Feasibility of in-home monitoring for people with glaucoma: the I-TRAC mixed-methods study.

Background: Glaucoma is a chronic disease of the optic nerve and a leading cause of severe visual loss in the UK. Once patients have been diagnosed, they need regular monitoring at hospital eye services. Recent advances in technology mean patients with glaucoma can now monitor their disease at home. This could be more convenient for patients and potentially reduce costs and increase capacity for the NHS. However, it is uncertain whether self-monitoring would be acceptable or possible for patients with glaucoma. Objectives: The objectives were to: identify which patients are most appropriate for home monitoring; understand views of key stakeholders (patients, clinicians, researchers) on whether home glaucoma monitoring is feasible and acceptable; develop a conceptual framework for the economic evaluation of home glaucoma monitoring; and explore the need for and provide evidence on the design of a future study to evaluate the clinical and cost-effectiveness of digital technologies for home monitoring of glaucoma. Design: In-home Tracking of glaucoma: Reliability, Acceptability, and Cost (I-TRAC) was a multiphase mixed-methods feasibility study with key components informed by theoretical and conceptual frameworks. Setting: Expert glaucoma specialists in the UK recruited through professional glaucoma societies; study site staff and patient participants recruited through three UK hospital eye services (England, Scotland, Northern Ireland); and UK research teams recruited though existing networks. Intervention: Home tonometer that measures intraocular pressure and a tablet computer with a visual function application. Patients were asked to use the technology weekly for 12 weeks. Results: Forty-two patients were recruited. Retention and completion of follow-up procedures was successful, with 95% (n = 40) completing the 3-month follow-up clinic visits. Adherence to the interventions was generally high [adherence to both devices (i.e. ≥ 80% adherence) was 55%]. Overall, patients and healthcare professionals were cautiously optimistic about the acceptability of digital technologies for home monitoring of patients with glaucoma. While most clinicians were supportive of the potential advantages glaucoma home monitoring could offer, concerns about the technologies (e.g. reliability and potential to miss disease progression) and how they would fit into routine care need to be addressed. Additionally, clarity is required on defining the ideal population for this intervention. Plans for how to evaluate value for money in a future study were also identified. However, the study also highlighted several unknowns relating to core components of a future evaluative study that require addressing before progression to a definitive effectiveness trial. Limitations: The main limitation relates to our sample and its generalisability, for example, the over-representation of educated persons of white ethnicity who were generally experienced with technology and research motivated. Conclusions: The In-home Tracking of glaucoma: Reliability, Acceptability, and Cost study has demonstrated 'cautious optimism' when considering patients' and healthcare professionals' views on the acceptability of digital technologies for home monitoring of patients with glaucoma. However, the study also highlighted several unknowns relating to the research question and design of a future evaluative study that require addressing before progression to a randomised controlled trial. Future work: Further research is required to determine the appropriate population (i.e. low vs. high risk of progression) and further refine the intervention components and delivery for planning of future evaluation studies. Study registration: This study is registered as Research Registry #6213. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR129248) and is published in full in Health Technology Assessment; Vol. 28, No. 44. See the NIHR Funding and Awards website for further award information.

The In-home Tracking of glaucoma: Reliability, Acceptability, and Cost study explored whether glaucoma patients who would normally be monitored in hospital could do some monitoring themselves at home, and whether self-monitoring at home would be acceptable or possible for them. We delivered In-home Tracking of glaucoma: Reliability, Acceptability, and Cost in four phases by: Surveying expert glaucoma specialists to understand which patients would benefit most from home monitoring. Providing glaucoma patients with an iPad tablet and a device which measures eye pressure to use once a week for 3 months. The patients who participated and the clinical staff delivering the study were interviewed about their experiences. Interviewing researchers with experience of running large studies testing digital technologies to monitor patients' health at home to understand challenges. Reviewing other researchers' work and comparing it with ours to help us understand whether home monitoring of glaucoma could be good value for money. Overall, patients and healthcare professionals were cautiously optimistic about the digital technologies for home monitoring of glaucoma. Most patient participants were able to use the technologies, and half told us they preferred home monitoring. Most clinicians recognised the potential advantages of glaucoma home monitoring but had concerns about the technologies (specifically reliability and the risk of missing disease progression) and how they would fit into routine care. Plans for how to evaluate value for money in a future study were identified. The study did not aim to identify whether the digital technology was better than what happens currently; a different study design with many more patients would be required to answer that question. The study did identify several important questions to answer before designing a future larger study; for example, how to ensure diverse patient participation. These questions should be the focus of future research in this area.

Prehabilitation for frail patients undergoing hip and knee replacement in the UK: Joint PREP feasibility study for a randomised controlled trial.

