Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

The standard treatment for high-grade squamous intraepithelial lesions is excisional involving the uterine cervix, while surveillance is an acceptable approach for low-grade squamous intraepithelial lesions. There is controversy about excisional treatment on pregnancy outcomes. The objective of this study was to determine pregnancy outcomes in women living with and without HIV who underwent excisional treatment for high-grade cervical intraepithelial lesions.

This retrospective cohort study compared the pregnancy outcomes of women with and without HIV who were or were not treated for cervical intraepithelial lesions. A cohort of 488 women with and without HIV infection who did or did not receive excisional treatment for cervical intraepithelial lesions between 2009 and 2022 was enrolled. Adverse pregnancy outcomes (preterm delivery and pregnancy loss) in women with and without HIV, untreated or treated for cervical dysplasia, were recorded and analysed. The significance of the obtained results was judged at the 5% level.

The study was conducted at all Academic Model Providing Access to Healthcare-Kenya satellite sites, which offer cervical cancer screening and treatment for cervical dysplasia in western Kenya. The Moi Teaching and Referral Hospital was also included.

A cohort of 488 women aged between 20 years and 49 years, with and without HIV, diagnosed and treated for high-grade cervical intraepithelial neoplasia, and those followed up for low-grade cervical intraepithelial neoplasia between 2009 and 2022, were included.

The study was interested in adverse pregnancy outcomes, particularly pregnancy loss and preterm delivery following cervical excision treatment for high-grade cervical intraepithelial lesions.

After adjustment for confounding factors, excisional treatment involving the uterine cervix—particularly cold knife conisation—was associated with higher odds of adverse pregnancy outcomes (OR 13.1; 95% CI 1.1 to 137.1; p=0.032). A prior history of adverse pregnancy outcomes was also strongly associated with subsequent adverse outcomes after treatment (OR 37.7; 95% CI 13.8 to 102.7; p

Adverse pregnancy outcomes after excisional treatment of the uterine cervix for high-grade squamous intraepithelial lesions are multifactorial and were associated with cold knife conisation and prior adverse pregnancy outcomes, while maternal HIV infection was not independently associated with adverse outcomes.

Malaria remains a major public health challenge in India, with transmission dynamics varying widely across ecological, epidemiological, sociobehavioural and health system contexts. Achieving the national malaria elimination target by 2030 requires integrated, context-specific evidence to design effective interventions. This study aims to generate a comprehensive understanding of malaria transmission and factors surrounding it across diverse eco-epidemiological settings in India by assessing malaria burden, identifying determinants of transmission, evaluating health system performance and equity, characterising vector bionomics and insecticide resistance, and examining the influence of environmental drivers.

This longitudinal, multicentric study will be conducted in collaboration with the national programme in 12 districts spanning 10 states in India, covering a population of around 25 000 individuals representing varied ecological contexts (urban, periurban, rural, forest-foothill and coastal) and malaria endemicity levels. In each district, two clusters (villages) with a population of 1000 individuals will be included. A baseline mass survey will estimate malaria prevalence using bivalent rapid diagnostic tests (RDTs) and blood smear microscopy, with low-density parasitaemia detected by PCR in a subset of RDT-negative samples. Participants will be followed for 1 year, with monthly screening of symptomatic individuals using RDT and microscopy, and testing a subset of asymptomatic individuals to detect subclinical infections. Sociobehavioural data will be collected through structured interviews and household observations, with purposive inclusion of vulnerable groups, pregnant women, migrants, elderly persons, individuals with disabilities and tribal populations to assess equity dimensions through mixed-methods approaches. Health system performance will be evaluated through key informant interviews with programme officials, health workers, patients, private practitioners and traditional healers. Entomological surveillance will document vector species composition, density, infection rates and assessment of susceptibility status and intensity of insecticide resistance to commonly used public health insecticides. Environmental variables, including temperature, rainfall and humidity, will be linked with entomological and epidemiological data to explore spatiotemporal relationships.

The protocol was approved by the Institute Human Ethics Committee of ICMR-Vector Control Research Centre (IHEC 03-0125/N/F). All standard ethical practices will be adhered to. The findings will be shared with stakeholders and published in reputed open-access journals.

