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A prospective, open-label, clinical investigation of a single intra-articular polyacrylamide hydrogel injection in participants with knee osteoarthritis: a 5-year extension study

J Orthop Surg Res. 2025 Dec 12. doi: 10.1186/s13018-025-06526-0. Online ahead of print.

ABSTRACT

BACKGROUND: Knee osteoarthritis is a highly prevalent and painful joint disorder with limited long-term treatment options. Intra-articular corticosteroids and hyaluronic acid offer only short-term relief and may have safety concerns. This study aimed to evaluate the long-term effectiveness and safety of a single intra-articular injection of 2.5% polyacrylamide hydrogel in individuals with moderate to severe knee osteoarthritis.

METHODS: This prospective, multicentre, open-label, single-arm clinical study enrolled 49 participants who received a single 6 mL intra-articular injection of 2.5% polyacrylamide hydrogel. After 1 year, 35 participants entered an extension study with yearly assessments up to 5 years post treatment. The primary outcomes for the extension phase included changes from baseline in WOMAC subscales (pain, stiffness, physical function) and Patient Global Assessment (PGA). Safety was evaluated through the incidence of adverse events. Statistical analyses included a mixed model for repeated measures and sensitivity analyses using ANCOVA and baseline observation carried forward.

RESULTS: Of the 49 participants, 27 completed the five-year follow-up. Statistically significant improvements from baseline were observed in WOMAC pain (-14.6; 95% CI: -21.4 to -7.7; p = 0.0002), stiffness (-19.6; 95% CI: -29.9 to -9.3; p = 0.0006), physical function (-12.5; 95% CI: -19.8 to -5.2; p = 0.0015), and PGA (-13.4; 95% CI: -23.3 to -3.5; p = 0.0100). These improvements were sustained throughout the five-year period. A total of 47 adverse events were reported in the extension study, with no serious events attributed to the investigational device. No new adverse device effects were reported in the extension study.

CONCLUSIONS: A single intra-articular injection of 2.5% polyacrylamide hydrogel demonstrated sustained improvements in WOMAC pain, stiffness, physical function, and PGA for up to five years, with a favourable safety profile. These findings support its potential as a long-term treatment option for knee osteoarthritis.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04179552.

PMID:41387884 | DOI:10.1186/s13018-025-06526-0

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Accessibility to antimalarials in Spanish hospitals: analysis of a national survey

Malar J. 2025 Dec 13. doi: 10.1186/s12936-025-05720-z. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the eradication of malaria as a locally transmitted disease in Spain, the incidence of imported cases continues to rise, with Plasmodium falciparum representing the majority of infections. Prompt access to effective antimalarial treatment, particularly artemisinin-based therapies, is crucial to prevent severe outcomes. However, the unguaranteed and irregular availability of these drugs poses a potential threat to patient management. The objective of this study was to evaluate the availability of antimalarial drugs and their procurement times in Spanish hospitals.

METHODS: A nationwide cross-sectional survey was conducted between September 2023 and January 2024. Hospital pharmacists were invited via the Spanish Society of Hospital Pharmacy to report on antimalarial stock levels and procurement times. Data were analysed using descriptive statistics and chi-square tests, stratified by hospital size and the presence of malaria treatment protocols.

RESULTS: A total of 46 hospitals participated. Intravenous artesunate, the first-line treatment for severe malaria, was stocked in 74% of hospitals, but only 60% could acquire it within 24 h on weekdays if not already in stock or more doses were required. Availability was higher and acquisition times were shorter in large hospitals (> 500 beds) and in institutions with established protocols for malaria treatment. Artemisinin-based combinations, such as piperaquine-dihydroartemisinin, and atovaquone-proguanil were more accessible, but weekend acquisition remained limited.

CONCLUSIONS: The study highlights substantial variability and critical delays in antimalarial drug availability across Spanish hospitals. Enhancing access requires national stockpiling strategies, broader implementation of standardized treatment protocols, and improved procurement systems. These measures are vital to ensure timely treatment and reduce morbidity associated with imported malaria.

