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A multicenter, randomized, parallel-group confirmatory study protocol to evaluate the efficacy of Soft Protector CPC, a novel oral mucosal protectant, in preventing oral mucositis and alleviating pain in patients with breast cancer

by Kazuhiro Omori, Kohei Furukawa, Masatoshi Usubuchi, Tomofumi Hamada, Tadahiko Shien, Michihiro Yoshida, Yuki Nakatsuka, Katsuyuki Hotta, Soichiro Ibaragi, Shogo Takashiba

Oral mucositis is a frequent and debilitating adverse event observed in patients undergoing chemotherapy or radiotherapy. Current management strategies are limited in duration, require frequent application, and fail to address the mechanical irritation from teeth. A novel device, Soft Protector CPC, was developed to overcome these limitations. This multicenter, randomized, two-arm, open-label, confirmatory trial aims to evaluate the efficacy and safety of Soft Protector CPC in patients with breast cancer undergoing chemotherapy. A total of 154 participants will be randomly assigned in a 1:1 ratio to receive either oral care with Soft Protector CPC or oral care alone. The primary endpoint will be oral mucositis as assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 during the comparative treatment period. The secondary endpoints will include CTCAE v3.0 during the continuous treatment period, oral mucositis, pain (CTCAE v5.0), quality of life (Patient Reported Outcomes-CTCAE version 1.0 [PRO-CTCAE v1.0], the 15-item oral health questionnaire of the European Organization For Research And Treatment Of Cancer [EORTC QLQ-OH15], and the pain Numeric Rating Scale), onset and site of mucositis, completion of chemotherapy, use of rescue medications, technical feasibility, and patient preference. The safety endpoints will include adverse events, device malfunction, and laboratory tests. This trial is expected to establish the clinical utility of the Soft Protector CPC for the prevention and management of oral mucositis, with the potential to improve the patients’ quality of life and adherence to cancer therapy. This study was approved by the Clinical Research Review Board and registered with the Japan Registry of Clinical Trials, jRCTs062250005, on April 18, 2025.

Comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT): study protocol for a randomised, controlled clinical trial

Por: Carey · D. L. · Ahlenstiel · G. · Brilot · F. · Brown · D. A. · Bull · R. · Crowther · H. · Cunningham · A. · Davenport · M. P. · Diamond · P. · Hamad · N. · Johnston · A. · Kelleher · A. D. · Lee · F. J. · Matthews · G. V. · Petoumenos · K. · Quichua · G. C. · Swaminathan · S. · Trotman
Introduction

Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

Methods and analysis

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

Ethics and dissemination

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

Trial registration number

NCT05415267.

Mass casualty incident preparedness and response: A desk review of the Code Orange Plan and Assessment of Healthcare Workers’ Knowledge, Attitudes, and Practices in a Lebanese Tertiary Government Hospital

by Linda Abou-Abbas, Rima Kashash, Mustapha Khalife, Mohamad Shafic Ramadan

Background

Effective preparedness and response to mass casualty incidents (MCI) are essential for hospital safety, operational efficiency, and the delivery of timely, high-quality patient care during emergencies. This study assessed a tertiary government hospital in Lebanon’s Code Orange plan by reviewing documentation for alignment with international guidelines and evaluating staff knowledge, attitudes, and practices (KAP) regarding MCI preparedness.

Methods

Documents reviewed at Rafik Hariri University Hospital (RHUH) included the current Code Orange plan, relevant policies, and international guidelines. A comprehensive evaluation framework was used, focusing on preparedness, incident command systems, communication, and management. A comparison with established standards was conducted to identify gaps. Complementing this, a cross-sectional study was conducted using a convenient sample of medical and non-medical healthcare workers to evaluate their KAP regarding MCI preparedness.

Results

The desk review of the RHUH Code Orange plan identified both strengths and significant gaps in MCI preparedness. While the plan defines staff roles and resources for emergency response, it lacks detailed procedures for activation strategies, surge capacity, continuity of essential services, and triage processes. Additionally, post-event recovery protocols are insufficient or absent, and the importance of regular drills is not adequately emphasized. The KAP study revealed significant differences between medical and non-medical staff in terms of MCI knowledge, involvement, and training engagement, with medical staff reporting higher levels of familiarity and desire for participation.

