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Titles/Abstracts of Articles Currently Open for Review:

  • Background: Osteoporotic vertebral fractures are a leading cause of pain, disability, and reduced quality of life in the elderly population. Although vertebroplasty is widely used to relieve pain and stabilize fractures, postoperative rehabilitation remains suboptimal, with limited functional recovery. Seated Baduanjin, a modified form of traditional Baduanjin exercise tailored for frail elderly patients, has been successfully applied in the rehabilitation of knee osteoarthritis, cervical spondylosis, and sarcopenia. However, its application in patients after vertebroplasty has not yet been systematically synthesized. Objective: This systematic review and meta-analysis aims to evaluate the efficacy and safety of seated Baduanjin exercise compared with usual care in terms of pain, physical function, and quality of life among elderly patients with osteoporotic vertebral fractures following vertebroplasty. Methods: This protocol has been registered in PROSPERO (CRD420261344980). We will search PubMed, Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Database from inception to July 2026, with no language or date restrictions. Only randomized controlled trials evaluating seated Baduanjin in elderly patients (aged ≥60 years) after vertebroplasty will be included. Two reviewers will independently screen the literature, extract data, assess the risk of bias using the Cochrane RoB 2.0 tool, and evaluate the quality of evidence using the GRADE system. The primary outcome is pain intensity. Secondary outcomes include physical function, quality of life, and balance function. Meta-analysis will be performed using RevMan 5.4. Heterogeneity will be assessed using the I² statistic and Cochran’s Q test: a fixed-effects model will be used when I² < 50% and P ≥ 0.1; if I² ≥ 50% or P < 0.1, subgroup analyses will be conducted. If heterogeneity persists, sensitivity analyses or exploratory subgroup analyses will be performed. Should the heterogeneity remain unexplained, a random-effects model will be adopted, and the GRADE evidence level will be downgraded. Results: As of January 2026, the preliminary screening of titles and abstracts for 241 studies has been completed. Full-text screening is expected to be finalized by May 2026, and data analysis is planned for completion by August 2026. Approximately two-thirds of the relevant studies have been published since 2020. In terms of geographic distribution, the study samples are highly concentrated in Asia. The results will be comprehensively presented around the core outcomes: the primary outcome will be presented as changes in the Visual Analogue Scale (VAS). Secondary outcomes will be assessed using physical function measures such as the Oswestry Disability Index and quality of life scales such as the SF-36 and EQ-5D. The pooled effect sizes with 95% confidence intervals for the corresponding outcome measures will be reported. Additionally, the incidence of adverse events will be statistically analyzed. Conclusions: If the findings of this study confirm the efficacy and safety of seated Baduanjin exercise, it may provide a viable approach for non-pharmacological rehabilitation in elderly patients following vertebroplasty. However, some studies may have a risk of bias, such as insufficient standardization of intervention protocols and difficulty in implementing blinding. Due to variations in intervention protocols, outcome measures, and patient cultural backgrounds, substantial heterogeneity is anticipated. Moreover, the limited number of available original randomized controlled trials and the high geographic concentration of the study samples may restrict the generalizability of the conclusions. Future research should focus on optimizing intervention protocols and supplementing the evidence with high-quality, multicenter, large-sample randomized controlled trials to enhance the reliability of the findings. PROSPERO registration number: CRD 420261344980 Clinical Trial: This systematic review protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-P) guidelines. It has been registered on the International Prospective Register of Systematic Reviews (PROSPERO) platform (CRD420261344980). Any methodological changes during the research process will be recorded and updated in the PROSPERO record.

  • Background: Chronic pain is a leading cause of disability and requires multidimensional assessment of pain intensity and functioning, yet electronic health records (EHRs) rarely capture these measures systematically. By contrast, surveys collecting patient-reported outcomes can assess pain over multiple dimensions but remain resource-intensive and difficult to scale for continuous population-level monitoring. Objective: The objective of this study is to develop and validate a domain-informed natural language processing (NLP) framework to derive pain severity and functional interference outcomes from unstructured clinical narratives. Using a benchmark dataset of 3,726 Veterans with longitudinal survey measures, we aim to demonstrate that NLP-derived outcomes can serve as a reliable, scalable surrogate for resource-intensive patient-reported surveys. Methods: This study utilizes a retrospective cohort of 3,726 Veterans with chronic musculoskeletal pain initiating Complementary and Integrative Health (CIH) therapies across 18 Veterans Health Administration (VA) Whole Health Flagship sites (2021–2023). The dataset encompasses longitudinal patient-reported outcome surveys serving as the benchmark, linked with both structured and unstructured data from the VA EHR. To guide extraction and enable scalable processing, we developed a seed lexicon and annotation guidelines based on established psychometric instruments and input from subject matter experts (SMEs). Currently, SMEs are annotating clinical notes in iterative batches. Upon completion, a large language model (LLM) will annotate additional notes. These annotations will be used to fine-tune a lightweight language model capable of processing the entire cohort. The study employs a three-stage validation process, assessing: (1) documentation completeness; (2) inference accuracy, evaluating agreement between model outputs and SME annotations at both the LLM and fine-tuned model levels; and (3) concordance with patient-reported outcomes captured independently from the EHR. Results: To date, a cohort of 3,726 Veterans has been identified. The longitudinal survey data have been linked to clinical notes corresponding to the survey time period. The seed lexicon and annotation guidelines have been developed. Annotation is underway in iterative batches to drive the subsequent LLM adaptation and three-stage validation. Conclusions: This protocol outlines a framework for identifying severe pain interference from clinical narratives, addressing a critical gap in health care system surveillance. To our knowledge, this is the first study to validate clinical text-based pain outcome extraction against patient-reported outcomes in a nationwide longitudinal cohort. If successful, this approach will enable health care systems to continuously monitor pain-related functional interference and support more holistic, patient-centered pain management at scale.

  • Background: Breast cancer is the most commonly diagnosed cancer worldwide and the leading cause of cancer death among women in low- and middle-income countries (LMICs) (Sung et al., 2021). Survival disparities between high-income and LMICs are largely attributable to late-stage presentation and failure to receive timely, definitive surgery (World Health Organization [WHO], 2023). Health-system barriers—including shortages of trained surgical teams, weak referral pathways, affordability constraints, and limited theatre availability—prevent many eligible patients from accessing mastectomy or breast-conserving surgery. While a range of health policy and system-level interventions have been implemented, the evidence base remains fragmented and unsynthesised. Objective: To identify and synthesise evidence on health policy and health-system interventions implemented and evaluated in LMICs to improve access to definitive breast cancer surgery, and to assess their effects on: (1) receipt/coverage of indicated surgery; (2) timeliness of surgery; and (3) surgical service availability/capacity, including implementation and equity considerations where reported Methods: This is a pre-registered systematic review protocol (PROSPERO CRD420261333028). We will search CENTRAL, Embase, PubMed, Scopus, LILACS, Web of Science, and grey literature sources from January 2000 to March 2026 with no language restrictions. Evaluative quantitative, qualitative, and mixed-methods studies of implemented interventions will be included. Risk of bias will be assessed using RoB 2 (Sterne et al., 2019), ROBINS-I (Sterne et al., 2016), CASP, and MMAT 2018. Synthesis will follow a structured narrative approach using the WHO Health System Building Blocks framework, with meta-analysis where feasible. Certainty of evidence will be rated using a GRADE-informed approach. Results: This section will be completed upon review completion (target: 15 June 2026). Results will be presented in accordance with PRISMA 2020 guidelines and will include: a PRISMA flow diagram documenting records identified, screened, and included; a summary of included study characteristics; risk of bias assessments across all included studies; and a structured narrative synthesis of intervention effects, organised by the WHO Health System Building Blocks framework. Where sufficient homogeneity permits (≥3 comparable studies), meta-analytic results will be reported with pooled effect estimates, confidence intervals, and heterogeneity statistics (I², Cochran's Q). GRADE evidence profiles will be presented for primary outcomes. Conclusions: This systematic review will provide the first comprehensive synthesis of health policy and health-system interventions targeting access to definitive breast cancer surgery in LMICs. By mapping the evidence base across all three primary outcome domains — receipt of surgery, timeliness, and service availability — and situating findings within the WHO Health System Building Blocks framework, the review is designed to produce actionable intelligence for policymakers, health system planners, and international funders. Findings will be disseminated through peer-reviewed publication in English and will be aligned with the WHO Global Breast Cancer Initiative implementation framework. The review addresses a critical accountability gap: as international investment in LMIC breast cancer surgical programmes grows, there is an urgent need for rigorous evidence on what works, for whom, and under what contextual conditions. Results are expected to directly inform programme design, resource allocation decisions, and future research priorities in global cancer surgery. Clinical Trial: PROSPERO (CRD420261333028)

  • Background: Pterygium and cataract frequently co-exist in populations with high ultraviolet light exposure, particularly in rural India. Both conditions impair visual acuity and reduce quality of life. Simultaneous small incision cataract surgery (SICS) combined with pterygium excision offers the advantages of a single surgical session, faster rehabilitation, and lower cost compared with sequential procedures. However, SICS employs a superior scleral tunnel incision of 6.5 to 7 mm, which itself induces against-the-rule surgically induced astigmatism. The net astigmatic outcome of simultaneous SICS and pterygium excision has not been prospectively characterised in a resource-limited setting. Objective: This protocol describes a prospective, single-arm interventional study designed to quantify the change in magnitude and axis of corneal astigmatism from baseline to Day 30 following a protocol-defined simultaneous surgical intervention consisting of manual SICS with posterior chamber intraocular lens implantation followed by primary nasal pterygium excision using the bare sclera technique in a single operative sitting. Methods: This is a prospective, single-arm interventional study with within-participant comparison conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, DMIHER (Deemed University), Wardha, India. All enrolled patients (n=100, aged ≥35 years with visually significant cataract and grade 1–2 nasal primary pterygium) receive the standardised surgical intervention: manual SICS with posterior chamber IOL implantation followed by primary nasal pterygium excision using the bare sclera technique in a single operative sitting. Sample size (n=100) was calculated using McNemar’s test for paired proportions, assuming 9.45% preoperative and 31.49% postoperative prevalence of clinically significant astigmatism (>1.0 D, a threshold representing astigmatism that commonly warrants spectacle correction), with α=0.05 and 95% power (minimum n=88), adjusted for 10–15% attrition. The primary outcome is change in keratometric corneal astigmatism (diopters and axis) from baseline to Day 30. Secondary outcomes include Alpins vector analysis of surgically induced astigmatism, correlation of pterygium size with preoperative astigmatism, change in uncorrected and best-corrected visual acuity, refractive surprise rate, pterygium recurrence, patient satisfaction (pilot-tested questionnaire), and complications. Follow-up assessments occur at Day 1, Day 15, and Day 30. Results: Ethical approval for the study was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research on June 30, 2025. Participant recruitment began on November 1, 2025 and is ongoing at Acharya Vinoba Bhave Rural Hospital, Wardha. Data collection is expected to continue through 2027, with results anticipated to be reported in 2028. Conclusions: This protocol will generate prospective interventional data evaluating corneal astigmatism and visual outcomes of a protocol-defined simultaneous surgical procedure combining manual SICS and bare sclera pterygium excision in a high-volume rural ophthalmology setting. Findings will inform surgical planning, IOL power selection strategies, and patient counselling in resource-limited settings where SICS is the predominant cataract surgical technique. Clinical Trial: Clinical Trials Registry of India (CTRI): CTRI/2025/10/095785; Registered October 9, 2025 (Prospective).

  • Ocular Biometric and Fundus Characteristics in High Myopia: A Hospital-Based Cross-Sectional Study Protocol

    Date Submitted: Mar 28, 2026
    Open Peer Review Period: Apr 1, 2026 - May 27, 2026

    Background: High myopia (spherical equivalent refractive error (SER) ≤ -6.00 diopters (D)) is a major global cause of visual impairment associated with structural ocular complications including myopic macular degeneration, retinal detachment, glaucoma, and cataract. Structural alterations including axial elongation, corneal remodeling, and fundus changes remain incompletely characterized across varying degrees of high myopia in Indian tertiary care settings. Objective: To evaluate ocular biometric parameters and fundus characteristics in patients with high myopia and examine their association with the severity of myopia. Methods: This hospital-based cross-sectional observational study will be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital (AVBRH), Jawaharlal Nehru Medical College (JNMC), Datta Meghe Institute of Higher Education and Research (DU) (DMIHER), Wardha, India. A minimum of 140 participants aged 10 to 50 years with high myopia (SER ≤ -6.00 D in at least one eye on cycloplegic refraction) will be consecutively enrolled over 2 years. Participants will undergo standardized ophthalmic assessment including best-corrected visual acuity (BCVA; converted to logMAR for analysis), cycloplegic refraction confirmed by autorefractometry, slit-lamp biomicroscopy, automated keratometry, ultrasound pachymetry, contact A-scan biometry, and dilated fundus examination. Fundus findings will be graded using the Meta-Analysis for Pathologic Myopia (META-PM) classification. Data normality will be assessed by the Shapiro-Wilk test. Associations between refractive error severity and ocular parameters will be evaluated using Pearson or Spearman correlation coefficients. Group comparisons will be conducted using one-way analysis of variance (ANOVA) or Kruskal-Wallis tests. Categorical comparisons will use the chi-square test. Inter-eye correlation will be addressed using generalized estimating equations (GEE). All analyses will be performed in SPSS version 23. Results: The study has received ethical approval from the Institutional Ethics Committee (IEC) of DMIHER (DU) (Ref. No. DMIHER(DU)/IEC/2025/393; July 9, 2025). Participant enrollment commenced in January 2026 and is ongoing. Results are anticipated for publication by 2027 to 2028. Conclusions: This study will provide region-specific data on ocular biometric and structural changes in high myopia to inform evidence-based clinical monitoring and management strategies. Clinical Trial: Registered with the Clinical Trials Registry of India (CTRI/2025/12/099253; registered December 16, 2025).

