To assess the level of alarm fatigue among intensive care unit (ICU), cardiac care unit (CCU) and emergency room (ER) nurses, identify associated demographic and occupational factors, determine the most frequent sources of alarms and evaluate nurses’ psychological reactions to alarms.

A cross-sectional, descriptive–analytical study.

ICUs, CCUs and ERs of six public teaching hospitals affiliated with Tehran and Kashan Universities of Medical Sciences in Iran.

Using a multistage stratified random sampling method, 285 nurses were approached, of whom 260 completed and returned the questionnaires (response rate: 91%). Participants were registered nurses with at least a bachelor’s degree or higher and 3 months of experience in ICUs, CCUs or ERs.

The primary outcome was the level of alarm fatigue measured using the validated Nurses’ Alarm Fatigue Questionnaire. Secondary outcomes included factors associated with alarm fatigue and nurses’ reported psychological responses to frequent alarms.

The mean score of alarm fatigue was 26.4±7.9, indicating a moderate level. After adjusting for confounders and hospital-level clustering using multivariable mixed-effects regression, higher monthly income was significantly associated with lower alarm fatigue (β=–0.15, p=0.03), and nurses working rotational shifts reported significantly higher fatigue compared with those with fixed shifts (β=0.18, p=0.02). Other demographic and occupational factors were not significant. Reported psychological reactions to alarms included indifference (14%), irritability (18%) and anxiety/stress (15%).

ICU, CCU and ER nurses experience a moderate level of alarm fatigue, with income and shift type as independent associated factors. The association between income and alarm fatigue may reflect the role of financial stress as an additional job demand that compounds the burden of frequent alarms, particularly in contexts where low base salaries lead nurses to rely on overtime and multiple shifts. These findings underscore the need for targeted managerial and educational interventions, including shift schedule optimisation and attention to workload-related stressors, alongside alarm prioritisation strategies. Due to the cross-sectional design, causal inferences cannot be drawn.

To develop and user-test a patient decision aid for people diagnosed with degenerative cervical myelopathy and who are considering surgery.

Mixed-methods study describing the development of a patient decision aid.

A draft decision aid was developed by a multidisciplinary steering group (including study authors with degenerative cervical myelopathy, health professionals and researchers) informed by the best available evidence, authorship consensus and existing patient decision aids.

Patient-participants and health professional-participants who manage people with degenerative cervical myelopathy were recruited through social media and the steering group’s research and practice network. Quantitative questionnaires were used to gather baseline data, descriptive feedback, refine the decision aid and assess its acceptability. Qualitative semi-structured interviews were conducted online to gather feedback on the decision aid and were analysed using reflexive thematic analysis.

We conducted 32 interviews: 19 patient-participants and 13 health professional-participants who manage people with degenerative cervical myelopathy (neurosurgeons, neurologists, physiotherapists, orthopaedic surgeons, general practitioners, rehabilitation and pain specialists and consultant occupational physicians and chiropractors). Participants were from 10 countries (Australia, Canada, Cyprus, Germany, Ireland, New Zealand, Sweden, Switzerland, United Kingdom and USA). Most participants rated the decision aid’s acceptability as good-to-excellent and agreed with most aspects of the decision aid (eg, defining degenerative cervical myelopathy, management recommendations, potential benefits and harms, questions to consider asking a health professional).

Our patient decision aid was rated as an acceptable tool by both health professional-participants who treat degenerative cervical myelopathy and patient-participants with lived experience of degenerative cervical myelopathy. This decision aid can be used by clinicians and people with degenerative cervical myelopathy to help with shared decision making following a diagnosis of degenerative cervical myelopathy. A study testing the potential benefits of this decision aid in a clinical setting is recommended.

Language-concordant care, or healthcare in one’s preferred language, is important both for health equity and for improving health outcomes. Linguistic minorities, like Francophones in Ontario, Canada, are at risk of poorer clinical outcomes if they receive non-language-concordant primary care. However, common ratio-based access measures can provide misleading views of minorities’ actual access levels. This cross-sectional geospatial study demonstrates a new way to measure primary care access using average travel time to the nearest five English- and French-speaking family physicians. We also introduce the concept of primary care access fragility, where a region’s primary care access may depend on one or a few local family physicians. Our research question is: are there differences in travel burden and access fragility for census subdivisions (CSDs) across language (English/French), rurality (urban/rural) and region (north/south) in the province of Ontario, Canada?

We conducted a cross-sectional geospatial analysis to estimate English-language and French-language primary care travel burdens and access fragility in Ontario, Canada. We used population and boundary data from Statistics Canada’s 2021 census, road-network data from OpenStreetMaps, and family physician practice locations and language abilities from the College of Physicians and Surgeons of Ontario. We measured travel burden using Valhalla, an open-source road-network analysis platform.

