FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerInterdisciplinares

Midlife and old-age cardiovascular risk factors, educational attainment, and cognition at 90-years – population-based study with 48-years of follow-up

by Anni Varjonen, Toni Saari, Sari Aaltonen, Teemu Palviainen, Mia Urjansson, Paula Iso-Markku, Jaakko Kaprio, Eero Vuoksimaa

We examined the associations of midlife and old-age cardiovascular risk factors, education, and midlife dementia risk scores with cognition at 90 + years, using data from a population-based study with 48 years of follow-up. Participants were 96 individuals aged 90–97 from the older Finnish Twin Cohort study. Individual cardiovascular risk factors assessed via questionnaires in 1975, 1981, 1990, and 2021–2023 included blood pressure, body mass index, physical activity, and cholesterol, and self-reported educational attainment. The Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) score and an educational-occupational attainment score were used as midlife dementia risk scores. Cognitive assessments included semantic fluency, immediate and delayed recall from a 10-word list learning task, and a composite cognitive score. Regression analyses were conducted with dementia risk factors predicting cognition at 90 + years, adjusting for age, sex, education, follow-up time, and apolipoprotein E genotype (ε4-carrier vs non-carriers). Results showed that higher education and higher educational-occupational score were associated with better cognitive performance in all cognitive measures. Those with high midlife blood pressure scored significantly higher in all cognitive tests than those with normal blood pressure. Conversely, those with high old-age blood pressure scored lower in semantic fluency and composite cognitive score, but not in immediate or delayed recall. Other cardiovascular risk factors and the CAIDE score did not show consistent associations with cognition. Education appears to have a long-lasting protective effect in cognitive aging, whereas midlife and old-age cardiovascular risk factors were not significantly associated with cognition at 90 + years.

A Borate‐Based Bioactive Glass Advances Wound Healing in Non‐Healing Wagner Grade 1 Diabetic Foot Ulcers: A Randomised Controlled Clinical Trial

ABSTRACT

A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.

Development of intersectoral medical care for patients with 'chronic critical illness: protocol for a telemedicine interventional study with a pre-post design in out-of-hospital intensive care facilities (E=MC{superscript 2})

Por: Edel · A. · Jöbges · S. · Weiss · B. · Paul · N. · Lyall · M. L. · Hoffmann · C. · Schüürhuis · S. · Piper · S. K. K. · Konietschke · F. · Berger · E. · Busse · R. · Marschall · U. · Kraufmann · B. · Witzenrath · M. · Eckardt · K.-U. · Spies · C.
Introduction

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

Method and analysis

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

Ethics and dissemination

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

Trial registration number

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial

Por: Rocliffe · P. · Whiston · A. · O Mahony · A. · OReilly · S. M. · OConnor · M. · Cunningham · N. · Glynn · L. · Walsh · J. C. · Walsh · C. · Hennessy · E. · Murphy · E. · Hunter · A. · Butler · M. · Paul · L. · Fitzsimons · C. F. · Richardson · I. · Bradley · J. G. · Salsberg · J. · Hayes
Introduction

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Methods and analysis

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethics and dissemination

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Factors associated with prolonged hospitalizations for COVID-19 during the first three waves of the pandemic: Evidence from a Southeastern State of Brazil

by Juliana Rodrigues Tovar Garbin, Franciéle Marabotti Costa Leite, Ana Paula Brioschi dos Santos, Larissa Soares Dell’Antonio, Cristiano Soares da Silva Dell’Antonio, Luís Carlos Lopes-Júnior

