The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial.

The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics.

The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal.

NCT06651164.

To translate and culturally adapt six self-report measures for depression, anxiety, post-traumatic stress disorder (PTSD) and somatic symptom disorder into Hindi and determine their diagnostic accuracy against a diagnostic clinical interview.

Cross-sectional validation study.

Rural Kangra, Himachal Pradesh, northern India.

480 perinatal (pregnant or within 12 months postpartum) and non-perinatal (not currently pregnant and not given birth within 12 months) women at one tertiary hospital and district-level Anganwadi (community health) centres.

Symptom endorsement; and discriminant validity, sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve (AUROC) of the Kessler Scale of Psychological Distress (K10), Patient Health Questionnaire (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Scale (GAD7), Perinatal Anxiety Screening Scale (PASS), PTSD Checklist (PCL-5) and Scale for the Assessment of Somatic Symptoms (SASS).

Complete data were available for 443 participants. Tiredness and body weakness were the most commonly endorsed symptoms among participants with common mental disorders. Among perinatal participants, the AUROC was highest for the GAD7 (0.88, 95% CI 0.79 to 0.96) and SASS (0.84, 95% CI 0.71 to 0.96). Among non-perinatal participants, the AUROC was highest for the SASS (0.92, 95% CI 0.88 to 0.97) and PHQ9 (0.91, 95% CI 0.86 to 0.96).

Measures which assess for fatigue, tiredness and somatic symptoms may help to identify women experiencing common mental disorders in this setting. Small numbers of participants with clinically diagnosed mental disorders in our sample mean results must be interpreted cautiously.

NCT05485701.

Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.

This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.

The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.

EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.

NCT06605079.

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.

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.

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.

NCT06436560.

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

NCT06093217.

The management of active patients with symptomatic knee osteoarthritis (KnOA) who are too young for total knee arthroplasty poses a specific challenge to clinicians. Research studies show that improving quadriceps muscle strength improves pain and function; however, aspects of the disease render it difficult for patients to achieve and maintain improvements. Recombinant human growth hormone (rHGH) is shown to increase the magnitude and duration of muscle growth when combined with exercise treatment in adult populations. Hence, rHGH combined with physical therapy may provide meaningful benefits in the treatment of KnOA.

This is a single-centre, double-blind, randomised trial to pilot a future Phase III trial from 2025 to 2028. Participants are aged 18–60 with clinical and radiographic evidence of isolated degenerative arthritis of the knee (patellofemoral or tibiofemoral). The investigational product is rHGH (Saizen (somatropin of rDNA origin, EMD Serono)) and a saline placebo. Participants will deliver the solution via subcutaneous injection area once per day at a dose of 0.5 mg HGH per body surface area (0.5 mg/m²) for 6 weeks, alongside participation in a lower limb strengthening programme developed by rehabilitation specialists. 17 participants will be recruited into each study arm.

The primary outcomes are feasibility (compliance with the study drug regimen for the 6-week administration period and enrolment rate) and safety (the proportion of minor and major adverse events between groups). The primary endpoint for these outcomes will be at 6 weeks. The secondary outcomes are knee extension strength, knee flexion strength, radiographic arthritis progression, thigh muscle circumference, MRI-measured quadriceps muscle volume and patient-reported outcome measures (Knee Osteoarthritis Outcome Score (KOOS), SF-20 and Tegner). The primary endpoint for these outcomes will be at 12 weeks, and the final endpoint will be 24 months, where final radiographic (X-ray) assessment will take place.

The primary outcome of compliance will be a calculation of mean compliance between groups, which can be analysed as a t-test after the treatment period. A two-sample, two-sided t-test will compare the clinical (secondary) outcome of greatest interest: knee extension strength at baseline versus week 6 compared between treatment groups. Other secondary outcomes will be compared using a simple linear mixed-effects model. The ² test will be used to determine whether the number of participants who made meaningful changes was different between groups. The null hypotheses are that the rHGH and placebo groups will have no difference in compliance rates, safety events, knee extension strength at 12 weeks and arthritis grade progression at 24 months.

