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Hoy — Diciembre 16th 2025Tus fuentes RSS

Is a change in mouth opening associated with improvements in quality of life in children with type 1 obstructive sleep apnoea after adenotonsillectomy? Protocol for the JawChild prospective cohort study

Por: Akkari · M. · Lopez · R. · Jaussent · I. · Vidal · C. · Skinner · S. · Jaffuel · D. · Molinari · N.
Introduction

Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

Methods and analysis

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3–7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

Ethics and dissemination

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

Trial registration number

NCT06973928.

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Robot-assisted versus standard laparoscopic approach of total hysterectomy for deep infiltrating endometriosis and adenomyosis (ENDORAS TRIAL): study protocol for a randomised controlled trial

Por: Renso · M. · Bendifallah · S. · Estrade · J.-P. · Merlot · B. · Roman · H. · Vidal · F. · Collinet · P.
Introduction

Endometriosis affects 5–10% of women during reproductive years, with a 20–30% incidence among those with infertility. Deep infiltrating endometriosis (DIE) affects 10–15% of women of childbearing age and 50% of infertile women. When hormonal therapy and conservative surgery prove ineffective, total hysterectomy with or without bilateral salpingo-oophorectomy may be the ultimate therapeutic option. Laparoscopic surgery is the gold standard for treating endometriosis, offering effective disease eradication, safety, reduced pain, shorter hospital stay and faster recovery compared with laparotomy. However, patients undergoing total laparoscopic hysterectomy with DIE have higher risks of complications and organ damage, particularly urinary tract damage. Robot-assisted laparoscopic hysterectomy has emerged as a promising alternative, with a significantly lower conversion rate than total laparoscopic hysterectomy in patients with endometriosis. This study evaluates the safety and efficacy of robot-assisted total laparoscopic hysterectomy (RATLH) versus total laparoscopic hysterectomy (TLH) in the management of DIE. We hypothesise that robot-assisted laparoscopic hysterectomy will result in fewer complications and better outcomes compared with total laparoscopic hysterectomy in DIE patients.

Methods and analysis

The ENDORAS trial is a prospective, multicentre, open-label, randomised controlled trial conducted in French reference hospitals specialising in endometriosis surgery. A total of 224 adult women patients will be enrolled in this study if they have DIE with adenomyosis, and without digestive tract involvement as confirmed by MRI. Participants will be randomised to undergo either RATLH or TLH. The primary outcome will be the intraoperative and postoperative complication rates, classified according to the Clavien-Dindo classification (grade 2 or above) at the 3-month postoperative follow-up. Among the secondary outcomes, we will evaluate the quality of life using various questionnaires, including the Endometriosis Health Profile-30, the Short Form-306 and the Female Sexual Function Index.

Ethics and dissemination

The ENDORAS trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practice guidelines. All trial documents and procedures have been reviewed and approved by the Ethics Committee Ile de France II (approval ID number: 24.01408.000300). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.

Trial registration number

NCT06445179. Registered on 14 November 2024.

A Comprehensive Assessment of the Environmental Impact of Different Infant Feeding Types: The Observational Study GREEN MOTHER

ABSTRACT

Aim(s)

To observe and compare the environmental impacts of different types of infant feeding, considering the use of formula, infant feeding accessories, potentially increased maternal dietary intake during breastfeeding (BF) and food consumption habits.

Design

An observational cross-sectional multicentre study conducted in the Barcelona Metropolitan Area of the Catalan Institute of Health.

Methods

Data were collected from 419 postpartum women on infant feeding type (formula milk and accessories), maternal dietary intake (24-h register) and food consumption habits from November 2022 to April 2023. The environmental impacts (climate change (CC), water consumption and water scarcity) of the infant feeding types and maternal diet were calculated using the IPCC, ReCiPE and AWARE indicators, respectively. The differences in impacts were calculated by Kruskal–Wallis test.

Results

Significant differences for the three environmental impacts were observed. The CC impact of formula milk and feeding accessories was 0.01 kg CO2eq for exclusive BF, 1.55 kg CO2eq for mixed feeding and 4.98 kg CO2eq for formula feeding. While BF mothers consumed an extra 238 kcal, no significant differences were found related to maternal diet across feeding types.

Conclusion

Exclusive BF was the most sustainable type of infant feeding, considering formula and infant feeding accessories. In our study, the difference between the impacts of BF and non-BF mothers' diet was insignificant.

Implications for the Profession and/or Patient Care

Offer informative and educational support for midwives and other healthcare professionals on BF and a healthy, sustainable diet to transfer this knowledge to the general public.

Impact

Raise the general public's awareness about BF and a healthy, sustainable diet. To reduce environmental impacts through behavioural changes.

Reporting Method

STROBE.