We conducted our analysis for Ontario, Canada’s 577 CSDs, which correspond roughly to municipalities and with populations ranging from 5 inhabitants in Rainy Lake 17B to a high of 2 794 356 in Toronto.

Using public data from January 2026, we identified 15 762 family physicians practising in Ontario, of whom 11.0% reported speaking French. Patient data were obtained from the most recent 2021 census.

Our first primary outcome measures were CSD-level mean travel time to the nearest five English-speaking family physicians, and CSD-level mean travel time to the nearest five French-speaking family physicians, which we compared to explore regional inequities in travel burden. Our secondary outcome measures were based on a novel notion of the travel burden component of ‘primary care access fragility’. This metric indicates how dependent a region’s access is on a small number of local physicians and is defined as the difference between the CSD-level mean travel time to the nearest one physician and to the nearest five physicians. As the difference in travel times grows, so too does access fragility.

Median differences in French-language and English-language travel burdens were strongly significant across rurality, regions and overall (median difference 13.4 min, p

Compared with the general public, Ontario’s French-speakers face higher travel burdens to language-concordant family physicians and higher access fragility, especially in rural and northern regions. Our results are of interest to policymakers and health-system planners, and our methods are applicable to other populations and regions.

To develop and evaluate an explainable machine learning framework enhanced with synthetic data generation to predict unplanned 30-day hospital readmissions among patients with chronic obstructive pulmonary disease (COPD), heart failure (HF) and type 2 diabetes mellitus (T2DM), and to identify key clinical and social predictors of readmission.

A retrospective cohort study using electronic health record data incorporating both structured variables and information extracted from unstructured clinical notes. Synthetic data were generated using advanced resampling and deep learning-based techniques to address outcome imbalance and improve model training.

Intensive care unit and general ward admissions at a single tertiary academic medical centre included in the MIMIC-IV (Medical Information Mart for Intensive Care IV) database.

Adult patients (≥18 years) were admitted with a primary diagnosis of COPD (n=14 050), HF (n=7097) or T2DM (n=12 735) between 2008 and 2019, with complete 30-day follow-up and no in-hospital mortality during the index admission.

The primary outcome was unplanned all-cause hospital readmission within 30-days of discharge. Predictors were drawn from six domains, including demographics, comorbidities, clinical acuity, therapies, behavioural factors and care continuity. Predictive performance was evaluated using multiple machine learning methods and fivefold cross-validation, with model interpretability assessed using established goal and local explanation approaches.

Ensemble-based machine learning models demonstrated the strongest predictive performance across all three disease cohorts. Key predictors of readmission included higher illness severity, greater comorbidity burden, medication non-adherence, gaps in preventive care and limited social support. Models incorporating synthetic data augmentation showed improved discrimination compared with models trained on original data alone.

An explainable synthetic-data driven framework incorporating clinical, behavioural and social data can support prediction of 30-day readmissions among patients with common chronic conditions using routinely available electronic health record data.

Sub-Saharan Africa (SSA) continues to be the hub of the global HIV/AIDS pandemic, globally. Despite several attempts to meet their HIV prevention needs, men continue to have high rates of HIV infection. Pre-exposure prophylaxis (PrEP) is an effective treatment that, when taken as prescribed, can be very efficient in preventing and reducing the risk of HIV acquisition. HIV self-testing (HIVST) has been demonstrated to be acceptable among men in SSA. As such, this review aims to explore the existing literature on the integration of PrEP dispensing with HIVST among men in SSA.

We will systematically search bibliometric databases, including PubMed/MEDLINE, Embase, Scopus, the Cumulative Index to Nursing and Allied Health Literature Plus, Sociological Abstracts, ProQuest Dissertations and Theses global. Our review will be guided by the Arskey and O’Malley framework and Levac et al. The review results will be reported using the preferred reporting items for systematic reviews and meta-analysis: extension for scoping reviews guidelines. To assess the methodological quality of the included articles, the mixed methods appraisal tool version 2018 will be used. We will use NVivo software (V.11) to synthesise data from the included studies using a thematic approach.

Ethical approval is not required, as this review uses publicly available data. Findings will be disseminated through peer-reviewed publication, conference presentations and engagement with key stakeholders in HIV prevention and treatment across SSA.

Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

RBR-3dcrj98.

To synthesise the prevalence and patterns of dementia-relevant structural brain MRI abnormalities in adults with suspected or confirmed dementia in low- and middle-income countries (LMICs), and to summarise MRI protocols and the incremental diagnostic contribution of MRI beyond cognitive screening.

