Standard Schedule Research Articles

Immune response to GeneVac-B® (rDNA I.P. hepatitis B vaccine) in vaccinated persons with a standard schedule in Bobo-Dioulasso, Burkina Faso

Immune response to GeneVac-B® (rDNA I.P. hepatitis B vaccine) in vaccinated persons with a standard schedule in Bobo-Dioulasso, Burkina Faso

Navigating Reproductive Care in Patients With Inflammatory Bowel Disease: A Comprehensive Review.

Inflammatory bowel disease [IBD] is often diagnosed in patients during their reproductive years. It is crucial that both healthcare providers and patients are adequately informed to avoid misguided decisions regarding family planning. One of the most important aspects during conception and pregnancy is to maintain disease remission, as disease activity is associated with adverse pregnancy outcomes. Apart from methotrexate, most conventional drugs used in IBD are considered low risk during conception and pregnancy. For newer agents, evidence is still limited. If needed, surgery must not be postponed and should ideally be performed in specialized centres. In most patients, delivery should be vaginal except for patients with complex perianal disease, with an ileoanal pouch anastomosis, or if there is an obstetric contraindication. In children exposed to biological treatments during pregnancy, the risk of infections appears to be low, and psychomotor development is probably not affected. Regarding immunizations, the standard vaccination schedule for inactivated vaccines should be followed for children exposed to biologics in utero. In the case of live vaccines, such as rotavirus, decisions should be individualized and take into consideration the risk-benefit ratio, particularly in developing countries. In this review, we provide a comprehensive and updated overview of aspects related to fertility, pregnancy, breastfeeding, and the impact on the care of children born to mothers with IBD. Both the available evidence and areas of uncertainty are discussed, with the goal of assisting healthcare professionals caring for IBD patients during this important stage of their lives.

On-line evaluation of moisture transfer properties for a feed-forward control of a wood drying kiln with a mechanistic model

Kiln operators are forced to rely on their own experience and expertise when adapting standard drying schedules to tackle changing situations or to better suit their needs. The online tuning of a mechanistic model and its use as forward control is therefore proposed to address the current lack of tools. An inverse analysis of the drying kinetics of wooden boards dried in an industrial kiln is carried out to determine the moisture transfer properties of the boards. The values obtained by the inverse method are found to be relatively close to those obtained by direct measurement. The mechanistic model is then used with these input values to simulate the drying of a stack of boards to find the best drying strategy to meet the objectives. This work focuses on achieving a compromise between quality and time. Several difficulties were encountered in developing this approach for a semi-industrial dryer, and some recommendations are made for developing this innovative strategy further.

Effectiveness of Use Partograph during Labour among Staff Nurses

Events such as pregnancy and childbirth affect almost every fact of the human experience. Pregnancy alters a woman's body and mind. A partogram, also known as a partograph, is a single sheet of paper that has a composite graphical record of important labor-related data (fetal and maternal) entered against time. Statistics like cervical dilation, fetal heart rate, labor time, and vital signs are examples of pertinent metrics. The partograph is an invaluable tool for identifying indicators of maternal anxiety, irregular labor progress, and fetal distress. The partograph is intended to record the following: the mother's identity, the fetal heart rate, the color of the amniotic fluid, the fetal skull's molding, cervical dilatation, the fetal descent, the uterine contractions, and whether oxytocin was given or not.  Objectives: Determine staff nurses in the experimental and control groups' degree of expertise & efficiency about using partograph during labor.  Methodology:  Research Design: True experimental research design used in study,  Sampling technique & Population. . A basic random sample procedure was used to choose the 60 staff nurses for the study (30 in the experimental group and 30 in the control group). A study was conducted using a standardized interview schedule. .  Result: In experimental group of staff nurses had 70% of adequate knowledge about partograph in post test and in control group 30 % of staff nurses only have adequate knowledge about partograph in post test .  Conclusion The study helped the researcher to finalize the importance & use of partograph in labour among staff nurses in progress of labour. partograph is an invaluable tool for identifying indicators of maternal anxiety, irregular labor progress, and fetal distress.

