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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.

Non-inferiority of saline versus corticosteroid injections for trapeziometacarpal osteoarthritis: a protocol for a pilot and feasibility randomised controlled trial

Por: Gevers-Montoro · C. · Freire · V. · Harris · P. G. · Ruel · M. · Luong · D. H. · Bureau · N. J. · Bois · M.-C. · Aribert · M. · Efanov · J. I. · Filali-Mouhim · A. · Piche · M. · Hamasaki · T.
Introduction

Trapeziometacarpal osteoarthritis (TMO) is among the most prevalent forms of upper extremity osteoarthritis. It is frequently associated with significant levels of pain and disability, particularly among ageing women. The typical care pathway for TMO relies on non-surgical approaches for up to 2 years, before surgery is considered. One of the most common non-surgical approaches is an intra-articular cortisone injection. However, these are not universally recommended due to their safety profile and unclear efficacy compared with saline injections. Recent evidence suggests that saline might be non-inferior to cortisone, but this remains to be clarified. This pilot trial aims to assess the feasibility of a trial examining the non-inferiority of saline compared with cortisone injections for TMO.

Methods and analysis

This trial will recruit 40 adults with a diagnosis of TMO and a prescription for a cortisone injection from the Centre hospitalier de l’Université de Montréal (CHUM), Canada. Participants will be randomised to receive either an intra-articular injection of 0.9% sodium chloride (experimental arm, n=20) or triamcinolone acetonide (standard of care, n=20) under fluoroscopic guidance at the Radiology Department or under ultrasound guidance at the Physiatry Clinic. Opaque syringes will be used to blind participants and physicians. Feasibility outcomes, collected at all time points, will include recruitment rates, follow-up completion rates and blinding indices. Preliminary efficacy outcomes, collected at baseline and at 1 day, 1 month, 3 months and 6 months post-injection, will include pain intensity (0–10 scales), hand function (QuickDASH 11-items), cumulative analgesic consumption scores, concurrent interventions, adverse events and number of participants receiving a second injection or an arthroplasty. Descriptive statistics will be used to present feasibility outcomes. Preliminary data on the effectiveness of saline and cortisone injections will inform the design of a large-scale study for formal hypothesis testing.

Ethics and dissemination

The trial was approved by the CHUM Human Research Ethics Board (2025-11815). The research output will be presented at conferences and published in a peer-reviewed journal.

Trial registration number

NCT06401317.

Primary caregivers practices and perceptions on antibiotic use and resistance: a one health qualitative study in rural South India

Por: Charan · K. · Lakshmi Kandhan · V. · Rishika · R. S. · Kalimuthu · P. · Pon Ruban · A. C. · Karthikeyan · M. B. · Sahoo · K. C. · Ponnaiah · M. · Chethrapilly Purushothaman · G. K. · Diwan · V.
Objectives

Antimicrobial resistance is a growing global public health threat driven by interactions between human, animal and environmental factors. Rural settings in low- and middle-income countries may face increased risk due to unregulated antibiotic use, close human–animal interactions, and environmental contamination. This study explored community-level knowledge, attitudes and practices related to antibiotic use and resistance among caregivers of children in rural South India using a One Health perspective.

Design

Qualitative study using focus group discussions and thematic analysis.

Setting

Four rural villages in Tirunelveli district, Tamil Nadu, India.

Participants

Seventy-seven primary caregivers of children aged 2–12 years from households with backyard animals, purposively selected from a rural cohort study.

Results

Three themes emerged. First, human health practices included reliance on home remedies, reuse of prescriptions, self-medication and incomplete antibiotic courses alongside misconceptions about antibiotics. Second, environmental factors such as untreated water consumption, open defecation, poor drainage and improper waste disposal were perceived to increase infection risks. Third, animal-related pathways included close child–animal contact, antibiotic use in livestock and unsafe disposal of animal waste. Limited healthcare access and transport costs influenced treatment-seeking behaviour.

Conclusions

Interconnected caregiver practices, environmental conditions and animal husbandry behaviours create multiple pathways for antimicrobial resistance transmission. Integrated, community-based interventions addressing behaviour change, healthcare access and environmental management are essential to support antibiotic stewardship within a One Health framework.

Predicting depressive and anxiety symptoms among Lebanese and Syrian adults in a suburb of Beirut, Lebanon, during concurrent crises: nested cross-sectional study

Por: Shamas · H. · Ragi · M.-E. · Abi Zeid · B. · DeJong · J. · McCall · S. J. · CAEP Study Group · Germani · El-Jardali · Ghattas · M Melhem · DeJong · McCall
Objective

This study aimed to develop prediction models for symptoms of poor mental health among Lebanese adults and adult Syrian refugees or migrants residing in a suburb of Beirut, Lebanon, separately.