OBJECTIVE: To determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR). DESIGN: Randomised feasibility study with embedded qualitative work. SETTING: Three National Health Service hospitals. PARTICIPANTS: Adults aged ≥65 years, frail and scheduled for primary THR or TKR. INTERVENTION: Appointment with a physiotherapist to individualise a home-based exercise programme. Participants were encouraged to do the home exercises daily for 12 weeks pre-operative and were provided with a daily protein supplement. Participants were supported by six telephone calls over the 12-week intervention period. OUTCOME MEASURES: Eligibility and recruitment rates, intervention adherence, data completion rates of patient-reported outcome measures, retention rates and acceptability of the trial and intervention. Qualitative interviews were conducted with participants and non-participants and analysed using thematic analysis. RESULTS: Between December 2022 and August 2023, 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants (73%) completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% (55/64 overall) at 12 weeks. The 12-week follow-up questionnaire was returned by 46 of the 55 participants (84%) who were sent a questionnaire. Interviews with 19 patients found that the trial processes and intervention were generally acceptable, but areas of potential improvements were identified. CONCLUSIONS: This study demonstrated that a larger study is possible and has identified improvements to optimise the design of an RCT. TRIAL REGISTRATION NUMBER: ISRCTN11121506.

Using autologous umbilical cord blood and placental cells for hypoxic-ischemic encephalopathy: an exploratory safety and feasibility study. / Células autólogas de sangre de cordón umbilical y placenta para la encefalopatía hipóxico isquémica: estudio exploratorio de seguridad y factibilidad.

Introduction. Hypoxic-ischemic encephalopathy (HIE) caused by lack of oxygen and perfusion to the brain can lead to acute neurological damage in newborns. Therapeutic hypothermia (TH) is the most effective and safest treatment. However, mortality remains high with numerous long-term sequelae. Cellular therapies, particularly umbilical cord blood (UCB), are being studied as alternative therapies. The aim of this study is to assess the feasibility and safety of combining autologous cord blood cell infusion with moderate hypothermia. Population and methods. Twelve infants of 36 weeks gestational age or older, diagnosed with moderate or severe HIE and with umbilical cord blood (UCB) collected were included. UCB was volume-reduced, and up to four doses were obtained. These doses were infused within the first 72 postnatal hours. Time to the first infusion and possible adverse reactions to the infusion were evaluated. Results. Between 2014 and 2019, 12 infants were included in the protocol (TH + UCB), 9 with a diagnosis of moderate HIE and 3 with severe HIE. In all cases, at least one dose of UCB was obtained for infusion. In all cases, the first dose was infused within 24 hours in every case, and no adverse reactions attributable to the infusion were observed. Conclusions. The collection, processing, and infusion of fresh autologous umbilical cord blood for use in newborns with HIE are feasible and safe under our conditions.

Introducción. La encefalopatía hipóxico-isquémica (EHI) causada por la falta de oxígeno y/o perfusión al cerebro puede provocar daño neurológico agudo en el recién nacido. La hipotermia terapéutica (HT) es el tratamiento más eficaz y seguro. Sin embargo, la mortalidad sigue siendo alta y con numerosas secuelas a largo plazo. Las terapias celulares y, en particular, la sangre de cordón umbilical (SCU) se estudian como terapias alternativas. El objetivo de este trabajo es evaluar la factibilidad y seguridad de la infusión de células autólogas de la sangre de cordón junto con la hipotermia moderada. Población y métodos. Se incorporaron 12 bebés de 36 semanas o más de gestación con diagnóstico de EHI moderada o grave y que contaban con colecta de SCU. La SCU se redujo en volumen y se obtuvieron hasta 4 dosis, que fueron infundidas en las primeras 72 horas posnatales. Se evaluó el tiempo a la primera infusión y posibles reacciones adversas a la infusión. Resultados. Entre los años 2014 y 2019, 12 bebés fueron incluidos en el protocolo (HT + SCU), 9 con diagnóstico de EHI moderada y 3 con EHI grave. En todos los casos, se obtuvo al menos 1 dosis de SCU para infundir. En todos los casos, fue posible infundir la primera dosis antes de las 24 horas y no hubo reacciones adversas atribuibles a la infusión. Conclusiones. La colecta, preparación e infusión de sangre de cordón umbilical autóloga fresca para su uso en recién nacidos con EHI es factible y segura en nuestras condiciones.

Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial.

Background: Transcranial temporal interference stimulation (tTIS) is a new, emerging neurostimulation technology that utilizes two or more electric fields at specific frequencies to modulate the oscillations of neurons at a desired spatial location in the brain. The physics of tTIS offers the advantage of modulating deep brain structures in a non-invasive fashion and with minimal stimulation of the overlying cortex outside of a selected target. As such, tTIS can be effectively employed in the context of therapeutics for the psychiatric disease of disrupted brain connectivity, such as major depressive disorder (MDD). The subgenual anterior cingulate cortex (sgACC), a key brain center that regulates human emotions and influences negative emotional states, is a plausible target for tTIS in MDD based on reports of its successful neuromodulation with invasive deep brain stimulation. Methods: This pilot, single-site, double-blind, randomized, sham-controlled interventional clinical trial will be conducted at St. Michael's Hospital - Unity Health Toronto in Toronto, ON, Canada. The primary objective is to demonstrate target engagement of the sgACC with 130 Hz tTIS using resting-state magnetic resonance imaging (MRI) techniques. The secondary objective is to estimate the therapeutic potential of tTIS for MDD by evaluating the change in clinical characteristics of participants and electrophysiological outcomes and providing feasibility and tolerability estimates for a large-scale efficacy trial. Thirty participants (18-65 years) with unipolar, non-psychotic MDD will be recruited and randomized to receive 10 sessions of 130 Hz tTIS or sham stimulation (n = 15 per arm). The trial includes a pre- vs. post-treatment 3T MRI scan of the brain, clinical evaluation, and electroencephalography (EEG) acquisition at rest and during the auditory mismatch negativity (MMN) paradigm. Discussion: This study is one of the first-ever clinical trials among patients with psychiatric disorders examining the therapeutic potential of repetitive tTIS and its neurobiological mechanisms. Data obtained from this trial will be used to optimize the tTIS approach and design a large-scale efficacy trial. Research in this area has the potential to provide a novel treatment option for individuals with MDD and circuitry-related disorders and may contribute to the process of obtaining regulatory approval for therapeutic applications of tTIS. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05295888.