Patient or Public Contribution

Patients of the Catalan Health Service reviewed the content of the data collection tools.

Trial Registration: (for the whole GREEN MOTHER project): NCT05729581 (https://clinicaltrials.gov)

Validation and selection of criteria for evaluating apps for managing depression: a Delphi study

Por: Robles · N. · Fuster-Casanovas · A. · Moreto · S. · Duarte-Diaz · A. · Gelabert · E. · Padilla-Ruiz · M. · Gomez · C. · Perez-Navarro · A. · Vidal-Alaball · J. · Subira · S. · Davins · M. · Saigi-Rubio · F. · Carrion · C.
Background

Despite a lack of evidence relating to effectiveness and safety, the use of apps in the field of mental health is increasing due to their ease of use and accessibility. The aim of the EvalDepApps project is to develop and validate an assessment tool for evaluating depression management apps based on scientific evidence, expert judgement and end-user needs.

Objective

The purpose of this study was to determine the most relevant criteria for evaluating apps intended to manage depression through consensus-based assessment.

Methods

A total of 43 individuals were invited to participate in an online modified Delphi study of 51 criteria identified from the literature. In Round 1, participants rated criteria according to relevance and three levels of consensus were defined: high level when ≥80% of respondents scored the criterion at 5 or 6; medium when 60%–79% of respondents scored the criterion at 5 or 6 and low when

Findings

The response rate was 59.0% (26/43) in Round 1 and 53.4% (23/43) in Round 2. In Round 1, 24 criteria (47.1%) attained the maximum level of consensus, 20 (39.2%) the medium level and 7 (13.7%) the lowest level. In Round 2, 4 out of 20 criteria (20.0%) attained the maximum consensus. Participant comments reinforced the relevance of the selected criteria. The final list consisted of 28 criteria, the majority relating to Safety and Privacy and Clinical Effectiveness (25.0% each), followed by Usability and Functionality (17.9%).

Conclusions

By prioritising criteria relating to data safety and clinical effectiveness, participants in this study emphasised that the assessment of apps for depression management must take both these aspects into full consideration. Despite some limitations of the study (eg, lack of participant sociodemographic data and its implications for generalisation, not face-to-face inter-round), the results of this study will enable the EvalDepApps project to develop an assessment tool for depression management apps that incorporates the most relevant criteria.

Clinical implications

EvalDepApps will support healthcare professionals and users in identifying safe, effective and user-friendly depression management apps.

Co-creating and testing a self-management digital solution for bladder health and urinary continence among people aged 50 and over: protocol for the international KOKU Bladder project

Por: Jerez-Roig · J. · Aguila-Gimeno · O. · Brazaitis · M. · Solianik · R. · Karkauskiene · E. · Jarutiene · L. · Fuente-Vidal · A. · Borralleras-Fumana · E. · Gasteiger · N. · Stanmore · E.
Introduction

The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.

Methods and analysis

Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.

Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.

Ethics and dissemination

The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.

Trial registration number

NCT06583733.

PROSPERO registration number

CRD42024597624.

Impact of increased resident preparation time on internal medicine rounds in a tertiary teaching hospital: a time-motion study with a before-and-after comparison

Por: Garnier · A. · Cominetti · F. · Monti · M. · Marques-Vidal · P. · Bastardot · F. · Vollenweider · P. · Waeber · G. · Castioni · J. · Gachoud · D. · Kraege · V.
Objectives

To determine whether postponing daily medical rounds to provide additional preparation time for residents reduces round duration and alters time allocation during rounds, with the hypothesis that increased preparation leads to more efficient rounds without reducing patient contact.

Design

Time and motion study with a before-and-after comparison.

Setting

Internal medicine division of Lausanne University Hospital, a Swiss tertiary teaching hospital.

Participants

75 residents; 60% women; mean age of 29.6 years and 3.0 years of training.

Intervention

In 2017, the daily work schedule was reorganised by postponing rounds from 09:00 to 10:00 and moving educational sessions to the afternoon, thereby freeing 90 min to prepare patient cases before rounds.

Primary and secondary outcome measures

The primary outcome was the duration of rounds and the proportion thereof spent with patients, using computer systems or in discussion with colleagues. Secondary outcomes included the detailed distribution of resident activities during the officially scheduled round period, particularly time dedicated to supervision, teaching and administrative tasks.

Results

Round duration decreased from 142 min per shift (95% CI 128 to 156) in 2015 to 112 min (95% CI 101 to 124) in 2018 (p=0.001). The proportion of round time spent directly with patients remained stable at 47%. Computer use during rounds decreased from 43% to 32% (p

Conclusions

Postponing rounds to allow more preparation time was associated with shorter, possibly more efficient rounds, reduced computer use in patient presence and increased supervision and teaching.

