To explore the impact of multiple long-term conditions (MTLCs) and a comorbid mental health condition on decision-making processes, attendance and engagement in NHS community-based therapy groups.

Qualitative in-depth interviews analysed using reflexive codebook analysis as part of a study within a trial.

Secondary community mental health teams from two UK sites.

Purposive sample of 20 participants recruited to a randomised controlled trial of group therapies (arts therapies and counselling) holding a mental health diagnosis and self-reported as having at least one additional physical health condition.

Six themes were constructed: (1) MLTCs influenced arts modality choices and goals; (2) importance of planning ahead to be organised; (3) the journey loomed over participants; (4) the impact of MLTCs on group attendance and participation; (5) the group was valued and important; (6) determination and fighting to get what I need.

Decisions about arts modalities and group attendance were based on a self-perceived level of felt capability. It was important for participants to plan in advance and feel informed ahead of making commitments, enabling them to prepare and manage symptoms. Travelling to the groups was dreaded, and many participants required support with travel in order to attend. Managing symptoms during the journey and groups was challenging; however, participants had a strong determination to uphold the commitment to attend despite their difficulties, as the group was highly valued.

MLTCs have a large impact on people’s capacity to engage in community groups, requiring additional planning and effort. The scale of this impact is often not recognised. Despite this, the benefits of groups for people with MLTCs are especially important, including motivation to leave the house, opportunities for socialisation and a means of reaching one’s own goals. Clinicians are recommended to accommodate the needs of MLTCs when designing community group interventions and consider multiple attendees with MLTCs in the group composition to improve attendance and group engagement.

ISRCTN88805048.

Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.

POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.

The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

NCT06100978.

Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

NCT06714630.

This study aims to evaluate a structured nurse-led follow-up programme coordinated by an advanced practice nurse (APN) as an alternative to conventional postdischarge care for patients with heart failure (HF). The main objective is to assess the clinical effectiveness and economic efficiency of the programme using quality-adjusted life years and healthcare costs related to resource use as outcome measures.

A quasiexperimental multicentre study will be conducted including an intervention group and a comparison group of patients discharged with HF from three public hospitals in the province of Málaga, Spain. The intervention group will be followed by an APN using a structured follow-up model, while the comparison group will receive standard care. Sociodemographic, clinical, quality of life, self-care, therapeutic adherence and healthcare resource utilisation data will be collected. The economic evaluation will be conducted from the perspective of the public healthcare system through a cost-utility analysis.

The study protocol has been approved by the corresponding Research Ethics Committee. All participants will provide written informed consent prior to inclusion. The results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.

Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.

This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.

This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.

Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%–39% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%–70% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.

This phase I/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5x10⁷ and 10x10⁷ cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.

The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comité de protection des personnes) Ouest 1 – Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de sécurité du médicament et des produits de santé) #2024-511821-75-00 (Sponsor number RC31/13/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.

NCT06636032.

The results will be disseminated through conventional scientific channels.

Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.

This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.

This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.

This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).

To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.

Genitourinary syndrome of menopause (GSM) is a prevalent condition among breast cancer survivors, often exacerbated by oncological treatments. Hormonal therapies are typically contraindicated in this population, necessitating effective non-hormonal interventions.

This randomised controlled trial aims to compare the effectiveness and cost-effectiveness of multimodal pelvic floor physiotherapy—comprising pelvic floor muscle training, non-ablative radiofrequency, therapeutic pelvic health education and the use of vaginal moisturisers—versus fractional CO₂ laser therapy combined with vaginal moisturisers in alleviating GSM symptoms in breast cancer survivors. Participants will be randomly assigned to one of the two intervention groups. Primary outcomes include measures of sexual function (assessed by the Female Sexual Function Index), subjective pelvic perineal pain intensity (measured with a 100 mm Visual Analogue Scale) and health-related quality of life (assessed by the Functional Assessment of Cancer Therapy-Breast), assessed at baseline, post-intervention and at 3, 6 and 12 months of follow-up. Statistical analyses will be conducted to evaluate the clinical efficacy and cost-effectiveness of the interventions.

The study protocol has been approved by the Ethics and Health Research Committee of the University of Alcalá (Reference: CEIP/2024/1/012). All participants will provide informed consent prior to inclusion in the study. Findings will be disseminated through peer-reviewed journals and conference presentations, and by engaging with patient associations and survivor groups through tailored materials.

NCT06721936.

Harms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment.

We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people.

This protocol was first approved by the St Vincent’s Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable.

ACTRN12624001061527.

Despite the increasing availability of non-invasive prenatal testing (NIPT), women’s experiences and motivations remain largely unknown. The use of NIPT is increasing in Italy; however, its organisation and access paths vary considerably. Women may undergo testing in either public or private facilities, where differences in pretest information, testing procedures and result communication may influence their experience. This study aims to investigate the attitudes, awareness and experiences of Italian women undergoing NIPT.

A cross-sectional anonymous online survey was conducted via social media in the period March–August 2023.

This nationwide study was conducted in Italy.

Women over 18 years old who had undergone NIPT were included.

Responders were 4154 women from every part of Italy. Most participants perceived the information provided during pre-NIPT counselling as extremely/very clear (68.2%) and helpful (72.5%), with higher proportions observed when counselling was delivered by geneticists. The mean knowledge score was 12.3 (range: 0–15) and was statistically higher for women with higher education level and prior NIPT experience. Half of the women reported no change in their perceived risk of having a child with chromosomal abnormalities after pre-NIPT counselling, and risk perception reduction was associated with lower knowledge scores. Pretest negative emotions were common (54.9%) and influenced by testing context, information sources and reasons for testing. Most women reported a positive impact from results (92.7%), shaped by information delivery made and prior knowledge. Regret was rare (3.0%) and linked to reasons and perceived risk changes. Overall, satisfaction was high (97.3%), particularly among those prioritising informed decision-making.

Improving personalised counselling and education throughout the NIPT journey seems crucial to minimise negative emotional impacts, highlighting the need for well-trained healthcare professionals.

Migrants in Australia are a vulnerable group to drowning, yet their participation in water safety programs remains limited. Previous research has focused on migrants already engaged in water-related activities, overlooking perceptions from those facing broader access challenges. Additionally, migrants have often been treated as a homogeneous group, neglecting intersectional factors such as age, gender, ethnicity and income level that influence access to programs.

This phenomenological qualitative study addresses these gaps by employing a novel approach to recruitment: conducting in-depth interviews with purposively selected recent migrants in a non-traditional setting—hairdressing salons—to capture diverse perspectives. A variety of ethnicities, ages and genders were recruited. Thematic analysis with an inductive approach was used to analyse the data.

Findings showed that most migrants were unaware of water safety programmes. While acknowledging the importance of water safety, they prioritised other pressures, such as income generation. However, affordable and culturally tailored training programmes for adults, delivered in culturally safe environments, may enable participation. Social connections, especially among students, could also be leveraged. Although parents rarely participated, they prioritised enrolling their children in swim training. Ethnicity-specific adaptations, such as native-language trainers, were considered desirable. Informants suggested disseminating water safety information to migrants before arrival in Australia or through community magazines and universities.

This study highlights the importance of intersectional, community-driven designing of water safety programmes and demonstrates the effectiveness of innovative recruitment methods in reaching underrepresented migrant populations. These findings provide actionable insights for developing inclusive and accessible drowning prevention strategies.