA, and viral culture), and detection rate increases were largely comparable. CONCLUSIONS: RT-PCR, particularly singleplex testing, is the most sensitive RSV diagnostic test in adults. Adding additional specimen types to nasopharyngeal swab RT-PCR testing increased RSV detection. Synergistic effects of using ≥3 specimen types should be assessed, as this approach may improve the accuracy of adult RSV burden estimates.

Respiratory syncytial virus (RSV) is an important cause of illness and death among older adults. Most studies of how frequent RSV infection is among older adults use only nasal swab testing to identify RSV infection. These nasal swabs are checked for genetic material from the virus, known as polymerase chain reaction (PCR) testing. We examined published studies from January 2000 to December 2021 to estimate how many RSV infections would be missed by using only this approach to RSV testing. We found 154 studies had information to answer our question. Compared to PCR testing of nasal swab alone, adding sputum specimen PCR testing (ie, testing cough mucus or phlegm for RSV genetic material) increased RSV infections found by 52%. Adding blood testing increased RSV infections found by 44%. Adding mouth/throat swab PCR testing, increased RSV infections by 28%. In summary, adding additional specimen types to nasal swab PCR testing increased RSV detection. Impact of using 3 or more specimen types at the same time should be assessed, as this approach may further improve accuracy.

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Human Infection Challenge with Serotype 3 Pneumococcus.

Rationale: Streptococcus pneumoniae serotype 3 (SPN3) is a cause of invasive pneumococcal disease and associated with low carriage rates. Following the introduction of pediatric 13-valent pneumococcal conjugate vaccine (PCV13) programs, SPN3 declines are less than other vaccine serotypes and incidence has increased in some populations coincident with a shift in predominant circulating SPN3 clade, from I to II. A human challenge model provides an effective means for assessing the impact of PCV13 on SPN3 in the upper airway. Objectives: To establish SPN3's ability to colonize the nasopharynx using different inoculum clades and doses, and the safety of an SPN3 challenge model. Methods: In a human challenge study involving three well-characterized and antibiotic-sensitive SPN3 isolates (PFESP306 [clade Ia], PFESP231 [no clade], and PFESP505 [clade II]), inoculum doses (10,000, 20,000, 80,000, and 160,000 cfu/100 µl) were escalated until maximal colonization rates were achieved, with concurrent acceptable safety. Measurement and Main Results: Presence and density of experimental SPN3 nasopharyngeal colonization in nasal wash samples, assessed using microbiological culture and molecular methods, on Days 2, 7, and 14 postinoculation. A total of 96 healthy participants (median age 21, interquartile range 19-25) were inoculated (n = 6-10 per dose group, 10 groups). Colonization rates ranged from 30.0-70.0% varying with dose and isolate. 30.0% (29/96) reported mild symptoms (82.8% [24/29] developed a sore throat); one developed otitis media requiring antibiotics. No serious adverse events occurred. Conclusions: An SPN3 human challenge model is feasible and safe with comparable carriage rates to an established Serotype 6B human challenge model. SPN3 carriage may cause mild upper respiratory symptoms.

A novel approach to estimate the local population denominator to calculate disease incidence for hospital-based health events in England.

While incidence studies based on hospitalisation counts are commonly used for public health decision-making, no standard methodology to define hospitals' catchment population exists. We conducted a review of all published community-acquired pneumonia studies in England indexed in PubMed and assessed methods for determining denominators when calculating incidence in hospital-based surveillance studies. Denominators primarily were derived from census-based population estimates of local geographic boundaries and none attempted to determine denominators based on actual hospital access patterns in the community. We describe a new approach to accurately define population denominators based on historical patient healthcare utilisation data. This offers benefits over the more established methodologies which are dependent on assumptions regarding healthcare-seeking behaviour. Our new approach may be applicable to a wide range of health conditions and provides a framework to more accurately determine hospital catchment. This should increase the accuracy of disease incidence estimates based on hospitalised events, improving information available for public health decision making and service delivery planning.

Incidence of Staphylococcus aureus Infections After Elective Surgeries in US Hospitals.

