A novel test and treat program for hepatitis C virus infection utilizing HCV core antigen testing, among police and general population, Islamabad, Pakistan, 2022.

Hepatitis C virus core antigen (HCVcAg) testing can simplify and decrease costs of HCV infection confirmation compared to molecular testing (nucleic acid testing). We piloted HCVcAg testing for the confirmation of active infection. The study was conducted during June through December 2022 among the police and the general population of Islamabad, Pakistan age 18 years and older. Initial screening for HCV antibody was conducted using a rapid diagnostic test (RDT) for all consenting participants. Those who tested positive had venous blood samples tested for HCVcAg, platelets and aspartate aminotransferase (AST). Persons with HCVcAg values ≥3 fmol/L were defined as viremic, and they were offered treatment with direct acting antiviral (DAA) medications, sofosbuvir and daclatasvir. Aspartate aminotransferase to platelet ratio index (APRI) was calculated for each HCV infected person, and those with an APRI score <1.5 received treatment for 12 weeks, while those with APRI ≥ to 1.5 received 24 weeks of treatment. A total of 15,628 persons were screened for anti-HCV using RDT and 643 (4.1%) tested positive. HCVcAg values of ≥3 fmol/L was found in 399/643 (62.1%), and all were offered and accepted treatment. Of those treated, 273/399 (68.4%) returned for a follow-up SVR and HCVcAg was not detected in 261/273, a 95.6% cure rate. The pilot study demonstrated the effectiveness of reaching and treating an urban population using RDT for screening and HCVcAg for confirmation of infection and test of cure.

The bruxism screener (BruxScreen): Development, pilot testing and face validity.

BACKGROUND: To assess awake and sleep bruxism, the Standardised Tool for the Assessment of Bruxism (STAB) is currently being developed. The STAB will be a comprehensive tool for the detailed assessment of bruxism behaviour itself as well as of its possible consequences, causes, and comorbid conditions. OBJECTIVE: Since the STAB cannot fully meet the 'A4 principle' for a bruxism assessment tool, i.e., being Accurate (reliable and valid), Applicable (feasible), Affordable (cost-effective), and Accessible (suitable for everyday clinical use), the Bruxism Screener (BruxScreen) has been developed to be used in large-scale epidemiological research projects and, especially, in general, dental practices. METHODS: The BruxScreen consists of two parts: a questionnaire (BruxScreen-Q) to be completed by patients, and a clinical assessment form (BruxScreen-C) to be completed by dentists. RESULTS: This paper describes the development of the BruxScreen and provides the outcomes of the pilot testing phase and the face validity assessment (i.e. that the first impressions of the tool indicate that it adequately reflects the construct to be measured). CONCLUSION: The resulting BruxScreen is considered ready for more profound psychometric testing in the general dental setting.

Developing and evaluating an evidence-based practice research competency enhancement program for clinical nurses in Korea: a pilot study.

BACKGROUND: Evidence-based practice (EBP) is crucial for delivering high-quality healthcare and effective self-care. Enhancing clinical nurses' research competencies through structured mentorship is key to the widespread application of EBP. This study evaluated a newly developed Research Competency Enhancement Program (RCEP), aimed at bolstering EBP among experienced nurses. METHODS: Conducted in a tertiary university hospital in Korea, this single-group study employed a pretest-post-test design and a mixed-methods approach. The RCEP involved 11 experienced clinical nurses in an 8-week intervention, featuring mentor-led workshops, interactive sessions, and resource-driven activities. Data were collected using the Evidence-Based Practice Beliefs Scale (EBPB), the Evidence-Based Practice Attitude Scale (EBPA), and the Research Practice Ability (RPA) tool, alongside qualitative feedback. These measures assessed the program's feasibility, acceptability, and preliminary effectiveness. RESULTS: The quantitative analysis indicated significant improvements in research competency post-intervention. Mean scores on the EBPB and RPA scales increased (Z = -2.53, p = .011; Z = -2.66, p = .008). Participants described the RCEP as inspirational and challenging, creating an environment conducive to research. Facilitators included mentor support and innovative learning tools, while barriers were internet connectivity and scheduling conflicts. Suggestions for improvement included more hands-on sessions, small team collaborations, and integration with academic institutions. CONCLUSION: The RCEP, facilitated by EBP mentors, significantly improved the research competencies and attitudes of clinical nurses towards EBP. The study underscores the importance of continual RCEP refinement, integrating structured, interactive, and collaborative elements to further empower nurses in evidence-based practice. The program shows promise in enhancing research competencies and fostering a commitment to EBP in clinical settings.

Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

A virtual, group-based mindfulness intervention for midlife and older women with low libido lowers sexual distress in a randomized controlled pilot study.

BACKGROUND: Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM: We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS: Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES: We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS: Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS: Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS: This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION: A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.

"I was never one of those people who just jumped right in for me": patient perspectives on self-advocacy training for women with advanced cancer.

PURPOSE: Patients with advanced cancer experience many complicated situations that can make self-advocacy (defined as the ability speak up for yourself in the face of a challenge) difficult. Few self-advocacy interventions exist, and most are atheoretical with minimal patient engagement. The purpose of this study is to describe participant perspectives of a novel, self-advocacy serious game intervention called Strong Together. METHODS: This was a qualitative cross-sectional descriptive study among women receiving cancer care at an academic cancer center within 3 months of an advanced gynecologic or breast cancer diagnosis. Participants randomized to receive the intervention completed one-on-one semi-structured interviews 3-months post Strong Together and had the option to share voice journals about their experiences. Inductive qualitative approaches were used to descriptively analyze transcripts and voice journals. Descriptive content analysis approaches were used to group similar codes together into themes summarizing participants' experiences engaging with the Strong Together intervention. RESULTS: Participants (N = 40) reported that the Strong Together intervention was acceptable, noting that it was realistic and reflective of their personal experiences. Overarching themes included seeing myself in most scenarios and wanting more content; giving me the go ahead to expect more; offering ideas for how to stand up for myself; reinforcing what I am already doing; and reminding me of what I have. Participants suggested adding additional content including diverse characters. CONCLUSION: This study demonstrated that women with advanced cancer were receptive to a self-advocacy skills-building intervention. Future research should explore the mechanisms linking serious games to learning and health outcomes.

Evaluation of an electronic clinical decision support system (DeSSBack) to improve low back pain management: a pilot cluster randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a common reason for primary care consultation; yet doctors often find managing it challenging. An electronic decision support system for LBP (DeSSBack) was developed based on an evidence-based risk stratification tool to improve the management of patients with LBP in a Malaysian primary care setting. This pilot study aimed to assess the feasibility, acceptability, and preliminary effectiveness of DeSSBack for the conduct of a future definitive trial. METHODS: A pilot cluster randomized controlled trial (cRCT) with qualitative interviews was conducted. Each primary care doctor was considered a cluster and randomized to either the control (usual practice) or intervention (DeSSBack) group. Patient outcomes including Roland-Morris Disability Questionnaire (RMDQ), Hospital Anxiety and Depression Scale, and a 10-point pain rating scale were measured at baseline and 2-month postintervention. The doctors in the intervention group were interviewed to explore feasibility and acceptability of using DeSSBack. RESULTS: Thirty-six patients with nonspecific LBP participated in this study (intervention n = 23; control n = 13). Fidelity was poor among patients but good among doctors. The RMDQ and anxiety score had medium effect sizes of 0.718 and 0.480, respectively. The effect sizes for pain score (0.070) and depression score were small (0.087). There was appreciable acceptability and satisfaction with use of DeSSBack, as it was helpful in facilitating thorough and standardized management, providing appropriate treatment plans based on risk stratification, improving consultation time, empowering patient-centred care, and easy to use. CONCLUSIONS: A future cRCT to evaluate the effectiveness of DeSSBack is feasible to be conducted in a primary care setting with minor modifications. DeSSBack was found useful by doctors and can be improved to enhance efficiency. TRIAL REGISTRATION: The protocol of the cluster randomized controlled trial was registered at ClinicalTrials.gov (NCT04959669).

Supporting professionals to implement integrated, person-centered care for people with chronic conditions: the TARGET pilot study.

