Virtual Reality as a Hypnotic Tool in the Management of Anxiety During the Performance of the Axillary Block.

Regional anaesthesia is a gold standard in upper limb orthopaedic surgery. Carried out on an awake patient, it can be a source of anxiety. In recent years, hypnotic techniques have been proposed in the management of perioperative anxiety. Among them, virtual reality is increasingly used as a distraction tool during anxious or painful actions despite the scarcity of proof of its benefit in the literature. Before implementing the systematic use of virtual reality when performing regional anaesthesia in our institution, we designed a study hypothesizing that the use of a virtual reality headset when performing an axillary block would reduce patient's anxiety. The study is an investigator-initiated, prospective monocentric and observational trial comparing anxiety scores of patients who underwent upper limb surgery under an axillary block with or without virtual reality headset. The perioperative anxiety was assessed by a numerical range scale before and after the peripheral nerve block performance. Between June 2021 and June 2022, 99 patients were included: 53 wearing the virtual reality headset and 46 not. The difference in numerical range scale for anxiety before and after the axillary block performance did not differ in the virtual reality group compared to the group without headset (mean = -1.9 ± 2.5 vs -1.5 ± 2.0, (p = 0.2520)). Technical difficulties reported by the operators were similar in both groups. Despite the large number of patients included, the virtual reality headset did not reduce patient's anxiety during a peripheral nerve block. Perioperative anxiety was low in all patients.

Elexacaftor/tezacaftor/ivacaftor-real-world clinical effectiveness and safety. A single-center Portuguese study.

OBJECTIVE: To evaluate the effectiveness of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) and to characterize its safety profile in cystic fibrosis (CF) patients in a real-world clinical setting. METHODS: This was a prospective observational study carried out in a CF referral center in Portugal involving adult CF patients who started treatment with ELX/TEZ/IVA. Clinical characteristics of the patients were collected, and effectiveness and safety data were evaluated. RESULTS: Of the 56 patients followed in the center at the time of the study, 28 were eligible for ELX/TEZ/IVA treatment in accordance with the Portuguese National Authority for Medicines and Health Products at the time of the study. Of these, 24 met the follow-up time requirement to be included in the clinical effectiveness analysis. The mean follow-up time was 167.3 ± 96.4 days. Adverse events were generally mild and self-limited. Significant improvements in lung function, BMI, sweat chloride concentration, and number of pulmonary exacerbations were observed. No significant differences in outcomes between F508del homozygous and heterozygous patients were found. The effectiveness of this new CFTR modulator combination also applied to patients with advanced lung disease. CONCLUSIONS: Treatment with ELX/TEZ/IVA showed effective improvement in real-world clinical practice, namely in lung function, BMI, sweat chloride concentration, and number of pulmonary exacerbations, with no safety concerns.

Elexacaftor/tezacaftor/ivacaftor-real-world clinical effectiveness and safety. A single-center Portuguese study / Elexacaftor/tezacaftor/ivacaftor-efetividade clínica e segurança no mundo real. Estudo unicêntrico português

ABSTRACT Objective: To evaluate the effectiveness of treatment with elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) and to characterize its safety profile in cystic fibrosis (CF) patients in a real-world clinical setting. Methods: This was a prospective observational study carried out in a CF referral center in Portugal involving adult CF patients who started treatment with ELX/TEZ/IVA. Clinical characteristics of the patients were collected, and effectiveness and safety data were evaluated. Results: Of the 56 patients followed in the center at the time of the study, 28 were eligible for ELX/TEZ/IVA treatment in accordance with the Portuguese National Authority for Medicines and Health Products at the time of the study. Of these, 24 met the follow-up time requirement to be included in the clinical effectiveness analysis. The mean follow-up time was 167.3 ± 96.4 days. Adverse events were generally mild and self-limited. Significant improvements in lung function, BMI, sweat chloride concentration, and number of pulmonary exacerbations were observed. No significant differences in outcomes between F508del homozygous and heterozygous patients were found. The effectiveness of this new CFTR modulator combination also applied to patients with advanced lung disease. Conclusions: Treatment with ELX/TEZ/IVA showed effective improvement in real-world clinical practice, namely in lung function, BMI, sweat chloride concentration, and number of pulmonary exacerbations, with no safety concerns.

RESUMO Objetivo: Avaliar a efetividade do tratamento com elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) e caracterizar seu perfil de segurança em pacientes com fibrose cística (FC) em um cenário clínico de mundo real. Métodos: Estudo observacional prospectivo realizado em um centro de referência em FC de Portugal com pacientes adultos com FC que iniciaram o tratamento com ELX/TEZ/IVA. As características clínicas dos pacientes foram coletadas, e os dados de efetividade e segurança, avaliados. Resultados: Dos 56 pacientes acompanhados no centro na época do estudo, 28 eram elegíveis para o tratamento com ELX/TEZ/IVA de acordo com a Autoridade Nacional do Medicamento e Produtos de Saúde. Destes, 24 atenderam ao requisito de tempo de acompanhamento para inclusão na análise de efetividade clínica. O tempo médio de acompanhamento foi de 167,3 ± 96,4 dias. Os eventos adversos foram geralmente leves e autolimitados. Foram observadas melhoras significativas na função pulmonar, no IMC, na concentração de cloreto no suor e no número de exacerbações pulmonares. Não foram encontradas diferenças significativas nos resultados entre os pacientes homozigotos e heterozigotos para F508del. A efetividade dessa nova combinação de moduladores da CFRT em fibrose cística também se aplica a pacientes com doença pulmonar avançada. Conclusões: O tratamento com ELX/TEZ/IVA demonstrou melhora efetiva na prática clínica real, a saber, na função pulmonar, no IMC, na concentração de cloreto no suor e no número de exacerbações pulmonares, sem preocupações de segurança.

Estudos longitudinal do desenvolvimento de recém-nascidos pré-termo: avaliaçäo na idade pré-escolar / Follow-up study of the development of preterm neonates: assessment at preschool age

Apesar das evidências de distúrvios de aprendizagem e atraso no desenvolvimento neuropsicomotor em crianças com história de prematuridade, existem poucos programas estruturados de acompanhamento longitudinal de recém-nascidos de alto risco no país, sendo pobre a documentaçäo sobre o desenvolvimento dessas crianças em nosso meio. O objetivo deste estudo foi avaliar aspectos do desenvolvimento perceptual e motor, do comportamento e do desenpenho escolar em um grupo de 22 crianças pré-escolar, participaram de um programa de acompanhamento do desenvolvimento de recém-nascidos de alto risco. Os pais foram entrevistados e as crianças submetidas a testes apropriados para detecçäo de distúrbios leves no desenvolvimento neuropsicomotor. Os dados foram analisados de maneira descritiva e os resultados indicam que, das 22 crianças examinadas, 8 (37 por cento) apresentram desenvolvimento normal e 14 (63 por cento apresentaram desenpenho inconsistente ou nitidamente abaixo do esperado para a idade nos testes perceptuais, motores e em expectativas de desenpenho escolar. Os resultados resaltam a importância de programas de acompanhamento longitudinal de recém-nascidos pré-termo, sendo também discutida a relevância de fatores de risco biológico e aspecto da validade preditiva de instrumentos utilizados para detecçäo precoce de distúrbios do desenvolvimento em crianças de risco