BACKGROUND: Although Staphylococcus aureus is a leading cause of postsurgical infections, national estimates of these infections after elective surgeries based on microbiology data are limited. This study assessed cumulative 180-day postsurgical S. aureus incidence in real-world hospital settings. METHODS: A retrospective study of adults (≥18 years) undergoing inpatient or hospital-based outpatient elective surgeries from 1/7/2010-30/6/2015 at hospitals (N = 181) reporting microbiology results in the Premier Healthcare Database (PHD). 86 surgical categories were identified from the National Healthcare Safety Network procedures. We classified positive S. aureus cultures using a hierarchy (bloodstream [BSI], surgical site [SSI], and all other types [urinary tract, respiratory, other/unknown site]) and calculated incidence (number of infections divided by the number of elective surgery discharges). We estimated national infection case volumes by multiplying incidence by national inpatient elective surgical discharge estimates using the entire PHD and weights based on hospital characteristics. RESULTS: Following 884 803 inpatient elective surgical discharges, 180-day S. aureus infection incidence was 1.35% (0.30% BSI, 0.74% SSI no BSI, 0.32% all other types only). Among 1 116 994 hospital-based outpatient elective surgical discharges, 180-day S. aureus incidence was 1.19% (0.25% BSI, 0.75% SSI no BSI, 0.19% all other types only). Methicillin resistance was observed in ~45% of the S. aureus infections. We estimated 55 764 S. aureus postsurgical infections occurred annually in the US following 4.2 million elective inpatient surgical discharges. CONCLUSIONS: The high burden of S. aureus infections after both inpatient and outpatient elective surgeries highlights the continued need for surveillance and novel infection prevention efforts.

Epidemiology of Invasive Escherichia coli Infection and Antibiotic Resistance Status Among Patients Treated in US Hospitals: 2009-2016.

BACKGROUND: Published data is limited on the prevalence and risk of recurrence of extraintestinal invasive Escherichia coli infections (IEIs) in the United States. METHODS: The analysis included all inpatient and hospital-based outpatient visits occurring between 2009 and 2016 at hospitals with continuous microbiology data submission to the Premier Healthcare Database for 90 days before and 12 months after the admission or visit. IEI was defined as having positive E. coli culture from a normally sterile site (eg, blood, cerebrospinal fluid). The prevalence of IEI, 12-month risk of recurrent IEI, and antibiotic resistance were assessed. RESULTS: Overall, 144 944 725 hospital visits among 37 207 510 patients were analyzed, and 71 909 IEI events occurred in 67 583 patients, corresponding to an IEI prevalence of 0.50 events per 1000 visits and 1.82 events per 1000 patients. Recurrence was common: 26.9 per 1000 patients had a recurrent IEI in the 12 months after their infection. Most infections were community acquired (66.4%), and urosepsis was most common clinical syndrome (66.0%). The 30-day risk of IEI among patients undergoing transrectal ultrasound-guided prostate biopsy was high: 5.03 events per 1000 patients. Among all IEI cases with antibiotic susceptibility testing, 9.18% were resistant to extended-spectrum cephalosporins, 28.22% to fluoroquinolones, and 0.14% to carbapenems. Resistance to extended-spectrum cephalosporins increased from 5.46% to 12.97% during the 8-year study period. CONCLUSIONS: This real-world study indicates a substantial burden of IEI and recurrent IEI exists in the United States, as well as increasing resistance to extended-spectrum cephalosporins. Future research should explore risk factors of recurrent IEI aiming to effectively prevent such infections.

The incidence of stroke among selected patients undergoing elective posterior lumbar fusion: a retrospective cohort study.

