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Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study: protocol for a national randomised pragmatic trial

Por: Sage · L. · Hart · E. · Meyer · N. · Hnilicka · O. · Penkin · A. · Poteat · T. C. · Aguayo-Romero · R. · Comstock · B. A. · STRIVE Publications Committee · Dy · G. W. · Blasdel · Corman · Deutsch · Gallo · Gore · Marsiglio · Sevelius · Solo
Introduction

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

Methods and analysis

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Ethics and dissemination

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

Trial registration number

NCT06436560.

Psychosocial burden in type 1 diabetes: a cross-sectional network analysis in the SFDT1 study

Por: Aguayo · G. A. · Martin · V. P. · Canha · D. · Cosson · E. · Arnault · G. · Delenne · B. · Guerci · B. · Berot · A. · Barraud · S. · Riveline · J.-P. · Fagherazzi · G.
Objectives

Using network analysis, which takes a holistic approach to health systems, we aimed to identify which psychosocial burden dimensions are the most central and, thus, critical to prioritising to improve the overall health of people with type 1 diabetes (PwT1D).

Design

A cross-sectional network analysis.

Setting

We used data from participants attending 44 diabetes centres in France, who were enrolled in the SFDT1 cohort study between June 2020 and February 2024.

Participants

We included 1430 PwT1D (52% women, median age (IQR) 41 (31–52.8) years) who had completed questionnaires on diabetes burden.

Outcome measures

The items from questionnaires on diabetes distress, fear of hypoglycaemia, quality of life, treatment burden and the impact of diabetes on education and work.

Results

The network was highly stable (correlation stability coefficient=0.75). We observed nine domains within the network; ‘Loneliness, Worrying & Burnout’ was the most influential. We further grouped the domains into three distinct syndromes labelled ‘Diabetes Distress’, ‘Treatment Burden’ and ‘Impact of Diabetes on Life’. These syndromes reflect the most relevant pillars of the psychosocial burden in PwT1D.

Conclusions

We observed that ‘Loneliness, Worrying & Burnout’ is the most influential psychosocial burden network domain to prioritise for type 1 diabetes care. This new network-based approach opens the path to defining personalised interventions targeting the most critical burden parameters to expect the most significant overall beneficial impact on PwT1D’s health.

Trial registration number

NCT04657783.

Satisfacción materna con la atención recibida durante el parto y puerperio y su relación con factores asociados

Objetivo. Evaluar el grado de satisfacción con los cuidados brindados durante el parto y el posparto en el Hospital Álvaro Cunqueiro (HAC) y explorar su posible relación con variables sociodemográficas y obstétricas. Metodología. Se realizó un estudio observacional descriptivo transversal. La población incluyó mujeres con partos entre enero y octubre de 2024 en el HAC. El muestreo fue no probabilístico y de tipo consecutivo. Para la recolección de datos, se utilizó un cuestionario ad hoc que recopiló información sobre variables sociodemográficas y obstétricas, complementado con el instrumento “Care in Obstetrics: Measure for Testing Satisfaction” (COMFORTS) en su versión validada en español. Resultados. La muestra estuvo compuesta por 319 mujeres. La mediana de satisfacción global obtenida con el cuestionario COMFORTS fue de 171 (RIC: 155–186), lo que indica un alto nivel de satisfacción general. Sin embargo, las áreas de cuidados en el posparto [Me: 46 (RIC: 40–53)] y al recién nacido [Me: 40 (RIC: 30–46)] fueron identificadas como susceptibles de mejora. Se encontró una relación estadísticamente significativa entre la paridad y la percepción de la calidad de los cuidados neonatales, así como entre el modo de finalización del parto y el grado de satisfacción materna con la experiencia del parto. Discusión. Aunque la satisfacción general con los cuidados obstétricos en el HAC es alta, existen áreas de mejora en el posparto y en la atención al recién nacido. Además, variables como la paridad y el modo de finalización del parto influyen en la percepción materna de los cuidados.

ABSTRACT

Objective. To assess the degree of satisfaction with the care provided during labor and postpartum at the Hospital Álvaro Cunqueiro (HAC) and to explore its possible relationship with sociodemographic and obstetric variables. Methodolgy. A cross-sectional descriptive observational study was conducted. The population included women with deliveries between January and October 2024 at the HAC. Sampling was non-probabilistic and consecutive. For data collection, an ad hocquestionnaire was used to obtain information on sociodemographic and obstetric variables, complemented with the instrument Care in Obstetrics: Measure for Testing Satisfaction (COMFORTS) in its validated Spanish version. Results.The sample consisted of 319 women. The median overall satisfaction with the COMFORTS questionnaire was 171 (IQR: 155–186), indicating a high level of overall satisfaction. However, the areas of postpartum [Me: 46 (IQR: 40–53)] and newborn care [Me: 40 (IQR: 30–46)] were identified as areas for improvement. A statistically significant relationship was found between parity and perceived quality of neonatal care, as well as between the mode of delivery and maternal satisfaction with the birth experience. Discussion: Although overall satisfaction with obstetric care at the HAC is high, there are areas for improvement in postpartum and newborn care. In addition, variables such as parity and mode of delivery influence maternal perceptions of care.