Trial registration number

ISRCTN69703381, https://doi.org/10.1186/ISRCTN69703381 (registration date: 24 April 2018).

El cuidado al final de la vida en la reforma de la Enfermería de San Juan de Dios

Introducción: La reforma de la Enfermería promovida por San Juan de Dios en el Renacimiento español transformó los cuidados al final de la vida, sentando las bases para la atención actual. Frente a la concepción medieval de la muerte, centrada en el juicio ultraterreno y los rituales eclesiásticos, la perspectiva humanista otorgó protagonismo al moribundo y a su acompañamiento espiritual y corporal, configurando un modelo que reconoce la dignidad humana y la reconciliación personal. Objetivo: Analizar las contribuciones de San Juan de Dios en los cuidados durante la agonía y post-mortem, evidenciando su impacto en la evolución de la práctica enfermera y su legado en los cuidados paliativos contemporáneos. Metodología: Se realizó un análisis historiográfico apoyado en la historia de las mentalidades y el método biográfico moderno, utilizando fuentes primarias (cartas y procesos de beatificación) y secundarias (biografías). La categorización documental incluyó los cuidados en la agonía y post-mortem, triangulando los resultados con estudios históricos previos. Análisis documental: Los hallazgos revelan que San Juan de Dios promovió prácticas innovadoras en su época, como el acompañamiento personalizado, la reconciliación espiritual, y la atención a las necesidades materiales y emocionales de los moribundos. Instituyó recursos como testamentos, mediaciones de perdón, y un modelo hospitalario basado en la dignidad y el consuelo espiritual. Además, sus rituales post-mortem fomentaron la cohesión comunitaria y el respeto hacia los fallecidos. Conclusiones: San Juan de Dios reconfiguró el cuidado al final de la vida, integrando elementos humanistas y espirituales que trascendieron su contexto histórico. Este legado sigue vigente en la práctica enfermera moderna, resaltando la importancia de los cuidados integrales, la preparación para la muerte y la continuidad de la memoria tras el fallecimiento.

Recommendations for the use of biomarkers for the management of adults with sepsis: a scoping review and critical appraisal

Por: Mateos-Haro · M. · Garcia-Santa-Vinuela · A. · Molano-Franco · D. · Sola · I. · Gordo-Vidal · F. · Martin-Delgado · M. C. · Lopez-Alcalde · J. · Zamora · J.
Objective

A synthesis and appraisal of the recommendations for biomarkers in practice guidelines concerning sepsis is required to consolidate evidence-based practice. We generated an evidence gap map (EGM) on the use of biomarkers for managing adults with sepsis.

Design

Scoping review.

Data sources

MEDLINE, Guidelines International Network, Pan American Health Organization, Trip Database and UpToDate were searched from 2016 to March 2025.

Eligibility criteria

Guidance documents (GD) that searched at least one literature source and provided clinical recommendations for the use of biomarkers for the management (diagnosis and prognosis, including treatment response) of adults with sepsis.

Data extraction and synthesis

Two reviewers independently applied the eligibility criteria and extracted data. We used the AGREE-II (Appraisal of Guidelines for Research and Evaluation) tool to assess the GD quality. GDs that scored ≥50% on the AGREE-II 'Rigour of development' domain were considered robust. We also applied the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system to evaluate if the recommendations were strong or conditional.

Results

We found 10 GDs, with only half (4/8) having a robust methodology. There were 31 recommendations concerning biomarkers. Among these, 24 (77.4%) recommendations were about single biomarkers, with lactate (23; 74.2%) and procalcitonin (8; 25.8%) most frequently recommended. Biomarker testing focused on prognosis in 28 (90.3%) recommendations. Overall, 16 (51.6%) recommendations were graded strong and 13 (42.0%) were conditional, which we displayed in an EGM.

Conclusions

The methodology of GDs concerning adult sepsis was poor. Our review calls for more prudent use of biomarkers in specific prognostic scenarios and in combination with standard clinical assessments. Enhancing the methodological quality of future GDs is essential to generate more valid and robust recommendations for optimising patient care.

The effect of virtual reality versus standard‐of‐care treatment on pain perception during paediatric vaccination: Study protocol for a randomised controlled trial

Abstract

Aims and Objectives

To study the effects of virtual reality (VR) on pain perception among a paediatric population while being vaccinated. We will also investigate the effects of VR on the fear experienced by children during the vaccination procedure, as well as parental satisfaction levels.

Background

Many studies, for example, in the fields of oncology, dermatology or plastic surgery, have described the benefits of using VR to reduce the perception of pain among paediatric populations. These results are encouraging, but their main limitations were the small sample sizes they included or their methodological design.

Design

This will be a randomised clinical trial.

