Advanced fibrosis (≥F3) from metabolic dysfunction–associated steatotic liver disease (MASLD) is commonly under-detected in primary care. Given the significant cognitive burden and time constraints already faced by primary care providers, clinical workflow integration is a major hurdle for introducing new diagnostic tools. AI-assisted decision-support tools hold significant promise for overcoming this barrier by seamlessly introducing new diagnostics into the existing practice setting. FibroX, an explainable artificial intelligence (AI) decision-support tool, uses routinely available clinical data to predict the risk of advanced fibrosis. It presents a unique opportunity to close the liver fibrosis ≥F3 under-diagnosis gap in primary care. It accomplishes this by operationalizing dual-threshold triage and providing Shapley additive explanations to support both trust and actionability among clinicians. Real-world application suggests FibroX not only outperforms the standard FIB-4 score but is also prognostic for long-term mortality. However, its feasibility and impact within existing clinical workflows remain untested. As a result, we will investigate these critical parameters in a multi-site, provider-level, randomized crossover simulation pilot. This 12-month pilot will recruit up to 40 primary care clinicians from 4 to 6 clinics. Each clinician will complete two periods after allocation to an AB or a BA sequence where A is FibroX and B is usual care (standard labs ± link to FIB-4). Each provider will diagnose 16 simulated MASLD-risk cases per period separated by a 1-week washout period. Ground truth fibrosis stage for cases will be derived from biopsy or vibration controlled transient elastography-based expert consensus. Primary feasibility will aim for recruitment ≥70
Multiple myeloma (MM) is an incurable plasma cell malignancy with relapses and diminishing response durations. Preclinical studies suggest that time-restricted eating (TRE)-related metabolic changes may enhance chemosensitivity by exploiting cancer cell vulnerabilities to nutrient deprivation. Clinical data in solid tumours remain limited and heterogeneous, mainly supporting feasibility and possible toxicity reduction rather than definitive efficacy. While efficacy has been explored in breast cancer patients, there is a lack of data for haematological patients, including MM. FASTINA (Fasting in Staging of MM – Intervention for Nutritional Adherence) will therefore primarily assess feasibility and safety and will explore preliminary efficacy of incorporating TRE into standard MM therapy. FASTINA is a single-centre, open-label, parallel-group randomised controlled feasibility trial (DRKS00034370). 54 adults with MM will be randomised 1:1 to either 16:8 TRE + nutritional counselling or nutritional counselling alone for 12 weeks during systemic therapy. Primary endpoints are adherence to the diet (adherence ≥ 80 https://drks.de/search/de/trial/DRKS00034370 .
People with severe mental illness demonstrate markedly reduced life expectancy, largely due to preventable cardiometabolic disease. This burden is particularly pronounced in compulsory forensic psychiatric care, where prolonged inpatient stays, restrictive environments, and long-term antipsychotic treatment contribute to high levels of sedentary behavior, unhealthy diet, tobacco use, and metabolic disturbances. Despite substantial cardiometabolic risk, individuals in forensic psychiatric settings are frequently excluded from preventive health research, resulting in limited evidence regarding the feasibility and acceptability of lifestyle interventions in this context. Recent international recommendations emphasize the need to integrate structured lifestyle interventions as core components of mental healthcare, including in secure and compulsory settings. The FOR-HEALTH study aims to assess the feasibility and acceptability of an adapted Structured Health Dialogue intervention delivered in compulsory forensic psychiatric inpatient care. Secondary objectives are to describe cardiometabolic, lifestyle, and patient-reported outcomes to inform the design of a future definitive randomized controlled trial. This randomized controlled feasibility trial evaluates an adapted version of Structured Health Dialogues, an evidence-based cardiovascular prevention model originally developed for Swedish primary care. Participants are randomized in a 1:1 ratio to receive either Structured Health Dialogues plus treatment as usual or treatment as usual alone. Structured Health Dialogues integrate a systematic assessment of lifestyle behaviors, biological risk markers, psychosocial stress, and heredity into an individualized visual risk profile, which forms the basis for a motivational, person-centered dialogue. The intervention is adapted to the forensic psychiatric context and delivered within a secure inpatient setting. Primary outcomes relate to feasibility, including recruitment, retention, intervention delivery, and acceptability. Secondary outcomes include exploratory changes in lifestyle behaviors, cardiometabolic risk markers, and patient-reported outcomes. A total of 50 participants (25 per group) will be recruited. The study has been approved by the Swedish Ethical Review Authority. The findings are expected to inform the design and implementation of a future definitive randomized controlled trial evaluating Structured Health Dialogues in forensic psychiatric inpatient care. NCT07157813.
