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Mortality and health outcomes associated with non-communicable disease risk factors: Protocol for the IRAN-STEPS Follow-Up Cohort (ISFUC) based on the 2021 national survey

by Hosein Ataei-Goujani, Sarmad Salehi, Pardis Zarepour, Ozra Tabatabaei-Malazy, Nazila Rezaei, Mina Mirzad, Anis Gharajeh, Samaneh Akbarpour, Yosra Azizpour

Non-communicable diseases (NCDs) account for more than 81% of all deaths in Iran and impose a substantial burden on the national health system. Although Iran has implemented multiple initiatives, including the World Health Organization’s STEPwise Approach to NCD Risk Factor Surveillance (STEPS), to monitor NCD risk factors, critical gaps remain in longitudinal outcome assessment, particularly in the post–COVID-19 period, for which national data are limited. Moreover, in the context of declining fertility rates and demographic challenges in Iran, emerging evidence suggests that metabolic and lifestyle-related NCD risk factors are associated with impaired reproductive health, fertility potential, and childbearing behaviors. Therefore, the assessment of reproductive outcomes within population-based NCD surveillance frameworks addresses an important knowledge gap in Iran. The Iran STEPS Follow-Up Cohort (ISFUC) is established to evaluate mortality, health outcomes related to NCD risk factors, and fertility related outcomes using population-based data from the 2021 STEPS survey. The ISFUC is a population-based cohort study established through follow-up of participants from the nationally representative 2021 Iranian STEPS survey. The 2021 STEPS survey constitutes the baseline assessment, whereas ISFUC represents the subsequent follow-up phase. Baseline assessments were collected through interviewer-administered questionnaires, standardized physical measurements, and laboratory analyses of blood and urine biomarkers. Follow-up began in 4 April 2025, a five-years interval after baseline, and is ongoing. It will be conducted through structured telephone interviews by trained staff after renewed verbal consent. Study outcomes include all-cause mortality, healthcare utilization, injuries, reproductive health indicators, fertility-related behaviors and attitudes, and use of governmental childbearing support policies. Mortality outcomes are validated through linkage with the national death registry. Questionnaire validity was ensured using expert review, the Content Validity Ratio, and the Content Validity Index methods. By linking comprehensive 2021 STEPS baseline data with follow-up information on health, healthcare utilization, mortality, and reproductive outcomes, ISFUC provides a national platform for investigating Iran’s evolving epidemiological and demographic health challenges.

Lifestyle behaviours, glucose management and diabetes awareness among Iranian population with diabetes: evidence from a nationwide study

Por: Mozafari · S. · Ataei-Goujani · H. · Behgam · N. · Mirzad · M. · Karimi · K. · Tabatabaei-Malazy · O. · Pejman Sani · M.
Objective

To investigate the association between a Composite Lifestyle Index (CLI) and glucose management among Iranian adults with diabetes and to assess the geographic distribution of lifestyle behaviours.

Design

Cross-sectional.

Setting

A population-based nationally representative survey conducted across all 31 provinces of Iran based on data from the 2021, the latest, WHO STEPwise Approach to Noncommunicable Disease Risk Factor Surveillance (STEPS) survey.

Participants

Adults aged ≥25 who completed the third step of the STEPS study and met one or more of the following criteria—fasting blood sugar (FBS) of 126 mg/dL or higher, haemoglobin A1c (HbA1c) of 6.5% or higher or current use of glucose-lowering medications. Finally, 3042 adults with diabetes were included in the analysis.

Primary and secondary outcome measures

A CLI was derived from diet, physical activity, smoking and alcohol consumption and categorised into tertiles representing the lowest, moderate and highest engagement in healthy lifestyle behaviours. Diabetes awareness was assessed by self-report, and suitable glucose management was defined as HbA1c

Results

In fully adjusted models, moderate lifestyle engagement was significantly associated with lower FBS (aß=–7.36, 95% CI –13.35 to –1.38, p=0.01) and lower HbA1c (aß=–0.27, 95% CI –0.46 to –0.07, p=0.00) compared with the lowest tertile. Additionally, improving the CLI from the first to second tertile was associated with 1.37 times higher odds of achieving suitable glucose management (p=0.01). Restricted cubic spline analysis confirmed a significant non-linear relationship between continuous CLI and both FBS (Pnon-linearity=0.002) and HbA1c (Pnon-linearity=0.005), with maximal glycaemic benefits observed at moderate CLI values.

Conclusions

The relationship between healthy lifestyle behaviours and glycaemic outcomes among Iranian adults with diabetes was non-linear, a U-shaped pattern. Glycaemic benefits peaked at moderate engagement levels, and diminished at the highest levels of engagement. These exploratory findings suggest that moderate lifestyle engagement may be associated with improved glycaemic outcomes, highlighting the need for prospective studies to evaluate whether integrating tailored lifestyle promotion into diabetes management can effectively benefit underserved regions.