  • Association between cardiovascular disease and cataract: A protocol for systematic review and meta-analysis

    Date Submitted: Mar 29, 2026
    Open Peer Review Period: Mar 29, 2026 - May 29, 2026

    Background: Emerging evidence suggests shared pathophysiological mechanisms between cataracts and cardiovascular disease (CVD), indicating a potential link between these two prevalent non-communicable diseases. Oxidative stress, resulting from an imbalance between reactive oxygen species production and the body's antioxidant defenses, contributes to lens protein aggregation in cataracts and lipid oxidation in atherosclerosis, a key feature of several CVD subtypes. This shared pathophysiology implies that systemic vascular health may influence cataractogenesis. However, the epidemiological evidence supporting this relationship remains inconclusive. Objective: The main objective of this systematic review aims to synthesize existing evidence on the risk of developing cataracts in adults with underlying CVD. Methods: This systematic review follows the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and its extension for protocols (PRISMA-P) guidelines. Using the Population, Exposure, Comparator, Outcome (PECO) framework, this review attempts to identify the association between established CVD and the risk of cataract development or the need for cataract surgery. Systematic literature searches are conducted in PubMed, Scopus, Web of Science, and Embase using Medical Subject Headings terms, from database inception to 31 December 2024. Original research articles involving adults (≥18 years) that assess the statistical relationship between CVD and cataracts are included. Two independent reviewers screen studies, extract data, and appraise studies’ quality using the Newcastle-Ottawa Scale. Meta-analyses are conducted using random-effects models to calculate pooled effect estimates, with heterogeneity assessed using the I² statistic. Results: By October 2025, the systematic review had been successfully completed in accordance with PRISMA guidelines. Comprehensive database searches identified relevant studies examining the association between cardiovascular disease (CVD) and cataract development or the need for cataract surgery. Conclusions: This systematic review provides a consolidated and up-to-date evaluation of the relationship between CVD and cataracts. The findings highlight the potential importance of integrating cardiovascular risk assessment into routine ophthalmologic care. Continued refinement of study methodologies and standardisation of outcome measures are needed to address observed heterogeneity and strengthen future evidence, ultimately supporting more holistic management of patients with coexisting cardiovascular and ocular conditions. Clinical Trial: This systematic review has been registered with PROSPERO (CRD42025629907) and the Ministry of Health Malaysia (NMRR ID-24-03414-99G).

  • Background: Antimicrobial resistance (AMR) poses a growing and serious threat to patient safety worldwide. Nurses, as the largest professional group in the global health workforce, play a central role in antimicrobial management. However, their contributions to antimicrobial stewardship (AMS) programmes remain poorly characterised and inconsistently measured. To date, no systematic review has combined a meta-analysis of the clinical effectiveness of nurse-led or nurse-involved AMS interventions with an implementation-focused synthesis to inform policy, practice, or future research. This gap is particularly relevant for the Gulf Cooperation Council and the Middle East and North Africa (GCC/MENA) healthcare systems, where the burden of AMR is high, and evidence of nursing contributions to AMS is limited. Objective: This protocol describes a convergent, parallel-streams mixed-methods systematic review to determine: (1) the effectiveness of nurse-led or nurse-involved antimicrobial stewardship (AMS) interventions on patient and antimicrobial outcomes in hospital and primary care settings globally; (2) the barriers and facilitators to implementing nurse-led AMS interventions or programmes; and (3) synthesis GCC/MENA evidence via sub-group analysis Methods: The review will follow the JBI convergent, parallel-streams mixed-methods methodology. Eleven databases will be searched from January 2000 to April 2026. The review will include primary research comprising: (1) quantitative studies (Stream 1), including randomised controlled trials, quasi-experimental studies, interrupted time series, and controlled before-and-after studies reporting clinical or process outcomes of nurse-led or nurse-involved AMS interventions. Where appropriate, meta-analysis will be conducted using a random-effects model. Outcomes will include antibiotic consumption, prescribing appropriateness, mortality, hospital length of stay, time to first antibiotic dose, and blood culture collection rates. (2) qualitative studies (Stream 2), which will be synthesised using thematic analysis guided by the Consolidated Framework for Implementation Research (CFIR 2.0) to identify barriers and facilitators of implementation. Findings from both streams will be integrated using a convergent joint display. Eight pre-specified subgroup analyses are planned, including comparisons between GCC/MENA countries and the rest of the world, and between intensive care and general ward settings. The certainty of evidence for quantitative outcomes will be assessed using GRADE. The review is registered with PROSPERO (CRD420261341653). Results: The protocol was registered with PROSPERO. Database searches are scheduled to commence in April 2026. Full-text screening is expected to be completed by June 2026, with data extraction and synthesis anticipated by October 2026. The completed systematic review to be submitted for publication in January 2027. Conclusions: This review will provide the first meta-analytic synthesis of the clinical effectiveness of nurse-led AMS, alongside a structured implementation analysis using CFIR 2.0. The findings will inform antimicrobial stewardship programme design, nursing education, and health policy, with particular relevance for GCC/MENA healthcare systems. Clinical Trial: PROSPERO: CRD420261341653; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=1341653

  • Background: African Americans (AAs) experience higher rates of hypertension (HTN) and related cardiovascular and stroke mortality compared with the general U.S. population. Interestingly, studies have shown that AAs take more antihypertensive medications but are less likely to adhere to the prescribed medication regimens compared to the general population. Additionally, participants in qualitative studies have expressed that HTN self-management, particularly lifestyle modifications, should receive more attention than increasing medications. Objective: The objectives of this study are: 1) to evaluate the synergistic effect of a pharmacist and community health worker (Pharm+CHW) intervention compared to a Pharmacist alone (Pharm control group) to improve blood pressure (BP) control in a predominantly AA cohort aged ≥ 55 years in a prospective randomized trial (n=480); 2) to identify factors correlated with clinical BP outcomes. Methods: This is a randomized clinical trial to investigate novel behavioral intervention strategies targeting HTN self-management (e.g., medication management, blood pressure monitoring) and lifestyle modifications. The study has two components: a pharmacist-led medication management component (Pharm) and a community health worker support component (CHW). In the Pharm component, pharmacists will provide virtual Medication Therapy Management (MTM) services, which include: a comprehensive medication review, recommendations for lifestyle modifications, blood pressure self-monitoring education, and medication management app education. In the CHW component, CHW will support participants’ self-initiation of behavioral change(s), address challenges to lifestyle modification, and provide health education through workshops. The study intervention will be guided by a Community Advisory Board (CAB) consisting of six members. The study will recruit a cohort of 480 predominantly AA adults 55 years or older with HTN through community-and faith-based organizations and clinics in Houston, Texas, U.S. Participants will be prospectively randomized to one of the two parallel groups: 1) Pharmacist alone (control group; n=240); or 2) Pharmacist and CHW interventions (Pharm+CHW; n=240) for 24 months. Computer-generated randomization, with 1:1 allocation stratified by age, recruitment site, and HTN stage, will be applied. The primary self-monitoring BP outcome will be measured at 0-, 6-, 12-, 18-, and 24-months to evaluate the effectiveness of the proposed interventions. The secondary outcomes will include medication adherence, hypertension knowledge, perceived competency, body mass index, and physical activity. Results: The study was funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health under award number 2U54MD007605 in September 2025. The CAB has convened and offered support for recruitment efforts. Recruitment is ongoing, and the intervention is expected to begin in summer 2026. Conclusions: This project will fill an important knowledge gap regarding the synergistic effect of CHWs working in collaboration with pharmacists to help older adults use technologies (e.g., virtual visits, mobile medication management apps) and initiate lifestyle modifications for HTN self-management in older adult AAs. Clinical Trial: NCT07413159

  • Artificial Intelligence (AI) in Psychiatry for Improving Continuity of Patient Care; Systematic Review Protocol

    Date Submitted: Mar 23, 2026
    Open Peer Review Period: Mar 25, 2026 - May 20, 2026

    Background: Continuity of care—defined as coherent, connected services across providers—is critical for psychiatric patients with chronic conditions but challenged by fragmentation at primary-secondary-community interfaces, poor data interoperability, and transitions. AI/ML tools (e.g., predictive algorithms for relapse, NLP for data synthesis, chatbots for engagement, digital phenotyping) promise to enhance informational, relational, and managerial continuity by automating monitoring, triaging high-risk cases, and bridging care gaps. Despite growing applications, no rigorous synthesis evaluates their efficacy, typologies, patient experiences, or implementation factors in psychiatry. Objective: This PROSPERO-registered systematic review will assess AI/ML interventions' effectiveness vs. standard care for continuity in adult psychiatric care; categorize AI architectures; synthesize patient-reported outcomes (PROs); and identify ethical/implementation barriers/facilitators. Methods: Guided by Cochrane Handbook and PRISMA-P, we will search MEDLINE, Embase, Cochrane CENTRAL, CINAHL, PsycINFO (2016–2025), trial registries (ClinicalTrials.gov, ICTRP), and references. PICO: P adults ≥21 years with primary psychiatric diagnoses; I any AI/ML for post-encounter continuity (prediction, NLP, chatbots); C standard care (case management, ACT, non-AI reminders); O readmissions, follow-up latency, adherence, attrition, PROs/satisfaction; designs: RCTs, cohorts, qualitative/mixed-methods (English, peer-reviewed). Dual independent screening/extraction in Covidence (pilot-tested, ≥80% agreement); data extraction for study characteristics, PICO details, effect sizes (RR/HR/means/SD); author contact (3 attempts) for missing data. Risk of bias: RoB 2.0 (RCTs), ROBINS-I (NRSIs), CASP (qualitative). Synthesis: random-effects meta-analysis (RevMan) if homogeneous (I²<50%); narrative/thematic otherwise; GRADE for certainty; funnel plots/Egger's for publication bias (≥10 studies); sensitivity analyses for imputation/heterogeneity. Results: We expect AI/ML to reduce readmissions (RR 0.7–0.9) and improve adherence via proactive tools, with barriers like privacy/clinician resistance and facilitators like workflow integration. Conclusions: Findings will map multi-level (patient/community/system) applications, guide equitable AI deployment in resource-constrained systems like Singapore's, and inform policy for person-centered psychiatric care. Clinical Trial: PROSPERO CRD420251245352

  • Background: Age-related macular degeneration (AMD) is the leading cause of irreversible central vision loss in adults aged 50 years and above. In rural India, its true burden remains substantially underestimated because prior prevalence data relied exclusively on fundoscopy, without confirmatory imaging. The Central India Eye and Medical Study (CIEMS, 2011) reported early AMD in 8.3% of adults aged 60 years and above in rural Wardha, yet no subsequent OCT- or FFA-confirmed estimate exists for this population. Objective: This study has three primary objectives: (1) To estimate the imaging-confirmed prevalence of AMD among adults aged 50 years and above attending a rural tertiary care hospital in Central India; (2) To identify demographic, behavioural, and systemic factors independently associated with AMD in this population; and (3) To characterise patterns of diagnostic delay and barriers to eye care in patients with AMD. Methods: A hospital-based cross-sectional study will be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027, providing a 12-month enrolment period. A minimum of 126 participants will be enrolled through consecutive sampling supplemented by community screening camps. AMD will be graded by two masked retinal specialists using AREDS criteria, with spectral-domain OCT (Cirrus HD-OCT 5000, Carl Zeiss Meditec, Dublin, CA, USA) and fundus fluorescein angiography as confirmatory modalities. The primary outcome is age- and sex-adjusted AMD prevalence. Secondary outcomes include risk factor associations (multivariable logistic regression), diagnostic delay (median delay with nonparametric comparison between recruitment pathways), and visual acuity at first presentation. Inter-grader agreement will be quantified using Cohen's kappa. Results: The study was registered with the Clinical Trials Registry of India (CTRI/2026/03/106075) on 12 March 2026. Participant recruitment will begin on 20 March 2026 and continue until 19 March 2027 at Acharya Vinoba Bhave Rural Hospital, Wardha, Maharashtra, India. As this manuscript describes the study protocol, no participants have yet been enrolled. Data analysis is expected to begin in mid-2027, with dissemination of results anticipated in late 2027. Conclusions: This study will generate the first imaging-confirmed AMD prevalence data for rural Central India since 2011. Systematic quantification of smokeless tobacco exposure, occupational sunlight, and diagnostic delay will provide actionable evidence for integrating AMD screening into India's National Programme for Control of Blindness and Visual Impairment. Clinical Trial: Clinical Trials Registry of India - CTRI/2026/03/106075 (registered 12 March 2026)

  • Identification of training needs and development of a work-integrated training program for aged care onsite pharmacists: a co-design protocol.

    Date Submitted: Mar 22, 2026
    Open Peer Review Period: Mar 23, 2026 - May 18, 2026

    Background: Aged Care Onsite Pharmacist roles are progressively rolling out across Australia. Distinct from pharmacist practice in hospital and community pharmacy, the role is professionally isolated from other pharmacists, limiting opportunities for peer learning and collaboration, and practice-specific professional development. Objective: To co-design a training program that enhances the professional practice of aged care onsite pharmacists in line with the diverse interests of stakeholders. Methods: Focus group-style co-design workshops and stakeholder consultations will be employed in this project. The ‘Double-Diamond’ framework will be employed to structure the process, using four stages of alternating convergent and divergent exploration of stakeholder perspectives. A consumer advisory group has been engaged, consisting of persons with lived experience of aged care settings, for consistent observation and overarching guidance of the project. Exploratory workshops with pharmacists, allied health and medical professionals, residents, and families of residents will be conducted. Workshops will be audio- and video-recorded, transcribed verbatim and undergo thematic analysis. Insights obtained from overarching themes as well as individual perspectives will be used to design a pilot program, which will be presented and discussed for feedback during follow-up focus groups. A pilot phase will then be undertaken with aged care onsite pharmacists, who will be further involved in feedback and workshop-style focus groups to collaboratively refine the program. Results: Focus group-style workshops and oversight from a consumer advisory group will guide the development of a novel education intervention for practising aged care onsite pharmacists in Australia. Conclusions: This will be the first co-designed workplace-based training program available for pharmacists undertaking the novel, complex role of aged care onsite pharmacists. It is expected to be of benefit for developing clinical and non-clinical skills, facilitate integration into existing teams, and offer a pathway to professional recognition. Clinical Trial: Ethical approval was sought and obtained through the Adelaide University Human Research Ethics Committee (Approval #206543). All participants will provide informed consent prior to participation. The study is conducted in accordance with the National Statement on Ethical Conduct in Human Research (2023). This research was funded through the Medical Research Future Fund (MRFF) 2022 Quality, Safety and Effectiveness of Medicine Use and Medicine Intervention by Pharmacists (Grant ID: MRFMMIP000022).