Nutrition counselling is recommended after pancreatic cancer surgery given the complex nutritional problems patients experience. In practice, access and delivery of nutrition counselling after pancreatic surgery varies across settings. To address this gap, our study team developed the Support Through Remote Observation and Nutrition Guidance (STRONG) programme, an implementation strategy that addresses common barriers to nutrition care delivery in oncology.

The STRONG programme includes a standardised protocol to specify the timing and amount of nutrition counselling that should be delivered and patient-mediated implementation strategies including collection of patient-reported information, an educational brochure summarising common nutrition problems and recommended dietary strategies after pancreatic surgery and a question prompt list for the patient-dietitian encounter. A pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the STRONG programme compared with usual care in pancreatic cancer surgery patients after hospital discharge (n = 80). The trial is designed to be pragmatic and integrated into existing workflows and clinic teams. The primary goal will be to compare feasibility and acceptability outcomes against pre-planned benchmarks. Data will be collected from patients and caregivers and healthcare providers who assist with STRONG implementation. Secondary goals include collecting preliminary data on effectiveness and implementation outcomes that will support a future definitive hybrid implementation-effectiveness trial.

This study was approved by the Moffitt Cancer Center Institutional Review Board of Record, Advarra (Pro00071143). Participants will be required to provide written consent prior to enrolment. Study findings will be disseminated through plain language summaries, conference abstracts and peer-reviewed publications.

ClinicalTrials.gov NCT06001268. Registered on 21 August 2023, prior to participant enrolment.

Viral hepatitis B (HBV) and C (HCV) infections remain major public health threats in Ghana, with prevalence rates significantly higher in prison populations than in the general population. Despite this, incarcerated individuals are frequently excluded from national testing and treatment programmes. Overcrowding, poor sanitation and limited access to healthcare create a high transmission risk. There is an urgent need for targeted, evidence-based interventions to address this health inequity and support Ghana’s progress towards viral hepatitis elimination.

This protocol describes a study designed to evaluate the effectiveness of a multicomponent targeted educational intervention in increasing knowledge, intention to test, testing uptake and treatment initiation for HBV and HCV among adult prison inmates in the Greater Accra and Eastern Regions of Ghana.

A cluster randomised controlled trial (RCT) with a 1:1 parallel design will be conducted in eight prisons stratified by gender (six male, two female) with 208 inmates per arm. The intervention group will receive the Prison Education for Prevention of Hepatitis Intervention, comprising an education programme (posters, infographics, film screenings, peer-led discussions and structured health education) alongside HBV and HCV testing, treatment and care linkage. The control group will receive standard health education and basic printed materials. Testing intentions, uptake, prevalence and treatment outcomes will be measured. Cost-effectiveness analysis will inform sustainability and scale-up. The primary endpoint is uptake of hepatitis B and C testing. Secondary outcomes include changes in hepatitis knowledge and testing intentions, prevalence of hepatitis B and C, treatment uptake among diagnosed inmates, linkage to hepatitis care services and cost-effectiveness of the intervention.

Data will be analysed, accounting for prison clustering, using mixed-effects models and regression methods. Outcomes include testing uptake, knowledge, intentions, prevalence, treatment initiation and sustained virologic response, adjusted for key covariates. Baseline characteristics and intervention reach will be summarised descriptively. Analyses will follow intention-to-treat and Consolidated Standards of Reporting Trials guidelines. Cost-effectiveness will estimate Incremental Cost Effectiveness Ratio (ICERs) per inmate tested, infection detected and treatment initiated.

The RCT was approved by the College of Health Sciences ethics and protocol review committee (no. CHS-E/M.1-P 4.7/2025–2026). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Ghanaian Prisons and Healthcare systems.

PACTR202512558588684.

The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.

This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.

The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.

This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.

The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.

NCT06154889.

Hypertension is the leading risk factor for death globally. Undiagnosed hypertension is common, but the incidence in hospitalised patients is unclear. There are calls for universal facility-based screening for hypertension among all attending patients. The hospital inpatient setting, where blood pressure (BP) is measured routinely and repeatedly, presents an ideal opportunity. However, international hypertension guidelines do not include inpatient BP thresholds for diagnostic or treatment purposes. We investigated the performance of current UK community BP thresholds for diagnosing hypertension in the hospital setting.

