Despite the potential benefits of physiotherapy and physical activity, awareness remains limited among patients with sequela and healthcare professionals. This study aims to explore Danish physiotherapists’ (PTs) perspectives on barriers, facilitators and potential solutions to improve the care of sequelae after cancer in physiotherapy clinics.

This qualitative study used semi-structured interviews with Danish PTs, following a published research protocol and the Criteria for Reporting Qualitative Research checklist. Danish-speaking PTs working in private clinics in Denmark were eligible to participate and were selected via purposive sampling. Online interviews with PTs were conducted in June and July 2022.

A phenomenological approach was employed for data collection and thematic analysis, allowing researchers to set aside preconceptions. Preunderstandings were stated and revisited post-analysis for validation. The interview guide was developed and validated through discussions and pilot testing. A patient panel provided feedback on the interview guide. Interviews were conducted by a trained and experienced PT and transcribed using a standardised key.

Online interviews with 12 PTs were conducted. Five themes were identified: being aware of important physiotherapy competencies, PTs’ basic education and specialisation, patients’ resources, healthcare system and organisation, and sharing knowledge regarding sequelae from cancer and potential treatments. PTs emphasised the need for specialised competencies, emotional resilience and life experience. Patients experienced financial and psychosocial barriers, while systemic issues and poor communication hindered care. PTs suggested public lists of specialised providers and broader dissemination of knowledge to reduce stigma and improve access.

PTs identify clinical and systemic challenges requiring specialisation, improved collaboration and increased awareness to enhance rehabilitation and quality of life for cancer survivors.

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

NCT06116747.

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

There are more than 10 million deaf or hard of hearing people in the UK. While the deaf and hard of hearing population is heterogeneous, many of those with profound hearing loss are part of deaf communities (UK estimate around 120 000) which are defined minority communities. Many members of deaf communities are sign language users. Studies have shown that health behaviour and knowledge and health-related attitudes and beliefs are suboptimal among deaf and hard of hearing individuals, with reasons not well understood. This qualitative study aimed to explore the effectiveness of delivery of public health messages to sign language users and the potential methods of delivering public health messages beyond direct translation.

Qualitative study, using a phenomenological research approach and using interviews and focus groups. Interviews and focus groups were conducted initially between January and March 2019 and again between September and October 2022. Groups were held where logistically possible. The sessions followed a topic guide developed following review of the literature and discussion with the research team and with patient and public involvement input and pilot testing, but allowed for deviation for discussion depending on the responses given. Interviews took place in either British Sign Language (BSL) or English, depending on the language preference of the participants. Transcripts were analysed using thematic analysis.

Deaf community and associated stakeholders in Northern Ireland.

Participants were recruited from members of the deaf community and associated stakeholders across Northern Ireland and sampled purposively to ensure variation in age, sex, language, profession, educational level and region.

There were 16 one-to-one interviews and 5 focus groups held, in total involving 28 participants; 23 females and 5 males. 13 participants used BSL and 15 used English. Ages ranged from 23 to 77 years old. Participants included deaf community members (all BSL users and four English users) and key stakeholders involved in sign language and Healthcare. Interview duration ranged from 21 to 82 min. A number of themes were identified from the transcript analysis. These were broadly categorised into (1) current levels of awareness of public health messages, (2) barriers to accessing public health messages and (3) suggestions for facilitating improvement.

Participants reflected that, as with any heterogeneous population, levels of awareness of public health messages vary widely across Deaf communities. Overall levels of awareness were felt to be generally low and certainly much lower when compared with the hearing population. Particular difficulties were noted with regard to mental health, more abstract health-related concepts and preventative health measures. Participants identified not only communication barriers but also systemic, cultural and attitudinal barriers as contributing to this. Suggested next steps involve implementing legislative reforms to address systemic barriers, conducting awareness training to tackle attitudinal barriers, and launching culturally appropriate public health campaigns, all of which should be deaf-led to ensure the expertise and lived experiences of Deaf people guide the process.