BACKGROUND: Although stroke is a rare complication among spinal surgery patients, the recognition of this adverse event is critical given the aging population undergoing surgical procedures. The objective of this study was to estimate the incidence of stroke among selected adults undergoing elective posterior lumbar fusion (PLF) during various post-operative risk windows and among different subgroups. METHODS: A retrospective cohort study using a longitudinal electronic healthcare record (EHR) database was conducted from January 1, 2007 to June 30, 2018. Elective PLF, stroke, and select clinical characteristics were defined based on International Classification of Disease codes. Patients aged 18 to 85 years with ≥183 days of enrollment in the database prior to undergoing elective PLF were followed from the index date until the occurrence of stroke, death, loss to follow-up, or end of study period, whichever occurred first. The incidence of stroke was estimated in the following risk windows: index hospitalization, ≤ 30 days, ≤ 90 days, ≤ 180 days, and ≤ 365 days post-operation. RESULTS: A total of 43,063 patients were eligible for the study. The incidence of stroke following elective PLF was 0.29% (95% confidence interval [CI]: 0.25, 0.35%) during index hospitalization, 0.44% (95% CI: 0.38, 0.50%) ≤ 30 days, 0.59% (95% CI: 0.52, 0.67%) ≤ 90 days, 0.76% (95% CI: 0.68, 0.85%) ≤ 180 days, and 1.12% (95% CI: 1.03, 1.23%) ≤ 365 days post-operation. Stratified analyses revealed that older patients had a higher incidence of stroke. Additionally, black patients had higher stroke incidences. Post-operative stroke incidence was higher among patients with a history of type 2 diabetes than among patients without such history; similarly, stroke incidence was higher among patients with a history of stroke compared to patients without such history. CONCLUSIONS: The incidence of stroke following elective PLF using an EHR database in this study is slightly higher than that reported in the literature. Our results suggest that stroke risk modification prior to PLF may be important for patients who are older, black, type 2 diabetic, and/or have a history of stroke.

Implications for Improving Fetal Death Vital Statistics: Connecting Reporters' Self-Identified Practices and Barriers to Third Trimester Fetal Death Data Quality in New York City.

OBJECTIVES: Perinatal mortality prevention strategies that target fetal deaths often utilize vital records data sets shown to contain critical quality deficiencies. To understand the causes of deficient data, we linked survey responses of fetal death reporters with facility fetal death data quality indicators. METHODS: In 2011, we surveyed the person most responsible for fetal death reporting at New York City healthcare facilities on their attitudes, barriers, and practices regarding reporting. We compared responses by 2 facility data quality indicators (data completeness and ill-defined cause of fetal death) for third trimester fetal death registrations using Chi squared tests. RESULTS: Thirty-nine of 50 facilities completed full questionnaires (78 % response rate); responding facilities reported 84 % (n = 11,891) of all 2011 fetal deaths, including 329 third trimester fetal deaths. Facilities citing ≥1 reporting barrier were approximately five times more likely to have incomplete third trimester registrations than facilities citing no substantial barriers (37.5 vs 7.9 %; RR 4.7; 95 % CI [1.6-14.2]). Reported barriers included onerous reporting requirements (n = 10; 26 %) and competing physician priorities (n = 11; 28 %). Facilities citing difficulty involving physicians in reporting were more likely to report fetal deaths with nonspecific cause-of-death information (70.9 vs 56.6 %; RR 1.3; 95 % CI [1.1-1.5]). CONCLUSIONS: Self-reported challenges correlate with completeness and accuracy of reported fetal death data, suggesting that such barriers are likely contributing to low quality data. We identified several improvement opportunities, including in-depth training and reducing the information collected, especially for early fetal deaths (<20 weeks' gestation), the majority of events reported.

Increased Life Expectancy in New York City, 2001-2010: An Exploration by Cause of Death and Demographic Characteristics.

OBJECTIVE: New York City's (NYC's) life expectancy gains have been greater than those seen nationally. We examined life-expectancy changes over the past decade in selected NYC subpopulations and explored which age groups and causes of death contributed most to the increases. METHODS: We calculated life expectancy with 95% confidence intervals (CIs) for 2001-2010 by sex and race/ethnicity. Life expectancy was decomposed by age group and cause of death. Logistic regressions were conducted to reinforce the results from decomposition by controlling confounders. RESULTS: Overall, NYC residents' life expectancy at birth increased from 77.9 years (95% CI, 77.8-78.0) in 2001 to 80.9 years (95% CI, 80.8-81.0) in 2010. Decreases in deaths from heart disease, cancer, and HIV disease accounted for 50%, 16%, and 11%, respectively, of the gains. Decreased mortality in older age groups (≥65 years) accounted for 45.6% of the overall change. CONCLUSIONS: Life expectancy increased for both sexes, across all racial/ethnic groups, and for both the US-born and the foreign-born. Disparities in life expectancy decreased as overall life expectancy increased. Decreased mortality among older adults and from heart disease, cancer, and HIV infection accounted for most of the increases.

