A randomized feasibility trial of medium chain triglyceride-supplemented ketogenic diet in people with Parkinson's disease.

BACKGROUND: A ketogenic diet (KD) may benefit people with neurodegenerative disorders marked by mitochondrial depolarization/insufficiency, including Parkinson's disease (PD). OBJECTIVE: Evaluate whether a KD supplemented by medium chain triglyceride (MCT-KD) oil is feasible and acceptable for PD patients. Furthermore, we explored the effects of MCT-KD on blood ketone levels, metabolic parameters, levodopa absorption, mobility, nonmotor symptoms, simple motor and cognitive tests, autonomic function, and resting-state electroencephalography (rsEEG). METHODS: A one-week in-hospital, double-blind, randomized, placebo-controlled diet (MCT-KD vs. standard diet (SD)), followed by an at-home two-week open-label extension. The primary outcome was KD feasibility and acceptability. The secondary outcome was the change in Timed Up & Go (TUG) on day 7 of the diet intervention. Additional exploratory outcomes included the N-Back task, Unified Parkinson's Disease Rating Scale, Non-Motor Symptom Scale, and rsEEG connectivity. RESULTS: A total of 15/16 subjects completed the study. The mean acceptability was 2.3/3, indicating willingness to continue the KD. Day 7 TUG time was not significantly different between the SD and KD groups. The nonmotor symptom severity score was reduced at the week 3 visit and to a greater extent in the KD group. UPDRS, 3-back, and rsEEG measures were not significantly different between groups. Blood ketosis was attained by day 4 in the KD group and to a greater extent at week 3 than in the SD group. The plasma levodopa metabolites DOPAC and dopamine both showed nonsignificant increasing trends over 3 days in the KD vs. SD groups. CONCLUSIONS: An MCT-supplemented KD is feasible and acceptable to PD patients but requires further study to understand its effects on symptoms and disease. TRIAL REGISTRATION: Trial Registration Number NCT04584346, registration dates were Oct 14, 2020 - Sept 13, 2022.

Feasibility of outpatient daycase local anaesthestic Rezum™ without sedation.

BACKGROUND: Rezum™ is a relatively new bladder outflow obstruction (BOO) procedure that uses thermal energy through water vapour to cause necrosis of prostatic tissue. The standard delivery of this treatment is in an operating theatre under a general or spinal anaesthetic, or under local anaesthetic with sedation that requires patient monitoring. METHODS: We propose an outpatient daycase method of delivering Rezum™ under local anaesthetic without sedation, using a prostatic local anaesthetic block and cold local anaesthetic gel instillation into the urethra. RESULTS: Preliminary results of our first thirteen patients demonstrate the feasibility of this new technique, with a mean pain score of 2.1 out of 10 on a visual analogue scale, a successful trial without catheter in all 13 patients (one patient voided successfully on second trial), a reduction in mean International Prostate Symptom Score (IPSS) from 20.6 to 5.4, and improvement in maximum flow from 8.8 ml/s to 14.4 ml/s. The complications were minor (Clavien-Dindo less than III) and included a UTI, minor bleeding not requiring admission, and retrograde ejaculation. CONCLUSIONS: We demonstrate that an outpatient local anaesthetic daycase service without sedation is feasible. This can be delivered in a clinic setting, reduce waiting times for BOO surgery, and increase availability of operating theatre for other general anaesthetic urological procedures.

The Development and Feasibility of a Novel Group Intervention to Support Helping Professionals in Metabolizing Suffering and Engaging Strengths: The CHRYSALIS Program.

