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Data standards are not only key to making data processing efficient but also fundamental to ensuring data interoperability. When clinical trial data are structured according to international standards, they become significantly easier to analyze, reducing the efforts required for data cleaning, preprocessing, and secondary use. A common language and a shared set of expectations facilitate interoperability between systems and devices. The main objectives of this study were to identify commonalities and differences in clinical trial metadata, protocols, and data collection systems/items within the VACCELERATE project. To assess the degree of interoperability achieved in the project and suggest methodological improvements, interoperable points were identified based on the core outcome areas-immunogenicity, safety, and efficacy (clinical/physiological). These points were emphasized in the development of the master protocol template and were manually compared in the following ways: (1) summaries, objectives, and end points in the protocols of 3 VACCELERATE clinical trials (EU-COVAT-1_AGED, EU-COVAT-2_BOOSTAVAC, and EU-COVPT-1_CoVacc) against the master protocol template; (2) metadata of all 3 clinical trials; and (3) evaluations from a questionnaire survey regarding differences in data management systems and structures that enabled data exchange within the VACCELERATE network. The noncommonalities identified in the protocols and metadata were attributed to differences in populations, variations in protocol design, and vaccination patterns. The detailed metadata released for all 3 vaccine trials were clearly structured using internal standards, terminology, and the general approach of Clinical Data Acquisition Standards Harmonisation (CDASH) for data collection (eg, on electronic case report forms). VACCELERATE benefited significantly from the selection of the Clinical Trials Centre Cologne as the sole data management provider. With system database development coordinated by a single individual and no need for coordination among different trial units, a high degree of uniformity was achieved automatically. The harmonized transfer of data to all sites, using well-established methods, enabled quick exchanges and provided a relatively secure means of data transfer. This study demonstrated that using master protocols can significantly enhance trial operational efficiency and data interoperability, provided that similar infrastructure and data management procedures are adopted across multiple trials. To further improve data interoperability and facilitate interpretation and analysis, shared data should be structured, described, formatted, and stored using widely recognized data and metadata standards. EudraCT 2021-004526-29; https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004526-29/DE/; 2021-004889-35; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004889-35; and 2021-004526-29; https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004526-29.

Although effective antiretroviral therapy(ART) increases CD4+ T-cell count, responses to ART vary considerably and only a minority of patients normalise their CD4+/CD8+ ratio. Although retention of naïve CD4+ T-cells is thought to predict better immune responses, relationships between CD4+ and CD8+ T-cell subsets and CD4+/CD8+ ratio have not been well described. A cross-sectional study in a cohort of ambulatory HIV+ patients. We used flow cytometry on fresh blood to determine expanded CD4+ and CD8+ T-cell subsets; CD45RO+CD62L+(central memory), CD45RO+CD62L-(effector memory) and CD45RO-CD62L+(naïve) alongside routine T-cell subsets(absolute, percentage CD4+ and CD8+ counts), HIVRNA and collected demographic and treatment data. Relationship between CD4+/CD8+ T-cell ratio and expanded T-cell subsets was determined using linear regression analysis. Results are median[IQR] and regression coefficients unless stated. We recruited 190 subjects, age 42(36-48) years, 65% male, 65.3% Caucasian, 91% on ART(52.6% on protease inhibitors), 78.4% with HIVRNA<40cps/ml and median ART duration 6.8(2.6-10.2) years. Nadir and current CD4+ counts were 200(112-309) and 465(335-607) cells/mm3 respectively. Median CD4+/CD8+ ratio was 0.6(0.4-1.0), with 26.3% of subjects achieving CD4+/CD8+ ratio>1. Of the expanded CD4+ T-cell subsets, 27.3(18.0-38.3)% were naïve, 36.8(29.0-40.0)% central memory and 27.4(20.0-38.5)% effector memory. Of the CD8+ T-cells subsets, 16.5(10.2-25.5)% were naïve, 19.9(12.7-26.6)% central memory and 41.0(31.8-52.5)% effector memory. In the multivariable adjusted analysis, total cumulative-ART exposure(+0.15,p = 0.007), higher nadir CD4+ count(+0.011,p<0.001) and higher %CD8+ naive T-cells(+0.0085,p<0.001) were associated with higher CD4+/CD8+ ratio, higher absolute CD8+ T-cell(-0.0044,p<0.001) and higher %CD4+ effector memory T-cells(-0.004,p = 0.0036) were associated with lower CD4+/CD8+ ratio. Those with CD4+/CD8+ ratio>1 had significantly higher median %CD8+ naive T-cells; 25.4(14.0-36.0)% versus 14.4(9.4-21.6)%, p<0.0001, but significantly lower absolute CD8+ count; 464(384.5-567) versus 765(603-1084) cells/mm3, p<0.001. Study suggests important role for naïve CD8+ T-cell populations in normalisation of the immune response to HIV-infection. How these findings relate to persistent immune activation on ART requires further study.