Potentially inappropriate prescribing in Iranian elderly population: a nationwide claims-based analysis

Por: Kharaghani · M. A. · Kianipour · R. · Ataei · S. M.-N. · Ebrahimpour · S. · Shahali · Z. · Golestani · A. · Tabatabaei-Malazy · O.
Objective

Potentially inappropriate prescribing (PIP) in the elderly is associated with adverse outcomes and increased healthcare use. We aimed to estimate its prevalence and pattern among the elderly population of Iran using the Screening Tool of Older Persons’ Prescriptions (STOPP) criteria.

Design

Retrospective, population-based observational study.

Setting

Nationwide data of Iran Health Insurance Organization (IHIO) prescription claims from 24 provinces (21 March 2014 to 19 March 2017).

Participants

Adults aged ≥60 years with at least one prescription in the dataset were included. The study comprised 2 696 300 older adults who received 28 575 400 prescriptions.

Interventions

Not applicable.

Primary and secondary outcome measures

Using a two-stage curation process, we selected STOPP version 3 criteria that could be operationalised from dispensing data alone (age, Anatomical Therapeutic Chemical code, dose, duration and concurrent use). For each criterion, we calculated prescription and patient level PIP prevalence overall and among at-risk prescriptions.

Results

Across the curated STOPP criteria, 313 315 prescriptions issued to 131 012 patients met at least one PIP criterion. The most frequent PIPs were concurrent beta blocker and diltiazem use (99 027 prescriptions; 1.26% of patients), benzodiazepine therapy ≥4 weeks (89 240 prescriptions; 1.60% of patients), ≥2 anticholinergic drugs (47 079 prescriptions; 0.78% of patients) and concomitant non-steroidal anti-inflammatory drug plus anticoagulant (25 685 prescriptions; 0.38% of patients). PIPs involving acetylcholinesterase inhibitors, ticlopidine, clonidine and methyldopa were rare.

Conclusions

In this nationwide claims-based study, about 5% of elderly Iranians were exposed to PIPs, particularly chronic benzodiazepine use, excessive anticholinergic burden and high-risk cardiovascular and antithrombotic combinations. Our findings provide concrete targets for claims-based surveillance and interventions to improve prescribing safety in Iran’s ageing population.

Realist review protocol on user involvement in complex interventions in health and social care research among populations experiencing exclusion

Por: Gaber · S. N. · Rapaport · P. · Johnson · L. · Eriksson Lundström · J. · Kneck · A. · Mattsson · E. · Siersbaek · R.
Introduction

User involvement is important for improving accessibility, quality and equity in health and social care research. However, the specific mechanisms by which it contributes to, or detracts from intervention outcomes are unclear, particularly for populations experiencing exclusion and health and social inequities in high-income countries. This realist review aims to understand and describe key mechanisms of user involvement in complex interventions in health and social care research among populations experiencing exclusion in high-income countries. Specifically, we will explore how, why, for whom and under what circumstances user involvement contributes to complex interventions in health and social care research among populations experiencing exclusion.

Methods and analysis

We will conduct a six-step realist review: (1) clarifying the scope, (2) searching for evidence, (3) selecting and appraising sources, (4) extracting and organising data, (5) synthesising data and (6) refining the synthesis. We will systematically review and synthesise relevant sources from academic databases and grey literature. Workshops will be held with experts who have lived experience of exclusion and/or professionals working in inclusion health to gather feedback and refine the findings. A group of external academic experts in the field will also be consulted. Following Pawson and Tilley’s iterative approach, data will be extracted, analysed and synthesised into explanatory theoretical findings and reported in accordance with the Realist And Meta-narrative Evidence Syntheses Evolving Standards.

Ethics and dissemination

Formal ethical approval is not required for this study as it is a review of published literature. Our overall dissemination strategy will be developed in collaboration with the experts who have lived experience of exclusion, as well as three professionals working in inclusion health. Findings will be shared with these expert contributors and disseminated through various channels, including a peer-reviewed publication, lay summary report and conference presentations.

PROSPERO registration number

CRD420251046835.

