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1.
Perspectives in Education ; 41(1):88-102, 2023.
Article in English | ProQuest Central | ID: covidwho-20245469

ABSTRACT

This study sought to investigate the impact of COVID-19-induced flexible work arrangements (FWAs) on gender differences in research outputs during COVID-19. A mixed research methodology was used, focusing on higher learning institutions in Zimbabwe. Purposive sampling was applied to select 250 researchers from the 21 registered universities in Zimbabwe. The study's findings revealed that institutions of higher learning in Zimbabwe did not provide the necessary affordances to enable both male and female academics to work from home effectively. The study also established that FWAs were preferred and appreciated by both male and female academics. However, whilst both male and female academics performed their teaching responsibilities without incident, unlike males, females struggled to find time for research, thus affecting professional growth and development negatively for female academics. Cultural traditions were found to subordinate females to domestic and caregiving responsibilities unrelated to their professions. The findings raise questions on the feasibility of the much-recommended FWAs for future work on female academics' research careers. Thus, without the necessary systems and processes to support female researchers, FWAs can only widen the gender gap in research outputs. This study contributes to the Zimbabwean higher learning institutions' perspective on how FWAs' policies and practices could be re-configured to assist female researchers in enhancing their research outputs as well as their career growth.

2.
Cancer Research Conference: American Association for Cancer Research Annual Meeting, ACCR ; 83(7 Supplement), 2023.
Article in English | EMBASE | ID: covidwho-20245051

ABSTRACT

mRNA is a new class of drugs that has the potential to revolutionize the treatment of brain tumors. Thanks to the COVID-19 mRNA vaccines and numerous therapy-based clinical trials, it is now clear that lipid nanoparticles (LNPs) are a clinically viable means to deliver RNA therapeutics. However, LNP-mediated mRNA delivery to brain tumors remains elusive. Over the past decade, numerous studies have shown that tumor cells communicate with each other via small extracellular vesicles, which are around 100 nm in diameter and consist of lipid bilayer membrane similar to synthetic lipidbased nanocarriers. We hypothesized that rationally designed LNPs based on extracellular vesicle mimicry would enable efficient delivery of RNA therapeutics to brain tumors without undue toxicity. We synthesized LNPs using four components similar to the formulation used in the mRNA COVID19 vaccines (Moderna and Pfizer): ionizable lipid, cholesterol, helper lipid and polyethylene glycol (PEG)-lipid. For the in vitro screen, we tested ten classes of helper lipids based on their abundance in extracellular vesicle membranes, commercial availability, and large-scale production feasibility while keeping rest of the LNP components unchanged. The transfection kinetics of GFP mRNA encapsulated in LNPs and doped with 16 mol% of helper lipids was tested using GL261, U87 and SIM-A9 cell lines. Several LNP formations resulted in stable transfection (upto 5 days) of GFP mRNA in all the cell lines tested in vitro. The successful LNP candidates (enabling >80% transfection efficacy) were then tested in vivo to deliver luciferase mRNA to brain tumors via intrathecal administration in a syngeneic glioblastoma (GBM) mouse model, which confirmed luciferase expression in brain tumors in the cortex. LNPs were then tested to deliver Cre recombinase mRNA in syngeneic GBM mouse model genetically modified to express tdTomato under LoxP marker cassette that enabled identification of LNP targeted cells. mRNA was successfully delivered to tumor cells (70-80% transfected) and a range of different cells in the tumor microenvironment, including tumor-associated macrophages (80-90% transfected), neurons (31- 40% transfected), neural stem cells (39-62% transfected), oligodendrocytes (70-80% transfected) and astrocytes (44-76% transfected). Then, LNP formulations were assessed for delivering Cas9 mRNA and CD81 sgRNA (model protein) in murine syngeneic GBM model to enable gene editing in brain tumor cells. Sanger sequencing showed that CRISPR-Cas9 editing was successful in ~94% of brain tumor cells in vivo. In conclusion, we have developed a library of safe LNPs that can transfect GBM cells in vivo with high efficacy. This technology can potentially be used to develop novel mRNA therapies for GBM by delivering single or multiple mRNAs and holds great potential as a tool to study brain tumor biology.

3.
Journal of the Intensive Care Society ; 24(1 Supplement):99, 2023.
Article in English | EMBASE | ID: covidwho-20244700