A comprehensive understanding of the factors influencing the epidemiological dynamics of COVID-19 across the pandemic waves—particularly in terms of disease severity and mortality—is critical for optimizing healthcare services and prioritizing high-risk populations. Here we aim to analyze the factors associated with short-term and prolonged hospitalization for COVID-19 during the first three pandemic waves. We conducted a retrospective observational study using data from individuals reported in the e-SUS-VS system who were hospitalized for COVID-19 in a state in a southeast state of Brazil. Hospitalization duration was classified as short or prolonged based on a 7-day cutoff, corresponding to the median length of hospital stay during the second pandemic wave. Bivariate analyses were performed using the chi-square test for heterogeneity. Logistic regression models were used to estimate odds ratios (ORs) and their respective 95% confidence intervals (CIs), with statistical significance set at 5%. When analyzing hospitalization duration across the three waves, we found that 51.1% (95%CI: 49.3–53) of hospitalizations in the first wave were prolonged. In contrast, short-duration hospitalizations predominated in the second (54.7%; 95% CI: 52.4–57.0) and third (51.7%; 95% CI: 50.2–53.2) waves. Factors associated with prolonged hospitalization varied by wave. During the first wave, older adults (≥60 years) (OR=1.67; 95%CI: 1.35–2.06), individuals with ≥10 symptoms (OR=2.03; 95%CI: 1.04–3.94), obese individuals (OR=2.0; 95%CI: 1.53–2.74), and those with ≥2 comorbidities (OR=2.22; 95%CI: 1.71–2.89) were more likely to experience prolonged hospitalization. In the second wave, he likelihood of extended hospital stays was higher among individuals aged ≥60 years (OR=2.04; 95%CI: 1.58–2.62) and those with ≥2 comorbidities (OR=1.77; 95%CI: 1.29–2.41). In the third wave, prolonged hospitalization was more frequent among older adults (OR=1.89; 95%CI: 1.65–2.17,), individuals with 5–9 symptoms (OR=1.52; 95%CI: 1.20–1.92), obese individuals (OR=2.2; 95%CI: 1.78–2.73), and those with comorbidities (OR=1.45; 95%CI: 1.22–1.72 and OR=2.0; 95%CI: 1.69–2.45). In conclusion, we identified variations in hospitalization patterns across the pandemic waves, although the differences were relatively subtle. These variations likely reflect gradual shifts in the risk factors associated with prolonged hospital stays. Our findings highlight t the importance of implementing targeted public health interventions, particularly those designed to reduce disease severity and improve clinical outcomes among vulnerable populations at greater risk of extended hospitalization.

Consensus on the definition, components, timeframe and grading of composite outcome of postoperative pulmonary complication--protocol for an international mixed-method consensus study (PrECiSIOn)

Por: Nasa · P. · Yurttas · T. · Battaglini · D. · Blot · S. · Fernandez-Bustamante · A. · Gama de Abreu · M. · van Meenen · D. M. · Myatra · S. N. · Serpa Neto · A. · Oppong · R. · Paulus · F. · Renukappa · S. · Schultz · M. J. · Slutsky · A. S. · Hemmes · S. N. T. · for the PrECiSIOn-gro
Introduction

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

Methods

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Analysis

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by 2 tests or the Kruskal-Wallis test.

Ethics and dissemination

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

Trial registration number

NCT06916598 (clinicaltrials.gov).

Food insecurity and dietary intakes as correlates of anxiety and depression in underserved settlements in Khulna Division of Bangladesh: a developing country perspective

Por: Shuvo · S. D. · Mandal · A. C. · Khanum · L. · Bashar · M. A. · Roy · D. · Paul · D. K.
Objective

This study aimed to investigate the association between food insecurity and dietary intake with anxiety and depression among residents of underserved urban settlements in Bangladesh.

Design

This cross-sectional study was used to collect data from participants through face-to-face interviews using structured questionnaires. Food security status was assessed using the Household Food Insecurity Access Scale, while anxiety and depression levels were measured using the Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9, respectively. Dietary intake was evaluated through a 24-hour dietary recall and Food Frequency Questionnaire method.

Setting

Five districts located within the Khulna Division of Bangladesh.

Participants

Residents of underserved urban areas in Bangladesh (n=749), aged ≥18 years old.