Design

Nested cross-sectional study.

Setting

Sin-El-Fil, a suburb east of Beirut, Lebanon.

Participants

Lebanese and Syrian adults residing in low socio-economic status areas of Sin-El-Fil.

Primary and secondary outcome measures

Primary outcome was having depressive symptoms, ascertained through the Patient Health Questionnaire-9 where a total summative score of 10 or more indicated having depressive symptoms. Secondary outcome was having anxiety symptoms, ascertained through the Generalised Anxiety Disorder-7 where a total summative score of 10 or more indicated having anxiety symptoms.

Results

Of 1986 participants, 1322 (66.5%) were Lebanese adults, 664 (33.5%) were Syrian refugees or migrants. Among Lebanese adults and adult Syrian refugees or migrants, 324 (25.3%) and 289 (43.9%) had depressive symptoms, respectively. Having pain that impacts usual activity, having debt, not feeling safe at home and having none or one person to count on in difficult times were common predictors of depressive and anxiety symptoms among Lebanese adults and Syrian refugees or migrants. Not having a legal residency permit was also a predictor of depressive symptoms for Syrian refugees or migrants. Prediction models developed for depressive and anxiety symptoms among both nationalities had good performance measures.

Conclusions

The predictors of poor mental health included financial, health and social indicators for both Lebanese adults and Syrian refugees or migrants during the concurrent crisis in Lebanon. These models are most applicable in similar urban, crisis-affected and low-resource settings. Findings emphasise the need for social protection and financial support among populations with vulnerabilities.

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.

Preventive interventions for preschool children at risk for emotional and behavioural problems: a scoping review protocol

Por: Anggeriyane · E. · Fitri · S. Y. R. · Dhamayanti · M. · Rakhmawati · W. · Mardya · B.
Introduction

Emotional and behavioural problems (EBPs) are receiving increasing attention at the global level, and preschool children are no exception. These issues have a significant impact on future development. Preventive interventions in preschool age are effective in preventing more serious disorders by improving social skills, emotional regulation and resilience in children. Although various preventive interventions have been developed and their effectiveness demonstrated, the evidence remains fragmented. At present, there has been no comprehensive study mapping EBPs prevention interventions at the preschool age level using the Neuman Systems Model approach.

Methods and analysis

This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews.The completed scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR). A systematic search will be conducted in four major databases, namely Scopus, PubMed, Web of Science, Cochrane Library, and online searches using Google Scholar, without language and publication year restrictions. Two reviewers will independently screen the literature according to the inclusion criteria and then extract the data. Any differences between the two reviewers will be resolved through discussion with a third reviewer. We will compile, summarise and analyse the extracted data and present the results in figures, tables and descriptive narratives to ensure clarity and facilitate comparison across studies.

Ethics and dissemination

Ethical approval is not required, as the review will use only published literature. Findings will be disseminated through publication in a peer-reviewed international journal and may inform policy and practice in early childhood preventive interventions.

Registration

Open Science Framework (https://osf.io/zg6ty).

First population-based study on non-communicable diseases and risk factors in northeastern Iran: Sabzevar cohort profile

Por: Ghorat · F. · Chaman · R. · Javadinia · S. A. · Rad · M. · Mohammadzadeh · M. · Hassanpour · K. · Foroumandi · E. · Nazarzadeh · M. · Saghi · M. H. · Salari · M. · Bidel · Z. · Eghtesad · S. · Gohari · A. · Mohammadi · Z. · Borghabani · R. · Ghorbani · M. M. · Moslem · A. · Norouzi · S.
Purpose

Non-communicable diseases (NCDs) have become the leading cause of mortality globally, with a sharp rise in Iran due to lifestyle changes and urbanisation. Although many NCD risk factors are modifiable, limited understanding of their determinants hinders effective prevention. To address this, the Prospective Epidemiological Research Studies in Iran (PERSIAN) Cohort was established in 2014 to study NCDs nationwide. The Sabzevar PERSIAN Cohort Study (SPECS) is the first in northeastern Iran, aiming to investigate environmental and social factors influencing NCDs in a unique regional context.

Participants

SPECS enrolled 5174 adults (aged 35–70 years) in northeastern Iran between January 2018 and January 2019 through a census and an online registration process. The baseline data collection included demographic verification, informed consent, health questionnaires, anthropometric measurements and biological samples (blood, urine, hair, nails). The annual follow-up began in April 2019, with full reassessments every 5 years over a 15-year period. The data is gathered via an active and passive follow-up, supported by trained staff and registry linkages.