ABSTRACT

Introduction: Medical students receive relatively little exposure to intensive care medicine throughout their undergraduate training in comparison to other specialties. The COVID-19 pandemic further hindered students' exposure with entrance to intensive care units (ICU) limited to conserve personal protective equipment (PPE) and reduce the risk of virus spread. To address this problem, this study explored the use of assisted reality technology to create a smart classroom whereby medical students can experience intensive care medicine with the COVID-19 risks mitigated. There is existing literature describing the use of live streaming ward rounds using wearable technology to teach medical students, however, we believe this is the first time assisted reality technology has been harnessed to develop a teaching curriculum on intensive care.1 Objectives: This study aimed to assess the feasibility of using a wearable headset with assisted reality technology to live stream intensive care teaching to remotely based medical students. Method(s): Three intensive care teaching sessions were live streamed to three groups of medical students using the AMA XpertEye wearable glasses. The teaching session focused on the intensive care bed space and equipment as well as the assessment of a critically unwell intensive care patient. Two educators were required to facilitate the optimum learning environment. One educator wore the assisted reality technology glasses on the ICU whilst the other educator remained with the students to facilitate group discussion. The educators had the means to communicate via inbuilt technology on the glasses. Feedback from students was collected using the evaluation of technology-enhanced learning materials (ETELM).2 Results: The response rate for the ETELM survey was 100%. Students strongly agreed that the session was well organised, relevant and that the navigation of technology-based components was logical and efficient. 'There was a strong instructor presence and personal touch to the session' returned the strongest positive response. 'This session will change my practice' received the most varied response from students, potentially due to their stage in undergraduate training and distance from actual clinical practice. Students strongly disagreed that their learning was affected by technology issues. Educators reported problems with securing a patient appropriate to be involved alongside the busy clinical demands of the ICU. Facilitation by trained educators was crucial to ensure the teaching sessions were high quality. Conclusion(s): The use of smart classrooms on intensive care using assisted reality technology was very well received by medical students and educators. The main limitations included the necessity to balance the delivery of teaching alongside the clinical demands of the unit, however this is arguably the case with most forms of clinical teaching. There is the potential to continue using smart classrooms in the post-pandemic period, as they provide an open and safe platform for students to explore intensive care medicine and to ask questions that they may feel less able to raise in the busy clinical environment.

4.
Early Intervention in Psychiatry ; 17(Supplement 1):211, 2023.
Article in English | EMBASE | ID: covidwho-20244216

ABSTRACT

The DisCOVery study sought to better understand the experiences of young people with complex emerging mental health problems over the longer-term social restrictions related to the COVID-19 pandemic Quantitative findings (N = 105) will be shared to demonstrated how belonging to multiple social groups can promote better mental health through the provision of hopefulness and social connectedness. Qualitative findings (N = 16) will be shared to elucidate how young people with complex emerging mental health problems experienced social connectedness during the ongoing social restrictions, and how they perceive social connection to be associated with their well-being Results also indicate young people's social preferences and the complex role of in-person versus online connection and interaction. A brief summary will be given regarding a linked trial (TOGETHER), evaluating the feasibility of delivering a social connectedness-focused intervention for young people with emerging complex mental health problems across clinical and community services in the UK.

5.
Early Intervention in Psychiatry ; 17(Supplement 1):106, 2023.
Article in English | EMBASE | ID: covidwho-20244168

ABSTRACT

Aims: Trauma is particularly prevalent amongst Early Intervention (EI) patients and is associated with adverse clinical and prognostic outcomes. To determine the feasibility of a large-scale randomized controlled trial (RCT) of an 'EMDR for psychosis' intervention for trauma survivors with active psychotic symptoms supported by EI services, we conducted a single-blind RCT comparing 16 sessions of EMDRp + TAU versus TAU only. Method(s): EMDRp therapy and trial assessments were completed both in-person and remotely during the COVID-19 pandemic, and key feasibility outcomes (recruitment & retention, therapy attendance/ engagement, adherence to EMPRp treatment protocol, and the 'promise of efficacy' of EMDRp on relevant clinical outcomes) were examined at 6- and 12-month post-randomization assessments. Results and Conclusion(s): 60 participants (100% of the recruitment target) received TAU or EMDR + TAU. The feasibility criteria examined in this trial were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable post-treatment outcomes, including improved psychotic symptoms (PANSS), subjective recovery (QPR), post-traumatic symptoms (PCL-5;ITQ), depression (PHQ-9), anxiety (GAD-7) and general health status (EQ-5D-VAS) at the 6-month assessment. Signals of efficacy at 12-month were less pronounced, but remained robust for trauma symptoms and general health status. The findings will be discussed with relevance to future clinical trials of trauma-focused therapy in clients with early psychosis, and the provision of more tailored trauma therapies for EI service users.

6.
Transportation Research Procedia ; 69:600-607, 2023.
Article in English | Scopus | ID: covidwho-20244118

ABSTRACT

In transport infrastructure concessions, the sources of revenue to the private partner (or concessionaire) may include (i) the infrastructure users (e.g., landing fees, in the case of airports), (ii) the government (e.g. through availability payments), and (iii) both users and government, which might be called a hybrid concession. An example of the latter is a highway concession where the concessionaire charges tolls to the road users but, because of relatively low revenues, the government agency complements the toll revenue with availability payments. Focusing on airports, this paper summarizes the cases where it may be justified for the government to complement users' revenues and describes a model developed for the financial assessment of airport concessions involving payments by both the government and airport users, through the collection of several charges. The methodology described in the paper is also used to review the flexibility in new or ongoing airport concessions to mitigate traffic risks, which have been aggravated by the COVID-19 pandemic. The methodology can also be applied to other forms of transport infrastructure. A practical application of the model is demonstrated in the paper, using publicly available information, as well as basic assumptions, to build case studies for the Larnaca and Paphos airports in Cyprus. The model can also be used to carry out sensitivity analyses of the impact of key input parameters on outputs such as the investor's return on equity and annual debt service cover ratio. © 2023 The Authors. Published by ELSEVIER B.V.