  • Background: Cigarette smoking remains highly prevalent among people living with type 2 diabetes mellitus (T2DM) and is independently associated with accelerated cardiovascular disease, worsened microvascular complications, and premature mortality. Despite strong evidence supporting pharmacological and behavioural cessation interventions, the integration of structured tobacco treatment into routine diabetes care remains inconsistent across healthcare systems. Furthermore, ongoing controversies surround the potential role of tobacco harm reduction (THR) strategies—including electronic nicotine delivery systems (ENDS)—for individuals who are unable or unwilling to achieve complete abstinence from tobacco. Objective: This protocol describes an international, modified Delphi study designed to generate expert consensus on optimising smoking cessation care and on the place of THR approaches in the management of T2DM, and to prioritise pragmatic, evidence-informed recommendations for clinical practice and future research. Methods: A multidisciplinary Steering Committee will develop a structured set of consensus statements informed by the DiaSmokeFree evidence base and framed using PICO-oriented questions across eight clinical domains. We will recruit 30–50 international experts from relevant scientific societies and clinical disciplines. Participants will complete two to three anonymous online rating rounds over approximately two to three months. Each statement will be rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Consensus will be defined a priori as ≥85% of respondents rating within a single agreement category (1–2, 3–4, or 5–6). Statements not reaching consensus will be revised on the basis of quantitative feedback and free-text comments and re-rated in subsequent rounds. Ethics and dissemination: Ethical approval will be sought where required by local regulations. Participation is voluntary with informed consent. Results will be reported in accordance with the Conducting and REporting DElphi Studies (CREDES) guidance and disseminated as an open-access consensus statement, a suite of practical clinical tools, and a prioritised research agenda to support the integration of evidence-based tobacco treatment and harm reduction into T2DM care.

  • Background: Reviewing the prescription drug monitoring program (PDMP) before signing a controlled medication prescription is a best practice to improve opioid safety and is legislatively mandated in most states. Mandating provider actions have unintended costs including workflow interruptions and misapplying provider time. The evidence supporting PDMP effectiveness is mixed, exacerbating the knowledge gap regarding mandating PDMP use. Prior PDMP evaluations have been limited by low rates of PDMP use and an inability to link encounter level PDMP review with patient outcomes. Clinical decision support (CDS) is an effective implementation strategy which is advantageous in collecting clinical data on PDMP use and prescribing decisions. Objective: This study aims to evaluate if user-centered CDS, which imports PDMP data into existing workflows, improves PDMP use and patient safety while reducing provider work. Methods: This is an electronic health record (EHR)-embedded, randomized control trial of 2 clinician-facing active choice CDS alerts to facilitate mandatory PDMP review vs usual care. One CDS, “mandated alert,” interrupts providers when prescribing an opioid or benzodiazepine with a link suggesting providers open the EHR-integrated state PDMP interface. Results: Utilizing user-centered design, we developed a second “smart” mandated CDS with the same rules-based logic and suggestion to check the PDMP, but also displays patient-specific data imported from the PDMP (number of active narcotic, sedative, and stimulant filled prescriptions). The aim of adding PDMP data to CDS is to facilitate PDMP utilization while decreasing unnecessary provider work when additional PDMP information is not needed. Providers were randomized and balanced by setting (349 inpatient, 354 emergency department and 751 outpatient). Both CDS alerts will be implemented within a single health system with a shared EHR and compared to usual care (no CDS). The primary outcome will be PDMP use. Secondary outcomes will be evaluated relative to encounter level PDMP use and include time spent prescribing, controlled medication prescription completion, and future opioid use by patients. Conclusions: This is a study protocol for a pragmatic, EHR-embedded randomized clinical trial optimizing a CDS implementation strategy to improve PDMP utilization while decreasing provider work. Implementation and effectiveness outcomes will be examined using the RE-AIM framework. Clinical Trial: NCT06215560 registered 5/6/24

  • Background: Chronic liver disease (CLD) is a major public health burden, particularly among middle-aged men with metabolic risk factors such as obesity and type 2 diabetes. Although sustained lifestyle modification is critical for preventing disease progression, long-term self-management in this population is often suboptimal. Mobile health interventions show promise for supporting self-management; however, most are patient-centered and rarely incorporate structured family engagement despite evidence highlighting the importance of social support. Objective: This study aims to develop and formalize a protocol for a family-supported digital health coaching intervention for middle-aged men with CLD and metabolic risk factors and to evaluate its feasibility and acceptability prior to effectiveness testing. Methods: This parallel-group randomized controlled trial, approved by the Institutional Review Board of Y University Health System (Approval No. 4-2025-0117) and sponsored by Y University Health System, will be conducted in Seoul, Republic of Korea. Eligible participants are men aged 40–64 years with CLD for ≥6 months and at least one metabolic risk factor; key exclusions include decompensated cirrhosis and active malignancy within 5 years. A total of 82 patient–family dyads (164 participants) will be randomized (1:1) to either a 12-week smartphone-based intervention grounded in the Information–Motivation–Behavioral Skills model or usual care. The primary outcome is change in Nonalcoholic Fatty Liver Disease Self-Management Questionnaire score from baseline to 12 weeks. Secondary outcomes include perceived social support (MSPSS), depressive symptoms (PHQ-9), family experience (FIES:CI), sleep quality (PSQI-K), and clinical indicators derived from electronic medical records, including body mass index, waist circumference, aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, triglycerides, high-density lipoprotein cholesterol, and glycated hemoglobin as applicable. Data will be analyzed using repeated-measures analysis to evaluate group-by-time effects under an intention-to-treat framework. Results: Expert content validation demonstrated excellent validity (Content Validity Index = 1.00). Usability testing indicated high acceptability (System Usability Scale mean 86.88, standard deviation 7.58). The finalized protocol operationalizes information, motivation, and behavioral skills within a structured digital platform incorporating dyadic family involvement. Enrollment began in May 2025 and is expected to be completed by March 2026. Conclusions: This protocol describes the development of a family-supported digital intervention for CLD management and provides a framework for evaluating family-centered self-management strategies in middle-aged men with metabolic risk factors. Clinical Trial: Clinical Research Information Service (KCT0010494), registered on March 25, 2025. Secondary identifiers: none. Individual participant data will be available upon reasonable request following publication.

  • Background: Type 2 diabetes mellitus (T2DM) has become a major health burden worldwide, therefore strategies to manage it in early stages are continuously being investigated. Excessive calorie consumption and sedentary lifestyles which are accompanied by the development of a low-grade inflammatory state, are one of the key risk factors for the development of prediabetes, metabolic syndrome and the subsequent T2DM. Lifestyle modifications like intermittent fasting (IF) have become an important aspect in the management of T2DM. Current evidence on the effects of IF on low-grade inflammation in individuals with either prediabetes, metabolic syndrome or T2DM is inconsistent. This systematic review protocol outlines the planned synthesis and evaluation of existing literature investigating the effectiveness of IF on inflammatory markers of adult patients with prediabetes T2DM or metabolic syndrome. Objective: The main objective of this review is to analyse data of previously published studies investigating effects of different IF regimens by assessing inflammatory markers of patients with prediabetes, metabolic syndrome or T2DM. Methods: This protocol is prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol (PRISMA-P) 2020. Databases including PubMed/Medline, PubMed Central, Scopus and Google Scholar will be systematically searched for published randomized controlled trials and longitudinal studies, including cohort, case-control, cross-sectional, observational, retrospective and prospective studies involving all types of intermittent fasting in adult humans with prediabetes or T2DM OR metabolic syndrome. Eligible participants will be adults (≥18 years) diagnosed with metabolic syndrome, prediabetes or T2DM using the American Diabetes Association (ADA) or the World Health Organisation (WHO) criteria. Systematic reviews, conference abstracts, editorials and meta-analyses will be excluded. Additionally, studies without a control group will be excluded unless they provide baseline vs. follow-up inflammatory data. The control group in randomized controlled trials will consist of subjects on their usual diet, continuous energy restriction or standard diabetic care. Active comparators like Mediterranean diet will be allowed if inflammatory markers are reported. Data on changes in inflammatory markers between the intervention and control group, as well as between baseline and post intervention will be extracted. The extracted data will be verified by a second reviewer and disagreements will be resolved by a third reviewer. The risk of bias of the included randomized controlled trials will be assessed using the Cochrane Risk of Bias 2 (RoB 2), while for longitudinal studies the National Institutes of Health (NIH) quality assessment tool for Before-After (Pre-post) studies with no control group will be used. Review Manager (RevMan) will be used to perform a meta-analysis where sufficient data are available and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to assess the quality of evidence. Results: This review will only use publicly available published data. The findings of this review will provide a comprehensive synthesis of the current evidence regarding the effects of intermittent fasting regimens on inflammatory markers of adult patients with either T2DM, prediabetes or metabolic syndrome. Conclusions: The findings will highlight the current knowledge gaps and inform future clinical research, which may help to guide early intervention strategies to manage prediabetes or metabolic syndrome and to prevent the onset of T2DM. Clinical Trial: International Prospective Register of Systematic Reviews (PROSPERO) CRD420251133867, https://www.crd.york.ac.uk/PROSPERO/view/CRD420251133867

  • Background: Population aging is rapidly reshaping the Brazilian labor force, increasing the participation of adults aged 50 years and older and intensifying the need for safe, inclusive, and age‑friendly workplaces. Preventive behaviors at work play a vital role in protecting workers’ physical, social, and psychological health; however, no validated Brazilian Portuguese instrument is currently available to measure their frequency. The Preventive Behaviors at Work Frequency Scale (Échelle de Fréquence des Comportements Préventifs au Travail), developed in Canada, evaluates how often workers adopt six key preventive behaviors grounded in the Model of Preventive Behaviors at Work. A culturally adapted and psychometrically validated version is therefore needed to support occupational health research, surveillance, and evidence‑based interventions for Brazilian older workers. Objective: This study aims to describe the protocol for the cross-cultural adaptation and psychometric validation of the Brazilian Portuguese version of the Preventive Behaviors at Work Frequency Scale for workers aged 50 years and over. Methods: This methodological study will be conducted based on international guidelines for cross-cultural adaptation and questionnaire validation and will be completed in six steps: (1) forward translation, (2) forward translation synthesis, (3) back translation, (4) harmonization and expert appraisal of relevance, (5) pretesting with the target population, and (6) field testing and psychometric evaluation. Data collection will take place remotely with Brazilian workers aged 50 years and over during a 12‑month period, beginning in winter 2026. Results: Steps 1 and 2 were completed in February 2026, and step 3 (back‑translation) began in March 2026, alongside preparations for step 4. The study is progressing according to the established methodological timeline. Field testing and psychometric evaluation are expected to be carried out between spring–fall 2026, with preliminary results anticipated in winter 2026. Conclusions: This study will produce the first Brazilian Portuguese version of the Preventive Behaviors at Work Frequency Scale, enabling the assessment of preventive behaviors among older workers and strengthening occupational health research and practice in Brazil. The adapted instrument is expected to support cross‑national research, inform evidence‑based workplace interventions, and contribute to the promotion of safe, inclusive, and sustainable work participation among aging workers.

  • Background: Intravenous fluid therapy is widely used in emergency departments (ED) to treat hypovolemia but is invasive and associated with potential complications. Oral fluid therapy represents a non-invasive alternative; however, evidence regarding its feasibility and ability to achieve prescribed fluid volumes in ED patients remains limited. Objective: To evaluate the feasibility of oral fluid therapy in ED patients requiring fluid replacement and to determine whether oral fluid therapy is non-inferior to intravenous fluid therapy in achieving prescribed fluid volumes. Methods: This investigator-initiated, multicenter, open-label randomized controlled feasibility and non-inferiority trial will enroll 250 adult ED patients prescribed ≥1000 ml intravenous crystalloid therapy. Participants are randomized 1:1 to receive either oral fluids or intravenous crystalloid. The primary feasibility outcome is protocol adherence. The primary clinical outcome is the proportion of patients achieving the prescribed fluid volume during the ED stay, analyzed using a non-inferiority framework. Secondary outcomes include total fluid volume received, blood pressure changes, hospital-free days, peripheral intravenous catheter use, acute kidney injury, severe electrolyte imbalance, and additional feasibility measures. Analyses will follow the intention-to-treat principle. Results: Recruitment began in October 2025 at three Danish EDs and is ongoing. As of March 2026, we have enrolled 85 patients. Conclusions: This trial will evaluate whether oral fluid therapy is feasible in ED patients and whether it can achieve prescribed fluid volumes comparable to intravenous therapy. The findings will inform the design of a future definitive effectiveness trial. Clinical Trial: ClinicalTrials.gov ID NCT07361952

  • Background: Breast cancer surgical and reconstructive decision-making is a complex, preference-sensitive process that requires patients to balance oncologic safety, aesthetic outcomes, recovery burden, and long-term quality of life. Despite the growing emphasis on shared decision making (SDM), existing patient decision aids (PDAs) in breast reconstruction are often static, text-heavy, and insufficiently responsive to individual patient values and emotional needs. Artificial intelligence (AI) offers an opportunity to develop adaptive, patient-centered decision-support tools that integrate clinical evidence, patient narratives, and personalized feedback. Objective: This study protocol describes the development and early feasibility testing of an AI-supported, narrative-driven digital decision aid designed to facilitate shared decision-making for patients considering breast cancer surgery and reconstruction. Methods: A multiphase mixed-methods design will guide development and preliminary evaluation. Phase I involves qualitative semi-structured interviews with breast cancer patients and clinical stakeholders to identify key informational needs, emotional challenges, and experiential factors influencing decision-making. Interview transcripts will undergo inductive thematic analysis to inform the conceptual framework, content structure, and narrative integration of the decision aid. Phase II is a pilot mixed-methods feasibility study involving 50 patients with early-stage breast cancer considering surgical and reconstructive options. Participants will use the digital decision aid and complete validated measures including the Decisional Conflict Scale and Decision Regret Scale, along with investigator-developed usability and acceptability assessments. Semi-structured exit interviews will provide qualitative feedback on usability and perceived value. Results: Findings will inform refinement of the decision aid and guide the design of future effectiveness trials. Conclusions: This study outlines a rigorous, stakeholder-informed framework for developing an AI-supported decision aid for breast cancer surgical decision-making. If successful, this approach may enhance shared decision-making and serve as a model for ethically grounded AI-supported decision tools in other preference-sensitive clinical contexts.

