Vincristine exposure in Kenyan children with cancer: CHAPATI feasibility study.

The low incidence of vincristine-induced peripheral neuropathy (VIPN) in Kenyan children may result from low vincristine exposure. We studied vincristine exposure in Kenyan children and dose-escalated in case of low vincristine exposure (NCT05844670). Average vincristine exposure was high. Individual vincristine exposure was assessed with a previously developed nomogram. A 20% dose increase was recommended for participants with low exposure and no VIPN, hyperbilirubinemia, or malnutrition. None of the 15 participants developed VIPN. Low vincristine exposure was seen in one participant: a dose increase was implemented without side effects. In conclusion, the participants did not develop VIPN despite having high vincristine exposure.

A group intervention for pregnant multiparas with fear of childbirth: A protocol of a feasibility study of the MOTIVE trial.

BACKGROUND: Although research interest in fear of childbirth has increased, interventions targeting especially multiparas with fear of childbirth have been overlooked, although untreated fear can cause serious adverse effects on the mother and the whole family. Thus MOTIVE (Multiparas overcoming Childbirth Fear Through Intervention and Empowerment), an intervention for pregnant multiparas with fear of childbirth, was designed. METHODS: This is a protocol of a single-arm non-randomized feasibility study of the MOTIVE trial with a mixed-methods design. The primary aim of the intervention is to assist pregnant multiparas with fear of childbirth, with the desired outcome to alleviate fear. MOTIVE consists of four group sessions (2 h each); three during pregnancy and one after giving birth and in addition of a phone call after birth. The intervention is provided by a midwife and a psychiatric nurse at the maternity hospital. Quantitative data will be gathered via self-report questionnaires at three time points, at baseline, at 4 weeks post-baseline and post-intervention. Qualitative data will be gathered by diaries, open-ended questions from post-intervention questionnaires, and individual interviews. The target is to assemble four groups of four multiparas over a 12-month period. DISCUSSION: The findings will provide insights into the feasibility and acceptability of the intervention and will inform revisions to it. The results will guide the development of a definitive, larger-scale trial evaluation to further examine the efficacy of the refined intervention.

A web-based physical activity intervention targeting affect regulation: a randomized feasibility trial.

Early career professionals (ECPs) are a critical target for physical activity (PA) promotion. Affect contributes to an established PA intention-behaviour gap and is pertinent among ECPs. OBJECTIVE: The purpose of this study was to examine the feasibility and acceptability of a web-based intervention and explore the effects on secondary outcomes (moderate-to-vigorous PA (MVPA), emotion regulation, multi-process action control constructs). METHODS: Adults aged 25-44 who were employed at least part-time in a desk-based job and not meeting PA guidelines (<150 min MVPA) were recruited and randomized into a 6-week online intervention integrating acceptance and commitment principles and affect regulation strategies, or a control group. RESULTS: Forty adults were recruited and randomized to the web-based intervention (n = 21) and waitlist control (n = 19). The recruitment rate was 29%, retention was 75%, engagement was 68%, and satisfaction was high in both quantitative and qualitative assessment. Participants allocated to the intervention improved MVPA (ηp2=0.30), emotion regulation (ηp2 =0.49), behavioural regulation (ηp2=0.53), affective attitude (ηp2=0.23), identity (ηp2=0.24), and constructs of mindfulness (ηp2=0.44), and valued living (ηp2=0.20). CONCLUSIONS: Primary outcomes concerning feasibility were adequate and secondary outcomes improved, suggesting a full-scale randomized controlled trial is feasible with minor modifications. A large-scale study is warranted to establish intervention effectiveness.

PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial.

BACKGROUND: Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies. METHODS: PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT. DISCUSSION: We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence. TRIAL REGISTRATION: ISRCTN: 13,709,798; 15-Oct-2021.

Using FRAME to adapt an evidence-based dyadic intervention program for people living with dementia in residential aged care: A pilot feasibility study.