A multicenter retrospective study to assess feasibility, safety and efficacy of first-line carboplatin-paclitaxel versus carboplatin monotherapy in a frail, elderly epithelial ovarian cancer population.

OBJECTIVE: Underrepresentation of elderly ovarian cancer patients in clinical trials has led to lack of clarity regarding optimal first-line chemotherapy in this cohort. The Elderly Women with Ovarian Cancer (EWOC)-1 trial demonstrated that 3-weekly carboplatin (3wC) resulted in worse survival and feasibility compared with standard 3-weekly carboplatin-paclitaxel (3wCP) in frail, elderly ovarian cancer patients. Our retrospective study compares feasibility, safety, and efficacy of first-line 3wCP and 3wC in a frail ovarian cancer cohort. METHODS: Clinical data were retrospectively analyzed for newly-diagnosed, International Federation of Gynecology and Obstetrics (FIGO) stage III/IV, ≥70-year-old epithelial ovarian cancer patients, treated by clinician choice with 3wC or 3wCP at two London cancer centers over a 2 year period. Charlson Comorbidity Index (CCI) and Eastern Cooperative Oncology Group (ECOG) performance status provided surrogate markers of frailty. Common Terminology Criteria for Adverse Events v5.0 graded toxicity. RESULTS: A total of 107 patients were treated with 3wC (n=30) and 3wCP (n=77). Age, performance status, and CCI were significantly different between cohorts, with 3wC patients older (84 vs 75 years, p<0.001), with more comorbidities (median CCI 4 vs 3, p<0.001) and worse performance status (47% vs 17% PS ≥2, p=0.015). Surgical outcomes differed significantly between cohorts, with 20 (67%) 3wC patients not undergoing surgery, compared with 22 (29%) 3wCP patients (p<0.001). Median follow-up was 45.8 months (IQR 38.7-56.3 months). While we observed improved progression-free (HR 0.55, 95% CI 0.33 to 0.90, p=0.017) and overall survival (HR 0.44, 95% CI 0.27 to 0.73, p=0.001, log-rank test) in a univariate cox proportional hazards comparison between 3wCP and 3wC, this was not significant on multivariate analysis. Completion of six planned chemotherapy cycles was achieved by the majority, with similar discontinuation rates between groups (13% 3wC vs 8% 3wCP, p>0.05). Overall grade ≥3 hematological toxicity rates were similar between regimens (33% 3wC vs 44% 3wCP, p=0.37) with grade ≥3 neutropenia (p=0.019) and grade ≥3 thrombocytopenia (p=0.006) more common with 3wCP and 3wC, respectively. No treatment-related deaths occurred. CONCLUSION: Our data demonstrates that standard 3wCP is a well-tolerated, feasible first-line treatment for frail, elderly ovarian cancer patients. Improved survival with 3wCP was not significant when corrected for established clinical prognostic factors.

Protocol of digital decision support system (DDSS) embedded within a tele-primary healthcare platform in Pakistan: an assessment of usability, acceptability, effectiveness and perceived quality of care in a resource-constrained setting.

BACKGROUND: A digital decision support system in healthcare is a digital health intervention that assists healthcare professionals in decision-making by providing treatment recommendations and enhancing diagnostic accuracy and quality of care. This will be the first study in Pakistan to assess the system's usability, acceptability and effectiveness in improving healthcare outcomes while also evaluating the perceived quality of care. This comprehensive assessment will inform policy development in areas such as the scale-up of digital health interventions, data privacy and technology interoperability. Measures of effectiveness will include changes in clinical outcomes through a patient exit feedback survey. This study aims to evaluate the role of digital decision support systems in healthcare decision-making, which may be integrated into Pakistan's tele-primary healthcare system. METHODS: The study will employ a multimethod approach. The data collection tools are adapted from the WHO's digital health intervention monitoring and evaluation framework and include a technology assessment, healthcare provider surveys, patient exit interviews and focus group discussions with healthcare providers. Purposive sampling will be used for qualitative interviews with providers (doctors) and patients. Government stakeholders, private sectors, multilateral, academia and policymakers will be engaged through a consultative meeting. We will also conduct a literature review, as well as a comprehensive analysis of existing studies, documents and data relevant to digital decision support systems and digital health interventions implemented globally, and assess the performance, challenges and opportunities. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Review Committee at The Aga Khan University (2023-8514-26533). The dissemination of study findings through scientific publications and seminars will enable programme managers and policymakers to design tools to improve the quality of care provided through telemedicine platforms. This will contribute to efficient decision-making, access and quality of care for primary healthcare in low-income and middle-income countries. This study will also inform policy regarding the scale-up of decision support systems in primary care settings, data privacy and technology interoperability.

