Strengthening universities response to sexual harassment with an equity approach: the UNI4EQUITY mixed-methods study protocol

Introduction
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.

Methods and analyses
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.

Ethics and dissemination
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.

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[Articles] Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study

In this phase II trial of postmenopausal women with osteoporosis, narlumosbart demonstrated superiority over placebo in increasing BMD at 12 months following administration at 6-month intervals, with a tolerable safety profile in the short term, consistent with that of anti-RANKL monoclonal antibodies.

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[Articles] Effectiveness and safety of strategies to optimise antimicrobial use in solid organ transplant recipients. Systematic review and meta-analyses

Strategies to optimise antimicrobial use are safe, with no negative impact on mortality or transplant-related complications, and appear to improve some clinical outcomes in SOTr, particularly when using perioperative antimicrobial prophylaxis in kidney SOTr and when implementing AMS programmes. No difference in the rate of surgical site infection was found between short and extended duration of antimicrobial prophylaxis for kidney and liver SOTr. This suggests that a shorter duration of antimicrobial surgical prophylaxis may be safe for transplant recipients.

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Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial

Introduction
Pain is one of the most bothersome symptoms that affects patients with inflammatory bowel disease (IBD) but is often inadequately treated. Inadequate pain control in the inpatient setting not only impacts patients’ experience but increases opioid use and hospital length of stay. Opioids are often considered first-line treatment for severe pain but are associated with significant morbidity and mortality in IBD. Non-steroidal anti-inflammatory drugs are a non-opioid analgesic option, but concerns regarding their contribution to IBD flares have limited their use. Brain-gut behavioural therapies (BGBT), such as cognitive behavioural therapy, meditation and gut-directed hypnotherapy, are effective for pain management and have a role in the treatment of IBD symptoms. However, the use of BGBT in IBD is challenging, given limited access to behavioural health specialists, especially in the inpatient setting. Virtual reality (VR)-directed BGBT programmes can bridge this gap and enhance pain treatment for inpatients with IBD. Therefore, in this study, we aim to establish feasibility and acceptability for a VR-directed BGBT inpatient programme for patients with IBD.

Methods and analysis
We will recruit 40 patients with IBD who are hospitalised at Michigan Medicine and who endorse IBD-related pain. We will assess patient-reported outcomes (pain rating, IBD-specific symptoms, perceived stress, mood) before and after treatment, cumulative inpatient analgesic requirements and hospital length of stay. Our primary objective will be to establish intervention feasibility defined by the frequency and percentage of enrolled participants that use the VR-directed BGBT inpatient intervention in any capacity. Our secondary objective will be to evaluate intervention acceptability by conducting semistructured interviews with study participants. We will also explore the preliminary effectiveness of VR-directed BGBT on patient-reported outcomes and healthcare utilisation as compared with historic controls.

Ethics and dissemination
The study was approved by the institutional review board of the University of Michigan Medical School on 10 October 2023 (HUM00240999). All human subjects will be required to sign an informed consent document prior to study participation. Study findings will be reported through peer-reviewed publication.

Trial registration number
NCT06188793.

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AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers – comparing facial versus intranasal administration via pharmacometric modelling

Introduction
Pain accounts for approximately 80% of emergency department admissions. While intravenous morphine titration is commonly used for severe pain, non-invasive alternatives that bypass intravenous access are needed. Nebulised fentanyl, combined with pupillometry for objective monitoring of opioid impregnation, may offer a rapid and safe alternative for pain management.

Methods and analysis
This phase I, open-label, randomised, exploratory, crossover, single-centre prospective controlled trial will employ pharmacokinetic–pharmacodynamic (PK–PD) modelling to assess the variability in bioavailability of nebulised fentanyl administered via intranasal route versus facial aerosol. 20 healthy volunteers will receive three repeated administrations of fentanyl over two visits. At each visit, blood samples (n=11) will be collected for fentanyl quantification by liquid chromatography–tandem mass spectrometry, and pupillary unrest in ambient light (PUAL) measurements (n=9) will be recorded. The resulting data will be analysed using Monolix 2024R1 to model PK–PD relationships, perform Monte Carlo simulations and determine the optimal dosing and timing required to achieve a reduction of more than 30% in PUAL, while also evaluating safety, comfort and tolerance.

