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Background: Severity of dyskinesia in children with cerebral palsy is often assessed using observation-based clinical tools. Instrumented methods to objectively measure dyskinesia have been proposed to improve assessment accuracy and reliability. Here, we investigated the technique and movement features that were most suitable to objectively measure the severity of dystonia in children with cerebral palsy., Methods: A prospective observational study was conducted with 12 participants with cerebral palsy with a predominant motor type of dyskinesia, spasticity, or mixed dyskinesia/spasticity who had upper limb involvement (mean age: 12.6 years, range: 6.7-18.2 years). Kinematic and electromyography data were collected bilaterally during three upper limb tasks. Spearman rank correlations of kinematic or electromyography features were calculated against dystonia severity, quantified by the Dyskinesia Impairment Scale., Findings: Kinematic features were more influential compared to electromyography features at grading the severity of dystonia in children with cerebral palsy. Kinematic measures quantifying jerkiness of volitional movement during an upper limb task with a reaching component performed best (|r s | = 0.78-0.9, p < 0.001)., Interpretation: This study provides guidance on the types of data, features of movement, and activity protocols that instrumented methods should focus on when objectively measuring the severity of dystonia in children with cerebral palsy., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier Ltd.)

There is a lack of knowledge about the accuracy of the Conventional Gait Model (CGM), compared to the true bone motion. Accuracy is hindered by both marker misplacement and soft-tissue artefact (STA). The effect of the lateral knee marker (KNE) misplacement and STA was determined from a secondary analysis of 13 subjects equipped with a total knee prothesis for which simultaneous dual-plane fluoroscopy and marker-based motion capture was available. In average, STA alone led to 3.3°, 2.9° and 6.7° errors for knee flexion, knee abduction, and the absolute hip rotation respectively. In comparison, marker misplacement led to 0.9°, 4.0° and 12.3° errors for the same kinematics. We showed that STA alone may lead to knee flexion-adduction cross-talk. This finding has clinical repercussions for the use of knee cross talk as a qualitative indicator of knee axis alignment. Our study showed that cumulative effects of marker misplacement and STA affect the transverse plane angles, making challenging to track internal/external rotation with less than 5° of errors., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using European healthcare databases. Event misclassification can result in biased estimates. Using different algorithms for identifying cases of Bordetella pertussis (BorPer) infection as a test case, we aimed to describe a strategy to quantify event misclassification, when manual chart review is not feasible., Methods: Four participating databases retrieved data from primary care (PC) setting: BIFAP: (Spain), THIN and RCGP RSC (UK) and PEDIANET (Italy); SIDIAP (Spain) retrieved data from both PC and hospital settings. BorPer algorithms were defined by healthcare setting, data domain (diagnoses, drugs, or laboratory tests) and concept sets (specific or unspecified pertussis). Algorithm- and database-specific BorPer incidence rates (IRs) were estimated in children aged 0-14 years enrolled in 2012 and 2014 and followed up until the end of each calendar year and compared with IRs of confirmed pertussis from the ECDC surveillance system (TESSy). Novel formulas were used to approximate validity indices, based on a small set of assumptions. They were applied to approximately estimate positive predictive value (PPV) and sensitivity in SIDIAP., Results: The number of cases and the estimated BorPer IRs per 100,000 person-years in PC, using data representing 3,173,268 person-years, were 0 (IR = 0.0), 21 (IR = 4.3), 21 (IR = 5.1), 79 (IR = 5.7), and 2 (IR = 2.3) in BIFAP, SIDIAP, THIN, RCGP RSC and PEDIANET respectively. The IRs for combined specific/unspecified pertussis were higher than TESSy, suggesting that some false positives had been included. In SIDIAP the estimated IR was 45.0 when discharge diagnoses were included. The sensitivity and PPV of combined PC specific and unspecific diagnoses for BorPer cases in SIDIAP were approximately 85% and 72%, respectively., Conclusion: Retrieving BorPer cases using only specific concepts has low sensitivity in PC databases, while including cases retrieved by unspecified concepts introduces false positives, which were approximately estimated to be 28% in one database. The share of cases that cannot be retrieved from a PC database because they are only seen in hospital was approximately estimated to be 15% in one database. This study demonstrated that quantifying the impact of different event-finding algorithms across databases and benchmarking with disease surveillance data can provide approximate estimates of algorithm validity., Competing Interests: Declaration of Competing Interest Caitlin Dodd, Kaatje Bollaerts, Claudia Bartolini, Giuseppe Roberto, Consuelo Huerta-Alvarez, Elisa Martín-Merino, Talita Duarte-Salles, Gino Picelli, Lara Tramontan, Giorgia Danieli, Ana Correa, Chris McGee, Benedikt Becker, Charlotte Switzer, Jorgen Bauwens, Nicoline van der Maas, Gianfranco Spiteri, Emmanouela Sdona declared no conflicts of interest. Rosa Gini declared that her institution participates in studies funded by Novartis, Eli Lilly, Daiichi Sankyo, compliant with the ENCePP Code of Conduct. Sonja Gandhi-Banga declared that she works for Sanofi Pasteur and holds company shares. Daniel Weibel declared that he has received personal fees from GSK for work unrelated to the submitted work. Miriam Sturkenboom declared that she has received grants from Novartis, CDC and Bill & Melinda Gates Foundation for work unrelated to the submitted work., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines., Methods: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009., Results: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03., Conclusions: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background and Aim: Infection with Bordetella pertussis is most severe in young infants who frequently acquire it from adults. Pertussis immunization in adults 25-29 years of age and all adults in close contact with infants <6 months was introduced in Switzerland in 2012. We immediately implemented this new recommendation in our hospital with a vaccination campaign., Methods: Between April 2012 and March 2013 we provided information about the campaign to our staff through several channels and offered appointments for counseling and immunization. After checking indications and contraindications of responding health-care personnel (HCP), informed consent for tetanus-diphtheria-acellular pertussis component (Tdap) immunization was obtained. Specific adverse events (AE) were self-assessed by standardized diaries for 7 days. Statistical analyses were performed using a t-test and Mann-Whitney U-tests SPSS (V21)., Results: Of 852 HCP eligible for pertussis immunization, 427 (51%) responded. Of these, 72 (17%) had already received Tdap <10 years ago, 304 (71%) received Tdap now, 38 (9%) were scheduled for vaccination and 12 (3%) declined. Diaries were returned by 272 (89%) of 304 vaccinees; 56 HCP reported ≥1 local AE, most frequently local swelling (8%), redness (2%), redness and swelling (7%), and fever (5=2%); no serious AE occurred., Conclusions: Comprehensive efforts were needed to achieve pertussis immunization coverage of ≥49% among all HCP in our institution. Good tolerability of the vaccine and continuous and individual information to HCP about the rationale and benefits of pertussis immunization contributed to this partial success, but increased efforts are needed to mobilize non-responding HCP., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Immunopotentiating reconstituted influenza virosomes (IRIV) are liposomes which carry the two glycoproteins of the influenza virus on their surface. A hepatitis A vaccine using IRIV as carrier has very good immunogenicity and is well tolerated. The objective of this study was to produce a fivefold combined vaccine against hepatitis A and B, diphtheria, tetanus and influenza A/B, and to show that in principle IRIVs can serve as carriers for multiple antigens which have good immunogenicity and are well tolerated. A total of four studies were carried out. Either the combined vaccine or the corresponding adequately tested alum-adsorbed single vaccines were tested for reactogenicity and immunogenicity in young adults. A hepatitis A and B combination on an IRIV base showed the same immunogenicity and toleration as the single vaccines. However, with the simultaneous coupling of all five vaccines on the same IRIV or the binding of Di-Te and HAV on different IRIVs there was a suppression of the humoral immune response against HAV (p = 0.03). The possibility that epitope-specific suppression had occurred could be ruled out. The suppression of the response against HAV could be circumvented by halving the quantity of Di-Te antigen in the combined vaccine so as to avoid antigenic competition. Surprisingly, the immunogenicity of Di-Te vaccination in the combination proved superior to that of a separate vaccination. All vaccinations were well tolerated.