The Attend-PE model: A feasibility study of a structured follow-up care model for patients with pulmonary embolism.

BACKGROUND: Pulmonary embolism may have both physical and psychological consequences for the affected person. Guidelines recommend structured follow-up care, yet this is still not widely practised. Therefore, a national research project was initiated in Denmark in 2021, with the aim of developing, testing, implementing, and evaluating a structured post-pulmonary embolism follow-up care model, 'Attend-PE'. The objective of this feasibility study was to examine the fidelity, acceptability, and appropriateness of the Attend-PE model in a Danish hospital setting. METHODS: This feasibility study was conducted in two Danish hospitals, using a prospective study design with six months' follow-up. The fidelity, acceptability, and appropriateness of the Attend-PE model's components were evaluated using surveys, registrations sheets, and interviews with two physicians, three nurses, and 29 patients. Qualitative data were analysed using a deductive content analysis, while quantitative data were analysed using descriptive statistics. RESULTS: Fidelity with the Attend-PE model was good, with a high participation rate of patients in all components of the model. Acceptability was likewise good, as both patients and health care professionals expressed a high level of satisfaction with the model. The health care professionals considered the model to be relevant and suitable in a Danish hospital setting, confirming appropriateness of the model. CONCLUSION: This study showed that the Attend-PE model for patients with pulmonary embolism is feasible and acceptable in a Danish hospital setting.

Protocol for a randomised controlled unblinded feasibility trial of HD-DRUM: a rhythmic movement training application for cognitive and motor symptoms in people with Huntington's disease.

INTRODUCTION: Huntington's disease (HD) is an inherited neurodegenerative disease causing progressive cognitive and motor decline, largely due to basal ganglia (BG) atrophy. Rhythmic training offers promise as therapy to counteract BG-regulated deficits. We have developed HD-DRUM, a tablet-based app to enhance movement synchronisation skills and improve cognitive and motor abilities in people with HD. This paper outlines a randomised controlled unblinded trial protocol to determine the feasibility of a larger effectiveness trial for HD-DRUM. Additionally, the trial investigates cognitive and motor function measures, along with brain microstructure, aiming to advance our understanding of the neural mechanisms underlying training effects. METHODS, DESIGN AND ANALYSIS: 50 individuals with HD, confirmed by genetic testing, and a Total Functional Capacity (TFC) score of 9-13, will be recruited into a two-arm randomised controlled feasibility trial. Consenting individuals with HD will be randomised to the intervention group, which entails 8 weeks of at-home usage of HD-DRUM or a usual-activity control group. All participants will undergo cognitive and motor assessments, alongside ultra-strong gradient (300 mT/m) brain microstructural MRI before and after the 8-week period. The feasibility assessment will encompass recruitment, retention, adherence and acceptability of HD-DRUM following prespecified criteria. The study will also evaluate variations in cognitive and motor performance and brain microstructure changes resulting from the intervention to determine effect size estimates for future sample size calculations. ETHICS AND DISSEMINATION: The study has received favourable ethical opinion from the Wales Research Ethics Committee 2 (REC reference: 22/WA/0147) and is sponsored by Cardiff University (SPON1895-22) (Research Integrity, Governance and Ethics Team, Research & Innovation Services, Cardiff University, second Floor, Lakeside Building, University Hospital of Wales, Cardiff, CF14 4XW). Findings will be disseminated to researchers and clinicians in peer-reviewed publications and conference presentations, and to participants, carers and the general public via newsletters and public engagement activities. Data will be shared with the research community via the Enroll-HD platform. TRIAL REGISTRATION NUMBER: ISRCTN11906973.

Psychometric properties and feasibility of three scales assessing the level of knowledge and awareness about pelvic floor health.

OBJECTIVE: Despite high prevalence and burden of pelvic floor dysfunctions (PFD), there is a limited number of scales assessing knowledge of pelvic floor health (PFH), and no studies comparing their psychometric or feasibility properties. The study aimed both to investigate the psychometric properties and feasibility of Incontinence Quiz (IQ), Prolapse and Incontinence Knowledge Questionnaire (PIKQ) and Pelvic Floor Health Knowledge Questionnaire (PFHKQ), and to compare level of PFH knowledge in women with and without PFD. STUDY DESIGN: In this prospective cross-sectional study, a total of 150 women were included. After recording physical-sociodemographic characteristics, obstetric histories and menstrual status, Pelvic Floor Distress Inventory-20 and Female Sexual Function Index were administered to classify them into study groups as women with and without PFD. Their PFH knowledge was assessed using IQ, PIKQ and PFHKQ, which were filled twice with one week interval for the test-retest purpose. The scores, reliability, validity, ceiling-floor effects and feasibility of the knowledge scales were compared with each other, and between the study groups. RESULTS: IQ, PIKQ, and PFHKQ scores of women with and without PFD were similar. Based on response patterns to items, PFHKQ had the highest internal consistency followed by PIKQ and IQ. The PIKQ was the most stable scale across the total sample and in the PFD group. The PFHKQ had the highest ICC value in women without PFD. There was a strong correlation between the total scores of knowledge scales in both groups. Scores of knowledge and symptom scales were not significantly correlated. IQ was completed in the shortest time, and was easier to complete than PFHKQ. Only the diagnosis/treatment subscale of PFHKQ had a ceiling effect. CONCLUSION: It was concluded that PFH knowledge of women with and without PFD were at a low-moderate level and similar to each other; IQ, PIKQ and PFHKQ were reliable, valid and feasible scales, which can be used in measuring knowledge level about PFH.