Ethics and dissemination
The study has been approved by the Ethic Committee Île-de-France VII (approval reference number: 000216, February 2024) and will be conducted in accordance with the Declaration of Helsinki. Informed consent will be obtained from all participants. Study findings will be disseminated through peer-reviewed publications, conference presentations and appropriate data-sharing platforms to support further research and clinical application.

Trial registration number
This trial is registered at ClinicalTrials.gov (Identifier: NCT06281951).

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Improving Delirium Identification in Hospitalized Older Adults

Delirium affects one-third of hospitalized older adults and is associated with prolonged length of stay, institutional discharge, long-term functional and cognitive decline, Alzheimer disease and related dementias (AD/ADRD), and death. Moreover, the costs of delirium exceed $182 billion annually in the US alone. Despite these compelling data, accurate identification of delirium remains challenging, with more than half of delirium going unrecognized in routine care. While delirium prevention has advanced substantially, delirium treatment, which relies on early and accurate identification, lags. More than 40 tools are available for delirium assessment, ranging from short structured screens to in-depth reference standards. Evidence on how to implement these tools to improve delirium identification at the bedside, including which tool to use, who should administer it, how often, and how to educate and engage the care team, remains limited.

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Blood-Based Colorectal Cancer Screening

Despite a significant decline in colorectal cancer (CRC) incidence and mortality over the past several decades in the US, CRC remains the second leading cause of cancer deaths. Most of these deaths could be prevented if the 42% of Americans aged 45 to 75 years who are not up to date with screening would participate. There is strong evidence supporting screening with lower intestinal endoscopy (ie, colonoscopy or flexible sigmoidoscopy) or repeated rounds of occult blood–based stool screening tests. These screening tests are effective in detecting cancer at early, curable stages as well as preventing cancer through detection and removal of advanced precancerous lesions, including adenomas and serrated colorectal lesions. Despite public awareness campaigns, organized screening (eg, programmatic mailed stool-based tests), and patient decision aids and navigation, participation is suboptimal, and closing the screening gap remains elusive. This gap may result from reluctance to complete screening due to inconvenience, discomfort, embarrassment, aversion to handling stool, or fear of complications. The ideal CRC screening test would be noninvasive and acceptable to those being screened, be highly sensitive for both early cancer and advanced precancerous lesions, have excellent specificity, and be widely accessible. All of the currently available CRC screening test options fall short of this ideal in at least 1 way, limiting their effectiveness. Thus, there is an ongoing search for more agreeable screening test options.

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Group Omitted From Article Byline

In the Original Investigation titled “Optimizing Pemphigus Management With Rituximab and Short-Term Relapse Predictors,” published online on February 5, 2025, and in the April 2025 issue, the author byline omitted the MALIBUL group. The article byline was corrected online.

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Illicit Opioid Use May Be More Prevalent Than Previously Estimated

A new study of US survey data published in JAMA Health Forum found that 11% of respondents reported having used nonprescription opioids between June 2023 and June 2024, including about 8% who reported using illicitly manufactured fentanyl. The online survey included a nationally representative sample of about 1500 US participants aged 18 years or older.