Conclusion

The findings underscore the need to bridge knowledge and engagement gaps between medical and non-medical staff to enhance MCI response. Key actions include interdisciplinary training to build coordination, clear communication protocols to streamline information flow, and routine drills with defined roles to strengthen preparedness. Additionally, implementing performance monitoring during drills and real MCIs, along with conducting regular evaluations, will allow for continuous refinement of response strategies.

Exploring the Perceived Effectiveness, Impact and Benefits of a Work‐Based Cancer Survivorship Peer Support Programme: A Qualitative Descriptive Study

ABSTRACT

Aim

To explore the perceived effectiveness, impact and benefits of a work-based cancer survivorship peer support programme for healthcare employees who have experienced or are experiencing cancer.

Design

A qualitative descriptive study.

Methods

Purposive sampling was used to recruit 33 participants (10 peers, 12 peer supporters, 4 line managers and 7 members of the governance group). Data were collected between October 2024 and February 2025 through individual interviews and focus groups. Data were analysed using reflexive thematic analysis.

Results

Four themes were generated: Programme Reach and Adoption, Implementing the Programme, Programme Effectiveness and Impact and Programme Maintenance and Growth. Challenges included the pilot status of the programme impacting awareness and uptake, potential reluctance to share diagnoses and the impact of cancer on colleagues. The approach of peer supporters was considered central to the programmes' success. Peer supporters valued training and continuous practice development opportunities.

Conclusion

Demonstrated benefits, including satisfaction and the value of peer support, were evident. To ensure programme maintenance, increased recruitment and training of peer supporters and clear communication regarding the programme and referral pathways are essential. Financial support is required to maintain training and address dissemination challenges.

Implications for the Profession

Work-based peer support programmes can help cancer survivors reintegrate into the workforce more effectively, rebuilding confidence, fostering resilience and navigating workplace expectations. Enhanced staff well-being may also positively influence retention, performance and health-related disruptions.

Impact

Findings from this underexplored area of work-based peer support within a healthcare setting have the potential to influence healthcare leaders, policy makers and future research. Improving staff's' quality of life on return to work benefits the individual, the organisation and care delivery by ensuring a healthy, supported workforce.

Reporting Method

The Standards for Reporting Qualitative Research (SRQR) checklist and the Template for Intervention Description and Replication (TiDieR) checklist were utilised.

Patient or Public Contributions

No patient or public contribution.

Assessment of safety culture in adults and paediatric critical care units in governmental hospitals in Kuwait: a cross-sectional study

Por: Alsaleh · F. · AlHamad · B. · AlSuwaidan · S. · Naser · A. Y.
Objectives

To describe healthcare professionals’ (HCPs) assessment of safety culture in adults and paediatric critical care units in governmental hospitals in Kuwait.

Design

A cross-sectional survey study.

Setting

Adults and paediatric critical care units in Kuwait from January to April 2023.

Participants

Full-time HCPs (physicians, nurses and clinical pharmacists) who are in direct contact with patients and work in adults and paediatric critical care units.

Primary outcome measure

Patient safety culture practices.

Results

The population consisted of 945 HCPs from adult and paediatric critical care units. In general, across most dimensions, perceptions were more positive toward the patient safety culture. Adult critical care settings were mostly higher in negative responses compared with the paediatric setting. In general, all the HCPs responded positively towards ‘Teamwork Climate’, ranging from 41.5% to 85.0%, with the same pattern in the adult and paediatric settings. In both settings, ‘Safety Climate’ in general was responded to positively, ranging from 51.3% to 86.2%, and patterns between the two settings were the same. ‘Job Satisfaction’ showed positive responses between 68.2% and 88.3%.

Conclusions

In this study, HCPs from adult and paediatric critical care units rated patient safety culture dimensions positively. The patient safety procedures needing improvement were staff shortages, harsh workloads, poor communication and training. Providing frequent communication training and supporting personnel could further strengthen the critical care safety culture.