For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.

STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.

Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.

NCT06493734 (ClinicalTrials.gov).

Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.

CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient’s home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.

214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.

The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.

CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.

ISRCTN11380842.

Chronic low back pain (LBP) is among the world’s leading causes of disability and declines in quality of life. Despite considerable financial and research investment, current interventions demonstrate only modest success or are associated with deleterious side effects. Furthermore, most treatment efforts are directed towards LBP that has already become chronic, rather than interventions capable of preventing pain chronicity in the first instance. Transcranial direct current stimulation (tDCS), a portable and cost-effective form of non-invasive brain stimulation, presents a potential means of targeting acute pain and preventing the transition to chronic pain. However, this approach has been limited primarily to experimental settings that require intensive appointments and specialist expertise. Thus, this assessor-blinded, participant-blinded, and therapist-blinded, randomised controlled trial aims to explore the effectiveness of home-based tDCS for improving pain and disability in people with acute LBP. This may provide insight into the potential for tDCS to expedite recovery from acute LBP and prevent pain chronicity.

40 individuals with acute LBP (onset

Ethics approval has been granted by the Western Sydney University Human Research Ethics Committee (H16334). Findings will be disseminated through scientific conferences and peer-reviewed journal publication.

Around 80% of the world’s smokers live in lower-middle income countries and smoking rates in China, Philippines and Indonesia are very high. Evidence suggests that most people begin smoking or become habitual smokers before reaching adulthood. This highlights the need for a smoking prevention intervention focused on young people. ASSIST (A Stop Smoking In Schools Trial) is a ‘peer-led’, school-based smoking prevention intervention, shown to be effective in the UK. The aim of the study is to assess the feasibility of conducting a full-scale effectiveness evaluation of an adapted version of the ASSIST intervention in China, Indonesia or the Philippines. However, due to issues with obtaining relevant approvals, China was removed from the trial with the approval of the funder and Trial Steering Committee, and the study will only be completed in Indonesia and the Philippines.

A feasibility mixed-methods cluster randomised controlled trial in 10 schools (six intervention, four control) in each of the two countries. Participants will be students aged c13–14 in mainstream (‘lower secondary’) schools. In addition to their usual education on smoking, intervention schools will receive the ASSIST intervention which is based on ‘diffusion of innovation’ theory, with new norms and behaviours promoted through: (1) peer modelling by locally influential individuals; and (2) information disseminated by them through their social networks. Control schools will continue with their usual education around smoking prevention.

The key outcome of the study is whether prespecified progression criteria relating to recruitment, retention, acceptability and feasibility have been met in order to progress to a larger cluster randomised controlled effectiveness trial in one or more of the countries. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery, exposure to and reach of the intervention. The feasibility of trial processes including outcome measurement will be assessed. An economic evaluation will estimate the costs of the ASSIST intervention. Statistical analyses will focus on feasibility criteria, and qualitative data will be analysed using a framework approach. Outcomes assessed will include self-reported smoking behaviour (own and that of friends and family); vaping and other forms of nicotine use; smoking-related attitudes and knowledge; smoking norms; self-esteem; self-efficacy; (all at baseline and 7 month follow-up) and exhaled carbon monoxide concentration (at follow-up only).

The trial has been approved by the University of Glasgow College of Medical, Veterinary and Life Sciences (MVLS) Ethics Committee (ref: 200210204), the De La Salle University Research Ethics Review Committee (ref: 2023-012C) and the Medical and Health Research Ethics Committee (MHREC); Faculty of Medicine, Public Health and Nursing; Universitas Gadjah Mada (ref: KE/FK/1205/EC/2022). The trial is sponsored by the University of Glasgow (Head of Research Regulation and Compliance—debra.stuart@glasgow.ac.uk). The sponsor will not have input in data collection, management, analysis and interpretation; write up and submissions for publication.