INTRODUCTION: The purpose of this study was to examine the feasibility of adapting and translating an evidence-based occupational therapist-delivered program shown to be effective in the community to residential aged care (RAC). The program aims to improve quality of care and quality of life for people living with dementia and the wellbeing of the family care partner. METHODS: This study took place in a not-for-profit RAC home in Adelaide, South Australia. Mixed methods, specifically questionnaires, activity logs, focus group, and one-on-one interviews were used to evaluate the feasibility of the program implementation. Staff working in the participating home, occupational therapists trained to deliver the program, and residents and their family carer partners were included. Quantitative data were analysed using proportions, means, and standard deviations. Qualitative data were analysed using a thematic approach. CONSUMER AND COMMUNITY INVOLVEMENT: This study was conducted together with a consumer (person living with dementia) and a carer representative (family member of someone residing in RAC). These representatives provided input towards the study design, interpretation of study data, discussion of results, and recommendations for future consideration. RESULTS: Small changes to the program improved feasibility and acceptability for delivery in RAC. While the care home staff required added support during implementation, the intervention therapists felt that the program could be delivered in this setting. Family care partners of residents with dementia felt that the program may be better suited if provided upon entry to RAC or in early stages of dementia. CONCLUSION: Adapting a community-based dementia care program to RAC can be safe and feasible. Program adaptations are necessary for feasibility. Further adaptations and evaluations of associated outcomes (related to residents with dementia and their family care partners) are needed to assess the program effectiveness in larger scale. PLAIN LANGUAGE SUMMARY: Spending quality time with family members in residential aged care is important. However, many struggle to know what to say or do when visiting a family member who lives with dementia. Programs that teach families about how to communicate with people living with dementia, how to support them to take part in important everyday living activities, or how to understand why changes in behaviours may occur have not been available in residential aged care. This paper describes how we adapted one such evidence-based program from community to residential aged care settings. We consulted with people living with dementia, carers, and families and found that the program could also be valuable in this care setting. Residential aged care staff described how the program is very different to what is usually available in residential aged care, but they were optimistic that with the right support, it could be a valuable way to support residents with dementia and their families. Family members of residents with dementia and therapists delivering the program felt that residents in early stages of living in residential aged care and/or early stages of dementia could benefit the most from these programs. We found that including family members in the intervention process can be useful and empowering for families and residents. Future work should also focus on involving other staff members caring for residents in the process. Communication between staff and families is the key for program delivery and success and treating each person as an individual.

A feasibility study to assess the recruitment and retention of pregnant patients who regularly use cannabis.

OBJECTIVE: To assess first-trimester recruitment and retention of pregnant patients who regularly used cannabis, but not other substances, measured by willingness to participate in a research study, completion of self-administered electronic questionnaires, and willingness to provide urine samples during each trimester of pregnancy. We designed and launched a prospective feasibility study titled, Cannabis Legalization in Michigan (CALM) - Maternal & Infant Health (MIH), in two Michigan clinics after the recreational use of cannabis became legal for adults 21 years and older. RESULTS: Over half (52%) of patients asked to participate in CALM-MIH were consented to the study. Two-thirds (66%) of screened patients initiated prenatal care during their first trimester of pregnancy and 50% used cannabis, of which the majority did not concurrently use other substances. Of those recruited into the prospective study, all participants completed the first-trimester questionnaire and provided urine samples. Study retention was 80% and all participants who completed follow-up assessments were willing to provide urine samples.

Evaluation of a knowledge-attitude-practice model based narrative life education program for community-dwelling older adults: a mixed-methods feasibility study.

BACKGROUND: The global aging population presents challenges that are particularly acute in China. Older Chinese adults' attitudes towards death significantly impact their quality of life. Death education is crucial for promoting positive perspectives on life and death. Narrative education offers a promising approach to facilitating death education. Integrating the Knowledge-Attitude-Practice (KAP) model into death education will enhance the feasibility and acceptability of death education programs. METHODS: This mixed-methods feasibility study included a quasi-experimental trial and semi-structured interviews. Older adults in the intervention group (N = 27) received a 6-week KAP-based narrative life education program in addition to standard community health education; participants in the control group (N = 20) received only the normal community health education. In both groups, attitudes toward death and the meaning of life were assessed at baseline and immediately after the intervention. A post-intervention semi-structured interview and satisfaction survey were also conducted for the intervention group. RESULTS: Forty out of 47 older adults completed the program for an 85.1% retention rate. All of the older adults in the experiment were very satisfied and satisfied with the life education program, and no adverse events were reported. Compared to the control group, participants in the intervention group had a significant decrease in the fear of death (P = 0.028), and substantial improvement in their value of life (P = 0.031), goal of life (P = 0.035), freedom of life (P = 0.003), and the total score for purpose in life (P = 0.017). The qualitative results yielded four themes: profound recognition of life and death, contradiction between thoughts and action, conflict between one's acceptance and others' avoidance, and evaluation of the life education program. CONCLUSIONS: The KAP-based narrative life education program is feasible and acceptable for older Chinese community-dwelling adults. It is also potentially effective in improving attitudes toward death attitudes and the meaning of life in this cohort. TRIAL REGISTRATION: This study was retrospectively registered at China Clinical Trial Registry as ChiCTR2300069551 on 2023-03-20. URL of registration: https://www.chictr.org.cn/showproj.html?proj=183176 .