Systematic review and meta-analysis.

PubMed, EMBASE, Web of Science and PsycINFO (January 1990–27 January 2025), plus reference list screening and targeted manual searches.

Observational or diagnostic-accuracy studies from World Bank-defined LMICs including adults (≥50 years) with suspected or confirmed dementia who underwent brain MRI as part of diagnostic evaluation.

Two reviewers independently screened, extracted data and assessed risk of bias using ROBINS-I. Random-effects models pooled prevalence of dementia-relevant MRI abnormalities; diagnostic-accuracy outcomes were synthesised narratively due to heterogeneous reference standards and incomplete reporting.

39 LMIC studies were included; 23 studies (2513 participants) contributed to the meta-analysis. Dementia-relevant MRI abnormalities (defined as ≥1 clinically relevant structural abnormality per study definition) were present in 1248/2513 participants. The pooled prevalence of dementia-relevant MRI abnormalities was 58% (95% CI 43% to 72%), with substantial heterogeneity (I²=95%) and a wide prediction interval (8–96%), indicating marked between-study variability; this estimate should be interpreted as a descriptive summary of study-level proportions rather than a precise population parameter.

Brain MRI frequently demonstrates dementia-relevant pathology in LMIC clinical cohorts, usually with mixed neurodegenerative-vascular patterns. Structured visual ratings may add aetiologic specificity beyond cognitive screening, but pooled estimates should be interpreted as summaries of heterogeneous study-level findings rather than precise population parameters, given high heterogeneity and risk of bias.

CRD42024510241.

Suicide is a major public health concern among youth in Canada and worldwide. The most rapid increases in suicidal ideation, self-harm, and suicide attempts have been observed among adolescent girls, particularly since the COVID-19 pandemic. Recent studies report disproportionately high rates of emergency department visits and hospitalisations for suicide-related concerns among adolescent girls. Despite these concerning trends, limited evidence exists on the life trajectories, needs, and service pathways of adolescent girls who attempt suicide. This protocol describes a qualitative suicide audit focused on adolescent girls aged 12–17 who were hospitalised following a suicide attempt in two regions of the province of Québec, Canada. The aim is to understand developmental trajectories, document services received and identify individual, relational and systemic factors influencing these trajectories to generate recommendations that inform suicide prevention.

Using a narrative qualitative design and a community-based research approach, data will be collected from semi-structured interviews with adolescents and parents, parent questionnaires and hospital health records. These data will be integrated to develop anonymised case vignettes. A multidisciplinary panel, including clinicians, health system stakeholders, community partners and individuals with lived experience, will review each case to identify gaps and strengths in care and generate case-level and cross-case recommendations for clinical practice, health policy and professional training.

Ethics approval was obtained from the research ethics committee (REC) of the Centre intégré de santé et de services sociaux de Chaudière-Appalaches, which serves as the reviewing REC, with administrative reviews underway at two other health authorities. Findings will be disseminated through peer-reviewed publications, conference presentations and collaborative knowledge-mobilisation activities with clinical and community partners, including practice-oriented tools and accessible materials for adolescents and parents.

Early screening of non-alcoholic fatty liver disease (NAFLD) is critical for early diagnosis and management. The disease was renamed and its diagnostic criteria revised as metabolic-associated FLD (MAFLD) in 2020 and further updated to metabolic dysfunction-associated steatotic liver disease (MASLD) in 2023. This study evaluated the predictive performance and clinical feasibility of non-invasive diagnostic indicators across the NAFLD, MAFLD and MASLD diagnostic criteria.

Cross-sectional study.

Health Management Centre in China.

A total of 5810 participants aged ≥18 years were enrolled. Individuals with missing laboratory data, imaging results or self-reported information were excluded.

Disease-specific indicators included Fatty Liver Index (FLI), Hepatic Steatosis Index and Zhejiang University index (ZJU). Non-disease-specific indicators included lipid accumulation product (LAP), Visceral Adiposity Index and the Triglyceride and Glucose Index. Subgroup analysis was performed by gender and Body Mass Index (BMI).