Ageing phenotypes and behavioural determinants of health on age acceleration: the Cancer Survivors Trajectories of Ageing Research (C*STAR) study protocol

Por: Zaujan · N. A. M. · Shahril · M. R. · Shahar · S. · Mohamad Hanif · E. A. · Ab Muin · N. F. · Sharif · R. · Subramaniam · P. · Abdullah · A. · Fenech · M.
Introduction

Age acceleration in survivors of breast cancer is a critical issue because cancer and its treatment can increase structural and numerical chromosomal aberrations, while simultaneously shortening telomere length and changing ageing phenotype. Therefore, the current study will be using machine learning architectures to accurately predict the factors that contribute to age acceleration among survivors of breast cancer.

Methods and analysis

The Cancer Survivors’ Trajectories of Ageing Research (C*STAR) is a hospital-based cross-sectional study involving multi-ethnic Malaysian survivors of breast cancer and a non-breast cancer control group, frequency-matched by age group (±5 years), sex and ethnicity. The three main stages of this study will be conducted in the predictive model development. First, a set of validated questionnaires will be used to collect the data on modifiable factors of ageing phenotypes and behavioural determinants of health. Second, 3 mL non-fasting blood samples will be collected, and lymphocytes will be isolated to determine telomere length using real-time PCR as a biomarker of age acceleration. Lastly, a machine learning architecture will be deployed to identify modifiable factors that may contribute to age acceleration in survivors of breast cancer and controls, with these factors used as input and ageing biomarkers of telomere length as output. The study outcomes may serve as guidance to enhance the quality of life of survivors of breast cancer and hinder the recurrence of cancer while ageing successfully.

Ethics and dissemination

Ethical approval was obtained from the Research Ethics Committee, Universiti Kebangsaan Malaysia (JEP-2022-700) to carry out this study. Written informed consent will be obtained from each survivor of breast cancer and each cancer-free woman prior to participation. The results of this study will be published for future research and clinical applications.

Bridging the stroke care gap: development and validation of CaknaStrok Education Package (CEP) for caregivers of stroke survivors in Malaysia

Por: Sidek · N. N. · Kamalakannan · S. · Musa · K. I. · Long Tuan Kechik · T. S. M. · Hamzah · N. · Abd Hamid · R. I. · Darus · D. · Ibrahim · K. A. · Seman · N. · Ahamad Fouzi · L. · Abdul Hamid · F. · Ismail · T. A. T.
Background

Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

Objectives

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Design

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Setting

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Participants

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

Methods

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

Results

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

Conclusions

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

Efficacy of Digital Mental Health Interventions for Depression and Anxiety in Older Adults: A Systematic Review and Meta‐Analysis

ABSTRACT

Background

Older adults face growing risks of depression and anxiety, yet stigma, comorbidities, cost, and limited access impede receipt of conventional care. Digital mental health interventions (DMHIs), including immersive virtual reality (VR), exergaming, and mobile apps, may reduce these barriers.

Aim

To evaluate the efficacy of DMHIs in reducing depressive and anxiety symptoms among adults aged ≥ 50 years.

Methods

We conducted a PRISMA adherent systematic review and meta-analysis of randomized controlled trials. Interventions included immersive VR, exergaming/physical digital platforms, mobile applications, and digital cognitive training. Standardized mean differences (SMDs) were pooled with random effects models; heterogeneity was assessed with I 2.

Results

Nineteen RCTs (n = 718; mean ages 50.9–84.7 years) met inclusion criteria. Across studies, DMHIs significantly reduced depressive symptoms (SMD = −0.656, 95% CI = −0.932 to −0.380; p < 0.001) and anxiety symptoms (SMD = −0.559, 95% CI = −0.740 to −0.380; p < 0.0001). Immersive and physically engaging modalities (e.g., VR, exergaming) outperformed app-based approaches. Heterogeneity ranged from moderate to high (I 2 ≈ 69.6%–97%).

Linking Evidence to Action

Offer DMHIs: especially VR or exergaming when access to in-person therapy is limited or as an adjunct to usual care. Provide brief onboarding and, when feasible, caregiver support to boost adherence and confidence with technology. Select or configure age-friendly interfaces (e.g., large fonts, simple navigation) to address common usability barriers. Integrate DMHIs into stepped-care or rehabilitation pathways and monitor outcomes with validated tools (e.g., GDS, STAI). Address equity by supplying devices/connectivity solutions and consider cost-effectiveness and long-term engagement in implementation plans.