Results

Results indicated that 22.1%, 74.6% and 44.5% of participants experienced severe food insecurity, mild to moderate food insecurity and low Household Dietary Diversity Score, with a significant portion also showing symptoms of anxiety (57.1%) and depression (57.9%). Food insecurity and Household Dietary Diversity Score were found to be positively associated with both anxiety (p

Conclusion

These findings highlight that food insecurity not only affects dietary habits but also exacerbates mental health outcomes. Addressing food insecurity and balanced dietary intake could therefore contribute to better mental health outcomes and overall well-being in underserved communities. Policymakers should prioritise comprehensive strategies that ensure access to nutritious foods and provide mental health support to vulnerable groups.

Noradrenaline for progressive supranuclear palsy syndromes (NORAPS): a randomised, double-blind, placebo-controlled, crossover Phase IIb clinical trial evaluating the efficacy and safety of oral atomoxetine for treating cognitive and behavioural changes i

Por: Durcan · R. · Paula · H. · Ghosh · B. C. P. · Street · D. · High · J. · McAlister · C. · Shepstone · L. · Russell · C. · Grant · K. · Igosheva · N. · Rodgers · C. T. · Jones · S. P. · Ye · R. · Kobylecki · C. · Church · A. · Antoniades · C. · Marshall · V. · Passamonti · L. · Rowe · J. B.
Introduction

Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.

Methods and analysis

Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.

Ethics and dissemination

The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.

Trial registration number

ISRCTN99462035; DOI: https://doi.org/10.1186/ISRCTN99462035; EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)/CTIS (Clinical Trial Information System) number: 2019-004472-19; IRAS (Integrated Research Application System) number: 272063; Secondary identifying numbers: CPMS (Central Portfolio Management System) 44441.

Diversity, distribution, and population structure of <i>Escherichia coli</i> in the lower gastrointestinal tract of humans

by Rasel Barua, Paul Pavli, David Gordon, Claire O’Brien

Several studies report the diversity, and population structure of Escherichia coli (E. coli) in the human gut, but most used faecal specimens as the source of E. coli for analysis. In the present study, we collected mucosal biopsies from three different locations: the terminal ileum, transverse colon, and rectum from 46 individuals. To identify unique strains, we fingerprinted about 3300 isolates of E. coli via the multiple-locus variable-number tandem-repeat analysis (MLVA) technique. An example of each strain per individual then underwent PCR for phylogrouping, and specific phylogrouped strains were further screened to determine whether they belonged to one of four common human-associated sequence types (ST69, ST73, ST95, and ST131), and to identify B2-subtypes. We detected on average 2.5 unique strains per individual. The frequency of unique strain(s) appeared in individuals as follows: 35% (16/46) had only one strain, 22% (10/46) had two strains, 24% (11/46) had three strains and 4% (2/46), 9% (4/46) and 7% (3/46) had 4, 5 and 6 strains, respectively. Strain richness did not depend on gender, age, or disease status. The most abundant phylogroup in all gut locations was B2 followed by A, B1, and D. Strain richness overall and across gut locations was decreased if an individual’s dominant strain belonged to phylogroup B2. ST95, ST131, and ST73 constituted more than half of the total B2 strains. Analysis of B2 sub-types revealed that sub-types IX (STc95) and I (STc131) were more common than other sub-types. The phylogroup and ST of strains at different gut locations did not vary significantly. However, there were multiple examples of individuals who carried strains detected only in one gut location. The present study suggests that particular phylogroups and STs are likely to dominate in different locations in the lower gut of humans.

Weighted Hypoxemia Index: An adaptable method for quantifying hypoxemia severity

by Diane C. Lim, Cheng-Bang Chen, Ankita Paul, Yujie Wang, Jinyoung Kim, Soonhyun Yook, Emily Y. Kim, Edison Q. Kim, Anup Das, Medhi Wangpaichitr, Virend K. Somers, Chi Hang Lee, Phyllis C. Zee, Toshihiro Imamura, Hosung Kim

Objective

To quantitate hypoxemia severity.