This study has been approved by the Sunnybrook Research Institute Research and Ethics Board (#6427) and received a no-objection letter from Health Canada Clinical Trials. The primary sponsor is the Sunnybrook Centre for Clinical Trial Studies (CCTS). The findings of this study will be published in a peer-reviewed journal and presented at orthopaedic conferences.

NCT07036003.

Mothers’ mental health and life satisfaction may have been negatively affected due to challenges during the COVID-19 pandemic. Given the risk of future crises, knowledge of possible mitigating factors in this population is essential. This study aims to examine whether the pandemic affected the level of protective factors such as social support, physical activity and employment situation, and how these factors are associated with mental distress and life satisfaction.

Longitudinal cohort study.

Primary outcomes were mental distress (measured by the eight-item version of the Hopkins Symptom Checklist) and life satisfaction (measured by the Satisfaction With Life Scale). As the first step, we investigated changes in the levels of social support (defined by the number and frequency of social contact), physical activity (average hours of physical activity during a week), employment situation (actively working vs sick leave or unemployed), alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption) and relationship satisfaction (measured by the five-item version of the Relationship Satisfaction Scale).

We analysed data from two waves of the Norwegian Mother, Father and Child Cohort Study (n=~18 000 mothers); one pre-pandemic wave and one wave where half of the sample responded after the onset of the pandemic, with pandemic exposure being defined by questionnaire response timing rather than cohort recruitment. To assess changes in protective factors over time and pandemic exposure, we used difference-in-differences analyses and regression discontinuity design. Associations between protective factors with mental distress and life satisfaction, and possible moderation by pandemic exposure, were investigated using multiple regression models with interaction terms adjusted for potential confounders.

Apart from physical activity, which declined less across time in the pandemic group (B=0.09, 99% CI 0.05 to 0.12), protective factors did not change during the pandemic. Social support, employment situation and relationship satisfaction were associated with mental distress and life satisfaction, whereas physical activity showed a unique relationship with mental distress. Most associations were similar across pandemic exposure groups, except employment situation which appeared to have a stronger protective effect in the pandemic group (β=–0.12, 99% CI –0.24 to –0.00).

Changes over time in self-reported levels of protective factors were generally consistent among mothers independent of the pandemic. These factors appear to play an equally important role for mental distress and life satisfaction both under ordinary circumstances and during public health crises. Our findings enhance the understanding of how potential protective factors among mothers are associated with mental distress and life satisfaction in the context of a global stressor. Future studies should investigate additional mitigating factors that may be particularly relevant during global crises and explore the causal relationship between protective factors, mental health and life satisfaction.

This cross-sectional survey study evaluates the influence of international observerships organised by the coalition of healthcare professionals from academic institutions—the Ukrainian Alliance for Medical Exchange and Development (UA-MED)—on the professional development, knowledge transfer and clinical practice improvement of Ukrainian healthcare professionals during the war.

A total of 263 international observerships were facilitated for 204 Ukrainian medical professionals across the institutions in the USA, Canada, Europe and Australia during 2022–2024. To assess the impact of these observerships, a survey was administered focusing on overall satisfaction, procedural knowledge gained and challenges faced when implementing new techniques on return. The primary outcome was the success score, defined as a composite score of implementing new procedures, initiating quality improvement projects and knowledge dissemination efforts.

A total of 128 medical professionals from 45 Ukrainian institutions who completed 138 observerships in 27 institutions abroad participated in the survey (response rate of 62.7%). Observers varied by profession: surgeons (32.8%), radiation oncologists (14.8%), medical oncologists (11.7%), anaesthesiologists (11.7%) and others. Observerships lasted a median of 4 weeks; 74.1% included conference attendance. The average success and satisfaction scores were 6.5/10 and 9.3/10, respectively.

The majority (92.7%) reported a shift in perception of how to practise medicine and 75.5% implemented new procedures on returning to Ukraine. Encouraged to disseminate knowledge, participants provided informal training to colleagues (67.3%), prepared presentations for their institutions (65.5%) and national conferences (32.7%), incorporated learnt materials into educational lectures (39.1%) and engaged in all the activities above (15.5%).