Investigate the diagnostic performance of the current UK ambulatory BP diagnostic thresholds for systolic and diastolic hypertension in the hospital setting against the reference test of community-based ambulatory BP monitoring (ABPM).

A prospective diagnostic accuracy study.

Hospital inpatients admitted to three UK centres were approached. Follow-up ABPM was delivered in the community.

Eligible patients were aged between 18 and 80 years, with no prior diagnosis of, or prescription for hypertension, and whose mean cumulative daytime BP was 120 mm Hg to 179 mm Hg systolic and ≤109 mm Hg diastolic from the 24th hour of their hospital admission.

Participants received 24-hour ABPM 4–26 weeks post-discharge, as the reference test for hypertension, with UK diagnostic thresholds of an average daytime BP of ≥135 mm Hg systolic and ≥85 mm Hg diastolic applied. Participants found to be severely hypertensive at the ABPM fitting appointment were also considered reference-test positive but did not proceed with ABPM.

The diagnostic performance of a mean daytime in-hospital BP of ≥135 mm Hg systolic or ≥85 mm Hg diastolic (index test) for the prediction of hypertension diagnosed on ABPM (reference test) was assessed using sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) as primary outcome measures. Additionally, we explored the accuracy of a range of alternative in-hospital systolic and diastolic BP thresholds against the same reference test.

351 participants were enrolled and 206 completed the study protocol. The average age of the 206 participants was 53 years, 55% were male, and 91 (44%) had daytime community hypertension on ABPM reference testing. Of 107 participants with raised in-hospital daytime BP, 59 (55%) had daytime community hypertension. When assessing the performance of the index test for detecting daytime community hypertension, sensitivity was 65% (59/91, 54% to 75%) and specificity was 58% (67/115, 49% to 67%). The PPV was 55% (59/107, 45% to 65%) and NPV was 68% (67/99, 58% to 77%), respectively. A further 45/206 participants (23%) had night-time community hypertension when assessed using European diagnostic thresholds for nocturnal hypertension (120 mm Hg systolic or 70 mm Hg diastolic), while 25/107 of those with raised in-hospital daytime BP (23%) had night-time community hypertension. When assessing the performance of the index test for detecting either day or night-time community hypertension, sensitivity was 62% (84/135, 53% to 70%) and specificity was 68% (48/71, 55% to 78%). The PPV was 79% (84/107, 70% to 86%) and NPV was 48% (48/99, 38% to 59%).

Undiagnosed hypertension is common in hospitalised patients, particularly those with raised in-hospital BP. While in-hospital BP alone is an imperfect predictor and should not be used as a stand-alone diagnostic test, this could serve as a trigger for further assessment of BP in the community after discharge.

The study protocol was registered with the ISCTRN Registry (ISRCTN80586284).

Although breastfeeding is associated with lower postnatal depression and anxiety, limited research exists regarding long-term maternal mental health outcomes. This study examined the association between breastfeeding and depression and anxiety in women of later reproductive age (mid 30s to menopause).

This was a 10-year prospective longitudinal cohort study. Self-reported questionnaires were used to collect lifetime breastfeeding behaviour at 10 years, and health history including depression, anxiety and medication use was collected at each study timepoint.

A tertiary level maternity hospital in Dublin, Ireland.

168 parous women from the ROLO Longitudinal Cohort with lifetime breastfeeding behaviour and health history data available at 10 years were included (22% of total cohort). Women currently pregnant or breastfeeding at 10-year follow-up were excluded.

Mean (SD) age at study end was 42.4 (3.8) years. 72.6% (n=122) of women reported ever breastfeeding. Median lifetime exclusive breastfeeding was 5.5 weeks (IQR 35.8, range 0–190). 37.5% of women (n=63) breastfed for ≥12 months over their lifetime. 13.1% (n=22) reported depression or anxiety at 10 years, and 20.8% (n=35) reported depression or anxiety over the whole study period. Ever breastfeeding was associated with less depression and anxiety at 10 years (OR 0.34, 95% CI 0.12 to 0.94, p=0.04). Ever breastfeeding, longer exclusive breastfeeding and lifetime breastfeeding ≥12 months were associated with lower depression and anxiety over the whole study period (ever breastfeeding OR 0.4, p=0.03; exclusive breastfeeding OR 0.98/week, p=0.03; lifetime breastfeeding ≥12 months OR 0.38, p=0.04).

