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The products intended for professional use must guarantee the fulfilment of the safety and health requirements from the design phase; they are being tested in the experimentation and “zero series” stage to validate the series production. The work equipment for professional use, the industrial product prototype’s functional, operating and protection properties must be defined to establish the necessary conditions for their experimentation. In this sense, it is necessary to develop specific tools for the management of professional risks in order to take the decision at the managerial level to protect the workers who carry out industrial activities. The study presents research results regarding establishing security and compliance conditions to develop a methodology for experimentation, testing and validation of product prototypes intended to protect workers and prevent occupational risks in electrical installations. As part of the research study, a managerial tool for managing professional risks was developed in order to ensure the protection of people who carry out industrial activities and the prevention of occupational risks in the energy sector, which consisted of an intelligent decision support tool necessary for designing, experimenting the product prototype, the testing of the upgraded product model and its validation, to introduce it into series production.

Implementing the objectives set at the European and national level to minimize dependence on fossil fuels and mitigate the impact of transport on the environment by introducing fiscal facilities has led to an increase in the market for electric vehicles. This increase requires the development and expansion of charging infrastructure for electric vehicles. The transition from the supply of classic fuel vehicles to the electric ones led to the elimination of some risks and the appearance of new risks for the charging stations’ maintenance staff and the users. The study presents research on the identification of technical and safety requirements specific to a category of work equipment used to charge electric vehicles - charging stations. The technical and safety requirements applicable to electric vehicle charging stations have the role of providing the criteria underlying the management of the necessary risk management of both manufacturers and users and entities that ensure the maintenance of this equipment to adopt highly technical solutions.

Work equipment must provide compliance with the essential safety and health requirements applicable from the design and manufacturing stage to ensure a high level of protection of social interests, safety and health at work, and environmental protection. Non-conformities are discovered during the initial commissioning of work equipment in some circumstances due to incorrect design and/or manufacture, resulting in unsafe and non-compliant equipment that is defective when placed on the market and marketed. The purpose of this article is to present the research findings. The goal was to assess the risks associated with the security aspects of digital paper and cardboard printing machinery, to ensure compliance with current safety and health regulations, and to limit the risk of operating defective products. The study offered research results on the establishment of safety and compliance conditions, in order to design a methodology for assessment and technical inspection of work equipment, based on risk assessment and taking into account the usual and anticipated use of the work equipment. Introduction on the market, to improve the efficiency of technical inspection and market surveillance operations by detecting and generating risk profiles for work equipment manufacturer non-conformity.

Occupational risk assessment is a prevention tool used to manage safety and health at work in the national economy sectors of activity. Within the operation and maintenance in underground electrical installations, several major risk factors are identified, mainly due to work equipment cumulated with risk factors generated by the work environment and workload. To highlight the working conditions and the technical requirements of the underground electrical installations, the activity carried out for 50 years was analyzed, taking into account the lifespan of the electrical installations. Also, the events and accidents at work, the assessments of the risk in the workplace was analysed and represents a synthesis of research studies carried out so far. The research highlights the role of safety measures aimed to ensure the safety and health of workers working in underground electrical installations, mainly about work equipment and the means of work against electrocution to efficiently manage occupational risks and reduce workplace accidents and occupational disease, as well as technical events in electrical installations.