Increased prevalence of low bone mineral density (BMD) and increased fracture incidence are observed in persons living with HIV (PLWH). The trabecular bone score (TBS) is a novel index of bone microarchitecture which improves fracture prediction independent of BMD. The HIV UPBEAT study is a single centre, prospective cohort study that enrolled subjects with and without HIV from similar sociodemographic backgrounds for annual assessments of bone health. TBS was derived from lumbar spine (LS) dual-energy X-ray absorptiometry images. Univariate and multivariable linear regression was used to assess relationships between baseline TBS, BMD, sociodemographic and clinical factors. 463 subjects (201 HIV positive) were included; PLWH were younger and more likely male, of non-African ethnicity and current smokers. HIV was associated with a mean reduction of 0.037 [-0.060, -0.013] (p = 0.002) in TBS. Lower TBS was also associated with male gender, non-African ethnicity, current smoking status and lower LS BMD. HIV remained associated with lower TBS after adjustment for LS BMD, age, gender and ethnicity. However, adjustment for current smoking significantly attenuated the association between HIV and TBS, with further adjustment for higher bone turnover markers largely explaining any residual association. Among the sub-group of PLWH, exposure to protease inhibitors and lower nadir CD4+ T-cell counts were both predictors of lower TBS. PLWH have lower TBS independent of LS BMD. However, this is largely explained by higher current smoking rates and higher bone turnover in those with HIV. Exposure to PI, but not tenofovir disproxil fumarate, also contributed to lower TBS in those with HIV.

The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research. The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials. In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry. In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were \"positive\" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being \"very positive.\" Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries. Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies.

Television watching is obesogenic due to its sedentary nature and programming content, which influences children. Few studies have examined exercise placement within children-specific programming. This study aimed to investigate the frequency and type of exercise placement in children-specific television broadcasts and to compare placements on the UK and Irish television channels. Content analysis for five weekdays' worth of children-specific television broadcasting totaling 82.5 hours on both the UK (British Broadcasting Corporation) and Irish (Radió Teilifís Éireann) television channels was performed. For the purposes of comparing the UK and Irish placements, analysis was restricted to programming broadcast between 6 am and 11.30 am. Exercise placements were coded based on type of activity, activity context, activity motivating factors and outcome, and characters involved. A total of 780 cues were recorded during the total recording period. A wide variety of sports were depicted, but dancing-related cues were most commonly seen (n=163, 23.3%), with the majority of cues being of mild (n=365, 65.9%) or moderate (n=172, 31.0%) intensity. The majority of cues were associated with a positive outcome (n=404, 61.4%), and social motivations were most commonly seen (n=289, 30.3%). The Irish and the UK portrayals were broadly similar. This study highlights the wide variety of sports portrayed and the active effort undertaken by television stations to depict physical exercise and recreation in a positive light.

Background Overweight and obesity is a growing problem in Ireland. Many parents are unaware when their child is overweight or obese. Our objectives were to examine parents’ perceptions of a healthy diet and their children’s BMI; and to evaluate the food offered to children in our paediatric in-patient unit. Findings A retrospective questionnaire was distributed to 95 patients and their families admitted over one month. Seventy-eight had BMI values calculated (42 males, 36 females). Twenty-one children (26.9%) were overweight/obese: 14/21 parents (66.7%) thought their child had a normal weight. Sixty percent of children served dinner in the hospital were given fried potatoes. Four had fruit/vegetables. Forty-six parents brought food into hospital, of these 14 brought purchased food. Conclusions This study highlights the problem of child obesity in Ireland and parental underestimation of this problem. The nutritional value of food served to children in hospital needs to be improved and hospital admissions used as opportunities to promote healthy eating habits.