There may be a protective association between breastfeeding and self-reported depression and anxiety. Further studies are required to confirm the findings.

ISRCTN54392969.

Lesbian, gay, bisexual, trans, intersex, queer/questioning and other sexual and gender minorities (LGBTIQ+) face systemic barriers and discrimination in healthcare settings, leading to significant health disparities. These challenges persist in palliative and end-of-life care (PEOLC), where older LGBTIQ+ people often lack family support and experience social isolation. Despite the increasing ageing of the LGBTIQ+ population in Switzerland, there is limited evidence on their specific PEOLC needs. Additionally, healthcare providers’ knowledge and practices regarding LGBTIQ+ inclusivity in these settings remain understudied. This study aims to address these gaps by co-creating knowledge and developing best practice recommendations for inclusive PEOLC in Switzerland.

This study employs a mixed-methods participatory action research approach across three work packages (WPs). WP0 ensures participatory engagement through advisory boards, workshops and co-design processes across Switzerland’s four linguistic regions. WP1 investigates the palliative and PEOLC needs of LGBTIQ+ people and their (chosen) families through qualitative interviews (n30) and a quantitative survey embedded in the Swiss LGBTIQ+ Panel. WP2 explores healthcare providers’ perceptions and practices regarding LGBTIQ+ patients through qualitative interviews (n30) and a nationwide quantitative survey among palliative and PEOLC professionals. Data will be analysed using reflexive thematic analysis for qualitative data and multivariate regression models for quantitative data. Findings will be synthesised through a specific data integration framework, integrating community and healthcare perspectives.

This study has received ethical approval from the relevant Swiss Ethics Committees. The participatory approach promotes inclusivity, empowering LGBTIQ+ people and healthcare providers in shaping recommendations. Findings will be disseminated via peer-reviewed publications, policy briefs, stakeholder workshops and the co-created Rainbow Book, a best-practice guide for LGBTIQ+ inclusive palliative and PEOLC in Switzerland.

Despite evidence of the cost-effectiveness of physical activity (PA) promotion interventions in healthcare settings, translating them into practice remains challenging. This study aimed to identify implementation barriers and facilitators of a Portuguese PA consultation programme implemented in primary healthcare of the Portuguese National Health Service. Additionally, it sought to inform future implementation strategies, using a theoretically based approach.

Qualitative interview study, using both deductive and inductive approaches.

Primary healthcare units across all health administration regions of mainland Portugal.

Twenty-eight participants (six medical doctors, five exercise professionals and 17 patients) from all health regions of the country, involved in the implementation of the Portuguese PA prescription consultation.

Fifty-three categories of determinants were identified, using the Tailored Implementation for Chronic Diseases framework. Key barriers included ineffective referral processes to the consultation, challenges in integrating the intervention with existing healthcare demands and insufficient local/regional prioritisation of PA promotion. Key facilitators included high intervention acceptability, diverse community PA resources and good interpersonal skills of implementers. Drawing on the Behaviour Change Wheel, theoretically based inputs to design strategies addressing each barrier were provided.

The implementation of PA consultation was influenced by a broad range of determinants. The most frequently reported barriers are primarily structural and opportunity-related, suggesting system-level implementation strategies are most appropriate. Future strategies should consider implementing clinical standards/orientations for PA promotion, providing institutional incentives based on the attainment of PA indicators, expanding consultation coverage and diversifying referral strategies, reinforcing health system-community partnerships and strengthening training opportunities for implementers. These findings offer relevant insights for enhancing the future implementation of PA consultations, for scaling them up and, ultimately, to increase their effectiveness.

To investigate the efficacy of two volumes of acute isometric wall squat exercise on pain sensitivity (primary outcome: pressure pain threshold (PPT)) and intensity (secondary outcome) in adults with knee osteoarthritis.

A parallel-group randomised controlled trial.

Outpatient physiotherapy clinics at hospitals in Saudi Arabia.

Participants (n = 90; mean (SD) age 49.0 (13.0) years) with chronic knee osteoarthritis, diagnosed by a specialist orthopaedic physician using radiographic evidence and clinical judgement, were recruited via two tertiary hospitals in Saudi Arabia.