Trial Registration: PROSPERO ID: CRD420250655153

Family functionality and its association with non-communicable diseases among urban adults in Selangor, Malaysia: a cross-sectional study

Por: Abdullah · N. N. · Mohammed Ali Azzani · M. · Mohamad · M. · Ismail · Z. · Jamil · A. T. · Isa · M. R. · Yasin · S. M. · Suddin · L. S. · Ibrahim · K. · Selamat · M. I. · Azhar · Z. I. · Ismail · N. · Ahmad Saman · M. S. · Xin Wee · C. · Samsudin · E. Z. · Muzaini · K. · Yaacob · S. S.
Objectives

Non-communicable diseases (NCDs) are rapidly escalating in developing countries and social factors such as the dynamics of the family play an important part in the lifestyle choices that lead to the onset and maintenance of chronic illness. There remains a gap in Malaysia as the majority of the studies were focused on the normal population rather than directly towards persons having NCDs. This study aimed to examine emerging risk factors such as family functionality and its association with NCD.

Design

A cross-sectional survey was conducted using a multistage random sampling method.

Setting

Urban residential areas in Selangor, Malaysia.

Participants

A total of 2542 adults residing in urban areas of Selangor were recruited.

Primary and secondary outcome measures

Family functionality was measured using the APGAR (Adaptation, Participation, Gain or Growth, Affection and Resources) scale and multiple logistic regression was performed to measure the association between emerging risk factors and NCD.

Results

The prevalence of diabetes mellitus and hypertension was 10.8% and 6.1%, respectively. Widowed/separated status (adjusted OR (AOR) 41.53, 95% CI 19.06 to 90.48, p value=0.001) was reported to be a predictor of diabetes. As for hypertension, familial functionality (AOR 4.2, 95% CI 1.11 to 14.50, p value

Conclusions

There is a growing concern that family functionality is an emerging risk factor for NCDs. Future family-centred health promotion programmes should be incorporated to improve self-management behaviours and health outcomes.

Community pharmacists’ history taking practice in responding to acute uncomplicated cystitis: A simulated patient study from Sudan

by Riham M. Hamadouk, Esra D. Albashair, Einass M. Alshareif, Ali Awadallah Saeed, Bashir A. Yousef

Background

Today, community pharmacists’ responsibilities have expanded beyond the traditional role to include the management of minor ailments. Acute uncomplicated cystitis is one of the most prevalent medical conditions seen in primary healthcare and can be managed by community pharmacists (CPs).

Objectives

To evaluate community pharmacists’ history-taking practice when responding to patients with acute uncomplicated cystitis.

Methods

A cross-sectional simulated patient study was conducted from November 2022 to January 2023 in Khartoum locality targeting only pharmacists. Six trained female students played the simulation in which they pretended to have the clinical symptoms of acute uncomplicated cystitis and requested treatment for their condition. The Interactions during the simulation were documented immediately in a data collection form after each visit. Descriptive statistics were used to report the study outcomes.

Results

A total of 238 community pharmacies were visited. The majority of the pharmacists were female. The mean of the number of questions that were asked by the pharmacists was 1 (SD = 1.6) questions. Among the studied pharmacists, 45.4% asked at least one question during patient assessment. The most asked question was if the patient has a fever, representing 61 (25.6%) CPs, followed by if there is vaginal discharge, representing 38 (16%) CPs. In response to scenario 47 (19.7%) CPs decided to refer the patient to a physician, and 45 (18.9%) of the CPs advised the patient to increase water intake.

Conclusions

The study has revealed a poor history-taking practice towards acute uncomplicated cystitis during patient assessment. Further studies exploring pharmacists’ involvement in patient assessment are required. Strategies to improve community pharmacists’ practice, like continuing pharmacy education and providing a national guideline regarding patient assessment should be considered seriously.

Nutritional knowledge, attitudes and practices and their determinants among pregnant women attending healthcare centres in southern Tehran

Por: Rajaeieh · G. · Bakhtiari · A. · Gholami · M. · Ghavidel · F. · Mostafavi · H. · Zabihi · M. · Mohamadi · E. · Olyaeemanesh · A. · Takian · A.
Objectives

To assess nutrition-related knowledge, attitudes and practices among pregnant women, and identify socioeconomic and healthcare determinants.

