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Hoy — Diciembre 16th 2025Tus fuentes RSS

Microsimulation modelling to predict the burden of CKD and the cost-effectiveness of timely CKD screening in Belgium: results from the Inside CKD study

Por: Vadia · R. · Vandendriessche · E. · Mahieu · E. · Meeus · G. · Van Pottelbergh · G. · Jouret · F. · Retat · L. · Card-Gowers · J. · Jadoul · M. · Vankeirsbilck · A. · Garcia Sanchez · J. J.
Objectives

Inside CKD aims to assess the burden of chronic kidney disease (CKD) and the cost-effectiveness of screening programmes in Belgium.

Design

Microsimulation-based modelling.

Setting

Data derived from national statistics and key literature from Belgium.

Participants

Virtual populations of ≥10 million individuals, representative of Belgian populations of interest, were generated based on published data and cycled through the Inside CKD model. Baseline input data included age, estimated glomerular filtration rate (eGFR), urine albumin-creatinine ratio (UACR) and CKD status.

Primary outcome measures

Outcomes included the clinical and economic burden of CKD during 2022–2027 and the cost-effectiveness of two different CKD screening programmes (one UACR measurement and two eGFR measurements or only two eGFR measurements, followed by renin-angiotensin-aldosterone system inhibitor treatment in newly diagnosed eligible patients). The economic burden estimation included patients diagnosed with CKD stages 3–5; the screening cost-effectiveness estimation included patients aged ≥45 years with no CKD diagnosis and high-risk subgroups (with cardiovascular disease, hypertension, type 2 diabetes or aged ≥65 years).

Results

Between 2022 and 2027, CKD prevalence is estimated to remain stable and substantial at approximately 1.66 million, with 69.9% undiagnosed. The total healthcare cost of patients diagnosed with CKD is expected to remain stable at approximately 2.15 billion per year. The one UACR, two eGFR measurement screening programme was cost-effective in all populations, with an incremental cost-effectiveness ratio of 3623 per quality-adjusted life year (QALY) gained in those aged ≥45 years, well below the estimated willingness-to-pay threshold of 43 839 per QALY gained.

Conclusions

Without changes to current practice, the disease burden of CKD in Belgium is predicted to remain substantial over the next few years. This highlights the need for timely diagnosis of CKD and demonstrates that, in line with guideline recommendations, implementing a CKD screening programme involving UACR and eGFR measurements followed by treatment would be cost-effective.

Efficacy and safety of microbiota-targeted therapeutics in autoimmune and inflammatory rheumatic diseases: protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Kragsnaes · M. S. · Gilbert · B. T. P. · Sofiudottir · B. K. · Rooney · C. M. · Hansen · S. M.-B. · Mauro · D. · Mullish · B. H. · Bergot · A.-S. · Mankia · K. S. · Goel · N. · Bakland · G. · Johnsen · P. H. · Miguens Blanco · J. · Li · S. · Dumas · E. · Lage-Hansen · P. R. · Wagenaar
Introduction

An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.

Methods and analysis

This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.

Ethics and dissemination

No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.

PROSPERO registration number

CRD42025644244.

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Socioeconomic inequality and access to emergency care: understanding the pathways to the emergency department in the UK

Por: Madia · J. · Boyle · A. A. · Ray · J. · Novak · A. · Pope · C. J. · Wheeler · B. · Petrou · S. · Wittenberg · R. · Nicodemo · C.
Objective

To examine how socioeconomic deprivation influences referral pathways to emergency departments (EDs) and to assess how these pathways affect subsequent hospital outcomes.

Design

Retrospective observational study.

Setting

Emergency department of a large teaching hospital in the East of England, providing secondary and tertiary care.

Participants

482 787 ED attendances by patients aged 16 years and over, recorded between January 2019 and December 2023. Patients were assigned Index of Multiple Deprivation (IMD) deciles based on residential postcode.

Main outcome measures

Referral source (general practitioner (GP), National Health Service (NHS) 111, ambulance, self-referral, other), total ED time, 4-hour breach, hospital admission and unplanned return within 72 hours.