Participants were stratified by sex and randomly allocated to one of three groups: isometric single-repetition wall-squat (ISO-SR; one repetition of a 3-min wall squat or to volitional fatigue at a 100° knee joint angle), isometric multiple-repetition wall-squat (ISO-MR; three repetitions of the same intervention) and control (quiet sitting for 7 min).

PPT was measured at the calf (primary site of interest), lumbar spine and forearm using a pressure algometer. Pain intensity was assessed using a visual analogue scale. Primary analyses compared changes between intervention and control groups. All participants were included in the ITT analysis.

The ISO-MR group had higher mean PPT ratings immediately postintervention in the calf (mean difference=9.4 (95% CI 5.6 to 13.2), p

Both the ISO-SR and ISO-MR exercises to volitional fatigue reduced pain sensitivity in patients with knee osteoarthritis. Neither exercise volume changed clinical pain intensity.

ClinicalTrials.gov registry (ID: NCT05605444).

Preoperative administration of tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirements in total hip arthroplasty (THA), but optimal dosing remains uncertain due to the narrow range of doses explored in prior studies. This study aims to define the dose–response of intravenous TXA in THA, focusing on perioperative haemoglobin drop to improve blood-sparing effect.

This monocentric, double-blind, placebo-controlled, parallel-group, dose-finding study will enrol 170 adults undergoing THA, aiming to randomise 150 patients. Participants will be allocated using a minimisation technique with a random component in equal proportions to receive either placebo or one of four intravenous TXA doses: 300 mg, 500 mg, 1000 mg or 3000 mg. Dose selection and sample size are based on a model-based meta-analysis that employed a maximum effect (Emax) model with a maximum effect of 40% and an ED50 (dose providing 50% of Emax) of 400 mg. The primary outcome will be the relative perioperative haemoglobin drop at postoperative day 3. Secondary outcomes include TXA exposure and perioperative fibrinolytic activity as measured by D-dimer levels. Only patients receiving the allocated study treatment will be analysed (modified intention-to-treat population). The dose–response relationship for the primary outcome will be analysed using non-linear mixed-effect models.

The study protocol was approved by the French ethics committee (Institutional Review Board Sud Méditerranée V) and the French National Agency for the Safety of Medicines and Health Products (ANSM). Results will be disseminated at conferences and published in peer-reviewed journals.

CTIS 2022-502532-38-01; NCT03822793.

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

This study aimed to assess construct validity against commonly used patient-reported outcome measures (PROMs), test–retest reliability and responsiveness of seven Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CATs) in Dutch adults with type 2 diabetes (T2D), and assess their acceptability in healthcare providers and people with T2D.

A cross-sectional observational study in people with T2D and qualitative study involving both people with T2D and healthcare professionals.

Participants with T2D were recruited from the ongoing Hoorn Diabetes Care System cohort in the West-Friesland area of the Netherlands. Additionally, people with T2D and advanced chronic kidney disease were recruited at the outpatient clinics of Amsterdam University Medical Centre and ‘Niercentrum aan de Amstel’, both in the Amsterdam area of the Netherlands. The healthcare professionals involved in the qualitative part were recruited at the Amsterdam University Medical Centre.

314 people with T2D (age 64.0±10.8 years, 63.7% men).

Participants completed seven PROMIS CATs (assessing (1) Physical Function, (2) Pain Interference, (3) Fatigue, (4) Sleep Disturbance, (5) Anxiety, (6) Depression and (7) Ability to Participate in Social Roles and Activities), and PROMs measuring similar constructs. After 2 weeks and 6 months, participants completed the CATs measures again, together with seven Global Rating Scales (GRS) on perceived change in each domain. Construct validity was assessed using Pearson’s correlations. Test–retest reliability was assessed by the intraclass correlation coefficient (ICC). Measurement error was assessed by the standard error of measurement (SEM) and minimal detectable change (MDC). Responsiveness was assessed by correlations between change scores on the PROMIS CAT and GRS. Acceptability was assessed through focus groups and interviews in healthcare providers and people with T2D.

Except for Fatigue, all PROMIS CAT domains demonstrated sufficient construct validity, since ≥75% of the results was in accordance with a priori hypotheses. All seven PROMIS CATs showed sufficient test–retest reliability (ICCs 0.73–0.91). SEM and MDC ranged from 2.1 to 2.7 and from 5.7 to 7.4, respectively. Responsiveness was rated as insufficient in this study design as there was almost no change in participants’ own rating of their health compared with 6 months ago according to a global rating of change.