OBJECTIVE: The TARGET program for integrated, person-centered care for people with chronic conditions offers primary care (PC) professionals a set of tools and trainings to actively engage in population segmentation and person-centered needs assessments (PCNAs). A pilot study was conducted to gain insight into the program's feasibility and acceptability, and identify preconditions for successful implementation. DESIGN AND SETTING: Seven Dutch PC practices participated in a half-year pilot study starting in August 2020. We performed a review of the population segmentation tool, observed four training sessions and 15 PCNAs, and interviewed 15 professionals and 12 patients. RESULTS: Regarding feasibility and acceptability, we found that the tools and trainings provided professionals with skills to use the segmentation tool and take a more coaching role in the well-appreciated PCNAs. Concerning implementation preconditions, we found that team commitment and network connections need improvement, although work pleasure increased and professionals generally wanted the program to continue. CONCLUSIONS: While the content of the TARGET program is supported by its users, the implementation process, for instance team commitment to the program, needs more attention in future upscaling efforts.

Key PointsTo implement integrated care in practice, primary care professionals (PCPs) need concrete tools, skills and confidence.PCPs consider the tools and trainings of the TARGET program as feasible and acceptable to organize integrated careTARGET's success depends on commitment from professionals to its implementation and the strength of ties with professionals in other domains.Based on qualitative insights, TARGET improves work pleasure and patient experience, but it takes time to decrease work pressure effectively.

Targeting Patients' Cognitive Load for Telehealth Video Visits Through Student-Delivered Helping Sessions at a United States Federally Qualified Health Center: Equity-Focused, Mixed Methods Pilot Intervention Study.

BACKGROUND: The task complexity involved in connecting to telehealth video visits may disproportionately impact health care access in populations already experiencing inequities. Human intermediaries can be a strategy for addressing health care access disparities by acting as technology helpers to reduce the cognitive load demands required to learn and use patient-facing telehealth technologies. OBJECTIVE: We conducted a cognitive load theory-informed pilot intervention involving warm accompaniment telehealth helping sessions with patients at a Federally Qualified Health Center (FQHC). We demonstrate how to design and report recruitment methods, reach, delivery process, and the preliminary impact of a novel equity-focused intervention. METHODS: Early into the COVID-19 pandemic a telehealth helping session was offered to patients at FQHC via phone. Graduate students led the sessions on conducting a telehealth video test run or helping with patient portal log-in. They systematically recorded their recruitment efforts, intervention observations, and daily reflection notes. Following the intervention, we asked the intervention participants to participate in an interview and all patients who had telehealth visits during and 4 weeks before and after the intervention period to complete a survey. Electronic health records were reviewed to assess telehealth visit format changes. Descriptive and inferential statistical analyses of the recruitment records, electronic health record data, and surveys were performed. Through integrative analysis, we developed process-related themes and recommendations for future equity-focused telehealth interventions. RESULTS: Of the 239 eligible patients, 34 (14.2%) completed the intervention and 3 (1.2%) completed subsequent interviews. The intervention participants who completed the survey (n=15) had lower education and less technological experience than the nonintervention survey participants (n=113). We identified 3 helping strategies for cognitive load reduction: providing step-by-step guidance for configuring and learning, building rapport to create confidence while problem-solving, and being on the same page to counter informational distractions. Intervention participants reported increased understanding but found that learning the video visit software was more difficult than nonintervention participants. A comparison of visit experiences did not find differences in difficulty (cognitive load measure) using telehealth-related technologies, changes to visit modality, or reported technical problems during the visit. However, the intervention participants were significantly less satisfied with the video visits. CONCLUSIONS: Although a limited number of people participated in the intervention, it may have reached individuals more likely to need technology assistance. We postulate that significant differences between intervention and nonintervention participants were rooted in baseline differences between the groups' education level, technology experience, and technology use frequency; however, small sample sizes limit conclusions. The barriers encountered during the intervention suggest that patients at FQHC may require both improved access to web-based technologies and human intermediary support to make telehealth video visits feasible. Future large, randomized, equity-focused studies should investigate blended strategies to facilitate video visit access.

Com-mens: a home-based logopaedic intervention program for communication problems between people with dementia and their caregivers - a single-group mixed-methods pilot study.