The study findings will be disseminated through peer-reviewed publications in expert journals and conference presentations and targeted communications to schools, policymakers and the public.

ISRCTN99140476.

Maintaining a satisfactory level of physical activity (PA) after cardiovascular rehabilitation in patients with coronary heart disease (CHD) is an important public health issue. However, more than half of patients do not maintain recommended levels of PA in the long term. There is growing interest in the use of cognitive-behavioural interventions that actively involve both health professionals and patients in education and research settings. We hypothesise that a personalised therapeutic education programme (PTEP) delivered by peers in collaboration with health professionals may help patients with CHD maintain appropriate levels of PA after participation in a cardiovascular rehabilitation programme (CRP).

We designed a prospective randomised controlled trial (the P-HEART-NER study) conducted jointly by health professionals and patients as experts or peers. The primary objective is to assess the impact of PTEP on objective levels of moderate to vigorous PA—measured by accelerometers—6 months after cessation of CRP. The secondary objectives are (1) to assess the impact of the intervention on light PA and sedentary time (also measured by accelerometry), (2) to evaluate changes in cardiovascular health indicators, including blood pressure, waist circumference and lipid profile, (3) to assess changes in motivation towards PA (using the Motivation Scale Towards Health-Oriented Physical Activity), PA self-efficacy (measured by the Exercise Confidence Survey) and quality of life (EQ-5D-5L). Patients will be enrolled at the end of a 4-week phase 2 CRP after a myocardial infarction. The intervention will consist of two teleconsultations and a group workshop at 2, 4 and 5 months, respectively, each jointly delivered by a peer and a health professional. The peers who will deliver the intervention will be patients who have participated in a phase 2 CRP with good compliance and who will be trained in motivational enhancement and cognitive behavioural therapies by health professionals and expert patients. The control group will not complete the PTEP.

Ethical approval was granted by the French regional ethics committee CPP Ile de France (Ref CPPIDF1-2023-DI36-Cat2). All participants will sign a written informed consent form. The results will be presented at conferences and published in peer-reviewed journals.

NCT05927363.

Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.

REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient's exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver's HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.

The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.

ISRCTN47894539.

Effective glucose control in surgical patients at risk of hyperglycaemia and hypoglycaemia is crucial, as these conditions can lead to surgical site infections, prolonged hospital stays and death. Fingerstick glucose monitoring (FSGM), the standard measurement of glucose, can be painful for patients and time-consuming for nursing staff, especially with hourly monitoring around surgery. Continuous glucose monitoring systems (CGMS) offer a less invasive alternative with better glucose regulation in outpatients.

The GLUCOSENS study compares the effects of CGMS and FSGM on point-of-care measurements and time-in-range (3.9–10.0 mmol/l) glucose levels (primary outcome), patient satisfaction and experience and nursing staff workload and experience in surgical wards. Furthermore, it evaluates CGMS accuracy during perioperative periods and medical imaging.

This Danish two-centre study will be conducted at the general surgical wards of Odense and Zealand University Hospital and will involve 305 patients over 18 months. The study is divided into three periods: first, a standard care period with point-of-care FSGM (110 patients); second, an intervention period with point-of-care CGMS (110 patients); third, another standard care period with point-of-care FSGM combined with a blinded sensor for comparing continuous glucose data from this period with continuous glucose data from the intervention period (85 patients). Furthermore, the study will include 24 nursing staff.

Data will be collected through medical file reviews on glucose levels, patient satisfaction questionnaires, a patient field study, an observation study of the nursing staff’s workload and qualitative interviews of nursing staff.

The study is registered with the Records of Processing Activities in the Region of Southern Denmark for research and quality projects (ID number: 23/36734) and has been approved by the Regional Scientific Ethical Committee in Southern Denmark (ID number: S-20240041). The results will be published in international peer-reviewed journals.

ClinicalTrials.gov Registry (NCT06473480)