PMID:41387872 | DOI:10.1186/s12936-025-05720-z

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Perceptions of obesity among healthcare professionals in Malaysia: a subgroup analysis of the OPEN Models of Care survey

BMC Health Serv Res. 2025 Dec 12. doi: 10.1186/s12913-025-13867-3. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity remains a major and growing public health challenge in Malaysia. This study examined obesity-related perceptions, attitudes, and care practices among Malaysian healthcare professionals (HCP) and decision-makers (HDM), within the multinational Obesity Policy Engagement Network (OPEN) Models of Care survey.

METHODS: This subgroup analysis involved 150 HCP and 53 HDM who responded to questions assessing recognition of obesity as a chronic disease, attitudes toward people with obesity (PwO), and views on system capacity and policy priorities. Responses were analyzed using descriptive statistics and reported as percentages.

RESULTS: Only 27% (n = 55) of respondents recognized obesity as a chronic disease. Notably, 54% of HCP and 51% of HDM acknowledged holding biases against PwO. Although 65% of HCP and 60% of HDM agreed that PwO deserve equal respect, care, and treatment, over half of both groups believed obesity to be the patients’ personal choice and responsibility. Only 56% of HCP and 45% of HDM considered existing obesity services to be adequate. Patient support groups were ranked least important in obesity policy development.

CONCLUSIONS: The findings highlight persistent misconceptions, stigma, and fragmented perceptions among HCP and HDM in Malaysia. A coordinated, system-level approach that recognizes obesity as a chronic disease is essential to improving outcomes for PwO and shaping inclusive, evidence-based policies.

PMID:41387867 | DOI:10.1186/s12913-025-13867-3

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Exploring nurse-patient mutuality in inflammatory bowel disease: a multicenter cross-sectional study

BMC Nurs. 2025 Dec 12. doi: 10.1186/s12912-025-04215-1. Online ahead of print.

ABSTRACT

BACKGROUND: Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), require long-term, multidisciplinary care. Within this model, the nurse-patient relationship is essential, yet little is known about mutuality-defined as shared trust, collaboration, and reciprocity. This study assessed nurse-patient mutuality in IBD using the Nurse-Patient Mutuality in Chronic Illness (NPM-CI) scale.

METHODS: A multicenter, cross-sectional study was conducted in Italian IBD centers. Adult outpatients with confirmed IBD completed the NPM-CI patient version, a 20-item validated tool assessing three dimensions: developing and going beyond, being a point of reference, and deciding and sharing care. Descriptive statistics were used.

RESULTS: Among 453 patients, 449 (94%) completed the NPM-CI. The mean total score was high (81.2 ± 13.3). UC patients reported higher scores than CD patients. The highest-rated items concerned respect for privacy and attention to well-being, while lower scores reflected limited emotional sharing and clarification of information from other professionals.

CONCLUSIONS: This is the first study to evaluate nurse-patient mutuality in IBD using a validated tool. Findings highlight the central role of IBD nurses in building therapeutic relationships. Enhancing emotional communication and shared decision-making could further strengthen mutuality and improve care outcomes.

PMID:41387861 | DOI:10.1186/s12912-025-04215-1

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Validation and Testing of a Suicide Prevention Program in Preventing Suicidal Ideation and Improving the Mental Well-Being of School-Going Adolescents: Protocol for a Pre-Post Intervention Study

JMIR Res Protoc. 2025 Dec 12;14:e67193. doi: 10.2196/67193.

ABSTRACT

BACKGROUND: Globally, around 800,000 people die by suicide annually, with 77% of these deaths occurring in low- and middle-income countries. Suicidal ideation, frequently observed among adolescents, is directly linked to suicide attempts. Pakistan has witnessed a marked escalation in suicide rates in recent years, with Gilgit-Baltistan (GB) reporting the highest incidence. Extensive research indicates that tailored suicide prevention strategies can mitigate suicidal ideation, attempts, and related fatalities.

OBJECTIVE: This study aims to validate and evaluate the efficacy of suicide prevention programs, RAAHI (the guide) and safeTALK, tailored to the cultural and social context of GB, Pakistan, in preventing suicidal ideation and improving the mental well-being of school-going adolescents.