Postbiotic effects of <i>Enterococcus faecium</i> JB00008 on gut health and IBD vaccination in broiler chickens

by Seonju Lee, Seojin Choi, Jongbin Park, Biao Xuan, Eun Bae Kim

Feeding various probiotic lactic acid bacteria, including Enterococcus faecium, can alleviate intestinal inflammation and improve gut health in animals. Recently, postbiotics—non-living preparations derived from microbial cells or their metabolites—have gained attention. However, studies on the effects of these postbiotics on immune markers and changes in the gut microbiota of chickens are limited. In this study, we evaluated the effects of the probiotic strain E. faecium JB00008 on the chicken intestinal tract and characterized immune markers and gut microbiota following viral vaccination. Chicks were divided into three groups (Control, DH5α, and JB00008) and administered the respective supernatants in drinking water from days 1–12 at a 3:7 ratio. Samples were collected on days 13 and 28 for microbiota and gene expression analyses. To immunize against infectious bursal disease (IBD), the chicks received an oral vaccine on day 13. Growth, immune, and gut parameters were measured. Body weights did not differ among groups (p = 0.380). Several intestinal immune markers—mucin 2 (MUC2, p = 0.001), occludin (OCLN, p IL-10, p ANXA5, p = 0.005) and interleukin-6 (IL-6, p p = 0.200) and IgG (p = 0.065) responses were comparable; however, the alpha (p p = 0.001) were significantly different among the groups. The JB00008 group showed higher Enterococcus and Bifidobacterium, with enrichment of pathways associated with iron complex transport systems (p E. faecium JB00008 as a feed additive and vaccine adjuvant.

Relationship between perceived social support and domestic violence with maternal postpartum stress in Iranian women: a cross-sectional study

Por: Shabani · F. · Montazeri · M. · Yousefi Tabaei · F. · Mirghafourvand · M.
Objectives

This study aimed to investigate the relationship between perceived social support and domestic violence with maternal postpartum stress in an Iranian context.

Design

This cross-sectional study was conducted in 2023 in Tabriz, Iran.

Setting and participants

A total of 349 mothers, 2–6 months post partum, who were living with a spouse and had no history of mental health disorders, were selected from municipal health centres using a cluster sampling method.

Primary and secondary outcome measures

Data were collected using the Maternal Postpartum Stress Scale, the Perceived Social Support Questionnaire (Personal Resource Questionnaire-85 (PRQ-85)), and the Hurt, Insult, Threaten, Scream tool for domestic violence. Data were analysed using descriptive statistics, bivariate tests (independent samples t-tests, one-way analysis of variance and Pearson’s correlation coefficient) and generalised linear model.

Results

Maternal postpartum stress showed a significant negative correlation with perceived social support (r=–0.16, p=0.002) and a significant positive correlation with domestic violence (r=0.14, p=0.006) in the initial analysis. In the final adjusted general linear model with robust standard errors, perceived social support was significantly associated with lower stress (B=–0.1, p

Conclusions

This study reveals a complex web of associations where perceived social support, domestic violence, economic stability and the model of birth care are linked to maternal postpartum stress. These findings highlight the urgent need for systemic support structures that empower the family unit and prioritise the emotional health in the postpartum period.

Cost-effectiveness of the sFlt-1/PlGF ratio and telemonitoring in managing suspected pre-eclampsia: protocol for the PREPARE II randomised controlled trial

Por: Wind · M. · Peters · A. · van den Akker-van Marle · M. E. · Vanden Auweele · K. · van Bodegom-Vos · L. · Boekhorst · F. · Cobbaert · C. M. · Hermes · W. · Van Hoorn · M. E. · Van Den Haak · L. · Lutke Holzik · M. · Tsonaka · R. · Van Wyk · L. · Teng · Y. K. O. · Sueters · M.
Introduction

The soluble FMS-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio has demonstrated impressive predictive test characteristics in women with suspected pre-eclampsia. However, it remains a matter of debate whether the introduction of this novel test can indeed translate to a reduction in pre-eclampsia-related hospital admissions, outpatient visits and can consequently lower overall healthcare costs. The PREPARE II study aims to investigate whether the sFlt-1/PlGF ratio, along with digital self-monitoring, can reduce pre-eclampsia-related healthcare utilisation in the first week following the test for women with suspected pre-eclampsia.

Methods and analysis

This is a randomised controlled trial across six centres which includes women (≥16 years old) between 20 and 37 weeks of gestation with suspected pre-eclampsia due to one or more identified symptoms. For power calculation, we assumed that the sFlt-1/PlGF ratio including a telemonitoring strategy leads to a de-escalation of care by cumulatively reducing the frequency of pre-eclampsia-related hospital admissions and/or outpatient visits in the first week from 50% in the control group to 35% in the intervention group. Considering a loss to follow-up of 5%, a sample size of approximately 470 women is required with 235 women per arm (α=5%; power=90%). The intervention is an algorithm based on the urine protein/creatinine ratio (PCr)+sFlt-1/PlGF ratio, along with a telemonitoring strategy. The algorithm incorporates a PCr cut-off of 30 (mg/mmol) and a sFlt-1/PlGF ratio cut-off of 38 for risk classification. Subsequent clinical follow-up recommendations are stratified based on this classification: low risk entails no additional follow-up, returning to routine antenatal care; intermediate risk includes telemonitoring; high risk necessitates immediate admission. The primary outcome is the occurrence of pre-eclampsia-related healthcare utilisation in the first week after testing. Secondary outcomes are maternal/perinatal adverse events, total healthcare usage, pre-eclampsia diagnosis, quality of life and productivity losses. A cost-effectiveness analysis from a societal perspective will be performed.