BACKGROUND: Communication difficulties are common in people with dementia, and often present from an early stage. However, direct treatment options for people with dementia that positively influence their daily communication are scarce. AIMS: To evaluate the potential impact and feasibility of a personalized logopaedic intervention. METHODS & PROCEDURES: A total of 40 community-dwelling persons with dementia and their caregivers were recruited. Five experienced speech and language therapists (SLTs) delivered the six-session Com-mens intervention at home. Com-mens aims to improve positive communication between people with dementia and their primary caregivers and comprises five elements: interactive history-taking, dynamic observational assessment, education about the consequences of dementia on communication, development and use of personalized communication tools, use motivational, and person-centred strategies by the SLT. We conducted a single-group mixed-methods pilot study with five measurements: baseline, directly after intervention, and at 3, 6 and 9 months follow-up. Semi-structured interviews and questionnaires for Experienced Communication in Dementia, quality of life, psychological well-being and caregiver burden were conducted. Process evaluation was performed by interviewing participants, drop-outs, SLTs and other stakeholders. OUTCOMES & RESULTS: A total of 32 dyads completed the intervention. Repeated measures analyses revealed no significant changes over time. In the interviews, participants reported a positive impact on their feelings, increased communication skills and better coping with the diagnosis. Participants would recommend the intervention to others. Facilitators were timely delivery, personalized content and adequate reimbursement. Barriers were unfamiliarity with Com-mens among referrers, an overburdened caregiver or disrupted family relationships. CONCLUSIONS & IMPLICATIONS: This newly developed logopaedic intervention is feasible and has a perceived positive impact on both people with dementia and their caregivers, which is confirmed by a stable pattern over a period of 1 year. Future comparative studies are needed to test the effectiveness of personalized interventions in this patient population. WHAT THIS PAPER ADDS: What is already known on the subject? SLTs are experts in the field of communication, but even though communication problems are common between people with dementia and their caregivers, there is a lack of logopaedic guidelines and materials for the direct treatment for this population. Interventions that are available either focus on (professional) caregivers only or aim to enhance cognitive functioning and do not target on joined communication. What this paper adds to the existing knowledge? A newly developed intervention called Com-mens can be provided by trained SLTs and takes an average of six 1-h sessions. The intervention is perceived to be valuable and feasible for people with dementia and their caregivers, by the participants themselves, as well as by healthcare professionals and other stakeholders. What are the potential or actual clinical implications of this work? Dissemination of this intervention will give SLTs skills, tools and materials to provide meaningful care to home-dwelling persons with dementia and their caregivers. Also, persons with dementia and their caregivers will receive education and materials that can help them increase their understanding of communication problems, enhance their communication skills and better cope with the communication problems that result from dementia. We consider the Com-mens intervention to be a valuable addition to the field of speech language therapy and dementia.

Development of the McMaster Embalming Scale (MES) to assess embalming solutions for surgical skills training.

Human cadavers used for surgical training are embalmed using various methods to facilitate tissue storage and longevity while preserving the natural characteristics required to achieve high fidelity functional task alignment. However, there are no standardized means to evaluate the suitability of embalming solutions for this purpose. The McMaster Embalming Scale (MES) was developed to assess the extent to which embalming solutions allow tissues to achieve physical and functional correspondence to clinical contexts. The MES follows a five-point Likert scale format and evaluates the effect of embalming solutions on tissue utility in seven domains. This study aims to determine the reliability and validity of the MES by presenting it to users after performing surgical skills on tissues embalmed using various solutions. A pilot study of the MES was conducted using porcine material. Surgical residents of all levels and faculty were recruited via the Surgical Foundations program at McMaster University. Porcine tissue was unembalmed (fresh- frozen) or embalmed using one of seven solutions identified in the literature. Participants were blinded to the embalming method as they completed four surgical skills on the tissue. After each performance, participants evaluated their experience using the MES. Internal consistency was evaluated using Cronbach's alpha. Domain to total correlations and a g-study were also conducted. Formalin-fixed tissue achieved the lowest average scores, while fresh frozen tissue achieved the highest. Tissues preserved using Surgical Reality Fluid (Trinity Fluids, LLC, Harsens Island, MI) achieved the highest scores among embalmed tissues. The Cronbach's alpha scores varied between 0.85 and 0.92, indicating a random sample of new raters would offer similar ratings using the MES. All domains except odor were positively correlated. The g-study indicated that the MES is able to differentiate between embalming solutions, but an individual rater's preference for certain tissue qualities also contributes to the variance in scores captured. This study evaluated the psychometric characteristics of the MES. Future steps to this investigation include validating the MES on human cadavers.