Periprosthetic joint infection (PJI) remains difficult to diagnose due to the limited sensitivity of conventional culture, which frequently yields false-negative results. Targeted amplicon next-generation sequencing (tNGS) offers a method capable of identifying fastidious organisms, polymicrobial infections, and antimicrobial resistance genes. This pilot proof-of-concept study evaluated the feasibility of applying tNGS to sonicated fluid from orthopedic implants compared with conventional culture. Six sonicated fluid samples were collected from patients undergoing revision arthroplasty or removal of osteosynthesis devices between August and September 2024. Implants were processed in saline or Ringer’s lactate and subjected to a standardized sonication protocol, followed by aerobic and anaerobic culture. Parallel tNGS analysis targeted bacterial 16S rRNA and fungal internal transcribed spacer regions, sequenced on an Illumina MiSeq platform with bioinformatic quality control and contaminant filtering. Microbial identifications and predicted resistance genes were compared descriptively across methods. Patients ranged in age from 23 to 76 years; comorbidities included diabetes, dyslipidemia, and hypertension. Conventional culture identified pathogens in four of six cases but missed fungi, several bacterial species, and resistance markers. In contrast, NGS successfully processed all six sonicated fluid samples, confirming the technical feasibility of the approach while confirming culture-positive organisms such as Staphylococcus aureus and detecting additional clinically relevant bacteria, fungi (Cladosporium, Rhodotorula), and resistance genes (mecA, aph3′) that culture failed to identify. Two samples were negative by both methods. Discrepancies were more frequent in samples processed with Ringer’s lactate, suggesting interference with sequencing. This pilot study demonstrated the feasibility of applying targeted amplicon next-generation sequencing to sonicated fluid from orthopedic implants and highlighted its potential to complement conventional culture by identifying fastidious organisms, polymicrobial infections, and resistance determinants. These findings highlight its potential to improve diagnostic accuracy and guide personalized antimicrobial therapy in PJI. Although the small sample size and descriptive design limit generalizability, pilot study provides early evidence supporting the feasibility of applying tNGS to sonicated fluid and identifies methodological considerations for future research. Larger prospective trials are warranted to validate these results and establish NGS as an adjunct or alternative to culture in orthopedic infection diagnostics. The study protocol was approved by the local Institutional Review Board (CAAE: 46277421.1.0000.5479; approval number: 4.713.409).