Ethics and dissemination

Ethical approval was obtained from the Medical Ethics Committee of Leiden University Medical Centre (METC LDD) on 21 July 2025 (reference NL-009295). The results will be disseminated through peer-reviewed publications and presentations at international conferences.

Trial registration

NL88527.058.24.

Mapping cancer literacy levels, barriers and facilitators, educational initiatives and misinformation narratives: multiple scoping review protocol

Por: Beccia · F. · Lacalaprice · D. · Girvalaki · C. · Geanta · M. · Pastorino · R. · CURTAIN WP2 collaborating group · Tona · Oppong · Malenkovic · Cuoco · Villani · Bruno · Boccia · Schitea · Barreto · Sousa-Uva · Dantas · Cabrita · Apted · Santos · Sousa · Vujovic · Baev · Semenov · K
Introduction

Cancer literacy (CL) is essential for enabling informed decision-making, prevention, early detection and adherence to treatment. However, disparities in CL across Europe, coupled with the spread of disinformation, limit equitable access to cancer care. This protocol describes a collection of scoping reviews to document the state of CL, misinformation narratives and education and training initiatives and identify barriers and facilitators. This work is embedded within the activities of the Beating Cancer Inequalities through Literacy in Europe project and encompasses nine consortium countries across Europe: Romania, Portugal, Belgium, Bulgaria, Montenegro, Ukraine, Italy, Ireland and Moldova.

Methods and analysis

The protocol follows the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews(PRISMA-ScR) checklist, guided by the Population, Concept, Context framework. Searches will be conducted in PubMed, supplemented by grey literature, capturing results from January 2015 to December 2025. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting the topics of interest, developed by the research team before extraction to include key study information. Then, sources in local languages are provided by the partners, included and validated by native-speaking team members, adding to the results found by the researchers.

Ethics and dissemination

No ethical approval is required. Findings will be disseminated via peer-reviewed publications, project reports and stakeholder workshops.

Study registration

Open Science Framework (10.17605/OSF.IO/9AQSX).

Long‐Term Clinical and Radiologic Evaluation of Micronized Acellular Dermal Matrix‐Assisted Reconstruction in Diabetes‐Related and Traumatic Foot Wounds With Bone Defects

ABSTRACT

To investigate whether micronized acellular dermal matrix (mADM) can be used to treat diabetes-related and traumatic foot wounds with bone defects after bone or joint resection. We retrospectively reviewed 52 patients who underwent bone or joint resection, followed by mADM-assisted reconstruction of diabetes-related or traumatic foot wounds between 2021 and 2024. mADM was applied using sheet-type, paste-type or combined formulations in one- or multi-stage procedures. Wound healing, contour preservation and radiological alignment were assessed. Among the 52 patients (43 with diabetes and 9 with trauma), complete epithelialization was achieved in 48 (mean follow-up: 14.8 months; mean time to wound closure: 5.6 weeks). Four cases showed recurrence or delayed healing and five developed mild early local infection; all were controlled with additional wound care or antibiotics, with no progressive osteomyelitis or graft loss. In 40 radiologically evaluable cases, the toe length and alignment were generally preserved (mean toe length ratio: 91.6% and no angular deformity > 10°). mADM-assisted reconstruction may be useful for treating diabetes-related and traumatic foot wounds with bone defects after bone or joint resection. Its role appears to lie in dead-space management, contour preservation and durable wound coverage, rather than bone replacement.

Health and well-being of mothers and co-parents during the first 12 months post partum: study protocol of the national SOCRATES cohort study in Switzerland

Por: Gaucher · L. · Desplanches · T. · Sormani · J. · Cattani · G. · Mueller · A. N. · Celetta · E. · Widmer · I. N. · Lorthe · E. · Grylka-Baeschlin · S.
Introduction

The first year after childbirth is a critical yet insufficiently monitored period for parental health. Postpartum mental and physical morbidity can affect both mothers and co-parents, but national longitudinal data remain scarce. The Stress Of Co-parents Related to A Traumatic Experience of birth across Switzerland (SOCRATES) cohort study aims to describe maternal and co-parental health and well-being trajectories during the first year after childbirth.