7.
Journal of the Intensive Care Society ; 24(1 Supplement):72-73, 2023.
Article in English | EMBASE | ID: covidwho-20244033

ABSTRACT

Introduction: The need for standardised education on tracheostomy care is well recognised.1 Staff frequently report a lack of confidence in caring for those with tracheostomies, as well as the management of adverse events as they occur.2 Over the past decade, healthcare providers have developed strategies to educate staff, however, the covid-19 pandemic has severely hampered the ability to provide this necessary training due to restrictions on access to training rooms, the need for social distancing and the significant clinical demands placed on both trainers and trainees.3 The potential for immersive technologies to augment healthcare training is gaining interest exponentially.4 However, its effectiveness is yet to be clearly understood and as such it is not yet common within healthcare education.5 Based on the above, we aimed to explore the potential of these immersive technologies to overcome the current challenges of tracheostomy education, and to develop future strategies to use immersive technology in healthcare education. Method(s): We received a 400,000 grant from Cardiff Capital Region (CCR) to undertake a rapid innovation project overseen by the SBRI centre of excellence. The project consisted of 3 main phases: 1) feasibility;2) development;and 3) testing. The project was officially launched in April 2021 and lasted 12 months. Project governance was provided via the SBRI for clinical excellence, a project board with representation from Welsh Government, Cardiff University and Cardiff and Vale UHB, and a project team with clinical expertise in both the delivery of tracheostomy education and the provision of simulation training in healthcare. Result(s): Phase 1: During phase one 4 industries were successful and received up to 30,000 to explore the feasibility of immersive technology to support tracheostomy education. The industries were Rescape, TruCorp, Aspire2Be and Nudge Reality. During the feasibility phase all industries focused on the emergency management process utilising existing NHS Wales tracheostomy education resources and the national tracheostomy safety programme. Phase 2: For phase 2, Rescape and Nudge Reality were chosen to develop the technology. These industries continued to work in conjunction with the project team to capture the core elements of tracheostomy care, including multi-user emergency management scenarios. Additional content was also added for bronchoscopy and insertion of intercostal drains. Phase 3: Testing of both solutions was undertaken over an 8-week period, across 6 Health Boards in NHS Wales. The results of the testing will be analysed and available for presentation in due course. Provision findings demonstrate good face and content validity with high levels of user satisfaction. Discussion / Conclusion(s): The provision of essential tracheostomy education has been severely affected by the covid-19 pandemic. Evolving immersive technologies have the potential to overcome these challenges and improve the effectiveness and efficiency of education packages in tracheostomy care and wider. Through this CCR grant, in conjunction with industry, we have developed two solutions with the potential for widescale procurement and future research on the use of immersive technologies within healthcare.

8.
Applied Clinical Trials ; 31(5):10-13, 2022.
Article in English | ProQuest Central | ID: covidwho-20243334

ABSTRACT

Clinical trial patient recruitment is arguably the most difficult aspect of pharmaceutical development, because it involves a variety of factors beyond study sponsors' control. The aggregation of data across 80 hospitals and 20 systems, for the purpose of understanding patients, doing feasibility studies, or engaging in decentralized recruitment, is the trend we're seeing." Nimita Limaye, PhD, is the vice president of research for the life sciences R&D strategy and technology division at the International Data Corporation (IDC), a market research and advisory firm specializing in the technology industry and headquartered in Boston, Mass. Limaye says the rise of social media-based patient recruitment has opened the door for sponsors and investigators to mine real-world data and to give patients a more central focus in research.

9.
Journal of the Intensive Care Society ; 24(1 Supplement):71-72, 2023.
Article in English | EMBASE | ID: covidwho-20243070

ABSTRACT

Introduction: In common with many aspects of critical illness recovery, there is no universally accepted formula for "weaning," the term used to describe the process of liberating patients from mechanical ventilation.1-3 Understanding a patient's progress during a prolonged wean can be difficult and requires integration of various datasets. Therefore, it is good practice to ensure that weaning prescriptions are clear, easy to follow and adhered to and that weaning-associated data and meta data are recorded accurately and are easy to interpret. The prototype Digitally Enhanced Liberation from VEntilation (DELVE) system has been designed to be used in combination with the Puritan Bennett(TM) 980 (PB980) ventilator (Covidien, USA). DELVE is an open-loop system which provides an interactive weaning chart, combining the weaning prescription entered by the clinical staff, with actual settings recorded from the ventilator in order to display compliance with the prescription (Figure 1). DELVE also collects measured data from the ventilator which could be used to display respiratory performance, both real-time and historical. Figure 1. DELVE set up with the PB980 ventilator (in the simulation suite). Objective(s): This feasibility study was designed to inform development of the first DELVE prototype and a future clinical trial to determine clinical effectiveness and usefulness. The study objectives were to determine whether DELVE could: 1. Present a digital weaning chart that staff could use effectively and would be superior to the current paper version. 2. Record and display the patients' ventilatory performance, both real time and historical, during liberation from mechanical ventilation. Method(s): This was a mixed-methods, prospective feasibility study of a complex intervention.4 Ventilated patients with a tracheostomy, commencing the weaning process, were recruited from an adult intensive care unit. DELVE was used alongside the current paper-based system for weaning planning and data collection. Patients remained in the study until they no longer required the support of the PB980 ventilator. Result(s): Twenty patients were enrolled for between 25 and 270 hours each. There were no safety incidents or data breaches. DELVE was successfully operated by staff, who were able to connect DELVE to the ventilator, prescribe weaning plans and analyse adherence. The digital weaning chart user interface was intuitive and easy to navigate. It was clearer, more complete and easier to interpret when compared to the paper weaning charts (Figure 2). DELVE reliably collected data every ten seconds and safely stored over six million items of measured data and 25000 events, such as alarm triggers and setting changes, in a form that could allow analysis and pictorial or graphical presentation. Conclusion(s): This study supported the feasibility of this and future versions of DELVE to present both a digital weaning chart and to facilitate visual and numerical data presentation. Future iterations of the system could include a user-friendly dashboard representing patient progress during the weaning process. Assimilation of large volumes of data could be used to enhance understanding and inform decision making around the prolonged wean.