Findings to date

Of the 5174 participants, 4241 (81%) remained in the study. Among the cohort, 54.5% were female, with a mean age of 50.5 years. The majority were married (93.5%), and nearly half had at least high-school education (46.5%) and moderate socioeconomic status (49.4%). Drug abuse history (smoking/drugs) was reported by about 15% of the sample. The mean body mass index was 26.9 kg/m², and the average blood pressure was higher in males (118.1/74.0 mm Hg) than in females (111.5/70.2 mm Hg). The common conditions included hypertension (22.8%), kidney stones (22.4%), fatty liver (15.4%) and diabetes (13.8%). Cancer had the highest treatment rate (100%), while fatty liver had the lowest (70.1%). Stroke had the highest mean age of onset (51.2 years), and epilepsy the lowest (23.7 years). All health data were self-reported.

Future plans

SPECS, part of the national PERSIAN cohort initiative, is the only adult NCD-focused study in Khorasan Razavi. Its 15-year follow-up aims to generate region-specific insights into the incidence of NCDs and their risk factors. The ethnically homogeneous sample enhances statistical power, and the findings may inform culturally tailored health policies. While self-reported data have limitations due to bias, high initial participation and access to free healthcare support long-term engagement, especially among lower-income groups.

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.

Critical risk identification in construction projects using 2D and 3D risk matrices

by Shamal Ali Othman, Dalshad Kakasor Ismael Jaff, Ahmet Öztaş

Construction projects are exposed to numerous risks that may adversely affect project cost and duration. The purpose of this study is to identify and prioritize key construction risks by combining a Work Breakdown Structure (WBS) with a Risk Breakdown Structure (RBS) and analyzing these risks using two-dimensional (2D) and three-dimensional (3D) risk matrices. In total, 63 risk factors were identified and categorized into five main areas of the work breakdown structure: earthwork, concrete, finishing, mechanical, and electrical. The questionnaire was designed based on each risk category and then sent to engineers, who were asked to estimate the risk probability and its impact. In total, 378 engineers responded. The respondents data were analyzed by using the risk matrix method. Two separate 3D risk matrices were made: one was based on multiplying all three data points, and the other was based on combining both impacts. The results clearly show that the 3D matrix, which combines cost and time impact, yields more accurate results than the matrix that multiplies cost impact and time impact.

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.

Attitudes towards supervised consumption sites and e-health overdose response interventions: development and reliability of the Canadian National Questionnaire on Overdose Monitoring (CNQOM)

Por: Rider · N. · Seo · B. · Viste · D. · Rioux · W. · Sedaghat · N. · Pan · B. · Al Hamarneh · Y. N. · McCormack · G. R. · Aghajafari · F. · McDougall · L. · Ghosh · S. M.
Objective

To detail the development of the Canadian National Questionnaire on Overdose Monitoring (CNQOM), a questionnaire aimed at assessing the perspectives of key stakeholders towards elements of overdose prevention interventions—supervised consumption sites (SCSs) and overdose hotlines and applications (ORHAs).

Design

Cross-sectional survey.

Setting

Canadian health system.

Participants

English or French speaking adults from four key informant groups: people who use substances (PWUS), health professionals, emergency responders and the general public.

Outcome measures

Test–retest reliability of CNQOM items.

Methods

A novel questionnaire was developed. Item development followed a standard approach, with face validity verified by representatives from the four informant groups. Input from experts in harm reduction and addiction medicine enhanced content and face validity of the questionnaire. A rigorous response validation approach was undertaken to ensure respondents were human and from Canada. Test–retest reliability items were assessed using Spearman’s rank correlation, Wilcoxon rank-sum test and Cohen’s kappa.

Results

After data cleaning and response validation, 4445 valid responses were obtained from the four key informant groups. Respondents represented a range of sociodemographic backgrounds and housing scenarios from all provinces and territories in Canada. Test–retest reliability was assessed using a small subsample of 142 participants (primarily from general public informants). Questionnaire items demonstrated slight to substantial stability in responses (kappa coefficients: 0.15–0.58; Spearman’s r: 0.08–0.66).

Conclusions

The CNQOM is the first online questionnaire in Canada designed to capture perspectives and attitudes towards specific elements of SCSs and ORHAs among diverse key informant groups. Our questionnaire was administered to a large, geographically diverse sample and designed to capture the perspectives of four key informant groups. Lower than expected test–retest reliability may be explained by lack of participant familiarity with SCS and especially ORHAs and the impersonal nature of the instrument content among some respondents. Future work will elucidate key informant perspectives on these services based on the data.

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.

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