Development of a COVID-19 vaccine effectiveness and safety assessment system in Japan: The VENUS study

BackgroundThere are currently no COVID-19 vaccine assessment systems in Japan that allow for the active surveillance of both vaccinated and unvaccinated persons. Herein, we describe the development of Japan’s first COVID-19 vaccine effectiveness and safety assessment system with active surveillance capabilities.MethodsThe Vaccine Effectiveness, Networking, and Universal Safety (VENUS) Study was developed as a multi-source database that links four data types at the individual resident level: Basic Resident Register (base population information), Vaccination Record System (vaccination-related information), Health Center Real-time Information-sharing System on COVID-19 (HER-SYS; information on COVID-19 occurrence), and health care claims data (information on diagnoses, hospitalizations, diagnostic tests, and treatments). These data were obtained from four municipalities. Individual residents were linked across the data types using five matching algorithms based on names, birth dates, and sex; the data were anonymized after linkage. To ascertain the viability of the VENUS Study’s database for COVID-19 vaccine assessments, we examined the trends in COVID-19 vaccinations, COVID-19 cases, and polymerase chain reaction (PCR) test numbers. We also evaluated the linkage rates across the data types.ResultsOur multi-source database was able to monitor COVID-19 vaccinations, COVID-19 cases, and PCR test numbers throughout the pandemic. Using the five algorithms, the data linkage rates between the COVID-19 occurrence information in the HER-SYS and the Basic Resident Register ranged from 85·4% to 91·7%.ConclusionIf used judiciously with an understanding of each data source’s characteristics, the VENUS Study can provide a viable data platform that facilitates active surveillance and comparative analyses for population-based research on COVID-19 vaccine effectiveness and safety in Japan.     

Effectiveness of the COVID-19 vaccines on preventing symptomatic SARS-CoV-2 infections and hospitalizations in Southwestern Alaska,January–December 2021

The population in rural southwest Alaska has been disproportionately affected by COVID-19. To assess the benefit of COVID-19 vaccines, we analyzed data from the regional health system. We estimated vaccine effectiveness (VE) during January 16–December 3, 2021, against symptomatic SARS-CoV-2 infection after a primary series or booster dose, and overall VE against hospitalization. VE of a primary series against symptomatic infection among adult residents was 91.3% (95% CI: 85.7, 95.2) during January 16–May 7, 2021, 50.3% (95% CI, 41.1%–58.8%) during July 17–September 24, and 37.0% (95% CI, 27.8–45.0) during September 25–December 3, 2021; VE of a booster dose during September 25–December 3, 2021, was 92.1% (95% CI: 87.2–95.2). During the overall study period, VE against hospitalization was 91.9% (95% CI: 85.4–95.5). COVID-19 vaccination offered strong protection against hospitalization and a booster dose restored protection against symptomatic infection.     

A retrospective cohort study investigating the comparative effectiveness of pneumococcal vaccines against hospitalisation with otitis media and pneumonia in New Zealand

BackgroundSince 2008 New Zealand has used three different formulations of pneumococcal vaccines on the national infant schedule, PCV7, PCV10 and PCV13, switching between PCV10 and PCV13 twice in 10 years. We have used New Zealand’s linkable, administrative health data to examine the comparative risk of otitis media (OM) and pneumonia hospitalisations among children receiving three different pneumococcal conjugate vaccines (PCV).MethodsThis was a retrospective cohort study using linked administrative data. Outcomes were otitis media, all cause pneumonia and bacterial pneumonia related hospitalisation for children in three cohorts representing periods where PCVs transitioned between PCV7, PCV10, PCV13 and back to PCV10 between 2011 and 2017. Cox’s proportional hazard regression was used to provide hazard ratio estimates to compare outcomes for children vaccinated with different vaccine formulations and to adjust for different sub population characteristics.ResultsEach observation period, where different vaccine formulations coincided, and therefore comparable with respect to age and the environment, included over fifty-thousand infants and children. PCV10 was associated with a reduced risk for OM compared with PCV7 (Adjusted HR 0.89, 95 %CI 0.82–0.97). There were no significant differences between PCV10 and PCV13 in risk of hospitalisation with either otitis media or all-cause pneumonia amongst the transition 2 cohort. In the 18 -month follow-up, after transition 3, PCV13 was associated with a marginally higher risk of all-cause pneumonia and otitis media compared to PCV10.ConclusionThese results should offer reassurance about the equivalence of these pneumococcal vaccines against the broader pneumococcal disease outcomes OM and pneumonia.     

Consenso de expertos sobre el uso de alemtuzumab en la práctica clínica diaria en España

IntroductionAlemtuzumab is a highly effective drug approved by the European Medicines Agency as a disease-modifying drug for the treatment of relapsing-remitting multiple sclerosis.ObjectiveA consensus document was drafted on the management of alemtuzumab in routine clinical practice in Spain.DevelopmentA group of multiple sclerosis specialists reviewed articles addressing treatment with alemtuzumab in patients with multiple sclerosis and published before December 2017. The included studies assessed the drug's efficacy, effectiveness, and safety; screening for infections and vaccination; and administration and monitoring aspects. The initial proposed recommendations were developed by a coordinating group and based on the available evidence and their clinical experience. The consensus process was carried out in 2 stages, with the initial threshold percentage for group agreement established at 80%. The final document with all the recommendations agreed by the working group was submitted for external review and the comments received were considered by the coordinating group.ConclusionThe present document is intended to be used as a tool for optimising the management of alemtuzumab in routine clinical practice.     