Assessment of the Feasibility of Objective Parameters as Primary End Points for Patients Affected by Knee Osteoarthritis: Protocol for a Pilot, Open Noncontrolled Trial (:SMILE:).

BACKGROUND: Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired. OBJECTIVE: The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators). METHODS: This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits. RESULTS: Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024. CONCLUSIONS: The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product. TRIAL REGISTRATION: ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/13642.

The Feasibility and Efficacy of Remote App-Guided Home Exercises for Frozen Shoulder: A Pilot Study.

Home exercise programs are beneficial in managing frozen shoulder (FS), yet adherence remains challenging. This pilot study introduces the remote app, Defrozen, designed for home exercises and assesses its feasibility and clinical outcomes in FS patients undergoing intra-articular and sub-acromial corticosteroid treatment. Over a four-week period, patients used the Defrozen-app, engaging in guided exercises. The feasibility of the intervention was assessed through several measurement scales, including adherence, the Technology Acceptance Model 2 (TAM2), the System Usability Scale (SUS), and User Satisfaction and Engagement (USE). Clinical outcomes included pain scale, Oxford Shoulder Score (OSS), Quick Disability of the Arm, Shoulder, and Hand (QuickDASH) Score, and passive range of motion. The TAM2 results indicated high perceived usefulness (4.5/5), ease of use (4.8/5), and intention to use (4.4/5); the SUS score was high at 81.7/100, complemented by USE scores reflecting ease of learning (4.9/5) and satisfaction (4.3/5). Clinical outcomes showed significant pain reduction, improved shoulder function, reduced shoulder-related disability, and increased shoulder range of motion. These findings suggest the Defrozen-app as a promising solution for FS, significantly improving adherence and showing potential to enhance clinical outcomes. However, these clinical outcome results are preliminary and necessitate further validation through a large-scale randomized controlled trial to definitively confirm efficacy and assess long-term benefits.

Pilot Randomized Controlled Trial of Lymfit: A Theory-Guided Exercise Intervention for Young Adults with Lymphoma.

Despite the rapidly emerging evidence on the contributions of physical activity to improving cancer-related health outcomes, adherence to physical activity among young adults with lymphoma remains suboptimal. Guided by self-determination theory (SDT), the Lymfit intervention (a 12-week individualized exercise program with bi-weekly kinesiologist support and an activity tracker) aimed to foster autonomous motivation toward physical activity. This pilot randomized controlled trial aimed to evaluate the feasibility, acceptability, and preliminary effects of Lymfit. Young adults (N = 26; mean age of 32.1 years) with lymphoma who were newly diagnosed and those up to six months after completing treatment were recruited and randomly assigned one-to-one to either the intervention group (n = 13) or a wait-list control group (n = 13). All a priori feasibility benchmarks were met, confirming the feasibility of the study in terms of recruitment uptake, retention, questionnaire completion, intervention fidelity, missing data, Fitbit wear adherence, and control group design. The intervention acceptability assessment showed high ratings, with eight out of ten items receiving >80% high ratings. At post-intervention, an analysis of covariance models showed a clinically significant increase in self-reported physical activity levels, psychological need satisfaction, and exercise motivation in the intervention group compared to controls. Lymfit also led to meaningful changes in six quality-of-life domains in the intervention group, including anxiety, depression, fatigue, sleep disturbance, social roles and activities, and pain interference. The findings support Lymfit as a promising means to meet psychological needs and increase the autonomous motivation for physical activity in this group. A fully powered efficacy trial is warranted to assess the validity of these findings.

Dealing with couple infidelity in romantic relationships: A group intervention feasibility study.