This feasibility study reports on the development and initial evaluation of a novel online intervention for helping professionals (HPs; i.e. mental health professionals, chaplains, clergy) designed to (a) address occupational hazards, such as burnout and vicarious traumatization, and (b) promote well-being and flourishing at work. In contrast with competency and self-care focused models, the CHRYSALIS (Catalyzing Helping Professionals' Resilience, VitalitY, Spirituality, Authentic Living, and Inner Strength) intervention centers the self of the provider, explores cultural and spiritual contexts, and attends to systemic challenges. As part of a larger randomized controlled trial evaluating two program formats, the group format entails eight online sessions exploring strengths that can promote well-being, including processing, relational, vitalizing, orienting, and agentic capacities. To pilot test this framework and establish proof of concept, this study analyzed data from 41 HPs who had been randomly assigned to the group condition and completed surveys at four time points. Quantitative results indicated significant reductions in vicarious traumatization and burnout as well as increased well-being and meaning in work. Qualitative results suggest the intervention fostered relational support, cultivated new perspectives, and increased engagement with strengths, positively impacting participants' work and navigation of caregiving systems. Feedback about cohesion and group dynamic challenges in an online format informed further program development. This study provides initial support for the feasibility and efficacy of the group format of the CHRYSALIS intervention as a creative means to address HPs' risk for occupational hazards and promote holistic formation in a relational context.

An imagery rescripting based intervention in children and adolescents who endured a negative life event: A pilot study, satisfaction and feasibility survey.

BACKGROUND AND OBJECTIVES: ImRs, a technique targeting distressing mental images, has shown promise in adult psychiatric treatment. Initial research indicates positive outcomes in children, with potential for reducing mental health care burden. This pilot study examined the use of Imagery Rescripting (ImRs) as an intervention for children who have experienced negative life events. We aimed to assess short-term emotional changes, participant satisfaction, and the feasibility of a larger-scale ImRs intervention for children. METHODS: We employed a pre-posttest within-group design, and included 35 children (ages 5-18) who experienced negative life events, as well as 12 coaches. ImRs targeted distressing images related to negative events. Measurement tools included Visual Analogue Scales for distress and emotions, along with satisfaction surveys for both children and coaches. The feasibility of a larger-scale study was also explored through a coach questionnaire. RESULTS: We found significant short-term improvements for all emotional states, with large effects for anxiety, sadness, and happiness, and a moderate effect for anger. Children reported fair levels of satisfaction with the intervention's acceptability and complexity. Coaches expressed high levels of satisfaction with the intervention as a whole and with its characteristics. Coaches were also strongly motivation for future, more in-depth research. An important limitation of this pilot study was the lack of a control group. In light of the promising results, more extensive studies with diagnostic information, multiple measures, and follow-up assessments are warranted. CONCLUSION: Altogether, imagery rescripting based interventions seem a promising venue for children who experienced negative events.

Effectiveness of naturopathy for pregnancy in women with diminished ovarian reserve: feasibility randomized controlled trial.

RESEARCH QUESTION: Is conducting a randomized control trial (RCT) to assess the effectiveness of whole-system naturopathy in improving pregnancy rates among women with diminished ovarian reserve (DOR) feasible? DESIGN: A two-arm, parallel group, assessor-blinded feasibility RCT was conducted. Women with DOR, trying to conceive naturally or by ART, were randomly assigned to naturopathy plus usual care, or usual care alone for 16 weeks. Primary outcomes were feasibility (recruitment, adherence, retention rates), acceptability and safety. Secondary outcomes included ongoing pregnancy rates, live birth rates and health-related outcomes (mental health, quality of life, diet, exercise, sleep and weight). Statistical significance of the differences between the two groups (P-values) were exploratory. RESULTS: One hundred and fifteen women completed the screening survey between March and November 2022. Of these, 66 women were assessed for eligibility and 41 (62%) consented. Recruitment resulted in seven enrolments each month. All 41 participants (100%) adhered to the intervention, 38 (93%) completed end-point questionnaires, 32 (78%) found study participation to be acceptable and 18 out of 21 (86%) from the intervention group would recommend a naturopathic intervention to other women with DOR. The naturopathic treatment was associated with only mild and temporary adverse events. No between-group differences were observed for pregnancy and live birth rates. CONCLUSION: The evaluation of whole-system naturopathy through a RCT was feasible and the treatment was acceptable and well tolerated according to women with DOR. Outcomes from this study will help inform sample size calculations powered for fertility outcomes for future RCTs on this topic.

Local hyperthermia mediated by gold nanoparticle-integrated silicone-covered stent: feasibility and tissue response in a rat esophageal model.