  • Exit Interviews in Health Professions Education: a Scoping Review Protocol

    Date Submitted: Mar 13, 2026
    Open Peer Review Period: Mar 13, 2026 - May 8, 2026

    Background: The healthcare workforce is facing numerous challenges, with retaining skilled, qualified, and experienced practitioners being paramount. Exit interviews are a long-established practice with evidence of effectiveness across a range of settings, but are rarely implemented among health professionals. Research on the use of exit interviews mirrors this pattern. This scoping review will address this gap by systematically mapping the use of exit interviews in the literature on health professionals and trainees. Objective: This protocol describes the scoping review process, with a primary question: What is known about the use of exit interviews in health professions education? Methods: This review will follow the Joanna Briggs Institute methodology and will report using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The review will involve systematic searches of academic and grey literature databases. The review will include any studies that utilise or describe exit interviews in the context of health professions education, broadly defined. No data limit will be applied. Titles, abstracts, and full texts will be screened in a two-stage process. At each stage, an initial pilot stage of 10% of identified sources will be reviewed by two independent screeners. A Kappa score indicating substantial agreement (0.61-0.80) will be required before the remaining screening can be completed by a single reviewer. This will be supported by the Rayyan systematic review management platform. Data extraction will be performed by one reviewer and checked by a second, with disagreements resolved by consensus. A further AI-powered verification of data extraction will be performed. The findings will map existing approaches, highlight research gaps and inform future research using exit interviews. Results: No results as this is a protocol. Conclusions: Ethics and Dissemination This scoping review will use publicly available data; therefore, no ethical approval is required. The findings from the completed review will be submitted for publication in a peer-reviewed journal and for presentation at relevant conferences. Clinical Trial: This protocol is registered on the Open Science Framework: https://doi.org/10.17605/OSF.IO/PT2RX

  • Background: : Diabetic patients undergoing cataract surgery face heightened risks due to compromised corneal endothelium, impaired healing, and poor pupillary dilatation. The choice of ophthalmic viscosurgical device (OVD) during phacoemulsification may significantly affect surgical outcomes in this vulnerable population; however, comparative evidence remains limited. Objective: This study aims to compare surgical outcomes of sodium hyaluronate ophthalmic solution (Hyloject) versus hypromellose ophthalmic solution USP (Hyprosol) as OVDs in topical phacoemulsification among diabetic patients with cataract at a tertiary care centre in central India. Methods: This is a prospective comparative non-randomised interventional study to be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, Maharashtra, India. A total of 174 diabetic patients (87 per group) aged above 40 years with senile cataract undergoing phacoemulsification will be enrolled using alternate sequential allocation. The primary outcome is change in corneal endothelial cell density assessed by specular microscopy; secondary outcomes include visual acuity recovery, intraocular pressure changes, and postoperative complications, all assessed preoperatively and at day 1, day 15, and 1 month postoperatively. Results: The study protocol was approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Deemed to be University) on July 9, 2025 (Ref. No. DMIHER(DU)/IEC/2025/370), with a subsequent amendment approved on February 21, 2026 (Ref. No. DMIHER(DU)/IEC/2026/018). The study was registered with the Clinical Trials Registry India on October 15, 2025 (CTRI/2025/10/096085). Enrollment commenced in November 2025; as of March 5, 2026, 35 participants have been enrolled, with 13 allocated to Group 1 (sodium hyaluronate) and 12 to Group 2 (hypromellose); the remaining participants are awaiting surgery and postoperative follow-up. Data collection is projected to be completed by August 2027, with final results expected to be submitted for publication by October 2027. Conclusions: This study is expected to provide comparative evidence on the safety and efficacy of two commonly used OVDs in diabetic cataract surgery, informing evidence-based selection of viscoelastic agents to optimise outcomes in this high-risk population. Identifying the optimal OVD for endothelial protection in diabetic eyes may carry significant clinical relevance in regions such as India, where the dual burden of diabetes and cataract is substantial and cataract surgery volumes are high. Clinical Trial: Clinical Trials Registry of India (CTRI): CTRI/2025/10/096085. Registered October 15, 2025.

  • Incidence and Anatomical Distribution of Primary Posterior Capsular Opacity During Cataract Surgery in a Rural Population: Prospective Observational Study Protocol

    Date Submitted: Mar 8, 2026
    Open Peer Review Period: Mar 9, 2026 - May 4, 2026

    Background: Primary posterior capsular opacity (PCO) is opacity identified on the posterior capsule immediately after cortical clean-up during cataract surgery, encompasses fibrotic posterior capsule plaque and early lens epithelial cell (LEC)-proliferative changes. In rural populations where advanced cataracts predominate, intraoperative capsular pathology is common yet poorly characterised across cataract morphologies. Existing studies conflate distinct opacity types and rely on unmasked subjective assessment. Objective: This study aims to determine the incidence of primary PCO across all cataract morphologies operated on by a single surgeon at a rural tertiary care centre and to describe its anatomical distribution across posterior capsule zones. Methods: This is a 2-year, prospective, observational, single-surgeon study at Acharya Vinoba Bhave Rural Hospital (AVBR Hospital), Wardha, India. A total of 142 adults (minimum n = 129; 10% attrition allowance) will be enrolled. Intraoperative PCO will be classified as Type A (plaque) or Type B (LEC-proliferative) using a pre-specified decision tree, graded on a 4-point scale (0–3) by two independent masked observers using retroillumination photographs (operating microscope + slit-lamp). EPCO grading will be applied at postoperative day 1, week 6 (±1 week), month 6 (±2 weeks), and month 12 (±1 month). Primary outcome is PCO incidence (Wilson score 95% CI). Secondary outcomes include anatomical distribution, longitudinal best-corrected visual acuity (BCVA in logMAR) by linear mixed-effects model, and 12-month Nd:YAG capsulotomy rate. Multivariable logistic regression will adjust for surgical technique, IOL type and edge design, cataract morphology, and age. Missing data will be handled by multiple imputation (MICE). Results: Ethics approval was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Ref: DMIHER(DU)/IEC/2025/374) on June 30, 2025. The study was prospectively registered with the Clinical Trials Registry of India (CTRI/2025/11/097770) on November 20, 2025. Participant recruitment began in November 2025 at Acharya Vinoba Bhave Rural Hospital, Wardha, India. As of March 2026, recruitment is ongoing. The planned recruitment period is 24 months, with a target sample size of 142 participants. Data collection is expected to conclude by late 2027, and the final study findings are anticipated to be published in 2028. Conclusions: This protocol provides a rigorous, objectively graded, morphology-stratified framework for characterising intraoperative capsular pathology in a rural Indian cataract population, with direct implications for surgical planning and Nd:YAG resource allocation. Clinical Trial: Clinical Trials Registry of India (CTRI/2025/11/097770) on November 20, 2025

  • Background: Cochlear implantation (CI) is a highly effective intervention for adults with severe-to-profound hearing loss, yet uptake across the United Kingdom remains low despite clear National Institute for Health and Care Excellence (NICE 2019) guidance and well-established clinical benefits. The original Cochlear Implant Referral Criteria Audit (CIRCA-1) identified marked inequities in access to cochlear implants in 2022, with lower referral rates among older adults, males, individuals from socioeconomically deprived areas, alongside those from minority ethnic backgrounds being less likely to be informed of their eligibility for referral. Since then, national awareness initiatives and the expansion of the existing local “CI Champions” scheme have aimed to address these inequities, improve awareness of CI candidacy, and improve the quality of discussions with patients about options for CI referral. Objective: CIRCA-2 is a national, multicentre, retrospective observational audit designed to re-evaluate adult CI referral pathways and measure progress since the first audit cycle. Methods: The study will include adults assessed in secondary-care ENT and Audiology departments between July and December 2025 whose audiometric thresholds meet NICE TA566 criteria. Participating centres will identify eligible patients using the British Cochlear Implant Group (BCIG) Crystal Report within Auditbase, and anonymised demographic, audiometric, and service-level data will be extracted. The primary outcomes are the proportions of patients meeting NICE TA566 criteria who were informed of their eligibility and referred for CI assessment, with comparisons made to CIRCA-1 data. Secondary analyses will examine adherence to national standards and predictors of discussion and referral using multivariable modelling. In addition, the study will assess the number of patients within criteria for the COmpAring Cochlear implants with Hearing aids in adults (COACH) trial and those meeting CI criteria in one ear only. Results: Data collection will occur from 1st January 2026 - 31st March 2026 and will be retrospective in nature from the period 1st july - 31st December 2025. As of March 2026, 75 sites had registered for the study. Data analysis is projected to start from April 2026 with results submitted for publication by the end of 2026. Conclusions: By quantifying change over time, CIRCA-2 will provide an updated national picture of CI referral practice, highlight any persisting barriers, and inform future strategies to promote equitable access to CIs.

  • Background: Ocular surface disease (OSD) is a prevalent yet underdiagnosed comorbidity in glaucoma patients undergoing long-term topical therapy. Benzalkonium chloride (BAK), the most commonly used ophthalmic preservative, exerts cytotoxic effects on the corneal and conjunctival epithelium, contributing to tear film instability, goblet cell loss, and chronic inflammation. Despite reported OSD prevalence rates of 30–78% in this population, routine ocular surface screening remains inconsistently implemented in glaucoma clinics. Comprehensive data on OSD burden, clinical subtypes, and treatment gaps in the Indian setting are particularly scarce. Objective: This study aims to determine the prevalence and clinical patterns of OSD among glaucoma patients on topical medications, identify associated risk factors (including preservative exposure, polypharmacy, and treatment duration), compare ocular surface parameters with healthy controls, and document existing gaps in OSD screening and management in a tertiary care ophthalmology setting. Methods: This is a prospective hospital-based comparative cross-sectional study to be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, India, from December 2025 to November 2027. A total of 110 participants (55 glaucoma patients on topical therapy and 55 age-matched controls ≥40 years, accounting for 10% attrition) will be enrolled using consecutive sampling. Ocular surface assessment will include the Ocular Surface Disease Index (OSDI) questionnaire, tear breakup time (TBUT), Schirmer's test, and fluorescein/lissamine green ocular surface staining. The study follows the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) reporting guidelines and has received institutional ethics committee approval (DMIHER(DU)/IEC/2025/375, dated July 9, 2025). The study is registered with the Clinical Trials Registry – India (CTRI/2025/11/098126). A participant flow diagram will be included in the final results manuscript. Results: Ethics approval was obtained (DMIHER(DU)/IEC/2025/375; July 9, 2025). The study is prospectively registered with the Clinical Trials Registry – India. Participant enrolment will commence on December 1, 2025. Final results are anticipated in November 2027. Conclusions: This protocol describes a systematic approach to quantify the burden of OSD in glaucoma patients receiving topical therapy in an Indian tertiary care center. Findings are expected to inform evidence-based screening protocols and guide integrative management strategies that balance intraocular pressure (IOP) control with ocular surface health. Clinical Trial: Clinical Trials Registry – India (CTRI/2025/11/098126; November 26, 2025).

  • Background: Chikungunya virus (CHIKV) is a mosquito-borne arbovirus that causes acute febrile illness frequently associated with severe polyarthralgia and long-term disabling sequelae. In 2024–2025, La Réunion Island experienced a major resurgence of CHIKV transmission after more than a decade without documented autochthonous circulation. The live-attenuated chikungunya vaccine VLA1553 (IXCHIQ®, Valneva) was recently approved based primarily on immunogenicity data and a validated immune correlate of protection. However, real-world evidence regarding vaccine effectiveness, safety, and population-level impact during active outbreaks remains limited. Objective: The CHIK-RE-VAC study aims to evaluate the real-world effectiveness, safety, immunogenicity, and cost-effectiveness of the VLA1553 chikungunya vaccine during an ongoing epidemic on La Réunion Island. Methods: CHIK-RE-VAC is an ambispective, observational, multicenter, phase IV cohort study conducted across hospital and outpatient care clusters on La Réunion Island. Eligible adults are enrolled into vaccinated and unvaccinated groups according to their decision to receive vaccination in accordance with national recommendations. The study integrates both prospective recruitment and a retrospective cohort of individuals vaccinated prior to study initiation. Participants are followed for up to 12 months after vaccination or index date with active surveillance, including weekly symptom monitoring and triggered clinical visits. The primary outcome is vaccine effectiveness against laboratory-confirmed symptomatic chikungunya infection at 6 and 12 months. Secondary outcomes include severe disease, hospitalization, adverse events following vaccination, persistent symptoms, health-related quality of life, vaccine acceptability, and cost-effectiveness. A nested immunogenicity substudy evaluates neutralizing antibody responses and cellular immune responses over time. Statistical analyses will use propensity score–based weighting and generalized estimating equation models accounting for clustering. Results: Recruitment began in April 2025 following the launch of a government-funded vaccination campaign targeting populations at high risk of severe chikungunya. An amendment introducing a retrospective cohort was approved in July 2025 to include individuals vaccinated prior to study initiation and to enhance recruitment and statistical power. As of March 2026, 260 participants have been enrolled across the prospective and retrospective components. Recruitment and follow-up are ongoing. Conclusions: The CHIK-RE-VAC study will provide the first comprehensive real-world evaluation of the effectiveness, safety, immunogenicity, and cost-effectiveness of the VLA1553 chikungunya vaccine during an active epidemic. The findings are expected to inform vaccination strategies, public health preparedness, and policy decisions regarding the deployment of chikungunya vaccines in outbreak settings. Clinical Trial: EU Clinical Trials Register: EU-CT 2025-521307-43-00; ClinicalTrials.gov: NCT06928753.

  • Background: Simulated or standardized patients (SP) have long been a cornerstone of medical education, offering controlled, repeatable, and ethically sound training scenarios. With the rise of skills labs and standardization efforts, SPs have become widely implemented across faculties. However, certain limitations—such as the representation of dynamic or complex clinical conditions—remain. Advances in virtual reality (VR) technology now offer new possibilities to complement traditional simulation formats. While both modalities are well established, little is known about their respective strengths and limitations or the potential for mutual substitution or integration in medical education. Objective: This study investigates the strengths and limitations of VR and SPs in medical education to inform conclusions about their potential complementarity and ability to address training gaps. Methods: This scoping review was conducted in accordance with the JBI methodology and PRISMA 2020 guidelines. A dual search strategy was developed to investigate VR and SP simulations separately across four databases (PubMed, Web of Science, ScienceDirect, and Cochrane Library). Studies were screened independently by multiple reviewers using predefined inclusion criteria. Data extraction and analysis followed a structured, iterative process, with results to be presented in tabular and narrative form. Eligible studies examine the use of VR and SPs in the education of medical students and physicians, with a focus on comparing their respective strengths and limitations across various training contexts. Results: The search strategy is expected to identify studies examining the use of virtual reality versus actor-based simulation in medical education. Results will be reported using a PRISMA flow diagram and summarized in structured tables. Findings will be synthesized narratively and categorized according to advantages, limitations, and distinct characteristics of each simulation modality. If feasible, sub-analyses based on study design, educational setting, or outcome type will be conducted. Conclusions: This scoping review will provide a comprehensive overview of the strengths, limitations, and distinct characteristics of virtual reality and actor-based simulation in medical education. The findings are expected to inform educators and curriculum developers about optimal use cases, identify gaps in the literature, and guide future research on simulation-based training methods. Clinical Trial: not possible as scoping review

  • Background: Simulation-based learning (SBL) constitutes a valuable component of medical training, with immersive 3D simulations and physical simulations being commonly used. Immersive 3D simulation training has been proven to enhance procedural skills and their transfer, whereas physical simulators allow for haptic feedback. However, direct comparative evidence between these two simulation modalities is scarce and often does not address cognitive, motivational and perceived learning outcomes, which also have an effect on learning outcomes. Objective: The objective of this study is to determine the differences in procedural performance alongside cognitive load, motivation, and perceived learning between when teaching novice trainees endourological laser-based procedures using immersive 3D simulation and physical simulation. Methods: We will conduct a single-center, two-group randomized controlled trial with 100 medical students who are currently in their final year of undergraduate medical studies. Each participant will complete one training session on either the immersive 3D simulation or the physical simulator followed by one post-training test on the physical simulator. Technical performance will be assessed using a blinded, Objective Structured Assessment of Technical Skills (OSATS) based composite including efficiency, safety and task completion. Furthermore, we will measure motivation, cognitive load, and perceived learning. To analyze group differences in the primary and secondary outcomes we will use independent sample t-tests. Results: Recruitment will start in September 2026. We will begin with the training sessions and post-training tests in November 2026. We expect to complete data collection by December 2026, and finish analyzing by February 2027. Consequently, we expect to publish the results in April 2027. Conclusions: By integrating technical performance with cognitive, motivational, and perceived learning outcomes this study will clarify not only whether, but also how, immersive 3D and physical simulation differently support learning in endourological training. Furthermore, it aims to inform the evidence-based development of simulation curricula in medical education.