The area under the receiver operating characteristic curve (AUROC) for all six non-invasive indicators exceeded 0.7. FLI showed the optimal predictive performance across the three criteria (NAFLD-AUROC: 0.802, MAFLD-AUROC: 0.847 and MASLD-AUROC: 0.811), with comparable performance observed for ZJU (0.797, 0.838 and 0.809, respectively). Pairwise z-tests demonstrated a significant difference between FLI and ZJU for MAFLD (p0.05). Subgroup analyses revealed that ZJU performed better in males (NAFLD-AUROC: 0.790, MAFLD-AUROC: 0.839 and MASLD-AUROC: 0.803), while FLI was superior in females (NAFLD-AUROC: 0.832, MAFLD-AUROC: 0.838 and MASLD-AUROC: 0.838) and in participants who were overweight (NAFLD-AUROC: 0.709, MAFLD-AUROC: 0.765 and MASLD-AUROC: 0.709). LAP exhibited the highest predictive efficacy in the normal BMI subgroup (NAFLD-AUROC: 0.758, MAFLD-AUROC: 0.804 and MASLD-AUROC: 0.796).

FLI exhibited the highest predictive efficacy across all diagnostic criteria, and ZJU showed comparable performance. Considering diagnostic accuracy and clinical practicality, ZJU is recommended as a favourable, non-invasive tool for population-based screening in the Chinese population.

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

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

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

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

Clinical documentation is a significant driver of burnout among physicians. Ambient artificial intelligence (AI) scribes, which leverage generative large language models to automate the creation of clinical notes from patient–physician conversations, are rapidly emerging as a potential solution. While these tools promise to enhance efficiency and reduce administrative tasks, concerns about the quality, accuracy and potential biases persist. There is now a need for a systematic synthesis of evidence to evaluate the impact of these technologies in clinical practice. To assess the effects of ambient AI scribes on physicians’ clinical documentation, the specific objectives are to: (1) evaluate the effectiveness of these tools on documentation, including accuracy and completeness; (2) synthesise evidence on the impact on physician efficiency after adoption, including time spent on documentation and (3) examine physicians’ satisfaction with these tools, including physicians’ perceived burden.

A systematic review of quantitative or mixed-method studies as well as preprints will be conducted. We will perform a comprehensive search of four electronic databases (PubMed, IEEE Xplore, APA PsycInfo and Web of Science, along with medRix and ClinicalTrials.gov for preprints) for empirical studies published between January 2023 and March 2026. The review will synthesise studies comparing physicians’ use of ambient AI scribes with traditional documentation approaches. Given the anticipated heterogeneity of the studies, a narrative synthesis will be employed to summarise the findings. Where common quantitative outcomes exist, effect sizes will be calculated using Hedges’ g, mean differences or risk ratios/odds ratios as appropriate. The overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.

As no patient data are involved in the data collection, no ethical approval is acquired. Results will be disseminated in a peer-reviewed, open-access journal, and presented at relevant academic conferences.

CRD420251149086.

Inappropriate complementary feeding contributes to child undernutrition, even in food-secure areas. This paradox highlights the need to look beyond food availability and examine the household-level mechanisms that shape everyday feeding decisions in the farming and food-secure settings. The objective of this study was to explore the household dynamics of maternal caregiving and agricultural labour in complementary feeding practices in rural farming communities in Geita.

Phenomenology study design was employed to explore the lived experiences and perceptions of mothers regarding complementary feeding practices.

Rural farming communities in Geita Region, Tanzania.

Mothers of children aged 6–23 months were purposively selected to participate in seven in-depth interviews and two focus group discussions.

In these farming communities, four household-level factors were found to influence complementary feeding practices: maternal responsibility and farming obligations, carrying children and porridge to the farms, limited paternal involvement, fatigue due to prolonged farm work, reliance on elder siblings for childcare and fear of judgement or sanctions for late arrival at the farm. Farming emerged as a cross-cutting theme that intersected all these sub-themes.

Mothers described complementary feeding practices as closely linked to household division of labour, caregiving arrangements and the demands of farming activities that shaped daily routines. These findings suggest the need for context-sensitive strategies that consider intra-household roles and the time constraints associated with subsistence farming.

Men, particularly those belonging to gender minority groups, often experience poorer physical health outcomes. This study examined global health and quality of life (QoL) across diverse male gender subgroups in Switzerland. While emphasising male gender diversity, we aimed to identify key sociodemographic risk factors associated with reduced global health and QoL.

We analysed a subset of the Swiss Health Survey 2022, a cross-sectional nationally representative health-related dataset from the general Swiss population. Our sample included individuals falling into one of the three groups: cisgender men, transgender men (assigned female at birth with male gender identity) and men with ‘other’ gender identities (assigned male at birth but identifying as non-binary or non-specified gender identity). Global health and QoL were assessed using the Minimum European Health Module (MEHM) and the global QoL item of the WHOQOL-Bref. Four binary logistic regression models examined the association between male gender identities, sociodemographic data and MEHM and QoL outcomes.