Results

Substantial socioeconomic inequalities were observed in referral pathways. Patients from the most deprived areas were significantly less likely to be referred by a GP (4.7%) than those from the least deprived areas (14.7%) and more likely to arrive via ambulance (32% vs 24%). These differences persisted after adjusting for demographic, clinical and contextual variables. Ambulance referrals showed the longest ED stays, ranging from 347 to 351 min across IMD deciles (overall 95% CI 343 to 363) and the highest probability of 4-hour breaches (51%; 95% CI 50% to 53%). Self-referrals had the greatest rates of unplanned returns within 7 days (up to 7.1%; 95% CI 5.5% to 8.7%). In contrast, NHS 111 and GP referrals were associated with shorter stays, lower breach rates and fewer reattendances. Minimal variation in outcomes was observed across deprivation levels once referral source was accounted for.

Conclusions

Inequalities in how patients access emergency care, particularly reduced GP and NHS 111 referrals among more deprived groups, appear to underpin disparities in ED outcomes. Referral source captures important clinical and system-level factors that influence patient experience and resource use. Interventions to improve equitable access to structured referral pathways, particularly in more deprived areas, may enhance both the efficiency and fairness of emergency care delivery. Further research using national data is needed to assess broader policy implications and economic costs associated with differential access.

Palliative care in the education of occupational therapists in Germany: an anonymised cross-sectional survey among trainees and students

Por: Pape · A. E. · Militzer · T. · Schmitt · A. · Vradelis · P. · Volberg · C.
Objectives

The objective of this study is to assess the extent to which palliative care content is integrated into occupational therapy education in Germany. In addition, the study will examine trainees’ and students’ knowledge, experiences and attitudes towards palliative care.

Design

A cross-sectional quantitative survey study using a structured online questionnaire.

Setting

Institutions and universities across Germany that offer training in occupational therapy.

Participants

A total of 451 subjects completed the survey (89.4% female). Of these, 91.4% were trainees at vocational schools, while 8.6% were university students. The inclusion criteria stipulated that subjects must be enrolled in an occupational therapy programme in Germany at the time of data collection.

Interventions

Not applicable.

Primary and secondary outcome measures

The primary outcomes of the study were knowledge, educational experience and attitudes towards palliative care among occupational therapy trainees and students. Secondary outcomes encompassed practical experience with palliative care patients and expressed interest in further training.

Results

A total of 451 occupational therapy trainees and students participated in the survey. The majority of participants (89.4%) were female and in training (91.4%). Although 90.8% had no previous medical training, 69.2% could define palliative care and 92.6% were familiar with the concept of a hospice. However, 68.1% of respondents reported that they had not received any teaching on palliative care as part of their occupational therapy training. A strong interest in further education in this area was expressed by 95.1%. Only 23.9% had practical experience with palliative clients, mainly in nursing homes.

Conclusions

A substantial discrepancy exists between the recognised importance of palliative care and its representation in occupational therapy education. The findings underline the necessity for a more robust and methodical incorporation of palliative care into occupational therapy curricula. This integration is crucial to ensure that trainees and students are adequately equipped with the theoretical knowledge and practical skills necessary to provide support to seriously ill and dying patients.

Trial registration

DRKS00033464.

How can midwives in Germany be supported in advising on early childhood allergy prevention in a health literacy-responsive way? Protocol for a mixed-methods study to co-design and evaluate an educational intervention following the Medical Research Council

Por: von Sommoggy · J. · Steinmann · J. R. · Lander · J. · Bitzer · E. M. · Pawellek · M. · Brandstetter · S. · Apfelbacher · C. · Fillenberg · B. D.
Introduction

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

Methods and analysis

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

Ethics and dissemination

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.

Participants experiences with the Delphi method: an online evaluation of a three-round Delphi across German-speaking countries

Por: Niederberger · M. · Dieudonne · J. · Schifano · J. · Vogt · S.
Objectives

This study evaluates how participants experienced and assessed a three-round Delphi study on the terminology of developmental language disorders in childhood. It compares participants who completed all rounds (completers) with those who withdrew early (dropouts) and aims to derive methodological quality criteria for future Delphi studies.

Design

The evaluation is based on a Delphi study conducted in 2021/2022 across five German-speaking countries. After the final round, n=179 experts (40% response rate) completed a standardised survey assessing their expertise, motivation, reasons for discontinuation, time commitment and perceptions of questionnaire and feedback design. Responses from completers (n=156) and dropouts (n=23) were analysed descriptively.

Results

Most participants had no prior experience with Delphi methods but rated the study positively and considered the topic highly relevant. Completers reported their subjective time commitment to be lower and rated the handling of the questionnaire more positively than dropouts. Feedback was used by nearly half of all experts and was more actively considered by completers. Lack of time was the most common reason for discontinuation.