Use of virtual reality in preoperative education of cardiac surgery patients - A feasibility study.

OBJECTIVE: A Virtual Patient Tour (VPT) was developed to inform cardiac surgery patients about their hospitalization from the admission to their postoperative stay on the ward. The objective of our study was to assess the feasibility and acceptability of this VPT following the framework of the Virtual Reality Clinical Outcomes Research Experts Committee. METHODS: In this single-centre cross-sectional study, adult patients admitted to the hospital for elective cardiac surgery were included. Acceptability, usability, and tolerability were measured by the validated questionnaires Unified Theory of Acceptance and Use of Technology (acceptability), System Usability Scale (usability), and Virtual Reality Sickness Questionnaire (tolerability). Descriptive statistics were used for the analysis. RESULTS: Twenty-eight participants used the VPT. Results showed high acceptability (mean 16.7 ± 1.5), acceptable usability (mean 86.7 ± 9.3), and high tolerability (sickness score, median 7.1 % [0-17.1 %]). CONCLUSION: The use of the VPT is a feasible and promising technique. The next step is to optimize the content and technique of the VPT based on the suggestions of the participants. PRACTICE IMPLICATIONS: We recommend incorporating the VPT into preoperative patient education in addition to the routine information in cardiac surgery patients.

Feasibility and findings of electrocardiogram recording in older adults with intellectual disabilities: results of the Healthy Ageing and Intellectual Disabilities study.

BACKGROUND: Older adults with intellectual disabilities (ID) have a high risk of cardiovascular diseases (CVD). At the same time, challenging diagnostic work-up increases the likelihood of underdiagnosis of CVD in this population. To limit this underdiagnosis, it would be beneficial to use objective measures such as the electrocardiogram (ECG). However, little is known about the feasibility of ECG recording and the prevalence of ECG abnormalities in this population. Therefore, the aims of this study were to investigate the feasibility of resting ECG recording, to study the prevalence of ECG abnormalities, and to compare the frequency of ECG abnormalities with medical records in older adults with ID. METHOD: A cross-sectional study was performed within a cohort of older adults (≥60 years) with ID as part of the Healthy Ageing and Intellectual Disabilities (HA-ID) study. A resting 12-lead ECG was attempted, and the ECG recording was considered feasible if the recording could be made and if the ECG could be interpreted by a cardiologist and the Modular ECG Analysis System (MEANS). ECGs were assessed for the presence of ECG abnormalities and medical record review was performed. If the cardiologist or MEANS concluded that there was evidence of myocardial infarction, atrial fibrillation or QTc prolongation on the ECG in the absence of this ECG diagnosis in the participant's medical record, this was classified as a previously undiagnosed ECG diagnosis. RESULTS: ECG recording was feasible in 134 of the 200 participants (67.0%). Of these 134 participants (70.6 ± 5.8 years; 52.2% female), 103 (76.9%) had one or more ECG abnormality, with the most prevalent being prolonged P-wave duration (27.6%), QTc prolongation (18.7%), minor T-wave abnormalities (17.9%), first degree atrioventricular block (12.7%) and myocardial infarction (6.7%). Eight out of 9 (88.9%) myocardial infarctions and all cases of (significant) QTc prolongation (100%) were previously undiagnosed. CONCLUSIONS: This study showed that ECG recording is feasible in the majority of older adults with ID and revealed a substantial underdiagnosis of ECG abnormalities. These results stress the importance of ECG recording and warrant further research into the yield of opportunistic ECG screening in older adults with ID.

Perinatal outcomes after a prenatal diagnosis of a fetal copy number variant: a retrospective population-based cohort study.