BACKGROUND: To assess the feasibility and tissue response of using a gold nanoparticle (AuNP)-integrated silicone-covered self-expandable metal stent (SEMS) for local hyperthermia in a rat esophageal model. METHODS: The study involved 42 Sprague-Dawley rats. Initially, 6 animals were subjected to near-infrared (NIR) laser irradiation (power output from 0.2 to 2.4 W) to assess the in vitro heating characteristics of the AuNP-integrated SEMS immediately after its placement. The surface temperature of the stented esophagus was then measured using an infrared thermal camera before euthanizing the animals. Subsequently, the remaining 36 animals were randomly divided into 4 groups of 9 each. Groups A and B received AuNP-integrated SEMS, while groups C and D received conventional SEMS. On day 14, groups A and C underwent NIR laser irradiation at a power output of 1.6 W for 2 min. By days 15 (3 animals per group) or 28 (6 animals per group), all groups were euthanized for gross, histological, and immunohistochemical analysis. RESULTS: Under NIR laser irradiation, the surface temperature of the stented esophagus quickly increased to a steady-state level. The surface temperature of the stented esophagus increased proportionally with power outputs, being 47.3 ± 1.4 °C (mean ± standard deviation) at 1.6 W. Only group A attained full circumferential heating through all layers, from the epithelium to the muscularis propria, demonstrating marked apoptosis in these layers without noticeable necroptosis. CONCLUSIONS: Local hyperthermia using the AuNP-integrated silicone-covered SEMS was feasible and induced cell death through apoptosis in a rat esophageal model. RELEVANCE STATEMENT: A gold nanoparticle-integrated silicone-covered self-expanding metal stent has been developed to mediate local hyperthermia. This approach holds potential for irreversibly damaging cancer cells, improving the sensitivity of cancer cells to therapies, and triggering systemic anticancer immune responses. KEY POINTS: • A gold nanoparticle-integrated silicone-covered self-expanding metal stent was placed in the rat esophagus. • Upon near-infrared laser irradiation, this stent quickly increased the temperature of the stented esophagus. • Local hyperthermia using this stent was feasible and resulted in cell death through apoptosis.

"sCT-Feasibility" - a feasibility study for deep learning-based MRI-only brain radiotherapy.

BACKGROUND: Radiotherapy (RT) is an important treatment modality for patients with brain malignancies. Traditionally, computed tomography (CT) images are used for RT treatment planning whereas magnetic resonance imaging (MRI) images are used for tumor delineation. Therefore, MRI and CT need to be registered, which is an error prone process. The purpose of this clinical study is to investigate the clinical feasibility of a deep learning-based MRI-only workflow for brain radiotherapy, that eliminates the registration uncertainty through calculation of a synthetic CT (sCT) from MRI data. METHODS: A total of 54 patients with an indication for radiation treatment of the brain and stereotactic mask immobilization will be recruited. All study patients will receive standard therapy and imaging including both CT and MRI. All patients will receive dedicated RT-MRI scans in treatment position. An sCT will be reconstructed from an acquired MRI DIXON-sequence using a commercially available deep learning solution on which subsequent radiotherapy planning will be performed. Through multiple quality assurance (QA) measures and reviews during the course of the study, the feasibility of an MRI-only workflow and comparative parameters between sCT and standard CT workflow will be investigated holistically. These QA measures include feasibility and quality of image guidance (IGRT) at the linear accelerator using sCT derived digitally reconstructed radiographs in addition to potential dosimetric deviations between the CT and sCT plan. The aim of this clinical study is to establish a brain MRI-only workflow as well as to identify risks and QA mechanisms to ensure a safe integration of deep learning-based sCT into radiotherapy planning and delivery. DISCUSSION: Compared to CT, MRI offers a superior soft tissue contrast without additional radiation dose to the patients. However, up to now, even though the dosimetrical equivalence of CT and sCT has been shown in several retrospective studies, MRI-only workflows have still not been widely adopted. The present study aims to determine feasibility and safety of deep learning-based MRI-only radiotherapy in a holistic manner incorporating the whole radiotherapy workflow. TRIAL REGISTRATION: NCT06106997.

Evaluating the Feasibility and Acceptability of a Psychosexual Intervention for Couples Post-allogeneic Hematopoietic Stem Cell Transplantation.