The primary aim of the SAMADI [SAponins for MAcular DIsease] trial is to establish whether treatment of age-related macular degeneration (AMD) with oral saponin supplements is feasible and acceptable to participants. AMD is a progressive disease, which results in the death and dysfunction of cells in the outer retina. One potential contributor to AMD progression is the reduced permeability of Bruch’s membrane underlying the retina. Saponins have a structure enabling them to assist dispersal of lipid deposits in Bruch’s membrane, providing a rationale for the proposed intervention in AMD. Secondary aims are to provide an estimate of the variability of a proposed future primary outcome, and to provide estimates of treatment effects of clinical outcomes. SAMADI is a double masked randomised feasibility trial, which will recruit 60 participants with early or intermediate AMD in at least one eye. Participants will be randomly assigned into one of two groups, one receiving the oral saponin tablets and the other placebo tablets (indistinguishable in appearance), both to be taken daily for 4 months. Participants and research optometrists will be masked to the allocation. Clinical tests will be repeated at baseline, 4 months and 12 months. The primary outcome measures relate to feasibility of the following aspects of the intervention and study design: (1) recruitment and retention over 4 and 12 months; (2) adherence to treatment and acceptability of intervention; (3) the eligibility assessment process; (4) collecting the outcome data. The rate of serious adverse events will be an additional primary outcome measure. Secondary outcomes include dark adaptation metrics, best corrected visual acuity, contrast sensitivity, fundus imaging, low luminance questionnaire, standard electroretinograms according to International Society for Clinical Electrophysiology of Vision standard protocols, and imaging retinal densitometry (at one site only). The data will be used to determine the feasibility of the trial design, how well participants complied with taking the tablets, and the potential effectiveness of the treatment. If feasible, this information will be used to inform a larger trial, which will definitively assess how effective the treatment is in participants with AMD. The trial is registered with EudraCT and ISRCTN registries. EudraCT ref: 2021–003045-38; Date of registration: 24/05/2021. ISRCTN ref: ISRCTN82949875; Date of registration: July 21, 2021. URL: https://www.isrctn.com/ISRCTN82949875. Version and date: This report is based on Protocol V3, January 2024. Sponsor: Cardiff University, Research Governance Team, Research and Innovation Services, Cardiff University, 7th Floor, McKenzie House, 30–36 Newport Road, Cardiff CF24 0DE.
Stroke is the second leading non-communicable cause of death and third leading cause of death and disability worldwide with prevalence expected to rise 120
Readiness for change (R4C) is an important antecedent of care practice change and is linked to a range of implementation and effectiveness outcomes. We describe the creation, piloting, and evaluation of R4C activities intended to help nursing home (NH) teams implement a quality improvement intervention. We developed and operationalized an R4C module with activities conducted with NH leaders during intervention recruitment. An implementation pilot was conducted in three NHs and evaluated using a mixed-methods process evaluation guided by Proctor’s (2011) implementation outcomes framework. R4C activities were feasible, acceptable, and delivered with fidelity. The approach promoted readiness among senior leaders, but not among front-line teams. Results also showed (1) R4C activities are closely tied to other variables (e.g. NH leadership facilitation) that influence implementation, and (2) core R4C components (i.e. change efficacy) can emerge during an intervention, pending teams’ perceived success. We suggest conducting R4C activities with all of those involved across an organization who have a role to play in change implementation. Findings also reveal challenges associated with isolating the effects of “pre-intervention” R4C activities on intervention implementation and success. Pilot results will inform a larger-scale quality improvement study.
People diagnosed with severe mental illness (SMI) die around 15–20 years prematurely compared with people without these conditions, partially to a 50
Needle fear affects up to half of all young people, with the potential to impede their accessing and acceptance of healthcare interventions. There is presently a lack of accessible self-help resources available to support young people in managing needle-based procedures. This feasibility study aims to create a trial protocol for future definitive assessment of a self-help tool co-designed with young people, to manage their fear of needles. This article presents the protocol for a study to evaluate the feasibility of a future definitive randomised trial, and broad acceptability of a developed self-help resource. In total sixty children aged 11–16 years will be recruited from across three sites (secondary dental care, secondary medical care and a school setting) and directed to complete the proposed outcome measures and access a self-help resource developed by the authors in collaboration with young people, parents and healthcare professionals in order to test feasibility. Additionally, a subset of 20 children will be invited to participate in qualitative interviews following their involvement in the feasibility phase to explore their experiences, any key facilitators or barriers, and their general acceptance of the resource. This study will address key uncertainties around recruitment of sites and participants, and variability of outcome measures, prior to a definitive future trial. The resource was developed in collaboration with young people, parents and healthcare professionals. This self-help resource has the long-term potential to benefit young people through support in managing their fear of needles. This study will provide methodological evidence to support a future definitive trial evaluating the effectiveness of the resource.