BACKGROUND: There are no established guidelines for the follow up of infants born after a prenatal diagnosis of a genomic copy number variant (CNV), despite their increased risk of developmental issues. The aims of this study were (i) to determine the perinatal outcomes of fetuses diagnosed with and without a CNV, and (ii) to establish a population-based paediatric cohort for long term developmental follow up. METHODS: An Australian state-wide research database was screened for pregnant individuals who had a prenatal chromosomal microarray (CMA) between 2013-2019 inclusive. Following linkage to laboratory records and clinical referrer details, hospital records were manually reviewed for study eligibility. Eligible participants were mother-child pairs where the pregnancy resulted in a livebirth, the mother was able to provide informed consent in English (did not require a translator) and the mother was the primary caregiver for the child at hospital discharge after birth. Research invitations were sent by registered post at an average of six years after the prenatal diagnostic test. Statistical analysis was performed in Stata17. RESULTS: Of 1832 prenatal records examined, 1364 (74.5%) mother-child pairs were eligible for recruitment into the follow up cohort. Of the 468 ineligible, 282 (60.3%) had 'no live pregnancy outcome' (209 terminations of pregnancy (TOP) and 73 miscarriages, stillbirths, and infant deaths), 157 (33.5%) required a translator, and 29 (6.2%) were excluded for other reasons. TOP rates varied by the type of fetal CNV detected: 49.3% (109/221) for pathogenic CNVs, 18.2% (58/319) for variants of uncertain significance and 3.3% (42/1292) where no clinically significant CNV was reported on CMA. Almost 77% of invitation letters were successfully delivered (1047/1364), and the subsequent participation rate in the follow up cohort was 19.2% (201/1047). CONCLUSIONS: This study provides Australia's first population-based data on perinatal outcomes following prenatal diagnostic testing with CMA. The relatively high rates of pregnancy loss for those with a prenatal diagnosis of a CNV presented a challenge for establishing a paediatric cohort to examine long term outcomes. Recruiting a mother-child cohort via prenatal ascertainment is a complex and resource-intensive process, but an important step in understanding the impact of a CNV diagnosis in pregnancy and beyond. TRIAL REGISTRATION: ACTRN12620000446965p; Registered on April 6, 2020.

Main Paths of Brain Fibers in Diffusion Images Mixed with a Noise to Improve Performance of Tractography Algorithm-Evaluation in Phantom.

Background: Some voxels may alter the tractography results due to unintentional alteration of noises and other unwanted factors. Objective: This study aimed to investigate the effect of local phase features on tractography results providing data are mixed by a Gaussian or random distribution noise. Material and Methods: In this simulation study, a mask was firstly designed based on the local phase features to decrease false-negative and -positive tractography results. The local phase features are calculated according to the local structures of images, which can be zero-dimensional, meaning just one point (equivalent to noise in tractography algorithm), a line (equivalent to a simple fiber), or an edge (equivalent to structures more complex than a simple fiber). A digital phantom evaluated the feasibility current model with the maximum complexities of configurations in fibers, including crossing fibers. In this paper, the diffusion images were mixed separately by a Gaussian or random distribution noise in 2 forms a zero-mean noise and a noise with a mean of data. Results: The local mask eliminates the pixels of unfitted values with the main structures of images, due to noise or other interferer factors. Conclusion: The local phase features of diffusion images are an innovative solution to determine principal diffusion directions.

Pilot trial protocol: community intervention to improve depressive symptoms among Peruvian older adults.

BACKGROUND: Non-pharmacological interventions have proven effective at alleviating depression and anxiety symptoms in older adults. Methodological refinement and testing of these interventions in new contexts are needed on a small scale before their effectiveness and implementation can be evaluated. The purpose of this pilot study is to assess the feasibility of a future large-scale trial comparing an adapted mental health multi-component evidence-based intervention (VIDACTIVA) versus standard care for older adults experiencing depression symptoms in urban, resource-limited settings in Lima, Peru. Furthermore, this study will explore the acceptability, feasibility, and fidelity of implementing the intervention. METHODS: We will conduct an open-label, mixed methods pilot feasibility study with two parallel groups. A total of 64 older adults, stratified by sex, will be randomized at a 1:1 ratio to either the "intervention" or "control." Participants will be followed for 22 weeks after enrollment. Those in the intervention group will receive eight VIDACTIVA sessions administered by community health workers (CHWs) over 14 weeks, with an additional eight weeks of follow-up. Participants in the control group will receive two psychoeducation sessions from a study fieldworker and will be directed to health care centers. Standard care does not involve CHWs. We will evaluate screening rates, recruitment strategies, retention rates, the acceptability of randomization, and assessments. Additionally, we will assess preliminary implementation outcomes-acceptability, feasibility, and fidelity-from the perspectives of CHWs (interventionists), older adults (main participants), older adults' relatives, and healthcare professionals. DISCUSSION: If the findings from this feasibility trial are favorable, a fully powered randomized controlled trial will be conducted to evaluate `both the effectiveness and implementation of the intervention. This research will make a substantial contribution to the field of mental health in older adults, particularly by emphasizing a meticulous examination and documentation of the implementation process. By doing so, this study will offer valuable methodologies and metrics for adapting and assessing mental health interventions tailored to the unique needs of older adults in resource-constrained contexts and diverse cultural settings. TRIAL REGISTRATION: The current trial registration number is NCT06065020, which was registered on 26th September 2023.

Low dose optimization for total-body 2-[18F]FDG PET/CT imaging: a single-center study on feasibility based on body mass index stratification.