Methods

We developed the Weighted Hypoxemia Index to be adapted to different clinical settings by applying 5 steps to the oxygen saturation curve: (1) Identify desaturation/resaturation event i by setting the upper threshold; (2) Exclude events as artifact by setting a lower threshold; (3) Calculate weighted area for each i, as (Δi × Φi); (4) Calculate a normalization factor Ω for each subject; (5) Calculate the Weighted Hypoxemia Index as the summation of all weighted areas multiplied by Ω. We assessed the Weighted Hypoxemia Index predictive value for all-cause mortality and cardiovascular mortality using the Sleep Heart Health Study (enrollment 1995–1998, 11.1 years mean follow-up).

Results

We set varying upper thresholds at 92%, 90%, 88%, and 86%, a lower threshold of 50%, calculated area under the curve and area above the curve, with and without a linear weighted factor (duration of each event i), and used the same normalization factor of total sleep time Conclusion

The Weighted Hypoxemia Index offers a versatile and clinically relevant method for quantifying hypoxemia severity, with potential applications to evaluate mechanisms and outcomes across various patient populations.

Work ability during the COVID-19 pandemic: A cross-sectional study in a low-income urban setting in Brazil

by Ana Paula Cândido Oliveira, Daniela Alencar Vieira, Cristiane Wanderley Cardoso, Tereza Magalhães, Rosangela Oliveira Anjos, Eduardo José Farias Borges Reis, Kionna Oliveira Bernardes Santos, Guilherme Sousa Ribeiro

Work ability is a subjective concept that reflects the balance between an individual’s perception of the physical, mental, and social demands of work and their competence and resources to meet those demands. The COVID-19 crisis significantly impacted health, work, and socioeconomic conditions worldwide. However, few studies have examined work ability in disadvantaged urban communities during this period. To analyze factors associated with work ability within the context of social vulnerability during the COVID-19 pandemic, we conducted a cross-sectional study in a low-income neighborhood in Salvador, Brazil, between February and June 2022. Sociodemographic, health, and labor data were collected, and work ability was assessed using the Work Ability Index (WAI), a widely used tool for evaluating work ability. Multivariable analyses based on a hierarchical model were run to investigate factors associated with low WAI scores. The study included 292 workers aged ≥16 years (59.6% women; median age 41 years). Most workers (84.6%) were classified as having adequate work ability based on their WAI scores. Multivariable analyses found that inadequate work ability was more frequent among women (prevalence ratio [PR]: 1.89, 95% confidence interval [CI]: 1.02-3.48), individuals who self-rated their health as moderate/good (PR: 5.91; 95% CI: 1.45-24.05) or poor/very poor (PR: 21.62; 95% CI: 5.14-90.91) compared to those with excellent/very good health, and those reporting diabetes (PR: 2.1; 95% CI: 1.13-3.9). Working >40 hours per week (PR: 0.47; 95% CI: 0.28-0.96) was negatively associated with inadequate work ability, suggesting that individuals with adequate work ability may be selected for longer working hours. A history of COVID-19 was not associated with inadequate work ability. These findings suggest that targeted interventions to improve work ability in low-income communities should prioritize women and workers with chronic health conditions, such as diabetes.

Understanding preconception care: a scoping review of knowledge, attitudes and practices among reproductive age individuals, healthcare workers and stakeholders in low- and middle-income countries

Por: Aynalem · Y. A. · Paul · P. · Kung · J. Y. · Hussain · A. · Lassi · Z. · Meherali · S.
Objectives

This scoping review aims to map existing evidence on knowledge, attitudes and practices (KAP) and barriers to preconception care in low- and middle-income countries. The primary objective is to identify key gaps and research priorities to guide future efforts to improve maternal and child health.

Design

This review followed Arksey and O'Malley’s scoping review framework, with a comprehensive search across Medline, EMBASE, CINAHL and Scopus from inception to May 2025. Eligible studies included original research on preconception care (PCC), KAP in low- and middle-income countries (LMICs) without date restrictions. Two independent reviewers conducted screening in Covidence. Findings were presented in graphical, tabular and narrative formats, adhering to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols Extension for Scoping Reviews (PRISMA-ScR) standard.