Conventional stroke rehabilitation often suffers from low adherence due to its monotonous nature. Although serious games offer an engaging alternative, their feasibility in resource-limited settings in developing countries remains underexplored. This study evaluates the acceptance of an adaptive serious game system among stroke survivors in Iran. A cross-sectional feasibility study investigated the potential of using exercise games for stroke rehabilitation in an Iranian clinical setting. The intervention employed a custom-developed adaptive system featuring four adjustable-level exercise games designed to target upper-limb motor function. The system included a calibration feature to tailor the range of motion (ROM) to the capabilities of each stroke survivor. Participants evaluated the system using a structured questionnaire based on the Technology Acceptance Model (TAM), assessing perceived usefulness, attitude, perceived ease of use, and intention to use. Ten participants with chronic stroke (8 males, 2 females; mean age = 60 ± 14.34 years) with a mean baseline FMA-UE score of 42.50 ± 6.80 participated in supervised sessions. Participants reported high perceived usefulness (0.83) and a positive attitude (0.87), indicating that the system was considered beneficial for rehabilitation. However, perceived ease of use (0.67) and intention to use (0.64) were moderate, likely reflecting the learning curve associated with digital technology in this demographic. Importantly, the adaptive calibration minimized pain and enhanced engagement. The adaptive serious gaming system demonstrates feasibility and high levels of engagement and satisfaction for upper-limb rehabilitation in stroke survivors in a developing country context. Participants found the games comprehensible, easy to use, useful, and enjoyable, suggesting that tailored technological interventions can be successfully implemented in this healthcare setting.
Ductal dependent congenital heart disease (ddCHD) is associated with significant parental anxiety, yet palliative care (PC) support is rarely offered in the prenatal period. While prior studies have evaluated PC postnatally, little is known about feasibility and acceptability of prenatal PC interventions for this population. The purpose of this study is to assess feasibility and acceptability of prenatal PC support sessions (PCSS) for parents whose fetus has been diagnosed with ddCHD requiring neonatal cardiac intervention. This prospective single-center feasibility study enrolled English-speaking parents referred to a pediatric cardiology clinic after fetal echocardiographic diagnosis of ddCHD. Eligible participants were offered monthly prenatal PCSS, in person or via videoconference, led by a dual-certified pediatric critical care and hospice/palliative medicine physician. Feasibility was defined as ≥75
Group mindfulness-based cognitive therapy (MBCT) is recommended for the treatment of subthreshold-to-mild depressive symptoms. Timely access to MBCT, however, is limited by accessibility issues. Self-help MBCT can overcome these issues, but is associated with poorer engagement. Incorporating virtual reality into self-help MBCT (VR-MBCT) may improve engagement, but relatively little is known about its feasibility and acceptability. Consequently, the aims of this study were to examine the acceptability, feasibility and preliminary signals of efficacy of VR-MBCT for reducing psychological distress in people with depression and/or anxiety symptoms. In two uncontrolled feasibility studies, participants aged ≥ 18 years with mild-to-moderately severe symptoms of depression and/or anxiety were recruited via self-referral. Participants received five VR-MBCT sessions (totalling approximately two hours in duration) each week for 8 weeks plus usual care. Co-primary outcomes were feasibility (recruitment, retention and data completion) and acceptability (course completion and satisfaction with VR-MBCT) in both studies. Secondary outcomes included measures of depression, anxiety, mental well-being and mindfulness, assessed at pre- and post-intervention. In Study 1, 35 participants (100
Myotonic dystrophy type 1 (DM1) is a rare autosomal dominant inherited multi-systemic disease affecting neuromuscular, cognitive, and cardiac function. Congenital DM1 (CDM) is the most severe form of the disease and is associated with learning difficulties, autism-like traits, and cardiac conduction defects. There is no approved pharmacological therapy for CDM. While music interventions have been shown to positively impact children with similar brain and heart symptoms, like cerebral palsy and autism, this type of non-pharmacological intervention has not been tested in CDM. Therefore, this convergent mixed-methods study will assess the tolerability and feasibility of a 10-week music and movement intervention for children with CDM. Participants will be recruited from the pediatric neuromuscular clinic at the Children’s Hospital of Eastern Ontario (CHEO). In a dyad participation model, parents of participants will also engage to inform the overall feasibility. There will be two groups with 6–8 participants each. Group allocation will not be randomized but will be based on age and physical and mental ability. A baseline visit will be followed by a 10-week intervention phase with one music and movement intervention session per week. Sessions will include physical assessments and questionnaires. The primary outcome is the feasibility and tolerability of these music interventions. Secondary outcome measures include cognitive and physical assessments, as well as measures of quality of life, sleep quality, and biomarkers. This study will demonstrate the feasibility and tolerability of music and movement intervention for pediatric participants with CDM, while providing an indication of its impacts on brain and heart function for this multi-system disease. Results from this study will inform the implementation of a larger-scale trial as well as the development of other non-pharmacological feasibility studies in this population. Clinicaltrials.gov number: NCT06809049. Registered 30 Jan 2025. https://clinicaltrials.gov/study/NCT06809049?id=NCT06809049 rank=1.