OBJECTIVES: Implementing personalization protocol in clinical routine necessitates diverse low-dose PET/CT scan protocols. This study explores the clinical feasibility of one-third (1/3) dose regimen and evaluates the diagnostic image quality and lesion detectability of BMI-based 1/3-injection doses for 2-[18F]FDG PET/CT imaging. METHODS: Seventy-four cancer patients underwent total-body 2-[18F]FDG PET/CT examination, with 37 retrospectively enrolled as full-dose group (3.7 MBq/kg) and 37 prospectively enrolled as the 1/3-dose group (1.23 MBq/kg). The 1/3-dose group was stratified by BMI, with an acquisition time of 5 min (G5), 6 min (G6), and 8 min (G8) for BMI < 25, 25 ≤ BMI ≤ 29, and BMI > 29, respectively. Image quality was subjectively and objectively assessed, and lesion detectability was quantitatively analyzed. RESULTS: Subjective assessments of 1/3-dose and full-dose PET images showed strong agreement among readers (κ > 0.88). In the 1/3-dose group, the Likert scores were above 4. G5, G6, and G8 showed comparable image quality, with G5 demonstrating higher lesion conspicuity than G6 and G8 (p = 0.045). Objective evaluation showed no significant differences in SUVmax, liver SUVmean and TBR between 1/3- and full-dose groups (p > 0.05). No statistical differences were observed in the SUVmax of primary tumor, SUVmean of liver and TBR across all BMI categories between the 1/3-dose and full-dose groups. Lesion detection rates showed no significant difference between the 1/3-dose (93.24%, 193/207) and full-dose groups (94.73%, 198/209) (p = 0.520). CONCLUSION: A BMI-stratified 1/3-dose regimen is a feasible low-dose alternative with clinically acceptable lesion detectability equivalent to full-dose protocol, potentially expanding the applicability of personalized protocols. CLINICAL RELEVANCE STATEMENT: This study demonstrated that BMI-stratified 1/3-dose regimens for [18F]FDG total-body PET/CT yielded equivalent outputs compared to the full-dose regimen, which aligns with clinical needs for personalization in dose and BMI. KEY POINTS: Currently, limited personalized low-dose total-body PET/CT protocols are available, particularly for patients with varied BMI. Reducing the radiotracer dose to 1/3 the standard demonstrated comparable image quality and lesion detectability equivalent to full dose. BMI-stratified 1/3-dose regimen is a clinically feasible low-dose alternative.

Recovering from COVID-19 (ReCOV): Feasibility of an Allied-Health-Led Multidisciplinary Outpatient Rehabilitation Service for People with Long COVID.

BACKGROUND: A multidisciplinary approach is required for the management of long COVID. The aim of this study was to determine the feasibility (demand, implementation, practicality, acceptability, and limited efficacy) of an allied-health-led multidisciplinary symptom management service (ReCOV) for long COVID. METHODS: A single-group observational cohort feasibility study was conducted to determine demand (referrals), acceptability (survey), implementation (waitlist times, health professions seen), practicality (adverse events), and limited efficacy (admission and discharge scores from the World Health Organization Disability Assessment Scale, Brief Illness Perception Questionnaire (BIPQ), Patient Health Questionnaire, and EuroQol 5D-5L). Data are presented as median [interquartile range] or count (percentage). RESULTS: During the study, 143 participants (aged 42.00 [32.00-51.00] years, 68% women) participated in ReCOV. Participants were waitlisted for 3.86 [2.14-9.86] weeks and engaged with 5.00 [3.00-6.00] different health professionals. No adverse events occurred. The thematic analysis revealed that ReCOV was helpful but did not fully meet the needs of all participants. Limited efficacy testing indicated that participants had improved understanding and control (p < 0.001) of symptoms (BIPQ) and a small improvement in EQ VAS score (median difference 5.50 points [0.00-25.00], p = 0.004]). CONCLUSIONS: A multidisciplinary service was safe and mostly acceptable to participants for the management of long COVID. Further research should investigate the clinical and cost effectiveness of such a service, including optimal service duration and patient outcomes.

Boosting enjoyment and social inclusion to increase physical activity and reduce sedentary behaviour among older adults: protocol for a feasibility study to test the JOIN4JOY approach in five European countries.

INTRODUCTION: Programmes for older people aimed at increasing physical activity (PA) and reducing sedentary behaviour (SB) traditionally focus on achieving functional and health improvements. Focusing on enjoyment and social inclusion could strengthen adherence and help reach older people with social disadvantages. The aim of this study is to assess the feasibility and acceptability of the Join4Joy approach in PA programmes and its assessment tools. METHODS AND ANALYSIS: A multicentric, pragmatic, pre-post feasibility study using mixed methods will be conducted. The intervention will consist of a PA programme boosting enjoyment and social inclusion, grounded on a co-creation process. Trainers will offer twelve, 1-hour weekly sessions of structured, supervised, group-based PA. Participants will be encouraged to increase activity in daily living. 144 older people will be recruited from the community and nursing homes in Spain, Denmark, Italy, Germany, and France. Additionally, participants and trainers will be invited to join virtual communities of practice to share their experiences across settings and countries. Qualitative procedures will be used to explore the acceptability of the design via interviews and focus groups with participants and trainers. Quantitative methods will be used to assess uptake, adherence, retention, reach, satisfaction, enjoyment (PACES questionnaire), physical function (e.g., Short Physical Performance Battery), quality of life (EQ-5D-5L scale), perceived improvement (Patient Global Impression of Improvement scale-I), activities of daily living (Barthel index) and SB and PA patterns (IPAQ and accelerometry). The degree and type of participation in virtual communities of practice will also be assessed. SPSS software will be used for the analysis of quantitative variables. Qualitative data will be analysed using reflective thematic analysis following Braun and Clarke (2006). ETHICS AND DISSEMINATION: A favourable report by the Research Ethics Committee of UVic-UCC (282/2023) was obtained on 26 June 26th, 2023. Participation and withdrawal will be voluntary. Participants' (or their legal guardians', when necessary) written permission will be required. Results of the study will be disseminated through publication of scientific articles, presentations at sport and health-related professional conferences and congresses, as well as through social media and via the Join4Joy website. STUDY REGISTRATION: ClinicalTrials.gov, NCT06100835.