The extent to which group therapy benefits individuals who have experienced couple infidelity remains unexamined. In this study, a brief group intervention for individuals who experienced couple infidelity was designed, and the feasibility of the intervention was evaluated (i.e., acceptability; implementation; measurements' performance and, limited-efficacy testing). The final sample was composed of 20 women and 4 men (M = 29.95 years, SD = 12.3). Twenty-four completed pre and post assessments and 20 of these completed the follow-up assessment. At pre, post, and follow-up, participants responded to a questionnaire packet that included measures of depression, anxiety and PTSD symptoms, relationship self-efficacy, centrality of event, cognitive fusion, and decision to forgive. Also, follow-up interviews were conducted. The closed group intervention consisted of eight 90-min weekly sessions. The group therapy process component was based on solution-focused therapy. Psychoeducation component included mindfulness, reflection on personal values, factors that contribute to infidelity, and forgiveness. Session rating scores indicated an overall high acceptance of the intervention, its contents, and goals. Interview reports showed that dealing with thoughts and emotions, understanding infidelity, and forgiveness were the most helpful contents. Group support and processes were also positively valued. Repeated-measures MANOVA results indicated statistically significant decrease in symptoms, cognitive fusion, and importance of the event, as well as an increase in self-efficacy. Measurement instruments showed adequate reliability. These results indicate that a group treatment may be an alternative format to help individuals deal with psychological consequences of couple infidelity, when couple therapy is not possible.

Silver diamine fluoride for the management of dental caries in children in primary dental care: protocol for a feasibility study.

BACKGROUND: Dental caries remains a significant problem in England, affecting 11% of 3-year-olds and 23% of 5-year-olds. While current approaches have been extensively investigated, their ability to (1) control pain and infection; (2) prevent hospital admissions, and (3) be implemented within the National Health Service (NHS) contractual arrangements, remains unsatisfactory. Silver diamine fluoride (SDF) is an alternative, non-invasive approach that has proven efficacy in arresting caries progression in primary teeth, principally from studies conducted outside of Europe. Its use in primary dental care in the UK is limited, despite the acknowledged need. The clinical and cost-effectiveness of SDF has not been compared to usual care in the UK. Before a pragmatic randomised controlled trial (RCT) can be conducted to compare SDF to usual care for caries management in young children, there are several uncertainties that require investigation. This study aims to establish whether such an RCT is feasible. METHODS: This mixed-method parallel design study is a feasibility study with an embedded process evaluation, to compare SDF with usual treatment in primary dental care in the UK. It will be individually randomised, with 13 dentists and therapists, in 8 different dental primary care sites with a sample size of 80 child participants aged 1-8 years old. The aim will be to recruit ten participants per site with equal arm allocation. Follow-up will be for 1 year. The study will inform whether an RCT is feasible by resolving several key uncertainties. The acceptability and implementation of SDF and the research processes will be explored. Patient and Public Involvement and Engagement representatives will be involved throughout recruitment and retention strategies, participant documentation, analysis, engagement and dissemination. DISCUSSION: The ability to conduct an RCT will be evaluated. If feasible, this RCT has the potential to evaluate the effectiveness of a non-invasive approach for the management of untreated caries in young children. A feasibility study also offers the opportunity to consider factors associated with the implementation of SDF at an early stage through a process evaluation that will inform the definitive trial and an implementation strategy for SDF by identifying relevant barriers and facilitators. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06092151. Date: 19/10/2023.

Exploring the potential of genetic analysis in historical blood spots for patients with iodine-deficient goiter and thyroid carcinomas in Switzerland and Germany (1929-1989).

Iodine deficiency-induced goiter continues to be a global public health concern, with varying manifestations based on geography, patient's age, and sex. To gain insights into clinical occurrences, a retrospective study analyzed medical records from patients with iodine deficiency-induced goiter or thyroid cancer who underwent surgery at the Community Hospital in Riehen, Switzerland, between 1929 and 1989. Despite today's adequate iodine supplementation, a significant risk for iodine-independent goiter remains in Switzerland, suggesting that genetic factors, among others, might be involved. Thus, a pilot study exploring the feasibility of genetic analysis of blood spots from these medical records was conducted to investigate and enhance the understanding of goiter development, potentially identify genetic variations, and explore the influence of dietary habits and other environmental stimuli on the disease.Blood prints from goiter patients' enlarged organs were collected per decade from medical records. These prints had been made by pressing, drawing, or tracing (i.e., pressed and drawn) the removed organs onto paper sheets. DNA analysis revealed that its yields varied more between the prints than between years. A considerable proportion of the samples exhibited substantial DNA degradation unrelated to sample collection time and DNA mixtures of different contributors. Thus, each goiter imprint must be individually evaluated and cannot be used to predict the success rate of genetic analysis in general. Collecting a large sample or the entire blood ablation for genetic analysis is recommended to mitigate potential insufficient DNA quantities. Researchers should also consider degradation and external biological compounds' impact on the genetic analysis of interest, with the dominant contributor anticipated to originate from the patient's blood.