The international observerships played an important role in enhancing the reported skills and knowledge of Ukrainian healthcare professionals during the war. Improvements were reported in clinical practice, medical education and the implementation of new procedures. The success of these observerships underscores the potential for similar programmes in other low-income and middle-income countries/upper-middle-income countries.

Returning research results that indicate risk of Alzheimer disease (AD) dementia—a disease for which no meaningful treatments or cure exist—to cognitively normal participants is controversial. AD is thought to begin many years before clinical signs and symptoms begin. During this time, individuals are cognitively normal but have biomarkers that indicate pathophysiological changes in the brain. With this study, we aim to evaluate the impact of returning research results on cognitively normal participants recruited from a longitudinal observational cohort on ageing at the Knight Alzheimer Disease Research Centre (Knight ADRC) at Washington University in St. Louis.

Our study uses a 2-year, delayed-start randomised clinical trial design. Participants are randomised to receive their research results either 2 weeks or 1 year after informed consent. This study was approved to recruit up to 450 participants with existing genetic and biomarker testing results from the Knight ADRC. During the study period, 260 individuals were eligible and approached for entry into the study. The primary cognitive outcomes are 1-year change in subjective cognitive score on the clinical dementia rating sum of box scores and the objective cognitive score on cognitive composite score. The primary psychosocial outcome is change in geriatric depression scale score 1 year after return of research results. The study was powered to answer primary outcomes with 140 participants (70 per study arm).

This study has been approved by the Washington University School of Medicine (WUSM) Institutional Review Board and the Human Research Protection Office. Results from these trials are shared through conferences and publications.

NCT04699786.

Hospital data can inform decision-makers with real-time evidence, yet it remains underutilised. This study aims to compare international health technology assessment (HTA) and regulatory real-world evidence (RWE) guidance, focusing on their applicability to hospital data.

We used a two-step sequential qualitative design: a scoping review and semi-structured interviews with HTA experts. We searched for RWE guidance for HTA in 12 countries: the UK, Germany, Italy, Spain, France, Finland, the Netherlands, Portugal, Denmark, Canada, the US and Australia, along with the European Medicines Agency and Food and Drug Administration. The expert interviews aimed to validate document selection and assess their applicability to hospital data. We analysed the interviews thematically.

We identified 19 guidance documents providing recommendations for RWE. Of these, four documents explicitly provided recommendations tailored to hospital data, while two others did so implicitly. The scope, definition and applications of RWE vary among guidance. Recommendations across all agencies mainly address the clinical-effectiveness domain, with limited guidance on quality-of-life and patient-reported outcomes, and none on real-world cost. The interviews identified seven themes playing a role in using hospital data: data-related, generalisability, ethical/legal, organisational, communication, governance and technology-related. Barriers included data availability, access, timeliness, quality, validation and heterogeneity. HTA experts emphasised the need for standardised policies.

There is a lack of harmonisation in assessing RWE among HTA and regulatory agencies. The available RWE guidance documents provide limited guidance on real-world hospital data. Considering their unique nature and to unlock their potential for HTA, we emphasise the need for more in-depth guidance tailored to the hospital context.

There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.

We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m²) and in the control group, the patients receive 1 infusion of RTX (375 mg/m²). The primary outcome of the study is the occurrence of the first relapse within 12 months following the initiation of treatment and secondary outcomes include the time to first relapse, the total number of relapses during the 24-month follow-up period, and any adverse events such as infusion-related complications, infectious complications, hypogammaglobulinaemia and neutropenia.

The study has been approved by the ethics committee (Comité de Protection des Personnes) of Sud Méditerrannée 2 and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.

NCT05786768.

2022-003336-59.