Feasibility and diagnostic accuracy of fast whole-body MRI in slightly to moderately injured trauma patients.

OBJECTIVES: To determine the feasibility and diagnostic accuracy of fast whole-body magnetic resonance imaging (WB-MRI) compared to whole-body computed tomography (WB-CT) in detecting injuries of slightly to moderately injured trauma patients. MATERIALS AND METHODS: In a prospective single-center approach, trauma patients from convenience sampling with an expected Abbreviated Injury Scale (AIS) score ≤ 3 at admission, received an indicated contrast-enhanced WB-CT (reference standard) and a plain WB-MRI (index test) voluntarily up to five days after trauma. Two radiologists, blinded to the WB-CT findings, evaluated the absence or presence of injuries with WB-MRI in four body regions: head, torso, axial skeleton, and upper extremity. Diagnostic accuracy was determined using sensitivity, specificity, positive predictive value, and negative predictive value by body region. RESULTS: Between June 2019 and July 2021, 40 patients were assessed for eligibility of whom 35 (median age (interquartile range): 50 (32.5) years; 26 men) received WB-MRI. Of 140 body regions (35 patients × 4 regions), 31 true positive, 6 false positive, 94 true negative, and 9 false negative findings were documented with WB-MRI. Thus, plain WB-MRI achieved a total sensitivity of 77.5% (95%-confidence interval (CI): (61.6-89.2%)), specificity of 94% (95%-CI: (87.4-97.8%)), and diagnostic accuracy of 89.3% (95%-CI: (82.9-93.9%)). Across the four regions sensitivity and specificity varied: head (66.7%/93.1%), torso (62.5%/96.3%), axial skeleton (91.3%/75%), upper extremity (33.3%/100%). Both radiologists showed substantial agreement on the WB-MRI reading (Cohen's Kappa: 0.66, 95%-CI: (0.51-0.81)). CONCLUSION: Regarding injury detection, WB-MRI is feasible in slightly to moderately injured trauma patients, especially in the axial skeleton. CLINICAL RELEVANCE STATEMENT: Besides offering a radiation-free approach, whole-body MRI detects injuries almost identically to whole-body CT in slightly to moderately injured trauma patients, who comprise a relevant share of all trauma patients. KEY POINTS: Whole-body MRI could offer radiation-free injury detection in slightly to moderately injured trauma patients. Whole-body MRI detected injuries almost identically compared to whole-body CT in this population. Whole-body MRI could be a radiation-free approach for slightly to moderately injured young trauma patients.

Acceptability and feasibility of a theatre-based wellness programme to support people living with long COVID: a single-arm feasibility study.

OBJECTIVES: To determine acceptability and feasibility of a theatre-based wellness programme to support the health and well-being of people with long COVID. DESIGN: Single-group, repeated-measures feasibility study. SETTING: Community centre and online. PARTICIPANTS: Adults with diagnosed long COVID experiencing breathlessness, pain and/or loneliness. INTERVENTION: Six-week participatory creative programme delivered to one online and one in-person group facilitated by movement, voice and drama consultants using breathing, visualisation, singing, poetry, storytelling and movement exercises. PRIMARY OUTCOME MEASURES: Programme acceptability and feasibility measured via uptake, reasons for non-attendance and barriers to engagement. SECONDARY OUTCOME MEASURES: Feasibility of recruitment and data collection procedures measured through proportion of missing data and follow-up rates, mechanisms of action of the programme identified through qualitative interviews, changes in mental health, well-being, quality of life, loneliness, social support, fatigue, breathlessness and post-COVID-19 functional status at 8-week follow-up. RESULTS: 21 people expressed interest in participating, 20 people took part in the programme, 19 completed baseline and 16 completed follow-up assessments. Participants attended an average of 4.8 of 6 sessions (SD=1.5, range 2-6). Exploratory analyses demonstrated significant improvements in self-rated health (t-test mean difference=0.12, 95% CI=0.00, 0.23, p=0.04) and chronic fatigue symptoms (mean difference=-3.50, 95% CI=-6.97, -0.03, p=0.05) at 8 weeks. Key mechanisms of action that supported health and well-being included: increased sense of community, illness acceptance, experiencing joy, increased confidence in managing everyday life, increased ability to relax and reconnection with previous identity. Barriers to engagement included: activities being outside of the participant's comfort zone, ongoing long COVID symptoms, emotional consequences of sharing experiences and connectivity and connecting online. CONCLUSIONS: A 6-week theatre-based programme was perceived as acceptable to most participants and resulted in some positive psychosocial impacts. The findings provide a rationale for supporting the ongoing development and scale-up of this and related arts programmes to support people living with long COVID.