Conclusion

The findings confirm the feasibility and acceptance of the Delphi method in interdisciplinary health research. In addition to established methodological principles, topic relevance, clear communication and time commitment emerged as key areas for expert motivation and engagement.

Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India

Por: Gerdin Wärnberg · M. · Basak · D. · Berg · J. · Chatterjee · S. · Felländer-Tsai · L. · Ghag · G. · Juillard · C. · Khajanchi · M. · Khan · T. · Mishra · A. · Nandu · V. V. · Roy · N. · Singh · R. · Soni · K. D. · Strömmer · L.
Objective

To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

Design

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Setting

Tertiary care hospitals across metropolitan areas in India.

Participants

Adult trauma patients and residents managing these patients were included.

Interventions

ATLS or PTC training was provided for residents in the intervention arms.

Main outcomes and measures

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Results

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conclusions

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

Trial registration number

NCT05417243.

Surgical and oncological outcomes of right hemicolectomy with complete mesocolic excision in the treatment of right colon cancer: study protocol for a single-centre retrospective cohort study

Por: Nava · C. M. · Najberg · H. · Adamina · M. · Litchinko · A.
Introduction

Complete mesocolic excision (CME) with central vascular ligation (CVL) has been proposed as an oncologically superior surgical technique for right-sided colon cancer, mirroring the impact of total mesorectal excision (TME) in rectal cancer. While promising results have been reported, evidence from routine clinical practice, particularly within Swiss healthcare settings, remains limited. This study aims to evaluate the surgical and oncological outcomes of CME compared with standard right hemicolectomy (non-CME) over a 10-year period.

Methods and analysis

This is a retrospective cohort study of adult patients who underwent right hemicolectomy, either CME or non-CME, for histologically confirmed adenocarcinoma of the right colon or right third of the transverse colon at a tertiary centre, between 2010 and 2020. Patients with concomitant malignancies or distant metastases will be excluded. The primary outcome is 3-year and 5-year disease-free survival. Secondary outcomes include number of harvested lymph nodes, 3-year and 5-year overall survival, and 30-day morbidity.

Ethics and dissemination

This study was approved by the relevant Ethics Committee (CER-VD 2025-00503). All patients provided general consent for secondary use of anonymised data. Results will be submitted to a peer-reviewed journal and presented at national and international conferences.

Exposome project for health and occupational research night shift cohort (EPHOR-NIGHT): a unique resource to advance research on night shift work and chronic disease

Por: Harding · B. N. · Castano-Vinyals · G. · Broberg · K. · Albin · M. · Laurell · C. · Garde · A. H. · Nabe-Nielsen · K. · Fiehn · A. E. S. · van der Grinten · T. · Peters · S. · Vermeulen · R. C. H. · Gosh · M. · Loh · M. · Pronk · A. · Kogevinas · M.
Purpose

The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.

Participant

The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.

Findings to date

From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.

Future plans

A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.

Attitudes towards addressing environmental sustainability in patient-provider interactions: a qualitative study among Dutch physicians

Por: Cohen · E. S. · Grandiek · F. · Kringos · D. S. · Kouwenberg · L. H. J. A. · Sperna Weiland · N. H. · Richie · C. · Aarts · J. W. M. · Hehenkamp · W. J. K.
Objectives

To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.

Design

A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.

Setting

Secondary and tertiary healthcare institutions in the Netherlands.

Participants

Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.

Primary and secondary outcome measures

Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.

Results

The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.

Conclusions

OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.

Physical activity and psychosocial characteristics of individuals with and without chronic low back pain in daily life: protocol for the PRIA intensive longitudinal study

Por: Kolodziejczak-Krupp · K. · Zipper · V. · Wilhelm · L. O. · Thiel · L. · Stein · C. · Schäfer · T. · Pumberger · M. · Schmidt · H. · Fleig · L.
Introduction

Despite the high prevalence of chronic low back pain (cLBP), its underlying mechanisms remain poorly understood. Addressing modifiable psychosocial resources and health behaviours such as physical activity offers a promising avenue for reducing the impact of cLBP. Furthermore, although the relationship between physical activity and pain is theorised as a within-person process, previous research has primarily focused on between-person differences. In this article, we present the protocol for the prospective observational study PRIA (Psychologie und Rückengesundheit im Alltag), which is part of a larger interdisciplinary research consortium investigating preventive, diagnostic and therapeutic aspects of cLBP. Drawing on theories from health and pain psychology, the outlined study examines the interplay between different dimensions of cLBP and back health, physical activity and their psychosocial determinants within individuals in their everyday lives.