A-195 Combination of Lean Mindset, Robotics and Digitalization allowed us to manage a 2.5 times increase in workload in our central reference lab

Abstract Background Our Agilus Diagnostics, Gurugram, India is a Central Reference Laboratory and part of the pan-India network over 400 lab in India. Our Gurugram lab delivers 3,200 tubes in the serum work area in 17 hour operations daily and is ISO 15189 and CAP accredited.In Jan 2023, our lab started to support Govt PHC Program samples and our workload increased to 8000 tubes. This was a clear operational and clinical challenge for us with a 2.5 x jump in workload. To achieve this goal, a lean mindset with process improvement steps were to be applied required across the total testing process. This lean approach was supported by cobas ® Lab Automation systems managed by navify ® Lab Operations informatics automation solution. This poster explains our journey of planning, implementing, and delivering on our goal of predictable operational efficiency when faced with this challenge. Methods We took 4 major steps We redesigned lab processes using lean process improvement operational dashboards. This poster will show the metric we track which help eliminate waste in the system. We optimized our total lab automation solution with smart load balancing across cobas ® Pro integrated analyzers and staff friendly recursive workflow. Clear and strict use of off peak hours for maintenance and QC procedures and standardized predictable schedule of operation. This poster will share our time table with key milestones across the 24 hours We built on the Informatics solution using 5 layered Auto verification rules based decision framework. IQC, Systems Flags check, Sample Quality checks, Biological Reference check, custom Auto verification Range, Critical ranges Delta check Criteria, Clinical Correlation Rule are all part of the auto verification logic framework. Results We were able to deliver the following results.Lean process design led to 53% simplification. Number of process steps reduced to 29 from 62 steps across the total testing process. Total Lab Automation has helped improve 90 percentile production TAT by 46% from 250 mins to 135 mins Our 90 % TAT CV has significantly reduced making our production predictable. Over 17,500 results / day reported are subject to auto verification with 87 % of all results auto-verified and auto-approved. Not a single additional employee was added in the analytical or post analytical areas of the lab operations Conclusions Lean Mindset complemented by Total Laboratory Automation along with Decision Automation on an Informatics solution has enhanced lab performance in terms of TAT, Efficiency, and Staff Motivation. This poster will also demonstrate using incremental effectiveness analysis comparative data of key performance indicators, such predictability in production, and efficiency of workforce, senior staff time saved, before and after technology deployment. The challenge of increase in sample workload is real in India and this approach allows for a sustainable way to ensure patient impact with minimum burden on our workforce.

The current status and development of nerve repair techniques for bilateral vocal cord paralysis

The related research of nerve repair for bilateral vocal cord paralysis（BVCP） can be traced back to a century ago. There is still no standardized surgical therapeutic schedule and the evaluation of curative effect, due to the variability and complexity of laryngeal nerve innervation. Otolaryngologists have been constantly weighing and improving the surgical plan in relieving airway obstruction, maintaining vocal function and reducing cough to protect the normal physiological function of the larynx. Different medical institutions have great differences in the treatment methods. Many studies and literatures were published on the treatment of BVCP, yet have few related works on the application of it's nerve repair technology presently. The research progress of nerve repair technology for BVCP were described, along with its developing trend, aiming to lay the foundation for the future technical exploration and development.

Seroprotection achieved with standard four-dose schedule of hepatitis B vaccine in people with chronic kidney disease: A real-life data

Seroprotection achieved with standard four-dose schedule of hepatitis B vaccine in people with chronic kidney disease: A real-life data

Investigating innovations in outpatient services: a mixed-methods rapid evaluation.