  • Investigating 24-hour movement behaviours in young people with Learning Disabilities in Scotland: A Study Protocol

    Date Submitted: Mar 3, 2026
    Open Peer Review Period: Mar 4, 2026 - Apr 29, 2026

    Background: Physical activity (PA), sedentary behaviour (SB), and sleep play a key role in the health and development of young people (Carson et al., 2016; Chaput et al., 2016; Poitras et al., 2016). This has led to the development of guidelines on PA, SB and sleep for children and young people aged 5-17 years (Health, 2017; Tremblay et al., 2016). Objective: To provide pilot data to capture 24-hour Movement Behaviours (24-hrMBs) of young people with learning disabilities in Scotland and in addition obtain the perceptions of young people’s views on the barriers and facilitators to achieving the 24-hrMBs. Methods: Employing a mixed-methods approach, the study will recruit up to 60 participants aged 12 to 17 years with learning disabilities living in Scotland. 24-hr MBs will be objectively measured for seven days using Actigraph (GT3x) accelerometers. Data from the Actigraph will be complemented by self-reported screen time and sleep data collected from parent and youth diaries. Personalised activity profiles will be generated for young people and their families creating an accessible overview of participants’ 24-hr MBs. Qualitative data will be collected using semi-structured interviews which will help to identify potential barriers and facilitators. The quantitative data will be presented through descriptive analysis and qualitative data will be analysed thematically employing deductive and inductive analysis (Braun & Clarke, 2006). Results: As of March 2026, six schools have been approached, and 47 parent and participant information sheets have been provided. This has led to 21 participants being recruited, and currently 12 participants have provided full data. Conclusions: It is anticipated that this study will help guide future studies and help improve the protocols that are to be adopted with this specialist population. Fundamentally the aim is to gather data to inform the design, implementation and analysis of interventions that support young people with learning disabilities to adhere to the 24-hr MBs. Clinical Trial: Not applicable

  • Background: Alcohol Use Disorder (AUD) affects Punjabi-American communities at disproportionately high rates, yet remains under-researched and under-treated. The "model minority" myth masks significant health disparities among Asian-American subgroups, and aggregated data collection practices obscure the unique cultural, historical, and structural factors shaping AUD in Punjabi-Americans. Cultural stigma, family dishonor (izzat), and a lack of culturally competent services create structural barriers to treatment. Even though evidence indicates the effectiveness of culturally tailored interventions, no rigorous studies have designed or validated intervention models specifically for Punjabi-Americans. Objective: This paper proposes a community-based, mixed-methods study to assess AUD prominence and identify barriers to care among Punjabi-Americans in the San Francisco Bay Area. Drawing on Bronfenbrenner’s ecological systems theory and the framework of structural competency, the study aims to generate empirical evidence for designing culturally informed, evidence-based interventions tailored to community needs, and emphasizing the need for further research. Methods: The study will employ a cross-sectional, mixed-methods design guided by Community-Based Participatory Research (CBPR) principles. A bilingual (English/Punjabi) anonymous survey will be administered to 88–100 self-identified Punjabi-American adults (ages 18+) in the Bay Area, using Web-Based Sampling, Community-Based Recruitment, and Respondent-Driven Sampling. The survey instrument includes 18 questions across 5 domains: demographics, alcohol consumption (AUDIT-C), acculturation (SL-ASIA), treatment attitudes, and macrosystem/microsystem factors. Quantitative data will be processed with SPSS by IBM, and analyzed using descriptive statistics, chi-square tests, and regression analyses. Qualitative data from open-ended responses will be analyzed using thematic analysis guided by structural competency and ecological systems theory. Results: As of February 2026, the study is in the design and community engagement phase. The survey instrument has been developed and is undergoing review. Institutional Review Board (IRB) approval will be sought from the University of California, Berkeley. Data collection is anticipated to conclude by May 2026. Conclusions: This study addresses critical gaps in the literature by applying a structural competency framework to AUD in a Punjabi-American context, connecting critical theory to public health, and using the historically successful Amrit Prachar movement as a precedent for community-based interventions. Findings will directly inform the development of a future Culturally Adapted Intervention and contribute to advocacy for disaggregated health data collection for Asian-American subgroups.

  • Background: Background: People experiencing homelessness (PEH) face high morbidity and unmet health care needs. To address these gaps, healthcare providers across the United States are increasingly adopting “field medicine” models that deliver mobile health services in shelters, homeless encampments, mobile clinics, and other community settings. Despite their expanding use, systematic evaluations of field medicine programs remain limited. Objective: Objectives: This paper describes a protocol for a mixed methods evaluation of field medicine for PEH across Los Angeles (LA) County, California. Methods: Methods: PEH receiving field medicine were recruited into an ongoing longitudinal study of the LA County’s unhoused population; a subset of participants in the existing probability-sampled cohort serve as the comparison group. Using monthly online survey data and a quasi-experimental design, we examine who accesses field medicine, how patients use and perceive care, and its impact on health and service engagement. We also conduct participant observation of field medicine teams to document patient–provider interactions and care coordination and carry out semi-structured interviews with providers, patients, and non-patients. Quantitative survey and qualitative findings will be integrated to identify convergence, complementarity, and explanatory insights. Results: Results: Recruitment of PEH receiving field medicine occurred between August 2024 and October 2025. Among 847 individuals referred from field medicine, 749 were eligible and 436 completed the first monthly survey and were enrolled. For the comparison group, 902 of the 1,413 participants ever enrolled in the existing cohort completed a survey during the field medicine recruitment period and met eligibility criteria. Participant observation included 82 field visits (≈500 hours) across diverse service locations and more than 300 patient–clinician interactions. Semi-structured interviews were conducted with 15 providers, 23 field medicine patients, and 12 non-patients. Conclusions: Conclusions: This study represents one of the first large-scale mixed-methods evaluations of field medicine. With increasing health threats from criminalization, climate-related events, and other socioenvironmental hazards, field medicine may mitigate health risks and improve systems engagement for PEH. Findings will provide rigorous evidence to inform service delivery and policy decisions.

  • Background: Post-infectious cough (PIC) is a distinct subacute condition lasting 3 to 8 weeks, affecting 11% to 25% of patients following a respiratory infection. While recent reviews have addressed acupuncture for chronic cough (>8 weeks), the efficacy and safety of these therapies specifically targeting the transient inflammatory pathophysiology of subacute PIC remain unsynthesized. Current pharmacological interventions often provide limited relief or carry adverse effects. Objective: This protocol aims to evaluate the efficacy and safety of needle-based acupuncture therapies for adults with subacute PIC, compared to conventional medication, sham treatment, or no treatment. Methods: We will search MEDLINE (via PubMed), Embase, CENTRAL, CINAHL, Scopus, AMED, SCI, and five Chinese databases from inception onwards. Randomized controlled trials (RCTs) involving adults (≥18 years) with PIC will be included. To avoid pharmacological confounding, acupoint injection will be excluded. Primary outcomes are the Leicester Cough Questionnaire (LCQ) total score and validated cough severity scales (e.g., Visual Analogue Scale). Two reviewers will independently screen studies, extract data, and assess the risk of bias using the Cochrane RoB 2 tool. A random-effects model will be used for meta-analysis, with results stratified by predefined comparison strata (acupuncture vs sham/placebo, active therapy, or add-on designs). Evidence certainty will be evaluated using the GRADE framework. Results: This protocol was registered in PROSPERO (CRD420251268158). As of February 2026, preliminary database searches have been piloted. Formal study screening, data extraction, and evidence synthesis are scheduled to commence in April 2026. Conclusions: This systematic review will provide rigorously synthesized evidence exclusively for the subacute PIC population, offering targeted clinical guidance that is currently missing from broader chronic cough assessments. Clinical Trial: PROSPERO CRD420251268158; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251268158

  • Background: Fixed orthodontic appliances create new retentive niches that favour dental biofilm accumulation and are associated with enamel demineralization and periodontal inflammation. Beyond these clinical effects, orthodontic treatment may induce shifts in the oral microbial ecosystem (commonly referred to as dysbiosis), potentially influenced by individual host–microbiota interactions. Objective: This study aims to evaluate whether an intensive personalized prevention strategy, added to standard orthodontic care, limits orthodontic treatment–associated microbial dysbiosis, defined as longitudinal quantitative shifts from commensal toward pathogenic microbial complexes, during the first year of fixed orthodontic treatment, compared with standard care alone. Methods: This is a prospective, multicenter, randomized, open-label, parallel-arm interventional study with a 12-month follow-up. Eighty participants aged 12–20 years requiring fixed orthodontic treatment will be randomized in 1:1 ratio to receive either (i) standard care or (ii) standard care plus personalized prevention. The preventive intervention includes repeated oral health education sessions, supervised toothbrushing, dietary education, plaque disclosure, and chairside prophylaxis using a standardized professional protocol. Study visits are scheduled at appliance placement (baseline) and at 3, 6, 9, and 12 months (±10 days). The primary endpoint is the longitudinal change in quantities of selected bacterial and viral species in saliva and dental biofilm assessed using high-throughput microfluidic qPCR. Secondary endpoints include salivary inflammatory profiling (cytokines/chemokines), clinical indices (plaque index, bleeding on probing, white spot lesions), compliance measures (wear of oral hygiene devices and toothpaste consumption by weight), and participant satisfaction. Analysis will follow a modified intention-to-treat approach, complemented by per-protocol analyses. Results: The study will include a 6-month enrolment period with baseline data collection, followed by 12 months of participant follow-up. The total study duration is expected to be 24 months. Data analysis and reporting are planned upon completion of follow-up. Conclusions: PREPERMIO is a randomized interventional study evaluating a personalized preventive strategy during fixed orthodontic treatment using biologically driven longitudinal endpoints. By focusing on microbial homeostasis and bacterial community shifts, and integrating bacterial, viral, and host inflammatory markers, it addresses limitations of prior studies centered mainly on clinical or behavioural outcomes and has the potential to inform future personalized prevention strategies in orthodontics. Clinical Trial: NCT06752902

  • Background. Attention-Deficit/Hyperactivity Disorder (ADHD) affects approximately 3-5% of adults globally, characterized by inattention, hyperactivity, and impulsivity, causing substantial functional impairment across occupational, academic, and social domains. Associations between lifestyle factors, including physical activity patterns, sleep quality and duration, screen time behaviors, dietary intake patterns, anthropometric characteristics, and substance use, remain significantly underexplored in North African populations and require comprehensive international investigation, given the severe limitations in epidemiological data. Understanding these modifiable factors could inform evidence-based interventions to manage symptoms and improve function. Objectives. To (i) estimate adult ADHD prevalence in Tunisia and internationally stratified by presentation type and demographics, (ii) examine associations between comprehensive lifestyle factors and symptom severity across multiple domains, and (iii) employ machine-learning (ML) algorithms to identify complex non-linear patterns and interaction effects between lifestyle variables and ADHD symptomatology across diverse populations. Methods. This two-phase quantitative cross-sectional study will recruit approximately 5,000 Tunisian adults aged 18-65 years in Phase I, followed by 50,000 international participants across North Africa, the Middle East, Europe, and North America in Phase II. Data collection employs a dual-mode approach: Google Forms for digital administration and paper-based questionnaires for participants with limited internet connectivity, with mode selection determined by availability at the time of distribution. The assessment battery comprises validated instruments totaling approximately 130-132 items requiring approximately 28-32 minutes of completion time, including the Adult ADHD Self-Report Scale, the International Physical Activity Questionnaire-Short Form, the Pittsburgh Sleep Quality Index, the Smartphone Addiction Scale-Short Version, the Bergen Social Media Addiction Scale, the Screen Time Questionnaire, Short Food Frequency Questionnaire, and the novel Substance Use Assessment Scale. To accommodate the international sample, all instruments will be offered in English, French, and Arabic, allowing participants to choose their preferred language. Officially validated translations will be used where available. For instruments lacking a validated version, a standardized translation will be employed for this study, with subsequent psychometric validation planned. ML algorithms, including random forests, gradient boosting, and neural networks, represent the primary analytical approach, complemented by multivariable regression for association examination. Expected Outcomes. This protocol provides the first comprehensive adult ADHD prevalence estimates for Tunisia and establishes international baseline cross-cultural data enabling systematic comparisons across geographic regions and healthcare systems. ML identification of complex interaction patterns between lifestyle factors and symptom presentations represents the primary methodological contribution, revealing non-linear relationships and distinct phenotypic subgroups. Findings will inform the development of targeted lifestyle-based interventions addressing modifiable risk factors.

