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Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.
The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.
The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.
The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.
Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of
The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal
Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.
This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.
This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.
Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.
A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.
Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.
EudraCT 2022-003589-19.
This study aimed to develop a core outcome set (COS) for trials evaluating the effects of complementary therapies in people with multiple sclerosis (pwMS). We sought to identify the outcomes most relevant to pwMS, their relatives and friends, healthcare professionals and researchers and to propose these for inclusion in future trials.
A participatory international research project using a mixed-method approach with qualitative and quantitative methods. The study included a scoping review and a national survey in Switzerland to identify candidate outcomes, followed by an international COS survey to rate the importance of these outcomes. The final phases involved two consensus meetings to refine and finalise the COS.
Data were sourced from the published literature and input from international stakeholders.
pwMS and other relevant stakeholders, including their relatives and friends, healthcare professionals and researchers.
A total of 770 individuals participated in the international COS survey of 39 candidate outcomes (662 pwMS, 27 relatives/friends, 58 healthcare professionals and 23 researchers). According to the survey results, 13 outcomes were added to the COS, 5 were excluded and 21 were classified as ‘no consensus’. 13 individuals (six pwMS, one pwMS’s friend, three healthcare professionals and three researchers) attended the first consensus meeting. Following the voting on the outcomes without consensus, seven outcomes were added to the COS, four were excluded and 10 outcomes were still classified as ‘no consensus’. The six members of the stakeholders advisory board (one pwMS, four healthcare professionals and two researchers) attended the second consensus meeting to define the final COS. Nine additional outcomes were included in the COS. Sexual problems, an outcome previously excluded, were also added. In total, 30 outcomes were included in the final COS.
We have developed the first COS for future trials of complementary therapies for pwMS. The use of this COS will promote that future research in complementary therapies is relevant for pwMS and other stakeholders involved in MS care. Future COS research should integrate diverse geographical regions, where perspectives and access to complementary therapies may vary.
Emerging adulthood is a new life stage characterised by identity exploration, instability, self-focus, a feeling of ‘being in-between’ and the perception of a range of possibilities. Emerging adults may experience difficulties in their well-being during this complex stage. Adaptive emotion regulation can improve levels of well-being. Previous studies have shown that new technologies can enhance social-emotional competencies in this population. The purpose of the study is to design and implement a serious game, emoWELL, which improves knowledge and the use of adaptive skills of emotion regulation to improve well-being during emerging adulthood.
The participants will be 385 emerging adults aged 18–29 years. They will be randomly assigned to either the control or experimental group. The experimental group will complete the emoWELL serious game. The game takes place on a train ride with several stops where the player will learn about emotion regulation. To assess the effectiveness of emoWELL, psychological assessment instruments validated in the Spanish population will be used. The primary expected outcomes include characteristics of emerging adulthood, emotion regulation (emotion dysregulation, emotion regulation strategies and cognitive reappraisal and expressive suppression) and psychological well-being. The secondary expected outcomes are self-esteem, psychological distress, loneliness and optimism. The assessment will occur at two different time points: pretest (T1) and post-test (T2) to observe improvements in the variables of interest.
The study has been approved by the Ethics Committee of the Universitat de València (2013883) and will follow the standards of the Declaration of Helsinki for data collection. The findings will be shared with the scientific community. The intellectual property registration number is as follows: UV-SW-202460R.
Preventing online and offline sexual harassment (SH) is a public health priority, due to its worldwide magnitude and short- and long-term consequences to the victims and survivors. Universities are environments that may facilitate different forms of conflicts, including SH, but they also play a key role in preventing and addressing them. This paper describes ‘Uni4Equity’, a European project funded by the CERV-2022-DAPHNE Programme of the European Union (Ref. 101094121-Uni4Equity) aimed to reinforce universities’ readiness to identify, map and respond to online and offline SH at workplace and other relevant settings (classrooms, digital space), with an explicit (but not exclusive) focus on minority social groups. More specifically, the project will address the research needs of conducting multidimensional diagnosis of SH at universities (scale and determinants) as a basis for preventive actions; assessing the effectiveness of preventive interventions such as social media campaigns and training workshops; creating a university culture that actively rejects SH; improving access to existing support services; and contributing to the acknowledgement of universities as an asset in preventing this issue.
The project follows an exploratory sequential design for the period 2023–2026. In phase 1, a mixed-method initial assessment based on online surveys, semistructured interviews and desk reviews is planned in six targeted universities: University of Alicante, Adam Mickiewicz University (AMU), University of Maia, University of Applied Sciences Burgenland (UASB), University of Antwerp (UAntwerp), University of Verona. Phase 2 integrates long-term and large-scale interventions at different levels of prevention (primary, secondary and tertiary) and implementation (interpersonal, institutional and social). These interventions combine online and offline training programmes addressed to students and staff, arrangements with internal and external support services and improvements in access to information and resources, including SH protocols and regulations. Phase 3 consists of qualitative and quantitative evaluations of the different Uni4Equity interventions and a final evaluation of the global impact of the project.
Ethical approval was obtained by the different universities research ethics committees (Universidad de Alicante, vice-rectorate for research: Ref. no. UA-2023-03-27; Università di Verona, Comitato di Approvazione per la Ricerca sulla Persona: Ref. no. UNIVR-24/2023; UAntwerp, Ethics Committee for the Social Sciences and Humanities: Ref. no. EX_SHW_2023_38_1; AMU, Ethics Committee for Research Involving Human Participants, Ref. no. UAM_19/2022/2023; UASB, Ethics Committee: Ref. no. UASB _28/08/2023; Universidade da Maia, Conselho de Ética e Deontologia: Ref. no. UMAIA_ 151/2023).
The research team will disseminate findings through peer-reviewed journal articles, presentations in scientific national and international events, policy briefs, infographics, videos and short reports.
FreshRSS 