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Psychopharmacological treatment is an important component of the multimodal intervention approach to treating mental health conditions in children and adolescents. Currently, there are many unmet needs but also opportunities, alongside possible risks to consider, regarding the pharmacological treatment of mental health conditions in children and adolescents. In this Position Paper, we highlight and address these unmet needs and opportunities, including the perspectives of clinicians and researchers from the European College of Neuropsychopharmacology–Child and Adolescent Network, alongside those of experts by lived experience from national and international associations, via a survey involving 644 participants from 13 countries, and of regulators, through representation from the European Medicines Agency. We present and discuss the evidence base for medications currently used for mental disorders in children and adolescents, medications in the pipeline, opportunities in the development of novel medications, crucial priorities for the conduct of future clinical studies, challenges and opportunities in terms of the regulatory and legislative framework, and innovations in the way research is conducted, reported, and promoted.

Many medicines are used “off-label” in children outside the terms of the license. Feasible pediatric clinical trials are a challenge to design. Conect4children (c4c) is an Innovative Medicines Initiative project to set up a pan-European pediatric clinical trial network aiming to facilitate the development of new medicines for children. To optimize pediatric trial development by promoting innovative trial design, c4c set up a European multidisciplinary advice service, including the voice of young patients and families, tailored to industry and academia. A network of experts was established to provide multidisciplinary advice to trial sponsors. Experts were selected to join clinical and innovative methodology expert groups. A patient and public involvement (PPI) database, to include the expert opinion of patients and parents/carers was formed. A stepwise process was developed: (1) sponsors contact c4c, (2) scoping interview takes place, (3) ad hoc advice group formed, (5) advice meeting held, and (6) advice report provided. Feedback on the process was collected. Twenty-four clinical and innovative methodology expert groups (>400 experts) and a PPI database of 135 registrants were established. As of September 30, 2022, 36 advice requests were received, with 25 requests completed. Clinical and methodology experts and PPI representatives participated in several advice requests. Sponsors appreciated the advice quality and the multidisciplinary experts from different countries, including experts not known before. Experts and PPI participants were generally satisfied with the process. The c4c project has shown successful proof of concept for a service that presents a new framework to plan innovative and feasible pediatric trials.

Patient understanding of complex surgical procedures and post-intervention consequences is often poor. Little is known about the effectiveness of 3D printed models to improve the comprehension of the medical information provided to patients. The purpose of this study was to determine if 3D printed patient-specific anatomical models could help improve patients’ satisfaction and understanding of complex oncological surgical procedures, their risks, benefits, and alternatives. Basic procedure A randomized, controlled crossover experiment was performed, where subjects were randomly assigned to different treatments of the study. This experiment involved teenage patients experts from Kids Barcelona, a Young Person's Advisory Group. The team (n = 14, age range 14–20, 9 females and 5 males) was divided into two groups involved in two simulated pre-surgical outpatient visits for complex oncologic surgical procedures: a high-risk stage 4 abdominal neuroblastoma, and a biliary tract rhabdomyosarcoma. Two senior oncologic surgeons participated in the study by performing the structured outpatient pre-surgical visit. Each participant received information before the study explaining the study methodology and was given a questionnaire. Main findings Data analysis of the group using the 3D printed model for the neuroblastoma case showed better results than without the 3D model. On the other hand, conversely, on the data analysis of the rhabdomyosarcoma case with the 3D printed model no better results were observed as compared to the case of not using a 3D model. However, the results of the participants’ knowledge were still better than before the intervention. Satisfaction was significantly better with a 3D model in both cases., Peer Reviewed, Objectius de Desenvolupament Sostenible::3 - Salut i Benestar, Postprint (published version)

Background: During the COVID-19 pandemic, lockdown strategies have been widely used to contain SARS-CoV-2 virus spread. Children and adolescents are especially vulnerable to suffering psychological effects as result of such measures. In Spain, children were enforced to a strict home lockdown for 42 days during the first wave. Here, we studied the effects of lockdown in children and adolescents through an online questionnaire. Methods: A cross-sectional study was conducted in Spain using an open online survey from July (after the lockdown resulting from the first pandemic wave) to November 2020 (second wave). We included families with children under 16 years-old living in Spain. Parents answered a survey regarding the lockdown effects on their children and were instructed to invite their children from 7 to 16 years-old (mandatory scholar age in Spain) to respond a specific set of questions. Answers were collected through an application programming interface system, and data analysis was performed using R. Results: We included 1,957 families who completed the questionnaires, covering a total of 3,347 children. The specific children’s questionnaire was completed by 167 kids (7–11 years-old), and 100 adolescents (12–16 years-old). Children, in general, showed high resilience and capability to adapt to new situations. Sleeping problems were reported in more than half of the children (54%) and adolescents (59%), and these were strongly associated with less time doing sports and spending more than 5 h per day using electronic devices. Parents perceived their children to gain weight (41%), be more irritable and anxious (63%) and sadder (46%). Parents and children differed significantly when evaluating children’s sleeping disturbances. Conclusions: Enforced lockdown measures and isolation can have a negative impact on children and adolescent’s mental health and well-being. In future waves of the current pandemic, or in the light of potential epidemics of new emerging infecti, Peer Reviewed, Postprint (published version)

Background: Rare disease communities are spread around the globe and segmented by their condition. Little research has been performed on the majority of rare diseases. Most patients who are affected by a rare disease have no research on their condition because of a lack of knowledge due to absence of common groups in the research community. // Objective: We aimed to develop a safe and secure community of rare disease patients, without geographic or language barriers, to promote research. Methods: Cocreation design methodology was applied to build Share4Rare, with consultation and input through workshops from a variety of stakeholders (patients, caregivers, clinicians, and researchers). // Results: The workshops allowed us to develop a layered version of the platform based on educating patients and caregivers with publicly accessible information, a secure community for the patients and caregivers, and a research section with the purpose of collecting patient information for analysis, which was the core and final value of the platform. // Conclusions: Rare disease research requires global collaboration in which patients and caregivers have key roles. Collective intelligence methods implemented in digital platforms reduce geographic and language boundaries and involve patients in a unique and universal project. Their contributions are essential to increase the amount of scientific knowledge that experts have on rare diseases. Share4Rare has been designed as a global platform to facilitate the donation of clinical information to foster research that matters to patients with rare conditions. The codesign methods with patients have been essential to create a patient-centric design., This work has been funded by the European Research Council under the European Union Horizon 2020 research and innovation program (grant agreement number H2020-780262-SHARE4RARE). BN acknowledges the support from Sant Joan de Déu Barcelona Children’s Hospital., Peer Reviewed, Postprint (published version)