  • Background: Rapid urbanization in India is straining the government's capacity to provide basic amenities such as housing, sanitation, electricity, and water. One group of people who are deeply affected are menstruators where menstrual experiences are shaped by an interplay of deep-rooted cultural norms and emerging socio-political discourse, ranging from stigma to bodily autonomy. In urban slums, referred to as bastis in Telugu and Hindi, this reality is worsened by spatial congestion and limited water, sanitation, and hygiene (WASH) resources. This study is situated in the populous slum colonies of Film Nagar, Hyderabad, where residents navigate precarious living conditions and a scarcity of basic amenities. Despite the surrounding affluence of the media and technology sectors, approximately 80% of the local population resides in these 20 underserved settlements 1. Objective: In this context, we argue that menstrual experiences are profoundly shaped by an interplay of biological, socio-cultural, political, economic, and environmental factors. Accordingly, our research seeks to understand how these intersecting determinants manifest in everyday life to influence the lived reality of menstruators. Methods: Guided by biopolitics and poststructuralist feminism, we take a critical-ethnographic approach to analyze contextual factors shaping the menstrual experiences of slum-dwelling menstruators. This study uses a multi-method data generation strategy including rapport building, participant observations, focus groups, in-depth interviews, and digital storytelling. Frame analysis will be used for data analysis and will occur concurrently with data generation. Results: This proposal describes the research being conducted as part of the primary author’s doctoral dissertation. The doctoral program is funded by the Social Sciences and Humanities Research Council (SSHRC) Doctoral Fellowship (2023–2026), and the data collection component of the study is supported by the International Development Research Centre (IDRC) through the International Doctoral Research Award (2024–2025). The study has received ethics approval from the University of Toronto Research Ethics Board and the institutional ethics committee at the University of Hyderabad, India, in January 2025. As of September 2025, 18 households had been recruited. The final phase of data collection is scheduled for March 2026. Study findings are anticipated to be disseminated and published by September 2027. Conclusions: The novelty of this study is predicated on the use of a multi-method critical ethnographic study design. This study’s findings are expected to 1) highlight the interplay of socio-political, familial, and environmental factors affecting menstrual health and bodily autonomy, and 2) guide government bodies, research institutions, and NGOs in developing context-sensitive policies and programs for menstruators.

  • Background: Chronic kidney disease (CKD) is a progressive, multisystem condition associated with substantial morbidity and mortality worldwide. Patients with established CKD are particularly susceptible to acute clinical deterioration and frequently present to emergency departments with high-acuity conditions. Despite the increasing burden of CKD, real-world data describing emergency presentations and early management practices remain limited, especially in low- and middle-income countries. Objective: The primary objective of this study is to describe the spectrum of clinical emergencies among adults with established CKD presenting to the emergency department. Secondary objectives include documenting initial emergency management strategies and short-term hospital outcomes. Methods: This prospective observational study will be conducted over a two-year period in the emergency department of a tertiary care teaching hospital in central India. Adult patients with a documented diagnosis of CKD presenting with acute renal-related complications will be enrolled consecutively. Data on demographics, clinical presentation, investigations, emergency interventions, and in-hospital outcomes will be collected using a structured case record form. Descriptive statistical analyses will be performed, with exploratory regression analyses conducted where appropriate. Results: This manuscript describes the study protocol. Data collection and analysis will be completed after the study period. Conclusions: Systematic documentation of emergency presentations and early management of CKD-related complications may generate context-specific evidence to inform improvements in emergency preparedness and early clinical decision-making for patients with CKD. Clinical Trial: CTRI/2025/09/094214

  • Background: Despite significant improvements in cancer survival, late complications from oncological treatments remain inadequately managed in routine clinical practice. Standard oncology follow-up prioritizes disease recurrence detection over systematic assessment of treatment-related sequelae, resulting in underdiagnosis of physical, psychological, metabolic, and social complications that substantially impair survivors' quality of life. The temporal dynamics of complication emergence remain poorly characterized, limiting development of evidence-based surveillance schedules. Objective: This study aims to determine the time-specific incidence of 19 predefined treatment-related complications at 1, 6, 24, and 60 months following completion of first-line chemotherapy in adult cancer survivors who achieved complete response. Secondary objectives include characterizing temporal trajectories to identify critical surveillance windows, evaluating the feasibility and performance of a standardized guideline-based referral system integrated within a regional healthcare network, and identifying predictive factors for complication occurrence and timing. Objective: This study aims to determine the time-specific incidence of 19 predefined treatment-related complications at 1, 6, 24, and 60 months following completion of first-line chemotherapy in adult cancer survivors who achieved complete response. Secondary objectives include characterizing temporal trajectories to identify critical surveillance windows, evaluating the feasibility and performance of a standardized guideline-based referral system integrated within a regional healthcare network, and identifying predictive factors for complication occurrence and timing. Methods: PASCA-c is a single-center, prospective, interventional cohort study conducted at Centre Léon Bérard (Lyon, France). Over 36 months, 500 adults aged 18–65 years with complete responses to first-line therapy for lymphomas (Hodgkin/non-Hodgkin), acute myeloid leukemia, testicular germ cell tumors, non-metastatic breast cancer, or sarcomas will undergo systematic screening at 1 month (T1), 6 months (T2), 24 months (T3), and 60 months (T4) post-treatment. Each assessment includes validated questionnaires, biomarker analyses, cardiovascular evaluations, spirometry, and functional performance tests covering 19 complication domains. Clinical decision trees based on French and international guidelines generate standardized referral recommendations. Patients are referred to a regional network of 120+ healthcare professionals for complication management while continuing standard oncological follow-up. The primary outcome is the time-specific incidence of each complication at T1, T2, T3, and T4, distinguishing new-onset cases from persistent complications detected at prior assessments. Results: Patient enrollment began in September 2020 and is ongoing. Final results are anticipated in 2027 upon completion of 60-month follow-up assessments for the last enrolled participant. Conclusions: PASCA-c represents the first large-scale European study systematically evaluating the temporal dynamics of 19 treatment-related complications across multiple cancer types. By characterizing time-specific incidence patterns, this study will identify critical surveillance windows for each complication, informing the development of evidence-based, temporally-optimized survivorship care protocols that can be adapted to diverse healthcare settings. Clinical Trial: The study protocol (version_3_03-15-2022) was approved by the French ethics committee (Comité de protection des personnes Ile de France IV, ID-RCB: 2020-A01130-39). The study is registered on ClinicalTrials.gov (NCT04052126). All participants will be asked to sign and date an informed consent form. The results will be published in peer-reviewed journals and academic conferences. The study data have been declared to the ‘Commission nationale de l'informatique et des libertés’ via the reference methodology MR-001 n° R201-001-006.

  • Increasing Fruit and Vegetable Consumption among Preschool-age Children and their Families: Protocol for the Project V.E.G.G.I.E. Pilot/Feasibility Study

    Date Submitted: Feb 20, 2026
    Open Peer Review Period: Feb 20, 2026 - Apr 17, 2026

    Background: Preschool-aged children (2-5 years) living in households experiencing food insecurity (FI) are at a higher risk of facing health and behavioral issues as well as consuming lower quality diets with fewer fruits and vegetables (FV). Repeated exposures are necessary for children to accept certain commonly rejected/disliked foods, but parents in households experiencing FI may not purchase foods their child does not readily accept. Project V.E.G.G.I.E. (Vegetable Eating Gets Going by Increasing Exposure) aims to address this issue by providing families with FVs at no cost alongside education on evidence-based parent-feeding practices tailored to the needs of preschool-aged children. Objective: This study describes the protocol for the Project V.E.G.G.I.E. pilot/feasibility study. Methods: The Project V.E.G.G.I.E. study includes 20 dyads: parents and their preschool-age children. Families received six boxes of fresh FV biweekly for 10 weeks alongside educational materials on parent feeding practices. Parent surveys and daily diaries were completed at three time points: baseline, post-test (weeks 10-11) and follow-up (4 weeks after intervention). Participants in the intervention group also completed an exit survey to assess the acceptability and utility of the FV boxes across several domains including: quantity, quality, and variety. Standard effect size estimates (Cohen’s d) will be calculated as baseline to post-test and baseline to follow-up analyses. Lastly, both control and intervention participants were invited to complete a qualitative interview to discuss satisfaction with the program. Results: The Project V.E.G.G.I.E. program was funded internally by the Department of BLINDED FOR PEER REVIEW at BLINDED University. Recruitment began in February 2025, and data collection took place from March – July 2025. Data cleaning is underway at the time of submission (February 2026); we expect to submit the outcome/feasibility manuscript in Spring 2026. Conclusions: The results of the Project V.E.G.G.I.E. study will be used to evaluate the feasibility and acceptability of this pilot intervention. Feedback will inform refinement of the Project V.E.G.G.I.E. intervention and study protocol prior to scaling up to a well-powered cluster randomized controlled trial. Implementing programs like Project V.E.G.G.I.E. that provide families with increased access to FV at childcare settings may overcome barriers typically associated with FV initiatives. Providing families with both increased access to FV and education on parent-feeding practices may be more effective at increasing FV consumption among preschoolers than either approach implemented independently.

  • Family Outcomes Associated with Occupational Trauma Exposure in Frontline Workers: A Scoping Review Protocol

    Date Submitted: Feb 20, 2026
    Open Peer Review Period: Feb 20, 2026 - Apr 17, 2026

    Background: Frontline workers are frequently exposed to traumatic and high-stress experiences through their occupational roles. While the psychological impacts for frontline workers themselves are well documented, far less attention has been given to the indirect effects of occupational trauma on their family members. Emerging evidence suggests that trauma exposure may extend beyond the individual worker, influencing the emotional wellbeing, relationships, and functioning of partners, children, and wider family systems. However, this literature remains fragmented across disciplines, occupational groups, and sociocultural contexts. Objective: The aim of this scoping review is to identify, map, and synthesise existing research on the impact of frontline worker trauma on family members. The review will examine how reported impacts vary across frontline occupations and sociocultural contexts, and will identify key gaps to inform future research, policy, and practice. Methods: This scoping review will be conducted in accordance with the PRISMA Extension for Scoping Reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) methodological guidance. A comprehensive search will be undertaken in PubMed (MEDLINE), PsycINFO, CINAHL, Web of Science, and Scopus. Eligible studies will include qualitative, quantitative, and mixed-methods primary research published in English, with no time constrains. Title and abstract screening, followed by full-text screening, will be conducted independently by at least two reviewers, with discrepancies resolved through discussion or consultation with a third reviewer. Data will be charted using a structured extraction framework and synthesised narratively, with findings presented using tables and visual evidence mapping. Results: This review will produce an evidence map describing the range of psychological, relational, and social impacts of frontline worker trauma on family members, the populations and occupational groups studied, and the sociocultural contexts represented. Gaps in the literature will be identified to guide future research priorities. Conclusions: By consolidating and mapping the existing evidence, this scoping review will contribute to an emerging but under-researched field and support the development of family-inclusive policies, services, and interventions for frontline worker populations.

  • Background: Despite Iran’s competitive advantages in medical costs and surgical expertise, the medical tourism industry suffers from fragmented service delivery and a lack of standardized competencies among stakeholders. Objective: This study aims to develop and validate a localized »Skill Enhancement Framework« for Iran’s medical tourism workforce. Methods: A multiphase mixed-methods design is employed. Phase I (Scoping Review) has mapped global competencies. Phase II involves qualitative semi-structured interviews to identify localized needs and socio-economic barriers. Phase III utilizes the Delphi technique to reach expert consensus and validate the final framework. Results: no result Conclusions: By integrating evidence-based findings with expert insights, this protocol provides a methodological roadmap to professionalize the value chain, ensuring the sustainability and global competitiveness of Iran’s medical tourism brand

  • Background: Mental health problems are a significant global health challenge, with the majority manifesting during the crucial developmental phase of adolescence. Factors like childhood abuse, socioeconomic conditions, and hostile school environments worsen the mental health problems among adolescents, resulting in severe consequences, including violence, substance abuse, and reduced academic performance. Schools play a crucial role in implementing mental health interventions, offering unique access to a diverse group of adolescents within their familiar learning environment. Objective: This review aims to synthesize the existing literature on interventions designed to support adolescents facing mental health challenges in secondary schools, including the role of school-based support teams (SBST). Methods: This scoping review will follow the framework established by Arksey and O'Malley (2005) and will adhere to a five-step process: (1) identifying the research topic; (2) locating relevant studies; (3) selecting studies; (4) charting the data; (5) compiling, summarizing, and reporting the findings. Selection of articles will be detailed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-ScR) guidelines. Studies published in English from 2020 to 2025 will be included. A comprehensive search will be done across several databases, including PubMed, Scopus, MEDLINE ULTIMATE, ScienceDirect, Google Scholar, and OpenGrey. Using a standardized tool, two reviewers will independently screen the titles, abstracts, and full texts, and extract data to enhance reliability. If they disagree on something, the third reviewer will mediate to enhance consensus. The selection process for the studies included in the review is scheduled to be completed within a 10-week timeframe. This process will strictly follow the comprehensive guidelines established in the PRISMA-ScR checklist. Results: Preliminary database search has been conducted across four databases, PubMed, Scopus, ScienceDirect, and MEDLINE Ultimate, and a total of 2160 records were identified. Duplicates removal and abstract screening are currently in progress. The study is anticipated to be published in June 2025. Results: Preliminary database search has been conducted across four databases, PubMed, Scopus, ScienceDirect, and MEDLINE Ultimate, and a total of 2160 records were identified. Duplicates removal and abstract screening are currently in progress. Conclusions: This scoping review aims to identify interventions that support adolescents with mental health issues, specifically focusing on Africa, and more particularly on the South African context. This focus will help uncover the cultural and contextual factors that influence mental health interventions in this region. In South Africa, accessing mental health services can be difficult, especially in under-resourced communities. School-based mental health interventions have been recognized as an effective solution, as they can reach many adolescents in a cost-efficient manner. These interventions take place in a familiar environment for adolescents and provide a setting that reduces the stigma associated with seeking mental health services. The findings will provide insights into the range of interventions aimed at supporting adolescent learners in secondary schools. By analyzing current literature, the researchers aim to highlight the different types of school-based interventions available, evaluate their effectiveness, and identify any barriers that prevent adolescents from accessing mental health support. Additionally, the review will explore closely the role of school-based support teams and assess their effectiveness in assisting adolescent learners with mental health problems within the school context. The expected outcome of this scoping review is to deliver a comprehensive overview of mental health interventions intended to support adolescents in secondary schools. Clinical Trial: The complete protocol and supplementary details of the review are publicly accessible via the following URL: https://osf.io/eb3ua