Our study comprised 3 505 801 male cases after weighting. Of these, 12.9% reported fair to very poor health. Key risk factors included being unemployed, migration background and being a transgender man. The strongest protective factor was higher education. Chronic conditions were reported by 33.3% men, with unemployment again being the most relevant risk factor. Identifying as a man with ‘other’ gender identities emerged as a protective factor. Regarding QoL, 8% stated impaired QoL, while the male gender identity ‘other’ was the strongest risk factor and tertiary school education the most relevant protective factor.

Risk and protective factors vary across different global health outcomes and QoL in men. These findings highlight the importance of disaggregating male gender categories beyond the binary to better understand the complexity of health disparities. A differentiated, gender-inclusive approach is essential for accurately identifying vulnerable groups and tailoring public health interventions accordingly.

Socioeconomic inequalities in neonatal mortality are observed globally but gaps remain in the evidence from current reviews, specifically: a wider range of socioeconomic indicators at the individual, household and area level than previous reviews, and alternative time frames to define neonatal mortality. Thus, a comprehensive updated review of the literature is required, focusing on multiple measures of socioeconomic status and alternative time frames, to assess the relationship between maternal socioeconomic status and neonatal mortality in high-income countries.

Three different search approaches will be used: electronic searching of three databases, grey literature searching and reference list checking. First, the three databases Medline, Scopus and Web of Science will be searched using relevant synonyms and adapted terms from medical subject heading terms (MeSH) in Medline for maternal socioeconomic status and neonatal mortality identified from previous systematic reviews on inequalities in adverse pregnancy outcomes. Second, grey literature will be searched by entering the relevant terms into Google. Title, abstract and full text screening will be conducted by the review team against the inclusion and exclusion criteria, with at least 10% checked by a second reviewer to assess for any bias and errors. We will also conduct the kappa statistic for inter-rater reliability. Third, the reference lists of included studies will be reviewed for any additional studies that meet the criteria. Data will be extracted using a data extraction form and extracted studies will be assessed using the Liverpool Quality Assessment Tool. A narrative synthesis will be conducted and, where appropriate, meta-analysis will be performed. If the data allow, subgroup analysis by neonatal care population and specific gestational ages will be performed.

Ethical approval is not required as all studies in this systematic review will be publicly available. The findings of this review will be presented at conferences and disseminated in peer-reviewed publications.

CRD42022315407.

Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder, often accompanied by comorbidities like type 2 diabetes mellitus (T2DM). These conditions have a significant impact on patients’ sleep quality and metabolic health. Current treatments for KOA primarily focus on symptom management, while innovative approaches targeting interconnected health outcomes remain underexplored. The lumbar knee recovery device, a non-invasive device patented in Iran, offers potential benefits by enhancing lumbar-knee synchronisation, improving blood circulation and optimising cellular metabolism. This randomised controlled trial (RCT) aims to evaluate the device’s effectiveness in improving sleep quality and regulating blood glucose levels in diabetic patients with KOA.

This RCT aims to evaluate the impact of using the lumbar knee recovery device (Kamarasa) on sleep quality, blood glucose levels, HbA1c (blood glucose control level over the past 90 days) and body mass index (BMI) in patients with T2DM and grade 1–3 KOA. The study will be conducted at the Orthopedic Clinic of Imam Khomeini Hospital, Tehran, and the Health and Wellness Clinic. Eligible participants will be randomly allocated into two groups: the intervention group (receiving 10 supervised sessions using the Recovery device over 3 months) and the control group (receiving standard KOA and diabetes care). A total of 37 participants will be included in each group. The primary outcome, sleep quality, will be assessed using the Pittsburgh Sleep Quality Index at baseline and 3 months post intervention. Secondary outcomes will include random blood glucose levels, which will be measured at 10 intervals during the study; BMI, measured at the start and end of the study and HbA1c, assessed at both baseline and post intervention. The Western Ontario and McMaster Universities Arthritis Index will be used to assess pain, stiffness and physical function, also at both baseline and 3 months. Appropriate statistical tests, including two-sample t-tests, ² tests, analysis of covariance or linear regression, will be performed based on the type of variables using SPSS V.23. Additionally, standardised intervention effect sizes will be calculated for each outcome.

Ethical approval for this study was obtained from the Research Ethics Committee of the School of Nursing and Midwifery at Tehran University of Medical Sciences with reference number (IR.TUMS.FNM.REC.1403.145). Additionally, the study protocol was registered with the IRCT under the identifier IRCT20191027045257N7 on 24 November 2024.

Iranian Registry of Clinical Trials (IRCT20191027045257N7). This clinical trial was registered on 24 November 2024.