Within outpatient services, a broad range of innovations are being pursued to better manage care and reduce unnecessary appointments. One of the least-studied innovations is Patient-Initiated Follow-Up, which allows patients to book appointments if and when they need them, rather than follow a standard schedule. To use routine national hospital data to identify innovations in outpatient services implemented, in recent years, within the National Health Service in England. To carry out a rapid mixed-methods evaluation of the implementation and impact of Patient-Initiated Follow-Up. The project was carried out in four sequential workstreams: (1) a rapid scoping review of outpatient innovations; (2) the application of indicator saturation methodology for scanning national patient-level data to identify potentially successful local interventions; (3) interviews with hospitals identified in workstream 2; and (4) a rapid mixed-methods evaluation of Patient-Initiated Follow-Up. The evaluation of Patient-Initiated Follow-Up comprised an evidence review, interviews with 36 clinical and operational staff at 5 National Health Service acute trusts, a workshop with staff from 13 National Health Service acute trusts, interviews with four patients, analysis of national and local data, and development of an evaluation guide. Using indicator saturation, we identified nine services with notable changes in follow-up to first attendance ratios. Of three sites interviewed, two queried the data findings and one attributed the change to a clinical assessment service. Models of Patient-Initiated Follow-Up varied widely between hospital and clinical specialty, with a significant degree of variation in the approach to patient selection, patient monitoring and discharge. The success of implementation was dependent on several factors, for example, clinical condition, staff capacity and information technology systems. From the analysis of national data, we found evidence of an association between greater use of Patient-Initiated Follow-Up and a lower frequency of outpatient attendance within 15 out of 29 specialties and higher frequency of outpatient attendance within 7 specialties. Four specialties had less frequent emergency department visits associated with increasing Patient-Initiated Follow-Up rates. Patient-Initiated Follow-Up was viewed by staff and the few patients we interviewed as a positive intervention, although there was varied impact on individual staff roles and workload. It is important that sites and services undertake their own evaluations of Patient-Initiated Follow-Up. To this end we have developed an evaluation guide to support trusts with data collection and methods. The Patient-Initiated Follow-Up evaluation was affected by a lack of patient-level data showing who is on a Patient-Initiated Follow-Up pathway. Engagement with local services was also challenging, given the pressures facing sites and staff. Patient recruitment was low, which affected the ability to understand experiences of patients directly. The study provides useful insights into the evolving national outpatient transformation policy and for local practice. Patient-Initiated Follow-Up is often perceived as a positive intervention for staff and patients, but the impact on individual outcomes, health inequalities, wider patient experience, workload and capacity is still uncertain. Further research should include patient-level analysis to determine clinical outcomes for individual patients on Patient-Initiated Follow-Up and health inequalities, and more extensive investigation of patient experiences. This study is registered with the Research Registry (UIN: researchregistry8864). This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 16/138/17) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 38. See the NIHR Funding and Awards website for further award information.

Flexible Job Shop Scheduling Problem-Solving Using Apiary Organizational-Based Optimization Algorithm

Flexible job shop scheduling problem (FJSSP) is a complex and challenging problem that plays a crucial role in industrial and manufacturing production. FJSSP is an expansion of the standard job shop scheduling problem (JSSP). One of FJSSP’s objectives that the manufacturing system competing for is minimizing the makespan. This paper uses a new nature-inspired metaheuristic optimization algorithm called the Apiary Organizational-Based Optimization algorithm (AOOA) to solve the FJSSP. This Algorithm simulates the organizational behavior of honeybees inside the apiary and translates their activities and vital processes during their lifecycle into phases that can solve such NP-hard problems. Two benchmark datasets, Brandimarte and Hurink, with 10 MK instances and 24 (edata, rdata, and vdata) instances respectively, were used to demonstrate the ability of AOOA to solve FJSSP. Moreover, the results of AOOA were compared with a set of state-of-the-art algorithms and statistically measured using the paired samples t-test and p-value, RPD, and group-based superiority statistical analysis to test its performance. AOOA outperformed Elitism GA, Enhanced GA, Improved GA, and MOGWO in solving all 10 MK instances and HICSA in solving 9 MK instances out of 10. Moreover, AOOA overcame CS, CS-BNG, CS-ILF, CHA, and MCA in solving 24, 12, 12, 23, and 24 instances of edata, rdata, and vdata, respectively. AOOA proved its robustness, showing promising outcomes.