10.
Nervenheilkunde ; 42(5):263-272, 2023.
Article in German | EMBASE | ID: covidwho-20242542

ABSTRACT

About 10 % of all symptomatic COVID-19 patients suffer from long-lasting health complaints. Fatigue, cognitive and emotional disorders are the most frequent neuropsychiatric symptoms. Evidence-based therapies for these post-covid impairments are still lacking. Here, we examined the feasibility of a newly developed group-therapy program for patients with fatigue, emotional and cognitive disorders following COVID-19. 24 patients with ICD-10 diagnosis of F06.8 and U0.09 participated in the group therapy on average 13 month after their acute COVID-19 infection. Before and after the group therapy they underwent a comprehensive clinical and neuropsychological assessment. The group therapy was held online and consisted of 8 weekly sessions with psychotherapeutic and psychoeducational elements regarding fatigue and pacing, mindfulness, psychiatric disorders, cognition as well as physical activity after COVID-19. Participation in the group was high with an average of 7.25 of 8 visited sessions. Mean overall group satisfaction was 7.78 out of 10 points. Patients improved in their self-reported fatigue, daily living skills, depression and subjective cognitive abilities as well as in their objective performance in neuropsychological tests of attention during the study time. The newly developed group therapy program for patients with fatigue and emotional and cognitive disorders following an infection with SARS-CoV-2 was well accepted and evaluated and is feasible in an online setting. Copyright © 2023. Thieme. All rights reserved.