Feasibility of a repositioning schedule on pressure ulcer prevention in a French Intensive Care Unit: A pre and post-intervention pilot study.

AIMS: As a prerequisite of a multicentre study, we conducted a pilot study to assess the feasibility of a daily repositioning schedule in critically ill patients. The schedule was adapted to the patient's clinical condition, and the estimated risk for developing a pressure ulcer using the Braden scale. DESIGN: A single-center pre and post-intervention pilot study in a French Intensive Care Unit of a university teaching hospital. This study followed TREND guidelines. METHODS: During the first period (March to May 2018), pressure ulcer prevention was performed according to usual care. During the second period (June to August 2018), the repositioning schedule was adapted to the estimated risk for developing a pressure ulcer according to the Braden scale. Eligible patients had no pressure ulcer at baseline, were intubated within 24 hours of admission and expected to receive mechanical ventilation for at least 24 hours. The primary outcome was the rate of pressure ulcer development at 28 days of hospitalization or at discharge or death, as compared with usual care. Secondary outcomes included the feasibility and safety of the schedule, as assessed by caregivers' adherence and workload, and the rate of adverse events. RESULTS: In the pre-intervention period 20 participants were included, and 14 patients were included in the post-intervention period. There was no decrease in the pressure ulcers incidence with the intervention (25% vs. 28.6%; P = 1). The number of daily repositioning performed increased from 3.3 [IQR 3.0; 3.9] during the pre-intervention period to 4.3 [IQR 3.8; 5.2] during the post-intervention period (P < 0.05), where it differed from the number scheduled by 0.6 [IQR 0.1; 1.4] per day, indicating satisfactory adherence of caregivers to the protocol. Adverse events rate did not differ between the two periods (55.9% vs. 57.1%; P = 0.90). CONCLUSION: A personalised daily repositioning schedule in critically ill patients is feasible and safe. The efficacy of such a strategy, together with its economic impact, need to be assessed in a multicentre randomized trial.

A pilot randomized study of a telephone-based cognitive-behavioral stress-management intervention to reduce distress in phase 1 oncology trial caregivers.

OBJECTIVES: Caregivers of adult phase 1 oncology trial patients experience high levels of distress and face barriers to in-person supportive care. The Phase 1 Caregiver LifeLine (P1CaLL) pilot study assessed the feasibility, acceptability, and general impact of an individual telephone-based cognitive behavioral stress-management (CBSM) intervention for caregivers of phase I oncology trial patients. METHODS: The pilot study involved 4 weekly adapted CBSM sessions followed by participant randomization to 4 weekly cognitive behavioral therapy sessions or metta-meditation sessions. A mixed-methods design used quantitative data from 23 caregivers and qualitative data from 5 caregivers to examine the feasibility and acceptability outcomes. Feasibility was determined using recruitment, retention, and assessment completion rates. Acceptability was assessed with self-reported satisfaction with program content and participation barriers. Baseline to post-intervention changes in caregiver distress and other psychosocial outcomes were assessed for the 8-session intervention. RESULTS: The enrollment rate was 45.3%, which demonstrated limited feasibility based on an a priori criterion enrollment rate of 50%. Participants completed an average of 4.9 sessions, with 9/25 (36%) completing all sessions and an 84% assessment completion rate. Intervention acceptability was high, and participants found the sessions helpful in managing stress related to the phase 1 oncology trial patient experience. Participants showed reductions in worry and isolation and stress. SIGNIFICANCE OF RESULTS: The P1CaLL study demonstrated adequate acceptability and limited feasibility and provided data on the general impact of the intervention on caregiver distress and other psychosocial outcomes. Caregivers of phase 1 oncology trial patients would benefit from supportive care services; a telephone-based intervention may have more utilization and thus make a larger impact.