PURPOSE: Allogeneic hematopoietic stem cell transplantation (HSCT) can have a long-term impact on patients' sexual functioning and consequently, their relationship satisfaction. This study aimed to examine the feasibility and acceptability of a 5-session psychosexual intervention for HSCT survivors and their partners. METHODS: To be eligible patients were required to be more than 3 months post-allogeneic HSCT. The intervention comprised 2 components: (1) A psychosexual education session exploring medical/behavioral treatment options for sexual dysfunction, delivered by a specialist nurse; (2) A 4-session Emotionally-Focused Therapy-based relationship education program for couples delivered by a clinical psychologist. Measures assessing relationship quality, sexual functioning, anxiety, and depression were administered pre- and post-intervention. Feasibility was measured via participation rate, adherence and compliance with completing main measures. Acceptability of the intervention was assessed via patient/partner satisfaction surveys. RESULTS: Eight of 85 (9.4%) eligible patients and their partners participated in the study. Reasons for declining participation included: feeling uncomfortable due to sensitive nature of intervention; did not have any relationship/sexual function issues; and experiencing ongoing medical issues. Six of 8 couples (75%) attended at least 4 intervention sessions and 5 of 8 (62.5%) completed the main study measures post-intervention. Four couples reported that sexual satisfaction and relationship satisfaction was somewhat or much better post-intervention; 1 reported no change. CONCLUSION: Feasibility criteria were not met, with low enrolment rate, however the intervention was deemed acceptable. Couples who participated adhered to the intervention and considered it beneficial. Further strategies to identify and manage sexual concerns are required.

A feasibility study on indoor therapeutic horticulture to alleviate sleep and anxiety problems: The impact of plants and activity choice on its therapeutic effect.

INTRODUCTION: Therapeutic horticulture (TH) is increasingly being applied for sub-health or patient mental health care. Whether plant and activity type will affect TH's effectiveness is unclear. AIM: To evaluate the feasibility of an indoor TH for alleviating the anxiety symptoms and sleeping problems of people with poor sleep quality, and explore the potential affection of plant and activity type on health benefits. METHOD: Thirty subjects (all with sleep problems and half with anxiety problems) were randomly assigned to three groups to do horticultural activities with ornamental plants, general aromatic plants, or aromatic plants with reported mental health functions, respectively. Six indoor TH activities were then held sequentially within two weeks. Psychological scales, subjective feedback questionnaires, and physiological indicators were used as evaluation indexes before and after horticulture activities. RESULTS: The TH relieved subjects' sleep and anxiety problems and was particularly effective in alleviating anxiety among people with high anxiety levels. Using ornamental plants was more effective in relieving stress while functional aromatic plants performed better in sleep improvement and satisfaction to TH. Each horticultural activity could improve mood state but showed different effects on the vitality of the participants. CONCLUSION: The above findings provided some basis for the potential benefits of selecting plants and activities based on psychological care needs in the development of TH plans. Future research that expands upon the current project is warranted. A larger sample size is beneficial for obtaining more powerful statistical results.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.

INTRODUCTION: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme. METHODS AND ANALYSIS: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them. ETHICS AND DISSEMINATION: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000584730.

Assessing adverse events associated with chiropractic care in preschool pediatric population: a feasibility study.

BACKGROUND: Manual therapies are commonly used by healthcare professionals when caring for children. However, few prospective studies have evaluated their adverse events (AEs). This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger. Preliminary data on AEs frequency are also reported. METHODS: Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data. RESULTS: Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child's participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research. CONCLUSION: Results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians' recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study. TRIAL REGISTRATION: ClinicalTrials.gov., NCT05409859, Registered on June 3 2022. https://clinicaltrials.gov/study/NCT05409859 .

Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers.