Methods and analysis

SOCRATES is a prospective, population-based cohort study conducted in all linguistic regions of Switzerland. Eligible participants include women aged 14 and above who gave birth to a live or stillborn infant (≥22+0 weeks’ gestation and ≥500 g) and their cohabiting co-parents, provided they speak German, French, Italian or English. Recruitment was conducted in 81 of the 112 Swiss maternity units, birth centres and organisations of midwives over 6 weeks in spring 2025. Clinical data on pregnancy, childbirth and the early postpartum period are extracted from medical records. Postpartum hospitalisation data are obtained through linkage with national medico-administrative databases. Participants complete online questionnaires shortly after birth and at 2, 6 and 12 months post partum, including sociodemographic characteristics and patient-reported outcomes. The primary outcome is the prevalence of childbirth-related post-traumatic stress disorder at 2 months, assessed using the City Birth Trauma Scale. Secondary outcomes include depression, physical recovery, sexual health, quality of life, healthcare use, perceived care quality and overall well-being. A weighting procedure will be used to ensure representativeness and to account for attrition.

Ethics and dissemination

Ethical approval was granted by all seven Swiss ethics committees (number 2024-02262). All participants provided informed consent. Findings will be disseminated through national and international conferences, peer-reviewed publications, policy briefs, social media and stakeholder engagement activities.

Trial registration number

NCT06886841.

Preschool and primary school teachers’ attitudes toward students with type 1 diabetes: A cross-sectional study

by María Yehisiri Martín–Báez, Candelaria de la Merced Díaz-González

Introduction

Type 1 diabetes mellitus (T1DM) is the most common chronic endocrine disorder in childhood, making teachers key agents in ensuring a safe school environment. The main objective of this study was to evaluate the attitudes and prejudices of teachers at Public Early Childhood and Primary Education Centres (ECPECs) in the municipality of San Bartolomé de Tirajana (SBTGC), on the island of Gran Canaria (Canary Islands, Spain), regarding the care of students with T1DM.

Materials and methods

A descriptive cross-sectional study was conducted. The target population consisted of 264 teachers from seven ECPECs schools in the municipality of SBTGC, Gran Canaria. Data collection was carried out using the validated instrument Teacher Negative Attitudes Index toward the Care of Students with Type 1 Diabetes Mellitus (INAPAD-18), which allowed for the evaluation of teachers’ attitudes and provided an answer to the study’s main objective. The research was approved by the Research and Drug Ethics Committee (CEIm) of Las Palmas.

Results

The final sample consisted of 126 participants, representing a participation rate of 47.72%, which did not reach the size required for statistical representativeness. A total of 15.87% of teachers reported currently having students diagnosed with T1DM. The mean number of years of experience working with students with this condition was 3.77 years [0–35years]. A marked gender disparity was observed, with a predominance of women (84.12%). The mean score obtained on the INAPAD-18 questionnaire was 47.02 (range: 18–90). In this instrument, lower scores indicate more favourable attitudes toward the care of students with T1DM. Although male participants showed more favourable attitudes compared to their women, this difference was not statistically significant (p > 0.05).

Discussion/Conclusion

The results indicate generally favourable attitudes, with moderately low INAPAD-18 scores. However, slight deficiencies were observed in teachers’ training and perception, consistent with findings from previous similar studies. The ECPEC schools Juan Grande and Las Dunas stood out for demonstrating the most positive attitudes. It is necessary for educational institutions to implement specific measures aimed at teacher training in order to improve attitudes and ensure appropriate attention to the needs of students with T1DM.

Impact of 'spin on medical decision-making among healthcare professionals and other health-related decision makers: a systematic review protocol

Por: Bae · I. · Choi · S. · Ryu · S. · Park · H. · Kim · M. · Lee · H.
Introduction

‘Spin’ refers to reporting practices that distort the interpretation of results and mislead readers’ impression of the research findings so that the results are viewed in a more favourable light. This systematic review aims to assess the impact of spin on the impressions and/or interpretation of research findings among healthcare professionals and decision makers involved in health-related decision-making and to evaluate interventions/strategies designed to reduce the influence of spin.

Methods and analysis

This systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE (via Ovid), EMBASE, the Cochrane Library (CENTRAL) and the Education Resources Information Center (ERIC) will be searched from their inceptions to 27 January 2026. Randomised controlled trials evaluating the impact of spin on participants’ impressions and/or interpretation of research findings, as well as trials assessing the effect of interventions/strategies on the recognition and interpretation of spin, will be considered. Study selection, data extraction and risk of bias (RoB) assessment with the Cochrane RoB2 tool will be performed independently by multiple reviewers. Where sufficient data are available, meta-analyses will be conducted.

Ethics and dissemination

As this study is based on a review of publicly available literature, ethical approval is not required. The findings will be disseminated through publication in peer-reviewed journals, presentations at international conferences and press releases.

Trial registration number

INPLASY202620006.

ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy

Por: Olsson · K. S. · Baekelandt · J. F. · Källen · K. · Matak · L. · Caretto · M. · Wassen · M. M. L. H. · Simoncini · T. · Stuart · A.
Introduction

Adnexal surgery is one of the most common surgeries performed in women. Minimally invasive methods are on the rise globally as they have been shown to decrease surgical morbidity compared with abdominal surgery. Adnexal surgery by vaginal natural orifice transluminal endoscopic surgery (vNOTES) is the latest innovation. It combines the vaginal approach and endoscopy via the vagina. Large pragmatic randomised controlled trials (RCTs) are lacking comparing outcomes after vNOTES and conventional laparoscopy.

Methods and analysis

A multicentre pragmatic RCT aiming to recruit 200 women aged 18 years and above undergoing adnexal surgery for benign disease or prophylactic reasons. Patients will be randomised to vNOTES or laparoscopy. Recruitment will start Q4 2025, and the study is estimated to end 2028.

The primary outcome is postoperative pain. Secondary outcomes are units of postoperative opioid and non-opioid analgesics used, perioperative complications, operation time, postoperative complications, readmission, conversion rate and the surgeon’s experience.

Ethics and dissemination

The national Swedish ethical board at the main centre, Helsingborg Hospital, Sweden, has given ethical agreement (dated 20 March 2025). Before including patients, all centres will require local or national ethical approval. The results of the study will be published in international peer-reviewed journals.

Trial registration number

NCT06964594.

ODIN Biobank: a Danish cohort for dementia research- cohort profile

Por: Laugesen · K. · Skjaerbaek · C. · Okkels · N. · Moller · H. J. · Borghammer · P. · Gottrup · H. · Parkner · T.
Purpose

Biomarkers related to the diagnosis, prognosis and treatment of dementia will play a key role in future clinical practice. The overarching aim of the ODIN (blood and cerebrospinal fluid) Biobank is to study biomarkers for dementia and contribute to the transition from cerebrospinal fluid to blood-based biomarkers.

Participants

ODIN recruited 451 patients (median age 74 years, 53% females) referred to the Department of Neurology at Aarhus University Hospital, Denmark, for diagnostic assessment of dementia. Enrolment started in March 2020 and ended in July 2025. Patients referred for a lumbar puncture were eligible for inclusion. Cerebrospinal fluid and blood samples (plasma, serum and buffy coat) were stored at –80°C. Information about sociodemographic, educational level, dementia subtype, cognitive test scores, neuroimaging results, hypertension, diabetes, height, weight, alcohol consumption and smoking was collected.

Findings to date

The most frequent diagnoses were Alzheimer’s disease (n=268, 59%), frontotemporal dementia (n=26, 5.8%) and mixed Alzheimer’s and vascular disease (n=23, 5.1%). N=82 (18%) were cognitively unimpaired or had mild cognitive impairment but not dementia. The median Mini–Mental State Examination score was 23 (IQR: 20–26) and the median Addenbrooke’s Cognitive Examination score was 68 (IQR: 58–77).

Future plans

ODIN will contribute to the development, validation and implementation of new biomarkers related to diagnosis, prognosis and treatment of dementia. Furthermore, the cohort will assist the transition from cerebrospinal fluid to blood-based biomarkers.

Pre-diagnostic route reported by patients with sarcoma from the Netherlands, the UK, Australia and New Zealand: early detection challenges for general practitioners - an international observational cohort study

Por: Holthuis · E. I. · Soomers · V. L. M. N. · Rafiq · M. · Jones · R. L. · Hayes · A. · Van De Wal · D. · Drabbe · C. · Been · L. B. · Bonenkamp · H. · van der Hage · J. H. · Lee · A. T. J. · Verhoef · C. · van Houdt · W. J. · Young · R. J. · Bae · S. · Andelkovic · V. · Hong · A. M. · Conn
Objective

To investigate how patients with sarcoma present prior to diagnosis—through a general practitioner (GP) or another healthcare professional (HCP)—and describe presenting symptoms.

Design

International observational cohort study.

Setting

Data were obtained from the longitudinal ‘QUality of life and Experiences of Sarcoma Trajectories’ (QUEST) cohort study, conducted across the Netherlands, the United Kingdom (UK), Australia and New Zealand.

Results

Among 572 patients, 487 (85.1%) started their diagnostic trajectory at the GP (subcohort 1) and 85 (14.9%) with another HCP (subcohort 2)—mainly medical specialists treating unrelated conditions (36/85; 42.4%). Soft tissue sarcoma patients most often reported swelling, whereas bone sarcoma patients reported unexplained pain. Notably, 31/85 (36.5%) of subcohort 2 were asymptomatic. Reasons for delaying GP visits included assuming symptoms were minor and expecting them to resolve. Patients sought care when, among others, symptoms persisted and worsened.

Conclusions

Most patients first consulted a GP, underlining the role of primary care in sarcoma diagnosis internationally. Due to rarity and nonspecific symptoms, faster diagnosis remains challenging, requiring improvements in both primary and specialist care.