Methods and analysis

This prospective longitudinal study combines online questionnaires with ecological momentary assessment of health behaviours, cognitions, affect, social support and pain using a smartphone-based app (movisensXS) and continuous measurement of physical activity by accelerometry (movisens Move 4). Parameters will be recorded at baseline (T0), daily for the following 14 days (five times per day at 09:00, 12:00, 15:00, 18:00 and 21:00, resulting in up to 70 measurement occasions), 3 and 6 months later (T1 and T2). A total of 230 participants (115 individuals with cLBP and 115 without cLBP) aged 18–64 years will be enrolled. The associations between cLBP and the measured parameters will be examined using multilevel models.

Ethics and dissemination

The university’s ethics committee at the MSB Medical School Berlin approved the study on 8 March 2021 (approval number MSB-2021/59, amendment approved on 10 November 2023, amendment number MSB-2023/145). Ethical approval for the FOR 5177 initial screening was granted by Charité – Universitätsmedizin Berlin (EA1/058/21). All participants provided written informed consent. The results of this research will be published in peer-reviewed international journals, presented at national and international conferences, and reported to the German Research Foundation.

Trial registration number

DRKS00032978.

Diet and diet-related challenges with specific focus on carbohydrates and carbohydrate counting in adults with type 1 diabetes: a cross-sectional study

Por: Sterner Isaksson · S. · Hellman · J. · Wijkman · M. · Imberg · H. · Olafsdottir · A. F. · Axelsen · M. · Lind · M.
Objectives

To explore dietary intake, diet-related challenges in glucose management and perceived needs for dietary support among Swedish adults with type 1 diabetes (T1D).

Design

Cross-sectional observational study based on an electronic survey that included the validated Meal-Q food frequency questionnaire and additional questions on dietary habits and management. Participant characteristics were retrieved from the Swedish National Diabetes Register. Descriptive and correlation analyses were conducted.

Setting

Three diabetes specialist clinics in Sweden.

Participants

375 adults with T1D.

Main outcome measures

Dietary intake and diet-related challenges in glucose management.

Results

A total of 191 persons (mean age 48 years; 48% female) consented to participate. The mean (SD) glycated haemoglobin A1c was 56 (13) mmol/mol, mean glucose 8.8 (2.2) mmol/L, time in range (TIR) 64% (18%) and BMI 27 (4.3) kg/m²; 41% used insulin pumps. Mean carbohydrate intake was 183 g/day (41% of energy, E%). Fibre intake was 23 g/day (3.1 g/MJ), and saturated fat intake was 29 g/day (15 E%), both inconsistent with dietary recommendations. About half (51%) found carbohydrate counting challenging, with 53% estimating carbohydrate intake visually and only 18% using advanced methods. Additionally, 48% reported reducing carbohydrate intake, and 61% avoided certain carbohydrate-rich foods due to glucose management difficulties. Approximately 40% of participants reported insufficient dietary guidance from their healthcare providers since diagnosis, 33% expressed interest in further dietitian support and 39% believed dietary changes could improve glucose control.

Conclusions

Participants reported lower fibre intake and higher saturated fat intake compared with dietary guidelines. Many found carbohydrate counting and carbohydrate-rich meals challenging. One-third expressed a wish for additional dietary support. These findings highlight the importance of improving access to tailored dietary counselling in routine T1D care.

Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy--Px7 The study protocol of a multicentre binational randomised controlled trial

Por: Agache · A. · Deding · U. · Kaalby · L. · Kobaek-Larsen · M. · Al-Najami · I. · Ostergaard Hansen · L. · Stryhn · C. · Wilde · D. · Forsberg · A. · Backman · A.-S. · Bates · T. · de Lange · T. · Martling · A. · Baatrup · G.
Introduction

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

Methods and analysis

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Ethics and dissemination

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

Trial registration number

NCT06335420.

Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory)

Por: Pop-Busui · R. · Petersen · E. A. · Levy · B. L. · Tesfaye · S. · Armstrong · D. G. · Grunberger · G. · Boulton · A. J. · Bharara · M. · Edgar · D. · Azalde · R. P. · Caraway · D.
Introduction

Current pharmacological treatment options for painful diabetic neuropathy (PDN) often fail to provide adequate pain relief. However, in the recent SENZA-PDN study, high-frequency 10 kHz spinal cord stimulation (SCS) demonstrated significant long-term improvements in lower limb pain and health-related quality of life (HRQoL) in a PDN population. Furthermore, more than half of 10 kHz SCS recipients showed improved sensory function based on non-blinded clinical assessments in post hoc analysis. We report the design of the PDN-Sensory study, which aims to evaluate changes in pain and neurological function with 10 kHz SCS in the treatment of PDN. The study will include objective measures of neurological function, including the modified Toronto Clinical Neuropathy Score (mTCNS) and intraepidermal nerve fibre density (IENFD).

Methods and analysis

This multicentre, prospective, randomised controlled trial will compare conventional medical management (CMM) with 10 kHz SCS+CMM in individuals with diabetes and chronic, intractable lower limb pain due to PDN. Participants will be randomised 1:1 to CMM alone or 10 kHz SCS+CMM, with optional crossover at 6 months. The primary outcome is the proportion of participants at 6 months achieving ≥50% pain relief from baseline. The key secondary endpoint is the proportion of participants at 6 months with a reduction in mTCNS of ≥3 points from baseline (excluding changes in foot pain). Additional endpoints at 6 and 12 months include changes from baseline in mTCNS, IENFD, 7-day averaged pain score, pain-related interference, HRQoL, sleep, psychological outcomes, functional status and metabolic parameters.

Ethics and dissemination

The study protocol received central approval from the Western Institutional Review Board (IRB #20230954). Local IRB approval will be required before initiation of the study at each participating clinical site. The study complies with Good Clinical Practice guidelines (ISO 14155), the Declaration of Helsinki, and all applicable national, federal and local regulatory requirements. Dissemination plans include presentations at national and international conferences and publication in a peer-reviewed journal with open access.

Trial registration number

NCT05777317.

Use of physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion (ULTRA-CTO): protocol for a prospective, single-arm, multicentre, exploratory study

Por: Griffioen · A. M. · Meijers · T. A. · Roolvink · V. · van der Heijden · D. J. · Volleberg · R. H. J. A. · van Wely · M. · van Royen · N. · van Geuns · R.-J. · van Leeuwen · M.
Introduction

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

Methods and analysis

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

Ethics and dissemination

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

Study registration

NCT04780971.

Hormonal contraception and the risk of suicidal behaviour: a Swedish nationwide register-based study

Por: Aleknaviciute · J. · Lu · D. · Gotby · V. · Frans · E. M. · Kuja-Halkola · R. · Engberg · H. · Tiemeier · H. · Lichtenstein · P. · Fang · F. · Kushner · S. A. · Chang · Z.
Objectives

To determine whether hormonal contraceptives are associated with subsequent risks of suicidal behaviour and depression among women of reproductive age.

Design

Nationwide register-based study.

Setting

Swedish national population using health and death registers. Nationwide registries provided individual-level information about the use of hormonal contraception, suicidal behaviour, depression and potential confounders.

Participants

All women in Sweden from 1 January 2006 to 31 December 2013.

Outcomes measures

Suicidal behaviour events or registered deaths due to suicide were identified through the National Patient Register and Cause of Death Register, respectively. Clinical diagnoses of depression were obtained from the patient register. Cox regression models were used to estimate HRs with 95% CIs of suicidal behaviour and depression in women using hormonal contraceptives.

Results

We followed more than two million women for a median of 6.8 years (12.4 million person-years in total). No increased risk was observed among women using oral contraceptives or non-oral combined oestrogen/progestin formulations. Non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour using both population-based (HR=1.17, 95% CI 1.13 to 1.21) and within-individual (HR=1.16, 95% CI 1.11 to 1.21) analyses. Age-stratified analyses revealed that during late adolescence (age 15–18), use of oral contraceptives or non-oral combined formulations was associated with an increased risk of suicidal behaviour (range of HRs: 1.09–1.35), an effect that was not observed in adulthood. In contrast, non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour during both late adolescence and adulthood.

Conclusions

We found no overall increased risk of suicidal behaviour among women using oral contraceptives or non-oral combined formulations. However, the observed increased risk associated with hormonal contraceptive use during adolescence, as well as with non-oral progestin-only contraception—particularly gonane-containing formulations—across the entire reproductive window warrants attention and further investigation.