Feasibility and acceptability of an online group dialectical behavioural therapy skills training in a Transdiagnostic group with Anxiety and Depression.

Transdiagnostic approaches offers a paradigm shift in managing psychiatric disorders. Emotion regulation difficulties are a transdiagnostic prevalent across various mood and personality disorders. Dialectical Behavioural Therapy Skills Training (DBT-ST), initially designed as part of treatment for borderline personality disorder, targets emotion regulation and has shown promise in diverse psychiatric conditions. In lower middle-income countries with resource-constrained settings, online delivery of evidence-based interventions holds potential to bridge treatment gaps. This study assesses the feasibility and acceptability of online group DBT skills training for individuals with depression or anxiety disorders in India. Mental health professionals practising in India referred twenty-four eligible participants currently not engaged in psychotherapy. Of these, 18 initiated the 8-week virtual group DBT-ST program, with 12 completing it (66 % female, 18-35 years of age, 5 on concurrent medication). They provided feedback on therapy content's usefulness. Baseline, post-intervention, and one-month follow-up assessments measured changes in emotion regulation difficulties, depression, and anxiety symptoms. Treatment retained 66.7 % of participants, all participants found the intervention beneficial. Repeated measures ANOVA indicates significant reductions in self-reported difficulties in emotion regulation, depression, and anxiety symptoms post-intervention. These findings highlight the promise of transdiagnostic interventions like DBT-ST that merit further evaluations using RCTs with larger sample sizes.

Development and feasibility of a mindfulness-based dance/movement therapy intervention for chronic low back pain.

Introduction: Responding to the need for innovative, multi-modal, non-pharmacological strategies in chronic low back pain (cLBP) care, this article presents the development and a mixed methods feasibility trial of a manualized Mindfulness-based Dance/Movement Therapy (M-DMT) program for cLBP. The 12-week program is designed as a group therapy, integrating mindfulness principles, creative/expressive dance and movement, and psychoeducational content focused on cLBP management. This holistic program seeks to cultivate nonjudgmental awareness of pain experiences, challenge maladaptive pain-related beliefs, enhance emotional well-being, foster social support, and promote effective coping strategies for the daily challenges associated with cLBP. Methods: The 12-week M-DMT intervention was administered to individuals with non-specific cLBP (N = 18, aged 51.7 ± 13.9 years, 72% female, 55% Black and 39% White). We assessed feasibility and acceptability through monitoring enrollment and retention rates, attendance, and adverse events. Moreover, we measured the intervention's credibility/expectancy, participants' perception of changes, and overall satisfaction. Additionally, we collected qualitative data, capturing participants' perspectives on the intervention's usefulness and perceived benefits. Specific benchmarks were established to gauge the successful feasibility and acceptability of the program. Results: The adherence rate stood at 80%, with a perfect retention rate of 100%. The study successfully met the benchmarks for treatment acceptability and satisfaction criteria, with 61% of participants reporting "feeling better" or a "great deal better" after the intervention. No adverse events were observed. Participants found the intervention enjoyable and reported that it provided effective tools for cLBP and related symptoms. Notably, participants reported a decrease in fear-avoidance behaviors, increased motivation for physical activity, and a boost in self-efficacy for pain management. Discussion: These encouraging findings establish a strong basis for considering the M-DMT intervention as a promising approach for cLBP management, warranting further investigation in larger-scale studies.

Feasibility and Inter-rater Reliability of the Japanese Version of the Intensive Care Unit Mobility Scale.