Transformative changes in the health of children with cystic fibrosis (CF) mean that more sensitive outcome measures are needed to monitor paediatric CF lung disease. Multiple breath washout (MBW) and its primary readout lung clearance index are gaining increasing traction as an endpoint for clinical trials in the CF space and show promise as a clinical investigation. In this article, we use four clinically based questions to explore what MBW can and cannot (yet) do and highlight some of its strengths and weaknesses as an investigation. We end by discussing how we can increase the utility of MBW as an investigation in children with CF., Competing Interests: Competing interests: RD has accepted honoraria from Vertex Pharmaceuticals and Chiesi and has been awarded grants from the Cystic Fibrosis Trust. JCD has undertaken clinical trial leadership and/ or Advisory Board and speaking roles for Vertex Pharmaceuticals, Boehringer-Ingelheim, Eloxx, Algipharma, Abbvie, Arcturus, Enterprise Therapeutics, Recode, LifeArc, Genentech, and Tavanta. She has been awarded research grants from the UK Cystic Fibrosis Trust, Cystic Fibrosis Foundation, Cystic Fibrosis Ireland, EPSRC, NIHR and LifeArc., (© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Cystic fibrosis (CF) is traditionally associated with considerable and progressive multisystem pathology, onerous treatment burden, complex psychosocial challenges, and reduced life-expectancy [1-9].This decade has seen transformative change in management for many, but not all, people with CF. The most notable change comes from Cystic Fibrosis Transmembrane Receptor (CFTR) modulators, which bring significant benefits for people who are eligible for, and able to access, them [10]. However alongside, or perhaps because of, this exciting progress, the past few years have also brought important novel challenges to the psychosocial wellbeing of people with CF. This article, written as a collaboration between CF psychologists, social workers, physicians and nurses aims to provide an accessible overview of the novel psychosocial challenges now faced by children, their families, and adults with CF, and to invite consideration of their changing psychosocial requirements to inform future holistic care. Themes include geopolitical stressors such as the pandemic and its wake, a growing divide between those able or unable to access CFTR modulators, potential rapid changes in life expectancy secondary to these drugs and the inevitable associated challenges this brings; evolving body image, mental health side effects of CFTR modulators, the challenges of adherence in apparently well children and young adults, as well as the diagnostic conundrum and associated anxiety of the cystic fibrosis screen positive inconclusive diagnosis (CFSPID) label. It also highlights some unmet research and service delivery needs in the area., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SC, FD, AD, AE, MP, SM have no conflicts to declare. RD is supported by a clinical lectureship from the National Institute of Health Research. She has received honorariums from Vertex for contributing to educational meetings. She has received travel reimbursement from Vertex, Chiesi, ProQR, The British Thoracic Society and The British Lung Foundation for attendance at meetings and conferences. She holds grants from The Cystic Fibrosis Trust and the CF Foundation. JCD has undertaken clinical trial leadership and/ or Advisory Board and speaking roles for Vertex Pharmaceuticals, Boehringer-Ingelheim, Eloxx, Algipharma, Abbvie, Arcturus, Enterprise Therapeutics, Recode, LifeArc, Genentech, and Tavanta. She has been awarded research grants from the UK Cystic Fibrosis Trust, Cystic Fibrosis Foundation, Cystic Fibrosis Ireland, EPSRC, NIHR and LifeArc. AMGreports personal fees from the Belgian Cystic Fibrosis Foundation/King Baudouin Foundation; grants, personal fees and travel reimbursement from the Cystic Fibrosis Foundation, grants from the Dutch Cystic Fibrosis Foundation; travel reimbursement from the European Cystic Fibrosis Society; travel reimbursement from the French Cystic Fibrosis Society; personal fees from the Italian Cystic Fibrosis Research Foundation; grant funding from the National Heart, Lung and Blood Institute, grants and personal fees from; and personal fees from Virginia Commonwealth University. RMC has received honorariums from Vertex and Chiesi for contributing to educational meetings. PM has received research grants from Vertex Pharmaceuticals, CF Trust, CFF and CF Ireland. He has received speakers’ fees and participated in advisory boards with Vertex pharmaceuticals., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Cystic fibrosis (CF) is a multisystem, genetic disease with a significantly reduced life expectancy. Despite substantial progress in therapies in the last 10-15 years, there is still no cure. There are dozens of drugs in the development pipeline and multiple clinical trials are being conducted across the globe. The UK Cystic Fibrosis Trust's (CFT) Clinical Trials Accelerator Platform (CTAP) is a national initiative bringing together 25 UK based CF centres to support the CF community in accessing and participating in CF clinical trials. CTAP enables more CF centres to run a broader portfolio of trials and increases the range of CF studies available for UK patients. There are four large specialist CF centres based in London, all within a small geographical region as well as two smaller centres which deliver CF care. At the launch of CTAP, these centres formed a sub-network in a consortium-style collaboration. The purpose of the network was to ensure equity of access to trials for patients across the UK's capital, and to share experience and knowledge. Four years into the programme we have reviewed our practices through working group meetings and an online survey. We sought to identify strengths and areas for improvement. We share our findings here, as we believe they are relevant to others delivering research in regions outside of London and in other chronic diseases., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Professor Jane Davies has undertaken clinical trial leadership and/or Advisory Board and speaking roles for Vertex Pharmaceuticals, Boehringer-Ingelheim, Eloxx, Algipharma, Abbvie, Arcturus, Enterprise Therapeutics, Recode, LifeArc, Genentech, and Tavanta. She has been awarded research grants from the UK Cystic Fibrosis Trust, Cystic Fibrosis Foundation, Cystic Fibrosis Ireland, EPSRC, NIHR and LifeArc., (© 2024 Published by Elsevier Inc.)