11.
Neuromodulation ; 26(4 Supplement):S51-S52, 2023.
Article in English | EMBASE | ID: covidwho-20241429

ABSTRACT

Introduction: There is a distinct unmet need in structured, curriculum based, unbiased education in neuromodulation. Current teaching is through sporadic industry workshops, cadaver courses and peer proctorship. The COVID pandemic has created a unique opportunity where online platforms have enabled education to be delivered remotely in both synchronous and asynchronously. The William Harvey Research Institute, Queen Mary University, London, UK have initiated University based accreditation- Post Graduate Certificate in neuromodulation (PGCert) that provides candidate a qualification in one academic year through part-time study. Method(s): The program underwent rigorous staged university approval process (figure 1). To ensure market feasibility, two short proof of concept CPD programs "Executive Education in Neuromodulation (EEPIN)" were delivered in 2021. These courses attracted 87 candidates across Australia, Singapore, India, Germany, Poland, Czech Republic, Ireland, and UK. The faculty includes key opinion leaders that will deliver the program ensuring the candidates gain academic background and specialist skills to understand safe practice of neuromodulation. The PGCert advisory board has been established to ensure strict governance in terms of content and unbiased delivery confirming ACCME guidance. In order to obtain PGCert, candidates are required to complete 4 x 15 credit modules (60 credits). The four modules include Anatomy & Neurophysiology;Patient care and Procedurals skills;Devices and available technology;Intrathecal drug delivery for cancer and non-cancer pain. The modular nature of the program is designed to provide cumulative knowledge, from basic science to clinical application in line with the best available evidence. The modules comprise nine lectures, spreading over three consecutive days, followed by a written assignment with 40 direct contact hours in each module. The webpage can be accessed at Results: The anonymous data from EEPIN reported on Likert scale 1-5: Objectives defined 30.6% - 4 and 69.4% -5;Relevance of topics 10.2%- 4 and 89.8% -5;Content of presentations 22.4%- 4 and 77.6% -5;Organization 24.5% -4 and 69.4% -5;Candidate faculty interaction 14.3% -4 and 81.6% -5. 97% of the EEPIN candidates recommended the program to others whilst 81.8% expressed their strong interest to enroll for university-based post graduate qualification if offered. Conclusion(s): This PGcert Neuromodulation is a unique, university accredited program that provides qualification in neuromodulation with access to a flexible online e-learning platform to discuss and exchange ideas, share knowledge in candidate's own time. This will support the ongoing need for formal curriculum-based education in neuromodulation. Disclosure: Kavita Poply, PHD: None, Phillippe Rigoard: None, Jan Kallewaard, MD/PhD: None, FRANK J.P.M. HUYGEN, MD PhD: ABBOTT: Speakers Bureau:, Saluda: Consulting Fee:, Boston Scientific: Consulting Fee:, Grunenthal: Speakers Bureau:, Pfizer: Speakers Bureau:, Ashish Gulve, FRCA, FFPMRCA, FFPMCAI, DPMed, FCARCSI, MD, MBBS: None, Ganesan Baranidharan, FRCA: None, Sam ELDABE, MD, FRCA, FFPMRCA: Medtronic: Consulting Fee:, Medtronic: Contracted Research:, Mainstay Medical: Consulting Fee:, Saluda Medical: Consulting Fee:, Boston Scientific: Contracted Research:, Saluda Medical: Contracted Research:, James Fitzgerald, MA,PhD: St Jude Medical: Consultant: Self, Medtronic: Consulting Fee:, UCB: Contracted Research:, Merck: Contracted Research:, Serge Nikolic, MD: None, Stana Bojanic, BSc MBBS FRCS (SN): Abbott: Contracted Research:, Habib Ellamushi: None, Paresh Doshi, MS MCh: None, Preeti Doshi, MBBS, MD, FRCA: None, Babita Ghai, MBBS, MD, DNB: None, Marc Russo, MD: Presidio Medical: Ownership Interest:, Saluda Medical: Ownership Interest:, Boston Scientific: Contracted Research: Self, Mainstay Medical: Contracted Research: Self, Medtronic: Contracted Research: Self, Nevro: Contracted Research: Self, Saluda Medical: Contracted Research: Self, Presidio Medical: Contracted Research: Self, Freedom Ne ro: Ownership Interest - Own Stocks: Self, Lungpacer: Ownership Interest - Own Stocks: Self, SPR Therapeutics: Ownership Interest - Own Stocks: Self, Lawrence Poree, MD,MPH,PHD: Medtronic: Consulting Fee: Self, Saluda Medical: Contracted Research: Family, Nalu Medical: Contracted Research: Family, Gimer Medical: Consulting Fee: Self, Nalu Medical: Consulting Fee: Self, Saluda Medical: Consulting Fee: Self, Nalu: Ownership Interest:, Saluda Inc: Ownership Interest:, Alia Ahmad: None, Alaa Abd Sayed, MD: Medtronic, Abbott, SPR and StimWave: Consulting Fee:, Salim Hayek, MD,PhD: None, CHRISTOPHER GILLIGAN, MD MBA: Persica: Consulting Fee: Self, Saluda: Consulting Fee: Self, Mainstay Medical: Contracted Research: Self, Sollis Therapeutics: Contracted Research: Self, Iliad Lifesciences, LLC: Owner: individuals with legal ownership in a company:, Vivek Mehta: NoneCopyright © 2023

12.
Journal of the American College of Surgeons ; 236(5 Supplement 3):S83-S84, 2023.
Article in English | EMBASE | ID: covidwho-20240803

ABSTRACT

Introduction: Since COVID-19 spurred transitions from in-person to virtual telehealth visits, Press Ganey scores across adult specialties have shown improved patient satisfaction. The impact of telehealth on the pediatric surgery population, however, has not been characterized. This study aims to evaluate telehealth feasibility in pediatric surgery by examining Press Ganey surveys from the largest pediatric surgery telehealth group in the US. Method(s): Demographics were extracted from medical records of patients evaluated by general pediatric surgeons at a tertiary pediatric center from January to September of 2019 and 2021. Customized Press Ganey results were compared between in-person and telehealth patients. Ratings were categorized as satisfied (good, very good) or not satisfied (very poor, poor, fair). Analysis was performed using two-sample t-test or Fisher's Chi- Squared test. Result(s): In 2019, 7,965 (99.9%) patients were evaluated in-person and 3 by telehealth. In 2021, 8,454 (77%) were evaluated in-person and 2,514 (23%) by telehealth. Telehealth patients were more likely to no-show (11.2% vs 6.1%,p<0.01) and leave without being seen (1.4% vs 0.02%,p<0.01). Spanish speakers attended more in-person visits than telehealth (14% vs 8%,p<0.001). In 2021, telehealth patients reported greater satisfaction with providers and greater likelihood of recommending their provider. Conclusion(s): This study demonstrates improvement in patient satisfaction with telehealth implementation in a large pediatric surgery cohort. However, our data suggest that there may be access to care issues that can be optimized. Lessons from this study may be translated to other surgical disciplines and used to improve access to care and patient satisfaction.