Design

A cross-sectional study on maternal nutrition during pregnancy.

Setting

Pregnant women attending primary healthcare centres in the south of Tehran from December 2022 to March 2024.

Participants

1535 pregnant women of all ages living in the south of Tehran (both Iranian and non-Iranian).

Measures

Pregnant women were systematically selected from primary healthcare centres. Data were collected via validated questionnaires and electronic health records. Statistical analyses included multivariate logistic regression (adjusted ORs (aORs) with 95% CIs) and generalised linear mixed models.

Results

The findings revealed that a majority of pregnant women (83.3%; 95% CI 81.2% to 85.3%) exhibited low levels of nutritional knowledge (scores below 12), whereas 14% demonstrated moderate knowledge (scores between 12 and 17), and only 2.7% (95% CI 1.9% to 3.8%) possessed high nutritional knowledge (scores above 18). In terms of attitudes, 36.9% of respondents expressed positive views toward nutrition, with higher education significantly associated with positive attitudes (aOR=1.8; 95% CI 1.3 to 2.5, comparing higher vs lower education levels). Dietary variety was consistently reported by 65.4% of participants, while 8.5% lacked dietary variety. Statistically significant associations were observed between educational attainment, socioeconomic status and nutrition-related practices (p

Conclusion

As a cross-sectional study, these findings highlight substantial gaps in nutrition knowledge among pregnant women in Tehran, with socioeconomic status and education playing crucial roles in shaping dietary behaviours. Improving nutritional education through healthcare interventions is essential for enhancing maternal and fetal health outcomes.

Association between depression, anxiety and loneliness with internet addictions among public university students in Malaysia

Por: Muhamad · N. A. · Maamor · N. H. · Tengku Baharudin Shah · T. P. N. · Jamalluddin · N. H. · Leman · F. N. · Rosli · I. A. · Nik Azhan · N. A. F. · Chemi · N. · Muhamad Rasat · M. A. · Abdullah · N. · Abdul Jabbar · N. · Ibrahim · N. · Mohamad Isa · M. F.
Objective

To determine the prevalence of internet addiction and examine its association with psychological factors specifically depression, anxiety and loneliness among Malaysian public university students.

Design

Cross-sectional study.

Setting

All public universities in Malaysia, 20 universities.

Participants

The study included 7278 students from 20 public universities in Malaysia.

Main outcome measures

Statistical analyses were performed usingSTATA V.17 software. Descriptive statistics summarised participants’ demographic characteristics, prevalence of internet addiction and psychological distress (depression, anxiety and loneliness). Pearson’s correlation was used to assess bivariate relationships between internet addiction and psychological variables, while multiple logistic regression identified independent factors associated with internet addiction after adjusting for significant confounders.

Results

The study found that 38.6% of the students showed signs of internet addiction, along with a high level of psychological distress; 24.8% had depressive symptoms, 32.4% experienced anxiety and 35.5% reported loneliness. Moderate positive correlations were observed between internet addiction and depression, anxiety and loneliness (p

Conclusion

The findings indicate significant associations between internet addiction and psychological factors such as depression, anxiety and loneliness. A comprehensive, multifaceted approach is essential to address psychological distress among university students and reduce the risk of internet addiction.

Epidemiology and disease burden of connective tissue disease-associated interstitial lung disease (CTD-ILD) in Asia: a systematic review and meta-analysis protocol

Por: Chua · F. · Subramaniam · S. · Lai · W. H. · Tan · S. H. · Yean · H. R. A. · Kho · S. S. · Yew · J. S. Y. · Hong · H. C. · Ng · C. C. M. · Sirol Aflah · S. S. · Mohd Zaidi · N. A. · Ong · V. H. · Chai · G. T. · Ang · S. H. · Maamor · H. · Muhamad · N. A.
Introduction

Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.

Methods and analysis

This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.

PROSPERO registration number

The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).

Barriers and challenges for preventing inpatients falls in tertiary healthcare facilities following the COVID-19 pandemic: a scoping review protocol

Por: Mohd Noor · J. · Jamil · M. F. A. · Abdul Hamid · N. · Chong · E. G. M. · Ling · J. N. · Subramaniam · S. · Lai · W. H. · Muhamad · N. A.
Introduction

Hospital patients are at an increased risk of falls, which are a significant safety concern within healthcare settings.1 Understanding how the COVID-19 pandemic has influenced fall risks is essential for identifying key factors that could inform future fall prevention strategies.2 This scoping review aims to explore the barriers and challenges associated with preventing inpatient falls in the context of the post-COVID-19 environment.