Background: Patient-centred trial design optimises recruitment and retention, reduces trial failure rates and increases the diversity of trial cohorts. This allows safe and effective treatments to reach clinic more quickly. To achieve this, patients' views must be incorporated into trial design., Methods: A discrete choice experiment was used to quantify preferences of pwCF for trials features; medicine type, trial location, stipend, washout, drug access on trial completion and trial design. Respondents were presented pairs of hypothetical trial scenarios with different level combinations assigned through experimental design. Respondents were asked to pick their preferred option or decline both. The cross-sectional data were explored using a Random Parameters Logit model., Results: We received 207 eligible responses between Oct2020-Jan2021. The strongest influence on the decision to participate was trial location; pwCF favour participation at their usual clinical centre. Greater travel distances made respondents less willing to participate. Post-trial drug access ranked second. pwCF would rather participate in modulator trials than trials of other drugs. In general, pwCF did not favour a washout period, but were more prepared to washout non-modulators than modulators. Stipend provision was not ranked highly, but higher stipends increased intention to participate. Trial design (placebo vs open-label) had minimal influence on the decision to participate. There are complex interactions between placebos and washouts., Conclusions: We used quantitative methods to systematically elicit preferences of pwCF for clinical trials' features. We explore the relevance of our findings to trial design and delivery in the current CF trials landscape., Competing Interests: Declaration of Competing Interest JCD has performed clinical trial leadership roles, educational and/ or advisory activities for the following: Abbvie, Algipharma AS, Bayer AG, Boehringer Ingelheim Pharma GmbH & Co. KG, Eloxx, Enterprise, Galapagos NV, Genentech, ImevaX GmbH, Ionis, LifeArc, Nivalis Therapeutics, Inc., Krystal Biotech, Novartis, PARI Medical Holding GmbH, ProQR Therapeutics III B.V., Proteostasis Therapeutics INC., Pulmocide, Raptor Pharmaceuticals Inc, Recode, Vertex Pharmaceuticals. JSE has provided consultancy and advice for Vertex, Celtaxsys, Corbus, Ionis in clinical trial design and delivery. He also holds an EU Innovative medicines Initiative grant with Novartis, Polyphor and Alaxia. MB, RD, FK and SM have no conflicts to declare., (Copyright © 2023. Published by Elsevier B.V.)