Comparative Immunogenicity of a High-Dose Hepatitis B Virus (HBV) Vaccine with Rapid Immunization vs. Standard Schedule in HBV Vaccine-Naïve Adults Aged 25-55 in China.

The 20 μg (0-1-6 month) hepatitis B virus (HBV) vaccination is widely recommended for HBV vaccine-naïve immune adults in China. However, suboptimal protective responses may occur due to dose-series incompletion. We aim to investigate the immunogenicity of a 60 μg HB vaccine with a 0-2 month series among HBV vaccine-naïve immune adults aged 25-55 to assess potential alternative approaches for HB immunization. A two-center randomized controlled trial was carried out. Participants were randomly allocated to either the 20 μg (0-1-6 month) or the 60 μg (0-2 month) regimen. Blood samples were collected eight weeks after the final injection to measure the antibodies. A total of 583 adults (289 in the 20 μg regimen and 294 in the 60 μg regimen) were included. The seroprotection rates (SPRs) were 97.23% and 93.54% in the 20 μg and 60 μg regimens, respectively (p = 0.0261), and the geometric mean concentrations were 600.76 mIU/mL and 265.68 mIU/mL, respectively (p < 0.0001). The immunogenicity of the 60 μg regimen decreased significantly with age, particularly in adults aged 40 and older. The 60 μg regimen may be beneficial for adults under 40, especially those with poor compliance or in urgent need of immunization.

72 Impact of microbiome modulation on serum cytokine profile in a randomized, phase I trial of cabozantinib/nivolumab (cabo/nivo) with or without CBM588 in pts with metastatic renal cell carcinoma (mRCC)

Abstract Background We have previously demonstrated that the orally administered, live bacterial product CBM588 can augment clinical outcomes with cabo/nivo in pts with mRCC (Ebrahimi et al ASCO 2023). As it is postulated this effect may be mediated through changes in systemic immunity, we sought to characterize changes in serum cytokine profile induced by CBM588. Methods Pts with previously untreated mRCC with clear cell, papillary or sarcomatoid histology were enrolled. Key eligibility criteria included Karnofsky performance status ≥ 70% and measurable disease. Pts were randomized to receive cabo/nivo on a standard schedule alone or the same regimen with CBM588 at 80 mg bid. Pts had blood collection performed at baseline and at weeks 9, 13, 17 and 25. Samples underwent processing within 4-6 hrs of collection, and a total of 30 cytokines and growth factors were assessed using the Luminex Flexmap 3D system (Biotechne). Changes in circulating cytokine levels between baseline and week 13 (± 7 days) were examined across the treatment arms to investigate the impact of CBM588 on the immune system. The Wilcoxon matched-pairs test was used to compare the levels of cytokines at the two timepoints. Results A total of 30 pts were enrolled; the majority were male (67%) and had intermediate- or poor-risk disease (60%). Most pts had clear cell histology (87%); 5 pts (17%) had sarcomatoid features. As previously reported, pts receiving cabo/nivo/CBM588 had a significantly higher response rate as compared to pts receiving cabo/nivo alone (74% vs 20%; P=0.01). Across baseline and week 13, a total of 53 samples were available for assessment. In pts receiving cabo/nivo/CBM588, there was a significant change in the level of IL-12, IL-13, eotaxin, interferon-γ, and granulocyte-macrophage colony stimulating factor (GM-CSF); this was not observed in the cabo/nivo alone arm. Additional flow cytometric analyses characterizing relevant CD4- and CD8-positive subsets will be presented. Conclusions Taken together with our previous study evaluating nivolumab/ipilimumab with CBM588 (Dizman et al Nat Med 2022), these results suggest that the augmented clinical outcome seen with the addition of CBM588 to cabo/nivo may be related to systemic immunomodulation. Combined analyses of the cohorts across studies are planned.

Efficacy of Vaccination and Revaccination Against Hepatitis B Virus Using 2 Different Strategies in Patients With Inflammatory Bowel Disease.