13.
Applied Clinical Trials ; 30(4):14-17, 2021.
Article in English | ProQuest Central | ID: covidwho-20240471

ABSTRACT

[...]this critical step is receiving the attention it deserves, maybe even an overhaul, as the wave of clinical trial decentralization surges on. With this regulatory foundation, the site feasibility process involves choosing sites that not only conform to these requirements, but can also offer the best fit for specific studies, based on past performance, access to a database of appropriate patients, and the bandwidth to perform the study at hand. A recent article by Kurbegov et al. of the American Society of Cancer Oncology (ASCO) describes a Task Force that was convened to evaluate the burdens and challenges of site feasibility, which often lead to delayed study start-up and act as a barrier to site participation.6 With input from sites, sponsors, and CROs in the form of surveys and in-person meetings, the Task Force developed three recommendations for improvement, with a goal of speeding patient access to clinical trial participation, and ultimately, much needed new treatments, as shown in Table 1 on the facing page. According to Comis, "We now have 146,000 users of SIP, which represents 125,000 site researchers.

14.
Annals of the Rheumatic Diseases ; 82(Suppl 1):934, 2023.
Article in English | ProQuest Central | ID: covidwho-20239627

ABSTRACT

BackgroundPeriodic follow-up (FU) is necessary for patients with Rheumatic Diseases (RDs). In the case of a stable clinical condition or low disease activity, FU can be carried out also by rheumatology nurses (RNs). Recent studies focusing on FUs led by RNs either in Rheumatology Clinics and with Telenursing (TN), showed promising results in terms of outcomes, cost reduction and users' satisfaction.ObjectivesTo evaluate the feasibility of a Telenursing FU in a Rheumatology Centre in Florence, Italy.MethodsIn this pilot study, patients with stable inflammatory arthritis or low disease activity were contacted, after their first visit, through TN (T0) and then assessed during the following in-person visit (V12) by RNs for treatment adherence, for pain, for mental and physical health, for workability, for perception of disease activity and satisfaction concerning the TN service.ResultsOut of 27 interviewed patients, 59.3% (n=16/27) was affected by Rheumatoid Arthritis (RA), 18.5% (n=5/27) by Spondyloarthritis (AS), 14.8% (n=4/27) by Psoriatic Arthritis (PsA) and 7.4% (n=2/27) by Juvenile Idiopathic Arthritis. The mean age was 57.5±13.1 (M± DS) years and the treatment adherence level was optimal. 11.1% (n=3/27) of patients was referred for medical consultation because of the urgent clinical situation assessed by the RNs according to the clinical multidisciplinary checklist. After specialist consultation, 1 patient was revalued in presence for a transient ischemic attack;1 patient was contacted by the rheumatologist following independent discontinuation of methotrexate therapy;1 patient was redirected to urgent dermatology consultation because of a suspected cutaneous drug reaction.During the TN period (12 months), 33.3% (n=9/27) of the patients contracted SARS-CoV-2 infection and 11.1% (n=3/27) contracted urinary or upper respiratory tract infections.RA patients showed a mean Rheumatoid Arthritis Impact of Disease-RAID score of 2.4 at T0 and 2.5 at V12 (Range 0-10);AS patients showed a mean Assessment of Spondyloarthritis International Society-ASAS score of 0.3 in both periods and PsA showed a mean Psoriatic Arthritis Impact of Disease-PSAID score of 0.7 and 0.8 at T0 and V12, respectively. Among RA, AS and PsA patients, as a pain score of 3 was recorded in both periods.In order to attend the in-person FU visit, 68.4% (n=13/19) of the patients took work leave. 37% (n=10/27) of them waited 40.9±18.6 minutes at V12 control. The average distance between the Rheumatology Centre and patients' home was 29.3±25.6 km. 15.4% (n=5/13) of the respondents did not own a car and 23.1% (n=3/13) was accompanied to visit by their caregiver.All the included patients expressed high satisfaction for the TN service, corresponding to 5 point Likert scale.ConclusionThe data show that TN FU is a valuable model for maintaining an adequate level of therapeutic adherence, reducing the travel time and working day loss, intercepting remotely clinical issues, as well as registering a high level of user acceptance and satisfaction. Further studies on larger samples are needed to confirm our findings.References[1] Bech B et al (2020) 2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Annals of the Rheumatic Diseases;79:61-68. doi: 10.1136/annrheumdis-2019-215458.[2] Alcazar B, Ambrosio L. (2019) Tele-nursing in patients with chronic illness: a systematic review. An Sist Sanit Navar;42(2):187-197. doi: 10.23938/ASSN.0645.[3] Larsson I et al. (2013) Randomized controlled trial of a nurse-led rheumatology clinic for monitoring biological therapy. Journal of Advanced Nursing;70(1), 164–175., 2013 doi:10.1111/jan.12183Acknowledgements:NIL.Disclosure of InterestsNone Declared.