Methods and analysis

The methodology for this scoping review follows the framework established by Arksey and O’Malley. A comprehensive literature search will be conducted using specific keywords to identify relevant published studies. Searches will be performed across selected electronic databases, including PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science, covering publications from 2014 to 2024. This review will focus on a global perspective. Two authors will independently screen titles and abstracts to identify potential studies for inclusion. Studies meeting the inclusion criteria will be retrieved for full-text review, and their references will be assessed for relevance using the same criteria. The PRISMA flow diagram will guide the review process. Data will be extracted, analysed and charted according to categories from the selected publications.

Ethics and dissemination

This scoping review will provide a comprehensive overview of the barriers and challenges in preventing inpatient falls in the post-pandemic context. The findings will be disseminated through submission for publication in a scientific journal.

Registration details

This scoping review protocol is registered with Open Science Framework (OSF) available at https://osf.io/.

Is harmonisation of curriculum enough to ensure clinical competencies of graduates? Experience of faculty and students from two health training institutions in Tanzania: a qualitative study

Por: Sirili · N. · Temba · P. · Yoram · F. · Kitambala · E. · Hamad · A. K. · Sabas · D. · Mloka · D. · Moshi · M. J. · Mselle · L. T.
Objective

The growing complexity of global health issues underscores the need for a skilled workforce, achievable through competency-based training (competency-based curricula, CBC) that integrates knowledge and practice. Starting from 2022, medical and nursing CBC were harmonised across universities in Tanzania to ensure all graduates attain nationally defined core competencies. The reform aligned programme structure, learning outcomes and assessment methods to promote consistency and interprofessional collaboration. However, questions remain about whether harmonisation alone can ensure the development of practical clinical competencies among students. This study explored the experiences of medical and nursing faculty and students in implementing clinical training as a component of CBC in two health training institutions in Tanzania.

Design

An exploratory qualitative case study was conducted with 67 participants, using 8 in-depth interviews with administrators and 8 focus group discussions with faculty and students. Data were analysed using Braun and Clarke’s thematic approach.

Setting

Two private, faith-based medical universities in the United Republic of Tanzania.

Participants

The study purposefully recruited a total of 67 participants. The participants included university administrators (including Deputy Vice Chancellors for Academics, quality assurance officers and deans), medical and nursing faculty and students (fourth-year medical and third-year nursing students).

Results

Two main themes emerged: challenges in implementing clinical training and strategies used to enforce clinical training. Key challenges included curriculum design gaps, inadequate faculty and clinical instructors, a large number of students and a shortage of hospital staff. Strategies used were utilisation of clinical skills and simulation laboratories, involvement of non-academic clinical specialists’ staff, use of student-centred learning methodologies and leveraging regional, district and specialised private hospitals for clinical teaching.

Conclusions

Despite notable challenges in clinical training, the institutions in this study have implemented proactive strategies to support clinical training. Based on the findings, stakeholders should invest in increasing faculty and clinical instructors and expanding clinical placements to regional, district and private hospitals.

Barriers and challenges in preventing falls among community-dwelling patients with dementia: a scoping review protocol

Por: Jamil · M. F. A. · Mohd Noor · J. · Abdul Hamid · N. · Chong · E. G. M. · Ling · J. N. · Subramaniam · S. · Lai · W. H. · Muhamad · N. A.
Introduction

Falls are highly prevalent among individuals with dementia, largely due to the cognitive and physical impairments associated with the condition. Understanding the barriers and challenges to fall prevention in community-dwelling individuals with dementia is essential for developing tailored strategies that address their unique risks. Despite the existing evidence on fall prevention in older adults, few reviews specifically examine the obstacles faced by persons with dementia and their caregivers in community settings. This scoping review, therefore, aims to map the barriers and challenges to preventing falls among community-dwelling individuals with dementia.