Calcium–oxalate (CaOx) nephrolithiasis is a common form of kidney stone disease (KSD) with potential progression to chronic kidney disease (CKD). Genetic factors, including variants in the SLC13A2 gene encoding the NaDC-1 citrate transporter, may modulate individual susceptibility. This pilot cross-sectional study evaluated the feasibility of implementing standardized genotyping and phenotype assessment workflows in CaOx nephrolithiasis patients to explore genotype-kidney function associations. Eighty adult patients with radiologically confirmed CaOx KSD were recruited from a tertiary care center in Kyiv, Ukraine (2024). Exclusion criteria included primary hyperoxaluria, secondary stone disease, and glomerular pathology. Genotyping for the SLC13A2 rs11567842 variant in peripheral blood DNA was performed using polymerase chain reaction followed by restriction fragment length analysis. Clinical and laboratory data were collected, including plasma oxalate concentration and estimated glomerular filtration rate (eGFR). Statistical analyses, including chi-square tests, Mann–Whitney tests, Kruskal–Wallis tests, and exploratory logistic regression (univariate and multivariable), were performed to evaluate the association between SLC13A2 rs11567842 genotypes and reduced kidney function (eGFR < 60 mL/min/1.73 m2). Of the cohort (62.5
Most new parents will experience changes to their sexual relationship during the perinatal period, yet no accessible prevention programs exist to support couples in navigating these changes. Our aim was to assess the feasibility of the introductory modules of an online couple-based program (STORK) designed to promote perinatal sexual well-being. The program is grounded in empirically established risk and protective factors associated with couples’ perinatal sexual well-being. We conducted a single-group feasibility study with eleven couples (22 individuals) expecting their first child (mean gestation 20 weeks). Couples completed the orientation and first STORK modules during a 2-h online session with a researcher. Participants then completed an online survey evaluating the program’s feasibility and content. Qualitative semi-structured interviews and online questionnaires assessed participants’ experiences with the platform, focusing on usability, acceptability, clarity, relevance, and overall satisfaction. Participants reported high acceptability, rating both modules as clear and logical (mean = 5.6–5.9/7), enjoyable (mean = 4.7–6.1/7), helpful (mean = 5.0–5.7/7), and relevant (mean = 6.1/7). The platform was rated as easy to navigate (mean = 5.6/7) and highly inclusive (mean = 6.0–6.1/7). Most participants found the time commitment reasonable (95.5
Exercise is a first-line treatment for women with polycystic ovary syndrome (PCOS). However, research findings reveal that women with PCOS report low exercise motivation due to PCOS stigma-related stress and lack of social connection, inhibiting exercise in public and group settings. The purpose of this study was to assess the feasibility and acceptability of an in-home resistance exercise program supervised in real time by personal trainers using smart home video devices (SHVDs) with peer support through a buddy system. This one-arm feasibility study incorporated strategies from self-determination theory to meet participants’ psychological needs of autonomy, competence, and relatedness. Participants (N = 10) received an SHVD and exercise equipment (bands, stability ball). Personal trainers supervised 2 individual RE sessions per week for 12 weeks per participant via the SHVD’s video feature. Participants were randomly paired with a buddy and encouraged to connect weekly for peer support. Feasibility, acceptability, depressive symptoms, anthropometrics, and muscular endurance were measured using surveys, fitness testing, and interviews. Quantitative data were analyzed using t-tests. Qualitative data were analyzed via thematic analysis. Participants were 26.6 (8.8) years, mostly White (70