Trial registration number

NCT03441906; Results.

Enhanced Wound Healing Through Air‐Break Augmentation of Hyperbaric Oxygen Therapy Combined With Adipose‐Derived Stromal Cell Transplantation in a Murine Model

ABSTRACT

Hyperbaric oxygen therapy (HBOT) enhances wound healing by promoting angiogenesis and reducing hypoxia. However, the role of air-breaks—intermittent exposures to ambient air during HBOT—remains unclear. We investigated the effects of air-breaks on HBOT-mediated wound healing, particularly in combination with adipose-derived stromal cells (ASCs). Full-thickness wounds were created in C57BL/6 mice (n = 36) and assigned to control, HBOT (1 h/day, 2 ATA for 11 days), or HBOT with a 10-min air-break groups. In a second experiment, we evaluated ASC treatment combined with HBOT and air-breaks. Wound healing was assessed via gross examination, histology and gene expression analysis of collagen type 1 alpha 1 (Col1a1), hypoxia-inducible factor 1 alpha (Hif1a) and tumour necrosis factor (Tnf-α). Compared with HBOT alone, air-breaks significantly improved wound closure, epithelial regeneration and collagen deposition (p < 0.05). Gene analysis showed higher Col1a1 expression and lower Hif1a and Tnf-α levels in the air-break group. In ASC-treated wounds, air-breaks further accelerated healing, enhancing collagen synthesis and reducing hypoxia and inflammation. These findings suggest that incorporating air-breaks into HBOT protocols improves wound healing outcomes, both generally and in ASC-based therapies, by modulating collagen production, hypoxia and inflammation, and could optimise HBOT efficacy, particularly in cell-based regenerative therapies.

Genetic ablation of interleukin-17A augments fibrosis in a mouse model of cholestatic liver injury

by Takashi Kitagataya, Anuradha Krishnan, Kirsta E. Olson, Florencia Gutierrez, Michelle Baez-Faria, Maria Eugenia Guicciardi, Kevin D. Pavelko, Adiba I. Azad, Gregory J. Gores

Aim

The underlying mechanisms contributing to cholestatic liver injury remain unclear. The pro-inflammatory leukocyte-restricted cytokine interleukin-17A (IL-17A) has been implicated in human cholestatic liver injury. However, mechanistic insights are lacking and require further exploration in preclinical models. Herein, we examined the effect of IL-17A genetic ablation in a mouse model of cholestatic liver injury.

Method

Age and gender-matched littermate wild type (WT) and Il-17a-/- C57BL/6 mice were fed an intermittent 0.1% 3,5-diethoxycarbonyl-1,4-dihydrocollidine (DDC) diet for 21 days to induce cholestatic liver injury or a control diet.

Results

As compared to WT littermates, Il-17a-/- mice displayed more abundant desmin-positive myofibroblasts and increased fibrosis. NanoString analysis of intrahepatic leukocyte populations using a fibrosis-related gene panel identified upregulation of Tnfsf14 (encoding the protein LIGHT) in the DDC-fed Il-17a-/- mice. Although mass cytometry identified an increase in myeloid cells in both genotypes of the DDC-fed mice, we could not identify LIGHT expression in this cell lineage. Instead, the upregulation of LIGHT expression was largely restricted to a CD4+ T cell population as assessed by flow cytometry. Enhanced LIGHT expression was observed in a Th1+ CD4+ T cell population. LIGHT activated primary human hepatic stellate cells in vitro, suggesting that LIGHT stimulation of hepatic fibrogenesis may be direct.

Conclusion

Taken together, these data suggest that IL-17A restrains expression of the profibrogenic cytokine, LIGHT, by Th1-polarized CD4+ T cells, and implicate a role for LIGHT in cholestatic fibrogenesis in DDC-fed mice; a finding which requires validation in additional models.

Care needs of patients with chronic wounds for implementing a virtual care program: A qualitative study

by Nasib Babaei, Vahid Zamanzadeh, Leila Valizadeh, Mojgan Lotfi, Marziyeh Avazeh

Introduction

Chronic and complex wounds are serious public health problems worldwide. Given the time-consuming nature of chronic wound healing and the need for long-term follow-up, a virtual care approach can effectively manage these patients. Identifying the care needs of patients with chronic wounds is key to successfully managing their care remotely. This study aimed to identify the care needs of patients with chronic wounds for implementing a virtual care program to manage this group of patients remotely.

Methods

This descriptive qualitative study was conducted using a conventional content analysis approach in wound care clinics of East Azerbaijan Province (northwestern Iran). Data were collected through six focus group discussions with wound therapists and six semi-structured individual interviews with patients with chronic wounds. Participants were recruited using purposive sampling. The data were analyzed by MAXQDA 10 software.