Peer-led alcohol intervention for college students: A pilot randomized controlled trial.

This study aims to assess the preliminary efficacy and feasibility of a brief, peer-led alcohol intervention to reduce alcohol consumption in binge-drinking Spanish nursing students. A pilot randomized controlled trial was conducted with 50 first-year nursing students who were randomly assigned either a 50-min peer-led motivational intervention with individual feedback or a control condition. Primary outcomes for testing the preliminary efficacy were alcohol use and alcohol-related consequences. Quantitative and content analyses of open-ended survey questions were performed. Participants in the intervention condition significantly reduced binge-drinking episodes, peak blood alcohol content, and consequences compared to the control group. Principal facilitators were completing the questionnaire during the academic schedule and providing tailored feedback through a graphic report. The main barrier was the unreliability of students' initial commitment. The findings suggest that a brief motivational intervention could be effective for reducing alcohol consumption and alcohol-related consequences in Spanish college students. Peer counselors and participants reported high satisfaction, indicating that the intervention is feasible. However, a full trial should be conducted taking into account the identified barriers and facilitators.

Pilot randomized psychosocial trial of a screening intervention in pediatric oncology.

OBJECTIVE: Psychosocial screening is a standard of care in pediatric oncology, but there is limited information about how to intervene after screening. This pilot trial aimed to determine feasibility of the novel Enhanced Psychosocial Screening Intervention (EPSI) and explore its preliminary efficacy outcomes. We examined rates of recruitment, retention, intervention acceptability, and monthly distress screening completion, as well as exploratory efficacy outcomes (Patient-Reported Outcomes Measurement Information System: depression, anxiety and fatigue; distress thermometer, pain and sleep). METHODS: Parallel-group randomized pilot trial: Caregiver-youth (10-17 years at enrollment, newly diagnosed with cancer) dyads were randomly allocated to either EPSI or standard care with 1:1 ratio allocation. EPSI consists of having a Psychosocial Navigator who shares screening results conducted near diagnosis and monthly for one year with treating teams and families, and provides recommendations tailored to screening results. RESULTS: Enrollment rate was 54% (38 dyads); retention was 90% and acceptability 86% (caregivers) and 76% (youth). Exploratory symptoms of depression, anxiety, distress and fatigue outcomes consistently improved mainly for caregivers. CONCLUSIONS: Results suggest EPSI is feasible and acceptable and exploratory mental and physical efficacy outcomes are promising for use in a future confirmatory multisite efficacy trial.

Targeting the link between social media and eating disorder risk: A randomized controlled pilot study.

OBJECTIVE: Evaluate the feasibility, acceptability, and preliminary efficacy of a self-criticism intervention addressing the link between appearance-motivated social media use and eating disorder risk. Another condition, designed to help users curate their social media feed to reduce negative impacts on wellbeing, was also trialed as an active and credible comparison. METHOD: University students aged 17-25 (N = 170) were screened and randomized (n = 130) to the self-criticism intervention, social media curation, or waitlist control group. The intervention comprised self-guided cognitive behavior therapy delivered in four modules over 1 week. Primary outcomes were feasibility and acceptability. Secondary outcomes were appearance motivations for social media use, appearance comparison, self-criticism, body image flexibility, and disordered eating (at baseline, one-week postrandomization, and two-weeks postrandomization). TRIAL REGISTRATION: ACTRN12621000353897. RESULTS: Participants completed an average of 82% of the intervention modules and 77% of the homework exercises within the week allocated. The intervention was well-accepted; participants reported a range of positive aspects, alongside suggested modifications to the intervention and study design to improve acceptability. Group by time interactions suggested groups changed at a different rate on three secondary outcomes; between-groups effect sizes suggested this was due to greater improvements in the self-criticism group than waitlist control. DISCUSSION: This was the first study to evaluate an intervention for the link between appearance-related social media use and eating disorder risk for young adults. Positive findings relating to feasibility, acceptability, and preliminary efficacy suggest a larger randomized controlled trial, with modifications to the intervention and study design, is warranted. PUBLIC SIGNIFICANCE: Appearance-related social media use has been linked to poorer body image and disordered eating, necessitating treatments that can disrupt this relationship. The self-criticism intervention evaluated in this study shows promise as a strategy to address this need. It is the first intervention focused on appearance-related social media use to be designed for and tested in young adults, who are at heightened risk of developing an eating disorder.

Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster-randomised trial.

There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent, leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment was 32% (95%CI 23-41%) in the intervention group vs. 81% (95%CI 70-90%) in the control group. The proportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control (31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference -0.6 units, 95%CI -1.2 to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3-1.1); and intensive care admissions (odds ratio 0.4, 95%CI 0.1-1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation.

Feasibility and acceptability of e-learning to upskill diabetes educators in supporting people experiencing diabetes distress: a pilot randomised controlled trial.

BACKGROUND: Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. METHODS: A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. RESULTS: Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health professionals) to supporting people with diabetes distress were common at baseline and follow-up.  CONCLUSIONS: The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

Dexmedetomidine for hyperactive delirium at the end of life: An open-label single arm pilot study with dose escalation in adult patients admitted to an inpatient palliative care unit.

BACKGROUND: Terminal delirium, specifically the hyperactive delirium subtype at the end of life, is common in palliative care patients. Standard care often involves sedation to alleviate distress. The alpha2-adrenoreceptor agonist dexmedetomidine may have promise in terminal delirium, due to its properties of decreasing delirium and permitting rousable sedation. AIM: This study aimed to describe the effect of dexmedetomidine on delirium and sedation, when delivered via continuous subcutaneous infusion (CSCI) in patients with terminal delirium. DESIGN: The trial was prospectively registered in the ANZCTR database (ACTRN12618000658213) and conducted in accordance with CONSORT (pilot study extension). Twenty-two adult patients were treated with a CSCI of dexmedetomidine with a two-tier dose schedule, low and high dose. Delirium severity was measured by the Memorial Delirium Assessment Scale (MDAS, target <13), and sedation by the Richmond Agitation-Sedation Scale, Palliative Version (RASS-PAL, target -1 to -3). RESULTS: All patients had a response to dexmedetomidine as measured by decrease in MDAS after initiation; 59% required escalation to high dose to maintain control of delirium. All responses to high dose were sustained. RASS-PAL scores showed significant variability, however mean scores remained within target range on both doses, and the majority of patients were rousable. Fifty percent of patients treated crossed over to standard care; no patients who crossed over were experiencing moderate-severe delirium. Predominant reason for crossover was family request for deeper sedation. CONCLUSION: Dexmedetomidine shows potential for the management of terminal delirium with improved interactivity. Further research is needed to determine efficacy compared to current standard care.

Accelerated repetitive transcranial magnetic stimulation in the treatment of post-concussion symptoms due to mild traumatic brain injury: a pilot study.

Objective: To investigate the feasibility, tolerability, and efficacy of twice-daily, low frequency (LF) repetitive transcranial magnetic stimulation (rTMS) over the right dorsolateral prefrontal cortex (DLPFC) in the reduction of chronic post-concussion symptoms (PCS) in patients who have suffered a mild traumatic brain injury (mTBI).Methods: 15 patients with mTBI received 30 sessions of twice-daily LF rTMS (1 Hz) over the right DLPFC. Post-concussion symptoms, pain, disability, fatigue, apathy, agitation, and mood were assessed by a psychiatrist pre- and post-treatment. Cognitive testing was also performed pre-, mid-, and post-rTMS.Results: All participants completed treatment with no serious adverse events. Significant improvements were observed in overall post-concussion symptoms, disability and pain ratings, as well as depression and anxiety symptoms. There was no significant change in overall executive functioning, fatigue severity, apathy, or agitation. Cognitive testing revealed improvements in verbal fluency, working memory, selective attention, and cognitive processing speed.Conclusions: This small-sample pilot study suggests that twice-daily, LF rTMS over the right DLPFC can be safely and tolerably applied and has the potential to improve post-concussion symptoms as well as elements of mood and cognition in patients with mTBI. Larger, sham-controlled studies will be important to confirm these observations.