Patients with inflammatory bowel disease (IBD) exhibit an increased risk for acquiring hepatitis B virus (HBV), thus they should be vaccinated preferably, if not already infected or immunized. We assessed the efficacy of HBV vaccination in IBD patients and impact of different factors on the immune response. We also evaluated the success rate of 2 different revaccination strategies in the nonresponders. This was a retrospective observational cohort study carried out in 5 tertiary centers. All patients were tested for hepatitis B surface antigen, antibodies against hepatitis B surface antigen (anti-HBs), and antibodies against hepatitis B core antigen. Patients tested negative and underwent the standard schedule with 20 µg at 0, 1, and 6 months. Nonresponders (anti-HBs <10 IU/L) were offered a revaccination scheme with either 3 doses of 40 µg at 0, 1, and 6 months or an accelerated scheme with 20 µg at 0, 1, and 2 months. A total of 409 patients were included, and 273 (66.7%) of those (females: 49.5%; Crohn's disease [CD]: 56.7%) responded to baseline vaccination. A total of 189 (69.2%) of 273 (females: 48.1%; CD: 60.3%) developed anti-HBs >100 IU/L. Body mass index <30kg/m2 (P = .017) was positively associated, while diagnosis of CD (P = .013), extensive UC (P <.0001), extraintestinal manifestations (P = .001), and treatment with immunomodulators/anti-tumor necrosis factor (P < .00) negatively affected the response. Revaccination was offered to 103 patients, and 58.3% of them achieved anti-HBs >10 IU/L. Both revaccination strategies were equally effective. IBD patients demonstrate lower response to HBV vaccination compared with the general population. Age, body mass index, type, disease activity, and immunosuppression negatively affect the response. Half of nonresponders may benefit from an enhanced revaccination attempt.

Therapeutic efficacy and safety of biweekly administration of enfortumab vedotin for urothelial carcinoma.

Enfortumab vedotin (EV) is an established pharmacotherapy for metastatic urothelial carcinoma (mUC); however, its adverse events (AEs) cannot be overlooked. The study investigated the efficacy and safety of biweekly EV administration. Patients with mUC who received EV at our institution were included in the study. Eligible patients were classified into two groups as follows: those who received EV on a standard schedule (standard group) and those who received EV on a biweekly schedule (biweekly group); the treatment outcomes and AEs between the two groups were compared. Nine and 19 patients were in the standard group and biweekly groups, respectively. The progression-free survival, overall survival, and overall response rate were not significantly different between the two groups. AEs following EV administration, such as decreased appetite (P<.01), pruritus (P<.01), rash maculopapular (P<.01), anemia (P=.04), and liver dysfunction (P=.04), were significantly more frequent in the standard group. Grade 3 or higher AEs, such as pruritus (P=.03) and rash maculopapular (P<.01), were significantly more frequent in the standard group. Furthermore, significantly more patients in the standard group had to be given a reduced dose due to adverse events (P=.02). Biweekly administration of EV may be safer without compromising therapeutic efficacy than the standard schedule.

Gaussian-based plug load profile prediction in non-residential buildings archetype

This paper presents an innovative approach to addressing the prevalent challenge of simulation uncertainty in urban building energy modeling (UBEM), focusing on accurately determining occupant-related input parameters. Traditional UBEM methods typically rely on standard schedules to create archetype models, which often fail to reflect the variability observed in real-world scenarios. To overcome this limitation, this research introduces a novel framework for generating electricity use profiles in institutional building archetypes across various climate zones. This framework integrates k-means clustering with Gaussian processes, effectively incorporating uncertainties into the prediction models. The evaluation of this stochastic model suggests that the methodology can give acceptable predictions on the electricity consumption of institutional buildings. The model demonstrates robust predictive capabilities, achieving a CVRMSE as low as 11% on weekdays and 8.7% on weekends, reflecting its strong predictive performance. However, its performance varies among different clusters and time periods, with specific clusters displaying more significant predictive inaccuracies at particular times. These results emphasize the importance of fine-tuning models and offer opportunities for improvement in predicting urban building energy consumption. This can be achieved by incorporating sensor-derived data to develop more detailed building profiles that include variable electricity usage patterns. This methodology has been integrated into a UBEM tool, enabling the generation of more realistic electricity load profiles.