Setting

The review focused on PCC studies conducted in LMICs across various healthcare settings, emphasising primary and secondary levels of care. The geographical scope was global but limited to LMICs as defined by World Bank criteria.

Result

A total of 62 studies were included in the review. Of these, 42 employed quantitative methods, 18 used qualitative approaches and 2 used a mixed-methods design. Regarding focus areas, 25 studies assessed knowledge, 14 assessed practices, 12 studies assessed KAP comprehensively and 10 assessed attitudes. Participants were mainly women of reproductive age (44 studies), with only five studies including men. Among healthcare providers, KAP varied, with midwives being the most frequently studied group. Stakeholders such as policymakers were notably under-represented. Identified barriers included limited training, cultural beliefs and inadequate policies. Facilitators highlighted were targeted education, spousal support and policy advocacy, emphasising the need for gender-sensitive and systemic interventions.

Conclusion

LMICs face complex challenges in utilising PCC, influenced by socioeconomic, cultural, and healthcare system factors. To address these challenges, nuanced approaches incorporating intersectional perspectives and practical qualitative methodologies are essential for improving couples' and child health outcomes.

Trial registration number

The study protocol was registered in the Open Science Framework (OSF) on December 23, 2022, with DOI: 10.17605/OSF.IO/H3MK6.

Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol

Por: Petersen Williams · P. · Huddlestone · L. · Shoesmith · E. · Brady · S. · Mitchell · A. · Exley · V. · Wiggins · F. · Sinclair · L. · Pervin · J. · Horspool · M. · Leahy · M. · Paul · C. · Colley · L. · Shahab · L. · Watson · J. · Hewitt · C. · Hough · S. · Britton · J. · Coleman · T. · Gilb
Introduction

Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis

This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination

Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number

ISRCTN77855199.

Effectiveness of methadone versus buprenorphine in the treatment of opioid use disorder: secondary analyses of prospective cohort study data

Por: Naji · L. · Rosic · T. · Dennis · B. · Worster · A. · Paul · J. · Thabane · L. · Samaan · Z.
Objectives

To compare the effectiveness of buprenorphine-naloxone (bup/nal) and methadone maintenance therapy (MMT) in the treatment of patients with opioid use disorder (OUD) during the fentanyl era.

Design

Secondary analysis of prospective cohort study data.

Setting

Data for the study were collected from 54 clinical sites across Ontario, Canada, between May 2018 and January 2023.

Participants

To be included in the present study, participants had to be at least 16 years of age, have provided written informed consent and be receiving either MMT or bup/nal therapy for OUD. This study includes data from 2601 participants, of whom 2068 were receiving MMT and 533 were receiving bup/nal for OUD. The mean age of participants was 39.4 years (SD: 10.9), and 45% were female.

Interventions

MMT or bup/nal treatment for OUD.

Outcome measures

We employed a propensity score matched analysis to compare treatment outcomes among patients receiving MMT compared with bup/nal. We used ongoing illicit opioid use as an indicator of treatment outcome. We considered participants with >50% of urine drug screens in the past 12 months positive for non-prescribed opioids to be ‘non-responders’. We conducted subgroup analyses to identify whether treatment type was associated with ongoing non-prescribed opioid use among patients with and without a history of intravenous drug use (IVDU), and whether treatment type was associated with retention in treatment.

Results

Eight per cent of patients on bup/nal were considered non-responders, compared with 11.9% of patients on MMT. We did not find a statistically significant association between treatment type and treatment response. However, we did find that patients on MMT were more likely to stay in treatment for 12 months (OR 1.79, 95% CI 1.45 to 2.22, p

Conclusions

Among a cohort of patients with OUD receiving treatment during the fentanyl era, we find that there is no statistically significant difference in ongoing non-prescribed opioid use between patients receiving MMT compared with bup/nal. Future studies should aim to further compare treatment effectiveness using patient-centred outcomes and pragmatic trial designs.