Transcutaneous Tibial Nerve Stimulation in the Management of Overactive Bladder: A Scoping Review

ObjectiveOveractive bladder (OAB) is a condition that has physical, social, psychosocial, and financial impacts. Transcutaneous tibial nerve stimulation (TTNS) is a modality that stimulates the nerve root fibers of L5-S3, the same spinal segments of the parasympathetic nervous system as the bladder. This scoping review aims to identify current literature available on the feasibility and outcomes of TTNS as a first-line treatment option for OAB.Materials and MethodsA scoping review of six electronic data bases was performed to identify full-text articles from 2015 that explored the impact of TTNS on OAB and bladder dysfunction in people aged >18 years.ResultsA total of 15 articles met the inclusion criteria. TTNS was compared with sham treatment, parasacral stimulation, pelvic floor muscle training (PFMT), anticholinergic medication, and percutaneous tibial nerve stimulation (PTNS). Heterogeneity in treatment application and parameters existed, with variations in treatment duration, frequency of use, and treatment settings such as pulse width (μs) and frequency (Hz). Results indicated that TTNS has efficacy equal to PFMT and PTNS in the management of OAB; however, it is not as efficacious as anticholinergic medication.ConclusionsTTNS is a promising first-line management option for people with OAB, particularly in the older population and for those with neurogenic bladder. It can provide symptomatic relief from urinary incontinence, frequency, urgency, and nocturia, while avoiding the bothersome side effects of more invasive or pharmaceutical therapies. Heterogeneity in treatment parameters limits generalizability and translation of the most appropriate clinical application and should be considered in future trials.     

Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies

Background: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients.

Objective: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice.

Methods: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered.

Results: 224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02–12.25), median OS 21.9 months (95% CI: 17.2–26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8–50.7). Median time to PR was 3.8 months (95% CI: 3.86–5.99) and to CR 8.2 months (95% CI: 4.75–9.77). The most common ≥ grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p < 0.05)

Conclusions: Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials. Long-term benefit with sunitinib is possible in advanced RCC patients but the appropriate management of toxicities is mandatory to enable patients to remain on treatment.     

Effectiveness of post-exposure prophylaxis during varicella outbreaks among primary and middle school students in Shanghai: An analysis of three-year surveillance data

ObjectivesTo evaluate the effectiveness of post-exposure prophylaxis conducted during varicella outbreaks among students in Shanghai.MethodsSurveillance data were collected from September 1, 2013 to December 31, 2016 involving 3524 susceptible students in 109 primary and middle school classes where emergency vaccinations (EVs) had been administered. Students were divided into two groups according to their prior vaccination (PV) varicella vaccine status. A secondary attack rate was used to compare EV and non-EV groups using a chi-squared test. Stratification analyses were performed, adjusting for the EV administration date, the vaccination coverage rate, and the number of cases prior to the EV.ResultsThe effectiveness rate was 92.2% (95% confidence interval (CI): 37.1–99.0%) when EV was applied within 3 days following the outbreak onset date, and 95.2% (95% CI: 79.9–98.8%) when vaccination coverage was ≥80% among students with PV. When students with PV received an EV for varicella within 3 days, the effectiveness rate was 100%.ConclusionsEV showed high protective effectiveness for varicella during outbreaks, especially if administered within 3 days of an outbreak and in conjunction with a high coverage rate.     

Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network)

BackgroundOngoing assessment of influenza vaccine effectiveness (VE) is critical to inform public health policy. This study aimed to determine the VE of trivalent influenza vaccine (TIV) for preventing influenza-related hospitalizations and other serious outcomes over three consecutive influenza seasons.MethodsThe Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) conducted active surveillance for influenza in adults ≥16 years (y) of age during the 2011/2012, 2012/2013 and 2013/2014 seasons in hospitals across Canada. A test-negative design was employed: cases were polymerase chain reaction (PCR)-positive for influenza; controls were PCR-negative for influenza and were matched to cases by date, admission site, and age (≥65 y or <65 y). All cases and controls had demographic and clinical characteristics (including influenza immunization status) obtained from the medical record. VE was estimated as 1-OR (odds ratio) in vaccinated vs. unvaccinated patients × 100%. The primary outcome was VE of TIV for preventing laboratory-confirmed influenza-related hospitalization; secondary outcomes included VE of TIV for preventing influenza-related intensive care unit (ICU) admission/mechanical ventilation, and influenza-related death.ResultsOverall, 3394 cases and 4560 controls were enrolled; 2078 (61.2%) cases and 2939 (64.5%) controls were ≥65 y. Overall matched, adjusted VE was 41.7% (95% Confidence Interval (CI): 34.4–48.3%); corresponding VE in adults ≥65 y was 39.3% (95% CI: 29.4–47.8%) and 48.0% (95% CI: 37.5–56.7%) in adults <65 y, respectively. VE for preventing influenza-related ICU admission/mechanical ventilation in all ages was 54.1% (95% CI: 39.8–65.0%); in adults ≥65 y, VE for preventing influenza-related death was 74.5% (95% CI: 44.0–88.4%).ConclusionsWhile effectiveness of TIV to prevent serious outcomes varies year to year, we demonstrate a statistically significant and clinically important TIV VE for preventing hospitalization and other serious outcomes over three seasons. Public health messaging should highlight the overall benefit of influenza vaccines over time while acknowledging year to year variability.ClinicalTrials.gov Identifier: NCT01517191.     

Systematic review of interventions delivered by UK mental health nurses

The effectiveness of mental health nurse interventions has not been generally established in the literature. In this systematic review, randomised controlled trials (RCTs) were identified, undertaken in the United Kingdom, where mental health interventions delivered by mental health nurses had been evaluated. The main online literature databases were searched, key journals were hand searched and contact was made with key authors, resulting in a total of 52 studies, involving at least 7172 service users. Data were extracted and then all identified trials were assessed for inclusion by two reviewers. The results showed that in the UK, mental health nurses are involved in the delivery of a wide range of interventions in a variety of clinical health settings, with broadly positive results.