Satisfacción materna con la atención recibida durante el parto y puerperio y su relación con factores asociados

Objetivo. Evaluar el grado de satisfacción con los cuidados brindados durante el parto y el posparto en el Hospital Álvaro Cunqueiro (HAC) y explorar su posible relación con variables sociodemográficas y obstétricas. Metodología. Se realizó un estudio observacional descriptivo transversal. La población incluyó mujeres con partos entre enero y octubre de 2024 en el HAC. El muestreo fue no probabilístico y de tipo consecutivo. Para la recolección de datos, se utilizó un cuestionario ad hoc que recopiló información sobre variables sociodemográficas y obstétricas, complementado con el instrumento “Care in Obstetrics: Measure for Testing Satisfaction” (COMFORTS) en su versión validada en español. Resultados. La muestra estuvo compuesta por 319 mujeres. La mediana de satisfacción global obtenida con el cuestionario COMFORTS fue de 171 (RIC: 155–186), lo que indica un alto nivel de satisfacción general. Sin embargo, las áreas de cuidados en el posparto [Me: 46 (RIC: 40–53)] y al recién nacido [Me: 40 (RIC: 30–46)] fueron identificadas como susceptibles de mejora. Se encontró una relación estadísticamente significativa entre la paridad y la percepción de la calidad de los cuidados neonatales, así como entre el modo de finalización del parto y el grado de satisfacción materna con la experiencia del parto. Discusión. Aunque la satisfacción general con los cuidados obstétricos en el HAC es alta, existen áreas de mejora en el posparto y en la atención al recién nacido. Además, variables como la paridad y el modo de finalización del parto influyen en la percepción materna de los cuidados.

ABSTRACT

Objective. To assess the degree of satisfaction with the care provided during labor and postpartum at the Hospital Álvaro Cunqueiro (HAC) and to explore its possible relationship with sociodemographic and obstetric variables. Methodolgy. A cross-sectional descriptive observational study was conducted. The population included women with deliveries between January and October 2024 at the HAC. Sampling was non-probabilistic and consecutive. For data collection, an ad hocquestionnaire was used to obtain information on sociodemographic and obstetric variables, complemented with the instrument Care in Obstetrics: Measure for Testing Satisfaction (COMFORTS) in its validated Spanish version. Results.The sample consisted of 319 women. The median overall satisfaction with the COMFORTS questionnaire was 171 (IQR: 155–186), indicating a high level of overall satisfaction. However, the areas of postpartum [Me: 46 (IQR: 40–53)] and newborn care [Me: 40 (IQR: 30–46)] were identified as areas for improvement. A statistically significant relationship was found between parity and perceived quality of neonatal care, as well as between the mode of delivery and maternal satisfaction with the birth experience. Discussion: Although overall satisfaction with obstetric care at the HAC is high, there are areas for improvement in postpartum and newborn care. In addition, variables such as parity and mode of delivery influence maternal perceptions of care.

Role of the exposome in mental disorders: a scoping review protocol

Por: Gutierrez-Ortiz · C. · Hossain · B. · Dessenne · C. · Aguayo · G. A. · Ruiz-Castell · M.
Introduction

The development of mental disorders is multifactorial across the lifespan. The introduction of the exposome concept has enhanced the understanding of life-course environmental factors by encompassing the totality of environmental exposures. While most studies on chronic diseases have applied a single-exposure approach, the exposome approach remains underutilised in mental disorder research. There is a need to better recognise the environmental factors considered in exposome analysis of mental disorders, the methodologies used and the gaps reported. This scoping review aims to map the evidence on the relationship between the exposome and mental disorders across the lifespan, identifying and describing the methodologies used and highlighting the gaps reported.

Methods and analysis

This scoping review will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and the Population-Concept-Context approach. It will include observational and interventional studies involving populations of all ages in the community or healthcare settings. The search strategy will contain indexed terms in MEDLINE and will be adapted for CINAHL (EBSCO), Scopus, Embase and PsycINFO without restrictions on language or date of publication. For the selection of articles, two independent researchers will screen articles by title and abstract, followed by a full-text assessment. Afterwards, the extracted data will be summarised using a narrative and descriptive analysis.

Ethics and dissemination

Ethics approval is not required for this scoping review. Dissemination activities will include peer-reviewed publications and academic presentations.

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