Comparison of Physicians' Attitudes and Practice Regarding Vaccination during Pregnancy in Turkey.

This study aimed to investigate the knowledge, attitudes, and behaviors of family physicians (FPs), pediatricians (PPs), and obstetricians and gynecologists (OGs) regarding vaccine administration during pregnancy in Turkey as factors that contribute to decision-making. The survey was distributed among FPs, OGs, and PPs, and participants were asked to rate their knowledge on specific topics using a five-point scale ranging from "Not Effective" to "Effective". The tetanus and diphtheria (Td) vaccine was highly recommended by 94.9% of physicians and considered very effective. Among the physicians surveyed, 80% of PPs and 66.0% of OGs were aware of the disease burden of pertussis. We also found that 74.5% of FPs and 77.2% of PPs believed they needed more information about vaccination during pregnancy. All physicians surveyed agreed or strongly agreed that explaining the disease risks and benefits of vaccination increases the vaccine acceptance rate. The results of this survey study indicate that the knowledge and awareness of physicians need to be improved to increase vaccination rates during pregnancy in Turkey, and it is essential to incorporate influenza and tetanus, diphtheria, and pertussis (TdaP) vaccines into the standard maternal immunization schedule for newborns.

The Impact of Smoking on Long-Term Protection Following Hepatitis B Vaccination: A 24-Year Cohort Study.

The hepatitis B vaccination-induced immune response has been demonstrated to be associated with a number of factors, including age, sex, BMI, and the presence of comorbidities. Additionally, modifiable determinants such as smoking have been identified as influencing the response to vaccination. However, despite the evidence that smokers are at an increased risk of not responding to vaccination, the long-term effects of smoking on antibody persistence remain poorly understood. This study aims to assess the impact of smoking habits on long-term immunity following the primary vaccination cycle. Participants were required to have received a standard three-dose vaccine schedule in childhood, without subsequent doses, and to be between 18 and 24 years of age. Data on age, sex, BMI, age of administration of the first vaccine dose, and time between doses were collected. An antibody concentration < 10 IU/L was considered as non-protective. A total of 2133 individuals were included, 14.2% of whom were smokers. The mean age was 20.28 ± 0.92 years. The probability of having a non-protective antibody concentration was significantly higher in smokers than in non-smokers (AOR: 1.287; 95% CI: 1.002-1.652). The detrimental effects of smoking extend beyond the immediate effects on the vaccine response, also impairing the long-term immune response in individuals who received vaccinations during childhood.

Risk Perceptions and Vulnerability Assessment: Induced from Tropical Cyclone in the Southern Part of Coastal Bangladesh

The coastal area that borders Bangladesh is extremely vulnerable to natural disasters like tropical cyclones, which cause the majority of the damage and fatalities related to flooding. This study attempts to evaluate the susceptibility of coastal flooding induced by tropical cyclones in the South-Western coastal region of Bangladesh. It also identifies the relationship between the influencing factors and respondents' perceptions of risk in terms of socio-economic characteristics. Data was gathered by using a standardized interview schedule from coastal households of three districts named as South Khali (Bagerhat), Padma Pukur (Satkhira), and Rangopaldi (Patuakhali). The survey was taken through interview to assemble information on risk perception, also explores the impact of flood risk on agriculture, environment and livelihood sectors to describe the most specific vulnerable one of different regions that provides a robust insight of affected residents. Moreover, twenty-one predominant factors in terms of three components reveal a strong relationship with severity to flood risk. Results also indicate that, vulnerability indexes differ significantly (p value &lt; 0.05) in the study areas (vulnerability index = 0.54 in South Khali, 0.77 in Padma Pukur, and 0.74 in Rangopaldi). In addition, disaster vulnerability index differs with different socio-economic and geographical factors which enhance the negative effect of flood for the coastal community. The study also reveals that, the selected area had no adequate dam and embankment, cyclone shelter as well as material support from the government and non-government organization which makes their life risky to flood. The research recommends that, generating different livelihood options, self-organization by different disaster preparedness training program to enhance their resilience, indigenous and disaster risk reduction strategies, build more coastal flood shelters and restore people’s livelihoods by supplying agricultural seeds, livestock, poultry etc. significantly minimize the vulnerability of the affected community.

