Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

The Affordable Care Act's “community first choice” option: Effect on long-term care expenditures

Objective

To empirically assess the effect of adopting Affordable Care Act's Community First Choice (CFC) option on overall state home and community-based services (HCBS) expenditures as well as distribution of HCBS expenditures across different HCBS mechanisms. We also explore the heterogeneous effect of CFC across adopting states.

Data Source

We used data from the Medicaid Long Term Services and Support (LTSS) expenditure reports prepared by Truven Analytics and Mathematica for the Centers for Medicare & Medicaid Services from 2008–2018 for all 48 states and the District of Columbia.

Study Design

An event-study difference-in-differences model was used to estimate the effect of CFC on HCBS expenditures using Medicaid LTSS expenditure reports from 2008–2018. We also employ the synthetic control method to unmask heterogeneity across CFC adopting states using data from 2008–2018.

Data Collection/Extraction Methods

Not applicable.

Principal Findings

Overall, CFC was not associated with a change in HCBS expenditures per capita or HCBS expenditures as a proportion of LTSS expenditures. However, there appears to be an increase in HCBS expenditures among states that were institutionally-oriented prior to CFC adoption. Additionally, CFC adoption was associated with an overall decrease in expenditures in alternative HCBS mechanisms (Personal Care Services State Plan Option and 1915(c) waivers), suggesting potential substitution across overlapping programs.

Conclusion

Results indicate heterogeneity across states adopting CFC. More institutionally-oriented states appear to use CFC to expand HCBS. In contrast, more HCBS-oriented states appear to employ CFC to strategically restructure their overall portfolio and processes.     

Contemporary Epidemiology of and Risk Factors Associated with Removal of a Pathologically Normal Appendix in Children with Suspected Appendicitis

BackgroundThe goal of this study was to characterize contemporary performance benchmarks and risk factors associated with negative appendectomy (NA) in children with suspected appendicitis.MethodsA multicenter retrospective cohort analysis of children undergoing appendectomy for suspected appendicitis was performed using data from the 2016–2021 NSQIP-Pediatric Appendectomy Targeted Public Use Files. Multivariable regression was used to evaluate the influence of year, age, sex, and WBC count on NA rate, and to generate rate estimates for NA based on different combinations of demographic characteristics and WBC profiles.Results100,322 patients were included from 140 hospitals. The overall NA rate was 2.4%, and rates decreased significantly during the study period (2016: 3.1% vs. 2021: 2.3%, p < 0.001). In adjusted analyses, the highest risk for NA was associated with a normal WBC (<9000/mm³; OR 5.31 [95% CI: 4.87–5.80]), followed by female sex (OR 1.55 [95% CI: 1.42–1.68]) and age <5 years (OR 1.64 [95% CI 1.39, 1.94]). Model-estimated risk for NA varied significantly across demographic and WBC strata, with a 14.4-fold range in rates between subgroups with the lowest and highest predicted risk (males 13–17 years with elevated WBC [1.1%] vs. females 3–4 years with normal WBC [15.8%]).ConclusionsContemporary NA rates have decreased over time, however NA risk remains high in children without a leukocytosis, particularly for girls and children <5 years of age. These data provide contemporary performance benchmarks for NA in children with suspected appendicitis and identify high-risk populations where further efforts to mitigate NA risk should be targeted.Level of EvidenceIII.     

Effectiveness of Hand Hygiene Promotional Program based on the WHO Multimodal Hand Hygiene Improvement Strategy,in Terms of Compliance and Decontamination Efficacy in an Indian Tertiary Level Neonatal Surgical Intensive Care Unit

Background: The WHO Multimodal Hand Hygiene Improvement Strategy (MHHIS) has been proposed to improve the Hand Hygiene (HH) compliance of the WHO recommendations on HH.Therefore, the current study was planned in our neonatal unit with the objective of evaluating the effectiveness of a Hand Hygiene Promotional Program (HHPP) based on the WHO MHHIS, in terms of compliance and decontamination efficacy among the health-care workers (HCWs) in the unit. Objective: The objective of the study was to evaluate the effectiveness of the WHO MHHIS on HH compliance and decontamination efficacy. Methods: The HHPP was carried out in our neonatal surgical intensive care unit from July to August 2013. A pre-intervention phase consisted of assessment of ward infrastructure, HH knowledge and perception, determination of HH compliance and collection of hand rinse samples from the HCWs before and after handwashing. Intervention phase consisted of changing traditional to elbow-operated taps, display of posters and reminders, placement of soaps in water draining trays, autoclaved single-use paper towels for hand drying, availability of hand rubs and training sessions for health-care providers. In the post-intervention phase, all the assessments and observations of pre-intervention phase were repeated. Results: HHPP resulted in a significant increase in overall HH compliance from 26.6% (95% confidence interval [CI] 23.9–29.3) to 65.3% (95% CI 62.4–68.2) (P < 0.001) and reduction in load of microorganisms (P = 0.013). There was a significant improvement in HH knowledge (P < 0.001), and perception surveys revealed high appreciation of each strategy component by the participants. Conclusion: To the best of our knowledge, this is the first study about the effect of implementation of the WHO MHHIS from an Indian hospital. HHPP was found to be effective in terms of HH compliance and decontamination efficacy. Its implementation is highly recommended to promote HH in a developing country like India.     

Phase II Study of Systemic High-dose Methotrexate and Intrathecal Liposomal Cytarabine for Treatment of Leptomeningeal Carcinomatosis From Breast Cancer

Metastatic breast cancer frequently leads to brain metastases and, less commonly, leptomeningeal carcinomatosis (LC). Once cerebrospinal fluid involvement occurs, the prognosis is poor. There are limited treatment options available, but none offer significant survival benefit. Methotrexate, given systemically at high doses (3.5-8 gm/m²), achieves cytotoxic concentrations in the CSF and has been shown to prolong survival in patients with LC. Intrathecal liposomal cytarabine has been shown to increase time to neurologic progression in patients with breast cancer and LC. The combination of these 2 agents in LC has not been studied extensively. Here, we present the results of the phase II study with this combination showing promising efficacy and very good tolerability.