15.
Blood Purification ; 51(Supplement 3):21, 2022.
Article in English | EMBASE | ID: covidwho-20239415

ABSTRACT

Background/aims: Controlled DCD organ donation (cDCD) is a strategic target for the Italian transplantation network. Italian peculiarities in cDCD donation make published results questionable and raise concern over organ ischemic damage. Consequently, normothermic regional perfusion (NRP) has been strongly recommended in potential cDCD donors. In 2019 the randomized multicenter DONARE study was designed to describe ischemic-reperfusion and inflammatory biomarkers during NRP and to test the potential benefit of apheresis by an adsorbent filter (CytoSorb) included in the NRP circuit. The aim of this report is to describe the modulation of the clinical characteristics and of the NRP in the DONARE study enrolled cases. Method(s): The study protocol was defined by the DCD national working group and proposed to all the Italian DCD donation centers. The coordinating center (CNT) has monitored the evolving cDCD activity to preserve the study capacity of representing the Italian scenario. Samples have been blindly centralized to an independent laboratory for cytokines profiling. The outcomes of transplanted organs have been recorded in the national quality database. Result(s): From September 2020 to June 2022, 27 out of the 40 planned cases have been enrolled in six centers: 4 in 2020, 12 in 2021 and 11 within June 2022. Approval is still pending in other centers. Main causes of exclusion among potential cDCD donors were: age above 65 (in 2020), e-CPR prior- to-death, shortage in personnel and COVID-19 restrictions. The age limit for enrolment (<65yrs) was abolished by amendment due to the national trend: mean age of enrolled cases increased from 57+/-6 in 2020 to 67+/-6 years in 2022. Mean NRP duration decreased from 223,3+/-39,2 in 2020 to 168,9+/-42,6 minutes in 2022;serial samples (4/2 with/without Cytosorb, from T0 to T4) from different points of the NRP circuit have been completed throughout the procedure in all the cases. All the enrolled cases became utilized donors. No study-related adverse event has been reported. Conclusion(s): Coordination of multicenter studies in the rapidly evolving scenario of controlled DCD donation should take advantage of continuous monitoring of real-life procedures and auditing of adherence to operational recommendations. The interim evaluation confirms the feasibility and safety of the study.

16.
European Journal of Housing Policy ; 23(2):338-361, 2023.
Article in English | ProQuest Central | ID: covidwho-20239381

ABSTRACT

COVID-19 has generated many problems and some opportunities in the housing market. The potential role of privately-owned short-term lets meeting specialist family violence crisis accommodation demand is one such opportunity. This paper engages with an important and increasing practice in the Australian context, of the utilisation of private housing stock as a component part of a public housing crisis response system, in this case explored in relation to domestic and family violence. In seeking to gain insights into the feasibility of this practice, this article will first frame mixed public/private accommodation provision as potentially overlapping relations between a thin territory of insufficient crisis infrastructure and a thick territory of commodified short-term let infrastructure. Second, this paper situates the potential of this intersection of mixed private/public responses in terms of riskscapes by unpacking how risk is perceived within these contested territories. The findings highlight tensions between both real and perceived understandings of safety, housing, wellbeing, economic and political risks. While there was some support for utilising short-term lets for crisis accommodation, barriers were revealed to adding thickness to the crisis accommodation space. Given increasing homelessness in Australia, diversifying crisis models could offer increased violence-prevention infrastructure to support women.

17.
Blood Purification ; 51(Supplement 3):68, 2022.
Article in English | EMBASE | ID: covidwho-20238908

ABSTRACT

Background: COVID-19 syndrome is associated with high morbidity and mortality in haemodialyzed patients. Pancreatic Stone Protein (PSP) is an early biomarker of sepsis and a prognostic biomarker of disease severity in critically-ill patients and can be rapidly measured at the patient's bedside with a point-of-care-test from a small drop of whole blood. The aim of our pilot was to investigate PSP in patients requiring haemodialysis with SARS-CoV-2 infection, at different severities of COVID-19 disease. Method(s): Between February and July 2021, 23 patients (6 severe COVID-19 with Acute Kidney Injury, 6 moderate COVID-19 haemodialyzed, 2 haemodialyzed without COVID-19 and 3 healthy controls) were recruited at the University Hospital of Foggia for PSP evaluation. Biomarker's measurements were performed within 48 hours after admission or upon arrival for haemodialysis (pre-treatment). PSP was measured at the patient's bedside with "abioSCOPE", a point-of-care test capable of evaluating PSP levels in five minutes from a small drop (50mul) of whole blood or serum. Result(s): The preliminary results of this pilot study showed a trend for PSP to increase along with the severity of disease. In fact, serum PSP levels were significantly higher in Intensive Care Unit subjects than in COVID-19 negative haemodialysis subjects and controls (ANOVA p=0.032). Furthermore, PSP levels were significantly higher in subjects who died (p<0.017). Whether this increase is due to the kidney injury or COVID-19 disease remains unknown, and more research is needed to understand the relationship. Conclusion(s): Several clinical studies published in literature have shown the predictive value of PSP in the early identification of sepsis and severity of the clinical outcome. In our experience we have seen a trend for PSP to increase with disease severity also in COVID-19 patients. These results are preliminary, but PSP was significantly higher in patients who died, in accordance with the literature. This experience also has demonstrated the feasibility of a point of care system to be easily implemented in the unit and adopted by personnel and its design enables fast results and immediate decisions to be taken, especially in urgent situations.