Understanding the number of patients eligible to participate in research is important to design protocols and define research priorities. We reviewed the records of all patients with CF, age 12+, who receive care at our centre. We assessed their eligibility for trial participation based on common trial inclusion/exclusion criteria. 643 patients were included in the analysis, 31 were modulator ineligible(MI). Only 198(31 %) of the total cohort and 7(23 %) of the MI cohort were eligible for participation based on the hypothetical criteria. The most common reason for ineligibility was ppFEV1 ≥90 % followed by clinical instability, complex comorbidity and anticipated inability to adhere to the protocol. We suggest this would be a useful exercise for centres planning to either participate in, or refer subjects into, upcoming trials to undertake for their own cohort. We also make suggestions for protocol designs that optimise the number of patients who are eligible to participate., Competing Interests: Declaration of Competing Interest RD, SP, AJ and SM have no conflicts to declare. NJS has received fees for consultancy and speaking from Vertex, Chiesi, Gilead, Roche, Teva, Zambon, and Pulmocide. JCD has performed clinical trial leadership roles, educational and/ or advisory activities for the following: Abbvie, Algipharma AS, Bayer AG, Boehringer Ingelheim Pharma GmbH & Co. KG, Eloxx, Enterprise, Galapagos NV, Genentech, ImevaX GmbH, Ionis, LifeArc, Nivalis Therapeutics, Inc., Krystal Biotech, Novartis, PARI Medical Holding GmbH, ProQR Therapeutics III B.V., Proteostasis Therapeutics INC., Pulmocide, Raptor Pharmaceuticals Inc, Recode, Vertex Pharmaceuticals., (Copyright © 2023. Published by Elsevier B.V.)

Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2023 The Author(s).)

This is an exciting time for research and novel drug development in cystic fibrosis. However, rarely has the adage, "Children are not just little adults" been more relevant. This article is divided into two main sections. In the first, we explore why it is important to involve children in research. We discuss the potential benefits of understanding a disease and its treatment in children, and we highlight that children have the same legal and ethical right to evidence-based therapy as adults. Additionally, we discuss why extrapolation from adults may be inappropriate, for example, medication pharmacokinetics may be different in children, and there may be unpredictable adverse effects. In the second part, we discuss how to involve children and their families in research. We outline the importance and the complexities of selecting appropriate outcome measures, and we discuss the role co-design may have in improving the involvement of children. We highlight the importance of appropriate staffing and resourcing, and we outline some of the common challenges and possible solutions, including practical tips on obtaining consent/assent in children and adolescents. We conclude that it is unethical to simply rely on extrapolation from adult studies because research in young children is challenging and that research should be seen as a normal part of the paediatric therapeutic journey.

Since the discovery of the gene responsible for cystic fibrosis (CF) in 1989, hopes have been pinned on a future with novel therapies tackling the basis of the disease rather than its symptoms. These have become a reality over the last decade with the development through to the clinic of CF transmembrane conductance regulator (CFTR) modulators. These are oral drugs which improve CFTR protein function through either increasing the time the channel pore is open (potentiators) or facilitating its trafficking through the cell to its location on the cell membrane (correctors). The first potentiator, ivacaftor, is now licensed and available clinically in many parts of the world. It is highly effective with impressive clinical impact in the lungs and gastrointestinal tract; longer-term data from patient registries show fewer exacerbations, a slower rate of lung function loss and reduced need for transplantation in patients receiving ivacaftor. However, as a single drug, it is suitable for only a small minority of patients. The commonest CFTR mutation, F508del, requires both correction and potentiation for clinical efficacy. Two dual-agent drugs (lumacaftor/ivacaftor and tezacaftor/ivacaftor) have progressed through to licensing, although their short term impact is more modest than that of ivacaftor; this is likely due to only partial correction of protein misfolding and trafficking. Most recently, triple compounds have been developed: two different corrector molecules (elexacaftor and tezacaftor) which, by addressing different regions in the misfolded F508del protein, more effectively improve trafficking. In addition to large improvements in clinical outcomes in people with two copies of F508del, the combination is sufficiently effective that it works in patients with only one copy of F508del and a second, nonmodulator responsive mutation. For the first time, we thus have a drug suitable for around 85% of people with CF. Even more gains are likely to be possible when these drugs can be used in younger children, although more sensitive outcome measures are needed for this age group. Special consideration is needed for people with very rare mutations; those with nonmodulatable mutation combinations will likely require gene or messenger RNA-based therapeutic approaches, many of which are being explored. Although this progress is hugely to be celebrated, we still have more work to do. The international collaboration between trials networks, pharma, patient organizations, registries, and people with CF is something we are all rightly proud of, but innovative trial design and implementation will be needed if we are to continue to build on this progress and further develop drugs for people with CF., (© 2020 The Authors. Pediatric Pulmonology Published by Wiley Periodicals LLC.)