METHODS: The investigation will assess the efficacy of the RAAHI intervention among 267 adolescents across 4 private schools in GB using an interrupted time-series design with a pre-post test framework. The first intervention, RAAHI, a suicide literacy module, is designed to empower participants with the knowledge and skills to recognize signs of suicidal ideation, engage them empathetically, and connect individuals in crisis with appropriate support. The second intervention, safeTALK, a 4-hour educational workshop, incorporates presentations, videos, discussions, and interactive sessions to teach participants the tell, ask, listen, and keep safe steps. Outcome measures include changes in knowledge, confidence, willingness to intervene, and help-seeking behaviors, analyzed using descriptive statistics, 2-tailed paired t tests, and ANOVA. Ethics approval was granted by the Aga Khan University Ethics Review Committee (2023-8509-24844).

RESULTS: As of April 2025, 267 participants have been recruited from 2 of the 4 schools; data collection commenced in March 2025 and is projected to conclude in August 2025. Final results are expected to be published by February 2026.

CONCLUSIONS: This study will offer critical insights into the adaptation and effectiveness of the RAAHI suicide prevention intervention in a low-resource, culturally specific setting. The findings are anticipated to inform scalable suicide prevention initiatives in school settings across Pakistan and similar low- and middle-income contexts, ultimately contributing to reduced suicidal ideation and attempts among adolescents.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67193.

PMID:41385277 | DOI:10.2196/67193

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A case-control study of volumetric segmentation of extraocular muscles from MRI images in thyroid eye disease

Eur J Ophthalmol. 2025 Dec 12:11206721251406426. doi: 10.1177/11206721251406426. Online ahead of print.

ABSTRACT

PurposeThis study aimed to develop a reproducible manual segmentation method using a computer-assisted technique and to (1) compare extraocular muscle volumes between TED patients and healthy controls and (2) assess the intra- and inter-observer reliability of this method.MethodsA retrospective study of MRI scans was performed on 13 patients previously diagnosed with TED and 16 healthy controls. Image segmentation and the derived muscle volume measurements were performed by two independent observers using the software 3D slicer. The groups compared muscle volumes, and intra- and inter-observer reproducibility was assessed.ResultsA statistically significant difference in muscle volume was demonstrated; the mean medial and lateral recti volumes in the TED group were 1342.75 and 1066.7 mm3, respectively, compared to 787.67 and 764.3 mm3 in the control group. The segmentation protocol appears to have good inter-observer reliability. The intraclass correlation coefficient was good for inter-observer measures of the medial recti and intra-observer measures of both horizontal recti.ConclusionThis volumetric analysis verifies that structural MRI contains useful information regarding muscle volume in patients with TED compared to healthy controls. Building a dataset of segmented MRI volumes will help facilitate the creation of supervised machine-learning models for automated volumetric analysis of the extraocular muscles.

PMID:41385270 | DOI:10.1177/11206721251406426

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The Association Between Self-Reported Types of Toxic Exposures and Symptom Severity Among Gulf War Era Veterans

Med Care. 2026 Jan 1;64(2S Suppl 2):S149-S154. doi: 10.1097/MLR.0000000000002212. Epub 2025 Sep 15.

ABSTRACT

BACKGROUND: Gulf War illness is a chronic multisymptom illness impacting Veterans of the 1990-1991 Persian Gulf War. Toxic exposures are believed to be associated with the condition, but little is known about how multiple types of exposures can impact the disease. The aim of this study is to determine if a positive association exists between the multiplicity of exposure types and symptom severity score.

METHODS: A cross-sectional survey design was used in which Persian Gulf Veterans completed a questionnaire with items related to symptom severity and types of self-reported toxic exposures. Linear regression models were used to examine the association between the number of types of toxic exposures and symptom severity scores. We also examined the association between each type of reported exposure and symptom severity score.

RESULTS: Veterans with a greater number of self-reported toxic exposures reported higher scores on symptom severity. While no individual exposure type reached a statistically significant association with symptom score, radiation and biological agent exposures showed the strongest association.