The 2013–2016 Western African outbreak of the Ebola virus disease (EVD), the largest recorded outbreak since the discovery of Ebola virus (EBOV) in 1976, destabilised local health systems and left thousands of survivors at risk for postacute sequelae, including vision-threatening uveitis. In an EVD survivor with severe panuveitis, the detection of persistent EBOV in the aqueous humour, long after clearance of acute viremia, focused clinical and research attention on the host-EBOV interaction in the unique terrain of ocular immune privilege. Despite the recognition that uveitis is common and consequential in EVD survivors, our understanding of pathogenesis is extremely limited, including the contributions of viral persistence and ocular-specific and systemic immune responses to disease expression. In this study protocol, we outline a multifaceted approach to characterise EVD-associated intraocular inflammation, including the clinical phenotype and complications; the presence of EBOV (or EBOV RNA/antigen) in ocular fluids and tissues; and associated local ocular-specific and peripheral immune responses.

We use an observational cohort design, which includes EVD survivors and close contacts of EVD survivors (ie, no documented history of EVD), and we propose disease (clinical examination and imaging), as well as molecular, virologic and immunologic characterisation, to meet research objectives.

This study has received Institutional Review Board approval from University of Nebraska Medical Centre, Emory University and Sierra Leone Ministry of Health. Findings will be disseminated through peer-reviewed publications.

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

CTIS EU 2024-514620-17-00

Persistent somatic symptoms and functional disorders are conditions requiring a biopsychosocial approach to care, often from multiple professionals. The fragmentation of care common in most health systems results in unsatisfactory and challenging care experiences. Collaborative care networks form an important route towards improving outcomes and the overall experience of care for patients and professionals. While we have a good idea of what such collaborative care networks can look like, we lack knowledge on the practicalities of implementing change in such networks.

The core objective of this study is to implement change in a collaborative care network for persistent somatic symptoms and functional disorders care. Our questions were twofold: first, what are examples of realistic action processes to improve such collaborative care networks? Second, what are, in our experience, conditions for an effective change process in such a collaborative care network?

Participatory action research approach embedded within an active regional network between May 2023 and May 2024. The process was led by an action group who selected objectives and related actions with the aim of improving the network, leading to better care for people with persistent somatic symptoms and functional disorders as well as improving satisfaction among professionals.

ALK Netwerk Salland, a regional network of professionals and experts-by-experience, focused on care of persistent somatic symptoms. This network is based in the Salland region in the east of the Netherlands, centred around the city of Deventer.

The action group was made up of local stakeholders including experts-by-experience and health and social care professionals, facilitated by a researcher-in-residence. Other participants included members of the regional network who provided input towards the different objectives.

Over the course of a year, three objectives were selected and enacted, including assessing the resources of the network, improving knowledge of treatment options and improving the shared vision of care. The process faced some challenges, such as changes in action group members and a lack of resources and time to enact changes. However, by having a trusted and engaged team, working with an active network, we were able to enact significant changes to the network, which may be sustained and built on through the ongoing action group.

Future participatory action research studies would benefit from a trusted and embedded researcher-in-residence, meaningful involvement early in the process of experts-by-experience, and serious consideration of realistic outcome measures to monitor for evaluation of changes made.

To examine how menstruation, contraceptive use and gender-based violence intersect to shape the sexual and reproductive health and autonomy of girls and young women in Kenya.

Qualitative study exploring girls and young women’s experiences with contraceptive use and menstrual management, using in-depth interviews and focus group discussions analysed through a reflexive thematic approach.

Four county-run family planning clinics in Uasin Gishu County, Kenya.

77 girls and young women aged 15–19 years (via 35 in-depth interviews and 7 focus group discussions) and 27 family planning clinic providers (via 5 focus group discussions).

Interviewees’ contributions suggest that covert contraceptive use, when discovered through menstrual monitoring, provoked intimate partner violence. Heavy menstrual bleeding, whether related to contraceptive use or not, was viewed as a sexual restriction and also fuelled intimate partner violence. Furthermore, the inability to afford sanitary pads, combined with the stigma surrounding menstruation, drove some girls and young women into exploitative sexual relationships, often resulting in unwanted or unintended pregnancies.

Menstrual bleeding and contraceptive use, both independently and in combination, affect girls and young women’s reproductive autonomy and overall health and well-being, particularly in relation to gender-based violence. Improving menstrual hygiene management, challenging the stigma and harmful norms tied to menstruation and contraception and ensuring safe contraceptive use are integral to improving sexual and reproductive health and autonomy and are requisite for preventing and eradicating gender-based violence.