Methods

SPIRIT guidelines were followed to report this protocol, and we will use the CONSORT and CONSORT-EHEALTH guidelines to report the randomised clinical trial. The sample will comprise 148 children aged 3–14 years who will come for vaccination at the Tres Forques Health Center. The participants will be randomly allocated into intervention group (VR; n = 74) or (the control group standard-of-care; n = 74) at a 1:1 ratio. The intervention group will view experiences with a VR headset as a distraction measure. The study variables will be the level of pain and fear perceived by the child during vaccination, parental satisfaction with the vaccination procedure, and sociodemographic and vaccination variables.

Results

The start of the study is planned for September 2020, and the results will be expected in September 2021.

Conclusions

This study aims to identify what measures reduce pain and fear in children during vaccination, which in turn, can help to improve the degree of parental satisfaction with these procedures.

Relevance to Clinical Practice

Vaccination is an independent function of the nursing profession. Identifying which distraction measures reduce the perception of pain and fear in the paediatric population will not only improve children's experiences but will also improve the satisfaction of both parents and children, thus increasing the degree of compliance with the vaccination schedule.

The effect of virtual reality versus standard‐of‐care treatment on pain perception during paediatric vaccination: A randomised controlled trial

Abstract

Aims and Objectives

To determine the effect of immersive virtual reality (VR) on perceived pain and fear in children during vaccination and parental satisfaction with the procedure.

Background

Virtual reality can reduce the perception of pain by children but only three studies have analysed its use during vaccination to date; these had small sample sizes and imperfect methodological designs.

Design

A randomised controlled clinical trial.

Methods

One hundred and sixty participants from the Tres Forques Health Center were randomly assigned to the intervention group (IG) (n = 82) in which distraction with immersive VR was used during the vaccination, while standard distraction techniques were used for the control group (n = 80). The primary outcome was pain (Wong–Baker FACES). Secondary outcomes included (Children's Fear Scale) and parental satisfaction with the vaccination procedure. Chi-squared tests were used for qualitative variables, relationships between quantitative variables were tested with Spearman correlations, and Mann–Whitney U- or Student t-tests were employed to assess the relationship between quantitative and qualitative variables.

Results

Compared to the controls, the children in the IG reported significantly less pain and fear, while parental satisfaction was significantly higher. Reported pain and fear did not differ according to the sex of the patient. Child age was not linked to fear but was related to pain: the younger the patient, the greater the pain they described.

Conclusions

Immersive VR effectively controlled pain and fear in children during vaccination and increased parent satisfaction with the vaccination process. Patient sex did not influence the level of pain and fear but age did.

Relevance to clinical practice

Improving vaccination experiences can reduce perceived pain and fear in children and increase parent satisfaction, thereby enhancing vaccination schedule adherence and improving group immunity.

Reporting Method

The CONSORT Statement for non-pharmacological randomised clinical trials were followed.

El enfoque narrativo en el proceso terapéutico

La terapia ocupacional es una profesión en la que el enfoque centrado en la persona resulta esencial para el éxito del proceso terapéutico. El uso de la narrativa es una herramienta que favorece esta perspectiva ya que pone en valor la importancia de la identidad ocupacional de las personas y la búsqueda de significados. El propósito del presente artículo es reconocer el uso de la narrativa como parte del proceso de terapia ocupacional. A partir del análisis de fuentes bibliográficas profesionales y de fuentes orales se identifica el enfoque narrativo como un componente esencial en el proceso terapéutico que está ligado a los valores inherentes de la profesión. El uso de la narrativa aparece en tres momentos clave del proceso terapéutico: evaluación, plan de intervención y revisión de los resultados lo que resulta de utilidad para comprender la realidad de las personas y orientar eficazmente la intervención terapéutica. Concluimos que la aplicación de este enfoque plantea oportunidades y desafíos para la profesión que pueden constituir una interesante área de investigación.

El enfoque narrativo en el proceso terapéutico

La terapia ocupacional es una profesión en la que el enfoque centrado en la persona resulta esencial para el éxito del proceso terapéutico. El uso de la narrativa es una herramienta que favorece esta perspectiva ya que pone en valor la importancia de la identidad ocupacional de las personas y la búsqueda de significados. El propósito del presente artículo es reconocer el uso de la narrativa como parte del proceso de terapia ocupacional. A partir del análisis de fuentes bibliográficas profesionales y de fuentes orales se identifica el enfoque narrativo como un componente esencial en el proceso terapéutico que está ligado a los valores inherentes de la profesión. El uso de la narrativa aparece en tres momentos clave del proceso terapéutico: evaluación, plan de intervención y revisión de los resultados lo que resulta de utilidad para comprender la realidad de las personas y orientar eficazmente la intervención terapéutica. Concluimos que la aplicación de este enfoque plantea oportunidades y desafíos para la profesión que pueden constituir una interesante área de investigación.

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