OBJECTIVES: Concurrent chemoradiation to treat head and neck cancer (HNC) may result in debilitating toxicities. Targeted exercise such as yoga therapy may buffer against treatment-related sequelae; thus, this pilot RCT examined the feasibility and preliminary efficacy of a yoga intervention. Because family caregivers report low caregiving efficacy and elevated levels of distress, we included them in this trial as active study participants. METHODS: HNC patients and their caregivers were randomized to a 15-session dyadic yoga program or a waitlist control (WLC) group. Prior to randomization, patients completed standard symptom (MDASI-HN) and patients and caregivers completed quality of life (SF-36) assessments. The 15-session program was delivered parallel to patients' treatment schedules. Participants were re-assessed at patients' last day of chemoradiation and again 30 days later. Patients' emergency department visits, unplanned hospital admissions and gastric feeding tube placements were recorded over the treatment course and up to 30 days later. RESULTS: With a consent rate of 76%, 37 dyads were randomized. Participants in the yoga group completed a mean of 12.5 sessions and rated the program as "beneficial." Patients in the yoga group had clinically significantly less symptom interference and HNC symptom severity and better QOL than those in the WLC group. They were also less likely to have a hospital admission (OR = 3.00), emergency department visit (OR = 2.14), and/or a feeding tube placement (OR = 1.78). CONCLUSION: Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation. A larger efficacy trial is warranted.

Tailored Yoga Intervention for Postlumbar Spine Surgical Pain Management: A Feasibility Study.

Introduction: Severe pain, anxiety, and high opioid use are common following lumbar spine surgery (LSS). Yoga helps to reduce pain and anxiety, but it has not been considered for postsurgical care. The authors developed and tested the feasibility of a tailored yoga program designed for individuals undergoing LSS and explored clinical feasibility of yoga intervention on measures of pain, function, psychological status, and opioid use. Methods: Individuals scheduled for LSS were randomized into yoga versus control groups presurgery. Participants in the yoga group received tailored yoga sessions plus usual care, whereas participants in the control group received usual care only during the hospital stay post-LSS. In-person daily yoga sessions were individually presented and performed in the participant's hospital room. Feasibility was assessed by recruitment and retention rates, rate of yoga session completion, tolerance to yoga intervention, and ability to carry out planned assessment. Exploratory clinical outcomes included pain, psychological measures, Timed-Up-and-Go test, gait distance, and opioid use, during the hospital stay post-LSS. Results: Forty-one participants were enrolled, of which 30 completed. There were no dropouts. Planned assessments were completed within 45 min, suggesting no excessive burden on participants. Baseline variables were similar across both groups. The majority of participants participated in yoga intervention on the day of surgery or one day after surgery with acceptance rate of 100%. Participants showed good tolerance to yoga intervention on 0-4 tolerance scale and by their reports of exploratory clinical outcomes. Conclusion: This study indicates feasibility for a modified yoga program for postoperative care following LSS due to participant tolerance and retention. The results provide preliminary framework for future confirmatory studies that can assess the potential benefits of yoga in reducing pain, catastrophizing behavior, and opioid use and improving function. A modified yoga program focusing on diaphragmatic breathing, relaxation, and core isometric contraction exercises can be an important adjunct intervention for patients undergoing LSS. CTR Number: This trial was registered in UMIN CTR (https://rctportal.niph.go.jp/en/) with registration number: UMIN000032595.

Feasibility of proton dosimetry overriding planning CT with daily CBCT elaborated through generative artificial intelligence tools.

Radiotherapy commonly utilizes cone beam computed tomography (CBCT) for patient positioning and treatment monitoring. CBCT is deemed to be secure for patients, making it suitable for the delivery of fractional doses. However, limitations such as a narrow field of view, beam hardening, scattered radiation artifacts, and variability in pixel intensity hinder the direct use of raw CBCT for dose recalculation during treatment. To address this issue, reliable correction techniques are necessary to remove artifacts and remap pixel intensity into Hounsfield Units (HU) values. This study proposes a deep-learning framework for calibrating CBCT images acquired with narrow field of view (FOV) systems and demonstrates its potential use in proton treatment planning updates. Cycle-consistent generative adversarial networks (cGAN) processes raw CBCT to reduce scatter and remap HU. Monte Carlo simulation is used to generate CBCT scans, enabling the possibility to focus solely on the algorithm's ability to reduce artifacts and cupping effects without considering intra-patient longitudinal variability and producing a fair comparison between planning CT (pCT) and calibrated CBCT dosimetry. To showcase the viability of the approach using real-world data, experiments were also conducted using real CBCT. Tests were performed on a publicly available dataset of 40 patients who received ablative radiation therapy for pancreatic cancer. The simulated CBCT calibration led to a difference in proton dosimetry of less than 2%, compared to the planning CT. The potential toxicity effect on the organs at risk decreased from about 50% (uncalibrated) up the 2% (calibrated). The gamma pass rate at 3%/2 mm produced an improvement of about 37% in replicating the prescribed dose before and after calibration (53.78% vs 90.26%). Real data also confirmed this with slightly inferior performances for the same criteria (65.36% vs 87.20%). These results may confirm that generative artificial intelligence brings the use of narrow FOV CBCT scans incrementally closer to clinical translation in proton therapy planning updates.