DISCUSSION: We found a positive association between the number of toxic exposure types and total symptom severity. Veterans who self-reported having Gulf War Illness also reported more types of toxic exposures compared with Veterans who did not report having Gulf War Illness. Radiation and biological agent exposure showed the strongest positive association with symptom scores, yet very few Veterans reported isolated exposure of these types. Our findings suggest that cumulative exposure to multiple types of toxins could be associated with the development and severity of Gulf War Illness symptoms.

PMID:41385260 | DOI:10.1097/MLR.0000000000002212

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Comparison of intraocular pressure measurements with and without fluorescein using Goldmann applanation tonometry

Indian J Ophthalmol. 2025 Dec 12. doi: 10.4103/IJO.IJO_676_25. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to evaluate the effect of fluorescein on intraocular pressure (IOP) measurements using Goldmann applanation tonometry (GAT). The study compared IOP readings with and without fluorescein to determine its influence on measurement accuracy in clinical practice.

METHODS: This cross-sectional study included 39 patients (78 eyes). IOP was measured three times under each condition: fluorescein-free with green light and fluorescein-aided with cobalt blue light. The prespecified primary comparison was between the first fluorescein-free reading and the first fluorescein-aided reading, separated by approximately 1 minute (the time needed to apply fluorescein). Statistical analysis (repeated-measures ANOVA for within-series change; Wilcoxon signed-rank tests for paired comparisons) was used to compare measurements, while corneal astigmatism, keratometry, and central corneal thickness were assessed for their potential influence on discrepancies. A sensitivity analysis excluding patients with >3.0 D corneal astigmatism was conducted.

RESULTS: No significant difference was found between the first fluorescein-free and first fluorescein-aided IOP measurements (Wilcoxon P = 0.75; mean difference +0.04 mmHg). Consecutive measurements showed significant IOP reductions within each group, attributed to mechanical effects of the tonometer (repeated-measures ANOVA P < 0.01). Corneal parameters, including central corneal thickness and keratometry, did not significantly affect the differences. Results were unchanged after excluding patients with >3.0 D astigmatism.

CONCLUSIONS: Fluorescein does not significantly affect IOP measurements using GAT, supporting fluorescein-free measurement as a viable alternative in routine practice. Further research is needed to evaluate its application in cases of high astigmatism or altered corneal geometry.

PMID:41385238 | DOI:10.4103/IJO.IJO_676_25

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Outcomes of Infants Born at 21 Weeks’ Gestational Age

JAMA Netw Open. 2025 Dec 1;8(12):e2548211. doi: 10.1001/jamanetworkopen.2025.48211.

ABSTRACT

IMPORTANCE: Advances in medical care and clinician experience have lowered the gestational age at which resuscitation is considered for extremely premature infants. Some centers now offer trials of resuscitation at 21 weeks’ gestational age. Minimal data are available to guide this practice.

OBJECTIVE: To describe morbidities and outcomes of resuscitated infants at 21 weeks’ gestational age.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective case series included all infants born at 21 weeks’ gestational age in a single-center level IV academic neonatal intensive care unit (NICU) at the University of Iowa from January 1, 2020, through February 28, 2025. Data were analyzed from April 1 to August 15, 2025.

EXPOSURE: Extremely preterm birth at a gestational age of 21 weeks.

MAIN OUTCOMES AND MEASURES: Demographic characteristics, therapies, morbidities, and test results were collected throughout hospitalizations from electronic medical records for extremely premature infants who received any attempted resuscitation and their mothers, including hourly cardiorespiratory data for the first 72 hours for infants admitted to the NICU. Postdischarge outcomes through the end of the study period were collected as available.