Comprehensive Geriatric Assessment in primary healthcare: a scoping review protocol

Por: Vidinha Pereira · A. L. · Vaz · A. · Paul · C. · Santiago · L. · Rosendo · I.
Objectives

To compile and compare the Comprehensive Geriatric Assessment (CGA) models that exist worldwide and their applicability in primary healthcare (PHC).

Introduction

The world’s population is ageing rapidly, but health systems are slow to keep up with this trend, making it difficult to provide care for older adults. The broad concept of frailty has prompted a comprehensive and holistic approach to patients, where the assessment is related not only to functional, physical and cognitive abilities of the older adults, but also their social, environmental and economic context. In recent decades, the approach to frailty has taken the CGA as the gold standard. With this project, we intend to carry out a scoping review to identify and describe tools to help standardise and generalise CGA in PHC.

Inclusion criteria

Individuals aged 65 years or over; CGA in a PHC setting; the CGA methods reported must include at least three domains: physical, cognitive and social; Articles without language restrictions; Articles published in the last 30 years.

Methods

All studies that refer to CGA models and fulfil the inclusion criteria will be selected. A bibliographic search of articles will be carried out using the following electronic scientific publication databases: MEDLINE-PubMed, Embase, Cochrane Library and Web of Science. We will search for grey literature on sites such as ‘OpenGrey’ and thesis repositories such as RCAAP, EBSCO and EThOS, as well as on the WHO pages. The articles will be independently selected by two reviewers, and the data will be presented in narrative format, structured according to the objective, focus and question of the review.

Ethics and dissemination

Approved by the ethics committee of the regional health administration of the centre, registered as Project 11/2024 and approved on 8 May 2024. The findings of this study will be disseminated through peer-reviewed publications and national or international conference presentations. Updates of the review will be conducted, as necessary.

Trial registration number

Open Science (DOI 10.17605/OSF.IO/REH43).

A Randomised Cross‐Over Study to Evaluate the Physiological Effects of Internal Air Pressure Changes in Advanced Support Surface Design

ABSTRACT

High specification mattresses periodically redistribute pressure using alternating air cells, offloading tissues. This study aimed to evaluate the effects of alternating air pressure gradients on sacral tissue physiology. This randomised cross-over study recruited 15 healthy participants to test the three mattress settings (fast cycle, normal cycle, and slow cycle). Participants were asked to adopt supine, lateral, and high sitting (head of bed at 40°) postures, whilst transcutaneous tissue gas tensions and interface pressures at the sacrum were continuously monitored. Comparison between mattress settings and postures showed no statistical difference (p > 0.05) between peak pressure index values at the sacrum for each air inflation cycle speed setting. By contrast, a significantly higher sacral (p < 0.05) contact area was observed for high sitting. During high sitting, ischemic responses during both fast and normal air inflation cycle speed settings were recorded. During the slow air inflation cycle speed, most participants (60%–100%) showed high levels of perfusion. The present study identified a main effect of posture on interface pressure and perfusion over the sacrum. The alternating mattress speed influenced local tissue perfusion, with the greatest changes in tissue oxygenation occurring in a high-speed setting.

A Clinical Decision Support Tool for the Management of Diabetes‐Related Foot Ulcers (DRFUs) Using a Topical Haemoglobin Spray

ABSTRACT

Diabetes related foot ulcers (DFUs) are complex and costly to manage, with the prevalence of non-healing wounds steadily increasing across the globe. Non-healing wounds can occur when clinicians fail to undertake an appropriate assessment, fail to recognise the importance of systemic or local complications, or provide the optimal treatment. The aetiological causes behind non-healing wounds are multifactorial; however, the purpose of this article is to focus on the role of oxygen in non-healing wounds and to introduce readers to advances in the delivery of topical oxygen therapy (TOT) via a haemoglobin spray. Importantly, this article incorporates a clinical decision support tool (CDST) to help clinicians identify the most appropriate individuals for whom topical haemoglobin may be most beneficial and the most appropriate time for introducing the intervention to improve wound healing outcomes.