Purpose The purpose of this study was to verify the feasibility and inter-rater reliability of the Japanese version of the Intensive Care Unit Mobility Scale (IMS). Methods A prospective observational study was conducted at two intensive care units (ICUs) in Japan. The feasibility of the Japanese version of the IMS was assessed by 25 ICU staff (12 physical therapists and 13 nurses) using a 10-item questionnaire. Inter-rater reliability was assessed by two experienced physical therapists and two experienced nurses working with 100 ICU patients using the Japanese version of the IMS. Results In the questionnaire survey assessing feasibility, a high agreement rate was shown in 8 out of the 10 questions. All respondents could complete the IMS evaluation, and most respondents were able to complete the scoring of the IMS in a short time. The inter-rater reliability of the Japanese version of the IMS on the first day of physical therapy for ICU patients was 0.966 (95% CI: 9.94-9.99) for the weighted kappa coefficient and 0.985 (95% CI: 9.97-9.99) on the ICU discharge date assessment. The weighted κ coefficient showed an "almost perfect agreement" of 0.8 or higher. Conclusion The Japanese version of the IMS is a feasible tool with strong inter-rater reliability for the measurement of physical activity in ICU patients.

The LIVER CARE trial - screening for liver disease in individuals attending treatment for alcohol use disorder: a randomized controlled feasibility trial.

BACKGROUND: Alcohol-related liver disease is a preventable disease with high mortality. If individuals with alcohol-related liver disease were to be diagnosed earlier by screening and they reduced their alcohol consumption, lives lost to alcohol-related liver disease might be saved. A liver stiffness measurement (FibroScan©) is a key tool to screen for alcohol-related liver disease in asymptomatic individuals. No randomized controlled trials have been conducted to test if screening for liver disease reduces alcohol consumption in individuals with alcohol use disorders, in addition to what can be obtained by motivational interventions. We aimed to assess the feasibility of a randomized controlled trial of a screening for liver disease on the prevalence of alcohol abstinence or light consumption after 6 months in individuals attending outpatient treatment for alcohol use disorder. METHODS: We used an interdisciplinary approach to develop the format of the randomized controlled trial. Individuals were recruited from one outpatient treatment facility for alcohol use disorders. Study participants were randomized 1:1 to receive a) a liver stiffness measurement in addition to usual care (intervention) or b) usual care (control). Follow-up on alcohol consumption was assessed by telephone interview after 6 months and corroborated by data from records from public hospitals and the alcohol treatment facility. Feasibility was assessed by probabilities of recruitment, retention, and completion and estimated by the exact binominal test, with success defined as > 50% participation for each endpoint. The study design was evaluated at interdisciplinary meetings with staff and researchers from the outpatient alcohol treatment facility and the hospital clinic. RESULTS: Forty of 57 invited individuals agreed to participate in the study (recruitment = 70% (95% CI: 57-82)); 19 of 20 participants randomized to the intervention showed up for the screening (retention = 95% (95% CI: 75-100)). Follow-up telephone interviews succeeded for 33 of 39 reachable participants (completion = 85% (95% CI: 69-94)). Treatment records indicated that the 6 participants who were lost to follow-up for the telephone interview had not achieved alcohol abstinence or light consumption. There was no evidence that the intervention increased abstinence or light alcohol consumption at follow-up: 45% (95% CI: 23-68) in the intervention group and 65% (95% CI: 41-85) in the control group had a alcohol consumption below 10 standard drinks/week at 6 months. The main obstacle regarding study feasibility was to avoid disappointment in individuals randomized as controls. CONCLUSIONS: This feasibility study developed a study design to test the influence of screening for liver disease on abstinence or light alcohol consumption in individuals attending treatment for alcohol use disorder. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05244720; registered on February 17, 2022.

Transforming health care: Investigating Influenzer, a novel telemedicine-supported early discharge program for patients with lower respiratory tract infection: A non-randomized feasibility study.

BACKGROUND: The COVID-19 pandemic has posed unprecedented challenges to healthcare systems globally, necessitating innovative care models like hospital-at-home and virtual care programs. The Influenzer telemedicine program aims to deliver hospital-led monitoring and treatment to patients at home. Integrating telemedicine technology with domestic visits provides an alternative to traditional hospitalization, with the aim of easing the burden on healthcare facilities without compromising patient safety. To evaluate the effectiveness of the Influenzer program, a randomized controlled trial is proposed. This study aimed to assess the feasibility of the proposed clinical trial design. METHODS: A non-randomized feasibility study was conducted at the Department of Pulmonary and Infectious Diseases at Nordsjaellands Hospital offering a telemedicine-supported early discharge program to patients with lower respiratory tract infections, including COVID-19. The feasibility of trial procedures, including recruitment, adherence, and retention, was analyzed. Also, participants' characteristics and trajectory during the intervention, including telemedicine and domestic services, were assessed. RESULTS: Nineteen patients were enrolled from June 2022 to April 2023 and treated at home. Forty patients were not enrolled as 15 (25%) were non-eligible according to study protocol, 15 (25%) refused to participate and 10 (17%) had not been approached. Subjects treated at home had comparable clinical outcomes to those treated in the acute hospital, no major safety incidences occurred and patients were highly satisfied. Participants demonstrated 99% adherence to planned daily monitoring activities. In total, 63% completed all survey assessments at least partially including baseline, at discharge, and 3 months post-discharge, while 89% participated in a follow-up interview. No participants withdrew their consent. CONCLUSIONS: The feasibility study documented that the Influenzer home-hospital program was feasible and well accepted in a Scandinavian setting in terms of no withdrawals and excellent participant adherence to the planned daily monitoring activities. Challenges in the organizational structures including patient recruitment and data collection required resolution prior to our randomized clinical trial. Insights from this feasibility study have led to the improved design of the final Influenzer program evaluation trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05087082. Registered on 18 August 2021.