Immunogenicity, reactogenicity, and IgE-mediated immune responses of a mixed whole-cell and acellular pertussis vaccine schedule in Australian infants: A randomised, double-blind, noninferiority trial.

In many countries, infant vaccination with acellular pertussis (aP) vaccines has replaced use of more reactogenic whole-cell pertussis (wP) vaccines. Based on immunological and epidemiological evidence, we hypothesised that substituting the first aP dose in the routine vaccination schedule with wP vaccine might protect against IgE-mediated food allergy. We aimed to compare reactogenicity, immunogenicity, and IgE-mediated responses of a mixed wP/aP primary schedule versus the standard aP-only schedule. OPTIMUM is a Bayesian, 2-stage, double-blind, randomised trial. In stage one, infants were assigned (1:1) to either a first dose of a pentavalent wP combination vaccine (DTwP-Hib-HepB, Pentabio PT Bio Farma, Indonesia) or a hexavalent aP vaccine (DTaP-Hib-HepB-IPV, Infanrix hexa, GlaxoSmithKline, Australia) at approximately 6 weeks old. Subsequently, all infants received the hexavalent aP vaccine at 4 and 6 months old as well as an aP vaccine at 18 months old (DTaP-IPV, Infanrix-IPV, GlaxoSmithKline, Australia). Stage two is ongoing and follows the above randomisation strategy and vaccination schedule. Ahead of ascertainment of the primary clinical outcome of allergist-confirmed IgE-mediated food allergy by 12 months old, here we present the results of secondary immunogenicity, reactogenicity, tetanus toxoid IgE-mediated immune responses, and parental acceptability endpoints. Serum IgG responses to diphtheria, tetanus, and pertussis antigens were measured using a multiplex fluorescent bead-based immunoassay; total and specific IgE were measured in plasma by means of the ImmunoCAP assay (Thermo Fisher Scientific). The immunogenicity of the mixed schedule was defined as being noninferior to that of the aP-only schedule using a noninferiority margin of 2/3 on the ratio of the geometric mean concentrations (GMR) of pertussis toxin (PT)-IgG 1 month after the 6-month aP. Solicited adverse reactions were summarised by study arm and included all children who received the first dose of either wP or aP. Parental acceptance was assessed using a 5-point Likert scale. The primary analyses were based on intention-to-treat (ITT); secondary per-protocol (PP) analyses were also performed. The trial is registered with ANZCTR (ACTRN12617000065392p). Between March 7, 2018 and January 13, 2020, 150 infants were randomised (75 per arm). PT-IgG responses of the mixed schedule were noninferior to the aP-only schedule at approximately 1 month after the 6-month aP dose [GMR = 0·98, 95% credible interval (0·77 to 1·26); probability (GMR > 2/3) > 0·99; ITT analysis]. At 7 months old, the posterior median probability of quantitation for tetanus toxoid IgE was 0·22 (95% credible interval 0·12 to 0·34) in both the mixed schedule group and in the aP-only group. Despite exclusions, the results were consistent in the PP analysis. At 6 weeks old, irritability was the most common systemic solicited reaction reported in wP (65 [88%] of 74) versus aP (59 [82%] of 72) vaccinees. At the same age, severe systemic reactions were reported among 14 (19%) of 74 infants after wP and 8 (11%) of 72 infants after aP. There were 7 SAEs among 5 participants within the first 6 months of follow-up; on blinded assessment, none were deemed to be related to the study vaccines. Parental acceptance of mixed and aP-only schedules was high (71 [97%] of 73 versus 69 [96%] of 72 would agree to have the same schedule again). Compared to the aP-only schedule, the mixed schedule evoked noninferior PT-IgG responses, was associated with more severe reactions, but was well accepted by parents. Tetanus toxoid IgE responses did not differ across the study groups. Trial registered at the Australian and New Zealand Clinical 207 Trial Registry (ACTRN12617000065392p).