In the near future an inactivated hepatitis A vaccine will be commercially available. The recommended vaccination schedule will include at least two vaccinations 1 month apart. Giving two doses of vaccine on the same day in one injection results in protection after 2-4 weeks dependent on the adjuvant used. Hepatitis A virus incorporated into liposomes proved to be a suitable formulation in term of rapid seroconversion, high level of mean antibody content and low reactogenicity.

The persistence of anti-HBs antibodies elicited in response to vaccination with a recombinant yeast-derived hepatitis B vaccine was examined. Three years after vaccination following two different schedules (0, 1, 6 months and 0, 1, 2, 12 months), anti-HBs antibody titres obtained after vaccination with the yeast-derived vaccine were similar to those observed using a plasma-derived vaccine. At this time, nearly 100% of all vaccinees had anti-HBs antibody titres over the protective limit of 10 mIU ml-1. These results suggest that the yeast-derived vaccine will confer protection against hepatitis B infection for about the same length of time as the plasma-derived vaccine.

The effect of heating on the reactogenicity and the immunogenicity of a recombinant DNA hepatitis B vaccine was examined. Treatment of this vaccine for one week at 37 degrees C did not significantly alter these properties when compared to vaccine stored at 4 degrees C. These results have important implications in countries where facilities for the transport and handling of vaccines are often inadequate.