Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

As the HIV epidemic stabilises in Sub-Saharan Africa with effective antiretroviral therapy, cardiometabolic disorders (CMDs) remain the next major challenge for people living with HIV. Relationship dynamics and spousal support are important for the medical management of single diseases such as HIV, yet little is known about how couples manage the complexity of multiple competing health conditions and their synergistic effects on health. The Healthy Hearts study aimed to develop a conceptual model of dyadic management of HIV and CMDs, inform interventions for couples in Sub-Saharan Africa, and ultimately improve clinical practice and disease management for HIV and CMD comorbidities.

This study will enrol 250 couples who have at least one partner living with HIV and CMD (either hypertension or diabetes) for a prospective observational cohort study. Patients will be recruited from HIV and CMD clinics in Zomba and Blantyre, Malawi. Couples will attend four study visits at quarterly intervals over 12 months. Both partners are given interviewer-administered surveys and complete a clinical assessment. Regression techniques will be used to test associations between key constructs in our conceptual model, including communal coping, multimorbidity illness perceptions, relationship quality, psychosocial health, disease management (eg, adherence to lifestyle advice and medications) and disease outcomes (eg, viral suppression and CMD control). Findings will be used to identify elements to target in a couple-based intervention for CMD and HIV.

This study was approved by the University of California, San Francisco (HRPP (Human Research Protection Program); Protocol number 20–32126), and the National Health Sciences Research Committee of Malawi (Protocol number 21/04/2677). The results will be disseminated at local community meetings and conferences focused on relationships, CMDs and HIV and published in scientific journals.

Visual perception is a fundamental skill that plays a central role in sensing the external environment. Deficits can lead to impairments in everyday activities. Visual perception is known to be impaired in Alzheimer’s disease (AD). However, the extent to which visual perception is impaired in mild cognitive impairment (MCI), often a prodromal state of AD, has not been sufficiently investigated. This study aims to assess visual perceptual abilities in people with MCI and mild AD compared with healthy controls. It will also investigate whether executive functions, activities of daily living and intelligence are affected in this context, providing new insights into the research of visual perception together with MCI and mild AD.

People with MCI, mild AD and healthy controls will be assessed for cognitive deficits using the Syndrom-Kurztest (SKT). Visual perceptual performance will be assessed using the German version of the Developmental Test of Visual Perception-Adolescent and Adult: Second Edition (DTVP-A:2; Frostings Entwicklungstest der visuellen Wahrnehmung – Jugendliche und Erwachsene 2. Auflage). Activities of daily living will be assessed through the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) and the Bayer Activities of Daily Living Scale (B-ADL). Executive functions will be measured using the German adaptation of the Behaviour Rating Inventory of Executive Function - Adult (BRIEF-A) and intelligence will be assessed using the Matrix Reasoning and Vocabulary Test of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Data analysis will involve descriptive analyses, linear regression analyses, multivariate analysis of variance, mediation analysis and structural equation modelling.

This study has received approval from the Ethics Committee of Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Germany (number: 2023_009). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Registered at OSF https://doi.org/10.17605/OSF.IO/PM5AV

Micronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.

This will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B₁₂). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.

The study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.

All data will be made publicly available (deidentified) after the publication of the main impact paper.

NCT06810440.

Post-traumatic stress disorder (PTSD) constitutes a significant anxiety disorder that exerts substantial societal and familial impacts, while concurrently imposing an additional as well as a substantial burden on the healthcare system. Beyond the direct expenses incurred in its treatment, PTSD also gives rise to broader economic costs. The details of these costs in the UK are currently, we believe, unknown.

Our methodology was developed collaboratively with a collaborative advisory group of clinicians, patients, carers and other stakeholders. A comprehensive search strategy was devised to identify articles, including systematic reviews evaluating the economic costs linked to PTSD. We adhered to the National Institute for Health and Care Excellence checklist for economic evaluations. After applying our search strategy, the selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD.

PubMed, PsycInfo, PTSDpubs, EMBASE and Google Scholar were searched from January 1990 until January 2023; the search was revised and re-run in September 2024.

The articles must have been published originally in English and include a detailed evaluation of costs related to PTSD.

Two independent reviewers used standardised methods to search, screen and code included papers. After applying our search strategy, selected included papers were analysed to identify various cost categories contributing to the economic burden of PTSD. Detailed information on per-contact and per-session costs of healthcare variables was obtained at 2020/2021 prices. Additionally, with the advisory group, we ensured the validity of frequencies and unit cost figures associated with variables linked to PTSD. Further, indirect socio-economic costs arising from PTSD were computed.

By extrapolating from cost components identified, our findings indicate an average annual cost exceeding £14 780 per person. Given current 2020/2021 prevalence rates, this translates to an annual societal burden of £40 billion, a figure that does not encompass the many additional financial burdens stemming from PTSD, such as poor or inconsistent employment. This figure does not include the myriad intangible costs ranging from reduced quality of life to suicidality and countless other issues a person may suffer from as a result of PTSD. Finally, this number does not capture the breadth of impact, as it is difficult to quantify how the families, communities and social systems are adversely affected (both financially and otherwise) by the condition.

The economic and societal burden of PTSD in the UK is far greater than what extant research and common understanding indicate, as there is minimal awareness and information relating to indirect costs or ancillary effects such as discrimination, joblessness, substance use and other comorbidities. Ultimately, we found that there exists, conservatively, an annual excess societal burden of £40 billion, or approximately £14 780 per person. We demonstrated that PTSD is a significantly larger burden on society and individuals than estimated and that we are gravely underquantifying the cost of this increasingly prevalent condition.