RESULTS: Twenty-two infants were born alive at 21 weeks’ gestational age during the study period, and an additional 230 were stillborn. Resuscitation was attempted in 17 (77%) of the infants born alive; of these, 6 (35%) survived to discharge from the NICU (earliest in 2021; youngest, 21 weeks, 0 days; birth weight, 285-430 g), 1 (6%) remained hospitalized, and 10 (59%) died. All births were inborn vaginal deliveries. Infants who survived (including the infant who remained hospitalized) were less likely part of a multiple gestation compared with those who did not (1 of 7 [14%] vs 6 of 10 [60%]) and more likely exposed to a complete course of antenatal corticosteroids (3 of 7 [43%] vs 0 of 10). Most of the infants who survived had early cardiorespiratory instability treated with vasoactive medications and/or inhaled nitric oxide (5 [71%]). Three (43%) had no or grade 1 intraventricular hemorrhage (IVH), 2 (29%) had grade 2 IVH, and 2 had severe (grade 3) IVH (29%); none required neurosurgical intervention. The 6 infants who were discharged received low-flow supplemental oxygen, and none required tracheostomy. Rates of resuscitation increased during the study period.

CONCLUSIONS AND RELEVANCE: In this case series of infants born alive at 21 weeks’ gestational age, selective resuscitation resulted in 35% survival to discharge, in some cases with minimal morbidities. These descriptive data may prompt prospective study and reporting at this gestational age. Long-term outcome data are needed.

PMID:41385227 | DOI:10.1001/jamanetworkopen.2025.48211

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Antiretroviral Therapy Changes for Medicare Beneficiaries With HIV Transitioning to Long-Term Care

JAMA Netw Open. 2025 Dec 1;8(12):e2548936. doi: 10.1001/jamanetworkopen.2025.48936.

ABSTRACT

IMPORTANCE: Studies of nursing home (NH) residents show lower than expected antiretroviral therapy (ART) use, but it is unclear whether ART use changes across the transition from the community to long-term NH stay.

OBJECTIVE: To examine changes in ART use across the transition from the community to long-term NH stay.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study examined long stays in US NHs for people with HIV in a sample of 5% of Medicare claims from 2014 to 2019. Stays were at least 30 days long, had at least 3 months between multiple stays, and were for those continuously enrolled in Medicare for the stay and 6 months before. Analysis was completed in May 2025.

EXPOSURES: Admission year demographics included age, race and ethnicity (non-Hispanic Black, non-Hispanic White, and other [American Indian or Alaska Native, Asian or Pacific Islander, other, and unknown]), binary sex, Medicaid eligibility, whether the stay was preceded by a skilled nursing stay, and whether disability was Medicare original eligibility. NH characteristics included for-profit status, census region, and facility quality rating.

MAIN OUTCOMES AND MEASURES: Linear regression estimated changes in the proportion of days covered by 3-drug ART, and hierarchical multinomial logistic regression estimated the risk of never having, losing, or gaining ART vs always having it, across the transition from the community to long-term NH stay.

RESULTS: There were 713 long NH stays for 657 people with HIV (mean [SD] age, 61.0 [11.4] years) across 598 facilities; 271 stays (38%) were for people aged 65 years and older. Only 23 individuals lost ART (3%), 97 individuals (14%) gained ART, 185 individuals (26%) never had ART, and 408 individuals (57%) always had ART across the transition. Excluding those who lost ART, all other groups were mostly men (never, 132 men [71%]; always, 289 men [71%]; gained, 72 men [74%]) and Black (never, 85 individuals [46%]; always, 237 individuals [58%]; gained, 58 individuals [60%]). There was an increase in the proportion of days covered (mean intercept α = 13.92; 95% CI, 9.57-18.29). Compared with always having ART, Black race (relative risk [RR], 0.52; 95% CI, 0.35-0.77), polypharmacy (RR, 0.41; 95% CI, 0.23-0.74), and disability as original Medicare eligibility (RR, 0.47; 95% CI, 0.29-0.77) were associated with lower risk of never having ART. For-profit facilities were associated with higher risk (RR, 1.63; 95% CI, 1.03-2.59) of never having ART. Polypharmacy was associated with lower risk of gaining ART (RR, 0.15; 95% CI, 0.05-0.49).

CONCLUSIONS AND RELEVANCE: These findings suggest that long-term NH stays may be associated with improved ART use among people with HIV because most stays without ART never had ART before admission.

PMID:41385225 | DOI:10.1001/jamanetworkopen.2025.48936