Methods and analysis

This review will follow Arksey and O’Malley’s five-stage framework and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist. Six electronic databases (PsycINFO, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Scopus and Embase) will be searched for relevant studies published between 2014 and 2024. Grey literature sources, including dissertations and conference proceedings, will also be included. Data will be charted and synthesised thematically to provide an overview of barriers and contextual factors influencing fall prevention. The study commenced in August 2025 and is expected to be completed by February 2026.

Ethics and dissemination

As this review involves the analysis of existing literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries tailored for healthcare providers and caregiver groups.

Registration details

The protocol is registered with the Open Science Framework: https://osf.io/gnw47/(dataset).

Defining upper extremity dominance: The contributions of hand preference and grip strength

by Mohamadreza Hatefi, Seyedeh Feriyal Mahdavi, Amirreza Abbasi, Farideh Babakhani

Background

Upper extremity (UE) dominance is often defined by self-reported hand preference; however, this may not accurately reflect true functional or strength-based dominance. This study examined the relationship between writing hand, throwing hand, and maximal grip strength to assess how these measures align.

Methods

Thirty-four healthy, recreationally active college-aged individuals reported their preferred writing and throwing hands and completed standardized grip strength testing. Associations among the variables were analyzed using Phi coefficients and chi-square tests.

Results

A moderate, significant relationship was found between writing and throwing hand preference (φ = 0.456; p = 0.008), indicating general consistency across these subjective measures. However, no significant association emerged between grip strength dominance and either writing (φ = 0.027; p = 0.876) or throwing hand (φ = 0.096; p = 0.574).

Conclusion

These results suggest that grip strength dominance may not correlate with commonly used indicators of hand preference, highlighting the need for task-specific definitions of dominance in clinical and athletic contexts. Consequently, employing such task-specific definitions allows for more accurate assessments and enhances the translational relevance of research findings in practical settings.

Epidemiological assessment of mental health screening protocols for high school athlete participation in the USA, 2021

Por: Generoso · R. A. · Vasudevan · V. · Hamade · H. · Sylvester-Omorodion · P. · Wolohan · M.
Objectives

To examine state-level variation in mental health screening practices for high school athletes in the USA and evaluate associations between screening protocols and adolescent depression-related and suicide-related outcomes.

Design

Cross-sectional study of preparticipation examination (PPE) forms and Youth Risk Behaviour Surveillance System (YRBSS) data.

Setting

High school athletics across all 50 US states and the District of Columbia.

Participants

732 676 high school students who completed the 2021 YRBSS survey (grades 9–12).

Primary and secondary outcome measures

Prevalence of depressive symptoms and suicide-related behaviours, measured using YRBSS items on sadness/hopelessness, suicide ideation, planning, attempts and suicide attempts resulting in injury. State-level PPE forms were reviewed for presence and depth of mental health screening, including Patient Health Questionnaire-4 (PHQ-4) and eating disorder (ED) risk questions.

Results

Screening practices varied widely, ranging from no mention of mental health in some states to required evaluations with formal referral protocols in others. Of 732 676 students, 503 861 (68.7%) reported feeling sad or hopeless, 608 416 (83.0%) seriously considered suicide and 64 072 (8.8%) attempted suicide in the past year. States with required screening protocols had higher reported rates of depressive symptoms (71.0% vs 68.7%, p

Conclusions

High school athletes represent a vulnerable group in need of structured and standardised mental health screening. State-level screening policies were associated with lower suicide attempt rates, though causal inference is limited by the cross-sectional design. Standardised use of validated mental health tools may support early identification and intervention for at-risk adolescents.

Overuse of head CT scans in non-traumatic paediatric cases in the West Bank, Palestine: a cross-sectional study

Por: Hamad · S. · Ahmad · Y. · Saymeh · A. A. A. · Ghanayim · M. · Taha · S. · Alawneh · M. · Alawneh · M. · Damiri · B.
Background

Overuse of CT scans is associated with multiple harms, such as an increased risk of cancer development, particularly in children. However, the rate of CT scan use is high and unwarranted worldwide.

Objectives

This study aimed to identify the patterns and reported indications for head CT scans ordered for non-traumatic paediatric cases in Palestine.

Design

This was a retrospective, cross-sectional study based on a desk review.