Design of patient-facing immunization visualizations affects task performance: an experimental comparison of 4 electronic visualizations.

This study experimentally evaluated how well lay individuals could interpret and use 4 types of electronic health record (EHR) patient-facing immunization visualizations. Participants (n = 69) completed the study using a secure online survey platform. Participants viewed the same immunization information in 1 of 4 EHR-based immunization visualizations: 2 different patient portals (Epic MyChart and eClinicWorks), a downloadable EHR record, and a clinic-generated electronic letter (eLetter). Participants completed a common task, created a standard vaccine schedule form, and answered questions about their perceived workload, subjective numeracy and health literacy, demographic variables, and familiarity with the task. The design of the immunization visualization significantly affected both task performance measures (time taken to complete the task and number of correct dates). In particular, those using Epic MyChart took significantly longer to complete the task than those using eLetter or eClinicWorks. Those using Epic MyChart entered fewer correct dates than those using the eLetter or eClinicWorks. There were no systematic statistically significant differences in task performance measures based on the numeracy, health literacy, demographic, and experience-related questions we asked. The 4 immunization visualizations had unique design elements that likely contributed to these performance differences. Based on our findings, we provide practical guidance for the design of immunization visualizations, and future studies. Future research should focus on understanding the contexts of use and design elements that make tables an effective type of health data visualization.

Hearing loss in Australian First Nations children at 6-monthly assessments from age 12 to 36 months: Secondary outcomes from randomised controlled trials of novel pneumococcal conjugate vaccine schedules.

In Australian remote communities, First Nations children with otitis media (OM)-related hearing loss are disproportionately at risk of developmental delay and poor school performance, compared to those with normal hearing. Our objective was to compare OM-related hearing loss in children randomised to one of 2 pneumococcal conjugate vaccine (PCV) formulations. In 2 sequential parallel, open-label, randomised controlled trials (the PREVIX trials), eligible infants were first allocated 1:1:1 at age 28 to 38 days to standard or mixed PCV schedules, then at age 12 months to PCV13 (13-valent pneumococcal conjugate vaccine, +P) or PHiD-CV10 (10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine, +S) (1:1). Here, we report prevalence and level of hearing loss outcomes in the +P and +S groups at 6-monthly scheduled assessments from age 12 to 36 months. From March 2013 to September 2018, 261 infants were enrolled and 461 hearing assessments were performed. Prevalence of hearing loss was 78% (25/32) in the +P group and 71% (20/28) in the +S group at baseline, declining to 52% (28/54) in the +P groups and 56% (33/59) in the +S group at age 36 months. At primary endpoint age 18 months, prevalence of moderate (disabling) hearing loss was 21% (9/42) in the +P group and 41% (20/49) in the +S group (difference -19%; (95% confidence interval (CI) [-38, -1], p = 0.07) and prevalence of no hearing loss was 36% (15/42) in the +P group and 16% (8/49) in the +S group (difference 19%; (95% CI [2, 37], p = 0.05). At subsequent time points, prevalence of moderate hearing loss remained lower in the +P group: differences -3%; (95% CI [-23, 18], p = 1.00 at age 24 months), -12%; (95% CI [-30, 6], p = 0.29 at age 30 months), and -9%; (95% CI [-23, 5], p = 0.25 at age 36 months). A major limitation was the small sample size, hence low power to reach statistical significance, thereby reducing confidence in the effect size. In this study, we observed a high prevalence and persistence of moderate (disabling) hearing loss throughout early childhood. We found a lower prevalence of moderate hearing loss and correspondingly higher prevalence of no hearing loss in the +P group, which may have substantial benefits for high-risk children, their families, and society, but warrant further investigation. ClinicalTrials.gov NCT01735084 and NCT01174849.