Exploring the feasibility and acceptance of an optimised physiotherapy approach for lateral elbow tendinopathy: a qualitative investigation within the OPTimisE trial.

OBJECTIVES: To explore the acceptability of an optimised physiotherapy (OPTimisE) intervention for people with lateral elbow tendinopathy (LET) and feasibility of comparing it to usual care in a randomised controlled trial. DESIGN: Semistructured interviews, analysed using thematic analysis and mapped onto the COM-B model of behaviour change. SETTING: Conducted as part of the OPTimisE Pilot & Feasibility randomised controlled trial within physiotherapy departments in the United Kingdom National Health Service. PARTICIPANTS: 17 patients with LET (purposively sampled to provide representativeness based on age, sex, ethnicity, deprivation index and treatment allocation) and all 8 physiotherapists involved as treating clinicians or site principal investigators. RESULTS: Four themes were identified. First, participants reported the OPTimisE intervention as acceptable. Second, differences between the OPTimisE intervention and usual care were identified, including the use of an orthosis, holistic advice/education including modifiable risk factors, forearm stretches, general upper body strengthening and a more prescriptive exercise-dosing regimen. Third, participants provided feedback related to the trial resources, which were viewed positively, but identified language translation as a need. Fourth, feedback related to trial processes identified the need for changes to outcome collection and reduction of administrative burden. From the perspective of adopting the OPTimisE intervention, we found evidence that participants were able to change their behaviour. Considering the findings through the lens of the COM-B model, the intervention is likely to be deliverable in practice and the trial can be delivered at scale with some additional support for physiotherapists. CONCLUSIONS: Overall, the OPTimisE intervention was found to be different to usual care and acceptable to patients and physiotherapists. The study highlighted the need to refine trial processes and resources prior to a full-scale trial, to reduce administrative burden, increase support for physiotherapists, improve return rate of outcome questionnaires and provide language translation. TRIAL REGISTRATION NUMBER: ISRCTN database 19 July 2021. https://www.isrctn.com/ISRCTN64444585.

Swiss chiropractic cohort (Swiss ChiCo) pilot study: feasibility for a musculoskeletal cohort study conducted within a nationwide practice-based research network.

PURPOSE: Practice-based research networks are collaborations between clinicians and researchers to advance primary care research. This study aims to assess the feasibility for longitudinal data collection within a newly established chiropractic PBRN in Switzerland. METHODS: A prospective observational cohort feasibility study was performed. PBRN participating chiropractors were asked to recruit patients seeking new conservative health care for musculoskeletal pain from March 28, 2022, to September 28, 2022. Participants completed clinically oriented survey questions and patient-reported outcome measures before the initial chiropractic assessment as well as 1 h, 2 weeks, 6 weeks, and 12 weeks thereafter. Feasibility was assessed through a variety of process, resource, and management metrics. Patient clinical outcomes were also assessed. RESULTS: A total of 76 clinicians from 35 unique primary care chiropractic clinics across Switzerland participated. A total of 1431 patients were invited to participate, of which 573 (mean age 47 years, 51% female) were enrolled. Patient survey response proportions were 76%, 64%, 61%, and 56%, at the 1-h, 2-, 6-, and 12-week survey follow-ups, respectively. Evidence of an association was found between increased patient age (OR = 1.03, 95%CI 1.01-1.04), patient from a German-speaking region (OR = 1.81, 95%CI 1.17-2.86), non-smokers (OR = 1.89, 95%CI 1.13-3.17), and increased pain impact score at baseline (OR = 1.18, 95%CI 1.01-1.38) and response to all surveys. CONCLUSION: The Swiss ChiCo pilot study exceeded its prespecified feasibility objectives. Nationwide longitudinal data capture was highly feasible. Similar to other practice-based cohorts, participant retention remains a challenge. Trial registration Swiss chiropractic cohort (Swiss ChiCo) pilot study (ClinicalTrials.gov identifier: NCT05116020).