  • Background: The cancer care pathway can cause or accentuate inequalities. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and take them into account throughout the treatment process. The DEFCO (Detection of Social Frailty and Cancer Patient Care Pathway Coordination) tool has been created by a public health research team and industrial engineering research team and has previously shown its validity. The transferability and possibilities of implementation in other structures of this tool, developed in a specialized institution, must now be proven. It is also necessary to evaluate it in terms of impact on the fluidity of care paths and on the social impacts of the disease. Objective: The objective is to assess the implementation of the DEFCO tool for identifying social vulnerability in new centers. Methods: This is a multicenter prospective cohort implementation study using a mixed-methods effectiveness-implementation design to evaluate a complex intervention. This study was conducted in five sequential stages. First, the organizational contexts of each participating center and their capacity to implement the DEFCO tool were assessed. Second, key stakeholders were trained to integrate the DEFCO tool into routine clinical practice. Third, a pre-implementation analysis was conducted using the Consolidated Framework for Implementation Research (CFIR) to identify contextual determinants influencing implementation. Fourth, the DEFCO tool was deployed in each center. Finally, the implementation process and outcomes wereevaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (Re-AIM) framework for quantitative measures, complemented by qualitative assessments guided by the CFIR. Results: This study enrolled 437 patients. In addition, 41 professionals were interviewed prior to the study and 21 following its completion. The results are currently under analysis and are expected to be available in the second half of 2026. The results of this implementation study will provide information on: 1) the effectiveness in real life of the DEFCO tool, the objective of which is to identify social vulnerability in new cancer patients; 2) the impact of the modifications made to the initial tool to adapt to the contexts and the differences in practice according to the populations being cared for and therapeutic practice; 3) the key success factors and the pitfalls to be avoided, interacting with the effectiveness of the tool, 4) the modifications in the representations of social vulnerability and its consequences brought about by the implementation of the tool. Conclusions: Thanks to the implementation study, the generalization of this tool will be accompanied by instructions for use and the contextual elements necessary for optimal operation of the systematic detection of social vulnerability in the care pathway of patients treated for cancer in health care institutions of varying status and activity. Clinical Trial: NCT04015895

  • Background: Digital health interventions, including mobile applications and wearable devices, have emerged as promising tools to promote physical activity (PA) and support chronic disease management in primary care. However, evidence remains limited regarding the real-world feasibility, patient engagement, and integration of these tools into routine family medicine practice, particularly in individuals with metabolic syndrome. In addition, physicians’ attitudes and intentions toward telemedicine may influence the successful adoption of such interventions. Objective: This study aims to evaluate the preliminary effectiveness of a mobile health intervention for PA monitoring in individuals with metabolic syndrome managed in primary care. Secondary objectives include assessing user engagement and adherence to the intervention, changes in PA-related and clinical outcomes, and exploring family physicians’ attitudes and behavioral intentions toward telemedicine. Methods: This is a two-arm, parallel, pilot randomized controlled trial conducted in primary care units in the Coimbra region, Portugal. Eligible adults with metabolic syndrome will be randomized (1:1) to an intervention group receiving access to a mobile application integrated with an activity-tracking wristband or to a control group receiving usual care. Data will be collected at baseline and 6 months. Primary outcomes include changes in PA levels and physical literacy, assessed through validated questionnaires and objective analitical results. Secondary outcomes comprise health-related quality of life, cardiometabolic parameters, adherence and engagement metrics derived from app usage, retention and dropout rates. Physicians’ attitudes and intentions regarding telemedicine will be assessed using the Physician Attitudes and Intention to use Telemedicine (PAIT) questionnaire. Analyses will primarily be descriptive and exploratory, aiming to inform the design of a future full-scale trial. Results: Participant recruitment is planned to begin in July 2025. This pilot trial will generate data on feasibility, adherence, engagement, and preliminary behavioral and clinical outcomes associated with the use of a mobile PA monitoring intervention in primary care. Conclusions: This study will provide important insights into integrating mobile health applications for PA promotion among individuals with metabolic syndrome in routine primary care. The findings will inform future larger randomized controlled trials and contribute to implementation strategies for digital health interventions in family medicine. Clinical Trial: EECC-2024_4-220 e 335/25 CE

  • Background: Mental rotation, the ability to mentally transform visuospatial representations, supports everyday spatial behaviors (e.g., navigation) and can be vulnerable in later life. Older adults with mild cognitive impairment (MCI) often show greater difficulties in visuospatial processing than cognitively unimpaired peers, including lower accuracy and higher variability in mental rotation tasks. Because MCI represents a prodromal stage associated with elevated risk for subsequent dementia, the critical period occurring before rapid cognitive decline to dementia, it may be an important window for interventions that target specific cognitive vulnerabilities. In non-amnestic forms of MCI (MCI-NA), visuospatial and/or executive deficits can be prominent, and longitudinal outcomes are heterogeneous, varying in part by underlying neuropathology. Accordingly, interventions that are explicitly designed to engage visuospatial processes relevant to MCI-NA may be a useful, deficit-targeted approach to evaluate in feasibility studies and to inform future controlled trials for cognitive training programs aiming to prolong daily functioning and reduce suffering. Objective: This study aims to evaluate the feasibility and acceptability of the Virtual Reality-Visuospatial Cognitive Training (VR-VCT) program in older adults with MCI-NA and to estimate preliminary within-subject changes in visuospatial cognition to inform a future randomized trial. Participants (n=40) will meet eligibility criteria consistent with commonly used definitions of MCI-NA, including subjective cognitive concerns, preserved basic activities of daily living, absence of dementia, and objective impairment on standardized measures emphasizing visuospatial and/or executive functioning. This study aims to: (1) quantify the feasibility and acceptability of VR-VCT in older adults with MCI-NA, and (2) estimate preliminary within-subject change on visuospatial cognitive outcomes following VR-VCT. Methods: 40 Participants with MCI-NA will be enrolled in a structured VR Cubism program using the Meta Quest 3 VR headset. The intervention will involve three 30-minute sessions per week for 12 weeks, with tasks progressing in difficulty over time. Cognitive and visuospatial outcomes will be assessed at baseline (T0), immediately post-intervention (T1), and at follow-up (T2; 12 weeks post-intervention) to evaluate whether observed changes are maintained. Global cognition will be assessed using the Montreal Cognitive Assessment (MoCA). Visuospatial construction will be assessed using the Wechsler Adult Intelligence Scale (WAIS) Block Design subtest, and mental rotation will be assessed using the Vandenberg Mental Rotation Test (VMRT). Changes in performance across time points will be analyzed using repeated-measures models (e.g., linear mixed models) to estimate within-subject change, with effect sizes and confidence intervals reported to inform future controlled trials. Results: Participants will be recruited from local assisted living facilities, memory care settings, and community outreach programs. This study has been approved by the University of Utah School of Medicine Institutional Review Board. The data collection will be started in March 2026. Data analysis is anticipated to be concluded by August 2026. Conclusions: The findings will inform the study design, outcome measurement, and power calculations of a future randomized controlled trial. If feasible and acceptable, VR-VCT may represent a scalable, engaging, and deficit-targeted intervention approach with the potential to support visuospatial cognitive functioning during a critical window prior to dementia onset.

  • Background: Sexual and gender diverse (SGD) populations experience inequities in health and in health professional education. Mapping how inclusive pedagogical practices address sexual and gender diversity in pre‑registration nursing and midwifery education will clarify current approaches and gaps. Objective: To map how sexual and gender diversity is addressed through inclusive pedagogical practices in pre-registration nursing and midwifery education globally. Methods: This protocol follows the JBI guidance for scoping reviews and the PRISMA‑ScR reporting checklist. We will search CINAHL, MEDLINE, PubMed, Scopus, and Web of Science, plus targeted grey literature. Two reviewers will independently screen titles/abstracts and full texts and chart data using a piloted form. Data extraction will include pedagogical practices addressing sexual and gender diversity (teaching strategies, curriculum content, simulation, assessment), theoretical or conceptual frameworks, outcomes or indicators (knowledge, attitudes, skills, confidence, learning environment), and any identified equity considerations (attention to gender identity and sexual orientation, intersectionality). Synthesis and presentation of findings will be completed using the Patterns, Advances, Gaps, Evidence for practice, Research (PAGER) recommendations framework. The planned start for performing the scoping review is May 2026. Results: Results are expected to inform curriculum development and guide future systematic reviews. Conclusions: This review will provide a comprehensive map of inclusive pedagogical practices addressing sexual and gender diversity in pre‑registration nursing and midwifery education, identify gaps, and inform curriculum development and educator training. Clinical Trial: The review will adhere to PRISMA‑ScR. The protocol has been registered on the Open Science Framework (OSF).

  • Background: Type 2 respiratory failure (T2RF) is a common and high-risk presentation in the emergency department (ED). Non-invasive positive pressure ventilation (NIPPV) is a standard first-line therapy for T2RF, particularly in acute exacerbations of chronic obstructive pulmonary disease and cardiogenic pulmonary edema. However, NIPPV has limitations including discomfort, claustrophobia, air leaks, skin injury, and aspiration, which may compromise tolerance and lead to treatment failure or escalation to endotracheal intubation. High-velocity nasal insufflation (HVNI), particularly via a single-prong asymmetric cannula configuration, has been proposed to enhance dead-space washout and improve patient comfort. Despite growing interest, robust evidence evaluating HVNI in heterogeneous, all-cause T2RF populations in the ED remains limited. Objective: This study aims to determine whether HVNI delivered via a single-prong nasal cannula is non-inferior to standard NIPPV in improving ventilation among adult ED patients with T2RF from any cause. Methods: This is a single-center, open-label, non-inferiority randomized controlled trial conducted in the ED of a tertiary academic center. Adults 21 years and above with T2RF defined as PaCO2 >45 mmHg and pH <7.35, requiring ventilatory support, will be randomized 1:1 to HVNI with single-prong cannula or standard NIPPV. Allocation will be concealed via an independent web-based platform using variable block sizes (4 and 6). The primary outcome is percentage change in PaCO2 from baseline to 60 minutes after initiation of therapy. Eighty-four patients provide 80% power, one-sided alpha 2.5% assuming standard deviation 6.65% and non-inferiority margin 4.3%. Analyses will use intention-to-treat and per-protocol approaches, and sensitivity analyses to address missing arterial blood gas results. Predefined failure criteria (persistent or worsening acidosis, rising PaCO2, refractory hypoxemia, severe intolerance, clinical deterioration) would trigger crossover or escalation per protocol. Results: Recruitment commenced in 2026 at the study site and is ongoing. Data analysis will be undertaken following completion of enrollment. Conclusions: Should HVNI with single-prong cannula be shown to be non-inferior to NIPPV, it may offer a practical alternative to treatment of T2RF in the ED when mask-based interfaces are poorly tolerated or contraindicated, potentially reducing the need for more invasive interventions like endotracheal intubation and mechanical ventilation. Clinical Trial: This trial was prospectively registered on 15 July 2025 with ClinicalTrials.gov (#NCT07065656).

  • Background: Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder that causes chronic pain and functional impairment, particularly among middle-aged and older adults. In early-stage KOA, patients often exhibit reduced periarticular muscle strength and compromised joint function. Without timely intervention, the condition may progress to irreversible structural damage. In Traditional Chinese Medicine (TCM), this stage frequently corresponds to the Liver-Kidney Deficiency pattern, characterized by insufficient nourishment of tendons and bones and diminished muscular function—representing a critical window for therapeutic intervention. Herbal fumigation and Blood Flow Restriction Training (BFRT) each offer advantages in improving local circulation and enhancing muscle strength, respectively; however, clinical evidence for their combined application remains insufficient. Objective: This study aims to systematically evaluate the clinical efficacy and safety of Zhang’s Formula No. 2 fumigation combined with BFRT in middle-aged and elderly patients diagnosed with early-stage KOA and TCM-defined Liver-Kidney Deficiency syndrome. Methods: This is a prospective, single-center, randomized, single-blind, four-arm, parallel-group controlled clinical trial. A total of 140 patients with KOA meeting both the Kellgren-Lawrence grade I–II radiographic criteria and the TCM diagnostic criteria for Liver-Kidney Deficiency syndrome (as outlined in the Guiding Principles for Clinical Research on New Chinese Medicines) will be enrolled. Participants will be randomly assigned in a 1:1:1:1 ratio to one of four groups:Control group (usual care), Fumigation group, BFRT group, or Combined intervention group. The intervention period will last 8 weeks, with follow-up assessments conducted at week 12. The primary outcome is the total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include: pain intensity measured by the Visual Analogue Scale (VAS), TCM syndrome severity score, the 36-Item Short Form Health Survey (SF-36), knee extensor muscle strength, and the Clinical Global Impression of Change (CGI-C). All outcomes will be assessed by blinded evaluators at baseline (week 0) and at weeks 4, 8, and 12. Results: Participant recruitment is scheduled to begin in January 2026, with enrollment and interventions expected to be completed by June 2027. Data collection will conclude by October 2027, and primary statistical analysis and manuscript preparation are anticipated in early 2028. Conclusions: Through a rigorously designed randomized controlled trial, this study will investigate the feasibility, efficacy, and safety of an integrative intervention combining TCM external therapy (herbal fumigation) with modern low-load resistance training (BFRT) in patients with early-stage KOA and Liver-Kidney Deficiency. The findings are expected to inform clinical practice and support further research into non-pharmacological, multimodal strategies for managing early KOA within an integrative medicine framework. Clinical Trial: International Traditional Medicine Clinical Trial Registry (ChiCTR), Registration Number: ChiCTR2200066875. Date Registered: December 15, 2025. https://itmctr.ccebtcm.org.cn/

  • iCAN: A chatbot-assisted mobile aftercare app for adolescents and young adults with depression – Protocol for a multicenter mixed-methods randomized controlled trial

    Date Submitted: Feb 10, 2026
    Open Peer Review Period: Feb 11, 2026 - Apr 8, 2026

    Background: Depression is prevalent among adolescents and young adults and often requires aftercare following inpatient treatment. Although effective outpatient aftercare exists, many patients face difficulties in maintaining treatment gains and remain without professional support after being discharged. Digital mental health interventions hold promise for bridging this care gap; however, evidence of their effectiveness is limited. Objective: This protocol outlines a study evaluating the effectiveness, cost-effectiveness, and implementation of a chatbot-assisted smartphone intervention (iCAN) designed to support youth following inpatient treatment for depression. Methods: This is a prospective, two-armed, mixed-methods randomized controlled trial. The targeted sample size is n = 368 patients aged 13–25 years with depressive disorders who were receiving inpatient treatment and, additionally, n = 18 healthcare providers. Participants in the intervention group received care as usual plus an e-coach-guided intervention for 90 days, whereas the control group received care as usual only. Assessments were conducted at baseline and 6 weeks, 3 months, and 6 months after randomization. The primary outcome is clinician-rated severity of depression symptoms. Secondary outcomes include remission rates, general psychopathology, quality of life, uptake of aftercare services, cost-effectiveness, mechanisms of action, as well as acceptability, and usability. Outcome evaluation will use linear mixed models based on the intention-to-treat principle, and process evaluation will be conducted via content analysis. Results: We enrolled n = 228 patients from 31 hospitals across Germany between November 2023 and December 2024. Data collection (6 months follow-up) was completed June 2025. Data analysis is currently in progress, with the first results expected to be published by the end of 2026. Conclusions: This study will provide evidence for the effectiveness and cost-effectiveness of a guided digital mental health intervention for post-discharge aftercare of youth treated for depression in an inpatient setting. It will offer insights into the implementation of the intervention in routine care. If proven effective, iCAN may serve as a blueprint for remote aftercare for young people with depression. Clinical Trial: This trial is registered in the German register for clinical trials (DRKS-ID: DRKS00032966)