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Optimal Data Sources for Studies of Incident Dementia

In JAMA Internal Medicine, Luchsinger et al describe the results of a prespecified secondary analysis of the GRADE clinical trial on cognitive performance. The GRADE trial randomized 3721 patients with type 2 diabetes using metformin at baseline to add either a long-acting insulin, a sulfonylurea, a glucagon-like peptide-1 (GLP-1) agonist, or a dipeptidyl peptidase-4 inhibitor. At 4 years following randomization, cognitive performance was not different between treatment groups across 3 validated cognitive tests. However, worsened glycemic control was associated with modestly lower cognitive test scores. These findings provide important data for clinicians, particularly in light of recent lay press and scientific enthusiasm about GLP-1 agonists for dementia prevention.

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Assessing symptom improvement in patients with postural orthostatic tachycardia syndrome (POTS) following a 16-week structured exercise programme: a protocol for a randomised cross-over trial in a clinical outpatient setting

Introduction
Exercise training is recommended as a complementary treatment in postural orthostatic tachycardia syndrome (POTS) according to international guidelines. However, less is known regarding how exercise training could successfully be implemented in clinical practice in patients with POTS. Thus, in the current study, we aim to assess the effect of a 16-week tailored exercise training programme in POTS.

Methods and analysis
A total of 200 patients diagnosed with POTS will be recruited. The study will be conducted as a randomised cross-over study. POTS symptoms will be evaluated using the Malmö POTS Symptom Score, Orthostatic Hypotension Questionnaire and 36-item Short Form Health Survey. Haemodynamic parameters will be evaluated by orthostatic tests and maximum working capacity evaluated by bicycle exercise test. Symptoms, haemodynamic parameters and exercise capacity will be assessed before and after a 16-week training programme.

Ethics and dissemination
The study was approved by the Swedish ethical review authority (2022-03186-01) and all procedures will be performed in accordance with the Helsinki Declaration. Results will be made available to patients with POTS, healthcare professionals, the funders and other researchers in publicly available (open access) medical journals.

Trial registration details
NCT05554107, registered on 26 September 2022.

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Family profiles in relation to early childhood caries: a cross-sectional study in France

Objective
There are no clearly defined family profiles with an overall view of the predictors of early childhood caries (ECCs). The aim of our study was to identify the profiles of families that are particularly affected by ECCs. We also examined the factors that can be acted on to promote oral health.

Design
In this single-centre cross-sectional study, the researchers examined the mouths of 300 children with caries and recorded the Decayed, Missing and Filled Teeth Index (dmft). These observations were supplemented by a questionnaire completed by the families, focusing in particular on their sociodemographic characteristics (e.g. age, parents’ professions and jobs, social assistance and family composition).

Setting
This work was conducted at Lille University Hospital between 2019 and 2024.

Participants
The participants included 300 caregiver-child dyads with children under the age of 6 years.

Primary and secondary outcome measures
Childhood Caries Index (dmft) and family characteristics associated with ECCs.

Statistical analyses
A multiple correspondence analysis was used, followed by a hierarchical clustering on principal components analysis, to identify the family profiles associated with ECC risk.

Result
Of the patients included in the study, 42% were girls, 58% were boys and their mean age was 4 years (±1.1 years). The mean dfmt index was 8.7 (±4.6); 77% of the participants had lesions on the smooth surfaces of the teeth, and 80% of the participants had a severe stage of caries disease. The analysis revealed three high-risk profiles based on the characteristics of the child’s mother and the family sibling composition. The first profile was larger families where the focal child was not the eldest. The second profile was families with foreign-born mothers and a low socioeconomic level. The third profile was families with mothers facing geographical and financial difficulties in accessing healthcare.

Conclusion
This study enabled us to identify the profiles of families at risk of caries. These at-risk profiles highlight the need to implement specific interventions acting at different levels and focused on oral health education in interprofessional practice during the key period of the first 1000 days of life. These factors could help to bridge the gap between oral health and general health, improve children’s oral health and reduce social health inequalities.

Ethics and dissemination
This human study has been ethically approved by the French Committee for the Protection of Individuals (N° 2019-A00827-50).

Trial registration number
The protocol is recorded on clinicaltrials.gov, with ID: NCT04195607.

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