Exploring the feasibility of bacteriocins EntK1 and EntEJ97s in treatment of systemic vancomycin resistant enterococci infections in mice.

AIMS: Enterocins K1 and EJ97 have specific antimicrobial activity against Enterococcus faecium and Enterococcus faecalis, respectively. The aim of this study was to investigate the utility of these enterocins for in vivo treatment of systemic enterococcal infections. METHODS AND RESULTS: The antimicrobial effect in blood was analysed and compared against the effect in saline. Colony forming unit counts revealed that the enterocins killed all the bacteria within 1 hour. Additionally, the bactericidal effect against E. faecalis was more rapid in blood, indicating a possible synergy between EntEJ97 and blood. Importantly, no enterocin resistant mutants emerged in these experiments. Injecting the enterocins intraperitoneally in an in vivo mouse model and using fluorescence and minimum inhibitory concentration determination to estimate concentrations of the peptides in plasma, indicate that the enterocins exist in circulation in therapeutic concentrations. Alanine aminotransferase detection, and haemolysis analysis indicates that there is no detectable liver damage or haemolytic effect after injection. CONCLUSIONS: The study revealed that EntK1 and EntEJ97 are able to kill all bacteria ex vivo in the presence of blood. In vivo experiments determine that the enterocins exist in circulation in therapeutic concentrations without causing liver damage or haemolysis. Future experiments should test these peptides for treatment of infection in a relevant in vivo model.

A mixed methods analysis of youth mental health intervention feasibility and acceptability in a North American city: Perspectives from Seattle, Washington.

In March 2021, the Governor of Washington declared a youth mental health crisis. State data revealed high rates of youth suicide and inadequate access to services. This study aims to ascertain the kinds of support across the mental health care continuum recommended by young people and key stakeholders who could assist with implementation in Seattle. We interviewed 15 key informants to identify the contextual, structural, and individual-level factors that increase the risk of poor mental health and deter access to care among youth. We complimented these data with a 25-item survey of 117 participants in King County to assess the feasibility and acceptability of interventions for youth mental health. We conducted a deductive thematic qualitative analysis of the interviews and performed descriptive analyses of the quantitative data, using t-tests and χ2 tests to summarize and compare participant characteristics stratified by age group. Qualitative informants attributed challenges to youth mental health to social isolation and relational problems. Example interventions included creating environments that increase belonging and implementation of culturally congruent mental health services. Quantitative study participants rated all evidence-based mental health interventions presented as highly acceptable. However, youth preferred interventions promoting social connectedness, peer support, and holistic approaches to care, while non-youth preferred interventions focused on suicide, and substance abuse prevention. Key informants and survey participants identified schools as the most important setting for mental health interventions. There were no significant differences among quantitative outcomes. Our findings highlight the need for interventions that reduce isolation and increase social connectedness to support youth mental health. As the city designs youth responsive interventions, schools and digital platforms should be prioritized. Engaging multiple stakeholders, particularly young people, tackling cultural stigma surrounding mental health, and improving access to safe community spaces are important considerations for youth mental health interventions.

Feasibility of replacing fish oil with sunflower oil on the growth, body composition, fatty acid profile, antioxidant activity, stress response, and blood biomarkers of Labeo rohita.