Evaluating the Use of an Electronic Death Registration System for Mortality Surveillance During and After Hurricane Sandy: New York City, 2012.

OBJECTIVES: We evaluated the use of New York City's (NYC's) electronic death registration system (EDRS) to conduct mortality surveillance during and after Hurricane Sandy. METHODS: We used Centers for Disease Control and Prevention guidelines for surveillance system evaluation to gather evidence on usefulness, flexibility, stability, timeliness, and quality. We assessed system components, interviewed NYC Health Department staff, and analyzed 2010 to 2012 death records. RESULTS: Despite widespread disruptions, NYC's EDRS was stable and collected timely mortality data that were adapted to provide storm surveillance with minimal additional resources. Direct-injury fatalities and trends in excess all-cause mortality were rapidly identified, providing useful information for response; however, the time and burden of establishing reports, adapting the system, and identifying indirect deaths limited surveillance. CONCLUSIONS: The NYC Health Department successfully adapted its EDRS for near real-time disaster-related mortality surveillance. Retrospective assessment of deaths, advanced methods for case identification and analysis, standardized reports, and system enhancements will further improve surveillance. Local, state, and federal partners would benefit from partnering with vital records to develop EDRSs for surveillance and to promote ongoing evaluation.

Repeat abortions in New York City, 2010.

This study aims to describe factors associated with the number of past abortions obtained by New York City (NYC) abortion patients in 2010. We calculated rates of first and repeat abortion by age, race/ethnicity, and neighborhood-level poverty and the mean number of self-reported past abortions by age, race/ethnicity, neighborhood-level poverty, number of living children, education, payment method, marital status, and nativity. We used negative binomial regression to predict number of past abortions by patient characteristics. Of the 76,614 abortions reported for NYC residents in 2010, 57% were repeat abortions. Repeat abortions comprised >50% of total abortions among the majority of sociodemographic groups we examined. Overall, mean number of past abortions was 1.3. Mean number of past abortions was higher for women aged 30-34 years (1.77), women with ≥5 children (2.50), and black non-Hispanic women (1.52). After multivariable regression, age, race/ethnicity, and number of children were the strongest predictors of number of past abortions. This analysis demonstrates that, although socioeconomic disparities exist, all abortion patients are at high risk for repeat unintended pregnancy and abortion.

How well do birth records serve maternal and child health programs? Birth registration system evaluation, New York City, 2008-2011.

National birth registration guidelines were revised in 2003 to improve data quality; however, few studies have evaluated the impact on local jurisdictions and their data users. In New York City (NYC), approximately 125,000 births are registered annually with the NYC Department of Health and Mental Hygiene, and data are used routinely by the department's maternal and child health (MCH) programs. In order to better meet MCH program needs, we used Centers for Disease Control and Prevention guidelines to assess birth data usefulness, simplicity, data quality, timeliness and representativeness. We interviewed birth registration and MCH program staff, reviewed a 2009 survey of birth registrars (n = 39), and analyzed 2008-2011 birth records for timeliness and completeness (n = 502,274). Thirteen MCH programs use birth registration data for eligibility determination, needs assessment, program evaluation, and surveillance. Demographic variables are used frequently, nearly 100 % complete, and considered the gold standard by programs; in contrast, medical variables' use and validity varies widely. Seventy-seven percent of surveyed birth registrars reported ≥1 problematic items in the system; 64.1 % requested further training. During 2008-2011, the median interval between birth and registration was 5 days (range 0-260 days); 11/13 programs were satisfied with timeliness. The NYC birth registration system provides local MCH programs useful, timely, and representative data. However, some medical items are difficult to collect, of low quality, and rarely used. We recommend enhancing training for birth registrars, continuing quality improvement efforts, increasing collaboration with program users, and removing consistently low-quality and low-use variables.