Setting

The study was carried out from June 2024 to September 2024 in five hospitals located in five major Palestinian governorates in the West Bank.

Participants

The study included records of children aged 14 or younger, presenting with non-traumatic complaints and having undergone head CT between January 2020 and September 2024. A total of 3715 patient records were explored, of which 2977 were included in the final analysis; 1764 (59.3%) males and 1213 (40.7%) females.

Primary and secondary outcome measures

A pilot review of 100 records was conducted, and the data collection spreadsheet included demographic and clinical characteristics, presentations, reported reasons for CT requests, CT results, and information on lumbar puncture (LP) performance.

Results

The mean age of patients was 4.3 years (SD±3.3), with 59.3% aged 3 to 11 years, and 47.7% presenting to hospitals in northern governorates. The most commonly reported presentation was fever and convulsion (8.2%), followed by convulsions (7.7%), and a combination of fever, headache and vomiting (6.5%). Only 12.9% of the CT scans yielded positive findings, including dilated ventricles (19.3%), sinusitis (18.8%), brain oedema (12.9%), and brain mass (11.1%). Most CT scans were requested to check for contraindications to LP, with only 4.1% having a positive CT finding indicating a contraindication. At the multivariate level, a positive CT result was associated with being a neonate, having a past medical condition, ordering CT to check for contraindication to LP and presenting with convulsions.

Conclusions

CT scans were found to be overused without justification, particularly for ruling out contraindications to LP. The development of clear and specific national guidelines is recommended. This process can be supported through training, decision support tools, alternative management pathways and specialist consultations to ensure compliance. Additionally, enhancing reporting quality and using health information systems are vital for monitoring and improving radiological safety.

Multicancer early detection in a cohort of patients with confirmed and suspected cancer by measuring plasma amino acid cross sections with the Enlighten test: MODERNISED protocol

Por: Wilding · S. · Goss · V. · Sukdao · W. · Hamady · Z. · Lord · J. · Coleman · A. · Pointer · C. · Walters · J. · Herbert · W. · Mclaughlin · K. · Waugh · R. · Irvine · N. · Oliver · T. · Soulsby · I. · Hooper · J. · Crabb · S. J. · Griffiths · G. · Yates · E. · Davies · A.
Introduction

Detecting cancer earlier improves treatment options and long-term survival. A multicancer early detection test that reliably picks up early-stage cancer would potentially save lives and reduce the cost of treating cancer. One promising candidate is the Enlighten test, which applies machine learning to plasma amino acid concentrations to detect cancer. In a cohort of 77 patients recently diagnosed with breast, colorectal, pancreatic or prostate cancer, 60 (78%) were detected by the test (sensitivity), with no false positives in 20 healthy controls. The MODERNISED study will further develop the Enlighten test to detect 10 different cancers by adding bladder, lung, melanoma, oesophageal, ovarian and renal cancer to the test.

Methods and analysis

MODERNISED (ISRCTN17299125) is a multicentre prospective, non-interventional, case–control study. We aim to recruit 1000 adult participants with a recent cancer diagnosis, 250 adult participants with symptoms of cancer where a cancer diagnosis was ruled out by the National Health Service (NHS) standard of care and 100 healthy adult volunteers. Cancer tissue of origin (ToO) will include bladder, breast, colorectal, lung, melanoma, oesophageal, ovarian, pancreatic, prostate and renal. Participants in the two non-cancer cohorts who are later diagnosed with cancer will be moved to the cancer cases cohort. The primary aim is to train and validate a machine learning algorithm to detect cancer, which will be evaluated by AUROC. Secondary aims include training and validating an algorithm to predict ToO and stage of cancer, exploring differences in performance by demographics and estimating how sensitivity varies across specificity cut-offs of 95%, 99% and 99.9%. These results will provide a statistically powered estimate of how well the Enlighten test can discriminate between individuals with and without cancer, which can then be validated for clinical use in further research.

Ethics and dissemination

This study is sponsored by University Hospital Southampton NHS Foundation Trust and has been approved by the Health Research Authority and Health and Care Research West Midlands (24/WM/0234). Results will be presented at scientific meetings and published in international peer-reviewed journals. Lay summaries of study progress and findings will be published on the Southampton Clinical Trial Unit’s website.

Trial registration number

ISRCTN17299125.

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