During the focus groups and interviews, healthcare providers and people with T2D agreed that CATs could serve as a conversation starter in routine care, but should never replace personal consultations with a doctor. If implemented, participants would be willing to spend 15 min to complete the PROMIS CATs.

The PROMIS CATs showed sufficient construct validity and test–retest reliability in most domains in people with T2D. Responsiveness needs to be evaluated in a population with poorer diabetes control or in a study design with longer follow-up. The CATs are well accepted to be used in care to identify relevant topics, but should not replace personal contact with the doctor.

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

An action research study.

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.

Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.

NCT06774820.

Depressive symptoms are common in the growing geriatric surgical population and are associated with important patient-centred surgical outcomes, including postoperative delirium, discharge to postacute care facility and decline in functional status. Few interventions have been developed to address depressive symptoms in the perioperative setting.

We designed a feasibility and acceptability study of a nine-session problem-solving therapy (PST) telehealth perioperative intervention aimed at reducing postoperative functional decline and depressive symptoms among at-risk older adults undergoing major surgical procedures. Acceptability will be evaluated using a patient-centred five-question survey, assessing participant satisfaction and perceived usefulness of the perioperative intervention. A feasibility assessment will rely on objective measures including ease of participant recruitment, frequency and timing of delivery of intervention sessions and retention of participants throughout the duration of the intervention. With respect to the efficacy of the proposed PST intervention, the primary outcome of interest is postoperative functional status, as measured by the WHO Disability Assessment Schedule 2.0 at the 6-month postoperative time point. The secondary outcome of interest is the degree of depressive symptoms as assessed by the Patient Health Questionnaire-9 at both 3 months and 6 months postoperatively. The broader goals of this study include: (1) assessing the feasibility of implementing a PST perioperative intervention for older surgical patients at risk of postoperative functional decline, (2) demonstrating the acceptability of the PST intervention and (3) assessing the preliminary impact of the PST intervention on postoperative functional status and depressive symptoms.

The study received ethical approval from the University of California San Francisco Institutional Review Board. Results of this study will be published in peer-reviewed scientific journals with further dissemination at local institutional meetings and professional conferences.

NCT06174701.

Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.

This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.

The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.

ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).

Effective haemorrhage control is crucial in cases of limb trauma involving arterial injury, such as shark attacks, to prevent potentially fatal outcomes. International first aid consensus recommends the use of arterial tourniquets (proprietary or makeshift) as a primary treatment for life-threatening external bleeding. Manual pressure applied directly over a major artery proximal to the injury, such as inguinal fist compression (IFC), is more accessible in a first-aid situation, but is currently not recommended due to limited evidence. The purpose of this study is to determine whether the application of IFC is superior to commercial windlass tourniquets (CWTs) in reducing blood flow in the femoral artery when performed by untrained bystanders.

Stopping Haemorrhage by Application of Randomised Compression or Tourniquet (SHARC-2) is a superiority, assessor-blinded, cross-over, randomised controlled trial conducted with healthy untrained adult volunteers in non-clinical settings. Participants will be rotated as providers and recipients of both IFC and CWT, with providers randomised to the order that they perform the techniques. Providers will be exposed to an educational infographic before applying that technique to a recipient behind a drop sheet. A sonographer, blinded to the technique, will measure the peak systolic velocity of blood flow in the superficial femoral artery using Doppler ultrasound at baseline and then during application of each technique for 5 min. The mean percentage reduction in peak systolic velocity will be compared between IFC and CWT groups.

Ethics approval for this study was granted by the Bond University Human Research Ethics Committee (BUHREC JF01036) on 23 January 2023. All participants will be provided with written informed consent prior to enrolment and the trial will involve healthy adult volunteers. To minimise risk, preintervention screening, sonographic assessment and postintervention follow-up will be implemented with adverse events monitored and reported in accordance with HREC guidelines. Results will be disseminated through peer-reviewed journals, academic conferences, local resuscitation forums and public health education initiatives. A lay summary will also be shared with relevant community groups and via social media platforms to enhance public accessibility.

ACTRN12624001054505.

There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.