Objectives Increased time in which children spend watching television is a well-described contributor to paediatric obesity. This study investigated the frequency and type of food and beverage placement in children-specific television broadcasts and compared data from UK (UK) and Irish television stations. Design Content analysis, totalling 82.5 h, reflecting 5 weekdays of children-specific television broadcasting on UK and Irish television channels was performed. To allow comparison between UK and Irish food and beverage cues, only broadcasts between 06.00 and 11.30 were analysed. Data were coded separately by two analysts and transferred to SPSS for analyses. Food and beverage cues were coded based on type of product, product placement, product use, motivation, outcome and characters involved. Results A total of 1155 food and beverage cues were recorded. Sweet snacks were the most frequent food cue (13.3%), followed by sweets/candy (11.4%). Tea/coffee was the most frequent beverage cue (13.5%), followed by sugar-sweetened beverages (13.0%). The outcome of the cue was positive in 32.6%, negative in 19.8%, and neutral in 47.5% of cases. The most common motivating factor associated with each cue was celebratory/social (25.2%), followed by hunger/thirst (25.0%). Comparison of UK and Irish placements showed both to portray high levels of unhealthy food cues. However, placements for sugar-sweetened beverages were relatively low on both channels. Conclusions This study provides further evidence of the prominence of unhealthy foods in children's programming. These data may provide guidance for healthcare professionals, regulators and programme makers in planning for a healthier portrayal of food and beverage in children's television.

The link between childhood obesity and both television viewing and television advertising have previously been examined. We sought to investigate the frequency and type of food and beverage placements in children-specific television broadcasts and, in particular, differences between programme genres. Content of five weekdays of children-specific television broadcasting on both UK (BBC) and Irish (RTE) television channels was summarized. Food and beverage placements were coded based on type of product, product placement, product use and characters involved. A comparison was made between different programme genres: animated, cartoon, child-specific, film, quiz, tween and young persons' programming. A total of 1155 (BBC=450; RTE=705) cues were recorded giving a cue every 4·2 min, an average of 12·3 s/cue. The genre with most cues recorded was cartoon programming (30·8%). For the majority of genres, cues related to sweet snacks (range 1·8-23·3%) and sweets/candy (range 3·6-25·8%) featured highly. Fast-food (18·0%) and sugar-sweetened beverage (42·3%) cues were observed in a high proportion of tween programming. Celebratory/social motivation factors (range 10-40 %) were most common across all genres while there were low proportions of cues based on reward, punishment or health-related motivating factors. The study provides evidence for the prominence of energy-dense/nutrient-poor foods and beverages in children's programming. Of particular interest is the high prevalence of fast-food and sugar-sweetened beverage cues associated with tween programming. These results further emphasize the need for programme makers to provide a healthier image of foods and beverages in children's television.

Background The affliction of injecting drug use (IDU) has resulted in the emergence of a subgroup of people with a unique set of medical issues. We aimed to describe the emergency department (ED) presentations of IDUs. Methods In a prospective observational study over a 3-month period, we identified characteristics of patients with a history of active IDU presenting to the ED. Results From 1 January 2010 to 31 March 2010, 146 patients with a history of IDU were identified. These contributed to 222 acute presentations to the ED. Baseline characteristics revealed that patients were predominantly male, of Irish nationality, with high levels of homelessness, unemployment and lack of stable family or intimate partner relationships. 45% of presentations occurred as a result of infection (95% CI 38.5% to 51.5%). Trauma, pure toxicological issues, thromboembolic phenomena and psychiatric issues comprised the other common acute diagnoses. The burden of comorbid medical illness was substantial with high rates of hepatitis C infection (74%) and HIV infection (13.8%). Healthcare utilisation indices for this cohort are extreme on multiple measures. We found an ED attendance rate of 445 per 100 patient-years, an admission rate of 68.8 per 100 patient-years and mortality rate of 4.86 per 100 patient-years. Conclusions Our study characterises the emergency presentations of active IDUs. We describe considerable acute and chronic medical consequences and high healthcare utilisation associated with IDU. This study is of particular relevance to any institution that provides acute medical care to this group of patients.

Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey. From 15 eligible groups, those that were more frequently declared underserved/hard-to-reach in vaccine research were ethnic minorities (76.5%), persons experiencing homelessness (70.6%), illegal workers and refugees (64.7%, each). When prioritization for education on vaccine trials was considered, ethnic groups, migrants, and immigrants (5/17, 29.4%) were the groups most frequently identified by the NC as top targets. The most prominent barriers in vaccine trial participation affecting all groups were low levels of health literacy, reluctance to participate in trials due to engagement level, and low levels of trust in vaccines/vaccinations. This study highlighted population groups considered underserved/hard-to-reach in countries contained within the European region, and the respective barriers these groups face when participating in clinical studies. Our findings aid with the design of tailored interventions (within—and across—countries of the European region) and with the development of strategies to overcome major barriers in phase 2 and phase 3 vaccine trial participation.