A Feasibility Study on Using Hanging Arm Test to Assess Elbow Stability During Surgical Treatment for Varus Posteromedial Rotatory Instability.

Objectives: The aim of this study to investigate the safety and effectiveness of performing the hanging arm test during surgical treatment for elbow varus posteromedial rotatory instability (VPMRI) to assess elbow stability and determine whether to repair the lateral ulnar collateral ligament (LUCL). Methods: In a retrospective study from August 2014 to March 2019, 27 patients with VPMRI who had a negative result in the hanging arm test after fixation of coronoid fracture were selected. Intraoperative bleeding, operative time, elbow range of motion (ROM), and complications were recorded. Elbow function was evaluated with the Mayo elbow performance score (MEPS) and the disabilities of the arm, shoulder, and hand (DASH) score. Results: The operation time was 85.9 ± 11.06 min (range 65-110). The intraoperative blood loss was 70.7 ± 9.31 ml (range 60-100). At the last follow-up, the elbow joint averaged 73.8° ± 2.931° in pronation, 78.9° ± 2.941° in supination, 7.2° ± 3.207° in extension, and 123.3° ± 6.651° in flexion. The MEPS score was 90.7 ± 4.36 (range 74-95), and the DASH score was 9.8 ± 2.58 (range 6.67-13.3). One patient presented with symptoms of ulnar nerve entrapment 2 months after operation and was treated with ulnar nerve release. The symptom of numbness went away completely 1 week after operation. No complications such as wound infection, arthritis, or chronic instability of the elbow were found in the other patients. Conclusion: Our findings suggest that not all VPMRI patients need the LUCL to be repaired, and the hanging arm test is a safe and reliable method to assess whether to repair the LUCL in the treatment of elbow VPMRI. Level of evidence: Level IV; Retrospective studies.

Eye-movement desensitisation and reprocessing therapy (EMDR) to prevent transition to psychosis in people with an at-risk mental state (ARMS): mixed method feasibility study.

BACKGROUND: Trauma plays an important role in the development of psychosis, but no studies have investigated whether a trauma-focused therapy could prevent psychosis. AIMS: This study aimed to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to prevent psychosis in people with an at-risk mental state (ARMS), using eye-movement desensitisation and reprocessing therapy (EMDR). METHOD: This started as a mixed-method randomised study comparing EMDR to treatment as usual but, as a result of low participant recruitment, was changed to a single-arm feasibility study. The proposed primary outcome for an RCT was transition to psychosis at 12-month follow-up. Data on secondary outcomes were also collected. Qualitative interviews were conducted with patients and therapists. RESULTS: Fourteen participants were recruited from the Early Intervention teams. Most people who expressed an interest in taking part attended an assessment to determine eligibility. All those eligible consented to take part. A total of 64% (7 of 11) of participants who were offered EMDR were followed up at 12 months. Of the 11 participants offered EMDR, one (11%, 95% CI: 0.2%, 48%) transitioned to psychosis. Nine patients and three therapists were interviewed. Participants who completed therapy (n = 4; mean 10.5 sessions) found EMDR helpful, but those who discontinued (n = 6; mean 5.2 sessions) said it had not benefitted them overall. Therapists said EMDR could be effective, although not for all patients. CONCLUSIONS: Future studies recruiting people with an ARMS to an RCT may need to extend recruitment beyond Early Intervention teams. Although some individuals found EMDR helpful, reasons for discontinuing need to be addressed in future studies.