18.
Drug Evaluation Research ; 44(7):1568-1572, 2021.
Article in Chinese | EMBASE | ID: covidwho-20238692

ABSTRACT

With the development of science and technology, electronic information technology has penetrated into many aspects of society now. Electronic informed consent is an effective way to adapt to development clinical trial. China is still at an early stage in this field. Affected by the outbreak of COVID-19 in 2020, the demand for electronic informed consent in clinical trial has become more urgent. Based on my own work experience, the author wants to analyze the problems in the traditional informed consent process and the current situations of electronic informed consent in China and explores the feasibility of electronic informed consent in clinical trials.Copyright © 2021 Drug Evaluation Research. All rights reserved.

19.
The American Journal of Managed Care ; 2023.
Article in English | ProQuest Central | ID: covidwho-20237797

ABSTRACT

In this commentary, we report on lessons learned over 2 years (2020-2022) from conducting primary care research through a novel alliance of an ACO consisting of independent practices, a health plan, and several academic researchers, with the support of a private foundation. Am J Manag Care. 2023;29(6):In Press _____ Takeaway Points The process of collaborating on research was mutually beneficial for a network of independent practices and a group of academic researchers. * The process benefited the practices by facilitating more precise thinking about quality improvement, motivating the staff, and enabling readiness for health system change. * The process benefited the researchers by illuminating nuances of clinical and organizational workflow and revealing the practices' in-depth understanding of the communities they serve. * If practices have more federally funded opportunities to consistently participate in research, it could help speed greater adoption of payment reform models to promote health equity at the state and national levels. _____ A 2021 National Academies of Sciences, Engineering, and Medicine report, Implementing High-Quality Primary Care, has called out the persistent "neglect of basic primary care research" in the United States.1 A 2020 study by the RAND Corporation found that primary care research represents only 1% of all federally funded projects (including projects funded by the National Institutes of Health, the Agency for Healthcare Research and Quality [AHRQ], and the Veterans Health Administration).2 However, innovation in primary care is central to advancing health care delivery. Leaders in health care innovation recently called for CMS to test a proposal for primary care payment reform in accountable care organizations (ACOs) composed of independent practices (ie, practices not owned by hospitals).3 By innovating in independent practices, these leaders argued that CMS would provide incentives for those practices to stay independent, thereby potentially decreasing the vertical market consolidation that contributes to rising health care costs.3 Yet these same practices may have less experience with the kind of systematic innovation that leads to generalizable insights, because what little funding is available for primary care research is mostly awarded to large academic medical centers.1 AHRQ's practice-based research networks have not fully addressed this gap, as they have struggled to find infrastructure and maintain funding.1 In this commentary, we report on the lessons we learned over 2 years (2020-2022) from conducting primary care research through a novel alliance of an ACO consisting of independent practices, a health plan, and several academic researchers, with the support of a private foundation. [...]ACPNY found that experience with research facilitates innovation and readiness for health system change (lesson 1C).

20.
Neuropsychiatrie de l'enfance & de l'Adolescence ; 71(4):167-177, 2023.
Article in English | Academic Search Complete | ID: covidwho-20237309

ABSTRACT

Le trouble de la personnalité borderline est un trouble psychiatrique fréquent qui apparaît à l'adolescence. La thérapie comportementale dialectique adaptée aux adolescents (TCD-A) a montré son efficacité dans la prise en charge psychothérapeutique des adolescents souffrant de conduites suicidaires ou d'auto-agressivité associées au trouble de la personnalité borderline. Au travers de notre étude nous avons souhaité explorer la faisabilité et l'acceptabilité, pour des adolescents présentant un TPL diagnostiqué ou des troubles de la régulation des émotions, d'un module TCD intitulé « tolérance à la détresse » proposé sur le mode d'un groupe multi-familles. Pour ce faire nous avons mis en place un groupe multi-familles de six adolescents et de leurs parents. L'acceptabilité et la faisabilité du protocole étaient excellentes. Les témoignages des adolescents et de leurs parents nous apportent des informations précieuses sur l'intérêt d'un tel groupe et sur les améliorations à introduire. La mise en place d'un tel groupe est une première en France et nous souhaitions montrer par notre étude pilote, sa faisabilité, son acceptabilité et ses effets afin de promouvoir son développement et son implémentation dans le contexte pédopsychiatrique français. Borderline personality disorder is a common psychiatric disorder emerging in adolescence. Dialectical Behavioral Therapy adapted to adolescents (DBT-A) has proven to be effective as a psychotherapeutic treatment for adolescents suffering from borderline-related behaviors, such as suicidal or self-aggressive behaviors. In our study, we were interested in exploring the feasibility and acceptability of a DBT-A module entitled "distress tolerance", which reduces borderline-related behaviors in borderline adolescents or undiagnosed adolescents who experience difficulties in regulating their emotions. To do this, we set up a pilot study with one multi-family treatment group of six adolescents and their parents. The treatment was fully accepted by all adolescents and parents with an excellent acceptability. Comments from adolescents and parents gave us valuable information about the great interest of a multi-family treatment group and potential improvements for its implementation. This is the first study exploring a DBT-A multi-family treatment group in France. It highlights its feasibility, acceptability and potential positive effects. Further studies are needed to promote the implementation and development of such interventions in the context of child and adolescent psychiatry in France. [ FROM AUTHOR] Copyright of Neuropsychiatrie de l'enfance & de l'Adolescence is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

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