  • Background: Lumbar disc herniation (LDH) is one of the leading causes of low back and leg pain. Although percutaneous endoscopic lumbar discectomy (PELD) is a useful procedure with a minimally invasive surgical procedure, there are patients with persistent pain and functional impairment. Traditional Chinese Medicine (TCM) has a treatment called Tuina, which was found to be effective in conservative management of LDH. The high-quality evidence of its combined use during the perioperative period of PELD is not available. Objective: The main aim of the trial will be to determine the clinical effectiveness and safety of the Zheng’s "Gu cuo feng, jin chu cao"manipulative therapy when used as the adjunctive to percutaneous endoscopic lumbar discectomy (PELD) of single-level LDH. Methods: The study is a protocol of a randomized controlled superiority trial in a multicenter parallel-group trial to be carried out in 4 Chinese hospitals. There will be 220 eligible patients with single-level LDH randomly assigned by means of 1:1 assignment to the experimental group (it will receive Zheng’s Tuina manipulative therapy before and after the PELD) and to the control group (it will receive PELD only). The main outcome is change in the baseline scores of the Oswestry Disability Index (ODI) score in 3 months after surgery. Visual Analogue Scale (VAS) of the pain, SF-12 health survey, and modified Macnab criteria are classed as the secondary outcomes. The outcome assessors and data analysts will not know the group allocation. Results: - Conclusions: The trial will be rigorous in offering evidence concerning the integration of Chinese and Western medicine in the treatment of LDH. This combination methodology might help in achieving functional recovery, better pain management, and creating a new standard of perioperative rehabilitation among this patient group in case it was proven effective. Clinical Trial: ITMCTR2025001254. Registered on International Traditional Medicine Clinical Trial Registry, 2025.

  • Background: The cognitive paradigm in medical education is undergoing a transition from traditional knowledge transmission to learner-centered knowledge construction. In China, this shift is aligned with the Outline of the Plan for the Construction of China into an Education Powerhouse (2024-2035), which mandates high-quality, intrinsic development in nursing curricula. While Constructivist Learning Theory (CLT)–based teaching methods (eg, PBL, CBL, and situational simulation) have been widely explored across Chinese nursing institutions, the evidentiary base remains geographically fragmented and methodologically heterogeneous. A systematic synthesis is required to inform national evidence-based educational reforms. Objective: This protocol describes a systematic review and meta-analysis designed to evaluate the effectiveness of CLT-based teaching methods versus traditional lecture-based models on Chinese nursing students’ theoretical knowledge, practical skills, self-directed learning ability, and critical thinking disposition. Methods: A comprehensive systematic search will be conducted across nine electronic databases: PubMed, Web of Science, the Cochrane Library, Embase, CINAHL, China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Database (Chinese Scientific and Technological Journal Database), and China Biology Medicine (CBM). The search period spans from database inception to September 27, 2025, with an update scheduled for May 31, 2026. Randomized controlled trials and quasi-experimental studies involving Chinese nursing students will be included. Two independent reviewers will screen titles and abstracts, perform full-text retrieval, and extract data using standardized forms. Risk of bias will be assessed using the Cochrane Risk of Bias tool 2 (RoB 2) for randomized trials and the Joanna Briggs Institute (JBI) critical appraisal tools for quasi-experimental studies. Meta-analysis will be performed using Review Manager (RevMan) 5.4 and Stata 18.0, employing random-effects models and subgroup analyses based on educational level (eg, vocational vs. undergraduate) and intervention type. Results: This protocol was finalized in February 2026. A preliminary systematic search was conducted on September 27, 2025, identifying 990 records prior to deduplication. As of February 6, 2026, deduplication has been completed and title/abstract screening is underway. Full-text retrieval is expected to be completed by June 2026, and data extraction and risk-of-bias assessment are expected to be completed by July 2026. The final results manuscript is targeted for submission in September 2026. Conclusions: This review will provide a robust evidentiary foundation for the strategic deployment of constructivist methodologies in Chinese nursing education, specifically addressing the needs of vocational and undergraduate programs in the era of digital transformation. Clinical Trial: PROSPERO CRD420251159499

  • Influence of a Multicomponent Supervised Exercise Program in Frail and Pre-Frail Community-Dwelling Older Adults: Study Protocol for a Randomized Controlled Trial

    Date Submitted: Feb 8, 2026
    Open Peer Review Period: Feb 10, 2026 - Apr 7, 2026

    Background: Multicomponent supervised exercise programs have demonstrated efficacy in improving physical performance and mitigating frailty in older adults, especially when adapted to functional capacity. However, evidence remains limited regarding their effects in community-dwelling frail and pre-frail individuals in Brazil. Objective: This protocol study aimed to evaluate the effects of a 12-week multicomponent supervised exercise program on frailty status, functional capacity, clinical-functional vulnerability, and fall risk in frail and pre-frail community-dwelling older people. Methods: This protocol describes the methodology of a single-blind, randomized controlled trial, which will assess a total of 60 participants aged 60 years and older that will be recruited from a community senior center in Rio Verde, Brazil, and randomly allocated to an intervention group (multicomponent supervised exercise based on the VIVIFRAIL model) or to a control group (educational workshops on healthy aging). The primary outcomes will be functional capacity (6-Minute Walk Test) and fall risk (Timed Up and Go Test), but covariates will include clinical-functional vulnerability (CFVI-20), cognitive status (MMSE), depressive symptoms (GDS-15), physical activity level (IPAQ), muscular mass (calf circumference), and fear of falling (FES-I). Assessments will be conducted at baseline and post-intervention. Results: This protocol will provide evidence regarding the effectiveness of a supervised multicomponent exercise program for improving frailty status, functional outcomes, and fall-related risk in a vulnerable population of Brazilian elderly. Conclusions: If effective, the intervention may offer a scalable, low-cost, and culturally appropriate strategy to promote healthy aging and reduce physical decline in community settings vulnerable subgroups. Clinical Trial: Brazilian Registry of Clinical Trials RBR-9zvtc5b; https://ensaiosclinicos.gov.br/rg/RBR-9zvtc5b

  • Association between Maternal ABO Blood Group and Preeclampsia: Protocol for an Updated Systematic Review and Meta-analysis

    Date Submitted: Feb 8, 2026
    Open Peer Review Period: Feb 10, 2026 - Apr 7, 2026

    Background: Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality worldwide. ABO blood group phenotypes have been associated with thrombosis, endothelial dysfunction, and inflammation, which are key mechanisms implicated in the pathogenesis of preeclampsia. Observational studies have reported inconsistent associations between maternal ABO blood group and preeclampsia risk. Since the last comprehensive meta-analysis in 2021, several new studies have been published. Therefore, an updated systematic review and meta-analysis is warranted to provide robust and up-to-date evidence on this association. Objective: This study aims to systematically review and quantitatively synthesize the available evidence on the association between maternal ABO blood group and the risk of preeclampsia. Methods: This protocol follows the PRISMA-P 2015 guidelines and has been prospectively registered in the Open Science Framework (OSF) under the identifier 10.17605/OSF.IO/E3KTG (https://osf.io/zm4nf). Observational studies (case-control, cohort, and cross-sectional) reporting maternal ABO blood group and preeclampsia outcomes will be included. A systematic search will be conducted in PubMed/Medline, Embase, Scopus, Web of Science, and the Cochrane Library for studies published from January 2000 to October 31, 2025. Grey literature sources including Google Scholar, ProQuest Dissertations, and conference abstracts will also be searched. Two independent reviewers will perform study selection, data extraction, and risk of bias assessment using the Newcastle-Ottawa Scale. A random-effects meta-analysis will be performed to pool odds ratios for each blood group, and heterogeneity will be assessed using Cochran’s Q and I² statistics. Subgroup and sensitivity analyses will be conducted, and publication bias will be evaluated using funnel plots, Egger’s test, and trim-and-fill method. The certainty of evidence will be assessed using the GRADE approach. Results: The literature search, study selection, and data extraction are expected to be completed by December 2025. We anticipate identifying and synthesizing data from recently published observational studies in addition to previously included studies, thereby increasing the overall sample size and statistical power compared with prior meta-analyses. The meta-analysis will provide pooled effect estimates for each ABO blood group in relation to preeclampsia risk and assess the robustness and certainty of the evidence. Conclusions: This updated systematic review and meta-analysis will provide comprehensive and current evidence regarding the association between maternal ABO blood group and preeclampsia risk. The findings may clarify inconsistencies in the literature and determine whether ABO blood group could serve as a potential risk marker for preeclampsia, thereby informing future research and clinical decision-making. Clinical Trial: OSF 10.17605/OSF.IO/E3KTG

  • A Co-Design Protocol Embedded in a Rapid Learning Health System to Improve Digital Measurement-Based Care within Emerging Adult Mental Health Care Pathways

    Date Submitted: Feb 6, 2026
    Open Peer Review Period: Feb 9, 2026 - Apr 6, 2026

    Background: Emerging adults (EAs), typically ranging from late adolescence into mid- to late-twenties, navigate a transitional period marked by rapid developmental, social, and psychological change. Despite heightened vulnerability to mental health concerns during this stage, service systems are often fragmented, with gaps between adolescent and adult care streams that leave many EAs without developmentally appropriate support. In response, developing approaches such as transdiagnostic stratification, which structures care around shared symptom processes and informs treatment intensity, and digital measurement-based care (dMBC), based on routine patient-reported outcome measures (PROMs), have gained traction but remain challenging to implement consistently. This reinforces the need for Rapid Learning Health System (RLHS) approaches that leverage continuous data and feedback for ongoing improvement, as well as co-design methods that meaningfully integrate EA perspectives into service improvement. Objective: This research protocol outlines a co-design study situated within an RLHS to develop practical strategies and resources to support the sustained implementation of dMBC within EA mental health services. Anticipated outputs include clinician-facing workflow supports, guidance for using client-reported data in clinical decision-making, EA-oriented materials to support engagement with measures, and implementation planning resources to support uptake across the care pathway. Each co-designed output will be developed to function across core stages of care, including intake, treatment decision-making, therapy, and discharge. Methods: A concurrent multi-methods design will be employed, integrating quantitative and qualitative approaches within a dual methodological framework combining User-Centered Design with Participatory Design to structure the co-design process and guide the development of implementation outputs. The process will center the perspectives of EAs accessing services and clinical staff to actively collaborate in informing the development and refinement of study outputs. Results: As the study is underway, findings will be reported upon study completion. Conclusions: This study is expected to demonstrate the value of integrating co-design within an RLHS to advance more responsive, contextually grounded dMBC implementation in EA mental health care, while also contributing insights that can strengthen future co-design efforts with this population.

  • Background: African American women are among the least physically active demographic groups in the United States and face disproportionate burdens of chronic disease that are preventable through regular physical activity. Researchers are increasingly using mixed methods to better understand the behaviors, beliefs, and contextual factors that shape physical activity in this population. Objective: To identify, examine, and describe the key characteristics of mixed methods study designs used in research on the physical activity practices of African American women published within the past ten years, compare methodological approaches, identify gaps, and offer recommendations for future inquiry. Methods: Following the Joanna Briggs Institute (JBI) methodology for scoping reviews, we will implement a three-step search strategy across seven databases (Academic Search Ultimate, Agricultural & Environmental Science Database, APA PsycInfo, CINAHL Ultimate, PubMed, SocINDEX, and SPORTDiscus). Eligible studies are peer-reviewed, single mixed-methods investigations conducted in the United States that include adults (≥18 years) who identify as non-Hispanic African American/Black women, or samples with ≥50% African American women, with results reported by social classification. Two reviewers will independently screen and extract data with adjudication by a third reviewer as needed. We will chart designs (e.g., convergent, explanatory sequential, exploratory sequential), quantitative and qualitative methods, integration approaches (e.g., merging, connecting, embedding), and evidence of mixing (e.g., transformation, comparison, synthesis). Results will be summarized narratively, tabulated, and visualized in a frequency flow diagram. The process will be documented using a PRISMA 2020 flow diagram. Results: As this is a protocol, no results are reported. The initial search was piloted on February 1, 2026. We anticipate completing study selection, data charting, and synthesis by May 2026, with the completed review submitted in July 2026. Conclusions: Mapping the application of mixed methods in studies of African American women’s physical activity will reveal methodological patterns and gaps, guiding stronger, equity-centered research designs and reporting. Clinical Trial: OSF Registration: https://doi.org/10.17605/OSF.IO/NA9ME

  • Background: Cardiac myxomas (CMs) are the most common benign primary cardiac tumours, most frequently originating from the left atrium, and less commonly from the right atrium. Despite being histologically benign, CMs can cause serious thromboembolic complications including stroke, acute coronary syndrome, limb ischemia, and visceral infarction. While previous studies have explored risk factors for thromboembolism, literature comprehensively synthesising the anatomical distribution, clinical patterns, and management of CMs remains limited. Objective: We intend to summarise the published evidence on the frequency, anatomical distribution, clinical presentations, and management implications of thromboembolic events associated with CMs. Methods: A systematic review will be conducted in accordance with PRISMA-P guidelines and registered on PROSPERO. Medline, Embase, and PubMed will be searched for studies reporting thromboembolic complications in patients with histologically or radiologically confirmed CMs. Eligible study designs include case reports, case series, cohort studies, and registries. Two reviewers will independently screen studies and extract data on patient demographics, tumour characteristics, embolic events (type, site, clinical presentation), diagnostics, management, and outcomes. Discrepancies will be resolved through discussion or third-party adjudication. Risk of bias will be assessed using Joanna Briggs Institute tools. Results: The review will summarise reported frequencies and anatomical distribution of embolic events, clinical presentations, associations with tumour characteristics, and management strategies. Case reports will be tabulated individually, while cohort and series data will be aggregated descriptively with quantitative summaries presented where feasible. Conclusions: This review aims to provide a comprehensive synthesis of thromboembolic complications associated with CMs, highlighting patterns, management strategies, and gaps in the current literature. Findings aim to improve clinical recognition, inform clinical management, and guide future research. Clinical Trial: This study is a systematic review and not a clinical trial. The review protocol was prospectively registered with PROSPERO (CRD420261299634).