Effect of cause-of-death training on agreement between hospital discharge diagnoses and cause of death reported, inpatient hospital deaths, New York City, 2008-2010.

INTRODUCTION: Accurate cause-of-death reporting is required for mortality data to validly inform public health programming and evaluation. Research demonstrates overreporting of heart disease on New York City death certificates. We describe changes in reported causes of death following a New York City health department training conducted in 2009 to improve accuracy of cause-of-death reporting at 8 hospitals. The objective of our study was to assess the degree to which death certificates citing heart disease as cause of death agreed with hospital discharge data and the degree to which training improved accuracy of reporting. METHODS: We analyzed 74,373 death certificates for 2008 through 2010 that were linked with hospital discharge records for New York City inpatient deaths and calculated the proportion of discordant deaths, that is, death certificates reporting an underlying cause of heart disease with no corresponding discharge record diagnosis. We also summarized top principal diagnoses among discordant reports and calculated the proportion of inpatient deaths reporting sepsis, a condition underreported in New York City, to assess whether documentation practices changed in response to clarifications made during the intervention. RESULTS: Citywide discordance between death certificates and discharge data decreased from 14.9% in 2008 to 9.6% in 2010 (P < .001), driven by a decrease in discordance at intervention hospitals (20.2% in 2008 to 8.9% in 2010; P < .001). At intervention hospitals, reporting of sepsis increased from 3.7% of inpatient deaths in 2008 to 20.6% in 2010 (P < .001). CONCLUSION: Overreporting of heart disease as cause of death declined at intervention hospitals, driving a citywide decline, and sepsis reporting practices changed in accordance with health department training. Researchers should consider the effect of overreporting and data-quality changes when analyzing New York City heart disease mortality trends. Other vital records jurisdictions should employ similar interventions to improve cause-of-death reporting and use linked discharge data to monitor data quality.

Understanding perinatal death: a systematic analysis of New York City fetal and neonatal death vital record data and implications for improvement, 2007-2011.

We aimed to compare demographic, medical, and cause-of-death information reported for third-trimester fetal and neonatal death vital records collected in New York City (NYC) before and after implementation of the revised fetal death certificate to identify: (1) the limitations of combining fetal and neonatal death records for the purpose of perinatal death prevention; and (2) improvement opportunities for fetal death vital records registration. Using Chi squared tests, we compared data completeness and cause-of-death information between third-trimester NYC fetal (n = 1,930) and neonatal deaths (n = 735) from 2007 to 2011. We also compared fetal death data before and after the 2011 implementation of the 2003 United States (US) Standard Report of Fetal Death and an electronic reporting system. Compared with neonatal deaths, fetal death data were generally less complete (P < 0.0001). Fetal death data much more frequently reported an ill-defined cause of death (67 vs. 5 %). Most ill-defined reported causes of fetal death (73 %) were attributed to stillbirth synonyms (e.g., "fetal demise"). Ill-defined causes of fetal death decreased from 68 to 61 % (P < 0.01) after 2011. Both data completeness and ill-defined causes of death varied widely by hospital. In NYC, fetal deaths lack demographic, medical, and cause-of-death information compared with neonatal deaths, with implications for research that uses combined perinatal mortality data sets. Electronic implementation of the US Standard Report of Fetal Death minimally improved cause-of-death information. Substantial variability by hospital suggests opportunities for improvement exist.

Test of an electronic program to query clinicians about nonspecific causes reported for pneumonia deaths, New York City, 2012.

We tested an electronic cause-of-death query system at a hospital in New York City to evaluate clinicians' reporting of cause of death. We used the system to query clinicians about all deaths assigned International Classification of Disease code J189 (pneumonia, unspecified) as the underlying cause of death. Of 29 death certificates that generated queries, 28 were updated with additional information, which led to revisions in the underlying cause of 27 deaths. The electronic system for querying reported cause of death was feasible and enabled quicker than usual responses; however, follow-up with clinicians to ensure timely, accurate, and complete responses was labor-intensive. Educating clinicians and enforcing reporting standards would reduce the time and effort required to ensure accurate and timely cause-of-death reporting.