Linear and Area Coverage With Closed Incision Negative Pressure Therapy Management: International Multidisciplinary Consensus Recommendations

ABSTRACT

Closed incision negative pressure therapy (ciNPT) with foam dressings has received broad recognition for its ability to support incision healing for a variety of surgical procedures. Over time, these dressings have evolved to include linear and ‘area’ shapes to better conform to different incision types and surface geometries. To address new studies on these configurations and provide guidance for dressing selection, an international, multidisciplinary panel of experts was convened. The panel reviewed recent publications on ciNPT with reticulated open cell foam (ROCF) dressings, shared their cases and experiences and engaged in roundtable discussions on benefits, drawbacks and technical challenges. Topics were ranked by importance and refined into potential consensus statements. These were shared for anonymous feedback, requiring 80% agreement for consensus. This manuscript establishes 12 consensus statements regarding risk factors supporting the use of ciNPT, conditions supporting preference of linear or area ciNPT dressings and tips for practical application of ciNPT with ROCF dressings. While this consensus panel expands on previous publications to aid clinicians' decision-making, further research is needed to refine recommendations and identify the strengths and limitations of ciNPT. Continued multidisciplinary collaboration will ensure ciNPT remains vital for improving surgical outcomes and patient care.

The changing role of substances: trends, characteristics of individuals and prior healthcare utilization among individuals with accidental substance-related toxicity deaths in Ontario Canada

by Shaleesa Ledlie, Alice Holton, Pamela Leece, Bisola Hamzat, Joanna Yang, Gillian Kolla, Nikki Bozinoff, Rob Boyd, Mike Franklyn, Ashley Smoke, Paul Newcombe, Tara Gomes

Objective

To investigate trends and the circumstances surrounding fatal substance-related toxicities directly attributed to alcohol, stimulants, benzodiazepines or opioids and combinations of substances in Ontario, Canada.

Methods

We conducted a population-based cross-sectional study of all accidental substance-related toxicity deaths in Ontario, Canada from January 1, 2018 to June 30, 2022. We reported monthly rates of substance-related toxicity deaths and investigated the combination of substances most commonly involved in deaths. Demographic characteristics, location of incident, and prior healthcare encounters for non-fatal toxicities and substance use disorders were examined.

Results

Overall, 10,022 accidental substance-related toxicity deaths occurred, with the annual number of deaths nearly doubling between the first and last 12 months of the study period (N = 1,570–2,702). Opioids were directly involved in the majority of deaths (84.1%; N = 8,431), followed by stimulants (60.9%; N = 6,108), alcohol (13.4%; N = 1,346) and benzodiazepines (7.8%; N = 782). In total, 56.9% (N = 5,698) of deaths involved combinations of substances. Approximately one-fifth of individuals were treated in a hospital setting for a substance-related toxicity in the past year, with the majority being opioid-related (17.4%; N = 1,748). Finally, 60.9% (N = 6,098) of people had a substance use disorder diagnosis at time of death.

Conclusions

Our study shows not only the enormous loss of life from substance-related toxicities but also the growing importance of combinations of substances in these deaths. A large proportion of people had previously interacted within an hospital setting for prior substance-related toxicity events or related to a substance use disorder, representing important missed intervention points in providing appropriate care.

The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study

Por: Lameire · D. L. · Noori · A. · Abbas · A. · Persitz · J. · Baltzer · H. · Collett · E. · Veillette · C. · Chan · A. · Paul · R.
Introduction

Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient’s satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.

Methods and analysis

The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.

Ethics and dissemination

This study was approved by the University Health Network Research Ethics Board (REB 23–5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.

Trial registration number

Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.

Protocol version

Version 2.0: August 26, 2024.

❌