A 90-day study was conducted to investigate the effects of substituting sunflower oil (SFO) for fish oil (FO) on various parameters in Labeo rohita (initial weight 18.21 ± 0.22 g). Five experimental diets with different levels of SFO (up to 7%) substitution for FO (0%, 25%, 50%, 75%, and 100%) were formulated, ensuring equal levels of nitrogen and lipids. The results indicated that even with 100% substitution of SFO with FO, there were no significant differences (P>0.05) were observed in growth performance. The survival rate (SR), hepato-somatic index (HSI), and viscero-somatic index (VSI) as well as whole-body composition were also nonsignificant by SFO substitution. However, the fatty acid profiles in both muscle and liver were influenced (P<0.05) by dietary substitution. Saturated fats (SFA) decreased, while monounsaturated fats (MUFA), and linoleic acid (LA) increased (P<0.05). On the other hand, the contribution of linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) decreased (P<0.05) as the amount of SFO in the diet increased. Hematology parameters, including red blood cells (RBCs), hemoglobin (Hb), and hematocrit (Hct), were not affected. Globulin (GLO) levels decreased significantly (P<0.05), while alanine transaminase (ALT) and aspartate transaminase (AST) activity showed nonsignificant increases (P>0.05). Total protein (TP) increased (P<0.05) at 100% SFO inclusion in the diet, and albumin (ALB) levels increased (P<0.05) at 75% and 100% SFO inclusion in the diet. Cholesterol (CHOL), triacylglycerol (TG), and high-density lipids (HDL) were not significantly affected (P>0.05), while low-density lipids (LDL) were significantly increased (P<0.05) compared to the control group. Cortisol (CORT) and glucose (GLU) levels showed nonsignificant (P>0.05) changes. Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and catalase (CAT) activities in the liver and serum were not significantly (P>0.05) affected, while malondialdehyde (MDA) status was significantly (P<0.05) reduced. In conclusion, the fatty acid profile of the muscle and liver of fish was modified by the diets, and FO can be substituted with SFO up to 100% for L. rohita, which is beneficial for growth and immunity while marinating the lipid contents in fish. Our study revealed that fully replacing fish oil with SFO shows promise in fully replacing FO without compromising the growth and overall health status of the fish.

The acceptability, practicality, implementation and efficacy of a physical and social activity intervention 'BreatheHappy' for people with long-term respiratory conditions: A feasibility study.

OBJECTIVES: This study aimed to determine the feasibility of a group-based pilot programme of low-to-moderate physical activity training, education and social activities, by investigating acceptability, practicality, implementation and efficacy testing. We offer suggestions on programme adaptions for future study. METHODS: People with a range of chronic respiratory diseases were invited to participate in a pilot 12 week group activity programme. Activities included outdoor walking, tai-chi, education and a range of social activities. Acceptability was determined by participant experiences determined during interviews. Practicality was determined by programme and outcome measure completion, cost and adverse events. Implementation was determined according to whether the programme ran as planned. Efficacy was determined by statistical analyses of outcomes including hand grip strength, timed up and go test, COPD Helplessness Index, COPD Assessment Test, and measures of physical activity via accelerometry. RESULTS: Thematic analysis indicated that the "BreatheHappy" programme was acceptable. Seven of nine participants completed eight out of 10 sessions and the majority completed all outcome measures. "BreatheHappy" was therefore considered practical. The programme was not implemented as planned, with only 10 sessions running rather than the 12 intended. There was a significant increase in daily step counts (MD: 1284 95% CI: 240-2329 p: 0.024 effect size: 0.988), stepping time (MD: 16 min 95% CI: 5-27 min p: 0.011 effect size: 1.36) and daily minutes completing light physical activity (MD: 23 95% CI: 6-38 p: 0.006 effect size: 1.6). However, time spent sitting for ≥30 min but ≤60 min significantly increased (MD: 26 95% CI: 0.2-52 min p: 0.049 effect size: 0.931), showing signs of efficacy and changing physical activity behaviour patterns. DISCUSSION: A 10-week programme of low-moderate physical activity training, education and social activities shows signs of feasibility for future research. Suggested adaptions for future study include using physical activity measures such as daily step count or light physical activity for a primary outcome, and mental health and social health related outcome measures relatable to participant's beneficial experiences of the programme. Recruitment in future studies will try and reach both those less socially active and possibly those who have completed pulmonary rehabilitation (PR). Venues should be close to efficient transport links whilst different frequencies and durations of programme delivery should be trialled. Adequate funding should be provided for both staff running the programme and blinded research staff for outcome measurement.