A quality management system (QMS) in healthcare organisations encompasses not only policies, processes and necessary procedures but also the quality, safety and risk management of medical technology. Tactical and operational decision-making levels should be closely interconnected. Previous studies have shown that nurses at the operational level do have good awareness of patient safety, but especially in teams with a strong degree of self-organisation, interaction with tactical levels is an issue. The tactical level is regarded as crucial for linking top-down policy with bottom-up experiences.

To explore the perspectives of homecare employees working at a tactical level regarding (1) the quality frameworks used within their organisation according to these employees, (2) the extent to which these employees are aware of the procedures for the safe use of advanced medical technologies (AMTs), such as infusion pumps, within their organisation and (3) how these employees perceive the patient safety culture related to the use of AMTs within their organisation.

A qualitative descriptive research design was employed.

15 semistructured interviews were conducted online with purposively sampled participants from homecare organisations across the Netherlands that had previously participated in related studies. The participants were employees at the tactical level within these homecare organisations, responsible for the quality and safety of AMTs.

All participating organisations possess a QMS; however, only seven indicated that there is a dedicated plan for ensuring the quality and safety of AMTs. National protocols for the use of AMTs and the supplier’s maintenance protocols are commonly followed. Although some participants say that their organisation has no formal procedure for resolving malfunctions with AMTs, all participants know pathways for solving problems. Tailored training programmes for nurses on AMTs are provided, but often without testing knowledge and skills or formal registration of nurses’ competence. Professionals report an incident on a separate form in the electronic client file or via a separate reporting system. However, there is no uniformity within organisations about handling incidents. Most interviewees state that, in any case, incidents are discussed within the team. On the dimension ‘reporting, evaluating and learning from incidents’ of the ‘Instrument for Self-Evaluation of Patient Safety Culture’, the prevailing patient safety culture is, on average, characterised as ‘proactive’.

There is a lack of uniformity regarding quality and safety procedures for the use of AMTs in homecare organisations, and structured policies for the implementation, use and maintenance of AMTs are needed. This study identified additional risk factors regarding individual competencies in the use of AMTs at home. Employees at the tactical level seem to be more positive about the patient safety culture with AMTs in their organisations than nurses at the operational level are.

Coronary revascularisation practices have evolved over the last three decades. This study sought to examine the variations in percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) rates, alongside mortality from acute myocardial infarction (AMI) across a group of 16 high-income countries between 2006 and 2020.

Retrospective observational analysis using data from the Organisation for Economic Co-operation and Development (OECD) database between 2006 and 2020. Estimated annual percent change in revascularisation was analysed using Joinpoint regression model, and mortality rates were evaluated using the locally weighted scatterplot smoothing model.

Publicly available data on PCI and CABG procedure rates alongside AMI mortality rate from 2006 to 2020.

16 countries from the OECD database.

Not applicable.

Standardised PCI and CABG procedure rates and AMI age-standardised mortality rate (ASMR) from 2006 to 2020.

Over the 15 year period, 14.0 million PCI and 2.8 million CABG procedures were collectively recorded across 16 countries. PCI rates varied among nations, but from 2006 to 2020 increased in 11 of the 16 nations overall, led by Finland (+36.0%), Ireland (+34.5%) and France (+31.5%). Meanwhile, CABG rates declined in 14 out of the 16 countries, with Luxembourg (–71.3%), the UK (–62.6%) and Finland (–60.6%) experiencing the most substantial decreases. Throughout the study period, the PCI-to-CABG ratio increased, while AMI ASMR decreased consistently across all countries.

Despite evidence supporting CABG over PCI in specific scenarios, CABG rates have declined, and PCI rates have increased. Possible factors for this trend may include patient preference and advancement in interventional techniques. The varied use of PCI among these nations, alongside a sustained decline in AMI mortality rates, may be expected given the importance of optimal medical therapy in the management of ischaemic heart disease. The results further suggest the significance of factors beyond revascularisation in driving improved outcomes.