Evidence on the effectiveness of electromyostimulation (EMS) has been reported in pulmonary rehabilitation, but the benefits have been limited in chronic obstructive pulmonary disease, and clinical trials in advanced idiopathic pulmonary fibrosis were not considered feasible. Recently, whole-body EMS (WB-EMS) has been developed and applied in the area of non-medical commercial application. To date, there are no reports on the application of medical WB-EMS for respiratory diseases. The aim of this study is to investigate the feasibility and acceptability of WB-EMS as an adjunct to pulmonary rehabilitation in patients with chronic respiratory disease. This is a protocol for a pilot, single group, feasibility trial. The e-skin is an EMS suit that can simultaneously load the muscles of the entire body (Xenoma Inc., Tokyo, Japan). Participants will conduct one session per day, once a week for 4 weeks. They perform resistance exercise trainings during EMS under the supervision and guidance of a trained physiotherapist or respiratory physician as a trainer. A physiotherapist controls the HUB attached to the suit with a dedicated mobile application. Each setting of EMS is determined by each segment of electrical stimulation and meets the recommended regimen and guideline criteria for WB-EMS operation. Outcome measures will include Modified Medical Research Council Dyspnoea Scale, pulmonary function test, health-related quality of life, exercise tests including six-minute walk test and one-minute sit-to-stand-test, Barthel Index, muscle strength, body composition analysis, and blood tests such as muscle markers and renal function markers. To assess the feasibility and acceptability of the intervention, participant adherence, retention, and perceived burden will be evaluated. WB-EMS can stimulate both type I and type II muscle fibers and may help counteract preferential type II fiber atrophy frequently observed in CRD. This pilot study focuses on verifying the feasibility and acceptability of WB-EMS as an adjunct to pulmonary rehabilitation. By providing a physiologically distinct, time-efficient training modality that minimizes cardiopulmonary load, WB-EMS could become a promising rehabilitation option for patients with limited exercise tolerance. UMIN-CTR, UMIN000057270. Retrospectively registered 12 March 2025.
Orthostatic hypotension (OH) is a common cause of falls, and key source of morbidity and mortality due to injury (e.g. hip fracture). Current guidelines recommend increasing salt intake in patients with symptomatic orthostatic hypotension. However, the evidence underpinning this recommendation is poor, based primarily on small trials with very short-term follow-up (<8 weeks). High salt intake might improve quality of life and reduce the risk of falls, but might also increase the long-term risk of cardiovascular disease, in patients with OH. STOOD is a two-group, parallel, open-label, randomised controlled, single centre trial. Adults aged ≥65 years with symptomatic orthostatic hypotension, and estimated moderate salt intake (based on screening questions) will be eligible. Exclusion criteria include uncontrolled hypertension (>180/110 mmHg), heart failure (NYHA class III/IV, or ejection fraction < 30
Cognitive decline is common after cardiac surgery and is associated with poor postoperative outcomes. The aim of this study was to evaluate the feasibility and acceptability of a home-based computerised cognitive training programme to improve POCD following cardiac surgery; this study was not designed to assess the efficacy of the intervention. This single-arm, non-blinded, feasibility and acceptability study included patients ≥ 18 years undergoing first-time elective cardiac surgery using standard extracorporeal circulation. Participants were required to complete an 8-week computerised cognitive training (CCT) programme (20 min/day; 5 days/week), commencing 1 week after surgery. The Montreal Cognitive Assessment (MoCA) was administered preoperatively and after programme completion. Feasibility outcomes included recruitment and retention rates and programme adherence. Acceptability was assessed by the Theoretical Framework of Acceptability Questionnaire (TFA-Q). Twenty-nine participants were recruited: 7 (24