Short- and long-term complications after slowly resorbable biosynthetic P4HB mesh (Phasix) implantation in European centres: a protocol paper for a multiregistry study

Background

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.

Methods and analysis

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.

Ethics and dissemination

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.

Timely Implementation of Patient‐Reported Outcomes in Clinical Care: Insights From Clinicians and Health Informatics Experts

ABSTRACT

Aim

To explore the optimal timing of patient-reported outcome assessment, defined as the collection and use of patient-reported outcomes at clinically meaningful points such as before or during encounters, treatment initiation and follow-up, and to identify the facilitators and barriers to timely use.

Design

A qualitative analysis of semi-structured interviews with healthcare professionals across diverse US health systems.

Methods

Thematic analysis was used to identify key themes related to the timing and implementation of patient-reported outcomes assessments. Interviews were analysed iteratively to develop a coding framework and synthesise overarching themes.

Results

Fourteen healthcare professionals, including nurse practitioners, cardiologists and health informatics experts across seven U.S. health systems from academic and community hospitals, were interviewed in February 2024. Three major themes emerged: (1) value proposition of timely patient-reported outcome data collection (2) key facilitators for timely implementation and (3) multilevel barriers. The value proposition focused on the use of patient-reported outcomes for prevention and active disease management. Critical facilitators for the timely implementation of patient-reported outcomes included the involvement of research and clinical coordinators, strategies for pre-visit and on-site patient-reported outcome collection, the use of standardised templates within EHRs and the alignment of patient-reported outcome collection with patients' long-term treatment goals. Finally, multilevel barriers included time constraints, patient-level challenges (e.g., fatigue, literacy, language) and systemic issues (e.g., technical limitations, lack of reimbursement and unclear guidelines).

Conclusion

Timely collection and use of patient-reported outcomes is critical for improving symptom monitoring and supporting patient-centered clinical decision-making. However, multilevel barriers hinder consistent implementation across health care settings.

Implications for the Profession and/or Patient Care

Integrating patient-reported outcomes into clinical workflows can improve the patient-centeredness of patient-healthcare professional interactions, and provide a more holistic picture of a patient's health status. Addressing barriers to patient-reported outcome implementation, including lack of time, poor health literacy and workflow integration barriers, is crucial for improving clinical outcomes.

Reporting Method

This study adhered to the COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist, in accordance with EQUATOR Network guidelines.

Patient or Public Contribution

No patient or public involvement: This study did not include patient or public involvement in its design, conduct or reporting.

Influence of subnational contextual factors on demand for family planning satisfied by modern methods: a multilevel approach in 46 surveys from low- and middle-income countries

Por: Lima · N. P. · Blumenberg · C. · Hellwig · F. · Barros · A. J. D. · Wehrmeister · F. C.
Objectives

Understanding contextual drivers of family planning is crucial for designing effective, context-specific policies and programmes. This study aimed to assess (1) the extent to which province-level contextual factors are associated with both coverage and wealth-related inequalities in demand for family planning satisfied by modern methods (mDFPS) across provinces in low- and middle-income countries (LMICs), and (2) whether these factors influence mDFPS at women’s level.

Design

Observational study using multilevel modelling at both ecological and individual levels.

Setting

We analysed data from Demographic and Health Surveys between 2011 and 2022 in 46 LMICs.

Participants

Ecological analysis included 621 provinces. Individual-level analysis included 302 493 women aged 15–49 years, currently married or in union, and in need of contraception (unweighted).

Primary and secondary outcome measures

Demand for family planning satisfied by modern methods (mDFPS) and wealth-related inequalities in mDFPS, assessed using the slope index of inequality (SII) and the concentration index (CIX).

Results

In both income groups, at the province level, higher mean women’s schooling and greater proportion of employed women were positively associated with mDFPS coverage. In contrast, higher male-to-female educational attainment ratios were inversely associated with mDFPS. Provinces with higher means of women’s schooling also showed lower wealth-related inequalities in mDFPS. At the individual level, women residing in provinces with higher male-to-female educational attainment ratios were found to have lower odds of mDFPS, regardless of the income group. Additionally, the factors influencing individual women’s mDFPS varied depending on the income level of the country’s provinces.

Conclusion

Women’s empowerment and gender equality in education at the province level significantly influence family planning outcomes. Targeted interventions that address each region’s specific educational, economic and demographic contexts are crucial for improving coverage and reducing disparities in family planning services.

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