Results

After analyzing the data, the most important care needs of patients with chronic wounds for implementing a virtual care program were identified into three main categories, including the need for awareness-raising, needs related to health dimensions, and the need for specialized financial support (insurance).

Conclusion

The findings of this study indicated that the successful implementation of a virtual care program for patients with chronic wounds requires addressing three core needs: enhancing patients’ awareness regarding wound management, attending to their physical, emotional, and social health dimensions, and providing financial support through insurance coverage for wound care services. Addressing these needs can significantly improve the quality of care and therapeutic outcomes for patients in a virtual care setting.

A 28‐Day Ecological Momentary Assessment of Mental Health Among Psychiatric Outpatients With Suicidal Ideation

ABSTRACT

Aims

Considering that suicide has remained a public health challenge in South Korea since 2009, the development of a real-time monitoring system for suicide risk is urgently needed, especially for those living in the community. The aims of this study were to explore the 28-day longitudinal pattern of suicidal ideation, compare momentary depression, anxiety and stress between different risk groups, and identify the association of suicidal ideation with momentary indicators in community-dwelling outpatients at risk of suicide.

Design

Observational and longitudinal investigation.

Methods

A total of 50 community-dwelling psychiatric outpatients were included herein. Those with a history of suicide attempts were classified into the high-risk group (n = 40, 80%), whereas the rest were classified into the low-risk group (n = 10, 20%). Real-time data on depression, anxiety, stress and suicidal ideation were collected from May 2021 to July 2023 based on ecological momentary assessment. Each participant provided reports at least three times a day for 4 weeks. A total of 3195 ecological momentary assessment responses were collected, among which 1345 with the highest mood intensity per day were selected for analysis. Panel mixed-effect linear regression models examined differences in ecological momentary assessment responses between high- and low-risk groups and elucidated the separate effects of depression, anxiety and stress on suicidal ideation in each risk group.

Results

Momentary depression, anxiety and stress were positively associated with momentary suicidal ideation in both risk groups, with these associations being higher among the high-risk group. In both risk groups, momentary suicidal ideation was more strongly associated with momentary depression than with momentary anxiety and stress.

Conclusions

Psychosocial stress indicators were associated with momentary suicidal ideation. Moreover, a strong association was observed between momentary depression and suicide attempts. Further research with larger samples should be conducted to evaluate whether depression interventions could reduce momentary suicidal ideation.

No Patient or Public Contribution.

Assessing the Complexity of Fundamental Care: Developing and Refining the Flinders Fundamentals of Care Assessment Tool for Clinical Practice

ABSTRACT

Aims

To describe the development and refinement of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice through stakeholder feedback. The tool, based on the Fundamentals of Care Framework, supports healthcare leaders and clinicians in assessing fundamental care in a practical and user-friendly manner that embraces rather than minimises the inherent complexity of this care delivery as it occurs in practice.

Design

Multi-method study informed by participatory action principles.

Methods

Data collection involved an anonymous online survey and cognitive interviews with key stakeholders internationally to gauge perspectives on the clarity, usability, and acceptability of the tool. Data were collected between October–December 2023. Quantitative, categorical data were analysed using descriptive statistics. Qualitative data were analysed via content analysis.

Results

Participants described the Tool as Comprehensive, Practical, and Useful. Participants liked the visual representation of results in the form of bar and radar diagrams, which aided in interpreting the outcomes. The main suggestions for improvement were: (1) Simplifying items relating to the ‘Context of Care’ dimension of the Fundamentals of Care Framework; (2) Reducing similarity between some items; (3) Separating or simplifying items with multiple components; and (4) Clarifying terminology.

Conclusion

Based on stakeholder feedback, the Flinders Fundamentals of Care Assessment Tool for Clinical Practice is now digitised and includes a comprehensive instruction manual and definitions for each element of the Fundamentals of Care Framework assessed within the tool. The tool supports healthcare leaders and clinicians to assess fundamental care delivery at multiple levels—individual, team, unit/ward, organisational—identifying areas of strength and improvement to inform decision-making, planning, and quality improvement. The tool offers a way of assessing fundamental care holistically as a multi-dimensional construct rather than as a series of disaggregated tasks, better reflecting and capturing the complex reality of fundamental care delivery.

Implications for the Profession and/or Patient Care

The Flinders Fundamentals of Care Assessment Tool for Clinical Practice supports real-time feedback (i.e., immediate visualisation of results), facilitating its integration in clinical practice to support enhanced fundamental care delivery.

Impact

Seeking stakeholder feedback has enhanced the relevance, acceptability, and feasibility of the Flinders Fundamentals of Care Assessment Tool for Clinical Practice, facilitating its use as a decision-making and planning tool to support improved fundamental care delivery across clinical settings.

Reporting Method

This study is reported using the CROSS and SRQR guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

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